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IMMUNOCELLULAR THERAPEUTICS, LTD.

Date Filed : Apr 05, 2011

S-11ds1.htmREGISTRATION STATEMENT ON FORM S-1Registration Statement on Form S-1
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As filed with the Securities and Exchange Commission on April 5, 2011

File No. 333-            

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM S-1

REGISTRATION STATEMENT

Under

The Securities Act of 1933

 

 

ImmunoCellular Therapeutics, Ltd.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware 2834 93-1301885

(State or other jurisdiction of

incorporation or organization)

 

(Primary Standard Industrial

Classification Code Number)

 

(I.R.S. Employer

Identification No.)

 

21900 Burbank Boulevard

Woodland Hills, California 91367

(818) 992-2907

(Address, including zip code and telephone

number, including area code, of registrant’s

principal executive offices)

 

Dr. Manish Singh

ImmunoCellular Therapeutics, Ltd.

21900 Burbank Boulevard

Woodland Hills, California 91367

(818) 992-2907

(Name, address, including zip code and telephone

number, including areacode, of agent for service)

 

 

 

Copies to:

Sanford J. Hillsberg

Marc Brown

TroyGould PC

Suite 1600

1801 Century Park East

Los Angeles, California 90067

 

 

Approximatedate of commencement of proposed sale to public: From time to time after the effective date of this registration statement, as shall be determined by the selling stockholders identified herein.

If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 underthe Securities Act of 1933, check the following box:    x

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, pleasecheck the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering:    ¨

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and listthe Securities Act registration statement number of the earlier effective registration statement for the same offering:    ¨

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and listthe Securities Act registration statement number of the earlier effective registration statement for the same offering:    ¨

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smallerreporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (Check one):

 

Large accelerated filer ¨  Accelerated filer ¨
Non-accelerated filer ¨  (Do not check if a smaller reporting company)  Smaller reporting company x

 

 

CALCULATION OFREGISTRATION FEE

 

 

Title of each class of

securities to be registered

 

Amount

to be

Registered(1)

 

Proposed

Maximum

Offering Price

Per Security(2)

 

Proposed

Maximum
Aggregate

Offering Price

 Amount of
Registration Fee

Common Stock, par value $0.0001 per share

 5,219,768 $2.25 $11,744,478 $1,363,54

Common Stock, par value $0.0001 per share underlying warrants

 2,818,689 $2.25 $6,342,050 $736.31

Total

 8,038,457   $18,086,528 $2,099.85
 
 

 

(1)In the event of a stock split, reverse stock split, stock dividend or similar transaction involving our common stock, the number of shares registered shallautomatically be adjusted to cover the additional shares of stock issuable pursuant to Rule 416 under the Securities Act.
(2)Estimated solely for purposes of calculating the registration fee in accordance with Rule 457(c) under the Securities Act, using the average of the high and low pricesas reported on the Over the Counter Bulletin Board on April 4, 2011, which was $2.25 per share.

 

 

TheRegistrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this Registration Statement shallthereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.

 

 

 


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The information contained in this prospectus is not complete and may be changed. The sellingsecurityholders named in this prospectus may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell securities, and the sellingsecurityholder is not soliciting offers to buy these securities, in any state where the offer or sale is not permitted.

PRELIMINARY PROSPECTUS

Subject toCompletion. Dated April 5, 2011

ImmunoCellular Therapeutics, Ltd.

8,038,457 Shares of Common Stock

 

 

This prospectusrelates to the resale of up to 5,219,768 shares of our currently outstanding common stock that are owned by some of our stockholders and 2,818,689 shares of our common stock issuable upon the exercise of warrants held by some of our securityholdersnamed in this prospectus. These shares of common stock and warrants were issued to the selling securityholders in connection with a private placement that we completed in February 2011. We are not selling any shares of common stock in this offeringand therefore will not receive any proceeds from this offering. We will, however, receive the exercise price of the warrants if and when these warrants are exercised by the selling securityholders. We will pay the expenses of registering theseshares.

Our common stock is traded in the over-the-counter market and is quoted on the OTC Bulletin Board under the symbolIMUC. On April 4, 2011, the last reported price of our common stock was $2.25 per share.

The shares included in thisprospectus may be reoffered and resold directly by the selling securityholders in accordance with one or more of the methods described in the “Plan of Distribution,” which begins on page 60 of this prospectus. We will not control ordetermine the price at which the selling securityholders decide to sell their shares. Brokers or dealers effecting transactions in these shares should confirm that the shares are registered under applicable state law or that an exemption fromregistration is available.

 

 

You should understand the risks associated with investing in our common stock. Before making an investment, read the “Risk Factors,” which begin on page 3 of this prospectus.

Neither the Securities and Exchange Commission nor anystate securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

 

 

The date of this prospectus is             , 2011


Table of Contents

TABLE OF CONTENTS

 

   Page 

PROSPECTUS SUMMARY

   1  

RISK FACTORS

   3  

FORWARD-LOOKING STATEMENTS

   17  

USE OF PROCEEDS

   18  

BUSINESS

   18  

MARKET PRICE OF AND DIVIDENDS ON COMMON EQUITY AND RELATED STOCKHOLDER MATTERS

   30  

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OFOPERATIONS

   32  

DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS

   36  

EXECUTIVE COMPENSATION

   43  

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

   53  

SELLING SECURITYHOLDERS

   55  

PLAN OF DISTRIBUTION

   61  

DESCRIPTION OF SECURITIES

   63  

DISCLOSURE OF SEC POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES

   65  

LEGAL MATTERS

   66  

EXPERTS

   66  

WHERE YOU CAN FIND MORE INFORMATION

   66  

GLOSSARY OF TERMS

   67  

INDEX TO FINANCIAL STATEMENTS

   F-1  

You should rely only on theinformation contained in this prospectus. We have not authorized anyone to provide you with information different from that which is contained in this prospectus. This prospectus may be used only where it is legal to sell these securities. Theinformation in this prospectus may only be accurate on the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of securities.

 

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PROSPECTUS SUMMARY

This summary highlights information contained elsewhere in this prospectus; it does not contain all of the information you shouldconsider before investing in our common stock. You should read the entire prospectus before making an investment decision.

Throughout this prospectus, the terms “we,” “us,” “our,” and “our company” refer toImmunoCellular Therapeutics, Ltd.

Overview

ImmunoCellular Therapeutics, Ltd. is a development stage company that is seeking to develop and commercialize new therapeutics to fight cancer using the immune system. Our product candidate portfolioincludes cellular immunotherapies targeting cancer and cancer stem cell antigens, peptide based immunotherapies targeting cancer stem cells, and monoclonal antibodies to diagnose and treat several different cancers. We have completed a Phase Iclinical trial of our dendritic cell based vaccine product candidate (ICT-107) to treat newly diagnosed glioblastoma multiforme (GBM) that was initiated in May 2007, and we initiated a multicenter Phase II clinical trial of this vaccine in January2011. This product candidate may also be efficacious in the treatment of recurrent GBM, and we are planning to initiate a pilot trial of this vaccine for this indication in 2011. Another one of our vaccine product candidates is a peptide basedoff-the-shelf vaccine (ICT-121) to target multiple solid tumors which is undergoing preclinical development. This vaccine targets cancer stem cells, which are believed by many scientists to be roots of cancer, and may be applicable in multiplecancer indications. In addition, we have several monoclonal antibody product candidates targeting small cell lung cancer, pancreatic cancer, multiple myeloma and ovarian cancer. Through two important acquisitions in the last five years, we arebuilding capabilities to develop new cancer immunotherapeutic products harnessing mechanisms of immune system surveillance in the human body.

In November 2006, we acquired an exclusive, worldwide license from Cedars-Sinai Medical Center to certain technology for use as cellular-based therapies, including dendritic cell-based vaccines forneurological disorders that include brain tumors and neurodegenerative disorders and other cancers. This technology is covered by a number of pending U.S. and foreign patent applications. In June 2008, we licensed an additional technology fromCedars-Sinai to target cancer stem cells that may be applicable for brain tumors as well as several other cancer indications.

In February 2008, we entered into an agreement with Molecular Discoveries LLC, a New York limited liability company, covering ouracquisition of certain monoclonal antibody related technology owned by Molecular Discoveries and completed the acquisition of the technology on that date. The technology acquired under the Molecular Discoveries agreement and now owned by us consistsof (i) a platform technology referred to by Molecular Discoveries as DIAAD for the potentially rapid discovery of targets (antigens) and monoclonal antibodies for diagnosis and treatment of diverse human diseases and (ii) certainmonoclonal antibody candidates for the potential detection and treatment of multiple myeloma, small cell lung, pancreatic and ovarian cancers. The monoclonal antibodies are covered by issued patents and pending patent applications in the fields ofmultiple myeloma, small cell lung and ovarian cancers.

We do not currently anticipate that we will derive any revenues fromeither product sales or licensing during the foreseeable future. We do not have any bank credit lines and have financed substantially all of our prior operations through the sale of securities, including a private placement of our securities that wecompleted in February 2011 that generated $8,090,644 of proceeds for us (before commissions and offering expenses).

Theestimated cost of completing the development of either of our current vaccine product candidates and of obtaining all required regulatory approvals to market either of those product candidates is substantially greater than the amount of funds wecurrently have available. We believe that our existing cash balances,

 

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together with potential proceeds from our preferred stock purchase arrangement with Socius Capital Group, LLC, will be sufficient to fund our currently planned level of operations for at leastthe next twelve months. We will seek to obtain additional funds through various financing sources, including possible sales of our securities, and in the longer term through strategic alliances with other pharmaceutical or biopharmaceuticalcompanies, but there can be no assurance that we will be able to obtain any additional funding from any potential financing sources, or create any such alliances, or that the terms under which we would obtain any funding will be sufficient to fundour operations.

Company History

We filed our original Certificate of Incorporation with the Secretary of State of Delaware on March 20, 1987 under the name Redwing Capital Corp. On June 16, 1989, we changed our name to PatcoIndustries, Ltd. and conducted an unrelated business under that name until 1994. On January 30, 2006, we amended our Certificate of Incorporation to change our name to Optical Molecular Imaging, Inc. in connection with our merger onJanuary 31, 2006 with Spectral Molecular Imaging, Inc. On November 2, 2006, we amended our Certificate of Incorporation to change our name to ImmunoCellular Therapeutics, Ltd. to reflect our disposition of our Spectral Molecular Imagingsubsidiary and our acquisition of our cellular-based technology from Cedars-Sinai.

Our principalexecutive offices are located at 21900 Burbank Boulevard,3rd Floor, Woodland Hills, California 91367, and ourtelephone number at that address is (818) 992-2907.

The Offering

This offering involves 8,038,457 shares of our common stock issued or issuable to the selling securityholders, consisting of 5,219,768shares of our common stock and 2,609,898 shares of our common stock issuable upon exercise of warrants to purchase shares of our common stock that we issued in a private placement in February 2011 to 41 investors and 208,791 shares of our commonstock issuable upon exercise of warrants to purchase shares of our common stock that we issued to the placement agents for that private placement.

 

Common stock offered by the selling securityholders

   8,038,457 (1) 

Common stock currently outstanding

   28,725,624 (2) 

Common stock to be outstanding after the offering, assuming no exercise of the warrants for the shares covered by thisprospectus

   28,725,624 (2) 

Common stock to be outstanding after the offering, assuming the exercise of all warrants for the shares covered by thisprospectus

   31,544,313 (1)(3) 

OTC Bulletin Board Trading Symbol

  IMUC

Risk Factors

  An investment in our common stock involves significant risks. See “Risk Factors” beginning on page 3.

 

(1)Includes 2,818,689 shares of common stock issuable upon exercise of outstanding warrants (with an exercise price of $2.25 per share).

 

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(2)Does not include 10,312,095 shares of common stock issuable upon the exercise of outstanding options (with exercise prices ranging from $0.25 to $1.30 per share),6,831,862 shares of common stock issuable upon the exercise of outstanding warrants (with exercise prices ranging from $1.00 to $2.50) and 24,300,000 shares of common stock issuable upon exercise of an outstanding warrant (at an exercise price equalto the market price of the common stock at the times the warrant becomes exercisable).
(3)Does not include 10,312,095 shares of common stock issuable upon the exercise of outstanding options (with exercise prices ranging from $0.25 to $1.30 per share),4,013,173 shares of common stock issuable upon the exercise of outstanding warrants (with exercise prices ranging from $1.00 to $2.50) and 24,300,000 shares of common stock issuable upon exercise of an outstanding warrant (at an exercise price equalto the market price of the common stock at the times the warrant becomes exercisable).

RISK FACTORS

An investment in our securities involves a high degree of risk. You should carefully consider the risks described below beforedeciding to invest in or maintain your investment in our company. The risks described below are not intended to be an all-inclusive list of all of the potential risks relating to an investment in our securities. If any of the following or otherrisks actually occur, our business, financial condition or operating results and the trading price or value of our securities could be materially adversely affected.

Risks Related To Our Business

We are a development-stage company subject to all of therisks and uncertainties of a new business, including the risk that we may never market any products or generate revenues.

We are a development-stage company that has only recently commenced any significant research and development activity. There is noassurance that we will be able to satisfactorily develop or market any of our current or proposed product candidates or that those product candidates will generate revenues or that any revenues generated will be sufficient for us to becomeprofitable or thereafter maintain profitability. Only one of our product candidates has been clinically tested in an early stage trial. We have not generated any recurring revenues to date, and we do not expect to generate any such revenues for anumber of years.

Our cell-based vaccine technologies are our primary platform technologies, and our commercial prospects willbe heavily dependent on the outcome of the contemplated clinical trials for our current lead vaccine product candidate (ICT-107). We have only three full-time employees, including our President and Chief Executive Officer and our Vice-President– Product Development and Manufacturing, have limited resources and may not possess the ability to successfully overcome many of the risks and uncertainties frequently encountered by early stage companies involved in the new and rapidlyevolving field of biotechnology in general and cancer immunotherapies and monoclonal antibodies in particular. You must consider that we may not be able to:

 

  

obtain additional financial resources necessary to develop, test, manufacture and market our vaccine product candidates, our monoclonal antibodyproduct candidates or any future product candidates;

 

  

engage corporate partners to assist in developing, testing, manufacturing and marketing our vaccine product candidates, our monoclonal antibody productcandidates or any future product candidates;

 

  

satisfy the requirements of acceptable pre-clinical and clinical trial protocols, including timely patient enrollment;

 

  

establish and demonstrate or satisfactorily complete the research to demonstrate at various stages the pre-clinical and clinical efficacy and safety ofour vaccine product candidates, our monoclonal antibody product candidates or any future product candidates; and

 

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market our vaccine product candidates, our monoclonal antibody product candidates or any future product candidates to achieve acceptance and use by themedical community and patients in general and produce revenues.

We have a history of losses, expect future losses andcannot assure you that we will ever become or remain profitable.

With the exception of a one-time licensing fee paymentthat we previously received in connection with our entering into a research and license option agreement covering one of our monoclonal antibody product candidates with a third party who did not subsequently exercise that option, we have notgenerated any revenues and have incurred operating losses since our inception, and we expect to continue to incur operating losses for the foreseeable future. There is no assurance that we will be able to develop or market products in the futurethat will generate revenues or that any revenues generated will be sufficient for us to become profitable or thereafter maintain profitability. In the event that our operating losses are greater than anticipated or continue for longer thananticipated, we will need to raise significant additional capital sooner, or in greater amounts, than otherwise anticipated in order to be able to continue development of our present or future product candidates and maintain our operations.

We will need to obtain significant additional capital, which additional funding may dilute our existing stockholders.

We believe that our existing cash balances will be sufficient to fund our currently planned level of operations for at least the nexttwelve months. We will need significant funding to carry out all of our development work on our vaccine product candidates, our monoclonal antibody product candidates and future product candidates and to expand the scope of our operations (includingseeking to employ additional support personnel on a full-time basis). If we are unable to obtain sufficient capital on a timely basis, the development of our current or any future product candidates is likely to be delayed, and we could be forced toreduce the scope of our research and development projects or otherwise limit or terminate our operations altogether.

InDecember 2009, we entered into an agreement with Socius Capital under which Socius Capital has agreed to purchase from time to time an aggregate of up to $10 million of our preferred stock and sold $4 million of these shares to them in May2010. However, Socius Capital’s obligation to purchase the remaining shares of our preferred stock is subject to our satisfying certain conditions at that time. There is no assurance that we will be able to satisfy those conditions if we wishto sell shares of our preferred stock to Socius Capital or that Socius Capital will have the ability to complete these purchases. In connection with each sale of preferred stock to Socius Capital, a pro rata portion of a warrant held by an affiliateof Socius Capital to purchase shares of our common stock will become exercisable. Should the Socius Capital affiliate sell substantial amounts of the underlying shares of our common stock, those sales could have a material adverse effect on thetrading market for our common stock and make it impractical for us to make future sales of preferred stock to Socius Capital without substantial dilution to our existing shareholders.

Except for our financing agreement with Socius Capital, we have not identified the sources for the additional financing that we willrequire, and we do not have commitments from any third parties to provide this financing. Certain investors may be unwilling to invest in our securities since we are traded on the OTC Bulletin Board and not on a national securities exchange,particularly if there is only limited trading in our common stock on the OTC Bulletin Board at the time we seek financing. The volume and frequency of such trading has been limited to date. There is no assurance that sufficient funding through afinancing will be available to us at acceptable terms or at all. Any additional funding that we obtain in a financing is likely to reduce the percentage ownership of the company held by our existing securityholders. The amount of this dilution maybe substantially increased if the trading price of our common stock has declined at the time of any financing from its current levels. We may seek SBIR or other government grants to conduct a portion of our planned research and development work inaddition to certain equity financing. Except for one recently awarded grant under a federal tax credit/grant program for pharmaceutical research and development

 

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companies and one recently submitted grant application under the Orphan Drug Act, we have not yet submitted any requests for these grants, the competition for obtaining these grants is intenseand there is no assurance that we will secure any grant funding on a timely basis or at all.

Our access to Dr. Yu’s researchlaboratory at Cedars-Sinai may be limited.

We are heavily dependent upon Dr. John Yu, both for past research and aswe develop our lead vaccine product candidates or any other or future vaccine product candidates. His laboratory at Cedars-Sinai has been financed in part by Cedars-Sinai (which is the licensor of our cellular-based therapy technology) and theNational Institutes of Health (“NIH”). Cedars-Sinai or the NIH or other governmental agencies could promulgate new rules and regulations that might interfere with our product development or ownership rights if we wish to access on acontractual basis Dr. Yu’s laboratory at Cedars-Sinai in connection with our research and development activities.

Our currentproduct candidates and any future product candidates will be based on novel technologies and are inherently risky.

We aresubject to the risks of failure inherent in the development of products based on new technologies. The novel nature of our therapies creates significant challenges in regards to product development and optimization, manufacturing, governmentregulation, third-party reimbursement and market acceptance. For example, the FDA has limited experience with cancer stem cell or dendritic cell-based therapeutics and, with the exception of one dendritic cell-based vaccine for the treatment ofprostrate cancer, has not yet approved any of these therapeutics for marketing, and the pathway to regulatory approval for our vaccine product candidates or any future vaccine product candidates may accordingly be more uncertain, complex and lengthythan the pathway for new conventional drugs. The targeting of cancer stem cells as a potential therapy is a recent development that may not become broadly accepted by scientists or pharmaceutical companies. In addition, the manufacture of biologicalproducts, including cancer stem cell or dendritic cell-based vaccines, could be more complex and difficult, and therefore, these potential challenges may prevent us from developing and commercializing products on a timely or profitable basis or atall.

We may elect to delay or discontinue preclinical studies or clinical trials based on unfavorable results. Any productcandidate using a cellular therapeutic technology may fail to:

 

  

survive and persist in the desired location;

 

  

provide the intended therapeutic benefits;

 

  

properly integrate into existing tissue in the desired manner; or

 

  

achieve therapeutic benefits equal to or better than the standard of treatment at the time of testing.

In addition, our product candidates may cause undesirable side effects. Results of preclinical research with our vaccine productcandidates or any other or future product candidates or clinical results with formulations used in earlier trials that are similar but not identical to our product candidate formulations may not be indicative of the results that will be obtained inlater stages of preclinical or clinical research on our product candidates. In particular, the results generated in our Phase I trial of ICT-107 covered a small number of patients at a single trial site and may not be indicative of the results thatwill be obtained in our current multi-center Phase II trial of a new, optimized formulation of ICT-107. If regulatory authorities do not approve our products or if we fail to maintain regulatory compliance, we would be unable to commercialize ourproducts, and our business and results of operations would be harmed. Furthermore, because cancer stem cell and dendritic cell based products represent new forms of therapy, the marketplace may not accept any products we may develop that utilizethese technologies. If we do succeed in developing products, we will face many potential obstacles, such as the need to obtain regulatory approvals and to develop or obtain manufacturing, marketing and distribution capabilities. In addition, we willface substantial additional risks, such as product liability claims.

 

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Because of the early stage of development of our vaccine product candidates, we do not knowif we will be able to generate data that will support the filing of a biologics license or new drug application for these product candidates or the FDA’s approval thereof. If we experience substantial delays, we may not have the financialresources to continue development of these product candidates or the development of any of our other or future product candidates. Delays in clinical trials could reduce the commercial viability of our vaccine product candidates and any other orfuture product candidates. Delays in patient enrollment may be caused by a number of factors, including patient reluctance to participate in blinded trials where the patient is not assured of receiving the treatment being tested in the trial.

We are required to pay substantial royalties under our license agreement with Cedars-Sinai, and we must meet certain milestones tomaintain our license rights.

Under our license agreement with Cedars-Sinai for our cellular-based therapy technology, wewill be required to pay substantial royalties to that institution based on our revenues from sales of our products utilizing this technology, and these royalty payments could adversely affect the overall profitability for us of any products that wemay seek to commercialize. In order to maintain our license rights under the Cedars-Sinai license agreement, we will need to meet certain specified milestones, subject to certain cure provisions, in the development of our vaccine product candidatesand in the raising of funding. There is no assurance that we will be successful in meeting all of the milestones in the future on a timely basis or at all.

Before we can market our vaccine product candidates or any other or future product candidates, we must obtain governmental approval for each of these product candidates, the application and receipt ofwhich is time-consuming, costly and uncertain.

Our current product candidates and any future product candidates that wewill be developing will require approval of the U.S. Food and Drug Administration (“FDA”) before they can be marketed in the U.S. Although our focus at this time is primarily on the U.S. market, in the future similar approvals will need tobe obtained from foreign regulatory agencies before we can market our current and proposed product candidates in other countries. The process for filing and obtaining FDA approval to market therapeutic products is both time-consuming and costly,with no certainty of a successful outcome. The historical failure rate for companies seeking to obtain FDA approval of therapeutic products is high and, with the exception of Dendreon Corp.’s dendritic cell vaccine for the treatment of prostatecancer, no cancer stem cell or dendritic cell-based cancer vaccine has to date been approved by the FDA. This process includes conducting extensive pre-clinical research and clinical testing, which may take longer and cost more than we initiallyanticipate due to numerous factors, including without limitation, difficulty in securing appropriate centers to conduct trials, difficulty in enrolling patients in conformity with required protocols in a timely manner, unexpected adverse reactionsby patients in the trials to our proposed product candidates and changes in the FDA’s requirements for our testing during the course of that testing.

The FDA may require pre-clinical work for our monoclonal antibody product candidates beyond what we currently plan to conduct, which could necessitate significant expenditures on our part that we have notbudgeted and which could significantly delay the commencement of clinical trials for these product candidates. The formulation of our cancer stem cell vaccine product candidate needs to be completed and certain animal testing must be successfullycompleted with this formulation before we can test this product candidate in humans. Our cancer stem cell vaccine product candidate has not been previously tested in patients, and we may encounter unexpected and adverse immune responses or otherside effects in the patients whom we test with this product candidate.

The time required to obtain FDA and other approvals isunpredictable but often can exceed five years following the commencement of clinical trials, depending upon the complexity of the product and other

 

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factors. Any analysis we perform of data from preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or preventregulatory approval. We may also encounter unexpected delays or increased costs due to a variety of reasons, including new government regulations from future legislation or administrative action, or from changes in FDA policy during the period ofproduct development, clinical trials and FDA regulatory review.

Any delay or failure in our clinical trial program and inobtaining required approvals would have a material adverse effect on our ability to generate revenues from the particular product. Furthermore, any regulatory approval to market a product may be subject to limitations on the indicated uses for whichwe may market the product. These limitations may limit the size of the market for the product.

Certain of our current product candidatesmay not be eligible for Orphan Drug status.

The United States and Europe may designate drugs for relatively small patientpopulations as orphan drugs. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process, but does make the product eligible for orphan drug exclusivity, reduced filing fees andspecific tax credits. Generally, if a company receives the first marketing approval for a product with an orphan drug designation in the clinical indication for which it has such designation, the product is entitled to orphan drug exclusivity.Orphan drug exclusivity means that the FDA will not approve another application to market the same drug for the same indication, except in limited circumstances, for a period of seven years in the United States. This exclusivity, however, couldblock the approval of our proposed product candidates if a competitor obtains marketing approval before us. We have obtained orphan drug status for our dendritic cell vaccine (ICT-107) to treat glioblastoma multiforme and may also seek this statusfor our cancer stem cell vaccine to treat glioblastoma multiforme and other diseases if we meet the eligibility criteria. However, even if we obtain orphan drug exclusivity for any of our proposed product candidates, we may not be able to maintainit. For example, if a competitive product is shown to be clinically superior to our product, any orphan drug exclusivity we have will not block the approval of such competitive product.

Fast Track designation for development of our vaccine product candidates or any other potential product candidate may not lead to a faster development or regulatory review or approval process, and itdoes not increase the likelihood that our product candidates will receive marketing approval.

If a drug is intended forthe treatment of a serious or life-threatening condition and the drug demonstrates the potential to address unmet medical needs for this condition, the drug sponsor may apply for FDA Fast Track designation for a particular indication. Marketingapplications filed by sponsors of products in Fast Track development may qualify for priority review under the policies and procedures offered by the FDA, but the Fast Track designation does not assure any such qualification or ultimate marketingapproval by the FDA. Receipt of Fast Track designation may not result in a faster development process, review or approval compared to drugs considered for approval under conventional FDA procedures. In addition, the FDA may withdraw any Fast Trackdesignation at any time. We may seek Fast Track designation for our vaccine product candidates or any other product candidates, but there is no assurance that the FDA will grant this status to any of our proposed product candidates.

Because our current product candidates represent and our other future potential product candidates will represent novel approaches to the treatment ofdisease, there are many uncertainties regarding the development, the market acceptance, third-party reimbursement coverage and the commercial potential of our product candidates.

There is no assurance that the approaches offered by our current product candidates or any future product candidates will gain broadacceptance among doctors or patients or that governmental agencies or third-party medical insurers will be willing to provide reimbursement coverage for proposed product candidates. Moreover, we do not have internal marketing data research resourcesand are not certain of and have not attempted to independently verify the potential size of the commercial markets for our current product candidates or any future product candidates. Since our current product candidates and any future product

 

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candidates will represent new approaches to treating various conditions, it may be difficult, in any event, to accurately estimate the potential revenues from these product candidates. We mayspend large amounts of money trying to obtain approval for these product candidates, and never succeed in doing so. In addition, these product candidates may not demonstrate in large sets of patients the pharmacological properties ascribed to themin the laboratory studies or smaller groups of patients, and they may interact with human biological systems in unforeseen, ineffective or even harmful ways either before or after they are approved to be marketed. We do not yet have sufficientinformation to reliably estimate what it will cost to commercially manufacture our current product candidates or any future product candidates, and the actual cost to manufacture these products could materially and adversely affect the commercialviability of these products. Certain of our cell-based vaccine product candidates may be formulated with cells harvested and processed from individual target patients, which could limit the target patient population for these vaccines and couldrequire complex and costly manufacturing processes to produce these vaccines on a commercial basis. As a result, we may never succeed in developing a marketable product. If we do not successfully develop and commercialize products based upon ourapproach, we will not become profitable, which would materially and adversely affect the value of our common stock.

Otherfactors that are presently unknown to us that we believe will materially affect market acceptance of our current product candidates or any future product candidates include:

 

  

the timing of our receipt of any marketing approvals, the terms of any approvals and the countries in which approvals are obtained;

 

  

the safety, efficacy and ease of administration;

 

  

the availability of government and third-party payor reimbursement;

 

  

the pricing of our product candidates, particularly as compared to alternative treatments; and

 

  

the availability of alternative effective forms of treatments, at that time, for the diseases that the product candidates we are developing areintended to treat.

Adverse publicity regarding cellular therapies could impact our business.

Although we are not utilizing embryonic stem cells, adverse publicity due to the ethical and social controversies surrounding the use ofsuch cells or any adverse reported side effects from any stem cell, dendritic or other cell therapy clinical trials or to the failure of such trials to demonstrate that these therapies are efficacious could materially and adversely affect ourability to raise capital or recruit managerial or scientific personnel or obtain research grants.

As an early stage small company thatwill be competing against numerous large, established companies that have substantially greater financial, technical, manufacturing, marketing, distribution and other resources than we have, we will be at a significant competitive disadvantage.

The pharmaceutical and biopharmaceutical industry is characterized by intense competition and rapid and significanttechnological changes and advancements. Many companies, research institutions and universities are doing research and development work in a number of areas similar to those that we focus on that could lead to the development of new products whichcould compete with and be superior to our product candidates.

Most of the companies with which we compete have substantiallygreater financial, technical, research, manufacturing, marketing, distribution and other resources than those of ours. A number of these companies may have or may develop technologies for developing products for treating various diseases, includingbrain cancers, that could prove to be superior to ours. We expect technological developments in the

 

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pharmaceutical and biopharmaceutical and related fields to occur at a rapid rate, and we believe competition will intensify as advances in these fields are made. Accordingly, we will be requiredto continue to devote substantial resources and efforts to research and development activities in order to potentially achieve and maintain a competitive position in this field. Products that we develop may become obsolete before we are able tomarket them or to recover all or any portion of our research and development expenses. We will be competing with respect to our products with companies that have significantly more experience and expertise in undertaking preclinical testing andhuman clinical trials with new or improved therapeutic products and obtaining regulatory approvals of such products. A number of these companies already market and may be in advanced phases of clinical testing of various drugs that will or maycompete with our current product candidates or other future potential product candidates. Our competitors may develop or commercialize products more rapidly than we do or with significant advantages over any products we develop. Our competitors maytherefore be more successful in commercializing their products than we are, which could adversely affect our competitive position and business.

In addition to larger pharmaceutical or biopharmaceutical companies that may develop different competing technologies or technologies within the cellular and stem cell field, we will be competing with anumber of smaller biotechnology companies that are focused on cellular therapy and cancer vaccine technologies, which may include among others Dendreon, Northwest Biotherapeutics, Antigenics, Celldex Therapeutics, NeuralStem, Geron, NeuroNova,ReNeuron, Stemcells, Inc., Advanced Cell Technology and Osiris Therapeutics. Dendreon has received FDA marketing approval for a prostate cancer vaccine utilizing dendritic cells, Northwest Biotherapeutics is developing a dendritic cell-based vaccinefor treating brain tumors, and Celldex Therapeutics has recently completed a Phase II clinical trial to treat glioblastoma with their cancer vaccine. Other existing and new companies that may enter the field may also be developing vaccines of thistype.

Drugs targeting cancer stem cells is a new emerging field, and a number of companies are developing products that arein various stages of clinical or preclinical development. We will be competing with these companies, which may have more resources than we have. This list may include among others ChemGenex, GlaxoSmithKline, Geron, Stemline Therapeutics, OncoMedPharmaceuticals, Raven and Arius Research. In addition, a number of academic and research centers are doing research in this area which may be commercialized by new or existing companies.

A number of monoclonal antibody products currently are being marketed for the treatment of cancer, including Rituxan®,Herceptin®, Compath®, Avastin®, Erbitux®, Vectibix®, Zevatin®, and Bexxar®, and numerous other monoclonal antibody based products are under development for the treatment of cancer. Accordingly, our monoclonal antibodyproducts, if marketed, can be expected to compete with a number of monoclonal antibody products (as well as other products for the treatment of cancer) that are well established and marketed by substantial organizations.

Colleges, universities, governmental agencies and other public and private research organizations are becoming more active in seekingpatent protection and licensing arrangements to collect royalties for use of technologies that they have developed, some of which may be directly competitive with our lead product candidate or any future product candidates. The governments of anumber of foreign countries are aggressively investing in cellular therapy research and promoting such research by public and private institutions within those countries. These domestic and foreign institutions and governmental agencies, along withpharmaceutical and specialized biotechnology companies, also can be expected to compete with us in recruiting qualified scientific personnel.

 

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We will need to outsource and rely on third parties for the clinical development and manufacture, salesand marketing of our current product candidates or any future product candidates, and our future success will be dependent on the timeliness and effectiveness of the efforts of these third parties.

We do not have the required financial and human resources to carry out on our own all the pre-clinical and clinical development for ourvaccine product candidates or any other or future product candidates, and do not have the capability and resources to manufacture, market or sell our current product candidates or any future product candidates. Vaccines are often administered withone or more adjuvants, which if necessary we will have to procure from a third-party source. We will need to rely on a firm with expertise in producing a humanized form of our monoclonal antibody product candidates. Our business model calls for theoutsourcing of the clinical and other development and manufacturing, sales and marketing of our product candidates in order to reduce our capital and infrastructure costs as a means of potentially improving our financial position. We currently areseeking a partner or licensee to be responsible for the early stage development of our monoclonal antibody product candidates. Since we do not have any significant efficacy data for these product candidates, it will be more difficult for us toobtain partners or licensees on attractive terms or at all at this stage. Accordingly, we will seek to enter, at the appropriate time, into agreements with other companies that can assist us and provide certain capabilities that we do not possess.Even if we do succeed in securing these alliances, we may not be able to maintain them if, for example, development results are disappointing or approval of a product is delayed or sales of an approved product are below expectations. Furthermore,any delay in entering into agreements could delay the development and commercialization of our products and reduce their competitiveness even if they reach the market. Any such delay related to our agreements could adversely affect our business.

If any party to which we have outsourced certain functions fails to perform its obligations under agreements with us, the development andcommercialization of our lead product candidate and any future product candidates could be delayed or terminated.

To theextent that we rely on third-party individuals or other companies to manage the day-to-day conduct of our clinical trials or to manufacture, sell or market our current product candidates or any future product candidates, we will be dependent on thetimeliness and effectiveness of their efforts. If a clinical research management organization that we might utilize is unable to allocate sufficient qualified personnel to our studies or if the work performed by it does not fully satisfy therigorous requirements of the FDA, we may encounter substantial delays and increased costs in completing our clinical trials. If a firm producing humanized forms of our monoclonal antibody product candidates or a manufacturer of the raw material orfinished product for our clinical trials is unable to meet our time schedules or cost parameters, the timing of our clinical trials and development of our product candidates may be adversely affected. Any manufacturer that we select may encounterdifficulties in scaling-up the manufacture of new products in commercial quantities, including problems involving product yields, product stability or shelf life, quality control, adequacy of control procedures and policies, compliance with FDAregulations and the need for further FDA approval of any new manufacturing processes and facilities. The manufacture of clinical supplies for studies and commercial quantities of our current product candidates and any future product candidates arelikely to be inherently more difficult and costly than typical chemical pharmaceuticals. This could delay commercialization of any of our product candidates or reduce the profitability of these candidates for us. If any of these occur, thedevelopment and commercialization of our product candidates could be delayed, curtailed or terminated because we may not have sufficient financial resources or capabilities to continue such development and commercialization on our own.

If we or our manufacturers or service providers fail to comply with regulatory laws and regulations, we or they could be subject to enforcementactions, which could affect our ability to market and sell our vaccine product candidates and any other or future product candidates and may harm our reputation.

If we or our collaborators, manufacturers or service providers fail to comply with applicable federal, state or foreign laws or regulations, we could be subject to enforcement actions, which could affectour ability to develop, market and sell our current product candidates or any future product candidates under development

 

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successfully and could harm our reputation and lead to reduced or non-acceptance of our proposed product candidates by the market. Even technical recommendations or evidence by the FDA throughletters, site visits, and overall recommendations to academia or biotechnology companies may make the manufacturing of a clinical product extremely labor intensive or expensive, making the product candidate no longer viable to manufacture in a costefficient manner. The very nature of the product may make the product candidate not commercially viable. The required testing of the product candidate may make that candidate no longer commercially viable. The conduct of clinical trials may becritiqued by the FDA, or a clinical trial site’s Institutional Review Board or Institutional Biosafety Committee; which may delay or make impossible clinical testing of a product candidate. The Data Safety Monitoring Committee for a clinicaltrial established by us may stop a trial or deem a product candidate unsafe to continue testing. This may have significant negative repercussions on the value of the product candidate and may have negative repercussions on the company and on theshareholders.

Even if we obtain regulatory approvals, our products will be subject to ongoing regulatory review.

Following any initial regulatory approval of any products we may develop, we will also be subject to continuing regulatory review,including the review of adverse drug experiences and clinical results that are reported after our products are made commercially available. This would include results from any post-marketing tests or vigilance required as a condition of approval.The manufacturer and manufacturing facilities we use to make any of our products will also be subject to periodic review and inspection by the FDA. The discovery of any previously unknown problems with the product, manufacturer or facility mayresult in restrictions on the product or manufacturer or facility, including withdrawal of the product from the market. We do not have, and currently do not intend to develop, the ability to manufacture material for our clinical trials or on acommercial scale. Reliance on third-party manufacturers entails risks, including the continuation of a contractual or other relationship with the third-party manufacturer, and reliance on the third-party manufacturer for regulatory compliance. Ourproduct promotion and advertising also will be subject to regulatory requirements and continuing FDA review.

The potentialramifications are far-reaching if there are areas identified as out of compliance by regulatory agencies, including, but not limited to, significant financial penalties, manufacturing and clinical trial consent decrees, commercializationrestrictions or other restrictions and litigation.

Our patents may not protect the proprietorship of our products.

Our ability to compete successfully will depend significantly on our ability to defend patents that may have issued, obtain new patents,protect trade secrets and operate without infringing the proprietary rights of others or others infringing on our proprietary rights. Although Cedars-Sinai as our licensor has filed applications relative to our cancer vaccine technology, we areresponsible going forward to prosecute these patent applications. We do not currently own or have licensed rights to any issued patents covering our cancer vaccine technology, and there is no guarantee that these patent applications will lead toissued patents.

Issuance of patents based upon the various patent applications licensed from Cedars-Sinai will depend uponthe U.S. and foreign patent agencies being able to determine that the claims made in these applications were not already publicly known or were not obvious from prior published patents and literature, including the extensive previous vaccine workperformed and published by Dr. John Yu and other researchers at Cedars-Sinai. We have recently filed a provisional patent application covering our cancer stem cell vaccine product candidate. Another patent application that we licensed fromCedars-Sinai and that we have been pursuing was rejected by the U.S. Patent and Trademark Office based on prior art. This patent application covers the treatment of brain and other cancers by a combination of a dendritic cell-based vaccine andchemotherapy. We are seeking patent protection for our dendritic cell-based vaccine product candidate primarily through our licensed multiple antigen patent application. We are not dependent on any of the claims in the combination therapyapplication being granted in order to complete the development of or to commercialize either of our cancer vaccine product candidates. We may in the future elect to abandon one of more of our pending patent applications that do not providesignificant coverage for the product candidates or technologies that we have focused on for strategic purposes.

 

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Even if we are able to obtain patent protection for our vaccine product candidates or any ofour other or future product candidates, there is no guarantee that the coverage of these patents or the existing patents we own covering our monoclonal antibody based technology will be sufficiently broad to protect us from competitors or that wewill be able to enforce our patents against potential infringement by third parties. Patent litigation is expensive, and we may not be able to afford the costs. We may not become aware on a timely basis that products we are developing or marketinginfringe the rights of others, nor may we be able to detect unauthorized use or take appropriate and timely steps to enforce our own intellectual property rights. Protecting our intellectual property rights may also consume significant managementtime and resources.

Dr. John Yu, a co-inventor of our cellular-based therapy technology who serves as our Chairman ofthe Board, is employed by Cedars-Sinai, which may assert that future intellectual property generated by Dr. Yu belongs to that institution rather than to us, and we may be required to seek a license from Cedars-Sinai for any such rights. Weacquired our monoclonal antibody related technology from Molecular Discoveries, but third parties who previously employed that company’s lead scientist could potentially assert ownership claims to the technology. We do not have any issuedpatents or patent applications covering DIAAD and may not be able to protect this technology through any trade secrets that we may hold or future patents, if any, that we may seek to obtain.

Nondisclosure agreements with employees and third parties may not adequately prevent disclosure of trade secrets and other proprietary information.

In order to protect our proprietary technology and processes, we will also rely in part on nondisclosure agreements with our employees,licensing partners, consultants, agents and other organizations to which we disclose our proprietary information. These agreements may not effectively prevent disclosure of confidential information, may be limited as to their term, and may notprovide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover trade secrets and proprietary information, and in such cases we could not assert any trade secret rightsagainst such party. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive businessposition. Since we will rely on trade secrets and nondisclosure agreements, in addition to patents, to protect some of our intellectual property, there is a risk that third parties may obtain and improperly utilize our proprietary information to ourcompetitive disadvantage. We may not be able to detect unauthorized use or take appropriate and timely steps to enforce our intellectual property rights.

The manufacture, use or sale of our current product candidates or any future product candidates may infringe on the patent rights of others, and we may be forced to litigate if an intellectual propertydispute arises.

Should third parties patent specific cells, systems, receptors, monoclonal antibodies or other items thatwe are seeking to utilize in our development activities, we may be forced to license rights from these parties or abandon our development activities if we are unable to secure these rights on attractive terms or at all. In light of the large numberof companies and institutions engaged in research and development in the cellular therapy and monoclonal antibody fields, we anticipate that many parties will be seeking patent rights for many cellular or monoclonal antibody based technologies andthat licensing and cross licensing of these rights among various competitors may arise. Our dendritic cell-based vaccine product candidate utilizes six antigens for which we will be required to obtain licenses from one or more other parties beforewe can commercialize this product candidate. There is no assurance that we will be able to obtain all of the licenses that we may need on attractive terms or at all, which could result in our having to reformulate or abandon this product candidate.In addition, Cedars-Sinai has previously granted another institution rights to the use of certain peptide materials that we may seek to incorporate into one or more of our cellular-based therapy product candidates. We may be

 

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required to obtain a license from that other institution if we wish to use these materials. If we are unable to obtain this license, we would be required to develop vaccine products without thepotential enhanced benefits that could be provided by these materials.

If we infringe or are alleged to have infringedanother party’s patent rights, we may be required to defend an infringement action or challenge the validity of the patents in court. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions toa successful conclusion. In addition, if we do not obtain a license, do not successfully defend an infringement action or are unable to have infringed patents declared invalid, we may:

 

  

incur substantial monetary damages;

 

  

encounter significant delays in marketing our current product candidates or any future product candidates;

 

  

be unable to conduct or participate in the manufacture, use or sale of product candidates or methods of treatment requiring licenses;

 

  

lose patent protection for our inventions and products; or

 

  

find our patents are unenforceable, invalid, or have a reduced scope of protection.

Parties making such claims may be able to obtain injunctive relief that could effectively block our ability to further develop orcommercialize our current product candidates or any future product candidates in the United States and abroad and could result in the award of substantial damages. Defense of any lawsuit or failure to obtain any such license could substantially harmus. Litigation, regardless of outcome, could result in substantial cost to and a diversion of efforts by us.

We will be dependent on ourkey personnel, and the loss of one or more of our key personnel would materially and adversely affect our business and prospects.

Except for our President and Chief Executive Officer and our Vice President – Product Development and Manufacturing, we do not have any full-time management personnel. We are dependent on ourofficers and directors for their scientific or managerial skills, including Dr. John Yu, our Chairman of the Board, and Dr. Manish Singh, our President and Chief Executive Officer. However, these individuals (with the exception ofDr. Singh and our Vice President – Product Development and Manufacturing) are associated with us on a part-time basis only. We do not currently maintain key man life insurance on Drs. Yu and Singh. The terms of the current employmentagreement for Dr. Singh and the agreement for Dr. Yu have expired and they have continued to serve as our President and Chief Executive Officer and Chief Scientific Officer, respectively, under the terms of the foregoing agreements pendingthe negotiation of new agreements. Although we anticipate concluding these new agreements in the near future, there can be no assurance that we will be successful in entering into these agreements on satisfactory terms or at all. Our employmentcontract with Dr. Singh and our agreement with Dr. Yu under which he serves as our Chief Scientific Officer permit them to terminate providing their services to us without cause. The loss of the services of either Dr. Singh orDr. Yu would materially and adversely affect our business.

As we retain additional full-time senior personnel, ouroverhead expenses for salaries and related items will increase substantially from current levels. Competition for such personnel is intense, and there is no assurance that we will be able to attract or retain qualified senior personnel and ourfailure to do so could have an adverse effect on our ability to implement our business plan.

 

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The market success of our current product candidates and any future product candidates will be dependentin part upon third-party reimbursement policies that have not yet been established for our product candidates.

Ourability to successfully commercialize and penetrate the market for our current product candidates and any future product candidates is likely to depend significantly on the availability of reimbursement for our lead product candidate or any other orfuture product candidates from third-party payers, such as governmental agencies, private insurers and private health plans. Even if we are successful in bringing a proposed product candidate to the market, these product candidates may not beconsidered cost-effective, and the amount reimbursed for our products may be insufficient to allow us to sell any of our products on a competitive basis. We cannot predict whether levels of reimbursement for our product candidates, if any, will behigh enough to allow the price of our product candidates to include a reasonable profit margin. Even with FDA approval, third-party payers may deny reimbursement if the payer determines that our particular product candidates are unnecessary,inappropriate or not cost effective. If patients are not entitled to receive reimbursements similar to reimbursements for competing products which currently are reimbursable, they may be unwilling to use our product candidates since they will haveto pay for the unreimbursed amounts. The reimbursement status of newly approved health care products is highly uncertain. If levels of reimbursement are decreased in the future, the demand for our lead proposed product candidate and any futureproduct candidates could diminish or our ability to sell our products on a profitable basis could be adversely affected.

Webelieve that the efforts of governments and third-party payors to contain or reduce the cost of healthcare will continue to affect the business and financial condition of pharmaceutical and biopharmaceutical companies. Comprehensive health carereform legislation that was enacted in 2010 could adversely affect our business and financial condition. Among other provisions, the legislation provides that a “biosimilar” product may be approved by the FDA on the basis of analyticaltests and certain clinical studies demonstrating that such product is highly similar to an existing, approved product and that switching between an existing product and the biosimilar product will not result in diminished safety or efficacy. Thisabbreviated regulatory approval process may result in increased competition if we are able to bring a biopharmaceutical product to market. The legislation also includes more stringent compliance programs for companies in various sectors of the lifesciences industry with which we may need to comply and enhanced penalties for non-compliance with the new health care regulations. Complying with new regulations may divert management resources, and inadvertent failure to comply with new regulationsmay result in penalties being imposed on us.

Some states and localities have established drug importation programs for theircitizens, and federal drug import legislation has been introduced in Congress. The Medicare Prescription Drug Plan legislation, which became law in December 2003, required the Secretary of Health and Human Services to promulgate regulations for drugreimportation from Canada into the United States under some circumstances, including when the drugs are sold at a lower price than in the United States. The Secretary, however, retained the discretion not to implement a drug reimportation plan if hefinds that the benefits do not outweigh the costs, and has so far declined to approve a reimportation plan. Proponents of drug reimportation may attempt to pass legislation that would directly allow reimportation under certain circumstances.Legislation or regulations allowing the reimportation of drugs, if enacted, could decrease the price we receive for any products that we may develop and adversely affect our future revenues and prospects for profitability.

A number of legislative and regulatory proposals to change the healthcare system in the United States and other major healthcare marketshave been proposed in recent years. These proposals have included prescription drug benefit legislation recently enacted in the United States and healthcare reform legislation recently enacted by certain states. Further federal and state legislativeand regulatory developments are possible, and we expect ongoing initiatives in the United States to increase pressure on drug pricing. Such reforms could have an adverse effect on anticipated revenues from any products that we may successfullydevelop.

 

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We may be subject to product liability and other claims that could have a material negative effect on ouroperations and on our financial condition.

The development and sale of medical products in general, and vaccines inparticular, expose us to the risk of significant damages from product liability and other claims. Product liability claims could delay or prevent completion of our clinical development programs. If we succeed in marketing our current lead productscandidate or any future product candidates, such claims could result in an FDA investigation of the safety and effectiveness of our products or our marketing programs, and potentially a recall of our products or more serious enforcement action, orlimitations on the indications for which they may be used, or suspension or withdrawal of approval. We plan to obtain and maintain product liability insurance for coverage of our clinical trial activities and obtained this coverage for the recentlycompleted and current clinical trials of our dendritic cell-based vaccine product candidate. There is no assurance that we will be able to secure such insurance in the amounts we are seeking or at all for any of the future trials for our currentproduct candidates or any future product candidates. We intend to obtain coverage for our products when they enter the marketplace (as well as requiring the manufacturers of our products to maintain insurance), but we do not know if insurance willbe available to us at acceptable costs or at all. The costs for many forms of liability insurance have risen substantially in recent years and the costs for insuring a vaccine type product may be higher than other pharmaceutical products, and suchcosts may continue to increase in the future, which could materially impact our costs for clinical or product liability insurance. If the cost is too high, we will have to self-insure, and we may have inadequate financial resources to pay the costsof any claims. A successful claim in excess of our product liability coverage could have a material adverse effect on our business, financial condition and results of operations.

We may encounter delays and difficulties in the development of technologies or operations of any other businesses we may acquire.

We may, from time to time, acquire technologies or businesses that are complimentary to our existing technologies or operations or thatwe otherwise believe offer an attractive opportunity for us in the future. We may encounter various types of unanticipated difficulties in connection with developing these technologies or operating these businesses; the risk of these occurringpotentially being greater if these technologies or businesses are not directly related to any existing technology of operations. Any such difficulties could have a material adverse effect on our financial performance and condition.

Risks Related to Our Securities

Our stock may be traded infrequently and in low volumes, so you may be unable to sell your shares at or near the quoted bid prices if you need to sell your shares.

The shares of our common stock may trade infrequently and in low volumes on the OTC Bulletin Board, meaning that the number of personsinterested in purchasing our common shares at or near bid prices at any given time may be relatively small or non-existent. This situation may be attributable to a number of factors, including the fact that we are a small early stage company whichis relatively unknown to stock analysts, stock brokers, institutional investors and others in the investment community who can generate or influence sales volume, and that even if we came to the attention of such institutionally oriented persons,they tend to be risk-averse in this environment and would be reluctant to follow an early stage company such as ours or purchase or recommend the purchase of our shares until such time as we became more seasoned and viable. As a consequence, theremay be periods of several days or more when trading activity in our shares is minimal or non-existent, as compared to a seasoned issuer which has a large and steady volume of trading activity that will generally support continuous sales without anadverse effect on share price. We cannot give you any assurance that a broader or more active public trading market for our common shares will develop or be sustained. Due to these conditions, we can give you no assurance that you will be able tosell your shares at or near bid prices or at all if you need money or otherwise desire to liquidate your shares. As a result, investors could lose all or part of their investment.

 

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You may have difficulty selling our shares because they are deemed “penny stocks.”

Since our common stock is not listed on a national securities exchange, if the trading price of our common stock remainsbelow $5.00 per share, trading in our common stock will be subject to the requirements of certain rules promulgated under the Exchange Act, which require additional disclosure by broker-dealers in connection with any trades involving a stock definedas a penny stock (generally, any non-national securities exchange equity security that has a market price of less than $5.00 per share, subject to certain exceptions). Such rules require the delivery, prior to any penny stock transaction, of adisclosure schedule explaining the penny stock market and the risks associated therewith and impose various sales practice requirements on broker-dealers who sell penny stocks to persons other than established customers and accredited investors(generally defined as an investor with a net worth in excess of $1,000,000 or annual income exceeding $200,000 individually or $300,000 together with a spouse). For these types of transactions, the broker-dealer must make a special suitabilitydetermination for the purchaser and have received the purchaser’s written consent to the transaction prior to the sale. The broker-dealer also must disclose the commissions payable to the broker-dealer, current bid and offer quotations for thepenny stock and, if the broker-dealer is the sole market-maker, the broker-dealer must disclose this fact and the broker-dealer’s presumed control over the market. Such information must be provided to the customer orally or in writing before orwith the written confirmation of trade sent to the customer. Monthly statements must be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny stocks. The additional burdensimposed upon broker-dealers by such requirements could discourage broker-dealers from effecting transactions in our common stock, which could severely limit the market liquidity of the common stock and the ability of holders of the common stock tosell their shares.

Our existing directors, executive officers and principal stockholders hold a substantial amount of our common stock andmay be able to prevent other stockholders from influencing significant corporate decisions.

As of March 1, 2011, ourdirectors and executive officers beneficially owned approximately 25% of our outstanding common stock. Dr. John Yu also currently is entitled to serve as a director and to designate two of our other directors. These stockholders, if they acttogether, and Dr. Yu, through his right to name three of our directors, may be able to direct the outcome of matters, including the election of our directors and other corporate actions such as:

 

  

our merger with or into another company;

 

  

a sale of substantially all of our assets; and

 

  

amendments to our certificate of incorporation.

The decisions of these stockholders may conflict with our interests or those of our other stockholders.

Potential conflicts of interest could arise for certain members of our management team in the performance of their services for us.

Dr. John Yu, our Chairman of the Board, and Dr. Keith Black, the Chairman of our Scientific Advisory Board, are full-timeemployees of Cedars-Sinai, which owns shares of our common stock and where we plan to conduct certain research and development work, including clinical trials of our vaccine product candidates. Potential conflicts of interest could arise as aresult, including for Dr. Yu and Dr. Black in performing services for us and for Cedars-Sinai, in establishing the terms under which Cedars-Sinai performs work for us, and in Cedars-Sinai conducting the research. Dr. Yu and otherscientists associated with Dr. Yu at Cedars-Sinai may perform research in the field of brain tumors that is sponsored by other third parties. We will not acquire any interest in the intellectual property generated by this research, includingseveral clinical trials with dendritic cell based vaccines that have been completed or are planned to be initiated. These studies may compete for patients to be enrolled in clinical trials with our current or future clinical trials.

 

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Substantial sales of our common stock could cause our common stock price to fall.

In addition to our shares of common stock covered by this prospectus, there are currently 23,505,856 outstanding shares of ourcommon stock and another 13,629,428 shares of our common stock issuable upon exercise of currently exercisable options or warrants that are eligible to be sold pursuant to Rule 144 or currently effective registration statements. The possibilitythat substantial amounts of our common stock may be sold in the public market may adversely affect prevailing market prices for our common stock and could impair our ability to raise capital through the sale of our equity securities.

Our securities are quoted on the OTC Bulletin Board, which may limit the liquidity and price of our securities more than if our securities were quotedor listed on or a national securities exchange.

Our securities are currently quoted on the OTC Bulletin Board, anNASD-sponsored and operated inter-dealer automated quotation system for equity securities not listed on a national securities exchange. Quotation of our securities on the OTC Bulletin Board may limit the liquidity and price of our securities morethan if our securities were quoted or listed on a national securities exchange. Some investors may perceive our securities to be less attractive because they are traded in the over-the-counter market. In addition, as an OTC Bulletin Board listedcompany, we do not attract the extensive analyst coverage that accompanies companies listed on a national securities exchange. Further, institutional and other investors may have investment guidelines that restrict or prohibit investing insecurities traded in the over-the-counter market. These factors may have an adverse impact on the trading and price of our securities.

Themarket price of our stock may be adversely affected by market volatility.

The market price of our common stock is likelyto be volatile and could fluctuate widely in response to many factors, including:

 

  

announcements of the results of clinical trials by us or our competitors;

 

  

developments with respect to patents or proprietary rights;

 

  

announcements of technological innovations by us or our competitors;

 

  

announcements of new products or new contracts by us or our competitors;

 

  

actual or anticipated variations in our operating results due to the level of development expenses and other factors;

 

  

changes in financial estimates by securities analysts and whether our earnings meet or exceed such estimates;

 

  

conditions and trends in the pharmaceutical and other industries;

 

  

new accounting standards;

 

  

general economic, political and market conditions and other factors; and

 

  

the occurrence of any of the risks described in this report.

FORWARD-LOOKING STATEMENTS

This prospectuscontains forward-looking statements, which reflect the views of our management with respect to future events and financial performance. These forward-looking statements are subject to a number of uncertainties and other factors that could causeactual results to differ materially from such statements.

 

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Forward-looking statements are identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,”“projects,” “targets” and similar expressions. Readers are cautioned not to place undue reliance on these forward-looking statements, which are based on the information available to management at this time and which speak only asof this date. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. For a discussion of some of the factors that may cause actual results to differmaterially from those suggested by the forward-looking statements, please read carefully the information under “Risk Factors” beginning on page 3.

The identification in this document of factors that may affect future performance and the accuracy of forward-looking statements is meant to be illustrative and by no means exhaustive. All forward-lookingstatements should be evaluated with the understanding of their inherent uncertainty. You may rely only on the information contained in this prospectus.

We have not authorized anyone to provide information different from that contained in this prospectus. Neither the delivery of this prospectus nor the sale of common stock means that information containedin this prospectus is correct after the date of this prospectus. This prospectus is not an offer to sell or solicitation of an offer to buy these securities in any circumstances under which the offer or solicitation is unlawful.

USE OF PROCEEDS

We will not receive any proceeds from the sale of the common stock by the selling securityholders pursuant to this prospectus. All proceeds from the sale of the shares will be for the account of theselling securityholders. We will, however, receive the proceeds from the exercise of the warrants held by the selling securityholders for the 2,818,689 shares underlying such warrants which are covered by this prospectus. If all of the warrants topurchase the 2,818,689 shares are exercised for cash at their current exercise price of $2.25 per share, the total amount of proceeds that we would receive is approximately $6,342,050. We would expect to use the proceeds from the exercise ofwarrants, if any, for general working capital purposes. We will pay the expenses of registration of these shares, including legal and accounting fees.

BUSINESS

Overview

ImmunoCellular Therapeutics, Ltd. is a development stage company that is seeking to develop and commercialize new therapeutics to fightcancer using the immune system. Our product candidate portfolio includes cellular immunotherapies targeting cancer and cancer stem cell antigens, peptide based immunotherapies targeting cancer stem cells, and monoclonal antibodies to diagnose andtreat several different cancers. We have completed a Phase I clinical trial of our dendritic cell based vaccine product candidate (ICT-107) to treat newly diagnosed glioblastoma multiforme (GBM) that was initiated in May 2007, and we initiated amulticenter Phase II clinical trial of this vaccine in January 2011. This product candidate may also be efficacious in the treatment of recurrent GBM, and we are planning to initiate a pilot trial of this vaccine for this indication in 2011. Anotherone of our vaccine product candidates is a peptide based off-the-shelf vaccine (ICT-121) to target multiple solid tumors which is undergoing preclinical development. This vaccine targets cancer stem cells, which are believed by many scientists to beroots of cancer, and may be applicable in multiple cancer indications. In addition, we have several monoclonal antibody product candidates targeting small cell lung cancer, pancreatic cancer, multiple myeloma and ovarian cancer. Through twoimportant acquisitions in the last five years, we are building capabilities to develop new cancer immunotherapeutic products harnessing mechanisms of immune system surveillance in the human body.

In November 2006, we acquired an exclusive, worldwide license from Cedars-Sinai Medical Center to certain technology for use ascellular-based therapies, including dendritic cell-based vaccines for neurological disorders that include brain tumors and neurodegenerative disorders and other cancers. This technology is

 

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covered by a number of pending U.S. and foreign patent applications. In June 2008, we licensed an additional technology from Cedars-Sinai to target cancer stem cells that may be applicable forbrain tumors as well as several other cancer indications.

In February 2008, we entered into an agreement with MolecularDiscoveries LLC, a New York limited liability company, covering our acquisition of certain monoclonal antibody related technology owned by Molecular Discoveries and completed the acquisition of the technology on that date. The technology acquiredunder the Molecular Discoveries agreement and now owned by us consists of (i) a platform technology referred to by Molecular Discoveries as DIAAD for the potentially rapid discovery of targets (antigens) and monoclonal antibodies for diagnosisand treatment of diverse human diseases and (ii) certain monoclonal antibody candidates for the potential detection and treatment of multiple myeloma, small cell lung, pancreatic and ovarian cancers. The monoclonal antibodies are covered byissued patents and pending patent applications in the fields of multiple myeloma, small cell lung and ovarian cancers.

We donot currently anticipate that we will derive any revenues from either product sales or licensing during the foreseeable future. We do not have any bank credit lines and have financed substantially all of our prior operations through the sale ofsecurities, including a private placement of our securities that we completed in February 2011 that generated $8,090,644 of proceeds for us (before commissions and offering expenses).

The estimated cost of completing the development of either of our current vaccine product candidates and of obtaining all requiredregulatory approvals to market either of those product candidates is substantially greater than the amount of funds we currently have available. We believe that our existing cash balances, together with potential proceeds from our preferred stockpurchase arrangement with Socius Capital Group, LLC, will be sufficient to fund our currently planned level of operations for at least the next twelve months. We will seek to obtain additional funds through various financing sources, includingpossible sales of our securities, and in the longer term through strategic alliances with other pharmaceutical or biopharmaceutical companies, but there can be no assurance that we will be able to obtain any additional funding from any potentialfinancing sources, or create any such alliances, or that the terms under which we would obtain any funding will be sufficient to fund our operations.

Company History

We filed our original Certificate of Incorporation withthe Secretary of State of Delaware on March 20, 1987 under the name Redwing Capital Corp. On June 16, 1989, we changed our name to Patco Industries, Ltd. and conducted an unrelated business under that name until 1994. On January 30,2006, we amended our Certificate of Incorporation to change our name to Optical Molecular Imaging, Inc. in connection with our merger on January 31, 2006 with Spectral Molecular Imaging, Inc. On November 2, 2006, we amended our Certificateof Incorporation to change our name to ImmunoCellular Therapeutics, Ltd. to reflect our disposition of our Spectral Molecular Imaging subsidiary and our acquisition of our cellular-based technology from Cedars-Sinai.

Our principal executive offices are located at 21900 Burbank Boulevard, 3rd Floor, Woodland Hills, California 91367, and our telephone number atthat address is (818) 992-2907.

 

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Technology and Proposed Products

Overview

The table below summarizes the status of our product candidates

 

Product candidate

  

Target Indication

  

Status

Active Immunotherapy:

 

    

ICT-107

(DC vaccine targeting cancer stem cells and cancer antigens)

 

  Newly Diagnosed Glioblastoma  Phase II ongoing

ICT-121

(off-the-shelf cancer stem cell vaccine)

 

  Glioblastoma, Pancreatic cancer and other solid tumor cancers  Pre-clinical

Monoclonal Antibodies:

 

    

ICT-109 (Monoclonal Antibody)

  

Lung and pancreatic and colon cancer therapeutic

 

  Pre-clinical

ICT-037 (Monoclonal Antibody)

  

Colon, ovarian, multiple myeloma therapeutic and diagnostic

 

  Pre-clinical

ICT-69 (Monoclonal Antibody)

  

Multiple myeloma and ovarian cancer

 

  Pre-clinical

ICT-Diagnostic-SCLC

  Diagnostic/Prognostic for small cell lung cancer  Pre-clinical

Cancer is caused by abnormalcells that grow in an uncontrolled manner. These cells proliferate and metastasize throughout the body causing tumors which can cause organ failure and death. The current treatments such as surgery, radiation and chemotherapy have limitedtherapeutic effects and significant undesirable side effects. Our approach is to harness the body’s immune system to provide therapeutics with the ability to fight cancer. There are two arms of the immune system that provide natural protectionto the body: the cellular immune system (T-cell based) and the humoral immune system (B-cell based), which uses antibodies to fight foreign invaders. Our strategy is to utilize both of these mechanisms in our product development programs. We believethat the synergy between the two types of immunity can be powerful. Elicitation of a cellular immune response has the potential of long-term protection against malignant diseases, while infusion of monoclonal antibodies (concentrated product of thehumoral response) has the capacity to confer an immediate shield against the disease. The latter is especially important in cases where the patient’s immune system is compromised due to toxic treatment of the disease and cannot mount anadequate response to the active vaccine. In some situations a combination of a passive vaccine (monoclonal antibodies) aimed at halting the dissemination of cancer cells through the blood followed by an active vaccine when the patient recuperatesmay constitute an effective synergistic approach.

Active Immunotherapy

One of our product strategies is the development of cell-based vaccine products that could bolster the body’s natural tendencythrough its immune system to defend it against malignant brain tumors. We have been developing two forms of these vaccines, one based on cancer stem cells and one based on dendritic cells.

The high rate of mortality of patients diagnosed with brain cancers and in particular with glioblastoma multiforme (the most lethal anddevastating form) is driving the scientific community to discover and develop

 

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improved treatments that could increase the survival time and enhance the quality of life of patients. Of the approximately 19,000 cases of malignant brain and spinal cord tumors that arediagnosed each year in the United States, there currently is no satisfactory treatment, and the two-year survival rates are only in the range of 26%. Neither surgery, radiation nor anti-cancer drugs, the standard treatment modalities, have shown todate any prospect of meaningful extension of patients’ lives. We and others in the medical research community believe that immunotherapy has the potential, in the not too distant future, to be teamed with other treatment modalities to become anintegral part of mainstream medical practice in the treatment of patients with brain tumors.

Dendritic Cell Vaccines

Dendritic cells (human derived cells responsible for antigen processing and presentation to the immune system) play a centralrole in the body’s immune response. They trigger the systems that help the body fight infection or foreign bodies, by initiating a T cell or T cell response to the infection or foreign body. The dendritic cells do this by recognizing,processing and presenting foreign antigens (substances that stimulate the production of antibodies and combine specifically with them) to the T cells, which then effectuate the immune response. The goal of a cell-based vaccine is to(i) make use of and enhance the dendritic cell’s ability to trigger the T cell response and (ii) to stimulate the dendritic cell to focus the T cell response to specifically target the cancer cells for destruction.

Even though dendritic cells can be very potent, they are usually not present in sufficient numbers to permit an adequatelypotent immune response to fight cancer. What is more, dendritic cells often do not react aggressively to malignant tumors; they do not treat the tumor as a foreign body that needs to be destroyed or neutralized. Dendritic cells are powerfulpotentiators of acquired immunity through an effective presentation of the cancer antigens to T cells which subsequently mediate the killing of the cancer cells. Thus, dendritic cells are critical facilitators of T cell response. Dendritic celltherapy generally involves harvesting dendritic cells from a patient, then culturing and processing them in a laboratory to produce more numerous and effective dendritic cells. In the laboratory, the dendritic cells are cultured with specificantigens that are on tumor cells to enable the dendritic cells to recognize cancer cells as targets for attack. When the newly cultured dendritic cells are injected back into the patient, they seek out remaining tumor cells and signal theT cells to destroy them.

Peptide Vaccines Targeting Cancer Stem Cells

Cancer stem cells are considered as a subset of cancerous cells which are responsible for the growth and re-growth of the primary andmetastatic tumors. Complete eradication of tumor masses requires elimination of these cells, which are resistant to standard chemotherapy and radiation therapy. There are a number of markers that have been identified on various cancer stem cellswhich could be exploited for targeting these cells. We are utilizing peptides in combination with an adjuvant that can elicit an immune response in the body by triggering T cells to identify and destroy these cancer stem cells. These peptides werespecifically designed to elicit a T cell response targeting CD133 positive cancer stem cells that have been identified in a number of cancer types, including gliomas, colon cancer and pancreatic cancer.

Antibody Immunotherapy

Another strategy for our product development is to harness the other arm of the immune system, which uses antibodies that can bind and neutralize any foreign antigen. These antibodies are produced by theB-lymphocytes (B-cells), and each antibody recognizes only one antigen. The antibodies we have acquired from Molecular Discoveries have been created to recognize certain antigens primarily expressed on the cancer cells and not expressed on thenormal cells, such that binding to those antigens can lead to death of the tumor cells. We also have acquired an antibody development platform called DIAAD from our technology acquisition from Molecular Discoveries, which may enable us to discoverand develop novel antigens and antibodies for cancer cells.

 

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ICT-107: Dendritic Cell-Based Vaccine Targeting Tumor Associated Antigens

Current treatment of glioblastoma multiforme and other brain cancers involves a combination of surgery, radiation treatment, andchemotherapy. A significant issue with chemotherapy is that even as the chemicals become more powerful and more specifically targeted at a tumor’s DNA, the tumor’s cells may “outmaneuver” the chemotherapy by mutating or otherwiserepulsing the attack. However, by combining chemotherapy with a cell-based immunotherapy treatment regimen, it appears that this could potentially enhance chemotherapy sensitivity and thereby improve patient treatment.

In a number of laboratory and clinical trials, dendritic cell immunotherapy has succeeded in eliciting a powerful immune response againstbrain tumor cells, but without achieving significant improvement in length of survival. Similarly, chemotherapy, even using agents specifically designed to attack the DNA of tumor cells and prevent their replication, becomes ineffective as the tumorcells develop drug resistance.

By combining chemotherapy and immunotherapy in a “two wave” approach, we believethat more promising results may be achievable. This would combine a first wave of a dendritic cell-based vaccine that is specifically formulated using highly immunogenic tumor antigens designed to destroy tumor cells and their ability to mutate,followed by a second wave of targeted chemotherapy targeted against the remaining cancer cells that have had their ability to mutate significantly impaired or destroyed by the vaccine.

Dr. Yu completed two clinical trials at Cedars-Sinai prior to his association with our company using dendritic cells loaded withtumor lysates derived from the patient’s cancer to generate an immune response against intracranial tumors. The results of these early studies preliminarily demonstrated the safety of dendritic cell vaccination as well as biological efficacy ingenerating specific anti-tumor T cell responses. Based upon some additional pre-clinical research, Dr. Yu and his Cedars-Sinai team have developed what they believe could be a new, improved dendritic cell-based therapeutic vaccine, ICT-107.

ICT-107 is a new generation dendritic cell-based therapeutic vaccine that consists of a number of specific tumor antigenswhich, when loaded onto the dendritic cells, are expected to stimulate the body’s T cells to target only these specific proteins on the patient’s tumor cells. This product candidate is an intradermal dendritic cell-based therapeuticvaccine that we plan to use with chemotherapy concomitantly or subsequent to conventional therapy in patients with first diagnosed or recurrent glioblastoma.

We have tested ICT-107 in a Phase I clinical trial at Cedars-Sinai in patients with glioblastoma. The trial enrolled 19 patients and the vaccine was well tolerated, with no significant adverse eventsreported. Of the 16 newly diagnosed GBM patients treated in this trial, 11 patients are still alive, with 3 patients surviving at least 3 years after the surgery that preceded their vaccine treatment. Of the 11 patients who are still alive, 3 of thepatients are completely free of the disease after 3 years, and an additional 3 of these patients are completely free of the disease after 2 years. The median progression free survival in the 16 newly diagnosed patients enrolled in the trial was 17months and 6 of these 16 patients continue to show no signs of tumor recurrence at the present time.

In January 2010, wereported the results of a study in which it was shown that certain specific antigens are highly expressed on cancer stem cells. This suggests that ICT-107, which targets those antigens, potentially may effectively target not only the cells that makeup the bulk of certain cancerous tumors, but also the cancer stem cells that are widely believed to give rise to them and to cause their recurrence.

In June 2010, ICT-107 was granted Orphan Drug status by the FDA, making this product candidate eligible, under certain circumstances, for marketing exclusivity and other potential benefits.

On September 1, 2010, we entered into a Master Services Agreement (the “MSA”) with Averion International Corp., a clinicalresearch organization (“Averion”). Under the MSA, Averion will provide us with clinical trial support services in connection with and over the course of our Phase II clinical trial forICT-

 

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107, our lead product candidate for the treatment of brain cancer. Under the MSA, Averion will oversee the enrollment of patients and execution of our Phase II trial. The MSA, which may beterminated by us at any time, provides for a limit of approximately $3.5 million on the fees that we will be obligated to pay Averion if all of the planned services are actually provided.

In January 2011, we entered into a sponsored research and vaccine production agreement with the University of Pennsylvania under whichthat institution, which has assisted us in optimizing the formulation of ICT-107 that we are using in our Phase II trial of that vaccine, will assist us in the GMP production of supplies of that vaccine for this trial.

ICT-121: Cancer Stem Cell Vaccine For Glioblastoma Multiforme

The laboratory at Cedars-Sinai Medical Center of Dr. John Yu, our Chairman of the Board and the Director of Surgical Neurooncology at the Maxine Dunitz Neurosurgical Institute at Cedars-Sinai, wasinstrumental in identifying the cancer stem cells in glioblastoma. The characterization of cancer stem cells from glioblastoma has provided an opportunity to study the etiology of this dreaded disease and to be engaged in the development of productcandidates that would be able to target the cancer stem cells which are believed to be responsible for the initiation and maintenance of glioblastoma. Dr. Yu and his team have identified several peptides that can elicit an immune responsetargeting CD133, a common marker present on most cancer stem cells. These peptides are specific to certain HLA markers in humans.

Our vaccine product candidate, ICT-121, is a peptide that can elicit an immune response in a HLA-A*0201 serotype patient population to target CD133 positive cancer stem cells in brain tumors and othercancers. HLA is the molecule by which protein segments are presented to the immune system by antigen presenting cells. HLA-A2 represents the most prevalent HLA Class I type in North America. The current treatment of glioblastoma and other braincancers involves a combination of surgery, radiation treatment and chemotherapy. One of the significant issues with this treatment is the recurrence of tumors after a few months of treatment, which may be due to cancer stem cells left intact asthese cells are resistant to chemotherapy as well as radiation therapy. By combining conventional treatment with a vaccine to target remaining cancer stem cells, one could potentially significantly delay or eliminate recurrence of these tumors.

We are currently conducting additional preclinical studies to support an IND filing that we are targeting for ICT-121 in2011. Subject to successfully obtaining the necessary preclinical data, we plan to initiate a Phase I clinical trial for this vaccine after the IND filing has been cleared by the FDA. This trial will be a multi-center clinical trial in bothrecurrent as well as newly diagnosed patients with clinical as well as immunological response as the end points. We plan to enroll 15-20 patients for this trial.

Monoclonal Antibodies Targeting Cancer

We acquired from MolecularDiscoveries several monoclonal antibodies that react with small cell lung cancer cells, bind to the molecular structure and kill those cells in vitro. The survival rate is significantly higher when the disease is still localized, but only 16% oflung cancers are diagnosed at this early stage according to the American Cancer Society. Thus, the creation of new screening, monitoring and diagnostic tests for early detection and disease follow-up of small cell lung cancer may save many lives andprolong the survival of patients afflicted with this devastating disease.

In collaboration with George Mason University, werecently completed a pilot study evaluating the cancer detection abilities of one of our monoclonal antibody product candidates, ICT-109. Data from this study demonstrated that ICT-109 had a statistically significant ability to discriminate betweencancerous and non-cancerous samples, suggesting the potential to detect pancreatic and lung cancer in plasma and serum study sets. The study used reverse phase micro array technology to determine serum and plasma expression levels of glycosylatedCEA, and was performed in collaboration with Dr. Emanuel Petricoin at George Mason University. Researchers at George Mason University investigated the ability of ICT-109 to detect pancreatic

 

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and lung cancer by binding specifically to glycosylated epitopes of CEA-CAM6 and CEA-CAM5, two common markers that are overly expressed in a majority of cancers. Glycosylated CEA is highlyexpressed in patients with pancreatic and lung cancers, and can be used to detect these cancers using a direct blood test. As CEA-CAM5 and CEA-CAM6 are also present on the normal tissue, any commercial product would require adding additional markersfor developing a test with higher sensitivity and specificity.

Small cell lung cancer is the most aggressive form of lungcancer tethered with cigarette smoking. Small cell lung cancer cases are estimated to constitute about 13% of all lung cancer cases. In the United States, the American Cancer Society estimated 210,000 new lung cancer cases, as well as 161,000deaths, occurred in 2008. Early diagnosis of small cell lung cancer is very difficult, and consequently, the vast majority of patients manifest an established cancer with metastasis at the time of diagnosis.

DIAAD utilizes immunological tolerization to accelerate the discovery of the molecular differences between diseased cells and theirnormal counterparts. The monoclonal antibodies produced by DIAAD provide the basis for the discovery and development of our potential diagnostic and therapeutic products.

DIAAD enhances the antibody response of laboratory animals to disease-specific antigens. Antibodies are proteins produced by the body’s immune system that target and selectively bind antigens foundon the surface of cancer cells or cells invaded by pathogens such as bacteria and viruses. There are billions of antibodies, each capable of recognizing and binding a different and specific antigen. Antibodies produced from a single B cell aretermed “monoclonal” and represent one unique protein sequence with a unique specificity and affinity.

Conventionalmethods of monoclonal antibody discovery involve immunizing a laboratory animal with diseased cells. Since the majority of the antigens expressed by the diseased cells are also present on normal cells, the vast majority of the antibodies producedalso bind to the normal cells. The discovery of antibodies that bind only to the diseased cell involves a lengthy screening process to remove antibodies reacting with normal tissues. Thus, the screen for such an antibody is often exhaustive and timeconsuming and entails testing thousands of antibodies for their ability to bind selectively to the diseased cell.

DIAADfocuses the immune response on the tumor antigens by first eliminating the immune response directed against antigens on the normal cells. This is done by a process immunologists call tolerization, which is followed by immunizing the tolerizedanimals with prostate cancer cells. This directs the immune response towards only those antigens that are present on the cancerous but not on the normal cells.

We have conducted limited development activities for our monoclonal antibody product candidates, ICT-37 and ICT-109, for the diagnosis and treatment of small cell lung cancer and pancreatic cancer. Weinitiated a collaboration with Antitope, Ltd (UK) to humanize these antibodies by using their proprietary technologies, which was completed in August 2009. In light of the potential need to access other technology to combine our antibodies withother cancer killing technologies and the significant projected pre-clinical development costs for these antibodies, we plan during 2011 to continue to seek partners or licensees to develop these product candidates.

We also have another antibody product candidate, ICT-69, which targets ovarian cancer and multiple myeloma. ICT-69 was designed using ourDIAAD (differential immunization for antigen and antibody discovery) technology with the purpose of targeting human multiple myeloma and ovarian cancer cells. In September 2009, we entered into a research and option license agreement with RocheGroup, a leading global pharmaceutical company, giving them an option to acquire a license to develop and commercialize ICT-69, our monoclonal antibody product candidate targeting multiple myeloma and ovarian cancer. In September 2010, the RocheGroup advised us that it had elected to not exercise this option to acquire a license to develop and commercialize ICT-69.

 

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These monoclonal antibody programs are at a pre-clinical stage of development and willrequire further development before an IND can be potentially filed for human testing. We expect our potential partners or licensees to do this development work.

Cedars-Sinai Agreements

In November 2006, we entered into a licenseagreement with Cedars-Sinai under which we acquired an exclusive, worldwide license to our technology for use as cellular therapies, including dendritic cell-based vaccines for neurological disorders that include brain tumors and neurodegenerativedisorders and other cancers. This technology is covered by a number of pending U.S. and foreign patent applications, and the term of the license will be until the last to expire of any patents that are issued covering this technology.

As an upfront licensing fee, we issued Cedars-Sinai 694,000 shares of our common stock and paid Cedars-Sinai $62,000. Additionalspecified milestone payments will be required to be paid by us to Cedars-Sinai with respect to our first product when we initiate patient enrollment in our first Phase III clinical trial and when we receive FDA marketing approval for our firstproduct. If both of these milestones are met, the required milestone payments will total $1,250,000.

In June 2008, welicensed through an amendment to our original license agreement with Cedars-Sinai an additional cancer stem cell vaccine technology from Cedars-Sinai for which we paid 100,000 shares of our common stock.

We have agreed to pay Cedars-Sinai specified percentages of our gross revenues from sales of products (a percentage in the mid-singledigits) and of all of our sublicensing income based on the licensed technology, subject to a reduction if we must make any payments to any third party whose proprietary rights would be infringed by sale of the products. To maintain our rights to thelicensed technology, we must meet certain development and funding milestones.

In September 2010, we entered into a sponsoredresearch agreement with Cedars-Sinai under which Cedars-Sinai will provide services to us in developing standard operating procedures for dendritic cell vaccine preparations at a total cost of up to $446,000.

Molecular Discoveries Agreement

In February 2008, we entered into an agreement with Molecular Discoveries covering our acquisition of certain monoclonal antibody related technology owned by Molecular Discoveries and completed theacquisition of the technology on that date. The Molecular Discoveries Agreement also was acknowledged and agreed to by Dr. Cohava Gelber, an inventor of the technology acquired by us under this agreement and an equity owner of MolecularDiscoveries. We have retained Dr. Gelber as a consultant to assist us in developing the acquired technology.

Thetechnology acquired under the Molecular Discoveries agreement and now owned by us consists of (i) a platform technology referred to by Molecular Discoveries as DIAAD for the potentially rapid discovery of monoclonal antibodies to detect andtreat cancer and other chronic diseases and (ii) certain monoclonal antibody candidates for the potential detection and treatment of multiple myeloma, small cell lung, pancreatic and ovarian cancers. The monoclonal antibodies are covered byissued patents and pending patent applications in the fields of multiple myeloma, small cell lung and ovarian cancers. The consideration that we paid for the acquired technology consisted of (i) the issuance of 800,000 shares of our commonstock to Molecular Discoveries and (ii) our reimbursement to Molecular Discoveries or its managing member of $250,000 of previously incurred patent expenses.

 

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Competition

The pharmaceutical and biopharmaceutical industry is characterized by intense competition and rapid and significant technological changes and advancements. Many companies, research institutions anduniversities are doing research and development work in a number of areas similar to those that we focus on that could lead to the development of new products which could compete with and be superior to our product candidates.

Most of the companies with which we compete have substantially greater financial, technical, manufacturing, marketing, distribution andother resources than those of ours. A number of these companies may have or may develop technologies for developing products for treating various diseases that could prove to be superior to ours. We expect technological developments in thepharmaceutical and biopharmaceutical and related fields to occur at a rapid rate, and we believe competition will intensify as advances in these fields are made. Accordingly, we will be required to continue to devote substantial resources andefforts to research and development activities in order to potentially achieve and maintain a competitive position in this field. Products that we develop may become obsolete before we are able to market them or to recover all or any portion of ourresearch and development expenses. We will be competing with respect to our products with companies that have significantly more experience in undertaking preclinical testing and human clinical trials with new or improved therapeutic products andobtaining regulatory approvals of such products. A number of these companies already market and may be in advanced phases of clinical testing of various drugs that may compete with our lead product candidate or any future product candidates. Ourcompetitors may develop or commercialize products more rapidly than we do or with significant advantages over any products we develop. Our competitors may therefore be more successful in commercializing their products than we are, which couldadversely affect our competitive position and business.

In addition to larger pharmaceutical or biopharmaceutical companiesthat may develop different competing technologies or technologies within the stem cell field, we will be competing with a number of smaller biotechnology companies that are focused on cellular therapy technologies, which may include among othersDendreon, Northwest Biotherapeutics, Antigenics, Celldex Therapeutics, NeuralStem, Geron, NeuroNova, ReNeuron, Stemcells, Inc., Advanced Cell Technology and Osiris Therapeutics. Dendreon has received FDA marketing approval for a prostrate cancervaccine utilizing dendritic cells, Northwest Biotherapeutics is developing a dendritic cell-based vaccine treating brain tumors, and Celldex Therapeutics has recently completed a Phase II clinical trial to treat glioblastoma with their cancervaccines, and other companies may also be developing vaccines of this type.

A number of monoclonal antibody productscurrently are being marketed for the treatment of cancer, including Rituxan®, Herceptin®, Compath®, Avastin®, Erbitux®, Vectibix®, Zevatin®, and Bexxar®, and numerous other monoclonal antibody based products are underdevelopment for the treatment of cancer. In the monoclonal antibody space, we will be directly competing against a number of other well-established pharmaceutical and biotech companies such as Genentech, Seattle Genetics, Immunomedica, Medarex,Immunogen and others. Several of these companies are also targeting lung, pancreatic and colon cancer.

Colleges,universities, governmental agencies and other public and private research organizations are becoming more active in seeking patent protection and licensing arrangements to collect royalties for use of technologies that they have developed, some ofwhich may be directly competitive with our lead product candidate or any future product candidates. The governments of a number of foreign countries are aggressively investing in cellular therapy research and promoting such research by public andprivate institutions within those countries. These domestic and foreign institutions and governmental agencies, along with pharmaceutical and specialized biotechnology companies, can be expected to compete with us in recruiting qualified scientificpersonnel.

 

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Our competitive position will be significantly impacted by the following factors, amongothers:

 

  

our ability to obtain FDA marketing approval for our product candidates on a timely basis

 

  

the level of acceptance of our products by physicians, compared to those of competing products or therapies

 

  

our ability to have our products manufactured on a commercial scale

 

  

the effectiveness of sales and marketing efforts on behalf of our products

 

  

our ability to meet demand for our products

 

  

our ability to secure insurance reimbursement for our products candidates

 

  

the price of our products relative to competing products or therapies

 

  

our ability to recruit and retain appropriate management and scientific personnel

 

  

our ability to develop a commercial scale research and development, manufacturing and marketing infrastructure either on our own or with one or morefuture strategic partners.

Intellectual Property

Our dendritic cell based vaccine and cancer stem cell vaccine product candidates are currently covered by seven patent applications thathave been filed in the United States and by patent applications that have been filed in certain foreign countries.

Inaddition, we have acquired exclusive worldwide ownership rights to eight granted U.S. and ten other patents for various European and Asian territories as well as several U.S. and foreign patent applications through our acquisition of the monoclonalantibody related technology from Molecular Discoveries. The issued patents relate to monoclonal antibodies targeting various cancers, including human myeloma, ovarian cancer and small cell lung cancer and have expiration dates ranging from 2019 to2023.

Employees

We have three full-time employees, including our President and Chief Executive Officer and our Vice-President – Product Development and Manufacturing. Our Chairman of the Board and Chief FinancialOfficer are part-time employees. In addition, we have a number of consulting agreements for clinical development, regulatory affairs, investor relations and business development.

Government Regulation

The United States and other developed countriesextensively regulate the preclinical and clinical testing, manufacturing, labeling, storage, record-keeping, advertising, promotion, export, marketing and distribution of drugs and biologic products. The United States Food and Drug Administration,under the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act and other federal statutes and regulations, regulates pharmaceutical and biologic products.

To obtain approval of our product candidates from the FDA, we must, among other requirements, submit data supporting safety and efficacy for the intended indication as well as detailed information on themanufacture and composition of the product candidate. In most cases, this will require extensive laboratory tests and preclinical and clinical trials. The collection of these data, as well as the preparation of applications for review by the FDAinvolve significant time and expense. The FDA also may require post-marketing testing to monitor the safety and efficacy of approved products or place conditions on any approvals that could

 

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restrict the therapeutic claims and commercial applications of these products. Regulatory authorities may withdraw product approvals if we fail to comply with regulatory standards or if weencounter problems at any time following initial marketing of our products.

The first stage of the FDA approval process for anew biologic or drug involves completion of preclinical studies and the submission of the results of these studies to the FDA. This data, together with proposed clinical protocols, manufacturing information, analytical data and other informationsubmitted to the FDA, in an investigational new drug application (“IND”), must become effective before human clinical trials may commence. Preclinical studies generally involve FDA regulated laboratory evaluation of product characteristicsand animal studies to assess the efficacy and safety of the product candidate.

After the IND becomes effective, a company maycommence human clinical trials. These are typically conducted in three sequential phases, but the phases may overlap. Phase I trials consist of testing of the product candidate in a small number of patients or healthy volunteers, primarily forsafety at one or more doses. Phase I trials in cancer are often conducted with patients who are not healthy and who have end-stage or metastatic cancer. Phase II trials, in addition to safety, evaluate the efficacy of the product candidate in apatient population somewhat larger than Phase I trials. Phase III trials typically involve additional testing for safety and clinical efficacy in an expanded population at multiple test sites. A company must submit to the FDA a clinical protocol,accompanied by the approval of the Institutional Review Boards at the institutions participating in the trials, prior to commencement of each clinical trial.

To obtain FDA marketing authorization, a company must submit to the FDA the results of the preclinical and clinical testing, together with, among other things, detailed information on the manufacture andcomposition of the product candidate, in the form of a new drug application (“NDA”) or, in the case of a biologic, like dendritic cell-based vaccines for neurological disorders, a biologics license application (“BLA”).

The amount of time taken by the FDA for approval of an NDA or BLA will depend upon a number of factors, including whether theproduct candidate has received priority review, the quality of the submission and studies presented, the potential contribution that the compound will make in improving the treatment of the disease in question, and the workload at the FDA. The FDAhas committed to reviewing standard BLAs in 10 months and priority BLAs in six months, but the actual time it takes to review any BLA that we may file could be substantially longer.

The FDA may, during its review of an NDA or BLA, ask for additional test data that may require the conduct of additional clinical trials.If the FDA does ultimately approve the product candidate for marketing, it may require post-marketing testing to monitor the safety and effectiveness of the product. The FDA also may in some circumstances impose restrictions on the use of theproduct, which may be difficult and expensive to administer and may require prior approval of promotional materials.

The FDAmay, in some cases, confer upon an investigational product the status of a fast track product. A fast track product is defined as a new drug or biologic intended for the treatment of a serious or life-threatening condition that demonstrates thepotential to address unmet medical needs for this condition. The FDA can base approval of an NDA or BLA for a fast track product on an effect on a surrogate endpoint, or on another endpoint that is reasonably likely to predict clinical benefit. If apreliminary review of clinical data suggests that a fast track product may be effective, the FDA may initiate review of entire sections of a marketing application for a fast track product before the sponsor completes the application.

We will also be subject to a variety of regulations governing clinical trials and sales of our products outside the United States.Whether or not FDA approval has been obtained, approval of a product candidate by the comparable regulatory authorities of foreign countries and regions must be obtained prior to the commencement of marketing the product in those countries. Theapproval process varies from one regulatory authority to another and the time may be longer or shorter than that required for FDA approval. In the European Union, Canada and Australia, regulatory requirements and approval processes are similar, inprinciple, to those in the United States.

 

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Before approving a BLA, the FDA will inspect the facilities at which the product ismanufactured and will not approve the product unless the manufacturing facilities are in compliance with the FDA’s cGMP, which are regulations that govern the manufacture, holding and distribution of a product. Manufacturers of biologics alsomust comply with the FDA’s general biological product standards. Following approval, the FDA periodically inspects drug and biologic manufacturing facilities to ensure continued compliance with the good manufacturing practices regulations. Wemust ensure that any third-party manufacturers continue to comply with those requirements. Failure to comply with these requirements subjects the manufacturer to possible legal or regulatory action, such as suspension of manufacturing or recall orseizure of product. Adverse patient experiences with the product must be reported to the FDA and could result in the imposition of marketing restrictions through labeling changes or market removal. Product approvals may be withdrawn if compliancewith regulatory requirements is not maintained or if problems concerning safety or efficacy of the product occur following approval.

The labeling, advertising, promotion, marketing and distribution of a drug or biologic product also must be in compliance with FDA and Federal Trade Commission, requirements, which include, among others,standards and regulations for off-label promotion, industry sponsored scientific and educational activities, promotional activities involving the internet, and direct-to-consumer advertising. We also will be subject to a variety of federal, stateand local regulations relating to the use, handling, storage and disposal of hazardous materials, including chemicals and radioactive and biological materials. In addition, we will be subject to various laws and regulations governing laboratorypractices and the experimental use of animals. In each of these areas, as above, the FDA has broad regulatory and enforcement powers, including the ability to levy fines and civil penalties, suspend or delay issuance of product approvals, seize orrecall products, and deny or withdraw approvals.

We also will be subject to federal regulation by the Occupational Safety andHealth Administration and the Environmental Protection Agency and to regulation under the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other federal and state regulatory statutes, and may in the future be subject toother federal, state or local regulations.

Research and Development

Research and development expenditures for the years ended December 31, 2009 and December 31, 2010 were $962,526 and $2,292,630,respectively.

Property

We currently maintain our corporate office in Woodland Hills, California under a month-to-month lease at a monthly rental rate of $3,493. We do not own or lease any other real property.

Legal Proceedings

Weare not currently a party to any legal proceedings. From time to time we may be involved in legal claims or proceedings that arise out of the ordinary course of business.

 

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MARKET PRICE OF AND DIVIDENDS ON COMMON EQUITY

AND RELATED STOCKHOLDER MATTERS

Market Information

Our common stock has been traded on the OTC BulletinBoard over-the-counter market since December 7, 2006, under the symbol “IMUC.” The following price information reflects inter-dealer prices, without retail mark-up, mark-down or commission and may not represent actual transactions:

 

Quarter Ended

  High   Low 

March 31, 2009

   0.35     0.15  

June 30, 2009

   0.59     0.22  

September 30, 2009

   1.38     0.28  

December 31, 2009

   1.22     0.61  

March 31, 2010

   1.10     0.82  

June 30, 2010

   2.44     0.97  

September 30, 2010

   1.18     0.84  

December 31, 2010

   1.58     0.87  

March 31, 2011

   2.55     1.29  

Stockholders

As of March 1, 2011, there were approximately 259 holders of record of our common stock, not including any persons who hold theirstock in “street name.”

Dividend Policy

We have not paid any dividends on our common stock to date and do not anticipate that we will pay dividends in the foreseeable future. Any payment of cash dividends on our common stock in the future willbe dependent upon the amount of funds legally available, our earnings, if any, our financial condition, our anticipated capital requirements and other factors that the Board of Directors may think are relevant. However, we currently intend for theforeseeable future to follow a policy of retaining all of our earnings, if any, to finance the development and expansion of our business and, therefore, do not expect to pay any dividends on our common stock in the foreseeable future.

Securities Authorized for Issuance Under Equity Compensation Plans

The following table summarizes, as of December 31, 2010, (i) the number of shares of our common stock that are issuable under our equity compensation plans upon the exercise of outstandingoptions, warrants and other rights, (ii) the weighted-average exercise price of such options, warrants and rights, and (iii) the number of securities remaining available for future issuance under our equity compensation plans.

 

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Plan Category

  Numberof
securities to be
issued upon
exercise of
outstanding options,
warrants and rights
   Weighted-average
exercise priceof
outstanding options,
warrants and rights
   Number of securities
remaining available for
future issuanceunder
equity compensation
plans (excluding
securities reflectedin
column (a))
 
   (a)   (b)   (c) 

Equity compensation plans approved by stockholders

   9,764,076    $0.91     1,541,772  

Equity compensation plans not approved by stockholders

   1,400,000    $1.10     —    
               

Total

   11,164,076    $0.94     1,541,772  

Our stockholdersapproved our Equity Plan. The only awards that are outstanding under that plan as of March 1, 2010 are options to acquire 2,978,671 shares of our common stock and restricted stock totaling 69,231 shares. In September 2008 the shareholdersincreased the authorized number of shares of our common stock available to be issued under our Equity Plan from 1,500,000 shares to 3,400,000 shares. In March 2010, our Board approved an increase in the number of shares of our common stock availableto be issued under our Equity Plan from 3,400,000 shares to 6,000,000 shares, which was approved by our shareholders in September 2010.

In January 2007, we granted to Dr. Keith L. Black a fully-vested, ten-year option to purchase 1,500,000 shares of our common stock at an exercise price of $1.10 per share in consideration for hisagreeing to serve as the Chairman of our Scientific Advisory Board. Dr. Black has exercised 100,000 shares of this option.

In November 2006, we granted to Dr. John Yu (1) an option to purchase 150,000 shares of our common stock in consideration forhis relinquishment of his royalty interest in the cellular-based therapy technology that we licensed and (2) an option to purchase 5,783,424 shares of our common stock in consideration of his agreeing to serve as our Chief Scientific Officerfor a one-year term. Both options have an exercise price of $1.00 per share, a term of ten years and were fully vested upon grant. In November 2006, our stockholders approved these option grants to Dr. Yu.

In November 2006, we granted to Technomedics Management & Systems, Inc. an option to purchase 300,000 shares of our common stockfor a term of seven years at an exercise price of $1.00 per share in consideration for Dr. Mosk agreeing to serve as our Non-Executive Chairman of the Board on a part-time basis for one year. Upon grant, 150,000 shares of the option vested,with the balance of the shares to vest in four equal quarterly installments following the date of grant. Dr. Mosk voluntarily resigned as our Non-Executive Chairman of the Board in January 2007 and resigned as a director on March 19, 2008.The balance of Technomedics’ 150,000 unvested option shares were cancelled as a result of Dr. Mosk’s voluntary resignation: The Technomedics’ option covering the remaining 150,000 vested option shares expired unexercised onMarch 18, 2010.

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

You should read the following information together with our financial statements and notes thereto that are included in this prospectus. This discussion contains forward-looking statements that involverisks, uncertainties, and assumptions. Actual results may differ materially from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to, those presented under “Risk Factors” andelsewhere in this prospectus.

Overview

On January 31, 2006, we completed a merger pursuant to which Spectral Molecular Imaging, Inc. became our wholly owned subsidiary. At the time of the merger, we had virtually no assets or liabilities,and we had not conducted any business operations for several years. In connection with the merger, we changed our name from Patco Industries, Ltd. to Optical Molecular Imaging, Inc. and replaced our officers and directors with those of SpectralMolecular Imaging. Although we acquired Spectral Molecular Imaging in the merger, for accounting purposes the merger was treated as a reverse merger since the stockholders of Spectral Molecular Imaging acquired a majority of our outstanding sharesof common stock and the directors and executive officers of Spectral Molecular Imaging became our directors and executive officers. Accordingly, our financial statements contained in this Annual Report and the description of our results ofoperations and financial condition reflect the operations of Spectral Molecular Imaging.

In May 2006, we decided to suspendour research and development activities on Spectral Molecular Imaging’s spectral imaging technology, and on September 11, 2006, we sold all of the outstanding capital stock of Spectral Molecular Imaging to Dr. Daniel Farkas, aco-founder of Spectral Molecular Imaging and inventor of its technology.

In November 2006, we acquired an exclusive,worldwide license from Cedars-Sinai Medical Center for certain cellular-based therapy technology that we are developing for the potential treatment of brain tumors and other forms of cancer and neurodegenerative disorders. We recently completed aPhase I clinical trial of a vaccine product candidate for the treatment of glioblastoma multiforme based on this technology.

In February 2008, we acquired certain monoclonal antibody related technology owned by Molecular Discoveries LLC. This technology consistsof (1) a platform technology referred to by Molecular Discoveries as DIAAD for the potentially rapid discovery of targets (antigens) and monoclonal antibodies for diagnosis and treatment of diverse human diseases and (2) certain monoclonalantibody candidates for the potential detection and treatment of multiple myeloma, small cell lung, pancreatic and ovarian cancers.

Planof Operation

We are a development stage company that is seeking to develop and commercialize new therapeutics to fightcancer using the immune system.

Since our company’s inception on February 25, 2004, we have been primarily engagedin the acquisition of certain intellectual property, together with the recent clinical testing activities for one of our vaccine product candidates, and have not generated any recurring revenues. As a result, we have incurred operating losses and,as of December 31, 2010, we had an accumulated deficit of $22,953,788. We expect to incur significant research, development and administrative expenses before any of our products can be launched and recurring revenues, if ever, are generated.

For additional information about our plan of business operation, see the “Business” section of this prospectus.

 

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Critical Accounting Policies

Management’s discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accountingprinciples generally accepted in the United States. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and relateddisclosure of contingent assets and liabilities. On an ongoing basis, management evaluates its estimates, including those related to impairment of long-lived assets, including finite lived intangible assets, accrued liabilities and certain expenses.We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilitiesthat are not readily apparent from other sources. Actual results may differ materially from these estimates under different assumptions or conditions.

Our significant accounting policies are summarized in Note 2 of our financial statements for the period from February 25, 2004 to December 31, 2010. We believe the following criticalaccounting policies affect our more significant judgments and estimates used in the preparation of our financial statements:

Development Stage Enterprise

We are a development stage enterprise as defined by FASB ASC Topic 915, “Accounting and Reporting by Development Stage Enterprises.” We are devoting substantially all of our present effortsto research and development. All losses accumulated since inception are considered as part of our development stage activities.

Research and Development Costs

Although we believe that our research and development activities and underlying technologies have continuing value, the amount of future benefits to be derived from them is uncertain. Research anddevelopment costs are therefore expensed as incurred rather than capitalized. During the year ended December 31, 2009 and December 31, 2010, we recorded an expense of $962,526 and $2,292,630, respectively, related to research anddevelopment activities.

Stock-Based Compensation

Stock-based compensation expense is estimated as of the grant date based on the fair value of the award and is recognized as expense overthe requisite service period, which generally equals the vesting period, based on the number of awards that are expected to vest. Estimating the fair value for stock options requires judgment, including the expected term of our stock options,volatility of our stock, expected dividends, risk-free interest rates over the expected term of the options and the expected forfeiture rate. In connection with our performance based programs, we make assumptions principally related to the number ofawards that are expected to vest after assessing the probability that certain performance criteria will be met.

Results of Operations

For the Twelve Months Ended December 31, 2009 and 2010

Revenues

We had $300,000 in revenues during the period for the twelve months ended December 31, 2009 related to a license fee payment wereceived under a research and license option agreement regarding our ICT-69 antibody product candidate with the Roche Group and no revenues during the period for the twelve months ended December 31, 2010. We do not expect to generate anyadditional operating revenues during 2011.

 

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Expenses

General and administrative expenses for the twelve months ended December 31, 2009 and for the twelve months ended December 31, 2010 were $1,677,421 and $2,035,526, respectively. During 2009 and2010, the Company accrued $84,667 and $158,750 in bonuses that are contingent on reaching certain clinical development milestones. Research and development expenses for the twelve months ended December 31, 2009 and for the twelve months endedDecember 31, 2010 were $962,526 and $2,292,630, respectively. We had $311,700 of non-cash expense for the twelve months ended December 31, 2009, consisting of $308,303 in stock based compensation and $3,397 in depreciation expense. We had$1,829,724 of non-cash expense for the twelve months ended December 31, 2010, including $1,018,238 in change in warrant liability expense, $807,853 in stock based compensation and $3,633 in depreciation expense. On November 10, 2010, theCompany received a grant under the Patent Protection and Affordable Care Act of 2010. The grant, which totaled $244,479, will be used to fund ongoing projects, including the continued development of ICT-107 and was recorded as an offset to researchand development costs for fiscal year ended December 31, 2010.

We expect the amount of our general and administrativecash expenses in 2011 to be higher than those cash expenses incurred in 2010, primarily due to increased employee compensation and costs associated with our phase II clinic trial. We estimate that the cost of our research and development work to beapproximately $5,000,000 in 2011, and we may incur significant additional research and development expenses should we expand our research and development work on additional potential applications for our existing technologies or should we acquireadditional technologies from one or more third parties.

Loss

We incurred a net loss of $2,626,205 for the twelve months ended December 31, 2009 and a net loss of $6,150,142 for the twelve monthsended December 31, 2010.

For the Twelve Months Ended December 31, 2008 and 2009

Revenues

We had no revenues during the period for the twelve months ended December 31, 2008 and $300,000 in revenues during the period for thetwelve months ended December 31, 2009 related to a license fee payment we received under a research and license option agreement regarding our ICT-69 antibody product candidate with the Roche Group. We do not expect to generate any additionaloperating revenues during 2010.

Expenses

General and administrative expenses for the twelve months ended December 31, 2008 and for the twelve months ended December 31, 2009 were $1,366,146 and $1,677,421, respectively. During 2008 and2009, the Company accrued $34,952 and $84,667 in bonuses that are contingent on reaching certain clinical development milestones. Research and development expenses for the twelve months ended December 31, 2008 and for the twelve months endedDecember 31, 2009 were $1,296,772 and $962,526, respectively. We had $1,004,432 of non-cash expense for the twelve months ended December 31, 2008, consisting of $513,357 in stock based compensation, $489,000 paid in common stock for inprocess research and development and $2,075 in depreciation expense. We had $311,700 of non-cash expense for the twelve months ended December 31, 2009, including $308,303 in stock based compensation and $3,397 in depreciation expense.

We expect the amount of our general and administrative cash expenses in 2010 to be higher than those cash expenses incurredin 2009, primarily due to increased employee compensation and costs associated with financing and investor relations activities. We estimate that the cost of our research and development work to be approximately $3,000,000 in 2010, and we may incursignificant additional research and development expenses should we expand our research and development work on additional potential applications for our existing technologies or should we acquire additional technologies from one or more thirdparties.

 

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Loss

We incurred a net loss of $3,059,730 for the twelve months ended December 31, 2008 and a net loss of $2,626,205 for the twelve months ended December 31, 2009.

Liquidity and Capital Resources

As of December 31, 2010, we had working capital of $4,896,360, compared to working capital of $1,053,438 as of December 31, 2009.

The estimated cost of completing the development of either of our current vaccine product candidates and of obtaining all requiredregulatory approvals to market either of those product candidates is substantially greater than the amount of funds we currently have available. However, we believe that our existing cash balances, together with the $8 million in proceeds, beforeoffering costs, from our February 2011 private placement and potential proceeds under our preferred stock purchase arrangement with Socius Capital Group, LLC, will be sufficient to fund our currently planned level of operations through at least thethird quarter of 2012, although there is no assurance that such proceeds will be sufficient for this purpose.

We do not haveany bank credit lines. In February 2011, we completed an $8,090,644 private placement, before commissions and costs, of 5,219,768 units at a price of $1.55 per unit, with each unit consisting of one share of our common stock and a warrant topurchase 0.5 of a share of our common stock at an exercise price of $2.25 per share. We may also in the future seek to obtain funding through strategic alliances with larger pharmaceutical or biomedical companies. In December 2009, we entered intoan agreement with Socius Capital under which Socius Capital has agreed to purchase our preferred stock from us from time to time with an aggregate of up to $6 million remaining. However, Socius Capital’s obligation to purchase shares ofour preferred stock is subject to our satisfying certain conditions at that time. There is no assurance that we will be able to satisfy those conditions if we wish to sell shares of our preferred stock to Socius Capital or that Socius Capital willhave ability to complete these purchases. We cannot be sure that we will be able to obtain any additional funding from either financings or alliances, or that the terms under which we may be able to obtain such funding will be beneficial to us. Ifwe are unsuccessful or only partly successful in our efforts to secure additional financing, we may find it necessary to suspend or terminate some or all of our product development and other activities.

As of December 31, 2010, we had no long-term debt obligations, no capital lease obligations, no material purchase obligations orother similar long-term liabilities. In addition, we have no financial guarantees, debt or lease agreements or other arrangements that could trigger a requirement for an early payment or that could change the value of our assets, and we do notengage in trading activities involving non-exchange traded contracts.

Cash Flows

For the Twelve Months Ended December 31, 2009 and 2010

We used $4,253,560 of cash in our operations for the twelve months ended December 31, 2010, compared to $2,151,781 for the twelvemonths ended December 31, 2009, as the non-cash portion of our net loss for the 2010 period was $1,829,724 and the non-cash portion of our net loss for the 2009 period was $311,700.

We provided $1,065,331 of cash from our investing activities for the twelve months ended December 31, 2010, consisting of $1,075,903in sales of certificates of deposit offset by $10,572 in purchases of equipment and $1,923,284 of cash in our investing activities for the twelve months ended December 31, 2009, consisting of $1,924,097 in sales of certificates of depositoffset by $813 in purchases of equipment.

 

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We received $8,176,652 of cash from financing activities for the twelve months endedDecember 31, 2010, consisting of $26,500 from the exercise of stock options, $3,779,158 from sales of preferred stock and $4,370,994 from the sale of common stock and $474,560 of cash from financing activities for the twelve months endedDecember 31, 2009, consisting of $11,812 from the exercise of stock options and $462,748 from the exercise of warrants.

For the Twelve Months Ended December 31, 2008 and 2009

We used $2,151,781 of cash in our operations for the twelve months ended December 31, 2009, compared to $1,945,447 for the twelvemonths ended December 31, 2008, as the non-cash portion of our net loss for the 2009 period was $311,700 and the non-cash portion of our net loss for the 2008 period was $1,004,432.

We provided $1,923,284 of cash from our investing activities for the twelve months ended December 31, 2009, consisting of $1,924,097in sales of certificates of deposit offset by $813 in purchases of equipment and $3,010,087 of cash in our investing activities for the twelve months ended December 31, 2008, consisting of $3,000,000 in purchases of certificates of deposit and$10,087 in purchases of equipment.

We received $474,560 of cash from financing activities for the twelve months endedDecember 31, 2009, consisting of $11,812 from the exercise of stock options and $462,748 from the exercise of warrants and no cash from financing activities for the twelve months ended December 31, 2008.

DIRECTORS, EXECUTIVE OFFICERS,

PROMOTERS AND CONTROL PERSONS

Executive Officers and Directors

The following table sets forth the name, age and position held by each of our executive officers and directors. Directors are elected fora period of one year and thereafter serve until the next annual meeting at which their successors are duly elected by the stockholders.

 

Name

  Age  

Position

John S. Yu, M.D.

  47  Chairman of the Board

Manish Singh, Ph.D. (4)

  42  President, Chief Executive Officer and Director

James Bender, Ph.D.

  61  Vice President – Product Development and Manufacturing

David Fractor

  51  Treasurer and Chief Financial Officer

Rahul Singhvi, Sc.D.(1)(2)(3)(4)

  46  Lead Director

Jacqueline Brandwynne(1)(2)

  73  Director

Richard A. Cowell(2)(3)

  63  Director

Navdeep Jaikaria, Ph.D.(1)(2)(3)(4)

  48  Director

 

(1)

Member of our Compensation Committee

(2)

Member of our Nominating and Corporate Governance Committee

(3)

Member of our Audit Committee

(4)

Member of Our Finance Committee

Business Experience and Directorships

The following describes thebackgrounds of current executive officers and directors. Our Board of Directors has determined that (1) all of our directors other than Dr. Singh are independent directors as defined in the Nasdaq rules governing members of boards ofdirectors and (2) the members of our Audit Committee are independent under applicable SEC rules. Under his current right to designate two other members of our Board of Directors, Dr. Yu designated Dr. Robert Martuza in December 2006and Jacqueline Brandwynne in January 2007 to serve as two of our directors. Dr. Martuza resigned as a director in February 2011.

 

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John S. Yu, M.D., Chairman of the Board

Dr. Yu served as our Chief Scientific Officer and as a director from November 2006 to January 2007, when he became our Chairman ofthe Board. He is a member of the full-time faculty in the Department of Neurosurgery at Cedars-Sinai Medical Center. An internationally renowned neurosurgeon, Dr. Yu’s clinical focus is on the treatment of malignant and benign brain andspinal tumors. He is also conducting extensive research in immune and gene therapy for brain tumors. He has also done extensive research in the use of neural stem cells as delivery vehicles for brain cancers and neurodegenerative diseases. He wasinducted into Castle and Connelly’s America’s Top Doctors in 2005. Dr. Yu has published articles in a number of prestigious journals, including The Lancet, Cancer Research, Cancer Gene Therapy, Human Gene Therapy, Journal ofNeuroimmunology, Journal of Neurological Science and Journal of Neurosurgery. Dr. Yu earned his bachelor’s degree in French literature and biological sciences from Stanford University and spent a year at the Sorbonne in Paris studyingFrench literature. He also pursued a fellowship in immunology at the Institut Pasteur in Paris. He earned his medical degree from Harvard Medical School and master’s degree from the Harvard University’s Department of Genetics. He completedhis neurosurgical residency at Massachusetts General Hospital in Boston. In addition, he was a Neuroscience Fellow at the National Institutes of Mental Health in the Neuroimmunology Unit at Massachusetts General Hospital from 1988 to 1989 and was aCulpepper Scholar at the Molecular Neurogenetics Unit at that hospital from 1993 to 1995. His other honors include the Preuss Award, Joint Section on Tumors, American Association of Neurological Surgeons and Congress of Neurologic Surgeons in 1995.He received the Academy Award from the American Academy of Neurological Surgery at its 1996 annual meeting. Other honors include the Young Investigator Award from the Congress of Neurological Surgeons in 2000, the National Brain Tumor FoundationGrant in 2001, and the Mahaley Clinical Research award from the American Association of Neurological Surgeons in 2005.

Dr. Yu, as a recognized leader in the field of neurosurgery, has extensive knowledge of current therapies and therapies underdevelopment for the treatment of brain tumors and has participated in numerous clinical trials for potential therapies in this field. As our Chief Scientific Officer and the co-inventor of our brain tumor vaccine technologies, Dr. Yu brings tothe Board significant scientific expertise directly relevant to our product research and development activities.

ManishSingh, Ph.D., President, Chief Executive Officer and Director

Dr. Singh has served as our President, Chief ExecutiveOfficer and as a director since February 2008. Dr. Singh served as a Director at California Technology Ventures, a venture capital firm from June 2003 to December 2007. He managed investments made by that venture capital firm in a number ofmedical device and biotechnology companies and served as a board director or board observer for several of the firm’s portfolio companies. From October 1995 to June 2002, he held various management and scientific positions with OdysseusSolutions, Cell Genesys, Chiron Corporation and Genetic Therapy, Inc. Dr. Singh has an MBA from UCLA, a Ph.D. in Chemical and Biochemical Engineering from the University of Maryland Baltimore County, an M.S. in Chemical Engineering fromWorcester Polytechnic Institute and a B.S. in Chemical Engineering from the Indian Institute of Technology, Roorkee.

Dr. Singh has had extensive prior experience as both an operating executive and board member in the biotechnology field. He alsobrings to the Board extensive knowledge and experience in the area of financing early stage healthcare companies through his prior work in the venture capital field.

James Bender, Vice President – Product Development and Manufacturing

Dr. Bender served as our Vice President – Clinical Development on a part time basis from September 2008 to February 2010 and hasserved as our Vice President – Product Development and Manufacturing on a full-time basis since February 2010. From 2002 through 2008 Dr. Bender held various positions at

 

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IDM Pharma, most recently as director of product development where he led that company’s efforts relating to the clinical development of a cancer vaccine for the treatment of lungcancer. Prior to that, he held various positions at Nexell Therapeutics relating to the development of therapeutic stem cell and cancer vaccine products. Prior to that, Dr. Bender spent 10 years with Baxter Healthcare Corporation, eight yearswith the University of New Mexico School of Medicine and five years with St. Joseph’s Hospital in Albuquerque, New Mexico. He has over 75 scientific publications, is an inventor of 11 U.S. patents and holds a Ph.D. degree in immunology from theUniversity of New Mexico and an M.P.H. in laboratory management from the University of Michigan.

David Fractor, Treasurerand Chief Financial Officer

Mr. Fractor has served as our Treasurer and Chief Financial Officer on a part-time basissince April 2011. Since 2003, Mr. Factor has been a consultant providing financial consulting and strategic planning services, including Sarbanes-Oxley compliance consulting services, to a variety of companies in a variety of industries. From1999 through 2003, Mr. Fractor was the Chief Finanical Officer of HemaCare Corporation, a publicly traded corporation which collects, manufactures, tests and distributes blood products to hospitals and provides blood services to patients inhospital settings on an outsourcing basis. Mr. Fractor received his B.S. in Accounting from the University of Southern California in 1982 and is a certified public accountant and a member of AICPA and the California Society of CPA’s.

Rahul Singhvi, Sc.D., Lead Director

Dr. Singhvi has served as a director since June 2010 and as Lead Director since December 2010. He has been with Novavax, Inc., a biopharmaceutical company focused on developing novel, highly potentrecombinant vaccines since 2004 and has served as President, Chief Executive Officer and Director of Novavax since August 2005. Dr. Singhvi was the Senior Vice President and Chief Operating Officer of Novavax from April 2005 to August 2005 andVice President - Pharmaceutical Development and Manufacturing Operations from April 2004 to April 2005. For ten years prior to joining Novavax, he served in various positions with Merck & Co., Inc., culminating as Director of the MerckManufacturing Division., where he helped develop several vaccines including Zostavax®, the only vaccine on the market to prevent shingles. Dr. Singhvi received his M.S. and Sc.D. degree in Chemical Engineering from the MassachusettsInstitute of Technology. He also holds an M.B.A. from the Wharton School.

Dr. Singhvi currently serves as the Presidentand Chief Executive Officer of a public biopharmaceutical company and brings to the Board experience and knowledge in the operation and leadership of early stage public healthcare companies. He also has extensive expertise and experience in thedevelopment and manufacturing of vaccines, which may assist the Board in its oversight of our cancer vaccine programs.

Jacqueline Brandwynne, Director

Ms. Brandwynne has served as a director since January 2007. Since 1981, Ms. Brandwynne has served as President and CEO of Brandwynne Corporation, which has co-founded and assisted in thedevelopment of several healthcare and biotech companies. Ms. Brandwynne is a business strategist with more than 25 years of experience working with companies such as American Cyanimid, Bristol Myers/Clairol, National Liberty Life,Seagram & Sons and Neutrogena. From 1974 to 1981 she was in charge of developing Citicorp’s global business strategy. From 2000 to 2006, Ms. Brandwynne was a director of Microvision, Inc., a public company that developssophisticated miniature displays. She has served in multiple advisory roles in several administrations, including as an Advisor to the Council of Economic Advisors, a member of the US Trade Representatives Services Policy Advisory Committee, anegotiator of the North American Trade Agreement, a participant in GATT negotiations and a member of The Committee on Critical Choices for America, and Chair of an Economic Summit at the White House. She currently serves on the board of the ProteusVenture Biotech Fund and on several non-profit boards, including the Cedars-Sinai Health Systems Board of Governors. Ms. Brandwynne also serves on the Board of Advisors of Histogen, Inc.

 

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Ms. Brandwynne’s extensive involvement with early stage healthcare and biotechcompanies provides the Board with valuable expertise in the operation and development of the Company. With an extensive background as a business strategist for major corporations she also assists the Board in its strategic planning activities.

Mr. Richard A. Cowell, USA, (Ret.), Director

Mr. Richard A. Cowell, USA, (Ret.) has served as a director since June 2007. Mr. Cowell is a Principal at Booz AllenHamilton, Inc., where he is involved in advanced concepts, technology experimentation and integration, and establishing new business operations. Prior to joining Booz Allen Hamilton in March 1996, Mr. Cowell served in the United States Army for25 years. Mr. Cowell serves as a director and Chair of the Audit Committee for Microvision, Inc. He holds a Top Secret security clearance with special accesses based on a special background investigation. Mr. Cowell holds a B.S. degree inaccounting from Ohio State University.

Mr. Cowell brings to the Board both financial and accounting expertise as well asexperience in the handling of Audit Committee matters for a public company. As consultant with a major consulting firm in the fields of technology experimentation and establishing new business operations, he brings to the Board strategic andbusiness planning experience.

Navdeep Jaikaria, Ph.D., Director

Dr. Jaikaria has served as a director since June 2008. He currently is CEO of SGN Advisors, Inc., an advisory firm that conductsglobal biopharmaceutical due diligence for private equity funds and hedge funds as well as companies. Dr. Jaikaria held various positions with Rodman & Renshaw from 2003 until 2008, when he retired as Managing Director, Senior EquityResearch Analyst – Biotechnology. Dr. Jaikaria previously held positions in equity research with Leerink Swann and Mehta Partners from 2000 to 2003 and consulting positions with Merck & Co. and Antigenics, Inc. from 1996 until1999. Dr. Jaikaria holds a Ph.D. in Cell Biology and Anatomy from New York Medical College, conducted a research fellowship at Rockefeller University and holds a B.S. in Human Biology from All India Institute of Medical Sciences.

As a highly regarded and experienced former healthcare analyst for major healthcare investment banks, Dr. Jaikaria brings to theBoard extensive healthcare industry knowledge in the area of capital raising and investment banking as well as a broad understanding of the healthcare market and competitive conditions.

Committees of the Board

Our Board of Directors has established an AuditCommittee currently consisting of Mr. Cowell, as Chairman, and Drs. Jaikaria and Singhvi.

The Audit Committeeassists the Board of Directors in fulfilling its oversight responsibilities relating to:

 

  

the quality and integrity of our financial statements and reports;

 

  

the independent auditors’ qualifications and independence; and

 

  

the performance of our internal audit function and independent auditors.

The Audit Committee appoints the independent auditors, reviews with the independent auditors the plans and results of the auditengagement, approves permitted non-audit services provided by our independent auditors and reviews the independence of the auditors. The Audit Committee currently consists of Mr. Cowell, as Chairman, and Drs. Jaikaria and Singhvi.Mr. Cowell has been designated as an “audit committee financial expert” as defined under Item 407(d)(5) of Regulation S-K of the Exchange Act.

 

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Our Board of Directors has established a Compensation Committee currently consisting ofDr. Jaikaria, as Chairman, Ms. Brandwynne, and Dr. Singhvi. The Compensation Committee reviews, and makes recommendations to the full Board of Directors relating to, the compensation of our officers and directors, including ourofficers’ annual salaries and bonuses and the terms and conditions of option grants to our officers and directors under our stock incentive plan.

Our Board of Directors has established a Nominating and Corporate Governance Committee currently consisting of Ms. Brandwynne, as Chairwoman, Mr. Cowell, Dr. Jaikaria and Dr. Singhvi.The Nominating and Corporate Governance Committee develops and recommends corporate governance guidelines to the Board, selects or recommends for selection nominees to serve on the Board, and oversees the evaluation of the Board and its committees.

Our Board of Directors has established a Finance Committee currently consisting of Dr. Singhvi, as Chairman, andDr. Jaikaria and Dr. Singh. The Finance Committee has oversight responsibility for all material financial matters affecting the Company, including capital management, funding strategy and investing activities related to our financialposition and financing activities.

Scientific Advisory Board

We have established a Scientific Advisory Board (“SAB”) currently consisting of Dr. Keith Black, as Chairman, Dr. Peter Brooks, Dr. Sherie Morrison, Dr. Cohava Gelber,Dr. George Peoples, Dr. Constantine Ioannides and Dr. Zvi Ram to assist our management in the areas of expertise of the members of our SAB. We have compensated the members of our SAB from time to time through the grant of options topurchase our stock. In September 2009, we granted a five-year non-qualified option to purchase 10,000 shares of our common stock to each of four members of our SAB for service as members on the SAB for the coming year at an exercise price of $0.95per share, with such option to vest quarterly for the one-year period following the date of grant. In May 2010, we also granted a five-year non-qualified option to purchase 10,000 shares of our common stock to another member of our SAB for servicesas a member for the coming year at an exercise price of $1.20 per share, with such option to vest quarterly for the one-year period following the date of grant.

Keith L. Black, M.D.

Dr. Black has served on our Scientific AdvisoryBoard since January 2007. Dr. Black serves as Chairman of the Department of Neurosurgery and Director of the Maxine Dunitz Neurosurgical Institute at Cedars-Sinai Medical Center. An internationally renowned neurosurgeon and scientist,Dr. Black joined Cedars-Sinai Medical Center in July 1997 and was awarded the Ruth and Lawrence Harvey Chair in Neurosciences in November of that year. Prior to joining Cedars-Sinai, Dr. Black served on the University of California, LosAngeles (UCLA) faculty for 10 years where he was a Professor of Neurosurgery. In 1992 he was awarded the Ruth and Raymond Stotter Chair in the Department of Surgery and was Head of the UCLA Comprehensive Brain Tumor Program.

Dr. Black serves on the editorial boards of Neurological Research, Gene Therapy and Molecular Biology, NeurosurgeryQuarterly and Frontiers In Bioscience. He was on the National Institutes of Health’s Board of Scientific Counselors for Neurological Disorders and Stroke and was appointed to the National Advisory Neurological Disorders and Stroke Councilof the National Institutes of Health from 2000 to 2004. He was also selected as a committee member of the California Institute for Regenerative Medicine Independent Citizens Oversight Committee from 2004-2006.

Dr. Black pioneered research on designing ways to open the blood-brain barrier, enabling chemotherapeutic drugs to be delivereddirectly into the tumor for which he received the Jacob Javits award from the National Advisory Neurological Disorders and Stroke Council of the National Institutes of Health in June 2000. Other groundbreaking research done by Dr. Black focusedon developing a vaccine to enhance the body’s immune response to brain tumors, use of gene arrays to develop molecular profiles of tumors, the use of optical technology for brain mapping, and the use of focused microwave energy to noninvasivelydestroy brain tumors.

 

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Dr. Black has published extensively and has five patents issued or pending.Dr. Black was featured on the cover of Time magazine in the Fall 1997 special edition “Heroes of Medicine” and was profiled in 1996 on the PBS program, The New Explorers, in an episode called “Outsmarting the Brain.”

John Boockvar, M.D.

Dr. Boockvar currently is Co-Director of the Brain and Spinal Tumor Program at Weill Cornell Medical College. Dr. Boockvar heads the Brain Tumor and Stem Cell Research Laboratory and directs theinstitution’s Brain Tumor Research Group. Dr. Boockvar’s laboratory interests have focused on studying adult human neural stem cell biology to investigate brain tumor formation and brain tumor and stem cell migration and survival.Dr. Boockvar served as Editor-in-Chief of the journal Current Stem Cell Research and Therapy and is an editorial board member of the journal Neurosurgery, and Recent Patents on Anti-Cancer Drug Discovery. He is an ad-hoc reviewer forNeurosurgery, Brain Research and Human Gene Therapy. He is a member of the Executive Committee (2009-2011) of the Joint Section of Brain Tumors of the American Association of Neurological Surgeons and Congress of Neurological Surgeons.Dr. Boockvar is the principal investigator of new clinical trials using super selective intraarterial infusion techniques for the delivery of novel therapeutics such as Avastin or Cetuximab for the treatment of malignant brain cancer.Dr. Boockvar received a B.A. and graduated Cum Laude from the University of Pennsylvania. Dr. Boockvar received an M.D. from SUNY Brooklyn-Downstate Medical Center where he graduated Summa Cum Laude with Distinction in Research.Dr. Boockvar did his surgical internship and neurosurgical residency at the Hospital of the University of Pennsylvania. Dr. Boockvar did specialized NIH/National Cancer Institute supported fellowship training in Neuro-oncology (Brain andSpinal Tumors) at the University of Pennsylvania Cancer Center.

Peter Brooks, Ph.D.

Dr. Brooks has served on our Scientific Advisory Board since October 2008. Dr. Brooks serves as a Senior Scientist at the MaineMedical Center Research Institute, where he is focused on studying mechanisms that regulate angiogenesis, tumor growth and metastasis. Prior to joining that Institute, Dr. Brooks served as associate professor and director of Antiogenesis andRadiation Research at New York University (NYU) School of Medicine. Prior to association with NYU, Dr. Brooks was an assistant professor at the USC School of Medicine, during which time he co-founded Cell Matrix Incorporated, a biotechnologycompany focuses on anti-antiogenic drugs targeting cryptic ECM epitopes. Dr. Brooks’ studies have led to a recent clinical trial to evaluate the effects of D93, a humanized antibody directed to a cryptic collagen epitope for the treatmentof malignant tumors. Dr. Books obtained his Ph.D. in Cell and Developmental Biology from the State University of New York at Stony Brook.

Cohava Gelber, Ph.D.

Dr. Gelber currently serves as the ChiefScientific & Technology Officer of ATCC, a position she has held since 2005. In this capacity she is responsible for a large group of scientists in numerous disciplines. Prior to joining ATCC, she served as Vice President - Research andDevelopment for MannKind Corp., a public company developing therapeutics for diabetes, cancer and autoimmune diseases. She was responsible at that company for non clinical development and clinical immune safety of drugs from pre IND through phaseIII clinical trials. Dr. Gelber received her Ph.D. from the Weizmann Institute, her MBA degree from Cornell University and post doctorate training at Stanford University. Dr. Gelber has published numerous scientific manuscripts andtextbook chapters and is the inventor of 7 granted patents and 49 patent applications. Dr. Gelber is one of the inventors of several monoclonal antibodies that we are developing, including ICT-69 and ICT-109, and has served as a consultant toour company in the past two years.

 

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Constantine Ioannides, Ph.D.

Dr. Ioannides is a well-known and highly respected cancer immunologist, with over one hundred peer-reviewed articles in thescientific literature. Dr. Ioannides’s current primary research interests are focused specifically on cancer stem cells. Dr. Ioannides has been involved with some of the most important advancements in the field of cancer immunologyover the past 20 years and is the co-discoverer of the NeuVaxT (E75) vaccine. We recently entered into an option agreement with M.D. Anderson Cancer Center for some of the cancer stem cell technologies that were developed atDr. Ioannides’s laboratory.

Sherie Morrison, Ph.D.

Dr. Morrison is a distinguished professor of Microbiology, Immunology and Molecular Genetics at the University of California, LosAngeles. Dr. Morrison joined the faculty of UCLA in 1988 and acted as department chair for 10 years. Prior to that, Dr. Morrison served as professor in the Department of Microbiology at Columbia University College of Physicians andSurgeons, which followed various post-doctoral fellowships at Columbia University, University of California, Berkeley and Albert Einstein College of Medicine. Her long-time research interest has been the functional properties of antibodies and novelantibody-related proteins, and she is well published in this area. Dr. Morrison holds Ph.D. and B.A. degrees from Stanford University.

George Peoples, M.D.

Dr. Peoples is the Director of the CancerVaccine Development Program and Deputy Director of the United States Military Cancer Institute. Prior to being appointed to that position, Dr. Peoples held positions as Chief of Surgical Oncology at the Walter Reed Army Medical Center andDirector of the Cancer Vaccine Developmental Laboratory. He received his medical degree from the Johns Hopkins School of Medicine prior to receiving surgical training at Harvard Medical School’s Brigham and Women’s Hospital, where he wasalso a research fellow. In addition to his appointments at some of the military’s most prestigious cancer research institutions, Dr. Peoples has significant research experience in the oncology field, with multiple peer-reviewedpublications to his credit, including co-discovery credits on HER2/neu vaccines and a number of other anti-cancer vaccines from his time at the M.D. Anderson Cancer Center, where he completed training in surgical oncology.

Zvi Ram, M.D.

Dr. Ram serves as the Chairman of the Department of Neurosurgery at Tel Aviv Medical Center in Israel. His emphasis is on brain tumor therapy, pituitary surgery, and technology development projectswith various companies. Dr. Ram is the Chairman of the European Association of Neurosurgical Societies (EANS) Neurooncology Committee, member of the Executive Steering Committees and lead PI for several pharmaceuticals companies conductingmulticenter international phase III clinical studies, scientific advisor for a number of biotechnology groups, and a member of editorial boards and reviewer for leading scientific journals in his areas of expertise. Dr. Ram previously led avariety of basic and clinical research projects, including leading the first gene therapy trial for patients with brain tumors, at the Surgical Neurology Branch at the National Institutes of Health in Bethesda, MD.

 

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EXECUTIVE COMPENSATION

The following table sets forth the compensation for services paid in all capacities for the two fiscal years ended December 31, 2010to Dr. Manish Singh, who has served as our President and Chief Executive Officer since February 18, 2008, and to C. Kirk Peacock, who served as our Interim President from November 5, 2007 to February 17, 2008 and who served asour Chief Financial Officer from May 16, 2005 to March 31, 2011.

Summary Compensation Table

 

Name and Principal

Position

 Year  Salary
($)
  Bonus
($)
  Stock
Awards
($)
  Option
Awards
($)(6)
  Non-Equity
Incentive Plan
Compensation
($)
  Nonqualified
Deferred
Compensation
Earnings
($)
  All Other
Compensation
($)
  Total
($)
 
Manish Singh, Ph.D.  2009   $243,750(1)  

 

—  

  

  —     $87,500(7)   —      —      —     $331,250  
President and Chief Executive Officer  2010   $293,287(2)  $100,000    —     

$

222,500

(8) 

    $615,787  
James Bender, Vice President – Product Development and Manufacturing  2010   $155,833(3)  $15,000    —      73,625(9)     $244,458  
C. Kirk Peacock 

 

2009

  

 $80,000(4)   —      —     $15,194(10)    —      —     

$

95,194

  

Chief Financial Officer  2010   $76,000(5)   —     $20,390(11)   —      —       $96,390  

 

(1)Includes $16,667 per month for the period from January 1, 2009 through February 17, 2009 and $20,833 from February 18, 2009 through December 31,2009 for services rendered to us as President and Chief Executive Officer.
(2)Includes $20,833 per month for the period from January 1, 2010 through February 17, 2010 and $25,000 from February 18, 2010 through December 31,2010 for services rendered to us as President and Chief Executive Officer.
(3)Includes $14,167 per month for the period from February 1, 2010 through December 31, 2010 for services as Vice President – Product Development andManufacturing.
(4)Includes $8,000 per month for the period from January 1, 2009 through April 30, 2009 and $6,000 from May 1, 2009 through December 31, 2009 forservices rendered to us as Chief Financial Officer and Treasurer.
(5)Includes $6,000 per month for the period from January 1, 2009 through October 31, 2010 and $8,000 per month from November 1, 2010 throughDecember 31, 2010 for services as Chief Financial Officer and Treasurer.
(6)This column represents option awards computed in accordance with FASB ASC Topic 718, excluding the effect of estimated forfeitures related to service-based vestingconditions. For additional information on the valuation assumptions with respect to the option grants, refer to Note 2 of our financial statements in this Annual Report. These amounts do not correspond to the actual value that will be recognized bythe named executives from these awards.
(7)

Includes (i) a seven-year option to purchase 600,000 shares of our common stock granted February 18, 2008 at an exercise price of $1.00 pershare, vesting monthly over a one-year period following the date of grant and (ii)

 

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a seven-year option to purchase 300,000 shares of our common stock granted February 18, 2009 at an exercise price of $0.15 per share, vesting monthly over a one-year period following thedate of grant and (iii) a seven-year option to purchase 200,000 shares of our common stock granted February 18, 2009 at an exercise price of $0.15 per share, vesting if the Company achieves during term of the agreement either (a) avolume weighted average trading price for its common stock of greater than $1.00 for any 30-day period during the term of the agreement on average daily trading volume of at least 10,000 shares, or (b) working capital at the end of the term ofthe agreement of at least $5,000,000, for services rendered as President and Chief Executive Officer.

(8)Includes (i) a seven-year option to purchase 300,000 shares of our common stock granted February 18, 2009 at an exercise price of $0.15 per share, vestingmonthly over a one-year period following the date of grant, (ii) a seven-year option to purchase 360,000 shares of our common stock granted February 18, 2010 at an exercise price of $0.90 per share, vesting monthly over a one-year periodfollowing the date of grant, (iii) a seven-year option to purchase 240,000 shares of our common stock granted February 18, 2010 at an exercise price of $0.90 per share, vesting in certain increments if the Company achieves during term ofthe agreement (a) vesting of 30,000 shares for a volume weighted average trading price for its common stock of greater than $1.60 for any 15-day period during the term of the agreement on average daily trading volume of at least 20,000 shares,or (b) vesting of 90,000 shares for a volume weighted average trading price for its common stock of greater than $2.00 for any 15-day period during the term of the agreement on average daily trading volume of at least 20,000 shares, or(c) vesting of 30,000 shares for treating the first patient in a phase II clinical trial, or (d) vesting of 90,000 shares if the Corporation completes a financing, a strategic alliance or licensing agreement with upfront licensing paymentsto the Corporation or a merger or acquisition that generates at least $5,000,000 of net proceeds, for services rendered as President and Chief Executive Officer.
(9)Includes (i) a seven-year option to purchase 75,000 shares of our common stock granted February 1, 2010 at an exercise price of $0.90 per share, vestingmonthly over a one-year period following the date of grant, (ii) a seven-year option to purchase 25,000 shares of our common stock granted February 1, 2010 at an exercise price of $0.90 per share, vesting if the Company completes bySeptember 30, 2010 the tech transfer to a contract manufacturer organization for ICT-107, including without limitation validation/qualification runs, (iii) a seven-year option to purchase 25,000 shares of our common stock grantedFebruary 1, 2010 at an exercise price of $0.90 per share, vesting if the Company completes by December 31, 2010 FDA acceptance of a Phase II clinical trial plan for ICT-107, and (iv) a seven-year option to purchase 25,000 shares ofour common stock granted February 1, 2010 at an exercise price of $0.90 per share, vesting if the Company completes by December 31, 2010 enrollment of the first patient into the Phase II clinical trial for ICT-107, for services as VicePresident – Product Development and Manufacturing.
(10)Includes (i) a seven-year option to purchase 50,000 shares of our common stock granted October 30, 2008 at an exercise price of $0.30 per share, vestingmonthly over a one-year period following the date of grant, for services rendered as Chief Financial Officer and Treasurer commencing October 30, 2008 and (ii) a seven-year option to purchase 50,000 shares of our common stock grantedOctober 30, 2009, at an exercise price of $0.80 per share, vesting monthly over a one-year period following the date of grant, for services rendered as Chief Financial Officer and Treasurer commencing October 30, 2009 and (iii) aseven-year option to purchase 6,000 shares of our common stock granted October 30, 2009, at an exercise price of $0.80 per share, vesting upon the completion of the Company’s internal documentation and internal testing necessary tosubsequently complete the Company’s Sarbanes-Oxley Section 404 audit.
(11)Includes 19, 231 shares of restricted common stock, vesting monthly over a five-month period following the date of grant, for services rendered as Chief FinancialOfficer and Treasurer.

Stock Option Grants

The following table sets forth information as of December 31, 2010 concerning unexercised options, unvested stock and equity incentive plan awards for the executive officers named in the SummaryCompensation Table.

 

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OUTSTANDING EQUITY AWARDS AT YEAR ENDED DECEMBER 31, 2010

 

   Option Awards   Stock Awards 

Name

  Number of
Securities
Underlying
Unexercised
Options

(#)
Exercisable
  Number of
Securities
Underlying
Unexercised
Options

(#)
Unexercisable
  Equity
Incentive
Plan
Awards:
Numberof
Securities
Underlying
Unexercised
Unearned
Options

(#)
   Option
Exercise
Price

($)
   Option
Expiration
Date
   Number of
Shares or
Units of
Stock That
Have Not
Vested
(#)
   Market
Value of
Shares or
Units of
Stock That
HaveNot
Vested
($)
   Equity
Incentive
Plan
Awards:
Number of
Unearned
Shares,
Unitsor
Other
Rights That
Have Not
Vested
(#)
   Equity
Incentive
Plan
Awards:
Market or
Payout
Valueof
Unearned
Shares,
Units or
Other
Rights That
Have Not
Vested
($)
 

Manish Singh, Ph.D.

   700,000 (1)     $1.00     02-17-15          
   25,000 (2)      0.27     09-28-15          
   250,000 (8)   50,000 (8)     0.15     02-17-16          
    400,000 (9)     0.15     02-17-16          
   7,846 (10)   23,538 (10)     0.95     09-13-16          

C. Kirk Peacock

   50,181(3)   —        0.35     05-15-10          
   25,000(4)   —        1.00     10-29-13          
   50,000(5)   —        1.00     10-29-13          
   50,000(6)   —        1.30     10-29-14          
   50,000 (7)      0.30     10-29-15          
   50,000 (11)      0.80     10-29-16          

James Bender

   36,000 (12)      0.68     8-31-15          
   15,000 (13)      0.95     8-31-16          
   5,000 (14)   5,000 (15)     0.95     8-31-16          
   68,750 (16)   6,250 (16     0.90     1-31-17          
   50,000 (17)      0.90     1-31-17          

 

(1)Vested monthly following grant on February 18, 2008
(2)Vested 25% quarterly following grant on September 29, 2008
(3)Vested monthly following grant on May 16, 2005.
(4)Vested upon grant, October 30, 2006.
(5)Vested 25% quarterly following grant on October 30, 2006.
(6)Vested monthly following grant on October 30, 2007.
(7)Vested monthly following grant on October 30, 2008.
(8)Vested monthly following grant on February 18, 2009 as to 300,000 shares.
(9)Vests upon completion of milestones pursuant to contract.
(10)Vests 25% quarterly following grant on September 14, 2009.
(11)Vests monthly following grant on October 30, 2009.
(12)Vested monthly following grant on September 1, 2008.
(13)Vests 3,000 shares monthly following grant on September 1, 2009
(14)Vested upon achievement of milestone pursuant to contract.
(15)Vests upon completion of milestones pursuant to contract.
(16)Vests monthly following grant on February 1, 2010.
(17)Vests upon completion of milestones pursuant to contract.

 

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Compensation of Directors

The following table sets forth information concerning the compensation paid to each of our non-employee directors during 2010 for their services rendered as directors. The non-employee directors also eachreceived 10,000 shares of our restricted common stock as part of their annual compensation with such grant to vest 25% on January 4, 2011, 25% on March 27, 2011, 25% on June 27, 2011 and 25% on September 27, 2011. Thecompensation of Dr. Singh, who serves as a director and as our President and Chief Executive Officer, is described above in the Summary Compensation Table.

DIRECTOR COMPENSATION FOR FISCAL YEAR 2010

 

Name

 Fees
Earned
or Paid
in Cash
  Stock
Awards
  Option
Awards
(1)(7)
  Non-Equity
Incentive Plan
Compensation
  Nonqualified
Deferred
Compensation
Earnings
  All Other
Compensation
  Total 

Jacqueline Brandwynne

 $20,500    —     $27,900(2)   —      —      —     $48,400  

Richard A. Cowell

 $24,500    —     $34,100(3)   —      —      —     $58,600  

Navdeep Jaikaria

 $24,250    —     $34,100(4)   —      —      —     $58,350  

Robert L. Martuza

 $27,000    —      —      —      —      —     $27,000  

Rahul Singhvi

 $13,861    —     $41,900(5)   —      —      —     $55,761  

John Yu

 $30,750    —     $31,000(6)   —      —      —     $61,750  

 

(1)This column represents the aggregate grant date fair value of options awarded computed in accordance with FASB ASC Topic 718, excluding the effect of estimatedforfeitures related to service-based vesting conditions. For additional information on the valuation assumptions with respect to the option grants, refer to Note 2 of our financial statements in this Annual Report. These amounts do notcorrespond to the actual value that will be recognized by the named directors from these awards.
(2)On September 27, 2010 we granted to Ms. Brandwynne a seven-year non-qualified option to purchase 45,000 shares of the Company’s common stock at anexercise price of $0.90 per share, vesting quarterly over a one-year period for her services as a director.
(3)On September 27, 2010 we granted to Mr. Cowell a seven-year non-qualified option to purchase 55,000 shares of the Company’s common stock at an exerciseprice of $0.90 per share, vesting quarterly over a one-year period for his services as a director.
(4)On September 27, 2010 we granted to Dr. Jaikaria a seven-year non-qualified option to purchase 55,000 shares of the Company’s common stock at an exerciseprice of $0.90 per share, vesting quarterly over a one-year period for his services as a director.
(5)On September 27, 2010 we granted to Dr. Yu a seven-year non-qualified option to purchase 50,000 shares of the Company’s common stock at an exercise priceof $0.90 per share, vesting quarterly over a one-year period for his services as a director.
(6)As of December 31, 2010, our non-employee directors held vested and unvested options, which they received as compensation for their services as directors, topurchase the following number of shares of our common stock: Jacqueline Brandwynne – 170,401 shares; Richard A. Cowell – 218,301 shares; Navdeep Jaikaria – 55,000 shares; Robert L. Martuza – 137,767 shares; and John Yu –176,068 shares.

Stock Incentive Plan

We have adopted an equity incentive plan, the 2006 Equity Incentive Plan, as amended (the “Equity Plan”), pursuant to which we are authorized to grant options, restricted stock and stockappreciation rights to purchase up to 6,000,000 shares of common stock to our employees, officers, directors, consultants and advisors. Awards under the plan may consist of stock options (both non- qualified options and options intended to qualifyas “Incentive Stock Options” under Section 422 of the Internal Revenue Code of 1986, as amended), restricted stock awards and stock appreciation rights.

 

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The Equity Plan is administered by our Board of Directors or a committee appointed by theBoard, which determines the persons to whom awards will be granted, the type of award to be granted, the number of awards to be granted and the specific terms of each grant, including the vesting thereof, subject to the provisions of the plan.

The Equity Plan provides that the exercise price of each incentive stock option may not be less than the fair market value ofour common stock on the date of grant (or 110% of the fair market value in the case of a grantee holding more than 10% of our outstanding common stock). The exercise price of a non-qualified stock option shall be no less than the fair market valueof the common stock on the date of grant. The maximum number of options that may be granted in any fiscal year to any participant is 725,000.

The plan also permits the grant of freestanding stock appreciation rights or in tandem with option awards. The grant price of a stock appreciation right shall be no less than the fair market value of ashare on the date of grant of the stock appreciation right. No stock appreciation right shall be exercisable later than the tenth anniversary of its grant. Upon the exercise of a stock appreciation right, a participant shall be entitled to receivecommon stock at a fair market value equal to the benefit to be received by the exercise.

The plan also provides us with theability to grant or sell shares of common stock that are subject to certain transferability, forfeiture, repurchase or other restrictions. The type of restriction, the number of shares of restricted stock granted and other such provisions shall bedetermined by our Board of Directors or its committee.

Unless otherwise determined by our Board of Directors or itscommittee, awards granted under the Equity Plan are not transferable other than by will or by the laws of descent and distribution.

The Equity Plan provides that, except as set forth in an individual award agreement, upon the occurrence of a corporate transaction: (i) our Board of Directors or its committee shall notify eachparticipant at least 30 days prior to the consummation of the corporate transaction or as soon as may be practicable and (ii) all options and stock appreciation rights shall terminate and all restricted stock shall be forfeited immediatelyprior to the consummation of such corporate transaction unless the committee determines otherwise in its sole discretion. A “corporate transaction” means (i) a liquidation or dissolution of the company; (ii) a merger orconsolidation of the company with or into another corporation or entity (other than a merger with a wholly-owned subsidiary); (iii) a sale of all or substantially all of the assets of the company; or (iv) a purchase or other acquisition ofmore than 50% of the outstanding stock of the company by one person or by more than one person acting in concert.

Our Boardof Directors may alter, amend or terminate the plan in any respect at any time, but no alteration, amendment or termination will adversely affect in any material way any award previously granted under the plan, without the written consent of theparticipant holding such award.

As of December 31, 2010, there were outstanding options under the Equity Plan topurchase approximately 3,761,421 shares of our common stock at a weighted average exercise price of approximately $0.78 per share and 61,537 shares of unvested restricted stock. The grants of options and restricted stock under the Equity Plan during2010 are described below.

In December 2010, we granted 10,000 restricted shares of our common stock to each of five of ournon-employee directors as part of their compensation for services as a director with such shares to vest in four equal installments on January 4, 2011, March 27, 2011, June 27, 2011, and September 27, 2011.

 

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In September 2010, we granted a non-qualified option to purchase shares of common stockto each of our directors for their service as a director for the one-year period commencing September 27, 2010. Each of the options granted to the directors has a term of seven years, has an exercise price of $0.90 per share, vests in fourequal quarterly installments following the date of grant, and may be exercised within their term during the period the grantee provides services to us and for 24 months after the grantee ceases providing services for any reason other thantermination by us for cause. The amounts of the annual grants were: Jacqueline Brandwynne, 45,000 shares; Richard Cowell, 55,000 shares; Dr. Navdeep Jaikaria, 55,000 shares; Dr. Manish Singh, 30,000 shares; Dr. Rahul Singhvi, 55,000shares and Dr. John Yu, 65,000 shares.

In June 2010, we granted a non-qualified option to purchase 12,500 shares ofcommon stock at an exercise price of $1.14 per share to Dr. Rahul Singhvi for his service on our board until the next annual grant, with such option to vest in four equal quarterly installments following the date of grant, and may be exercisedwithin its term during the period the grantee provides services to us and for 24 months after the grantee ceases providing services for any reason other than termination by us for cause.

In June 2010, we granted a five-year non-qualified option to purchase 10,000 shares of our common stock at an exercise price of $1.10 pershare to Dr. John Boockvar for service as a member of our Scientific Advisory Board, with such option to vest in four equal quarterly installments for the one-year period following the date of grant.

In May 2010, we granted a five-year non-qualified option to purchase 10,000 shares of our common stock at an exercise price of $1.20 pershare to Dr. Ram Zvi for service as a member of our Scientific Advisory Board, with such option to vest in four equal quarterly installments for the one-year period following the date of grant.

In March 2010, we granted a five-year non-qualified option to purchase 150,000 shares of our common stock at an exercise price of $0.90to Dr. Elma Hawkins for services as Consultant – Clinical Affairs, with such option to vest as to 100,000 shares in equal monthly installments for one year following the date of grant, and 50,000 shares to vest upon the achievement ofcertain specified milestones.

In March 2010, we granted a seven-year non-qualified option to purchase 125,000 shares of ourcommon stock at an exercise price of $0.90 to Dr. John Yu for services rendered as our Chief Scientific Officer, with 75,000 shares of such option to vest in four equal quarterly installments following the date of grant and with 50,000 sharesof such option to vest in accordance with the achievement of milestones contained in his employment agreement, and such option may be exercised within its term during the period the grantee provides services to us and for 24 months after the granteeceases providing services for any reason other than termination by us for cause.

In February 2010, we granted a seven-yearincentive option to purchase 600,000 shares of our common stock at an exercise price of $0.90 per share to Dr. Manish Singh upon the renewal of his employment as our President and Chief Executive Officer, with 360,000 of the shares to vest atthe rate of 30,000 shares per month during the term of his agreement and with the remaining 240,000 shares to vest in accordance with the achievement of milestones contained in his employment agreement, and such option may be exercised within itsterm during the period the grantee provides services to us and for 24 months after the grantee ceases providing services for any reason other than termination by us for cause.

In February 2010, we granted a seven-year non-qualified option to purchase 150,000 shares of our common stock at an exercise price of $0.90 per share to James Bender in accordance with his employmentagreement to serve as our Vice President – Product Development and Manufacturing for a one-year term, with such option to vest at the rate of 6,250 shares per month during the term of the employment agreement and with the remaining 75,000shares to vest in accordance with the achievement of milestones contained in his employment agreement.

 

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Employment Agreements

John S. Yu, M.D.

Dr. John Yu and the Company entered into anAgreement, dated as of November 17, 2006, and a related Securities Purchase Agreement, dated as of November 17, 2006, Non-qualified Stock Option Agreement, dated as of November 17, 2006 and Registration Rights Agreement, dated as ofNovember 17, 2006. Under that Agreement, Dr. Yu agreed to serve as our Chief Scientific Officer for an initial one-year term on a part-time basis. Pursuant to that Agreement, the Company agreed that (i) for so long as Dr. Yu ownsCompany shares or fully vested immediately exercisable options to purchase Company shares totaling at least 2,000,000 shares, the Company will use commercially reasonable efforts to enable Dr. Yu to continue to serve on its Board of Directorsand (ii) for so long as Dr. Yu owns shares of the Company’s common stock or fully vested immediately exercisable options to purchase shares of the Company’s common stock totaling at least 4,000,000 shares or at least 5,000,000shares, the Company will use commercially reasonable efforts to enable Dr. Yu and either one or two, respectively, of his designees to serve on its Board of Directors.

Effective March 1, 2010, the Company entered into an Agreement with Dr. Yu under which he agreed to serve on a part-time basis as the Company’s Chief Scientific Officer for a one-year term.The Agreement provides for an annual base salary of $70,000 and for cash bonuses of $15,000 each if prior to December 31, 2010 (i) the FDA has accepted a Phase II clinical trial plan for ICT-107 and (ii) a Physicians InvestigatorIND submission for one of the Company’s specified product candidates has been accepted by the FDA. Subsequent to February 28, 2011, Dr. Yu has continued to serve as the Company’s Chief Scientific Officer under the terms of theforegoing Agreement pending the negotiation of a new agreement.

Pursuant to the Agreement, the Company granted to Dr. Yua seven-year nonqualified stock option under the Company’s 2006 Equity Incentive Plan, or a new qualified option plan, to purchase 125,000 shares of the Company’s common stock at an exercise price equal to $0.90 per share, which was theclosing market price of the common stock on the option grant date. The option grant is subject to the approval by the Company’s stockholders of an increase in the authorized number of shares under the Plan. The option may be exercised duringthe period that Dr. Yu provides services to the Company and for 24 months after termination for any reason except termination for cause by the Company, provided that such exercise is within the seven-year term of the option.

The option granted to Dr. Yu under the Agreement will vest (i) as to 75,000 shares in four equal quarterly installmentsfollowing the date of grant and (ii) as to the remaining 50,000 shares, 25,000 shares shall each vest upon timely satisfying the two milestones described above for the payment of cash bonuses to Dr. Yu.

Manish Singh, Ph.D.

Effective February 18, 2009, the Company entered into an Employment Agreement with Dr. Manish Singh (the “2009 Employment Agreement”) pursuant to which Dr. Singh continued toserve on a full-time basis as the Company’s President and Chief Executive Officer for a one-year term. The Company was required under the 2009 Employment Agreement to use its commercially reasonable efforts to have Dr. Singh continue toserve as a member of the Company’s Board of Directors during the term of the 2009 Employment Agreement.

The 2009Employment Agreement provided for an annual base salary of $250,000 and cash bonuses of (1) $50,000 if the Company completed a financing, a strategic alliance or a merger or acquisition that generates at least $2,500,000 of net proceeds (aftercommissions) during the term of the agreement; (2) $100,000 if the Company completed a financing, a strategic alliance or a merger or acquisition that generates at least $5,000,000 of net proceeds (after commissions) during the term of theagreement; or (3) $200,000 if the Company completed a financing, a strategic alliance or a merger or acquisition that generates at least

 

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$10,000,000 of net proceeds (after commissions) during the term of the agreement. The total cash bonus payable would in no event exceed $200,000. Pursuant to the 2009 Employment Agreement, theCompany granted Dr. Singh a seven-year non-qualified stock option on February 18, 2009 under the Equity Plan to purchase 700,000 shares of the Company’s common stock at an exercise price of $0.15 per share. The option vests(i) as to 300,000 shares in twelve equal monthly installments of 25,000 shares each over the twelve-month period from and immediately following the grant date, (ii) as to 200,000 shares if the Company achieved during term of theagreement either (a) a volume weighted average trading price for its common stock of greater than $1.00 for any 30-day period during the term of the agreement on average daily trading volume of at least 10,000 shares, or (b) workingcapital at the end of the term of the agreement of at least $5,000,000; and (iii) as to 200,000 shares if the Company achieved during term of the agreement either (a) a volume weighted average trading price for its common stock of greaterthan $1.50 for any 30-day period during the term of the agreement on average daily trading volume of at least 10,000 shares or (b) working capital at the end of the term of the agreement of at least $8,000,000. The option may be exercisedduring the period that Dr. Singh provides services to the Company and for 24 months after termination for any reason except termination for cause by the Company, provided that such exercise is within the seven-year term of the option.

In the event that the Company terminated the 2009 Employment Agreement without cause or did not extend the 2009 EmploymentAgreement upon its expiration for an additional one-year term or Dr. Singh terminated the 2009 Employment Agreement due to (1) his principal place of work for the Company being relocated by more than 50 miles, (2) a material change inhis duties, (3) a failure by the Company to pay him any of his contractual compensation, or (4) a constructive termination of Dr. Singh or unlawful harassment or retaliation against him, then the Company upon such termination wasrequired to make a lump sum payment to Dr. Singh equal to six months of his base annual salary and 50% of the shares covered by his option (or 100% of all such shares if the Company is not the surviving entity in a Corporate Transaction (asdefined by the Equity Plan) that had not yet vested would immediately become vested. In the event the Company completed a merger in which Dr. Singh was offered an executive position with the Company or surviving corporation for at least aone-year term, with an annual base salary of $250,000 and a cash bonus and option compensation package having an aggregate value of at least $75,000 (as determined in good faith by the Company or surviving corporation), Dr. Singh was notentitled to terminate the 2009 Employment Agreement based on a change in duties and responsibilities or a location change.

Effective as of February 18, 2010, the Company entered into a new Employment Agreement with Dr. Manish Singh (the “2010Employment Agreement”) pursuant to which Dr. Singh will continue to serve on a full-time basis as the Company’s President and Chief Executive Officer for a one-year term. The Company is required under the 2010 Employment Agreement touse its commercially reasonable efforts to have Dr. Singh continue to serve as a member of the Company’s Board of Directors during the term of the 2010 Employment Agreement. The 2010 Employment Agreement may be extended for an additionalone-year period upon the mutual agreement of the Company and Dr. Singh. Subsequent to February 17, 2010, Dr. Singh has continued to serve as the Company’s President and Chief Executive Officer under the terms of the 2010Employment Agreement pending the negotiation of a new employment agreement.

The 2010 Employment Agreement provides for anannual base salary of $300,000. In addition, provided that Dr. Singh continues to serve as the Company’s President and Chief Executive Officer for the entire one-year term of the 2010 Employment Agreement, the Company will payDr. Singh a discretionary cash bonus of up to $50,000 upon completion of the one-year term.

The 2009 EmploymentAgreement with Dr. Singh provided that Dr. Singh was entitled to receive cash milestone bonuses, not to exceed an aggregate amount of $200,000, of (1) $50,000 upon the Company’s completion of a financing, a strategic alliance ora merger or acquisition generating at least $2,500,000 of net proceeds (after commissions) during the term of that agreement, (2) $100,000 upon the Company’s completion of a financing, a strategic alliance or a merger or acquisitiongenerating at least $5,000,000 of net proceeds (after commissions) during the term of that agreement, or (3) $200,000 upon the Company’s completion of a

 

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financing, a strategic alliance or a merger or acquisition generating at least $10,000,000 of net proceeds (after commissions) during the term of that agreement. The 2009 Employment Agreementalso provided that an option granted to Dr. Singh to purchase 200,000 shares of the Company’s common stock would vest if the Company’s working capital is at least $8,000,000 at the end of the term of that agreement.

The 2010 Employment Agreement amends the 2009 Employment Agreement to provide that the milestones described in the preceding paragraphmay be satisfied by including the net proceeds received by the Company at any time prior to August 17, 2010 from (1) a financing by the Socius Capital Group or (2) any private placement financing that is covered by a signed term sheetthat was entered into by the Company prior to February 18, 2010 or from another source at the same or better terms as contemplated by such signed term sheet. Also, for purposes of determining whether the $8,000,000 working capital milestone inthe preceding paragraph has been satisfied, the 2010 Employment Agreement provides that working capital will be calculated as of the date of the Company’s receipt of the proceeds that are being included to satisfy the milestone.

Pursuant to the 2010 Employment Agreement, the Company granted to Dr. Singh a seven-year incentive stock option under theCompany’s 2006 Equity Incentive Plan, or a new qualified option plan, to purchase 600,000 shares of the Company’s common stock at an exercise price equal to $0.90 per share, which was the closing market price of the common stock on theoption grant date. The option grant is subject to the approval by the Company’s stockholders of an increase in the authorized number of shares under the Plan and an increase in the number of shares that may be granted to any individual during atwelve-month period. The option may be exercised during the period that Dr. Singh provides services to the Company and for 24 months after termination for any reason except termination for cause by the Company, provided that such exerciseis within the seven-year term of the option.

The option granted to Dr. Singh under the 2010 Employment Agreement willvest (1) as to 360,000 shares, in twelve equal monthly installments of 30,000 shares each over the twelve-month period from and immediately following the grant date, (2) as to 30,000 shares, if the Company achieves during theterm of the that agreement a volume-weighted average trading price for its common stock of greater than $1.60 for any consecutive 15-day trading period during the term of that agreement on average daily trading volume of at least 20,000 shares,(3) as to 90,000 shares, if the Company achieves during the term of that agreement a volume-weighted average trading price for its common stock of greater than $2.00 for any consecutive 15-day trading period during the term of thatagreement on average daily trading volume of at least 20,000 shares, (4) as to 30,000 shares, upon treating during the term of that agreement the first patient in a Phase II clinical trial, and (5) as to 90,000 shares, if during the termof the agreement the Company completes a financing, a strategic alliance or a licensing agreement with upfront licensing payments to the Company or a merger or acquisition that generates at least $5,000,000 of net proceeds (after commissions) forthe Company beyond the $10,000,000 achieved by August 17, 2010, with any financing proceeds received by the Company during the first six months of the 2010 Employment Agreement that are used to satisfy milestones under the 2009 EmploymentAgreement not being included as proceeds to satisfy the milestones described in this paragraph.

In the event that the Companyterminates the 2010 Employment Agreement without cause or does not extend the 2010 Employment Agreement upon its expiration for an additional one-year term, then (1) the Company upon such termination will be required to make a lump sum paymentto Dr. Singh equal to six months of his base annual salary, (2) any stock options granted to Dr. Singh, to the extent vested, will be retained by Dr. Singh and will be exercisable on the terms described above, and (3) thevesting of an additional number of shares subject to all options granted to Dr. Singh equal to 50% of all shares subject to such options that have not already vested will immediately accelerate and will be exercisable on the terms describedabove. If Dr. Singh terminates his employment for “good reason” as defined in the Employment Agreement, he will receive the severance benefits described in the preceding sentence, except that 100% of his options will vest if hisemployment terminates for good reason following a merger or similar corporate transaction in which the Company is not the surviving entity.

 

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James Bender, Ph.D.

Effective February 1, 2010, the Company entered into an Employment Agreement with Dr. James Bender pursuant to which Dr. Bender will serve on a full-time basis as the Company’s VicePresident – Product Development and Manufacturing for a one-year term commencing February 1, 2010. Prior to February 1, 2010, Dr. Bender had been serving on a part-time basis as the Company’s Vice President – ClinicalDevelopment pursuant to an Agreement dated as of September 1, 2009, as amended on September 14, 2009. Subsequent to January 31, 2011, Dr. Bender has continued to serve as the Company’s Vice President – ProductDevelopment and Manufacturing under the terms of the foregoing Employment Agreement pending the negotiation of a new employment agreement.

The Employment Agreement provides for an annual base salary of $170,000. Pursuant to the Employment Agreement, the Company granted to Dr. Bender a seven-year incentive stock option under theCompany’s 2006 Equity Incentive Plan to purchase 150,000 shares of the Company’s common stock at an exercise price equal to $0.90 per share, which was the closing market price of the common stock on the option grant date. The option grantis subject to the approval by the Company’s stockholders of an increase in the authorized number of shares under the Plan.

The option granted to Dr. Bender under the Employment Agreement will vest at the rate of 6,250 shares per month over the term of theEmployment Agreement as to 75,000 shares. The option will vest as to the remaining 75,000 shares upon the Company’s attainment of the following development milestones, and Dr. Bender will also be entitled to receive the following cashbonuses upon attainment of these milestones: (1) completion by September 30, 2010 of the technology transfer to a contract manufacturer for the Company’s ICT-107 product will result in a $10,000 cash bonus and the vesting of 25,000option shares; (2) completion by December 31, 2010 of FDA acceptance of a Phase II clinical trial plan for ICT-107 will result in a $10,000 cash bonus and the vesting of 25,000 option shares; and (3) completion by December 31,2010 of the enrollment of the first patient into the Phase II clinical trial for ICT-107 will result in a $10,000 bonus and the vesting of 25,000 option shares.

The Employment Agreement provides that all of the rights and obligations of the Company and Dr. Bender under his prior agreement to provide services to the Company (including Dr. Bender’sright to work for another organization) terminated as of January 31, 2010, except that Dr. Bender’s right under that agreement to receive cash bonuses and the vesting of options upon the Company’s achievement of specifieddevelopment milestones will remain in effect. The Employment Agreement provides that, except as described in the following sentence, if Dr. Bender’s employment terminates prior to the expiration of the one-year term, Dr. Bender willnot have any right to receive further compensation under the Employment Agreement other than compensation that was accrued as of his employment termination date. If the Company terminates Dr. Bender’s employment without “cause”as defined in the Employment Agreement, 50% of any unvested options held by Dr. Bender as of the employment termination date will vest, and he will also have the right to receive any compensation that was accrued as of the employmenttermination date.

C. Kirk Peacock

Effective October 30, 2008, the Company entered into an Employment Agreement with Mr. Peacock under which he continued to serve on a part-time basis as the Company’s Chief Financial Officerfor a one-year term. Under this agreement, Mr. Peacock received a monthly salary of $8,000 and was granted a seven-year non-qualified option to purchase 50,000 shares of the Company’s common stock at a price of $0.30 per share, with suchoption to vest in equal monthly installments over the one-year term of the agreement, with 50% of any then unvested option shares to become vested if Mr. Peacock’s employment was terminated by the Company without cause and with all vestedoptions to be exercisable for 24 months after termination of Mr. Peacock’s employment for any reason other than termination by the Company for cause.

 

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Effective October 30, 2009, the Company entered into a new Employment Agreement withMr. Peacock under which he will continue to serve on a part-time basis as the Company’s Chief Financial Officer for a one-year term. Under this agreement, Mr. Peacock receives a monthly salary of $6,000 and was granted a seven-yearnon-qualified option to purchase 56,000 shares of the Company’s common stock at a price of $0.80 per share, with 50,000 shares covered by such option to vest in equal monthly installments over the one-year term of the agreement and with 50% ofany those then unvested option shares to become vested if Mr. Peacock’s employment is terminated by the Company without cause.

Provided that by October 29, 2010, all of the Company’s internal documentation and internal testing necessary to subsequently complete the Company’s Sarbanes-Oxley Section 404 audithas been finished, the Company will pay Mr. Peacock an additional $6,000 and a further 6,000 of his option shares will become vested. Due to the elimination of the Sarbanes-Oxley Section 404 audit requirement for smaller issuers, thismilestone was not met.

Effective October 30, 2010, the Company renewed the Consulting Agreement with Mr. Peacockunder which he will continue to serve on a part-time basis as the Company’s Chief Financial Officer for five months. Under this agreement, Mr. Peacock receives a monthly salary of $8,000 and was granted 19,231 shares of restricted commonstock, with such shares to vest in equal monthly installments over the five-month term of the agreement and with 100% of any unearned compensation to become payable and any unvested option shares to become vested if Mr. Peacock’s servicesare terminated by the Company without cause.

David Fractor

The Company has entered into an agreement with David Fractor pursuant to which Mr. Fractor became the Company’s Chief Financial Officer effective as of April 4, 2011. Mr. Fractor willserve in this capacity on a part-time basis for a three-year term, subject to termination by either party on 30 days notice. Under this agreement, Mr. Fractor receives a monthly salary of $6,000 and was granted a seven-year option to purchase42,000 shares of the Company’s common stock at a price of $2.25 per share, with such option to vest in equal monthly installments over the three-year term of the agreement.

Indemnification of Directors and Officers

Our Amended and RestatedCertificate of Incorporation provides that, to the full extent permitted by the Delaware General Corporation Law, no director will be personally liable to us or our stockholders for or with respect to any acts or omissions in the performance of hisor her duties as a director.

Our Amended and Restated Certificate of Incorporation also provides that each person who is orwas or had agreed to become a director or officer, and each such person who is or was serving or who had agreed to serve at our request as a director, officer, employee, or agent of another corporation, partnership, joint venture, trust, or otherentity, will be indemnified by us to the full extent permitted by the Delaware General Corporation Law and will be entitled to advancement of expenses in connection therewith. Our Bylaws have similar indemnification provisions.

Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to our directors, officers andcontrolling persons pursuant to the foregoing provisions, or otherwise, we have been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

The following table sets forth certain information regarding beneficial ownership of our common stock as of March 1, 2011(a) by each person known by us to own beneficially 5% or more of any class of our common stock, (b) by each of our executive officers named in the Summary Compensation Table and our directors and (c) by all executive officers anddirectors of this company as a group. As of March 1, 2011, there were 28,725,624 shares of our common stock issued and outstanding. Unless otherwise noted, we believe that all persons named in the table have sole voting and investment powerwith respect to all the shares beneficially owned by them.

 

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Name and Address of Beneficial Owner(1)

  Shares
Beneficially
Owned(2)
  Percentage of
Class
 

John S. Yu, M.D.

   6,489,492(3)   18.43

Socius CG II, Ltd.

Socius Capital Group, LLC

Terren S. Peizer

Patricia Peizer

11150 Santa Monica Boulevard, Suite 1500 Los Angeles, CA 90025

   3,073,000(5)   9.99

Donald R. Scifres 2010 Annuity Trust R

One First Street, Ste. 14 Los Altos, CA 94022

   1,789,784(5)   6.09

Dr. Manish Singh

   1,725,223(7)   5.79

James Bender

   164,000(3)   *  

C. Kirk Peacock

   174,262(8)   *  

Jacqueline Brandwynne

   267,901(9)   *  

Richard A. Cowell

   195,801(10)   *  

Navdeep Jaikaria

   18,750(11)   *  

Rahul Singhvi

   26,932(12)   *  

All executive officers and directors as a group (8 persons)

   9,200,128    24.81

 

*Less than 1%.
(1)

Unless otherwise indicated, the address of each of the persons shown is c/o ImmunoCellular Therapeutics, Ltd., 21900 Burbank Boulevard, 3rd Floor, Woodland Hills, California 91367.

(2)Beneficial ownership is determined in accordance with the rules of the Securities and Exchange Commission and generally includes voting or investment power with respectto securities. Shares of common stock subject to options, warrants and convertible securities currently exercisable or convertible, or exercisable or convertible within 60 days after March 1, 2011, are deemed outstanding, including for purposesof computing the percentage ownership of the person holding such option, warrant or convertible security, but not for purposes of computing the percentage of any other holder.
(3)All of the shares shown are subject to options.
(4)Includes 5,000 shares of our restricted stock and 6,484,492 shares of our common stock issuable upon the exercise of stock options.
(5)Includes 1,025,000 shares owned of record and 2,048,000 shares subject to warrants. Socius CG II, Ltd. holds currently exercisable warrants to exercise up to 2,375,000shares, but the exercise of these warrants is limited by their terms so that beneficial ownership by Socius CG II, Ltd. shall not exceed at any time 9.99% of our common shares outstanding. The address of Socius CG II, Ltd. is Clarendon House, 2Church Street, Hamilton HM 11, Bermuda. The address of Socius Capital Group, LLC, Terren S. Peizer and Patricia Peizer is 11150 Santa Monica Boulevard, Suite 1500, Los Angeles, California 90025. Socius Capital Group, LLC, Mr. Peizer andMrs. Peizer each disclaims beneficial ownership of the securities described in the first sentence of this note 4, all of which are held of record by Socius CG II, Ltd. Information regarding the entities and individuals described in this note 4is based upon a Schedule 13G/A filed by such persons with the SEC on February 14, 2011.
(6)Includes 1,107,966 shares owned of record and 681,818 shares of our common stock issuable upon exercise of warrants.

 

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(7)Includes 663,839 shares owned of record and 1,061,384 shares of our common stock issuable upon exercise of options.
(8)Includes 80,031 shares owned of record, 19,231 shares of our restricted stock and 75,000 shares of our common stock issuable upon exercise of options.
(9)Includes 40,000 shares owned of record, 5,000 shares of our restricted stock and 222,901 shares of our common stock issuable upon exercise of options.
(10)Includes 5,000 shares of our restricted stock and 190,801 shares of our common stock issuable upon exercise of stock options.
(11)Includes 5,000 shares of our restricted stock and 13,750 shares of our common stock issuable upon exercise of stock options.
(12)Includes 8,182 shares owned of record, 5,000 shares of our restricted stock and 13,750 shares of our common stock issuable upon exercise of options.

SELLING SECURITYHOLDERS

Selling Securityholders Table

The shares to be offered by the selling securityholders are “restricted” securities under applicable federal and state securities laws and are being registered under the Securities Act, to givethe selling securityholders the opportunity to publicly sell these shares. The registration of these shares does not require that any of the shares be offered or sold by the selling securityholders. The selling securityholders may from time to timeoffer and sell all or a portion of their shares in the over-the-counter market, in negotiated transactions, or otherwise, at prices then prevailing or related to the then current market price or at negotiated prices.

The registered shares may be sold directly or through brokers or dealers, or in a distribution by one or more underwriters on a firmcommitment or best efforts basis. To the extent required, the names of any agent or broker-dealer and applicable commissions or discounts and any other required information with respect to any particular offer will be set forth in a prospectussupplement. Please see “Plan of Distribution.” The selling securityholders and any agents or broker-dealers that participate with the selling securityholders in the distribution of registered shares may be deemed to be“underwriters” within the meaning of the Securities Act, and any commissions received by them and any profit on the resale of the registered shares may be deemed to be underwriting commissions or discounts under the Securities Act.

No estimate can be given as to the amount or percentage of our common stock that will be held by the selling securityholdersafter any sales made pursuant to this prospectus because the selling securityholders are not required to sell any of the shares being registered under this prospectus. The following table assumes that the selling securityholders will sell all of theshares listed in this prospectus.

The following table sets forth the beneficial ownership of the selling securityholders. Theterm “selling securityholder” or “selling securityholders” includes the stockholders listed below and their respective transferees, assignees, pledges, donees or other successors. Beneficial ownership is determined in accordancewith the rules of the SEC and generally includes voting or investment power with respect to securities. Shares of common stock subject to options, warrants and convertible securities currently exercisable or convertible, or exercisable orconvertible within 60 days are deemed outstanding, including for purposes of computing the percentage ownership of the person holding the option, warrant or convertible security, but not for purposes of computing the percentage of any other holder.

 

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   Beneficial Ownership Before Offering  Beneficial
Ownership After
Offering(1)
 
   Number
of Shares
  Percent  Number of
Shares Being
Offered
  Number
of Shares
   Percent 

390 Partners, LP, 390 Partners Management Co., Inc., General Partner

   48,388 (2)   *    48,388 (2)   0     0  

ALB Private Investments LLC

   530,000 (3)   1.84  150,000 (3)   380,000     1.32

Asset Management Company Venture Fund L.P.

   241,936 (4)   *    241,936 (4)   0     0  

Auctus Private Equity Fund, LLC

   43,500 (5)   *    43,500 (5)   0     0  

Josiah & Valer Austin Family Rev Tr dtd 2/20/04

   97,500 (6)   *    97,500 (6)   0     0  

Jeffrey Benison

   97,500 (7)   *    97,500 (7)   0     0  

Brio Capital LP

   243,549 (8)   *    193,549 (8)   50,000     *  

David E. Burstein

   33,033 (9)   *    29,033 (9)   3,000     *  

Capital Ventures International

   1,356,000 (10)   4.65  1,356,000 (10)   0     0  

Anshu S. Chakrabortty & Sudip Chakrabortty JT TEN

   49,091 (11)   *    15,000 (11)   34,091     *  

Chestnut Ridge Partners, LP

   241,935 (12)   *    241,935 (12)   0     0  

The Conus Fund, L.P.

   208,350 (13)   *    124,350 (13)   84,000     *  

The Conus Fund Offshore Master Fund

   42,750 (14)   *    25,650 (14)   17,100     *  

Cummings Bay Healthcare Fund, LP

   241,936 (15)   *    241,936 (15)   0     0  

Cynergy Emerging Growth LLC

   48,388 (16)   *    48,388 (16)   0     0  

Cynergy Healthcare Investors, LLC

   48,388 (17)   *    48,388 (17)   0     0  

DAFNA Lifescience LTD

   60,900 (18)   *    60,900 (18)   0     0  

DAFNA Lifescience Market Neutral LTD

   54,000 (19)   *    54,000 (19)   0     0  

DAFNA Lifescience Select LTD

   127,200 (20)   *    127,200 (20)   0     0  

Dare To Be Great, LLC

   362,903 (21)   1.26  362,903 (21)   0     0  

Phyllis M. Esposito

   720,000 (22)   2.49  300,000 (22)   420,000     1.46

Jillian Gordon

   193,549 (23)   *    193,549 (23)   0     0  

Iguana Healthcare Master Fund, LTD

   512,500 (24)   1.78  412,500 (24)   100,000     0  

John Kellenyi

   97,500 (25)   *    97,500 (25)   0     0  

Klaus Kretschmer

   96,775 (26)   *    96,775 (26)   0     0  

Lincoln Park Capital Fund, LLC

   241,935 (27)   *    241,935 (27)   0     0  

Anthony Low-Beer

   1,300,000 (28)   4.48  300,000 (28)   1,000,000     3.48

Brendan S. MacMillan

   48,388 (29)   *    48,388 (29)   0     0  

Kevin McCormack

   50,000 (30)   *    15,000 (30)   35,000     *  

Ryan McCormack

   50,000 (31)   *    15,000 (31)   35,000     *  

JP Morgan Chase Bank as Custodian for Norman Schleifer Roth IRA

   58,300 (32)   *    48,300 (32)   10,000     *  

Norman Schleifer

   60,200 (33)   *    47,700 (33)   12,500     *  

Seamark Fund, LP

   541,936 (34)   1.87  241,936 (34)   300,000     1.04

Sneh Lata Singhal

   15,000 (35)   *    15,000 (35)   0     0  

Starlight Investment Holdings Limited

   96,775 (36)   *    96,775 (36)   0    

Stourbridge Investments LLC

   48,388 (37)   *    48,388 (37)   0     0  

Straus Healthcare Partners, L.P.

   725,807 (38)   2.51  725,807 (38)   0     0  

Straus Partners, L.P.

   725,807 (39)   2.51  725,807 (39)   0     0  

Stephen Taubenfeld

   26,250 (40)   *    26,250 (40)   0     0  

The Thunen Family Trust dated 10/4/05

   560,000 (41)   1.94  150,000 (41)   410,000     1.42

Weisbrod Family Office, LLC

   400,000 (42)   1.39  375,000 (42)   25,000     *  

Summer Street Research Partners

   101,804 (43)   *    101,804 (43)   0     0  

 

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   Beneficial Ownership Before Offering  Beneficial
Ownership After
Offering(1)
 
   Number
of Shares
  Percent   Number of
Shares Being
Offered
  Number
of Shares
   Percent 

Dawson James Securities, Inc.

   17,451 (44)   *     17,451 (44)   0     0  

Jonathan Blum

   20,361 (45)   *     20,361 (45)   0     0  

Brandon Ross

   20,361 (46)   *     20,361 (46)   0     0  

Scarsdale Equities LLC

   119,280 (47)   *     14,880 (47)   104,400     *  

Nickolay V. Kukekov

   33,934 (48)   *     33,934 (48)   0     0  

 

*Less than 1%
(1)Assumes the selling securityholder sells all of the shares of common stock included in this prospectus.
(2)Represents 32,258 shares of our common stock and 16,130 shares of our common stock issuable upon the exercise of warrants. Louis G. Lange III has voting andinvestment control over these securities.
(3)Represents 400,000 shares of our common stock and 130,000 shares of our common stock issuable upon the exercise of warrants, , which includes 100,000 shares of ourcommon stock and 50,000 shares of our common stock issuable upon the exercise of warrants included in this prospectus. Francis A. Mlynarczyk, Jr., Manager of ALB Private Investments LLC, has voting and investment power over the securities.
(4)Represents 161,290 shares of our common stock and 80,646 shares of our common stock issuable upon the exercise of warrants. David G. Fleshman has voting and investmentpower over these securities.
(5)Represents 29,000 shares of our common stock and 14,500 shares of our common stock issuable upon the exercise of warrants. Al Sollami has voting and investment powerover the securities.
(6)Represents 65,000 shares of our common stock and 32,500 shares of our common stock issuable upon the exercise of warrants.
(7)Represents 65,000 shares of our common stock and 32,500 shares of our common stock issuable upon the exercise of warrants.
(8)Represents 129,032 shares of our common stock and 114,517 shares of our common stock issuable upon the exercise of warrants, which includes 129,032 shares of our commonstock and 64,517 shares of our common stock issuable upon the exercise of warrants included in this prospectus. Shaye Hirsch is Managing Partner of Brio Capital L.P. and has voting and investment power over these securities.
(9)Represents 22,355 shares of our common stock and 9,678 shares of our common stock issuable upon the exercise of warrants, which includes 19,355 shares of our commonstock and 9,678 shares of our common stock issuable upon the exercise of warrants included in this prospectus.
(10)Represents 904,000 shares of our common stock and 452,000 shares of our common stock issuable upon the exercise of warrants. Heights Capital Management, Inc., theauthorized agent of Capital Ventures International (“CVI”), has discretionary authority to vote and dispose of the shares held by CVI and may be deemed to be the beneficial owner of these shares. Martin Kobinger, in his capacity asInvestment Manager of Heights Capital Management, Inc., may also be deemed to have investment discretion and voting power over the shares held by CVI. Mr. Kobinger disclaims any such beneficial ownership of the shares.
(11)Represents 32,727 shares of our common stock and 16,364 shares of our common stock issuable upon the exercise of warrants, which includes 10,000 shares of our commonstock and 5,000 shares of our common stock issuable upon the exercise of warrants included in this prospectus.

 

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(12)Represents 161,290 shares of our common stock and 80,645 shares of our common stock issuable upon the exercise of warrants. Kenneth Pasternak, CFO of Chestnut RidgePartners, LP, has voting and investment power over these securities.
(13)Represents 166,900 shares of our common stock and 41,450 shares of our common stock issuable upon the exercise of warrants, which includes 82,900 shares of our commonstock and 41,450 shares of our common stock issuable upon the exercise of warrants included in this prospectus. Andrew D. Zacks, Managing Member of Conus Capital LLC, general partner of The Conus Fund L.P., has voting and investment power over thesesecurities.
(14)Represents 34,200 shares of our common stock and 8,550 shares of our common stock issuable upon the exercise of warrants, which includes 17,100 shares of our commonstock and 8,550 shares of our common stock issuable upon the exercise of warrants included in this prospectus. Andrew D. Zacks, Managing Director and Investment Manager of Conus Partners, Inc., has voting and investment power over these securities.
(15)Represents 161,290 shares of our common stock and 80,646 shares of our common stock issuable upon the exercise of warrants. Michael Gregory, Portfolio Manager ofCummings Bay Healthcare Fund, LP, has voting and investment power over these securities.
(16)Represents 32,258 shares of our common stock and 16,130 shares of our common stock issuable upon the exercise of warrants. Patrick S. Adams, Managing Member of CynergyEmerging Growth LLC, has voting and investment power over these securities.
(17)Represents 32,258 shares of our common stock and 16,130 shares of our common stock issuable upon the exercise of warrants. Patrick S. Adams, Managing Member of CynergyHealthcare Investors LLC, has voting and investment power over these securities.
(18)Represents 40,600 shares of our common stock and 20,300 shares of our common stock issuable upon the exercise of warrants. Nathan Fischel, Managing Member of DAFNALifescience Ltd., has voting and investment power over these securities.
(19)Represents 36,000 shares of our common stock and 18,000 shares of our common stock issuable upon the exercise of warrants. Nathan Fischel, Managing Member of DAFNALifescience Market Neutral Ltd., has voting and investment power over these securities.
(20)Represents 84,800 shares of our common stock and 42,400 shares of our common stock issuable upon the exercise of warrants. Nathan Fischel, Managing Member of DAFNALifescience Select Ltd., has voting and investment power over these securities.
(21)Represents 241,935 shares of our common stock and 120,968 shares of our common stock issuable upon the exercise of warrants. Rainer Twiford, Managing Member of Dare tobe Great, LLC, has voting and investment power over these securities.
(22)Represents 500,000 shares of our common stock and 220,000 shares of our common stock issuable upon the exercise of warrants, which includes 200,000 shares of our commonstock and 100,000 shares of our common stock issuable upon the exercise of warrants included in this prospectus. Phylis Esposito has voting power and Phylis Esposito, Anthony Low-Beer and Scarsdale Equities LLC have investment power over thesecurities. Mr. Low-Beer and Scarsdale Equities LLC disclaim beneficial ownership of the securities.
(23)Represents 129,032 shares of our common stock and 64,517 shares of our common stock issuable upon the exercise of warrants.
(24)Represents 375,000 shares of our common stock and 137,500 shares of our common stock issuable upon the exercise of warrants, which includes 275,000 shares of our commonstock and 137,500 shares of our common stock issuable upon the exercise of warrants included in this prospectus. Stuart Weisbrod has voting and investment power over these securities.
(25)Represents 65,000 shares of our common stock and 32,500 shares of our common stock issuable upon the exercise of warrants.
(26)Represents 64,516 shares of our common stock and 32,259 shares of our common stock issuable upon the exercise of warrants.

 

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(27)Represents 161,290 shares of our common stock and 80,645 shares of our common stock issuable upon the exercise of warrants. Joshua Scheinfeld, through Rockledge CapitalCorporation and Jonathan Cope through Alex Noah Investors, Inc. are the managing members and have voting and investment power over these securities.
(28)Represents 1,000,000 shares of our common stock and 300,000 shares of our common stock issuable upon the exercise of warrants, which includes 200,000 shares of ourcommon stock and 100,000 shares of our common stock issuable upon exercise of warrants included in this prospectus.
(29)Represents 32,258 shares of our common stock and 16,130 shares of our common stock issuable upon the exercise of warrants.
(30)Represents 40,000 shares of our common stock and 10,000 shares of our common stock issuable upon the exercise of warrants, which includes 10,000 shares of our commonstock and 5,000 shares of our common stock issuable upon the exercise of warrants included in this prospectus. Kevin McCormack has voting power and Kevin McCormack, Anthony Low-Beer and Scarsdale Equities LLC have investment power over thesecurities. Mr. Low-Beer and Scarsdale Equities LLC disclaim beneficial ownership of the securities.
(31)Represents 40,000 shares of our common stock and 10,000 shares of our common stock issuable upon the exercise of warrants, which includes 10,000 shares of our commonstock and 5,000 shares of our common stock issuable upon the exercise of warrants included in this prospectus. Ryan McCormack has voting power and Ryan McCormack, Anthony Low-Beer and Scarsdale Equities LLC have investment power over the securities.Mr. Low-Beer and Scarsdale Equities LLC disclaim beneficial ownership of the securities.
(32)Represents 42,200 shares of our common stock and 16,100 shares of our common stock issuable upon the exercise of warrants, which includes 32,200 shares of our commonstock and 16,100 shares of our common stock issuable upon the exercise of warrants included in this prospectus.
(33)Represents 44,300 shares of our common stock and 15,900 shares of our common stock issuable upon the exercise of warrants, which includes 31,800 shares of our commonstock and 15,900 shares of our common stock issuable upon the exercise of warrants included in this prospectus.
(34)Represents 361,290 shares of our common stock and 180,646 shares of our common stock issuable upon the exercise of warrants, which includes 161,290 shares of our commonstock and 80,646 shares of our common stock issuable upon the exercise of warrants included in this prospectus. David T. Harrington and John D. Fraser, Managing Partners of Seamark Fund LP, have voting and investment power over these securities.
(35)Represents 10,000 shares of our common stock and 5,000 shares of our common stock issuable upon the exercise of warrants.
(36)Represents 64,516 shares of our common stock and 32,259 shares of our common stock issuable upon the exercise of warrants.
(37)Represents 32,258 shares of our common stock and 16,130 shares of our common stock issuable upon the exercise of warrants. Steve Schnipper, Managing Member ofStourbridge Investments LLC, has voting and investment power over these securities.
(38)Represents 483,871 shares of our common stock and 241,936 shares of our common stock issuable upon the exercise of warrants. Ravinder Holder has voting and investmentpower over these securities.
(39)Represents 483,871 shares of our common stock and 241,936 shares of our common stock issuable upon the exercise of warrants. Ravinder Holder has voting and investmentpower over these securities.
(40)Represents 17,500 shares of our common stock and 8,750 shares of our common stock issuable upon the exercise of warrants.

 

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(41)Represents 450,000 shares of our common stock and 110,000 shares of our common stock issuable upon the exercise of warrants, which includes 100,000 shares of our commonstock and 50,000 shares of our common stock issuable upon the exercise of warrants included in this prospectus. Garret G. Thunen and Carol Thunen, Trustees, have voting power and Garret G. Thunen, Carol Thunen, Anthony Low-Beer and ScarsdaleEquities LLC have investment power over the securities. Mr. Low-Beer and Scarsdale Equities LLC disclaim beneficial ownership of the securities
(42)Represents 275,000 shares of our common stock and 125,000 shares of our common stock issuable upon the exercise of warrants, which includes 250,000 shares of our commonstock and 125,000 shares of our common stock issuable upon the exercise of warrants included in this prospectus. Stuart Weisbrod, Chief Investment Officer for the Weisbrod Family Office, LLC, has voting and investment power over these securities.
(43)Represents 101,804 shares of our common stock issuable upon the exercise of warrants that we issued in consideration for services rendered as a placement agent in ourFebruary 2011 private placement. Al Sollami, President of Summer Street Research Partners, has voting and investment power over these securities.
(44)Represents 17,451 shares of our common stock issuable upon the exercise of warrants that we issued in consideration for services rendered as a placement agent in ourFebruary 2011 private placement. Albert Poliak, President of Dawson James Securities, Inc., has voting and investment power over these securities.
(45)Represents 20,361 shares of our common stock issuable upon the exercise of warrants that we issued in consideration for services rendered as a placement agent in ourFebruary 2011 private placement. The selling securityholder identified has indicated that he is, or is an affiliate of, Dawson James Securities, Inc., a registered broker-dealer.
(46)Represents 20,361 shares of our common stock issuable upon the exercise of warrants that we issued in consideration for services rendered as a placement agent in ourFebruary 2011 private placement. The selling securityholder identified has indicated that he is, or is an affiliate of, Dawson James Securities, Inc., a registered broker-dealer.
(47)Represents 119,280 shares of our common stock issuable upon the exercise of warrants, which includes 14,880 shares of our common stock issuable upon the exercise ofwarrants included in this prospectus that we issued in consideration for services rendered as a placement agent in our February 2011 private placement. Francis A. Mlynarczyk, Jr., Chief Executive Officer of Scarsdale Equities LLC has voting andinvestment power over these securities.
(48)Represents 33,934 shares of our common stock issuable upon the exercise of warrants that we issued in consideration for services rendered as a placement agent in ourFebruary 2011 private placement.

The information in the above table is as of the date of this prospectus.Information concerning the selling securityholders may change from time to time and any such changed information will be described in supplements to this prospectus if and when necessary.

The information in the above table is as of the date of this prospectus. Information concerning the selling securityholders may changefrom time to time and any such changed information will be described in supplements to this prospectus if and when necessary.

Relationships with Selling Securityholders

The selling securityholders did not have any position, office, or other material relationship with us or any of our affiliates within the past three years, except that Sumner Street Research Partners andDawson James Securities, Inc. assisted us in identifying the investors in connection with our February 2011 private placement. These broker-dealers received warrants to purchase shares of our common stock and cash compensation for providing theseservices.

 

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PLAN OF DISTRIBUTION

We are registering the shares of common stock issued to the selling securityholders and issuable upon exercise of the warrants issued tothe selling securityholders to permit the resale of these shares of common stock by the holders of the shares of common stock and warrants from time to time after the date of this prospectus. We will not receive any of the proceeds from the sale bythe selling securityholders of the shares of common stock. We will bear all fees and expenses incident to our obligation to register the shares of common stock.

The selling securityholders may sell all or a portion of the shares of common stock beneficially owned by them and offered hereby from time to time directly or through one or more underwriters,broker-dealers or agents. If the shares of common stock are sold through underwriters or broker-dealers, the selling securityholders will be responsible for underwriting discounts or commissions or agent’s commissions. The shares of commonstock may be sold on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale, in the over-the-counter market or in transactions otherwise than on these exchanges or systems or in theover-the-counter market and in one or more transactions at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale, or at negotiated prices. These sales may be effected in transactions,which may involve crosses or block transactions. The selling securityholders may use any one or more of the following methods when selling shares:

 

  

ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

 

  

block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal tofacilitate the transaction;

 

  

purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

 

  

an exchange distribution in accordance with the rules of the applicable exchange;

 

  

privately negotiated transactions;

 

  

settlement of short sales entered into after the effective date of the registration statement of which this prospectus is a part;

 

  

broker-dealers may agree with the selling securityholders to sell a specified number of such shares at a stipulated price per share;

 

  

through the writing or settlement of options or other hedging transactions, whether such options are listed on an options exchange or otherwise;

 

  

a combination of any such methods of sale; and

 

  

any other method permitted pursuant to applicable law.

The selling securityholders also may resell all or a portion of the shares in open market transactions in reliance upon Rule 144 under the Securities Act, as permitted by that rule, or Section 4(1)under the Securities Act, if available, rather than under this prospectus, provided that they meet the criteria and conform to the requirements of those provisions.

Broker dealers engaged by the selling securityholders may arrange for other broker dealers to participate in sales. If the selling securityholders effect such transactions by selling shares of commonstock to or through underwriters, broker-dealers or agents, such underwriters, broker-dealers or agents may receive

 

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commissions in the form of discounts, concessions or commissions from the selling securityholders or commissions from purchasers of the shares of common stock for whom they may act as agent or towhom they may sell as principal. Such commissions will be in amounts to be negotiated, but, except as set forth in a supplement to this Prospectus, in the case of an agency transaction will not be in excess of a customary brokerage commission incompliance with FINRA Rule 2440; and in the case of a principal transaction a markup or markdown in compliance with FINRA IM-2440.

In connection with sales of the shares of common stock or otherwise, the selling securityholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turnengage in short sales of the shares of common stock in the course of hedging in positions they assume. The selling securityholders may also sell shares of common stock short and if such short sale shall take place after the date that theregistration statement, of which this prospectus forms a part, is declared effective by the Commission, the selling securityholders may deliver shares of common stock covered by this prospectus to close out short positions and to return borrowedshares in connection with such short sales. The selling securityholders may also loan or pledge shares of common stock to broker-dealers that in turn may sell such shares, to the extent permitted by applicable law. The selling securityholders mayalso enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of shares offeredby this prospectus, which shares such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction). Notwithstanding the foregoing, the selling securityholders have beenadvised that they may not use shares registered in this registration statement to cover short sales of our common stock made prior to the date the registration statement, of which this prospectus forms a part, has been declared effective by the SEC.

The selling securityholders may, from time to time, pledge or grant a security interest in some or all of the warrants orshares of common stock owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the shares of common stock from time to time pursuant to this prospectus or any amendmentto this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act, amending, if necessary, the list of selling securityholders to include the pledgee, transferee or other successors in interest as selling securityholdersunder this prospectus. The selling securityholders also may transfer and donate the shares of common stock in other circumstances in which case the transferees, donees, pledgees or other successors in interest will be the selling beneficial ownersfor purposes of this prospectus.

The selling securityholders and any broker-dealer or agents participating in thedistribution of the shares of common stock may be deemed to be “underwriters” within the meaning of Section 2(11) of the Securities Act in connection with such sales. In such event, any commissions paid, or any discounts orconcessions allowed to, any such broker-dealer or agent and any profit on the resale of the shares purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. Selling Securityholders who are“underwriters” within the meaning of Section 2(11) of the Securities Act will be subject to the applicable prospectus delivery requirements of the Securities Act including Rule 172 thereunder and may be subject to certain statutoryliabilities of, including but not limited to, Sections 11, 12 and 17 of the Securities Act and Rule 10b-5 under the Securities Exchange Act of 1934, as amended, or the Exchange Act.

Each selling securityholder has informed the Company that it is not a registered broker-dealer and does not have any written or oralagreement or understanding, directly or indirectly, with any person to distribute the common stock. Upon the Company being notified in writing by a selling securityholder that any material arrangement has been entered into with a broker-dealer forthe sale of common stock through a block trade, special offering, exchange distribution or secondary distribution or a purchase by a broker or dealer, a supplement to this prospectus will be filed, if required, pursuant to Rule 424(b) under theSecurities Act, disclosing (i) the name of each such selling securityholder and of the participating broker-dealer(s), (ii) the number of shares involved, (iii) the price at which such the shares of common stock were sold,(iv) the commissions paid or discounts or concessions allowed to such broker-dealer(s), where applicable, (v) that such

 

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broker-dealer(s) did not conduct any investigation to verify the information set out or incorporated by reference in this prospectus, and (vi) other facts material to the transaction. In noevent shall any broker-dealer receive fees, commissions and markups, which, in the aggregate, would exceed eight percent (8.0%).

Under the securities laws of some states, the shares of common stock may be sold in such states only through registered or licensed brokers or dealers. In addition, in some states the shares of commonstock may not be sold unless such shares have been registered or qualified for sale in such state or an exemption from registration or qualification is available and is complied with.

There can be no assurance that any selling securityholder will sell any or all of the shares of common stock registered pursuant to theshelf registration statement, of which this prospectus forms a part.

Each selling securityholder and any other personparticipating in such distribution will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including, without limitation, to the extent applicable, Regulation M of the Exchange Act, which may limit thetiming of purchases and sales of any of the shares of common stock by the selling securityholder and any other participating person. To the extent applicable, Regulation M may also restrict the ability of any person engaged in the distribution ofthe shares of common stock to engage in market-making activities with respect to the shares of common stock. All of the foregoing may affect the marketability of the shares of common stock and the ability of any person or entity to engage inmarket-making activities with respect to the shares of common stock.

We will pay all expenses of the registration of theshares of common stock pursuant to the registration rights agreement, including, without limitation, Securities and Exchange Commission filing fees and expenses of compliance with state securities or “blue sky” laws; provided, however,that each selling securityholder will pay all underwriting discounts and selling commissions, if any and any related legal expenses incurred by it. We will indemnify the selling securityholders against certain liabilities, including some liabilitiesunder the Securities Act, in accordance with the registration rights agreement, or the selling securityholders will be entitled to contribution. We may be indemnified by the selling securityholders against civil liabilities, including liabilitiesunder the Securities Act, that may arise from any written information furnished to us by the selling securityholders specifically for use in this prospectus, in accordance with the related registration rights agreements, or we may be entitled tocontribution.

DESCRIPTION OF SECURITIES

We are presently authorized to issue 74,000,000 shares of $.0001 par value common stock and 1,000,000 shares of $0.0001 par valuepreferred stock. As of the date of this prospectus, we had 28,725,624 shares of common stock issued and outstanding and no shares of preferred stock issued and outstanding.

Common Stock

The holders of our common stock are entitled to equaldividends and distributions per share with respect to the common stock when, as and if declared by the Board of Directors from funds legally available therefore. No holder of any shares of common stock has a preemptive right to subscribe for any ofour securities, nor are any common shares subject to redemption or convertible into other securities. Upon liquidation, dissolution or winding-up of our company, and after payment of creditors and preferred stockholders, if any, the assets will bedivided pro rata on a share-for-share basis among the holders of the shares of common stock. All shares of common stock now outstanding are fully paid, validly issued and non-assessable. Each share of our common stock is entitled to one vote withrespect to the election of any director or any other matter upon which stockholders are required or permitted to vote.

 

 

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For so long as Dr. Yu owns shares of our common stock or fully vested immediatelyexercisable options to purchase shares of our common stock totaling at least 2,000,000 shares, we have agreed to use commercially reasonable efforts to enable Dr. Yu to continue to serve on our Board of Directors. For so long as Dr. Yuowns shares of our common stock or fully vested immediately exercisable options to purchase shares of our common stock totaling at least 4,000,000 shares or at least 5,000,000 shares, we have agreed to use commercially reasonable efforts to enableDr. Yu and either one or two, respectively, of his designees to serve on our Board of Directors.

Preferred Stock

Under our articles of incorporation, the Board of Directors has the power, without further action by the holders of the common stock, todesignate the relative rights and preferences of the preferred stock, and to issue the preferred stock in one or more series as designated by the Board of Directors. The designation of rights and preferences could include preferences as toliquidation, redemption and conversion rights, voting rights, dividends or other preferences, any of which may be dilutive of the interest of the holders of the common stock or the preferred stock of any other series. The issuance of preferred stockmay have the effect of delaying or preventing a change in control of the company without further stockholder action and may adversely affect the rights and powers, including voting rights, of the holders of the common stock.

In December 2009, we created a class of Series A Preferred Stock in connection with our agreement with Socius Capital Group under whichwe have the right, subject to satisfying certain specified conditions, to require Socius Capital Group to purchase shares of this Series A Preferred Stock. This class has 2,000 shares of preferred stock authorized. In May 2010, we issued andsold 400 of these shares and redeemed 248.148 of these shares immediately following their issuance, leaving 151.852 of these shares still outstanding. In December 2010, we redeemed the remaining 151.852 of these shares. There are no other shares ofour preferred stock currently issued or outstanding. The voting rights, preferences as to dividends and liquidation, redemption provisions and other terms of the Series A Preferred Stock are set forth in a certificate of designations of preferences,rights and limitations that we filed with the Delaware Secretary of State, and that has been filed as an exhibit to the registration statement on Form S-1 which became effective with the Securities and Exchange Commission on January 22, 2010.

Shares Eligible For Future Sale

As of the date of this prospectus, we had 28,725,624 shares of common stock issued and outstanding. In addition to our shares of common stock covered by this prospectus 23,505,856 of these shares arefreely tradeable or may be publicly resold under currently effective registration statements or pursuant to Rule 144. In addition to the shares of common stock issuable upon exercise of warrants covered by this prospectus, another 16,448,117shares of our common stock issuable upon exercise of other currently exercisable options or warrants are eligible to be sold pursuant to currently effective registration statements.

Rule 144

In general, under Rule 144 as currently in effect, a person (or persons whose shares are aggregated) who has beneficially owned restrictedsecurities for at least six months, including persons who may be deemed our “affiliates,” as that term is defined under the Securities Act, would be entitled to sell such securities. Sales under Rule 144 are subject to the availability ofcurrent public information about the company. A person who has not been our affiliate at any time during the three months preceding a sale, and who has beneficially owned his shares for at least one year, would be entitled under Rule 144 to sellsuch shares without regard to any limitations under Rule 144.

As of the date of this prospectus, approximately 13,229,405 ofour outstanding shares of common stock were eligible for public resale under Rule 144. The sale, or availability for sale, of substantial amounts of common stock could, in the future, adversely affect the market price of the common stock andcould impair our ability to raise additional capital through the sale of our equity securities or debt financing. The future availability of Rule 144 to our holders of restricted securities would be conditioned on, among other factors, theavailability of certain public information concerning the company.

 

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Delaware Business Combination Statute

Section 203 of the Delaware General Corporation Law provides that, subject to exceptions set forth therein, an interested stockholderof a Delaware corporation shall not engage in any business combination, including mergers or consolidations or acquisitions of additional shares of the corporation, with the corporation for a three-year period following the date that suchstockholder becomes an interested stockholder unless:

 

  

prior to such date, the board of directors of the corporation approved either the business combination or the transaction which resulted in thestockholder becoming an interested stockholder,

 

  

upon consummation of the transaction which resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least85% of the voting stock of the corporation outstanding at the time the transaction commenced, other than statutorily excluded shares, or

 

  

on or subsequent to such date, the business combination is approved by the board of directors of the corporation and authorized at an annual or specialmeeting of the stockholders by the affirmative vote of at least 66-2/3% of the outstanding voting stock which is not owned by the interested stockholder.

Except as otherwise set forth in Section 203, an interested stockholder is defined to include:

 

  

any person that is the owner of 15% or more of the outstanding voting stock of the corporation, or is an affiliate or associate of the corporation andwas the owner of 15% or more of the outstanding voting stock of the corporation at any time within three years immediately prior to the date of determination, and

 

  

the affiliates and associates of any such person.

Section 203 may make it more difficult for a person who would be an interested stockholder to affect various business combinations with a corporation for a three-year period. We have not elected tobe exempt from the restrictions imposed under Section 203. The provisions of Section 203 may encourage persons interested in acquiring us to negotiate in advance with our board, since the stockholder approval requirement would be avoidedif a majority of the directors then in office approves either the business combination or the transaction which results in any such person becoming an interested stockholder. Such provisions also may have the effect of preventing changes in ourmanagement. It is possible that such provisions could make it more difficult to accomplish transactions, which our stockholders may otherwise deem to be in their best interests.

Transfer Agent

Our transfer agent currently is Computershare.

DISCLOSURE OF SEC POSITION ON INDEMNIFICATION

FOR SECURITIES ACT LIABILITIES

Our Certificate of Incorporation provides that no officer or director shall be personally liable to this corporation or our stockholders for monetary damages except as provided pursuant to Delaware law.Our Bylaws and Certificate of Incorporation also provide that we shall indemnify and hold harmless each person who serves at any time as a director, officer, employee or agent of the company from and against any and all claims, judgments andliabilities to which such person shall become subject by reason of the fact that he is or was a director, officer, employee or agent of the company and shall reimburse such person for all legal and

 

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other expenses reasonably incurred by him or her in connection with any such claim or liability. We also have the power to defend such person from all suits or claims in accord with the Delawarelaw. The rights accruing to any person under our Bylaws and Certificate of Incorporation do not exclude any other right to which any such person may lawfully be entitled, and we may indemnify or reimburse such person in any proper case, even thoughnot specifically provided for by the Bylaws and Certificate of Incorporation.

In the agreements that we entered into withDr. Manish Singh (our President and Chief Executive Officer), C. Kirk Peacock (our Chief Financial Officer), and Dr. James Bender (Vice President – Product Development and Manufacturing), we agreed to indemnify each of these officersfor all claims arising out of performance of his duties, other than those arising out of his breach of the agreement or his gross negligence or willful misconduct.

LEGAL MATTERS

TroyGould PC, Los Angeles,California, has rendered an opinion with respect to the validity of the shares of common stock covered by this prospectus. TroyGould PC owns 112,593 shares of common stock. Certain members, employees and of counsel of that firm beneficially own inthe aggregate 858,549 shares or options to acquire shares of our common stock. The beneficial ownership of our shares described above includes all options that may be exercised within 60 days from the date of this prospectus.

EXPERTS

Our financial statements as of December 31, 2010 and for the year then ended, and for the period from February 25, 2004 (inception) through December 31, 2010 included in this prospectus have beenaudited by Marcum LLP to the extent and for the periods indicated in their report thereon. Such financial statements have been included in this prospectus and registration statement in reliance upon the reports of Marcum LLP given on the authorityof such firm as experts in auditing and accounting.

Our financial statements as of December 31, 2009 and for the years endedDecember 31, 2008 and 2009, and for the period from February 25, 2004 (inception) through December 31, 2009 included in this prospectus have been audited by Stonefield Josephson, Inc. to the extent and for the periods indicated in their reportthereon. Such financial statements have been included in this prospectus and registration statement in reliance upon the reports of Stonefield Josephson, Inc. given on the authority of such firm as experts in auditing and accounting.

WHERE YOU CAN FIND MORE INFORMATION

We have filed with the Securities and Exchange Commission a registration statement on Form S-1 under the Securities Act for the commonstock offered under this prospectus. We are subject to the informational requirements of the Exchange Act, and file annual, quarterly and current reports and other information with the SEC. These reports and other information filed by ImmunoCellularTherapeutics, Ltd. can be inspected and copied at the Public Reference Room of the SEC at 100 F Street, N.E., Washington, D.C. 20549 on official business days. Information on the operation of the Public Reference Room can be obtained by callingthe SEC at 1-800-SEC-0330. The SEC also maintains a Web site at http://www.sec.gov that contains reports, information statements and other information concerning ImmunoCellular Therapeutics, Ltd. This prospectus does not contain all theinformation in the registration statement and its exhibits, which we have filed with the SEC under the Securities Act and to which reference is made. Statements contained in this prospectus as to the contents of any contract or other documentreferred to are not necessarily complete and in each instance, if such contract or document is filed as an exhibit, reference is made to the copy of such contract or other document filed as an exhibit to such registration statement, each statementbeing qualified in all respects by such reference. We intend to furnish our stockholders with annual reports containing financial statements audited by our independent registered public accounting firm.

 

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GLOSSARY OF TERMS

 

Antibody:

  any of a large body of proteins normally present in the body or produced in response to an antigen that it neutralizes, thus producing an immune response.

Antigen:

  any substance that when introduced into the body can stimulate the production of antibodies and combine specifically with them.

Cancer Stem Cell:

  cancer cells (found within tumors or hematological cancers) that possess characteristics associated with normal stem cells, specifically the ability to give rise to all celltypes found in a particular cancer sample.

Cellular differentiation:

  the process by which a cell becomes specialized in order to perform a specific function.

Cytokine:

  any of a class of immunoregulatory proteins (such as interleukin, tumor necrosis factor, and interferon) that are released by cells of the immune system and act as intercellularmediators in the generation of an immune response. Also called chemokine.

Dendritic cell:

  a highly specialized white blood cell found in the skin, mucosa and lymphoid tissues that initiates a primary immune response by activating lymphocytes and secretingcytokines.

DNA:

  a nucleic acid that carries the genetic information in the cell and is capable of self-replication and synthesis of RNA, which determines protein synthesis and the transmissionof genetic information.

Epitope:

  a localized region on the surface of an antigen that is capable of eliciting an immune response and of combining with a specific antibody to counter thatresponse.

Glioblastoma

multiforme (GBM):

  the most common and most aggressive type of primary brain tumor in humans

Immunogenic:

  capable of inducing an immune response.

Lymphocyte:

  any of various white blood cells, including B cells and T cells, that function in the body’s immune system by recognizing and deactivating antigens. B cells act bystimulating the production of antibodies. T cells contain receptors on their cell surfaces that are capable of recognizing and binding to specific antigens. Lymphocytes are found in the lymph nodes and spleen and circulate continuously in theblood and lymph.

Lysate:

  the cellular debris and fluid produced by the disintegration of a cell resulting from the destruction of its membrane by a chemical substance, especially an antibody orenzyme.

Peptide:

  a compound containing two or more amino acids in which the carboxyl group of one acid is linked to the amino group of the other

Stem cell:

  an unspecified cell that upon division replaces its own numbers and also gives rise to cells that differentiate further into one or more specialized cell type.

T cell:

  any of several closely related lymphocytes, developed in the thymus, which circulate in the blood and lymph and orchestrate the immune system’s response to infected ormalignant cells.

 

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ImmunoCellular Therapeutics, Ltd.

(a Development Stage Company)

Index to Financial Statements

 

    Page 

Financial Statements for the Year Ended December 31, 2010:

  

Report of Independent Registered Public Accounting Firm – Marcum LLP

   F-2  

Report of Independent Registered Public Accounting Firm – Stonefield Josephson,Inc.

   F-3  

Balance Sheets as of December 31, 2009 and 2010

   F-4  

Statements of Operations for each of the three fiscal years in the period ended December 31, 2010 and from February 25, 2004 (Inception) to December 31, 2010

   F-5  

Statements of Shareholders Equity (Deficit) from February 25, 2004 (Inception) to December 31, 2010

   F-6  

Statements of Cash Flows for each of the three years in the period ended December 31, 2010 and from February 25, 2004 (Inception) to December 31, 2010

   F-7  

Notes to Consolidated Financial Statements

   F-8  

 

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Report of Independent Registered Public Accounting Firm

To the Audit Committee of the

Board ofDirectors and Shareholders of ImmunoCellular Therapeutics, Ltd.

We have audited the accompanying balance sheet of ImmunoCellularTherapeutics, Ltd. (a development stage company) (the “Company”) as of December 31, 2010, and the related statements of operations, changes in shareholders’ equity (deficit) and cash flows for the year then ended, and for theperiod from February 25, 2004 (inception) to December 31, 2010. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on ouraudit. The accompanying financial statements of the Company for the period from February 25, 2004 (inception) to December 31, 2009 were not audited by us. Those statements were audited by other auditors whose report, dated March 29, 2010expressed an unqualified opinion on those statements and included an explanatory paragraph regarding the Company s ability to continue as a going concern. The financial statements for the period from February 25, 2004 (inception) to December31, 2009 reflect a net loss of $14,711,146. Our opinion, insofar as it relates to the amounts included for such prior periods as indicated in the accompanying financial statements for such periods from February 25, 2004 (inception) through December31, 2009, is based solely on the report of such other auditors.

We conducted our audit in accordance with the standards of the Public CompanyAccounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, norwere we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances,but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supportingthe amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides areasonable basis for our opinion.

In our opinion, based on our audit and the report of the other auditors, the financial statements referredto above present fairly, in all material respects, the financial position of ImmunoCellular Therapeutics, Ltd. (a development stage company) as of December 31, 2010 and the results of its operations and its cash flows for the year then endedand for the period from February 25, 2004 (inception) to December 31, 2010 in conformity with accounting principles generally accepted in the United States of America.

Marcum LLP

Los Angeles, California

March 31, 2011

 

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Report of Independent Registered Public Accounting Firm

To the Audit Committee of the

Board ofDirectors and Stockholders of ImmunoCellular Therapeutics, Ltd.

We have audited the accompanying balance sheet of ImmunoCellularTherapeutics, Ltd. (a development stage company) (the “Company”) as of December 31, 2009, and the related statements of operations, shareholders’ equity (deficit) and cash flows for the years ended December 31, 2009 and2008, and for the period from February 25, 2004 (inception) to December 31, 2009. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statementsbased on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (UnitedStates). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The company is not required to have, nor were we engaged to perform, anaudit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose ofexpressing an opinion on the effectiveness of the company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosuresin the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for ouropinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position ofImmunoCellular Therapeutics, Ltd. (a development stage company) as of December 31, 2009, and the results of its operations and its cash flows for the years ended December 31, 2009, and for the period from February 25, 2004 (inception)to December 31, 2009 in conformity with accounting principles generally accepted in the United States of America.

Stonefield Josephson,Inc.

Los Angeles, California

March 31, 2010

 

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ImmunoCellular Therapeutics, Ltd.

(A Development Stage Company)

Balance Sheets

 

   December 31,
2009
  December 31,
2010
 

Assets

   

Current assets:

   

Cash and cash equivalents

  $331,353   $5,319,776  

Short-term investments

   1,075,903    —    

Other assets

   21,903    24,033  
         

Total current assets

   1,429,159    5,343,809  

Fixed assets, net

   5,428    12,367  

Deferred financing costs

   30,282    —    

Other assets

   7,847    8,974  
         

Total assets

  $1,472,716   $5,365,150  
         

Liability and Shareholders’ Equity (Deficit)

   

Current liabilities:

   

Accounts payable

  $225,601   $171,065  

Accrued liabilities

   150,120    276,384  
         

Total current liabilities

   375,721    447,449  
         

Warrant liabilities

   —      2,581,871  
         

Commitments and contingencies (note 5)

   —      —    
         

Shareholders’ equity:

   

Preferred stock $0.0001 par value, 1,000,000 shares authorized; 0 shares outstanding as of December 31, 2009 andDecember 31, 2010

   —      —    

Common stock, $0.0001 par value; 74,000,000 shares authorized; 14,867,842 shares and 22,213,602 shares issued and outstanding asof December 31, 2009 and December 31, 2010, respectively

   1,487    2,221  

Additional paid in capital

   15,859,322    25,341,679  

Promissory note

   (52,668  (54,282

Deficit accumulated during the development stage

   (14,711,146  (22,953,788
         

Total shareholders’ equity

   1,096,995    2,335,830  
         

Total liabilities and shareholders’ equity

  $1,472,716   $5,365,150  
         

The accompanying notes are an integral part of these financial statements.

 

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ImmunoCellular Therapeutics, Ltd.

(A Development Stage Company)

Statements of Operations

 

   For the Year
Ended
December 31,
2008
  For the Year
Ended
December 31,
2009
  For the Year
Ended
December 31,
2010
  February 25,
2004
(Inception) to
December 31,
2010
 

Revenues

  $ —     $300,000   $ —     $300,000  

Expenses:

     

Research and development

   1,296,772    962,526    2,292,630    5,560,267  

Merger costs

   —      —      —      73,977  

Stock-based compensation

   513,357    308,303    807,853    7,029,872  

General and administrative

   1,366,146    1,677,421    2,035,526    6,544,723  
                 

Total expenses

   3,176,275    2,948,250    5,136,009    19,208,839  
                 

Loss before other income and income taxes

   (3,176,275  (2,648,250  (5,136,009  (18,908,839

Other income:

     

Interest income

   116,545    22,045    4,105    334,789  

Change in fair value of warrant liability

   —      —      (1,018,238  (2,287,238
                 
   (3,059,730  (2,626,205  (6,150,142  (20,861,288

Income taxes

   —      —      —      —    
                 

Net loss

   (3,059,730  (2,626,205  (6,150,142  (20,861,288

Deemed dividend on redemption of preferred stock

   —      —      2,092,500    2,092,500  
                 

Net loss attributable to common stock

  $(3,059,730 $(2,626,205 $(8,242,642 $(22,953,788
                 

Weighted average number of common shares:

     

Basic and diluted

   12,540,301    13,719,991    19,188,541    11,295,755  
                 

Earnings (loss) per common share:

     

Basic and diluted

  $(0.24 $(0.19 $(0.43 $(2.03
                 

The accompanying notes are an integral part of these financial statements.

 

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ImmunoCellular Therapeutics, Ltd.

(A Development Stage Company)

Statements of Shareholders’ Equity (Deficit)

 

   Preferred Stock   Common Stock  Additional
Paid-In
  Promissory  Deficit
Accumulated
During the
Development
  Total 
  Shares  Amount   Shares  Amount  Capital  Note  Stage  

Initial capitalization at $0.00002 per share

   —     $—       6,256,500   $10   $87   $ —     $ —     $97  

Common stock issued for cash during 2004 at $0.00078 per share

   —      —       193,500    15    135    —      —      150  

Net loss

   —      —       —      —      —      —      (11,741  (11,741
                                  

Balance at December 31, 2004

   —      —       6,450,000    25    222    —      (11,741  (11,494

Common stock issued for cash during 2005 at $0.19 per share

   —      —       387,000    659    74,341    —      —      75,000  

Common stock issued for cash during 2005 at $0.32 per share

   —      —       154,800    16    49,984    —      —      50,000  

Common stock issued for research and development during 2005 at $0.99 per share

   —      —       154,800    15    152,745    —      —      152,760  

Net loss

   —      —       —      —      —      —      (246,004  (246,004
                                  

Balance at December 31, 2005

   —      —       7,146,600    715    277,292    —      (257,745  20,262  

Common stock issued for services during 2006 at $0.50 per share

   —      —       73,093    7    36,539    —      —      36,546  

Common stock issued for cash during 2006 in private placements at $1.00 per share, net of redemptions

   —      —       1,510,000    151    549,249    —      —      549,400  

Common stock issued for research and development during 2006 at $1.00 per share

   —      —       694,000    69    693,931    —      —      694,000  

Shares issued in connection with reverse merger

   —      —       825,124    83    (83  —      —      —    

Shares cancelled in connection with the sale of Optical Molecular Imaging, Inc.

   —      —       (2,059,100  (206  (64,794  —      —      (65,000

Exercise of stock options

   —      —       10,062    1    3,521    —      —      3,522  

Stock based compensation (options)

   —      —       —      —      4,103,645    —      —      4,103,645  

Net loss

   —      —       —      —      —      —      (5,152,713  (5,152,713
                                  

Balance at December 31, 2006

   —      —       8,199,779    820    5,599,300    —      (5,410,458  189,662  

Common stock issued for cash during 2007 in private placements at $1.50 per share

   —      —       3,531,603    353    4,892,133    —      —      4,892,486  

Exercise of stock options

   —      —       51,111    5    (5  —      —      —    

Reclassification of warrant derivative liability

   —      —       —      —      2,233,600    —      —      2,233,600  

Stock based compensation (options)

   —      —       —      —      1,296,714    —      —      1,296,714  

Net loss

   —      —       —      —      —      —      (3,614,753  (3,614,753
                                  

Balance at December 31, 2007

   —      —       11,782,493    1,178    14,021,742    —      (9,025,211  4,997,709  

Common stock issued for research and development during 2008 at $0.53 per share

   —      —       800,000    80    423,920    —      —      424,000  

Common stock issued for research and development during 2008 at $0.65 per share

   —      —       100,000    10    64,990    —      —      65,000  

Stock based compensation (options)

   —      —       —      —      513,357    —      —      513,357  

Net loss

   —      —       —      —      —      —      (3,059,730  (3,059,730
                                  

Balance at December 31, 2008

   —      —       12,682,493    1,268    15,024,009    —      (12,084,941  2,940,336  

Exercise of warrants

   —      —       1,970,992    1,97    462,551    —      —      462,748  

Exercise of stock options

   —      —       214,357    22    64,460    (52,668  —      11,814  

Stock based compensation (options)

   —      —       —      —      308,302    —      —      308,302  

Net loss

   —      —       —      —      —      —      (2,626,205  (2,626,205
                                  

Balance at December 31, 2009

   —      —       14,867,842    1,487    15,859,322    (52,668  (14,711,146  1,096,995  

Common stock and warrants issued for cash during 2010 at $1.00 per share, net of offering costs

   —      —       4,230,910    423    3,248,315    —      —      3,248,738  

Preferred stock and warrants issued for cash during 2010 at $10,000 per share, net of offering costs

   400    —       —      —      —      —      —      —    

Exercise of warrants in exchange for promissory note

   —      —       2,700,000    270    5,399,730    (5,400,000  —      —    

Redemption of preferred stock for repayment of promissory note

   (400  —       —      —      —      5,400,000    (2,092,500  3,307,500  

Exercise of stock options

   —      —       50,000    5    26,495    —      —      26,500  

Cashless exercise of stock options

   —      —       297,156    30    (30  —      —      —    

Common stock issued for services during 2010 at $0.90 per share

   —      —       60,000    6    53,994    —      —      54,000  

Common stock issued for services during 2010 at $1.06 per share

   —      —       7,694    —      8,156    —      —      8,156  

Stock based compensation

   —      —       —      —      745,697    —      —      745,697  

Interest on promissory note

   —      —       —      —      —      (1,614  —      (1,614

Net loss

   —      —       —      —      —      —      (6,150,142  (6,150,142
                                  

Balance at December 31, 2010

   —     $—       22,213,602   $2,221   $25,341,679   $(54,282 $(22,953,788 $2,335,830  
                                  

The accompanying notes are an integral part of these financial statements.

 

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ImmunoCellular Therapeutics, Ltd.

(A Development Stage Company)

Statements of Cash Flows

 

   For the Year
Ended
December 31,
2008
  For the Year
Ended
December 31,
2009
  For the Year
Ended
December 31,
2010
  February 25,
2004
(Inception) to
December 31,
2010
 

Cash flows from operating activities:

     

Net loss

  $(3,059,730 $(2,626,205 $(6,150,142 $(20,861,288

Adjustments to reconcile net loss to net cash used in operating activities:

     

Depreciation and amortization

   2,075    3,397    3,633    9,105  

Interest accrued on promissory note

   —      —      (1,264  (1,264

Change in fair value of warrant liability

   —      —      1,018,238    2,287,238  

Stock based compensation

   513,357    308,303    745,697    6,967,716  

Common stock issued for services

   —      —      62,156    98,703  

Common stock issued for research and development

   489,000    —      —      1,335,760  

Changes in assets and liabilities:

     

Other assets

   (5,440  (24,951  (3,256  (63,288

Accounts payable

   102,753    92,652    (54,536  171,065  

Accrued liabilities

   12,538    95,023    126,264    276,384  
                 

Net cash used in operating activities:

   (1,945,447  (2,151,781  (4,253,560  (9,780,219
                 

Cash flows from investing activities:

     

Sale (purchase) of short-term investments, net

   (3,000,000  1,924,097    1,075,903    —    

Purchase of property and equipment

   (10,087  (813  (10,572  (61,472

Cash paid for sale of OMI

   —      —      —      (25,000
                 

Net cash provided by (used in) investing activities:

   (3,010,087  1,923,284    1,065,331    (86,472
                 

Cash flows from financing activities:

     

Exercise of stock options

   —      11,812    26,500    41,834  

Exercise of warrant

   —      462,748    —      462,748  

Proceeds from issuance of common stock under private placement, net of offering costs

   —      —      4,370,994    10,777,480  

Proceeds from issuance of preferred stock under private placement, net of offering costs

   —      —      3,779,158    3,779,158  

Proceeds from issuance of common stock

   —      —      —      125,247  
                 

Net cash provided by financing activities

   —      474,560    8,176,652    15,186,467  
                 

Increase in cash and cash equivalents

   4,955,534    246,063    4,988,423    5,319,776  

Cash and cash equivalents at beginning of period

   (5,040,824  85,290    331,353    —    
                 

Cash and cash equivalents at end of period

  $85,290   $331,353   $5,319,776   $5,319,776  
                 

Supplemental cash flows disclosures:

     

Interest expense paid

  $—     $—     $—     $—    
                 

Income taxes paid

  $—     $—     $—     $—    
                 

The accompanying notes are an integral part of these financial statements.

 

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ImmunoCellular Therapeutics, Ltd.

(A Development Stage Company)

Notes to Financial Statements

1. Nature of Organization and Development StageOperations

ImmunoCellular Therapeutics, Ltd. (the Company) is a development stage company that is seeking to develop and commercialize newtherapeutics to fight cancer using the immune system.

In February 2008, the Company entered into an Agreement with Molecular Discoveries LLC(“Molecular Discoveries”), covering the Company’s acquisition of certain monoclonal antibody related technology owned by Molecular Discoveries and completed the acquisition of the technology on that date. The Molecular Discoveriesagreement also was acknowledged and agreed to by Dr. Cohava Gelber, an inventor of the technology acquired by the Company under this agreement and an equity owner of Molecular Discoveries.

The technology acquired under the Molecular Discoveries agreement and now owned by the Company consists of (i) a platform technology referred to byMolecular Discoveries as DIAAD for the potentially rapid discovery of monoclonal antibodies to detect and treat cancer and other chronic diseases and (ii) certain monoclonal antibody candidates for the potential detection and treatment ofmultiple myeloma, small cell lung, pancreatic and ovarian cancers. The monoclonal antibodies are covered by issued patents and pending patent applications in the fields of multiple myeloma, small cell lung and ovarian cancers.

As provided in the Molecular Discoveries agreement, the consideration for the intellectual property and related assets comprising the technology acquiredby the Company consisted of (i) the issuance of 800,000 shares of the Company’s common stock to Molecular Discoveries and (ii) the reimbursement by the Company to Molecular Discoveries or its managing member of $250,000 of previouslyincurred patent expenses. Molecular Discoveries has agreed that it will not publicly resell more than 100,000 shares in any 90-day period.

Since the Company’s inception on February 25, 2004, the Company has been primarily engaged in the acquisition of certain intellectual property,together with development of its product candidates and the recent clinical testing activities for one of its vaccine product candidates, and has not generated any recurring revenues. As a result, the Company has incurred operating losses and, as ofDecember 31, 2010, the Company had an accumulated deficit of $22,953,788. The Company expects to incur significant research, development and administrative expenses before any of its products can be launched and recurring revenues generated.

2. Summary of Significant Accounting Policies

Development Stage Enterprise – We are a development stage enterprise as defined by Financial Accounting Standard Board’s Topic 915, “Accounting and Reporting by DevelopmentStage Enterprises.” We are devoting substantially all our present efforts to research and development. All losses accumulated since inception are considered part of our development stage activities.

Liquidity – As of December 31, 2010, we had working capital of $4,896,360, compared to working capital of $1,053,438 as of December31, 2009. The estimated cost of completing the development of either of our current vaccine product candidates and of obtaining all required regulatory approvals to market either of those product candidates is substantially greater than the amountof funds we currently have available. However, we believe that our existing cash balances, together with the $8 million in proceeds, before offering costs, from our February 2011 private placement and potential proceeds under our preferred stockpurchase arrangement with Socius Capital Group, LLC, will be sufficient to fund our currently planned level of operations through at least the third quarter of 2012, although there is no assurance that such proceeds will be sufficient for thispurpose.

Cash and cash equivalents – The Company considers all highly liquid debt instruments with an original maturity of 90days or less to be cash equivalents. As of December 31, 2009 and December 31, 2010, the Company had $0 and $4,500,000, respectively, of certificates of deposit with an original maturity of 90 days or less. These securities were fullycovered by FDIC insurance.

Short-Term Investments – As of December 31, 2009 and December 31, 2010, the Company had$1,075,903 and $0, respectively, of certificates of deposit which mature within an original maturity of six months. These securities were fully covered by FDIC insurance. They are classified as held-to-maturity and under ASC Topic 320,“Investments in Debt Securities,” are measured at cost since the Company has the intent and ability to hold these securities to maturity.

Property and Equipment – Property and equipment are stated at cost and depreciated using the straight-line methods based on the estimated useful lives (generally three to five years) of therelated assets. Computer and computer equipment are depreciated over 3 years. Management continuously monitors and

 

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evaluates the realizability of recorded long-lived assets to determine whether their carrying values have been impaired. The Company records impairment losses on long-lived assets used inoperations when events and circumstances indicate that the assets might be impaired and the nondiscounted cash flows estimated to be generated by those assets are less than the carrying amount of those assets. Any impairment loss is measured bycomparing the fair value of the asset to its carrying amount. Repairs and maintenance costs are expensed as incurred.

Research andDevelopment Costs – Research and development expenses consist of costs incurred for direct research and development and are expensed as incurred. On November 10, 2010, the Company received a grant under the Patent Protection andAffordable Care Act of 2010. The grant, which totaled $244,479, will be used to fund ongoing projects, including the continued development of ICT-107 and was recorded as an offset to research and development costs for fiscal year endDecember 31, 2010.

Stock Based Compensation – Stock-based compensation expense is estimated as of the grant date based onthe fair value of the award. The Company uses the Black-Scholes option pricing model to estimate the fair value of stock options and quoted market prices of our common stock to estimate fair value of restricted stock. The expected term is estimatedusing the simplified method, as defined in Staff Accounting Bulletin No. 107. The risk free interest rate for each grant is equal to the U.S. Treasury rate in effect at the time of grant for instruments with an expected life similar to theexpected option term. Because of our limited trading history as a public company, the stock volatility assumption is based on an analysis of our historical volatility and the volatility of the common stock of comparable companies in the medicalindustry and on the historical volatility of our stock. The dividend yield of zero is based upon the fact that we have not historically granted cash dividends, and do not expect to issue dividends in the foreseeable future.

The Company recognizes stock-based compensation expense over the requisite service period, which generally equals the vesting period. For awards thatvest based on employment, the Company recognizes the associated compensation expense on a straight-line basis. For performance based awards, the Company recognizes expense using the graded vesting methodology based on the number of shares expectedto vest. Compensation expense associated with these performance based awards is adjusted quarterly to reflect subsequent changes in the estimated outcome of performance-related conditions until the date the results are determined.

Fair value was estimated at the date of grant using the Black-Scholes pricing model, with the following weighted average assumptions:

 

   Year Ended
December 31,
2008
  Year Ended
December 31,
2009
  Year Ended
December 31,
2010
 

Risk-free interest rate

   2.65  1.40  1.24

Expected dividend yield

   None    None    None  

Expected term

   3.9 years    3.8 years    3.7 years  

Expected volatility

   100.0  118.0  102.0

The weighted-average grant-date fair valueof options granted during the years ended December 31, 2008, 2009 and 2010 was $0.35, $0.32 and $0.62, respectively.

The risk-freeinterest rate used in the Black-Scholes valuation method is based on the implied yield currently available in U.S. Treasury securities at maturity with an equivalent term. The Company has not declared or paid any dividends and does not currentlyexpect to do so in the future. The expected term of options represents the period that our stock-based awards are expected to be outstanding and was determined based on projected holding periods for the remaining unexercised shares. Considerationwas given to the contractual terms of our stock-based awards, vesting schedules and expectations of future employee behavior.

 

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Expected volatility is based on market prices of traded options for comparable entities within our industry and on the historical volatility of our stock.

The Company’s stock price volatility and option lives involve management’s best estimates, both of which impact the fair value of the optioncalculated under the Black-Scholes methodology and, ultimately, the expense that will be recognized over the life of the option.

When optionsare exercised, our policy is to issue previously unissued shares of common stock to satisfy share option exercises. As of December 31, 2010, the Company had 51.8 million shares of authorized but unissued common stock.

No tax benefits were attributed to the stock-based compensation expense because a valuation allowance was maintained for substantially all net deferredtax assets.

Income Taxes – The Company accounts for federal and state income taxes in accordance with ASC Topic 740,“Accounting for Income Taxes”. Under the liability method, a deferred tax asset or liability is determined based on the difference between the financial statement and tax basis of assets and liabilities, as measured by the enacted taxrates. The Company’s provision for income taxes represents the amount of taxes currently payable, if any, plus the change in the amount of net deferred tax assets or liabilities. A valuation allowance is provided against net deferred tax assetsif recoverability is uncertain on a more likely than not basis. FASB ASC 740, Income Taxes, (“ASC 740”), clarifies the accounting for uncertainty in income tax positions (“tax positions”). The provisions of ASC 740 requirethe Company to recognize in its financial statements the impact of a tax position if the position will more likely than not be sustained upon examination by a taxing authority, based on the technical merits of the position. The Company periodicallyanalyzes its tax positions taken and expected to be taken and has determined that since inception there has been no need to record a liability for uncertain tax positions. The Company recognizes interest and penalties for uncertain tax positions inincome tax expense. There was no accrued interest or penalties related to uncertain tax positions as of December 31, 2008, 2009 or 2010. The Company is neither under examination by any taxing authority, nor has it been notified of an impendingexamination. Due to the Company’s recognition of losses since inception, all of the Company’s reporting periods are effectively open to examination by the applicable taxing authorities.

Fair Value Measurements – The Company measures the fair value of financial assets and liabilities recorded at fair value based on theguidance of ASC 820, Fair Value Measurements and Disclosures (“ASC 820”) which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements.

ASC 820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal ormost advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs andminimize the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:

Level 1 - quoted prices in active markets for identical assets or liabilities

Level 2 - quoted prices for similar assets and liabilities in active markets or inputs that are observable

Level 3 - inputs that are unobservable (for example cash flow modeling inputs based on assumptions)

Warrant liabilities represent the only financial assets or liabilities recorded at fair value by the Company. The fair value of warrant liabilities aredetermined based on Level 3 inputs.

Use of Estimates – The preparation of financial statements in conformity with accountingprinciples generally accepted in the United States requires management to make certain estimates and assumptions about the future outcome of current transactions which may affect the reporting and disclosure of these transactions. Accordingly,actual results could differ from those estimates used in the preparation of these financial statements.

Basic and Diluted Loss per CommonShare – Basic and diluted loss per common share are computed based on the weighted average number of common shares outstanding. Common share equivalents (which consist of options and warrants) are excluded from the computation of dilutedloss per share since the effect would be antidilutive. Common share equivalents which could potentially dilute basic earnings per share in the future, and which were excluded from the computation of diluted loss per share, totaled 16,113,917 shares,10,555,927 shares and 12,358,018 shares at December 31, 2008, December 31, 2009 and December 31, 2010, respectively.

Recently Issued Accounting Standards – Effective January 1, 2010, the Company adopted an accounting standard update regarding fair valuemeasurements. As codified under ASC 820, this update

 

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requires additional disclosures about fair value measurements including transfers in and out of Levels 1 and 2 and a higher level of disaggregation for the different types of financialinstruments. For the reconciliation of Level 3 fair value measurements, information about purchases, sales, issuances and settlements should be presented separately. Because this update addresses disclosure requirements, the adoption of this updatedid not impact our financial position, results of operations or cash flows.

Reclassifications – Certain prior year items havebeen reclassified to conform to current year presentation.

3. Property and Equipment

As of December 31, 2009 and December 31, 2010, $10,900 and $21,472 of equipment had been purchased, respectively. Depreciation expense was$2,075, $3,397 and $3,633 for the years ended December 31, 2008, December 31, 2009 and December 31, 2010, respectively. Depreciation expense was $9,105 for the period from February 25, 2004 (date of inception) toDecember 31, 2010.

4. Related-Party Transactions

Cedars-Sinai Medical Center License Agreement

In November 2006, the Company entered into alicense agreement with Cedars-Sinai Medical Center (“Cedars-Sinai”) under which the Company acquired an exclusive, worldwide license to its technology for use as cellular therapies, including cancer stem cell and dendritic cell-basedvaccines for neurological disorders that include brain tumors and neurodegenerative disorders and other cancers. This technology is covered by a number of pending U.S. and foreign patent applications, and the term of the license will be until thelast to expire of any patents that are issued covering this technology.

As an upfront licensing fee, the Company issued Cedars-Sinai 694,000shares of its common stock and paid Cedars-Sinai $62,000. Additional specified milestone payments will be required to be paid to Cedars-Sinai when the Company initiates patient enrollment in its first Phase III clinical trial and when itreceives FDA marketing approval for its first product.

The Company has agreed to pay Cedars-Sinai specified percentages of all of itssublicensing income and gross revenues from sales of products based on the licensed technology, subject to a reduction if it must make any payments to any third party whose proprietary rights would be infringed by sale of the products. To maintainits rights to the licensed technology, the Company must meet certain development and funding milestones. These milestones include, among others, commencing a Phase I clinical trial for a product candidate by March 31, 2007 and raising atleast $5,000,000 in funding from equity or other sources by December 31, 2008. The Company satisfied the foregoing funding requirement in 2007 and commenced a Phase I clinical trial in May 2007, which was within the applicable cure period forthe milestone requirement. Through December 31, 2009, the Company has paid Cedars-Sinai a total of $166,660 in connection with the Phase I clinical trial. The Company also was required to commence a Phase II clinical trial for aproduct candidate by December 31, 2008 and a waiver of this requirement was obtained from Cedars-Sinai (see Second Amendment below).

OnJune 16, 2008, the Company entered into a First Amendment to Exclusive License Agreement (the “Amendment”) with Cedars-Sinai. The Amendment amended the License Agreement to include in the Company’s exclusive license fromCedars-Sinai under that agreement an epitope to CD133 and certain related intellectual property. This technology will be covered by a U.S. patent application that will be filed by the parties. Pursuant to the Amendment, the Company issuedCedars-Sinai 100,000 shares of the Company’s common stock as an additional license fee for the licensed CD133 epitope technology, which will be subject to the royalty and other terms of the License Agreement.

 

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On July 22, 2009, the Company entered into a Second Amendment to Exclusive License Agreement (the“Second Amendment”) with Cedars-Sinai to become effective August 1, 2009. The Second Amendment amended the License Agreement to revise the milestones set forth in the License Agreement that the Company must achieve in order tomaintain its license rights under that agreement. The revised milestones include the replacement of a milestone that required commencement of a Phase II clinical trial for the Company’s first product candidate by no later than December 31,2008 with milestones that require commencement of a Phase I clinical trial for the Company’s second product candidate by no later than June 30, 2010 and commencement of a Phase II clinical trial for one of the Company’s productcandidates by no later than March 31, 2012.

Effective March 23, 2010, the Company entered into a Third Amendment to the ExclusiveLicense Agreement (the “Third Amendment”) with Cedars-Sinai. The Third Amendment amended the License Agreement to revise the milestones set forth in the License Agreement that the Company must achieve in order to maintain its licenserights under that agreement. The revised milestones include the replacement of a milestone that required commencement of a Phase I clinical trial for the Company’s second product candidate by no later than June 30, 2010 and commencement ofa Phase II clinical trial for one of the Company’s product candidates by no later than March 31, 2012 with a requirement that the Company by September 30, 2011 either commence a Phase II clinical trial for its dendritic cellvaccine candidate or a Phase I clinical trial for its cancer stem cell vaccine candidate. The amendment also added a requirement that the Company obtain certain defined forms of equity or other funding in the amount of at least $2,500,000 byDecember 31, 2010 and a total of at least $5,000,000 by September 30, 2011. These funding requirements were fully satisfied as of June 30, 2010.

On September 20, 2010, the Company entered into a sponsored research agreement with Cedars-Sinai to provide services to develop standard operating procedures for dendritic cell vaccine preparationover the next twelve months for $446,142.

5. Commitments and Contingencies

Operating Lease

Effective March 1, 2010, the Company renewed its lease throughMarch 31, 2011 at a monthly rental rate of $2,779. In May 2010, the Company amended its lease to a monthly rental rate of $2,320 for three months and to a monthly rental rate of $2,894 for the remaining months through June 30, 2011. InAugust 2010, the Company amended its lease to a monthly rental rate of $3,140 for September 2010 and to a monthly rental rate of $3,493 for the remaining months through June 30, 2011.

Employment Agreement with Dr. Manish Singh

On March 4, 2010, the Company enteredinto an Employment Agreement, effective as of February 18, 2010, with Dr. Manish Singh pursuant to which Dr. Singh will continue to serve on a full-time basis as the Company’s President and Chief Executive Officer for a one-yearterm commencing February 18, 2010. The Company is required under the Employment Agreement to use its commercially reasonable efforts to have Dr. Singh continue to serve as a member of the Company’s Board of Directors during the termof the Employment Agreement. The Employment Agreement may be extended for an additional one-year period upon the mutual agreement of the Company and Dr. Singh.

The Employment Agreement provides for an annual base salary of $300,000. In addition, provided that Dr. Singh continues to serve as the Company’s President and Chief Executive Officer for theentire one-year term of the Employment Agreement, the Company will pay Dr. Singh a discretionary cash bonus of up to $50,000 upon completion of the one-year term.

The Employment Agreement dated as of February 18, 2009 between the Company and Dr. Singh (the “Prior Agreement”) provides that Dr. Singh is entitled to receive cash milestonebonuses, not to exceed an

 

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aggregate amount of $200,000, of (i) $50,000 upon the Company’s completion of a financing, a strategic alliance or a merger or acquisition generating at least $2,500,000 of net proceeds(after commissions) during the term of the Prior Agreement, (ii) $100,000 upon the Company’s completion of a financing, a strategic alliance or a merger or acquisition generating at least $5,000,000 of net proceeds (after commissions)during the term of the Prior Agreement, or (iii) $200,000 upon the Company’s completion of a financing, a strategic alliance or a merger or acquisition generating at least $10,000,000 of net proceeds (after commissions) during the term ofthe Prior Agreement. The Prior Agreement also provides that an option granted to Dr. Singh to purchase 200,000 shares of the Company’s common stock will vest if the Company’s working capital is at least $8,000,000 at the end of theterm of the Prior Agreement.

The Employment Agreement amends the Prior Agreement to provide that the milestones described in the precedingparagraph may be satisfied by including the net proceeds received by the Company at any time prior to August 17, 2010 from (i) a financing by the Socius Capital Group or (ii) any private placement financing that is covered by a signedterm sheet that was entered into by the Company prior to February 18, 2010 or from another source at the same or better terms as contemplated by such signed term sheet. Also, for purposes of determining whether the $8,000,000 working capitalmilestone in the preceding paragraph has been satisfied, the Employment Agreement provides that working capital will be calculated as of the date of the Company’s receipt of the proceeds that are being included to satisfy the milestone. Thisfunding milestone was fully satisfied as of June 30, 2010.

Pursuant to the Employment Agreement, the Company granted to Dr. Singh aseven-year incentive stock option under the Company’s 2006 Equity Incentive Plan (the “Plan”), or a new qualified option plan, to purchase 600,000 shares of the Company’s common stock at an exercise price equal to $0.90 pershare, which was the closing market price of the common stock on the option grant date. The option grant was subject to the approval by the Company’s stockholders of an increase in the authorized number of shares under the Plan and an increasein the number of shares that may be granted to any individual during a 12-month period, which approval was subsequently obtained. The option may be exercised during the period that Dr. Singh provides services to the Company and for 24 monthsafter termination for any reason except termination for cause by the Company, provided that such exercise is within the seven-year term of the option.

The option granted to Dr. Singh under the Employment Agreement will vest (i) as to 360,000 shares, in 12 equal monthly installments of 30,000 shares each over the 12-month period from andimmediately following the grant date, (ii) as to 30,000 shares, if the Company achieves during the term of the Employment Agreement a volume-weighted average trading price for its common stock of greater than $1.60 for any consecutive 15-daytrading period during the term of the agreement on average daily trading volume of at least 20,000 shares, (iii) as to 90,000 shares, if the Company achieves during the term of the Employment Agreement a volume-weighted average trading pricefor its common stock of greater than $2.00 for any consecutive 15-day trading period during the term of the agreement on average daily trading volume of at least 20,000 shares, (iv) as to 30,000 shares, upon treating the first patient in aPhase II clinical trial, and (v) as to 90,000 shares, if during the term of the Employment Agreement the Company completes a financing, a strategic alliance or a licensing agreement with upfront licensing payments to the Company or a merger oracquisition that generates at least $5,000,000 of net proceeds (after commissions) for the Company beyond the $10,000,000 achieved by August 17, 2010, with any financing proceeds received by the Company during the first 6 months of theEmployment Agreement that are used to satisfy milestones under the Prior Agreement not being included as proceeds to satisfy the milestones described in this paragraph.

In the event that the Company terminates the Employment Agreement without cause or does not extend the Employment Agreement upon its expiration for an additional one-year term, then (i) the Companyupon such termination will be required to make a lump sum payment to Dr. Singh equal to 6 months of his base annual salary, (ii) any stock options granted to Dr. Singh, to the extent vested, will be retained by Dr. Singh and willbe exercisable on the terms described above, and (iii) the vesting of an additional number of shares subject to all options granted to Dr. Singh equal to 50% of all shares subject to such options that have not already vested willimmediately accelerate and will be exercisable on the terms described above. If

 

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Dr. Singh terminates his employment for “good reason” as defined in the Employment Agreement, he will receive the severance benefits described in the preceding sentence, exceptthat 100% of his options will vest if his employment terminates for good reason following a merger or similar corporate transaction in which the Company is not the surviving entity.

Employment Agreement with Dr. James Bender

On March 4, 2010, the Company enteredinto an Employment Agreement, effective as of February 1, 2010, with Dr. James Bender pursuant to which Dr. Bender will serve on a full-time basis as the Company’s Vice President – Product Development and Manufacturing for aone-year term commencing February 18, 2010. Prior to February 1, 2010, Dr. Bender had been serving on a part-time basis as the Company’s Vice President – Clinical Development pursuant to an Agreement dated as ofSeptember 1, 2009, as amended on September 14, 2009 (the “Prior Agreement”).

The Employment Agreement provides for anannual base salary of $170,000. Pursuant to the Employment Agreement, the Company granted to Dr. Bender a seven-year incentive stock option under the Company’s Plan to purchase 150,000 shares of the Company’s common stock at anexercise price equal to $0.90 per share, which was the closing market price of the common stock on the option grant date. The option grant was subject to the approval by the Company’s stockholders of an increase in the authorized number ofshares under the Plan, which approval was subsequently obtained.

The option granted to Dr. Bender under the Employment Agreement willvest at the rate of 6,250 shares per month over the term of the Employment Agreement as to 75,000 shares. The option will vest as to the remaining 75,000 shares upon the Company’s attainment of the following development milestones, andDr. Bender will also be entitled to receive the following cash bonuses upon attainment of these milestones: (i) completion by September 30, 2010 of the technology transfer to a contract manufacturer for the Company’s ICT-107product will result in a $10,000 cash bonus and the vesting of 25,000 option shares; (ii) completion by December 31, 2010 of FDA acceptance of a Phase II clinical trial plan for ICT-107 will result in a $10,000 cash bonus and the vestingof 25,000 option shares; and (iii) completion by December 31, 2010 of the enrollment of the first patient into the Phase II clinical trial for ICT-107 will result in a $10,000 bonus and the vesting of 25,000 option shares.

The Employment Agreement provides that all of the rights and obligations of the Company and Dr. Bender under the Prior Agreement (includingDr. Bender’s right to work for another organization) terminated as of January 31, 2010, except that Dr. Bender’s right under the Prior Agreement to receive cash bonuses and the vesting of options upon the Company’sachievement of specified development milestones will remain in effect.

The Employment Agreement provides that, except as described in thefollowing sentence, if Dr. Bender’s employment terminates prior to the expiration of the one-year term, Dr. Bender will not have any right to receive further compensation under the Employment Agreement other than compensation that wasaccrued as of his employment termination date. If the Company terminates Dr. Bender’s employment without “cause” as defined in the Employment Agreement, 50% of any unvested options held by Dr. Bender as of the employmenttermination date will vest, and he will also have the right to receive any compensation that was accrued as of the employment termination date.

Agreement with Dr. John Yu

Effective March 1, 2010, the Company entered into an Agreement with Dr. Yu under which he agreed to serve on a part-time basis as theCompany’s Chief Scientific Officer for a one-year term. The Agreement provides for an annual base salary of $70,000 and for cash bonuses of $15,000 each if prior to December 31, 2010 (i) the FDA has accepted a Phase II clinicaltrial plan for ICT-107, and (ii) a Physicians Investigator IND submission for one of the Company’s specified product candidates has been accepted by the FDA.

 

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Pursuant to the Agreement, the Company granted to Dr. Yu a seven-year nonqualified stock option underthe Company’s 2006 Equity Incentive Plan to purchase 125,000 shares of the Company’s common stock at an exercise price equal to $0.90 per share, which was the closing market price of the common stock on the option grant date. The optiongrant was subject to the approval by the Company’s stockholders of an increase in the authorized number of shares under the Plan, which approval was subsequently obtained. The option may be exercised during the period that Dr. Yu providesservices to the Company and for 24 months after termination for any reason except termination for cause by the Company, provided that such exercise is within the seven-year term of the option.

The option granted to Dr. Yu under the Agreement will vest (i) as to 75,000 shares in four equal quarterly installments following the date ofgrant and (ii) as to the remaining 50,000 shares, 25,000 shares shall each vest upon timely satisfying the two milestones described above for the payment of cash bonuses to Dr. Yu.

Agreement with C. Kirk Peacock

Effective as of October 30, 2008, the Company renewed,under similar terms, the consulting agreement with C. Kirk Peacock under which Mr. Peacock agreed to serve as Chief Financial Officer for a one-year term, subject to earlier termination by the Company or Mr. Peacock on 30 days notice.Mr. Peacock will provide his services to the Company on a part-time basis. Under the agreement with Mr. Peacock, Mr. Peacock will be paid $8,000 per month and was granted an option to purchase 50,000 shares of common stock, which willvest monthly over a one-year period, and exercisable within its term during the period Mr. Peacock provides services to the Company and for 24 months after the grantee ceases providing services for any reason other than termination by theCompany for cause. Effective May 2009, the consulting agreement dated October 30, 2008 with C. Kirk Peacock was amended to reduce the amount to be paid to $6,000 per month. No other terms of the agreement were changed.

Effective October 30, 2009, the Company renewed the Consulting Agreement with Mr. Peacock under which he will continue to serve on a part-timebasis as the Company’s Chief Financial Officer for a one-year term. Under this agreement, Mr. Peacock receives a monthly salary of $6,000 and was granted a seven-year non-qualified option to purchase 56,000 shares of the Company’scommon stock at a price of $0.80 per share, with 50,000 shares covered by such option to vest in equal monthly installments over the one-year term of the agreement and with 50% of any those then unvested option shares to become vested ifMr. Peacock’s services are terminated by the Company without cause.

Provided that by October 29, 2010, all of theCompany’s internal documentation and internal testing necessary to subsequently complete the Company’s Sarbanes-Oxley Section 404 audit has been finished, the Company will pay Mr. Peacock an additional $6,000 and a further 6,000of his option shares will become vested. Due to the elimination of the Sarbanes-Oxley Section 404 audit requirement for smaller issuers, this milestone was not met.

Effective October 30, 2010, the Company renewed the Consulting Agreement with Mr. Peacock under which he will continue to serve on a part-time basis as the Company’s Chief Financial Officerfor five months. Under this agreement, Mr. Peacock receives a monthly salary of $8,000 and was granted 19,231 shares of restricted common stock, with such shares to vest in equal monthly installments over the five-month term of the agreementand with 100% of any unearned compensation to become payable and any unvested option shares to become vested if Mr. Peacock’s services are terminated by the Company without cause.

Agreements for Financial Advisory Services

On October 1, 2010, the Company enteredinto an agreement with JFS Investments to provide certain financial advisory services to the Company on a non-exclusive basis (the “JFS Agreement”). The Company will issue an aggregate of up to 144,000 shares of the Company’s commonstock as follows: 24,000 shares to

 

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JFS Investments and 12,000 shares to Samel, LLC upon the signing of the JFS Agreement and 108,000 shares to be issued at the rate of 8,000 shares to JFS Investments and 4,000 shares to Samel, LLCeach month for months four through twelve following the signing of the JFS Agreement if the Agreement is in effect and has not been terminated by the Company as of that time. Pursuant to the JFS Agreement, the Company also granted three-yearwarrants to purchase 80,000 shares of the Company’s common stock at an exercise price of $1.00 per share to JFS Investments to vest as to 20,000 shares upon issuance and 6,667 shares on the first day of each of the fourth through the eleventhmonths and 6,664 shares in the twelfth month and 40,000 shares to Samel, LLC to vest as to 10,000 shares upon issuance and 3,333 shares on the first day of each of the fourth through the eleventh months and 3,336 shares in the twelfth month.Pursuant to the JFS Agreement, the Company also granted three-year warrants to purchase 80,000 shares of the Company’s common stock at an exercise price of $2.00 per share to JFS Investments to vest as to 20,000 shares upon issuance and 6,667shares on the first day of each of the fourth through the eleventh months and 6,664 shares in the twelfth month and 40,000 shares to Samel, LLC to vest as to 10,000 shares upon issuance and 3,333 shares on the first day of each of the fourth throughthe eleventh months and 3,336 shares in the twelfth month. The vesting of each of the foregoing warrants will terminate in the event the JFS Agreement is terminated by the Company.

On October 1, 2010, the Company entered into an agreement with Garden State Securities Inc. (“GSS”) to provide certain financial advisory services to the Company on a non-exclusive basis(the “GSS Agreement”). The Company will issue an aggregate of up to 96,000 shares of the Company’s common stock as follows: 24,000 shares to GSS upon the signing of the GSS Agreement and 72,000 shares to be issued at the rate of 8,000shares for months four through twelve following the signing of the GSS Agreement if the GSS Agreement is in effect and has not been terminated by the Company as of that time. Pursuant to the GSS Agreement, the Company also granted a three-yearwarrant to purchase 80,000 shares of the Company’s common stock at an exercise price of $1.00 per share to GSS to vest as to 20,000 shares upon issuance and 6,667 shares on the first day of each of the fourth through the eleventh months and6,664 shares in the twelfth month. Pursuant to the GSS Agreement, the Company also granted a three-year warrant to purchase 80,000 shares of the Company’s common stock at an exercise price of $2.00 per share to vest as to 20,000 shares uponissuance and 6,667 shares on the first day of each of the fourth through the eleventh months and 6,664 shares in the twelfth month. The vesting of each of the foregoing warrants will terminate in the event the GSS Agreement is terminated by theCompany.

Research and Development

In connection with the Cedars-Sinai Medical Center License Agreement, the Company has certain commitments as described in Note 4.

In August 2010, the Company entered into a master service agreement with Averion International Corporation, a clinical research contract organization (“Averion”), to provide us with services inconnection with our planned Phase II clinical study for our dendritic cell-based cancer vaccine product candidate for the treatment of glioblastoma at an estimated total cost for such services during the course of the trial of approximately $3.5million over the next three years.

6. Shareholders’ Equity

Common Stock

In March 2010, the Company raised $1,654,686 (after commissions and offeringexpenses) from the sale of 1,740,000 shares of common stock and warrants to purchase 696,000 shares of common stock at an exercise price of $1.15 per share, to various investors in a private placement. (See “Warrants and WarrantLiabilities” below.)

In May 2010, the Company raised $2,716,308 (after commissions and offering expenses) from the sale of 2,490,910shares of common stock and warrants to purchase 1,245,455 shares of common stock at an

 

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exercise price of $1.50 per share, to various investors in a private placement. (See “Warrants and Warrant Liabilities” below)

Preferred Stock

On December 3, 2009, the Company entered into a Preferred StockPurchase Agreement dated as of December 3, 2009 (the “Preferred Stock Agreement”) with Socius Capital Group, LLC, a Delaware limited liability company d/b/a Socius Life Sciences Capital Group, LLC (the “Investor”). Pursuantto the Preferred Stock Agreement, the Company will issue to the Investor up to $10,000,000 of the Company’s newly created Series A Preferred Stock (the “Preferred Stock”). The purchase price of the Preferred Stock is $10,000 pershare. The shares of Preferred Stock that are issued to the Investor will bear a cumulative dividend of 10.0% per annum, payable in shares of Preferred Stock, will be redeemable under certain circumstances and will not be convertible intoshares of the Company’s common stock. Subject to the terms and conditions of the Preferred Stock Agreement, the Company has the right to determine (1) the number of shares of Preferred Stock that it will require the Investor to purchasefrom the Company, up to a maximum purchase price of $10,000,000, (2) whether it will require the Investor to purchase Preferred Stock in one or more traunches, and (3) the timing of such required purchase or purchases of Preferred Stock.

The terms of the Preferred Stock are set forth in a Certificate of Designations of Preferences, Rights and Limitations of Series A PreferredStock that the Company filed with the Delaware Secretary of State on December 3, 2009.

Pursuant to the Preferred Stock Agreement, theCompany agreed to pay the Investor a commitment fee of $500,000 (the “Commitment Fee”), with $250,000 payable when the Company makes its first election to require the Investor to purchase shares of Preferred Stock and with the remaining$250,000 payable when the aggregate amount of Preferred Stock purchased by the Investor equals at least $5,000,000; provided, however, that the first $250,000 portion of the Commitment Fee will be due and payable on the six-month anniversary of theeffective date of the registration statement described below even if no sales of Preferred Stock to the Investor have occurred by that date. The Company has the right to elect to pay each installment of the Commitment Fee in immediately availablefunds or by issuance of shares of common stock. In January 2010, the Company accrued $250,000 in commitment fees associated with the Preferred Stock Agreement.

Concurrently with its execution of the Preferred Stock Agreement, the Company issued to the Investor a warrant (the “Warrant”) to purchase shares of common stock with an aggregate exercise priceof up to $13,500,000 depending upon the amount of Preferred Stock that is purchased by the Investor. Each time that the Company requires the Investor to purchase shares of Preferred Stock, a portion of the Warrant will become exercisable by theInvestor over a five-year period for a number of shares of common stock equal to (1) the aggregate purchase price payable by the Investor for such shares of Preferred Stock multiplied by 135%, with such amount divided by (2) the per shareWarrant exercise price. The initial exercise price under the Warrant is $1.04 per share of common stock. Thereafter, the exercise price for each portion of the Warrant that becomes exercisable upon the Company’s election to require the Investorto purchase Preferred Stock will equal the closing price of the common stock on the date that the Company delivers its election notice. The Investor is entitled to pay the Warrant exercise price in immediately available funds, by delivery of asecured promissory note or, if a registration statement covering the resale of the common stock subject to the Warrant is not in effect, on a cashless basis.

Pursuant to the Preferred Stock Agreement, the Company agreed to file with the Securities and Exchange Commission a registration statement covering the resale of the shares of common stock that areissuable to the Investor under the Warrant and in satisfaction of the Commitment Fee. The registration statement was deemed effective on January 22, 2010. The 1.2 million shares of common stock registered for the Commitment Fee are held inescrow by the Company.

 

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On May 2, 2010, the Company issued and sold 400 shares of the Preferred Stock to Socius Capital Group,LLC pursuant to the terms of the Preferred Stock Agreement. The aggregate purchase price for the Preferred Stock was $4,000,000 (less $220,842 in Commitment Fees and offering expenses). Under the terms of the Preferred Stock Agreement, Sociusremains obligated, from time to time until December 3, 2012, to purchase up to an additional 600 shares of Preferred Stock at a purchase price of $10,000 per share upon notice from the Company to Socius, and subject to the satisfaction ofcertain conditions, as set forth in the Preferred Stock Agreement.

In connection with the foregoing transaction, a portion of the warrantsheld by an affiliate of Socius became vested and exercisable covering 2,700,000 shares of the Company’s common stock for a five-year period at an exercise price of $2.00 per share under the terms of the Preferred Stock Agreement. Inconsideration of Socius agreeing to grant the Company certain waivers under the Preferred Stock Agreement, this affiliate also became entitled to purchase up to an additional 1,350,000 shares of the Company’s common stock at an exercise priceof $2.50 per share. On May 2, 2010, the affiliate of Socius exercised a portion of its warrant for 1,675,000 shares and paid the $3,350,000 exercise price for these shares by delivering a four-year full recourse promissory note for this amount,as permitted by the Preferred Stock Agreement. The Company immediately thereafter redeemed approximately 248 shares of the Preferred Stock by offsetting the $3,350,000 redemption price for these shares against the $3,350,000 owed to the Companyunder the note. On December 2, 2010, the affiliate of Socius exercised the remaining portion of its warrant for 1,025,000 shares and paid the $2,050,000 exercise price for these shares by delivering a four-year full recourse promissory note forthis amount, as permitted by the Preferred Stock Agreement. The Company immediately thereafter redeemed approximately 152 shares of the Preferred Stock by offsetting the $2,050,000 redemption price for these shares against the $2,050,000 owed to theCompany under the note. (See “Warrants” and “Warrant Liabilities” below.)

Stock Options

In February 2005, the Company adopted an Equity Incentive Plan (“Plan”). Pursuant to the Plan, a committee appointed by the Board of Directorsmay grant, at its discretion, qualified or nonqualified stock options, stock appreciation rights and may grant or sell restricted stock to key individuals, including employees, nonemployee directors, consultants and advisors. Option prices forqualified incentive stock options (which may only be granted to employees) issued under the plan may not be less than 100% of the fair market value of the common stock on the date the option is granted (unless the option is granted to a person who,at the time of grant, owns more than 10% of the total combined voting power of all classes of stock of the Company; in which case the option price may not be less than 110% of the fair market value of the common stock on the date the option isgranted). Option prices for nonqualified stock options issued under the Plan are at the discretion of the committee and may be equal to, greater or less than fair market value of the common stock on the date the option is granted. The options vestover periods determined by the Board of Directors and are exercisable no later than ten years from date of grant (unless they are qualified incentive stock options granted to a person owning more than 10% of the total combined voting power of allclasses of stock of the Company, in which case the options are exercisable no later than five years from date of grant). As of December 31, 2010, the Company has reserved 6,000,000 shares of common stock for issuance under the Plan and optionsto purchase 3,761,421 common shares have been granted under the Plan that are currently outstanding.

The following is a summary of stockoption grants issued outside the Plan:

In January 2007, the Company granted an option to purchase 1,500,000 shares of its common stock at anexercise price of $1.10 per share to the Chairman of the Company’s Scientific Advisory Board.

In November 2006, the Company granted anoption to purchase 300,000 shares of its common stock at an exercise price of $1.00 per share to an affiliate of the Company’s then Chairman of the Board.

 

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In November 2006, the Company granted an option to purchase 5,933,424 shares of its common stock at anexercise price of $1.00 per share to a Board member in connection with the Cedars-Sinai license acquisition.

The following table summarizesstock option activity for the Company during the twelve months ended December 31, 2010:

 

   Options  Weighted
Average
Exercise
Price
   Weighted
Average
Remaining
Contractual
Term
   Aggregate
Intrinsic
Value
 

Outstanding December 31, 2007

   8,645,084   $1.02      

Granted

   1,100,000   $0.77      

Exercised

   —     $—        

Forfeited or expired

   (43,750 $0.86      
                   

Outstanding December 31, 2008

   9,701,334   $0.99      

Granted

   1,494,822   $0.43      

Exercised

   (509,229 $0.69      

Forfeited or expired

   (131,000 $0.93      
                   

Outstanding December 31, 2009

   10,555,927   $0.92      

Granted

   1,347,500   $0.91      

Exercised

   (455,332 $0.39      

Forfeited or expired

   (353,250 $1.04      
                   

Outstanding December 31, 2010

   11,094,845   $0.94     5.6    $4,690,490  
                   

Vested or expected to vest at December 31, 2010

   10,488,096   $0.94     5.9    $4,432,825  
                   

As of December 31, 2010, the total unrecognized compensation cost related to unvested stock options amounted to$448,481, which will be amortized over the weighted-average remaining requisite service period of less than one year.

Warrants

In connection with the March 2010 common stock private placement, the Company issued to the investors warrants to purchase 696,000 sharesof the Company’s common stock at $1.15 per share. The warrants have a term of 26 months from the date of issuance. On December 31, 2010, warrants to purchase 696,000 shares of the Company’s common stock were outstanding related tothis private placement. (See “Warrant Liabilities” below.)

In connection with the May 2010 common stock private placement, theCompany issued to the investors warrants to purchase 1,245,455 shares of the Company’s common stock at $1.50 per share. The warrants have a term of 36 months from the date of issuance. On December 31, 2010, warrants to purchase 1,245,455shares of the Company’s common stock were outstanding related to this private placement. (See “Warrant Liabilities” below.)

Inconnection with the May 2010 Preferred Stock sale, the Company issued warrants to purchase 2,700,000 shares of common stock at an exercise price of $2.00 held by an affiliate of Socius. The warrants

 

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have a term of five-year from the date of issuance. In consideration of Socius agreeing to grant the Company certain waivers under the Preferred Stock Purchase Agreement, this affiliate alsobecame entitled to purchase up to an additional 1,350,000 shares of the Company’s common stock at an exercise price of $2.50 per share. In May 2010, the affiliate of Socius exercised a portion of its warrant for 1,675,000 shares and paid the$3,350,000 exercise price for these shares by delivering a four-year full recourse promissory note for this amount, as permitted by the Preferred Stock Purchase Agreement. The Company immediately thereafter redeemed approximately 248 shares of thePreferred Stock by offsetting the $3,350,000 redemption price for these shares against the $3,350,000 owed to the Company under the note. In December 2010, the affiliate of Socius exercised the remaining portion of its warrant for 1,025,000 sharesand paid the $2,050,000 exercise price for these shares by delivering a four-year full recourse promissory note for this amount, as permitted by the Preferred Stock Purchase Agreement. The Company immediately thereafter redeemed approximately 152shares of the Preferred Stock by offsetting the $2,050,000 redemption price for these shares against the $2,050,000 owed to the Company under the note. On December 31, 2010, no warrants to purchase of the Company’s common stock at $2.00were outstanding and warrants to purchase 1,350,000 shares of the Company’s common stock at $2.50 were outstanding related to this private placement. (See “Warrant Liabilities” below.)

In connection with an investor relations agreement in December 2010, the Company issued a two-year warrant to purchase 50,000 shares of theCompany’s common stock at an exercise price of $1.60.

In January 2009, the Company delivered notice to warrant holders in connectionwith the reduction from $2.50 to $0.25 per share of the exercise price of warrants to purchase a total of 6,112,583 shares of the Company’s common stock and in connection with the extension of the expiration date of warrants to purchase a totalof 6,412,583 shares of the Company’s common stock from earlier dates in 2009 to June 30, 2009. The Company valued the warrant modification at $611,258, using the Black-Scholes pricing model and the following assumptions: contractual termof 0.45 years, an average risk-free interest rate of 0.29% a dividend yield of 0% and volatility of 118%. In the footnotes to the Company’s financial statements included in the Company’s Annual Report on Form 10-K for the year endedDecember 31, 2008, the Company disclosed that it anticipated taking a non-cash charge of approximately $500,000 in the first quarter of 2009. In the first quarter 2009, the Company determined that the warrant modification should be treated as adividend in-kind and not a non-cash charge, and since the Company was in a deficit position at the time of the modification, no dividend was recorded.

On June 30, 2009, the Company issued 1,970,992 shares of its common stock to 58 purchasers upon their exercise of warrants. The exercise price of 1,670,992 shares was $0.25 per share, and theexercise price of 300,000 shares was $0.15 per share. The Company received an aggregate purchase price of $462,748, and the Company did not pay any underwriting discounts or commissions in the transaction. As of December 31, 2009, the Companyhad no outstanding stock purchase warrants issued to investors.

Warrant Liabilities

In connection with the March 2010 common stock private placement, the Company issued to the investors warrants to purchase 696,000 shares of theCompany’s common stock at $1.15 per share. Of the total proceeds from the March 2010 common stock private placement, $257,520 was allocated to the freestanding warrants associated with the units based upon the fair value of the warrantsdetermined under the Black Scholes option pricing model. The warrants contain a provision whereby the warrant exercise price would be decreased in the event that certain future common stock issuances are made at a price less than $1.00.

Under ASC 815 “Derivatives and Hedging”, the March 2010 warrants do not qualify for equity treatment due to the potential variability of theirexercise price, and therefore are recognized as a liability. The warrant liability will be adjusted to fair value each reporting period, and any changes in value will be recognized in the statement of operations. The warrants contain a provisionwhereby the warrant exercise price would be decreased in the event that certain future common stock issuances are made at a price less than $1.00. We have concluded that the value of the conversion feature does not materially differ from thevaluation of such warrants using the Monte Carlo or lattice simulation models, and therefore the use of the Black-Scholes valuation model is considered a reasonable method to value the warrants. The assumptions used in the Black Scholes model fordetermining the initial fair value of the warrants were as

 

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follows: (i) dividend yield of 0%; (ii) expected volatility of 102%, (iii) risk-free interest rate of 1.00%, and (iv) contractual life of 26 months. For the year endedDecember 31, 2010, the Company recorded an other expense charge for the change in fair value of warrant liability of $215,760, with a carrying value of $473,280 at December 31, 2010.

In connection with the May 2010 common stock private placement, the Company issued to the investors warrants to purchase 1,245,455 shares of theCompany’s common stock at $1.50 per share. Of the total proceeds from the May 2010 common stock private placement, $834,455 was allocated to the freestanding warrants associated with the units based upon the fair value of the warrantsdetermined under the Black Scholes option pricing model. The warrants contain a provision whereby the warrant exercise price would be decreased in the event that certain future common stock issuances are made at a price less than $1.00.

Under ASC 815 “Derivatives and Hedging”, the May 2010 warrants do not qualify for equity treatment due to the potential variability of theirexercise price, and therefore are recognized as a liability. The warrant liability will be adjusted to fair value each reporting period, and any changes in value will be recognized in the statement of operations. The warrants contain a provisionwhereby the warrant exercise price would be decreased in the event that certain future common stock issuances are made at a price less than $1.00. We have concluded that the value of the conversion feature does not materially differ from thevaluation of such warrants using the Monte Carlo or lattice simulation models, and therefore the use of the Black-Scholes valuation model is considered a reasonable method to value the warrants. The assumptions used in the Black Scholes model fordetermining the initial fair value of the warrants were as follows: (i) dividend yield of 0%; (ii) expected volatility of 102%, (iii) risk-free interest rate of 1.375%, and (iv) contractual life of 36 months. For the year endedDecember 31, 2010, the Company recorded an other income charge for the change in fair value of warrant liability of $99,636 with a carrying value of $934,091 at December 31, 2010.

In connection with the May 2010 Preferred Stock sale, the Company vested warrants to purchase 2,700,000 shares of common stock at an exercise price of $2.00 held by an affiliate of Socius and issuedwarrants to purchase an additional 1,350,000 shares of the Company’s common stock at an exercise price of $2.50 per share. Of the total proceeds from the May 2010 preferred stock sale, $5,710,500 was allocated to the freestanding warrantsassociated with the units based upon the fair value of these warrants determined under the Black Scholes option pricing model. The excess of the value of the freestanding warrants over the net proceeds of $1,931,342 was charged to change in fairvalue of warrant liability in the statement of operations. The warrants contain a provision whereby the warrant may be settled for cash in connection with a change of control with a private company. In May 2010, the affiliate of Socius exercised aportion of its warrant for 1,675,000 shares, which reduced warrant liabilities by $2,395,250. In December 2010, the affiliate of Socius exercised a portion of its warrant for 1,025,000 shares, which reduced warrant liabilities by $912,250.

Under ASC 815 “Derivatives and Hedging”, the May 2010 Preferred Stock warrants do not qualify for equity treatment, and arerecognized as a liability. The warrant liability will be adjusted to fair value each reporting period, and any changes in value will be recognized in the statement of operations. The warrants contain a provision whereby the warrant may be settledfor cash in connection with a change of control with a private company. Since settlement feature included in the warrant agreement is calculated using the Black-Scholes valuation model, the Company uses the Black-Scholes valuation model to value thewarrants. The assumptions used in the Black Scholes model for determining the initial fair value of the warrants were as follows: (i) dividend yield of 0%; (ii) expected volatility of 102%, (iii) risk-free interest rate of 2.50%, and(iv) contractual life of 60 months. For the year ended December 31, 2010, the Company recorded an other income charge for the change in fair value of warrant liability of $1,228,500, with a carrying value of $1,174,500 at December 31,2010.

The following is a reconciliation of the beginning and ending balances for warrant liabilities measured at fair value on a recurringbasis using significant unobservable inputs (Level 3) during the period ended December 31, 2010:

 

   Warrant
Liabilities
 

Balance – January 1, 2010

  $—   

Issuance of warrants

   6,907,609  

Exercise of warrants

   (3,307,500

(Gain) or Loss included in earnings

   (1,018,238

Transfers in and/or out of Level 3

   —   
     

Balance – December 31, 2010

  $2,581,871  
     

Promissory Note

In October 2009, the Company’s former President exercised stock options for 150,479 shares of common stock and as provided under the stock option agreement provided the Company with a full recourse

 

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five-year promissory note bearing interest of 2.59% per annum. The promissory note is secured by a pledge of shares being acquired with all proceeds of any sale to be applied first to retirein full the promissory note. The Company recorded the promissory note as an offset against shareholders’ equity. For the year ended December 31, 2010, the Company recorded interest income of $1,614.

7. Income Taxes

Deferred taxesrepresent the net tax effects of the temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes. Temporary differences result primarily from the recording of tax benefits of net operating loss carryforwards and start-up costs that will be amortized for tax purposes once the Company begins doing business as defined by the Internal Revenue Code.

As of December 31, 2010, the Company has an insufficient history to support the likelihood of ultimate realization of the benefit associated with the deferred tax asset. Accordingly, a valuationallowance has been established for the full amount of the net deferred tax asset.

The Company’s effective income tax rate differs fromthe amount computed by applying the federal statutory income tax rate to loss before income taxes as follows:

 

       2008          2009          2010     

Income tax benefit at the federal statutory rate

   (34%)   (34%)   (34%) 

State income tax benefit, net of federal tax benefit

   (6%)   (6%)   (6%) 

Change in fair value of warrant liability

   —      —      (7%) 

Change in valuation allowance for deferred tax assets

   40  40  47
             

Total

   —      —      —    
             

Deferred taxes consisted of the following:

 

   December 31,
2009
  December 31,
2010
 

Net operating loss carryforwards

   $2,888,051   $4,617,671  

Stock-based compensation

   2,488,808    2,811,949  

Less valuation allowance

   (5,376,859  (7,429,620
         

Net deferred tax asset

  $—     $—    
         

At December 31, 2009 and December 31, 2010, the Company had approximately $7,220,127 and $11,544,178,respectively, of net operating loss carryforwards. Due to our equity financing transactions, and other owner shifts as defined in Section 382 of the Internal Revenue Code of 1986, as amended, or the Code, we incurred “ownershipchanges” pursuant to the Code. Accordingly, our use of net operating loss carryforwards is limited. We are currently studying the impact of Section 382 on the future realization of our various tax attributes. Such losses expire in 2024through 2030 as of December 31, 2010. The utilization of the carryforwards is dependent upon the Company’s ability to generate sufficient taxable income during the carryforward period.

As of the date of adoption of ASC 740 and the years ended December 31, 2010, 2009 and 2008, the tax returns for 2008 through 2010 remain open toexamination by the Internal Revenue Service and state tax authority.

8. Comprehensive Loss

For the year ended December 31, 2010, there was no other comprehensive loss and accordingly a Statement of Other Comprehensive Loss has not beenpresented. Comprehensive income would normally include: foreign currency translation adjustments, a change in the market value of a futures contract that qualifies as a hedge of an asset reported at fair value, a net loss recognized as an additionalpension liability not yet recognized as net periodic pension cost, and unrealized holding gains and losses on available-for-sale securities.

9. Subsequent Events

PrivatePlacement

In February 2011, the Company raised $8,090,664 (before commissions and offering expenses) from the sale of 5,219,768 shares ofcommon stock and warrants to purchase 2,609,898 shares of common stock at an exercise price of $2.25 per share, to various investors in a private placement. The warrants have a term of

 

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60 months from the date of issuance. As a result of the Financing Transaction, the Company at the Closing issued to Summer Street Research Partners and Dawson James Securities, Inc.(collectively, the “Placement Agents”), who served as the placement agents for the Financing Transactions, warrants to purchase up to 208,791 shares of Common Stock (the “Placement Agent Warrants”) on the same terms andconditions as the Investor Warrants and paid a commission of $566,345 to the Placement Agents as well as certain of their expenses.

Sponsored Research and Vaccine Production Agreement

In January 2011, the Company entered in to a Sponsored Research and Vaccine Production Agreement with the University of Pennsylvania extending our existing sponsored research agreement with thatinstitution and providing certain manufacturing services for ICT-107 vaccine for use in our Phase II clinical trial.

Research Agreement

In January 2011, the Company amended the agreement with Averion to provide additional services in connection with our planned Phase IIclinical study for our dendritic cell-based cancer vaccine product candidate for the treatment of glioblastoma for an additional cost of $469,807.

 

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PART II – INFORMATION NOT REQUIRED IN PROSPECTUS

 

ITEM 13.OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION

We estimate that expenses in connection with the distribution described in this registration statement (other than brokerage commissions, discounts or other expenses relating to the sale of the shares bythe selling stockholders) will be as set forth below. We will pay all of the expenses with respect to the distribution, and such amounts, with the exception of the Securities and Exchange Commission registration fee, are estimates.

 

SEC registration fee

  $2,099.85  

Accounting fees and expenses

  $7,500.00  

Legal fees and expenses

  $25,000.00  

Printing and related expenses

  $15,000.00  

Total

  $49,599.85  

 

ITEM 14.INDEMNIFICATION OF DIRECTORS AND OFFICERS

Our Certificate of Incorporation provides that no officer or director shall be personally liable to this corporation or our stockholders for monetary damages except as provided pursuant to Delaware law.Our Bylaws and Certificate of Incorporation also provide that we shall indemnify and hold harmless each person who serves at any time as a director, officer, employee or agent of the company from and against any and all claims, judgments andliabilities to which such person shall become subject by reason of the fact that he is or was a director, officer, employee or agent of the company and shall reimburse such person for all legal and other expenses reasonably incurred by him or her inconnection with any such claim or liability. We also have the power to defend such person from all suits or claims in accord with the Delaware law. In certain cases, we may advance expenses incurred in defending any such proceeding. The rightsaccruing to any person under our Bylaws and Certificate of Incorporation do not exclude any other right to which any such person may lawfully be entitled, and we may indemnify or reimburse such person in any proper case, even though not specificallyprovided for by the Bylaws and Certificate of Incorporation.

Insofar as indemnification for liabilities for damages arisingunder the Securities Act of 1933 may be permitted to our directors, officers, and controlling persons pursuant to the foregoing provision, or otherwise, we have been advised that in the opinion of the Securities and Exchange Commission suchindemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.

 

ITEM 15.RECENT SALES OF UNREGISTERED SECURITIES

In June 2008, we issued to Cedars Sinai Medical Center 100,000 shares of our common stock as a licensing fee. These securities were issued by us in reliance upon an exemption from registration underSection 4(2) of the Securities Act.

In June 2008 we granted a seven-year non-qualified option to purchase 25,000 sharesof our common stock at an exercise price of $0.65 per share to Dr. Navdeep Jaikaria under our 2006 Equity Incentive Plan as consideration for his services as a director. These securities were issued by us in reliance upon an exemption fromregistration under Section 4(2) of the Securities Act.

In September 2009, we granted seven-year non-qualified options topurchase an aggregate of 270,000 shares of the our common stock at an exercise price of $0.95 per share under our 2006 Equity Incentive Plan to the directors as compensation for serving on our Board of Directors These securities were issued by us inreliance upon an exemption from registration under Section 4(2) of the Securities Act.

In March 2010, we granted aseven-year incentive stock option to purchase 150,000 shares of our common stock at an exercise price of $0.90 per share to Dr. James Bender under our 2006 Equity Incentive Plan pursuant to an Employment Agreement with Dr. Bender. Thesesecurities were issued by us in reliance upon an exemption from registration under Section 4(2) of the Securities Act.

 

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In March 2010, we granted a seven-year incentive stock option to purchase 150,000 shares ofour common stock at an exercise price of $0.90 per share to Dr. Manish Singh under our 2006 Equity Incentive Plan pursuant to an Employment Agreement with Dr. Singh. These securities were issued by us in reliance upon an exemption fromregistration under Section 4(2) of the Securities Act.

In March 2010, we granted a seven-year non-qualified stock optionto purchase 125,000 shares of our common stock at an exercise price of $0.90 per share to Dr. John Yu under our 2006 Equity Incentive Plan pursuant to an Employment Agreement with Dr. Yu. These securities were issued by us in reliance uponan exemption from registration under Section 4(2) of the Securities Act.

In March 2010, we granted a five-yearnon-qualified stock option to purchase 150,000 shares of our common stock at an exercise price of $0.90 per share to Dr. Elma Hawkins under our 2006 Equity Incentive Plan pursuant to an Employment Agreement with Dr. Hawkins. Thesesecurities were issued by us in reliance upon an exemption from registration under Section 4(2) of the Securities Act.

In March 2010, we completed a private placement of our securities to 18 accredited investors. We sold to these investors 1,740,000units at a price of $1.00 per unit, with each unit consisting of one share of our common stock and a 26-month warrant to purchase 0.4 of a share of our common stock at an exercise price of $1.15 per share. We paid a broker-dealer a fee forassistance in identifying the investors in this private placement that included a 26-month warrant to purchase 104,400 shares of our common stock at an exercise price of $1.15 per share. These securities were issued by us in reliance upon anexemption from registration under Section 4(2) of the Act.

In May 2010, we sold 400 shares of our Series APreferred Stock to Socius Capital Group, LLC for $10,000 per share under our existing preferred stock purchase agreement with that institutional investor. In connection with this transaction, we issued a five-year warrant to Socius CGII, Ltd., anaffiliate of Socius Capital Group, to purchase 1,350,000 shares of our common stock at $2.50 per share. Both of these securities were issued by us in reliance upon an exemption from registration under Section 4(2) of the Act.

In May 2010, we completed a private placement of our securities to 12 accredited investors. We sold to these investors 2,490,910 units ata price of $1.10 per unit, with each unit consisting of one share of our common stock and a 36-month warrant to purchase 0.5 of a share of our common stock at an exercise price of $1.50 per share. We paid a broker-dealer a fee for assistance inidentifying the investors in this private placement that included a 36-month warrant to purchase 42,318 shares of our common stock at an exercise price of $1.50 per share. These securities were issued by us in reliance upon an exemption fromregistration under Section 4(2) of the Act.

In February 2011, the Company raised $8,090,664 (before commissions andoffering expenses) from the sale of 5,219,768 shares of common stock and warrants to purchase 2,609,898 shares of common stock at an exercise price of $2.25 per share, to various investors in a private placement. The warrants have a term of 60months from the date of issuance. As a result of the Financing Transaction, the Company at the Closing issued to Summer Street Research Partners and Dawson James Securities, Inc. (collectively, the “Placement Agents”), who served as theplacement agents for the Financing Transactions, warrants to purchase up to 208,791 shares of Common Stock (the “Placement Agent Warrants”) on the same terms and conditions as the Investor Warrants and paid a commission of $566,345 to thePlacement Agents as well as certain of their expenses.

 

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ITEM 16.EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

Exhibit Index

 

Exhibit Number

  

Description

  2.1

  Agreement and Plan of Reorganization dated as of May 5, 2005, as amended, among Patco Industries Subsidiary, Inc., William C. Patridge, and Spectral Molecular Imaging, Inc., asamended on June 30, 2005, September 26, 2005 and January 20, 2006. (1)

  3.1

  Amended and Restated Certificate of Incorporation of ImmunoCellular Therapeutics, Ltd. (2)

  3.2

  Certificate of Amendment to Amended and Restated Certificate of Incorporation of ImmunoCellular Therapeutics, Ltd. (2)

  3.3

  Certificate of Amendment to Amended and Restated Certificate of Incorporation of ImmunoCellular Therapeutics, Ltd. (3)

  3.4

  Amended and Restated Bylaws of ImmunoCellular Therapeutics, Ltd. (4)

  3.5

  Amended and Restated Bylaws of ImmunoCellular Therapeutics, Ltd. (25)

  3.6

  Amended and Restated 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (25)

  4.1

  Form of Common Stock Certificate for ImmunoCellular Therapeutics, Ltd. (5)

  4.2

  Form of Subscription Agreement containing registration rights issued by Spectral Molecular Imaging, Inc. in January 2006 and assumed by ImmunoCellular Therapeutics, Ltd.(4)

  4.3

  Form of Warrant issued in January 2006 to purchase shares of the common stock of Spectral Molecular Imaging, Inc. and assumed by ImmunoCellular Therapeutics, Ltd.(4)

  4.4

  Subscription Agreement dated as of February 16, 2007 between ImmunoCellular Therapeutics, Ltd. and RAB Special Situations (Master) Fund Limited. (6)

  4.5

  Letter Agreement dated as of February 16, 2007 between ImmunoCellular Therapeutics, Ltd. and RAB Special Situations (Master) Fund Limited. (6)

  4.6

  Subscription Agreement dated as of April 19, 2007 between ImmunoCellular Therapeutics, Ltd. and RAB Special Situations (Master) Fund Limited. (6)

  4.7

  Warrant dated as of February 16, 2007 issued by ImmunoCellular Therapeutics, Ltd. to Credit Suisse Client Nominees (UK) Limited, as nominee for RAB Special Situations (Master) FundLimited, for the purchase of 800,000 shares of the common stock of ImmunoCellular Therapeutics, Ltd. (6)

  4.8

  Warrant dated as of February 16, 2007 issued by ImmunoCellular Therapeutics, Ltd. to Credit Suisse Client Nominees (UK) Limited, as nominee for RAB Special Situations (Master) FundLimited, for the purchase of 533,334 shares of the common stock of ImmunoCellular Therapeutics, Ltd. (6)

  4.9

  Warrant dated as of April 19, 2007 issued by ImmunoCellular Therapeutics, Ltd. to Credit Suisse Client Nominees (UK) Limited, as nominee for RAB Special Situations (Master)Fund Limited, for the purchase of 200,000 shares of the common stock of ImmunoCellular Therapeutics, Ltd. (6)

 

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  4.10

  Warrant dated as of April 19, 2007 issued by ImmunoCellular Therapeutics, Ltd. to Credit Suisse Client Nominees (UK) Limited, as nominee for RAB Special Situations (Master)Fund Limited, for the purchase of 133,334 shares of the common stock of ImmunoCellular Therapeutics, Ltd. (6)

  4.11

  Form of Subscription Agreement containing registration rights between the participants in the April/May 2007 private placement and ImmunoCellular Therapeutics, Ltd.(7)

  4.12

  Form of Warrant issued to participants in the April/May 2007 private placement to purchase shares of common stock of ImmunoCellular Therapeutics, Ltd. (7)

  4.13

  Form of Notice of Exercise of Warrants delivered by ImmunoCellular Therapeutics, Ltd. in January 2009 in connection with the reduction from $2.50 to $0.25 per share of the exerciseprice of warrants to purchase a total of 6,112,583 shares of common stock of ImmunoCellular Therapeutics, Ltd. and in connection with the extension of the expiration date of warrants to purchase a total of 6,412,583 shares of common stock ofImmunoCellular Therapeutics, Ltd. (17)

  4.14

  Certificate of Designations of Preferences, Rights and Limitations of Series A Preferred Stock dated December 3, 2009. (20)

  4.15

  Warrant dated December 3, 2009 issued by ImmunoCellular Therapeutics, Ltd. to Socius Capital Group, LLC d/b/a Socius Life Sciences Capital Group, LLC (20)

  4.16

  

Amended Certificate of Designations of Preferences, Rights and Limitations of Series A Preferred Stock dated

May 3, 2010. (22)

  4.17

  Form of Warrant issued to participants in the March 2010 private placement to purchase shares of common stock of ImmunoCellular Therapeutics, Ltd. (22)

  4.18

  Warrant dated May 2, 2010 for 1,350,000 shares issued by ImmunoCellular Therapeutics, Ltd. to Socius CG II, Ltd. (22)

  4.19

  Form of Warrant issued to participants in the February 2011 private placement to purchase shares of common stock of ImmunoCellular Therapeutics, Ltd. (26)

  5.1

  Opinion of TroyGould PC.**

10.1

  Exclusive License Agreement dated as of November 17, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd.† (8)

10.2

  First Amendment to Exclusive License Agreement dated as of June 16, 2008 2006, between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd.† (9)

10.3

  Stock Purchase Agreement dated as of November 17, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd. (8)

10.4

  Registration Rights Agreement dated as of November 17, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd. (8)

10.5

  Securities Purchase Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd. (8)

10.6

  Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd.* (8)

10.7

  Nonqualified Stock Option Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd.* (8)

10.8

  Registration Rights Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd. (8)

10.9

  2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (4)

 

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10.10

  Amendment No. 1 to the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (10)

10.11

  Amendment No. 2 to the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (11)

10.12

  Amendment No. 3 to the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (11)

10.13

  Amendment No. 4 to the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (9)

10.14

  Form of Non-Qualified Stock Option Agreement for the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (12)

10.15

  Form of Incentive Stock Option Agreement for the 2006 Equity Incentive Plan of ImmunoCellular
Therapeutics, Ltd. (12)

10.16

  Employment Agreement dated as of February 18, 2008 between Dr. Manish Singh and ImmunoCellular
Therapeutics, Ltd.* (11)

10.17

  Employment Agreement dated as of February 18, 2009 between Dr. Manish Singh and ImmunoCellular Therapeutics, Ltd.* (17)

10.18

  Employment Agreement dated as of November 5, 2007 between C. Kirk Peacock and ImmunoCellular Therapeutics, Ltd. (13)

10.19

  Employment Agreement dated as of October 30, 2008 between C. Kirk Peacock and ImmunoCellular Therapeutics, Ltd.* (17)

10.20

  Agreement dated as of July 7, 2006 between Technomedics Management & Systems, Inc. and ImmunoCellular Therapeutics, Ltd. (14)

10.21

  Agreement dated as of November 17, 2006 between Technomedics Management & Systems, Inc. and ImmunoCellular Therapeutics, Ltd.* (5)

10.22

  Memorandum of Agreement dated as of November 21, 2007 between Molecular Discoveries LLC and ImmunoCellular Therapeutics, Ltd. (11)

10.23

  Agreement dated as of February 14, 2008 between Molecular Discoveries, LLC and ImmunoCellular Therapeutics, Ltd. (11)

10.24

  Registration Rights Agreement dated as of April 14, 2008, between Molecular Discoveries, LLC and ImmunoCellular Therapeutics, Ltd. (15)

10.25

  Agreement dated as of February 14, 2008 between Dr. Cohava Gelber and ImmunoCellular Therapeutics, Ltd. (11)*

10.26

  Agreement dated as of August 1, 2008 between Dr. Cohava Gelber and ImmunoCellular Therapeutics, Ltd. * (17)

10.27

  Agreement dated as of September 1, 2008 between James G. Bender and ImmunoCellular Therapeutics, Ltd. (16) *

10.28

  Office lease dated April 28, 2008 between Regent Business Centers and ImmunoCellular Therapeutics, Ltd., as amended. (17)

10.29

  Amendment No. 1 to Agreement dated as of May 1, 2009 to Agreement dated October 30, 2008 between C. Kirk Peacock and ImmunoCellular Therapeutics, Ltd.*(18)

10.30

  Second Amendment dated August 1, 2009 to Exclusive License Agreement dated as of November 1, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd.(19)

 

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10.31

  Preferred Stock Purchase Agreement dated as of December 3, 2009 between ImmunoCellular Therapeutics, Ltd. and Socius Capital Group, LLC d/b/a Socius Life Sciences CapitalGroup, LLC. (20)

10.32

  Employment Agreement dated as of October 30, 2009 between C. Kirk Peacock and ImmunoCellular Therapeutics, Ltd. *(21)

10.33

  Employment Agreement dated as of February 1, 2010 between James G. Bender and ImmunoCellular Therapeutics, Ltd. * (27)

10.34

  Employment Agreement dated as of February 18, 2010 between Dr. Manish Singh and ImmunoCellular Therapeutics, Ltd. * (27)

10.35

  Agreement dated March 1, 2010 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd. * (27)

10.36

  Securities Purchase Agreement dated March 29, 2010 between participants in the March 2010 private placement and ImmunoCellular Therapeutics, Ltd. (23)

10.37

  Form of Registration Rights Agreement dated as of March 29, 2010 between participants in the March 2010 private placement and ImmunoCellular Therapeutics, Ltd. (22)

10.38

  Agreement dated as of March 4, 2010 between Dr. Elma Hawkins and ImmunoCellular Therapeutics, Ltd.* (22)

10.39

  Office Lease dated April 1, 2010 between Regent Business Centers and ImmunoCellular Therapeutics, Ltd. (22)

10.40

  Modification Agreement dated May 2, 2010 among Socius CG II, Ltd., Socius Life Sciences Capital Group, LLC and ImmunoCellular Therapeutics, Ltd. (22)

10.41

  Third Amendment dated March 26, 2010 to Exclusive License Agreement dated as of November 1, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd.(22)

10.42

  Securities Purchase Agreement dated May 12, 2010 between participants in the May 2010 private placement and ImmunoCellular Therapeutics, Ltd. (23)

10.43

  Form of Registration Rights Agreement between participants in the May 2010 private placement and ImmunoCellular Therapeutics, Ltd. (23)

10.44

  Employment Agreement dated as of October 30, 2010 between C. Kirk Peacock and ImmunoCellular Therapeutics, Ltd.* (24)

10.45

  Office Lease dated May 7, 2010 between Regent Business Centers and ImmunoCellular Therapeutics, Ltd. (23)

10.46

  Purchase Agreement, dated as of February 22, 2011, by and between the Company and each investor named
therein. (26)

10.47

  Registration Rights Agreement, dated as of February 22, 2011, by and among the Company and the investors named therein. (26)

10.48

  Exclusive Sublicense Agreement dated May 28, 2010 between Targepeutics, Inc. and ImmunoCellular Therapeutics, Ltd. † (28)

10.49

  Sponsored Research and Vaccine Production Agreement dated January 1, 2011 between The Trustees of the University of Pennsylvania and ImmunoCellular Therapeutics, Ltd. †(28)

10.50

  Placement agent agreement dated March 30, 2010 between Gilford Securities Incorporated and ImmunoCellular Therapeutics, Ltd.(28)

 

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10.51

  Placement agent agreement dated April 7, 2010 between Scarsdale Equities LLC and ImmunoCellular Therapeutics, Ltd. (28)

10.52

  Consulting Agreement dated October 1, 2010 between JFS Investments and ImmunoCellular Therapeutics, Ltd. (28)

10.53

  Advisory services agreement dated October 1, 2010 between Garden State Securities Inc. and ImmunoCellular Therapeutics, Ltd. (28)

10.54

  Co-placement Agents Agreement dated January 31, 2011 among Summer Street Research Partners, Dawson James Securities, Inc. and ImmunoCellular Therapeutics, Ltd. (28)

23.1  

  Consent of Marcum LLP. **

23.2  

  Consent of Stonefield Josephson, Inc. **

23.3  

  Consent of TroyGould PC (included in Exhibit 5.1).

 

Certain portions of the exhibit have been omitted based upon a request for confidential treatment filed by us with the Securities and Exchange Commission. The omittedportions of the exhibit have been separately filed by us with the Securities and Exchange Commission.
*Indicates a management contract or compensatory plan or arrangement.
**Filed with this Registration Statement on Form S-1.
(1)Previously filed by us on January 26, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(2)Previously filed by us on November 3, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(3)Previously filed by us on May 9, 2007 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(4)Previously filed by us on February 6, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(5)Previously filed by us on February 12, 2007 as an exhibit to our Registration Statement on Form SB-2, File No. 333-140598, and incorporated herein byreference.
(6)Previously filed by us on May 1, 2007 as an exhibit to our Registration Statement on Form SB-2, File No. 333-142480, and incorporated herein by reference.
(7)Previously filed by us on July 12, 2007 as an exhibit to our Registration Statement on Form SB-2, File No. 333-144521, and incorporated herein by reference
(8)Previously filed by us on November 22, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(9)Previously filed by us on August 14, 2008 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.
(10)Previously filed by us on September 14, 2007 as an exhibit to our Registration Statement on Form SB-2/A and incorporated herein by reference.
(11)Previously filed by us on March 25, 2008 as an exhibit to our Annual Report on Form 10-KSB and incorporated herein by reference.

 

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(12)Previously filed by us on November 9, 2007 as an exhibit to our Registration Statement on Form S-8, File No. 333-147278, and incorporated herein by reference.
(13)Previously filed by us on November 6, 2007 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(14)Previously filed by us on April 2, 2007 as an exhibit to our Annual Report on Form 10-KSB and incorporated herein by reference.
(15)Previously filed by us on April 16, 2008 as an exhibit to our Registration Statement on Form S-1, File No. 333-150277, and incorporated herein by reference.
(16)Previously filed by us on November 13, 2008 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.
(17)Previously filed by us on March 30, 2009 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.
(18)Previously filed by us on August 14, 2009 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.
(19)Previously filed by us on November 13, 2009 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.
(20)Previously filed by us on December 7, 2009 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(21)Previously filed by us on December 23, 2009 as an exhibit to our Registration Statement on Form S-1 and incorporated herein by reference.
(22)Previously filed by us on May 12, 2010 as an exhibit to our Registration Statement on Form S-1 to SB-2, File No. 333-144521 and incorporated herein byreference.
(23)Previously filed by us on May 18, 2010 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.
(24)Previously filed by us on November 15, 2010 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.
(25)Previously filed by us on January 11, 2011 as an exhibit to our Registration Statement on Form S-8 and incorporated herein by reference.
(26)Previously filed by us on February 25, 2011 as an exhibit to our current report on Form 8-K and incorporated herein by reference.
(27)Previously filed by us on March 31, 2010 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.
(28)Previously filed by us on March 31, 2011 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.

 

ITEM 17.UNDERTAKINGS

Theundersigned Registrant hereby undertakes:

(1) To file, during any period in which offers or sales are being made, apost-effective amendment to this registration statement to:

(i) To include any prospectus required by Section 10(a)(3)of the Securities Act.

(ii) To reflect in the prospectus any facts or events arising after the effective date of theregistration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, anyincrease or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected inthe form of prospectus filed with the Securities and Exchange Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the“Calculation of Registration Fee” table in the effective registration statement; and

 

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(iii) To include any material information with respect to the plan of distribution notpreviously disclosed in the registration statement or any material change to such information in the registration statement;

(2) That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to bea new registration statement relating to securities offered therein, and the offering of the securities at that time shall be deemed to be the initial bona fide offering thereof;

(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at thetermination of the offering;

(4) That, for the purpose of determining liability under the Securities Act to any purchaser,each prospectus filed pursuant to Rule 424(b) as part of a registration statement relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance on Rule 430A, shall be deemed to be partof and included in the registration statement as of the date it is first used after effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a documentincorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use, supersede or modify anystatement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such date of first use.

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controllingpersons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the SecuritiesAct and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in thesuccessful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has beensettled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act and will be governed by the final adjudication of such issue.

 

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SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the Registrant has duly caused this registration statement to be signed on its behalf by the undersigned, in Los Angeles, California, onApril 5, 2011.

 

IMMUNOCELLULAR THERAPEUTICS, LTD.
By:  

/s/ Manish Singh

 

Manish Singh, Ph.D.

Presidentand Chief Executive Officer

POWER OF ATTORNEY

KNOW ALL PERSONS BY THESE PRESENTS, that each individual whose signature appears below constitutes and appoints Dr. Manish Singh andDr. John Yu, and each of them, his true and lawful attorneys-in-fact and agents with full power of substitution, for him an din his name, place and stead, in any and all capacities, to sign any and all amendments (including post-effectiveamendments) to this registration statement, and to sign any registration statement for the same offering covered by this registration statement that is to be effective on filing pursuant to Rule 462(b) promulgated under the Securities Act and allpost-effective amendments thereto, and to file the same, with all exhibits thereto and all documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of the, full powerand authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that saidattorneys-in-fact and agents or any of them, or his or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Act, this registration statement has been signed by the following persons on behalf of the registrant and in the capacities and on the dates indicated:

 

Signature

  

Title

  

Date

/s/ Manish Singh

  

President, Chief Executive Officer and

Director (Principal Executive Officer)

  April 5, 2011

Manish Singh, Ph.D.

    

/s/ David Fractor

  

Chief Financial Officer (Principal

Financial and Accounting Officer)

  April 5, 2011

David Fractor

    

/s/ John Yu

  

Director

  April 5, 2011

John Yu, M.D.

    

/s/ Jacqueline Brandwynne

  

Director

  April 5, 2011

Jacqueline Brandwynne

    

/s/ Richard A. Cowell

  

Director

  April 5, 2011

Richard A. Cowell

    

/s/ Navdeep Jaikaria

  

Director

  April 5, 2011

Navdeep Jaikaria

    

/s/ Rahul Singhvi

  

Director

  April 5, 2011

Rahul Singhvi

    

 

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EXHIBIT INDEX

 

Exhibit Number

  

Description

  2.1

  Agreement and Plan of Reorganization dated as of May 5, 2005, as amended, among Patco Industries Subsidiary, Inc., William C. Patridge, and Spectral Molecular Imaging, Inc., asamended on June 30, 2005, September 26, 2005 and January 20, 2006. (1)

  3.1

  Amended and Restated Certificate of Incorporation of ImmunoCellular Therapeutics, Ltd. (2)

  3.2

  Certificate of Amendment to Amended and Restated Certificate of Incorporation of ImmunoCellular Therapeutics, Ltd. (2)

  3.3

  Certificate of Amendment to Amended and Restated Certificate of Incorporation of ImmunoCellular Therapeutics, Ltd. (3)

  3.4

  Amended and Restated Bylaws of ImmunoCellular Therapeutics, Ltd. (4)

  3.5

  Amended and Restated Bylaws of ImmunoCellular Therapeutics, Ltd. (25)

  3.6

  Amended and Restated 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (25)

  4.1

  Form of Common Stock Certificate for ImmunoCellular Therapeutics, Ltd. (5)

  4.2

  Form of Subscription Agreement containing registration rights issued by Spectral Molecular Imaging, Inc. in January 2006 and assumed by ImmunoCellular Therapeutics, Ltd.(4)

  4.3

  Form of Warrant issued in January 2006 to purchase shares of the common stock of Spectral Molecular Imaging, Inc. and assumed by ImmunoCellular Therapeutics, Ltd.(4)

  4.4

  Subscription Agreement dated as of February 16, 2007 between ImmunoCellular Therapeutics, Ltd. and RAB Special Situations (Master) Fund Limited. (6)

  4.5

  Letter Agreement dated as of February 16, 2007 between ImmunoCellular Therapeutics, Ltd. and RAB Special Situations (Master) Fund Limited. (6)

  4.6

  Subscription Agreement dated as of April 19, 2007 between ImmunoCellular Therapeutics, Ltd. and RAB Special Situations (Master) Fund Limited. (6)

  4.7

  Warrant dated as of February 16, 2007 issued by ImmunoCellular Therapeutics, Ltd. to Credit Suisse Client Nominees (UK) Limited, as nominee for RAB Special Situations (Master) FundLimited, for the purchase of 800,000 shares of the common stock of ImmunoCellular Therapeutics, Ltd. (6)

  4.8

  Warrant dated as of February 16, 2007 issued by ImmunoCellular Therapeutics, Ltd. to Credit Suisse Client Nominees (UK) Limited, as nominee for RAB Special Situations (Master) FundLimited, for the purchase of 533,334 shares of the common stock of ImmunoCellular Therapeutics, Ltd. (6)

  4.9

  Warrant dated as of April 19, 2007 issued by ImmunoCellular Therapeutics, Ltd. to Credit Suisse Client Nominees (UK) Limited, as nominee for RAB Special Situations (Master)Fund Limited, for the purchase of 200,000 shares of the common stock of ImmunoCellular Therapeutics, Ltd. (6)

 

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  4.10

  Warrant dated as of April 19, 2007 issued by ImmunoCellular Therapeutics, Ltd. to Credit Suisse Client Nominees (UK) Limited, as nominee for RAB Special Situations (Master)Fund Limited, for the purchase of 133,334 shares of the common stock of ImmunoCellular Therapeutics, Ltd. (6)

  4.11

  Form of Subscription Agreement containing registration rights between the participants in the April/May 2007 private placement and ImmunoCellular Therapeutics, Ltd.(7)

  4.12

  Form of Warrant issued to participants in the April/May 2007 private placement to purchase shares of common stock of ImmunoCellular Therapeutics, Ltd. (7)

  4.13

  Form of Notice of Exercise of Warrants delivered by ImmunoCellular Therapeutics, Ltd. in January 2009 in connection with the reduction from $2.50 to $0.25 per share of the exerciseprice of warrants to purchase a total of 6,112,583 shares of common stock of ImmunoCellular Therapeutics, Ltd. and in connection with the extension of the expiration date of warrants to purchase a total of 6,412,583 shares of common stock ofImmunoCellular Therapeutics, Ltd. (17)

  4.14

  Certificate of Designations of Preferences, Rights and Limitations of Series A Preferred Stock dated December 3, 2009. (20)

  4.15

  Warrant dated December 3, 2009 issued by ImmunoCellular Therapeutics, Ltd. to Socius Capital Group, LLC d/b/a Socius Life Sciences Capital Group, LLC (20)

  4.16

  Amended Certificate of Designations of Preferences, Rights and Limitations of Series A Preferred Stock dated May 3, 2010. (22)

  4.17

  Form of Warrant issued to participants in the March 2010 private placement to purchase shares of common stock of ImmunoCellular Therapeutics, Ltd. (22)

  4.18

  Warrant dated May 2, 2010 for 1,350,000 shares issued by ImmunoCellular Therapeutics, Ltd. to Socius CG II, Ltd. (22)

  4.19

  Form of Warrant issued to participants in the February 2011 private placement to purchase shares of common stock of ImmunoCellular Therapeutics, Ltd. (26)

  5.1

  Opinion of TroyGould PC.**

10.1

  Exclusive License Agreement dated as of November 17, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd.† (8)

10.2

  First Amendment to Exclusive License Agreement dated as of June 16, 2008 2006, between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd.† (9)

10.3

  Stock Purchase Agreement dated as of November 17, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd. (8)

10.4

  Registration Rights Agreement dated as of November 17, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd. (8)

10.5

  Securities Purchase Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd. (8)

10.6

  Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd.* (8)

10.7

  Nonqualified Stock Option Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd.* (8)

10.8

  Registration Rights Agreement dated as of November 17, 2006 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd.(8)

 

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10.9  

  2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (4)

10.10

  Amendment No. 1 to the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (10)

10.11

  Amendment No. 2 to the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (11)

10.12

  Amendment No. 3 to the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (11)

10.13

  Amendment No. 4 to the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (9)

10.14

  Form of Non-Qualified Stock Option Agreement for the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (12)

10.15

  Form of Incentive Stock Option Agreement for the 2006 Equity Incentive Plan of ImmunoCellular Therapeutics, Ltd. (12)

10.16

  Employment Agreement dated as of February 18, 2008 between Dr. Manish Singh and ImmunoCellular Therapeutics, Ltd.* (11)

10.17

  Employment Agreement dated as of February 18, 2009 between Dr. Manish Singh and ImmunoCellular Therapeutics, Ltd.* (17)

10.18

  Employment Agreement dated as of November 5, 2007 between C. Kirk Peacock and ImmunoCellular Therapeutics, Ltd. (13)

10.19

  Employment Agreement dated as of October 30, 2008 between C. Kirk Peacock and ImmunoCellular Therapeutics, Ltd.* (17)

10.20

  Agreement dated as of July 7, 2006 between Technomedics Management & Systems, Inc. and ImmunoCellular Therapeutics, Ltd. (14)

10.21

  Agreement dated as of November 17, 2006 between Technomedics Management & Systems, Inc. and ImmunoCellular Therapeutics, Ltd.* (5)

10.22

  Memorandum of Agreement dated as of November 21, 2007 between Molecular Discoveries LLC and ImmunoCellular Therapeutics, Ltd. (11)

10.23

  Agreement dated as of February 14, 2008 between Molecular Discoveries, LLC and ImmunoCellular Therapeutics, Ltd. (11)

10.24

  Registration Rights Agreement dated as of April 14, 2008, between Molecular Discoveries, LLC and ImmunoCellular Therapeutics, Ltd. (15)

10.25

  Agreement dated as of February 14, 2008 between Dr. Cohava Gelber and ImmunoCellular Therapeutics, Ltd. (11)*

10.26

  Agreement dated as of August 1, 2008 between Dr. Cohava Gelber and ImmunoCellular Therapeutics, Ltd. * (17)

10.27

  Agreement dated as of September 1, 2008 between James G. Bender and ImmunoCellular Therapeutics, Ltd. (16) *

10.28

  Office lease dated April 28, 2008 between Regent Business Centers and ImmunoCellular Therapeutics, Ltd., as amended. (17)

10.29

  Amendment No. 1 to Agreement dated as of May 1, 2009 to Agreement dated October 30, 2008 between C. Kirk Peacock and ImmunoCellular Therapeutics, Ltd.*(18)

 

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10.30

  Second Amendment dated August 1, 2009 to Exclusive License Agreement dated as of November 1, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd.(19)

10.31

  Preferred Stock Purchase Agreement dated as of December 3, 2009 between ImmunoCellular Therapeutics, Ltd. and Socius Capital Group, LLC d/b/a Socius Life Sciences CapitalGroup, LLC. (20)

10.32

  Employment Agreement dated as of October 30, 2009 between C. Kirk Peacock and ImmunoCellular Therapeutics, Ltd. *(21)

10.33

  Employment Agreement dated as of February 1, 2010 between James G. Bender and ImmunoCellular Therapeutics, Ltd. * (27)

10.34

  Employment Agreement dated as of February 18, 2010 between Dr. Manish Singh and ImmunoCellular Therapeutics, Ltd. * (27)

10.35

  Agreement dated March 1, 2010 between Dr. John Yu and ImmunoCellular Therapeutics, Ltd. * (27)

10.36

  Securities Purchase Agreement dated March 29, 2010 between participants in the March 2010 private placement and ImmunoCellular Therapeutics, Ltd. (23)

10.37

  Form of Registration Rights Agreement dated as of March 29, 2010 between participants in the March 2010 private placement and ImmunoCellular Therapeutics, Ltd. (22)

10.38

  Agreement dated as of March 4, 2010 between Dr. Elma Hawkins and ImmunoCellular Therapeutics, Ltd.* (22)

10.39

  Office Lease dated April 1, 2010 between Regent Business Centers and ImmunoCellular Therapeutics, Ltd. (22)

10.40

  Modification Agreement dated May 2, 2010 among Socius CG II, Ltd., Socius Life Sciences Capital Group, LLC and ImmunoCellular Therapeutics, Ltd. (22)

10.41

  Third Amendment dated March 26, 2010 to Exclusive License Agreement dated as of November 1, 2006 between Cedars-Sinai Medical Center and ImmunoCellular Therapeutics, Ltd.(22)

10.42

  Securities Purchase Agreement dated May 12, 2010 between participants in the May 2010 private placement and ImmunoCellular Therapeutics, Ltd. (23)

10.43

  Form of Registration Rights Agreement between participants in the May 2010 private placement and ImmunoCellular Therapeutics, Ltd. (23)

10.44

  Employment Agreement dated as of October 30, 2010 between C. Kirk Peacock and ImmunoCellular Therapeutics, Ltd.* (24)

10.45

  Office Lease dated May 7, 2010 between Regent Business Centers and ImmunoCellular Therapeutics, Ltd. (23)

10.46

  Purchase Agreement, dated as of February 22, 2011, by and between the Company and each investor named therein. (26)

10.47

  Registration Rights Agreement, dated as of February 22, 2011, by and among the Company and the investors named therein. (26)

10.48

  Exclusive Sublicense Agreement dated May 28, 2010 between Targepeutics, Inc. and ImmunoCellular Therapeutics, Ltd. †(28)

 

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10.49

  Sponsored Research and Vaccine Production Agreement dated January 1, 2011 between The Trustees of the University of Pennsylvania and ImmunoCellular Therapeutics, Ltd. †(28)

10.50

  Placement agent agreement dated March 30, 2010 between Gilford Securities Incorporated and ImmunoCellular Therapeutics, Ltd. (28)

10.51

  

Placement agent agreement dated April 7, 2010 between Scarsdale Equities LLC and ImmunoCellular

Therapeutics, Ltd. (28)

10.52

  Consulting Agreement dated October 1, 2010 between JFS Investments and ImmunoCellular Therapeutics, Ltd. (28)

10.53

  Advisory services agreement dated October 1, 2010 between Garden State Securities Inc. and ImmunoCellular Therapeutics, Ltd. (28)

10.54

  Co-placement Agents Agreement dated January 31, 2011 among Summer Street Research Partners, Dawson James Securities, Inc. and ImmunoCellular Therapeutics, Ltd. (28)

23.1  

  Consent of Marcum LLP. **

23.2  

  Consent of Stonefield Josephson, Inc. **

23.3  

  Consent of TroyGould PC (included in Exhibit 5.1).

 

Certain portions of the exhibit have been omitted based upon a request for confidential treatment filed by us with the Securities and Exchange Commission. The omittedportions of the exhibit have been separately filed by us with the Securities and Exchange Commission.
*Indicates a management contract or compensatory plan or arrangement.
**Filed with this Registration Statement on Form S-1.
(1)Previously filed by us on January 26, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(2)Previously filed by us on November 3, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(3)Previously filed by us on May 9, 2007 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(4)Previously filed by us on February 6, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(5)Previously filed by us on February 12, 2007 as an exhibit to our Registration Statement on Form SB-2, File No. 333-140598, and incorporated herein byreference.
(6)Previously filed by us on May 1, 2007 as an exhibit to our Registration Statement on Form SB-2, File No. 333-142480, and incorporated herein by reference.
(7)Previously filed by us on July 12, 2007 as an exhibit to our Registration Statement on Form SB-2, File No. 333-144521, and incorporated herein by reference

 

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(8)Previously filed by us on November 22, 2006 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(9)Previously filed by us on August 14, 2008 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.
(10)Previously filed by us on September 14, 2007 as an exhibit to our Registration Statement on Form SB-2/A and incorporated herein by reference.
(11)Previously filed by us on March 25, 2008 as an exhibit to our Annual Report on Form 10-KSB and incorporated herein by reference.
(12)Previously filed by us on November 9, 2007 as an exhibit to our Registration Statement on Form S-8, File No. 333-147278, and incorporated herein by reference.
(13)Previously filed by us on November 6, 2007 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(14)Previously filed by us on April 2, 2007 as an exhibit to our Annual Report on Form 10-KSB and incorporated herein by reference.
(15)Previously filed by us on April 16, 2008 as an exhibit to our Registration Statement on Form S-1, File No. 333-150277, and incorporated herein by reference.
(16)Previously filed by us on November 13, 2008 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.
(17)Previously filed by us on March 30, 2009 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.
(18)Previously filed by us on August 14, 2009 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.
(19)Previously filed by us on November 13, 2009 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.
(20)Previously filed by us on December 7, 2009 as an exhibit to our Current Report on Form 8-K and incorporated herein by reference.
(21)Previously filed by us on December 23, 2009 as an exhibit to our Registration Statement on Form S-1 and incorporated herein by reference.
(22)Previously filed by us on May 12, 2010 as an exhibit to our Registration Statement on Form S-1 to SB-2, File No. 333-144521 and incorporated herein byreference.
(23)Previously filed by us on May 18, 2010 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.
(24)Previously filed by us on November 15, 2010 as an exhibit to our Quarterly Report on Form 10-Q and incorporated herein by reference.
(25)Previously filed by us on January 11, 2011 as an exhibit to our Registration Statement on Form S-8 and incorporated herein by reference.
(26)Previously filed by us on February 25, 2011 as an exhibit to our current report on Form 8-K and incorporated herein by reference.
(27)Previously filed by us on March 31, 2010 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.
(28)Previously filed by us on March 31, 2011 as an exhibit to our Annual Report on Form 10-K and incorporated herein by reference.

 

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