As filed with the Securities and Exchange Commissionon October 21, 2024

Registration No. 333-        

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1 

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

CERO THERAPEUTICS HOLDINGS, INC. 

(Exact name of registrant as specified in itscharter)

201 Haskins Way, Suite 230

South San Francisco, CA 94080

(215) 731-9450

(Address, including zip code, and telephonenumber, including area code, of registrant’s principal executive offices)

Chris Ehrlich

Interim Chief Executive Officer

CERo Therapeutics Holdings, Inc.

201 Haskins Way, Suite 230

South San Francisco, CA 94080

Telephone: (215) 731-9450 

(Name, address, including zip code, and telephonenumber, including area code, of agent for service)

Copies to:

Stephen M. Davis

Jeffrey A. Letalien

Goodwin Procter LLP

620 Eighth Avenue

New York, NY 10018

(212) 813-8800 

Approximate date of commencement of proposed sale to the public:From time to time after this Registration Statement becomes effective.

If any of the securities being registered on this Form are to be offeredon a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 check the following box: ☒

If this Form is filed to register additional securities for an offeringpursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number ofthe 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 list the Securities Act registration statement number of the earlier effective registrationstatement 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 list the Securities Act registration statement number of the earlier effective registrationstatement for the same offering. ☐

Indicate by check mark whether the registrant is a large acceleratedfiler, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of“large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growthcompany” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registranthas elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuantto Section 7(a)(2)(B) of the Securities Act. ☐ 

The registrant (the “Registrant”) hereby amends thisregistration statement (this “Registration Statement”) on such date or dates as may be necessary to delay its effective dateuntil the Registrant shall file a further amendment which specifically states that this Registration Statement shall thereafter becomeeffective in accordance with Section 8(a) of the Securities Act of 1933 or until this Registration Statement shall become effective onsuch date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

The information in this preliminary prospectus is not completeand may be changed. These securities may not be issued until the registration statement filed with the U.S. Securities and Exchange Commissionis effective. This preliminary prospectus is not an offer to sell these securities and does not constitute the solicitation of an offerto buy these securities in any jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION, DATED OCTOBER 21,2024

PRELIMINARY PROSPECTUS

CERO THERAPEUTICS HOLDINGS, INC.

Up to 713,563,749 Shares of Common Stock

This prospectus relates to the resale from timeto time by the selling securityholders named in this prospectus (collectively, the “Selling Securityholders”) or their permittedtransferees (after the expiration of any applicable lock-up period, assuming the satisfaction of any applicable vesting conditions andsubject to the beneficial ownership and stock exchange limitations described herein), of up to (i) 57,670,954 shares of common stock,par value $0.0001 per share (“Common Stock”), issuable upon the conversion of shares of our Series A Preferred Stock, parvalue $0.0001 per share (the “Series A Preferred Stock”), purchased by certain investors pursuant to the Amended and RestatedSecurities Purchase Agreement, dated as of February 14, 2024, by and among Legacy CERo, Phoenix Biotech Acquisition Corp. (“PBAX”)and such investors (the “First Securities Purchase Agreement”), at an effective purchase price of $0.0618 per share, resultingfrom the conversion of 125% of the number of outstanding shares of Series A Preferred Stock with a stated value of $1,000 per share, multipliedby certain adjustments set forth in the terms of the Series A Preferred Stock, and divided by a conversion price of $1.00 per share ofCommon Stock; (ii) 9,182,934 shares of Common Stock issuable upon the conversion of shares of our Series B Preferred Stock, par value$0.0001 per share (the “Series B Preferred Stock”) purchased by certain investors pursuant to the Securities Purchase Agreement,dated as of March 29, 2024, by and among us and such investors (the “Second Securities Purchase Agreement”), at an effectivepurchase price of $0.0618 per share, resulting from the conversion of 125% of the number of outstanding shares of Series B Preferred Stockwith a stated value of $1,000 per share, multiplied by certain adjustments set forth in the terms of the Series B Preferred Stock, anddivided by a conversion price of $1.00 per share of Common Stock; (iii) 70,739,367 shares of Common Stock issued upon the conversion ofshares of our Series A Preferred Stock and Series B Preferred Stock, at effective conversion prices ranging from $0.0647 to $0.2024; (iv)436,683,678 shares of Common Stock issuable upon the conversion of 300% of the number of outstanding shares of our Series C PreferredStock, par value $0.0001 per share (the “Series C Preferred Stock”), purchased by certain investors pursuant to the SecuritiesPurchase Agreement, dated as of September 25, 2024, by and among us and such investors (the “Third Securities Purchase Agreement”),at an effective purchase price of $0.0196, resulting from the conversion of shares of Series C Preferred Stock with a stated value of$1,000 per share, multiplied by certain adjustments set forth in the terms of the Series C Preferred Stock, and divided by a conversionprice of $0.20 per share of Common Stock; (v) 250,000 shares of Common Stock issued to a stockholder in a reallocation of shares in connectionwith the consummation of the Business Combination (as defined below), at an assumed purchase price of $5.85 per share, which was the closingprice of the Common Stock on the closing date of the Business Combination; and (vi) 75,000,000 shares of our Common Stock issuable toa service provider, issuable at a discount to the market price at the time of issuance, at an assumed purchase price of $0.02 per share.For more information about the Common Stock offered for resale by the Selling Securityholders pursuant to this prospectus, including thepurchase prices paid by such Selling Securityholders for their securities, see “Information Related to Offered Securities”beginning on page 9 of this prospectus.

This prospectus also relates to the resale bythe Selling Securityholders of up to (i) 8,175,166 shares of Common Stock issuable upon the exercise of warrants to purchase shares ofour Common Stock, at an exercise price of $0.098 per share, which warrants were sold to certain investors pursuant to the Third SecuritiesPurchase Agreement (the “Series C Warrants”); and (ii) 55,861,651 shares of Common Stock issuable upon the exercise of outstandingwarrants to purchase 125% of the number of shares of our Series A Preferred Stock at an effective exercise price of $1.39 per share ofSeries A Preferred Stock sold to certain investors pursuant to the First Securities Purchase Agreement (the “Preferred Warrants”)and conversion of the underlying shares of Series A Preferred Stock (the “Preferred Shares”) into Common Stock at a conversionprice of $0.0618 per share.

We could potentially receive (i) up to an aggregateof approximately $0.8 million in proceeds from the exercise of the Series C Warrants, assuming the exercise in full of all of the SeriesC Warrants for cash and (ii) up to an aggregate of approximately $2.0 million in proceeds from the exercise of the Preferred Warrants,assuming the exercise in full of all of the Series C Warrants and Preferred Warrants for cash. We will not receive any of the proceedsfrom the resale of the shares of Common Stock issuable upon the exercise of the Series C Warrants, or the resale of the shares of CommonStock issuable upon the exercise of the Preferred Warrants and conversion of the underlying shares of Series A Preferred Stock into CommonStock. We believe the likelihood that warrant holders will exercise their Series C Warrants or Preferred Warrants, and therefore the amountof cash proceeds that we would receive, is dependent upon the market price of our Common Stock. As further discussed in this prospectus,as of the date of this prospectus, most of our Warrants are “out of the money,” meaning the exercise price is higher thanthe market price of our Common Stock. Holders of such “out of the money” Warrants are not likely to exercise such Warrants.As a result, we have neither included nor intend to include any potential cash proceeds from the exercise of our Warrants in our short-termor long-term liquidity outlook and assumptions. We do not expect to rely on the exercise of our Warrants to fund our operations. We willcontinue to evaluate the probability of warrant exercise over the life of our Warrants and the merit of including potential cash proceedsfrom the exercise in our liquidity outlook and assumptions. As described more fully in the section of this prospectus titled “Management’sDiscussion and Analysis of Financial Condition and Results of Operations of CERo,” as a result of the high level of redemptionsin connection with the Business Combination, the funds released from PBAX’s trust account upon consummation of the Business Combinationhave also not been a meaningful source of liquidity. We expect to need to raise substantial capital or obtain other financing in orderto be able to meet our projected expenditures during the next 12 months following the date of this prospectus. If we are unable to raiseadditional funds through equity or debt financings when needed, we may be required to delay, limit, or substantially reduce our continuingoperations and growth strategy. See the section entitled “Risk Factors—Risks Related to Ownership of Our Securities.”

Due to the significant number of redemptions ofClass A common stock, par value $0.0001 per share (the “PBAX Class A common stock”), of PBAX in connection with the businesscombination (the “Business Combination”) pursuant to the Business Combination Agreement, dated as of June 4, 2023, as amendedfrom time to time (as amended, the “Business Combination Agreement”), by and among CERo Therapeutics, Inc. (“LegacyCERo”), PBAX and PBCE Merger Sub, Inc. (“Merger Sub”), there was a significantly lower number of shares of PBAX ClassA common stock that converted into shares of our Common Stock in connection with the Business Combination. As a result, the shares ofour Common Stock being registered for resale represent a considerable percentage of our public float, and the sales of such shares, orthe perception that these sales could occur, could cause the market price of the Common Stock to decline significantly. In addition, wewill not receive any proceeds from the resale of Common Stock by the Selling Securityholders pursuant to this prospectus. We expect torequire substantial additional capital to support our operations and execute our business plan, including the development and manufacturingof our product candidates, and the payment of deferred expenses incurred in connection with the Business Combination. We will be requiredto raise capital in part through the issuance of our equity or equity-based securities, the issuance of which may have an adverse effecton the price of our Common Stock. However, we may be unable to raise capital or additional financing when needed on acceptable terms,or at all. See the sections entitled “Information Related to Offered Securities” and “Risk Factors—RisksRelated to Ownership of Our Securities.”

We will pay the expenses, other than any underwritingdiscounts and commissions, associated with the resale of securities pursuant to this prospectus. The Selling Securityholders will bearall commissions and discounts, if any, attributable to their sales of the shares of Common Stock. We are registering the Selling Securityholders’securities for resale pursuant to the Selling Securityholders’ registration rights under the Registration Rights Agreement, datedas of February 14, 2024, by and among CERo and certain investors (the “First PIPE Registration Rights Agreement”), the RegistrationRights Agreement, dated as of March 29, 2024, by and among CERo and certain investors (the “Second PIPE Registration Rights Agreement”)and Registration Rights Agreement, dated as of September 26, 2024, by and among CERo and certain investors (the “Third PIPE RegistrationRights Agreement” and, together with the First PIPE Registration Rights Agreement and the Second PIPE Registration Rights Agreement,the “PIPE Registration Rights Agreements”). Our registration of the securities covered by this prospectus does not mean thatthe Selling Securityholders will offer or sell, as applicable, any of the securities. The Selling Securityholders may offer and sell thesecurities covered by this prospectus in a number of different ways and at varying prices. We provide more information about how the SellingSecurityholders may sell the shares in the section entitled “Plan of Distribution.”

This prospectus provides you with a general descriptionof such securities and the general manner in which the Selling Securityholders may offer or sell the securities. More specific terms ofany securities that the Selling Securityholders may offer or sell may be provided in a prospectus supplement that describes, among otherthings, the specific amounts and prices of the securities being offered and the terms of the offering. The prospectus supplement may alsoadd, update or change information contained in this prospectus.

You should read this prospectus and any prospectussupplement or amendment carefully before you invest in our securities.

Our Common Stock and public warrants to purchaseCommon Stock (the “Public Warrants”) are listed on Nasdaq Stock Market LLC (“Nasdaq”) under the symbol “CERO”and “CEROW,” respectively. On October 18, 2024, the closing price of our Common Stock was $0.0842 per share and theclosing price of our Public Warrants was $0.0048 per warrant.

We are an “emerging growth company”under applicable federal securities laws and are subject to reduced public company reporting requirements.

Investing in our securities involvesa high degree of risk. Before buying any securities, you should carefully read the discussion of the risks of investing in our securitiesin “Risk Factors” beginning on page 11 of this prospectus.

Neither the Securities and Exchange Commissionnor any state securities commission has approved or disapproved of the securities to be issued under this prospectus or determined ifthis prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The date of this prospectus is         ,2024.

TABLEOF CONTENTS

ABOUTTHIS PROSPECTUS

This prospectus is part of a registration statementon Form S-1 that we filed with the SEC whereby the Selling Securityholders named herein may, from time to time, sell the securitiesoffered by them described in this prospectus. We will not receive any proceeds from the sale by the Selling Securityholders of the securitiesoffered by them described in this prospectus. We will receive proceeds from any exercise of the Series C Warrants or Preferred Warrantsfor cash.

Neither we nor the Selling Securityholders haveauthorized anyone to provide you with any information or to make any representations other than those contained in this prospectus orany applicable prospectus supplement or any free writing prospectuses prepared by or on behalf of us or to which we have referred you.Neither we nor the Selling Securityholders take responsibility for, and can provide no assurance as to the reliability of, any other informationthat others may give you. Neither we nor the Selling Securityholders will make an offer to sell these securities in any jurisdiction wheresuch offer or sale is not permitted. No dealer, salesperson or other person is authorized to give any information or to represent anythingnot contained in this prospectus, any applicable prospectus supplement or any related free writing prospectus. You should assume thatthe information appearing in this prospectus or any prospectus supplement is accurate as of the date on the front of those documents only,regardless of the time of delivery of this prospectus or any applicable prospectus supplement, or any sale of a security. Our business,financial condition, results of operations and prospects may have changed since those dates.

The Selling Securityholders (and their permittedtransferees) may use this registration statement to sell securities from time to time through any means described in the sections titled“Plan of Distribution.” More specific terms of any securities that the Selling Securityholders offer and sell may beprovided in a prospectus supplement that describes, among other things, the specific amounts and prices of the securities being offeredand the terms of the offering.

We may also provide a prospectus supplement orpost-effective amendment to the registration statement to add information to, or update or change information contained in, this prospectus.Any statement contained in this prospectus will be deemed to be modified or superseded for purposes of this prospectus to the extent thata statement contained in such prospectus supplement or post-effective amendment modifies or supersedes such statement. Any statement somodified will be deemed to constitute a part of this prospectus only as so modified, and any statement so superseded will be deemed notto constitute a part of this prospectus. You should read both this prospectus and any applicable prospectus supplement or post-effectiveamendment to the registration statement together with the additional information to which we refer you in the sections of this prospectustitled “Where You Can Find More Information.”

This prospectus contains summaries of certainprovisions contained in some of the documents described herein, but reference is made to the actual documents for complete information.All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein havebeen filed or will be filed as exhibits to the registration statement of which this prospectus is a part, and you may obtain copies ofthose documents as described below under “Where You Can Find More Information.”

Certain monetary amounts, percentages and otherfigures included herein have been subject to rounding adjustments. Accordingly, figures shown as totals in certain tables and charts maynot be the arithmetic aggregation of the figures that precede them, and figures expressed as percentages in the text may not total 100%or, as applicable, when aggregated may not be the arithmetic aggregation of the percentages that precede them.

Unless the context otherwise requires, all referencesherein to “CERo,” “we,” “us,” or “our” refer to the business and operations of LegacyCERo and its consolidated subsidiaries prior to consummation of the Business Combination and to CERo and its consolidated subsidiariesfollowing the consummation of the Business Combination. “Legacy CERo” refers to CERo Therapeutics, Inc. prior to the consummationof the Business Combination.

MARKETAND INDUSTRY INFORMATION

Certain information contained in this documentrelates to or is based on studies, publications, surveys and other data obtained from third-party sources and our own internal estimatesand research. We believe these third-party sources to be reliable as of the date of this prospectus and we are responsible for such information.Such information and data involves risks and uncertainties and is subject to change based on various factors, including, potentially,those discussed under the section of this prospectus entitled “Risk Factors.” Furthermore, such information and datacannot always be verified with complete certainty due to limits on the availability and reliability of raw data, the voluntary natureof the data gathering process and other limitations and uncertainties inherent in any statistical survey. Additionally, while our owninternal research has not been verified by any independent source, we believe such research to be reliable and are responsible for anyinformation disclosed in this prospectus based upon such internal research.

TRADEMARKS

This document contains references to trademarksand service marks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectus may appearwithout the ® or ™ symbols, but such references are not intended to indicate, in any way, that the applicable licensor willnot assert, to the fullest extent under applicable law, its rights to these trademarks and trade names. We do not intend our use or displayof other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by,any other companies.

SELECTEDDEFINITIONS

As used in this prospectus, unless otherwise notedor the context otherwise requires, references to the following capitalized terms have the meanings set forth below:

“Arena” refers to Arena BusinessSolutions Global SPC II, Ltd. on behalf of and for the account of Segregated Portfolio #13 – SPC #13.

“Arena Commencement Date” refersto the time when all of the conditions to our right to commence sales of Common Stock to Arena set forth in the Arena Purchase Agreementhave been satisfied.

“Arena Commitment Shares” referto up to 1,000,000 shares of Common Stock issued to Arena as consideration for executing and delivering the Arena Purchase Agreement.

“Arena Equity Financing” refersto the equity line of credit established by the Arena Purchase Agreement.

“Arena Purchase Agreement”refers to the Purchase Agreement, dated as of February 23, 2024, by and between CERo and Arena.

“Arena Purchase Shares” refersto the $25.0 million of shares of Common Stock that Arena is obligated to purchase pursuant to the Arena Purchase Agreement.

“Board” refers to the boardof directors of CERo.

“Business Combination” refersto the transactions contemplated by the Business Combination Agreement, including the merger between Merger Sub and Legacy CERo.

“Business Combination Agreement”refers to the Business Combination Agreement, dated as of June 4, 2023, as amended by Amendment No. 1, dated February 5, 2024 and AmendmentNo. 2, dated February 13, 2024, by and between PBAX, Merger Sub and Legacy CERo.

“Bylaws” refers to the Amendedand Restated Bylaws of CERo.

“Charter” refers to CERo’sSecond Amended and Restated Certificate of Incorporation, as filed with the Secretary of the State of Delaware February 14, 2024.

“Closing” refers to the closingof the Business Combination.

“Closing Date” refers to February14, 2024.

“Common Stock” refersto the common stock, par value $0.0001 per share, of CERo.

“Common Warrants” refers tothe Public Warrants, Private Placement Warrants, the Conversion Warrants, the Series A Warrants and the Series C Warrants.

“Conversion Warrants” referto the warrants initially issued by CERo Therapeutics, Inc. and converted into warrants to purchase Common Stock in connection with theBusiness Combination.

“Convertible Bridge Notes”refer to the senior secured convertible notes issued by Legacy CERo to certain Legacy CERo Stockholders, which automatically convertedinto shares of Common Stock upon Closing.

“Danforth” refers to DanforthAdvisors, LLC.

“DGCL” refers to the DelawareGeneral Corporation Law, as may be amended from time to time.

“Distribution-in-Kind” refersto the Sponsor’s distribution of all of the shares of PBAX Class A Common Stock, Series A Preferred Stock and Private PlacementWarrants held thereby to its members immediately prior to the completion of the Business Combination.

“dollars” or “$”refers to U.S. dollars.

“Earnout Participants” referto the parties set forth on the Earn-out Allocation Schedule to the Business Combination Agreement.

“Earnout Shares” refer to thePrimary Earnout Shares, the Secondary Earnout Shares and the Tertiary Earnout Shares, collectively.

“Exchange Act” refers to theSecurities Exchange Act of 1934, as amended.

“Fee Modification Agreements”refers to the fee modification agreements between PBAX and certain third-party vendors and service providers, pursuant to which such vendorsreceived shares of Common Stock in lieu of certain payments due to such vendors prior to Closing.

“FDA” refers to the U.S. Foodand Drug Administration, or any successor agency thereto.

“First PIPE Financing” refersto the private placement pursuant to which we issued and sold, and the PIPE Investors purchased, shares of Series A Preferred Stock, theSeries A Warrants and Preferred Warrants, on the terms and conditions set forth in the First Securities Purchase Agreement.

“First PIPE Registration Rights Agreement”refers to the Registration Rights Agreement, dated as of February 14, 2024, by and between CERo and certain PIPE Investors.

“First Securities Purchase Agreement”refers to the Amended and Restated Securities Purchase Agreement, dated as of February 14, 2024, by and among PBAX, Legacy CERo and certainPIPE Investors, pursuant to which CERo agreed to issue and sell 10,039 shares of Series A Preferred Stock, 612,746 Series A Warrants and2,500 Preferred Warrants.

“Initial Public Offering” refersto the initial public offering of PBAX, which closed on October 8, 2021.

“Investor Rights Agreement”refers to the Investor Rights and Lock-up Agreement, dated February 14, 2024, by and among CERo, the Sponsor, certain Legacy CERo Stockholdersand certain other parties.

“Keystone” refers to KeystoneCapital Partners, LLC.

“Keystone Commencement Date”refers to the time when the time when all of the conditions to our right to commence sales of Common Stock to Keystone set forth in theKeystone Purchase Agreement have been satisfied. 

“Keystone Equity Financing”refers to the equity line of credit established by the Keystone Purchase Agreement.

“Keystone Purchase Agreement”refers to the Common Stock Purchase Agreement, dated as of February 14, 2024, by and between PBAX and Keystone.

“Keystone Purchase Shares”refers to the Common Stock that CERo may elect to issue and sell to Keystone after the Keystone Commencement Date.

“Keystone Registration Rights Agreement”refers to Registration Rights Agreement, dated as of February 14, 2024, by and between CERo and Keystone.

“Legacy CERo common stock”refers to the common stock, par value $0.0001 per share, of Legacy CERo.

“Legacy CERo preferred stock”refers to the preferred stock, par value $0.0001 per share, of Legacy CERo.

“Legacy CERo options” refersto the options to purchase shares of Legacy CERo common stock.

“Legacy CERo warrants” refersto the warrants to purchase shares of Legacy CERo preferred stock.

“Legacy CERo Stockholders”refer to the holders of Legacy CERo common stock and/or Legacy CERo preferred stock prior to the Business Combination.

“Liquidated Damages Modification Agreement”refers to the Liquidated Damages Modification Agreement, dated as of February 23, 2024, by and between us and Danforth.

“Merger Sub” refers to PBCEMerger Sub, Inc., a Delaware corporation.

“Nasdaq” refers to the NasdaqStock Market LLC.

“PBAX” refers to Phoenix BiotechAcquisition Corp., a Delaware corporation.

“PBAX Class A Common Stock”refers to the Class A common stock, par value $0.0001 per share, of PBAX.

“PIPE Financings” refers tothe First PIPE Financing, the Second PIPE Financing and the Third PIPE Financing.

“PIPE Investors” refer to theinvestors in the PIPE Financings.

“PIPE Registration Rights Agreement”refers to the First PIPE Registration Rights Agreement, the Second PIPE Registration Rights Agreement and the Third PIPE RegistrationRights Agreement.

“PIPE Warrants” refer to theSeries A Warrants, the Series C Warrants and the Preferred Warrants issued in the PIPE Financings.

“Preferred Stock” refers tothe shares of preferred stock, par value $0.0001 per share, of CERo.

“Preferred Shares” refer tothe shares of Series A Preferred Stock, Series B Preferred Stock and Series C Preferred Stock issued in the PIPE Financings, includingthe Warrant Preferred Shares.

“Preferred Warrants” referto warrants to purchase shares of Series A Preferred Stock.

“Primary Earnout Shares” referto the 1,200,000 shares of Common Stock issued to the holders of Legacy CERo common stock and Legacy CERo preferred stock in connectionwith the Business Combination, 1,000,000 of which are subject to vesting upon the achievement of certain stock price-based earnout targetsand 200,000 of which are subject to vesting upon a change of control, respectively.

“Private Placement Warrants”refer to private placement warrants to purchase shares of Common Stock, at an exercise price of $11.50 per share, that were originallysold in a private placement concurrently with the Initial Public Offering.

“Public Warrants” refer tothe warrants to purchase shares of Common Stock, at an exercise price of $11.50 per share, that were originally issued in the InitialPublic Offering.

“Rollover Warrants” refer towarrants to purchase shares of Common Stock, at an exercise price of $10.00 per share, that were converted from Legacy CERo warrants inconnection with the Business Combination.

“SEC” refers to the U.S. Securitiesand Exchange Commission.

“Secondary Earnout Shares”refer to the 875,000 shares of Common Stock issued to the holders of Legacy CERo common stock and Legacy CERo preferred stock in connectionwith the Business Combination, which became fully vested at Closing.

“Second PIPE Financing” refersto the private placement pursuant to which we issued and sold, and the PIPE Investors purchased, shares of Series B Preferred Stock, onthe terms and conditions set forth in the Second Securities Purchase Agreement.

“Second PIPE Registration Rights Agreement”refers to the Registration Rights Agreement, dated as of March 29, 2024, by and between CERo and certain PIPE Investors.

“Second Securities Purchase Agreement”refers to the Securities Purchase Agreement, dated as of March 29, 2024, by and among CERo and certain PIPE Investors, pursuant to whichCERo agreed to issue and sell 626 shares of Series B Preferred Stock.

“Securities Act” refers tothe Securities Act of 1933, as amended.

“Securities Purchase Agreements”refers to the First Securities Purchase Agreement, the Second Securities Purchase Agreement and the Third Securities Purchase Agreement.

“Selling Securityholders” hasthe meaning as described in the “Selling Securityholders” section of this prospectus.

“Series A Certificate of Designations”refers to the Certificate of Designations of Rights and Preferences of the Series A Preferred Stock, as amended from time to time.

“Series A Preferred Stock”refers to the Series A convertible preferred stock, $0.0001 par value per share, of CERo.

“Series A Warrants” refersto warrants to purchase Common Stock, at a current exercise price of $1.39 per share, sold to certain PIPE Investors pursuant to the FirstSecurities Purchase Agreement.

“Series B Certificate of Designations”refers to the Certificate of Designations of Rights and Preferences of the Series B Preferred Stock, as amended from time to time.

“Series B Preferred Stock”refers to the Series B convertible preferred stock, $0.0001 par value per share, of CERo.

 “Series C Certificate of Designations”refers to the Certificate of Designations of Rights and Preferences of the Series C Preferred Stock, as amended from time to time.

“Series C Preferred Stock”refers to the Series C convertible preferred stock, $0.0001 par value per share, of CERo.

“Series C Warrants” refersto warrants to purchase shares of Common Stock, at a current exercise price of $0.098 per share, sold to certain PIPE Investors pursuantto the Third Securities Purchase Agreement.

“Sponsor” refers to PhoenixBiotech Sponsor, LLC, a Delaware limited liability company.

“Tertiary Earnout Shares” referto the 1,000,000 shares of Common Stock issued to the holders of Legacy CERo common stock and Legacy CERo preferred stock in connectionwith the Business Combination, which will be fully vested upon the achievement of certain regulatory milestone-based earnout targets.

“Third PIPE Financing” refersto the private placement pursuant to which we issued and sold, and the PIPE Investors purchased, shares of Series C Preferred Stock, onthe terms and conditions set forth in the Third Securities Purchase Agreement.

“Third PIPE Registration Rights Agreement”refers to the Registration Rights Agreement, dated as of September 26, 2024, by and between CERo and certain PIPE Investors.

“Third Securities Purchase Agreement”refers to the Securities Purchase Agreement, dated as of September 25, 2024, by and among CERo and certain PIPE Investors, pursuant towhich CERo agreed to issue and sell 2,853 shares of Series C Preferred Stock and 8,175,166 Series C Warrants.

“Warrant Common Shares” referto the shares of Common Stock underlying the Common Warrants.

“Warrant Preferred Shares”refer to the shares of Preferred Stock underlying the Preferred Warrants.

“Warrants” refer to the RolloverWarrants, the Private Placement Warrants, the Common Warrants, the Preferred Warrants and the Public Warrants.

CAUTIONARYNOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus contains forward-looking statementswithin the meaning of Section 27A of the Securities Act, and Section 21E of the Securities Exchange Act. All statements other than statementsof historical facts contained in this prospectus, including statements regarding our future results of operations and financial position,business strategy, drug candidates, planned preclinical studies and clinical trials, results of preclinical studies, clinical trials,research and development (“R&D”) costs, regulatory approvals, timing and likelihood of success, as well as plans and objectivesof management for future operations, are forward-looking statements. These statements involve known and unknown risks, uncertainties andother important factors that are in some cases beyond our control and may cause our actual results, performance or achievements to bematerially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

In some cases, you can identify forward-lookingstatements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,”“anticipate,” “could,” “intend,” “target,” “project,” “believe,”“estimate,” “predict,” “potential,” or “continue” or the negative of these terms or othersimilar expressions. Forward-looking statements contained in this prospectus include, but are not limited to, statements about:

We have based these forward-looking statementslargely on our current expectations and projections about our business, the industry in which we operate and financial trends that webelieve may affect our business, financial condition, results of operations and prospects, and these forward-looking statements are notguarantees of future performance or development. These forward-looking statements speak only as of the date of this prospectus and aresubject to a number of risks, uncertainties and assumptions described in “Risk Factors” and elsewhere in this prospectus.Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified,you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in ourforward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-lookingstatements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements containedherein until after we distribute this prospectus, whether as a result of any new information, future events or otherwise.

In addition, statements that “we believe”and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information availableto us as of the date of this prospectus, and while we believe such information forms a reasonable basis for such statements, such informationmay be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, orreview of, all potentially available relevant information. These statements are inherently uncertain, and you are cautioned not to undulyrely upon these statements.

RISKFACTORS

Investing in our securities involves a highdegree of risk. Before you decide to invest in our securities, you should consider carefully the risks described below, together withthe other information contained in this prospectus, including our financial statements and the related notes appearing at the end of thisprospectus. We believe the risks described below are the risks that are material to us as of the date of this prospectus. If any of thefollowing risks actually occur, our business, results of operations and financial condition would likely be materially and adversely affected.In these circumstances, the market price of our securities could decline, and you may lose part or all of your investment.

Risks Related to this Offering by the Selling Securityholders

The shares of Common Stock being offered in this prospectus representa substantial percentage of the outstanding shares of Common Stock, and the sales of such shares, or the perception that these sales couldoccur, could cause the market price of the Common Stock to decline significantly.

Under this prospectus, the Selling Securityholderscan resell up to a total of 713,563,749 shares of Common Stock. The shares of Common Stock being offered for resale pursuant to thisprospectus by the Selling Securityholders would represent approximately 475% of the shares of Common Stock outstanding as of October8, 2024, assuming and after giving effect to the issuance of Common Stock upon exercise of all outstanding Preferred Warrants and themaximum number of shares of Common Stock issuable upon conversion of all outstanding Preferred Shares. Given the substantial number ofshares of Common Stock being registered pursuant to this prospectus, the sale of such shares, or the perception in the market of thepotential for the sale of a large number of shares, could increase the volatility of the market price of the Common Stock or result ina significant decline in the public trading price of the Common Stock.

Sales of a substantial number of our securities in the publicmarket by the Selling Securityholders and/or by our existing securityholders could cause the price of our Common Stock and Warrants tofall.

The securities being offered in this prospectusrepresent a substantial percentage of our outstanding shares of Common Stock and Warrants. Under this prospectus, the Selling Securityholderscan resell up to total of 713,563,749 shares of Common Stock.

Sales of a substantial number of shares of ourCommon Stock in the public market, including the resale of the shares held by the Selling Securityholders, could occur at any time (afterthe expiration of any applicable lock-up period, assuming the satisfaction of any applicable vesting conditions and subject to the beneficialownership and stock exchange limitations described herein). These sales, or the perception in the market that the holders of a large numberof shares of our Common Stock intend to sell shares, could increase the volatility of the market price of our Common Stock or result ina significant decline in the public trading price of our Common Stock. The shares of Common Stock being offered for resale pursuant tothis prospectus by the Selling Securityholders represent approximately 475% of shares of Common Stock outstanding as of October 8, 2024,assuming and after giving effect to the issuance of Common Stock upon exercise of all outstanding Common Warrants and Preferred Warrantsand the maximum number of shares of Common Stock issuable upon conversion of all outstanding Preferred Shares.

Under the terms of the Preferred Shares and thePIPE Warrants, a holder may not convert the Preferred Shares or exercise the PIPE Warrants to the extent (but only to the extent) suchSelling Securityholder or any of its affiliates would beneficially own a number of shares of Common Stock which would exceed 4.99%, or,at the election of the holder, a number of shares of Common Stock which would exceed 9.99%.

In addition, we are authorized to issue 1,000,000,000shares of Common Stock and, as of October 8, 2024, we had 150,307,957 shares of Common Stock issued and outstanding. The shares of CommonStock registered for resale pursuant to this prospectus, if issued, would exceed the number of shares of Common Stock authorized for issuance.In no event shall we effect any conversion of Preferred Shares or exercise of Warrants if such issuance would exceed the number of sharesof Common Stock authorized and available for issuance, except that such limitation shall not apply in the event that we obtain the approvalof our stockholders of the Reverse Stock Split.

On October 18, 2024, we filed a revised definitive proxy statementfor a special meeting of stockholders to seek approval of, among other things, (i) the issuance of shares of Common Stock upon conversionof shares of Series C Preferred Stock or exercise of Series C Warrants at conversion or exercise prices below the Minimum Price underNasdaq rules applicable as of the date of the Third Securities Purchase Agreement and (ii) a Reverse Stock Split. The primary objectiveof the Reverse Stock Split is to attempt to raise the per-share trading price of our common stock to meet Nasdaq’s listing requirements,including the Bid Price Requirement. The Reverse Stock Split, if approved, would have the effect of reducing the number of outstandingshares of our Common Stock without reducing the number of shares of available but unissued Common Stock, increasing the number of authorizedbut unissued shares of Common Stock.

After the registration statement of which thisprospectus forms a part is effective and until such time that it is no longer effective, it will permit the resale of these shares ofCommon Stock. The resale, or expected or potential resale, of a substantial number of shares of our Common Stock in the public marketcould adversely affect the market price for our Common Stock and make it more difficult for you to sell your holdings at times and pricesthat you determine are appropriate. Furthermore, we expect that, because there is a large number of shares of our Common Stock being registeredpursuant to the registration statement of which this prospectus forms a part, the Selling Securityholders thereunder will continue tooffer the securities covered thereby for a significant period of time, the precise duration of which cannot be predicted. Accordingly,the adverse market and price pressures resulting from an offering pursuant to the registration statement may continue for an extendedperiod of time. Sales of substantial number of such shares in the public market, including the resale of the shares of Common Stock heldby the Selling Securityholders, could adversely affect the market price of our Common Stock.

Certain existing securityholders purchased our securities ata price below the current trading price of such securities, and may experience a positive rate of return based on the current tradingprice. Future investors in us may not experience a similar rate of return.

Certain of our securityholders, including theSelling Securityholders, acquired our securities at prices below the current trading prices of our Common Stock and Public Warrants andmay experience a positive rate of return ranging from $0 to $0.078 based on the current trading prices, as illustrated in the sectiontitled “Information Related to Offered Securities.” In particular, the effective purchase prices at which certain LegacyCERo Stockholders and the Sponsor acquired their shares of our Common Stock are generally substantially less than the Initial Public Offeringprice of $10.00 per share, after giving effect to the Exchange Ratio (as defined in the Business Combination Agreement). Consequently,these securityholders may have an incentive to sell their shares of our Common Stock even if the trading price is below the price paidby investors in the Initial Public Offering, which could cause the market price of our Common Stock to decline. Such stockholders mayrealize a positive rate of return on the sale of their shares of Common Stock covered by this prospectus even if the market price pershare of our Common Stock is below $0.098 per share. On October 8, 2024, the closing prices of our Common Stock and our Public Warrantsas reported on the Nasdaq were $0.098 per share and $0.0087 per Public Warrant, respectively. While some of the Selling Securityholdersmay experience a positive rate of return based on the current trading price, public securityholders may not experience a similar rateof return on the securities they purchased due to differences in the purchase prices they paid and the trading price at the time of saleand may instead experience a negative rate of return on their investment.

Holders of our Warrants will be less likely toexercise their Warrants if the exercise prices of their Warrants exceed the market price of our Common Stock. There is no guarantee thatour Warrants will continue to be in the money prior to their expiration, and as such, the Warrants may expire worthless. As such, anycash proceeds that we may receive in relation to the exercise of the Warrants overlying shares of Common Stock being offered for salein this prospectus will be dependent on the trading price of our Common Stock. There is no assurance that the holders of the Warrantswill elect to exercise any or all of such Warrants. As of the date of this prospectus, (i) all of the Private Placement Warrants andPublic Warrants, which have an exercise price of $11.50 per share, (ii) all of the Rollover Warrants, which have an exercise price of$10.00 per share, and (iii) all of the Series A Warrants, which have a current exercise price of $1.39 per share, are “out of themoney,” meaning the exercise price is higher than the market price of our Common Stock. Holders of such “out of the money”Warrants are not likely to exercise such Warrants. There can be no assurance that such Warrants will be in the money prior to their respectiveexpiration dates, and therefore, we may not receive any cash proceeds from the exercise of such Warrants.

See the section titled “Information Relatedto Offered Securities” for more information.

In addition to this prospectus, we have filed:

In addition to any resales pursuant to such registrationstatements, subject to applicable transfer restrictions and the conditions to the availability of Rule 144 for former shell companiesunder Rule 144(i), shares of Common Stock held by these stockholders will be eligible for resale, potentially subject to, in the caseof stockholders who are our affiliates, volume, manner of sale, and other limitations under Rule 144 promulgated under the SecuritiesAct.

In addition, shares of our Common Stock issuableupon exercise or vesting of incentive awards under our incentive plans are, once issued, eligible for sale in the public market, subjectto any lock-up agreements and, in some cases, limitations on volume and manner of sale applicable to affiliates under Rule 144. Furthermore,shares of our Common Stock reserved for future issuance under our incentive plan may become available for sale in future.

The market price of shares of our Common Stockcould drop significantly if the holders of the shares of Common Stock described above sell them or are perceived by the market as intendingto sell them. These factors could also make it more difficult for us to raise additional funds through future offerings of shares of ourCommon Stock or other securities.

Risks Related to our Business and Industry

We have incurred significant losses in every year since our inception.We expect to continue to incur losses over the next several years and may never achieve or maintain profitability.

We are a preclinical stage biopharmaceutical companywith a limited operating history, and we have incurred significant net losses since our inception in 2016. We incurred net losses of approximately$7.3 million and $11.8 million for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, we had an accumulateddeficit of $43.1 million. We have funded our operations to date primarily with proceeds from the sale of our equity securities inprivate financing transactions.

We have no products approved for commercial saleand we are devoting, and expect to continue devoting, substantially all of our financial resources and efforts to R&D of our onlyprogrammed CER-T cell product candidate, CER-1236, as well as to building out our manufacturing infrastructure, CDMO relationships andCER-T cell programming technologies. Investment in biopharmaceutical product development, especially preclinical products, is highly speculativebecause it entails substantial upfront capital expenditures and significant risk that any potential product candidate will not successfullyundergo or complete necessary clinical trials, fail to demonstrate adequate effect or an acceptable safety profile, gain regulatory approvaland become commercially viable.

We expect that it could take several yearsuntil any of our product candidates, which at present is solely CER-1236, receive regulatory and marketing approval and are commercialized,and we may never be successful in obtaining regulatory and marketing approval and commercializing product candidates. We expect to continueto incur significant expenses and increasing operating losses for the foreseeable future. These net losses will adversely impact our stockholders’equity and net assets and may fluctuate significantly from quarter to quarter and year to year. We anticipate that our expenses will increasesubstantially as we:

To become and remain profitable, we must succeedin developing and eventually commercializing products that generate significant revenue. This will require us to be successful in a rangeof challenging activities, including completing preclinical studies and clinical trials for our product candidates, preparing a satisfactoryfiling package for regulatory authorities, obtaining regulatory approval, manufacturing, marketing and selling any products for whichwe may obtain regulatory approval, as well as discovering and developing additional product candidates. We may never succeed in theseactivities and, even if we do, may never generate revenues that are significant enough to achieve profitability.

Because of the numerous risks and uncertaintiesassociated with the development, manufacturing, delivery and commercialization of complex autologous cell therapies, we are unable toaccurately predict the timing or amount of expenses or when, or if, we will be able to achieve profitability. If we are required by regulatoryauthorities to perform studies in addition to those currently expected, or if there are any delays in the initiation and completion ofour clinical trials or the development of any of our product candidates, our expenses could increase and profitability could be furtherdelayed.

Even if we achieve profitability, we may not beable to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress thevalue of our securities and could impair our ability to raise capital, expand our business, maintain our R&D efforts or continue ouroperations. A decline in the value of our securities could also cause you to lose all or part of your investment.

Our independent registered public accountants have expressedsubstantial doubt as to our ability to continue as a going concern.

In its report on our financial statements forthe year ended December 31, 2023, our independent registered public accounting firm included an explanatory paragraph that expressed substantialdoubt about our ability to continue as a going concern. Our current cash level raises substantial doubt about our ability to continueas a going concern. In addition, our future financial statements may include similar qualifications about our ability to continue as agoing concern. Our financial statements were prepared assuming that we will continue as a going concern and do not include any adjustmentsthat may result from the outcome of this uncertainty. If we are unable to meet our current operating costs, we will need to seek additionalfinancing or modify or cease our operational plans. If we seek additional financing to fund our business activities in the future andthere remains substantial doubt about our ability to continue as a going concern, investors or other financing sources may be unwillingto provide additional funding to us on commercially reasonable terms or at all.

Our limited operating history makes it difficult to evaluateour business and assess our future viability and prospects.

We are a preclinical stage company with a limitedoperating history. We commenced operations in 2016, and our operations to date have been limited to organizing and planning our developmentefforts, raising capital, conducting discovery and research activities, filing patent applications, identifying potential product candidates,undertaking preclinical studies, and establishing arrangements with third parties for the manufacture of initial quantities of CER-1236and component materials. We have not yet demonstrated our ability to successfully complete any clinical trials, obtain regulatory approvals,manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales, marketing and distributionactivities necessary for successful product commercialization. Consequently, any predictions you make about our future success or viabilitymay not be as accurate as they could be if we had a longer operating history.

In addition, as a young business, we may encounterunforeseen expenses, difficulties, complications, delays and other known and unknown factors. We will need to transition at some pointfrom a company with a R&D focus to a company capable of supporting commercial activities. We may not be successful in such a transition.

We expect our financial condition and operatingresults to continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, many of which arebeyond our control. Accordingly, you should not rely upon the results of any quarterly or annual periods as indications of future operatingperformance.

Our business is highly dependent on the success of our lead productcandidate. If we are unable to advance clinical development, obtain approval of and successfully commercialize our lead product candidatefor the treatment of patients in approved indications, our business would be significantly harmed.

Our business and future success depends on ourability to advance clinical development, obtain regulatory approval of, and then successfully commercialize, CER-1236, our lead productcandidate. Because our CER-1236 product candidate will be among the first autologous T cell product candidates engineered with cytotoxicand phagocytic potency to be evaluated in clinical trials, the failure of such product candidate, or the failure of other autologous Tcell therapies, including for reasons due to safety, efficacy or durability, may impede our ability to develop our product candidates,and significantly influence physicians’ and regulators’ opinions with regard to the viability of our entire pipeline of autologousT cell therapies.

All of our product candidates, including our leadproduct candidate, will require additional preclinical, clinical and non-clinical development, regulatory review and approval in multiplejurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts beforewe can generate any revenue from product sales. In addition, because our other product candidates are based on similar technology as ourlead product candidate, if the lead product candidate encounters additional safety issues, efficacy problems, manufacturing problems,developmental delays, regulatory issues or other problems, our development plans and business would be significantly harmed.

We have not generated any revenue and may never be profitable.

Our ability to become profitable depends uponour ability to generate revenue. To date, we have not generated any revenue. We do not expect to generate significant revenue unless oruntil we successfully complete clinical development and obtain regulatory approval of, and then successfully commercialize, our productcandidates. We do not know when, or if, we will generate any revenue. All of our product candidates, including CER-1236, are in the preclinicalstages of development and will require additional preclinical studies, clinical development regulatory review and approval, substantialinvestment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generate any revenuefrom product sales. Our ability to generate revenue depends on a number of factors, including, but not limited to, our ability to:

Many of the factors listed above are beyond ourcontrol and could cause us to experience significant delays or prevent us from obtaining regulatory approvals or commercialize our productcandidates. Even if we are able to commercialize our product candidates, we may not achieve profitability soon after generating productsales, if ever. If we are unable to generate sufficient revenue through the sale of our product candidates or any future product candidates,we may be unable to continue operations without continued funding.

Our engineered CER-T cells represent a novel approach to cancertreatment that creates significant challenges for us.

We are developing autologous T-cell product candidatesthat are engineered from healthy donor T-cells to express chimeric engulfment receptors (“CERs”) and are intended for usein patients with certain cancers. Advancing these novel product candidates creates significant challenges for us, including:

Our preclinical programs may experience delays or may never advanceto clinical trials, which would adversely affect our ability to obtain regulatory approvals or to commercialize these programs on a timelybasis or at all, which would have an adverse effect on our business.

Our product candidates, including CER-1236, arein the preclinical development stage. The risk of failure of preclinical programs is high. Before we can commence clinical trials fora product candidate, we are nearing completion of extensive preclinical testing and studies to obtain regulatory clearance to initiatehuman clinical trials with CER-1236, and have engaged in a pre-IND meeting with the FDA. We expect that our clinical trials willbe conducted on populations based in the United States and Europe. We cannot be certain of the timely completion or outcome of ourpreclinical testing and studies and cannot predict if the FDA, the EMA or other regulatory authorities will accept our proposed clinicalprograms or if the outcome of our preclinical testing and studies will ultimately support the further development of our programs. Asa result, we cannot be sure that we will be able to submit INDs or similar applications for our clinical programs on the timelines weexpect, if at all.

Success in preclinical studies or clinical trials may not beindicative of results in future clinical trials.

Results from preclinical studies are not necessarilypredictive of future clinical trial results, and interim results of a clinical trial are not necessarily indicative of final results.Our product candidates may ultimately fail to show the desired safety and efficacy in clinical settings despite positive results in preclinicalstudies or having successfully advanced through initial clinical trials. This failure to establish sufficient efficacy and safety couldcause us to abandon clinical development of our product candidates.

Manufacturing genetically engineered products is complex andwe, or our third-party manufacturers, may encounter difficulties in production. If we or any of our third-party manufacturers encountersuch difficulties, our ability to provide supply of our product candidates for clinical trials or our products for patients, if approved,could be delayed or prevented.

Manufacturing genetically engineered productsis complex and may require the use of innovative technologies to handle living cells. Manufacturing these products requires facilitiesspecifically designed for and validated for this purpose and sophisticated quality assurance and quality control procedures are necessary.Slight deviations anywhere in the manufacturing process, including filling, labeling, packaging, storage and shipping and quality controland testing, may result in failures, product recalls or spoilage. When changes are made to the manufacturing process, we may be requiredto provide preclinical and clinical data showing the comparable identity, strength, quality, purity or potency of the products beforeand after such changes. If microbial, viral or other contaminations are discovered at manufacturing facilities, such facilities may needto be closed for an extended period of time to investigate and remedy the contamination, which could delay clinical trials and adverselyharm our business. The use of biologically derived ingredients can also lead to allegations of harm, including infections or allergicreactions, or closure of product facilities due to possible contamination.

In addition, there are risks associated with largescale manufacturing for clinical trials or commercial scale including, among others, cost overruns, potential problems with process scale-up,process reproducibility, stability issues, compliance with good manufacturing practices, lot consistency and timely availability of rawmaterials. Even if we obtain marketing approval for any of our product candidates, there is no assurance that we or our manufacturerswill be able to manufacture the approved product to specifications acceptable to the FDA, the EMA or other comparable foreign regulatoryauthorities, to produce it in sufficient quantities to meet the requirements for the potential commercial launch of the product or tomeet potential future demand. If we or our manufacturers are unable to produce sufficient quantities for clinical trials or for commercialization,our development and commercialization efforts would be impaired, which would have an adverse effect on our business, financial condition,results of operations and growth prospects.

Genetic engineering of T cells to create CER-T cells is a relativelynew technology, and if we are unable to use this technology in our intended product candidates, our revenue opportunities will be materiallylimited.

Our technology involves a relatively new approachto T cell gene therapy. This technology may also not be shown to be effective in clinical studies that we may conduct, or may be associatedwith safety issues that may negatively affect the development of our product candidates. For instance, lentiviral gene transduction maycreate unintended changes to the DNA such as a non-target site gene insertion, a large deletion, or a DNA translocation, any of whichcould lead to oncogenesis.

We may not be successful in our efforts to identify or discoveradditional product candidates.

The success of our business depends primarilyupon our ability to identify, develop and commercialize products based on our CER-T cell technology. Our research programs may fail toidentify other potential product candidates outside of CER-1236 for clinical development for a number of reasons. We may be unsuccessfulin identifying potential product candidates or our potential product candidates may be shown to have harmful side effects or may haveother characteristics that may make the products unmarketable or unlikely to receive marketing approval. Research programs to identifynew product candidates require substantial technical, financial and human resources. We may focus our efforts and resources on potentialprograms or product candidates that ultimately prove to be unsuccessful. If any of these events occur, we may be forced to abandon ourresearch, development or commercialization efforts for a program or programs, which would have a material adverse effect on our businessand could potentially cause us to cease operations.

Even if we obtain regulatory approval of a product candidate,the product may not gain market acceptance among physicians, patients, hospitals, cancer treatment centers and others in the medical community.

The use of engineered T cells as a potential cancertreatment is nascent and may not become broadly accepted by physicians, patients, hospitals, cancer treatment centers and others in themedical community. We expect physicians with expertise in immunotherapy to be particularly important to the market acceptance of our productsand we may not be able to educate them on the benefits of using our product candidates for many reasons. For example, certain of the productcandidates that we will be developing may result in unacceptable and unanticipated side effects, including death. Additional factors willinfluence whether our product candidates are accepted in the market, including:

If our product candidates are approved but failto achieve market acceptance among physicians, patients, hospitals, cancer treatment centers or others in the medical community, we willnot be able to generate significant revenue. Even if our products achieve market acceptance, we may not be able to maintain that marketacceptance over time if new products or technologies are introduced that are more favorably received than our products, are more costeffective or render our products obsolete.

Data from our preclinical studies is limited and may change aspatient data become available or may not be validated in any future or advanced clinical trial.

Data from preclinical studies and any clinicaltrials that we may complete is subject to the risk that one or more of the clinical outcomes may materially change as patient enrollmentcontinues and more patient data becomes available. For example, preclinical and Phase 1 results are preliminary in nature and shouldnot be viewed as predictive of ultimate success. It is possible that such results will not continue or may not be repeated in any clinicaltrial of our product candidates. For instance, our preclinical studies provide limited data and any clinical trials may not validate suchresults. Additionally, manufacturing can impact clinical outcomes and we have not yet completed manufacturing runs with a CDMO. Wemay also fail to develop and transfer to a CDMO any optimized manufacturing processes for any of our programs. Ultimately, if we cannotmanufacture our product candidates with consistent and reproducible product characteristics, our ability to develop and commercializeany product candidate would be significantly impacted.

Preliminary data also remains subject to auditand verification procedures that may result in the final data being materially different from the preliminary data we previously published.As a result, initial, interim and preliminary data should be viewed with caution until the final data are available. Adverse differencesbetween preliminary or interim data and final data could significantly harm our business prospects.

We may not be able to file INDs or IND amendments to commenceclinical trials on the timelines we expect, and even if we are able to, the FDA may not permit us to proceed.

We may not be able to file INDs, including theIND for CER-1236, on the timelines we expect. For example, we may experience manufacturing delays or other delays with IND-enabling studies.Moreover, we cannot be sure that submission of an IND will result in the FDA allowing clinical trials to begin, or that, once begun, issueswill not arise that suspend or terminate clinical trials. Additionally, even if such regulatory authorities agree with the design andimplementation of the clinical trials set forth in an IND, we cannot guarantee that such regulatory authorities will not change theirrequirements in the future. These considerations also apply to new clinical trials we may submit as amendments to existing INDs.

Clinical trials are difficult to design and implement, involveuncertain outcomes and may not be successful.

Human clinical trials are difficult to designand implement, in part because they are subject to rigorous regulatory requirements. The design of a clinical trial can determine whetherits results will support approval of a product, and flaws in the design of a clinical trial may not become apparent until the clinicaltrial is well advanced. We may be unable to design and execute a clinical trial that will be successful to achieve regulatory approval.There is a high failure rate for biological products proceeding through clinical trials, which may be higher for our product candidatesbecause they are based on new technology and engineered on a patient-by-patient basis. Many companies in the pharmaceutical and biotechnologyindustries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in preclinical testingand earlier-stage clinical trials. Data obtained from preclinical and clinical activities are subject to varying interpretations, whichmay delay, limit or prevent regulatory approval. In addition, we may experience regulatory delays or rejections as a result of many factors,including changes in regulatory policy during the period of our product candidate development. Any such delays could negatively impactour business, financial condition, results of operations and prospects.

We will depend on enrollment of patients in our clinical trialsfor our product candidates. If we encounter difficulties enrolling patients in our clinical trials, our clinical development activitiescould be delayed or otherwise adversely affected.

Identifying and qualifying patients to participatein clinical trials of our product candidates will be critical to our success. We may experience difficulties in patient enrollment inour clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with their protocols depends, amongother things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion. The enrollment ofpatients depends on many factors, including:

In particular, some of our clinical trials willlook to enroll patients with characteristics which are found in a very small population. For example, our clinical trial for CER-1236will seek to enroll patients with hematologic malignancies, including AML, MCL, CLL, and other B cell and myeloid neoplasms. Othercompanies are conducting clinical trials with their engineered T cell therapies in hematologic malignancies and seek to enroll patientsin their studies that may otherwise be eligible for our clinical trials, which could lead to slow recruitment and delays in our clinicaltrials. In addition, since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trialsat the same clinical trial sites that some of our competitors use, which could further reduce the number of patients who are availablefor our clinical trials in these clinical trial sites.

Moreover, because our product candidates representa departure from more commonly used methods for cancer treatment, potential study participants and their doctors may be inclined to useconventional therapies, such as chemotherapy and antibody therapy, rather than participate in our clinical trials.

Delays in patient enrollment may result in increasedcosts or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these clinical trials andadversely affect our ability to advance the development of our product candidates. In addition, many of the factors that may lead to adelay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our productcandidates.

If the market opportunities for any of our product candidatesare smaller than we believe they are, our revenue may be adversely affected, and our business may suffer.

We are focused initially on the development oftreatments for cancers such as AML, MCL and CLL, and plan to eventually extend our treatments to other forms of cancer. Our internal projectionsof addressable patient populations that have the potential to benefit from treatment with our product candidates are based on estimates.If any of our estimates are inaccurate, the market opportunities for any of our product candidates could be significantly diminished andhave an adverse material impact on our business.

We currently have no marketing and sales organization and haveno experience in marketing products. If we are unable to establish marketing and sales capabilities or enter into agreements with thirdparties to market and sell our product candidates, if licensed, we may not be able to generate product revenue.

We currently have no sales, marketing or distributioncapabilities and have no experience in marketing products. We intend to develop an in-house marketing organization and sales force, whichwill require significant capital expenditures, management resources and time. We will have to compete with other pharmaceutical and biotechnologycompanies to recruit, hire, train and retain marketing and sales personnel.

If we are unable or decide not to establish internalsales, marketing and distribution capabilities, we will pursue collaborative arrangements regarding the sales and marketing of our productcandidates following their approval. However, there can be no assurance that we will be able to establish or maintain such collaborativearrangements, or if we are able to do so, that they will have effective sales forces. Any revenue we receive will depend upon the effortsof such third parties, which may not be successful. We may have little or no control over the marketing and sales efforts of such thirdparties and our revenue from product sales may be lower than if we had commercialized our product candidates ourselves. We also face competitionin our search for third parties to assist us with the sales and marketing efforts of our product candidates.

There can be no assurance that we will be ableto develop in-house sales and distribution capabilities or establish or maintain relationships with third-party collaborators to commercializeany product in the United States or overseas.

We face competition from companies that have developed or maydevelop product candidates for the treatment of the diseases that we may target, including companies developing novel therapies and platformtechnologies. If these companies develop platform technologies or product candidates more rapidly than we do, if their platform technologiesor product candidates are more effective or have fewer side effects, our ability to develop and successfully commercialize product candidatesmay be adversely affected.

The development and commercialization of celland gene therapies Is highly competitive. We compete with a variety of large pharmaceutical companies, multinational biopharmaceuticalcompanies, other biopharmaceutical companies and specialized biotechnology companies, as well as technology and/or therapeutics beingdeveloped at universities and other research institutions. Our competitors are often larger and better funded than we are. Our competitorshave developed, are developing or will develop product candidates and processes competitive with ours. Competitive therapeutic treatmentsinclude those that have already been approved and accepted by the medical community and any new treatments that are currently in developmentor that enter the market. We believe that a significant number of product candidates are currently under development, and may become commerciallyavailable in the future, for the treatment of conditions for which we may try to develop product candidates. There is intense and rapidlyevolving competition in the biotechnology and biopharmaceutical fields. We believe that while our T-cell based platform, its associatedintellectual property portfolio, the characteristics of our current and potential future product candidates and our scientific and technicalknow-how together give us a competitive advantage in this space, competition from many sources remains.

Many of our competitors have significantly greaterfinancial, technical, manufacturing, marketing, sales and supply resources or experience than we do. If we successfully obtain approvalfor any product candidate, we will face competition based on many different factors, including the safety and effectiveness of our productcandidates, the ease with which our product candidates can be administered, the timing and scope of regulatory approvals for these productcandidates, the availability and cost of manufacturing, marketing and sales capabilities, price, reimbursement coverage and patent position.Competing products and product candidates could present superior treatment alternatives, including by being more effective, safer, lessexpensive or marketed and sold more effectively than any products we may develop. Competitive products and product candidates may makeany product we develop obsolete or noncompetitive before we recover the expense of developing and commercializing such product. Such competitorscould also recruit our employees, which could negatively impact our level of expertise and our ability to execute our business plan.

These competitors also compete with us in recruitingand retaining qualified scientific and management personnel and establishing clinical study sites and patient registration for clinicalstudies, as well as in acquiring technologies complementary to, or necessary for, our programs. Smaller or early-stage companies may alsoprove to be significant competitors, particularly through collaborative arrangements with large and established companies.

Our commercial opportunity could be reduced oreliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects,are more convenient or are less expensive or better reimbursed than any products that we may commercialize. Our competitors also may obtainFDA, EMA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in ourcompetitors establishing a strong market position for either the product or a specific indication before we are able to enter the market.

We are highly dependent on our key personnel, including individualswith expertise in cell therapy development and manufacturing, and if we are not successful in attracting and retaining highly qualifiedpersonnel, we may not be able to successfully implement our business strategy.

Our ability to compete in the highly competitivebiotechnology and pharmaceutical industries depends upon our ability to attract and retain highly qualified managerial, scientific andmedical personnel. We are highly dependent on the expertise of our management, scientific and medical personnel, including our chief executiveofficer (“Chief Executive Officer”), Brian G. Atwood, our chief technical officer, Daniel Corey, and the head of our scientificadvisory board (the “Scientific Advisory Board”), Lawrence Corey. The loss of the services of any of our executive officers,other key employees, and other scientific and medical advisors, and our inability to find suitable replacements could result in delaysin product development and harm our business.

We conduct substantially all of our operationsat our facilities in the South San Francisco area. The San Francisco Bay Area region is headquarters to many other biopharmaceutical companiesand many academic and research institutions. Competition for skilled personnel in our market is intense and may limit our ability to hireand retain highly qualified personnel on acceptable terms or at all. Attrition may lead to higher costs for hiring and retention, diversionof management time to address retention matters and disrupt the business.

To induce valuable employees to remain at ourcompany, in addition to salary and cash incentives, we have provided equity-based compensation for retention purposes. Despite our effortsto retain valuable employees, members of our management, scientific and development teams may terminate their employment with us on shortnotice. Although we have employment agreements with our key employees, these employment agreements provide for at-will employment, whichmeans that any of our employees could leave our employment at any time, with or without notice. We do not maintain “key person”insurance policies on the lives of these individuals or the lives of any of our other employees. Our success also depends on our abilityto continue to attract, retain and motivate highly skilled junior, mid-level and senior managers as well as junior, mid-level and seniorscientific and medical personnel.

We will need to continue to grow the size of our organization,and we may experience difficulties in managing this growth.

As our development, manufacturing and commercializationplans and strategies develop, we expect to add managerial, operational, sales, R&D, marketing, financial and other personnel. Currentand future growth imposes and will impose significant added responsibilities on members of management, including:

Our future financial performance and our abilityto commercialize our product candidates will depend, in part, on our ability to effectively manage our growth, and our management mayalso have to divert a disproportionate amount of its attention away from day-to-day activities in order to devote a substantial amountof time to managing these growth activities.

We currently rely, and for the foreseeable futurewill continue to rely, in substantial part on certain independent organizations, advisors and consultants. There can be no assurance thatthe services of independent organizations, advisors and consultants will continue to be available to us on a timely basis when needed,or that we can find qualified replacements. We may also be subject to penalties or other liabilities if we mis-classify employees as consultants.In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracy of the services provided byconsultants is compromised for any reason, our clinical trials may be extended, delayed or terminated, and we may not be able to obtainregulatory approval of our product candidates or otherwise advance our business. There can be no assurance that we will be able to manageour existing consultants or find other competent outside contractors and consultants on economically reasonable terms, or at all.

If we are not able to effectively expand our organizationby hiring and retaining employees and expanding our groups of consultants and contractors, we may not be able to successfully implementthe tasks necessary to further develop, manufacture and commercialize our product candidates and, accordingly, may not achieve our research,development, manufacturing and commercialization goals. Conversely, if we expand ahead of our business progress, we may take on unnecessarycosts.

We may form or seek strategic alliances or enter into licensingarrangements in the future, and we may not realize the benefits of such alliances or licensing arrangements.

We may form or seek strategic alliances, createjoint ventures or collaborations or enter into licensing arrangements with third parties that we believe will complement or augment ourdevelopment and commercialization efforts with respect to our product candidates and any future product candidates that we may develop.Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures, issuesecurities that dilute our existing stockholders or disrupt our management and business. In addition, we face significant competitionin seeking appropriate strategic partners and the negotiation process is time-consuming and complex. Moreover, we may not be successfulin our efforts to establish a strategic partnership or other alternative arrangements for our product candidates because they may be deemedto be at too early of a stage of development for collaborative effort and third parties may not view our product candidates as havingthe requisite potential to demonstrate safety and efficacy. Any delays in entering into strategic partnership agreements related to ourproduct candidates could delay the development and commercialization of our product candidates in certain geographies for certain indications,which would harm our business prospects, financial condition and results of operations.

If we license products or new technologies oracquire businesses, we may not be able to realize the benefit of such transactions if we are unable to successfully integrate them withour existing operations and company culture. For instance, certain of our agreements may require significant R&D that may not resultin the development and commercialization of product candidates. We cannot be certain that, following a strategic transaction or license,we will achieve the results, revenue or specific net income that justifies such transaction.

We will need substantial additional financing to develop ourproduct candidates and implement our operating plans, which financing we may be unable to obtain, or unable to obtain on acceptable terms.If we fail to obtain additional financing, we may be unable to complete the development and commercialization of our product candidates.

We expect to spend a substantial amount of capitalin the development and manufacturing of our product candidates, and we will need substantial additional financing to do so. In particular,we will require substantial additional financing to enable commercial production of our product candidates and initiate and complete registrationaltrials for multiple products in multiple regions. Further, if approved, we will require significant additional capital in order to launchand commercialize our product candidates.

As of September 30, 2024, we had approximately$3.3 million in cash and cash equivalents. Changing circumstances may cause us to consume capital significantly faster than we currentlyanticipate, and we may need to spend more money than currently expected because of circumstances beyond our control. We may also needto raise additional capital sooner than we currently anticipate if we choose to expand more rapidly than we presently plan. In any event,we will require additional capital for the further development and commercialization of our product candidates, including funding ourinternal manufacturing capabilities.

We cannot be certain that additional funding willbe available on acceptable terms, or at all. We have no committed source of additional capital. If we are unable to raise additional capitalin sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercializationof our product candidates or other R&D initiatives. We could be required to seek collaborators for our product candidates at an earlierstage than otherwise would be desirable or on terms that are less favorable than might otherwise be available or relinquish or licenseon unfavorable terms our rights to our product candidates in markets where we otherwise would seek to pursue development or commercializationourselves.

Any of the above events could significantly harmour business, prospects, financial condition and results of operations and cause the price of our Common Stock to decline.

Raising additional capital may cause dilution to our stockholders,restrict our operations or require us to relinquish rights to our product candidates.

Until such time, if ever, as we can generate substantialrevenue from the sale of our product candidates, we will need substantial additional financing to develop our product candidates and implementour operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownershipinterest will be diluted, and the terms of these securities may include liquidation or other preferences that could adversely affect yourrights as a common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include covenantslimiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaringdividends.

If we raise additional funds through collaborations,strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuablerights to our research programs or product candidates or grant licenses on terms that may not be favorable to us or that may be at lessthan the full potential value of such rights. If we are unable to raise additional funds through equity or debt financings or other arrangementswith third parties when needed, we may be required to delay, limit, reduce or terminate our drug development or future commercializationefforts or grant rights to third parties to develop and market product candidates that we would otherwise prefer to develop and marketourselves.

The issuance of shares of our Common Stock upon conversion orexercise of our outstanding Preferred Shares and Common Warrants and other securities that we may issue in future financing transactionsmay result in substantial dilution to our stockholders.

As of the date of this prospectus, the Companycurrently has outstanding (i) 3,075 shares of Series A Preferred Stock with a conversion value of approximately $3.8 million, convertibleinto shares of Common Stock at a conversion rate of the stated value thereof divided by a current effective conversion price of $0.07416;(ii) 486 shares of Series B Preferred Stock with a conversion value of approximately $0.6 million, convertible into shares of Common Stockat a conversion rate of the stated value thereof divided by a current effective conversion price of $0.07416; (iii) 2,853 shares of SeriesC Preferred Stock with a stated value of approximately $2.9 million, convertible into shares of Common Stock at a conversion rate of thestated value thereof divided by a conversion price of $0.022; (iv) 1,962 Preferred Warrants to purchase shares of Series A Preferred Stockat an exercise price of $1,000, which would result in Series A Preferred Stock with a conversion value of approximately $2.5 million,convertible into shares of Common Stock at a conversion rate of the stated value thereof divided by a current effective conversion priceof $0.07416; (v) 612,746 Series A Warrants to purchase shares of Common Stock at an exercise price of $1.39 per share; (vi) 8,175,166Series C Warrants to purchase shares of Common Stock at an exercise price of $0.098; and (vii) 9,879,858 Public Warrants and Private PlacementWarrants to purchase shares of Common Stock at exercise prices ranging from $9.20 to $11.50 per share. As of the date of this prospectus,holders of 7,069 shares of Series A Preferred Stock, 140 shares of Series B Preferred Stock and 38 Preferred Warrants have converted suchshares into an aggregate of approximately 110.9 million shares of Common Stock.

Although each of the conversion price of the PreferredShares and the exercise price of the Series A Preferred Warrants are at or above the trading price of our Common Stock asof the date of this prospectus, if such trading price increases, such conversion prices and exercise price will not change as a resultthereof and could be below the trading price of our Common Stock as of the date of any future conversion or exercise thereof, resultingin dilution to our stockholders. In addition, the terms of the Series A Preferred Stock, the Series B Preferred Stock and the Series CPreferred Stock contain certain penalties and adjustments to the amount included in determination of the conversion rate following certainbreaches of the Company’s obligations thereunder, including, among other things, as a result of a failure to file or cause the SECto declare one or more registration statements relating to the resale of the shares of Common Stock issuable upon conversion thereof byspecified deadlines, certain defaults under indebtedness of the Company or judgments against the Company and failure to deliver sharesof Common Stock upon conversion in a timely manner. For example, the penalties and adjustments include a 25% premium added to the statedvalue for determining the conversion rate in connection with breaches other than the breach of the requirement to redeem the shares ofSeries A Preferred Stock and Series B Preferred Stock by August 14, 2025, which results in a 50% premium, and the addition to the statedvalue of an amount equal to the value of the shares of Common Stock into which the Series A Preferred Stock or Series B Preferred Stockwould have been convertible if the conversion price were equal to 80% of the lowest volume weighted average price during the five tradingdays immediately prior to conversion. Such penalties and adjustments, which applied during the period when all of the conversions sincethe Business Combination described in the preceding paragraph occurred as a result of a failure to file and cause the SEC to declare aregistration statement with respect to the resale of the underlying shares in a timely manner, have resulted and may in the future resultin the issuance of shares of Common Stock at an effective conversion price below the trading price of our Common Stock at the time ofsuch conversion.

We cannot assure you that we will remain in compliancewith all of the terms of the Series A Preferred Stock, Series B Preferred Stock or Series C Preferred Stock and that such penalties andadjustments will not apply in the future. In addition, we cannot assure you that we will not issue additional convertible or other derivativesecurities with highly dilutive penalty or adjustment provisions. As described elsewhere in this report, the Company needs to obtain financingto fund its research and development activities and, if the IND is accepted, clinical trials, as well as other operations. Under challengingconditions in the equity capital markets, particularly for pre-commercialization biotech companies, we may have no viable alternativesto agreeing to inclusion of such provisions in the terms of future financings.

If our security measures, or those of our CROs, CDMOs, collaborators,contractors, consultants or other third parties upon whom we rely, are compromised or the security, confidentiality, integrity or availabilityof our information technology, software, services, networks, communications or data is compromised, limited or fails, we could experiencea material adverse impact.

In the ordinary course of our business, we maycollect, process, receive, store, use, generate, transfer, disclose, make accessible, protect, secure, dispose of, transmit, and share(collectively processing) proprietary, confidential and sensitive information, including personal data (including health information),intellectual property, trade secrets, and proprietary business information owned or controlled by ourselves or other parties. We may alsoshare or receive sensitive information with our partners, CROs, CDMOs, or other third parties. Our ability to monitor these third parties’information security practices is limited, and these third parties may not have adequate information security measures in place. If we(or a third party upon whom we rely) experience a security incident or are perceived to have experienced a security incident, we may alsoexperience adverse consequences.

Our internal computer systems and those of ourCROs, CDMOs, collaborators, contractors, consultants or other third parties are vulnerable to damage from computer viruses, unauthorizedaccess, cybersecurity threats, and telecommunication and electrical failures. In addition, as many of our personnel work from home atleast part of the time and utilize network connections outside our premises, this poses increased risks to our information technologysystems and data. Cyberattacks, malicious internet-based activity, and online and offline fraud are prevalent and are increasing in theirfrequency, sophistication and intensity, and have become increasingly difficult to detect. These threats come from a variety of sources,including traditional computer “hackers,” “hacktivists,” organized criminal threat actors, threat actors, personnel(such as through theft or misuse), sophisticated nation-states, and nation-state-supported actors. Some actors now engage and are expectedto continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical reasons and in conjunction withmilitary conflicts and defense activities. During times of war and other major conflicts, we, and the third parties upon which we rely,may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, that could materially disrupt our systemsand operations, supply chain, and ability to produce and distribute our product candidates. We and the third parties upon which we relyare subject to a variety of evolving threats, including social-engineering attacks (including through phishing attacks), malicious code(such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service (such as credentialstuffing), credential harvesting, social engineering attacks (including through phishing attacks), viruses, ransomware, supply chain attacks,personnel misconduct or error and other similar threats. We may also be the subject of software bugs, server malfunction, software orhardware failures, loss of data or other information technology assets, adware, telecommunications failures or other similar issues. Inparticular, ransomware attacks are becoming increasingly prevalent and severe and can lead to significant interruptions, delays, or outagesin our operations, disruptions to our clinical trials, loss of data (including data related to clinical trials), significant expense torestore data or systems, reputational loss and the diversion of funds. Extortion payments may alleviate the negative impact of a ransomwareattack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments.Similarly, supply chain attacks have increased in frequency and severity, and we cannot guarantee that third parties and infrastructurein our supply chain have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach toour information technology systems or the third-party information technology systems that support us and our services. Future or pastbusiness transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities, asour systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies.Furthermore, we may discover security issues that were not found during due diligence of such acquired or integrated entities, and itmay be difficult to integrate companies into our information technology environment and security program.

Any of the previously identified or similar threatscould cause a security incident or other interruption. A security incident or other interruption could result in unauthorized, unlawful,or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to our sensitive information.A security incident or other interruption could disrupt our ability (and that of third parties upon whom we rely) to manufacture or deliverour product candidates.

We may expend significant resources, or modifyour business activities and operations, including our clinical trial activities, in an effort to protect against security incidents. Certaindata privacy and security obligations may require us to implement and maintain specific security measures or use industry-standard orreasonable security measures to protect our information technology systems and sensitive information.

Although we have implemented security measuresdesigned to protect against security incidents, there can be no assurance that these measures will be effective. We have experienced attemptsto compromise our information technology systems or otherwise cause a security incident, but, to our knowledge, such attempts have beenunsuccessful. In addition, from time to time, our vendors inform us of security incidents. To date, our review of such incidents as reportedto us did not reveal material information being lost, CERo-specific security vulnerabilities or provide any useful information or insightinto our systems or environment. However, we may not have all information related to such incidents and future incidents could have anadverse impact on our business.

We may be unable to detect vulnerabilities inour information technology systems because such threats and techniques change frequently, are often sophisticated in nature, and may notbe detected until after a security incident has occurred. Despite our efforts to identify and remediate exploitable critical vulnerabilities,if any, in our information technology systems, our efforts may not be successful. Further, we may experience delays in developing anddeploying remedial measures designed to address any such identified vulnerabilities. Any failure to prevent or mitigate security incidentsor improper access to, use of, or disclosure of our clinical data or patients’ personal data could result in significant liabilityunder state, federal, and international law and may cause a material adverse impact to our reputation, affect our ability to conduct ourclinical trials and potentially disrupt our business.

Applicable data protection laws, privacy policiesand data protection obligations may require us to notify relevant stakeholders of security incidents. Such disclosures are costly, andthe disclosures or the failure to comply with such requirements could lead to adverse consequences. If we (or a third party upon whomwe rely) experience a security incident or are perceived to have experienced a security incident, we may also experience adverse consequences.These consequences may include: government enforcement actions (for example, investigations, fines, penalties, audits, and inspections);additional reporting requirements and/or oversight; restrictions on processing sensitive information (including personal data); litigation(including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions; interruptionsin our operations (including availability of data); financial loss; and other similar harms.

Our contracts may not contain limitations of liability,and even where they do, there can be no assurance that the limitations of liability in our contracts are sufficient to protect us fromliabilities, damages, or claims related to our data privacy and security obligations.

We cannot be sure that our insurance coveragewill be adequate or sufficient to protect us from or adequately mitigate liabilities arising out of our privacy and security practices,or that such coverage will continue to be available on commercially reasonable terms or at all, or that such coverage will pay futureclaims.

Disruptions at the FDA, the SEC and other government agenciescaused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel,prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performingnormal business functions on which the operation of our business may rely, which could negatively impact our business.

The ability of the FDA to review and approve newproducts can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personneland accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the agency have fluctuatedin recent years as a result. In addition, government funding of the SEC and other government agencies on which our operations mayrely, including those that fund R&D activities is subject to the political process, which is inherently fluid and unpredictable.

Disruptions at the FDA and other agencies mayalso slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affectour business. For example, over the last several years the U.S. government has shut down several times and certain regulatoryagencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities.If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatorysubmissions, which could have a material adverse effect on our business. Further, in our operations as a public company, future governmentshutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continueour operations.

Since March 2020, when foreign and domesticinspections of facilities were largely placed on hold, the FDA has been working to resume pre-pandemic levels of inspection activities,including routine surveillance, bioresearch monitoring and pre-approval inspections. Should the FDA determine that an inspection is necessaryfor approval and an inspection cannot be completed during the review cycle due to restrictions on travel or otherwise, and the FDA doesnot determine a remote interactive evaluation to be adequate, the FDA has stated that it generally intends to issue, depending on thecircumstances, a complete response letter or defer action on the application until an inspection can be completed.

Business disruptions, including financial institution distress,could seriously harm our future revenue and financial condition and increase our costs and expenses.

Our operations, and those of our CROs, CDMOs andother contractors and consultants, could be subject to earthquakes, power shortages, telecommunications failures, water shortages, floods,hurricanes, typhoons, fires, extreme weather conditions, medical pandemics or epidemics and other natural or man-made disasters or businessinterruptions. The occurrence of any of these business disruptions could seriously harm our operations and financial condition and increaseour costs and expenses. Our ability to obtain clinical supplies of our product candidates could be disrupted if the operations of thesesuppliers are affected by a man-made or natural disaster or other business interruption.

Our employees, independent contractors, consultants, commercialpartners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

We are exposed to the risk of employee fraud orother illegal activity by our employees, independent contractors, consultants, commercial partners and vendors. Misconduct by these partiescould include intentional, reckless and/or negligent conduct that fails to comply with the regulations of the FDA and other similar foreignregulatory authorities, provide true, complete and accurate information to the FDA and other similar foreign regulatory authorities, complywith manufacturing standards we have established, comply with healthcare fraud and abuse laws in the United States and similar foreignfraudulent misconduct laws or report financial information or data accurately or to disclose unauthorized activities to us. If we obtainFDA approval of any of our product candidates and begin commercializing those products in the United States, our potential exposure undersuch laws and regulations will increase significantly, and our costs associated with compliance with such laws and regulations are alsolikely to increase. These laws may impact, among other things, our current activities with principal investigators and research patients,as well as proposed and future sales, marketing and education programs. In particular, the promotion, sales and marketing of healthcareitems and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to preventfraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing,discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangementsgenerally. For more information, see the section entitled “Business– Healthcare Laws and Regulations.”

The distribution of biotechnology and biopharmaceuticalproducts is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirementsintended to prevent the unauthorized sale of biotechnology and biopharmaceutical products.

The scope and enforcement of each of these lawsis uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicableprecedent and regulations. Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible investigationsby government authorities, can be time- and resource-consuming and can divert a company’s attention from other aspects of its business.

It is not always possible to identify and deteremployee misconduct, and our code of ethics and the other precautions we take to detect and prevent inappropriate conduct may not be effectivein controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuitsstemming from a failure to be in compliance with such laws or regulations.

Efforts to ensure that our business arrangementswith third parties will comply with applicable healthcare laws and regulations will involve substantial costs. Because of the breadthof these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activitiescould be subject to challenge under one or more of such laws. It is possible that governmental authorities will conclude that our businesspractices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcarelaws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that mayapply to us, we may be subject to significant criminal, civil and administrative sanctions including monetary penalties, damages, fines,disgorgement, diminished profits and future earnings, individual imprisonment, and exclusion from participation in government funded healthcareprograms, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporate integrityagreement or similar agreement to resolve allegations of non-compliance with these laws, reputational harm, and we may be required tocurtail or restructure our operations, any of which could adversely affect our ability to operate our business and our results of operations.

The shifting compliance environment and the needto build and maintain robust and expandable systems to comply with multiple jurisdictions with different compliance and/or reporting requirementsincreases the possibility that a healthcare company may run afoul of one or more of the requirements. Any action against us for violationof these laws, even if we successfully defend against it, could cause us to incur significant legal expenses and divert our management’sattention from the operation of our business.

The provision of benefits or advantages to physiciansto induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is also prohibitedin the European Union. The provision of benefits or advantages to induce or reward improper performance generally is typically governedby the national anti-bribery laws of European Union Member States, and in respect of the U.K. (which is longer a member of the EuropeanUnion), the U.K. Bribery Act 2010. Infringement of these laws could result in substantial fines and imprisonment. European UnionDirective 2001/83/EC, which is the European Union Directive governing medicinal products for human use, further provides that, where medicinalproducts are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages or benefits in kind may besupplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine or pharmacy. This provisionhas been transposed into the Human Medicines Regulations 2012 and so remains applicable in the UK despite its departure from the EuropeanUnion. Payments made to physicians in certain European Union Member States must be publicly disclosed. Moreover, agreements with physiciansoften must be the subject of prior notification and approval by the physician’s employer, his or her competent professional organizationand/or the regulatory authorities of the individual European Union Member States. These requirements are provided in the national laws,industry codes or professional codes of conduct, applicable in the European Union Member States. Failure to comply with these requirementscould result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

The collection, use, disclosure, transfer, orother processing of personal data regarding individuals in the European Union, including personal health data, is subject to the EuropeanUnion General Data Protection Regulation (“GDPR”), which became effective on May 25, 2018, as well as the United Kingdom’sGeneral Data Protection Regulations (the “UK GDPR”), which, together with the amended UK Data Protection Act 2018, retainsthe GDPR in UK national law. The GDPR is wide-ranging in scope and imposes numerous requirements on companies that process personal data,including requirements relating to processing health and other sensitive data, obtaining consent of the individuals to whom the personaldata relates, providing information to individuals regarding data processing activities, implementing safeguards to protect the securityand confidentiality of personal data, providing notification of data breaches, and taking certain measures when engaging third-party processors.The GDPR also imposes strict rules on the transfer of personal data to countries outside the European Union, including the United States,and permits data protection authorities to impose large penalties for violations of the GDPR, including potential fines of up to €20 millionor 4% of annual global revenues, whichever is greater; UK GDPR mirrors such fines under the GDPR. The GDPR also confers a privateright of action on data subjects and consumer associations to lodge complaints with supervisory authorities, seek judicial remedies, andobtain compensation for damages resulting from violations of the GDPR. Compliance with the GDPR will be a rigorous and time-intensiveprocess that may increase our cost of doing business or require us to change our business practices, and despite those efforts, thereis a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with European activities. Thisand other future developments regarding the flow of data across borders could increase the cost and complexity of delivering our productcandidates, if approved, in some markets and may lead to governmental enforcement actions, litigation, fines and penalties or adversepublicity, which could have an adverse effect on our reputation and business. 

Our product candidates may cause undesirable side effects orhave other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potentialor result in significant negative consequences.

Future undesirable or unacceptable side effectscaused by our product candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could resultin a more restrictive label or the delay or denial of regulatory approval by the FDA or other comparable foreign regulatory authorities.Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics.Approved autologous T cell therapies and those under development by other companies have shown frequent rates of CRS, neurotoxicity, seriousinfections, prolonged cytopenia and hypogammaglobulinemia, and adverse events have resulted in the death of patients. Similar adverseevents may occur for our T cell product candidates.

In addition, we utilize a lymphodepletion regimen,which generally includes fludarabine, cyclophosphamide or bendamustine, that may cause serious adverse events. For instance, because theregimen will cause a transient and sometimes prolonged immune suppression, patients will have an increased risk of infection, such asto COVID-19, that may be unable to be cleared by the patient and ultimately lead to other serious adverse events or death. Our lymphodepletionregimen has caused and may also cause prolonged cytopenia and aplastic anemia.

We may also combine the use of our product candidateswith other investigational or approved therapies that may cause separate adverse events or events related to the combination or potentiateside effects of approved drugs.

If unacceptable toxicities arise in the developmentof our product candidates, we could suspend or terminate our trials or the FDA, the EMA or comparable foreign regulatory authorities couldorder us to cease clinical trials or deny approval of our product candidates for any or all targeted indications. Any data safety monitoringboard may also suspend or terminate a clinical trial at any time on various grounds, including a finding that the research patients arebeing exposed to an unacceptable health risk, including risks inferred from other unrelated immunotherapy trials. Treatment-related sideeffects could also affect patient recruitment or the ability of enrolled subjects to complete the trial or result in potential productliability claims. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff, as toxicitiesresulting from T cell therapy are not normally encountered in the general patient population and by medical personnel. Inadequate trainingin recognizing or managing the potential side effects of our product candidates could result in patient deaths. Any of these occurrencesmay harm our business, financial condition and prospects significantly.

Our product candidates may target healthy cells expressing targetantigens, leading to potentially fatal adverse effects.

Our product candidates target specific antigensthat are also expressed on healthy cells. For example, cell surface phosphatidylserine, the target of CER-1236, has been observed on activatedimmune cells, including platelets, and in rapidly dividing cells across various organs including the gastrointestinal system, hepaticsystem, cardiovascular system, renal system, pulmonary system, and the central nervous system and related peripheral nervous system. Ourproduct candidates may target healthy cells, leading to serious and potentially fatal adverse effects. Even though we intend to closelymonitor the side effects of our product candidates in both preclinical studies and clinical trials, we cannot guarantee that productswill not target and kill healthy cells.

Our product candidates may have serious and potentially fatalcross-reactivity to lipids, peptides or protein sequences within the body.

Our product candidates may recognize and bindto a peptide unrelated to the target antigen to which it is designed to bind. If this peptide is expressed within normal tissues, ourproduct candidates may target and kill the normal tissue in a patient, leading to serious and potentially fatal adverse effects. Additionally,our product candidates may bind with non-targeted lipids, leading to off-target reactivity. Detection of any on-target off-tumor or non-specific-reactivitymay halt or delay any ongoing clinical trials for any CER-T cell based product candidate and prevent or delay regulatory approval. Unknownbinding-reactivity of the CER-T cell binding domain to related proteins could also occur. Any non-specific binding interactions that impactspatient safety could materially impact our ability to advance our product candidates into clinical trials or to proceed to marketing approvaland commercialization.

If product liability lawsuits are brought against us, we mayincur substantial liabilities and may be required to limit commercialization of our product candidates.

We face an inherent risk of product liabilityas a result of the planned clinical testing of our product candidates and will face an even greater risk if we commercialize any products.For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable duringclinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing,defects in design, packaging, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties.Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liabilityclaims, we may incur substantial liabilities or be required to limit commercialization of our product candidates. Even successful defensewould require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may resultin:

Failure to obtain or retain sufficient productliability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercializationof products we develop, alone or with corporate collaborators. Although we plan on purchasing clinical trial insurance, such insurancepolicies also have various exclusions, and we may be subject to a product liability claim for which we have no coverage. We may have topay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance,and we may not have, or be able to obtain, sufficient capital to pay such amounts. Even if our agreements with any future corporate collaboratorsentitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise.

Public opinion and scrutiny of cell-based immune-oncology therapiesfor treating cancer, or negative clinical trial results from our cell-based therapy competitors, or auto-immune cell therapy candidates,may impact public perception of our company and product candidates, or impair our ability to conduct our business.

Our autologous cell therapy platforms utilizesa relatively novel technology involving the genetic modification of cells, and no CER-T cell-based immunotherapy has been approved todate. Public perception may be influenced by claims, such as claims that cell-based immunotherapy is unsafe, unethical, or immoral and,consequently, our approach may not gain the acceptance of the public or the medical community. Negative public reaction to cell-basedimmunotherapy in general, or negative clinical trial results from our cell-based therapy competitors, or auto-immune cell therapy candidates,could result in greater government regulation and stricter labeling requirements of cell-based immunotherapy products, including any ofour product candidates, and could cause a decrease in the demand for any products we may develop. Adverse public attitudes may adverselyimpact our ability to enroll patients in clinical trials. More restrictive government regulations or negative public opinion could havean adverse effect on our business or financial condition and may delay or impair the development and commercialization of our productcandidates or demand for any products we may develop.

For example, in November 2023, the FDA announcedthat it would be conducting an investigation into reports of T-cell malignancies following BCMA-directed or CD19-directed autologous CAR-Tcell immunotherapies following reports of T cell lymphoma in patients receiving these therapies. In January 2024, the FDA determined thatnew safety information related to T cell malignancies should be included in the labeling with boxed warning language on these malignanciesfor all BCMA- and CD-19-directed genetically modified autologous T cell immunotherapies. While CER-1236 and our engineered CER-Tcells are designed to utilize a different mechanism of action, FDA’s investigation into CAR-T therapies and other similaractions could result in increased government regulation, unfavorable public perception and publicity, potential impacts on enrollmentin our clinical trials, potential regulatory delays in the testing or approval of our product candidates, stricter labeling requirementsfor those product candidates that are approved, and a decrease in demand for any such product candidates.

Our product candidates for which we intend to seek approval asbiological products may face competition sooner than anticipated, including from other therapeutic modalities.

The Affordable Care Act, signed into law on March 23,2010, includes a subtitle called the BPCIA, which created an abbreviated approval pathway for biological products that are biosimilarto or interchangeable with an FDA-licensed reference biological product. Under the BPCIA, an application for a biosimilar product maynot be submitted to the FDA until four years following the date that the reference product was first licensed by the FDA. Inaddition, the approval of a biosimilar product may not be made effective by the FDA until 12 years from the date on which the referenceproduct was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the referenceproduct if the FDA approves a full BLA for the competing product containing the sponsor’s own preclinical data and data from adequateand well-controlled clinical trials to demonstrate the safety, purity and potency of their product.

We believe that any of our product candidatesapproved as a biological product under a BLA should qualify for the 12-year period of exclusivity. However, there is a risk that thisexclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our product candidates to bereference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated. Otheraspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. Moreover,the extent to which a biosimilar, once approved, will be substituted for any one of our products in a way that is similar to traditionalgeneric substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatory factors thatare still developing.

If any approved products are subject to biosimilarcompetition sooner than we expect, we will face significant pricing pressure and our commercial opportunity will be limited.

The insurance coverage and reimbursement status of newly-approvedproducts is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new products could limit our product revenues.

Our ability to commercialize any of our productcandidates successfully will depend in part on the extent to which reimbursement for these products and related treatments will be availablefrom government health administration authorities, private health insurers, and other organizations. In the United States, the principaldecisions about reimbursement for new therapies are typically made by CMS, an agency within the United States Department of Healthand Human Services. CMS decides whether and to what extent a new therapy will be covered and reimbursed under Medicare, and private payorstend to follow CMS determinations to a substantial degree. The availability and extent of reimbursement by governmental and private payorsis essential for most patients to be able to afford expensive treatments, such as cellular immunotherapy. There is significant uncertaintyrelated to the insurance coverage and reimbursement of newly approved products by government and third-party payors. In particular, thereis no body of established practices and precedents for reimbursement of cellular immunotherapies, and it is difficult to predict whatthe regulatory authority or private payor will decide with respect to reimbursement levels for novel products such as ours. Our productcandidates may not qualify for coverage or direct reimbursement, or may be subject to limited reimbursement. If reimbursement or insurancecoverage is not available, or is available only to limited levels, we may not be able to successfully commercialize our product candidates,if approved. Even if coverage is provided, the approved reimbursement amount may not be sufficient to allow us to establish or maintainpricing to generate income.

In addition, reimbursement agencies in foreignjurisdictions may be more conservative than those in the United States. Accordingly, in markets outside the United States, thereimbursement for our product candidates, if approved, may be reduced as compared with the United States and may be insufficientto generate commercially reasonable revenues and profits. Moreover, increasing efforts by governmental and third-party payors, in theUnited States and abroad, to cap or reduce healthcare costs may cause such organizations to limit both coverage and level of reimbursementfor new products approved, and as a result, they may not cover or provide adequate payment for our product candidates. Failure to obtainor maintain adequate reimbursement for any products for which we receive marketing approval will adversely affect our ability to achievecommercial success, and could have a material adverse effect on our operating results, our ability to raise capital needed to commercializeproducts, and our overall financial condition.

Even if we obtain regulatory and marketing approval for a productcandidate, our product candidates will remain subject to regulatory oversight.

Even if we receive marketing and regulatory approvalfor CER-1236 or any other product candidates, regulatory authorities may still impose significant restrictions on the indicated uses ormarketing or impose ongoing requirements for potentially costly post-approval studies. CER-1236 and other product candidates will alsobe subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping,and submission of safety and other post-market information. The FDA has significant post-market authority, including, for example, theauthority to require labeling changes based on new safety information and to require post-market studies or clinical trials to evaluateserious safety risks related to the use of a biologic. Any regulatory approvals that we receive for CER-1236 or other product candidatesmay also be subject to a REMS, limitations on the approved indicated uses for which the product may be marketed or to the conditions ofapproval, or contain requirements for potentially costly post-marketing testing, including post-approval clinical trials, and surveillanceto monitor the quality, safety, and efficacy of the product, all of which could lead to lower sales volume and revenue. For example, theholder of an approved BLA is obligated to monitor and report adverse events and any failure of a product to meet the specifications inthe BLA. The holder of an approved BLA also must submit new or supplemental applications and obtain FDA approval for certain changesto the approved product, product labeling, or manufacturing process. Advertising and promotional materials must comply with FDA rulesand are subject to FDA review, in addition to other potentially applicable federal and state laws.

In addition, product manufacturers and their facilitiesare subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliancewith cGMP requirements and adherence to commitments made in the BLA or foreign marketing application. If we, or a regulatory authority,discover(s) previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problemswith the facility where the product is manufactured or disagrees with the promotion, marketing or labeling of that product, a regulatoryauthority may impose restrictions relative to that product, the manufacturing facility or us, including requiring recall or withdrawalof the product from the market or suspension of manufacturing.

If we or our contractors fail to comply with applicableregulatory requirements following approval of CER-1236 or our other product candidates, a regulatory authority may:

Any government investigation of alleged violationsof law could require us to expend significant time and resources in response and could generate negative publicity. The occurrence ofany event or penalty described above may inhibit our ability to commercialize CER-1236 or other product candidates and adversely affectour business, financial condition, results of operations, and prospects.

Prior treatments can alter the cancer or target of CER-T celltherapy and negatively impact chances for achieving clinical activity with our programmed T cells.

Patients with hematological cancers receive highlytoxic lympho-depleting chemotherapy as their initial treatment. These therapies can impact the viability of the T cells collected fromthe patient and can contribute to highly variable responses to programmed T cell therapies. Patients could also have received prior therapiesthat target the same target antigen on the cancer cells as our intended programmed T cell product candidate and thereby lead to a selectionof cancer cells with low or no expression of the target. Cancers also naturally evolve and select clones with low or no expression ofthe target. As a result, our programmed T cell product candidates may not recognize the cancer cell and may fail to achieve clinical activity.If any of our product candidates do not achieve a sufficient level of clinical activity, we may discontinue the development of that productcandidate, which could adversely affect our business, financial condition, results of operations, and prospects.

Risks Related to Reliance on Third-Parties

We will rely on third parties to conduct our clinical trials.If these third parties do not properly and successfully carry out their contractual duties or meet expected deadlines, we may not be ableto obtain regulatory approval of or commercialize our product candidates.

We expect to utilize and depend upon independentinvestigators and collaborators, such as medical institutions, CROs, CDMOs and strategic partners to conduct our preclinical studies underagreements with us and in connection with our clinical trials. We expect to have to negotiate budgets and contracts with CROs, trial sitesand CDMOs which may result in delays to our development timelines and increased costs. We will rely heavily on these third parties overthe course of our clinical trials and we control only certain aspects of their activities. As a result, we have less direct control overthe conduct, timing and completion of these clinical trials and the management of data developed through clinical trials than would bethe case if we were relying entirely upon our own staff. Nevertheless, we are responsible for ensuring that each of our studies is conductedin accordance with applicable protocol, legal and regulatory requirements and scientific standards and our reliance on third parties doesnot relieve us of our regulatory responsibilities. We and these third parties are required to comply with GCPs, which are regulationsand guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates in clinical development. Regulatoryauthorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any ofthese third parties fail to comply with applicable GCP regulations, the clinical data generated in our clinical trials may be deemed unreliableand the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketingapplications. We cannot assure you that, upon inspection, such regulatory authorities will determine that any of our clinical trials complywith the GCP regulations. In addition, our clinical trials must be conducted with biological product produced under cGMP regulations,including current good tissue practice (“cGTP”) regulations, and will require a large number of test patients. Our failureor any failure by these third parties to comply with these regulations or to recruit a sufficient number of patients may require us torepeat clinical trials, which would delay the regulatory approval process. Moreover, our business may be implicated if any of these thirdparties violates federal or state fraud and abuse or false claims laws and regulations or healthcare privacy and security laws.

Any third parties conducting our clinical trialsare not and will not be our employees and, except for remedies available to us under our agreements with such third parties, we cannotcontrol whether or not they devote sufficient time and resources to our product candidates. These third parties may also have relationshipswith other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug developmentactivities, which could affect their performance on our behalf. If these third parties do not successfully carry out their contractualduties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data theyobtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our clinicaltrials may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatory approval of or successfullycommercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates wouldbe harmed, our costs could increase and our ability to generate revenue could be delayed.

Switching or adding third parties to conduct ourclinical trials involves substantial cost and requires extensive management time and focus. In addition, changes in manufacturers ofteninvolve changes in manufacturing procedures and processes, which could require that we conduct bridging studies between our prior clinicalsupply used in our clinical trials and that of any new manufacturer. We may be unsuccessful in demonstrating the comparability of clinicalsupplies which could require the conduct of additional clinical trials. Additionally, there is a natural transition period when a newthird party commences work. As a result, delays occur, which can materially impact our ability to meet our desired clinical developmenttimelines.

We rely on third parties to manufacture and store our clinicalproduct supplies, and we may have to rely on third parties to produce and process our product candidates, if approved. There can be noassurance that we will be able to establish or maintain relationships with such third parties. We may in the future establish our ownmanufacturing facility and infrastructure in addition to or in lieu of relying on third parties for the manufacture of our product candidates,which would be costly, time-consuming and which may not be successful.

Our product candidates are manufactured in theUnited States by third parties, and we manage all other aspects of the supply, including planning, oversight, disposition and distributionlogistics. There can be no assurance that we will not experience supply or manufacturing issues in the future.

We have a long-term agreement in place with aCDMO for the manufacture of CER-1236. However, we have not yet caused our product candidates to be manufactured or processed on a commercialscale and may not be able to achieve manufacturing and processing and may be unable to create an inventory of mass-produced product tosatisfy demands for any of our product candidates. Our clinical supply will also be limited to small quantities and any latent defectsdiscovered in our supply could significantly delay our development timelines.

In addition, our actual and potential future relianceon a limited number of third-party manufacturers exposes us to the following risks:

Our contract manufacturers would also be subjectto the same risks we face in developing our own manufacturing capabilities, as described above. Our current and potential future CDMOsmay also be required to shut down in response to the spread of health epidemics or pandemics, or they may prioritize manufacturing fortherapies or vaccines for other diseases. In addition, our CDMOs have certain responsibilities for storage of raw materials and in thepast have lost or failed to adequately store our raw materials. We will also rely on third parties to store our released product candidates,and any failure to adequately store our product candidates could result in significant delay to our development timelines. Any additionalor future damage or loss of raw materials or product candidates could materially impact our ability to manufacture and supply our productcandidates. Each of these risks could delay our clinical trials, the approval, if any of our product candidates by the FDA or the commercializationof our product candidates or result in higher costs or deprive us of potential product revenue.

In addition, we will rely on third parties toperform release tests on our product candidates prior to delivery to patients. If these tests are not appropriately done and test dataare not reliable, patients could be put at risk of serious harm.

We maintain single supply relationships for certain key components,and our business and operating results could be harmed if supply is restricted or ends or the price of raw materials used in our suppliers’manufacturing process increases.

We are dependent on sole suppliers or a limitednumber of suppliers for certain components that are integral to our product candidates, including CER-1236. If these or other suppliersencounter financial, operating or other difficulties or if our relationship with them changes, we may be unable to quickly establish orqualify replacement sources of supply and could face production interruptions, delays and inefficiencies. In addition, technology changesby our vendors could disrupt access to required manufacturing capacity or require expensive, time-consuming development efforts to adaptand integrate new equipment or processes. Our growth may exceed the capacity of one or more of these suppliers to produce the needed equipmentand materials in sufficient quantities to support our growth. Any one of these factors could harm our business and growth prospects.

Our product candidates rely on the availability of specialtyraw materials, which may not be available to us on acceptable terms or at all.

Our product candidates, including CER-1236, requiremany specialty raw materials, some of which are manufactured by small companies with limited resources and experience to support a commercialproduct. In addition, those suppliers normally support blood-based hospital businesses and generally do not have the capacity to supportcommercial products manufactured under cGMP by biopharmaceutical firms. The suppliers may be ill-equipped to support our needs, especiallyin non-routine circumstances like an FDA inspection or medical crisis, such as widespread contamination. We also do not have contractswith many of these suppliers and may not be able to contract with them on acceptable terms or at all. Accordingly, we may experience delaysin receiving key raw materials to support clinical or commercial manufacturing.

In addition, some of our raw materials are currentlyavailable from a single supplier, or a small number of suppliers. For example, the type of cell culture media and cryopreservation bufferthat we currently use in our manufacturing process for the CER-T cells are available from multiple suppliers, but each version may performdifferently, requiring us to characterize them and modify our protocols if we change suppliers. Disruption of our cell manufacturing processmay affect product health, fitness, and potentially anti-tumor activity and clinical responses. In addition, the cell processing equipmentand tubing that we use in our current manufacturing process is only available from a single supplier. We also use certain biologic materials,including certain activating antibodies, that are available from multiple suppliers, but each version may perform differently, requiringus to characterize them and potentially modify some of our protocols if we change suppliers. We cannot be sure that these suppliers willremain in business, or that they will not be purchased by one of our competitors or another company that is not interested in continuingto produce these materials for our intended purpose. If we are required to change suppliers, the materials may only be available fromanother supplier on terms that are less favorable to us than the terms under which we currently obtain the materials. Accordingly, ifwe no longer have access to these suppliers, we may experience delays in our clinical or commercial manufacturing which could harm ourbusiness or results of operations.

If we or our third-party suppliers use hazardous, non-hazardous,biological or other materials in a manner that causes injury or violates applicable law, we may be liable for damages.

Our R&D activities involve the controlleduse of potentially hazardous substances, including chemical and biological materials. We and our suppliers are subject to federal, stateand local laws and regulations in the United States governing the use, manufacture, storage, handling and disposal of medical andhazardous materials. Although we believe that we and our suppliers’ procedures for using, handling, storing and disposing of thesematerials comply with legally prescribed standards, we and our suppliers cannot completely eliminate the risk of contamination or injuryresulting from medical or hazardous materials. As a result of any such contamination or injury, we may incur liability or local, city,state or federal authorities may curtail the use of these materials and interrupt our business operations. In the event of an accident,we could be held liable for damages or penalized with fines, and the liability could exceed our resources. We do not have any insurancefor liabilities arising from medical or hazardous materials. In addition, any violation in the use, manufacture, storage, handling anddisposal under foreign law may subject us to additional liability.

Compliance with applicable environmental lawsand regulations is expensive, and current or future environmental regulations may impair our research, development and production efforts,which could harm our business, prospects, financial condition or results of operations.

Risks Related to Government and Regulation

Clinical development and the regulatory approval process involvea lengthy and expensive process with an uncertain outcome and results of earlier studies and preclinical data, and trials may not be predictiveof future clinical trial results. If our preclinical studies and clinical trials are not sufficient to support regulatory approval ofany of our product candidates, we may incur additional costs or experience delays in completing, or ultimately be unable to complete,the development of such product candidate.

The research, testing, manufacturing, labeling,licensure, sale, marketing and distribution of biological products are subject to extensive regulation by the FDA and other regulatoryauthorities in the United States and other countries, and such regulations differ from country to country. We are not permitted tomarket our product candidates in the United States or in any foreign countries until they receive the requisite licensure from theapplicable regulatory authorities of such jurisdictions. We have not previously submitted a BLA to the FDA or similar licensure applicationsto comparable foreign regulatory authorities. A BLA must include extensive preclinical and clinical data and supporting information toestablish the product candidate’s safety, purity and potency for each desired indication. The BLA must also include significantinformation regarding the manufacturing controls for the product. We expect the novel nature of our product candidates to create furtherchallenges in obtaining regulatory approval. Accordingly, the regulatory approval pathway for our product candidates may be uncertain,complex, expensive and lengthy, and licensure may not be obtained.

We cannot be certain that our preclinical studiesand clinical trial results will be sufficient to support regulatory approval of our product candidates. Clinical testing is expensiveand can take many years to complete and its outcome is inherently uncertain. Human clinical trials are expensive and difficult todesign and implement, in part because they are subject to rigorous regulatory requirements. Failure or delay can occur at any time duringthe clinical trial process.

We may experience delays in obtaining the FDA’sauthorization to initiate clinical trials under future INDs and completing ongoing clinical studies of our product candidates due to avariety of factors. Additionally, we cannot be certain that preclinical studies or clinical trials for our product candidates will beginon time, not require redesign, enroll an adequate number of subjects on time, or be completed on schedule, if at all. Clinical trialscan be delayed or terminated for a variety of reasons, including delays or failures related to:

We may experience numerous adverse or unforeseenevents during, or as a result of, preclinical studies and clinical trials that could delay or prevent our ability to receive marketingapproval or commercialize our product candidates, including:

If we are required to conduct additional clinicaltrials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to successfully completeclinical trials of our product candidates or other testing, if the results of these trials or tests are not positive or are only moderatelypositive or if there are safety concerns, our business and results of operations may be adversely affected and we may incur significantadditional costs. In addition, costs to treat patients with relapsed or refractory cancer and to treat potential side effects that mayresult from our product candidates can be significant. Accordingly, our clinical trial costs are likely to be significantly higher thanthose for more conventional therapeutic technologies or drug product candidates.

We could also encounter delays if a clinical trialis suspended or terminated by us, by the IRBs of the institutions in which such clinical trials are being conducted, by the Data SafetyMonitoring Board for such clinical trial or by the FDA or other regulatory authorities. Such authorities may suspend or terminate a clinicaltrial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinicaltrial protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in theimposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from the product candidates,changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. For example,in July 2024, we announced a clinical hold as a result of insufficient data provided with regard to two issues within pharmacology andtoxicology of CER-1236. We plan to work expeditiously to resolve this clinical hold so that CER-1236 may proceed to the clinic, but thereis no guarantee that we will be able to address the clinical hold issues to FDA’s satisfaction or in a timely manner to resume development.

Any delay in obtaining, or inability to obtain,applicable regulatory approval would delay or prevent commercialization of our product candidates and would materially adversely impactour business and prospects and our ability to generate revenues from any of these product candidates will be delayed or not realized atall. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimatelylead to the denial of regulatory approval of our product candidates. If one or more of our product candidates generally prove to be ineffective,unsafe or commercially unviable, our CER-T cell platform would have little, if any, value, which would have a material and adverse effecton our business, financial condition, results of operations and prospects.

Any of these factors, many of which are beyondour control, may result in our failing to obtain regulatory approval to market any of our product candidates, or a delay in such approval,which would significantly harm our business, results of operations, and prospects. Of the large number of biological products in development,only a small percentage successfully complete the FDA or other regulatory approval processes and are commercialized. Even if we eventuallycomplete clinical testing and receive licensure from the FDA or applicable foreign regulatory authorities for any of our product candidates,the FDA or the applicable foreign regulatory may license our product candidates for a more limited indication or a narrower patient populationthan we originally requested, and the FDA, or applicable foreign regulatory agency, may not license our product candidates with the labelingthat we believe is necessary or desirable for the successful commercialization of such product candidates.

Our manufacturing process needs to comply with FDA regulationsrelating to the quality and reliability of such processes. Any failure to comply with relevant regulations could result in delays in ortermination of our clinical programs and suspension or withdrawal of any regulatory approvals.

In order to commercially produce our productsat a third party’s facility, we will need to comply with the FDA’s cGMP regulations and guidelines, including cGTPs. We mayencounter difficulties in achieving quality control and quality assurance and may experience shortages in qualified personnel. We aresubject to inspections by the FDA and comparable foreign regulatory authorities to confirm compliance with applicable regulatory requirements.Any failure to follow cGMP, cGTP or other regulatory requirements or delay, interruption or other issues that arise in the manufacture,fill-finish, packaging, or storage of our CER-T cells as a result of a failure of the facilities or operations of third parties to complywith regulatory requirements or pass any regulatory authority inspection could significantly impair our ability to develop and commercializeour CER-T cell programs, including leading to significant delays in the availability of our CER-T cells for our clinical trials or thetermination of or suspension of a clinical trial, or the delay or prevention of a filing or approval of marketing applications for ourCER-T cell product candidates. Significant non-compliance could also result in the imposition of sanctions, including warning or untitledletters, fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approvals for our CER-T cell productcandidates, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products, operating restrictionsand criminal prosecutions, any of which could damage our reputation and our business.

 The FDA has placed a clinical holdon CER-1236. If the FDA does not remove the clinical hold in a timely basis, or at all, our development timelines and our business maybe adversely affected, and our stock price may decline.

As previously announced by the Company in July2024, the FDA placed a full clinical hold on CER-1236 as a result of insufficient data provided with regard to two issues within pharmacologyand toxicology of CER-1236. We plan to work expeditiously to resolve this clinical hold so that CER-1236 may proceed to the clinic, butthere is no guarantee that we will be able to address the clinical hold issues to FDA’s satisfaction or in a timely manner to resumedevelopment. If the FDA does not lift the clinical hold in a timely manner, or at all, our long-term development timeline for CER-1236and our business, financial condition or results of operations, may be adversely affected.

Even if we receive regulatory approval for any of our productcandidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense.Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we maybe subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.

If the FDA, EMA or any other comparable regulatoryauthority approves any of our product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting,storage, advertising, promotion and recordkeeping for the product will be subject to extensive and ongoing regulatory requirements. Theserequirements include submissions of safety and other post-marketing information and reports, registration requirements, applicable producttracking and tracing requirements and continued compliance with cGMPs, including cGTPs, and GCP, for any clinical trials that we conductpost-approval. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency,or with any future potential manufacturing facilities we may own, third-party manufacturers or manufacturing processes, or failure tocomply with regulatory requirements, may result in, among other things:

Moreover, if any of our product candidates areapproved, our product labeling, advertising and promotion will be subject to regulatory requirements and continuing regulatory review.The FDA strictly regulates the promotional claims that may be made about biopharmaceutical products. In particular, a product may notbe promoted for uses that are not approved by the FDA as reflected in the product’s approved labeling.

Any government investigation of alleged violationsof law could require us to expend significant time and resources in response and could generate negative publicity. The occurrence ofany event or penalty described above may inhibit our or our collaborators’ ability to commercialize our product candidates, andharm our business, financial condition and results of operations.

In addition, the policies of the FDA, the EMAand other comparable regulatory authorities may change and additional government regulations may be enacted that could prevent, limitor delay regulatory approval of our product candidates. If we are slow or unable to adapt to changes in existing requirements or the adoptionof new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we mayhave obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.

We also cannot predict the likelihood, natureor extent of government regulation that may arise from future legislation or administrative or executive action, either in the United Statesor abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements, or if we are unableto maintain regulatory compliance, marketing approval that has been obtained may be lost and we may not achieve or sustain profitability.

Regulatory requirements in the United States and abroadgoverning cell therapy products have changed frequently and may continue to change in the future, which could negatively impact our abilityto complete clinical trials and commercialize our product candidates in a timely manner, if at all.

Regulatory requirements in the United Statesand abroad governing cell therapy products have changed frequently and may continue to change in the future. In 2016, the FDA establishedthe Office of Tissues and Advanced Therapies (“OTAT”) within its Center for Biologics Evaluation and Research to consolidatethe review of gene therapy and related products, and has established the Cellular, Tissue and Gene Therapies Advisory Committee, amongothers, to advise this review. In September 2022, the FDA announced retitling of OTAT to the Office of Therapeutic Products (“OTP”)and elevation of OTP to a “Super Office” to meet its growing cell and gene therapy workload. In addition, under guidelinesissued by the National Institute of Health (the “NIH”), gene therapy clinical trials are also subject to review and oversightby an institutional biosafety committee (“IBC”), a local institutional committee that reviews and oversees research utilizingrecombinant or synthetic nucleic acid molecules at that institution. Before a clinical trial can begin at any institution, that institution’sinstitutional review board, or IRB, and its IBC assesses the safety of the research and identifies any potential risk to public healthor the environment. While the NIH guidelines are not mandatory unless the research in question is being conducted at or sponsored by institutionsreceiving NIH funding of recombinant or synthetic nucleic acid molecule research, many companies and other institutions not otherwisesubject to the NIH guidelines voluntarily follow them. Moreover, serious adverse events or developments in clinical trials of gene therapyproduct candidates conducted by others may cause the FDA or other regulatory bodies to initiate a clinical hold on our clinical trialsor otherwise change the requirements for approval of any of our product candidates. Although the FDA decides whether individual cell andgene therapy protocols may proceed, the review process and determinations of other reviewing bodies can impede or delay the initiationof a clinical trial, even if the FDA has reviewed the trial and approved its initiation.

We may seek fast track and breakthrough therapy designationsor priority review for one or more of our product candidates, but we might not receive such designation or priority review, and even ifwe do, such designation or priority review may not lead to a faster development or regulatory review or approval process, and does notassure FDA approval of our product candidates. Even if a product qualifies for such designation or priority review, the FDA may laterdecide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval willnot be shortened.

We may seek fast track, breakthrough therapy,and/or regenerative medicine advanced therapy designations or priority review for one or more of our product candidates.

The FDA may issue a fast track designation toa product candidate if it is intended, whether alone or in combination with one or more other products, for the treatment of a seriousor life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition.Fast track designation applies to the combination of the product and the specific indication for which it is being studied. The sponsorof a new biologic may request that the FDA designate the biologic as a fast track product at any time during the clinical developmentof the product. For fast track products, sponsors may have greater interactions with the FDA during product development. A fast trackproduct may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basis before thecomplete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDA agrees toaccept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submissionof the first section of the BLA. However, the FDA’s goal for reviewing a BLA fast track application under the PDUFA does notbegin until the last section of the application is submitted. Fast track designation may be withdrawn by the FDA if the FDA believes thatthe designation is no longer supported by data emerging in the clinical trial process.

A breakthrough therapy is defined as a productcandidate that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition,and preliminary clinical evidence indicates that the product candidate may demonstrate substantial improvement over existing therapieson one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For productcandidates that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trialcan help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective controlregimens. Product candidates designated as breakthrough therapies by the FDA are also eligible for priority review if supported by clinicaldata at the time of the submission of the BLA.

Fast track designation, priority review, and breakthroughtherapy designation are within the discretion of the FDA. Accordingly, even if we believe that one of our product candidates meetsthe criteria for any such designation, the FDA may disagree and instead determine not to make such designation. In any event, the receiptof such designation may expedite the development or approval process, but do not change the standards for approval. Even if a productqualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditions for qualificationor decide that the time period for FDA review or approval will not be shortened.

We may seek approval of our product candidates, where applicable,under the FDA’s accelerated approval pathway. This pathway may not lead to a faster development, regulatory review or approval processand does not increase the likelihood that our product candidates will receive marketing approval.

A product may be eligible for accelerated approvalif it is designed to treat a serious or life-threatening disease or condition and generally provides a meaningful advantage over availabletherapies upon a determination that the product candidate has an effect on a surrogate endpoint or intermediate clinical endpoint thatis reasonably likely to predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversible morbidity ormortality, (“IMM”) that is reasonably likely to predict an effect on IMM or other clinical benefit. The FDA considers a clinicalbenefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as IMM. For thepurposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical signor other measure that is thought to predict clinical benefit, but is not itself a measure of clinical benefit. An intermediate clinicalendpoint is a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality that is reasonablylikely to predict an effect on irreversible morbidity or mortality or other clinical benefit. The accelerated approval pathway may beused in cases in which the advantage of a new drug over available therapy may not be a direct therapeutic advantage, but is a clinicallyimportant improvement from a patient and public health perspective. If granted, accelerated approval is usually contingent on the sponsor’sagreement to conduct, in a diligent manner, additional post-approval confirmatory studies to verity and describe the drug’s clinicalbenefit. Under the FDORA, the FDA is permitted to require, as appropriate, that a post-approval confirmatory study or studies be underwayprior to approval or within a specified time period after the date of accelerated approval was granted. FDORA also requires sponsors tosend updates to the FDA every 180 days on the status of such studies, including progress toward enrollment targets, and the FDA mustpromptly post this information publicly. FDORA also gives the FDA increased authority to withdraw approval of a drug or biologic grantedaccelerated approval on an expedited basis if the sponsor fails to conduct such studies in a timely manner, send the necessary updatesto the FDA, or if such post-approval studies fail to verify the drug’s predicted clinical benefit. Under FDORA, the FDA is empoweredto take action, such as issuing fines, against companies that fail to conduct with due diligence any post-approval confirmatory studyor submit timely reports to the agency on their progress. In addition, the FDA currently requires, unless otherwise informed by the agency,pre-approval of promotional materials for products receiving accelerated approval, which could adversely impact the timing of the commerciallaunch of the product. Thus, even if we seek to utilize the accelerated approval pathway, we may not be able to obtain accelerated approvaland, even if we do, we may not experience a faster development, regulatory review or approval process for that product. There can be noassurance that the FDA would allow any of the product candidates we may develop to proceed on an accelerated approval pathway, and evenif the FDA did allow such pathway, there can be no assurance that such submission or application will be accepted or that any expediteddevelopment, review or approval will be granted on a timely basis, or at all. Moreover, even if we received accelerated approval, anypost-approval studies required to confirm and verify clinical benefit may not show such benefit, which could lead to withdrawal of anyapprovals we have obtained. Receiving accelerated approval does not assure that the product’s accelerated approval will eventuallybe converted to a traditional approval.

We may not be able to obtain orphan drug exclusivity for oneor more of our product candidates, and even if we do, that exclusivity may not prevent the FDA from approving other competing products.

Regulatory authorities may designate drugs forrelatively small patient populations as “orphan” drugs. Generally, if a product with an orphan drug designation subsequentlyreceives the first marketing approval for the indication for which it has such designation, the product is entitled to a period of marketexclusivity, which, subject to certain exceptions, precludes the FDA from approving another marketing application for the same drug forthe same indication for that time period. The applicable market exclusivity period is seven years in the United States.

Obtaining orphan drug exclusivity for our productcandidates may be important to our commercial strategy. If a competitor obtains orphan drug exclusivity for and approval of a productwith the same indication as our product candidates before we do, and if the competitor’s product is the same drug or a similar medicinalproduct as ours, we could be excluded from the market. Even if we obtain orphan drug exclusivity after FDA approval, we may not be ableto maintain it. For example, if a competitive product that is the same drug or a similar medicinal product as our product candidate isshown to be clinically superior to our product candidate, any orphan drug exclusivity we have obtained will not block the approval ofsuch competitive product. In addition, orphan drug exclusivity will not prevent the approval of a product that is the same drug as ourproduct candidates if the FDA finds that we cannot assure the availability of sufficient quantities of the drug to meet the needs of thepersons with the disease or condition for which the drug was designated. If one or more of these events occur, it could have a materialadverse effect on our company.

We are subject to stringent and changing privacy laws, regulationsand standards as well as policies, contracts and other obligations related to data privacy and security. Our actual or perceived failureto comply with such obligations could lead to enforcement or litigation (that could result in fines or penalties), a disruption of clinicaltrials or commercialization of products, reputational harm, or other adverse business effects.

In the ordinary course of business, we will collect,receive, store, process, use, generate, transfer, disclose, make accessible, protect, secure, dispose of, transmit and share (collectively,processing) personal data and other sensitive information, including, but not limited to, proprietary and confidential business information,trade secrets, intellectual property, and information we collect about patients in connection with clinical trials. Accordingly, we are,or may become, subject to numerous federal, state, local and international data privacy and data security laws, regulations, guidance,and industry standards as well as external and internal privacy and data security policies, contracts and other obligations that applyto our processing of personal data and the processing of personal data on our behalf.

In the United States, federal, state, andlocal governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacylaws, consumer protection laws and other similar laws (e.g., unfair or deceptive acts or practices pursuant to Section 5(a) ofthe Federal Trade Commission Act). For example, HIPAA, as amended by the Health Information Technology for Economic and Clinical HealthAct (“HITECH”), and their respective implementing regulations, imposes requirements relating to the privacy, security andtransmission of protected health information. Among other things, HITECH, through its implementing regulations, makes certain of HIPAA’sprivacy and security standards directly applicable to business associates, defined as a person or organization, other than a member ofa covered entity’s workforce, that creates, receives, maintains or transmits protected health information for or on behalf of acovered entity for a function or activity regulated by HIPAA as well as their covered subcontractors.

In addition, the California Consumer Privacy Act(“CCPA”) applies to personal information of consumers, business representatives, and employees, and creates individual privacyrights and places increased privacy and security obligations on entities handling personal data of consumers or households. The CCPA requirescovered companies to provide disclosures to California consumers, affords California residents certain rights related to their personaldata, including the right to opt-out of certain sales of personal data, and allow for a new cause of action for certain data breaches.Although there are limited exemptions for clinical trial data under the CCPA, as our business progresses, the CCPA may become applicableand significantly impact our business activities and exemplifies the vulnerability of our business to evolving regulatory environmentrelated to personal data and protected health information. Furthermore, the California Privacy Rights Act of 2020, effectiveJanuary 1, 2023, expands the CCPA’s requirements, including by applying to personal information of business representativesand employees and establishing a new regulatory agency to implement and enforce the law. In addition, other states, such as Virginia andColorado, have also passed comprehensive privacy laws, and similar laws are being considered in several other states, as well as at thefederal and local levels. While these states, like the CCPA, also exempt some data processed in the context of clinical trials, thesedevelopments further complicate compliance efforts, and increase legal risk and compliance costs for us and the third parties upon whomwe rely. Moreover, data privacy and security laws have been proposed at the federal, state, and local levels in recent years, whichcould further complicate compliance efforts.

Outside the United States, there are an increasingnumber of laws, regulations and industry standards concerning privacy, data protection, information security and cross-border personaldata transfers. For example, GDPR, UK GDPR, and China’s Personal Information Protection Law impose strict requirements for processingpersonal data. Failure to comply with the requirements of the GDPR and the applicable national data protection laws of the European UnionMember States may result in fines of up to €20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financialyear, whichever is higher, other administrative penalties, and private litigation related to processing of personal data brought by classesof data subjects or consumer protection organizations authorized at law to represent their interests. If we cannot implement a valid compliancemechanism for cross-border data transfers, we may face increased exposure to regulatory actions, substantial fines, and injunctions againstprocessing or transferring personal data from Europe or other foreign jurisdictions. The inability to import personal data to the United Statescould significantly and negatively impact our business operations, including by limiting our ability to conduct clinical trial activitiesin Europe and elsewhere; limiting our ability to collaborate with parties that are subject to such cross-border data transfer or localizationlaws; or requiring us to increase our personal data processing capabilities and infrastructure in foreign jurisdictions at significantexpenses. European regulators have also ordered certain companies to suspend or permanently cease certain transfers out of Europe forallegedly violating the GDPR’s cross-border data transfer limitations.

In addition, privacy advocates and industry groupshave proposed, and may propose, standards with which we are legally or contractually bound to comply. We are also bound by contractualobligations related to data privacy and security, and our efforts to comply with such obligations may not be successful. If any of ourprivacy policies or related materials or statements are found to be deficient, lacking in transparency, deceptive, unfair, or misrepresentativeof our practices, we may be subject to investigation, enforcement actions by regulators or other adverse consequences.

Our obligations related to data privacy and securityare quickly changing in an increasingly stringent fashion, creating some uncertainty as to the effective future legal framework. Additionally,these obligations may be subject to differing applications and interpretations, which may be inconsistent or conflict among jurisdictions.As a result, preparing for and complying with these obligations requires significant resources and may necessitate changes to our informationtechnologies, systems and practices, as well as those of any third-party collaborators, service providers, contractors, consultants orother third parties that process personal data on our behalf.

Although we endeavor to comply with all applicableprivacy and security obligations, we may at times fail to do so or may be perceived to have failed to do so. Moreover, despite our efforts,we may not be successful in achieving compliance if our employees, third-party collaborators, service providers, contractors or consultantsfail to comply with such obligations, which could negatively impact our business operations and compliance posture. For example, any failureby a third-party service provider to comply with applicable law, regulations, or contractual obligations could result in adverse effects,including inability to or interruption in our ability to operate our business and proceedings against us by governmental entities or others.If we fail, or are perceived to have failed, to address or comply with obligations related to data privacy and security obligations, wecould face significant consequences. These consequences may include, but are not limited to, government enforcement actions (e.g., investigations,fines, penalties, audits and inspections, and similar); litigation (including class-related claims); additional reporting requirementsand/or oversight; temporary or permanent bans on all or some processing of personal data; orders to destroy or not use personal data;and imprisonment of company officials. Any of these events could have a material adverse effect on our reputation, business, or financialcondition.

The impact of recent healthcare reform legislation and otherchanges in the healthcare industry and in healthcare spending on us is currently unknown, and may adversely affect our business model.

Our revenue prospects could be affected by changesin healthcare spending and policy in the United States and abroad. We operate in a highly regulated industry and new laws, regulationsor judicial decisions, or new interpretations of existing laws, regulations or decisions, related to healthcare availability, the methodof delivery or payment for healthcare products and services could negatively impact our business, operations and financial condition.

There have been, and likely will continue to be,legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare andcontaining or lowering the cost of healthcare. For more information, see the section of this report titled “Business –Healthcare Laws and Regulations – Healthcare Reform.”

The continuing efforts of the government, insurancecompanies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose pricecontrols may adversely affect:

Any reduction in reimbursement from Medicare orother government programs may result in a similar reduction in payments from private payors, which may adversely affect our future profitability.

Our business could be negatively impacted by environmental, socialand corporate governance matters or our reporting of such matters.

Investors have increased their emphasis on theenvironmental, social and governance (“ESG”) practices of companies across all industries, including the environmental impactof operations and human capital management. Expectations regarding voluntary ESG initiatives and disclosures may result in increased costs(including but not limited to increased costs related to compliance, stakeholder engagement, contracting and insurance), enhanced complianceor disclosure obligations, or other adverse impacts to our business, financial condition, or results of operations.

While we have internal efforts directed at ESGmatters and preparations for any increased required future disclosures, such initiatives may be costly and may not have the desired effect.We may be perceived to be not acting responsibly in connection with these matters, which could negatively impact us. Moreover, we maynot be able to successfully complete such initiatives due to factors that are within or outside of our control. Even if this is not thecase, our actions may subsequently be determined to be insufficient by various stakeholders, and we may be subject to investor or regulatorengagement on our ESG efforts, even if such initiatives are currently voluntary.

Certain market participants, including major institutionalinvestors and capital providers, use third-party benchmarks and scores to assess companies’ ESG profiles in making investment orvoting decisions. A failure to comply with investor expectations and standards, which are evolving and vary considerably, or the perceptionthat we have not responded appropriately to the growing concern for ESG issues, could result in reputational harm to our business andcould have an adverse effect on us. To the extent ESG matters negatively impact our reputation, it may also negatively impact our shareprice as well as our access to and cost of capital and impede our ability to compete as effectively to attract and retain employees, whichmay adversely impact our operations.

Our ability to utilize our net operating loss carryforwards andcertain other tax attributes may be limited.

Under current law, federal net operating lossesincurred in tax years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibility of suchfederal net operating losses is limited to 80% of taxable income. It is uncertain if and to what extent various states will conform tofederal tax laws. Under Sections 382 and 383 of the Code, and corresponding provisions of state law, if a corporation undergoes an “ownershipchange” (generally defined as a greater than 50 percentage point change (by value) in the equity ownership of certain stockholdersover a rolling three-year period), the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-changetax attributes to offset its post-change income or taxes may be limited. We have not yet completed a Section 382 or Section 383analysis, and therefore, there can be no assurances that any previously experienced ownership changes have not materially limited ourutilization of affected net operating loss carryforwards or other tax attributes. We may experience ownership changes in the future, includingin connection with the proposed Business Combination as a result of shifts in our stock ownership. We anticipate incurring significantadditional net losses for the foreseeable future, and our ability to utilize net operating loss carryforwards associated with any suchlosses to offset future taxable income may be limited to the extent we incur future ownership changes. In addition, at the state level,there may be periods during which the use of net operating loss carryforwards is suspended or otherwise limited, which could accelerateor permanently increase state taxes owed. As a result, we may be unable to use all or a material portion of our net operating loss carryforwardsand other tax attributes, which could adversely affect our future cash flows.

Changes in tax laws or regulations that are applied adverselyto us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations.

New income, sales, use or other tax laws, statutes,rules, regulations or ordinances could be enacted at any time, which could adversely affect our business operations and financial performance.Further, existing tax laws, statutes, rules, regulations or ordinances could be interpreted, changed, modified or applied adversely tous. For example, the Biden administration and Congress have proposed various U.S. federal tax law changes, which if enacted couldhave a material impact on our business, cash flows, financial condition or results of operations. In addition, it is uncertain if andto what extent various states will conform to federal tax laws. Future tax reform legislation could have a material impact on the valueof our deferred tax assets, could result in significant one-time charges, and could increase our future U.S. tax expense.

Even if we obtain FDA approval of any of our product candidates,we may never obtain approval or commercialize such products outside of the United States, which would limit our ability to realizetheir full market potential.

In order to market any products outside of theUnited States, we must establish and comply with numerous and varying regulatory requirements of other countries regarding safetyand efficacy. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatoryapproval in one country does not mean that regulatory approval will be obtained in any other country. Approval procedures vary among countriesand can involve additional product testing and validation and additional administrative review periods.

Seeking foreign regulatory approvals could resultin significant delays, difficulties and costs for us and may require additional preclinical studies or clinical trials which would becostly and time consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introductionof our products in those countries. Satisfying these and other regulatory requirements is costly, time consuming, uncertain and subjectto unanticipated delays. In addition, our failure to obtain regulatory approval in any country may delay or have negative effects on theprocess for regulatory approval in other countries. We do not have any product candidates approved for sale in any jurisdiction, includinginternational markets, and we do not have experience in obtaining regulatory approval in international markets. If we fail to comply withregulatory requirements in international markets or to obtain and maintain required approvals, our ability to realize the full marketpotential of our products will be harmed.

Our business operations and current and future relationshipswith healthcare professionals, principal investigators, consultants, customers and third-party payors in the United States and elsewheremay be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency, healthinformation privacy and security and other healthcare laws and regulations, which could expose us to substantial penalties.

Healthcare providers, physicians and third-partypayors in the United States and elsewhere will play a primary role in the recommendation and prescription of any product candidatesfor which we obtain marketing approval. Our current and future arrangements with healthcare professionals, principal investigators, consultants,customers and third-party payors may expose us to broadly applicable fraud and abuse and other healthcare laws, including, without limitation,the U.S. federal Anti-Kickback Statute and the U.S. federal False Claims Act, that may constrain the business or financial arrangementsand relationships through which we sell, market and distribute any product candidates for which we obtain marketing approval. In addition,we may be subject to physician payment transparency laws and patient privacy and security regulation by the U.S. federal governmentand by the states and foreign jurisdictions in which we conduct our business. For more information, see the section of this report titled“Business – Healthcare Laws and Regulations.”

Because of the breadth of these laws and the narrownessof their exceptions and safe harbors, it is possible that our business activities can be subject to challenge under one or more of suchlaws. The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcarereform. Federal and state enforcement bodies have continued their scrutiny of interactions between healthcare companies and healthcareproviders, which has led to a number of significant investigations, prosecutions, convictions and settlements in the healthcare industry.

Efforts to ensure that our internal operationsand future business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantialcosts. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us,we may be subject to significant civil, criminal and administrative penalties, including, without limitation, damages, monetary fines,imprisonment, disgorgement of profits, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs,contractual damages, reputational harm, diminished profits and future earnings, additional reporting or oversight obligations if we becomesubject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law and curtailment orrestructuring of our operations, any of which could adversely affect our ability to operate our business and pursue our strategy. If anyof the physicians or other healthcare providers or entities with whom we expect to do business, including future collaborators, are foundnot to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusionsfrom participation in government healthcare programs, which could also affect our business.

If we fail to comply with environmental, health and safety lawsand regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the successof our business.

We are subject to numerous environmental, healthand safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposalof hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and biologicaland radioactive materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposalof these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contaminationor injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceedour resources. We also could incur significant costs associated with civil or criminal fines and penalties.

Although we maintain workers’ compensationinsurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials,this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liabilityor toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactivematerials.

We may be affected by regulatory responses to climate-relatedissues.

The Biden administration has made climate changeand the limitation of greenhouse gas (“GHG”) emissions one of its primary objectives. Several states and other geographicregions in the United States have also adopted legislation and regulations to reduce emissions of GHGs.

On March 6, 2024, the SEC finalized new rulesfor public companies that will require extensive climate-related disclosures and significant analysis of the impact of climate-relatedissues on our business strategy, results of operations, and financial condition (the “SEC Climate Disclosure Rules”). Thenew rules will require us to disclose our material climate-related risks and opportunities, GHG emissions inventory, climate-related targetsand goals, and financial impacts of physical and transition risks. As a result of the SEC Climate Disclosure Rules, our legal, accounting,and other compliance expenses may increase significantly, and compliance efforts may divert management time and attention. We may alsobe exposed to legal or regulatory action or claims as a result of these new regulations. All of these risks could have a material adverseeffect on our business, financial position, and/or stock price.

Risks Related to Intellectual Property

Our intellectual property rights are valuable, and any inabilityto protect them could reduce the value of our products, services and brand.

The loss of any procured intellectual propertyrights in our products could permit our competitors to manufacture their own version of our products. We have attempted to protect ourintellectual property rights in our products through a combination of patents, confidentiality agreements, non-compete agreements andother contractual protection mechanisms, and we will continue to do so. While we intend to defend against threats to our intellectualproperty, our patents or various contractual protections may not adequately protect our intellectual property. In addition, we could berequired to expend significant resources to defend our rights to proprietary information, and may not be successful in such defense.

As such, we may not be successful in preventingthird parties from infringing, copying or misappropriating our intellectual property. There can also be no assurance that pending patentapplications owned by us will result in patents being issued to us, that patents issued to or licensed by us in the past or in the futurewill not be challenged or circumvented by competitors or that such patents will be found to be valid or sufficiently broad to protectour products or to provide us with any competitive advantage. Third parties could also obtain patents that may require us to negotiateto obtain licenses to conduct our business, and any required licenses may not be available on reasonable terms or at all. We also relyon confidentiality and non-compete agreements with certain employees, independent distributors, consultants and other parties to protect,in part, trade secrets and other proprietary rights. There can be no assurance that these agreements will not be breached, that we willhave adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary information orthat third parties will not otherwise gain access to our trade secrets or proprietary knowledge.

It is difficult and costly to protect our proprietary rights,and we may not be able to ensure their protection. We cannot assure investors that any of the currently pending or future patent applicationswill result in granted patents, nor can we predict how long it will take for such patents to be granted.

Our commercial success will depend in part onus obtaining and maintaining patent protection and trade secret protection of our current and future product candidates, as well as successfullydefending these patents against third-party challenges. Our ability to stop third parties from making, using, selling, offering to sellor importing our product candidates is dependent upon the extent to which we have rights under valid and enforceable patents or tradesecrets that cover these activities and the right under our licensed patents to contest alleged infringement.

The patent positions of biotechnology and pharmaceuticalcompanies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved.No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to date in the United States orin many jurisdictions outside of the United States. Changes in either the patent laws or interpretations of patent laws in the United Statesand other countries may diminish the value of our owned or licensed intellectual property. Accordingly, we cannot predict the breadthof claims that may be enforced in the patents that may be issued from the applications we currently or may in the future own or licensefrom third parties. Further, if any patents we obtain or license are deemed invalid or unenforceable, our ability to commercialize orlicense our technology could be adversely affected.

Others have filed, and in the future are likelyto file, patent applications covering products and technologies that are similar, identical or competitive to ours or important to ourbusiness. We cannot be certain that any patent application owned by a third party will not have priority over patent applications filedor in-licensed by us, or that we will not be involved in interference, opposition or invalidity proceedings before U.S. or non-U.S. patentoffices.

The degree of future protection for our proprietaryrights is uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gainor keep our competitive advantage. For example:

Should any of these events occur, they could significantlyharm our business, results of operations and prospects.

Without patent protection on the composition ofmatter of our product candidates, our ability to assert our patents to stop others from using or selling our product candidates in a non-pharmaceuticallyacceptable formulation may be limited.

Due to the patent laws of a country, or the decisionsof a patent examiner in a country, or our own filing strategies, we may not obtain patent coverage for all of our product candidates ormethods involving these candidates in parent patent applications. We may have to pursue divisional patent applications or continuationpatent applications in the United States and other countries to obtain claim coverage for inventions which were disclosed but notclaimed in parent patent applications.

Moreover, it is possible that our pending patentapplications will not result in granted patents, and even if such pending patent applications are granted as patents, they may not providea basis for intellectual property protection of commercially viable products nor provide us with any competitive advantages. Further,it is possible that, for any of the patents that may be granted in the future, others will design around the patent rights or identifycancer treatment methods that do not concern the rights covered by our patent rights or licenses. Further, we cannot assure investorsthat other parties will not challenge any patents granted to us or that courts or regulatory agencies will hold our patents to be validor enforceable. We also cannot guarantee that we will be successful in defending challenges made against our patents. Any successful third-partychallenge to our patents could result in the unenforceability or invalidity of such patents, or to such patents being interpreted narrowlyor otherwise in a manner adverse to our interests. Our ability to establish or maintain a technological or competitive advantage overour competitors may be diminished because of these uncertainties.

We may also rely on trade secrets to protect ourtechnology, especially where we do not believe patent protection is appropriate or feasible. However, trade secrets are difficult to protect.Although we use reasonable efforts to protect our trade secrets, our employees, consultants, contractors, outside scientific collaboratorsand other advisors may unintentionally or willfully disclose our information to competitors or other third parties. Enforcing a claimthat a third party illegally obtained and is using any of our trade secrets may be expensive and time consuming, and the outcome is unpredictable.In addition, courts outside the United States are sometimes less willing to protect trade secrets. Moreover, our competitors mayindependently develop equivalent knowledge, methods and know-how.

If we are unable to obtain and maintain patent protection forany products we develop and for our technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitorscould develop and commercialize products and technology similar or identical to ours, and our ability to commercialize any product candidateswe may develop and our technology may be adversely affected.

Our success depends in large part on our abilityto obtain and maintain patent protection in the United States and other countries with respect to our product candidates, their respectivecomponents, formulations, combination therapies, methods used to manufacture them and methods of treatment and development that are importantto our business. If we do not adequately protect our intellectual property rights, competitors may be able to erode or negate any competitiveadvantage we may have, which could harm our business and ability to achieve profitability. To protect our proprietary position, we filepatent applications in the United States and abroad related to our product candidates that are important to our business; we mayin the future also license or purchase patent applications filed by others. If we are unable to secure or maintain patent protection withrespect to our technology and any proprietary products and technology we develop, our business, financial condition, results of operationsand prospects could be materially harmed.

We cannot provide any assurances that any of ourcurrent or future patents have or will include claims with a scope sufficient to protect our current and future product candidates orotherwise provide any competitive advantage. In addition, the laws of foreign countries may not protect our rights to the same extentas the laws of the United States. Furthermore, patents have a limited lifespan. In the United States, the natural expirationof a patent is generally 20 years after its earliest U.S. non-provisional filing date. Various extensions may be available;however, the life of a patent, and the protection it affords, is limited. Given the amount of time required for the development, testingand regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidatesare commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializingproducts similar or identical to ours. Moreover, some of our patents and patent applications are, and may in the future be, owned by orco-owned with third parties. Any of the foregoing could have a material adverse effect on our competitive position, business, financialconditions, results of operations and prospects.

The patent prosecution process is complex, expensive,time-consuming and inconsistent across jurisdictions. We may not be able to file, prosecute, maintain, enforce, or license all necessaryor desirable patent rights at a commercially reasonable cost or in a timely manner. In addition, we may not pursue or obtain patent protectionin all relevant markets. It is possible that we will fail to identify important patentable aspects of our R&D efforts in time to obtainany patent protection. While we enter into non-disclosure and confidentiality agreements with parties who have access to confidentialor patentable aspects of our R&D efforts, including for example, our employees, former employees, corporate collaborators, externalacademic scientific collaborators, CROs, contract manufacturers, consultants, advisors and other third parties, any of these parties maybreach the agreements and disclose such output before a patent application is filed, thereby endangering our ability to seek patent protection.In addition, publications of discoveries in the scientific and scholarly literature often lag behind the actual discoveries, and patentapplications in the United States and other jurisdictions are typically not published until 18 months after filing, or in somecases not at all. Consequently, we cannot be certain that we were the first to file for patent protection on the inventions claimed inour patents or pending patent applications.

The issuance or grant of a patent is not irrefutableas to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United Statesand abroad. There may be prior art of which we are not aware that may affect the validity or enforceability of a patent claim. There alsomay be prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim, which may, nonetheless,ultimately be found to affect the validity or enforceability of a claim. We may in the future, become subject to a third-party pre-issuancesubmission of prior art or opposition, derivation, revocation, re-examination, post-grant or inter partes review, or interferenceproceedings or other similar proceedings challenging our patent rights or the patent rights of others in the USPTO or other foreign patentoffice. An unfavorable determination in any such submission, proceeding or litigation could reduce the scope of or invalidate our patentrights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or extinguishour ability to manufacture or commercialize products without infringing third-party patent rights.

Third-party claims of intellectual property infringement mayprevent or delay our product discovery and development efforts, and could increase our costs.

Our commercial success depends in part on ouravoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigation involving patentsand other intellectual property rights in the biotechnology and pharmaceutical industries, as well as administrative proceedings for challengingpatents, including interference, reexamination, and post grant review proceedings before the USPTO or oppositions and other comparableproceedings in foreign jurisdictions. We may be exposed to, or threatened with, future litigation by third parties having patent or otherintellectual property rights alleging that our product candidates and/or proprietary technologies infringe their intellectual propertyrights. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in thefields in which we are developing our product candidates. As the biotechnology and pharmaceutical industries expand and more patents areissued, the risk increases that our product candidates may give rise to claims of infringement of the patent rights of others. Moreover,it is not always clear to industry participants, including us, which patents cover various types of drugs, products or their methods ofuse or manufacture. Thus, because of the large number of patents issued and patent applications filed in our fields, there may be a riskthat third parties allege they have patent rights encompassing our product candidates, technologies or methods.

Third parties may assert that we are employingtheir proprietary technology without authorization. Generally, conducting preclinical and clinical trials and other development activitiesin the United States is not considered an act of infringement. If CER-1236 or another product candidate is cleared/approved by theFDA, a third party may then seek to enforce its patent by filing a patent infringement lawsuit against us. While we do not believe thatany patent claims that could have a materially adverse effect on the commercialization of our product candidates are valid and enforceable,we may be incorrect in this belief, or we may not be able to prove it in litigation. In this regard, patents issued in the United Statesby law enjoy a presumption of validity that can be rebutted only with evidence that is “clear and convincing,” a heightenedstandard of proof. There may be issued third-party patents of which we are currently unaware with claims to compositions, formulations,methods of manufacture or methods for treatment related to the use or manufacture of our product candidates. Patent applications can takemany years to issue. There may be currently pending patent applications which may later result in issued patents that our productcandidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringesupon these patents. Moreover, we may fail to identify relevant patents or incorrectly conclude that a patent is invalid, not enforceable,exhausted, or not infringed by our activities. If any third-party patents were held by a court of competent jurisdiction to cover themanufacturing process of our product candidates, constructs or molecules used in or formed during the manufacturing process, or any finalproduct itself, the holders of any such patents may be able to block our ability to commercialize the product candidate unless we wereto obtain a license under the applicable patents, or until such patents expire or they are finally determined to be held invalid or unenforceable.Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of our formulations, processes formanufacture or methods of use, the holders of any such patent may be able to block our ability to develop and commercialize the productcandidate unless we were to obtain a license or until such patent expires or is finally determined to be held invalid or unenforceable.In either case, such a license may not be available on commercially reasonable terms or at all. If we are unable to obtain a necessarylicense to a third-party patent on commercially reasonable terms, or at all, our ability to commercialize our product candidates may beimpaired or delayed, which could in turn significantly harm our business. Even if we obtain a license, it may be non-exclusive, therebygiving our competitors access to the same technologies licensed to us. In addition, if the breadth or strength of protection providedby our patents is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or futureproduct candidates.

Parties making claims against us may seek andobtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our productcandidates. Defense of these claims, regardless of their merit, could involve substantial litigation expense and would be a substantialdiversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantialdamages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties,pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure. We cannotpredict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore,even in the absence of litigation, we may need or may choose to obtain licenses from third parties to advance our research or allow commercializationof our product candidates. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In thatevent, we would be unable to further develop and commercialize our product candidates, which could harm our business significantly.

We could be found liable for monetary damages,including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent of a third party. A finding ofinfringement could prevent us from commercializing our product candidates or any future product candidates or force us to cease some ofour business operations, which could materially harm our business.

Although we have reviewed certain third-partypatents and patent filings that we believe may be relevant to our therapeutic candidates or products, we have not conducted a freedom-to-operatesearch or analysis for any of our therapeutic candidates or products, and we may not be aware of patents or pending or future patent applicationsthat, if issued, would block us from commercializing our therapeutic candidates or products. Thus, we cannot guarantee that our therapeuticcandidates or products, or our commercialization thereof, do not and will not infringe any third party’s intellectual property.

We may not be successful in obtaining or maintaining necessaryrights to product components and processes for our manufacturing and development pipeline through acquisitions and in-licenses.

Presently, we have rights to certain intellectualproperty, under issued patents that we own, including U.S. Patent No. 11,655,282 and EP Patent No. 3,519,441, which relate to CER-1236,as well as additional patents which relate to certain other product candidates. U.S. Patent Application Number 17/400,082 was allowedand later issued on May 23, 2023 as U.S. Patent Number 11,655,282. This patent provides coverage over our CER-1236 product candidateand includes claims directed to a CER comprising, at least in part, Tim-4, a phosphatidylserine binding domain, its sequence, and variousTim-4 proteins. Because additional product candidates may require the use of proprietary rights held by third parties, the growth of ourbusiness will likely depend in part on our ability to acquire, in-license or use these proprietary rights. In addition, while we havepatent rights directed to certain T cell constructs, we may not be able to obtain intellectual property rights to broader T cell or engineeredT cell constructs.

Our product candidates may also require specificformulations to work effectively and efficiently and these rights may be held by others. Similarly, efficient production or delivery ofour product candidates may also require specific compositions or methods, and the rights to these may be owned by third parties. We maybe unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual property rights fromthird parties that we identify as necessary or important to our business operations. We may fail to obtain any of these licenses at areasonable cost or on reasonable terms, if at all, which would harm our business. We may need to cease use of the compositions or methodscovered by such third-party intellectual property rights, and may need to seek to develop alternative approaches that do not infringeon such intellectual property rights which may entail additional costs and development delays, even if we were able to develop such alternatives,which may not be feasible. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access tothe same technologies licensed to us. In that event, we may be required to expend significant time and resources to develop or licensereplacement technology. Moreover, the specific antibodies that will be used with our product candidates may be covered by the intellectualproperty rights of others.

Additionally, we may collaborate with academicinstitutions to accelerate our preclinical research or development under written agreements with these institutions. In certain cases,these institutions may provide us with an option to negotiate a license to any of the institution’s rights in technology resultingfrom the collaboration. Regardless of such option, we may be unable to negotiate a license within the specified timeframe or under termsthat are acceptable to us. If we are unable to do so, the institution may offer the intellectual property rights to others, potentiallyblocking our ability to pursue our program. If we are unable to successfully obtain rights to required third-party intellectual propertyor to maintain the existing intellectual property rights we have, we may have to abandon development of such program and our businessand financial condition could suffer.

The licensing and acquisition of third-party intellectualproperty rights is a competitive area, and companies which may be more established, or have greater resources than we do, may also bepursuing strategies to license or acquire third-party intellectual property rights that we may consider necessary or attractive in orderto commercialize our product candidates. More established companies may have a competitive advantage over us due to their size, cash resourcesand greater clinical development and commercialization capabilities.

We may be involved in lawsuits to protect or enforce our patentswhich could be expensive, time-consuming and unsuccessful.

Competitors may infringe our patents. To counterinfringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition,in a legal proceeding, a court may decide that one or more of our patents is not valid or is unenforceable or may refuse to stop the otherparty from using the technology at issue on the grounds that our patents do not cover the technology in question. An adverse result inany litigation or defense proceedings could put one or more of our patents at risk of being invalidated, held unenforceable or interpretednarrowly and could put one or more of our pending patent applications at risk of not issuing. Defense of these claims, regardless of theirmerit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In theevent of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, whichmay be impossible or require substantial time and monetary expenditure.

Interference or derivation proceedings provokedby third parties or brought by the USPTO may be necessary to determine the priority or provenance of inventions with respect to our patentsor patent applications or those of our prospective licensors. An unfavorable outcome could result in a loss of our current patent rightsand could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our businesscould be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Litigation or interference or derivationproceedings may result in a decision adverse to our interests and, even if we are successful, may result in substantial costs and distractour management and other employees. We may not be able to prevent, alone or with our licensors, misappropriation of our trade secretsor confidential information, particularly in countries where the laws may not protect those rights as fully as in the United States.

Furthermore, because of the substantial amountof discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information couldbe compromised by disclosure during this type of litigation. In addition, there could be public announcements of the results of hearings,motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it couldhave a substantial adverse effect on the price of our Common Stock.

Obtaining and maintaining our patent protection depends on compliancewith various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patentprotection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance and annuity fees on any issuedpatent are due to be paid to the USPTO and patent agencies outside the United States in several stages over the lifetime of the patent.The USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment andother similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of alate fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonmentor lapse of the patent, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance events thatcould result in abandonment or lapse of a patent include failure to respond to official actions within prescribed time limits, non-paymentof fees and failure to properly legalize and submit formal documents. If we fail to maintain the patents covering our product candidates,our competitors might be able to enter the market, which would harm our business. In addition, to the extent that we have responsibilityfor taking any action related to the prosecution or maintenance of patents or patent application in-licensed from a third party, any failureon our part to maintain the in-licensed rights could jeopardize our rights under the relevant license and may expose us to liability.

We may be subject to claims challenging the inventorship of ourpatents and other intellectual property.

We may in the future be subject to claims thatformer employees, collaborators, or other third parties have an interest in our patents or other intellectual property as an inventoror co-inventor. For example, we may have inventorship disputes arise from conflicting obligations of consultants or others who are involvedin developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship. Ifwe fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, suchas exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on ourbusiness. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distractionto management and other employees.

We may need to license intellectual property from third parties,and such licenses may not be available or may not be available on commercially reasonable terms.

A third party may hold intellectual property rights,including patent rights, that are important or necessary to the development or manufacture of our product candidates. It may be necessaryfor us to use the patented or proprietary technology of third parties to commercialize our product candidates, in which case we wouldbe required to obtain a license from these third parties. Such a license may not be available on commercially reasonable terms, or atall, and we could be forced to accept unfavorable contractual terms. If we are unable to obtain such licenses on commercially reasonableterms, our business could be harmed.

Issued patents covering our product candidates could be foundunpatentable, invalid or unenforceable if challenged in court or the USPTO.

If we initiate legal proceedings against a thirdparty to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our productcandidate, as applicable, is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleginginvalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidity or unenforceabilityof a patent. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outsidethe context of litigation. Such mechanisms include inter partes review, ex parte re-examination and post grant review inthe United States, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings couldresult in revocation or amendment to our patents in such a way that they no longer cover and protect our product candidates. The outcomefollowing legal assertions of unpatentability, invalidity and unenforceability is unpredictable. With respect to the validity question,for example, we cannot be certain that there is no invalidating prior art, of which we, our patent counsel and the patent examiner wereunaware during prosecution. If a defendant were to prevail on a legal assertion of unpatentability, invalidity and/or unenforceability,we would lose at least part, and perhaps all, of the patent protection on our product candidates. Such a loss of patent protection couldhave a material adverse impact on our business.

Changes to patent law in the United States and in foreignjurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.

As is the case with other biopharmaceutical companies,our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceuticalindustry involve both technological and legal complexity, and is therefore costly, time-consuming and inherently uncertain. In addition,the United States continues to adapt to wide-ranging patent reform legislation, including legislation that became effective startingin 2012. Moreover, recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstancesand weakened the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to our ability to obtainpatents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Dependingon decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change inunpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtainin the future. For example, in the case Assoc. for Molecular Pathology v. Myriad Genetics, Inc., the U.S. Supreme Court heldthat certain claims to DNA molecules are not patentable. While we do not believe that any of the patents owned by us will be found invalidbased on this decision, we cannot predict how future decisions by the courts, Congress or the USPTO may impact the value of our patents.Similarly, any adverse changes in the patent laws of other jurisdictions could have a material adverse effect on our business and financialcondition. Changes in the laws and regulations governing patents in other jurisdictions could similarly have an adverse effect on ourability to obtain and effectively enforce our patent rights.

We may not be able to protect our intellectual property rightsthroughout the world.

We may not be able to protect our intellectualproperty rights outside the United States. Filing, prosecuting and defending patents on product candidates in all countries throughoutthe world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States canbe less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectual propertyrights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third partiesfrom practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventionsin other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to developtheir own products and further, may export otherwise infringing products to territories where we have patent protection, but enforcementis not as strong as that in the United States. These products may compete with our products and our patents or other intellectualproperty rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problemsin protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries which we couldexpand to, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and other intellectual propertyprotection, particularly those relating to biopharmaceutical products, which could make it difficult for us to stop the infringement ofour patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rightsin foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, couldput our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing and could provokethird parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded,if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world maybe inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license.

We may be subject to claims that our employees, consultants orindependent contractors have wrongfully used or disclosed confidential information of third parties.

We have received confidential and proprietaryinformation from third parties. In addition, we employ individuals who were previously employed at other biotechnology or pharmaceuticalcompanies. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwiseused or disclosed confidential information of these third parties or our employees’ former employers. Litigation may be necessaryto defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costand be a distraction to our management and employees.

If we are unable to protect the confidentiality of our tradesecrets, our business and competitive position would be harmed.

In addition to seeking patent protection for ourproduct candidates, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintainour competitive position. We seek to protect our trade secrets, in part, by entering into non-disclosure and confidentiality agreementswith parties who have access to them, such as our employees, consultants, advisors and other third parties. We also enter into confidentialityand invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these parties may breachthe agreements and disclose our proprietary information, including our trade secrets. Monitoring unauthorized uses and disclosures ofour intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectual property will beeffective. In addition, we may not be able to obtain adequate remedies for any such breaches. Enforcing a claim that a party illegallydisclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition,some courts inside and outside the United States are less willing or unwilling to protect trade secrets.

Moreover, our competitors may independently developknowledge, methods and know-how equivalent to our trade secrets. Competitors could purchase our products and replicate some or all ofthe competitive advantages we derive from our development efforts for technologies on which we do not have patent protection. If any ofour trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent them, orthose to whom they communicate it, from using that technology or information to compete with us. If any of our trade secrets were to bedisclosed to or independently developed by a competitor, our competitive position would be harmed.

Our reliance on third parties requires us to share our tradesecrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.

Because we will rely on third parties to researchand develop and to manufacture our product candidates, we must share trade secrets with them. We seek to protect our proprietary technologyin part by entering into confidentiality agreements and, if applicable, material transfer agreements, consulting agreements or other similaragreements with our advisors, employees, third-party contractors and consultants prior to beginning research or disclosing proprietaryinformation. These agreements typically limit the rights of the third parties to use and disclose our confidential information, includingour trade secrets. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and otherconfidential information increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated intothe technology of others, or are disclosed or used in violation of these agreements. Given that our proprietary position is based, inpart, on our know-how and trade secrets, a competitor’s independent discovery of our trade secrets or other unauthorized use ordisclosure would impair our competitive position and may have a material adverse effect on our business.

In addition, these agreements typically restrictthe ability of our advisors, employees, third-party contractors and consultants to publish data potentially relating to our trade secrets,although our agreements may contain certain limited publication rights. For example, any academic institution that we may collaboratewith will likely expect to be granted rights to publish data arising out of such collaboration and any joint R&D programs may requireus to share trade secrets under the terms of our R&D or similar agreements. Despite our efforts to protect our trade secrets, ourcompetitors may discover our trade secrets, either through breach of our agreements with third parties, independent development or publicationof information by any of our third-party collaborators. A competitor’s discovery of our trade secrets would impair our competitiveposition and have an adverse impact on our business.

We may not have sufficient patent lifespan to effectively protectour products and business.

All of our patents are in early stages. Patentshave a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after its earliest U.S. non-provisionalfiling date. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protectingsuch candidates might expire before or shortly after the resulting products are commercialized. As a result, our patents may not provideus with sufficient rights to exclude others from commercializing products similar or identical to ours. We expect to seek extensions ofpatent terms for our issued patents, where available. This includes in the United States under the Hatch-Waxman Act, which permitsa patent term extension of up to five years beyond the original expiration date of the patent as compensation for regulatory delays.However, such a patent term extension cannot lengthen the remaining term of a patent beyond a total of 14 years from the product’sapproval date. Only one patent applicable to an approved drug is eligible for the extension and the application for the extension mustbe submitted prior to the expiration of the patent. During the period of patent term extension, the claims of a patent are not enforceablefor their full scope but are instead limited to the scope of the approved product. In addition, the applicable authorities, includingthe FDA in the United States, and any comparable foreign regulatory authorities, may not agree with our assessment of whether suchextensions are available, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. Inaddition, we may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply priorto the expiration of relevant patents or otherwise failing to satisfy applicable requirements. The terms of our patents may also be affectedby the filing of terminal disclaimers during prosecution before the USPTO and foreign authorities recognizing similar disclaimer mechanisms.A patent subject to a terminal disclaimer may have its term limited so that its lifespan does not extend beyond the term of a relatedpatent having a shorter term. If any of the foregoing occurs, any period during which we have the right to exclusively market our productwill be shorter than we would otherwise have expected, and our competitors may obtain approval of and launch products earlier than mightotherwise have been the case.

The life of patent protection is limited, and third parties coulddevelop and commercialize products and technologies similar or identical to ours and compete directly with us after a patent licensedto us expires, which could materially and adversely affect our ability to commercialize our products and technologies.

The life of a patent and the protection it affordsis limited. For example, in the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally20 years from its earliest U.S. non-provisional filing date. In Europe, the expiration of an invention patent is 20 yearsfrom its filing date. Even if we successfully obtain patent protection for an approved product candidate, it may face competition frombiosimilar medications. Manufacturers of other drugs may challenge the scope, validity or enforceability of the patents underlying ourtechnology in court or before a patent office, and the patent holder may not be successful in enforcing or defending those intellectualproperty rights and, as a result, we may not be able to develop or market the relevant product candidate exclusively, which would materiallyadversely affect any potential sales of that product.

Given the amount of time required for the development,testing and regulatory review of new product candidates, patents protecting such product candidates might expire before or shortly aftersuch product candidates are commercialized. As a result, the patents or pending applications licensed to us may not provide us with sufficientrights to exclude others from commercializing products similar or identical to ours. Even if we believe that the patents involved areeligible for certain (and time-limited) patent term extensions, there can be no assurance that the applicable authorities, including theFDA and the USPTO, and any equivalent regulatory authority in other countries, will agree with our assessment of whether such extensionsare available, and such authorities may refuse to grant extensions to such patents, or may grant more limited extensions than requested.Moreover, the applicable time period or the scope of patent protection afforded could be less than requested. If we are unable to obtainpatent term extension or term of any such extension is less than requested, our competitors may obtain approval of competing productsfollowing our patent expiration, and our business could be harmed. Changes in either the patent laws or interpretation of the patent lawsin the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection.

The patent pending applications for our productcandidates are expected to expire on various dates. Upon the expiration, we will not be able to assert such licensed patent rights againstpotential competitors, which would materially adversely affect our business, financial condition, results of operations and prospects.

Risks Related to Ownership of our Securities

An active trading market for our Common Stock may not be availableon a consistent basis to provide stockholders with adequate liquidity. The price of our Common Stock may be extremely volatile, and stockholderscould lose all or part of their investment.

The trading price of our Common Stock is likelyto be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control,including limited trading volume. In addition to the factors discussed in this “Risk Factors” section and elsewherein this prospectus, these factors include:

In addition, the stock market in general, andthe markets for special purpose acquisition company (“SPAC”) post-business combination businesses and healthcare companiesin particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operatingperformance of these companies. Broad market and industry factors may negatively affect the market price of our Common Stock, regardlessof our actual operating performance. In addition, price volatility may be greater if the public float and trading volume of our CommonStock is low. If the market price of our Common Stock falls, you may not realize any return on your investment and may lose some or allof your investment. In the past, securities class action litigation has often been instituted against companies following periods of volatilityin the market price of a company’s securities. This type of litigation, if instituted, could result in substantial costs and a diversionof management’s attention and resources, which would harm our business, operating results or financial condition.

Unstable market and economic conditions may have serious adverseconsequences on our business, financial condition and stock price.

The global economy, including credit and financialmarkets, has experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, declinesin consumer confidence, declines in economic growth, increases in unemployment rates, increases in inflation rates, higher interest ratesand uncertainty about economic stability. For example, the Russia-Ukraine war and the Israel-Hamas war created volatility in the globalcapital markets and may have further global economic consequences, including disruptions of the global supply chain and energy markets.There have also been disruptions to the U.S. banking system due to bank failures in the past several years, including with respectto Silicon Valley Bank, Signature Bank and First Republic Bank. Any such volatility and disruptions may have adverse consequences on usor the third parties on whom it relies. If the equity and credit markets deteriorate, including as a result of political unrest or war,it may make any necessary debt or equity financing more difficult to obtain in a timely manner or on favorable terms, more costly or moredilutive. Increased inflation rates can adversely affect us by increasing its costs, including labor and employee benefit costs. In addition,higher inflation could also increase customers’ operating costs, which could result in reduced budgets for customers and potentiallyless demand for our products, if and when approved. Any significant increases in inflation and related increase in interest rates couldhave a material adverse effect on our business, results of operations and financial condition.

We do not intend to pay dividends on our Common Stock, so anyreturns will be limited to the value of its stock.

We currently anticipate that we will retain futureearnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends forthe foreseeable future. In addition, future debt or other financing arrangements may contain terms prohibiting or limiting the amountof dividends that may be declared or paid on our Common Stock. Any return to stockholders will therefore be limited in the foreseeablefuture to the appreciation of the market price (if any) of our stock.

We are an “emerging growth company” and a “smallerreporting company”, and the reduced reporting requirements applicable to emerging growth companies and smaller reporting companiesmay make our Common Stock less attractive to investors.

We are an “emerging growth company”within the meaning of the Securities Act, as modified by the JOBS Act. For as long as we continue to be an emerging growth company, wemay take advantage of certain exemptions from various public company reporting requirements that are applicable to other public companiesthat are not emerging growth companies, including being permitted to provide only two years of audited financial statements, in additionto any required unaudited interim financial statements with correspondingly reduced “Management’s Discussion and Analysisof Financial Condition and Results of Operations” disclosure, not being required to have its internal control over financial reportingaudited by our independent registered public accounting firm under Section 404 of the Sarbanes-Oxley Act (“Section 404”),reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and exemptions from therequirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute paymentsnot previously approved. We may take advantage of these exemptions until the last day of the fiscal year ending after the fifth anniversaryof the consummation of our IPO or until we are no longer an emerging growth company, whichever is earlier. We will cease to be an emerginggrowth company prior to the end of such five-year period if certain earlier events occur, including if we become a “large acceleratedfiler” as defined in Rule 12b-2 under the Exchange Act, our annual gross revenues equal or exceed $1.235 billionor we issue more than $1.0 billion of non-convertible debt in any three-year period prior to such time. In particular, in this prospectuson, we have provided only two years of audited financial statements and have not included all of the executive compensation relatedinformation that would be required if it were not an emerging growth company, and it may elect to take advantage of other reduced reportingrequirements in future filings. Accordingly, the information contained herein may be different than the information you receive from otherpublic companies in which you hold stock.

In addition, the JOBS Act provides that an emerginggrowth company can take advantage of an extended transition period for complying with new or revised accounting standards. We have electedto take advantage of the extended transition period to comply with new or revised accounting standards and to adopt certain of the reduceddisclosure requirements available to emerging growth companies. As a result of the accounting standards election, we will not be subjectto the same implementation timing for new or revised accounting standards as other public companies that are not emerging growth companies,which may make comparison of its financials to those of other public companies more difficult. As a result of these elections, the informationthat we provide in this prospectus may be different than the information you may receive from other public companies in which you holdequity interests. In addition, it is possible that some investors will find our Common Stock less attractive as a result of these elections,which may result in a less active trading market for our Common Stock and higher volatility in its share price.

We are also a “smaller reporting company”as defined in the Exchange Act. We may continue to be a smaller reporting company even after we is no longer an emerging growth company.We may take advantage of certain of the scaled disclosures available to smaller reporting companies and will be able to take advantageof these scaled disclosures for so long as our Common Stock held by non-affiliates is less than $250.0 million measured on the lastbusiness day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completedfiscal year and our Common Stock held by non-affiliates is less than $700.0 million measured on the last business day of oursecond fiscal quarter.

Our operating results may fluctuate significantly, which makesfuture operating results difficult to predict and could cause operating results to fall below expectations or guidance.

Our operations to date have been primarily limitedto researching and developing our product candidates. We have not yet obtained regulatory approvals for any of its product candidates.Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longeroperating history or approved products on the market.

Our quarterly and annual operating results mayfluctuate significantly in the future, which makes it difficult for us to predict future operating results. From time to time, we mayenter into license or collaboration agreements with other companies that include development funding and significant upfront and milestonepayments and/or royalties, which may become an important source of our revenue. Accordingly, our revenue may depend on development fundingand the achievement of development and clinical milestones under current and any potential future license and collaboration agreementsand sales of our drugs, if approved. These upfront and milestone payments may vary significantly from period to period and any such variancecould cause a significant fluctuation in operating results from one period to the next.

In addition, our measures compensation cost forstock-based awards made to employees, directors and non-employee consultants based on the fair value of the award on the grant date andwe recognize the cost as an expense over the requisite service period, as applicable. Because the variables that we uses as a basis forvaluing stock-based awards change over time, including our underlying stock price and stock price volatility, the magnitude of the expensethat we must recognize may vary significantly.

Furthermore, operating results may fluctuate dueto a variety of other factors, many of which are outside of our control and may be difficult to predict, including the following:

The cumulative effect of such factors could resultin large fluctuations and unpredictability in quarterly and annual operating results. As a result, comparing operating results on a period-to-periodbasis may not be meaningful. Investors should not rely on past results as an indication of future performance. This variability and unpredictabilitycould also result in our failing to meet the expectations of industry or financial analysts or investors for any period. If our revenueor operating results fall below the expectations of analysts or investors or below any forecasts we may provide to the market, or if theforecasts we provide to the market are below the expectations of analysts or investors, the price of our Common Stock could decline substantially.Such a stock price decline could occur even when we have met any previously publicly stated revenue and/or earnings guidance we may provide.

Anti-takeover provisions under our organizational documents andDelaware law could delay or prevent a change of control which could limit the market price of our Common Stock and may prevent or frustrateattempts by our stockholders to replace or remove our then-current management.

Our Charter and Bylaws, contain provisions thatcould delay or prevent a change of control of our board of directors that our stockholders might consider favorable. Some of these provisionsinclude:

In addition, because we are incorporated in Delaware,we are governed by the provisions of Section 203 of the DGCL, which may prohibit certain business combinations with stockholdersowning 15% or more of our outstanding voting stock. These anti-takeover provisions and other provisions in our Charter or Bylaws couldmake it more difficult for stockholders or potential acquirors to obtain control of our board of directors or initiate actions that areopposed by the then-current board of directors and could also delay or impede a merger, tender offer, or proxy contest. These provisionscould also discourage proxy contests and make it more difficult for you and other stockholders to elect directors of your choosing orcause us to take other corporate actions you desire. Any delay or prevention of a change of control transaction or changes in our boardof directors could cause the market price of our Common Stock to decline.

If we engage in future acquisitions or strategic partnerships,this may increase capital requirements, dilute stockholders, cause us to incur debt or assume contingent liabilities, and subject us toother risks.

We intend to evaluate various acquisition opportunitiesand strategic partnerships, including licensing or acquiring complementary drugs, intellectual property rights, technologies or businesses.Any potential acquisition or strategic partnership may entail numerous risks, including:

In addition, if we undertake acquisitions, wemay issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that couldresult in significant future amortization expense. Moreover, we may not be able to locate suitable acquisition opportunities, and thisinability could impair our ability to grow or obtain access to technology or products that may be important to the development of ourbusiness.

Our Bylaws provide that the Court of Chancery of the State ofDelaware and, to the extent enforceable, the federal district courts of the United States of America will be the exclusive forums forsubstantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicialforum for disputes with us or our directors, officers, or employees.

The Charter provides that, unless we consent tothe selection of an alternative forum, the Court of Chancery of the State of Delaware is the exclusive forum for the following types ofactions or proceedings under Delaware statutory or common law:

This provision would not apply to suits broughtto enforce a duty or liability created by the Exchange Act. Furthermore, Section 22 of the Securities Act creates concurrentjurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federal courts have jurisdictionto entertain such claims. To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistent or contrary rulingsby different courts, among other considerations, the Charter further provides that, unless we consent to the selection of an alternativeforum, the federal district courts of the United States of America will be the exclusive forum for resolving any complaint assertinga cause of action arising under the Securities Act, including all causes of action asserted against any defendant named in such complaint.While the Delaware courts have determined that such choice of forum provisions are facially valid and several state trial courts haveenforced such provisions and required that suits asserting Securities Act claims be filed in federal court, there is no guarantee thatcourts of appeal will affirm the enforceability of such provisions and a stockholder may nevertheless seek to bring a claim in a venueother than those designated in the exclusive forum provisions. In such instance, we would expect to vigorously assert the validity andenforceability of the exclusive forum provisions of the Charter. This may require significant additional costs associated with resolvingsuch action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in those other jurisdictions.If a court were to find either exclusive forum provision in the Charter to be inapplicable or unenforceable in an action, we may incurfurther significant additional costs associated with litigating Securities Act claims in state court, or both state and federal court,which could seriously harm our business, financial condition, results of operations, and prospects. These exclusive forum provisions maylimit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or our directors,officers, or other employees, or could result in increased costs for a stockholder to bring a claim, particularly if they do not residein or near Delaware, both of which may discourage lawsuits against us and our directors, officers and other employees. If a court wereto find either exclusive forum provision in the Charter to be inapplicable or unenforceable in an action, we may incur further significantadditional costs associated with resolving the dispute in other jurisdictions, all of which could seriously harm our business.

We will incur increased costs and demands upon management asa result of complying with the laws and regulations affecting public companies, which could adversely affect our business, results ofoperations, and financial condition.

As a public company, we are subject to the reportingrequirements of the Exchange Act, the listing standards of Nasdaq, and other applicable securities rules and regulations. We expect thatthe requirements of these rules and regulations will continue to increase our legal, accounting and financial compliance costs, make someactivities more difficult, time-consuming and costly, and place significant strain on our personnel, systems and resources. For example,the Exchange Act requires, among other things, that we file annual, quarterly and current reports with respect to our business and resultsof operations. As a result of the complexity involved in complying with the rules and regulations applicable to public companies, ourmanagement’s attention may be diverted from other business concerns, which could harm our business, results of operations and financialcondition. Although we have already hired additional employees to assist us in complying with these requirements, we may need to hiremore employees in the future or engage outside consultants, which will increase our operating expenses.

In addition, changing laws, regulations and standardsrelating to corporate governance and public disclosure are creating uncertainty for public companies, increasing legal and financial compliancecosts, and making some activities more time-consuming. These laws, regulations and standards are subject to varying interpretations, inmany cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is providedby regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitatedby ongoing revisions to disclosure and governance practices. We intend to invest substantial resources to comply with evolving laws, regulationsand standards, and this investment may result in increased general and administrative expenses and a diversion of management’s timeand attention from business operations to compliance activities. If our efforts to comply with new laws, regulations and standards differfrom the activities intended by regulatory or governing bodies due to ambiguities related to their application and practice, regulatoryauthorities may initiate legal proceedings against us and our business may be harmed.

We also expect that being a public company andthese new rules and regulations will make it more expensive for us to obtain director and officer liability insurance, and we may be requiredto accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also make it more difficult forus to attract and retain qualified members of our board of directors, particularly to serve on our audit committee (the “Audit Committee”)and compensation committee (the “Compensation Committee”), and qualified executive officers.

As a result of disclosure of information in thefilings required of a public company, our business and financial condition will become more visible, which may result in an increasedrisk of threatened or actual litigation, including by competitors and other third parties. If such claims are successful, our businessand results of operations could be harmed, and even if the claims do not result in litigation or are resolved in our favor, these claims,and the time and resources necessary to resolve them, could divert the resources of our management and harm our business, results of operations,and financial condition.

As a result of becoming a public company, we are obligated todevelop and maintain proper and effective internal controls over financial reporting and any failure to maintain the adequacy of theseinternal controls may adversely affect investor confidence in our company and, as a result, the value of our common stock.

We are required, pursuant to Section 404,to furnish a report by management on, among other things, the effectiveness of our internal controls over financial reporting. In 2026,five years after our IPO, we may be required to comply with auditor attestation requirements, as required by Section 404. This willrequire that we incur substantial additional professional fees and internal costs to expand our accounting and finance functions and thatwe expend significant management efforts.

We may identify weaknesses in our system of internalfinancial and accounting controls and procedures that could result in a material misstatement of our consolidated financial statements.Our control over financial reporting will not prevent or detect all errors and all fraud. A control system, no matter how well designedand operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will be met. Because ofthe inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatements due to erroror fraud will not occur or that all control issues and instances of fraud will be detected.

Any failure to maintain internal control overfinancial reporting could severely inhibit our ability to accurately report our financial condition, results of operations or cash flows.If our financial statements are not accurate, investors may not have a complete understanding of our operations. If we do not file financialstatements on a timely basis as required by the SEC, we could face severe consequences. If we are unable to conclude that its internalcontrol over financial reporting is effective, investors may lose confidence in the accuracy and completeness of our financial reports,the market price of our Common Stock could decline, and we could be subject to sanctions or investigations by the Nasdaq, the SEC or otherregulatory authorities. Moreover, responding to such investigations, are likely to consume a significant amount of our management resourcesand cause us to incur significant legal and accounting expenses. Failure to remedy any material weakness in internal control over financialreporting, or to maintain effective control systems, could also restrict our future access to the capital markets. This could result inan adverse reaction in the financial markets due to a loss of confidence in the reliability of our financial statements.

As a public reporting company, we are subject to filing deadlinesfor reports that we file pursuant to the Exchange Act, and our failure to timely file such reports may have material adverse consequenceson our business.

Following the consummation of the Business Combination,we failed to timely file our Form 8-K with Form 10 information prior to the “staleness” date (as determined in accordancewith the applicable rules and regulations of the SEC) applicable to the financial statements that were required by the applicable accountingrequirements and other rules and regulations of the SEC to be included in such filing (including pro forma financial information); thus,we have not remained current in our reporting requirements with the SEC since we became an SEC reporting company on February 14, 2024.Although we have since regained status as a current filer by filing a Form 8-K/A with current financial statements on April 1, 2024, wewill not be eligible to use a registration statement on Form S-3 that would allow us to continuously incorporate by reference our SECreports into the registration statement, or to use “shelf” registration statements to conduct offerings, until approximatelyone year from the date we regained (and maintain) status as a current filer. Until such time, if we determine to pursue an offering, wewould be required to conduct the offering on an exempt basis, such as in accordance with Rule 144A, or file a registration statement onForm S-1. Using a Form S-1 registration statement for a public offering would likely take significantly longer than using a registrationstatement on Form S-3 and increase our transaction costs, and could, to the extent we are not able to conduct offerings using alternativemethods, adversely impact our liquidity, ability to raise capital or complete acquisitions in a timely manner. The use of Form S-1 wouldalso prevent us from conducting offerings on a “shelf basis,” limiting our flexibility as to the terms, timing or manner ofany such offering.

We cannot guarantee that in the future our reportingwill always be timely. If we are unable to satisfy SEC filing deadlines or otherwise provide disclosures of material information on atimely basis, stockholders and potential investors in our Common Stock may have incomplete information about our business and resultsof operations, which may impact their ability to make an informed investment decision, result in a reduction in the trading price, tradingvolume or analyst coverage of our Common Stock or expose us to potential liability.

We could be subject to securities class action litigation.

In the past, securities class action litigationhas often been brought against a company following a decline in the market price of its securities. This risk is especially relevant forus because biopharmaceutical companies have experienced significant stock price volatility in recent years. If we face such litigation,it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

Any such negative outcome could result in paymentsof substantial damages or fines, damage to our reputation or adverse changes to our business practices. Defending against litigation iscostly and time-consuming, and could divert management’s attention and our resources. Furthermore, during the course of litigation,there could be negative public announcements of the results of hearings, motions or other interim proceedings or developments, which couldhave a negative effect on the market price of the our Common Stock.

Our failure to meet the continued listing requirements of Nasdaqcould result in a delisting of its securities.

If we fail to satisfy the continued listing requirementsof Nasdaq, such as the corporate governance requirements or the minimum share price requirement, Nasdaq may take steps to delist our securities.Such a delisting would likely have a negative effect on the price of the securities and would impair your ability to sell or purchasethe securities when you wish to do so. In the event of a delisting, any action taken by us to restore compliance with listing requirementsmay not allow our securities to become listed again, stabilize the market price or improve the liquidity of our securities, prevent oursecurities from dropping below the Nasdaq minimum share price requirement or prevent future non-compliance with Nasdaq’s listingrequirements. Additionally, if our securities are not listed on, or become delisted from Nasdaq for any reason, and are quoted on theover-the-counter bulletin board, an inter-dealer automated quotation system for equity securities that is not a national securities exchange,the liquidity and price of our securities may be more limited than if we were quoted or listed on Nasdaq or another national securitiesexchange.

If securities or industry analysts do not publish research, orpublish inaccurate or unfavorable research, about our business, our Common Stock share price and trading volume could decline.

The trading market for our Common Stock will depend,in part, on the research and reports that securities or industry analysts publish about us or our business. If few or no securities orindustry analysts cover us, the trading price for our Common Stock would likely be negatively impacted. If one or more of the analystswho cover us downgrade our Common Stock or publish inaccurate or unfavorable research about our business, our share price would likelydecline. In addition, if our operating results fail to meet the forecast of analysts, our share price would likely decline. If one ormore of these analysts cease coverage of us or fail to publish reports on us regularly, demand for our Common Stock could decrease, whichmight cause our share price and trading volume to decline.

Future sales of our Common Stock, or the perception that futuresales may occur, may cause the market price of our Common Stock to decline, regardless of our operating performance.

Due to the significant number of redemptions ofClass A Common Stock, in connection with the Business Combination, there was a significantly lower number of shares of Class A CommonStock that converted into shares of our Common Stock in connection with the Business Combination. As a result, the shares of our CommonStock being registered for resale are anticipated to constitute a considerable percentage of our public float. Additionally, a significantportion of the shares of our Common Stock being registered for resale were purchased by Selling Securityholders pursuant to investmentsin Legacy CERo that date from February 2017 onwards at prices considerably below the current market price of our Common Stock. This discrepancyin purchase prices may have an impact on the market perception of our Common Stock’s value and could increase the volatility ofthe market price of our Common Stock or result in a significant decline in the public trading price of our Common Stock. The registrationof these shares for resale creates the possibility of a significant increase in the supply of our Common Stock in the market. The increasedsupply, coupled with the potential disparity in purchase prices, may lead to heightened selling pressure, which could negatively affectthe public trading price of our Common Stock. We will not receive the proceeds from the resale of the shares of Common Stock by the SellingSecurityholders.

Sales of a substantial number of our shares ofCommon Stock and/or Public Warrants in the public market by our existing securityholders, or the perception that those sales might occur,could depress the market price of our shares of Common Stock and Public Warrants and could impair our ability to raise capital throughthe sale of additional equity securities. We are unable to predict the effect that such sales may have on the prevailing market priceof our shares of Common Stock and Public Warrants. Furthermore, the sale of a substantial number of shares of Common Stock pursuant tothis prospectus, or the perception that such sale may occur, may materially and adversely affect the prevailing market price of our CommonStock and thus restrict the amount we are able to raise in an equity offering, or require us to issue and sell more Common Stock to generatethe same amount of gross proceeds than we would otherwise have had to, which would result in greater dilution to our existing stockholders.We expect that because there is a large number of shares being registered pursuant to the registration statement of which this prospectusforms a part, the holders thereunder will continue to offer the securities covered thereby for a significant period of time, the preciseduration of which cannot be predicted. Accordingly, the adverse market and price pressures and constraint on our ability to raise additionalcapital resulting from the shares registered hereunder may continue for an extended period of time.

Our Warrants are exercisable for Common Stock, the exercise ofwhich would increase the number of shares eligible for future resale in the public market and result in dilution to our shareholders.

As of October 8, 2024, there were 18,667,770Common Warrants with an exercise price ranging from $1.39 to $11.50 per share, which are exercisable into 18,667,770 shares ofCommon Stock. To the extent such warrants are exercised, additional shares of our Common Stock will be issued, which will result indilution to the holders of our Common Stock and increase the number of shares eligible for resale in the public market. Sales ofsubstantial numbers of such shares in the public market could adversely affect the market price of our Common Stock, the impact ofwhich increases as the value of our stock price increases.

Our Warrants may not be exercised at all and we may not receiveany cash proceeds from the exercise of the Warrants.

Holders of our Warrants will be less likely toexercise their Warrants if the exercise prices of their Warrants exceed the market price of our Common Stock. There is no guarantee thatour Warrants will continue to be in the money prior to their expiration, and as such, the Warrants may expire worthless. As such, anycash proceeds that we may receive in relation to the exercise of the Warrants overlying shares of Common Stock will be dependent on thetrading price of our Common Stock. There is no assurance that the holders of the Warrants will elect to exercise any or all of such Warrants.As of the date of this prospectus (i) all of the Private Placement Warrants and Public Warrants, which have an exercise price of $11.50per share, (ii) all of the Rollover Warrants, which have an exercise price of $10.00 per share, and (iii) all of the Series A Warrants,which have a current exercise price of $1.39 per share, are “out of the money,” meaning the exercise price is higher thanthe market price of our Common Stock. Holders of such “out of the money” Warrants are not likely to exercise such Warrants.There can be no assurance that such Warrants will be in the money prior to their respective expiration dates, and therefore, we may notreceive any cash proceeds from the exercise of such Warrants.

Our Earnout Shares are accounted for as liabilities and the changesin value of such shares could have a material effect on, or cause volatility in, our financial results.

We evaluated the accounting treatment of our EarnoutShares (as defined below) subject to forfeiture if the applicable conditions to transferability thereof are not satisfied and determinedto classify such shares as liabilities measured at fair value. The fair value of such shares is remeasured on a quarterly basis over theearn-out period with changes in the estimated fair value recorded in Other (expense) income on the condensed consolidated statement ofoperations and comprehensive loss. Due to the recurring fair value measurement, we expect that we will recognize non-cash gains or losseson our Earnout Shares each reporting period and that the amount of such gains or losses could materially impact or cause volatility inour financial results.

USE OFPROCEEDS

All of the Common Stock offered by the SellingSecurityholders pursuant to this prospectus will be sold by the Selling Securityholders for their respective accounts. We will not receiveany of the proceeds from these sales.

The Selling Securityholders will pay any underwritingfees, discounts, selling commissions, stock transfer taxes and certain legal expenses incurred by such Selling Securityholders in disposingof their shares of Common Stock, and we will bear all other costs, fees and expenses incurred in effecting the registration of such securitiescovered by this prospectus, including, without limitation, all registration and filing fees, Nasdaq listing fees, and fees and expensesof our counsel and our independent registered public accountants.

We could potentially receive (i) up to an aggregateof $0.8 million in proceeds from the exercise of the Series C Warrants, assuming the exercise in full of all of the Series C Warrantsfor cash and (ii) up to an aggregate of $2.0 million in proceeds from the exercise of the Preferred Warrants, assuming the exercise infull of all of the Series C Warrants and Preferred Warrants for cash. We will not receive any of the proceeds from the resale of the sharesof Common Stock issuable upon the exercise of the Series C Warrants, or the resale of the shares of Common Stock issuable upon the exerciseof the Preferred Warrants and conversion of the underlying shares of Series A Preferred Stock into Common Stock. 

We intend to use any net proceeds we may receivefrom any exercise of the Preferred Warrants or Series C Warrants for working capital and other general corporate purposes. We will havebroad discretion over the use of any proceeds from any exercise of the Preferred Warrants or Series C Warrants. Pending other uses,we may invest the net proceeds to us in investment-grade, interest-bearing securities such as money market funds, certificates of deposit,or direct or guaranteed obligations of the U.S. government, or hold as cash. We cannot predict whether the net proceeds invested willyield a favorable return.

There is no assurance that the holdersof the Warrants will elect to exercise any or all of such Warrants. As of the date of this prospectus, (i) all of the Private PlacementWarrants and Public Warrants, which have an exercise price of $11.50 per share, (ii) all of the Rollover Warrants, which have an exerciseprice of $10.00 per share, and (iii) all of the Series A Warrants, which have a current exercise price of $1.39 per share, are “outof the money,” meaning the exercise price is higher than the market price of our Common Stock. Holders of such “outof the money” Warrants are not likely to exercise such Warrants. There can be no assurance that such Warrants will be in the moneyprior to their respective expiration dates, and therefore, we may not receive any cash proceeds from the exercise of such Warrants. See “RiskFactors—Certain existing securityholders purchased our securities at a price below the current trading price of such securities,and may experience a positive rate of return based on the current trading price. Future investors in us may not experience a similarrate of return” for additional information. 

DETERMINATIONOF OFFERING PRICE

We cannot currently determine the price or pricesat which the shares of our Common Stock may be sold by the Selling Securityholders under this prospectus. Our Common Stock is listed onNasdaq under the symbol “CERO” and our Public Warrants are listed on Nasdaq under the symbol “CEROW.”

MARKETPRICE AND DIVIDEND INFORMATION

Market Price

Our Common Stock and Public Warrants are listedon Nasdaq under the symbols “CERO” and “CEROW,” respectively.

The closing price of our Common Stock and ourPublic Warrants as reported on Nasdaq on October 8, 2024 was $0.098 per share and $0.0087 per warrant.

Holders

As of October 8, 2024, there were 143 holdersof record of our Common Stock and 34 holders of record of our Public Warrants. The numbers of holders of record do not include for examplea substantially greater number of “street name” holders or beneficial holders whose securities are held of record by banks,brokers and other financial institutions.

Dividend Policy

We have not paid any cash dividends to date. Thepayment of cash dividends in the future will be dependent upon our revenues and earnings, if any, capital requirements, and general financialcondition. The payment of any cash dividends will be within the discretion of our Board at such time.

UNAUDITEDPRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION

PBAX, and after the Business Combination, CERo,is providing the following unaudited pro forma condensed combined financial information to aid you in your analysis of the financial aspectsof the Business Combination and related transactions. The following unaudited pro forma condensed financial information presents the combinationof the financial information of PBAX and Legacy CERo adjusted to give effect to the Business Combination and related transactions. Thefollowing unaudited pro forma condensed combined financial information has been prepared in accordance with Article 11 of Regulation S-Xas amended by the final rule, Release No. 33-10786 “Amendments to Financial Disclosures about Acquired and Disposed Businesses.”

The historical financial information of PBAX wasderived from the audited financial statements of PBAX for the year ended December 31, 2023. The historical financial information of LegacyCERo was derived from audited financial statements of Legacy CERo for the year ended December 31, 2023. Such unaudited pro forma financialinformation has been prepared on a basis consistent with the audited financial statements of PBAX and Legacy CERo, respectively, and shouldbe read in conjunction with the audited historical financial statements and related notes.

The unaudited pro forma condensed combined balancesheet as of December 31, 2023, combines the historical balance sheet of PBAX and the historical balance sheet of Legacy CERo on a proforma basis as if the Business Combination and the related transactions contemplated by the Business Combination Agreement, summarizedbelow, had been consummated on December 31, 2023. The unaudited pro forma condensed combined statement of operations for the year endedDecember 31, 2023 combines the historical statement of operations of PBAX and historical statement of operations of Legacy CERo on a proforma basis as if the Business Combination and the transactions contemplated by the Business Combination Agreement, summarized below,had been consummated on January 1, 2023. There were no pro forma adjustments required to eliminate activities between the companies.

These unaudited pro forma condensed combined financialstatements are for informational purposes only. They do not purport to indicate the results that would have been obtained had the BusinessCombination and related transactions actually been completed on the assumed date or for the period presented, or which may be realizedin the future. The pro forma adjustments are based on the information currently available and the assumptions and estimates underlyingthe pro forma adjustments are described in the accompanying notes. Actual results may differ materially from the assumptions within theaccompanying unaudited pro forma condensed combined financial information.

On June 6, 2023, PBAX entered into a BusinessCombination Agreement with Merger Sub and Legacy CERo, pursuant to which Merger Sub merged with and into Legacy CERo, with Legacy CERosurviving as a wholly-owned subsidiary of the CERo. The Business Combination Agreement was amended on February 5, 2024 and again on February13, 2024. The Business Combination closed on February 14, 2024, at which time the following occurred:

CERo issued, transferred from the Sponsor, orreserved for issuance an aggregate of 8.4 million shares of Class A Common Stock to the holders of Legacy CERo common stock and LegacyCERo preferred stock or reserved for issuance upon exercise of Legacy CERo options or warrants as consideration in the Business Combination.In connection with the Business Combination, PBAX changed its name to “CERo Therapeutics Holdings, Inc.”

The unaudited pro forma condensed combined financialinformation has been prepared using the assumptions below:

On June 4, 2023, Legacy CERo entered into a bridgefinancing agreement (the “Bridge Financing”) in anticipation of Legacy CERo completing the Business Combination with PBAXpursuant to a definitive Business Combination Agreement. On June 6, 2023, Legacy CERo sold the Convertible Bridge Notes with an aggregateprincipal amount of $605,230 to certain eligible participants. The Convertible Bridge Notes were automatically converted (principal andaccrued interest) upon the Business Combination into an aggregate of 628 shares of Series A Preferred Stock at conversion rate of $1,000per share, and all of the Convertible Bridge Notes were retired.

An additional 1,000,000 shares of restricted CommonStock were issued to select Legacy CERo Stockholders and Convertible Bridge Note investors and a corresponding 1,000,000 shares of CommonStock held by the Sponsor have been restricted. Upon the filing of an investigational new drug (“IND”) application with theFDA, the restrictions upon the shares of Common Stock issued to such Legacy CERo Stockholders and Convertible Bridge Note investors willbe removed, and the shares of Common Stock held by the Sponsor will be retired. Should CERo fail to file an IND with the FDA, the sharesof Common Stock issued to such Legacy CERo Stockholders and Convertible Bridge Note investors will be retired and the restrictions onthe Sponsor’s Common Stock will be removed.

Of the 2,000,000 shares of Common Stock held bySponsor, 250,000 shares were transferred to a key investor, 875,000 shares were distributed to select Legacy CERo Stockholders and ConvertibleBridge Note investors as earnout shares, and 875,000 shares being retained by the Sponsor.

CERo also issued 1,943,550 new shares ofCommon Stock in connection with the Business Combination, consisting of (i) 1,649,500 shares issued to select vendors in lieu of cashpayment for services provided related to the Business Combination, (ii) 175,000 shares provided to individuals as compensation and (iii)119,050 shares issued to Keystone as consideration for its entry into the Keystone Equity Financing.

Additionally, in February 2024, CERo consummateda private placement of 10,039 shares of Series A Preferred Stock, warrants to purchase 612,746 shares of Series A Warrants and warrantsto purchase 2,500 shares of Preferred Warrants, pursuant to the Amended and Restated Securities Purchase Agreement, dated February 14,2024, by and among PBAX, Legacy CERo and the Initial Investors for aggregate cash proceeds to CERo of approximately $8.0 million, plusadditional cash proceeds of $2.0 million on the mandatory exercise of the Preferred Warrants on the registration of the underlying commonshares. A portion of such Series A Preferred Stock was issued as consideration for the cancellation of outstanding indebtedness or securitiesof PBAX or Legacy CERo, including a promissory note of PBAX and the Convertible Bridge Notes.

In addition, CERo entered into a side letter withKeystone, pursuant to which CERo agreed to make a payment of $1.0 million to Keystone, which amount reflects an original issue discountto Keystone, and to reimburse $150,000 of legal expenses incurred thereby. In addition, the Sponsor agreed to transfer an aggregate of250,000 shares of Class A Common Stock to another investor as consideration for their participation in the PIPE Financing.

On February 14, 2024, as a condition to the closingof the PIPE Financing, CERo entered into the Keystone Purchase Agreement with Keystone, pursuant to which CERo may sell and issue, andKeystone is obligated to purchase, up to the lesser of $25 million of Common Stock or a limit determined by maximum ownership percentages(the “Keystone Equity Financing”). On February 23, 2024, CERo entered into Arena Purchase Agreement, pursuant to which CERomay sell and issue, subsequent to the Keystone Equity Financing being terminated or fully subscribed, and Arena is obligated to purchase,up to $25 million of Common Stock or a limit determined by maximum ownership percentages. Each of the Keystone Equity Financing and ArenaEquity Financing is in place, but there was no accounting impact on the date of the transaction.

The following summarizes the pro forma ownershipof Common Stock following the Business Combination:

The Business Combination is being accounted forusing the asset acquisition method in accordance with accounting principles generally accepted in the United States of America (“U.S.GAAP”). Under this method of accounting, we have determined that PBAX is the accounting acquirer as PBAX is (i) the entity issuingits own shares to consummate the Business Combination, (ii) the senior management team will primarily be comprised of PBAX’s existingmanagement team, and (iii) PBAX’s assets were significantly larger than Legacy CERo’s, based on the terms of the BusinessCombination Agreement. The merger is being accounted for as an asset acquisition as substantially all of the fair value is concentratedwithin in-process research and development (“IPR&D”), an intangible asset. Legacy CERo’s assets (except for cash)and liabilities will be measured and recognized as an allocation of the transaction price based on their relative fair values as of thetransaction date with any value associated with IPR&D with no alternative future use being expensed.