As filedwith the Securities and Exchange Commission on November 26, 2024

RegistrationNo. 333-                 

UNITEDSTATES

SECURITIESAND EXCHANGE COMMISSION

Washington,D.C. 20549

FORM S-1

REGISTRATIONSTATEMENT

UNDER

THESECURITIES ACT OF 1933

CERO THERAPEUTICSHOLDINGS, INC. 

(Exactname of registrant as specified in its charter)

201 HaskinsWay, Suite 230

SouthSan Francisco, CA 94080

(215)731-9450

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

ChrisEhrlich

InterimChief Executive Officer

CERo TherapeuticsHoldings, Inc.

201 HaskinsWay, Suite 230

SouthSan Francisco, CA 94080

Telephone:(215) 731-9450 

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

Copiesto:

StephenM. Davis

JeffreyA. Letalien

GoodwinProcter LLP

620 EighthAvenue

New York,NY 10018

(212)813-8800

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

If any of the securities beingregistered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933 checkthe following box: ☒

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

If this Form is a post-effectiveamendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statementnumber of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effectiveamendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statementnumber of the earlier effective registration statement for the same offering. ☐

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

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

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

The information inthis preliminary prospectus is not complete and may be changed. These securities may not be issued until the registration statement filedwith the U.S. Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities anddoes not constitute the solicitation of an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

SUBJECT TO COMPLETION,DATED NOVEMBER 26, 2024

PRELIMINARY PROSPECTUS

CERO THERAPEUTICS HOLDINGS, INC.

Up to 210,000,000 Shares of Common Stock

This prospectus relates tothe potential offer and sale from time to time by Keystone Capital Partners, LLC (“Keystone”) of up to 210,000,000 sharesof common stock, par value $0.0001 per share (the “Common Stock”), that have been or may be issued by us to Keystone, including(i) 208,635,705 shares of Common Stock that we may elect, in our sole discretion, to issue and sell to Keystone, from time to time fromand after the Keystone Commencement Date (as defined below) pursuant to a Common Stock Purchase Agreement, dated as of November 8, 2024,by and between us and Keystone (the “New Keystone Purchase Agreement”) and (ii) 1,364,295 shares of Common Stock that havebeen issued to Keystone pursuant to a Common Stock Purchase Agreement, dated as of February 14, 2024, by and between us and Keystone (the“Old Keystone Purchase Agreement” and, together with the New Keystone Purchase Agreement, the “Keystone Purchase Agreements”),as consideration for it establishing an equity line of credit (the “Keystone Equity Financing”).

Asof the date of this prospectus, we have issued and sold 23,377,921 shares of Common Stock (the “Old Keystone Purchase Shares”)for aggregate proceeds of $4,410,616 under the Keystone Equity Financing. We previously filed a registration statement on Form S-1 (FileNo. 333-278603), which was declared effective by the SEC on May 1, 2024, and remains in effect (the “Prior Registration Statement”),with respect to up to (i) 25,000,000 Keystone Purchase Shares and (ii) 619,050 Keystone Commitment Shares.

The actual number of sharesof our Common Stock issuable will vary depending on the then-current market price of shares of our Common Stock sold to Keystone underthe Keystone Purchase Agreements, but will not exceed the number set forth in the preceding sentences unless we file an additional registrationstatement under the Securities Act of 1933, as amended (the “Securities Act”), withthe Securities and Exchange Commission (the “SEC”). See “The Committed Equity Financing” for a descriptionof the Keystone Purchase Agreements and “Selling Securityholder” for additional information regarding Keystone.

We are not selling any securitiesunder this prospectus and will not receive any of the proceeds from the sale of the shares of our Common Stock by Keystone. Additionally,we will not receive any proceeds from the issuance or sale of the Keystone Commitment Shares. We may receive up to $25.0 millionin aggregate gross proceeds from Keystone under the Keystone Purchase Agreements (as defined below) in connection with sales of the sharesof our Common Stock to Keystone pursuant to the Keystone Purchase Agreements, including the Old Keystone Purchase Shares and any sharesof our Common Stock sold after the date of this prospectus. However, the actual proceeds from Keystone may be less than this amount dependingon the number of shares of our Common Stock sold and the price at which the shares of our Common Stock are sold.

As of November 21, 2024,there were 278,857,958 shares of Common Stock outstanding on a fully-diluted basis after giving effect to the conversion of all outstandingshares of our Series A Preferred Stock, Series B Preferred Stock and Series C Preferred Stock (each as defined below) and the exerciseof all outstanding Warrants and options (as defined below), of which 152,236,773 shares were held by non-affiliates (without taking intoaccount beneficial ownership or stock exchange limitations). If all of the 210,000,000 shares of our Common Stock offered for resale byKeystone under this prospectus were issued and outstanding as of November 21, 2024 (without taking into account beneficial ownership orstock exchange limitations), such shares would represent approximately 43.0% of total number of shares of our fully-diluted Common Stockoutstanding and approximately 58.3% of the total number of shares of our fully-diluted Common Stock outstanding held by non-affiliates.

This prospectus providesyou with a general description of such securities and the general manner in which Keystone may offer or sell the securities. More specificterms of any securities that Keystone may offer or sell may be provided in a prospectus supplement that describes, among other things,the specific amounts and prices of the securities being offered and the terms of the offering. The prospectus supplement may also add,update or change information contained in this prospectus.

Keystone may offer, sellor distribute all or a portion of the shares of our Common Stock acquired under the Keystone Purchase Agreements and hereby registeredpublicly or through private transactions at prevailing market prices or at negotiated prices. We will bear all costs, expenses and feesin connection with the registration of the shares of our Common Stock, including with regard to compliance with state securities or “bluesky” laws. The timing and amount of any sales are within the sole discretion of Keystone. Keystone isan underwriter under the Securities Act with respect to the resale of shares held by it. Although Keystone is obligated topurchase shares of our Common Stock under the terms and subject to the conditions and limitations of the Keystone Purchase Agreementsto the extent we choose to sell such shares of our Common Stock to it (subject to certain conditions), there can be no assurances thatwe will choose to sell any shares of our Common Stock to Keystone, or that Keystone will sell any or all of the shares of our CommonStock, if any, purchased under the Keystone Purchase Agreements pursuant to this prospectus. Keystone will bear all commissions and discounts,if any, attributable to its sale of shares of our Common Stock. See “Plan of Distribution.”

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

Our Common Stock is listedon Nasdaq under the symbol “CERO.” On November 26, 2024, the last quoted sale price for the shares of our Common Stockas reported on the Nasdaq was $0.1735 per share.

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

 Investing in oursecurities involves a high degree of risk. Before buying any securities, you should carefully read the discussion of the risks of investingin our securities in “Risk Factors” beginning on page 7 of this prospectus.

Neither the Securitiesand Exchange Commission nor any state securities commission has approved or disapproved of the securities to be issued under this prospectusor determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The date of this prospectusis     , 2024.

TABLE OF CONTENTS

ABOUTTHIS PROSPECTUS

This prospectus is part ofa registration statement on Form S-1 that we filed with the SEC whereby the Selling Securityholder named herein may, from timeto time, sell the securities offered by them described in this prospectus. We will not receive any proceeds from the sale by such SellingSecurityholder of the securities offered by them described in this prospectus.

Neither we nor the SellingSecurityholder have authorized anyone to provide you with any information or to make any representations other than those contained inthis prospectus or any applicable prospectus supplement or any free writing prospectuses prepared by or on behalf of us or to which wehave referred you. Neither we nor the Selling Securityholder take responsibility for, and can provide no assurance as to the reliabilityof, any other information that others may give you. Neither we nor the Selling Securityholder will make an offer to sell these securitiesin any jurisdiction where such offer or sale is not permitted. No dealer, salesperson or other person is authorized to give any informationor to represent anything not contained in this prospectus, any applicable prospectus supplement or any related free writing prospectus.You should assume that the information appearing in this prospectus or any prospectus supplement is accurate as of the date on the frontof those documents only, regardless of the time of delivery of this prospectus or any applicable prospectus supplement, or any sale ofa security. Our business, financial condition, results of operations and prospects may have changed since those dates.

The Selling Securityholderand its permitted transferees may use this registration statement to sell securities from time to time through any means described inthe section titled “Plan of Distribution.” More specific terms of any securities that the Selling Securityholder andits permitted transferees offer and sell may be provided in a prospectus supplement that describes, among other things, the specific amountsand prices of the securities being offered and the terms of the offering.

We may also provide a prospectussupplement or post-effective amendment to the registration statement to add information to, or update or change information containedin, this prospectus. Any statement contained in this prospectus will be deemed to be modified or superseded for purposes of this prospectusto the extent that a statement contained in such prospectus supplement or post-effective amendment modifies or supersedes such statement.Any statement so modified will be deemed to constitute a part of this prospectus only as so modified, and any statement so supersededwill be deemed not to constitute a part of this prospectus. You should read both this prospectus and any applicable prospectus supplementor post-effective amendment to the registration statement together with the additional information to which we refer you in the sectionsof this prospectus titled “Where You Can Find More Information.”

This prospectus containssummaries of certain provisions contained in some of the documents described herein, but reference is made to the actual documents forcomplete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referredto herein have been filed or will be filed as exhibits to the registration statement of which this prospectus is a part (the “CurrentRegistration Statement”), and you may obtain copies of those documents as described below under “Where You Can Find MoreInformation.”

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

Unless the context otherwiserequires, all references herein to “CERo,” “we,” “us,” or “our” refer to the businessand operations of Legacy CERo and its consolidated subsidiaries prior to consummation of the Business Combination and to CERo and itsconsolidated subsidiaries following the consummation of the Business Combination. “Legacy CERo” refers to CERo Therapeutics,Inc. prior to the consummation of the Business Combination.

MARKETAND INDUSTRY INFORMATION

Certain information containedin this document relates to or is based on studies, publications, surveys and other data obtained from third-party sources and our owninternal estimates and research. We believe these third-party sources to be reliable as of the date of this prospectus and we are responsiblefor 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 informationand data cannot always be verified with complete certainty due to limits on the availability and reliability of raw data, the voluntarynature of the data gathering process and other limitations and uncertainties inherent in any statistical survey. Additionally, while ourown internal research has not been verified by any independent source, we believe such research to be reliable and are responsible forany information disclosed in this prospectus based upon such internal research.

TRADEMARKS

This document contains referencesto trademarks and service marks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this prospectusmay appear without the ® or ™ symbols, but such references are not intended to indicate, in any way, that the applicable licensorwill not assert, to the fullest extent under applicable law, its rights to these trademarks and trade names. We do not intend our useor display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorshipof us by, any other companies.

SELECTEDDEFINITIONS

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

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

“Arena CommitmentShares” refer to up to 1,000,000 shares of Common Stock issued to Arena as consideration for executing and delivering the ArenaPurchase Agreement.

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

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

“Board”refers to the board of directors of CERo.

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

“Business CombinationAgreement” refers to the Business Combination Agreement, dated as of June 4, 2023, as amended by Amendment No. 1, dated February5, 2024 and Amendment No. 2, dated February 13, 2024, by and between PBAX, Merger Sub and Legacy CERo.

“Bylaws”refers to the Amended and Restated Bylaws of CERo.

“Charter”refers to CERo’s Second Amended and Restated Certificate of Incorporation, as filed with the Secretary of the State of DelawareFebruary 14, 2024.

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

“Closing”refers to the closing of the Business Combination.

“Commitment Shares”refers to the Arena Commitment Shares and the Keystone Commitment Shares.

“Committed EquityFinancings” refer to the Arena Equity Financing and the Keystone Equity Financing.

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

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

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

“Convertible BridgeNotes” refer to the senior secured convertible notes issued by Legacy CERo to certain Legacy CERo Stockholders, which automaticallyconverted into shares of Common Stock upon Closing.

“Danforth”refers to Danforth Advisors, LLC.

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

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

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

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

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

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

 “First PIPEFinancing” refers to the private placement pursuant to which we issued and sold, and the PIPE Investors purchased, shares ofSeries A Preferred Stock, the Series A Warrants and Preferred Warrants, on the terms and conditions set forth in the First SecuritiesPurchase Agreement.

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

“First SecuritiesPurchase Agreement” refers to the Amended and Restated Securities Purchase Agreement, dated as of February 14, 2024, by andamong PBAX, Legacy CERo and certain PIPE Investors, pursuant to which CERo agreed to issue and sell 10,039 shares of Series A PreferredStock, 612,746 Series A Warrants and 2,500 Preferred Warrants.

“Initial PublicOffering” refers to the initial public offering of PBAX, which closed on October 8, 2021.

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

“Keystone”refers to Keystone Capital Partners, LLC.

“Keystone CommencementDate” refers to the time when all of the conditions to our right to commence sales of Common Stock to Keystone set forth inthe respective Keystone Purchase Agreements have been satisfied.

“Keystone CommitmentAmount” refers to the $25,000,000 of shares of Common Stock that Keystone has committed to purchase pursuant to the KeystonePurchase Agreements.

“Keystone CommitmentShares” refers to the 1,983,345 shares of Common Stock that have been issued to Keystone as consideration for Keystone enteringinto the Keystone Purchase Agreements.

“Keystone EquityFinancing” refers to the equity line of credit established by the Keystone Purchase Agreements.

“Keystone PurchaseAgreements” refers to the Old Keystone Purchase Agreement and the New Keystone Purchase Agreement.

 “KeystonePurchase Shares” refers to the shares of Common Stock that CERo may elect to issue and sell to Keystone after the Keystone CommencementDate.

“Keystone RegistrationRights Agreements” refers to the Old Registration Rights Agreement and the New Registration Rights Agreement.

“Legacy CERo”refers to CERo Therapeutics, Inc.

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

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

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

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

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

“Nasdaq”refers to the Nasdaq Stock Market LLC.

“New Keystone RegistrationRights Agreement” refers to the Registration Rights Agreement, dated as of November 8, 2024, by and between CERo and Keystone.

“New Keystone PurchaseAgreement” refers to the Common Stock Purchase Agreement, dated as of November 8, 2024, by and between CERo and Keystone.

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

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

“PBAX” refersto Phoenix Biotech Acquisition Corp., a Delaware corporation.

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

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

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

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

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

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

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

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

“Primary EarnoutShares” refer to the 1,200,000 shares of Common Stock issued to the holders of Legacy CERo common stock and Legacy CERo preferredstock in connection with the Business Combination, 1,000,000 of which are subject to vesting upon the achievement of certain stock price-basedearnout targets and 200,000 of which are subject to vesting upon a change of control, respectively.

“Private PlacementWarrants” refer to the warrants sold in a private placement concurrently with the Initial Public Offering.

“Primary EarnoutShares” refer to the 1,200,000 shares of Common Stock issued to the holders of Legacy CERo common stock and Legacy CERo preferredstock in connection with the Business Combination, 1,000,000 of which are subject to vesting upon the achievement of certain stock price-basedearnout targets and 200,000 of which are subject to vesting upon a change of control, respectively.

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

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

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

“SEC”refers to the U.S. Securities and Exchange Commission.

“Secondary EarnoutShares” refer to the 875,000 shares of Common Stock issued to the holders of Legacy CERo common stock and Legacy CERo preferredstock in connection with the Business Combination, which became fully vested at Closing.

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

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

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

“Securities Act”refers to the Securities Act of 1933, as amended.

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

“Selling Securityholder”refers to Keystone.

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

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

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

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

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

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

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

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

“Tertiary EarnoutShares” refer to the 1,000,000 shares of Common Stock issued to the holders of Legacy CERo common stock and Legacy CERo preferredstock in connection with the Business Combination, which will be fully vested upon the achievement of certain regulatory milestone-basedearnout targets.

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

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

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

“Warrant CommonShares” refer to the shares of Common Stock underlying the Common Warrants.

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

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

CAUTIONARYNOTE REGARDING FORWARD-LOOKING STATEMENTS

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

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

We have based these forward-lookingstatements largely on our current expectations and projections about our business, the industry in which we operate and financial trendsthat we believe may affect our business, financial condition, results of operations and prospects, and these forward-looking statementsare not guarantees of future performance or development. These forward-looking statements speak only as of the date of this prospectusand are subject to a number of risks, uncertainties and assumptions described in “Risk Factors” and elsewhere in thisprospectus. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted orquantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflectedin our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in theforward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statementscontained herein 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 uponinformation available to us as of the date of this prospectus, and while we believe such information forms a reasonable basis for suchstatements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted anexhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, andyou are cautioned not to unduly rely upon these statements.

RISKFACTORS

Investing in our securitiesinvolves a high degree of risk. Before you decide to invest in our securities, you should consider carefully the risks described below,together with the other information contained in this prospectus, including our financial statements and the related notes appearing atthe end of this prospectus. We believe the risks described below are the risks that are material to us as of the date of this prospectus.If any of the following risks actually occur, our business, results of operations and financial condition would likely be materially andadversely 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 the Keystone Equity Financing

It is not possible to predict the actualnumber of shares of our Common Stock, if any, we will sell under the Keystone Purchase Agreements, or the actual gross proceeds resultingfrom those sales or the dilution to you from those sales. Further, we may not have access to the full amount available under the KeystonePurchase Agreements. 

Pursuant to the Keystone Purchase Agreements, Keystone shall purchasefrom us up to $25,000,000 of shares (the “Keystone Commitment Amount”). As ofthe date of this prospectus, we have issued and sold 23,377,921 shares of Common Stock for aggregate proceeds of $4,410,616 pursuant tothe Keystone Equity Financing.

The shares of our CommonStock that may be issued under the Keystone Purchase Agreements may be sold by us to Keystone at our discretion from time to time fromthe applicable Keystone Commencement Date until the earliest to occur of (i) the 36-month anniversary of the effective date of the applicableRegistration Statement (as defined below), (ii) the date on which Keystone has purchased the Keystone Commitment Amount pursuant to theKeystone Purchase Agreements, (iii) the date on which our Common Stock fails to be listed or quoted on Nasdaq or any successor EligibleMarket (as defined in the Keystone Purchase Agreements), and (iv) the date on which, pursuant to or within the meaning of any bankruptcylaw, a custodian is appointed for us or for all or substantially all of our property, or we make a general assignment for the benefitof our creditors (each, a “Termination Event”).

We generally have the rightto control the timing and amount of any sales of our Common Stock to Keystone under the Keystone Purchase Agreements. Sales of our CommonStock, if any, to Keystone under the Keystone Purchase Agreements will depend upon market conditions and other factors to be determinedby us. We may ultimately decide to sell to Keystone all, some or none of the Common Stock that may be available for us to sell to Keystonepursuant to the Keystone Purchase Agreements. Accordingly, we cannot guarantee that we will be able to sell all of the Keystone CommitmentAmount or how much in proceeds we may obtain under the Keystone Purchase Agreements. If we cannot sell securities under the Keystone EquityFinancing, we may be required to utilize more costly and time-consuming means of accessing the capital markets, which could have a materialadverse effect on our liquidity and cash position.

Because the purchase priceper share of Common Stock to be paid by Keystone for the Common Stock that we may elect to sell to Keystone under the Keystone PurchaseAgreements, if any, will fluctuate based on the market prices of our Common Stock at the time we make such election, it is not possiblefor us to predict, as of the date of this prospectus and prior to any such sales, the number of shares of Common Stock that we will sellto Keystone under the Keystone Purchase Agreements, the purchase price per share that Keystone will pay for shares of Common Stock purchasedfrom us under the Keystone Purchase Agreements, or the aggregate gross proceeds that we will receive from those purchases by Keystoneunder the Keystone Purchase Agreements.

We previously registered26,619,050 shares of our Common Stock on a registration statement on Form S-1 (File No. 333-278603), which was declared effective by theSEC on May 1, 2024, and remains in effect (the “Prior Registration Statement” and, together with the Current RegistrationStatement, the “Registration Statements”). Such shares consist of up to (i) 25,000,000 Keystone Purchase Shares that we mayelect, in our sole discretion, to issue and sell to Keystone, from time to time under the Keystone Purchase Agreements, (ii) 619,050 KeystoneCommitment Shares that have been issued to Keystone as consideration for its execution and delivery of the Keystone Purchase Agreementsand (iii) up to 1,000,000 Arena Commitment Shares to be issued to Arena as consideration for its execution and delivery of the Arena PurchaseAgreement. As of November 21, 2024, there were 150,312,572 shares of Common Stock outstanding. If all of the 210,000,000 shares of ourCommon Stock offered for resale by the Selling Securityholder under this prospectus were issued and outstanding as of November 21, 2024,such shares would represent approximately 58.3% of total number of shares of our fully-diluted Common Stock outstanding.

The actual number of sharesof our Common Stock issuable will vary depending on the then current market price of shares of our Common Stock sold to the Selling Securityholderin this offering and the number of shares of our Common Stock we ultimately elect to sell to the Selling Securityholder under the KeystonePurchase Agreements. If it becomes necessary for us to issue and sell to Keystone under the Keystone Purchase Agreements more than the210,000,000 shares of our Common Stock being registered for resale under the Registration Statements in order to receive aggregate grossproceeds equal to $25.0 million under the Keystone Purchase Agreements, we must file with the SEC one or more additional registrationstatements to register under the Securities Act the resale by Keystone of any such additional shares of our Common Stock we wish to sellfrom time to time under the Keystone Purchase Agreements, which the SEC must declare effective, in each case before we may elect to sellany additional shares of our Common Stock under the Purchase Agreements. In addition, Keystone is not obligated to buy any Common Stockunder the Keystone Purchase Agreements if such shares, when aggregated with all other Common Stock then beneficially owned by Keystoneand its affiliates (as calculated pursuant to Section 13(d) of the Securities Exchange Act, and Rule 13d-3 promulgated thereunder), wouldresult in Keystone beneficially owning Common Stock in excess of 4.99% of the then-outstanding shares of Common Stock. Our inability toaccess a portion or the full amount available under the Keystone Purchase Agreements, in the absence of any other financing sources, couldhave a material adverse effect on our business or results of operation.

Keystone will pay less than the then-prevailingmarket price for our Common Stock, which could cause the price of our Common Stock to decline.

The purchase price of ourCommon Stock to be sold to Keystone under the Keystone Purchase Agreements is derived from the market price of our Common Stock on Nasdaq.Shares to be sold to Keystone pursuant to the Keystone Purchase Agreements will be purchased at a discounted price.

For example, we may effectsales to Keystone pursuant to a Fixed Purchase Notice (as defined below) at a purchase price equalto the lesser of 90% of (i) the daily VWAP (as defined below) of the Common Stock for thefive trading days immediately preceding the applicable Fixed Purchase Date (as defined below) and (ii) the closing price of a share ofCommon Stock on the applicable Fixed Purchase Date during the full trading day on such applicable Purchase Date. See “TheCommitted Equity Financing” for more information.

As a result of this pricingstructure, Keystone may sell the shares they receive immediately after receipt of such shares, which could cause the price of our CommonStock to decrease.

Investors who buy shares of Common Stockfrom Keystone at different times will likely pay different prices.

Pursuant to the KeystonePurchase Agreements, we have discretion, to vary the timing, price and number of shares of Common Stock we sell to Keystone. If and whenwe elect to sell shares of Common Stock to Keystone pursuant to the Keystone Purchase Agreements, after Keystone has acquired such shares,Keystone may resell all, some or none of such shares at any time or from time to time in its sole discretion and at different prices.As a result, investors who purchase shares from Keystone in this offering at different times will likely pay different prices for thoseshares, and so may experience different levels of dilution and in some cases substantial dilution and different outcomes in their investmentresults. Investors may experience a decline in the value of the shares they purchase from Keystone in this offering as a result of futuresales made by us to Keystone at prices lower than the prices such investors paid for their shares in this offering. In addition, if wesell a substantial number of shares to Keystone under the Keystone Purchase Agreements, or if investors expect that we will do so, theactual sales of shares or the mere existence of our arrangements with Keystone may make it more difficult for us to sell equity or equity-related securitiesin the future at a time and at a price that we might otherwise wish to effect such sales.

We are engaged in multiple transactionsand offerings of our securities. Future resales and/or issuances of shares of Common Stock, including pursuant to this prospectus, orthe perception that such sales may occur, may cause the market price of our shares to drop significantly.

In February 2024 and October2024, we entered into the Keystone Purchase Agreements, pursuant to which Keystone shall purchase from us up to an aggregate of $25.0million of shares of Common Stock, upon the terms and subject to the conditions and limitations set forth in the Keystone Purchase Agreements.We have issued an aggregate of 1,983,345 Keystone Commitment Shares to Keystone as consideration for its execution and delivery of theKeystone Purchase Agreements.

The shares of our CommonStock that may be issued under the Keystone Purchase Agreements may be sold by us to Keystone at our discretion from time to time fromthe applicable Keystone Commencement Date until the earliest to occur of (i) the 36-month anniversary of the effective date of the applicableRegistration Statement, (ii) the date on which Keystone has purchased the Keystone Commitment Amount pursuant to the Keystone PurchaseAgreements, (iii) the date on which our Common Stock fails to be listed or quoted on Nasdaq or any successor Eligible Market (as definedin the Keystone Purchase Agreements), and (iv) the date on which, pursuant to or within the meaning of any bankruptcy law, a custodianis appointed for us or for all or substantially all of our property, or we make a general assignment for the benefit of our creditors.

The purchase price for sharesof our Common Stock that we may sell to Keystone under the Keystone Purchase Agreements will fluctuate based on the trading price of sharesof our Common Stock. Depending on market liquidity at the time, sales of shares of our Common Stock may cause the trading price of sharesof our Common Stock to decrease. We generally have the right to control the timing and amount of any future sales of shares of our CommonStock to Keystone. Additional sales of shares of our Common Stock, if any, to Keystone will depend upon market conditions and other factorsto be determined by us. We may ultimately decide to sell to Keystone all, some or none of the additional shares of our Common Stock thatmay be available for us to sell pursuant to the Keystone Purchase Agreements. If and when we do sell shares of our Common Stock to Keystone,after Keystone has acquired shares of our Common Stock, Keystone may resell all, some or none of such shares of our Common Stock at anytime or from time to time in its discretion and at different prices. Therefore, sales to Keystone by us could result in substantial dilutionto the interests of other holders of shares of our Common Stock. In addition, if we sell a substantial number of shares of our CommonStock to Keystone under the Keystone Purchase Agreements, or if investors expect that we will do so, the shares held by Keystone willrepresent a significant portion of our public float and may result in substantial decreases to the price of our Common Stock. The actualsales of shares of our Common Stock or the mere existence of our arrangement with Keystone may also make it more difficult for us to sellequity or equity-related securities in the future at a time and at a price that we might otherwise wish to effect such sales.

We may use proceeds from sales of our CommonStock made pursuant to the Keystone Purchase Agreements in ways with which you may not agree or in ways which may not yield a significantreturn.

We will have broad discretion over the use ofproceeds from sales of our Common Stock made pursuant to the Keystone Purchase Agreements, including for any of the purposes describedin the section entitled “Use of Proceeds,” and you will not have the opportunity, as part of your investment decision,to assess whether the proceeds are being used appropriately. Because of the number and variability of factors that will determine ouruse of the net proceeds, their ultimate use may vary substantially from their currently intended use. While we expect to use the netproceeds from this offering as set forth in “Use of Proceeds,” we are not obligated to do so. The failure by us toapply these funds effectively could harm our business, and the net proceeds may be used for corporate purposes that do not increase ouroperating results or enhance the value of our Common Stock.

Risks Related to this Offering by the SellingSecurityholder

The shares of Common Stock being offeredin this prospectus represent a substantial percentage of the outstanding shares of Common Stock, and the sales of such shares, or theperception that these sales could occur, could cause the market price of the Common Stock to decline significantly.

Under this prospectus, theSelling Securityholder can resell up to a total of 210,000,000 shares of Common Stock. The shares of Common Stock being offered for resalepursuant to this prospectus by the Selling Securityholder would represent approximately 58.3% of the shares of fully-diluted Common Stockoutstanding as of November 21, 2024, assuming and after giving effect to the issuance of Common Stock upon exercise of all outstandingPreferred Warrants and the maximum number of shares of Common Stock issuable upon conversion of all outstanding Preferred Shares. Giventhe substantial number of shares of Common Stock being registered pursuant to this prospectus, the sale of such shares, or the perceptionin the market of the potential for the sale of a large number of shares, could increase the volatility of the market price of the CommonStock or result in a significant decline in the public trading price of the Common Stock.

Sales of a substantial number of our securitiesin the public market by the Selling Securityholder and/or by our existing securityholders could cause the price of our Common Stock andWarrants to fall.

The securities being offeredin this prospectus represent a substantial percentage of our outstanding shares of Common Stock and Warrants. Under this prospectus, theSelling Securityholder can resell up to total of 210,000,000 shares of Common Stock.

Sales of a substantial numberof shares of our Common Stock in the public market, including the resale of the shares held by the Selling Securityholder, could occurat any time (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). These sales, or the perception in the market thatthe holders of a large number of shares of our Common Stock intend to sell shares, could increase the volatility of the market price ofour Common Stock or result in a significant decline in the public trading price of our Common Stock. The shares of Common Stock beingoffered for resale pursuant to this prospectus by the Selling Securityholder represent approximately 43.0% of shares of fully-dilutedCommon Stock outstanding as of November 21, 2024, assuming and after giving effect to the issuance of Common Stock upon exercise of alloutstanding Common Warrants and options and Preferred Warrants and the maximum number of shares of Common Stock issuable upon conversionof all outstanding Preferred Shares.

After the registration statementof which this prospectus forms a part is effective and until such time that it is no longer effective, it will permit the resale of theseshares of Common Stock. The resale, or expected or potential resale, of a substantial number of shares of our Common Stock in the publicmarket could adversely affect the market price for our Common Stock and make it more difficult for you to sell your holdings at timesand prices that you determine are appropriate. Furthermore, we expect that, because there is a large number of shares of our Common Stockbeing registered pursuant to the registration statement of which this prospectus forms a part, the Selling Securityholder thereunder willcontinue to offer 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 foran extended period of time. Sales of substantial number of such shares in the public market, including the resale of the shares of CommonStock held by the Selling Securityholder, could adversely affect the market price of our Common Stock.

In addition to this prospectus,we have filed:

In addition to any resalespursuant to such registration statements, subject to applicable transfer restrictions and the conditions to the availability of Rule 144for former shell companies under Rule 144(i), shares of Common Stock held by these stockholders will be eligible for resale, potentiallysubject to, in the case of stockholders who are our affiliates, volume, manner of sale, and other limitations under Rule 144 promulgatedunder the Securities Act.

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

The market price of sharesof our Common Stock could drop significantly if the holders of the shares of Common Stock described above sell them or are perceived bythe market as intending to sell them. These factors could also make it more difficult for us to raise additional funds through futureofferings of shares of our Common Stock or other securities.

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

Certain of our securityholders,including the Selling Securityholder, acquired our securities at prices below the current trading prices of our Common Stock and PublicWarrants and may experience a positive rate of return ranging from $0.00 to $0.078 based on the current trading prices. In particular,the effective purchase prices at which certain Legacy CERo Stockholders and the Sponsor acquired their shares of our Common Stock aregenerally substantially less than the Initial Public Offering price of $10.00 per share, after giving effect to the Exchange Ratio (asdefined in the Business Combination Agreement). Consequently, these securityholders may have an incentive to sell their shares of ourCommon Stock even if the trading price is below the price paid by investors in the Initial Public Offering, which could cause the marketprice of our Common Stock to decline. Such stockholders may realize a positive rate of return on the sale of their shares of Common Stockcovered by this prospectus even if the market price per share of our Common Stock is below $0.098 per share. On November 26, 2024,the closing prices of our Common Stock and our Public Warrants as reported on the Nasdaq were $0.1735 per share and $0.0198 perPublic Warrant, respectively. While the Selling Securityholder may experience a positive rate of return based on the current trading price,public securityholders may not experience a similar rate of return on the securities they purchased due to differences in the purchaseprices they paid and the trading price at the time of sale and may instead experience a negative rate of return on their investment.

Holders of our Warrants willbe less likely to exercise their Warrants if the exercise prices of their Warrants exceed the market price of our Common Stock. Thereis no guarantee that our Warrants will continue to be in the money prior to their expiration, and as such, the Warrants may expire worthless.As such, any cash proceeds that we may receive in relation to the exercise of the Warrants overlying shares of Common Stock being offeredfor sale in this prospectus will be dependent on the trading price of our Common Stock. There is no assurance that the holders of theWarrants will elect to exercise any or all of such Warrants. As of the date of this prospectus, (i) all of the Private Placement Warrantsand Public Warrants, which have an exercise price of $11.50 per share, (ii) all of the Rollover Warrants, which have an exercise priceof $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 ofthe money,” 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.

Risks Related to our Business and Industry

We have incurred significant losses in everyyear 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 stagebiopharmaceutical company with a limited operating history, and we have incurred significant net losses since our inception in 2016. Weincurred 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 accumulated deficit of $43.1 million. We have funded our operations to date primarily with proceedsfrom the sale of our equity securities in private financing transactions.

We have no products approvedfor commercial sale and we are devoting, and expect to continue devoting, substantially all of our financial resources and efforts toR&D of our only programmed CER-T cell product candidate, CER-1236, as well as to building out our manufacturing infrastructure, CDMOrelationships and CER-T cell programming technologies. Investment in biopharmaceutical product development, especially preclinical products,is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidatewill not successfully undergo or complete necessary clinical trials, fail to demonstrate adequate effect or an acceptable safety profile,gain regulatory approval and become commercially viable.

We expect that it could takeseveral years until any of our product candidates, which at present is solely CER-1236, receive regulatory and marketing approvaland are commercialized, and we may never be successful in obtaining regulatory and marketing approval and commercializing product candidates.We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. These net losses willadversely 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 increase substantially as we:

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

Because of the numerous risksand uncertainties associated with the development, manufacturing, delivery and commercialization of complex autologous cell therapies,we are unable to accurately predict the timing or amount of expenses or when, or if, we will be able to achieve profitability. If we arerequired by regulatory authorities to perform studies in addition to those currently expected, or if there are any delays in the initiationand completion of our clinical trials or the development of any of our product candidates, our expenses could increase and profitabilitycould be further delayed.

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

Our independent registered public accountantshave expressed substantial doubt as to our ability to continue as a going concern.

In its report on our financialstatements for the year ended December 31, 2023, our independent registered public accounting firm included an explanatory paragraph thatexpressed substantial doubt about our ability to continue as a going concern. Our current cash level raises substantial doubt about ourability to continue as a going concern. In addition, our future financial statements may include similar qualifications about our abilityto continue as a going concern. Our financial statements were prepared assuming that we will continue as a going concern and do not includeany adjustments that may result from the outcome of this uncertainty. If we are unable to meet our current operating costs, we will needto seek additional financing or modify or cease our operational plans. If we seek additional financing to fund our business activitiesin the future and there remains substantial doubt about our ability to continue as a going concern, investors or other financing sourcesmay be unwilling to provide additional funding to us on commercially reasonable terms or at all.

Our limited operating history makes it difficultto evaluate our business and assess our future viability and prospects.

We are a preclinical stagecompany with a limited operating history. We commenced operations in 2016, and our operations to date have been limited to organizingand planning our development efforts, raising capital, conducting discovery and research activities, filing patent applications, identifyingpotential product candidates, undertaking preclinical studies, and establishing arrangements with third parties for the manufacture ofinitial quantities of CER-1236 and component materials. We have not yet demonstrated our ability to successfully complete any clinicaltrials, obtain regulatory approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conductsales, marketing and distribution activities necessary for successful product commercialization. Consequently, any predictions you makeabout our future success or viability may not be as accurate as they could be if we had a longer operating history.

In addition, as a young business,we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We will need to transitionat some point from a company with a R&D focus to a company capable of supporting commercial activities. We may not be successful insuch a transition.

We expect our financial conditionand operating results to continue to fluctuate significantly from quarter to quarter and year to year due to a variety of factors, manyof which are beyond our control. Accordingly, you should not rely upon the results of any quarterly or annual periods as indications offuture operating performance.

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

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

All of our product candidates,including our lead product candidate, will require additional preclinical, clinical and non-clinical development, regulatory review andapproval in multiple jurisdictions, substantial investment, access to sufficient commercial manufacturing capacity and significant marketingefforts before we can generate any revenue from product sales. In addition, because our other product candidates are based on similartechnology as our lead product candidate, if the lead product candidate encounters additional safety issues, efficacy problems, manufacturingproblems, developmental delays, regulatory issues or other problems, our development plans and business would be significantly harmed.

We have not generated any revenue and maynever be profitable.

Our ability to become profitabledepends upon our ability to generate revenue. To date, we have not generated any revenue. We do not expect to generate significant revenueunless or until we successfully complete clinical development and obtain regulatory approval of, and then successfully commercialize,our product candidates. We do not know when, or if, we will generate any revenue. All of our product candidates, including CER-1236, arein the preclinical stages of development and will require additional preclinical studies, clinical development regulatory review and approval,substantial investment, access to sufficient commercial manufacturing capacity and significant marketing efforts before we can generateany revenue from product sales. Our ability to generate revenue depends on a number of factors, including, but not limited to, our abilityto:

Many of the factors listedabove are beyond our control and could cause us to experience significant delays or prevent us from obtaining regulatory approvals orcommercialize our product candidates. Even if we are able to commercialize our product candidates, we may not achieve profitability soonafter generating product sales, if ever. If we are unable to generate sufficient revenue through the sale of our product candidates orany future product candidates, we may be unable to continue operations without continued funding.

Our engineered CER-T cells represent a novelapproach to cancer treatment that creates significant challenges for us.

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

Our preclinical programs may experiencedelays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory approvals or to commercializethese programs on a timely basis or at all, which would have an adverse effect on our business.

Our product candidates, includingCER-1236, are in the preclinical development stage. The risk of failure of preclinical programs is high. Before we can commence clinicaltrials for a product candidate, we are nearing completion of extensive preclinical testing and studies to obtain regulatory clearanceto initiate human clinical trials with CER-1236, and have engaged in a pre-IND meeting with the FDA. We expect that our clinicaltrials will be conducted on populations based in the United States and Europe. We cannot be certain of the timely completion or outcomeof our preclinical testing and studies and cannot predict if the FDA, the EMA or other regulatory authorities will accept our proposedclinical programs or if the outcome of our preclinical testing and studies will ultimately support the further development of our programs.As a result, we cannot be sure that we will be able to submit INDs or similar applications for our clinical programs on the timelineswe expect, if at all.

Success in preclinical studies or clinicaltrials may not be indicative of results in future clinical trials.

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

Manufacturing genetically engineered productsis complex and we, or our third-party manufacturers, may encounter difficulties in production. If we or any of our third-party manufacturersencounter such 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 geneticallyengineered products is complex and may require the use of innovative technologies to handle living cells. Manufacturing these productsrequires facilities specifically designed for and validated for this purpose and sophisticated quality assurance and quality control proceduresare necessary. Slight deviations anywhere in the manufacturing process, including filling, labeling, packaging, storage and shipping andquality control and testing, may result in failures, product recalls or spoilage. When changes are made to the manufacturing process,we may be required to provide preclinical and clinical data showing the comparable identity, strength, quality, purity or potency of theproducts before and after such changes. If microbial, viral or other contaminations are discovered at manufacturing facilities, such facilitiesmay need to be closed for an extended period of time to investigate and remedy the contamination, which could delay clinical trials andadversely harm our business. The use of biologically derived ingredients can also lead to allegations of harm, including infections orallergic reactions, or closure of product facilities due to possible contamination.

In addition, there are risksassociated with large scale manufacturing for clinical trials or commercial scale including, among others, cost overruns, potential problemswith process scale-up, process reproducibility, stability issues, compliance with good manufacturing practices, lot consistency and timelyavailability of raw materials. Even if we obtain marketing approval for any of our product candidates, there is no assurance that we orour manufacturers will be able to manufacture the approved product to specifications acceptable to the FDA, the EMA or other comparableforeign regulatory authorities, to produce it in sufficient quantities to meet the requirements for the potential commercial launch ofthe product or to meet potential future demand. If we or our manufacturers are unable to produce sufficient quantities for clinical trialsor 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 createCER-T cells is a relatively new technology, and if we are unable to use this technology in our intended product candidates, our revenueopportunities will be materially limited.

Our technology involves arelatively new approach to T cell gene therapy. This technology may also not be shown to be effective in clinical studies that we mayconduct, or may be associated with safety issues that may negatively affect the development of our product candidates. For instance, lentiviralgene transduction may create unintended changes to the DNA such as a non-target site gene insertion, a large deletion, or a DNA translocation,any of which could lead to oncogenesis.

We may not be successful in our effortsto identify or discover additional product candidates.

The success of our businessdepends primarily upon our ability to identify, develop and commercialize products based on our CER-T cell technology. Our research programsmay fail to identify other potential product candidates outside of CER-1236 for clinical development for a number of reasons. We may beunsuccessful in identifying potential product candidates or our potential product candidates may be shown to have harmful side effectsor may have other characteristics that may make the products unmarketable or unlikely to receive marketing approval. Research programsto identify new product candidates require substantial technical, financial and human resources. We may focus our efforts and resourceson potential programs or product candidates that ultimately prove to be unsuccessful. If any of these events occur, we may be forced toabandon our research, development or commercialization efforts for a program or programs, which would have a material adverse effect onour business and could potentially cause us to cease operations.

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

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

If our product candidatesare approved but fail to achieve market acceptance among physicians, patients, hospitals, cancer treatment centers or others in the medicalcommunity, we will not be able to generate significant revenue. Even if our products achieve market acceptance, we may not be able tomaintain that market acceptance over time if new products or technologies are introduced that are more favorably received than our products,are more cost effective or render our products obsolete.

Data from our preclinical studies is limitedand may change as patient data become available or may not be validated in any future or advanced clinical trial.

Data from preclinical studiesand any clinical trials that we may complete is subject to the risk that one or more of the clinical outcomes may materially change aspatient enrollment continues and more patient data becomes available. For example, preclinical and Phase 1 results are preliminaryin nature and should not be viewed as predictive of ultimate success. It is possible that such results will not continue or may not berepeated in any clinical trial of our product candidates. For instance, our preclinical studies provide limited data and any clinicaltrials may not validate such results. Additionally, manufacturing can impact clinical outcomes and we have not yet completed manufacturingruns with a CDMO. We may also fail to develop and transfer to a CDMO any optimized manufacturing processes for any of our programs.Ultimately, if we cannot manufacture our product candidates with consistent and reproducible product characteristics, our ability to developand commercialize any product candidate would be significantly impacted.

Preliminary data also remainssubject to audit and verification procedures that may result in the final data being materially different from the preliminary data wepreviously published. As a result, initial, interim and preliminary data should be viewed with caution until the final data are available.Adverse differences between preliminary or interim data and final data could significantly harm our business prospects.

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

The IND for CER-1236 wasfiled on June 28, 2024 and on November 15, 2024, the FDA cleared us to begin clinical trials, but there are no assurances regarding theacceptance of any amendments or future INDs, which may impact the timelines we expect. For example, we may experience manufacturing delaysor other delays with future IND-enabling studies. Moreover, there can be no assurances that once trials begin, issues will not arise thatsuspend or terminate such clinical trials. Additionally, even if such regulatory authorities agree with the design and implementationof the clinical trials set forth in an IND, we cannot guarantee that such regulatory authorities will not change their requirements inthe future. These considerations also apply to new clinical trials we may submit as amendments to existing INDs.

Clinical trials are difficult to designand implement, involve uncertain outcomes and may not be successful.

Human clinical trials aredifficult to design and implement, in part because they are subject to rigorous regulatory requirements. The design of a clinical trialcan determine whether its results will support approval of a product, and flaws in the design of a clinical trial may not become apparentuntil the clinical trial is well advanced. We may be unable to design and execute a clinical trial that will be successful to achieveregulatory approval. There is a high failure rate for biological products proceeding through clinical trials, which may be higher forour product candidates because they are based on new technology and engineered on a patient-by-patient basis. Many companies in the pharmaceuticaland biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results inpreclinical testing and earlier-stage clinical trials. Data obtained from preclinical and clinical activities are subject to varying interpretations,which may delay, limit or prevent regulatory approval. In addition, we may experience regulatory delays or rejections as a result of manyfactors, including changes in regulatory policy during the period of our product candidate development. Any such delays could negativelyimpact our business, financial condition, results of operations and prospects.

We will depend on enrollment of patientsin our clinical trials for our product candidates. If we encounter difficulties enrolling patients in our clinical trials, our clinicaldevelopment activities could be delayed or otherwise adversely affected.

Identifying and qualifyingpatients to participate in clinical trials of our product candidates will be critical to our success. We may experience difficulties inpatient enrollment in our clinical trials for a variety of reasons. The timely completion of clinical trials in accordance with theirprotocols depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion.The enrollment of patients depends on many factors, including:

In particular, some of ourclinical trials will look to enroll patients with characteristics which are found in a very small population. For example, our clinicaltrial for CER-1236 will seek to enroll patients with hematologic malignancies, including AML, MCL, CLL, and other B cell and myeloidneoplasms. Other companies are conducting clinical trials with their engineered T cell therapies in hematologic malignancies and seekto enroll patients in their studies that may otherwise be eligible for our clinical trials, which could lead to slow recruitment and delaysin our clinical trials. In addition, since the number of qualified clinical investigators is limited, we expect to conduct some of ourclinical trials at the same clinical trial sites that some of our competitors use, which could further reduce the number of patients whoare available for our clinical trials in these clinical trial sites.

Moreover, because our productcandidates represent a departure from more commonly used methods for cancer treatment, potential study participants and their doctorsmay be inclined to use conventional therapies, such as chemotherapy and antibody therapy, rather than participate in our clinical trials.

Delays in patient enrollmentmay result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of theseclinical trials and adversely affect our ability to advance the development of our product candidates. In addition, many of the factorsthat may lead to a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approvalof our product candidates.

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

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

We currently have no marketing and salesorganization and have no experience in marketing products. If we are unable to establish marketing and sales capabilities or enter intoagreements with third parties 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 distribution capabilities and have no experience in marketing products. We intend to develop an in-house marketing organizationand sales force, which will require significant capital expenditures, management resources and time. We will have to compete with otherpharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel.

If we are unable or decidenot to establish internal sales, marketing and distribution capabilities, we will pursue collaborative arrangements regarding the salesand marketing of our product candidates following their approval. However, there can be no assurance that we will be able to establishor maintain such collaborative arrangements, or if we are able to do so, that they will have effective sales forces. Any revenue we receivewill depend upon the efforts of such third parties, which may not be successful. We may have little or no control over the marketing andsales efforts of such third parties and our revenue from product sales may be lower than if we had commercialized our product candidatesourselves. We also face competition in our search for third parties to assist us with the sales and marketing efforts of our product candidates.

There can be no assurancethat we will be able to develop in-house sales and distribution capabilities or establish or maintain relationships with third-party collaboratorsto commercialize any product in the United States or overseas.

We face competition from companies thathave developed or may develop product candidates for the treatment of the diseases that we may target, including companies developingnovel therapies and platform technologies. If these companies develop platform technologies or product candidates more rapidly than wedo, if their platform technologies or product candidates are more effective or have fewer side effects, our ability to develop and successfullycommercialize product candidates may be adversely affected.

The development and commercializationof cell and 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 havesignificantly greater financial, technical, manufacturing, marketing, sales and supply resources or experience than we do. If we successfullyobtain approval for any product candidate, we will face competition based on many different factors, including the safety and effectivenessof our product candidates, the ease with which our product candidates can be administered, the timing and scope of regulatory approvalsfor these product candidates, the availability and cost of manufacturing, marketing and sales capabilities, price, reimbursement coverageand patent position. Competing products and product candidates could present superior treatment alternatives, including by being moreeffective, safer, less expensive or marketed and sold more effectively than any products we may develop. Competitive products and productcandidates may make any product we develop obsolete or noncompetitive before we recover the expense of developing and commercializingsuch product. Such competitors could also recruit our employees, which could negatively impact our level of expertise and our abilityto execute our business plan.

These competitors also competewith us in recruiting and retaining qualified scientific and management personnel and establishing clinical study sites and patient registrationfor clinical studies, as well as in acquiring technologies complementary to, or necessary for, our programs. Smaller or early-stage companiesmay also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

Our commercial opportunitycould be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or lesssevere side effects, are more convenient or are less expensive or better reimbursed than any products that we may commercialize. Our competitorsalso may obtain FDA, EMA or other regulatory approval for their products more rapidly than we may obtain approval for ours, which couldresult in our competitors establishing a strong market position for either the product or a specific indication before we are able toenter the market.

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

Our ability to compete inthe highly competitive biotechnology and pharmaceutical industries depends upon our ability to attract and retain highly qualified managerial,scientific and medical personnel. We are highly dependent on the expertise of our management, scientific and medical personnel, includingour interim chief executive officer (“Chief Executive Officer”), Chris Ehrlich, our chief development officer (“ChiefDevelopment Officer”), Kristen Pierce, our chief financial officer (“Chief Financial Officer”), Al Kucharchuk and thehead of our scientific advisory board (the “Scientific Advisory Board”), Lawrence Corey. The loss of the services of any ofour executive officers, other key employees, and other scientific and medical advisors, and our inability to find suitable replacementscould result in delays in product development and harm our business.

We conduct substantiallyall of our operations at our facilities in the South San Francisco area. The San Francisco Bay Area region is headquarters to many otherbiopharmaceutical companies and many academic and research institutions. Competition for skilled personnel in our market is intense andmay limit our ability to hire and retain highly qualified personnel on acceptable terms or at all. Attrition may lead to higher costsfor hiring and retention, diversion of management time to address retention matters and disrupt the business.

To induce valuable employeesto remain at our company, in addition to salary and cash incentives, we have provided equity-based compensation for retention purposes.Despite our efforts to retain valuable employees, members of our management, scientific and development teams may terminate their employmentwith us on short notice. Although we have employment agreements with our key employees, these employment agreements provide for at-willemployment, which means that any of our employees could leave our employment at any time, with or without notice. We do not maintain “keyperson” insurance policies on the lives of these individuals or the lives of any of our other employees. Our success also dependson our ability to continue to attract, retain and motivate highly skilled junior, mid-level and senior managers as well as junior, mid-leveland senior scientific and medical personnel.

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

As our development, manufacturingand commercialization plans and strategies develop, we expect to add managerial, operational, sales, R&D, marketing, financial andother personnel. Current and future growth imposes and will impose significant added responsibilities on members of management, including:

Our future financial performanceand our ability to commercialize our product candidates will depend, in part, on our ability to effectively manage our growth, and ourmanagement may also have to divert a disproportionate amount of its attention away from day-to-day activities in order to devotea substantial amount of time to managing these growth activities.

We currently rely, and forthe foreseeable future will continue to rely, in substantial part on certain independent organizations, advisors and consultants. Therecan be no assurance that the services of independent organizations, advisors and consultants will continue to be available to us on atimely basis when needed, or that we can find qualified replacements. We may also be subject to penalties or other liabilities if we mis-classifyemployees as consultants. In addition, if we are unable to effectively manage our outsourced activities or if the quality or accuracyof the services provided by consultants is compromised for any reason, our clinical trials may be extended, delayed or terminated, andwe may not be able to obtain regulatory approval of our product candidates or otherwise advance our business. There can be no assurancethat we will be able to manage our existing consultants or find other competent outside contractors and consultants on economically reasonableterms, or at all.

If we are not able to effectivelyexpand our organization by hiring and retaining employees and expanding our groups of consultants and contractors, we may not be ableto successfully implement the 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 unnecessary costs.

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

We may form or seek strategicalliances, create joint ventures or collaborations or enter into licensing arrangements with third parties that we believe will complementor augment our development and commercialization efforts with respect to our product candidates and any future product candidates thatwe may develop. Any of these relationships may require us to incur non-recurring and other charges, increase our near and long-term expenditures,issue securities 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 ornew technologies or acquire businesses, we may not be able to realize the benefit of such transactions if we are unable to successfullyintegrate them with our existing operations and company culture. For instance, certain of our agreements may require significant R&Dthat may not result in the development and commercialization of product candidates. We cannot be certain that, following a strategic transactionor license, we will achieve the results, revenue or specific net income that justifies such transaction.

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

We expect to spend a substantialamount of capital in the development and manufacturing of our product candidates, and we will need substantial additional financing todo so. In particular, we will require substantial additional financing to enable commercial production of our product candidates and initiateand complete registrational trials for multiple products in multiple regions. Further, if approved, we will require significant additionalcapital in order to launch and 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 fasterthan we currently anticipate, and we may need to spend more money than currently expected because of circumstances beyond our control.We may also need to raise additional capital sooner than we currently anticipate if we choose to expand more rapidly than we presentlyplan. In any event, we will require additional capital for the further development and commercialization of our product candidates, includingfunding our internal manufacturing capabilities.

We cannot be certain thatadditional funding will be available on acceptable terms, or at all. We have no committed source of additional capital. If we are unableto raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinuethe development or commercialization of our product candidates or other R&D initiatives. We could be required to seek collaboratorsfor our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwisebe available or relinquish or license on unfavorable terms our rights to our product candidates in markets where we otherwise would seekto pursue development or commercialization ourselves.

Any of the above eventscould significantly harm our business, prospects, financial condition and results of operations and cause the price of our Common Stockto decline.

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

Until such time, if ever,as we can generate substantial revenue from the sale of our product candidates, we will need substantial additional financing to developour product candidates and implement our operating plans. To the extent that we raise additional capital through the sale of equity orconvertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or otherpreferences that could adversely affect your rights as a common stockholder. Debt financing and preferred equity financing, if available,may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additionaldebt, making capital expenditures or declaring dividends.

If we raise additional fundsthrough collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be requiredto relinquish valuable rights to our research programs or product candidates or grant licenses on terms that may not be favorable to usor that may be at less than the full potential value of such rights. If we are unable to raise additional funds through equity or debtfinancings or other arrangements with third parties when needed, we may be required to delay, limit, reduce or terminate our drug developmentor future commercialization efforts or grant rights to third parties to develop and market product candidates that we would otherwiseprefer to develop and market ourselves.

The issuance of shares of our Common Stockupon conversion or exercise of our outstanding Preferred Shares and Common Warrants and other securities that we may issue in future financingtransactions may result in substantial dilution to our stockholders.

As of the date of this prospectus,the Company currently has outstanding (i) 3,075 shares of Series A Preferred Stock with a conversion value of approximately $3.8 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; (ii) 486 shares of Series B Preferred Stock with a conversion value of approximately $0.6 million, convertible into sharesof Common Stock at a conversion rate of the stated value thereof divided by a current effective conversion price of $0.07416; (iii) 2,853shares of Series C Preferred Stock with a stated value of approximately $2.9 million, convertible into shares of Common Stock at a conversionrate of the stated value thereof divided by a conversion price of $0.022; (iv) 1,962 Preferred Warrants to purchase shares of Series APreferred Stock at 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 effectiveconversion price of $0.07416; (v) 612,746 Series A Warrants to purchase shares of Common Stock at an exercise price of $1.39 per share;(vi) 8,175,166 Series C Warrants to purchase shares of Common Stock at an exercise price of $0.098; and (vii) 9,879,858 Public Warrantsand Private Placement Warrants to purchase shares of Common Stock at exercise prices ranging from $9.20 to $11.50 per share. As of thedate of this prospectus, holders of 7,069 shares of Series A Preferred Stock, 140 shares of Series B Preferred Stock and 38 PreferredWarrants have converted such shares into an aggregate of approximately 110.9 million shares of Common Stock.

Although each of the conversionprice of the Preferred Shares and the exercise price of the Series A Preferred Warrants are at or above the trading price of our CommonStock as of the date of this prospectus, if such trading price increases, such conversion prices and exercise price will not change asa result thereof and could be below the trading price of our Common Stock as of the date of any future conversion or exercise thereof,resulting in dilution to our stockholders. In addition, the terms of the Series A Preferred Stock, the Series B Preferred Stock and theSeries C Preferred Stock contain certain penalties and adjustments to the amount included in determination of the conversion rate followingcertain breaches of the Company’s obligations thereunder, including, among other things, as a result of a failure to file or causethe SEC to declare one or more registration statements relating to the resale of the shares of Common Stock issuable upon conversion thereofby specified 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 thatwe will remain in compliance with all of the terms of the Series A Preferred Stock, Series B Preferred Stock or Series C Preferred Stockand that such penalties and adjustments will not apply in the future. In addition, we cannot assure you that we will not issue additionalconvertible or other derivative securities with highly dilutive penalty or adjustment provisions. As described elsewhere in this report,the Company needs to obtain financing to fund its research and development activities and, if the IND is accepted, clinical trials, aswell as other operations. Under challenging conditions in the equity capital markets, particularly for pre-commercialization biotech companies,we may have no viable alternatives to agreeing to inclusion of such provisions in the terms of future financings.

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

In the ordinary course ofour business, we may collect, 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 (includinghealth information), intellectual property, trade secrets, and proprietary business information owned or controlled by ourselves or otherparties. We may also share or receive sensitive information with our partners, CROs, CDMOs, or other third parties. Our ability to monitorthese third parties’ information security practices is limited, and these third parties may not have adequate information securitymeasures in place. If we (or a third party upon whom we rely) experience a security incident or are perceived to have experienced a securityincident, we may also experience adverse consequences.

Our internal computer systemsand those of our CROs, CDMOs, collaborators, contractors, consultants or other third parties are vulnerable to damage from computer viruses,unauthorized access, cybersecurity threats, and telecommunication and electrical failures. In addition, as many of our personnel workfrom home at least part of the time and utilize network connections outside our premises, this poses increased risks to our informationtechnology systems and data. Cyberattacks, malicious internet-based activity, and online and offline fraud are prevalent and are increasingin their frequency, sophistication and intensity, and have become increasingly difficult to detect. These threats come from a varietyof sources, including traditional computer “hackers,” “hacktivists,” organized criminal threat actors, threatactors, personnel (such as through theft or misuse), sophisticated nation-states, and nation-state-supported actors. Some actors now engageand are expected to continue to engage in cyber-attacks, including without limitation nation-state actors for geopolitical reasons andin conjunction with military conflicts and defense activities. During times of war and other major conflicts, we, and the third partiesupon which we rely, may be vulnerable to a heightened risk of these attacks, including retaliatory cyber-attacks, that could materiallydisrupt our systems and operations, supply chain, and ability to produce and distribute our product candidates. We and the third partiesupon which we rely are 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 credential stuffing), 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 or hardware failures, loss of data or other information technology assets, adware, telecommunications failures or other similarissues. In particular, ransomware attacks are becoming increasingly prevalent and severe and can lead to significant interruptions, delays,or outages in our operations, disruptions to our clinical trials, loss of data (including data related to clinical trials), significantexpense to restore data or systems, reputational loss and the diversion of funds. Extortion payments may alleviate the negative impactof a ransomware attack, but we may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibitingsuch payments. Similarly, supply chain attacks have increased in frequency and severity, and we cannot guarantee that third parties andinfrastructure in our supply chain have not been compromised or that they do not contain exploitable defects or bugs that could resultin a breach to our information technology systems or the third-party information technology systems that support us and our services.Future or past business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities,as our 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 identifiedor similar threats could 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 sensitiveinformation. A security incident or other interruption could disrupt our ability (and that of third parties upon whom we rely) to manufactureor deliver our product candidates.

We may expend significantresources, or modify our business activities and operations, including our clinical trial activities, in an effort to protect againstsecurity incidents. Certain data privacy and security obligations may require us to implement and maintain specific security measuresor use industry-standard or reasonable security measures to protect our information technology systems and sensitive information.

Although we have implementedsecurity measures designed to protect against security incidents, there can be no assurance that these measures will be effective. Wehave experienced attempts to compromise our information technology systems or otherwise cause a security incident, but, to our knowledge,such attempts have been unsuccessful. In addition, from time to time, our vendors inform us of security incidents. To date, our reviewof such incidents as reported to us did not reveal material information being lost, CERo-specific security vulnerabilities or provideany useful information or insight into our systems or environment. However, we may not have all information related to such incidentsand future incidents could have an adverse impact on our business.

We may be unable to detectvulnerabilities in our information technology systems because such threats and techniques change frequently, are often sophisticated innature, and may not be detected until after a security incident has occurred. Despite our efforts to identify and remediate exploitablecritical vulnerabilities, if any, in our information technology systems, our efforts may not be successful. Further, we may experiencedelays in developing and deploying remedial measures designed to address any such identified vulnerabilities. Any failure to prevent ormitigate security incidents or improper access to, use of, or disclosure of our clinical data or patients’ personal data could resultin significant liability under state, federal, and international law and may cause a material adverse impact to our reputation, affectour ability to conduct our clinical trials and potentially disrupt our business.

Applicable data protectionlaws, privacy policies and data protection obligations may require us to notify relevant stakeholders of security incidents. Such disclosuresare costly, and the disclosures or the failure to comply with such requirements could lead to adverse consequences. If we (or a thirdparty upon whom we rely) experience a security incident or are perceived to have experienced a security incident, we may also experienceadverse 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 personaldata); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund diversions;interruptions in our operations (including availability of data); financial loss; and other similar harms.

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

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

Disruptions at the FDA, the SEC and othergovernment agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadershipand other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise preventthose agencies from performing normal business functions on which the operation of our business may rely, which could negatively impactour business.

The ability of the FDA toreview and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hireand retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at theagency have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on whichour operations may rely, including those that fund R&D activities is subject to the political process, which is inherently fluid andunpredictable.

Disruptions at the FDA andother agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which wouldadversely affect our business. For example, over the last several years the U.S. government has shut down several times andcertain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stopcritical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely reviewand process our regulatory submissions, which could have a material adverse effect on our business. Further, in our operations as a publiccompany, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properlycapitalize and continue our operations.

Since March 2020, whenforeign and domestic inspections of facilities were largely placed on hold, the FDA has been working to resume pre-pandemic levels ofinspection activities, including routine surveillance, bioresearch monitoring and pre-approval inspections. Should the FDA determine thatan inspection is necessary for approval and an inspection cannot be completed during the review cycle due to restrictions on travel orotherwise, and the FDA does not determine a remote interactive evaluation to be adequate, the FDA has stated that it generally intendsto issue, depending on the circumstances, a complete response letter or defer action on the application until an inspection can be completed.

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

Our operations, and thoseof our CROs, CDMOs and other 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 orman-made disasters or business interruptions. The occurrence of any of these business disruptions could seriously harm our operationsand financial condition and increase our costs and expenses. Our ability to obtain clinical supplies of our product candidates could bedisrupted if the operations of these suppliers are affected by a man-made or natural disaster or other business interruption.

Our employees, independent contractors,consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatorystandards and requirements.

We are exposed to the riskof employee fraud or other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors. Misconductby these parties could include intentional, reckless and/or negligent conduct that fails to comply with the regulations of the FDA andother similar foreign regulatory authorities, provide true, complete and accurate information to the FDA and other similar foreign regulatoryauthorities, comply with manufacturing standards we have established, comply with healthcare fraud and abuse laws in the United Statesand similar foreign fraudulent misconduct laws or report financial information or data accurately or to disclose unauthorized activitiesto us. If we obtain FDA approval of any of our product candidates and begin commercializing those products in the United States, our potentialexposure under such laws and regulations will increase significantly, and our costs associated with compliance with such laws and regulationsare also likely to increase. These laws may impact, among other things, our current activities with principal investigators and researchpatients, as well as proposed and future sales, marketing and education programs. In particular, the promotion, sales and marketing ofhealthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designedto prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide rangeof pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other businessarrangements generally. For more information, see the section entitled “Business– Healthcare Laws and Regulations.”

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

The scope and enforcementof each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform, especially in light ofthe lack of applicable precedent and regulations. Ensuring business arrangements comply with applicable healthcare laws, as well as respondingto possible investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention fromother aspects of its business.

It is not always possibleto identify and deter employee misconduct, and our code of ethics and the other precautions we take to detect and prevent inappropriateconduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigationsor other actions or lawsuits stemming from a failure to be in compliance with such laws or regulations.

Efforts to ensure that ourbusiness arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. Becauseof the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of ourbusiness activities could be subject to challenge under one or more of such laws. It is possible that governmental authorities will concludethat our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuseor other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmentalregulations that may apply 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 governmentfunded healthcare programs, such as Medicare and Medicaid, additional reporting requirements and oversight if we become subject to a corporateintegrity agreement or similar agreement to resolve allegations of non-compliance with these laws, reputational harm, and we may be requiredto curtail or restructure our operations, any of which could adversely affect our ability to operate our business and our results of operations.

The shifting compliance environmentand the need to build and maintain robust and expandable systems to comply with multiple jurisdictions with different compliance and/orreporting requirements increases the possibility that a healthcare company may run afoul of one or more of the requirements. Any actionagainst us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expensesand divert our management’s attention from the operation of our business.

The provision of benefitsor advantages to physicians to induce or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinalproducts is also prohibited in the European Union. The provision of benefits or advantages to induce or reward improper performancegenerally is typically governed by the national anti-bribery laws of European Union Member States, and in respect of the U.K. (which islonger a member of the European Union), the U.K. Bribery Act 2010. Infringement of these laws could result in substantial finesand imprisonment. European Union Directive 2001/83/EC, which is the European Union Directive governing medicinal products for human use,further provides that, where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniaryadvantages or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practiceof medicine or pharmacy. This provision has been transposed into the Human Medicines Regulations 2012 and so remains applicable in theUK despite its departure from the European Union. Payments made to physicians in certain European Union Member States must be publiclydisclosed. Moreover, agreements with physicians often must be the subject of prior notification and approval by the physician’semployer, his or her competent professional organization and/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 UnionMember States. Failure to comply with these requirements could result in reputational risk, public reprimands, administrative penalties,fines or imprisonment.

The collection, use, disclosure,transfer, or other processing of personal data regarding individuals in the European Union, including personal health data, is subjectto the European Union General Data Protection Regulation (“GDPR”), which became effective on May 25, 2018, as well asthe United Kingdom’s General Data Protection Regulations (the “UK GDPR”), which, together with the amended UK Data ProtectionAct 2018, retains the GDPR in UK national law. The GDPR is wide-ranging in scope and imposes numerous requirements on companies thatprocess personal data, including requirements relating to processing health and other sensitive data, obtaining consent of the individualsto whom the personal data relates, providing information to individuals regarding data processing activities, implementing safeguardsto protect the security and confidentiality of personal data, providing notification of data breaches, and taking certain measures whenengaging third-party processors. The GDPR also imposes strict rules on the transfer of personal data to countries outside the EuropeanUnion, 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 million or 4% of annual global revenues, whichever is greater; UK GDPR mirrors such finesunder the GDPR. The GDPR also confers a private right of action on data subjects and consumer associations to lodge complaints withsupervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations of the GDPR. Compliancewith the GDPR will be a rigorous and time-intensive process that may increase our cost of doing business or require us to change our businesspractices, and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harmin connection with European activities. This and other future developments regarding the flow of data across borders could increase thecost and complexity of delivering our product candidates, if approved, in some markets and may lead to governmental enforcement actions,litigation, fines and penalties or adverse publicity, which could have an adverse effect on our reputation and business. 

Our product candidates may cause undesirableside effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercialpotential or result in significant negative consequences.

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

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

We may also combine the useof our product candidates with other investigational or approved therapies that may cause separate adverse events or events related tothe combination or potentiate side effects of approved drugs.

If unacceptable toxicitiesarise in the development of our product candidates, we could suspend or terminate our trials or the FDA, the EMA or comparable foreignregulatory authorities could order us to cease clinical trials or deny approval of our product candidates for any or all targeted indications.Any data safety monitoring board may also suspend or terminate a clinical trial at any time on various grounds, including a finding thatthe research patients are being exposed to an unacceptable health risk, including risks inferred from other unrelated immunotherapy trials.Treatment-related side effects could also affect patient recruitment or the ability of enrolled subjects to complete the trial or resultin potential product liability claims. In addition, these side effects may not be appropriately recognized or managed by the treatingmedical staff, as toxicities resulting from T cell therapy are not normally encountered in the general patient population and by medicalpersonnel. Inadequate training in recognizing or managing the potential side effects of our product candidates could result in patientdeaths. Any of these occurrences may harm our business, financial condition and prospects significantly.

Our product candidates may target healthycells expressing target antigens, leading to potentially fatal adverse effects.

Our product candidates targetspecific antigens that are also expressed on healthy cells. For example, cell surface phosphatidylserine, the target of CER-1236, hasbeen observed on activated immune cells, including platelets, and in rapidly dividing cells across various organs including the gastrointestinalsystem, hepatic system, cardiovascular system, renal system, pulmonary system, and the central nervous system and related peripheral nervoussystem. Our product candidates may target healthy cells, leading to serious and potentially fatal adverse effects. Even though we intendto closely monitor the side effects of our product candidates in both preclinical studies and clinical trials, we cannot guarantee thatproducts will not target and kill healthy cells.

Our product candidates may have seriousand potentially fatal cross-reactivity to lipids, peptides or protein sequences within the body.

Our product candidates mayrecognize and bind to a peptide unrelated to the target antigen to which it is designed to bind. If this peptide is expressed within normaltissues, our product 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-tumoror non-specific-reactivity may halt or delay any ongoing clinical trials for any CER-T cell based product candidate and prevent or delayregulatory approval. Unknown binding-reactivity of the CER-T cell binding domain to related proteins could also occur. Any non-specificbinding interactions that impacts patient safety could materially impact our ability to advance our product candidates into clinical trialsor to proceed to marketing approval and commercialization.

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

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

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

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

Our autologous cell therapyplatforms utilizes a relatively novel technology involving the genetic modification of cells, and no CER-T cell-based immunotherapy hasbeen approved to date. 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 reactionto cell-based immunotherapy in general, or negative clinical trial results from our cell-based therapy competitors, or auto-immune celltherapy candidates, could result in greater government regulation and stricter labeling requirements of cell-based immunotherapy products,including any of our product candidates, and could cause a decrease in the demand for any products we may develop. Adverse public attitudesmay adversely impact our ability to enroll patients in clinical trials. More restrictive government regulations or negative public opinioncould have an adverse effect on our business or financial condition and may delay or impair the development and commercialization of ourproduct candidates or demand for any products we may develop.

For example, in November2023, the FDA announced that it would be conducting an investigation into reports of T-cell malignancies following BCMA-directed or CD19-directedautologous CAR-T cell immunotherapies following reports of T cell lymphoma in patients receiving these therapies. In January 2024, theFDA determined that new safety information related to T cell malignancies should be included in the labeling with boxed warning languageon these malignancies for all BCMA- and CD-19-directed genetically modified autologous T cell immunotherapies. While CER-1236and our engineered CER-T cells are designed to utilize a different mechanism of action, FDA’s investigation into CAR-Ttherapies and other similar actions could result in increased government regulation, unfavorable public perception and publicity, potentialimpacts on enrollment in our clinical trials, potential regulatory delays in the testing or approval of our product candidates, stricterlabeling requirements for those product candidates that are approved, and a decrease in demand for any such product candidates.

Our product candidates for which we intendto seek approval as biological 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 biologicalproducts that are biosimilar to or interchangeable with an FDA-licensed reference biological product. Under the BPCIA, an applicationfor a biosimilar product may not be submitted to the FDA until four years following the date that the reference product was firstlicensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by the FDA until 12 years fromthe date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still marketa competing version of the reference product if the FDA approves a full BLA for the competing product containing the sponsor’s ownpreclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their product.

We believe that any of ourproduct candidates approved as a biological product under a BLA should qualify for the 12-year period of exclusivity. However, there isa risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our productcandidates to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated.Other aspects 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 totraditional generic substitution for non-biological products is not yet clear, and will depend on a number of marketplace and regulatoryfactors that are still developing.

If any approved productsare subject to biosimilar competition sooner than we expect, we will face significant pricing pressure and our commercial opportunitywill be limited.

The insurance coverage and reimbursementstatus of newly-approved products is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new products couldlimit our product revenues.

Our ability to commercializeany of our product candidates successfully will depend in part on the extent to which reimbursement for these products and related treatmentswill be available from government health administration authorities, private health insurers, and other organizations. In the United States,the principal decisions about reimbursement for new therapies are typically made by CMS, an agency within the United States Departmentof Health and Human Services. CMS decides whether and to what extent a new therapy will be covered and reimbursed under Medicare, andprivate payors tend to follow CMS determinations to a substantial degree. The availability and extent of reimbursement by governmentaland private payors is essential for most patients to be able to afford expensive treatments, such as cellular immunotherapy. There issignificant uncertainty related to the insurance coverage and reimbursement of newly approved products by government and third-party payors.In particular, there is no body of established practices and precedents for reimbursement of cellular immunotherapies, and it is difficultto predict what the regulatory authority or private payor will decide with respect to reimbursement levels for novel products such asours. Our product candidates may not qualify for coverage or direct reimbursement, or may be subject to limited reimbursement. If reimbursementor insurance coverage is not available, or is available only to limited levels, we may not be able to successfully commercialize our productcandidates, if approved. Even if coverage is provided, the approved reimbursement amount may not be sufficient to allow us to establishor maintain pricing to generate income.

In addition, reimbursementagencies in foreign jurisdictions may be more conservative than those in the United States. Accordingly, in markets outside the United States,the reimbursement 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 marketingapproval for a product candidate, our product candidates will remain subject to regulatory oversight.

Even if we receive marketingand regulatory approval for CER-1236 or any other product candidates, regulatory authorities may still impose significant restrictionson the indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies. CER-1236 and other productcandidates will also be 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, the authority to require labeling changes based on new safety information and to require post-market studies or clinicaltrials to evaluate serious safety risks related to the use of a biologic. Any regulatory approvals that we receive for CER-1236 or otherproduct candidates may also be subject to a REMS, limitations on the approved indicated uses for which the product may be marketed orto the conditions of approval, or contain requirements for potentially costly post-marketing testing, including post-approval clinicaltrials, and surveillance to monitor the quality, safety, and efficacy of the product, all of which could lead to lower sales volume andrevenue. For example, the holder of an approved BLA is obligated to monitor and report adverse events and any failure of a product tomeet the specifications in the BLA. The holder of an approved BLA also must submit new or supplemental applications and obtain FDAapproval for certain changes to the approved product, product labeling, or manufacturing process. Advertising and promotional materialsmust comply with FDA rules and are subject to FDA review, in addition to other potentially applicable federal and state laws.

In addition, product manufacturersand their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatoryauthorities for compliance with 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 severityor frequency, or problems with the facility where the product is manufactured or disagrees with the promotion, marketing or labeling ofthat product, a regulatory authority may impose restrictions relative to that product, the manufacturing facility or us, including requiringrecall or withdrawal of the product from the market or suspension of manufacturing.

If we or our contractorsfail to comply with applicable regulatory requirements following approval of CER-1236 or our other product candidates, a regulatory authoritymay:

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

Prior treatments can alter the cancer ortarget of CER-T cell therapy and negatively impact chances for achieving clinical activity with our programmed T cells.

Patients with hematologicalcancers receive highly toxic lympho-depleting chemotherapy as their initial treatment. These therapies can impact the viability of theT cells collected from the patient and can contribute to highly variable responses to programmed T cell therapies. Patients could alsohave received prior therapies that target the same target antigen on the cancer cells as our intended programmed T cell product candidateand thereby lead to a selection of cancer cells with low or no expression of the target. Cancers also naturally evolve and select cloneswith low or no expression of the target. As a result, our programmed T cell product candidates may not recognize the cancer cell and mayfail to achieve clinical activity. If any of our product candidates do not achieve a sufficient level of clinical activity, we may discontinuethe development of that product candidate, which could adversely affect our business, financial condition, results of operations, andprospects.

Risks Related to Reliance on Third-Parties

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

We expect to utilize anddepend upon independent investigators and collaborators, such as medical institutions, CROs, CDMOs and strategic partners to conduct ourpreclinical studies under agreements with us and in connection with our clinical trials. We expect to have to negotiate budgets and contractswith CROs, trial sites and CDMOs which may result in delays to our development timelines and increased costs. We will rely heavily onthese third parties over the course of our clinical trials and we control only certain aspects of their activities. As a result, we haveless direct control over the conduct, timing and completion of these clinical trials and the management of data developed through clinicaltrials than would be the case if we were relying entirely upon our own staff. Nevertheless, we are responsible for ensuring that eachof our studies is conducted in accordance with applicable protocol, legal and regulatory requirements and scientific standards and ourreliance on third parties does not relieve us of our regulatory responsibilities. We and these third parties are required to comply withGCPs, which are regulations and guidelines enforced by the FDA and comparable foreign regulatory authorities for product candidates inclinical development. Regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigatorsand trial sites. If we or any of these third parties fail to comply with applicable GCP regulations, the clinical data generated in ourclinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additionalclinical trials before approving our marketing applications. We cannot assure you that, upon inspection, such regulatory authorities willdetermine that any of our clinical trials comply with the GCP regulations. In addition, our clinical trials must be conducted with biologicalproduct produced under cGMP regulations, including current good tissue practice (“cGTP”) regulations, and will require a largenumber of test patients. Our failure or any failure by these third parties to comply with these regulations or to recruit a sufficientnumber of patients may require us to repeat clinical trials, which would delay the regulatory approval process. Moreover, our businessmay be implicated if any of these third parties violates federal or state fraud and abuse or false claims laws and regulations or healthcareprivacy and security laws.

Any third parties conductingour clinical trials are not and will not be our employees and, except for remedies available to us under our agreements with such thirdparties, we cannot control whether or not they devote sufficient time and resources to our product candidates. These third parties mayalso have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trialsor other drug development activities, which could affect their performance on our behalf. If these third parties do not successfully carryout their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of theclinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for otherreasons, our clinical trials may be extended, delayed or terminated and we may not be able to complete development of, obtain regulatoryapproval of or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects forour product candidates would be harmed, our costs could increase and our ability to generate revenue could be delayed.

Switching or adding thirdparties to conduct our clinical trials involves substantial cost and requires extensive management time and focus. In addition, changesin manufacturers often involve changes in manufacturing procedures and processes, which could require that we conduct bridging studiesbetween our prior clinical supply used in our clinical trials and that of any new manufacturer. We may be unsuccessful in demonstratingthe comparability of clinical supplies which could require the conduct of additional clinical trials. Additionally, there is a naturaltransition period when a new third party commences work. As a result, delays occur, which can materially impact our ability to meet ourdesired clinical development timelines.

We rely on third parties to manufactureand store our clinical product supplies, and we may have to rely on third parties to produce and process our product candidates, if approved.There can be no assurance that we will be able to establish or maintain relationships with such third parties. We may in the future establishour own manufacturing facility and infrastructure in addition to or in lieu of relying on third parties for the manufacture of our productcandidates, which would be costly, time-consuming and which may not be successful.

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

We have a long-term agreementin place with a CDMO for the manufacture of CER-1236. However, we have not yet caused our product candidates to be manufactured or processedon a commercial scale and may not be able to achieve manufacturing and processing and may be unable to create an inventory of mass-producedproduct to satisfy demands for any of our product candidates. Our clinical supply will also be limited to small quantities and any latentdefects discovered in our supply could significantly delay our development timelines.

In addition, our actual andpotential future reliance on a limited number of third-party manufacturers exposes us to the following risks:

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

In addition, we will relyon third parties to perform release tests on our product candidates prior to delivery to patients. If these tests are not appropriatelydone and test data are not reliable, patients could be put at risk of serious harm.

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

We are dependent on solesuppliers or a limited number of suppliers for certain components that are integral to our product candidates, including CER-1236. Ifthese or other suppliers encounter financial, operating or other difficulties or if our relationship with them changes, we may be unableto quickly establish or qualify replacement sources of supply and could face production interruptions, delays and inefficiencies. In addition,technology changes by our vendors could disrupt access to required manufacturing capacity or require expensive, time-consuming developmentefforts to adapt and integrate new equipment or processes. Our growth may exceed the capacity of one or more of these suppliers to producethe needed equipment and materials in sufficient quantities to support our growth. Any one of these factors could harm our business andgrowth prospects.

Our product candidates rely on the availabilityof specialty raw materials, which may not be available to us on acceptable terms or at all.

Our product candidates, includingCER-1236, require many specialty raw materials, some of which are manufactured by small companies with limited resources and experienceto support a commercial product. In addition, those suppliers normally support blood-based hospital businesses and generally do not havethe capacity to support commercial products manufactured under cGMP by biopharmaceutical firms. The suppliers may be ill-equipped to supportour needs, especially in non-routine circumstances like an FDA inspection or medical crisis, such as widespread contamination. We alsodo not have contracts with many of these suppliers and may not be able to contract with them on acceptable terms or at all. Accordingly,we may experience delays in receiving key raw materials to support clinical or commercial manufacturing.

In addition, some of ourraw materials are currently available from a single supplier, or a small number of suppliers. For example, the type of cell culture mediaand cryopreservation buffer that we currently use in our manufacturing process for the CER-T cells are available from multiple suppliers,but each version may perform differently, requiring us to characterize them and modify our protocols if we change suppliers. Disruptionof our cell manufacturing process may affect product health, fitness, and potentially anti-tumor activity and clinical responses. In addition,the cell processing equipment and tubing that we use in our current manufacturing process is only available from a single supplier. Wealso use certain biologic materials, including certain activating antibodies, that are available from multiple suppliers, but each versionmay perform differently, requiring us to characterize them and potentially modify some of our protocols if we change suppliers. We cannotbe sure that these suppliers will remain in business, or that they will not be purchased by one of our competitors or another companythat is not interested in continuing to produce these materials for our intended purpose. If we are required to change suppliers, thematerials may only be available from another supplier on terms that are less favorable to us than the terms under which we currently obtainthe materials. Accordingly, if we no longer have access to these suppliers, we may experience delays in our clinical or commercial manufacturingwhich could harm our business 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 involvethe controlled use of potentially hazardous substances, including chemical and biological materials. We and our suppliers are subjectto federal, state and local laws and regulations in the United States governing the use, manufacture, storage, handling and disposalof medical and hazardous materials. Although we believe that we and our suppliers’ procedures for using, handling, storing and disposingof these materials comply with legally prescribed standards, we and our suppliers cannot completely eliminate the risk of contaminationor injury resulting 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 applicableenvironmental laws and regulations is expensive, and current or future environmental regulations may impair our research, developmentand production efforts, which could harm our business, prospects, financial condition or results of operations.

Risks Related to Government and Regulation

Clinical development and the regulatoryapproval process involve a lengthy and expensive process with an uncertain outcome and results of earlier studies and preclinical data,and trials may not be predictive of future clinical trial results. If our preclinical studies and clinical trials are not sufficient tosupport regulatory approval of any of our product candidates, we may incur additional costs or experience delays in completing, or ultimatelybe 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 otherregulatory authorities in the United States and other countries, and such regulations differ from country to country. We are notpermitted to market our product candidates in the United States or in any foreign countries until they receive the requisite licensurefrom the applicable regulatory authorities of such jurisdictions. We have not previously submitted a BLA to the FDA or similar licensureapplications to comparable foreign regulatory authorities. A BLA must include extensive preclinical and clinical data and supporting informationto establish 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 thatour preclinical studies and clinical trial results will be sufficient to support regulatory approval of our product candidates. Clinicaltesting is expensive and can take many years to complete and its outcome is inherently uncertain. Human clinical trials are expensiveand difficult to design and implement, in part because they are subject to rigorous regulatory requirements. Failure or delay can occurat any time during the clinical trial process.

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

We may experience numerousadverse or unforeseen events during, or as a result of, preclinical studies and clinical trials that could delay or prevent our abilityto receive marketing approval or commercialize our product candidates, including:

If we are required to conductadditional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable tosuccessfully complete clinical trials of our product candidates or other testing, if the results of these trials or tests are not positiveor are only moderately positive or if there are safety concerns, our business and results of operations may be adversely affected andwe may incur significant additional costs. In addition, costs to treat patients with relapsed or refractory cancer and to treat potentialside effects that may result from our product candidates can be significant. Accordingly, our clinical trial costs are likely to be significantlyhigher than those for more conventional therapeutic technologies or drug product candidates.

We could also encounter delaysif a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such clinical trials are being conducted,by the Data Safety Monitoring Board for such clinical trial or by the FDA or other regulatory authorities. Such authorities may suspendor terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatoryrequirements or our clinical trial protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatoryauthorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate abenefit from the product candidates, changes in governmental regulations or administrative actions or lack of adequate funding to continuethe clinical trial. For example, in July 2024, we announced a clinical hold as a result of insufficient data provided with regard to twoissues within pharmacology and toxicology of CER-1236. In November 2024, we announced that the clinical hold was resolved and that theFDA had cleared our IND for Phase I clinical trials.

Any delay in obtaining, orinability to obtain, applicable regulatory approval would delay or prevent commercialization of our product candidates and would materiallyadversely impact our business and prospects and our ability to generate revenues from any of these product candidates will be delayedor not realized at all. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinicaltrials may also ultimately lead to the denial of regulatory approval of our product candidates. If one or more of our product candidatesgenerally prove to be ineffective, unsafe or commercially unviable, our CER-T cell platform would have little, if any, value, which wouldhave a material and adverse effect on our business, financial condition, results of operations and prospects.

Any of these factors, manyof which are beyond our control, may result in our failing to obtain regulatory approval to market any of our product candidates, or adelay in such approval, which would significantly harm our business, results of operations, and prospects. Of the large number of biologicalproducts in development, only a small percentage successfully complete the FDA or other regulatory approval processes and are commercialized.Even if we eventually complete clinical testing and receive licensure from the FDA or applicable foreign regulatory authorities for anyof our product candidates, the FDA or the applicable foreign regulatory may license our product candidates for a more limited indicationor a narrower patient population than we originally requested, and the FDA, or applicable foreign regulatory agency, may not license ourproduct candidates with the labeling that we believe is necessary or desirable for the successful commercialization of such product candidates.

Our manufacturing process needs to complywith FDA regulations relating to the quality and reliability of such processes. Any failure to comply with relevant regulations couldresult in delays in or termination of our clinical programs and suspension or withdrawal of any regulatory approvals.

In order to commerciallyproduce our products at a third party’s facility, we will need to comply with the FDA’s cGMP regulations and guidelines, includingcGTPs. We may encounter difficulties in achieving quality control and quality assurance and may experience shortages in qualified personnel.We are subject to inspections by the FDA and comparable foreign regulatory authorities to confirm compliance with applicable regulatoryrequirements. Any failure to follow cGMP, cGTP or other regulatory requirements or delay, interruption or other issues that arise in themanufacture, fill-finish, packaging, or storage of our CER-T cells as a result of a failure of the facilities or operations of third partiesto comply with regulatory requirements or pass any regulatory authority inspection could significantly impair our ability to develop andcommercialize our CER-T cell programs, including leading to significant delays in the availability of our CER-T cells for our clinicaltrials or the termination of or suspension of a clinical trial, or the delay or prevention of a filing or approval of marketing applicationsfor our CER-T cell product candidates. Significant non-compliance could also result in the imposition of sanctions, including warningor untitled letters, fines, injunctions, civil penalties, failure of regulatory authorities to grant marketing approvals for our CER-Tcell product candidates, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products, operatingrestrictions and criminal prosecutions, any of which could damage our reputation and our business.

Even if we receive regulatory approval forany of our product candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significantadditional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and marketwithdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems withour products.

If the FDA, EMA or any othercomparable regulatory authority 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 regulatoryrequirements. These requirements include submissions of safety and other post-marketing information and reports, registration requirements,applicable product tracking and tracing requirements and continued compliance with cGMPs, including cGTPs, and GCP, for any clinical trialsthat we conduct post-approval. Later discovery of previously unknown problems with a product, including adverse events of unanticipatedseverity or frequency, or with any future potential manufacturing facilities we may own, third-party manufacturers or manufacturing processes,or failure to comply with regulatory requirements, may result in, among other things:

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

Any government investigationof alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity.The occurrence of any event or penalty described above may inhibit our or our collaborators’ ability to commercialize our productcandidates, and harm our business, financial condition and results of operations.

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

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

Regulatory requirements in the United Statesand abroad governing cell therapy products have changed frequently and may continue to change in the future, which could negatively impactour ability to complete clinical trials and commercialize our product candidates in a timely manner, if at all.

Regulatory requirements inthe United States and abroad governing cell therapy products have changed frequently and may continue to change in the future. In2016, the FDA established the Office of Tissues and Advanced Therapies (“OTAT”) within its Center for Biologics Evaluationand Research to consolidate the review of gene therapy and related products, and has established the Cellular, Tissue and Gene TherapiesAdvisory Committee, among others, to advise this review. In September 2022, the FDA announced retitling of OTAT to the Office ofTherapeutic Products (“OTP”) and elevation of OTP to a “Super Office” to meet its growing cell and gene therapyworkload. In addition, under guidelines issued by the National Institute of Health (the “NIH”), gene therapy clinical trialsare also subject to review and oversight by an institutional biosafety committee (“IBC”), a local institutional committeethat reviews and oversees research utilizing recombinant or synthetic nucleic acid molecules at that institution. Before a clinical trialcan begin at any institution, that institution’s institutional review board, or IRB, and its IBC assesses the safety of the researchand identifies any potential risk to public health or the environment. While the NIH guidelines are not mandatory unless the researchin question is being conducted at or sponsored by institutions receiving NIH funding of recombinant or synthetic nucleic acid moleculeresearch, many companies and other institutions not otherwise subject to the NIH guidelines voluntarily follow them. Moreover, seriousadverse events or developments in clinical trials of gene therapy product candidates conducted by others may cause the FDA or other regulatorybodies to initiate a clinical hold on our clinical trials or otherwise change the requirements for approval of any of our product candidates.Although the FDA decides whether individual cell and gene therapy protocols may proceed, the review process and determinations of otherreviewing bodies can impede or delay the initiation of a clinical trial, even if the FDA has reviewed the trial and approved its initiation.

We may seek fast track and breakthroughtherapy designations or priority review for one or more of our product candidates, but we might not receive such designation or priorityreview, and even if we do, such designation or priority review may not lead to a faster development or regulatory review or approval process,and does not assure FDA approval of our product candidates. Even if a product qualifies for such designation or priority review, the FDAmay later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approvalwill not be shortened.

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

The FDA may issue a fasttrack designation to a product candidate if it is intended, whether alone or in combination with one or more other products, for the treatmentof a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a diseaseor condition. Fast track designation applies to the combination of the product and the specific indication for which it is being studied.The sponsor of a new biologic may request that the FDA designate the biologic as a fast track product at any time during the clinicaldevelopment of the product. For fast track products, sponsors may have greater interactions with the FDA during product development. Afast track product may also be eligible for rolling review, where the FDA may consider for review sections of the BLA on a rolling basisbefore the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the BLA, the FDAagrees to accept sections of the BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees uponsubmission of the first section of the BLA. However, the FDA’s goal for reviewing a BLA fast track application under the PDUFAdoes not begin until the last section of the application is submitted. Fast track designation may be withdrawn by the FDA if the FDA believesthat the designation is no longer supported by data emerging in the clinical trial process.

A breakthrough therapy isdefined as a product candidate that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threateningdisease or condition, and preliminary clinical evidence indicates that the product candidate may demonstrate substantial improvement overexisting therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.For product candidates that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsorof the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffectivecontrol regimens. Product candidates designated as breakthrough therapies by the FDA are also eligible for priority review if supportedby clinical data at the time of the submission of the BLA.

Fast track designation, priorityreview, and breakthrough therapy designation are within the discretion of the FDA. Accordingly, even if we believe that one of ourproduct candidates meets the criteria for any such designation, the FDA may disagree and instead determine not to make such designation.In any event, the receipt of such designation may expedite the development or approval process, but do not change the standards for approval.Even if a product qualifies for one or more of these programs, the FDA may later decide that the product no longer meets the conditionsfor qualification or 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 reviewor approval process and does not increase the likelihood that our product candidates will receive marketing approval.

A product may be eligiblefor accelerated approval if it is designed to treat a serious or life-threatening disease or condition and generally provides a meaningfuladvantage over available therapies upon a determination that the product candidate has an effect on a surrogate endpoint or intermediateclinical endpoint that is reasonably likely to predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversiblemorbidity or mortality, (“IMM”) that is reasonably likely to predict an effect on IMM or other clinical benefit. The FDA considersa clinical benefit to be a positive therapeutic effect that is clinically meaningful in the context of a given disease, such as IMM. Forthe purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physicalsign or 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 drugexclusivity for one or more of our product candidates, and even if we do, that exclusivity may not prevent the FDA from approving othercompeting products.

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

Obtaining orphan drug exclusivityfor our product candidates may be important to our commercial strategy. If a competitor obtains orphan drug exclusivity for and approvalof a product with the same indication as our product candidates before we do, and if the competitor’s product is the same drug ora similar medicinal product as ours, we could be excluded from the market. Even if we obtain orphan drug exclusivity after FDA approval,we may not be able to maintain it. For example, if a competitive product that is the same drug or a similar medicinal product as our productcandidate is shown to be clinically superior to our product candidate, any orphan drug exclusivity we have obtained will not block theapproval of such competitive product. In addition, orphan drug exclusivity will not prevent the approval of a product that is the samedrug as our product candidates if the FDA finds that we cannot assure the availability of sufficient quantities of the drug to meet theneeds of the persons with the disease or condition for which the drug was designated. If one or more of these events occur, it could havea material adverse effect on our company.

We are subject to stringent and changingprivacy laws, regulations and standards as well as policies, contracts and other obligations related to data privacy and security. Ouractual or perceived failure to comply with such obligations could lead to enforcement or litigation (that could result in fines or penalties),a disruption of clinical trials or commercialization of products, reputational harm, or other adverse business effects.

In the ordinary course ofbusiness, we will collect, receive, store, process, use, generate, transfer, disclose, make accessible, protect, secure, dispose of, transmitand share (collectively, processing) personal data and other sensitive information, including, but not limited to, proprietary and confidentialbusiness 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 obligationsthat apply to our processing of personal data and the processing of personal data on our behalf.

In the United States,federal, state, and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personaldata privacy laws, 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 CaliforniaConsumer Privacy Act (“CCPA”) applies to personal information of consumers, business representatives, and employees, and createsindividual privacy rights and places increased privacy and security obligations on entities handling personal data of consumers or households.The CCPA requires covered companies to provide disclosures to California consumers, affords California residents certain rights relatedto their personal data, including the right to opt-out of certain sales of personal data, and allow for a new cause of action for certaindata breaches. Although there are limited exemptions for clinical trial data under the CCPA, as our business progresses, the CCPA maybecome applicable and significantly impact our business activities and exemplifies the vulnerability of our business to evolving regulatoryenvironment related to personal data and protected health information. Furthermore, the California Privacy Rights Act of 2020,effective January 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 increasing number of laws, regulations and industry standards concerning privacy, data protection, information security andcross-border personal data transfers. For example, GDPR, UK GDPR, and China’s Personal Information Protection Law impose strictrequirements for processing personal data. Failure to comply with the requirements of the GDPR and the applicable national data protectionlaws of the European Union Member States may result in fines of up to €20,000,000 or up to 4% of the total worldwide annual turnoverof the preceding financial year, whichever is higher, other administrative penalties, and private litigation related to processing ofpersonal data brought by classes of data subjects or consumer protection organizations authorized at law to represent their interests.If we cannot implement a valid compliance mechanism for cross-border data transfers, we may face increased exposure to regulatory actions,substantial fines, and injunctions against processing or transferring personal data from Europe or other foreign jurisdictions. The inabilityto import personal data to the United States could significantly and negatively impact our business operations, including by limitingour ability to conduct clinical trial activities in Europe and elsewhere; limiting our ability to collaborate with parties that are subjectto such cross-border data transfer or localization laws; or requiring us to increase our personal data processing capabilities and infrastructurein foreign jurisdictions at significant expenses. European regulators have also ordered certain companies to suspend or permanently ceasecertain transfers out of Europe for allegedly violating the GDPR’s cross-border data transfer limitations.

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

Our obligations related todata privacy and security are quickly changing in an increasingly stringent fashion, creating some uncertainty as to the effective futurelegal framework. Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistentor conflict among jurisdictions. As a result, preparing for and complying with these obligations requires significant resources and maynecessitate changes to our information technologies, systems and practices, as well as those of any third-party collaborators, serviceproviders, contractors, consultants or other third parties that process personal data on our behalf.

Although we endeavor to complywith all applicable privacy 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 consultants fail to comply with such obligations, which could negatively impact our business operations and complianceposture. For example, any failure by a third-party service provider to comply with applicable law, regulations, or contractual obligationscould result in adverse effects, including inability to or interruption in our ability to operate our business and proceedings againstus by governmental entities or others. If we fail, or are perceived to have failed, to address or comply with obligations related to dataprivacy and security obligations, we could face significant consequences. These consequences may include, but are not limited to, governmentenforcement actions (e.g., investigations, fines, penalties, audits and inspections, and similar); litigation (including class-relatedclaims); additional reporting requirements and/or oversight; temporary or permanent bans on all or some processing of personal data; ordersto destroy or not use personal data; and imprisonment of company officials. Any of these events could have a material adverse effect onour reputation, business, or financial condition.

The impact of recent healthcare reform legislationand other changes in the healthcare industry and in healthcare spending on us is currently unknown, and may adversely affect our businessmodel.

Our revenue prospects couldbe affected by changes in healthcare spending and policy in the United States and abroad. We operate in a highly regulated industryand new laws, regulations or judicial decisions, or new interpretations of existing laws, regulations or decisions, related to healthcareavailability, the method of delivery or payment for healthcare products and services could negatively impact our business, operationsand financial condition.

There have been, and likelywill continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availabilityof healthcare and containing 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 ofthe government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs ofhealthcare and/or impose price controls may adversely affect:

Any reduction in reimbursementfrom Medicare or other government programs may result in a similar reduction in payments from private payors, which may adversely affectour future profitability.

Our business could be negatively impactedby environmental, social and corporate governance matters or our reporting of such matters.

Investors have increasedtheir emphasis on the environmental, social and governance (“ESG”) practices of companies across all industries, includingthe environmental impact of operations and human capital management. Expectations regarding voluntary ESG initiatives and disclosuresmay result in increased costs (including but not limited to increased costs related to compliance, stakeholder engagement, contractingand insurance), enhanced compliance or disclosure obligations, or other adverse impacts to our business, financial condition, or resultsof operations.

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

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

Our ability to utilize our net operatingloss carryforwards and certain other tax attributes may be limited.

Under current law, federalnet operating losses incurred in tax years beginning after December 31, 2017, may be carried forward indefinitely, but the deductibilityof such federal net operating losses is limited to 80% of taxable income. It is uncertain if and to what extent various states will conformto federal tax laws. Under Sections 382 and 383 of the Code, and corresponding provisions of state law, if a corporation undergoes an“ownership change” (generally defined as a greater than 50 percentage point change (by value) in the equity ownership of certainstockholders over a rolling three-year period), the corporation’s ability to use its pre-change net operating loss carryforwardsand other pre-change tax attributes to offset its post-change income or taxes may be limited. We have not yet completed a Section 382or Section 383 analysis, and therefore, there can be no assurances that any previously experienced ownership changes have not materiallylimited our utilization of affected net operating loss carryforwards or other tax attributes. We may experience ownership changes in thefuture, including in connection with the proposed Business Combination as a result of shifts in our stock ownership. We anticipate incurringsignificant additional net losses for the foreseeable future, and our ability to utilize net operating loss carryforwards associated withany such losses to offset future taxable income may be limited to the extent we incur future ownership changes. In addition, at the statelevel, 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 thatare applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or resultsof operations.

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

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

In order to market any productsoutside of the United States, we must establish and comply with numerous and varying regulatory requirements of other countries regardingsafety and 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 regulatoryapprovals could result in significant delays, difficulties and costs for us and may require additional preclinical studies or clinicaltrials which would be costly and time consuming. Regulatory requirements can vary widely from country to country and could delay or preventthe introduction of our products in those countries. Satisfying these and other regulatory requirements is costly, time consuming, uncertainand subject to unanticipated delays. In addition, our failure to obtain regulatory approval in any country may delay or have negativeeffects on the process for regulatory approval in other countries. We do not have any product candidates approved for sale in any jurisdiction,including international markets, and we do not have experience in obtaining regulatory approval in international markets. If we fail tocomply with regulatory requirements in international markets or to obtain and maintain required approvals, our ability to realize thefull market potential of our products will be harmed.

Our business operations and current andfuture relationships with healthcare professionals, principal investigators, consultants, customers and third-party payors in the United Statesand elsewhere may be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse, false claims, physician payment transparency,health information privacy and security and other healthcare laws and regulations, which could expose us to substantial penalties.

Healthcare providers, physiciansand third-party payors in the United States and elsewhere will play a primary role in the recommendation and prescription of anyproduct candidates for which we obtain marketing approval. Our current and future arrangements with healthcare professionals, principalinvestigators, consultants, customers and third-party payors may expose us to broadly applicable fraud and abuse and other healthcarelaws, including, without limitation, the U.S. federal Anti-Kickback Statute and the U.S. federal False Claims Act, that mayconstrain the business or financial arrangements and relationships through which we sell, market and distribute any product candidatesfor which we obtain marketing approval. In addition, we may be subject to physician payment transparency laws and patient privacy andsecurity regulation by the U.S. federal government and 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 ofthese laws and the narrowness of their exceptions and safe harbors, it is possible that our business activities can be subject to challengeunder one or more of such laws. The scope and enforcement of each of these laws is uncertain and subject to rapid change in the currentenvironment of healthcare reform. Federal and state enforcement bodies have continued their scrutiny of interactions between healthcarecompanies and healthcare providers, which has led to a number of significant investigations, prosecutions, convictions and settlementsin the healthcare industry.

Efforts to ensure that ourinternal operations and future business arrangements with third parties will comply with applicable healthcare laws and regulations willinvolve substantial costs. If our operations are found to be in violation of any of these laws or any other governmental regulations thatmay 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 healthcareprograms, contractual damages, reputational harm, diminished profits and future earnings, additional reporting or oversight obligationsif we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with the law and curtailmentor restructuring of our operations, any of which could adversely affect our ability to operate our business and pursue our strategy. Ifany of the physicians or other healthcare providers or entities with whom we expect to do business, including future collaborators, arefound not 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 laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverseeffect on the success of our business.

We are subject to numerousenvironmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage,treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, includingchemicals and biological and radioactive materials. Our operations also produce hazardous waste products. We generally contract with thirdparties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials.In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages,and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties.

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

We may be affected by regulatory responsesto climate-related issues.

The Biden administrationhas made climate change and the limitation of greenhouse gas (“GHG”) emissions one of its primary objectives. Several statesand other geographic regions in the United States have also adopted legislation and regulations to reduce emissions of GHGs.

On March 6, 2024, the SECfinalized new rules for public companies that will require extensive climate-related disclosures and significant analysis of the impactof climate-related issues on our business strategy, results of operations, and financial condition (the “SEC Climate DisclosureRules”). The new rules will require us to disclose our material climate-related risks and opportunities, GHG emissions inventory,climate-related targets and 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 andattention. We may also be exposed to legal or regulatory action or claims as a result of these new regulations. All of these risks couldhave a material adverse effect on our business, financial position, and/or stock price.

Risks Related to Intellectual Property

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

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

As such, we may not be successfulin preventing third parties from infringing, copying or misappropriating our intellectual property. There can also be no assurance thatpending patent applications owned by us will result in patents being issued to us, that patents issued to or licensed by us in the pastor in the future will not be challenged or circumvented by competitors or that such patents will be found to be valid or sufficientlybroad to protect our products or to provide us with any competitive advantage. Third parties could also obtain patents that may requireus to negotiate to obtain licenses to conduct our business, and any required licenses may not be available on reasonable terms or at all.We also rely on confidentiality and non-compete agreements with certain employees, independent distributors, consultants and other partiesto protect, in part, trade secrets and other proprietary rights. There can be no assurance that these agreements will not be breached,that we will have adequate remedies for any breach, that others will not independently develop substantially equivalent proprietary informationor that third parties will not otherwise gain access to our trade secrets or proprietary knowledge.

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

Our commercial success willdepend in part on us obtaining and maintaining patent protection and trade secret protection of our current and future product candidates,as well as successfully defending these patents against third-party challenges. Our ability to stop third parties from making, using,selling, offering to sell or importing our product candidates is dependent upon the extent to which we have rights under valid and enforceablepatents or trade secrets that cover these activities and the right under our licensed patents to contest alleged infringement.

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

Others have filed, and inthe future are likely to file, patent applications covering products and technologies that are similar, identical or competitive to oursor important to our business. We cannot be certain that any patent application owned by a third party will not have priority over patentapplications filed or in-licensed by us, or that we will not be involved in interference, opposition or invalidity proceedings beforeU.S. or non-U.S. patent offices.

The degree of future protectionfor our proprietary rights is uncertain because legal means afford only limited protection and may not adequately protect our rights orpermit us to gain or keep our competitive advantage. For example:

Should any of these eventsoccur, they could significantly harm our business, results of operations and prospects.

Without patent protectionon the composition of matter of our product candidates, our ability to assert our patents to stop others from using or selling our productcandidates in a non-pharmaceutically acceptable formulation may be limited.

Due to the patent laws ofa country, or the decisions of a patent examiner in a country, or our own filing strategies, we may not obtain patent coverage for allof our product candidates or methods involving these candidates in parent patent applications. We may have to pursue divisional patentapplications or continuation patent applications in the United States and other countries to obtain claim coverage for inventionswhich were disclosed but not claimed in parent patent applications.

Moreover, it is possiblethat our pending patent applications will not result in granted patents, and even if such pending patent applications are granted as patents,they may not provide a basis for intellectual property protection of commercially viable products nor provide us with any competitiveadvantages. Further, it is possible that, for any of the patents that may be granted in the future, others will design around the patentrights or identify cancer treatment methods that do not concern the rights covered by our patent rights or licenses. Further, we cannotassure investors that other parties will not challenge any patents granted to us or that courts or regulatory agencies will hold our patentsto be valid or enforceable. We also cannot guarantee that we will be successful in defending challenges made against our patents. Anysuccessful third-party challenge to our patents could result in the unenforceability or invalidity of such patents, or to such patentsbeing interpreted narrowly or otherwise in a manner adverse to our interests. Our ability to establish or maintain a technological orcompetitive advantage over our competitors may be diminished because of these uncertainties.

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

If we are unable to obtain and maintainpatent protection for any products we develop and for our technology, or if the scope of the patent protection obtained is not sufficientlybroad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to commercializeany product candidates we may develop and our technology may be adversely affected.

Our success depends in largepart on our ability to obtain and maintain patent protection in the United States and other countries with respect to our productcandidates, their respective components, formulations, combination therapies, methods used to manufacture them and methods of treatmentand development that are important to our business. If we do not adequately protect our intellectual property rights, competitors maybe able to erode or negate any competitive advantage we may have, which could harm our business and ability to achieve profitability.To protect our proprietary position, we file patent applications in the United States and abroad related to our product candidatesthat are important to our business; we may in the future also license or purchase patent applications filed by others. If we are unableto secure or maintain patent protection with respect to our technology and any proprietary products and technology we develop, our business,financial condition, results of operations and prospects could be materially harmed.

We cannot provide any assurancesthat any of our current or future patents have or will include claims with a scope sufficient to protect our current and future productcandidates or otherwise provide any competitive advantage. In addition, the laws of foreign countries may not protect our rights to thesame extent as the laws of the United States. Furthermore, patents have a limited lifespan. In the United States, the naturalexpiration of a patent is generally 20 years after its earliest U.S. non-provisional filing date. Various extensions may beavailable; however, the life of a patent, and the protection it affords, is limited. Given the amount of time required for the development,testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after suchcandidates are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others fromcommercializing products similar or identical to ours. Moreover, some of our patents and patent applications are, and may in the futurebe, owned by or co-owned with third parties. Any of the foregoing could have a material adverse effect on our competitive position, business,financial conditions, results of operations and prospects.

The patent prosecution processis complex, expensive, time-consuming and inconsistent across jurisdictions. We may not be able to file, prosecute, maintain, enforce,or license all necessary or desirable patent rights at a commercially reasonable cost or in a timely manner. In addition, we may not pursueor obtain patent protection in all relevant markets. It is possible that we will fail to identify important patentable aspects of ourR&D efforts in time to obtain any patent protection. While we enter into non-disclosure and confidentiality agreements with partieswho have access to confidential or patentable aspects of our R&D efforts, including for example, our employees, former employees,corporate collaborators, external academic scientific collaborators, CROs, contract manufacturers, consultants, advisors and other thirdparties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby endangeringour ability to seek patent protection. In addition, publications of discoveries in the scientific and scholarly literature often lag behindthe actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 monthsafter filing, or in some cases not at all. Consequently, we cannot be certain that we were the first to file for patent protection onthe inventions claimed in our patents or pending patent applications.

The issuance or grant ofa patent is not irrefutable as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courtsor patent offices in the United States and abroad. There may be prior art of which we are not aware that may affect the validityor enforceability of a patent claim. There also may be prior art of which we are aware, but which we do not believe affects the validityor enforceability of a claim, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim. We mayin the future, become subject to a third-party pre-issuance submission of prior art or opposition, derivation, revocation, re-examination,post-grant or inter partes review, or interference proceedings or other similar proceedings challenging our patent rights or thepatent rights of others in the USPTO or other foreign patent office. An unfavorable determination in any such submission, proceeding orlitigation could reduce the scope of or invalidate our patent rights, allow third parties to commercialize our technology or productsand compete directly with us, without payment to us, or extinguish our ability to manufacture or commercialize products without infringingthird-party patent rights.

Third-party claims of intellectual propertyinfringement may prevent or delay our product discovery and development efforts, and could increase our costs.

Our commercial success dependsin part on our avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigationinvolving patents and other intellectual property rights in the biotechnology and pharmaceutical industries, as well as administrativeproceedings for challenging patents, including interference, reexamination, and post grant review proceedings before the USPTO or oppositionsand other comparable proceedings in foreign jurisdictions. We may be exposed to, or threatened with, future litigation by third partieshaving patent or other intellectual property rights alleging that our product candidates and/or proprietary technologies infringe theirintellectual property rights. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by thirdparties, exist in the fields in which we are developing our product candidates. As the biotechnology and pharmaceutical industries expandand more patents are issued, the risk increases that our product candidates may give rise to claims of infringement of the patent rightsof others. Moreover, it is not always clear to industry participants, including us, which patents cover various types of drugs, productsor their methods of use or manufacture. Thus, because of the large number of patents issued and patent applications filed in our fields,there may be a risk that third parties allege they have patent rights encompassing our product candidates, technologies or methods.

Third parties may assertthat we are employing their proprietary technology without authorization. Generally, conducting preclinical and clinical trials and otherdevelopment activities in the United States is not considered an act of infringement. If CER-1236 or another product candidate iscleared/approved by the FDA, a third party may then seek to enforce its patent by filing a patent infringement lawsuit against us. Whilewe do not believe that any patent claims that could have a materially adverse effect on the commercialization of our product candidatesare valid and enforceable, we may be incorrect in this belief, or we may not be able to prove it in litigation. In this regard, patentsissued in the United States by law enjoy a presumption of validity that can be rebutted only with evidence that is “clear andconvincing,” a heightened standard of proof. There may be issued third-party patents of which we are currently unaware with claimsto compositions, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates.Patent applications can take many years to issue. There may be currently pending patent applications which may later result in issuedpatents that our product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of ourtechnologies infringes upon these patents. Moreover, we may fail to identify relevant patents or incorrectly conclude that a patent isinvalid, not enforceable, exhausted, or not infringed by our activities. If any third-party patents were held by a court of competentjurisdiction to cover the manufacturing process of our product candidates, constructs or molecules used in or formed during the manufacturingprocess, or any final product itself, the holders of any such patents may be able to block our ability to commercialize the product candidateunless we were to obtain a license under the applicable patents, or until such patents expire or they are finally determined to be heldinvalid or unenforceable. Similarly, if any third-party patent were held by a court of competent jurisdiction to cover aspects of ourformulations, processes for manufacture or methods of use, the holders of any such patent may be able to block our ability to developand commercialize the product candidate unless we were to obtain a license or until such patent expires or is finally determined to beheld invalid or unenforceable. In either case, such a license may not be available on commercially reasonable terms or at all. If we areunable to obtain a necessary license to a third-party patent on commercially reasonable terms, or at all, our ability to commercializeour product candidates may be impaired or delayed, which could in turn significantly harm our business. Even if we obtain a license, itmay be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In addition, if the breadth or strengthof protection provided by our patents is threatened, it could dissuade companies from collaborating with us to license, develop or commercializecurrent or future product candidates.

Parties making claims againstus may seek and obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercializeour product candidates. Defense of these claims, regardless of their merit, could involve substantial litigation expense and would bea substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we mayhave to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licensesfrom third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetaryexpenditure. We cannot predict whether any such license would be available at all or whether it would be available on commercially reasonableterms. Furthermore, even in the absence of litigation, we may need or may choose to obtain licenses from third parties to advance ourresearch or allow commercialization of our product candidates. We may fail to obtain any of these licenses at a reasonable cost or onreasonable terms, if at all. In that event, we would be unable to further develop and commercialize our product candidates, which couldharm our business significantly.

We could be found liablefor monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent of a thirdparty. A finding of infringement could prevent us from commercializing our product candidates or any future product candidates or forceus to cease some of our business operations, which could materially harm our business.

Although we have reviewedcertain third-party patents and patent filings that we believe may be relevant to our therapeutic candidates or products, we have notconducted a freedom-to-operate search or analysis for any of our therapeutic candidates or products, and we may not be aware of patentsor pending or future patent applications that, if issued, would block us from commercializing our therapeutic candidates or products.Thus, we cannot guarantee that our therapeutic candidates or products, or our commercialization thereof, do not and will not infringeany third party’s intellectual property.

We may not be successful in obtaining ormaintaining necessary rights to product components and processes for our manufacturing and development pipeline through acquisitions andin-licenses.

Presently, we have rightsto certain intellectual property, 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 Number17/400,082 was allowed and later issued on May 23, 2023 as U.S. Patent Number 11,655,282. This patent provides coverage over ourCER-1236 product candidate and includes claims directed to a CER comprising, at least in part, Tim-4, a phosphatidylserine binding domain,its sequence, and various Tim-4 proteins. Because additional product candidates may require the use of proprietary rights held by thirdparties, the growth of our business will likely depend in part on our ability to acquire, in-license or use these proprietary rights.In addition, while we have patent rights directed to certain T cell constructs, we may not be able to obtain intellectual property rightsto broader T cell or engineered T cell constructs.

Our product candidates mayalso require specific formulations to work effectively and efficiently and these rights may be held by others. Similarly, efficient productionor delivery of our product candidates may also require specific compositions or methods, and the rights to these may be owned by thirdparties. We may be unable to acquire or in-license any compositions, methods of use, processes or other third-party intellectual propertyrights from third parties that we identify as necessary or important to our business operations. We may fail to obtain any of these licensesat a reasonable cost or on reasonable terms, if at all, which would harm our business. We may need to cease use of the compositions ormethods covered 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 collaboratewith academic institutions to accelerate our preclinical research or development under written agreements with these institutions. Incertain cases, these institutions may provide us with an option to negotiate a license to any of the institution’s rights in technologyresulting from the collaboration. Regardless of such option, we may be unable to negotiate a license within the specified timeframe orunder terms that are acceptable to us. If we are unable to do so, the institution may offer the intellectual property rights to others,potentially blocking our ability to pursue our program. If we are unable to successfully obtain rights to required third-party intellectualproperty or to maintain the existing intellectual property rights we have, we may have to abandon development of such program and ourbusiness and financial condition could suffer.

The licensing and acquisitionof third-party intellectual property rights is a competitive area, and companies which may be more established, or have greater resourcesthan we do, may also be pursuing strategies to license or acquire third-party intellectual property rights that we may consider necessaryor attractive in order to commercialize our product candidates. More established companies may have a competitive advantage over us dueto their size, cash resources and greater clinical development and commercialization capabilities.

We may be involved in lawsuits to protector enforce our patents which could be expensive, time-consuming and unsuccessful.

Competitors may infringeour patents. To counter infringement 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 refuseto stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. Anadverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated, held unenforceableor interpreted narrowly and could put one or more of our pending patent applications at risk of not issuing. Defense of these claims,regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources fromour business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including trebledamages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesignour infringing products, which may be impossible or require substantial time and monetary expenditure.

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

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

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

Periodic maintenance andannuity fees on any issued patent are due to be paid to the USPTO and patent agencies outside the United States in several stagesover the lifetime of the patent. The USPTO and various foreign governmental patent agencies require compliance with a number of procedural,documentary, fee payment and other similar provisions during the patent application process. While an inadvertent lapse can in many casesbe cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliancecan result in abandonment or lapse of the patent, resulting in partial or complete loss of patent rights in the relevant jurisdiction.Non-compliance events that could result in abandonment or lapse of a patent include failure to respond to official actions within prescribedtime limits, non-payment of fees and failure to properly legalize and submit formal documents. If we fail to maintain the patents coveringour product candidates, our competitors might be able to enter the market, which would harm our business. In addition, to the extent thatwe have responsibility for taking any action related to the prosecution or maintenance of patents or patent application in-licensed froma third party, any failure on our part to maintain the in-licensed rights could jeopardize our rights under the relevant license and mayexpose us to liability.

We may be subject to claims challengingthe inventorship of our patents and other intellectual property.

We may in the future be subjectto claims that former employees, collaborators, or other third parties have an interest in our patents or other intellectual propertyas an inventor or co-inventor. For example, we may have inventorship disputes arise from conflicting obligations of consultants or otherswho are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenginginventorship. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual propertyrights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverseeffect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and bea distraction to management and other employees.

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

A third party may hold intellectualproperty rights, including patent rights, that are important or necessary to the development or manufacture of our product candidates.It may be necessary for us to use the patented or proprietary technology of third parties to commercialize our product candidates, inwhich case we would be required to obtain a license from these third parties. Such a license may not be available on commercially reasonableterms, or at all, and we could be forced to accept unfavorable contractual terms. If we are unable to obtain such licenses on commerciallyreasonable terms, our business could be harmed.

Issued patents covering our product candidatescould be found unpatentable, invalid or unenforceable if challenged in court or the USPTO.

If we initiate legal proceedingsagainst a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent coveringour product candidate, as applicable, is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaimsalleging invalidity and/or unenforceability are commonplace, and there are numerous grounds upon which a third party can assert invalidityor unenforceability of a patent. Third parties may also raise similar claims before administrative bodies in the United States orabroad, even outside the context of litigation. Such mechanisms include inter partes review, ex parte re-examination andpost grant review in the United States, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings).Such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover and protect our productcandidates. The outcome following legal assertions of unpatentability, invalidity and unenforceability is unpredictable. With respectto the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we, our patent counsel andthe patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of unpatentability, invalidityand/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product candidates. Such a lossof patent protection could have a material adverse impact on our business.

Changes to patent law in the United Statesand in foreign jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products.

As is the case with otherbiopharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcingpatents in the biopharmaceutical industry involve both technological and legal complexity, and is therefore costly, time-consuming andinherently uncertain. In addition, the United States continues to adapt to wide-ranging patent reform legislation, including legislationthat became effective starting in 2012. Moreover, recent U.S. Supreme Court rulings have narrowed the scope of patent protectionavailable in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertaintywith regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the valueof patents, once obtained. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulationsgoverning patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patentsand patents that we might obtain in the future. For example, in the case Assoc. for Molecular Pathology v. Myriad Genetics, Inc.,the U.S. Supreme Court held that certain claims to DNA molecules are not patentable. While we do not believe that any of the patentsowned by us will be found invalid based on this decision, we cannot predict how future decisions by the courts, Congress or the USPTOmay impact the value of our patents. Similarly, any adverse changes in the patent laws of other jurisdictions could have a material adverseeffect on our business and financial condition. Changes in the laws and regulations governing patents in other jurisdictions could similarlyhave an adverse effect on our ability to obtain and effectively enforce our patent rights.

We may not be able to protect our intellectualproperty rights throughout the world.

We may not be able to protectour intellectual property rights outside the United States. Filing, prosecuting and defending patents on product candidates in allcountries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United Statescan be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect intellectualproperty rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent thirdparties from practicing our inventions in all countries outside the United States, or from selling or importing products made usingour inventions in other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protectionto develop their own products and further, may export otherwise infringing products to territories where we have patent protection, butenforcement is not as strong as that in the United States. These products may compete with our products and our patents or otherintellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encounteredsignificant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countrieswhich we could expand to, particularly certain developing countries, do not favor the enforcement of patents, trade secrets and otherintellectual property protection, particularly those relating to biopharmaceutical products, which could make it difficult for us to stopthe infringement of our patents or marketing of competing products in violation of our proprietary rights generally. Proceedings to enforceour patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects ofour business, could put our patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuingand could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or otherremedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights aroundthe world may be 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 or independent contractors have wrongfully used or disclosed confidential information of third parties.

We have received confidentialand proprietary information from third parties. In addition, we employ individuals who were previously employed at other biotechnologyor pharmaceutical companies. We may be subject to claims that we or our employees, consultants or independent contractors have inadvertentlyor otherwise used or disclosed confidential information of these third parties or our employees’ former employers. Litigation maybe necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantialcost and be a distraction to our management and employees.

If we are unable to protect the confidentialityof our trade secrets, our business and competitive position would be harmed.

In addition to seeking patentprotection for our product candidates, we also rely on trade secrets, including unpatented know-how, technology and other proprietaryinformation, to maintain our competitive position. We seek to protect our trade secrets, in part, by entering into non-disclosure andconfidentiality agreements with parties who have access to them, such as our employees, consultants, advisors and other third parties.We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts,any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets. Monitoring unauthorizeduses and disclosures of our intellectual property is difficult, and we do not know whether the steps we have taken to protect our intellectualproperty will be effective. In addition, we may not be able to obtain adequate remedies for any such breaches. Enforcing a claim thata party illegally disclosed 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 competitorsmay independently develop knowledge, methods and know-how equivalent to our trade secrets. Competitors could purchase our products andreplicate some or all of the competitive advantages we derive from our development efforts for technologies on which we do not have patentprotection. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no rightto prevent them, or those to whom they communicate it, from using that technology or information to compete with us. If any of our tradesecrets were to be disclosed to or independently developed by a competitor, our competitive position would be harmed.

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

Because we will rely on thirdparties to research and develop and to manufacture our product candidates, we must share trade secrets with them. We seek to protect ourproprietary technology in part by entering into confidentiality agreements and, if applicable, material transfer agreements, consultingagreements or other similar agreements with our advisors, employees, third-party contractors and consultants prior to beginning researchor disclosing proprietary information. These agreements typically limit the rights of the third parties to use and disclose our confidentialinformation, including our trade secrets. Despite the contractual provisions employed when working with third parties, the need to sharetrade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are inadvertentlyincorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that our proprietary positionis based, in part, on our know-how and trade secrets, a competitor’s independent discovery of our trade secrets or other unauthorizeduse or disclosure would impair our competitive position and may have a material adverse effect on our business.

In addition, these agreementstypically restrict the ability of our advisors, employees, third-party contractors and consultants to publish data potentially relatingto our trade secrets, although our agreements may contain certain limited publication rights. For example, any academic institution thatwe may collaborate with will likely expect to be granted rights to publish data arising out of such collaboration and any joint R&Dprograms may require us to share trade secrets under the terms of our R&D or similar agreements. Despite our efforts to protect ourtrade secrets, our competitors may discover our trade secrets, either through breach of our agreements with third parties, independentdevelopment or publication of information by any of our third-party collaborators. A competitor’s discovery of our trade secretswould impair our competitive position and have an adverse impact on our business.

We may not have sufficient patent lifespanto effectively protect our products and business.

All of our patents are inearly stages. Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 yearsafter its earliest U.S. non-provisional filing date. Given the amount of time required for the development, testing and regulatoryreview of new product candidates, patents protecting such candidates might expire before or shortly after the resulting products are commercialized.As a result, our patents may not provide us with sufficient rights to exclude others from commercializing products similar or identicalto ours. We expect to seek extensions of patent terms for our issued patents, where available. This includes in the United Statesunder the Hatch-Waxman Act, which permits a patent term extension of up to five years beyond the original expiration date of thepatent as compensation for regulatory delays. However, such a patent term extension cannot lengthen the remaining term of a patent beyonda total of 14 years from the product’s approval date. Only one patent applicable to an approved drug is eligible for the extensionand the application for the extension must be submitted prior to the expiration of the patent. During the period of patent term extension,the claims of a patent are not enforceable for their full scope but are instead limited to the scope of the approved product. In addition,the applicable authorities, including the FDA in the United States, and any comparable foreign regulatory authorities, may not agreewith our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may grant more limitedextensions than we request. In addition, we may not be granted an extension because of, for example, failing to apply within applicabledeadlines, failing to apply prior to the expiration of relevant patents or otherwise failing to satisfy applicable requirements. The termsof our patents may also be affected by the filing of terminal disclaimers during prosecution before the USPTO and foreign authoritiesrecognizing similar disclaimer mechanisms. A patent subject to a terminal disclaimer may have its term limited so that its lifespan doesnot extend beyond the term of a related patent having a shorter term. If any of the foregoing occurs, any period during which we havethe right to exclusively market our product will be shorter than we would otherwise have expected, and our competitors may obtain approvalof and launch products earlier than might otherwise have been the case.

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

The life of a patent andthe protection it affords is limited. For example, in the United States, if all maintenance fees are timely paid, the natural expirationof a patent is generally 20 years from its earliest U.S. non-provisional filing date. In Europe, the expiration of an inventionpatent is 20 years from its filing date. Even if we successfully obtain patent protection for an approved product candidate, it mayface competition from biosimilar medications. Manufacturers of other drugs may challenge the scope, validity or enforceability of thepatents underlying our technology in court or before a patent office, and the patent holder may not be successful in enforcing or defendingthose intellectual property rights and, as a result, we may not be able to develop or market the relevant product candidate exclusively,which would materially adversely affect any potential sales of that product.

Given the amount of timerequired for the development, testing and regulatory review of new product candidates, patents protecting such product candidates mightexpire before or shortly after such product candidates are commercialized. As a result, the patents or pending applications licensed tous may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. Even if webelieve that the patents involved are eligible for certain (and time-limited) patent term extensions, there can be no assurance that theapplicable authorities, including the FDA and the USPTO, and any equivalent regulatory authority in other countries, will agree with ourassessment of whether such extensions are available, and such authorities may refuse to grant extensions to such patents, or may grantmore limited extensions than requested. Moreover, the applicable time period or the scope of patent protection afforded could be lessthan requested. If we are unable to obtain patent term extension or term of any such extension is less than requested, our competitorsmay obtain approval of competing products following our patent expiration, and our business could be harmed. Changes in either the patentlaws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrowthe scope of our patent protection.

The patent pending applicationsfor our product candidates are expected to expire on various dates. Upon the expiration, we will not be able to assert such licensed patentrights against potential competitors, which would materially adversely affect our business, financial condition, results of operationsand prospects.

Risks Related to Ownership of our Securities

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

The trading price of ourCommon Stock is likely to be highly volatile and could be subject to wide fluctuations in response to various factors, some of which arebeyond our control, including limited trading volume. In addition to the factors discussed in this “Risk Factors” sectionand elsewhere in this prospectus, these factors include:

In addition, the stock marketin general, and the markets for special purpose acquisition company (“SPAC”) post-business combination businesses and healthcarecompanies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate tothe operating performance of these companies. Broad market and industry factors may negatively affect the market price of our Common Stock,regardless of our actual operating performance. In addition, price volatility may be greater if the public float and trading volume ofour Common Stock is low. If the market price of our Common Stock falls, you may not realize any return on your investment and may losesome or all of your investment. In the past, securities class action litigation has often been instituted against companies followingperiods of volatility in the market price of a company’s securities. This type of litigation, if instituted, could result in substantialcosts and a diversion of management’s attention and resources, which would harm our business, operating results or financial condition.

Unstable market and economic conditionsmay have serious adverse consequences on our business, financial condition and stock price.

The global economy, includingcredit and financial markets, has experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability,declines in consumer confidence, declines in economic growth, increases in unemployment rates, increases in inflation rates, higher interestrates and uncertainty about economic stability. For example, the Russia-Ukraine war and the Israel-Hamas war created volatility in theglobal capital markets and may have further global economic consequences, including disruptions of the global supply chain and energymarkets. There have also been disruptions to the U.S. banking system due to bank failures in the past several years, including withrespect to Silicon Valley Bank, Signature Bank and First Republic Bank. Any such volatility and disruptions may have adverse consequenceson us or the third parties on whom it relies. If the equity and credit markets deteriorate, including as a result of political unrestor war, it may make any necessary debt or equity financing more difficult to obtain in a timely manner or on favorable terms, more costlyor more dilutive. 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 customersand potentially less demand for our products, if and when approved. Any significant increases in inflation and related increase in interestrates could have a material adverse effect on our business, results of operations and financial condition.

We do not intend to pay dividends on ourCommon Stock, so any returns will be limited to the value of its stock.

We currently anticipate thatwe will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or payingany cash dividends for the foreseeable future. In addition, future debt or other financing arrangements may contain terms prohibitingor limiting the amount of dividends that may be declared or paid on our Common Stock. Any return to stockholders will therefore be limitedin the foreseeable future to the appreciation of the market price (if any) of our stock.

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

We are an “emerginggrowth company” within the meaning of the Securities Act, as modified by the JOBS Act. For as long as we continue to be an emerginggrowth company, we may take advantage of certain exemptions from various public company reporting requirements that are applicable toother public companies that are not emerging growth companies, including being permitted to provide only two years of audited financialstatements, in addition to any required unaudited interim financial statements with correspondingly reduced “Management’sDiscussion and Analysis of Financial Condition and Results of Operations” disclosure, not being required to have its internal controlover financial reporting audited 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 the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any goldenparachute payments not previously approved. We may take advantage of these exemptions until the last day of the fiscal year endingafter the fifth anniversary of the consummation of our IPO or until we are no longer an emerging growth company, whichever is earlier.We will cease to be an emerging growth company prior to the end of such five-year period if certain earlier events occur, including ifwe become a “large accelerated filer” as defined in Rule 12b-2 under the Exchange Act, our annual gross revenuesequal or exceed $1.235 billion or we issue more than $1.0 billion of non-convertible debt in any three-year period prior tosuch time. In particular, in this prospectus on, we have provided only two years of audited financial statements and have not includedall of the executive compensation related information that would be required if it were not an emerging growth company, and it may electto take advantage of other reduced reporting requirements in future filings. Accordingly, the information contained herein may be differentthan the information you receive from other public companies in which you hold stock.

In addition, the JOBS Actprovides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accountingstandards. We have elected to take advantage of the extended transition period to comply with new or revised accounting standards andto adopt certain of the reduced disclosure requirements available to emerging growth companies. As a result of the accounting standardselection, we will not be subject to the same implementation timing for new or revised accounting standards as other public companies thatare not emerging growth companies, which may make comparison of its financials to those of other public companies more difficult. As aresult of these elections, the information that we provide in this prospectus may be different than the information you may receive fromother public companies in which you hold equity interests. In addition, it is possible that some investors will find our Common Stockless attractive as a result of these elections, which may result in a less active trading market for our Common Stock and higher volatilityin its share price.

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

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

Our operations to date havebeen primarily limited to researching and developing our product candidates. We have not yet obtained regulatory approvals for any ofits product candidates. Consequently, any predictions you make about our future success or viability may not be as accurate as they couldbe if we had a longer operating history or approved products on the market.

Our quarterly and annualoperating results may fluctuate significantly in the future, which makes it difficult for us to predict future operating results. Fromtime to time, we may enter into license or collaboration agreements with other companies that include development funding and significantupfront and milestone payments and/or royalties, which may become an important source of our revenue. Accordingly, our revenue may dependon development funding and the achievement of development and clinical milestones under current and any potential future license and collaborationagreements and sales of our drugs, if approved. These upfront and milestone payments may vary significantly from period to period andany such variance could cause a significant fluctuation in operating results from one period to the next.

In addition, our measurescompensation cost for stock-based awards made to employees, directors and non-employee consultants based on the fair value of the awardon the grant date and we recognize the cost as an expense over the requisite service period, as applicable. Because the variables thatwe uses as a basis for valuing stock-based awards change over time, including our underlying stock price and stock price volatility, themagnitude of the expense that we must recognize may vary significantly.

Furthermore, operating resultsmay fluctuate due to a variety of other factors, many of which are outside of our control and may be difficult to predict, including thefollowing:

The cumulative effect ofsuch factors could result in large fluctuations and unpredictability in quarterly and annual operating results. As a result, comparingoperating results on a period-to-period basis may not be meaningful. Investors should not rely on past results as an indication of futureperformance. This variability and unpredictability could also result in our failing to meet the expectations of industry or financialanalysts or investors for any period. If our revenue or operating results fall below the expectations of analysts or investors or belowany forecasts we may provide to the market, or if the forecasts 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 previouslypublicly stated revenue and/or earnings guidance we may provide.

Anti-takeover provisions under our organizationaldocuments and Delaware law could delay or prevent a change of control which could limit the market price of our Common Stock and may preventor frustrate attempts by our stockholders to replace or remove our then-current management.

Our Charter and Bylaws, containprovisions that could delay or prevent a change of control of our board of directors that our stockholders might consider favorable. Someof these provisions include:

In addition, because we areincorporated in Delaware, we are governed by the provisions of Section 203 of the DGCL, which may prohibit certain business combinationswith stockholders owning 15% or more of our outstanding voting stock. These anti-takeover provisions and other provisions in our Charteror Bylaws could make it more difficult for stockholders or potential acquirors to obtain control of our board of directors or initiateactions that are opposed by the then-current board of directors and could also delay or impede a merger, tender offer, or proxy contest.These provisions could also discourage proxy contests and make it more difficult for you and other stockholders to elect directors ofyour choosing or cause us to take other corporate actions you desire. Any delay or prevention of a change of control transaction or changesin our board of directors could cause the market price of our Common Stock to decline.

If we engage in future acquisitions or strategicpartnerships, this may increase capital requirements, dilute stockholders, cause us to incur debt or assume contingent liabilities, andsubject us to other risks.

We intend to evaluate variousacquisition opportunities and 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 undertakeacquisitions, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangibleassets that could result in significant future amortization expense. Moreover, we may not be able to locate suitable acquisition opportunities,and this inability could impair our ability to grow or obtain access to technology or products that may be important to the developmentof our business.

Our Bylaws provide that the Court of Chanceryof the State of Delaware and, to the extent enforceable, the federal district courts of the United States of America will be the exclusiveforums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorablejudicial forum for disputes with us or our directors, officers, or employees.

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

This provision would notapply to suits brought to enforce a duty or liability created by the Exchange Act. Furthermore, Section 22 of the SecuritiesAct creates concurrent jurisdiction for federal and state courts over all such Securities Act actions. Accordingly, both state and federalcourts have jurisdiction to entertain such claims. To prevent having to litigate claims in multiple jurisdictions and the threat of inconsistentor contrary rulings by different courts, among other considerations, the Charter further provides that, unless we consent to the selectionof an alternative forum, the federal district courts of the United States of America will be the exclusive forum for resolving anycomplaint asserting a cause of action arising under the Securities Act, including all causes of action asserted against any defendantnamed in such complaint. While the Delaware courts have determined that such choice of forum provisions are facially valid and severalstate trial courts have enforced such provisions and required that suits asserting Securities Act claims be filed in federal court, thereis no guarantee that courts of appeal will affirm the enforceability of such provisions and a stockholder may nevertheless seek to bringa claim in a venue other than those designated in the exclusive forum provisions. In such instance, we would expect to vigorously assertthe validity and enforceability of the exclusive forum provisions of the Charter. This may require significant additional costs associatedwith resolving such action in other jurisdictions and there can be no assurance that the provisions will be enforced by a court in thoseother jurisdictions. If a court were to find either exclusive forum provision in the Charter to be inapplicable or unenforceable in anaction, we may incur further significant additional costs associated with litigating Securities Act claims in state court, or both stateand federal court, which could seriously harm our business, financial condition, results of operations, and prospects. These exclusiveforum provisions may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes withus or our directors, officers, or other employees, or could result in increased costs for a stockholder to bring a claim, particularlyif they do not reside in or near Delaware, both of which may discourage lawsuits against us and our directors, officers and other employees.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 resolving the dispute in other jurisdictions, all of which could seriously harm ourbusiness.

We will incur increased costs and demandsupon management as a result of complying with the laws and regulations affecting public companies, which could adversely affect our business,results of operations, and financial condition.

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

In addition, changing laws,regulations and standards relating to corporate governance and public disclosure are creating uncertainty for public companies, increasinglegal and financial compliance costs, and making some activities more time-consuming. These laws, regulations and standards are subjectto varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolveover time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliancematters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We intend to invest substantial resourcesto comply with evolving laws, regulations and standards, and this investment may result in increased general and administrative expensesand a diversion of management’s time and attention from business operations to compliance activities. If our efforts to comply withnew laws, regulations and standards differ from the activities intended by regulatory or governing bodies due to ambiguities related totheir application and practice, regulatory authorities may initiate legal proceedings against us and our business may be harmed.

We also expect that beinga public company and these new rules and regulations will make it more expensive for us to obtain director and officer liability insurance,and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage. These factors could also makeit more difficult for us 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 disclosureof information in the filings required of a public company, our business and financial condition will become more visible, which may resultin an increased risk of threatened or actual litigation, including by competitors and other third parties. If such claims are successful,our business and 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 to develop and maintain proper and effective internal controls over financial reporting and any failure to maintain theadequacy of these internal controls may adversely affect investor confidence in our company and, as a result, the value of our commonstock.

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

We may identify weaknessesin our system of internal financial and accounting controls and procedures that could result in a material misstatement of our consolidatedfinancial statements. Our control over financial reporting will not prevent or detect all errors and all fraud. A control system, no matterhow well designed and operated, can provide only reasonable, not absolute, assurance that the control system’s objectives will bemet. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that misstatementsdue to error or fraud will not occur or that all control issues and instances of fraud will be detected.

Any failure to maintain internalcontrol over financial reporting could severely inhibit our ability to accurately report our financial condition, results of operationsor cash flows. If our financial statements are not accurate, investors may not have a complete understanding of our operations. If wedo not file financial statements on a timely basis as required by the SEC, we could face severe consequences. If we are unable to concludethat its internal control over financial reporting is effective, investors may lose confidence in the accuracy and completeness of ourfinancial 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 other regulatory authorities. Moreover, responding to such investigations, are likely to consume a significant amount of ourmanagement resources and cause us to incur significant legal and accounting expenses. Failure to remedy any material weakness in internalcontrol over financial reporting, or to maintain effective control systems, could also restrict our future access to the capital markets.This could result in an 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 subjectto filing deadlines for reports that we file pursuant to the Exchange Act, and our failure to timely file such reports may have materialadverse consequences on our business.

Following the consummationof the Business Combination, we failed to timely file our Form 8-K with Form 10 information prior to the “staleness” date(as determined in accordance with the applicable rules and regulations of the SEC) applicable to the financial statements that were requiredby the applicable accounting requirements and other rules and regulations of the SEC to be included in such filing (including pro formafinancial information); thus, we have not remained current in our reporting requirements with the SEC since we became an SEC reportingcompany on February 14, 2024. Although we have since regained status as a current filer by filing a Form 8-K/A with current financialstatements on April 1, 2024, we will not be eligible to use a registration statement on Form S-3 that would allow us to continuously incorporateby reference our SEC reports into the registration statement, or to use “shelf” registration statements to conduct offerings,until approximately one year from the date we regained (and maintain) status as a current filer. Until such time, if we determine to pursuean offering, we would be required to conduct the offering on an exempt basis, such as in accordance with Rule 144A, or file a registrationstatement on Form S-1. Using a Form S-1 registration statement for a public offering would likely take significantly longer than usinga registration statement on Form S-3 and increase our transaction costs, and could, to the extent we are not able to conduct offeringsusing alternative methods, adversely impact our liquidity, ability to raise capital or complete acquisitions in a timely manner. The useof Form S-1 would also prevent us from conducting offerings on a “shelf basis,” limiting our flexibility as to the terms,timing or manner of any such offering.

We cannot guarantee thatin the future our reporting will always be timely. If we are unable to satisfy SEC filing deadlines or otherwise provide disclosures ofmaterial information on a timely basis, stockholders and potential investors in our Common Stock may have incomplete information aboutour business and results of operations, which may impact their ability to make an informed investment decision, result in a reductionin the trading price, trading volume or analyst coverage of our Common Stock or expose us to potential liability.

We could be subject to securities classaction litigation.

In the past, securities classaction litigation has often been brought against a company following a decline in the market price of its securities. This risk is especiallyrelevant for us because biopharmaceutical companies have experienced significant stock price volatility in recent years. If we facesuch litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harmour business.

Any such negative outcomecould result in payments of substantial damages or fines, damage to our reputation or adverse changes to our business practices. Defendingagainst litigation is costly and time-consuming, and could divert management’s attention and our resources. Furthermore, duringthe course of litigation, there could be negative public announcements of the results of hearings, motions or other interim proceedingsor developments, which could have a negative effect on the market price of the our Common Stock.

Our failure to meet the continued listingrequirements of Nasdaq could result in a delisting of its securities.

On July 19, 2024, we receivedthe Bid Price Requirement Letter from the staff at Nasdaq notifying us that, for the 30 consecutive trading days prior to the date ofthe Bid Price Requirement Letter, the closing bid price for the Common Stock has been below the minimum $1.00 per share required for continuedlisting on Nasdaq set forth in Nasdaq Listing Rule 450(a)(1), which is required for continued listing of the Common Stock on Nasdaq (the“Bid Price Requirement”). On October 23, 2024, the trading price for our Common Stock closed under $0.10 and was the tenthconsecutive trading day to do so.

On October 24, 2024, we receiveda letter from the staff at Nasdaq notifying us that, because our Common Stock had a closing bid price of $0.10 or less for ten consecutivetrading days, it was no longer eligible to rely upon the 180-day cure period set forth in the Bid Price Requirement Letter. In addition,on October 30, 2024, the Company received a letter from the staff at Nasdaq notifying the Company that it had not regained compliancewith the continued listing requirement to maintain a minimum market value of $50,000,000 for its listed securities within the 180-daycompliance period granted by Nasdaq in May 2024.

On July 19, 2024, we alsoreceived a letter the MVPHS Letter from Nasdaq notifying the Company that the Market Value of Publicly Held Shares the MVPHS of the CommonStock had been below the minimum of $15,000,000 for the last 30 consecutive business days prior to the date of the MVPHS Letter, per theMVPHS Requirement.

Each of the Bid Price Requirementand MVLS Requirement deficiencies results in the commencement of delisting proceedings. However, we have requested a hearing from Nasdaqwhich will be held on December 17, 2024, and plan to submit a plan to regain compliance with the listing requirements at such hearing.All other delisting actions will be stayed through the hearing decision or any time provided by the hearing panel. The panelwill issue a decision, typically within 30 days of the hearing date, either granting us an extension in which to regain compliance ordenying our request and moving to delist our securities from Nasdaq. Such a delisting would likely have a negative effect on the priceof the securities and would impair your ability to sell or purchase the securities when you wish to do so. In the event of a delisting,any action taken by us to restore compliance with listing requirements may not allow our securities to become listed again, stabilizethe market price or improve the liquidity of our securities, prevent our securities from dropping below the Nasdaq minimum share pricerequirement or prevent future non-compliance with Nasdaq’s listing requirements. Additionally, if our securities are not listedon, or become delisted from Nasdaq for any reason, and are quoted on the over-the-counter bulletin board, an inter-dealer automated quotationsystem for equity securities that is not a national securities exchange, the liquidity and price of our securities may be more limitedthan if we were quoted or listed on Nasdaq or another national securities exchange.

If securities or industry analysts do notpublish research, or publish inaccurate or unfavorable research, about our business, our Common Stock share price and trading volume coulddecline.

The trading market for ourCommon 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 or industry analysts cover us, the trading price for our Common Stock would likely be negatively impacted. Ifone or more of the analysts who cover us downgrade our Common Stock or publish inaccurate or unfavorable research about our business,our share price would likely decline. In addition, if our operating results fail to meet the forecast of analysts, our share price wouldlikely decline. If one or more of these analysts cease coverage of us or fail to publish reports on us regularly, demand for our CommonStock could decrease, which might cause our share price and trading volume to decline.

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

Due to the significant numberof redemptions of Class A Common Stock, in connection with the Business Combination, there was a significantly lower number of sharesof Class A Common Stock that converted into shares of our Common Stock in connection with the Business Combination. As a result, the sharesof our Common Stock being registered for resale are anticipated to constitute a considerable percentage of our public float. Additionally,a significant portion of the shares of our Common Stock being registered for resale were purchased by 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 SellingSecurityholder.

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

Our Warrants are exercisable for CommonStock, the exercise of which would increase the number of shares eligible for future resale in the public market and result in dilutionto our shareholders.

As of November 21, 2024,there were 18,305,411 Common Warrants with an exercise price ranging from $1.39 to $11.50 per share, which are exercisable into 18,305,411shares of Common Stock. To the extent such warrants are exercised, additional shares of our Common Stock will be issued, which will resultin dilution to the holders of our Common Stock and increase the number of shares eligible for resale in the public market. Sales of substantialnumbers of such shares in the public market could adversely affect the market price of our Common Stock, the impact of which increasesas the value of our stock price increases.

Our Warrants may not be exercised at alland we may not receive any cash proceeds from the exercise of the Warrants.

Holders of our Warrants willbe less likely to exercise their Warrants if the exercise prices of their Warrants exceed the market price of our Common Stock. Thereis no guarantee that our Warrants will continue to be in the money prior to their expiration, and as such, the Warrants may expire worthless.As such, any cash proceeds that we may receive in relation to the exercise of the Warrants overlying shares of Common Stock will be dependenton the trading price of our Common Stock. There is no assurance that the holders of the Warrants will elect to exercise any or all ofsuch Warrants. As of the date of this prospectus (i) all of the Private Placement Warrants and Public Warrants, which have an exerciseprice 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 SeriesA Warrants, which have a current exercise price of $1.39 per share, are “out of the money,” meaning the exercise price ishigher than the market price of our Common Stock. Holders of such “out of the money” Warrants are not likely to exercise suchWarrants. There can be no assurance that such Warrants will be in the money prior to their respective expiration dates, and therefore,we may not receive any cash proceeds from the exercise of such Warrants.

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

We evaluated the accountingtreatment of our Earnout Shares (as defined below) subject to forfeiture if the applicable conditions to transferability thereof are notsatisfied and determined to classify such shares as liabilities measured at fair value. The fair value of such shares is remeasured ona quarterly basis over the earn-out period with changes in the estimated fair value recorded in Other (expense) income on the condensedconsolidated statement of operations and comprehensive loss. Due to the recurring fair value measurement, we expect that we will recognizenon-cash gains or losses on our Earnout Shares each reporting period and that the amount of such gains or losses could materially impactor cause volatility in our financial results. 

THE COMMITTEDEQUITY FINANCING

Overview

In February 2024 and November2024, we entered into the Keystone Purchase Agreements with Keystone. As of the date of this prospectus, we have issued and sold 23,377,921shares of Common Stock for aggregate proceeds of $4,410,616 under the Keystone Equity Financing.

Sales of our Common Stockto Keystone under the Keystone Purchase Agreements, and the timing of any sales, will be determined by us from time to time in our solediscretion and will depend on a variety of factors, including, among other things, market conditions, the trading price of our CommonStock and determinations by us regarding the use of proceeds from any sale of such Common Stock. The net proceeds from any sales underthe Keystone Equity Financing will depend on the frequency with, and prices at, which the Common Stock are sold to the Selling Securityholder.To the extent we sell shares under the Keystone Purchase Agreements, we currently plan to use any proceeds therefrom for working capitaland other general corporate purposes. Pending other uses, we intend to invest the net proceeds to us in investment-grade, interest-bearingsecurities such as money market funds, certificates of deposit, or direct or guaranteed obligations of the U.S. government, or hold ascash. We cannot predict whether the net proceeds invested will yield a favorable return.

Keystone is not obligatedto buy any Common Stock under the Keystone Purchase Agreements if such shares, when aggregated with all other Common Stock then beneficiallyowned by Keystone and its respective affiliates (as calculated pursuant to Section 13(d) of the Exchange Act and Rule 13d-3 promulgatedthereunder), would result in Keystone beneficially owning Common Stock in excess of 4.99% of the then-outstanding shares of Common Stock(the “Beneficial Ownership Limitation”).

Concurrentwith the execution of the Keystone Purchase Agreements, we entered into the Keystone Registration Rights Agreements, pursuant to whichwe agreed to provide Keystone with customary registration rights related to the shares issued under the Keystone Purchase Agreements.

The Keystone Purchase Agreementsand Keystone Registration Rights Agreements contain customary registration rights, representations, warranties, conditions and indemnificationobligations by each party. The representations, warranties and covenants contained in such agreements were made only for purposes of suchagreements and as of specific dates, were solely for the benefit of the parties to such agreements and are subject to certain importantlimitations.

Keystone Purchase Agreements and RegistrationStatements

InFebruary 2024, we entered into the Old Keystone Purchase Agreement with Keystone, pursuant to which we may sell and issue, and Keystoneis obligated to purchase, up to $25,000,000 of shares of Common Stock; provided that the number of shares issued pursuant to the Old KeystonePurchase Agreement shall not exceed 25,000,000 shares (the “Initial Limit”).

In accordance with our obligationsunder the Old Keystone Purchase Agreement and the Old Keystone Registration Rights Agreement, we previously filed the Prior RegistrationStatement in order to register the resale of up to: (i) 25,000,000 Keystone Purchase Shares that we may elect, in our sole discretion,to issue and sell to Keystone, from time to time from and after the Keystone Commencement Date upon the terms and subject to the conditionsand limitations of the Old Keystone Purchase Agreement, subject to applicable stock exchange rules (assuming the shares are sold at aprice of $1.00 per share) and (ii) 619,050 Keystone Commitment Shares that have been issued to Keystone as consideration for its executionand delivery of the Old Keystone Purchase Agreement (assuming the shares to be issued are sold at a price of $1.00 per share).

InNovember 2024, in order to enable us to issue and sell additional shares in excess of the Initial Limit and up to $25,000,000, we enteredinto the New Keystone Purchase Agreement with Keystone, pursuant to which we may issue and sell up to $20,589,384 of shares of CommonStock.

The shares of our CommonStock that may be issued under the Keystone Purchase Agreements may be sold by us to Keystone at our discretion from time to time fromthe applicable Keystone Commencement Date until the earliest to occur of (i) the 36-month anniversary of the effective date of the applicableRegistration Statement, (ii) the date on which Keystone has purchased the Keystone Commitment Amount pursuant to the Keystone PurchaseAgreements, (iii) the date on which our Common Stock fails to be listed or quoted on Nasdaq or any successor Eligible Market (as definedin the Keystone Purchase Agreements), and (iv) the date on which, pursuant to or within the meaning of any bankruptcy law, a custodianis appointed for us or for all or substantially all of our property, or we make a general assignment for the benefit of our creditors(each, a “Termination Event”).

Although the Keystone PurchaseAgreements provides that we may sell up to an aggregate of $25.0 million of our shares of our Common Stock to Keystone, we have only registeredan aggregate of 210,000,000 shares of Common Stock for resale under the Registration Statements. If it becomes necessary for us to issueand sell to Keystone under the Keystone Purchase Agreements more shares than are being registered for resale under the Registration Statementsin order to receive aggregate gross proceeds equal to $25.0 million under the Keystone Purchase Agreements, we must first file with theSEC one or more additional registration statements to register under the Securities Act the resale by Keystone of any such additionalshares of our Common Stock we wish to sell from time to time under the Keystone Purchase Agreements, which the SEC must declare effective,in each case, before we may elect to sell any additional shares of our Common Stock to Keystone under the Keystone Purchase Agreements.

Purchases of Shares of our Common Stock Underthe Keystone Purchase Agreements

During the termdescribed above, on any business day on which the closing sale price of the Common Stock isequal to or greater than $0.01 (the “Fixed Purchase Date”), we willhave the right, but not the obligation, from time to time at our sole discretion, to direct Keystone, by delivery of an irrevocablewritten notice (a “Fixed Purchase Notice”), to purchase a number of shares of our Common Stock upto the lesser of 10,000 shares of Common Stock or $100,000 (the “Fixed Purchase Maximum Amount”) at a purchase priceequal to the lesser of 90% of (i) the daily VWAP (as defined below) of the Common Stockfor the five trading days immediately preceding the applicable Fixed Purchase Date and (ii) the closing price of a share of CommonStock on the applicable Fixed Purchase Date during the full trading day on such applicable Purchase Date (the “Fixed PurchasePrice”).

Inaddition, at any time from and after the Keystone Commencement Date, on any business dayon which the closing sale price of the Common Stock is equal to or greater than $0.01 and such business day is also the Fixed PurchaseDate for a Fixed Purchase of an amount of shares of Common Stock not less than the applicable Fixed Purchase Maximum Amount, wemay also direct Keystone, by delivery of an irrevocable written notice (a “VWAP Purchase Notice”), to purchase, on the immediatelyfollowing business day (the “VWAP Purchase Date”), an additional number of shares of Common Stock in an amount equal to thelesser of (i) 300% of the number of shares of Common Stock directed by us to be purchased by Keystone for the applicable Fixed Purchaseand (ii) 30% of the trading volume in our Common Stock on Nasdaq during the applicable VWAP Purchase Period (as defined in the KeystonePurchase Agreements) on the applicable VWAP Purchase Date (a “VWAP Purchase”), at a purchase price equal to the lesser of90% of (i) the closing sale price of the Common Stock on the applicable VWAP Purchase Date and (ii) the VWAP during the applicable VWAPPurchase Period (the “VWAP Purchase Price”).

At any time from and afterthe Keystone Commencement Date, on any business day that is also the VWAP Purchase Date for a VWAP Purchase, we may also direct Keystone,by delivery of an irrevocable written notice (an “Additional VWAP Purchase Notice” and, together with a Fixed Purchase Noticeand a VWAP Purchase Notice, a “Purchase Notice”), to purchase, on the same business day (the “Additional VWAP PurchaseDate” and, together with a Fixed Purchase Date and a VWAP Purchase Date, the “Purchase Dates”), an additional numberof shares of Common Stock in an amount equal to the lesser of (i) 300% of the number of shares of Common Stock directed by us to be purchasedby Keystone for the applicable Fixed Purchase and (ii) 30% of the trading volume in our Common Stock on Nasdaq during the applicable AdditionalVWAP Purchase Period (as defined in the Keystone Purchase Agreements) on the applicable VWAP Purchase Date (an “Additional VWAPPurchase” and, together with a Fixed Purchase and a VWAP Purchase, the “Purchases”) at a purchase price equal to thelesser of 90% of (i) the closing sale price of the Common Stock on the applicable Additional VWAP Purchase Date and (ii) the VWAP duringthe Additional VWAP Purchase Period (as defined in the Keystone Purchase Agreements) (the “Additional VWAP Purchase Price”and, together with a Fixed Purchase Price and a VWAP Purchase Price, the “Purchase Prices”).

For purposes of the KeystonePurchase Agreements, “VWAP” is, for the Common Stock for a specified period, the dollar volume-weighted average price forthe Common Stock on Nasdaq, for such period, as reported by Bloomberg through its “AQR” function. All such determinationsshall be appropriately adjusted for any sales of shares of Common Stock through block transactions, any reorganization, non-cash dividend,stock split, reverse stock split, stock combination, recapitalization or other similar transaction during such period.

Commitment Shares and Fees

As consideration for itsirrevocable commitment to purchase our Common Stock under the Keystone Purchase Agreements, we have issued to Keystone 1,983,345 sharesof Common Stock as Keystone Commitment Shares in accordance with the Keystone Purchase Agreements. We previously registered the resaleof 619,050 Keystone Commitment Shares on the Prior Registration Statement. The remaining 1,364,295 Keystone Commitment Shares are beingregistered under the registration statement of which this prospectus forms a part.

We have also paid to Keystone$50,000 in cash as reimbursement for the reasonable, out-of-pocket expenses incurred by Keystone, including the legal fees and disbursementsof Keystone’s legal counsel, in connection with its due diligence investigation of our company and in connection with the preparation,negotiation and execution of the Keystone Purchase Agreements.

Conditions Precedent to Commencement

Our right to commence deliveringPurchase Notices under the Keystone Purchase Agreements and Keystone’s obligation to accept such Purchase Notices, are subject tothe initial satisfaction, at the applicable Keystone Commencement Date, of the conditions precedent thereto set forth in the KeystonePurchase Agreements, which conditions include, among others, the following:

Termination of the Keystone Purchase Agreements

Unless earlier terminatedas provided in the Keystone Purchase Agreements, the Keystone Purchase Agreements will terminate automatically on the earliest to occurof:

We have the right to terminatethe Keystone Purchase Agreements at any time after the Keystone Commencement Date, at no cost or penalty, upon one trading days’prior written notice to Keystone, provided that we shall have issued all Keystone Commitment Shares to Keystone prior to such termination.We and Keystone may also terminate the Keystone Purchase Agreements at any time by mutual written consent. Keystone also has the rightto terminate the Keystone Purchase Agreements upon 10 trading days’ prior written notice to us, but only upon the occurrence ofcertain customary events as listed in the Keystone Purchase Agreements. No termination of the Keystone Purchase Agreements by us or byKeystone will become effective prior to the first trading day immediately following the date on which any pending Purchase has been fullysettled in accordance with the terms and conditions of the Keystone Purchase Agreements, and will not affect any of our respective rightsand obligations under the Keystone Purchase Agreements with respect to any pending Purchase, and both we and Keystone have agreed to completeour respective obligations with respect to any such pending Purchase under the Keystone Purchase Agreements.

Prohibition of “Dilutive Issuances”During Pending Purchases

Subject to certain exceptions,during any Reference Period (as defined in the Keystone Purchase Agreements) with respect to a Purchase, we are limited in our abilityto issue any Common Stock, or any securities convertible into Common Stock, at an effective price per share of Common Stock less thanthe applicable Purchase Price to be sold to Keystone in the applicable Purchase to which such Reference Period relates.

No Short-Selling or Hedging

Each Selling Securityholderhas agreed that neither it nor any entity managed or controlled by it, will engage in, directly or indirectly, any (i) “short sale”(as such term is defined in Rule 200 of Regulation SHO of the Exchange Act) of the Common Stock or (ii) hedging transaction, which, withrespect to items (i) and (ii), establishes a net short position with respect to the Common Stock, during the term of the Keystone PurchaseAgreements.

Effect of Sales of our Common Stock under theKeystone Purchase Agreements on our Stockholders

The Common Stock being registeredfor resale in this offering may be issued and sold by us to the Selling Securityholder from time to time at our discretion, during theterms described above. The resale by the Selling Securityholder of a significant quantity of shares registered for resale in this offeringat any given time, or the perception that these sales may occur, could cause the market price of our Common Stock to decline and to behighly volatile. Sales of our Common Stock, if any, to Keystone under the Keystone Purchase Agreements will be determined by us in oursole discretion, subject to the satisfaction of certain conditions in the Keystone Purchase Agreements, and will depend upon market conditionsand other factors. We may ultimately decide to sell to Keystone all, some or none of the Common Stock that may be available for us tosell to Keystone pursuant to the Keystone Purchase Agreements. If we elect to sell Common Stock to Keystone pursuant to the Keystone PurchaseAgreements, after Keystone has acquired such shares, Keystone may resell all, some or none of such Common Stock at any time or from timeto time in its discretion and at different prices. As a result, investors who purchase Common Stock from Keystone in this offering atdifferent times will likely pay different prices for those shares of Common Stock, and so may experience different levels of dilutionand in some cases substantial dilution and different outcomes in their investment results. See “Risk Factors—Risks Relatedto the Keystone Equity Financing—Investors who buy shares of Common Stock from Keystone at different times will likely pay differentprices.”

Investors may experiencea decline in the value of the Common Stock they purchase from Keystone in this offering as a result of future sales made by us to Keystoneat prices lower than the prices such investors paid for their shares in this offering. In addition, if we sell a substantial number ofshares of Common Stock to Keystone under the Keystone Purchase Agreements, or if investors expect that we will do so, the actual salesof Common Stock or the mere existence of our arrangement with Keystone may make it more difficult for us to sell equity or equity-relatedsecurities in the future at a time and at a price that we might otherwise wish to effect such sales.

Because the purchase priceper share to be paid by Keystone for the Common Stock that we may elect to sell to Keystone under the Keystone Purchase Agreements, ifany, will fluctuate based on the market prices of our Common Stock at the time we make such election, as of the date of this prospectus,it is not possible for us to predict the number of shares of Common Stock that we will sell to Keystone under the Keystone Purchase Agreements,the actual purchase price per share to be paid by Keystone for those shares of Common Stock, or the actual gross proceeds to be raisedby us from those sales, if any. As of November 21, 2024, there were 150,312,572 shares of Common Stock outstanding. If all of the 210,000,000shares of our Common Stock offered for resale by the Selling Securityholder under this prospectus were issued and outstanding as of November21, 2024, such shares would represent approximately 58.3% of total number of shares of our fully-diluted Common Stock outstanding. Theactual number of shares of our Common Stock issuable will vary depending on the then current market price of shares of our Common Stocksold to the Selling Securityholder in this offering.

The number of shares of CommonStock ultimately offered for sale by the Selling Securityholder for resale under this prospectus is dependent upon the number of sharesof Common Stock, if any, we ultimately sell to Keystone under the Keystone Purchase Agreements. Further, if and when we elect to sellshares of Common Stock to Keystone pursuant to the Keystone Purchase Agreements, after Keystone has acquired such shares, Keystone mayresell all, some or none of such shares of Common Stock at any time or from time to time in its discretion and at different prices.

The issuance of our sharesof Common Stock to the Selling Securityholder pursuant to the Purchase Agreements will not affect the rights or privileges of our existingstockholders, except that the economic and voting interests of each of our existing stockholders will be diluted. Although the numberof shares of Common Stock that our existing stockholders own will not decrease, the shares of Common Stock owned by our existing stockholderswill represent a smaller percentage of our total outstanding shares of Common Stock after any such issuance.

Although the Keystone PurchaseAgreements provides that we may sell up to an aggregate of $25.0 million of our shares of our Common Stock to Keystone, we have only registeredan aggregate of 210,000,000 shares of Common Stock for resale under the Registration Statements, including 208,635,705 Keystone Purchase Sharespursuant to the registration statement of which this prospectus forms a part. If it becomes necessary for us to issue and sell more sharesthan are being registered for resale under the Registration Statements in order to receive aggregate gross proceeds equal to $25.0 millionunder the Keystone Purchase Agreements, we must first file with the SEC one or more additional registration statements to register underthe Securities Act the resale by Keystone of any such additional shares of our Common Stock we wish to sell from time to time under theKeystone Purchase Agreements, which the SEC must declare effective, in each case, before we may elect to sell any additional shares ofour Common Stock to Keystone under the Keystone Purchase Agreements.

The following table setsforth the number of Keystone Purchase Shares to be issued to Keystone under the New Keystone Purchase Agreement registered hereunder atvarying purchase prices: