The information in the accompanying proxy statement/prospectus is not complete and may be changed. A registration statement relating to the securities described in this proxy statement/prospectus has been filed with the U.S. Securities and Exchange Commission. These securities may not be issued until the registration statement filed with the U.S. Securities and Exchange Commission is effective. This proxy statement/prospectus does not constitute an offer to sell or the solicitation of offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

PRELIMINARY—SUBJECT TO COMPLETION—DATED JUNE 8, 2023

PROXY STATEMENT OF APEXIGEN, INC.	PROSPECTUS OF PYXIS ONCOLOGY, INC.

MERGER PROPOSED – YOUR VOTE IS VERY IMPORTANT

Dear Apexigen Stockholders:

As previously announced, the board of directors of Apexigen, Inc. (“Apexigen”) has approved an acquisition of Apexigen by Pyxis Oncology, Inc. (“Pyxis Oncology”). Apexigen, Pyxis Oncology, and Ascent Merger Sub Corp., a wholly owned subsidiary of Pyxis Oncology (“Merger Sub”), entered into an Agreement and Plan of Merger, dated as of May 23, 2023 (the “Merger Agreement”), pursuant to which Merger Sub will merge with and into Apexigen (the “Merger”), with Apexigen continuing as a wholly owned subsidiary of Pyxis Oncology.

If the transaction is completed, Apexigen stockholders will have the right to receive for each share of Apexigen common stock, par value $0.0001 per share (“Apexigen common stock”), held by such stockholder 0.1725 shares of Pyxis Oncology common stock, par value $0.001 per share (“Pyxis Oncology common stock”), (the “Exchange Ratio”), aggregated and rounded down to the nearest whole share. The Exchange Ratio is fixed, and will not reflect changes in the market price of either Apexigen common stock or Pyxis Oncology common stock. Upon completion of the Merger and based on         shares of Pyxis Oncology common stock and           shares of Apexigen common stock outstanding as of         , 2023, it is expected that Pyxis Oncology stockholders and certain other equity holders will own approximately 90% of the outstanding common stock of the combined company and Apexigen stockholders and certain other equityholders will own approximately 10% of the outstanding common stock of the combined company, in each case, on a fully diluted basis.

Because the Exchange Ratio is fixed, the market value of the shares of Pyxis Oncology common stock to be issued to Apexigen stockholders at the closing of the Merger (the “Merger Consideration”) will fluctuate with the market price of Pyxis Oncology common stock and will not be known at the time that Apexigen stockholders vote on the Merger. Based on the price of Pyxis Oncology common stock of $3.62 on The Nasdaq Global Select Market on May 22, 2023, the last full trading day before the parties entered into the Merger Agreement, the implied value of the Merger Consideration to Apexigen stockholders was approximately $0.62 per share of Apexigen common stock. On June       , 2023, which was the most recent practicable date before the date of this proxy statement/prospectus, the closing price of Pyxis Oncology common stock was $      per share, resulting in an implied value of the Merger Consideration to Apexigen stockholders of $        per share of Apexigen common stock.

We encourage you to obtain current market quotations of Pyxis Oncology common stock and Apexigen common stock before voting. Pyxis Oncology common stock is traded on The Nasdaq Global Select Market under the symbol “PYXS” and Apexigen common stock is traded on The Nasdaq Capital Market under the symbol “APGN”. Upon completion of the Merger, Apexigen common stock will cease to trade on The Nasdaq Capital Market.

At the special meeting of Apexigen stockholders to be held virtually on                    , 2023 (the “Apexigen special meeting”), Apexigen stockholders will be asked to vote on (i) a proposal to adopt the Merger Agreement (the “Apexigen merger proposal”) and (ii) a proposal to approve the adjournment from time to time of the Apexigen special meeting, if necessary, to solicit additional proxies if there are  insufficient shares of Apexigen common stock present or represented by proxy at the Apexigen special meeting to constitute a quorum at the Apexigen special meeting or any adjournment or postponement thereof (the “Apexigen adjournment proposal”).

Only holders of record of Apexigen common stock on          , 2023 (including shares of Apexigen common stock held through a bank, broker or other nominee that is a stockholder of record of Apexigen) are entitled to attend and vote at the Apexigen special meeting, or any adjournment or postponement thereof.

We cannot complete the Merger unless the Apexigen stockholders approve the Apexigen merger proposal.

Your vote is very important, regardless of the number of shares you own. Whether or not you expect to attend the Apexigen special meeting, please vote your shares as promptly as possible by (1) accessing the Internet website specified on your proxy card, (2) calling the toll-free number specified on your proxy card, or (3) signing and returning all proxy cards that you receive in the postage-paid envelope provided, so that your shares may be represented and voted at the Apexigen special meeting.

In connection with the execution of the Merger Agreement, Pyxis Oncology entered into voting agreements with each of Apexigen’s directors and officers and an Apexigen stockholder holding greater than 5% of the outstanding shares of Apexigen common stock (in each case, solely in their respective capacities as Apexigen stockholders), collectively owning approximately 10.6% of the outstanding shares of Apexigen common stock as of May 19, 2023, pursuant to which they have agreed, among other things, to vote all of the shares of Apexigen common stock beneficially owned by them in favor of the Apexigen merger proposal and the Apexigen adjournment proposal.

The Apexigen board of directors recommends that Apexigen stockholders vote “FOR” the Apexigen merger proposal and, if necessary, “FOR” the Apexigen adjournment proposal.

The obligations of Pyxis Oncology and Apexigen to complete the Merger are subject to the satisfaction or waiver of several conditions set forth in the Merger Agreement. More information about Pyxis Oncology, Apexigen and the Merger is contained in this proxy statement/prospectus. You are encouraged to read this entire proxy statement/prospectus carefully, including the section entitled “Risk Factors” beginning on page 35.

We look forward to the successful Merger of Pyxis Oncology and Apexigen.

	Sincerely,
	Xiaodong Yang, M.D., Ph.D.
	Chief Executive Officer and Director
	Apexigen, Inc.

NEITHER THE U.S. SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVED OR DISAPPROVED OF THE SECURITIES TO BE ISSUED UNDER THIS PROXY STATEMENT/PROSPECTUS OR DETERMINED THAT THIS PROXY STATEMENT/PROSPECTUS IS ACCURATE OR COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.

This proxy statement/prospectus is dated           , 2023 and is first being mailed to Apexigen stockholders on or about          , 2023.

Apexigen, Inc.

900 Industrial Road, Suite C

San Carlos, CA 94070

(650) 931-6236

NOTICE OF SPECIAL MEETING OF STOCKHOLDERS

TO BE HELD ON          , 2023

Virtual Meeting Only – No Physical Meeting Location

Dear Apexigen Stockholders:

We are pleased to invite you to attend the special meeting of Apexigen stockholders, which will be held on          , 2023, at          (Pacific Time) (the “Apexigen special meeting”). The Apexigen special meeting will be conducted via live webcast at www.proxydocs.com/APGN for the following purposes:

Apexigen will transact no other business at the Apexigen special meeting except such business as may properly be brought before the Apexigen special meeting or any adjournment or postponement thereof. Please refer to the attached proxy statement/prospectus for further information with respect to the business to be transacted at the Apexigen special meeting.

In order to virtually attend the Apexigen special meeting, as well as vote and submit your questions during the live webcast of the meeting, you will need to register at www.proxydocs.com/APGN. Upon entry of your control number and other required information, you will receive further instruction via email, that provides you access to the Apexigen special meeting, and allows you to vote and submit questions during the Apexigen special meeting. Please be sure to follow the instructions found on your proxy card and/or voting authorization form.

At a meeting of the Apexigen board of directors (the “Apexigen Board”) held on May 23, 2023, the Apexigen Board (1) determined that the Merger Agreement and the transactions contemplated thereby, including the Merger, are advisable, fair to and in the best interests of Apexigen and its stockholders; (2) approved the execution and delivery of the Merger Agreement by Apexigen, the performance by Apexigen of its covenants and other obligations thereunder, and the consummation of the Merger upon the terms and subject to the conditions set forth therein; (3) recommended that the stockholders of Apexigen adopt the Merger Agreement and approve the transactions contemplated thereby; and (4) directed that the adoption of the Merger Agreement be submitted for consideration by the stockholders of Apexigen at a meeting thereof.

The Apexigen Board recommends that Apexigen stockholders vote “FOR” the Apexigen merger proposal and, if necessary, “FOR” the Apexigen adjournment proposal.

Holders of record of shares of Apexigen common stock, at the close of business on          , 2023 (the “Apexigen record date”), are entitled to notice of, and may vote at, the Apexigen special meeting and any adjournment of the Apexigen special meeting. A list of Apexigen stockholders entitled to vote at the Apexigen special meeting will be available for inspection at Apexigen’s principal place of business, located at 900 Industrial Road, Suite C, San Carlos, CA 94070, at least 10 days prior to the date of the Apexigen special meeting and continuing through the date thereof for any purpose germane to the Apexigen special meeting, between the hours of 9:00 a.m. and 4:30 p.m., Pacific Time.

Approval of the Apexigen merger proposal requires the affirmative vote of Apexigen stockholders representing a majority of the outstanding shares of Apexigen common stock entitled to vote thereon. Approval of the Apexigen adjournment proposal requires the affirmative vote of Apexigen stockholders representing a majority of the voting power of the shares of Apexigen common stock present in person or represented by proxy and entitled to vote thereon.

Your vote is important. Whether or not you expect to virtually attend the Apexigen special meeting, you are urged to vote your shares as promptly as possible by (1) accessing the Internet website specified on your proxy card; (2) calling the toll-free number specified on your proxy card; or (3) signing and returning the enclosed proxy card in the postage-paid envelope provided, so that your shares may be represented and voted at the Apexigen special meeting. If your shares are held in street name through a bank, broker or other nominee, please follow the instructions on the voting instruction card furnished to you by the record holder. Your bank, broker or other nominee may have an earlier deadline by which you must provide instructions as to how to vote your shares of Apexigen common stock, so you should read carefully the materials provided to you by your bank, broker or other nominee. If your shares are registered directly in your name with Apexigen’s transfer agent, Continental Stock Transfer & Trust Company, you are considered, with respect to those shares, to be the shareholder of record. In such case, these proxy materials are being sent directly to you.

If you have any questions or need assistance voting your shares, please call Apexigen’s proxy solicitor, MacKenzie Partners, Inc., toll-free at (800) 322-2885. 

	By Order of the Apexigen Board,
	Xiaodong Yang, M.D., Ph.D.
	Chief Executive Officer and Director
	Apexigen, Inc.

We are pleased to invite you to virtually attend the Apexigen special meeting, conducted via live webcast, at www.proxydocs.com/APGN. You will not be able to attend the special meeting in person. Whether or not you expect to attend the Apexigen special meeting, please complete, date, sign and return the proxy card that may be delivered to you or vote over the telephone or the Internet as instructed in these materials, as promptly as possible in order to ensure your representation at the Apexigen special meeting. Even if you have voted by proxy, you may still vote if you attend the Apexigen special meeting. Please note, however, that if your shares are held of record by a bank, broker or other nominee and you wish to vote at the Apexigen special meeting, you may be instructed to obtain a legal proxy form from your bank, broker or other nominee and to submit a copy in advance of the Apexigen special meeting.

ABOUT THIS PROXY STATEMENT/PROSPECTUS

This document, which forms part of a registration statement on Form S-4 filed with the SEC (as defined herein) by Pyxis Oncology (File No. 333-        ), constitutes a prospectus of Pyxis Oncology under Section 5 of the Securities Act (as defined herein), with respect to the shares of Pyxis Oncology common stock to be issued to Apexigen stockholders pursuant to the Merger Agreement. This document also constitutes a notice of meeting and proxy statement of Apexigen under Section 14(a) of the Exchange Act (as defined herein).

Pyxis Oncology has supplied all information contained in this proxy statement/prospectus relating to Pyxis Oncology and Merger Sub. Apexigen has supplied all information contained in this proxy statement/prospectus relating to Apexigen. Pyxis Oncology and Apexigen have both contributed information relating to the Merger.

You should rely only on the information contained in or incorporated by reference into this proxy statement/prospectus. No one has been authorized to provide you with information that is different from that contained in or incorporated by reference into this proxy statement/prospectus. For additional information on the documents incorporated by reference in this proxy statement/prospectus, see the sections entitled “Where You Can Find More Information” and “Incorporation of Certain Information by Reference.” This proxy statement/prospectus is dated           , 2023, and is based on information as of that date or such other date as may be noted. You should not assume that the information contained in this proxy statement/prospectus is accurate as of any other date. You should not assume that the information contained in any document incorporated or deemed to be incorporated by reference herein is accurate as of any date other than the date of such document. Any statement contained in a document incorporated or deemed to be incorporated by reference into this proxy statement/prospectus will be deemed to be modified or superseded to the extent that a statement contained herein or in any other subsequently filed document which also is or is deemed to be incorporated by reference into this proxy statement/prospectus modifies or supersedes that statement. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to constitute a part of this proxy statement/prospectus. Neither the mailing of this proxy statement/prospectus to the Apexigen stockholders nor the taking of any actions contemplated hereby by Pyxis Oncology or Apexigen at any time will create any implication to the contrary.

DEFINED TERMS

Unless otherwise indicated or as the context otherwise requires, all references in this proxy statement/prospectus to:

REFERENCES TO ADDITIONAL INFORMATION

This proxy statement/prospectus incorporates by reference important business and financial information about Pyxis Oncology from documents Pyxis Oncology has filed or will file with the SEC that are not included in or delivered with this proxy statement/prospectus. For additional information on the documents incorporated by reference in this proxy statement/prospectus, see the sections entitled “Where You Can Find More Information” and “Incorporation of Certain Information by Reference.”  This information is available to you without charge upon your written or oral request. You can obtain documents incorporated by reference in this proxy statement/prospectus by requesting them in writing or by telephone using the following contact information, or free of charge on the SEC website, www.sec.gov.

Pyxis Oncology

321 Harrison Avenue
Boston, MA 02118
(617) 221-9059
Attn: Investor Relations

In addition, if you have questions about the Merger or this proxy statement/prospectus, would like additional copies of the proxy statement/prospectus, or need to obtain proxy cards or other information related to the proxy solicitation, please contact MacKenzie Partners, Inc., the proxy solicitor for Apexigen, by telephone toll-free at (800) 322-2885 or by email at proxy@mackenziepartners.com. You will not be charged for any of these documents that you request.

You may also request a copy of this proxy statement/prospectus or other information concerning Pyxis Oncology, without charge, by written or telephonic request directed to Pyxis Oncology, 321 Harrison Avenue, Boston MA 02119, Telephone: (617) 221-9059; or from the SEC through its website mentioned above.

If you would like to request any documents, please do so no later than          , 2023, or the date that is five business days before the date of the Apexigen special meeting, in order to receive timely delivery of such documents before the Apexigen special meeting.

TABLE OF CONTENTS

QUESTIONS AND ANSWERS

The following are brief answers to certain questions that Apexigen stockholders may have regarding the Merger, the Merger Agreement, the issuance of shares of Pyxis Oncology common stock in connection with the Merger, the Apexigen special meeting, and other matters to be considered at the Apexigen special meeting. Apexigen urges you to carefully read the remainder of this proxy statement/prospectus and additional important information contained in the annexes and exhibits to, and the documents incorporated by reference into, this proxy statement/prospectus because the information in this section may not provide all of the information that might be important to you in determining how to vote. See the section entitled “Where You Can Find More Information” for more information.

Under the terms of the Merger Agreement, Merger Sub will merge with and into Apexigen, with Apexigen continuing as a wholly owned subsidiary of Pyxis Oncology. If the Merger is completed, holders of Apexigen stockholders will have the right to receive, for each share of Apexigen common stock issued and outstanding immediately prior to the Closing Date (other than certain excluded shares specified in the Merger Agreement) held by such stockholder, 0.1725 shares of Pyxis Oncology common stock (the “Exchange Ratio”). No fractional shares of Pyxis Oncology common stock will be issued in connection with the Merger and the number of shares of Pyxis Oncology common stock to be issued to Apexigen stockholders shall be rounded down to the nearest whole share. The Exchange Ratio is fixed, and will not reflect changes in the market price of either Apexigen common stock or Pyxis Oncology common stock. Upon completion of the Merger and based on         shares of Pyxis Oncology common stock and         shares of Apexigen common stock outstanding as of        , 2023, it is expected that Pyxis Oncology stockholders and certain other equity holders will own approximately 90% of the outstanding common stock of the combined company and Apexigen stockholders and certain other equityholders will own approximately 10% of the outstanding common stock of the combined company, in each case, on a fully diluted basis.

Apexigen is holding a special meeting of stockholders to obtain the Stockholders’ Approval necessary to approve the Apexigen merger proposal. In addition, Apexigen stockholders will also be asked to approve the adjournment from time to time of the Apexigen special meeting, if necessary to solicit additional proxies if there are insufficient shares of Apexigen common stock present or represented by proxy at the Apexigen special meeting to constitute a quorum at the Apexigen special meeting or any adjournment or postponement thereof. It is important that Apexigen stockholders vote their Apexigen common stock on each of these matters, regardless of the number of shares owned.

Your vote is important. You are encouraged to vote as soon as possible.

Pyxis Oncology stockholders will continue to own their existing shares of Pyxis Oncology common stock. Pyxis Oncology common stock is currently traded on the Nasdaq under the symbol “PYXS,” and Apexigen common stock is currently traded on the Nasdaq under the symbol “APGN.” You are encouraged to obtain current market quotations of Pyxis Oncology common stock and Apexigen common stock before voting.

Beneficial Owner: Shares Registered in the Name of Broker or Bank

If you are a beneficial owner of shares registered in the name of your brokerage firm, bank or other agent, you should have received a voting instruction form with the proxy card delivered to you from that organization rather than from Apexigen. Simply complete and mail the voting instruction form to ensure that your vote is counted. Alternatively, you may vote by telephone or over the Internet as instructed by your broker, bank or other agent. To vote at the Apexigen special meeting, you will need to visit www.proxydocs.com/APGN and register to attend. You may be instructed to obtain a legal proxy from your broker, bank or other nominee and to submit a copy in advance of the Apexigen special meeting. Further instruction will be provided to you as part of your registration process.

Internet proxy voting may be provided to allow you to vote your shares online, with procedures designed to ensure the authenticity and correctness of your proxy vote instructions. However, please be aware that you must bear any costs associated with your Internet access, such as usage charges from Internet access providers and telephone companies.

Apexigen adjournment proposal. Approval of the Apexigen adjournment proposal requires the affirmative vote of Apexigen stockholders representing a majority of the voting power of the shares of Apexigen common stock present in person or represented by proxy and entitled to vote thereon. For the Apexigen adjournment proposal, abstentions will have the same effect as a vote against the proposal, and broker non-votes will have no effect on the outcome of the proposal. Shares of Apexigen common stock represented by properly executed, timely received and unrevoked proxies will be voted in accordance with the instructions indicated thereon.

In connection with the execution of the Merger Agreement, Pyxis Oncology entered into voting agreements with each of Apexigen’s directors and officers and an Apexigen stockholder holding greater than 5% of the outstanding shares of Apexigen common stock (in each case, solely in their respective capacities as Apexigen stockholders, the “Apexigen Supporting Holders”), collectively owning approximately 10.6% of the outstanding shares of Apexigen common stock as of May 19, 2023, pursuant to which they have agreed, among other things, to vote all of the shares of Apexigen common stock beneficially owned by them in favor of the Apexigen merger proposal and the Apexigen adjournment proposal.

Please follow the voting instructions provided by your broker or nominee. Please note that you may not vote shares held in street name by returning a proxy card directly to Apexigen or by voting at your special meeting. Further, brokers who hold shares of Apexigen common stock on behalf of their customers may not give a proxy to Apexigen to vote those shares without specific instructions from their customers.

If you choose either of the first two methods, you must provide your notice of revocation or your new proxy to the secretary of Apexigen prior to your shares being voted. If your shares are held in street name by your broker or nominee, you should contact them to change your vote.

Treatment of Restricted Stock Unit Awards. Each award of restricted stock units of Apexigen (each, an “Apexigen RSU Award”) outstanding as of immediately prior to the Effective Time will be assumed and converted as of the Effective Time into an award of Pyxis restricted stock units, with substantially similar terms and conditions as were applicable under such Apexigen RSU Award, that covers the number of shares of Pyxis Oncology common stock determined by multiplying the number of shares of Apexigen common stock subject to such Apexigen RSU Award immediately prior to the Effective Time by the Exchange Ratio (rounded down to the nearest whole share).

Treatment of Warrants. Each warrant to purchase shares of Apexigen common stock (each, an “Apexigen Warrant”) outstanding immediately prior to the Effective Time will be assumed and converted as of the Effective Time into a warrant to acquire, on substantially similar terms and conditions as were applicable under such Apexigen Warrant, a number of shares of Pyxis Oncology common stock determined by multiplying the number of shares of Apexigen common stock subject to such Apexigen Warrant immediately prior to the Effective Time by the Exchange Ratio (rounded down to the nearest whole share), with an exercise price per share equal to the exercise price per share of such Apexigen Warrant as of immediately prior to the Effective Time, divided by the Exchange Ratio (rounded up to the nearest whole cent), with any fractional shares to be dealt with in accordance with the terms of such Apexigen Warrant.

The rights of Pyxis Oncology stockholders will remain the same as prior to the Merger.

The tax consequences of the transactions to each Apexigen stockholder may depend on such holder’s particular facts and circumstances. Apexigen stockholders are urged to consult their tax advisors to understand fully the consequences to them of the transactions in their specific circumstances. For more information, see “Material U.S. Federal Income Tax Consequences.”

If you are a Pyxis Oncology stockholder, you are not required to take any action with respect to your Pyxis stock certificates.

Under Delaware law, the Pyxis Oncology stockholders are not entitled to appraisal rights in connection with the issuance of shares of Pyxis Oncology common stock in the Merger pursuant to the terms of the Merger Agreement.

COMPARATIVE MARKET PRICE INFORMATION

Pyxis Oncology common stock is listed on Nasdaq under the symbol “PYXS.” Apexigen common stock is listed on Nasdaq under the symbol “APGN.” The following table presents the closing prices of Pyxis Oncology common stock and Apexigen common stock on May 23, 2023, the last practicable trading day before the public announcement of the Merger Agreement, and         , 2023, the last practicable trading day prior to the mailing of this proxy statement/prospectus. The table also shows the equivalent per share value of the Merger Consideration for a share of Apexigen common stock on the relevant date. Equivalent per share amounts for Apexigen common stock are calculated by multiplying per share information for Pyxis Oncology common stock by the Exchange Ratio, rounded down to the nearest whole cent.

The above table shows only historical comparisons. These comparisons may not provide meaningful information to Apexigen stockholders in determining whether to approve the adoption of the Merger Agreement. Because the Exchange Ratio will not be adjusted for changes in the market price of Pyxis Oncology common stock, the market value of the shares of Pyxis Oncology common stock that holders of Apexigen common stock will be entitled to receive at the Effective Time of the Merger may vary significantly from the market value of the shares of Pyxis Oncology common stock that holders of Apexigen common stock would have received if the Merger were completed on the dates shown in the table above.

RISK FACTORS

The combined company will be faced with a market environment that cannot be predicted and that involves significant risks, many of which will be beyond its control. In addition to the other information contained in this proxy statement/prospectus, including the matters addressed in the section entitled “Forward-Looking Statements,” you should carefully consider the risks described below before deciding how to vote on the proposals presented in this proxy statement/prospectus. You should also read and consider the risks associated with each of the businesses of Pyxis Oncology and Apexigen because these risks will also affect the combined company. Certain risk factors related to the business of Pyxis Oncology are contained in the documents that are incorporated by reference into this proxy statement/prospectus. The risk factors described below and incorporated by reference into this proxy statement/prospectus disclose both material and other risks, are not intended to be exhaustive and are not the only risks facing Pyxis Oncology and Apexigen or the combined company following the Merger. Additional risks not currently known to Pyxis Oncology or Apexigen, or that they currently deem to be immaterial may also materially adversely affect their respective businesses, financial condition, results of operations and cash flows in future periods or are not identified because they are generally common to businesses.

Risks Relating to the Merger

The failure to complete the Merger in a timely manner, or at all, may adversely affect the business and financial results of Pyxis Oncology and Apexigen and their respective stock prices.

Each of Pyxis Oncology’s and Apexigen’s obligations to consummate the Merger are subject to the satisfaction or waiver of certain conditions, including, among other things, (1) adoption of the Merger Agreement by Apexigen’s stockholders, (2) the absence of any order or legal restraint that prevents the consummation of the Merger, and (3) the approval for listing of the shares of Pyxis Oncology common stock to be issued in connection with the Merger on the Nasdaq and the effectiveness of a registration statement with respect to such Pyxis Oncology common stock. Each party’s obligation to consummate the Merger is also subject to other specified customary conditions, including the representations and warranties of the other party being true and correct as of the date of the Merger Agreement and as of the Closing Date, generally subject to an overall material adverse effect qualification, and the performance in all material respects by the other party of its obligations under the Merger Agreement required to be performed on or prior to the date of the closing of the Merger.

The Exchange Ratio is fixed and will not be adjusted in the event of any change in the stock prices of either Pyxis Oncology or Apexigen.

Upon closing of the Merger, each share of Apexigen common stock will be converted into the right to receive the Exchange Ratio of 0.1725 of a share of Pyxis Oncology common stock. This Exchange Ratio is fixed in the Merger Agreement and will not be adjusted for changes in the market price of either Pyxis Oncology common stock or Apexigen common stock. Because the Exchange Ratio will not be adjusted for changes in the market price of Pyxis Oncology common stock, the market value of the shares of Pyxis Oncology common stock that holders of Apexigen common stock will be entitled to receive at the Effective Time may vary significantly from the market value of the shares of Pyxis Oncology common stock that holders of Apexigen common stock would have received if the Merger had been completed on any other date, including the date of the Merger Agreement. In addition, Pyxis Oncology will issue a number of shares of Pyxis Oncology common stock in connection with the Merger based on the number of shares of Apexigen common stock outstanding as of the Effective Time, which may result in fluctuations in the market price of Pyxis Oncology common stock, including a stock price decline. The amount of shares of Pyxis Oncology common stock issued in connection with the Merger will not change based on the price of the shares of Pyxis Oncology common stock or Apexigen common stock as of the Effective Time or their relative price.

The Merger Agreement does not provide for any termination right by either Pyxis Oncology or Apexigen solely based on changes in the price or trading volume of Pyxis Oncology common stock or Apexigen common stock.

Because the Merger will be completed after the date of the Apexigen special meeting, at the time of the Apexigen special meeting, you will not know the exact market value of the Pyxis Oncology common stock that Apexigen stockholders and certain other Apexigen equityholders will receive upon completion of the Merger.

Uncertainty about the Merger may adversely affect the respective business and stock price of Pyxis Oncology and Apexigen, whether or not the Merger is completed.

Each of Pyxis Oncology and Apexigen are subject to risks in connection with the announcement and pendency of the Merger, including the pendency and outcome of any legal proceedings against Pyxis Oncology and Apexigen, their respective directors and others relating to the Merger and the risks from possibly foregoing opportunities Pyxis Oncology and Apexigen might otherwise pursue absent the proposed Merger. Furthermore, uncertainties about the Merger may cause current and prospective employees of Pyxis Oncology and Apexigen to experience uncertainty about their future with their respective companies. These uncertainties may impair Pyxis Oncology’s and Apexigen’s ability to retain, recruit or motivate key management and other personnel.

In addition, in response to the announcement of the proposed Merger, Pyxis Oncology’s and Apexigen’s existing or prospective suppliers or collaboration partners may:

While Pyxis Oncology and Apexigen are attempting to address these risks, their respective existing and prospective customers, suppliers or collaboration partners may be reluctant to purchase Pyxis Oncology’s and Apexigen’s products, supply Pyxis Oncology and Apexigen with goods and services or continue collaborations due to the potential uncertainty about the direction of Pyxis Oncology’s and Apexigen product offerings and the support and service of Pyxis Oncology’s and Apexigen’s products after the completion of the Merger.

While the Merger is pending, Apexigen is subject to contractual restrictions that could harm its business, operating results and stock price.

The Merger Agreement includes restrictions on the conduct of Apexigen’s business prior to the completion of the Merger, generally requiring Apexigen to conduct its businesses in the ordinary course, consistent with past practice, and restricting Apexigen from taking certain specified actions absent Pyxis Oncology’s prior written consent. See the section entitled “The Merger Agreement—Conduct of Business Pending the Merger” in this proxy statement/prospectus. Apexigen may find that these and other obligations in the Merger Agreement may delay or prevent Apexigen from or limit its ability to respond effectively to competitive pressures, industry developments and future business opportunities that may arise during such period, even if Apexigen’s management and the Apexigen Board think they may be advisable. These restrictions could adversely impact Apexigen’s business, operating results and stock price and its perceived acquisition value, regardless of whether the Merger is completed.

The Merger Agreement limits Apexigen’s ability to pursue alternative transactions which could deter a third party from proposing an alternative transaction.

The Merger Agreement contains provisions that, subject to certain exceptions, limit, among other things, Apexigen’s ability to participate in any negotiations or discussions regarding, or, knowingly, with the intention to encourage or facilitate, furnish any nonpublic information in response to inquiries with respect to an alternative transaction. See the section entitled “The Merger Agreement—No Solicitation of Acquisition Proposals and Change of Recommendation” in this proxy statement/prospectus. It is possible that these or other provisions in the Merger Agreement might discourage a potential competing acquirer that might have an interest in acquiring all or a significant part of the outstanding shares of Apexigen common stock from considering or proposing an acquisition or might result in a potential competing acquirer proposing to pay a lower per share price to acquire Apexigen common stock than it might otherwise have proposed to pay.

The Merger will involve substantial costs.

Pyxis Oncology and Apexigen have incurred and expect to continue to incur substantial costs and expenses relating to the Merger and the issuance of Pyxis Oncology common stock in connection with the Merger, including, as applicable, fees and expenses payable to financial advisors, other professional fees and expenses, insurance premium costs, SEC filing fees, printing and mailing costs and other transaction-related costs, fees and expenses. Pyxis Oncology also will incur significant transaction fees and costs in connection with its formulating and implementing integration plans with respect to the two companies. Pyxis Oncology continues to assess the magnitude of these costs, and additional unanticipated costs may be incurred in connection with the Merger and the integration of the two companies’ businesses. In addition, if the Merger is not completed, Pyxis Oncology and Apexigen will have incurred substantial expenses for which no ultimate benefit will have been received by either company.

The fairness opinion obtained by the Apexigen Board from its financial advisor will not be updated to reflect changes in circumstances between signing the Merger Agreement and the completion of the Merger.

The Apexigen Board has not obtained an updated fairness opinion as of the date of this proxy statement/prospectus from Ladenburg, its financial advisor. Changes in the operations and prospects of Pyxis Oncology or Apexigen, general market and economic conditions, and other factors that may be beyond the control of Pyxis Oncology and Apexigen and on which the fairness opinion was based, may alter the value of Pyxis Oncology or Apexigen or the price of Pyxis Oncology common stock or Apexigen common stock by the time the Merger is completed.

The fairness opinion does not speak as of the time the Merger will be completed or as of any date other than the date of such opinion. Apexigen does not anticipate asking Ladenburg to update its fairness opinion. The fairness opinion of Ladenburg is included as Annex C to this proxy statement/prospectus. For a description of the fairness opinion that the Apexigen Board received from Ladenburg and a summary of the material financial analyses it provided to the Apexigen Board in connection with rendering such opinion, see the section entitled “The Merger—Opinion of Apexigen’s Financial Advisor” in this proxy statement/prospectus.

For a description of the factors considered by the Apexigen Board in determining to approve the Merger, see the section entitled “The Merger—Apexigen’s Reasons for the Merger; Recommendation of the Apexigen Board” in this proxy statement/prospectus.

Certain directors and executive officers of Apexigen may have interests in the Merger that are or were different from, or in conflict with or in addition to, those of Apexigen’s stockholders generally.

In considering whether to approve the proposals at the Apexigen special meeting, Apexigen stockholders should recognize that directors and officers of Apexigen have interests in the Merger that may differ from, or that are in addition to, their interests as stockholders of Apexigen. The Apexigen Board was aware of these interests at the time it approved the Merger Agreement. These interests may cause Apexigen’s directors and officers to view the Merger differently from how you may view it as a stockholder. For a description of the factors considered by the Apexigen Board in determining to approve the Merger, see the section entitled “The Merger—Financial Interests of Apexigen’s Directors and Executive Officers in the Merger” in this proxy statement/prospectus.

As of the Apexigen record date, Apexigen’s directors, executive officers, and their respective affiliates, as a group, beneficially held and were entitled to vote        shares of Apexigen common stock, representing        % of the voting power of the outstanding shares of Apexigen common stock. Apexigen’s directors and executive officers have agreed, pursuant to their respective Voting Agreements with Pyxis Oncology, to vote all of their respective shares of Apexigen common stock “FOR” the Apexigen merger proposal and “FOR” the Apexigen adjournment proposal.

Holders of Apexigen common stock will not be entitled to appraisal rights in the Merger.

Appraisal rights are statutory rights that, if applicable under law, enable stockholders to dissent from an extraordinary transaction, such as a merger, and to demand that the corporation pay the fair value for their shares as determined by a court in a judicial proceeding instead of receiving the consideration offered to shareholders in connection with the extraordinary transaction.

Under Section 262(b) of the DGCL, stockholders do not have appraisal rights if the shares of stock they hold, as of the record date for determination of stockholders entitled to vote at the meeting of shareholders to act upon a merger, are either (i) listed on a national securities exchange or (ii) held of record by more than 2,000 holders, unless the stockholders are required by the terms of the merger agreement to receive in exchange for their shares in the merger anything other than shares of stock of the surviving or resulting corporation (or depositary receipts in respect thereof), or of any other corporation that is publicly listed or held by more than 2,000 holders of record, cash in lieu of fractional shares or fractional depositary receipts described above or any combination of the foregoing. Because Apexigen stockholders will receive only shares of Pyxis Oncology common stock which will be listed on the Nasdaq and cash in lieu of any fractional shares, Apexigen stockholders will not have any appraisal rights. See the section entitled “The Merger—Appraisal Rights” in this proxy statement/prospectus.

Pyxis Oncology or Apexigen may waive one or more of the closing conditions to the Merger without re-soliciting the Stockholders’ Approval from Apexigen stockholders.

To the extent permitted by law, Pyxis Oncology or Apexigen may determine to waive, in whole or part, one or more of the conditions to their respective obligations to consummate the Merger. Apexigen expects to evaluate the materiality of any waiver and its effect on Apexigen stockholders in light of the facts and circumstances at the time to determine whether any amendment of this proxy statement/prospectus or any re-solicitation of proxies is required in light of such waiver. Any determination as to whether to waive any condition to the consummation of the Merger, and as to whether to re-solicit the Stockholders’ Approval and/or amend this proxy statement/prospectus as a result of such waiver, will be made by Pyxis Oncology and Apexigen at the time of such waiver based on the facts and circumstances as they exist at that time.

After the Merger, Apexigen stockholders will have a significantly lower ownership and voting interest in Pyxis Oncology than they currently have in Apexigen and will exercise less influence over management and policies of the combined company.

Upon completion of the Merger and based on         shares of Pyxis Oncology common stock and         shares of Apexigen common stock outstanding as of         , 2023, it is expected that Pyxis Oncology stockholders and certain other equity holders will own approximately 90% of the outstanding common stock of the combined company and Apexigen stockholders and certain other equityholders will own approximately 10% of the outstanding common stock of the combined company, in each case, on a fully diluted basis. Consequently, former Apexigen stockholders will have less influence over the management and policies of the combined company than they currently have over the management and policies of Apexigen.

Apexigen and Pyxis Oncology may be targets of securities class action and derivative lawsuits which could result in substantial costs and may delay or prevent the Merger from being completed.

Securities class action lawsuits and derivative lawsuits are often brought against public companies that have entered into merger agreements. Even if the lawsuits are without merit, defending against these claims could result in substantial costs and divert management time and resources. An adverse judgment could result in monetary damages, which could have a negative impact on Pyxis Oncology’s and Apexigen’s respective liquidity and financial condition. Additionally, if a plaintiff is successful in obtaining an injunction prohibiting completion of the Merger, then that injunction may delay or prevent the Merger from being completed, or from being completed within the expected timeframe, which may adversely affect Pyxis Oncology’s and Apexigen’s respective business, financial position and results of operations.

Risks Related to Pyxis Oncology Following the Merger

Pyxis Oncology may fail to realize the benefits and synergies expected from the Merger, which could adversely affect its stock price.

The anticipated benefits and synergies Pyxis Oncology expects from the Merger are, necessarily, based on projections and assumptions about the combined businesses of Pyxis Oncology and Apexigen, which may not materialize as expected or which may prove to be inaccurate. The value of Pyxis Oncology common stock following the completion of the Merger could be adversely affected if Pyxis Oncology is unable to realize the anticipated benefits and synergies from the Merger on a timely basis or at all.

Pyxis Oncology cannot predict with certainty if or when any benefits and synergies from the Merger will be realized, or the extent to which they will actually be achieved. Realization of any benefits or synergies could be affected by the factors described in other risk factors contained in or incorporated by reference into this proxy statement/prospectus and a number of factors beyond Pyxis Oncology’s control, including, without limitation, general economic conditions, increased operating costs and regulatory developments.

Pyxis Oncology may be unable to appropriately integrate the business, operations and assets of Apexigen into its existing business.

Achieving the benefits of the Merger will depend, in part, on Pyxis Oncology’s ability to integrate the business, operations and assets of Apexigen successfully and efficiently with its business. The challenges involved in this integration, which will be complex and time-consuming, include the following:

If Pyxis Oncology does not successfully manage these issues and the other challenges inherent in integrating an acquired business of the size and complexity of Apexigen, then Pyxis Oncology may not achieve the anticipated benefits of the Merger and its revenue, expenses, operating results and financial condition could be materially adversely affected.

The acquisition of Apexigen may result in significant charges or other liabilities that could adversely affect the financial results of the combined company.

The financial results of the combined company may be adversely affected by cash expenses and non-cash accounting charges incurred in connection with Pyxis Oncology’s integration of the business and operations of Apexigen. The amount and timing of these possible charges are not yet known. Further, Pyxis Oncology’s failure to identify or accurately assess the magnitude of certain liabilities it is assuming in the Merger could result in unexpected litigation or regulatory exposure, unfavorable accounting charges, unexpected increases in taxes due, a loss of anticipated tax benefits or other adverse effects on Pyxis Oncology’s business, operating results or financial condition. The price of Pyxis Oncology common stock following the Merger could decline to the extent the combined company’s financial results are materially affected by any of these events.

The unaudited pro forma condensed combined financial information for Pyxis Oncology included in this proxy statement/prospectus is preliminary, and the actual financial position and operations of Pyxis Oncology after the Merger may differ materially from the unaudited pro forma condensed combined financial information included in this proxy statement/prospectus.

The unaudited pro forma condensed combined financial information for Pyxis Oncology included in this proxy statement/prospectus is presented for illustrative purposes only and is based on assumptions and estimates considered appropriate by Pyxis Oncology’s management; however, it does not necessarily reflect what the combined company’s financial condition or results of operations would have been had the Merger been completed on the dates assumed. Pyxis Oncology’s actual results and financial position after the Merger may differ materially and adversely from the unaudited pro forma condensed combined financial information included in this proxy statement/prospectus. The unaudited pro forma condensed combined financial information reflects adjustments, which are preliminary and may be revised. The unaudited pro forma condensed combined financial information does not consider any impacts of integration costs, anticipated cost savings and expense efficiencies, or other synergies that may result from the Merger or any strategies that management may consider in order to continue to efficiently manage Apexigen’s operations. The purchase price allocation reflected in this document is preliminary, and final allocation of the purchase price will be based upon the actual purchase price and the fair value of the assets and liabilities of Apexigen as of the date of the completion of the Merger. For more information see the section entitled “Unaudited Pro Forma Condensed Combined Financial Information” in this proxy statement/prospectus.

Pyxis Oncology’s future results will suffer if it does not effectively manage its expanded operations following the Merger.

Following the Merger, the size and scope of operations of the business of the combined company will increase beyond the current size and scope of operations of either Pyxis Oncology’s or Apexigen’s current businesses. In addition, Pyxis Oncology may continue to expand its size and operations through additional acquisitions or other strategic transactions. Pyxis Oncology’s future success depends, in part, upon its ability to manage its expanded business, which may pose substantial challenges for its management, including challenges related to the management and monitoring of new operations and locations and associated increased costs and complexity. There can be no assurances that Pyxis Oncology will be successful in managing such expanded business or that it will realize the expected economies of scale, synergies and other benefits currently anticipated from the Merger or anticipated from any additional acquisitions or strategic transactions.

The market price of Pyxis Oncology common stock after completion of the Merger will continue to fluctuate, and may be affected by factors different from those affecting shares of Apexigen common stock currently.

Upon completion of the Merger, holders of Apexigen common stock will become holders of Pyxis Oncology common stock. The business of Pyxis Oncology differs from that of Apexigen in important respects, and, accordingly, the results of operations of Pyxis Oncology after the Merger, as well as the market price of Pyxis Oncology common stock, may be affected by factors different from those currently affecting the results of operations of Apexigen. As a result of the Merger, Apexigen will be part of a larger company with other lines of business, such that decisions affecting Apexigen may be made in respect of the larger combined business as a whole rather than the Apexigen business individually. Moreover, general fluctuations in stock markets could have a material adverse effect on the market for, or liquidity of, Pyxis Oncology common stock, regardless of Pyxis Oncology’s actual operating performance. For further information on the businesses of Pyxis Oncology and Apexigen and certain factors to consider in connection with those businesses, see the documents incorporated by reference into or included in this proxy statement/prospectus and referred to under the sections entitled “Where You Can Find More Information” and “Incorporation of Certain Information by Reference” in this proxy statement/prospectus.

The combined company may not be able to retain suppliers or distributors, or suppliers or distributors may seek to modify contractual relationships with the combined company, which could have an adverse effect on the combined company’s business and operations. Third parties may terminate or alter existing contracts or relationships with Pyxis Oncology or Apexigen.

As a result of the Merger, the combined company may experience impacts on relationships with customers, suppliers and distributors that may harm the combined company’s business and results of operations. Certain suppliers or distributors may seek to terminate or modify contractual obligations following the Merger whether or not contractual rights are triggered as a result of the Merger. There can be no guarantee that customers, suppliers and distributors will remain with or continue to have a relationship with the combined company or do so on contractual terms amenable to Pyxis Oncology following the Merger. If any suppliers or distributors seek to terminate or modify contractual obligations or discontinue their relationship with the combined company, then the combined company’s business and results of operations may be harmed. Furthermore, the combined company will not have long-term arrangements with many of its significant suppliers. If the combined company’s suppliers were to seek to terminate or modify an arrangement with the combined company, then the combined company may be unable to procure necessary supplies from other suppliers in a timely and efficient manner and on acceptable terms, or at all.

Apexigen (or certain of its subsidiaries) also has contracts with vendors, landlords and other business partners which may require Apexigen (or certain of its subsidiaries) to obtain consent from or provide notice to these other parties in connection with the Merger, or which may otherwise contain limitations applicable to such contracts following the Merger. If these consents cannot be obtained, the combined company may suffer a loss of potential future revenue, incur costs and lose rights that may be material to the combined company’s business. In addition, third parties with whom Pyxis Oncology and Apexigen currently have relationships may terminate or otherwise reduce the scope of their relationship with either party in anticipation of the Merger. Any such disruptions could limit the combined company’s ability to achieve the anticipated benefits of the Merger. The adverse effect of any such disruptions could also be exacerbated by a delay in the completion of the Merger or by a termination of the Merger Agreement.

Additional Risks Related to Pyxis Oncology

Pyxis Oncology’s business is and will be subject to the risks described above. In addition, Pyxis Oncology is also currently subject to the additional risks described in Pyxis Oncology’s Annual Report on Form 10-K for the year ended December 31, 2022, as updated by any subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, all of which are filed with the SEC and are incorporated by reference into this proxy statement/prospectus. See the sections entitled “Where You Can Find More Information” and “Incorporation of Certain Information by Reference” in this proxy statement/prospectus.

Additional Risks Related to Apexigen

Risks Related to Apexigen’s Business, Financial Condition, and Need for Additional Capital

If Apexigen does not successfully consummate the Merger or any other strategic transaction, the Apexigen Board may decide to pursue a dissolution and liquidation of Apexigen. In such an event, the amount of cash available for distribution to Apexigen’s stockholders will depend heavily on the timing of such liquidation as well as the amount of cash that Apexigen will need to reserve for commitments and contingent liabilities.

There can be no assurance that the Merger or the process to identify any other strategic alternative will result in a successfully consummated transaction. If Apexigen does not complete the Merger or any other strategic transaction, the Apexigen Board may decide to pursue a dissolution and liquidation of Apexigen. In such an event, the amount of cash available for distribution to Apexigen’s stockholders will depend heavily on the timing of such decision and, ultimately, such liquidation, since the amount of cash available for distribution will continue to decrease as Apexigen funds its operations prior to the consummation of the Merger or if it must evaluate any other strategic alternatives. In addition, if the Apexigen Board were to approve and recommend, and Apexigen’s stockholders were to approve, a dissolution and liquidation of Apexigen, it would be required under Delaware corporate law to pay its outstanding obligations, as well as to make reasonable provisions for contingent and unknown obligations, prior to making any distributions in liquidation to Apexigen’s stockholders. Apexigen’s commitments and contingent liabilities may include (i) regulatory and clinical obligations; (ii) obligations under its employment, retention and related agreements with certain employees that provide for severance and other payments following a termination of employment occurring for various reasons, including a change in control; and (iii) potential litigation against Apexigen, and other various claims and legal actions arising in the ordinary course of business. As a result of this requirement, Apexigen may need to reserve a portion of its assets pending the resolution of such obligations. In addition, Apexigen may be subject to litigation or other claims related to a dissolution and liquidation of Apexigen. If Apexigen pursues a dissolution and liquidation, the Apexigen Board, in consultation with its advisors, would need to evaluate these matters and make a determination about a reasonable amount to reserve. Accordingly, holders of Apexigen’s common stock could lose all or a significant portion of their investment in the event of a liquidation, dissolution or winding up of the Apexigen.

Apexigen has incurred net losses since inception and expects to continue to incur significant net losses for the foreseeable future. In addition, Apexigen may be unable to continue as a going concern.

Apexigen has incurred net losses since inception, has not generated any significant revenue to date, and financed its operations prior to the transactions contemplated under the definitive business combination agreement (the “Brookline Business Combination Agreement”) between Brookline Capital Acquisition Corp. (“BCAC”), Apexigen’s legal predecessor company and a special purpose acquisition company, and Apexigen America, Inc. (“Legacy Apexigen”) that closed on July 29, 2022 (the “Brookline Business Combination”) primarily through the issuance of convertible preferred stock, proceeds from collaborative research and development and out-license agreements, and borrowings under a debt arrangement. Apexigen’s net loss was $6.1 million and $9.0 million for the three months ended March 31, 2023 and 2022, respectively.

As of March 31, 2023, Apexigen had an accumulated deficit of $182.8 million. To date, Apexigen has devoted substantially all of its resources and efforts to research and development. Apexigen’s clinical-stage pipeline currently consists of multiple product candidates, including its lead product candidate, sotiga, and Apexigen’s other internal programs are in preclinical or research development. As a result, Apexigen expects that it will be several years, if ever, before Apexigen generates revenue from product sales. Even if Apexigen succeeds in receiving marketing approval for and commercializing one or more of its product candidates, Apexigen expects that it will continue to incur substantial research and development and other expenses in order to develop and market additional potential products. In addition, for certain of Apexigen’s licensees from whom Apexigen is entitled to receive royalty payments if they successfully develop and commercialize any products covered by licenses Apexigen has with them, there is no guarantee that their product development and commercialization will lead to any such payments even if any such product candidates receive regulatory approval for commercial sale, including Beovu (brolucizumab-dbll), which is commercialized by Novartis AG (“Novartis”), for which Apexigen has received sales-based royalties that are currently fully constrained and recorded as deferred revenue on Apexigen’s consolidated balance sheet, as discussed below.

In connection with the Brookline Business Combination, Apexigen raised approximately $19.0 million of gross proceeds. Apexigen incurred approximately $9.2 million in transaction costs relating to the Brookline Business Combination, consisting of banking, legal, and other professional fees. The total net cash proceeds to Apexigen were approximately $8.9 million after Apexigen paid off the Extension and Working Capital Notes that totaled $0.9 million. In addition, Apexigen raised approximately $2.8 million of gross proceeds from the private placement transaction in January 2023. Apexigen incurred approximately $0.7 million in transaction costs relating to the private placement, consisting of placement agent, legal, and other professional fees.

Apexigen’s condensed consolidated financial statements for the three months ended March 31, 2023 and 2022 have been prepared assuming Apexigen will continue as a going concern. As a development stage company, Apexigen expects to incur significant and increasing losses until regulatory approval is granted for sotiga, Apexigen’s lead product candidate. Regulatory approval is not guaranteed and may never be obtained. Based on Apexigen’s research and development activities and plans, there is uncertainty regarding Apexigen’s ability to maintain liquidity sufficient to operate the business effectively, which raises substantial doubt about Apexigen’s ability to continue as a going concern. If Apexigen does not receive proceeds under its equity line or other potential financing or business development transactions, Apexigen anticipates that its current cash position would only be sufficient to fund Apexigen’s operations into the fourth quarter of 2023 based on current operations.

Apexigen expects to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses Apexigen incurs may fluctuate significantly from quarter-to-quarter such that a period-to-period comparison of Apexigen’s results of operations may not be a good indication of its future performance. The size of Apexigen’s future net losses will depend, in part, on the rate of future growth of its expenses and its ability to generate revenue. Apexigen’s expected future losses will continue to have an adverse effect on Apexigen’s working capital and Apexigen’s ability to achieve and maintain profitability.

Apexigen will require substantial additional capital to finance its operations. If Apexigen is unable to raise such capital when needed, or on acceptable terms, Apexigen may be forced to delay, reduce, and/or eliminate one or more of Apexigen’s research and drug development programs or future commercialization efforts.

Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive, and uncertain process that takes years to complete. Apexigen expects its expenses to increase in connection with Apexigen’s ongoing activities, particularly as Apexigen conducts clinical trials of, and seeks marketing approval for sotiga and Apexigen’s other product candidates. In addition, if Apexigen obtains marketing approval for any of Apexigen’s product candidates, Apexigen expects to incur significant commercialization expenses related to drug sales, marketing, manufacturing, and distribution. Apexigen also expect to incur additional costs associated with operating as a public company. Accordingly, Apexigen will need to obtain substantial additional funding in order to maintain Apexigen’s continuing operations. If Apexigen is unable to raise capital when needed or on acceptable terms, or to enter into a collaboration to support the advancement of the sotiga development program, Apexigen may be forced to delay, reduce, and/or eliminate one or more of Apexigen’s research and drug development programs or future commercialization efforts. Changing circumstances, some of which may be beyond Apexigen’s control, could cause Apexigen to consume capital significantly faster than Apexigen currently anticipates, and Apexigen may need to seek additional funds sooner than planned.

Apexigen plans to continue to use Apexigen’s cash on hand to fund Apexigen’s development of sotiga, and for working capital and other general corporate purposes. This may include additional research, hiring additional personnel, capital expenditures, and the costs of operating as a public company. Advancing the development of Apexigen’s current and any future product candidates will require a significant amount of capital. Apexigen’s current cash and cash equivalents are not sufficient to fund all of the actions that are necessary to complete the development of sotiga or any of Apexigen’s other product candidates. Apexigen will be required to obtain further funding through public or private equity offerings, sale of shares of Apexigen’s common stock through utilization of Apexigen’s equity line with Lincoln Park, debt financings, partnership, collaborations, and licensing arrangements or other sources, which may dilute Apexigen’s stockholders or restrict Apexigen’s operating activities. In addition, there are certain conditions and limitations on Apexigen’s ability to utilize its $50.0 million equity line with Lincoln Park. Apexigen is required to satisfy various conditions in order to be able to initiate additional purchases by Lincoln Park under the equity line. Once such conditions are satisfied, the Lincoln Park equity line purchases are subject to volume limitations tied to periodic market prices, ownership limitations limiting Lincoln Park from owning more than 4.99% of Apexigen’s common stock, a minimum closing price of $3.00 per share of common stock at which Apexigen can deliver a regular purchase notice to Lincoln Park to purchase shares of common stock, and other limitations as specified in the equity line agreement. If any of these conditions are not satisfied or limitations are in effect, Apexigen may not be able to fully utilize the Lincoln Park equity line, which would have an adverse impact on Apexigen’s ability to satisfy Apexigen’s capital needs and could materially adversely impact Apexigen’s business. Adequate additional financing may not be available to Apexigen on acceptable terms, or at all. Apexigen’s failure to raise capital as and when needed would have a negative impact on its financial condition and its ability to pursue its business strategy.

Apexigen is in the early stages of clinical drug development and has a limited operating history and no products approved for commercial sale, which may make it difficult for you to evaluate Apexigen’s current business and predict its future success and viability.

Apexigen is an early clinical-stage biopharmaceutical company with a limited operating history. Apexigen was incorporated and commenced operations in 2010 following a spin-out transaction from its parent company. Apexigen has no products approved for commercial sale and has not generated any revenue from commercial product sales. Apexigen’s operations to date have been limited to performing research and development activities in support of Apexigen’s product development and licensing efforts, hiring personnel, raising capital to support and expand such activities, providing general and administrative support for these operations, developing potential product candidates, conducting preclinical studies and clinical trials, including clinical trials of sotiga, Apexigen’s lead product candidate, and Apexigen’s other wholly owned product candidates, and entering into, and performing Apexigen’s obligations under, licensing arrangements that have resulted in additional product candidates in clinical development or commercialization by Apexigen’s licensees. Other than sotiga, all of Apexigen’s wholly owned programs are in preclinical or research development. Apexigen has not yet demonstrated Apexigen’s ability to successfully complete any large-scale pivotal clinical trials, obtain marketing approvals, manufacture a drug on a commercial scale or arrange for a third party to do so on Apexigen’s behalf, or conduct sales and marketing activities. In addition, only one of Apexigen’s licensees has obtained marketing approvals for product candidates Apexigen has out-licensed. As a result, it may be more difficult for you to accurately predict Apexigen’s future success or viability than it could be if it had a longer operating history.

In addition, as a business with a limited operating history, Apexigen may encounter unforeseen expenses, difficulties, complications, delays, and other known and unknown factors and risks frequently experienced by early-stage biopharmaceutical companies in rapidly evolving fields. Apexigen also would need to transition from a company with a research and development focus to a company capable of supporting commercial activities after approval of any of Apexigen’s product candidates. Apexigen has not yet demonstrated an ability to successfully overcome such risks and difficulties, or to make such a transition. If Apexigen does not adequately address these risks and difficulties or successfully make such a transition, Apexigen’s business will suffer.

Apexigen’s ability to generate revenue and achieve profitability depends significantly on Apexigen’s ability to achieve a number of objectives.

Apexigen’s business depends entirely on the successful development and commercialization of Apexigen’s product candidates. Apexigen currently generates no revenue from commercial sales of any products. Apexigen has no products approved for commercial sale and Apexigen does not anticipate generating any revenue from product sales unless and until sometime after Apexigen has successfully completed clinical development and received marketing approval for the commercial sale of a product candidate, if ever. In addition, Apexigen may not receive significant amounts of royalty revenue, if any, from Apexigen’s licensees for their product candidates if and when such candidates receive regulatory approval for commercial sale and are commercialized, including Beovu, which is commercialized by Novartis, for which Apexigen has received sales-based royalties that are currently fully constrained and recorded as deferred revenue on Apexigen’s consolidated balance sheet as discussed below. Apexigen’s ability to generate revenue and achieve profitability depends significantly on Apexigen’s ability to achieve a number of objectives, including:

Apexigen may never achieve its objectives and, even if Apexigen does, may never generate revenue that is significant or large enough to achieve profitability. If Apexigen does achieve profitability, Apexigen may not sustain or increase profitability on a quarterly or annual basis. Apexigen’s failure to become and remain profitable would decrease the value of its company and could impair its ability to maintain or further its research and development efforts, raise additional necessary capital, grow its business, or continue its operations.

Risks Related to the Discovery, Development, and Commercialization of Apexigen’s Product Candidates

Apexigen depends on the success of its product candidates, including its lead product candidate, sotiga, which is currently in multiple clinical trials. If Apexigen is unable to obtain approval for and commercialize its product candidates for one or more indications in a timely manner, Apexigen’s business will be materially harmed.

Apexigen’s success depends on its or its partners’ or licensees’ ability to timely complete clinical trials and obtain marketing approval for, and then successfully commercialize, its product candidates, including its lead product candidate, sotiga, for one or more indications. Apexigen’s product candidates are in the early stages of development and Apexigen is investing the majority of its efforts and financial resources in the research and development of sotiga for multiple indications, both directly through Apexigen’s own efforts and indirectly through clinical collaboration arrangements, including investigator- and cooperative group-sponsored trials (“ISTs”). Apexigen’s product candidates will require additional clinical development, preclinical and manufacturing activities, marketing approval from government regulators, substantial investment, and significant marketing efforts before Apexigen generates any revenue from product sales. Apexigen is not permitted to market or promote any product candidates, in a jurisdiction before receiving marketing approval from the relevant regulatory authority, including, for example, the FDA for marketing in the United States and the EMA for marketing in the European Union, and Apexigen may never receive such marketing approvals.

The success of Apexigen’s product candidates will depend on numerous factors, including the following:

Apexigen does not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, including trial design, implementation, and timely provision of data in Apexigen’s collaboration based clinical trials and ISTs; potential threats to Apexigen’s intellectual property rights; and the manufacturing, marketing, distribution, and sales efforts of any future collaborator. If Apexigen is unable to achieve one or more of the objectives set forth above, Apexigen’s business will be materially harmed.

Apexigen’s clinical trials may reveal serious adverse events, toxicities, or other side effects of Apexigen’s current and any future product candidates that result in a safety profile that could inhibit regulatory approval or market acceptance of Apexigen’s product candidates.

In order to obtain marketing approval for Apexigen’s current or any future product candidates, Apexigen must demonstrate the safety and efficacy of the product candidate for the relevant clinical indication or indications through preclinical studies and clinical trials as well as additional supporting data. If Apexigen’s product candidates are associated with undesirable side effects in preclinical studies or clinical trials, or have unexpected characteristics, Apexigen may need to interrupt, delay, or abandon their development or limit development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe, or more acceptable from a risk-benefit perspective.

Although Apexigen has conducted various preclinical studies and has data from various early-stage clinical trials, Apexigen does not know the predictive value of these studies and trials for Apexigen’s future clinical trials, and Apexigen cannot guarantee that any positive results in preclinical studies or previous clinical trials will successfully translate to patients in Apexigen’s future clinical trials. It is not uncommon to observe results in clinical trials that are unexpected based on preclinical testing or previous clinical trials, and many product candidates fail in clinical trials despite promising preclinical or early-stage clinical results. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval for their products.

While Apexigen believes that sotiga has been reasonably well tolerated in Apexigen’s clinical trials, subjects have experienced adverse events that have been considered treatment-related. Some of the more common adverse events included fever, chills, fatigue, asthenia, nausea, vomiting, pruritus, abnormal liver function/gamma gamma-glutamyl transferase/alkaline phosphatase tests, decreased appetite, rash, headache, diarrhea, infusion-related reactions, and cytokine release syndrome. The majority of these events were mild/moderate in severity, responded to symptomatic treatment and/or were transient and resolved with time.

Serious, including sometimes fatal, adverse events (“SAEs”) have been reported in clinical studies with sotiga. The majority of these SAEs were considered unrelated to sotiga by the investigators. Some SAEs were considered at least possibly related to sotiga as well as possibly to other therapies it was combined with.

These possibly related events have included infusion-related reactions, complete responses (“CRs”), elevated liver enzymes, bilirubin, fever, and colitis. Less frequent related SAEs reported in one patient each have included kidney injury, hepatic failure, bleeding, immune-mediated encephalitis, myositis, optic neuritis. Many of these SAEs were also considered possibly related to the chemotherapy, radiation or anti- PD-1 or PD L1 (together “PD-(L)1”) agent that were used in combination or were assessed as not related to sotiga after a safety review by the trial sponsor.

Subjects experienced numerous other SAEs that have been determined to be caused by their health condition or the side effects from other components of the treatment regimens, and not or unlikely related to sotiga. Given the high mortality rates of the cancers for which Apexigen is initially pursuing development, in particular melanoma, esophageal and gastroesophageal junction (“GEJ”) cancers, sarcoma, and ovarian cancer, and the pretreated nature of many patients in Apexigen’s completed, ongoing and planned clinical trials of sotiga, a number of these subjects have died as a result of their cancer or from direct side effects of surgery and other treatment regimens for their cancer. For example, in Apexigen’s clinical trial for esophageal and GEJ cancers, sotiga is combined with standard of care neoadjuvant chemotherapy, radiation and surgery. These standard of care treatments alone are associated with significant toxicities including fatal outcomes, and in this study, complications of surgery have resulted in the death of a patient.

Apexigen expects that subjects in Apexigen’s ongoing and planned clinical trials for Apexigen’s product candidates may in the future suffer adverse events (“AEs”), SAEs or other side effects, including those not observed in Apexigen’s preclinical studies or previous clinical trials. Results of these trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Undesirable side effects caused by Apexigen’s product candidates could result in the delay, suspension, or termination of clinical trials by Apexigen or the FDA, EMA or comparable foreign regulatory authority for a number of reasons. Additionally, a number of the subjects in these clinical trials are expected to die during a trial due to the cancers they suffer and any of the treatment regimens they may have previously experienced, which could impact the development of Apexigen’s product candidates. If Apexigen elects or is required to delay, suspend, or terminate any clinical trial, the commercial prospects of Apexigen’s product candidates will be harmed and Apexigen’s ability to generate product revenue from this product candidate will be delayed or eliminated. SAEs observed in clinical trials could hinder or prevent market acceptance of Apexigen’s drug candidates. Any of these occurrences may harm Apexigen’s business, prospects, financial condition, and results of operations significantly.

Even in circumstances in which Apexigen does not believe that an AE is related to Apexigen’s product candidates, the investigation into the circumstances of such AE may be time-consuming or inconclusive. In particular, patients may face serious medical issues associated with the underlying cancer indications that Apexigen’s product candidates target, as well as AEs from toxicities and other complications related to other study drugs administered alongside or in combination with Apexigen’s product candidates in clinical trials. For example, some of Apexigen’s clinical trials involve combination therapies of Apexigen’s product candidate with other cancer therapies, such as standard-of-care chemotherapy, chemoradiation or anti-PD-(L)1 agents. In these trials, it is difficult to ascertain whether treatment-related AEs are attributable to Apexigen’s product candidates or to the other agents, and the combination of therapies may have a complicating multiplier effect on such AEs that cannot be determined. As a result, while not directly associated with Apexigen’s product candidates, there are attendant risks with the space in which Apexigen’s product candidates operate, and any related investigations may interrupt Apexigen’s development and commercialization efforts, delay Apexigen’s regulatory approval process or impact and limit the type of regulatory approvals Apexigen’s product candidates receive or maintain.

If further SAEs or other side effects are observed in any of Apexigen’s current or future clinical trials, Apexigen may have difficulty recruiting patients to the clinical trials, patients may discontinue treatment or withdraw from Apexigen’s trials or Apexigen may be required to abandon the trials or Apexigen’s development efforts of that product candidate altogether. We, the FDA, the EMA, other applicable regulatory authorities or an Institutional Review Board (“IRB”)/Ethics Committee may suspend clinical trials of a product candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptable health risks or adverse side effects. Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic promise in early-stage studies have later been found to cause side effects that prevented their further development. Even if the side effects do not preclude a drug from obtaining or maintaining marketing approval, undesirable side effects may inhibit market acceptance of the approved product due to its tolerability versus other therapies. Any of these developments could materially harm Apexigen’s business, financial condition, and prospects.

Further, if any of Apexigen’s product candidates obtains marketing approval, toxicities associated with Apexigen’s product candidates may also develop after such approval and lead to a requirement to conduct additional clinical safety trials, additional warnings being added to the labeling, significant restrictions on the use of the product, or the withdrawal of the product from the market. Apexigen cannot predict whether its product candidates will cause toxicities in humans that would preclude or lead to the revocation of regulatory approval based on preclinical studies or early-stage clinical testing.

If Apexigen experiences delays or difficulties in the enrollment of patients in clinical trials, its receipt of necessary marketing approvals could be delayed or prevented.

Apexigen may not initiate, continue or complete clinical trials for its product candidates if Apexigen is unable to locate and enroll a sufficient number of eligible patients to participate in these trials as required by the FDA, EMA, or comparable foreign regulatory authorities.

Patient enrollment is a significant factor in the timing of clinical trials, and Apexigen’s ability to enroll eligible patients may be limited or may result in slower enrollment than Apexigen anticipates. Patient enrollment may also be affected by other factors, including:

Apexigen’s inability to enroll a sufficient number of patients for Apexigen’s clinical trials would result in significant delays or may require Apexigen to abandon one or more of its clinical trials altogether. Enrollment delays in Apexigen’s clinical trials may result in increased development costs for its product candidates and jeopardize its ability to obtain marketing approval for the sale of its product candidates.

The clinical trials of Apexigen’s current and any future product candidates may not demonstrate safety and efficacy to the satisfaction of regulatory authorities or otherwise be timely conducted or produce positive results.

Before obtaining marketing approval from regulatory authorities for the sale of Apexigen’s product candidates, Apexigen must complete preclinical development and then conduct extensive clinical trials to demonstrate the safety and efficacy of Apexigen’s product candidates. Clinical testing is expensive, difficult to design and implement, can take many years to complete, and its ultimate outcome is uncertain. A failure of one or more clinical trials can occur at any stage of the process. The outcome of preclinical studies and early-stage clinical trials may not be predictive of the success of later clinical trials. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their drugs. In addition, in Apexigen’s clinical trials of sotiga that are in combination with other available therapies, the results may be uncertain as to the efficacy of the sotiga combination when compared to the efficacy of other therapies that are being applied in the trial.

Apexigen does not know whether its future clinical trials will begin on time or enroll patients on time, or whether Apexigen’s ongoing and/or future clinical trials will be completed on schedule or at all. Clinical trials can be delayed for a variety of reasons, including delays related to:

Any unforeseen events may cause Apexigen to be required to conduct additional clinical trials or other testing of Apexigen’s product candidates beyond those that Apexigen currently contemplates, or to be unable to successfully complete clinical trials of Apexigen’s product candidates or other testing. Clinical trial or test results may also not be positive or may be only modestly positive or may have safety concerns. For example, in the APX005M-002 Trial, Apexigen enrolled 95 patients with non-small cell lung cancer (“NSCLC”) who were either immunotherapy naïve or who had progressed while on anti-PD(L)1 therapy and treated those patients with sotiga in combination with nivolumab. Although Apexigen observed a modest number of objective responses in immunotherapy naïve patients and stable disease in patients who had previously progressed on or were refractory to prior anti-PD-(L)1 therapy, the data did not support advancing the development of sotiga in these lines of therapy in patients with NSCLC. Any of the foregoing events may cause Apexigen to incur unplanned costs, be delayed in obtaining marketing approval, if ever, receive more limited or restrictive marketing approval, be subject to additional post-marketing testing requirements, or have the drug removed from the market after obtaining marketing approval.

The outcome of preclinical testing and early clinical trials that Apexigen obtains and that it publishes may not predict the success of later clinical trials, and the results of Apexigen’s clinical trials may not satisfy the requirements of the FDA, EMA, or comparable foreign regulatory authorities.

Apexigen currently has no products approved for sale and it cannot guarantee that it will ever have marketable drugs. Clinical failure can occur at any stage of clinical development. Clinical trials may produce negative or inconclusive results, and Apexigen or any future collaborators may decide, or regulators may require us, to conduct additional clinical trials or preclinical studies. Apexigen will be required to demonstrate with substantial evidence through well-controlled clinical trials that Apexigen’s product candidates are safe and effective for use in a diverse population before Apexigen can seek marketing approvals for their commercial sale. Success in preclinical studies and early-stage clinical trials does not mean that future larger registration clinical trials will be successful. This is because product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the satisfaction of the FDA, EMA, and other regulatory authorities despite having progressed through preclinical studies and early-stage clinical trials. In particular, no compound with the mechanism of action of sotiga has been commercialized, and the outcome of preclinical studies and early-stage clinical trials may not be predictive of the success of later-stage clinical trials. Apexigen does not know whether any clinical trials it may conduct will demonstrate consistent or adequate efficacy and safety results sufficient to obtain marketing approval to market Apexigen’s product candidates.

Summary or preliminary data from Apexigen’s clinical trials that it announces or publishes may change as new or revised patient data becomes available, and is subject to source verification procedures that could result in material changes in the final data.

As more patient data becomes available, Apexigen may publicly disclose new or revised preliminary data from its clinical trials. These preliminary updates are based on analyses of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. Apexigen also makes assumptions, estimations, calculations and conclusions as part of its analyses of data, and it may not have received or had the opportunity to evaluate all data fully and carefully. As a result, the summary or preliminary results that Apexigen reports may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Summary or preliminary data also remain subject to source verification procedures that may result in the final data being materially different from the summary or preliminary data Apexigen previously published. As a result, summary or preliminary data should be viewed with caution until the final data are available. In addition, Apexigen may report interim analyses of only certain endpoints rather than all endpoints. Preliminary data from clinical trials that Apexigen conducts may not be indicative of the final results of the trials and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Adverse changes between preliminary data and final data could significantly harm Apexigen’s business and prospects. Further, additional disclosure of preliminary data by Apexigen or by Apexigen’s competitors in the future could result in volatility in the price of Apexigen’s common stock.

Further, others, including regulatory agencies, may not accept or agree with Apexigen’s assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate, and Apexigen’s company in general. In addition, the information Apexigen chooses to publicly disclose regarding a particular study or clinical trial is typically selected from a more extensive amount of available information. Interested parties may not agree with what Apexigen determines is the material or otherwise appropriate information to include in Apexigen’s disclosure, and any information Apexigen determines not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities, or otherwise regarding a particular product candidate or Apexigen’s business. If the preliminary or topline data that Apexigen reports differ from late, final or actual results, or if others, including regulatory authorities, disagree with the conclusions reached, Apexigen’s ability to obtain approval for, and commercialize, Apexigen’s product candidates may be harmed, which could harm Apexigen’s business, financial condition, results of operations, and prospects.

In some instances, there can be significant variability in safety and efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial protocols, differences in size and type of the patient populations, differences in and adherence to the dosing regimen and other trial protocols, use in combination with other therapies, and the rate of discontinuations by clinical trial participants. In addition, Apexigen may use patient-reported outcome assessments in some of Apexigen’s clinical trials, which involve patients’ subjective assessments of efficacy of the treatments they receive in the trial. Such assessments can vary widely from day to day for a particular patient, and from patient to patient and site to site within a clinical trial. This subjectivity can increase the uncertainty of, and adversely impact, Apexigen’s clinical trial outcomes.

Apexigen’s product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors, and others in the medical community necessary for commercial success.

Even if Apexigen’s product candidates receive regulatory approval, they may not gain adequate market acceptance among physicians, patients, healthcare payors, and others in the medical community. For example, current standard-of-care cancer treatments, such as existing chemotherapy and radiation therapy, are well established in the medical community, and doctors may continue to rely on these treatments. The degree of market acceptance of any of Apexigen’s approved product candidates, if approved for commercial sale, will depend on a number of factors, including:

If any product candidate is approved but does not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors, and patients, Apexigen may generate less revenue from that product candidate than anticipated, which could harm Apexigen’s financial results.

The sizes of the patient populations suffering from some of the diseases Apexigen is targeting may be based on estimates that are inaccurate, may be small, or may be smaller than estimated.

Apexigen relies on estimates to project the incidence and prevalence of diseases Apexigen is targeting and the subset of patients with these diseases who have the potential to benefit from treatment with sotiga and Apexigen’s other product candidates. Apexigen derives these estimates from a variety of sources, including United States and global cancer databases, scientific literature, surveys of clinics, physician interviews, patient foundations, and market research, and they may prove to be incorrect. Further, new studies may change the estimated incidence or prevalence of these diseases. The number of patients may turn out to be lower than expected. Additionally, the potentially addressable patient population for sotiga and any other future product candidates may be more limited than Apexigen originally estimated or may not be amenable to treatment with sotiga and any other product candidates, if and when approved. For example, in March 2022, the FDA approved nivolumab and relatlimab-rmbw (Opdualag^TM) for use in patients with unresectable or metastatic melanoma, which may limit the number of patients with unresectable or metastatic melanoma that have progressive disease during treatment with anti-PD-(L)1 therapy, which would be the target population for a potential registration-enabling study of sotiga in combination with a PD-(L)1 inhibitor that Apexigen is considering. Even if Apexigen obtains significant market share for sotiga and any other product candidates, small potential target populations for certain indications means Apexigen may never achieve profitability without obtaining market approval for additional indications.

Many of Apexigen’s additional internal programs, including APX601, are at earlier stages of development than sotiga and may fail in development or suffer delays, including if Apexigen is unable to raise adequate additional funding, that adversely affect their commercial viability.

Other than sotiga, all of Apexigen’s internal programs are in preclinical development or at the research stage and may fail in development or suffer delays that adversely affect their commercial viability. These programs may fail to yield product candidates. A product candidate can unexpectedly fail at any stage of preclinical and clinical development. The historical failure rate for product candidates is high due to risks relating to safety, efficacy, clinical execution, changing standards of medical care, and other unpredictable variables. The results from preclinical testing or early clinical trials of a product candidate may not be predictive of the results that will be obtained in later-stage clinical trials of the product candidate. The success of any product candidates Apexigen may develop will depend on many factors, including the following:

Apexigen will need additional funding to continue to advance the development of Apexigen’s other internal programs, including APX601. If Apexigen is unable to secure adequate funding to continue such development, Apexigen expects that Apexigen will be required to delay or stop the development of such programs.

Even if Apexigen successfully advances any other product candidates into clinical development, their success will be subject to all of the clinical, regulatory and commercial risks described elsewhere in this “Risk Factors” section. Accordingly, Apexigen cannot assure you that Apexigen will ever develop, obtain regulatory approval of, commercialize, or generate significant revenue from any product candidate.

Any product candidates Apexigen develops may become subject to unfavorable third-party reimbursement practices and pricing regulations.

The availability and extent of coverage and adequate reimbursement by governmental and private payors is essential for most patients to afford the expense of antibody therapeutics like sotiga and Apexigen’s other product candidates. Sales of any of Apexigen’s product candidates that receive marketing approval will depend substantially, both in the United States and internationally, on the extent to which the costs of Apexigen’s product candidates will be paid by health maintenance, managed care, pharmacy benefit, and similar healthcare management organizations or reimbursed by government health administration authorities, private health coverage insurers, and other third-party payors. If reimbursement is not available, or is available only to limited levels, Apexigen may not successfully commercialize Apexigen’s product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow Apexigen to establish or maintain pricing sufficient to realize an adequate return on Apexigen’s investment. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which Apexigen obtains marketing approval. If coverage and reimbursement are not available or reimbursement is available only to limited levels, Apexigen may not successfully commercialize any product candidate for which Apexigen obtains marketing approval.

There is significant uncertainty related to insurance coverage and reimbursement of newly approved products. In the United States, principal decisions about reimbursement for new products are typically made by Centers for Medicare & Medicaid Services (“CMS”), an agency within the U.S. Department of Health and Human Services (“HHS”). CMS decides whether and to what extent a new product will be covered and reimbursed under Medicare, and private payors often follow CMS’s decisions regarding coverage and reimbursement to a substantial degree. However, one payor’s determination to provide coverage for a drug product does not assure that other payors will also provide coverage for the drug product. As a result, the coverage determination process is often time-consuming and costly. This process will require Apexigen to provide scientific and clinical support for the use of Apexigen’s products to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

Increasingly, third-party payors require that drug companies provide them with predetermined discounts from list prices and challenge the prices charged for medical products. Further, such payors increasingly challenge the price, examine the medical necessity and review the cost effectiveness of medical drug products. There may be especially significant delays in obtaining coverage and reimbursement for newly approved drugs. In August 2022, Congress passed the Inflation Reduction Act of 2022, which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes.

Third-party payors may limit coverage to specific drug products on an approved list, known as a formulary, which might not include all FDA-approved drugs for a particular indication. Apexigen may need to conduct expensive studies to demonstrate the medical necessity and cost-effectiveness of Apexigen’s products. Nonetheless, Apexigen’s product candidates may not be considered medically necessary or cost effective. Apexigen cannot be sure that coverage and reimbursement will be available for any product that Apexigen commercializes and, if reimbursement is available, what the level of reimbursement will be.

Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and Apexigen believes the increasing emphasis on cost-containment initiatives in Europe, Canada and other countries has and will continue to put pressure on the pricing and usage of therapeutics such as Apexigen’s product candidates. In many countries, particularly the countries of the European Union, medical product prices are subject to varying price control mechanisms as part of national health systems. In these countries, pricing negotiations with governmental authorities can take considerable time after a product receives marketing approval. To obtain reimbursement or pricing approval in some countries, Apexigen may be required to conduct a clinical trial that compares the cost-effectiveness of Apexigen’s product candidate to other available therapies. In general, product prices under such systems are substantially lower than in the United States. Other countries allow companies to fix their own prices for products, but monitor and control company profits.

Additional foreign price controls or other changes in pricing regulation could restrict the amount that Apexigen is able to charge for Apexigen’s product candidates. Accordingly, in markets outside the United States, the reimbursement for Apexigen’s products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenue and profits.

If Apexigen is unable to establish or sustain coverage and adequate reimbursement for any future product candidates from third-party payors, the adoption of those products and sales revenue will be adversely affected, which, in turn, could adversely affect the ability to market or sell those product candidates. Coverage policies and third-party reimbursement rates may change at any time. Even if Apexigen attains favorable coverage and reimbursement status for one or more products for which Apexigen receives regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

If Apexigen’s competitors develop and market products that are more effective, safer, or less expensive than its product candidates, Apexigen’s commercial opportunities will be negatively impacted.

The biotechnology industry is highly competitive and subject to rapid and significant technological change. Moreover, the oncology field is characterized by strong and increasing competition, with a strong emphasis on intellectual property. Products Apexigen may develop in the future for the treatment of cancer and any other diseases are likely to face competition from other drugs and therapies, including those of which Apexigen may not currently be aware. In addition, Apexigen’s products may need to compete with off-label drugs used by physicians to treat the indications for which Apexigen seeks approval. This may make it difficult for Apexigen to replace existing therapies with Apexigen’s products.

Major multinational pharmaceutical and biotechnology companies, emerging and start-up companies, universities, and other research institutions, could focus their future efforts on developing competing therapies and treatments for any of the indications Apexigen is currently targeting or may target in the future. For example, each of Hoffman-La Roche AG, Janssen Biotech, Inc., a subsidiary of Johnson & Johnson (in collaboration with Alligator Bioscience AB), Celldex Therapeutics, Inc., Seagan Inc., Eucure Biopharma, a subsidiary of Biocytogen, Lygen Pharma and AbbVie Inc. are developing CD40-based antibody product candidates for solid tumor oncology indications, typically in combination therapies, and other companies and institutions have other CD40-based product candidates in development.

Many of these current and potential competitors have significantly greater financial, manufacturing, marketing, drug development, technical and human resources, and commercial expertise than Apexigen does. Large pharmaceutical and biotechnology companies, in particular, have extensive experience in clinical testing, obtaining regulatory approvals, recruiting patients, and manufacturing biotechnology products. These companies also have significantly greater research, development, and marketing capabilities than Apexigen does and may also have products that have been approved or are in late stages of development, and collaborative arrangements in Apexigen’s target markets with leading companies and research institutions. Established pharmaceutical and biotechnology companies may also invest heavily to accelerate discovery and development of novel compounds or to in-license novel compounds that could make the product candidates that Apexigen develops obsolete. As a result of any of these factors, Apexigen’s competitors may succeed in obtaining approval from the FDA, EMA, or foreign regulatory authorities or discovering, developing, and commercializing products in Apexigen’s field before or more successfully than Apexigen does.

Smaller and other early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These companies compete with Apexigen in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for planned clinical trials, as well as in acquiring technologies complementary to, or necessary for, Apexigen’s programs. In addition, the biotechnology industry is characterized by rapid technological change. If Apexigen fails to stay at the forefront of technological change, Apexigen may be unable to compete effectively. Technological advances or products developed by Apexigen’s competitors may render Apexigen’s technologies or product candidates obsolete, less competitive or not economical.

Apexigen has limited resources and is currently focusing Apexigen’s efforts on developing sotiga. As a result, Apexigen may fail to capitalize on other product candidates or indications that may ultimately have proven to be more profitable.

Apexigen is currently focusing its efforts on completing clinical trials of sotiga for a variety of indications, including sarcoma, esophageal and GEJ cancers and melanoma. As a result, Apexigen may forego or delay pursuit of opportunities for other indications or with other product candidates that may have greater commercial potential. Apexigen’s resource allocation decisions may cause Apexigen to fail to capitalize on viable product candidates or profitable market opportunities. Apexigen’s spending on current and future research and development activities for specific indications may not yield any commercially viable drugs. If Apexigen does not accurately evaluate the commercial potential or target markets for a particular product candidate, Apexigen may relinquish valuable rights to that product candidate through collaboration, licensing, or other strategic arrangements in cases in which it would have been more advantageous for Apexigen to retain sole development and commercialization rights to such product candidate.

Apexigen is developing some of its product candidates for use in combination with standard-of-care as well as emerging or experimental cancer therapies, which exposes Apexigen to several risks beyond Apexigen’s control.

Apexigen is developing some of its product candidates, including sotiga, for use in combination with current standard of care or other emerging or experimental cancer therapies. This exposes Apexigen to supply risk to the extent there is not an adequate supply of these therapies for use in combination with Apexigen’s product candidates, either in clinical trials or after any approval, as well as pricing risk if these combination therapies are expensive and the addition of Apexigen’s product candidates would be too costly to support reimbursement or payor coverage. In particular, providers of some of these emerging or experimental therapies have been contributing their therapies to use in combination trials at generally no or limited cost to us. If this were to change, Apexigen’s trial costs could increase substantially. Also, although combinations with an experimental agent that has not been approved may prove to be clinically beneficial, the experimental agent will still need to meet regulatory approval requirements for the combined therapy to become commercially available. In addition, if the standard of care were to evolve or change, the clinical utility of Apexigen’s product candidates could be diminished or eliminated. If any of these were to occur, Apexigen’s business could be materially harmed.

Apexigen may use companion diagnostics in the future in Apexigen’s development programs, and if such companion diagnostics for Apexigen’s product candidates are not successfully, and in a timely manner, validated, developed, or approved, Apexigen may not achieve marketing approval or realize the full commercial potential of its product candidates.

Apexigen may use companion diagnostics in Apexigen’s future product candidate development programs. If such companion diagnostics are developed in conjunction with clinical programs, the FDA, EMA, or comparable regulatory authority may require regulatory approval of a companion diagnostic as a condition to approval of the product candidate. For example, if Apexigen uses a diagnostic to test which patients are most likely to benefit from Apexigen’s product candidate for the treatment of a particular indication as a criterion for enrollment, then Apexigen will likely be required to obtain FDA approval or clearance of the companion diagnostic, concurrent with approval of Apexigen’s product candidate. Apexigen may also be required to demonstrate to the FDA the predictive utility of a companion diagnostic, i.e., that the diagnostic selects for patients in whom the therapy will be effective or more effective compared to patients not selected for by the diagnostic. Apexigen does not have experience or capabilities in developing or commercializing diagnostics and plans to rely in large part on third parties to perform these functions. Apexigen does not currently have any agreement in place with any third party to develop or commercialize companion diagnostics for any of Apexigen’s product candidates. Companion diagnostics are subject to regulation by the FDA, the EMA, and other foreign regulatory authorities as medical devices and require separate regulatory approval or clearance prior to commercialization.

If Apexigen or its partners, or any third party, are unable to successfully develop companion diagnostics in the future in Apexigen’s product candidates, or experience delays in doing so:

In addition, any future product candidates developed in conjunction with companion diagnostics may be perceived negatively compared to alternative treatments that do not require the use of companion diagnostics, either due to the additional cost of the companion diagnostic, the requirement of samples for testing, or the need to complete additional procedures to identify genetic markers prior to administering Apexigen’s product candidates. If any of these events were to occur, it would significantly harm Apexigen’s business, results of operations and prospects.

Apexigen’s business entails a significant risk of product liability, and if Apexigen does not obtain sufficient insurance coverage, the costs of product liability could have an adverse effect on Apexigen’s business and financial condition.

Apexigen’s business exposes Apexigen to significant product liability risks inherent in the development, testing, manufacturing, and marketing of therapeutic treatments. Product liability claims could delay or prevent completion of Apexigen’s development programs. If Apexigen succeeds in marketing products, such claims could result in an FDA, EMA, or other regulatory investigation of the safety and effectiveness of Apexigen’s products, Apexigen’s manufacturing processes and facilities, or Apexigen’s marketing programs. Such regulatory investigation could potentially lead to a recall of Apexigen’s products or more serious enforcement action, limitations on the approved indications for which they may be used, or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in decreased demand for Apexigen’s products, injury to Apexigen’s reputation, costs to defend the related litigation, a diversion of management’s time and Apexigen’s resources, and substantial monetary awards to trial participants or patients. Apexigen would expect to obtain product liability insurance prior to marketing any of Apexigen’s product candidates. Any insurance Apexigen has now or that Apexigen may obtain may not provide sufficient coverage against potential liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, Apexigen may be unable to obtain sufficient insurance at a reasonable cost to protect Apexigen against losses caused by product liability claims that could have an adverse effect on Apexigen’s business and financial condition.

Risks Related to Regulatory Approval and Other Legal Compliance Matters for Apexigen’s Product Candidates

The regulatory approval processes of the FDA, the EMA, and comparable foreign regulatory authorities are lengthy, time-consuming and inherently unpredictable. If Apexigen is ultimately unable to obtain regulatory approval for Apexigen’s product candidates, Apexigen will be unable to generate product revenue and Apexigen’s business will be substantially harmed.

The time required to obtain approval by the FDA, EMA, and comparable foreign regulatory authorities is unpredictable, typically takes many years following the commencement of clinical trials, and depends upon numerous factors, including the type, complexity, and novelty of the product candidates involved. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that Apexigen’s data are insufficient for approval and require additional preclinical, clinical, or other studies. For example, FDA’s Oncology Center of Excellence initiated Project Optimus to reform the dose optimization and dose selection paradigm in oncology drug development and Project FrontRunner to help develop and implement strategies to support approvals in early clinical setting, among other goals. How the FDA plans to implement these goals and their impact on specific clinical programs and the industry are unclear. Apexigen has not submitted for, or obtained regulatory approval for, any product candidate, and it is possible that none of Apexigen’s existing product candidates or any product candidates Apexigen may seek to develop in the future will ever obtain regulatory approval.

Applications for Apexigen’s product candidates could fail to receive regulatory approval in an initial or subsequent indication for many reasons, including the following:

Further, development of Apexigen’s product candidates and/or regulatory approval may be delayed for reasons beyond Apexigen’s control. For example, a U.S. federal government shutdown or budget sequestration, such as ones that occurred during 2018 and 2019, or other FDA priorities, such as responding to COVID-19, may result in significant reductions to, or demands on, the FDA’s budget, employees, and operations, which may lead to slower response times and longer review periods, potentially affecting Apexigen’s ability to progress development of Apexigen’s product candidates or obtain regulatory approval for Apexigen’s product candidates.

This lengthy approval process, as well as the unpredictability of the results of clinical trials, may result in Apexigen’s failing to obtain regulatory approval to market any of Apexigen’s product candidates, which would significantly harm Apexigen’s business, results of operations, and prospects.

Apexigen’s product candidates may cause undesirable side effects or have other properties that could prevent their regulatory approval or result in significant negative consequences.

Adverse events or other undesirable side effects caused by Apexigen’s product candidates could cause Apexigen or regulatory authorities to interrupt, delay, or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, EMA, or other comparable foreign regulatory authorities. Drug-related side effects could affect patient recruitment, the ability of enrolled patients to complete the trial, and/or result in potential product liability claims. Regardless of merit or eventual outcome, product liability claims may result in impairment of Apexigen’s business reputation, withdrawal of clinical trial participants, costs due to related litigation, distraction of management’s attention from Apexigen’s primary business, initiation of investigations by regulators, substantial monetary awards to patients or other claimants, the inability to commercialize Apexigen’s product candidates, and decreased demand for Apexigen’s product candidates, if approved for commercial sale.

Additionally, if one or more of Apexigen’s product candidates receives marketing approval, and Apexigen or others later identify undesirable side effects or adverse events caused by such products, a number of potentially significant negative consequences could result, including:

Any of these events could prevent Apexigen from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm Apexigen’s business, financial condition, results of operations, and growth prospects.

For any current and future clinical trials for Apexigen’s product candidates outside the United States, the FDA, EMA, and applicable foreign regulatory authorities may not accept data from such trials.

Apexigen conducts clinical trials outside the United States, including in Europe, and Apexigen may choose to conduct future clinical trials outside the United States. The acceptance of study data from clinical trials conducted outside the United States or another jurisdiction by the FDA, EMA, or applicable foreign regulatory authority may be subject to certain conditions. In cases where data from foreign clinical trials are intended to serve as the basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless the data are applicable to the United States population and United States medical practice, and the trials were performed by clinical investigators of recognized competence and pursuant to Good Clinical Practice (“GCP”) regulations. Additionally, the FDA’s clinical trial requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory bodies have comparable approval requirements, including appropriate examination of the product in the country-specific population. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA, EMA, or any applicable foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction. If the FDA, EMA, or any applicable foreign regulatory authority does not accept such data, it may result in the need for additional trials, which would be costly and time-consuming and delay aspects of Apexigen’s business plan, and may result in Apexigen’s product candidates not receiving approval or clearance for commercialization in the applicable jurisdiction.

Obtaining and maintaining regulatory approval of Apexigen’s product candidates in one jurisdiction does not mean that Apexigen will succeed in obtaining regulatory approval of Apexigen’s product candidates in other jurisdictions.

Obtaining and maintaining regulatory approval of Apexigen’s product candidates in one jurisdiction does not guarantee that Apexigen will obtain or maintain regulatory approval in any other jurisdiction, but a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA, EMA, or comparable foreign regulatory authority grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing, and promotion of the product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that Apexigen intends to charge for Apexigen’s products is also subject to approval. Obtaining foreign regulatory approvals and compliance with foreign regulatory requirements could result in significant delays, difficulties, and costs for Apexigen and could delay or prevent the introduction of Apexigen’s products in certain countries. If Apexigen or any partner Apexigen works with fails to comply with the regulatory requirements in international markets or fails to receive applicable marketing approvals, Apexigen’s target market will be reduced, and Apexigen’s ability to realize the full market potential of Apexigen’s product candidates will be harmed.

Even if Apexigen applies for and obtains accelerated approval or Breakthrough Therapy, Fast Track or other designation intended to expedite, facilitate or reduce the cost of pursuing development or regulatory review or approval with the FDA or other regulatory authorities for any of Apexigen’s product candidates, there is no guarantee that such designation would lead to faster development, regulatory review, or approval, nor would it increase the likelihood that any such product candidate will receive marketing approval.

If a product candidate is intended for the treatment of a serious condition and nonclinical or clinical data demonstrate the potential to address unmet medical need for such condition or a substantial improvement over available therapy for such condition, a product candidate sponsor may apply for FDA Fast Track or Breakthrough Therapy designation, and there may be other priority designations available under various regulatory bodies. In the future, Apexigen may apply for such priority designation depending on the results of Apexigen’s clinical trials. Even though Apexigen may apply for and receive a Fast Track, Breakthrough Therapy or other priority designations, such priority designation does not ensure that Apexigen will receive marketing approval or that approval will be granted within any particular timeframe. Apexigen may not experience a faster development or regulatory review or approval process with the priority designation compared to conventional FDA procedures. In addition, the FDA may withdraw Fast Track or Breakthrough Therapy designation if it believes that the designation is no longer supported by data from Apexigen’s clinical development program. Fast Track or Breakthrough Therapy designation alone does not guarantee qualification for the FDA’s priority review procedures. Further, even if any of Apexigen’s products obtain Fast Track or Breakthrough Therapy designation, this may not lead to earlier regulatory approval or commercialization of Apexigen’s products due to the extensive and time-consuming steps necessary to obtain FDA approval and commercialize a product candidate. In December 2022, the Consolidated Appropriations Act, 2023, including the Food and Drug Omnibus Reform Act (FDORA), was signed into law. FDORA made several changes to the FDA’s authorities and its regulatory framework, including, among other changes, reforms to the accelerated approval pathway, such as requiring the FDA to specify conditions for post-approval study requirements and setting forth procedures for the FDA to withdraw a product on an expedited basis for non-compliance with post-approval requirements.

Even if Apexigen obtains regulatory approval for a product candidate, Apexigen’s products will remain subject to extensive regulatory scrutiny.

If any of Apexigen’s product candidates are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy, and other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities.

Manufacturers and manufacturers’ facilities are required to comply with extensive requirements imposed by the FDA, EMA, and comparable foreign regulatory authorities, including ensuring that quality control and manufacturing procedures conform to Good Manufacturing Practice (“GMP”) regulations. As such, Apexigen or its contract manufacturers will be subject to continual review and inspections to assess compliance with GMP and adherence to commitments made in any BLA, NDA, or Marketing Authorization Application (“MAA”). Accordingly, Apexigen or others with whom Apexigen works must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, and quality control.

Any regulatory approvals that Apexigen receives for Apexigen’s product candidates will be subject to limitations on the approved indicated uses for which the product may be marketed and promoted or to the conditions of approval (including potentially the requirement to implement a REMS), or contain requirements for potentially costly post-marketing testing. Apexigen will be required to report certain adverse reactions and production problems, if any, to the FDA, EMA, and comparable foreign regulatory authorities. Any new legislation addressing drug safety issues could result in delays in product development or commercialization, or increased costs to assure compliance. The FDA and other agencies, including the Department of Justice (the “DOJ”), closely regulate and monitor the post-approval marketing and promotion of products to ensure that they are manufactured, marketed, and distributed only for the approved indications and in accordance with the provisions of the approved labeling. Apexigen will have to comply with requirements concerning advertising and promotion for Apexigen’s products. Promotional communications with respect to prescription drugs are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the product’s approved label. As such, Apexigen may not promote Apexigen’s products for indications or uses for which they do not have approval. The holder of an approved BLA, NDA, or MAA must submit new or supplemental applications and obtain approval for certain changes to the approved product, product labeling, or manufacturing process. Apexigen could also be asked to conduct post-marketing clinical trials to verify the safety and efficacy of Apexigen’s products in general or in specific patient subsets. If original marketing approval was obtained via the accelerated approval pathway, Apexigen could be required to conduct a successful post-marketing clinical trial to confirm clinical benefit for Apexigen’s products. An unsuccessful post-marketing study or failure to complete such a study could result in the withdrawal of marketing approval.

If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, or disagrees with the promotion, marketing, or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market. If Apexigen fails to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things:

Any government investigation of alleged violations of law could require Apexigen to expend significant time and resources in response, and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect Apexigen’s ability to commercialize and generate revenue from Apexigen’s products. If regulatory sanctions are applied or if regulatory approval is withdrawn, this would significantly harm Apexigen’s business, financial condition, results of operations, and growth prospects.

Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on Apexigen’s business and results of operations.

Third-party payors, whether domestic or foreign, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In both the United States and certain foreign jurisdictions, there have been a number of legislative and regulatory changes to the healthcare system that could impact Apexigen’s ability to sell its products profitably. In particular, in 2010, the Patient Protection and Affordable Care Act (“ACA”) was enacted, which, among other things, subjected biologic products to potential competition by lower-cost biosimilars, addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program, extended the Medicaid Drug Rebate Program to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations, subjected manufacturers to new annual fees and taxes for certain branded prescription drugs, and provided incentives to programs that increase the federal government’s comparative effectiveness research. Complying with any new legislation or reversing changes implemented under the ACA could be time-intensive and expensive, resulting in a material adverse effect on Apexigen’s business.

There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at containing or lowering the cost of healthcare. Apexigen cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect: