Pyxis Oncology Inc 2025年季度报告

☒☐☐☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition periodfor complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the ExchangeAct.☒Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes☐No☒As of May 14, 2025, the registrant had 61,947,665 shares of common stock, $0.001 par value per share, outstanding.Table of ContentsPageSummary Risk Factors1PARTI.FINANCIAL INFORMATION2Item 1.Financial Statements (Unaudited)2Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 20242Condensed Consolidated Statements of Operations and Comprehensive Loss for the Three MonthsEnded March 31, 2025 and 20243Condensed Consolidated Statements of Stockholders’ Equity for the Three Months Ended March 31,2025 and 20244Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2025 and20245Notes to Condensed Consolidated Financial Statements6Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations15Item 3.Quantitative and Qualitative Disclosures About Market Risk24Item 4.Controls and Procedures24PARTII.OTHER INFORMATION25Item 1.Legal Proceedings25Item1A.Risk Factors25Item 2.Unregistered Sales of Equity Securities and Use of Proceeds61Item 3.Defaults Upon Senior Securities61Item 4.Mine Safety Disclosures61Item 5.Other Information61Item 6.Exhibits62Signatures63i SUMMARY RISK FACTORSYou should consider carefully the risks described under “Risk Factors” in Part II, Item 1A of thisQuarterly Report on Form 10-Q. References to “Pyxis Oncology,” the “Company,” “we,” “us,” and “our” in thissection titled “Summary Risk Factors” refer to Pyxis Oncology, Inc. and its wholly owned subsidiaries. Asummary of the risks that could materially and adversely affect our business, financial condition, operatingresults and prospects include the following:•We are a clinical stage oncology company with a limited operating history and have incurred significant lossessince our inception and anticipate that we will continue to incur losses over at least the next several years andmay never achieve or maintain profitability.•We will require substantial additional capital to finance our operations. If we are unable to raise such capitalwhen needed, or on acceptable terms, we may be forced to delay, reduce or eliminate one or more of our researchand product development programs or future commercialization efforts.•We are heavily dependent on the success of our product candidate, micvotabart pelidotin, which is in the earlystages of clinical development. If our product candidate is not successful in clinical trials or does not receiveregulatory approval or licensure or is not successfully commercialized, our business will be materially and•Our product candidate may fail in development or suffer delays that materially and adversely affect itscommercial viability. If we or our existing or future collaborators are unable to initiate and complete clinicaldevelopment of, obtain regulatory approval or licensure for or commercialize our product candidate or experiencesignificant delays in doing so, our business will be materially harmed.•Our product candidate may cause undesirable and unforeseen side effects or have other properties impactingsafety that could halt its clinical development, delay or prevent its regulatory licensure, limit its commercialpotential or result in significant negative consequences.•We face significant competition from other biotechnology and pharmaceutical entities, and our operating resultswill suffer if we fail to compete effectively.•Clinical testing and product development is a lengthy and expensive process with an uncertain outcome. Wemay incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the clinicaltesting and the development and commercialization of our product candidate.•The regulatory licensure and approval processes of the FDA and other comparable foreign regulatory authoritiesare lengthy, time-consuming and inherently unpredictable and, if we are unable to obtain marketing licensure orapproval for our product candidate, our business will be substantially harmed.•If we fail to attract and retain qualified senior management and key scientific personnel, our business may be•We rely on third parties to manufacture our product candidate. Any failure by a third party manufacturer toproduce acceptable raw materials or product candidate for us or to obtain authorization from the FDA orcomparable foreign regulatory authorities relating thereto may delay or impair our ability to initiate or completeour clinical trials, obtain regulatory licensure or approvals or commercialize approved products.•If we are unable to obtain or protect our intellectual property in and to our product candidates, we may not beable to compete effectively in ou