Palvella Therapeutics Inc 2024年度报告

Securities registered pursuant to Section 12(g) of the Act:None Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.Y☐N☒ Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act.Y☐N☒ Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.Y☒N☐ Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files).Y☒N☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growthcompany. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the ExchangeAct. Large accelerated filer☐Non-accelerated filer☒Emerging growth company☐ Accelerated filer☐Smaller reporting company☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financialaccounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financialreporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect thecorrection of an error to previously issued financial statements.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of theregistrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐ Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES☐NO☒ The aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant, based on the closing price of the Registrant’s Common Stock,as reported on the Nasdaq Capital Market on June 28, 2024, was $9.2million. DOCUMENTS INCORPORATED BY REFERENCE The registrant intends to file a definitive proxy statement pursuant to Regulation 14A within 120 days of the end of the fiscal year ended December 31, 2024. Portions of suchdefinitive proxy statement are incorporated by reference into Part III of this Annual Report on Form 10-K. TABLE OF CONTENTS PART I Item 1.BusinessItem 1A.Risk FactorsItem 1B.Unresolved Staff CommentsItem 1C.CybersecurityItem 2.PropertiesItem 3.Legal ProceedingsItem 4.Mine Safety Disclosures PART II Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of EquitySecurities99Item 6.[Reserved]99Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations100Item 7A.Quantitative and Qualitative Disclosures About Market Risk115Item 8.Financial Statements and Supplementary Data115Item 9.Changes in and Disagreements With Accountants on Accounting and Financial Disclosure115Item 9A.Controls and Procedures115Item 9B.Other Information116Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections116 PART III Item 10.Directors, Executive Officers and Corporate Governance117Item 11.Executive Compensation117Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters117Item 13.Certain Relationships and Related Transactions, and Director Independence117Item 14.Principal Accounting Fees and Services117 PART IV 118119 Item 15.Exhibits, Financial Statement SchedulesItem 16.Form 10-K Summary GENERAL INFORMATION Unless otherwise stated or the context requires otherwise, references in this Annual Report on Form 10-K to “Palvella,” the“company,” the “Company,” “we,” “us,” “our” or similar designations refer to Palvella Therapeutics, Inc. (formerly PierisPharmaceuticals, Inc.) and its subsidiaries, taken together. All trademarks, service marks, trade names and registered marks used inthis report are trademarks, trade names or registered marks of their respective owners. References to “Pieris” refer to Pieris Pharmaceuticals