Soligenix Inc 2025年季度报告

FORM10-Q QUARTERLY REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF1934 ☒ For the Quarterly Period EndedSeptember 30, 2025 or ☐TRANSITION REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF1934 For the transition period from ____________ to ____________ Commission File No.001-14778 SOLIGENIX,INC.(Exact name of registrant as specified in its charter) (Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Common Stock, par value $.001per share Indicate by check whether the registrant (1)filed all reports required to be filed by Section13 or 15(d)of theSecurities Exchange Act of 1934 during the preceding 12months (or for such shorter period that the registrant wasrequired to file such reports), and (2)has been subject to such filing requirements for the past 90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to besubmitted pursuant to Rule405 of Regulation S-T during the preceding 12months (or for such shorter period that theregistrant was required to submit such files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-acceleratedfiler, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,”“accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extendedtransitionperiod for complying with any new or revised financial accounting standards provided pursuant toSection13(a)of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act).Yes☐No☒ As of October 31, 2025,10,086,130shares of the registrant’s common stock (par value, $.001 per share) wereoutstanding. SOLIGENIX,INC. Index DescriptionPage PartIFINANCIAL INFORMATION1 Item1Condensed Consolidated Financial Statements (unaudited)1Condensed Consolidated Balance Sheets as of September 30, 2025 andDecember31, 20241Condensed Consolidated Statements of Operations for the Three and NineMonths Ended September 30, 2025 and 20242Condensed Consolidated Statements of Comprehensive Loss for the Threeand Nine Months Ended September 30, 2025 and 20243Condensed Consolidated Statements of Changes in Shareholders’ Equityfor the Nine Months Ended September 30, 2025 and 20244Condensed Consolidated Statements of Changes in Shareholders’ Equityfor the Three Months Ended September 30, 2025 and 20245Condensed Consolidated Statements of Cash Flows for the NineMonthsEnded September 30, 2025 and 20246Notesto Condensed Consolidated Financial Statements7Item2Management’s Discussion and Analysis of Financial Condition and Results ofOperations20Item3Quantitative and Qualitative Disclosures About Market Risk46Item4Controls and Procedures46 PartIIOTHER INFORMATION Item1Legal Proceedings46Item1ARisk Factors46Item 2Unregistered Sales of Equity Securities and Use of Proceeds47Item5Other Information47Item6Exhibits48 PARTI- FINANCIAL INFORMATION ITEM1- FINANCIAL STATEMENTS Soligenix, Inc. and SubsidiariesCondensed Consolidated Balance Sheets The accompanying notes are an integral part of these condensed consolidated financialstatements. Soligenix,Inc. and SubsidiariesCondensed Consolidated Statements of Changes in Shareholders’ EquityFor the Nine Months Ended September 30, 2025 and 2024(Unaudited) Soligenix,Inc. and SubsidiariesCondensed Consolidated Statements of Changes in Shareholders’ EquityFor the Three Months Ended September 30, 2025 and 2024(Unaudited) Soligenix,Inc. and SubsidiariesCondensed Consolidated Statements of Cash FlowsFor the Nine Months Ended September 30, 2025 and 2024(Unaudited) Soligenix,Inc. and SubsidiariesNotesto Condensed Consolidated Financial Statements(Unaudited) Note1. Nature of Business Basis of Presentation Soligenix,Inc.(the“Company”)is a late-stage biopharmaceutical company focused ondeveloping and commercializing products to treat rare diseases where there is an unmet medicalneed. The Company maintainstwoactive business segments: Specialized BioTherapeutics andPublic Health Solutions. TheCompany’s Specialized BioTherapeutics business segment is developing and movingtoward potential commercialization of HyBryte™ (a proposed proprietary name of SGX301 orsynthetic hypericin sodium), a novel photodynamic therapy utilizing topical synthetic hypericinactivated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). Withsuccessfulcompletion of the first Phase 3 FLASH(Fluorescent Light Activated SyntheticHypericin) study and agreement from the European Medicines Agency (“EMA”) on the keydesign components of a confirmatory Phase 3 placebo-controlled study evaluating the safetyand efficacy of HyBryte™ in th