{"url_path":"/sec/sngx/8-k/2026-06-12/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 ****Other Events.**","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-12","source_url":"https://www.sec.gov/Archives/edgar/data/812796/0001104659-26-073430-index.html","accession_number":"0001104659-26-073430","cik":"0000812796","ticker":"SNGX","issuer_name":"SOLIGENIX, INC.","edgar_url":"https://www.sec.gov/Archives/edgar/data/812796/0001104659-26-073430-index.html","primary_entity_key":"0000812796","primary_entity_name":"SOLIGENIX, INC."},"word_count":621,"has_tables":true,"body_markdown":"**Item 8.01****Other Events.**\n\n \n\nTermination of the HyBryte™ Development Program\n\n​\n\nAs previously reported in the Company’s Current Report on Form 8-K filed on April 28, 2026, the Data Monitoring Committee (the “DMC”) completed an interim efficacy analysis of the Company’s confirmatory Phase 3 FLASH2 (Fluorescent Light Activated Synthetic Hypericin 2) clinical trial evaluating HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma and recommended that the study be halted for futility.  Following a thorough\n\n2\n\nreview of the DMC’s recommendation and evaluation of the program’s path forward, on June 11, 2026, the Company’s Board of Directors determined that it is in the best interest of the Company and its stockholders to terminate the HyBryte™ development program.\n\n​\n\nThe Company will undertake an orderly wind-down of the FLASH2 trial and related HyBryte™ development activities. The Company estimates that it will incur approximately $70,000 in charges in connection with the wind-down of the HyBryte™ program, consisting primarily of clinical trial close-out costs and related expenses.\n\n​\n\nThe Company intends to continue to evaluate all strategic options moving forward, including but not limited to merger and acquisition opportunities, as well as the potential of advancing its other pipeline programs, including dusquetide (SGX945) for the treatment of Behçet’s Disease, which has received orphan drug designation from the U.S. Food and Drug Administration, orphan drug designation from the European Commission, and Promising Innovative Medicine designation from the UK Medicines and Healthcare products Regulatory Agency.\n\n​\n\nSafe Harbor for Forward-Looking Statements\n\n​\n\n*Certain statements contained in this report may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements containing the words “predicts,” “plans,” “expects,” “anticipates,” “believes,” “goal,” “target,” “estimate,” “potential,” “may,” “might,” “could,” “see,” “seek,” “forecast,” and similar words.  Forward-looking statements are based on the Company’s current plans and expectations and involve risks and uncertainties which are, in many instances, beyond the Company’s control, and which could cause actual results to differ materially from those included in or contemplated or implied by the forward-looking statements.  Such risks and uncertainties include, among others, the Company’s ability to regain compliance with the Nasdaq Listing Rule 5550(a)(2) minimum bid price requirement within the applicable compliance period, the potential delisting of the Company’s common stock from The Nasdaq Capital Market and the potential adverse effects of such delisting on the trading price and liquidity of the Company’s common stock, the Company’s ability to satisfy the requirements for a second compliance period, the uncertainty of identifying, evaluating and completing strategic transactions, including merger and acquisition opportunities, on favorable terms or at all, the ability of the Company to successfully advance its alternative pipeline programs, including dusquetide (SGX945) for the treatment of Behçet’s Disease, the sufficiency of the Company’s capital resources to fund operations and pursue strategic alternatives, and the other risks, uncertainties and factors detailed in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including in the Company’s Annual Report for the year ended December 31, 2025 on Form 10-K, which was filed with the SEC, and in other periodic reports on Form 10-Q and Form 8-K. As a result of such risks, uncertainties and factors, the Company’s actual results may differ materially from any future results, performance or achievements discussed in or implied by the forward-looking statements contained herein.  The Company is providing the information in this report as of the date hereof and assumes no obligations to update the information included in this report or revise any forward-looking statements, whether as a result of new information, future events or otherwise.*\n\n​"}