PRINCETON, N.J., Nov. 6, 2026 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent updates and financial results for the quarter ended September 30, 2026.
"We are continuing to pursue all strategic options to maximize stockholder value, including within our own rare disease portfolio. This includes advancement of SGX945 (dusquetide) for Behçet's disease, which showed encouraging signs of biological activity and was generally safe and well-tolerated in a small, open-label Phase 2a proof-of-concept study, as well as our ThermoVax® heat-stable vaccine platform," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With approximately $9.0 million in cash and cash equivalents as of September 30, 2026, which we believe is sufficient to fund our current operating plan into the second quarter of 2028, we are evaluating a number of potential opportunities, including but not limited to partnership, licensing, merger and acquisition, government grants and contracts, while advancing our existing pipeline. Maintaining our Nasdaq listing is also an important strategic asset that supports these efforts by preserving access to the public capital markets, enhancing our attractiveness to potential strategic partners and acquirers, and providing additional flexibility as we evaluate these opportunities."
Financial Results – Quarter Ended September 30, 2026
Soligenix had no revenue for the quarters ended September 30, 2026 and 2025.
Soligenix's net loss was $1.1 million, or ($0.05) per share, for the quarter ended September 30, 2026, compared to $2.5 million, or ($0.58) per share, for the same prior year period. This decrease in net loss was primarily due to a decrease in research and development expenses associated with the terminated FLASH2 trial and related HyBryte™ development activities, and a gain on extinguishment of vendor liabilities.
Research and development expenses were $0.4 million for the quarter ended September 30, 2026, as compared to $1.6 million for the same period in 2025. The decrease was primarily due to decreases in costs associated with the terminated FLASH2 trial and related HyBryte™ development activities.
General and administrative expenses were $1.0 million for the quarter ended September 30, 2026 as compared to $1.0 million for the same period in 2025, relatively flat with a de minimis increase.
As of September 30, 2026, the Company had cash and cash equivalents of approximately $9.0 million.
About Soligenix, Inc.
Soligenix is a biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing synthetic hypericin for the treatment of psoriasis (SGX302), and our first-in-class Innate Defense Regulator (IDR) technology, dusquetide, for the treatment of inflammatory diseases, including aphthous ulcers in Behçet's Disease (BD) (SGX945) and oral mucositis in head and neck cancer (SGX942).
Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit the Company's website at https://www.soligenix.com and follow us on LinkedIn and X at @Soligenix_Inc.
This press release may contain forward-looking statements that reflect Soligenix's current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations and clinical trial enrollment, the sufficiency of our cash resources and expected cash runway, our evaluation and potential pursuit of strategic alternatives, and our ability to regain compliance with Nasdaq continued listing requirements. Statements that are not historical facts, including statements containing words such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, and include the expected timing and results of clinical trials and the expected timing of regulatory submissions and approvals. In light of the termination of the FLASH2 study and the HyBryte™ development program, the Company's ability to continue as a going concern will be dependent upon its ability to develop and commercialize its remaining pipeline assets, including dusquetide for the treatment of Behçet's Disease, to identify and acquire or in-license additional product candidates or technologies, and to raise sufficient capital to fund such development and any such acquisitions. There can be no assurance that the Company will be able to obtain financing on acceptable terms, if at all, that suitable acquisition or in-licensing opportunities will be available, or that any of its remaining or future development programs will be successful. If the Company is unable to raise sufficient capital or otherwise advance its remaining assets, it may be required to significantly curtail or cease its operations, sell or otherwise dispose of its assets, or pursue dissolution and liquidation. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the U.S. Government or other countries, that it will be able to compete with larger and better financed competitors in the biotechnology industry, that changes in health care practice, third party reimbursement limitations and Federal and/or state health care reform initiatives will not negatively affect its business, or that the U.S. Congress may not pass any legislation that would provide additional funding for the Project BioShield program. In addition, there can be no assurance as to the timing or success of any of its clinical/preclinical trials. Notwithstanding the results observed to date in the Phase 2a clinical trial of SGX302 for the treatment of psoriasis, there can be no assurance as to the timing or success of the clinical trials of SGX302 for the treatment of psoriasis. Additionally, despite the biologic activity observed in aphthous ulcers induced by chemotherapy and radiation, there can be no assurance as to the timing or success of the clinical trials of SGX945 for the treatment of Behçet's Disease. Further, there can be no assurance that RiVax® will qualify for a biodefense Priority Review Voucher (PRV) or that the prior sales of PRVs will be indicative of any potential sales price for a PRV for RiVax®. Also, no assurance can be provided that the Company will receive or continue to receive non-dilutive government funding from grants and contracts that have been or may be awarded or for which the Company will apply in the future. There can be no assurance that the Company will identify or consummate any strategic transaction, or that any such transaction will enhance stockholder value. There can be no assurance that the Company will regain compliance with the Nasdaq minimum bid price requirement or continue to satisfy other Nasdaq continued listing requirements, including the minimum market value of listed securities requirement if it becomes operative, and any delisting of the Company's common stock could adversely affect its liquidity and the Company's ability to raise capital. These and other risk factors are described from time to time in filings with the Securities and Exchange Commission (the "SEC"), including, but not limited to, Soligenix's Annual Report on Form 10-K for the year ended December 31, 2025 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2026. Unless required by law, Soligenix assumes no obligation to update or revise any forward-looking statements as a result of new information or future events.
SOURCE SOLIGENIX, INC.