PRINCETON, N.J., Aug. 7, 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 June 30, 2026.
"While we were disappointed with the outcome of the Phase 3 FLASH2 clincial study that led to discontinuing the HyBryte™ (synthetic hypericin) development program, this outcome does not diminish the strength of our broader pipeline or the strategic value of Soligenix," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We remain focused on evaluating opportunities across our diversified portfolio, including the continued advancement of SGX945 (dusquetide) for Behçet's disease, which demonstrated promising preliminary efficacy and was generally safe and well-tolerated in our Phase 2 study, as well as our ThermoVax® heat-stable vaccine platform."
"With approximately $9.8 million in cash as of June 30, 2026, providing cash runway into the second quarter of 2028, we are well positioned to actively evaluate all strategic options to maximize stockholder value, including but not limited to partnerships, licensing opportunities, merger and acquisition opportunities, government grants and contracts, and the advancement of 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. Consistent with this strategy, we are contuning to seek non-dilutive funding support for the development of our heat-stable Bundibugyo Ebola vaccine program from various sources, including the Coalition for Epidemic Preparedness Innovations (CEPI) and others."
Soligenix Recent Updates
- On June 8, 2026, the Company announced that along with the University of Hawaiʻi at Mānoa, it would be applying for CEPI funding to develop a protein-based, thermostable vaccine targeting the Bundibugyo virus by leveraging the thermostability, immunogenicity, and efficacy data demonstrated with its filovirus vaccines. To view this press release, please click here.
- On May 26, 2026, in response to a recent Bundibugyo virus outbreak in the Congo, the Company highlighted previous work with the University of Hawaiʻi, which has demonstrated platform compatibility with the key Bundibugyo virus antigen enabling rapid development of a protein-based thermostable subunit vaccine. To view this press release, please click here.
Financial Results – Quarter Ended June 30, 2026
Soligenix had no revenue for the quarter ended June 30, 2026 and 2025, respectively.
Soligenix's net loss was $2.0 million, or ($0.12) per share, for the quarter ended June 30, 2026, compared to $2.7 million, or ($0.82) per share, for the same prior year period. This decrease in net loss was primarily due to a decrease in in research and development expenses associated with the terminated FLASH2 trial and related HyBryte™ development activities.
Research and development expenses were $1.0 million as compared to $1.7 million for the quarter ended June 30, 2026 and 2025, respectively. 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 $1.1 million for the quarter ended June 30, 2026 as compared to $1.1 million for the same period in 2025, relatively flat with a de minimis increase.
As of June 30, 2026, the Company's cash position was approximately $9.8 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). We were developing HyBryte™ (SGX301 or synthetic hypericin sodium), a photodynamic therapy utilizing visible light, for the treatment of cutaneous T-cell lymphoma (CTCL) in a Phase 3 study called "FLASH2" (Fluorescent Light Activated Synthetic Hypericin 2). The Data Monitoring Committee completed its interim efficacy analysis of the FLASH2 trial during April 2026, and under the terms of the interim analysis, the study was recommended to halt for futility. In June 2026, following a thorough review of the Data Monitoring Committee's recommendation and evaluation of the program's path forward, our Board of Directors determined that it was in our best interest and the interest of our stockholders to terminate the HyBryte™ development program.
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) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). 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. Statements that are not historical facts, 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. The Company's submission of an application for funding from CEPI for Bundibugyo virus vaccine development is preliminary in nature and there can be no assurance that CEPI will select the Company's application for funding, that the Company will receive any funding from CEPI, or that any such funding, if received, will be sufficient to advance the Company's vaccine development programs. The Company does not intend to provide updates regarding the status of its CEPI application unless and until a material development occurs, such as the receipt of a funding award. The failure to receive CEPI funding would not, standing alone, constitute a material event requiring further disclosure, as the Company has not previously received the CEPI funding and would not be losing an existing funding source. In light of the discontinuation of the FLASH2 study, 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 result of HyBryte™ (SGX301) in the first Phase 3 clinical trial (or any other studies) for the treatment of cutaneous T-cell lymphoma and 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. 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 reports on Forms 10-Q and 10-K. 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.
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SOURCE SOLIGENIX, INC.
