Soligenix Announces Recent Accomplishments and Year End 2025 Financial Results

Rhea-AI Summary

Soligenix (Nasdaq: SNGX) reported 2025 results and program updates on March 31, 2026. The company ended 2025 with $7.9 million cash, a $11.1 million net loss, and highlighted key clinical milestones: a Q2 2026 interim analysis and H2 2026 top-line results for the Phase 3 HyBryte trial.

Regulatory progress includes EMA/EC orphan designation and UK Promising Innovative Medicine designation for dusquetide (SGX945); several publications and presentations were also announced.

Positive

• EMA/EC orphan designation granted for dusquetide (Behçet's Disease)
• UK PIM designation awarded for SGX945
• Phase 3 interim enrollment met: 50 of 80 patients enrolled for HyBryte interim analysis
• Blinded aggregate response in FLASH2 consistent and above study design estimate

Negative

• Net loss increased to $11.1M for 2025 (from $8.3M in 2024)
• Research & development expenses rose to $7.5M in 2025 (+44% vs 2024)
• Cash balance of $7.9M provides runway only into Q4 2026, indicating potential financing need

Key Figures

2025 Revenue: $0 2025 Net Loss: $11.1M 2025 EPS: ($2.14) per share +5 more

8 metrics

2025 Revenue $0 Year ended Dec 31, 2025 (vs $0.1M prior year)

2025 Net Loss $11.1M Year ended Dec 31, 2025 (vs $8.3M prior year)

2025 EPS ($2.14) per share Year ended Dec 31, 2025 (vs $4.98 loss prior year)

2025 R&D Expense $7.5M Year ended Dec 31, 2025 (vs $5.2M in 2024)

2025 G&A Expense $4.4M Year ended Dec 31, 2025 (vs $4.2M in 2024)

Year-end Cash $7.9M Cash position as of Dec 31, 2025; runway into Q4 2026

HyBryte FLASH2 Size 80 patients Confirmatory Phase 3 CTCL study planned enrollment

Interim Enrollment 50 patients Completed enrollment for interim analysis in FLASH2 trial

Market Reality Check

Price: $1.1100 Vol: Volume 174,338 vs 20-day ...

low vol

$1.1100 Last Close

Volume Volume 174,338 vs 20-day average 336,693 suggests muted trading interest into this release. low

Technical Shares at $1.11 trade below the 200-day MA of $1.68 and are 82.18% under the 52-week high.

Peers on Argus

Pre-news, SNGX was down 1.77% with below-average volume while momentum scanners ...

2 Up

Pre-news, SNGX was down 1.77% with below-average volume while momentum scanners flagged other biotech names like MBRX and IMRN moving up. Mixed moves across close peers, with some up and others down, point to stock-specific factors rather than a coordinated sector rotation.

Previous Earnings Reports

5 past events · Latest: Nov 07 (Neutral)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 07	Q3 2025 results	Neutral	+7.0%	Reported Q3 2025 loss, no revenue, HyBryte™ Phase 3 progress and cash runway.
Aug 14	Q2 2025 results	Neutral	+20.0%	Q2 2025 loss, cash position and ATM use, plus pipeline progress updates.
May 09	Q1 2025 results	Neutral	+0.5%	Q1 2025 loss, higher R&D spend, no revenue, and milestone outlook.
Mar 21	FY 2024 results	Neutral	+0.4%	Full-year 2024 loss, lower revenue, cash runway and HyBryte™ trial plans.
Nov 08	Q3 2024 results	Neutral	+0.9%	Q3 2024 loss, cash level and preparations for confirmatory HyBryte™ study.

Pattern Detected

Past earnings/financial updates have generally seen modestly positive price reactions, even when reporting net losses and cash-runway commentary.

Recent Company History

Over the last five earnings-style updates from Nov 2024 through Nov 2025, Soligenix consistently reported no or minimal revenue, ongoing net losses, and rising R&D tied to HyBryte™ and SGX945/SGX302 development. Cash balances fluctuated between roughly $5.1M and $10.5M, with runway typically extending about a year. Each update reinforced expectations for key HyBryte™ Phase 3 and SGX945/SGX302 readouts in 2025–2026, similar to the milestone framing in the current 2025 year-end results.

Historical Comparison

+5.8% avg move · Across the last 5 earnings-style releases, SNGX moved on average 5.76%. Investors have tended to rea...

earnings

+5.8%

Average Historical Move earnings

Across the last 5 earnings-style releases, SNGX moved on average 5.76%. Investors have tended to react modestly but positively to similar loss-making, milestone-focused financial updates.

Earnings updates have tracked steady progress of HyBryte™ toward confirmatory Phase 3 FLASH2 data in 2026 and advancement of SGX945 and SGX302 through Phase 2, while net losses and R&D spend rose alongside these late-stage development efforts.

Market Pulse Summary

This announcement combines 2025 financial results with a detailed milestone roadmap, including HyBry...

Analysis

This announcement combines 2025 financial results with a detailed milestone roadmap, including HyBryte™ Phase 3 FLASH2 interim data in Q2 2026 and top-line results in H2 2026. Investors may focus on the higher $11.1M net loss, increased R&D spending, and year-end cash of $7.9M supporting runway into Q4 2026. Tracking execution on HyBryte™, SGX945, and SGX302 timelines, as well as future financing steps, remains key.

Key Terms

orphan drug designation, phase 3, phase 2, phase 2a, +4 more

8 terms

orphan drug designation regulatory

"the European Commission... granted orphan drug designation to dusquetide"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

phase 3 medical

"confirmatory Phase 3 FLASH2 (Fluorescent Light And Synthetic Hypericin 2)"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

phase 2 medical

"plans to initiate a placebo-controlled Phase 2 study of SGX945"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

phase 2a medical

"the Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302"

Phase 2a is an early stage in testing a new medical treatment or drug, where the main goal is to assess its safety and find the right dosage. For investors, this stage indicates whether the treatment shows initial promise before moving on to larger, more definitive studies; progress here can influence expectations for future development and potential success.

placebo-controlled medical

"plans to initiate a placebo-controlled Phase 2 study of SGX945"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

investigator-initiated study medical

"conclusion of the zero-margin grant for the HyBryte™ investigator-initiated study"

An investigator-initiated study is a clinical or observational research project designed and run by independent researchers or clinicians rather than a company that makes the drug or device being tested. For investors, these studies act like an independent test drive: they can produce credible, additional evidence about safety, effectiveness or new uses that may change market expectations, influence prescribing, regulatory decisions, or the commercial value of a product.

cutaneous t-cell lymphoma medical

"for the treatment of early-stage cutaneous T-cell lymphoma (CTCL)"

Cutaneous T-cell lymphoma is a rare type of skin cancer that develops when certain immune system cells grow uncontrollably, causing skin patches, rashes, or tumors. While it primarily affects health, its rarity and complexity can influence medical research funding and pharmaceutical development, which may impact investment opportunities in healthcare and biotech sectors. Understanding such diseases helps investors gauge potential risks and innovations in medical treatments.

behçet's disease medical

"dusquetide (the active pharmaceutical ingredient in SGX945) for the treatment of Behçet's Disease"

A chronic inflammatory condition that causes recurring sores, eye inflammation and inflammation of blood vessels throughout the body, with symptoms and severity that vary widely between people. It matters to investors because the disease’s unpredictable course and need for long-term treatment shape the market for therapies, influence clinical trial design and regulatory approvals, and affect a company’s revenue and costs much like a customer base with irregular, high ongoing needs.

AI-generated analysis. Not financial advice.

Upcoming high-impact milestones include interim analysis in Q2 2026
and top-line results in H2 2026 from HyBryte™ trial

PRINCETON, N.J., March 31, 2026 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today its recent accomplishments and financial results for the year ended December 31, 2025.

"We are entering a pivotal year with several high-impact clinical and regulatory milestones across our rare disease pipeline," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Key among these milestones is the interim analysis from the confirmatory Phase 3 FLASH2 (Fluorescent Light And Synthetic Hypericin 2) clinical trial of HyBryte™ (SGX301 or synthetic hypericin) for the treatment of early-stage cutaneous T-cell lymphoma (CTCL) slated for the second quarter and the release of top-line results from this trial expected in the second half of 2026. The overall blinded aggregate response rate in this trial remains consistent with what was previously reported and is higher than the estimated overall response rate used to design the study, increasing our confidence in the interim analysis and final study results. Additionally, we are advancing our inflammatory disease programs, with plans to initiate a placebo-controlled Phase 2 study of SGX945 (dusquetide) for Behçet's Disease once formulation work for home-use administration is complete in the second half of 2026. We recently reported top-line results for the last cohort of four patients in the Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin), where SGX302 gel therapy demonstrated clincial benefit in improving psoriasis lesions and was well tolerated by all patients with no drug related adverse events identified."

Dr. Schaber continued, "Ending 2025 with approximately $7.9 million in cash, we remain focused on disciplined capital management to drive our strategic objectives. While our current cash balance provides operating runway into Q4 2026, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."

Soligenix Recent Accomplishments

• On March 26, 2026, the Company announced that the European Commission, acting on the positive recommendation from the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP), granted orphan drug designation to dusquetide (the active pharmaceutical ingredient in SGX945) for the treatment of Behçet's Disease. To view this press release, please click here.
• On March 23, 2026, the Company announced that findings from recent supportive trials with HyBryte™ in the treatment of CTCL are being presented at the United States Cutaneous Lymphoma Consortium Workshop. To view this press release, please click here.
• On March 19, 2026, the Company announced that a summary of clinical trials completed to date evaluating HyBryte™ as a treatment for CTCL has been published in the peer-reviewed medical journal Expert Opinion on Investigational Drugs. To view the publication, please click here. To view this press release, please click here.
• On March 10, 2026, the Company announced that SGX945 has been granted Promising Innovative Medicine designation in the United Kingdom by the Medicines and Healthcare Products Regulatory Agency for the treatment of Behçet's Disease. To view this press release, please click here.
• On February 26, 2026, the Company announced that the EMA COMP  provided a positive recommendation on the Company's request for orphan drug designation for dusquetide (the active pharmaceutical ingredient in SGX945) for the treatment of Behçet's Disease, following review of the recently published Phase 2a clinical results demonstrating biological efficacy and safety in patients with Behçet's Disease. To view this press release, please click here.
• On February 12, 2026, the Company issued an update letter detailing recent progress and upcoming milestones. To view this press release, please click here.
• On December 18, 2025, the Company announced that the results from its Phase 2a proof of concept study evaluating SGX945 in the treatment of Behçet's Disease have been published in Rheumatology (Oxford), in an article entitled "Results from a Pilot Study of Dusquetide for the Treatment of Aphthous Ulcers Associated with Behçet Syndrome". To view this press release, please click here.
• On December 17, 2025, the Company announced extended results of its ongoing Phase 2a trial of SGX302 for the treatment of mild-to-moderate psoriasis. To view this press release, please click here.
• On November 19, 2025, the Company announced it had completed the planned enrollment of 50 patients necessary for the interim analysis in its 80 patient confirmatory Phase 3 double-blind, placebo-controlled study evaluating HyBryte™ in the treatment of CTCL. To view this press release, please click here.

Financial Results – Quarter Ended December 31, 2025

Soligenix reported no revenues for the year ended December 31, 2025, compared to $0.1 million for the prior year. The decrease in revenues was primarily a result of the conclusion of the zero-margin grant for the HyBryte™ investigator-initiated study.

Soligenix's net loss was $11.1 million, or ($2.14) per share, for the year ended December 31, 2025, compared to $8.3 million, or ($4.98) per share, for the prior year. The increase in net loss is primarily attributed to increases in research and development costs associated with the Phase 2 study in Behçet's Disease, the ongoing second confirmatory Phase 3 CTCL study; a decrease in other income relating to tax credits; and the change in the fair value of debt.

Research and development expenses were $7.5 million as compared to $5.2 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily related to costs associated with the Phase 2 study in Behçet's Disease and the ongoing second confirmatory Phase 3 CTCL study.

General and administrative expenses were $4.4 million and $4.2 million for the years ended December 31, 2025 and 2024, respectively. This increase is primarily attributable to increases in various taxes and stock related expenses offset by a decrease in professional fees.

As of December 31, 2025, the Company's cash position was approximately $7.9 million.

About Soligenix, Inc.

Soligenix is a late-stage 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 and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behçet's Disease.

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 Twitter 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, 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. 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. Despite the statistically significant result achieved in the first HyBryte™ (SGX301) Phase 3 clinical trial for the treatment of cutaneous T-cell lymphoma or any other studies (including the open-label, investigator-initiated study) and the overall blinded aggregate response rate observed in the second HyBryte™ (SGX301) Phase 3 clinical trial, there can be no assurance that the second HyBryte™ (SGX301) Phase 3 clinical trial will be successful or that a marketing authorization from the FDA or EMA will be granted. Additionally, although the EMA has agreed to the key design components of the second HyBryte™ (SGX301) Phase 3 clinical trial, no assurance can be given that the Company will be able to modify the development path to adequately address the FDA's concerns or that the FDA will not require a longer duration comparative study. Notwithstanding the result in the first HyBryte™ (SGX301) Phase 3 clinical trial 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.

FAQ

When will Soligenix (SNGX) report the interim analysis and top-line results for HyBryte Phase 3 FLASH2?

The interim analysis is expected in Q2 2026, with top-line results due in H2 2026. According to the company, the study reached the 50-patient threshold required for the planned interim review, and the blinded aggregate response remains consistent with design assumptions.

What does the EU orphan designation for dusquetide mean for Soligenix (SNGX)?

EU orphan designation may provide regulatory incentives and exclusivity benefits for dusquetide in Behçet's Disease. According to the company, the designation followed a positive EMA COMP recommendation and supports development and potential market exclusivity.

How strong is Soligenix's cash runway after the 2025 results (SNGX)?

Soligenix ended 2025 with approximately $7.9 million in cash, projected to fund operations into Q4 2026. According to the company, management is evaluating partnerships, grants, and financing to advance the late-stage pipeline beyond that runway.

Why did Soligenix (SNGX) report a larger net loss in 2025 versus 2024?

Net loss rose to $11.1 million in 2025 from $8.3 million in 2024 primarily due to higher R&D spend and lower other income. According to the company, increases were tied to ongoing Phase 3 CTCL and Phase 2 Behçet's Disease programs.

What clinical progress was reported for SGX302 and SGX945 in the March 31, 2026 Soligenix update (SNGX)?

SGX302 showed clinical benefit and good tolerability in a Phase 2a psoriasis cohort, while SGX945 advanced toward Phase 2 in Behçet's Disease. According to the company, SGX302 had no drug-related adverse events and SGX945 received regulatory designations supporting development.