Positive Clinical Results from HyBryte™ Comparative Study Evaluating HyBryte™ Against Valchlor® in the Treatment of Cutaneous T-Cell Lymphoma Published in Oncology and Therapy

Rhea-AI Summary

Soligenix (Nasdaq: SNGX) reported that a 12-week comparability study of HyBryte (synthetic hypericin) versus Valchlor showed faster, more robust responses and a benign safety profile for HyBryte.

At 12 weeks, 60% of HyBryte patients met the predefined treatment success (≥50% mCAILS improvement) versus 20% for Valchlor; mean mCAILS improvement was 52.5% vs 34.7%. HyBryte had no therapy-related adverse events; Valchlor had related AEs in 60% and one withdrawal for allergic contact dermatitis.

AI-generated analysis. Not financial advice.

Positive

• 60% treatment success (≥50% mCAILS) at 12 weeks for HyBryte
• Mean mCAILS improvement 52.5% for HyBryte versus 34.7% for Valchlor
• No therapy-related adverse events reported in HyBryte-treated patients

Negative

• Small sample size prevented statistical significance of comparative results
• Randomization imbalance left HyBryte group with more extensive disease at baseline

News Market Reaction – SNGX

-0.87%

2 alerts

-0.87% News Effect

-$102K Valuation Impact

$11.60M Market Cap

0.0x Rel. Volume

On the day this news was published, SNGX declined 0.87%, reflecting a mild negative market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $102K from the company's valuation, bringing the market cap to $11.60M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

HyBryte treatment success: 60% Valchlor treatment success: 20% HyBryte mCAILS improvement: 52.5% +5 more

8 metrics

HyBryte treatment success 60% Patients achieving ≥50% mCAILS improvement at 12 weeks

Valchlor treatment success 20% Patients achieving ≥50% mCAILS improvement at 12 weeks

HyBryte mCAILS improvement 52.5% Average cumulative mCAILS improvement at 12 weeks

Valchlor mCAILS improvement 34.7% Average cumulative mCAILS improvement at 12 weeks

Valchlor treatment-related AEs 60% of patients Valchlor patients with at least one therapy-related adverse event

HyBryte treatment-related AEs 0 patients HyBryte group with adverse events related to therapy

Treatment duration 12 weeks Comparative HyBryte vs Valchlor CTCL study period

Index lesions assessed 3–5 per patient Prospectively identified CTCL lesions evaluated for response

Market Reality Check

Price: $0.3900 Vol: Volume 163,802 is below t...

low vol

$0.3900 Last Close

Volume Volume 163,802 is below the 20-day average of 345,728 (relative volume 0.47). low

Technical Shares at $1.15 are trading below the $1.67 200-day MA, about 81.54% under the 52-week high and 15% above the 52-week low of $1.00.

Peers on Argus

SNGX was down 2.54% while momentum scans only flagged biotech peer IMRN up 5.91%...

1 Up

SNGX was down 2.54% while momentum scans only flagged biotech peer IMRN up 5.91%. Other listed peers show mixed single‑stock moves, suggesting today’s action in SNGX is stock‑specific rather than a coordinated sector rotation.

Previous Clinical trial Reports

5 past events · Latest: Mar 26 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 26	Orphan designation granted	Positive	+0.8%	EU orphan drug designation for SGX945 in Behçet's Disease.
Feb 26	EMA orphan opinion	Positive	-2.5%	Positive EMA opinion recommending orphan status for SGX945.
Dec 18	Phase 2a results	Positive	+0.0%	Publication of SGX945 Phase 2a Behçet's results showing clinical benefit.
Nov 19	HyBryte enrollment update	Positive	-3.6%	FLASH2 interim enrollment milestone and higher-than-expected blinded response rate.
Oct 07	HyBryte safety milestone	Positive	+19.7%	DMC review finding no safety concerns in Phase 3 FLASH2 trial.

Pattern Detected

Clinical and regulatory updates have often produced mixed reactions, with both strong rallies and selloffs on otherwise positive trial or designation news.

Recent Company History

Recent history shows a steady stream of positive clinical and regulatory milestones. Prior clinical‑trial‑tagged events include Phase 2 data for SGX945, EMA and EC steps toward orphan status, and HyBryte™ Phase 3 safety and enrollment milestones in 4Q 2025–1Q 2026. Price reactions ranged from a 19.71% gain on a HyBryte safety milestone to declines after favorable EMA opinions, indicating that even encouraging updates do not consistently translate into upside.

Historical Comparison

+2.9% avg move · Clinical-trial news for SNGX has historically led to modest average moves of 2.87%, with both rallie...

clinical trial

+2.9%

Average Historical Move clinical trial

Clinical-trial news for SNGX has historically led to modest average moves of 2.87%, with both rallies and declines. Today’s publication-led update and its -2.54% move fit this mixed reaction pattern.

The clinical-trial history shows progression from SGX945 Phase 2 data through EMA and EC orphan milestones, alongside HyBryte™ Phase 3 safety and enrollment achievements, underscoring advancing programs in both CTCL and Behçet’s Disease.

Market Pulse Summary

This announcement highlights that HyBryte™ achieved a 60% treatment success rate and greater average...

Analysis

This announcement highlights that HyBryte™ achieved a 60% treatment success rate and greater average mCAILS improvement than Valchlor®, with notably fewer treatment-related adverse events. The data add to a series of publications and Phase 3 updates positioning HyBryte™ in CTCL. Investors may watch upcoming FLASH2 interim results, longer-duration outcomes, and future regulatory interactions to gauge how these comparative findings translate into the broader development path.

Key Terms

cutaneous t-cell lymphoma, mechlorethamine, index lesions, allergic contact dermatitis, +2 more

6 terms

cutaneous t-cell lymphoma medical

"for the treatment of cutaneous T-cell lymphoma (CTCL) have been published"

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.

mechlorethamine medical

"HyBryte™ (synthetic hypericin) versus Valchlor® (mechlorethamine) for the treatment"

Mechlorethamine is a chemotherapy drug that works by damaging the DNA of rapidly dividing cells, causing cancer cells to stop multiplying. Investors care because its approval, production, supply, or safety issues can materially affect a drugmaker’s sales, regulatory risk, manufacturing costs, and legal exposure; think of it as a specialist tool whose availability and reputation can change a company’s projected earnings and market value.

index lesions medical

"measured in 3 to 5 prospectively identified index lesions for each patient"

Index lesions are the specific tumor or disease sites selected at the start of a clinical study to track how a treatment affects a patient’s condition. They matter to investors because these predefined targets provide a consistent, measurable way to judge a drug’s effectiveness and safety—similar to monitoring a few representative trees to estimate the health of an entire forest—and their outcomes often drive trial results, regulatory decisions, and commercial prospects.

allergic contact dermatitis medical

"withdrawn from the trial because of a clinically significant allergic contact dermatitis"

Allergic contact dermatitis is a skin reaction that happens when a person’s immune system becomes sensitized to a substance and then reacts with redness, itching, blisters or a rash after skin contact. Think of the skin as a smoke alarm that, once triggered by a particular chemical, will react strongly each time it encounters it. For investors it matters because outbreaks, product recalls, regulatory restrictions or rising treatment costs can hurt sales, trigger liability claims, affect supply chains and change healthcare or workplace expense forecasts.

dermatitis medical

"events in the Valchlor® group included rashes, application site sensitivity, allergic contact dermatitis, and dermatitis"

Dermatitis is inflammation of the skin that causes redness, itching, swelling or blisters—think of it like the skin reacting badly to an irritant, allergy or moisture imbalance. For investors, dermatitis matters because its prevalence drives demand for prescription drugs, over‑the‑counter treatments, skincare products and related clinical trials or regulatory approvals, all of which can affect sales, research spending and the valuation of healthcare and consumer goods companies.

adverse events medical

"all patients tolerated HyBryte™ well and had no adverse events "related" to the therapy"

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

AI-generated analysis. Not financial advice.

HyBryte™ demonstrates more rapid and robust treatment response compared to
Valchlor^® during 12-week treatment course

PRINCETON, N.J., April 2, 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 that the positive results of its comparability study evaluating HyBryte™ (synthetic hypericin) versus Valchlor^® (mechlorethamine) for the treatment of cutaneous T-cell lymphoma (CTCL) have been published in Oncology and Therapy. 

"Being able to share the important results of this clinical trial with the world through publication in Oncology and Therapy is a privilege and highlights the clinical significance of our work with HyBryte™," stated Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group, Fairport, NY, and Principal Investigator for the comparability study. "Despite the small study sample size and a randomization that lead to the HyBryte™ group having patients with more extensive disease, HyBryte™ performed well and the results are consistent with previous studies demonstrating its rapid onset of action and benign safety profile compared to one of the most widely prescribed approved drugs for early-stage CTCL. The positive effect this therapy can have for patients and the outstanding safety profile that HyBryte™ continues to demonstrate are very encouraging."

The purpose of the study was to obtain preliminary comparative assessment of the safety and efficacy of HyBryte™ versus Valchlor^® following 12 weeks of treatment as measured in 3 to 5 prospectively identified index lesions for each patient. At the end of the 12-week treatment period, 60% of the HyBryte™ patients met the prospectively defined level of "Treatment Success" (≥50% improvement in their cumulative mCAILS score compared to Baseline) compared to only 20% of the Valchlor^® patients; although due to the small sample size the results do not achieve statistical significance. Of the remaining two HyBryte™ patients that did not achieve treatment success, both saw a substantial (≥30%) reduction in their mCAILS score. In contrast, in the Valchlor^® group, of the remaining 4 patients that did not achieve treatment success, one worsened and dropped from the study, one improved less than 30% and two improved greater than 30%. The average cumulative improvement in mCAILS at 12 weeks was 52.5% in the HyBryte™ patients versus 34.7% in the Valchlor^® patients. HyBryte™ was well tolerated in all patients whereas 1 of the 5 patients receiving Valchlor^® had to be withdrawn from the trial because of a clinically significant allergic contact dermatitis from Valchlor^®.

When comparing the tolerance of the topical therapies (i.e., reactions where the drug was applied to the skin) in this trial, it is notable that all patients tolerated HyBryte™ well and had no adverse events "related" to the therapy. In contrast, 60% of the Valchlor^® treated patients had at least one adverse event "related" to the therapy. These adverse events in the Valchlor^® group included rashes, application site sensitivity, allergic contact dermatitis, and dermatitis, with one patient requiring steroid treatment, one requiring temporary interruption of Valchlor^® treatment, and one requiring permanent discontinuation of Valchlor^®. No such instances were reported in the HyBryte™ group.

About Oncology and Therapy

Oncology and Therapy is an international, open access, peer-reviewed, and rapid publication journal. The scope of the journal is broad, dedicated to the publication of high-quality clinical, observational, real-world, patient care, and health outcomes research around the discovery, development, and use of therapeutics and interventions across all areas of oncology. The key features of the journal are rapid publication, open access, inclusivity, personal service, digital features, plain language summaries and novel article types.

About HyBryte™

HyBryte™ (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte™ has received orphan drug and fast track designations from the FDA, as well as orphan designation from the European Medicines Agency (EMA).

The published Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle (Cycle 1), 116 patients received HyBryte™ treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the modified Composite Assessment of Index Lesion Severity [mCAILS] score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte™ treatment in this cycle was safe and well tolerated.

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte™ treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte™ treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte™ treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p<0.0001 vs the placebo treatment rate in Cycle 1). Comparison of the 12-week and 6-week treatment responses also revealed a statistically significant improvement (p<0.0001) between the two timepoints, indicating that continued treatment results in better outcomes. HyBryte™ continued to be safe and well tolerated. Additional analyses also indicated that HyBryte™ is equally effective in treating both plaque (response 42%, p<0.0001 relative to placebo treatment in Cycle 1) and patch (response 37%, p=0.0009 relative to placebo treatment in Cycle 1) lesions of CTCL, a particularly relevant finding given the historical difficulty in treating plaque lesions.

The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte™ treatment of all their lesions. Of note, 66% of patients elected to continue with this optional compassionate use / safety cycle of the study. Of the subset of patients that received HyBryte™ throughout all 3 cycles of treatment, 49% of them demonstrated a positive treatment response (p<0.0001 vs patients receiving placebo in Cycle 1). Moreover, in a subset of patients evaluated in this cycle, it was demonstrated that HyBryte™ is not systemically available, consistent with the general safety of this topical product observed to date. At the end of Cycle 3, HyBryte™ continued to be well tolerated despite extended and increased use of the product to treat multiple lesions.

Overall safety of HyBryte™ is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte's™ mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant, and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte™ potentially represents the safest available efficacious treatment for CTCL. With very limited systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.

Following the first Phase 3 study of HyBryte™ for the treatment of CTCL, the FDA and the EMA indicated that they would require a second successful Phase 3 trial to support marketing approval. With agreement from the EMA on the key design components, the second, confirmatory study, called FLASH2, has successfully achieved its first safety review milestone with a pre-specified, blinded interim analysis expected to be completed in 2Q2026. This study is a randomized, double-blind, placebo-controlled, multicenter study that will enroll approximately 80 subjects with early-stage CTCL. The FLASH2 study replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study that consisted of three 6-week treatment cycles (18 weeks total), with the primary efficacy assessment occurring at the end of the initial 6-week double-blind, placebo-controlled treatment cycle (Cycle 1). However, this second study extends the double-blind, placebo-controlled assessment to 18 weeks of continuous treatment (no "between-Cycle" treatment breaks) with the primary endpoint assessment occurring at the end of the 18-week timepoint. In the first Phase 3 study, a treatment response of 49% (p<0.0001 vs patients receiving placebo in Cycle 1) was observed in patients completing 18 weeks (3 cycles) of therapy. In this second study, all important clinical study design components remain the same as in the first FLASH study, including the primary endpoint and key inclusion-exclusion criteria. The extended treatment for a continuous 18 weeks in a single cycle is expected to statistically demonstrate HyBryte's™ increased effect over a more prolonged, "real world" treatment course. Given the extensive engagement with the CTCL community, the esteemed Medical Advisory Board and the previous trial experience with this disease, accelerated enrollment in support of this study is anticipated, including the potential to enroll previously identified and treated HyBryte™ patients from the FLASH study. Discussions with the FDA on an appropriate study design remain ongoing. While collaborative, the agency has expressed a preference for a longer duration comparative study over a placebo-controlled trial. Given the shorter time to potential commercial revenue and the similar trial design to the first FLASH study afforded by the EMA accepted protocol, this study was initiated. At the same time, discussions with the FDA will continue on potential modifications to the development path to adequately address their feedback.

Additional supportive studies have demonstrated the utility of longer treatment times (Study RW-HPN-MF-01), the lack of significant systemic exposure to hypericin after topical application (Study HPN-CTCL-02) and its relative efficacy and tolerability compared to Valchlor^® (Study HPN-CTCL-04).

In addition, the FDA awarded an Orphan Products Development grant to support the investigator-initiated study evaluation of HyBryte™ for expanded treatment in patients with early-stage CTCL, including in the home use setting. The grant, totaling $2.6 million over 4 years, was awarded to the University of Pennsylvania that was a leading enroller in the Phase 3 FLASH study.

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the more than 1.7 million individuals living with the disease in the U.S. and Europe (European Union and United Kingdom). It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects approximately 31,000 individuals in the U.S. (based on SEER [Surveillance, Epidemiology, and End Results] data, with approximately 3,200 new cases seen annually) and approximately 38,000 individuals in Europe (based on ECIS [European Cancer Information System] prevalence estimates, with approximately 3,800 new cases annually).

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 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 amount and use of proceeds from the offering and the expected closing date of the offering. 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 study 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 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.

FAQ

What were the 12-week results for HyBryte in the April 2, 2026 Soligenix (SNGX) study?

HyBryte achieved treatment success in 60% of patients at 12 weeks, versus 20% for Valchlor. According to the company, mean cumulative mCAILS improvement was 52.5% for HyBryte versus 34.7% for Valchlor, with no therapy-related adverse events reported for HyBryte.

Did the HyBryte vs Valchlor study (SNGX) show statistically significant results on April 2, 2026?

No, the study did not reach statistical significance due to small sample size. According to the company, the trial was exploratory and the sample size limited statistical power despite clinically notable differences in response rates and mean mCAILS improvements.

How did safety compare between HyBryte and Valchlor in the SNGX 12-week trial?

HyBryte was well tolerated with no therapy-related adverse events, while Valchlor had related AEs in 60% of patients. According to the company, Valchlor-treated patients experienced rashes, dermatitis, and one withdrawal for allergic contact dermatitis.

What is the primary efficacy measure reported for HyBryte in the SNGX study?

The primary measure was ≥50% improvement in cumulative mCAILS score (Treatment Success) at 12 weeks. According to the company, 60% of HyBryte patients met that threshold compared with 20% of Valchlor patients.

Does the April 2, 2026 SNGX publication change HyBryte's clinical safety profile?

The publication reinforces a benign safety profile for HyBryte observed in this small study. According to the company, all HyBryte patients tolerated treatment with no therapy-related adverse events reported during the 12-week course.