HyBryte (synthetic hypericin) / Soligenix - LARVOL DELTA

HyBryte - A Promising Photodynamic Therapy for Cutaneous T-Cell Lymphoma (ESDR 2026) - No abstract available

Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • T Cell Non-Hodgkin Lymphoma

Soligenix Announces…Second Quarter 2026 Financial Results (Soligenix Press Release) - "'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'...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."

Commercial • Discontinued • Cutaneous T-cell Lymphoma

FLASH2: Confirmatory Study of Topical HyBryte vs. Placebo for the Treatment of CTCL (clinicaltrials.gov) - P3 | N=70 | Terminated | Sponsor: Soligenix | Trial completion date: Oct 2026 ➔ May 2026 | Recruiting ➔ Terminated; The Data Monitoring Committee conducted an interim analysis and recommended that the study be halted for futility

Trial completion date • Trial termination • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

“A Confirmatory Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Topical HyBryte™ (Hypericin Sodium) and Visible-Light Activation for the Treatment of Cutaneous T-Cell Lymphoma (CTCL)”: Interim Analysis Results of Primary Efficacy and Safety for FLASH2 (BAD 2026) - "It concluded that there are no safety concerns with the ongoing phase III study and that HyBryte has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies. Abstracts i219"

Clinical • P3 data • P3 data: top line • Cutaneous T-cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Pruritus • T Cell Non-Hodgkin Lymphoma

Soligenix Announces Interim Results from the Phase 3 FLASH2 Trial Evaluating HyBryte in Treatment of Cutaneous T-Cell Lymphoma (PRNewswire) - "Under the terms of the interim analysis, the study was recommended to halt for futility....'Despite the fact that HyBryte demonstrated statistically significant reductions in CTCL lesions after 6 weeks treatment in the first FLASH study, a similar signal was not observed with 18 weeks of treatment in this study. Over the coming weeks, we will analyze the data to better determine why the study did not meet expectations'."

P3 data • Trial termination • Cutaneous T-cell Lymphoma

Positive Clinical Results from HyBryte Comparative Study Evaluating HyBryte Against Valchlor in the Treatment of Cutaneous T-Cell Lymphoma Published in Oncology and Therapy (PRNewswire) - "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."

P2 data • Cutaneous T-cell Lymphoma

Emerging Therapeutic Strategies in Cutaneous T-Cell Lymphoma: A Comprehensive Review of Clinical Trials. (PubMed, Am J Clin Dermatol) - "The 2020-2025 period brought meaningful therapeutic advances for CTCL, including new FDA approvals, breakthrough designations, and emergence of cellular therapy. Future development should prioritize patient-reported outcomes as co-primary endpoints, prospective biomarker validation, and combination strategies with non-overlapping toxicity profiles."

IO biomarker • Journal • Review • Cutaneous T-cell Lymphoma • Dermatology • Hematological Disorders • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • Skin Cancer • T Cell Non-Hodgkin Lymphoma • CD70

Results from a Pilot Study of HyBryte™ (Topical Synthetic Hypericin) Versus Valchlor® (Mechlorethamine) in the Treatment of CTCL. (PubMed, Oncol Ther) - P2 | "This is a single-center, open-label study. It is a pilot study requiring additional research to confirm its results. This study demonstrated the favorable safety and efficacy profile of HyBryte™ compared to Valchlor® in patients with CTCL. HyBryte™ showed higher treatment success rates and was better tolerated."

Journal • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • T Cell Non-Hodgkin Lymphoma

Soligenix Announces Recent Accomplishments and Year End 2025 Financial Results (PRNewswire) - "Upcoming high-impact milestones include...top-line results in H2 2026 from HyBryte trial."

P3 data: top line • Cutaneous T-cell Lymphoma

Soligenix Advances Orphan Drug Strategy with HyBryte for Rare Skin Cancer Treatment (City Buzz) - "The company is nearing completion of a confirmatory Phase 3 study for HyBryte, with interim analysis expected in early 2026 and top-line results later in the year, alongside supportive data showing strong patient response rates."

P3 data: top line • Trial status • Cutaneous T-cell Lymphoma

Soligenix, Inc…announced today that findings from recent supportive trials with HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) are being presented at the United States Cutaneous Lymphoma Consortium (USCLC) Workshop (March 26, 2026), which precedes the American Academy of Dermatology (AAD) Annual Meeting. (PRNewswire) - "Dr. Kim will detail positive results from the recently completed investigator-initiated study using HyBryte as a long-term treatment of CTCL. A poster also will be presented at the conference sharing the positive results of a study evaluating HyBryte versus Valchlor (mechlorethamine) conducted by Brian Poligone, MD, PhD, Director of the Rochester Skin Lymphoma Medical Group and Principal Investigator for the comparability study."

Clinical data • Cutaneous T-cell Lymphoma • Mycosis Fungoides

Soligenix, Inc…announced today that a summary of all the clinical trials completed to date evaluating HyBryte (synthetic hypericin) as a treatment for cutaneous T-cell lymphoma (CTCL) has been published in the peer-reviewed medical journal Expert Opinion on Investigational Drugs. (Soligenix Press Release) - "HyBryte has been demonstrated to have a non-mutagenic mechanism of action, uses a non-carcinogenic light source and appears to have improved tolerability relative to available therapies such as mechlorethamine. The rapid response rates and the efficacy demonstrated on thicker plaque lesions, combined with its activity in difficult to treat disease variants like folliculotropic mycosis fungoides, makes HyBryte a potential broad-spectrum, first-line option for patients with early-stage CTCL."

Clinical • Cutaneous T-cell Lymphoma

Topical hypericin: a promising photodynamic therapy for early-stage cutaneous T-cell lymphoma. (PubMed, Expert Opin Investig Drugs) - "Topical photodynamic therapy with synthetic hypericin (research name: SGX301; trade name: HyBryte™) has emerged as a novel agent addressing this gap...Minimal local adverse events and limited systemic absorption offer a key long-term safety advantage over conventional phototherapies. Its effectiveness in both patch and plaque lesions makes it a versatile tool, improving outcomes and quality of life for patients."

Journal • Review • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • T Cell Non-Hodgkin Lymphoma

RW-HPN-MF-01: Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light (clinicaltrials.gov) - P2 | N=10 | Completed | Sponsor: Ellen Kim, MD | Active, not recruiting ➔ Completed | N=20 ➔ 10

Enrollment change • Trial completion • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Soligenix…announced today that it has 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 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) (PRNewswire) - "With 50 patients enrolled, the planned interim analysis will occur in the second quarter of 2026....We look forward to completing this study on schedule with topline results in the second half of 2026'."

Enrollment status • P3 data: top line • Cutaneous T-cell Lymphoma

Soligenix Announces Recent Accomplishments… (PRNewswire) - "...'We remain focused on multiple upcoming milestones before year-end, including...an enrollment update for the confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma'..."

Enrollment status • Cutaneous T-cell Lymphoma

Soligenix Achieves Important Safety Milestone in its Confirmatory Phase 3 Clinical Trial of HyBryte for the Treatment of Cutaneous T-Cell Lymphoma (PRNewswire) - "Soligenix...announced today that its first Data Monitoring Committee (DMC) meeting for its confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) has concluded that there are no safety concerns with the ongoing Phase 3 study and that HyBryte has an acceptable safety profile....With enrollment proceeding well, Soligenix anticipates providing an enrollment update in 4Q2025 and supporting the DMC in undertaking a pre-specified blinded interim efficacy analysis in 1H2026."

DSMB • Enrollment status • P3 data • Cutaneous T-cell Lymphoma

Soligenix…announced today the expansion of its European Medical Advisory Board (MAB) to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients… (PRNewswire) - "This confirmatory, 18-week study is expected to enroll approximately 80 patients and is targeted to report top-line results in the second half of 2026."

Clinical • P3 data: top line • Cutaneous T-cell Lymphoma

RW-HPN-MF-01: Treatment of Mycosis Fungoides With Hypericin Ointment and Visible Light (clinicaltrials.gov) - P2 | N=20 | Active, not recruiting | Sponsor: Ellen Kim, MD | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2026 ➔ Dec 2025 | Trial primary completion date: Dec 2026 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma

Soligenix Announces Recent Accomplishments... (PRNewswire) - "'...continued clinical update for the ongoing investigator-initiated study (IIS) evaluating extended HyBryte (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage cutaneous T-cell lymphoma (CTCL). Further, we anticipate top-line results in 2026 from our actively enrolling confirmatory Phase 3 study of HyBryte (synthetic hypericin) for early-stage CTCL, where we plan to provide an enrollment update later this year.'"

Enrollment status • P3 data: top line • Cutaneous T-cell Lymphoma

Soligenix Inc. (SNGX) Showcases Promising HyBryte Results in CTCL Treatment Through New Podcast (City Buzz) - P3 | N=80 | FLASH2 (NCT06470451) | Sponsor: Soligenix | "Soligenix Inc. (SNGX) has recently highlighted the progress of HyBryte (synthetic hypericin) in treating early-stage cutaneous T-cell lymphoma (CTCL) through a podcast hosted by the Cutaneous Lymphoma Foundation. Dr. Ellen Kim, the Principal Investigator of the ongoing study and Director of the Penn Cutaneous Lymphoma Program, shared encouraging interim data, including a 75% treatment success rate at 18 weeks and up to 85% improvement in patients treated through 54 weeks."

P3 data • Cutaneous T-cell Lymphoma

Soligenix Announces Recent Accomplishments And First Quarter 2025 Financial Results (PRNewswire) - "Our strategic focus remains on advancing our clinical programs, and we anticipate several significant development milestones. These include top-line results in 2026 from our actively enrolling Phase 3 confirmatory study of HyBryte™ (synthetic hypericin) for early-stage cutaneous T-cell lymphoma (CTCL)."

P3 data: top line • Cutaneous T-cell Lymphoma

Positive Outcome in 75% of CTCL Patients Treated with HyBryte for 18 Weeks (PRNewswire) - P2 | N=50 | RW-HPN-MF-01 (NCT05872854) | "Soligenix, Inc...announced today interim results from the ongoing open-label, investigator-initiated study (IIS) evaluating extended HyBryte (synthetic hypericin) treatment for up to 54 weeks in patients with early-stage cutaneous T-cell lymphoma (CTCL). Following 18 weeks of treatment, 75% of patients achieved 'Treatment Success,' reinforcing HyBryte as a potentially safe and fast-acting therapy for this chronic and underserved cancer....Of these eight evaluable patients through Week 18, four have gone on to complete the 54-week treatment with an average maximum improvement in mCAILS score of 85%, three are still on treatment and one dropped out (due to logistical issues). HyBryte appears to be safe and well tolerated in all patients."

P2 data • Cutaneous T-cell Lymphoma

Soligenix Announces Recent Accomplishments and Year End 2024 Financial Results (PRNewswire) - "'We remain highly focused on advancing our multiple clinical programs as we work towards achieving a number of important and potentially transformational development milestones, including top-line results in 2026 for our actively enrolling confirmatory Phase 3 placebo-controlled study evaluating HyBryte (synthetic hypericin) in the treatment of early-stage cutaneous T-cell lymphoma (CTCL)'..."

P3 data • Cutaneous T-cell Lymphoma

HyBryte Treatment Studies Presented at Two Medical Conferences in March (PRNewswire) - "Soligenix, Inc...announced today that its lead investigators for the cutaneous T-cell lymphoma (CTCL)...presenting findings from recent supportive trials with HyBryte (synthetic hypericin) in the treatment of CTCL...The presentations will occur at the United States Cutaneous Lymphoma Consortium (USCLC) Workshop (March 6, 2025)...Ellen Kim....will present a poster at the USCLC detailing recent results from an ongoing investigator-initiated study using HyBryte as a long-term treatment of CTCL."

P2 data • Real-world • Cutaneous T-cell Lymphoma • Mycosis Fungoides