HyBryte (synthetic hypericin) / Soligenix - LARVOL DELTA

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

RW-HPN-MF-01: Treatment of Mycosis Fungoides with Hypericin Ointment and Visible Light (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Ellen Kim, MD | N=50 ➔ 20 | Trial completion date: May 2025 ➔ Dec 2026 | Trial primary completion date: May 2025 ➔ Dec 2026

Enrollment change • 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

HyBryte Expanded Treatment Continues to Demonstrate Positive Outcomes in Early-Stage Cutaneous T-Cell Lymphoma (PRNewswire) - P2 | N=50 | RW-HPN-MF-01 (NCT05872854) | "Soligenix, Inc...announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte (synthetic hypericin) treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL)....To date, nine patients have been enrolled and treated with HyBryte over a time period of up to 54 weeks. Patients have responded positively to HyBryte therapy, with over 70% (5 of the 6 subjects who have completed at least 18 weeks of therapy) already achieving 'Treatment Success'....Of the five Treatment Successes, three were achieved within the first 12 weeks of treatment, with two patients achieving a 'complete response' by 18 weeks. Of the remaining patients, two have recently started the study and two had to drop from the study for logistical reasons (e.g., need to care for an elderly parent), with one showing a substantial improvement (>30%) by their Week 18 visit."

P2 data • Cutaneous T-cell Lymphoma

FLASH2: Confirmatory Study of Topical HyBryte™ Vs. Placebo for the Treatment of CTCL (clinicaltrials.gov) - P3 | N=80 | Recruiting | Sponsor: Soligenix | Not yet recruiting ➔ Recruiting

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

Soligenix Initiates Confirmatory Phase 3 Clinical Trial of HyBryte for the Treatment of Cutaneous T-Cell Lymphoma (PRNewswire) - "Soligenix, Inc...announced today that it has opened patient enrollment for its confirmatory Phase 3 study evaluating HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL). The confirmatory Phase 3 study (Fluorescent Light Activated Synthetic Hypericin 2, FLASH2), builds on the previous statistically significant Phase 3 (FLASH) study, as well as a recent successful comparative study (HPN-CTCL-04) and an ongoing investigator-initiated study, each further supporting the design of the FLASH2 clinical trial....'FLASH2 is expected to enroll patients in the United States (U.S.) and Europe, with a formal interim analysis anticipated early in 2026'. FLASH2 is a randomized, double-blind, placebo-controlled, multicenter study that will enroll approximately 80 subjects with early-stage CTCL."

P3 data • Trial status • Cutaneous T-cell Lymphoma

HyBryte Clinical Results Demonstrate Continued Improvement Post-Treatment (PRNewswire) - P2 | N=10 | HPN-CTCL-04 (NCT06149247) | Sponsor: Soligenix | "During the 4-week follow-up period (Week 16) the majority (3 of 5) of HyBryte patients continued to demonstrate lesion improvement with at least a further 10% reduction (absolute difference) at Week 16 relative to the primary outcome measure at Week 12, including one of these patients achieving a 'complete response'. The remaining two HyBryte subjects showed either a modest (15% change), one had a modest decrease, one remained static, and one had a modest improvement by Week 16. Analysis of the individual lesion responses showed similar response profiles, with treatment response observed in 61% of HyBryte™ treated lesions vs. 33% response in Valchlor treated lesions (p=0.18) at Week 12."

P2 data • Cutaneous T-cell Lymphoma

Soligenix Announces Formation of European Medical Advisory Board for Cutaneous T-Cell Lymphoma (PRNewswire) - "Soligenix, Inc...announced today the formation of a 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 with early-stage disease. This confirmatory, 18-week study is expected to enroll approximately 80 patients in the United States (U.S.) and Europe, and is targeted to begin patient enrollment by the end of 2024 with top-line results anticipated in the second half of 2026."

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

Soligenix Receives Hong Kong Patent for Improved Production of Synthetic Hypericin (PRNewswire) - "Soligenix, Inc...announced today that the Hong Kong Patent Office has granted the patent entitled 'Systems and Methods for Producing Synthetic Hypericin'....Synthetic hypericin is the active pharmaceutical ingredient in HyBryte, the Company's photodynamic therapy for the treatment of cutaneous T-cell lymphoma (CTCL), set to initiate a confirmatory Phase 3 clinical trial before the end of the year....HyBryte has shown statistically significant efficacy in a Phase 3 randomized, placebo-controlled trial (FLASH trial, Fluorescent Light Activated Synthetic Hypericin) and will be initiating a second confirmatory Phase 3 placebo-controlled study (FLASH2) in 4Q 2024."

Patent • Trial status • Cutaneous T-cell Lymphoma

HyBryte Expanded Treatment Results to be Presented at the European Organisation for Research and Treatment of Cancer Conference (PRNewswire) - "Soligenix, Inc...announced today that two of its lead investigators are presenting findings from recent additional, supportive trials with HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL)....Dr. Ellen Kim...will present a poster with expanded preliminary results from the investigator-initiated study (RW-HPN-MF-01); Dr. Brian Poligone...will give an oral presentation on recent results from two expanded treatment studies (HPN-CTCL-02 and HPN-CTCL-04) conducted at the Rochester Skin Lymphoma Medical Group."

P2 data • Cutaneous T-cell Lymphoma

Phase 2a Study of Topical 0.25% Hypericin in Mycosis Fungoides: Results and Review of the FLASH Study (EORTC-CLTG 2024) - "Given the solid safety profile of topical synthetic hypericin observed to date, we are investigating whether its therapeutic benefits can be enhanced by increasing the visible light energy delivered to the skin. Ongoing studies will further elucidate the role of this promising topical therapy for patients with mycosis fungoides."

P2a data • Review • Cutaneous T-cell Lymphoma • Mycosis Fungoides • Oncology

Topical hypericin ointment photodynamic therapy for early-stage mycosis fungoides/CTCL – a Phase 2 real world investigator-initiated study. (EORTC-CLTG 2024) - "Aside from mild expected post therapy local skin effects, no drug-related nor serious adverse events have been observed. Conclusions Continuous treatment with higher dose light escalation with SGX301 PDT appears to be well tolerated with an excellent safety profile i and clinical efficacy is consistent with that reported from the previous Phase 3 trial in enrolled patients thus far."

Clinical • P2 data • Real-world • Real-world evidence • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Oncology • T Cell Non-Hodgkin Lymphoma

Soligenix Receives European Patent for Improved Production of Synthetic Hypericin (PRNewswire) - "Soligenix, Inc...announced today that the European Patent Office has granted the patent entitled 'Systems and Methods for Producing Synthetic Hypericin'. The newly issued patent's claims are directed to a novel, highly purified form of synthetic hypericin manufactured through a unique proprietary process....This new European granted patent (EP3423428) is a related patent to US Pat. No. 10,053,413, previously issued in the United States (US). Both patents are expected to expire in 2036, and form part of a larger patent family, including previously granted US patents covering methods of use (US Pat. No. 7,122,518) and methods of synthesis (US Pat. No. 8,629,302), as well as other granted patents throughout the world."

Patent • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Soligenix Announces Recent Accomplishments And Second Quarter 2024 Financial Results (PRNewswire) - "Soligenix's revenues for the quarter ended June 30, 2024 were less than $0.1 million as compared to $0.2 million for the quarter ended June 30, 2023. Revenues primarily relate to government contracts... and evaluation of HyBryte for expanded treatment in patients with early-stage CTCL."

Commercial • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

HyBryte (Synthetic Hypericin) Versus Valchlor (Mechlorethamine) in the Treatment of CTCL (clinicaltrials.gov) - P2 | N=10 | Completed | Sponsor: Soligenix | Recruiting ➔ Completed

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

Expanded HyBryte Treatment Demonstrating Positive Outcomes in Early-Stage Cutaneous T-Cell Lymphoma (PRNewswire) - P3 | N=169 | NCT02448381 | Sponsor: Soligenix | "Soligenix, Inc...announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL)....Patients have responded positively to HyBryte therapy with 75% (3 of the 4 subjects who have completed at least 12 weeks of therapy) already achieving 'Treatment Success', as predefined in the study's protocol as ≥50% improvement in their cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to Baseline. Of the three Treatment Successes, two were achieved within the first 12 weeks of treatment and the third within 18 weeks."

P3 data • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology