Tillkännagivande • May 18

Soligenix, Inc. Announces Positive Clinical Results from HyBryte Compatibility Study in the Treatment of Cutaneous T-Cell Lymphoma

Soligenix, Inc. announced that the results of its compatibility study evaluating HyBryte™ (synthetic hypericin) for the treatment of cutaneous T-cell lymphoma (CTCL) have been published in the Journal of the European Academy of Dermatology & Venereology (JEADV) Clinical Practice. The publication highlights the positive clinical results from study, HPN-CTCL-02, evaluating HyBryte™ in the treatment of CTCL. The open-label study enrolled 9 patients to receive 8 weeks of HyBryte™ treatment of their cancerous lesions, with an assessment of treatment response conducted at week 10 using the modified Composite Assessment of Index Lesion Severity (mCAILS) score. The treatment response results of 22% following 8 weeks of twice weekly HyBryte™ therapy reinforces and confirms the results of the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial published in the Journal of the American Medical Association (JAMA) Dermatology, despite the fact that patients in Study HPN-CTCL-02 were specifically selected to have more extensive disease consistent with its potential commercial use. Additionally, in this study all patients had improvements in their cumulative mCAILS score (average improvement of 36.4%, range 8 to 100%). Results in individual lesions showed that 7 of the 27 index lesions (25.9%) had at least a 50% improvement in their mCAILS score and 4 of the 27 index lesions (14.8%) were completely resolved after as little as 8 weeks of treatment. Other key evaluations included measurements of systemic exposure and electrocardiograms, which yielded extremely low and limited levels of systemic hypericin (plateau concentration of approximately 0.00013 µg/mL) detected in the blood and no observable impact to normal sinus rhythm, reinforcing the safety of 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 U.S. Food and Drug Administration (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 CAILS 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 groups also revealed a statistically significant improvement (p<0.0001) between the two groups, 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 in particular. 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. 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. 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, is expected to be initiated before the end of 2024.

Biotechs Tillväxt i branschen	-14.59%
Intäkternas tillväxttakt	-37.90%
Avkastning på eget kapital	n/a
Nettomarginal	-1,454.12%
Senaste uppdateringen av resultatet	31 Dec 2022

Datum	Intäkter	Intäkter	G+A Kostnader	FoU-kostnader
31 Dec 22	1	-14	7	8
30 Sep 22	1	-15	7	8
30 Jun 22	1	-15	7	9
31 Mar 22	1	-15	6	9
31 Dec 21	1	-13	5	8
30 Sep 21	1	-13	5	9
30 Jun 21	1	-12	5	8
31 Mar 21	2	-12	4	8
31 Dec 20	2	-18	4	15
30 Sep 20	3	-15	3	13
30 Jun 20	3	-16	3	14
31 Mar 20	4	-15	3	14
31 Dec 19	5	-9	3	8
30 Sep 19	5	-10	3	8
30 Jun 19	5	-9	3	7
31 Mar 19	5	-8	3	7
31 Dec 18	5	-9	3	7
30 Sep 18	6	-8	3	6
30 Jun 18	6	-7	3	5
31 Mar 18	5	-8	3	6
31 Dec 17	5	-7	3	6
30 Sep 17	6	-5	3	4
30 Jun 17	7	-6	3	5
31 Mar 17	9	-4	3	4
31 Dec 16	10	-3	3	4
30 Sep 16	12	-5	4	5
30 Jun 16	13	-1	4	5

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2023/05/09 17:23
Aktiekurs vid dagens slut	2023/02/09 00:00
Intäkter	2022/12/31
Årlig intjäning	2022/12/31

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
James Molloy	Alliance Global Partners
Andrew D'Silva	B. Riley Securities, Inc.
Keith Markey	Griffin Securities

This company listing is no longer active

Soligenix Tidigare resultatutveckling

Tidigare kriterier kontrolleras 0/6

Viktig information

Senaste uppdateringar av tidigare prestationer

Third quarter 2022 earnings released: US$0.077 loss per share (vs US$0.088 loss in 3Q 2021)

Third quarter 2022 earnings released: US$0.077 loss per share (vs US$0.088 loss in 3Q 2021)

Second quarter 2022 earnings released: US$0.055 loss per share (vs US$0.047 loss in 2Q 2021)

First quarter 2022 earnings released: US$0.10 loss per share (vs US$0.064 loss in 1Q 2021)

Full year 2021 earnings released: US$0.31 loss per share (vs US$0.64 loss in FY 2020)

Third quarter 2021 earnings released: US$0.088 loss per share (vs US$0.061 loss in 3Q 2020)

Recent updates

Soligenix Achieves Important Safety Milestone in Its Confirmatory Phase 3 Clinical Trial of Hybryte for the Treatment of Cutaneous T-Cell Lymphoma

Soligenix Announces Expansion of European Medical Advisory Board for Cutaneous T-Cell Lymphoma

Soligenix, Inc. has completed a Follow-on Equity Offering in the amount of $7.500006 million.

Soligenix, Inc. has filed a Follow-on Equity Offering in the amount of $7.999998 million.

Soligenix, Inc. Announces Publication Recommending Long-Term High Temperature Stability of Protein Subunit Vaccines forbola and Related Viruses

Soligenix Receives Notice from Nasdaq Due to Non-Compliance with the Minimum Stockholders’ Equity Requirement for its Common Stock

Soligenix Inc. Announces Audio Press Release on Promising First-Line Therapy for Rare Skin Cancer

Soligenix, Inc. Completes its Phase 2a Proof of Concept Study Evaluating SGX945 (Dusquetide) in Treatment of Behcet's Disease and Achieves Study Objective of Demonstrating Biological Efficacy

Soligenix, Inc. Announces Synthetic Hypericin Successfully Manufactured At Sterling Pharma Solutions

Soligenix, Inc. Highlights Dr. Ellen Kim's Recent Q&A and the Promise of HyBryte in Ongoing Clinical Trials

Soligenix, Inc., Annual General Meeting, Jun 20, 2025

Soligenix, Inc. Announces Interim Results from the Ongoing Open-Label, Investigator-Initiated Study Evaluating Extended HyBryte

Soligenix, Inc. Announces an Interim Update on the Open-Label, Investigator-Initiated Study Evaluating Extended HyBryte

Soligenix, Inc. Initiates Confirmatory Phase 3 Clinical Trial of HyBryte for the Treatment of Cutaneous T-Cell Lymphoma

Soligenix, Inc. Announces Formation of European Medical Advisory Board for Cutaneous T-Cell Lymphoma

Soligenix Initiates A Phase 2 Clinical Trial of SGX945 (Dusquetide) for the Treatment of Behcet's Disease

Soligenix, Inc. Announces HyBryte Expanded Treatment Results to Be Presented at the European Organisation for Research and Treatment of Cancer Conference

Soligenix, Inc. Announces Significant Progress in the Treatment of Cutaneous T-Cell Lymphoma with its Investigational Drug, HyBryte™

Soligenix, Inc. Announces an Interim Update on the Open-Label, Investigator-Initiated Study Evaluating Extended HyBryte Treatment for Up to 12 Months in Patients with Early-Stage Cutaneous T-Cell Lymphoma

Soligenix, Inc. Announces Positive Clinical Results from A Comparative Study Evaluating Hybryte™? Against Valchlor®? in the Treatment of Cutaneous T-Cell Lymphoma

Soligenix, Inc. Announces Positive Clinical Results from HyBryte Compatibility Study in the Treatment of Cutaneous T-Cell Lymphoma

Soligenix, Inc., Annual General Meeting, May 23, 2024

Soligenix Extends Patent Protection for Its Filovirus Vaccine Platform to the United Kingdom and South Africa

Soligenix Announces Agreement on the Design of Second Confirmatory Placebo-Controlled Trial for Hybryte™ with the European Medicines Agency

Soligenix, Inc. Announces Formation of Behçet's Disease Medical Advisory Board

FDA Grants Soligenix "Fast Track" Designation for Dusquetide in the Treatment of Oral Lesions of Behçet's Disease

Soligenix Announces Top-Line Results of the Phase 2A Study of Sgx302 (Synthetic Hypericin) in Patients with Mild-To-Moderate Psoriasis

Soligenix Announces Publication Demonstrating Complete Protection Against Filovirus Disease in Nonhuman Primate Models of Ebola and Marburg Viruses

Soligenix Receives Written Notice from Nasdaq Regarding Non-Compliance with the Minimum Bid Price Rule and Not Eligible for Second 180 Day Period

Soligenix, Inc. Receives FDA IND Clearance for Phase 2 Clinical Trial of Dusquetide in Treatment of Aphthous Ulcers in Behçet's Disease

Soligenix, Inc. Announces HyBryte(TM) Expanded Treatment Trial in Cutaneous T-Cell Lymphoma Opens Enrollment

Soligenix, Inc., Annual General Meeting, Sep 21, 2023

Soligenix Announces Expansion of SGX302 (Synthetic Hypericin) Phase 2a Study in Mild-to-Moderate Psoriasis

Timothy R. Coté Resigned as A Member of the Board of Directors of Soligenix, Inc

Soligenix Regains Compliance with the Shareholders’ Equity Requirement and in Compliance with All Other Applicable Requirements for Listing on Nasdaq

Soligenix, Inc. Announces Scheduling of Type A Meeting with the U.S. FDA to Review Proposed Study Design for a Second Phase 3 Study Evaluating HyBryte(TM) in the Treatment of Cutaneous T-Cell Lymphoma

Soligenix Announces Positive Clinical Results from Compatibility Study of HyBryte in the Treatment of Cutaneous T-Cell Lymphoma

Soligenix, Inc. Announces Appointment of Timothy R. Coté, M.D. to Its Board of Directors

Soligenix, Inc. Receives Refusal to File Letter from U.S. FDA for Hybryte™ New Drug Application in the Treatment of Cutaneous T-Cell Lymphoma

Soligenix Announces Publication Demonstrating Positive Correlates of Protection with Rivax® in Non-Human Primate Survival After Ricin Challenge

Soligenix, Inc. Initiates Phase 2 Clinical Trial of SGX302 (Synthetic Hypericin) for the Treatment of Mild-To-Moderate Psoriasis

Soligenix Announces Submission of New Drug Application to the FDA for Hybryte™ in the Treatment of Cutaneous T-Cell Lymphoma

Soligenix Receives Non Compliance Notice from Nasdaq

Third quarter 2022 earnings released: US$0.077 loss per share (vs US$0.088 loss in 3Q 2021)

Insufficient new directors

Third quarter 2022 earnings released: US$0.077 loss per share (vs US$0.088 loss in 3Q 2021)

Soligenix, Inc. Announces U.S. Food and Drug Administration Awards $2.6 Million Orphan Products Development Grant for Expanded Study of HyBryte in the Treatment of Cutaneous T-Cell Lymphoma

Second quarter 2022 earnings released: US$0.055 loss per share (vs US$0.047 loss in 2Q 2021)

Soligenix, Inc., Annual General Meeting, Sep 22, 2022

Soligenix, Inc. Receives Agreement from FDA on Initial Pediatric Study Plan for HyBryte for the Treatment of Cutaneous T-Cell Lymphoma

Soligenix, Inc. Announces HyBryte™ Phase 3 FLASH Study for the Treatment of Cutaneous T-Cell Lymphoma Published in JAMA Dermatology

Soligenix, Inc. Receives FDA IND Clearance for Phase 2 Clinical Trial of Synthetic Hypericin in Treatment of Psoriasis

Soligenix Announces Successful Protection Using A Bivalent Thermostabilized Filovirus Vaccine

Soligenix Receives US Patent Allowance for Its Thermostabilized Vaccine Platform

First quarter 2022 earnings released: US$0.10 loss per share (vs US$0.064 loss in 1Q 2021)

Insufficient new directors

No longer forecast to breakeven

Full year 2021 earnings released: US$0.31 loss per share (vs US$0.64 loss in FY 2020)

Soligenix, Inc. Demonstrates Positive Anti-Tumor Efficacy in Multiple Nonclinical Animal Studies

Forecast to breakeven in 2024

Third quarter 2021 earnings released: US$0.088 loss per share (vs US$0.061 loss in 3Q 2020)

Insufficient new directors

Fördelning av intäkter och kostnader

Resultat- och intäktshistorik

Fritt kassaflöde vs resultatanalys

Analys av tidigare vinsttillväxt

Avkastning på eget kapital

Avkastning på tillgångar