Soligenix Announces Recent Accomplishments and Year End 2024 Financial Results
Soligenix (SNGX) reported its financial results for the year ended December 31, 2024, with a net loss of $8.3 million ($4.98 per share) compared to $6.1 million in 2023. Revenue decreased to $0.1 million from $0.8 million in the previous year.
The company maintains $7.8 million in cash, providing operational runway through 2025. Research and development expenses increased to $5.2 million from $3.3 million, while general and administrative expenses decreased to $4.2 million from $4.5 million.
Key developments include patient enrollment for the confirmatory Phase 3 study of HyBryte™ in CTCL treatment, with top-line results expected in 2026. Additionally, top-line results from Phase 2 studies for SGX945 in Behçet's disease and SGX302 in psoriasis are anticipated in the second half of 2025.
Soligenix (SNGX) ha riportato i risultati finanziari per l'anno conclusosi il 31 dicembre 2024, con una perdita netta di 8,3 milioni di dollari (4,98 dollari per azione) rispetto a 6,1 milioni di dollari nel 2023. I ricavi sono diminuiti a 0,1 milioni di dollari da 0,8 milioni di dollari nell'anno precedente.
L'azienda mantiene 7,8 milioni di dollari in contante, garantendo così un supporto operativo fino al 2025. Le spese per ricerca e sviluppo sono aumentate a 5,2 milioni di dollari da 3,3 milioni, mentre le spese generali e amministrative sono diminuite a 4,2 milioni di dollari da 4,5 milioni.
I principali sviluppi includono l'arruolamento di pazienti per lo studio di conferma di Fase 3 di HyBryte™ nel trattamento del CTCL, con risultati preliminari attesi nel 2026. Inoltre, i risultati preliminari degli studi di Fase 2 per SGX945 nella malattia di Behçet e SGX302 nella psoriasi sono previsti nella seconda metà del 2025.
Soligenix (SNGX) informó sus resultados financieros para el año que terminó el 31 de diciembre de 2024, con una pérdida neta de 8.3 millones de dólares (4.98 dólares por acción) en comparación con 6.1 millones de dólares en 2023. Los ingresos disminuyeron a 0.1 millones de dólares desde 0.8 millones de dólares en el año anterior.
La compañía mantiene 7.8 millones de dólares en efectivo, lo que proporciona un margen operativo hasta 2025. Los gastos de investigación y desarrollo aumentaron a 5.2 millones de dólares desde 3.3 millones, mientras que los gastos generales y administrativos disminuyeron a 4.2 millones de dólares desde 4.5 millones.
Los desarrollos clave incluyen la inscripción de pacientes para el estudio de confirmación de Fase 3 de HyBryte™ en el tratamiento del CTCL, con resultados preliminares esperados en 2026. Además, se anticipan resultados preliminares de los estudios de Fase 2 para SGX945 en la enfermedad de Behçet y SGX302 en la psoriasis para la segunda mitad de 2025.
Soligenix (SNGX)는 2024년 12월 31일로 종료된 회계연도에 대한 재무 결과를 보고했으며, 830만 달러의 순손실(주당 4.98달러)을 기록하여 2023년의 610만 달러에서 증가했습니다. 매출은 전년의 80만 달러에서 10만 달러로 감소했습니다.
회사는 780만 달러의 현금을 보유하고 있어 2025년까지 운영 자금을 확보하고 있습니다. 연구 및 개발 비용은 330만 달러에서 520만 달러로 증가했으며, 일반 및 관리 비용은 450만 달러에서 420만 달러로 감소했습니다.
주요 개발 사항으로는 CTCL 치료를 위한 HyBryte™의 확인 단계 3 연구에 대한 환자 등록이 포함되며, 2026년에 주요 결과가 예상됩니다. 또한 Behçet 병에 대한 SGX945의 2상 연구와 건선에 대한 SGX302의 2상 연구의 주요 결과는 2025년 하반기에 발표될 예정입니다.
Soligenix (SNGX) a annoncé ses résultats financiers pour l'année clôturée le 31 décembre 2024, avec une perte nette de 8,3 millions de dollars (4,98 dollars par action) par rapport à 6,1 millions de dollars en 2023. Les revenus ont diminué à 0,1 million de dollars contre 0,8 million de dollars l'année précédente.
L'entreprise dispose de 7,8 millions de dollars en liquidités, offrant une marge opérationnelle jusqu'en 2025. Les dépenses de recherche et développement ont augmenté à 5,2 millions de dollars contre 3,3 millions de dollars, tandis que les dépenses générales et administratives ont diminué à 4,2 millions de dollars contre 4,5 millions de dollars.
Les développements clés incluent l'inscription de patients pour l'étude de confirmation de Phase 3 de HyBryte™ dans le traitement du CTCL, avec des résultats préliminaires attendus en 2026. De plus, les résultats préliminaires des études de Phase 2 pour SGX945 dans la maladie de Behçet et SGX302 dans le psoriasis sont anticipés pour la seconde moitié de 2025.
Soligenix (SNGX) hat seine finanziellen Ergebnisse für das Jahr zum 31. Dezember 2024 veröffentlicht, mit einem Nettoverlust von 8,3 Millionen Dollar (4,98 Dollar pro Aktie) im Vergleich zu 6,1 Millionen Dollar im Jahr 2023. Der Umsatz sank auf 0,1 Millionen Dollar von 0,8 Millionen Dollar im Vorjahr.
Das Unternehmen hält 7,8 Millionen Dollar in bar, was einen operativen Spielraum bis 2025 bietet. Die Forschungs- und Entwicklungskosten stiegen auf 5,2 Millionen Dollar von 3,3 Millionen Dollar, während die allgemeinen und administrativen Kosten auf 4,2 Millionen Dollar von 4,5 Millionen Dollar sanken.
Zu den wichtigsten Entwicklungen gehört die Patientenanmeldung für die bestätigende Phase-3-Studie von HyBryte™ zur Behandlung von CTCL, wobei die Ergebnisse voraussichtlich 2026 erwartet werden. Darüber hinaus werden die Ergebnisse der Phase-2-Studien für SGX945 bei der Behçet-Krankheit und SGX302 bei Psoriasis in der zweiten Hälfte des Jahres 2025 erwartet.
- Positive interim results from HyBryte™ extended treatment study
- Successfully initiated patient enrollment in confirmatory Phase 3 CTCL study
- Expanded clinical pipeline with Phase 2 studies in Behçet's Disease and psoriasis
- Reduced G&A expenses by $0.3M year-over-year
- Revenue declined 87.5% to $0.1M from $0.8M YoY
- Net loss increased 36% to $8.3M from $6.1M YoY
- R&D expenses increased 57.6% to $5.2M from $3.3M YoY
- cash runway through 2025 may require additional financing
Insights
Soligenix's financial results reveal concerning trends that warrant investor attention. Revenue dropped significantly to
The company's R&D expenses increased
For a company with
Soligenix's clinical pipeline shows meaningful advancement across multiple rare disease programs, with particular progress in their HyBryte™ platform. The confirmatory Phase 3 trial for HyBryte™ in early-stage cutaneous T-cell lymphoma (CTCL) is now actively enrolling with projected topline results in 2026. Encouraging data from their open-label study demonstrated continued improvement in HyBryte™-treated patients even after treatment cessation, suggesting potential durability advantages over existing therapies.
The company has simultaneously advanced two Phase 2 programs expected to yield results in H2 2025: SGX945 (dusquetide) for Behçet's disease and SGX302 (synthetic hypericin) for mild-to-moderate psoriasis. The formation of a European Medical Advisory Board enhances their clinical strategy and potential market access planning.
However, the timeline to potential commercialization remains lengthy, with their most advanced program (HyBryte™) not expected to produce Phase 3 results until 2026, followed by regulatory submission timeline that would likely push potential approval into 2027-2028. This extended development runway requires substantial additional capital beyond their stated cash runway through 2025, creating significant uncertainty around their ability to fully realize the value of their pipeline without substantial dilution or unfavorable partnership terms.
"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)," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. In the second half of this year, we also anticipate reporting top-line results from our ongoing Phase 2 studies for SGX945 (dusquetide) in Behçet's disease and SGX302 (synthetic hypericin) in mild-to-moderate psoriasis."
Dr. Schaber continued, "With approximately
Soligenix Recent Accomplishments
- On January 14, 2025, the Company reported positive outcomes observed from the interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ treatment for up to 12 months in patients with early-stage CTCL. To view this press release, please click here.
- On December 16, 2024, the Company announced that it had opened patient enrollment for its confirmatory Phase 3 study evaluating HyBryte™ in the treatment of CTCL. To view this press release, please click here.
- On December 2, 2024, the Company announced analysis of the post-treatment data from the open-label study (protocol HPN-CTCL-04) comparing HyBryte™ to Valchlor® (mechlorethamine) demonstrating continued improvement in HyBryte™ treated patients and their individual lesions even after stopping treatment. To view this press release, please click here.
- On November 19, 2024, the Company announced 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™ in the treatment of CTCL patients with early-stage disease. To view this press release, please click here.
- On November 14, 2024, the Company announced it had opened patient enrollment for its Phase 2 study (protocol number DUS-AUBD-01) evaluating SGX945 (dusquetide) in the treatment of Behçet's Disease. To view this press release, please click here.
Financial Results – Quarter Ended December 31, 2024
Soligenix reported revenues of
Soligenix's net loss was
Research and development expenses were
General and administrative expenses were
As of December 31, 2024, the Company's cash position was approximately
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, the expected timing for closing the offering described herein and the intended use of proceeds therefrom. 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
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SOURCE SOLIGENIX, INC.