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Soligenix Announces Recent Accomplishments And Third Quarter 2024 Financial Results

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Soligenix (NASDAQ: SNGX) reported its Q3 2024 financial results and recent accomplishments. The company ended the quarter with $9.8 million in cash and reported a net loss of $1.7 million ($0.78 per share). Key developments include preparations for a confirmatory Phase 3 study of HyBryte™ for CTCL treatment and an upcoming Phase 2 study for SGX945 in Behçet's disease. The company secured patents in Hong Kong and Europe for synthetic hypericin production and established a partnership with Sterling Pharma Solutions. Research and development expenses increased to $1.0 million from $0.8 million year-over-year, while general and administrative expenses decreased to $0.9 million from $1.0 million.

Soligenix (NASDAQ: SNGX) ha riportato i risultati finanziari del terzo trimestre 2024 e recenti successi. L'azienda ha concluso il trimestre con 9,8 milioni di dollari in cassa e ha registrato una perdita netta di 1,7 milioni di dollari (0,78 dollari per azione). Tra i principali sviluppi ci sono i preparativi per uno studio di conferma di Fase 3 di HyBryte™ per il trattamento del CTCL e uno studio di Fase 2 in arrivo per SGX945 nella malattia di Behçet. L'azienda ha ottenuto brevetti a Hong Kong e in Europa per la produzione di iperico sintetico e ha stabilito una partnership con Sterling Pharma Solutions. Le spese per ricerca e sviluppo sono aumentate a 1,0 milioni di dollari rispetto agli 0,8 milioni di dollari dell'anno precedente, mentre le spese generali e amministrative sono diminuite a 0,9 milioni di dollari rispetto a 1,0 milioni di dollari.

Soligenix (NASDAQ: SNGX) informó sus resultados financieros del tercer trimestre de 2024 y logros recientes. La compañía terminó el trimestre con 9,8 millones de dólares en efectivo y reportó una pérdida neta de 1,7 millones de dólares (0,78 dólares por acción). Los desarrollos clave incluyen los preparativos para un estudio de confirmación de Fase 3 de HyBryte™ para el tratamiento de CTCL y un próximo estudio de Fase 2 para SGX945 en la enfermedad de Behçet. La compañía obtuvo patentes en Hong Kong y Europa para la producción de hipericina sintética y estableció una asociación con Sterling Pharma Solutions. Los gastos de investigación y desarrollo aumentaron a 1,0 millones de dólares desde 0,8 millones de dólares interanualmente, mientras que los gastos generales y administrativos disminuyeron a 0,9 millones de dólares desde 1,0 millones de dólares.

솔리제닉스 (NASDAQ: SNGX)는 2024년 3분기 재무 결과 및 최근 성과를 보고했습니다. 회사는 분기를 980만 달러의 현금으로 마감했으며 170만 달러의 순손실을 기록했습니다 (주당 0.78 달러). 주요 발전 사항으로는 CTCL 치료를 위한 HyBryte™의 확인적 3상 연구 준비와 Behçet 병의 SGX945에 대한 다가오는 2상 연구가 포함됩니다. 회사는 홍콩과 유럽에서 합성 하이퍼시신 생산에 대한 특허를 확보했으며, 스털링 제약 솔루션과 파트너십을 체결했습니다. 연구 개발 비용은 전년 대비 80만 달러에서 100만 달러로 증가했으며, 일반 및 관리 비용은 100만 달러에서 90만 달러로 감소했습니다.

Soligenix (NASDAQ: SNGX) a annoncé ses résultats financiers du troisième trimestre 2024 et ses réussites récentes. L'entreprise a terminé le trimestre avec 9,8 millions de dollars en espèces et a enregistré une perte nette de 1,7 million de dollars (0,78 dollar par action). Parmi les développements clés figurent les préparatifs pour une étude de confirmation de phase 3 de HyBryte™ pour le traitement du CTCL et une prochaine étude de phase 2 pour SGX945 dans la maladie de Behçet. L'entreprise a obtenu des brevets à Hong Kong et en Europe pour la production d'hypericine synthétique et a établi un partenariat avec Sterling Pharma Solutions. Les dépenses de recherche et développement ont augmenté pour atteindre 1,0 million de dollars contre 0,8 million de dollars d'une année sur l'autre, tandis que les dépenses générales et administratives ont diminué de 1,0 million de dollars à 0,9 million de dollars.

Soligenix (NASDAQ: SNGX) hat die Finanzzahlen für das dritte Quartal 2024 und aktuelle Erfolge bekannt gegeben. Das Unternehmen schloss das Quartal mit 9,8 Millionen Dollar in bar ab und berichtete von einem netto Verlust von 1,7 Millionen Dollar (0,78 Dollar pro Aktie). Zu den wichtigsten Entwicklungen gehören die Vorbereitungen für eine bestätigende Phase-3-Studie von HyBryte™ zur Behandlung von CTCL sowie eine bevorstehende Phase-2-Studie für SGX945 bei der Behçet-Krankheit. Das Unternehmen sicherte sich Patente in Hongkong und Europa für die Herstellung von synthetischem Hypericin und ging eine Partnerschaft mit Sterling Pharma Solutions ein. Die Forschungs- und Entwicklungskosten stiegen von 0,8 Millionen Dollar auf 1,0 Millionen Dollar im Jahresvergleich, während die allgemeinen und administrativen Kosten von 1,0 Millionen Dollar auf 0,9 Millionen Dollar sanken.

Positive
  • Secured new patents in Hong Kong and Europe for synthetic hypericin production
  • Established strategic partnership with Sterling Pharma Solutions
  • Maintained stable cash position of $9.8 million
  • Reduced general and administrative expenses to $0.9 million from $1.0 million
Negative
  • No revenue generated in Q3 2024 compared to $0.1 million in Q3 2023
  • Net loss of $1.7 million in Q3 2024
  • Increased R&D expenses to $1.0 million from $0.8 million

Insights

The Q3 financial results reveal concerning trends for Soligenix. With $0 in revenue compared to $0.1M last year and a net loss of $1.7M, the company continues to burn cash without generating income. The cash position of $9.8M provides roughly 5-6 quarters of runway at current burn rates, which is concerning given the multiple clinical trials planned.

R&D expenses increased 25% to $1.0M, reflecting investments in upcoming clinical trials. While G&A costs decreased slightly to $0.9M, the overall financial health remains precarious. The company's market cap of just $7.9M trading below cash value suggests significant market skepticism about its clinical programs and commercialization potential.

The pipeline progress shows mixed signals. While advancing HyBryte™ into a confirmatory Phase 3 trial for CTCL and initiating Phase 2 studies for both SGX945 in Behçet's disease and SGX302 in psoriasis demonstrates pipeline momentum, the company faces significant execution risks across multiple programs with resources. The recent patent grants for synthetic hypericin production and Sterling Pharma partnership are positive developments for manufacturing scalability, but commercialization remains distant with significant capital needs ahead.

PRINCETON, N.J., Nov. 8, 2024 /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 its recent accomplishments and financial results for the quarter ended September 30, 2024.

 "We remain focused on multiple clinical activities and upcoming milestones, including the initiation of our confirmatory Phase 3 placebo-controlled study evaluating HyBryte™ (synthetic hypericin) in the treatment of early-stage cutaneous T-cell lymphoma (CTCL) before yearend," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. Additionally, we are set to initiate a Phase 2 study for SGX945 (dusquetide) in Behçet's disease shortly, with top-line results expected in the first half of 2025, which will be accompanied by data readout from our ongoing SGX302 (synthetic hypericin) Phase 2 study in mild-to-moderate psoriasis in the first half as well."

Dr. Schaber continued, "With approximately $9.8 million in cash at September 30, 2024, we continue to prioritize resource allocation to achieve our goals. While we remain focused on our future, we are diligently pursuing strategies to enhance long-term shareholder value, including strategic partnerships and mergers and acquisitions." 

Soligenix Recent Accomplishments

  • On October 22, 2024, the Company announced that the Hong Kong Patent Office had granted the patent entitled "Systems and Methods for Producing Synthetic Hypericin", allowing claims for a novel proprietary process of producing highly purified synthetic hypericin. To view this press release, please click here.
  • On October 7, 2024, the Company announced its lead investigators from the University of Pennsylvania and the Rochester Skin Lymphoma Medical Group would present findings from recent supportive studies with HyBryte™ in the treatment of CTCL at the European Organisation for Research and Treatment of Cancer. To view this press release, please click here.
  • On October 3, 2024, the Company announced it has established a partnership agreement with Sterling Pharma Solutions to optimize and implement a commercially viable, scalable production technology for synthetic hypericin. To view this press release, please click here.
  • On September 3, 2024, the Company announced the European Patent Office had granted the patent entitled "Systems and Methods for Producing Synthetic Hypericin", allowing claims for a novel proprietary process of producing highly purified synthetic hypericin. To view this press release, please click here.

Financial Results – Quarter Ended September 30, 2024

Soligenix received no revenue for the quarter ended September 30, 2024 as compared to $0.1 million for the quarter ended September 30, 2023. Revenues primarily relate to government contracts, grants and subawards awarded in support of SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases; development of CiVax™, our vaccine candidate for the prevention of COVID-19, and evaluation of HyBryte™ for expanded treatment in patients with early-stage CTCL.

Soligenix's net loss was $1.7 million for the quarters ended September 30, 2024 and 2023, or ($0.78) per share and ($2.56) per share, respectively. This increase in net loss was primarily due to decreases in gross profit and tax credits as well as an increase in operating expenses, offset by increases in interest income and the change in the fair value of debt during the three months ended September 30, 2024.

Research and development expenses were $1.0 million as compared to $0.8 million for the quarters ended September 30, 2024 and 2023, respectively. The increase was preliminary due to costs associated with the initiation of our Phase 2 study in Behçet's Disease and the second confirmatory Phase 3 CTCL trial offset by an adjustment of estimated accruals for completed clinical trials.

General and administrative expenses were $0.9 million and $1.0 million for the quarters ended September 30, 2024 and 2023, respectively. The decrease in general and administrative expenses for the three months ended September 30, 2024 was primarily attributable to decreases in legal and professional fees.

As of September 30, 2024, the Company's cash position was approximately $9.8 million.

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 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, 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 in the first HyBryte™ (SGX301) Phase 3 clinical trial 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.

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/soligenix-announces-recent-accomplishments-and-third-quarter-2024-financial-results-302299437.html

SOURCE SOLIGENIX, INC.

FAQ

What was Soligenix (SNGX) net loss per share in Q3 2024?

Soligenix reported a net loss of $0.78 per share in Q3 2024.

How much cash did Soligenix (SNGX) have as of September 30, 2024?

Soligenix had approximately $9.8 million in cash as of September 30, 2024.

What are the upcoming clinical trials for Soligenix (SNGX)?

Soligenix is preparing to initiate a confirmatory Phase 3 study of HyBryte™ for CTCL treatment and a Phase 2 study for SGX945 in Behçet's disease, with results expected in first half of 2025.

What new partnerships did Soligenix (SNGX) announce in Q3 2024?

Soligenix announced a partnership agreement with Sterling Pharma Solutions to optimize and implement commercial production technology for synthetic hypericin.

Soligenix, Inc.

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