SCYNEXIS to Receive $10 Million Milestone Payment from GSK Triggered by Delivery of Completed FURI, CARES and NATURE Clinical Study Reports
SCYNEXIS (NASDAQ: SCYX) announced it will receive a $10 million milestone payment from GSK, triggered by the delivery of final clinical study reports for the completed FURI, CARES, and NATURE trials. This payment is part of their exclusive license agreement for ibrexafungerp. Results from the FURI and CARES studies are positive and consistent with previous interim analyses. SCYNEXIS reiterates its cash runway of over two years and plans to advance SCY-247, its next-generation fungerp, into clinical trials later this year. The company has previously received $115 million from GSK and is eligible for up to $323 million more in potential payments, plus tiered royalties on ibrexafungerp sales.
SCYNEXIS (NASDAQ: SCYX) ha annunciato che riceverà un pagamento di milestone di 10 milioni di dollari da GSK, attivato dalla consegna dei rapporti finali degli studi clinici per i trial completati FURI, CARES e NATURE. Questo pagamento fa parte del loro accordo di licenza esclusiva per ibrexafungerp. I risultati degli studi FURI e CARES sono positivi e coerenti con le precedenti analisi interim. SCYNEXIS ribadisce la sua disponibilità di cassa di oltre due anni e prevede di portare SCY-247, il suo fungerp di nuova generazione, negli studi clinici entro la fine di quest'anno. L'azienda ha già ricevuto 115 milioni di dollari da GSK ed è idonea a ricevere fino a 323 milioni di dollari in pagamenti potenziali, oltre a royalties in base alle vendite di ibrexafungerp.
SCYNEXIS (NASDAQ: SCYX) anunció que recibirá un pago por hitos de 10 millones de dólares de GSK, activado por la entrega de los informes finales de los estudios clínicos de los ensayos completados FURI, CARES y NATURE. Este pago es parte de su acuerdo de licencia exclusiva para ibrexafungerp. Los resultados de los estudios FURI y CARES son positivos y coherentes con los análisis interinos previos. SCYNEXIS reitera que tiene un runway de efectivo de más de dos años y planea avanzar SCY-247, su fungerp de próxima generación, a ensayos clínicos a finales de este año. La compañía ya ha recibido 115 millones de dólares de GSK y es elegible para hasta 323 millones de dólares más en pagos potenciales, además de regalías escalonadas por las ventas de ibrexafungerp.
SCYNEXIS (NASDAQ: SCYX)는 GSK로부터 1천만 달러의 이정표 지불금을 받을 것이라고 발표했으며, 이는 완료된 FURI, CARES 및 NATURE 시험에 대한 최종 임상 연구 보고서의 제출로 촉발되었습니다. 이 지불금은 ibrexafungerp에 대한 독점 라이센스 계약의 일환입니다. FURI 및 CARES 연구 결과는 긍정적이며 이전의 중간 분석과 일치합니다. SCYNEXIS는 2년 이상의 현금 지속 가능성을 다시 한번 강조하며, 올해 말에 차세대 fungerp인 SCY-247을 임상 시험으로 진입시킬 계획입니다. 회사는 이전에 GSK로부터 1억 1천5백만 달러를 받았으며, 최대 3억 2천3백만 달러의 추가 잠재적 지급금 및 ibrexafungerp 판매에 대한 단계별 로열티를 받을 자격이 있습니다.
SCYNEXIS (NASDAQ: SCYX) a annoncé qu'elle recevrait un paiement d'étape de 10 millions de dollars de GSK, déclenché par la livraison des rapports finaux des études cliniques pour les essais FURI, CARES et NATURE complétés. Ce paiement fait partie de leur accord de licence exclusif pour l'ibrexafungerp. Les résultats des études FURI et CARES sont positifs et cohérents avec les analyses intermédiaires précédentes. SCYNEXIS réitère sa trésorerie disponible pendant plus de deux ans et prévoit de faire avancer SCY-247, son fungicide de nouvelle génération, vers des essais cliniques plus tard cette année. L'entreprise a déjà reçu 115 millions de dollars de GSK et est éligible à jusqu'à 323 millions de dollars supplémentaires en paiements potentiels, plus des redevances échelonnées sur les ventes d'ibrexafungerp.
SCYNEXIS (NASDAQ: SCYX) gab bekannt, dass es eine Meilensteinzahlung von 10 Millionen US-Dollar von GSK erhalten wird, die durch die Übergabe der endgültigen klinischen Studienberichte der abgeschlossenen FURI-, CARES- und NATURE-Studien ausgelöst wurde. Diese Zahlung ist Teil ihres exklusiven Lizenzvertrags für ibrexafungerp. Die Ergebnisse der FURI- und CARES-Studien sind positiv und konsistent mit früheren Zwischenanalysen. SCYNEXIS bekräftigt seine Liquidität von über zwei Jahren und plant, SCY-247, sein nächste Generation fungizid, später in diesem Jahr in klinische Studien zu bringen. Das Unternehmen hat zuvor 115 Millionen US-Dollar von GSK erhalten und ist berechtigt, bis zu 323 Millionen US-Dollar an weiteren potenziellen Zahlungen sowie gestaffelte Lizenzgebühren aus dem Verkauf von ibrexafungerp zu erhalten.
- Receiving $10 million milestone payment from GSK
- Positive results from FURI and CARES studies
- Cash runway exceeding two years
- Potential for additional $323 million in milestone payments from GSK
- Eligibility for tiered royalties on ibrexafungerp sales
- Ongoing supply chain issues for ibrexafungerp
- Delay in restarting Phase 3 MARIO study in invasive candidiasis
Insights
The $10 million milestone payment is a notable event for SCYNEXIS, demonstrating progress in their clinical pipeline and providing a financial boost. This payment, combined with their extended cash runway of over two years, indicates strong financial health and reduces immediate liquidity risks. Investors should note the robustness in SCYNEXIS's balance sheet, which suggests they are well-positioned to fund ongoing and future research without the need for additional capital raises in the near term. This stability can be seen as a positive indicator for potential future milestones and market performance of their stock.
The completion of the FURI, CARES and NATURE studies is significant in the context of advancing treatments for drug-resistant fungal infections. Positive results from these studies reinforce the therapeutic potential of ibrexafungerp, particularly in difficult-to-treat conditions where there is a high unmet medical need. This progress supports the clinical value of SCYNEXIS’s pipeline and can enhance their reputation in the biotech community, potentially leading to greater investor interest and higher valuation of their stock. Furthermore, the promise of future Phase 3 trials and presentations at scientific meetings can sustain long-term growth and innovation within the company.
SCYNEXIS's collaboration with GSK and the structured milestone payments are indicative of strategic partnerships that are important for smaller biotech firms. The potential for up to $323 million in future milestone payments and tiered royalties provides a clear revenue pathway. This partnership not only validates SCYNEXIS’s technological and research capabilities but also underscores the commercial viability of ibrexafungerp. For retail investors, the partnership with a major player like GSK adds a layer of credibility and reduces operational risks, making SCYNEXIS a more attractive investment opportunity in the biotech sector.
Reiterating cash runway of > 2 years
JERSEY CITY, N.J., July 23, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that it will receive a
"We are pleased to have completed these important studies in refractory invasive fungal infections, for which there remains an urgent need to deliver new solutions and combat growing resistance," said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. "Work continues to reestablish the supply chain of ibrexafungerp, and we look forward to restarting the Phase 3 MARIO study in invasive candidiasis. Our balance sheet remains robust, and our cash runway exceeds two years as we advance our next generation fungerp, SCY-247, into the clinic later this year."
Results from the open-label studies of ibrexafungerp in patients with refractory or resistant fungal diseases (FURI) and in patients with Candidiasis caused by Candida auris (CARES) are positive and consistent with previously announced interim analyses and are expected to be presented at a future scientific meeting. NATURE was an observational study to evaluate the outcome of patients with invasive candidiasis treated with available standard of care options and was designed as an external control strategy for the FURI study.
SCYNEXIS anticipates receiving the
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company’s proprietary antifungal platform “fungerps”. Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phase, including the compound SCY-247. For more information, visit www.scynexis.com.
Forward-Looking Statements
Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: SCYNEXIS’s expectation that it will have a cash runway of more than two years; anticipated advancement of SCY-247 into the clinic in 2024; and the resumption of the MARIO study. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 28, 2024, and form 10-Q for the quarter ending March 31, 2024, including under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
CONTACT:
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com
FAQ
What milestone triggered the $10 million payment from GSK to SCYNEXIS (SCYX)?
What were the results of the FURI and CARES studies for SCYNEXIS (SCYX)?
When does SCYNEXIS (SCYX) plan to advance SCY-247 into clinical trials?
What is the total potential value of the license agreement between SCYNEXIS (SCYX) and GSK for ibrexafungerp?
