SCYNEXIS will receive $22 million from GSK, concluding the Phase 3 MARIO study and extending its cash runway.
Quiver AI Summary
SCYNEXIS, Inc. announced it will receive a $22 million payment from GlaxoSmithKline (GSK) related to the resolution of a disagreement over the Phase 3 MARIO study on invasive candidiasis, which SCYNEXIS will now terminate. This payment, along with existing cash and the elimination of future study expenses, extends the company's financial runway to over two years. While they won't receive further milestone payments tied to MARIO, GSK confirmed its commitment to collaborate on the commercialization of BREXAFEMME (ibrexafungerp tablets) for vulvovaginal candidiasis. SCYNEXIS is also working on transferring the BREXAFEMME NDA to GSK by the end of 2025 and anticipates regulatory discussions with the FDA for its relaunch in 2026. Despite the disappointment over the MARIO study, SCYNEXIS remains focused on developing new antifungal treatments, including SCY-247.
Potential Positives
- SCYNEXIS will receive a $22 million payment from GSK, enhancing its financial position.
- Termination of the MARIO study allows the company to eliminate future expenditures associated with it, extending its cash runway to more than two years.
- GSK has reaffirmed its commitment to the commercialization of BREXAFEMME, indicating a continued collaboration and potential revenue stream for SCYNEXIS.
- The progress in transferring the BREXAFEMME NDA to GSK suggests potential for future regulatory interactions and market relaunch opportunities in 2026.
Potential Negatives
- SCYNEXIS will not receive additional milestone payments from GSK associated with the termination of the MARIO study, potentially impacting future revenue streams.
- The abrupt wind-down of the MARIO study may signal challenges in the company's clinical development efforts and raise concerns about its research pipeline.
- The statement of disappointment regarding the MARIO study hints at potential internal setbacks for SCYNEXIS, which could affect investor confidence.
FAQ
What is the latest news about SCYNEXIS and the MARIO study?
SCYNEXIS will receive a $22 million payment from GSK as part of resolving the Phase 3 MARIO study on invasive candidiasis.
How does this payment affect SCYNEXIS's financial outlook?
The payment, along with existing cash reserves, extends SCYNEXIS’s cash runway to over two years by eliminating future MARIO expenditures.
What is GSK's commitment to SCYNEXIS after the MARIO study termination?
GSK remains committed to commercializing BREXAFEMME for vulvovaginal candidiasis and continuing collaboration under the GSK License Agreement.
What is BREXAFEMME and its significance?
BREXAFEMME (ibrexafungerp tablets) is an antifungal approved by the FDA for treating vulvovaginal candidiasis and is significant for addressing recurring infections.
What future plans does SCYNEXIS have for their antifungal research?
SCYNEXIS is developing SCY-247, a second-generation antifungal aimed at treating and preventing invasive fungal infections.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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SCYNEXIS to receive a $22 million payment as part of the resolution related to the restart of the Phase 3 MARIO study on invasive candidiasis
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Scynexis will promptly wind-down and terminate the MARIO study
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The payment from GSK, combined with cash in hand and removal of future MARIO expenditures, extends the company’s cash runway to more than two years
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GSK remains committed to the commercialization of BREXAFEMME (ibrexafungerp tablets)
JERSEY CITY, N.J., Oct. 15, 2025 (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 $22 million payment from GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK) as part of a resolution of the disagreement with GSK related to the restart of the Phase 3 MARIO study on invasive candidiasis. SCYNEXIS will not receive additional milestone payments from GSK associated with the MARIO study. SCYNEXIS will promptly commence appropriate wind-down activities associated with its termination and will receive an additional $2.3M payment in connection with these activities.
GSK has also reiterated its commitment to continued collaboration with SCYNEXIS regarding other aspects of the GSK License Agreement, including with respect to the commercialization of BREXAFEMME (ibrexafungerp tablets) for the vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC) indications. SCYNEXIS continues to progress the transfer of the BREXAFEMME NDA to GSK by the end of 2025. GSK anticipates being able to initiate regulatory interactions with the U.S. Food and Drug Administration in 2026 to discuss the relaunch of BREXAFEMME for VVC and rVVC in the U.S. market.
“While disappointed that the MARIO study will not continue, we’re pleased to have resolved this disagreement with GSK and that it remains committed to relaunching BREXAFEMME. SCYNEXIS remains committed to developing novel antifungal solutions, including SCY-247, its second-generation triterpenoid antifungal under development for the treatment and prevention of invasive fungal infections with the potential to provide the therapeutic advantages of both an oral and IV formulation,” said David Angulo, M.D., President and Chief Executive Officer. “We want to thank all of the patients who participated in the MARIO study and the investigators for their continued support toward finding new antifungal agents in areas of significant unmet need.”
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. Additional antifungal assets from this novel class are currently in clinical, pre-clinical and discovery phases, 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: any advantages of SCY-247 over existing antifungals, continued development of SCY-247, and the Company’s cash runway. 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 12, 2025, 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: 917-734-7387
[email protected]