Ibrexafungerp Citrate

In addition to its $22 million payout from GSK, Scynexis will collect another $2.3 million related to trial wind-down activities. Brexafemme (ibrexafungerp) partners GSK and Scynexis have worked out their quarrel related to a clinical trial that was previously put on hold, leaving Scynexis with a $22 million payout.Per the resolution, Scynexis will wind down its phase 3 MARIO study of Brexafemme in invasive candidiasis, the company said in an Oct. 15 press release. Besides the $22 million sum, the company stands to receive an additional $2.3 million related to trial wind-down activities, Scynexis said.Scynexis will not receive any further milestone payments from GSK in relation to the MARIO study.GSK is still on board with its Scynexis collaboration and plans to commercialize Brexafemme in its approved indications of vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC), according to Scynexis. After Scynexis transfers the drug’s regulatory application to GSK by the end of this year, the British company hopes to begin discussions with the FDA on a relaunch of the medicine.“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 CEO David Angulo, M.D., said in the release.GSK and Scynexis shook hands on a Brexafemme licensing deal in early 2023. Later that year, GSK found that the equipment used to make the drug was also used to produce a beta-lactam substance, which can trigger allergies in some people. Scynexis then recalled the drug due to the potential for cross-contamination.When the FDA lifted a clinical trial hold after 19 months this May, Scynexis quickly moved to resume the delayed study. GSK, for its part, wanted its partner to terminate the trial. GSK’s objections were still in play when Scynexis began dosing patients in the re-enrolled study, triggering a $10 million milestone payment under the original contract. GSK disputed the milestone but said it remained committed to marketing the drug.Brexafemme was approved in 2021 for VVC, bringing a new class of antifungal drugs to the indication. GSK paid Scynexis $90 million upfront to get in on the drug, but later cut down its milestone obligations as part of a 2024 deal amendment.

SCYNEXIS to receive a $22 million payment as part of the resolution related to the restart of the Phase 3 MARIO study on invasive candidiasisScynexis will promptly wind-down and terminate the MARIO studyThe payment from GSK, combined with cash in hand and removal of future MARIO expenditures, extends the company’s cash runway to more than two yearsGSK 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 SCYNEXISSCYNEXIS, 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 StatementsStatements 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 RelationsIrina KofflerLifeSci AdvisorsTel: 917-734-7387ikoffler@lifesciadvisors.com