Ibrexafungerp Citrate

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

Plus, news about Scynexis, Step Pharma, Eradivir, J&J, Omnix Medical and Mission Therapeutics: 💼 Boehringer Ingelheim does another cancer deal: The German drugmaker will pay up to $991 million to Seoul-based AimedBio for access to an antibody-drug conjugate that is slated to enter Phase 1 next year. The companies didn’t disclose any details about the ADC, other than saying it’s for cancer. Boehringer has done a series of deals in recent years to boost its oncology footprint, including with Nerio Therapeutics , Tessellate Bio and Accent Therapeutics. — Kyle LaHucik 👁️ EyePoint Pharmaceuticals’ $150M offering: The company is selling 11 million shares for $12.00 apiece to help progress Duravyu as a treatment for wet age-related macular degeneration and diabetic macular edema. — Jaimy Lee 💰 Scynexis gets $22M from GSK, to terminate Phase 3 trial: The biotech said the payment resolves a dispute with the British drugmaker, and it will now wind down the late-stage study testing SCY-247 in invasive candidiasis. The companies will continue to work together on vaginal infection drug Brexafemme, which was pulled from the market in 2023 over contamination concerns. The payment extends Scynexis’ cash runway for two years. Its stock price $SCYX was up 6% at market open on Wednesday. — Jaimy Lee 💶 Step Pharma’s €38M Series C: The money will help the French biotech continue work on its early-phase CTPS1 inhibitor called dencatistat in certain blood cancers and solid tumors. The raise was led by new investor V-Bio Ventures, with existing investors Bpifrance, Hadean Ventures, Inserm Transfert Initiative, Kurma Partners, Pontifax Venture Capital and Sunstone Life Science Ventures also pitching in. The biotech raised €35 million in 2021. — Reynald Castaneda Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. Hello Victoria Ward , Endpoints is fielding its next Pulse Poll — a one-minute check-in on how artificial intelligence is reshaping biopharma. Results are confidential and will feed into our coverage of AI's real-world impact. 🌡 Eradivir’s flu candidate clears Phase 2a trial: Influenza patients treated with a 300 mg dose of the biotech’s EV25 demonstrated a “significant reduction” in symptom duration and severity compared with placebo. Furthermore, more than 80% of placebo patients went on to develop lower respiratory tract infection versus about 35% of treated patients. Eradivir said it is planning to start a large Phase 2b study in the US and Europe during next year’s flu season. — Ayisha Sharma ⚠️ Johnson & Johnson’s Carvykti gets black box warning for intestinal inflammation: The FDA added the warning for immune effector cell-associated enterocolitis following cases reported in clinical trials and post-marketing data. The agency noted that some cases resulted in death from gut perforation and sepsis. The multiple myeloma CAR-T therapy’s label was also updated with overall survival benefit. J&J and Legend Biotech developed Carvykti. — Lei Lei Wu 💰 Omnix Medical’s $25M Series C: The Israeli company said the round was co-led by Harel Insurance & Finance and the EIC Fund. It’s developing a drug called OMN6 to treat infections caused by Acinetobacter baumannii and other Gram-negative bacteria. — Jaimy Lee 💸 Mission Therapeutics corrals $13.3M: The Cambridge, UK-based drugmaker will use the proceeds to run a Phase 1b study to investigate its lead asset, codenamed MTX325, for Parkinson’s disease. The study is set to start in the first half of 2026. Its latest raise is from existing investors. — Reynald Castaneda