Ibrexafungerp Citrate

Intravenous SCY-247 was generally well tolerated in healthy participants, with no drug-related serious adverse events Once-daily intravenous doses of 50 mg or higher achieved exposures at or above the target identified in murine models of invasive candidiasis Company expects to initiate Phase 2 development of SCY-247 in oral and IV formulations in 2027, subject to regulatory agreement SCY-247 development is advancing with the support of a BARDA contract providing up to approximately $214 million in non-dilutive funding if milestones are achieved JERSEY CITY, N.J., Oct. 22, 2026 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX) (“SCYNEXIS”, or the “Company”), a clinical-stage biotechnology company dedicated to advancing innovative solutions for severe rare diseases, today announced topline results from its Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial of the intravenous (IV) formulation of SCY-247, its second-generation triterpenoid (fungerp) antifungal candidate. SCY-247 is under development in both oral and intravenous (IV) formulations for the treatment and prevention of invasive fungal infections with the potential to provide therapeutic advantages by having activity against drug-resistant fungi. “With Phase 1 studies of both the intravenous and oral formulations of SCY-247 now complete, we can refine our plans for the next stage of development of this second-generation fungerp, designed to address the growing threat of antimicrobial resistance,” said Todd Minga, M.D., SVP of Research and Development at Scynexis. “Having both intravenous and oral formulations could provide flexibility in managing patients with invasive candidiasis and those at risk of invasive fungal diseases. We look forward to initiating a Phase 2 study next year, subject to agreement with the FDA." Recently, Scynexis was awarded a BARDA contract (75A50126C00007) providing up to approximately $214 million in non-dilutive funding, if milestones are achieved, to advance the development of SCY-247. The award is structured as a cost-share arrangement, with BARDA providing support for eligible SCY-247 costs. The Company expects to fund its share of near-term program costs for SCY-247 within its existing operating plan. The Company’s previously communicated development plans for SCY-770 to initiate a Phase 2 study in the fourth quarter of 2026 and the Company’s projected cash runway into 2029 remain unchanged. Phase 1 Study Results The study evaluated the safety and characterized the pharmacokinetics of intravenous SCY-247 to inform progression to, and dose selection for, a Phase 2 study in patients with invasive candidiasis. The Phase 1 study enrolled 56 healthy participants across seven cohorts: 42 received SCY-247 by peripheral intravenous infusion and 14 received placebo. The study evaluated single ascending doses up to 300 mg and multiple ascending doses administered once daily for seven days up to 200 mg. SCY-247 administered by peripheral intravenous infusion was generally well tolerated. The most commonly reported adverse reactions were mild to moderate erythema and pain at the infusion site. There were no drug-related serious adverse events or discontinuations due to a related adverse event. Intravenous doses of 50 mg once daily or higher achieved exposures at or above the efficacy target identified in murine models of invasive candidiasis (AUC 0–24 of 20 µg·h/mL). A previously completed Phase 1 study indicated that oral doses of 100 mg or higher are also anticipated to achieve the target exposure for efficacy. Overall, the safety, tolerability, and pharmacokinetic pro in this study support the continued clinical development of SCY-247. Further details of the results from this study will be presented at an upcoming scientific meeting. Invasive candidiasis is associated with high mortality, and resistance to the limited available antifungal options is making treatment increasingly challenging. Designed to address these limitations, SCY-247 has demonstrated in vitro and in vivo activity against several challenging Candida strains, including Candida auris , as well as most azole- and echinocandin-resistant strains. SCY-247 has been granted Orphan Drug, Qualified Infectious Disease Product (QIDP) and Fast Track designations by the U.S. Food and Drug Administration. Future activities for this project may be funded in whole or in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Center for the Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50126C00007. About SCY-247 SCY-247 is a second-generation triterpenoid (fungerp) antifungal candidate being developed for the treatment of invasive candidiasis and the prevention of invasive fungal diseases. As a member of a novel structural class, SCY-247 has a differentiated mechanism of action from existing antifungal classes and has demonstrated in vitro activity against a broad range of fungal pathogens, including strains resistant to currently available therapies. SCY-247 has been granted Orphan Drug, Qualified Infectious Disease Product (QIDP) and Fast Track designations by the U.S. Food and Drug Administration. Recently, Scynexis was awarded a BARDA contract (75A50126C00007) providing up to approximately $214 million in non-dilutive funding to advance the development of SCY-247. About SCYNEXIS SCYNEXIS, Inc. (NASDAQ: SCYX) is a clinical-stage biotechnology company dedicated to advancing innovative solutions for severe rare diseases. SCY-770 is being developed for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) and has been granted Orphan Drug designation. SCYNEXIS’s proprietary antifungal platform “fungerps” includes BREXAFEMME® (ibrexafungerp tablets), the first approved representative of this novel class, which has been licensed to GSK, and SCY-247, currently in clinical stages of development for the treatment and prevention of invasive fungal diseases. For more information, visit 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: the Company’s expectation to initiate Phase 2 development of SCY-247 in oral and IV formulations in 2027, subject to regulatory agreement; the potential for SCY-247 to provide therapeutic advantages of both an oral and IV formulation; the amount and timing of any BARDA funding (under contract 75A50126C00007); the Company’s expectation to fund its share of near-term program costs for SCY-247 within its existing operating plan; the anticipated initiation of the SCY-770 Phase 2 study in Q4 of 2026; the statements concerning the Company’s cash runway into 2029, and other statements identified by words such as “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. 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, including the risk that SCYNEXIS may not reach alignment with the FDA on the planned Phase 2 study designs on the anticipated timelines or at all, and the risk that BARDA does not exercise one or more options under the BARDA contract (75A50126C00007). For the Company, this includes the future prospects of the Company’s SCY-247 and SCY-770 programs, the timing and results of the Company’s anticipated Phase 2 clinical studies, stock price volatility and uncertainties relating to the financial markets, the medical community and the global economy, and the impact of instability in general business and economic conditions, including changes in inflation and interest rates. These and other risks are described more fully in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including without limitation, its most recent Annual Report on Form 10-K filed on March 4, 2026, including under the caption “Risk Factors,” and in other filings the Company makes with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company 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 John Fraunces LifeSci Advisors Tel: 917-355-2395 jfraunces@lifesciadvisors.com