SCYNEXIS Announces Advancement of Ibrexafungerp’s Intravenous Formulation to Clinical Stage and Provides Further Updates on its Clinical Studies in Patients with Life-Threatening Fungal Infections

Approval granted by health authority for the intravenous (IV) formulation of ibrexafungerp to enter Phase 1; dosing in healthy volunteers to start in the first quarter of 2021New interim analysis of the data from the Phase 3 studies of ibrexafungerp in refractory invasive fungal infections (FURI and CARES) expected in the first quarter of 2021; additional 43 patients will double the existing dataset of 41 cases already analyzedAnalysis of the CARES study will provide the first clinical trial data of an investigational treatment against infections caused by Candida auris, a multidrug-resistant fungus deemed an urgent threat by the CDC
JERSEY CITY, N.J., Dec. 10, 2020 (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 significant progress on the ibrexafungerp IV formulation and provided an update on its ongoing Phase 3 studies in the hospital setting.(1) Liposomal IV formulation of ibrexafungerp entering Phase 1 study(2) New interim analysis of Phase 3 FURI and CARES open-label studies expected in the first quarter of 2021, doubling the existing dataset of patient cases“As we prepare for our first commercial launch of oral ibrexafungerp in the community setting in 2021, we are also excited about advancing ibrexafungerp for patients with serious and life-threatening infections in the hospital setting,” said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “The analysis of our CARES study will provide the first clinical trial data of an investigational treatment against Candida auris, a multidrug-resistant fungus deemed an urgent threat by the CDC. When approved, ibrexafungerp would represent the first new antifungal class in over 20 years and, with the advancement of our IV formulation, ibrexafungerp could become the first new class offering the flexibility of both IV and oral formulations in over 40 years.”About SCYNEXISForward Looking StatementStatements 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 expected timing of dosing of volunteers and patients and reporting of interim analyses. 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 SCYNEXIS’s ability to successfully obtain regulatory approval to commence dosing of ibrexafungerp; SCYNEXIS’s need for additional capital resources; and SCYNEXIS’s reliance on third parties to conduct SCYNEXIS’s clinical studies. These and other risks are described more fully in SCYNEXIS’s filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K and Form 10-Q under the caption “Risk Factors” and other documents subsequently filed with or furnished to the Securities and Exchange Commission. 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.comMedia Relations
Gloria Gasaatura
LifeSci Communications
Tel: (646) 970-4688
ggasaatura@lifescicomms.com
