SCYNEXIS Announces First Participants Dosed in a Phase 1 Single Ascending Dose and Multiple Ascending Dose Trial of Intravenous SCY-247

Results from IV Phase 1 SAD/MAD Trial Expected in 2026

JERSEY CITY, N.J., Feb. 26, 2026 (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 the first participants have been dosed in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial evaluating the intravenous formulation (IV) of its second-generation triterpenoid antifungal therapy, SCY-247, which is being developed as a treatment for invasive candidiasis (IC) and as a prophylaxis therapy for invasive fungal disease. Results from this trial are expected in 2026.

“Following the FDA’s recent decision to grant SCY-247 both Qualified Infections Disease Product and Fast Track designations, we are pleased to announce the dosing of the first cohort of participants in our Phase 1 SAD/MAD trial of IV SCY-247,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “An IV formulation of SCY-247 would provide additional flexibility for the optimal management of patients with invasive candidiasis and we are excited by the achievement of this important development milestone, which moves this innovative antifungal closer towards meeting the needs of patients suffering from difficult to treat severe fungal diseases."

In September 2025, the Company announced positive SAD/MAD data for the oral formulation of SCY-247, demonstrating its excellent pharmacokinetic and pharmacodynamic properties. Oral SCY-247 also achieved target exposures for invasive fungal disease at doses lower than first generation fungerps, which may confer distinct tolerability advantages. Based on its differentiated attributes and its potential role to counter health security threats posed by the continuous rise of antifungal resistance, SCYNEXIS continues to explore potential non-dilutive funding opportunities to further support the SCY-247 program.

On January 21, 2026, the Company announced that the U.S. Food and Drug Administration (FDA) granted SCY-247 both Qualified Infectious Disease Product (QIDP) and Fast Track designations.

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) has approved BREXAFEMME^® (ibrexafungerp tablets) for the treatment of vulvovaginal candidiasis (VVC) and for reduction in the incidence of recurrent VVC. The second generation fungerp SCY-247 is currently in clinical stages of development and has received QIDP and Fast Track designation from the FDA. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phases. 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: the results from the IV Phase 1 SAD/MAD trial expected in 2026; the benefits of an IV formulation and the potential for SCY-247 to meet the needs of patients; SCY-247 having the potential to significantly reduce fungal burden compared to other available antifungal therapies, including the azoles and echinocandins; and SCY-247’s potential role to counter health security threats posed by antifungal resistance development. 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
ikoffler@lifesciadvisors.com

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