SCYNEXIS Announces Q3 2024 Financial Results and Corporate Update

Clinical study reports for the FURI, CARES, and NATURE trials in refractory or resistant invasive fungal infections were delivered to GSK, triggering a $10 million development milestone payment to SCYNEXIS, received in Q3 2024. SCY-247 preclinical studies were presented at medical conferences and continue to show potent and broad antifungal activity. Phase 1 study initiation is anticipated in Q4 2024. SCYNEXIS ended Q3 2024 with cash, cash equivalents, and investments of $84.9 million, including the recently earned $10.0 million development milestone, and projects a cash runway into Q3 2026. SCYNEXIS will attend Guggenheim’s Inaugural Global Healthcare Conference in Boston on November 12th and hold one-on-one meetings with investors. JERSEY CITY, N.J., Nov. 06, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today reported financial results for the third quarter ended September 30, 2024.

SCYNEXIS announced significant progress in its partnered programs for ibrexafungerp, advancing the manufacturing of clinical trial materials to enable the restart of the Phase 3 MARIO trial in invasive candidiasis, expected in early 2025. David Angulo, M.D., President and CEO, highlighted the promising preclinical results of SCY-247 in a variety of invasive fungal infections, suggesting its potential as a new therapeutic agent. The company has shared these findings with the scientific community, most recently at IDWeek 2024, and plans to initiate a Phase 1 trial for SCY-247 in Q4 2024. SCYNEXIS has completed the FURI, CARES, and NATURE studies on ibrexafungerp for invasive fungal infections, yielding positive results that prompted a $10 million milestone payment from GSK in the third quarter.

Preclinical data from SCY-247 studies, showcased at medical conferences like the Mycoses Study Group Education & Research Consortium Biennial Meeting and IDWeek in 2024, demonstrated significant preclinical efficacy against invasive fungal infections. Highlights included dose-dependent efficacy in Candida albicans mouse models, significant reductions in fungal burden in kidney and lung tissues in Candida glabrata models, prolonged survival in pulmonary mucormycosis models, and high tissue distribution in organs critical for invasive fungal infections. Phase I trials of SCY-247 are expected to start in Q4 2024.

The delivery of final study reports from the FURI, CARES, and NATURE trials to GSK in July 2024 triggered a $10 million milestone payment to SCYNEXIS, received in Q3 2024. The results from these studies are expected to be presented by GSK at a future medical meeting. SCYNEXIS is also preparing for the third-party manufacturing of new ibrexafungerp batches for clinical trials, with plans to restart the Phase 3 MARIO trial in invasive candidiasis in early 2025.

SCYNEXIS will participate in Guggenheim Securities Healthcare Conference in Boston from November 11-13, 2024, engaging in one-on-one meetings with investors.

For the third quarter of 2024, SCYNEXIS reported revenues of $0.7 million from license agreements, compared to $2.4 million in the same period in 2023. Research and development expenses increased to $8.1 million from $6.5 million in Q3 2023, primarily due to higher costs in chemistry, manufacturing, and controls, preclinical expenses, and other R&D activities. SG&A expenses decreased to $2.9 million from $5.0 million in the same period in 2023, mainly due to lower professional and commercial expenses. Total other income was $7.1 million, down from $8.3 million in Q3 2023, largely due to adjustments in the fair value of warrant liabilities. The net loss for Q3 2024 was $2.8 million, compared to a $1.8 million net loss in Q3 2023.

SCYNEXIS had $84.9 million in cash, cash equivalents, and investments as of September 30, 2024, compared to $98.0 million on December 31, 2023. The company projects that its current resources will sustain operations into the third quarter of 2026.

Triterpenoid antifungals, or "fungerps," are a novel class of glucan synthase inhibitors with both oral and IV formulations, showing broad-spectrum antifungal activity against multidrug-resistant pathogens. Ibrexafungerp, the first compound from this class, is approved in the U.S. for vulvovaginal candidiasis and is in late-stage development for invasive candidiasis. SCY-247, another compound from the same class, is in preclinical development for treating severe, often drug-resistant fungal diseases, including Candida auris infections.

SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology firm focused on creating innovative treatments for difficult-to-treat and drug-resistant infections. The company's proprietary antifungal platform, "fungerps," includes ibrexafungerp, licensed to GSK, and approved by the FDA for specific candidiasis indications. The firm is also researching additional antifungal assets in preclinical and discovery phases.