SCYNEXIS to Get $10M Milestone Payment from GSK for Completed Clinical Study Reports

SCYNEXIS, Inc., a biotechnology firm headquartered in Jersey City, New Jersey, announced its acquisition of a $10 million development milestone payment from GSK under their exclusive licensing agreement for ibrexafungerp. This payment is a result of the completion of final clinical study reports for the FURI, CARES, and NATURE studies.

David Angulo, M.D., the President and CEO of SCYNEXIS, expressed satisfaction in completing the vital studies on refractory invasive fungal infections, highlighting the urgent need for new treatments to combat increasing resistance. Angulo also emphasized ongoing efforts to reestablish the ibrexafungerp supply chain and signaled the restart of the Phase 3 MARIO study targeting invasive candidiasis. He reassured stakeholders of the company's strong financial position, with a cash runway exceeding two years, and announced the planned clinical introduction of the next-generation fungerp, SCY-247, later in the year.

The FURI study focused on patients with refractory or drug-resistant fungal infections, while the CARES study examined patients suffering from Candidiasis caused by Candida auris. Both studies yielded positive results, consistent with previous interim analyses, and their findings are expected to be showcased at a forthcoming scientific event. Additionally, the NATURE study, an observational analysis, assessed outcomes for patients with invasive candidiasis treated with standard care options, serving as an external control for the FURI study.

SCYNEXIS expects to receive the $10 million milestone payment in the third quarter of 2024. According to the exclusive license agreement with GSK, SCYNEXIS has already received $115 million in upfront and development milestone payments and could receive up to an additional $323 million in potential milestone-based payments, bringing the total deal value to $448 million. GSK will also provide tiered royalties ranging from mid-single digits to mid-teens on all ibrexafungerp sales across various indications.

SCYNEXIS is committed to developing pioneering medicines to tackle challenging drug-resistant fungal infections. The company’s primary antifungal platform, termed “fungerps,” includes ibrexafungerp, now licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME® (ibrexafungerp tablets) in June 2021 for treating vulvovaginal candidiasis (VVC), with a second approval in November 2022 for reducing recurrent VVC incidences. Clinical investigations into ibrexafungerp for treating severe invasive fungal infections in hospitalized patients are ongoing. In addition to ibrexafungerp, SCYNEXIS is developing other antifungal compounds, including SCY-247, which are currently in pre-clinical and discovery stages.