Scynexis to receive $24.3 million from GSK as MARIO study ends per new agreement

Scynexis, Inc. (NASDAQ:SCYX), a biotechnology company currently valued at $34 million, announced Wednesday it has entered into a binding memorandum of understanding with GlaxoSmithKline Intellectual Property (No. 3) Limited (GSK) to amend their exclusive license agreement. The update, reported in a press release statement and detailed in a Securities and Exchange Commission filing, resolves a previously disclosed disagreement related to the Phase 3 MARIO study of ibrexafungerp for the treatment of invasive candidiasis. According to InvestingPro data, Scynexis maintains a strong financial position with more cash than debt and a healthy current ratio of 5.2.

As part of the new agreement, Scynexis will wind down and terminate the MARIO study. In connection with this, the company will receive a $22 million payment from GSK, as well as an additional $2.3 million for activities related to the wind-down and termination. Scynexis will not receive further milestone payments from GSK specifically associated with the MARIO study. The company’s stock, which has declined about 33% year-to-date and currently trades at $0.81, appears undervalued according to InvestingPro Fair Value metrics.

The original exclusive license agreement, signed March 30, 2023 and previously amended December 26, 2023, granted GSK exclusive, royalty-bearing rights to develop, manufacture, and commercialize ibrexafungerp, including the approved product Brexafemme, outside Greater China and certain other countries. While analysts project a sales decline for the current year, InvestingPro subscribers have access to 8 additional key insights about Scynexis’s financial health and growth prospects.

GSK reiterated its intention to continue collaborating with Scynexis under the broader license agreement, particularly regarding the commercialization of Brexafemme (ibrexafungerp tablets) for vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC) indications. Scynexis stated it is progressing with the transfer of the Brexafemme New Drug Application (NDA) to GSK, with completion expected by the end of 2025. GSK anticipates initiating regulatory discussions with the U.S. Food and Drug Administration in 2026 to address a potential relaunch of Brexafemme for VVC and rVVC in the United States.

Except for the changes regarding the MARIO study, the agreement does not alter other potential milestones and royalties payable to Scynexis under the existing license terms, including those linked to sales of Brexafemme for VVC and rVVC.

This summary is based on information provided in a press release statement and a recent SEC filing.

In other recent news, SCYNEXIS, Inc. announced positive results from a Phase 1 study of its antifungal drug SCY-247. The study assessed the safety, tolerability, and pharmacokinetics of the orally administered drug in healthy participants. Notably, there were no serious or severe treatment-emergent adverse events reported across all evaluated single and multiple ascending dose cohorts. This development marks a significant step forward in the drug’s clinical evaluation. While the announcement primarily focuses on the drug’s safety profile, it signals progress in SCYNEXIS’s ongoing research efforts. The company continues to advance its pipeline with this promising candidate. These updates reflect SCYNEXIS’s commitment to addressing unmet medical needs in the antifungal treatment space.

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