Company: SCYX
Filing Date: 2025-08-13
Form Type: 10-Q
Source: 0000950170-25-107985
Chunk: 11

Company: SCYNEXIS INC
Filing Date: 2025-08-13
Form: 10-Q
Item: Part I, Item 8
Chunk 11
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(unaudited)

1.  Description of Business and Basis of PreparationOrganizationSCYNEXIS, Inc. ("SCYNEXIS" or the “Company”) is a Delaware corporation formed on November 4, 1999. SCYNEXIS is a biotechnology company, headquartered in Jersey City, New Jersey, and is pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections.  The Company is developing its proprietary class of triterpenoid antifungal compounds (“fungerps") as broad-spectrum, systemic antifungal agents for multiple fungal indications. Ibrexafungerp is the first representative of this novel class of antifungals and was approved by the U.S. Food and Drug Administration (“FDA”) as BREXAFEMME (ibrexafungerp tablets) for treatment of patients with vulvovaginal candidiasis and for the reduction in the incidence of recurrent vulvovaginal candidiasis in 2021 and 2022, respectively. A second generation fungerp SCY-247 is currently being evaluated in clinical trials with additional compounds from our proprietary fungerp platform, targeted to address significant unmet needs, in earlier stages of development.As previously disclosed, the Company licensed the rights for ibrexafungerp to GlaxoSmithKline Intellectual Property (No. 3) Limited (“GSK”) via an exclusive license agreement dated March 30, 2023, which was subsequently amended by a binding memorandum of understanding dated December 26, 2023 (collectively, the “GSK License Agreement”). Pursuant to the GSK License Agreement, the Company is responsible for conducting the MARIO study. As previously disclosed, the Phase 3 MARIO study of ibrexafungerp for the treatment of invasive candidiasis was placed on clinical hold in September 2023 following identification of a potential cross-contamination at the facility of the drug substance manufacturer in light of draft FDA guidance recommending that certain drugs be manufactured in separate facilities. One of these drugs, a non-antibiotic beta lactam drug called ezetimibe, was being manufactured at the same facility as ibrexafungerp. The Company has since moved the manufacture of the clinical supplies of ibrexafungerp to enable the continuation of the MARIO study to a new facility.  New clinical supplies to enable the re-start of the MARIO study were manufactured and on April 24, 2025, the FDA notified the Company that