Company: SCYX
Filing Date: 2025-05-15
Form Type: 10-Q
Source: 0000950170-25-072548
Chunk: 11

Company: SCYNEXIS INC
Filing Date: 2025-05-15
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 enfumafungin-derived antifungal compounds (“fungerps") as broad-spectrum, systemic antifungal agents for multiple fungal indications. Ibrexafungerp is the first representative of this novel class of antifungals with additional assets from the “fungerp” family under development, including SCY-247 which is currently in clinical stages of development.  In June 2021, the U.S. Food and Drug Administration (“FDA”) approved BREXAFEMME (ibrexafungerp tablets) for treatment of patients with vulvovaginal candidiasis, also known as vaginal yeast infection, and in December 2022, the Company announced that the FDA approved a second indication for BREXAFEMME for the reduction in the incidence of recurrent vulvovaginal candidiasis.As previously disclosed, the Company and GlaxoSmithKline Intellectual Property (No. 3) Limited (“GSK”) entered into 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”).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 ibrexafungerp to a new facility and has been working on generating new material with a goal of lifting the clinical hold and resuming the MARIO study.  New clinical supplies to enable the re-start of the MARIO study have been manufactured and information supporting the use of these supplies to re-start clinical activities was provided to the FDA. On April