Company: SCYX
Filing Date: 2025-11-05
Form Type: 10-Q
Source: 0001178253-25-000010
Chunk: 8

Company: SCYNEXIS INC
Filing Date: 2025-11-05
Form: 10-Q
Item: Part I, Item 8
Chunk 8
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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 ("VVC") and for the reduction in the incidence of recurrent vulvovaginal candidiasis ("rVVC") in 2021 and 2022, respectively. 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 the binding memorandums of understanding dated December 26, 2023 and October 14, 2025 (collectively, the “GSK License Agreement”).  See Notes 10 and 12 for further details.A second generation fungerp SCY-247 is currently being evaluated in clinical trials and additional compounds from the Company's proprietary fungerp platform, targeted to address significant unmet needs, are in earlier stages of development.  The Company recently completed the single and multiple ascending dose portions of the ongoing Phase 1 study of oral SCY-247.  Following the positive results of the oral formulation, the Company intends to initiate a Phase 1 study of the intravenous formulation in the first quarter of 2026.  A clinical proof-of-concept Phase 2 study in patients with invasive candidiasis is also anticipated in 2026.  Subsequent stages of development are anticipated to include studies adequate to support an invasive candidiasis treatment indication, as well as evaluating SCY-247 for the prevention of invasive fungal diseases in patients at high risk.  The Company owns 100% of the rights to SCY-247 as well as the additional fungerp compounds. The