SCYNEXIS(SCYX) - 2025 Q3 - Quarterly Report

Drug Development - SCYNEXIS, Inc. is developing a proprietary antifungal platform called "fungerps," targeting drug-resistant infections, with a focus on triterpenoids that inhibit glucan synthase[64]. - Ibrexafungerp, approved as BREXAFEMME, is indicated for vulvovaginal candidiasis (VVC) and recurrent VVC, with approvals received in 2021 and 2022[65]. - The company is progressing the development of SCY-247, a second-generation fungicide, which has shown potent activity against multidrug-resistant strains in preclinical models[66][72]. - SCY-247 has demonstrated favorable pharmacokinetics, with dose-proportional absorption and efficacy against resistant strains, supporting its continued clinical development[78]. - The company plans to initiate a Phase 1 study for the intravenous formulation of SCY-247 in Q1 2026, with a subsequent Phase 2 study for invasive candidiasis[79]. - SCYNEXIS is committed to addressing unmet medical needs in antifungal treatments, particularly for invasive candidiasis, which has a mortality rate exceeding 30%[74][71]. Financial Performance - License agreement revenue for the three months ended September 30, 2025, was $0.3 million, a decrease of 49.4% from $0.7 million in 2024[91]. - Research and development expenses decreased to $5.5 million for the three months ended September 30, 2025, down 32.5% from $8.1 million in 2024[92]. - Total operating expenses for the three months ended September 30, 2025, were $8.7 million, a decrease of 20.4% from $11.0 million in 2024[91]. - Net loss for the three months ended September 30, 2025, was $8.6 million, an increase of 205.9% from a net loss of $2.8 million in 2024[91]. - For the nine months ended September 30, 2025, license agreement revenue was $2.0 million, a decrease of 29.4% from $2.8 million in 2024[99]. - Research and development expenses for the nine months ended September 30, 2025, decreased to $17.7 million, down 19.7% from $22.1 million in 2024[100]. - Selling, general and administrative expenses increased to $10.8 million for the nine months ended September 30, 2025, an increase of 11% from $9.7 million in 2024[102]. - As of September 30, 2025, cash and cash equivalents were $37.9 million, down from $75.1 million as of December 31, 2024[108]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $23.7 million, compared to $14.1 million in 2024[110]. - The accumulated deficit as of September 30, 2025, was $397.4 million[108]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $23.7 million, primarily due to a net loss of $20.9 million adjusted for non-cash charges[112]. - The net unfavorable change in operating assets and liabilities for the same period was $0.7 million, resulting from a $2.0 million favorable change in operating assets offset by a $2.7 million unfavorable change in operating liabilities[112]. - For the nine months ended September 30, 2024, net cash used in operating activities was $14.1 million, with a net loss of $16.9 million adjusted for non-cash charges[113]. - The net favorable change in operating assets and liabilities for the nine months ended September 30, 2024, was $10.8 million, driven by a $16.2 million decrease in operating assets[114]. - Net cash provided by investing activities for the nine months ended September 30, 2025, was $36.1 million from maturities of investments[115]. - Net cash used in financing activities for the nine months ended September 30, 2025, was $14.1 million, primarily due to the repayment of $14.0 million in convertible debt[116]. Funding and Compliance - The company anticipates substantial additional funding will be required for ongoing research, development, and clinical trials of product candidates[117]. - Future capital requirements will depend on various factors, including regulatory approvals and the progress of clinical development of SCY-247[119]. - The company expects to finance cash needs through equity offerings, debt financings, or other non-dilutive funding sources until substantial revenue is generated[120]. - Management's estimates and judgments are based on historical experience and other factors, which may differ from actual results under different conditions[121]. - The company received a Nasdaq notification regarding its stock price falling below $1.00, with a compliance period until December 17, 2025, to regain compliance[80][81]. Legal Matters - The company has faced legal challenges, including a securities class action lawsuit, which was dismissed, indicating ongoing legal scrutiny[82].