SCYNEXIS(US:SCYX)2025-03-12 20:55Financial Performance - For the year ended December 31, 2024, total revenue was $3.7 million, a decrease of 97.3% from $140.1 million in 2023, primarily due to a significant drop in license agreement revenue[315]. - The net loss for the year ended December 31, 2024, was $21.3 million, compared to a net income of $67.0 million in 2023, representing a decline of $88.3 million or 131.8%[315]. - Research and development expenses decreased to $26.4 million in 2024 from $30.9 million in 2023, a reduction of $4.5 million or 14.6%[317]. - Selling, general and administrative expenses decreased to $14.5 million in 2024 from $20.9 million in 2023, a decrease of $6.5 million or 30.9%[319]. - The company recognized $4.3 million in interest income for the year ended December 31, 2024, an increase from $4.0 million in 2023[322]. - The fair value adjustment for warrant liabilities resulted in a gain of $13.8 million in 2024, compared to a loss of $3.2 million in 2023[324]. - Stock-based compensation expense for the year ended December 31, 2024, totaled $3.346 million, an increase from $2.624 million in 2023[351]. Cash Flow and Capital Requirements - As of December 31, 2024, cash, cash equivalents, and investments totaled approximately $75.1 million, down from $98.0 million as of December 31, 2023[326]. - Net cash used in operating activities was $24.0 million for the year ended December 31, 2024, primarily due to the net loss adjusted for non-cash charges[330]. - The company received a $10.0 million development milestone under the GSK License Agreement in 2024, compared to $115.0 million received in the prior period[329]. - The company anticipates continued losses for several years, driven by significant research and development and administrative expenses, indicating a potential need for additional capital[327]. - The company anticipates substantial additional funding will be needed for ongoing research, development, and clinical trials of product candidates[334]. - Future capital requirements will depend on achieving development, regulatory, and commercial milestones under the GSK License Agreement[336]. - The company expects to finance cash needs through equity offerings, debt financings, or non-dilutive third-party funding, which may dilute existing stockholder interests[338]. Research and Development - Research and development expenses are expected to remain significant as SCYNEXIS continues to develop ibrexafungerp and SCY-247, with no reasonable estimate of the costs required to complete their development[309][310]. - The FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to ibrexafungerp for multiple indications, which may provide additional market exclusivity[289]. - SCY-247, a second-generation antifungal compound, is currently in clinical development with a Phase 1 study initiated in Q4 2024[288][299]. - The company recalled BREXAFEMME due to potential cross-contamination risks and is working with the FDA to resolve the clinical hold on ibrexafungerp studies[296][298]. - SCYNEXIS anticipates restarting the Phase 3 MARIO study for ibrexafungerp in Q2 2025 after addressing the FDA's concerns[298]. - The company has entered into new manufacturing agreements to produce new batches of ibrexafungerp to lift the clinical hold[298]. Legal and Regulatory Matters - A securities class action lawsuit was filed against SCYNEXIS alleging misleading statements regarding the manufacturing process of ibrexafungerp[303]. Market and Financial Position - As of December 31, 2024, SCYNEXIS reported cash, cash equivalents, and investments totaling $75.1 million, with an accumulated deficit of $376.5 million[304][305]. - The company recorded a net unfavorable change in operating assets and liabilities of $30.6 million, primarily due to a $31.5 million increase in operating assets[331]. - The weighted average expected volatility for employee stock options increased to 80.94% in 2024 from 74.77% in 2023[350].