Core Viewpoint - SCYNEXIS, Inc. reported its financial results for the year ended December 31, 2024, highlighting significant developments in its antifungal drug pipeline and a notable decrease in both revenue and expenses compared to the previous year [1][5][11]. Financial Performance - Total revenue for 2024 was $3.7 million, a decrease from $130.1 million in 2023, primarily due to the recognition of license agreement revenue associated with GSK [5][11]. - 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% [6]. - Selling, general and administrative expenses also saw a decrease to $14.5 million in 2024 from $20.9 million in 2023, a decline of $6.5 million or 30.9% [9]. - The net loss for 2024 was $21.3 million, translating to a basic loss per share of $0.44, compared to a net income of $67.0 million and earnings per share of $1.40 in 2023 [11][18]. Cash Position - As of December 31, 2024, the company had cash, cash equivalents, and investments totaling $75.1 million, down from $98.0 million at the end of 2023, providing a cash runway into Q3 2026 [12][18]. Drug Development Updates - The company initiated a Phase 1 trial for its second-generation antifungal SCY-247 in December 2024, with results expected in Q3 2025 [2][7]. - SCYNEXIS is making progress towards restarting the Phase 3 MARIO trial for invasive candidiasis, pending the FDA's lifting of the clinical hold anticipated in Q2 2025 [2][6][7]. - The company received a $10 million milestone payment from GSK in 2024, linked to the delivery of final study reports from completed studies [7]. Antifungal Platform - SCYNEXIS is developing a proprietary antifungal platform known as "fungerps," with Ibrexafungerp being the first approved agent for vulvovaginal candidiasis and in late-stage development for invasive candidiasis [13][14]. - SCY-247 is positioned as a next-generation fungicide targeting multi-drug-resistant fungal infections, including Candida auris [13].

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2024 OR UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-36365 SCYNEXIS, Inc. (Exact name of registrant as specified in its charter) Delaware 56-2181648 (State or other jurisdiction of incor ...

JERSEY CITY, N.J., Dec. 18, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that it has completed the dosing of the first cohort of subjects in its Phase 1 trial of SCY-247, the Company's second-generation triterpenoid antifungal in development for the treatment of severe invasive fungal infections.   "We are pleased to advance our potent, second-generation ...

Core Insights - SCYNEXIS has made significant progress in its clinical trials for antifungal treatments, particularly with ibrexafungerp and SCY-247, leading to a $10 million milestone payment from GSK [1][4][7]. Financial Performance - As of Q3 2024, SCYNEXIS reported cash, cash equivalents, and investments totaling $84.9 million, projecting a cash runway into Q3 2026 [2][14]. - Revenue for Q3 2024 was $0.7 million, a decrease from $2.4 million in Q3 2023, primarily due to lower license agreement revenue [9]. - Research and development expenses increased by 25% to $8.1 million in Q3 2024 compared to $6.5 million in Q3 2023, driven by higher costs in chemistry, manufacturing, and controls [10]. - Selling, general, and administrative expenses decreased by 42% to $2.9 million in Q3 2024 from $5.0 million in Q3 2023 [11]. - The net loss for Q3 2024 was $2.8 million, or $0.06 per share, compared to a net loss of $1.8 million, or $0.04 per share, in Q3 2023 [13][20]. Clinical Development - The FURI, CARES, and NATURE trials for ibrexafungerp in refractory invasive fungal infections have been completed, with positive results leading to the milestone payment [1][4][7]. - SCY-247 has shown promising preclinical results, with a Phase 1 study expected to begin in Q4 2024 [5][6]. - The Phase 3 MARIO trial for invasive candidiasis is anticipated to restart in early 2025 [4][8]. Upcoming Events - SCYNEXIS will participate in the Guggenheim's Inaugural Global Healthcare Conference in Boston on November 12, 2024, where management will hold one-on-one meetings with investors [2][8].

Financial Performance - Total revenue for the three months ended September 30, 2024, was $660,000, a decrease of 62.5% compared to $1.76 million in the same period of 2023[81]. - License agreement revenue for the three months ended September 30, 2024, was $660,000, down 72.2% from $2.375 million in 2023[81]. - Net loss for the three months ended September 30, 2024, was $2.8 million, an increase of 59.8% compared to a net loss of $1.76 million in 2023[81]. - Total revenue for the nine months ended September 30, 2024, was $2.769 million, a significant decrease of 97.9% from $134.344 million in the same period of 2023[85]. - Research and development expenses for the nine months ended September 30, 2024, were $22.1 million, an increase of 8.6% from $20.3 million in 2023[85]. - Selling, general and administrative expenses for the nine months ended September 30, 2024, decreased by 43.8% to $9.7 million from $17.3 million in 2023[85]. - The company recognized a $0.4 million income tax benefit for U.S. federal income tax for the three months ended September 30, 2024[83]. - The amortization of debt issuance costs and discount for the three months ended September 30, 2024, was $441,000, an increase of 22.5% from $360,000 in 2023[81]. - Net cash used in operating activities for the nine months ended September 30, 2024, was $14.1 million, a decrease of $82.0 million compared to the same period in 2023, primarily due to $115.0 million received under the GSK License Agreement in the prior period[86]. - Interest income increased to $3.4 million for the nine months ended September 30, 2024, compared to $2.6 million in the same period of 2023, driven by earnings from money market funds and investments[87]. - Interest expense decreased significantly to $0.6 million for the nine months ended September 30, 2024, down from $2.9 million in the prior year, due to the repayment of the Loan Agreement in May 2023[87]. - The company recognized a gain of $10.6 million in fair value adjustments related to warrant liabilities for the nine months ended September 30, 2024, compared to a loss of $6.0 million in the same period of 2023[87]. Research and Development - The accumulated deficit as of September 30, 2024, was $372.1 million, indicating ongoing significant research and development expenses[73]. - Ibrexafungerp, the first antifungal from SCYNEXIS's proprietary platform, has received FDA approval for treating vulvovaginal candidiasis and reducing recurrent cases[67]. - SCY-247, a second-generation antifungal, is in preclinical development, with a Phase 1 study anticipated to start in Q4 2024[67]. - Research and development expenses increased to $8.1 million for the three months ended September 30, 2024, representing a 24.9% increase from $6.5 million in 2023[81]. - The company expects to incur significant research and development expenses and may require additional capital to fund operations, which could be obtained through equity offerings, debt financings, or strategic alliances[91]. - Future capital requirements will depend on various factors, including the success of product candidates in clinical development and the ability to secure regulatory approvals[93]. Legal Matters - Legal proceedings have been initiated against SCYNEXIS regarding alleged misleading statements related to ibrexafungerp manufacturing processes[70]. - The company is facing legal proceedings related to alleged misstatements about its operations and internal controls, which could impact its financial position[95]. - A securities class action was filed on November 7, 2023, alleging materially false and misleading statements from March 31, 2023, to September 22, 2023[95]. - The class action complaint claims that the company failed to disclose risks related to cross-contamination in manufacturing processes[95]. - The complaint seeks unspecified damages on behalf of all persons who purchased shares between March 31, 2023, and September 22, 2023[95]. - Shareholder derivative complaints were filed on May 1, 2024, and June 4, 2024, based on the same alleged misstatements as the class action[95]. - The company intends to vigorously defend against the allegations made in the lawsuits[95]. Operational Updates - SCYNEXIS received a $10.0 million development milestone from GlaxoSmithKline (GSK) in Q3 2024, totaling $125.0 million received under the GSK License Agreement[67]. - A voluntary recall of BREXAFEMME was initiated due to potential cross-contamination risks, affecting ongoing clinical studies[69]. - The FDA has placed a clinical hold on ibrexafungerp studies, with plans to resolve the issue and restart the Phase 3 MARIO study in Q1 2025[69]. - SCYNEXIS has entered into new manufacturing agreements to produce ibrexafungerp batches to lift the clinical hold[69]. - As of September 30, 2024, SCYNEXIS, Inc. reported cash, cash equivalents, and investments totaling $84.9 million[73]. - As of September 30, 2024, the company had cash and cash equivalents of $84.9 million, down from $98.0 million as of December 31, 2023, with an accumulated deficit of $372.1 million[87]. - No changes in internal control over financial reporting occurred during the three months ended September 30, 2024, that materially affected internal control[94]. - The management evaluated the effectiveness of disclosure controls and procedures as of September 30, 2024, concluding they were effective at a reasonable assurance level[94].

Company Overview - SCYNEXIS, Inc. is a biotechnology company focused on developing innovative medicines to combat difficult-to-treat and drug-resistant infections [3] - The company is advancing its proprietary antifungal platform known as "fungerps" [3] - Ibrexafungerp, the first drug from this novel class, has been licensed to GSK and received FDA approval for vulvovaginal candidiasis in June 2021, with a second indication approved in November 2022 [3] Upcoming Event - David Angulo, M.D., President and CEO of SCYNEXIS, will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on October 17, 2024, at 11:30 A.M. ET [1] - The event will be held virtually, and investors can sign up to view the presentation [1] Clinical Development - Late-stage clinical investigations of ibrexafungerp for treating life-threatening invasive fungal infections in hospitalized patients are currently ongoing [3] - Additional antifungal compounds from the same class, including SCY-247, are in pre-clinical and discovery phases [3]

JERSEY CITY, N.J., Oct. 03, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drugresistant infections, today announced upcoming presentations of preclinical efficacy and pharmacokinetic data on its second-generation fungerp candidate SCY-247 at IDWeek 2024 taking place in Los Angeles, CA from October 16-19, 2024. Presentation details can be found below: Oral Presentation: | --- | --- | |------------ ...

JERSEY CITY, N.J., Aug. 27, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drugresistant infections, today announced David Angulo, M.D., President and Chief Executive Officer, will make a corporate presentation as well as host 1x1 meetings at the H. C. Wainwright 26th Annual Global Investment Conference on Wednesday, September 11 at 10:00 A.M. ET. H. C. Wainwright 26th Annual Global Investment Con ...

Clinical study reports for the FURI, CARES and NATURE trials in refractory or resistant invasive fungal infections were delivered to GSK, triggering a $10 million development milestone payment to SCYNEXIS which we expect to receive in Q3 2024. SCY-247's IND-enabling activities continue to progress. Pre-clinical in vitro and in vivo studies, presented at several medical conferences, have shown potent and broad antifungal activity. Phase 1 study initiation is planned for Q4 2024. SCYNEXIS ended Q2 2024 with c ...

Results from the open-label studies of ibrexafungerp in patients with refractory or resistant fungal diseases (FURI) and in patients with Candidiasis caused by Candida auris (CARES) are positive and consistent with previously announced interim analyses and are expected to be presented at a future scientific meeting. NATURE was an observational study to evaluate the outcome of patients with invasive candidiasis treated with available standard of care options and was designed as an external control strategy f ...