Core Insights - SCYNEXIS, Inc. is presenting data on its second-generation fungerp drug candidate, SCY-247, at the inaugural Interdisciplinary Meeting on Antimicrobial Resistance and Innovation (IMARI) from January 28 to 30, 2026, in Las Vegas, Nevada [1][2] - The company emphasizes the potential of SCY-247 as a critical weapon against drug-resistant fungal infections, highlighting its potent antifungal activity and favorable safety profile observed in clinical investigations [2][4] - IMARI is a joint conference organized by the American Society for Microbiology and the Infectious Diseases Society of America, focusing on the challenge of antimicrobial resistance [3] Company Overview - SCYNEXIS, Inc. is a biotechnology company focused on developing innovative medicines to combat difficult-to-treat infections, particularly those that are increasingly drug-resistant [4] - The company’s antifungal platform, "fungerps," includes Ibrexafungerp, which has been approved by the FDA for treating vulvovaginal candidiasis and reducing recurrent cases [4] - SCY-247 is currently in clinical development and has received QIDP and Fast Track designations from the FDA, with additional antifungal assets in pre-clinical and discovery phases [4]

Core Viewpoint - The FDA has granted SCYNEXIS, Inc. Qualified Infectious Disease Product (QIDP) and Fast Track Designations for its antifungal therapy SCY-247, which is aimed at addressing the urgent need for effective treatments against multi-drug resistant fungal infections like Candida auris [1][2]. Group 1: Company Developments - SCYNEXIS is developing SCY-247, a second-generation triterpenoid antifungal therapy, which is expected to receive at least 10 years of market exclusivity following FDA approval [1]. - The company plans to initiate a Phase 1 study of SCY-247 with an intravenous formulation and a Phase 2 study with an oral formulation in invasive candidiasis (IC) in 2026 [2]. - Positive Phase 1 data has shown SCY-247's promising safety and pharmacokinetic properties, achieving target exposures for invasive fungal disease at lower doses than the first-generation drug [2]. Group 2: Industry Context - There is a growing public health threat from multi-drug resistant fungal pathogens, particularly Candida auris, which is spreading globally and poses significant risks to individuals with compromised immune systems [3][4]. - The need for novel antifungal solutions is underscored by recent publications highlighting the virulence and resistance of Candida auris to existing antifungal therapies [3][4]. Group 3: Regulatory Insights - The QIDP designation requires the demonstration that the drug is intended to treat serious or life-threatening infections, providing a 5-year extension to any exclusivity upon approval [5]. - Fast Track designation allows for more frequent communication with the FDA, eligibility for Accelerated Approval and Priority Review, and the possibility of a Rolling Review process for the drug application [6].

Core Insights - SCYNEXIS, Inc. reported significant achievements that position the company for growth, including positive data for its second-generation drug candidate SCY-247 and a resolution of a disagreement with GSK resulting in a one-time payment of $24.8 million [2][3][5] Financial Performance - For Q3 2025, SCYNEXIS reported revenue of $0.3 million, a decrease from $0.7 million in Q3 2024, primarily from license agreement revenue associated with GSK [8] - Research and development expenses decreased to $5.5 million in Q3 2025 from $8.1 million in Q3 2024, a reduction of 33% driven by various cost decreases [9] - Selling, general and administrative expenses increased to $3.3 million in Q3 2025 from $2.9 million in Q3 2024, an increase of 13% primarily due to higher professional fees [10] - The net loss for Q3 2025 was $8.6 million, or $(0.17) per share, compared to a net loss of $2.8 million, or $(0.06) per share in Q3 2024 [12][20] Cash Position - As of September 30, 2025, SCYNEXIS had cash, cash equivalents, and investments totaling $37.9 million, down from $75.1 million at the end of 2024 [13] - The company expects to receive a one-time payment of $24.8 million from GSK in Q4 2025, resulting in a cash runway of more than two years [5][13] Drug Development Updates - SCY-247, the second-generation triterpenoid antifungal, showed positive results in a Phase 1 SAD/MAD study, demonstrating good tolerability and achieving target exposures at lower doses than the first-generation drug [6][14] - The company plans to initiate a Phase 1 study with the intravenous formulation of SCY-247 in Q1 2026 and a Phase 2 study for invasive candidiasis, with proof-of-concept data expected in 2026 [6][7] Partnership with GSK - SCYNEXIS resolved a disagreement with GSK, leading to a one-time payment of $24.8 million and the termination of the Phase 3 MARIO study on invasive candidiasis [3][5] - GSK is committed to relaunching BREXAFEMME® (ibrexafungerp), with SCYNEXIS set to receive up to approximately $146 million in annual net sales milestones and low to mid-single-digit royalties [5][15]

Core Insights - SCYNEXIS, Inc. announced positive results from a Phase 1 study of SCY-247, a second-generation triterpenoid antifungal aimed at treating and preventing invasive fungal infections, showing potential for both oral and IV formulations [1][2] Phase 1 Study Overview - The Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of SCY-247 in healthy participants, with single ascending doses (SAD) ranging from 50mg to 900mg and multiple ascending doses (MAD) from 50mg to 300mg, administered once daily for 7 days [3] - A total of 66 participants received SCY-247 and 22 received a placebo across the SAD and MAD cohorts [3] Phase 1 Study Results - SCY-247 was well tolerated, with no serious or severe treatment-emergent adverse events (TEAEs) reported, and the incidence of TEAEs was low and not dose-dependent [4] - The most common adverse events included mild to moderate headache in 16.7% of SCY-247 participants and diarrhea in 9% of both SCY-247 and placebo participants [4] Pharmacokinetics and Efficacy - SCY-247 demonstrated generally dose-proportional pharmacokinetics, with rapid absorption (Tmax ranging from 3 to 7 hours) and increased systemic exposure (Cmax and AUC) with dose [5] - The MAD cohorts of 200mg and 300mg achieved or exceeded the preliminary target for efficacious exposure based on pre-clinical models, including resistant strains like Candida auris and echinocandin-resistant Candida glabrata [5] Company Background - SCYNEXIS is a biotechnology company focused on developing innovative antifungal medicines to address drug-resistant infections, with its first product, Ibrexafungerp, already approved for vulvovaginal candidiasis [6][8] - The company is advancing its proprietary antifungal platform "fungerps" and has ongoing late-stage clinical investigations for Ibrexafungerp in life-threatening invasive fungal infections [6]

Core Insights - SCYNEXIS, Inc. is set to present data on its second-generation antifungal drug candidate SCY-247 at the TIMM-12 Congress, highlighting its potential against drug-resistant Candida infections, particularly C. auris [1][2] Company Overview - SCYNEXIS, Inc. is a biotechnology company focused on developing innovative medicines to combat difficult-to-treat infections that are increasingly drug-resistant [7] - The company has developed a proprietary antifungal platform called "fungerps," with its first product, Ibrexafungerp, already approved for certain indications [8] Upcoming Presentations - The company will have six presentations at TIMM-12, showcasing SCY-247's efficacy against resistant Candida infections [2] - Key presentations include: - In vitro activity against C. auris, including strains with echinocandin-resistance mutations [3] - Uniform activity against various Candida species with no cross-resistance to echinocandins [5] - Efficacy in a murine model of C. auris infection, demonstrating significant reductions in fungal burden [6] Clinical Trials - SCYNEXIS anticipates reporting results from its Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) trial for SCY-247 in Q3 2025, marking a significant step in the drug's development [4][9]

Core Insights - SCYNEXIS, Inc. reported financial results for Q2 2025, highlighting progress in its drug development pipeline and ongoing disputes with GSK regarding milestone payments [1][5][9]. Drug Development Progress - The company is advancing its second-generation fungicide candidate, SCY-247, with Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) data expected to be announced in Q3 2025 [2][7]. - Positive preclinical efficacy data for SCY-247 was presented at the ESCMID meeting, showcasing its potential against difficult-to-treat fungal infections [4]. - The first new patient was dosed in the Phase 3 MARIO study after the FDA lifted the clinical hold, triggering a $10 million milestone payment from GSK [5][6]. Financial Performance - For Q2 2025, SCYNEXIS reported revenue of $1.4 million, up from $0.7 million in Q2 2024, primarily from the GSK License Agreement [9]. - Research and development expenses increased to $7.1 million in Q2 2025 from $6.8 million in Q2 2024, driven by higher costs in chemistry, manufacturing, and controls [10]. - Selling, general, and administrative expenses rose to $3.8 million in Q2 2025, a 20% increase from $3.2 million in Q2 2024, mainly due to higher professional fees [11]. - The net loss for Q2 2025 was $6.9 million, or $(0.14) per share, compared to a net loss of $14.5 million, or $(0.30) per share in Q2 2024 [13]. Cash Position - As of June 30, 2025, the company had cash, cash equivalents, and investments totaling $46.5 million, down from $75.1 million at the end of 2024, providing a cash runway into Q4 2026 [14]. Legal Developments - The U.S. District Court granted SCYNEXIS's motion to dismiss a securities class action lawsuit filed in November 2023, allowing the plaintiff to amend the complaint within 30 days [8]. Corporate Strategy - SCYNEXIS is working to transfer the New Drug Application for Brexafemme to GSK by the end of 2025, enabling GSK to initiate regulatory discussions for the product's relaunch [6][16].

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].