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 Viewpoint - SCYNEXIS, Inc. has received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement for its common stock, allowing until June 15, 2026, to maintain a closing bid price of at least $1.00 per share for ten consecutive business days [1][2]. Company Overview - SCYNEXIS, Inc. is a biotechnology company focused on developing innovative medicines to combat difficult-to-treat and drug-resistant infections [4]. - The company is advancing its proprietary antifungal platform "fungerps," with Ibrexafungerp being the first representative licensed to GSK [4]. - The FDA has approved BREXAFEMME® (ibrexafungerp tablets) for treating vulvovaginal candidiasis (VVC) and reducing recurrent VVC incidence [4]. Strategic Objectives - The company plans to leverage its balance sheet to complete a Phase 1 study of an intravenous formulation for SCY-247 and generate proof-of-concept Phase 2 data for its oral formulation targeting invasive candidiasis infections [3]. - SCY-247 is anticipated to provide benefits for both hospitalized and community patients facing challenging infections, and it is highly regarded within the anti-infective scientific community [3]. Compliance Commitment - SCYNEXIS is committed to regaining compliance with all Nasdaq listing requirements and intends to take necessary actions within the 180-day extension period, including a potential reverse stock split if needed [2][3].

Core Insights - SCYNEXIS has successfully transferred the New Drug Application (NDA) for BREXAFEMME to GSK, enabling GSK to initiate regulatory discussions with the FDA for the relaunch of the drug targeting vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC) in the U.S. market [1][2] - Following the relaunch, SCYNEXIS is set to receive up to $145.5 million in annual net sales milestones and royalties in the low to mid single-digit range, providing a significant source of non-dilutive capital for the company [1][2] Company Overview - SCYNEXIS, Inc. is a biotechnology company focused on developing innovative medicines to combat difficult-to-treat and drug-resistant infections, with a proprietary antifungal platform known as "fungerps" [3] - Ibrexafungerp, the first drug from this novel class, has been approved by the FDA for the treatment of VVC and for reducing the incidence of recurrent VVC [3] - The company is also advancing additional antifungal assets, including the compound SCY-247, which are in various stages of clinical and pre-clinical development [3]

Core Insights - SCYNEXIS, Inc. announced the funding of a novel series of antifungal compounds through a federal grant awarded to a new accelerator consortium, which aims to develop therapeutics for drug-resistant fungal infections [1][2] Group 1: Funding and Collaboration - A five-year federal grant will establish a Center of Excellence in Translational Research (CETR) with an expected annual funding of approximately $7 million, contingent on available funds from the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) [1][2] - The collaboration includes researchers from Hackensack Meridian Center for Discovery and Innovation and the Johns Hopkins Bloomberg School of Public Health, focusing on the development of next-generation antifungal candidates [2][5] Group 2: Antifungal Development - Triterpenoid antifungals (fungerps) represent a new class of glucan synthase inhibitors aimed at addressing antimicrobial resistance in systemic fungal diseases, with the first compound, Ibrexafungerp, already approved by the FDA [3][5] - SCY-247, a second-generation fungerp, is currently in Phase 1 development and has shown broad-spectrum antifungal activity against multidrug-resistant pathogens [3][5] Group 3: Company Overview - SCYNEXIS is focused on developing innovative medicines to combat difficult-to-treat infections, particularly those that are drug-resistant, utilizing its proprietary antifungal platform [5][6] - The company aims to enhance the pharmacological properties of its next-generation fungerp candidates to effectively treat infections where current therapies are limited [5]

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]

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].

Core Insights - SCYNEXIS, Inc. announced a $22 million payment from GlaxoSmithKline (GSK) as part of resolving a disagreement regarding the Phase 3 MARIO study on invasive candidiasis [1][6] - The company will not receive additional milestone payments from GSK related to the MARIO study and will begin wind-down activities [1][6] - GSK remains committed to collaborating with SCYNEXIS on the commercialization of BREXAFEMME for vulvovaginal candidiasis (VVC) and refractory vulvovaginal candidiasis (rVVC) [2][6] Financial Implications - The $22 million payment, along with existing cash and the removal of future MARIO expenditures, extends SCYNEXIS's cash runway to over two years [6] - An additional payment of $2.3 million will be received by SCYNEXIS for the wind-down activities associated with the MARIO study [1] Product Development - SCYNEXIS is progressing the transfer of the BREXAFEMME New Drug Application (NDA) to GSK, expected to be completed by the end of 2025 [2] - GSK plans to initiate regulatory interactions with the U.S. FDA in 2026 to discuss the relaunch of BREXAFEMME for VVC and rVVC [2] - The company continues to develop SCY-247, a second-generation antifungal aimed at treating and preventing invasive fungal infections [3][4]

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]