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Financial Performance - For the year ended December 31, 2025, SCYNEXIS reported total revenue of $20.6 million, a significant increase from $3.7 million in 2024, primarily due to the GSK license agreement [8] - The company recognized a cumulative catch-up of $17.2 million in license agreement revenue associated with the Binding 2025 MOU with GSK [8] - Research and development expenses decreased to $22.3 million in 2025 from $26.4 million in 2024, a reduction of 15.6% [9] - Selling, general and administrative expenses slightly decreased to $14.4 million in 2025 from $14.5 million in 2024 [10] - The net loss for 2025 was $8.6 million, compared to a net loss of $21.3 million in 2024, indicating improved financial performance [18] Cash Position - As of December 31, 2025, SCYNEXIS had cash, cash equivalents, and investments totaling $56.3 million, down from $75.1 million in 2024 [12] - The company received a one-time non-refundable payment of $24.8 million from GSK in Q4 2025, extending its cash runway for more than two years [5][12] Product Development - SCYNEXIS is advancing its second-generation fungicide, SCY-247, with the first patient dosed in a Phase 1 study of the intravenous formulation, and topline data expected in the second half of 2026 [5][6] - The company plans to initiate an expanded access program for SCY-247 in the first half of 2026 to address patient needs for alternative antifungal therapies [5][6] - The FDA granted SCY-247 Qualified Infectious Disease Product (QIDP) and Fast Track Designations, which may facilitate its development and approval process [6] Strategic Partnerships - SCYNEXIS completed the transfer of the BREXAFEMME (ibrexafungerp) New Drug Application to GSK, which is committed to relaunching the product [6] - Following the relaunch of BREXAFEMME, SCYNEXIS could receive up to $145.5 million in annual net sales milestones and low to mid-single digit royalties [6] Research Initiatives - A novel series of antifungal compounds from SCYNEXIS' proprietary triterpenoid antifungal platform received funding through a federal grant, establishing a Center of Excellence in Translational Research [7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2025 OR ☐ 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 ...

Core Insights - SCYNEXIS, Inc. has initiated a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial for its intravenous formulation of SCY-247, an antifungal therapy aimed at treating invasive candidiasis and preventing invasive fungal diseases, with results expected in 2026 [1][2] Group 1: Company Developments - The first participants have been dosed in the Phase 1 trial of SCY-247, which has received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA, indicating its potential significance in treating severe fungal infections [2][3] - SCY-247's oral formulation has shown positive results in previous SAD/MAD data, demonstrating excellent pharmacokinetic and pharmacodynamic properties, achieving target exposures at lower doses than first-generation antifungals [2] - The company is exploring non-dilutive funding opportunities to support the SCY-247 program, highlighting its commitment to addressing health security threats posed by antifungal resistance [2] Group 2: Product Information - SCY-247 is part of SCYNEXIS's proprietary antifungal platform "fungerps," which includes Ibrexafungerp, already approved for treating vulvovaginal candidiasis [4] - The second-generation fungerp SCY-247 is currently in clinical development stages, with additional antifungal assets from this class in pre-clinical and discovery phases [4]

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]