SCYNEXIS Reports Third Quarter 2026 Financial Results and Provides Corporate Update

(NASDAQ: SCYX) SCYNEXIS, Inc. reported financial results for the third quarter ended September 30, 2026, and provided a corporate update. The company completed a Phase 1 study of SCY-770, a selective and direct AMPK activator, enrolling 25 healthy participants across three cohorts with dosing regimens of 500 mg single dose, 750 mg once daily, or 500 mg twice daily, or placebo for seven days. SCY-770 was well tolerated at higher doses than previously evaluated, and pharmacokinetic and safety data will inform dose selection for the planned Phase 2 trial in Autosomal Dominant Polycystic Kidney Disease (ADPKD). SCYNEXIS plans to initiate the Phase 2 proof-of-concept study of SCY-770 in ADPKD patients in Q4 2026, with an interim analysis anticipated in Q4 2027. The company was awarded a BARDA contract providing up to approximately $214 million in non-dilutive funding, with $18.5 million in the initial base period, to advance the development of SCY-247 for invasive candidiasis. The BARDA award is structured as a cost-share arrangement, and SCYNEXIS expects to fund its share of near-term program costs for SCY-247 within its existing operating plan. On October 22, 2026, SCYNEXIS announced topline results from its Phase 1 single and multiple ascending dose trial of intravenous SCY-247 in 56 healthy participants, showing that IV SCY-247 was generally well tolerated, with no drug-related serious adverse events, and once-daily IV doses of 50 mg or higher achieved exposures at or above the efficacy target identified in murine models. The company expects to initiate Phase 2 development of SCY-247 in oral and IV formulations in 2027, subject to regulatory agreement. SCYNEXIS believes GSK continues making progress toward the relaunch of BREXAFEMME, and following the relaunch, SCYNEXIS has the potential to receive up to approximately $146 million in annual net sales milestones as well as net royalties in the low to mid-single digit range. Leadership changes include the appointment of Sanjay S. Subramanian, MBA, as Chief Financial Officer effective September 9, 2026, succeeding Ivor Macleod, and Todd Minga, M.D., as Senior Vice President, Research & Development effective September 14, 2026. Steven K. Burke, M.D., was appointed to the Board of Directors effective September 18, 2026, and serves on the Nominating and Corporate Governance Committee. Research and development expenses for the three months ended September 30, 2026, were $6.2 million compared to $5.5 million for the same period in 2025, an increase of $0.7 million or 14%, primarily driven by a $1.7 million increase in clinical expense, offset by a $0.6 million decrease in preclinical expense and a $0.4 million decrease in chemistry, manufacturing, and controls expense. SG&A expenses for the three months ended September 30, 2026, increased to $3.6 million compared to $3.3 million for the same period in 2025, an increase of $0.3 million or 8%, primarily due to a $0.2 million increase in professional fees. Total other income was $1.3 million for the three months ended September 30, 2026, versus total other expense of $0.2 million for the same period in 2025, mainly due to other income recognized for certain research and development tax credits. Cash, cash equivalents and investments totaled $63.2 million on September 30, 2026, compared to $71.1 million on June 30, 2026, with the decrease primarily due to continued development costs for SCY-770 and SCY-247. This cash position is expected to be sufficient to continue operations into 2029. ADPKD affects about 140,000 people in the United States, with approximately 6,000 new cases diagnosed each year, and more than 50% of patients reach end-stage renal failure by age 60. Jynarque (tolvaptan), the only approved therapy for ADPKD, achieved approximately $1.5 billion in U.S. sales in 2024. SCY-770 has been evaluated in approximately 300 participants to date and has been granted Orphan Drug Designation by the U.S. FDA. SCY-247 has been granted Orphan Drug, Qualified Infectious Disease Product (QIDP), and Fast Track designations by the U.S. FDA. The BARDA contract for SCY-247 is under contract number 75A50126C00007.

SCYNEXIS Completes Phase 1 Study of Intravenous SCY-247, a Novel, Triterpenoid Antifungal in Development for Treatment and Prevention of Invasive Fungal Diseases

(NASDAQ: SCYX) SCYNEXIS, Inc. announced topline results from its Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) trial of the intravenous (IV) formulation of SCY-247, a second-generation triterpenoid (fungerp) antifungal candidate. SCY-247 is being developed in both oral and IV formulations for the treatment and prevention of invasive fungal infections, with activity against drug-resistant fungi. Todd Minga, M.D., SVP of Research and Development at SCYNEXIS, stated that with Phase 1 studies of both formulations now complete, the company can refine plans for the next stage of development. SCYNEXIS was recently awarded a BARDA contract (75A50126C00007) providing up to approximately $214 million in non-dilutive funding, if milestones are achieved, to advance SCY-247 development. The BARDA award is structured as a cost-share arrangement, with BARDA supporting eligible SCY-247 costs, and SCYNEXIS expects to fund its share of near-term program costs within its existing operating plan. The company’s previously communicated development plans for SCY-770, including initiation of a Phase 2 study in the fourth quarter of 2026 and a projected cash runway into 2029, remain unchanged. The Phase 1 study enrolled 56 healthy participants across seven cohorts: 42 received SCY-247 by peripheral IV infusion and 14 received placebo. Single ascending doses up to 300 mg and multiple ascending doses once daily for seven days up to 200 mg were evaluated. SCY-247 administered by peripheral IV infusion was generally well tolerated, with the most common adverse reactions being mild to moderate erythema and pain at the infusion site. There were no drug-related serious adverse events or discontinuations due to a related adverse event. IV doses of 50 mg once daily or higher achieved exposures at or above the efficacy target identified in murine models of invasive candidiasis (AUC 0–24 of 20 µg·h/mL). A previously completed Phase 1 study indicated that oral doses of 100 mg or higher are also anticipated to achieve the target exposure for efficacy. SCY-247 has demonstrated in vitro and in vivo activity against several challenging Candida strains, including Candida auris and most azole- and echinocandin-resistant strains. SCY-247 has been granted Orphan Drug, Qualified Infectious Disease Product (QIDP), and Fast Track designations by the U.S. Food and Drug Administration. Future activities for this project may be funded in whole or in part with federal funds from the U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), and BARDA under contract number 75A50126C00007. SCY-770 is being developed for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD) and has been granted Orphan Drug designation. SCYNEXIS’s proprietary antifungal platform includes BREXAFEMME® (ibrexafungerp tablets), which has been licensed to GSK, and SCY-247, currently in clinical development for invasive fungal diseases.

SCYNEXIS Reports First Quarter 2026 Financial Results and Provides Corporate Update

SCYNEXIS, Inc. (NASDAQ: SCYX) completed the acquisition of PXL-770 (now SCY-770) and plans to begin a Phase 2 proof-of-concept study in ADPKD patients in Q4 2026, with early efficacy results anticipated in the second half of 2027. The company completed a private placement with net proceeds of approximately $37.2 million, extending its cash runway to mid-2029. SCYNEXIS ended Q1 2026 with $72.4 million in cash, cash equivalents, and investments. Research and development expenses for Q1 2026 were $12.4 million, up from $5.1 million in Q1 2025, primarily due to the $8.0 million IPR&D expense for the SCY-770 acquisition. GSK is committed to the relaunch of Brexafemme, which could provide up to approximately $146 million in annual net sales milestones.

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