Enanta Pharmaceuticals(ENTA) - 2025 Q3 - Quarterly Results

Overview and Highlights Management Commentary and Key Achievements Enanta Pharmaceuticals reported steady pipeline progress in Q3 FY2025, completing zelicapavir's RSVHR trial enrollment and advancing immunology programs, backed by $204.1 million in cash - Completed enrollment in the RSVHR trial of zelicapavir, with topline data expected in September 2025[2][5] - Advancing immunology programs with IND-enabling studies for oral KIT inhibitor EPS-1421 and expecting to select a lead candidate for the oral STAT6 inhibitor program in H2 2025[2][5] - The company plans to announce a third immunology program later in 2025 to expand its inflammatory disease pipeline[2] - Operations are supported by cash and marketable securities totaling $204.1 million as of June 30, 2025, alongside ongoing retained royalties[5][11] Fiscal Third Quarter 2025 Financial Results Financial Performance Summary Enanta reported Q3 FY2025 total revenue of $18.3 million, a slight increase, with reduced R&D and G&A expenses leading to a narrowed net loss of $18.3 million Q3 FY2025 vs Q3 FY2024 Financial Performance (in millions, except per share data) | Metric | Q3 2025 | Q3 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $18.3 | $18.0 | +1.7% | | R&D Expenses | $27.2 | $28.7 | -5.2% | | G&A Expenses | $10.0 | $13.4 | -25.4% | | Net Loss | $(18.3) | $(22.7) | Narrowed | | Loss Per Share | $(0.85) | $(1.07) | Narrowed | - Revenue primarily consisted of royalties from worldwide net sales of AbbVie's HCV regimen MAVYRET®/MAVIRET®[3] - The decrease in R&D expenses was primarily due to the timing of clinical trials in the RSV programs[6] - The decrease in G&A expenses was mainly due to lower legal expenses related to the patent infringement lawsuit against Pfizer[7] Financial Position and Outlook As of June 30, 2025, Enanta held $204.1 million in cash and marketable securities, projected to fund operations into fiscal year 2028 with future royalties - Cash, cash equivalents, and short-term marketable securities totaled $204.1 million at June 30, 2025[11] - The company expects its current cash position and future royalties to be sufficient to meet anticipated cash requirements into fiscal year 2028[11] - The company received a federal income tax refund of $33.8 million in April 2025[9] Pipeline and Corporate Updates Virology Program Enanta's virology pipeline focuses on oral antiviral treatments for RSV, including zelicapavir and EDP-323, with key progress in clinical trials and partnership evaluations Zelicapavir (N-protein inhibitor) - Enrollment is complete with 186 patients in the RSVHR Phase 2b study in high-risk adults[12] - Topline data from the RSVHR study is on track to be reported in September 2025[12] - Positive Phase 2 data in pediatric patients were presented at the ESPID 2025 Conference, highlighting shortened time to viral load negativity[12][13] EDP-323 (L-protein inhibitor) - EDP-323 is a potent, oral RSV L-protein inhibitor, suitable for monotherapy or combination use with agents like zelicapavir[16] - New data from a Phase 2a study were presented at the ESCMID Global 2025 Conference, highlighting reduced respiratory mucus production[16] Immunology Program Enanta's immunology pipeline focuses on oral inhibitors for inflammatory diseases, with IND-enabling studies for EPS-1421 and a STAT6 inhibitor candidate selection planned for H2 2025 EPS-1421 (KIT inhibitor) - IND-enabling studies and scale-up activities are ongoing for EPS-1421, a novel oral KIT inhibitor[16] - EPS-1421 is being developed for chronic spontaneous urticaria and other mast cell-driven diseases[16] STAT6 Inhibitor Program - Enanta is on track to select a STAT6 inhibitor development candidate in H2 2025[16] - Preclinical data show prototype oral STAT6 inhibitors exhibit potent nanomolar activity and high selectivity[16] Pipeline Expansion - Enanta plans to expand its immunology pipeline by introducing a third program in 2025[16] Corporate Developments Corporate updates include AbbVie's FDA approval for an expanded MAVYRET® indication and Enanta's plan to issue Q4 and year-end results on November 17, 2025 - Partner AbbVie received FDA approval for an expanded indication for MAVYRET® to treat acute HCV[16] - Enanta plans to issue its fiscal fourth quarter and year-end financial results on November 17, 2025[16] Financial Statements Condensed Consolidated Statements of Operations The statement details financial performance for the three and nine months ended June 30, 2025, showing $18.3 million revenue and $18.3 million net loss for the quarter Condensed Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended June 30, | Nine Months Ended June 30, | | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Revenue | $18,314 | $17,971 | $50,199 | $53,028 | | Total operating expenses | $37,207 | $42,156 | $117,162 | $144,865 | | Loss from operations | $(18,893) | $(24,185) | $(66,963) | $(91,837) | | Net loss | $(18,255) | $(22,658) | $(63,189) | $(87,222) | | Net loss per share, Basic & Diluted | $(0.85) | $(1.07) | $(2.96) | $(4.12) | Condensed Consolidated Balance Sheets The balance sheet presents Enanta's financial position as of June 30, 2025, with total assets at $301.0 million and total stockholders' equity at $79.3 million Condensed Consolidated Balance Sheet Highlights (in thousands) | | June 30, 2025 | September 30, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents & marketable securities | $204,111 | $248,186 | | Total current assets | $222,708 | $299,852 | | Total assets | $301,029 | $376,652 | | Total current liabilities | $44,549 | $57,535 | | Total liabilities | $221,750 | $247,838 | | Total stockholders' equity | $79,279 | $128,814 |