Enanta Pharmaceuticals(ENTA) - 2025 Q2 - Quarterly Results

Executive Summary & Program Highlights Enanta Pharmaceuticals reported progress across its virology and immunology pipelines for the fiscal second quarter of 2025, meeting target enrollment for the Phase 2 RSVHR study of zelicapavir and maintaining a strong cash position bolstered by a significant federal income tax refund - Met target enrollment of 180 patients in RSVHR, a Phase 2 study of zelicapavir for high-risk adults with RSV, with topline data expected in late Q3 2025[2][5] - Plans to select a lead development candidate for the oral STAT6 inhibitor program in the second half of 2025, targeting atopic dermatitis initially[3][5] - IND-enabling studies are ongoing for EPS-1421, the lead candidate in the KIT inhibitor program for chronic spontaneous urticaria[3][5] - Cash and marketable securities totaled $193.4 million at quarter-end, strengthened by a $33.8 million federal tax refund received in April 2025[5][12] Fiscal Second Quarter 2025 Financial Results Enanta reported total revenue of $14.9 million and a net loss of $22.6 million for Q2 FY2025, an improvement from the prior year due to reduced operating expenses, maintaining a strong cash position expected to fund operations into fiscal 2028 Q2 FY2025 vs Q2 FY2024 Financial Summary | Financial Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $14.9 million | $17.1 million | -12.9% | | R&D Expenses | $28.1 million | $35.6 million | -21.1% | | G&A Expenses | $11.4 million | $14.2 million | -19.7% | | Net Loss | ($22.6 million) | ($31.2 million) | +27.6% (Loss narrowed) | | Net Loss per Share | ($1.06) | ($1.47) | +27.9% (Loss narrowed) | - Revenue consists of royalties from AbbVie's HCV regimen MAVYRET®/MAVIRET®, with 54.5% of this royalty servicing debt from a $200.0 million royalty sale transaction with OMERS[4][6] - The decrease in R&D expenses was primarily due to the timing of clinical trials in the RSV program[7] - The decrease in G&A expenses was mainly due to lower legal costs related to the patent infringement lawsuit against Pfizer[8] - Cash, cash equivalents, and marketable securities totaled $193.4 million, with a subsequent $33.8 million tax refund, the company expects to fund operations into fiscal 2028[12] Pipeline and Program Updates Enanta is advancing a dual-focused pipeline in virology and immunology, with two Phase 2 RSV candidates exploring partnership opportunities and immunology programs progressing towards lead candidate selection and IND-enabling studies Virology Enanta's virology efforts focus on its leading RSV portfolio, featuring two oral antiviral candidates, zelicapavir and EDP-323, both with Fast Track designation, for which the company is evaluating potential partnerships - Zelicapavir (N-protein inhibitor): Met target enrollment of 180 high-risk adult patients in the Phase 2b RSVHR study, with topline data expected late in Q3 2025[16] - EDP-323 (L-protein inhibitor): Demonstrated highly statistically significant reductions in viral load and clinical symptoms in a human challenge study, usable as monotherapy or in combination[16] - Both zelicapavir and EDP-323 have received Fast Track designation from the U.S. FDA[16] - The company will evaluate potential partnership opportunities to further develop its RSV assets[14] Immunology The immunology pipeline focuses on oral inhibitors for inflammatory diseases, with the lead KIT inhibitor EPS-1421 in IND-enabling studies and a STAT6 inhibitor program poised to select a development candidate in late 2025, alongside plans for a third program - KIT Inhibitors: The lead candidate, EPS-1421, is a potent and selective oral inhibitor of KIT, currently undergoing scale-up activities and IND-enabling studies[16] - STAT6 Inhibitors: The program targets the transcription factor for IL-4/IL-13 signaling, with prototypes showing nanomolar inhibition, high selectivity, and in vivo target engagement, and a development candidate selection planned for 2H 2025[16][20] - Enanta plans to expand its immunology pipeline by introducing a third program in 2025[20] Corporate Updates Enanta received a $33.8 million federal income tax refund in April 2025 and is proceeding with its patent infringement lawsuit against Pfizer regarding Paxlovid™, having filed an opening brief in March 2025 - Received a $33.8 million federal income tax refund in April 2025[20] - Filed an opening brief with the U.S. Court of Appeals on March 21, 2025, in its patent infringement lawsuit against Pfizer concerning the COVID-19 antiviral, Paxlovid™[20] - The company plans to issue its fiscal third quarter 2025 financial results on August 11, 2025[20] Financial Statements The unaudited condensed consolidated financial statements provide a comprehensive view of Enanta's financial position as of March 31, 2025, and its operational results for the three and six months then ended, detailing revenues, expenses, assets, liabilities, and stockholders' equity Condensed Consolidated Statements of Operations For the three months ended March 31, 2025, Enanta reported revenues of $14.9 million and a net loss of $22.6 million, with both periods showing narrower losses compared to the prior year due to reduced operating expenses Condensed Consolidated Statements of Operations (Unaudited, in thousands) | | Three Months Ended March 31, | Six Months Ended March 31, | | :--- | :--- | :--- | :--- | | | 2025 | 2024 | 2025 | 2024 | | Revenue | $14,926 | $17,054 | $31,885 | $35,057 | | Total operating expenses | $39,453 | $49,820 | $79,955 | $102,709 | | Loss from operations | ($24,527) | ($32,766) | ($48,070) | ($67,652) | | Net loss | ($22,644) | ($31,157) | ($44,934) | ($64,564) | | Net loss per share, diluted | ($1.06) | ($1.47) | ($2.11) | ($3.06) | Condensed Consolidated Balance Sheets As of March 31, 2025, Enanta reported total assets of $323.0 million, including $193.4 million in cash and marketable securities, with total liabilities of $229.5 million and total stockholders' equity of $93.5 million Condensed Consolidated Balance Sheet Highlights (Unaudited, in thousands) | | March 31, 2025 | September 30, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and marketable securities | $193,375 | $248,186 | | Total current assets | $242,860 | $299,852 | | Total assets | $322,993 | $376,652 | | Liabilities and Equity | | | | Liability related to sale of future royalties (Total) | $156,060 | $169,241 | | Total liabilities | $229,455 | $247,838 | | Total stockholders' equity | $93,538 | $128,814 |