Enanta Pharmaceuticals(ENTA) - 2025 Q3 - Quarterly Report

Financial Position - As of June 30, 2025, the company had $204.1 million in cash, cash equivalents, and short-term marketable securities, expected to fund operations into fiscal 2028[69]. - The company anticipates that existing cash, cash equivalents, and short-term marketable securities will fund operations into fiscal 2028[83]. - Cash used in operating activities decreased by $55.6 million (81.3%) to $12.8 million for the nine months ended June 30, 2025, compared to $68.4 million in 2024, primarily due to lower R&D payments and a $33.8 million tax refund[121]. Revenue and Sales - Revenue for the three months ended June 30, 2025, was $18.3 million, a slight increase of $0.3 million compared to $18.0 million in the same period in 2024, primarily due to higher reported HCV sales by AbbVie[96]. - Revenue for the nine months ended June 30, 2025, was $50.2 million, a decrease of $2.8 million (5.3%) compared to $53.0 million in the same period in 2024, primarily due to lower reported HCV sales[110]. - Total royalty revenue for the three months ended June 30, 2025, was $18.3 million, compared to $17.9 million for the same period in 2024[84]. - The company continues to record 100% of HCV royalties earned under the AbbVie agreement as royalty revenue in its financial statements[80]. - Ongoing royalty revenues from the AbbVie agreement consist of annually tiered, double-digit royalties on 50% of the calendar year net sales of the glecaprevir/pibrentasvir combination in MAVYRET/MAVIRET[78]. Research and Development - The company is developing two clinical stage candidates for RSV: zelicapavir and EDP-323, with zelicapavir showing a viral load decline of 1.4 log at Day 5 compared to placebo in pediatric studies[71]. - EDP-235, an oral inhibitor targeting SARS-CoV-2, demonstrated a two-day shorter time to improvement in patients receiving 400 mg compared to placebo[73]. - The company plans to expand its immunology presence with a third program in 2025, focusing on oral STAT6 inhibitors for type 2 immune-driven diseases[75]. - The company’s RSV programs are expected to advance through potential partnerships, with ongoing Phase 2b studies in high-risk adult populations[71]. - EDP-323 achieved statistically significant reductions in viral load and clinical symptoms in a Phase 2a study, with p=<0.0001 compared to placebo[74]. - The company’s research and development efforts are focused on small molecule drugs for virology and immunology indications, leveraging its chemistry-driven approach[63]. - The company is conducting a Phase 2b study of zelicapavir in high-risk adults, which completed enrollment in May 2025[81]. - The company has a preclinical program for oral KIT inhibitors targeting CSU, with lead candidate EPS-1421 selected for further development[75]. Expenses - Research and development expenses for the three months ended June 30, 2025, decreased by $1.5 million to $27.2 million from $28.7 million in the same period in 2024[100]. - Total research and development expenses decreased by $17.8 million (17.6%) to $82.9 million for the nine months ended June 30, 2025, compared to $100.7 million in 2024[111]. - Virology program costs decreased by $19.8 million (27.5%) primarily due to the timing of clinical trials in RSV programs[112]. - Immunology program costs increased by $6.2 million (37.9%) due to the initiation of preclinical studies for the STAT6 program[113]. - General and administrative expenses decreased by $9.9 million (22.4%) to $34.2 million for the nine months ended June 30, 2025, compared to $44.2 million in 2024[115]. - Interest expense decreased by $3.1 million (37.1%) to $5.3 million for the nine months ended June 30, 2025, compared to $8.4 million in 2024[116]. - Interest and investment income, net, decreased by $4.2 million (36.3%) to $7.4 million for the nine months ended June 30, 2025, compared to $11.6 million in 2024[117]. Losses - Net loss for the nine months ended June 30, 2025, was $63.2 million, an improvement of $24.0 million (27.5%) compared to a net loss of $87.2 million in 2024[109]. - The company has not generated any revenue from its own product sales and does not expect to do so for at least the next several years[86]. Market Insights - The estimated global prevalence of chronic spontaneous urticaria (CSU) is between 0.5% – 1%, affecting approximately 1.75-3.5 million people in the U.S. alone[67]. - The hospitalization burden of RSV is significant, with estimates of 3 million hospitalizations globally in children under 5 years old and 177,000 in U.S. adults over 65[65].