Enanta Pharmaceuticals Reports Fiscal Fourth Quarter and Full-Year 2025 Financial Results and Highlights Major Clinical Advancements Across Virology and Immunology Programs
Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company developing differentiated small-molecule medicines for viral infections and immunological disorders, announced its financial results for the fiscal fourth quarter and year ended September 30, 2025. Alongside the financial update, the Company provided a detailed overview of its expanding pipeline, including new clinical data across its respiratory syncytial virus (RSV) portfolio and significant progress within its emerging immunology franchise.
Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals, emphasized the transformational nature of the quarter. “This past quarter marked a pivotal period for Enanta Pharmaceuticals, with significant progress across our virology and immunology programs, highlighted by positive topline data from the RSVHR study, our Phase 2b clinical trial in high-risk adults infected with RSV,” Luly stated. “These Phase 3-enabling results underscore zelicapavir’s ability to meaningfully reduce the duration of RSV symptoms and represent the first time an antiviral treatment demonstrated a clinically meaningful benefit in high-risk adult outpatients with RSV.”
Dr. Luly further noted major advancements in the Company’s immunology pipeline, including the nomination of EPS-3903 as its lead oral STAT6 inhibitor for type 2 immune-driven diseases and EDP-978 as its oral small-molecule KIT inhibitor for mast cell-driven conditions. “Taken together, these milestones strengthen our position as a leader in the development of small-molecule approaches for immunological diseases,” he added.
Financial Results for Fiscal Fourth Quarter and Fiscal Year Ended September 30, 2025
Revenue
For the quarter ended September 30, 2025, Enanta Pharmaceuticals generated total revenue of $15.1 million, up from $14.6 million in the same period last year. Revenue continues to be derived primarily from royalties on AbbVie’s hepatitis C virus (HCV) therapy, MAVYRET®/MAVIRET®. The increase reflects higher net global sales of the therapy by AbbVie during the quarter.
For the full fiscal year, revenue totaled $65.3 million, down from $67.6 million in fiscal 2024. The year-over-year decline reflects lower MAVYRET®/MAVIRET® sales during the first three quarters of fiscal 2025.
Royalty Arrangement With OMERS
Enanta’s royalty revenues remain subject to a previously announced royalty monetization agreement with OMERS, one of Canada’s largest pension plans. Under this arrangement, 54.5% of Enanta’sPharmaceuticals royalties from MAVYRET®/MAVIRET® are payable to OMERS until June 30, 2032, or until OMERS receives 1.42× its original purchase amount of $200 million, whichever comes first.
Accounting treatment requires Enanta Pharmaceuticals to record 100% of the earned royalties as revenue, while recognizing the payment obligation to OMERS as amortization of a debt liability on its balance sheet.
Interest expense related to this liability totaled:
- $2.4 million for Q4 FY2025, compared with $2.6 million for Q4 FY2024
- $7.7 million for FY2025, compared with $10.9 million for FY2024
The decline reflects the scheduled amortization of the debt balance.
Operating Expenses
Research and Development (R&D)
R&D expenses for Q4 FY2025 were $23.8 million, down from $30.8 million in the prior-year quarter. The decrease was primarily driven by the timing of clinical trial activities in the Company’s RSV programs.
For FY2025 as a whole, R&D expenses were $106.7 million, compared with $131.5 million for FY2024, reflecting reduced RSV trial spending partially offset by growing investment in Enanta’s Pharmaceuticals immunology pipeline.
General and Administrative (G&A)
G&A expenses were $9.7 million for Q4 FY2025, down from $13.7 million a year earlier. Full-year G&A expenses were $43.9 million, compared with $57.9 million in fiscal 2024.
The year-over-year reduction was largely due to lower legal spending following progress in the Company’s patent litigation against Pfizer and a decline in stock-based compensation expense.
Interest and Investment Income
Interest and investment income totaled:
- $2.1 million for Q4 FY2025, versus $3.2 million in Q4 FY2024
- $9.5 million for FY2025, compared to $14.8 million in FY2024
This decrease primarily reflects lower average cash and marketable securities balances and lower interest yield on investments.
Income Taxes
Enanta Pharmaceuticals recorded an income tax expense of less than $0.1 million for Q4 FY2025, compared with an income tax benefit of $0.4 million in the prior-year quarter. For the full fiscal years 2024 and 2025, the Company recorded an income tax benefit of $1.7 million in each year.
During fiscal 2024 and 2025, Enanta Pharmaceuticals also earned interest on its federal income tax refund until the $33.8 million refund was received in April 2025.
Net loss improved significantly:
- Q4 FY2025 net loss was $18.7 million (or $0.87 per diluted share)
vs. $28.8 million (or $1.36 per diluted share) in Q4 FY2024. - FY2025 net loss was $81.9 million (or $3.84 per diluted share)
vs. $116.0 million (or $5.48 per diluted share) in FY2024.
The improvement was driven by reductions in operating expenses.
Cash Position and Financial Outlook
Enanta ended the fiscal year with $188.9 million in cash, cash equivalents, and marketable securities.
Management stated that the Company expects its existing cash, future retained royalty revenue, and proceeds from its October 2025 public offering to fund operations into fiscal 2029. This projected runway supports continued advancement of its virology and immunology programs, including IND-enabling work for multiple pipeline candidates.
Pipeline and Research Program Updates
Virology Programs
Enanta Pharmaceuticals continues to lead the field in the development of RSV antivirals, with two differentiated once-daily oral candidates—zelicapavir and EDP-323—both of which have received FDA Fast Track designation.
Zelicapavir — RSV N-Protein Inhibitor
In September, Enanta Pharmaceuticals announced positive topline results from RSVHR, a Phase 2b randomized, double-blind, placebo-controlled trial in high-risk adults with RSV. This population included older adults and those with chronic cardiopulmonary conditions.
Key findings included:
● 2.2-day reduction in time to complete resolution of all 13 RSV symptoms across the overall population
● 6.7-day improvement in the HR3 subgroup (patients ≥75 years or with CHF/COPD), which comprised 81% of participants
● 3.6-day improvement on the expanded 29-symptom RiiQ™ total symptom scale
● 7.2-day improvement in the HR3 subgroup
● 3-day faster resolution of lower respiratory tract disease symptoms (HR3 subgroup)
● Statistically significant improvement on the Patient Global Impression of Severity (PGI-S)
● Lower hospitalization rates vs. placebo
● Strong antiviral activity and a favorable safety profile
These results position zelicapavir for advancement into Phase 3 development.
Pediatric RSV Data
At IDWeek™ 2025, Enanta Pharmaceuticals also presented new pediatric data showing that zelicapavir:
- Shortened median time to complete symptom resolution to 6.99 days, compared with 8.60 days for placebo
- Reduced sustained resolution time (symptoms absent and remained absent) to 6.99 days, vs. 10.68 days for placebo
These data further validate zelicapavir’s potential across age groups.
EDP-323 — RSV L-Protein Inhibitor
EDP-323 is designed for use as monotherapy or in combination with zelicapavir to broaden therapeutic potential.
At IDWeek™ 2025, key findings from the human challenge study included:
- Post-exposure prophylaxis (PEP) benefit:
– 26% of placebo subjects became infected
– 0% of EDP-323 recipients became infected (p<0.001) - Both low-dose and high-dose arms independently demonstrated statistically significant reductions in infection rates
- Rapid and significant reductions in RiiQ™ symptom scores within 24 hours
- 73%, 61%, and 67% reductions in symptom score AUC for the 200 mg, 600 mg, and pooled groups, respectively
- Strong antiviral activity and symptom improvement
These results continue to support EDP-323’s potential as a preventive agent and therapeutic option.
Immunology Programs
Enanta is building a significant presence in immunology with a focus on next-generation oral small-molecule therapies targeting drivers of type 2 inflammation.
EPS-3903 — Oral STAT6 Inhibitor (Lead Immunology Candidate)
Enanta Pharmaceuticals announced the nomination of EPS-3903 as its lead STAT6 inhibitor candidate, intended for atopic dermatitis, asthma, and other diseases currently treated with biologics such as dupilumab.
Preclinical highlights include:
- Potent nanomolar activity and high selectivity for STAT6
- >90% inhibition of pSTAT6 in vivo with once-daily oral dosing
- Efficacy comparable to dupilumab across multiple animal models
- Strong biomarker reductions including eosinophils, TARC, and IgE
- Favorable ADME properties
Enanta plans to file an IND in the second half of 2026.
EDP-978 — Oral KIT Inhibitor
EDP-978 was selected as Enanta’s clinical candidate for mast-cell driven conditions such as chronic spontaneous urticaria.
Key data:
- Nanomolar potency; sub-nanomolar in vivo activity
- High selectivity for KIT versus other kinases
- Strong preclinical ADME properties
An IND filing is planned for Q1 2026.
Pipeline Expansion
Enanta Pharmaceuticals expects to introduce a third immunology program in Q4 2025 as it continues building a broad small-molecule immunology platform.
Corporate Updates
Patent Litigation Against Pfizer
In August, Enanta Pharmaceuticals filed a patent infringement suit in the European Union’s Unified Patent Court (UPC) alleging Pfizer’s COVID-19 therapy Paxlovid™ infringes European Patent No. EP 4 051 265. A hearing is expected within the UPC’s targeted 12-month review window.
In October, Enanta Pharmaceuticals closed an upsized underwritten public offering of 7,475,000 shares at $10.00/share, generating gross proceeds of $74.8 million.
Upcoming Milestones
Enanta plans to release its fiscal first-quarter 2026 financial results on February 9, 2026.
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