Enanta Pharmaceuticals Delivers Key Updates on Virology and Immunology Programs While Reporting Fiscal Year 2024 Results
Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company specializing in small molecule drugs for virology and immunology, announced its financial results for the fiscal year and fourth quarter ending September 30, 2024. The company also shared significant progress across its research programs, including advancements in RSV treatments and the expansion of its immunology portfolio.
Key Developments in Virology
Enanta is advancing its RSV (respiratory syncytial virus) program with two clinical candidates, each targeting distinct mechanisms of action. Zelicapavir, an oral N-protein inhibitor, is undergoing Phase 2 trials in pediatric and adult populations. The RSVPEDs study, focusing on infants and young children, is set to deliver topline results in December 2024. Meanwhile, the RSVHR trial for high-risk adults continues its enrollment during the Northern Hemisphere RSV season.
Complementing zelicapavir, EDP-323, Enanta’s L-protein inhibitor, recently achieved positive results in a Phase 2a human challenge study. The drug demonstrated statistically significant reductions in viral load and clinical symptoms, solidifying its potential as a leading treatment for RSV. Both candidates hold FDA Fast Track designation, underscoring their promise in addressing this widespread infection.
Expanding the Immunology Portfolio
Enanta has broadened its focus to include treatments for type 2 immune-driven diseases, introducing two key programs:
- EPS-1421 – A KIT Inhibitor: This novel, potent, and selective oral molecule targets mast cells, a primary driver of chronic spontaneous urticaria and related diseases. With promising preclinical results, EPS-1421 is moving towards IND-enabling studies in 2025.
- STAT6 Inhibitors: These compounds are designed to block the IL-4/IL-13 signaling pathway, addressing conditions like atopic dermatitis and asthma. Currently in the discovery phase, the program aims to optimize lead candidates by 2025.
Leadership Commentary
“Our fourth quarter brought exciting milestones, including positive EDP-323 data and the near completion of our RSVPEDs study,” said Dr. Jay R. Luly, President and CEO of Enanta Pharmaceuticals. “With two differentiated RSV candidates and new initiatives in immunology, we are advancing our pipeline to deliver first-in-class and best-in-disease treatments for patients while creating value for shareholders.”
Dr. Luly also emphasized the strategic focus on developing targeted, small molecule therapies in virology and immunology, supported by a robust research framework.
Financial Performance
For the quarter ending September 30, 2024, Enanta reported total revenue of $14.6 million, a decline from $18.9 million in the same period last year, primarily due to reduced royalties from AbbVie’s hepatitis C therapy MAVYRET®/MAVIRET®. Full-year revenue decreased to $67.6 million from $79.2 million in 2023, reflecting the same trend.
Operating expenses also decreased, with research and development (R&D) costs at $30.8 million for the quarter, down from $36.2 million in 2023, driven by reduced investment in COVID-19-related programs. General and administrative (G&A) expenses remained stable at $13.7 million for the quarter but rose slightly year-over-year due to higher legal expenses linked to a patent lawsuit against Pfizer.
Enanta ended the fiscal year with a net loss of $116 million ($5.48 per diluted share), compared to $133.8 million ($6.38 per diluted share) in 2023. Cash, cash equivalents, and marketable securities totaled $248.2 million as of September 30, 2024, providing financial runway into fiscal 2027.
Corporate Outlook
Enanta’s strategic priorities include advancing RSV candidates, scaling its immunology programs, and leveraging retained royalties from AbbVie’s HCV sales to support operations. The company’s next significant milestone is the release of RSVPEDs study results in December 2024.
About Enanta Pharmaceuticals
Enanta leverages its expertise in small molecule drug discovery to tackle complex diseases in virology and immunology. Its portfolio includes leading RSV candidates and emerging programs in KIT and STAT6 inhibition for inflammatory diseases.
For more details, visit www.enanta.com.
