Enanta Pharma (NASDAQ: ENTA) reported Q4 EPS of $0.44, $0.09 worse than the analyst estimate of $0.53. Revenue for the quarter came in at $51.3 million versus the consensus estimate of $55.94 million.

• Initiation of RSVP, a Phase 2b study of EDP-938 in adult outpatients with RSV
• EDP-297 selected as follow-on FXR agonist with differentiated preclinical profile
• Royalty revenue for the quarter was $51.3 million
• Cash and marketable securities totaled approximately $400 million at September 30, 2019

“During 2019, we successfully advanced our lead RSV, NASH and HBV compounds in clinical trials,” commented Jay R. Luly, Ph.D., Enanta President and CEO. “EDP-938, the only RSV N-protein inhibitor in clinical development today, has shown highly statistically significant reductions in RSV viral load and total symptom score endpoints in a human challenge study, and we have initiated RSVP, our first Phase 2b study, which is in adult outpatients with community-acquired RSV. Following RSVP, we are planning additional studies in other patients such as the elderly, immune-compromised patients and pediatric populations. In NASH, we plan to further evaluate EDP-305 in a Phase 2b study, known as ARGON-2, in biopsy-proven NASH patients. This study will include an interim readout to enhance our ability to seek opportunities more quickly for development of EDP-305 in combinations with other mechanisms in NASH. Additionally, in NASH, Enanta has selected EDP-297 as its follow-on FXR development candidate. Preclinical data on EDP-297 reveal a differentiated profile that delivers high target-tissue distribution along with potency greater than that published on any FXR agonist in clinical development today. Finally, our Phase 1a study of EDP-514, our lead core inhibitor candidate for treatment of chronic HBV , is on track to have topline data from healthy volunteers in the first quarter of calendar 2020, after which we plan to proceed to study EDP-514 in ‘nuc-suppressed’ HBV patients and viremic HBV patients in the first and second quarters, respectively.”

Financial Guidance for Fiscal Year 2020

• Research and Development Expense: $155 million to $175 million
• General and Administrative Expense: $27 million to $33 million

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