ENANTA PHARMACEUTICALS INC Q1 FY2023 earnings call

• COVID-19 Program: Lead asset EDP-235 in Phase 2 SPRINT study completed enrollment beyond target, expects top-line data in May, plans Phase 3 trial in H2 if Phase 2 results support. Positive preclinical in vivo data in ferret model shows antiviral effect and transmission prevention. New research program on SARS-CoV-2 PLpro inhibitor.
• RSV Program: EDP-938 in multiple Phase 2 studies, EDP-323 in Phase 1 study in healthy subjects, expects top-line Phase 1 data next quarter. Respiratory discovery program targeting RSV and hMPV with dual inhibitor, aims to select clinical candidate in Q4 2023.
• Hepatitis B: Focused on identifying mechanisms and compounds to combine with EDP-514.
• Near-term Milestones: Announce SPRINT top-line data in May, report Phase 1 data for EDP-323 next quarter, present data at ICAR and ECCMID.

For the fiscal first quarter ended December 31, 2022, total revenue was $23.6 million, with $22.6 million coming from royalty revenue on AbbVie’s global MAVYRET net product sales. Research and development expenses totaled $40.9 million, down from $48.5 million in the same period of 2021. General and administrative expense was $12.7 million, up from $9.5 million in 2021. Net loss for the quarter was $29 million or $1.39 per diluted common share.

• Anticipate top-line data from SPRINT Phase 2 study in May and initiate Phase 3 trial for EDP-235 in H2 if Phase 2 results are favorable.
• Plan to report top-line Phase 1 data for EDP-323 in the next quarter.
• Aim to select a clinical candidate for the dual inhibitor targeting RSV and hMPV in Q4 2023.
• Current cash and royalty revenue expected to cover cash requirements into Q4 2024.

Q: What's the latest view on the COVID outlook and evolving market opportunity?

A: Jay Luly said COVID is migrating to endemic phase, sees it as a tremendous opportunity with potential avenues like high risk populations, standard risk, long COVID, and post-exposure prophylaxis.

Q: How cumbersome is the return of boost for Paxlovid and appetite for EDP-235 adoption?

A: Jay Luly mentioned ritonavir in Paxlovid adds complexity and drug-drug interactions, EDP-235 can be formulated as single tablet once daily with no boosting agent, which is attractive.

Q: For SPRINT trial, what is it powered to show and what are inflection points for partnering?

A: Primary endpoint is safety and tolerability, secondary endpoints gather info on symptoms, etc. Inflection points depend on data package building into something interesting and best in class.

Q: Thoughts on Pfizer's comments about competitor COVID antivirals?

A: Jay Luly said anything is possible, but EDP-235 has advantages of easier dosing and no boosting agent, so room for other convenient drugs.

Q: On EDP-323 in RSV, what criteria for judging early safety and PK study results?

A: Jay Luly said will look at safety, PK especially, aiming for once-daily dosing with adequate trough levels to pressure the virus.