Enanta Pharmaceuticals, Inc. Q2 FY2023 earnings call

• Announced top line data from Phase 2 SPRINT study of EDP-235, a 3CL protease inhibitor for COVID-19. EDP-235 met primary endpoint with favorable safety/tolerability and dose-dependent symptom improvement.
• Low frequency of adverse events, no serious events or discontinuations. EDP-235 achieved target exposures with plasma levels above Omicron EC90.
• Discussed efficacy data showing dose-dependent total symptom score improvement, especially in patients within 3 days of symptom onset.
• Mentioned ongoing RSV programs: EDP-938 in Phase 2, EDP-323 in Phase 1 with data expected next month.
• Announced $200 million royalty sale transaction with OMERS for increased financial flexibility.

No traditional product segment performance reported as the focus is on EDP-235 and virology programs

• Current cash, cash equivalents, marketable securities, and $200 million from royalty sale sufficient to meet cash requirements into calendar 2026.
• Retained royalty revenue and $200 million will support existing business and development programs through 2026.

• Uncertainties in research, development, and financial projections due to assumptions and risks beyond control.
• Risks related to clinical trial outcomes, regulatory approvals, and market acceptance of products.

Q: Yasmeen Rahimi asks about next steps with SPRINT data and potential partner discussions.

A: Jay and Scott discuss progressing data with agency, focusing on symptom endpoints.

Q: Brian Abrahams asks about go-forward dose and TSS.

A: Jay and Scott discuss confidence in 400-milligram dose and dose-dependent efficacy.

Q: Brian Abrahams asks about TSS symptom signals without viral load effect.

A: Scott explains potential other reservoirs and tissue distribution.

Q: Brian Abrahams asks about triglyceride and cholesterol effects.

A: Scott says effects are mild and manageable, returning to baseline within 14 days.

Q: Roy Buchanan asks about DDI studies and EDP-514.

A: Jay discusses DDI profile and open-mindedness to combining assets.

Q: Unidentified Analyst asks about differences between Enanta's Phase 2 and prior COVID antivirals.

A: Jay and Tara discuss higher seropositivity in Enanta's population leading to more rapid viral load decline in placebo.

Q: Liisa Bayko asks about importance of RNA change in partnering and next steps for 323.

A: Jay discusses symptom importance and next steps for 323 Phase 1 data.

Q: Brian Skorney asks about TSS and time to improvement.

A: Jay explains that time to improvement is based on all 14 symptoms, with selected symptoms showing significance.

Q: Thomas Yip asks about COVID market opportunity and long COVID.

A: Tara discusses market size and long COVID being a different patient population.

Q: Thomas Yip asks about next steps for EDP-323.

A: Jay discusses Phase 1 data and potential challenge study.

Q: Roanna Ruiz asks about time to approval for EDP-235 and cholesterol/triglyceride trends.

A: Jay discusses partner impact on approval timeline and no specific patterns in elevated lipids.

Q: Hannah Adeoye asks about target patient population for EDP-235 and Pfizer's next-gen COVID antiviral.

A: Jay discusses broad patient populations and favorable market space.