Enanta Pharmaceuticals, Inc. Q3 FY2023 earnings call

• RSV Program: EDP-323 Phase 1 trial in healthy volunteers showed positive safety and pharmacokinetic (PK) data; once-daily dosing feasible. EDP-938 in Phase 2 studies for pediatric, adult high-risk, and hematopoietic cell transplant RSV patients with enrollment ongoing in multiple sites.
• COVID-19 Program: Additional analysis from Phase 2 ARS-CoV-2 SPRINT study on EDP-235 showed antiviral effects and symptom improvement in mild/moderate COVID-19 patients.
• Dual Inhibitor Research: Plan to select a clinical candidate for HMPV and RSV in Q4 2023, with preclinical data showing potent inhibition of both viruses.
• Hepatitis B: Monitoring for compounds to combine with EDP-514, a core inhibitor with FDA fast track designation.

Total revenue for the fiscal third quarter 2023 was $18.9 million, consisting of royalty revenue from AbbVie’s MAVYRET, compared to $19.5 million in the same period of 2022. Research and development expense for the three-months ended June 30, 2023 was $43 million, up from $39.1 million in 2022. General and administrative expense was $12.6 million in Q3 2023 vs $12.9 million in 2022. Net loss for the period was $39.1 million, or $1.86 per diluted common share, compared to a net loss of $31.7 million, or $1.53 per diluted common share in 2022. Enanta ended the quarter with approximately $392.5 million in cash and marketable securities.

• Revised guidance for fiscal 2023: Research and development expense expected to be between $165M and $175M; general and administrative expense between $50M and $55M.
• Cash and marketable securities should be sufficient to meet cash requirements into the second half of fiscal 2027.
• Focus on partnering for COVID-19 Phase 3 clinical development work.

• Uncertainty in regulatory pathways for COVID-19 and RSV programs.
• Impact of virus variability and vaccination rates on the success of COVID-19 and RSV programs.
• Dependence on a partner for advancing COVID-19 Phase 3 trials.

Q: Elaborate on combinability and complementarity between EDP-323 and EDP-938.

A: 323 is an L-inhibitor and 938 is an N-inhibitor; preclinically they behave well together. 938 could be standalone for garden variety RSV, 323 could also perform well as a single agent, with insights to come from the human challenge study.

Q: Implications of nucleocapsid negative patient data in COVID program and regulatory path forward.

A: Data shows viral load reductions in nucleocapsid negative patients, but approval will be based on symptoms and outcomes. In communication with regulators on pathways to approval, plan to conduct future COVID work in partnership.

Q: RSV Phase 2 studies enrollment speed and readout plans for 2024.

A: RSV Phase 2 studies have large site footprints; enrollment varies by patient population. Will read out results sequentially as they become available, with each trial having different patient populations.

Q: Benchmarking for EDP-323 Human Challenge study and comparison to EDP-938.

A: EDP-938 is the benchmark; study design similar to 938's, focusing on drug vs placebo to assess antiviral effect, with 938 showing robust antiviral effects in prior challenge studies.

Q: Cash runway extension drivers and portfolio prioritization.

A: Extension due to waiting for partnering on COVID-19 Phase 3 work; primary driver is expense sparing from delaying Phase 3 trials, with no other major portfolio prioritization changes mentioned