Enanta Pharmaceuticals, Inc.

Total revenue for fiscal Q2 was $17.1 million versus $17.8 million in the same period of 2023. R&D expense was $35.6 million, down from $43.5 million year over year, while G&A expense was $14.2 million versus $13.8 million. Net loss was $31.2 million, or $(1.47) per diluted share, compared with a net loss of $37.7 million, or $(1.79) per diluted share, a year ago. The company ended the quarter with approximately $300 million in cash and marketable securities. Full-year expense guidance was updated: R&D is expected to be $125 million-$145 million and G&A $50 million-$60 million. Management said existing cash plus retained royalties should fund operations through the third quarter of fiscal 2027.

Jay Luly said Enanta is focused on advancing an oral virology and immunology pipeline into areas of high unmet need, with RSV and CSU as the main near-term inflection points. He emphasized that the company wants to build a leadership position in RSV and potentially use multiple non-cross-resistant antivirals alone or in combination. On immunology, he highlighted a plan to move a selective oral KIT inhibitor into the clinic, then expand into additional targets later this year.

Paul Mellett said revenue was entirely MAVYRET royalty income, with fiscal Q2 pressured by the lower 10% royalty tier versus 12% in the prior quarter. He noted that 54.5% of ongoing royalties go to OMERS under the April 2023 royalty sale, and that interest expense on the related debt was $2.6 million for the quarter. R&D fell to $35.6 million from $43.5 million mainly because COVID-19 spending declined, partly offset by higher RSV and immunology costs, while G&A rose to $14.2 million due mainly to legal expenses tied to the Pfizer patent case. He said the company’s cash and royalties should be sufficient through the third quarter of fiscal 2027.

Analysts focused on what data would be enough for RSVPEDs to support Phase III, since the study is a proof-of-concept pediatric trial rather than a fully powered efficacy study. Management said it will look at the totality of virology, safety and clinical trends, with no fixed efficacy bar, but wants directional virology improvement versus placebo; they cited the lack of strong natural-history data in pediatric RSV and referenced an external study showing a 0.6 log viral-load drop as context. Questions also covered the KIT program, where management said the near-term plan is to select a QD oral candidate in Q4, use serum tryptase as an early target-engagement biomarker, and then run a straightforward proof-of-concept CSU study. On EDP-323, management said it will not pursue otherwise healthy adults again and will wait for the challenge study and RSVPEDs/RSVHR data to decide positioning, including whether combination therapy or high-risk populations make the most sense.