General and administrative expenses totaled $6.9 million for the three months ended December 31, 2019 compared to $7.2 million for the three months ended December 31, 2018.
Enanta recorded income tax expense of $1.5 million for the three months ended December 31, 2019 compared to an income tax expense of $3.7 million for the same period in 2018. Enanta’s effective tax rate for the December 31, 2019 quarter was approximately 10 percent compared to approximately 12.5 percent for the corresponding period in 2018. The decrease quarter over quarter was due primarily to increased research and development tax credits and a federal income tax benefit from foreign-derived royalty income.
Net income for the three months ended December 31, 2019 was $13.4 million, or $0.65 per diluted common share, compared to net income of $26.0 million, or $1.25 per diluted common share, for the corresponding period in 2018.
Enanta’s cash, cash equivalents and short-term and long-term marketable securities totaled $414.7 million at December 31, 2019. This compares to a total of $400.2 million at September 30, 2019. Enanta expects that its current cash, cash equivalents and marketable securities, as well as its continuing royalty revenue, will be sufficient to meet the anticipated cash requirements of its existing business and development programs for the foreseeable future.
Phase 1 data for core inhibitorEDP-514 for HBV
The Phase 1 randomized, double-blind, placebo-controlled,first-in-human study ofEDP-514 was conducted to evaluate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple- (14 days) ascending doses ofEDP-514 in healthy subjects.
Overall,EDP-514 in healthy subjects dosed for up to 14 days was well tolerated with a favorable safety profile; treatment emergent adverse events were infrequent and mild in intensity; no one discontinuedEDP-514 due to adverse events; and there were no significant individual lab data findings or pattern of lab abnormalities. Additionally, the pharmacokinetic (blood level) profile was fully supportive of once daily dosing.
Following these results, which support further clinical evaluation ofEDP-514 in HBV patients, Enanta has initiated a study in patients with chronic HBV infection that is being suppressed withnucleos(t)ide-reverse-transcriptase treatment(nuc-suppressed patients). A further study is planned in patients with chronic HBV infection who are not on therapy and have high levels of virus in their blood (viremic patients).
Further details of results from this Phase 1a study will be presented at the International Liver Congress™, April15-20, 2020.
Near-term Milestones
| • | | RSV:N-inhibitorEDP-938 and human metapneumovirus (hMPV) Inhibitor Leads |
| • | | Due to an apparent December peak in the RSV season in North America, continue enrollment in RSVP study ofEDP-938 in adult RSV outpatients, including in the Southern Hemisphere, with the goal of having data in the first half of 2021 |
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