Entasis Therapeutics Reports Full Year 2018 Financial Results and Provides Business Update
On track to commence two Phase 3 clinical trials in 2019
WALTHAM, Mass., March 29, 2019 -- Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced its full year 2018 financial results and provided a business update.
“In 2018, we made tremendous progress on a number of fronts which we believe have positioned the Company for continued advancement in 2019,” commented Manos Perros, President and Chief Executive Officer of Entasis Therapeutics. “We have a number of important near-term milestones we are working toward, including the imminent launch of our Phase 3 clinical trial of ETX2514SUL for infections caused by carbapenem-resistant Acinetobacter baumannii (A. baumannii). We also plan to initiate the Phase 3 clinical trial of zoliflodacin for the treatment of Neisseria gonorrhoeae infections, including drug-resistant strains, in collaboration with the Global Antibiotic Research and Development Partnership (GARDP) in mid-2019. In addition, we are developing ETX0282CPDP for the treatment of complicated urinary tract infections caused by multidrug-resistant Enterobacteriaceae, with data from the Phase 1 clinical trial expected in mid-2019.”
Fourth Quarter and Recent Business Highlights
Based on feedback from the Company’s end-of-Phase-2 meeting with the U.S. Food and Drug Administration regarding the further clinical development of ETX2514SUL for the treatment of infections caused by carbapenem-resistant A. baumannii, the Company is in the process of initiating the Phase 3 clinical trial for ETX2514SUL with data expected to be available in the second half of 2020.
Entasis entered into an agreement with bioMérieux and intends to incorporate BIOFIRE® FILMARRAY® Instruments and the BIOFIRE® FILMARRAY® Pneumonia Panel into its global Phase 3 clinical trial of ETX2514SUL for enrollment optimization. This panel allows for fast, accurate, and comprehensive syndromic testing for lower respiratory tract infections and enables identification of 33 targets, including A. baumannii, either directly from sputum or bronchoalveolar lavage samples.
Entasis and its collaborator GARDP intend to initiate a Phase 3 clinical trial of zoliflodacin for the treatment of uncomplicated gonorrhea in mid-2019 with data expected in 2021. The Phase 3 clinical trial will be funded and conducted by GARDP.
The Company completed its initial public offering in September 2018 resulting in net cash proceeds of approximately $65.6 million. The proceeds from this offering are being used to fund business operations and further development of Entasis’ novel pipeline of antibacterial candidates, including the Phase 3 clinical trial of ETX2514SUL, the Phase 3 clinical trial of zoliflodacin, the Phase 1 clinical trial of ETX0282CPDP and the advancement of other preclinical product candidates.
Full Year Financial Results
Entasis reported revenue of $5.0 million and grant income of $5.3 million for the year ended December 31, 2018, compared to no revenue and $1.4 million of grant income for the year ended December 31, 2017. The revenue in 2018 was attributable to the upfront payment from Zai Lab (Shanghai) Co., Ltd. following the licensing of commercial rights to ETX2514SUL in Asia-Pacific territories.
The Company reported a net loss of $33.0 million for the year ended December 31, 2018, compared to a net loss of $29.9 million for the year ended December 31, 2017. The increase in net loss was primarily related to increases in research and development and general and administrative expenses, partially offset by increases in other income.
Research and development expenses were $33.0 million for the year ended December 31, 2018, compared to $25.7 million for the year ended December 31, 2017. The increase in research and development expenses was primarily attributable to preclinical, clinical and CMC development expenses related to the advancement of ETX2514SUL and the Company’s NBP and other preclinical programs.
General and administrative expenses were $10.2 million for the year ended December 31, 2018, compared to $5.6 million for the year ended December 31, 2017. The increase in general and administrative expenses was primarily attributable to increased legal and professional fees associated with the Company’s initial public offering, as well as expenses of being a public company.
Entasis ended the year with $85.1 million in cash, cash equivalents and short-term investments compared to $55.1 million as of December 31, 2017. The increase was attributable to the proceeds from the Company’s initial public offering in September 2018, partially offset by cash used in operating activities. We believe that our existing cash, cash equivalents and short-term investments at December 31, 2018 will be adequate to satisfy our capital needs into the fourth quarter of 2020 based on our current operating plans, which includes top-line data read-out of the ETX2514SUL Phase 3 clinical trial.
Entasis is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ targeted-design platform has produced a pipeline of product candidates, including ETX2514SUL (targeting A. baumannii infections), zoliflodacin (targeting Neisseria gonorrhoeae), and ETX0282CPDP (targeting Enterobacteriaceae infections). Entasis is also using its platform to develop a novel class of antibiotics, non-β-lactam inhibitors of the penicillin-binding proteins (NBPs) (targeting Gram-negative infections). For more information, visit www.entasistx.com.
(Please see attached for full press release including financial tables)
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