Entasis Therapeutics Reports Full Year 2018 Financial Results and Provides 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
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 Administrationregarding 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 Panelinto 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 2018resulting 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
The Company reported a net loss of
Research and development expenses were
General and administrative expenses were
Entasis ended the year with
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.
Entasis Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Entasis’ expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding (i) the progress, timing and results of Entasis’ clinical trials; (ii) design of the Phase 3 clinical trial of ETX2514SUL, including plans to incorporate BIOFIRE Instruments and Pneumonia Panels into this trial; (iii) GARDP’s role in the Phase 3 clinical trial of zoliflodacin; and (iv) use of proceeds from the initial public offering. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during non-clinical or clinical studies, clinical site activation rates or clinical trial enrollment rates that are lower than expected and changes in expected or existing competition, changes in the regulatory environment, failure of Entasis’ collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Many of these factors are beyond Entasis’ control. These and other risks and uncertainties are described more fully in the Entasis’ filings with the
Investor Relations Contact
|Entasis Therapeutics Holdings Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Year Ended December 31,|
|Research and development||33,046||25,745|
|General and administrative||10,161||5,599|
|Total operating expenses||43,207||31,344|
|Loss from operations||(38,207||)||(31,344||)|
|Total other income||5,727||1,421|
|Loss before income taxes||(32,480||)||(29,923||)|
|Provision for income taxes||472||-|
|Net loss attributable to common stockholders—basic and diluted||$||(42,094||)||$||(29,923||)|
|Net loss per share attributable to common stockholders—basic and diluted||$||(12.31||)||$||(13,795.76||)|
|Weighted average common stock outstanding—basic and diluted||3,419,720||2,169|
|Entasis Therapeutics Holdings Inc.|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and investments||$||85,092||$||55,101|
|Total stockholders' equity (deficit)||82,883||(55,790||)|
|Total liabilities, preferred stock and stockholders’ equity (deficit)||$||89,274||$||58,794|
Source: Entasis Therapeutics Holdings Inc.