Entasis Therapeutics Reports First Quarter 2019 Financial Results and Provides Business Update
“We believe 2019 will be a transformative year for Entasis as we advance our late-stage pipeline and expand our leadership team,” commented Manos Perros, President and Chief Executive Officer of
First Quarter and Recent Business Highlights
- Recently, the Company launched its Phase 3 clinical trial of ETX2514SUL, ATTACK (Acinetobacter Treatment Trial Against Colistin), as a potential treatment for infections caused by carbapenem-resistant A. baumannii. ATTACK is a two-part global study that will enroll a total of 300 patients.
The U.S. Food and Drug Administration( FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to ETX2514SUL.
- The Company strengthened its management team with the appointment of
Eric Kimbleas Chief Commercial Officer to build and oversee the Company’s global commercialization strategy and product launch initiatives. Mr. Kimble has over 25 years of commercial leadership experience in sales, marketing and commercial strategy, and product launches from Cubist Pharmaceuticals, Biogen Inc.and Merck & Co.
- In April,
Elizabeth Keileywas appointed General Counsel and is responsible for leading the Company’s legal, governance and compliance initiatives. Ms. Keiley will be instrumental in supporting our commercialization efforts while ensuring compliance with applicable laws and regulations and the protection of Entasis’ intellectual property, including patents and FDAdesignation.
- Entasis presented promising findings from multiples studies related to its clinical assets, ETX2514SUL and ETX0282CPDP, as well as its preclinical non-beta-lactam PBP inhibitor (NBP) program at the 29th
European Congress of Clinical Microbiology & Infectious Diseases(ECCMID) in Amsterdam, Netherlands. These data presentations highlighted the Company’s pipeline of innovative antimicrobial assets and their potential value as therapeutic agents.
First Quarter Financial Results
The Company reported a net loss of
Research and development expenses were
General and administrative expenses remained flat at
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
(Financial Tables Follow)
|Entasis Therapeutics Holdings Inc.|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended March 31,|
|Research and development||$||11,002||$||8,550|
|General and administrative||3,189||3,218|
|Total operating expenses||14,191||11,768|
|Loss from operations||(14,191||)||(11,768||)|
|Total other income||1,321||1,101|
|Loss before income taxes||(12,870||)||(10,667||)|
|Provision for income taxes||71||-|
|Net loss per share—basic and diluted||$||(0.99||)||$||(844.01||)|
|Weighted average common stock outstanding—basic and diluted||13,126,595||12,639|
|Entasis Therapeutics Holdings Inc.|
|Condensed Consolidated Balance Sheets|
|March 31,||December 31,|
|Cash, cash equivalents and investments||$||74,555||$||85,092|
|Total stockholders' equity||70,574||82,883|
|Total liabilities and stockholders’ equity||$||81,267||$||89,274|
Source: Entasis Therapeutics Holdings Inc.