Entasis Therapeutics Reports Second Quarter 2019 Financial Results and Provides Business Update
“We continued to make steady progress across all our pipeline programs in the first half of 2019,” commented Manos Perros, President and Chief Executive Officer of
Second Quarter and Recent Business Highlights
- In April, Entasis initiated the ATTACK Phase 3 pivotal clinical trial to evaluate SUL-DUR for the treatment of patients with pneumonia and bloodstream infections caused by carbapenem-resistant A. baumannii. ATTACK is a global, two-part Phase 3 clinical trial that will enroll a total of 300 patients. Topline results from the study are expected to be available in second half of 2020.
- In June, the Company reported preliminary results from its randomized, double-blind, placebo-controlled Phase 1 clinical study of ETX0282, an oral beta-lactamase inhibitor, being developed to combat multidrug-resistant Enterobacteriaceae. The trial is evaluating the safety, tolerability and pharmacokinetics of ETX0282 either alone or in combination with cefpodoxime proxetil (ETX0282CPDP) in healthy volunteers. Results demonstrated that the plasma concentrations of the beta-lactamase inhibitor were in the projected therapeutic range. ETX0282 was generally well tolerated either alone or in combination with cefpodoxime proxetil, with no serious adverse events reported.
- The Company strengthened its board with the appointment of industry veteran,
David Meek, as the Chairman of the Board of Directors. Mr. Meek has over two decades of valuable healthcare industry experience and is currently CEO and a Director of Ipsen S.A.
- The Company also strengthened the management team with the additions of
Eric Kimbleas Chief Commercial Officer, Elizabeth Keileyas General Counsel and Andrew Dawsonas Head of Human Resources.
- At the
American Society for Microbiology (ASM) Microbe Conference, Entasis presented new findings supporting development of the Company’s three clinical programs: SUL-DUR, zoliflodacin and ETX0282CPDP. During the conference the Company presented data on the pharmacokinetics and pharmacodynamics for SUL-DUR which formed the basis of the dosing regimen tested in the Phase 2 clinical trial and the ongoing ATTACK Phase 3 clinical trial.
Second Quarter Financial Results
The Company reported a net loss of
Research and development expenses were
General and administrative expenses were
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’ pathogen-targeted design platform has produced a pipeline of product candidates, including sulbactam-durlobactam (targeting Acinetobacter 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. 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 June 30,||Six Months Ended June 30,|
|Research and development||10,677||9,479||21,679||18,029|
|General and administrative||3,421||2,548||6,609||5,766|
|Total operating expenses||14,098||12,027||28,288||23,795|
|Loss from operations||(14,098||)||(7,027||)||(28,288||)||(18,795||)|
|Total other income||789||1,766||2,109||2,867|
|Loss before income taxes||(13,309||)||(5,261||)||(26,179||)||(15,928||)|
|Provision for income taxes||73||472||144||472|
|Net loss per share—basic and diluted||$||(1.02||)||$||(453.60||)||$||(2.00||)||$||(1,297.57||)|
|Weighted average common stock outstanding—basic and diluted||13,131,291||12,639||13,128,956||12,639|
|Entasis Therapeutics Holdings Inc.|
|Condensed Consolidated Balance Sheets|
|June 30,||December 31,|
|Cash, cash equivalents and investments||$||59,473||$||85,092|
|Total stockholders' equity||57,840||82,883|
|Total liabilities and stockholders’ equity||$||66,489||$||89,274|
Source: Entasis Therapeutics Holdings Inc.