Entasis Therapeutics Reports Full Year 2019 Financial Results and Business Update
“2019 marked a pivotal year for the Company as we made great strides both advancing our clinical programs and strengthening our leadership team,” stated
Full Year 2019 and Recent Highlights
- In April, we initiated the ATTACK Phase 3 registration trial to evaluate SUL-DUR for the treatment of patients with pneumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii. ATTACK is a global, two-part Phase 3 registration trial set to enroll a total of approximately 300 patients. As pre-planned, after randomization of approximately 40 patients into the primary efficacy arm (Part A, which will include a total of 136 evaluable patients), the Data Safety Monitoring Board, or
DSMB, conducted a pre-specified pharmacokinetics assessment to confirm our projected SUL-DUR exposures. Although we remain blinded to treatment assignment, the DSMBhas advised us to continue enrollment without modification of the trial protocol and in addition has allowed us to open the Part B arm of the trial, which is an open-label treatment of approximately 80 patients with Acinetobacter infections who are not otherwise eligible for the randomized comparison. Due to the coronavirus outbreak in countries where we are conducting the ATTACK registration trial, we now anticipate topline results from the study to be available in early 2021. This is a change from our previous guidance of the second half of 2020 as we anticipate some effect on the ATTACK trial timeline from this epidemic, the extent of which we continue to monitor and are working to mitigate.
- In September, the
Global Antibiotic Research and Development Partnership(GARDP) initiated the global Phase 3 registration trial of zoliflodacin for the treatment of uncomplicated gonorrhea. The randomized, open label trial will enroll approximately 1,000 adults with urogenital gonorrhea at clinical trial sites in the United Statesand internationally and will assess the safety and efficacy of zoliflodacin versus the combination of azithromycin and ceftriaxone, the current standard of care. GARDP is fully funding and sponsoring the Phase 3 trial. In return, the Company has provided them with exclusive commercial rights in low-income and select middle-income countries. A data readout from the Phase 3 registration trial is expected in 2021.
- 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 was designed to evaluate the safety, tolerability and pharmacokinetics of ETX0282 either alone or in combination with cefpodoxime proxetil (ETX0282CPDP) in healthy volunteers. Results from the Phase 1 clinical study demonstrated that plasma concentrations of the beta-lactamase inhibitor were in the projected therapeutic range. Additionally, ETX0282 was generally well tolerated either alone or in combination with cefpodoxime proxetil, and no serious adverse events were reported. Modified-release formulation efforts are now ongoing.
- In December the Company selected ETX0462 as a clinical candidate from its non-b-lactam penicillin binding protein inhibitor (NBP) program. ETX0462 potentially represents a new Gram-negative class of antibiotics and is initially being developed for the treatment of multidrug-resistant Pseudomonas infections. Data from the program will be presented at an upcoming medical conference.
- The Company strengthened its management team with the appointment of key industry leaders including
Eric Kimbleas Chief Commercial Officer to build and oversee the Company’s global commercialization strategy and product launch initiatives. Mr. Kimble, who was appointed in April, 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 November, the Company also appointed David Altarac, M.D., MPA as Chief Medical Officer. Dr. Altaracis a recognized industry R&D leader and brings broad experience, most recently as senior vice president and head of global regulatory affairs, global drug safety and R&D quality and compliance at Shire Plc.
Full Year 2019 Financial Results
Entasis reported revenue of
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 infections), ETX0282CPDP (targeting Enterobacteriaceae infections) and ETX0462 (targeting Pseudomonas 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)
|Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Research and development||40,166||33,046|
|General and administrative||13,770||10,161|
|Total operating expenses||53,936||43,207|
|Loss from operations||(46,936)||(38,207)|
|Total other income||3,763||5,727|
|Loss before income taxes||(43,173)||(32,480)|
|Provision for income taxes||677||472|
|Net loss attributable to common stockholders—basic and diluted||$||(43,850)||$||(42,094)|
|Net loss per share—basic and diluted||$||(3.33)||$||(12.31)|
|Weighted average common stock outstanding—basic and diluted||13,160,357||3,419,720|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and short-term investments||$||40,996||$||85,092|
|Total stockholders' equity||42,157||82,883|
|Total liabilities and stockholders’ equity||$||51,034||$||89,274|
Source: Entasis Therapeutics Holdings Inc.