Entasis Therapeutics Announces Third Quarter 2021 Financial Results and Provides Business Update
- Sulbactam-durlobactam (SUL-DUR) achieved all primary and secondary endpoints from landmark Phase 3 ATTACK trial
- Robust dataset builds compelling case for SUL-DUR which if approved, could become the first, uniquely differentiated and life-saving treatment option for patients with Acinetobacter infections
- Preparing for commercialization ahead of NDA submission in mid-2022, under the leadership of newly appointed Chief Commercial Officer
Anna Diaz Triola
- Entasis’ pathogen-directed platform and latest candidate ETX0462 highlighted by seminal publication in the prestigious scientific journal Nature
“The past few weeks have been an exciting period for Entasis, with announcement of topline data from the landmark Phase 3 ATTACK trial in patients with Acinetobacter infections, where SUL-DUR achieved all primary and secondary endpoints,” said
Third Quarter and Recent Weeks Highlights
- The Company, and its partner Zai Lab (Nasdaq: ZLAB), announced topline data from ATTACK, a single Phase 3 registrational trial that evaluated the safety and efficacy of SUL-DUR in patients with confirmed carbapenem-resistant Acinetobacter infections. SUL-DUR achieved the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections (CRABC m-MITT* population in Part A of the study), demonstrating statistical non-inferiority versus colistin. Mortality analyses in all pre-specified populations included in the topline results unequivocally favored SUL-DUR versus colistin. At Test of Cure, there was a statistically significant difference in clinical cure rate favoring SUL-DUR over colistin. SUL-DUR also met the primary safety objective of the study achieving statistically significant reduction in nephrotoxicity.
- The Company is currently planning for a NDA submission in mid-2022.
- The Company continues to support its partner, the
Global Antibiotic Research and Development Partnership(GARDP), and its Phase 3 registrational trial of zoliflodacin for the treatment of uncomplicated gonorrhea. The trial will assess the safety and efficacy of oral zoliflodacin versus the current standard of care combination of intramuscular ceftriaxone plus oral azithromycin. The trial continues to actively enroll patients with uncomplicated gonorrhea, including infections potentially caused by multidrug-resistant strains of N. gonorrhoeae at 12 clinical trial sites across the United States, the Netherlands, South Africaand Thailand, including 6 new sites activated since the start of the year.
- In pre-clinical data presented at the
World Microbe Forum, ETX0462 exhibited robust antibacterial activity against multiple Gram-negative pathogens, and bactericidal activity reaching >3-log drop vs. initial inoculum in a neutropenic murine lung model against clinical isolates of P. aeruginosa. Similar in vivo efficacy was also demonstrated for the biothreat pathogens Y. pestis and B. pseudomallei. The scientific platform from which ETX0462 was developed and its preclinical profile were the subject of a recent publication in the prestigious journal Nature.
Corporate & Business Highlights
- In July, the Company announced the appointment of
Anna Diaz Triolaas its Chief Commercial Officer, with responsibilities for global commercial strategy including U.S.sales and marketing operations. Ms. Triola previously served as the Vice President, Marketing at Summit Therapeutics, and prior to that held leadership roles at Flexion Therapeutics, Chiasma, Cubist, and Biogen.
Third Quarter Financial Results
The Company reported a net loss of
Research and development expenses were
General and administrative expenses were
*Carbapenem-resistant Acinetobacter baumannii-calcoaceticus Complex Microbiologically Modified Intent-to-Treat Population
Conference Call & Webcast
The company will host a conference call and webcast at
Entasis is a late-stage clinical 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 SUL-DUR (targeting Acinetobacter baumannii infections), zoliflodacin (targeting Neisseria gonorrhoeae infections), ETX0282CPDP (targeting Enterobacterales infections) and ETX0462 (targeting Gram-negative infections including Pseudomonas). 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 “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative or plural of those terms, and similar expressions are intended to identify forward-looking statements. These statements relate to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements 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, rejection of our regulatory submissions, 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
Research on ETX0462 reported in this news release is partially supported by CARB-X. CARB-X’s funding for this project is sponsored by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by an award from
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---tables to follow---
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended
||Nine Months Ended
|Research and development||$||9,282||$||9,387||$||28,638||$||31,249|
|General and administrative||4,320||3,213||10,938||10,235|
|Total operating expenses||13,602||12,600||39,576||41,484|
|Loss from operations||(13,602||)||(12,600||)||(39,576||)||-||(41,484||)|
|Total other income||1,211||1,467||4,454||1,689|
|Net loss per share—basic and diluted||$||(0.26||)||$||(0.37||)||$||(0.84||)||$||(1.97||)|
|Weighted average common stock outstanding—basic and diluted||47,310,254||29,960,219||41,869,412||20,151,570|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and investments||$||44,124||$||53,247|
|Total stockholders' equity||41,235||52,289|
|Total liabilities and stockholders’ equity||$||50,766||$||61,558|
Source: Entasis Therapeutics Holdings Inc.