Entasis Therapeutics Announces First Quarter 2022 Financial Results and Provides Business Update
- Highlights of landmark Phase 3 ATTACK trial for sulbactam-durlobactam (SUL-DUR) presented at ECCMID 2022 annual conference
SUL-DUR NDAsubmission on track for mid-2022
- Zoliflodacin Phase 3 trial progressing; enrollment completion now anticipated in 2023
“During our first quarter we continued to advance our pipeline and lay the foundations of our development into a fully-integrated entity with research, development and commercialization capabilities. Our focus remains on the preparation of our NDA for sulbactam-durlobactam (SUL-DUR) that we expect to file with the FDA in mid-2022. We were pleased to see data from our landmark Phase 3 ATTACK trial for SUL-DUR featured prominently at this year’s ECCMID conference, and are confident that if approved, SUL-DUR has the potential to become the life-saving treatment of choice for patients with drug resistant Acinetobacter infections. We also continue to advance the rest of our pipeline, led by the zoliflodacin Phase 3 registrational trial, that we anticipate will complete enrollment in 2023. For the remainder of 2022, we will continue to focus our current resources on the SUL-DUR NDA, while preparing for commercialization in the US should the product be approved. We will also continue supporting our partner GARDP to complete the zoliflodacin Phase 3 trial, and invest responsibly in advancing our earlier pipeline, including ETX0462, the first in a new class of agents with activity against multiple Gram-negative pathogens including Pseudomonas aeruginosa and multiple high-priority biothreat pathogens.”
- Multiple presentations on SUL-DUR were delivered at the European
Congressof Clinical Microbiology and Infectious Diseases (ECCMID) annual conference, held April 23-26, 2022.
- Two oral presentations presented by Drs.
Alita Miller, Vice President, Microbiology and David Altarac, Chief Medical Officer, highlighted topline results and sub-analysis from the landmark ATTACK Phase 3 Trial
- Five poster presentations also highlighted additional SUL-DUR and ATTACK details and results
- Two oral presentations presented by Drs.
- The Company is on track for submission of the NDA for SUL-DUR to the FDA 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 14 clinical trial sites across the United States, the Netherlands, South Africaand Thailand. Given the improved progress with enrollment over the past 3 quarters, we now anticipate completion of trial enrollment in 2023.
February 1, 2022, the Company’s Board of Directors received a preliminary, non-binding proposal from its majority stockholder Innoviva Inc. (“Innoviva”), to acquire all the outstanding equity securities of the Company that are not currently owned by Innoviva for a per share consideration of $1.80, payable in cash. On March 15, 2022, Innoviva revised its non-binding offer to acquire the Company to increase the per share consideration to $2.00. All other terms of the offer remain unchanged. The offer letters delivered by Innoviva to the Board of Directors are publicly available in the Schedule 13D amendments dated February 1, 2022 and March 15, 2022, filed by Innoviva with the Securities and Exchange Commission. The Board of Directors of Entasis, which does not include any members appointed by or affiliated with Innoviva, has retained MTS Health Partners, L.P. and Covington & Burling LLP to explore alternatives and to assist the board of directors in its evaluation of the proposal consistent with its fiduciary duties.
Innoviva Private Placement
February 18, 2022, the Company issued and sold to Innoviva, in a private placement, a convertible promissory note. The gross proceeds to the Company from the transaction totaled $15 million. The company intends to use the proceeds primarily for the NDA filing preparation and other general corporate purposes.
2022 First 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
Entasis is an advanced late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted antibacterial products that address high unmet medical needs to treat serious infections caused by multidrug-resistant pathogens. 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
|Company Contact||Investor Contact|
|(781) 810-0114||(929) 469-3859|
|(215) 315 3143|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended
|Research and development||$||10,992||$||9,370|
|General and administrative||4,936||3,307|
|Total operating expenses||15,928||12,677|
|Loss from operations||(15,928||)||(12,677||)|
|Total other income||666||1,976|
|Net loss per share—basic and diluted||$||(0.32||)||$||(0.29||)|
|Weighted average common stock outstanding—basic and diluted||47,851,779||37,078,478|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and investments||$||33,547||$||32,307|
|Total stockholders' equity||16,647||31,212|
|Total liabilities and stockholders’ equity||$||44,090||$||40,920|
Source: Entasis Therapeutics Holdings Inc.