Entasis Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update
-Management to Host Conference Call on
- Patient Enrollment in the ATTACK Phase 3 Registrational Trial Completed; Top-Line Data Readout Expected Early Fourth Quarter 2021
- SUL-DUR Launch Planning Progresses with Appointment of
Anna Diaz Triolaas Chief Commercial Officer
- Data On SUL-DUR and ETX0462 Presented at
World Microbe Forum $20 MillionPrivate Placement Transaction Completed with Innoviva
“During our second quarter and in recent weeks we continued to build upon the momentum in our clinical programs that began earlier in the year. We completed enrollment in the ATTACK Phase 3 registrational trial which is evaluating sulbactam-durlobactam (SUL-DUR) for the treatment of carbapenem-resistant Acinetobacter infections, and continued enrollment in the Phase 3 registrational trial that is evaluating zoliflodacin for the treatment of uncomplicated gonorrhea,” said
Second Quarter 2021 and Recent Highlights
- The Company, along with its partner Zai Lab (NASDAQ: ZLAB), announced the completion of patient enrollment in ATTACK, a single Phase 3 registrational trial that is evaluating the safety and efficacy of SUL-DUR in patients with confirmed carbapenem-resistant Acinetobacter infections. Over 120 evaluable patients were enrolled into the primary efficacy arm, sufficient to complete the trial. The Company anticipates top-line data readout early in the fourth quarter.
- The Company will host an Expert Perspectives on Acinetobacter Infections Webinar,
Tuesday, August 24, at 10:00 AM ET. This program will feature presentations by Infectious Disease experts Dr. David van Duinof the University of North Carolinaand Dr. Michael J. Rybakof Wayne State University, whowill discuss the burden and current treatment landscape of Acinetobacter infections. The program is open to all interested parties, and registration is available here or on our website www.entasistx.com.
- Entasis presented 7 posters and one oral presentation highlighting ETX0462, a novel, first-in-class, diazabicyclooctane with antimicrobial activity against multiple Gram-negative pathogens including Pseudomonas aeruginosa as well as a number of high-priority biothreat pathogens. This novel class of agents is designed to potentially target a broad spectrum of multidrug resistant bacterial pathogens that are included in both the
Center for Disease Controland World Health Organizationlists of high unmet medical need pathogens. Presentations also included updates on SUL-DUR and ETX0282CPDP, an oral β-lactam/β-lactamase inhibitor being developed to treat multidrug-resistant Gram-negative pathogens, including those caused by extended-spectrum β-lactamases (ESBLs) and carbapenem-resistant Enterobacteriaceae (CRE).
Corporate & Business Highlights
- The Company appointed
Anna Diaz Triolaas its Chief Commercial Officer, effective July 19, 2021. Ms. Triola brings over 20 years of experience in the launch and commercialization of products across multiple therapeutic areas and diverse settings of care, including the hospital and community. She previously served as the Vice President, Marketing at Summit Therapeutics where she was instrumental in developing the commercial strategy for the company’s first product against C. difficile infections. Prior to joining Summit, Ms. Triola held commercial leadership roles at Flexion Therapeutics, Chiasma, Cubist, and Biogen. Ms. Triola holds an M.B.A from Harvard Business School and a B.A. from Wellesley College.
- The Company completed a private placement to sell Entasis common stock and warrants to a wholly-owned subsidiary of Innoviva Inc. (Nasdaq: INVA), Entasis’ largest shareholder. The gross proceeds to the Company from the transaction totaled
$20 million, before deducting offering expenses payable by the Company. The Company intends to use the net proceeds for completing the ATTACK trial, NDA filing preparation, SUL-DUR launch readiness as well as working capital and other general corporate purposes.
Second Quarter Financial Results
The Company reported a net loss of $12.0 million for the three months ended June 30, 2021, compared to a net loss of $13.4 million for the three months ended June 30, 2020. The decrease in net loss was primarily related to an increase in grant income during the second quarter of 2021 versus the prior year.
Research and development expenses were $10.0 million during the three months ended June 30, 2021, compared to $10.2 million during the three months ended June 30, 2020. The decrease of
General and administrative expenses were $3.3 million for the three months ended June 30, 2021, compared to $3.2 million during the three months ended June 30, 2020. The increase of
As of June 30, 2021, cash and cash equivalents were $56.4 million, compared to $53.2 million as of December 31, 2020. Based our current operating plan, we believe that our existing cash and cash equivalents, including amounts received from the most recent private offering, will be sufficient to fund our operating expenses and capital expenditure requirements through the second quarter of 2022.
Investors and the general public are invited to listen to a live audio webcast of the conference call, which may be accessed five minutes prior to the start of the call by dialing 877-407-4018 (
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), ETX0462 (targeting multiple Gram-negative pathogens including Pseudomonas aeruginosa) and ETX0282CPDP (targeting Enterobacteriaceae 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
Investor Relations Contacts
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended
||Six Months Ended
|Research and development||$||9,986||$||10,239||$||19,356||$||21,862|
|General and administrative||3,311||3,241||6,618||7,021|
|Total operating expenses||13,297||13,480||25,974||28,883|
|Loss from operations||(13,297||)||(13,480||)||(25,974||)||(28,883||)|
|Total other income||1,267||84||3,243||221|
|Net loss per share—basic and diluted||$||(0.29||)||$||(0.78||)||$||(0.58||)||$||(1.89||)|
|Weighted average common stock outstanding—basic and diluted||41,107,067||17,095,140||39,103,901||15,193,351|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and investments||$||56,406||$||53,247|
|Total stockholders' equity||53,060||52,289|
|Total liabilities and stockholders’ equity||$||63,565||$||61,558|
Source: Entasis Therapeutics Holdings Inc.