Entasis Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update
– ATTACK Phase 3 topline data readout remains on track for second half of 2021 –
– Strengthened balance sheet with
“Through the dedication of our employees and partners, we have maintained momentum in our Phase 3 registrational trials addressing multidrug-resistant Acinetobacter infections and uncomplicated gonorrhea,” commented
First Quarter 2021 and Recent Highlights
- Business Highlights
The Company, along with our partner
Zai Lab(Nasdaq: ZLAB), has enrolled 108 patients with confirmed carbapenem-resistant Acinetobacter infections in the ATTACK trial. The Company estimates that the ATTACK trial is approximately 90% enrolled and expects to complete enrollment in the coming weeks and remains on-track for top-line data readout in the second half of 2021.
- The Company recently announced that it had entered into a private placement agreement to sell Entasis common stock and warrant securities to a subsidiary of
Innoviva, Inc.(Nasdaq: INVA) ("Innoviva"), Entasis’ largest shareholder. The gross proceeds to the Company from the transaction after both closings are expected to be approximately $20 million, before deducting estimated offering expenses payable by the Company. The closing of the first tranche of the financing, consisting of approximately $7.5 million, occurred on May 3, 2021. The closing of the second tranche, consisting of approximately $12.5 million, is expected to occur in early June, assuming approval of the financing at a special meeting of stockholders. The Company intends to use the net proceeds for the continued support of the ongoing ATTACK trial, NDA filing preparation as well as working capital and other general corporate purposes.
- As of
May 1, 2021, 167 patients have been enrolled in the ATTACK trial across approximately 90 clinical trial sites in 17 countries, including China. ATTACK is our single Phase 3 registrational trial that will evaluate SUL-DUR in patients with confirmed carbapenem-resistant Acinetobacter pneumonia and/or bloodstream infections. Entasis currently estimates the trial is approximately 90% enrolled, as microbiological analyses have confirmed 108 carbapenem-resistant evaluable patients out of the target of 120 evaluable patients necessary for completion of the trial, with another 16 enrolled patients pending confirmation. The Company expects to complete enrollment in the ATTACK trial in the coming weeks with a top-line data readout in the second half of 2021.
- The Company continues to support the
Global Antibiotic Research and Development Partnership(GARDP), and the Phase 3 registration trial of zoliflodacin for the treatment of uncomplicated gonorrhea. The trial, designed to assess the safety and efficacy of oral zoliflodacin versus the current standard of care combination of intramuscular ceftriaxone plus oral azithromycin, is actively enrolling patients with uncomplicated gonorrhea, including infections potentially caused by multidrug-resistant strains of N. gonorrhoeae. In Q1, GARDP activated additional clinical trial sites in the US, Thailand, and South Africa, and plans to activate up to 16 additional clinical trial sites across these countries and the Netherlandsduring the first half of 2021. Due to the unique challenges to site activation and enrollment precipitated by the COVID-19 pandemic, the Company remains unable to provide guidance for completion of the trial. The Company will continue to monitor and consult with GARDP and will provide updates on guidance when appropriate.
First Quarter 2021 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 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
Investor Relations Contacts
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended
|Research and development||$||9,370||$||11,623|
|General and administrative||3,307||3,780|
|Total operating expenses||12,677||15,403|
|Loss from operations||(12,677||)||(15,403||)|
|Total other income||1,976||137|
|Net loss per share—basic and diluted||$||(0.29||)||$||(1.15||)|
|Weighted average common stock outstanding—basic and diluted||37,078,478||13,291,563|
|Condensed Consolidated Balance Sheets|
|Cash and cash equivalents||$||44,937||$||53,247|
|Total stockholders' equity||44,257||52,289|
|Total liabilities and stockholders’ equity||$||52,825||$||61,558|
Source: Entasis Therapeutics Holdings Inc.