| | 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. |
Zoliflodacin
| ● | 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 Netherlands during 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 $10.7 million for the three months ended March 31, 2021, compared to a net loss of $15.3 million for the three months ended March 31, 2020. The decrease in net loss was primarily related to a decrease in operating expenses during the first quarter of 2021 versus the prior year.
Research and development expenses were $9.4 million during the three months ended March 31, 2021, compared to $11.6 million during the three months ended March 31, 2020. The decrease of $2.3 million was primarily due to a decrease of $3.4 million in expenses related to our SUL-DUR product candidate attributable to decreases in clinical trial costs, manufacturing costs, spending related to commercial readiness and NDA support. These decreases were offset by increases in expenses related to our ETX0462 product candidate, other preclinical expenses and personnel expenses associated with higher headcount.
General and administrative expenses were $3.3 million for the three months ended March 31, 2021, compared to $3.8 million during the three months ended March 31, 2020. The decrease of $0.5 million was driven primarily by decreases in legal expenses and personnel related expenses, and was offset by an increase in insurance related costs.
As of March 31, 2021, cash and cash equivalents were $44.9 million, compared to $53.2 million as of December 31, 2020. Based on our current operating plan, we believe that our existing cash and cash equivalents, including amounts received from the first tranche of the most recent private offering, will be sufficient to fund our operating expenses and capital expenditure requirements into the second quarter of 2022.
About Entasis
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’
