Entasis Therapeutics Reports Third Quarter 2019 Financial Results and Provides Business Update
“We are extremely pleased by the continued progress we have made advancing our pipeline during the third quarter of 2019,” stated Manos Perros, President and Chief Executive Officer of
Dr. Perros added, “We also strengthened our company with the additions of Dr.
Third Quarter and Recent Highlights
- In September, the
Global Antibiotic Research and Development Partnership(GARDP) initiated the global Phase 3 pivotal trial of zoliflodacin for the treatment of uncomplicated gonorrhea. The randomized, open label trial will enroll approximately 1,000 adults with urogenital gonorrhea at clinical trial sites in the United Statesand internationally and will assess the safety and efficacy of zoliflodacin versus the combination of azithromycin and ceftriaxone, the current standard of care. Our partner GARDP is fully funding and sponsoring the trial, and in return we have provided them with exclusive commercial rights in low to select middle income countries. A data readout from the Phase 3 pivotal trial is expected in 2021.
- Entasis strengthened its board of directors through the addition of industry veteran
Howard Mayer, M.D. Dr. Mayer has held positions in executive management at both mid-sized and large pharmaceutical companies including Pfizer, Bristol-Myers Squibb, Merck KGaAand Shire Plc, and brings a wealth of experience leading and executing clinical programs, including programs in the infectious disease space.
- In November,
David Altarac, M.D., MPA joined the Company as Chief Medical Officer, concurrent with the retirement of Dr. Robin Isaacswho has served as the Company’s Chief Medical Officer since July 2015. Dr. Altarac is a recognized industry R&D leader and brings broad experience from previous roles, most recently as senior vice president and head of global regulatory affairs, global drug safety and R&D quality and compliance at Shire Plc.
- At IDWeek 2019, the Company highlighted the latest advancements in the antibacterial activity of our lead candidate SUL-DUR through two poster presentations. For the first time, the Company described the robust in vitro and in vivo antibacterial activity of SUL-DUR against Burkholderia species, a challenging group of pathogens that have the potential to cause serious respiratory infections, especially in patients with cystic fibrosis. Dr. Perros, President and CEO, also participated in an industry panel discussion on how to reinvigorate antibiotic development in the current market environment. The Company hosted an advisory panel on SUL-DUR and discussed aspects of the pivotal ATTACK clinical trial and SUL-DUR’s potential for the treatment of multidrug-resistant Acinetobacter infections.
- The Company bolstered its liquidity by entering into a Common Stock Purchase Agreement with
Aspire Capital Fund, LLC. Under the agreement, the Company may issue and sell shares of its common stock having an aggregate gross sales price of up to $20.0 million. The Company has the sole discretion to present Aspire with a purchase notice directing Aspire to purchase up to 50,000 shares of common stock per business day.
Third Quarter 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), and ETX0282CPDP (targeting Enterobacteriaceae infections). Entasis is also using its platform to develop a novel class of antibiotics, non-β-lactam inhibitors of the penicillin-binding proteins (NBPs) (targeting Gram-negative 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
(Financial Tables Follow)
|Entasis Therapeutics Holdings Inc.|
|Consolidated Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended September 30,||Nine Months Ended September 30,|
|Research and development||7,606||8,086||29,286||26,115|
|General and administrative||3,521||2,075||10,130||7,840|
|Total operating expenses||11,127||10,161||39,416||33,955|
|Loss from operations||(4,127||)||(10,161||)||(32,416||)||(28,955||)|
|Total other income||966||1,688||3,075||4,554|
|Loss before income taxes||(3,161||)||(8,473||)||(29,341||)||(24,401||)|
|Provision for income taxes||324||-||467||472|
|Net loss attributable to common stockholders—basic and diluted||$||(3,485||)||$||(17,615||)||$||(29,808||)||$||(34,015||)|
|Net loss per share—basic and diluted||$||(0.27||)||$||(20.33||)||$||(2.27||)||$||(113.22||)|
|Weighted average common stock outstanding—basic and diluted||13,134,538||866,641||13,130,837||300,435|
|Entasis Therapeutics Holdings Inc.|
|Condensed Consolidated Balance Sheets|
|September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||48,810||$||85,092|
|Total stockholders' equity||54,894||82,883|
|Total liabilities and stockholders’ equity||$||63,287||$||89,274|
Source: Entasis Therapeutics Holdings Inc.