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Entasis Therapeutics Holdings Inc. (ETTX)

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Neutralpattern detected
Previous Close1.8200
Open1.9200
Bid1.8500 x 1300
Ask1.9100 x 800
Day's Range1.8100 - 1.9300
52 Week Range1.5800 - 4.2500
Volume361,856
Avg. Volume377,218
Market Cap71.076M
Beta (5Y Monthly)1.92
PE Ratio (TTM)N/A
EPS (TTM)-2.0990
Earnings DateAug 04, 2021 - Aug 09, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est6.50
  • Entasis Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update
    GlobeNewswire

    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 $20M financing – WALTHAM, Mass., May 05, 2021 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced today its first quarter 2021 financial results and provided a business update. “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 Manos Perros, President and Chief Executive Officer of Entasis Therapeutics. “We are especially encouraged by the progress achieved in ATTACK, our Phase 3 trial for multidrug-resistant Acinetobacter infections where we now have a clear line of sight to enrolling 120 evaluable patients with carbapenem-resistant infections. Given this progress, we remain confident ATTACK is on-track to complete enrollment in the coming weeks and for topline data readout during the second half of 2021. While advancing SUL-DUR remains our top-priority, we are also excited by the progression of our pipeline, including the Phase 3 trial for zoliflodacin, which we believe has the potential to provide a solution for the millions of annual cases of gonorrhea around the world. We are also pleased to recently announce the closing of the first tranche of a $20 million private placement transaction. The second tranche of the financing will occur upon shareholder approval, which is anticipated in June 2021. As a result of the first tranche of the offering, we now anticipate that our cash runway will be sufficient to fund our operations into the second quarter of 2022. 2021 is poised to be a transformative year for Entasis as we conclude our Phase 3 ATTACK registration trial and initiate preparations to become a commercial stage company.” First Quarter 2021 and Recent Highlights Business HighlightsThe 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. SUL-DUR 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. 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 EntasisEntasis 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 StatementsThis 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 U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Forward-looking statements contained in this announcement are made as of this date, and except as required by law, Entasis assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Company Contact Kyle Dow Entasis Therapeutics (781) 810-0114 kyle.dow@entasistx.com Investor Relations ContactsJames SaliernoThe Ruth Group(646) 536-7028jsalierno@theruthgroup.com Media ContactAnnika ParrishThe Ruth Group(720)-412-9042 aparrish@theruthgroup.com Entasis Therapeutics Holdings Inc.Condensed Consolidated Statements of OperationsUnaudited(in thousands, except share and per share data) Three Months Ended March 31, 2021 2020 Operating expenses: 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)Other income: Grant income 1,972 13 Interest income 4 124 Total other income 1,976 137 Net loss $(10,701) $(15,266)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 Entasis Therapeutics Holdings Inc. Condensed Consolidated Balance Sheets Unaudited (in thousands) March 31, December 31, 2021 2020 Cash and cash equivalents $44,937 $53,247 Other assets 7,888 8,311 Total assets $52,825 $61,558 Total liabilities $8,568 $9,269 Total stockholders' equity 44,257 52,289 Total liabilities and stockholders’ equity $52,825 $61,558

  • Entasis Therapeutics Completes Initial Closing of $20M Private Placement with Innoviva
    GlobeNewswire

    Entasis Therapeutics Completes Initial Closing of $20M Private Placement with Innoviva

    WALTHAM, Mass., May 03, 2021 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (Nasdaq: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced today that it has completed the initial closing of an approximately $7.5 million stock and warrant issuance to a subsidiary of Innoviva Inc. (Nasdaq: INVA) ("Innoviva"), pursuant to a securities purchase agreement signed on May 3, 2021. Upon satisfaction of certain closing conditions, including approval by Entasis stockholders, Innoviva will purchase the balance of the $20 million in Entasis common stock and warrant securities in a second closing that is anticipated later in the second quarter of 2021 (excluding the consideration payable upon exercise of warrants, if any). Entasis plans to use the proceeds from the offering to support the continued development of its novel pipeline of pathogen-targeted antibacterial product candidates and for general corporate purposes. Entasis’ pipeline includes sulbactam-durlobactam (SUL-DUR) for carbapenem-resistant Acinetobacter baumannii infections, and zoliflodacin for uncomplicated gonorrhea, including infections caused by drug-resistant strains of Neisseria gonorrhoeae. Both of these product candidates are currently being evaluated in Phase 3 registrational clinical trials. Pursuant to and subject to the terms and conditions of the securities purchase agreement and related agreements, Innoviva will purchase 10 million shares of Entasis common stock, at a price of $2.00 per share, and warrants to purchase up to 10 million additional shares of Entasis common stock, with an exercise price of $2.00 per share. The stock purchase will occur in two closings. At the initial closing, which occurred on May 3, 2021, Innoviva purchased approximately 3.7 million shares of common stock and warrants to purchase approximately 3.7 million shares of common stock for an aggregate purchase price of approximately $7.5 million. At the second closing, upon satisfaction of certain closing conditions including approval by Entasis stockholders, Innoviva will purchase approximately 6.3 million shares of common stock and warrants to purchase approximately 6.3 million shares of common stock for an aggregate purchase price of approximately $12.5 million. The transaction was approved by the Board of Directors of Entasis and the shareholders of Entasis will receive a proxy statement seeking their approval of the second closing in the coming weeks. About EntasisEntasis 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 StatementsThis 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 U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Forward-looking statements contained in this announcement are made as of this date, and except as required by law, Entasis assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Company ContactKyle Dow Entasis Therapeutics (781) 810-0114 kyle.dow@entasistx.com Investor Relations ContactsJames SaliernoThe Ruth Group(646) 536-7028jsalierno@theruthgroup.com Media ContactAnnika ParrishThe Ruth Group(720)-412-9042 aparrish@theruthgroup.com

  • Entasis Therapeutics Reports Full Year 2020 Financial Results and Provides Business Update
    GlobeNewswire

    Entasis Therapeutics Reports Full Year 2020 Financial Results and Provides Business Update

    – Phase 3 ATTACK registration trial more than three-quarters complete –– ATTACK topline data readout expected second half of 2021 –– Zoliflodacin Phase 3 trial adds clinical trial sites, continues enrollment – WALTHAM, Mass., March 23, 2021 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced today its full year 2020 financial results and provided a business update. “Thanks to the tremendous work of our teams, partners and investigators, and the support of our patients and their families, we are entering 2021 with improved momentum for our Phase 3 registration clinical trials addressing multidrug-resistant Acinetobacter infections and uncomplicated gonorrhea, despite the continued headwinds of the COVID-19 pandemic,” stated Manos Perros, President and Chief Executive Officer of Entasis Therapeutics. “Based on the encouraging progress achieved during the fourth quarter of 2020 and early 2021 in the ATTACK trial and with a better understanding of the impact of the pandemic, we are now able to provide guidance and anticipate completing enrollment in the ATTACK trial in the coming months with a top-line data readout during the second half of 2021. Also during 2020, we continued to advance our early-stage pipeline and strengthen our balance sheet through two private placement transactions. We look forward to an exciting 2021, which we believe will be a transformative year for Entasis as we conclude the ATTACK trial and prepare for a potential NDA filing and commercialization of sulbactam-durlobactam (SUL-DUR).” Fourth Quarter 2020 and Recent Highlights Business Highlights The Company saw steady enrollment in the ATTACK trial, despite recruitment headwinds caused by the COVID-19 pandemic. The Company estimates that the ATTACK trial is currently more than 75% enrolled and based on the trailing 12-month enrollment rate, anticipates completion of enrollment in the clinical trial in the coming months with a top-line data readout in the second half of 2021.In January, the Company issued a press release regarding its expanded access program (EAP), also referred to as compassionate use, for SUL-DUR, an investigational drug for U.S. patients with Acinetobacter baumannii infections, including potential carbapenem and multidrug-resistant strains. Patients co-infected with COVID-19 are eligible if the treating physician feels the risk benefit supports making SUL-DUR available. In cooperation with the FDA, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. In this circumstance, Entasis can provide a requesting physician with pre-approval access to SUL-DUR for the treatment of the physician’s patient if specific conditions are met and there is adequate availability of drug supply. SUL-DUR The Company continued enrollment of the ATTACK trial across approximately 95 clinical trial sites in 17 countries, including China. As of March 23, 2021, the ATTACK trial has randomized 160 patients and has had three pre-planned Data and Safety Monitoring Board reviews, including one most recently in February 2021. While the Company remains blinded to the clinical data, all three reviews recommended continuation of the trial without protocol modification. Entasis currently estimates completion of the ATTACK trial will require enrollment of approximately 170 patients to achieve the target of 120 evaluable patients. Based on the observed trailing 12-month enrollment rate, the Company anticipates completion of enrollment in the ATTACK trial in the coming months with top-line data readout in the second half of 2021.In February 2021, the Company published “In vitro activity and in vivo efficacy of sulbactam-durlobactam against pathogenic Burkholderia species” in Antimicrobial Agents and Chemotherapy. In addition, the Company presented four posters highlighting SUL-DUR’s potential during the virtual IDWeek 2020 held on October 21-25, 2020. The Company’s presentations highlighted findings which demonstrated activity of SUL-DUR against multidrug-resistant Acinetobacter clinical isolates from the Middle East as well as global Acinetobacter baumannii-calcoaceticus complex clinical isolates, a retrospective review of serious infections caused by carbapenem-susceptible and carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex, and in vitro intrinsic microbiological activity of durlobactam and combinations against multidrug resistant Mycobacterium abscessus. Zoliflodacin The Company continues to support its partner, the Global Antibiotic Research and Development Partnership (GARDP), and its Phase 3 registration 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 is actively enrolling patients with uncomplicated gonorrhea, including infections potentially caused by multidrug-resistant strains of N. gonorrhoeae. GARDP plans to activate up to 16 clinical trial sites across the United States, the Netherlands, South Africa and Thailand, with some additional site activations occurring in the first half of 2021. Due to the unique challenges posed by the COVID-19 pandemic to this global clinical trial, the Company remains unable to provide guidance around the timeline for completion or top-line data readout and will continue to actively assess the impact of the pandemic, in consultation with GARDP, and provide updates on guidance when appropriate.In March 2021, the Company published “Susceptibility trends of zoliflodacin against multidrug-resistant Neisseria gonorrhoeae clinical isolates in Nanjing, China (2014-2018)” in Antimicrobial Agents and Chemotherapy. The article presents data on susceptibility to zoliflodacin of 986 Neisseria gonorrhoeae isolates collected from men in Nanjing, China between 2014 and 2018. Zoliflodacin demonstrated compelling in vitro activity against these clinical isolates, including those with resistance to ciprofloxacin, azithromycin, and extended spectrum cephalosporins. Full Year 2020 Financial Results The Company reported a net loss of $50.5 million for the year ended December 31, 2020, compared to a net loss of $43.9 million for the year ended December 31, 2019. The increase in net loss was primarily related to a decrease in revenue in 2020 versus the prior year. Research and development expenses were $41.0 million for the year ended December 31, 2020, compared to $40.2 million for the year ended December 31, 2019. The increase of $0.9 million was primarily due to an increase in personnel expenses associated with higher headcount, higher salaries and higher stock-based compensation expense resulting from options and restricted stock units granted during the year ended December 31, 2020 and offset in part by a decrease in preclinical and clinical development expenses related to the advancement of our ETX0282CPDP product candidate and a decrease in clinical development expenses related to the advancement of our SUL-DUR product candidate. General and administrative expenses were $13.2 million for the year ended December 31, 2020, compared to $13.8 million for the year ended December 31, 2019. The decrease of $0.6 million was driven by a decrease in consulting expenses, VAT and other taxes, and legal expenses and were partially offset by an increase in insurance premiums and personnel expenses associated with higher headcount and higher salaries. As of December 31, 2020, cash, cash equivalents and short-term investments were $53.2 million, compared to $41.0 million as of December 31, 2019. Based on our current operating plan, we believe that our existing cash, cash equivalents and short-term investments will be sufficient to fund our operating expenses and capital expenditure requirements through the end of the first quarter of 2022. About EntasisEntasis 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 StatementsThis 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 U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Forward-looking statements contained in this announcement are made as of this date, and except as required by law, Entasis assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Company Contact Kyle Dow Entasis Therapeutics (781) 810-0114 kyle.dow@entasistx.com Investor Relations ContactsJames SaliernoThe Ruth Group(646) 536-7028jsalierno@theruthgroup.com Media ContactAnnika ParrishThe Ruth Group(720)-412-9042 aparrish@theruthgroup.com (Financial Tables Follow) Entasis Therapeutics Holdings Inc. Condensed Consolidated Statements of Operations Unaudited (in thousands, except share and per share data) Year Ended December 31, 2020 2019 Revenue $- $7,000 Operating expenses: Research and development 41,022 40,166 General and administrative 13,209 13,770 Total operating expenses 54,231 53,936 Loss from operations (54,231) (46,936) Other income: Grant income 3,562 2,300 Interest income 173 1,463 Total other income 3,735 3,763 Loss before income taxes (50,496) (43,173) Provision for income taxes - 677 Net loss $(50,496) $(43,850) Net loss per share—basic and diluted $(2.10) $(3.33) Weighted average common stock outstanding—basic and diluted 24,060,615 13,160,357 Entasis Therapeutics Holdings Inc. Condensed Consolidated Balance Sheets Unaudited (in thousands) December 31, 2020 2019 Cash, cash equivalents and investments $53,247 $40,996 Other assets 8,311 10,038 Total assets $61,558 $51,034 Total liabilities $9,269 $8,877 Total stockholders' equity 52,289 42,157 Total liabilities and stockholders’ equity $61,558 $51,034