ETTX Entasis Therapeutics Holdings Inc.

3
+0.13  (+5%)
Previous Close 2.87
Open 2.84
52 Week Low 1.75
52 Week High 9.25
Market Cap $81,874,689
Shares 27,291,563
Float 19,885,087
Enterprise Value $52,577,785
Volume 55,022
Av. Daily Volume 236,245
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Upcoming Catalysts

Drug Stage Catalyst Date
Zoliflodacin
Uncomplicated gonorrhea
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
ETX2514SUL (ATTACK)
Acinetobacter baumannii infections
Phase 3
Phase 3
Phase 3 top-line data timeline unsure due to COVID-19.
ETX0282CPDP
Complicated urinary tract infections (cUTI)
Phase 1
Phase 1
Phase 3 top-line data timeline unsure due to COVID-19.

Latest News

  1. WALTHAM, Mass., Aug. 06, 2020 (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 second quarter 2020 financial results and provided a business update.

    "I'm pleased to report substantial progress across a number of areas of the Company in the second quarter of 2020 despite significant adjustments to adapt our clinical trial operations to the COVID-19 pandemic restrictions," commented Manos Perros, President and Chief Executive Officer of Entasis Therapeutics.  "First, our two ongoing Phase 3 registration trials addressing carbapenem-resistant Acinetobacter infections and uncomplicated…

    WALTHAM, Mass., Aug. 06, 2020 (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 second quarter 2020 financial results and provided a business update.

    "I'm pleased to report substantial progress across a number of areas of the Company in the second quarter of 2020 despite significant adjustments to adapt our clinical trial operations to the COVID-19 pandemic restrictions," commented Manos Perros, President and Chief Executive Officer of Entasis Therapeutics.  "First, our two ongoing Phase 3 registration trials addressing carbapenem-resistant Acinetobacter infections and uncomplicated gonorrhea due to Neisseria gonorrhea, two "CDC urgent threats," continue to make progress in enrolling patients. Each trial, however, has been impacted by the COVID-19 pandemic as it disrupts healthcare facilities and practitioners around the world.  As a result of the unpredictability of these disruptions, at this time we cannot provide specific guidance when each trial will be completed."

    "Second, we have strengthened our balance sheet by completing the closing of the $35 million common stock and warrant investment from Innoviva, Inc., which strategically positions us to fund the ATTACK Phase 3 registration trial and advance our pipeline. Third, we secured two non-dilutive funding awards to support our pipeline of novel antibacterial programs. We are pleased to continue our relationship with CARB-X, which, in June, exercised a new option award under our existing arrangement that will support development of ETX0462 to Phase 1-ready status. ETX0462 is being developed to potentially address multidrug-resistant Pseudomonas infections.  Additionally, we have been awarded a contract from the National Institute of Allergy and Infectious Diseases (NIAID) that included an initial amount of approximately $3 million and the potential to receive up to $15.5 million. We believe this contract further validates the potential of our NBP platform to yield novel molecules with expanded Gram-negative spectrum against antibiotic-resistant bacterial pathogens. Finally, seven articles were published across our clinical programs SUL-DUR, zoliflodacin, and ETX0282CPDP, including a zoliflodacin article that was chosen as the Editors' Choice in the May 12, 2020 edition of ACS Infectious Disease. Taken together, these accomplishments provide us with momentum to continue executing on our business objectives in the second half of 2020."

    Second Quarter 2020 and Recent Highlights

    Business Highlights

    • In June, the Company closed its securities purchase agreement with Innoviva for gross proceeds of $35 million. The stock purchase occurred in two tranches. The first tranche was closed in April for an aggregate purchase price of approximately $3.3 million. In the second tranche, which was completed in June, Innoviva purchased 12,677,490 shares of common stock and warrants for gross proceeds of approximately $31.7 million.



    • In June the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria, exercised a new option under our existing arrangement.  The option provides non-dilutive support for additional pre-clinical work to further develop ETX0462, our first product candidate from our non-β-lactam inhibitor (NBP) platform, to Phase 1-ready status. 



    • In June, the Company also received a contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The contract initiated on July 1, 2020 and included an initial award of approximately $3 million, with the potential to increase up to $15.5 million. Proceeds from the contract will be used to develop novel molecules from Entasis' non-β-lactam inhibitor (NBP) platform with expanded antimicrobial spectrum.



    • In June, the Company presented at the BMO virtual 2020 Prescriptions for Success Healthcare Conference.

    SUL-DUR

    • The Company continues to advance ATTACK, a global two-part Phase 3 registration trial evaluating SUL-DUR for the treatment of patients with pneumonia and bloodstream infections caused by carbapenem-resistant Acinetobacter baumannii. The trial has now opened approximately 89 clinical sites across 16 countries, and a July 2020 Drug and Safety Monitoring Board review recommended continuation of the trial without protocol modification. Despite the continued progress, the COVID-19 pandemic continues to intermittently disrupt the operations of the ATTACK global clinical trial sites. The timing, scope and duration of these interruptions are unpredictable and, as a consequence, we cannot accurately assess their impact on the expected timeline for completion of the trial.  Therefore, the Company is suspending guidance on top-line data from this study. We will continue to monitor the situation and provide updates as available.



    • A publication from the Company (Seifert H., et al. Antimicrob Chemother. 2020 Jun 9) and a separate publication from our partner Zai Lab (Yang Q., et al. Antimicrob Chemother. 2020 Jul 1;75(7)) highlighted the in vitro potency of SUL-DUR against global isolates of carbapenem-resistant Acinetobacter baumannii and clinical isolates of Acinetobacter baumannii from China, respectively. In addition, the Company also published Phase 1 results demonstrating that durlobactam was generally safe and well tolerated when administered either alone or in combination with sulbactam and/or imipenem-cilastatin (Lickliter JD, Lawrence K, O'Donnell J, Isaacs R. Antimicrob Agents Chemother. 2020 Jun 23;64(7)).

    Zoliflodacin

    • The Company is continuing to support the Phase 3 registration trial of zoliflodacin for the treatment of uncomplicated gonorrhea in partnership with the Global Antibiotic Research and Development Partnership (GARDP). The trial is set to enroll approximately 1,000 patients with urogenital gonorrhea at clinical trial sites in the United States and around the world and will assess the safety and efficacy of zoliflodacin versus the combination of azithromycin and ceftriaxone, the current standard of care. In late-March, GARDP, with the Company's agreement, made the decision to temporarily suspend patient enrollment into the Phase 3 registration trial at U.S. sites and activation of new clinical trial sites in ex-U.S. regions due to the COVID-19 pandemic. Although patient enrollment and other trial activities resumed in July 2020, the Company is suspending guidance on the timing of the Phase 3 data readout while it continues to assess the potential impact of the COVID-19 pandemic on the global clinical trial sites and patient enrollment.



    • The Company published a review of zoliflodacin's full range of in vitro antibacterial activity against Neisseria gonorrhea, as well as Chlamydia trachomatis, Mycoplasma genitalium, Staphylococcus aureus (both methicillin-susceptible and methicillin-resistant), and Streptococcus spp. and reviewed the current state of clinical development. The publication was selected as ACS Infectious Disease Editors' Choice (Bradford PA, Miller AA, O'Donnell J, Mueller JP. ACS Infect Dis. 2020 Jun 12;6(6)).

    ETX0282CPDP

    • Following completion of initial Phase 1 studies, the Company proceeded with development of an extended release formulation aiming to optimize the safety and projected efficacy of the combination product. Having achieved preclinical proof-of-concept, the Company is now progressing with development of an appropriate clinical formulation to be initially evaluated in a Phase 1 clinical trial before progressing to clinical studies in patients.



    • The Company had three articles published on its novel oral product candidate ETX0282CPDP.  The initial discovery of ETX0282, a novel orally available β-lactamase inhibitor with broad spectrum activity was described (Durand-Reville TF, et al. .J Med Chem. 2020 Jul 13). Additionally, the Company had two ETX0282 publications highlighted in the ACS Infectious Diseases "Special issue on Antibiotics."  From in vitro, in vivo, and PK/PD analyses, the orally available combination of ETX0282 and cefpodoxime-proxetil exhibited favorable attributes for the potential treatment of ESBL- and carbapenemase-producing uropathogens or Enterabacterales (O'Donnell J, et al. ACS Infect Dis. 2020 Jun 12;6(6):1378-1388 and Miller AA, et al. ACS Infect Dis. 2020 Jun 12;6(6):1389-1397).

    Second Quarter 2020 Financial Results

    The Company reported a net loss of $13.4 million for the quarter ended June 30, 2020, which is consistent with a net loss of $13.4 million for the quarter ended June 30, 2019.

    Research and development expenses were $10.2 million for the quarter ended June 30, 2020, compared to $10.7 million for the quarter ended June 30, 2019. The decrease of $0.5 million was primarily due to decreases in spending related to our SUL-DUR product candidate and were partially offset by an increase in personnel expenses associated with higher headcount, salaries and stock-based compensation expense.

    General and administrative expenses were $3.2 million for the quarter ended June 30, 2020, compared to $3.4 million for the quarter ended June 30, 2019. The decrease of $0.2 million was driven primarily by a decrease in legal and consulting expenses and were partially offset by an increase in personnel expenses associated with higher headcount.

    As of June 30, 2020, cash, cash equivalents and short-term investments were $50.8 million, compared to $27.5 million as of March 31, 2020 . In April, the Company also entered into an agreement with Innoviva Inc. for the private placement of $35 million. 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 into the second quarter of 2021.

    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' 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 the impact of the COVID-19 pandemic, 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

    Investor Relations Contacts

    James Salierno

    The Ruth Group

    (646) 536-7028

    Media Contact

    Kirsten Thomas

    The Ruth Group

    (508) 280-6592

     
    (Financial Tables Follow)
     
    Entasis Therapeutics Holdings Inc.
    Condensed Consolidated Statements of Operations
    Unaudited
    (in thousands, except share and per share data)
                
      Three Months Ended June 30,

     Six Months Ended June 30,
      2020  2019  2020  2019
                
    Operating expenses:           
    Research and development$10,239  $10,677  $21,862  $21,679 
    General and administrative 3,241   3,421   7,021   6,609 
    Total operating expenses 13,480   14,098   28,883   28,288 
    Loss from operations (13,480)  (14,098)  (28,883) -(28,288)
    Other income:           
    Grant income 48   372   62   1,201 
    Interest income 36   417   159   908 
    Total other income 84   789   221   2,109 
    Loss before income taxes (13,396)  (13,309)  (28,662)  (26,179)
    Provision for income taxes -   73   -   144 
    Net loss$(13,396) $(13,382) $(28,662) $(26,323)
    Net loss per share—basic and diluted$(0.78) $(1.02) $(1.89) $(2.00)
    Weighted average common stock outstanding—basic and diluted 17,095,140   13,131,291   15,193,351   13,128,956 
                



    Entasis Therapeutics Holdings Inc.
    Condensed Consolidated Balance Sheets
    Unaudited
    (in thousands)
            
     June 30,

     December 31,

     2020

     2019

            
    Cash, cash equivalents and investments$50,771  $40,996 
    Other assets 5,693   10,038 
    Total assets$56,464  $51,034 
            
    Total liabilities$7,177  $8,877 
    Total stockholders' equity 49,287   42,157 
    Total liabilities and stockholders' equity$56,464  $51,034 
            

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  2. WALTHAM, Mass., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (NASDAQ:ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, today announced that Dr. Manos Perros, President and Chief Executive Officer of the Company, will present virtually at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11th at 11:30am ET and at the Canaccord Genuity 40th Annual Growth Conference on Wednesday, August 12th at 9:00am ET.

    2020 Wedbush PacGrow Healthcare Virtual Conference: 
    Date:Tuesday, August 11th, 2020
    Location:https://wsw.com/webcast/wedbush36/ettx/2269191
    Time:11:30 AM ET
      
    Canaccord Genuity 40th Annual Growth Conference:
    Date:Wednesday,

    WALTHAM, Mass., Aug. 05, 2020 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (NASDAQ:ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, today announced that Dr. Manos Perros, President and Chief Executive Officer of the Company, will present virtually at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11th at 11:30am ET and at the Canaccord Genuity 40th Annual Growth Conference on Wednesday, August 12th at 9:00am ET.

    2020 Wedbush PacGrow Healthcare Virtual Conference: 

    Date:Tuesday, August 11th, 2020
    Location:https://wsw.com/webcast/wedbush36/ettx/2269191
    Time:11:30 AM ET
      
    Canaccord Genuity 40th Annual Growth Conference:

    Date:Wednesday, August 12th, 2020
    Time:9:00 AM ET



    A replay of the Wedbush presentation will be available on the Company's website for 90 days following the event. Additionally, Dr. Perros and Dr. Michael Gutch, Chief Financial and Chief Business Officer, will hold 1-on-1 virtual investor meetings at the conferences. Investors attending the conferences virtually who are interested in meeting with Company management should contact their Wedbush and Canaccord representatives.

    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' 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.

    Entasis Company Contact    

    Kyle Dow

    Entasis Therapeutics

    (781) 810-0114

    Investor Relations Contacts

    James Salierno

    The Ruth Group

    (646) 536-7028

    Media Contact

    Kirsten Thomas

    The Ruth Group

    (508) 280-6592

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    • Royalties increased by 7% to $72.4 million in the second quarter of 2020, compared to the same quarter in 2019.
    • Pavel Raifeld named as Chief Executive Officer.
    • Invested $35 million into common stock and warrants of Entasis Therapeutics Holding Inc. (NASDAQ:ETTX), a leader in anti-infectives development.

    Innoviva, Inc. (NASDAQ:INVA) (the Company) today reported financial results for the second quarter ended June 30, 2020.

    • Gross royalty revenues of $72.4 million from Glaxo Group Limited ("GSK") for the second quarter of 2020 included royalties of $45.6 million from global net sales of RELVAR®/BREO® ELLIPTA®, royalties of $11.2 million from global net sales of ANORO® ELLIPTA® and royalties of $15.6 million from global net sales of TRELEGY…
    • Royalties increased by 7% to $72.4 million in the second quarter of 2020, compared to the same quarter in 2019.
    • Pavel Raifeld named as Chief Executive Officer.
    • Invested $35 million into common stock and warrants of Entasis Therapeutics Holding Inc. (NASDAQ:ETTX), a leader in anti-infectives development.

    Innoviva, Inc. (NASDAQ:INVA) (the Company) today reported financial results for the second quarter ended June 30, 2020.

    • Gross royalty revenues of $72.4 million from Glaxo Group Limited ("GSK") for the second quarter of 2020 included royalties of $45.6 million from global net sales of RELVAR®/BREO® ELLIPTA®, royalties of $11.2 million from global net sales of ANORO® ELLIPTA® and royalties of $15.6 million from global net sales of TRELEGY® ELLIPTA®.1
    • Changes in fair values of equity investments of $46.7 million reflected the unrealized gains of $13.4 million related to our investment in Armata Pharmaceuticals Inc. and $33.3 million related to our investment in Entasis Therapeutics Holdings, Inc.
    • Income before income taxes increased by 109% to $118.1 million, compared to the same quarter in 2019.
    • Net cash and cash equivalents, short-term investments and marketable securities, excluding $4.9 million cash balance attributable to a variable interest entity, totaled $412.2 million, and receivables from GSK totaled $82.4 million, as of June 30, 2020.

    Pavel Raifeld, Chief Executive Officer, stated: "RELVAR®/BREO® ELLIPTA® global net sales decreased by 3% compared to the second quarter of 2019. U.S. net sales decreased by 11% as continued volume growth was more than offset by greater price discounting in the ICS/LABA sector. Non-U.S. sales increased by 2%, driven by sales growth in certain European markets, Japan and Canada.

    ANORO® ELLIPTA® global net sales increased by 5% in the second quarter of 2020 compared to the second quarter of the prior year. U.S. net sales increased by 7% due to significant volume growth, despite pricing pressure stemming from channel mix shift. Non-U.S. ANORO® ELLIPTA® net sales increased 2%, supported by growth in certain European markets. In addition, TRELEGY® ELLIPTA® global net sales were $240.5 million, compared to $151.4 million during comparable period a year ago.

    While the ultimate COVID-19 impact remains uncertain, we have seen signs of normalization over the past quarter. We were pleased with the meaningful volume growth across the portfolio, despite the challenging environment and certain pandemic-related stockpiling earlier in the year," continued Mr. Raifeld.

    Mr. Raifeld concluded, "After spending several weeks at Innoviva, I am even more excited about the potential for significant shareholder value creation. Capital allocation and cost discipline remain our key priorities, and we expect to continue to opportunistically invest in promising, differentiated assets, such as those developed by Armata and Entasis, that address significant unmet medical needs and offer attractive return profiles."

    Recent Highlights

    • GSK Net Sales:
      • Second quarter 2020 net sales of RELVAR®/BREO® ELLIPTA® by GSK were $303.8 million, down 3% from $313.9 million in the second quarter of 2019, with $103.3 million in net sales from the U.S. market and $200.5 million from non-U.S. markets.
      • Second quarter 2020 net sales of ANORO® ELLIPTA® by GSK were $172.3 million, up 5% from $163.6 million in the second quarter of 2019, with $109.8 million net sales from the U.S. market and $62.5 million from non-U.S. markets.
      • Second quarter 2020 net sales of TRELEGY® ELLIPTA® by GSK were $240.5 million, up significantly from $151.4 million in the second quarter of 2019, with $174.8 million in net sales from the U.S. market and $65.7 million in net sales from non-U.S. markets.
    • Capital Allocation:
      • During the second quarter of 2020, the Company invested $35.0 million in 14.0 million shares of common stock of Entasis Therapetutics, Inc., a company focused on development of novel anti-bacterial therapies for multi-drug resistant Gram-negative bacteria, which pose well acknowledged public health risk and a rapidly growing medical need, and warrants to purchase up to an additional 14.0 million shares of the common stock at $2.50 per share. With this initial investment, Innoviva owned approximately 51% of Entasis's common stock as of June 30, 2020. Innoviva has a right to designate two members to Entasis's board.

    1 For TRELEGY ® ELLIPTA®, Innoviva is entitled to 15% of royalty payments made by GSK that are assigned to TRC, LLC.

    About Innoviva

    Innoviva, Inc. (referred to as "Innoviva", the "Company", or "we" and other similar pronouns), is a company with a portfolio of royalties that include respiratory assets partnered with Glaxo Group Limited ("GSK"), including RELVAR®/BREO® ELLIPTA® (fluticasone furoate/ vilanterol, "FF/VI"), ANORO® ELLIPTA® (umeclidinium bromide/ vilanterol, "UMEC/VI") and TRELEGY® ELLIPTA® (the combination FF/UMEC/VI). Under the Long-Acting Beta2 Agonist ("LABA") Collaboration Agreement, Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva is also entitled to 15% of royalty payments made by GSK under its agreements originally entered into with us, and since assigned to Theravance Respiratory Company, LLC ("TRC"), relating to TRELEGY® ELLIPTA® and any other product or combination of products that may be discovered and developed in the future under the LABA Collaboration Agreement and the Strategic Alliance Agreement with GSK (referred to herein as the "GSK Agreements"), which have been assigned to TRC other than RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®.

    ANORO®, RELVAR®, BREO®, TRELEGY® and ELLIPTA® are trademarks of the GlaxoSmithKline group of companies.

    Forward Looking Statements

    This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. The words "anticipate", "expect", "goal", "intend", "objective", "opportunity", "plan", "potential", "target" and similar expressions are intended to identify such forward-looking statements. Such forward-looking statements involve substantial risks, uncertainties and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to known and unknown risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: expected cost savings; lower than expected future royalty revenue from respiratory products partnered with GSK; the commercialization of RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and TRELEGY® ELLIPTA® in the jurisdictions in which these products have been approved; the strategies, plans and objectives of Innoviva (including Innoviva's growth strategy and corporate development initiatives beyond the existing respiratory portfolio); the timing, manner, and amount of potential capital returns to shareholders; the status and timing of clinical studies, data analysis and communication of results; the potential benefits and mechanisms of action of product candidates; expectations for product candidates through development and commercialization; the timing of regulatory approval of product candidates; and projections of revenue, expenses and other financial items; the impact of the novel coronavirus ("COVID-19"). Other risks affecting Innoviva are described under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" contained in Innoviva's Annual Report on Form 10-K for the year ended December 31, 2019 and Quarterly Reports on Form 10-Q, which are on file with the Securities and Exchange Commission ("SEC") and available on the SEC's website at www.sec.gov. Past performance is not necessarily indicative of future results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

    INNOVIVA, INC.
    Condensed Consolidated Statements of Income
    (in thousands, except per share data)
    (Unaudited)
     
    Three Months Ended Six Months Ended
    June 30, June 30,

    2020

    2019

    2020

    2019

    Revenue:
    Royalty revenue from a related party, net (1)

    $

    68,946

     

    $

    64,107

     

    $

    147,624

     

    $

    119,290

     

    Revenue from collaborative arrangements with a related party

     

    10,000

     

    -

     

     

    10,000

     

    -

     

    Total net revenue

     

    78,946

     

     

    64,107

     

    157,624

     

    119,290

     

     
    Operating expenses:
    Research and development

     

    559

     

    -

     

    559

     

     

    -

     

    General and administrative

    2,596

     

    4,347

     

    5,159

     

    7,362

     

    Total operating expenses

     

    3,155

     

     

    4,347

     

    5,718

     

    7,362

     

     
    Income from operations

    75,791

     

    59,760

     

    151,906

     

    111,928

     

     
    Other income (expense), net

     

    30

     

    (8

    )

    98

     

    (7

    )

    Interest income

    158

     

     

    1,403

     

    1,460

     

    2,378

     

    Interest expense

    (4,561

    )

    (4,661

    )

    (9,077

    )

    (9,278

    )

    Changes in fair values of equity investments

     

    46,698

     

    -

     

    68,613

     

    -

     

    Income before income taxes

     

    118,116

     

    56,494

     

    213,000

     

    105,021

     

    Income tax expense, net

     

    19,891

     

    10,433

     

    35,823

     

    18,941

     

    Net income

    98,225

     

     

    46,061

     

    177,177

     

     

    86,080

     

    Net income attributable to noncontrolling interest

    21,381

     

    8,321

     

    34,896

     

     

    14,550

     

    Net income attributable to Innoviva stockholders

    $

    76,844

     

    $

    37,740

     

    $

    142,281

     

    $

    71,530

     

     
    Basic net income per share attributable to Innoviva stockholders

    $

    0.76

     

    $

    0.37

     

    $

    1.40

     

    $

    0.71

     

    Diluted net income per share attributable to Innoviva stockholders

    $

    0.69

     

    $

    0.34

     

    $

    1.27

     

    $

    0.65

     

     
    Shares used to compute basic net income per share

    101,324

     

     

    101,151

     

     

    101,280

     

     

    101,105

     

    Shares used to compute diluted net income per share

    113,545

     

    113,391

     

     

    113,527

     

    113,384

     

    (1) Total net revenue from a related party is comprised of the following (in thousands):
     
    Three Months Ended Six Months Ended
    June 30, June 30,

    2020

    2019

    2020

    2019

    (unaudited) (unaudited)
     
    Royalties from a related party

    $

    72,402

     

    $

    67,563

     

    $

    154,536

     

    $

    126,202

     

    Amortization of capitalized fees paid to a related party

     

    (3,456

    )

    (3,456

    )

     

    (6,912

    )

     

    (6,912

    )

    Royalty revenue from a related party, net

    $

    68,946

     

    $

    64,107

     

    $

    147,624

     

    $

    119,290

     

    INNOVIVA, INC.
    Condensed Consolidated Balance Sheets
    (in thousands)
     
    June 30, December 31,

    2020

    2019

    (unaudited)

    (1)

     
    Assets
    Cash, cash equivalents and marketable securities

    $

    417,146

    $

    350,845

    Other current assets

    83,047

    80,389

    Property and equipment, net

     

    37

    33

    Equity investments

    128,613

    -

    Capitalized fees paid to a related party, net

    132,164

    139,076

    Deferred tax assets, net

    118,348

    154,171

    Other assets

    264

    312

    Total assets

    $

    879,619

    $

    724,826

     
     
    Liabilities and stockholders' equity
    Other current liabilities

    $

    1,262

    $

    1,219

    Accrued interest payable

    4,152

    4,152

    Convertible subordinated notes, net

    239,499

    239,217

    Convertible senior notes, net

    141,731

    137,903

    Other long-term liabilities

    163

    219

     
    Innoviva stockholders' equity

    456,907

    313,495

    Noncontrolling interest

    35,905

    28,621

     
    Total liabilities and stockholders' equity

    $

    879,619

    $

    724,826

    (1) The selected consolidated balance sheet amounts at December 31, 2019 are derived from audited financial statements.

    INNOVIVA, INC.
    Cash Flows Summary
    (in thousands)
     
     
    Six Months Ended June 30,

    2020

    2019

    (unaudited)
    Net cash provided by operating activities

    $

    153,275

     

    $

    133,151

     

    Net cash provided by (used in) investing activities

    9,044

     

    (54,060

    )

    Net cash provided by (used in) financing activities

    (27,268

    )

    444

     

     

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  3. WALTHAM, Mass., July 06, 2020 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (NASDAQ:ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, today announced it has entered into a contract with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The initial award of approximately $3 million, with the potential to increase up to $15.5 million, will be used to develop novel molecules from its non-β-lactam inhibitor (NBP) platform with expanded antimicrobial spectrum.

    "We are extremely pleased that NIAID has awarded Entasis this contract that will help further expand the scope of our NBP program," commented…

    WALTHAM, Mass., July 06, 2020 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (NASDAQ:ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, today announced it has entered into a contract with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The initial award of approximately $3 million, with the potential to increase up to $15.5 million, will be used to develop novel molecules from its non-β-lactam inhibitor (NBP) platform with expanded antimicrobial spectrum.

    "We are extremely pleased that NIAID has awarded Entasis this contract that will help further expand the scope of our NBP program," commented Dr. Ruben Tommasi, Chief Scientific Officer of Entasis Therapeutics. "This funding validates the pre-clinical safety and efficacy data demonstrated by our lead NBP candidate, ETX0462, in both in vivo and in vitro models against drug-resistant Pseudomonas aeruginosa infections, and the potential of the NBP platform to deliver additional molecules with expanded antimicrobial spectrum. We look forward to pursuing development of additional candidates from this novel class of Gram-negative antibiotics."

    Funding from the contract will support research towards developing molecules with expanded Gram-negative spectrum against antibiotic resistant bacterial pathogens including E. coli, Acinetobacter, Pseudomonas and Klebsiella. Subject to achieving pre-defined milestones, the contract will fund work up to IND-ready stage. National Institutes of Health, National Institute of Allergy and Infectious Diseases contract 75N93020C00017.

    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' 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.

    Entasis Company Contact    

    Kyle Dow

    Entasis Therapeutics

    (781) 810-0114

    Investor Relations Contacts

    Tram Bui / James Salierno

    The Ruth Group

    (646) 536-7035 / 7028



    Media Contact

    Kirsten Thomas

    The Ruth Group

    (508) 280-6592

    Primary Logo

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  4. WALTHAM, Mass., June 18, 2020 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (NASDAQ:ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, today announced that Dr. Manos Perros, President and Chief Executive Officer of the Company, will participate in a fireside chat at the BMO 2020 Prescriptions for Success Healthcare Conference being held virtually on June 23, 2020.

    Details of the fireside chat are below:
    Event:  BMO 2020 Prescriptions for Success Healthcare Conference
    Date:  Tuesday, June 23, 2020
    Location:  https://bmo.qumucloud.com/view/2020-healthcare-entasis-therapeutics
    Time:  3:30 PM ET

    Additionally, Dr. Perros will hold 1-on-1 virtual investor meetings at…

    WALTHAM, Mass., June 18, 2020 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (NASDAQ:ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, today announced that Dr. Manos Perros, President and Chief Executive Officer of the Company, will participate in a fireside chat at the BMO 2020 Prescriptions for Success Healthcare Conference being held virtually on June 23, 2020.

    Details of the fireside chat are below:

    Event:  BMO 2020 Prescriptions for Success Healthcare Conference

    Date:  Tuesday, June 23, 2020

    Location:  https://bmo.qumucloud.com/view/2020-healthcare-entasis-therapeutics

    Time:  3:30 PM ET

    Additionally, Dr. Perros will hold 1-on-1 virtual investor meetings at the conference. Investors attending the conference virtually who are interested in meeting with Company management should contact their BMO representatives.

    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' 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.

    Entasis Company Contact    

    Kyle Dow

    Entasis Therapeutics

    (781) 810-0114

    Investor Relations Contacts

    Tram Bui / James Salierno

    The Ruth Group

    (646) 536-7035 / 7028



    Media Contact

    Kirsten Thomas

    The Ruth Group

    (508) 280-6592

     

    Primary Logo

    View Full Article Hide Full Article
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