CDTX Cidara Therapeutics Inc.

2.13
-0.04  -2%
Previous Close 2.17
Open 2.24
52 Week Low 1.3
52 Week High 4.45
Market Cap $93,587,680
Shares 43,937,878
Float 38,333,894
Enterprise Value $66,139,255
Volume 351,238
Av. Daily Volume 234,149
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Upcoming Catalysts

Drug Stage Catalyst Date
Rezafungin (CD101) ReSTORE
Candidemia
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Rezafungin (CD101) ReSPECT
Prophylaxis
Phase 3
Phase 3
Phase 3 dosing of first patient announced May 20, 2020.
Rezafungin (CD101) STRIVE B
Candidemia
Phase 2
Phase 2
Phase 2 data released July 29, 2019 - noted all objectives met.
CD101 Topical - RADIANT
Vulvovaginal candidiasis (VVC)
Phase 2
Phase 2
Phase 2 data released February 21, 2017 - efficacy not evident, Development to be discontinued.

Latest News

  1. SAN DIEGO, Dec. 01, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections, today announced a keynote lecture, an oral presentation and two posters at the 7th European Scientific Working Group on Influenza (ESWI) Influenza Conference, which takes place virtually Dec. 6-9, 2020.

    The Keynote Lecture highlights Cidara's Cloudbreak antiviral platform, specifically its program for universal protection from influenza. Details of the Keynote Lecture are as follows:

    Keynote Lecture Programme:
    Title: Beyond Vaccines and mAbs: Progress Towards Universal Influenza Protection with

    SAN DIEGO, Dec. 01, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections, today announced a keynote lecture, an oral presentation and two posters at the 7th European Scientific Working Group on Influenza (ESWI) Influenza Conference, which takes place virtually Dec. 6-9, 2020.

    The Keynote Lecture highlights Cidara's Cloudbreak antiviral platform, specifically its program for universal protection from influenza. Details of the Keynote Lecture are as follows:

    Keynote Lecture Programme:
    Title: Beyond Vaccines and mAbs: Progress Towards Universal Influenza Protection with Cloudbreak® Influenza Antiviral Conjugates (AVCs)
    Speakers: Opening Remarks: Michael Ison, M.D., M.S., professor, Northwestern University Feinberg School of Medicine
      Keynote Lecture: Les Tari, Ph.D., senior vice president, research, Cidara Therapeutics
    Date and Time: Monday, Dec. 7, 2020 at 6:00 p.m. CET

    The oral and poster presentations highlight preclinical data from the antiviral conjugate (AVC) candidate, CD377 for prevention and treatment of influenza. Details of the presentations are as follows:

    Oral Presentation:
    Title: Characterization of In Vitro Activity and In Vivo Efficacy of CD377, a Novel Anti-Viral Fc-Conjugate, Against 2020-2021 Northern Hemisphere Influenza Quadrivalent Vaccine Strains
    Presenter: Jeffrey B. Locke, Ph.D., director, microbiology, Cidara Therapeutics
    Date and Time: Dec. 8, 2020 at 2:00 p.m. CET
    Session: Antiviral and immune therapy for influenza, RSV disease and COVID-19
       
    Poster Presentations:
    Title: In Vitro Potency and In Vivo Efficacy of CD377, a Novel Antiviral Fc-Conjugate, Against Highly Pathogenic Avian Influenza (HPAI)
    Presenter: James Levin, Ph.D., senior director of preclinical development, Cidara Therapeutics
    Format: On-demand
       
    Title: CD377, a Novel Antiviral Fc-Conjugate, is Equipotent by Different Dosing Routes and Active Against Oseltamivir-Resistant Isolates Of Influenza A (H1N1) in Lethal Mouse Infection Models
    Presenter: James Levin, Ph.D., senior director of preclinical development, Cidara Therapeutics
    Format: On-demand

    The Keynote Lecture and copies of the abstracts will be made available on the Publications section of the Cidara website.

    About Cloudbreak AVCs

    Cidara is developing a new generation of immunotherapeutic antivirals from its Cloudbreak antiviral platform that couple potent antivirals to a human antibody fragment. These long-acting, antiviral conjugates (AVCs) directly inhibit viral proliferation while simultaneously engaging the immune system. AVCs are initially being studied for the prevention and treatment of seasonal and pandemic influenza, with the potential to deliver universal protection for an entire flu season with a single dose. Cidara is also advancing preclinical and discovery AVC programs to target other life-threatening viruses, such as RSV, HIV and CoV, including COVID-19.

    About Cidara Therapeutics

    Cidara is developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections. The Company's portfolio is comprised of its lead antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases from Cidara's proprietary Cloudbreak® antiviral platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

    INVESTOR CONTACT:

    Brian Ritchie

    LifeSci Advisors

    (212) 915-2578

    MEDIA CONTACT:

    Karen O'Shea, Ph.D.

    LifeSci Communications

    (929) 469-3860



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  2. SAN DIEGO, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections, today announced that it will present three posters at European Society of Intensive Care Medicine (ESICM) LIVES 2020, which takes place virtually Dec. 6-9, 2020.

    Cidara will highlight analyses from the completed Phase 2 STRIVE trial of rezafungin for treatment of candidemia and/or invasive candidiasis. Rezafungin is a novel once-weekly echinocandin currently in pivotal Phase 3 trials for the treatment and prevention of serious fungal infections. New findings from the STRIVE trial related to intensive…

    SAN DIEGO, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections, today announced that it will present three posters at European Society of Intensive Care Medicine (ESICM) LIVES 2020, which takes place virtually Dec. 6-9, 2020.

    Cidara will highlight analyses from the completed Phase 2 STRIVE trial of rezafungin for treatment of candidemia and/or invasive candidiasis. Rezafungin is a novel once-weekly echinocandin currently in pivotal Phase 3 trials for the treatment and prevention of serious fungal infections. New findings from the STRIVE trial related to intensive care unit (ICU) status will be shared in the poster presentation as follows:

    Title: Analysis of the STRIVE Phase 2 Trial of Once-Weekly Rezafungin for Treatment of Candidemia and Invasive Candidiasis Compared with Caspofungin: Outcomes by ICU Status and APACHE II Score

    Presenter: P. Honoré, CHU Brugmann, Brussels

    Session: Infections and Prevention

    Format: On-demand

    Additional analyses from the STRIVE trial related to geographic region of enrollment and body mass index will be presented. Details are as follows:

    Title: Analysis of Outcomes by Geographic Region of Enrollment in STRIVE, the Phase 2 of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis (IC)

    Presenter: P. Honoré, CHU Brugmann, Brussels

    Session: Infections and Prevention

    Format: On-demand

    Title: Analysis of the STRIVE Phase 2 Trial of Once-Weekly Rezafungin for Treatment of Candidemia and Invasive Candidiasis Compared with Caspofungin: Outcomes by Body Mass Index (BMI)

    Presenter: P. Honoré, CHU Brugmann, Brussels 

    Session: Infections and Prevention

    Format: On-demand

    Copies of the posters will be made available on the Publications section of the Cidara website. Additional details can be found in the Abstract Book from ESICM LIVES 2020.

    About Rezafungin

    Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis. The structure and properties of rezafungin are specifically designed to improve upon a clinically validated mechanism intended to enhance its efficacy and safety potential for patients. Cidara is currently conducting a Phase 3 clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial) and a second Phase 3 clinical trial of once-weekly rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial).

    About Cidara Therapeutics

    Cidara is developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections. The Company's portfolio is comprised of its lead antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases from Cidara's proprietary Cloudbreak® antiviral platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

    INVESTOR CONTACT:

    Brian Ritchie

    LifeSci Advisors

    (212) 915-2578

    MEDIA CONTACT:

    Karen O'Shea, Ph.D.

    LifeSci Communications

    (929) 469-3860



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  3. SAN DIEGO, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections, today announced that it has been named a Top Workplace by The San Diego Union-Tribune for the fourth consecutive year. Cidara ranked among the top 20 small companies and was the only listed biotech therapeutics company among all three categories for large, mid-side and small companies in the San Diego Metro Area.

    "We are honored to be highlighted as one of the best places to work in the San Diego Metro Area for the fourth consecutive year," said Jeffrey Stein, Ph.D., president and chief executive…

    SAN DIEGO, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections, today announced that it has been named a Top Workplace by The San Diego Union-Tribune for the fourth consecutive year. Cidara ranked among the top 20 small companies and was the only listed biotech therapeutics company among all three categories for large, mid-side and small companies in the San Diego Metro Area.

    "We are honored to be highlighted as one of the best places to work in the San Diego Metro Area for the fourth consecutive year," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Our commitment to the development of long-acting therapeutics for serious infections has been especially critical this year in the face of the COVID-19 pandemic, and our dedicated team is essential to our efforts. We prioritize cultivating a culture that encourages our employees to collaborate, share new ideas and take ownership of their roles in the success of the Company. All members of the Cidara team share this recognition and we will continue to build, sustain and invest in our core values to lead the science of protection."

    Top Workplace lists are based solely on employee feedback gathered through a third-party survey administered by Energage, LLC, a leading provider of technology-based employee engagement tools. The anonymous survey measures several aspects of workplace culture, including alignment, execution and connection. According to Energage, 97 percent of Cidara employees participated in the 2020 survey.

    The San Diego Union-Tribune published the complete list of 2020 Top Workplaces on Sunday, November 15, 2020. The list of winners is available at: https://www.sandiegouniontribune.com/twp/story/2020-11-15/winners-of-the-2020-top-workplaces-survey

    About Cidara Therapeutics

    Cidara is developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections. The Company's portfolio is comprised of its lead antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases from Cidara's proprietary Cloudbreak® antiviral platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

    INVESTOR CONTACT:

    Brian Ritchie

    LifeSci Advisors

    (212) 915-2578

     

    MEDIA CONTACT:

    Karen O'Shea, Ph.D.

    LifeSci Communications

    (929) 469-3860

     



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  4. SAN DIEGO, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections, today announced that Jeffrey Stein, Ph.D., President and Chief Executive Officer, will participate in two upcoming conferences: the Stifel 2020 Virtual Healthcare Conference and 3rd Annual Evercore ISI HealthCONx Conference.

    Stifel 2020 Virtual Health Conference

    Date:Tuesday, November 17, 2020
    Time:2:00 PM Eastern Time
    Format:Presentation

    A live audio webcast of the presentation will be available in the Investors section on the Company's website at www.cidara.com.

    3rd Annual Evercore ISI HealthCONx

    SAN DIEGO, Nov. 11, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections, today announced that Jeffrey Stein, Ph.D., President and Chief Executive Officer, will participate in two upcoming conferences: the Stifel 2020 Virtual Healthcare Conference and 3rd Annual Evercore ISI HealthCONx Conference.

    Stifel 2020 Virtual Health Conference

    Date:Tuesday, November 17, 2020
    Time:2:00 PM Eastern Time
    Format:Presentation

    A live audio webcast of the presentation will be available in the Investors section on the Company's website at www.cidara.com.

    3rd Annual Evercore ISI HealthCONx Conference

    Date:Wednesday, December 2, 2020
    Time:11:20 AM Eastern Time
    Format:Panel Discussion - No Fungus Among Us: Addressing an Important Fungal Need

    About Cidara Therapeutics

    Cidara is developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections. The Company's portfolio is comprised of its lead antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases from Cidara's proprietary Cloudbreak® antiviral platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

    INVESTOR CONTACT:

    Brian Ritchie

    LifeSci Advisors

    (212) 915-2578

    MEDIA CONTACT:

    Karen O'Shea, Ph.D.

    LifeSci Communications

    (929) 469-3860

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  5. SAN DIEGO, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections, today reported financial results for the three months ended September 30, 2020, and provided an update on its corporate activities.

    "We continue to make important progress advancing rezafungin through Phase 3 clinical development. Based on current enrollment trends, we now anticipate top-line data from the ReSTORE trial by the end of 2021, although we continue to monitor the impact of the COVID-19 pandemic on enrollment in our clinical trials," said Jeffrey Stein, Ph.D., President and Chief Executive…

    SAN DIEGO, Nov. 05, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections, today reported financial results for the three months ended September 30, 2020, and provided an update on its corporate activities.

    "We continue to make important progress advancing rezafungin through Phase 3 clinical development. Based on current enrollment trends, we now anticipate top-line data from the ReSTORE trial by the end of 2021, although we continue to monitor the impact of the COVID-19 pandemic on enrollment in our clinical trials," said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara. "This quarter, we were also pleased to announce the formation of a scientific advisory board as well as the presentation of new clinical data on rezafungin and preclinical data on our Cloudbreak influenza program."

    Recent Corporate Highlights

    ● Strengthened expertise in viral and fungal infections and hematology through formation of scientific advisory board: In July, Cidara announced the formation of a scientific advisory board. The board consists of:

    ○ Frederick G. Hayden, MD, FACP, Stuart S. Richardson Professor Emeritus of Clinical Virology at University of Virginia School of Medicine; Professor Emeritus of Medicine at University of Virginia, Charlottesville, VA,

    ○ Michael G. Ison, MD, MS, FIDSA, FAST, Professor, Divisions of Infectious Diseases and Organ Transplantation at Northwestern University Feinberg School of Medicine; Medical Director, Transplant & Immunocompromised Host Infectious Diseases Service at Northwestern University Comprehensive Transplant Center, Chicago, IL,

    ○ Johan A Maertens, MD, PhD, FECCM, Professor of Internal Medicine and Hematology, Acute Leukemia and Transplantation Unit at University Hospitals Leuven; Department of Microbiology, Immunology and Transplantation at KULeuven, Leuven, Belgium, and

    ○ Kieren Marr, MD, MBA, Professor of Medicine and Oncology Director, Transplant and Oncology Infectious Diseases Program and Vice Chair for Innovation in Healthcare Implementation, Department of Medicine at Johns Hopkins University School of Medicine, Baltimore, MD.

    These globally recognized key opinion leaders were recruited to help advise on the direction and design of the company's development programs with an emphasis on the continued development and expansion of the company's Cloudbreak Antiviral Conjugate (AVC) program.

    ● Presented new clinical and preclinical data for rezafungin and influenza AVCs at IDWeek 2020: In October, Cidara presented two oral abstracts and seven posters at IDWeek 2020, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS) and the Society of Infectious Diseases Pharmacists (SIDP).

    ● Presented clinical and preclinical data for rezafungin at the 2020 American College of Clinical Pharmacy (ACCP) Annual Meeting: In October, Cidara presented two posters at the 2020 ACCP Annual Meeting.

    ● Participated in multiple investor conferences: Cidara recently participated in B. Riley FBR's Virtual Summer Series panel on antiviral therapeutics, Citi's 15th Annual BioPharma Conference and the Maxim Conference: "A Too Quiet Pandemic – Fungal Disease." The company also recently presented at the 2020 Wedbush PacGrow Healthcare Virtual Conference, the H.C. Wainwright 22nd Annual Global Investment Conference and the Cantor Fitzgerald Virtual Global Healthcare Conference.

    Third Quarter 2020 Financial Results

    ● Cash, cash equivalents and restricted cash totaled $53.7 million as of September 30, 2020, compared with $60.3 million as of December 31, 2019.

    ● As of September 30, 2020, Cidara had 43,936,026 shares of common stock outstanding, and 1,044,278 shares of Series X convertible preferred stock outstanding, which are convertible into 10,442,780 shares of common stock.

    ● Revenue totaled $2.4 million and $8.3 million for the three and nine months ended September 30, 2020, compared with $19.1 million for the same periods in 2019. Revenue for the three and nine months ended September 30, 2019 included $17.9 million of revenue recognized upon transfer of an intellectual property license to Mundipharma. The remaining revenue for all periods relates to ongoing research and development and clinical supply services provided to Mundipharma.

    ● Research and development expenses were $16.3 million and $46.9 million for the three and nine months ended September 30, 2020, respectively, compared to $11.5 million and $34.9 million for the same periods in 2019. The increase in research and development expenses is primarily due to higher clinical expenses associated with the rezafungin clinical trials and increased spend on our Cloudbreak antiviral platform.

    ● General and administrative expenses were $3.7 million and $11.8 million for the three and nine months ended September 30, 2020, respectively, compared to $4.6 million and $11.8 million for the same periods in 2019. The decrease in general and administrative expenses is primarily due to lower consulting and personnel related expenses.

    ● Net loss for the three months ended September 30, 2020 was $17.6 million, compared to net income of $3.0 million for the same period in 2019. For the nine months ended September 30, 2020 and 2019, net loss was $50.5 million and $27.1 million, respectively.

    About Cidara Therapeutics

    Cidara is developing long-acting therapeutics designed to transform the standard of care for patients facing serious fungal or viral infections. The Company's portfolio is comprised of its lead antifungal candidate, rezafungin, in addition to AVCs for the prevention and treatment of influenza and other viral diseases from Cidara's proprietary Cloudbreak® antiviral platform. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

    Forward-Looking Statements

    This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "anticipates," "expect," "may," "plan" or "will". Forward-looking statements in this release include, but are not limited to, statements related to the anticipated timing of top-line data from the ReSTORE trial. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara's clinical trials, impacts of the COVID-19 pandemic on patient enrollment or other obstacles to the development of rezafungin and advancement of Cidara's other development programs. These and other risks are identified under the caption "Risk Factors" in Cidara's most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

    INVESTOR CONTACT:

    Brian Ritchie

    LifeSci Advisors

    (212) 915-2578

    MEDIA CONTACT:

    Karen O'Shea, Ph.D.

    LifeSci Communications

    (929) 469-3860



    CIDARA THERAPEUTICS, INC.

    Condensed Consolidated Balance Sheets

      September 30, 2020 December 31, 2019
    (In thousands) (unaudited)  
    ASSETS    
    Cash, cash equivalents, and restricted cash $53,668  $60,268 
    Other current assets 6,519  5,546 
    Non-current assets 3,482  3,162 
    Total assets $63,669  $68,976 
         
    LIABILITIES AND STOCKHOLDERS' EQUITY    
    Total liabilities $34,116  $31,141 
    Stockholders' equity 29,553  37,835 
    Total liabilities and stockholders' equity $63,669  $68,976 



    CIDARA THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations (unaudited)

      Three Months Ended

    September 30,
     Nine Months Ended

    September 30,
    (In thousands, except share and per share data) 2020 2019 2020 2019
    Revenues:        
    Collaboration revenue $2,416  $19,100  $8,338  $19,100 
    Total revenues 2,416  19,100  8,338  19,100 
    Operating expenses:        
    Research and development 16,258  11,499  46,888  34,911 
    General and administrative 3,687  4,573  11,751  11,833 
    Total operating expenses 19,945  16,072  58,639  46,744 
    Income (loss) from operations (17,529) 3,028  (50,301) (27,644)
    Other income (expense):        
    Change in fair value of contingent forward purchase obligations       411 
    Interest income (expense), net (103) 11  (176) 164 
    Total other income (expense), net (103) 11  (176) 575 
    Net income (loss) and comprehensive income (loss) $(17,632) $3,039  $(50,477) $(27,069)
    Allocation of earnings to participating securities   (444)    
    Recognition of beneficial conversion feature     (2,762)  
    Net income (loss) attributable to common shareholders $(17,632) $2,595  $(53,239) $(27,069)
    Basic net earnings (loss) per common share $(0.41) $0.08  $(1.31) $(1.05)
    Diluted net earnings (loss) per common share $(0.41) $0.08  $(1.31) $(1.05)
             
    Shares used to compute basic net earnings (loss) per common share 43,208,308  33,961,117  40,685,828  25,735,134 
    Shares used to compute diluted net earnings (loss) per common share 43,208,308  39,807,138  40,685,828  25,735,134 

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