1. SAN DIEGO, Jan. 05, 2021 (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 the Compensation Committee of its Board of Directors granted a stock option to purchase 115,000 shares of its common stock to a new employee, pursuant to the Cidara Therapeutics, Inc. 2020 Inducement Incentive Plan, with a grant date of December 31, 2020. The stock option has an exercise price of $2.00 per share, which is equal to the closing price of Cidara's common stock on the grant date. The shares subject to the option will vest over four years, with 25% of the shares vesting…

    SAN DIEGO, Jan. 05, 2021 (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 the Compensation Committee of its Board of Directors granted a stock option to purchase 115,000 shares of its common stock to a new employee, pursuant to the Cidara Therapeutics, Inc. 2020 Inducement Incentive Plan, with a grant date of December 31, 2020. The stock option has an exercise price of $2.00 per share, which is equal to the closing price of Cidara's common stock on the grant date. The shares subject to the option will vest over four years, with 25% of the shares vesting on the one-year anniversary of the vesting commencement date and the balance of the shares vesting in a series of 36 successive equal monthly installments thereafter, subject to continuous service through each vesting date. The stock option has a ten-year term and is subject to the terms and conditions of the company's 2020 Inducement Incentive Plan and its standard form of stock option grant agreement thereunder.

    The foregoing equity award was granted as an inducement material to the employee entering into employment with Cidara, in accordance with Nasdaq Listing Rule 5635(c)(4). The Cidara Therapeutics, Inc. 2020 Inducement Incentive Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of Cidara, or following a bona fide period of non-employment, as an inducement material to such individual's entering into employment with Cidara, pursuant to Nasdaq Listing Rule 5635(c)(4).

    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

     



    Primary Logo

    View Full Article Hide Full Article
  2. SAN DIEGO, Dec. 15, 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 the appointment of Christopher (Chris) Kurtz as executive vice president of technical operations. Mr. Kurtz brings more than 26 years of experience in global manufacturing, engineering, supply chain, CMC development and program management for drugs and devices at various stages of development.

    "We are pleased to welcome Chris to our leadership team at such a pivotal time for our antifungal and antiviral programs," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara…

    SAN DIEGO, Dec. 15, 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 the appointment of Christopher (Chris) Kurtz as executive vice president of technical operations. Mr. Kurtz brings more than 26 years of experience in global manufacturing, engineering, supply chain, CMC development and program management for drugs and devices at various stages of development.

    "We are pleased to welcome Chris to our leadership team at such a pivotal time for our antifungal and antiviral programs," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Chris's leadership and deep manufacturing expertise, delivering both biologic and small molecule drugs to market, will be invaluable as we advance rezafungin, currently in pivotal Phase 3 trials, towards filing, and advance our antiviral conjugate (AVC) influenza program to IND filing."

    Prior to joining Cidara, Mr. Kurtz served as head of commercial API manufacturing at Gilead Sciences, where he and his team played an instrumental role in the recent launches of products such as Biktarvy and Veklury (remdesivir). He previously served as vice president, for drug device industrialization at AbbVie, where he led product scale-up and industrialization projects for drug-device combinations. Prior to that, Mr. Kurtz held a number of leadership positions where he managed the development, scale-up and commercialization of drugs, biologics, medical devices and combination products at various companies, including Monsanto, Nektar Therapeutics, Alza Corporation, Alexza and Novo Nordisk. He has successfully established supply capabilities and navigated products from late-stage development through approval, launch and sustained commercialization. Mr. Kurtz holds a B.S. in chemical engineering from the University of Colorado and is a graduate of the Westinghouse S3G Nuclear Engineering Program. He is also a proud veteran of the US Navy Submarine Force.

    Mr. Kurtz commented, "Cidara's commitment to the development of novel long-acting therapeutics for serious fungal and viral infections is of vital importance now more than ever. Rezafungin has the potential to become the new standard of care for the treatment and prevention of invasive fungal infections globally, and I look forward to leveraging my manufacturing and supply chain expertise to support a successful launch in the coming years. Additionally, Cidara is leveraging its Cloudbreak platform to create a new class of long-acting antivirals in influenza, RSV and HIV, and I am very excited to work with the Cidara team to advance these programs."

    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 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.

    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 potential for rezafungin to transform the standard of care in treatment and prevention of invasive fungal infections, as well as the potential of the Cloudbreak platform to create a new class of long-acting AVCs in influenza, RSV and HIV. 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



    Primary Logo

    View Full Article Hide Full Article
  3. 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



    Primary Logo

    View Full Article Hide Full Article
  4. 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



    Primary Logo

    View Full Article Hide Full Article
  5. 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

     



    Primary Logo

    View Full Article Hide Full Article
  6. 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

    Primary Logo

    View Full Article Hide Full Article
  7. 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 

    Primary Logo

    View Full Article Hide Full Article
  8. Presentations highlight clinical and preclinical progress of long-acting drug candidates for serious fungal and viral infections

    Posters presenting new analyses from completed Phase 2 STRIVE trial support the efficacy and pharmacokinetics of once-weekly rezafungin in the treatment of candidemia and invasive candidiasis

    Oral and poster presentations highlight potential of antiviral conjugates (AVCs) for universal prevention and treatment of influenza

    SAN DIEGO, Oct. 21, 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 data from two oral abstracts and…

    Presentations highlight clinical and preclinical progress of long-acting drug candidates for serious fungal and viral infections

    Posters presenting new analyses from completed Phase 2 STRIVE trial support the efficacy and pharmacokinetics of once-weekly rezafungin in the treatment of candidemia and invasive candidiasis

    Oral and poster presentations highlight potential of antiviral conjugates (AVCs) for universal prevention and treatment of influenza

    SAN DIEGO, Oct. 21, 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 data from 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), taking place virtually Oct. 21-25, 2020.

    "We are pleased to share new clinical and preclinical data from our antifungal and antiviral programs at IDWeek 2020," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Analyses of the completed Phase 2 STRIVE trial of our novel echinocandin, rezafungin, for the treatment of candidemia and/or invasive candidiasis, adds to the body of evidence of rezafungin's efficacy, specifically against multiple Candida species and across a wide array of patient populations. From our Cloudbreak antiviral program, we are excited to present non-clinical data on our AVC candidate, CD377, supporting its development for universal influenza protection for all people, regardless of immune status."

    Five of the poster presentations report new findings on rezafungin, Cidara's novel, Phase 3, once-weekly echinocandin being developed for the treatment and prevention of serious fungal infections, and on patterns of echinocandin use. Highlights from these published abstracts are as follows:

    • Analyses from the completed Phase 2 STRIVE trial of rezafungin for treatment of candidemia and/or invasive candidiasis demonstrate rezafungin pharmacokinetics (PK) were consistent across diverse patient populations, with no meaningful differences observed across a wide range of patient factors, including sex, race, age and body weight.
    • Analysis of patient outcomes stratified by Candida species from the STRIVE trial demonstrated the efficacy of rezafungin across multiple Candida species, with similar or better outcomes observed with rezafungin compared to standard of care, caspofungin.
    • Results from an excretion balance, metabolism and PK study in healthy adults showed that fecal excretion of unmetabolized drug is the major route of elimination of rezafungin in humans, consistent with preclinical results from rats and monkeys.
    • Pharmacoepidemiologic analysis of echinocandin use during hospitalization and upon discharge, at a large, quaternary care medical center showed that a significant portion of echinocandin courses continued after hospital discharge, where a long-acting echinocandin could be of benefit.

    Two oral and two poster presentations report new findings from Cidara's Cloudbreak antiviral platform, specifically the AVC development candidate, CD377, for prevention and treatment of influenza. Data highlights from the published abstracts on CD377 are as follows:

    • A single dose of CD377 was protective against lethal challenge with a panel of seasonal and pandemic influenza subtypes in mice, demonstrating its potent broad-spectrum activity.
    • CD377 demonstrated superior dose-dependent viral load reduction in the lung compared to approved influenza treatment oseltamivir in lethal influenza mouse and ferret models.
    • Additional data in mice demonstrated the efficacy of a single dose of CD377 in both prevention and treatment of influenza infection. CD377 administered 28 days prior to infection completely protected against several strains of influenza, and treatment efficacy was observed with a single dose of CD377 72- hours-post infection. High bioavailability of CD377 (77%) was observed after subcutaneous or intramuscular administration. PK studies performed in mice, rats, ferrets and monkeys demonstrated that CD377 is stable and has a long half-life, with no adverse effects observed in a monkey toxicology study.
    • Further studies demonstrated the efficacy of CD377 in both immune-competent and immune-deficient mice lethally challenged with influenza, with similar PK and potent in vitro activity observed at equivalent doses irrespective of immune status.

    Presentation details will be accessible on the Publications section of the Cidara website at the conclusion of the conference.

    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 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.

    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 rezafungin's efficacy and potential as a once-weekly treatment and its ability to prevent severe fungal infections and disease, our Cloudbreak AVCs' potential to directly inhibit viral proliferation while simultaneously engaging the immune system, and the ability of our influenza AVC to treat and deliver universal protection for an entire flu season with a single dose. 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 or pre-clinical studies or other obstacles to the development of rezafungin or Cidara's Cloudbreak AVCs. 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

     

    Primary Logo

    View Full Article Hide Full Article
  9. SAN DIEGO, Oct. 13, 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 two posters at the 2020 American College of Clinical Pharmacy (ACCP) Annual Meeting, which takes place virtually from October 19-30, 2020. Data being presented will highlight rezafungin, the Company's novel once-weekly echinocandin currently being evaluated in pivotal Phase 3 trials for the treatment and prevention of serious fungal infections.

    Details of the poster presentations are as follows:

    Title: A Pharmacoepidemiologic Evaluation of Echinocandin Use
    Authors

    SAN DIEGO, Oct. 13, 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 two posters at the 2020 American College of Clinical Pharmacy (ACCP) Annual Meeting, which takes place virtually from October 19-30, 2020. Data being presented will highlight rezafungin, the Company's novel once-weekly echinocandin currently being evaluated in pivotal Phase 3 trials for the treatment and prevention of serious fungal infections.

    Details of the poster presentations are as follows:

    Title: A Pharmacoepidemiologic Evaluation of Echinocandin Use

    Authors: Jinhee Jo, Pharm.D., Joshua Hendrickson, Pharm.D., Anne Gonzales-Luna, Pharm.D., BCIDP, Nicholas Beyda, Pharm.D., BCPS and Kevin Garey, Pharm.D., M.S.; University of Houston

    Date and Time: Tuesday, Oct. 27, 2020 at 12:45 p.m. – 2:15 p.m. CT

    Session: Scientific Poster Session III -- Encore

    Title: Phase 2 STRIVE Clinical Trial of Rezafungin for Treatment of Candidemia and/or Invasive Candidiasis Demonstrates Consistent Trough Concentrations Across Diverse Patient Populations

    Authors: Shawn Flanagan, Ph.D., Christopher M. Rubino, Pharm.D., BCPS and Taylor Sandison, M.D., MPH; Cidara

    Date and Time: Wednesday, Oct. 28, 2020 at 4:00 p.m. – 5:30 p.m. CT

    Session: Scientific Poster Session V -- Encore

    Additional details can be found on the ACCP website and a copy of the presentation materials can be accessed on the Publications section of the Cidara website once the presentations conclude.

    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

    Primary Logo

    View Full Article Hide Full Article
  10. SAN DIEGO, Sept. 14, 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 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), which takes place virtually Oct. 21-25, 2020.

    Cidara will detail new findings related to rezafungin, its novel once-weekly echinocandin…

    SAN DIEGO, Sept. 14, 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 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), which takes place virtually Oct. 21-25, 2020.

    Cidara will detail new findings related to rezafungin, its novel once-weekly echinocandin in Phase 3 trials for the treatment and prevention of serious fungal infections, in five poster presentations. Details are as follows:

    Title: Phase 2 STRIVE Clinical Trial of Rezafungin for Treatment of Candidemia and/or Invasive Candidiasis Demonstrates Consistent Trough Concentrations Across Diverse Patient Populations

    Poster ID: 1174

    Presenter: Shawn Flanagan, Cidara 

    Date: Wednesday, Oct. 21, 2020

    Session: Medical Mycology

    Title: Outcomes by Baseline Pathogens and Susceptibility in the STRIVE Phase 2 Trial of Once-Weekly Rezafungin for Treatment of Candidemia and Invasive Candidiasis Compared with Caspofungin

    Poster ID: 1284

    Presenter: George R. Thompson III, University of California, Davis

    Date: Wednesday, Oct. 21, 2020

    Session: Novel Agents

    Title: Outcomes by Body Mass Index (BMI) in the STRIVE Phase 2 Trial of Once-Weekly Rezafungin for Treatment of Candidemia and Invasive Candidiasis Compared with Caspofungin Poster ID: 637

    Presenter: Jose A. Vazquez, Medical College of Georgia at Augusta University

    Date: Wednesday, Oct. 21, 2020

    Session: Clinical Trials

    Title: Pharmacokinetics, Excretion, and Mass Balance of [14C]-Rezafungin Following Intravenous (IV) Administration in Healthy Adults

    Poster ID: 1286

    Presenter: Voon Ong, Cidara

    Date: Wednesday, Oct. 21, 2020

    Session: Novel Agents

    Title: A Pharmacoepidemiologic Evaluation of Echinocandin Use

    Poster ID: 43

    Presenter: Jinhee Jo, University of Houston

    Date: Wednesday, Oct. 21, 2020

    Session: Poster Session: Antimicrobial Stewardship: Outcomes Assessment (clinical and economic)

    Cidara will detail new findings from its Cloudbreak antiviral platform, specifically for the prevention and treatment of influenza, in two oral and two poster presentations on the development candidate CD377. Details are as follows:

    Title: Efficacy of CD377, a Novel Antiviral Fc-Conjugate, Against Seasonal Influenza in Lethal Mouse Infection Models

    Oral Abstract ID: 159

    Presenter: James Levin, Cidara

    Format: On demand

    Session: Novel Vaccines and Antibodies

    Title: CD377, a Novel Antiviral Fc-Conjugate, Demonstrates Potent Viral Burden Reduction against Influenza A (H1N1) in Mouse and Ferret Models

    Oral Abstract ID: 162

    Presenter: Simon Döhrmann, Cidara

    Format: On demand

    Session: Novel Vaccines and Antibodies

    Title: New Generation Antiviral Conjugate (AVC): Stable, Safe, and Single

    Poster ID: 1283

    Presenter: Voon Ong, Cidara 

    Date: Wednesday, Oct. 21, 2020

    Session: Novel Agents

    Title: Evaluation of CD377, a Novel Antiviral Fc-Conjugate (AVC), In Vitro Activity and In Vivo Efficacy in Immune-Competent and -Deficient (SCID) Lethal Mouse Models

    Poster ID: 1276

    Presenter: James Levin, Cidara

    Date: Wednesday, Oct. 21, 2020

    Session: Novel Agents

    Copies of the abstracts will be made available on the Publications section of the Cidara website. Additional details can be found on the IDWeek Interactive Program Planner.

    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 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.

    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 rezafungin's potential as a once-weekly treatment and its ability to prevent severe fungal infections, and statements related to our AVCs' potential to directly inhibit viral proliferation while simultaneously engaging the immune system, and the ability of our influenza AVC to deliver universal protection for an entire flu season with a single dose. 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 or other obstacles to the development of rezafungin. 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

    Primary Logo

    View Full Article Hide Full Article
  11. SAN DIEGO, Sept. 02, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics 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 four investor conferences in September: Citi's 15th Annual BioPharma Conference, H.C. Wainwright 22nd Annual Global Investment Conference, Cantor Fitzgerald Virtual Global Healthcare Conference, and Maxim Conference: A Too Quiet Pandemic – Fungal Disease.

    Citi's 15th Annual BioPharma Conference 
    Date: Wednesday, September 9, 2020
    1x1 meetings only
       
    H.C. Wainwright 22nd Annual Global Investment Conference
    Date:

    SAN DIEGO, Sept. 02, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics 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 four investor conferences in September: Citi's 15th Annual BioPharma Conference, H.C. Wainwright 22nd Annual Global Investment Conference, Cantor Fitzgerald Virtual Global Healthcare Conference, and Maxim Conference: A Too Quiet Pandemic – Fungal Disease.

    Citi's 15th Annual BioPharma Conference 
    Date: Wednesday, September 9, 2020
    1x1 meetings only
       
    H.C. Wainwright 22nd Annual Global Investment Conference
    Date: Monday, September 14, 2020
    Time: 4:30 PM Eastern Time
       
    Cantor Fitzgerald Virtual Global Healthcare Conference
    Date: Wednesday, September 16, 2020
    Time: 3:20 PM Eastern Time
       
    Maxim Conference: A Too Quiet Pandemic – Fungal Disease
    Date: Thursday, September 17, 2020
    Time: 11:00 AM Eastern Time

    A live audio webcast and replay of the presentations at the H.C. Wainwright and Cantor Fitzgerald-sponsored events will be available in the Investors section on the Company's website at www.cidara.com.

    About Cidara Therapeutics

    Cidara is developing long-acting therapeutics to improve the standard of care for patients facing serious fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) targeting 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

    Primary Logo

    View Full Article Hide Full Article
  12. SAN DIEGO, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, today reported financial results for the three months ended June 30, 2020, and provided an update on its corporate activities and product pipeline.

    "We are pleased to have dosed the first patient in our Phase 3 ReSPECT trial, which is evaluating rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (BMT)," said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara. "BMT patients often follow complex, poorly tolerated drug…

    SAN DIEGO, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, today reported financial results for the three months ended June 30, 2020, and provided an update on its corporate activities and product pipeline.

    "We are pleased to have dosed the first patient in our Phase 3 ReSPECT trial, which is evaluating rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (BMT)," said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara. "BMT patients often follow complex, poorly tolerated drug regimens and rezafungin has the potential to simplify and significantly transform the treatment approach for both patients and providers. We were also pleased to have been recently added to the Russell 3000® Index, which we believe reflects investors' appreciation of Cidara's antifungal and antiviral development portfolio."

    Recent Corporate Highlights

    • Dosed first patient in ReSPECT trial: In May, Cidara dosed the first patient in its pivotal Phase 3 ReSPECT trial of rezafungin for the prevention of invasive fungal disease in patients undergoing BMT.

       
    • Added to Russell 3000 Index: In June, Cidara announced that it had been added to the Russell 3000® Index.

       
    • Presented at two investor conferences: In June, Cidara participated in the Cantor Fitzgerald Virtual Symposium, "Winning Ways to Treat Infections and COVID-19," and presented at the Raymond James Human Health Innovations Conference.

    Second Quarter 2020 Financial Results

    • Cash, cash equivalents and restricted cash totaled $64.1 million as of June 30, 2020, compared with $60.3 million as of December 31, 2019. 



    • As of June 30, 2020, Cidara had 42,019,195 shares of common stock outstanding, and 1,096,519 shares of Series X convertible preferred stock outstanding, which are convertible into 10,965,190 shares of common stock. 



    • Research and development expenses were $17.6 million and $30.6 million for the three and six months ended June 30, 2020, respectively, compared to $10.7 million and $23.4 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 $4.0 million and $8.1 million for the three and six months ended June 30, 2020, respectively, compared to $3.5 million and $7.3 million for the same periods in 2019. The increase in general and administrative expenses is primarily due to higher consulting expenses and legal expenses associated with securing intellectual property rights.



    • Net loss for the three months ended June 30, 2020 was $18.3 million, compared to a net loss of $13.5 million for the second quarter of 2019. For the six months ended June 30, 2020 and 2019, net loss was $32.8 million and $30.1 million, respectively.

    About Cidara Therapeutics

    Cidara is developing long-acting therapeutics to improve the standard of care for patients facing serious fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead antifungal candidate, rezafungin, in addition to Antiviral Fc-Conjugates (AVCs) targeting 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 rezafungin's ability to simplify and transform the standard of care for patients facing serious fungal or viral infections, whether rezafungin will simplify and transform the treatment for patients undergoing allogeneic BMT, the ability of our rezafungin and Cloudbreak antiviral programs to address the ongoing COVID-19 pandemic and whether our inclusion in the Russell 3000 index will result in increased visibility to institutional investors. You are cautioned that 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, including the availability of, and participation in, financing opportunities. These and other risks are identified in our filings with the Securities and Exchange Commission ("SEC"), including without limitation our most recent Quarterly Report on Form 10-Q and other filings subsequently made by Cidara with the SEC. 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

     June 30, 2020 December 31, 2019
    (In thousands)(unaudited)  
    ASSETS   
    Cash, cash equivalents, and restricted cash$64,085  $60,268 
    Other current assets5,954  5,546 
    Non-current assets3,364  3,162 
    Total assets$73,403  $68,976 
        
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Total liabilities$32,051  $31,141 
    Stockholders' equity41,352  37,835 
    Total liabilities and stockholders' equity$73,403  $68,976 



    CIDARA THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations (unaudited)

     Three Months Ended

    June 30,
     Six Months Ended

    June 30,
    (In thousands, except share and per share data)2020 2019 2020 2019
    Revenues:       
    Collaboration revenue$3,392  $  $5,922  $ 
    Total revenues3,392    5,922   
    Operating expenses:       
    Research and development17,634  10,743  30,630  23,412 
    General and administrative3,969  3,525  8,064  7,260 
    Total operating expenses21,603  14,268  38,694  30,672 
    Loss from operations(18,211) (14,268) (32,772) (30,672)
    Other income (expense):       
    Change in fair value of contingent forward purchase obligations  681    411 
    Interest (expense) income, net(95) 40  (73) 153 
    Total other (expense) income, net(95) 721  (73) 564 
    Net loss and comprehensive loss$(18,306) $(13,547) $(32,845) $(30,108)
    Recognition of beneficial conversion feature    (2,762)  
    Net loss attributable to common shareholders$(18,306) $(13,547) $(35,607) $(30,108)
    Basic and diluted net loss per common share$(0.45) $(0.47) $(0.90) $(1.19)
            
    Shares used to compute basic and diluted net loss per common share40,965,180  28,590,651  39,410,751  25,248,314 

     

    Primary Logo

    View Full Article Hide Full Article
  13. SAN DIEGO, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics 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 present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11, 2020.

    Presentation Information:
    Date:Tuesday, August 11, 2020
    Time:3:30 PM ET
    Webcast:A live audio webcast and replay of the presentation will be available in the Investors section on the Company's website at www.cidara.com.

    About Cidara Therapeutics
    Cidara is developing long-acting therapeutics to improve the standard of care for patients…

    SAN DIEGO, Aug. 04, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics 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 present at the 2020 Wedbush PacGrow Healthcare Virtual Conference on Tuesday, August 11, 2020.

    Presentation Information:
    Date:Tuesday, August 11, 2020
    Time:3:30 PM ET
    Webcast:A live audio webcast and replay of the presentation will be available in the Investors section on the Company's website at www.cidara.com.

    About Cidara Therapeutics

    Cidara is developing long-acting therapeutics to improve the standard of care for patients facing serious fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) targeting 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

     

    Primary Logo

    View Full Article Hide Full Article
  14. SAN DIEGO, July 27, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, today announced the formation of a scientific advisory board (SAB) and the appointment of four leading experts in viral and fungal infections and hematology. The SAB will work closely with the Cidara management team to help guide 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.

    "We are proud to have globally recognized key opinion leaders in virology, fungal diseases, transplant…

    SAN DIEGO, July 27, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, today announced the formation of a scientific advisory board (SAB) and the appointment of four leading experts in viral and fungal infections and hematology. The SAB will work closely with the Cidara management team to help guide 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.

    "We are proud to have globally recognized key opinion leaders in virology, fungal diseases, transplant and hematology joining our newly formed SAB," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "The SAB members' collective expertise aligns with the advancement of our Cloudbreak antiviral conjugates into respiratory viruses such as influenza, RSV and coronavirus as well as with potential additional applications of rezafungin for the prevention of fungal infections in patients with hematologic malignancies and for Covid Associated Pulmonary Aspergillosis (CAPA)."

    Cidara Therapeutics' SAB is comprised 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

       
    • 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

    About Cidara Therapeutics

    Cidara is developing long-acting therapeutics to improve the standard of care for patients facing serious fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) targeting 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

    Primary Logo

    View Full Article Hide Full Article
  15. SAN DIEGO, July 17, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics 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 the B. Riley FBR Virtual Summer Series panel on antiviral therapeutics on Tuesday, July 21, 2020.

    Presentation Information:
    Panel:  Antiviral Therapeutics
    Date:  Tuesday, July 21, 2020
    Time:  1:00 PM ET / 10:00 AM PT

    If you are an institutional investor and would like to register to participate in this event, please contact Brian Ritchie of LifeSci Advisors at .

    About Cidara Therapeutics

    SAN DIEGO, July 17, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics 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 the B. Riley FBR Virtual Summer Series panel on antiviral therapeutics on Tuesday, July 21, 2020.

    Presentation Information:
    Panel:  Antiviral Therapeutics
    Date:  Tuesday, July 21, 2020
    Time:  1:00 PM ET / 10:00 AM PT

    If you are an institutional investor and would like to register to participate in this event, please contact Brian Ritchie of LifeSci Advisors at .

    About Cidara Therapeutics

    Cidara is developing therapeutics to improve the standard of care for patients facing severe fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead antifungal candidate, rezafungin, in addition to therapies targeting 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

     

    Primary Logo

    View Full Article Hide Full Article
  16. SAN DIEGO, June 29, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, today announced that it has been added to the Russell 3000® Index at the conclusion of the Russell indexes annual reconstitution, effective upon the U.S. market open today, June 29, 2020.

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's U.S. indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

    "We are pleased…

    SAN DIEGO, June 29, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, today announced that it has been added to the Russell 3000® Index at the conclusion of the Russell indexes annual reconstitution, effective upon the U.S. market open today, June 29, 2020.

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's U.S. indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

    "We are pleased to be included in the Russell 3000 index and view this important milestone as validation of the progress we've achieved in communicating the value of our antifungal and antiviral programs to the investment community," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Moreover, we believe our inclusion in the Russell 3000 has the potential to further enhance shareholder value through increased institutional investor exposure and visibility for Cidara."

    For more information on the Russell 3000 and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.

    About Cidara Therapeutics

    Cidara is developing therapeutics to improve the standard of care for patients facing serious fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead antifungal candidate, rezafungin, in addition to therapies targeting 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 whether our inclusion in the Russell 3000 index will result in improved shareholder value. You are cautioned that 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, including the availability of, and participation in, financing opportunities. These and other risks are identified in our filings with the SEC, including without limitation our most recent Quarterly Report on Form 10-Q and in other filings subsequently made by Cidara with the SEC. 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

    Primary Logo

    View Full Article Hide Full Article
  17. SAN DIEGO, June 23, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics 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 the Cantor Fitzgerald "Winning Ways to Treat Infections and COVID-19" Virtual Symposium on Tuesday, June 30, 2020.

    The discussion is intended to provide important updates on how innovative companies, such as Cidara, are leveraging their proprietary technology platforms to develop new ways to treat infections, including COVID diseases. The panelists will also discuss how COVID-19 underscores the need for stockpiling…

    SAN DIEGO, June 23, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics 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 the Cantor Fitzgerald "Winning Ways to Treat Infections and COVID-19" Virtual Symposium on Tuesday, June 30, 2020.

    The discussion is intended to provide important updates on how innovative companies, such as Cidara, are leveraging their proprietary technology platforms to develop new ways to treat infections, including COVID diseases. The panelists will also discuss how COVID-19 underscores the need for stockpiling in the U.S. The call will be moderated by Louise Chen, Senior Research Analyst and Managing Director of Cantor Fitzgerald.

    Presentation Information:

    Panel:                     "Winning Ways to Treat Infections and COVID-19"

    Date:                       Tuesday, June 30, 2020

    Time:                      11:00 AM ET

    To register, please click here.

    About Cidara Therapeutics

    Cidara is developing therapeutics to improve the standard of care for patients facing severe fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead antifungal candidate, rezafungin, in addition to therapies targeting 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 whether Cidara will be able to successfully leverage its proprietary Cloudbreak® antiviral platform to develop new ways to treat infections, including COVID diseases.  You are cautioned that 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, including the availability of, and participation in, financing opportunities. These and other risks are identified in our filings with the SEC, including without limitation our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and in other filings subsequently made by Cidara with the SEC. 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

     

    Primary Logo

    View Full Article Hide Full Article
  18. SAN DIEGO, June 11, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics 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 present virtually at the Raymond James Human Health Innovations Conference on Thursday, June 18, 2020.

    Presentation Information:
    Date: Thursday, June 18, 2020
    Time: 3:40 PM ET
    Webcast: A live audio webcast and replay of the presentation will be available in the Investors section on the Company's website at www.cidara.com.

    About Cidara Therapeutics
    Cidara is developing therapeutics to improve the standard of care for patients facing…

    SAN DIEGO, June 11, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics 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 present virtually at the Raymond James Human Health Innovations Conference on Thursday, June 18, 2020.

    Presentation Information:

    Date: Thursday, June 18, 2020
    Time: 3:40 PM ET
    Webcast: A live audio webcast and replay of the presentation will be available in the Investors section on the Company's website at www.cidara.com.

    About Cidara Therapeutics

    Cidara is developing therapeutics to improve the standard of care for patients facing serious fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) targeting 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

     

    Primary Logo

    View Full Article Hide Full Article
  19. SAN DIEGO and CAMBRIDGE, England, May 20, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, and Mundipharma today announced that the first patient has been dosed in its ReSPECT pivotal Phase 3 clinical trial evaluating the efficacy and safety of the company's lead antifungal candidate, rezafungin, for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (BMT). Rezafungin is a novel, once-weekly echinocandin being developed for both the treatment and prevention of severe fungal infections.

    Johan A. Maertens, M.D., Ph.D., FECCM…

    SAN DIEGO and CAMBRIDGE, England, May 20, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, and Mundipharma today announced that the first patient has been dosed in its ReSPECT pivotal Phase 3 clinical trial evaluating the efficacy and safety of the company's lead antifungal candidate, rezafungin, for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (BMT). Rezafungin is a novel, once-weekly echinocandin being developed for both the treatment and prevention of severe fungal infections.

    Johan A. Maertens, M.D., Ph.D., FECCM, Professor of Internal Medicine and Hematology, University Hospitals Leuven, Leuven, Belgium and investigator in the ReSPECT study, said, "Rezafungin has the potential to become the new standard of care to prevent invasive fungal disease in patients undergoing allogeneic blood and marrow transplants. The cocktail of preventative options used today has significant limitations, such as toxicities, hazardous drug-drug interactions and patient compliance. With one drug, rezafungin, given once-weekly, we may be able to overcome these substantial limitations to improve patient outcomes in this highly immunosuppressed population."

    Jeffrey Stein, Ph.D., president and chief executive officer of Cidara, added, "The ReSPECT pivotal Phase 3 trial studying rezafungin for the prevention of severe fungal infections, along with our ongoing ReSTORE Phase 3 trial evaluating rezafungin for the treatment of invasive Candida infections, positions rezafungin to potentially become the first new antifungal approved for both the treatment and prevention of serious fungal infections in nearly 15 years. Patients with compromised immune systems face complex drug regimens when undergoing BMT and experience a high mortality rate if infected. Shifting the antifungal standard of care to a single once-weekly drug, rezafungin, which has the potential to protect against three deadly pathogens, could significantly transform the approach and outcomes for patients and health care providers alike."  

    Cidara is supported in the ongoing development of rezafungin by Mundipharma, who will be responsible for bringing the therapy to patients outside the U.S. and Japan.

    Brian Sheehan, senior vice president Innovation at Mundipharma commented: "We are pleased to be working in partnership with Cidara Therapeutics on this promising therapy in an area that has seen little innovation in over a decade. The launch of this pivotal Phase 3 trial is an important milestone in our joint efforts to support vulnerable patients around the world."

    The ReSPECT trial is a global, randomized, double-blind, controlled, pivotal Phase 3 trial of rezafungin versus the standard antimicrobial regimen to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in subjects undergoing allogeneic BMT. Rezafungin, dosed once-weekly, will be compared to a daily regimen containing multiple drugs including fluconazole or posaconazole, and trimethoprim-sulfamethoxazole, also known as Bactrim, for 90 days, at which time fungal-free survival will be measured as the primary efficacy outcome. The trial will enroll approximately 462 adults with underlying conditions, such as acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, myelodysplastic syndrome(s), lymphoma and aplastic anemia, across approximately 30 BMT centers.

    Further information on the ReSPECT trial can be found at: https://clinicaltrials.gov/ct2/show/NCT04368559

    About Invasive Fungal Disease
    Each year, an estimated 1.5 million people with compromised or suppressed immune systems die of invasive fungal infections worldwide.1 The current standard of care for the prevention of invasive fungal disease requires complex patient-specific plans and drug cocktails that are subject to change due to the underlying disease, toxicities and the local epidemiology of fungal infections.2,3 Patients who have received a blood and marrow transplant, cancer chemotherapy or solid organ transplant may receive prophylaxis to prevent deadly Candida, Aspergillus and/or Pneumocystis infections for several weeks to over a year, depending on the period of immunosuppression or development of Graft Versus Host Disease.3

    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 were specifically designed to improve upon a clinically validated mechanism, enhancing its efficacy and safety potential for patients. Cidara and its strategic partner Mundipharma are currently conducting a Phase 3 clinical trial with rezafungin for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial)4, as well as a second Phase 3 clinical trial of once-weekly rezafungin for prevention against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial).5 Mundipharma has exclusive rights to develop and commercialize rezafungin in all markets outside of the United States and Japan, which are retained by Cidara.

    About Cidara Therapeutics
    Cidara is developing therapeutics to improve the standard of care for patients facing serious fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) targeting 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.

    About the Mundipharma network
    Mundipharma is a global network of privately-owned independent associated companies whose purpose is to move medicine forward.  With a high performing and learning organisation that strives for innovation and commercial excellence through partnerships, we successfully transformed and diversified our European portfolio of medicines to create value for patients, payers and wider healthcare systems across important therapeutic areas such as Diabetes, Respiratory, Oncology, Pain and Biosimilars.

    Safe Harbor Statement
    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, whether we can successfully develop rezafungin, establish it as a new standard of care or whether rezafungin can overcome limitations of existing therapies, whether the Phase 3 development program for rezafungin will be successful and be approved both for treatment and prevention of serious fungal infections, or whether as a therapy it will protect against deadly pathogens and transform the approach and outcomes for patients and healthcare providers. Risks that contribute to the uncertain nature of the forward-looking statements include, but are not limited to: the success and timing of Cidara's clinical trials; regulatory developments in the United States and foreign countries; changes in Cidara's plans to develop and commercialize its product candidates; Cidara's ability to obtain additional financing; Cidara's ability to obtain and maintain intellectual property protection for its product candidates; the success and timing of Cidara's discovery and pre-clinical programs; the loss of key scientific or management personnel; and the impacts of global health crises, including the recent COVID-19 pandemic. These and other risks and uncertainties are described more fully in Cidara's Form 10-Q most recently filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cidara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    INVESTOR CONTACT:
    Brian Ritchie
    LifeSci Advisors
    (212) 915-2578

    MEDIA CONTACT:
    Karen O'Shea, Ph.D.
    LifeSci Communications
    (929) 469-3860

    MEDIA CONTACT: (Ex-US and Japan)
    Helen Rae
    Makara Health Communications
    +44 (0) 7503 652 311 / +44 (0) 23 81 247 327

    References:

    1. Bongomin F, Gago S, Oladele RO et al. Global and Multi-National Prevalence of Fungal Diseases-Estimate Precision. J Fungi (Basel). 2017;3(4).
    2. Vazquez L.  Antifungal Prophylaxis in Immunocompromised Patients. Mediterr J Hematol Infect Dis. 2016; 8(1): e2016040.
    3. Fleming S,  Yannakou CK,  Haeusler GM et al. Consensus guidelines for antifungal prophylaxis in haematological malignancy and haemopoietic stem cell transplantation, 2014. Internal Medicine Journal 2014; 44 (12b):1283-97.
    4. https://clinicaltrials.gov/ct2/show/NCT03667690
    5. https://clinicaltrials.gov/ct2/show/NCT04368559

    Primary Logo

    View Full Article Hide Full Article
  20. SAN DIEGO, May 13, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, today reported financial results for the three months ended March 31, 2020, and provided an update on its corporate activities and product pipeline.

    "We are pleased to report that we have recently activated our first clinical trial site for the Phase 3 ReSPECT trial, which is evaluating rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (BMT), and it is now open for enrollment," said Jeffrey Stein, Ph.D., president and chief executive officer…

    SAN DIEGO, May 13, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, today reported financial results for the three months ended March 31, 2020, and provided an update on its corporate activities and product pipeline.

    "We are pleased to report that we have recently activated our first clinical trial site for the Phase 3 ReSPECT trial, which is evaluating rezafungin for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (BMT), and it is now open for enrollment," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "In regard to our ongoing Phase 3 ReSTORE trial, which is evaluating rezafungin for the treatment of invasive Candida infections, while we are encouraged to see enrollment trends improving in certain geographies over the past few weeks, given the continued uncertainty of the impact of the COVID-19 pandemic on future enrollment, we are temporarily suspending guidance related to the anticipated timing of top-line data until we have further clarity around overall enrollment trends."

    Dr. Stein continued, "As a consequence of the current pandemic, multiple publications have reported invasive aspergillosis in up to 30% of critically ill hospitalized COVID-19 patients, and Cidara is exploring potential sources of government or other non-dilutive funding to conduct a clinical trial of rezafungin for the prevention of the hyperimmune response due to aspergillus infections in the respiratory tract of COVID-19 patients. In addition, we are currently evaluating molecules generated from our Cloudbreak® AVC antiviral platform against SARS-CoV-2 and other members of the coronavirus family."

    Recent Corporate Highlights

    • Activated first ReSPECT trial site: In May, Cidara activated the first clinical trial site in its Phase 3 ReSPECT prophylaxis trial of rezafungin in patients undergoing allogeneic blood and marrow transplant.
       
    • Completed $30M rights offering: In February, Cidara raised $30M through issuance of common and Series X Preferred stock in a rights offering that was fully backstopped by Biotechnology Value Fund, L.P. and Stonepine Capital, LP.
       
    • Announced new data for rezafungin and CD377: In May, new clinical and preclinical data were published for rezafungin and CD377, Cidara's antiviral conjugate (AVC) development candidate for influenza, via the virtual abstract book from the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).
       
    • Exploring rezafungin and Cloudbreak antiviral programs to address COVID-19 challenges: Cidara identified the potential for rezafungin, its lead antifungal candidate, to be used in the prevention of the hyperimmune response seen in critical COVID-19 patients with aspergillosis. Cidara also began evaluating AVCs identified from its Cloudbreak antiviral platform as potential coronavirus therapeutics.
       
    • Presented at two investor conferences: Cidara presented at the 19th Annual Needham Virtual Healthcare Conference in April and Maxim Group's Infectious Diseases Virtual Conference in May.

    First Quarter 2020 Financial Results

    • Cash, cash equivalents and restricted cash totaled $74.3 million as of March 31, 2020, compared with $60.3 million as of December 31, 2019. 

    • As of March 31, 2020, Cidara had 40,559,511 shares of common stock outstanding, and 1,096,519 shares of Series X convertible preferred stock outstanding, which are convertible into 10,965,190 shares of common stock. 

    • Research and development expenses were $13.0 million for the three months ended March 31, 2020, compared to $12.7 million for the same period in 2019. The increase was primarily attributable to clinical development activities for rezafungin. 

    • General and administrative expenses were $4.1 million for the three months ended March 31, 2020, compared to $3.7 million for the same period in 2019. 

    • Net loss for the three months ended March 31, 2020 was $14.5 million, compared to a net loss of $16.6 million for the first quarter of 2019.

    About the ReSPECT Clinical Trial
    The ReSPECT trial is a global, randomized, double-blind, controlled, pivotal Phase 3 trial of rezafungin versus the standard antimicrobial regimen to prevent invasive fungal disease due to Candida, Aspergillus and Pneumocystis in subjects undergoing allogeneic BMT. Using the same once weekly dosing regimen previously used in the Phase 2 and currently used in Phase 3 treatment trials with an extended duration for 90 days, Rezafungin will be compared to a daily regimen containing multiple drugs including fluconazole or posaconazole, and trimethoprim-sulfamethoxazole, also known as Bactrim, for 90 days, at which time fungal-free survival will be measured as the primary efficacy outcome. The trial will enroll approximately 462 adults with underlying conditions, such as acute myeloid leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, myelodysplastic syndrome(s), lymphoma and aplastic anemia, across approximately 30 BMT centers.

    About Cidara Therapeutics
    Cidara is developing therapeutics to improve the standard of care for patients facing severe fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead antifungal candidate, rezafungin, in addition to therapies targeting 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 whether Cidara will be able to continue to activate clinical trials sites or timely enroll the ReSPECT trial,  whether current enrollment in the ReSTORE trial represents an improved enrollment trend overall, whether the impact of the COVID-19 pandemic on the ReSTORE trial will subside and allow Cidara to predict timing for top-line data, whether rezafungin will be an effective prophylaxis against COVID-19-related fungal infections and whether Cidara will be able to attract non-dilutive financing to conduct a clinical trial for this purpose, and whether Cidara will successfully identify AVCs from its Cloudbreak antiviral platform that will be effective against COVID-19.  You are cautioned that 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, including the availability of, and participation in, financing opportunities. These and other risks are identified in our filings with the SEC, including without limitation our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and in other filings subsequently made by Cidara with the SEC. 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
      March 31, 2020   December 31, 2019
    (In thousands) (unaudited)    
    ASSETS      
    Cash, cash equivalents, and restricted cash $ 74,314   $ 60,268
    Other current assets 6,307   5,546
    Non-current assets 3,476   3,162
    Total assets $ 84,097   $ 68,976
           
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Total liabilities $ 30,345   $ 31,141
    Stockholders' equity 53,752   37,835
    Total liabilities and stockholders' equity $ 84,097   $ 68,976


    CIDARA THERAPEUTICS, INC.
    Condensed Consolidated Statements of Operations (unaudited)
      Three Months Ended
    March 31,
    (In thousands, except share and per share data) 2020   2019
    Revenues:      
    Collaboration Revenue $ 2,530     $  
    Total revenues 2,530      
    Operating expenses:      
    Research and development 12,996     12,669  
    General and administrative 4,095     3,735  
    Total operating expenses 17,091     16,404  
    Loss from operations (14,561 )   (16,404 )
    Other income (expense):      
    Change in fair value of contingent forward purchase obligations     (270 )
    Interest income, net 22     113  
    Total other income (expense) 22     (157 )
    Net loss and comprehensive loss $ (14,539 )   $ (16,561 )
    Recognition of beneficial conversion feature (2,762 )    
    Net loss attributable to common shareholders $ (17,301 )   $ (16,561 )
    Basic and diluted net loss per common share $ (0.46 )   $ (0.58 )
           
    Shares used to compute basic and diluted net loss per common share 37,856,338     28,532,176  


    Primary Logo

    View Full Article Hide Full Article
  21. Abstract Book highlights new data from Cidara accepted for presentation at ECCMID 2020

     Phase 2 trial shows superiority of rezafungin in time to clear deadly infection

    Seven abstracts highlight new data on influenza antiviral conjugates (AVCs) from Cloudbreak® antiviral platform 

    SAN DIEGO, May 05, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, today announced the publication of 10 abstracts reporting new clinical and preclinical data on the Company's antifungal rezafungin program and preclinical data on its Cloudbreak® antiviral program. The abstracts are being published…

    Abstract Book highlights new data from Cidara accepted for presentation at ECCMID 2020

     Phase 2 trial shows superiority of rezafungin in time to clear deadly infection

    Seven abstracts highlight new data on influenza antiviral conjugates (AVCs) from Cloudbreak® antiviral platform 

    SAN DIEGO, May 05, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, today announced the publication of 10 abstracts reporting new clinical and preclinical data on the Company's antifungal rezafungin program and preclinical data on its Cloudbreak® antiviral program. The abstracts are being published by the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in an online book of abstracts that had been accepted for presentations at ECCMID 2020, which was canceled due to the coronavirus global pandemic.

    "We appreciate the decision of the ECCMID 2020 organizers to publish the abstract book to communicate important scientific results at a time when our collective efforts are focused on dealing with COVID-19," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Our data accepted for ECCMID 2020 highlight critical clinical and preclinical efficacy differentiation for our programs. We also appreciate now more than ever that we need novel approaches to prevent and treat viral infections, which is the focus of our Cloudbreak antiviral platform. The seven abstracts accepted for our lead AVC, CD377, support its advancement in IND enabling studies toward our goal of providing a non-vaccine approach to universal influenza protection for all people with a single dose per flu season."

    Three of the published abstracts detail new findings related to rezafungin, Cidara's novel, Phase 3, once-weekly echinocandin being developed for the treatment and prophylaxis of invasive fungal disease. Copies of the abstracts can be accessed on the Publications section of the Cidara website. Data highlights from the published abstracts on rezafungin are as follows:

    • Analysis of the complete STRIVE Phase 2 trial (Parts A and B) results demonstrate that a single dose of rezafungin had a Day 5 success rate (resolution of clinical signs of infection + mycological eradication) of 62.3% versus 55.7% for the approved echinocandin comparator, caspofungin, dosed once-daily.  Moreover, the time to negative blood culture in the rezafungin-treated patients was statistically faster than that in caspofungin treated patients. These findings show early efficacy of rezafungin and support front-loaded plasma exposure as a pharmacometric determinant of efficacy.
    • A second analysis from Parts A and B of the STRIVE Phase 2 trial demonstrate that outcomes following treatment with rezafungin were comparable between the North American and European patients.
    • Preclinical data in a rabbit model of Candida endophthalmitis show treatment with rezafungin significantly lowered fungal burden as compared to micafungin, an echinocandin approved for the treatment of Candida infection, voriconazole, an azole for the treatment of Candida infection, and vehicle control in multiple tissues of the eye. The rezafungin treated group was the only one to demonstrate no eye lesions following treatment.

    Seven of the published abstracts detail new findings around Cidara's Cloudbreak antiviral platform candidate, CD377, for the prevention and treatment of influenza. Copies of the abstracts can be accessed on the Publications section of the Cidara website. Data highlights from the published abstracts on Cidara's lead antiviral conjugate (AVC) CD377 are as follows:

    • Preclinical in vitro and in vivo data highlight CD377's tolerability and stability. CD377 was stable and intact after incubations in mouse and human plasma and human hepatocytes. In the mouse, rat, and monkey, the half-life of CD377 was five to 10 days with high bioavailability (77%) observed after subcutaneous or intramuscular administration. A two-week toxicology study in monkeys showed no adverse effect on body weight, clinical chemistry, hematology, coagulation, cytokines or urinalysis. 
    • Single doses of CD377 in a lethal mouse model of influenza A showed a greater decrease in lung viral burden and cytokine levels compared to oseltamivir dosed for 5 days, twice daily at 10X the human equivalent dose. Treatment with one dose of CD377 two hours post-infection resulted in a dose-dependent reduction in viral burden in the lungs four days post-infection, which correlated with a dose-dependent reduction in inflammatory cytokines.
    • Additional preclinical data show that mice treated with single, low doses of CD377 are protected in lethal challenge models with several seasonal influenza subtypes. A single CD377 dose resulted in complete recovery from lethal challenge with several influenza strains.
    • CD377 fully protected immune-competent and severely immunodeficient mice with similar doses in lethal influenza challenge models. Immune-competent mice treated with CD377 fully recovered by the end of the study (day 14), while vehicle mice succumbed to infection by day 6. Varying doses of CD377 protected immune-compromised mice challenged with the same virus for the duration of the 28-day study. Immune-compromised mice treated with baloxavir reached 40% mortality after 28 days.
    • Preclinical in vitro data show lower resistance potential of CD377 compared to approved influenza treatments, baloxavir and oseltamivir, against a pandemic strain of influenza. Over the course of 10 serial passages, there was no increase in viral titer in the presence of CD377, in contrast to a 2.5 log increase in viral titer at six and eight passages with baloxavir and oseltamivir, respectively.
    • Additional preclinical in vitro data indicate that CD377 has potent, broad-spectrum antiviral activity encompassing seasonal, pandemic and drug resistant influenza A strains, as well as both lineages of influenza B. Its ability at a low dose to inhibit an essential enzyme on the surface of the influenza virus, neuraminidase, was superior to approved influenza treatments, oseltamivir and zanamivir, and comparable or superior to baloxavir.
    • CD377 also induces, as designed, a robust immune response against cells infected with multiple strains of seasonal and pandemic influenza. CD377 induced potent induction of mechanisms of cell-mediated immune defense, antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis through its Fc-mediated interaction with Fcg receptors.

    The abstract book is published online and freely accessible on ECCMID's website.

    About Rezafungin
    Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prophylaxis of severe fungal infections, such as candidemia and invasive candidiasis. The structure and properties of rezafungin were specifically designed to improve upon a clinically validated mechanism, enhancing 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). The Company is also advancing a second Phase 3 clinical trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial).

    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 replication while simultaneously engaging the immune system. AVCs are initially being studied for the prevention and treatment of the 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 additional life-threatening viruses, including HIV, parainfluenza, RSV and coronaviruses, including COVID-19.

    About Cidara Therapeutics
    Cidara is developing therapeutics to improve the standard of care for patients facing serious fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) targeting 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
    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, whether we can successfully develop rezafungin and differentiate it from existing therapies, whether we will be successful in identifying novel approaches to prevent and treat viral infections using our Cloudbreak antiviral platform, whether we will be able to continue the development of our AVCs, including CD377, and whether we will be successful in developing a product for universal single-dose influenza protection, or at all. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidara's clinical trials; regulatory developments in the United States and foreign countries; changes in Cidara's plans to develop and commercialize its product candidates; Cidara's ability to obtain additional financing; Cidara's ability to obtain and maintain intellectual property protection for its product candidates; the success and timing of Cidara's discovery and pre-clinical programs; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Cidara's Form 10-K most recently filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cidara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    INVESTOR CONTACT:
    Brian Ritchie
    LifeSci Advisors
    (212) 915-2578

    MEDIA CONTACT:
    Karen O'Shea, Ph.D.
    LifeSci Communications
    (929) 469-3860

    Primary Logo

    View Full Article Hide Full Article
  22. SAN DIEGO, April 28, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives, today announced that Jeffrey Stein, Ph.D., President and Chief Executive Officer, will participate in two panels discussing antifungal and COVID-19 therapies at the upcoming Infectious Disease Virtual Conference presented by Maxim Group.

    Presentation Information:
    Panel: "Antifungals"
    Date: Tuesday, May 5, 2020
    Time: 12:15 – 1:45 PM ET
       
    Panel: "COVID-19 (Therapeutics)"
    Date: Tuesday, May 5, 2020
    Time: 3:45 – 5:00 PM ET

    Registration for Live Event: http://go.pardot.com/l/652223/2020-04-02/j1mqg

    About Cidara Therapeutics
    Cidara is developing…

    SAN DIEGO, April 28, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives, today announced that Jeffrey Stein, Ph.D., President and Chief Executive Officer, will participate in two panels discussing antifungal and COVID-19 therapies at the upcoming Infectious Disease Virtual Conference presented by Maxim Group.

    Presentation Information:
    Panel: "Antifungals"
    Date: Tuesday, May 5, 2020
    Time: 12:15 – 1:45 PM ET
       
    Panel: "COVID-19 (Therapeutics)"
    Date: Tuesday, May 5, 2020
    Time: 3:45 – 5:00 PM ET

    Registration for Live Event: http://go.pardot.com/l/652223/2020-04-02/j1mqg

    About Cidara Therapeutics
    Cidara is developing therapeutics to improve the standard of care for patients facing severe fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead antifungal candidate, rezafungin, in addition to therapies targeting 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
    om

    MEDIA CONTACT:
    Karen O'Shea, Ph.D.
    LifeSci Communications
    (929) 469-3860

    Primary Logo

    View Full Article Hide Full Article
  23. SAN DIEGO, April 07, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives, today announced that Jeffrey Stein, Ph.D., President and Chief Executive Officer, will present at the 19th Annual Needham Virtual Healthcare Conference on Tuesday, April 14, 2020.

    Presentation Information:

    Date:                       Tuesday, April 14, 2020

    Time:                       2:50 PM ET

    Webcast:                 A live audio webcast and replay of the presentation will be available in the

    Investors section on the company's website at www.cidara.com.

    About Cidara Therapeutics

    Cidara is developing therapeutics to improve the standard of care for patients facing severe fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead antifungal candidate, rezafungin, in addition to therapies targeting influenza and other viral diseases from Cidara's proprietary Cloudbreak® 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

    Primary Logo

    View Full Article Hide Full Article
  24. SAN DIEGO, March 04, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives, reported financial results for the three months and full year ended December 31, 2019, and provided an update on its corporate activities and product pipeline.

    "2019 was a transformational year for Cidara, as we achieved multiple key corporate and clinical milestones," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "In July 2019 we released positive top line data from our STRIVE B clinical trial which was followed in September with the announcement of our partnership with Mundipharma for the ex-U.S. and…

    SAN DIEGO, March 04, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives, reported financial results for the three months and full year ended December 31, 2019, and provided an update on its corporate activities and product pipeline.

    "2019 was a transformational year for Cidara, as we achieved multiple key corporate and clinical milestones," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "In July 2019 we released positive top line data from our STRIVE B clinical trial which was followed in September with the announcement of our partnership with Mundipharma for the ex-U.S. and ex-Japan rights to rezafungin. We also announced the nomination of our Cloudbreak development candidate, CD377, which we plan to develop as the first antiviral drug conjugate (AVC) with the potential for universal, once-per-season prevention, as well as treatment of influenza. The significant momentum our business generated in 2019 continued into early 2020, as we recently raised $30 million via a rights offering that was fully backstopped by BVF Partners and Stonepine Capital. Looking ahead, we continue to enroll patients in our pivotal Phase 3 ReSTORE treatment trial and we will initiate our Phase 3 ReSPECT prophylaxis study."

    Recent Corporate Highlights

    • Raised $30 million in equity: In February 2020, Cidara closed a $30 million rights offering that was fully backstopped by BVF Partners L.P. and Stonepine Capital, LP.
    • Presented preclinical rezafungin data at TCT: In February 2020, Cidara presented preclinical data supporting rezafungin for the prevention of invasive fungal infections in patients undergoing blood and marrow transplantation at the Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation & Cellular Therapy and the Center for International Blood & Marrow Transplant Research. 
    • Highlighted new preclinical data at the 2019 ASH Annual Meeting: In December 2019, Cidara presented new preclinical data supporting the rezafungin program for the prevention of invasive fungal infections at the 61st American Society of Hematology (ASH) Annual Meeting.
    • Presented rezafungin data at the Interdisciplinary Meeting on Anti-Infective Chemotherapy: In December 2019, Cidara delivered an oral presentation providing an overview of the rezafungin clinical development program for the treatment and prevention of invasive fungal infections at the 39th Interdisciplinary Meeting on Anti-Infective Chemotherapy.

    Fourth Quarter and Full Year 2019 Financial Results

    • Revenues were $1.8 million and $20.9 million for the three months and full year ended December 31, 2019, compared to no revenue for the same periods in 2018.
    • Cash, cash equivalents, and restricted cash totaled $60.3 million at December 31, 2019, compared to $74.6 million at December 31, 2018. This does not include the $30 million raised through the rights offering completed in February 2020.
    • As of December 31, 2019, Cidara had 33,838,466 shares of common stock outstanding, 565,231 shares of Series X convertible preferred stock issued and outstanding at December 31, 2019. This does not include 6,639,307 shares of common stock and 531,288 shares of Series X convertible preferred stock issued through the rights offering completed in February 2020.
    • Research and development expenses were $11.5 million and $46.4 million for the three months and full year ended December 31, 2019, compared to $13.0 million and $49.1 million for the same periods in 2018.
    • General and administrative expenses were $4.4 million and $16.2 million for the three months and full year ended December 31, 2019, compared to $3.6 million and $14.1 million for the same periods in 2018.
    • Net loss for the three months ended December 31, 2019, was $14.0 million, compared to a net loss of $12.3 million for the fourth quarter of 2018. Net loss for the 12 months ended December 31, 2019, was $41.1 million, compared to a net loss of $59.0 million for the year ended December 31, 2018.

    About Cidara Therapeutics
    Cidara is developing therapeutics to improve the standard of care for patients with severe fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead antifungal candidate, rezafungin, in addition to therapies targeting influenza and other viral diseases from Cidara's proprietary Cloudbreak® 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 regarding whether achievement of corporate or clinical milestones in 2019 will have a positive impact on our future or be transformational to our business in the future, or whether we will commence enrollment in ReSPECT on time, or at all. You are cautioned that 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, including the availability of, and participation in, financing opportunities. These and other risks are identified in our filings with the SEC, including without limitation our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 and in other filings subsequently made by Cidara with the SEC. 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

      December 31, 2019   December 31, 2018
    (In thousands)      
    ASSETS      
    Cash, cash equivalents, and restricted cash $ 60,268     $ 74,562  
    Accounts receivable and other current assets 5,546     2,567  
    Non-current assets 3,162     1,983  
    Total assets $ 68,976     $ 79,112  
           
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Total liabilities $ 31,141     $ 19,973  
    Stockholders' equity 37,835     59,139  
    Total liabilities and stockholders' equity $ 68,976     $ 79,112  


    Cidara Therapeutics, Inc.
    Condensed Consolidated Statements of Operations

      Three months ended
    December 31,
      Year ended
    December 31,
      2019   2018   2019   2018
                   
    (In thousands, except share and per share data) (unaudited)        
    Revenues:              
    Collaboration revenue $ 1,815     $     $ 20,915     $  
    Total revenues 1,815         20,915      
    Operating expenses:              
    Research and development 11,490     13,046     46,401     49,142  
    General and administrative 4,405     3,552     16,238     14,143  
    Total operating expenses 15,895     16,598     62,639     63,285  
    Loss from operations (14,080 )   (16,598 )   (41,724 )   (63,285 )
    Other income (expense):              
    Change in fair value of contingent forward purchase obligation     4,075     411     3,851  
    Interest income (expense), net 57     182     221     629  
    Other expense     (1 )       (211 )
    Total other income (expense) 57     4,256     632     4,269  
    Net loss $ (14,023 )   (12,342 )   $ (41,092 )   $ (59,016 )
    Recognition of beneficial conversion feature             (10,329 )
    Net loss attributable to common shareholders $ (14,023 )   $ (12,342 )   $ (41,092 )   $ (69,345 )
    Basic and diluted net loss per common share $ (0.42 )   $ (0.44 )   $ (1.41 )   $ (2.76 )
    Shares used to compute basic and diluted net loss per common share 33,272,964     27,780,212     29,093,174     25,142,976  
                           

     

    Primary Logo

    View Full Article Hide Full Article
  25. SAN DIEGO, Feb. 18, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing therapeutics to improve the standard of care for patients facing severe fungal or viral infections, today announced that it will present a poster at the Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR), which takes place from Feb. 19-23, 2020, in Orlando, Florida. In addition, the Company will have an oral presentation at Mycology 2020, which takes place from Mar. 13-14, 2020, in London.

    The presentations will highlight Cidara's rezafungin program for the treatment and prophylaxis…

    SAN DIEGO, Feb. 18, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing therapeutics to improve the standard of care for patients facing severe fungal or viral infections, today announced that it will present a poster at the Transplantation & Cellular Therapy (TCT) Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR), which takes place from Feb. 19-23, 2020, in Orlando, Florida. In addition, the Company will have an oral presentation at Mycology 2020, which takes place from Mar. 13-14, 2020, in London.

    The presentations will highlight Cidara's rezafungin program for the treatment and prophylaxis of invasive fungal infections. The poster presentation at the TCT Meetings will feature preclinical data supporting rezafungin for the prevention of invasive fungal infections in patients undergoing blood and marrow transplantation, and the oral presentation at Mycology 2020 will provide an overview of clinical and preclinical data supporting the role of rezafungin for both treatment and prevention of invasive fungal infections.

    Presentation details are as follows:

    Poster Presentation at the TCT Meetings of ASTCT and CIBMTR
    Title: Rezafungin Prevention of Pneumocystis Pneumonia and Pneumocystis Reactivation
    Using Different Doses and Durations of Prophylaxis in a Mouse Model
    Session: Poster Session II
    Presenter: Voon Ong, Ph.D., Cidara Therapeutics
    Date and Time: Saturday, Feb. 22, 2020, from 6:15-7:45 p.m. EST
    Location: World Marriott Center, Orlando, Florida

    Oral Presentation at Mycology 2020
    Title: Rezafungin: a Novel, Once-Weekly Echinocandin in Phase 3 Development for Treatment and Prevention of Invasive Fungal Disease
    Presenter: Dr. Varun Mehra MBBS MRCP, consultant hematologist, Kings College Hospital
    Date and Time: Saturday, Mar. 14, 2020, from 12:45-1:00 p.m. GMT
    Location: QE 2 Conference Center, London

    Additional details can be found on the TCT Meetings website and the Mycology 2020 website. A copy of the presentation materials can be accessed on the Publications section of the Cidara website once the presentations conclude.

    About Rezafungin
    Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prophylaxis of severe fungal infections, such as candidemia and invasive candidiasis.
    The structure and mechanism of rezafungin are based on a clinically validated approach to improve the efficacy and safety potential of the drug for patients. Cidara is currently advancing rezafungin in a Phase 3 clinical trial for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE trial). The Company is also advancing a second Phase 3 trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT trial).

    About Cidara Therapeutics
    Cidara is developing therapeutics to improve the standard of care for patients with severe fungal or viral infections. The Company's portfolio is comprised of breakthrough approaches aimed at transforming existing treatment and prevention paradigms, first with its lead antifungal candidate, rezafungin, in addition to therapies targeting influenza and other viral diseases from Cidara's proprietary Cloudbreak® 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

     

    Primary Logo

    View Full Article Hide Full Article
  26. SAN DIEGO, Feb. 12, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX) ("Cidara") today announced the closing of its previously announced rights offering (the "Rights Offering"). At the closing, Cidara sold and issued an aggregate of 6,639,307 shares of its common stock (the "Common Stock") and an aggregate of 531,288 shares of its Series X convertible preferred stock ("Series X Preferred Stock"), pursuant to the exercise of subscription rights in the Rights Offering from its existing holders of Common Stock, Series X Preferred Stock and Cidara's warrants issued on May 21, 2018.  Of the total shares of Common Stock and Series X Preferred Stock sold and issued in the Rights Offering, BVF Partners L.P., a Cidara stockholder and…

    SAN DIEGO, Feb. 12, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX) ("Cidara") today announced the closing of its previously announced rights offering (the "Rights Offering"). At the closing, Cidara sold and issued an aggregate of 6,639,307 shares of its common stock (the "Common Stock") and an aggregate of 531,288 shares of its Series X convertible preferred stock ("Series X Preferred Stock"), pursuant to the exercise of subscription rights in the Rights Offering from its existing holders of Common Stock, Series X Preferred Stock and Cidara's warrants issued on May 21, 2018.  Of the total shares of Common Stock and Series X Preferred Stock sold and issued in the Rights Offering, BVF Partners L.P., a Cidara stockholder and warrant holder, purchased 587,244 shares of Common Stock and 531,288 shares of Series X Preferred Stock and Stonepine Capital, LP, a Cidara warrant holder, purchased 1,554,050 shares of Common Stock, pursuant to the exercise of their subscription and oversubscription rights. Cidara raised aggregate gross proceeds of approximately $30.0 million.

    The Rights Offering was made pursuant to Cidara's effective shelf registration statement on file with the Securities and Exchange Commission (the "SEC") (File No. 333-228268) and a prospectus supplement and accompanying prospectus filed with the SEC on January 22, 2020.

    About Cidara Therapeutics

    Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients' lives. Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE). Cidara is also advancing a second Phase 3 trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT) initially in Europe and Canada. In addition to its robust rezafungin clinical program, Cidara is applying its proprietary Cloudbreak® platform to develop antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases. The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patient's immune system to attack and eliminate pathogens. Cidara is headquartered in San Diego, California.

    INVESTOR CONTACT:
    Brian Ritchie
    LifeSci Advisors
    (212) 915-2578

    MEDIA CONTACT:
    Karen O'Shea, Ph.D.
    LifeSci Communications
    (929) 469-3860

    Primary Logo

    View Full Article Hide Full Article
  27. SAN DIEGO, Jan. 22, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX) ("Cidara") today commenced the previously announced rights offering to raise gross proceeds of approximately $30.0 million (the "Rights Offering"). Under the terms of the Rights Offering, the holders, as of 5:00 p.m., New York time, on January 21, 2020, of Cidara's common stock and Series X convertible preferred stock, and Cidara's warrants issued on May 21, 2018,  are entitled to purchase up to 11,952,191 shares of common stock in the aggregate at a subscription price equal to $2.51 per share, or under certain circumstances, shares of non-voting Series X convertible preferred stock in lieu of common stock (collectively, the "Offered Shares"), as more fully…

    SAN DIEGO, Jan. 22, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX) ("Cidara") today commenced the previously announced rights offering to raise gross proceeds of approximately $30.0 million (the "Rights Offering"). Under the terms of the Rights Offering, the holders, as of 5:00 p.m., New York time, on January 21, 2020, of Cidara's common stock and Series X convertible preferred stock, and Cidara's warrants issued on May 21, 2018,  are entitled to purchase up to 11,952,191 shares of common stock in the aggregate at a subscription price equal to $2.51 per share, or under certain circumstances, shares of non-voting Series X convertible preferred stock in lieu of common stock (collectively, the "Offered Shares"), as more fully described in the prospectus supplement, dated January 22, 2020, relating to the Rights Offering.

    The Rights Offering will be fully backstopped by BVF Partners L.P. and Stonepine Capital, LP, each of which has agreed to purchase at a minimum, its respective as-converted pro rata share of the offering amount, plus an additional amount of securities that are not subscribed for by other purchasers in the Rights Offering, for a total of up to $30.0 million. Cidara expects to use the proceeds from the Rights Offering for working capital and other general corporate purposes.

    Cidara reserves the right to modify, extend, postpone or cancel the Rights Offering at any time prior to the closing of the sale of the Offered Shares in the Rights Offering. Cidara has engaged D.F. King & Co., Inc., to act as information agent with respect to the Rights Offering. For questions regarding the Rights Offering, or to obtain copies of the Rights Offering prospectus supplement and any related materials, please contact D.F. King & Co. at or by telephone at 800-820-2415.

    Cidara has filed a shelf registration statement (including a prospectus supplement) with the Securities and Exchange Commission (the "SEC") (File No. 333-228268). Before you invest, you should read the prospectus supplement and other documents Cidara has filed with the SEC for more complete information about Cidara and the Rights Offering. This announcement shall not constitute an offer to sell, or the solicitation of an offer to exercise the rights and purchase the underlying Offered Shares, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

    About Cidara Therapeutics

    Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients' lives. Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE). Cidara is also advancing a second Phase 3 trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT) initially in Europe and Canada. In addition to its robust rezafungin clinical program, Cidara is applying its proprietary Cloudbreak® platform to develop antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases. The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patient's immune system to attack and eliminate pathogens. Cidara is headquartered in San Diego, California.

    Safe Harbor Statement

    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 regarding plans, amounts and timing for the Rights Offering, BVF Partners L.P. and Stonepine Capital, LP's backstop commitment, the anticipated use of proceeds derived therefrom and expectations regarding participation in the Rights Offering. You are cautioned that 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, including the availability of, and participation in, financing opportunities and the risk that the Rights Offering is not completed. These and other risks are identified in our filings with the SEC, including without limitation Cidara's Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 and in other filings subsequently made by Cidara with the SEC. 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

    Primary Logo

    View Full Article Hide Full Article
  28. Rights Offering will be available to all stockholders and 2018 warrant holders of record on January 21, 2020

    $30.0 million to be raised, fully backstopped

    SAN DIEGO, Jan. 10, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX) ("Cidara") today announced its intent to raise $30.0 million through a fully backstopped rights offering. Under the terms of the rights offering, investors as of January 21, 2020 in Cidara's common stock and preferred stock, as well as the holders of Cidara's warrants issued on May 21, 2018, will receive a subscription right entitling them to purchase their pro rata share of the $30.0 million offering amount. The rights offering will be fully backstopped by BVF Partners L.P. and Stonepine Capital, LP, each…

    Rights Offering will be available to all stockholders and 2018 warrant holders of record on January 21, 2020

    $30.0 million to be raised, fully backstopped

    SAN DIEGO, Jan. 10, 2020 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX) ("Cidara") today announced its intent to raise $30.0 million through a fully backstopped rights offering. Under the terms of the rights offering, investors as of January 21, 2020 in Cidara's common stock and preferred stock, as well as the holders of Cidara's warrants issued on May 21, 2018, will receive a subscription right entitling them to purchase their pro rata share of the $30.0 million offering amount. The rights offering will be fully backstopped by BVF Partners L.P. and Stonepine Capital, LP, each of which have agreed to purchase, at a minimum, its respective as-converted pro rata share of the offering amount, plus an additional amount of securities that are not subscribed for by other purchasers in the rights offering, for a total of up to $30.0 million.

    Under the proposed rights offering (the "Rights Offering"), Cidara plans to distribute non-transferable subscription rights to purchase a portion of a share of Cidara's common stock ("Common Stock") for each outstanding share of Common Stock, Common Stock issuable upon conversion of the outstanding shares of Cidara's Series X convertible preferred stock ("Series X Preferred"), and Common Stock issuable upon the exercise of Common Stock Purchase Warrants issued by Cidara on May 21, 2018 ("Warrants"), at $2.51 per share, which is a 15% discount to the 30-day volume weighted average price of Cidara's common stock, to such security holders of record as of the close of business on January 21, 2020 (the "Record Date"). The subscription rights will be exercisable for an aggregate of up to 11,952,191 shares of Common Stock and up to 1,195,219 shares of Series X Preferred, with participation to be allocated among holders of its Common Stock, Series X Preferred and Warrants on a pro rata basis (assuming full conversion of the Series X Preferred into shares of Common Stock and the full exercise of the Warrants into shares of Common Stock), subject to the aggregate offering threshold and ownership limitations. The subscription rights may be exercised only during the anticipated subscription period of Wednesday, January 22, 2020, through 5:00 PM (New York time) on Monday, February 10, 2020, unless extended. Any participant in the Rights Offering that, by exercise of its subscription right would become a holder of greater than 9.99% of the outstanding number of shares of Common Stock following the Rights Offering may elect to instead purchase Series X Preferred. Cidara intends to sell the Series X Preferred at $25.10 per share, and any such holder so electing would have a right to purchase one one-tenth of a share of Series X Preferred for each share of Common Stock it had a right to purchase under the subscription rights. Each share of Series X Preferred are, subject to certain limitations, convertible into 10 shares of Common Stock at the election of the holder. The Series X Preferred generally have no voting rights, except as required by law, and will participate pari passu, on an as-converted basis, with any distribution of proceeds to holders of Common Stock in the event of Cidara's liquidation, dissolution or winding up.

    The Rights Offering will be made pursuant to Cidara's effective shelf registration statement on file with the Securities and Exchange Commission ("SEC") and only by means of a prospectus supplement and accompanying prospectus. Cidara expects to mail subscription certificates evidencing the subscription rights and a copy of the prospectus supplement and accompanying prospectus for the Rights Offering shortly following the Record Date.

    This press release is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities in any jurisdiction, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

    BVF Partners L.P., Cidara's largest stockholder, currently owning approximately 7.9% of the outstanding Common Stock (and approximately 21.1% on an as-converted basis), and Stonepine Capital, LP, a security holder of Cidara (together, the "Backstop Parties"), will together backstop the Rights Offering and have agreed to purchase up to $30.0 million of Common Stock at the subscription price per share of $2.51, and/or Series X Preferred at a price of $25.10 per share in a private placement promptly at the conclusion of the Rights Offering, with the dollar amount to be purchased in such private placement reduced by the dollar amount sold by Cidara (including to BVF Partners L.P. and Stonepine Capital, LP) in the Rights Offering.

    Cantor Fitzgerald & Co. will serve as financial advisor to Cidara in the rights offering.

    About Cidara Therapeutics

    Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients' lives. Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE). Cidara is also advancing a second Phase 3 trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT) initially in Europe and Canada. In addition to its robust rezafungin clinical program, Cidara is applying its proprietary Cloudbreak® platform to develop antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases. The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patient's immune system to attack and eliminate pathogens. Cidara is headquartered in San Diego, California.

    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 regarding plans, amounts and timing for the Rights Offering and the private placement to the Backstop Parties. You are cautioned that 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, including the availability of, and participation in, financing opportunities. These and other risks are identified in our filings with the SEC, including without limitation our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 and in other filings subsequently made by Cidara with the SEC. 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

    Primary Logo

    View Full Article Hide Full Article
  29. SAN DIEGO, Dec. 03, 2019 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that it will present a poster at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, which takes place Dec 7-10, 2019, in Orlando, Fl, and will deliver an oral presentation at the 39th Interdisciplinary Meeting on Anti-Infective Chemotherapy, which takes place Dec 16-17, 2019 in Paris.  

    The presentation at the ASH Annual Meeting will highlight new preclinical data supporting Cidara's rezafungin program for the prevention of invasive fungal infections. The presentation at the Interdisciplinary Meeting on Anti-Infective Chemotherapy will…

    SAN DIEGO, Dec. 03, 2019 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that it will present a poster at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition, which takes place Dec 7-10, 2019, in Orlando, Fl, and will deliver an oral presentation at the 39th Interdisciplinary Meeting on Anti-Infective Chemotherapy, which takes place Dec 16-17, 2019 in Paris.  

    The presentation at the ASH Annual Meeting will highlight new preclinical data supporting Cidara's rezafungin program for the prevention of invasive fungal infections. The presentation at the Interdisciplinary Meeting on Anti-Infective Chemotherapy will provide an overview of Cidara's rezafungin clinical development program for the treatment and prevention of invasive fungal infections.

    Poster Presentation at the 61st ASH Annual Meeting

    Title: Rezafungin Prevention of Pneumocystis Pneumonia and Pneumocystis Reactivation Using Different Doses and Durations of Prophylaxis in a Mouse Model
    Session: 721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities: Poster II
    Presenter: Voon Ong, Ph.D.
    Date and Time: Sunday, Dec. 8, 2019, from 6:00-8:15 p.m. EST
    Location: Orange County Convention Center, Hall B

    Oral Presentation at the 39th Interdisciplinary Meeting on Anti-Infective Chemotherapy

    Title: Antifungals, What's New in 2019?
    Presenter: Taylor Sandison, M.D., M.P.H.
    Date and Time: Monday, Dec. 16, 2019, from 4:45-6:15 p.m. CET
    Location: Palais des Congrès de Paris, Salle 342

    About Cidara Therapeutics
    Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients' lives. Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE). Cidara is also advancing a second Phase 3 trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT) initially in Europe and Canada. In addition to its robust rezafungin clinical program, Cidara is applying its proprietary Cloudbreak® platform to develop antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases. The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patient's immune system to attack and eliminate pathogens. 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 Public Relations
    (929) 469-3860

    Primary Logo

    View Full Article Hide Full Article
  30. SAN DIEGO, Nov. 18, 2019 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that it has been named a Top Workplace by The San Diego Union-Tribune for the third consecutive year. Cidara was the top life sciences company and only biotech included in the small company category in the San Diego Metro Area.

    "It is a great honor to be named as one of the best places to work in the San Diego Metro Area for the third consecutive year," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Our team is essential to our continued success, and we take great pride in cultivating an environment that encourages our employees…

    SAN DIEGO, Nov. 18, 2019 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that it has been named a Top Workplace by The San Diego Union-Tribune for the third consecutive year. Cidara was the top life sciences company and only biotech included in the small company category in the San Diego Metro Area.

    "It is a great honor to be named as one of the best places to work in the San Diego Metro Area for the third consecutive year," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Our team is essential to our continued success, and we take great pride in cultivating an environment that encourages our employees to collaborate, share new ideas and contribute to our mission. This recognition is shared by everyone at Cidara and is a testament to our steadfast commitment to bring lifesaving anti-infectives to patients."

    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, 100 percent of Cidara employees participated in the 2019 survey.

    Reflecting on Cidara's commitment to develop and commercialize novel anti-infectives that have the potential to transform the standard of care and save patients' lives, the Company will continue to build, sustain and invest in its core values that carry through to its culture.

    The San Diego Union-Tribune published the complete list of 2019 Top Workplaces on Sunday, November 17, 2019. The list of winners is available at: https://www.sandiegouniontribune.com/business/story/2019-11-17/winners-of-san-diegos-top-workplaces-2019-contest

    About Cidara Therapeutics
    Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients' lives. Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE). Cidara is also advancing a second Phase 3 trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT) initially in Europe and Canada. In addition to its robust rezafungin clinical program, Cidara is applying its proprietary Cloudbreak® platform to develop antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases. The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patient's immune system to attack and eliminate pathogens. 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 Public Relations
    (929) 469-3860

    Primary Logo

    View Full Article Hide Full Article
  31. SAN DIEGO, Nov. 07, 2019 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today reported financial results for the three months ended September 30, 2019 and provided an update on its corporate activities and product pipeline.

    "The last several months represent a truly transformative period for Cidara. Our partnership with Mundipharma validated the significant commercial potential of rezafungin and provides financial and other resources that enable us to continue to execute on our clinical programs," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "This key partnership was established shortly following the positive results…

    SAN DIEGO, Nov. 07, 2019 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today reported financial results for the three months ended September 30, 2019 and provided an update on its corporate activities and product pipeline.

    "The last several months represent a truly transformative period for Cidara. Our partnership with Mundipharma validated the significant commercial potential of rezafungin and provides financial and other resources that enable us to continue to execute on our clinical programs," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "This key partnership was established shortly following the positive results from the Phase 2 STRIVE B trial, in which rezafungin met all of its objectives for efficacy, safety and tolerability in the treatment of patients with candidemia and/or invasive candidiasis. Moreover, we continued to highlight the compelling preclinical data generated to date from our Cloudbreak® immunotherapy program for influenza at multiple scientific conferences."

    Recent Corporate Highlights

    • Formed strategic partnership with Mundipharma to develop and commercialize rezafungin: In September 2019, Cidara and Mundipharma announced that the companies had entered into a strategic partnership to develop and commercialize rezafungin for the treatment and prevention of invasive fungal infections. Under the terms of the agreement, Mundipharma acquired the exclusive rights to develop and commercialize rezafungin in all markets outside of the United States and Japan, which will be retained by Cidara. Cidara received a $30 million upfront payment and an equity investment of $9 million from Mundipharma.  The total potential transaction value is $568 million, including the equity investment, up-front payment, and certain development, regulatory, and commercial milestones.  Cidara is also eligible for double-digit royalties on tiers of annual net sales.

    • Announced positive top-line results from Phase 2 STRIVE trial of rezafungin: In July 2019, Cidara reported that the Phase 2 STRIVE B trial evaluating its lead antifungal candidate, rezafungin, met all of its primary objectives for efficacy, safety and tolerability in the treatment of patients with candidemia and/or invasive candidiasis.  Trial results were consistent with those from the earlier STRIVE A trial and show that patients treated with rezafungin had numerically improved outcomes as compared to caspofungin across all efficacy measures at the dosing regimen chosen for the ReSTORE Phase 3 trial. 

    • Presented new preclinical data on rezafungin and Cloudbreak at the Infectious Diseases Society of America IDWeek 2019: In October 2019, Cidara presented three posters at IDWeek 2019 from the Company's rezafungin program for the treatment and prevention of invasive fungal infections and from its Cloudbreak program for the treatment and prevention of influenza. 

    • Presented new clinical and preclinical data on rezafungin at the 9th Trends in Medical Mycology (TIMM) meeting: In October 2019, Cidara presented four posters at TIMM. The TIMM presentations contained new clinical and preclinical data for rezafungin, and top-line clinical data from a combined analysis of Parts A and B of the successfully completed STRIVE Phase 2 trial. 

    • Presented preclinical data from the Cloudbreak antiviral (AVC) influenza program at the Options X for the Control of Influenza conference: In August 2019, Cidara presented five abstracts highlighting preclinical data from its Cloudbreak antiviral program. The presentations featured data from preclinical studies evaluating the antiviral activity of CB-012, the first antiviral conjugate generated by Cloudbreak.

    Third Quarter 2019 Financial Results

    • Revenue totaled $19.1 million for the three months ended September 30, 2019.
    • Cash, cash equivalents and short-term investments totaled $73.8 million as of September 30, 2019, compared with $74.6 million as of December 31, 2018.
    • As of September 30, 2019, Cidara had 33,006,280 shares of common stock outstanding, and 565,231 shares of Series X convertible preferred stock outstanding, which are convertible into 5,652,310 shares of common stock.
    • Research and development expenses were $11.5 million and $34.9 million for the three and nine months ended September 30, 2019, respectively, compared to $11.3 million and $36.1 million for the same periods in 2018.
    • General and administrative expenses were $4.6 million and $11.8 million for the three and nine months ended September 30, 2019, compared to $3.4 million and $10.6 million for the same periods in 2018.
    • Net income for the three months ended September 30, 2019 was $3.0 million, compared to a net loss of $13.6 million for the third quarter of 2018. For the nine months ended September 30, 2019 and 2018, the company's net loss was $27.1 million and $46.7 million, respectively.

    About Cidara Therapeutics

    Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients' lives. Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE) and plans to commence a second Phase 3 trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT) initially in Europe and Canada. In addition to its robust rezafungin clinical program, Cidara is applying its proprietary Cloudbreak platform to develop antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases. The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patient's immune system to attack and eliminate pathogens. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Cidara's ability to successfully develop novel anti-infectives, including rezafungin or AVCs from the Cloudbreak program,  whether the Mundipharma collaboration validates the commercial potential of rezafungin and/or will benefit Cidara's financial profile, and whether Cidara will be able to complete the development of rezafungin, meet its obligations under the Mundipharma collaboration and/or receive additional payments from Mundipharma.  Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidara's clinical trials; regulatory developments in the United States and foreign countries; changes in Cidara's plans to develop and commercialize its product candidates; Cidara's ability to obtain additional financing; Cidara's ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Cidara's Form 10-K most recently filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cidara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Cidara Therapeutics, Inc.
    Condensed Consolidated Balance Sheets

      September 30, 2019   December 31, 2018
    (In thousands) (unaudited)    
    ASSETS      
    Cash, cash equivalents, and short-term investments 73,824     74,562  
    Other current assets 3,664     2,567  
    Non-current assets 4,208     1,983  
    Total assets 81,696     79,112  
           
    LIABILITIES AND STOCKHOLDERS' EQUITY      
    Total liabilities 32,734     19,973  
    Stockholders' equity 48,962     59,139  
    Total liabilities and stockholders' equity 81,696     79,112  
               

    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) 2019   2018   2019   2018
    Revenues:              
    Collaboration Revenue $ 19,100     $     $ 19,100     $  
    Total revenues 19,100         19,100      
    Operating expenses:              
    Research and development 11,499     11,278     34,911     36,096  
    General and administrative 4,573     3,447     11,833     10,591  
    Total operating expenses 16,072     14,725     46,744     46,687  
    Income (loss) from operations 3,028     (14,725 )   (27,644 )   (46,687 )
    Other income (expense):              
    Change in fair value of contingent forward purchase obligations     888     411     (224 )
    Interest income, net 11     222     164     447  
    Other income (expense)     (4 )       (210 )
    Total other income 11     1,106     575     13  
    Net income (loss) $ 3,039     $ (13,619 )   $ (27,069 )   $ (46,674 )
    Basic earnings (loss) per common share $ 0.08     $ (0.49 )   $ (1.08 )   $ (2.35 )
    Diluted earnings (loss) per common share $ 0.08     $ (0.49 )   $ (1.08 )   $ (2.35 )
                   
    Shares used to compute basic net income (loss) per common share 33,006,280     27,705,472     25,011,576     24,254,254  
    Shares used to compute diluted net income (loss) per common share 38,687,937     27,705,472     25,011,576     24,254,254  
                           

    INVESTOR CONTACT:
    Brian Ritchie
    LifeSci Advisors
    (212) 915-2578
     

    MEDIA CONTACT:
    Karen O'Shea
    LifeSci Public Relations
     

    Primary Logo

    View Full Article Hide Full Article
  32. SAN DIEGO, Nov. 05, 2019 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that it will host a Key Opinion Leader (KOL) meeting on its rezafungin and Cloudbreak programs on November 14 in New York City for institutional investors, sell-side analysts, and business development professionals.

    The meeting will feature presentations from Key Opinion Leaders, Neil J. Clancy, M.D. (University of Pittsburgh), Kieren Marr, M.D. (Johns Hopkins University School of Medicine), and Allison McGeer, M.D. (University of Toronto), who will discuss the unmet medical need in the treatment and prevention of fungal and viral diseases.

    Cidara's management…

    SAN DIEGO, Nov. 05, 2019 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that it will host a Key Opinion Leader (KOL) meeting on its rezafungin and Cloudbreak programs on November 14 in New York City for institutional investors, sell-side analysts, and business development professionals.

    The meeting will feature presentations from Key Opinion Leaders, Neil J. Clancy, M.D. (University of Pittsburgh), Kieren Marr, M.D. (Johns Hopkins University School of Medicine), and Allison McGeer, M.D. (University of Toronto), who will discuss the unmet medical need in the treatment and prevention of fungal and viral diseases.

    Cidara's management team will also provide a development update on Cidara's core pipeline opportunities, rezafungin, a novel echinocandin antifungal drug in Phase 3 development, and Cloudbreak antiviral conjugates (AVCs), potential single dose universal protectants and treatments for influenza and other viral diseases. Cidara will also provide a corporate overview, including a review of the commercial opportunity for rezafungin and AVCs for influenza.

    Neil J. Clancy, M.D., is a physician and researcher with expertise in infectious diseases. He is a tenured Associate Professor of Medicine, Director of the XDR Pathogen Lab, and Associate Chief of Infectious Diseases at the University of Pittsburgh. He conducts collaborative clinical, translational and laboratory research on issues relevant to the treatment, diagnosis and prevention of infections in immunosuppressed and other vulnerable patient populations. Dr. Clancy is engaged in four inter-related areas of investigation: a) medical mycology (study of fungal infections); b) extensively-drug resistant (XDR) Gram negative bacterial infections and antimicrobial stewardship; c) transplant infectious diseases; and d) Legionella control and environmental management. Dr. Clancy has published over 180 papers in medical journals, and is editor of the American Society for Microbiology's Candida and Candidiasis textbook. He is a member of the Infectious Diseases Society of America Antimicrobial Resistance Committee, and serves on clinical and laboratory guideline committees for the Infectious Diseases Society of America (Candida guidelines), NIH Antimicrobial Resistance Leadership Group, Mycoses Study Group, European Organization for Research and Treatment of Cancer, and European Society for Clinical Microbiology. Dr. Clancy is recognized as a Best Doctor in Pittsburgh for his clinical practice. He has received awards for excellence in teaching medical students and residents at both the University of Pittsburgh and University of Florida.

    Kieren Marr, M.D., is the medical director of the Transplant and Oncology Infectious Diseases Program and a professor of medicine and oncology at the Johns Hopkins University School of Medicine. Dr. Marr, a member of the Johns Hopkins Kimmel Cancer Center, trained at Hahnemann University, Duke University and the University of Washington / Fred Hutchinson Cancer Research Center, where she was on faculty for 13 years prior to relocation to Johns Hopkins in 2008. Dr. Marr is a member of several national and international professional organizations, numerous national scientific steering committees, has authored over 150 peer-reviewed publications and textbook chapters, and edited two books in the area of infectious diseases involving immunosuppressed hosts. She is an elected member of the American Society for Clinical Investigators (ASCI) and the Association of American Physicians (AAP) and is known worldwide for her translational and clinical research focused on diagnostics and treatment of invasive fungal infections. Her research has led to establishment of a JHU spin-off company, MycoMed Technologies, focused on development of early diagnostics to prevent fungal infections in medically immunosuppressed people. She has an active academic interest in medical research innovation and commercialization and serves as Vice Chair of Medicine for Innovation in Healthcare Implementation.

    Allison McGeer, M.D., is a Professor in Laboratory Medicine and Pathobiology at the Dalla Lana School of Public Health at the University of Toronto, and a Clinician Scientist at the Lunenfeld-Tanenbaum Research Institute of the Sinai Health System in Toronto. Her research interests are in the use of epidemiology to reduce the burden of infectious diseases and antimicrobial resistance in adults, and in improving adult immunization. She is a member of the Canadian National Advisory Committee for Immunization's influenza working group, and has been a member of local, national, and international influenza pandemic planning committees.

    This event is intended for institutional investors, sell-side analysts, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. Members of the media and the public are invited to participate via the live webcast.

    About Cidara Therapeutics
    Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients' lives. Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE). Cidara is also advancing a second Phase 3 trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT) initially in Europe and Canada. In addition to its robust rezafungin clinical program, Cidara is applying its proprietary Cloudbreak® platform to develop antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases. The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patient's immune system to attack and eliminate pathogens. 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 Public Relations
    (929) 469-3860

    Primary Logo

    View Full Article Hide Full Article
  33. SAN DIEGO, Oct. 03, 2019 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that it will present three posters at the Infectious Diseases Society of America (IDSA) IDWeek 2019, which takes place October 2-6, 2019, in Washington, D.C., and four posters, including a late-breaking poster, at the 9th Trends in Medical Mycology (TIMM), which takes place October 11-14, 2019, in Nice, France.

    The presentations at IDWeek will highlight new preclinical data from Cidara's rezafungin program for the treatment and prevention of invasive fungal infections and from its Cloudbreak antiviral conjugate (AVC) program for the prevention and treatment…

    SAN DIEGO, Oct. 03, 2019 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that it will present three posters at the Infectious Diseases Society of America (IDSA) IDWeek 2019, which takes place October 2-6, 2019, in Washington, D.C., and four posters, including a late-breaking poster, at the 9th Trends in Medical Mycology (TIMM), which takes place October 11-14, 2019, in Nice, France.

    The presentations at IDWeek will highlight new preclinical data from Cidara's rezafungin program for the treatment and prevention of invasive fungal infections and from its Cloudbreak antiviral conjugate (AVC) program for the prevention and treatment of influenza. The presentations at TIMM will highlight new clinical and preclinical data for rezafungin, including a late-breaking poster with top-line clinical data from a combined analysis of Parts A and B of the successfully completed STRIVE Phase 2 trial, which are being presented for the first time.

    "We are pleased to present these new updates from our advancing rezafungin and Cloudbreak programs to the IDSA and TIMM scientific communities," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "The clinical and preclinical data we are presenting on our rezafungin program further support its development for the treatment and prevention of invasive fungal infections, an area of high unmet medical need, and follow our recent strategic partnership for the development and commercialization of rezafungin in all markets outside of the U.S. and Japan with Mundipharma. At IDWeek, we also look forward to presenting important preclinical efficacy data from our Cloudbreak AVC platform, targeting both influenza A and B."

    Poster presentation details are as follows:

    Infectious Diseases Society of America's IDWeek 2019

    Title: Therapeutic Efficacy of CB-012, a Novel Cloudbreak Antiviral Fc-Conjugate (AVC) in Lethal Mouse Models of Influenza A (H1N1) and Influenza B (Victoria)
    Poster ID: 689
    Presenter: James Levin, Ph.D.
    Date and Time: Thursday, October 3, from 12:15-1:30 p.m. EDT
    Location: Hall B + C
    Session: Novel Antimicrobials and Approaches Against Resistant Bugs

    Title: Potent in vitro Activity of Rezafungin (RZF) Against Aspergillus Clinical Isolates Recovered from Lung Transplant Patients who Have Received ≥3 Months of Triazole Prophylaxis
    Poster ID: 738
    Presenter: Eileen Driscoll, B.S.
    Date and Time: Thursday, October 3, from 12:15-1:30 p.m. EDT
    Location: Hall B + C
    Session: Novel Antimicrobials & Approaches Against Resistant Bugs

    Title: Activity of a Long-Acting Echinocandin Rezafungin and Comparator Antifungal Agents Tested Against Contemporary Invasive Fungal Isolates: SENTRY 2018
    Poster ID: 2115
    Presenter: Cecilia Carvalhaes, M.D., Ph.D.
    Date and Time: Saturday, October 5, from 12:15-1:30 p.m. EDT
    Location: Hall B + C
    Session: Antifungals

    9th Trends in Medical Mycology

    Late-Breaking Title: Rezafungin Clinical Safety and Efficacy in the Treatment of Candidemia and/or Invasive Candidiasis: Combined Results from the STRIVE Phase 2 Trial Parts A and B
    Poster ID: P436
    Presenter: Taylor Sandison, M.D., MPH
    Date and Time: Sunday, October 13, from 11:30 a.m.-12:30 p.m. CEST
    Location: Poster Area
    Session: Poster session 2

    Title: Comparison of Killing Activity of Rezafungin, Anidulafungin, Caspofungin and Micafungin Against Candida auris in the Presence and Absence of Serum
    Poster ID: P055
    Presenter: Zoltán Tóth, Ph.D.
    Date and Time: Sunday, October 13, from 11:30 a.m.-12:30 p.m. CEST
    Location: Poster Area
    Session: Poster session 1

    Title: Frequency of Paradoxical and Trailing Effects with Rezafungin, Anidulafungin, Caspofungin and Micafungin Against Candida Species
    Poster ID: P056
    Presenter: Lajos Forgács, Ph.D.
    Date and Time: Sunday, October 13, from 11:30 a.m.-12:30 p.m. CEST
    Location: Poster Area
    Session: Poster session 2

    Title: Rezafungin in vitro Activity Against Phase 2 STRIVE Part A and Contemporary Nordic Clinical Candida Isolates Determined by EUCAST Reference Method
    Poster ID: P426
    Presenter: Marie Helleberg, M.D., Ph.D., DMSc
    Date and Time: Sunday, October 13, from 11:30 a.m.-12:30 p.m. CEST
    Location: Poster Area
    Session: Poster session 2

    Additional details can be found on the IDWeek 2019 website and TIMM website. A copy of the presentation materials can be accessed on the Publications section of the Cidara website once the presentations conclude.

    About Cidara Therapeutics

    Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients' lives. Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE). Cidara is also advancing a second Phase 3 trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT) initially in Europe and Canada. In addition to its robust rezafungin clinical program, Cidara is applying its proprietary Cloudbreak® platform to develop antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases. The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patient's immune system to attack and eliminate pathogens. 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 Public Relations
    (929) 469-3860
     

     

    Primary Logo

    View Full Article Hide Full Article
  34. WASHINGTON, Oct. 1, 2019 /PRNewswire/ -- The Antimicrobials Working Group (AWG), a coalition of companies with the mission to combat drug-resistant infections and spur life-saving innovations, today announced that eleven of its member companies will present data from their clinical and research programs at IDWeek 2019 to be held October 2-6, 2019 in Washington D.C.

    IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS) that brings together infectious disease professionals to present and discuss the latest approaches in prevention, diagnosis, treatment, and epidemiology…

    WASHINGTON, Oct. 1, 2019 /PRNewswire/ -- The Antimicrobials Working Group (AWG), a coalition of companies with the mission to combat drug-resistant infections and spur life-saving innovations, today announced that eleven of its member companies will present data from their clinical and research programs at IDWeek 2019 to be held October 2-6, 2019 in Washington D.C.

    IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medical Association (HIVMA), and the Pediatric Infectious Diseases Society (PIDS) that brings together infectious disease professionals to present and discuss the latest approaches in prevention, diagnosis, treatment, and epidemiology of infectious diseases.

    "AWG members look forward to joining their peers in the scientific community, from around the world, to present and discuss the newest innovations to combat drug-resistant infections," said Evan Loh, M.D., Chief Executive Officer of Paratek Pharmaceuticals and Chairman of the AWG. "AWG companies will highlight progress in their clinical and research programs in antifungal, antibacterial, and non-traditional therapies in 52 presentations during the conference. These efforts underscore the coalition's commitment to developing new antimicrobial medicines for serious and life-threatening infectious diseases."

    The following AWG member companies will be presenting at IDWeek 2019: Amplyx Pharmaceuticals, Aridis Pharmaceuticals, Cidara Therapeutics Inc., Entasis Therapeutics Inc., Melinta Therapeutics Inc., Nabriva Therapeutics US Inc., Paratek Pharmaceuticals Inc., Qpex Biopharma, Inc., SCYNEXIS Inc., Summit Therapeutics plc, and VenatoRx Pharmaceuticals, Inc.

    For more information on AWG member company presentations and access to specific abstracts, please visit: https://www.antimicrobialsworkinggroup.org/idweek-2019/

    About The Antimicrobials Working Group

    AWG was founded in 2012 with the vision of utilizing collective power to improve the regulatory, investment, and commercial environment for emerging infectious disease companies. Today, AWG is comprised of thirteen antimicrobials companies: Amplyx Pharmaceuticals, Aridis Pharmaceuticals, Cidara Therapeutics Inc. (NASDAQ:CDTX), Entasis Therapeutics Inc. (NASDAQ:ETTX), Iterum Therapeutics Ltd. (NASDAQ:ITRM), Melinta Therapeutics Inc. (NASDAQ:MLNT), Nabriva Therapeutics US Inc. (NASDAQ:NBRV), Paratek Pharmaceuticals Inc. (NASDAQ:PRTK), Qpex Biopharma, Inc., SCYNEXIS Inc. (NASDAQ:SCYX), Summit Therapeutics plc (NASDAQ:SMMT, AIM: SUMM)), VenatoRx Pharmaceuticals, Inc., and X-Biotix Therapeutics, Inc.

    For more information, visit: www.antimicrobialsworkinggroup.org

    About The Conafay Group

    The Conafay Group, led by Stephen R. Conafay, Principal, is a life-sciences government relations firm based in Washington D.C. that serves as Washington counsel and coalition manager for AWG.

    For more information, visit: www.conafaygroup.com

    Cision View original content:http://www.prnewswire.com/news-releases/antimicrobials-working-group-highlights-member-company-participation-at-idweek-2019-300927885.html

    SOURCE Antimicrobials Working Group (AWG)

    View Full Article Hide Full Article
  35. SAN DIEGO, Sept. 16, 2019 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that Paul Daruwala, chief operating officer, and James Levine, chief financial officer of Cidara are scheduled to participate in 1x1 meetings with investors at the Oppenheimer Fall Summit Focused on Specialty Pharma & Rare Disease Companies, which takes place on September 23, 2019, and that Jeffrey Stein, Ph.D., president and chief executive officer of Cidara will present at the 2019 Cantor Global Healthcare Conference, which takes place October 2-4, 2019.  Both conferences will take place in New York City.  The details of Cidara's participation at these conferences…

    SAN DIEGO, Sept. 16, 2019 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that Paul Daruwala, chief operating officer, and James Levine, chief financial officer of Cidara are scheduled to participate in 1x1 meetings with investors at the Oppenheimer Fall Summit Focused on Specialty Pharma & Rare Disease Companies, which takes place on September 23, 2019, and that Jeffrey Stein, Ph.D., president and chief executive officer of Cidara will present at the 2019 Cantor Global Healthcare Conference, which takes place October 2-4, 2019.  Both conferences will take place in New York City.  The details of Cidara's participation at these conferences is as follows:

    Oppenheimer Fall Summit Focused on Specialty Pharma & Rare Disease Companies

    Attendees: Paul Daruwala, chief operating officer, and James Levine, chief financial officer
    Date: Monday, September 23, 2019
       
    2019 Cantor Global Healthcare Conference
       
    Presenter: Jeffrey Stein, Ph.D., president and chief executive officer
    Date: Thursday, October 3, 2019
    Time:  2:25pm Eastern Time / 11:25am Pacific Time
    Webcast: A live audio webcast and replay of the presentation will be available in the Investors section on the company's website at www.cidara.com.

    About Cidara Therapeutics

    Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients' lives. Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE). Cidara is also advancing a second Phase 3 trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT) initially in Europe and Canada. In addition to its robust rezafungin clinical program, Cidara is applying its proprietary Cloudbreak® platform to develop antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases. The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patient's immune system to attack and eliminate pathogens. 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
    LifeSci Public Relations
    929-469-3860

     

    Primary Logo

    View Full Article Hide Full Article
  36. NEW YORK, Sept. 3, 2019 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for CDTX, CGC, GNRC, LOW, and MDCO.

    To see how InvestorsObserver's proprietary scoring system rates these stocks, view the InvestorsObserver's PriceWatch Alert by selecting the corresponding link.

    (Note: You…

    NEW YORK, Sept. 3, 2019 /PRNewswire/ -- InvestorsObserver issues critical PriceWatch Alerts for CDTX, CGC, GNRC, LOW, and MDCO.

    To see how InvestorsObserver's proprietary scoring system rates these stocks, view the InvestorsObserver's PriceWatch Alert by selecting the corresponding link.

    (Note: You may have to copy this link into your browser then press the [ENTER] key.)

    InvestorsObserver's PriceWatch Alerts are based on our proprietary scoring methodology. Each stock is evaluated based on short-term technical, long-term technical and fundamental factors. Each of those scores is then combined into an overall score that determines a stock's overall suitability for investment.

     

    Cision View original content:http://www.prnewswire.com/news-releases/thinking-about-buying-stock-in-cidara-therapeutics-canopy-growth-generac-lowes-or-medicines-co-300910527.html

    SOURCE InvestorsObserver

    View Full Article Hide Full Article
  37. Collaboration combines strengths to develop and commercialize life-saving antifungal treatment and prophylaxis, an area of high unmet medical need

    Mundipharma acquires exclusive rights to develop and commercialize rezafungin in all markets outside of the United States and Japan, which will be retained by Cidara

    Cidara to receive upfront payment of $30 million and equity investment of $9 million, co-development funding, development milestones and tiered royalty stream

    Total transaction value could exceed $568 million

    Cidara to host conference call today at 8:00 a.m. ET/5:00 a.m. PT

    Cidara Therapeutics, Inc. (NASDAQ:CDTX) and Mundipharma announced today that they have entered into a strategic partnership to develop and commercialize…

    Collaboration combines strengths to develop and commercialize life-saving antifungal treatment and prophylaxis, an area of high unmet medical need

    Mundipharma acquires exclusive rights to develop and commercialize rezafungin in all markets outside of the United States and Japan, which will be retained by Cidara

    Cidara to receive upfront payment of $30 million and equity investment of $9 million, co-development funding, development milestones and tiered royalty stream

    Total transaction value could exceed $568 million

    Cidara to host conference call today at 8:00 a.m. ET/5:00 a.m. PT

    Cidara Therapeutics, Inc. (NASDAQ:CDTX) and Mundipharma announced today that they have entered into a strategic partnership to develop and commercialize rezafungin for the treatment and prevention of invasive fungal infections. Rezafungin is a novel, once-weekly echinocandin antifungal being developed for the first-line treatment of candidemia and invasive candidiasis as well as for the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation, for which no new therapies have been approved in over 13 years.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190903005286/en/

    The partnership agreement follows Cidara's recent announcement of the successful completion of its STRIVE B Phase 2 trial. Under the terms of the agreement, in exchange for granting Mundipharma exclusive commercialization rights to rezafungin outside the U.S. and Japan, Cidara will receive a $30 million upfront payment and Mundipharma will make a $9 million equity investment in Cidara. Cidara will also receive an additional $42 million in near-term funding to support the global Phase 3 ReSTORE and ReSPECT trials for the treatment and prevention of fungal infections. In addition, Cidara is eligible to receive development, regulatory and commercial milestone payments, representing a total potential transaction value of $568 million plus double-digit royalties. Cidara will continue to lead the ongoing global Phase 3 development programs for rezafungin with the support of Mundipharma. The companies may pursue additional indications or formulations of rezafungin.

    "This is a transformational collaboration for Cidara, and we look forward to working closely with our colleagues at Mundipharma, a highly successful, profitable company with a commercial presence spanning 120 markets worldwide and annual sales exceeding €2 billion," said Jeffrey Stein, Ph.D., President and Chief Executive Officer of Cidara. "Mundipharma is particularly well positioned globally with established hospital and hematology/oncology business units to fully leverage the commercial potential of rezafungin. Through this partnership, both companies fully commit to advancing rezafungin and helping to save the lives of patients who are highly vulnerable to these deadly infections."

    "By partnering with Cidara on rezafungin, we continue to serve our purpose - to move medicine forward," said Alberto Martinez, Ph.D., M.B.A., President and Chief Executive Officer of Mundipharma. "In a world where antifungal resistance is posing a major threat to the lives of vulnerable immunocompromised patients, rezafungin shows promise to address a major unmet medical need as well as potentially providing a wider spectrum of efficacy in a more convenient administration schedule. With our proven commercial excellence we are confident that we will maximize the potential of this differentiated and innovative asset. Rezafungin will be a significant addition to our pipeline that integrates well with our overall portfolio and sales force capabilities. We are excited to work with the team at Cidara to deliver such an important medicine to patients around the world."

    Conference Call and Webcast

    Cidara management will host a conference call and webcast at 8:00 a.m. ET/5:00 a.m. PT today. The live call may be accessed by dialing (844) 358-8763 for domestic callers and (703) 736-7375 for international callers and entering the conference code: 6567991. The webcast will be made available on Cidara's website at www.cidara.com under the Investors tab in the Events section. Following the live audio webcast, a replay will be available on Cidara's website.

    About Invasive Fungal Infections

    Invasive fungal infections (IFIs) represent a serious threat to millions of patients worldwide, resulting in more than 1.5 million deaths annually and mortality rates ranging from 15 to 65 percent. These infections continue to be a global health issue, especially for critically ill patients in hospitals and patients with compromised immune systems, including cancer and transplant patients. Approximately 90 percent of IFI-related deaths are associated with Candida, Aspergillus, and Pneumocystis.

    About Rezafungin

    Rezafungin is a novel echinocandin antifungal and the only once-weekly drug candidate being developed for the first-line treatment and prevention of serious invasive fungal infections. Rezafungin has a unique pharmacokinetic profile with a prolonged half-life and front-loaded plasma exposure which, in contrast to all other echinocandins, allows for once-weekly IV therapy for inpatient and outpatient use. The U.S. Food and Drug Administration (FDA) has designated rezafungin as a Qualified Infectious Disease Product (QIDP) with Fast Track status and orphan drug designation related to its use in the treatment of candidemia and invasive candidiasis.

    About Cidara Therapeutics

    Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients' lives. Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial for the first-line treatment of candidemia and/or invasive candidiasis (ReSTORE) and plans to commence a second Phase 3 trial of once-weekly rezafungin for prophylaxis against invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation (ReSPECT) initially in Europe and Canada. In addition to its robust rezafungin clinical program, Cidara is applying its proprietary Cloudbreak® platform to develop antiviral conjugates (AVCs) for the prevention and treatment of influenza and other viral diseases. The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patient's immune system to attack and eliminate pathogens. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.

    About Mundipharma

    Mundipharma is a global network of privately-owned independent associated companies whose purpose is to move medicine forward.

    With a high performing and learning organisation that strives for innovation and commercial excellence through partnerships, we successfully transformed and diversified our portfolio of medicines to create value for patients, payers and wider healthcare systems across important therapeutic areas such as Diabetes, Respiratory, Oncology, Pain and Biosimilars.

    For more information please visit: www.mundipharma.com

    Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements relating to the transformational nature and value of Cidara's collaboration with Mundipharma, Cidara's ability to develop new anti-infectives that are innovative or address unmet needs, including Cidara's ability to successfully complete the ReSTORE and ReSPECT Phase 3 clinical trials, Cidara's ability to complete development of, obtain regulatory approval for and commercialize rezafungin including Cidara's ability to receive milestone payments for the achievement of development milestones, the potential for rezafungin to successfully treat or prevent invasive fungal infections and represent an improvement over current approaches, and the ability of Cidara's Cloudbreak program to successfully identify and develop product candidates to prevent and/or treat viral diseases, and other diseases. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidara's clinical trials; regulatory developments in the United States and foreign countries; changes in Cidara's plans to develop and commercialize its product candidates; Cidara's ability to obtain additional financing; Cidara's ability to obtain and maintain intellectual property protection for its product candidates; and the loss of key scientific or management personnel. These and other risks and uncertainties are described more fully in Cidara's most recent filings with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cidara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    View Full Article Hide Full Article