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Cidara Therapeutics to Present New Data at ASH 2018 Highlighting Potential of Rezafungin to Prevent Invasive Fungal Infections in Bone Marrow Transplant Patients

November 27, 2018

SAN DIEGO--(BUSINESS WIRE)--Nov 27, 2018--Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that the company will present new data highlighting the potential of rezafungin to prevent invasive fungal infections in bone marrow transplantation (BMT) patients at the 60th American Society of Hematology (ASH) Annual Meeting. The 2018 ASH Meeting will be held December 1-4 in San Diego.

The rezafungin ASH abstract ( 2071 ), titled “Pharmacokinetic-Pharmacodynamic Analyses to Provide Rezafungin Prophylaxis Dose Selection for Prevention of Invasive Fungal Infections for Bone Marrow Transplant Patients,” will be presented in a poster session on Saturday, December 1. Fungal infections are a leading cause of morbidity and mortality among immunocompromised patients, particularly those undergoing bone marrow transplantation.

“The data we will present at ASH are important because they provide further support that a once-weekly dosing regimen of rezafungin can help to prevent life-threatening fungal infections in high-risk patients,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We believe rezafungin can address this serious unmet medical need in immunocompromised patients and has the potential to be the only single agent approved to prevent infections caused by common fungal pathogens in bone marrow transplant patients.”

Rezafungin is a novel antifungal echinocandin being developed as a once-weekly therapy for the treatment and prevention of serious invasive fungal infections. Rezafungin is being developed to address unmet needs in the treatment of candidemia and invasive candidiasis as well as for prophylaxis of invasive fungal infections due to the common fungal pathogens Candida, Aspergillus and Pneumocystis. Cidara plans to start the Phase 3 ReSPECT prophylaxis clinical trial of rezafungin in patients undergoing allogeneic bone marrow transplantation in the first quarter of 2019.

About Invasive Fungal Infections

Approximately 97,000 Americans die from hospital-related invasive fungal infections each year and 90 percent of these infections are caused by two common fungi, Candida and Aspergillus. Pneumocystis Pneumonia (PCP) is another serious fungal infection that commonly afflicts people with weakened immune systems. Systemic fungal infections typically affect patients whose immune systems have been compromised, such as patients undergoing organ or bone marrow transplantation or chemotherapy, including patients with hematologic malignancies, or patients in intensive care units and those with prolonged hospital stays.

About Cidara Therapeutics

Cidara is a clinical-stage biotechnology company focused on developing new anti-infectives that have the potential to transform the standard of care and save or improve patients’ lives. The company is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial in the treatment of candidemia and invasive candidiasis and plans to initiate a second Phase 3 trial in the prophylaxis of invasive fungal infections. Rezafungin has improved pharmacokinetics compared to existing echinocandins and the potential for expanded utility across patient settings. It is the only once-weekly product candidate in development for the treatment and prevention of life-threatening invasive fungal infections. Cidara also is leveraging its novel Cloudbreak™ platform to develop antibody-drug conjugates for the treatment of serious viral and Gram-negative bacterial infections. Cloudbreak is the first immunotherapy discovery platform designed specifically to create compounds that directly kill pathogens and also direct a patient’s immune cells to attack and eliminate bacterial, fungal or viral 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, statements regarding the potential for rezafungin to be a novel treatment and prophylactic agent against deadly invasive fungal infections, statements regarding the potential for expanded utility across patient settings, such as immunocompromised patients, as well as statements regarding rezafungin’s ability to mitigate the challenges typically associated with prophylaxis of invasive fungal infections in immunocompromised and bone marrow transplant patients, and statements regarding the time of initiation of rezafungin Phase 3 pivotal trials. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidara’s preclinical studies and 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-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.

View source version on businesswire.com:https://www.businesswire.com/news/home/20181127005460/en/

CONTACT: INVESTOR CONTACT:

Robert H. Uhl

Westwicke Partners, LLC

Managing Director

(858) 356-5932

robert.uhl@westwicke.comMEDIA CONTACT:

Christy Curran

Sam Brown Inc.

615-414-8668

ChristyCurran@sambrown.com

KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA

INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY INFECTIOUS DISEASES ONCOLOGY PHARMACEUTICAL OTHER HEALTH GENERAL HEALTH

SOURCE: Cidara Therapeutics, Inc.

Copyright Business Wire 2018.

PUB: 11/27/2018 08:00 AM/DISC: 11/27/2018 08:01 AM

http://www.businesswire.com/news/home/20181127005460/en

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