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Data to be Presented at ASM Microbe 2018 Demonstrate the Efficacy and Safety of Cidara’s Rezafungin for the Treatment of Invasive Fungal Infections
May 23, 2018 at 8:00 AM EDT

Four accepted presentations include a late-breaker featuring Phase 2 STRIVE trial data and three posters describing the activity of rezafungin against fungal pathogens

SAN DIEGO--(BUSINESS WIRE)--May 23, 2018-- Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that it will present four posters highlighting data from preclinical studies and a clinical trial of rezafungin, its lead antifungal product candidate, at the American Society for Microbiology (ASM) Microbe 2018, being held June 7-11 in Atlanta. Cidara’s presentations will include a late-breaker poster detailing results from the Phase 2 STRIVE clinical trial, which evaluated rezafungin as a once-weekly, high-exposure intravenous therapy for the treatment of serious invasive fungal infections. Preclinical data to be presented include evaluation of the mutant prevention concentration of rezafungin, which may indicate a potential to suppress antifungal resistance.

“At ASM Microbe 2018, we will present topline results from Part A of our multinational STRIVE trial that demonstrated the efficacy and safety of rezafungin and its potential as a once-weekly treatment option for patients with difficult-to-treat and often deadly invasive Candida infections. These data provide support for the advancement of rezafungin into Phase 3 pivotal trials in both treatment and prophylaxis,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “In the face of significant unmet needs in the prevention and treatment of invasive fungal infections and the challenges of antifungal resistance, we are pleased to share our latest findings and add to the growing body of data demonstrating the expanded clinical utility of rezafungin.”

ASM Microbe 2018 is the main forum for microbial sciences and considers and debates scientific issues, connects scientists and explores the complete spectrum of microbiology from basic science to translation and application. Details of Cidara’s poster presentations at the forum are as follows:

Title: Clinical Efficacy and Safety of Rezafungin (CD101): Results from STRIVE, a Randomized, Double-blind, Multicenter, Phase 2 Study in the Treatment of Candidemia and/or Invasive Candidiasis
Presenter: T. Sandison
Date and time: Friday, June 8, 11:00 a.m.1:00 p.m. Eastern Time
Location: Exhibit and Poster Hall, Building B, Halls B2-B5
Session 048: FRIDAY - AAR Late-breakers
Poster number: FRIDAY-AAR LB21

Title: Activity of a Long-Acting Echinocandin Rezafungin (CD101) and Comparator Antifungal Agents Tested against Contemporary Invasive Fungal Isolates: SENTRY 2016
Presenter: M. Castanheira
Date and time: Friday, June 8, 11:00 a.m.1:00 p.m. Eastern Time
Location: Exhibit and Poster Hall, Building B, Halls B2-B5
Session 054: AAR03 - Antifungal Agents and Resistance: Agents to Treat Fungal Infections
Poster number: FRIDAY-485

Title: CD101 Exhibits Low Minimum Inhibitory and Mutant Prevention Concentrations against Candida glabrata Clinical Isolates
Presenter: K. Squires
Date and time: Friday, June 8, 11:00 a.m.1:00 p.m. Eastern Time
Location: Exhibit and Poster Hall, Building B, Halls B2-B5
Session 054: AAR03 - Antifungal Agents and Resistance: Agents to Treat Fungal Infections
Poster number: FRIDAY-496

Title: Establishment of Quality Control Ranges for the Broth Microdilution Susceptibility Testing of Rezafungin against Yeast
Presenter: C. Pillar
Date and time: Friday, June 8, 11:00 a.m.1:00 p.m. Eastern Time
Location: Exhibit and Poster Hall, Building B, Halls B2-B5
Session 054: AAR03 - Antifungal Agents and Resistance: Agents to Treat Fungal Infections
Poster number: FRIDAY-507

Copies of these presentations will be available on the Cidara website following the meeting: www.cidara.com

About STRIVE

STRIVE is an international, multicenter, double-blind, Phase 2 trial evaluating the safety, tolerability and efficacy of once-weekly dosing of rezafungin acetate compared to once-daily dosing of caspofungin in patients with candidemia and/or invasive candidiasis. The STRIVE trial results (Part A) include efficacy data from 92 treated patients (mITT population), and safety and tolerability results in 104 patients from 31 trial sites in North America and Europe. The trial was not statistically powered to demonstrate superiority or non-inferiority and, therefore, comparisons of efficacy are directional.

STRIVE Part A met all of its primary objectives, as once-weekly intravenous dosing of rezafungin was observed to be generally well tolerated and safe in patients with candidemia and/or invasive candidiasis. The results also provide evidence of rezafungin efficacy, which was defined in the trial by clearance of Candida from the blood or other normally sterile sites, resolution of signs related to the infection, investigator assessment of clinical response, and overall survival.

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 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, formerly known as CD101 IV, through clinical trials. 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. The company’s Phase 2 STRIVE clinical trial of rezafungin met its primary safety and efficacy objectives, and provide support for Cidara to initiate Phase 3 pivotal trials in the treatment of candidemia and invasive candidiasis and the prophylaxis of invasive fungal infections. Cidara also is leveraging its novel Cloudbreak™ platform to develop antibody-drug conjugates for the treatment of multi-drug resistant 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, the potential for rezafungin to successfully treat or prevent invasive fungal infections and represent an improvement over current approaches, and Cidara’s ability to successfully develop rezafungin. 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.

Source: Cidara Therapeutics, Inc.

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