Cidara Therapeutics To Present Data On Lead Antifungal Product Candidate CD101 At Upcoming ASM Microbe 2016

Results from Multiple Dose Phase 1 Trial of CD101 IV Supporting High-Exposure, Once-Weekly Dosing Will Be Presented For the First Time

SAN DIEGO--(BUSINESS WIRE)--Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced that data from preclinical and clinical studies evaluating its lead antifungal product candidate, CD101, will be presented at the American Society for Microbiology (ASM) Microbe 2016 meeting in Boston from June 16-20.

“We and our scientific collaborators look forward to sharing the latest results from our ongoing clinical research on CD101, which highlight the efficacy, safety and versatility of this compound as well as the rapid progress we’ve made with our development programs for CD101 IV and topical.”

In total, four oral and two poster presentations regarding Cidara’s novel echinocandin CD101 have been accepted for presentation. They include a late-breaker poster presentation on the successful Phase 1 multiple ascending-dose clinical trial of CD101 IV, representing the first time these results will be presented at a medical meeting. The data to be presented support the continued development of CD101 IV as a once-weekly, high-exposure echinocandin. Additional data to be presented at ASM Microbe build on Cidara’s understanding of the clinical profile of CD101 and reinforce its commitment to addressing significant unmet medical needs for new antifungals to treat serious fungal infections.

“The scope of data to be presented at ASM Microbe 2016 underscore Cidara’s commitment to pursuing novel antifungal therapies,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We and our scientific collaborators look forward to sharing the latest results from our ongoing clinical research on CD101, which highlight the efficacy, safety and versatility of this compound as well as the rapid progress we’ve made with our development programs for CD101 IV and topical.”

The ASM Microbe 2016 presentations are:

Oral Presentations:

Friday, June 17: Session 016 - New Antifungals (8:15 a.m. – 10:45 a.m. ET, Westin, Marina Ballroom III)

• Optimization of CD101 Formulation Against Candida albicans in a Rat Model of Vulvovaginal Candidiasis; V. Ong, et. al. (8:15 a.m.)
• Prevention of Pneumocystis Pneumonia by the Long Acting Echinocandin CD101; M.T. Cushion, et. al. (8:30 a.m.)
• Efficacy of a Novel Echinocandin, CD101, in a Mouse Model of Azole-Resistant Disseminated Candidiasis; L. Miesel, et. al. (8:45 a.m.)

Sunday, June 19: Session 247 - Innovations and Challenges in Pharmacokinetics/Pharmacodynamics (PK/PD) (8:15 a.m. - 10:45 a.m. ET, BCEC, Meeting Room 156A)

• Tissue Distribution and Pharmacokinetics of CD101 in an Immunocompetent Mouse Model of Invasive Candidiasis; Y. Zhao, D. S. Perlin, et. al. (9:00 a.m.)

Poster Presentations:

Saturday, June 18: Session 150 - Late-Breaker Poster Presentations (12:45 p.m. – 2:45 p.m. ET, Exhibit and Poster Hall, Halls A and B)

• LB-057: Safety and Pharmacokinetics of Multiple Doses of CD101 Injection: Results from a Phase 1, Dose-escalation Study; T. Sandison, et. al.

Sunday, June 19: Session 309 - Pre-Clinical Pharmacokinetic/Pharmacodynamic (PK/PD) (12:30 p.m. - 2:30 p.m., ET, BCEC, Exhibit and Poster Hall, Halls A and B)

• *SUNDAY-505: Pharmacological Basis of CD101 Efficacy: Exposure Shape Matters; E. A. Lakota, P. G. Ambrose, et. al.

*This poster will be showcased during the Poster Walk on Sunday, June 19 from 12:30 p.m. - 1:30 p.m., ET, in Hall A, which will include a 3-5 minute live summary of the poster followed by a brief question and answer period.

Copies of these posters will be available on the Cidara website following the ASM Microbe 2016 meeting: http://www.Cidara.com/

About Cidara Therapeutics

Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives for the treatment of diseases that are inadequately addressed by current standard-of-care therapies. Cidara’s initial product portfolio comprises two formulations of the company’s novel echinocandin, CD101. CD101 IV is being developed as a once-weekly, high-exposure therapy for the treatment and prevention of serious, invasive fungal infections. CD101 topical is being developed for the treatment of vulvovaginal candidiasis (VVC) and the prevention of recurrent VVC (RVVC), a prevalent mucosal infection. In addition, Cidara has developed a proprietary immunotherapy platform, Cloudbreak™, designed to create compounds that direct a patient’s immune cells to attack and eliminate pathogens that cause infectious disease. 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 effectiveness, safety, long-acting nature, anticipated human dosing and other attributes of CD101 IV and CD101 topical, and their potential to treat infections, as well as the intended design of current and future Cloudbreak™ compounds. 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.