Cidara Announces Data From Studies Of Novel Antifungal CD101 To Be Presented At ACCP And IDweek Annual Meetings

Data Highlight Safety and Efficacy of CD101 IV and CD101 Topical for the Treatment of Fungal Infections

SAN DIEGO--(BUSINESS WIRE)--Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that data from preclinical and clinical studies evaluating its novel echinocandin antifungal CD101 as a potential treatment for serious infections will be presented at the 2016 American College of Clinical Pharmacy (ACCP) Annual Meeting in Hollywood, Florida from October 23-26 and at the IDWeek 2016 meeting in New Orleans, Louisiana from October 26-30.

“These presentations showcase the breadth and depth of our work to advance CD101, a compound with demonstrated potential to address the urgent unmet need for new and effective antifungal agents”

A total of five presentations will highlight the unique attributes of CD101, Cidara’s lead antifungal drug candidate and the only long-acting antifungal in the echinocandin class. In December 2015, the Infectious Diseases Society of America (IDSA) issued new clinical guidelines recommending a shift to echinocandins as first-line treatment for invasive candidiasis and candidemia, serious infections that are often fatal. Cidara is advancing two formulations of CD101 to address two areas of high unmet need, both of which are currently in Phase 2 clinical trials.

“These presentations showcase the breadth and depth of our work to advance CD101, a compound with demonstrated potential to address the urgent unmet need for new and effective antifungal agents,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “New solutions that address the unmet needs of and increasing resistance to current standard-of-care treatments have become increasingly critical, as demonstrated by the recent United Nations General Assembly declaration that antimicrobial resistance is a major global health issue. We are developing both IV and topical formulations of CD101 to provide truly differentiated and broadly useful antifungal therapies that will have multiple advantages over existing therapies.”

Details of the Cidara ACCP and IDWeek 2016 presentations are as follows:

ACCP 2016 Presentations

Tuesday, October 25: Scientific Poster Session IV – Original Research (8:00 a.m. – 10:00 a.m. ET, Diplomat Resort & Spa, East/West Grand Ballroom)

• 258: Safety and Pharmacokinetics of Single and Multiple Doses of CD101 IV: Results from Two Phase 1 Dose-Escalation Studies; T. Sandison, et. al.
• 261E: Pharmacological Basis of CD101 Efficacy: Exposure Shape Matters; E.A. Lakota, et. al.

IDWeek 2016 Presentations

Friday, October 28: Session 163 – Mycology – There’s a Fungus Among Us: Treatment (12:30 p.m. – 2:00 p.m. ET, New Orleans Convention Center, Poster Hall)

• 1625: Activity of a Long Acting Echinocandin (CD101) and Comparator Antifungal Agents Tested Against Contemporary Worldwide Invasive Fungal Isolates; M. Pfaller, et. al.
• 1639: Efficacy of Topical CD101, a Novel Echinocandin, Against Azole-Resistant Candida albicans in Rat Vulvovaginal Candidiasis; V. Ong, et. al.

Saturday, October 29: Session 227 – Antimicrobial Pharmacokinetics and Pharmacodynamics (12:30 p.m. – 2:00 p.m. ET, New Orleans Convention Center, Poster Hall)

• 1994: PK-PD Target Attainment Analyses to Support the Selection of Extended Interval CD101 Dosing Regimens; E.A. Lakota, et. al.

Copies of these presentations and posters will be available on the Cidara website following the meetings: http://www.Cidara.com/

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, CD101, through Phase 2 studies in two indications and developing CD201, its bispecific antimicrobial immunotherapy, for the treatment of multi-drug resistant bacterial infections. CD101 IV has enhanced potency and is the only once-weekly therapy intended for the treatment and prevention of life-threatening invasive fungal infections. CD101 topical is the first and only agent of its class being studied for the treatment and prevention of vulvovaginal candidiasis (VVC), a prevalent mucosal infection. CD201 is the first drug candidate selected from Cidara’s novel Cloudbreak™ platform, the first immunotherapy discovery platform designed specifically to create compounds that 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 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.