Newly Published Data Reinforce Growing Body of Evidence Supporting Cidara Therapeutics’ Lead Antifungal CD101

Data Showcase Compound’s Discovery through Development and Potential to Expand Echinocandin Utility Across Multiple Infectious-Disease Indications

SAN DIEGO--(BUSINESS WIRE)--Dec. 14, 2016-- Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that data from preclinical and clinical studies evaluating the company’s novel echinocandin antifungal CD101 appear in the December 5 online issue of the journal Antimicrobial Agents and Chemotherapy (AAC). These latest findings add to the growing body of published scientific evidence that demonstrate the unique attributes of Cidara’s lead antifungal drug candidate and showcase the compound’s strategic discovery and rapid development.

“The publication of these latest findings in AAC further affirms the clinical utility, safety and unique profile of CD101 across a number of infectious-disease indications, including treatment and prophylaxis of invasive fungal infections and treatment of vulvovaginal candidiasis,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We now have a compendium of published data on CD101 that demonstrate the quality and scientific rigor behind our antifungal drug development program. The discovery and development of CD101 has unlocked a molecule, now in multiple Phase 2 clinical trials, with differentiating properties and utility far beyond that of currently approved echinocandins.”

In total, seven CD101 manuscripts were published during the second half of 2016:

  • Safety and Pharmacokinetics of CD101 IV, a Novel Echinocandin, in Healthy Adults, Antimicrobial Agents and Chemotherapy, December 2016
  • Structure-Activity Relationships of a Series of Echinocandins and the Discovery of CD101, a Highly Stable and Soluble Echinocandin with Distinctive Pharmacokinetic Properties, Antimicrobial Agents and Chemotherapy, December 2016
  • Preclinical Evaluation of the Stability, Safety and Efficacy of CD101, a Novel Echinocandin, Antimicrobial Agents and Chemotherapy, November 2016, Volume 60, Issue 11
  • Activity of a long-acting echinocandin, CD101, determined using CLSI and EUCAST reference methods, against Candida and Aspergillus spp., including echinocandin- and azole-resistant isolates, Journal of Antimicrobial and Chemotherapy, October 2016, Volume 71, Issue 10
  • Characterization of in vitro resistance development to the novel echinocandin, CD101, in Candida species, Antimicrobial Agents and Chemotherapy, September 2016, Volume 60, Issue 10
  • CD101: a novel long-acting echinocandin, Cell Microbiology, September 2016, Volume 18, Issue 9
  • CD101, a novel echinocandin with exceptional stability properties and enhanced aqueous solubility, The Journal of Antibiotics, August 2016

Links to the full text of these publications are also available on the Cidara website: https://www.cidara.com/publications/

About Invasive Fungal Infections

Fungal infections can carry a mortality rate of 35-50 percent, higher than most bacterial infections. Approximately 97,000 Americans die from hospital-related fungal infections each year and 90 percent of these infections are caused by two common fungi, Candida and Aspergillus. There is an urgent and growing need for new therapeutic approaches to treat and prevent serious invasive fungal infections.

About Vulvovaginal Candidiasis (VVC)

Vulvovaginal candidiasis (VVC) is a highly prevalent mucosal fungal infection which impacts approximately 75 percent of women in America. Many have moderate to severe symptoms and four to five million are estimated to have recurrent infections. Current VVC treatments have significant limitations and there have been no novel therapies approved for the condition in more than 20 years. Between 30 to 40 percent of women fail acute VVC therapy and 50 percent relapse with recurrent VVC within six months. Current therapies are fungistatic, not fungicidal (meaning they inhibit the growth of fungus but may not kill the fungus), and do not cover non-albicans Candida strains.

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, and its differentiation from other therapies. 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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