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Cidara Therapeutics Awarded $6.9 Million Grant from CARB-X to Advance Development of its First CloudbreakTM Antibiotic Immunotherapy

CARB-X Funding to Advance Novel First-in-Class Bispecific Immunotherapy to Fight Multi-drug Resistant Bacterial Infections

SAN DIEGO--(BUSINESS WIRE)--Mar. 30, 2017-- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that the company has received a grant for up to $6.9 million from CARB-X (Combating Antibiotic Resistant Bacteria Accelerator) to advance the development of its antibiotic immunotherapy, CD201, for the treatment of life-threatening multi-drug resistant (MDR) Gram-negative bacterial infections. CD201 is the first development candidate to be generated by Cidara’s novel Cloudbreak™ immunotherapy discovery platform, designed specifically to create compounds that direct a patient’s immune cells to attack and eliminate bacterial, fungal or viral pathogens.

CARB-X is the world’s largest public-private partnership focused on antibacterials, created by the U.S. Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID). CARB-X is funded by BARDA and the London-based Wellcome Trust, a global charitable foundation, and administered by the Boston University School of Law.

“This grant from CARB-X validates the progress we’ve made to date with our Cloudbreak platform,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We believe that the Cloudbreak immunotherapy approach has the potential to transform the way infectious diseases are treated, similar to the way immunotherapy has transformed cancer treatment. With this valuable support from CARB-X, we look forward to accelerating the development of CD201 through the critical early stages, including continuing our IND-enabling studies.”

Following a competitive review process, CARB-X selected Cidara’s CD201 product candidate for its first phase of funding awarded to companies with pre-clinical development projects in the area of antibiotic-resistant infections, a serious global health threat. Under the grant, CARB-X will provide up to $3.9 million in base funding and up to $3.0 million in additional funding through Phase 1, linked to the successful progression of the project through milestones established by CARB-X.

To be considered, the clinical project must target one of the deadly antibiotic-resistant bacteria on the Serious or Urgent Threat List prepared by the U.S. Centers for Disease Control and Prevention (CDC) or appear on the Priority Pathogens list published by the World Health Organization (WHO). The first projects selected for the Powered by CARB-X portfolio focus on Gram-negative bacteria, which are responsible for half of all healthcare associated infections many of which are resistant to multiple drugs.

The rise in drug-resistant bacteria is a growing public health concern. In the U.S. alone, the CDC estimates that 23,000 people die each year from drug-resistant infections, with related healthcare costs of approximately $20 to $25 billion. In addition, a recent CDC report highlighted the urgent need for novel antibacterials that are effective against Gram-negative bacteria.

About CD201

CD201 is a first-in-class, bispecific antibiotic immunotherapy being developed for the treatment of multi-drug resistant bacterial infections, including those caused by MCR-1-producing pathogens. CD201 works by binding to a target present on a wide range of Gram-negative bacteria, including MCR-1-positive strains, while simultaneously recruiting immune components to an infection site to coordinate localized host-mediated infection clearance. CD201 has demonstrated potent antibacterial activity in vitro against a number of clinically significant Gram-negative bacteria, including Klebsiella, Acenitobacter, Pseudomonas and Enterobacter spp. and resistant pathogens (including bacteria resistant to carbapenems and colistin), as well as pathogens harboring the mcr-1 plasmid. CD201 also has demonstrated preliminary efficacy and safety in a number of animal models of infection. More information about CD201 and Cloudbreak can be viewed in the video available here: https://www.cidara.com/cloudbreak/video/.

About CARB-X

CARB-X is the world’s largest public-private partnership devoted to antibacterial preclinical R&D. Funded by BARDA and Wellcome Trust, with in-kind support from NIAID, CARB-X will spend $450 million from 2017-2021 to support innovative products moving towards human clinical trials. CARB-X focuses on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X is a charitable global public-private partnership led by Boston University School of Law. Other partners include the Broad Institute of Harvard and MIT, MassBio, the California Life Sciences Institute and RTI International. For more information, please visit www.carb-x.org and follow us on Twitter @CARB_X.

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 IV, through Phase 2 and developing CD201, its bispecific antibiotic immunotherapy, for the treatment of multi-drug resistant Gram-negative 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. 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, and other attributes of CD201, including the potential for CD201 to successfully treat bacterial infections, complete IND-enabling studies and clinical trials, and potentially transform the way infectious diseases are treated, the potential for the second phase of the CARB-X grant to be funded, and the potential for the Cloudbreak platform to result in future drug candidates. 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-K 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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