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Cidara Therapeutics and Rutgers University Awarded $5.5 Million Grant from NIH to Support Development of Novel Immunotherapy Agents Targeting Multi-drug Resistant Gram-negative Bacterial Infections

New Partnership to Jointly Conduct Preclinical Development of Cidara’s Cloudbreak Antibody-Drug Conjugates

SAN DIEGO--(BUSINESS WIRE)--May 21, 2018-- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that it and Rutgers University have been awarded a five-year, $5.5 million partnership grant from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services.

The grant will fund the continued research and development of Cidara’s innovative Cloudbreak™ antibody-drug conjugate (ADC) platform to identify novel immunotherapy agents for the treatment and prevention of serious and life-threatening multi-drug resistant (MDR) Gram-negative bacterial infections in high-risk patient populations. The Cloudbreak immunotherapy platform is a fundamentally new approach for the treatment of infectious disease that, in a single molecule, pairs potent antimicrobials with agents that redirect the immune system to destroy fungal, bacterial and viral pathogens.

“Treatment options for Gram-negative bacterial infections have become increasingly limited due to the rapid emergence of multi-drug resistance to existing and newly approved antimicrobial agents,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “An agent designed to treat and prevent Gram-negative infections in high-risk populations by engaging the immune system would provide an alternative strategy for addressing a critical public health need. We are pleased to collaborate with the NIH and Rutgers to further evaluate potential use of our Cloudbreak ADCs as countermeasures against Gram-negative pathogens.”

The initial preclinical development activities covered by the grant will be conducted at the Public Health Research Institute (PHRI) of New Jersey Medical School, Rutgers University, located in Newark, New Jersey. David S. Perlin, Ph.D., executive director and professor at PHRI, will lead the research phase of the grant and serves as principal investigator.

“Preliminary studies have identified promising ADCs that possess both intrinsic and immune-mediated bactericidal activity against clinically important Gram-negative pathogens including MDR isolates,” said Dr. Perlin. “I believe that a novel ADC agent could be a much-needed and welcome addition to the Gram-negative therapeutic arsenal. I look forward to advancing Cidara’s ADC Cloudbreak program as part of this NIH/NIAID partnership grant.”

About Gram-negative Bacterial Infections

Gram-negative pathogens are responsible for half of all healthcare associated infections (HAIs) and the primary cause of HAIs in intensive care units (ICU). The Centers for Disease Control and Prevention (CDC) estimates that there were 1.7 million total HAIs in the United States and the estimated number of death associated with HAIs were 99,000, costing the U.S. health care system $20 billion per year. While mortality due to these infections is already high, infections caused by MDR strains result in significantly higher mortality and hospital length of stay when compared to those caused by susceptible strains.

About NIAID and NIH

The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world. NIAID is one of the 27 Institutes and Centers of the National Institutes of Health (NIH). For more information, visit www.niaid.nih.gov.

The National Institutes of Health (NIH) - the nation's medical research agency - includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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 Cidara plans to initiate Phase 3 pivotal trials in the treatment of candidemia and invasive candidiasis and the prophylaxis of invasive fungal infections in 2018. 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.

About Rutgers University and New Jersey Medical School

Rutgers, The State University of New Jersey, is a leading national research university and the state of New Jersey’s preeminent, comprehensive public institution of higher education. Established in 1766, the university is the eighth oldest higher education institution in the United States. More than 69,000 students and 22,500 full- and part-time faculty and staff learn, work, and serve the public at Rutgers locations across New Jersey and around the world. The mission of New Jersey Medical School is to educate students, physicians, and scientists to meet society’s current and future healthcare needs through patient-centered education; pioneering research; innovative clinical, rehabilitative and preventive care; and collaborative community outreach.

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 the full grant proceeds to be received and used by Cidara and Rutgers University, and the potential for Cidara’s ADCs to be successfully developed and be safe and effective in treating and preventing bacterial infections. 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.

Research reported in this publication was supported by the National Institute of Allergy And Infectious Diseases of the National Institutes of Health under Award Number R01AI138986. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Source: Cidara Therapeutics, Inc.

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