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

By March 30, 2017No Comments

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

SAN DIEGO –
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.

INVESTOR CONTACT:
Westwicke Partners, LLC
Robert H. Uhl
Managing
Director
858-356-5932
robert.uhl@westwicke.com
or
MEDIA
CONTACT:

Sam Brown Inc.
Christy Curran
615-414-8668
ChristyCurran@sambrown.com