Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, today
reported financial results for the three months ended June 30, 2017
and provided an update on its corporate activities and product
pipeline.
“We began the second quarter of 2017 by welcoming the financial
community to our inaugural Investor Day, in New York, where we
described plans for our CD101 and Cloudbreak™ programs and heard
presentations from key opinion leaders,” said Jeffrey Stein, Ph.D.,
president and chief executive officer of Cidara. “We have continued
to actively engage with the scientific community at conferences,
and enroll patients in our STRIVE Phase 2 trial of CD101 IV in
candidemia and invasive candidiasis. In addition, we continue to
advance CD201, the first drug candidate from our Cloudbreak™
immunotherapy platform, through IND-enabling studies.”
Second Quarter 2017 and Subsequent
Highlights
• Announced publication of data from a study
investigating the deep tissue distribution of CD101: In
August 2017, Cidara announced publication of data from an in vivo
study demonstrating that CD101 had superior tissue penetration
within the site of infection compared to the current standard of
care echinocandin in the U.S., micafungin, in intra-abdominal
candidiasis (IAC) infections, one of the most lethal forms of
invasive candidiasis.
• Presented Data at ASM Microbe 2017 and the 22nd
Congress of the European Hematology Association: In June
2017, Cidara presented data from nonclinical studies of its novel
echinocandin antifungal CD101 at ASM Microbe 2017 in New Orleans,
and at the 22nd Annual Congress of the European Hematology
Association (EHA), in Madrid, Spain, demonstrating efficacy in
prophylaxis of Candida, Aspergillus and PCP (Pneumocystis
pneumonia).
• Presented Data at ECCMID and SID Annual
Meetings: In April 2017, Cidara presented data from
nonclinical studies of CD101 and its Cloudbreak antibacterial
immunotherapy CD201 at the 2017 Society for Investigative
Dermatology (SID) Annual Meeting in Portland, Oregon, and at the
27th European Congress of Clinical Microbiology and Infectious
Diseases (ECCMID), in Vienna, Austria.
Second Quarter 2017 Financial Results
• Cash, cash equivalents and short-term investments
totaled $78.0 million as of June 30, 2017, compared with $90.1
million as of March 31, 2017 and $104.6 million as of December 31,
2016.
• Research and development expenses were $13.2 million and
$23.4 million for the three and six months ended June 30, 2017,
respectively, compared to $8.5 million and $15.7 million for the
same periods in 2016. The increase was primarily attributable to
the escalation of clinical development activities for CD101 IV.
• General and administrative expenses were $3.4 million
and $6.6 million for the three and six months ended June 30, 2017,
compared to $3.4 million and $6.1 million for the same periods in
2016. The increase was primarily due to higher personnel-related
costs to support the growth of operating activities.
• Net loss for the three months ended June 30, 2017 was
$16.6 million, compared to a net loss of $11.8 million for the
second quarter of 2016. For the six months ended June 30, 2017 and
2016, the company’s net loss was $30.0 million and $21.5 million,
respectively.
• As of July 31, 2017, Cidara had 16,863,095 common
shares outstanding.
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 improved
pharmacokinetics compared to existing echinocandins and has the
potential for expanded utility across patient settings. CD101 IV is
the only once-weekly product candidate in development 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 has received a grant for up to
$6.9 million from CARB-X (Combating Antibiotic Resistant Bacteria
Accelerator) to advance the development of CD201. 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 CD101 and CD201
and other potential product candidates, including the potential for
these compounds to successfully treat or prevent infections,
including those caused by resistant pathogens, and potentially
transform the way infectious diseases are treated, 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-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.
|
Cidara Therapeutics, Inc. |
Condensed Consolidated Balance
Sheets |
|
|
|
|
|
|
|
June 30, 2017 |
|
December 31, 2016 |
(In
thousands) |
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
Cash, cash equivalents,
and short-term investments |
|
$ |
78,012 |
|
|
$ |
104,619 |
|
Other current
assets |
|
1,791 |
|
|
779 |
|
Non-current assets |
|
1,355 |
|
|
1,564 |
|
Total assets |
|
$ |
81,158 |
|
|
$ |
106,962 |
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
Total liabilities |
|
$ |
19,894 |
|
|
$ |
18,783 |
|
Stockholders'
equity |
|
61,264 |
|
|
88,179 |
|
Total liabilities and
stockholders' equity |
|
$ |
81,158 |
|
|
$ |
106,962 |
|
|
|
|
|
|
|
|
|
|
|
Cidara Therapeutics, Inc. |
Condensed Consolidated Statements of
Operations |
(unaudited) |
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
(In thousands,
except share and per share data) |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
$ |
13,191 |
|
|
$ |
8,471 |
|
|
$ |
23,434 |
|
|
$ |
15,660 |
|
General
and administrative |
|
3,424 |
|
|
3,391 |
|
|
6,579 |
|
|
6,087 |
|
Total operating
expenses |
|
16,615 |
|
|
11,862 |
|
|
30,013 |
|
|
21,747 |
|
Loss from
operations |
|
(16,615 |
) |
|
(11,862 |
) |
|
(30,013 |
) |
|
(21,747 |
) |
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest
income (expense), net |
|
(30 |
) |
|
107 |
|
|
(30 |
) |
|
203 |
|
Total other income
(expense) |
|
(30 |
) |
|
107 |
|
|
(30 |
) |
|
203 |
|
Net loss |
|
$ |
(16,645 |
) |
|
$ |
(11,755 |
) |
|
$ |
(30,043 |
) |
|
$ |
(21,544 |
) |
Basic and diluted net
loss per share |
|
$ |
(0.99 |
) |
|
$ |
(0.85 |
) |
|
$ |
(1.79 |
) |
|
$ |
(1.56 |
) |
Shares used to compute
basic and diluted net loss per share |
|
16,831,960 |
|
|
13,871,938 |
|
|
16,813,759 |
|
|
13,839,864 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTOR CONTACT:
Robert H. Uhl
Westwicke Partners, LLC
Managing Director
(858) 356-5932
Robert.Uhl@westwicke.com
MEDIA CONTACT:
Christy Curran
Sam Brown Inc.
(615) 414-8668
ChristyCurran@sambrown.com
Cidara Therapeutics (NASDAQ:CDTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Cidara Therapeutics (NASDAQ:CDTX)
Historical Stock Chart
From Apr 2023 to Apr 2024