Cidara Provides Corporate Update and Reports First Quarter 2019 Financial Results
May 09 2019 - 4:13PM
Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company
developing novel anti-infectives including immunotherapies, today
reported financial results for the three months ended
March 31, 2019 and provided an update on its corporate
activities and product pipeline.
"Cidara made significant progress to begin 2019 by continuing to
enroll patients in and advance our global Phase 3 ReSTORE trial of
rezafungin for the treatment of patients with candidemia and
invasive candidiasis," said Jeffrey Stein, Ph.D., president and
chief executive officer of Cidara. “In addition, we nominated
CB-012 as the first development candidate from our novel
Cloudbreak® antiviral program targeting influenza. We have also
remained active in presenting new data at key medical meetings from
our rezafungin and Cloudbreak programs as they both continue to
progress."
First Quarter 2019 and Subsequent
Highlights
- Presented new data from multiple rezafungin studies at
ECCMID 2019: In April 2019, Cidara presented new data from
multiple studies of rezafungin, during the 29th European Congress
of Clinical Microbiology and Infectious Diseases (ECCMID) meeting.
Three oral presentations at ECCMID showcased results from
nonclinical and in vivo studies that demonstrated the potential of
rezafungin to fight and protect against difficult-to-treat fungal
infections. Additionally, researchers presented five rezafungin
posters at the meeting, including new analyses from Cidara’s Phase
2 STRIVE trial investigating rezafungin for the treatment of
candidemia and invasive candidiasis.
- Selected first clinical development candidate from
Cloudbreak influenza program: In April 2019, Cidara
selected the antiviral conjugate (AVC) CB-012 as its first clinical
development candidate from the company’s Cloudbreak influenza
(antiviral) program. CB-012 is a novel conjugate of a highly potent
antiviral agent linked to a human antibody fragment. Applying the
principles of oncology immunotherapy, Cidara’s Cloudbreak AVCs
attack influenza through a dual mechanism: the antiviral agent
neutralizes the influenza virus directly, while the human antibody
fragment engages a patient’s immune system to accelerate
elimination of the pathogen.
- Presented preclinical data on CB-012 at ECCMID
2019: In April 2019, Cidara presented results from
nonclinical studies, which evaluated the potential of CB-012 for
the treatment and prevention of seasonal and pandemic influenza A
as well as influenza B. The presentation described CB-012’s potent
antiviral activity against influenza A and B viruses.
- Presented rezafungin data at the 2019 TCT and EBMT
Meetings: In February 2019, data from studies of
rezafungin were presented at the 2019 Transplantation and Cellular
Therapy (TCT) Meeting of ASBMT and CIBMTR in Houston and in March
2019, data from studies of rezafungin were presented at the 2019
Annual Meeting of the European Society for Blood and Marrow
Transplantation (EBMT) in Frankfurt, Germany. The presentations
highlighted the potential advantages of rezafungin for the
prevention of invasive fungal infections in blood and marrow
transplant patients.
First Quarter 2019 Financial Results
- Cash, cash equivalents and short-term investments totaled $57.4
million as of March 31, 2019, compared with $74.6 million as
of December 31, 2018.
- As of April 30, 2019, Cidara had 26,641,851 shares of
common stock outstanding, and 565,231 shares of Series X
convertible preferred stock outstanding, which are convertible into
5,652,310 shares of common stock.
- Research and development expenses were $12.7 million for the
three months ended March 31, 2019, compared to $13.2 million
for the same period in 2018. The decrease was primarily
attributable to clinical development activities for
rezafungin.
- General and administrative expenses were $3.7 million for the
three months ended March 31, 2019, compared to $3.6 million
for the same period in 2018.
- Net loss for the three months ended March 31, 2019 was
$16.6 million, compared to a net loss of $16.7 million for the
first quarter of 2018.
About Rezafungin
Rezafungin is a novel antifungal echinocandin being developed as
a once-weekly, high-exposure therapy for the treatment and
prevention of serious invasive fungal infections. Rezafungin has a
unique pharmacokinetic profile with a prolonged half-life and
front-loaded plasma exposure which, in contrast to all other
echinocandins, allows for once-weekly IV therapy. Rezafungin is
being developed to address unmet needs in the treatment of
candidemia and invasive candidiasis as well as for prophylaxis
(prevention) of invasive fungal infections in patients undergoing
allogeneic blood and marrow transplantation.
About Cidara Therapeutics
Cidara is a clinical-stage biotechnology company focused on the
discovery, development and commercialization of novel
anti-infectives that have the potential to transform the standard
of care and save or improve patients’ lives. Cidara is currently
advancing its novel echinocandin antifungal, rezafungin acetate, in
a Phase 3 clinical trial for the treatment of candidemia and
invasive candidiasis, and is seeking funding to complete its
rezafungin development plans including funding necessary for
completion of the first Phase 3 treatment trial and to commence a
second Phase 3 trial in the prophylaxis of invasive fungal
infections in patients undergoing allogeneic blood and marrow
transplantation. Rezafungin is the only once-weekly product
candidate in development for the treatment and prevention of
life-threatening invasive fungal infections. Cidara also is
leveraging its proprietary Cloudbreak® platform to develop
antiviral conjugates (AVCs) for serious infections, including
further investigation of the high potency and long half-life
observed in its AVCs for influenza. The Cloudbreak platform is
designed to discover compounds that both directly kill pathogens
and direct a patient’s immune system to attack and eliminate
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, the potential for
rezafungin to successfully treat or prevent invasive fungal
infections and represent an improvement over current approaches,
the potential for rezafungin in high-risk patient populations and
Cidara’s ability to successfully develop rezafungin. Risks that
contribute to the uncertain nature of the forward-looking
statements include: Cidara's ability to obtain additional
financing; 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 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
|
March 31, 2019 |
|
December 31, 2018 |
(In
thousands) |
(unaudited) |
|
|
ASSETS |
|
|
|
Cash, cash equivalents, and
short-term investments |
$ |
57,407 |
|
|
$ |
74,562 |
|
Other current assets |
2,869 |
|
|
2,567 |
|
Non-current assets |
4,037 |
|
|
1,983 |
|
Total assets |
$ |
64,313 |
|
|
$ |
79,112 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
Total liabilities |
$ |
20,451 |
|
|
$ |
19,973 |
|
Stockholders' equity |
43,862 |
|
|
59,139 |
|
Total liabilities and
stockholders' equity |
$ |
64,313 |
|
|
$ |
79,112 |
|
Cidara Therapeutics,
Inc.Condensed Consolidated Statements of
Operations
(unaudited) |
Three Months Ended March 31, |
(In thousands, except
share and per share data) |
2019 |
|
2018 |
Operating expenses: |
|
|
|
Research and development |
$ |
12,669 |
|
|
$ |
13,199 |
|
General and administrative |
3,735 |
|
|
3,611 |
|
Total operating expenses |
16,404 |
|
|
16,810 |
|
Loss from operations |
(16,404 |
) |
|
(16,810 |
) |
Other income (expense): |
|
|
|
Change in fair value of contingent forward purchase
obligations |
(270 |
) |
|
— |
|
Interest income, net |
113 |
|
|
61 |
|
Total other income
(expense) |
(157 |
) |
|
61 |
|
Net loss attributable to
common shareholders |
$ |
(16,561 |
) |
|
$ |
(16,749 |
) |
Basic and diluted net loss per
common share |
$ |
(0.60 |
) |
|
$ |
(0.80 |
) |
Shares used to compute basic
and diluted net loss per common share |
27,729,977 |
|
|
20,894,353 |
|
INVESTOR CONTACT:Robert H. UhlWestwicke
IRManaging Director(858) 356-5932Robert.Uhl@westwicke.com
MEDIA CONTACT:Andrea CohenSam Brown Inc.(917)
209-7163andreacohen@sambrown.com
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