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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 21, 2017
CIDARA THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware
001-36912
46-1537286
(State of Incorporation)
(Commission File Number)
(IRS Employer Identification No.)
6310 Nancy Ridge Drive, Suite 101
San Diego, California 92121
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code: (858) 752-6170
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01
Regulation FD Disclosure
On February 21, 2017, Cidara Therapeutics, Inc. (the “Company”) issued a press release relating to the results of its Phase 2 clinical
trial of CD101 topical, called the RADIANT study. A copy of the press release is attached as Exhibit 99.1 to this report.
The information contained in this Item 7.01 and in Exhibit 99.1 of this Current Report on Form 8-K shall not be deemed “filed” for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any
filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a
filing.
Item 8.01
Other Events
On February 21, 2017, the Company reported results from its Phase 2 clinical trial of CD101 topical, called the RADIANT study,
which was designed to evaluate gel and ointment topical formulations of CD101 in women with moderate-to-severe acute
vulvovaginal candidiasis (“VVC”).
The RADIANT study was a multicenter, randomized, open-label, active-controlled, dose-ranging trial that enrolled 125 patients into
three treatment cohorts. In the first cohort, 50 patients were treated with CD101 gel; a second cohort of 50 patients was treated with
CD101 ointment. The third cohort comprised 25 patients treated with oral fluconazole.
The study found that while the gel and ointment topical formulations of CD101 were well tolerated, both formulations were similar in
efficacy to each other but lower in clinical and mycological cure rates compared to oral fluconazole. As a result, the Company has
discontinued the CD101 topical development program for VVC.
Item 9.01.
Financial Statements and Exhibits
(d) Exhibits.
Exhibit
No.
Description
99.1
Press Release, dated February 21, 2017.
1
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
Dated: February 21, 2017
IGNYTA, INC.
By:
Name:
Title:
2
/s/ Jeffrey Stein, Ph.D.
Jeffrey Stein, Ph.D.
President and Chief Executive Officer
EXHIBIT INDEX
Exhibit
No.
Description
99.1
Press Release, dated February 21, 2017.
3
Exhibit 99.1
FOR IMMEDIATE RELEASE
Cidara Therapeutics Reports Unfavorable Results of
Phase 2 RADIANT Trial of CD101 Topical in VVC
Further Development of CD101 Topical for VVC to be discontinued
CD101 IV development program in candidemia and invasive candidiasis
(including Phase 2 STRIVE trial) continuing and remains on track
Company to Host Conference Call Today at 5:30 a.m. PT
SAN DIEGO, February 21, 2017 – Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel
anti-infectives including immunotherapies, today reported that the randomized, controlled Phase 2 RADIANT clinical trial in acute
vulvovaginal candidiasis (VVC) did not show sufficient efficacy to justify further development of the tested topical formulations.
RADIANT was designed to evaluate gel and ointment topical formulations of the novel echinocandin antifungal CD101 in women
with moderate-to-severe acute VVC.
The study found that the gel and ointment topical formulations of CD101 evaluated in RADIANT were similar in efficacy to each
other but lower in clinical and mycological cure rates compared to oral fluconazole.
“We are obviously disappointed with these results, which did not demonstrate the highly potent antifungal properties of CD101
against Candida we saw in preclinical animal models of VVC. While we believe that an improved topical formulation of CD101
could improve outcomes, at this time we have no plans for futher development of CD101 topical in VVC,” said Jeffrey Stein, Ph.D.,
president and chief executive officer of Cidara. “We would like to thank the investigators and the patients who participated in this
trial. This does not impact our development of CD101 IV for the treatment of candidemia and invasive candidiasis, for which animal
models are well established and highly predictive of clinical outcomes.”
The discontinuation of the CD101 topical development program for VVC will enable Cidara to shift resources to other promising
product candidates currently in its portfolio, including CD101 IV, currently being studied in Phase 2 for candidemia, and the
expansion and acceleration of the Cloudbreak immunotherapy platform, including CD201 for the treatment of infections caused by
multi-drug resistant Gram-negative bacteria.
RADIANT was a multicenter, randomized, open-label, active-controlled, dose-ranging trial that enrolled 125 patients into three
treatment cohorts. In the first cohort, 50 patients were treated with CD101 Gel; a second cohort of 50 patients was treated with CD101
Ointment. The third cohort comprised 25 patients treated with oral fluconazole. The trial included women with and without a history
of recurrent VVC (RVVC). A table of topline results is included below.
Topline Key Clinical and Microbiological Cure Rates in the mITT* Population
Clinical Cure Day 7
(Cure defined as VSS**=0)
Clinical Cure Day 7
(Cure defined as VSS** 2)
Mycologic Cure Day 28
*
**
CD101 Topical Gel
(n=40)
CD101 Topical
Ointment (n=40)
Fluconazole
(n=19)
37.5%
40.0%
47.4%
57.5%
45.0%
62.5%
40.0%
78.9%
57.9%
mITT population: Subjects who received at least one dose of study drug with a positive vaginal culture for Candida species and
no coinfection with other vaginal or cervical infections at screening.
Vaginal Scoring System (VSS): a scale used to determine VVC severity based on a scale of 0 (absent) to 3 (severe) for each of 6
signs and symptoms for a maximum score of 18.
CD101 Gel and Ointment were well-tolerated. The number of patients with at least one treatment emergent adverse event (TEAE)
considered related to study drug by the investigator were two, four and zero in the CD101 Gel, CD101 Ointment and fluconazole
arms, respectively. There were no serious adverse events reported in any treatment arm.
About CD101 IV
CD101 IV has enhanced potency and is the only once-weekly therapy intended for the treatment and prevention of life-threatening
invasive fungal infections. Cidara’s international Phase 2 clinical trial of CD101 IV in candidemia, the STRIVE trial, remains on
track. The STRIVE trial is a double-blind trial comparing the safety and efficacy of once weekly CD101 IV to standard-of-care
therapy, caspofungin, with an optional step-down to oral fluconazole. As primary endpoints, the trial will measure mycological
eradication and resolution of systemic signs attributable to candidemia at day 14. Results from this trial are expected during the fourth
quarter of 2017.
Conference Call and Webcast
Management will host a conference call and webcast at 5:30 am Pacific Time today. To participate in the conference call by
telephone, please dial 844-358-8763 and refer to conference ID 75165690. The webcast will be made available on Cidara’s website at
www.cidara.com under the Investors tab in the Events section. Following the live audio webcast, a replay will be available on
Cidara’s website for approximately 30 days.
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 antimicrobial 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 related to the progress and timing of Cidara’s drug discovery and development programs, including the
application of additional resources to the CD101 IV and Cloudbreak programs; the potential for CD101 IV to be a safe and effective
treatment option for serious invasive fungal infections; and the potential for CD201 to be a safe and effective treatment option for the
treatment of infections caused multi-drug resistant Gram negative bacteria. 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.
INVESTOR CONTACT:
Robert H. Uhl
Westwicke Partners, LLC
Managing Director
(858) 356-5932
[email protected]
MEDIA CONTACT:
Christy Curran
Sam Brown Inc.
(615) 414-8668
[email protected]
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