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Cidara Provides Corporate Update and Reports Fourth Quarter and Full Year 2016 Financial Results
“Cidara continued to make progress throughout the year in moving our development programs forward,” said
Fourth Quarter 2016 and Subsequent Highlights
$20 MillionCredit Facility: In October 2016, Cidara entered into an agreement for a $20 millioncredit facility with Pacific Western Bank. Proceeds from the facility provide working capital to support the CD101 and CD201 programs, which are in development to treat serious fungal and multi-drug resistant bacterial infections.
- Completed Follow-on Public Offering: In
October 2016, Cidara successfully completed a follow-on public offering of 2,475,248 shares of common stock, plus 277,389 shares sold upon the partial exercise of the underwriters’ option to purchase additional shares, at a price to the public of $10.10per share. Proceeds from the offering were $27.8 million, before deducting underwriting discounts, commissions and offering expenses.
- Reported Results of Phase 2 RADIANT Trial of CD101 Topical in Vulvovaginal Candidiasis: In
February 2017, Cidara 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.
Fourth Quarter and Full Year 2016 Financial Results
- Cash, cash equivalents and short-term investments totaled
$104.6 millionas of December 31, 2016, which includes the proceeds from the October follow-on offering and draw-down from the credit facility, compared with $79.3 millionas of September 30, 2016and $107.5 millionas of December 312015.
- As of
February 28, 2017, Cidara had 16,801,184 common shares outstanding.
- Research and development expenses were
$11.3 millionand $35.7 millionfor the three months and full year ended December 31, 2016, respectively, compared to $7.6 millionand $23.5 millionfor the same periods in 2015. The increases were primarily attributable to clinical development activities for CD101 IV and CD101 topical, as well as preclinical development activities for CD201 and our Cloudbreak platform.
- General and administrative expenses were
$3.0 millionand $12.7 millionfor the three months and full year ended December 31, 2016, respectively, compared to $2.3 millionand $8.8 millionfor the same periods in 2015. The increase resulted primarily from personnel-related costs to support the growth of our operating activities in addition to costs to operate as a public company.
- Net loss for the three months ended
December 31, 2016was $14.4 million, compared to a net loss of $9.9 millionfor the fourth quarter of 2015. For the full year ended December 31, 2016and 2015, the company reported a net loss of $48.2 millionand $32.2 million, respectively.
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, through a Phase 2 study 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
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, anticipated human dosing and other attributes of CD101, including the potential for CD101 to treat infections and the timing of the completion of the STRIVE study, as well as the potential for CD201 to successfully treat bacterial infections and complete IND-enabling studies, 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
|Cidara Therapeutics, Inc.|
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents, and short-term investments||$||104,619||$||107,514|
|Other current assets||779||704|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Total liabilities and stockholders' equity||$||106,962||$||109,974|
|Cidara Therapeutics, Inc.|
|Condensed Consolidated Statements of Operations|
|Three months ended
|(In thousands, except share and per share data)||2016||2015||2016||2015|
|Research and development||$||11,310||$||7,564||$||35,699||$||23,475|
|General and administrative||3,043||2,364||12,737||8,838|
|Total operating expenses||14,353||9,928||48,436||32,313|
|Loss from operations||(14,353||)||(9,928||)||(48,436||)||(32,313||)|
|Other income (expense):|
|Interest income (expense), net||(41||)||60||271||120|
|Total other income (expense)||(41||)||60||271||120|
|Basic and diluted net loss per share||$||(0.88||)||$||(0.72||)||$||(3.32||)||$||(3.25||)|
|Shares used to compute basic and diluted net loss per share||16,352,046||13,731,519||14,488,987||9,920,382|
Robert H. Uhl Westwicke Partners, LLCManaging Director (858) 356-5932 email@example.com MEDIA CONTACT: Christy Curran Sam Brown Inc.(615) 414-8668 ChristyCurran@sambrown.com