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Cidara Reports Second Quarter 2015 Financial Results and Provides Corporate Update
Second Quarter 2015 and Subsequent Highlights
Initiated Phase 1 Study of Lead Antifungal Product Candidate CD101 IV: In August, Cidara announced the initiation of a Phase 1, randomized, double-blind, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of CD101 IV in healthy subjects.
16 Posters Across Three Programs to be Presented at ICAAC: In August, Cidara announced plans to present additional preclinical data at the
Interscience Conference on Antimicrobial Agents and Chemotherapy(ICAAC) conference in September 2015.
Joined Russell Indexes: In June, Cidara was added to the Russell 3000®, Russell 2000®, and Russell Microcap® Indexes.
Granted Qualified Infectious Disease Product (QIDP) and Fast Track Designations for CD101 IV by
FDA: In May, 2015, Cidara announced that the U.S. Food and Drug Administration( FDA) had designated its lead antifungal product candidate, CD101 IV, as a Qualified Infectious Disease Product (QIDP) with Fast Track status. The QIDP and Fast Track designations are for the use of CD101 IV in the treatment of candidemia and invasive candidiasis.
Successfully Completed Initial Public Offering: In April, Cidara priced its initial public offering of 4,800,000 shares of common stock at a public offering price of
$16.00per share. Proceeds from the offering, net of underwriting discounts, commissions and offering-related transaction costs, were $69.3 million.
"This year has proven to be transformational for Cidara," said
Cash and cash equivalents totaled
$122.3 millionas of June 30, 2015, compared with $58.1 millionas of March 31, 2015. The second quarter figure includes net proceeds from the initial public offering of $69.3 million.
Research and development expenses were
$4.2 millionand $9.1 millionfor the three and six months ended June 30, 2015, respectively, compared to $1.0 millionand $1.2 millionfor the same periods in 2014. The increases for the 2015 periods, as compared to the same periods in 2014, were primarily attributable to the expansion of the company's product candidate pipeline to include CD101 IV and CD101 topical and the personnel-related costs associated with hiring our workforce.
General and administrative expenses were
$2.2 millionand $4.0 millionfor the three and six months ended June 30, 2015, respectively, compared to $0.5 millionand $0.8 millionfor the same periods in 2014. The increases resulted primarily from personnel-related costs to support the growth of our operating activities as well as the costs associated with operating as a public company.
Net loss for the three months ended
June 30, 2015was $6.4 million, compared to a net loss of $3.2 millionfor the second quarter of 2014. For the six months ended June 30, 2015, the net loss was $13.2 million, compared to $3.9 millionfor the comparable period in 2014.
August 10, 2015, Cidara had 13,674,291 common shares outstanding.
Cidara is a clinical stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives for the treatment of diseases that are inadequately addressed by current standard-of-care therapies. Cidara's initial product portfolio comprises two formulations of the company's novel echinocandin, CD101, for the treatment of serious fungal infections. CD101 IV is a long-acting therapy for the treatment and prevention of systemic fungal infections, and CD101 topical is for the treatment of vulvovaginal candidiasis (VVC) and recurrent VVC (RVVC), a prevalent mucosal infection. In addition, Cidara has developed a proprietary immunotherapy platform, Cloudbreak™, designed to create compounds that direct a patient's immune cells to attack and eliminate pathogens that cause infectious disease. Cidara is headquartered in
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effectiveness and long-acting nature of CD101 IV and the intended design of current and future Cloudbreak compounds. Risks that contribute to the uncertain nature of the forward-looking statements include: the success and timing of Cidara's preclinical studies and clinical trials; regulatory developments in
Cidara Therapeutics, Inc.
Condensed Balance Sheets
|(In thousands, except share and per share amounts)||(unaudited)|
|Cash and cash equivalents||$ 122,301||$ 22,796|
|Prepaid expenses and other current assets||749||217|
|Total current assets||123,050||23,013|
|Property and equipment, net||831||863|
|Total assets||$ 123,953||$ 24,350|
|LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY (DEFICIT)|
|Accounts payable||$ 854||$ 1,177|
|Accrued compensation and benefits||755||414|
|Total current liabilities||3,068||3,213|
|Other long-term liabilities||28||34|
|Commitments and contingencies|
|Series A convertible preferred stock, $0.0001 par value; no shares authorized, issued and outstanding at June 30, 2015; 127,214,000 shares authorized and 97,526,081 shares issued and outstanding at December 31, 2014||--||32,548|
|Stockholders' equity (deficit):|
|Preferred stock, $0.0001 par value; 10,000,000 shares authorized at June 30, 2015; no shares authorized at December 31, 2014; no shares issued or outstanding at June 30, 2015 and December 31, 2014||--||--|
|Common stock, $0.0001 par value; 200,000,000 and 185,000,000 shares authorized at June 30, 2015 and December 31, 2014, respectively; 13,903,536 and 13,598,693 shares issued and outstanding, respectively, at June 30, 2015; 1,494,506 and 1,132,738 shares issued and outstanding, respectively, at December 31, 2014||4||3|
|Additional paid-in capital||147,308||1,856|
|Total stockholders' equity (deficit)||120,857||(11,445)|
|Total liabilities, convertible preferred stock, and stockholders' equity (deficit)||$ 123,953||$ 24,350|
Cidara Therapeutics, Inc.
Condensed Statements of Operations
Three months ended
Six months ended
|(In thousands, except share and per share data)||2015||2014||2015||2014|
|Research and development||$ 4,210||$ 966||$ 9,145||$ 1,244|
|Cost of in-process research and development acquired||--||1,607||--||1,607|
|General and administrative||2,236||522||4,033||803|
|Total operating expenses||6,446||3,095||13,178||3,654|
|Loss from operations||(6,446)||(3,095)||(13,178)||(3,654)|
|Other income (expense):|
|Interest income (expense), net||32||(44)||27||(89)|
|Change in fair value of convertible notes payable||--||(80)||--||(183)|
|Total other income (expense)||32||(124)||27||(272)|
|Net loss||$ (6,414)||$ (3,219)||$ (13,151)||$ (3,926)|
|Net loss per common share, basic and diluted||$ (0.59)||$ (5.04)||$ (2.16)||$ (7.63)|
|Weighted average shares outstanding used to compute net loss per share, basic and diluted||10,957,150||638,272||6,075,134||514,736|
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