0001564590-15-006996.txt : 20150811 0001564590-15-006996.hdr.sgml : 20150811 20150811160515 ACCESSION NUMBER: 0001564590-15-006996 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20150811 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20150811 DATE AS OF CHANGE: 20150811 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Cidara Therapeutics, Inc. CENTRAL INDEX KEY: 0001610618 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 461537286 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36912 FILM NUMBER: 151043934 BUSINESS ADDRESS: STREET 1: 6310 NANCY RIDGE DRIVE STREET 2: SUITE 101 CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 858-752-6170 MAIL ADDRESS: STREET 1: 6310 NANCY RIDGE DRIVE STREET 2: SUITE 101 CITY: SAN DIEGO STATE: CA ZIP: 92121 FORMER COMPANY: FORMER CONFORMED NAME: K2 THERAPEUTICS, INC. DATE OF NAME CHANGE: 20140611 8-K 1 cdtx-8k_20150811.htm 8-K cdtx-8k_20150811.htm

 

 

 

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): August 11, 2015

 

 

Cidara Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware

 

001-36912

 

46-1537286

(State or Other Jurisdiction of

Incorporation or Organization)

 

(Commission File Number)

 

(I.R.S. Employer

Identification Number)

 

6310 Nancy Ridge Drive, Suite 101

San Diego, California 92121

(858) 752-6170

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations 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))

 

 

 

 


 

 

In this report, “Cidara Therapeutics,” “Cidara,” “Company,” “we,” “us” and “our” refer to Cidara Therapeutics, Inc.

Item 2.02 Results of Operations and Financial Condition.

On August 11, 2015, we issued a press release reporting our financial results for the second quarter ended June 30, 2015.  The full text of the press release is furnished as exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

 

 

 

Exhibit No.

  

Description

 

 

99.1

  

Press release issued August 11, 2015, reporting financial results for the second quarter ended June 30, 2015.

 

 

2


 

 

SIGNATURES

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.

 

 

Cidara Therapeutics, Inc.

 

 

 

 

 

Dated: August 11, 2015

By:

 

/s/ Jeffrey L. Stein

 

 

 

 

Jeffrey L. Stein

 

 

 

 

President and Chief Executive Officer

(Principal Executive Officer)

 

3


 

 

INDEX TO EXHIBITS

 

 

 

 

 

Exhibit No.

  

Description

 

 

99.1

  

Press release issued August 11, 2015, reporting financial results for the second quarter ended June 30, 2015.

 

 

 

4

EX-99.1 2 cdtx-ex991_15.htm EX-99.1: Q2 2015 EARNINGS RELEASE cdtx-ex991_15.htm

Exhibit 99.1

 

 

FOR IMMEDIATE RELEASE

 

Cidara Reports Second Quarter 2015 Financial Results and Provides Corporate Update

 

SAN DIEGO, August 11, 2015 – Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today reported financial results for the three and six months ended June 30, 2015 and provided an update on its corporate activities and product pipeline.

 

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 $16.00 per 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 Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “Of particular note were the completion of our initial public offering and the initiation of the company’s first clinical trial for our novel anti-fungal CD101

 


Exhibit 99.1

IV, which has received QIDP and Fast Track designations from the FDA. We look forward to building on this strong momentum in the second half of 2015.

 

Financial Results

 

·

Cash and cash equivalents totaled $122.3 million as of June 30, 2015, compared with $58.1 million as 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 million and $9.1 million for the three and six months ended June 30, 2015, respectively, compared to $1.0 million and $1.2 million for 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 million and $4.0 million for the three and six months ended June 30, 2015, respectively, compared to $0.5 million and $0.8 million for 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, 2015 was $6.4 million, compared to a net loss of $3.2 million for the second quarter of 2014. For the six months ended June 30, 2015, the net loss was $13.2 million, compared to $3.9 million for the comparable period in 2014.

 

·

As of August 10, 2015, Cidara had 13,674,291 common shares outstanding.

 

 

About Cidara Therapeutics

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 San Diego, California.  For more information please visit www.cidara.com.

 


Exhibit 99.1

 

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 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 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 documents most recently filed with the United States Securities and Exchange Commission (SEC), including its Registration Statement on Form S-1 declared effective by the SEC on April 14, 2015, under the heading "Risk Factors." 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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Exhibit 99.1

Cidara Therapeutics, Inc.

Condensed Balance Sheets

 

June 30,

2015

 

 

December 31,

2014

 

(In thousands, except share and per share amounts)

(unaudited)

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

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

 

Other assets

 

72

 

 

 

474

 

Total assets

$

123,953

 

 

$

24,350

 

 

 

 

 

 

 

 

 

LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY (DEFICIT)

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

854

 

 

$

1,177

 

Accrued liabilities

 

1,459

 

 

 

1,622

 

Accrued compensation and benefits

 

755

 

 

 

414

 

Total current liabilities

 

3,068

 

 

 

3,213

 

Other long-term liabilities

 

28

 

 

 

34

 

Total liabilities

 

3,096

 

 

 

3,247

 

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

 

Accumulated deficit

 

(26,455

)

 

 

(13,304

)

Total stockholders' equity (deficit)

 

120,857

 

 

 

(11,445

)

Total liabilities, convertible preferred stock, and stockholders' equity (deficit)

$

123,953

 

 

$

24,350

 

 


Exhibit 99.1

Cidara Therapeutics, Inc.

Condensed Statements of Operations

 

 

Three months ended

June 30,

 

 

Six months ended

June 30,

 

(In thousands, except share and per share data)

2015

 

 

2014

 

 

2015

 

 

2014

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

INVESTOR CONTACT:

Robert H. Uhl

Westwicke Partners, LLC

Managing Director

(858) 356-5932

robert.uhl@westwicke.com

 

MEDIA CONTACT:

Mike Beyer

Sam Brown Inc.

(312) 961-2502

mikebeyer@sambrown.com

 

###

 

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