Business description of CIDARA-THERAPEUTICS-INC from last 10-k form

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K

(Mark One)

x

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2015

o

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM                      TO                     

Commission File Number 001-36912

CIDARA THERAPEUTICS, INC

(Exact name of Registrant as specified in its Charter)

Delaware

 

46-1537286

(State or Other Jurisdiction of

Incorporation or Organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

6310 Nancy Ridge Drive, Suite 101

San Diego, CA  92121

 

(858) 752-6170

(Address of Principal Executive Offices)

 

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act: Common Stock, Par Value $0.0001 Per Share; Common stock traded on the NASDAQ Global Market

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES o NO x

Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. YES o NO x

Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES x NO o

Indicate by check mark whether the Registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit and post such files). YES x NO o

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405) is not contained herein, and will not be contained, to the best of Registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. x

Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definition of “large accelerated filer”, “accelerated filer”, and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer

 

o

  

Accelerated filer

 

o

 

 

 

 

Non-accelerated filer

 

x  (Do not check if a small reporting company)

  

Small reporting company

 

o

Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES o NO x

The aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant, based on the closing price of the shares of common stock on The NASDAQ Global Market on June 30, 2015, was approximately $95.2 million.

The number of shares of Registrant’s Common Stock outstanding as of February 29, 2016 was 13,822,747.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the Registrant’s definitive Proxy Statement to be filed with the Securities and Exchange Commission pursuant to Schedule 14A in connection with the registrant’s 2016 Annual Meeting of Stockholders, which will be filed subsequent to the date hereof, are incorporated by reference into Part III of this Form 10-K.  Such definitive proxy statement will be filed with the Securities and Exchange Commission not later than 120 days following the end of the Registrant’s fiscal year ended December 31, 2015.

CIDARA THERAPEUTICS, INC.

Table of Contents

 

 

 

 

Page

PART I

 

 

 

 

Item 1.

 

 

3

Item 1A.

 

 

27

Item 1B.

 

 

54

Item 2.

 

 

54

Item 3.

 

 

54

Item 4.

 

 

54

 

 

 

 

 

PART II

 

 

 

 

Item 5.

 

 

55

Item 6.

 

 

57

Item 7.

 

 

58

Item 7A.

 

 

64

Item 8.

 

 

66

Item 9.

 

 

82

Item 9A.

 

 

82

Item 9B.

 

 

82

 

 

 

 

 

PART III

 

 

 

 

Item 10.

 

 

84

Item 11.

 

 

84

Item 12.

 

 

84

Item 13.

 

 

84

Item 14.

 

 

84

 

 

 

 

 

PART IV

 

 

 

 

Item 15.

 

 

85

 

 

 

 

 

SIGNATURES

 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Annual Report on Form 10-K contains forward-looking statements. We may, in some cases, use words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. Forward-looking statements in this Annual Report on Form 10-K include, but are not limited to, statements about:

 

·

our anticipated timing for preclinical development, regulatory submissions, commencement and completion of clinical trials and product approvals;

 

·

our plans to research, develop and commercialize our product candidates;

 

·

our ability to fund our working capital requirements;

 

·

our expected clinical trial designs and regulatory pathways;

 

·

our ability to obtain and maintain regulatory approval of our product candidates and any related restrictions, limitations, and/or warnings in the label of an approved product candidate;

 

·

our ability to successfully commercialize, and our expectations regarding future therapeutic and commercial potential with respect to, our product candidates;

 

·

the size and growth potential of the markets for our product candidates, and our ability to serve those markets;

 

·

the rate and degree of market acceptance of our products that are approved;

 

·

our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators;

 

·

regulatory developments in the United States and foreign countries;

 

·

the performance of our third-party suppliers and manufacturers;

 

·

the success of competing therapies that are or may become available;

 

·

our expectations for the attributes of our product and development candidates, including pharmaceutical properties, efficacy, safety and dosing regimens;

 

·

our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing;

 

·

our expectation that our existing capital resources will be sufficient to enable us to complete our planned clinical trials;

 

·

our ability to obtain and maintain intellectual property protection for our product candidates;

 

·

our ability to use our Cloudbreak immunotherapy platform to identify development candidates, or to expand our Cloudbreak immunotherapy platform to other areas of infective disease;

 

·

our ability to identify and develop new product candidates;

 

·

the potential for prophylactic use of any of our product candidates;

 

·

our ability to retain and recruit key personnel;

 

·

our financial performance; and

 

·

developments and projections relating to our competitors or our industry.