SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 9, 2019
Cidara Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
(State or Other Jurisdiction of
Incorporation or Organization)
(Commission File Number)
6310 Nancy Ridge Drive, Suite 101
San Diego, California 92121
(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))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange on which registered
Common Stock, Par Value $0.0001 Per Share
The Nasdaq Global Market
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 May 9, 2019, we issued a press release reporting our financial results for the three months ended March 31, 2019. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
In accordance with General Instruction B-2 of Form 8-K, the information contained or incorporated herein, including the press release filed as Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.
Item 9.01 Financial Statements and Exhibits.
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.
Date: May 9, 2019
/s/ Jeffrey L. Stein
Jeffrey L. Stein
President and Chief Executive Officer
(Principal Executive Officer)
FOR IMMEDIATE RELEASE
Cidara Provides Corporate Update and Reports
First Quarter 2019 Financial Results
SAN DIEGO, May 9, 2019 - Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today reported financial results for the three months ended March 31, 2019 and provided an update on its corporate activities and product pipeline.
"Cidara made significant progress to begin 2019 by continuing to enroll patients in and advance our global Phase 3 ReSTORE trial of rezafungin for the treatment of patients with candidemia and invasive candidiasis," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “In addition, we nominated CB-012 as the first development candidate from our novel Cloudbreak® antiviral program targeting influenza. We have also remained active in presenting new data at key medical meetings from our rezafungin and Cloudbreak programs as they both continue to progress."
First Quarter 2019 and Subsequent Highlights
Presented new data from multiple rezafungin studies at ECCMID 2019: In April 2019, Cidara presented new data from multiple studies of rezafungin, during the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting. Three oral presentations at ECCMID showcased results from nonclinical and in vivo studies that demonstrated the potential of rezafungin to fight and protect against difficult-to-treat fungal infections. Additionally, researchers presented five rezafungin posters at the meeting, including new analyses from Cidara’s Phase 2 STRIVE trial investigating rezafungin for the treatment of candidemia and invasive candidiasis.
Selected first clinical development candidate from Cloudbreak influenza program: In April 2019, Cidara selected the antiviral conjugate (AVC) CB-012 as its first clinical development candidate from the company’s Cloudbreak influenza (antiviral) program. CB-012 is a novel conjugate of a highly potent antiviral agent linked to a human antibody fragment. Applying the principles of oncology immunotherapy, Cidara’s Cloudbreak AVCs attack influenza through a dual mechanism: the antiviral agent neutralizes the influenza virus directly, while the human antibody fragment engages a patient’s immune system to accelerate elimination of the pathogen.
Presented preclinical data on CB-012 at ECCMID 2019: In April 2019, Cidara presented results from nonclinical studies, which evaluated the potential of CB-012 for the treatment and prevention of seasonal and pandemic influenza A as well as influenza B. The presentation described CB-012’s potent antiviral activity against influenza A and B viruses.
Presented rezafungin data at the 2019 TCT and EBMT Meetings: In February 2019, data from studies of rezafungin were presented at the 2019 Transplantation and Cellular Therapy (TCT) Meeting of ASBMT and CIBMTR in Houston and in March 2019, data from studies of rezafungin were presented at the 2019 Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in Frankfurt, Germany. The presentations highlighted the potential advantages of rezafungin for the prevention of invasive fungal infections in blood and marrow transplant patients.
First Quarter 2019 Financial Results
Cash, cash equivalents and short-term investments totaled $57.4 million as of March 31, 2019, compared with $74.6 million as of December 31, 2018.
As of April 30, 2019, Cidara had 26,641,851 shares of common stock outstanding, and 565,231 shares of Series X convertible preferred stock outstanding, which are convertible into 5,652,310 shares of common stock.
Research and development expenses were $12.7 million for the three months ended March 31, 2019, compared to $13.2 million for the same period in 2018. The decrease was primarily attributable to clinical development activities for rezafungin.
General and administrative expenses were $3.7 million for the three months ended March 31, 2019, compared to $3.6 million for the same period in 2018.
Net loss for the three months ended March 31, 2019 was $16.6 million, compared to a net loss of $16.7 million for the first quarter of 2018.
Rezafungin is a novel antifungal echinocandin being developed as a once-weekly, high-exposure therapy for the treatment and prevention of serious invasive fungal infections. Rezafungin has a unique pharmacokinetic profile with a prolonged half-life and front-loaded plasma exposure which, in contrast to all other echinocandins, allows for once-weekly IV therapy. Rezafungin is being developed to address unmet needs in the treatment of candidemia and invasive candidiasis as well as for prophylaxis (prevention) of invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation.
About Cidara Therapeutics
Cidara is a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel anti-infectives that have the potential to transform the standard of care and save or improve patients’ lives. Cidara is currently advancing its novel echinocandin antifungal, rezafungin acetate, in a Phase 3 clinical trial for the treatment of candidemia and invasive candidiasis, and is seeking funding to complete its rezafungin development plans including funding necessary for completion of the first Phase 3 treatment trial and to commence a second Phase 3 trial in the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation. Rezafungin is the only once-weekly product candidate in development for the treatment and prevention of life-threatening invasive fungal infections. Cidara also is leveraging its proprietary Cloudbreak® platform to develop antiviral conjugates (AVCs) for serious infections, including further investigation of the high potency and long half-life observed in its AVCs for influenza. The Cloudbreak platform is designed to discover compounds that both directly kill pathogens and direct a patient’s immune system to attack and eliminate pathogens. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
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, the potential for rezafungin to successfully treat or prevent invasive fungal infections and represent an improvement over current approaches, the potential for rezafungin in high-risk patient populations and Cidara’s ability to successfully develop rezafungin. Risks that contribute to the uncertain nature of the forward-looking statements include: Cidara’s ability to obtain additional financing; 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 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.
Cidara Therapeutics, Inc.
Condensed Consolidated Balance Sheets
March 31, 2019
December 31, 2018
Cash, cash equivalents, and short-term investments
Other current assets
LIABILITIES AND STOCKHOLDERS' EQUITY
Total liabilities and stockholders' equity
Cidara Therapeutics, Inc.
Condensed Consolidated Statements of Operations
Three Months Ended
(In thousands, except share and per share data)
Research and development
General and administrative
Total operating expenses
Loss from operations
Other income (expense):
Change in fair value of contingent forward purchase obligations
Interest income, net
Total other income (expense)
Net loss attributable to common shareholders
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Robert H. Uhl
Sam Brown Inc.