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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): April 22, 2024
 
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))

Securities registered pursuant to Section 12(b) of the Act:
Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, Par Value $0.0001 Per Share CDTX The Nasdaq Stock Market LLC

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 ☐
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. ☐



Item 2.02 Results of Operations and Financial Condition.
On April 22, 2024, Cidara Therapeutics, Inc. (the “Company”) issued a press release reporting its financial results for the fourth quarter and year ended December 31, 2023. 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 3.03 Material Modification to Rights of Security Holders.
As previously reported, on April 4, 2024, the Company held a special meeting of stockholders (the “2024 Special Meeting”) at which the Company’s stockholders approved a proposal to (i) amend the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock split of the Company’s outstanding common stock at a ratio in the range of 1-for-10 to 1-for-30, inclusive; and (ii) if and only if the reverse stock split is approved and implemented, a reduction in the number of authorized shares of common stock, at a ratio that is equal to half of the reverse stock split ratio, with such ratio to be determined in the discretion of the Company’s board of directors and with such reverse stock split to be effected at such time and date, if at all, as determined by the Company’s board of directors in its sole discretion.
On April 12, 2024, the Company’s board of directors approved a reverse stock split of the Company’s common stock at a ratio of 1-for-20. On April 22, 2024, the Company filed with the Secretary of State of the State of Delaware a Certificate of Amendment of its Amended and Restated Certificate of Incorporation (the “Charter Amendment”) to effect the 1-for-20 reverse stock split of the Company’s outstanding common stock. The Charter Amendment will be effective at 5:00 p.m. Eastern Time on April 23, 2024 (the “Effective Time”).
The Charter Amendment provides that, at the Effective Time, every twenty shares of the Company’s issued and outstanding common stock will automatically be combined into one issued and outstanding share of common stock, without any change in par value per share. As a result of the reverse stock split, proportionate adjustments will be made to the per share exercise price and/or the number of shares issuable upon the exercise or vesting of all stock options and warrants issued by the Company and outstanding immediately prior to the Effective Time, which will result in a proportionate decrease in the number of shares of the Company’s common stock reserved for issuance upon exercise or vesting of such stock options and warrants, and a proportionate increase in the exercise price of all such stock options and warrants. In addition, the number of shares authorized for future grant under the Company’s equity incentive/compensation plans immediately prior to the Effective Time will be reduced proportionately. At the Effective Time, the total number of the Company’s authorized shares of common stock will be 20,000,000.
The Company’s common stock will begin trading on the Nasdaq Capital Market on a split-adjusted basis when the market opens on April 24, 2024. The new CUSIP number for the Company’s common stock following the reverse stock split is 171757206.
The foregoing summary of the Charter Amendment is qualified in its entirety by reference to the Charter Amendment, which is attached to this Current Report on Form 8-K as Exhibit 3.1 and is incorporated herein by reference.
On April 22, 2024, the Company issued a press release announcing the reverse stock split. A copy of the press release is filed herewith as Exhibit 99.2 hereto.
Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year.
The information set forth in Item 3.03 of this Current Report on Form 8-K is incorporated by reference herein.




Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
 
Exhibit No. Description
3.1
99.1
99.2
104 Cover page Interactive Data File (embedded within the Inline XBRL document).



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.
     
Date: April 22, 2024   /s/ Jeffrey Stein, Ph.D.
      Jeffrey Stein, Ph.D.
      President and Chief Executive Officer
(Principal Executive Officer)


EX-99.1 2 ex991-2024x04x22.htm EARNINGS RELEASE Document
Exhibit 99.1
cidaralogoa.jpg
Cidara Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2023 Financial Results
SAN DIEGO, April 22, 2024 — Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided an update on its corporate activities and product pipeline.
“2023 included significant accomplishments throughout our business within both our Cloudbreak® drug-Fc conjugate (DFC) and our REZZAYO® (rezafungin) programs,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “With respect to our DFC platform, we continue to generate and present compelling data from our oncology programs as well as our CD388 influenza program partnered with Janssen. We have multiple key catalysts expected this year, including the filing of an Investigational New Drug Application (IND) in mid-2024 for CBO421, a potential best-in-class inhibitor of CD73. We recently presented promising new data on CD73/PD-1 multispecific DFC, CCR5-targeting DFC and CBO421 at the American Association for Cancer Research (AACR) Annual Meeting.”
Dr. Stein continued, “Most recently, REZZAYO was approved in the European Union (EU) and United Kingdom (UK) for the treatment of invasive candidiasis in adults, earning milestone payments of approximately $11.1 million and $2.8 million, respectively. In addition, enrollment was completed in the Phase 3 ReSTORE trial in China evaluating the efficacy and safety of rezafungin as a treatment for candidemia and invasive candidiasis, bringing us one step closer to making this important drug available to an even broader global patient population.”
Recent Corporate Highlights
•Presented at AACR Annual Meeting 2024: In April 2024, Cidara presented promising new data on novel Cloudbreak DFC candidates at the AACR Annual Meeting. The Company delivered four poster presentations highlighting the data on the Company’s multispecific CD73/PD-1 DFC, its CCR5-targeting DFC, and CBO421, its lead oncology DFC candidate targeting CD73.
•Presented at IDWeek 2023: In October 2023, Cidara presented new preclinical and clinical data on Novel Cloudbreak Influenza Drug-Fc Conjugate CD388 at IDWeek 2023.
•Presented at ESMO Immuno-Oncology Annual Congress: In December 2023, Cidara presented new preclinical data on its novel Cloudbreak, multi-specific CD73/PD-1 targeting DFC candidate at the ESMO Immuno-Oncology (IO) Annual Congress. The Company also presented new preclinical data on Cloudbreak CBO421, its first-in-class CD73-targeting DFC.
•Presented at SITC’s 38th Annual Meeting: In November 2023, Cidara presented new preclinical data on Cloudbreak CBO421 at the Society for Immunotherapy of Cancer (SITC)’s 38th Annual Meeting.
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•Received EU and UK approval for REZZAYO for the treatment of invasive candidiasis in adults: In December 2023 and January 2024, Cidara and Mundipharma announced REZZAYO had been approved in the EU and UK, respectively, for the treatment of invasive candidiasis in adults. Cidara received a milestone payment of approximately $11.1 million from Mundipharma in February 2024 for the EU approval of rezafungin and received a milestone payment of approximately $2.8 million from Mundipharma in April 2024 for the UK approval of rezafungin, in accordance with the terms of the Collaboration and License Agreement, dated September 3, 2019, by and between the Company and Mundipharma.
•Completed enrollment in the Phase 3 ReSTORE trial of rezafungin in China: In December 2023, Cidara and Mundipharma announced the completion of enrollment in the Phase 3 ReSTORE trial in China evaluating the efficacy and safety of rezafungin as a treatment for candidemia and invasive candidiasis. The portion of the trial conducted in China included 52 patients diagnosed with candidemia and/or invasive candidiasis. ReSTORE (NCT03667690) is a global, randomized, double-blind, controlled Phase 3 pivotal clinical trial evaluating the efficacy and safety of once-weekly intravenous dosing of rezafungin compared to once-daily dosing of caspofungin, the current standard of care, to treat patients with candidemia and/or invasive candidiasis. Data from this study are expected in the second quarter of 2024.
•Named San Diego Metro Area Top Workplace: In November 2023, Cidara was named a Top Workplace by The San Diego Union-Tribune for the sixth year, ranking among the top 100 companies.
Fourth Quarter and Full Year 2023 Financial Results
•Revenue totaled $17.6 million and $63.9 million for the three months and full year ended December 31, 2023, respectively, compared with $10.2 million and $64.4 million for the same periods in 2022.
Revenue for the year ended December 31, 2023 related to the achievement of milestones and ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta of $16.4 million, $23.3 million and $19.7 million, respectively, $0.2 million in royalty revenue recognized following initiation of the commercial launch of REZZAYO in the U.S. on July 31, 2023, as well as product revenue of $4.3 million related to shipments of REZZAYO naked vials to Melinta and Mundipharma.
Revenue for the year ended December 31, 2022 included $25.9 million of revenue recognized upon transfer of an intellectual property license to Melinta in August 2022. The remaining revenue for the year ended December 31, 2022 related to the achievement of milestones and ongoing research and development and clinical supply services provided to Mundipharma, Janssen and Melinta of $14.3 million, $23.5 million and $0.8 million, respectively.
•Cash and cash equivalents totaled $35.8 million as of December 31, 2023, compared with $32.7 million as of December 31, 2022.
•As of December 31, 2023, Cidara had 90,601,999 shares of common stock outstanding, and 2,104,472 shares of Series X Convertible Preferred Stock outstanding, which are convertible into 21,044,720 shares of common stock.
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•Cost of product revenue was $1.5 million for the year ended December 31, 2023 and primarily consisted of direct material costs, third-party manufacturing costs and indirect overhead costs associated with the manufacture, quality assessment and delivery of REZZAYO naked vials shipped to Melinta and Mundipharma. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred.
•Research and development expenses were $14.7 million and $68.5 million for the three months and full year ended December 31, 2023, respectively, compared to $20.1 million and $77.4 million for the same periods in 2022. The decrease in research and development expenses for the full year ended December 31, 2023 compared to the full year ended December 31, 2022 is primarily due to lower clinical expenses associated with the rezafungin clinical trials and lower consulting and personnel costs, offset by higher clinical expenses associated with our Cloudbreak platform.
•Selling, general and administrative (SG&A) expenses were $5.4 million and $18.3 million for the three months and full year ended December 31, 2023, respectively, compared to $3.6 million and $20.5 million for the same periods in 2022. The decrease in SG&A expenses for the full year ended December 31, 2023 compared to the full year ended December 31, 2022 is primarily due to lower consulting, personnel and legal costs, and lower amortization of contract costs related to obtaining the Melinta License Agreement, offset by higher selling expenses related to REZZAYO.
•Net loss for the three months ended December 31, 2023 was $3.2 million, compared to a net loss of $13.6 million for the three months ended December 31, 2022. Net loss for the full year ended December 31, 2023 was $22.9 million, compared to a net loss of $33.6 million for the year ended December 31, 2022.
Restatement of Consolidated Financial Statements
The financial results included herein and the financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the Form 10-K) have been restated to account for indirect taxes that led to understatements of accrued liabilities and operating expenses, as more fully described in our Current Report on Form 8-K filed with the United States (U.S.) Securities and Exchange Commission (the SEC) on April 16, 2024 and in the Form 10-K.
About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA and EC approval for REZZAYO® (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
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Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to whether the advantages of the CD388 program for influenza will continue to translate to our Cloudbreak oncology DFC programs, whether we will file an IND in mid-2024 for CBO421, whether we will achieve future royalties and milestones under both our Melinta and Mundipharma licensing agreements, whether we will receive additional milestones, and any royalties, from our collaboration agreement with Janssen, and the timing of data from the Phase 3 ReSTORE trial of rezafungin. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s preclinical or clinical trials, delays in action by regulatory authorities, and other obstacles on the enrollment of patients or other aspects of rezafungin, CD388, or other DFC development. These and other risks are identified under the caption “Risk Factors” in Cidara’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and other filings subsequently made with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com
MEDIA CONTACT:
Veronica Eames
LifeSci Communications
(646) 970-4682
veames@lifescicomms.com
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CIDARA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations
Three months ended
December 31,
Year ended
December 31,
(In thousands, except share and per share data) 2023 2022 2023 2022
(As Restated) (As Restated)
Revenues: (Unaudited) (Unaudited)
Collaboration revenue $ 14,716  $ 10,219  $ 59,570  $ 64,448 
Product revenue 2,867  —  4,335  — 
Total revenues 17,583  10,219  63,905  64,448 
Operating expenses:
Cost of product revenue 1,136  —  1,523  — 
Research and development 14,718  20,111  68,532  77,405 
Selling, general and administrative 5,405  3,595  18,333  20,546 
Total operating expenses 21,259  23,706  88,388  97,951 
Loss from operations (3,676) (13,487) (24,483) (33,503)
Other income, net:
Interest income, net 527  162  1,995  191 
Total other income, net 527  162  1,995  191 
Loss before income tax expense (3,149) (13,325) (22,488) (33,312)
Income tax expense (64) (272) (443) (272)
Net loss and comprehensive loss $ (3,213) $ (13,597) $ (22,931) $ (33,584)
Basic and diluted net loss per common share $ (0.04) $ (0.19) $ (0.26) $ (0.48)
Shares used to compute basic and diluted net loss per common share 90,504,622  71,895,890  87,427,439  69,857,698 

Condensed Consolidated Balance Sheet Data
December 31,
2023 2022
(In thousands) (As Restated)
Cash and cash equivalents $ 35,778  $ 32,731 
Total assets 67,030  47,487 
Total liabilities 75,240  61,925 
Total stockholders’ deficit
(8,210) (14,438)

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EX-99.2 3 ex992-2024x04x22.htm PRESS RELEASE Document
Exhibit 99.2
cidaralogo.jpg
Cidara Therapeutics Announces Reverse Stock Split
SAN DIEGO, April 22, 2024 — Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that the Company effected a reverse stock split of its issued and outstanding common stock, at a ratio of 1-for-20. The effective time of the reverse stock split will be 5 p.m. ET on April 23, 2024. The Company’s common stock will begin trading on a split-adjusted basis commencing upon market open on April 24, 2024.
As previously disclosed, at a special meeting of stockholders held on April 4, 2024, the Company’s stockholders voted to approve a proposal authorizing the Board of Directors of the Company to amend the Company’s certificate of incorporation to effect a reverse stock split and a corresponding reduction in the authorized shares of the Company’s common stock at a ratio that is equal to half of the reverse split ratio. On April 12, 2024, the Board of Directors approved a 1-for-20 reverse stock split.
As a result of the reverse split, each 20 shares of the Company’s issued and outstanding common stock will be automatically combined and converted into one issued and outstanding share of common stock, par value $0.0001 per share. The Company’s common stock will trade under a new CUSIP number, 171757206, effective April 24, 2024, and remain listed on the Nasdaq Capital Market under the symbol “CDTX”. The reverse stock split reduces the number of shares of common stock issuable upon the conversion of the Company’s outstanding shares of preferred stock and the exercise or vesting of its outstanding stock options, restricted stock units and warrants in proportion to the ratio of the reverse stock split and causes a proportionate increase in the conversion and exercise prices of such preferred stock, stock options and warrants.
No fractional shares of common stock will be issued as a result of the reverse stock split. Stockholders of record who would otherwise be entitled to receive a fractional share will receive a cash payment in lieu thereof. The reverse stock split impacts all holders of the Company’s common stock proportionally and will not impact any stockholder’s percentage ownership of the Company common stock (except to the extent the reverse stock split results in any stockholder owing only a fractional share).
Cidara has chosen its transfer agent, Equiniti Trust Company, LLC (Equiniti), to act as exchange agent for the reverse stock split. Stockholders owning shares via a bank, broker or other nominee will have their positions automatically adjusted to reflect the reverse stock split and will not be required to take further action in connection with the reverse stock split, subject to brokers’ particular processes. For those stockholders holding physical stock certificates, Equiniti will send instructions for exchanging those certificates for shares held in book-entry form representing the post-split number of shares. Equiniti can be reached at (877) 248-6417 or (718) 921-8317.
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About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs). These targeted immunotherapies offer the unique opportunity to create “single molecule cocktails” comprised of targeted small molecules and peptides coupled to a human antibody fragment (Fc). DFCs are designed to save lives and improve the standard of care for patients facing cancers and other serious diseases by inhibiting specific disease targets while simultaneously engaging the immune system. In addition, Cidara received FDA and EC approval for REZZAYO® (rezafungin for injection), which it has licensed to multiple partners to commercialize in the U.S. and ex-U.S. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “will” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) convey uncertainty of future events or outcomes and are intended to identify these forward-looking statements. Forward-looking statements describe future expectations, plans, results, or strategies, among other things, and in this release include, but are not limited to, statements regarding the expected commencement of trading of the Cidara’s post-split common stock. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements. Such risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com
MEDIA CONTACT:
Veronica Eames
LifeSci Communications
(646) 970-4682
veames@lifescicomms.com
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