“Our reacquisition of our CD388 program, which we have developed to date in collaboration with
Recent Corporate Highlights
- Reacquired exclusive global development and commercial rights to CD388: In
April 2024 , Cidara entered into a definitive agreement with Janssen, to reacquire the exclusive global development and commercial rights to CD388, which is in development for the prevention of all strains of influenza A and B. Cidara is finalizing the protocol for a Phase 2b clinical trial, which the Company intends to initiate during the upcoming Northern Hemisphere influenza season. - Closed
$240 .0 million private placement: InApril 2024 and in conjunction with the reacquisition of CD388, Cidara closed a definitive agreement for the sale of preferred stock in a$240 .0 million private placement led byRA Capital Management , with significant participation from Bain Capital Life Sciences, BVF, andCanaan Partners . The proceeds from the private placement were used to fund the upfront payment of$85 .0 million under the agreement with Janssen and the remainder of the gross proceeds of$155 .0 million are expected to provide runway beyond topline data from CD388’s planned Phase 2b trial. - Divested rezafungin to its former licensee,
Mundipharma : InApril 2024 , Cidara entered into an asset purchase agreement withNapp Pharmaceutical Group Limited , a member of the international network ofMundipharma independent associated companies, for the divestiture of rezafungin. Cidara estimates that it will achieve approximately$128 .0 million in cost savings over the patent life of rezafungin. - Appointed
Laura Tadvalkar , Ph.D.,Ryan Spencer , andJames Merson , Ph.D., to Board of Directors: InApril 2024 and in connection with the private placement, appointedDr. Tadvalkar , Managing Director atRA Capital Management ,Mr. Spencer , Chief Executive Officer and a director of Dynavax Technologies, andDr. Merson , former Global Therapeutic Area Head for Infectious Diseases atJanssen Research & Development, LLC , to the Company’s Board of Directors, whileDavid Gollaher , Ph.D. andTimothy Franson , M.D., stepped down from the Board. - Announced a Reverse Stock Split: On
April 12, 2024 , Cidara’s Board of Directors approved a 1-for-20 reverse stock split. OnApril 22, 2024 the Company filed an amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of its issued and outstanding common stock, at a ratio of 1-for-20, and 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. The Company’s common stock began trading on a split-adjusted basis commencing upon market open onApril 24, 2024 under a new CUSIP number, 171757206, and remain listed on the Nasdaq Capital Market under the symbol “CDTX”. - Presented at 34th
European Society of Clinical Microbiology and Infectious Diseases (ESCMID) conference: InApril 2024 , Cidara presented data from the Phase 2a study of CD388, showing the DFC was well tolerated and demonstrated statistically significant antiviral effects when administered as a single subcutaneous dose in healthy volunteers challenged with influenza at the 34th ESCMID conference. The Company also presented data from a Phase 1 single ascending dose study of CD388 which showed the drug has an extended half-life of 6-8 weeks. - Presented at AACR Annual Meeting 2024: In
April 2024 , Cidara presented 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.
First Quarter 2024 Financial Results
- Revenue totaled
$8.5 million for the three months endedMarch 31, 2024 , compared to$26.1 million for the same period in 2023. Revenue for the three months endedMarch 31, 2024 related to the achievement of a milestone, ongoing research and development and clinical supply services provided toMundipharma , Janssen and Melinta, royalty revenue, as well as product revenue related to shipments of REZZAYO naked vials toMundipharma . Revenue for the three months endedMarch 31, 2023 related to the achievement of a milestone and ongoing research and development and clinical supply services provided toMundipharma , Janssen and Melinta. - Cash and cash equivalents totaled
$29.0 million as ofMarch 31, 2024 , compared with$35.8 million as ofDecember 31, 2023 . - Cost of product revenue was
$1.6 million for the three months endedMarch 31, 2024 , 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 toMundipharma . 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
$11.6 million for the three months endedMarch 31, 2024 , compared to$18.9 million for the same period in 2023. The decrease in research and development expenses for the three months endedMarch 31, 2024 , compared to the three months endedMarch 31, 2023 is primarily due to lower clinical expenses associated with the rezafungin clinical trials, lower clinical expenses associated with our Cloudbreak platform and lower personnel costs. - Selling, general and administrative (SG&A) expenses were
$6.0 million for the three months endedMarch 31, 2024 , compared to$4.5 million for the same period in 2023. The SG&A expenses for all periods primarily relate to consulting, personnel and legal costs. - Net loss for the three months ended
March 31, 2024 was$10.3 million , compared to a net income of$3.0 million for the same period in 2023. - During the three months ended
March 31, 2024 , Cidara did not sell shares of common stock pursuant to its at-the-market sales agreement. - As of
March 31, 2024 , Cidara had 4,561,696 shares of common stock outstanding and 2,104,472 shares of Series X Convertible Preferred Stock outstanding, which are convertible into 1,052,236 shares of common stock.
About
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 we will start a Phase 2b clinical trial for CD388 in 2024, whether CD388 will be shown to have advantages beyond and in addition to flu vaccines, and whether CD388 will ultimately be approved for commercial sale by regulators in the
INVESTOR CONTACT:
(212) 915-2578
britchie@lifesciadvisors.com
MEDIA CONTACT:
mfitzhugh@lifescicomms.com
Condensed Consolidated Statements of Operations (unaudited) | |||||||
Three Months Ended | |||||||
(In thousands, except share and per share data) | 2024 | 2023 | |||||
Revenues: | |||||||
Collaboration revenue | $ | 5,637 | $ | 26,107 | |||
Product revenue | 2,826 | — | |||||
Total revenues | 8,463 | 26,107 | |||||
Operating expenses: | |||||||
Cost of product revenue | 1,563 | — | |||||
Research and development | 11,593 | 18,869 | |||||
Selling, general and administrative | 5,998 | 4,457 | |||||
Total operating expenses | 19,154 | 23,326 | |||||
Income (loss) from operations | (10,691 | ) | 2,781 | ||||
Other income, net: | |||||||
Interest income, net | 365 | 232 | |||||
Total other income, net | 365 | 232 | |||||
Net income (loss) and comprehensive income (loss) | (10,326 | ) | 3,013 | ||||
Allocation of earnings to participating securities | — | (636 | ) | ||||
Net income (loss) attributable to common stockholders | $ | (10,326 | ) | $ | 2,377 | ||
Basic net earnings (loss) per common share | $ | (2.28 | ) | $ | 0.60 | ||
Diluted net earnings (loss) per common share | $ | (2.28 | ) | $ | 0.60 | ||
Shares used to compute basic net earnings (loss) per common share | 4,537,782 | 3,932,050 | |||||
Shares used to compute diluted net earnings (loss) per common share | 4,537,782 | 5,059,514 |
Condensed Consolidated Balance Sheet Data | |||||||
2024 | 2023 | ||||||
(In thousands) | (unaudited) | ||||||
Cash and cash equivalents | $ | 29,018 | $ | 35,778 | |||
Total assets | 52,716 | 67,030 | |||||
Total liabilities | 70,496 | 75,240 | |||||
Total stockholders’ equity (deficit) | (17,780 | ) | (8,210 | ) |
Source:
2024 GlobeNewswire, Inc., source