On August 13, 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, reported financial results for the second quarter ended June 30, 2024, and provided an update on its corporate activities and product pipeline (Press release, Cidara Therapeutics, AUG 13, 2024, View Source [SID1234645802]).
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"We continue to focus on our Cloudbreak DFC platform with the advancement of CD388 and other programs," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Our Phase 2b study to evaluate the efficacy and safety of CD388, a long-acting drug candidate that provides season-long, universal protection from influenza, is on track to start in the fall of 2024 during the Northern Hemisphere influenza season with 4,000 subjects to be enrolled in the United States and 1,000 subjects to be enrolled in the United Kingdom. We believe that CD388 has important advantages over vaccines to provide long-term protection against both seasonal and pandemic strains of influenza with a single dose per flu season."
Recent Corporate Highlights
Reacquired exclusive global development and commercial rights to CD388: In April 2024, Cidara entered into a definitive agreement with J&J Innovative Medicine, previously Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (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 (Janssen License Agreement). Cidara is finalizing the protocol for a Phase 2b clinical trial, which the Company intends to initiate in the fall of 2024 during the Northern Hemisphere influenza season.
Closed $240.0 million private placement: In April 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 (Private Placement) led by RA Capital Management, with significant participation from Bain Capital Life Sciences, Biotech Value Fund and Canaan 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: In April 2024, Cidara entered into an asset purchase agreement with Napp Pharmaceutical Group Limited (Napp), a member of the international network of Mundipharma independent associated companies (Mundipharma), for the divestiture of rezafungin (Purchase Agreement). Cidara estimates that it will achieve approximately $128.0 million in cost savings over the patent life of rezafungin. On July 18, 2024, Cidara received a notice of satisfaction from Mundipharma that it had completed the required performance obligations under a transition services agreement and, accordingly, the $11.1 million development milestone advance previously made to Cidara, and reimbursable to Mundipharma, was forgiven by Mundipharma.
IND Clearance for CBO421: Cidara received investigational new drug application (IND) clearance for CBO421 in July 2024.
Second Quarter 2024 Financial Results
Revenue totaled $0.3 million and $1.3 million for the three and six months ended June 30, 2024, respectively, compared to $5.1 million and $11.3 million for the same periods in 2023, respectively. Revenue for the three and six months ended June 30, 2024 and 2023 related to research and development and clinical supply services provided to Janssen under the preexisting Janssen Collaboration Agreement. The Janssen Collaboration Agreement was terminated upon the effectiveness of the Janssen License Agreement on April 24, 2024.
Cash and cash equivalents totaled $164.4 million as of June 30, 2024, compared with $35.8 million as of December 31, 2023.
Acquired in-process research and development expenses were $84.9 million for the three and six months ended June 30, 2024 and related to an upfront payment of $85.0 million paid to Janssen under the Janssen License Agreement, on April 24, 2024, plus $0.4 million in direct transaction costs, offset by a settlement gain of $0.5 million to settle the preexisting Janssen Collaboration Agreement relationship.
Research and development expenses were $6.7 million and $12.6 million for the three and six months ended June 30, 2024, respectively, compared to $8.7 million and $18.4 million for the same periods in 2023, respectively. The decrease in research and development expenses for the three and six months ended June 30, 2024, compared to the three and six months ended June 30, 2023 is primarily due to lower nonclinical expenses associated with our Cloudbreak platform, offset by higher personnel costs supporting our Cloudbreak platform.
Selling, general and administrative (SG&A) expenses were $4.7 million and $8.3 million for the three and six months ended June 30, 2024, respectively, compared to $3.2 million and $6.8 million for the same period in 2023, respectively. The SG&A expenses for all periods primarily relate to consulting, personnel and legal costs.
On April 24, 2024, Cidara entered into the Purchase Agreement with Napp, pursuant to which we sold to Napp all of its rezafungin assets and related contracts. We completed all conditions of the sale on April 24, 2024. We determined that the sale of rezafungin represented a strategic shift that will have a major effect on our operations and financial results. Accordingly, the sale of rezafungin is classified as discontinued operations. Net income from discontinued operations for the three months ended June 30, 2024, was $3.0 million and net income from discontinued operations for the six months ended June 30, 2024 was $0.9 million, compared to net loss from discontinued operations of $7.5 million and net income from discontinued operations of $2.5 million for the same periods in 2023, respectively.
Net loss for the three and six months ended June 30, 2024 was $91.2 million and $101.5 million, respectively, compared to a net loss of $13.6 million and $10.6 million for the same periods in 2023, respectively.
During the three and six months ended June 30, 2024, Cidara did not sell shares of common stock pursuant to its at-the-market sales agreement.
As of June 30, 2024, Cidara had 4,568,991 shares of common stock outstanding, 240,000 shares of Series A Convertible Voting Preferred Stock outstanding, which are convertible into 16,800,000 shares of common stock, and 2,104,472 shares of Series X Convertible Preferred Stock outstanding, which are convertible into 1,052,236 shares of common stock.
On July 18, 2024, the Company’s stockholders approved the issuance of up to 16,800,000 shares of common stock upon conversion of 240,000 shares of Series A Convertible Voting Preferred Stock issued in the Private Placement completed in April 2024. On July 19, 2024, the Company issued 2,469,250 shares of common stock upon automatic conversion of 35,275 shares of Series A Convertible Voting Preferred Stock. Cidara had 7,038,241 shares of common stock issued and outstanding immediately following this automatic conversion.