Cidara Therapeutics(CDTX) - 2025 Q2 - Quarterly Results

Corporate Update and Business Highlights This section provides an overview of the company's recent clinical trial successes and significant financial strengthening CD388 Program Update Cidara reported compelling Phase 2b NAVIGATE trial results for CD388, meeting all efficacy endpoints for influenza prevention and prompting an FDA End-of-Phase 2 meeting request - The Phase 2b NAVIGATE trial for CD388 met all primary and secondary efficacy endpoints for preventing seasonal influenza[1][3][4] CD388 Phase 2b NAVIGATE Efficacy Results (vs. Placebo) | Dose | Protection Rate | Placebo Attack Rate | | :--- | :--- | :--- | | 450mg | 76.1% | 2.8% | | 300mg | 61.3% | 2.8% | | 150mg | 57.7% | 2.8% | - CD388 was well-tolerated with no safety signals observed across all dose groups[4] - An End-of-Phase 2 meeting request was submitted to the FDA in June 2025 to discuss the planned Phase 3 study, targeted to begin no later than spring 2026[1][3][4] Corporate and Financial Developments The company significantly strengthened its financial position through a $402.5 million public offering and enhanced its investment community visibility by joining Russell Indexes - Closed an upsized public offering of common stock, raising gross proceeds of $402.5 million to fund the planned Phase 3 program for CD388[3][6] - In June 2025, Cidara was added to the Russell 2000® and Russell 3000® Indexes, increasing its visibility to institutional investors[3][6] Second Quarter 2025 Financial Results This section details Cidara's financial performance for Q2 2025, highlighting improved net loss, increased cash reserves, and operational shifts Financial Position Cidara's cash, cash equivalents, and restricted cash substantially increased to $516.9 million by June 30, 2025, primarily due to a $402.5 million public offering Cash Position (in millions) | Date | Cash, cash equivalents and restricted cash | | :--- | :--- | | June 30, 2025 | $516.9 | | Dec 31, 2024 | $196.2 | Operational Performance Cidara reported a net loss of $25.7 million in Q2 2025, a significant improvement from Q2 2024, driven by the absence of a large acquired IPR&D expense and increased R&D for CD388 Q2 Financial Performance Comparison (in millions) | Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $0.0 | $0.3 | ($0.3) | | R&D Expenses | $24.8 | $6.7 | +$18.1 | | G&A Expenses | $6.5 | $4.7 | +$1.8 | | Acquired IPR&D | $0.0 | $84.9 | ($84.9) | | Net Loss | ($25.7) | ($91.2) | +$65.5 | - The increase in R&D expenses was primarily due to costs associated with the CD388 Phase 2b NAVIGATE study and preparations for the planned Phase 3 study[6] - Collaboration revenue was zero for the quarter, as the agreement with Janssen was terminated on April 24, 2024[6] - The company reversed $3.9 million in accrued indirect tax liabilities related to former rezafungin assets, which reduced operating expenses[6] Discontinued Operations Income from discontinued operations was zero in Q2 2025, following the sale of all rezafungin assets in April 2024, contrasting with $3.0 million in Q2 2024 - On April 24, 2024, all rezafungin assets were sold to Napp, an affiliate of Mundipharma, and are now reported as discontinued operations[10] Income from Discontinued Operations (in millions) | Period | Income | | :--- | :--- | | Q2 2025 | $0.0 | | Q2 2024 | $3.0 | Financial Statements This section presents the unaudited condensed consolidated statements of operations and balance sheet data for Cidara Therapeutics Condensed Consolidated Statements of Operations The unaudited statements show a net loss of $25.7 million for Q2 2025, a significant improvement from $91.2 million in Q2 2024, with basic and diluted net loss per share at $1.65 Statement of Operations Highlights (Three Months Ended June 30, in thousands) | Line Item | 2025 | 2024 | | :--- | :--- | :--- | | Total revenues | $0 | $302 | | Total operating expenses | $27,384 | $96,286 | | Loss from operations | ($27,384) | ($95,984) | | Net loss | ($25,718) | ($91,209) | | Net loss per common share | ($1.65) | ($19.99) | Condensed Consolidated Balance Sheet Data Total assets increased to $534.3 million by June 30, 2025, driven by a substantial rise in cash, while total liabilities decreased and stockholders' equity grew to $501.2 million Balance Sheet Highlights (in thousands) | Line Item | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and restricted cash | $516,913 | $196,177 | | Total assets | $534,327 | $214,796 | | Total liabilities | $33,154 | $51,488 | | Total stockholders' equity | $501,173 | $163,308 | Supplementary Information This section provides background on Cidara Therapeutics, details on the Q2 2025 conference call, and important forward-looking statement disclaimers About Cidara Therapeutics Cidara Therapeutics is a biotechnology company leveraging its Cloudbreak® platform to develop Drug-Fc Conjugates, with lead candidate CD388 for influenza prevention and an oncology pipeline - Cidara's core technology is the Cloudbreak® platform for developing Drug-Fc Conjugates (DFCs)[9] - The lead candidate, CD388, is designed for single-dose, universal prevention of seasonal and pandemic influenza[9] - The company's oncology pipeline includes CBO421, which targets CD73 in solid tumors and received IND clearance in July 2024[9] Conference Call and Webcast Cidara management hosted a conference call and webcast on August 7, 2025, to discuss Q2 results and provide a corporate update, with a replay available online - A conference call and webcast was held on August 7, 2025, at 5:00 pm ET to discuss the Q2 2025 results[7] Forward-Looking Statements This section warns that statements regarding future expectations and clinical trial outcomes are forward-looking and subject to risks detailed in SEC filings - The press release contains forward-looking statements regarding the future of CD388 and its clinical trials, which are not guarantees of future performance[11] - Investors are advised that actual results could differ materially from projections due to various risks and uncertainties, which are detailed in the company's SEC filings under "Risk Factors"[11]