[Corporate Update and Business Highlights](index=1&type=section&id=Corporate%20Update%20and%20Business%20Highlights) This section provides an overview of the company's recent clinical trial successes and significant financial strengthening [CD388 Program Update](index=1&type=section&id=CD388%20Program%20Update) 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](index=1&type=chunk)[3](index=3&type=chunk)[4](index=4&type=chunk) 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](index=4&type=chunk) - 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](index=1&type=chunk)[3](index=3&type=chunk)[4](index=4&type=chunk) [Corporate and Financial Developments](index=1&type=section&id=Corporate%20and%20Financial%20Developments) 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](index=3&type=chunk)[6](index=6&type=chunk) - In June 2025, Cidara was added to the Russell 2000® and Russell 3000® Indexes, increasing its visibility to institutional investors[3](index=3&type=chunk)[6](index=6&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) This section details Cidara's financial performance for Q2 2025, highlighting improved net loss, increased cash reserves, and operational shifts [Financial Position](index=2&type=section&id=Financial%20Position) 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](index=2&type=section&id=Operational%20Performance) 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](index=6&type=chunk) - Collaboration revenue was zero for the quarter, as the agreement with Janssen was terminated on April 24, 2024[6](index=6&type=chunk) - The company reversed **$3.9 million** in accrued indirect tax liabilities related to former rezafungin assets, which reduced operating expenses[6](index=6&type=chunk) [Discontinued Operations](index=3&type=section&id=Discontinued%20Operations) 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](index=10&type=chunk) Income from Discontinued Operations (in millions) | Period | Income | | :--- | :--- | | Q2 2025 | $0.0 | | Q2 2024 | $3.0 | [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents the unaudited condensed consolidated statements of operations and balance sheet data for Cidara Therapeutics [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheet%20Data) 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](index=3&type=section&id=Supplementary%20Information) This section provides background on Cidara Therapeutics, details on the Q2 2025 conference call, and important forward-looking statement disclaimers [About Cidara Therapeutics](index=3&type=section&id=About%20Cidara%20Therapeutics) 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](index=9&type=chunk) - The lead candidate, CD388, is designed for single-dose, universal prevention of seasonal and pandemic influenza[9](index=9&type=chunk) - The company's oncology pipeline includes CBO421, which targets CD73 in solid tumors and received IND clearance in July 2024[9](index=9&type=chunk) [Conference Call and Webcast](index=3&type=section&id=Conference%20Call%20and%20Webcast) 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](index=7&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) 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](index=11&type=chunk) - 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](index=11&type=chunk)

Core Insights - Cidara Therapeutics, Inc. will report its Q2 2025 financial results and operational highlights on August 7, 2025, followed by a conference call at 5:00 PM Eastern Time [1][2] Company Overview - Cidara Therapeutics is focused on developing drug-Fc conjugates (DFCs) using its proprietary Cloudbreak platform, with its lead candidate CD388 aimed at universal prevention of influenza [3] - CD388 received Fast Track Designation from the FDA in June 2023 and positive top-line results from its Phase 2b NAVIGATE clinical trial were announced in June 2025 [3] - The company has also developed additional DFCs for oncology, including CBO421, which received IND clearance in July 2024 to target CD73 in solid tumors [3]

Core Points - Cidara Therapeutics, Inc. granted non-qualified stock option awards and restricted stock units (RSUs) totaling 12,100 shares to two new employees under the 2020 Inducement Incentive Plan, with a grant date of June 30, 2025 [1][2] - The stock option has an exercise price of $48.71 per share, equal to the closing price on the grant date, and will vest over four years [1] - The Inducement Plan is specifically for granting equity awards to individuals who were not previously employees or who have had a bona fide period of non-employment [2] Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak platform to develop drug-Fc conjugates (DFCs), including the lead candidate CD388, aimed at universal prevention of seasonal and pandemic influenza [3] - CD388 received Fast Track Designation from the FDA in June 2023, and the Phase 2b NAVIGATE trial enrollment was completed in December 2024 [3] - The company has also developed additional DFCs for oncology, including CBO421, which received investigational new drug application clearance in July 2024 [3]

Core Insights - The biopharmaceutical industry is characterized by volatile stock movements, with companies often experiencing rapid rallies and sell-offs due to trial data and product developments [1][2] Company Summaries Nektar Therapeutics (NKTR) - Nektar Therapeutics has seen a significant increase in share price following successful Phase 2b trial results for its immunotherapy drug candidate, Rezpeg, which targets conditions like eczema affecting approximately 10 million patients in the U.S. [4][6] - The stock price surged over 300% within five trading days, reaching just under $30 per share, although it remains significantly lower than its all-time high of over $1,500 from early 2018 [5][6] - Analysts are optimistic, with six out of seven rating the stock as a Buy and a consensus price target of $84.17, indicating a potential upside of about 227% [6] Cidara Therapeutics (CDTX) - Cidara Therapeutics experienced a nearly 150% increase in share price following positive Phase 2b trial results for CD388, a non-vaccine treatment for seasonal influenza, which demonstrated a 76% protection rate for 24 weeks [8][9] - The stock reached its highest level since spring 2021, and analysts are bullish, with all nine ratings being Buy, although the company issued $250 million in new stock, which could dilute existing shares [10] GeneDx Holdings Corp. (WGS) - GeneDx has seen a recent stock surge of nearly 40% after announcing a partnership with Galatea Bio for genetic testing and updated guidance from the American Academy of Pediatrics recommending genomic sequencing for children with developmental delays [12][14] - Despite topping analyst predictions for first-quarter sales and raising revenue guidance for FY 2025, the stock had previously plummeted by almost 50% [12][13] - Six out of eight analysts rate WGS as a Buy, but concerns remain regarding its high valuation and competition in the genomic diagnostics space [15]

Company Overview - Cidara Therapeutics, Inc. is a biotechnology company utilizing its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics [1][4] - The lead DFC candidate, CD388, is designed for universal prevention of seasonal and pandemic influenza with a single dose [4] - Cidara is headquartered in San Diego, California [4] Recent Developments - Cidara has been added to the Russell 2000® and Russell 3000® Indexes, marking an important milestone for the company [1][3] - The inclusion in these indexes enhances visibility with institutional investors following a successful $400 million financing and positive data from the Phase 2b NAVIGATE trial [3] Clinical Trials and Regulatory Status - CD388 received Fast Track Designation from the U.S. FDA in June 2023 [4] - Enrollment for the Phase 2b NAVIGATE trial was completed in December 2024 [4] - Cidara has developed additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors and received investigational new drug application clearance in July 2024 [4]

Group 1 - Cidara Therapeutics, Inc. closed its underwritten public offering of 9,147,727 shares at a price of $44.00 per share, raising gross proceeds of $402.5 million [1] - The offering included the full exercise of the underwriters' option to purchase an additional 1,193,181 shares [1] - The offering was conducted under a shelf registration statement filed with the SEC on May 8, 2025, and declared effective on May 15, 2025 [3] Group 2 - Cidara is utilizing its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with its lead candidate CD388 aimed at universal prevention of influenza [5] - CD388 received Fast Track Designation from the FDA in June 2023, and the Phase 2b NAVIGATE trial enrollment was completed in December 2024 [5] - Cidara has also developed additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors and received investigational new drug application clearance in July 2024 [5]

Core Insights - Cidara Therapeutics, Inc. has made significant progress with its long-lasting flu prophylactic candidate, CD388, as indicated by positive Phase 2b trial results [1] Company Summary - Cidara Therapeutics is a biotechnology company based in San Diego, focusing on innovative treatments [1] - The company has received a "Buy" rating since February 2025, reflecting confidence in its product pipeline [1] Industry Context - The advancements in flu prophylactics, particularly with CD388, highlight the ongoing innovation within the biotech sector, especially in preventive treatments [1]

Core Viewpoint - Cidara Therapeutics, Inc. has announced a public offering of 7,954,546 shares of its common stock priced at $44.00 per share, aiming to raise approximately $350 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering is expected to close on June 26, 2025, subject to customary closing conditions [2]. - Cidara has granted underwriters a 30-day option to purchase an additional 1,193,181 shares at the public offering price [2]. - J.P. Morgan, Morgan Stanley, Guggenheim Securities, and Cantor are acting as joint book-running managers for the offering [3]. Group 2: Regulatory Information - The offering is made pursuant to a shelf registration statement filed with the SEC on May 8, 2025, and declared effective on May 15, 2025 [4]. Group 3: Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with its lead candidate CD388 aimed at universal prevention of influenza [6]. - CD388 received Fast Track Designation from the FDA in June 2023, and the company completed enrollment for its Phase 2b NAVIGATE trial in December 2024 [6]. - Cidara is also developing additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors [6].

Core Viewpoint - Cidara Therapeutics, Inc. plans to initiate an underwritten public offering to sell $250 million of its common stock, with a potential additional 15% option for underwriters [1][2] Group 1: Offering Details - The public offering is subject to market conditions and other factors, with no assurance on completion or terms [1] - The offering is made under a shelf registration statement filed with the SEC on May 8, 2025, and declared effective on May 15, 2025 [3] - Joint book-running managers for the offering include J.P. Morgan, Morgan Stanley, Guggenheim Securities, and Cantor Fitzgerald [2] Group 2: Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with a focus on antiviral and oncology applications [5] - The lead DFC candidate, CD388, aims for universal prevention of seasonal and pandemic influenza and received Fast Track Designation from the FDA in June 2023 [5] - Cidara completed enrollment for its Phase 2b NAVIGATE trial in December 2024 and received investigational new drug application clearance for CBO421 targeting solid tumors in July 2024 [5]

Core Insights - Cidara Therapeutics, Inc. (CDTX) stock surged over 90% following the release of positive topline results from its Phase 2b NAVIGATE trial for CD388, aimed at preventing seasonal influenza in healthy unvaccinated adults aged 18 to 64 [1][6] Study Results - The NAVIGATE trial met its primary endpoint, showing statistically significant prevention efficacy (PE) across all three dose groups, with evaluations conducted over 24 weeks [2] - The highest dose group (450 mg) achieved a 76.1% prevention efficacy, while the 300 mg and 150 mg doses demonstrated 61.3% and 57.7% efficacy, respectively, all statistically significant compared to placebo [3] - Secondary endpoints were also met, including efficacy at specific temperature thresholds and maintenance of PE for up to 28 weeks [2] Safety and Tolerability - CD388 was well-tolerated across all doses, with no unexpected dose-limiting treatment-emergent adverse events reported [3][4] - No serious drug-related adverse events were observed, and injection site reaction rates were consistent across all dose groups [4] Regulatory Actions - Cidara has submitted a request to the FDA for an end of Phase 2 meeting to discuss the results and the design of the upcoming Phase 3 trial [5]