Core Insights - Cidara Therapeutics will present two oral presentations, including a late-breaking abstract, at the ISRV 8th AntiViral Group Meeting and 3rd International Meeting on Respiratory Pathogens in Singapore from September 17-20, 2025 [1][2] Group 1: Presentation Details - The late-breaking abstract titled "NAVIGATE: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Dose-ranging Trial to Evaluate the Efficacy and Safety of CD388 for Prevention of Influenza Illness in Healthy Adults" will be presented by Dr. Rick Bright on September 17, 2025, from 3:50 – 4:05 p.m. SGT [2] - Another abstract titled "A Single Prophylactic dose of CD388 Provides Protection Against Highly Pathogenic Bovine-Origin Influenza A (H5N1) Virus in the Ferret Model" will be presented by Dr. Andreev Konstantin on September 19, 2025, from 10:30 a.m. – 12:30 p.m. SGT [2] Group 2: Company Overview - Cidara Therapeutics utilizes its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, with its lead candidate CD388 designed for universal prevention of seasonal and pandemic influenza with a single dose [3] - CD388 received Fast Track Designation from the FDA in June 2023 and positive top-line results from its Phase 2b NAVIGATE trial were announced in June 2025 [3]

Core Insights - The article discusses the investment potential of CDTX, highlighting a beneficial long position in its shares [1]. Group 1 - The analyst expresses a personal opinion on CDTX, indicating a positive outlook based on their own analysis [1]. - There is no compensation received for the article, emphasizing the independence of the analysis [1]. - The article does not provide specific investment recommendations, focusing instead on the author's views [2].

Financial Data and Key Metrics Changes - The company reported a substantial financing of $400 million to support its operations and clinical development [5][13] - The observed placebo attack rate in the NAVIGATE study was 2.8%, allowing for statistically significant efficacy results for CD388 [9] Business Line Data and Key Metrics Changes - CD388 demonstrated protection rates of 76%, 61%, and 58% at doses of 450 mg, 300 mg, and 150 mg respectively, significantly exceeding the historical average vaccine effectiveness of approximately 40% [9][10] - The safety and tolerability data for CD388 were consistent with prior studies, showing no safety signals across all dose groups [10] Market Data and Key Metrics Changes - The company plans to focus on high-risk populations, including immunocompromised patients, who are disproportionately affected by influenza [12] - The company is preparing to advance CD388 into Phase 3 trials, with plans to initiate in the Southern Hemisphere in 2026, pending FDA feedback [11][12] Company Strategy and Development Direction - The company aims to address high unmet needs in influenza prevention with CD388, which has received fast track and priority review designations from the FDA [12][13] - The company is also pursuing a breakthrough therapy designation for CD388, expecting to hear the outcome later this year [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of CD388 to provide robust seasonal protection against influenza, particularly for immune-compromised individuals [14] - The company is operationally prepared to start the Phase 3 study this fall, depending on the outcome of the end of Phase 2 meeting with the FDA [12] Other Important Information - The company has submitted proposals to BARDA for funding to support manufacturing and clinical development of CD388, with expectations to learn the outcome by the end of the year [13] - The company plans to present additional details from the NAVIGATE trial at scientific conferences later this year [10][14] Q&A Session Summary Question: Differences from the Type C meeting with FDA and Phase III design - Management does not anticipate substantial differences from the Type C meeting, as alignment was largely reached prior to the NAVIGATE Phase 2B results [19][20] Question: BARDA grant expectations - The base period of the BARDA grant would fund manufacturing, particularly onshoring to the US, with options for additional clinical studies in the option period [20] Question: Update on FDA meeting outcomes - The company will await the FDA meeting minutes to communicate the results and any potential changes to the study design [28][30] Question: Cash runway assumptions - The company believes it is adequately funded through the end of the Phase III program, including additional studies [45] Question: Commercial outlook in light of Sanofi's decline - Management noted downward pressure on vaccine businesses but emphasized the unique value proposition of CD388 in addressing high-risk populations [47] Question: Upcoming scientific presentations - The company has submitted abstracts to ISIRV and IDWeek, with expectations for acceptance and presentations on Phase 2B data [51][52]

[FORM 10-Q Cover Page](index=1&type=section&id=FORM%2010-Q%20Cover%20Page) Cidara Therapeutics, Inc. filed its Form 10-Q for Q2 2025, classified as a non-accelerated and smaller reporting company - CIDARA THERAPEUTICS, INC. filed its Quarterly Report on Form 10-Q for the period ended June 30, 2025[2](index=2&type=chunk) - The registrant is classified as a **Non-accelerated filer** and a **Smaller reporting company**[3](index=3&type=chunk) - As of August 6, 2025, the registrant had **25,358,051 shares of Common Stock** ($0.0001 par value) outstanding[3](index=3&type=chunk) Trading Information | 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 | [TABLE OF CONTENTS](index=2&type=section&id=TABLE%20OF%20CONTENTS) This section presents the complete organizational structure and content overview of the quarterly report [PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This part presents the unaudited condensed consolidated financial statements and management's discussion and analysis [ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)](index=3&type=section&id=ITEM%201.%20CONDENSED%20CONSOLIDATED%20FINANCIAL%20STATEMENTS%20(UNAUDITED)) This section presents Cidara Therapeutics' unaudited condensed consolidated financial statements and related notes for Q2 2025 [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section presents the company's financial position, detailing assets, liabilities, and equity at June 30, 2025 Condensed Consolidated Balance Sheets (in thousands) | (In thousands) | June 30, 2025 | December 31, 2024 | | :------------- | :------------ | :---------------- | | **ASSETS** | | | | Cash and cash equivalents | $510,575 | $189,825 | | Total current assets | $531,791 | $210,737 | | Total assets | $534,327 | $214,796 | | **LIABILITIES AND STOCKHOLDERS' EQUITY** | | | | Total current liabilities | $32,318 | $49,554 | | Total liabilities | $33,154 | $51,488 | | Total stockholders' equity | $501,173 | $163,308 | | Total liabilities and stockholders' equity | $534,327 | $214,796 | - Cash and cash equivalents significantly increased from **$189.8 million** at December 31, 2024, to **$510.6 million** at June 30, 2025[8](index=8&type=chunk) - Total stockholders' equity increased substantially from **$163.3 million** to **$501.2 million**, primarily due to financing activities[8](index=8&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's revenues, expenses, and net loss for Q2 2025 and 2024 Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | (In thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total revenues | $0 | $302 | $0 | $1,275 | | Total operating expenses | $27,384 | $96,286 | $52,653 | $105,801 | | Loss from operations | $(27,384) | $(95,984) | $(52,653) | $(104,526) | | Net loss and comprehensive loss | $(25,718) | $(91,209) | $(49,198) | $(101,535) | | Basic and diluted net loss per common share | $(1.65) | $(19.99) | $(3.31) | $(22.31) | - Collaboration revenue ceased in 2025 due to the termination of the Janssen Collaboration Agreement and the sale of Rezafungin assets[9](index=9&type=chunk) - Net loss significantly decreased in 2025 compared to 2024, primarily due to the absence of acquired in-process R&D expenses and a reversal of indirect tax liabilities[9](index=9&type=chunk) - Research and development expenses increased substantially in 2025, reflecting the company's focus on the CD388 program[9](index=9&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents cash flows from operating, investing, and financing activities for Q2 2025 and 2024 Condensed Consolidated Statements of Cash Flows (in thousands) | (In thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(62,911) | $(110,424) | | Net cash provided by (used in) investing activities | $185 | $(23) | | Net cash provided by financing activities | $383,462 | $239,038 | | Net increase in cash, cash equivalents and restricted cash | $320,736 | $128,591 | | Cash, cash equivalents and restricted cash at end of period | $516,913 | $164,369 | - Net cash used in operating activities decreased from **$110.4 million** in 2024 to **$62.9 million** in 2025[12](index=12&type=chunk) - Financing activities provided significant cash inflows in both periods, with **$383.5 million** in 2025 primarily from public offerings, and **$239.0 million** in 2024 from a private placement[12](index=12&type=chunk) [Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Convertible%20Preferred%20Stock%20and%20Stockholders'%20Equity%20(Deficit)) This section details changes in convertible preferred stock and stockholders' equity for Q2 2025 Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders' Equity (Deficit) (in thousands, except share data) | (In thousands, except share data) | Balance at Dec 31, 2024 | Balance at June 30, 2025 | | :-------------------------------- | :---------------------- | :----------------------- | | Common Stock Shares | 10,946,635 | 23,234,839 | | Common Stock Amount | $1 | $2 | | Additional Paid-In Capital | $774,565 | $1,161,627 | | Accumulated Deficit | $(611,258) | $(660,456) | | Total Stockholders' Equity | $163,308 | $501,173 | - Total stockholders' equity increased significantly from **$163.3 million** at December 31, 2024, to **$501.2 million** at June 30, 2025, driven by public offerings and at-the-market offerings[14](index=14&type=chunk) - Common stock shares outstanding more than doubled, from **10,946,635** to **23,234,839**, primarily due to the 2025 Underwritten Public Offering[14](index=14&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations of accounting policies, agreements, and financial statement items [1. THE COMPANY AND BASIS OF PRESENTATION](index=8&type=section&id=1.%20THE%20COMPANY%20AND%20BASIS%20OF%20PRESENTATION) This note describes Cidara Therapeutics' business, Cloudbreak platform, CD388 development, and Rezafungin's discontinued operations - Cidara Therapeutics is a biotechnology company utilizing its Cloudbreak platform to develop DFC therapeutics for serious diseases[18](index=18&type=chunk) - The company reacquired all rights for its lead product candidate, CD388 (for influenza), from Janssen on April 23, 2024[18](index=18&type=chunk) - Positive topline results were announced in June 2025 for the Phase 2b NAVIGATE study of CD388, showing **76.1%**, **61.3%**, and **57.7% protection** from symptomatic influenza for 450mg, 300mg, and 150mg doses, respectively, over 24 weeks compared to placebo[19](index=19&type=chunk) - The company sold all Rezafungin assets on April 24, 2024, classifying it as discontinued operations due to a strategic shift[21](index=21&type=chunk)[22](index=22&type=chunk) - A **1-for-20 reverse stock split** was effected on April 23, 2024[

[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]