Investors might want to bet on Cidara Therapeutics (CDTX) , as it has been recently upgraded to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.Since a chan ...

Core Insights - Cidara Therapeutics presented promising efficacy and safety results for CD388, a non-vaccine influenza preventative, during the ISRV conference, highlighting its potential for long-term protection against influenza and H5N1 strains [1][2] Group 1: CD388 Efficacy and Safety - The Phase 2b NAVIGATE study involved over 5,000 healthy adults aged 18-64, randomized to receive either CD388 (150mg, 300mg, or 450mg) or placebo, demonstrating statistically significant protection against influenza illness over 24 weeks [1][3] - CD388 was well tolerated, with the primary endpoint focusing on preventative efficacy against laboratory-confirmed influenza [1][3] Group 2: Preclinical Data on H5N1 - Preclinical studies in ferrets showed that a single subcutaneous dose of CD388 at 3 mg/kg provided 75% protection against lethal H5N1 infection, while a 10 mg/kg dose resulted in 100% survival [3] - CD388-treated ferrets exhibited reduced weight loss and clinical symptoms compared to untreated controls, indicating its potential effectiveness against highly pathogenic strains [3] Group 3: Future Plans and Presentations - Cidara plans to disclose additional safety, pharmacokinetics, and virology data from the Phase 2b NAVIGATE study at upcoming conferences [2] - The company will host a lunch symposium at the conference to discuss CD388's broad influenza protection capabilities [5]

Group 1 - The presentation is part of the Morgan Stanley Healthcare Conference, indicating a focus on the healthcare sector [1] - Ryuk Byun serves as a Managing Director at Morgan Stanley's Investment Banking Division, highlighting the company's leadership in investment banking [1] Group 2 - A brief disclosure was mentioned, suggesting that important information will be provided during the conference [1] - Attendees are encouraged to refer to the Morgan Stanley research disclosure website for important disclosures, emphasizing transparency in communications [2]

Group 1 - The presentation is part of the Morgan Stanley Healthcare Conference, indicating a focus on the healthcare sector [1] - Ryuk Byun serves as a Managing Director at Morgan Stanley's Investment Banking Division, highlighting the company's leadership in investment banking [1] Group 2 - A brief disclosure was mentioned, suggesting that important information will be provided during the session [1] - Attendees are encouraged to reach out to their Morgan Stanley sales representative for any questions, indicating a proactive approach to client engagement [2]

Core Viewpoint - BAE Systems is targeting to launch an autonomous submarine by 2026, driven by increasing global concerns over underwater threats following a series of attacks [1] Group 1: Company Developments - BAE Systems is focusing on the development of autonomous submarine technology to address rising security concerns from various countries [1] - The company aims to capitalize on the growing demand for advanced underwater defense solutions [1] Group 2: Industry Trends - There is a notable increase in interest from nations regarding underwater threats, which is influencing defense strategies and investments [1] - The market for autonomous military technologies, particularly in naval defense, is expected to expand significantly in the coming years [1]

Company Overview - Cidara Therapeutics is a biotechnology company utilizing its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics [2] - The lead DFC candidate, CD388, is designed for universal prevention of seasonal and pandemic influenza with a single dose by inhibiting viral proliferation [2] - Cidara received Fast Track Designation from the FDA for CD388 in June 2023 and announced positive top-line results from its Phase 2b NAVIGATE trial in June 2025 [2] - Additional DFCs are being developed for oncology, with Cidara receiving investigational new drug application clearance for CBO421 in July 2024, targeting CD73 in solid tumors [2] Upcoming Events - Cidara management will participate in the H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025, at 4:00 PM ET in a corporate presentation format [1] - The company will also take part in the Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, at 7:00 AM ET in a fireside chat format [1] - Cidara will engage in one-on-one investor meetings during these conferences [1]

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[