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]

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 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 reported financial results for Q1 2025, highlighting ongoing developments in its CD388 program and the Phase 2b NAVIGATE clinical trial [1][6][11] Recent and Expected Corporate Highlights - The data cutoff for the Phase 2b NAVIGATE trial was established on April 30, 2025, with top-line results expected in late June 2025 [2][4][5] - CD388 is positioned as a differentiated therapeutic option for influenza prevention, with discussions ongoing with the U.S. FDA regarding the statistical analysis plan [2][5] - Preclinical data published in Nature Microbiology indicates CD388's potential as a universal antiviral for influenza prevention [4][5] - Two posters on CD388 were presented at the 38th International Conference on Antiviral Research in March 2025, showcasing study design and preliminary safety data [5] - Recent promotions within the company include Nicole Davarpanah as Chief Medical Officer and Corrina Pavetto as Senior Vice President, Clinical Development [5] Financial Results - Cash, cash equivalents, and restricted cash totaled $174.5 million as of March 31, 2025, down from $196.2 million at the end of 2024 [11][16] - Collaboration revenue was zero for Q1 2025, compared to $1.0 million in Q1 2024, following the termination of the Janssen Collaboration Agreement [11] - R&D expenses increased to $24.6 million in Q1 2025 from $5.9 million in Q1 2024, primarily due to the ongoing Phase 2b NAVIGATE study [11][14] - General and administrative expenses rose to $6.2 million in Q1 2025 from $3.6 million in Q1 2024, driven by higher personnel costs [11][14] - The net loss for Q1 2025 was $23.5 million, compared to a net loss of $10.3 million in Q1 2024 [11][14]

Summary of Sadara Therapeutics Conference Call Company Overview - Sadara Therapeutics was founded in early 2014, focusing on bispecific immunotherapy for infectious diseases [3] - The company advanced an antifungal drug to approval before pivoting to the development of CD388, a drug targeting influenza [4] Core Product and Development - CD388 is a small molecule inhibitor of viral neuraminidase, crucial for the flu virus's exit from infected cells [4] - Sadara reacquired global rights to CD388 through a $240 million financing, enabling the initiation of a 5,000-subject Phase 2b study [7] - The Phase 2b study commenced in September 2022 and completed enrollment in December 2022, coinciding with a severe flu season [7][33] Clinical Data and Efficacy - The Phase 2a study showed a 57% placebo-adjusted response rate, with expectations for the Phase 2b study to meet or exceed this figure [26] - CD388 is not a vaccine; it has a half-life of 6-8 weeks and is dosed once per flu season [13] - The drug's mechanism does not rely on the immune system, making it effective in both immunocompromised and healthy populations [27][36] Target Population - The target population for CD388 includes high-risk, immunocompromised individuals, who have a mortality rate from influenza comparable to that of breast cancer [31] Future Plans and Research - Sadara plans to advance its oncology pipeline, including a CD73 inhibitor for triple-negative breast cancer [47] - The company is also considering opportunities in other infectious diseases, such as RSV [47] Financial Position - As of the end of the previous year, Sadara reported $196 million in cash, sufficient to last until the second half of 2027 without starting a Phase 3 study [50] - The company is in discussions for potential partnerships, especially if Phase 2b results are positive [51] Market Capitalization - The current market cap is reported at $250 million based on common shares, but the fully diluted market cap is approximately $700 million due to preferred shares [52][53] Upcoming Events - Sadara will hold an R&D day on May 22, where they will discuss the flu season's severity and the statistical analysis plan for the Phase 2b data [42][46]

Core Insights - Cidara Therapeutics has announced the promotion of Nicole Davarpanah to Chief Medical Officer and Corrina Pavetto to Senior Vice President of Clinical Development, effective May 1, 2025, during a critical phase of their influenza antiviral candidate CD388's development [1][2] Company Developments - The promotions are significant as Cidara advances its influenza antiviral candidate CD388 through the Phase 2b NAVIGATE trial and prepares for Phase 3 [2] - Dr. Davarpanah has over a decade of clinical development experience, previously holding leadership roles at Genentech/Roche, where she was responsible for early-stage molecules' advancement through clinical development and FDA approval [2][3] - Ms. Pavetto brings over 25 years of experience in clinical research and regulatory affairs, with a focus on infectious diseases, and has previously supported influenza antiviral and vaccine development at BARDA [4] Product Pipeline - Cidara's lead drug-Fc conjugate candidate, CD388, is designed for universal prevention of seasonal and pandemic influenza with a single dose by inhibiting viral proliferation [5] - CD388 received Fast Track Designation from the FDA in June 2023, and the company completed enrollment of its 5,000 patient Phase 2b NAVIGATE trial in December 2024 [5]

Core Insights - Cidara Therapeutics will participate in The Citizens Life Sciences Conference on May 7, 2025, at 11:00 AM ET, with a presentation format and a webcast available [1] - The company will also engage in one-on-one investor meetings during the event [2] Company Overview - Cidara Therapeutics is focused on developing drug-Fc conjugates (DFCs) using its proprietary Cloudbreak platform, which combines targeted small molecules or peptides with a human antibody fragment [3] - The lead DFC candidate, CD388, is designed for universal prevention of seasonal and pandemic influenza with a single dose and has received Fast Track Designation from the FDA [3] - CD388 completed Phase 2b enrollment in December 2024, and the company has also developed additional DFCs for oncology, including CBO421, which targets CD73 in solid tumors and received IND clearance in July 2024 [3]