Cidara Therapeutics (CDTX) Q1 2025 Earnings Call May 08, 2025 05:00 PM ET Company Participants Brian Ritchie - Managing DirectorJeffrey Stein - President & CEOSeamus Fernandez - Senior Managing DirectorJim Beitel - Chief Business OfficerNicole Davarpanah - Chief Medical Officer Conference Call Participants Eric Schmidt - Biotechnology AnalystGregory Renza - Director & Senior Analyst of Biotechnology Equity ResearchJoseph Stringer - Senior AnalystRoy Buchanan - Equity Research Analyst Operator Greetings. Wel ...

Cidara Therapeutics (CDTX) Q1 2025 Earnings Call May 08, 2025 05:00 PM ET Company Participants Brian Ritchie - Managing DirectorJeffrey Stein - President & CEOSeamus Fernandez - Senior Managing DirectorJim Beitel - Chief Business OfficerNicole Davarpanah - Chief Medical Officer Conference Call Participants Eric Schmidt - Biotechnology AnalystGregory Renza - Director & Senior Analyst of Biotechnology Equity ResearchJoseph Stringer - Senior AnalystRoy Buchanan - Equity Research Analyst Operator Greetings. Wel ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-36912 CIDARA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation ...

Exhibit 99.1 Cidara Therapeutics Provides Corporate Update and Reports First Quarter 2025 Financial Results SAN DIEGO, May 8, 2025 — Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak platform to develop drug-Fc conjugate (DFC) therapeutics, today reported financial results for the first quarter ended March 31, 2025, and provided recent business updates. ® "Coinciding with the end of the 2024-2025 flu season in the Northern Hemisphere, we have es ...

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]

Group 1 - The company Cidara Therapeutics (NASDAQ: CDTX) is initiating coverage with a Strong Buy rating, indicating a positive outlook for the stock [1] - Cidara has shifted its focus from antifungal treatments to its proprietary Cloudbreak drug Fc conjugate platform, suggesting a strategic pivot in its business model [1]

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]

Group 1: Company Overview - Cidara Therapeutics (CDTX) currently has a Momentum Style Score of B, indicating a positive momentum outlook [2] - The company has a Zacks Rank of 2 (Buy), suggesting strong potential for outperformance in the market [3] Group 2: Performance Metrics - CDTX shares have increased by 10.8% over the past week, outperforming the Zacks Medical - Biomedical and Genetics industry, which rose by 6.19% [5] - Over the past month, CDTX's price change is 11.63%, compared to the industry's 2.23% [5] - In the last quarter, CDTX shares increased by 5.39%, and over the past year, they have gained 76.29%, while the S&P 500 has moved -7.64% and 10.16% respectively [6] Group 3: Trading Volume - The average 20-day trading volume for CDTX is 162,652 shares, which serves as a bullish indicator when combined with rising stock prices [7] Group 4: Earnings Outlook - In the past two months, one earnings estimate for CDTX has moved higher, while none have moved lower, resulting in an increase in the consensus estimate from -$14.39 to -$7.12 [9] - For the next fiscal year, one estimate has also moved upwards with no downward revisions during the same period [9] Group 5: Conclusion - Considering all performance metrics and earnings outlook, CDTX is positioned as a 2 (Buy) stock with a Momentum Score of B, making it a potential candidate for near-term investment [11]

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]