Cidara Therapeutics, Inc.

Good day and welcome to the Sedera Therapeutics Q3 2025 conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touch-tone phone. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Brian Ritchie with LifeSci. Please go ahead.

Thank you, Operator, and good afternoon, everyone. With me today on the phone from Sedara Therapeutics is Dr. Jeff Stein, President and Chief Executive Officer. Following Dr. Stein's prepared remarks, he will be joined by Mr. Frank Carba, Chief Financial Officer, Dr. Nicole Darrapana, Chief Medical Officer, Dr. Les Tari, Chief Scientific Officer, and Mr. Jim Beidle, Chief Business Officer, to participate in a Q&A session. Earlier this afternoon, Tadar released financial results and a business update for the third quarter ended September 30th, 2025. Both the press release is available on the company's website. Please note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. Management will be making forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially. These statements are qualified by the cautionary notes in today's press release and the company's SEC filings. This call contains time-sensitive information, accurate only as of today, November 6, 2025. DARA undertakes no obligation to revise or update any forward-looking statements. With that, I'd like to turn the call over to Jeff Stein. Jeff?

Thank you, Brian, and thank you all for joining us. We are pleased to report another very productive quarter at Sidero. Our lead candidate, CD388, has advanced into Phase III development on an accelerated timeline, in addition to other notable achievements, including the expansion of the patient population for our Phase III trial receipt of breakthrough therapy designation from the FDA, and securing funding from BARDA for this program. As with prior calls, we'll focus our remarks on clinical and corporate updates. As a non-revenue generating company, we will not have a dedicated section to review our quarterly financial results on this call, but instead refer you to today's press release and 10Q filings. Cidera's proprietary Cloudbreak platform has been developed as a fundamentally new approach to treat and prevent serious diseases through the development of novel drug FC conjugates, or DFCs, a new class of therapeutic that combines the precision of small molecules with the durability of antibodies. Our lead candidate, CD388, is a highly potent, long-acting antiviral designed to deliver universal, once-per-season prevention. of seasonal and pandemic influenza by directly inhibiting viral proliferation. Its enhanced antiviral potency and durability make it a potentially transformational non-vaccine preventative of influenza that overcomes the limitations of existing vaccines and antivirals. A key accomplishment during the third quarter was the start of our phase three anchor trial six months earlier than originally planned. This trial will evaluate the safety and efficacy of CD388 in populations at high risk for complications from influenza. Based on feedback from the FDA in our end-of-Phase II meeting, we believe that the ANCHOR trial, if successful, may support potential BLA approval of CD388 in the study populations examined in both the Phase IIb Navigate study as well as the Phase III ANCHOR study. The ANCHOR trial was started in late September following a constructive end-of-phase meeting with the FDA at the end of August. Initiation of the study triggered a $45 million milestone payment to J&J, which was booked in Q3 but will be paid in Q4. Originally, we planned to enroll participants aged 12 years of age and older with moderate to severe comorbidities, as well as subjects who are immunocompromised. However, based on FDA feedback, we expanded enrollment to include healthy adults over 65, a large and growing group that is poorly protected by current influenza vaccines due to age-related declines in immune function. This change has two important implications. First, it more than doubles the initial number of patients who would potentially be eligible to receive CD388 from 50 million to well over 100 million people in the U.S. Second, it has helped facilitate faster enrollment. The study began in the northern hemisphere in late September. The primary endpoint is based on laboratory-confirmed influenza, body temperature of 37.2 degrees centigrade, or 99 degrees Fahrenheit, or greater, and new or worsening of either two respiratory symptoms or one respiratory symptom and one new systemic symptom. We plan to enroll 6,000 participants in 150 sites, nearly three times the number of sites we used in the Phase IIb Navigate study. All sites are now active, and the study is over 50% enrolled, on track to achieve target enrollment in the Northern Hemisphere by December. An interim analysis, most likely in late Q1 2026, will assess the trial size powering assumptions, and event rate to determine if it is necessary to enroll participants in the Southern Hemisphere in the spring of 2026. CD380's progression into Phase III is supported by the strength of the compelling data from our Phase IIb Navigate study, which met its primary endpoint, demonstrating statistically significant prevention of efficacy and a benign safety profile in all three doses tested. Importantly, the NAVIGATE study showed that a single 450 mg dose of CD388 provided 76.1% protective efficacy that extended through the entire flu season. We shared additional NAVIGATE data at key scientific meetings this fall. The data presented continued to reinforce CD388's differentiated profile as a long-acting, broad-spectrum antiviral for influenza prophylaxis. The pharmacokinetic data for the 450 mg dose demonstrated sustained serum concentrations well above the targeted therapeutic threshold, supporting protection through the full flu season with a single 450 mg dose in both influenza A and B strains, paired with a clean safety and tolerability profile including low rates of injection site reactions, which further differentiate CD388 from vaccines. These results validate our dose selection for phase three. Taken together, these findings strengthen our conviction that CD388 can offer clinically meaningful protection in populations at high risk for flu complications, independent of host immune status, setting it apart from both vaccines and currently approved antivirals. In early October, the FDA granted CD388 breakthrough therapy designation, recognizing preliminary clinical evidence of substantial improvement over existing options. The advantages to Sydera will be enhanced access to the FDA, including more frequent guidance, rolling data review, and eligibility for priority review, all of which may accelerate development and regulatory timelines. CD388 also holds fast-track status, and this latest recognition affirms the quality and promise of the clinical data we have generated. Also in October, we received an award valued up to $339 million from the Biomedical Advanced Research and Development Authority, or BARDA, to support expanded manufacturing and clinical development of CD388. The multi-year agreement is structured to include a base period and additional option periods. The base period, valued at $58 million over the first 24 months, will fund the onshoring of manufacturing to the United States, expanding our initial commercial supply chain. It will also support several important development activities, including a clinical trial to demonstrate comparability for a higher concentration formulation and alternative product presentations, non-clinical studies to further characterize CD388's activity against pandemic influenza strains, and early work on clinical trial protocols for expanded populations. The option periods could provide up to an additional $281 million in funding to support further clinical and non-clinical studies of CD388 in targeted patient groups and broader population settings. Thanks to our successful financing in June, we remain in a strong financial position. With approximately $476 million in cash at September 30th, Our Phase 3 development program is fully funded through completion in all scenarios, including potentially expanding the study to the southern hemisphere if needed. Before closing, I want to highlight that we plan to host a virtual R&D day for the investment community on December 15th. We'll provide a detailed update on the CD388 program, including enrollment progress, and we'll share insights from recent market research on the commercial opportunity for CD388. Further details will be announced shortly, and we look forward to your participation in this event. With that, I will turn it back to the operator to take your questions. Operator?