Cidara Therapeutics, Inc.

Greetings. Welcome to SADARA's Q1 2025 earnings call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. Please note, this conference is being recorded. I will now turn the conference over to Brian Ritchie of LifeSci Advisors. Thank you. You may begin.

Thank you, Operator, and good afternoon, everyone. With me today on the phone from Sedara Therapeutics are Dr. Jeff Stein, President and Chief Executive Officer. Following Dr. Stein's prepared remarks, he will be joined by Mr. Frank Carby, Chief Financial Officer, Dr. Nicole Daurapana, 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, Sadara released financial results and a business update for the first quarter ended March 31st, 2025. A copy of the press release and corporate presentation are 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. We caution listeners that during this call to DARA management forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in SADARA's press release issued today and the company's SEC filings, including in the annual report on Form 10-K and subsequent filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, May 8, 2025. SADARA undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With that, I'd like to turn the call over to Jeff Stein.

Jeff? Thanks, Brian, and thank you all for joining us for our first quarter 2025 earnings call. Please note, given our upcoming virtual R&D day on May 22nd, I'll keep my remarks brief today. with the idea of sharing significantly more details around our ongoing CD388 clinical program at that event. Moreover, given our current status as a non-revenue generating company, and in an effort to keep today's prepared remarks as succinct as possible, we will not have a dedicated section to review our quarterly financial results on this call. Rather, I will point you to the press release and our 10-Q, which were filed today. With that, and since this is our inaugural quarterly earnings call, let me begin by reminding everyone that Cidera's proprietary Cloudbreak platform enables the development of novel drug FC conjugates, or DFCs, a fundamentally new class of drug that combines the strengths of small molecules with that of monoclonal antibodies. Our lead asset, CD388, we aim to revolutionize the prevention of influenza, which despite vaccines, has a mortality rate in the U.S. that is similar to breast cancer, colorectal cancer, and all blood cancers. CD388 combines a novel, multivalent presentation of the accrued antiviral small molecule drug, Sinamavir, with a human antibody fragment to prolong half-life. As an antiviral drug with universal activity against all flu strains, CD388 is not dependent on the host immune system for activity. and is thereby designed to have universal activity in all people, regardless of immune status. Its unique properties substantially enhance its antiviral activity, making it a potentially best-in-class neuraminidase inhibitor that overcomes the limitations of existing vaccines and antivirals. Details of CD380's preclinical data were recently published in the journal Nature Microbiology, These data highlight the potential of CD388 as a potent universal antiviral for influenza A and B prophylaxis in healthy and high-risk populations, regardless of immune status. This included activity against high pathogenicity strains like H5N1, also known as bird flu, as well as strains that are resistant to approved neuraminidase inhibitors. In April of last year, Cidera presented data at the 34th estimate conference from our phase one single ascending dose study of CD 388 which showed it to be well tolerated and with an extended half life supporting the potential of once per flu season dosing. We also presented data at this conference from our phase two a human challenge study of see CD 388 and healthy volunteers. The results showed that a single 150-milligram subcutaneous dose of CD388 provided substantial protective efficacy compared to placebo and supported the advancement of CD388 to a Phase IIb study. This 150-milligram dose is the lowest of three doses tested in our Phase IIb study. Our Navigate Phase IIb study evaluating the efficacy and safety of a single administration of CD388 for the prevention of seasonal influenza in healthy adult subjects was initiated the last week of September of last year. Dosing of 5,041 subjects was completed in the first week of December. Subjects were randomized across three CD388 dose groups, 150 milligrams, 300 milligrams, or 450 milligrams, and one placebo group. The primary analysis will include all available data as of April 30th, 2025, and you expect to announce top-line data by the end of June. The NAVIGATE study was initially designed primarily to determine dose selection for Phase 3, and it was not powered for statistical significance. However, as a result of the severity of the 2024-2025 flu season, we are discussing potential changes to the study's statistical analysis plan with the FDA to evaluate possible statistical significance of CD388 versus placebo. Dependent on the results of our Phase IIb study and our regulatory discussions, we expect to initiate a Phase III study in the spring of 2026 in the southern hemisphere. We plan to conduct our phase three study in high risk comorbid and immune compromised patients. We are focusing our efforts initially in these populations because they are disproportionately affected by influenza as evidenced by substantially higher rates of hospitalizations and deaths and are underserved by currently available vaccines or antiviral drugs. On May 22nd, we plan to host an R&D day The event will focus on a review of the 2024-2025 flu season, updates on our ongoing Phase 2b Navigate trial, updates on our regulatory discussions and our plans for a Phase 3 study, as well as insights into the unmet needs of influenza and the potential commercial opportunity for CD388. In closing, the data we have generated to date further validate our Cloudbreak DFC platform. and the potential of CD3-88 to offer universal protection against both seasonal and pandemic influenza strains. While vaccines play a vital role in flu prevention, they do not offer sufficient protection, particularly for immune-compromised individuals, underscoring the critical need for a durable, broadly acting antiviral like CD3-88. We look forward to the results of our Phase 2B clinical trial, continued discussions with the FDA, and the potential initiation of our planned Phase 3 study. With that, I will turn it back to the operator to take your questions.