8/7/2025

speaker
Dr. Jeff Stein
President & CEO

our confidence in the potential of CD3-88 to offer robust -per-season protection against influenza A and B. Based on these robust data, we submitted our -phase-2 meeting request to the FDA to review the data and discuss the details of a Phase 3 study. This meeting has been scheduled for later this month. Once we have received the meeting minutes from the FDA, we plan to disclose key details of our planned Phase 3 study, including study design, dose selection, and timelines. We have guided previously to initiate this study in the Southern Hemisphere in the spring of 2026. Pending feedback from the FDA, we are confident that we can meet that goal. But we are also operationally prepared to start the study this fall should this become an option based on the outcome of our -phase-2 meeting. If we are able to start Phase 3 this fall, we believe that the study will enroll over the course of two flu seasons, the 2025-2026 Northern Hemisphere and the subsequent 2026 Southern Hemisphere flu season. Following the initial flu season, we plan to conduct an interim analysis for potential trial resizing. In Phase 3, we plan to focus our efforts initially on large populations with the highest unmet need, which includes high-risk comorbid and immune-compromised patients because they are disproportionately affected by influenza, as evidenced by substantially higher rates of hospitalizations and deaths, and are underserved by currently available vaccines and antiviral drugs. Our plan to address these high unmet need populations is the basis for CD388's current fast-track and priority review designations. In addition, based on the strength of the Phase 2B results, we have submitted to the FDA an application for breakthrough therapy designation and expect to hear the outcome of this application later this year. I would also add that we have submitted a proposal to BARDA, which, if funded, could provide meaningful funding to support manufacturing and additional clinical development studies of CD388. We expect to learn the outcome of this submission also by the end of this year. As we prepare to advance CD388 into Phase 3, we do so from a position of significant financial strength, having recently closed an upsized public offering for gross proceeds of $402.5 million, which provides funding through the completion of our planned Phase 3 study. This funding also enables us to conduct additional supportive clinical and non-clinical studies, as well as additional market research, to further characterize the cost-effectiveness and commercial opportunities for CD388, both in the U.S. and -U.S. This includes work to highlight the burden of illness that influenza represents in our initial target population and the cost-offsets that could potentially be achieved with CD388. We plan to present the results of these activities in the coming months, following the conclusion of our discussions with the FDA regarding our Phase 3 plans. In closing, the data we have generated to date further validate our Cloudbreak DFC platform and the potential of CD388 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 need for a durable, broadly acting antiviral like CD388. We look forward to discussing our plan Phase 3 study design and trial start timeframe with the FDA shortly. With that, I will turn it back to the operator to take your questions.

speaker
Operator
Conference Operator

Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing any keys. To withdraw your question, please press star then 2. Our first question is from Sheamus Fernandez with Guggenheim Securities. Please go ahead.

speaker
Sheamus Fernandez
Analyst, Guggenheim Securities

Great. Thanks so much for the question. So just wanted to see if you can help us understand potential differences from the Type C meeting that you had with FDA and the planned Phase 3 design that you shared with us during your Analyst Day. If there are any potential changes or meaningful changes that you're proposing or if you're simply looking for your Pre-Phase 3 discussion to just clarify those particular points from the Type C meeting. Then just as a follow-up question on BARDA, I was hoping to get a better understanding of exactly what you would hope to achieve with the grant. I don't know if that's something that you can discuss at this point, but I think we have some idea. But it would be interesting to just hear how that exercise is advancing and what the prospects might be for BARDA. The last question that I have is would that evolve to potentially become something that could incorporate orders? It's unclear if the administration is currently concerned about bird flu or other influenza spreading, but just interested to know what it takes to kind of move forward to actually get to orders should the BARDA grant be issued. Thanks so much.

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