Greetings. Welcome to Cidara Therapeutics to announce its positive top-line results from its phase II-B Navigate trial evaluating CD388, a non-vaccine preventative of seasonal influenza. At this time, all participants will be in listen-only mode. A question-and-answer session will follow today's formal presentation. If anyone should require operator assistance during the conference, please press star zero from your telephone keypad. As a reminder, this conference is being recorded. At this time, I'll hand the conference over to Brian Ritchie with Investor Relations. Brian, you may now begin. Thank you, Operator. Good morning, everyone. With me today on the phone from Cidara Therapeutics are Dr. Jeff Stein, President and Chief Executive Officer, and Dr. Nicole Davarpanah, Chief Medical Officer. Following Dr. Stein and Dr. Davarpanah's prepared remarks, they will be joined by Mr. Frank Karbe, Chief Financial Officer, Dr. Les Tari, Chief Scientific Officer, and Mr. Jim Beitel, Chief Business Officer, to participate in a Q&A session. Earlier this morning, Cidara released top-line results from its phase II-B Navigate trial evaluating CD388 for prevention of seasonal influenza. A copy of the press release and slides that will be shared during this call 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, Cidara management will be making 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 Cidara's press release issued today and the company's SEC filings, including in the company's annual report on Form 10-K for the fiscal year ended December 31, 2024, and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, June 23, 2025. Cidara 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? Thank you, Brian, and thank you all for joining us on this call. We could not be more excited to share and discuss the positive top-line results from our phase II-B Navigate trial. For your convenience, the slides from today's discussion are available on our website. Before we begin, let me remind everyone that Cidara's proprietary Cloudbreak platform is designed to enable the development of novel drug-Fc conjugates, or DFCs, a fundamentally new class of drug that combines the strength of small molecules with those of monoclonal antibodies. Our lead asset, CD388, is a long-acting antiviral drug that was designed to provide once-per-season protection against all strains of influenza in all people, regardless of immune status. Its unique properties have been shown to substantially enhance its antiviral activity, making it a potentially best-in-class neuraminidase inhibitor that overcomes the limitations of existing vaccines and antivirals. Before I hand it over to Dr. Davarpanah to discuss the details of the Navigate phase II-b top-line results, I would like to provide a brief summary of the data. Also, as a reminder, today we are sharing the top-line results comprised of key efficacy and safety tables needed to determine the success of the study. Additional results on pharmacokinetics, biology, and longer-term safety from the Navigate trial needed to inform final dose selection for phase III are expected to be disclosed at upcoming scientific conferences in 2025. With that said, we are delighted to share that the Navigate study met its primary endpoint, prevention efficacy, or PE, of protocol-defined influenza-like illness events at 24 weeks and was statistically significant at each dose group. Single doses of 450 milligrams, 300 milligrams, and 150 milligrams of CD388 confirmed 76%, 61%, and 58% protection, respectively, from symptomatic influenza over 24 weeks compared to placebo. The placebo attack rate was 2.8% for the primary endpoint, which means that 2.8% of subjects in the placebo group contracted an influenza infection that met the criteria for the primary endpoint. Moreover, all secondary endpoints were also met with statistical significance in each dose group. The safety and tolerability data were consistent with prior studies of CD388 and similar in all arms of the study, with no safety signals observed. While we observed a clear dose-response relationship for efficacy, there were no meaningful changes in safety across the dose groups and placebo. Loss-to-follow-up rates were low and similar in all arms. We believe these results are groundbreaking for the field of influenza and support our confidence in the potential of CD388 to offer robust once-per-season protection against influenza A and B. I would like to now turn the call over to Nicole, who will further discuss the Navigate phase II-B study and top-line results. Nicole? Thank you, Jeff, and thank you to everyone joining our call today. As a reminder, our Navigate phase II-B study is a blinded, randomized control trial evaluating the efficacy and safety of CD388 as a single subcutaneous administration for the prevention of seasonal influenza in healthy unvaccinated adults aged 18 to 64 not at risk for influenza complications. The trial enrolled 5,041 participants from the last week of September 2024 through the first week of December 2024, with the majority of participants being dosed prior to the onset of the 2024-2025 Northern Hemisphere influenza season. Participants were equally randomized across three CD388 dose groups: 150 milligrams, 300 milligrams, or 450 milligrams, and one placebo group in 58 clinical sites in the United States and United Kingdom. The primary endpoint was prevention efficacy, or PE, of influenza-like illness events, which was defined by three criteria: PCR-confirmed influenza, two respiratory or one respiratory and one systemic sign or symptom, and body temperature greater than or equal to 38 degrees Celsius. PE tells us the percentage by which a prevention method reduces the chance of getting seasonal influenza compared to not using it. The primary analysis included all data available as of April 30, 2025, and today we are sharing top-line data as of that data cutoff. Before I review the results, I'd like to remind everyone that the Navigate study was initially designed primarily to determine dose selection for phase III studies and was not powered for statistical significance. Prior to study start, we had predicted that 2% of participants in the placebo arm would develop influenza illness. However, as a result of the severity of the 2024-2025 flu season, our assumption was that the incidence of influenza in placebo arms might be somewhat higher, in the 2%-3% range. We discussed and reached agreement with the FDA on modifications to the study's statistical analysis plan to evaluate potential statistical significance of CD388 efficacy versus placebo. The top-line data that we are sharing with you today reflects that revised statistical plan. Now on to the top-line results. Let's start with efficacy. The study met its primary endpoint, demonstrating highly statistically significant protection efficacy data for each of the three dose groups compared to placebo over 24 weeks. The number of subjects with protocol-defined influenza-like illnesses, or ILIs, was lower in each of the three dose groups, ranging from 0.7%-1.2% when compared to a placebo attack rate of 2.8%. Importantly, as I mentioned, PE tells us the percentage by which a prevention method reduces the chance of getting seasonal influenza compared to not using it. As you can see, regardless of the CD388 dose, the protection against influenza illness was impressive, with greater than 76% at the 450 milligram dose. This tells us that subjects who were dosed with 450 milligrams of CD388 have a 76% lower chance of getting seasonal influenza compared to those who received placebo. At the 150 milligram and 300 milligram doses, the chance of getting seasonal influenza was also substantially decreased in over half of the subjects. For perspective, the prevention efficacy data for each of the CD388 dose groups exceeds the average vaccine effectiveness of approximately 40% for the seasonal vaccine. These are promising data for the potential of CD388 to provide influenza protection. I would also highlight that the confidence interval, or CI, is narrow, and the lower bound of the CI is well above zero, giving us statistical confidence in this data. Moreover, the P value for the 450 milligram dose was highly significant at a level of less than 0.0001. All secondary endpoints were also achieved. This includes maintenance of statistically significant prevention efficacy data up to 28 weeks, approximately seven months. The key secondary endpoints displayed here utilize the same definition as the primary endpoint, which is PCR-confirmed influenza and respiratory or systemic signs or symptoms, but with different temperature thresholds. These temperatures are historical fever definitions utilized in previous vaccine and antiviral clinical trials. The CDC definition of an ILI utilizes a temperature of greater than or equal to 37.8 degrees Celsius. As we see in the top half of the table, at the 37.8 degrees Celsius temperature threshold, each dose group demonstrated statistical superiority to placebo with prevention efficacy of 76.1%, 55.3%, and 54.7% for the 450 milligram, 300 milligram, and 150 milligram doses, respectively. Prevention efficacy superiority was also statistically significant to placebo at temperatures greater than or equal to 37.2 degrees Celsius temperature threshold and demonstrates that regardless of temperature cutoff, prevention of febrile influenza was statistically significant and impactful. We believe it is particularly impressive that the P values for both the primary and secondary endpoints demonstrated clear statistical superiority. Now on to safety. The safety and tolerability data were similar in all arms, with no safety signals observed and no drug-related serious adverse events observed. There were no unexpected dose-limiting treatment emergent adverse events between CD388 and placebo groups. Importantly, treatment emergent adverse events showed no dose-dependent pattern between the CD388 and placebo arms. The majority of treatment-related AEs were unrelated to CD388 and were grade 1 or 2, meaning that they were mild or moderate in nature. While cross-study comparisons should not be considered definitive, the adverse events that frequently occur with other neuraminidase drugs, such as oseltamivir and zanamivir, were seen in the Navigate study with lower frequency. For example, in the U.S. prescribing information for zanamivir reported for the 28-day prophylaxis studies, a common adverse event was headache, reported in an incidence of 24%. In the Navigate trial, headache was observed with an incidence of 2.3% in the CD388 450 milligram dose arm. Cough was observed in an incidence of 17% in zanamivir prophylaxis studies, while it was observed in an incidence of 2% in the CD388 450 milligram dose arm. Nausea/vomiting and diarrhea were observed at incidences of 2% and 2%, respectively, with zanamivir. In Navigate, nausea, vomiting, and diarrhea were observed at incidences of 0.6%, 0.2%, and 0.4% in the CD388 450 milligram dose arm, respectively. Additionally, injection site reaction rates were similar across all CD388 dose groups and placebo, including erythema, induration, pain, and tenderness. These were participant-reported reactions within eight days of subcutaneous administration. This is another important distinction from vaccines which are administered intramuscularly and for which injection site reactions are common. Finally, as you can see here, the enrollment of the study was well-balanced in terms of age, gender, and race across the treatment and placebo arms. I would like to add that we expect to present additional results from the Navigate trial at upcoming scientific conferences later this year. With that, I would like to turn the call back over to Jeff for next steps and closing remarks. Jeff? Thank you, Nicole. The statistically significant and clinically meaningful results shown with CD388 mark a potential breakthrough for patients and the future of influenza protection, as well as further validation of our Cloudbreak DFC platform. Results such as these are unprecedented in influenza and support our confidence in the potential of CD388 to offer robust once-per-season protection against influenza A and B for high-risk individuals, such as those with compromised immune systems or those at a heightened risk of severe illness due to underlying health conditions. Based on these robust data, we submitted our end-of-phase II meeting request to the FDA to review the data and discuss the details of a phase III study focusing on large populations with the highest unmet need, which includes 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 and antiviral drugs. Drug supply is available for any of the three doses we select to start phase III. With that, and on behalf of everyone at Cidara, I would like to thank all of our collaborating partners for their dedication and hard work to reach this milestone, and the individuals whose participation helped us execute this important study and achieve these stellar results. I will now turn it back to the operator to take your questions. Operator? Thank you. We'll now be conducting a question-and-answer session. If you'd like to ask a question at this time, please press star one from your telephone keypad, and a confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to withdraw your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions. Thank you. The first question is from the line of Eric Schmidt with Cantor. Please proceed with your questions. Hello. This is Michael [Dao] on for Eric Schmidt with Cantor. We'd like to extend our congratulations for this exceptional outcome. A quick question from us. Assuming FDA sign-off in August, is there any reason why you could not start the phase III trial in the fall this coming flu season? Thank you. Thank you, Michael. Our guidance still remains that we will start the phase III study in the spring of 2024. Southern hemisphere. That said, we will be meeting with the FDA in the next one to two months, and we will have that conversation. As of this time, we have not changed our guidance. Thank you. The next question is from the line of Seamus Fernandez with Guggenheim Partners. Please proceed with your questions. Great. Thanks for the questions. First off, just congratulations on the great data. Maybe, Jeff, can you confirm for us, I think the automatic assumption is that you'll be advancing the 450 dose into the phase III program. Just hoping to get a better understanding of your advancement towards a commercial presentation and what that commercial presentation ultimately might look like, I think, given the fact that currently you're still in the sort of 150 milligram prefilled syringe presentation at this point. Just wanted to get a little bit of clarity on that. The second question is on prospects for engaging with BARDA prior to sort of a turnover of the budget from September of this year. Is there and do you see an opportunity to engage with BARDA sooner rather than later as an opportunity to capitalize on potential non-dilutive incremental non-dilutive financing? Thanks. Sure, Seamus. Thanks for the questions. With respect to the first question on the dose presentation, at our recent R&D day, we spoke at length of our development work that is ongoing with CD388, which includes the potential change from prefilled syringe to a single-use vial and the potential for a higher concentration dose. We are still undergoing that work. We expect to start our phase III study with the same 150 milligram one-mill prefilled syringe. That said, the ongoing development work is still advancing, and at some point, we will evaluate the opportunity to change that to a commercial presentation. With respect to the second question on BARDA, we had also announced at that R&D day that we have already started engagement with BARDA. We have not had the opportunity yet to sit down with them and meet to review the phase II-b results we just disclosed this morning, but you can certainly expect that we will be doing that in the near future. There is no reason for me to expect that they would not be interested in the results, and we look forward to that engagement. Great. Maybe just a couple of additional questions. First, on the strains that we could learn going forward, what would be sort of the targets for additional data that you think will be important at subsequent medical meetings? I think there were two things that we've talked about in the past. One is just sort of the PK relationship relative to dose over time and the efficacy there, and then additionally, maybe a strain analysis of the different flu strains as a separate opportunity. Just interested to know which of those analyses and when we might see those analyses at future medical meetings. Sure, Seamus. Yes, the PK data, which includes the time course for when infections occurred in each dose arm, as well as the strain-level information from the Navigate phase II-b study, will be available by this September. There are medical conferences that start in September, and we will be submitting those results in time for those conferences. Great. Thanks for the questions. Congrats again on the phenomenal results. I'll jump back into you. Thanks, Seamus. Our next questions are from the line of Brian Abrahams with RBC Capital Markets. Please proceed with your questions. Hey, good morning, guys. Thanks for taking my questions, and my congratulations as well on the data. Realizing that this is pending FDA discussions, but I'm just curious, given the effect size you're seeing here, but also the potential for variability and severity of the flu season, any updated thoughts on how you might be thinking about the design and powering of pivotal studies here? Does the data here change your view on, I guess, how rapidly you might go beyond the high-risk comorbid and immune-compromised population and potentially explore broader populations, including in combination with vaccination? Sure, Brian. Again, both important questions. We will be, at our end-of-phase II meeting, we will be meeting with the FDA to discuss the phase III design. Nicole, perhaps you can address what we have previously disclosed about our interactions with the FDA with respect to the phase III study expectations. Hi. Thank you, Brian, for the questions, and thank you, Jeff. Yes, as we relayed in our R&D day, the assumptions for the phase III trial that we shared with the FDA were, in effect, a size of 60% with 90% powering, a placebo background attack rate of 1.5%, and 10% loss to follow-up. As you can see from the trial results today, that provides us an adequate margin and sort of a buffer, essentially, for the results of the phase III and how the phase III would turn out in a different population. Moving forward, of course, we will be allowing vaccination; that is the standard of care for the phase III population, but vaccination will be optional. We will be able to evaluate essentially two subgroups: those who have received vaccine and those who have not, in combination with CD388. Got it. That's really helpful. Maybe just a quick follow-up. I'm not sure if all these data have been analyzed yet, but did you see any differences with regards to age or region in terms of preventative activity in this study? I'll hop back into you. Thanks. Nicole, maybe you can just highlight. Oh, sorry. Thank you. Yeah. Thank you. Thank you. Thank you. Yes, we have not analyzed the individual subgroup data in great detail yet, but we will have that publication and presentations in the early fall. Fair enough. Thanks again, and congrats again. Our next questions are from the line of Joseph Stringer with Needham & Company. Please proceed with your questions. Hi, good morning. Thanks for taking our questions. Two from us, sort of follow-up questions. Understanding that you have an end-of-phase II meeting with the FDA coming soon, but is it your current understanding that this phase II- B could serve as one of the two required pivotal trials needed for registration, and would you get confirmation of that in your end-of-phase II meeting? Secondly, on the thoughts about dose selection, it seems likely that you'd go with the single dose, the high dose for phase III, but just curious your thought process for potentially, if you were considering the 300 mg dose, the mid-dose, maybe just thoughts around why you could do that, and maybe some initial thoughts on dose selection. Thank you. [Sure, Joy]. I'll take the second question, and I'll let Nicole address the first, and to remind everyone what we've previously disclosed regarding our recent type C meeting with the FDA. With respect to dose, I think you've interpreted it correctly. We have flexibility to select any of the three doses. Traditionally, as you know, in clinical trials, you tend to go with the highest dose so long as there's no safety limitation or tolerability issues. Certainly, that's the case that we have here. Then comes a question on the commercial presentation. We're evaluating that. We are blessed by the fact that any of the three doses would likely be well-suited for the phase III study, but the final dose selection will be dependent on our final analysis of the pharmacokinetics and the virology data, which we expect to have in the coming weeks and months, and we'll be disclosing in September. Nicole, do you want to address what we have previously discussed at the R&D day with respect to the type C meeting? Yes, thanks for the questions, Joseph. As you know, we had had discussions with the FDA on what are the requirements for this to count as a registrational trial, as this was an adequate and well-controlled trial by kind of FDA guidance definitions. They relayed to us that that would depend on the data. We are excited to share this data with them at the end-of-phase II meeting and be able to provide an answer to that too. Great. Thank you for taking our questions. The next questions come from the line of Roy Buchanan with Citizens. Please proceed with your questions. Hey, thanks for taking the question, and kudos to the clinical and research teams. It's nice to see something novel that works. I guess, can you remind us what the primary analysis that was used in the trial was? Was it a modified boson regression? And then it looks like the dropout rate in the overall study was about 6.8%. Is that correct? Yeah, Nicole, you can address those. The analysis for this was, as we had mentioned, a hierarchical analysis. We had done a grouped dose analysis of the 300 and 450 milligram doses first. That met full statistical significance, and we've then moved on to individual pairwise analysis for each dose group versus placebo based on the Hochberg method, as I believe the slides indicate that in the R&D day slides from May. In terms of your second question for loss to follow-up, you're exactly right. It was approximately 7% loss to follow-up, imbalanced in all arms and placebos. Okay, great. Were you any surprised at the, I guess, limited drop-off going from the 38 degrees Celsius fever to the 37.8 degrees Celsius threshold? Looks like it was sub 5%. Did that surprise you at all? Actually, our only kind of reference for that would be the VIR trial, where there seemed to be a bit of a jump with each temperature as you go from more events. I think there were just so few events in the 450 milligram dose. As you can see, those numbers were exactly the same for 38 and 37.8. I think because of that, those individuals had the fever cut off that the CDC utilizes, and that provides us kind of a lot of confidence with all the temperature thresholds having met what they would have all met, essentially, the primary endpoint. Okay, perfect. Thanks. Maybe I'd like to ask one more. I know the populations are going to be different and vaccinated versus non, etc., but if you apply the proposed phase III primary endpoint criteria to the phase II- B, what would the placebo attack rate have been? Thanks. I think the closest assumption that we have for that would be the 37.2, and the placebo attack rate there was 3.5%. We would assume it would be between 3.5% and 4% without any fever at all. Got it. Thank you. As a reminder, if you'd like to ask a question at this time, you may press star one from your telephone keypad. The next question is from the line of Steve Brozak with WBB Securities. Please proceed with your questions. Hey, good morning and congrats. I've just got one question here. You've looked at and said that the data is unprecedented, and I think everyone can look at vaccine efficacy and say the same thing. There's a difference here. You're agnostic in terms of flu strain and also immunocompromised status. How would you define the difference in your words, and what is the difference as far as future developmental work for what you have and what the normal vaccine protocols would have as far as influenza strain sensitivity? I'll hop back into you. Thank you. Sure, Steve. Thanks for the questions. If I'm interpreting that correctly, you're asking how we are defining unprecedented, and certainly, it's consistent with what you mentioned. CD388 combines the strength of not only small molecules and monoclonal antibodies, but also has that potential for a once-per-flu-season administration. There are certainly antivirals that have the same broad spectrum, including zanamivir, which is a version of which is a component of CD388. Those are not dosed once per season. It is really the combination of all the favorable attributes of these other modalities that have been consolidated within CD388 that enables us to say with confidence that these results are unprecedented. Great. Perfect answer. Thank you. Back into you. Thank you. At this time, we've reached the end of the question-and-answer session. I'll turn the call over to Dr. Jeff Stein for closing remarks. Thank you all for joining us today. We greatly appreciate your interest in Cidara and hope that you can join us for our second quarter earnings call in August. Enjoy the rest of your day. Thank you. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.