Morning everybody. Good morning, Jeff. Good morning, Frank. Thanks for joining us. I know it's bright and early on the west coast. We were hoping to have you here, but air traffic control I know made things a little bit more challenging for you guys. Really kicking off day number two here with Cidara Therapeutics. Jeff Stein, the CEO, Frank Karbe, the Chief Financial Officer, CMO. Say that again. He's listed as CMO, but oh my goodness. Yeah, that is not correct. Anyway, thanks for joining us, both of you. I think this is a great opportunity for everybody here to learn more about Cidara, a company that we're actually quite excited about. I've asked Jeff to just give a quick introduction to Cidara, where the company stands today and how you've built the organization to execute on this ongoing now phase III clinical program in influenza. Sure, Seamus, thanks so much and apologies for not being there in person. Both Frank and I did our best to get there, but we were daunted by the air traffic control situation, as you indicated. So Cidara, we're actually an 11-year-old company founded on what is called the Cloudbreak platform. The current incarnation of that platform is the Drug- Fc conjugate. We had been working on that for quite some time, but the current version was really invented in 2018 and the very first program emerging from that platform was CD388, our universal influenza preventative. More on that in a bit. In 2018, when we put this into preclinical testing, we were constantly surprised by the efficacy and safety of this modality. Typically in drug development one runs into roadblocks and you make adjustments. Here it was smooth sailing all along. The strength of that preclinical package enabled us to partner the program with J&J in 2021 in partnership. We put that into the clinic through two phase I studies and a phase II-A. The results of all of those studies were available end of Q1 of 2023 under our partnership agreement with J&J. They were preparing to exercise their option to take over the development of the program and put it into a large phase II-B and subsequently a phase III study. Shortly after they made that decision, John Reed came in as new Head of R&D and the organization decided to exit the infectious disease space. They started a series of divestitures of their ID program, starting with the latest stage going to the earlier stage programs. Ours was right in the middle of that process. These were big pharma to big pharma conversations for divesting these programs. We were able to compete in that very competitive process because we partnered with several top tier biotech investors and raised $240 million to compete and ultimately win back our asset. That was announced at the end of April of 2024. From that point we really had to sprint because we wanted to put this into the clinic. In a 5,000 participant phase II-B study in the fall of 2024, just a few months to hire a ClinOps team and get this thing up and running, we managed to do that. It turned out to be a very severe flu season. Last year we enrolled 5,000 participants testing three doses of CD388 versus placebo. Placebo controlled study with the ultimate objective of selecting a dose in April of 2025. Earlier this year we announced the results of that study that was called the NAVIGATE study and it succeeded beyond all expectations. We achieved the P. For our top dose we achieved a P value of less than 0.0001 versus placebo with a 76.1% efficacy rate which is unprecedented in any flu preventions. As a reminder, CD388 is not a vaccine. It often gets confused with vaccines because it's administered once a flu season, beginning of the flu season as a subcutaneous injection and it retains efficacy throughout the entire flu season. What also differentiates it from vaccines is that it is truly universally active against all strains of influenza and in all people, despite their ability to respond to vaccines. Because it's not a vaccine, it's a long acting antiviral drug with exquisite safety as well. Based on the strength of the data, we raised a round of financing to fund phase III. We are well capitalized through the entire phase III program. Now. We shared our results with the FDA in an end of phase II meeting. The FDA not only agreed with the phase III program, but they recommended we expand it. We initially contemplated advancing it into phase III in high-risk immunocompromised and immunocompromised populations. The FDA recommended we add another high-risk population, the over 65 population with either healthy or with mild comorbidities. We started that phase III trial the end of September, just a couple of months ago or a month and a half ago. We are on track to complete enrollment of that 6,000 participant study testing the 450 milligram dose CD388 versus placebo. We expect to complete enrollment by next month. Great, Jeff. I think we've covered a lot of the history of the program. Maybe we can focus in on the phase III design. Can you just remind us the sort of next points in time that are critical, you know, to the advancement of the study and some of the key decision points? You know, I know you just mentioned the timing of recruitment and the expectation for the completion of the trial, but the trial itself. Maybe you could just walk us through the interim look and then what you hope to achieve, the powering and the study. Yeah, absolutely. As I mentioned, this is a 6,000 participant—excuse me, 6,000 participants study testing the 450 milligram dose versus placebo. This is in a different population than the phase II-B. Phase II-B tested CD388 in healthy, normal, unvaccinated individuals from the ages of 18- 65. In the phase III, we're testing it in the high risk comorbid populations, the immune compromised and the over 65 population. It's a larger study. We are planning an interim analysis. One of the challenges of influenza studies is you can never predict the severity of the flu season. To answer your question on the powering of the study, the study is 90% powered to detect a 60% efficacy rate, assuming a 1.5% attack rate in the placebo arm. What is the attack rate? The attack rate is the rate in which the placebo recipients will show signs and symptoms of influenza based on our enrollment criteria. 1.5% is a very modest expectation, which presupposes a modest flu season last year. Not the population, but certainly the study was blessed with a historically severe flu season. The attack rate in the placebo arm in the large phase II-B study was 2.8%. To the extent the phase III exceeds a 1.5% attack rate in the placebo arm, the study will be even more strongly powered. However, since we do not know that we designed the study with an interim analysis. We expect to read out that interim analysis by the end of March of next year. What that will tell us is one of two things. Number one, the study is adequately powered and we can then expect to announce data in June. That would be top line efficacy data in June. Or if it's a modest flu season and it's not sufficiently powered with the 6,000 participants, the interim look will inform us how many additional participants we would need to enroll in the Southern hemisphere starting in May of next year. Okay, great. Maybe we can just take a step back to some of the details of the phase II study. One particular question is the differences from the phase II to the phase III. Any differences in the primary endpoint that you would point out? Differences in the patient population from the phase II that you would point out and what that could or how that might influence the results of the study. Sure, and it's an important question because we are going from a healthy normal population into immune compromised, high risk, comorbid and elderly where they do not have the same capability to respond to vaccines. Obviously this is not a vaccine, but still it's a different population with different issues. It'll be a much sicker patient population. You know, we expect that the results should be the same because, you know, we have two lines of evidence suggesting that will be the case. One, from our nonclinical studies which clearly show that in lethal mouse challenge models, the same dose of CD388 is equally efficacious in both the immune competent and immune compromised models. Second, and probably more importantly is that if you look at the labels of approved antivirals and especially the neuraminidase inhibitors such as zanamivir, which is really the active moiety on CD388 or Tamiflu, in those labels where those drugs were tested in high-risk populations, immune compromised populations and healthy normal populations, there is no dose adjustment. That is not too surprising because these again, they are not vaccines, they are antivirals. As long as there are no issues on differential clearance, one would expect that as long as you can maintain efficacious exposure, you will get the same result. Great. What about the inclusion of the vaccine? Remind us the percentage of patients that could be vaccinated and then also studies that have been conducted with other antivirals on top of vaccines. Yeah, important question because in this study we are allowing vaccines. Really the objective here is to test this in a real world situation. We're not mandating vaccines, we're recommending vaccination, but it's up to the individual and their physicians on whether they will be vaccinated in the study. We think this is important because again, you want to test this in a real world setting and see how CD388 will perform in both vaccinated and unvaccinated. Now, based on the severity of the comorbidities and the immune compromised and elderly, we expect that the majority of participants may be vaccinated. In fact, we estimate about 65% will be vaccinated now. I can speak to this later, but it's looking like it will be lower than that. That said, what we would ideally show is CD388 has additive activity on top of vaccines. The scientific rationale behind that is that vaccines, flu vaccines, largely generate antigens directed against hemagglutinin. There is one of two targets on the surface of the flu virus. CD388 targets neuraminidase and more precisely targets the active site of neuraminidase. Seamus, to your question, there was a study in 2017 with zanamivir in the clinic which showed that zanamivir has additive activity on top of vaccines. We expect to show the same thing. CD388 is 76% active. Vaccines on average are 40% active. We can anticipate that we may have an opportunity to show upwards of 90% protection. You know, that pretty much would be the holy grail of the universal influenza preventative. Great. I think that maybe brings us a little bit in the direction of, you know, the patient population itself and what the study is going to teach us about the individual populations and the powering of those populations within. In the phase III study, can you just help us understand, you know, 90% or greater than 90% powers for the overall population? What about sort of the subpopulations? Do you, have you guys shared the powering assumptions for the subpopulations or, you know, if you might be able to look at the individual groups separate and distinct. Distinct and perhaps even capture additional information in the label in that regard? Sure, yeah. The study is not powered to look at subpopulations individually. It is strictly the overall study population. We anticipate that approximately 40% of the participants will be in the high risk comorbid populations, moderate to severe comorbidities, approximately 10% in the immune compromised category and then 50% in the over 65 population. There are multiple populations and as you might imagine, in the high risk, there are subpopulations within that in cardiovascular, pulmonary and renal. You know, and so breaking that up, even though it's a large study, 6,000 participants, those subcategories are not individually powered for efficacy. This is based on the conversation we had with the FDA in our end of phase II meeting. Now, in that end of phase II meeting, the FDA indicated that our phase II-B study is a supportive study and could be part of the registration package and label. When you think about phase II-B population, healthy, normal, 18- 65 unvaccinated. The phase III study, the anchor study in the high risk comorbid immune compromised in over 65, the Antiviral Division has a history of providing a broad label which includes the populations tested in the registrational package. Okay, great. If you don't mind, I'm going to turn to Frank to talk a little bit about on the commercial opportunity. Frank, maybe you can just give us your general sense of how you're viewing the market opportunity and, you know, with, let's call it an expansive label with success of 388 in the phase III study, how do you break down the population and the opportunity? Yes, thanks, Seamus. We believe there will be well over 100 million patients that we expect to be eligible to receive CD388 per the now anticipated label. That includes about 50 million patients that have moderate to severe comorbidities or are immunocompromised. One might call these the patients that are perhaps at highest risk for complications from influenza. There is probably another 100 million patients that are still considered at increased risk from influenza per the CDC guidelines. That includes patients with mild comorbidities as well as the elderly, so patients above 65 that are otherwise healthy. Great. When we think about just sort of the pricing work that you've done historically, can you just remind us what you've, what kind of work you've done with payers and you know, perhaps maybe how we should be thinking about your next update to the market on December 15th at the upcoming analyst day? Yeah, so we have actually done quite a bit of market research now. There was an initial body of work that was conducted earlier this year and then more recently in the last couple of months we have really expanded that pretty significantly. At the R&D day in December, we plan to provide an update, particularly on this later market research that's focused on or that will cover a deeper analysis of the U.S. market, let's say, and I think it will provide a nice validation for the pillars of our commercial strategy and our conviction around the opportunity for CD388. There's maybe two things I would highlight here. On one hand, this includes our latest work with payers to more deeply characterize the pricing and access opportunities. It will also include an analysis of a very large database that includes insurance claims comprised of 200 million patients, where we're taking a deeper look at patients and prescriber segmentation within the patient populations that we're most focused on. I think that will be informative and again shed more light on how we plan to commercialize and why we are pretty bullish on the opportunities. Great. Maybe just to wrap up on that front, we only have a little bit of time left here. When you sort of think about the gating factors to being able to reach those 100 million patients, obviously, manufacturing is mission critical. Can you just update us on where we stand on the manufacturing side of things and what are the sort of key steps along the way from here to basically have high confidence that you can over time reach those 100 million patients? Yeah, so generally I'll just say that there are many different steps involved to get from here to ultimately having a BLA approved. As of now, all of these steps, I think are on target, on schedule, and I think everything's like progressing according to plan. One question that has come up, I think repeatedly over the last few weeks is how significant is the commercial supply that we're planning for? We've not really said this in detail, but I think you should take comfort in the fact that we are preparing to have multiple millions of doses ready at launch. And CMC, you've heard us say in the past, is a bit on the critical path and really is driving our timelines. We continue to evaluate whether we can further bring that in, but generally I would say every. All the different pieces here are proceeding according to plan. Okay, great. I would add to Frank's comments, and we didn't touch on this previously, but we also recently announced a large, large contract award from BARDA and the initial $58 million of that contract is to onshore manufacturing to stand up a parallel supply chain within the U.S. Frank was referring to our drug supply coming out of Wuxi. This will be a parallel supply chain and at some point we will be fully domestic in our commercialization. That will be very helpful in order to help us meet the commercial demand. Okay, fantastic. That was a great overview of the story. Lots of execution already completed along the way to hopefully certainly phase III results no later than 2027. Also looking forward to your December 15th analyst event and updates there as well. Thank you both for joining us. Very sorry to hear about the travel disruptions. You're not alone, that's for sure. Look forward to seeing you again soon. Take care and have a great morning. Thank you, Seamus. Thanks, everybody.