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Good afternoon, and welcome to the Cidara Therapeutics Second Quarter 2025 Earnings Conference Call. [Operator Instructions] Please note that the event is being recorded. I would now like to turn the conference over to Brian Ritchie with LifeSci Advisors. Please go ahead.

Thank you, operator, and good afternoon, everyone. With me today on the phone from Cidara Therapeutics is Dr. Jeff Stein, President and Chief Executive Officer. Following Dr. Stein's prepared remarks, he will be joined by Mr. Frank Karbe, Chief Financial Officer; Dr. Nicole Davarpanah, Chief Medical Officer; Dr. Les Tari, Chief Scientific Officer; and Mr. Jim Beitel, Chief Business Officer, to participate in a Q&A session. Earlier this afternoon, Cidara released financial results and a business update for the second quarter ended June 30, 2025. A copy of the press release and the company's corporate presentation are available on its company 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 annual report on Form 10-K and subsequent filings. This conference call also contains time- sensitive information that is accurate only as of the date of this live broadcast, August 7, 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 Dr. Jeff Stein. Jeff?

Thank you, Brian, and thank you all for joining us for our second quarter 2025 earnings call. We made substantial progress in the second quarter, most notably with the announcement of positive top line results from our Phase IIb NAVIGATE clinical trial, our subsequent $400 million financing and advancing our discussions with the FDA and BARDA regarding the further development of CD388. In an effort to keep today's prepared remarks as succinct as possible and given our current status as a non-revenue generating company, we will not have a dedicated section to review our quarterly financial results on this call and will not repeat in detail information that which has been previously discussed. Rather, I will point you to the press release and 10-Q we filed earlier today. With that, I will begin by reminding everyone that Cidara's proprietary Cloudbreak platform enables the development of novel drug- Fc conjugates or DFCs, a fundamentally new class of drugs that combines the strengths of small molecules with those of monoclonal antibodies. Our lead asset, CD388, is a once-per-flu season antiviral drug with universal activity against all flu strains and is designed to have universal activity in all people regardless of immune status. Its unique properties substantially enhance its antiviral activity, making it a potentially transformational universal preventative of influenza that overcomes the limitations of existing vaccines and antivirals. In late June, we announced the top line results from our NAVIGATE Phase IIb study, which evaluated the efficacy and safety of a single administration of CD388 for the prevention of seasonal influenza in healthy adult subjects. The study was initiated the last week of September of last year, and enrollment was completed with over 5,000 subjects in the first week of December 2024 before the peak of the flu season. Subjects were randomized across 3 CD388 dose groups and 1 placebo group. The primary analysis included all available data as of April 30, 2025. The NAVIGATE study was designed initially to determine dose selection for the Phase III study and was not powered for statistical significance. Prior to study start, we had expected based on historical flu season averages, that 2% of participants in the placebo arm would develop influenza illness. However, as the 2024-2025 flu season unfolded, we updated this forecast and predicted that the placebo attack rate could be sufficiently high for the NAVIGATE study to be powered for statistical significance. Based on this updated forecast, we discussed and reached agreement with the FDA on modifications to the study's statistical analysis plan to evaluate the potential statistical significance of CD388 efficacy versus placebo. The observed placebo attack rate in the NAVIGATE study was 2.8%, which enabled the detection of a statistically significant difference from placebo at each dose group. Single doses of 450 milligrams, 300 milligrams and 150 milligrams of CD388 confirm 76%, 61% and 58% protection, respectively, with p-values of less than 0.0001, 0.0024 and 0.005 at each dose, respectively. This is remarkable given the relatively small size of the study compared to vaccine studies. Importantly, the prevention efficacy data for each of the CD388 dose groups exceeded the historical average vaccine effectiveness of approximately 40% for a seasonal vaccine. 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. These and additional details of the full NAVIGATE top line results, including a replay of the data call, are available on our website under the Investors tab. We plan to present additional details from the NAVIGATE trial at upcoming scientific conferences later this year. We believe that 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. 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. 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 III study, including study design, dose selection and time lines. 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 end of Phase II meeting. If we are able to start Phase III this fall, we believe that the study will enroll over the course of 2 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 III, 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 IIb 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 III, 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 III study. This funding also enables us to conduct additional supportive clinical and nonclinical studies as well as additional market research to further characterize the cost effectiveness and commercial opportunities for CD388, both in the U.S. and ex 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 III 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 planned Phase III study design and trial start time frame with the FDA shortly. With that, I will turn it back to the operator to take your questions.

Our first question is from Seamus Fernandez with Guggenheim Securities.

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 III 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 sort of pre-Phase III discussion to just clarify those particular points from the Type C meeting. And 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?

Sure, Seamus. I'll provide some initial responses, and then I'll welcome Nicole Davarpanah to supplement. So regarding our upcoming meeting with the FDA and regards to your question, the difference from the Type C meeting, we don't have an expectation of substantial differences. We largely reached alignment with the FDA in our Type C meeting in our discussions regarding the Phase III plan. The difference is that meeting took place in May before the NAVIGATE Phase IIb results were available. Now that we have the results, this is the first opportunity to discuss those results within the context of the Phase III plan. Obviously, based on the strength of the Phase III data and the strong safety that we observed. We don't anticipate substantial differences from that discussion. Regarding BARDA, the -- as you are aware, when you submit these, there is a base period and option period. We have expectations that the base period will, if funded, would fund manufacturing, in particular, the onshoring of manufacturing to the U.S. Then there are various options for the option period that which exercised could result in substantial funding to support additional clinical studies. And then finally, regarding any orders from BARDA, that would come in the form of emergency use authorization in the event of a bird flu outbreak. We believe that based on the strength of the Phase IIb results, that would be an option should there be an outbreak. I would not anticipate a stocking order for CD388 in the absence of an emergency use authorization, however. So I'll invite Nicole to provide any additional color on those questions. Nicole?

Thank you, Jeff. I think you captured it quite nicely [indiscernible]. I think going back to the first point, we -- as Jeff mentioned, we had a significant amount of alignment with the FDA on our trial population, the study design and endpoints. But of course, that was before the benefit of having this nice Phase II data. So we will then have this meeting currently to kind of align with them further in case there's any changes, which we do not anticipate to the study design. And once we have received the meeting minutes, we will share openly any changes that have potentially been made.

The next question is from Eric Schmidt with Cantor Fitzgerald.

Congrats on just a wonderful second quarter. Maybe just to continue Seamus' line of discussion around the upcoming FDA meeting, I assume first it's in August because I think you need to schedule those within 60 days, so you can correct me if my time lines are off. But how would you plan to update investors on the outcome from that meeting? What actual points of discussion or questioning do you plan to put forth to the FDA? And then do you also plan to submit for a commissioner voucher? It would seem that CD388 might be a good fit for a national priority.

Sure, Eric. Yes, all good questions. As discussed in the response to Seamus' question regarding the FDA meeting, this is the first opportunity really to discuss with them the Phase III plan in the context of the Phase IIb data. That meeting has been scheduled, and we expect that it will occur by the end of this month. In response to your question about communication of the outcome of that meeting, we will await the receipt of the FDA minutes and then communicate those results and the results of those minutes in detail. With respect to your other question, I think about the CMPD voucher, we have submitted a statement of interest to -- it was a 350 word statement of interest, and we have yet to receive a response. I agree that CD388 would appear to be a very good fit. And was there another question, Eric, that I missed?

I think you got it, unless you're willing, Jeff, to talk a little bit more about what you want to hear from the agency in your pre-Phase III meeting before having a go decision on the season.

Yes. And again, I'll respond, and then I'll invite Nicole to provide any other color. Really, it's to corroborate the agreement we reached in our Type C meeting. So we haven't disclosed the details of that because obviously, that can change based on the end of Phase II meeting. So we will discuss those results when they become available in the form of the meeting minutes from the FDA. We don't anticipate substantial changes because the results of the NAVIGATE study were pretty much in alignment with the expectations that we discussed with the FDA in the Type C meeting. Nicole, any other color you would like to add to that?

Thank you, Jeff. No, nothing further to add.

The next question is from Brian Abrahams with RBC.

This is Nevin on for Brian. I just wanted to follow up on -- a little bit more on the Phase III design that you proposed. So you're planning to enroll a more immunocompromised high-risk population. So could there be a greater chance that the trial could reach the needed number of events earlier than the NAVIGATE trial had reached those events? And can you explain some of the reasoning behind enrolling the trial over 2 to 3 influenza seasons, is that just the 1 season as the NAVIGATE trial? And then could you also remind us on the evidence that you've generated to date that suggests 388 can be redosed? And then do you imagine that regulators would want to see redosing potential -- potentially in the pivotal trial?

Sure. Yes. Good questions. Can you repeat the first question, please?

Yes, of course. So just given that the population that you're planning to enroll is more immunocompromised and high risk, do you think that there's a greater chance that the trial could reach that -- the needed number of events sooner than the NAVIGATE trial had?

Yes. Great question. Actually, we believe the opposite that the attack rate in the placebo arm of the study will be lower than that in the Phase IIb. And the main reason for that is even though -- and I think what your question was alluding to is that this is a more vulnerable patient population. At the same time, they are a more protected patient population. And so they go because of the inadequacy of vaccines and protecting these patients, they are highly protected and also a big difference is that we believe that at least half, if not more, of these subjects will be vaccinated. Even though the vaccine effectiveness will be modest at best, it does offer some protection. In regard to your other question on redosing, yes, we do anticipate conducting a redosing study that is planned. And it's basically a continuation of redosing that we had conducted in our first Phase I study where we are looking for antidrug antibodies. We didn't see any substantial evidence of that. We also looked for those in the Phase IIb study. But we have this great resource in the subjects we enrolled in the NAVIGATE Phase IIb study that have received a dose -- 3 different doses of CD388. So we're going to take advantage of that resource and take a subset of those subjects for a redosing study that we anticipate starting shortly.

Okay. And then what do you think the time lines for that would be? Would that be kind of prior to the initiation of the pivotal trial or just...

Yes, we will -- good question. We'll communicate that after we receive the meeting minutes from our upcoming end of Phase II meeting because we'll be discussing that with the FDA.

The next question is from Joseph Stringer with Needham & Company.

This is Eddie on for Joey. Just two from us. First, just to kind of a follow up on the previous question. I'm wondering what assumptions are built into that cash runway? And does this include that redosing trial as well as the potential for a second Phase III trial? And then a follow-up, just looking at the landscape, Sanofi guided for mid-teen percent declines in their food business this year, partly due to the U.S. pricing pressures. Just curious what the -- what read-through might be possible for your business and maybe some commercial outlook for CD388.

Sure. For the first question on cash runway, let me turn that one over to Frank Karbe, our CFO. Frank?

Yes, sure. So look, with the $500-plus million in cash on hand now, we believe we are adequately funded through the end of our Phase III program, including the additional studies that we have cited here on this call and also including different potential scenarios, how the Phase III could play out.

And then with respect to the second question, if you could repeat that, I know it was a commercial question regarding the Sanofi product, and I will turn that over to Jim Beitel, our Chief Business Officer. So if you could repeat that question first.

Yes, absolutely. Just on Sanofi's earnings call, they guided for a mid-teen percent decline this year in their approved business. And just seeing if there's any read-through to your business or commercial outlook for CD388?

Yes. Jim...

Certainly. Yes, I appreciate the question. And certainly, there's been a lot of downward pressure on vaccine businesses, I think not just Sanofi's but others as well. And a lot of that has to do with things unrelated to CD388. And I think it underscores the importance of our commercial strategy and development strategy, really focusing in on these subjects with the greatest risk. And there, the burden of illness is highest and the value proposition that we've demonstrated in the NAVIGATE study and intend to demonstrate in the Phase III, I think, really brings something unique to the marketplace. And so certainly, downward pressure on vaccines, but a very different commercial model there relative to the one that we're considering for CD388.

The next question is for Roy Buchanan with Citizens.

Just a couple of quick ones. I guess, you mentioned the scientific presentations later this year. Have you been accepted at any conferences? And could you tell us what those are? And any key data that we should be looking out for? For example, are you going to have the ADA data from the Phase IIb there?

Yes. Good questions. We have submitted to the ISIRV an IDWeek. And Les, do you want to provide a little color on what -- whether those have been accepted yet? I don't believe they have, but we have high expectations that they will be accepted. Les?

Sure, Jeff. Yes, we have 2 abstracts -- we are submitting 2 abstracts to [ ISIRV ], one to summarize the Phase IIb data and another that has been accepted for an oral presentation, and that's going to be on our activity against a contemporary H5N1 strain, a nonclinical ferret efficacy model, where we demonstrated robust efficacy at [ ISIRV ] in the fall, we will also be presenting -- we've submitted an abstract where we're going to be describing the PK/PD relationships for activity in the Phase IIb trial with CD388.

Okay. Great. And then apologies for the non-CD388 question, keep it quick. But just curious what's next in your view in terms of targets and potential timing when we might see some developments there?

Sure. No specific plans at the moment. Certainly, our oncology program is a great asset, and we have an opportunity to advance that, but we have not determined a specific time frame when we will be advancing that into the clinic.

The next question is from Sarah Nik with H.C. Wainwright.

Just kind of following up on the previous one, I wanted to get a sense of the resolution of the kind of data you'll be presenting at these conferences. You mentioned some PK/PD data. Will you be presenting anything with regards to individual subgroup data at these meetings, maybe with regards to age or region, preventative efficacy outcomes or anything along those lines?

Yes. We will be sharing the details of that when they -- when they are accepted. But certainly, what you mentioned is encompassed in some of the abstracts that have been submitted. Les, any other color you'd like to share on that?

Sara. No, Jeff, you covered it well. Once the abstracts are published, we'll be able to provide more clarity on what will be presented.

This concludes the question-and-answer session. I'd like to turn the conference back over to Dr. Jeff Stein for any closing remarks.

Well, thank you all for joining us today. We greatly appreciate your interest in Cidara and hope you enjoy your evening. Thank you.