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.

Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press the star followed by the number 1 on your touchtone phone. you will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press the star followed by the number two. If you are using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Also, please limit your questions to one question and one follow-up. Your first question is from Eric Schmidt from Kantor. Please go ahead.

Thanks for taking my question, honored to be the inaugural question on your inaugural earnings conference call. Jeff, it was a little unclear to me from your statements whether you've had your discussions with the FDA regarding the statistical for the Phase 2B or whether those discussions are still ongoing. Yes, Eric, we have had those discussions, and we look forward to sharing the statistical analysis plan update at our May 22nd R&D Day event. Thanks for that update. And maybe as a follow-up, if you had time to better fine-tune or hone in on your definition of what a high-risk patient population might actually mean or be defined by in terms of demographics in Phase III. Yeah, we also plan to share that at the R&D Day event. So we are finalizing the assessment of those populations, and we're really looking forward to highlighting that in the commercial section of R&D Day. Great. I'll try and be patient then. Thank you. Okay. Thank you.

Your next question is from Seamus Fernandez from Ugenime. Please go ahead.

Great. Thanks for the question, and Jeff, congratulations on keeping your presentation almost as brief as the open harbor statement. So I'll just go with a quick question here. You know, I think to Eric's question around the size of the patient population, I know you guys are going to address a little bit more in the context of the R&D day in terms of the size of the potential patient population to consider here, but historically, I think you've talked about 20 million patients. Just wondering if you see a broader opportunity than that. And then just my follow-up question to that is, in terms of a pricing dynamic historically, we've modeled something in the range of $180 to $200. But I think in other conversations that we've had, a range potentially broader than that. has been discussed. So just love to get a little bit more color for those participating in the call to give a little bit of a preview for the R&D Day. Thanks.

Yeah, sure, Seamus. And I'll give you a few remarks, then I'll turn it over to Jim Beidle to refine those remarks. And again, we will share more details at the R&D Day event. But, yes, our thinking has evolved since we last spoke about this, and we see a substantial opportunity in that high-risk comorbid as well as the immune-compromised populations. And so let me turn it over to Jim, and I'll let him give you an update on some of those broad parameters with the aim of providing more details on both the size of the population as well as pricing. Jim?

Yeah, certainly, Jeff. Thanks for the question, Seamus, and it's certainly a good one. We've been thinking more deeply about the patient segmentation quite a bit these days, and the 20 million number refers to people with very severe forms of COPD, heart disease, renal disease, and more severe forms of immune-compromised status. We definitely see upside beyond that. It's very clear in our market research that physicians have broader interest in the product, And so, you know, we are interested in people with moderate forms of these conditions, and I think you'll see some of that segmentation data in our current corporate deck that's available on the website. And we'll get into it in more detail on the 22nd, along with the market research findings from our physician and payer interviews. I think you also asked a question about price, and we'll also get into this in more detail on the 22nd. But we certainly see opportunity for pricing meaningfully above the number that you mentioned there. You know, this is not a vaccine, and it's also a product that has the potential by focusing on these higher risk comorbidities to bring substantial value. And we're seeing that sort of be reflected in the market research we're doing. So excited to get into that more on the 22nd, but very confident in price points above the number that you mentioned there.

Thanks so much. Appreciate it.

Your next question is from Gregory Renza from RBC Capital Markets. Please go ahead.

Greg, good afternoon, Jeff and team. Congrats on the progress so far. We're all looking forward to the updates in the next couple of months, and thanks for taking my questions. Jeff, maybe I'll just start with just a broader one. Just with respect to your positioning of CD388, amidst a great deal of dialogue amongst the community, both publicly and amongst regulatory bodies, about vaccines and evolving views on that, how should we think about CD388 and that positioning? Of course, your mention of the single seasonal dose prophylaxis amidst the broad but also high-risk populations, as well as potential complementarity with vaccines. Curious on your broader thoughts there.

Yeah, great questions. We do aim to initially develop CD3 in that high-risk population. So definite focus are in those populations that are underserved by vaccines. And even in healthy normal individuals, roughly about 40% of people get vaccinated, and of those, it's about 40% effective. So certainly there's an opportunity to expand beyond that high-risk population, and that has definitely captured our attention, and that's a plan for future development. We're also in discussions with BARDA for the opportunity to collaborate with BARDA given CD380's potential for the prevention of H5N1. So we see a number of opportunities in both high-risk as well as in broader populations that CD3 can definitely benefit. And Jim, anything else you'd like to add to Greg's question?

No, Jeff, I think you said it very well. I feel really confident that physicians are recognizing that vaccines are not adequately protecting these individuals. And if they were, I think we'd see something different in the hospitalization rate data. So unmet need despite vaccination is clearly there. And actually, we'll have some data on this on the 22nd where we ask physicians, you know, the specialists in particular, those that manage these high-risk patients, their perception of the importance of flu and preventing flu in these patients. And it's very strong data, and I'll be excited to share that with you on the 22nd.

And Greg, just to get to the last part of your question, we do aim to develop CD388 in conjunction with existing vaccines. I think you may have been referring to the fact that CD388 in general targets a different target than vaccines. So vaccines target hemagglutinin and CD388 targets neuraminidase. We see that there is a potential that there could be some complementarity on top of vaccines. We haven't demonstrated that yet, but we hope to be able to do that in the clinic.

That's great. I really appreciate that. Maybe just as my follow-up, and we can brace ourselves for the details, I just wanted to ask you to potentially just frame up the the primary endpoint for Navigate and just that the composite and the mechanics of the data collection around PCR and, of course, the symptom collection and the e-visits, any additional color you could add about how that comes about would be greatly appreciated. Lots of investment.

Absolutely. And Nicole's in the best position to address that question on how we evaluate the primary endpoint in the Navigate study. Nicole?

Hi, Greg. Thanks for the question. So our primary endpoint is preventive efficacy, and that is evaluated by centrally confirmed influenza infection, which has three key components. So the first one would be nasopharyngeal PCR positivity. And so when subjects come in with symptoms, they are evaluated for a local mid-turbinate swab as well as a nasopharyngeal swab, which is a little bit more of an invasive swab, and that is sent to a central lab for confirmation. That is the first piece. In addition, there are requirements for a body temperature of 38 degrees, as well as two symptoms, two respiratory or one respiratory and one systemic. So as you can see, it's a robust evaluation to really confirm symptomatic and severe flu.

Thanks, Edward.

I really appreciate the color. Congrats again. Your next question is from Joseph Stringer.

from Needham Company. Please go ahead.

Hi. Thanks for taking our questions. Just on the Phase 2b readout for the three dose levels, you're anticipating that we would see a dose-dependent response on efficacy, and I suppose has that view changed given the higher than expected breakthrough infection rates here? And maybe lastly, how important is it that a dose, seeing a dose response from a data confidence standpoint and potential next steps?

Yeah, that's an important question, Joey. And keep in mind that the subjects were enrolled from the last week of September to the first week of December. And so there's going to be a gradation of exposures over time. And so, yes, we do expect to see a dose dependence, but probably more succinctly, We expect to see an exposure dependence because one can envision that subjects randomized in the high-dose group dose first, end of September, might have lower exposure towards the end of the study than subjects dose last in the study at the lower dose. So, yes, we do expect to see a dose dependence because it is randomized. However, it's more important that we actually look at the relationship between exposure and efficacy, and we hope to be able to talk about that when we disclose top line data as well.

Great. That's very helpful. Thanks for taking our questions.

Ladies and gentlemen, as a reminder, should you have any questions, please press the star key followed by the number one. The next question is from Roy Boothman from Citizens Bank. Please go ahead.

Hey, thanks for taking the questions. Just, I guess, to follow up on the last one, are you going to be able to present any, I guess, time course data, Kaplan-Meier curve kind of data for each of the doses? Are we going to be able to see when patients actually had an event going through the trial? Thanks.

I'm not sure we will have that high resolution of information in the top line results, but let me turn that to Nicole to see if she's more familiar with the level of detail that we'll have in those top line tables, listings, and figures.

Yes. Hi. Thanks for the question. We are expecting to have essentially kind of prevention efficacy data as numerical tables at this time, the reason being that we do want to continue to follow the PK data that comes in throughout the trial. And as you know, this is not a time to event analysis. It's a when kind of subjects develop flu at binary. So we don't expect to have Kaplan-Meier differentiation.

Okay, got it. I guess as a follow-up to that, and I have a follow-up, but when do you think we might see that PK data?

We expect the PK data at the end of the trial. So that would be approximately September analysis. We are certainly going to try to obtain it, however. And so we may be able to see some of that data. But because we had essentially had an April 30th data cut, there will be further PK data that comes in that might be substantially important. And so if it's not definitive, we plan to wait until that September deadline. Okay, great.

Yeah, as a follow-up to that, Roy, you know, as you know, the CD388, it does have a long half-life of six to eight weeks. And for safety, we will follow, we will be following subjects out for five half-lives. And so the final data we expect in September now, you know, we don't expect to have any substantial number of new flu infections occurring after April 30th. Yeah. it's not for efficacy, but it's more for PK and safety.

Yeah, yeah, the season's pretty much done, right? So, and then, sorry, let me ask one more, because I suspect on the last question, and kind of along the same lines, you know, if I'm counting right, it looks like the data cutoff is about three weeks before the, you know, 24-week potential limit. I mean, was that really based on the flu season rates or the rates observed in the study? Thanks.

It was based on the diminishing returns. So the CDC definition for the flu season coincides with April 30th. We saw a decrease in the pace of infections appearing in the study that coincided with that date.

There are no further questions at this time. I will turn the call over to Jeff Stein for closing remarks.

Well, thank you all for joining us today. We greatly appreciate your interest in CIDERA and hope that you can join us for R&D Day on May 22nd. Enjoy your evening.

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.