Q1 2025 Cidara Therapeutics Inc Earnings Call

Greetings and welcome to <unk> Q1, 2025 earnings call.

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Following the presentation, we will conduct a question and answer session.

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Speaker Change: I will now turn the conference over to Brian Ritchie of lifestyle advisors. Thank you you may begin.

Brian Ritchie: Thank you operator, and good afternoon, everyone.

Speaker Change: With me today on the phone from Siddharth Therapeutics.

Jeff Stein: Doctor, Jeff Stein, President and Chief Executive Officer.

Speaker Change: Wallowing Doctor signs prepared remarks, he will be joined by Mr. Frank Hobby.

Speaker Change: Financial Officer, Dr. Nicole Dogger Palmer.

Speaker Change: Medical Officer.

Speaker Change: Doctor Lestari.

Speaker Change: So I kept saying typical officer and me.

Jim: Mr. Jim vital.

Speaker Change: If business officer to participate in a Q&A session.

Speaker Change: Earlier this afternoon.

Speaker Change: So Dara released financial results and a business update for the first quarter ended March 31st 2025.

Speaker Change: A copy of the press release.

Speaker Change: <unk> 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.

Speaker Change: We caution listeners that during this call the dark matter, but we'll be making forward looking statements.

Speaker Change: Actual results could differ materially from those stated.

Speaker Change: Or implied by these forward looking statements due to risks and uncertainties associated with the company's business.

Speaker Change: These forward looking statements are qualified by the cautionary statements contained in <unk> press release issued today.

Speaker Change: Today, the company's SEC filings included in the annual report on form 10K and subsequent

Speaker Change: This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast.

May 8th, 2025.

Speaker Change: Cidara undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this conference call.

Speaker Change: With that, I'd like to turn the call over to Jeff Stein. Jeff?

Jeff Stein: Thanks, Brian , and thank you all for joining us for a first quarter 2025 earnings call. Please note, given our upcoming virtual R&D day on the 22nd, I'll keep my remarks brief today with the idea of sharing significantly more details around our ongoing CD38 clinical program at that event.

Jeff Stein: 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 in our 10Q which we are filed today.

Jeff Stein: With that, and since this is our inaugural quarterly earnings call, let me begin by reminding everyone that Cidara's proprietary cloud-break platform enables the development of novel drug F.C. conjugus.

Jeff Stein: or DFCs, a fundamentally new class of drug that combines the strengths of small molecules with that of monoclonal antibodies.

Jeff Stein: Our lead asset, CD-388, we aim to revolutionize the prevention of influenza, which, despite vaccines, has a mortality rate in the US that is similar to breast cancer, colorectal cancer, and all blood cancers.

Jeff Stein: CD388 combines a novel, multivariant presentation of the accrued, antiviral, small molecule drug, synamorphure.

with a human antibody fragment to prolong half-life.

Jeff Stein: 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.

Jeff Stein: It's unique properties substantially enhance its antiviral activity, making it a potentially best-in-class neuro-minidase inhibitor that overcome the limitations of existing vaccines and antivirals.

Jeff Stein: Details of CD380's preclinical data were recently published in the journal Nature Microbiology.

Jeff Stein: 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.

Jeff Stein: This included activity against high pathogenicity strains like H5N1, also known as bird flu as well as strains that are resistant to approved neuro-minidase inhibitors.

Jeff Stein: In April of last year Cidara presented data at the 34th Estimate Conference from our phase one single ascending dose study of CD388, which showed it to be well tolerated and with an extended half-life supporting the potential of once per flu season dosing.

Jeff Stein: We also presented data at this conference from our phase 2A Human Challenge Study of CD-3-88 in Healthy Volunteers.

Jeff Stein: The results showed that a single 150 milligrams subcutaneous dose of CD-388 provided substantial protective efficacy compared to placebo and supported the advancement of CD-388 to a phase to B-studying.

Jeff Stein: This 150 milligram dose is the lowest of three doses tested in our phase 2B study.

Jeff Stein: Our Navigate Phase 2B study evaluating the efficacy and safety of a single administration of CD-388 for the prevention of seasonal influenza in healthy and adult subjects was initiated the last week of September of last year.

Jeff Stein: Dosing of 5,041 subjects was completed in the first week of December . Subjects were randomized across three CV-388 dose groups, 150 milligrams, 300 milligrams, or 450 milligrams, and one placebo group.

Jeff Stein: The primary analysis will include all available data as of April 30th, 2025, and we expect to announce top-line data by the end of June .

Jeff Stein: The Navigate Study was initially designed primarily to determine dose selection for phase 3, and was not powered for statistical significance.

Jeff Stein: 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 CD-388 versus placebo.

Jeff Stein: Dependent on the results of our Phase 2B study and our regulatory discussions. We expect to initiate a Phase 3 study in the spring of 2026 in the Southern Hemisphere.

Jeff Stein: We plan to conduct our phase 3 study in high risk co-morbid and immune compromised patients.

Jeff Stein: 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.

Jeff Stein: On May 22nd, we plan to host an R&D Day. The event will focus on a review of the 2024-2025 Flitter season.

Jeff Stein: Updates on our ongoing phase 2V 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 CD-388.

Jeff Stein: In closing, the data we have generated to date further validate our cloud-break DFC platform.

Jeff Stein: and the potential of CD3, ADA to offer universal protection against both seasonal and pandemic influenza strains.

Jeff Stein: 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 CD388.

Jeff Stein: We look forward to the results of our phase 2D clinical trial, continued discussions with the FDA, and the potential initiation of our planned phase 3 study.

Thank you.

Speaker Change: Ladies and gentlemen, we will now begin the question and answer session.

Jeff Stein: Should you have a question, please press the star followed by the number one on your touch on phone.

Jeff Stein: You will hear a prompt that your hat has been raised.

Jeff Stein: Should you wish to decline from the pull-in process, please press the star followed by the number two.

Jeff Stein: If you are using a speaker phone, please lift the headset before pressing any keys.

One moment please, for your first question.

Speaker Change: Also, please comment your questions to one question and one follow-up. Your first question is from Eric Schmidt, from Cantor. Please go ahead.

Eric Schmidt: Oh, thanks for taking my question honor to be the inaugural question on your, an out-of-the-world earnings conference call. It was a little unclear to me from your statements whether you've had your discussions with the FDA regarding

Speaker Change: For the phase 2b, or one of those discussions, are still on guard.

Speaker Change: 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.

Speaker Change: Thanks for that update and maybe we'll follow up again. I 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 from the phase three.

Speaker Change: 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.

Speaker Change: Great, I'll try to be patient then. Thank you. Okay, thank you.

Speaker Change: Your next question is from Sheamus Fernandez from Guggenheim. Please go ahead.

Great. Thanks for the question, and Jeff, congratulations on...

Speaker Change: Keeping your presentation almost as brief as the open harbor statement.

Speaker Change: 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.

Speaker Change: of the potential patient population to consider here, but historically that 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.

Speaker Change: 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.

Speaker Change: has been discussed. So just love to get a little bit more color, you know, for those participating in the call, to give a little bit of a preview for the R&D day. Thank you.

Speaker Change: I'll give you a few remarks, then I'll turn it over to Jim Bidle to refine those remarks. And again, we will share more details at the R&D data event. But yes, our thinking has evolved since we last spoke about this.

Speaker Change: And we see a substantial opportunity in that high-risk comorbid as well as the immune-capamized populations.

Jim Vital: 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.

Jim Vital: Yes, certainly Jeff. Thanks for the question, Shamis, and it's certainly good when we've been taking more deeply about the patient segmentation quite a bit these days.

And a 20 million number refers to people with very severe forms of COPD heart disease.

Jim Vital: Renal disease and, you know, more severe forms of immune compromise status. We definitely see outside the on that is very clear in a market research that physicians have broader interest in the product.

Jim Vital: 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 in the 22nd along with the market research findings from our physician and parry interviews.

Jim Vital: I think you also asked a question about price and we'll also get into this in more detail on the 22nd.

Jim Vital: 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.

Jim Vital: 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.

Speaker Change: Your next question is from Gregory Renta from RBC Capital Markets. Please go ahead.

Gregory Rinza: Great. 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.

Thanks for taking my questions.

Speaker Change: Vaccines and evolving views on that. How should we think about CD-388 in that positioning? Of course, your mention of the single seasonal dose, prophylaxis admits.

Gregory Rinza: and the broadband also high-risk populations, as well as potential complementarity with effects.

Curious on your broader thoughts there.

Speaker Change: Yeah, great, great questions. We do aim to initially develop CD3, it did in that high-risk population, so...

Speaker Change: Definite focus are in those populations that are underserved to violent vaccines and even in healthy normal individuals.

Speaker Change: Roughly about 40% of people get vaccinated and of those it's about 40% effective.

Speaker Change: 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.

Speaker Change: We are also in discussions with BARDA for the opportunity to collaborate with BARDA given CD-380s potential for the prevention of H5N1.

Speaker Change: So we see a number of opportunities in both high risk as well as in broader populations that the CD-3D can definitely benefit.

Jim Vital: And Jim, anything else you'd like to add to Greg's question?

Speaker Change: 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.

Speaker Change: So, unmet need despite vaccination is clearly there. And actually, we'll have some data on this in the 22nd, where we ask physicians, you know, the specialists, in particular, those that manage these high risk patients.

Speaker Change: The 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.

Speaker Change: In grade three of you just to get to the last part of your question.

Speaker Change: We do aim to develop CD388 in conjunction with existing vaccines.

I think you may have been referring to the...

Speaker Change: The fact that CD-388 in general targets a different target than vaccines. So, vaccines target hemoglobin and CD-388 targets neurometadase. 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.

Speaker Change: Best positioned to address that question on how we evaluate the primary endpoint navigates that call.

Speaker Change: Hi, great. Thanks for the question and so our primary endpoint is preventive efficacy and that is evaluated by centrally confirmed influenza infection, which has three key components. The first one would be nasal pharyngeal PCR positivity and so when subjects come in with symptoms. They are evaluated upfront load.

Speaker Change: Nick.

Speaker Change: Turbine at swap as well as in nasal pharyngeal swab with just a little bit more invasive swaps 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.

Speaker Change: Well as to symptoms to respiratory.

Speaker Change: Respiratory or one respiratory and one stomach. So as you can see it's a robust evaluation to really confirm symptomatic and sit here flu.

Speaker Change: Okay.

Speaker Change: Thanks, everyone really appreciate the color congrats again.

Speaker Change: Your next question is from Joseph Stringer from Needham <unk> Company. Please go ahead.

Speaker Change: Hi, Thanks for taking our questions just on the phase <unk> readout for the three dose levels.

Speaker Change: It is fitting that we would see a dose dependent response and efficacy and I suppose is that may change given the higher than expected breakthrough infection rates.

Speaker Change: Sure.

Speaker Change: And maybe lastly, how important is it that.

Speaker Change: Dose seeing a dose response from a confidence standpoint and potential next steps.

Speaker Change: Yes, that's an important question joy and keep in mind that these subjects were enrolled from the last week of September to the first week of December.

Speaker Change: So there's going to be a gradation of exposures over time.

Speaker Change: So yes, we do expect to see a dose dependent but probably more succinctly, we expect to see an exposure dependence because one could envision that.

Speaker Change: Subjects randomized and the high dose group dose first in.

Speaker Change: End of September might have lower exposure towards the end of the study then subjects dosed last in this study at a lower dose. So yes, we do expect to see a dose dependent because it is randomized.

Speaker Change: 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 at our when we disclose top line data as well.

Speaker Change: Okay, Great. That's very helpful. Thanks for taking our questions.

Speaker Change: Okay.

Speaker Change: Ladies and gentlemen, as a reminder, should you have any questions. Please press the starkey followed by the number one.

Speaker Change: The next question is from Roy Buchanan from citizens Bank. Please go ahead.

Roy Buchanan: Hey, Thanks for taking the questions just I guess a follow up on the last one.

Speaker Change: Are you going to be able to present any I guess time course data Kaplan Meier curve kind of data.

Speaker Change: For each of the doses that we're going to be able to see when patients actually had an event going through the trial.

Speaker Change: 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 is more familiar with the level of detail that will have some that was topline tables listings and figures.

Nicole: Hi, Thanks for the question, we are expecting to have essentially kind of.

Nicole: Prevention efficacy data.

Nicole: But people at this time the reason being that we do want to continue to follow.

Nicole: That would take out of that comes in throughout the trial.

Nicole: And as you know this is not a time to event analysis.

Nicole: When developed through a binary.

Nicole: Don't expect to have Kaplan Meier differentiation.

Nicole: Okay got it.

Nicole: And I guess.

Nicole: As a follow up to that and I have a follow up on that.

Nicole: When do you think we might see that PK data.

Nicole: We expect the PK data at the end of the trial.

Nicole: So that would be.

Nicole: And at least at September analysis.

Nicole: We are certainly going to try to obtain it however, and so we'd be we may be able to see some some of that data.

Nicole: We had.

Nicole: I actually had an April 30th data cut that will be further PK data that comes in that might be substantially important until it that's not definitive we plan to wait until that September I got.

Nicole: Okay.

Nicole: Yes, yes.

Roy Buchanan: So as a follow up to that Roy as you know the city 388. It does have a long half life of six to eight weeks and for safety. We will follow we will be following subjects out four five half lives and.

Roy Buchanan: So the final data we expect in September now, we don't expect to have any substantial number of new flu infections occurring after April 30th.

Roy Buchanan: Okay.

Roy Buchanan: It's not for efficacy, but it's more for PK and safety.

Roy Buchanan: Yeah, Yeah, well, even if it's down right. So.

Speaker Change: And then sorry, let me ask one more because I suspect on the last question.

Roy Buchanan: And kind of along the same lines.

Roy Buchanan: If I'm counting right it looks like the data cutoff is about three weeks before the 24 week potential limit I mean, what is that really based on the flu season rates are the rates observed in that study. Thanks.

Speaker Change: It was based on the.

Speaker Change: Diminishing returns right. So the CDC definition for the flu season as it coincides with the April 30th.

Speaker Change: Saw a decrease in the pace of infections are appearing in the study.

Speaker Change: That coincide with that data.

Speaker Change: There are no further questions at this time.

Speaker Change: I'll turn the call over to Jeff Stein for closing remarks.

Speaker Change: Well. Thank you all for joining US today, we greatly appreciate your interest in <unk> and hope that you can join us for our R&D day on May 22nd enjoy your evening.

Speaker Change: Ladies and gentlemen, this concludes your conference call for today, we thank you for participating and ask that you. Please disconnect your lines.