Cidara Therapeutics - Earnings Call - Q1 2025

Executive Summary

• Q1 2025 was a non-revenue quarter with collaboration revenue $0.00 versus $0.97M in Q1 2024; diluted EPS was -$1.66, materially better than Wall Street consensus of -$3.57, driven in part by a $5.51M reversal of indirect tax liabilities and higher interest income; revenue was in line with a $0.00 consensus.*
• R&D increased to $24.6M (vs. $5.9M YoY) as CD388 Phase 2b NAVIGATE trial costs ramped; G&A rose to $6.2M (vs. $3.6M YoY); net loss was $23.5M vs. $10.3M YoY.
• Management set April 30 as NAVIGATE’s efficacy data cutoff and anticipates top-line in late June; discussions with FDA on statistical analysis plan could enable dose selection and statistical significance assessments by dose versus placebo.
• Catalysts: May 22 R&D Day, late-June NAVIGATE top-line readout, and potential Phase 3 initiation in Spring 2026 (Southern Hemisphere); BARDA engagement noted for H5N1 preparedness.

What Went Well and What Went Wrong

What Went Well

• “We have established April 30, 2025 as the data cutoff… We are expecting top-line results in late June… [and] opportunity to discuss changes to the study’s statistical analysis plan with the U.S. FDA”.
• Strong cash runway: cash, cash equivalents and restricted cash of $174.5M at March 31, 2025, following $105M financing in Nov-2024 and $240M raised in Apr-2024 to fund NAVIGATE.
• CD388 scientific validation momentum: Nature Microbiology publication and multiple scientific presentations highlighting broad, universal antiviral potential and favorable safety in Phase 1/2a studies.

What Went Wrong

• Revenue headwind: collaboration revenue fell to $0.00 (vs. $0.97M YoY) post-termination of the Janssen collaboration agreement in Apr-2024; revenue base remains de minimis.
• Opex escalation: R&D rose to $24.6M and G&A to $6.2M YoY driven by NAVIGATE costs and personnel; while helped by a $5.51M indirect tax liability reversal, underlying burn rate remains elevated.
• Net loss widened YoY to $23.5M vs. $10.3M, reflecting the transition to a single lead asset program without collaboration revenue offsets.

Transcript

Operator (participant)

Greetings. Welcome to Cidara Therapeutics' 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.

Brian Ritchie (Managing Director)

Thank you, Operator, and good afternoon, everyone. With me today on the phone from Cidara Therapeutics are 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 first quarter ended March 31, 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, 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 included 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 8th, 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?

Jeff Stein (President and,CEO)

Thanks, Brian. 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 Cidara'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 approved antiviral small molecule drug, zanamivir, 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 CD388'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, Cidara presented data at the 34th ESCMID conference from our phase I 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. We also presented data at this conference from our phase II A human challenge study of CD388 in 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 II B study. This 150 milligram dose is the lowest of three doses tested in our phase II B study. Our Navigate phase II B 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 we expect to announce top-line data by the end of June.

The Navigate study was initially designed primarily to determine dose selection for phase III and 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 II B 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 III 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 II B Navigate trial, updates on our regulatory discussions, and our plans for a phase III 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 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 critical need for a durable, broadly acting antiviral like CD388. We look forward to the results of our phase II B clinical trial, continued discussions with the FDA, and the potential initiation of our planned phase III study.

With that, I will turn it back to the Operator to take your questions.

Operator (participant)

Thank you. Ladies and gentlemen, we'll now begin the question and answer session. Should you have a question, please press the star followed by the number one on your touch-tone 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 Cantor Fitzgerald. Please go ahead.

Eric Schmidt (Biotechnology Analyst)

Oh, 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 II B or whether those discussions are still ongoing.

Jeff Stein (President and,CEO)

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.

Eric Schmidt (Biotechnology Analyst)

Thanks for that update. 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 the phase III.

Jeff Stein (President and,CEO)

Yeah, we also plan to share that at the R&D day event. 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.

Eric Schmidt (Biotechnology Analyst)

Great. I'll try and be patient then. Thank you.

Jeff Stein (President and,CEO)

Okay. Thank you.

Operator (participant)

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

Seamus Fernandez (Senior Managing Director)

Great. Thanks for the question. Jeff, congratulations on keeping your presentation almost as brief as the open harbor statement. I'll just go with a quick question here. 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. Historically, I think you've talked about 20 million patients. Just wondering if you see a broader opportunity than that. My follow-up question to that is, in terms of a pricing dynamic, historically, we've modeled something in the range of $180-$200, but I think in other conversations that we've had, a range potentially broader than that has been discussed.

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.

Jeff Stein (President and,CEO)

Yeah. Sure, Seamus. I'll give you a few remarks, then I'll turn it over to Jim Beitel to refine those remarks. Again, we will share more details at the R&D day event. 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. 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 Beitel (Chief Business Officer)

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. 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. 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. 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 the question about price, and we'll also get into this in more detail on the 22nd. We certainly see opportunity for pricing meaningfully above the number that you mentioned there. 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. We're seeing that sort of be reflected in the market research we're doing. Excited to get into that more on the 22nd, but very confident in price points above the number that you mentioned there.

Seamus Fernandez (Senior Managing Director)

Thanks so much. Appreciate it.

Operator (participant)

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

Gregory Renza (Senior Biotechnology Analyst)

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, 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, it's 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.

Jeff Stein (President and,CEO)

Yeah, great questions. We do aim to initially develop CD388 in that high-risk population. Definite focus are in those populations that are underserved by vaccines. Even in healthy normal individuals, roughly about 40% of people get vaccinated, and of those, it's about 40% effective. 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 CD388's potential for the prevention of H5N1. We see a number of opportunities in both high-risk as well as in broader populations that CD388 can definitely benefit. Jim, anything else you'd like to add to Greg's question?

Jim Beitel (Chief Business Officer)

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. If they were, I think we'd see something different in the hospitalization rate data. Unmet need despite vaccination is clearly there. Actually, we'll have some data on this on the 22nd where we ask physicians, the specialists in particular, those that manage these high-risk patients, their perception of the importance of flu and preventing flu in these patients. It is very strong data, and I'll be excited to share that with you on the 22nd.

Jeff Stein (President and,CEO)

Greg, you just did 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. 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.

Gregory Renza (Senior Biotechnology Analyst)

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

Jeff Stein (President and,CEO)

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

Nicole Davarpanah (CMO)

Hi, Greg. Thanks for the question. 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 nasopharyngeal PCR positivity. 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 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. As you can see, it's a robust evaluation to really confirm symptomatic and severe flu.

Gregory Renza (Senior Biotechnology Analyst)

Thanks, everyone. Really appreciate the color. Congrats again.

Operator (participant)

Your next question is from Joseph Stringer from Needham & Company. Please go ahead.

Joseph Stringer (Managing Director)

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

Jeff Stein (President and,CEO)

Yeah, that's an important question, Jo. Keep in mind that the subjects were enrolled from the last week of September to the first week of December. There's going to be a gradation of exposures over time. 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 dosed first in the end of September might have lower exposure towards the end of the study than subjects dosed last in the study at the lower dose. 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. We hope to be able to talk about that when we disclose top-line data as well.

Joseph Stringer (Managing Director)

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

Operator (participant)

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 Boothenin from Citizens Bank. Please go ahead.

Roy Buchanan (Equity Research Analyst)

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.

Jeff Stein (President and,CEO)

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.

Nicole Davarpanah (CMO)

Yep. 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. As you know, this is not a time-to-event analysis. It is a when kind of subjects develop flu binary. We do not expect to have Kaplan-Meier differentiation.

Roy Buchanan (Equity Research Analyst)

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?

Nicole Davarpanah (CMO)

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

Roy Buchanan (Equity Research Analyst)

Okay. Great. Yeah.

Jeff Stein (President and,CEO)

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

Roy Buchanan (Equity Research Analyst)

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

Jeff Stein (President and,CEO)

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

Operator (participant)

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

Jeff Stein (President and,CEO)

Thank you all for joining us today. We greatly appreciate your interest in Cidara and hope that you can join us for our R&D day on May 22nd. Enjoy your evening.

Operator (participant)

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