Q2 2025 Cidara Therapeutics Inc Earnings Call
Speaker #4: Good afternoon and welcome to the Cidara Therapeutics, Inc. Second Quarter 2025 Earnings Conference Call . All participants will be in listen only mode .
Speaker #4: Should you need assistance during the conference call , you may signal an operator by pressing star , then zero . After today's presentation , there will be an opportunity to ask questions .
Speaker #4: To join the question queue , you can press star followed by one on your telephone keypad . To withdraw your question , please press star then two .
Speaker #4: Please note that the event is being recorded . I would now like to turn the conference over to Brian Ritchie with Lifesci Advisors .
Speaker #4: Please go ahead .
Speaker #5: Thank you . Operator . And good afternoon , everyone . With me today on the from Cidara Therapeutics, Inc. is Doctor Jeff Stein , President and Chief Executive Officer .
Speaker #5: Following Doctor Stein's prepared remarks , he will be joined by Mr. Frank Caba , Chief Financial Officer . Doctor Nicole Dharapani , chief medical officer .
Speaker #5: Doctor Lestari , chief scientific officer . And Mr. Jim Beadle , chief business officer , to participate in a Q&A session earlier this afternoon .
Speaker #5: Sadara released financial results and a phone business update for the second quarter ended June 30th , 2025 . Copy of the press release and the company's corporate presentation are available on its company website .
Speaker #5: 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 #5: We caution listeners that during this call , our 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 .
Speaker #5: These forward looking statements are qualified by the cautionary statements contained in today's press release issued today and the company's SEC filings , including in the Annual Report on Form 10-K and subsequent filings .
Speaker #5: This conference call also contains time sensitive information that is accurate only as of the date of this live broadcast August 7th , 2025 .
Speaker #5: Star undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this conference call .
Speaker #5: With that , I'd like to turn the call over to Doctor Jeff Stein . Jeff .
Speaker #6: Thank you , Brian , and thank you all for joining us for our second quarter 2020 earnings call . We made substantial progress in the second quarter , most notably with the announcement of positive top line results from our phase two B navigate clinical trial .
Speaker #6: Our subsequent $400 million financing and advancing our discussions with the FDA and Barda regarding the further development of CD3 88 . In an effort to keep today's prepared remarks as succinct as possible .
Speaker #6: 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 .
Speaker #6: 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 Sideras proprietary , cloud based platform enables the development of novel drug conjugates , or DFCs , a fundamentally new class of drug that combines the strengths of small molecules with those of monoclonal antibodies .
Speaker #6: Our lead asset , CD3 88 , 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 .
Speaker #6: 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 .
Speaker #6: In late June , we announced the top line results from our Navigate Phase two study , which evaluated the efficacy and safety of a single administration of CD3 88 for the prevention of seasonal influenza in healthy adult subjects .
Speaker #6: The study was initiated the last week of September of last year , and enrollment was completed with over 5000 subjects in the first week of December 2024 , before the peak of the flu season .
Speaker #6: Subjects were randomized across three CD3 , 88 dose groups and one placebo group . The primary analysis included all available data as of April 30th , 2025 .
Speaker #6: The Navigate study was designed initially to determine dose selection for the phase three study , and was not powered for statistical significance prior to study start , we'd expected , based on historical flu season averages , that 2% of participants in the placebo arm would develop influenza illness .
Speaker #6: 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 .
Speaker #6: We discussed and reached agreement with the FDA on modifications to the study's statistical analysis plan to evaluate the potential statistical significance of CD3 88 efficacy versus placebo .
Speaker #6: The observed placebo attack rate and then Navigate study was 2.8% , which enabled the detection of a statistically significant difference from placebo for at each dose group .
Speaker #6: Single doses of 450mg , 300mg , and 150mg of CD3 88 Confer 76 , 61 , and 58% protection , respectively , with p values of less than 0.0001 , 0.0024 and 0.005 .
Speaker #6: At each dose , respectively . This is remarkable given the relatively small size of the study compared to vaccine studies . Importantly , the efficacy data for each of the CD3 88 dose groups exceeded the historical average vaccine effectiveness of approximately 40% for a seasonal vaccine .
Speaker #6: The safety and tolerability data were consistent with prior studies of CD3 88 and similar in all arms of the study , with no safety signals observed .
Speaker #6: While we observed a clear dose response relationship for efficacy . There were no meaningful changes in safety across the dose groups and placebo .
Speaker #6: 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 .
Speaker #6: 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 CD3 88 offer robust , once per season protection against influenza A and B .
Speaker #6: Based on these robust data , we submitted our end of phase two meeting request to the FDA to review the data and discuss the details of a phase three study .
Speaker #6: 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 three to study , including study design , dose selection , and timelines .
Speaker #6: We have guided previously to initiate this study in the Southern Hemisphere . In the spring of 2026 , pending feedback from the FDA .
Speaker #6: 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 two meeting ?
Speaker #6: If we are able to start phase three this fall , we believe that this study will enroll over the course of two flu seasons the 2025 , 2026 Northern Hemisphere and the subsequent 2026 Southern Hemisphere flu season .
Speaker #6: Following the initial flu season , we plan to conduct an interim analysis for potential trial resizing . In phase three , we plan to focus our efforts initially on large populations with the highest unmet need , which includes high risk comorbidities 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 .
Speaker #6: Our plan to address these high unmet need populations is the basis for CD3 eighty-eighths current fast track and priority review designations . In addition , based on the strength of the phase two B 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 .
Speaker #6: 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 CD3 88 .
Speaker #6: We expect to learn the outcome of this submission also by the end of this year , as we prepare to advance CD3 88 into phase three .
Speaker #6: 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 three study .
Speaker #6: This funding also enables us to conduct additional supportive , clinical and non-clinical studies , as well as additional market research to further characterize the cost effectiveness and commercial opportunities for CD3 88 , both in the US and ex-US .
Speaker #6: 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 CD3 88 .
Speaker #6: 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 three plans .
Speaker #6: 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 .
Speaker #6: 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 CD3 88 .
Speaker #6: We look forward to discussing our planned phase three 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 .
Speaker #4: Thank you . We will now begin the question and answer session . To ask a question , you may press star then one on your telephone keypad .
Speaker #4: If you are using a speakerphone , please pick up your handset before pressing any keys . To withdraw your question , please press star then two .
Speaker #4: Our first question is from Seamus Fernandez with Guggenheim Securities . Please go ahead .
Speaker #7: Great . Thanks so much for the question . 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 three design that you shared with us during your Analyst Day .
Speaker #7: 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 three discussion to just clarify those particular points from the type C meeting .
Speaker #7: 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 .
Speaker #7: I don't know if that's something that you can discuss at this point , but I think we've we've have some idea , but it would be interesting to just hear how that exercise is , is advancing and what the prospects might be for Barda .
Speaker #7: The last question that I have is , would that evolve to potentially become something that that could incorporate orders ? It's unclear if the administration is is currently concerned about bird flu or other influenza spreading , but just interested to know what it takes to kind of move forward to to actually get to orders , you know , should the Barda grant be issued ?
Speaker #7: Thanks so much .
Speaker #6: Sure , Seamus , I'll provide some initial responses and then I'll welcome Nicole Tarpana to supplement . So regarding our upcoming meeting with the FDA and regards to your question , you know the difference from the type C meeting .
Speaker #6: We don't have expectation of substantial differences . We largely reached alignment with the FDA and our type C meeting in our discussions regarding the phase three plan .
Speaker #6: The difference is that meeting took place in May before the Navigate phase two B results were available . Now that we have the results , this is the first opportunity to discuss those results within the context of the phase three plan .
Speaker #6: Obviously , based on the strength of the phase three data and the strong safety that we observed . We don't anticipate substantial differences from that discussion regarding Barda .
Speaker #6: The plan , as you are aware , the when you submit these , there is a base period , an option period . We have expectations that the base period will , if funded , would fund manufacturing , in particular the onshoring of manufacturing to the US .
Speaker #6: 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 a emergency use authorization in the event of a bird flu outbreak , we believe that based on the strength of the phase two results , that would be an option should there be an outbreak .
Speaker #6: I would not anticipate a a stocking order for CD3 88 , and in the absence of a emergency use authorization , however . So I'll invite Nicole to provide any additional color on those questions .
Speaker #6: Nicole .
Speaker #8: Thank you Jeff . I think you captured it quite , quite nicely . And hello , Seamus . I think going back to the first point we had , as Jeff mentioned , we had a significant amount of alignment with the FDA on our trial population , the study design and endpoints .
Speaker #8: But of course , that was before the benefit of having this nice phase two 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 .
Speaker #8: And once we have received the meeting minutes , we will share openly the , you know , any changes that have potentially been made .
Speaker #7: Great . Thanks so much .
Speaker #4: The next question is from Eric Schmidt with Cantor Fitzgerald . Please go ahead .
Speaker #6: Thanks for taking my question . Congrats on a just a wonderful second quarter . Maybe just to continue Sheamus's line of discussion around the upcoming FDA meeting .
Speaker #6: 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 timelines are off , but how would you plan to update investors on the outcome from that meeting ?
Speaker #6: 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 ?
Speaker #6: Would seem that CD3 88 might be a good fit for a national priority . Thank you . Sure , Eric . Yeah . All good questions .
Speaker #6: You know , as discussed in the response to Seamus question regarding the FDA meeting , this is the first opportunity really to discuss with them the phase three plan in the context of the phase two B data .
Speaker #6: 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 .
Speaker #6: With respect to your other question , I think you about the CMV voucher , we have submitted a statement of interest to , you know , it's a 350 word statement of interest , and we have yet to receive a response .
Speaker #6: I agree that CD3 88 would appear to be a very good fit . And was there another question , Eric , that I missed ?
Speaker #9: 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 three meeting before having a go decision on this season ?
Speaker #6: Yeah . 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 .
Speaker #6: So we haven't disclosed the details of that because obviously that can change based on the end of phase two meeting . So we will discuss those results when they become available in the form of the meeting minutes from the FDA .
Speaker #6: 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 .
Speaker #6: Nicole , any other color you would like to add to that ?
Speaker #8: Thank you . Jeff . No , nothing further to add .
Speaker #9: Thank you very much . Both .
Speaker #4: The next question is from Brian Abraham with RBC . Please go ahead .
Speaker #10: Hi everyone . Thanks for taking our questions . This is Kevin on for Brian . So just wanted to follow up on a little bit more on the phase three design that you've proposed .
Speaker #10: 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 ?
Speaker #10: And can you explain some of the reasoning behind enrolling the trial over 2 to 3 influenza seasons , instead of just the one season as of the navigate trial ?
Speaker #10: And then could you also remind us on the evidence that you've generated to date that suggests three , eight , eight can be reduced ?
Speaker #10: And then do you imagine that regulators would want to see reducing potential potentially in the pivotal trial ?
Speaker #6: Sure . Yeah . Good questions . Can you repeat the first question please ?
Speaker #10: Yeah . Of course . So , you know , 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 , you know , the needed number of events sooner than the navigate trial had ?
Speaker #6: Yeah . 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 three B , 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 .
Speaker #6: At the same time , they are more protected patient population . And so they go because of the inadequacy of vaccines and protecting these patients , they are highly protected .
Speaker #6: They 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 .
Speaker #6: In regard to your other question on dosing , yes , we do anticipate conducting a dosing study that is planned and is basically a continuation of reducing that we had conducted in our first phase one study where we are looking for antidrug antibodies .
Speaker #6: We didn't see any substantial evidence of that . We also looked for those in the phase two study . But we have this great resource in the subjects we enrolled in the Navigate phase two study that have received a dose , three different doses of CD3 88 .
Speaker #6: So we're going to take advantage of that resource and take a subset of those subjects for a dosing study that we anticipate starting shortly .
Speaker #10: Okay . Thank you so much . And then what do you think the timelines for that would be . Would that be kind of prior to the initiation of the the pivotal trial or or just .
Speaker #6: Yeah we will . Yeah we will . Yeah . Good . Good question . We'll communicate that after we receive the meeting minutes from our upcoming end of phase two meeting , because we'll be discussing that with the FDA .
Speaker #10: Okay . Great . Thank you so much .
Speaker #6: Sure .
Speaker #4: Next question is from Joseph Stringer with Needham and Company . Please go ahead .
Speaker #11: Good afternoon . This is Eddie on for Joey . Thanks for taking our questions . Just two from us . First , just kind of to follow up on the previous question , I'm wondering what assumptions are built into that cash runway .
Speaker #11: And does this include that dosing trial as well as the potential for a second phase three trial and then a follow up ? Just looking at the the landscape fantasy guided for Mid-teen percent declines in their food business this year , partly due to the US pricing pressures .
Speaker #11: I'm curious what what might be possible for your business and maybe some commercial outlook for CD3 88 ?
Speaker #6: Sure . For the first question on Cash Runway , let me turn that one over to Frank cava , our CFO . Frank .
Speaker #6: Yeah , sure .
Speaker #7: Hey , Eddie .
Speaker #12: So , look , with the 500 plus million dollars in cash on hand now , we believe we are adequately funded through the end of our phase three program , including the additional studies that we have cited here on this call , and also including different potential scenarios , how the phase three could play out .
Speaker #6: And then with respect to the second question , if you could repeat that , I know it was a commercial question regarding a Sanofi product , and I will turn that over to Jim Beedle , our chief business Officer .
Speaker #6: So if you could repeat that question first .
Speaker #11: Yeah , absolutely . Just on Sanofi's earnings call , they guided for a mid-teen percent declines this year in their flu business . And just seeing if there's any read through to your business or commercial outlook for CD3 88 .
Speaker #6: Yeah . Jim . Yeah , thanks for the question . Certainly . Yeah , I appreciate the question . And certainly there's .
Speaker #13: 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 Cd38 .
Speaker #13: 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 their the burden of illness is highest .
Speaker #13: And the value proposition that we've demonstrated in the navigate study and intend to demonstrate in the phase three , I think really brings something unique to the marketplace .
Speaker #13: And so certainly downward pressure on vaccines , but a very different commercial model there relative to the one that we're considering for Cd38 .
Speaker #11: Okay . Thanks so much .
Speaker #4: The next question is for Roy Buchanan with citizens . Please go ahead .
Speaker #14: Hey , great . Thanks for taking the question . Just a couple quick ones I got . You mentioned the scientific presentations later this year .
Speaker #14: Have you been accepted at any conferences , and could you tell us what the what those are and any key data that we should be looking out for ?
Speaker #14: For example, are you going to have the Ada data from Phase Two be there?
Speaker #6: Yeah . Good questions . We have submitted to the Eserve and Idweek and less . Do you want to provide a little color on what whether those have been accepted yet ?
Speaker #6: I don't believe they have. But we have high expectations that they will be accepted less.
Speaker #9: Sure .
Speaker #6: Jeff and hi Roy . Yeah , we have two abstracts that we are submitting , two abstracts . I deserve one to summarize the phase two data and another that has been accepted for .
Speaker #6: a oral presentation . And that's going .
Speaker #13: To be on our . activity against a contemporary H5n1 strain , a non-clinical ferret efficacy model where we demonstrated robust efficacy at at as we in the fall , we will also be presenting , we've submitted an abstract to where we're going to be describing the PK relationships for activity in the phase two trial with CD3 88 .
Speaker #14: Okay , great . And then apologies for the non cd38 question . Keep it quick . But I'm just curious what's next in your view in terms of targets and potential timing when we might see some developments there .
Speaker #14: Thanks .
Speaker #6: Sure . Yeah . No specific plans at the moment . Certainly our oncology program is is a great asset and we have an opportunity to advance that .
Speaker #6: But we have not determined a specific time frame when we will be advancing that into the clinic .
Speaker #14: Okay . Perfect . Thank you .
Speaker #4: Once again , if you have a question , please press star then one . The next question is from Sarah Nick with H.C. Wainwright .
Speaker #4: Please go ahead .
Speaker #15: Hi , and thanks for taking the question . 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 .
Speaker #15: 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 ?
Speaker #15: Thank you .
Speaker #6: Yeah , we'll be we will be sharing the details of that when they be when they're accepted . But certainly what you mentioned is encompassed in some of the abstracts that have been submitted less .
Speaker #6: Any other color you'd like to share on that?
Speaker #11: One ?
Speaker #13: Hi , Sarah . No , Jeff , you you covered it . Well , once the abstracts are published , we'll be able to provide more clarity on what will be presented .
Speaker #15: All right. Great. Thank you.
Speaker #4: This concludes the answer session . I'd like to turn the conference back over to Doctor Jeff Stein for any closing remarks .
Speaker #6: Well, thank you all for joining us today. We greatly appreciate your interest in Sidera and hope you enjoy your evening. Thank you.