Cidara Therapeutics, Inc.

our confidence in the potential of CD3-88 to offer robust -per-season protection against influenza A and B. Based on these robust data, we submitted our -phase-2 meeting request to the FDA to review the data and discuss the details of a Phase 3 study. This meeting has been scheduled for later this month. Once we have received the meeting minutes from the FDA, we plan to disclose key details of our planned Phase 3 study, including study design, dose selection, and timelines. We have guided previously to initiate this study in the Southern Hemisphere in the spring of 2026. Pending feedback from the FDA, we are confident that we can meet that goal. But we are also operationally prepared to start the study this fall should this become an option based on the outcome of our -phase-2 meeting. If we are able to start Phase 3 this fall, we believe that the study will enroll over the course of two flu seasons, the 2025-2026 Northern Hemisphere and the subsequent 2026 Southern Hemisphere flu season. Following the initial flu season, we plan to conduct an interim analysis for potential trial resizing. In Phase 3, we plan to focus our efforts initially on large populations with the highest unmet need, which includes high-risk comorbid and immune-compromised patients because they are disproportionately affected by influenza, as evidenced by substantially higher rates of hospitalizations and deaths, and are underserved by currently available vaccines and antiviral drugs. Our plan to address these high unmet need populations is the basis for CD388's current fast-track and priority review designations. In addition, based on the strength of the Phase 2B results, we have submitted to the FDA an application for breakthrough therapy designation and expect to hear the outcome of this application later this year. I would also add that we have submitted a proposal to BARDA, which, if funded, could provide meaningful funding to support manufacturing and additional clinical development studies of CD388. We expect to learn the outcome of this submission also by the end of this year. As we prepare to advance CD388 into Phase 3, 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 3 study. 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 CD388, both in the U.S. and -U.S. This includes work to highlight the burden of illness that influenza represents in our initial target population and the cost-offsets that could potentially be achieved with CD388. We plan to present the results of these activities in the coming months, following the conclusion of our discussions with the FDA regarding our Phase 3 plans. In closing, the data we have generated to date further validate our Cloudbreak DFC platform and the potential of CD388 to offer universal protection against both seasonal and pandemic influenza strains. While vaccines play a vital role in flu prevention, they do not offer sufficient protection, particularly for immune-compromised individuals, underscoring the need for a durable, broadly acting antiviral like CD388. We look forward to discussing our plan Phase 3 study design and trial start timeframe with the FDA shortly. With that, I will turn it back to the operator to take your questions.

Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing any keys. To withdraw your question, please press star then 2. Our first question is from Sheamus Fernandez with Guggenheim Securities. Please go ahead.

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 3 design that you shared with us during your Analyst Day. If there are any potential changes or meaningful changes that you're proposing or if you're simply looking for your Pre-Phase 3 discussion to just clarify those particular points from the Type C meeting. Then just as a follow-up question on BARDA, I was hoping to get a better understanding of exactly what you would hope to achieve with the grant. I don't know if that's something that you can discuss at this point, but I think we have some idea. But it would be interesting to just hear how that exercise is advancing and what the prospects might be for BARDA. The last question that I have is would that evolve to potentially become something that could incorporate orders? It's unclear if the administration is currently concerned about bird flu or other influenza spreading, but just interested to know what it takes to kind of move forward to actually get to orders should the BARDA grant be issued. Thanks so much.

Sure, Jonas. I'll provide some initial responses and then I'll welcome Nicole Taffarpanna to supplement. Regarding our upcoming meeting with the FDA and regarding your question of the difference from the Type C meeting, we don't have expectation of substantial differences. We largely reached alignment with the FDA in our Type C meeting in our discussions regarding the Phase 3 plan. The difference is that meeting took place in May before the Navigate Phase 2B results were available. Now that we have the results, this is the first opportunity to discuss those results within the context of the Phase 3 plan. Obviously based on the strength of the Phase 3 data and the strong safety that we observed, we don't anticipate substantial differences from that discussion. Regarding BARDA, as you are aware, when you submit these, there is a base period and option period. We have expectations that the base period will, if funded, would fund manufacturing, in particular the unshoring of manufacturing to the U.S. Then there are various options for the option period that which exercised could result in substantial funding to support additional clinical studies. And then finally, regarding any orders from BARDA, that would come in the form of an emergency use authorization in the event of a bird flu outbreak. We believe that based on the strength of the Phase 2B results, that would be an option should there be an outbreak. I would not anticipate a stocking order for CD388 in the absence of an emergency use authorization, however. So I'll invite Nicole to provide any additional color on those questions. Nicole?

Thank you, Jeff. I think you captured it quite nicely. And hello, Seamus. I think going back to the first point, as Jeff mentioned, we had a significant amount of alignment with the FDA on our trial population, the study design and endpoints. But of course, that was before the benefit of having this nice Phase 2 data. So we will then have this meeting currently to align with them further in case there's any changes, which we do not anticipate to the study design. And once we have received the meeting minutes, we will share openly any changes that have potentially been

made. Great. Thanks so much. The next question is from Eric

Schmidt with Counter Fitzgerald. Please go ahead.

Well, thanks for taking my question. Congrats on just a wonderful second quarter. Maybe just to continue Seamus' line of discussion around the upcoming FDA meeting. I assume first it's in August because I think you need to schedule those within 60 days so you can correct me if my timelines are off. But how would you plan to update investors on the outcome from that meeting? What actual points of discussion or questioning do you plan to put forth to

the FDA?

And then do you also plan to submit for a commissioner voucher? I would assume that CD388 might be a good fit for a national priority. Thank you. Sure, Eric. Yeah, all good questions. As discussed in the response to Seamus' question regarding the FDA meeting, this is the first opportunity really to discuss with them the Phase 3 plan in the context of the Phase 2B data. That meeting has been scheduled and we expect that it will occur by the end of this month. In response to your question about communication of the outcome of that meeting, we will await the receipt of the FDA minutes and then communicate those results and the results of those minutes in detail. With respect to your other question, I thank you, about the CMTV voucher, we have submitted a statement of interest to, you know, it was a 350-word statement of interest and we have yet to receive a response. I agree that CD388 would appear to be a very good fit. And was there another question, Eric, that I missed? I think you got it, unless you're willing, Jeff, to talk a little bit more about what you want to hear from the agency in your Pre-Phase 3 meeting before having a go decision on this season. Yeah, and again, I'll respond and I'll invite Nicole to provide any other color. Really, it's to corroborate the agreement we reached in our Type C meeting. So we haven't disclosed the details of that because obviously that can change based on the, in the Phase 2 meeting. So we will discuss those results when they become available in the form of the meeting minutes from the FDA. We don't anticipate substantial changes because the results of a Navigate study were pretty much in alignment with the expectations that we discussed with the FDA in the Type C meeting. Nicole, any other color you would like to add to that?

Thank you, Jeff. No, nothing for their time.

Thank you very much both.

The next question is from Brian Abraham with RBC. Please go ahead.

Hi, everyone. Thanks for taking our questions. This is Nebanon for Brian. So just wanted to follow up on a little bit more on the Phase 3 design that you proposed. So you're planning to enroll a more immunocompromised, higher risk population. So could there be a greater chance that the trial could reach the needed number of events earlier than the Navigate trial had reached those events? And can you explain some of the reasoning behind enrolling the trial over two to three influenza seasons, except just the one season as the Navigate trial? And then could you also remind us on the evidence that you've generated to date that suggests 388 can be redosed? And then do you imagine that regulators would want to see redosing potentially in the BIVITAL trial?

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

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 the needed number of events sooner than the Navigate trial had?

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 2B. And the main reason for that is even though, and I think what your question is alluding to is that this is a more vulnerable patient population. At the same time, they're a more protected patient population. And so they go because of the inadequacy of vaccines and protecting these patients. They are highly protected. And also a big difference is that we believe that at least half, if not more of these subjects will be vaccinated. Even though the vaccine effectiveness will be modest at best, it does offer some protection. In regard to your other question on redosing, yes, we do anticipate conducting a redosing study that is planned and is basically a continuation of redosing that we had conducted in our first Phase 1 study, where we are looking for anti-drug antibodies. We didn't see any substantial evidence of that. We also looked for those in the Phase 2B study. But we have this great resource in the subjects we enrolled in the Navigate Phase 2B study that have received a dose, three different doses of CD3-ADA. So we're going to take advantage of that resource and take a subset of those subjects for a redosing study that we anticipate starting shortly.

Okay, 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 pivotal trial or?

Good question. We'll communicate that after we receive the meeting minutes from our upcoming end of Phase 2 meeting because we'll be discussing that with the FDA. Okay,

great. Thank you so much.

Sure.

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

Good afternoon. This is Eddie, Arthur, Joey. Thanks for taking our questions.

Just two from us. First, just kind of to follow up on the previous question, wondering what assumptions are built into that cash runway. And does this include that redosing trial as well as the potential for a second Phase 3 trial? And then a follow up, just looking at the landscape, fantasy guidance for mid-teen percent of the economy in their food business this year, probably due to the US pricing pressures. I'm just curious what there, what read through might be possible for your business and

maybe some commercial outlets for CD3-88.

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

Yeah, sure. Hey, Eddie. So look, with the $500-plus million in cash on hand now, we believe we are adequately funded through the end of our Phase 3 program, including the additional studies that we have cited here on this call, and also including different potential scenarios, how the Phase 3 could play out.

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 Bidle, our Chief Business Officer. So if you could repeat that question first.

Yeah, absolutely. Just on Sanofi's earnings call, they guided for a mid-teen percent decline this year in their food business. And just seeing if there's any read through to your

business or commercial outlets for CD3-88. Yeah, Jim?

Thanks for the question. Certainly. Yeah, I appreciate the question. And certainly there's been a lot of downward pressure on vaccine businesses. I think not just Sanofi's, but others as well. And a lot of that has to do with things unrelated to CD3-88. 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 they're the burden of illness is highest and the value proposition that we've demonstrated in the Navigate study and intend to demonstrate in the Phase 3, I think really brings something unique to the marketplace. And so certainly downward pressure on vaccines, but a very different commercial model there relative to the one that we're considering for CD3-88.

Okay, thanks so much.

The next question is for Roy Buchanan with Citizens. Please go ahead.

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

Yeah, good questions. We have submitted to the ISIRV and ID week. And Les, do you want to provide a little color on whether those have been accepted yet? I don't believe they have, but we have high expectations that they will be accepted. Les? Yes,

Jeff and hi Roy. Yeah, we have two abstracts. We are submitting two abstracts to ISIRV, one to summarize the Phase 2B data and another that has been accepted for an oral presentation. And that's going to be on our activity against a contemporary H5N1 strain, a non-clinical ferret efficacy model where we demonstrated robust efficacy. As we, in the fall, we will also be presenting, we've submitted an abstract where we're going to be describing the PKPB relationships for

activity in the Phase 2B trial with CD388.

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

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

Okay, perfect. Thank you.

Once again, if you have a question, please press star then one. The next question is from Sarah Nick with HC Wingright. Please go ahead.

Hi, and thanks for taking the question. Just kind of following up on the previous one, wanted to get a sense of the resolution of the kind of data you'll be presenting at these conferences. You mentioned some PKPB 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? Thank you.

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

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

All right, great. Thank you.

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

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

The conference is now concluded. Thank you for attending today's presentation.