Celcuity Inc.

Good afternoon, ladies and gentlemen, and welcome to this second quarter 20-25 Financial Results webcast and conference 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're requiring immediate assistance, please press star zero for the operator. I would now like to turn the conference over to a poor artillery with IC or healthcare. Please go ahead.

Thank you, operator, and good afternoon to everyone. Thank you for joining us to review Salcuity's second quarter 2025 financial results and business update. Earlier today, Salcuity Inc. released financial results for the second quarter ended June 30th, 2025. The press release can be found on the investor section of Salcuity's website. Joining me on the call today are Brian Sullivan, Salcuity's chief executive officer and co-founder, Vicky Han, chief financial officer, as well as Igor Gorbachevsky, Chief Medical Officer, who will be available during Q&A. Before we begin, I would like to remind listeners that our comments today will include some forward-looking statements. These statements involve a number of risks and uncertainties, which are outlined in today's press release and in our reports and filings with the SEC. Actual events or results may differ materially from those projected in the forward-looking statements. Such forward-looking statements and their implications involve known and unknown risks uncertainties, and other factors that may cause actual results or performance to differ materially from those projected. On this call, we will also refer to non-GAAP financial measures. These non-GAAP measures are used by management to make strategic decisions, forecast future results, and evaluate the company's current performance. Management believes the presentation of these non-GAAP financial measures is useful for investors' understanding and assessment of the company's ongoing core operations and prospects for the future. You can find the table reconciling the non-GAAP financial measures to GAAP measures in today's press release. And with that, I would now like to turn the call over to Brian Sullivan, CEO of Selcuity. Please go ahead.

Thank you, Apoorva, and good afternoon, everyone. Thank you for joining our second quarter financial results conference call. The past few months have been eventful ones for Selcuity. We achieved several significant milestones. And we believe these milestones lay the foundation for us to potentially establish gadotelicib as a new standard of care therapy for patients with HR-positive, HER2-negative, advanced breast cancer. First, and most importantly, of course, was the positive top-line data we've reported from the PIK3CA wild-type cohort of our Phase III Victoria I clinical trial. In patients with HR-positive, HER2-negative, PIK3CA wild-type, advanced breast cancer, gadotelicib plus fulvestrin and pavaciclib or the get a solicit triplet, and get a solicit plus fulvestrin, or the get a solicit doublet, met the study's two primary endpoints by demonstrating statistically significant and clinically meaningful improvement in progression-free survival, or PFS, versus fulvestrin. The reported hazard ratios and improvements in median PFS are unprecedented in HR-positive HER2-negative advanced breast cancer. We believe these data validate our hypothesis that the role of the PIK3CA or PI3K, AKT, mTOR, or PAM pathway as a cancer driver is not solely a function of the presence of a pathway mutation. And the implications are profound for patients with HR-positive virtue-negative advanced breast cancer as we seek to advance Get It to Listen as a therapeutic option for patients with or without PIK3CA mutations in both the second-line and first-line settings. Second important milestone achieved was the dosing of the first patient in our Phase III Victoria II clinical trial. And this trial is evaluating Gettysalicib in combination with a CDK4-6 inhibitor and fulvestrin as first-line treatment for patients with HR-positive for a two-negative advanced breast cancer. The third milestone was the announcement of favorable preliminary top-line results from two early-phase clinical trials. One, evaluating Gettysalicib and darolutamide in men with metastatic castration-resistant prostate cancer. And the second one that evaluated get a solicit and a bio similar. In patients with her to positive pictures, get mutated metastatic breast cancer. 4th, milestone was the extension of our patent exclusivity for get a solicit into 2042 with the issuance of a new dosing regimen patent. Forget it to listen. And finally. We raised around $287 million through public offerings of convertible notes, common stock, and pre-funded warrants that provide the funding that should allow us to aggressively prepare for our long-scan solicit should we get FDA approval next year. I'd like now to turn to the Victoria 1 trial. Last month, we announced top-line results from this trial. Median progression-free survival, or PFS, for the death solicit triplet was 9.3 months. compared to only two months for fulvestrin, 7.3 months incremental improvement in median PFS. The hazard ratio was 0.24, which translates to 4.2 times higher likelihood of survival without disease progression for the gadotilisib triplet than fulvestrin. For the gadotilisib doublet, median PFS was 7.4 months, again, compared to only two months for fulvestrin, 5.4 months incremental improvement in median PFS. The hazard ratio was 0.33, which translates to three times higher likelihood of survival without disease progression for the get a felicitous doublet than fulvestrin. Now, these results established several new milestones in the history of drug development for this patient population. First, the hazard ratios reported for both the get a triplet and doublet were the most favorable ever reported by any phase three trial, first line, second line, or third line in this population. And second, the incremental improvements In median PFS for the triplet and doublet, 7.3 and 5.4 months, respectively, were the highest ever reported by any Phase III trial for this patient population, receiving at least their second line of therapy for advanced disease. And third, getafilicid is the first PAM inhibitor to achieve a positive Phase III data result in patients with PIK3CA wild-type tumors and whose disease progressed on or after treatment with a CDK4-6 inhibitor. And for comparison purposes, it's important to note that several phase three studies in this patient population have reported data recently. In these studies, the incremental improvement in median PFS ranged from 1.7 to 3.9 months, and the hazard ratios ranged from 0.55 to 0.73. Both gas elicit regimens exhibited a favorable safety profile, including lower rates of hyperglycemia and stomatitis. And the rate of discontinuation of all treatment due to a treatment-related adverse event was lower than was reported in a Phase 1b study in this patient population. In light of the favorable safety profile, more favorable hazard ratios, and longer incremental PFS with the Getifilicib regimens than the other currently available or investigational agents, we believe both the Getifilicib triplet and doublet each have the potential to establish a new standard of care for these patients. We're on track to submit a new drug application to the FDA in the fourth quarter of 2025 for data based on data from the PIC3CA WildSide cohort. And we're looking forward to presenting the full data set later this year at an upcoming medical conference. Additionally, we expect to release top line data for the Victoria 1 PIC3CA mutation cohort by the end of 2025. Moving on, I want to share just a quick overview of the market landscape we see for Get It to Listen and how we're gearing up for a potential launch should we get FDA approval. We think the market looks very promising for Get It to Listen. We estimate there are 34,000 patients moving to second-line treatment after progressing on a CDK4-6 inhibitor, and roughly 60% of them are PIK3CA wild-site. That's a very large opportunity. And there's also a significant need for more efficacious therapies than those currently available. Currently, approved therapies only offer two to four months of median TFS. We've got a solicit unique mechanism of action, corresponding clinical benefit. It's all positioned to address critical needs in the second-line space. And this unmet need has been verified in our market research, which shows that oncologists are hungry for options that are more effective and have a safety profile they can manage. And as we've discussed on prior calls, Efficacy and safety are the two primary criteria oncologists use to select therapies for their patients. This is also consistent with the criteria used by treatment guidelines, such as NCCN, to determine recommendation categories for drug treatments. Additionally, as an IV-administered therapy, we believe Gettys Illicit will be very well received in the community practice setting, where over 80% of patients are treated. Gettys Illicit will fall under the medical benefit category, which means typically smoother reimbursement process compared to oral drugs that fall under the pharmacy benefit category. For oral drugs, payers tend to manage claims more heavily, resulting in a more cumbersome prescribing and reimbursement process for practices. And unlike oral drugs, IV-administered therapies also allow physicians to recover costs associated with the purchase and administration of therapy and to better ensure patient compliance with the treatment regimen. And finally, The breast cancer community is active, engaged, and well-supported by advocacy groups, which will help create awareness for new treatments in general, and we think for Gettysburg specifically. As a result, we believe Cellcuity has the opportunity to build strong presence amongst medical oncologists to address this large, underserved patient population. And based on our projections, we believe the addressable market potential for a standard of care second-line therapy to treat this patient population is roughly $5 billion. I'd like now to turn to our phase 3 Victoria 2 trial. Last month, we announced that we dosed the first patient in Victoria 2 that's evaluating, get a solicit, plus a CDK4-6 inhibitor that the investigator may choose, and fulvestrin as first-line treatment for patients who have endocrine therapy-resistant, HR-positive, HER2-negative advanced breast cancer. The standard of care first-line treatment for most Endocrine therapy-resistant patients includes any one of three approved CDK4-6 inhibitors combined with filvestrin. And results from a recent trial suggest the median progression-free survival period for patients receiving one of these three regimens is only about seven to eight months, and highlighting the significant need for more efficacious frontline therapy for these patients. We believe the positive top-line data from the PIK3CY type cohort of our Victoria 1 study augurs well for the getathelicib triplet in this patient population. I'd like now to turn to our Phase 1B2 clinical trial that's evaluating getathelicib in combination with darolutamide in men with metastatic castration-resistant prostate cancer. In late June, we announced encouraging Phase 1B preliminary efficacy and safety data from this study, which enrolled 38 prostate cancer patients who were randomly assigned to either receive 80 milligrams of darolutamide twice daily combined with either 120 milligrams of getafilicib in arm one or 180 milligrams of getafilicib in arm two. And getafilicib was administered once weekly for three weeks and then one week off in both arms. The preliminary analyses for the combined arms show the six-month radiographic PFS rate was 66%, which compares favorably to published data for androgen receptor inhibitors in this setting. Additionally, the data highlighted the favorable safety profile of this novel combination. There were no treatment-related discontinuations, and less than 3% of patients experienced grade 3 stomatitis. These data indicate that the optimal getafilicid dose for this patient population may not yet have been reached, and we believe it's important to explore additional dose options for getafilicid. And as such, we amended the clinical trial protocol. to enable exploration of additional doses in the Phase 1b portion of this clinical trial to determine the recommended Phase 2 dose. In addition to announcing the encouraging preliminary data from our prostate cancer trial, we also announced encouraging data from an investigator-sponsored Phase 2 clinical trial. In this trial, 44 patients with HER2-positive PIK3CA-mutated breast cancer were treated with getafilicid plus standard doses of a trastuzumab biosimilar. No prophylaxis for stomatitis was administered. The median number of prior anti-HER2 therapies enrolled patients received in the metastatic setting was four or more. Eighty-six percent of patients had received at least three prior anti-HER2 therapies, so these patients were heavily pretreated. The overall response rate was 43 percent, and no patients discontinued detethylizib due to a treatment-related adverse event. Achieving 43 percent overall response rate in patients receiving a fourth or fifth line of anti-HER2 treatment for their disease is very encouraging and compares favorably to published data for other available therapies in this group of patients. It also suggests to get it solicited in combination with HER2 targeted therapy may be an effective and well-tolerated therapeutic option for patients with HER2-positive metastatic breast cancer. Now, I'd like to turn to a few corporate updates. The U.S. Patent and Trademark Office issued Salcuity a new patent covering the clinical dosing regimen for Get It to Listen in HR-positive, HER2-negative breast cancer patients. The patent extends Get It to Listen's patent exclusivity in the U.S. into 2042. And with this added patent exclusivity, we expect to have a long runway to optimize development of Get It to Listen. And last but not least, we also completed concurrent offerings of convertible notes, common stock, and pre-funded warrants with net proceeds of $286.5 million at the end of July and beginning of August. With our current resources and other financing arrangements, we believe we are well positioned to advance multiple blockbuster indications in breast and prostate cancer and to aggressively prepare for and launch Gettysburg commercially should we receive FDA approval. I'd like now to hand the call over to Vicki Hahn, our CFO, to review our finances.

Thank you, Brian, and good afternoon, everyone. I'll provide a brief overview of our financial results for the second quarter of 2025. Our second quarter net loss was $45.3 million, or $1.04 per share, compared to $23.7 million net loss, or $0.62 per share, for the second quarter of 2024. Our non-GAAP adjusted net loss was $40.5 million, or $0.93 per share, for the second quarter of 2025 compared to non-GAAP adjusted net loss of $22.2 million or $0.58 per share for the second quarter of 2024. Research and development expenses were $40.2 million for the second quarter of 2025 compared to $22.5 million for the second quarter of 2024. Of the approximately $15.7 million increase in R&D expenses, $6.6 million was related to increased employee and consulting expenses, $6.1 million was related to increased research and development costs, primarily attributable to activities supporting our ongoing clinical trials, and $5 million is related to an anticipated development milestone payment under the license agreement with Pfizer. General and administrative expenses were $3.8 million for the second quarter of 2025 compared to $1.8 million for the second quarter of 2024. Of the $2 million increase in general and administrative expenses, $1.6 million was related to increased employee and consulting expenses. The remaining $0.4 million of the $2 million increase resulted from professional fees expanding infrastructure and other administrative expenses. Net cash used in operating activities for the second quarter of 2025 was $36.2 million compared to $18.1 million for the second quarter of 2024. We ended the quarter with approximately $168.4 million of cash, cash equivalents and short-term investments. However, on a pro forma basis, taking into account the net proceeds of our financing activities in Q3, cash, cash equivalents, and short-term investments as of the end of Q2 2025 with approximately $455 million. Additionally, existing financing arrangements are expected to give us access to an incremental $116 million of cash over the next few quarters. 80 million from our current term loan agreement and 36 million from the exercise of soon to expire in the money warrants. As a result, we believe we have the resources and financing in place to fund our operations through 2027. I will now hand the call back to Brian.

Thank you, Vicki. Operator, could you please open the call for questions? Thank you very much.

Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the number one on your touchstone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the number two. If you are using a speakerphone, make sure to lift your handset before pressing any case. Your first question comes from the line of Maury Raycroft from Jefferies. Please go ahead.

Hi, this is Amin Anfor Mori. Thank you for taking our questions, and congrats on all the progress. A couple of questions from us. First, regarding the upcoming full data presentation later this year for PIC2ECL wild-type portion of the Phase III study, can you elaborate on what we should expect to see? Specifically, will you be sharing subgroup analysis, such as PFS and OS for ESR1 wild-type and mutant cohorts there? And then I have a follow-up.

Sure. So we'll be focused on our initial data presentation on the primary analyses, the primary endpoints, and then we would expect to present data at subsequent meetings, additional subgroup analyses.

Okay, sounds good. And for the PIC2C mute population, how are you thinking about the benchmarks for success here? Is there a specific hazard ratio or PFS delta that you are considering a meaningful threshold there and could be considered clinically meaningful?

Sure.

So, I think there are two thresholds to consider when we're reviewing the data in that cohort. The first is the comparison to the control, which in this case is epilepsy and fulvestrin. As it turns out, given what we think is the likely outcome based on historical data for epilepsy in this population of between, you know, let's say seven to eight months, a statistically significant result would also be a clinically meaningful result of, you know, a little less than three months. So, we think if we have a positive study, we'll also be reporting clinically meaningful results. Additionally, because opalypsib is probably no longer the primary option that physicians are relying on, we think from a practical standpoint, the benchmark data that physicians will consider will be the data for Kappa-vaciturbin-AKT inhibitor. And Kappa data is reported data in the post-CDK population of about five and a half months of median PFS. So, if we're able to report positive results relative to opalypsib, those will be especially positive relative to our cathavassature.

Okay. Sounds good. Thank you. You're welcome.

Your next question is from the line of Tara Bancroft from TD College. Please go ahead. Hi.

This is Frances on for Tara Bancroft. So, just one question on our end. So since the full safety data isn't broken out in the top line, is there any more detail you can offer ahead of it? If there's better rates observed, was that overall rates or just grade three stomatitis?

Sure. So we'll be providing that data at the upcoming conference. We were really only at this stage able to provide a general summary of what we saw, but the additional detail will be forthcoming.

Thank you.

You're welcome. The next question is from the line of Andrew Behrens from Learing Partners.

Please go ahead.

Hi. Good afternoon. This is for Andy. Congrats on all the progress, and thanks for taking our questions. Just a two-parter, if I can. So we noticed across various pivotal trials in the HR-positive, HER2-negative breast cancer space, It's been mixed whether the PFS primary endpoint was based on Vickr, as is the case in Victoria 1, or based on investigator assessment. So first question is, can we expect the PFS analysis based on investigator assessment to be presented at an upcoming meeting later this year? And then second, what is the company's understanding on the concordance between Vickr versus investigator assessment based on what we've seen in prior HR-positive, HER2-negative trials? as well as how is this aspect evaluated by FDA and other regulatory agencies?

Thank you.

Sure.

No, thanks. So, the selection of BICR for our study as the assessment method was a function of our study being an open-label study. And that just reflects that Gatafosib is an IV-administered drug, and you can't really have a plausible placebo. And you use blinded assessment of the scans to ensure that you're eliminating the potential for investigator bias. And that's why you saw, see that the trials for the recent oral surge, you know, the Emerald trial and the Veritac 2 trial were also bigger studies because, again, not plausible to create a placebo for fulvestrin. And so, BICR is the method that the FDA actually encourages or recommends when you do have an open-label study for that purpose. In this case, then, the investigator data is really simply, you know, collected as part of ongoing assessment, and it's more for exploratory sensitivity analysis. And so, it's not a fundamental analysis, and we'll be reporting data, as I indicated earlier, you know, in the sequence as we, you know, move from one conference to another. But into your question regarding concordance, I think I saw one study And so, the concordance between the hazard ratios of a bigger PFS and the investigator-assessed PFS were, I think, correlated well over 90 percent. It might even have been 95 percent. And so, you know, we do not expect to have any issues on that front. You know, we've And the process is we prepare for NDA doing sensitivity analyses, many of which were prescribed by the FDA in our discussions with them about our statistical analysis plan. And, you know, all the sensitivity analyses are, you know, indicating that our data is very robust and we're very comfortable and confident about the package that we expect to submit to the FDA.

Great. Thank you. The next question is from the line of Steven Wiley from Seifel.

Please go ahead.

Yeah, good afternoon. Thanks for taking the question. I was just wondering how you're now thinking about launch readiness. You're going to be filing an NDA here in the fourth quarter. You've got breakthrough. Presumably there's an RTOR pathway you can leverage. So what are some of the comps, I guess, that you look to in terms of the requisite amount of infrastructure build that you need? And how do you think about scaling that infrastructure here over the near term and as we get into 26?

Sure. No, that's a great question. So it's a couple of points to highlight. First, we began building our team last year. We hired our chief commercial officer, Eldon Meyer, in first quarter 2024. And then he, in turn, brought on board a head of marketing, head of market access, head of commercial operations. and and they focused on uh projects that uh have a long lead time and there are a variety of those that can take up to 18 months to get done and so essentially we've been working back from a launch date uh you have to assume an earlier launch date or you're kind of aggressive on when you think that'll occur just so you're not blindsided and you're ready under any any circumstance and now as we've gotten closer to launch these past uh few months uh we've begun hiring the individuals who report up to the heads of these various departments. And in turn, they've been taking on more projects. Now that we have our data, we have what we think is a clear path to an approval decision, which we can kind of, where we can define with some degree of confidence a launch date, we'll be taking that next step. And so, that'll involve, you know, additional infrastructure associated in the commercial operations area to support a sales force, to support an MSL force, There's activities in the market access area, engaging with payers, strategic accounts in ways that are appropriate at this stage. And then in turn, you start to build out your Salesforce management structure, starting with head of sales and then regional management, which in turn requires you to define sales territories, number of territories, the geographic alignment, et cetera. So all those projects are on track. And as far as, you know, how are we doing, you know, or what is our benchmark, we've been very deliberate about hiring folks in all of these key positions, people who have been involved in first launch of a company's drug, first drug launch for a company. And that's critical because there's so much, you know, infrastructure, operational support activities that are required to be effective as a commercial organization. It's not a plug and play if somebody coming from big pharma has never had to set up all of this infrastructure or to establish these processes and these functions from scratch. So I think we've been very, very fortunate. We've hired a great team, incredibly experienced, very focused, and I think we're absolutely on track to having what we think. We're optimistic about the launch and our ability to be very, very effective in communicating the benefits of what we believe are the benefits of GEDA to medical oncologists.

All right. Thanks for taking the question. You're welcome. Your next question is from the line of Gail Blum from Need I'm in Company.

Please go ahead.

Hi, this is Gail Blum for Gail. So just a couple from us. Can you put into context the practical ramifications for physicians now that they may have optionality with both a doublet and a triplet and have a follow-on?

Well, I think the primary, I think, goal of all these physicians is to optimize and delay as long as possible the progression of a patient's disease, and the triplet offers that to these doctors. Now, the triplet, because it includes polycycline, also induces some myelosuppression, you know, which for patients who could be elderly or have an immune system that may be more compromised, you know, they may consider not to be appropriate. And so, they'll have the option of still getting very, very, what we believe, extended incremental benefit in PFS. And so, what we think having either regimen available does is allow us to have access to as broad a range of patients as possible. And that's always great. And then I think as we get into and describe results for different subgroups, I think that will help guide some of the decision making, you know, for different subgroups for physicians and how they might want to think about, you know, the doublet versus the triplet as an example.

Thank you, very helpful. And just as a follow-on to Steve's question, is there any consideration on commercial partnering strategy for a launch? I mean, it looks like it might be a very large investment just given the size of the market. Thank you.

No, we're expecting and planning to launch ourselves. We think we understand what's required. We know what's required. We have a very, very detailed plan you know, operating plan and operating budget. We know what the head count is and why we need to bring them on. You know, the investment is not insignificant, but it's not ridiculous, to be frank. And, you know, relative to the size of the opportunity, it's very manageable. And so we've financed ourselves accordingly. That's the other part of the equation, obviously, is having sufficient capital. to invest aggressively in a launch. And we think we've set ourselves up very well with our balance sheet to do that. And so just purely from a financial perspective and financial return perspective, it makes absolute sense for us to be launching this ourselves and not to be partnering with somebody.

Thanks for taking our questions. You're welcome.

Your last question comes from the line of Chase Knickerbarger from Craig Hallam. Please go ahead.

Good afternoon. Thanks for taking the questions. Maybe, Brian, just to start, can you kind of just give us your general thoughts on kind of the competitive landscape in the mutant population? You know, there's obviously some other actionable mutations in there with ESR, et cetera. So can you just give us, you know, your general, you know, two early thoughts as far as the competitive environment there and how you see kind of Geta fitting in?

Right. So, you know, I think two things. I mean, for PIP3C mutation patients, we'll be reporting out that data later this year. Obviously, if our data is positive and shows benefit relative to epilepsy, we think that'll position us very well to establish GATA as a new potential standard of care. So, we'll be taking we think that'll kind of speak for itself. As far as the ESR1 mutations, we just don't think they'll be as relevant, you know, given the nature of the drug combination that we have. You know, in the absence of inhibition of, let's say, CDK4-6 or the PAM pathway, potentially in ESR1 mutant patients, I mean, data suggests that you can get some incremental benefit if you use an oral SIRG to address that pathway. And at the same time, we think if you are addressing the PAN pathway and CDK4-6, the relative difference in outcomes between the SR1 mutant and wild-type patients is unlikely to be meaningfully different.

Got it. Maybe just on the mutant side to dig in a little bit there. You know, obviously, the most recent approval There with Itavebi, I mean, can you just give us some thoughts as far as kind of how the market's changed in the last kind of 10, 12 months and any relative comparisons there?

Sure. So I kind of still use the generic name, Inovilicib. That drug is an alpha inhibitor, it's approved for treating patients who have a PIK3C mutation in the first-line setting for women who have endocrine treatment-resistant disease, advanced disease. And that's actually the patient population that we're addressing in our Victoria 2 study. So that population doesn't overlap at all with the population that we'll be addressing with the Victoria 1 study results. And so the data does provide confirmation that in the frontline setting, treatment naive patients have involvement of the PAM pathway in their disease and they'll benefit. In this case, you know, this drug, has only shown activity, unfavorable activity, in patients that have a PIK3C mutation. That drug also, you know, has some, you know, induces levels of hypoglycemia that, you know, can potentially limit its use to patients who are healthy metabolically, you know, which means they are not pre-diabetic or not diabetic at all. And we would hope, and that's what our trial will evaluate, that get a can be effective in treating patients independent of their PIK3CA status and independent of their metabolic status and independent of their HbA1c levels or glucose levels. And so, ultimately, if our data from wild type recapitulates in the Victoria 2 study and we show activity generally, we think we have another opportunity to establish GETA as a potential standard of care.

Thanks, Brian. And maybe just one more if I could sneak it in. On the CMC portion of your filing, when you submit it in Q4, can you just remind us, you know, your manufacturer there, you know, any specifics you wanted to give as far as your kind of confidence around your CMC package?

We're very confident about the CMC package. You know, we have all the data. Our modules are complete for CMC. You know, there's a very prescribed set of studies that are expected. analyses to be performed, you know, kind of a number of demonstration of consistency of your process, and that's all been done. So, we're very confident, just based on the robustness of the package that we've built and the data that we've generated, that, you know, we should satisfy the FDA's requirements. And we've also engaged directly with the FDA and ensured that There aren't any open questions based on an outline that we've provided to them of the data we expect to provide. And so, we think we should be in good shape on that front.

Great. Thanks, Brian.

You're welcome. There are no further questions at this time. I'd like to turn the call back to Mr. Brian Sullivan for closing comments. Sir, please go ahead.

Well, thank you for participating in our call today. Thank you for your ongoing support, and I look forward to catching up with you at various conferences along the way.

Take care. Ladies and gentlemen, this concludes today's conference call. Thank you very much for your participation. You may now disconnect.