Solcuity reports strong phase 3 results for gatalisib, plans FDA submission and commercial launch in 2025 amid significant financial backing.

OPERATOR - (00:00:00)

Sam Good afternoon ladies and gentlemen and welcome to the Celcuity second quarter 2025 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 require immediate assistance, please press Star zero for the operator. I would now like to turn the conference over to Apoorva Virtuluri with ICR Healthcare. Please go ahead.

Apoorva - (00:01:57)

Thank you operator and good afternoon to everyone. Thank you for joining us to review Selcuity SECond quarter 2025 financial results and Business Update earlier today Celcuity Inc. Released financial results for the SECond quarter ended June 30, 2025. The press release can be found on the Investors SECtion of Celcuity's website. Joining me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and Co Founder, Vicky Hahn, Chief Financial Officer, as well as Igor Gorbachevsky, Chief Medical Officer, who will be available during Q and 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 Celcuity. Please go ahead.

Brian Sullivan - Chief Executive Officer and Co-Founder - (00:03:36)

Thank you Apoorva and good afternoon everyone. Thank you for joining our second Quarter financial results conference call. Past few months have been eventful ones for Celcuity. We achieved several significant milestones and we believe these milestones lay the foundation for us to potentially establish Gedatolisib 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 3 Victoria 1 clinical trial in patients with HR positive HER2 negative PIK3CA wild type advanced breast cancer GADA solicit plus fulvestrant and palbociclib or the Gedatolisib triplet and Gedatolisib plus fulvestrant or the Gedatolisib doublet met the study's two primary endpoints by demonstrating statistically significant and clinically meaningful improvement in progression free survival or PFS versus fulvestrant. The recorded 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. The implications are profound for patients with HR positive virtue negative advanced breast cancer as we seek to advance gettelisib 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 3 Victoria 2 clinical trial. This trial is evaluating Genetelisib in combination with a CDK4.6 inhibitor and fulvestrant as first line treatment for patients with HR positive HER2 negative advanced breast cancer. The third milestone was the announcement of favorable preliminary top line results from two early phase clinical trials, one evaluating gets Elizabeth and Darolutamide in men with metastatic castration resistant prostate cancer and a second one that evaluated getatulisib and a trastuzumab biosimilar in patients with HER2 positive PIK3C and mutated metastatic breast cancer. Fourth milestone was the extension of our patent exclusivity for GETA to Lisa into 2042 with the issuance of a new dosing regimen patent for get it to LISIB. 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 and launch gatalis should we get FDA approval next year. I'd like now to turn to the Victoria one trial. Last month we announced top line results from this trial. Median progression free survival or PFS for the gas triplet was 9.3 months compared to only 2 months for Fuvestrin 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 Gadathilisib triplet than Fulvestrin. For the Gadathilisib doublet, median PFS was 7.4 months, again compared to only 2 months for flovastrin 5.4 months. Incremental improvement in median PFS, the hazard ratio was 0.33, which translates to 3 times higher likelihood of survival without disease progression where they get a Thalisa doublet in full vestrin now. These results establish several new milestones in the history of drug development for this patient population. First, the hazard ratio is reported for both the GETA 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 3 trial for this patient population receiving at least their second line of therapy for advanced disease. And third, gatafilicid is the first PAM inhibitor to achieve a positive phase 3 data result in patients with PIK3CA wild type tumors and whose disease progressed on or after treatment with a CDK4.6 inhibitor. For comparison purposes, it's important to note that several phase three studies in this patient population have reported data recently. In these studies, 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 gadolysib 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 for the getafilosib regimens than the other currently available for investigational agents. We believe both the Gedatolisib 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 Ghetta based on data from the PIK3CA wild type 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 PIK3CA 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 potential launch should we get FDA approval. We think the market looks very promising for get us listed. 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 for more efficacious therapies than those currently available. Currently approved Therapies only offer two to four months of median PFS. With GaddaFilm's unique mechanism of action corresponding clinical benefit, it's well 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, ethic 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 GADDA solicit will be very well received in the community practice setting where over 80% of patients are treated. Betafilisib 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 a treatment regiment. 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 Gedatolisib 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 three Victoria 2 trial. Last month we announced that we dosed the first patient in Victoria thru that's evaluating get us illicit plus a CDK4.6 inhibitor that the investigator may choose and fulvestrant 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 includes any one of three approved CDK4.6 inhibitors combined with fulvestrant 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 PIK3CE WA type cohort of our Victoria 1 study augurs well for the gadylisib triplet in this patient population. I'd like now to turn to our phase 1b2 clinical trial that's evaluating gatalisib 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 or combined with either 120 milligrams of Gadifilisib in ARM1 or 180 milligrams of Gadifililisib in ARM2 and Gadifilisib 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 get us elicit dope dose for this patient population may not yet have been reached and we believe it's important to explore additional dose options for gatalysts 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 getafilicib 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. 86% of patients had received at least three prior anti HER2 therapies so these patients were heavily pre treated. The overall response rate was 43% and no patients discontinued getthelisib due to a treatment related adverse event. Achieving 43% overall response rate in patients receiving a fourth or fifth line of anti herta 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 its listed 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. First, the US Patent and Trademark Office issued Solcuity a new patent covering the clinical dosing regimen for gadotelicid and in HR positive HER2 negative breast cancer patients. The patent extends get it Elisib's patent exclusivity in the US into 2042 and with this added patent exclusivity we expect to have a long Runway to optimize development of Getat, Elisabet. And last but not least, we also completed concurrent offerings of convertible notes, common stock and pre funded warrants with net proceeds of 286 million and a half 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 gadatalisib commercially should we receive FDA approval. I'd like now to hand the call over to Vicky Hahn, our CFO to review our finances.

Vicki Hahn - (00:16:18)

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 17.7 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 was approximately $455 million. Additionally, existing financing arrangements 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.

Brian Sullivan - Chief Executive Officer and Co-Founder - (00:19:31)

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.

OPERATOR - (00:19:46)

STAR followed by the number one.

Amin Anvor Mori - (00:19:47)

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 Raycraft from Jefferies. Please go ahead. Hi, this is Amin Anvor 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 PIK3CA wild type portion of the full phase three study, can you elaborate on what we should expect to see? Specifically, will you be sharing subgroup analysis such as PFS and OS4ESR1 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 PQC MUT 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 were reviewing the data in that cohort. The first is the comparison to the control, which in this case is alpelisib fulvestrin. As it turns out, given what we think is the likely outcome based on historical data for epilepsy in this population of between, let's say seven to eight months, a statistically significant result would also be a clinically meaningful result of 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 alpelisib 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 kappavacetrip and 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 apelipsid, those will be especially positive relative to capivasertib. Okay, sounds good. Thank you. You're welcome. Your next question is from the line of Tara Bancroft from TD Cowan. Please go ahead.

Frances - (00:22:46)

Hi, this is Frances on for Terra 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?

Brian Sullivan - Chief Executive Officer and Co-Founder - (00:23:07)

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.

Frances - (00:23:22)

Thank you.

Esinofer - (00:23:25)

You're welcome. The next question is from the line of Andrew Behrens from Learning Partners. Please go ahead. Hi, good afternoon, this is Esinofer. 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 BICR, as is the case in Victoria one 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 BICR versus investigator assessment based on what we've seen in prior HR positive Herd two 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 gadathosib 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 the trials for the recent oral surge. You know, the Emerald trial and the Vertex 2 trial were also BICR studies because again, not plausible to create a placebo for Fluvestrin. And so BICR is the method that the FDA actually encourages or recommends when you do have an open label study for that purpose. And so in this case, then the investigator data is really simply 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 in the sequence, as we move from one conference to another. But into your question regarding concordance, I think I saw one study that showed the concordance between the hazard ratios. But BICR PFS and The investigator assessed PFS were, I think, correlated well over 90%. It may even have been 95%. And so we do not expect to have any issues on that front in the processes 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 all the sensitivity analyses are indicating that their 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 Stephen Wiley from Siphone. 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, 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, a couple points to highlight. First, we began building our team last year. We hired our chief commercial officer Elgin Meyer in first quarter 2024 and then he in turn brought on board head of marketing, head of market access, head of commercial operations. And they focused on projects that 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. You have to assume an earlier launch date or you're kind of aggressive on when you think that will occur, just so you're not blindsided and you're ready under any circumstance. And now as we've gotten closer to launch these past few months, we've begun hiring the individuals who report up to the heads of these various departments and in turn they've been taking on, 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 Salesforce, the supporting 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, 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 first drug launch for a company. And that's critical because there's so much infrastructure, operational support activities that are required to be effective as a commercial organization. You know, it's not a plug and play. Somebody coming from big pharma has never had to set up, you know, all of, 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, you know what we think we're optimistic about the launch and our ability to be very, very effective in communicating the benefits of geta. What we believe are the benefits of geta to medical oncologists. All right, thanks. Second question. You're welcome. Your next question is from the line of Gil Blum from Nedan and company. Please go ahead. Hi, this is Gilmon for Gill. 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 immune. An immune system that may be more compromised, 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 for different subgroups for physicians and how they might want to think about the doublet versus the triplet as an example. Thank you. Very helpful. And just 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 de. Detailed, you know, operating plan and operating budget. We know what the headcount is and when 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 the 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, Nicker, Barger from Craig. Helen, 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 co. 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, too early thoughts as far as the competitive environment there and how you see kind of get it fitting in. Right. So you know, I think two things. I mean for PIT for mutation patients will 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 get 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 SURD to address that pathway. And at the same time, we think if you are addressing the PAM pathway in CDK4.6, the relative difference in outcomes between ESR1 mutant and wild type patients is unlikely to be meaningfully different. Got it. Maybe just on the, on the mutant side to dig in a little bit there, you know, obviously the most recent approval there with it of ebbi. 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, and any relevant comparisons there? Sure. So I kind of still use the generic name Inovalisib. That drug is an alpha in hip PI3K alpha inhibitor. It's approved for treating patients who have a PIK3CA 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 PAMP pathway and their disease and their benefit. In this case, you know, this drug has only shown activity, unfavorable activity in patients that have a PIK3CA mutation. That drug also has some induces levels of hypoglycemia that can potentially limit its use to patients who are healthy metabolically, 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 GETA can be effective in treating patients independent of their PIK3CA status and independent of their metabolic status and independent of their HVA1C 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, your manufacturer there, you know, any specifics you're willing to give as far as your kind of confidence around your CMC package? We're very confident about the CMC package. You know, we, 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 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 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, 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 and 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 SA.