Greetings and welcome to the Relmada Therapeutics fourth quarter and full year 2021 earnings call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Tim McCarthy of LifeSci Advisors. Thank you, Tim. You may begin. Thank you, Paul, and thank you all for joining us this afternoon. With me on today's call are Chief Executive Officer Sergio Traversa and Chief Financial Officer Maged Shenouda. This afternoon, Relmada issued a news release providing a business update announcing financial results for the three and 12 months ended December 31st, 2021. Please note that certain information discussed on the call today is covered under the safe harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, Relmada's management team will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business. These forward-looking statements are qualified by the cautionary statements contained in Relmada's press release issued today and the company's SEC filings, including in the annual report on Form 10-K for the year ended December 30th, 2020, and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, March 23rd, 2022. Relmada undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. Now I would like to turn the call over to Sergio. Sergio. Thank you, Tim, as always, and good afternoon to everyone. I'm pleased to welcome you to the Relmada fourth quarter and full year 2021 conference call. During today's call, I will review our recently achieved milestones and provide an update on anticipated clinical trial readouts timeline for REL-1017, our lead product candidate that we are currently studying as an adjunctive treatment and monotherapy for patients with major depressive disorder or MDD. Following my comments, Maged Shenouda, our Chief Financial Officer, will review the financial results and recently strengthened balance sheet, and we'll then take your questions. Looking ahead, we expect 2022 to be a catalyst switch year for Relmada. We kicked off 2022 by reporting top-line results from the second human abuse potential or HAP study, which I will recap shortly. We intend to generate REL-1017 clinical data readout beginning midyear for the ongoing RELIANCE phase III trial. We anticipate completing the enrollment of RELIANCE III, the ongoing monotherapy registrational phase III trial, followed by top-line data readout by mid-2022. In the third and fourth quarter of this year, we expect top-line results from RELIANCE I and RELIANCE II, respectively. These are two ongoing phase III sister two-arm placebo-controlled pivotal studies evaluating REL-1017 as a potential adjunctive treatment for MDD. The goal of this comprehensive development program is to address the significant need for a new therapeutic option to the 17 million individuals in the U.S. who suffer from MDD. The current antidepressant therapies have significant limitations in terms of efficacy. They can take up to four-six weeks to show any effect. Up to 65% of patients do not respond to their frontline antidepressant treatment, and up to 40% of patients take combination therapy. Furthermore, there are only three FDA-approved adjunctive treatment for MDD, all of which are antipsychotic, which offer limited efficacy and can cause long-term side effects. It is evident the new treatment options are needed, and we believe REL-1017 has the potential to be a safe and effective option for these patients and their caregivers as a monotherapy and adjunctive treatment. We made significant progress in advancing our development program. To this end, in February, we reported positive top-line data from our second HAP study, which compare REL-1017 versus intravenous ketamine. As a reminder, our first HAP study comparing REL-1017 versus oxycodone was completed in July 2021 and presented in a poster presentation late last year at the 60th annual meeting of the American College of Neuropsychopharmacology. Both studies were designed in accordance with the FDA 2017 abuse potential guidance and the 2020 and 2022 clinical and regulatory standards by incorporating extensive input from FDA staff on the measures and the comparators on trial design. While we went into extensive detail during our February investor call on the ketamine HAP study results, I would like to recap just the main findings. The primary endpoint, as is typical in these studies, was a drug liking score comparison of three doses of REL-1017 to ketamine. Ketamine dose at 0.5 milligrams per kilogram intravenously administered over 40 minutes. The three doses of REL-1017 were the same as in the oxycodone study that we presented last year. They were the 25 milligrams, the therapeutic dose, the 75 milligrams, which is three times the therapeutic dose, and 150 milligrams, which is six times the therapeutic dose and is the maximum tolerated dose. 51 subjects completed all arms of the study. The FDA guidance on abuse potential trials details that the statistical analysis should be based on data from participants who complete the study, the all completer population. Data based on the all completer population for both of the HAP studies showed a statistically significant difference from ketamine and oxycodone on all tested doses of REL-1017, and they were statistically equivalent to placebo at all tested doses of REL-1017. In summary, the finding of these two HAP studies are consistent with the 2019 DEA statement on methadone that states that the D isomer lacks significant respiratory depressant action and addiction liability. The results of the oxycodone and ketamine HAP study also confirm and support the previous data published regarding the potential for abuse of REL-1017. We believe that the oxycodone comparative data significantly de-risks any Schedule II potential for REL-1017, and that the ketamine comparison data significant de-risks the drug Schedule III potential. Collectively, the data generated today from our REL-1017 program indicates that REL-1017 could be proposed as a Schedule V drug and eventually non-scheduled following one or two years of market experience. In order to support the regulatory potential regulatory submission seeking approval for REL-1017 as a monotherapy as well as adjunctive treatment, the FDA confirmed that based on what is known at this time, Relmada will not be required to conduct the two-year carcinogenicity study of REL-1017 with an understanding that sufficient preclinical safety data have been generated to date. The FDA also confirmed that Relmada does not need to conduct a TQT cardiac study in humans to support cardio safety in a potential regulatory submission for REL-1017. The data provided to date, as well as the data to be generated from the ongoing phase III program, would be adequate to evaluate and confirm the cardio safety of REL-1017. Moving on to the phase III program, we anticipate the completion of enrollment of RELIANCE III, the ongoing monotherapy registrational phase III trial, followed by a top-line data readout by media. RELIANCE III aims to randomize up to 364 patients and is targeted for individuals who are diagnosed with depression and are currently taking standard antidepressant therapy. Importantly, this is prior to the anticipated conclusion of RELIANCE I and RELIANCE II, the adjunctive MDD studies, which I will discuss momentarily. As a reminder, conducting RELIANCE III as a phase III study could meaningfully reduce the time for a potential approval of REL-1017 as a MDD monotherapy. Let me now provide an update on the ongoing RELIANCE I and RELIANCE II studies, each of which is designed to include up to 364 participants per study across 55 study sites per study. As a reminder, RELIANCE I and RELIANCE II are designed to evaluate REL-1017 as an adjunctive treatment for MDD, and both include two arms, placebo and 25 milligrams of REL-1017. Both arms are studying the use of REL-1017 in addition to a standard antidepressant for participants who have had inadequate response to at least one and up to three standard antidepressant therapies. The primary endpoint is the change in MADRS score at day 28. Key secondary endpoints include the change in MADRS score at day seven and change in Clinical Global Impression Severity Scale, the CGI-S score at day 28. Day 28 was chosen as the primary endpoint in agreement with the FDA, with an understanding that depression is a chronic disease and that day 28 would support REL-1017 as a chronic treatment. Both RELIANCE I and RELIANCE II are progressing with top-line data expected in the second half of this year. The RELIANCE development programs also includes the RELIANCE OLS, a long-term open-label safety study that is enrolling both rollover participants for all three pivotal studies as well as de novo participants. RELIANCE OLS is ongoing and enrolling participants as planned. Data from this long-term open-label safety study will be part of the planned NDA filing package. I would also like to add that the recent pre-planned interim safety analysis conducted on a periodic basis by an independent data monitoring committee, the IDMC, confirmed the lack of safety signals and concluded with the recommendation for the studies to proceed as planned. These analyses reviewed data from all of the ongoing RELIANCE trials, including the open-label safety study. I would like to highlight that the phase II data we are publishing in the peer-reviewed American Journal of Psychiatry. That's the most widely read psychiatry journal in the world, late in 2021. The manuscript details the findings from the phase II study assessing REL-1017 as adjunctive treatment for MDD. The primary endpoint demonstrated the rapid, significant, and sustained efficacy of REL-1017 versus placebo. As our robust REL-1017 development program continues to advance expeditiously, we continue to be supported by a strong balance sheet, which was further enhanced by the successful oversubscribed follow-on offering that closed in the fourth quarter of last year and generated gross proceeds of $172.5 million. With that, I will now turn the call to Maged for review of the financials, including further details on the completed public offering. Maged, the stage is yours. Sure. Thank you, Sergio, and good afternoon, everyone. Today, we issued a press release announcing our business and financial results for the three months and twelve months ended December 31, 2021, which I will now review. For the fourth quarter ended December 31, 2021, total research and development expense was approximately $25.3 million as compared to $14.9 million for the comparable period of 2020. The increase was primarily related to an increase in costs associated with the execution of a broader clinical program for REL-1017. Research and development expense for the most recently completed fourth quarter included a non-cash charge of $1.5 million related to stock-based compensation expense. We also ended the fourth quarter of 2021 with a prepaid R&D expense balance of $8.6 million related to advanced payments to our CRO. Total general and administrative expense for the fourth quarter ended December 31, 2021, was approximately $8.9 million, as compared to $6 million for the comparable period of 2020. The increase was primarily due to increase in personnel costs, stock-based compensation, and consulting services. The non-cash charge related to stock-based compensation expense included in general and administrative expense totaled approximately $6.6 million in the most recently completed fourth quarter. For the fourth quarter ended December 31, 2021, we recorded a net loss of approximately $34.4 million, or $1.80 per basic and diluted share, compared to a net loss of $20.8 million, or $1.30 per basic and diluted share for the comparable period of 2020. For the year ended December 31, 2021, total research and development expense was approximately $90.6 million as compared to $36 million for the comparable period of 2020. The increase was primarily related to an increase in costs associated with the execution of a broader clinical program for REL-1017. Research and development expense for the year included a non-cash charge of $15.9 million related to stock-based compensation expense, which included the novel psilocybin one-time acquisition payment of $10.2 million to Arbormentis LLC in the third quarter of 2021. There was also a one-time cash payment of $2.5 million related to this acquisition. Total general and administrative expense for the year ended December 31, 2021, was approximately $35.1 million as compared to $24.9 million for the comparable period in 2020. The increase was primarily due to an increase in personnel costs, stock-based compensation, and consulting services. The non-cash charge related to stock-based compensation expense included in general and administrative expense totaled approximately $24.7 million for 2021. For the year ended December 31, 2021, we recorded a net loss of approximately $125.8 million or $7.16 per basic and diluted share, compared to a net loss of $59.5 million or $3.81 per basic and diluted share in the comparable period of 2020. On December 31, 2021, the company had cash and cash equivalents and short-term investments of $211.9 million, which compares with $117.1 million on December 31, 2020. This includes $161.2 million in net proceeds from the public offering closed in December 2021, through which we sold 10.1 million shares of our common stock at $17 per share. I will now ask the operator to please open the call for questions. Operator? Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Thank you. Our first question comes from Andrew Tsai with Jefferies. Please proceed with your question. Okay, thanks everyone, and good afternoon. Just curious on the DMC safety committee disclosure, which is routine. I'm curious if there were any kind of AEs of special interest that they were looking for. I mean, can you confirm if they were looking for withdrawals, dependence, addiction, euphoria, and so forth, were they looked at in this, blinded review? Thanks. Well, thank you, Andrew. I was sure you would have picked it up. Look, the committee is totally independent, so they only communicate to us if there is anything that would be of any worry in terms of safety. That includes anything, and I do believe includes withdrawals, in terms of anything it would be out of the normal course or out of the ordinary. We haven't heard anything. We got just a very simple and brief communications that the trial can continue as planned. That was it. There was nothing that would be of any worry. To be honest, Andrew, we have seen and you have seen a lot of data over the last few years, and there's been no signal that safety, it's, you know, it would be of any real big worry. We're always worried about everything, but safety is probably not what we are worried the most. Right. Okay. Hope I answered your question. Of course. That's great color. Then, I'll try to ask this one. It's just, I'm wondering if you can give us a flavor of what we can expect to see in the top line release in mid-2022 for RELIANCE III. Presumably, we'll see day seven, day 28 efficacy, AE rates. Will we see curves? Will we see response rates, remission rates, and so forth? Have you thought about what you plan to disclose? Thanks. Well, yes. Look, we'll disclose everything that we will receive from the statistical group that run the statistical analysis. With the caveat that clearly, you know, we want to leave details for the presentation publications. In terms of top line, we usually receive the primary and secondary endpoints. I don't know if we would receive the curves or not. We tend to be very quick. We don't want to hold the data for too long inside the company. You know, whenever we have something that is material, we tend to do it very quickly in a day or two. Yeah. It's a way to tell you that it depends on what we receive from the statistical group. Definitely primary and secondary endpoints. Great. All right. Thank you. Thank you, Andrew. Thank you. Our next question comes from Andrea Tan with Goldman Sachs. Please proceed with your question. Hey, everyone. Thanks for taking my question. Maybe sticking on with the monotherapy study, Sergio. Just curious if you could help frame expectations ahead of this study and what you've seen specifically from your prior studies that gives you confidence in REL-1017 demonstrating a benefit here as a monotherapy. And then I have a follow-up. Thanks. Yeah. Well, good afternoon, Andrea, and thanks for your question. Look, what we kind of, you know, can be applied to the monotherapy is clearly the, you know, the lack of any potential for abuse that we have seen and the safety. That's pretty common to all the studies. What we don't have is any data on efficacy as a monotherapy. We do have, you know, very strong efficacy data for the adjunctive therapy, but not as a monotherapy. That's what really it would be the most interesting data point. You know, there is not much else that we can apply or infer from phase II into the monotherapy data. We can kind of, I don't know, speculate that patients that failed one or two or three previous antidepressant, they are not completely different from patients that have not failed any previous antidepressant. We don't see a major differences between the two patient population. Yeah, we'll be very anxious to see these efficacy results as a monotherapy as well. Got it. Is there anything that can be inferred or will there be any read-through from the monotherapy results to the adjunctive pivotal studies here? Well, that's a very difficult question to answer. Look, if the study is successful as a monotherapy, then you know, we could infer just because we already have data as an adjunctive treatment positive, so we can infer that probably there is some indication of efficacy across all the patient population, across all the adjunctive and monotherapy population. If it doesn't go the way that we hope and we believe, then it's you know, it's more speculative, right? If it let's say it fails as monotherapy, but we have positive phase II as an adjunctive. I would say, I tend to say that if the study in monotherapy is not positive, I would not read too much into the adjunctive. If you want to go a little bit more in detail, what we don't know if there is any role of the inadequate response to the underlying antidepressant therapy as an adjunctive. We don't know if there is any synergistic effect between a non-effective SSRI or SNRI and an NMDA channel blocker. That's what we've learned from, you know, the monotherapy and the adjunctive therapy trial. Okay. There's a lot of speculation, so it's we really Mm-hmm. Mm-hmm. We want to see the data and then we can be more, like, accurate and realistic. Got it. Maybe just one last question. Just given that you are looking to include data from RELIANCE OLS in your filing package, could you just remind us on the timeframe there for the amount of follow-up and when you think you might have a completion for that portion? Well, we have a rolling NDA, so we will start to file, you know, the modules like the preclinical and the CMC well in advance of when we have the, you know, the clinical data. The goal is. It takes about six months, realistically. It's big, right, potentially for two indications and there's a new chemical entity, so it's a big NDA. We calculate six months as a fair time to do it correctly. You know what happens when you don't do it correctly. That's not a situation that we want to find ourselves. You know, if everything goes according to the plan, we should be able to complete the NDA by mid-2023. Perfect. Thanks, Sergio. Thank you, Andrea. Thank you. Our next question comes from Joon Lee with Truist Securities. Please proceed with your question. Hi. Thanks for taking our questions and congrats on all the progress. Now that you have completed two successful human abuse potential studies, has your outlook changed on possibly looking towards ex-U.S. opportunities in regions where they have maybe stricter, substance abuse laws? I believe China may have been one of them. Do you have any plans to enter the EU at some point? I have a follow-up. Well, thank you, Joon. It's a bit too early and look, we are extremely like busy and committed to the U.S. phase III program. In terms of, you know, areas where there is more sensitivity to like substance abuse or, you know, Japan is the one that's the most sensitive. Europe, we had, you know, few interactions with the EMA, with the, you know, the European FDA and there was no specific mention of specific interest in the abuse potential of the drug. With that said, there were preliminary conversations, so I don't know if it was the right time for, you know, the regulators to go deeper in that, in these aspects. You know, we will do something. You know, we will look into that, but a little bit later on. We like, we really would like the phase III program correctly and to do it right. That's the real focus. Okay. Sure. Great. In addition to the phase IIa data that you published in American Journal of Psychiatry, you know, you also published data showing rapid rise in BDNF after, you know, in human subjects dosed with methadone. Can you elaborate on the significance of that? You know, what do you plan to do with that information? Are you following that up with any other studies? Thank you. Yeah, it is a great question. Well, what we have done already, we have used these data. They were, you know, this is new data and to strengthen the IP. We put the BDNF data and the neuroplastic effect into a patent filed in 2018 that is under review. The clear indication is that mechanistically an NMDA channel blocker, they are very different from anything that is like SSRI, SNRI, like the traditional mechanism of action. It would indicate clearly that scientific and mechanistically there is a neuroplastic effect with an increase in functionality and increase in, you know, the proliferation of dendrite connection between nerve cells. That happened very quickly. This, you know, BDNF, brain-derived neurotrophic factor, is a growth factor. There should be some correlation between the BDNF increase and the neuroplastic effect. Just to be clear, Joon, the FDA does not consider BDNF as a surrogate for, you know, clinical efficacy in depression. We won't use it with the FDA and say, "Oh, increase the BDNF and there is efficacy." That's not gonna fly. But you know, clearly for IP it's very, very interesting. It's been confirmed by the extended and sustained effect of the drug after, you know, the therapy is stopped. At least for one week after interruption of the treatment, you still see a very nice and prolonged and sustained antidepressant effect. The clinical result, they match very, very clearly the scientific and mechanistic expectation. We will continue eventually for other indication to try to understand better and to leverage, you know, this potential for neuroplastic effect of the drug. Great. It's really important data. Very important data. Yes. If I could follow with one quick question. When you do complete enrollment in the monotherapy study, would you disclose completion of enrollment? Yeah, we probably will. Usually, companies usually do, and we don't want to be, you know, different from anybody else in this aspect. We'll probably do. All right. Looking forward to the data. Yeah, a few weeks. You know, the statisticians usually take a very wide range of timing when, you know, when they lock the database and when they provide the top line. They usually tell us, like, two-four weeks. That is. Okay. You know, for satisfaction is a narrow range for us, a little bit less narrow. You assume that when we complete the enrollment, you know, around, probably around a month, we will have the top data, top-line data. Sounds good. Thank you. Thank you, Joon Lee. Thank you. Our next question comes from Yatin Suneja with Guggenheim. Please proceed with your question. Hey, guys. Thank you for taking my question. A couple questions from me. Can you talk about what you might be seeing on the rate, what assumptions you have how many are. Sorry, Yatin, you broke up. Can you just talk about the discontinuation rate, what you might have assumed in the study and how it might be trending? How is the conversion from randomized to the open label? Yes, we can. I don't know how specific I should be before Maged shut me down, but the dropout rate is significantly not statistically, right? You know, it's very much lower than what we assume. We look at historical, and we discussed with the CRO that has a lot of experience in running depression studies. We assume mid-double digits, so around 15% in the statistical plan to be sure that we reach a number of patients that can be evaluated that is high enough for the power of the study. What we have seen so far across the board is much lower than that. I would say, you know, low to mid single digits. According to the CRO, that's not been seen before in depression study. Now, I'd like to be always direct and open. What we can read through that is like in safety, compliance, tolerability, it should not. That doesn't look to be an issue. I would not, you know, make the big step on reading anything into efficacy because half of the patients are taking placebo. Got it. In terms of the rollover, that's also a number that it's very good number. About three out of four patients, they accept, and they're happy to continue from the 20 days to rollover into the long-term safety. That's much higher than the average for this kind of study. Yeah. Got it. Again- That's helpful. You know, safety. Yeah, I know. Tolerability and acceptance and compliance, they look very good. Got it. Very helpful. One more question. I think one of the pushback or the things that we generally discuss with investor is the performance of the placebo arm in phase II. Can you just talk about how much cushion we might have in the phase III studies, how you might be controlling it? Any reason to believe that the monotherapy placebo rate might be different than the adjunctive one? Just give us some comfort and color around it. Yeah, I can give you, I can share what is, you know, what we discuss on a daily basis. We are fully aware that, you know, placebo effect is, you know, and that is strictly related with the quality of the patient population, meaning, you know, the patient should be a depressed patient that to enter the study. For the phase II, I do remember the delta from baseline to day seven for the placebo was around eight or nine points. That's a little bit lower than what has been seen historically, slightly lower. There is one point. The study was seven days on placebo. Placebo effect tends to increase over time. Seven days to have a placebo delta from baseline of eight or nine points at day seven is not unusual. It's actually even on the high side. We have seen placebo effect of four, five, six points in other studies at day seven. There is really nothing unusual there. It is something unusual is slightly higher. That was also expected because in clinic studies, they tend to have a higher placebo effect than outpatient studies. The second part of your question, what we are doing to try to minimize as much as possible the placebo effect. Well, you know, there is no magic, no secret that we use that nobody else has used. But we try to put together all the experience. Dr. Fava is the principal investigator, has published a lot about, you know, the potential for placebo effect. He's kind of an expert on, I would say on, you know, trying to control as much as possible unusual placebo response. With that said, there is a, you know, tidbits here and there. Like, there is a statement that the patient is reading before he's administered the MADRS every time that states that the, you know, he has 50% chance to take placebo. You know, the nurses are trained not to make comments about, you know, the patient looking good or better that could, you know, alter the response of the patient. All these, they together they can make some difference. We do believe that what really makes a difference at the end of the day is the quality and, you know, to be sure that the patient enrolled is a patient affected by, you know, MDD, by major depression. To do that, we use as a strategy, development strategy, what we have used in phase II, that is the SAFER questionnaire. The patient is re-diagnosed using a different diagnostic tool that is the SAFER questionnaire before it gets randomized. It can meet all the inclusion criteria based on the size and the MADRS scale before it gets randomized. Before it gets randomized, it goes to another, it's a phone call, so it's not a long process or. It goes to another, you know, diagnosed, but using the SAFER questionnaire. According to everybody that, you know, we have consulted, that is the best way possible to control placebo because it's, you know, it reduce the percent of patients that should not belong or should not be enrolled in this kind of study because they're not patient affected by depression. It was a long answer, but I wanted to be specific. Got it. Thank you so much. Thank you, Yatin. As a reminder, if you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. Our next question comes from Jay Olson with Oppenheimer. Please proceed with your question. Oh, hey, thanks for taking the question. Can you remind us how the human abuse study results compare to SPRAVATO? Would the human abuse data appear in the FDA-approved label so they could be used for promotional purposes? Thank you, Jay. Good afternoon. Well, the first question, how the comparison with ketamine of REL-1017 compare with SPRAVATO, they are totally different. Esketamine, it is low dose ketamine. It's the isomer of racemic ketamine but works exactly the same as racemic ketamine, according to all the literature. So the J&J run the study because probably was asked by the FDA, but clearly the expectation was not that esketamine is less potentially abusable than racemic ketamine is exactly what happened. You have seen the data of REL-1017, right? There are I don't know how many zeros after the period in terms of P value compared to ketamine. So, you know, the data are completely different. If the abuse data, the non-abuse data or the lack of abuse, meaningful abuse potential data for REL-1017 will be on the label can be used promotional. Well, you know, the straight answer that the FDA will decide. We like, we won't emphasize much about the lack of abuse potential of REL-1017 as a promotional tool. It's, you know, efficacy, rapid acting, sustained efficacy, they are a lot more powerful. With this data, I mean, I don't think anybody would think that there is any risk of abuse. At the time of potential approval, it probably, you know, people, I assume, won't be the focus of the attention of the clinician. Personally, if you ask me directly, maybe some centers that mimic what the DEA has already published in 2019, that the isomer lack abuse potential and a risk of respiratory depression. That's what I could speculate that could be in the label, mimicking the DEA statement. Okay, great. Thank you. Maybe as a follow-up, can you talk about any findings from your market research as you test the REL-1017 profile with prescribers, as you plan for your commercial launch, and especially if you have any feedback from payers in the U.S.? If you are considering a partner ex-U.S.? Thank you. Yes. We did, you know, that it's never too early to discuss with the payer, so we keep, you know, everybody that is in the chain as updated as possible. From my experience, the payer really consider seriously, right, to get into a conversation when they have phase III data. You know, before data from their perspective, they legally tell you, "Show me the data and then we can discuss." Like really top-down and, you know, the monotherapy, it's a bit more challenging in terms of, you know, reimbursement and depending on the price because, you know, the frontline therapy that is currently proposed supported by the payers is generic SSRI. They works a little bit and they are relatively safe and they're extremely inexpensive. That's a little bit of a hard go to overcome as a monotherapy. Adjunctive, there is no antidepressant approved. That would be a great. It's gonna be very difficult to have an adjunctive treatment where there's no competition in terms of antidepressant and that works fast and hopefully we don't believe it will be priced at the esketamine or at esketamine range, would be potentially affordable by the by a mass market patient population. That one we don't believe is going to be a major challenge to get reimbursement and you know as a as a as a I don't know how to call it but as a frontline adjunctive treatment. With that said, going back for a second to monotherapy, if the data in phase III will be any close to the phase II data that we have seen in monotherapy, meaning the monotherapy will mimic somewhat the adjunctive phase II data. It's going to be difficult for the payers, you know, not to reimburse a drug that works much faster. There is pharmacoeconomic data too, right? That if you can, you know, get out of your depression status quicker, you are more productive. That's more European, but I do believe the U.S. also focus on this aspect too, right? The pharmacoeconomic. If you can improve and go to work a lot faster than if you take an SSRI, that's probably is a lot more value than, you know, to save some reimbursement or some payers money, using, you know, starting with an SSRI. If you have a rapid acting and a sustained efficacy drug, it's gonna be difficult not to reimburse it, even as a monotherapy. You know, the key will be clinical data. Okay, great. Any plans to sign an ex-US commercial partner? Well, yeah, always in this kind of situation, pre-phase III data, there is always some conversation in there, but we don't believe that nothing will happen. We are too close to phase III data. Nobody will sign an agreement or paying like a the adequate price, you know, a few months before phase III data. Straight answer is, yeah, not before phase III data. We don't expect anything happening outside the U.S. before phase III data. We also would like to retain, you know, the global rights that is like there is a value in having the global rights. Okay, got it. Especially after phase III. Thank you. Finish Thank you. Finish the question. Thank you, Jay. Thank you. There are no further questions at this time. I'd like to turn the call back over to Sergio Traversa for any final remarks. Thank you. Thank you, operator. Well, thank you very much everyone on the call for the interest, the time and the interest in our program. I would like to thank also you know, the Relmada team for the effort and the energy they're putting in this program and the clinicians and the patients that are really helping to complete this ambitious but realistic program to you know, offer patients a good or better solution to treat depression. With that said, I wish everyone a wonderful rest of the day. Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.