Relmada Therapeutics Inc (RLMD) 2021 Q4 法說會逐字稿

Greetings, and welcome to the Relmada Therapeutics Fourth Quarter and Full Year 2021 Earnings Call. (Operator Instructions) 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 3 and 12 months ended December 31, 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 30, 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 23, 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'd like to turn the call over to Sergio. Sergio?

Thank you, Tim, as always, and good afternoon to everyone. I'm pleased to welcome 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 time line 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 will then take your questions.

Looking ahead, we expect 2022 to be a catalyst-rich 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 mid-year 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 midyear 2022.

In the third and fourth quarter of this year, we expect top line results from RELIANCE I and RELIANCE II, respectively. These are 2 ongoing Phase III sister, 2-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, and they can take up to 4 to 6 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 3 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 that 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 compared REL-1017 versus intravenous keta. 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 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 3 doses of REL-1017 to ketamine. Ketamine dosed at 0.5 milligrams per kilograms intravenous administered over 40 minutes. The 3 doses of REL-1017 were the same as in the oxycodone study that we presented last year. And they were the 25-milligram therapeutic dose; the 75 milligrams, which is 3x the therapeutic dose; and 150 milligrams, which is 6x 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 completed population. Data based on the all completed 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 2 HAP studies are consistent with the 2019 DEA statement on esmethadone that states that the d-isomer lacks significant respiratory depressant action and addiction liability. The results of the oxycodone and ketamine HAP study also confirmed and support the previous data published regarding the potential for abuse of REL-1017.

We believe that the oxycodone comparative data significantly derisks the Schedule II potential for REL-1017 and that the ketamine comparison data significant derisks 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 nonscheduled following 1 or 2 years of market expedience.

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 2-years carcinogenicity study of REL-1017, with an understanding that sufficient preclinical safety data have been generated today.

The FDA also confirmed that Relmada does not need to conduct the TQT cardiac study in human to support cardiac 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 cardiac 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 top line data readout by mid-year. 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 an 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 into 2 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 had -- have had inadequate response to at least 1 and up to 3 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 7 and change in Clinical Global Impressions-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 will support REL-1017 as a chronic treatment. Both RELIANCE I and the RELIANCE II are progressing, with top line data expected in the second half of this year.

The RELIANCE development programs also include the RELIANCE-OLS, the long-term open-label safety study that is enrolling both rollover participants for all 3 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. This analysis 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 were published in the peer-reviewed American Journal of Psychiatry, that's the most widely read psychiatry journal in the world, late in 2021. The manuscript further details finding that from the Phase II study assessing REL-1017 as adjunctive treatment for MDD. The primary endpoint demonstrated the rapid, significant and sustained efficacy versus placebo REL-1017.

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 turn now the call to Maged for a 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 3 months and 12 months ended December 31, 2021, which I'll 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 noncash 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 advance 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 noncash 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 noncash charge of $15.9 million related to stock-based compensation expense, which included the novel psilocybin onetime acquisition payment of $10.2 million to Arbormentis in the third quarter of 2021. There was also a onetime 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 noncash 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?

(Operator Instructions) Thank you. Our first question comes from Andrew Tsai with Jefferies.

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?

Thank you, Andrew. I was sure you would pick it up. The committee is totally independent. So they only communicate to us if there is anything that would be of any worried in terms of safety that includes anything. And I do believe it includes withdrawal symptoms or anything that would be out of the normal course, out of the ordinary. We haven't heard anything. We've got a very, very simple and brief communications that the trial can continue as planned. That was it. So there was nothing that would be of any worry.

But 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 -- it would be of any real big worry. I mean we're always worried about everything, but safety is probably not what we are worried the most. I hope I answered your question.

Okay. Of course, that's great color. And then I'll try to ask this one is 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 7, day 20 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?

Well, yes. Look, we will disclose everything that we will receive from the statistical group that runs the statistical analysis, with a caveat that clearly, we want to leave details for the presentation publications. But in terms of top line, we -- usually, we receive the primary and secondary endpoints.

I don't know if we would -- we will 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. So whenever we have something that is material, we tend to do it very, very quickly, in a day or 2. So it's a way to tell you that it depends on what we receive from the statistical group, definitely primary and secondary endpoints.

Our next question comes from Andrea Tan with Goldman Sachs.

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.

Yes. Well, Andrea, thanks for your question. Well, we -- what kind of can be applied to the monotherapy is clearly the lack of any potential for abuse that we had seen and the safety. That's pretty common to all the studies. What we don't have is any -- based on efficacy as a monotherapy. We do have very strong efficacy data for the adjunctive therapy, but not as a monotherapy. So that's what really -- it would be the most interesting data point. And there is not much else that we can apply or infer in the -- from Phase II into the monotherapy data.

We can kind of, I don't know, speculate that patients that failed 1 or 2 or 3 previous antidepressants, they are not completely different from patients that have not failed any previous antidepressants. So we don't see a major difference between the 2 patient population. But yes, we'll be very anxious to see these efficacy results as a monotherapy as well.

Got it. And then 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. But -- if the study is successful in -- as a monotherapy, then 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 in -- across all the patient population, for all the adjunctive and monotherapy population.

If it doesn't go the way that we hope and we believe, then it's -- it gets more speculative, right? If it -- let's say, it fails as a monotherapy, but we have positive Phase II as an adjunctive, so I would say -- I'm planning to say that if this study in monotherapy is not positive, I would not read through much into the adjunctive. And I 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 adjunct. We don't know if there is any synergistic effect between a noneffective SSRI or SNRI and an NMDA channel blocker. That's what we learned from the monotherapy and the adjunctive therapy trial. There's a lot of speculation. So we want to see the data, and then we can be more like accurate and realistic.

Got it. And then 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 time frame 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 the models like the preclinical and the PMC well in advance than when we have the clinical data. The goal is to -- it takes about 6 months realistically. It's a big, right, potentially for 2 indications, and there's a new chemical entity. So it's a big NDA. And so we calculate 6 months as a fair time to do it correctly. And you know what happened when they don't do it correctly. That's not a situation that we want to find ourselves. So if everything goes about -- according to the plan, we should be able to complete the NDA by mid-2023.

Our next question comes from Joon Lee with Truist Securities.

Congrats on all the progress. So now that you have completed 2 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. And do you have any plans to enter the U.S. -- enter the EU at some point? And I have a follow-up.

Thank you, Joon. The -- it's a bit too early. And look, we are extremely busy and committed to the U.S. Phase III program. In terms of areas where there is more sensitivity to like substance abuse or -- Japan is the one that's the most sensitive. Europe, we had a few interactions with the EMA, with the European FDA. And there was no specific mention or 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 the regulators to go deeper in that -- in these aspects. So we will do something. We will look into that, but a little bit later on. We really would like the Phase III program correctly and to do it right. That's the real focus.

Okay, sure. Great. And then in addition to the Phase IIa data that you published in American Journal of Psychiatry, you also published data showing rapid rise in BDNF after -- in human subjects dosed with esmethadone. So can you elaborate on the significance of that? And what do you plan to do with that information? Are you following that up with any other studies?

Yes, that's a great question. Well, what we have done already, we have used these data -- we're working on this new data and -- to strengthen the IP. So we put the BDNF data and the neuroplastic effect into a patent filed in 2018 that is under review. And well, what -- 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. And it would indicate clearly that scientific and mechanistically, there is a neuroplastic effect.

We did an increase in functionality and increase in the proliferation of dendrite connection between nerve cells, and that's happened very quickly. And this BDNF, brain-derived neurotrophic factor, is a growth factor. So 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 clinical efficacy in depression. So we won't use it with the FDA, saying increase the BDNF and there is efficacy. That's not going to fly.

And -- but clearly, for IP, it's very interesting. It's been confirmed by the extended and sustained effect of the drug after the therapy is stopped. So at least for 1 week after interruption of the treatment, you still see a very nice and prolonged and sustained antidepressant effect. So the clinical result, they match very, very clearly, the scientific and mechanistic expectation. So -- I mean we will continue eventually for other indications to try to understand better and to leverage this potential for neuroplastic effect of the drug. So very important data.

Yes. And then if I could follow up with one quick question. When you do complete enrollment in the monotherapy study, would you disclose completion of enrollment?

Yes, we probably will. Usually, companies usually do, and we don't want to be different from anybody else in these aspects. And so we'll probably do. We assume a few weeks -- yes, a few weeks. The starting station, usually they take a very wide range of timing when they lock the database and when they provide the top line. They usually tell us like 2 to 4 weeks. That is -- yes, for starting station, is a narrow range. For us, a little bit less narrow. But -- so you assume that when we complete enrollment around -- probably around the months, we will have the top line data.

Our next question comes from Yatin Suneja with Guggenheim.

A couple of questions from me. Can you talk about what you might be seeing on the discontinuation rate? What assumptions you might (technical difficulty).

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 shuts me down. But the dropout rate is significantly -- not statistically, right, but it's very much lower than what we assumed. We look at historical and we discuss with the CRO that has a lot of experience in running depression studies. And we assume mid-double digits or around 15% in the statistical plan to be sure that we reach a number of patients that is -- that can be evaluated, it is high enough for the power of the study.

And what we have seen so far across the board, it's much lower than that. I would say, it's low to mid-single digits. So according to the CRO, that's not been seen before in depression study. Now I'd like to be always directed and open. What we can read through that is like safety, compliance, tolerability, it should not -- doesn't look to be an issue. I would not make the big step on reading anything into efficacy, because half of the patients are taking placebo.

In terms of rollover, that's also a number that the -- it's a very good number. So about 3 out of 4 patients, they accept and are happy to continue from the 28 days to roll over into the long-term safety. That's much higher than the average for this kind of study, yes.

Got it. That's helpful.

Safety, tolerability and acceptance and compliance, they look very good.

Got it. Got it. Very helpful. Then one more question. So I think one of the pushbacks are -- the things that we generally discuss with investor is the performance of the placebo arm in Phase II. So 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.

No, I can give you -- I can share what is -- what we discuss on a daily basis. We are fully aware that placebo effect is -- and that is strictly related with the quality of the patient population, meaning the patient should be a depressed patient that -- to enter the study. And the -- for the Phase II, I do remember the delta from baseline to day 7 for the placebo was around 8 or 9 points.

That's a little bit -- a bit lower than what has been seen historically, slightly lower. But there is one point, the study was 7 days on placebo. Placebo effect tends to increase over time. So 7 days to have a placebo delta from baseline of 8, 9 points at day 7 is not unusual. It's actually even on the high side.

We have seen placebo effect of 4, 5, 6 points in other studies at day 7. So there is really nothing unusual there. It is something -- unusual is slightly higher. That was also expected, because in, in-clinic studies, they tend to have a higher placebo effect than outpatient studies.

So the second part of your question, what we are doing to try to minimize as much as possible the placebo effect. But there is no magic, no secret that can be -- that we use, that nobody else has used, but we try to put together all the experience. And Dr. Fava is the principal investigator, has published a lot about the potential for placebo effect. And so he is kind of an expert on, I would say, trying to control as much as possible unusual placebo response.

With that said, there is tidbits here and there. Like there is a statement that the patient is reading before he is administered the MADRS scale every time that states that the -- he has 50% chances to take placebo. The nurses are praying not to make comments about the patient looking good or better that could alter the response of the patient. So all these -- they -- together, they can make some difference.

We do believe that what really makes the difference at the end of the day is the quality and to be sure that the patient enrolled is a patient is affected by MDD, by major depression. And to do that, we do -- we use as a strategy -- development strategy what we have used in Phase II that is the SAFER questionnaire. So the patient is rediagnosed using a different diagnostic tool that is the SAFER questionnaire before he gets randomized.

So it is -- it can meet all the inclusion criteria based on the sites and the MADRS scale before he gets randomized. But before he gets randomized, it goes to another -- it's a phone call. So it's not a very -- it's another long process. And it goes to another diagnosed, but using the SAFER questionnaire.

According to everybody that we have consulted, that is the best way possible to confirm placebo, because it reduced the percent of patients that should not be long or should not be enrolled in this kind of study because they're not patients affected by depression. That was a long answer, but I wanted to be specific.

(Operator Instructions) Our next question comes from Jay Olson with Oppenheimer.

Can you remind us how the human abuse study results compare to Spravato? And would the human abuse data appear in the FDA-approved label so they could be used for promotional purposes?

Thank you, Jay. Well, the first question, how the comparison with ketamine or REL-1017 compare with Spravato, they are totally different. Esketamine, it is a 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. It's exactly what happened. You have seen the data of REL-1017. I don't know how many zeros after the period in terms of p value compared to ketamine. So the data are completely different.

And 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, no. The straight answer is that the FDA will decide. We won't emphasize much about the lack of abuse potential of REL-1017 as a promotional tool. Its 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 over-abuse.

So at the time of potential approval, it probably -- people -- I assume won't be the focus of the attention of the clinician. So personally, if you ask me directly, maybe some centers that mimic what the DEA has already published in 2017 -- in '19 that the isomer lacked abuse potential and risk of respiratory depression. That's what I could speculate that could be in the label by mimicking the DEA statement.

Okay. Great. And 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.? And then if you are considering a partner ex U.S.?

Yes. So we did -- it's never too early to discuss with the payers. So we keep everybody that is in the chain as updated as possible. From my experience, the payers really consider seriously to get into a conversation when they have Phase III data. Before data, from their perspective, they will say show me the data and then we can discuss.

Like really top-down and is -- the monotherapy, it's a bit more challenging in terms of reimbursement and depending on the price, because the frontline therapy that is currently proposed, supported by the payers is generic SSRI. They work a little bit, and they are relatively safe, and they're extremely inexpensive. So that's a little bit of a hard, though, to overcome as a monotherapy.

Adjunctive, there is no antidepressant approved. So that would be a great -- it's going to be very difficult to have an adjunctive treatment where there's no competition in terms of antidepressant and that works fast. And hopefully -- I mean we don't believe it will be priced at the esketamine range, so would be potentially affordable by a mass market patient population. So that one, we don't believe, is going to be a major challenge to get reimbursement and is, I don't know how to call it, but is a frontline adjunctive treatment.

With that said, going back for a second to monotherapy, if you -- 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 not to reimburse the drug that works much faster. There is pharmacoeconomic data, too, right, that -- if you can get out or improve your depression status quicker, you are more productive.

That's more European, but I do believe the U.S. also focus on these aspects, too, right? And so the pharmacoeconomic. If you can improve and go to work a lot faster than if you take an SSRI, that's probably a lot more value than to save some reimbursement or some payers' money using -- starting with an SSRI. So if you have a rapid-acting and sustained efficacy drug, it's going to be difficult not to reimburse, even as a monotherapy. The key will be clinical data.

Okay. Great. And any plans to find an ex U.S. commercial partner?

Well, the -- as always in this kind of like situation pre-Phase III data, there's always some conversation here and 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 the adequate price a few months before Phase III data. So straight answer is not before Phase III data. We don't expect anything to happen outside the U.S. before Phase III data. We also would like to retain the global rights. That is -- there is a value in having the global rights, especially after Phase III.

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. And I would like to thank also 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 offer patients a good or better solution to treat depression.

With that said, 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.