Relmada Therapeutics, Inc. Q4 FY2021 Earnings Call

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. 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 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 the anticipated clinical trial readouts timeline for REL-1017, our lead product candidate, which 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 our 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 readouts beginning mid-year for the ongoing RELIANCE Phase 3 trial. We anticipate completing the enrollment of RELIANCE III, the ongoing monotherapy registrational Phase 3 trial, followed by a top line data readout by mid-year 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 3 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 three FDA-approved adjunctive treatments for MDD, all of which are antipsychotics, 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, both 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 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 2022 clinical and regulatory standards, incorporating extensive input from FDA staff on the measures and the comparators in 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 was dosed 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: the 25-milligram therapeutic dose, the 75 milligrams which is 3 times the therapeutic dose, and 150 milligrams which is 6 times the therapeutic dose and is the maximum tolerated dose. A total of 51 subjects completed all arms of the study. The FDA guidance on Abuse Potential Trial 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 on all tested doses of REL-1017. In summary, the findings of these two 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 confirm and support the previous data published regarding the potential for the 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 significantly derisks the drug's Schedule III potential. Collectively, the data generated to date 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 marketing. In order to support the potential regulatory submission seeking approval for REL-1017 as a monotherapy as well as an adjunctive treatment, the FDA confirmed that based on what is known at this time, Relmada will not be required to conduct a two-year carcinogenicity study of REL-1017 with the understanding that sufficient preclinical safety data has been generated to date. The FDA also confirmed that Relmada does not need to conduct the TQT cardiac study in humans 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 3 program, would be adequate to evaluate and confirm the cardiac safety of REL-1017. Moving on to the Phase 3 program, we anticipate the completion of enrollment of RELIANCE III, the ongoing monotherapy registrational Phase 3 trial, followed by a top line data readout by year-end. RELIANCE III aims to randomize up to 364 patients, targeted for individuals who are diagnosed with depression and are currently undergoing 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 3 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 each. 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 an 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 at day 7 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 the understanding that depression is a chronic disease and that day 28 will 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 include the RELIANCE-OLS, the 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 these long-term open-label safety studies 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 2 data were published in the peer-reviewed American Journal of Psychiatry, the most widely read psychiatry journal in the world late in 2021. The manuscript further details findings from the Phase 2 study assessing REL-1017 as adjunctive treatment for MDD. The primary endpoint demonstrated the rapid, significant, and sustained efficacy versus placebo for 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 now turn 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 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 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 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 the rise 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 one-time acquisition payment of $10.2 million to Arbormentis 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 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?

Our first question comes from Andrew Tsai with Jefferies.

Okay. Thanks, everyone, and good afternoon. Just curious on the DMC safety community 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, and so forth, were they looked at in this blinded review? Thank you.

Thank you, Andrew. I was sure you would have kicked it off. The committee is totally independent, so they only communicate to us if there is anything that would be any concern in terms of safety, which includes anything. And I do believe it includes withdrawal symptoms or anything that would be out of the ordinary. We haven’t heard anything. We received just a very, very simple and brief communication stating that the trial can continue as planned. That was it. So, there was nothing that would be of any concern. But to be honest, Andrew, we have seen a lot of data over the last few years, and there’s been no signal that safety would be of any real big concern. I mean, we’re always concerned about everything, but safety is probably not what we are worried the most. I hope I answered your question.

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 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 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 receive the primary and secondary endpoints. I don’t know if we will receive the curves or not. We tend to act very quickly. 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 announce it very, very quickly in a day or two. So, it’s a way to say that it depends on what we receive from the statistical group, but definitely the 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. Thanks.

Yes. Well, good afternoon, Andrea, and thanks for your question. So, what we can apply to the monotherapy is clearly 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 efficacy data as a monotherapy. We do have very strong efficacy data for the adjunctive therapy, but not as a monotherapy. So, that’s what really is going to be the most interesting data point. And there is not much else that we can apply or infer from the Phase 2 into the monotherapy data. We can speculate that patients who failed 1 or 2 or 3 previously used antidepressants are not completely different from patients who have not failed any previous antidepressant. So, we don’t see a major difference between the two patient populations. But yes, we’d be very anxious to see this efficacy result 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 for the adjunctive pivotal studies here?

That’s a challenging question to address. If the study proves successful as a standalone treatment, we may be able to draw some conclusions, especially since we already have positive data from adjunctive treatment. This suggests there could be some level of effectiveness for both groups of patients. If the results aren’t as favorable as we hope, we will have to treat it more cautiously. For instance, if it fails as a standalone treatment but we have encouraging Phase 2 results for adjunctive treatment, I would be hesitant to conclude much about the adjunctive outcomes if the monotherapy study is not positive. I want to provide more clarity on that. We are uncertain about the impact of inadequate responses to previous antidepressant therapies when used adjunctively. We also don’t know if there are any synergistic effects between a non-effective SSRI or SNRI and an NMDA channel blocker. These are insights we will gain from the trials focusing on both monotherapy and adjunctive therapy. There is considerable speculation right now, and we are eager to see the data to form more informed and realistic conclusions.

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?

We have a rolling NDA, so we will begin filing the modules, such as the preclinical and CMC, ahead of receiving the clinical data. The realistic expectation is that this process takes about six months. It’s a significant application for two indications and involves a new chemical entity, making it a major NDA. We believe that six months is a reasonable timeframe to ensure the process is handled correctly, as any mistakes could lead to undesirable situations. Assuming all goes according to plan, we aim to complete the NDA by mid-2023.

Our next question comes from Joon Lee with Truist Securities.

Hi. Thanks for taking our questions. And congrats on all the progress. So, 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? And do you have any plans to enter the EU at some point? And I have a follow-up.

Thank you, Joon. It’s a bit too early. And look, we are extremely busy and committed to the U.S. Phase 3 program. In terms of areas where there is more sensitivity to substance abuse, Japan is the one that is the most sensitive. Europe, we have had a few interactions with the EMA, European FDA. There was no specific mention or specific interest in the abuse potential of the drug. With that said, they were preliminary conversations. So, I don’t know if it was the right time for the regulators to dive deeper into these aspects. So, we will do something, we will look into it, but a little bit later on. We really would like to get the Phase 2 program correctly and to do it right. That’s the real focus.

Great. And then, in addition to the Phase 2a data that you published in the American Journal of Psychiatry, you also published data showing a rapid rise in BDNF in human subjects dosed with oxymethadone. 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 already done is used this data to strengthen the IP. We included the BDNF data and the neuroplastic effect in a patent filed in 2018 that is under review. The clear indication is that mechanistically, as an NMDA channel blocker, it is very different from anything that is like SSRIs and traditional mechanisms of action. It clearly indicates that scientifically and mechanistically, there is a neuroplastic effect. We did observe an increase in functionality and proliferation of dendritic connections between nerve cells, and that happened very quickly. And this BDNF, brain-derived neurotrophic factor, is a growth factor. So there should be some correlation between the increase in BDNF and the neuroplastic effect. Just to clarify, Joon, the FDA does not consider BDNF as a surrogate for clinical efficacy in depression. So, we won’t use it with the FDA's approval to say that an increase in BDNF equates to efficacy. That’s not going to work. However, for IP, it’s very interesting. It has been confirmed by the extended and sustained effect of the drug after therapy is stopped, so at least for one week after stopping treatment, we still see a very nice and prolonged antidepressant effect. So, the clinical results match very clearly with the scientific and mechanistic expectations. We will continue eventually for other indications to try to understand better and leverage this potential for the neuroplastic effect of the drug. This is 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. Companies typically do, and we want to align with that. So, we likely will. It will take a few weeks. The statistician generally provides a timeframe of about 2 to 4 weeks from when they lock the database to when they deliver the top line data, which is a short duration for them. For us, it may take a bit longer. However, you can expect that once we finish enrollment, we will have the top line data within a month.

Our next question comes from Yatin Suneja with Guggenheim.

A couple of questions for me. Can you talk about 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'm not sure how specific I can be before Maged stops me. However, the dropout rate is significantly lower than we initially assumed. We analyzed historical data and spoke with the CRO who has extensive experience in depression studies. We had anticipated a dropout rate in the mid-double digits, around 15%, as part of our statistical plan to ensure we had enough patients for evaluating the study's power. However, what we’ve observed so far is much lower, around the low to mid-single digits. According to the CRO, this dropout rate is unprecedented in a depression study. I want to be direct; what we’re seeing indicates that safety, compliance, and tolerability are not issues. I wouldn't draw strong conclusions about efficacy since half of the patients are receiving a placebo. Regarding rollover, the acceptance rate is also very good, with about 75% of patients willing to continue from the 28-day phase into long-term safety, which is above average for studies of this nature. Overall, safety, tolerability, acceptance, and compliance look very positive.

That’s helpful. Got it. Got it. Very helpful. Then, one more question. I think one of the pushbacks or the things that we generally discuss with investors is the performance of the placebo arm in Phase 2. So, can you just talk about how much cushion we might have in the Phase 3 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 share what we discuss on a daily basis. We are fully aware that placebo effect is - and that is strictly related to the quality of the patient population, meaning the patient should be a depressed patient that - to enter the study. For the Phase 2, I do remember the delta from baseline to day 7 for the placebo was around 8 or 9 points. That’s a little bit lower than what has been seen historically, slightly lower. But there is one point: the study was 7 days on placebo. Placebo effects tend to increase over time. So, 7 days to have a placebo delta from baseline of 8 or 9 points at day 7 is not unusual. It’s actually slightly on the high side. We have seen placebo effects of 4, 5, or 6 points in other studies at day 7, so there is really nothing unusual there. It is somewhat unusual because it’s slightly higher. That was also expected because in clinical studies, they tend to have a higher placebo effect than outpatient studies. So, the second part of your question is what we are doing to minimize the placebo effect as much as possible. Unfortunately, there is no magic, no secret that we use that nobody else has used, but we try to leverage all the experience. Dr. Fava is the principal investigator; he has published a lot about the potential for placebo effect. So, he is an expert in trying to control unusual placebo responses as much as possible. With that said, there are tidbits here and there, like there is a statement that the patient reads before being administered the MADRS scale every time, stating that he has a 50% chance of receiving a placebo. The nurses are trying not to make comments about the patient looking good or better, which could alter the patient's response. All these elements together can make some difference. We believe that what really makes the difference at the end of the day is the quality of the patients enrolled. To ensure the patient is affected by MDD, we use as a development strategy what we used in Phase 2, which is the safer questionnaire. So, the patient is re-diagnosed using a different diagnostic tool that is the safer questionnaire before being randomized. This is not a very long process; it’s another phone call. They go through a different diagnosis, but using the safer questionnaire. According to everyone we have consulted, that is the best way possible to confirm placebo, as it reduces the percentage of patients who should not be enrolled in this kind of study because they’re not affected by depression. That was a lengthy answer, but I wanted to be specific.

Our next question comes from Jay Olson with Oppenheimer.

Could 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. Good afternoon. Well, to answer the first question, the comparison of REL-1017 with ketamine to that of Spravato, they are entirely different. Esketamine is a low-dose ketamine, the isomer of racemic ketamine but functions exactly like racemic ketamine according to all the literature. So, Johnson & Johnson ran the study, likely at the behest of the FDA, but clearly, the expectation was not that esketamine is less potentially usable than racemic ketamine. It’s exactly what happened. You have seen the data of REL-1017. I don’t know how many zeros follow the decimal in terms of p-value compared to ketamine. So, the data are completely different. As for whether the non-abuse data will be included in the label and could be used for promotional purposes, the straightforward answer is that the FDA will decide. We won’t emphasize the lack of abuse potential of REL-1017 as a promotional tool. Its efficacy, rapid-acting, sustained efficacy carry a lot more weight. With this data, I mean, I don’t think anybody would think that there is any risk of abuse. So, at the time of potential approval, it probably wouldn’t be the focus of attention for clinicians. Personally, if you asked me directly, maybe some centers would draw parallels to what the FDA has already published in 2019, stating that the isomer lacked abuse potential and respiratory depression. That’s what I could hypothesize might be reflected in the label.

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 payors in the U.S.? And then, if you are considering a partner ex-U.S.?

Yes. So, it’s never too early to discuss with payors. We keep everyone in the chain updated as much as possible. From my experience, the payors only take the conversation seriously when they have Phase 3 data. Before that, from their perspective, they often say, 'Show me the data, then we can discuss.' It is very much top-down. In terms of the monotherapy, it becomes a bit more challenging regarding reimbursement, depending on the price, since the frontline therapy currently supported by payors is generic SSRIs. They work somewhat effectively, are relatively safe, and are extremely inexpensive. So, that poses a challenge to overcome in monotherapy. As for adjunctive treatment, there are no antidepressants approved, so that would be advantageous. It’s going to be very difficult to have an adjunctive treatment where there’s no competition regarding antidepressants, yet it works quickly. Hopefully, it won't be priced at the level of esketamine, making it potentially affordable for a mass market patient population. Thus, we do not believe it will pose a significant challenge in obtaining reimbursement as a frontline adjunctive treatment. With that said, returning to the monotherapy, if the Phase 3 data mirrors or is close to what we have seen in Phase 2, meaning the results are consistent with the adjunctive Phase 2 data, it becomes difficult for payors not to reimburse a drug that works much faster. There is also pharmacoeconomic data indicating that if you can improve a patient's depression status quicker, they become more productive. That tends to be more applicable in Europe, but I believe it is also considered by payors in the U.S. as well. So that pharmacoeconomic perspective certainly adds value; when faster improvement is observed compared to the slow reductions of SSRI treatment, it contributes to the overall argument for reimbursement. The key will ultimately be the clinical data. Well, as always, in this kind of situation pre-Phase 3 data, there are always conversations here and there, but we don't believe anything substantial will happen. We are too close to Phase 3 data, and nobody will sign an agreement or pay an adequate price just a few months before Phase 3 data. So, the straight answer is that we do not expect anything to happen outside the U.S. before Phase 3 data. We also would like to retain the global rights. There is inherent value in having those global rights.

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 your time and interest in our program. I would also like to thank the Relmada team for the effort and energy they have devoted to this program, and likewise the clinicians and the patients that are assisting in completing this ambitious but realistic program to offer patients a better solution for treating 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.