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spk09: Ladies and gentlemen, and thank you for standing by. Welcome to the Relmada Therapeutics Incorporated first quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. Should you require operator assistance during the conference, please press star zero to signal an operator. Please note, this conference is being recorded. I will now turn the conference over to your host, Tim McCarthy with Lifestyle Advisors.
spk01: Thank you, operator, and thank you all for joining us this afternoon. With me on today's call are Chief Executive Officer Dr. Sergio Traversa and Chief Accounting and Compliance Officer Chuck Ence. This afternoon, RealMata issued a news release providing a business update and announcing financial results for the first quarter ended March 31st, 2021. Please note that certain information discussed on the call today is covered under the safe harbor provision of the Private Security Litigation Reform Act. We caution listeners that during this call, RealMata'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 statements contained in RealMata's press release issued today and the company's SEC filings, including in the annual report on Form 10-K and subsequent filings. This conference call also contains time-sensitive information that is accurate only As of the date of this live broadcast, May 12th, 2021, RealMata 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?
spk05: Thank you, Tim. And good afternoon to everyone. I'd like to welcome you to RealMata's first quarter 2021 conference call. Today's call will provide ...on the comprehensive development program for the treatment of depression, the L1017, and the upcoming milestones. I will turn the call again to our chief officer, and we're standing today for our magazine for a review of the data. By the chief of recent data, that we presented at three recent scientific conferences. With that, I'll begin with an update on RELIANCE, that is the ongoing program that consists of a third one, placebo-controlled pivotal studies, RELIANCE I and RELIANCE II, which includes 64 participants per study of 45,000. Reliance OLS that stands for Long-Term Open Label Safety Study that is enrolled in both rollover participants from the PIVOT studies as well as the novo participants. These studies are designed to evaluate REL 1017 as an adjunctive treatment for major depressive disorder, MPD, and includes SMART. and 25 milligrams of REL-1017. I just got somebody told me that I'm breaking up, so I'll try to switch. Now it should be better. And I was saying placebo and 25 milligrams of REL-1017, and both are on top of standard antidepressant treatment for participants. We have already unsuccessfully tried a minimum of one up to three antidepressant therapy. The primary endpoint is change in Madras score at day 28. Key secondary endpoints include change in Madras score at day seven and change in CGIS, the stage four severity, at the score at day 28. The first phase three trial, Reliance One, continues to enroll as expected, and additional sites are coming online nicely. In addition, we recently began enrolling participants into the second Phase III trial, Reliance II, which is a mirror study of Reliance I. Top-line data from these two trials are expected in the first half of next year. The Reliance long-term open-label safety study is also underway, and the rolling participant has planned. Reliance OLS will include both participants from the PIVA studies as well as the novel participants. The data for this long-term open-label safety study will be part of the NDA filing package. We remain on track to initiate the study, evaluating the use of REL 1017 as a monotherapy for NDD during the current quarter. At a very high level, the most significant difference between this trial and the ongoing clinical studies is the patient population. The patient population plan for MDD monotherapy study will consist of people who are diagnosed with depression and they are not currently taking standard antidepressant therapy. We anticipate the completion of this study by year end 2021. Moving on, I would now like to provide an update on the human abuse potential or the HAP studies. And as we discussed previously, we discontinued the study 120. that was assessing REL1017 versus oral ketamine as an active control. As part of a pre-planned blinded analysis of the initial study completers, it showed that a significant material group of participants did not respond to the active control ketamine, and so most likely this lack of response was due to the poor bioavailability of oral ketamine. And this would have resulted in non-conclusive findings, so we decided to stop it. And we are now working toward initiating a new ketamine control study. We call it Study 126, which will use as an active comparator intravenous IV ketamine that has an established history as an effective positive control. We plan to complete this study by year-end of this year, so end of The second HAP study, the ABUSE study, study 124, is comparing REL 1017 to OxyContin. It's progressing as planned, and we continue to expect to complete the study by end of the current quarter. These HAP studies are a standard component of the NDA submission for many CNS drugs, and will inform the assessment of REL 1017 for the scheduling. The app studies also represent an important opportunity to add to the existing very strong body of literature that clearly differentiates REL1017 from the parent drug, racemic methadone, and any potential perceived association with opioid effect or dissociative symptoms. I'm also happy to share the RELMADA just completed presentation of a total of nine posters over three different scientific congresses. I will provide a brief overview of the data for REL 1017 that we presented. However, before I do that, I will turn the call over to Chuck for his review of the financial. Chuck?
spk08: Thank you, Sergio, and good afternoon, everyone. Today, we issued a press release announcing our business and financial results for the first quarter ended March 31st, 2021, which I will now review. For the first quarter ended March 31st, 2021, total research and development expense was approximately $14 million as compared to $4.5 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. Total general and administrative expense for the quarter ended March 31st, 2021 was approximately $8.4 million as compared to $5.5 million for the comparable period of 2020. The increase was primarily due to an increase in stock-based compensation. With the first quarter ended March 31st, 2021, we recorded a net loss of approximately $22.2 million or $1.34 for basic and diluted share compared to a net loss of $10.7 million or 72 cents per basic and diluted share in the comparable period of 2020. On March 31st, 2021, the company had cash, cash equivalents and short-term investments of approximately $102.7 million compared to $117.1 million on December 31st, 2020. We continue to expect that this strong cash position will support us through at least the multiple data readouts we anticipate through the first half of 2022. I will now hand the call back to Sergio for further remarks on the most recent progress. Sergio?
spk05: Thank you, Chuck. I appreciate it. As I mentioned, I'm happy to outline the recent data that we presented in nine posters across three different medical meetings. First, at the American Society for Pharmacology and Experimental Therapeutics. And we shared preclinical data that confirmed a lack of any neurotoxic feature that potentially linked to only lesion. This was totally not a surprise, but it's important because this effect has impacted safety and development of other MDR blockers like MK801. And these findings continue to support the consistent safety profile across preclinical and clinical studies. Next, at the Society of Biological Psychiatry, we shared a total of six posters that outlined new work to understand the underlying mechanism of REL 1017. What we found was very interesting and included additional support for a role in neural plasticity. And the insight regarding its binding to NMDR subunits, in particular the 2D subunit, which appears to explain both the lack of dissociative side effect as well as the rapid and sustained antidepressant effect. And lastly, we share the IDAPA, the American Psychiatric Association, the data from the Phase II study that showed that REL1017 demonstrated a statistically significantly rapid and sustained efficacy with large effect size. In addition to favorable safety and tolerability profile and absence of any sign of withdrawal after ending treatment. In summary, REL 1017 development program remains extremely active and we anticipate multiple key data results over the next 12 months. Importantly, as Chuck noted, we have a strong balance sheet. driving this robust R&D effort, and we have cash to support us through this expected data point. As always, I'm grateful to the RealMada team for their continued hard work and dedication to executing on our mission. And I would also like to extend my sincere thanks to the participants and clinical partners involved in the REL 1017 clinical trials for their effort in advancing this important therapy through the clinic as expeditiously as possible. I do believe that now we can open up for questions and operator, you can go ahead and open the line for questions. Thank you.
spk09: Thank you. At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. If at any time you wish to remove your question from the queue, please press star 2. 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. Our first question is from Andrew Tsai with Jefferies.
spk00: Thanks. Good afternoon and congrats on all the progress, our GON team. My first question is on the auction. oxycodone study, the data reading out soon. Very clear that, you know, all three doses need to be StatsAid versus placebo. I'm sorry, not placebo, but oxy, sorry, S-methadone, and then similar to placebo. But can you describe just how similar S-methadone should be to placebo on the VASC liking score? Because from time to time, I think of a scenario where What happens if smetadone is showing 60 to 65, for example, just outside of the typical placebo range? How would we interpret that result, I guess?
spk05: Thanks. Thank you, Andrew. Good afternoon, and thanks for the question. Well, look, it's a key question. Oxycodone 40 milligrams is what we use as a comparator. It's not a very high dose, but it's high enough that it's clearly likable by patients or people, participants that like to take narcotic as a recreational drug abuse. As a CNS drug, you may expect, we may expect that Yeah, it's not placebo, right? You're taking benzodiazepine or you take a sleeping pill. It's not placebo. You feel something. And if this feeling will be pleasant or not is very difficult to say, although all the data that we have seen so far, nobody really likes it. We have treated over 100 patients, and there is really no likability at all. If you really take in phase one, if you take a high dose like 150 milligrams, And some patients experience nausea, so that is not a very pleasant feeling. So to answer directly your question, the most important is to differentiate all three doses of esmetadone from 40 milligrams of oxycodone. We don't expect to be very different from placebo, but also it does not require that know we are similar to placebo so i would focus everybody's attention to the oxycodone placebo is there just because to have something to compare but it's not we are not comparing as methadone to to placebo right i hope i answered your question yeah thank you yeah very good and so um my follow-up question is um let's just say you know data is clearly positive completely clean
spk00: Would it then be fair for investors to assume that the second abuse liability study versus ketamine is pretty much de-risked because you would have seen data on, for example, dissociation, hallucination from the oxycodone study?
spk05: The straight answer is yes. I would say that I'm an old pharmacist, and I always say that drugs tend not to change the way they work. over time so we don't see anything that would show any dissociative or any hallucination or anything that would be like ketamine or like NMDA toxic effect there is no guarantee it's not 100% guaranteed but it's unlikely that in a different study will show up as a very different from what we see so far So yes, the answer is yes. You know, we do believe that there is a, the risk in component when we will see the oxycodone data.
spk09: Perfect. Thank you, Sergio.
spk05: Thank you, Andrew.
spk09: Our next question is from June Lee with Truist.
spk11: Hi, thanks for taking our questions. I believe the DEA is on record saying that dextrometharone is, it lacks addiction liability what's the basis for that, for DEA making that claim, and is that based on any specific study? And if so, what doses were used? And related to that, are you aware of DEA making similar claims about S-ketamine as compared to ketamine? Thank you.
spk05: Hey, June. Good afternoon. Thanks for the question. Yes, we actually, we asked the same question to the DEA, where they... the data that they based the statement that S methadone is exempt from abuse risk and respiratory depression. And they did not do any proper study that is not published. They based their statement and their opinion on what is available. And there is quite a bit of literature available, including the phase one that RealMata did with the single dose and multiple dose of esmetadone. So they look at whatever is available and they draw the conclusion. So that's pretty much how they did it. The comments on esketamine, well, esketamine, look, esketamine, it has been on the market for quite a bit of time in few European countries as an anesthetic to replace ketamine and is a lower dose. of racemic ketamine. Technically, pharmacologically, there is no difference between esketamine and racemic ketamine. So it's pretty much the same thing, just different dose. So I would be surprised if the DA would schedule esketamine in a different way than racemic ketamine. And the Johnson & Johnson, which provided, they performed the abuse study comparing nasal esketamines, provato versus intravenous ketamine, and pretty much they were the same thing. There was no real difference. Esketamine is pretty much, will remain the same schedule as racemic ketamine. With that said, maybe I can add one thing, that ketamine and esketamine, they are both Schedule III, that is very different from Schedule II, and there is probably more difference between Schedule II two and three than any other scheduling between three, four, and five. And the reason being that the major worry of the FDA is not really just the abuse potential, it's the safety. And while narcotic, opioid, oxycodone, Percocet, whatever is like a mu opioid agonist has that dangerous side effect that is respiratory depression that we have not seen with the S-methadone, Ketamine and escatamine, they don't do any respiratory depression. That's why they're used in kids and they're used as an anesthetic because they are very safe. So that's the reason that they are in Schedule 3, not because they are less abusable than Narcodio. You get less high with ketamine or escatamine, but because really they are not very dangerous in terms of overdosing. So I hope that helps.
spk11: Yeah. Just one more thing. There was a preplanned intern for the HAAP study using ketamine, which led to sort of a steady premature termination because of the lack of the effect there. A similar intern look was done for the study using oxycodone. And was there anything out of the ordinary that you saw on a blinded basis in that study? that OxyContin behave as it should based on historic data in terms of eliciting the likability?
spk05: Yes, that's a great question. The OxyContin study is going much faster than the ketamine because there is a lot more subject that like to abuse opioids than they like to abuse ketamine-like product. So we will have the blinded... whatever you call it, like quality control, but it's going to be very close to the end of the study. Fortunately or unfortunately, it will not help much. I believe it will be probably end of May or early June. The last patient is supposed to be out before the end of June. We won't be able to do much in terms of taking action like we did with CAT. With that said, especially oral ketamine, has a history of not being, like bioavailability is very variable and not being very likable in terms of abuse potential, while oxycodone, 40 milligrams is not a very high dose, but definitely it is much more likable than oral ketamine, 100 milligrams. So we do believe that it's going to be unlikely that we will see what we saw with that. with the ketamine study. We have seen in the qualification period where you select the participants, they are tested and they have to recognize and like the control, while ketamine, the percent of patients that were excluded from the qualification was over 50%. In the oxycodone study in qualification, the percent of people that are participants that they liked the control that was 40 milligram oxycodone was very high. It was close to 100%. We feel more comfortable about this study. Clearly, oxycodone is a much more easier control than ketamine.
spk11: Looking forward to the data, and thanks for taking our questions.
spk05: Likewise. Thank you, John.
spk09: Our next question is from Yatin Sinesia with Guggenheim Partners.
spk10: Hey, guys. Thank you for taking my question. Just a couple on the HAP side or human abuse liability study. I think, Sergio, you were just talking about the scheduling. Can you maybe help us understand how each of these studies help you from a scheduling perspective? If you show a static difference versus oxy and ketamine, do we know you're not going to get the same level of scheduling? And then the other part of the question is, what type of scheduling would you be okay with? Do you expect some form of scheduling with 1017? So that's the first question. I do have another follow-up.
spk05: Thanks, Yasi. So let me ask you the question a little bit more expanded way to be very clear. to be very clear. So the scheduling is determined by a process that involved the CSS, that is the control substance stuff that is a piece or part of the FDA. The CSS advises the FDA, then the FDA kind of give recommendation to the DA and the DA makes the final conclusion. All these happen after approval. The DEA has 90 days after approval to determine the scheduling. The scheduling is based on a and it's called a factor analysis that includes the pharmacology the mechanism of action the receptor affinity the danger how dangerous the drug and includes the likability how much you know potential abuser like the drug clearly the likability it is a key factor as well as safety right if you show safety like ketamine then the FDA clearly looks at things in a different way. So to answer directly your question, if the data that we will see and hopefully that we hope we will see, they are statistically different from oxycodone, all three doses of esmethadone, we cannot say this is an FDA and VA decision. We cannot give you the 100% certainty. But it's going to be extremely unlikely that it will be the same schedule of Schedule 2. I mean, it could be a higher schedule. Then it will depend on what the ketamine study will show. But definitely being Schedule 2, when you see a total statistically different score from oxycodone 40 milligrams, that would be extremely surprising data. That would happen. That's also with the old body of data that are already available that show like a very high safety profile and there is no respiratory depression. The most frequent or the most like the dose limit in toxicity is nausea. And so that makes us pretty comfortable that if we show these results, it's not going to be scheduled to. And to the second part of your question, what kind of, you know, what schedule we would be happy with? Well, dextromethorphan is behind the counters. There's not even a prescription. Now, we definitely do not expect as methadone, first because it's a new chemical entity, when it's very unlikely, it's impossible. It's not going to be an over-the-counter of anything like that. But, you know, the benzodiazepine and the... sleeping pills and, uh, you know, they are scheduled four or five. If you ask me directly, and this is not the guidance of what the scheduling of as methanol will be, but I would say it's kind of four or five is pretty much the same as, as a non-schedule. Uh, schedule three is very, right. It's very benign. And there is many drugs are scheduled three and, uh, you know, they are, they are prescribed very, very widely. So let me answer your question directly. I would be happy with Schedule 2 and above. I don't think commercially it would make any difference. Schedule 2 would be an issue. We cannot hide that.
spk10: Yeah, very helpful. And the other question I have is on the monotherapy study. Can you maybe help us understand a little bit more in detail any particular feedback you got from the FDA, the type of patient you're going to enroll? any standard medication that is allowed. It seems like you are guiding for completion of the study this year. Do you mean the data will become available this year or just maybe provide some color there?
spk05: Yes, these are two parts, right? The feedback from the FDA, I'm not sure I'm allowed to say anything, but let me try to phrase it in a nice way. The monotherapy protocol is very similar to the Reliance 1 and 2, to the add-on therapy. The only difference is the patient population. They are not taking any treatment, while the other one they are taking a treatment. So we are in process with the two phase three as add-on therapy. And so let's put it in this way. We don't expect that there is anything that is particularly worrisome about the monotherapy. It's the same thing. So the FDA was okay with the add-on therapy. We do believe that they are okay with the monotherapy as well. I hope I answered you in some way. Thank you. The data, well, yes, the patient population for monotherapy is much larger than about, I would say, at least two to three times the patient population for add-on therapy. So recruitment is being guided to like six, seven months recruitment. And we are planning to start before the end of March. of this quarter, that is over the next two, three, four weeks. So we should be on time to get it done by year-end. We're always a little cautious in terms of top line because it's always, it takes some time to, you know, clean the data and the statistical analysis. And year-end, it comes around Christmas. So I'm sure you don't want to have, you know, to write a note on RealMada on December 24th. that would not be so. Yeah, but it should be done around the event. Got it. Very helpful. Yeah, there is always JPMorgan. I don't know if it's going to be virtual or in-person, but there's always JPMorgan in general. It's usually a nice stage if you have some good data to share. But, you know, we haven't even started, so I don't want to give you any particular guidance. It's too far away to give you something specific. It's going to be around there. Thank you.
spk09: Our next question is from Salveen Richter with Goldman Sachs.
spk04: Hi, thanks so much for taking our questions. This is Sonia on for Salveen. So at APA, you presented some data on REL 1017 where the effect was a function of percent life years since onset of MDD. Just wondering if those findings will influence the design of your monotherapy trial at all?
spk05: Thank you, Sonia. Yeah, that's a very good question. The straight answer is no. The overall idea is to mimic as much as possible the overall standard population, so we don't want to pre-select. And we should have to stratify. We discussed it, but we should have had to stratify the patients based on how long they have been affected by depression. And, you know, it was an extra work, but, you know, the FDA likes to see, like, real-world studies. So, you know, we prefer to just do it in a, like, standard way without stratifying. So we will enroll patients that have depression for 20 years and patients that have depression for, like, two months. So the straight answer is no. There was no impact from these data. The way we read, you know, these data that have been imported for one year a specific reason. The NMDA antagonists like Hesmetadone, they have this feature, they are neuroplastic, so they increase the functionality and the number of synapses in the brain, the communication between brain cells. It is very different from SSRI. You may remember I was involved in the development of PROSA for quite a bit of years, for five or six years. And SSRIs, SNRIs, the old traditional antidepressants, they tend to be more, they are symptomatic, right? They treat the symptom of depression. And if you satisfy the patient from long-term depressed patient and short-term depressed patient, you don't see any difference with traditional antidepressant because they don't have really a neuroplastic effect. Unlike what we have seen as methadone, that the neuroplastic effect is more evident, especially this patient was treated for a week. So if you have been depressed for 25 years and you get treated for a week, it's unlikely you see a drastic effect that you actually have seen in patients that were depressed for a shorter time. So most likely in patients that have been depressed for a long time, it's going to take a little bit more longer treatment. And so that's, we probably, we may see something in phase three. The understanding and the learning from this data is that it's confirmed, there's a confirmation that NMED antagonist, OS methadone, they have a different mechanism and they do something different to patients with depression. So it's, I would say, in quotes and very carefully that we are looking more at disease-modifying effect instead of being asymptomatic. I hope that helps.
spk09: Thank you. Once again, if you have a question, please press star 1. Our next question is from Jay Olson with Oppenheimer.
spk06: Oh, hey, Sergio. Thank you for taking the questions and congrats on all the progress. Since SAGE has an important catalyst coming up with data from their MDD study, can you just talk about what some of the differentiating features are for an NMDA antagonist versus a GABA PAM and what you think would motivate MDD patients to prefer S-methadone versus their analone? Thank you.
spk05: Thank you, Jay. You always ask me tough questions. Well, you know, there is quite a bit of differences between the allosteric modulator and the GABA modulator like SAGE and Praxis than NMNDA channel blockers like Smetadon. So the mechanism is totally different, although ultimately at the end, we do believe that also the GABA modulator modulator. They may have some influence on the NMNDA process and activity, but it comes from a different angle and quite a bit the opposite angle. So probably mechanistically they're very different. In terms of activity, probably I know what is available publicly from SAGE and from Praxis, but they tend to have a, you know, they are rather fast acting, but they tend to like have a shorter term efficacy profile. So they are more suitable. And this is, you know, that's what Sage is claiming. And, you know, they definitely know a lot more than I do, but, you know, they're more suitable for an episodic short term treatment of depression. And we do believe there is a market for that too. So it's, you know, it's a very large market. So there is enough space for, drugs with different profiles. So they are quite a bit different. The bottom line is that there is very little correlation between the two, different mechanisms of action, different clinical profile. We hope they all work.
spk06: Likewise. And thank you for that. I guess since you had a number of posters that you presented at recent medical meetings, Can you just talk about any feedback that you got from physicians and KOLs at those conferences?
spk05: Yes. Unfortunately, virtual is not the same thing. To sit there and to hear the whole talking and the direct comments when they see the poster. So there is a little bit of guessing here. But the feedback was definitely positive. And the feedback it looks like, you know, based on data, esmetadone is starting to differentiate, not only from racemic methadone. Look, the fact that esmetadone is different from an opioid is very clear to me. You see all the data. You have seen them as well. But also in terms of, like, the other NMNDA antagonists, right? Because the question that we have been asked and we asked ourselves is why esmetadone, even at very high doses, Forget narcotic effect, that is not there. But even the hallucination, the dissociation, the ketamine-like effect is not there, even at doses that, you know, patients or healthy volunteers, they cannot tolerate. And that one was one of the angles that came up from this study, right? There is a mechanism, I don't want to go too much in detail of an earning call, but the specific activity for the substance unit 2D of the NMNDA receptor, unlike ketamine that it seems more, it works on the 2D, but it also is as affinity for the A and B. They are more related with the physiological activity of the NMNDA system and the glutamate. And that could explain or should explain, you know, the fact that S-methadone does not have this dissociative hallucination effect, even at high doses. So, you know, it seems that the differentiation process is moving ahead rather successfully. We are learning, too, right? It's not, you know, we saw the clinical, so we are looking of the reason that the clinical profile looks like that. And, you know, we make good progress in really understanding how this method works, and it's fascinating.
spk06: Excellent. That's super helpful. Thank you for taking the questions.
spk05: Likewise, Jay.
spk09: Our next question is from Mark Goodman with SVB Lyric.
spk07: Hi, this is Julian Call from Mark. Thanks for taking my question. So can we put more color on the enrollment of the reliance trials? They're still targeting 55 sites for each study. And how should we think about the COVID impact on the clinical conduct of these trials as the pandemic condition continues to improve? Thank you.
spk05: Thank you, Julian. And my regards to Mark. Well, let me start with the COVID impact. In terms of enrollment, we have not seen, especially now with the vaccine, we have not seen really any impact that would slow the enrollment. And if any, clearly you can read that everywhere. I mean, there's been an increase in patients affected by depression following the COVID situation. You know, people had COVID and have consequences with the depression related to the aftermath of the virus, but also, you know, the old economic situation and the old, you know, everything that we know enough about it. So, no, there has been no impact from the COVID situation on the world. It's a bit early to, like, give exact guidance of how we are going. You know, we started like three months ago in December, January to enroll the first one. And then recently a few weeks ago, we started to enroll the second one. So, you know, it's moving. The sites are, you know, most of the sites are already in place for the, but definitely for the Reliance One. Reliance Two is coming very fast. So we learn from the first one. So we've been a lot more efficient in activating sites and starting to enroll patients. So far, so good. We don't really expect any major impact, barring catastrophic events that are not predictable. But the COVID definitely is not an issue.
spk07: That's very helpful. I also have a quick question for Asgene. I think there was an increase in stock-based compensation in OneQ. So should we expect similar levels of spending for the remainder of the year, or is this more of a one-time payment?
spk05: I do believe that this is a question that Chuck can answer.
spk08: Yes, I am. Yeah, we've had a few fluctuations in stock-based compensation based on either folks leaving the company and their stock options being brought back in-house. But the stock-based compensation expense that you saw in Q1 of this year is a reasonable trend that you can expect, you know, throughout the next few quarters.
spk07: Got it. Yeah, that's very helpful. Thanks for taking that question. We have a follow-up question from Julie with Truist.
spk03: Mr. Lee?
spk11: Sorry, I was on mute. Sorry. And thanks for taking our follow-up question. Per FDA guidance, the HAP study should be conducted in, you know, experienced recreational users with recent history in the same general pharmaceutical class or pharmacological class. So, for the HAP study using OxyContin as an active comparator, those subjects are experienced in oxycontin or oxycodone or that class, not necessarily methadone. Is that a fair assumption?
spk05: Yes, it is a fair assumption. Look, methadone is used widely as a replacement for maintenance, but it's not a highly abusable opioid for a variety of reasons. Two in particular. One is that it's a long half-life, so you don't have the peak that you have with the oxycodone or immediate release. That's what the drug abuser or the recreation, they want the high, right? If you have a slow onset, it's not something they like in particular. The second one is that racemic methadone, part of racemic methadone is dextromethadone. Dextromethadone is an MNDA and it really does not have any, we do believe that does not have any narcotic effect. So it's not something that even recreational drug abusers, they like a lot.
spk11: Very helpful. Thank you.
spk09: Ladies and gentlemen, we have reached the end of the question and answer session, and I would like to turn the call back to Dr. Traversa for closing remarks.
spk05: Thank you, operator. So thank you all for joining on the call today, and we are very pleased to share the recent progress with you. as the REL 1017 Clinical Development Program continues to advance. We are excited about the important catalysts ahead of us, and we'll keep you updated on clinical readouts and activities throughout the remainder of 2021. Thank you again all for joining us on the call, and enjoy the rest of the day. Thank you.
spk09: This concludes today's conference. Thank you for your participation. You may disconnect your lines at this time.
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