Relmada Therapeutics, Inc.

Ladies and gentlemen, and welcome to the RealMata Therapeutics Inc. Second Quarter 2022 Earnings Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Brian Ritchie of LifeSite Advisor. Please go ahead, sir.

Thank you, Operator, and thank you all for joining us this afternoon. With me on today's call are Chief Executive Officer Sergio Traversa, Don Hickson, Head of Commercial, and Chief Financial Officer, Maggot Shenouda. This afternoon, ROMADA issued a news release providing a business update announcing financial results for the three and six months ended June 30th, 2022, and filed its quarterly report on Form 10-Q with the SEC. 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, LaMotta'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 LaMotta'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 31st, 2021, and subsequent filings. This conference call also contains time-sensitive information that is accurate only as of the date of this live broadcast, August 11, 2022. Ramada 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. Please go ahead, Sergio.

Thank you, Brian, as always. And good afternoon to everyone. I'm pleased to welcome you to the Relmada Second Quarter 2022 Conference Call. During today's call, I will review our recently achieved milestones and provide an update on the anticipated timeline associated with the multiple expected clinical trial readouts from REL 1017. Our lead product candidate that we are currently studying is a paradigm-shifting novel treatment for patients with major depressive disorder, or MDD. Following my comments, Magat Shenouda, our chief financial officer, will review our financial results and balance sheet, and we will then take your questions. We are approaching multiple key catalysts from our ongoing late-stage Reliance clinical development program. Specifically, we anticipate completing the enrollment of Reliance III the ongoing monotherapy registration on phase three trial shortly. More specifically, we expect to enroll the last patient in this trial before the end of August, probably earlier than that. This will be followed soon thereafter by a top-line readout of the study in the second half of this year. We also continue to expect top-line results from reliance one and reliance two in the second half of 2022. As a reminder, RELAS-1 and RELAS-2 are two ongoing Phase III sister two-arm placebo-controlled pivotal studies evaluating REL-1017-25mg as a potential adjunctive treatment for MDD. RELAS-3 is the ongoing Phase III two-arm placebo-controlled registrational study evaluating REL-1017-25mg as a potential monotherapy single-agent treatment for MDD. All participants in all of the Reliance trials take a loading dose on day one of 75 milligrams, three tablets, or REL-1017. We are also delighted to share that the FDA very recently granted fast-track designation to REL-1017 as a monotherapy single agent for the treatment of major depressive disorders. Our commercial preparations as have also continued with an expansion of our senior management team. Most recently, we are thrilled to welcome John Hickson to RealMada's head of commercial. John has over 36 years of sales and marketing experience within the biopharmaceutical industry, including a 31-year career with Eli Lilly and company. John is on the call, so before I go further, John, would you like to say a few words? Is it your first Conference call. We'd remind you to just join, and I'd be happy if you can say a few words.

Well, hi, everyone. Thank you, Sergio. It's a real pleasure to be with all of you, and I just want to say that I'm thrilled and humbled and excited to be a part of this Real Mata team. So as Sergio said, I've got a pretty broad background in commercialization. All 31 years with Eli Lilly were in commercialization-related roles. I was fortunate to spend eight years outside of the U.S. in Spain, South Korea, and Australia. While in Australia, my team and I launched Zyprexa, the atypical antipsychotic. And then when I returned to the United States, I became the last global marketing director for Prozac as it was late in its product lifecycle. And once that role ended, I shifted over to be the brand launch leader for Cymbalta, Lilly's next antidepressant and pain drug. After launching the drug and being with it for several years post-launch, I shifted over to new product planning where I worked with discovery and development scientists and provided assessments of commercial viability of Lilly's portfolio and also was actively engaged in various business development opportunities. And so, again, I'm just thrilled to have this opportunity. I know the depression space well. Depression is something that, like perhaps many of you, has impacted members of my family and close friends. And having this opportunity to bring forward a new approach to treat depression, if the drug is approved, is just very exciting for me and one that I'm very passionate about. I think the drug is truly an exciting new treatment option. So, again, thank you very much. Let me turn this back over to Sergio so we can continue on with you all. Thank you.

Thank you, John, and we are really very happy to have you on board with us. Moving on to the current status of the Phase III program, as I said earlier, we continue to anticipate the completion of enrollment in Reliance III, the ongoing monotherapy single-agent registration of Phase III trial, with the last patient enrolled before the end of August, followed by the top-line data readout shortly after the completion of the four-week treatment. Let me provide an update on the ongoing Reliance 1 and Reliance 2 studies. As a reminder, Reliance 1 and Reliance 2 are designed to evaluate REL1017 as an adjunctive treatment for MDD, and both include two arms, placebo and 25 mg of REL1017. Both studies are studying the use of REL1017 in addition to a standard antidepressant for participants, who have had inadequate response to at least one and up to three standard antidepressant therapy. The primary endpoint is the change in MADRAS, the scale that is used to evaluate the severity of depression, and MADRAS score at day 28. Key secondary endpoints include the change in MADRAS score at day 7, and change in clinical global impression severity scale, the CGI score, at day 28. Day 28 was chosen as a primary endpoint in agreement with the FDA with an understanding common that depression is a chronic disease and that success of decent points on day 28 will support 12, 10, 17 as a chronic treatment for depression. Both Reliance 1 and Reliance 2 are progressing as planned, and we continue to expect the availability of top-line data in the second half of this year. The Reliance Development Program also includes Reliance OLS, the Long-Term Open Label Safety Study. It is enrolling both rollover participants from all three people to study, as well as the de novo participants. Reliance OLS is ongoing and continues to involve participants as planned. Data from this long-term open-label safety study we now expect in the first half of 2023 will be part of the planned rolling NDA filing package. Finally, while Maggie will review our financial in detail shortly, I would like to emphasize how strong our financial position we are currently in. You can recall that we completed an oversubscribed follow-on offering for gross proceeds of $172 million in late December 2021, when the capital markets for biotech companies were far less challenging than they are today. This financing has provided us with the maximum financial and operational flexibility as we ended the second quarter with cash, cash equivalent, and short-term investment of approximately $222 million. With that, I will now turn the call over to Magid for a review of the financials. Magid, the stage is yours.

Thank you, Sergio. Today we issued a press release announcing our business and financial results for the three and six months ended June 30, 2022, which I will now review. For the second quarter ended June 30, 2022, total research and development expense was approximately $30.9 million as compared to $17.3 million for the comparable period of 2021. The increase was primarily related to an increase in costs associated with the execution of a broader clinical program for REL 1017. Non-cash R&D expense for the second quarter of 2022 amounted to $1.2 million. Total general and administrative expense for the second quarter ended June 30th, 2022 was approximately $14.6 million as compared to $9.1 million for the comparable period of 2021, an increase of approximately $5.5 million. The increase was primarily driven by an increase in stock-based compensation. This non-cash G&A charge totaled $11.1 million in the most recently completed second quarter. But the second quarter ended June 30th, 2022, The net loss was $39.9 million, or $1.33 per basic and diluted chair, compared to a net loss of $26.6 million, or $1.56 per basic and diluted chair, in the comparable period of 2021. Turning to the results for the six months ended June 30, 2022. Total research and development expense was approximately $55.9 million, as compared to $31.4 million for the comparable period of 2021. Again, the increase was primarily related to an increase in costs associated with the execution of a broader clinical program for REL 1017. Non-cash R&D expense for the first half of 2022 amounted to $2.5 million. For the six months ended June 30, 2022, total general and administrative expense was approximately $27.9 million as compared to $17.5 million for the comparable period of 2021. The increase was primarily driven by an increase in stock-based compensation. This non-cash G&A charge totaled $21.7 million in the most recently completed six-month period. For the six months ended June 30, 2022, the net loss was approximately $79.7 million or $2.73 per basic and diluted share, compared to a net loss of $48.8 million, or $2.90 per basic and diluted share in the comparable period of 2021. As of June 30, 2022, as Sergio said, we had cash and cash equivalents and short-term investments of approximately $212 million, compared to cash, cash equivalents, and short-term investments of approximately $211.9 million at December 31, 2021. I will now ask the operator to please open the call for questions. Operator?

Thank you. Ladies and gentlemen, if you would like to ask a question, please signal by pressing star 1 on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, press star 1 to ask a question. We pause just for a moment to assemble the queue. We take our first question from Andrew Tsai with Jeffrey. Your line is open. Please go ahead.

Thank you, and good afternoon. Thanks for taking my questions. Thanks for the update. So first one is that it sounds like Reliance 3, the monotherapy, reads out in maybe two months, give or take. I think you've said Reliance One, the first of two adjunct studies, was tracking a few weeks behind Reliance Three. Is that still the case? And, you know, if so, would you consider bucketing both datasets together, or would you choose to press release the two datasets at different times?

Good afternoon, Andrew, and thanks for the question. Let me ask you for the second part. No, we are not planning to release Reliance 3 and Reliance 1 together for a couple of reasons. One, that probably they're not close enough that we could pack all the data together. And the second one, which is the most important, is that we want to be sure that everybody will have enough time to digest. It's going to be quite a bit of data, top line, primary, secondary, and point as much as we can disclose. And the two trials, they have their own independent life, although they're similar, but single-agent monotherapy needs a different conversation compared to what is called the adjunctive treatment therapeutic choice. We will publish the top-line data separately for these couple of reasons. In terms of timing, moving forward, now we do have a pretty a clear idea what the timing is. We expect the last patient to be enrolled in Reliance 3, we said before end of August, probably is going to be not too far away from today. So you calculate last patient in, four weeks, 20 days treatment. So you go somewhere in September, and then two to four weeks after that, we will have the top client results. So you can do the math, but it's going to be, you know, end of September, maybe very early October, this range. But we are getting there. And Reliance One, that one is a little bit more difficult to time so precisely, but you can assume that, you know, I would say six to eight weeks after, maybe a little earlier than that, we should be done with that. Same process, same process.

Great. Thanks.

Yeah, we will announce the last patient out for both trials.

Perfect. Thanks. Yep. And that's very clear. And second question is, can you remind us the last time the DSMB looked at the blinded safety data? I think the last time was March. Did they happen to look again? And if so, any updates on that front, I guess? And just to be clear, If the DSMB did see, like, I don't know, withdrawal, euphoria, dissociation, any of these across the Phase 3s and the open label portion, they would have alerted you, just to be clear?

Yes. The straight answer is yes. We would know they would have alerted us if there would have been any issue related with withdrawal symptoms or, you know, anything, any safety signal would be signaled. They meet regularly on a time base, so sometimes we don't even know if they met. The last time I remember was June, and so they meet regularly. We haven't heard anything except continue as planned as a recommendation. So it's always, I mean, this business in biotechnology, developing drugs, you can never make really assumptions. with zero risk. But we are at the very end of the massive program. We have all phase one, phase two data. We need this very large abuse potential with like 100 patients treated with many different doses. We have not seen one single issue related with safety. So I would say that we feel very, very comfortable that safety is not going to be like a real issue or a roadblock, safety, abuse, all these. We have so many information. They all very consistently suggest that there is no safety for abuse issues. Fantastic.

All right. Thanks for taking my questions. Best of luck. Fingers crossed.

Thank you, Andrew. I'm sure we'll speak soon with data.

Of course. We'll take a look. Thank you. We take our next question from Yatin, Tunisia. Your line is open.

Hey, guys. Thank you for taking my question. I have just one question, and this is on the tolerant side. So I think what we have seen from you is seven-day data. Can you just put in contact, Sergio, with this type of a mechanism, NMDA targeting mechanism, Should we expect any sort of tolerance development? Just trying to get a sense that how much more benefit we should expect out to 28 days relative to seven days that you have produced. Anything that you can point out to whether it's ketamine or other NMDA channel blocker that have produced things.

Yeah, thank you. Thanks for the question. um yes so like there are data historically let me start from like scientifically and uh like from the science there is no indication that nmda and channel gophers they generate any tolerance or anything like that clinically uh there is few example ketamine i would not you know i would not use it as a like a very good comparison, esketamine and esketamine, they are given intermittently for practical reasons. One is nasal, and you can go to the clinic to take a drug every day and not to drive for 24 hours. So there are limitations that make the intermittent treatment regimen the only one that is really feasible. So that, in terms of developing tolerance, may not be the best comparison. The dextromethorphan that one of our peers competitors is trying to get approved, it didn't show any sign of any tolerance. The efficacy continued to be there and improving up to six weeks, if I remember correctly. You know that much better than I do. And you know the problem well. So dextromethorphan didn't show any, doesn't show any tolerance. mementin for whatever, it's very difficult to evaluate the efficacy for an Alzheimer's drug, but at least it didn't show really any particular loss of the effect. Maybe one of the ones that we have looked into is dextromethorphan combined with canadine, I believe now it's part of Otsuka, and it's a chronic treatment for pseudobulbar syndrome. And also Chronic treatment doesn't show any loss of efficacy over time. So all in all, we don't expect that RAN1017 will show anything different. Clearly, if we take the Phase II data as a proxy, and we do, we should see a very sharp and fast effect at day 4, 5, 7, that range. And it cannot continue to increase efficacy beyond like much beyond that otherwise the mother will go below zero and that's not possible so but we do expect like a continual improvement up to day 28 definitely not a loss of efficacy yeah got it one more if I may I think in the past you have talked about on a blinded basis what the dropout rate yeah is for the study

Could you give us an update now that you are very close to the completion, what it is or how it is trending? Are there any differences that you're seeing between adjunctive versus monotherapy? And then also if you can comment on the percentage that might be rolling over to the OLE. Thank you so much.

Yeah, thank you. You always ask me tough questions. Look, it's always dangerous to draw any conclusion from blinded data, and you know that better than anybody else. So we look at the blinded data mostly, almost exclusively for safety reasons, and we have seen nothing, as I mentioned a few minutes ago. In terms of efficacy, until you know what The placebo effect is any number does not really tell you the truth. So what we can tell you is that on a blinded basis, with all the caution talking about blinded, they look somewhat similar or very similar to the phase two. Phase two goes to day 14. Phase three goes to day 28. So they're not directly compared. But whatever we have seen, it looks very, very similar to phase two. And so that's all we can share. Look, we look at the blinded data, we get them two, three months later. And so it's not, yeah, these are not very updated information. So they can still change. But, you know, the message is that they look very, very similar to the Phase II. Now, of course, we know what the Phase II placebo did because it's been published and we have the unblinded data. We don't know what placebo is. he's doing in the phase three. So that's the big question mark. But in terms of like overall color, they are very overlapping the phase two data, both monotherapy and adjunctive. And they look very similar. I hope I gave you.

Yeah, thank you. This is the best answer I can give you. Thank you, Sergio. Thank you.

We take our next question from Andrea Tan with Goldman Sachs. Your line is open.

Good afternoon. Thanks for taking my questions. My first one here is just, can you speak a little bit more on what fast track designation gives you here as it relates to the monotherapy indication? And just remind us maybe the nature or extent of your conversation to the agency regarding the use of Reliance 3 to support an expanded label.

Good afternoon, Andrea, and thanks again for the question. It's actually a very interesting question. This one came, I don't want to say that came as a surprise, because we filed the application because we hope and we expect to get the fast drug designation. What is very interesting is that there are 28 drugs approved in the United States, for depression. And the fact that REL 1017 has been awarded Fast Track designation for indication, but you have a lot of choices that probably they are not idea. It tells us that the FDA at the very minimum believes that there is a need for something new as a single agent treatment of depression. And we are very pleased to see that. Maybe that they think, or whatever, think that RAS1017 can bring something new and good for patients. What does that mean? There have been only nine, I believe, if I counted correctly, fast track designation awarded this year. So it's not something the FDA gives away very easily. But in terms of advantages, you have more access to the FDA. they tend to give you an answer quicker, and you have some more informal exchange of information and communication with the FDA. So it makes the process, I don't want to call it easier, but definitely faster, and there is more communication with the FDA. That is always good. So I hope I answered your question.

Got it. Maybe a follow-on there. Has the agency, I guess, maybe in these conversations you've been having with them, maybe suggested that Reliance 3 can be used as a pivotal study to support expansion into the monotherapy setting?

Well, yes, we do. We think it's a very fair assumption that Reliance 3 will be a pivotal trial. that would support the approval of REL 1017 as a monotherapy single-agent treatment of depression. And clearly, it's that we will present to the FDA a full package. And with Reliance 1 and Reliance 2, they will have a lot of information well enough to make a decision on what would be the best use for REL 1017. And single agent is important. The fact that we receive this designation for fast drugs, we see it as a very positive signal to get that indication.

Perfect. And then maybe if I can ask one question to John. I would be curious to hear your thoughts on the evolving depression landscape, just in the context of the new drugs that are potentially going to be approved over the course of this year. Curious how you think REL 1017 compares to these drugs and your expectations for where it might be able to be used in the treatment paradigm.

Yeah, thanks, Andrea. That's a good question because there continue to be a lot of dynamics in the depression market space. And, you know, the way I see things and a lot of my viewpoint is based upon interactions with psychiatrists and KOLs in regards to this. everybody's looking for new approaches to treat depression because everyone in the field understands that only so much remission is really truly achievable for so many patients. And patients tend to, it's not really that the best term, but they do tend to grind through a lot of different treatments to try to get to the one that offers the benefits. So, you know, I think with the other agents that are in a similar phase as ours is in, You know, it's good to bring new options to the marketplace because that just creates new and better, hopefully better opportunities for clinicians and patients to get to well, truly, realizing that that still is a difficult goal. And when I look into the future with, you know, further developments out there, such as the psychedelics, that brings another interesting dynamic that I think will be challenging from a payer reimbursement standpoint, without a doubt. But when I look back at where REL 1017 is, I just, given particularly the phase two data that I've had a chance to dig in on, that data suggests that this drug has the opportunity to truly provide fast antidepressant relief to patients, and they've been looking for that since the probably the second year of the SSRIs being on the market when everyone realized that it really did take a month or more to get any type of a benefit. So I think that REL 1017 is going to be able to fulfill that, again, based upon what I've seen in the Phase II data. And with a strong effect size, it could be game-changing out there versus other antidepressants. That's a strong signal. And on top of it, it appears to be safe. And the fact that it can be administered orally just is kind of that grail that people have been looking for to be able to really get patients to well. So I think the prospects for our drug are very positive based upon that. As long as the phase three data comes close to what we've seen in phase two, I think we've got a wonderful opportunity to really get patients into a much better situation. I hope I didn't ramble too long there and I answered your question sufficiently. Andrea?

Yeah, great. Thank you so much, Sean.

Thank you.

Thank you. We take our next question from Joan Lee with Tourist Securities. Your line is open.

Hey, thanks for taking our questions. Are you also using a loading dose in Phase 3 as you did in Phase 2? and are there other antidepressants that also use loading doses, and were the loading doses also used in human abuse potential studies?

Hey, John, good afternoon, and thank you as well for the question. Yes, we do use the loading dose, and we use it in Phase II, and all the three Phase III patients, they take three tablets, 75 milligrams the first day of treatment. And the reason we're doing that is it is to shorten the steady state that is a long half-life. So if you don't use the loading dose, it takes four to five days. With the loading dose, it is shortened to two to three days. That is very important because one of the features of Rel1017 is the rapid acting. So the more you get to efficacy and blood levels, plasma levels, the better. Your question? Go ahead.

Oh, no, no, no. Thanks for the clarification. So the FDA wasn't worried at all that having that three times a dose on the first day might possibly have such an effect that that might lead to an unblinding of the randomization?

No, no. We have seen nothing in phase two, and we have seen nothing in phase three as well. It's a very benign drug. And the loading dose in phase two for the highest dose was actually 100 milligrams for four tablets or solution in phase two. It was the correspondent for tablets. And there was no sign of anything that could signal that you are taking the drug, if not the placebo. To answer the other part of your question, there are other antidepressants that... use loading those. I don't have anything on the top of my mind. I do know that there is few of them of which one John knows very, very well. They require titration because if you take the full dose the first day, you get some side effects. So you need to start with a lower dose so that you titrate to the effective dose. I don't have anything on my mind of adding on to the question of loading those. But yeah, tolerability, we see it as a big advantage. If you can give three times the therapeutic dose to fasten the steady state and to fasten the onset of the effect, I don't think other drugs don't do it. They don't do it just because they don't have enough safety tolerability that can do that. There's no reason not to do it.

Great. Thank you so much. Thank you, John. Very clear. Thank you.

Once again, ladies and gentlemen, please press star 1 to ask a question, star 1 to ask a question. We take our next question from Jay Olson with Oppenheimer. Your line is open.

Oh, hey. Thanks for taking the question. Maybe for John, I'm just curious about the due diligence he did, and congrats to him on joining Realmada. If you could please comment on the feedback that you got from KOLs that you spoke to, and what are some of the lessons learned from your work at Eli Lilly and elsewhere that you hope to leverage at Realmada? And then What are the greatest challenges you expect to face in the launch of RHEL 1017, and how do you plan to overcome those obstacles? And then I had one follow-up, if I could.

Jay, thank you very much for the questions. So the due diligence that I did was extensive. And really, the way I did it was, since I've been in the space a long time, I'd been watching RHELMATA's data from afar anyway. But then when this opportunity arose for me, besides being very excited, I spoke to a lot of my psychiatry friends and I just said, hey, what are your thoughts about this drug based upon what you know at this point in time? And I have to say that every single one of them said that this drug looks extremely exciting to them. So I'm quoting them and their viewpoint given what they've seen so far. And then when I probe a little bit further as to why that was, they said, well, it does appear to work rapidly, it does appear to be safe. And while it carries the S-methadone name, they said that strong data and safety data will certainly win out over any type of reluctance or concern that some clinicians may have because the field is still looking for something that really is going to be efficacious and safe and easy from a patient administration standpoint. So that was very consistent in terms of the due diligence, which made the decision easy for me. And I've been doing other projects in the depression space, so it just cemented the decision that I was thrilled and an easy yes for me to join the team. In terms of lessons that I learned from Lily, gosh, there are a lot. I would draw first on my experience with Prozac, where the company obviously brought forward a revolutionary, iconic antidepressant, But as more and more competitors came in, I have to say, I think the organization, particularly my marketing organization, we started to move away from some of the basics of staying with our own positioning with Prozac and started to kind of follow what the competitors were doing. And what we learned late in the life cycle was to go back to our knitting and remain with the positioning concept that got Prozac to where it was. We employed that very same principle with Cymbalta as we prepared to launch it, realizing we were going to be antidepressant number 11, 12, or 13 into the U.S. marketplace. And so we needed to have a unique, ownable, and differentiating positioning concept around depression hurting, hurting both emotionally and physically. So that's something I really want to employ with RealMata is to come up with a positioning concept that will differentiate it from all of the other potential new entrants coming in around the same time period. And then the challenges to face, going back to the S-methadone, that's something that we know will be something we're going to have to work through and scheduling. But when I look at other analogs such as Epidiolex, the epilepsy drug that's a derivative of marijuana or it's a cannabinoid, it came out as a as a Schedule 5, and then after about a year or two on the market, it became descheduled. And I think that may be a very good analog for us to dig into and understand and to follow. I hope I answered your questions, Jay. Thank you.

Yeah, that was super helpful. Thank you so much, and congrats again for joining Romana. If I could maybe squeeze in one follow-up question for the team. Since most registrational MDV studies have more than 28 days of randomized treatment. Can you just comment, maybe Sergio, on what sort of guidance you would give to physicians for treatment durations beyond 28 days, 12, and 17, and specifically, how do you randomize patients beyond 28 days?

How long do patients need to be on therapy? Yeah, we have to see the phase three data first, but Right, we discussed it internally. There is really no specific, in general, for antidepressants, and John can help me out on that. Beyond the study period, you don't have a lot of guidance you can give. Also because every patient is a patient that is different from the other ones. In terms of safety, that's the guidance that we can clearly give. We have the long-term safety study ongoing. We have quite a bit of patients that already completed six months, and we have quite a bit of patients that have completed 12 months. And VA David is now not trying on any long-term safety or tolerability issues. So in terms of safety and tolerability, we won't be able to tell the doctor that we have that data at least until 12 months. and we feel very comfortable. Nothing surprising will show up. In terms of efficacy, when you have that kind of safe intolerability, it depends on the patient. There are patients that take the treatment chronically. There are patients that, when they are out from the depression episode, they want to stop, and eventually retake it if they get depressed again. So it's very difficult to answer this question. in a very simple way. It will be up to the doctor what they will do. The day 28, from the conversation with the FDA, day 28, it means chronic treatment. So that will not stop at day 28. So when you add the label for chronic treatment, technically you can use it as long as you would like to, as long as the patient requires the treatment.

Okay. Thank you. That's helpful. We take our next question from Uyir Mizuho.

Your line is open.

Hey, guys. Thanks for taking my question. Just wondering if you guys have already sort of or plan to schedule a pre-NDA meeting with the FDA. And just curious to know if... there's anything that needs to be aligned in terms of the NDA package, either on the preclinical level or the CMC level? Thanks.

Thank you, and thanks for the question. Yes, we will schedule a pre-NDA meeting. We would like to have at least one phase three data top-line results before we approach the FDA. I believe they will take us a lot more seriously if we have good Phase III data, but we will schedule a pre-MDA meeting. We will provide the old package that will go from preclinical CMC to the clinical. Clearly, the Phase III, the clinical part, will be the one that will be the topic of discussion. from communication with the FDA that go back to months ago, we do believe that the preclinical package is done. So there is no more request for any non-human studies or in vitro studies. And so in CMC, well, MAGIT is on the call. MAGIT is actually the lead on the manufacturing. We are well advanced. We have well enough product not only to complete the phase three, but also to go beyond that. And I believe, Maggie, correct me if I'm wrong, but we are making the commercial batches, batches. So CMC will probably be filed with the FDA. We have a role in the NDA, so it will be filed before we file the clinical package. Maggie, do you have anything to add?

No, that's a great summary, Sergio. Thank you. Thank you for the question.

Can I sneak in another question, if I may? Just wondering the amount of cash that you ended the quarter with. Could you remind us what that would take you through?

Sure, sure. So we ended the quarter with $212 million. And based on our internal estimates, that'll take us out to mid-2024.

Okay, thanks. Sure. Thank you for the question.

Thank you. It appears there are no further questions at this time. I'd like to turn the call back to Sergio for any additional closing remarks.

Sure. Well, thanks, everyone, for the time and interest in our program. And in closing, I am and remain very grateful for another team for their continued hard work and dedication to executing our mission. And I would like also to extend my sincere thanks to the participants and clinical partners involved in the REL 1017 clinical trials for the effort and in advancing this important product candidate through the clinic as expeditiously as possible. And it was a very, it is a very large program and The question I had, you asked me the same question like one and a half years ago. What worried me the most was that, you know, can we actually do a program of this size and this complexity? Well, now I can give you the answer. We actually did it. We are almost there. And that's thanks to the team and the patients and the clinicians that helped out on this. So thanks a lot. And with that, I believe the call ends. can be concluded. And I wish everybody a wonderful rest of the day and a wonderful evening. Thank you very much.

And ladies and gentlemen, that will conclude today's conference. We thank you for your participation. You may now disconnect.