Relmada Therapeutics, Inc. (NASDAQ:RLMD) Q2 2022 Earnings Conference Call August 11, 2022 4:30 PM ET
Company Participants
Brian Ritchie – LifeSci Advisors
Sergio Traversa – Chief Executive Officer
John Hixon – Head of Commercial
Maged Shenouda – Chief Financial Officer
Conference Call Participants
Andrew Tsai – Jefferies
Yatin Suneja – Guggenheim
Andrea Tan – Goldman Sachs
Joon Lee – Truist Securities
Jay Olson – Oppenheimer
Uy Ear – Mizuho Securities
Operator
Good day, ladies and gentlemen, and welcome to the Relmada 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 LifeSci Advisors. Please go ahead, sir.
Brian Ritchie
Thank you, operator, and thank you all for joining us this afternoon. With me on today’s call are Chief Executive Officer, Sergio Traversa; John Hixon, Head of Commercial; and Chief Financial Officer, Maged Shenouda. This afternoon, Relmada issued a news release providing a business update announcing financial results for the three and six months ended June 30, 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 provision of the Private Securities Litigation Reform Act. We caution listeners that during this call, while 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 31, 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. 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. Please go ahead, Sergio.
Sergio Traversa
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 time lines associated with the multiple expected clinical trial readouts from REL-1017, our lead product candidates that we are currently studying as a paradigm shift in novel treatment for patients with major depressive disorder or MDD.
Following my comments, Maged 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 registrational Phase III 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 by 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 I and RELIANCE II in the second half of 2022.
As a reminder, RELIANCE I and RELIANCE II, our two ongoing Phase III sister two-arm placebo-controlled pivotal studies, evaluating REL-1017, 25 milligrams as a potential adjunctive treatment for MDD. RELIANCE III is the ongoing Phase III two-arm placebo-controlled registrational study evaluating REL-1017 25 milligrams as a potential monotherapy single-agent treatment for MDD.
All participants in all of the RELIANCE trials take a loading dose on day 1 of 75 milligrams, three targets of 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 disorder.
Our commercial preparations have also continued with an expansion of our senior management team. Most recently, we are thrilled to welcome John Hixon to Relmada’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 your first conference call with Relmada, just joined and I’ll be happy if you can say a few words.
John Hixon
Hi, everyone. 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 Relmada team. So as Sergio said, I’ve got a pretty broad background in commercialization, all 31 years with Eli Lilly, we’re in commercialization-related roles. I was fortunate to spend eight years outside of the U.S. and 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 life cycle. And once that role ended, I was shifted over to be the brand launch leader for Cymbalta, Lilly’s next antidepressants and pain drug.
After launching this drug and being with it for several years post lunch. 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, it’s just very exciting for me and one that I’m very passionate about. I think the drug has exciting — 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.
Sergio Traversa
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 weeks treatment.
Let me provide an update on the ongoing RELIANCE I and RELIANCE II study. As a remainder, 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-milligram of REL-1017. Both studies have studied the use of REL-1017 in addition to a standard antidepressant for participants who have had inaccurate response to at least one and up to three standard antidepressant therapies.
The primary endpoint is the change in address the scale that is used to evaluate the severity of patient and MADRS score at day 28. Key secondary end points include the change in MADRS score at day 7 and change in clinical global impression severity scale that CGI has scored at day 28.
At 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 successful decent points on day 28. We report REL-1017 is a chronic treatment for depression. Both RELIANCE I and RELIANCE II 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 is enrolling both rollover participants from all three people of the studies as well as a de novo participants. RELIANCE-OLS is ongoing and continue to evolve participants as planned. Later from this long-term open-label safety study, we now expect in the first half of 2023, will be part of the pending rolling NDA filing package.
Finally, while Maged will review our financials 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, we are far less challenging than they are today, these financings has provided us with the maximum financial, operational flexibility as we ended the second quarter with cash, cash equivalents and short-term investments of approximately $222 million. With that, I will now turn the call over to Maged for a review of the financials. Maged, the stage is yours.
Maged Shenouda
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 30, 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.
For the second quarter ended June 30, 2022, the net loss was $39.9 million or $1.33 per basic and diluted share compared to a net loss of $26.6 million or $1.56 per basic and diluted share 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?
Question-and-Answer Session
Operator
Thank you. [Operator Instructions] We take our first question from Andrew Tsai with Jefferies. Your line is open. Please go ahead.
Andrew Tsai
Okay, thank you and good afternoon. Thanks for taking my questions. Thanks for the update. So first one is that it sounds like RELIANCE III of the monotherapy read out in maybe two months, give or take. I think you’ve said RELIANCE I, the first of two adjunct studies was tracking a few weeks behind RELIANCE III. Is that still the case? And if so, would you consider bucketing both data sets together? Or would you choose to press release the two data sets at different times?
Sergio Traversa
Good afternoon, Andrew and thanks for the question. Let me ask you for the second part. No, we are not planning to release RELIANCE III and RELIANCE I together for a couple of reasons. One, that probably they are not close enough that we could pack all the data together. And the second one that 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 or primary secondary endpoint as much as we can disclose. So — and the two trials, they have their own independent life, although they are similar. But single-agent monotherapy needs a different conversation compared to what is called the adjunctive treatment therapeutic choice.
So we will publish the top line data separately for these couple of reasons. In terms of timing, — moving forward, I mean, now we do have a pretty clear idea what the timing is. We expect the last patient to be enrolled in RELIANCE III, 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 get the top line results. So you can do the math, right? It’s going to be end of September maybe very early October with this range.
But we are getting there. And RELIANCE I, that one is a little bit more difficult to time so precisely, but you can assume that, I would say, six to eight weeks after maybe a little earlier than that, we should be done with that same process. Yes, we will announce the last patient out for both trials.
Andrew Tsai
Perfect. Thanks, yes 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 that 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, it’s draw you for association, any of these across the Phase IIIs and the open-label portion. They would have alerted you, just to be clear.
Sergio Traversa
Yes. So the straight answer is yes, they wouldn’t — we would know they would have alerted us if there would have been any issue related with withdrawal symptoms or anything — any safety signal would be signaled. They meet regularly on a time base or sometimes we don’t even know if they met — the last time I remember was June.
And so they — they meet regularly. And we haven’t heard anything except continued as planned as a recommendation. So it’s always, I mean, this business in biotechnology, developing drugs, you can never make really assumptions that with zero risk. But we are at the very end of the massive program. We have all Phase I, Phase II data.
We did 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 about that safety is not going to be let a really a road block, safety abuse. All these — we have so many information. They’re all very consistent to suggest that there is no safety for abuse issues.
Andrew Tsai
Fantastic, all right. Thanks for taking my questions. Best of luck.
Sergio Traversa
Thank you, Andrew. I’m sure we will speak soon with data.
Andrew Tsai
Of course.
Operator
Thank you. We take our next question from Yatin Suneja with Guggenheim. Your line is open.
Yatin Suneja
Hi guys, thank you for taking my questions. I have just one question, and this is on the tolerance 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 mechanism and MDA 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? Thanks.
Sergio Traversa
Yes, thank you, Yatin and thanks for the question. Yes, so like they are base historically. Let me start from like scientifically. And like from the science, there is no indication that NMDA channel blockers, they generate any tolerance or anything like that. Clinically, the issue is the ketamine I would not use it as a like a very good comparison as ketamine and I mean, they are given intermittently for practical reason, one is nasal and you can go to the clinic to take a drug every day and not to drive for 24 hours.
So the limitation that make the intermittent treatment regimen the one — the only one that is really feasible. So that’s in terms of like the developing tolerance may not be the best comparison. Dextromethorphan that one of our peers competitors is trying to get approved. It does — didn’t show any sign of any tolerance.
The efficacy continue to — continue to be there and improving up to six weeks, if I remember correctly, you know that much better than I do and the program well. So dextromethorphan didn’t show any — it doesn’t show any tolerance momentum or whatever it’s very difficult to evaluate the efficacy on a primary drug, but at least didn’t show really any particular loss of the effect.
Maybe the one that we are looking into is dextromethorphan combined with ketamine. I believe now is part of Otsuka and it’s a chronic treatment for pseudobulbar syndrome and also chronic treatment doesn’t show any loss of efficacy all the time. So all in all, we don’t expect that REL-1017 we saw 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. That’s not possible. So — but we do expect like a continued improvement up to day 28, definitely not a loss of efficacy.
Yatin Suneja
Yes. Got it. One more, if I may. I think in the past, you have talked about on a blinded basis, what the dropout rate 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.
Sergio Traversa
Yes, thank you, Yatin. You always ask me tough questions. Look, the — it’s always dangerous to draw any conclusion from buying the data and you know that better than anybody else, right. 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 II, right. Phase II goes to day 14, Phase III goes to day 28, so they’re not directly compared. But whatever we have seen, it looks very, very similar to Phase II.
And so that’s all we can share. Look, we look at blinded data that we get them two, three months later. And so it’s not — these are not very updated information. So they can still change. But now the message is that, they look 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 doing in the Phase III.
So that’s the big question mark. But in terms of like overall color, they are very overlap in the Phase II data, both monotherapy and adjunctive and they look very similar. I hope I give you a — but it is the best answer I can give you.
Yatin Suneja
Thank you, Sergio.
Sergio Traversa
Thank you.
Operator
We take our next question from Andrea Tan with Goldman Sachs. Your line is open.
Andrea Tan
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 conversations with the agency regarding the use of RELIANCE III to support an expanded label?
Sergio Traversa
Yes, good afternoon, Andrea, and thanks again for the question. That’s a very interesting question. This one came — I don’t want to say that came as a surprise and because we filed the application because we hope and we expect to — that to get the Fast Track 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 least at the very minimum belief that there is a need for something new as a single-agent treatment of depression.
And we are very pleased to see that. And maybe that they think for whatever thing that REL-1017 can bring something new and good for patients. What that means — it’s — 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 way pretty easily. And — 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 like 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. I hope I answered your question.
Andrea Tan
Got it. Maybe a follow-on there. Just has the agency, I guess, maybe in these conversations you’ve been having with them maybe suggest that, that RELIANCE III can be used as — I mean maybe it can be used as a pivotal study to support expansion into the monotherapy setting?
Sergio Traversa
Well, yes, we do. I mean the — we — I think it’s a bit fair assumption that RELIANCE III will be a pivotal trial that will support the approval of REL-1017 as a monotherapy, single-agent treatment of depression. And clearly, it’s — yes, we will present to the FDA a full package. And with RELIANCE I and RELIANCE II, 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 it’s important. It’s a very — the fact that we received this designation for Fast Track. Now we see it as a very positive signal to get that indication.
Andrea Tan
Perfect, and then maybe if I can ask one question to John. Just — 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?
John Hixon
Yes, thanks, Andrea. That’s a good question because there continue to be a lot of dynamics in the depression market space. And the way I see things, and a lot of my viewpoint is based upon interactions with psychiatrists and KOLs in regards to this. Everybody is 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 — maybe not 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 benefit.
So I think with the other agents that are in a similar phase as ours is in, it’s good to bring new options to the marketplace because it 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 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 II 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 who 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 that 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 the 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 III data comes close to what we’ve seen in Phase II, 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 here and I answered your questions sufficiently, Andrea?
Andrea Tan
Yes, great. Thank you so much, John.
John Hixon
Thank you.
Operator
Thank you. We take our next question from Joon Lee with Truist Securities. Your line is open.
Joon Lee
Hey, thanks for taking our questions. Are you also using a loading dose in Phase III as you did in Phase II? And are there other antidepressants that also use loading doses and were the loading dose is also used in our human abuse potential studies?
Sergio Traversa
Hey, Joon, good afternoon, and thank you as well for the question. Yes, we do use the loading dose and we use in Phase II, and all the three Phase III trial patients they take three tablets, 75-milligram the first day of treatment. And yes, the reason we’re doing that is it is to shorten the steady state that is a long last 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 feature of REL-1017 is the rapid acting. So the more you get to efficacy and blood levels, large models, the better. Your question — go ahead.
Joon Lee
No, no, no. Thanks for the clarification. So the FDA wasn’t worried at all that having that three times of dose on the first day might possibly have such an effect that, that might lead to an unblinding of the randomization?
Sergio Traversa
No, no. No, we have seen nothing in Phase II, and we have seen nothing in Phase III as well. It’s a very benign drug. And the loading dose in Phase II for the highest dose was actually 100 meg or four tablets or solution in Phase II. It was the correspondent for tablets.
And there was no sign of anything that could signal and like that you are taking the drug is not the placebo. To answer the other part of your question, there are other antidepressants that use loading dose. I don’t have anything on the top of my mind. I do know that there is a few of them, 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 you titrate to the effective dose. I don’t have anybody — anything on my mind of adding on to your question that includes loading dose. But tolerability, we see it as a big advantage. If you can give 3x 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 we don’t have enough safety and tolerability, they can do that. Otherwise, there’s no reason not to do it.
Joon Lee
Thank you so much.
Sergio Traversa
Thank you, Joon.
John Hixon
Thank you.
Operator
[Operator Instructions] We take our next question from Jay Olson with Oppenheimer. Your line is open.
Jay Olson
Hey, thanks for taking the question. Maybe for John, just curious about the due diligence he did and congrats to him on joining Relmada. 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 Relmada? And then what are the greatest challenges you expect to face in the launch of REL-1017? And how do you plan to overcome those obstacles? And then I have one follow-up, if I could?
John Hixon
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 this space a long time, I’ve been watching Relmada’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 just quoting them in their viewpoint, given what they’ve seen so far. And then when I probe a little bit further as to why that was, they say, 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 Lilly, guys, 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 #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 Relmada’s 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, it’s a derivative of marijuana or it’s a cannabinoid. It came out as a Schedule V and then after about a year or two on the market, it became descheduled. And I think that’s 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.
Jay Olson
Yes, that was super helpful. Thank you so much and congrats again for joining Relmada. If I could maybe squeeze in one follow-up question for the team. Since most registrational MDD 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 in REL-1017 and specifically — [indiscernible] 28, how long patients should be on therapy?
Sergio Traversa
Yes, it does we have to see the Phase III data first. And — but we discussed it internally. The — there is really no — in general for antidepressant 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 different from the other one.
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 already completed six months, and we have quite a bit of patients completed 12 months. And really, there is no sign for any long-term safety or tolerability issue. So in terms of safety and tolerability, we will be able to tell the doctor, we have that data at least until 12 months.
And we feel very comfortable that nothing surprising will show up. In terms of efficacy, when you have that kind of safety and tolerability, it depends on the patients. There are patients that take the treatment chronically, there are patients that when they are out from the depression that they want to stop and eventually we take 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 would do, the day 28 — from the conversation with the FDA, day 28, it means chronic treatment that will not stop at day 28. So when you had a label for chronic treatment, technically, you can use it as long as you would like to — as long as the patients require a treatment.
Jay Olson
Okay, thank you. That’s helpful.
Operator
We will take our next question from Uy Ear with Mizuho. Your line is open.
Uy Ear
Hey, guys. Thanks for taking my questions. 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.
Sergio Traversa
Thanks Uy and thanks for the question. Yes, we will schedule a pre-NDA meeting. We would like to have at least one Phase III 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-NDA meeting. We will provide the old package that will go from preclinical CMC to the clinical. Clearly, the Phase III, the clinical part would be the one that will be the topic of discussion from communication with the FDA that go back two 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, Maged is in the call. Maged is actually the lead on the manufacturing. We are well advanced. We have well enough product not only to complete the Phase III, but also to go beyond that. And I believe Maged correct me if I’m wrong, but we are making the commercial batches. So CMC will probably be filed with the FDA. We have a rolling NDA, so we’ll be filed — before we filed the clinical package. Maged, do you have anything to add?
Maged Shenouda
No, that’s a great summary, Sergio. Thank you for the question, Uy Ear.
Uy Ear
Can I sneak in another question, if I may, can I — just wondering the amount of cash that you end the quarter with — could you remind us on what that would take you through?
Maged Shenouda
Sure. Sure. So we ended the quarter with $212 million. And based on our internal estimates, that will take us out to mid-2024.
Uy Ear
Okay, thanks.
Maged Shenouda
Sure, thank you for the questions.
Operator
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.
Sergio Traversa
Sure. Well, thanks, everyone, for the time and interest in our program. And in closing, I am and remain very grateful to the Relmada 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 advance of 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 half year ago, what worry me the most was. 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’re almost there, and that’s thanks to the team and the patients and the clinicians will help out on this. So thanks a lot. And with that, I believe the call can be concluded, and I wish everybody a wonderful rest of the day and the wonderful evening. Thank you very much.
Operator
And ladies and gentlemen, that will conclude today’s conference. We thank you for your participation. You may now disconnect.
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