Home Bancorp Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
August 7, 2024

There are 8 speakers on the call.

Operator

Good afternoon. Welcome to the Larymoda Therapeutics, Inc. 2nd Quarter 20 24 Earnings Conference Call. This call is being recorded on Wednesday, August 7, 2020 4. I would now like to turn the conference over to Tim McCarty, LifeSci Advisors.

Operator

Please go ahead, sir.

Speaker 1

Thank you, operator, and thank

Speaker 2

you all for joining us this afternoon. With me on today's call are Doctor. Sergio Traverza, Chief Executive Officer and Maggie Gianuda, Chief Financial Officer. This afternoon, Ramada issued a press release providing a business update announcing financial results for the quarter ended June 30, 2024. Please note that certain information discussed on the call today is covered under the Safe Harbor's provision of the Private Securities Litigation Reform Act.

Speaker 2

We caution listeners that during this call, Ramada'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 Ramada's press release issued today and the company's SEC filings, including in the annual report on Form 10 ks for the year ended December 31, 2023, and with subsequent filings, including the Q2 2024 10 Q filed after the close today. This conference call also contains time sensitive information that is accurate only as of the date of this live broadcast on August 7, 2024. Ramada undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this conference call.

Speaker 2

Now I would like to turn the call over to Sergio. Sergio?

Speaker 3

Thank you, Tim, and thanks to everyone for taking time to join us this afternoon. BRAMADA is dedicated to the development of transformative medicine for people living with central nervous system disorder. And I'm pleased to report that Vamada's clinical program has made meaningful progress over the last 5 months. We believe that the portfolio led by the Phase III program for rel1017 as a potential adjunctive treatment for major depressive disorder or MDD is poised to reach several important milestones and we are encouraged by the company's progress. As a quick reminder, RASM-seventeen is a small molecule that preferentially blocks a hyperactive brain channel called NMNDA receptor that is associated with MDD.

Speaker 3

ResNet-seventeen has been designed Completing the Phase III program of OREL1017 is Renata's number one objective and it will complete the study package required to file the NDA. During today's call, we will discuss the planned interim analysis planned by year end 2024 for the RELIANCE II study review the timing to complete enrollment in the 2 Phase III studies in the rel=ten seventeen program, outline timing to initiate the Phase 1 study for bapropathy psilocybin program rel=p11 development for metabolic diseases and comment on our cash balance, which we expect to support our planned operation into 2025 and several key clinical milestones, especially for the rel=ten-seventeen program. I'll briefly review our program and in a few minutes, Maggie will provide you with a summary of our 2nd quarter financial. After that, I will make a few closing remarks and then we will open the call for your questions. Starting with the rel=ten seventeen.

Speaker 3

We are enrolling 2 pivotal Phase 3 studies for RAL1017, RELIANCE 2 and RELITE. These studies built on positive Phase 2 data with REL1017 for the adjunctive treatment of depression. Our clinical data set also demonstrated that RAS1017 is well tolerated with no indication of abuse potential. Our ongoing Phase III studies are designed to assess the impact of REL1017 of the MATRA score as an indicator of depression The studies are evaluating REL-ten seventeen in patients with documented clinical depression undergoing treatment with an approved antidepressant. Each of the ongoing studies, RELIANCE 2 and RELITE, is enrolling up to 340 subjects.

Speaker 3

The studies are randomized 1 to 1 and designed and powered to detect 2, 2.5 points delta in the MADRAS score at day 28. The protocols have been thoughtfully designed to incorporate several elements intended to de risk each study with a thorough patient adjudication process. As a snapshot, the features that we have emphasized in the RELIANCE 2 and RELiCE studies are Topazone, optimizing the protocol, careful selecting study sites and monitoring the number of patients per site, and most importantly, carefully verifying the diagnosis of depression and each patient's medical history to ensure enrollment of patients with clinical depression. We have been especially focused on defining the patient enrollment criteria with ExtraCare. The current protocols include a review of medical and pharmacy records.

Speaker 3

The studies also require that patients have been treated with an approved antidepressant for at least 6 weeks and have experienced an improvement of less than 50% since starting treatment. Adoption of these elements has increased our confidence that we are appropriately enrolling the most suitable patients into RELIA2 and RELYTE. As a result of these efforts, changing in the screen failure rate can be considered one way to access the stringency of the ENHANZE and volume criteria. As of today, we are observing an approximately 80% screen failure rate versus a 50% screen failure in the RELIANCE-one study. We intend to reach 2 important milestones by end of the year, reporting the output of a preplanned interim analysis and completion of enrollment of Reliance 2.

Speaker 3

We expect completion of enrollment in real life to follow approximately 6 months after that. The preplanned interim analysis of RELIANCE 2 study is intended to be a derisking tool to increase the probability of a successful study outcome. The analysis will include a futility analysis and the sample size re estimation, if necessary, with the potential to adjust the sample size to ensure proper statistical powering. There are 3 potential outcomes from the interim analysis. The study is futile, the study can continue with the addition of certain number patients and the study can continue with the preplanned number of patients that, of course, is what would be our preferred outcome.

Speaker 3

We will conduct the interim analysis and expect to report the outcome of this analysis before year end 2024. Now I would like to spend a few moments on RELP11. We identified the metabolic activity of RELP11 as sort of our preclinical evaluation on its potential effect on neurodegenerative disease. As a quick reminder, RAL B11 is a low dose modified release formulation of psilocybin. Compelling data from a recognized preclinical rodent model of metabolic dysfunction associated steatotic liver disease or MASLD published last year at November at the American Association For the Study of Liver Disease is the cornerstone of our programs.

Speaker 3

These data show that relp11 has a benefit on multiple metabolic parameters, including triglyceride levels and glucose metabolism. Beside reducing steatosis of the liver, relp11 reduced blood, glucose and body weight without producing any side effect on the CNS. This data led to our evaluation of P11 as a candidate for the treatment of metabolic disorders such as obesity. We plan to initiate the Phase I single adjunctive dosing or SAD study, Innovative Subject, for relp11 shortly. The Phase I study will define the pharmacokinetic safety and tolerability profile for relp11 and allow us to select a dose for evaluation in the Phase IIa approval concept study.

Speaker 3

We expect to complete the Phase I SAD SAD study and initiate the Phase IIa study in H1 first half of twenty twenty five. Now I would like to turn the call over to our Chief Financial Officer, Megha Schnuda to review our recent financial results. Megan?

Speaker 1

Thank you, Sergio. This afternoon, we issued a press release announcing our business and financial results for the 3 6 months ended June 30, 2024. During today's call, I will provide a brief overview of the 3 month financial results. Full details are available in our press release and 10 Q filing on our website located in the News and SEC filings tabs of the Investor Relations page. Research and development expense for the 3 months ended June 30, 2024, were approximately $10,700,000 compared to $13,700,000 for the same period in 2023, a decrease of $3,000,000 The decrease was primarily driven by a decrease in study costs associated with the completion of 2 Phase 3 trials and the long term open label safety RELIANCE 3 trial or Study 310.

Speaker 1

General and administrative expense for the 3 months ended June 30, 2024 were approximately $8,100,000 compared to $12,300,000 for the same period in 2023, a decrease of approximately $4,200,000 The decrease was primarily driven by a decrease in stock based compensation expense. The net loss for the 3 months ended June 30, 2024 was $17,800,000 or $0.59 per basic and diluted share, compared with a net loss of $25,300,000 or $0.84 per basic and diluted share for the same period in 2023. I will also note that the company had 30.17 1,000,000 common shares outstanding as of August 2, 2024. As of June 30, 2024, Raumada had cash, cash equivalents and short term investments of approximately $70,400,000 compared to $96,300,000 as of December 31, 2023. Cash used in operations for the Q2 was $13,300,000 Based on our current clinical development plans, we believe our current cash position is adequate to support operations into 2025 through key milestones, including the top line data from the RELIANCE II study.

Speaker 1

Before we go to your questions, I'll turn back to Sergio to make a few closing comments. Sergio?

Speaker 3

Thank you, Megan. As we conclude the prepared remarks on this afternoon's call, I would like to leave you with a few key messages. Our 2 Phase 3 studies for our lead product RAL1017 for MDD has been thoughtfully designed and are being carried out with appropriately adjudicated patients with potentially derisked studies. We expect 2 important milestones from the RELIANCE-two study before the end of the year with the output of a preplanned interim analysis, which include both a futility analysis and a simple size re estimation, if necessary, and the completion of enrollment of the RELIANCE 2 study. We expect completion of enrollment of RELIANCE to follow-up approximately 6 months after that.

Speaker 3

Preparation are on track to begin the clinical program for RALP-eleven, our proprietary silosided formulation for metabolic disorder later this quarter or early next quarter. We believe our financial resources will support our planned operation in 2025 through key milestones, including top line data from the RELIANCE study. At this point, operator, we can open the call for questions. Hello, operator, are you there?

Operator

Apologies. And ladies and gentlemen, we will now begin the question and answer session. Your first question comes from the line of Mark Goodman with Leerink Partners. Please go ahead.

Speaker 4

Thanks for taking my question. This is Rudy on the line for Mark. Can you remind us the baseline measures for an ongoing RELYSE-two study and how that compares with the Phase 2 ATTENDYMDD trial and the Phase 3 RELIANCE 1 study? Thanks.

Speaker 3

Thank you for the question. And so the baseline MADRAS average when the patient's population starts, they are very similar. It's right in the mid-30s, like 33, 34 range for all the studies. That's pretty typical for depression studies. Got it.

Speaker 3

So that answers your question.

Speaker 4

Yes. Just a quick follow-up. What gives you the confidence that RELINE will finish enrollment 6 months after RELINE 2? And would a potential simple size re estimation impact the timeline for that trial?

Speaker 3

Yes. Well, the confidence that we when Reliance 2 will be over and if successful, as we hope, then all the resources will be put on realigned. So we have like close to 100 sites that will be available. Of course, we may not enroll all of them. So like the full resource is dedicated to the studies.

Speaker 3

And so we do our confidence that based on the enrollment rates that we are seeing now, we can finish in about 6 months. And sorry, the second question was how we're confident about the time lines for the sample size re estimation?

Speaker 4

No, I was asking whether the sample size re estimation will impact the time line for the second trial?

Speaker 3

That's a good question. Well, we will address it when we know how many patients we have to enroll, but it could, but it's probably not going to be very material. When we are talking about sample size or estimation, we are not talking about adding like 200 patients to the study. That would be like would be probably a problem in general. And so like sample status re estimation will evaluate how many if and how many patients would have to enroll.

Speaker 3

Got it. So the answer to your question is that it may, but it's not going to be a material timeline change. Very helpful.

Operator

And your next question comes from the line of Andrew Tsai with Jefferies. Please go ahead. Andrew, you might be on mute. Andrew Chai.

Speaker 5

Hi, can you hear me?

Speaker 3

Yes, now yes.

Speaker 5

Yes. Hi, thanks for taking my question. So on clinical trials, we noticed there are some changes to the estimate patient enrollment estimated patient enrollment number to 340. I think you mentioned it in the prepared remarks. So can you talk about why that number changed from 300 to 340?

Speaker 3

Yes, sure. Good afternoon, Andrew. Well, clinicaltrials dot gov is more a general like indication that is made mostly for the FDA. And it's an indication, right? The patient population would be up to 340.

Speaker 3

It doesn't mean that we'll go to 340. You don't want to change like the update clinicaltrials.gov too frequently. And so you put some guidelines that you expect to be meeting. And also you have to like depends if you include dropouts and non dropouts. But the number of patient is up to 340.

Speaker 3

That doesn't mean that we have to go to 340, assuming no sample re estimation. So I don't I will not take that as the final number. The final number would be determined by the statistical plan that we have not finalized. We usually send to the FDA the statistical plan as close to the end as possible because there is no upside defining numbers before, depends on the enrollment rates and the values parameter. So I hope I answered your question.

Speaker 3

I don't take the 3.40 as like the final absolute number. It's up to 3.40.

Speaker 5

Got it. Yes, very helpful. And it sounds like there's a futility analysis in the interim now. So did you have to change the protocol or the stats plan? And are you taking any statistical penalty with the futility option?

Speaker 3

Thanks, Andrew, for asking the question because it's very important. And we did spend the last, I would say, couple of months to work on the statistical plan. And I'll tell you why because when we had in the Study 301, we had an interim review. And what we get from the data monitoring committee was they stopped the trial as early as possible. But we had absolutely no indication of what was the reason for that.

Speaker 3

Could have been futility or could have been efficacy. And that one was actually didn't really help Ramada because we stopped it as indicated. At the earliest, there was like 220 was 2027 patients. And the results were not the one we were expecting. If we would have gone to the 300 plus that was planned, maybe the study based on the numbers could have been statistically significant, especially because the second part of the trial was conducted when the COVID restriction were lifted.

Speaker 3

And you may remember that the results of the last 63 patients enrolled in 301 were actually very, very good compared to the previous 165 patients. So that internal analysis was not only not very helpful, it actually creates a little bit of a problem. So this time, we don't want to end up in the same situation. So we have been very carefully planning the interim analysis that we want within the boundary of what can be done, of course, we want to get some information that can help to derisk the problem. And so we inserted a futility analysis.

Speaker 3

So at least we want to know, we hope not, but we want to know if the study is futile, then we may decide if it is not the case to continue to preserve the cash that we already have. It is significant, the cash that we have already in our hands. And then there is a second scenario that is temporary estimation that DMC will give us an indication how many patients we should add to get to a likely p value. Then there is the 3rd scenario that is the one that the most the one that everybody likes the most. They will tell us that we can stop the trial at the planned number of patients that would be around the 300, 310 or whatever is the final number would be defined in the statistical analysis and statistical plan.

Speaker 3

And we will know if that would be what the DFC will tell us. We will know that the study is not futile because if it is futile, we will be informed and that we don't have to add any patients to get to a potential P value. There's no guarantee then the study was successful because that we may have some more patient to add that they are not incorporated in the statistical analysis at the interim, but clearly would give some good sense that we are on the right direction. And the last of your question was the statistical penalty. No, there is no alpha penalty in the futility analysis because there is no analysis on the efficacy and there is no early stock.

Speaker 3

So you don't pay any alpha penalty. I hope that was a long answer, but I wanted to be very clear and specific on this. Yes.

Speaker 5

Thank you. And very last one is what would be the threshold for futility if the placebo adjusted delta is below a certain point on MADRS? Or do you have any color on that?

Speaker 3

Yes. That's more difficult to answer, not because we don't want to, but we haven't finished or finalized the analysis. And then we get into the like heavy complicated statistics. But in general, we would say we will set the futility close to what can be a non clinically meaningful threshold, right? If the study would not have a chance to reach it like any clinically meaningful results, then probably would not be worth to continue.

Speaker 3

But we haven't finalized what the numbers will be.

Speaker 5

Thank you again.

Speaker 3

Thank you, Andrew.

Operator

And your next question comes from the line of Andrea Tan with Goldman Sachs. Please go ahead.

Speaker 6

Good afternoon. Thanks for taking the question. Sergio, just really quickly, could you remind us the extent of the trial that you expect to be completed ahead of the interim analysis? And following that, how soon after that could we expect to see the top line data?

Speaker 3

Let me be sure I understand. Hi, Andrea. Good afternoon. Let me be sure I understand your question. Do we do have another trial before the interim analysis?

Speaker 3

No, the only two trial they are ongoing for rel=ten seventeen is VARIANCE2 and RILIGHT. Everything else has been completed. Long term safety, they're all done.

Speaker 6

I'm so sorry. I'm so sorry. I was just asking in terms of the interim analysis that's being conducted or planned for RELIANCE 2, I guess maybe what proportion of that study is it? I think you may have mentioned in the past that it's around 80% to 90% of the trial at which point the interim analysis will take place?

Speaker 3

I got it. Sorry, I misunderstood. Theoretically, the latest you do it, the better. Now there is the incremental benefit that you get it going like, let's say, a 70% or 75%, 80% become smaller and smaller. So we'll try to do it as late as possible, but we also want to know.

Speaker 3

And so it is going to be like before year end, right, over the next, let's talk or so, the next, I would say, 3, 4 months. It takes a couple of months to prepare it. And so we are pretty close. We are pretty close.

Speaker 6

Okay. And if the DMC advises that you could continue without additional patients being enrolled, maybe what is the expected time frame over which we could then expect the top line data?

Speaker 3

Well, it depends on many patients we have to enroll, but it's not going to be that far away. And I don't have the exact number, but we are planning to finish enroll by year end. So you can imagine that it can be by year end or sometime early 2025, but not too long after. If they tell us that we don't need to enroll any more patients as we hope, it's going to be pretty short after that.

Speaker 6

Okay. And then one quick question on the psilocybin study. Just curious or if you could speak to the decision to run that study in Canada and if that reflects any regulatory hurdles in the U. S. Or maybe even a variation how the different agencies view psilocybin?

Speaker 3

Yes. Well, we do it in Canada for two main reasons, right? One is that Canada for some reason, they have very good structure for Phase 1. Just to give you an example, resplendentine, resplendentine, resplendentine, phase 1 was done in Toronto in Canada because they have very good facilities. And the second one is that the Canadian agency, it is very used to psychedelic and or it's used to more than the FDA.

Speaker 3

So it's the regulatory hard drugs are easier in Canada than in the U. S. So the combination of these two, reason made us do it in Canada. Nothing else,

Operator

right. And your next question comes from the line of Oi Ihir with Mizuho Financial Group. Please go ahead.

Speaker 7

Hi, thanks for taking my question. This is Charles on for Oi. I guess I had a question on the re estimation analysis. Just I guess kind of dig into how many more patients you might add potentially in this analysis? Is that kind of a preset number or will they give you that number?

Speaker 7

And then also on the runway guidance, is the runway still expected to read out to for Relight as well? Thank you.

Speaker 3

Thank you, Charles. I will Meghat answer the second question. But the first one is the number will be recommended by the DMC. And so it can be anywhere, right? Clearly, if the target number is somewhere north of 300 and we don't expect to double that number of patients, so to add like 200 patients, there would be an indication that the signal may not be that strong.

Speaker 3

So it would be a reasonable amount of patient that is also feasible in a reasonable amount of time.

Speaker 1

And Charles, thank you for the question. I'll take the financial the finances question. I don't think we want to get that specific with regard to the readout from the RELITE study. What we have said is it will take us into 2025, certainly with data from the RELIANCE 2 study. And then a lot depends on enrollment patterns and that's developing day by day.

Speaker 1

So, I can't be that specific at this point.

Speaker 7

Okay. Thank you for taking my question.

Speaker 3

Well, I assume there are no more questions pending. And so we are not showing any more questions. So I can go to the closing remarks.

Operator

Yes, presenters. We don't have any questions at this moment. You can now proceed with the closing remarks.

Speaker 3

Okay. Well, thanks a lot. And so thanks, everyone, for joining us for the Remada Second Quarter 2024 conference call today. We believe we are poised to achieve several important milestones that could represent an inflection point for Ramada. We look forward to updating you on our progress and thank you for joining us for this Q2 business update call.

Speaker 3

Have a great night.

Operator

Thank you, presenters. And ladies and gentlemen, this concludes today's conference call. Thank you all for participating. You may now

Speaker 3

disconnect.

Powered by Quartr
Earnings Conference Call
Home Bancorp Q2 2024
00:00 / 00:00