Q3 2023 Relmada Therapeutics Inc Earnings Call
Good afternoon, ladies and gentlemen, and welcome to derail matter Therapeutics, Inc. Third quarter 2023 earnings conference call. At this time all lines are in listen only mode. Following the presentation. We will conduct a question and answer session. If at any time. During this call you require immediate assistance. Please press star zero for the operator this call is.
Recorded on Wednesday November eight 2023.
I'd now like to turn the conference over to Tim Mccarthy of lifestyle Advisors. Please go ahead.
Thank you operator, and thank you all for joining us this afternoon.
With me on today's call are Chief Executive Officer, Sergio Traverse, our Chief Financial Officer magnitude Judah.
Dr. Cedric O'gorman, Chief Medical Officer.
This afternoon <unk> issued a press release, providing a business update announcing financial results for the three and nine months ended September 32023.
Please note that certain information discussed on the call today is covered under the safe Harbor provision of the private Securities Litigation Reform Act.
Caution listeners that during this call remote as 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 real modest 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, 2022 and subsequent filings.
This conference call also contains time sensitive information that is accurate only as of the date of this live broadcast November eight 2023.
<unk> 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 would like to call turn the call over to Sergio.
Thank you team as always and good afternoon to everyone and welcome to <unk> third quarter 2023 conference call.
Yeah.
We have achieved some important clinical milestone recently in the ongoing phase III program for <unk> 17 in the major depressive disorder, <unk> as well as in our promising preclinical knows quite novel Psilocybin program did.
I will briefly cover today.
Following this.
Maggie will review.
Third quarter financial results and then we will take your questions.
Let's begin with an update on the phase III program for <unk> 17 with continues to proceed as planned.
As a reminder, <unk> is focused on developing <unk> as an adjunctive treatments MDT.
As previously communicated we have made critical changes to rely as to the ongoing study three zero to a phase III two arm placebo controlled pivotal study evaluating <unk>.
<unk> 17, 25 milligrams for adjunctive MDT.
The amended stood at 302 protocol is being implemented across all of our clinical sites.
Enrollment is progressing as we leverage our close relations with study sites and the number of ongoing initiatives to drive trial awareness with prospective patients.
As a reminder, we are planning to enroll approximately 300 patients.
And continue to expect that reliance too will be completed in the first half of 2024, most likely toward the end of the first half so around media.
In the second phase III trial of around 10, 17 named re light side.
304, we begin dosing patients during the third quarter.
<unk>.
Also has a planned enrollment of approximately 300 patients completion of enrollment in this trial continues to be anticipated in the second half of 2024.
To reiterate what we have said previously.
Like reliance <unk> is a randomized double blind placebo controlled four week trial evaluating the efficacy and safety of <unk> as an adjunctive treatment for IMTT in patient experiencing inadequate response to ongoing background antidepressants.
The primary end point of both studies is the same.
Change in the Madras total score from baseline to day 28 for relative 17, <unk> compared to placebo.
Also.
During the third quarter, we announced efficacy and safety results.
From the open label one year safety study for residents in study 310 or treated.
These long term safety exposure data are required for the purpose of the NDA filing.
More specifically in September we said efficacy result for the debt.
204 de novo or new to treatment patients and safety result for all 627 study subject.
Saudi rail 10, 17 310 treat then was a long term open label Noncompetitive open label Registrational Phase III trial designed to evaluate the efficacy and.
Safety <unk> 17 administered once daily in patients with MPD for up to one year.
I will now reiterate some of the previously communicated results in the de Novo patients.
Rapid and sustained improvement in Madras score where service in width, whereas been 17 in the de Novo patient and the entire study population.
It is the de novo patient reflect the more reliable picture the rehab work condition I will like the de Novo patient results.
The main macro score total score was 38 33 eight.
Eight at baseline.
Treatment with <unk> 17 in this space and resulted in meaningful demand from baseline in the <unk> total score.
$16 eight points at <unk> at <unk>.
One <unk>.
19, nine points at month, three and six and 22 five points at month 12.
High rates of clinical response, both rapid and sustained were seen in de novo patients.
When treated with <unk> 17 in the <unk> total score at day seven.
$26 six patients of the de Novo patient achieved a clinical response.
Is defined as the greater than or equal to 50% improvement.
In the <unk> score, which increased to 51% nine months, one and 77, 2% by month 12.
<unk> absence of depressive symptoms or clinical remission was achieved by <unk>.
<unk>, 1% of the de Novo patients at day seven.
Which increased to 31% at month one.
And then again, 54.4% at month 12.
Clinical remission is defined as the micro solar score of less than or equal to 10.
In summary, basically.
Patients treated daily with rather than 17 for up to one year experience that rabbit.
Clinically meaningful and sustained improvement in depressive symptoms and associated functional impairment.
Importantly, the overall macros change and response.
And remission results of this study railcar 17 310 for the de Novo patient aimed the full analysis set were consistent in both groups.
For all of the residence 17, three then subjects relevant CBD in 17.
Well tolerated with long term dosing showing low rates of adverse events and discontinuation due to adverse events no new safety signals were detected.
Moving now.
So how.
We're promising preclinical novel modified release Psilocybin program.
At next week or this weekend.
S L D meeting.
The new data will be presented in a poster presentation.
Data demonstrate the beneficial effect of non psychedelic load those silos typing seles typing on multiple metabolic parameters in a rodent model metabolic dysfunction associated.
They are thought it leber disease or a Saturday.
As a reminder, there are no currently approved drugs for <unk> Cindy.
And these initial preclinical results support the therapeutic potential and none of none psychedelic load those silos.
Based on these data, let's take it at a low dose psilocybin could improve lipid in glucose.
Levels with potential for fewer side effects or other investigating treatment approaches such as the <unk> ones.
We intend to initiate the single ascending dose phase one trial in obese patients with static liver disease in early 2024 to define the pharmacokinetics safety and Tolerability profile.
Our modified release silo sided formulation in this population.
Followed by a phase Iia trial in the same patient population to establish clinical proof of concept.
Moving on Maggie will provide a detailed review of our financials.
But I would like to emphasize that rely that remains sufficiently funded to fully execute our plans to reach data readouts for both relevant 17 phase II trials realized through and realized.
I will now turn the call over to Maggie to review, our second quarter financial results.
<unk>.
Sure. Thank you Sergio today, we issued a press release announcing our business and financial results for the three and nine months ended September 32023, which I will now review.
For the third quarter ended September 32023, total research and development expense was approximately $10 $5 million as.
As compared to $35 million for the comparable period of 2022.
The decrease of approximately $20 million. The decrease was primarily associated with the completion of reliance one study 301 and reliance three study 303 in late 2022, the noncash charge related to stock based compensation totaled $1 $7 million in the most.
The recently completed third quarter.
Total general and administrative expense for the third quarter ended September 32023 was approximately $12 2 million as compared to $8 $2 million for the comparable period of 2022, an increase of approximately $4 million. The increase was primarily driven by an increase in stock.
<unk> compensation this noncash charge totaled $9 $6 million in the <unk>.
Most recently completed third quarter.
Net cash used in operating activities for the three months ended September 32023 totaled $11 $6 million compared to $26 $9 million for the three months ended September 32022.
For the third quarter ended September 32023, net loss was $22 million were 73 cents per basic and diluted share compared with a net loss of $39 4 million or $1 31 per basic and diluted share in the comparable period of 2022.
Turning to the results for the nine months ended September 32023, total research and development expense was approximately $41 million as compared to $86 $5 million for the comparable period of 2022 a decrease.
Approximately $46 $4 million.
Again, the decrease was primarily associated with the completion of reliance one study 301 and reliance Green starting 303 in late 2022.
The noncash charge related to stock based compensation totaled $5 $5 million in the most recently completed nine month period.
For the nine months ended September 32023, total general and administrative expense was approximately $36 $8 million as compared to $36 $1 million.
Comparable period of 2022, an increase of approximately $700000 Inc.
The increase was primarily driven by an increase in stock based compensation. This net noncash charge totaled $28 $5 million in the most recently completed nine month period.
Net cash used in operating activities for the nine months ended September 32023 totaled $41 $4 million compared to $67 9 million for the nine months ended September 32022 for.
For the nine months ended September 32023, net loss was approximately $73 $6 million or $2 40, 45 cents per basic and diluted share compared to a net loss of $119 $1 million or $4.04 per basic and diluted share.
In the comparable period of 2022.
As of September 32023, we had cash cash equivalents and short term investments of approximately $106.3 million compared to approximately $148 $3 million as of December 31, 2022, again cash used in operations.
For the third quarter was $11 $6 million.
Just on our clinical development plan, our current cash position and provide us provides us with ample runway through the end of 2024 of note. This time period as Sergio mentioned includes data Readouts from both phase III trials for lines to that study 302 and relate that study 304 as well.
As the initiation of our planned phase one trial for <unk>.
Modified release cycle stylus type of formulation.
Now I'll turn the call over now to the operator.
Thank you ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press star followed by one on your Touchtone phone you will hear a three ton prompt acknowledging our request and your questions will be pulled in the order. They are received should you wish to decline from the polling process. Please press star followed by two.
If you're using a speaker phone please lift the handset before pressing any keys.
One moment. Please for your first question.
Your first question comes from Marc Goodman, <unk> Leerink partners Mark. Please go ahead.
Hi, Good afternoon. This is my answer Mark.
Congratulation on the quarter I know I have a question regarding to the life study.
This study conducted at the same sites as the alliance one.
Your line three.
And I also have a question about the.
BMD and the last one and three.
Three.
The patient characteristics can you remind us again about the average age of the participants.
<unk> looked at the data unblinded the data.
And have you noticed any correlation between that and accurate diagnosis of MTBE and each.
And the ease of the participants.
Thank you.
Great well. Thanks for the question I do believe that Cedric <unk>, our chief Medical officer as the most appropriate to address them Cedric.
Yes, Thanks, Sergio and thanks for the question so yes.
As is very common when you have controlled trials. You also have an open label extension trial that said that's offered so therefore, yes. The sites that were part of reliance one and reliance three also had the opportunity to be part of the open label study and contribute subjects too to that long term study.
Remember if there was a question then about the average age and.
These are these studies are.
Ron in adults 18 to 65 years of age and of course, you know that major depressive disorders is over is represented at a two to one ratio in females than males.
We haven't looked at H.
H breakdown, there's lots of interesting analysis that we will do but I can't comment on the correlation.
Our outcomes by age but.
The average age is probably in the area of the forties or fifties.
Got it thank you so much.
Okay.
Thank you. Your next question comes from you at year Mizuho Huie. Please go ahead.
Hi, This is Charles on for <unk>.
I guess I kind of a follow up question to that if there was any other read throughs from the open label de Novo patients to the Phase III Studies and then also if you saw a difference between the adjunct is mono therapy patients from that open label. Thanks.
Thanks, Charlie surgery yet.
Let me try to give you a little bit more like top down and then Cedric NGO more in detail and learning.
Look the long term safety studies 12 months and the we look at the my dress improvement data and the conclusion.
Simple, but.
A significant and material because these represent.
Real word.
Experience. So what we have seen is that there is a rapid effect.
And there is a.
Clear effect and the 70 plus percent of the patient responded after 10 months 12 months and N D B.
<unk> sustained so there is not also the efficacy overtime and to safety S confirm that the drug is extremely safely and well tolerated.
These are really the key learning in a in a real world experience that due to the the answer of the question too there is a difference in the adjunctive and and.
No therapy in the 12 months studies, not really very significant to make a difference it was not the case mix. So its way now.
It would be unfair to separate monotherapy from adjunctive, because we don't know right in 12 months, where people do that somebody take mitigation. They stopped then somebody doesn't pay themselves it would not be reliable.
Reliable.
Information, though I mean, we look at the de Novo and the overall people eight population that come from them from the the two phase III studies. It's over five 600 patients. There is really no difference that would be required. There is no. Let's put it. This way there is no subset of patients that would spike either way that the drug didn't.
Worked well they work extremely well is pretty consistent and that make us comfortable because this is a real world experience as Cedric do you want to add anything to my remarks.
I think you said it all just to <unk>.
Just to confirm what you said that there's this consistent.
Prudent trajectory with rapid onset the dinovo are the it's the ideal group to look at when you're when you're looking at efficacy in the open label because that study isn't as well controls as our placebo controlled trials you know on an on who gets in so there's a lot of that subjects and you don't in a lot of cum common.
And medications that they're on so it's quite a mixed bag, but one thing is consistent.
Really observed is that.
Whatever the treatment setting patients got better quickly with really high response and remission rates in the open label and consistent trajectory as we've also seen in the day.
The control trials.
Thanks, so much thanks for taking my question.
Thank you. Your next question comes from Andrew Tsai Jefferies. Andrew. Please go ahead.
Hi, Thanks, so much this is Peter on for Andrew.
Just had a couple of quick questions.
What are you what are each of your two phase III studies sort of power to show in terms of major separation versus placebo.
And.
A question for Cedric out operationally speaking how.
Can you say with high confidence the study integrity for the seats for the two phase III studies in 10 17 are similar to how axon successful studies were run are you seeing a lot of similarities between those two programs and if you could just elaborate on that thank you.
Yeah. Thanks, Edina, maybe you said it shouldn't answer that the maybe I just would like to try to answer your last question right on the compares are with axiom.
And Saturday runs both the trials running our try and run axon try, but here's a way baby different drugs. So I dunno, how much would be reliable to to compare the two programs and then Cedric do you want to try to answer that.
Sure.
No I think that.
That anybody who's in the drug development space, particularly in major depressive disorder.
Very much tries to run as high quality.
Our program is possible and that really comes down to.
Three things the protocol the site selection and subject selection and so.
It doesn't matter, which which sponsor you worked for you want to have a very tight.
Tight efficient protocol that.
That aims to reduce.
Placebo response, and then you want to work with the with the with the best sites that are conducting.
Conducting M D D trials and of course those of US who work in our in clinical research for Depression know that there are always the same sites you know no two known.
None to the sponsor.
You would you would expect that there would be no.
<unk> agent familiarity because these sites are the best in major depressive disorder.
And then you just have to very carefully a habit and eligibility process that make sure that you're avoiding.
That you are getting the right patients with confirmed diagnosis of M D D and you're avoiding professional patients.
And Youre doing everything from this subject selection process as well that might minimize a.
Recruiting or enrolling patients or subjects, I should say who might be prone to having a high placebo response. So you do that across the program then and I have to say that I'm very pleased with how rigorous our eligibility processes in letting subjects into the trial and.
Question on the statistical powering we haven't actually reveal that yet so you know what I mean, yes, it would be reasonable to.
If you if you take the phase II data and if you were to consider 301 or 303 were placebo controlled two by 10 or 11 points improvement on the mattress.
Could probably figure out.
How we're powering it because we are targeting approximately 300 subjects as Sergio mentioned at the beginning so I hope that helps a little bit.
It was an answer to your questions.
But if I can add just one quick point.
According to the Kols and the history later to a difference in my address score versus placebo to truly have points is considered a clinically meaningful and enough for approval. So you may imagine that we will write at the side the statistical plan.
In according to these parameters. So you know the statistic will will be set up to detect it.
My address different from placebo that is clinically meaningful and good enough for approval.
Hope I answered appropriate to your question.
Thank you, ladies and gentlemen, as a reminder, should you have a question. Please press star one on your Touchtone phone you're.
Your next question comes from Eaton <unk> Guggenheim. Please.
Please go ahead.
Hi, This is Dan.
Thanks for taking my question.
A few questions on that.
Hilton.
I just wanted to ask you if you have already.
Yeah.
And I really don't see study planning.
And then.
Do you expect it to three.
Thank you.
Yeah, sorry, I answered the first it said you hit the first part of the question. Then if you don't mind to repeat the second one because I couldn't hear you.
Very well so no we haven't filed the A&D.
On the process to to prepare the a and D and.
I do believe will be filed relatively soon but we are planning to start the phase one single dose Sheng Ding in Q1.
Next year, so and you know, let's say two three months from now and can you. Please repeat the second part.
Yes sure.
If you have that.
When you're doing.
Youre planning.
Danielle.
I expected it to.
Thank you Debbie Thanksgiving.
How many doses and no we havent finalized and.
The exact dose regimen will discuss India N D. A N D, but what they can I can share with you is what will be the dose limiting toxicity and it is not real toxicity, because we know that psilocybin is well tolerated from the literature and the history and from other pro.
They are ongoing they're using 2025 milligrams in a single dose and we will use 110th of that so it's.
It's a fair assumption that the dose will be used and will not be.
Talk C E O.
Or or in or not well tolerated in general term, but the those limiting to see see toxicity.
Trying to determine is when.
You start to have a cycle a cycle thematic psychological holes I say tactical psychosynthesis, putting in this way when you start to feel that the drug is affecting Julien.
Your site. So we are developing a low dose extended release.
That is non psychedelic.
So the dose limiting toxicity would be the psychedelic effect, but we don't know exactly what the dozy, but we assume that right now it would be like below three four milligrams daily.
Okay. Thank you.
Thank you there are no further questions at this time. Please proceed.
Well thank you.
In summary, we remain confident that our.
We do have an approvable drug in rather than 17, and we are excited about the potential or the novel silo side being in derivative programs.
We look forward to reporting the progress with our pipeline in the months ahead and I do remain grateful to the roadmap of the team for their continued hard work and dedication to executing on our mission I.
I would like to extend my sincere thanks to the patients and clinical partners involved in the Royal 10, 17 trials for their participation in the advanced advancement of these promising investigational medicine towards development. Thanks, a lot to everyone and we will.
Reconnect soon.
Thank you ladies and gentlemen. This concludes your conference call for today, we thank you for participating in that that you. Please disconnect your lines.