Q2 2023 Relmada Therapeutics Inc Earnings Call
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Greetings and welcome to Royal Mothercare purchase he can second quarter 2023 and conference call. At this time all participants are in a listen only mode. A brief question and there's actually following the formal presentation.
If anyone should require patient assistance during the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded.
It's now my pleasure to introduce your host Jean Marc Archie Light side Advisors. Please Mr. Qi 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 Teresa and Chief Financial Officer magnitude Duda and 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 six months ended June 30th 2023.
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 grandmothers 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 day of this live broadcast August 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 turn the call over to Sergio Sergio.
Yeah.
Thank you, Tim as always and good afternoon to everyone and welcome to the Red matter second quarter 2023 conference call.
I am pleased to report today that the ongoing phase III program for around 10 to 17 in major depressive disorder or M. D. D. He is proceeding as planned.
I will first provide you with you a brief update followed by a magazine view, our second quarter financial results.
We will take your questions.
As a reminder reminder, useful was on developing best in 17, as an adjunctive treatment for M D.
As previously communicated we have made critical changes to realize too young go in 302.
Three two arms placebo controlled pivotal studies evaluating rather than 17 at 25 milligrams for adjunctive M D D.
The amended study 302 protocols continues to be implemented across all of our clinical sites.
The protocol amendment had significantly lessen the burden to both subjects insight by reducing the required time span based subject at this time.
This was achieved by removing duplicative assessment and evaluation that we had all the exploratory interest you amended protocol Leverages about learning from the completed control controlled trials from the reliance development program and Optimizes the potential sort of reduction in the high placebo response seen in these compete.
These studies.
As enrollment continues.
Over the next several months. So we'll keep you updated on the trial progress we're planning to enroll approximately 300 patients and currently expect that reliance to study 302 to be completed in the first half of 'twenty 'twenty four.
Screening has commenced for the newly initiated trial study three O floor, which we named Relight.
It also has a planned enrollment of approximately 300 patients completion of this study is called you anticipate in the second half of 'twenty 'twenty four.
Like when I used to.
Realized he is a randomized double blind placebo controlled four week trial evaluating the efficacy and safety of routing 17, as an adjunctive treatment of MTT in patients experiencing inactivated response to ongoing background antidepressant treatment.
The primary end point of both studies is the same.
The change in the my dress total score from baseline to day 28 for relatives at 10 17 as compared to placebo.
Realize.
Is being designed to reduce the time spent that decides and emphasize the quality of patient enrollment.
We recently had successfully investigator meetings with participating sites for both phase III studies during the investigator meetings. Our team focuses on providing intensive training on topics, including appropriate subject enrollment data quality and strive to use for controlling placebo response and radio.
Yeah.
The open label one year safety study for rather than 17 studied 310 has concluded we'd get stuck with the attainment of the necessary long term safety exposure required for the purpose of the NDA filing and we expect these data to be available during the current quarter.
As we continue to execute on the phase three clinical development plan for El Pen 17, we also remain focused on further enhancing the plethora of published and presented data in support of our late stage product candidates.
To this end.
We will have a significant presence at several important scientific Congress is over the next few months, including the presentation of multiple posters, we expect to present two posters at the 36 and while E. C. N P Congress in October in Barcelona, among other scientific conferences in the second half.
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In addition residents 17 human abuse potential data were recently published in the peer reviewed journal translational psychiatrist.
Moving on Maggie will provide the details with you, although we're financially, but I would like to emphasize that RASM either remains sufficiently funded to fully execute our plans to reach data readouts for both phase III trials reliance you innovate.
I will now turn the call over to Maggie to review, our second quarter financial results Maggie.
Thank you Sergio today, we issued a press release announcing our business and financial results for the three and six months.
30th 2023 which have all now review.
For the second quarter ended June 32023 tell about research and development expense was approximately $13 $7 million as compared to $39 million for the comparable period of 2022 a.
A decrease of approximately $17 $17 $2 million. The decrease was primarily associated with it you shouldn't offer lines. One study 301 and relying treat studying 303 in late 2022.
Noncash charge related to stock based compensation totaled $1 $7 million in the most recently completed second quarter.
Total general and administrative expense for the second quarter ended June 32023 is approximately $12 $3 million as compared to $14 $6 million for the comparable period of 2022, a decrease of approximately $2 $3 million. The decrease was primarily driven.
And by a decrease in stock based compensation. This noncash charge totaled $9 $4 million in the most recently completed second quarter.
For the second quarter ended June 32023, and net loss was $25 $3 million or 84 cents per basic and diluted share compared to a net loss of $39 $9 million, one dollar and 33 cents per basic and diluted share in the comparable period of 2022.
Turning to the results for the six months ended June 32023, total research and development expense was approximately $29 $6 million as compared to $55 $9 million for the comparable period of 2022, a decrease of approximately $26 $3 million.
Again, the decrease was primarily associated with the completion of reliance one study 301 and reliance three study three of three in late 2022, and noncash charge related to stock based compensation totaled $3 $7 million in the most recently completed six months Perry.
For the six months ended June 32023, total general and administrative expense was approximately $24 $6 million as compared to $27 $9 million for the comparable period of 2022, a decrease of approximately $3 $3 million. The decrease was primarily driven.
And by a decrease in stock based compensation compensation. This noncash charge totaled $18 $8 million in the most recently completed six months period.
For the six months ended June 32023, and net loss was approximately $51 $6 million, one dollar and 72 cents per basic and diluted share compared with a net loss of $79 $7 million or $2 73 per basic and diluted share in the comparable period.
2022.
As of June 30, 2023 we had cash cash equivalents and short term investments of approximately $118 $5 million compared to approximately $148 $3 million as of December 31 2022.
Cash used in operations for the second quarter was $13 $3 million.
Based on our clinical development plan, our current cash position provides us with ample runway through the end of 2024.
This time period includes data Readouts from both phase III trials reliance to that study 302, and really that's starting three or four I will now ask the operator to please open the call for questions operator.
Thank you.
We will now be conduction a question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad, a confirmation Thorn we've indicated the airlines is the.
Question two.
You May press star two if he would like to have in both of your questions from the queue.
Or participants using speaker, we keep I mean, it might be necessary should be cut.
E R headset farfetched Stark please.
Our first question came from.
My good man.
Looking partner.
Please Sir go ahead.
Hi, This is Judy on the line from Mark. Thanks for taking my questions can you provide more color on the enrollment progress for study 302, and what keeps you the confidence that you can finish the study first half 'twenty four and also can you remind us the powering of the study 302 to four.
Yeah sure good afternoon, and thanks for the question and we do have a fabric of Gorman that is our chief Medical officer, who runs the all our development plans. So I think he is the most appropriate to answer. This question Cedric can you help.
Thanks, Sergio and I agree with you thanks for the questions.
With regards to enrollment we're targeting 50 sites for both approximately 50 for 302 and three or four and so our efforts have been focused on.
Engaging initiating and in making those sites active four for screening and enrollment. So we have seen an uptick and we previously let you know that we were above 100 subjects randomized into 302 study and we've seen an uptick in both screening and randomization in recent weeks and we'll give you an update.
Further on that once we have more numbers to share and wait three or four we are now actively screening I haven't got the first patient in yet, but so now we have two studies phase III adjunctive treatment of M. D D actively screening and enrolling.
We as regards to the power and we Havent shared powering.
Assumptions on trailing two or three or four at this point.
Got it that's very helpful. Just a quick follow up you mentioned that you had hosted investigator meetings recently, just curious what feedback you've got from your investigators regarding your new protocol.
Yeah go ahead yeah.
Oh, sorry, sorry, yeah, yeah yeah.
Yes, it's we held both remote but also in person investigator meetings and.
Certainly the feedback from the sites, where there has been.
A real gratitude and appreciation that people are able to get back and attend in person meetings, which are I think are really much more education and illustrative and the feedback on the streamlined our mandates for your two protocol as well as the new if you like.
Dreamland streamlined from from the beginning three or four protocol has been really positive both in terms of the feedback from the P is the study coordinators at the site level through these meetings that we've engaged with them on but also we've had the opportunity for subjects to already randomize.
Under the current amended protocol, Ontario, too and we've heard directly from sites that it's moving much more efficiently swiftly and no hiccups. So it's going it's going very well from a.
From a scale assessment perspective, and from a data entry perspective, I'm very pleased with the feedback.
Got it very helpful. Thanks.
Thank you.
Our next question games film.
And Andrew Tsai Jefferies. Please Sir go ahead.
Hi, all this is a J for Andrew.
Thanks for taking my question. My first one is on a possible interim scenario. So I guess first of all what an interim look be possible.
So.
When would that occur and what could those outcomes look like and then I have a follow up.
Yeah, sorry, yeah.
I couldn't hear the first part so the first question is about the interest.
First first question is just what an interim readout.
Or some sort of interim look be possible got it yeah I got it yes, okay.
I believe it's for you as well.
Thanks, Sergio and thank you for the question yes.
Yes, an interim analysis is certainly possible we've looked at various scenarios of what we might consider doing that we have included in the protocol and opportunity to do that as well, but in terms of giving granular detail at which point and what that interim what SaaS, we haven't we haven't disclosed that yet.
Got it got it Okay and then my second question would be on the drug effects for 2017 so.
At 10, 17 has shown a pretty consistent Madras reductions across the studies, though.
Is there a reason to believe that the efficacy and are aligned to an alliance for could be even larger than what we saw in <unk>, one and three.
Saturday.
I wanted to try and then eventually it will.
Pick it up.
Go ahead.
But I was just waiting for you to to ask me to answer that but yeah. No absolutely I think that you are you're right a J M.
In terms of the change.
The address from baseline to end point, we've consistently seen them at 15 to 17 point change on the Madras and you'll remember in the phase two.
Yeah, the effect size was 0.7 or above.
Schedule, you looked at and in the 301 and the three of three studies completed towards the end of last year. Obviously, it was hampered by a high placebo response, the order of 13 or 14 point change in the mattress 13 in the adjunctive three a 114 in the monotherapy of three or three <unk>.
Vast majority of the placebo change occurred in the first week of both those studies and so you're absolutely right. We believe that if we brought on a high quality well controlled study where we.
We we try and limit the effects of expectation bias for subjects on placebo response, we could we could we could more align and get closer to what we've observed in phase two so we're hopeful that if we are if we do control placebo response, and we believe we have the right sites and we're now enrolling them.
Patients that have documented medical records confirming their diagnosis and were out of the pandemic. There's a lot of different variables here, but we believe that yes.
And the ideal scenario well conducted trial youll see something closer to what we previously observed in the positive phase two.
Got it so it sounds like the underlying assumptions here or keep the debt.
The drug.
In fact, the same but lowered the placebo.
Yeah, the drug effect has been a consistent yeah.
Got it okay. Thank you very much.
Okay.
Yeah.
Okay.
Our next question is from <unk> <unk> with Guggenheim.
Hi, this is not enough Milwaukee, thanks for taking our question.
This accomplishment.
About 30 lifestyle.
If the pound at one point it would be nicer. If that's four weeks six weeks and he said disgusted. So typically we get yeah, which feedback is there yes.
And then I would just like to confirm if you know what it costs that are on clinical trials, that's called the information about that.
Thank you so much.
Yes, sure Cedric do you I am very high demand today. So I think you should take this one as well.
Yeah No no problem. Thank you for the question and so with regards to relight, yes. The primary endpoint in both the reliance one in real life is.
It's the for a four week a change in the mattress total score from baseline drug versus placebo and of course, that's important to keep that consistent. So that you can replicate the findings are when it comes to determining efficacy and as with all our aspects.
Aspects of what we do.
And the R&D team and in our clinical trial design, we discuss everything but the F. D. A to make sure that our approach is appropriate and supported so.
That is correct and in terms of posting the records on clinical trials that will be eminent and and within the the expectations for compliance from a regulatory perspective with postings there so you'll see that shortly.
Thank you.
Our next question is from Andrea <unk> with Goldman Sachs.
Good afternoon. Thanks for taking my question Cedric, maybe I'll stick with you and ask you one here I'm just curious on the back of the F. D. A C. R. L first Iran alone for M. D. D. Just curious if that changes anything in terms of how you're thinking about or approaching reliance too and the related study and then I have a second question.
Hi, Andrew Thanks.
Yeah. Thanks, Andrzej answered you.
I don't think it really changes anything I mean.
You know these studies were designed with FDA and put all the way along.
And so we know what the FDA is looking for when it comes to developing an M D T drug.
Once daily Adjunctive agent and I also think that you know our drug if approved would be once daily treat an add on.
There's a lot of them.
History and precedent for how how one should develop these drugs to get approval.
And I think that it's our mode of administration and chronic ongoing treatment.
Is is quite.
Traditional as opposed to maybe some newer agents, which have a different type of.
We're a pure like approach.
So I wasn't I'm, we're not particularly our we don't feel that there's any influence at the C or the F. D. A C O L or is there an alone are impacting what we are doing.
Got it and then can you also speak to what needs to be done ahead of the open label study reading out and any updated thoughts on the extent of data that will be shared.
Yeah.
Yeah, we're very excited sorry search yes, no no no go ahead go ahead.
Yeah.
Yeah, I was just going to say I don't say that we're very excited about I thought had announcing these data I'm of course when a when a study locks then you just go through what's the.
The extensive <unk>.
<unk> of our issuing queries to sites cleaning the data, making sure that everything is accounted for in that you have a nice clean package and then you obviously deliver it to the statisticians, who do their analysis and compute.
The outputs and and and the various things that you like to see when they are actually presented when we present the top line. So as a reminder.
We have fulfilled the the I C H guidelines around drug exposure for safety and Tolerability. The open labor was a one year study so what that affords us is not only the required overall 1000 subjects exposed 100 for 12 months.
300 subjects at least for six months, but also over time, you'll be able to see a picture of how open label, which sort of corresponds with real world treatment.
How are patients managed to improve.
The near term and then sustain their improvement in the Madras score and in their depressive symptoms out over the course of 12 months. So we look forward to sharing those data.
Both from the efficacy perspective, and also then safety and Tolerability, which will give you a nice picture of what we believe are low.
Rates of adverse events and really good continuation in the end the trial so.
Everything has been done it's a matter of us as we announced.
Basically disclosing the results later this quarter.
Got it thanks, so much guys.
Thank you then.
Ladies and gentlemen, we have reached the end of the question and answer session.
Like to turn the call back to Sergio traversing for closing comments.
Thank you. Thank you Murray.
In summary, we remain confident that we have an approvable drug.
Did we have the right plan and team in place to achieve success. So we look forward to reporting on progress, we'd rely as true and rely throughout the remainder of the year.
In closing I do remain grateful to the realm of the team for their continued hard work and dedication to executing on our mission I also would like to extend my sincere thanks to the patients and clinical partners involved in the Rose 10, 17 trials for their participation in the advancement of these promising investigational med.
As seen through development. Thank you very much to everyone and I wish everybody a good end of the day.
Thank you. This concludes today's conference you may disconnect your lines at this time.
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