Microvast Q3 2023 Earnings Call Transcript

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Provided by Quartr
November 8, 2023

There are 8 speakers on the call.

Operator

Ladies and gentlemen, and welcome to the Relmata Therapeutics, Inc. 3rd 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. This call is being recorded on Wednesday, November 8, 2023.

Operator

I would now like to turn the conference over to Tim McCarthy of LifeSci Advisors. Please go ahead.

Speaker 1

Thank you, operator, and thank you all for joining us this afternoon. With me on today's call are Chief Executive Officer, Sergio Traversa Chief Financial Officer, Magha Choudhita and Doctor. Cedric O'Gorman, Chief Medical Officer. This afternoon, Ramada issued a press release providing a business update Announcing financial results for the 3 9 months ended September 30, 2023. Please note that certain information discussed on the call today is covered under the Safe Harbor We caution listeners that during this call, Ramada's management team will be making forward looking statements.

Speaker 1

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, 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 8, 2023. Ramada undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this conference call. Now I would like to turn the call over to Sergio.

Speaker 1

Sergio?

Speaker 2

Thank you, team, as always, and good Good afternoon to everyone, and welcome to Ramada Third Quarter 2023 Conference Call. We have achieved some important clinical milestone recently in the ongoing Phase 3 program for rel=ten seventeen In a major depressive disorder, MDD, as well as in our promising preclinical novel psilocybin program That I will briefly cover today. Following this, Magal will review the 3rd quarter financial results and then we will take your questions. Let's begin with an update on the Phase 3 program for rel=ten seventeen, We'd continue to proceed as planned. As a reminder, BRAMARA is focused on developing REL1017 As an adjunctive treatment for MDD, as previously communicated, we have made critical changes to Reliance II, the ongoing ResN-seventeen, 25 milligram for adjunctive MDD.

Speaker 2

The amended STU-three zero two protocol has been implemented across enrollment is progressing as we leverage our close relationship With the study sites and the number of ongoing initiatives to drive prior awareness with prospective patients. As a reminder, we are planning to enroll approximately 300 patients and continue to expect that Reliance 2 Will be completed in the first half of twenty twenty four, most likely toward the end of the first half, so around media. In the 2nd Phase 3 trial of REL-ten seventeen named RELITE or Study 304, We begin dosing patients during the Q3. RELITE also has a planned enrollment of approximately 300 patients. Completion of enrollment in this trial continues to be anticipated in the second half of twenty twenty four.

Speaker 2

To reiterate what we have said previously, like Reliance, Reliance is a randomized, double blind, Placebo Controlled 4 Week Trial Evaluating Efficacy and Safety of Rel10 17 is an adjunctive treatment The primary endpoint of both studies is the same. The change in the MADRAS total score from baseline to day 28 for rel=seventeen as compared to placebo. Also, during the Q3, we announced efficacy and safety results From the open label 1 year safety study for rel1017, the Study 310 or 310. These long term safety exposure data are required for the purpose of the NDA filing. More specifically, in September, we shared efficacy result for the 204 De novo or new to treatment patients and safety results for all 627 study subjects.

Speaker 2

Study REL1017 310310 was a long term open label, non comparative open label Registration of Phase 3 trial designed to evaluate the efficacy and safety of rel=ten seventeen administered 1 daily in patient with MDD for up to 1 year. I will now reiterate some of the previously communicated results in the de novo patients. Rapid and sustained improvement in madras score were served in with rel=ten-seventeen in the de novo patient and The entire study population. As the de novo patient reflect a more reliable picture of the real world condition, I will highlight the de novo patient results. The mean MADRA score total score was 33 Point 8 at baseline.

Speaker 2

Treatment with REL-ten seventeen in this patient resulted in mean improvement from baseline in the MADRAS total score of 16.8 points at month 1, 19.9 points at month 3 And 6 and 22.5 points at month 12. High rates of clinical response, Both rapid and sustained were seen in de novo patients. When treated with rel=ten seventeen in the madras total score at day 7, 26.6 patient of the de novo patient achieved clinical response. It is defined as the greater than or equal to a 50% improvement in the MADRAS score, which increased to 51% by month 1 and 77.2% by month 12. Virtual absence of depressing symptoms or clinical remission was achieved by 12.1% of the de novo patients at day 7, which increased to 30.1% at month 1, And then again, 54.4 percent at month 12.

Speaker 2

Clinical remission is defined as the MADRAS total score of less 10 or equal to 10. In summary, patients treated daily with rel=ten seventeen for up to 1 year experience a rapid, Clinically meaningful and sustained improvement in depressive symptoms and associated functional impairment. Importantly, the overall matters change and response and remission results in study REL-ten seventeen-three ten For the de novo patient and the full analysis set, we are consistent in both groups. For all the REL1017-three ten Subjects relative to 17 was well tolerated with long term dosing, showing low rates Adverse events and discontinuation due to adverse events. No new safety signals were detected.

Speaker 2

Moving now to our promising preclinical novel modified release siloside B program. At next week or this weekend AASLD meeting, the new data will be presented in a poster presentation. The data demonstrate the beneficial effect of non psychedelic low dose On multiple metabolic parameters in a rodent model of metabolic dysfunction associated Theatotic liver disease or MASLD. As a reminder, they are not currently Approved drugs for MAL, SMB. And these initial preclinical results support the therapeutic potential in none of non psychedelic low dose psilocybin.

Speaker 2

Based on these data, non psychedelic low dose psilocybin could improve lipid and glucose levels with potential for fewer side effects over other investigative treatment approaches such as the GLP-1s. We intend to initiate a single ascending dose Phase 1 trial in obese patients with steatotic liver disease in early 2020 To define the pharmacokinetics safety and tolerability profile of our modified release psilocybin formulation in this population, followed by a Phase IIa trial in the same patient population to establish Moving on, Magette will provide a detailed review of our financials. But I would like to emphasize that RENATA remains sufficiently funded to fully execute our plans to reach data readouts for both REL-ten seventeen Phase 3 trials, RELANZ II and RELYSE. I will now turn the call over to Magit to review our second Quarter financial results. Megan?

Speaker 3

Sure. Thank you, Sergio. Today, we issued a press release announcing our business and financial results For the 3 9 months ended September 30, 2023, which I will now review. For the Q3 ended September 30, 20 23. Total research and development expense was approximately $10,500,000 as compared to $30,500,000 For the comparable period of 2022, a decrease of approximately $20,000,000 The decrease was primarily associated with the completion of RELIANCE 1, that's Study 301 and Reliance 3, Study 303 in late 2022.

Speaker 3

The non cash charge Total general and administrative expense for the Q3 ended September 30, 2023 was approximately $12,200,000 As compared to $8,200,000 for the comparable period of 2022, an increase of approximately $4,000,000 The increase was primarily driven by an increase in stock based compensation. This non cash charge totaled $9,600,000 in The most recently completed Q3 net cash used in operating activities for the 3 months ended September 30, 2023 totaled $11,600,000 compared to $26,900,000 for the 3 months ended September 30, 2022. For the Q3 ended September 30, 2023, the net loss was $22,000,000 or $0.73 per basic and diluted share, compared with a net loss of $39,400,000 or $1.31 per basic and diluted share in the comparable period of 2022. Turning to the results for the 9 months ended September 30, 2023, total research and development expense was approximately 40,100,000 As compared to $86,500,000 for the comparable period of 2022, a decrease of approximately $46,400,000 Again, the decrease was primarily associated with the completion of RELIANCE I Study 301 and RELIANCE III Study 303 in late 2022. The non cash charge related to stock based compensation totaled $5,500,000 in the most recently completed 9 month period.

Speaker 3

For the 9 months ended September 30, 2023, total general and administrative expense was approximately $1,000 The increase was primarily driven by an increase in stock based compensation. This non cash charge Total $28,500,000 in the most recently completed 9 month period. Net cash used in operating activities For the 9 months ended September 30, 2023, totaled $41,400,000 compared to $67,900,000 For the 9 months ended September 30, 2022. For the 9 months ended September 30, 20 Net loss was approximately $73,600,000 or $2.45 per basic and diluted share Compared to a net loss of $119,100,000 or $4.04 per basic and diluted share in the comparable period of 2022. As of September 30, 2023, we had cash, cash equivalents and short term investments of approximately $106,300,000 compared to approximately $148,300,000 As of December 31, 2022, again, cash used in operations for the Q3 was $11,600,000 Based on our clinical development plan, our current cash position provides us with ample runway through the end of 2024.

Speaker 3

Of note, this time period, as Sergio mentioned, includes data readouts from both Phase 3 trials, RELIANCE 2, That's Study 302 and Relight, that's Study 304, as well as the initiation of our planned Phase 1 trial for our modified release Stylosibin formulation. And I'll turn the call over now to the operator.

Operator

Thank you. Ladies and gentlemen, we will now begin the question and answer session. One moment please for your first question. Your first question comes from Marc Goodman, Leerink Partners. Marc, please go ahead.

Speaker 4

Hi, good afternoon. This is Basma on for Mark. Congratulations on the quarter. I have a question regarding the RELIANCE OLS study. With this study conducted at the same sites as Reliance 1 and Reliance 3, and I also have a question about The MD Reliance 1 and Reliance 3, regarding the patient characteristics, can you remind us again about The average age of the participants after you looked at the data, after you unblinded the data, and have you noticed any correlation between the In accurate diagnosis of MTT and the age of the participants?

Speaker 4

Thank you.

Speaker 2

Great. Well, thanks for the question. I do believe that Cedric, our Chief Medical Officer, is the most appropriated to address them. Cedric?

Speaker 5

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's offered. So therefore, yes, the sites that were part of RELIANCE 1 and RELIANCE 3 also had the opportunity to be part of the open label

Speaker 2

study and contribute subjects to

Speaker 5

that long term study. Subject to that long term study. Remember, there was a question then about the average age and These studies are run-in adults 18 to 65 years of age. And of course, you know that Major depressive disorder is represented at a 2:one ratio in females than males. We haven't looked at age Breakdown, there's lots of interesting analysis that we will do, but I can't comment on a correlation or outcomes by age.

Speaker 5

But the average age was probably in the area of the 40s or 50s.

Speaker 4

Got it. Thank you so much.

Speaker 2

Thank you.

Operator

Thank you. Your next question comes from Yui Ihir, Mizuho. Yui, please go ahead.

Speaker 5

Hi. This is Charles on for Oi. I guess I kind of had a follow-up Question to that, if there was any other read throughs from the open label de novo patients to the Phase 3 studies? And then also if you saw a difference between the adjunctive And monotherapy patients from that open label? Thanks.

Speaker 2

Thanks, Charlie. Sergio here. Let me try to give you a little bit more like top down and then Cedric can go more in detail. And so learning, look, the Long term safety study is 12 months and we look at the MADRAS improvement data and the conclusion are Simple, but significant and material because this represent real world 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 3 months 12 months.

Speaker 2

And The sustained, so there is no loss of efficacy over time, and the safety has confirmed that the drug is extremely safely and well Tolerated. So these are really the key learning in a real world experience. So the answer or the question to There is a difference in adjunctive and monotherapy. In the 12 month study, it's not really like Very significant to make a difference. It was not the it's a mix.

Speaker 2

So it's very it would be unfair to separate Monotherapy from adjunctive because we don't know, right, in 12 months where people do that. Somebody take medication, they Stop them, somebody doesn't take them. So it would not be a reliable information. Though, I mean, we look at the De novo and the overall population that come from the 2 Phase 3 studies, it's over 500, 600 patients. There is really no difference that would be Ramada.

Speaker 2

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 work well or they work extremely well. It's pretty consistent and that make us comfortable because it's a real world experience. Cedric, do you want to add anything to my remarks?

Speaker 5

I think you said it all. Just to confirm what you said that there's this consistent improvement trajectory with rapid onset The de novo are the it's the ideal group to look at when you're looking at efficacy in the open label because that study isn't as well controlled as our placebo controlled Trials on who gets in. So there's a lot of subjects and you don't and a lot of commonant medications that they're on. So it's quite a mixed bag, but one thing is consistent. Lee 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 CONTROL trials.

Speaker 5

Thanks so much. Thanks for taking my question. Thanks,

Speaker 2

Josh.

Operator

Thank you. Your next question comes from Andrew Tsai, Jefferies. Andrew, please go ahead.

Speaker 6

Hi. Thanks so much. This is Dina on for Andrew. We just had a couple of quick questions. What are each of your 2 Phase 3 studies sort of power to show in terms of major separation versus placebo?

Speaker 6

And A question for Cedric. Operationally speaking, how can you say with high confidence The study integrity for the 2 Phase 3 studies in 10/17 are similar to how Axsome's successful studies were run. Are you seeing a lot of similarities

Speaker 2

Yes. Thanks, Adena. Maybe Serge should answer that. Maybe I just would like to try to answer your last question, right, on the comparison with Axsome. And Cedric runs both the trials, running our trial and run Axon trial, but these are very, very, very different drugs.

Speaker 2

So I don't know how much would be reliable To compare the 2 programs and Cedric, do you want to try to answer?

Speaker 5

Sure. Yes. No, I think that anybody who's in the drug development space, Particularly in major depressive disorder, very much tries to run as high quality program as possible. And that really comes down to 3 things, the protocol, the site selection and subject selection. And so it doesn't matter which sponsor you work for, you want to have a very tight, Efficient protocol that aims to reduce placebo response.

Speaker 5

And then you want to work with the best sites that are Conducting MDD trials. And of course, those of us who work in clinical research for depression know that there are Always the same sites known to the sponsors. You would expect that there would be Knowledge and familiarity because these sites are the best in major depressive disorder. And then you just have to very carefully I have an eligibility process that makes sure that you're avoiding that you're getting the right patient with confirmed diagnosis of MDD and you're avoiding professional patients. And you're doing everything from a subject selection process as well that might minimize Recruiting or enrolling patients or subjects, I should say, who may be prone to having a high placebo response.

Speaker 5

So you do that across the program. And I have to say that I'm very pleased with how rigorous our eligibility process is in letting Subjects into the trial. And the question on the statistical powering, we haven't actually revealed that yet. So I mean, Yes. It would be reasonable to if you take the Phase 2 data and If you were to consider 301 or 303 where placebo was controlled to about 10 or 11 points improvement on the MADRS, you could probably Figure out how we're powering it because we are targeting approximately 300 subjects as Sergio mentioned at the beginning.

Speaker 5

So I hope that helps a little bit with an answer to your question.

Speaker 2

And then if I can add just one quick point, According to the KOLs and the history literature, a difference in MADRAS score versus placebo is 2, 2.5 points is considered Clinically meaningful and enough for approval. So you may imagine that we will file the statistical plan In according to these parameters, so the statistic will be set up to detect a Madras difference from placebo that is clinically meaningful and good enough for approval. Hope I answered properly your question.

Operator

Thank you. Your next question comes from Yatin Suneja, Guggenheim. Yatin, please go ahead.

Speaker 7

Hi. This is Belma for Yatin. Thanks for taking my question. So I have few questions on the psilocybin program. I just wanted to ask you, if you have already 5, the IND for the Phase 1 trial?

Speaker 7

And how many doses are you planning to use there? Are there any of This tool is expected to 3 get a second at this time. Thank you.

Speaker 2

Yes. Sorry, I answered the first it's Sergio here. 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 IND. We are on the process To prepare the IND and I do believe will be filed relatively soon, but we are planning to start the Phase 1 Single dose ascending in Q1 next year, so let's say 2, 3 months from now.

Speaker 2

Can you please repeat the second part?

Speaker 7

Yes, sure. I was just asking if you have noticed how many doses you are planning to test there? And if any of these doses expected to trigger a psychedelic experience?

Speaker 2

How many doses? No, we haven't finalized the exact dose regimen we'll discuss in the IND. But what 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 in the history and from other programs that are ongoing. They're using 20 milligrams, 25 milligrams in a single dose and we will use 1 tenth of that. So we It's a fair assumption that the dose we'll be using will not be toxic or Not well tolerated in general term, but the dose limiting toxicity we are trying to determine is when You start to have psychopimetics, psychological, psychiatric or psycho symptoms, I put it in this way, when you start to feel That the drug is affecting your side.

Speaker 2

So we are developing a low dose extended release That is non psychedelic. So the dose limiting toxicity will be the psychedelic effect. We don't know exactly what the dose is, but we It will be like below 3, 4 milligrams daily.

Speaker 7

Okay. Thank you.

Operator

Thank you. There are no further questions at this time. Please proceed.

Speaker 2

Well, thank you. Look, in summary, we remain confident that we do have an approval drug in RAL1017, And we are excited about the potential of the novel silosibing and derivative programs. We look forward to reporting the progress With our pipeline in the months ahead, and I do remain grateful to the Ramada team for their continued hard work and dedication to executing on our mission. I would like to extend my sincere thanks to the patients and clinical partners involved in the RAS1017 trials for their participation in the advancement of this promising investigational Matt is in totally open. Thanks a lot to everyone, and we'll reconnect soon.

Operator

Thank you. Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.

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