Guaranty Bancshares Q2 2023 Earnings Call Transcript

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August 8, 2023

There are 9 speakers on the call.

Operator

Greetings, and welcome to the Ramada Therapeutics Inc. 2nd Quarter 2023 Earnings Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded.

Operator

It's now my pleasure to introduce your host, Tim McCarthy, LifeSight Advisors. Please, Mr. Thiem, 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 Traverza and Chief Financial Officer, Magda Chenuda 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 6 months ended June 30, 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.

Speaker 1

We caution listeners that during this call, Braumada's management team will be making forward looking statements. Actual results could differ materially from those stated or These forward looking statements are qualified by the cautionary statements contained in RealMata'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 day of this live broadcast, August 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, Tim, as always, and good afternoon to everyone, and welcome to the Ramada Second Quarter 2023 conference call. I am pleased to report today that the ongoing Phase 3 program for rel 10/17 in major depressive disorder, MDD, is proceeding as planned. I will first provide With you a brief update followed by Maga's review of our Q2 financial results and then we will take your questions. As a reminder, Ramada is focused on developing ResDent17 as an adjunctive treatment for MDT. As previously communicated, we have made critical changes to Reliasur, the ongoing 302, A Phase 3 true arm placebo controlled pivotal study evaluating rel1017 at 25 milligrams For adjunctive MDD, the amended study 302 protocol continues to be implemented across all our clinical sites.

Speaker 2

The protocol amendment had significantly lessened the burden to both subject and site by reducing required This was achieved by removing duplicative assessment and evaluation that were of exploratory interest. And optimizes the potential for reduction in the high placebo response seen in these completed studies. As enrollment continues over the next several months, we will keep you updated on the trial progress. We are planning to enroll approximately 300 patients and currently expect that RELIANCE 2 Study 302 to be completed in the first half of twenty twenty four. Screening has commenced for the newly initiated trial, Study 304, which we named RELITE, that also has a planned enrollment of approximately 300 patients.

Speaker 2

Completion of this study is currently anticipated in the second half of twenty twenty four. Like RELIANCE 2, RELIGHT is a randomized, double blind, placebo controlled 4 week trial Evaluating the efficacy and safety of REL-ten seventeen as an adjunctive treatment of MDD in patients experiencing inadequate The primary endpoint of both studies is the same, The change in the MADRAS total score from baseline to day 28 for reltez1017 as compared to placebo. ReLite has been designed to reduce the time spent at the sites and emphasize the quality of patient enrollment. We recently had successful investigator meetings with participating sites for both Phase 3 studies. During the investigator meetings, our team focused on providing intensive trading on topics including appropriate subject enrollment, Data quality and strategies for controlling placebo response and rater training.

Speaker 2

The open label 1 year safety study for rel=ten seventeen, study 310 has concluded with the attack with the attainment of the necessary long Thank you. Thank you. Our next question comes from the line of David. Thank you. Thank you.

Speaker 2

Our next question comes from the line of David. As we continue to execute on the Phase 3 clinical development plan for rel1017, we also remain focused on further enhancing the We will have a significant presence at several important scientific congresses over the next few months, including the presentation of multiple posters. We expect to present 2 posters at the 36th Annual ECNP Congress in October in Barcelona, among other scientific conferences in the second half of 2023. In addition, REL1017 human abuse potential data were recently published in the peer reviewed journal Translational Psychiatry. Moving on, Magal will provide a detailed review of our financials, but I would like to emphasize that Ramada remains sufficiently funded to fully execute our plans To reach data readouts for both Phase 3 trials, RELIANCE 2 and BRIDLIGHT.

Speaker 2

I will now turn the call over to Magit to review our Q2 financial results. Magis?

Speaker 3

Thank you, Sergio. Today, we issued a press release Announcing our business and financial results for the 3 6 months ended June 30, 2023, which I will now review. For the Q2 ended June 30, 2023, total research and development expense was approximately $13,700,000 as compared to $30,900,000 for the comparable period of 2022, a decrease of approximately Study 301 and RELINE Study 303 in late 2022. The non cash Charge related to stock based compensation totaled $1,700,000 in the most recently completed second quarter. Total general and administrative expense for the Q2 ended June 30, 2023 was approximately $12,300,000 As compared to $14,600,000 for the comparable period of 2022, a decrease of approximately $2,300,000 The decrease was primarily driven by a decrease in stock based compensation.

Speaker 3

This non cash charge totaled $9,400,000 the most recently completed Q2. For the Q2 ended June 30, 2023, the net loss was $25,300,000 or $0.84 per basic and diluted share compared to a net loss $39,900,000 $1.33 per basic and diluted share in the comparable period of 2022. Turning to the results for the 6 months ended June 30, 2023, total research and development expense was approximately $29,600,000 as compared to $55,900,000 for the comparable period of 2022, a decrease of approximately $26,300,000 Again, the decrease was primarily associated with the completion of RELIANCE-one Study 301 and Reliance 3, Study 303 in late 2022. The non cash charge related to stock based compensation totaled $3,700,000 in the most recently completed 6 month period. For the 6 months ended June 30, 2023, $27,900,000 for the comparable period of 2022, a decrease of approximately $3,300,000 The decrease was primarily driven by a decrease in stock based compensation.

Speaker 3

This non cash charge totaled $18,800,000 in the most recently completed 6 month period. For the 6 months ended June 30, 2023, the net loss was approximately 51 point were $2.73 per basic and diluted share in the comparable period of 2022. As of June 30, 2023, we had cash, cash equivalents and short term investments of approximately $118,500,000 compared to approximately $148,300,000 as of December 31, 2022. Cash used in operations for the 2nd quarter was $13,300,000 Based on our clinical development plan, our current cash position provides us with ample runway through the end of 2024. Of note, this time period includes data readouts from both Phase III trials,

Operator

Thank you. We will now Our first question comes from Mark Goodman, Leerink Partners. Please sir, go ahead.

Speaker 2

Hi, this is Shudi on the line for Mark. Thanks for taking my questions. Can you provide more color on enrollment progress for Study 302? And what gives you the confidence that you can finish this study in first half twenty twenty four? We do have Cedric O'Gorman that is our Chief Medical Officer that runs the all development plan.

Speaker 2

So I Cedric, can you help?

Speaker 4

Thanks, Sergio, and hi, Rudy. Thanks for the questions. With regards to enrollment, we're targeting 50 sites for both approximately 50 for 302304. And so our efforts have been refocused on engaging, initiating and making those sites active for screening and enrollment. So we have seen an uptick and we previously let you know that we were above 100 subjects randomized in the 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.

Speaker 4

And with 304, we are now actively screening, haven't got the first patient in yet, but so now we have Two studies, Phase III, adjunctive treatment of MDD actively screening and enrolling. We As regards to the power, we haven't shared powering assumptions on 302 or 304 at this point.

Speaker 2

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 investigators regarding your new protocol?

Speaker 2

Nick, go ahead, Cedric.

Speaker 4

Yes. Sorry, Sergio. Yes. Yes, it's we have both remote but also in person Investigator meetings. And certainly, the feedback from the sites has been Our real gratitude and appreciation that people are able to get back and attend in person meetings, which I think are really much more educational and illustrative.

Speaker 4

And the feedback on the Streamlined amended 302 protocol as well as the new, if you like, streamlined From the beginning, 304 protocol has been really positive, both in terms of the feedback from the PIs and 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 subject to already randomized under the current amended protocol on 302, and we've heard directly from sites That it's moving much more efficiently, swiftly and no hiccups. So it's going very well From a scale assessment perspective and from a data entry perspective, I'm very pleased with the feedback.

Speaker 2

Got it. Very helpful. Thanks.

Speaker 4

Thank you.

Operator

Our next question comes from Andrew Tsai, Jefferies, please sir, go ahead.

Speaker 5

Hi, all. This is A. J. For Andrew. My first one is on a possible interim scenario.

Speaker 5

So I guess, first of all, would an interim look be possible? And if so, When would that occur and what could those outcomes look like? And then I have a follow-up.

Speaker 2

Yes, sorry, Ajay. I couldn't hear you the first part. So the first question is about the interest?

Speaker 5

First question is just, would an interim readout or some sort of interim look be possible?

Speaker 2

I got it. Yes, Cedric, I believe it's for you as well.

Speaker 4

Thanks, Joe, and thank you, Ajay, for the question. Yes, an interim analysis is certainly possible. We've looked at various scenarios of when we might consider doing that. We have included in the protocol an opportunity to do that as well. But in terms of giving granular detail at which point And what that interim would assess, we haven't disclosed that yet.

Speaker 5

Got it, got it. Okay. And then my second question would be on the drug effects for 10/17. So 10/17 has shown a pretty consistent, mattress reductions across the study. So Is there a reason to believe that the efficacy in Reliance 2 and Reliance 4 could be even larger than what we saw in Reliance 1 and 3?

Speaker 2

Cedric, why don't you try and then eventually I will Piyitab, if I have anything to add?

Speaker 4

Yes. No, I was just waiting for you to ask me to answer that. But Yes. No, absolutely. I think that you're right, Ajay.

Speaker 4

In terms of the change on the From baseline to endpoint, we've consistently seen a 15 to 17 point change on the MADRS. And you'll remember In the Phase II, the effect size was 0.7 or above depending on which scale you looked at. And in the 301 and the 303 studies that 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 MADRS, 13 in the adjunctive 30114 in the monotherapy of 303. The vast majority of the placebo change occurred in the 1st week of both those studies. And so you're absolutely right.

Speaker 4

We believe that if we We're on a high quality, well controlled study where we try and limit the effects of We could more align and get closer to what we've observed in Phase 2. So we're hopeful that if we do control placebo response and we believe we have the right sites and we're now enrolling Appropriate patients that have documented medical records confirming their diagnosis And we're out of the pandemic. There's a lot of different variables here, but we believe that, yes, in the ideal scenario, well conduct Trial, you see something closer to what we've previously observed in the positive Phase 2.

Speaker 5

Got it. So it sounds like the underlying assumptions here are keep the drug effect the same, but lower the placebo?

Speaker 4

Yes, the drug effect has been consistent. Yes.

Speaker 5

Got it. Okay. Thank you very much.

Speaker 2

Thank you.

Speaker 6

Our next question is from Yatin Suneja with Guggenheim.

Speaker 7

Hi, this is Velma for Yatin. Thanks for taking our question. So just a couple from us. About the RELITE study, Can you clarify if the primary endpoint will be measured at 4 weeks or 6 weeks? And if you discuss the protocol with the FDA, which feedback Did you hear from them?

Speaker 7

And then I would just like to confirm if you already post on clinicaltrials dot gov any information about the relight study?

Speaker 2

Yes, sure. Cedric, you are in very high demand today. So I think you should click this one as well.

Speaker 4

Yes. No problem. Thank you for the question. And so with regards to RELITE, Yes, the primary endpoint in both Reliance 1 and Relight is the 4 week Change in the MADRS total score from baseline drug versus placebo. And of course, that's important to keep that consistent so that you can replicate the Findings when it comes to determining efficacy.

Speaker 4

And as with all aspects What we do as part in the R and D team and in our clinical trial design, we discuss everything with the FDA and make sure That our approach is appropriate and supported. So that is correct. And in terms of posting the records on clinicaltrials dot That will be imminent and within the expectations for compliance from a regulatory perspective with postings there. So You'll see that shortly.

Speaker 7

Thank you.

Speaker 6

Our next question is from Andrea Tan with Goldman Sachs.

Speaker 8

Good afternoon. For taking my questions. Cedric, maybe I'll stick with you and ask you one here. Just curious on the back of the FDA CRL for zuranolone for MDD, just curious if that Changes anything in terms of how you're thinking about or approaching Reliance 2 and the RELITE study? And then I have a second question.

Speaker 4

Hi, Andrea. Thanks. Yes. Thank you, Andrea and Sergio. The I don't think it really changes anything.

Speaker 4

I mean, 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 MDD drug, once daily, adjunctive agent. And I also think that our drug, if approved, would be a once daily treatment add on. There's a lot of History and precedent for how one should develop these drugs to get approval. And I think that it's Our mode of administration and chronic ongoing treatment is quite Traditional as opposed to maybe some newer agents, which have a different type of Therapeutic approach, so I wouldn't we're not particularly we don't feel that there's any influence at The FDA CRL for ziranalone impacting what we are doing.

Speaker 8

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

Speaker 4

Yes, we're very excited sorry, Sergio, sorry.

Speaker 2

No, no, go ahead. It's Yes.

Speaker 4

I was just going to say, Andrew, that we're very excited about announcing these data. Of course, when a study locks, then you just go through what's the extensive process of Issuing queries to sites, cleaning the data, making sure that everything is accounted for and 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 the various things that you like to see when they're actually presented when we present the top line. So as a reminder, we have fulfilled the ICH guidelines around drug exposure for Safety and Tolerability, the open label was a 1 year study. So what that affords us is not only the required Overall, 1,000 subjects exposed, 100 for 12 months, 300 subjects at least for 6 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 patients managed to improve in the near term and then sustain Their improvement in the MADRIS 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 Sure.

Speaker 4

What we believe are low rates of adverse events and really good continuation in the trial. So Everything has been done. It's a matter of, as we announced, basically disclosing the results later this quarter.

Speaker 8

Got it. Thanks so much guys.

Speaker 2

Thank you, Ben.

Speaker 6

Ladies and gentlemen, we have reached the end of the question and answer session. I would like to turn the call back to Sergio Traversa for closing comments.

Speaker 2

Thank you. Thank you, Maurizio. So in summary, we remain confident that we have an approvable drug, That we have the right plan and team in place to achieve success. So we look forward to reporting on progress with Reliance II and Reliance throughout In closing, I do remain grateful to the Ramada 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 ResNet-seventeen trials for their participation in the advancement of this promising investigational medicine through development.

Speaker 2

Thank you very much to everyone and I wish everybody a good end of the day.

Speaker 6

Thank you. This concludes today's conference. You may disconnect your lines at this

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