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spk05: As of June 30th, 2022, our cash and cash equivalents were $105.7 million compared to $133.5 million at December 31st, 2021. Our goal is to continue to be prudent with how we manage our cash and our expenses. And we believe that our cash and cash equivalents will be sufficient to meet our operating requirements beyond our key development milestones in 2023 and into 2024, which is well over 18 months of cash runway based on our current budget. Finally, I wanted to mention that earlier in the month, the Board of Directors approved a ratio of 1 for 15 reverse share split of the company's common shares. The reverse share split is intended to enable us to achieve several important corporate objectives by providing greater flexibility in considering and planning for future potential business needs and to address the NASDAQ minimum price bid requirement. The reverse share split is expected to take effect after the close of business on August 26, 2022, with the trading expected to begin on a split-adjusted basis for the NASDAQ and the NEO exchanges at market open on August 29, 2022. I'll now turn the call back over to Rob, who will provide some closing comments. Rob?
spk02: Thank you, Sean.
spk06: As we've demonstrated, the second quarter was marked by steady progress across our development pipeline. But equally as important, we made some key decisions on our corporate strategy and focus that I believe will drive increased success and efficiency. We have a highly talented and committed team here at MindMed who have continued to execute this plan. Our near-term priorities are clear. Advancing the Ongoing Clinical Trials of MM120 in GAD and ADHD. Commencing our Phase 1 Clinical Trial for MM402 in Healthy Volunteers in 2023. And through our collaboration with UHB, initiating a Phase 1 Comparative Pharmacokinetics and Pharmacodynamic Trial of RS and Racemic MDMA in Healthy Volunteers in the third quarter of 2022. Finally, I want to note that we are aware of the letter issued earlier today by SCM MM Holdings. Unfortunately, SCM chose not to directly contact us about their views before issuing the letter. That was disappointing because we are always open to feedback from our shareholders. Nevertheless, we would be receptive to engaging in a constructive dialogue with SCM if they are interested. We're still reviewing their letter and do not plan to address it on this call. Therefore, we ask that your questions be limited to our second quarter updates and the progress of the business that we've discussed today. With that, I'd like to thank you all again for being here today and happy to take any questions.
spk03: If you would like to register a question, please press the one followed by the four on your telephone and you will hear a three-tone prompt to acknowledge your request. If your question has been answered and you would like to withdraw your registration, please press the one followed by the three. If you're using a speakerphone, please lift your handset before entering your request. Once again, that's one four to register for a question. One brief moment for the first question. We have a question from Charles Duncan with Kantor Fitzgerald. Please go ahead, your line's open.
spk07: Okay, thank you. Hi, Rob and team. Congratulations on the progress and completion of that strategic review. And to Sean, congrats on joining the MindMed group. Had a couple of questions, primarily on 120. I guess I'm wondering if you could provide a little bit more color, Rob, on the GAD study. Nice to see that you plan to dose the first patient, but can you give us a little bit of sense of the number of clinical sites that you plan to initiate over the course of the near term, and then whether or not those patients that you'll be enrolling in the GAD study are experienced with LSD or not?
spk06: Yeah, thanks so much for the question, Charles. In terms of the clinical design for MM120 and GAD, as you know, we are conducting a five-arm parallel clinical trial in this indication, and we have 200 patients across the entire study. We're enrolling at 20 sites here in the U.S. as our target number of sites, and we anticipate to get many of those sites online in the very near term. Given some of the controlled substances requirements to activate clinical sites, using a Schedule I controlled substance and clinical research studies. That can vary by jurisdiction, by state, and by the local DEA office, but we've been working feverishly in the background with each of the sites to get their applications together and anticipate getting many of the sites online in the very near term.
spk07: Okay, and then I think he used the words up to 200 patients to be enrolled in that study. I may have misheard that, but If I did hear it correctly, could you let us know what would determine the total sample size, the final sample size?
spk06: The target sample size is 200 patients. Obviously, there's some final variance that's possible in those numbers, plus or minus a few patients, simply based on the end of the study enrollment, but we're targeting and
spk02: anticipate enrolling the full 200 patients in that study.
spk03: Our next question is from the line of Elmar Piros with Roth Capital Partners. Please go ahead. Your line's open.
spk01: Yes. Hi. Rob, just one question on the anticipated 20 sites. I saw one of them is listed on clinicaltrials.gov. Is there any more? Is there maybe a delay? with the listing on that website, or they are coming on as we speak, so they're just not in the system yet?
spk06: Absolutely. There's no delay. All the sites are coming online, and it's just a matter of when those sites are posted on clinicaltrials.gov.
spk01: Okay. And could you please also just a little bit elaborate on your decision not to directly invest in MM110 at this stage, what brought that decision or what precipitated that decision, if you wouldn't mind?
spk06: Absolutely. As I mentioned, we had a productive engagement with FDA. We were exploring opportunities to pursue that program in a number of jurisdictions. But as we previously announced, we were intent on advancing that program into phase two, subject to those discussions with FDA. Based on those discussions, it was clear that we needed to do additional non-clinical research in order to support an adequate dose and duration in the treatment of opioid withdrawal, and therefore decided that the time and cost requirements to bring that product forward at this time needed to be allocated to our other programs. That said, we, of course, see value and potential in this program, and at the appropriate time in the future, we'll reevaluate moving forward into a Phase II program.
spk03: Our next question is from Patrick Trucchio with HC Wainwright. Please go ahead. Your line is now open.
spk00: Thanks. Good afternoon. Just a couple of follow-up questions from me. I guess just the first one, if you could remind us in the LSD Phase IIb trial, What are the doses that are going to be evaluated of LSD, and would the low dose or would a subperceptual dose be expected to act as the control in this trial?
spk06: Yeah, thanks so much, Patrick. So the doses we're testing, in addition to a placebo, are 25 micrograms, 50 micrograms, 100 micrograms, and 200 micrograms of LSD. Those correspond to different levels of perceptual activity, after acute administration of LSD. One of the great things about this study is it will enable us to do post hoc pairwise comparisons between each of those dose levels. One of the things we feel has been inadequately explored with the psychedelics is the dose response of this both acutely and in terms of durability of effects across this dose range. So we will certainly be looking at the potential of all of these doses to impart either rapid or prolonged clinical benefit. But we'll also be looking at the comparisons between the dose such as 25 milligrams compared to the 200-microgram or 100-microgram dose to determine if there are differences in terms of placebo response or functional unblinding between those doses.
spk00: Yeah, that's helpful. And then as well in this Phase IIb trial, can you talk about Are there any requests or is there anything from the regulators on the safety and tolerability side that would need to be generated or that you would be looking for beyond kind of what we would normally look to see in a Phase 2b trial? And what would you need to see from kind of an efficacy and safety perspective to give confidence to move this program forward to Phase 3?
spk06: Yeah, in terms of safety endpoints, they're largely aligned with both what you would expect from any CNS-active molecule that's in Phase II development. There is, obviously with LSD, there's a history of clinical research, and where there are any observations from historical literature, we certainly pay special attention there, but there's nothing that would stand out as particularly unique or not ordinary about the safety endpoints we're studying in the trial. Patrick, your second part of the question, I believe. Do you mind repeating the second part of your question there?
spk00: Yeah, just in terms of, you know, in terms of the improvement that you're looking for on the primary endpoint and kind of what would give you confidence to kind of move this program forward to phase three, would you be looking for kind of what was just demonstrated in the UHP trial or, you know, kind of similar you know, outcome as well as kind of a clear kind of dose response, or what would you want to see here from efficacy as well as safety to move forward to Phase 3?
spk06: Yeah, we have not given guidance on the specific cutoffs for what we'd anticipate to move forward. Certainly, we would anticipate and expect and would want to see a dose response compared from top doses or from any of the doses to a placebo. So we are certainly looking for a clinical response in this study and obviously we're always shooting to have a statistically and clinically significant result. Based on the results from the UHB study and from historical literature, we're quite confident that that outcome is going to be achieved and certainly we'll analyze those data and try to pass forward based on the outcomes of the study.
spk03: Our next question is from separate Mano cherry with a capital piece. Go ahead. Your lines open.
spk04: Good afternoon. Thanks for taking my question. My first question is on the, from the lead program you guys have as your focus. I understand there's a phase two a happening for MM one 20 that started in December with the kind of two arms, I think 26 stations per arm. Do you have visibility on where that enrollment is and I guess what that cadence has been like? Has it picked up in the last couple months? And yeah, just give us a little bit of insight into that.
spk06: Yeah, enrollment has progressed according to plan and we remain on track to have a readout in the later part of 2023 in that study. We don't typically announce enrollment figures for any of our clinical studies along the way while they're in progress, but certainly believe at this stage that everything is on track for that clinical readout that we've guided to the second half of next year.
spk04: Got it. So that's kind of past that startup phase and has started to dose patients. Just kind of distinguishing from the GAD study, which is right now on the ramp up before dosing, can you give us an insight into what the lead-in time was for before dosing in that study, and if that's informative for this one?
spk06: Yeah, they're quite different study designs in different population populations, so we're certainly with them as somewhat discreet in terms of how we approach it. That study is actively dosing patients and is ongoing.
spk04: Got it. Okay, well, that's great to hear, and obviously great to see the cost reduction and the forward-looking cost reduction efforts. When you guys talk about non-dilutive funding, do you have insight and have you gotten kind of line of sight into opportunities or whether it's co-development partnerships or government grants? I understand I believe the National Institute of Health Research has in the past funded some programs that align with the MM110 program. Can you kind of touch on that?
spk06: Yeah, we're open to exploring all non-dilutive sources of capital, and we'll be exploring those as we progress here. We certainly aren't in a position today to say that we have one that we are going to be advancing with, but we keep our options open to us, and we'll continue to explore them to try to pass forward for that program.
spk03: And I believe we have a follow-up question from Charles Duncan with Cantor Fitzgerald. Please go ahead. The line's open.
spk07: Hi, Rob. Thanks for taking the follow-up. I wanted to ask you about 402, a program that we haven't talked much about on this call so far. Intrigued with that, I guess I'm wondering if you can provide us a little bit of color on the IP behind it, as well as in terms of, I think you mentioned a study looking at R and then S. and then also racemic, and I'm wondering what you anticipate being able to learn from that study.
spk06: Yeah, thanks so much, Charles. We're very excited about this program and the potential it has. As you know, there are no available therapies in the treatment of the core symptoms of autism spectrum disorder, and so this would really represent a first-in-class position if we're ultimately successful in the approval of this program. In terms of the study that we'll be starting very soon, it is, as you said, a comparative PK-PD study between the two enantiomers of MDMA and racemic mixture. One of the things we're particularly interested in is observing the on-drug prosocial and perceptual effects. MDMA is not a serotonergic psychedelic such as LSD, so we see more serotonergic activity with the RN-antimer. But to observe functionally and subjectively what patients, experiences on the drug. While autism is certainly a disorder that is defined in the DSM, we believe that the on-drug effects that would be present in normal healthy volunteers may have carryover effects that would give us confidence to move forward in the ASD population. So we're certainly very keen on understanding the pharmacodynamic and subjective effects of RMDMA in a treatment session. In terms of intellectual property, we have filed and will continue to file patents across our entire portfolio. We feel quite confident in our strategic approach, both with patent and non-patent intellectual property protection. And as those applications are further prosecuted and become published, we'll certainly be happy to talk further about them and where we see the claims.
spk07: Okay. And can I assume that you'll be conducting those studies in adults first? And then do you have any plans to consider rare neurodevelopmental disorders in which ASD is a prominent symptom in adults or even younger people? I suppose that's a stretch.
spk06: We certainly do anticipate to begin our clinical research program in adults, but this is a disease that is developmental and is diagnosed in early childhood. Over the longer term, we certainly have a path charted where we anticipate moving into pediatric indications if the data support it ultimately. We keep our minds open as well to subtypes of any of the diseases. And if there are rare pediatric or rare adult diseases that would align with the prominence of any of these symptoms or autism spectrum disorder in itself, we would certainly take every opportunity to explore them as part of the development program at some point.
spk07: Okay, very good.
spk02: Thanks for taking the follow-up. Absolutely. Thanks so much. And I believe that's all the time we have for questions today.
spk03: That concludes the Q&A portion of the call. I will now turn the call back over to MindMed CEO, Rob Barrow, for closing remarks. Rob?
spk06: Thank you, Operator, and thank you, everyone, who joined us this afternoon. Before we conclude today's call, I'd also like to thank the entire MindMed team, our investors, and to the many people who have been supportive along the way, including our study participants and their families.
spk02: That concludes the call for today. We thank you for your participation. As I say, please disconnect your line.
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