Q3 2024 Anavex Life Sciences Corp Earnings Call - Q&A
Clint Tomlinson: Good morning and welcome to the Anavex Life Sciences Fiscal 2024 third quarter conference call. My name is Clint Tomlinson, and I will be your host for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session. During the session, if you would like to ask a question, please use the Q&A box or raise your hand.
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Clint Tomlinson: Fiscal 2024 third quarter Conference call. My name is Clint Tomlinson and I will be your host for today's call.
Speaker Change: At this time all participants are in a listen only mode. Later, we will conduct a question and answer session.
Speaker Change: During this session if you'd like to ask a question. Please use the Q&A box or raise your hand.
Clint Tomlinson: Please note this conference is being recorded and the call will be available for replay on Anavex's website at www.anavex.com. With us today is Dr. Christopher Missling, President and Chief Executive Officer, and Sandra Boenisch, Principal Financial Officer.
Speaker Change: Please note. This conference is being recorded and the call will be available for replay on <unk> website at Www Dot <unk> Dot com.
Christopher <unk>: With us today is Dr. Christopher <unk>, President and Chief Executive Officer.
Sandra Burnish: And Sandra Burnish principal.
Sandra Burnish: Principal financial Officer.
Clint Tomlinson: Before we begin, please note that during this conference call, the company will make some projections and forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. We encourage you to review the company's filings with the SEC. This includes, without limitation, the company's Forms 10-K and 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking standards.
Speaker Change: Before we begin please note that during this conference call. The company will make some projections and forward looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. We encourage you to review the company's filings with the SEC. This includes without limitation, the companys forms 10-K and 10-Q.
Speaker Change: Which identify the specific factors that may cause actual results or events to differ materially from those described in these forward looking statements. These.
Clint Tomlinson: These factors may include, without limitation, risks inherent in the development and or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights.
Dr. <unk>: These factors may include without limitation risks inherent in the development and commercialization of potential products uncertainty in the results of clinical trials or regulatory approvals need and ability to obtain future capital and maintenance of intellectual property rights and with that I'd like to turn the call over to Dr. <unk>.
Clint Tomlinson: And with that, I'd like to turn the call over to Dr. Missling. Thank you.
Christopher Missling: Thank you, Clint, and good morning, everyone. Thank you for being with us today to review our most recently reported financial results and to provide our quarterly business updates. We continue to meaningfully advance our differentiated precision medicine clinical program, highlighted by the recent presentation of comprehensive results from the phase 2b slash 3 clinical trial, Blacamezine, Anavex 273, presented at the Alzheimer's Association International Conference, AAIC, showing that oral, once daily Blacamezine significantly slowed clinical decline in early Alzheimer's disease.
Christopher Missling: Patients with a good comparative safety profile and associated neuroimaging adverse events. Full data from the Black-Carmesian Study in Alzheimer Disease Phase 2b-3 placebo-controlled clinical trial will be published in an upcoming peer-reviewed journal. The initiated process for submitting a marketing authorization application, MAA, to the European Medicine Agency, EMA, under the centralized procedure is underway, with full regulatory submission of flaccarmazine expected in Q4 of 2024. The marketing authorization would allow direct market access throughout the European Union for oral glaucamazine for the treatment of Alzheimer's disease.
Christopher Missling: There are an estimated 7 million people in Europe with Alzheimer's disease, a number expected to double by 2030, according to the European Brain Council. Analysis of RNA sequencing, RNA-Seq, which would reveal which genes are actively transcribed, or in other words, expressed in ultima patients, in comparison between placebo and blackamizine after a placebo-controlled phase 2b-3 blackamizine trial in early Alzheimer's disease is underway. This data might have relevant value since it may provide insight into Alzheimer's disease pathology and how cells function in the presence of placebo or in the presence of lacamizine, respectively. Inframed data is expected in the second half of 2034.
Christopher Missling: In June, we completed the last patient's last visit in the ATTENTION-AD Open Label Extension 96-week trial. Interim data from this trial is expected in the second half of 2024. The recent AAIC24 meeting resulted in constructive feedback coupled with enthusiasm around our Alzheimer's disease program, strengthened by the recent addition of an experienced clinical team that supports Anavex's future plans. Educational outreach will continue as we work towards MAA submission and beyond. We are also pleased to report that the clinical team continues to meet the planned timelines in the ongoing Phase II clinical trial of Anavex 371 in schizophrenia patients.
Dr. <unk>: <unk> team continues to beat the planned timelines in the ongoing phase two clinical trial of INO 371 in schizophrenia patients.
Christopher Missling: We have completed dosing in the first cohort and are nearing the completion of enrollment in the second cohort of schizophrenia patients in Part A of the trial. In Parkinson's disease, initiation of Anavex 273, phase 2b, stage 3, an over six month trial, including biomarkers, which we believe may be key for understanding drug effects on Parkinson's disease pathology and account for the recently changing context in the field of Parkinson's disease, is expected in the second half of 2024. In Rett Syndrome, an educational presentation was provided at the 2024 IRRVETS Rett Syndrome Scientific Meeting, going from June 18 to June 19, 2024, which demonstrated the commitment of IRVETS to the Rett Syndrome community.
Dr. <unk>: We have completed dosing of the first cohort and are nearing the completion of enrollment of the second court of schizophrenia patients in part a of the trial.
Speaker Change: In Parkinson disease initiation of <unk>, two <unk> three phase II <unk> III, a over six months trial, including Biomarkers.
Speaker Change: Which we believe may be key for understanding drug effect on Parkinson disease pathology and account for the recently changing context in the field of ultimate of Parkinson's. This is expected in the second half of 2024.
Speaker Change: In Ret syndrome, and occasional presentation was provided at the 'twenty to 'twenty four IRS.
Speaker Change: Ret syndrome scientific meeting going from June 18 to June 19, 2024, which demonstrated the commitment of <unk> to the Ret syndrome community.
Speaker Change: Through direct engagement with patients and families.
Speaker Change: Positive and supportive feedback was received from families and investigators about the continued analytics Ret syndrome program.
Speaker Change: Regarding fragile X new disease specific translatable and objective biomarker data generated with analytics with Tim three.
Speaker Change: Supporting the initiation of the <unk> two <unk> three phase two phase.
Christopher Missling: Our cash position at June 30th was $138.8 million, and we have no debt. During the quarter, we utilized cash and cash equivalents of $5.2 million in operating activities after taking into account changes in non-cash working capital.
Christopher Missling: Thank you, Sandra.
Sandra Boenisch: from
Sandra Boenisch: Thank you for the question. There's only the focus right now on the email submission, which takes a lot of resources. We have to submit and put together a package of many modules, which can be so many pages and documents.
Sandra Boenisch: So we focus on that. But the time will come. We don't know yet when to also meet regulatory bodies around the world, including the agency in this country as well.
Christopher Missling: Okay, with regards to the recent presentation at the AAIC of the phase 2B3 data, the question comes up with regard to varying number of patients included in different measures that the company presented. And I have assumed that you, it's just simply due to the fact that you can't force patients in the trial to come in and take certain tests, especially more invasive ones, and that this explains it. And of course, the dark side likes to claim cherry picking. So can you discuss this aspect and put the issue to rest, you know, as to whether you do anything with the data that's given?
Speaker Change: Claim cherry picking so can you discuss this aspect and put the issue to rest you know as to whether you do anything with the data that's given.
Speaker Change: May I understand they're not to talk about the number of patients in each visit.
Speaker Change: Schedule a visit.
Speaker Change: In the different things like card 13 in.
Speaker Change: And whatever that you presented to the AIC.
Speaker Change: The number of physicians about 70 points.
Speaker Change: Do you anticipate pipeline yeah.
Speaker Change: Yeah, so the <unk>.
Speaker Change: So this is a.
Speaker Change: No.
Speaker Change: By the way you explained it that every patient does not always prison.
Speaker Change: Present at the time point in question.
Speaker Change: He can skip he can be impaired because of COVID-19 and just travel during COVID-19. It's very normal to you just have to then.
Speaker Change: Always account for when you have a data point and Thats exactly described in the presentation.
Speaker Change: And when you look at other papers from.
Speaker Change: Auto home from the economy do not let them up they are exactly the same every number is different at every time point because they are not always the same amount of Ah patients attending the visit so that's a.
Christopher Missling: So-called, you know, the $150 million stock offering that the various news reports on.
Christopher Missling: X, was there a phase one?
Christopher Missling: the tolerability of the patients for the first doses, the lower dose and a higher dose subsequently. And the second higher dose is now almost completed enrollment. And Part B will be a longitudinal study run for about 28 days or so. So the drug will be given at the dose which will be considered the best tolerated dose, and we will then observe patients over a longer period of time. So the-
Christopher Missling: Good morning, everyone, and thank you for taking the question and also congrats on executing on multiple fronts. On the AIC data, Alzheimer's disease, could you give us a little color, make us understand on the dose dependency or the clear lack of dose dependency between 30 milligram and 50 milligram? There was ADAS-CoG was working a little better for the 50 milligram versus CDRLP for the 30 milligram. And the discontinuation rate, are you so what percent of the 50 milligram did you see had to scale back to 30 milligram because of adverse events in the open label extension?
Speaker Change: We are in a compassionate use program, where this extremely high intolerance.
Christopher Missling: with allowing patients to titrate to 50 or 30, as long as they have enough time to do that, and then also taking nighttime dosing. So we don't see the adverse events we have seen in this trial because we basically forced them to titrate so quickly up to the target dose. And we also have to point out that it's actually a manifestation of a manageable and addressable adverse event. It's not like when you look at brain bleeding or brain swelling from the antibodies, which we don't have, that no matter how you take the drug, you always will have 30 or more percent of patients with that very dangerous side effect of a drug, of an antibody, which we don't have.
Speaker Change: With allowing patients to titrate to a 250 or 30 as long as they have enough time to do that and then taking also nighttime dosing. So we don't see the adverse events. We have seen in this trial, because we basically forced them to titrate, so quickly up to the target dose.
Speaker Change: And we also have to point out that it's actually a clearly manifestation of a manageable.
Speaker Change: And addressable adverse event, it's not like when you look at brain bleeding of brain swelling from the antibodies, which we don't have that no matter. How you take the drug you always will have 30 or more percentage of patients with at a.
Speaker Change: Very.
Speaker Change: Dangerous side effects of a drive of an antibody, which we don't have but in our case to it.
Christopher Missling: But in our case, the adverse event of dizziness is a manageable one because it just depends on the titration schedule. And that can be flexible, and changed. And that's what we will now, of course, do in the future.
Speaker Change: Adverse event of dizziness is a manageable one because it just dependent on the titration schedule and that can be flexible.
Speaker Change: Change and that's why we know we'll of course do in the future.
Christopher Missling: So that's the answer to your question. And also, needless to say, that we are also acknowledging that, and we've heard that from physicians, that the dizziness sign, again, not all patients had that. We also have to put this in perspective, that it's a sign that shows penetration in the brain and shows that something's happening in the brain. Also, one last point I'd like to make is that this dizziness lasted really relatively short for those patients who had it.
Christopher Missling: It was sometimes between seven to 11 days on average. So it's a very mild form of dizziness, so it's a very easy to address situation, but it shows up in this trial because, again, we forced patients to go to these high doses very quickly, and we learned the lesson that we can avoid that.
Christopher Missling: Yep, so let us first put the data together, but once we have it, we will make a decision. But all your suggestions could be valid recommendations.
Clint Tomlinson: Thank you, and congratulations again on the progress.