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spk08: Good day and thank you for standing by. Welcome to the ADEX Therapeutics to announce full year 2022 financial results and provides corporate update conference call. At this time all participants are in listen only mode. After the speaker's presentation there will be the question and answer session. To ask a question during the session you need to press star 1 1 on your telephone keypad. You will then hear an automated message advising your hand is raised. To withdraw your question please press star 1 1 again. To ask a question via the webcast, please access the Ask a Question tab. Please be advised that this conference is being recorded. I would now like to hand the conference over to our first speaker today, Tim Dyer. Please go ahead.
spk06: Hello, everyone. I'd like to thank you all for attending 2022 Full-Year Financial Results Conference Call. I'm here with Robert Lugens, our Head of Discovery Biology. I draw your attention to the press release and the financial statements issued earlier today, which are available on our website. I also draw your attention to our disclaimer. We will be making certain forward-looking statements that are based on the knowledge we have today. I will start this conference call by giving a quick overview of our recent achievements before handing over to Robert, who will review our clinical and preclinical pipeline I will then review our 2022 full-year financial results. Following that, we will open the call for Q&A. Our partner, Janssen Pharmaceuticals, continued to make excellent progress in executing their Global Phase II study in epilepsy patients with ADX 71149. 71149 is part one of the study and progressed to part two. An independent interim review committee has been established by Janssen to review the data from part one and make a recommendation on the future direction of the study. We expect to announce the recommendation from this independent interim review committee early in Q2 this year. We continue to believe there is value in Dip for Glorant and have substantially completed our evaluations of future development. We have identified post-stroke recovery and pain as interesting areas for future development in addition to PD-LID. However, we are currently pursuing collaborative arrangements to advance future development. We continue to be excited by our preclinical pipeline, which has made excellent progress with multiple clinical candidates rapidly advancing towards IND-enabling studies. We've selected a drug candidate in our mGluR7-NAMM program for stress-related disorders, including post-traumatic stress disorder, and are progressing this drug candidate into IND-enabling studies. We expect to start dosing in these studies in the second half of this year. We also continue to progress several backup compounds from differentiated chemicals in the candidate selection phase. We have made substantial progress in our collaboration with our partner Indivior in advancing several novel GABA-B PAM compounds into clinical candidate selection. As a reminder, Indivior's primary interest is in substance use disorder, and under the agreement, we have retained the right to select drug candidates for development in certain exclusive reserved indications, including Charcot-Marie-Tooth 1A neuropathy, chronic cough, and pain. During 2022, We extended our collaboration with Indivior, and Indivior agreed to provide us with additional research funding of $1.8 million. We expect Indivior and ourselves to select compounds to advance into IND enabling studies in early 2024. Our mGluR2 NAMM program for mild neurocognitive disorders associated with Alzheimer's disease, Parkinson's disease, and depression ran into some challenges during clinical candidate selection phase. So we've gone back into lead optimization. Last but not least, our M4PAM program for schizophrenia continues to make rapid progress through lead optimization. M4PAM is a particularly exciting target for schizophrenia, especially following the recent positive phase 3 data from Karuna. Following the inconclusive data from our blepharospasm clinical study and the termination of dipreglans development in PD-LID due to slow recruitment rate attributed to COVID-19 pandemic-related constraints, we have completed the close down of the studies and implemented a number of cost-saving measures. These cost-saving measures have significantly reduced our monthly cash burn going forward And as of today, we estimate that our cash reserves provide us with a runway through the end of Q3 2023 and enough time to secure a partnership to strengthen our balance sheet and provide resources to advance our portfolio. Now I will hand over to Robert, who will give you some more details about our exciting pipeline. Thanks, Tim. Hello, Robert.
spk07: I will start by saying that we are very excited about the opportunity to work with you.
spk03: As a reminder, 71149 is a metabotropic glutamate receptor, subtype 2, or mGlu2, positive allosteric modulator discovered in partnership with Janssen Pharmaceuticals. a Johnson & Johnson company using ADEX's proprietary allosteric modulator platform. Janssen have extensively profiled ADX7149 in preclinical models of epilepsy and have demonstrated both standalone antiepileptic efficacy and a strong synergistic effect in combination with Keppra. There is a large market opportunity as more than 2 million patients are taking Keppra and many have breakthrough seizures or a suboptimal response. Furthermore, despite several available treatment options, and many patients of alternative or improved therapies to treat the seizures. Interestingly, Keppra, while being largely sold as a generic, is still leading the market of anti-epileptics with close to one billion sales revenue per year. Janssen have completed an extensive preclinical and clinical package and are currently running both a phase two study and an open label extension study in epilepsy patients. It is important to note we have significant economics in our deal with Janssen. We have prelaunch milestones of 109 million euros, low double digit royalties on net sales, and Janssen are responsible for all costs. Now, I would like to show you some of the preclinical data. I mentioned the synergistic effect obtained in preclinical models of epilepsy. Here is the compelling data obtained by our Janssen colleagues in the 6 Hertz model, a highly predictive model of epilepsy, with a combination of 7.19 and Keppra, and which has been instrumental in the decision taken by Janssen to move this program into epilepsy. The left graph shows how the effect of levothyroxetine is dramatically increased in presence of a low dose of 71149, producing a 35-fold shift in efficacy. And the right graph shows the result obtained when the paradigm was reversed, where a low dose of Keppra induces a 14-fold increase in efficacy of ADX 71149. The take-home message here is that we see a strong anti-epileptic effect with a combination of low doses of 7-1-1-4-9 and Keppra, similar to the one obtained with a full dose of Keppra. This is truly a synergistic effect, not just an additive or pharmacokinetic effect, as demonstrated through isobolographic analysis. This is because of the diversity in the patient regions. If models translate into patients, then our approach could become an important novel treatment for epilepsy patients suffering focal onset seizures. Now to the Phase II study design. This is a Phase II double-blind, placebo-controlled, proof-concept study and is enrolling patients with focal-concept seizures who have suboptimal response to treatment with Levitiracetam, which I remind is the active substance of Kefra, or Breviracetam. Patients will establish a 28-day seizure count over a 56-day baseline period prior to being randomized to receive either ADX 71149 at 50 milligrams twice a day or matching placebo. The primary endpoint is the time taken to return to their monthly baseline seizure count. The study has two parts, part one being the four-week acute efficacy phase and part two being an eight-week maintenance of efficacy phase. Part two will include patients who did not reach their baseline seizure count during part one of study. and they will continue on their randomized drug or placebo. Janssen plan to recruit up to three cohorts to test multiple doses of 71149. Today, one of 60 patients have completed part one of the study. Janssen have established an independent interim review committee to look at the data from part one and issue recommendation for the future conduct of the study in early Q2 2023. We look forward to sharing their recommendation as soon as it is available. And now on to Depraglurant, our mGlu5 negative allosteric modulator. I'd like to mention that the field of mGlu5 negative allosteric modulators is very active, with two molecules, Mavoglurant and Vazimglurant, which are progressing in clinical trials, demonstrating this mechanism of action is safe and well tolerated. Mavoglurant, discovered by Novartis, is being developed by Stelicla in cocaine use disorder with a strong financial and scientific support from the U.S. National Institute for Drug Abuse. And Bezimgluant discovered by Roche is progressed by Noema Pharma in trigeminal neuralgia. While these indications could be interesting for Dipraglurant, we believe the differentiated profile of Dipraglurant is particularly suitable for dyskinesia associated with Parkinson's disease or PD-LID, and post-stroke recovery. We are currently working with key opinion leaders to establish the future development plans in PD-LID and post-stroke recovery. In parallel, we are pursuing collaborative arrangements to implement these future clinical plans. Let me now update you on our preclinical programs. We have made significant progress in advancing our preclinical programs. As a reminder, all our programs were identified in-house from our proprietary allosteric modulation discovery platform. The success of our platform is driven by the combination of our unique small molecule chemical library and tailor-made proprietary biological screening tools and methods which we deploy to identify the initial hits and support lead optimization. I would like to share with you the progress we have made in four of our most advanced proteolytical programs the GABA-B positive allostatic modulator, the MGLU7 negative allostatic modulator, the MGLU2 negative allostatic modulator, and the M4 positive allostatic modulator programs. Starting with our GABA-B positive allostatic modulator program, which is partnered with Indivio. The aim of this collaboration is to deliver treatment for substance use disorders. Indivio is supporting the research at ALEKS and have recently committed additional funding for us to complete clinical candidate selection activities, reaching 13.8 million Swiss francs total funding so far. As a reminder, GABA-B receptor activation has been clinically validated in a number of disease using Baclofen, a GABA-B orthostatic agonist. Baclofen is FDA approved for treatment of spasticity and is widely used off-label to treat numerous diseases including chronic cough, Charcot-Marie-Tooth 1A, and various types of pain. However, Baclofen has a short half-life and comes with significant side effects hampering its wider use. Thus, there is a strong need for a better Baclofen. We believe that it can be achieved with positive allostatic modulators and their differentiated pharmacology, having the efficacy of baclofen but longer half-life and improved side effects. We are well on our way to meeting this objective with multiple novel drug candidates rapidly advancing through clinical candidate selection phase with the aim to nominate drug candidates for IND enabling studies in 2024. As part of our agreement with Intivio, we have the right to select drug candidates from the funded research activities for our own independent Gharabi positive allostatic modulator program. I will now speak about the indications we plan to pursue. Firstly, Charcot-Marie-Tooth disease type 1a, or CMT1a, which is a type of inherited neurological disorder affecting the peripheral nervous system. It is caused by a duplication of the PMP22 gene, which leads to the production of the PMP22 protein. The excess of this PMP22 protein damages the myelin sheet that surrounds and protects nerve fibers, resulting in slow and progressive damage to the nerves. People with this disease experience weakness and wasting of the muscles of the lower limbs beginning in adolescence. Later, they can also have hand weakness and sensory loss, resulting in a significant reduction in their quality of life. CMT1A is the most common subtype of Charcot-Marie-Tooth disease, accounting for about 70% of cases. And there is currently no approved drug to treat CMT1A. However, Baclofen has shown beneficial effects in patients. In addition, we have collected robust preclinical data with Agarabipam, in highly translation models of CMT1A, demonstrating positive effects of chronic treatment on both biomarkers and behavioral measures, suggesting GABA-B PAM has the potential to slow or even stop the progression of the disease. There is also a strong rationale for developing GABA-B PAMs for chronic cough. Chronic cough is a persistent cough that lasts for more than eight weeks and can be caused by a variety of factors, including respiratory, sorry, infections, asthma, allergies, and acid reflux, but also possibly because of an overactive cough reflex. Support for this approach comes from validation with Baclofen used off-label in several categories of chronic cough, and from expression in the neuronal pathway involved in cough. Therefore, we believe that GERA-B PAMs could be an innovative new treatment of chronic cough, offering improved efficacy, fewer non-responder patients, and lack of gustatory side effects in comparison to P2H3 inhibitors. We are currently progressing our proprietary compounds and disease-relevant models of chronic cough. Another indication we're highly interested in is pain. GERA-B receptor activation has been well-validated by GERA-B which has shown efficacy in patients with cancer pain and is used off-label in patients with bladder pain or trigeminal neuralgia. Current medication is largely based on opioids, gabapentin and pregabalin, NSAIDs for bladder pain, or carbamazepine and other anti-epileptic drugs for trigeminal neuralgia. These medications are suboptimal as they leave a significant proportion of patients without bladder pain or even and to carry the risk of significant side effects. Here again, we strongly believe in an approach using Agarabee positive iris type modulator, which we expect to be highly efficacious without the side effects reported for current medications. Here also, we are working with multiple compounds, progressing a late clinical candidate selection phase, and we expect to move into IND-enabling studies in 2024, in parallel to delivering compounds for our partner, Indivio. We have made significant progress with our MP7 negative elastic modulator program for stress-related disorders, including post-traumatic stress disorder, as we have now selected a clinical candidate drug to enter IND-enabling studies and have identified several differentiated backup compounds. We have established a wide intellectual property position, ensuring a strong protection for our program. PTSD is a psychiatric disorder affecting approximately 3.5% of the population and may occur in people who have experienced or witnessed traumatic or life-threatening events such as a serious accident or a disaster or war. Current treatments rely mostly on behavioral therapy, as most pharmacological treatments such as anxiolytics and antidepressants show insufficient benefits. The rationale for inhibiting Mglu7 receptors as an approach for treating stress-related disorders, including PTSD, is based on a wide body of preclinical evidence from the anxiolytic profile of Mglu7 knockout or knockdown animals to studies using Mglu7-negative allostatic modulators performed at addicts, but as well as in many other groups. We have completed a robust preclinical package with our lead drug candidate and are now moving into IND-enabling studies and expect to enter Phase I studies in second half of 2024. On to our mGlu2-negative allostatic modulator program for mild neurocognitive disorders, or MNCD, and depression. MNCD is an age-increase expected to come with a decline, but not normal age and non-mNCD signs of dementia. Besides being potentially the early sign of Alzheimer's disease, MNCD is also often experienced by patients suffering from depression. Even patients that do respond to antidepressant treatment continue to suffer from MNCD, which significantly affects the quality of life. Developing MGRU2 negative out-of-state modulators offers the exciting opportunity to treat cognitive impairment while also addressing symptoms of depression. Both pro-cognitive and antidepressant effects have been demonstrated in relevant preclinical models with our mGlu2 negative allostatic modulator candidate compounds. We're completing lead optimization of our series and expect to begin clinical candidate selection phase with multiple compounds by end of this year with the aim to start IND-enabling studies in 2024. And finally, a few words about our Mucerinic M4-positive allosteric modulator program for treatment of schizophrenia and other types of psychosis. As I've told you, we've been pleased to present a collection of questions for the last 50 years with limited efficacy and significant tolerability issues, often leading to treatment discontinuation and relapse. The big news in the field came from Karuna Therapeutics, who recently published the positive results of their third Phase III registrational study of their CAR-XT compound in schizophrenia patients and who are on track to submit a new drug application to FDA by mid-2023. CAR-XT is a combination of xanomeline, a muscarinic M4 receptor agonist, and trospium, a peripherally restricted muscarinic antagonist. This combination allows to selectively activate riskiahenic receptors in the brain while blocking off, while blocking the off-target effects xanobilin has because of its poor selectivity. This is a perfect validation for the four-receptor target and one of our positive out-of-select modulation products aiming at identifying highly selective and brain-penetrant molecules. In summary, our drug discovery engine has achieved great progress with multiple drug candidates advancing towards IND-enabling studies. The renewed commitment of our partner Indivio, the delivery of a candidate starting IND-enabling studies in the MQ-7 program, and the significant progress achieved in our other preclinical programs are further validation of the quality and productivity of our allosteric modulation platform. This concludes my prepared remarks. And I'll hand it back to Tim.
spk06: Thanks, Robert. I'll now switch to an overview of the financials. Starting with the income statement, we recognize $1.4 million of income in 2022 compared to $3.2 million in 2021. The primary source of revenue is research funding from our collaboration with Indivior, which we expect to reduce in 2023 as drug candidates move to late-stage clinical candidate selection. and our partner takes over more of the operational execution of the development. In terms of expenses, R&D expenses were 14.7 million in 2022 compared to 12.8 million in 2021. The increase of 1.9 million is primarily due to the increased R&D outsourced activities linked to clinical activities that were ongoing in the first half, as well as, to a lesser extent, share-based compensation costs Given that we have terminated clinical activities in 2022, we expect R&D expenditure to be significantly lower in 2023. GNN expenses were $7.3 million in 2022 compared to $5.8 million in 2021. The increase of $1.5 million is due to increased share-based compensation costs. Finance loss of $0.3 million in 2022 relates primarily to exchange gains. due to the strengthening of the US dollar over the period. Now to the balance sheet. Our assets are primarily held in cash and we completed 2022 with 7 million Swiss francs of cash held in Swiss francs. Other current assets of 0.9 million primarily relate to receivables from Indivior and R&D prepayments. Current liabilities of 3.3 million as of December 31, 2022 decreased by 0.9 million compared to the end of last year, 2021, and primarily relate to R&D payables and accruals. Non-current liabilities of 0.1 million as of December 31, 2022 decreased by 1.4 million compared to December 31, 2021, primarily due to decreased retirement benefit obligations calculated under IAS 19. Now to the cash flow statements. We started the year with 20.5 million, raised net proceeds of 3.7 million in the offering executed in July of last year, received 1.1 million research funding from Indivio and consumed 17.6 million in operations. We have a paper profit of 200,000 in Forex when U.S. dollar cash balances are converted to Swiss francs at the end of the year reporting purposes in $7 million of cash at the end of the year. Now, to summarize, the development of 71149 in epilepsy is ongoing and we are looking forward to being able to report very soon the recommendations from the independent interim review committee which has been established by Janssen to review the data from part one. We continue to believe in the value of dipregluant in PD-LID and are evaluating its future development in post-stroke recovery and pain. In parallel, we are pursuing collaborative arrangements in advance development, to advance development, and look forward to sharing more information on this subject in the future. Our preclinical programs continue to make solid progress towards delivering drug candidates for future clinical development. in important therapeutic areas, including stress-related disorders, chronic cough, cognition, and schizophrenia. As a reminder, our portfolio was discovered in-house from our pioneering Allostate modulated drug discovery platform, and consequently, we have a significant intellectual property in all programs. We have a track record of securing partnerships at the preclinical stage and supportive top-tier investors. We recognize the 2022 stock performance and current market capitalization is very disappointing. However, we are having multiple business discussions across our portfolio and strongly believe that if we are successfully in executing our near-term partnering strategy, then our stock price should move to recognize the value of our portfolio. This concludes the presentation and we will now open the call for questions.
spk08: Thank you. Dear participants, as a reminder, to ask a question, you need to press star 11 on your telephone keypad and wait for your name to be announced. To withdraw your question, please press star 11 again. To ask a question via the webcast, please access the Ask a Question tab. Please stand by, we will compile the Q&A results.
spk01: This will take a few moments. Now we're going to take our first question.
spk08: And the question comes from the line of Raghuram Selvaraju from HC Wainwright and Co. Please ask your question.
spk05: Thanks very much for taking my questions. Can you hear me?
spk06: Yes, we can.
spk05: So, firstly, I was wondering if you could frame for us what Janssen might consider an unexpectedly positive outcome from the epilepsy proof of concept study. and in what context they might frame it as such, you know, for example, from a competitive perspective, from the standpoint of being able to combine the molecule with other existing antiepileptic drugs and so forth.
spk06: Okay. So, where do I start? I think we have to remember that when Janssen started this study, they were going to recruit 60 patients, two to one randomized, and that was going to be one cohort. They then modified slightly once they'd started, and now they have publicly announced on clinicaltrials.gov that they are going to have up to three cohorts. Now, because of this, they're not stopping recruitment. Therefore, that's why they've established this independent interim review committee. As Robert mentioned earlier on in the presentation, The end point is, at the end of part one, is how many patients got to the baseline seizure count and how many didn't, and then how that is split between active and placebo. Now, what we know from Janssen is that they're going to report to us a go-no-go decision. So we are not going to, and I don't think Janssen are going to get much granularity from the independent interim review committee, as they really don't want to unblind the study as they move other cohorts. So does that answer your question?
spk05: Sorry, can you hear me? Yes. Yeah, no, no, that's very helpful. And I think, you know, what we wanted to get a better sense of was, you know, if there's likely to be a sort of upside surprise, as it were, from this clinical study result, you know, let's assume that the baseline is for a positive outcome, but what would constitute a positive upside surprise? But I think what you've done is frame it quite nicely. So we appreciate that. The second question is in relation to the M4 allosteric modulator in the context of the zanomaline plus trospium data so far. And I was hoping that you could clarify a little bit, first of all, how you expect the allosteric modulation approach on the M4 target to potentially present advantages versus zanomaline plus trospium. because obviously Zanomaline as a single agent was not successful. That was the reason why they came up with this combination approach. And secondly, whether you think the Zanomaline plus Trospium clinical development programs represent an appropriate template for the future development of your lead candidate, or if your lead candidate is going to follow a somewhat different path, and if so, why? Thank you.
spk03: Yeah, so maybe Robert, you'd like to... Yeah, I'll answer the first question for sure. So, yeah, I mean, it's a very good question. I mean, the main, I would say, and first difference between Corona's approach with xenamine is that this is, I would say, non-selective. It's an M1, M4 agonist. So its mechanism of action is activating the M4 receptor. Coming with a positive our steak modulator. We know that we have all sorts of benefits compared to agonists where we are Helping the activation of the receptor making the receptor more sensitive to its natural ligand acetylcholine and therefore also respecting the natural rhythm of receptor activation so The other difference with Xenobanine of our approach is that we have highly selective
spk07: So that's, I think, in a nutshell, you know, what is differentiating.
spk03: And going forward, you know, if you, again, comparing an agonist approach versus a positive allostatic modulator approach, with an agonist, as long as the agonist is on board, we will be activating the receptor. And we know that this is a receptor that gets desensitized and gets internalized. And so with a positive allostatic modulator, And this can lead to tolerance, and with a positive allostatic modulator, we have demonstrated that, not yet for the M4, but for some of the other positive allostatic modulator programs that we've worked on, that this is not happening. So we don't, basically, we don't see tolerance appearing when we're chronically testing the compound.
spk06: Yeah, regarding the clinical side of things, I think we'll be looking much more closely at Theravel because, I mean, they are developing a positive allosterone modulator on the M4, PAM. So we'll be watching very carefully what they're going to be doing in the clinic.
spk05: Just as a follow-on to that, I thought I would ask a somewhat provocative question. It's well documented that PureTech Health which was one of the original inceptors of the company developing zanomaline plus trospium, has done very well with that investment. And my understanding is there is a historical link between PureTech Health and ADEX. So I was wondering if you could perhaps comment on the degree to which PureTech Health is aware of your activities on the M4 allostellic modulation side, and what their thoughts are as to what has already been demonstrated from a clinical success perspective vis-a-vis anomaline and traspian.
spk06: I mean, all I can say is we're having multiple discussions with multiple parties across our portfolio, and that includes the M4PAM. I mean, as you can imagine, as you know, the corona data has certainly lit up the field. There's a lot of excitement. There's been a number of deals already done on other N4PAM programs. I mean, there was an European acquisition of the Heptaris SOZI program. The Vanderbilt program went to Numora. But there are plenty of other CNS-focused pharma that are watching this space and discussing with us.
spk01: Thank you.
spk06: That's all I can say.
spk01: Thank you.
spk08: Now we're going to take our next question. Please stand by. And the next question comes from the line of Peter Elick from A-Consult. Your line is open. Please ask your question.
spk02: Thank you. I have a very simple question. I noticed in the annual report that the compensation for the board has almost tripled from 21 to 22, and for the executive, it has almost doubled in the same time. Can you explain why?
spk06: Yeah, this is all linked to some reorganization of the share-based compensation program. So it's all non-cash compensation, and it's driven by the IFRS 2 calculations that are
spk01: linked to the reorganization of the equity incentive plan okay thank you thank you now we're going to take our next question just give us a moment and the next question comes from the line of edward riva from
spk08: ZKB, your line is open. Please ask your question.
spk04: Hello, thank you very much for taking my questions. I would have two of them. The first one being, as seen in the slide, that you expect the two E&D enabling studies for the GABA-B, the one that IndieViewer is going to develop and the one you are going to develop in 2024. I was wondering why wouldn't this happen earlier? What are the steps that lead to the start of the E&D enabling studies?
spk06: Yeah, so, I mean, this program has been extremely successful. It's generated a lot of molecules with different profiles. You may be aware that Astellas has a GABA-B positive allosteric modulator, which is in Phase II clinical development for alcohol use disorder. This is the indication of primary interest to Indivior. And therefore, INDIVIOR are profiling many, many, well, several compounds in parallel in multiple preclinical models and doing a very, very thorough job. In fact, a much more thorough job than we expected. And that's why if we look back historically over the guidance, we are certainly delayed And this is for good reason. And they are doing a very thorough job to select compound. Now, the way the selection of compounds works is that Indivior needs to select a compound first before ADDx is able to select. Now, until Indivior selects, ADDx is not able to select. But what we are doing is we are now profiling, I would say, at risk. a number of compounds in some of the indications that we're interested in. We mentioned Charcot-Marie-Tooth, which we have profiled in the past, but we are now looking very closely at chronic cough and certain types of pain as well. And again, these are areas where we are getting some significant interest from potential business partners. And because this is carved out of the collaboration with Indivior, once we've selected compounds, we will actually be free to license them to partners should we get interest or develop them ourselves.
spk04: Understand. Thank you very much. And my second question would be regarding ADX 71449. Are you already recruiting for the second part of the study, or are you waiting for the independent review committee?
spk06: Well, as I said, this is an open recruitment. And as I say, in clinicaltrials.gov, They're going to do up to three cohorts. We are able to say that cohort one has completed. And therefore, you can assume that patients that are being randomized are now being randomized into a second cohort.
spk04: And so those three cohort are only for the second part, not for the first part.
spk06: Well, the study has a part one and a part two. Cohort one was completed with 60 patients with a two-to-one randomization. And those 60 patients have completed part one. And those that didn't hit their baseline seizure count in part one have now rolled over into part two. And the patients who did hit their baseline seizure count have been offered the open label extension study.
spk04: Okay, I think it answers my question. Thank you very much.
spk07: Thank you.
spk08: Thank you. Dear speakers, please be advised at this moment we do not have any more audio questions and we will hand over to the written questions. So now we have the first question from Jesse Brodkin. Can you tell us how many patients from each group advanced from phase one to phase two in the seizure study?
spk06: So when you say phase one to phase two, you're talking about part one to part two, I assume? The answer is we don't have any information on that.
spk01: Thank you.
spk08: We have also another question from Jesse Brodkin. Can you state with confidence that J&J will communicate the data with you and then us from the seizure study?
spk06: Yes, with confidence we will get the data and we will be able to communicate it. I have no information on timing though, so I can't give you any guidance on when that will be.
spk08: Thank you. Now we have another question from Jesse Brodkin. Please give us a time estimate of the communication of the conclusions of the Interim Review Board of the seizure study.
spk06: Yes, so the guidance on the recommendation of the Independent Distributing Committee is early in Q2 of this year.
spk08: Thank you. Now we have another question from Patrick Markey. Which part, if any at all, of the 109M milestone payment from Janssen is coupled to that ADX711 149, epilepsy phase two, study part one related to goal, no goal decision.
spk06: We're not authorized to disclose any granularity around the 109 million masters. I'm afraid we're not authorized to disclose the answer to the question.
spk08: Thank you, dear speakers. Dear participants, as a reminder, if you wish to ask a question over the phone, please press star 11 on your telephone keypad. Alternatively, you can submit questions via the webcast. Dear speakers, there are no further questions at this time, and I would like now to hand the conference over to the management team for any closing remarks.
spk06: Well, thank you very much for attending the conference call and we look forward to speaking to you on the next call. I wish you all a nice day.
spk08: That does conclude our conference for today. Thank you for participating. You may now all disconnect. Have a nice day.
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