Q1 2024 Addex Therapeutics Ltd Earnings Call
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Operator: Good day, and thank you for standing by. Welcome to the Addex Therapeutics full year 2023 financial results and corporate update conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone keypad. You will then hear an automated message advising your hand is raised.
Speaker Change: Good day, and thank you for standing by welcome to the Ebix Therapeutics.
<unk> financial results and corporate update conference call.
Speaker Change: This time, all participants are in listen only mode.
Speaker Change: After the speaker's presentation, there will be the question and answer session.
Speaker Change: To ask a question during the session you will need to press star one one on your telephone keypad you want them.
Operator: To withdraw a question, please press star 1 1 again. Alternatively, you can submit your questions via the webcast. Please be advised that today's conference has been recorded. I would now like to hand the conference over to our speaker today, Tim Dyer.
Speaker Change: I think youre driving your hand is rice.
Speaker Change: So we draw a question please press star one again.
Speaker Change: Turning to me you can submit your questions why the webcast.
Speaker Change: Please be advised that today's conference is being recorded.
Speaker Change: I would now like to hand, the conference over to Speaker today, Tim di Please go ahead.
Timothy Mark Dyer: Hello everyone. I'd like to thank you all for attending our 2023 Financial Results Conference call. I'm here with Mikhail Kalinchev, our Head of Translational Science, who will provide an update on our R&D program. I would draw your attention to the press release and the financial statements issued earlier today, which are available on our website. I also want to draw your attention to our disclaimer.
Tim: Hello, everyone I would like to thank you all for attending all 2023 financial results Conference call I'm here with Mako and then Jeff I'll head of translational science, who will provide an update on our R&D programs.
Speaker Change: Draw your attention to the press release and financial statements issued earlier today, which are available on our website.
Speaker Change: 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.
Timothy Mark Dyer: 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 2023 activities and recent achievements before reviewing our pipeline. I will then hand over to Mikhail, who will review our more detailed summaries of data, clinical, and preclinical programs. I will then speak about the recent launch of Neurosterics before reviewing our 2023 full year financial results. Following that, we will open the call for Q&A. So, let's start with the highlights.
Speaker Change: I will start this conference call by giving a quick overview of the 'twenty to 'twenty three activities and recent achievements before reviewing our pipeline I will then hand over to <unk>, who will review our more detail some of the clinical and preclinical programs.
I will then speak about the recent launch of nearest derek's before reviewing our 2023 full year financial results. Following that we will open the call for Q&A.
Speaker Change: So to start with the highlights.
Timothy Mark Dyer: Our partner Janssen has completed the Phase 2 epilepsy clinical study, and we are now expecting to report data from the study by mid-May this year. I'd like to remind you that an independent interim review committee established by Janssen to review the unblinded data from Part 1 of Cohort 1 made its recommendation to continue the study. This recommendation and the decision by Janssen to continue the study are very encouraging and suggest ADX71149 is safe and well-tolerated and may be having a positive impact on this patient population.
Speaker Change: Our partner Janssen has completed the phase two epilepsy clinical study and we are now expecting to report data from this study by mid May this year.
Speaker Change: I'd like to remind you is an independent interim review committee established by and send them to review the unblinded data from part one of cohort one makes its recommendation to continue the study this recommendation and the decision of Jan.
Speaker Change: To continue the study is very encouraging and suggest a dx 71149 is safe well tolerated and may be having a positive impact on this patient population.
Timothy Mark Dyer: We continue to believe there is value in Diproglorant and have substantially completed our evaluations of future development. For dyskinesia and Parkinson's disease, we have worked with experts on a new trial design, which we believe will overcome the recruitment challenges we encountered in the past. However, our preferred strategy for this indication is to secure a partner prior to restarting development.
Speaker Change: We continue to believe there is value in the garage and have substantially completed our evaluation of the future development.
Speaker Change: Got easier in Parkinson's disease, we have worked with experts on our new trial design, which we believe will overcome the recruitment challenges we encountered in the past.
Speaker Change: Our preferred strategy for this indication is to secure a partner prior to restarting development.
Timothy Mark Dyer: We've also identified post-stroke recovery as an interesting area for future development for Diploglion and are currently profiling Diploglion preclinical models of post-stroke recovery. Furthermore, preclinical data was recently published in the journal Brain, which strongly supports the rationale for inhibition of MDL5 receptor as a treatment for post-stroke recovery. We are pursuing discussions with potential funding sources, including industry partners, for this interesting potential future development path for Dipragloron. In 2023, we announced the extension of our GABA-B, PAM, and Divio collaborations through until June 2024, with 2.7 million Swiss francs of additional research funding.
Speaker Change: We've also identified post strike recovery is an interesting area for future developments typically are all currently profiling different joining pre COVID-19 preclinical models post stroke recovery.
Speaker Change: Furthermore, preclinical data was recently published in the journal brain, which strongly supports the rationale for inhibition of <unk> <unk> five per sector as a treatment for post stroke recovery.
Speaker Change: We are pursuing discussions with potential funding sources, including industry partners for this interesting potential future development path for Bureau.
Speaker Change: In 2023, we announced the extension of our Gaba B, Pam and video collaborations through until June 2024, with $22 7 million Swiss francs of additional research funding.
Timothy Mark Dyer: With this additional R&D funding, we have made excellent progress and advanced multiple drug candidates through the clinical candidate selection phase. As a reminder, Indivio'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. We are focusing our independent program on cost.
Speaker Change: With this additional R&D funding, we have made excellent progress in adult multiple drug candidates through clinical candidate selection phase.
Speaker Change: As a reminder, in DBS primary interest is in substance use disorder.
Under the agreement we have retained the rights to select drug candidates for development in certain exclusive reserved indications.
Speaker Change: We are focusing our independent program on cost.
Timothy Mark Dyer: During 2023, we demonstrated robust efficacy with multiple drug candidates in preclinical models of substance use disorder and cough and are therefore well on track to delivering drug candidates for Indivio and for our own independent cough program. We expect Indivio and ourselves to select compounds to advance into IND-enabling studies in the second half of 2024. We led a consortium that was awarded a €4 million grant from the Eurostars Grant Programme to advance our mGluR2 negative allostatic modulator programme through to delivery of clinical candidates. This is an exciting program for mild neurocognitive disorders that is currently in lead optimisation. Last but by no means least,
Speaker Change: During 2023, we demonstrated robust efficacy with multiple drug candidates in preclinical models of substance use disorder and call and are therefore, well on track to deliver the drug candidates for individuals and for all independent cost program.
Speaker Change: We expect <unk> and ourselves to select compounds to advance into IND, enabling studies in the second half of 2024.
The consortium that was awarded a 4 million Euro grant from the U S dollar Grant program to advance.
Speaker Change: And blew out too negative allosteric modulator program through to delivery of clinical candidates. This is an exciting program for malt neurocognitive disorders that is currently in lead optimization.
Speaker Change: Last but by no means least.
Timothy Mark Dyer: We recently announced the launch of Neurosterics, with a Series A financing round of $63 million led by Perceptive Advisors. This is an innovative financing transaction that provides us with the resources needed to advance our preclinical portfolio without diluting our shareholders' interest in our clinical stage assets and Partner Programmes. Now, for a quick review of our pipeline, as mentioned, we are excited to see the phase two data from our epilepsy program, which is being conducted by Janssen.
Speaker Change: We're very we very recently announced the launch of near Hysterics.
Speaker Change: With a series a financing round of $63 million led by perceptive advisors. This is an innovative financing transaction that provides us with the resources needed to advance our preclinical portfolio without diluting our shareholders' interests in our clinical stage assets.
Speaker Change: Program.
Speaker Change: Speak more about this innovative financing transaction later in the presentation.
Speaker Change: Now for a quick review of our pipeline as mentioned we are excited to see the phase II data from our epilepsy program, which is being executed by Janssen we.
Timothy Mark Dyer: We continue to believe in diploglurons and are executing our plans to recommence development in both dyskinesia-associated Parkinson's disease, as well as preparing Diphagram for a Phase 2 Proof of Concept Study in Post-Stroke Recovery. Our GABA v. PAM collaboration is coming to the end of the discovery phase with candidates on track to start IND-enabling studies later this year. Indivio is executing the Substance Use Disorder Program, and we are preparing candidates for development in COS. Now I will hand over to Misha, who will give you more details about our exciting portfolio.
Speaker Change: We continue to believe in <unk> and are executing our plans to recommence development in both dyskinesia associated Parkinson's disease as well as preparing dip.
Speaker Change: Typically after a phase II proof of concept study in post stroke recovery.
Speaker Change: Our Gaba Pam collaborations coming to the end of the discovery phase with Canada subtract start IND, enabling studies later this year and DVR is executing the substance use disorder program and we are preparing for candidates for development and cost.
Speaker Change: Now I will hand over to Michelle who will give you more details about our exciting portfolio.
Mikhail Kalinichev: Thanks, Tim. Hello, everyone.
Michelle: Thanks, Jim and Hello, everyone.
Mikhail Kalinichev: I will start by speaking about our Phase II Epilepsy Study with Addex 71149, which was recently completed by Young. Epilepsy is a large, multi-billion dollar market opportunity where, despite several available treatment options, many patients are still in need of improved therapies to treat their seizures. As a reminder, ADEX 71149 is a Metabotropic Glutamate Receptor Subtype 2, or mGlu2, positive allosteric modulator discovered in partnership with Janssen using ADEX's proprietary allosteric modulation platform.
Michelle: I will start by speaking about our phase II epilepsy study with at <unk> Seven one was four nine which has been completed recently by young.
Michelle: Epilepsy is a large multibillion dollar market opportunity, where despite several available treatment options. Many patients are still in need of improved therapies.
Michelle: There to treat their seizures as a reminder, <unk> nine is a medical tropic teammates receptor subtype, two or M glued to positive our studying modulator discovered in partnership with Johnson using IDEXX proprietary allosteric modulation platform.
Mikhail Kalinichev: ADDEX 71149 has demonstrated both stand-alone efficacy and a strong synergistic effect in combination with inhibition of SV2A, such as Keppra and Previa. ADEX 71149 has also been thoroughly profiled in preclinical and clinical studies by Janssen, demonstrating its good safety and tolerability profile in healthy volunteers and patients. Janssen, responsible for development, has just completed both the phase two study and an open label extension study in epilepsy patients. Results are expected by mid-May this year. We have significant economics in our deal with young.
Michelle: 71149 has demonstrated both standalone efficacy and a strong synergistic effects in combination with <unk> inhibition of <unk>, such as camera and previous.
Michelle: Alex 71149 has also been thoroughly profiled in preclinical and clinical studies by yachtsman, demonstrating its good safety and Tolerability profile in healthy volunteers and patients.
Michelle: <unk> responsible for development have just completed both the phase two study and an open label extension study in epilepsy patients results are expected by mid May of this year.
Michelle: We have significant economics in our deal with Johnson with Prelaunch milestones of 110 9 million euros low double digit royalties on net sales and Janssen is responsible for all development costs.
Michelle: To illustrate the synergistic effect seen with the combination of added 71149, and Liberty Rotterdam stay active molecule in camera here are the data obtained in the six Hertz cycled the motor seizure module widely recognized as having.
Mikhail Kalinichev: With pre-launch milestones of 109 million euros, low double-digit royalties on net sales, and Janssen is responsible for all development. To illustrate the synergistic effect, same as with the combination of ADEX 71149 and levofotam, the active molecule in capillary— Here are the data obtained in the 6-Hertz psychotomortoseizure model, widely recognized as having high translational value to character As a reminder, ADDEX 71149, given alone in this model, produces robust protection against 6 Hertz-induced seizures with an ED50 of approximately 20 mixes per kick.
Michelle: Hi, transformational value to characterize the efficacy of anti epileptic drugs.
Michelle: As a reminder, other 7119 given the law in this model produces a robust protection against six hurts induced seizures with EDC steel approximately 20 mix per kg.
Michelle: In combination studies with varying doses of Liberty rest of them are fixed dose of <unk> 7149 increase the potency of Liberty.
Michelle: Saddam leading to approximately 35 fold shift in its easy 50 guidance, Conversely, using a fixed dose of Liberty Rotterdam with varying varying doses of IDEXX Telemark nine is increase the potency of the excellent work for nine leading to approximately 14 folks.
Michelle: Shift in its easy 50, suggesting a positive pharmacodynamic relationship.
Mikhail Kalinichev: In combination studies with varying doses of Levetiracetam, a fixed dose of Addex 7149 increased the potency of Levetiracetam, leading to an approximately 35-fold shift in its ED50 values. Conversely, using a fixed dose of Levetiracetam with varying doses of Addex 7149, it increased the potency of Addex 7149, leading to an approximately 14-fold shift in its ED50, suggesting a positive pharmacodynamic relationship or strong synergistic effect for the two molecules when given in combination.
Michelle: Or strong synergistic effect for the two molecules when given in combination.
Michelle: This extraordinary effect of the combination often and glued to pan with an <unk> antagonist has been patented offering a strong protection for this program until 2035 without additional extensions.
Michelle: Okay.
Michelle: This is the phase two study design. The study is a double blind placebo controlled proof of concept study enrolling patients with focal onset seizures, who have suboptimal response to treatment, which nevertheless, it down camera or Pre-war Rotterdam PB Act.
Michelle: In this phase II study design patients.
Mikhail Kalinichev: This extraordinary effect of a combination of an NGLU2PAM with an SV2A antagonist has been patented, offering strong protection for this program until 2035 without additional, This is the Phase 2 study design. The study is a double-blind, placebo-controlled, proof-of-concept study enrolling patients with focal-onset seizures who have a suboptimal response to treatment with levofodiracetam, Keppra, In this Phase II study design, patients established a 28-day seizure count over a 56-day baseline period prior to being randomized to receive either Addex 71149 or matching placebo. The primary endpoint at this time was for patients to return to their monthly baselines.
Michelle: Tablets, and 28 day seizure count over S 56 day baseline period.
Michelle: Prior to being randomized to receive either <unk> 71149 or matching placebo.
Michelle: The primary endpoint in this time taken to return to their amongst the baseline seizure.
Michelle: The study has two parts part one being the four week acute efficacy phase and part two being an eight week maintenance phase of efficacy phase part too.
Michelle: <unk> patients, who did not reach the baseline seizure count during part one of the study and continue on their randomized truck or placebo.
Mikhail Kalinichev: The study has two parts, part one being the four-week acute efficacy phase, and part two being an eight-week maintenance phase of efficacy. Part two includes patients who did not reach their baseline incision count during part one of the study and continue on their randomized drug or placebo. An open-label extension study was ongoing in parallel, offering all patients the opportunity to get treated with Addex 71149 in combination with Plevity Rata-Setam or Privarastam, as previously announced last year.
Michelle: An open label extension study was ongoing and parallel offering all patients the opportunity to get treated with addax. Several one 149 in combination with <unk>.
Michelle: Saddam or pre warehouses.
Michelle: As previously announced last year.
Michelle: An independent interim review committee.
Michelle: Convened by our collaboration partner recommended to continue the study following review of Unblinded data from part one of patient cohort what.
Mikhail Kalinichev: An independent interim review committee convened by our collaboration partner recommended to continue the study following review of unblinded data from Part I of the patient cohort. This was encouraging news, suggesting that ADEX 71149 is safe and well-tolerated and potentially offers benefit to epilepsy. We look forward to sharing the top-line data of cohorts 1 and 2 in mid-May this year.
Michelle: This was encouraging news, suggesting that at seven Walmart four nine is safe and well tolerated and potentially offering benefit to epilepsy patients. We look forward to sharing the top line data of cohorts, one and two in mid May this year.
Michelle: Okay.
Michelle: Following termination of the development of day, probably around in PD lead we embarked on a detailed evaluation of a number of potential indications of interest for future development, including substance abuse disorder migraine and other forms of pain.
Mikhail Kalinichev: Following the termination of the development of DIPRAvirant in PD-LIT, we embarked on a detailed evaluation of a number of potential indications of interest for future development, including substance abuse disorder, migraine, and other forms of pain. We have completed this exercise, and we have identified post-stroke recovery as an interesting indication for the future development of DIPRAvirant. We believe the differentiated profile of Dipraglirone makes it particularly suitable for post-stroke recovery; there is a large unmet medical need for post-stroke recovery and rehabilitation.
Michelle: We have completed this exercise and have identified post stroke recovery is an interesting indication for the future development of <unk>.
Michelle: We believe the differentiated profile of the probably around makes it particularly suitable for post stroke recovery.
Michelle: There is a large unmet medical need in post stroke recovery and rehabilitation.
Michelle: <unk> is among the leading causes of chronic orphan lifelong disability.
Mikhail Kalinichev: Stroke is among the leading causes of chronic, often lifelong, disability, as it leads to motor, sensory, and cognitive impairment and multiple comorbidities. There are over 100 million stroke survivors worldwide, and the number is growing at an annual rate of 12.
Michelle: As it leads to motor sensory cognitive impairment and multiple comorbidities.
Michelle: There are over 100 million stroke survivors worldwide and the number is growing at the annual rate of $12 million.
Michelle: A variety of rehabilitation therapies are used with post stroke patients, but the recovery is slow.
Mikhail Kalinichev: A variety of rehabilitation therapies are used with post-stroke patients, but recovery is slow and often inadequate. There is an urgent need for pharmacological agents that can facilitate recovery stimulated by rehabilitation. Angle 5 receptor is a suitable target to address post-stroke recovery, as it is densely expressed in the brain involving neuroplasticity and modulates excitatory inhibitor equilibrium. In fact, activation of MUR5 has been observed in a range of neurological disorders, including stroke, where it plays a role in the so-called maladaptive rewiring of the brain following stroke.
Michelle: Inadequate.
Michelle: There is an urgent need for pharmacological agents that can facilitate the recovery stimulated by rehabilitation therapy.
Michelle: Emco five receptor is a suitable targets to address post stroke recovery.
Michelle: It is densely expressed in the brain involved the neuroplasticity and modulates excited to inhibitor equilibrium.
Michelle: In fact activation of <unk> five has been observed in the range of neurological disorders, including stroke, where it plays a role in so called maladaptive rewiring of the brain following stroke inhibition of <unk> <unk> five on the other hand can facilitate.
Mikhail Kalinichev: Inhibition of NGL5, on the other hand, can facilitate adaptive rewiring of the brain, promoting neuroplasticity and creating new functional pathways, moving the neural network towards a pre-lesion state. New evidence recently published in the journal Brain suggests that a negative allosteric modulator of MGLU5-MTEP administered daily in rats following stroke results in a sustained and growing improvement in sensory motor function in comparison to vehicles. Similar improvement in sensory-motor function was observed in animals treated with our MGL5-NAM depregnant. MRI imaging of resting state functional connectivity in post-stroke rodents shows that daily administration of MTAP also stimulated intra- and inter-hemispheric connectivity in the brain disrupted by stroke.
Michelle: Adaptive rewiring, the brain promoting neuroplasticity and creating of new functional pathways moving using neural network towards eight pre lesion stake.
Michelle: Exciting new evidence recently published in the journal brain suggests that negative allosteric modulator and.
Michelle: <unk> grew five amtech administered daily rates following stroke results in a sustained and growing improvement in sensory motor function in comparison to vehicle treatment.
Michelle: Similar improvement in sensory motor function was observed in animals treated with our <unk> five now.
Michelle: MRI imaging of the resting state functional connectivity in post stroke rodents shows that daily administration of Amtech also stimulated intra and inter emissary connectivity in the brain disrupted by stroke.
Mikhail Kalinichev: It is important to note that improvement in brain connectivity after stroke is known to correlate with functional recovery and is observed across, Prabirant is ideally suited to be used in tandem with rehabilitation therapies in post-stroke patients as it has a fast onset of action and short half-life. It has shown good tolerability in healthy subjects and in Parkinsonian patients, showing only mild to moderate CNS-related adversity. We have a drug product ready and a strong patent position and believe Dipragmionum can become a first-in-class drug to facilitate post-treatment recovery. We can also speculate that the prevalent mediated adaptive rewiring and facilitation of recovery following brain damage can also be seen in traumatic brain injury.
Michelle: It is important to note that improvement in brain connectivity. After stroke is known to correlate with functional recovery and as observed across species.
Michelle: It probably around is ideally suited to be used in tandem with rehabilitation therapy in post stroke patients as it has a fast onset of action and short half lives.
Michelle: It has shown good tolerability in healthy subjects and in parkinsonian patients showing only mild to moderate CNS related adverse effects.
Michelle: We have a drug product ready and a strong patent position and believe the pregnant women can become a first in class drugs to facilitate post stroke recovery. We can also speculate that the prevalent mediated adaptive rewiring and facilitation of recovery following brain damage can also.
Michelle: B C in traumatic brain injury patients.
Mikhail Kalinichev: Let me now switch to the GABA-B positive allosteric modulator preclinical program, which is partnered with Indivio. The aim of this collaboration is to deliver a new treatment for substance use disorder. DVR is supporting the research at ADDEX and has recently committed an additional 2.7 million Swiss francs funding for us to complete clinical candidate selection activities. In addition to 13.8 million Swiss francs total funding, as a reminder, GABA-B receptor activation has been clinically validated in a number of disease areas using PACWAS, a GABA-B orthosteric agonist.
Michelle: Let me now switch to Gaba positive allosteric modulator preclinical program, which is partnered with <unk>.
Michelle: The aim of this collaboration is to deliver a new treatment for substance use disorders.
Michelle: In DVR is supporting the research at others and have recently.
Committed an additional $2 7 million Swiss francs funding for us to complete clinical candidate selection activities. In addition to $13 8 million Swiss francs total funding so far.
Michelle: As a reminder, Gaba receptor activation has been clinically validated in a number of disease areas using backwater, a Gaba b ortho steric agonist.
Mikhail Kalinichev: Baclofen is FDA-approved for treatment of spasticity and is widely used off-label to treat numerous diseases, including substance use. However, Baclofen has a short half-life and comes with significant side effects, hampering its wider use.
Michelle: Baclofen is FDA approved for treatment of spasticity and is widely use.
Both label to treat numerous diseases, including substance use disorder.
Michelle: However, <unk> has a short half life and comes with significant side effects Humphery, it's why to use that.
Michelle: Thus there is a strong need for a better backlog.
Mikhail Kalinichev: We believe this can be achieved with positive allosteric modulators and their differentiated pharmacology, having the efficacy of baclofen but longer half-lives 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, with the aim to nominate drug candidates ready to enter IND-enabling studies in age 2. As part of our agreement with Indivio, we have the right to select drug candidates from the funded research activities for our own independent GABA-B-PAM program. We have chosen to focus our independent program on COLF, and therefore, I will present this exciting opportunity.
Michelle: We believe this can be achieved with positive allosteric modulators and their differentiated pharmacology, having the efficacy of baclofen.
Longer half life and improved side effect profile.
Michelle: We are well on our way to meeting this objective with multiple novel drug candidates rapidly advancing through clinical candidate selection phase.
Michelle: Aimed to nominate drug candidates ready to enter IND, enabling studies in age to 22 four.
Michelle: As part of our agreement with <unk>, we have the right to select drug candidates.
Michelle: They funded research activities for our own independent Gaba Pam.
Michelle: Pam.
Michelle: We have selected to focus our independent program on pulp and therefore, our present this exciting opportunity.
Mikhail Kalinichev: There is a strong rationale for developing GABA-B-PAMS for chronic cough. Chronic cough is a persistent cough that lasts for more than 8 weeks and can be caused by a variety of factors including respiratory infections, asthma, allergies, and acid reflux, but also possibly by an overactive stomach acid reflux. There is a large unmet medical need for novel antitrusive drugs, as current standards of care are ineffective in 30% of patients and only moderately effective in up to 60%.
Michelle: There is a strong rationale for developing <unk> for chronic cough.
Michelle: Chronic cough is a persistent cough that lasts for more than eight weeks and can be caused by a variety of factors, including respiratory infection asthma allergies and acids reflux, but also possibly by an overactive cough reflex.
Michelle: There is a large unmet medical need in novel anti <unk> drugs as current standards of care are ineffective in 30% of patients and only moderately effective in up to 60% of patients.
Mikhail Kalinichev: In addition, the current treatments carry risks of serious side effects. On the next slide, we show that GABAvipams are likely to have a superior tolerability profile in comparison to the current standards of care and show no taste-related side effects, as seen with a newly approved P2X3 inhibitor, Kefalonib. Support for using GABA-B agonists in the treatment of chronic cough comes from the clinical evidence that Baclofen, a GABA-B agonist, is used off-label in cough patients and from anatomical evidence that GABA-B receptors are strongly expressed in airways and in the neuronal pathway regulating cough. Therefore, we believe that GABA-V PAMS could offer superior efficacy in cough patients.
Michelle: In addition, the current treatments carrier risks of serious side effects.
Michelle: On the next slide we show that Cabo pounds are likely to have a superior tolerability profile in comparison to the current standards of care and show no taste related side effects as seen with our newly approved <unk> inhibitor.
Michelle: Support for using double at times in treatment of chronic cough comps from the clinical evidence that umpqua fed a Gaba b agonist is used off label in cough patients and from anatomical evidence of Gaba receptors are strongly.
Michelle: Preston Airways and in the Eurozone, possibly irregularity costs.
Michelle: Therefore, we believe that the Gaba Pam could offer superior efficacy in cough patients.
Michelle: Yeah.
Mikhail Kalinichev: Therefore, we believe that government hands could be an innovative new treatment for chronic cough administered once daily via oral dosing and offering improved efficacy and tolerability with fewer non-responder patients suitable for chronic dosing, therefore significantly improving patients' quality of life. We are working with multiple compounds progressing in the late clinical candidate selection phase, and we expect to move into IND-enabling studies in H2 2024 in parallel to delivering compounds for our partner individuals Now I hand it over back to Tim.
Michelle: Therefore, we believe that coupled with hubs.
Michelle: Could be an innovative new treatment of chronic cough administered once daily by oral dosing and offering improved efficacy and tolerability with fewer non responder patients suitable.
Michelle: For chronic dosing, therefore significantly improving patients quality of life.
Michelle: We are working with multiple compounds progressing in late clinical candidate selection phase and we expect to move into IND, enabling studies in age to 2024 in parallel to delivering compounds for our partner in television.
Michelle: Now I hand, it over back to Tim.
Timothy Mark Dyer: Thanks Misha. Now, before I move on to the financials, I would like to spend a few moments speaking about the Neurosterix transaction. Due to the excellent progress made by our R&D team in advancing our unpartnered preclinical portfolio, our M4-PAM, MgluR7-NAM, and MgluR2-NAM programs have reached a stage of development where they now need significant amounts of financing to progress into the clinic. However, unfortunately, given the low market capitalization of ADDEX, raising the amount of capital needed would have been extremely challenging and highly diluted for our shareholders
Tim: Thanks Michelle.
Tim: Before I move on to the financials I would like to spend a few moments to speak about the nearest eric's transaction.
Tim: Due to the excellent progress made by our R&D team in advancing our unparalleled preclinical portfolio RM for Pam <unk>, seven now and I'm glad to know programs reached a stage of development, where they now need significant amounts of financing to progress into the clinic.
Tim: Certainly given the low market capitalization of robotics.
Tim: Raising the amount of capital needed would have been extremely challenging and highly dilutive for our shareholders. So we decided to spin out these programs and our platform into a new private company and raise the necessary capital into the new private entity. We believe this is an excellent transaction products shareholders as it has secured.
Timothy Mark Dyer: So we decided to spin out these programs and our platform into a new private company and raise the necessary capital for the new private entity. We believe this is an excellent transaction for Addex shareholders as it has secured $5 million for Addex and removed the financing overhang on Addex shares. We have retained a 20% interest in Neurosteric so we can benefit from the upside from advancing the programs into the clinic, which is now secured by the 63 million capital from a high-quality investor syndicate led by perceptive advisors. As part of the transaction, we have divested our Anisotropic Modulation technology platform, including the majority of our staff, and significantly reduced our cash burn going forward. However, we have entered into a service agreement with Neurosterics to ensure that we can access the skills needed to execute on our business strategy.
Tim: $5 million for IDEXX and removed the financing overhang on the attic stop.
Tim: We have retained a 20% interest in euro Derrick So we can benefit from the upside from advancing the programs into the clinic, which is now secured by the $63 million capital from our high quality investors Syndicate led by perceptive advisors.
Tim: As part of the transaction, we have divested our allosteric modulation technology platform, including the majority of our staff and significantly reduced.
Tim: Cash burn going forward.
Tim: However, we have entered into a service agreement with nearest Derrick to ensure that we can access the skills needed to execute on our business strategy.
Timothy Mark Dyer: Now for a review of our 2023 financial results. Starting with the income statement, we recognize 1.6 million in revenue in 2023 compared to 1.4 million in 2022. The primary source of revenue is research funding from our collaboration with Vendivia, which is recognized as the associated research costs are incurred.
Tim: Now for a review of our 2023 financial results.
Tim: Starting with the income statement, we recognized $1 6 million of income in 2023 compared to $1 4 million in 2022 primary source of revenues research funding from our collaboration with <unk>, which is recognized as he is.
Tim: Associated research costs are incurred.
Timothy Mark Dyer: In terms of expenses, R&D expenses were $7 million in 2023 compared to $14.7 million in 2022. The decrease of $7.7 million is primarily due to the termination of Diploclarant development for dyskinesia with Parkinson's disease and the disbanding of our U.S. clinical team in 2022. G&A expenses were £5 million in 2023 compared to £7.3 million in 2022. The decrease of £2.3 million is primarily due to reduced share-based service costs and decreased D&O insurance costs.
Tim: In terms of expenses R&D expenses were $7 million in 2023 compared to $14 7 million in 2022, a decrease of $7 7 million, primarily due to the termination of <unk> development.
Tim: In Dyskinesia says you were Parkinson's disease under the spending all of our U S clinical team in 2022.
Tim: G&A expenses were $5 million in 2023 compared to $7 3 million in 2022. The decrease of $2 3 million is primarily due to reduced share base service costs and decreased D&O insurance costs finance results.
Timothy Mark Dyer: The finance results... are primarily related to foreign exchange losses on cash held in U.S. dollars, partially offset by interest income on U.S. cash deposits, which we hold to hedge against near-term U.S. dollar denominated costs. Now to the balance sheet. Our assets are primarily held in cash, and we completed 2023 with 3.9 million Swiss francs of cash held in Swiss francs and US dollars. Other current assets amount to $0.4 million and primarily relate to R&D prepayments and trade receivables that mainly relate to our agreement with Indivior.
Tim: This primarily relates to foreign exchange losses on cash held in U S dollars, partially offset by interest income on U S cash deposits, which we hope to hedge against near term U S dollar denominated costs.
Tim: Now to the balance sheet, our assets are primarily held in cash.
Tim: Three to 2023 with $3 9 million Swiss francs of cash held in Swiss francs in U S dollars.
Tim: Other current assets amounted to <unk> 4 million, primarily relate to R&D prepayments and trade receivables mainly related to our agreement with <unk> current liabilities of $2 9 million.
Timothy Mark Dyer: Current liabilities of $2.9 million, as at the end of December 2023, decreased by 0.4 million compared to the same time in 2022 and primarily relate to R&D payables and receivables. Non-current liabilities of 0.6 million increased by 0.5 million Swiss franc compared to December 31, 2022 and the primary rate of retirement benefit obligation. Now to the cash flow statement. Starting the year with $7 million, we raised net proceeds of $4.5 million in an equity offering executed in April 2023.
Tim: As at the end of December 2023 decreased $5 4 million compared to the same.
Tim: Time in 2022.
Tim: Primarily related to R&D payables and accruals.
Non current liabilities of $6 million increased.
<unk> zero 5 million Swiss franc compared to December 31, 2000, and trying to jam primary rate retirement benefit obligations.
Tim: Now to the cash flow statements, we started the year with $7 million we.
Tim: We raised net proceeds of $4 $5 million in an equity offering executed in April.
Tim: 2023, we received $1 2 million from the sale of Treasury shares.
Tim: <unk> $1 9 million research funding from a deal we spent $9 9 million on our operations.
Timothy Mark Dyer: We received 1.2 million from the sale of treasury shares, and received 1.9 million in research funding from Indivio, and spent $9.9 million on our operations. We have an unrealized gain of 0.4 million on Forex, and U.S. dollar cash balances are converted to Swiss francs, resulting in 3.9 million of cash at the end of the year. Now to summarize. I hope you have understood how transformative the Neurosterics deal is for addicts. We've strengthened the balance sheet and secured the financing to execute on the development of our preclinical portfolio, including advancing the very exciting M4 PAN program for schizophrenia into the clinic.
Tim: We have an unrealized gain of 4 million on Forex.
Tim: In U S. Dollar cash balances are converted to Swiss francs, resulting in $3 $9 million of cash at the end of the year.
Speaker Change: Now to summarize.
Speaker Change: I hope you have understood how transformative the nearest stacks daily <unk>, we strengthened the balance sheet and secured the financing to execute on the development of our preclinical portfolio, including advancing the very exciting and full pan program for schizophrenia into the clinic our.
Speaker Change: Yeah. So the partnership is poised to deliver phase II data in epilepsy by mid May of this year, which will be an important value inflection point for the program.
Speaker Change: And the company and our partnership with <unk> is on track to deliver clinical candidates ready for ion DNA studies by the end of June of this year <unk> is ready to restart clinical development on the subject of a number of partnering discussions are independent Gaba Pam cough program is on track to start IND, enabling studies.
Timothy Mark Dyer: Our Janssen partnership is poised to deliver Phase 2 data in epilepsy by mid-May this year, which will be an important value inflection point for the program and the company, and our partnership with Indivio is on track to deliver clinical candidates ready for IND-enabling studies by the end of June of this year. Diproglirant is ready to restart clinical development and the subject of a number of partnering discussions. Our independent GABA-B-PAM-COF program is on track to start IND-enabling studies also.
Speaker Change: Also.
Speaker Change: We are validating partnerships with industry supported ambassadors and a strong balance sheet, which puts us on a solid position to deliver on our strategic objectives.
Speaker Change: This concludes the presentation and we will now open the call for questions.
Speaker Change: Thank you Yeah participants as a reminder, if you wish to ask a question over the phone. Please press star one on the telephone keypad and Lake financial announced.
Timothy Mark Dyer: We are validating partnerships with industry, supportive investors, and strong balance sheets, which puts us in a solid position to deliver on our strategic objectives. This concludes the presentation, and we will now open the call for questions. Thank you.
Speaker Change: Can we draw a question. Please press star one again.
Speaker Change: Turning something you'll get your questions via the webcast.
Speaker Change: Chris and Bob will compile the Q&A narrow studies will take a few moments.
Operator: Thank you. Dear participants, as a reminder, if you wish to ask a question over the phone, please press star 1-1 on your telephone keypad and wait for your name to be announced. To withdraw a question, please press star 1-1 again. Alternatively, you can submit your questions via the webcast. Please stand by while we compile the Q&A roll studies. It'll take a few moments. And now we're going to take our first question, and it comes from the line of Joanne Lee from Maxim Group. Your line is open; please ask your question.
Speaker Change: And now we're going to take the first question and it comes from the line of John Lee from Maxim Group. Your line is open please ask a question.
John Lee: Hi, This is Julian speaking thanks for taking the question Anna Firstly, congratulations on the New York Eric feel.
John Lee: So now that you know you secured some funding through the ideal what are the upcoming auctions, specifically, which program are you prioritizing for advanced snack.
John Lee: Yes, so we continue to execute on the <unk> collaboration.
John Lee: So our primarily primary focus is to deliver the clinical candidates.
John Lee: So that <unk> can make their selection by the end of June.
John Lee: Because under the deal we have the right to then select second choice. They have choice, we have a false choice.
Joanne Lee: Hi, this is Joanne speaking. Thanks for taking the question and, firstly, congratulations on the Neurosterics deal. So now that you know you secured some funding through that deal, what are the upcoming actions, specifically which program are you prioritizing for advanced?
John Lee: Sorry, that's really our priority because once entyvio are able to select it means we can also select and that will then give us the candidate that we can advance.
John Lee: Into the IND, enabling studies for the cost program.
Speaker Change: Gotcha so.
Speaker Change: I'm getting that the priority is would be the and the Gaba program and Goodyear. So I'm aware that you guys you Havent really seen some positive preclinical data and are currently in the candidate selection phase I wanted to ask what specific criteria are you considering when evaluating potential candidates connect program and.
Timothy Mark Dyer: Yeah, so we continue to execute on the endeavial collaboration. So our primary focus is to deliver the clinical candidate so that Indiviel can make their selection by the end of June because, under the deal, we have the right to then select second choice. They have a third choice; we have a fourth choice. So that's really our priority, because once Indivio is able to select, it means we can also select. And that will then give us a candidate that we can advance into the IND-enabling studies for the COF program.
Speaker Change: The cross selling regarding the collaboration with them to the areas currently thought too.
Speaker Change: Until the end of June are you considering a independently moving the asset into the clinic or are there sort of discussions underway to extend that collaborations further okay.
Yes.
Speaker Change: In addition to the Gaba B.
Program. We also have typically around we've done a lot of work to EM.
Speaker Change: Two design.
Speaker Change: A new study in PD lid and we've also.
Joanne Lee: Gotcha, so I understand that the priority would be the GABA program and the Indivier. I'm aware that you guys have been releasing some positive preclinical data and are currently in the candidate selection phase. I wanted to ask what specific criteria you are considering when evaluating potential candidates for this program? And as a follow-up, additionally, regarding the collaboration with Indivier, it's currently set to continue until the end of June. Are you considering independently moving the asset into the clinic, or are there still discussions underway to extend that collaboration further? Thank you.
Speaker Change: We are currently completing preclinical.
Speaker Change: Preclinical work in the stroke recovery area.
Speaker Change: Now Alex is continue to dialogue with potential partners.
Speaker Change: And we continue to have discussions not only around it for clearone and PD lid, but typically want in post stroke recovery and but also and we have started to identify some potential partners.
Speaker Change: For the gathered the cough program. However, you can imagine we are not going to we're not free to disclose as much information about the Gaba.
Timothy Mark Dyer: Yeah, so, you know, in addition to the GABA-B program, we also have Dipragloron.
Speaker Change: Candidates.
Speaker Change: Until.
Speaker Change: <unk> has exercised their selection.
Timothy Mark Dyer: We've done a lot of work to design a new study in PD-LID. We've also, and we are currently completing preclinical work in the stroke recovery area. Now, you know, ADDEX has continued to dialogue with potential partners, and we continue to have discussions not only around diprogluerant in PD-Lid but also diprogluerant in post-stroke recovery, but we have started to identify some potential partners for the GABA-B COF program. However, you can imagine we are not going to, and we are not free to disclose much information about the GABA-B candidates until Indivior has exercised their selection because, at the moment, while we have a good idea of which candidates they will select and which we will select, until they have formally selected, they have first choice, so they could select any of the candidates.
Speaker Change: Because at the moment, while we have a good idea of which can does it they will select and which candidates we will select until they have formally selected.
Speaker Change: They have first choice. So they can select any of the candidates, which means we are not at liberty.
Speaker Change: And to disclose any information.
Speaker Change: About the candidates.
Speaker Change: And to your question about how we are.
Speaker Change: Characterizing.
Speaker Change: The target product profile would look like all the different candidates.
Speaker Change: That's a that's a confidential information and we're not at Liberty to disclose it.
Speaker Change: I'm sorry about that.
Speaker Change: Got it that's very helpful. I'm really exciting stuff I had and thanks again for taking the questions.
Speaker Change: Youre welcome. Thanks.
Speaker Change: Thank you.
Timothy Mark Dyer: Which means we are not at liberty to disclose any information about the candidate, and to your question about how we are characterizing and what the target product profile would look like for the different candidates, you know that's confidential information, and we're not at liberty to disclose it. I'm sorry about that.
Speaker Change: Now we're going to take our next question.
Speaker Change: Just give us a moment.
And the next question comes from the line of <unk> Krum Silverado from H C. Wainwright <unk> co. Your line is open please ask a question.
Krum Silverado: Thanks, very much for taking my questions and congratulations on all the progress the Neurostar X transaction in particular.
Krum Silverado: Just wanted to ask first of all with respect to the <unk> program can you give us a sense Tim.
Joanne Lee: Got it. Well, that's very helpful. Really exciting stuff ahead, and thanks again for taking the question. You're welcome.
Krum Silverado: Some of the recent precedent transactions or comparator is might be in this space and what implications that could have for Neurostar X as well as add extra stake in Neurostar X going forward.
Operator: Now we're going to take our next question. Just give us a moment. And the next question comes on the line from Raghuram Selvaraju from HC Wainwright & Co. Your line is open; please ask your question.
Krum Silverado: Especially if you continue to have development success with work regarding that specific target.
Raghuram Selvaraju: Thanks very much for taking my questions and congratulations on all the progress, the Neurosterics transaction in particular. Just wanted to ask, first of all, with respect to the M4 program, can you give us a sense, Tim, of what some of the recent precedent transactions or comparables might be in this space and what implications that could have for Neurosterics as well as Addex's stake in Neurosterics going forward, especially if you continue to have development success with work regarding that specific target?
Tim: Yeah, Hello Ram. Thank you very much for the question and yes at the back end of last year, Cerro del and which is leading the field in muscarinic M for positive allosteric modulators with M. <unk>.
Speaker Change: They are in phase III.
Speaker Change: They were purchased for a.
Ram: But a little south of $9 billion by Abbvie.
Ram: Yeah.
Ram: So that's a very nice comparison, where we believe our program is about two and a half years behind this.
Ram: And clearly.
Ram: That M&A activity.
Ram: I would say sharpen the interests of perceptive and the Investor syndicates.
Timothy Mark Dyer: Hello, Ram. Thank you very much for the question. At the back end of last year, CeraVel, which is leading the field in muscarinic M4 positive allosteric modulators with mRaclidin, they're in phase two. They were purchased for a little south of $9 billion by AbbVie. So that's a very nice comparator.
Ram: Let's put the $63 million behind to nearest Eric's.
Ram: And then coming pretty quickly after the <unk> M&A.
Ram: BMS purchase.
Ram: Sure.
Ram: Corona.
Ram: Which has filed for registration with a.
Ram: With a product called car X T. Now car X T is in four and one preferring agonist.
Timothy Mark Dyer: We believe our program is about two and a half years behind theirs, and clearly, that M&A activity, I would say, sharpened the interest of Perceptive and the investor syndicate, has put $63 million behind Neurosteric, and then, pretty quickly after the Cerevel M&A, BMS purchased Karuna, which has filed for registration with a product called Car XT. Now Car XT is an M4, M1 So again, much of the efficacy that's been seen in the phase three program of CAR-XT is coming from its M4 agonist activity, which is a very strong validation, again, of the M4-PAM approach in schizophrenia.
Ram: And.
Ram: So again much of the efficacy that's been seen in the phase III program with <unk> T is coming from the <unk> in schizophrenia, I should say is coming from it and for.
Ram: Agonist activity, which is a very strong validation again off the.
Ram: <unk> for Pam approach in schizophrenia.
Ram: Now.
Ram: And again, we're some way off from from filing for registration however.
Ram: We have $60 million on the balance sheet of nearest Eric's, we are owning 20% of it.
Ram: So you can imagine we have got the capital to advance the <unk> program.
Ram: And through Phase one development.
Ram: And also can you just clarify two other points the first is <unk>.
Timothy Mark Dyer: And again, we're some way off from filing for registration. However, you know, we have 60 million on the balance sheet of Neurosterix, and we own 20 percent of it. And so you can imagine we have got the capital to advance the M4 PAM program and through phase one development.
Ram: With respect to the other programs that <unk> plans to advance maybe give us a flavor of what the target indications might be beyond schizophrenia, or adjunct to therapy in schizophrenia, which probably would be the most appropriate application of the <unk> pathway modulator as well as if there are likely to be.
Raghuram Selvaraju: Thanks. And also, can you just clarify two other points? The first is, with respect to the other programs that Neurosterix plans to advance, maybe give us a flavor of what the target indications might be beyond schizophrenia or adjunctive therapy in schizophrenia, which probably would be the most appropriate application of the M4 pathway modulator, as well as if there are likely to be any future targets that Addex could conceivably retain the right to pursue using the original Addex technology platform, or if these are all going to ultimately be Thank you.
Ram: Any future targets.
Ram: IDEXX could conceivably retained the right to pursue using the original IDEXX technology platform or if these are all going to ultimately be taken forward by neurostar.
Ram: Yeah.
Speaker Change: Yeah, the technology platform.
Speaker Change: And all the preclinical programs.
Speaker Change: Programs, except for the Gaba Pam are all now in nearest derricks.
Speaker Change: And therefore IDEXX interest in these is through our equity interest.
Speaker Change: Which we plan to protect going forward.
Speaker Change: So the other targets, which are being financed or the <unk> seven and.
Timothy Mark Dyer: The technology platform and all the preclinical programs except for the GABA BPAM are all now in Neurosteric, and therefore Addex's interest in them is through our equity interest, which we plan to protect going forward. So the other targets which are being financed are the mGluR7, and this is the negative allostate modulator program for stress-related disorders, and there are a number of very interesting indications in neuropsychiatry, but we're not at liberty to disclose those, and then there's the mGluR2 negative modulator program, which has gone across to Neurosterics along with the Eurostar grant that was secured last year. So this has happened.
Speaker Change: This is the negative allosteric modulator program to stress related disorders.
Speaker Change: And there are a number of very interesting.
Speaker Change: Indications in neuropsychiatry, but we're not at Liberty to disclose those.
Speaker Change: And then as the glue ought to negative modulator program.
Speaker Change: Which has gone across 10 years derek's along with the U S. Dollar grant that was secured last year.
Speaker Change: So this has.
Speaker Change: In addition to the of course some of the 60 million that sitting in Europe Derek's. It also has.
Speaker Change: The Eurostar consortium, Grumped, which is driving that program rapidly forward with the consortium.
Timothy Mark Dyer: In addition to, of course, some of the 60 million that's sitting in Eurosterix, it also has the Eurostar Consortium Grant, which is driving that program rapidly forward with the consortium to clinical candidate selection, but currently is in lead optimization. And again, this program is for cognition, and cognition is an unmet medical need across a number of neurodegenerative disorders. And again, we're not at liberty to disclose the details of some of those indications that we'll be going after.
Speaker Change: To the clinical candidate selection, but currently is in lead optimization and again this program is cognition.
Speaker Change: In cognition is.
Medical need across.
Speaker Change: A number of neuro degeneration trends to neuro degenerative disorders.
And again, we're not at Liberty to disclose the details of some of those indications that we'll be getting after.
Timothy Mark Dyer: And there is another program on an undisclosed neurological target. And we certainly have the plans within Neurosterics to definitely leverage the platform. But again, I'm not at liberty to disclose details of those activities at the current time.
Speaker Change: And there is and there is another program on an undisclosed neurological targets.
Speaker Change: <unk>.
Speaker Change: And we certainly have plans within nearest derek's too.
Speaker Change: To definitely leverage the platform, but again.
Speaker Change: Not at Liberty to disclose details of those activities are Tom Tom.
Raghuram Selvaraju: Thank you very much. And just one quick housekeeping item, if I may, can you tell us whether the equity stake that Addex has in Neurosterix is in any way preferred, and or if Addex might in the future have the ability or the option, or at least, you know, would not be restricted in any way from investing in Neurosterix and future funding rounds in order to maintain the 20% equity stake? Addex has...
Speaker Change: Thank you very much and just one quick housekeeping item if I may.
Speaker Change: Can you tell us whether it'd be equity stake that IDEXX has in Neurostar X is in any way preferred and or if IDEXX might in the future have the ability or the option or at least would not be restricted in any way from investing in neurostar and future funding rounds in order to make.
The 20% equity holder.
Speaker Change: No.
Timothy Mark Dyer: Addex has the same rights as the investors, and Addex has the right to... participate pro rata in all future financing, and you know our intention is to protect our 20% interest in Neurosterics going forward, but as you can imagine, we're 60 million on its balance sheet. We don't expect to have to participate in a future fundraising for quite some time.
Speaker Change: <unk> has.
Speaker Change: The same rights as the investors.
Speaker Change: Analytics has.
Speaker Change: Right too.
Speaker Change: Participate pro rata in all future financing.
Speaker Change: And our intention is to protect our 20% interest in neurostar rates going forward.
But as you can imagine.
Speaker Change: So as you can imagine with 60 million on its balance sheet, we don't expect to have to participate in our future fundraising for quite some time.
Operator: 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 your questions via the webcast. And now we're going to take our next question. And the question comes from the line of Michael Akunovic from Maxim Group. Your line is open. Please ask a question.
Speaker Change: Great. Thank you.
Speaker Change: Thank you.
Speaker Change: Yeah participants as a reminder, if you wish to ask a question over the phone. Please press star one one on your telephone keypad antenna company you can submit your questions via the webcast.
Speaker Change: And now we're going to take over next question.
Speaker Change: And the question comes from the line of Michael <unk> from Maxim Group. Your line is open. Please ask your question.
Michael Akunovic: Hey there. Good morning or good afternoon, everyone. Thank you for taking my questions and congratulations on all the progress this past quarter. I guess I'd like to ask just about the epilepsy program. Given that that data is approaching, could you remind us of the criteria that the IRC was using to determine whether or not to proceed with that?
Speaker Change: Okay.
Michael: Hey, there good morning, or good afternoon, everyone. Thank you for taking my questions and congrats on all the progress this past.
Michael: Quarter.
Michael: So.
Michael: I guess I'd like to ask just on the epilepsy program given that that data is approaching could you remind us of the criteria that the IRC, we're using to determine whether or not to proceed with that.
Timothy Mark Dyer: Yeah, so we haven't actually disclosed the criteria. However, there were some criteria. [inaudible] So what we know today is that the Independent Review Committee must have seen at least a signal in cohort one, for part one, the four-week acute efficacy period in Cohort 1. So that was 60 patients after four weeks.
Speaker Change: Yes, so and we haven't actually disclosed the criteria.
Speaker Change: However, there were some criteria.
Speaker Change: So what we know today is that the independent review Committee.
Speaker Change: And must have seen at least a signal in cohort one.
Speaker Change: Part one so the first.
Speaker Change: Full week acute efficacy period in cohort one so that was 60 patients.
Timothy Mark Dyer: We know that they must have seen at least the signal. Otherwise, they would not have recommended continuing. They also would not have seen any safety and tolerability issues. Those are the two things we know because we're not. In fact, we don't actually know what the criteria were, but we know that those are the details that we know and that's what we're allowed to disclose.
Speaker Change: After four weeks.
Speaker Change: Know that they must have seen at least the signal otherwise.
Speaker Change: They would not have recommended to continue they all say.
Speaker Change: Wouldn't would not have seen any safety and tolerability issues.
Speaker Change: So those are the two things we know because we're not.
Speaker Change: In fact, we don't actually know what the criteria were.
Speaker Change: But we know that that that's the details that we know and that's what we're allowed to disclose.
Michael Akunovic: I'm sorry. Thank you for that. I would like to see, are you at liberty to discuss any more granularity on the pre-launched milestone structure for that program, in particular, if any are attached to that Phase 2 data?
Speaker Change: Okay. Thank you for that.
Speaker Change: I would like are you at Liberty to discuss any of the.
Speaker Change: Any more granularity on our prelaunch milestones structure for that program in particular, if any are attached to that phase II data.
Timothy Mark Dyer: Right, so... If you look through the previous disclosure, Addex received a milestone when J&J dosed the first patient in phase one. We also received a milestone when J&J dosed the first patient in phase two. We are also at liberty to disclose that the €109 million in milestones are all development and regulatory. So there are no sales milestones included in that mail, so I think you can sort of work out and... And if you look at the amounts of the Phase I and Phase II milestones, you can probably work out when the next milestone is coming, and you can probably work out that it's pretty back-ended. So, thank you. You know, we're not relying on any cash inflows from this partnership to finance Addex for some time.
Speaker Change: Right so.
Speaker Change: If you look through the previous disclosure.
Speaker Change: You know Alex received a milestone when J&J dosed the first patient in phase. One we also received a milestone when J&J dosed the first patient in phase two.
Speaker Change: We are also at Liberty to disclose that the 109 million euros of milestones are all development and regulatory.
Speaker Change: So theres no sales milestones in Q2 that Mt.
Speaker Change: So I think you can you can sort of work out.
Speaker Change:
Speaker Change: And if you look at the amounts of the phase one phase two milestones you could probably work out when the next milestone is coming and you can probably work out but its pretty back ended.
Speaker Change: So.
Speaker Change:
Speaker Change: We're not relying on any cash inflows from this partnership to finance statics for some time.
Michael Akunovic: All right. Thank you. And that actually just leads into my last question, just more of a modeling and financial question. I just wanted to see if you could help me understand what assumptions are going into your runway projection and then how much of the previous burn rate was dedicated to staff and programs that are now being handled at Neurostaris.
Speaker Change: Yeah.
Speaker Change: Alright, Thank you and that actually leads into my last question just more of a.
Speaker Change: I guess modeling and financial angled question I just wanted to see if you could help me understand what assumptions are going into your your runway projection and then how much of the previous burn weight burn rate was dedicated to staff and programs that are now being handled at narrows Derrick.
Timothy Mark Dyer: Yeah, so we have significantly removed the operating burn of Addex. Now, what is not included in our guidance for into 2026 is the cash required to fund the clinical development of Diprogloron, for example, and we have not included the costs required to develop the cost program. What we have included there is the cost of operating Addex, and so operating, being a public company, operating an IR business development, finance activity, and some pre-clinical work on Diplogluron for the stroke indication, and some clinical activities to prepare the development plans for Dipraglorant for stroke and for dyskinesia in Parkinson's, and plus some money to finish off preparation and the CMC for the GAVA-B cost program.
Speaker Change: Yeah, So we have significantly removed.
Speaker Change: The operating burn of IDEXX.
Speaker Change: So.
Speaker Change: Now what is not included in <unk>.
Speaker Change: Guidance of into 2026.
Speaker Change: Is the cash required.
Speaker Change: To fund.
Speaker Change: Clinical development of <unk> for example.
Speaker Change: And we have not included the costs required to develop the cost program.
Speaker Change: What we have included there is a is the cost of operating addax.
Speaker Change: Sorry, operating being a public company.
Speaker Change: Operating in IR business development finance activity.
Speaker Change: And in some.
Speaker Change: Preclinical work.
Speaker Change: On that particular one.
Speaker Change: For the stroke indication.
Speaker Change: And some clinical activities to prepare the development plans.
Speaker Change: Four.
Speaker Change: Typically launch in stroke and in the dyskinesia in Parkinson's.
Speaker Change: And plus some money to finish off.
Speaker Change: The preparation and the CMC for.
Speaker Change: The casualty cost programs.
Michael Akunovic: All right. Thank you very much for taking my questions today. And once again, congratulations on the fantastic progress.
Speaker Change: Alright, Thank you very much for taking my questions today and once again congrats on the fantastic progress.
Speaker Change: Thank you.
Speaker Change: Thank you.
Operator: And now we will proceed to any written questions. Just give us a moment. We have a few questions on the webcast. The first question comes from Michael Hofer, and his question is, how high is the first milestone payment to be expected?
Speaker Change: Okay.
Speaker Change: And now we will proceed to any questions just give us genomics.
Speaker Change: Well have a few questions on the webcast. The first question comes from the line of Michael Hoffman and his question is how high the first milestone payment is to be expected.
Timothy Mark Dyer: I'm sorry but, you know, we're not at liberty to disclose that information. As I pointed out in the response to one of the previous questions, there was a publicly disclosed Phase 1 milestone and a public discourse phase 2 start milestone, but we're not at liberty to guide you on the next milestone, I'm afraid.
Speaker Change: Okay.
Speaker Change: Oh, I'm sorry, but.
Speaker Change: Not at Liberty to disclose that information.
Speaker Change: You know as I pointed out in the response to one of the previous questions.
Speaker Change: There was a publicly disclosed phase one milestone.
Speaker Change: In our public discourse phase two start milestone.
Speaker Change: But we're not at Liberty to guide on the next milestone I'm afraid.
Operator: Thank you. We have another question from Michael Hofer. What will be the forecasted expenses in 2024 to date drop significantly, and from which month?
Speaker Change: Yeah.
Speaker Change: Thank you we have another question from Michael Hoffman, what would be the forecast.
Speaker Change: <unk> expenses in 2020 for two they dropped significantly.
Timothy Mark Dyer: Yeah, so we're not disclosing the details of the forecast. However, I mean, if you look at the expenses of 2023, they will be significantly reduced, and because all the facilities, all the... The majority of the staff have moved to Neurosterics, and that is effective on the 1st of March.
Michael Hoffman: From which month.
Speaker Change: Yes, so we're not <unk>.
Speaker Change: Closing the details of the forecast.
Speaker Change: However, I mean, if you look at the expenses.
Speaker Change: 2023 and will be significantly reduced.
Speaker Change: Because all the facilities all the <unk>.
Speaker Change: The majority of the staff.
Speaker Change: Moved to nearest Eric's.
Speaker Change: And that is effective the first of March.
Operator: Thank you. We have another question from Michael Hofer.
Speaker Change: Thank you we have another question from Michael Hoffman.
Michael Hofer: Why can no number be named for these milestone payments? There are, for sure, contracts, and the amounts are written down. How much is the next milestone payment to be expected? I expect here a clear number.
Michael Hoffman: I know number can be named of these milestones payments that Ralph Shaw contracts and the amount of return down how much is the next milestone payments to be expected.
Michael Hoffman: I expect a clean number.
Timothy Mark Dyer: Well, you'll need to talk to J&J because J&J have not authorised us to give any granularity around the economics of the contract with them. We have a contract. We have confidentiality clauses in the contract, and we respect the confidentiality that we've signed up to and I hope Mr. Hoffa can respect that position. Thank you. And now I would like just to give a quick overview.
Michael Hoffman: Well, you'll need to talk to J&J, because J&J have not authorized us to give any grand granularity around the economics of the contract with them.
Speaker Change: A contract.
Speaker Change: We have confidentiality clauses in the contract and we respect the confidentiality that we signed up to and I hope Mr. Halter can respect that position.
Speaker Change: Thank you and now I would like just to give a quick reminder, took the participants if you would like to ask the last question. Please press star one one on the telephone keypad attended to really you can submit questions while the webcast.
Operator: Thank you. And now I would just like to give a quick reminder to the participants, if you would like to ask the last questions, please press star 11 on your telephone keypad. Alternatively, you can submit questions via the webcast. There are no further questions. I would now like to hand the conference over to Tim Dyer for any closing remarks.
Speaker Change: There are no further questions I would now like to hand, the conference over to Tim <unk> for any closing remarks.
Timothy Mark Dyer: Well, thank you, everyone, for attending our 2023 conference call. And thank you very much for your questions. And we look forward to speaking to you again soon. Have a very nice day.
Speaker Change: Yes.
Tim: Well. Thank you everyone for attending our 2023 conference call.
Tim: Thank you very much for your questions and we look forward to speaking to you again soon.
Tim: A very nice day.
Operator: Let us conclude our conference for today. Thank you for participating. You may now all disconnect. Have a nice day.
Tim: That does conclude a teleconference for today. Thank you for participating you may now disconnect have a nice day.
Tim: Okay.
Tim: [music].
Tim: Uh huh.
Tim: [music].
Tim: Yes.
Tim: [music].
Tim: Yeah.
Tim: [music].
Tim: Okay.
Tim: [music].