Half Year 2024 Addex Therapeutics Ltd Earnings Call & Business Update
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[inaudible] Dyer, Timothy
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Operator: Good day, and thank you for standing by.
Operator: Welcome to the Addex Therapeutics' half-year 2024 financial results and corporate update conference call. At this time, our participants are in listen-only mode.
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Speaker Change: Good day and thank you for standing by. Welcome to the addicts' subpoetics half year 2024 financial results and corporate update conference call. At the start of participants are in listen only mode. After this because presentation, there will be a question and answer session. To ask a question during the session, you need to press star 1-1 on your telephone keypad. You wouldn't hear an attempt at message advising your hand is raised.
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Operator: Dear participants, due to the technical issues today, please use the download button to download the presentation from the download menu and follow it. Thank you so much.
Operator: And now I would like to hand over the conference to your speaker today. Team, please go ahead.
Timothy Dyer: Hello everyone, I would like to thank you all for standing by and attending our half-year 2024 financial results conference call. I'm here with Misha Kalinichev, head of translational science, who will be providing an update on our R&D programs. I draw your attention to the press release and the financial statements issued earlier today, which are available on our website. Unfortunately, there has been a technical issue with loading the presentation to the webcast system, so please use the download button in order to download the presentation. We will be indicating slide numbers so that you will be able to follow, hopefully.
Team Dyer: And now I would like to hand over the conference to your speaker today, Team Dyer, please go ahead.
Team Dyer: Hello everyone, I'd like to thank you all for standing by and attending our half year 234 batch results conference call.
Team Dyer: I'm here with Misha Kalinichev, I'm Head of Translational Finance who will be providing update on our R&D programs. I draw your attention to the press release and the financial statements issued earlier today, which are available on our website.
Speaker Change: I'm fortunate there has been a technical issue with loading the presentation to the webcast system so please use the download button in order to download the presentation. We will be indicating slide numbers so that you will be able to follow hopefully.
Timothy Dyer: So, on to slide three, the disclaimer slide. I also draw your attention to our disclaimers. We will be making certain forward-looking statements that are based on the knowledge we have today.
Speaker Change: So on to slide 3 to the disclaimer slide, I also draw your attention to our disclaimers. We will be making certain forward-looking statements.
Speaker Change: that are based on the knowledge we have today.
Timothy Dyer: I will start this conference call by giving a quick overview of our recent activities and achievements before reviewing the pipeline.
Speaker Change: I will start this conference call by giving a quick overview of our recent activities and achievements before reviewing about our pipeline.
Timothy Dyer: I will then hand over to Misha, who will review in more detail some of our clinical and pre-clinical programs. I will then speak about the recent launch of Neurosterics before reviewing our half-year 2024 financial results; following that, we will open the call for Q&A. So moving to slide four highlights. We launch Neurosterics for the Series A of 63 million led by Perceptive Advisers. This is an innovative financing transaction that provides us with the resources needed to adopt our pre-clinical portfolio without diluting our shareholders' interest in our clinical stage ethics and partner programs. As part of the transaction, we receive 5 million Swiss francs and a 20% equity interest in Neurosterics, securing the balance sheet and retaining significant upside in the programs for our shareholders.
Misha: I will then hand over to Misha who will review in more detail some of our clinical and preclinical programs. I will then speak about the recent launch from your esterics before reviewing a half year 2020 for financial results. For him that we will open the call for Q&A.
Speaker Change: So moving to slide four highlights. We launch new aesthetics for the series A of 63 million load by percent of advisors. This is an innovative finance and transaction Spiders with the resources needed to adapt our preaching portfolio without diluting our shareholder's interest in our clinical stage ethics and partner's programs.
Speaker Change: As part of the transaction, we receive 5 million Swiss francs and the 20% equity interest in the restarics.
Speaker Change: Securing the balance sheet and retaining significant upside in the programmes for our shareholders. I will speak more about this innovative finance and transaction later in the presentation.
Timothy Dyer: I will speak more about this innovative financing transaction later in the presentation. We have made excellent progress in our GABAV-PAM program, and our partner, Indigior, has selected a compound for development in substance use disorders. And will now take over operational responsibility for development. As a reminder, under the terms of the agreement, Addix is eligible for payments of up to $330 million on successful achievement, a pre-specified regulatory, clinical, and commercial milestones, as well as tiered royalties on the level of next sales from high single digit up to low double digits. Under the terms of the agreement, we have exercised our right to select an independent compound to advance our own GABAV-PAM program for the treatment of chronic cost.
Speaker Change: We have made excellent progress in our GABA V-Pound Program and our partner indeed, or a selected compound for development in substance use disorders and will now take over operational responsibility for development.
Speaker Change: As a reminder, under the terms of the agreement, Alex's eligible for payments of up to $330 million on successful achievement, a pre-specified regulatory clinical and commercial market as well as tiered royalties on the level of next sales from high-single digits up to low.
Speaker Change: Davon Dyerz.
Speaker Change: Under the terms of the agreement, we have exercised our right to select an independent compound to advance our own Gabbaby Pan program for the treatment of chronic cough. We have some exciting data in cough with our lead compound which Misha will be sharing with you later in our presentation.
Timothy Dyer: We have some exciting data in the cough with our lead compound, which Misha will be sharing with you later in our presentation.
Timothy Dyer: Jansson Pharmaceuticals, this continued development of ADXM1149. In epilepsy, our partnership remains ongoing while the full data is set from the Phase II study as an adjunctive epilepsy treatment is analysed. Now moving on to, as mentioned, our partner and Divya has selected a GABA B-PAM drug candidate to develop in substance use disorders and expects to start IND enabling studies in the first half of 2025. We are advancing an independent GABA B-PAM program for chronic cough and expect to start IND-enabling studies in 2025, subject to securing financing. We continue to believe in our executing our plans to re-position the development for brain injury recovery.
Speaker Change: Jansson Pharmaceuticals discontinued development of ADX-71149. In epilepsy, our partnership remains ongoing while the full data set from the Phase 2 study as an agiantive epileptic treatment is analyzed.
Misha: Now moving on to slide five, the pipeline side.
Speaker Change: Now for a quick review of our pipeline.
Speaker Change: As mentioned, our partner, in DIVI, or has selected a Gabber B-Pam drug-canders to develop and substance use disorders and expects to start IND enabling studies in the first half of 2025.
Speaker Change: We are advancing an independent gather of the Pan-Programs of chronic cough and expects our IND enabling studies in 2025 subject to securing financing.
Speaker Change: We continue to believe in deep progress, our executing our plans to reposition the development for brain injury recovery.
Timothy Dyer: Euresterex has made excellent progress in advancing its pipeline, including starting IND-enabling studies with its M4 PAM program.
Yuris Sterex: Yuris Sterex has made excellent progress in advancing its pipeline, including starting IND and A-Bing studies with its M4 Pam program.
Timothy Dyer: Now I will hand over to Misha, who will give you some more details about our exciting thoughts earlier.
Yuris Sterex: Now I will hand over to Misha who will give you some more details about our exciting portfolio.
Mikhail Kalinichev: Thanks, Tim.
Mikhail Kalinichev: Hello everyone. I will start by speaking about the Progeny grant in our plans for development in brain injury recovery. Following the termination of the development of the program grant in PIDELID, we embarked on the detailed evaluation of a number of potential indications of interest for future development. We have completed this exercise and have identified brain injury recovery as an interesting indication for the future development. We believe the differentiated profile of the program grant makes it particularly suitable for enhancing the impact of rehabilitation in traumatic brain injury and stroke patients. Please move to slide 7. There is a large unmet medical need in post-stroke recovery and rehabilitation.
Misha: Thanks to Hello everyone, I will start by speaking about the project of London our plans for development in brain injury recovery.
Speaker Change: For the determination of the development of the program in PIDLIT, we embarked on the details evaluation of a number of potential in the case of interest for future development.
Speaker Change: We have completed this exercise and have identified brain injury recovery as an interesting indication for the future development.
Speaker Change: We believe the differentiated profile of the program that makes it particularly suitable for enhancing the impact of rehabilitation in traumatic brain injury and stroke patients.
Speaker Change: Please move to Flight 7.
Speaker Change: There is a large, unmet medical need in post-stroke recovery and rehabilitation.
Mikhail Kalinichev: Stroke is among the leading causes of chronic, often lifelong disability, as it leads to motor, sensory, cognitive impairment, and multiple comorbidities. There are over 100 million stroke survivors worldwide, and the number is growing at the annual rate of 12 million. A variety of rehabilitation therapies are used with post-stroke patients, but the recovery is slow and often inadequate. There is an urgent need for pharmacological agents that can facilitate the recovery stimulated by rehabilitation therapies. Slide 8. Angle-5 receptor is a suitable target to address post stroke recovery as it is densely expressed in the brain, involved in neuropusticity and modulates excisively inhibitorial equilibrium.
Speaker Change: Stroke is among leading causes of chronic, often life-long disability.
Speaker Change: As it leads to modern sensory cognitive impairment and multiple comorbidities.
Speaker Change: There are over 100 million stroke survivors worldwide.
Speaker Change: and the number is growing at the annual rate of 12 billion.
Speaker Change: And variety of rehabilitation therapies are used with post-stroke patients.
Speaker Change: But the recovery is slow and often inadequate.
Speaker Change: There is an urgent need for pharmacological agents that can facilitate the recovery stimulated by rehabilitation therapy.
Speaker Change: Flight 8.
Speaker Change: And the five receptor is a suitable target to address post-stroke recovery as it is densely expressed in the brain, involving neuroposticity and modulating excitation and cilitary equilibrium.
Mikhail Kalinichev: In fact, activation of amglo-5 has been observed in a range of neurological disorders, including stroke, where it plays a role in maladaptive rewiring of the brain. Fallen. Inhibition of MWR-5, on the other hand, can facilitate adaptive requiring of the brain, promoting neuroplasticity and creating of new functional pathways, moving the neural network towards pre-lesion states. Slide 9: Exciting new evidence recently published in the journal Brain suggests that the negative ulceric modulator of MWR-5 MPEP, administered daily, arrest following stroke results in a sustained and growing improvement in sensory motor function in comparison to vehicle treatment. Similar improvement in sensory motor function was observed in animals treated with our MWR-5 depraglot.
Speaker Change: In fact, activation of a glorified has been observed in a range of neurological disorders, including stroke, where place the role in maladaptive rewiring of the brain, following stroke.
Speaker Change: Inhibition of NGR5, on the other hand, can facilitate adaptive rewinding of the brain, promoting neuro-pusticity and creating of new functional pathways, moving the neural network towards pre-leasions state.
Speaker Change: Flight 9.
Speaker Change: Exciting New Evidence, recently published.
Speaker Change: in the journal brain.
Speaker Change: Suggest that the negative aspect, motivator of MWR5, and tap.
Speaker Change: Administered Daily is right following stroke, results in a sustained and growing improvement in sensory mode of function in comparison to vehicle treatment.
Speaker Change: Similarly, improvement in sensory motor function was observed in animals treated with our glorified name depragament.
Mikhail Kalinichev: Please move to slide 10. MRI imaging of the resting state functional connectivity in post-stroke rodents shows that daily administration of MPEP also stimulates intra- and inter-hemispheric connectivity, the brain disrupted by stroke. It is important to note that improvement in brain connectivity after stroke is known to correlate with functional recovery and is observed across species. Slide 11: The prevalent 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 health subjects and in Parkinsonian patients, showing only mild to moderate CNS-related adverse effects.
Speaker Change: Please move to flight 10.
Speaker Change: MRI imaging of the resting state functional connectivity in post-stroke rodents, shows that daily administration of M-TAP also stimulates
Speaker Change: Intra and Intra have a very connectivity, is a brain disrupted by stroke. It is important to note that implements in brain connectivity, often stroke, is known to correlate with functional recovery and is observed across species.
Speaker Change: 5.11.
Speaker Change: The problem 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.
Speaker Change: It has shown good tolerability in health and subject, and in Parkinsonian patients showing only mild to moderate CNS related adverse effects.
Mikhail Kalinichev: We have a drug product ready and a strong patent position and believe the prevalent can become a first-in-class drug to facilitate post-stroke recovery. We can also speculate that the prevalent mediated adaptive rewiring and facilitation of recovery following brain damage would also be seen in traumatic brain injury patients.
Speaker Change: [inaudible]
Speaker Change: We have a drug product ready and a strong patent position and believe the problem can become a first-inclath drug to facilitate post-stroke recovery. We can also speculate that the problem of mediated adaptive rewiring and facilitation of recovery following brain damage would also be seen in traumatic brain injury
Mikhail Kalinichev: Please move to slide 12. Let me now switch to our GABA-B positive-allosteric-modulative program, which is partnered with NIVIA. The aim of this collaboration is to deliver a better vaccine for substance use disorders. Slide 13: As a reminder, GABA-B receptor activation has been clinically validated in a number of disease areas, including Baclofen, a GABA-B autosteric agonist. Baclofen is FDA approved for treatment of spasticity and is widely used off-label to treat numerous diseases, including substance use disorders. However, baclofen has a short half-life and comes with significant side effects, hampering its wider use. Thus, there is a strong need for better baclofen.
Speaker Change: Let me now switch to our Gabbabi positive ulceric-monulated program which is partnered with Divir. The aim of this collaboration is to deliver a better back-off end for substance use disorders.
Speaker Change: Flight 13.
Speaker Change: As a reminder, Kalabi receptor activation has been clinically validated in a number of disease areas, including...
Speaker Change: Um...
Speaker Change: Baclusen, Agababhi Autostatic Agatis. Baclusen is FDA approved for treatment of spasticity and is widely used off-label to treat numerous diseases, including substance use disorders.
Speaker Change: However, Bakulsen has a short half-life and comes with significant side effects, hovering its wider use.
Mikhail Kalinichev: We believe this can be achieved with positive-allosteric modulators and their differentiated pharmacology, having the efficacy of Baclofen but longer half-life and improved side effects process. Our partner, Indivior, has selected a Gababi Pam drug candidate for development in substance use disorders and expects to start ID enabling studies in H1 2025. Please move to slide 14. As part of our agreement with Indivior, Addex has exercised its right to select a compound to advance its own independent Gababi Pam program for the treatment of chronic cough. I will now present this exciting opportunity. Slide 15. There is a strong rationale for developing Gababi Pam for chronic cough.
Speaker Change: Thus, there is a strong need for better marketplaces. We believe this can be achieved with positive ulcerate modulators and their differentiated pharmacology, having the efficacy of marketplaces, but longer half-life and improved side effect profile.
Speaker Change: Our partner in DVOR has selected a government pam drug candidate for development in substance use disorders and expects to start ID enabling studies in age 12, 2025.
Speaker Change: Please move to flight 14.
Speaker Change: Jissel.
Speaker Change: As part of our agreements with the New York, Alex has exercised its rights to select a compound to advance its own independent governing program for the treatment of chronic cough.
Speaker Change: I will now present this exciting opportunity.
Speaker Change: [inaudible]
Speaker Change: There is a strong rationale for developing guava-bipams for chronic cough.
Mikhail Kalinichev: A chronic cough is a persistent cough that lasts for more than eight weeks and can be caused by a variety of factors, including respiratory infections, asthma, allergies, and acid reflux, but also possibly by overactive cough reflux. There is a large unmet medical need in noble antitusive drugs, as current standards of care are ineffective in 30% of patients or only moderate rate of active in up to 60% of patients. The current treatment's care risks are serious side effects. Slide 16. On the next slide, we show that Gababi Pam 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 newly approved P2X3 inhibitor, give up itself.
Speaker Change: Kornikov is a persistent cause that lasts for more than eight weeks and can be caused by the variety of factors including resturgery infections, asthma, allergies and acid reflux, but also possibly by an overactive conflict like this.
Speaker Change: There is a large, unmet medical need in novel antitudes of drugs as current standards of care are ineffective in 30% of patients or only moderate radioactive in up to 60% of
Speaker Change: In addition, the current treatment care risks of serious side effects.
Speaker Change: Sly 16
Speaker Change: On the next slide, we show that Kabagpams are likely to have a superior tolerability profile in comparison to the current standards of care and show no taste-related side effects.
Speaker Change: As seen was newly approved P2X3 inhibitor Gefarping Song.
Mikhail Kalinichev: Please move to slide 17. Support for using Gababi Pam in treatment of chronic cough comes from the clinical evidence that Bakluthan, a Gababi agonist, is used off label in cough patients. And from anatomical evidence, Gababi receptors are strongly expressed in airways and in the neuronal pathway regulating cough. Therefore, we believe that Gababi Pam could offer superior efficacy in cough patients. Slide 11. The pre-IND activities, including individual proof-of-concept, non-GLP talks, and CMC, have been completed, and our clinical candidate has shown favorable efficacy, tolerability, and developmental profiles. Our clinical candidate has demonstrated a consistent minimum-effective dose of one-mix per kick and ED50 of six-mix per kick in cold frequency.
Speaker Change: Please move to flying 17.
Speaker Change: Support for using WPPM, infringement of chronic cough, comes from the clinical evidence that Baclusen, a guava biagnist, is used off-label in cough patients.
Speaker Change: and from Anatolika Lavagins and Gumpopyrusceptors are strongly expressed in airways and in the neuronal pathway regulating cough.
Speaker Change: Therefore, we believe that government hands could offer superior efficacy.
Speaker Change: Incostation.
Speaker Change: Why do you have it?
Speaker Change: We, we are in the activities, including in the group of concepts, non-Jokey talks, and CMC have been completed, and our clinical candidate has shown favorable efficacy, tolerability and development ability profile.
Speaker Change: Our clinical candidate has demonstrated a consistent minimum effective dose of one mixed per kick, and edfifty of six mixed critiques in call frequency.
Timothy Dyer: Noise signs of tolerance were seen after subcronic dosing, and a tensile safety margin was demonstrated based on tolerability by markers. The IND-enabling studies are planned to start in 2025. Slide 19. The next set of slides describes the IND-enable proof-of-concept studies in models of cough. In a model of citric acid-induced cough in DNFIX, acutely administered compound A delivered a robust antitussive activity profile, reducing the cough number and increasing the weight in situ the first cough. The antitusive profile of cough in the same model was more modest, as cough latency remained largely unchanged. In the same experiment, Compound A was better tolerated than Bacchosen, as there were no mark changes in respiratory rate, body temperature, and plasma concentration of growth hormone at up to 16 mixed fatigue.
Speaker Change: No signs of tolerance were seen after subcroning doses and a tenfold safety margin was demonstrated based on tolerability biomarkers.
Speaker Change: The IND enabling studies are planned to start in 2025.
Speaker Change: Flight 19.
Speaker Change: The next set of slides describe the illegal proof of concept studies in models of course.
Speaker Change: In a model of citric acid induced coughing, genealogics, acutely administered compound A delivered erobus, antideusive activity, profile, reducing the cough number and increasing the late into the first cough.
Speaker Change: The antitucid profile of Pakistan, the same model was more modest as conflators to remain largely unchanged.
Speaker Change: Flight 20.
Speaker Change: In the same experiment, Kompound A was bent to tolerate the buckleset, as there were no mark changes in respiratory rate, but a temperature and plasma concentration of growth hormone at up to 16 mixed proteins.
Timothy Dyer: In contrast, Bacchosen suppressed respiratory rate, reduced body temperature by near 2 degrees Celsius, and increased growth hormone concentration in plasma, starting at 3 mixed fatigue dose. Thus, we believe we achieved our goal to discover a better Bacchosen for chronic cough. Please move to slide 21. In a model of citric acid and use cough in deep peaks, sub-chronically administered Compound A showed signs of improved efficacy and potency and no signs of tolerance in comparison to an acute treatment. Slide 22: As expected, signs related to safety and tolerability of Compound A remained largely unchanged on the subchronic versus acute treatment region.
Speaker Change: In contrast, Aquacen's suppressed respiratory rates, reduced body temperature by year to 2 degrees Celsius and increased growth hormone concentration in plasma starting at 3 mixed protein dose.
Speaker Change: Thus, we believe we achieved our goal to discover a better vaccine for chronic cough.
Speaker Change: Please move to fly 21.
Speaker Change: In a model of citric acid and just cough in ghee pigs, some chronically administered compound A, showed signs of improved efficacy and potency and no signs of tolerance in comparison to an acute treatment.
Speaker Change: Flight 22.
Speaker Change: As expected, signs related to safety and tolerability of compound A remained largely unchanged on the sub-chronic versus acute treatment region.
Timothy Dyer: Slide 23: In the model of ATP-potentiated citric acid cough in deep peaks, in a head-to-head comparison experiment, acutely administered Compound A and the P2X3 inhibitor had similar efficacy and tolerability for files. Please move to slide 24. In summary, we have selected a clinical candidate for chronic cough with a robust, reproducible antitusive efficacy of one nitro kick and a good PKPD. The Compound showed a favorable development profile in non-GLP talk studies performed red dogs and non-hewn primates. We are on track to start IND enabling studies early age one 2025.
Speaker Change: 523.
Speaker Change: In the model of ATP potentiated citric acid cough in GDPics, in a head to head comparison of experiment, a hugely administered compound A and a P2X3 inhibitor had similar efficacy and tolerability for foxes.
Speaker Change: So, let's move to slide 24.
Speaker Change: In summary, we have selected a clinical case candidate for chronic cough with a robust reproducible for antitucyle efficacy of one of the case and a good PKPD.
Speaker Change: The compound showed a favorable, developed ability profile in non-GLP talks studies performed red, dogs, and non-human primates.
Speaker Change: We are on track to start ID enabling studies early age 12, 25.
Timothy Dyer: This concludes our prepared remarks on the progress of our R&D Progress.
Speaker Change: This concludes our prayer remarks on the progress of our R&D progress.
Timothy Dyer: Now I hand it back to you.
Timothy Dyer: Thanks, Misha.
Speaker Change: Now I headed back to date.
Timothy Dyer: Slide 25: Before I move on to the financials, I would like to spend a few moments to speak about the Neuosterics transaction. Slide 26 Due to the excellent progress made by our R&D team in advancing our own partner's pre-clinical portfolio, our M4PAM, MBLO7NAM, and MBLO2NAM programs reached a stage of development where they needed significant amounts of financing to progress into the clinic. Unfortunately, given the low market capitalization of ADEX, raising the amounts of capital needed would have been extremely challenging and highly diluted to our shareholders. So we decided to spin out these programs and our platform into a new private company and raise the necessary capital directly into a new private company.
Speaker Change: Thank you, Mikhail.
Speaker Change: So, it's July 25th.
Speaker Change: Now, before I move on to the financials, I would like to spend a few moments speaking about the newest OX transaction.
Speaker Change: Slide 26.
Speaker Change: Due to the excellent progress made by R&D team in advancing our own partners, pre-tankled portfolio, our own four-pound member in Blossom and Nam, and in Blossom, Nam programs reach to stages of development where they needed significant amounts of financing to grasp into the clinic.
Speaker Change: Fortunately, given the landmark capitalisation of addicts, raising the amounts of capital needed would have been extremely challenging and highly diluted through our shareholders.
Speaker Change: So we decided to spin out these programs and our platform into a new private company and raise the necessary capital directly into a new private company.
Timothy Dyer: We believe this is an excellent transaction for ADEX shareholders as it has secured 5 million ADEX and removed the financing overhang on the ADEX stock. We have retained a 20% interest in Neuosterics so we can benefit from the upside from advancing the programs into the clinic, which is now secured by 63 million of capital from a high-quality investment syndicate led by the sector advisers. As part of the transaction, we have divested our IALA State Modulated Technology platform, including the majority of our staff. 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.
Speaker Change: We believe this is an excellent transaction for addict shareholders, as it has secured 5 million radics and we move the financing overhang on the addict stock.
Speaker Change: We have retained 20% interest in your esterics so we can benefit from the upside from advancing the progress into the clinic which is now secured by 63 million capital from a high-quality investor syndicate led by deceptive advisors.
Speaker Change: As part of the transaction, we have divested our Alistair modulator technology platform included in the majority of our staff. However, we have entered into a service agreement within your esterics to ensure that we can access the skills needed to execute on our business strategy.
Timothy Dyer: Now moving on to slide 27 financials. Now for review of our half year and Q2 2024 financials. Following the Neurosterics transaction, we were required under IFRS to identify continuing operations related to our retained business and discontinued operations related to the divested business, Sauce Neurosterics. All income and expense items related to the discontinuing operations have been re-classed under a specific line of the comprehensive loss called net profit or loss from discontinued operations. Slide 28, starting with the income statement which related to continuing operations, we recognize 0.1 million of income in Q2 2024 compared to 0.6 million in Q2 2023.
Speaker Change: Now moving on to slide 27 financials.
Speaker Change: Now, for a view of our half year and Q2204 financials, following the nearest dose transaction, we are.
Speaker Change: We're required under IFRS, so identify continuing operations related to our retained business and discontinued operations related to the diverse business-solce-neurostetics.
Speaker Change: All incoming expense items related to the discontinuing operations have been reclassed under a specific line of the comprehensive loss called net profit of loss, sorry net profit all loss from discontinued operations.
Speaker Change: Slide 28, starting with the income statement, which related to continuing operations. We continue, we recognise.
Speaker Change: 0.1 million have been come in Q2 2024 compared to 0.6 million in Q2 2023. The primary source of revenue is research funding from our collaboration with Indivio, which is recognised that the associated research costs are incurred.
Timothy Dyer: The primary source of revenue is research funding from our collaboration with which is recognized as the associate of research costs are incurred. Continuing R&D expenses primarily relate to our GABA BPM program and remains stable at 0.3 million in Q2 compared to Q2 2023. Continuing operations in GNA expenses, primary rate, corporate development activities are remains stable at 0.7 million in Q2 2024 compared to Q2 2023. The finance result in Q2 2024 is primarily related to foreign exchange losses and, to a lesser extent, interest income on USD cash deposits.
Speaker Change: Continuing R&D expenses primarily relate to our GABAB Pam program and remains stable at 0.3 million in Q2 compared to Q2 2023.
Speaker Change: Continuing operations in GNA expenses, primary rate, corporate development activities and remains stable at 0.7 million in Q2, 2020, full compared to Q2, 2020, 3.
Speaker Change: The Finance Result in Q2 2020 for its primary related to foreign exchange losses and to a lesser extent to interest income on the US DE cash deposits.
Timothy Dyer: Slide 29 now to the balance sheet. Our assets are primarily held in cash, and we completed Q2 2024 with 3.8 million Swiss francs of cash held in Swiss francs and US dollars. Other current assets amounted to 0.9 million, primarily relate to prepaid retirement benefit annually paid at the beginning of each year due to the new Sterics transaction. We expect 0.6 million to be re-invirTed in the short term. Current liabilities are 0.9 million as of June 30, 2024, decreased by 1.9 million compared to June 30, 2023, primarily relate to the cruels and payables related to clinical research organizations and other outsourced service providers.
Speaker Change: Sly 29, now to the balance sheet.
Speaker Change: Or assets are primarily held in cash.
Speaker Change: and we completed QT2224 with 3.8 million Swiss francs of cash held in Swiss francs and US dollars.
Speaker Change: Other current assets amounted to 0.9 million are merely relate to prepaid retirement benefit.
Speaker Change: and you'll be paid at the beginning of each year due to the new strict transaction, we expect 0.6 million to be reimbursed in the short term.
Speaker Change: Current Liabilities are 0.9 million as of 2030s, 2020-2024 decreased by 1.9 million compared to 2030-2023. And primarily relate.
Speaker Change: to accruals and payables related to clinical research, organizations and other outsourcervs providers.
Timothy Dyer: Non-current liabilities are 0.1 million decreased by 0.5 million compared to December 31, 2023, primarily due to start transferred to nearest sterics.
Speaker Change: Non-current liabilities are 0.1 million decreased by 0.5 million compared to December 31, 2023, primarily due to stops transferred to nearest sterile.
Timothy Dyer: Now on to slide 20, 30; sorry, by 30. Submarine. I hope you have understood how transformative the New Historic deal is for Addex. With strength in the balance sheet and secure the financing to execute on the development of our preaching and portfolio, including the very exciting M4 Positive Alistair Modulator Program for Schizophrenia. We've made excellent progress in our GABA B-PAN program with our partner interview or selecting a compound for development in substance use disorders, with IND and studying expected to start in the first half of next year. Difficluent is ready to restart clinical development for brain injury recovery, and our independent GABA B-PAN COF program is demonstrated excellent pre-clinical efficacy and tolerability, with IND and opening studies ready to start.
Speaker Change: [inaudible]
Speaker Change: Now on to slides.
Speaker Change: 20, 30, sorry, by 30.
Samaraj: Samaraj, Samaraj.
Speaker Change: I hope you have an understood how transformative the New York State's deal is, Radik.
Speaker Change: We're strengthening the balance sheet and secure the financing to execute on the development of our pre-tunic report, fully including the very exciting and for positive analysis, modularized program to schizophrenia.
Speaker Change: We've made excellent progress in our Gabbard B. Power and Program with our partner in DIV or selecting a compound to development in substitute disorders with our Indian Aving study expected to start in the first half of next year.
Speaker Change: Dipper Glond is ready to restart clinical development for brain injury recovery, and our independent KABB PAM cough program has demonstrated action of preclinical efficacy and tolerability with ING in 18 studies ready to start.
Timothy Dyer: We have validating parts through the industry supporting investors and a strong balance sheet which puts us on a solid position to deliver on our strategic objectives.
Speaker Change: We are validating parts through the industry supporting investors and strong buyers, which puts us on a solid position to deliver on our strategic objectives. This concludes presentation and we will now open the call for questions.
Operator: This concludes the presentation, and we will now open the call for questions.
Speaker Change: Thank you, dear participants as you remind me if you would ask a question please press star 1 1 on your telephone keypad and wait for a name to be announced. To do a question please press star 1 1 again. Attendance, believe you can send me your questions while the webcast. Please, the Bible will compile the Q&A, or studies will take a few moments.
Speaker Change: [inaudible]
Raghuram Selvaraju: Now we will take the first question, and it comes to the line of Raku Ram Sardaraju from H.C. Wainwright and Co. Yolani's open piece after questions.
Speaker Change: i
Speaker Change: And now we're going to take a first question and it comes to an end of Rakhu Ramsevaraju from H.C. Wayne Wright and Cole. Yolanda Zopin Pisa's two questions.
Raghuram Selvaraju: Thanks so much for taking my questions, and congratulations on all the progress on so many fronts. Firstly, I wanted to ask if you have some sense of the specific clinical indications in which you expect the chronic cough program to proceed with highest probability. Clearly, chronic cough is a serious symptomatic hallmark of many different respiratory, pulmonary, and inflammatory diseases, but I wanted to know which ones you consider to be particularly attractive and what we might expect to be the clinical path forward. For example, would you be considering advancement in COPD or sarcoidosis or related indications, please?
Rakhu Ramsevaraju: Thanks so much for taking my questions and congratulations on all the progress on so many fronts.
Speaker Change: Firstly, I wanted to ask if you have some sense of...
Speaker Change: The Specific Clinical Indications.
Speaker Change: in which you expect.
Speaker Change: The Chronic Coffee Program.
Speaker Change: to proceed with highest probability.
Speaker Change: Clearly chronic cough is a serious symptomatic hallmark of many different.
Speaker Change: Respiratory, Pulmonary, and inflammatory diseases. But wanted to know which ones you consider to be particularly attractive and what we might expect to be the clinical path forward. For example, would you be considering advancement in COPD, or sarcoidosis, or related indications, please?
Raghuram Selvaraju: We haven't finalized the clinical patient population to AMAT. Currently, we are considering group artery and unexplained chronic cough, as well as possibility, but we are open to the ideas of also aiming at COPD or IPF related chronic cough, so this is still being discussed. Also, just from a clarification standpoint, I wanted to know whether you use the terms MED and ED50 interchangeably or not. No, MED is minimum effective dose and ED50 is a dose that reaches 50% of the effect. The confusion stems from the fact that sometimes they use the MED abbreviation to mean median effective dose, which is the same as...
Speaker Change: We have not finalized the clinical patient population to AMATs.
Speaker Change: Currently we are considering refructory and unexplained chronic cough as one possibility, but we are open to the ideas of also aiming at COPD or IPF related chronic cough. So this is still being discussed.
Speaker Change: Also, just from a scientific authority standpoint, I wanted to know whether you use the terms MED and ED50 interchangeably or not. No, MED is a minimum effective dose and ED50 is effective dose. Is it dose that reaches 50% of the effect?
Speaker Change: The confusion stems from the fact that sometimes they use the med abbreviation to mean media and effective dose, which is the same as ED 50. But if you use it as a minimum effective dose, then that explains how you are using those terms.
Raghuram Selvaraju: CD50. But if you use it as minimum effective dose, then that explains how you are using those terms. Also, I wanted to see if you had any commentary regarding what you expect to be the most appropriate comparator or competitor molecules that have historically been tested clinically in chronic cough, that you would look to be the benchmarks for your chronic cough program in the clinical context. We can consider Baccholfen and Lezogave; round those two have been tested in the clinic. They are clinical studies, and they are Galabiaganis, so would like to achieve similar, it's not better efficacy with improved tolerability, so that will be our pain.
Speaker Change: Also, I wanted to see if you had any commentary regarding what you expect to be the most appropriate.
Speaker Change: Comparator or competitor molecules that have historically detected clinically in chronic cough, that you would look to be the benchmark for your chronic cough program in the clinical context.
Speaker Change: We can consider Bakul Fern and as of our round those two have been tested in the clinic, there are clinical studies, and there are, um, rubber biagannis, so would like to achieve similar, it's not better efficacy with improved tolerability, so that's will be our aid aim.
Raghuram Selvaraju: But not Candlepixent, is that correct? Well, I think clearly we are expecting Candlepix to be standard of care by the time we get to later stage development, so we will be definitely looking to compare our compound with Candlepixent, absolutely. And we aim to reissue efficacy in a broader population of patients. As you know, up to 25% of patients do not respond to Candlepixent, and will be aiming to have a higher percentage of responders based on the mechanism. That we are using. Yeah, and I think probably many of the folks listening today will remember last year's transaction, which the developer of Candlepixent was acquired for $2 billion.
Speaker Change: But not Kamlapik sent, is that correct?
Speaker Change: Well, I think clearly we're expecting Kalinichev to be standard of care by the time we get, you know, to later stage development. So we will be definitely looking to compare, you know, our compound with Kalinichev and absolutely.
Speaker Change: and we aim to read.
Speaker Change: Chief Efficacine, a broader population of patients, as you know, up to 25% of patients do not respond to the sound of the sound and will be
Speaker Change: aiming to have a higher percentage of responders.
Speaker Change: Based on the mechanism that we are using.
Speaker Change: Yes, and I think probably many of the folks listening today will remember last year's transaction, which the developer of Kamli Pixen was acquired for $2 billion. So clearly, if you show broader efficacy, then Kamli Pixen, you know, that's potentially a very high value program.
Raghuram Selvaraju: So clearly, if you show broader efficacy, then Candlepixent, you know, that's potentially a very high value program.
Raghuram Selvaraju: I just wanted to ask also about some recent developments in the neurology neuropsychiatry space that may have applicability to the prospects of the neurosteric spinout. In particular, the label that was granted to Kobenfi, formerly known as CARXT, which was developed by Corona Therapeutics, which subsequently was acquired by Bristol. So I was wondering if there are any takeaways you got from looking at the label for Kobenfi that may provide more of an opportunity within the schizophrenia context, particularly with regard to the prospects for the M4 positive allosteric modulator. Well, we haven't yet had a chance to have a good look through the label.
Speaker Change: Just wanted to ask also about some recent developments in the neurology neuropsychiatry space that may have applicability to the prospects of the neuropsteric spin-out.
Speaker Change: In particular, the label that was granted to Kobenfi, formerly known as Karekst, which was developed by coronavirus and which subsequently was acquired by Bristol. So I was wondering if there are any takeaways you got from looking at the label for Kobenfi that may provide more of an opportunity within the schizophrenia context.
Speaker Change: particularly with regard to the prospects for the M4 positive ally steric modulator.
Speaker Change: I think he's...
Speaker Change: may
Speaker Change: Well, we haven't yet had a chance to have a good look through the label, but what we do know is that it's quite a broad label, and therefore this loads very well for other M4 compound that are going to come up for regulatory approval.
Raghuram Selvaraju: But what we do know is that it's quite a broad label, and therefore this bodes very well for, you know, other M4 compounds that are going to come up for regulatory approval. Yeah. And in that context, you, I believe, have also previously indicated that the pharmacophore and question that you folks are working on with regard to M4 modulation is distinct from the M-rackling pharmacophore, is it not? Yes, correct. It's a novel chemistry completely different from any described M4 chemistry that's out there, whether it's the M-rackling program or any of the other M4-PAM programs, so that all chemistry is different.
Speaker Change: [inaudible]
Speaker Change: [inaudible]
Speaker Change: And in that context, I believe have also previously indicated that the Pharmacophore and question that you folks are working on with regard to M4 modulation is distinct from the emiraclidean Pharmacophore, is it not?
Speaker Change: Yes, correct. It's a novel chemistry completely different from any described in the four chemistry. It's out there, whether it's the Emberatcladine program or any of the other M4 Pam programs without their art chemistry is different.
Raghuram Selvaraju: Yeah.
Raghuram Selvaraju: Can you just refresh my memory with respect to when you anticipate the first of the Neurosderic's portfolio compounds to potentially complete IND-enabling studies? Yeah, so we're on track to complete the IND-enabling studies in the middle of next year and rapidly file the IND so that we can move into phase one in the second half of 2025.
Speaker Change: Can you just refresh my memory with respect to when you anticipate the first of the neurosterex portfolio compounds to potentially complete IND enabeling studies?
Speaker Change: So we're on track to complete the I&D enabling studies in the middle of next year and rapidly file the I&D. So that we can move into phase one at the second half of 2025.
Raghuram Selvaraju: I'm not sure if you're in a position to speculate at this juncture regarding the prospects for a public listing of Neurosderic itself. I'm certainly not at liberty to talk about the strategy of Neurosderic's on this conference call. I'm afraid.
Speaker Change: Not sure if you're in a position to speculate that this juncture regarding the prospects for a public listing of neurosurrics itself.
Speaker Change: I'm certainly not that liberty to talk about the strategy of nearest Derek's on this conference call.
Raghuram Selvaraju: Thank you very much for taking my questions. Appreciate it. Thanks, Raghuram. Thank you.
Speaker Change: Thank you very much for taking my questions, appreciate it. Thanks.
Operator: Dear participants, as a reminder, if you wish to ask a question over the phone, please press star 111 on the telephone keypad and wait for a name to be announced. Alternatively, you can submit your questions via the webcast. Dear speakers, we'll just give a moment to our participants to press star 11, or just to ask the question on the webcast. Just give us a moment. Thank you. Thank you, ladies and gentlemen.
Speaker Change: Thank you.
Speaker Change: Dyer, participants as a reminder if you wish to ask a question of the phone please press star 1 1 on the telephone keypad and wait for an aim to be announced alternatively you can submit your questions via the webcast.
Speaker Change: The SP is going to give a moment to our participants to press 1-1, or just to ask the question on the webcast. Just give a moment. Thank you.
Speaker Change: each s don address
Speaker Change: [inaudible]
Timothy Dyer: This brings the main part of our conference to a close, and I would now like to hand back to Tim Dyer for closing remarks. So thank you everyone for attending our half-year 2024 conference call. And we look forward to speaking to you again soon.
Speaker Change: Thank you ladies and gentlemen, this brings the main part of our conference to a close and I would now like to hand back to Tim Dyer for closing remarks.
Operator: That concludes our conference for today. Thank you for participating.
Speaker Change: i
Operator: And now all disconnect. Have a nice day.
Speaker Change: Ladies and gentlemen, we have a conference for today. Thank you for participating, but now all this can act have a nice day.
Speaker Change: [inaudible]
Speaker Change: [inaudible]
Operator: Hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, 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hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey, hey Thank you very much for your time, and I'll see you in the next video.
Speaker Change: Okay.
[music].
Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Uh huh.
Speaker Change: Yes.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: So.
Speaker Change: Hum.
Speaker Change: [music].
Speaker Change: Okay.
[music].
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change:
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
[music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Hum.
[music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Uh huh.
Speaker Change: [music].
Okay.
Speaker Change: So.
Speaker Change: Hum.
Speaker Change: [music].
Speaker Change: Sure.
Speaker Change: Okay.
[music].
Speaker Change:
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yeah.
Speaker Change: [music].
Speaker Change: So.
Speaker Change: Hmm.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yeah.
Speaker Change: [music].
Okay.
Speaker Change: [music].
Speaker Change: So.
Speaker Change: Hmm.
Speaker Change: [music].
Sure.
Okay.
Speaker Change: [music].
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Raghuram Selvaraju: Raghuram Selvaraju, Leonildo Delgado, Raghuram Selvaraju, Leonildo Delgado, Mikhail Kalinichev,