Q1 2024 Addex Therapeutics Ltd Earnings Call
Okay.
Operator: Good day, and thank you for standing by. Welcome to the Addex Therapeutics first quarter 2024 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 need to press star 11 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 IDEXX Therapeutics first quarter 2020, full financial results and corporate update conference call.
Speaker Change: This time all participants are in listen only mode. After the speaker's presentation, there will be question and answer session.
Speaker Change: To ask a question during the session you need to press star one bond on the telephone keypad you would've here I know somebody's message advancing your hand is right to.
Speaker Change: To withdraw your question. Please press star one again.
Speaker Change: It tends to be you can submit your questions via the webcast.
Operator: To withdraw a question, please press star 11 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 your first speaker today, Tim Dyer.
Speaker Change: Please be advised that today's conference is being recorded.
Timothy Mark Dyer: I would now like to hand, the conference over to your first speaker today, Tim di Please go ahead.
Timothy Mark Dyer: Hello, everyone. I'd like to thank you all for attending our Q1 2024 Financial Results Conference call. I am here with Misha Kalinichev, our Head of Translational Science, who will provide an update on our R&D program. Thank you.
Speaker Change: Hello, everyone I'd like to thank you all for attending our Q1 2020 full bunch results conference call.
Speaker Change: I'm here with Michel <unk>, Jeff I'll head of translational science, who will provide an update on our R&D programs.
Speaker Change: Your attention to the press release and the financial statements issued earlier today, which are available on our website.
Timothy Mark Dyer: 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. I will start this conference call by giving a quick overview of our recent activities and achievements before reviewing our pipeline. I will then hand over to Misha who will review in more detail some of our clinical and preclinical programs, and I will then speak about the recent launch of Neurosterics before reviewing the Q1 2024 full year financial results, following that we will open the call for Q&A.
Speaker Change: 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: Yeah.
Speaker Change: I will start this conference call by giving a quick overview of our recent activities and achievements before reviewing our pipeline.
Speaker Change: I will then hand over to Michelle who will review in more detail some of the uptake of preclinical programs all of that and speak about the recent launch Neurostar X before reviewing the Q1 'twenty 'twenty four for yet.
Speaker Change: Following that we will open the call for Q&A.
Timothy Mark Dyer: We've made great progress in our GABA-B positive allostate modulator program, which is funded by our partner Indivior, and we are on track for Indivior to select a drug candidate for advancing into IND-enabling studies at the end of this month. As a reminder, under the agreement with Indivior, we have the right to select our own drug candidate after they have selected their candidate and to develop it in eight reserve disease areas where Indivior is precluded from developing their own candidate. We have selected chronic cough and expect to complete preclinical characterization in the second half of 2024.
Michelle: We've made great progress in our Gaba positive allosteric modulator program, which is funded by our partner and give you. All are on track for D V O to select drug candidates advancing into R&D, enabling studies at the end of this month.
Michelle: As a reminder, under the agreement with <unk>, we have the right to select our own drug candidates.
Michelle: So they have selected that can do that and to develop it in eight reserve disease areas.
Michelle: D var is precluded from developing that can do that.
Michelle: We have selected chronic cough unexpected complete preclinical characterization and second half 2024.
Timothy Mark Dyer: We launched Neurosterix 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 data. As part of the transaction, we received 5 million Swiss francs and a 20% equity interest in Eurosteric.
Michelle: We launched near Hysterics with a series a financing round of 63 million led by perceptive advisors.
Michelle: This is an innovative financing transactions behind us with the resources needed to advance our preclinical portfolio without diluting our shareholders' interests.
Paul: Paul the programs.
Paul: As part of the transaction, we received 5 million Swiss francs at a 20% equity interest in your stomach secure.
Timothy Mark Dyer: Securing the balance sheet and retaining significant upside in the programs for our shareholders. I will speak more about this innovative financing transaction later in the presentation, our partner Janssen. Completed the Phase II Epilepsy Study, evaluating adjunctive ADX71149 administration in patients with focal-onset seizures with suboptimal response to levotiracetam or grivotiracetam.
Paul: Securing the balance sheet and retaining significant upsides.
Paul: Brands for our shareholders.
Paul: I will speak more about this individual financing transaction later in the presentation.
Speaker Change: Our partner Janssen.
Speaker Change: Police at the Phase two epilepsy study evaluating a junk chips AVX 7149 administration in patients with type loans that teachers with suboptimal response lepage roster travel pretty mature.
Timothy Mark Dyer: We reported top-line data in May, and unfortunately, the study did not achieve statistical significance for the primary endpoint of time for patients to reach baseline seizure count when ADX71149 was added to standard of care. We expect the full data set from the study in the second half of this year and will work with our partners to determine next steps for the program. Now for a quick review of our pipeline. As mentioned, 7-1-1-4-9 has reported top-line data, and we are expecting a full data set in the second half of this year.
Speaker Change: We reported top line data in May and Unfortunately, the study did not achieve statistical significance for the primary endpoint of time for patients to reach baseline seizure counts, but.
Speaker Change: Next up more than four nine without it stands a cat.
Speaker Change: We expect the full dataset from the study in the second half of this year and work with our policy to seven next steps for the program.
Speaker Change: Now for a quick review of our pipeline as mentioned.
Speaker Change: So my mom four nine as reported top line data and we are expecting full data set in the second half of this year.
Timothy Mark Dyer: We continue to believe in diprochlorant and are executing our plans to commence development in both dyskinesia associated with Parkinson's disease as well as preparing diprochlorant for a Phase II group concept study in post-stroke recovery. As mentioned, our GABA-B-PAM collaboration is coming to the end of the discovery phase, with drug candidates on track to start IND-enabling studies later this year. And Divio is executing the substance use disorder program, and we are preparing our candidate for development in chronic cough. Now I will hand over to Misha, who will give you some more details about our exciting portfolio.
Jim: We continue to believe in depth Clearone tanks excuse me our plans threat commence development of Jim but just can you just say you with Parkinson's disease as well as preparing for phase II proof of concept study in post stroke recovery.
Jim: As mentioned, our Gaba B Penn collaboration is coming to the end of the discovery phase with drug candidates on track to start Dave enabling studies later this year.
Jim: He always executing the substance use disorder program and we are preparing our candidate development in chronic cough.
Michelle: Now I will hand over to Michelle who will give you some more details about our exciting portfolio.
Mikhail Kalinichev: Thanks Tim. Hello everyone.
Michelle: Thank you Tim Hello, everyone I will start by speaking about it probably around in our cloud towards development in brain injury recovery.
Mikhail Kalinichev: I will start by speaking about the program and our plans for development in brain injury recovery. Following termination of the development of the program on D&P DELETE, we embarked on a detailed evaluation of a number of potential indications, future development, including substance use disorder, migraine, and other forms of pain. We have completed this exercise and have identified brain injury recovery as an interesting indication for the future development of deprep. We believe the differentiated profile of depregnum makes it particularly suitable for enhancing the impact of rehabilitation in traumatic brain injury and stroke patients.
Speaker Change: Following termination of the developmental to probably around GBP delete, we embarked on a detailed evaluation of a number of potential indications of interest for future development, including substance use disorder migrate and other forms of pain.
Speaker Change: We have completed this exercise and have identified brain injury recovery as an interesting indication or the future development of the property.
Speaker Change: We believe the differentiated profile are you pregnant makes it particularly.
Speaker Change: Suitable for enhancing the impact of rehabilitation in traumatic brain injury and stroke patients.
Mikhail Kalinichev: There is a large unmet medical need for post-stroke recovery and rehabilitation. 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 an annual rate of 12.
Speaker Change: So there's a large unmet medical need in post stroke rate recovery and rehabilitation stroke is among the leading causes of chronic orphan lifelong disability as it leads to motor sensory cognitive impairment and multiple comorbidities there are over 100 million stroke survivors.
Speaker Change: Worldwide and the number is growing at an annual rate of 12.
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 the recovery stimulated by rehabilitation therapy. The AMPlify receptor is a suitable target to address post-stroke recovery as it is densely expressed in the brain, involved in neuroplasticity, and modulates excitatory-inhibitory equilibrium. In fact, activation of MGOR5 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.
Speaker Change: A variety of rehabilitation therapies are used with post stroke patients, but the recovery slow and often inadequate there is an urgent need for pharmacological agents at Kansas facility, the recovery stimulated by rehabilitation of therapies.
Speaker Change: <unk> receptor is a suitable target to address post stroke recovery as it is densely expressed in the brain involved in neuroplasticity and modulate excitatory inhibitor equilibrium.
Speaker Change: <unk> activation of them were five has been observed in a range of neurological disorders, including stroke wage plays a role in so called maladaptive rewiring of the brain hauling stroke inhibition of them qualify on the other hand can facilitate adapter rewiring of the brain.
Mikhail Kalinichev: Inhibition of MGOR5, 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. Exciting new evidence recently published in the journal Brain suggests that the negative allosteric modulator of MgUR5, 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 daily with our glorified non-depressive therapy.
Speaker Change: Promoting neuroplasticity and creating new functional pathways moving the neural networks towards MP lesions states.
Speaker Change: Exciting new evidence recently published in the journal brain suggests that the negative allosteric modulator of EMCORE fives.
Speaker Change: Administered daily is rats following stroke resulted in a sustained and growing improvement in sensory motor function in comparison to vehicle treated.
Speaker Change: Similar improvement in sensory motor function was observed in animals treated daily with our five novelty products.
Mikhail Kalinichev: MRI imaging of resting state functional connectivity in post-stroke rodents shows that daily administration of MTAP also stimulates intra- and inter-hemispheric connectivity in the brain disrupted by stroke. It's important to know that improvement in brain connectivity after stroke is known to correlate with functional recovery and is observed across.
Speaker Change: MRI imaging of the resting state functional connectivity in post stroke products shows that daily administration of Amtech also stipulates intra and inter cemetery connectivity in the rain disrupted by stroke.
It's important to note that improvement in brain connectivity after stroke is known to correlate with functional recovery and as observed across species.
Mikhail Kalinichev: The primary rod 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 duration. It has shown good tolerability in healthy subjects and in Parkinsonian patients, showing only mild to moderate CNS-related adversities. The company has a drug product ready and a strong patent position and believes the program can become a first-in-class drug to facilitate post- We can also speculate that depregnated adaptive rewiring and facilitation of recovery following brain damage can also be seen in traumatic brain injury.
Speaker Change: The property is ideally suited to be used in tandem with radiation therapy infrastructure patients as it has a fast onset of action and short it has shown good tolerability in healthy subjects and in Pakistan in patients show with only mild to moderate <unk>.
Speaker Change: <unk> related adverse effects.
Speaker Change: We have a drug product ready and a strong patent position and believe the project can become a first in class drugs to facilitate post stroke.
Speaker Change: We can also speculate that deprived Europe began its adaptive the wiring and facilitation of recover its holiday break damage can also be seen in traumatic brain injury patients.
Mikhail Kalinichev: Let me now switch to the GABA-B positive ulcerative modulator preclinical program, which is partnered with Indeed. The aim of this collaboration is to deliver a new treatment for substance use disorders. 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 sources. As a reminder, GABA-B receptor activation has been clinically validated in a number of disease areas, including using Baclofen, a GABA-B orthosteric agonist.
Speaker Change: Let me now switch to Gaba positive allosteric modulator preclinical program, which is partnered with <unk>.
Speaker Change: The aim of this collaboration is to deliver a new treatment.
Speaker Change: For substance use disorders.
Speaker Change: Your is supporting the research at IDEXX and have recently committed an additional 2.7 billion Swiss francs funding for us to complete clinical candidate selection activities. In addition to $13 8 million Swiss francs towboat funding shortfall.
Speaker Change: As a reminder, Gaba receptor activation has been clinically validated in a number of disease areas.
Speaker Change: Using backwards, a Gaba b ultra series targets.
Mikhail Kalinichev: Baclofen is FDA approved for the 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 a better market.
Speaker Change: Our policy is FDA approved for treatment of spasticity and is widely used off label to treat numerous diseases, including substance use disorder.
Speaker Change: However, <unk> has a short half life and comes with significant side effects Humphery, it's wider use.
Speaker Change: Thus there is a strong need for a better backwards.
Mikhail Kalinichev: We believe this can be achieved with positive allosteric modulators and their differentiated pharmacology, having the efficacy of Baclofen but a longer half-life and an improved side-effect profile. We are well on our way to meeting this objective with multiple novel drug candidates, rapidly advancing through candidate selection, with the aim to nominate drug candidates ready to enter ID-enabling studies in H2 2024. As part of our agreement with Indivio, we have the right to select drug candidates from the funded research activities for our own independent WB-PAM program.
Speaker Change: We believe this can be achieved with positive allosteric modulators and their differentiated pharmacology, having the efficacy of buckler said, but longer half life and improved side effect profile.
Speaker Change: We are well on our way to meeting this objective with multiple novel drug candidates rapidly advancing through candidate selection sites with the aim to nominate drug candidate ready to enter I'd, enabling studies in <unk> 'twenty 'twenty four.
Speaker Change: As part of our agreements was indeed, we have the right to select drug candidates from the funded research activities for our own independent Gaba B.
Mikhail Kalinichev: We have selected to focus our independent program on COVS, and therefore, I will present this exciting, There is a strong rationale for developing GABA BPAMs for chronic cough. Chronic cough is a persistent cough that lasts for more than eight weeks and can be caused by a variety of factors including respiratory infections, asthma, allergies, and acid reflux, but also possible by an overactive cough reflex.
Speaker Change: Graham.
Speaker Change: We have selected to focus our independent program on pulp and therefore, our present this exciting opportunity.
Speaker Change: There is a strong rationale for developing <unk> for chronic cough chronic cough is a persistent coughs that lasts for more than eight weeks and can be caused by a variety of factors, including respiratory infections asthma allergy acid reflux, but also possibly by an overactive.
Mikhail Kalinichev: There is a large unmet medical need for novel antitrustive drugs, as current standards of care are ineffective in 30% of cases or only moderately effective in up to six. In addition, the current treatments carry risks of serious side effects. On the next slide, we show that GABABPAMs are likely to have a superior tolerability profile in comparison to the current standard of care and show no taste-related side effects, as seen with the newly-approved P2X3 inhibitor, Geharin.
Speaker Change: Cough reflex.
Speaker Change: There's a large unmet medical needs in global antitrust suit drugs as current standards of care are ineffective and 30% of patients or only moderately effective in up to 60% of the patients. In addition, the current treatments carry risks of serious side effects.
Speaker Change: On the next slide we show that W patterns are likely to have a superior tolerability profile in comparison to the current standards of care and showed no case related side effects as seen was a newly approved pizza extreme cubature genoptix.
Mikhail Kalinichev: Support for using GABA-B PAMs in 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 guava bean receptors are strongly expressed in airways and in the neuronal pathway regulating, Therefore, we believe that Gabavit Pads could offer superior efficacy in cold patients. Thus, we believe that GABA-B PAMs 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.
Speaker Change: Support for using double the tabs in treatment of chronic cost comes from the clinical evidence with Buckler said a couple of the agonist is used off label in cough patients and from anatomical evidence in Tel Aviv receptors are strongly expressed in airways and in the new logo.
Speaker Change: <unk> regulated cost therefore, we believe that doubled with hounds who'd offer superior efficacy in qualifications.
Speaker Change: Okay.
Speaker Change: Thus, we believe that <unk> could be an innovative new treatment of chronic cough administered once daily oral dosing and offering improved efficacy and tolerability with fewer non responder patients suitable for chronic dosing, therefore significantly improving patients.
Mikhail Kalinichev: We are working with multiple compounds progressing in the late clinical candidate selection phase, and we expect to move into IUD-enabling studies in H2 2024, in parallel to delivering compounds for our partner in DFU. This concludes our prepared remarks on the progress of our R&D program. Now I hand it back to Tim. Thanks, Misha.
Speaker Change: We are working with multiple compounds progressing as late clinical candidate selection phase and we expect to move into IND, enabling studies and <unk> before in parallel to delivering compounds for our partner.
Speaker Change: This concludes our prepared remarks on the progress of our R&D programs now I hand, it back to Tim. Thanks.
Timothy Mark Dyer: Thanks, Misha. Now, before I move on to the financials, I would like to spend a few moments speaking about the New Esterix transaction. Due to the excellent progress made by our R&D team in advancing our unpartnered preclinical portfolio, our M4-PAM, our 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, given the low market capitalization of Addex, raising the amount of capital needed would have been extremely challenging and highly diluted to our shareholders.
Tim: Thanks, Michelle now before I move on to the financials I would like to spend a few moments to speak about the nearest eric's transactions.
Tim: Due to the excellent progress made by our R&D team in advancing our own polymer preclinical portfolio are in full Pam RMB lost seven Nam and am law two not programs reached the stage of development, where they now need significant amounts of financing to progress into the clinic.
Tim: Given the low market capitalization about ex raising the amount of capital needed would have been extremely challenging and highly dilutive to our shareholders. So we decided to spin out of these programs and our platform into a new private company and raise the necessary capital directly into the new company.
Timothy Mark Dyer: So we decided to spin out these programs and our platform into a new private company and raise the necessary capital directly into the new private company. We believe this is an excellent transaction for Addex shareholders as it has secured $5 million for Addex and removed the financing overhang on the Addex stock. We have retained a 20% interest in Neurosterics, 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 Allosteric Modulator technology platform, including the majority of our staff, and have retained all we have retained.
IDEXX: We believe this is an excellent transaction for IDEXX shareholders. As it has secured 5 million for IDEXX and removed the financing overhang on the attic stock.
Derrick: We have retained 20% interest in euro as Derrick said, 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 and best Syndicate led by Perceptive advisors.
Speaker Change: As part of the transaction, we have diverse allosteric modulator technology platform, including the majority of our staff how about we have retained.
Timothy Mark Dyer: 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. Now for the review of the Q1 2024 financials. Following the Eurostarix transaction, we were required under the IFRS standards to identify continuing operations related to the retained programs and Discontinued Operations related to the operations and programs that were sold to Neurosterix. All income and expense items related to discontinuing operations have been reclassified under a specific line of the Comprehensive Loss Call of Net Loss from Discontinued Operations.
nearest airings: However, we have entered into a service agreement with nearest airings to ensure that we can access the skills needed to execute on our business strategy.
Timothy Mark Dyer: Starting with the income statement, which relates to continuing operations, we recognize 0.2 million of revenue in Q1 2024 compared to 0.5 million in Q1 2023. The primary source of revenue is research funding from our collaboration with Indivio, which is recognized as the associated research costs are incurred. Continuing R&D expenses primarily relate to our GABA BPAM program and remain stable at 0.3 million in Q1 compared to Q1 2023. Continuing operations and G&A expenses were $0.8 million compared to $0.6 million in Q1 2023. The increase of 0.2 is primarily due to legal fees related to the NeuroClerics Transact.
Speaker Change: Now for the review of Q1 2020 for financials. Following nearest tax transaction, we were required under the <unk> standards to identify continuing operations related to the retained programs.
Speaker Change: Discontinued operations relate to the operations and programs that was salt near Hysterics, all income and expense items related to discontinuing operations have been reclassified under a specific line of the comprehensive loss called net loss from discontinued operations.
Speaker Change: Yes.
Speaker Change: Starting with the income statement, which relate to continuing operations. We recognized 0.2 million of income in Q1 trend straightforward competitive zero point $5 million in Q1 'twenty to 'twenty three the primary source of revenue is research funding from a collaboration within gave you which is recognized as the associated.
Speaker Change: Research costs are incurred.
Speaker Change: Continuing R&D expenses, primarily relate to our GAAP or be Pam program and remained stable at <unk> 3 million in Q1 compared to Q1 2023.
Speaker Change: Continuing operations and G&A expenses.
Speaker Change: $4 8 million.
Speaker Change: Compared to <unk> 6 million in Q1 trains train three increased 0.2 is primarily due to legal fees related to the nearest generics transaction.
Timothy Mark Dyer: Finance results in Q1 2024 are primarily related to foreign exchange gains on cash held in US dollars and, to a lesser extent, to interest income on US dollar cash deposits. Now to the balance sheets. Our assets are primarily held in cash, and we completed Q1 with 1.6 million Swiss francs of cash held in Swiss francs and US dollars. Gross proceeds of 5 million from the Neurosterix transaction will be received in April 2024, so are not included in this figure.
The finance results in Q1, 'twenty 'twenty four is primarily relates to foreign exchange gains on cash held in U S dollar and to a lesser extent to interest income all of the U S dollar cash deposit.
Timothy Mark Dyer: Other current assets amount to $0.8 million, primarily related to prepaid retirement benefits annually paid at the beginning of the year, due to the neuro-steroids transaction we expect. 0.6 million of this amount to be reimbursed in Q2 of this year. Current liabilities of £3.3 million as of March 31st 2024 increased by £0.4 million. [inaudible] Non-current liabilities of 0.1 million decreased by 0.5 million compared to December 31, 2023, primarily due to staff transferred to Neurosteric.
Speaker Change: Now to the balance sheets.
Speaker Change: Our assets are primarily held in cash.
Speaker Change: We completed Q1, $1 6 million Swiss francs attach held in Swiss francs in U S dollars.
Speaker Change: Gross proceeds of 5 million from the nearest tax transaction.
Speaker Change: <unk> received in April 2024, so are not included in this figure.
Speaker Change: Other current assets amounted to <unk> 8 million, primarily related to prepaid retirement benefit annual annually paid at the beginning of the year.
Speaker Change: Due to the nearest <unk> transaction, we expect <unk> 6 million of this amount to be reimbursed in Q2 of this year.
Speaker Change: Yes.
Speaker Change: Current liabilities of $3 3 million as of March 31st 2024 increased $5 4 million compared to a like periods.
Speaker Change: Like a date to pay previous year.
Speaker Change: And primarily relate to cri related accruals and payables non current liabilities of $1 million decreased.
Speaker Change: $5 5 million compared to December 31, 2023, primarily due to this stock handset to near Hysterics.
Timothy Mark Dyer: Now to summarise, I hope you have understood how transformative the Neosterix deal is for Addex. We've strengthened the balance sheet and secured the financing to execute on the development of our preclinical portfolio, including the M4 PAM programme for schizophrenia, into the clinic, and our partnership with Indivio is on track to deliver clinical candidates ready for R&D enabling studies by the end of this year. DIPRAGLON is ready to restart clinical development and is subject to a number of partnering discussions.
Speaker Change: Now to summarize I hope you have understood how transformative the nearest tax dailies for IDEXX, we have strengthened the balance sheet unsecured financing to execute on the development of our preclinical portfolio, including M for Pompe program for schizophrenia in the clinic and a partnership with <unk> is on track to deliver clinical candidates ready find DNA things.
Speaker Change: Studies by the end of June this year deploying is ready to restart clinical development.
Speaker Change: And the subject to a number of partnering discussions.
Timothy Mark Dyer: Our independent GABA B cold program is also on track to start R&D enabling studies. We are validating partnerships with industries, supportive investors, and a strong balance sheet, which puts us in a solid position to deliver on our strategy. Jeff Sessions. This concludes the presentation, and we will now open the call for questions. Thank you.
Speaker Change: Our independent Gaba B cost program is also on track to start IND, enabling studies.
Speaker Change: We have validated pumps, so industries for the investors 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.
Operator: Thank you. Dear participants, as a reminder, if you wish to ask a question over the phone, please press star 11 on your telephone keypad and wait for your name to be announced. To withdraw a question, please press star 11 again. Alternatively, you can submit your questions via the webcast. Please stand by; we'll compile the Q&A roster. This will take a few moments. And now we're going to take our first question, and it comes from the line by Leonilda Delgado from Bader Halver. Your line is open; please ask your question.
Speaker Change: Thank you Dear participants as a reminder, if you wish to ask a question over the phone. Please press star one on the telephone keypad and Lake finance to be announced until we drew a question. Please press star one again.
Tentatively yoga habitual questions via the webcast.
Speaker Change: Bob will compile the Q&A, Mr. Earl studies will take a few moments.
Speaker Change: Okay.
Speaker Change: And now we'll go and take our first question.
Speaker Change: And it comes from the line of the Aneel the Delgado from BARDA, how that your line is open. Please ask your question.
Leonilda Delgado: Hi, good afternoon. Thanks for taking my questions. A couple of questions on my side. In addition to the... to the $5 million upfront payment, should we expect more of cyphaladic when it comes to Neurostatics? And so, when would Addex be able to capitalize on the 20% equity interest? And so, how big would the opportunity be?
Speaker Change: Hi, good afternoon. Thanks for taking my questions a couple of questions from my side.
Speaker Change: Leadership.
Speaker Change: Yeah.
Speaker Change: 5 million upfront payment or should we expect more upside for IDEXX.
Speaker Change: He comes to a near steady.
Speaker Change: And so.
Speaker Change: When would IDEXX be able to capitalize on 40% equity interest.
Speaker Change: So our peak would be opportunity can be.
Timothy Mark Dyer: The $5 million is being received in Q2. Addex has retained its 20% interest in Neurosterix. Neurosterix has got $60 million on its balance sheet at the post-money valuation of Neurosterix, basically just south of 100, so the value at the date of the transaction of the 20% is about $20 million. Now, regarding upside...
Speaker Change: Okay. Thanks question, yes. So.
Speaker Change: So the 5 million, yes, it's being received in <unk> has been received in Q2 and Alex has retained a 20% interest in euro as derek's nearest derricks and has got a.
Alex: $60 million on its balance sheet and the post money valuation of nearest derricks.
Alex: Basically just south of 100 side the value.
Alex: At the date the action of the 20%.
Alex: It's about $20 million.
Alex: And.
Alex: Now regarding upside.
Timothy Mark Dyer: There was a sale of the carved out entity, and there are no milestones and royalties on any of the products that were divested into Neurosteric. So the upside for Addex is in its equity interest in Neurosteric. And I mean, there are a number of them.
Alex: There was a sale of the carved out entity and there are no.
Speaker Change: Milestones and royalties on any of the products that were divested engineers Derrick so.
Speaker Change: The upside for IDEXX is in its equity interest in U S. Eric's.
Speaker Change:
Speaker Change: And I mean.
Speaker Change: There's a number of them.
Speaker Change: In a recent deals around the muscarinic Kevin for example.
Speaker Change: People, Sarah valves, $8 7 billion.
Speaker Change: BMS or Korean or at the end of last year for 14 billion.
Speaker Change: I think the most relevant comparator is that Cerro del.
Timothy Mark Dyer: You had an M4-PAM; the M4-PAM had just started phase two. And what's interesting for Neurosterics is the cash that's on the Neurosterics balance sheet finances the M4-PAM all the way through to a stage very close to where Cerebell was with their M4-PAM program. I wouldn't want to speculate about the value upside, but I think you can make your own conclusions that there is significant upside for Addex in that 20% of Neurosterics because Neurosterics is well funded and financed to meet some very significant value inflection points, being the advancing of one or two programs into the clinic through phase one. I hope that answers your question.
Speaker Change: It had an M for Pam the M for Pam had complete had just started phase III.
Speaker Change: And what's interesting and for Neurostar acts as the cash that's on the nearest Derek balance sheet.
Finance is the handful Pam.
Speaker Change: Way through to a stage are very close to where Sarah about was with their full patent program.
Speaker Change: So I wouldn't want to speculate about the value upside, but I think you can you can make your attic indications that there is significant upside for IDEXX in that 20% of nearest Derrick because nearest Derek is well funded and financed to meet some very significant value inflection points.
Speaker Change: Being the advancing of one or two.
Speaker Change: Programs into the clinic.
Speaker Change: And through phase one.
Speaker Change: I hope that answers your question.
Leonilda Delgado: Thanks a lot. Maybe one final question. On the epilepsy program, when do you think Janssen will communicate its plans for the ADX71-149? Yeah, so as I mentioned, you know, we've seen the top line.
Speaker Change: Doctors can collect maybe one final question on the epilepsy program. When do you see Johnson will communicate explants for the <unk> 70 149.
Timothy Mark Dyer: Yeah, so, as mentioned, you know, we've seen the top-line results. Unfortunately, the primary endpoint was not met, and we are now doing a full analysis, or Janssen is doing a full analysis of the full data set, and we are expecting to receive the full data set and the full analysis and have discussions with them about it. I mean, we're talking about H2, you know, we're very hopeful it will come earlier in H2, given the timelines to do this, it should come in Q3, we would have thought, and then we will work with Janssen to work out how best to move the program forward.
Speaker Change: Yeah. So.
Speaker Change: As mentioned, we've seen the top line results. Unfortunately.
Jan: The primary endpoint was not met and we are now doing a full analysis or Jan said not during a full analysis of the full data set.
Jan: And we are expecting to receive.
Jan: The full data set in the full analysis and have discussions with them.
Jan: Yes.
Jan: I mean, we're talking about H two.
Jan: We're very hopeful.
Jan: Here in H two.
Jan: Given the time lines to do this it should it should come in Q3, we would have thought and then we will work with Janssen to work out.
Jan: How best to move the program forward are clearly one option, which is you know.
Timothy Mark Dyer: Now, clearly, one option which is, you know, reasonably, you know, possible is that the collaboration gets terminated, and Addex receives back the molecule and all the backup molecules as well. So, you know, this is one of the, you know, I would say reasonably probable outcomes. Once the full data set has been reviewed, but again, until we see the full data set, we can't really fully understand whether there is a way forward in epilepsy or not. Okay, thank you.
Jan: Reasonably.
Jan: Possible is that the the collaboration gets terminated and and IDEXX received back then.
Jan: The molecule.
Jan: And all the backup molecules as well.
Speaker Change: So this is a is one of the.
Speaker Change: I would say reasonably probable.
Speaker Change: Outcomes.
Speaker Change: Once the full dataset.
Speaker Change: Has been reviewed but again until we say to you the full dataset.
Speaker Change: We can't really fully understand.
Speaker Change: Whether there is a way forward in epilepsy or not.
Speaker Change: Okay. Thank you.
Speaker Change: Thank you.
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. Once again, if you wish to ask a question, please press star 11. Thank you, ladies and gentlemen. This brings the main part of our conference to a close, and I would now like to hand over to Tim Dyer for his closing remarks.
Speaker Change: Okay.
Speaker Change: Yeah participants as a reminder, if you wish to ask a question over the phone. Please press star one on the telephone keypad. Alternatively, you could submit your questions why the webcast.
Speaker Change: Once again, if you wish to ask a question. Please press star one bank.
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 for closing remarks.
Timothy Mark Dyer: Well, thank you very much, everyone, for attending the Q1 2024 conference call, and we look forward to speaking to you again soon. Have a very nice day.
Speaker Change: Sure.
Tim: Well. Thank you very much everyone for attending the Q1 2020 full conference call and we look forward to speaking with you again soon.
Tim: Have a very nice day.
Operator: That does conclude our conference for today. Thank you for your participation. You may now all disconnect. Have a nice day.
Speaker Change: That does conclude our conference for today. Thank you for your participation you may now disconnect have a nice day.
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