Q4 2024 Addex Therapeutics Ltd Earnings Call
Speaker Change: Good day and thank you for standing by. Welcome to the Addex Therapeutics full-year 2024 financial results and corporate update conference call. At this time, Opatis Penta in listen only mode. After this biggest presentation, there will be the question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone keypad. You will not hear an automated message advising your hand is raised.
To withdraw a question, please press star 1-1 again.
Speaker Change: If you wish to ask a question via the webcast, please use the Q and A box available on the webcast link at any time during the conference.
Please be advised to the conference has been recorded.
Speaker Change: I would now like to hand a conference over to our first speaker today, Tim Dyer, please go ahead.
Tim Dyer: Thank you. Hello everyone. I would like to thank you all for attending our 2024 full-year financial results conference call. I'm here with Mikhail Kalinichev, our Head of Translational Fund. We will provide an update on our R&D programmes.
Speaker Change: I draw your attention to the press release and the financial statements issued earlier today which are available on our website.
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: 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 Misha, who will review in more detail our M-Global 5 Negative Ballastote Modulator Programme for Brain Injury Recovery, and our GABAB Positive Ballastote Modulator Pre-Tinical Programme for Coalth.
Thank you. Thank you. Thank you.
I will then review our 2024 full year financial results.
Following that, we will open the call to Q&A.
Thank you.
Speaker Change: We have made excellent progress in our GABAB PAM program with the completion of the R&D phase delivering multiple drug candidates.
Speaker Change: Our partner, Indivior, has selected a compound for development in substance use disorders and has started IND-enabling studies. We expect to be able to announce results from these studies soon.
Speaker Change: Under the terms of the agreement, Addex is eligible for payment of up to $330 million US dollars on successful achievement of...
Speaker Change: Pre-specified regulatory clinical and commercial milestones, as well as tiered royalties on the level of net sales from high single digits up to low double digits.
Speaker Change: Also, under the terms of the agreement, we have the right to select compounds for development in a predefined list of reserved indications.
Speaker Change: We have selected a compound to advance our own independent Gava V-Pam program for the treatment of chronic cough. We have substantially completed the pre-thinkable profiling of our compound for chronic cough and are currently working to secure funding to advance this program into the IND and ATLINK studies.
Speaker Change: Misha will be sharing some of this data with you later in our presentation.
Speaker Change: We have repositioned different neurons, our M-5 negatives don't modulate for brain injury recovery and currently completing negotiations to access intellectual property covering the use of M-5 inhibitors in this interesting therapeutic indication.
Speaker Change: which we will also talk more about this exciting program later in the presentation.
Speaker Change: Following the decision last year by our partner, Johnson Johnson, to terminate development of ADX 71149, we have regained the rights to this phase two asset with a high value of data set and significant materials.
Raghuram Selvaraju, Leonildo
Speaker Change: We have completed the year with 3.3 million Swiss francs of cash, which provides us with the cash runway through mid-2026.
Speaker Change: I'd like to highlight that the cash burn has been significantly reduced following the nearest Derek Spinnell transaction. However, current cash does not fund the progression of our und-partner programs into the clinic.
Speaker Change: Our partner in digital have selected a Gaba Pam drug candidate development substance use disorders and started on and do that your studies.
Speaker Change: We are advancing an independent Gaba Pam program for chronic cough and expect to start R&D, enabling studies this year subject to securing financing.
Speaker Change: And <unk> has made excellent progress in advancing its pipeline, including starting R&D, enabling studies with <unk> and full time programs.
Speaker Change: Now I will hand over to Michelle who will give you some more details about our exciting portfolio.
Michelle: Thanks, Tim.
Michelle: Hello, everyone I will start by speaking about <unk> and our plans for development in brain injury recovery.
Michelle: Following termination of the development of department around NPD lead we embarked on a 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.
Michelle: We believe the differentiated profile of the product makes it particularly suitable for enhancing the impact of rehabilitation in traumatic brain injury and stroke patients.
Michelle: There is a large unmet medical need in post stroke recovery and rehabilitation.
Michelle: <unk> is among the leading causes of chronic orphan lifelong disability.
Michelle: It leads to motor and sensory cognitive impairment and multiple comorbidities. They are over 100 million stroke survivors worldwide and the number is growing at the annual rate of $12 million.
Michelle: A variety of rehabilitation therapies are used with post stroke patients, but the recovery is slow and often inadequate.
Michelle: There is an urgent need for pharmacological agents that can facilitate the recovery stimulated by rehabilitation service.
Michelle: In Blue are five receptor is a suitable target to address post stroke recovery as it is densely expressed in the brain involved in euro plasticity and modulate excitatory inhibitory equilibrium.
Michelle: In fact Activations have war five has been observed in a range of neurological disorders, including stroke, where it plays a role in maladaptive rewiring of the brain following strong inhibition of Hanwha life on the other hand can facilitate adaptive rewiring of.
Michelle: The brain promoting neuroplasticity and creating of new functional pathways moving the neural network towards the Elysian States.
Michelle: Exciting new evidence recently published in the journal brain suggests that the negative allosteric modulator overqualified Amtech admins.
Michelle: Administered daily in Red following stroke result, in a sustained and growing improvement in sensory and motor function in comparison to vehicle treatment.
Michelle: Similar improvement in sensory and motor function was observed in animals treated with our <unk> now you're pregnant.
Michelle: MRI imaging of the resting state functional connectivity in post stroke products shows the daily administration of Amtech also stimulate intra and inter emissary connectivity in the brain disrupted by stroke.
Michelle: It is important to note that improvement in brain connectivity. After stroke is known to correlate with functional recovery and as observed across species.
Michelle: The primary ramp 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 is as showed good tolerability and houses subjects and in Pakistan in patients.
Michelle: Showing only mild to moderate CNS related adverse effects.
Michelle: We have a drug product ready and a strong patent position and.
Michelle: I believe the program can become a first in class drug to facilitate post stroke recovery. We can also speculate that the prevalent.
Michelle: Mediated adaptive rewiring and facilitation of recovery following brain damage would also be seed in traumatic brain injury patients.
Michelle: Let me now switch to our Gaba B positive our steric modulator program, which is partnered with <unk>. The aim of this collaboration is to deliver a better baclofen for substance use disorders.
Michelle: As a reminder, Gaba b receptor activation has been clinically validated in a number of disease areas using backwater cover be auto steric agonist.
Michelle: <unk> is an FDA approved drug for treatment of spasticity and is widely used off label to treat numerous diseases, including substance use disorders and others. However, baclofen has a short half life and comes with significant side effects hampering its wider use.
Michelle: Thus there is a strong need for a better backlog.
Michelle: We believe this can be achieved with positive allosteric modulator approach and differentiated pharmacology, having the efficacy of baclofen, but longer half life and improved side effect profile.
Michelle: Our partner <unk> has selected oncology drug candidate for development in substance use disorders and started IND, enabling studies.
Michelle: As part of our agreement with any of your IDEXX has exercised its right to select a compound to advance its own independent company program for the treatment of chronic cough.
Michelle: I will now present this exciting opportunity.
Michelle: There is a strong rationale for developing <unk> for chronic cough.
Michelle: Chronic cough is a persistent calls that lasts for more than eight weeks and can be caused by a variety of factors, including respiratory infections asthma allergies in essence reflects but also possibly by the overactive cough reflex.
Michelle: There is a large unmet medical need in novel anti <unk> drugs as current standards of care are ineffective in 30% of patients or only moderately effective in up to 60% of patients. In addition, the current treatments carry risks of serious side effects.
Michelle: On the next slide we show that <unk> are likely to have a superior tolerability profile in comparison to the current standard of care and show no taste related side effects as seed was the newly approved to excrete inhibitor give up itself.
Michelle: Support for using <unk> in treatment of chronic cough comes from the clinical evidence that uplift.
Michelle: Is used off label in cough patients and from the anatomical evidence that Gaba B receptors are strongly expressed in airways and in the neuro pathway regulating cough.
Michelle: Therefore, we believe that Gaba Pam could offer superior efficacy in <unk> patients.
Michelle: The pre IND activities, including in vivo proof of concept non GOP talks and CMC has been completed and our clinical candidate has shown favorable efficacy tolerability and develop ability profiles.
Michelle: Our clinical candidate has demonstrated a consistent minimum effective dose of one Nick boutique and <unk> of 6 million per kick in cough frequency no signs of colors were seen after subtracting dosing and more than 30 fold safety margin was demonstrated based on tolerability.
Michelle: <unk> Biomarkers.
Michelle: The IND, enabling studies are planned to start this year.
Michelle: The next set of slides describes the in vivo proof of concept studies in models of course.
Michelle: In the model of citric acid induced coffee D peaks acute we administered compound a delay.
Michelle: <unk> delivered a robust antitumor activity profile, reducing the cost number and increasing the latency to first call.
Michelle: The antigen profile of backward presents a model where the world was more modest as coke latency remained largely unchanged.
Michelle: In the same experiment compound day was better tolerated tobacco side as there were no marks changes in respiratory rate rate body temperature and plasma concentration of growth hormone is up to 60 mixed breed kick in contrast, baclofen suppress respiratory rate reduced both the temperature by.
Michelle: Two degrees Celsius, and increase growth hormone concentrations in plasma starting street mixed repeat dose. Thus we believe we achieved our goal to discover at Metro Park Plaza for costs.
Michelle: Intermodal citric acid induced coffee Guinea pigs, so chronically administered compound they showed signs of improved efficacy and potency and no signs of tolerance in comparison to an acute treatment.
Michelle: As expected science related to safety and Tolerability of compound they remain largely unchanged and the sub chronic versus acute treatment regiments.
Michelle: In the model of ATP potentiate citric acid coffee D peaks in a head to head comparison experiment acutely administered compound.
Michelle: And the <unk> inhibitor.
Michelle: Similar efficacy and Tolerability profiles.
Michelle: In summary, we have selected our clinical candidate for chronic cough with a robust reproducible antitumor efficacy of one extra kick at good PK PD.
Michelle: Compound showed a favorable develop ability profile in non GOP Tox studies performed in rats dogs and non human primates.
Tim Dyer: Our track to stop start IND, enabling studies. This year. This concludes our prepared remarks, the progress R&D programs now I hand, it back to Tim.
Tim Dyer: Thanks ratio now before I move on to the financials I would like to spend a few moments to speak about the near Hysterics transaction.
Tim Dyer: Due to the excellent progress made by our R&D team in advancing our oncology preclinical portfolio for Pam <unk>.
Tim Dyer: And dropped to negative allosteric modulator programs reached a stage, where they needed significant amount of financing to progressive.
Tim Dyer: Unfortunately, given the low market capitalization biotics raising the amount of capital needed would have been extremely challenging and hi, Alicia for our shareholders. So we decided to spin out these programs.
Tim Dyer: 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 transactions other shareholders as it was so has.
<unk> has secured 5 million Swiss francs, IDEXX and remove the financing overhang on the stock.
Tim Dyer: We have retained a 20% interest in your historic so we can benefit from the upside for us in the programs into the clinic, which is now secured by the $65 million capital from our high quality investors Syndicate led by Central advisors as part of the transaction, we have divested I'll start once that technology platform, including the <unk>.
Tim Dyer: Archie about stock after we have entered into a service agreement with near Thurrock.
Tim Dyer: So that we can access skills needed to execute on our business strategy.
Tim Dyer: Now for a review of the 2020 full financials. Following the near Historic transaction, we were required under IRS to identify continuing operations related to our retained business and discontinued operations related to the divested business salts nearest Eric.
Tim Dyer: 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.
Tim Dyer: Starting with the income statements.
Tim Dyer: Which related to continuing operations.
Tim Dyer: Recognized.
Tim Dyer: 400 thousands of.
Tim Dyer: Other income in 2024 compared to $1 6 million in 2023. The decrease is primarily due to the completion of the funded research phase of our collaboration with <unk> in June of 2024.
Tim Dyer: Continuing R&D expenses of <unk> 9 million remain primarily relate to our Gaba Pam programs decreased by $1 2 million in 2024 compared to 2023, mainly due to the completion of the research space of the engineered collaboration continuing R&D.
Tim Dyer: GSI, continuing G&A expenses of $2 3 million, primarily related to corporate development activities.
Tim Dyer: <unk> decreased by <unk> 4 million.
Tim Dyer: Swiss francs in 2024 compared to 2023, primarily due to the reduced G&A costs.
Tim Dyer: The Finance result law result loss in 'twenty three is turned to a small gain primarily due to a significant reduction in forex exposure.
Tim Dyer: As we are now holding most of our cash in Swiss francs.
Tim Dyer: The share of the net loss of associates.
Tim Dyer: $2 2 million relates to the 20% equity interest received as part of the consideration to the divestment of the part of our business to nearest bearings, which is being accounted for using the equity method under <unk> 12.
Tim Dyer: Under <unk>, we are required to recognize our share of their results.
Tim Dyer: Now to the balance sheet.
Tim Dyer: Our assets are primarily held in cash and we completed 2024 was $3 3 billion Swiss francs of cash held in Swiss francs in U S dollars.
Tim Dyer: Other current assets amounts to <unk> 2 million primarily rate prepaid R&D costs.
Tim Dyer: Our non current assets of $7 1 million.
Tim Dyer: As of December 31, 2024, primarily relate to the 20% equity interest in Aerospace group recorded on the balance sheet under the equity method of accounting for associates current liabilities of <unk> 8 million as of December 31, 2024 decreased by $2 1 million compared to December 31 2023.
Tim Dyer: And primarily relate to R&D related accruals and payables noncore.
Tim Dyer: Non current liabilities.
Tim Dyer: $2 million as of December 31, 2020 sold decreased $5 4 million compared to December 31, 2023, primarily due to the reduction in retirement benefit obligations. Following the transfer of staff to nearest areas.
Tim Dyer: Last the cash flow statement.
Tim Dyer: And the 2020 for the cash balance amounts to $3 3 million and decreased by <unk> 6 million compared to the beginning of the year.
Tim Dyer: The 5 million gross proceeds received as part of the consideration received from.
Tim Dyer: Divestments.
Tim Dyer: Part of our business was offset by the operating costs continuing activities.
Tim Dyer: Now to summarize we have made excellent progress in all gather the Pam program with our partner <unk> selecting compounds in development and substance use disorders, and starting our IND, enabling studies.
Speaker Change: In the second half of 2024 nearest taxes made excellent progress with our lead.
Tim Dyer: Drug candidate starting line DNA studies in Q3 of 2024.
Speaker Change: <unk> is ready to restart clinical development, Brian injury recovery.
Speaker Change: Independent Gaba Pam cough program has demonstrated excellent preclinical efficacy and tolerability with R&D, enabling studies ready to start.
Speaker Change: Yes.
Speaker Change: We're validating partnerships industry for 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.
Speaker Change: Thank you Dear participants as a reminder, if you wish to ask a question over the phone. Please press star one one on your telephone keypad and wait to finance will be announced to withdraw. Your question. Please press star one again, Alternatively, you can submit your questions via the webcast.
Speaker Change: Please somebody will compile the K narrow studies will take a few moments.
Speaker Change: And that will go and take our first question.
Speaker Change: And it comes from the line of Rock Hill ROM Silverado <unk> from H C. Wainwright <unk> co. Your line is open. Please ask your question.
Speaker Change: Excuse me about Graham Thank you Jeff.
Speaker Change: Your line is open for questions.
Speaker Change: Yeah participants once again, if you wish to ask a question. Please press star one one on your telephone keypad and bipolar name to be announced Alternatively, you can submit your questions why the webcast.
Speaker Change: Okay.
Speaker Change: And we have on the line the rock Hill ROM Silverado from HC Wainwright <unk> co. Your line is open. Please ask your question.
Speaker Change: My apologies for Coram, we cannot hear you.
Speaker Change: Dear speakers, we will just give a moment for our participants submit questions and now we'll have another.
Jeff: Jeff give us amendments.
Speaker Change: And the question comes from the line of Peter <unk> from <unk>.
Speaker Change: Consult your line is open please ask your question.
Speaker Change: Good afternoon.
Speaker Change: I would like to know about neuro is very high.
Speaker Change: I think thats, a new company, who they have other projects other than what you now sold to them.
Speaker Change: Thank you Brent answer.
Speaker Change: Did you hear me.
Speaker Change: Yes. Thank you very much for your question.
Speaker Change: Yes.
Speaker Change: Yes, so nearest eric's was actually founded.
Speaker Change: By IDEXX.
Speaker Change: As a spin out company.
Speaker Change: So we packaged up.
Speaker Change: <unk> platform, including <unk>.
Speaker Change: Facilities people.
Speaker Change: And we put it into a new Swiss company, which we then sold to <unk>.
Speaker Change: On a U S LLC.
Speaker Change: Which should be capitalized.
Speaker Change: Capitalized with cash.
Speaker Change: Cash and a capital commitment of $65 million from.
Speaker Change: Our syndicate of U S investors led five perceptual biases.
Speaker Change: And.
Speaker Change: The transaction involved.
Speaker Change: Buying the Swiss subsidiary for a mix of <unk>.
Speaker Change: Cash and equity so Alex received a 20% interest in the U S. L. L C plus $5 million of cash and the rest of the $60 million has been deployed.
Speaker Change: Into the portfolio that was contributed into the nearest derricks with salt.
Speaker Change: And there are whole programs.
Speaker Change: The lead program is our muscarinic <unk> Pam and then there is a.
Speaker Change: And <unk> seven negative modulator program and also and you ought to negative allosteric modulator program and then another program, which is undisclosed at the very early stages of discovery.
Speaker Change: They are all focused on that and neuropsychiatry.
Speaker Change: Schizophrenia mood disorders and cognition.
Speaker Change: And then.
Speaker Change: And an undisclosed CNS indications.
Speaker Change: Does that answer your question.
Speaker Change: But I guess that means do you have a lot of.
Speaker Change: Additional work just to sort.
Speaker Change: Out of control the activities of <unk>.
Speaker Change: And if you're 20% of investment there is that correct.
Speaker Change: While nearest Derek has has its own team.
Speaker Change: And most of the impact.
Speaker Change: Nearest Derek has most of the old Addax team plus new employees have been recruited.
Speaker Change: And.
Speaker Change: Mike.
Mike: I am currently the CEO of nearest derricks and the CEO of IDEXX.
Speaker Change: And Mike.
Speaker Change: My role.
Mike: <unk> is under a service agreement.
Mike: Between <unk> and IDEXX.
Okay that explains it thank you very much Tim.
Tim Dyer: Youre welcome.
Tim Dyer: Thank you.
Tim Dyer: Okay.
Tim Dyer: Now we will proceed with that.
Speaker Change: Question and it comes from the line of Rock Hill ROM Silver Roger from HC Wainwright <unk> co. Your line is open. Please ask your question.
Speaker Change: Thanks for taking my question I wanted to ask if it would be possible for you to enumerate, how youre seeing the strategic environment and essentially evolving for <unk>, particularly within the context of neuro rehabilitation and if you could also comment on the potential ability to deploy.
Speaker Change: <unk> in <unk>.
Speaker Change: <unk> rehabilitation contacts not involving post stroke recovery. Thank you.
Michelle: Michelle would you like to take this question.
Michelle: Yes, absolutely.
Speaker Change: We are.
Michelle: S <unk>.
Michelle: <unk> is a clinical asset that has shown very good tolerability, both in healthy subjects and in.
Michelle: Patients with Parkinson's disease, it gives us an opportunity to.
Michelle: Perform.
Michelle: A number of small clinical pharmacology studies.
Michelle: Aiming to assess improvement and modulation of plasticity in human subjects, who will probably start with healthy volunteers and look at multiple sites or potential causticity from motor cortex twos.
Michelle: Sensory to mid brain to spinal cord also evaluate what type of treatment conditions.
Michelle: Super Bowl and ideal for modulation and then move forward with.
Michelle: Similar study, but performed in post stroke patients. So this will be as we see two clinical pharmacology studies.
Michelle: With specific questions very much focused on neuroplasticity.
Michelle: We believe these studies will.
Michelle: First confirmed the modulation of cluster in humans in particular in post stroke patients that will help us in designing proper phase Iia study.
Michelle: On rehabilitation approach.
Michelle: So that's our view.
Michelle: Three.
Michelle: Overall.
Michelle: Summary of our.
Michelle: Clinical strategy.
Michelle: And then secondly, if I may I was wondering if you could comment on the recent developments in the neuro psych field, perhaps most notably the failure of the phase III trial of <unk> as adjunctive treatment in schizophrenia, and what implications that may have for future direct.
Michelle: <unk> you pursue with one or more of the Neurostar ex lead assets. Thank you.
Michelle: Yes, we saw the news of course, and we believe that it.
Michelle: Has minimal if any impact on our strategy we are pursuing.
Michelle: The strategy of monotherapy.
Michelle: Have we.
Michelle: We believe in the targets, we believe in the relevance of.
Michelle: Muscarinic game for for psychosis, so, it's not going to alter our plans at all.
Speaker Change: And then lastly, Tim I don't know if you are in a position to comment on this at this time, but I was wondering if you could offer us some idea of what if anything you plan to do with the compound that was returned to IDEXX from J&J and if you see any future development path.
Michelle: For that asset thank you.
Michelle: Yes, we are.
Michelle: I mean, we're already discussing with a number of interested parties we are.
Michelle: We are.
Michelle: We're doing our own evaluation.
Michelle: As you can imagine this is a 20 year.
Speaker Change: Development, how does J&J, it's a very very high quality compound.
Michelle: With.
Michelle: A lot of data.
Michelle: A lot of material.
Michelle: About 280 kilograms of API.
Michelle: <unk> has been transferred to us.
Michelle: This set a significant material for us.
Michelle: To play with.
Michelle: We're definitely looking to.
Michelle: Enter a number of collaborations to explore areas that could be pursued with the with the compounds.
Michelle: Thank you very much.
Michelle: Thank you.
Speaker Change: Yeah participants as a reminder, if you wish to ask a question. Please press star one on your telephone keypad. Alternatively, you can submit your questions via the webcast.
Speaker Change: Dear speakers, we will just give me a moment chavez analysts to submit any questions.
Speaker Change: Yes.
Speaker Change: Thank you ladies and gentlemen, this brings the main part of our conference to close and I would like to hand back to Tim <unk> for closing remarks.
Speaker Change: Okay.
Speaker Change: Well. Thank you everyone for attending the 2020 for full year results conference call.
Speaker Change: I wish you all a very nice day, and we look forward to speaking to you again soon.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect have a nice day.
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