Q1 2025 Addex Therapeutics Ltd Earnings Call & Business Update
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Operator: Good day and thank you for standing by.
Speaker Change: Good day and thank you for standing by welcome to the IDEXX Therapeutics first quarter 2025 financial results and corporate update conference call and webcast. At this time all participants are in listen only mode.
Operator: Welcome to the Addex Therapeutics First Quarter 2025 Financial Results and Corporate Update Conference Call and Webcast. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be the question and answer session. To ask a question during the session, you need to press star 1 1 on your telephone keypad. You will now hear an automated message advising your hand is ready. If you wish to ask a question via the webcast, please use the Q&A box available on the webcast link at any time during the conference. Please be advised that this conference is being recorded.
After the speaker's presentation, there will be the question and answer session.
To ask a question during the session you need to press Star one one on the telephone keypad you booked this year.
And the thematic message advancing your hand this waste to withdraw your question. Please press star one again.
If you wish to ask a question via the webcast. Please use Q&A books available on the webcast link at any time during the conference conference must be it.
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Timothy Dyer: I would now like to hand the conference over to our first speaker today, Tim Dyer, CEO. Please go ahead. Hello, everyone.
Speaker Change: I would now like to hand, the conference over to your first speaker today, Tim Dove Seal. Please go ahead.
Okay.
Speaker Change: Hello, everyone.
Timothy Dyer: I'd like to thank you all for attending our Q1 2025 Financial Results Conference call.
Thank you all for attending our Q1 2007.
<unk> financial results conference call I'm here with Macau and Chapel Hill.
Timothy Dyer: I'm here with Mikhail Kalinichev, our Head of Translational Finance, who will provide an update on our R&D programme. I draw your attention to the questions and the financial statements issued earlier today, which are available on our website. I also draw your attention to our disclaimers. We will be making some forward-looking statements that are based on the knowledge we have today.
Thank you.
I'll call your attention.
Speaker Change: Flexibility from the balance sheet.
Issued.
Speaker Change: All right Scott.
Speaker Change: I also draw your attention to slide.
Speaker Change: We will be making certain forward looking statements.
On the mortgage.
Yeah.
Speaker Change: Okay.
Timothy Dyer: 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 start with Coca Cola bottlers with more quickly.
Speaker Change: Recent activity.
Timothy Dyer: I will then hand over to Nisha, who will review in more detail our MDR-5 medevac modulator program for brain injury recovery. and I'll gather the popular state modulations for clinical problems for cough.
All the best.
Speaker Change: Sure.
Speaker Change: Paul.
Speaker Change: <unk>.
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Barbara.
Speaker Change: Okay.
Speaker Change: Okay.
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Paul.
Timothy Dyer: I will then review our Q1 2025 balance results followed and after that we will open the call Q&A. Moving on to the highlights. We have had a great start to the year with several significant value-creating achievements in our pipeline. We've made excellent progress in our GABA-B positive-output modulator program with our partner DIVIOR. We've successfully completed IMD-Enabling studies with their selected blood candidates for substance use disorders. As a reminder, under the terms of the agreement, Addex is eligible for payment of up to $330 million USD on successful achievement of pre-specified regulatory, clinical and commercial markdowns, as well as clear, royal, on the level of net sales from high single digits up to low double digits.
Speaker Change: On the walk Q1.
Speaker Change: With all the smaller box.
Speaker Change: G&A.
Moving on to the highlights.
We have had a great song to the year with several significant value.
John.
Excellent.
Speaker Change: Hopefully that modulates the program.
Speaker Change: GTO.
Speaker Change: Perhaps for the control arm.
Speaker Change: Bobby will get collected.
Speaker Change: Substance use disorders.
Speaker Change: As a reminder, under the terms of the agreement attitude eligible component.
Speaker Change: $330 million.
Speaker Change: To achieve our goals.
Speaker Change: We like to call upon multiple markdown as well.
Speaker Change: Royalties on the level of net sales from high single digits up to low.
Speaker Change: Double digit.
Timothy Dyer: 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: Also under the terms of the agreement we have the right to select compounds in development in a predefined list. The desert in propulsion, we have selected the compounds following independent probably program for the treatment protocol.
Timothy Dyer: We have selected a compound to advance our own independent laboratory PAM programme for the treatment of chronic cough. with substantially completed preclinical profiling of our selected drug candidate and recently published with BASC and 2-CIFS data in multiple preclinical models of CROP.
Speaker Change: We have substantially completed the preclinical profile cobalt for legacy platforms at a recent published.
Speaker Change: Multiple preclinical models all call.
Timothy Dyer: Misha will speak about this exciting data later in our presentation.
Speaker Change: Alicia will speak about this exciting data later, our corporate culture.
Timothy Dyer: We also regained right to our MDL-R2 positive alpha modulator program, including the phase 2 acid ADX71149 from our partner Johnson & Johnson. We are currently evaluating a number of those with good indications for the future development of this program.
Speaker Change: We also regained rights to our <unk> two positive allosteric modulator program, including the phase II asset at AVX.
Speaker Change: My former partner Johnson <unk> Johnson.
Speaker Change: Currently evaluating a number of therapeutic indications for future development at this point.
Timothy Dyer: We have repositioned Dipagluron, our MDR-5 negative L-spec modulated program, for brain injury recovery and recently entered into an option agreement giving us access to an exclusive license to intellectual property covering the use of MDR-5 inhibitors in this interest and therapy application. Misha will talk about this exciting problem later in the presentation.
Speaker Change: We've repositioned our.
Speaker Change: <unk> five negative.
Speaker Change: Magic program brain injury recovery and recently entered into an option agreement with getting impacted full exclusive losses.
Speaker Change: Towards the virtual cockpit, we use that went along with it.
Speaker Change: And it's interesting.
Michelle: Michelle will talk about this important formulation impulsion.
Timothy Dyer: On the financial side, we completed the year with 2.8 million Swiss francs of cash, which provides us with a cash runway through mid-2026.
Speaker Change: On the financial side, we completed the year with $2 8 million in cash.
Speaker Change: Cash deposits for the past 12 months to move towards Homestake's.
Timothy Dyer: I'd like to highlight that the cash burn has been significantly reduced following the New Easteric spin-out transaction, however, the current cash does not fund the progress or the progression of our unpartnered programme in Switzerland.
Speaker Change: Hi.
Speaker Change: James following the U S.
Speaker Change: Transaction.
Speaker Change: Our cash, but not funded by debt.
Speaker Change: Question about Paul.
Speaker Change: Paul.
Speaker Change: Hello.
Timothy Dyer: Now for a quick review of our pipeline. We continue to believe in DIPAGLO and are executing our plans to reposition and develop environmental injury recovery. As mentioned, our partner in goodwill has selected a GABA-B PAM, well-tended for developing substance use disorders and has successfully completed our IND-enabling studies. We are advancing our independent GABA-B program quite fast and expect to start our IND-enabling studies this year subject to spirit and financing. Neosterics has made excellent progress in fastening its pipeline into the starting IND-enabling studies, quite completing IND-enabling studies with its M4 PAM program.
Speaker Change: Now a quick review of our pipeline.
Speaker Change: We continue to believe in <unk>.
Speaker Change: Keeping our plants through traditional development bodily injury recovery.
Speaker Change: And goodwill.
Speaker Change: The GAAP rate.
Speaker Change: But part of it.
Speaker Change: Disorder.
Speaker Change: R&D, enabling studies.
Speaker Change: Bastian.
Speaker Change: Under the program.
Speaker Change: Pulp fiction R&D might be in studies.
Speaker Change: Subjects were financing.
Speaker Change: We've made excellent progress.
Speaker Change: Including <unk>.
Speaker Change: Got it.
Speaker Change: Greetings.
Speaker Change: The studies will be some ballpark background.
Mikhail Kalinichev: Now I will hand over to Dinesh who will give you some more details about our science portfolio.
Michelle: Now I will hand over to Michelle who will give you some more detail.
Michelle: Our defaulted portfolio.
Mikhail Kalinichev: Thanks Tim. Hello everyone. I will start by speaking about Dipagloron and our plans for development in brain injury recovery. Following termination of the development of the program in TBLID, we embarked on a detailed evaluation of a number of potential indications 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 Defenderon makes it particularly suitable for enhancing the impact of rehabilitation in traumatic brain injury and stroke patients. There is a large number, large medical need in post-stroke recovery and rehabilitation.
Michelle: Thanks, Tim.
Michelle: Hello, everyone I will start by speaking about the probably wrong.
Michelle: Our plans for development in brain injury recovery.
Speaker Change: Early termination of the development of the program in PD Lee we embarked on a detailed evaluation of a number of potential indications for keytruda.
Speaker Change: Patricia development.
Speaker Change: We have completed this exercise that have identified brain injury recovery as an interesting indication for the future development.
Michelle: We believe the differentiated profile of <unk> makes it particularly suitable for enhancing the impact of rehabilitation in traumatic brain injury and stroke patients.
Michelle: There is a large number.
Michelle: Large unmet medical need in post stroke recovery.
Michelle: Patient stroke is amount among leading causes of chronic often.
Mikhail Kalinichev: Stroke is among 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 therapy. MGOR5 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.
Michelle: Lifelong disability as it leads to motor sensory cognitive impairment and multiple comorbidities.
Michelle: We're over 100 million stroke survivors worldwide and the number is growing as the annual rate of $12 million.
Michelle: That variety of rehabilitation therapies are used with post stroke patients, but the recovery slow and often inadequate there is an urgent need for pharmacological agent that can facilitate the recovery stimulated by rehabilitation therapy.
Speaker Change: And we're five receptor suitable targets to address post stroke recovery as it is densely expressed of the brain involved in euro plasticity, and modulate sizes or inhibitory accruable impact.
Mikhail Kalinichev: In fact, activation of MGOR5 has been observed in a range of neurological disorders, including post-stroke, where it plays a role in so-called maladaptive rewiring of the brain following stroke. Inhibition of MGOR5, on the other hand, can facilitate adaptive rewiring of the brain, promoting neuroplasticity, and creating of new functional pathways, moving the neural network towards the pre-lesion state. Exciting new evidence recently published in the journal Brain suggests that the negative oxidative modulator of NGLR5, MTEP, administered daily in rats following stroke results in a sustained and growing improvement in sensory motor function in comparison to vehicles. Similar improvement in sensory motor function was observed in animals treated with our NGOA5-NAM deprivation.
Speaker Change: In fact activation of <unk> has been observed in range of neurological disorders, including stroke, where it plays a role in Socal maladaptive rewiring of the brain following stroke inhibition of <unk> on the other hand can facilitate adaptive.
Speaker Change: Wiring of the brain promoting euro plasticity, and creating new functional pathways moving the neural network towards the pre lesion state.
Speaker Change: Exciting new evidence.
Speaker Change: Currently published in the journal brain suggests that the negative allosteric modulator open worldwide impact administered.
Speaker Change: Administered daily rates following stroke result, in a sustained and growing improvement in sensory and motor function in comparison to vehicle treatment.
Speaker Change: Similar improvement in sensory motor function was observed in animals treated with our <unk> five <unk>.
Speaker Change: Yes.
Mikhail Kalinichev: MRI imaging of the resting state functional connectivity in post-stroke rodents shows that daily administration of NTAP also stimulates intra- and inter-hemispheric connectivity in 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 people. The Progleron 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 after. It has shown good tolerability in healthy subjects and in Parkinsonian patients, showing only mild to moderate CNS-related adverse effects.
Speaker Change: MRI imaging of the resting state functional connectivity in post stroke Robins shows the daily administration and pet also stimulate intra and inter emissary connectivity in the great disrupted by stroke.
Speaker Change: It is important to note that.
Speaker Change: Movement in brain connectivity after stroke is known to correlate with functional recovery and as observed across species.
Speaker Change: Okay.
Speaker Change: We probably around is ideally suited to be used in tandem with rehabilitation therapy for stroke patients.
Speaker Change: It has.
Speaker Change: Fast onset of action and short upward.
Speaker Change: It has shown good tolerability in healthy subjects and in Pakistan new patients.
Speaker Change: With only mild to moderate CNS related adverse.
Mikhail Kalinichev: We have a drug product ready and a strong patent position and believe Dipramidone can become a first-in-class drug to facilitate post-stroke recovery. We can also speculate that Dipramidone-mediated adaptive rewiring and facilitation of recovery following brain damage would also be seen in traumatic brain injury patients.
Speaker Change: 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.
Speaker Change: We can also speculate that the primary ruins mediated adaptive rewiring and facilitation of recovery following brain damage with Ulster BC in traumatic brain injury patients.
Mikhail Kalinichev: Let me now switch to our GABA-B Positive Allosteric Modulator program, which is partnered with Indivio. The aim of this collaboration is to deliver a better baclofen for substance use disorders. As a reminder, GABA-B receptor activation has been clinically validated in a number of disease areas using Baclofen and GABA-B ultrasteric agonists. Baclofen is FDA-approved for treatment of spasticity and is widely used or labeled 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.
Speaker Change: Let me now switch to our Gaba positive allosteric modulator program, which is partnered with the video the.
Speaker Change: The aim of this collaboration is to deliver a better back person for substance use disorders.
Speaker Change: Yes.
Speaker Change: As a reminder.
Speaker Change: <unk> B receptor activation has been clinically validated in a number of disease areas using baclofen and cover the <unk> agonist.
Speaker Change: <unk> is an FDA approved for treatment of spasticity and is widely used off label to treat numerous diseases, including substance use disorder.
Speaker Change: However, baclofen has a short half life and comes with significant side effects Humphrey, it's why the year thus.
Speaker Change: Thus.
Mikhail Kalinichev: there is a strong need for a better vaccine. We believe that this can be achieved with positive alzheimer's modulators and the differentiated pharmacology, having the efficacy that is similar or better than that of vaccines, but longer half-life and improved side-effects. Our partner in DVR has selected a GABA-BPAM drug candidate for development in substance use disease. and has started IND-enabling studies in H2 2024.
Speaker Change: There is a strong need for a better box.
Speaker Change: We believe that this can be achieved with positive allosteric modulators and the differentiated pharmacology heading to the efficacy.
Speaker Change: Or better than that of baclofen, but longer half life and improved side effect profile.
Speaker Change: Our partner in DVR has selected a Gaba Pam drug candidate for development in subsequent use disorders and has started IND enabling studies.
Speaker Change: In <unk> 2020.
Mikhail Kalinichev: As part of our agreement with Indiviual, Addex has exercised its right to select a compound to advance its own independent GABA-B-PAM program for the treatment of chronic cough. I will now present this exciting opportunity. There is a strong rationale for developing COVID.
Speaker Change: As part of our agreements with individual IDEXX has exercised its right to select a compound to advance its own independent Gaba Pam program for the treatment of chronic cough.
Speaker Change: I will now present this exciting opportunity.
Speaker Change: There is a strong rationale for developing <unk> for chronic cough.
Mikhail Kalinichev: for Chronic 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 an overactive cough reflex. There is a large unmet medical need in novel antitoxin drugs as current standards of care are ineffective in 30% of patients or only moderately effective in up to 60%. In addition, the current treatments carry risks of serious side effects. On the next slide, we show that GABA-BPAMs are likely to have a superior tolerability profile in comparison to current standards of care and show no taste-related side effects, as seen with a newly approved pitot-3 inhibitor KVAP.
Speaker Change: Coke is a persistent calls that lasts for more than eight weeks and can be caused by a variety of factors, including the states of infections asthma allergies and <unk>, but also possibly by overactive call.
Speaker Change: There is a large unmet medical need no antitoxin drugs as current standards of care are ineffective in 30% of patients.
Speaker Change: Or only moderately effective in up to 60% of patients.
Speaker Change: In addition, the current treatments carry risks of serious side of it.
Speaker Change: On the next slide we show that <unk> are likely to have a superior tolerability profile in comparison to current standards of care and showed no taste related side of it.
Speaker Change: With a newly approved equals three digital okay.
Speaker Change: Okay.
Speaker Change: Okay.
Mikhail Kalinichev: Support for using GABA-B-PAM 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 the anatomical evidence that GABA-B receptors are strongly expressed in airways and in the neural pathway regulating cough. And therefore, we believe that Gavali PAMS could offer superior efficacy in COVID-19.
Speaker Change: We are using <unk> in treatment of chronic call comes from the clinical evidence. The baclofen <unk> agonist is used off label in patients and from the other chemical additives <unk> receptors are strongly expressed and add weight.
Speaker Change: And in the neuro pathway regulations.
Speaker Change: Therefore, we believe that gallery pumps could offer superior efficacy in <unk> eight.
Mikhail Kalinichev: The pre-ING activities, including in vivo proof-of-concept studies, non-GOP talks, and CMC, have been completed. Our clinical candidate has shown favorable efficacy, tolerability, and developability prospects. The compound has demonstrated a consistent minimum effective dose of 1mg and ED50.6.
Speaker Change: The pre IND activities, including in vivo proof of concept studies non GOP talks and CMC has been comfortable.
Speaker Change: Our clinical candidate has shown favorable efficacy tolerability and develop ability profile.
Speaker Change: <unk> has demonstrated a consistent minimum effective dose of <unk> and <unk>.
Mikhail Kalinichev: in models of co-individuals. No signs of tolerance were seen after subclinic dosing and more than 60-fold safety margins were demonstrated based on respiratory depression as sedation biomass.
Speaker Change: In models in vivo.
Speaker Change: Signs of tolerance, we're seeing office upcoming dosing and more than 60 volt safety margin were demonstrated based on respiratory depression and sedation biomarker.
Mikhail Kalinichev: The IIT Medellin studies are planned to start this The next set of slides describes the in vivo proof-of-concept studies and models of COV-19, where we evaluated efficacy and tolerability of our clinical candidate, compound A, and also characterized clinically active antitrustive drugs, nalbufin, bactrosin, codeine, and the P2X3 inhibitor in the same model. In the model of citric acid-induced COV in DNase, acutely administered compound A delivered a robust antitussive efficacy, reducing the COV number dose dependently, and achieving 70% reduction. at the maximum dose. The antigen profile of compound A was similar to that of Narufin, Baklodin, and CODI.
Speaker Change: The IND, enabling studies are planned to start this year.
Speaker Change: The next set of slides describes the in vivo proof of concept studies in models of <unk> well.
Speaker Change: Where we evaluated the efficacy and tolerability of our clinical candidate compound.
Speaker Change: And also characterized clinically active antitussive drugs now portion baclofen coding and the <unk> inhibitor in this same model.
Speaker Change: In the model of citric acid induced call indeed occur.
Speaker Change: Q3 administered compound day delivered a robust antitussive efficacy, reducing the cost number dose dependency and achieving 70% reductions as the maximal dose.
Speaker Change: Answer just the profile of our compound.
Speaker Change: Similar to that of the roofing baclofen and Cody.
Mikhail Kalinichev: Compound A also increases the latency to first call, dose-dependently, thus delaying the onset. the antigenic profile of compound A in delaying COV onset was similar or better. than that of reference drug. in the same experiment. Compound A appeared well-tolerated, as there were no marked changes in respiratory rate at up to 60 mg per kit. In contrast, nalbuffen, vaposan, and codeine resulted in robust reduction of respiratory rate at their highest dose, indicative of sedative-like. when evaluation of the attitudes of efficacy across compounds was done at the respective highest doses free from respiratory compound A was shown to be superior to reference.
Speaker Change: Our compound a also increases the latency to first dose dependent we thus delaying the onset of the antigen profile of compounding delaying called all said with similar or better.
Speaker Change: And that of reference drug.
Speaker Change: In the same.
Speaker Change: Government.
Speaker Change: Impound a appeared well tolerated.
Speaker Change: There were no mark changes in respiratory rate at up to 60 mixed.
Speaker Change: In contrast, now looking backwards and including resulted in robust reduction of respiratory rate.
Speaker Change: Their highest dose indicative of sensitive like effects.
Speaker Change: When the valuation of the antitrust of efficacy across compound was done.
Speaker Change: Respective highs, though this free from respiratory effects.
Speaker Change: Holiday was shown to be superior to reference drugs in both number and coke guidance and measures.
Mikhail Kalinichev: in both COPS number and COPS latency measure. in the chronically administered compound aid showed signs of improved efficacy and potency and no signs of tolerance in comparison to an acute treatment. In the model of ATP-potentiated citric acid COPs in genetics in a head-to-head comparison experiment, acutely administered compound A exhibited a trend of better efficacy and potency in comparison to that of P2X3 inhibitor, while showing signs of similar tolerability.
Speaker Change: In the chronic care administered compound a showed signs of improved efficacy and potency and no signs of tolerance in comparison to Q3.
Speaker Change: And the model of ATP potentiate, the citric acid call ingenuity in a head to head comparison experiment acutely administered compound a exhibited a trend or better efficacy and potency in comparison to that of <unk> inhibitors, while showing signs of similar tolerability.
Mikhail Kalinichev: In summary, we have selected a clinical candidate for chronic colds with a robust reproducible antitustive efficacy. of one week per kid and good PKBD. The compound has the potential to have the best disease efficacy and portability profile and broad application in both patients. The compound showed a favorable developability profile in non-GOP-top studies performed in red-stopped and non-human primers.
Speaker Change: Okay.
Speaker Change: Summary, we have selected our clinical candidate for protocol with a robust reproducible antitussive efficacy.
Speaker Change: One week per key.
Speaker Change: And good PK PD the compound has the potential to have the best in disease efficacy and tolerability profile and growth application in patients.
Speaker Change: The compound show that favorable develop the profile in non GOP Tox studies performed with Red Sox and Nox from a final.
Mikhail Kalinichev: We are on track to start IND-enabling studies this year.
Speaker Change: We're on track to start R&D, enabling studies with.
Timothy Dyer: This concludes our prepared remarks on the progress of our R&D program. Now I hand it back to Tim. Thank you, Nisha.
Speaker Change: This concludes our prepared remarks on the progress of our R&D programs.
Speaker Change: Now I hand, it back to Tim.
Tim: Thank you Felicia.
Timothy Dyer: Now for a view of our Q1 2025 financials. Following the Newestec transaction, we were required under the IFRS to identify continuing operations related to our retained business and discontinued operations related to the divested business of Newestec. All income expense items related to the discontinued operations have been reclassed under a specific line of the comprehensive loss called net loss from discontinued operations. Now, starting with the income statement, which related to the continuing operations, we recognise 0.1 million of income in Q1 2025 compared to 0.2 million in Q1 2024. The decrease is primarily due to the completion of the funded research phase while collaboration with Indigio in June of last year.
Speaker Change: Now for a review of our Q1 2020 financial.
Speaker Change: All of you and your stock transaction, we were required under the encore.
Speaker Change: By continuing operations related to all the payments business in discontinued operations related to the divested business for fall.
Speaker Change: All income and expense items.
Speaker Change: Related to the discontinuing operations lumpy new platform what specific loan.
Speaker Change: Loss net loss from discontinued operations.
Speaker Change: Now starting with the income statement, which related.
Speaker Change: <unk> operations, we recognized.
Speaker Change: $1 million of income in Q1.
Speaker Change: Compared to $2 million in Q1 for the decrease was primarily due to the completion of the funded research collaboration with <unk> with <unk>.
Speaker Change: Jude.
Speaker Change: Last year.
Timothy Dyer: Continuing R&D expenses of £0.1 million primarily related to our WPAM programme and decreased by £0.1 million in Q1 2025 compared to Q1 2024 and again mainly due to the completion of the research phase of our collaboration with Invisio. Continuing GNA expenses of $0.5 million primarily related to corporate development activities and decreased by $0.3 million in Q1 2025 compared to Q1 2024 primarily due to decreased legal fees. Finance results lost in Q1 2025 primarily relates to US dollar currency exchange differences. for sharing that loss of associates. and other professions.
Speaker Change: Continuing R&D expenses of <unk> 1 million, primarily relate to products become program on decreased by 1 million Q1, 2025 compared to Q1.
Speaker Change: <unk> on again, mainly due to the completion that will satisfy our collaboration with Google.
Speaker Change: Continuing on G&A expenses.
Speaker Change: <unk> 5 million primarily related to <unk>.
Speaker Change: Okay.
Speaker Change: $3 million in Q1 compared to Q1.
Speaker Change: Primarily due to decreased legal fees.
Speaker Change: Requirements result loss in Q1, 'twenty five relates to U S dollar currency exchange differences.
Speaker Change: The share of net loss of associates.
Speaker Change: Eight normalized with a 20% equity interest received.
Speaker Change: As part of the consideration for the.
Speaker Change: Our investment although part of our business.
Speaker Change: Which is being accounted for using the equity method under our brands. We are required to recognize our share of their results.
Timothy Dyer: Now to the balance sheet. Our assets are primarily held in cash and we've completed Q1 2025 with 2.8 million Swiss francs of cash held in Swiss francs US dollars. Other current assets amount to $0.4 million, primarily related to pre-paid R&D and G&A costs. Our non-current assets of $6.3 million as of 31st March 2025, primarily related to the 20% equity interest in the Assess Group, recorded on the balance sheet under the Equity Method of Accounting for Associates. Current liabilities of £1.1 million as of March 31, decreased by £0.3 million compared to December 31, 2024, and primarily relates to accrued expenses and payables for the R&D on professional fees.
Speaker Change: Now to the balance sheets, all assets are primarily held in cash and when compared to Q1 2025 to $2 8 million Swiss francs of cash cartons response, we are solid.
Speaker Change: Of the current asset amounts to <unk> 4 million, primarily related to prepaid R&D and G&A costs on.
Speaker Change: Non current asset.
Speaker Change: $6 3 million.
Speaker Change: The March 2025 per barrel related to the 20% equity interest in neuroscience group recorded on the balance sheet under the equity method.
Speaker Change: Sure.
Speaker Change: Current liabilities were $1 1 million as of March 31 decreased $5 2 million compared to the December 31, 2012 bolt.
Speaker Change: On the profitability relates to accrued expenses.
Speaker Change: All of those Guangdong.
Speaker Change: On professional fees.
Timothy Dyer: Non-current liabilities of £0.1 million. and the March 31, 2025 decreased to 0.1 million compared to December 31, 2024 primarily due to the reduction in retirement benefit obligations following changes in the financial function.
Speaker Change: Long term liabilities of $1 1 million.
Speaker Change: Although March 31, 2000 total cost decrease.
Speaker Change: <unk> 1 million compared to December 31 full point.
Speaker Change: Primarily due to a reduction in retirement benefit obligations following changes in the financial functions.
Timothy Dyer: Now to the cash flow statement. On March 31, 2025, the cash balance amounted to $0.8 million, which increased by $0.5 million compared to the beginning of the year, primarily due to the operating costs of continuing operation.
Speaker Change: Now to the cash flow statement on March 31, two composite touchdown month to from a low level.
Speaker Change: $5 million.
Speaker Change: Yes, primarily.
Speaker Change: Due to the operating cost continuing operations.
Speaker Change: Okay.
Timothy Dyer: Now to summarise, we've made excellent progress in our GABA-B program with our partners who are successfully completing R&D enabling studies with their select compounds for development of substance use disorders. Neurosterics have made excellent progress with their lead N4 candidates successfully completing R&D and Aging studies in Q3-Q4. We have strengthened the IP. in our MDR-5 NAMM program, and we're glad you're ready to start. Clinical Development for Brain Injury Recovery. I'll gather the Pam Cox Program has demonstrated excellent preclinical efficacy. and Tolerability with the IBM Edmunds Day Break Start. We are validating partnerships with industry, sports and investors in a strong attitude to put them on a solid position to deliver on our strategic objectives.
Speaker Change: Now I'll summarize we've made excellent progress in our <unk> program.
Speaker Change: With our partners <unk> successfully complete long DNA body, where both select compounds without new substance use disorder.
Speaker Change: We've made excellent progress with our lead handful.
Speaker Change: The partnership successfully completed while in D&A for the machine.
Speaker Change: Paul.
Speaker Change: We have.
Speaker Change: We will strike.
Speaker Change: Pete.
Speaker Change: Our undrawn five non program on the backlog is ready.
Speaker Change: Clinical bar for brain injury recovery.
Speaker Change: Our Gaba B Com Costco Com performance excellence coupon for the portfolio.
Speaker Change: <unk> stops.
Speaker Change: <unk> partnership demonstrates sports are invested in a strong balance sheet as football on a solid position to deliver on our strategic objectives.
Timothy Dyer: This concludes the presentation and we will now open to questions. Thank you.
Speaker Change: Concludes the presentation.
Speaker Change: Two questions.
Operator: Dear participants, as a reminder, if you wish to ask a question, 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.
Richard: Thank you participants as a reminder, if you wish to ask a question. Please press star one on your telephone keypad and like finance will be announced to Richard a question. Please press star one again.
Richard: I'll turn it to be you can submit your questions via the webcast.
Operator: Now we're going to take our first question on the line. And the question comes to land of.
Richard: Now we're going to take the first question on the line.
Richard: Yeah.
Speaker Change: Our next question comes from the line of.
Raghuram Selvaraju: Raghuram Selvaraju from HC Wainwright, your line is open, please ask your question. Hi, thanks very much for taking my questions. I was wondering if you could provide us with your updated thoughts on the current competitive landscape in chronic cough, and in particular, if you could comment on the relevance of preceding programs in terms of guiding what you expect to be the clinical development pathway for your asset in this indication. Yeah, yes, of course. There are a number of uh that are in development currently. One that I can mention in particular is Nalbufin, and that's what's actually the reason we wanted to benchmark it against our compound.
Speaker Change: <unk> <unk> from H C. Wainwright. Your line is open please ask your question.
Speaker Change: Alright, thanks, very much for taking my questions. I was wondering if you could provide us with your updated thoughts on the current competitive landscape in chronic cough and in particular, if you could comment on the relevance of proceeding programs.
Speaker Change: In terms of guiding what do you expect to be in the clinical development pathway for your asset in this syndication fees.
Speaker Change: Yes, Yes of course, there are a number of.
Speaker Change: <unk>.
Speaker Change: Compounds that are in development currently one that I can mention in particular is now bluefin and Thats whats actually the reason.
Speaker Change: We wanted to benchmark it.
Speaker Change: Again, our compounds.
Mikhail Kalinichev: So Nalbufin has shown very promising efficacy profile in patients with IPF-related cause. By the same time, there were clear signs that were indicative of central mediate ventilation. So that tolerability profile will be challenging once you move into the patient population. that has refractory chronic colds that are markedly younger and overall healthy if they're early to mid-50s. instead of early to mid-70s at the IPF. and their level of tolerability is very different so That's where we see a significant opportunity to deliver similar. efficacy with markedly improved tolerability profile and have the compound that can be applied those to IPF-related cough and refractory chronic cough.
Speaker Change: <unk> has shown very promising efficacy profile in patients.
Speaker Change: IPF related costs.
Speaker Change: But at the same time.
Speaker Change: Clear signs that the indicative of central related installation.
Speaker Change: So that tolerability profile will be challenging once you move.
Speaker Change: Two.
Speaker Change: The patient population.
Speaker Change: That helps.
Speaker Change: Refractory chronic cough with our marketing to younger and overall healthy is there early to mid fifties.
Speaker Change: Instead of early to mid seventies.
Speaker Change: Yes.
Speaker Change: And their level of Tolerability before.
Speaker Change: No.
Speaker Change: That's the way we see.
Speaker Change: Mexico opportunity to deliver similar.
Speaker Change: Efficacy is markedly improved tolerability profile and.
Speaker Change: Compound that can be applied those two ips related cost and refractory.
Speaker Change: Corn crop.
Speaker Change: So that's.
Mikhail Kalinichev: That would be my answer to your first part of the question. In terms of our plans for development, we are planning to perform SAD and MAD in healthy volunteers and quickly go and perform a so-called challenge study, which can be done both in healthy controls and in chronical patients. That can be done even at the end of SAD or at the end of MAD as 1B. This offers an opportunity to have a quick and straightforward efficacy readout relatively early in development. This will, of course, follow by a Phase II study in clinical patients. So this will be a refractory clinical patient.
Speaker Change: That would be my answer to your first part of your question in terms of our plans for development. We are planning to perform southern Mad in healthy volunteers and quickly go and perform.
Speaker Change: So called challenge study, which can be done both in healthy controls and in corn quotations.
Speaker Change: That can be done even at the end of SaaS.
Speaker Change: SaaS or at the end of Mad as one <unk>.
Speaker Change: This offers an opportunity to have a quick.
Speaker Change: Straightforward efficacy readouts relatively early in development.
Speaker Change: This will of course follow by a phase two study in chronic <unk> patients.
Speaker Change: So this will be refractory chronic cough patients.
Mikhail Kalinichev: We are also considering to have a more in-depth evaluation of chronic cough in these patients using more advanced technologies that are now being developed and already approved by FDA that allow 24-7 monitoring of cough. That gives an opportunity for much more precise monitoring of cough but also better selection of chronic cough patients. So that will be another innovation on our list.
Speaker Change: We are also considering to have more in depth evaluation of Colombia.
Speaker Change: In this patients using more advanced technologies that are now being developed.
Speaker Change: It will be approved by FDA with a low 24, seven monetary bulk call that.
Speaker Change: Do you see an opportunity for much more precise monitoring of Coke, but also better selection of critical patients.
Speaker Change: So that will be another.
Speaker Change: Innovation on our side.
Mikhail Kalinichev: So that's, that's the answer to your question.
Speaker Change: So that that's down.
Speaker Change: Answer to your question.
Mikhail Kalinichev: So maybe I can just add a little bit to what you just said.
Speaker Change: So maybe I can just add a little bit can you.
Speaker Change: Yes.
Mikhail Kalinichev: Sorry, can you also comment on... Go ahead, go ahead, please.
Speaker Change: Alright can you also comment on go ahead. Please.
Mikhail Kalinichev: Yeah, I just want to add to what Nisha was saying, Raghuram. I think what is so exciting about this program of ours is that, you know, we know that P2X3 inhibitors, which are peripherally restricted, are showing about a 30% reduction in chronic cough. And what was really exciting about the Narbuten data that came out from Trevi, that they were over 50% reduction in cough, in chronic cough patients.
Michel: Just want to add to what Michel was saying.
Speaker Change: So I think what is exciting about this program evolves.
Speaker Change: Now that <unk>, three inhibitors, which our portfolio respective on showing about a 30% reduction.
Speaker Change: Paul.
Speaker Change: What was really exciting about <unk> briefing data that came out from Savi <unk>.
Speaker Change: 50% reduction in and call.
Speaker Change: In chronic cough patients.
Mikhail Kalinichev: And this really supports our hypothesis that you need to have a molecule that's both central and peripheral. And that's what we have with our compound, our GABA-B positive allosteric modulator. What you can clearly see from the data that we've generated preclinically is we have a much better therapeutic margin. So we have reason to believe that we're going to see more than 50%. We'll see a sort of an efficacy readout more similar to Narbuten, but a tolerability profile closer to P2X3 inhibitors, which will give us a very, very clear competitive advantage over not only standard of care today, but what's coming through in the pipeline.
Speaker Change: This really supports our hypothesis that you need to have them a molecule with both central and peripheral.
Speaker Change: That's what we have with our <unk>.
Speaker Change: <unk> talked about that modulate Jeff what you can clearly see from the data that we've generated pre tax rate as we have a much better therapeutic market. So we have reason to believe we're going to see more than 50%, we'll see a sort of an efficacy readouts more similar to what.
Speaker Change: But the Tolerability profile places project, three inhibitors, which will give us a very very clear.
Speaker Change: <unk> competitive advantage.
Speaker Change: The <unk> standard of care today, but what's coming through in the pipeline.
Mikhail Kalinichev: Can you also comment on the potential applicability of this agent to treatment of chronic, painful coughs in indications outside of IPF, particularly pulmonary sarcoidosis? Actually, painful cough could be another indication, in particular, based on the large body of evidence suggesting that GABA-B activation reduces pain across multiple pain conditions, including chronic pain. So this could be absolutely one of the very suitable indications for chronic cough reduction with GABA-B. Yeah, we are thinking about that indication as potentially a path forward in the phase two.
Speaker Change: Can you also comment on the potential applicability of this agent to treatment of chronic painful cough and indications outside of IPF, particularly pulmonary sarcoidosis.
Speaker Change: Okay.
Speaker Change: Actually painful corp could be another.
Speaker Change: Indication.
Speaker Change: In particular based on the.
Speaker Change: Large video evidence, suggesting that Gaba b activation induces pain across multiple pain conditions, including chronic pain.
Speaker Change: <unk>.
Speaker Change: This could be absolutely one of the various superbowl indications for chronic cough.
Speaker Change: Reductions will cover the pump.
Speaker Change: Yes, we are thinking about that indication as potentially a path forward in the phase two.
Speaker Change: Okay.
Mikhail Kalinichev: And then, with respect to Dipraglorant, specifically in the post-stroke rehabilitation context, can you give us a little bit more detail on two aspects? The first would be what an appropriate control arm would look like in a potential registration quality study in this setting, what patients in the control arm would likely be receiving in terms of therapy, whether behavioral or physical or otherwise. And then, secondly, if you could talk a little bit about what the efficacy bar might look like in this indication, given the fact that, as far as I'm aware, there are no pharmacotherapies currently approved in this context.
Speaker Change: And then with respect to different color on specifically in the post stroke rehabilitation context can you give us a little bit more detail on two aspects the first would be what.
Speaker Change: He and I and appropriate.
Speaker Change: Control arm would look like in a potential registration quality study in this setting what patients in the control arm would likely be receiving in terms of.
Speaker Change: Therapy, whether behavior or physical or otherwise and then secondly, if you could talk a little bit about what the efficacy bar might look like in this indication given the fact that as far as I'm aware there are no pharmacotherapy is currently approved.
Speaker Change: In this context.
Mikhail Kalinichev: Yeah, yeah, it's a very good question. The way we see it now, we are planning to use Deterguron in tandem with physiotherapy. because of its short half-life. it can be given multiple times per day and be well tolerated. We are thinking that we need to perform a few studies, including clinical pharmacology studies, to learn more about how department 1 modulates plasticity in both healthy, to start with, and then in patients with stroke. This will really help us in better designing the proper phase 2 study. So this is what we are planning, performing to evaluating measures of plasticity in sensory motor cortex, in the midbrain and spinal cord.
Speaker Change: Yes, it's a very good question the way we see it now we are planning to use the comes around.
Speaker Change: In tandem with CJ therapy.
Speaker Change: Because of its short half life.
Speaker Change: It can be given multiple times per day and be well tolerated.
Speaker Change: We are thinking that we need to perform <unk> studies, including.
Speaker Change: Clinical pharmacology studies to learn more about how the property will modulate equity in both our base to start with and then in.
Speaker Change: Patients with stroke.
Speaker Change: This will really help us in better designing the appropriate phase two study.
Speaker Change: So this is what we are planning.
Speaker Change: Performing to evaluating.
Speaker Change: Measures of plasticity in.
Speaker Change: So the motor cortex.
Speaker Change: In the.
Speaker Change: The brain and spinal cord. We are also interested in exploring whether it's best to keep the compounds before.
Mikhail Kalinichev: We are also interested in exploring whether it's best to give the compounds before the exercise or immediately after. So there are a few components of the design that can be explored in a dedicated clinical pharmacology study before we move forward into a face-to-face.
Speaker Change: The exercise or.
Speaker Change: After so there are few.
Speaker Change: Components of the design that can be explored.
Speaker Change: Dedicated.
Speaker Change: Clinical pharmacologist study before we move forward into a phase II.
Speaker Change: Okay.
Mikhail Kalinichev: Thank you.
Speaker Change: Thank you.
Speaker Change: Thank you.
Operator: Dear participants, as a reminder, if you wish to ask a question, please press star 1 1 on your telephone keypad. Alternatively, you can submit your questions via the webcast. Dear speakers, we'll just give one moment to our participants to submit any questions on the webcast or to press star 11.
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 why the webcast.
Speaker Change: Dear speakers will just give one moment to our participants to submit any questions from the webcast or to press star one.
Speaker Change: Okay.
Speaker Change: Dear speakers there are no further questions for today. Thank you ladies and gentlemen. This brings our main part of the conference toward close and I would like now to hand back to Tim <unk> for any closing remarks.
Timothy Dyer: Thank you ladies and gentlemen, this brings our main part of the conference to a close and I would like now to hand back to Tim Dyer for any closing remarks. Well, thank you very much, everyone, for attending the conference call today, and we look forward to speaking to you again soon. and wish you a very nice day.
Tim: Well. Thank you very much everyone for attending the conference call today, and we look forward to speaking to you again soon.
Speaker Change: Sure Brian.
Operator: This concludes today's conference call. Thank you for participating. You may now disconnect. Have a nice.
Speaker Change: This.
Speaker Change: Today's conference call. Thank you for participating you may now disconnect have a nice day.
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