Addex Therapeutics Q1 2025 Earnings Report

Addex Therapeutics EPS Results

• Actual EPS: N/A
• Consensus EPS: -$1.42
• Beat/Miss: N/A
• One Year Ago EPS: N/A

Addex Therapeutics Revenue Results

• Actual Revenue: N/A
• Expected Revenue: N/A
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Addex Therapeutics Announcement Details

• Quarter: Q1 2025
• Date: 6/20/2025
• Time: Before Market Opens
• Conference Call Date: Thursday, June 19, 2025
• Conference Call Time: 10:00AM ET

Addex Therapeutics (NASDAQ:ADXN) Ltd discovers, develops, and commercializes small-molecule pharmaceutical products for central nervous system (CNS) disorders in Switzerland. The company focuses on the discovery of G-protein coupled receptors and enzymes. Its lead programs include Dipraglurant for the treatment of Parkinson's disease levodopa-induced dyskinesia and dystonia, and post-stroke/TBI recovery; ADX71149, a novel orally active metabotropic glutamate receptor subtype 2 positive allosteric modulator (mGlu2 PAM) for the treatment of epilepsy; and GABAB PAM for the treatment of pain, anxiety, overactive bladder, and addiction, as well as substance use disorder. Addex Therapeutics Ltd has license and collaboration agreement with Janssen Pharmaceuticals Inc. for the discovery, development, and commercialization of novel mGlu2 PAM compounds for the treatment of CNS and related diseases; license and research agreement with Indivior PLC discovery, development, and commercialization of novel GABAB PAM compounds for the treatment of addiction and other CNS diseases; and The CharcotMarieTooth Association to evaluate the role of GABAB PAM compounds in preclinical models of CMT1A. The company was formerly known as Addex Pharmaceuticals Ltd. Addex Therapeutics Ltd was founded in 2002 and is based in Geneva, Switzerland.

Addex Therapeutics Q1 2025 Earnings Call Transcript

Key Takeaways

• Adex’s partner Indivior successfully completed IND enabling studies for a GABAB PAM candidate in substance use disorders, unlocking up to $330 million in milestone payments plus tiered royalties.
• The company selected and profiled its own GABAB PAM drug candidate for chronic cough, demonstrating robust preclinical efficacy and tolerability, with IND enabling studies planned this year.
• Adex regained rights to an mGluR2 PAM program (ABX-711149) from Johnson & Johnson and is evaluating multiple therapeutic indications for future development.
• Dipragluron, an mGluR5 NAM for brain injury recovery, has been repositioned with a strong patent estate, a drug product ready, and evidence of promoting neuroplasticity in stroke models.
• The company ended Q1 with CHF 2.8 million in cash, extending its runway to mid-2026 but lacks sufficient funding to advance its unpartnered programs into the clinic without additional financing.

Presentation

[Operator]

Good day, and thank you for standing by. Welcome to the Adex Therapeutics First Quarter twenty twenty five Financial Results and Corporate Update Conference Call and Webcast. At this time, all participants are in listen only mode. After the speakers' presentation, there will be the question and answer session. To ask a question during the session, you need to press star one one on your telephone keypad.

[Operator]

You will not hear an automated message advising your hand is raised. Please be advised that this conference is being recorded. I would now like to hand the conference over to our first speaker today, Tim Dyer, CEO. Please go ahead.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Hello, everyone. I'd like to thank you all for attending our Q1 twenty twenty five financial results conference call. I'm here with Mikhail Belinchev, our Head of Translation Science, who will provide an update on our R and D program. I draw your attention to the press release and the financial statements issued earlier today, which are available on our website. I also draw your attention to our disclaimers.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

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 activity and achievements before reviewing our pipeline. I will then hand over to Misha who will review in more detail our MUR five metabolic modulator program for brain injury recovery, and I'll gather the popular effect modulation for clinical programs for cough. I will then review our Q1 twenty twenty five financial results. Following that, we will open the call for Q and A.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

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 alpha modulator program with our partner Didior. Who successfully completed IND enabling studies with their selected drug candidate for substance use disorders. As a reminder, under the terms of the agreement, Alex is eligible for payment of up to $330,000,000 US dollars and successful achievement of pre specified regulated clinical and commercial milestones as well as tiered royalties on the level of net sales from high single digits up to low double digits.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Also under the terms of the agreement, we have the right to select compounds for development in a predefined list of reserved indications. We have selected a compound to advance our own independent Fabry PAM program for the treatment of chronic cough. We have substantially completed preclinical profiling of our selected drug candidate and recently published robust antiducid data in multiple preclinical models of cough. Misha will speak about this exciting data later in our presentation. We also regained rights to our mGluR2 positive alpha modulator program, including the phase two asset ABX-seven eleven49 from our partner Johnson and Johnson.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

We're currently evaluating a number of therapeutic indications for the future development of this program. We've repositioned vipocalor on our mGAR5 negative air spread modulator 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 mGrA5 inhibitors in this interest and therapy indication. Micha will talk about this exciting program later in the presentation. On the financial side, we completed the year with CHF 2,800,000.0 cash, which provides us with a cash runway through mid-twenty twenty six. I'd like to highlight that the cash burn has been significantly reduced following the Eurosteric spin out transaction.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

However, current cash does not fund the progress or the progression of our partnered unpartnered program into clinic. Now for a quick review of our pipeline. We continue to believe in dipagrel and are executing our plan through repositioning development in brain injury recovery. As mentioned, our partner, Didiol, has selected a Galvan B pan substandard development in substance use disorders and have successfully completed IND enabling studies. We're advancing our independent GAVA B program, chronic cough, and expect to start IND enabling studies this year, subject to strain financing.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Neuroserics has made excellent progress in advancing its pipeline, including starting IND enabling studies sorry, completing IND enabling studies with the ten four PAM program. Now I will hand over to Nisha, who will give you some more details about our exciting portfolio.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

Thanks, Tim. Hello, everyone. I will start by speaking about and our plans for development in brain injury recovery.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

For the termination of the development of the turnaround in PD LID, we embarked on the detailed evaluation of a number of potential indications of interest for future development. We have completed this exercise and have identified brain injury recovery as an interesting indication for the future development. We believe the differentiated profile of diparagirond makes it particularly suitable for enhancing the impact of rehabilitation in traumatic brain injury and stroke patients. There is a large unmet medical need in post stroke recovery and rehabilitation. Stroke is among leading causes of chronic, often lifelong disability, as it leads to motor sensory cognitive impairment, and multiple comorbidities.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

There are over one hundred million stroke survivors worldwide, and the number is growing at the annual rate of twelve 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. In fact, activation of MWR5 has been observed in a range of neurological disorders, including stroke, where it plays a role in so called maladaptive rewiring of the brain following stroke.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

Inhibition of MWR5, 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. Excited new evidence recently published in the journal Brain suggests that the negative allosteric modulator of mGluR5 mPET administered daily in red following stroke results in a sustained and growing improvement in sensory motor function in comparison to V Go treatment. Similar improvement in sensory motor function was observed in animals treated with our Mgwaf5NaM dupaglutide. MRI imaging of the resting state functional connectivity in post stroke rodents shows that daily administration of MTEP 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 species.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

Upgrabularon is ideally suited to be used in tandem with rehabilitation therapies in post stroke patients, as it has a fast onset of action and short half life. It has shown good tolerability in healthy subjects and in Parkinsonian patients, showing only mild to moderate CNS related adverse effects. We have a drug product ready, and a strong patent position, and believe dipramilant can become a first in class drug to facilitate for stroke recovery. We can also speculate that dupamilion mediated adaptive rewiring and facilitation of recovery following brain damage would also be seen in traumatic brain injury patients. Let me now switch to our GABA B positive allosteric modulator program, which is partnered with Invidio.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

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, a GABA B autosteric agonist. Baclofen is FDA approved for treatment of spasticity, and is widely used off label to treat numerous diseases, including substance use disorder. However, baclofen has a short half life, and comes with significant side effects, hampering its widely used. Thus, there is a strong need for a better buccoaffin.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

We believe that this can be achieved with positive auxiliary modulators and their differentiated pharmacology, having the efficacy that is similar or better than that of makvotin, but longer half life and improved side effect profile. Our partner, Indivior, has selected a gabapam drug candidate for development in substance use disorders, and has started IND enabling studies in H2 twenty twenty four. As part of our agreement with Indivior, ADX has exercised its right to select a compound to advance its own independent gammaB PAM program for the treatment of chronic cough. I will now present this exciting opportunity. There is a strong rationale for developing GABA B PAMs for chronic cough.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

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 antitussin drugs, as current standards of care are ineffective in thirty percent of patients, or only moderately effective in up to sixty percent of patients. In addition, the current treatments carry risks of serious side effects. On the next slide, we show that gabapam 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 pitotin inhibitor, gefapixat. Support for using GABA B PAMs in treatment of chronic cough comes from the clinical evidence that baclofen, a GalB agonist, is used off label in cold patients, and from the anatomical evidence that GalB receptors are strongly expressed in airways and in the neural pathway regulating cough.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

Therefore, we believe that galovipam could offer superior efficacy in cold patients. The pre IND activities, including in vivo proof of concept studies, non GLP tox, and CMC, have been completed. Our clinical candidate has shown favorable efficacy, tolerability, and developability profile. The compound has demonstrated a consistent minimum effective dose of one mGg and ED50 of six mGg in models of COC in vivo. No signs of tolerance were seen after sub chronic dosing, and more than 60 fold safety margins were demonstrated based on respiratory depression as sedation biomarker.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

The IND enabling studies are planned to start this year. The next set of slides describe the in vivo proof of concept study in models of coking vignette bits, where we evaluated efficacy and tolerability of our clinical candidate, Compound A, and also characterized clinically active antitussive drugs, nalbuphine, factofen, codeine, and the p2x3 inhibitor in the same model. In the model of citric acid induced cough in dedupec, acutely administered compound A delivered a robust antitussive efficacy, reducing the cough number dose dependently, and achieving 70% reductions at the maximum dose. The anti tumor profile of compound A was similar to that of Nalbuphine, baclofen, and codeine. Compound A also increased the latency to first off dose dependently, thus delaying the onset of cough.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

The antigenic profile of compound A delaying cough onset was similar or better than that of reference drugs. In the same experiment, compound a appeared well tolerated as there were no marked changes in respiratory rate at up to sixty mgs per kg. In contrast, Nalbuphine, baclofen, and codeine resulted in robust reduction of respiratory rate at their highest dose indicative of sedative like effects. When evaluation of the antiducid efficacy across compounds was done at the respective highest doses free from respiratory effects, compound A was shown to be superior to reference drugs in both cough number and cough latency measures. In the chronically administered compound A showed signs of improved efficacy and potency, and no signs of tolerance in comparison to an acute treatment.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

In the model of ATP potentiated citric acid cough 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. In summary, we have selected a clinical candidate for chronic cough with a robust, reproducible antitussive efficacy of one mg per kg and good PKPD. The compound has the potential to have the best disease efficacy and tolerability profile, and broad application in co patients. The compound showed a favorable developability profile in non GLP tox studies performed in red cells and non tumor primates.

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

We are on track to start IND enabling studies this year. This concludes our prepared remarks on the progress of our IND program. Now I hand it back to Tim.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Thanks, Misha. Now for a review of our Q1 twenty twenty five financials.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Following the NewRestar transaction, we were required under the IFRS to identify continuing operations related to our retained business and discontinued operations related to the divested business sold to NSF. All income and expense items related to the discontinued operations have been reclined under a specific line of the compound loss called net loss from discontinued operations. Now starting with the income statement, which related to the continuing operations, we recognized $100,000 of income in Q1 twenty twenty five compared to $200,000 in Q1 twenty twenty four. The decrease is primarily due to the completion of the funded research phase of our collaboration with Indivior in June of last year. Continuing R and D expenses of $100,000 primarily related to our gabapentin program and decreased by $100,000 in Q1 twenty twenty five compared to Q1 twenty twenty four and, again, mainly due to the completion of the research phase of our collaboration with Indivior.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Continuing G and A expenses of $500,000 primarily related to corporate development activities and decreased by $300,000 in Q1 twenty twenty five compared to Q1 twenty twenty four, primarily due to decreased legal fees. The finance results loss in Q1 twenty five finally relates to U. S. Dollar currency exchange differences. The share of net loss of associates of 800,000.0 relates to the 20% equity interest received as part of the consideration for the divestment of a part of our business to Neurosperic, which is being accounted for using the equity method.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Under IFRS, we are required to recognize our share of their results. Now to the balance sheet. Our assets are primarily held in cash, and we completed Q1 of twenty twenty five with CHF 2,800,000.0 of cash held in U. S. Other current assets amounts to $400,000 primarily related to prepaid R and D and G and A costs.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Our noncurrent assets of $6,300,000 as of 03/31/2025, primarily related to the 20% equity interest in Eurostex Group recorded on the balance sheet under the equity method of accounting for associates. Current liabilities of $1,100,000 as of March 31 decreased by $300,000 compared to 12/31/2024, and it primarily relates to accrued expenses and payables beyond the R and and professional fees. Noncurrent liabilities of 100,000.0 as of 03/31/2025 decreased to 100,000.0 compared to 12/31/2024, primarily due to the reduction in retirement benefit obligations following changes in the financial assumptions. Now to the cash flow statement. On 03/31/2025, the cash balance amounted to EUR $08,000,000 and decreased EUR 500,000.0 compared to the beginning of the year, primarily due to the operating cost of continuing operations.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Now to summarize, we've made excellent progress in our GABA B program with our partner in Gilead successfully completing IND enabling studies with their select compound development of substance use disorders. Neuroserics has made excellent progress with their lead N4 PAM, but candidate successfully completing our IND enabling study in q three twenty four. We have we have strengthened the IP in our MGR five program, and Dipaglide is ready to start clinical development for brain injury recovery. Our GammaB pan tox program has demonstrated excellent preclinical efficacy and tolerability behind the stage rate starts. We are validating partnerships, industry, sports and investors, a strong balance sheet, which puts us on a solid position to deliver on our strategic objectives.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

This concludes the presentation, and we will now open the call for questions.

[Operator]

Thank you. Alternatively, you can submit your questions via the webcast. Now we're going to take the first question on the line. And the question comes from the line of Raghuram Selvaraju from H. C. Wainwright. Your line is open. Please ask your question.

[Raghuram Selvaraju, MD - Healthcare Equity Research at H.C. Wainwright & Co., LLC]

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 proceeding programs in terms of guiding what you expect to be the clinical development pathway for your asset in this indication?

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Yeah. Yes. Of course. There are a number of, compounds that are in development currently. One that I can mention in particular is nalbufin, and that was actually the reason we wanted to benchmark it against our compound.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

So nalbufin has shown very promising efficacy profile in patients with IPF related cough. By the same time, there were clear signs that were indicative of central immediate inflammation. So that tolerability profile will be challenging once you move into the patient population that has refractory chronic coughs that are markedly younger and overall healthy in their early to mid fifties, instead of early to mid seventies as in IPF, and their level of tolerability is very different. So that's where we see significant opportunity to deliver similar efficacy with markedly improved tolerability profile and have the compound that can be applied both to IPF related cough and refractory chronic cough. So that's that's would be my answer to your first part of the question.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

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 chronic co 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 readouts relatively early in development. This will, of course, follow by a phase two study in chronic cough patients. So this will be a refractory chronic cough patient.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

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 20 fourseven monitoring of cough that gives an opportunity for much more precise monitoring of COB, but also better selection of chronicle patients. So that will be another innovation on our side. So that's the answer to your question. So maybe I can just add a little bit to what we can do. Yes.

[Raghuram Selvaraju, MD - Healthcare Equity Research at H.C. Wainwright & Co., LLC]

Sorry. Can you also comment on go ahead. Go ahead, please.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Yeah. I just want to add to what Misha was saying, Graham. So I think what is so exciting about this program, Avars, is that we know that P2X3 inhibitors, which are fully and are showing about a 30% reduction in chronic cough.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

And what was really exciting about the nalbuphine data that came out from Trevy is that there were over fifty percent reduction in cough, chronic cough patients. And this really supports our hypothesis that you need to have a molecule with both central and peripheral, and that's what we have with our compound AI, our GABAB, called the valsartan modulator. What you can clearly see from the data that we generated preclinically is we have a much better therapeutic margin. So we have reason to believe that we're going to see more than fifty percent. We'll see a sort of an efficacy readout more similar to nalbutrin, 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.

[Raghuram Selvaraju, MD - Healthcare Equity Research at H.C. Wainwright & Co., LLC]

Can you also comment on the potential applicability of this agent to treatment of chronic painful cough in indications outside of IPF, particularly pulmonary sarcoidosis?

[Mikhail Kalinichev, Head of Translational Science at Addex Therapeutics]

Actually, painful cough could be another indication in particular based on the large volume 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 PAM.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Yeah. We are thinking about that indication as potentially a path forward in the phase two.

[Raghuram Selvaraju, MD - Healthcare Equity Research at H.C. Wainwright & Co., LLC]

And then with respect to depaglarant, specifically in the post stroke rehabilitation context, Can you give us a little bit more detail on two aspects? The first would be what a an 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 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.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Yeah. Yeah. It's a very good question. The way we see it now, we are planning to use dicagrelorant in tandem with physiotherapy. Because of its short half life, it can be given multiple times per day and be well tolerated.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

We are thinking that we need to perform few studies, including clinical pharmacology studies, to learn more about the DPR1 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 two study. So this is what we are planning, performing, evaluating measures of plasticity in sensorimotor cortex, in the midbrain and spinal cord. 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 oncology study before we move forward into a phase two.

[Raghuram Selvaraju, MD - Healthcare Equity Research at H.C. Wainwright & Co., LLC]

Thank you.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Thank

[Operator]

you. Dear speakers, we'll just give one moment to our participants to submit any questions on the webcast or to press 11. Dear speakers, there are no further questions for today. Thank you, ladies and gentlemen. This brings our main part of the conference to a close.

[Operator]

And I would like now to hand back to Tim Dyer for any closing remarks.

[Tim Dyer, Co-Founder, CEO & Board of Director at Addex Therapeutics]

Well, thank you very much, everyone, for attending conference call today, and we look forward to speaking to you again soon. I wish you a very nice day.

[Operator]

This concludes today's conference call. Thank you for participating. You may now disconnect. Have a nice day.

Participants

Executives

• Tim Dyer, Co-Founder, CEO & Board of Director
• Mikhail Kalinichev, Head of Translational Science

Analysts

• Raghuram Selvaraju, MD - Healthcare Equity Research at H.C. Wainwright & Co., LLC