Good day, and thank you for standing by. Welcome to the Addex Therapeutics Half-Year 2024 Financial Results and Corporate Update Conference Call. At this time, all participants are in listen-only mode. After the speakers' presentation, there will be the question-and-answer session. [Operator Instructions] Dear participants, due to the technical issues today, please use the download button to download the presentation from the download menu and follow it. Thank you so much. And now I would like to hand over the conference to your speaker today, Tim Dyer. Please go ahead.

Hello everyone. I would like to thank you all for standing by and attending our half-year 2024 financial results conference call. I'm here with Misha Kalinichev, our Head of Translational Science, who will be providing an update on our R&D programs. I draw your attention to the press release and the financial statements issued earlier today, which are available on our website. Unfortunately, there has been a technical issue with loading the presentation to the webcast system, so please use the download button in order to download the presentation. We will be indicating slide numbers, so that you will be able to follow, hopefully. So on to slide three, the disclaimer slide. I also draw your attention to our disclaimers. We will be making certain forward-looking statements that are based on the knowledge we have today. I will start this conference call by giving a quick overview of our recent activities and achievements before reviewing our pipeline. I will then hand over to Misha, who will review in more detail some of our clinical and preclinical programs. I will then speak about the recent launch of Neurosterix before reviewing our half-year 2024 financial results. Following that we will open the call for Q&A. So moving to slide four, highlights. We launched Neurosterix with the Series A of $63 million led by Perceptive Advisors. This is an innovative financing transaction that provides us with the resources needed to advance our pre-clinical portfolio without diluting our shareholders' interest in our clinical stage assets and partnered programs. As part of the transaction, we received CHF5 million and a 20% equity interest in Neurosterix, securing the balance sheet and retaining significant upside in the programs for our shareholders. I will speak more about this innovative financing transaction later in the presentation. We have made…

Thanks, Tim. Hello everyone. I will start by speaking about dipraglurant in our plans for development in brain injury recovery. For the termination of the development of dipraglurant in PD-LID, 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. We believe the differentiated profile of dipraglurant makes it particularly suitable for enhancing the impact of rehabilitation in traumatic brain injury and stroke patients. Please move to slide seven. There is a large unmet medical need in post-stroke recovery and rehabilitation. Stroke is among the leading causes of chronic, often lifelong disability as it leads to motor sensory cognitive impairment and multiple comorbidities. There are over 100 million stroke survivors worldwide and the number is growing at the annual rate of 12 million. A variety of rehabilitation therapies are used with post-stroke patients, but the recovery is slow and often inadequate. There is an urgent need for pharmacological agents that can facilitate the recovery stimulated by rehabilitation therapies. Slide eight. mGlu5 receptor is a suitable target to address post-stroke recovery as it is densely expressed in the brain, involving neuroplasticity and modulate excitatory-inhibitory equilibrium. In fact, activation of mGlu5 has been observed in a range of neurological disorders, including stroke, where it plays a role in maladaptive rewiring of the brain following stroke. Inhibition of mGlu5, on the other hand, can facilitate adaptive rewiring of the brain, promoting neuroplasticity, and creating of new functional pathways, moving the neural network towards pre-lesion state. Slide nine. Exciting new evidence recently published in the journal Brain suggests that the negative allosteric modulator of mGlu5, MPEP administered daily in rats following stroke results in a sustained and growing…

Thanks, Misha. So slide 25. Now before I move on to the financials, I would like to spend a few moments to speak about the new Neurosterix transaction. Slide 26, due to the excellent progress made by our R&D team in advancing our own partners pre-clinical portfolio, our M4PAM, mGlu7 NAM, and mGlu2 NAM programs reached a stage of development where they needed significant amounts of financing to progress into the clinic. Unfortunately, given the low market capitalization of Addex, raising the amounts of capital needed would have been extremely challenging and highly diluted to our shareholders. So we decided to spin out these programs and our platform into a new private company and raise the necessary capital directly into a new private company. We believe this is an excellent transaction for Addex shareholders as it has secured $5 million for Addex and removed the financing overhang on the Addex stock. We have retained a 20% interest in Neurosterix, so we can benefit from the upside from advancing the programs into the clinic, which is now secured by $63 million of capital from a high-quality investor syndicate led by perceptive advisors. As part of the transaction, we have divested our allosteric modulation technology platform, including the majority of our staff. However, we have entered into a service agreement with Neurosterix to ensure that we can access the skills needed to execute on our business strategy. Now, moving on to slide 27, financials. Now for review of our half-year and Q2 2024 financials. Following the Neurosterix transaction, we were required under IFRS to identify continuing operations related to our retained business and discontinued operations related to the divest business source Neurosterix. All income and expense items related to the discontinuing operations have been reclassed under a specific line of the comprehensive…

Thank you, dear participants. [Operator Instructions] And now we're going to take our first question and it comes from Lan of Raghuram Selvaraju from H.C. Wainwright & Co. Your line is open. Please ask your question.

Thanks very much for taking my questions and congratulations on all the progress on so many fronts. Firstly, I wanted to ask if you have some sense of the specific clinical indications in which you expect the chronic cough program to proceed with highest probability? Clearly, chronic cough is a serious symptomatic hallmark of many different respiratory, pulmonary, and inflammatory diseases, but I wanted to know which ones you consider to be particularly attractive? And what we might expect to be the clinical path forward? For example, would you be considering advancement in COPD or sarcoidosis or related indications, please?

We haven't finalized the clinical patient population to aim at. Currently we are considering refractory and unexplained chronic cough as one possibility, but we are open to the ideas of also aiming at COPD or IPF-related chronic cough. So this is still being discussed.

Also, just from a clarificatory standpoint, I wanted to know whether you use the terms MED and ED50 interchangeably or not?

Oh no, no, MED is minimum effective dose and ED50 is effective dose, is a dose that reaches 50% of the effect.

The confusion stems from the fact that sometimes they use the MED abbreviation to mean median effective dose, which is the same as ED50. But if you use it as minimum effective dosing, that explains how you are using those terms. Also, I wanted to see if you had any commentary regarding what you expect to be the most appropriate comparator or competitor molecules that have historically been tested clinically in chronic cough that you would look to be the benchmark for your chronic cough program, you know, in the clinical context?

We can consider baclofen and the other [GABAB PAM] (ph) those two have been tested in the clinic, their clinical studies, and they are agonist, so would like to achieve similar, if not better, efficacy with improved tolerability. So that will be our aim.

But not Camlipixant. Is that correct?

Well, I think clearly, we're expecting Camlipixant be standard-of-care by the time we get to later-stage development. So we will be definitely looking and to compare our compound with Camlipixant absolutely.

And we aim to achieve efficacy in a broader population of patients. As you know, up to 25% of patients do not respond to Camlipixant and we'll be aiming to have a higher percentage of responders based on the mechanism that we are using.

Yes. And I think probably many of the folks listening today will remember last year's transaction in which the developer of Camlipixant was acquired for $2 billion. So clearly, if you show broader efficacy than Camlipixant, that's potentially a very high-value program. Just wanted to ask also about some recent developments in the neurology neuropsychiatry space that may have applicability to the prospects of the Neurosterix spin-out. In particular, the label that was granted to Cobenzie, formerly known as CARXT, which was developed by Corona Therapeutics and which subsequently was acquired by Bristol. So I was wondering if there are any takeaways you got from looking at the label for Cobenzie that may provide more of an opportunity within the schizophrenia context, particularly with regard to the prospects for the M4 positive allosteric modulator?

Well, we haven't yet had a chance to have a good look through the label -- but what we do know is that it's quite a broad label, and therefore, this bodes very well for other M4 compounds that are going to come up for regulatory approval.

And in that context, you -- I believe, have also previously indicated that the pharmacophore question that you folks are working on with regard to M4 modulation is distinct from the emraclidine pharmacophore, is it not?

Yes, correct. It's a novel chemistry completely different from any described M4 chemistry that's out there, whether it's the emraclidine program or any of the other M4 PAM programs without our chemistry is different, yes.

Can you just refresh my memory with respect to when you anticipate the first of the Neurosterix portfolio compounds to potentially complete IND-enabling studies?

Yes. So we're on track to complete the IND-enabling studies in the middle of next year and rapidly file the IND, so that we can move into Phase 1 at the -- in the second-half of 2025.

Not sure if you're in a position to speculate at this juncture regarding the prospects for a public listing of Neurosterix itself?

I am certainly not at liberty to talk about the strategy of Neurosterix on this conference call. I'm afraid.

Thank you very much for taking my questions. Appreciate it.

Thanks, Raghuram.

Thank you. [Operator Instructions] Thank you, ladies and gentlemen. This brings the main part of our conference to a close. And I would now like to hand back to Tim Dyer for closing remarks.

So thank you, everyone, for attending our half year 2024 conference call, and we look forward to speaking to you again soon.

That does conclude our conference for today. Thank you for participating. You may now all disconnect. Have a nice day.