Addex Therapeutics Ltd

Dear ladies and gentlemen, welcome to the DEX conference of Edex Therapeutics regarding the announcement of the full year 2020 financial results. At our customer's request, this conference will be recorded. As a reminder, all participants will be in a listen-only mode. After the presentation, there will be an opportunity to ask questions. If any participant has difficulties hearing the conference, please press star key followed by zero on your telephone for operator assistance. and now I hand you over to Tim Dyer who will lead you through this conference. Please go ahead.

Hello everyone. I would like to thank you all for joining our 2020 Full Year Financial Results webcast. I am here with Roger Mills, our Chief Medical Officer, and Robert Lugins, our Head of Discovery Biology. I draw your attention to the disclaimer. We will be making certain forward-looking statements which are based on the knowledge we have today. I will start by giving a quick overview of the company and reviewing our 2020 financial results. I will then hand over to Roger and Robert who will provide an update on our clinical and preclinical programs. Despite the global pandemic, we have made solid progress in 2020 and now have three clinical stage programs which are all scheduled to start clinical studies in the first half of this year. The company was founded based on a leading drug discovery technology platform which is focused on allosteric modulator drug discovery. It is this platform which has generated the deep pipeline of in-house discovered programs focused on unmet medical needs in urology. We have active partnerships with Indivior and Johnson & Johnson, which were entered into at the discovery phase and provide significant validation of our technology platform. These partnerships are providing significant funding for our GABA-B-PAM and epilepsy programs. Under these agreements, we are eligible for more than 400 million in success-based milestones in addition to royalties. We're a Swiss company founded in 2002 with operations in Geneva and San Francisco. We're listed on the Swiss Stock Exchange since 2007 and in January last year we successfully listed an American depository share representing six ordinary shares on the NASDAQ capital market. And in January this year we completed our first offering of new shares in the form of ADSs on the NASDAQ and raised $11.5 million in gross proceeds. Now to our pipeline. As mentioned, our pipeline has been discovered in-house from our discovery platform and comprises nine small molecule out-of-state modulator programs, all focused on neurological disorders. In addition to our LEAD program for PD-LID, we are developing a long-acting formulation of Diproglont for dystonia and expect to start a Phase II study in blepharospasm patients using the immediate release formulation in the coming months. Our partner Janssen is on track to start a Phase 2 POC study in epilepsy with dosing of patients expected in the second quarter of this year. We have made solid progress in our GABA-B-PAM programme and expect to deliver clinical candidates by the end of 2021 for both Indivio and for our independent CMT1A programme. Our mGluR7-NAM and mGluR2-NAM programmes have also made significant progress and are advancing towards clinical candidate selection phase. I remind you that the MGLA7 NAMM program for PTSD is funded by a Eurostars inner Swiss grant of €4.85 million. Now to the key activities that have driven our 2020 financial results. In January last year, we completed one of our long-term objectives, which was the listing of American depository receipts on the NASDAQ capital markets, and this January we completed a small capital increase of 11.5 million through the issue of shares in the form of ADSs. Despite the constraints imposed by COVID-19 situation, we have continued to advance our PD-LID registration program with the completion of several non-clinical activities. We also made good progress in our dystonia program with the preparation of a Phase 2 study with diprachloron for blepharospasm. Our partner Janssen took the decision to advance ADX 71149 into a phase 2 epilepsy study which is expected to start dosing patients in the coming months. We recognized 3.6 million Swiss francs of revenue in 2020 under our funded research partnership with Indivio and in October extended the research term with 2.8 million dollars of additional research funding. We have continued to invest in our early stage pipeline and advanced our mGluR2-Nam and mGluR7-Nam programs into late lead optimization during 2020. InnoSwiss awarded us and our academic partner SIB a 600,000 grant to deploy a computational approach to identify novel therapeutic areas for ADX161, a highly selective D1 antagonist. ADX161 is a clinical stage assay which we deprioritized in 2008. Depending on the outcome of the SIB collaboration, we may consider restarting this program. Now I would like to briefly review our financial results. Now on to the income statement, we recognize 3.6 million of revenue from Indivio in 2020 compared to 2.8 million in 2019. Revenue is recognized based on the costs incurred and the increase in 2020 is primarily due to the progress of the program to more expensive activities as molecules advance towards clinical candidates. We also recognize 266,000 of revenue under our Eurostainer Swiss grant, which is partially funded out of EMGLU-R7-NAM PTSD program. R&D expenses of 10.4 million are primarily related to Dipraglont PD-LID and blepharospasm programs, and to a lesser extent, our GABA-B-PAM program for addiction and Charcot-Marie-Tooth 1A neuropathy. The reduction in R&D expense is primarily due to us suspending certain clinical activities due to the global pandemic. G&A expenses have increased significantly in 2020, mainly due to costs associated with the listing of American depository shares on the NASDAQ and certain other costs associated with operating as a U.S. listed company. The financial result is an expense primarily due to Lénaic Teyssédou On the liabilities side of the balance sheet, the main item is payables and accruals related to clinical and preclinical research organisations. These amounts decreased significantly in 2020 due to the lower clinical related supplier payables at the year end. Contract liabilities and deferred income relates to amounts received from Indivior and Eurostar Inner Swiss which have not yet been recognised as income. Now to the cash flow statement. We started the year with 31.5 million, consumed 15.4 million in our operations and received 3.1 million in research funding from Indivior. We have a paper loss of 0.6 million in forex when US dollar cash balances are converted to Swiss francs for the end of the year financial reporting purposes, resulting in 18.7 million at the end of the year. I will now hand over to Roger who will provide an update on our clinical programs.

Thank you, Tim. Good afternoon to those of you in Europe and good morning to those in the United States. Together with Robert, I would like to give an update on our different clinical programs for Parkinson's disease, levodopa-induced dyskinesia, or PD-LID, and blepharospasm, as well as an introduction to the epilepsy program being started by our partner, Janssen. The development of LID in PD represents a therapeutic challenge for both patients and their doctors. This is a large underserved market in need of improved treatment options and represents a significant commercial opportunity with limited competition. Dipreglorant has an ideal PK profile to treat LID and the program is supported by strong preclinical data together with our previous Phase 2 proof-of-concept study. And it is underpinned by a mechanism of action. And I'll pass you to Robert to give you more detail.