Addex Therapeutics Ltd

Good day and thank you for standing by. Welcome to the ADEX Therapeutics to announce full year 2022 financial results and provides corporate update conference call. 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 then hear an automated message advising your hand is raised. To withdraw your question please press star 1 1 again. To ask a question via the webcast, please access the Ask a Question tab. 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. Please go ahead.

Hello, everyone. I'd like to thank you all for attending 2022 Full-Year Financial Results Conference Call. I'm here with Robert Lugens, our Head of Discovery Biology. 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 disclaimer. 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 achievements before handing over to Robert, who will review our clinical and preclinical pipeline I will then review our 2022 full-year financial results. Following that, we will open the call for Q&A. Our partner, Janssen Pharmaceuticals, continued to make excellent progress in executing their Global Phase II study in epilepsy patients with ADX 71149. 71149 is part one of the study and progressed to part two. An independent interim review committee has been established by Janssen to review the data from part one and make a recommendation on the future direction of the study. We expect to announce the recommendation from this independent interim review committee early in Q2 this year. We continue to believe there is value in Dip for Glorant and have substantially completed our evaluations of future development. We have identified post-stroke recovery and pain as interesting areas for future development in addition to PD-LID. However, we are currently pursuing collaborative arrangements to advance future development. We continue to be excited by our preclinical pipeline, which has made excellent progress with multiple clinical candidates rapidly advancing towards IND-enabling studies. We've selected a drug candidate in our mGluR7-NAMM program for stress-related disorders, including post-traumatic stress disorder, and are progressing this drug candidate into IND-enabling studies. We expect to start dosing in these studies in the second half of this year. We also continue to progress several backup compounds from differentiated chemicals in the candidate selection phase. We have made substantial progress in our collaboration with our partner Indivior in advancing several novel GABA-B PAM compounds into clinical candidate selection. As a reminder, Indivior's primary interest is in substance use disorder, and under the agreement, we have retained the right to select drug candidates for development in certain exclusive reserved indications, including Charcot-Marie-Tooth 1A neuropathy, chronic cough, and pain. During 2022, We extended our collaboration with Indivior, and Indivior agreed to provide us with additional research funding of $1.8 million. We expect Indivior and ourselves to select compounds to advance into IND enabling studies in early 2024. Our mGluR2 NAMM program for mild neurocognitive disorders associated with Alzheimer's disease, Parkinson's disease, and depression ran into some challenges during clinical candidate selection phase. So we've gone back into lead optimization. Last but not least, our M4PAM program for schizophrenia continues to make rapid progress through lead optimization. M4PAM is a particularly exciting target for schizophrenia, especially following the recent positive phase 3 data from Karuna. Following the inconclusive data from our blepharospasm clinical study and the termination of dipreglans development in PD-LID due to slow recruitment rate attributed to COVID-19 pandemic-related constraints, we have completed the close down of the studies and implemented a number of cost-saving measures. These cost-saving measures have significantly reduced our monthly cash burn going forward And as of today, we estimate that our cash reserves provide us with a runway through the end of Q3 2023 and enough time to secure a partnership to strengthen our balance sheet and provide resources to advance our portfolio. Now I will hand over to Robert, who will give you some more details about our exciting pipeline. Thanks, Tim. Hello, Robert.

I will start by saying that we are very excited about the opportunity to work with you.