3/13/2023

speaker
Gary
Conference Operator

Good afternoon. My name is Gary, and I will be your conference operator today. At this time, I would like to welcome everyone to the Amelix Pharmaceuticals fourth quarter and full year 2022 earnings conference call. All participants will be in listen-only mode. After today's presentation, there will be an opportunity to ask questions. To ask a question, please press star 1 on your telephone keypad. To withdraw your question, please press star 2. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to Lindsay Allen, Head, Investor Relations and Communications. Please proceed.

speaker
Lindsay Allen
Head, Investor Relations and Communications

Good afternoon, and thank you for joining us today to discuss our fourth quarter and fourth year 2022 earnings. With me on the call are Josh Cohen and Justin Klee, our co-CEOs, Margaret Olinger, our Chief Commercial Officer, and Jim Friedes, our Chief Financial Officer. Before we begin, I would like to remind everyone that any statement we make or information presented on this call that are not historical facts are forward-looking statements that are based on our current beliefs, plans, and expectations, and are made pertinent to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, our expectations with respect to Relivrio and Albreoza, statements regarding regulatory development and the expected timeline thereof, our business strategy and outlook, and our expected financial performance and cash runway. Actual events and results could differ materially from those expressed or implied by any forward-looking statements as a result of various risks, uncertainties, and other factors, including those set forth in our most recent filings with the SEC and any other future filings that we may make with the SEC. You are cautioned not to place any undue reliance on these forward-looking statements, and Amelex disclaims any obligation to update such statements unless required by law. Now, I will turn the call over to Justin.

speaker
Justin Klee
Co-CEO

Thank you, Lindsay, and good afternoon, everyone. Our mission is to one day end the suffering caused by ALS and other neurodegenerative diseases. We just celebrated Amelix's 10th birthday, and as we look back, we are very proud of the progress we've made toward our mission over those 10 years. 2022 was, in many ways, the most important year for us. with the FDA approval of Relivrio for the treatment of adults with ALS in the U.S., following its approval with conditions as Albreoza in Canada. ALS is a relentlessly progressive and universally fatal disease, and Relivrio is the first approved treatment for ALS to demonstrate both a statistically significant benefit in function in the clinical trial, as well as an observed benefit on survival in a longer-term post-hoc analysis. We believe our therapy represents a meaningful advancement in treatment options for people living with ALS. Since the approval, we have seen strong interest in Relivrio, and we are encouraged by the early success of our commercial launch. We are very proud of our team for the way they have partnered with the ALS community, and for the great progress they've made toward our goal of delivering Relivrio to every eligible person in the U.S. and Canada. But this is also just the start. And all of us at AMLEX remain steadfast and committed to the work ahead in our commercial launches and as we work to transform what it means to be diagnosed with ALS. I will now pass to Jim to review our fourth quarter financial results and then to Margaret to share insights on our launch.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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