Axcella Health Inc. (NASDAQ:AXLA) Q3 2022 Earnings Conference Call November 1, 2022 8:30 AM ET

Company Participants

Bill Hinshaw - President & CEO

Bob Crane - CFO

Margaret Koziel - CMO

Conference Call Participants

Thomas Yip - H.C. Wainwright

Operator

Good morning, ladies and gentlemen, and welcome to Axcella’s third quarter 2022 conference call. Please be advised that today’s call is being recorded, and that all participants will be in a listen-only mode until the question-and-answer session. [Operator Instructions]

Now, for opening remarks, I would now like to hand the call over to Bob Crane, Chief Financial Officer at Axcella. Please go ahead, sir.

Bob Crane

Thank you very much, operator, and good morning, everyone. We would like to advise that certain remarks we will make on today’s conference call, such as those relating to our cash runway and our ongoing clinical trials of AXA1125, include forward-looking statements that are subject to various risks and uncertainties. These risks and uncertainties are detailed in our SEC filings, including our most recent Form 10-Q, which we plan to file later today. These filings can be accessed on our website, axcellatx.com, or on the SEC website. All forward-looking statements represent our views as of today, November 1, 2022, and should not be relied upon as representing our views as of any subsequent date. We undertake no obligation to update these forward-looking statements.

With that, let me turn the call over to our President and CEO, Bill Hinshaw to begin the discussion. Bill?

Bill Hinshaw

Thank you, Bob, and good morning, everyone. It's a pleasure to be speaking with you again. This has been an extremely exciting period for Axcella, and today, I will briefly review the progress we've made during the past quarter. Following my opening remarks, Bob will then update you on the financials. Through the third quarter, we made important progress in our clinical development of AXA1125, and strengthened our balance sheet with a new financing. Now, on August 2, we announced positive topline results from our Phase 2a study of AXA1125 in long COVID. Long COVID is a persistent and growing challenge of the pandemic, affecting an estimated 100 million patients worldwide, with fatigue as the most common symptom reported. Indeed, Time Magazine has described long COVID as the greatest mass disabling event in history. The fatigue that is experienced by long COVID patients, just both mental and physical, is often so severe that they are unable to work, exercise, or engage in normal activities of daily life. And until our study, no previous pharmaceutical agent had demonstrated the ability to improve outcomes for patients with long COVID in a randomized controlled trial. So, we set out to develop AXA1125 to offer treatment options to seriously ill long COVID patients who previously had none.