AXCELLA HEALTH INC (NASDAQ:AXLA) Q2 2020 Earnings Conference Call - Final Transcript

Aug 05, 2020 • 08:30 am ET

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AXCELLA HEALTH INC (NASDAQ:AXLA) Q2 2020 Earnings Conference Call - Final Transcript

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Presentation
Operator
Operator

Good day and welcome to Axcella's Top Line Data Conference Call. [Operator Instructions] Please note, this event is being recorded.

I would now at this time, let's turn the conference over to Jason Fredette, Vice President of Investor Relations and Corporate Communications. Please go ahead.

Executive
Jason Fredette

Thanks, Ian and thanks everyone for joining us this morning. About an hour ago, we issued a press release and filed an 8-K containing our second quarter financial results as well as our top line data for our AXA 1665-002 clinical study. We also posted a presentation to our website that will be used as a guide for our call today. Those documents can be accessed by going to axcellahealth.com and going to the Investors and News section. Please access those slides now if you haven't already done so.

On the call with me today are Axcella's President and CEO, Bill Hinshaw; and our Chief Medical Officer, Dr. Manu Chakravarthy. Other members of management are on the line to take part in the Q&A session. But first, please go to Slide two of our presentation and you will see our Safe Harbor statement.

We would like to advise that certain remarks we make on today's conference call will be forward-looking, including those related to our expected regulatory engagements and our planned clinical trials under IND. These are forward-looking statements and are subject to certain risks and uncertainties that are detailed in our Form 10-Q for the most recent quarter and our other SEC filings. Those filings can be accessed on IR website or the SEC's website. All forward-looking statements represent our views as of today, August 5, 2020 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.

On Slide three, you will see a description of Axcella's development model and its clinical approach. The data we are recording today are generated in non-IND clinical study that was designed to evaluate the product candidates for safety, tolerability and effects on normal biological structures and function. The study was not designed or intended to evaluate the ability to treat or prevent a disease. Subsequent to initiating AXA 1665-002, we announced our intention to develop AXA 1665 as a therapeutic. As such, any future clinical investigations of this product candidate will be conducted under an IND filing with the FDA.

And now, I would like to turn the line over to CEO, Bill Hinshaw. Bill?

Executive
Bill Hinshaw

Well, thank you, Jason and good morning everyone. We are pleased to share our Q2 results and recap several of our recent accomplishments in today's press release. These accomplishments include positive top line data for our NASH candidate, AXA 1125, as well as the completion of a follow-on equity offering that enabled us to further strengthen our balance sheet. We are also excited to be speaking with you now about the encouraging top line data from our clinical study of AXA 1665, Axcella's product candidate for the reduction in