AUTL - Autolus Therapeutics plc (AUTL) Q1 2024 Earnings Call Transcript

2024-05-17 12:55:25 ET

Autolus Therapeutics plc (AUTL)

Q1 2024 Earnings Conference Call

May 17, 2024 8:30 AM ET

Company Participants

Olivia Manser – Investor Relations

Christian Itin – Chief Executive Officer

Rob Dolski – Chief Financial Officer

Conference Call Participants

Kelly Shi – Jefferies

James Shin – Deutsche Bank

Asthika Goonewardene – Truist

Matthew Phipps – Blair

Gil Blum – Needham & Company

Presentation

Operator

Hello, ladies and gentlemen, and welcome to the Autolus Therapeutics' Call to discuss its First Quarter 2024 Financial Results and Business Updates. As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host, Olivia Manser. Please go ahead.

Olivia Manser

Thanks, Tanya. Good morning or good afternoon, everyone. Thanks for joining us on today's call. With me are Dr. Christian Itin, our CEO; and Rob Dolski, our CFO. So, on Slide 2, before we begin, I'd just like to remind you as usual that during today's call we will make statements related to our business that are forward-looking under federal securities laws and the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These may include, but are not limited to, statements regarding the status of clinical trials and development and/or regulatory timelines for our product candidates and our expectations regarding our cash runway.

These statements are subject to a variety of risks and uncertainties that could cause actual results to differ materially from expectations and reflect our views only as of today. We assume no obligation to update any such forward-looking statements. For a discussion of the material risks and uncertainties that could affect our actual results, please refer to the risks identified in today's press release and our SEC filings, both available on the Investors section of our website. So, moving on to Slide 3, you're going to see the agenda for today's call, which is similar to usual.

So Christian is going to provide an overview of our operations highlights. Rob will then take you through the financial results, and Christian will conclude with upcoming milestones and we'll then hand over for questions.

So with that, I will hand over to Christian.

Christian Itin

Well, thank you very much, Olivia, and welcome everybody to our first quarter call. It's been a very successful quarter and obviously with a lot of activity related to Obe-cel, but also obviously quite a lot of overall corporate updates as well. I'll start out with Obe-cel. We started the year with the acceptance of our BLA filing, which obviously was an important event, and also set the target date for the PDUFA, which is expected now for November 16. We also managed by the – and towards the end of the quarter to get the European filing accepted. So we have now both major jurisdictions to filings under review.

What was very important, because it led to also the overall preparedness of the company towards the commercialization, was the inspection that we had of the Nucleus facility by the MHRA that was very successful and resulted in a license for both clinical and commercial supply from the facility, from the Nucleus facility. What's important to understand is that this is actually a prerequisite for us to actually be able to commercially deliver product, and that is a necessary license that we actually need to hold....

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