Miromatrix Medical Inc. (NASDAQ:MIRO) Q4 2022 Earnings Conference Call March 31, 2023 4:30 PM ET

Company Participants

Hannah Jeffrey - Investor Relations

Jeff Ross - Chief Executive Officer

Jim Douglas - Chief Financial Officer

Conference Call Participants

Phillip Dantoin - Piper Sandler

Alex Nowak - Craig-Hallum Capital Group

Operator

Greetings and welcome to the Miromatrix Medical, Inc. Fourth Quarter and Full Year 2022 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Hannah Jeffrey with Investor Relations. Thank you, Ms. Jeffrey, you may begin.

Hannah Jeffrey

Good afternoon and thank you for joining us. Earlier today, Miromatrix released financial results for the fourth quarter and full year ended December 31, 2022. The release is currently available on the company’s website at www.miromatrix.com. Jeff Ross, Chief Executive Officer; and Jim Douglas, Chief Financial Officer, will host this afternoon’s call.

Before we get started, I would like to remind everyone that management will be making statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that are not statements of historical fact, including statements regarding the potential timing of pre-IND and IND filings, and the initiation of related clinical trials, future expenses and revenue, capital requirements, cash runway and needs for additional financing should be deemed to be forward-looking statements. All forward-looking statements are based upon current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated or implied by these forward-looking statements.

Accordingly, you should not place undue reliance on these statements. For a list and descriptions of the materials, risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission. The information provided in this conference call speaks only to the live broadcast today, March 31, 2023. Miromatrix disclaims any intention or obligation, except as required by law, to update or revise any information, financial projections or other forward-looking statements, whether because of new information, future events or otherwise.

I will now turn the call over to Jeff.

Jeff Ross

Thanks, Hannah. Good afternoon, and thank you to everyone who has joined us today for our fourth quarter and full year 2022 earnings call. The past year was very rewarding and challenging at the same time. One of the most rewarding accomplishments was the submission of our IND application for miroliverELAP in November. We believe this was the first IND submission for a bioengineered organ therapy putting us on the forefront of pioneering a new class of therapies to treat patients suffering from organ failure. The FDA then notified us in December that our IND application was placed on clinical hold. And in January, we received the formal clinical hold letter from the FDA, detailing the specific deficiencies and the information needed to resolve the clinical hold. After evaluating the clinical hold better internally, and with our outside advisers, we remain optimistic about the ultimate success of miroliverELAP. We are focused on providing patients with acute liver failure access to miroliverELAP as soon as possible. And over the coming months, we will focus our efforts on resubmitting the IND in the second half of 2023, with the goal of gaining IND clearance from the FDA shortly thereafter.