Miromatrix Medical Inc. (NASDAQ:MIRO) Q1 2023 Earnings Conference Call May 11, 2023 6:00 PM ET

Company Participants

Hannah Jeffrey - Gilmartin, Investor Relations

Jeff Ross - Chief Executive Officer

Jim Douglas - Chief Financial Officer

Conference Call Participants

Alex Nowak - Craig-Hallum Capital Group

Operator

Greetings and welcome to the Miromatrix Medical, Inc. First Quarter 2023 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Hannah Jeffrey Gilmartin, Investor Relations. Thank you. You may begin.

Hannah Jeffrey

Good afternoon and thank you for joining us. Earlier today, Miromatrix released financial results for the quarter ended March 31, 2023. 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, May 11, 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 first quarter 2023. During our full year 2022 earnings call I communicated that we are focusing the majority of our resources on miroliverELAP in the near term to address the items identified within the clinical hold letter we received from the FDA regarding our IND submission. Our goal is to submit a full response to the FDA clinical hold butter in the second half of 2023. We envision gain clearance to treat patients with acute liver failure shortly thereafter.