Miromatrix Medical Inc. (NASDAQ:MIRO) Q2 2023 Earnings Conference Call August 14, 2023 4:30 PM ET

Company Participants

Max Forgan - Gilmartin Investor Relations

Jeff Ross - Chief Executive Officer

Jim Douglas - Chief Financial Officer

Conference Call Participants

Alex Nowak - Craig-Hallum

Phillip Dantoin - Piper Sandler

Operator

Good day, and welcome to the Miromatrix Medical, Inc. Second Quarter 2023 Earnings Conference Call. All participants’ will be in listen-only mode. [Operator Instructions] Please note this event is being recorded.

I would now like to turn the conference over to Max Forgan with Gilmartin Investor Relations. Please go ahead.

Max Forgan

Good afternoon and thank you for joining us. Earlier today, Miromatrix released financial results for the quarter ended June 30, 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 material risks and uncertainties associated with our business, please see our filings with Securities and Exchange Commission. The information provided in this conference call speaks only to the live broadcast today, August 14, 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.

With that, I will now turn the call over to Jeff.

Jeff Ross

Thanks, Max. Good afternoon, and thank you, everyone, who has joined us for today's earnings call. We continue to make significant progress on addressing the items identified within the FDA clinical hold letter, relating to our miroliverELAP IND submission. Our goal remains to submit a full response to the FDA in the second-half of 2023, and we envision gaining authorization to treat patients with acute liver failure shortly thereafter.