Miromatrix Medical Inc.

Greetings and welcome to Miro Matrix Medical, Inc. First Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during today's conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn this conference over to your host, Ms. Hannah Jeffries from Gilmartin. Thank you, ma'am. You may begin your presentation at this time.

Good afternoon, and thank you for joining us today. Earlier today, Miro Matrix released financial results for the quarter ended March 31st, 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 the filing of the IND application from NeuroLiver ELAP and the initiation of the related clinical trial, 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 material 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 16, 2022. Miro Matrix 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.

Thanks, Hannah. Good afternoon, and thank you to everyone who has joined us today for our first quarter 2022 earnings call. Today I'll start with a brief overview of MiroMatrix to remind everyone of our positioning and differentiation, followed by a business update from our first quarter before turning the call over to our CFO, Jim Douglas, for a financial review. MiroMatrix is positioned as a life science company dedicated to pioneering a novel technology for bioengineering fully transplantable organs to help save and improve patients' lives. We are one of a small group of companies at the forefront of developing alternatives to human donor organ transplants. We are differentiated versus other technologies in the category by our proprietary technology platform that utilizes a two-step decelerization and resellerization process to bioengineered organs for transplant into humans. While our initial focus is on bioengineering livers and kidneys, our technology platform is also applicable to all organs. Among several differentiating benefits of our technology platform that I've previously discussed and are included in our public filings, I'd like to highlight two of them again today. First, we believe our bioengineered organs will not be classified as xenotransplantation because our decelerization step removes all living biologic material from the porcine organs. We believe this is a significant regulatory distinction versus xenotransplantation technologies. such as gene editing. Second, we believe our bioengineered organs will have a favorable rejection profile similar to donated organs because our receleration step recedes the decelerized porcine organ matrix with unmodified human cells. We believe this is a significant clinical distinction. Our technology differentiation continues to be appreciated by more and more people in the field, and I'd like to highlight some notable industry events that we have recently attended. In March, we participated in CareDx's Xenotransplantation Innovation Day, a symposium that brought together experts in the transplant field. In April, we presented at the 2022 Gene and Cell Meeting on the Mediterranean. And in May, we were highlighted at a National Kidney Foundation event. At these events, it was evident that people understand that transplant is one of the largest unmet medical needs in the world. And importantly for us, these audiences gained an appreciation for the differentiated nature of our solution. Now I'd like to provide status updates on our three lead product candidates. Mural Liver ELAP is our external liver assist product that is designed to treat acute liver failure patients. Mural Liver ELAP consists of an external perfusion system and our bioengineered liver that will reside outside the human body to provide temporary liver support in an ICU setting. In early March, we received a formal response from the FDA regarding our pre-IND submission. We remain on track to file an IND application for mural liver ELAP in the second half of 2022. Following IND clearance from the FDA, we plan to initiate a phase one clinical trial. MuroLiver, our fully implantable bioengineered liver, is intended to treat acute and chronic liver failure patients. In collaboration with the Mayo Clinic, we published a 2021 study in Nature Communications Biology announcing the heterotopic implant of our bioengineered livers into large animals. The study provided excellent proof of concept as we progressed towards human clinical trials. We have had consultations with the FDA And we remain on track to submit our pre-IND request in 2023. Similar to mural liver ELAP, after the FDA responds to our pre-IND submission, we'll have a better sense of timing regarding filing our IND application for mural liver and our path to the clinic. Mural kidney, or fully implantable bioengineered kidney, is intended to treat patients with end-stage renal disease. We remain on track to submit our pre-IND request in 2023. Consistent with our other programs, after the FDA responds to our pre-IND submission, we will have a better sense of timing regarding filing our IND application for mural kidney and our path to the clinic. On the operational front, we recently hosted a ribbing cutting ceremony for the grand opening of our new headquarters. This world-class facility provides us with in-house manufacturing capabilities allowing us to control our development timelines and quality throughout clinical trials. It was a very well-attended event, and we had several news organizations present that produced content that has been shared on several media outlets. Finally, I'd like to acknowledge the efforts of Laji Katengal, our Vice President of Quality, who will be transitioning from Neuromatrix at the end of July for health and personal reasons. Laji is a multi-organ transplant recipient who joined Mural Matrix in large part because of his belief in our mission and the potential impact our technology holds for patients in need. Laji consistently has been a driving force on our team as we strive to make bioengineered organs a reality. We wish Laji all the best, and we are pleased that he will continue to lead our quality team as we search for a successor to ensure a seamless transition. Thank you for your continued support. I will now turn the call over to Jim Douglas, our Chief Financial Officer, to discuss our financial results in the first quarter of 2022.