Miromatrix Medical Inc.

Greetings and welcome to the Miro Matrix Medical Inc. first quarter 2023 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 the conference, please press star zero on your telephone keypad. 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.

Good afternoon, and thank you for joining us. Earlier today, Miro Matrix released financial results for the quarter ended March 31st, 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 law, 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 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'll now turn the call over to Jeff.

Thanks, Hannah. Good afternoon, and thank you to everyone who has joined us for our first quarter 2023 earnings During our full year 2022 earnings call, I communicated that we are focusing the majority of our resources on mural liver ELAP 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's clinical hold letter in the second half of 2023. We envision gaining clearance to treat patients with acute liver failure shortly thereafter. Since our year-end earnings call, we have made significant progress on addressing the items identified within the clinical hold letter, and I'll share some of those updates with you today. As you recall, a couple of the longer lead items that we are addressing relate to a biocompatibility study and a preclinical animal study regarding biocompatibility. The FDA requested that we do additional testing regarding the final finished fluid path comprised of third-party components. The biocompatibility testing we submitted on our liver graft as part of the IND was not part of the FDA's question, only the third-party components. We believe this is low risk, however it takes time. The other item that has contributed to our extended timelines was the request for an additional animal safety study consisting of six animals, three to be treated with mural liver ELAP and three controlled. This is smaller than our original safety study. In the original animal safety study, there was no evidence of systemic toxicity in the mural liver elab group or the control group. However, there was substantial morbidity in all groups due to the immobilization and anesthesia required to provide therapy in a pig model, which makes longer therapies in the mobilized animal model challenging. The new protocol will use improved anesthesia and immobilization techniques in an attempt to reduce morbidity in all animals. The revised protocol may also allow us to extend treatment duration in the safety study. We plan to begin treating animals this quarter with the goal to complete the safety study in the coming months. In addition to the clinical hold work, we are progressing with our manufacturing and clinical readiness plans to ensure that once we obtain IND clearance, we can quickly initiate our phase one clinical trial. This involves ensuring our manufacturing process meet GMP standards and the clinical trial sites are identified. Currently, we are engaged with 15 potential clinical sites that are highly interested in being part of our clinical trial, and we will ultimately move forward with eight of them. Each site will be consigned a Baxter Prismac system, running the software developed specifically for mural liver ELAP. The positive response from the potential clinical sites continues to highlight both the need for an effective therapy and our potential to deliver it. In summary of the status update for mural liver ELAP, we believe that we are taking all of the necessary steps to permit us to submit a thorough response to the FDA's clinical hold letter in the second half of this year. We believe prioritization of Mural Liver ELAP at this time provides us with the fastest path to treating organ failure patients with our bioengineered organs. And we believe this could also provide important validation to our entire bioengineered organ platform. After this in-depth discussion around Mural Liver ELAP, it's important for me to reiterate that we remain very enthusiastic about our fully implantable bioengineered organ programs. While we are progressing these programs at a slower pace until mural liver ELAP gains IND clearance, we could reinvigorate any of them if the appropriate partnership arises or circumstances otherwise change. A recent example highlighting our fully implantable bioengineered organ program is our partnership with CARDI-X to develop novel testing solutions to assess organ rejection via a simple blood test. We are honored to be working with CARDI-X, the leader in the existing transplant industry, for such testing. We are grateful that they comprehend the magnitude of the unmet medical need that we are trying to address with our bioengineered organs. In closing, I'd like to share some valuable information interactions that I had earlier this month at the annual cell and gene meeting on the med in Barcelona, Spain. As I was asked to moderate a panel titled the pioneer tax challenges and opportunities of being at the forefront of innovation consisting of executives from four leading cell and gene therapy companies in addition to myself. All of the executives shared stories about developing novel cellular and gene therapies And similar to MiroMatrix, their paths weren't always easy. All of the companies dealt with challenging setbacks and notably four of them were placed on clinical holds prior to treating their first patient. To their credit, they all stayed the course and delivered medical advancements and stakeholder value. We look forward to delivering similar advancements to the transplant community as well as our stakeholders. I will now turn the call over to Jim Douglas our Chief Financial Officer, to discuss our financial results, and I hope to see many of you at the upcoming American Transplant Congress, where we will be presenting.