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00:39 Thank you, Debbie. Good afternoon, and thank you for joining us today.

Earlier today, Miromatrix released financial results for the quarter ending September thirty twenty twenty one. The release is currently available on the company's website at www.miromatrix.

com. Jeff Ross, Chief Executive Officer; and Brian Niebur, Chief Financial Officer will host this afternoon's call.

01:03 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 the Federal Securities Laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of nineteen ninety five. Any statements contained in this call that are not statements of historical fact, including statements regarding our examination of operating trends, expectations regarding coverage decisions, pricing and enrollment matters and our future financial expectations and results 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, November fifteen, twenty twenty one. 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.

02:32 I will now turn the call over to Jeff.

02:37 Thank you, Greg. Good afternoon, and thank you for joining us for the third quarter twenty twenty one earnings conference call.

Before we get into details, I would like to take a moment to acknowledge that this is our first earnings call since we completed our IPO and NASDAQ listing in June. I would like to take this opportunity to say thank you to all those who participated in the offering which raised approximately fifteen million dollars in gross proceeds.

And to those who have invested in the company since. I would also like to again thank the entire Miromatrix team and our Board of Directors, with all of your support we are well positioned to take the next step towards our goal of bioengineering fully transplantable human organs to help save and improve patients’ lives 03:26 While many of you have had a chance to hear our story during our IPO process, I'll start today with an introduction to Miromatrix before moving on to cover recent updates and our vision for the future.

Lastly, Brian will address our financial results before we open the lines for questions. 03:44 Miromatrix is a life sciences company pioneering a novel technology for bioengineering fully transplantable human organs.

Organ disease is a significant public health issue. According to the American Transplant Foundation roughly one hundred and fourteen thousand people in the United States waiting for lifesaving organ transplant, In every ten minutes, another person is added to the waitlist.

04:09 Unfortunately, sixty percent of those on the waitlist are around seventy thousand patients who will not receive the organ they need. That means, around seventy thousand patients will be pre-screening to receive a life-saving transplant, but will not get the opportunity to receive one.

This leads to an approximately twenty people dying every day in the United States due to the lack of available organ, while on the waitlist. 04:35 The number of registered organ donors in the U.S.

have continued to increase. And as of twenty twenty one hundred and sixty nine million people in the U.S.

have registered to be donors. Despite this increase, the supply of available organs remains a fraction of the demand.

According to the Health Resources and Services Administration, less than one percent of all deaths meet the specification -- the specific medical criteria to be a donor. 05:03 That being said, if the entire population in the United States were organ donors, the number of available organs would only double leaving at least thirty five thousand patients still today waiting for an organ this year.

This simply can't be solved with more donations. With the current demand for organ outweighing the supply many times over, we knew something had to be done.

To increase supply, we have developed a proprietary perfusion technology platform for bioengineering organs that we believe has the potential to efficiently scale to address the shortage of available organs. Our initial development focus is on human liver and kidneys.

We have demonstrated the ability to bioengineering these organs with functional vasculature, an important organ function on the bench. 05:55 And in preclinical studies, some of which we recently published.

In addition, we believe our technology platform will be able to develop other organs, including lungs, pancreas, and hearts. Our proprietary perfusion platform is comprised of two technology platforms, decellularization and recellularization.

Decellularization is the process of removing the cells from the harvested porcine organs leaving behind a scaffold of extracellular matrix or ECM. 06:28 That retains the architect, mechanical properties and vascular network of the original organ structure.

Porcine ECM is estimated to be over ninety three percent homologous to human ECM or similar to human ECM, which significantly reduces the potential four antibody formation and adverse reaction. Recellularization is the process of growing new functional organs starting with the ECM.

We currently use living human cells harvested from donated organs unsuitable for transplant to receive the ECM and in the future intend to develop new techniques using patient derived stem cells. This process occurs in a bioreactor where media in the living human cells are perfused into the ECM in the appropriate sequence in order to facilitate cellular regeneration and organ functionality.

07:24 Our multi oriented technology is protected by over one hundred and eighteen issued patents and thirty five pending patent applications worldwide, with protection in the United States and major markets worldwide. Also, our manufacturing process is highly scalable and utilizes off the shelf bioreactors and other equipment.

07:45 We believe the organs we are developing could have significant functional and immunological advantages compared to other organ development techniques that rely on animal cells, genetic modification, such as xenotransplantation, Recently, there was news of a successful xenotransplantation of a kidney performed at NIU Langone Health. In this process, the alpha gal gene from porcine kidney was knocked out in the pig's thymus gland was transplant with the kidney to save off immune response.

Throughout the fifty four hours, the patient remained on life support, no signs of rejection were detected. While this is exciting news, xenotransplantation is not a new concept, transplanting porcine organs into humans has been tried many times, but with little success due to hyperacute rejection.

08:41 Regarding our bioengineered organ platform, the first of our program is our external liver assist study. In this Phase I study, we intend to assess the function of our bioengineering liver in humans utilizing our external liver assist product or ELAP to provide external temporary liver support to human participants with acute liver failure.

Currently, there are no successful therapies for acute liver failure, except transplantation, leading to approximately thirty percent of these patients dying. If successful, we believe that data will help to expedite our clinical pathway to full organ transplantation.

We are on track to follow-up -- to file our pre investigational new drug or IND – pre-IND submission by the end of the year with plans to file the IND submission in the first half of twenty twenty two for the use of our ELAP system to treat acute liver failure. If approved by the FDA, we expect to initiate this study in the second half of twenty twenty two and have data in early twenty twenty three.

09:54 Upon a successful external liver assist study, we plan to use the data from this study as well as additional preclinical data we intend to generate to file IND to begin Phase I studies for transplant of our bioengineering livers and kidneys in humans, which could potentially begin in late twenty twenty three or early twenty twenty four. 10:18 We were excited to recently publish a major communications biology, some of our exciting preclinical work.

The preclinical study was performed at the Mayo Clinic and designed to assess a bioengineered liver -- bioengineered livers initial transplantation and functionality in an acute liver failure model. It utilized decellularized porcine liver scaffold, recellularized with human vascular cells and porcine hepatocytes, which were implanted into pig suffering from acute liver failure.

The results showed that pigs that received the bioengineered liver maintain detectable hepatic health in the graph, sustained blood perfusion and demonstrated early liver function post transplantation. 11:02 The successful completion of these transplant demonstrates the efficiency of bioengineering whole organs through the process of decellularization and recellularization, an exciting advancement given the chronic shortage of donor organs for liver failure patients.

In addition to these results, we continue to grow the senior management team, we're excited to welcome John Barry as the VP of R&D to Miromatrix. We plan to add additional senior management over the next two quarters as we increase our depth and talent.

11:35 Lastly, we started our new facility build out following our IPO, and we are on schedule to complete our move to this new facility by the end of the year. We will be increasing our square footage from twelve thousand to a little over forty thousand square feet.

The new facility will allow us to manufacturing discussion of our financial results in third quarter.

11:57 Thanks, Jeff. Miromatrix expects to generate revenue from our proprietary bioengineered organ platform upon commercialization.

Upon commercialization revenue gross margin estimates will be provided in a more regular cadence. 12:13 Expenses for the third quarter of twenty twenty one were three point three million dollars compared to one point nine million dollars in the third quarter of twenty twenty.

The increase was primarily driven by an increase in employee cost in lab supplies, partially offset by a decrease in contract preclinical expenses. General and administrative expenses for the third quarter of twenty twenty one were one point five million dollars compared to zero point five million dollars in the third quarter of twenty twenty.

12:44 The increase in general and administrative expense was primarily due to increase in employee costs, legal and accounting expenses, consulting expenses or compensation expense and insurance expenses. These increases can primarily be attributed to the costs of being a public company.

13:02 Net loss for the third quarter was five point one million dollars, equating to a loss of zero point two five dollars per share as compared to a net loss of three million dollars or a loss of one point three seven dollars per share for the same period of the prior year. 13:16 We ended the quarter with sixty two point one million dollars of cash, our net cash usage for the third quarter of twenty twenty one was four point four million dollars.

We expect our net cash usage to increase in the fourth quarter to continue to build out our infrastructure in preparation for our first clinical trial. 13:35 And with that, I'll turn the call to the operator for questions.

14:13 Great. Good afternoon, everyone.

You guys have had two big building block studies here in Nature, one adding human endothelial cells, then the second one focused on hepatocytes. What other big building block animal studies or publications should we expect over the next twelve months?

14:29 Yeah. Thanks, Alex.

It's good to hear from you on that standpoint. Excited both of -- as what you talked about, both of those studies.

I mean, if you look at that first study, it really set up in our mind solving the vascular challenge and demonstrating that we can revascularize a substrate, put that back into a large animal model and we can see that continuous perfusion. The second one that I mentioned is that, you referenced there as well is then, adding in this case liver specific cells, the hepatocytes to set that up.

14:59 In our mind, as we look at the Phase I clinical study for the ELAP, I think from that standpoint, we have all the publications we need to continue to move forward with that study and focus on that as our clinical milestone for next year. I think in addition to that, you'll see over time as we go towards the fully transplantable you should continue and look for additional preclinical studies that just further prove out different ways of looking at those organs being transplant.

15:35 Just from the animal studies, how long could these animal studies actually last with a recellularized organ just given some of the immuno and compatibles that are out there?

15:48 Right, right. And I think you hit on a key point, and we covered that in some of our publications as well.

And the notion there that people have to realize is, we're developing human organs for transplant. And one of those challenges is, what's the preclinical model that you're going to transplant these back in knowing that we're creating that human transplant.

So we'll always have that immune challenge of taking a human organ and placing that into a large animal model to demonstrate long term viability because we're going to have that rejection. That rejection that we see in the animal, we don't anticipate to see that in humans, because in humans if human cells back into humans, which is really one of the key things of our platform is the fact that we are building these organs with full human cells.

16:41 Yes. That makes sense.

Can you expand on some of the pre IND questions that you're planning on to ask in the FDA here by the end of this year? And how the feedback there is going to modify your plans for the full IND for first half of twenty twenty two?

16:58 We feel we got a really good plan going into the pre-IND in terms of outlining exactly what we think the IND enabling studies are. And remember, all those are structured in terms of what we'll be looking for and presenting into the FDA.

So we're really going into that with the notion of getting reinforcement on what we feel as a very solid plan. But obviously, if the agency comes back with some modifications, we're in a position to quickly adjust for those.

We've been working on the models, we've been working on the system. So, we feel we're in a good spot, but until we get that one hundred percent clarity, you never completely know.

17:43 Yes. No, that makes sense.

And on the lab validation for the new facility, is the plan to get the lab completely validated and signed off from a GMP perspective by the end of this year? Or is that validation to occur early in twenty twenty two.

Just thinking about how the pre-IND and and then the IND could be structured, because of the reason that old facility as kind of the reference set or the new facility?

18:07 Yes, a little bit of both on that front, we really designed a new facility in terms of the square footage in the size of the clean room. In part of our design associated with that, we designed a portion of this really to support just our human clinical studies and with design controls and stuff like that really put in place.

That validation which is the most important part of the validation will take place in early twenty twenty two. But in a phase appropriate manner that still allows us a clear lead time to be able to then be able to manufacture that and support what we're targeting second half of next year to initiate our human clinical studies.

18:49 All right. And just two more questions, Just any plans or timelines here for exploring special FDA designations on this, such as RMAT breakthrough fast track?

19:01 Yeah. I mean, great question, Alex, and our regulatory team is always asking me these these questions as well, just because of the applicability of what we're doing.

So, we continue to look at RMAT. And one thing with RMAT is you do need to have prior clinical experience, right?

So for Phase I we wouldn't apply yet, that would be the follow on or potentially using some of that data as go after our fully transplant to leverage it there. Fast track is certainly always an option just given, again, that we're creating products both in the EKAP and longer term on the fully transplantable where there's really no alternative therapies, right?

I mean, therapies are out there, it's transplant. But as I talked about in the transcript, there's just not an enough organ.

So we have this huge lack of available technology for patients, which we feel certainly would fit into some of these FDA designations, whether it's fast track, or RMAT after we have some clinical experience.

20:05 Okay, got it. And then just last question, has there been any changes to or can you remind us the trial design for the liver assist in human study, design of the trial, length of the trial protocol, etcetera?

20:18 Yeah. So, we had some of that outlined in our S1.

And certainly part of our pre-IND meeting -- discussion with the FDA and then leading into the IND submission is really getting tight on what that clinical protocol is looking at all aspects. What we're targeting today is having that therapy for the patients up to X number of days and what we're targeting today, we talked about in the S1 up to seven days of continuous therapy.

We'll be looking at that and talking to the agency about this. We may have to scale back on those days slightly just from a risk standpoint initially and then how we build up to some of those.

21:01 I think if you are thinking about the trial design, our goal is to be able to deploy this in acute liver failure patients, have that liver set up externally and then be able to -- Phase I is really around the safety standpoint, demonstrate the safety of our graft on the patient and then look at that duration. I think what's unique about this right is, we'll still be able to as we talked about inside of the S1 is, you're still going to be able to sample blood in the patient during that time, to also look at secondary endpoints, which the Phase 1 won't be powered for, but potentially start to look at some of that functionality as well.

21:43 That's great. Looking forward to watching the progress.

Thank you.

21:46 Thank you, Alex.

22:00 Great. Thank you, Debbie.

And thank you all for joining the call today. We look forward to keeping you informed on our business and clinical milestones.

Have a great day.