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

Firm Members

Max Forgan – Gilmartin Investor Relations

Jeff Ross – Chief Govt Officer

Jim Douglas – Chief Monetary Officer

Convention Name Members

Alex Nowak – Craig-Hallum

Phillip Dantoin – Piper Sandler

Operator

Good day, and welcome to the Miromatrix Medical, Inc. Second Quarter 2023 Earnings Convention Name. All contributors’ shall be in listen-only mode. [Operator Instructions] Please be aware this occasion is being recorded.

I’d now like to show the convention over to Max Forgan with Gilmartin Investor Relations. Please go forward.

Max Forgan

Good afternoon and thanks for becoming a member of us. Earlier at the moment, Miromatrix launched monetary outcomes for the quarter ended June 30, 2023. The discharge is at the moment obtainable on the corporate’s web site at www.miromatrix.com. Jeff Ross, Chief Govt Officer; and Jim Douglas, Chief Monetary Officer, will host this afternoon’s name.

Earlier than we get began, I want to remind everybody that administration shall be making statements throughout this name that embrace forward-looking statements throughout the which means of federal securities legal guidelines, that are made pursuant to the Protected Harbor provisions of the Personal Securities Litigation Reform Act of 1995. Any statements contained on this name that aren’t statements of historic truth, together with statements relating to the potential timing of pre-IND and IND filings, and the initiation of associated scientific trials, future bills and income, capital necessities, money runway and desires for extra financing needs to be deemed to be forward-looking statements. All forward-looking statements are based mostly upon present estimates and varied assumptions. These statements contain materials dangers and uncertainties that might trigger precise outcomes to vary materially from these anticipated or implied by these forward-looking statements.

Accordingly, you shouldn’t place undue reliance on these statements. For an inventory and descriptions of the fabric dangers and uncertainties related to our enterprise, please see our filings with Securities and Alternate Fee. The knowledge supplied on this convention name speaks solely to the stay broadcast at the moment, August 14, 2023. Miromatrix disclaims any intention or obligation, besides as required by legislation, to replace or revise any data, monetary projections or different forward-looking statements, whether or not due to new data, future occasions or in any other case.

With that, I’ll now flip the decision over to Jeff.

Jeff Ross

Thanks, Max. Good afternoon, and thanks, everybody, who has joined us for at the moment’s earnings name. We proceed to make vital progress on addressing the objects recognized throughout the FDA scientific maintain letter, referring to our miroliverELAP IND submission. Our purpose stays to submit a full response to the FDA within the second-half of 2023, and we envision gaining authorization to deal with sufferers with acute liver failure shortly thereafter.

As a reminder, we’re prioritizing miroliverELAP within the near-term, as a result of we consider it offers us with the quickest path to treating organ failure sufferers with our bioengineered organs. And that program offers us with priceless perception to our totally implantable bioengineered organ applications.

As I constantly talked about, we could determine to speculate extra closely into any of our totally implantable organ applications, if a partnership arises or circumstances change. Particular to miroliverELAP, you could recall a few longer lead objects that we’re addressing as a part of the scientific maintain associated to a preclinical animal examine and biocompatibility examine.

I’m completely happy to report that we commenced each research throughout the second quarter and are nearing completion for the in-life portion of the animal examine and the biocompatibility examine. As a reminder, the animal security examine has two arms consisting of eight animals in every, 4 treats and 4 controls. This security examine is smaller than our unique security examine that was submitted as a part of the IND package deal.

In our unique animal security examine, there was no proof of systemic toxicity within the miroliverELAP group or the management group. Nevertheless, there was substantial mortality in all teams as a result of immobilization strategies and the anesthesia required to supply remedy in a pig mannequin, which makes longer therapies in a mobilized animal mannequin difficult. The present security examine utilized and improved the mobilization strategies and anesthesia to scale back mortality in all animals. We’re at the moment gathering all the info referring to this examine to include into our response to the FDA.

Concerning the biocompatibility examine, the FDA requested that we do extra testing relating to the ultimate completed fluid path comprised of third-party elements. The biocompatibility testing we submitted on our liver graft as a part of the IND was not a part of the FDA’s questions, solely the third-party elements. We envisioned about compatibility examine shall be wrapped up by the tip of the month.

Along with the scientific maintain work, we proceed to progress with our manufacturing and scientific readiness plans to make sure that as soon as we get hold of IND clearance, we are able to shortly provoke our Section 1 scientific trial. This entails guaranteeing our manufacturing course of meets GMP requirements and the preclinical websites are recognized as a part of the scientific trial, every web site shall be contained a Baxter prismatic system operating software program developed particularly for miroliverELAP.

In abstract, we consider we’re taking all the required steps to submit a radical response to the FDA’s scientific maintain higher within the second-half of this 12 months, and we sit up for with the ability to deal with sufferers with acute liver failure in a Section 1 scientific trial as quickly because the FDA authorization is obtained.

Transferring past, miroliverELAP to our totally implantable bioengineered applications, we proceed to make progress and acquire business recognition for the promise of our totally implantable bioengineered applications. Throughout the second quarter, we represented the cell and gene remedy sector to Capitol Hill policymakers on the Alliance for Regenerative Drugs’s Congressional Fly-In. We offered on the American Transplant Congress, and we had been awarded Finest in Congress for our mirokidney poster.

The Nationwide Kidney Basis invited us to take part of their Innovation Day, highlighting revolutionary options for sufferers with renal failure and the Affiliation of Organ Procurement Organizations invited us to take part of their annual assembly to debate how bioengineered organs could sometime profit transplant sufferers and the way Miromatrix is aligned with AOO.

We additionally had a manuscript revealed in Frontiers and Bioengineering and Biotechnology titled, sustained in vivo perfusion of a re-endothelialized tissue engineered kidney graft in a human-scale animal mannequin that demonstrated how a bioengineered kidney graft might keep patency with constant blood circulate. These outcomes established a foundational platform for our ongoing analysis and so as to add to our rising physique of proof on the potential of utilizing bioengineered kidneys as a substitute for human allograft kidneys.

Amidst all of this exercise, our Medical Director, Dr. Jack Lake was offered a lifetime achievement award by the American Transplant Congress, which actually capped off a busy and rewarding second quarter. So I’d like to increase my congratulations to Dr. Lake for being acknowledged by the transplant neighborhood and a key thought chief within the business. Trying ahead to the remainder of the 12 months, we shall be presenting at ARM’s tissue engineering and therapeutic workshop and ASN’s Kidney Week and eventually, AASLD’s Liver Assembly. These upcoming high-profile occasions ought to sequence nicely with our responses to the FDA from miroliverELAP.

Now I’ll flip the decision over to Jim Douglas, our Chief Monetary Officer, to debate our monetary outcomes.

Jim Douglas

Thanks, Jeff. We completed the second quarter of 2023 with unrestricted money and investments totaling $20.4 million, which we consider is enough to function our enterprise by means of the second quarter of 2024. Moreover, we obtained money funds for $457,000 of the $527,000 worker retention credit score receivable subsequent to the second quarter, and the remaining quantity has been confirmed for upcoming receipt by the IRS.

Transferring to the revenue assertion, working loss was $6.7 million and $14.8 million for the three and 6 month intervals ended June 30, 2023, respectively, as in comparison with $8.2 million and $15.4 million for the three and 6 month intervals ended June 30, 2022, respectively. The lower in working loss for comparable intervals was primarily attributable to decreased analysis and improvement lab provide prices.

Web loss was $6.5 million or $0.24 per share and $14 million or $0.56 per share for the three and 6 months ended June 30, 2023, respectively, as in comparison with $8.2 million or $0.40 per share and $15.4 million or $0.75 per share for the three and 6 months ended June 30, 2022, respectively. The lower in web loss for comparable intervals was primarily attributable to decreased analysis and improvement lab provide prices along with one-time worker retention credit totaling $527,000 that was recorded as different revenue within the first quarter of 2023.

With that, I’ll flip the decision again over to the operator to open the road for questions.

Query-and-Reply Session

Operator

We are going to now start the question-and-answer session. [Operator Instructions] The primary query comes from Alex Nowak with Craig-Hallum. Please go forward.

Alex Nowak

Okay, nice. Good afternoon, everybody. Sounds just like the biocomp examine is wrapping up right here on the finish of the month, the animal examine probably possibly ends in September. These are my very own phrases. So possibly — might you resubmit to the FDA by the tip of September, early October? What are your ideas there?

Jeff Ross

Sure, Alex. As we highlighted within the name, actually pleased with the progress that we made on the 2 sort of lead lengthy poles of the tent that we’ve been engaged on. And as you highlighted, actually excited that the biocomp will wrap up by the tip of this month, completely happy to report that every part that we’ve examined up to now has handed. There weren’t many surprises there, but it surely’s good to get that passing grades on these as nicely. So we’re simply remaining on two extra exams which are scheduled to come back in on the finish of the month.

On the preclinical security facet, as we highlighted, there’s eight animals that make up that whole cohort, excited to report that seven of these are accomplished. We’ve got one check animal to finish, after which that’s able to go off to the pathologist and get the ultimate report to have the ability to submit that. So when you take a look at the timing related to that, definitely aren’t going to supply extra steering on that. I feel our steering remains to be the second-half of this 12 months. However I feel the reassuring factor is that these exams are going nicely and searching ahead to that knowledge coming in, so we are able to submit a really sturdy response to the FDA.

Alex Nowak

That may be very useful, Jeff. Respect it. You realize, almost about the preclinical animal examine, the issue previously was the pig mile that you just needed to depend on, and I feel you needed to engineer a singular pig mannequin for the brand new preclinical examine. Are you able to possibly converse to how that new animal mannequin finally — how did it fare with the seven out of the eight pig up to now? Had been you fairly pleased with these outcomes?

Jeff Ross

Sure, as you highlighted, and we’ve highlighted previously, I imply, our greatest complication was actually arising with a mannequin the place you might ship this life-saving new sort of expertise, however to have the ability to try this, you bought to mobilize the pig for a length of time. And that was actually the problem in our preliminary examine the place we noticed excessive ranges of mortality related to it. So even contained in the management, which is simply being anesthetized, we noticed a fallout within the examine of that. Comfortable to report that preclinical staff right here has completed an exceptional job of actually redesigning that examine and dealing with veterinaries, working with thought leaders to have the ability to provide you with an answer.

And we actually examined that at varied pilot research and proved that out. So we had been capable of roll that out. And as a part of our ongoing, we now have not misplaced any animals previous to the termination of the examine itself when every part is up and operating. We’ve nonetheless had some minor issues related to issues that you just usually see in a preclinical examine like a catheter are available enhance or one thing like that, that’s simply excluded as a part of your cohorts. However when the remedy is definitely being delivered within the new mannequin, it’s been extremely secure, which provides us a variety of confidence to have the ability to spherical out this final check topic and transfer ahead with the info set.

Alex Nowak

Okay, wonderful. Good to listen to. Perhaps converse to the actions that you just’re doing underway on the scientific trial websites and getting transplant facilities and able to carry out the first-in-human examine. Have you ever picked the primary web site but?

Jeff Ross

We’ve got — as we talked about on our final earnings name, the record of exercise related to that, we see a excessive degree of curiosity throughout the scientific neighborhood to be a part of our scientific examine. So we’ve now whittled that record right down to eight, and we’ve prequalified a minimum of 5 scientific websites that might be able to go as soon as we obtain our IND clearance. And prioritizing these out of the gate, we now have eight which are — an extra three which are lined up, able to go as nicely. However we’re actually attempting to guage is what are the scientific websites the place we might be activated as quickly as doable as a result of we all know there’s going to be a variety of pleasure and demand for this remedy as soon as our IND is cleared.

Alex Nowak

Wonderful. Perhaps simply final query. The Lancet final month had a full write-up on the cardiac transplant affected person that occurred a couple of 12 months in the past or so. As you’ve reviewed the case examine there, how does that affect your view round Miromatrix strategy to organ improvement versus the Xenotransplant strategy? And what are you listening to within the business?

Jeff Ross

I feel it nonetheless highlights the significance of the method that we’re endeavor and going ahead with. And I feel it highlights two issues with the bioengineered organ strategy that we’ve highlighted earlier than. And one is as a result of we’ve already commercialized the matrix itself and is a part of our decellularization course of, we get viral clearance. So the facet and the protection facet from the porcine virus standpoint, we really feel we’ve already addressed that.

And the opposite huge unknown and Lancet article seems to be at that in addition to immunosuppression. As we take a look at our remedy within the bioengineered strategy, we’re recellularizing with allogeneic human cells. So we consider that our immunosuppression protocol shall be just like the gold commonplace that’s used at the moment as a part of cadaveric an organ donation at the moment. So I feel it was useful to see spotlight how that case had gone ahead, however a few of the challenges related to that, that I see extra on the expertise facet that must be offered within the xeno facet.

And I feel our bioengineered organ strategy has actually addressed these dangers nicely as we transfer ahead. So once more, that’s why the main focus that we talked about earlier than, the significance of ELAP as our first product after which the read-through to the totally transplantable organ platform is basically our first alternative to begin to display that with a bioengineered organ, which we consider then opens up the chance for our totally transplantable applications to proceed ahead.

Alex Nowak

Completely. Alright, nicely respect the replace. Thanks.

Jeff Ross

Completely. Thanks, Alex.

Operator

The following query comes from Matthew O’Brien with Piper Sandler. Please go forward.

Phillip Dantoin

Hey, that is Phil on for Matt. Thanks for taking our questions. Only one or two for us. The primary one being simply new function, I assume, previous function simply sort of doubled up right here. Are you able to give us your places and takes on sort of stepping again into this function and the way you’re going to sort of double up the CEOs Head of Analysis there, R&D? Thanks.

Jeff Ross

Sure, I respect the query, Phil. That was partially a pure transition. As you might have highlighted earlier than, my background is powerful within the technical facet and got here from the R&D facet. In order we actually began specializing in the place we wanted to go ahead as we concentrate on ELAP, it actually was a pure transition to have the ability to carry that function again in and actually have the ability to focus that, that permits us a variety of focus on the firm. With that stated, issues proceed to go very nicely from that standpoint.

Phillip Dantoin

And my ultimate one simply being, you’ve offered three posters at ATC, Affiliation of Organ Procurement Organizations, et cetera, et cetera. Simply how is curiosity constructing over time? And what are docs saying?

Jeff Ross

Sure. I imply it’s thrilling to go to these conferences and see the thrill across the expertise and begin to open up the chance to consider what the longer term might appear to be with these kinds of organs going ahead. I feel as we take a look at ATC, I feel the neighborhood was definitely, I say, stunned or impressed with the extent and the standard of knowledge that was put forth on the renal facet, not solely displaying the revascularization sustained capacity to perfuse the organ, but in addition a few of the stuff that we’re beginning to present on the protein retention and the filtration impact of the recellularized kidney that we’ve began to launch that knowledge out. So I feel from that standpoint, the neighborhood continues to be impressed and stunned with the progress that we proceed to make.

Phillip Dantoin

Glad to listen to. Thanks, congrats once more on all the method made on the quarter.

Jeff Ross

Thanks quite a bit.

Operator

This concludes our question-and-answer session. The convention has now concluded. Thanks for attending at the moment’s presentation. You could now disconnect.