Q2 2023 Miromatrix Medical Inc Earnings Call

$15 $4 million or <unk> 75 cents per share for the three and six months ended June 32022, respectively.

The decrease in net loss for comparable periods was primarily attributable to decreased research and development lab supply costs.

And to one time employee retention credits totaling $527000 that was recorded as other income in the first quarter of 2023.

With that I will turn the call back over to the operator to open the line for questions.

We will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone, if you're using a speakerphone. Please pick up your handset before pressing the keys. If at any time. Your question has been addressed and you would like to withdraw your question. Please press Star then two.

At this time, we will pause momentarily to assemble our roster.

The first question comes from Alex Nowak with Craig Hallum. Please go ahead.

Okay, great. Good afternoon, everyone sounds like the Bicarb study is wrapping up here at the end of the month the animal study.

Maybe ends in September those are my own words, so maybe if you could you resubmit to the FDA by the end of September early October what are your thoughts there.

Yeah, Alex Thanks for the question is as we highlighted in the call I'm really happy with the progress that we've made on the two kind of lead long poles in the tent that we've been working on.

And as you highlighted really excited that the bio comp will wrap up by the end of this month happy to report that everything that we've tested so far has passed its important many surprises there, but its going to get that passing grades on those as well. So we're just remaining two additional tests that are scheduled to come in at the end of the month.

On the preclinical safety side as we highlighted there's eight animals that make up that total a cohort.

I'm excited to report that set many of those are completed we have won one test animals to complete and then that's ready to go out to the pathologists and get the final report to be able to submit that so if you look at the timing associated with that certainly aren't going to provide additional guidance on that I think our guidance is still the second half of this year.

But I think the reassuring thing is that those tests are going well and looking forward to that data come in so we can we can submit a very strong response to the FDA.

That was very helpful. Jeff I appreciate it you know with regards to the preclinical animal study.

The problem in the past was the pig models that you had to rely upon and I think you had an engineer.

Pig model.

For the for the New preclinical study can you maybe speak to how that new animal model ultimately.

How did how did it fare with seven out of the AP. So far where are you pretty happy with those results.

Yeah as you highlighted and we've highlighted in the past I mean, our biggest complication was really coming up with a bottle where you could deliver you know this life saving new type of technology, but to be able to do that you've got a mobilized the pig for a duration of time, but that was really the challenge in our initial study where we saw high levels.

Oh mortality associated with it so even tried to control, which is just being anesthetized. We saw fallout in the study of that happy to report that preclinical team here has done a phenomenal job of really redesigning that studying working with veterinarians working with thought leaders to be able to come up with the solution and we really tested that.

Various pilot studies and prove that out so we were able to roll that out and as part of our ongoing we have not lost any animals prior to the termination.

Well the study itself when.

When everything is up and running we still had some minor complications.

Associated with.

Things that you'd normally see in a preclinical study like a catheter.

Come in booths or something like that that is going to be excluded as part of your cohorts, but when the therapy is actually being delivered in the new model. It's been incredibly stable, which gives us a lot of confidence to be able to build out this last test subject and move forward with the dataset.

Okay excellent and that's good to hear maybe speak to the activities that you're doing under way on the clinical trial sites in and getting transplant centers.

Interested in and ready to perform the first in human study, how do you pick the first site yet.

We have as we talked about on our last earnings call. You know the list of activity associated with that we see high level of interest.

In the clinical community to be part of our clinical studies. So we've now whittled that list down to eight.

And we've prequalified at least five clinical sites that would be ready to go once we receive our I N D Clarence and in.

Prioritizing those out of the gate, we have eight that are all you know an additional three that are lined up ready to go as well, but we're really trying to evaluate is what are their clinical sites, where we.

We can be activated as soon as possible because we know there's going to be a lot of excitement and demand for this therapy.

Once our idea is cleared.

Excellent maybe just last question the lancet last month had a full write up on the cardiac transplantation that happened about a year ago or so.

You know as you've reviewed the case study there you know how does that influence your view around mirror matrix approach to Orca development versus the transplant approach what are you hearing in the industry.

Yeah, but I think it's still highlights.

The importance of the process that we're undertaking and going forward with and I think it highlights two things with the bioengineered organ approach that we've highlighted before and one is because we've already commercialized the matrix itself and as part of our deceleration process, we get viral clearance so the side and safety side from the front.

The porcine virus standpoint, we feel we've already addressed that and the other big unknown in lancet article looks at that as well as immuno suppression as we look at our therapy in the bio engineered approach, where reseller rising with allogeneic, who themselves. So we believe that our immuno suppression protocol will be similar to that.

Gold standard that's used today as part of Cat of Eric and Oregon donation today. So I think it was helpful to see you know highlight how that case had gone forward, but some of the challenges associated with that that I see more on the technology side that needs to be solved and as you know side and I think our bioengineered organ approach is really addressed those.

Risks well as we move forward. So it you know again, that's why the focus that we talked about before the importance of <unk> is our first product and then the read through to the fully Transplantable, Oregon platform is it's really our first opportunity to start to demonstrate that with a bioengineered organs, which we believed then opens up the opportunity.

For our fully transplantable programs to continue forward.

Absolutely alright, well I appreciate the update thank you.

Absolutely Thanks, Alex.

The next question comes from Matthew O'brien with Piper Sandler. Please go ahead.

Hey, this is Phil on for Matt. Thanks for taking my questions, just one or two for US. The first one being just new role I guess old role I'm, just kind of doubled up here can you give us your puts and takes on you know kind of stepping back into this role and how youre going to kind of double up the Ceos head of us.

Research there are indeed, thank you.

Yeah I appreciate the question Phil.

It was partially a natural transition as you as you have highlighted before my background is strong and the technical side and it came from the R&D side. So as we really started focusing on where we needed to go forward.

As we focus on E wrap it really was a natural transition to be able to bring that roll back in and really be able to focus that that allows us a lot of focus at the company with that said.

Things continue to go very well from that standpoint.

It makes sense and my final one just being you know you've presented three posters at a T C.

Association of organ procurement organizations et cetera, et cetera, just how was interest building over time and what our docs, saying.

Yeah, I mean, it's exciting to go to those conferences and see the excitement around around the technology and start to open up the opportunity do you think about what the future could look like with these types of Oregon's going forward I think as we look at a T. C. I think the community was.

Certainly I'd say surprise are impressed with the level and the quality of data that was put forth on the renal side not only showing that revascularization sustained.

Ability to profusely, Oregon, but also some of the stuff that we're starting to show on the.

Protein retention and the filtration effective there'd be televised kidney that debt.

We've started to release that data out so I think from that standpoint that community continues to be a impressed and surprised with the progress that we continue to bank.

Glad to hear it and congrats again on all the progress made in the quarter.

Thanks, a lot.

Okay.

This concludes our question and answer session.

The conference has now concluded. Thank you for attending today's presentation you may now disconnect.