Miromatrix Medical Inc (MIRO) 2023 Q1 法說會逐字稿

Greetings and welcome to the Miromatrix Medical Inc. first quarter 2023 earnings conference call. (operator instructions) As a reminder this conference is being recorded. It's 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, Miromatrix released financial results for the quarter ended March 31, 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 will 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 call. During our fourth year 2022 earnings call, I communicated that we are focusing the majority of our resources on miroliverELAP in the near term to address the items identified in 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 gain 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 Power comprised of third party components. The biocompatibility testing we submitted on our liver graft as part of the IND was now 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 6 animals, 3 to be treated with miroliverELAP and three controls. This is smaller than our original safety study.

In the original animal safety study, there was no evidence of systemic toxicity in the miroliverELAP or the control group. However, there was substantial morbidity in all groups due to the mobilization and anesthesia required to provide therapy in a big model, which makes longer therapies in a mobilized animal model challenging. The new protocol will use improved anesthesia and in mobilization 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 1 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 each of that. Each site will be consigned a Baxter PrisMax system running the software developed specifically for miroliverELAP. 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 from miroliverELAP, 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 miroliverELAP 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 miroliverELAP, it's important for media reiterate, that we remain very enthusiastic about our fully implantable bioengineered organ programs. While we are progressing these programs at a slower pace until miroliverELAP that gains IND clearance, we could reinvigorate any of them if the appropriate partnership revises our circumstances otherwise change.

A recent example highlighting our fully implantable bioengineered organ programs is our partnership with CareDx to develop novel testing solutions to assess organ rejection via a simple blood test. We are honored to be working with CareDx, 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 interactions that I had earlier this month at the annual cell and gene meeting on the MED in Barcelona, Spain and I was asked a moderated 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 past weren't always easy.

All of the Company dealt with challenging setbacks and notably, four of them were placed on clinical hold prior to treat their first patient, to their credit they all stayed at course and delivered medical advertisements 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.

Thank you, Jeff. We finished the first quarter with unrestricted cash and investments totaling $25.6 million. With the prioritization of miroliverELAP occurring at the end of the first quarter spending will be reduced going forward, and we believe we will have sufficient cash to operate our business through the second quarter of 2024.

Moving to the income statement.

Operating loss for the first quarter of 2023 was $8.1 million compared to $7.2 million in the first quarter of 2022. The increase in operating loss for comparable periods was primarily attributable to increased payroll costs and the write-off of previously capitalized deferred option costs.

Net loss for the first quarter of 2023 was $7.5 million or $0.33 per share compared to $7.2 million or $0.35 per share in the first quarter of 2022. The increase in net loss for comparable periods was primarily attributable to increased payroll costs and a write-off of deferred offering costs, offset by a one-time employee retention credit totaling $0.5 million.

In closing, we look forward to presenting at the Craig-Hallum Investor Conference later this month. And with that, I will turn the call back over to the operator to open up the line for. Thank you.

Thank you.

We will now be conducting a question and answer session. (Operator instructions)

Our first question comes from Alex Nowak of Craig-Hallum Capital Group. Please proceed with your question.

Okay, great. Good afternoon, everyone. The preclinical safety study with the six pigs, I just wanted some clarity around that. Did you say that you already ran this study in the six pigs and ran into the morbidity issues with the anesthesia or that you and that you need to re-run it again, just clarity around what was happening there?

Sure, Alex, this is Jeff. Thanks for the question on that. That was clarity around our original submitted safety study that we had previously submitted. So it's reported that there was no systemic toxicity that was reported in that study. However, as we've described before, we saw morbidity associated with the longer anesthesia time associated with that. So and we've addressed those concerns and looking at those improvements in the safety study that I talked about, that will be kicking off shortly.

Okay. Got it. That is helpful. The morbidity that you saw in the original studies. And was that something that was specifically called out by the FDA? And what the company do essentially address that or is there something you're doing on more of an adequate basis?

No, I mean it was, but it's kind of all-encompassing in the fact that when you see the morbidity in some of the control animals, right animals that are only CNA anesthesia still continue to see no systemic toxicity in that or the treated group. With that, sometimes you can have that challenge to beat endpoint or other confronting things that may go on inside of that model due to that longer anesthesia time. So just clearing up that model to reducing that morbidity to further reinforce our data said.

Okay. I understood as you're as to run this test, but you're also running the biocompatibility studies beyond that those take time to get those set up and scheduled. But as you're going through there, is there anything that's jumping out that's making you maybe say, okay, maybe this is going to take another month longer than we were originally thinking or hey, we might need to run an additional study that we didn't originally plan for. Just any thoughts as you're going real time through this process?

Yeah. I think with that, I mean, we work really close with with our strategic partner on this with Baxter as well to be able to look through what that biocomplian looks like because again, the vast majority of these are third party component, and it's more of just having that complete system of the third party component not that there's any issue with any individual component on. So I think we've got a really good plan and you know, now it's on execution of that and ensuring that we can keep all those timelines. I think what you pointed out there and that we're staying very close to is that once these things are shipped off to third parties for the bio comp, we're really dependent on them of holding their timelines throughout that process. But these are professional agencies that do this all the time. So we're staying very close to this. We're monitoring this closely and looking forward to have the data so we can submit it.

And once you do get the data back from the third parties, how quickly can you turn around a response of the FDA?

Very quick on the matter of weeks once you get those because once those reports come back in, these are reports that the FDA and agencies and others see a lot because they're from trusted testing facilities that have the summary of the tests and it has the results on the bottom saying that it passes and the other requirements associated with it. So it's really putting then uploading that into the package. And then it's describing what tests were done and what those results mean. So it doesn't take a long time. The longest time is getting the certified results because these are GLP studies that require a lot of oversight and documentation on the testing facility side.

And,; then just last question on your activities to prepare these trial sites that you've identified, you've reached out to and talk to them to get them ready for once a day once the clearance is given here by the FDA to move forward with the clinical study, just kind of work you're doing right now with them with whether it's regards to training or maybe even more paperwork. I know there are limits to what they can sign off on that until it does reach the IND stage. But then you just kind of speak to the pretrial activities

Sure. I mean, a lot of it's the protocol, protocol sign-off on getting the site to understand the logistics associated with the clinical trial contract. A lot of that stuff gets baked in. And we're looking at that today, placement of the equipment,;; a lot of those aspects go into this. So then once we get the clearance, we'd be able to then quickly do the submission for the IRB. And then once we are cleared on the IRB, we'd be able to move forward with enrolling the first patients. So a lot of good activity that we're front loading, Alex, that normally may take place in parallel or after we're looking at any of those activities that we can do upfront and those are the activities we're doing.

Okay, excellent. That's sounds good. I appreciate the update. Thank you.

Absolutely.

We have reached the end of our question and answer session.

I would now like to, this concludes today's conference. Thank you for your participation. You may disconnect your lines at this time.