Miromatrix Medical Inc. ( NASDAQ: MIRO) Q2 2023 Profits Teleconference August 14, 2023 4:30 PM ET
Business Individuals
Max Forgan – Gilmartin Financier Relations
Jeff Ross – President
Jim Douglas – Chief Financial Officer
Teleconference Individuals
Alex Nowak – Craig-Hallum
Phillip Dantoin – Piper Sandler
Operator
Excellent day, and welcome to the Miromatrix Medical, Inc. 2nd Quarter 2023 Profits Teleconference. All individuals’ will remain in listen-only mode. [Operator Instructions] Please note this occasion is being taped.
I would now like to turn the conference over to Max Forgan with Gilmartin Financier Relations. Please proceed.
Max Forgan
Excellent afternoon and thank you for joining us. Earlier today, Miromatrix launched monetary outcomes for the quarter ended June 30, 2023. The release is presently offered on the business’s site at www.miromatrix.com. Jeff Ross, President; and Jim Douglas, Chief Financial Officer, will host this afternoon’s call.
Prior to we begin, I wish to advise everybody that management will be making declarations throughout this call that consist of positive declarations within the significance of federal securities laws, which are made pursuant to the Safe Harbor arrangements of the Personal Securities Lawsuits Reform Act of 1995. Any declarations consisted of in this call that are not declarations of historic truth, consisting of declarations concerning the prospective timing of pre-IND and IND filings, and the initiation of associated medical trials, future expenditures and earnings, capital requirements, money runway and requires for extra funding needs to be considered to be positive declarations. All positive declarations are based upon present price quotes and numerous presumptions. These declarations include material dangers and unpredictabilities that might trigger real outcomes to vary materially from those expected or indicated by these positive declarations.
Appropriately, you must not position unnecessary dependence on these declarations. For a list and descriptions of the product dangers and unpredictabilities related to our service, please see our filings with Securities and Exchange Commission. The details offered in this teleconference speaks just to the live broadcast today, August 14, 2023. Miromatrix disclaims any objective or responsibility, other than as needed by law, to upgrade or modify any details, monetary forecasts or other positive declarations, whether due to the fact that of brand-new details, future occasions or otherwise.
With that, I will now turn the call over to Jeff.
Jeff Ross
Thanks, Max. Excellent afternoon, and thank you, everybody, who has actually joined us for today’s revenues call. We continue to make substantial development on resolving the products recognized within the FDA medical hold letter, connecting to our miroliverELAP IND submission. Our objective stays to send a complete reaction to the FDA in the second-half of 2023, and we picture getting permission to deal with clients with intense liver failure soon afterwards.
As a tip, we are focusing on miroliverELAP in the near-term, due to the fact that our company believe it supplies us with the fastest course to dealing with organ failure clients with our bioengineered organs. Which program supplies us with important insight to our completely implantable bioengineered organ programs.
As I regularly pointed out, we might choose to invest more greatly into any of our completely implantable organ programs, if a collaboration develops or situations modification. Particular to miroliverELAP, you might remember a number of longer lead products that we are resolving as part of the medical hold associated to a preclinical animal research study and biocompatibility research study.
I enjoy to report that we began both research studies throughout the 2nd quarter and are nearing conclusion for the in-life part of the animal research study and the biocompatibility research study. As a tip, the animal security research study has 2 arms including 8 animals in each, 4 deals with and 4 controls. This security research study is smaller sized than our initial security research study that was sent as part of the IND bundle.
In our initial animal security research study, there was no proof of systemic toxicity in the miroliverELAP group or the control group. Nevertheless, there was significant death in all groups due to the immobilization strategies and the anesthesia needed to supply treatment in a pig design, that makes longer treatments in a set in motion animal design challenging. The present security research study made use of and enhanced the mobilization strategies and anesthesia to lower death in all animals. We are presently collecting all the information connecting to this research study to include into our reaction to the FDA.
Relating to the biocompatibility research study, the FDA asked for that we do extra screening concerning the last completed fluid course consisted of third-party parts. The biocompatibility screening we sent on our liver graft as part of the IND was not part of the FDA’s concerns, just the third-party parts. We visualized about compatibility research study will be concluded by the end of the month.
In addition to the medical hold work, we continue to advance with our production and medical preparedness strategies to guarantee that as soon as we acquire IND clearance, we can rapidly start our Stage 1 medical trial. This includes guaranteeing our production procedure fulfills GMP requirements and the preclinical websites are recognized as part of the medical trial, each website will be consisted of a Baxter prismatic system running software application established particularly for miroliverELAP.
In summary, our company believe we are taking all the required actions to send a comprehensive reaction to the FDA’s medical hold much better in the second-half of this year, and we anticipate having the ability to deal with clients with intense liver failure in a Stage 1 medical trial as quickly as the FDA permission is gotten.
Moving beyond, miroliverELAP to our completely implantable bioengineered programs, we continue to make development and gain market acknowledgment for the pledge of our completely implantable bioengineered programs. Throughout the 2nd quarter, we represented the cell and gene treatment sector to Capitol Hill policymakers at the Alliance for Regenerative Medication’s Congressional Fly-In. We provided at the American Transplant Congress, and we were granted Finest in Congress for our mirokidney poster.
The National Kidney Structure welcomed us to take part in their Development Day, highlighting ingenious options for clients with kidney failure and the Association of Organ Procurement Organizations welcomed us to take part in their yearly conference to go over how bioengineered organs might one day benefit transplant clients and how Miromatrix is lined up with AOO.
We likewise had actually a manuscript released in Frontiers and Bioengineering and Biotechnology entitled, sustained in vivo perfusion of a re-endothelialized tissue crafted kidney graft in a human-scale animal design that showed how a bioengineered kidney graft might keep patency with constant blood circulation. Those outcomes developed a fundamental platform for our continuous research study and to contribute to our growing body of proof on the capacity of utilizing bioengineered kidneys as an option to human allograft kidneys.
In The Middle Of all of this activity, our Medical Director, Dr. Jack Lake existed a life time accomplishment award by the American Transplant Congress, which truly topped off a hectic and gratifying 2nd quarter. So I want to extend my congratulations to Dr. Lake for being acknowledged by the transplant neighborhood and an essential idea leader in the market. Anticipating the remainder of the year, we will exist at ARM’s tissue engineering and restorative workshop and ASN’s Kidney Week and lastly, AASLD’s Liver Satisfying. These upcoming prominent occasions must series well with our actions to the FDA from miroliverELAP.
Now I will turn the call over to Jim Douglas, our Chief Financial Officer, to discuss our monetary outcomes.
Jim Douglas
Thank you, Jeff. We completed the 2nd quarter of 2023 with unlimited money and financial investments amounting to $20.4 million, which our company believe suffices to run our service through the 2nd quarter of 2024. In addition, we got money payments for $457,000 of the $527,000 staff member retention credit receivable subsequent to the 2nd quarter, and the staying quantity has actually been verified for upcoming invoice by the internal revenue service.
Relocating to the earnings declaration, running loss was $6.7 million and $14.8 million for the 3 and 6 month durations ended June 30, 2023, respectively, as compared to $8.2 million and $15.4 million for the 3 and 6 month durations ended June 30, 2022, respectively. The reduction in running loss for similar durations was mostly attributable to reduced research study and advancement laboratory supply expenses.
Bottom line was $6.5 million or $0.24 per share and $14 million or $0.56 per share for the 3 and 6 months ended June 30, 2023, respectively, as compared to $8.2 million or $0.40 per share and $15.4 million or $0.75 per share for the 3 and 6 months ended June 30, 2022, respectively. The reduction in bottom line for similar durations was mostly attributable to reduced research study and advancement laboratory supply expenses in addition to one-time staff member retention credits amounting to $527,000 that was taped as other earnings in the very first quarter of 2023.
With that, I will turn the call back over to the operator to open the line for concerns.
Question-and-Answer Session
Operator
We will now start the question-and-answer session. [Operator Instructions] The very first concern originates from Alex Nowak with Craig-Hallum. Please proceed.
Alex Nowak
Okay, excellent. Excellent afternoon, everybody. Seems like the biocomp research study is finishing up here at the end of the month, the animal research study possibly perhaps ends in September. Those are my own words. So perhaps– could you resubmit to the FDA by the end of September, early October? What are your ideas there?
Jeff Ross
Yes, Alex. As we highlighted in the call, truly pleased with the development that we made on the 2 type of lead long poles of the camping tent that we have actually been dealing with. And as you highlighted, truly delighted that the biocomp will finish up by the end of this month, pleased to report that whatever that we have actually checked up until now has actually passed. There weren’t numerous surprises there, however it’s excellent to get that passing grades on those too. So we’re simply staying on 2 extra tests that are set up to come in at the end of the month.
On the preclinical security side, as we highlighted, there’s 8 animals that comprise that overall friend, delighted to report that 7 of those are finished. We have one test animal to finish, and after that that’s prepared to go off to the pathologist and get the last report to be able to send that. So if you take a look at the timing related to that, definitely aren’t going to supply extra assistance on that. I believe our assistance is still the second-half of this year. However I believe the encouraging thing is that those tests are working out and anticipating that information being available in, so we can send a really strong reaction to the FDA.
Alex Nowak
That is extremely handy, Jeff. Value it. You understand, with concerns to the preclinical animal research study, the issue in the past was the pig mile that you needed to trust, and I believe you needed to craft a special pig design for the brand-new preclinical research study. Can you perhaps talk to how that brand-new animal design eventually– how did it fare with the 7 out of the 8 pig up until now? Were you quite pleased with those outcomes?
Jeff Ross
Yes, as you highlighted, and we have actually highlighted in the past, I imply, our most significant problem was truly creating a design where you might provide this life-saving brand-new kind of innovation, however to be able to do that, you got to set in motion the pig for a period of time. Which was truly the difficulty in our preliminary research study where we saw high levels of death related to it. So even inside the control, which is simply being anesthetized, we saw a fallout in the research study of that. Delighted to report that preclinical group here has actually done an extraordinary task of truly upgrading that research study and dealing with veterinaries, dealing with idea leaders to be able to come up with an option.
And we truly checked that at numerous pilot research studies and showed that out. So we had the ability to roll that out. And as part of our continuous, we have actually not lost any animals prior to the termination of the research study itself when whatever is up and running. We have actually still had some small issues related to things that you typically see in a preclinical research study like a catheter been available in increase or something like that, that is quickly left out as part of your accomplices. However when the treatment is in fact being provided in the brand-new design, it’s been exceptionally steady, which offers us a great deal of self-confidence to be able to complete this last guinea pig and progress with the information set.
Alex Nowak
Okay, outstanding. Excellent to hear. Possibly talk to the activities that you’re doing underway on the medical trial websites and getting transplant centers interested and prepared to carry out the first-in-human research study. Have you chose the very first website yet?
Jeff Ross
We have– as we discussed on our last revenues call, the list of activity related to that, we see a high level of interest within the medical neighborhood to be part of our medical research study. So we have actually now whittled that note down to 8, and we have actually prequalified a minimum of 5 medical websites that would be prepared to go as soon as we get our IND clearance. And focusing on those out of eviction, we have 8 that are– an extra 3 that are lined up, prepared to go as well. However we’re truly attempting to assess is what are the medical websites where we can be triggered as quickly as possible due to the fact that we understand there’s going to be a great deal of enjoyment and need for this treatment as soon as our IND is cleared.
Alex Nowak
Outstanding. Possibly simply last concern. The Lancet last month had a complete review on the heart transplant client that took place about a year ago approximately. As you’ve examined the case research study there, how does that impact your view around Miromatrix technique to organ advancement versus the Xenotransplant technique? And what are you hearing in the market?
Jeff Ross
I believe it still highlights the value of the procedure that we’re carrying out and moving forward with. And I believe it highlights 2 things with the bioengineered organ technique that we have actually highlighted prior to. And one is due to the fact that we have actually currently advertised the matrix itself and becomes part of our decellularization procedure, we get viral clearance. So the side and the security side from the porcine infection perspective, we feel we have actually currently resolved that.
And the other huge unidentified and Lancet short article takes a look at that in addition to immunosuppression. As we take a look at our treatment in the bioengineered technique, we’re recellularizing with allogeneic human cells. So our company believe that our immunosuppression procedure will resemble the gold requirement that’s utilized today as part of cadaveric an organ contribution today. So I believe it was handy to see emphasize how that case had actually moved forward, however a few of the difficulties related to that, that I see more on the innovation side that requires to be offered in the xeno side.
And I believe our bioengineered organ technique has actually truly resolved those dangers well as we progress. So once again, that’s why the focus that we discussed previously, the value of ELAP as our very first item and after that the read-through to the completely transplantable organ platform is truly our very first chance to begin to show that with a bioengineered organ, which our company believe then opens the chance for our completely transplantable programs to continue forward.
Alex Nowak
Definitely. Alright, well value the upgrade. Thank you.
Jeff Ross
Definitely. Thanks, Alex.
Operator
The next concern originates from Matthew O’Brien with Piper Sandler. Please proceed.
Phillip Dantoin
Hey, this is Phil on for Matt. Thanks for taking our concerns. Simply a couple of for us. The very first one being simply brand-new function, I think, old function simply type of doubled up here. Can you provide us your puts and handles type of going back into this function and how you’re going to type of double up the CEOs Head of Research Study there, R&D? Thank you.
Jeff Ross
Yes, I value the concern, Phil. That was partly a natural shift. As you have actually highlighted previously, my background is strong in the technical side and originated from the R&D side. So as we truly began concentrating on where we required to move forward as we concentrate on ELAP, it truly was a natural shift to be able to bring that function back in and truly have the ability to focus that, that enables us a great deal of focus at the business. With that stated, things continue to go extremely well from that perspective.
Phillip Dantoin
And my last one simply being, you have actually provided 3 posters at ATC, Association of Organ Procurement Organizations, et cetera, et cetera. Simply how is interest structure in time? And what are docs stating?
Jeff Ross
Yes. I imply it’s interesting to go to those conferences and see the enjoyment around the innovation and begin to open the chance to think of what the future might appear like with these kinds of organs moving forward. I believe as we take a look at ATC, I believe the neighborhood was definitely, I state, stunned or amazed with the level and the quality of information that was presented on the kidney side, not just revealing the revascularization sustained capability to perfuse the organ, however likewise a few of the things that we’re beginning to reveal on the protein retention and the filtering result of the recellularized kidney that we have actually begun to launch that information out. So I believe from that perspective, the neighborhood continues to be amazed and stunned with the development that we continue to make.
Phillip Dantoin
Happy to hear. Thanks, congrats once again on all the procedure made on the quarter.
Jeff Ross
Thanks a lot.
Operator
This concludes our question-and-answer session. The conference has actually now concluded. Thank you for going to today’s discussion. You might now detach.