Q3 2022 Miromatrix Medical Inc Earnings Call
Operator: Greetings and welcome to the Miromatrix Medical Inc. third quarter 2022 earnings conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star and then zero on your telephone keypad. As a reminder, this conference is being recorded.
At this time all participants are in a listen only mode a brief.
Question and answer session will follow the formal presentation.
If anyone should require operator assistance during the conference. Please press Star and then zero on your telephone keypad.
As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host Hannah Geoffrey. Thank you. Please go ahead.
Hannah Geoffrey: Good afternoon, and thank you for joining us. Earlier today, Miromatrix released financial results for the quarter and nine months ended September 30th, 2022. 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.
<unk> is currently available on the company's website at Www Dot Neurometrics dotcom.
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 meeting of Federal Securities laws, which are made pursuant to the Safe Harbor Provision of the Private Securities Litigation Reform Act of 1995.
They are made pursuant to the safe Harbor provision.
Provision 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 filing and IND clearances, 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.
Mission 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 description of material risks and uncertainties associated with our business, please see our filings with the Securities and Exchange Commission.
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 description of materials and risks 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 14th, 2022. Miromatrix disclaims any intention or obligation except as required by law, 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.
Miro matrix disclaims any intention or obligation except as required by law.
Date, 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.
Jeff Ross: Thanks, Hannah. Good afternoon, and thank you everyone who has joined us today for our third quarter 2022 earnings call. I am proud to announce what many have been waiting to hear. We recently filed our IND application for [inaudible] with the FDA. We are pioneering a new class of medicine and believe that this is the first IND to be submitted to the FDA for a bioengineered organ, putting us one step closer to realizing our goal of saving and improving patients' lives and eliminating the organ transplant waiting list. We will wait for the FDA's feedback and plan to initiate a phase one clinical trial shortly after receiving their clearance. I'm incredibly proud of our entire team for achieving this important milestone.
Rob would you announce what many had been waiting for a year. We recently filed our IND application for Bureau, liberate U S. With the FDA. We are pioneering a new class of medicine and believe that this is the first <unk> to be submitted to the FDA for a bioengineered, Oregon.
Putting us one step closer to realizing our goal of saving and improving patients' lives and eliminating the organ transplant waiting list.
We will wait for the Fda's feedback and plan to initiate a phase one clinical trial shortly after receiving their clearance I'm incredibly proud of our entire team for achieving this important milestone.
Before I provide additional updates on our three programs in development, I'd like to quickly remind everyone about our technology platform and a few key points of differentiation. So very quickly, Miromatrix bioengineered organs for human transplant utilizing our proprietary two-step deceleration and deceleration technology platform, which is applicable to all organs. Our initial focus is on bioengineering livers, and kidneys, which account for nearly 95% of the organ transplant waiting list. We own all of the core IP around perfusion deceleration and recellularization technology, which has an important point of differentiation versus alternative technologies, such as gene editing, which fall under the umbrella of xenotransplantation. Xenotransplantation is characterized by the presence of living animal cells in the products. These living animal cells have been the source of some key challenges facing xenotransplantation, notably pig virus transmission and organ rejection.
So very quickly Bureau matrix bioengineered organs for human transplant utilizing our proprietary two step deceleration at reseller they should technology platform.
Which is applicable to all Oregon's.
Our initial focus is on bioengineering, livers, and kidneys, which account for nearly 95% of the Oregon transplant waiting list.
All of the core IP around perfusion deceleration and reseller <unk> technology.
Which has an important points of differentiation versus alternative technologies, such as gene editing, which fall under the umbrella of transplantation.
Xenotransplantation is characterized by the presence of living animal cells in the products. These living animal cells have been the source of some key challenges facing xenotransplantation, notably pig virus transmission and organ rejection.
Notably pig virus transmission and Oregon rejection.
We believe that our bioengineered organs will not be regulated as xenotransplantation because a deceleration step is designed to remove the living animal cells from the organ. We have also demonstrated the required viral and activation steps to reduce the risk of any pig virus transmission.
We have also demonstrated that required viral and activation steps to reduce the risk of any pig virus transmission.
The second step, recellularization, repopulates the decellularized matrix with human cells, and therefore, we believe our bioengineered organs will possess a rejection profile similar to human-to-human organ transplant.
Finally, it is easy to visualize the operational efficiencies such as supply chain and cost of goods that our technology enables. Hopefully, that gives everyone a good refresher of our technology and a few key points of differentiation. Now I'll provide status updates on our three programs in development: miroliverELAP, miroliver, and mirokidney.
Hopefully that gives everyone a good refresher of our technology and a few key points of differentiation.
Now I'll provide status updates on our three programs in development: Miro Liver [inaudible], Miro Liver, and Miro Kidney.
As I mentioned at the beginning of the call, we recently achieved a major milestone and filed our IND application for miroliverELAP. We plan to initiate a phase one clinical trial shortly after receiving IND clearance from the FDA.
I would like to extend personal gratitude to John Barry, Mason Mckenzie, Peggy Norris, Joel Britain, and Chris [inaudible] and the members of their teams for achieving this important milestone. I know how hard they've all worked to accomplish this goal. Thank you all, and congratulations.
The members of their teams for achieving this important milestone.
I know how hard they've all work to accomplish this goal. Thank you all and congratulations.
MiroliverELAP is our external liver assist product that we developed to treat patients suffering from acute liver failure or ALF. The liver is the only organ in the body that can regenerate itself and miroliverELAP is designed to help in that process. Think of miroliverELAP as liver dialysis, where a patient's blood is circulated through one of our bioengineered livers that can reside bedside in a chamber connected to a continuous renal replacement therapy system, our CRRT.
Deliver isn't the only Oregon in the body that can regenerate itself and Merrell liver <unk> is designed to help in that process.
Think of Miro liver elapsed as liver dialysis, where a patient's blood is circulated through one of our bioengineered livers that can reside bedside in a chamber connected to a continuous renal replacement therapy system our CRT.
Over the course of treatment, the patient's blood is continuously filtered and returned to the patient through the closed loop circuit, so the native liver can be offloaded to provide critical time to receive a lifesaving liver transplant or allow their native liver to hopefully recover itself back to health.
The CRRT system that will be utilized in our clinical trial have been designed with software updates to accommodate our bioengineered livers and to facilitate liver dialysis. The current generation of these systems is available in most ICUs and are designed to deliver continuous renal replacement therapy and therapeutic plasma exchange. Our modified CRRT systems were created specifically for our study, and if this study is ultimately successful and miroliverELAP gains approval, the existing installed base of CRRT systems can receive similar software updates to accommodate miroliverELAP and enable the delivery of liver dialysis.
Current generation of these systems is available in most IC use and are designed to deliver continuous renal replacement therapy and therapeutic plasma exchange <unk>.
Our modified Ciara our T systems.
Were created specifically for our study and if this study is ultimately successful in miro liver <unk> gains approval the existing installed base of <unk> systems can receive similar software updates to accommodate bureau, liver, new lab and enable the delivery of liver dialysis.
Our liver support, our dialysis has some important differences versus kidney dialysis that I want to highlight. First, liver dialysis is an acute therapy performed once in the ICU, whereas kidney dialysis is a chronic therapy performed indefinitely in an outpatient center or at home. Again, this is because the liver is the only organ capable of regenerating itself.
Again this is because the liver is the only Oregon capable of regenerating itself.
To perform a miroliverELAP procedure, one of our bioengineered livers will be delivered to the ICU from our fully integrated manufacturing facility in case in a disposable chamber and connected to our CRRT device situated near the patient's bedside. We currently envision utilizing one bioengineered liver per treatment. If successful, at a minimum, this would serve as a bridge to transplant, and at a maximum, this could serve as a bridge to recovery where it would not only benefit the the treated patient, it could also free up livers for others in need of transplants because today, over 50% of ALS patients either die or receive a liver transplant.
<unk> one of our bioengineered livers will be delivered to the ICU from our fully integrated manufacturing facility in case in a disposable chamber and connected to our CRT device situated near the patient's bedside. We currently envision utilizing one bio engineered liver per treatment if six.
First of all at a minimum this would serve as a bridge to transplant and at a maximum this could serve as a bridge to recovery, where it would not only benefit the.
the treated patient, it could also free up livers for others in need of transplants because today, over 50% of ALS patients either die or receive a liver transplant.
The impact of miroliverELAP on the health system could be substantial as 50,000 people in the US die every year from all types of liver failure. And in a typical year, only about 9,000 liver transplants are performed due to the lack of supply. Specific to the addressable market for miroliverELAP, approximately 80,000 people are hospitalized each year due to a combination of ALS, acute chronic liver failure, and alcoholic hepatitis. We expect that the initial addressable market for our miroliverELAP product candidate will be the ALS population, which represents up to 5,000 or the 80,000 hospitalizations I just referenced.
Pacific to the addressable market for Merrell liver you lap approximately 80000 people are hospitalized each year due to a combination of AOS acute on chronic liver failure and alcoholic hepatitis, we expect that the initial addressable market for our miro liver <unk> product candidate.
We'll be the AOS population, which represents up to 5000 or 80000 hospitalizations I just referenced.
While expansion studies would likely be required to address the additional patient population, I want to make sure that people appreciate the potential total addressable market that we can envision from miroliverELAP.
Today, there is no gold standard therapy for ALS, and supportive and symptomatic management are the cornerstones of current treatment. [inaudible] medicine overdose is the most common cause of ALS in the United States and there is an effective antidote available that is most effective given within eight hours of overdose.
Theta Madison overdose is the most common cause of ALS in the United States and there is an effective antidote available that is most effective given within eight hours of overdose.
Other common causes of ALS are mushroom overdose and viral hepatitis, and treatments often include a cocktail of therapies. As you can appreciate from these examples, without a standard of care there is significant potential for missing a therapeutic window or lack of a viable therapy. Importantly, miroliverELAP can be used in combination with other therapies than an ALS patient may be prescribed.
Importantly, miroliverELAP can be used in combination with other therapies than an ALS patient may be prescribed.
The current design of our phase one trial for miroliverELAP envisions enrolling up to 15 ALS patients. These patients can be on treatment for up to three days and monitored for 21 days thereafter. Our plan is to enroll patients at up to six clinical sites, and we have a good sense of which institutions will likely participate in our phase one clinical trial. Participating sites will become known after our IND is cleared by the FDA, at which time, institutions can begin their internal IRB process.
These patients can be on treatment for up to three days and monitored for 21 days thereafter, our plan is to enroll patients at up to six clinical sites and we have a good sense of which institutions will likely participate in our phase one clinical trial participating sites will become known after our IND is cleared by the.
FDA at which time institutions can begin their internal IRB process.
The manageable size of this trial and a fast follow-up leads us to believe that we could have phase one data in hand within nine to 12 months of commencing the trial. If successful, we foresee commencing phase II and phase III clinical trials, potentially a combined phase II phase III trial soon thereafter.
<unk> is a combined phase II phase III trial soon thereafter.
We are actively exploring various regulatory and marketing pathways that may be applicable to miroliverELAP. We anticipate seeking an RMAT designation that would allow us to receive greater interactions with the FDA during development and a priority review designation upon BLA submission. We also anticipate seeking organ drug designation that would grant us seven years of marketing exclusivity upon BLA approval.
That may be applicable to mirror liver ecolab, we anticipate seeking an <unk> designation that would allow us to receive greater interactions with the FDA during development and a priority review designation upon BLA submission.
We also anticipate seeking orphan drug designation that would grant us seven years of marketing exclusivity upon BLA approval.
Our team will also be turning its attention to pre-commercial activities, such as pricing and reimbursement discussions due to the potential short duration of these trials.
As I wrap up my comments around miroliverELAP, it's valuable to highlight that our pipeline has always been sequenced so that the development of future product candidates can benefit from the learnings of our prior product candidates. This sequential derisking strategy started with our first two products that utilize perfusion decellularization to produce hernia repair and advanced wound care products from forcing livers. Both products received five 10-K clearance from the FDA and have been safely implanted in thousands of patients, and we're out licensed in 2019, so we could focus entirely on organ transplant. The significance of these two products today is that the clinical and regulatory learnings around perfusion deceleration helped us inform certain decisions relating to miroliverELAP.
It's valuable to highlight that our pipeline has always been sequenced so that the development of future product candidates can benefit from the learnings of our prior product candidates. The sequential Derisking strategy started with our first two products that utilize perfusion deceleration to produce hernia repair.
Fair and advanced wound care products reinforcing livers.
<unk> products received five 10-K clearance from the FDA and have been safely implanted in thousands of patients and we're out license in 2019, So we could focus entirely on organ transplant.
The significance of these two products today is that the clinical and regulatory learnings around perfusion deceleration helped us.
Inform certain decisions relating to neuro liberty lap.
The reason that I leave you with this final thought is that while liver dialysis is an excellent commercial market opportunity on its own, the learning from miroliverELAP should also prove valuable towards informing some of the developmental aspects of our fully implantable bioengineered organs because miroliverELAP is now the first time we are utilizing perfusion deceleration plus recellularization.
The first time, we are utilizing perfusion deceleration plus reseller innovation.
Moving onto our fully implantable bioengineered organs, mirokidney and miroliver, we remain on track to submit our pre-IND request for both programs in 2023. And similar to miroliverELAP, we will have a better sense of timing regarding their path to the clinic after we received the FDA responses. As a reminder, we have already achieved very important proof of concept in both of our fully implantable programs. We published the results of a study in 2021 done in collaboration with the Mayo clinic announcing the successful implantation of our bioengineered livers into large animals. This study showed valuable proof of concept data from miroliver and also for our entire deceleration and recellularization platform technology.
And similar to miroliverELAP, we will have a better sense of timing regarding their path to the clinic after we received the FDA responses. As a reminder, we have already achieved very important proof of concept in both of our fully implantable programs. We published the results of a study in 2021
done in collaboration with the Mayo clinic announcing the successful implantation of our bioengineered livers into large animals. This study showed valuable proof of concept data from miroliver and also for our entire deceleration and recellularization platform technology.
Our kidney team has also delivered exciting news regarding the development of our fully implantable bioengineered kidney. During our second earnings call, I shared that our kidney team successfully demonstrated early urine production and protein retention in our preclinical bench testing. We believe that this is the first time that a bioengineered kidney has produced urine, an important milestone in the development pathway.
During our second earnings call I shared that our kidney team successfully demonstrated early urine production and protein retention in our preclinical bench testing.
We believe that this is the first time that a bioengineered kidney has produced year end an important milestone in the development pathway.
Fast forward to the third quarter, the same kidney team was selected as a finalist by KidneyX to participate in the innovation Kidney Winter Showcase at ASN Kidney Week earlier this month. As many of you know, KidneyX is a partnership between the US Department of Health and Human Services and the American Society of Nephrology with a mission to accelerate innovation in the treatment of kidney disease. This is the second time Miromatrix has been a KidneyX finalist, so a great accomplishment for Miromatrix. I'd like to specifically acknowledge Emily [inaudible] and our scientific kidney team members for being recognized by such a prestigious organization.
As many of you know kidney acts as a partnership between the U S Department of health and human services and the American Society of Nephrology with a mission to accelerate innovation.
In the treatment of kidney disease.
This is the second time neuro matrix has been a kidney ex final ish, so a great accomplishment for marrow matrix.
I'd like to specifically acknowledge Emily [inaudible] and our scientific kidney team members for being recognized by such a prestigious organization.
Moving away from our pipeline updates, I would like to conclude my portion of this call by sharing a couple of business updates related to strengthening of our IP portfolio and a strategic hire. On the intellectual property front, you may have seen that we recently issued a press release regarding the receipt of a new path for methods of recellularizing tissue or organ for improved transplantability.
On the intellectual property front you may have seen that we recently issued a press release regarding the receipt of a new pattern for methods of reseller is any tissue, Oregon for improved transplant ability.
This new patent covers the revascularization of decellularized organs and tissues encompassing all types of organs, including kidneys, liver, lungs, and heart. This is our 119th-issued patent relating to our technology platform in the United States and major markets worldwide. We continue to believe that Miromatrix possesses the core patent related the profusion decellularization and recellularization, which is a desirable position for us to begin.
Cellular is organs and tissues encompassing all types of organs, including kidneys liver lungs and Hearts. This is our 119th issued patents relating to our technology platform in the United States and major markets worldwide. We continue to believe that Bureau matrix possesses the core patent.
Related the profusion deceleration and reseller innovation, which is a desirable position for us to begin.
On the hiring front, we announced the appointment of Dr. Jack Lake as our new Medical Director. Dr. Lake brings tremendous expertise and knowledge of liver and whole organ transplantation to our team, which we believe will prove invaluable on multiple fronts. Dr. Lake will be on-site one day per week, while remaining in his current roles at the University of Minnesota as Professor of Surgery and Medicine, Chief of Hepatology, and Executive Medical Director for solid organ transplantation. Dr. Lake brings so many other relevant credentials to our organization that we highlighted in his hiring press release that I would like to encourage you to take a look at where. We are delighted to have Jack on our team.
Dr Lake brings tremendous expertise and knowledge of liver and whole organ transplantation to our team, which we believe will prove invaluable on multiple fronts Doctor Lake will be on site one day per week, while remaining in his current roles at the University of Minnesota as professor of surgery and medicine.
Chief of Hepatology <unk>.
<unk> executive medical director for solid organ transplantation. Dr. Lake brings so many other relevant credentials to our organization that we highlighted in his hiring press release that I would like to encourage you to take a look at where.
We are delighted to have Jack on our team.
I will now turn it over to Jim Douglas, our financial officer, to discuss our financial results in the third quarter of 2022.
Jim Douglas: Thank you, Jeff. We finished the third quarter with cash and investments totaling $31.5 million, as compared to $38.6 million at the end of the second quarter. We continue to believe this is sufficient to fund the company through 2023. Additionally, we have not accessed our ATM facility that we put in place earlier this year.
We continue to believe this is sufficient to fund the company through 2023.
Additionally, we have not accessed our ATM facility that we put in place earlier this year.
Moving on to the income statement, operating loss was $7.8 million and $23.2 million for the three and nine-month periods ended September 30th, 2022, as compared to $5.2 million and $11.5 million for the three and nine-month periods ended September 30th, 2021. The increase in operating loss for comparable periods was primarily attributable to increased research and development costs and general and administrative costs, notably, cost increases relating to being a public company, payroll, and lab supplies.
As compared to $5 2 million and $11 $5 million for the three and nine month periods ended September 32021.
The increase in operating loss for comparable periods was primarily attributable to increased research and development costs and general and administrative costs.
Notably cost increases relating to being a public company.
Payroll and lab supplies.
Net loss was $7.6 million or 37 cents per share and $23 million or $1.11 per share for the three and nine-month periods ended September 30th, 2022, as compared to $5.1 million or 25 cents per share and $9.2 million or $1.08 per share for the three and nine-month periods ended September 30th, 2021. The increase in net loss for comparable periods was primarily attributable to the same cost increases described with an operating loss above plus one-time gains recognized in the first quarter of 2021 that impacts the nine-month period to period comparison. The increase in share count for the nine-month comparable periods is attributable to the issuance of IPO shares in June 2021.
As compared to $5 1 million or <unk> 25 per share and $9 2 million or $1 eight per share for the three and nine month periods ended September 32021.
The increase in net loss for comparable periods was primarily attributable to the same cost increases described with an operating loss above plus one time gains recognized in the first quarter of 2021 that impacts the nine month period to period comparison.
The increase in share count for the nine month comparable periods is attributable to the issuance of IPO shares in June 2021.
And in closing, we are looking forward to presenting at the upcoming Craig Hallum and Piper Sandler Investor Conferences, and hope to see many of you there. With that, I'll turn the call back over to the operator and open the line for questions. Thank you.
With that I'll turn the call back over to the operator and open the line for questions. Thank you.
Yeah.
Operator: Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star then one on your telephone keypad. [inaudible] your line is in the question queue. You may press star then two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please while we poll for questions.
Now be conducting a question and answer session.
I would like to ask a question. Please press Star then one on your telephone keypad.
You mentioned, Ken wanted to get your line is in the question queue.
You May push star thing too if he would like to remove your question from the queue.
All participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys, one moment, please while we poll for questions.
Our first question is from Alex Nowak of Craig Hallum Capital Group. Please go ahead.
Okay.
Jason Kreyer: Good afternoon, everyone. This is Jason on for Alex. First off, congrats on the big milestone guidance. I guess starting off from--I guess, how are you thinking about a timeline to potentially hear back from the FDA? And what are you expecting to hear back as far as any back and forth that might be required with the agency?
I guess starting off from us.
I guess, how are you thinking about a timeline to potentially hear back from the FDA.
And what are you expecting to hear back as far as any back and forth that might be required with the agency.
Jeff Ross: Yeah, hi, Jason. This is Jeff Ross. Thanks for the congratulations. I think as we highlighted in the call, this is a big milestone as we look at pioneering a whole new class of therapeutics. With the IND process, one test submitted, we look to have feedback from the FDA roughly around 30 days or so to get the initial. feedback from them on the application and any additional questions they have. So we're really looking forward now to move into that phase to be able to engage in that level of dialogue.
Jeff Ross Thanks for the congratulations I think as we highlighted in the call. This is a big milestone as we look at pioneering a whole new class of therapeutics.
With the IND process, one tests submitted we look to have feedback from the FDA roughly around 30 days or so to get the initial.
Feedback from them on the application and any additional questions. They have so we're really looking forward now to move into that phase to be able to engage in that level of dialogue.
Jeff Ross: Thanks, that's helpful. I guess kind of following up on that, anything major to report that within the IND filing that we may have not discussed before that is of note? And then just general confidence from you guys that it will get accepted based on your previous conversations with the FDA and their expectations.
Within the IND following.
Following our filing that we may have not discussed before that is of note and then just general confidence from from you guys.
It will get accepted based on your previous conversations with the FDA and their expectations.
Jeff Ross: Yes, I think if you look at how we've executed over the past year, we started off the year with our pre-IND submission, and as we highlighted before, we had really good dialogue and feedback from the FDA in terms of what they were looking for in an IND submission. That allowed us to really go forward and gather that data and put together what we feel is a really strong IND package to be able to submit that to the FDA. With that notion, we know that this is a new class of therapies. We've kind of hit this on before and we do expect that the FDA likely will have a couple of questions around this technology, but I would say going into this we're incredibly confident being able to work through any questions from the FDA to ultimately lead to a clearance.
That allowed us to really go forward gather that data and put together what we feel is a really strong IND package.
To be able to submit that with the FDA.
With that notion we know that this is a new class of therapies.
Kind of hit this on on before and we do expect that the FDA likely will have a couple of questions around this technology, but I would say going into this we're incredibly confident.
Being able to work through any questions from the FDA to ultimately lead to a clearance.
Jason Kreyer: Yes, that all makes sense. And I guess kind of just around maybe one for Jim. With the IND filing now submitted, what kind of activities are underway to prepare for the trial? Is there any additional staffing that's needed? And then, with the trial launching early in 2023, how should we think about kind of expense ramp and additional hiring that might be needed?
And I guess kind of Max just around maybe one for Jim.
IND filing now submitted what kind of activities that are underway to prepare for the trial.
Is there any additional staffing that's needed and then with the trial launching early in 2023, how should we.
Think about kind of expense ramp and additional hiring that might be.
Jim Douglas: Yes, we're always looking for Blue chip talent, and I think that Jeff highlighted the hiring of Dr. Lake recently and also in his remarks he mentioned the fact that we're in a fortunate position now to be talking about pricing and reimbursement and pre-commercialization strategies. So that will be on the top of our minds here as we get towards year-end. And as far as the trial itself goes, the trial size that Jeff mentioned is five to 15 patients with a very quick follow-up, so a little different than most trials. Our burn actually goes down as it relates to miroliverELAP versus what it was in the developmental stage. So our cash burn, we still feel confident that we're going to have enough cash to get us through 2023 based upon the cash we have on our balance sheet today. So the speed and size of that miroliverELAP trial is something important to highlight.
Hiring of Dr. Lake recently and also in his remarks. He mentioned the fact that we're in a fortunate position now to be talking about pricing and reimbursement and pre commercialization strategies. So that will be on the top of our minds here.
As we get towards year end and as.
As far as the trial itself goes.
Trial size that Jeff mentioned is.
Five to 15 patients with a very quick follow up so.
A little different than most trials are burn actually goes down as it relates to <unk> versus what it was in the developmental stage.
So our cash burn we still feel confident that we're going to have enough cash to get us through 2023 based upon the cash we have on our balance sheet today. So.
The speed and size of that real Liberty lab trial is something important to highlight.
Jason Kreyer: And I guess with miroliver and mirokidney progressing down the pathway as well, I mean, any kind of ramp up in expenses we should be thinking about there just kind of [inaudible] of all your programs into 2023?
Progressing down the pathway as well I mean, any any kind of ramp up in expenses, we should be thinking about there just kind of wholesome of all your programs into 2023.
Jim Douglas: Two of those would stay at a similar rate as we have today as far as the R&D development of the organs themselves. So I think that we would envision that the burn we've experienced through the second half of 2022 is likely not going to be too dissimilar to what we see in the first half and the potential second half of 2023.
We would envision.
The burn we've experienced through the second half of 2022 is likely not going to be too dissimilar to what we see in the <unk>.
First half of the country's second half of 2023.
Jason Kreyer: Okay, great guys. I'll hop back into the queue. Thanks for the question.
Jim Douglas: Thank you.
Okay.
Operator: The next question is from Matthew O'brien of Piper Sandler. Please go ahead.
Philip Heinle: Hey, this is Phil on for Matt. Thanks for taking my questions. And just for starters, congrats on the milestone, it's definitely a big deal.
I guess just in terms of those early commercialization conversations that you guys are starting to have, this being such an innovative and novel product, what do you expect in terms of reimbursement? Obviously, it's difficult to kind of figure out where reimbursement might land, but how are you even starting the patients and what is that looking like?
This being such an innovative and novel product.
What do you expect in terms of reimbursement obviously.
It's difficult to kind of figure out where reimbursement might land, but how are you even starting the patients and what is that looking like.
Jeff Ross: Yes, I think you've hit on it. With this pioneering and new class of medicine, we're going to make sure we have all the right stakeholders involved and getting input from all different angles. I think the value that this is providing to the healthcare system is enormous and so we'll be taking guidance from a lot of folks that have sort of been in this realm from new classes of Medicine. I think on a somewhat comparative scale, there's been new approvals for things like gene therapies, CAR Ts, et cetera that are value-based reimbursement approaches and I think this is not dissimilar.
Does this is pioneering a new class of medicine, we're going to make sure we have all the right.
Stakeholders involved and getting input from.
All different angles.
I think the value that this is providing to the healthcare system is enormous and so we'll be taking guidance from a lot of folks sort of.
And in this realm from.
New classes of Medicine I think.
On a somewhat comparative scale, there's been new approvals for things like gene therapies car Ts et cetera that are value based reimbursement approaches and I think this is not dissimilar.
Philip Heinle: No, that makes a lot of sense. And I guess, just one clarification question here. Just how hard is that upgrade from the current CRRT system to the miroliverELAP compatible one? [inaudible] a simple software update and you can fully utilize the current installed base of those systems?
Just how hard is that upgrade from the currency <unk> system.
Neuro liver <unk> compatible one virus candy net right.
A simple software update.
And you can fully utilize the current installed base of those systems.
Jeff Ross: Yes, Phil, I think you're looking at that exactly right from the standpoint of we were able to kind of take that existing system and through some software updates, enable us to create and support this system to be able to have our external liver, our bioengineered liver external to the patient and then be able to utilize that system to essentially do liver dialysis.
<unk> delivered liver dialysis.
Philip Heinle: That's great. And then I guess just to kind of put a finer point on things, and just because it was in the press release with the patents that cover all types of organs, are you starting to look at more organs I would guess for your system here or are you still focusing most of your bandwidth on the kidney and the liver at this point?
Are you starting to look at more Oregon.
I would guess.
For your.
System a system here are you still focusing most of your.
Jeff Ross: So that's a really good question. I mean, if we do look at this, I mean, one of the reasons we chose liver and kidney for the first organs is 95% of those who are waiting for an organ today are either waiting for a liver or kidney. On the liver, we know there is no alternative therapies besides transplant. On the kidney side, we know the only alternative therapy is dialysis, which we've highlighted before. While it is lifesaving technology, the five year mortality rate with that is still 50% or higher, so we've really focused on those two organs that start with both from the need in the market size. And we will continue to keep the focus on that. And our goal has always been once we start getting into human clinical studies and further, that would be the point that we'd look to start to expand this into long or hard for some of the other programs because we feel strongly to keep the focus and that really strong need is going to be beneficial for us to execute and be able to bring that therapy to patients.
On the liver, we know there is no alternative therapies. Besides transplant on the kidney side, we know the only alternative therapies dialysis, which we've highlighted before.
While it is lifesaving technology, the five year mortality rate with that.
Still 50% or higher so we've really focused on those two organs that start with both from the need in the market size.
And we will continue to keep the focus on that.
And our goal has always been once we start getting into human clinical studies and further.
That would be the point that we'd look to start to expand this into long are hard for some of the other programs because we feel strongly to keep the focus and that really strong need is going to be beneficial for us to execute and be able to bring that therapy to patients.
Multiple speakers: [Philip Heinle] No, absolutely, thanks for that color, and again, congrats on the milestone here guys. Thanks so much. [Jeff Ross] Absolutely, thank you.
Operator: Ladies and gentlemen, we have reached the end of the question and answer session and this concludes today's conference. Thank you for joining us. You may now disconnect your lines.
Yes. Yeah.
Yeah.