Q2 2023 Humacyte Inc Earnings Call
Yes.
[music].
Good morning, ladies and gentlemen, and welcome to the human side second quarter results Conference call. Currently all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time.
As a reminder, this conference is being recorded I will now turn the call over to Loren Mac with life Science Advisors. Please go ahead.
Thank you operator before we proceed with the call I would like to remind everyone that certain statements made during this call are forward looking statements under U S Federal Securities laws.
These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.
Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC.
Forward looking statements made during this call speak only as of the date hereof and the company undertakes no obligation to update or revise the forward looking statements except as required by law.
Information presented on this call is contained in the press release, we issued this morning and in our Form 10-Q, which after filing may be accessed from the investors page of the human psyche website.
Joining me on today's call from humans site, our Doctor, Laura Nicholson, President and Chief Executive Officer Dale.
Phil Sanders, Chief Financial Officer, and Chief Corporate Development Officer, Doctor, Heather Pritchard, Chief operating Officer Dr.
Doctor Nicholson, who will provide a summary of the company's progress during the quarter in recent weeks and Dale will review the company's financial results for the quarter ended June 30th 2023.
Following their prepared remarks, the management team will be available for your questions.
I will now turn the call over to Doctor Nicholson.
Thank you Lauren.
Good morning, everyone and thank you so much for joining our second quarter 2023 financial results and business update call.
As we enter into the second half of 2023.
We continue to be excited about the progress we've made so far this year and advancing our universally implantable bioengineered human tissue product candidate the human cellular vessel are H, a G and multiple indications.
As a recognition of the groundbreaking nature of the H a V C.
The F D. A issued a regenerative medicine advanced therapy, or our math designation for the trauma indication in may.
In July we announced completion of enrollment of our phase three trial in vascular trauma.
Based on the 30 day end point of this pivotal trial, we will present top line results for the trial during Q3 of this year we.
We remain on target for filing our biologics licensing application or BLA with the FDA during Q4 of this year.
Reinforcing the importance of the H a V and war time scenarios, we're proud of the highly successful outcomes to date with our humanitarian program in Ukraine.
And lastly, we recently announced our collaboration with the juvenile diabetes Research Foundation or J D. R F.
To advance our bio vascular pancreas product candidate.
During this call I'll review these recent highlights in more detail before turning the call over to Dale for a review of our financial results. Then we'll be happy to open up the call to take your questions.
I'll begin with our H a V program in vascular trauma.
We're excited to have recently completed the targeted enrollment of our phase two three V O five trial of the H a V in vascular trauma repair.
As a reminder, the V O five trial is a single arm open label pivotal study of patients suffering from vascular trauma injuries.
The primary efficacy assessment is based on the 30 day patency of the human cellular vessel in patients who have vascular trauma oven extremity.
Our benchmark for this single arm study is the performance of synthetic grass and treating trauma patients, which is derived from a comprehensive review of the literature.
At the completion of V O five target enrollment in July of.
Total of 68 patients had received the H a V for trauma.
Of which 51 comprised of the target population of injuries in the extremities.
Extremity injuries importantly are the vast majority of traumatic injuries in both civilian and military settings.
Database lock for the V O five trial will occur later this month.
And we're looking forward to presenting the topline results of the V O five vascular trauma trial later in this quarter stay tuned.
We anticipate that the V O five trauma trial will serve as the backbone of our BLA filing later this year.
The current target indication for the H a V is for treatment of extremity vascular trauma when synthetic graft is not indicated and when autologous vein is not feasible.
Our recent armet designation from the F D. A combined with our priority designation from the Defense Department.
It gives us a higher chance for priority review of our planned BLA filing in the trauma indication.
Priority review typically reduces review time to approximately six months after BLA acceptance as compared to the standard review process.
As you know the H a V is also being used in Ukraine under a humanitarian aid program nine.
19 vascular trauma patients have received the H a V in Ukraine and most of these patients who were wounded had blast injuries and shrapnel injuries in the ongoing conflict.
Outcomes from the Ukraine wartime experience are being presented today at the 2023 military health system Research Symposium in Florida.
Ukrainian surgeons treating war wounded patients with the H a V are reporting a very high success rate at.
30 days after implantation the limb salvage in patients treated with the H a V. It's 100%.
This is a remarkable result, especially in light of the fact that an estimated 20000 to 50000 war wounded patients have lost limbs and Ukraine since the start of the conflict only 18 months ago.
In addition available data from our humanitarian aid experience indicate that the 30 day patency or blood flow in the H a V was present in 95% of patients.
Importantly in the treatment of these wartime traumatic injuries. There were no instances of infection of the H a V.
The real world data from the Ukraine experience will be submitted along with our V O five trauma that data in our BLA submission as additional evidence of the utility of the H a V in wartime settings.
Turning now to our trial of the H a V. An arteriovenous access in hemodialysis patients with end stage kidney disease as you'll recall, we announced enrollment completion of our phase III V O seven trial in April of 2023.
Since the primary efficacy analysis will evaluate the usability of the conduits for dialysis during the first year. Our top line results are anticipated to be available around the second quarter of 2024.
We'll also be evaluating the rate of dialysis related infections as a secondary endpoint.
Both endpoints will compare the H a V to the most commonly used method for arteriovenous access which is the autogenous arteriovenous fistula.
With regard to publications, we're continuing to add to the growing body of literature supporting the H a V across multiple indications.
We recently announced the publication of a preclinical study in the journal of vascular surgery vascular science that provide the scientific basis for the low rates of infections that we've observed in our clinical trials with the H a V.
Across our clinical trials in dialysis access and peripheral artery disease and in trauma, we've observed a low infection rate of the H a V. In particular, the HIV infection rate appears substantially lower than what it's been reported for synthetic graph such as those made out of teflon.
A recent publication shows that the resistance of the H a V. Two infection may be due to its favorable interactions with the body's immune cells.
When comparing the H a V to teflon graph in the laboratory, we found that human immune cells can function and thrive when placed on the H a V material.
But these same cells quickly die when placed on teflon.
Improved survival and function of human immune cells may mean that the immune system can fight off bacteria that come in contact with the H a V.
Thus avoiding the development of an infection.
In contrast immune cells on Teflon die quickly, meaning that they're not able to fight off bacteria that are attached to the surface.
This difference in human immune cell function may be leading to the low observed infection rate in the clinic. This.
This publication is important because it provides a strong scientific basis for the very low infection rate of the H a V that we've observed in over 500 patients to date.
These results have broad implications for all of our intended H a V indications and further support its potential as a solution to some of the problems of synthetic vascular grafts.
Going further we are happy to announce our collaboration with the juvenile diabetes Research Foundation or J D. R. F. This was announced in April of 2023.
J D R F as the world's largest nonprofit funder of type one diabetes research.
A site in the J D. R. F are collaborating on the development of human sites bio vascular pancreas or B V P.
Which is our product candidate for the treatment of patients with type one diabetes.
Type one diabetes like all other autoimmune diseases is a growing problem in the western world.
So nearly 1.5 million people suffer from type one diabetes in the U S.
Last year fewer than 1000, curative pancreas transplants were performed.
The dearth of transplants is because transplanting the whole pancreas is a highly risky procedure.
The decrease risk.
Insulin, making islands, which are less than a millimeter in size have been injected into the liver or underneath the skin of diabetic patients.
However, I lifts that are injected can often die due to a lack of oxygen and nutrients that they need to stay alive.
Our BV P is designed to enable the delivery and survival of insulin producing islands by providing them enough oxygen and nutrients using the H a V as a carrier into the bloodstream of the patient.
We've already previously reported that rodent size B V piece can reverse diabetes in rats.
2023, we've been testing patient size versions of the BV P in primates.
Recent experiments have shown that I lived in the BV P survive in a multi week model after implantation into the animal and continue to make insulin after implantation.
These results are extremely encouraging because this supports the ability of the BV P to deliver a curative number of insulin producing islets into a large animal.
Work in large animals is planned going forward, including the use of the BV P in diabetic animals.
And with that I'll now turn it over to Dale for a review of our financial results and other business developments.
Thank you Laura.
As of June 32023, we had cash and cash equivalents of 100.
<unk> 6 million.
In May 2023, we reported the completion of the funding arrangement with Oberland capital up to $160 million of which we have received $40 million.
We believe our cash and cash equivalents and plan pending the Oberlin funding agreement.
Adequate to fund the operations past the anticipated timeline for approval and commercialization of the HIV and vascular trauma.
There was no revenue for the second quarter of 2023, and the six months ended June 32023.
Revenue was $1 3 million for the second quarter of 2022, and $1 5 million six months ended June 32022.
Revenue for 2022 was related to a grant supporting the development of the HIV.
Research and development expenses were $20 5 million in second quarter of 2023 compared to $14 7 million for the second quarter of 2022.
And were $37 8 million for the six months ended June 32023, compared to $31 million, maybe six months ended June 32022.
The current period increases resulted primarily from increased personnel and external services expenses.
Supporting the expanded research and development initiatives and our clinical trials.
Including preparation for the HIV testing trauma trial completion, and planned BLA filing as well as expansion of clinical development of HIV and access.
General and administrative expenses were $6 2 million for the second quarter of 2023.
Compared to $5 2 million for the second quarter of 2022.
And were $11 4 million for the six months ended June 32023, compared to $10 9 million from six months ended June 32022.
The current period increases resulted primarily from increased personnel and external services costs.
Primarily driven by preparation for the planned commercial launch of HIV and vascular trauma.
Other net income or expense was net income of $4 million for the second quarter of 2023 compared to net income.
$55 4 million for the second quarter of 2022 for.
For the six months ended June 32023.
Other net expense of $10 4 million compared to other net income up $57 3 million for the six months ended June 32022.
The current period increases in other net expense resulted primarily from the noncash remeasurement of the contingent earn out liability associated with the August 2021 merger with Alpha Healthcare acquisition Corp.
Net loss was $22 7 million for the second quarter of 2023 compared to net income of $36 9 million for the second quarter of 2022.
Net loss was $59 7 million for the six months ended June 32023.
Compared to net income of 17.0 a million.
For the six months ended June 32022.
The current period increase in net loss resulted from the noncash increase in other net expense.
And increased operating expenses as described above.
Total net cash used was $35 2 million for the second quarter of 2023.
Third to $36 5 million for the second quarter of 2022.
Currently our decrease in cash used related to proceeds from our <unk> funding transactions.
We're very pleased to have entered into the funding arrangement with Oberland capital that extends our cash runway and provides additional resources to support our development and commercialization initiatives, particularly as we move closer to our planned BLA filing and commercial launch.
We had multiple debt type arrangements offered to us and we selected the oberland structure that best match their repayment commitment with our future expected growth in revenues.
We are excited to partner with the team at Oberland capital and appreciate their extensive experience in the life science industry.
With that I'll turn it back over to Laura for concluding remarks.
Thank you Dale.
We're very pleased with our progress so far in 2023, as we move closer to BLA regulatory filing in vascular trauma I'd like to take a moment to thank the human site team as well as our partners for their continued commitment to our programs.
Our colleagues in Ukraine, who use the H a V to save limbs and lives and war wounded patients also deserve our appreciation and thanks.
We're approaching a transformational time not only for our company, but also for patients suffering from a range of vascular diseases.
Across our clinical programs. The H a V has already accumulated more than a thousand patient years of experience, including in vascular trauma, a V access and peripheral artery disease.
Our large animal studies that are ongoing and heart bypass surgery and type one diabetes continue to support the flexibility and the potential impact of our transformational manufacturing platform.
And we are continuing to study the H a V in order to maximize the full potential of the H a vs value for patients and for our investors.
We look forward to keeping you updated with our progress starting with our upcoming anticipated V O five trial topline results.
Reporting later this quarter.
Thank you all for joining us today.
Operator, we're ready to take questions.
Thank you if you'd like to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question. Kim You May press star two if you'd 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.
Our first question comes from the line of Ryan Zimmerman with BTG. Please proceed with your question.
And congrats on all the progress bar in Dallas are nice to see the enrollment is complete.
I was struck by the patency rates in Ukraine that you've seen thus far lora and I'm wondering if.
You can talk about those.
In the context of the prior studies that we have seen that they appear to be.
Far better than maybe what we've seen in some of these prior studies and so.
How does that inform your view.
Around kind of what to expect when we see top line results next quarter.
Well the patency results in Ukraine, you know have been outstanding.
You know, they're actually not that different from some of the early patency results that we've talked about for V. O five in some in some calls that we've done earlier you know I would say that this is a 30 day patency rate.
And it's also in relatively young healthy patients you know the the wars the warriors in Ukraine don't have a lot of peripheral vascular disease. So so this really allows the H a V to shine in the sense that it's being implanted into relatively healthy people with severe injuries, but relatively healthy.
People and so the 100 per cent patency at 30 days really reflects the inherent properties of the H a V.
No. That's that's very helpful and and you know certainly encouraging and then as we're thinking about BLA submission.
Do you have kind of come in later this quarter or excuse me later this year I should say in the fourth quarter.
What are you guys doing to kind of derisk that an end and how should investors think about that process and just kind of getting that across the goal line and time you know as stated.
Well I think theres, a number of things that we've done to derisk. The BLA filing first and perhaps most importantly, our our manufacturing process, which is currently at commercial scale hasn't been in use for the last two years and in fact, the F. D. A reviewed a comprehensive.
Ive comparability data package for our current manufacturing system two years ago back in 2021 much of that are part of the BLA frankly, it's already been written along with our preclinical results. So the the final piece of the BLA, which which needs to be pulled together is our clinical outcomes.
From V O five but also the Ukraine data are going to supplement the BLA filing.
Importantly, the primary endpoint on these on these both of these groups of patients is 30 day patency, so having the data come together in this finite number of patients is something that we see is very doable for fourth quarter.
Yeah, No question, Alright, well that's it for me congrats on the progress.
Thank you.
Thank you. Our next question comes from the line of Josh Jennings with TD Cowen. Please proceed with your question.
Hi, good morning, and thanks, Gordon Dale and Echo congratulations.
Congratulations on all the progress.
Wanted to just ask about the potential cost effectiveness angles that hemostat can take rate should be in trauma.
<unk> got reduce infection, the operation rate potential versus synthetic craft reduce overtime for HIV, which this atmosphere crafts.
Maybe just talk about those angles and just how close that those data could accrue and support the ultimate ultimate.
The launch.
Yeah, Josh Thanks for that question, we believe that the H a V will offer an outstanding alternative for injured patients both civilian and war time.
Compared to both synthetic grafts and assassin insane.
With respect to synthetic grafts as.
As we mentioned earlier in the call that there's.
There's a comprehensive literature review that we've done of synthetic graft outcomes in vascular trauma.
The result of that we're going to share a at the time, we share our topline results, but suffice to say the the rate of amputation and the rate of conduit infection from that Oh systemic lifts. The systematic literature review shows us that the H a V provides a great affair.
Given this benefit both in terms of limb salvage and in terms of infection.
We can look directly at the published literature and at claims data to understand what the what the actual costs of this improved.
What the actual cost savings of this improved clinical outcome will be.
And that is really allowing us to put together a comprehensive and really compelling cost models that we believe show the H a V will offer not only improved outcomes, but also decrease clinical costs compared to synthetic grafts.
As compared to vein.
What we see is that the H a V is available off the shelf as we've always mentioned and in fact can be removed from its container are in the operating room in about two minutes. A this is a vast improvement compared to the just the time it takes to harvest saffran its name from a patient.
Which but by the time, you prep the leg and take the zain out and prepare the vein and then close the leg wound that's easily an hour.
So having that extra hour for the patient in terms of speed of Revascularization that also leads to a demonstrable decrease in the rate of amputation for patients with vascular injury. So we believe there will be clear and compelling our health economic basis.
For for utilizing the H AZ and vascular trauma.
Compared to both the synthetic grafts, but also vein.
Thanks for that.
The cause.
Could you review the modular BLA submission that's in play for sure.
For the vascular trauma indication and just was hoping you could review the interest the ability to leverage that the that filing and those those modules on subsequent filings for new indications.
It keeps the access in M. P. A to you down the line.
Thanks for taking the questions.
Yeah, Josh so the the H a V. As you know even though it's been studied in three different clinical indications is all the same vessel. It's all growing in the same way. The dimensions are the same all of the characteristics are identical across our different Ah Ah clinical indications what this means is.
That most of the modules. The BLA is our five modules, having to do with manufacturing and quality data and preclinical data and and summaries and then Ah clinical efficacy and safety.
Much of the BLA that we're going to submit for trauma will be identical to up to a follow on BLA that we would file for example in a D access or even in P. E D.
And that really allows us to utilize the work that we've done so far.
So that win follow on clinical indications become available we can we can leverage our prior work and just adding additional clinical data are on the same HIV product candidate.
Yeah.
Excellent. Thank you.
[laughter].
Thank you. Our next question comes from the line of Matthew O'brien with Piper Sandler. Please proceed with your question.
Great. Thanks for taking my questions.
Laura so for starters just on on the topline results.
What should we be looking at more specifically with that data and then are there any confounding factors that we need to be considering that may pop up that that.
They aren't overly clinically important but just that we should be aware of.
Well, we're going to share topline results later in this quarter and so I I hate to highlight those in advance of database lock, but what I will say is that we have more than 50 patients who had extremity trauma injuries, which are going to comprise our efficacy set.
In addition, the total V O five enrollment is roughly 70 patients now.
And we're going to provide safety data on all of the patients who received the HIV and vascular trauma. In addition to the 15 or so patients that we have consented to use their data from Ukraine, you know as far as caveat or or unexpected observations.
You know I I can't really say that we've had any the H a V. A S. I tend to say to to analysts and investors. The H a V. Just keeps being the same product candidate it.
It keeps functioning roughly the same [laughter] year after year, regardless of the indication. So I don't think there's going to be too. Many surprises here based on some of the information that we've shared in prior calls.
Got it well that's great to hear as.
As far as your Crane goes in and you know I don't have a lot of the data points that you guys do but if theres. So many patients that are being affected by this.
Unfortunately, and you've got you've had 19 deployed at this point I'm just wondering about logistics in terms of getting it to them. It would just seem like it's working so well wire more patients not getting yet I don't know if it's just because.
The $19, it's been available or something like that but we're more and more patients not going to get an idea of a home or a follow up for for Dale.
Yeah. So that's a good question, Matt So our original agreement with the with the Ukrainian Ministry of Health, which we entered into I think in May of last year was that the humanitarian effort would last for one year and so we delivered a 30 vessels to Ukraine and they went to five different.
Frontline hospitals again, neither we nor the Ukrainian administered pill understood. How this would go at the time, we were just doing our best to help patients in need the outcomes over the last year and as you heard him.
We have clearly been excellent however R R.
And the initial agreement with the Ukrainian government lasted only a year. We're currently working with the Ukrainian government to actually add hospital sites to our V O five trial.
The V O five trial, even though we've reached enrollment for filing is actually continuing to accrue a few patients because we're interested in gathering as much safety data as we can and so we may add Ukrainian sites, but.
But that that's really an issue that the that we're that we're dealing with the Ukrainian Ministry of health right now in the second phase of this interaction.
Okay got it makes total sense and then Dale did I hear you right that you you used about $35 million of capital in the quarter or cash in the quarter. If I'm doing the math right. I think you have 114, plus about 120 left from the.
The recent.
Deal that you announced so that's about call. It two fortyish, so you're burning through about 35% how does that burn rate look as we get closer to commercialization, which I think is probably about a year away.
Yeah, Matt that the the numbers you quoted are accurate for the first half.
The 2023, we burned.
$35.2 million.
Yeah, I would not expect more than a $40 million burn for the remainder of the year.
And we've given a sense that the oberland transaction combined with how we expect to operate and also the cash on hand, we expect takes us well past the approval and commercialization in vascular trauma, but from a calendar point of view that means going.
To the end of 2025 at a minimum in terms of how we expect to operate.
Yeah.
Got it thank you so much.
Thank you. Our next question comes from the line of Suraj Kalia with Oppenheimer and company. Please proceed with your question.
Good morning, Laura Dale can you hear me all right.
We can hear you.
Perfect Okay.
You mentioned benchmarking for vehicle size, whereas the PTFE grafts and I'm curious if you could expand on that in terms of how should we think about you know the the.
The benchmarking itself because most of these synthetic grafts are studies are.
Somewhat single arms.
On the same lines, but just kind of in your that are pretty diverse array of synthetic grafts. So maybe if you could just give us some additional clarity on how.
How we should think about the control of the comparison.
So the control arm they historical control benchmark for the Z O. Five trial is based on a comprehensive literature review and the structure of the literature review and the meta analysis was actually something that we agreed upon with the FDA before undertaking this.
So this is really a comprehensive review of the world's literature over the last 20 years are using any type of synthetic graft. So this means any anything made out of a plastic. So if this thing. This is excluding things like cryo vein or xenograft for example.
But any synthetic raft of any type used used in vascular trauma over the last 20 years, but this is also high quality study so to your point Suraj. The surgical literature is sometimes messy and Theres a lot of single arm studies that are of low quality. Those studies were excluded with agreement from the F.
So we're focusing on high quality studies and because of that the the benchmark that we've obtained we feel is robust and we will feel we feel will provide excellent support for eventual approval of the HIV in trauma.
Got it.
Laurel against a real fire, how should be think about the site enrollment bell curve remind us how many sites were in the have actually enrolled the 50 or so patients.
So that we can just get the necessity to concentration if any.
Yeah.
So I'm gonna have to estimate here suraj because I don't have these numbers right at my fingertips, but my estimate.
It's up about 15 or 17 sites total haven't rolled our total of 70 patients in the trial.
So on average that would correspond to three or four patients per site per enrolling site. There is clearly some concentration. So there are some sites that are very active trauma centers that have enrolled more than that so for example, Baltimore shock trauma, Denver health and Miami have all.
Enrolled I think more than more than that patient number.
Got it alright did I finally did I hear you correctly in terms of B V. P. You know some components, obviously have been derived from <unk> Sabine VP does two way communication with the surrounding environment, but it should be theoretically would not right.
I'm, sorry, Suraj I didn't understand your question.
So BV P. You know it has a sense glucose right and release insulin.
It should be theoretically it should not be communicating with the outside environment right. So I was just curious hum yawn reconfigured sorry for the background noise you reconfigured some components of the H a V for BV Pete.
Yes. This is correct. So our BV P product candidate consists of the H, a V, which were making and and implanting into patients every day.
The outside of the H a V is coded with a minor layer of islets. These islets can be derived from a donor pancreas. They can also be derived from stem cells potentially even genetically engineered stem.
Stem cells that are minimally immunogenic. So so this is and I lit agnostic platform for delivering a curative number of islets into patients with type one diabetes, what's exciting about the primate studies that I that I've mentioned is that we've been trialing.
Sensually a human sized version of the H a V in primate animals, the islets that we've loaded onto the H a V where primate eyelets not human islets of course, because they would reject immediately but these are primate islets from the pancreas of another animal.
And what's exciting for US is that we've shown that these islands can survive for several weeks after implantation in the B V. P model and their secreting insulin. So this is an excellent proof of concept data point that says that the the overall platform of using the H a V to deliver.
<unk> is likely sound and we have to continue this work, but we view this as very important and exciting.
Got it congrats again and look forward to the data on view five soon.
Thank you.
Yeah.
Thank you as a reminder, if you'd like to join the question queue. Please press star one on your telephone keypad. Our next question comes from the line of Bruce Jackson with the Benchmark Company. Please proceed with your question.
Hi, good morning, and congratulations on all the progress.
I'd like to just ask a follow up question, yeah coronary artery bypass graft program. So I believe the idea was to try to get into first in man.
Transplants and 'twenty 'twenty four I was just curious about where you currently stand in terms of the regulatory discussions with the FDA and if they if that's still the case, if you're still planning to do the first in man in 2024.
I'm going to ask Heather to take that question.
Yeah.
Sure Laura Hi, Bruce So where we stand right now with the coronary bypass program is that we continue to do our primate I N D, enabling studies with primates and we're continuing to do this through the remainder of this year and gather data for the IMD the preclinical.
So part of the IMD for that we still expect to file them.
In 2024.
Laura do you want to add anything else.
Well I think we're going to have to see how these how these results turn out we have begun discussions with the FDA about what a suitable pre.
Preclinical package would comprise and so I would say just stay tuned we will see.
Okay great.
And then with the the large animal work in D V P or you're gonna be I'm doing anything to take a look at the durability.
The French results were great.
Survival for a few months.
Insulin generation, but do you any of the future studies involve looking at the durability of the therapy.
We're absolutely going to be looking at longer time points are in our large animal model.
There's really a couple of questions that are really need to be proved out before we can prepare for a first in human studies. The first question in our minds is whether the B V. P. Construct can support islet survival in insulin production.
Actions, that's really a question that you can answer in just a few weeks you can't implant islets into an environment, where they don't have enough oxygen and nutrients and expect them to survive.
For weeks at a time. So we believe this initial data point isn't it really important proof of concept that the foundational.
Foundational science around the B V P construct is valid.
As a second line of investigation. We're then going to look at the durability of the eyelet survival and insulin production.
This will require studies in the diet and diabetic animals and looking over longer periods of time and so we're gearing up for those studies right now.
Okay, great. Thank you for taking my questions and congratulations again.
Thank you I'm showing no other questions in queue. At this time. This concludes the human side second quarter 2023 results conference call. Thank you all for participating you may now disconnect your lines.