Q3 2022 Humacyte Inc Earnings Call
Okay.
Good morning, ladies and gentlemen, and welcome to the human side, the third quarter I'm getting.
Two 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 call is being recorded.
I will now turn the call over to Novartis American with the lifestyle 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 law.
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.
The 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 will be filed today and may be accessed from the investors page of the Hemocyte website.
Joining me on today's call from Hemocyte, Our Doctor, Laura Nicholson, President and Chief Executive Officer, Phil Sanders, Chief Financial Officer, and Chief Corporate Development Officer, and Dr. Heather Pritchard, Chief operating officer.
Doctor Nicholson will provide a summary of the company's progress during the quarter and recent weeks and Dale will review the company's financial results. 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 for joining us on our third quarter 2022 financial results and business update call.
During this call I'll review, our recent highlights and our progress in our key program before turning the call over to Dale for a review of our financial results. Then we'll be happy to open the call up to your questions.
We had an exciting third quarter in advancing our bioengineered human tissue platform, which produces the human cellular vessel or HIV.
We completed a productive meeting with the FDA in October for arterial trauma indication.
Also in our pipeline, we initiated an important partnership because it illustrates the development of our type one diabetes HIV product candidates.
We've also strengthened our board of directors and our leadership team.
With the respective appointments of Lieutenant General Bruce screens, and Doctor, Cindy Chao, who bring significant experience in public health drug and biotechnology development that will be invaluable as we move closer to our goal of bringing the HIV each market.
I'll begin with an important update on our late stage program for the H, a V and arterial trauma.
The FDA has previously indicated that the HIV for the indication of vascular trauma qualifies for the accelerated approval pathway.
We're pleased to report that we completed a meeting with the FDA in late October <unk>.
Discussions in the meeting more productive and they focused on a statistical plan that incorporate data from our current ongoing Z O five clinical trial and from patients who we have treated in Ukraine.
Does the discussions during this meeting and form our plan to file the BLA for the trauma indication in mid 2023.
I'll reveal five phase two three trial, which is a single arm study evaluating the use of the HIV and trauma injury settings.
Currently has 56 patients enrolled and the results of these patients were shared with the agency in a recent meeting.
In addition to the V O five patients we've treated nine patients to date in Ukraine with the H a V and the results of these implants were also shared with the agency.
We're continuing to work with the FDA on the complete data package that will be necessary for filing the BLA.
Previously, we guided the market to an expectation of approximately 75 total patients that's being needed in order to support a BLA filing in vascular trauma.
Including patients from Ukraine, and from D. O five that guidance of around 75 total patients remains our current estimate.
Importantly, we're also submitting a clinical trial application to Ukraine and preparation for planned addition of Ukrainian sites into the V O five trial.
We continue to be encouraged with our results to date and vascular trauma, which show high rates of patency low rate of amputation and only one case of HIV infection within the V O five trial.
We look forward to continued collaboration and dialogue with the F. D. A as we advance toward BLA filing next year.
The HIV in the vascular trauma context was also the subject of multiple presentations at scientific conferences and publications throughout the third quarter.
Cobra U S Army published an update in task and purpose describing the use of the H a V in treating the war wounded in Ukraine.
In the article it was also noted that officials with the defense Department encouraged human site to collaborate with the medical technology Enterprise consortium or amtech.
AMETEK has provided more than $6 $8 million in funding to humans site.
To develop the H a V for vascular trauma and we're grateful for their support.
At the European Society for vascular surgery annual meeting in September .
Ukrainian surgeons presented patient outcomes from the use of the H a V. The treat war time vascular injury, including blast trauma shrapnel injuries and gunshot wound.
The searches observed that access to the H E. B greatly assisted in limb salvage by improving their ability to perform vascular reconstruction and by eliminating the need to harvest after the thing or venous conduit.
In addition, Dr. Todd RASM Houston presented an update on the H a V for the treatment of vascular trauma at the 44th International Committee of military Medicine World Congress in September .
Dr. Peres mucin spoke to an audience of NATO and other international Surgeons and concluded that injured service members as well as civilians with complex injuries could benefit from the use of a readily available and infection resistant vascular conduit such as the H a V.
That would facilitate quick implantation, especially in the setting of contaminated wounds.
I'll now provide a quick update on our program of H a vs four arteriovenous or a V access in hemodialysis patients.
Enrollment in our current ongoing phase III trial in dialysis access, which is designed to assess the usability of the H a V for dialysis in comparison to autogenous Fistulas.
<unk> is nearing completion of enrollment.
With 227 patients out of a target of 240 total patients as of October 26, we are on taxes on track for enrollment to be completed soon.
Topline results are anticipated one year after enrollment completion based upon the one year follow up period, that's built into the study.
If successful results from the trial will support a BLA filing for the dialysis access indication for the HIV.
As we progress toward commercialization in this indication were continuing to strengthen our relationship with our global partner and shareholder Fresenius Medical care, which is the global market leader in kidney care services products and value based care.
We're partnering with for Nova clinical research arm owned by Fresenius to evaluate complications and costs with dialysis access care for vulnerable patients.
In both the U S and Europe .
Granular data for more than 600000, anonymised patients concerning demographics access complications and failures access infections hospitalizations and mortality is being analyzed to provide targeted information on those dialysis patients who may most benefit from the HIV.
We're also happy to provide updates in our earlier stage programs as we make progress in preclinical studies of the H a V, particularly in type one diabetes and coronary artery bypass grafting or cabbage.
In October we initiated a research partnership with the diabetes Research Institute, which is a global leader in preclinical studies of novel diabetic therapies in order to facilitate the development of our bio vascular pancreas or P V P.
The baby the B V. P is our HIV product candidate that is coated with islets and designed to deliver insulin to type one diabetics.
We're excited for the opportunity to work with the experts at the diabetes Research Institute in Miami and to accelerate the development of the B B P.
Preclinical results from our small diameter H a V program in cabbage were also presented at both the American Heart Association basic cardiovascular Sciences sessions in July as well as at the American Heart Association scientific sessions meeting earlier this month.
In a nonhuman primate model the H a V maintained structural integrity and patency for up to six months post implantation as a coronary artery bypass graft.
In addition, the H a V showed evidence of robust wholesale repopulation and remodeling.
We're excited about our small diameter H a vs that they continue to show promise in an important preclinical cabbage model and we remain hopeful that these each H a V to have the potential to address the long term.
See availability and consistency issues that are associated with the current standard of care, which is harvesting saffran its name.
Finally, he was quite strengthened our board of directors and leadership team this quarter with appointments of accomplished medical and industry experts.
In September we welcomed Lieutenant general Bruce screen to our board of directors.
Green is a former surgeon general of the United States Air Force and is an expert in disaster relief and military medical response operations around the globe.
In addition, we also welcome Dr. Cindy Chao as our Chief regulatory Officer Dr.
Dr. Cal brings over 20 years of industry experience with expertise in global and U S regulatory strategy and policy on biologics small molecules and devices.
We're very pleased to have general Greene and Dr. Kao join us and we look forward to adding their insights and expertise to the human side team.
With that I'll now turn it over to Dale for a review of our financial results and other business development.
Thank you Laura.
As of September 32022.
Cash cash equivalents and short term investments of 171 7 million.
Compared to $225 5 million as of December 31, 2021.
53.8 million net use of cash cash equivalents and short term investments for the first nine months of 2020 to.
Solid from spending related to net operating activities for the period, including clinical into earlier stage research and development programs in preparation for the company's anticipated commercial launch.
We believe that our cash cash equivalents and short term investments are adequate to fund the operations through 2024.
That's the current expected timeline for potential approval of the HIV and basketball Trump.
Revenue was 31000 for the third quarter of 2022.
Hard to point 2 million until the third quarter of 2021.
And was $1 6 billion until the nine months ended September 32022.
Compared to one 1 million for the nine months ended September 32021.
Revenue in all periods related to grants supporting the development of the H E B.
Research and development expenses were $17 3 million for the third quarter of 2022.
Paired to $15 4 million from the third quarter of 2021.
And were $48 3 million for the nine.
Nine months ended September 32022.
Paired to $45 1 million for the nine months.
September 32021.
The current period increases resulted primarily from increased personnel expenses.
To support expanded research and development initiatives and the support of clinical trials.
General and administrative expenses were $6 2 million for the third quarter of 2022.
Compared to $5 4 million until the third quarter of 2021.
And were $17 1 million for the nine months ended September 32022.
Compared to $15 6 million for the nine months ended September 32021.
The current period increases resulted primarily from the transition to being a public company in preparation for the anticipated U S. Commercial launch of the H E B.
Including increased personnel costs professional fees and insurance costs.
Other net expense was $1 8 million for the third quarter of 2022.
Paired to 11.01 billion from the third quarter of 2021.
And other net income was $55 5 million for the nine months ended September 32022.
Compared to other net expense of $9 5 million for the nine months ended September 32021.
The reduction in the other net expense for the current your third quarter Andy.
And the increase in other current net income for the current your nine months resulted primarily from the Remeasurement of a contingent earn out liability associated.
Associated with the August 2021 merger with Alpha Healthcare acquisition Corp.
Net loss was $25 3 million for the third quarter of 2022.
Compared to 31 6 billion for the third quarter of 2021.
Net loss was $8 2 million for the nine months ended September 32022.
Compared to $69 1 billion for the nine months ended September 32021.
The current period decreases in net loss resulted from the reduction in the other net expense.
An increase in other net income described previously.
Partially offset by operating expense increases also described previously.
With that I'll turn it back to Laura for concluding remarks.
Thank you Dale.
To conclude we've made significant progress over the last quarter in both our clinical and preclinical programs.
As we approach year end, we're excited by the coming months and the prospect of bringing this important technology to surgeons and to patients in need and we look forward to providing further updates as we approach clinical and regulatory milestones.
Operator, we're ready to take questions now.
We will now begin the question and answer session to ask a question you May Press Star then one on you touched them set to withdraw your question. Please press Star then two.
The first question is from Josh Jennings with Cowen and company. Please go ahead.
Hi, This is Eric for Josh Thanks for taking the question.
Wanted to start in vascular trauma.
Just thinking about your discussions with the FDA and their thoughts on the inclusion of the Ukrainian H a V experience do you think theres any possibility that the bar for your 75 patient enrollment number could be lowered in your phase III trial, and if that is possible. When do you think we would hear about a lower enrollment target do you have any upcoming FDA meetings.
Where it needs to be discussed.
Thank you Eric This is Laura Nicholas and Yeah, that's a very good and insightful question.
I'll answer it to the best of my ability. So the discussions are at late last month with the F. D. A where productive we shared with them. Both the V O five data and which we've enrolled 56 patients and also the nine patients in Ukraine, which add up to about 65 total patients.
Clearly our results in the Ukraine has been very positive and are strongly supportive of the 56.
Ah patients that we have I N V O five and clearly the Ukraine scenario is a real world scenario, where you could argue the wounds are dirty or and the care of the patients it's more difficult.
I want to be clear the humanitarian use patients in Ukraine are not part of the V. O. Five study at least not yet although we are contemplating adding sites in Ukraine to the V O five trial.
So.
I think it's too early to say that a specific number of patients you know that what we're talking about now with the F. D. A is really statistical tools that will drive that will drive the size of the of the total number of patients that are under consideration.
But it is it remains our estimates.
That the total number of patients. If you were to include the V O five patients and the Ukraine patients, which is now at 65. It remains our estimate that all patients added together is approximately 75, but this is going to be based on finalizing our statistical approach with the agency.
Does that help.
That does yeah that makes sense. Thank you and then secondly, I know it's still early on but as your later stage trials come to an end and we start thinking about topline readouts and potential approvals submissions are is there any work you're doing to set up our organized the commercial infrastructure and again I know, it's still very early on but when do you think we make you more updates on that front.
Dale you want to take that.
Yeah, absolutely Yeah, certainly Eric we've brought on.
The head of commercial operations, BJ, especially which are there's been with the company for a little bit more than a year now.
And he has a team around him that is doing.
It's a long term planning activities that are going to be required to support.
All the commercial launches, but in particular, our initial commercial launch expected in vascular trauma.
Yes, we've talked about before vascular trauma.
The United States is certainly a nice place for the initial launch it's a relatively concentrated market that's.
That's about 200 level, one trauma centers in the United States. So it requires relatively.
A smaller sales force than your other indications like.
And as we can.
Get closer to actual.
Just waited launch date.
We'll continue to add other.
Sales and marketing infrastructure and longer term activities that are required such as reimbursement and patient access.
Things along that nature, and then as we get bigger.
Closer that's when we'll start bringing on the actual sales force.
Okay understood. Thank you for the questions.
The next question is from.
Ryan with Piper Sandler. Please go ahead.
Hey, this is Phil on for Matt. Thanks for taking the questions. Just a quick one on the V. O five trial now call. It 56, plus nine patients here you added you know one patient ex Ukraine in the quarter do you have any you know.
Any line of sight into patient adds here in Q3, Q4 can we expect things to kind of accelerate into the end of the year and early next year.
Oh, Yeah. That's a good question, we have overall been enrolling about one patient per month in the trial.
I'm with you know ebbs and flows certainly you know we are working all the time to accelerate that a we have brought several sites up in Israel in recent months.
And as I mentioned, we're going to be working in the spring with the government in Ukraine to try to bring on several hospitals that have been using the H a V already on the frontline to bring them into the V O five Ah trial, given the rapid use of the H a V in the Ukraine War setting.
We anticipate that adding the site in Ukraine and in Israel will will help to speed enrollment, although inherently by the nature of trauma. It's it's it's it's hard to predict but I would say overall you know during the trial, we've enrolled a little more than one patient per month.
And there's no it we're hoping that that rate maintains or or accelerate somewhat.
No that's very helpful and I guess just shifting gears here can you speak to you know you entering this partnership with the D. R. I you know down in Miami.
And when we could maybe start to see some preclinical data on the B B P. Thank you so much.
Yes, I think you know we've we've been in discussions with the with the leaders at the D. R. I heard it for a number of months as you may know and some of these listeners may not the diabetes Research Institute is is really probably the premier organization in the world.
That has been experimenting with islet transplantation.
And they've been doing experiments and nonhuman primate models for decades.
With this therapy and so since the bio vascular pancreas is really an islet transplantation.
Delivery method or technology, we really we we view the partnership with the D. R. I S being a really important to our accelerator for for what we're going to be able to do because of their expertise in primate models, and immuno suppression and I love isolation et cetera et cetera.
With that being said I'm, a I think that.
I, you know again, I hate to predict but but I think that we will have updates on the on the BBB projects certainly are bought by the middle of next year, perhaps earlier, we have multiple work streams underway not just the work with the with the diabetes Research Institute, but also work with various stem cell line.
And various sources of islands that we would use them. The BCP so its a little bit like ducks feet underwater. We've got a lot going on and I would expect more updates probably in the next six to nine months.
Great great. Thanks, so much.
The next question is from Tanya.
Tanya with Oppenheimer. Please go ahead.
Good morning, Laura Dale can you hear me all right.
Yeah.
Yes.
Perfect.
A lot of questions have been asked on V O five.
Curious.
Conditions for humanitarian use.
As I understand it they usually different than.
And that's in a clinical trial setting. Please correct me, if I'm wrong and I'm just.
Curious if at this but this would be kind of apples and oranges.
To reach the end is equal to 75.
So.
So I hear what you're saying Suraj, let me try to clarify a little bit more so as as you may be aware that the human site H a V for the trauma indication.
Qualifies for an accelerated approval pathway.
And what.
What the what the F. D. A typically specifies is that an accelerated approval pathway.
Or in single arm trials, they often look for confirmatory information either from other clinical trials or from laboratory based studies et cetera, et cetera, or even other indications.
So the humanitarian data in Ukraine.
Fall into the category of a confirmatory or supporting data, they're not primary clinical trial data in the V. O. Five trial. However, the because actually the patients who are receiving humanitarian use of the H a V actually fall under the inclusion in <unk>.
Excluding criteria.
That we've applied for for the V O five trial. So we they have the same types of injuries. These are injuries to the arteries in the limbs with arteries of a certain diameter. That's addressable by the H a V etcetera, etcetera, so actually the comparability of the patients and the clinical use scenarios is higher than you might.
Think although I will say that the complexity of the injuries and the contamination level of the injury.
In Ukraine is actually probably worse than the U S. Because a lot of these patients have shrapnel and mine blast injuries that are that are fairly horrific. So so from our conversation with the FDA that they view the Ukraine data you know not as equivalent to the V O five data, but as strongly supportive.
And indeed, they they view it they view success clinical success in Ukraine is sort of meeting a higher bar.
Then than a clinical trial site in the U S. A because it's a more austere environment.
Got it and Laura a couple of questions on the on the Fresenius and the EV fistula part of the equation.
600000 patients being analyzed laurel.
You know maybe you can give some parameters in terms of what specific criteria being used and how many of those potentially could be candidates.
For HIV and on the same token Dale if I could just throw in one question you'll wait.
Maybe you can help us understand about $171 million in and.
A lot of stuff going on in the Fresenius side of the equation just characterize where you are in.
In terms of Fresenius has a relationship with humor site. Thank you for taking my questions.
So suraj I'll I'll start off with the for Nova research, So as I've mentioned on previous calls.
This is this is an exciting project that we're doing with them, but it's a big project, obviously 600000 patients in the U S and Europe .
What what were the types of data. We're obtaining you know what I included in the in our remarks and in our press release, we're really trying to understand with respect to access dialysis access per say, who are the patients who have essentially repeated problems with their access.
Are the patients who.
Kevin access placed initially, but then who see multiple failures or see multiple infections with their access or whose whose official has never mature until theyre left with catheter and then their catheters become infected and really the question that we're asking with with for Nova is what is the profile of a patient.
Who is very likely to have multiple problems with their access and multiple failures. So for example, if you're a 75 year old diabetic women and if you're being considered for officially.
The data may tell us from for Nova that statistically a 75 year old diabetic women is very unlikely to mature her official and is likely to have three hospitalizations from sepsis and so you probably shouldn't go that route.
And it's it's really a different kind of data analysis than has ever been done in this field.
Certainly the U S. R. D S never analyzes data in this way.
But it's it's really a patient centric approach to identify patients who have the type of patient who has the most trouble with their access because we believe that that that is the patient population, who really may benefit from the from the rapid usability for dialysis and the low infection rate of the H E B.
So how many of those you know what fraction of those 600000 patients you know, it's it's hard to know right now because we're still deep in the analysis.
But again, our prior guidance as far as a market capture has been about 20% of the total market you know at full market penetration. So it's still a fairly conservative assessment.
You know again, there are data out there that says that women and particularly older women or diabetic women or the elderly in general tend to not mature their fistulas and tend to spend a lot of time on catheter. So if I were to guess I would say it's that segment.
That will most benefit from the HIV, but the beauty of this project is that it's going to allow us to have very hard quantitative numbers that we think will be compelling for insurers and and health care providers and hospitals.
Yes, Suraj. This is Ed deal with regards to your second question around the vignettes you you may have been referencing some of the recent.
Recent leadership changes as well as structural changes within Fresenius.
Regardless of those events, we certainly don't see any lack of enthusiasm or change in the enthusiasm level its resilience for the JV and the potential impact it.
Hum.
It promises with regards to the care of Avx's patients, including improving patient outcomes and as Loren for tender for Novo Research also provided me.
Cost savings in the treatment of the.
If appropriate patients that are targeted so.
We continue to work very closely with them and I can tell you that where.
We're still high on their priority list.
New leadership with them.
Presenting says actually visiting our offices next month to a tour facilities. So the relationship continues a strong as it's ever been.
Thank you.
The next question is from Bruce Jackson with the Benchmark Company. Please go ahead.
Hi, Good morning, and thank you for taking my question.
I wanted to start with the piece of enrollment for the easy access to all of these user of southern trials. So last year I think you were some last year last quarter.
There was someplace around 222 patients.
That 227 this quarter.
Given that sort of five to six patients per quarter pace and extrapolating. It out it looks like you've got maybe two to three more quarters of enrollment to go.
So maybe you could talk to us about the pace of enrollment in that trial and is there any anticipated changes here going forward.
Yeah. So I think that last quarter was a disappointingly slow it certainly was slower last quarter than we've seen in other quarters and I'm I'm not sure that that's representative.
You know I think that we have we have had a follow on meetings with many of our high enrolling investigators and we've we've activated activating several new sites in the trial with a lot of sort of new investigator enthusiasm.
You know part of the slowdown last quarter may have been.
Just think investigator fatigue, you know this trial has been going on throughout Covid and and it's just it's been a tough trial to enroll because this is a this is a sort of an elective.
Elective surgical population that sort of cycled in and out of care during during the Covid pandemic and all the lockdowns.
So again I'm I'm, hoping that that it's certainly not going to take several more quarters are you know the the number of patients that we're planning to enroll is approximately 240.
So it could be a few more could be a few less and again all I can say is that we're very we're very close and we're leaning into it very hard.
Okay, great Great and then once you've completed the follow up and data analysis I'm, assuming that the the turnaround to a filing.
With the FDA as can be fairly quick.
Well it depends on what the results are.
As always but but yes, we would you know this would be an amendment.
To the BLA, presumably by the time, we filed a dialysis access indication we would already have.
The trauma indication in place and granted.
And Ah the certainly the manufacturing components and the preclinical components and the quality components of the BLA for <unk> for the dialysis indication would be identical to what has already been filed and trauma. So it's really it really comes down to a summary of the clinical trials. So so you're right the the hurdles.
Filing a BLA.
I'm, assuming that the outcomes from V O seven are or what we're hoping that timeline could definitely be a shortened but again, we're still enrolling Bruce and you know I'm I'm not going to be the one to say I know what the outcomes are.
Okay, Okay great.
And then a quick question for deal on the operating expense profile here going forward. So.
Yes, we're looking toward 2023 should we be taking the current operating expense for the quarter and kind of.
Kind of like moving that forward and then how do you see that profile changing over the course of 2023 as you wrap up the the Mark you down.
Expenses for the product launches.
Yeah, you know Bruce you you're right, we are going to as we get closer to you know what.
Mid 2023 filing that.
So its approval.
Some period of time after that you can talk about.
The estimates of what it would take to go through the BLA process, but.
Yeah.
Relevant point in time produce you.
Ramp up in commercialization expenses.
Those come.
Near time of approval.
Bringing onto the sales force.
That's a little later in the process.
Some of them.
Some of the other players on the marketing side that came in earlier.
But that being said you know when we talked about.
Miniatures in 'twenty, 'twenty, three and 'twenty 'twenty four.
The level of expenditures not set and shouldn't be somebody at our discretion.
You're right in the commercialization expenses will increase.
But certain other clinical trial expenses will be winding down such as B O five seven during that timeframe.
So the actual ultimate burn rate is going to be somewhat dependent upon.
Our election in terms of how quickly we've moved certain programs.
Expand our our pipeline, particularly with more advanced stage clinical development of some of the earlier stage programs.
Part of that determination.
You know to be honest with you based on market conditions, and how things are flowing at that point in time.
Clearly, we have the cash on hand to get past.
A major value inflection points the rate, we're spending right now.
From today, we've got about 2.4 years of cash on hand.
I also believe we've got meaningful debt capacity available to sort of.
Working capital requirements or requirements associated with the launch.
But.
We're not going to draw a line in the sand right now in terms of what the expenditure levels are going to be for.
For 2023, because it's part of it's going to be based on.
Our discretion, depending upon whats happening and happening in the world as we move into that year.
Okay got it. Thank you very much for taking my questions.
You're welcome next question.
Sorry, the last question from Ryan.
D G. I G. Please go ahead.
Hey, good morning, Thanks for taking the questions I apologize if I missed this Laura but did you given the enrollment pace for V. O. Five when do you expect top line data ahead of.
Putting together the BLA submission.
So yes, we didn't cover that and so that that is a good question.
The position of the F. D. A AR continues to be the same that because we're on this accelerated approval pathway that it's really 30 day patency primary patency that will be the primary endpoint in this trial and and other endpoints such as patient survival and limb salvage will be second.
Gary endpoints. So because this is a single arm open label.
Trial, and because and because we've been following all along.
Once the last patient hits their 30 day end point, you know we will have top line results in hand.
So I think that the the the time delta between when we finish enrolling and and when we have top topline results will be short and again also because of this and because much of our BLA in terms of manufacturing has already been submitted to our I N D. We.
Think that the time between when we finish enrolling and when we file the BLA will only be a couple of months it'll be pretty quick.
Yes, no that makes sense and I would assume that.
You know similar to other submissions a lot of that a lot of it's already done and it's really this last clinical piece that you're waiting on just just as an aside.
No you are bringing on the Israeli sites are those enrolling at this point those Israeli sites. Obviously numbers are the patient numbers are where they're at but are they actively up and running at this stage.
They're actively up and running in fact, we had a we had a visit from one of our operations people to Israel just last week, our Israel has not enrolled as of yet, but we anticipate that they will.
Okay. That's very helpful. And then last one for me just you know.
What commercial activities are you guys preparing for when you think about V O five and getting the BLA ready you know you have started to make some hires on the commercial side with a D. J and so I was curious kind of what commercial activities are you preparing for at this stage.
As you think about V O five eventually making it to market.
Yeah.
Oh go ahead go ahead, well no I'll, just I'll, just say a little bit Dale I mean, certainly we have P. J and we're building out the clip, but clinical that the commercial team in terms of marketing we have some staff onboard as far as health economics.
And we're looking at growing the team in terms of market access. We've also been using a lot of third party vendors to do market analysis for us to look at price sensitivity and the scenarios. According to hospitals and health care providers as far as where they think the H a V would be most useful.
In trauma. So again, a lot of that has been like ducks feet underwater and it hasn't represented hires per se because a fair bit of this work has been outsourced but were actually fairly far down the path as far as analyzing in the market.
By virtue of these are third party vendors, but I'll, let I'll, let Dale continue.
No I think you are actually covered at all or.
Yeah.
Okay.
Thank you I'm showing no further questions.
This concludes the third.
Third quarter results conference call.
Participating.
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[music].
Yeah.
Yeah.
[music].
Okay.
[music].
Yeah.
Yes.
[music].
Yeah.
[music].
Yeah.
[music].