Q1 2022 Humacyte Inc Earnings Call
Good morning, ladies and gentlemen, and welcome to the human side first quarter 2022 results conference call.
Good morning, ladies and gentlemen, and welcome to the human site first quarter 2022 results conference call. Currently all participants are.
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. If anyone should need operator assistance during the conference, please press star 0 on your telephone key.
Later, we will conduct a question and answer session and instructions will follow at that time.
What you need operator assistance during the conference. Please press star zero on your telephone keypad.
As a reminder, this conference call is being recorded. I will now turn the call over to Laura Marik with Plightside Advisors. Please go ahead.
As a reminder, this conference call is being recorded.
I will now turn the call over to Laura Merrick with pipe side Pfizer's. 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 loss. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.
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 any 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.
Any 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 thereof, and the company undertakes no obligation to update or revise the forward-looking statements except as required by law.
Word 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.
Information presented on this call is contained in the press release we issued this morning and in our form 10Q which will be filed today and may be accessed from the investors page of the Humasite website.
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 human side website joining.
Joining me on today's call from Humasite are Dr. Laura Nicholson, President and Chief Executive Officer, Dale Sander, Chief Financial Officer and Chief Corporate Development Officer, and Dr. Heather Pritchard, Chief Operating Officer. Dr. Nicholson will provide a summary of the company's progress during the quarter and recent weeks before turning it over to Dale for a review of the company's financial results.
Joining me on today's call from Hemocyte, our Doctor, Laura Nicholson, President and Chief Executive Officer.
Bill Sander, Chief Financial Officer, and Chief Corporate Development Officer, and Doctor Heather Pritchard, Chief Operating officer, Dr. Nicholson will provide a summary of the companys progress during the quarter and recent weeks before turning it over to Dale for a review of 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 Dr. Nicholson.
Following their prepared remarks, the management team will be available for your questions I will now turn the call over to Dr. Nicholson.
Thank you Lauren good morning, everyone and thank you for joining us.
Thank you, Lauren. Good morning, everyone, and thank you for joining us. We appreciate your attendance today.
We appreciate your attendance today.
I'll just briefly summarize our recent highlights before turning the call over to Dale for a review of the financials for our first quarter.
I'll just briefly summarize our recent highlights before turning the call over to Dale for a review of the financials for our first quarter. Again we'll be happy to open up.
Then we'll be happy to open up the call to your questions.
I'm pleased to report that we had a productive first quarter marked by continued progress advancing our universally implantable bioengineered human tissue platform.
I'm pleased to report that we had a productive first quarter marked by continued progress advancing our universally implantable bioengineered human tissue platform.
We believe our lead candidate, the HAZ, is uniquely suited for scenarios in which the current standard of care is either unavailable or is inadequate.
We believe our lead candidate the H N V is uniquely suited personnel goes in which the current standard of care is either unavailable or is inadequate.
This week, we were proud to announce a new initiative in which we are providing our HIV to frontline hospital in Ukraine for the treatment of military and civilian vascular common injuries that are resulting from the crisis in the region.
This week we were proud to announce a new initiative in which we are providing our HAVs to frontline hospitals in Ukraine for the treatment of military and civilian vascular trauma injuries that are resulting from the crisis in the region.
During the quarter, we also strengthened our team with the appointment of Dr. Shamik Parikh as our chief medical officer.
During the quarter, we also strengthened our team with the appointment of doctors Kmiec Perique as our Chief Medical Officer Dr.
Dr. Priest joins us at a pivotal time as we look forward to anticipated completion of our late-stage clinical trials in vascular trauma and arterial venous access for hemodialysis.
Dr. Craig joins us at a pivotal time as we look forward to antiques to anticipated completion of our late stage clinical trials and vascular trauma and arterial venous access for hemodialysis.
And if approved.
as we endeavor to bring the HAV to market for our initial indication.
As we endeavor to bring the H a V to market for our initial indications.
I'll first begin with our announcement earlier this week of a new initiative to provide our HAVs to multiple hospitals in Ukraine for the treatment of wounded civilians and soldiers who are suffering from vascular traumatic injuries.
I'll first begin with our announcement earlier this week of a new initiative to provide our HIV to multiple hospitals in Ukraine for the treatment of wounded civilians and soldiers who are suffering from vascular traumatic injury.
This initiative began as a request from one Ukrainian surgeon who was familiar with our technology and requests from Ukraine quickly grew to include other surgeons and hospitals around the country.
This is this initiative began as a request from one Ukrainian surgeon, who was familiar with our technology.
And requests from the Ukraine quickly grew to include other surgeons and hospitals around the country.
Six hospitals in Kiev, khaki and other cities will be the recipients of our initial shipment.
Six hospitals in Kiev, Kharkiv, and other cities will be the recipients of our initial shipment.
We continue to receive requests from local surgeons for the product candidate and we plan to coordinate shipments to additional hospital sites as soon as possible.
We continue to receive requests from local surgeons for the product candidate and we plan to coordinate shipments to additional hospital sites as soon as possible.
In launching this initiative human flight worked with the office of international programs within the U S food <unk> drug administration as well as with the Ukraine Ministry of health to coordinate the export and import of our investigational HIV for humanitarian use.
In launching this initiative, Humasite worked with the Office of International Programs within the U.S. Food and Drug Administration, as well as with the Ukraine Ministry of Health, to coordinate the export and import of our investigational HAV for humanitarian use.
While this humanitarian effort is outside the scope of the company's ongoing trauma trial. We expect that this program will provide additional real world evidence of the potential impact of the H a V in the treatment of vascular traumatic injuries.
While this humanitarian effort is outside the scope of the company's ongoing trauma trial, we expect that this program will provide additional real-world evidence of the potential impact of the HAV in the treatment of vascular traumatic injuries.
As a company humus like it's very proud to contribute to the ongoing medical relief efforts in Ukraine and to support the patients and the brave medical practitioners on the ground during this humanitarian crisis.
As a company, Humasite is very proud to contribute to the ongoing medical relief efforts in Ukraine and to support the patients and the brave medical practitioners on the ground during this humanitarian crisis.
I'm immensely grateful to the Humasite team for their tireless work seeing this through, as well as to the surgeons in Poland and in the US who have extensive experience with the HAV and who have volunteered to assist in training Ukrainian surgeons in the use of the product candidate.
I'm immensely grateful to the human side team for their tireless work seamless through as well as to the surgeons in Poland in Poland and in the U S who have extensive experience with the H a V and who have volunteered to assist in training and Ukrainian surgeons and their use of the product candidate.
Moving on to a broader platform for HIV and vascular trauma, our phase two three clinical trial is continuing to progress.
Moving on to our broader platform for HAV and vascular trauma, our Phase 2-3 clinical trial is continuing to progress.
As a reminder, this trial is a single-arm, non-randomized, open-label study, evaluating the use of HAVs for vascular repair, reconstruction, and replacement in traumatic injury settings.
As a reminder, this is a trial. This trial is a single arm non randomized open label study.
Evaluating the use of H a V for vascular repair reconstruction and replacement.
In traumatic injury settings.
We're pleased with the results from this study to date showing low rates of infection at approximately 2%.
We're pleased with the results from this study to date showing low rates of infection at approximately 2%.
We've also had no reports of limb amputation that occurred as a result of HAZ malfunction.
We've also had no reports of limb amputation that occurred as a result of H S email malfunction.
and we've observed very high patency of the conduit to date.
And we've observed very high patency of the conduit to date.
Results from the trial are expected later this year and we believe these results will support our planned BLA filing with the FDA, which we intend to submit by the end of 2022 or early 2023.
Results from the trial are expected later this year, and we believe these results will support our planned BLA filing with the FDA, which we intend to submit by the end of 2022 or early 2023.
We continue to progress in our discussions with the FDA about the trial design and the required number of subjects to be enrolled. You'll recall that the FDA has granted accelerated approval pathway for HAVs in this indication.
We continue to progress in our discussions with the FDA about the trial design and the required number of subjects to be enrolled.
You'll recall that the FDA has granted accelerated approval pathway for <unk> in this indication.
The H a V was the subject of multiple presentations at scientific conferences and journal publications during the first quarter.
The HAV was the subject of multiple presentations at scientific conferences and journal publications during the first quarter.
Results from a case study of a patient who received the HAV as a replacement for a synthetic infected allelephemeral bypass graft were published in the Journal of Vascular Surgery Cases and Innovations and Techniques.
Results from a case study of a patient who received the HIV as a replacement for synthetic.
Infected ileal femoral bypass graft were published in the journal of vascular surgery cases innovations and techniques.
In this case, at 22 months post-implantation, the patient had resumed regular physical activity and had no signs of infection of the HAZ implant.
In this case at 22 months post implantation, the patient had resumed a regular physical activity and have no signs of infection of the HIV implant.
In a first U.S. case series that was published, surgeons from the Uniformed Services University of the Health Sciences and Walter Reed National Medical Center reported on the first eight FDA-approved expanded access cases using the HAV for treatment of critical limb ischemia or vascular trauma.
In the first U S case series that was published surgeons from the uniformed services University of the Health Sciences, and Walter Reed National Medical.
<unk> reported on the first eight F. D. A approved expanded access cases, using the H a V for treatment of critical limb ischemia or vascular trauma.
In this case series, the HAV was observed to resist infection and to provide reliable patency and also offered surgeons an immediately available biological conduit.
In this case series the HIV was observed to resist infection and to provide reliable patency and also offered surgeons and immediately available biological conduit.
The report of this case series was published last month in the April edition of the Annals of Vascular Surgery.
The report of this case series was published last month in the April edition of the Annals of vascular surgery.
And finally, we're looking forward to the planned presentation of new HAV clinical immunogenicity data, reporting on blood work from patients who have received the HAV during a presentation at the American Transplant Congress that will be taking place in June of 2022 in Boston.
And finally, we're looking forward to the play and presentation of new HIV clinical Immunogenicity data reporting on blood work from patients who have received the HIV during our presentation at the American transplant Congress that will be taking place in June of 2022 in Boston.
The presentation will be delivered during the Bioengineering and Transplantation, Where Are We and Where Are We Going session on June 8th at 7 a.m. Eastern Time.
The presentation will be delivered during the bioengineering and transplantation, where are we and where are we going session on June eight at seven a M eastern time.
This talk will provide quantitative insights into the patient responses and tolerance of the HAV when implanted in various clinical indications.
This shock will provide quantified quantitative insights into the patient responses and tolerance of the HIV when implanted in various clinical indications.
Turning now to our development program of HAVs for arteriovenous or AV access in hemodialysis patients.
Turning now to our development program of H a vs four arteriovenous or a V access in hemodialysis patients.
Our enrollment in our phase III trial is nearing completion.
Enrollment in our phase three trial is nearing completion.
This trial is designed to assess the usability of the HAV for dialysis in comparison to autogenous fistulas in up to 240 patients with end-stage renal disease. We expect enrollment to be complete.
This trial is designed to assess the usability of the H a V for dialysis and comparison to autogenous fistulas in up to 240 patients with end stage renal disease.
We expect enrollment to be completed later this year.
Based on the one-year follow-up period built into the study, we anticipate top-line results in 2023, followed by a BLA filing for the dialysis indication.
Based on the one year follow up period built into the study we anticipate topline results in 2023.
Followed by a BLA filing for the dialysis indication.
Five year data from our phase two clinical trial of patients receiving the H a V for dialysis access were published in the Journal E. J D S vascular form.
Five-year data from a Phase II clinical trial of patients receiving the HAV for dialysis access were published in the journal EJVES Vascular Forum.
Results showed long-term durability and usability of the HAV during the five-year follow-up period, with no reports of infection or immunogenicity.
Results showed long term durability and usability of the H a G. During the five year follow up period.
With no reports of infection or Immunogenicity.
As we progress toward commercialization, we look forward to building upon our strong relationship with our global partner and shareholder Fresenius Medical care.
As we progress toward commercialization, we look forward to building upon our strong relationship with our global partner and shareholder, Fresenius Medical Care.
Fresenius is the global leader in kidney care services, products, and value-based care.
For Sunniest as the global leader in kidney care services products and value based care.
and it's also providing valuable market insights and commercial launch advantage.
And it's also providing valuable market insights and commercial launch advantages.
We're partnering with Fresnova, a clinical research group owned by Fresnian.
We're partnering with for Nova a clinical research group owned by Fresenius.
to evaluate the cost of hemodialysis access care for vulnerable patients in both the U.S. and Europe .
To evaluate the cost of hemo dialysis access care for vulnerable patients in both the U S and Europe .
These evaluations will assist us with development of health economic models and value propositions for the HAV in patients with kidney failure.
These evaluations will assist us with development of health economic models and value propositions for the H a V in patients with kidney failure.
Finally, we're also continuing to make progress in our earlier portfolio programs and other indications.
Finally, we're also continuing to make progress in our earlier portfolio programs and other indications.
The expanded access program for HAVs in patients with emergency vascular conditions.
The expanded access program for <unk> in patients with emergency vascular conditions.
such as severe peripheral arterial disease continues to progress.
Such a severe peripheral arterial disease continues to progress.
To date, we've implanted roughly 20 patients in the US under this program and the outcomes of the first date cases were highlighted in a presentation in January .
To date, we've been planted roughly 20 patients in the U S. Under this program.
And the outcomes of the first eight cases were highlighted in our presentation are in January .
In addition, enrollment of patients in the Mayo Clinic's investigator-sponsored study of HAVs for the treatment of severe PAD is advancing. And we anticipate providing an update on this study later this year.
In addition enrollment of patients in the Mayo clinics investigator sponsored study of H a V.
For the treatment of severe P. E D is advancing and we anticipate providing an update on this study later this year.
With respect to our preclinical programs, in January we presented positive results from our first preclinical study of our small diameter HAVs for use in coronary artery bypass grafting or cabbage. This presentation was at the Advanced Therapies Week in January .
With respect to our preclinical programs in January we presented positive results from our first preclinical study of our small diameter hiv's for use in coronary artery bypass grafting or cabbage. This presentation was at the advanced therapies week in January .
In this study the HIV was observed to maintain patency and exhibited host remodeling as well as regeneration in a nonhuman primate model.
In this study, the HAV was observed to maintain patency and exhibited host remodeling as well as regeneration in a non-human primate model.
Thus highlighting the potential use of HIV and coronary artery bypass grafting.
thus highlighting the potential use of HAVs in coronary artery bypass grafts.
In addition, we continue to be encouraged by our efforts in developing HAVs as complex organ systems.
In addition, we continue to be encouraged by effort by our efforts in developing H a vs as complex organ systems.
Our biovascular pancreas, or BVP, is an HAV that is coated with islets and designed to deliver insulin to type 1 diabetics.
Our bio vascular pancreas or B V. P is in HIV that is coated with islets and designed to deliver insulin to type one diabetics.
BVP results in a diabetic rodent model were published last year in the Journal of Tissue Engineering and we're currently moving forward into large animal preclinical studies of this exciting program.
B V. P results in a diabetic rodent model were published last year in the journal of tissue engineering.
And we're currently moving forward into large animal preclinical studies of this exciting program.
As far as other corporate updates as I mentioned earlier last month, we were pleased to announce the appointment of Shumeet Shea Perique M D as our Chief Medical Officer.
As far as other corporate updates, as I mentioned earlier, last month we were pleased to announce the appointment of Shamik J. Parikh M.D. as our Chief Medical Officer.
In his new role, Dr. Parikh will lead our global clinical development strategy, including oversight of the preclinical and clinical development, clinical operations, and medical affairs functions.
His new role Dr. Perique will lead our global clinical development strategy, including oversight of the preclinical and clinical development clinical operations and medical affairs functions.
Dr. Parikh brings to us more than two decades of leadership experience in academia, the NIH, and at global pharmaceutical companies, including his 16-year tenure at AstraZeneca.
Dr. <unk> brings to us more than two decades of leadership experience in academia.
I H and a global pharmaceutical companies, including his 16 year tenure at Astrazeneca.
Dr. Perique has led clinical research and development, product launches, medical affairs and drug safety across multiple therapeutic areas. We're very pleased to have Dr. Perique with us and we're looking forward to adding his insights and expertise to the human site team.
Dr. Perique has led clinical research and development product launches medical affairs, and drug safety across multiple therapeutic areas.
We're very pleased to have Dr. Perique with us and we're looking forward to adding his insights and expertise to the human site team.
And with that, I'll turn it over now to Dale for a review of our financial results and for other business developments.
And with that I'll turn it over now to Dale for a review of our financial results and for other business developments.
Thank you Laura.
As of March 31, 2022.
As of March 31, 2022, we had cash, cash equivalents, and short-term investments of $206.2 million.
Cash cash equivalents and short term investments of $206 2 million.
compared to $225.5 million at December 31, 2021.
Third to $225 5 million at December 31, 2021.
The 19.3 million net use of cash, cash equivalents, and short-term investments for the first quarter of 2022 resulted from spending related to net operating activities for the quarter, including our clinical and earlier stage R&D programs and preparation for our anticipated commercial line.
The $19 3 million net use of cash cash equivalents and short term investments for the first quarter of 2022.
Resulted from spending related to net operating activities for the quarter, including our clinical and earlier stage R&D programs in preparation for our anticipated commercial launch.
We believe that our current cash position is adequate to fund operations through the end of 2024, past our current expected timelines for potential approvals of the HAB in vascular trauma and AB access for hemodalysis.
We believe that our current cash position is adequate to fund operations through the end of 2024.
Our current expected timelines for potential approvals of the HIV and vascular trauma and access for hemodialysis.
Revenue for the first quarter of 2022 was $233,000, compared to $155,000 for the first quarter of 2021. Revenue for both periods was related to grants supporting the development of the HAB.
Revenue for the first quarter of 2022 was 233000 compared to 155000 for the first quarter of 2021 Red.
Revenue for both periods was related to grants supporting the development of the HIV.
Research and development expenses were $16.3 million for the first quarter of 2022 compared to $15.1 million for the first quarter of 2021.
Research and development expenses were $16 3 million for the first quarter of 2022 compared to $15 1 million for the first quarter of 2021.
Current quarter increase resulted primarily from increased personnel and material expenses designed to support expanded research and development initiatives and the support of our clinical trials.
The current quarter increase resulted primarily from increased personnel and material expenses.
And to support expanded research and development initiatives.
The support of our clinical trials.
general and administrative expenses were $5.7 million for the first quarter of 2022 compared to $4.8 million for the first quarter of 2021.
General and administrative expenses were $5 7 million for the first quarter of 2022.
Compared to $4 8 million for the first quarter of 2021.
The current quarter increase resulted primarily from the transition to being a public company in preparation for the planned U.S. commercial launch of the HAB, if approved.
The current quarter increase resulted primarily from the transition to being a public company in preparation for the planned U S. Commercial launch of the HIV if approved.
including increased personnel costs, professional fees, and insurance costs.
Including increased personnel costs professional fees and insurance costs.
Other net income was $1.9 million for the first quarter of 2022 compared to net expense of $0.5 million for the first quarter of 2021.
Other net income was $1 9 million for the first quarter of 2022.
Third two net expense.
$5 million for the first quarter of 2021.
The current year increase and other net income resulted primarily from non-cash gains related to the re-measurement of the contingent earn-out liability associated with the August 2021 merger with the Alpha Healthcare Acquisition Corps.
The current year increase in other net income resulted primarily from noncash gains related to the remeasurement of the contingent earn out liability.
Associated with the August 2021 merger with Alpha Healthcare acquisition Corp.
These gains were partially offset by an increase in interest expense related to our loan facility with Silicon Valley Bank.
These gains were partially offset by an increase in interest expense related to our loan facility with Silicon Valley Bank.
Net loss was $19.8 million for the first quarter of 2022.
Net loss was $19 8 million for the first quarter of 2022.
Paired to a net loss of $20 3 million for the first quarter of 2021.
The current quarter decrease in net loss resulted from the increase in other income described earlier.
Partially offset by expense increases also described earlier.
With that, I'll turn it back over to Laura for concluding remarks.
With that I'll turn it back over to Laura for concluding remarks.
Thank you Dale to conclude 2022 is off to an exciting start.
We launched an important new initiative to assist the Humana humanitarian crisis in Ukraine with our HIV technology.
and we have continued to advance our HAZ platform in both clinical and preclinical programs.
And we have continued to advance our HIV platform in both clinical and preclinical programs.
We also strengthened our leadership team with the appointment of Dr. <unk> Creek as I'm, the CMO and.
And we have a strong balance sheet with anticipated cash runway to carry us through significant value inflection points.
Operator, we're ready to take questions.
Thank you we will now be conducting a question and answer session. We would like to ask a question. Please press star one on your telephone keypad.
The confirmation zone will indicate your line is in the question queue. You may press star 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 key. One moment, please, while we poll for your question.
Information Paul educate your line is in the question queue.
You May press Star 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 Q1 moment. Please while we poll for your questions.
Our first questions come from the line of Ryan Zimmerman with <unk>. Please proceed with your question.
Our first questions come from the line of Brian Zimmerman with BTIG. Please proceed with your question.
Good morning. Thanks for taking the questions. Hope you're doing well and congrats on the progress.
Hi, good morning, Thanks for taking the questions hope Youre doing well and congrats on the progress.
Wanted to start with both the V O five trial and will be Oh seven trial.
I want to start with both the VO5 trial and the VO7 trial.
I think last quarter, the VO5 trial was sitting at 50 plus patients enrolled. I believe you only need 40, and so I want to just understand kind of, you know, what you need to, you know, officially complete enrollment there before submitting. And then I think AV Access, the VO7 trial, I think, again, you are at 210 last quarter, you need 240, so kind of where you stand in.
I think last quarter. The V O five trial is sitting at 50 plus patients enrolled.
I believe you only need 40, and so I wanted to just understand kind of.
What you need to.
Officially complete enrollment there before submitting and then I think Avi access.
Seven trial I think again you were at 210 last quarter you need to 40, so kind of where are you standing.
There and if we were to hone in on.
There and if we were to hone in on, you know, enrollment for those two trials in terms of timing, that'd be helpful. Thank you.
Enrollment for those two trials in terms of timing that'd be helpful. Thank you.
Ryan This is Lori necklace and thanks very much for those questions.
Ryan, this is Lauren Eccleston. Thanks very much for those questions. So, with regard to VO5, which is our single-arm trauma trial, we've continued to enroll at the rate of a couple patients per month, one or two patients per month, which has been sort of our standard. We are obviously efforting increase in enrollment rate. Currently, I think we sit around 54 patients, although I'm not completely sure, but I think that's roughly the right number.
So with regard to V O five which is our single arm trauma trial.
We've continued to enroll at the rate of a couple of patients per month, one or two patients per month, which has been part of our standard.
We are we are obviously efforts increasing enrollment rate currently I think we sit around 54 patients, although I'm not completely sure, but I think that's roughly the right number.
With regard to the 40 number that you mentioned earlier, the guidance that we've given to the street so far is that we anticipate needing roughly 70 or 75 patients.
With regard to the 40 number that you mentioned earlier the guidance that we've given to the street. So far is that we anticipate needing a roughly 70 or 75 patients in total.
in total to have a sufficient number of evaluable patients for the FDA to accept the BLA. We are continuing discussions with the FDA, and we're actually making progress on those discussions and nailing down this number. So we continue to feel confident that the timelines that we've been communicating so far, as far as having enough patients,
A sufficient number of evaluable patients.
For the F D a to.
To accept the BLA.
We are continuing discussions with the FDA and we're actually making progress on those discussions and nailing down. This number. So we continue to feel confident that the timelines that we've that we've been communicating so far as far as having enough patients and completing enrollment by the end of this year.
completing enrollment by the end of this year, we continue to give that guidance. But I can't give you any more specifics.
We continue to give that guidance, but I can't give you any more specific numbers at this time.
with respect to dialysis access, you're right. I think maybe at the last call we were around 210, I can't remember. I think right now we're around 220 patients. Enrollment is picking up a little bit now that COVID restrictions have been pulled back over the last month or two in many, in many locations. So again, we continue to give the same guidance that we anticipate completing enrollment later this year.
With respect to dialysis access.
Youre right I think maybe at the last call. We were around 210, I can't remember I think right now we're around 220 patients enrollment.
Enrollment is picking up a little bit now that COVID-19 restrictions have been pulled back over the last month or two.
In many in many locations.
Again, we continue to give the same guidance that we anticipate completing enrollment later this year.
And then would have topline results.
and then would have top line results sometime perhaps mid to, you know, third quarter of 2020.
Some time, perhaps.
Mid to <unk>.
Third quarter of 2023.
Got it. Very helpful, Laura. Thank you. And then, yeah, I must have mistaken on the 40. On the immunogenicity data, what should we be looking for?
Got it very helpful. Thank you and then.
Yes.
I must be mistaken on the 14th.
On the Immunogenicity data what should we be looking for.
So as we've as we've given guidance to.
So, as we've given guidance to our analysts and our investors previously, we have to date we've seen no evidence of immunogenicity, clinical immunogenicity in any patient that we've studied. However, we've never reported these results in terms of specific blood work outcomes and really more nitty-gritty clinical details. And so, the
To our analysts and our investors previously we have we have to date, we've seen no evidence of Immunogenicity.
Clinical immunogenicity in any patient.
That we've studied them. However, we've never reported these results in terms of specific bloodwork outcomes and really more nitty gritty clinical details and so the the focus of the talk that we'll give in June at the American transplant Congress.
the focus of the talk that we'll give in June at the American Transplant Congress.
really is providing the scientific underpinning and the blood work details around those data. The overall message is going to remain the same, but I can't share any more details now in advance of the presentation.
It really is providing the scientific underpinning in the blood work details around those data. The overall message is going to remain the same but I can't share any more details now in advance of the presentation.
Understood. Thanks for taking the questions.
Thank you. Our next questions come from the line of Siraj Kalia with Oppenheimer. Please proceed with your question.
Thank you. Our next question is coming from the line of Suraj Kalia with Oppenheimer. Please proceed with your question.
Good morning, Laura Dale can you hear me all right.
Yes.
Perfect.
Perfect. Hey, so Laura, in terms of the 005 and 007 trials, just the length of the trials given COVID and everything, should we anticipate any sort of confounders when the enrollment is done and the data is presented?
So Laura in terms of.
The all five or seven trials, just the length of the trials given COVID-19 and everything should.
Should we anticipate any sort of founders.
The enrollment is done.
And the data is presented.
Yeah.
So, Seraja, I think I understand your question. I think you're asking, you know, whether just the increased duration in enrollment because of slowdowns to COVID, whether that's going to impact outcomes. You know, again,
So suraj I think I understand your question I think youre asking you know whether just the the increased duration and enrollment because of slow down because of COVID-19, whether that exactly what the impact outcomes.
You know it again.
It's a little hard to answer that question, because we don't we.
It's a little hard to answer that question because we don't have the alternative hypothesis, which is if we had rolled quickly, then what would that trial look like?
We don't have the alternative hypothesis, which is if we had rolled you know quickly then what what would that trial has looked like so it's it's a little speculative on my part but.
So it's a little speculative on my part, but I will say that in dialysis, it's well known that COVID, when it infects dialysis patients, is particularly lethal. The fatality rate is 20 to 30 percent in dialysis patients.
But I will say that in dialysis, it's it's well known that COVID-19 when it infects dialysis patients is particularly lethal.
The fatality rate is $20 to 30% in dialysis patients and we know we've had a number of COVID-19 infections. So so I think that the the number of deaths that we may see in the dialysis population, maybe a little bit higher but I don't think that's going to otherwise impact the efficacy of.
And we know we've had a number of COVID infections, so I think that
the number of deaths that we may see in the dialysis population.
may be a little bit higher, but I don't think that's going to otherwise impact the efficacy of the H3.
The HIV per se.
Got it Laura in terms of the the vascular trauma trial I know the discussions with the FDA have been ongoing for some time is this something specifically.
Got it. Laura, in terms of the Vascular Trauma Trial, I know the discussions with the FDA have been ongoing for some time. Is there something specifically that is, I shouldn't say a point of contention, but a point of negotiation, so to speak, in the endpoints, in the design, or anything, any additional color would be great. I appreciate it.
That is I shouldn't say a point of contention but a.
A point of negotiation so to speak and the endpoints.
In the design or art.
Anything any additional color would be greatly appreciate it.
Yes, I think, so you're right, these conversations have been going on for a while. I would say that we're advancing them well now, and I'm pleased with the progress.
Yes, I think so you're right. These are these conversations have been going on for awhile.
I would say that that we're advancing them well now and I'm pleased with the progress, but you know the points of discussion are really more around a total body of data both pre BLA and then potentially a.
But, you know, the points of discussion are really more around.
total body of data, both pre-BLA and then potentially
post-approval. So as we've mentioned, you know, the FDA has offered an accelerated approval pathway for the product.
Post approval. So as we've mentioned you know the FDA has offered an accelerated approval pathway for the product and so combined with that with any accelerated approval pathway is also a post approval commitment or requirements and and because because of the trauma population is so diverse.
And so combined with that, with any accelerated approval pathway, is also a post-approval commitment or requirement. And because the trauma population is so diverse, there's been a lot of discussions about the amount of data.
First there's been a lot of discussions about the amount of data that the FDA would like to see pre approval and then post approval. So that's that's really kind of the one of the major foci of our discussions.
that the FDA would like to see pre-approval and then post
So that's really kind of one of the major foci of art.
Okay that makes a lot of sense a great day.
Okay, that makes a lot of sense, agreed. Hey, Dale, you mentioned roughly 200 million on hand. Till you're in 24, everything should be kosher. So if I use the 25 million or close there off, burn this quarter straight line, I get it.
You mentioned.
Roughly $200 million on hand.
Till year end 'twenty four everything should be kosher.
I use the $25 million or close their off burn this quarter.
Straight line I get it.
If you could just drill down one more layer, when should the clinical spend start relatively taming off and when should the SG&A start ramping up still to effectuate a 25 million per quarter burn? And Laura, if I may just throw in one more, remind me the baboons in BVP, have we decided on the number of baboons? Folks, thank you for taking my question.
Dale if you could just drill down one more layer.
When should the clinical spend start tailing off relatively tailing off and when should the SG&A start ramping up.
Still to effectuate, a $25 million per quarter burn and Laura if I might just throw in one more remind me the baboons and.
Pvp.
You decided on the number of folks. Thank you for taking my questions.
So Dale, if you don't mind, I'll just answer the baboon thing, so we have not begun baboon work yet in the BVP work and it's too premature for me to talk about how many animals we would implant.
So Dale if you don't mind I'll just answer the baboons. Yeah. Go ahead, we have not we have not begun baboon work yet and in the BV P work and it's it's too premature for me to talk about how many animals, we would implant it's just too early.
Yes, Roger with regards to our cash burn I think if you were to take our.
Yes, Raj, with regards to cash burn, I think if you were to take our current year of financials and back out the non-cash expenses, I think we indicated the burn for the quarter was about $19 million, so you're right, there is a trail loss of the current clinical.
Current year financials and back out the non cash expenses I think we indicated the burn for the quarter was about 19 million. So.
Youre right Theres, a trail off will be critical.
Ah study expenses that we would expect would occur.
of study expenses that we would expect would occur in 2023.
2023.
I mean, clearly, there's a ramp on the commercialization side that will offset some of those declines. And part of that decision, in terms of the timing of those expenses, is strategic. You know, we already have our chief commercial officer on the line.
I mean, clearly there's a there's a ramp on the commercialization side that will offset some of those declines.
As part of that decision in terms of the timing of those expenses are strategic.
We already have our chief commercial.
Officer onboard.
Brought in.
but in resources in the areas of health economics and, you know, pay or management, which is, you know, long lead time items that is critical. And so certainly as we.
Resources in the areas of health economics and.
Power management, which is yes.
Long lead time items, so that's critical.
So certainly as we.
further define the timelines for expected approval in 2023 will bring on, start bringing on the infrastructure associated with the commercial group. The decision in terms of field sales reps, in terms of exactly when they come on is kind of a discretionary thought in terms of how far in advance or do you want to, especially higher than they had approval, but I think thinking about them coming on at about the time of approval is probably the best way to think about it.
Further defined the timelines for expected approval in 2023.
Bring on start bringing on the infrastructure associated with the commercial group.
The decision in terms of field sales reps in terms of exactly when they come on as is kind of a discretionary.
But in terms of how far in advance or do you Wanna, especially higher than that approval.
But I think thinking about them coming on at about the time of approval is probably the best way to think about it.
Thank you.
Thank you. Our next questions come from the line of Matthew O'Brien with Piper Sandler. Please proceed with your question.
Thank you. Our next question will come from the line of Matthew O'brien with Piper Sandler. Please proceed with your questions.
Maureen, thanks for taking the questions. Laura, can you just start with Ukraine and, you know, the number of HIVs you're expecting to be deploying over there, and are you able to charge for those, or is it just – are you just giving them to the government there, just based on the situation?
Good morning, Thanks for taking the questions.
Laura can you just start with Ukraine and.
The number of HIV as youre expecting it to be deploying over there and are you able to charge for those or is it just are you just giving them to the.
To the government there just based on the situation.
So thanks, Matt. Those are good questions. So we have no specific commitment going forward. We sent an initial batch of HAVs to six hospitals, and our intention is to look at the utilization and to understand what the clinical need is.
So thanks, Matt that those are good questions. So we have no specific commitments going forward, we sent an initial batch of HIV to six hospitals.
And our intention is to is to look at the utilization and to understand what the clinical need is as we make plans to make further shipments. So we don't have anything committed that's hard and firm, but we are committed to trying to help our Ukrainian civilians and military who.
as we make plans to make further shipments, so we don't have anything committed that's hard and firm, but we are committed to trying to help Ukrainian civilians and military who are suffering in this humanitarian crisis.
Our suffering in this humanitarian crisis.
As far as, oh gosh, I'm not sure I remember the second part
As far as Oh, gosh, I'm not sure I remember the second part of your question.
Just, do you get to charge for the HAVs that are going to pay you for them? We're not. We're not. You know, this product is not approved in the U.S. or in Europe , and we felt that it would not be appropriate to charge the Ukrainian government for this humanitarian
Do you get to charge for the for the yes.
We're not we're not you know with.
This product is not approved in the U S or in Europe , and we felt that it would not be appropriate to charge the Ukrainian government for this humanitarian assistance.
Okay, makes sense. And then, Dale, maybe a follow-up on Siraj's question. Now that Omicron has kind of fallen away, well, somewhat anyway, the R&D spend for the remainder of the year, how much should it ramp up? And then maybe I'll ask my last question up front here. Just the arrangement with Prasinius and the economic studies that you're doing. Can you just talk a little bit more about those?
Okay makes sense and then maybe a follow up on Suraj. This question.
Got it.
I'm, a chronic kind of fallen away well somewhat anyway.
The R&D spend for the remainder of the year, how much should it ramp up.
And then maybe I'll ask my last question upfront here, just the arrangement with Fresenius and the economic studies that you're doing.
Can you just talk a little bit more about those thanks.
Yeah, certainly, from an R&D expenditure point of view.
Yes, certainly from an R&D expenditure point of view with.
You know, we expect that to be relatively constant throughout the year. We are seeing some wind down and some of the clinical expenses that's been offset by a much more meaningful.
We expect that to be relatively constant throughout the year.
We are seeing some wind out of some of the clinical expenses.
Offset by a much more meaningful.
effort and activities that are underway this year with some of the preclinical efforts in the cabbage and in the PVP, so we end up with a relatively constant RDSPIN for this year, obviously from quarter to quarter month to month, it can bounce around a little, but I think the first quarter is pretty indicative of where we're going to end up.
Effort and activities that are underway this year with some of the preclinical efforts in cabinets.
Cabot's.
Pvp, So we ended up with a relatively constant.
<unk> spend for this year, obviously from quarter to quarter month to month that can bounce around a little bit.
I think the first quarter is pretty indicative of where we're going to end up.
And I, with regards to the work being done with Pranovo, which is a subsidiary of Princetonius, you know, with any of these markets, it's really a matter of.
With regards to the work being done with <unk>, which is a subsidiary of presenting us with any of these markets.
It's really a matter of.
identifying those patients that can, you know, have the biggest unmet need, you know, they're not satisfied by the current standard of care, and therefore can get the best improvement and outcome in theory by using the HAV versus current standard of care. And, you know, we certainly see that in trauma where, you know, if a patient doesn't have sap in the vein or there isn't time or, you know, just use of sap in the vein harvested from the patient is inappropriate.
To find those patients that can.
<unk> have the biggest unmet need they're not satisfied by the current standard of care and therefore can get the best improvement in outcome in theory by using the HIV versus.
Current standard of care.
Yeah, we certainly see that in trauma, where.
Patient doesn't have to happen to Spain, or there isn't time or.
Just use a south of Spain harvested from the patient is inappropriate.
There's a great deal of benefit for our product, and we see that translate into, we believe, into less amputations, less length of stay in the hospital due to infections and other outcomes that not only improve the life of the patient, but also have an economic benefit to whoever is covering the cost, and in the case of trauma, that's generally the case.
A great deal of benefit for our product and we see that translate into we believe into less amputation less length of stay in the hospital due to infections.
And other outcomes that not only improve the life of the patient, but also have a.
The economic benefit to whoever is covering the cost in the case of trauma that generally though.
trauma center or the hospital. In the case of ABA access for NOVO, again, it's the same thing.
Trauma center or the hospital.
In the case of AB access with Lenovo again, it's the same thing.
And there's thinking about just US market, there's close to half million patients undergoing dialysis today, one point in time.
Yeah there is.
Thinking about just the U S market, there's close to half a million patients undergoing dialysis at any one point in time.
in the course of the year, there's probably about 200,000 AB access procedures that are done each year. So the question is, what is the subset of?
During the course of the year, there's probably about 200000.
Access procedures that are done each year. So the question is what is the subset of patients.
patients that makes the most sense for us to target when we undertake our anticipated launches. You know, which are the ones that are most underserved today. And so part of that effort was, and we learned part of that in our clinical studies, but part of that is taking advantage of the great
Patients that makes the most sense for us to target.
When we undertake our anticipated launches, which are the ones that are most underserved today.
So part of that effort with the and we learned part of that in our clinical studies, but part of that is.
<unk> taken advantage of the great database.
patients on a non-name basis that's available through the Presenious Network and trying to identify those patients that have the biggest unmet needs and therefore, you know, have the best clinical and economic benefit of using the HAV. So, you know, our friend is not volume, we're not here to be, you know, providing, you
Patients on the non name basis, that's available through the <unk>.
As any of its network and trying to identify those patients that.
It had the biggest unmet needs and therefore.
You have the best clinical and economic benefit of abuse in HIV.
Our friend does not volume, we're not we're not here to be.
Are you providing.
Setting the target.
every patient at a low cost, our intent is identify those patients and have the greatest need, therefore, you know, resolving an end-night meeting and hopefully providing economics to ourselves that make more sense that based on target
Every patient at a low cost or our intent is to identify those patients who have the greatest need therefore.
We're solving unmet need and hopefully providing economics to ourselves that make more sense.
Based on targeting those high school patients.
They like to agree and I'll just jump in here a little bit. The other thing that I think is important to point out is that this is one of the many really important things that we have to do to make sure that we have the right way.
Thank you Lee agree and and I'll, just I'll just jump in here a little bit. The other thing that I think is important to point out is that.
This is one of the one of the many really.
Hi.
really important interactions between Humasite and Fresenius. We have a number of programs that are ongoing, but again, many or most companies at our stage of development really don't have access
A really important interactions between humans site and Fresenius, we have a number of programs that are ongoing but again, many or most companies at our stage of development really don't have access to this kind of very granular data around cost of care and issues with care for patients who are in.
to this kind of very granular data around costs of care and issues with care for patients who are in one of our target therapeutic areas. So our partnership with Fresenius is really something that we're leveraging, I think, very effectively to help us both be more successful.
One of our target therapeutic areas. So our partnership with Fresenius is really something that we're leveraging I think very effectively to help is supposed to be more successful.
Understood. Thank you.
Thank you. Our next question is coming from the line of Bruce Jackson with the Benchmark Company. Please proceed with your questions.
Thank you. Our next question has come from the line of Bruce Jackson with the Benchmark Company. Please proceed with your question.
Hi, good morning, and thank you for taking my questions.
Hi, good morning, and thank you for taking my questions. Just to follow up on the cabbage program, you showed some very promising animal data with good patency, resellerization. Can you tell us about the next step in that program? So more animal studies, I believe, are anticipated. What are the things that you're going to be testing, and when do you think you might kick off the next leg of the development program?
Just to follow up on the Cabbage program you showed some very promising animal data with good patency resettled organization.
Can you tell us about the next step in that program. So more animal studies I believe our anticipated what are the things that you are going to be testing and when do you think you might kick off the next leg of the of the development program.
Bruce, thanks for that. So we are continuing very active cabbage work in baboons in large non-human primates throughout 2022. This continues to be a very active program for us. Our outputs from this will be patency and function and durability and remodeling of the HAV in this non-human setting in the chest as a revascularization conduit for the heart.
Bruce Thanks for that so we are continuing very active cabbage work in baboons enlarge nonhuman primates throughout 2020 to discontinue.
This continues to be a very active program for us our outputs from this will be patency and function and durability and remodeling of the HCV in this nonhuman setting in the chest.
As of Revascularization conduit for the heart.
In general, as you're developing significant preclinical data in this way, the typical sequence of events is to submit a pre-IND package and then to get agreement with the FDA regarding the types of preclinical data that they're going to want to see and then to go out and execute on that and then to submit the IND package for clearance for a phase one study.
In general as you're developing.
Significant preclinical data in this way the typical the typical sequence of events is to submit a pre IMD package and then two and then to get agreement with the FDA regarding the types of preclinical data that theyre going to want to see them and then to go out and execute on that and then.
To submit the IND package for clearance for for a phase one study.
So, I don't want to give dates here, but I can say that we are absolutely marching along that path.
I don't want to give dates here, but but I can say that we are absolutely marching along that path.
And I continue to be very encouraged and excited about that.
And and I continue to be very encouraged and excited about this program.
Okay, Great and then speaking of updates swiftly in the BCP program.
Okay, great. And then, speaking of dates, with the MVP program, what do you think you might have your first implant, and do you have your trial material ready to go?
When do you think you might have your first implant and do you have your trial material ready to go.
Well for the BV P implant arguably we're not as far down the line with the bio vascular pancreas as we are with cabbage, because we've been in baboons with our cabbage graph just since 2021, and we haven't yet done our first baboon implants or primate implants with with the the Pvp So it's a little bit.
Well, for the BVP implant, arguably, we're not as far down the line with the biovascular pancreas as we are with cabbage, because we've been in baboons with our cabbage graft since 2021, and we haven't yet done our first baboon implants or primate implants with the BVP.
So it's a little bit early for me to project on First in Man. Again, I think the BVP concept utilizes, in some ways,
Early for me to project on first in man.
You know again, I think that the B V. P concept utilizes in some ways.
a clinically lower risk approach because our concept is that we'll perform arteriovenous grafting with the HAV exactly analogous to what we've been doing in patients for years, but then coding that HAV with islets and looking at islet function.
Clinically lower risk approach because our concept is that will will perform arteriovenous grafting with the HIV exactly analogous to what we've been doing in patients for years, but then coding that HIV with islets and looking at island function. So you know in terms of the patient risk profile for this type of product.
So, you know, in terms of the patient risk profile for this type of product, you know, you might say that it's a little lower than for cabbage, although, you know, I mean, that remains to be discussed with the FDA.
You know you might say that it is a little lower than for cabbage. Although you know I mean that remains to be discussed with the FDA.
But that's a lot of talking, but to be honest, I really can't give you dates yet. It's just too early.
But you know that's a lot of talking but to be honest I really can't give you dates yet it's just too early.
Okay Fair.
Fair enough. Thank you very much.
Thank you. Our next questions come from the line of Josh Jennings with Callan. Please proceed with your question.
Thank you. Our next question is coming from the line of Josh Jennings with Cowen. Please proceed with your questions.
Hi, This is Eric on for Josh Thanks for taking the question maybe.
Hi, this is Eric Alford-Gearch. Thanks for taking the question. Maybe starting in TOD, is there any update on the finalization of your Phase 3 trial? In this indication, what sort of discussions have you had with the FDA around the design, and just wondering any timeline that you're able to share for when this trial is going to kick off?
Maybe just starting on <unk> is there.
Any update on the Finalization of the phase III trial.
The invitation here, what sort of discussions have you had with yesterday around the design.
Just wondering any timelines as to be able to share for windows.
Okay cool.
So yes, so we are still in the process of designing that trial. I think as I mentioned on our last call, you know, we're engaging with experts in the U.S. and in Europe because we see this as a program that might have real applicability in both geographies.
So yes. So we are still in the process of designing that trial I think as I mentioned on our last call. You know, we're engaging with experts and in the U S and in Europe , because we see this is a program that that that might have real applicability and in both geographies.
We have not begun discussions with the FDA yet around the specific trial design. Again, we're trying to take a very thoughtful approach to this and really identify.
We have not begun discussions with the FDA yet around around the specific trial design again, where we're trying to take a very thoughtful approach to this and really identify the sets of patients with peripheral arterial disease, who are going to most benefit from the product where we have the greatest clinical need.
the sets of patients with peripheral arterial disease.
who are going to most benefit from the product, you know, where we have the greatest clinical need. And so that thought process is something that we're taking very seriously and we're undertaking
And so that thought process is something that we're that we're taking very seriously and we're undertaking with thought leaders actually in the U S and in Europe are so.
thought leaders actually in the U.S. and in Europe , so when we have more specifics, we'll provide
When we have more specifics we'll provide them.
Understood that makes sense.
Understood. That makes sense. And then this would be an update on Ukraine. I'm just wondering, have there been any HADs used in cases so far or have they just been shipped at this time? I just want to make sure I have that correct. And then could you also just talk a little bit more about how you plan on training surgeons over there that will be using the HADs?
Although this was an update on cone.
I'm just wondering are there been any new conclusions.
Conclusions, so far or system slipped at this time I just want to make sure I have it correct.
Could you also just talk a little bit more about how you plan on training surgeons over the near term.
Yeah.
So, as far as the training of surgeons who will be using the HAV, we have a large number of training materials that we've developed over the past several years because, as you know, the HAV has been implanted in more than 60 sites around the world by over 100 surgeons. So, we have a tremendous amount of written material but also video instruction material that we've actually translated into Ukrainian and to Russian to make it more accessible to surgeons in the Ukraine.
So as far as the training of surgeons, who will be using the HIV. We have a large number of training materials that we've developed over the past several years because as you know the HIV has been implanted in and more than 60 sites around the world by over 100 surgeons. So we have a tremendous amount of written material but.
So video instruction material.
That we've actually translated into Ukrainian and Russian to make it more accessible to surgeons in the Ukraine. In addition, we've undertaken structured training.
In addition, we've undertaken structured training with aided by surgeons in the U.S. and surgeons in Poland who have used the product.
With with aided by by Surgeons in the U S and surgeons in Poland who've used the product.
to really give sort of live virtual training to surgeons who will be implanting the HAV and then taking care of patients thereafter.
To really give sort of live virtual training to surgeons, who will be implanting. The HIV and then taking care of patients thereafter.
So, we've taken this part, you know, very seriously. I think surgical training is very important, particularly in this type of humanitarian situation. And I'm sorry, could you?
So so we've we've taken this part you know a very seriously I think surgical training is very important particularly in this type of humanitarian situation.
And I'm, sorry could you could you repeat the first part of your question again.
Sure Yeah, I was just asking.
Sure, yeah, I was just asking if any of the HAVs shipped to Ukraine have actually been used in cases, or...
And she rose six Ukraine, we've actually been used in cases, where it is.
It may be too early, I understand this is a recent update, but it was a
It may be too early I understand this is a recent update but I was just curious yes, yes, not yet the HIV is actually left are building seven days ago, and I think theres still in transit to some of the various medical centers. So it is a little too early but but we are we're obviously maintaining close contact with.
Yes, yes, not yet. The HAVs actually left our building seven days ago and I think they're still in transit.
to some of the various medical centers, so it is a little too early, but we're obviously maintaining close contact with the surgeons who will be receiving these products. And we've also instituted reporting mechanisms that are simple and easy to use for these people in this wartime situation, but we're doing our best to collect
The surgeons, who will be receiving these products and we've also instituted re.
Reporting mechanisms that are simple and easy to use for these people in this war time situation, but but we're doing our best to collect adverse events and positive clinical outcomes from any patients who received the HIV, but as yet no. One has received it.
adverse events and positive clinical outcomes from any patients who receive the HAV. But as yet, no one has received it.
Okay excellent. Thank you for the questions.
Yeah.
Thank you I'm showing no further questions in the queue. At this time. This does concludes the humans say fourth quarter and year end results conference call. Thank you all for participating.
Thank you. I'm showing no further questions in the queue at this time. This does conclude the human site fourth quarter and year end results conference call. Thank you all for participating.