Q4 2020 Precigen Inc Earnings Call
Good day, and welcome to <unk> fourth quarter and year end 'twenty 'twenty financial results Conference call.
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I would now like to turn the conference over to Steve Harrison. Please go ahead.
Thank you operator, and thank you all for joining US today with me are Doctor Hell on subs of Ari, President and CEO price agenda, and Tom Samuelson head of financial strategy.
Helen will provide an update on our pipeline and technologies after which Tom will review our fourth quarter 2020 financial results. Following prepared remarks, we will open the call to Q&A before we begin let's briefly review our forward looking statements.
During today's call, we will make various forward looking statements.
Investors are cautioned that these statements are based on current expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated by our forward looking statements.
Please read the Safe Harbor statement contained in this presentation as well as the risk factors contained in precedent in <unk>. Most recent SEC filings for a more complete discussion of these risks and uncertainties.
I will now turn the call over to a doctor's office at Ari.
Thanks, Steve and thank you to everyone, taking the time to listen in today and I Hope this call clients all of our stakeholders and their families safe and healthy it.
It is great to come out with all of you today to review our 2020 highlights on financial results.
<unk> continues to execute on wants to achieve our mission of delivering novel treatment option to patients with unmet medical needs.
I'm very proud of our team's achievement during 2020, it truly was a transformative year for us in several ways.
First and foremost.
We implemented rigorous health and safety measures to ensure research and clinical trial continuity.
As a result, we were able to meet all of our stated clinical milestones during a very challenging year.
Second the company successfully transitioned to a health focused company.
Last year, we made major strides in optimizing our operations to become more nimble and focused on.
Dancing on exciting portfolio of innovative therapeutic candidates.
Third we fortified our financial position through a capital raise on our fiscal discipline.
Tom will provide additional details on our quarterly numbers later in the call.
Finally, we made meaningful advances across our portfolio.
Completing important clinical and manufacturing milestones that position us well on exciting 2021.
Now moving to a recap of our portfolio progress from our transformative ultra car T platform.
As we started the year in 2020, our main goal for this platform was to validate overnight decentralize manufacturing and demonstrate in vivo expansion and persistence of car T cells.
Based on the day that will be presented during our update call in December.
We've demonstrated our ability to successfully manufacture our ultra car T cells across multiple sites and have shown robust expansion and persistence in vivo, even without the need for lymphoid depletion in both solid and hematological tumor settings.
Furthermore, we've demonstrated encouraging clinical activity in our lowest dose cohorts on excellent safety profile with no dose limiting on neurotoxicity is to date in either crime.
In addition, the aimed at advancing the platform towards becoming a scalable on a commercially viable therapeutic option.
Production of Ultra parade or our semi closed high throughput system is intended to be a viable scale up on commercialization solution for decentralized Ultra car T manufacturing.
Okay, operator includes hardware and software solutions and potentially represents a major advancement over our current electroporation devices by significantly reducing the process time on contamination risk.
System was cleared for clinical manufacturing used by FDA and we have started dosing patients with ultra car T cells manufacturing using ultra per meter for both our hematological and solid tumor car T trials.
Okay.
I put the tribes pier G on 3005 targeting on shed Mark 16.
One one b trial in patients with ovarian cancer.
Initial data presented in December four P. O G. On 3005 Ultra car T cells showed encouraging expansion and persistence after low dose IP infusion without lim for depletion.
In addition, 50 per cent of patients treated three out of six.
Either dose level, one or dose level, two with low doses between six and 21 million Ultra car T cells with no name for depletion experience regression in total target tumor burden.
On two out of the six patients achieved stable disease. According to resist criteria at the Restaging evaluation.
Dose expansion continues in the IP arm and we are looking forward to initiating the expansion phase in the second half of 2021 we.
We have now received clearance from the FDA to initiate dosing in the I V on off PR. Gen 3005 phase one trial concurrently with IPR and I'm happy to announce that we have successfully dosed the first patient in the IV arm.
And for Pier G. On 3006, we announced encouraging data from the ongoing phase one a smash one be clinical study in patients with relapsed or refractory acute myeloid leukemia AML on higher risk Myelodysplastic syndrome.
At the Ash annual meeting in December.
As presented at Ash by RPI, Dr. Solomon peer Gen 3006 sales showed encouraging expansion and persistence and peripheral blood after low dose infusion.
Between one and 29 million Ultra car T cells in boat the limb for deflation on non live for depletion cohort as well as the ability to traffic expand and persist in bone marrow from.
Or PR Gen 3006 treatment indicated clinical activity.
Every day by reduction in AML tumor blast level.
The potential strength of this platform was highlighted at Ash 2020 cases study of patients with multiple prior treatment failures, but ultra car T cells persisted for more than seven months. After a very low dose only at 24 million total ultra car.
T cell infusion without prior lymphoid depletion.
Patient showed a decline in blast levels in blood and bone marrow concomitant with ultra car T expansion and persistence on how to stable disease.
But our update in December a patient who received pier G. On 3006 at dose level, one with approximately 9 million south with lymphoid depletion had an objective response and achieve cri per E. L N criteria.
I am now pleased to report that this patient had subsequently received on hematopoietic stem cell transplant, and he's doing well, which according to Dr. Solomon is very encouraging outcome.
We are simultaneously enrolling in the dose escalation phase of boat the lymphoma, and non lymphoid depletion arms and are on track to initiate the expansion phase in the second half of 2021.
We look forward to our investigators providing clinical updates on these ongoing trials at upcoming medical conferences.
As we continue to provide clinical validation of the ultra car T platform B.
We believe we are underway to creating a tool for precision medicine.
Our goal is to develop and validate a library of non viral plasmids to target tumor associated antigens.
Based on the patient's cancer indication on biomarker profile.
One or more non viral plasmid would be selected from the library to build a personalised ultra car T treatment.
After initial treatment. This approach has the potential to allow for re dosing of the ultra car T targeting the same or a new tumor associated antigens based on the treatment response and the changes in antigen expression of the patients tumor.
We believe this is the only platform that has the flexibility to generate multiple autologous car Ts for patients re dosing if needed at the same time has the potential to do so at a lower cost.
This is very exciting prospects for advancement of personalized medicine.
Now, let's turn to I didn't averse immunotherapy platform, which is based on our gorilla I Didnt know vector library.
It has a high payload capacity and provides the ability to read those both advantages to competing approaches.
Okay.
Now moving to our first in class Pier G. On 2009, which is in a phase one phase two trial to treat HPV positive solid tumors under our credo with NCI.
In August we.
The first patient was dosed on in January we announced the completion of enrollment in the phase one monotherapy dose escalation arm of the trial.
All six patients enrolled in the phase one monotherapy arm have received multiple pier G. On 2009 doses and to date. The repeated administration has been well tolerated with no dose limiting toxicities.
Preliminary court relative analysis showed that hundreds per cent three out of three of patients treated at dose level. One demonstrated an increase in HPV 16, and or HPV 18, as specific T cell responses post P O G in 2009.
Iteration.
Furthermore.
The repeat administration of P. O Jan 2009 resulted in an increase in magnitude and breadth of HBV specific immune response. This highlights the potential differentiation of I didn't reverse platform compared to existing treatments.
We were very encouraged with the preliminary findings and look forward to providing further updates in the coming months.
We have initiated dosing in the combo portion of the trial, which includes PR Gen 2009, and M 70 824.
We anticipate on interim phase one readout in the second half of 2021.
And to initiate the phase two portion of the trial in the same timeframe.
Now moving on to P. O G. In 2012, which is our first I didnt averse programs targeting infectious disease.
P. R. G. On 2012 is an investigational off the shelf immunotherapy for the treatment of recurrent respiratory papillomatosis or our RP.
In January 2021.
Now that the FDA had cleared the IMD application to initiate the phase one clinical trial and we expect initial dosing first half of 2021.
Finally in January we presented preclinical data for P. R V on 2013 on it I didn't reverse therapy for hepatitis B HBV infection.
This therapy incorporate novel HBV antigen design, and our gorilla I didn't affect us.
The data showed that P. O G. In 2013 induce superior cytotoxic T cell responses against more HBV epitopes in mice than our competitor vaccine candidate and decreased plasma hepatitis b surface antigen levels.
The key marker for chronic HBV infection.
We are very encouraged by these day, though and opportunity to advance this program towards the clinic and infectious disease.
Now moving to a phase one b to a trial of a G. Zittel, one nine which is based on our actual biotics platform.
We have completed enrollment in ages that are one nine for treatment of T. One day in the phase Iia combo arm of the trial.
In December we provided positive data from the phase one b to a portion of the trial showing an encouraging trend in insulin C peptide levels and ability to induce antigen specific immune modulation. Following only one treatment oral cycle of AG 019.
<unk> as a monotherapy or combination.
We expect to provide 12 month follow up data in the adult arm in the phase two a portion during the first half of 'twenty 'twenty, one and into adolescence on in the phase Iia portion during the second half of the 2021 we are engaged.
With the regulatory agencies for the next phase trial design with the goal to rapidly advance this program towards the BLA.
Finally for Ion X and 4001, our phase one trial for heart failure.
We have completed 12 month follow up in the Phase one study with the solid safety profile and encouraging clinical activity and as we speak we are actively involved in partnering discussions.
Now I will turn the call over to Tom for an overview of our financial results Tom.
Thank you Helen and good afternoon to our stakeholders on the call.
As precedent transition to a highly focused human therapeutics company throughout the year, our primary financial objectives were to ensure that our capital will be deployed to our most promising product candidates and to solidify our balance sheet.
We committed to streamlining our costs through divesting or suspending non health operations that consumes capital transitioning our two lead commercial subsidiaries Trans Ova genetics and price of gin exemplar to be net positive contributors of capital.
And aggressively pursuing reductions of corporate and other operating expenses throughout the company.
We're happy to report strong performance across all of these initiatives.
On the 2019 to 2020, we reduced our total capital requirement as defined by our primary operating metric segment, adjusted EBITDA plus corporate expenditures from $190.3 million to $84.3 million. Please recall that this metric which is fully defined.
Our SEC filings is generally the sum of net cash operating expenses and capital expenditures.
This year over year change of $106 million or 56%.
<unk> reductions in both continued and discontinued operations are.
Discontinued operations include assets that we sold in early January of 2020, such as Oxitec and Okanagan specialty fruits and operations that we suspended during 'twenty 'twenty predominantly MBP Titan.
We use the assets required more than 80 and $17 million in 2019 in 'twenty 'twenty, respectively that we will no longer need to support.
Among our continuing operations, we required $66 $8 million in 'twenty 'twenty versus $109 8 million in 2019.
$43 million or 39% year over year reduction achieved without impairing the progress if any of our primary clinical candidates or platforms.
EBITDA at our two main revenue generating subsidiaries presage, an exemplar and trans Ova genetics improved by a combined $14 $6 million.
We committed on last year's call that neither entity would draw capital away from crashed adjourn and are pleased that both were substantial contributors of cash.
We reduced our corporate headcount by 31 per cent and corresponding capital requirements by more than $12 million or 25% euro per year.
While we anticipate that our human therapeutics capital requirements will increase to support our growing pipeline of candidates, we will maintain strict discipline and electing which candidates to advance and remain committed to continued financial efficiency across the entire organization.
We're pleased with our current balance sheet strength.
In addition to converting $56 $8 million and total debt to common equity. During 2020, we recently completed an underwritten public offering resulting in net proceeds of approximately $121.2 million.
Pro forma for the operating proceeds we began 2021 with $221 $4 million on cash.
We believe that this balance will support our anticipated capital needs into 2023.
Even allowing for focused increases in spend required to catalyze continued fast pace advancement of our therapeutic candidates I'd now like to turn the call back to Helen.
Thank you Tom.
'twenty 'twenty, one promises to be another transformative year for our company with many data Readouts on trial initiations anticipated for our key programs.
We have sufficient cash on hand to achieve these milestones this year and into 2023.
We are excited to advance our pipeline of innovative therapies and technology platforms for what as quickly as possible on our entire team remains committed to achieving this goal on behalf of the patients and share holders, which motivates us every day operator.
You May now open the line for questions.
Thank you we will now begin the question and answer session.
To ask a question you May Press Star then one on your Touchtone phone.
If you are using a speakerphone please pick up your handset before pressing the keys.
To withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble our roster.
Our first question comes from Jason Butler with JMP Securities. Please go ahead.
Hi, Thanks for taking the questions.
First one how long is there any more color you can give us on the patient with the Cri and the subsequent a transplant in the 3006 trial anything about the dynamics or timelines of the response.
Or or anything about patient characteristics or tumor cytogenetics that can inform future development or patient selection.
Thank you Jason and good.
Glad to have you on the call I'm definitely so this patient is we are really excited and it's the first patient that was treated in a NIM forward depletion arm all their P. On Gen 3006.
And I deal with the very low dose <unk> to be exact actually it was $8 7 million cells that these patients receive autologous or overnight.
Well our car Ts that are the patient received the patient was dosed and and fall in October I believe October of November and when we gave the R&D day patient was in.
What's not in it and.
Really.
Yet, let's put it this way.
Followed completely that it was considering MLS which was very close to a CR a.
But the Hematological correspondence had not been.
On the weighted on.
In January the patient of Dr. Solomon consider the patient as the Cri, which is the complete response mid day incomplete hematological recovery on basically in these patients when they use that are incomplete hematological recovery, mainly it's the first.
Two the platelet count that has not been back to the full level.
That would consider a day complete a CR without the immunological recovery and but the patient the bone marrow mm for these patients the bone marrow blast has to be below 5% and the patient achieved that is it.
Went below the five per cent there has to be no blast cells in the blood and there was no blast cells in the blood and consequently, the patient was now basically after reevaluation could receive the bone marrow transplant and this is very exciting because this is the on.
Ultimate basically resolved for the patients these patients in AML, which they had failed everything else on.
And now the patient was are eligible to receive their bone marrow transplant and actually the patient has received it and has been doing very well in the follow up. So we are really excited especially with such low dose of <unk> on ultra car T. In the first patient that we have.
Treated in the lymphoma depleted on.
That's great and so on and then just one more from me.
Just in the context of the low dose you're seeing responses already and the safety profile can you just talk about how high you might Wanna goes for how you think about where where to expand cohorts versus continuing to look at higher doses.
Yeah, so as we.
We have communicated and non lymphoid depletion arm, we are already net third dose cohort, which is a 1 million per kilo Gram and are we on obviously, finishing that and following those patients and then in and lymphoid depletion we have entered into a second co.
Horton.
Currently we are evaluating the Turks cohort and we have to follow up and then we make a decision on the AML.
Both from the data that we get from the lymphoid depletion unknown lymphoid depletion at what dose on.
And actually what treatments are we will be going for the expansion.
Okay.
Our next question comes from Ben Burnett with Stifel. Please go ahead.
First of all I've been I want to welcome you to the group. Thank you very much to being on the call on as ours.
Analysts almost stifled thank you.
Great. Thank you. Thank you for the welcome I appreciate that maybe.
Just two questions actually wanted to follow up on on the previous discussion around the Cri that you observed in the AML patient I was just wondering if you could maybe talk about some of those clinical events that you mentioned, the cri and the patient being themes.
Debt for transplant, how does that correlate with some of the cell expansion data like.
When they went on to transplant do they still have a car T in their system.
So we have been able to follow these patients for a certain period of time and there was a very good expansion of the cells on persistence in this patient up to the point that we had received the itself.
Have not unfortunately, we don't have a direct sales.
It's before debt transplant are free.
From these patients so I cannot answer that question, but.
But during the time the expansion and dealing debt, Italy months that we are.
Actually we have received up to I believe at least two months.
And after the infusion and we saw expansion very good expansion on persistence of T cells and are obviously also in the bone marrow because the patient caring majority of the blast cells in the bone marrow and one of the criteria for and complete response is that the bone marrow.
<unk> has to go well below five per cent and that's exactly what happened.
Okay, that's great color I appreciate that.
Hmm, maybe one other one just on the ovarian cancer program. So for this next update I guess, what are you expecting to see in terms of cell expansion data as you as you dose escalate and I guess does this read out a good proxy for what's happening in the primary tumor.
Or do you think it maybe is a better proxy poor cardiac caveat I'd like just to metastatic sites yeah.
Excellent question, but actually because in this first arm, we are infusing I P and not IV. Therefore, when we are reading we are reading debt actually the number of the car Ts in the blood. So it's I don't think the kinetics of the expansion net.
Certainly, it's being presented as well in the blood because we are infusing the cells are <unk>.
Perez tonelli, but what we have seen up to date and we showed in December or some of debt patients on that is definitely the direct effect on debt.
Tumor lesions, which is quite impressive for these patients that they had upwards of seven failure of the treatments prior quite sick on upward, though some of them 10 lesions or more in various areas and what we saw was in 50 per cent of the pace.
<unk> three out of the six we had 50 per cent reduction in debt total tumor burden on number of Crs and Prs in distant like bladder for instance, lesion. So I think that will be the major readouts, but it's still we have been able to show in the blood that day.
Or is the expansion and persistence places and one of the patients we could follow up to three months and we could see yourself what is exciting I read Justice started on I think we communicated. This in this call was that FTA now based on the safety has allowed us to.
Common sense, let's start the IV, if you'll recall FDA had asked US what are you generally to finish the IP arm completely before we start the IV arm and now we will have received the permission to start the IV and V. We're really excited we have dosed our first.
V patient and are we will be following on I think we will get more color to the kinetics of the expansion and persistence in that way as well.
Super interesting okay. Thank you very much sure.
Okay.
Our next question comes from Nick Abbott with Wells Fargo Securities. Please go ahead.
Hello.
I would like to tell from your thoughts at all Thank you, yes, that's actually Chuck Whitesell in from Nick Abbott and thank you for the welcome and Nick I. Appreciate says well I had two questions. One is for your universe platform, specifically PRT on Tuesday zero nine could you elaborate on how your day.
Differentiated from other HPV cancer vaccines, absolutely so.
First of all our platform that I Didnt averse platform is.
It's differentiated in the sense that this gorilla vectors.
Because there is a no seropositive as youre very little suite of positivity in the humans you can give them number of time, unlike at fives or the other of our retroviruses or in general here, you can keep injecting and pre clinically before.
We had shown that you can expand the T cells in preclinical models.
So using our platform for P. O G. On 2009 that are of the gorilla that he's the first differentiation factor than anything guidance out there.
And part of this is really the antigens that we target debt in HBV and generally there are.
Second antigens that are its target debt and majority on all of the companies. They use the same but we have done over the years and last year. It was really expand the breadth of the epitopes.
That's on in our Pier G N 2009, and what we have shown with that is that.
Basically we incorporated a new parts of the virus basically profiles that no one else really has identified before through our bioinformatics and incorporated in that and we were really excited for the first time.
When in J P. Morgan, we showed that the preliminary data from N C. I know the base not only the safety and excellent safety that we have shown with the PR Jan 2019 in mono therapy, but also the fact that you can now repeat dose these on.
Exactly as we had predicted you keep increasing the number of the T cell and I think that is what it made a lot of difference on.
The differentiation factor to what we have for power Gen 2009 versus all the other competitors.
Great Wonderful and my second question is could you elaborate on your general strategy from partnering certain assets.
Absolutely so on the philosophy in regards to the partnering is.
Actually we especially on the Mi coming from a big pharma Yeah, you have to be aware that there has to be at a certain level of maturity in general to be able to be presented on also always data is what is it speaks for the asset, especially.
When you get to the clinical level. So for the past two years, what we have done was first of all built a diverse portfolio and maximize our platform for bringing in the targets that we believe it has the high ability for success for the patients.
And then built a very solid preclinical and eventually clinical data around it and that's what we have done and.
Over the period of time in regard to some of these assets. We know that for instance, we have to focus on certain assets that we have index then they called ready some of the targets that we have we look to a partner perhaps in a preclinical stage.
In some other targets like for our 4001, which has been focused on debt.
Cardiac field and currently our focus is all in oncology and autoimmunity and infectious diseases and this asset after finishing the phase one for 4001 with a very good safety and very encouraging data for from the phase one, which we will be reported.
On D C S.
We saw fit that it's best for partnership and that's what we have inter and as I mentioned, we are in discussions for partnership for instance that I said, so I think we are continuously evaluating our portfolio and look at the various opportunity on the maturity of the data sets and with <unk>.
In mind and also their partnerships that they come up we would evaluate.
On the strategically makes a decision has been.
Our next question comes from Eric Joseph with Jpmorgan. Please go ahead hi.
Oh Hi, good afternoon. This is Hannah on for Eric Thanks for taking on a question that's just from from Us from.
As for 3000, I'm sick, given the safety data you've seen to date.
I'm just wondering if you would consider any changes to the lymph node depletion regimen, that's being used.
And your uninterested in pursuing a more rigorous regimen.
Well actually.
We don't need to pursue more rigorous regiment of lymphoid depletion to be honest with you because even in our non NIM for depletion arm, we have seen a very exciting.
On a preliminary data we reported on a patient that basically came out of the hospital.
To receive that somewhat or on the 20th Melia himself.
On this patient went on to not only expand these cells on persistent sales for over seven months and the last basically samples that we had but also the patient showed that in conjunction with expansion and persistence of the ultra com.
Directly in the patient the blast cells, both in the peripheral blood and bone marrow decreased and that was also in conjunction with the biomarker.
Kris of per frame, which is directly.
It's attached to dissect the toxicity of the ultra car T cells against tumors. So right now I think we have the regular lymphoid depletion regimen, which is not an aggressive one and we have an arm without them for depletion and I think.
We will finish this dose expansion and then we would evaluate that a newbie need lymphoid depletion can we do without them for depletion and I think based on debt. We will go to expansion. So I don't see any reason for a more aggressive lymphoid depletion.
Okay.
Again, if you'd like to ask a question. Please press Star then one our next question comes from Arthur He with each C. Wainright. Please go ahead.
King.
Hey, good afternoon, Thanks for taking my question.
I had two question of first regarding the three O six could.
Could you give us an update on on the follow up data for the patient in a case study you present at Ash last year.
And the.
Second question is.
Considering you guys wanted to secure a decent cash wrong way.
Could you give us enough data the OEM business strategies regarding the trends overall and exemplar. Thank you.
I think on the patients are in the Ash and I believe this I have to refer back to Dr. Solomon as they follow ups. So just I want to make sure I don't give any kind of information.
That is a wrong saw their updates on that patient day patient.
Well I can just tell you.
<unk> long as we had followed on gotten reports into R&D, which we reported at that time, So I will.
Definitely look into debt and get back to you free in regard to that update as far as our financial strategy. I think we have Tom can speak to that as we have mentioned we have a good runway now to 2023.
And Tom if you went out yeah, I think one on one of the things that we are that we talked about at the beginning of the year was putting all of our operating revenue generating subsidiaries.
On our position.
Where the businesses are are flourishing and also contributing cash.
And we're really excited with the progress we've made on both of them.
Both of the businesses have.
Uh huh.
Our mind I've been performing very well and we'll continue to do so I wouldn't say, we have any particular updates.
On the strategic side for both businesses beyond what I've shared that.
Okay. Thank you. Thank you very much.
Our next question comes from Justin Walsh with B Riley Securities. Please go ahead.
Welcome Justin as well.
Hi, Thank you for taking my question and congrats on the progress. So my first question is related to the <unk> two years ago nine.
Have you put any thought into what signals you need to see to pursue various indications for the asset I know the NCI trial is moving into the phase II portion with the HPV positive oral pharyngeal and Sino nasal squamous cell cancer, but what about the other HPV driven cancers and obvious.
Cervical cancer is at the top of the list there.
So on question actually we are really excited about our PR Gen 2009, and Adam are worse, because as you know.
The first six patients in this trial.
All Commerce every day HPV positive.
So among them a we also had a number of patients that had a cervical cancers.
And and debt design of Pier G. In 2009, and the epitopes that covers actually lends itself to not just only head and neck, but all day.
And currently we are looking at the expansion and are entering to the cervical cancer because that's the one area that's very very exciting.
And also one of the things that I would like to mention in regard to on Pier G. In 2009 as I had mentioned before these are platform allows us really to generate and there are specific T cells with TCR directly in patients and with the ability.
To keep giving this vaccine.
<unk> seen over and over again and by the way. This is not like the vaccines that are by debt when I was heading the vaccines.
We're being generated that the platforms have advanced on especially this I don't know wireless platform is very very unique in its capability for the coverage of the payload that it has but also for these repeated dosing that keep expanding your T cell the specifics.
Over on over again.
And this allows.
Sort of expanded coverage of your debt epitopes.
We are moving towards not only they had on NEC in phase two but also in cervical cancers are in the upcoming year and we will be addressing this.
Definitely in second half of this year as NCI will be reporting on the results of our phase one.
And I would say stay tuned it's going to be very exciting.
Thank you that's very helpful and last question from me. So your vision of having a patient having tumor associated antigen selected and used for treatment immediately with multiple potential rounds of ultra car T is really compelling can you provide some color on how we might get from concept to reality for some.
Like that would each combination of antigen expression on the car needs to go through regulatory review or regulators think of it more like a neo antigen approach.
I think this is exactly what you mentioned is correct.
We are in discussions on free will be further discussing our debt trial setup.
And it's FDA that to your point it would be more like a neo antigen, but with the difference here that you don't need to produce neo antigens identified the neo antigen and then built and TCR.
Four weeks upon weeks on the multiple TCR that you might need.
By having get ultra vectors to volume antigens that on by the way share among different indication price then.
If you look at the library of the antigens that we have you can have Mark 16, you can have mesothelioma and you can have mark one any of these can be share for number of indications across in lung pancreatic ovarian and bladder.
Answer and you can see that you basically with overnight you can produce any of these or combinations of these and the important part is we have already gone.
And through their manufacturing and have shown that we can do this overnight and to see the next day on infusion to their patients. We are as we speak finishing odd dosing. So we are establishing day safety in the clinic as well as the doses and I think we did days.
We have generated both from debt solid tumor side of ovarian cancer indication and the Hematological one on the AML. This is what we are using in our discussions for the F. D. A and then having what I consider and umbrella trial that basis.
On the you can have different indications coming in and then having tested or re dose or a mixture of the cells being infused to the patient depending on the molecular profile of the tumor that they have so your point about.
Neil antigen are correct.
But with the difference that we don't have any of the obstacles that the TCR neo antigens tough.
Because we are using the library of antigens that are easily accessible to our ultra vector our manufacturing is overnight on became manufacturer as many as it's needed at the doses that are needed and we can repeat dose.
This concludes our question and answer session I would like to turn the conference back over to Helen Xu Barry for any closing remarks.
Thank you very much first of all I want to thank everyone for taking time to listen to our call and for the taught full questions.
We look forward to providing updates at the upcoming investor and scientific conferences on to meet with you in the coming months. We are very excited about our programs and we look forward to on next basically interactions.
With all the analysts then on investors. Thank you.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.