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spk03: Good day and welcome to Precision Fourth Quarter and Year-End 2020 Financial Results Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your touchtone phone. If you would like to withdraw your question, please press star, then two. Please note this event is being recorded. I would now like to turn the conference over to Steve Harrison. Please go ahead.
spk00: Thank you, Operator, and thank you all for joining us today. With me are Dr. Helen Sabzavary, President and CEO of Precision, 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 the 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 State Farber statement contained in this presentation, as well as the risk factors contained in Presagen's most recent SEC filings, for a more complete discussion of these risks and uncertainties. I will now turn the call over to Dr. Zabzavary.
spk02: Thanks, Steve, and thank you to everyone taking the time to listen in today. I hope this call finds all of our stakeholders and their families safe and healthy. It is great to connect with all of you today to review our 2020 highlights and financial results. Precision continues to execute and work to achieve our mission of delivering novel treatment options 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. Throughout the year, we made major strides in optimizing our operations, to become more nimble and focused, advancing our exciting portfolio of innovative therapeutic candidates. Third, we fortified our financial position through a capital raise and a 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 for an exciting 2021. Now, moving to a recap of our portfolio progress. The first, our transformative UltraCar T platform. As we started the year in 2020, our main goal for this platform was to validate overnight decentralized manufacturing and demonstrate in vivo expansion and persistence of CAR T cells. Based on the data we presented during our update call in December, we 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 lymphodepletion in both the solid and hematological tumor settings. Furthermore, we demonstrated encouraging clinical activity in our lowest dose cohorts and excellent safety profile with no dose limiting or neurotoxicities to date in either trial. In addition, We aimed at advancing the platform towards becoming a scalable and commercially viable therapeutic option. The introduction of Ultraoperator, our semi-closed, high-throughput system, is intended to be a viable scale-up and commercialization solution for decentralized ultra-car team manufacturing. Ultraoperator includes hardware and software solutions and potentially represents a major advancement over current electroporation devices by significantly reducing the process time and contamination risk. This system was cleared for clinical manufacturing use by FDA, and we have started dosing patients with ultracar T cells manufacturing using ultraproider for both our hematological and solid tumor CAR T trials. As for the trials, PRGN-3005 targeting unshed MUX16, a phase 1, 1B trial in patients with ovarian cancer. Initial data presented in December for PRGN-3005 ultracar T cells showed encouraging expansion and persistence after low-dose IP infusion without lymphodepletion. In addition, 50% of patients treated, three out of six, at either dose level one or dose level two with low doses between six and 21 million ultracar T cells with no lymphodepletion experienced regression in total target tumor burden. And two out of these six patients achieved a stable disease according to research criteria at their 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 have now received clearance from the FDA to initiate dosing in IV arm of PRGN 3005 phase one trial concurrently with IP arm. And I'm happy to announce that we have successfully dosed the first patient in the IV arm. And for PRGN 3006, we announced encouraging data from the ongoing Phase 1-1B clinical study in patients with relapsed or refractory acute myeloid leukemia, AML, and higher risk myelodysplastic syndrome at the ASH annual meeting in December. As presented at ASH by our PI, Dr. Solomon, PRGN3006 cells showed encouraging expansion and persistence in peripheral blood after low-dose infusion. Between 1 and 29 million ultracar T cells in both the lymphodepletion and non-lymphodepletion cohort, as well as the ability to traffic, expand, and persist in bone marrow. Furthermore, PRGM-3006 treatment indicated clinical activity as evidenced by reduction in AML tumor blast levels. The potential strength of this platform was highlighted at ASH 2020 case study of patients with multiple prior treatment failures where ultracar T cells persisted for more than seven months after a very low dose only a 24 million total ultracar T cell infusion without prior lymphodepletion. This patient showed a decline in blast levels in blood and bone marrow concomitant with ultracar T expansion and persistent and had a stable disease. For our update in December, a patient who received PRGN 3006 at dose level 1 with approximately 9 million cells with lymphodepletion, had an objective response and achieved CRI per ELN criteria. I am now pleased to report that this patient has subsequently received a hematopoietic stem cell transplant and is doing well, which according to Dr. Solomon is very encouraging outcomes. We are simultaneously enrolling in the dose escalation phase of both the lympho and non-lympho 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 Ultracar-T platform, we believe we are on the way 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 and biomarker profile, one or more non-viral plasmids would be selected from the library to build a personalized ultracar T treatment. After initial treatment, this approach has the potential to allow for redosing of the ultracar T targeting the same or a new tumor-associated antigen based on the treatment response and the changes in antigen expression of the patient's tumors. We believe this is the only platform that has the flexibility to generate multiple autologous ultracar T's for patients. Redosing, if needed, at the same time has the potential to do so at the lower cost. This is a very exciting prospect for advancement of personalized medicine. Now, let's start to adenoverse immunotherapy platform, which is based on our gorilla adenovector library. It has a high payload capacity and provides the ability to redose both advantages to competing approaches. Now moving to our first-in-class PRGN 2009, which is in a phase one, phase two trial, to treat HPV-positive solid tumors under a cradle with the NCI. In August, we announced the first patient was dosed, and in January, we announced the completion of enrollment in a phase one monotherapy dose escalation arm of the trial. All six patients enrolled in the phase one monotherapy arm have received multiple PRGN2009 doses, and to date, the repeated administration has been well-tolerated with no dose-limiting toxicities. Preliminary correlative analysis showed that 100%, three out of three of patients treated at dose level one demonstrated an increase in HPV16 and or HPV18-specific T cell responses post-PRGN 2009 administration. Furthermore, repeat administration of PRGN 2009 resulted in an increase in magnitude and breadth of HPV-specific immune response. This highlights the potential differentiation of adenovirus 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 a combo portion of the trial, which includes PRGN 2009 and M7824. We anticipate an 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 PRGN 2012, which is our first adenovirus program targeting infectious disease. PRGN 2012 is an investigational off-the-shelf immunotherapy for the treatment of recurrent respiratory papillomatosis, or RRP. In January 2021, We announced that the FDA had cleared the IMD application to initiate the Phase I clinical trial, and we expect initial dosing first half of 2021. Finally, in January, we presented preclinical data for PRGN 2013, our adenovirus therapy for hepatitis B HBV infection. This therapy incorporates novel HPV antigen design in a gorilla adenovactor. The data showed that PRGM 2013 induced superior cytotoxic T cell responses against more HPV epitopes in mice than a competitor vaccine candidate and decreased plasma hepatitis B surface antigen levels, the key marker for chronic HPV infection. We are very encouraged by this data and the opportunity to advance this program toward the clinic in infectious disease. Now moving to a Phase 1b-2a trial of AG019, which is based on our Actobiotics platform. We have completed enrollment in AG019 for treatment of T1D in the phase 2A combo arm of the trial. In December, we provided positive data from the phase 1B-2A 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 AG019 as a monotherapy or combination. We expect to provide 12-month follow-up data in the adult arm in the Phase IIa portion during the first half of 2021 and in the adolescent arm in the Phase IIa portion during the second half of 2021. We are engaged with the regulatory agencies for the next phase trial design with the goal to rapidly advance this program toward the BLA. Finally, for INXN-4001, our phase one trial for heart failure. We have completed 12-month follow-up in the phase one study with a 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?
spk06: Thank you, Helen, and good afternoon to our stakeholders on the call. As Precision transitioned to a highly focused human therapeutics company throughout the year, our primary financial objectives were to ensure that our capital 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 consumed capital, transitioning our two lead commercial subsidiaries, Transova Genetics and Presagen 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 these initiatives. From 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 to $84.3 million. Please recall that this metric, which is fully defined in 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%, reflects reductions in both continued and discontinued operations. Our 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 2020, predominantly MVP Titan. These assets required more than $80 and $17 million in 2019 and 2020, respectively, that we will no longer need to support. Among our continuing operations, we required $66.8 million in 2020 versus $109.8 million in 2019, a $43 million or 39% year-over-year reduction achieved without impairing the progress of any of our primary clinical candidates or platforms. Segment and EBITDOT are two main revenue-generating subsidiaries, Presagen Exemplar and Transova Genetics, improved by a combined $14.6 million. We committed on last year's call that neither entity would draw capital away from Presagen and are pleased that both were substantial contributors of cash. We reduced our corporate headcount by 31% and corresponding capital requirements by more than $12 million or 25% year over year. While we anticipate that our human therapeutics capital requirements will increase to support our growing pipeline of candidates, we will maintain strict discipline in 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 in 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 offering proceeds, we began 2021 with $221.4 million in 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-paced advancement of our therapeutic candidates. I'd now like to turn the call back to Helen.
spk02: Thank you, Tom. 2021 promises to be another transformative year for our company. with many data readouts and 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 forward as quickly as possible, and our entire team remains committed to achieving this goal on behalf of the patients and shareholders which motivate us every day. Operator, you may now open the line for questions.
spk03: 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.
spk07: Hi. Thanks for taking the questions. First one, Helen, is there any more color you can give us on the patient with the CRI and the subsequent transplant in the 3006 trial? Anything about the dynamics or timelines or the response or anything about patient characteristics or tumor cytogenetics that could inform future development or patient selection?
spk02: Oh, absolutely. Thank you, Jason, and glad to have you on the call. Definitely. So this patient is really excited. It's the first patient. That was treated in a lymphodepletion arm of the PRGN-3006, and with a very low dose. To be exact, actually, it was 8.7 million cells that this patient received, autologous overnight, well, CAR-Ts that the patient received. The patient was dosed in fall, in October, I believe October of November. And when we gave the R&D, the patient was in, was not in a really yet, let's put it this way, followed completely that it was considered MLS, which was very close to SCR. But the hematological correspondence had not been evaluated. And in January, the patient, Dr. Solomon, considered the patient as the CRI, which is the complete response with the incomplete hematological recovery. And basically, in these patients, when they use that CRI, incomplete hematological recovery. Mainly, it's referred to the platelet count that has not been back to the full level that would consider this complete CR without the immunological recovery. But the patient, the bone marrow for these patients the bone marrow blast had to be below 5%, and the patient achieved that. It went below the 5%. There had 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 re-evaluation, could receive the bone marrow transplant. And this is very exciting because this is the ultimate, basically, a result for the patients, these patients in AML, which they had failed everything else. And now the patient was eligible to receive the 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 a low dose of our ultracar T in the first patient that we have treated in a lymphodepleted arm.
spk07: That's great. Thanks, Alan. And then just one more for me. In the context of the low dose, you're seeing responses already and the safety profile. Can you just talk about how high you may want to dose or how you think about where to expand cohorts versus continuing to look at higher doses?
spk02: Yeah. So as we have communicated in a non-lympho depletion arm, we are already in a third dose cohort, which is one million per kilogram, and we are obviously finishing that and following those patients. And then in lymphodepletion, we have entered to a second cohort. Currently, we are evaluating the third cohort, and we have to follow up, and then we make a decision on the AML, both from the data that we get from lymphodepletion and non-lymphodepletion at what dose, and actually what treatments we will be going for the expansion.
spk03: Our next question comes from Ben Burnett with Stifel. Please go ahead.
spk02: Well, first of all, Ben, I want to welcome you to the group. Thank you very much for being on the call and as our analyst from Stifel. Thank you.
spk08: Well, great. Thank you. Thank you for the welcome. I appreciate that. Just two questions. I actually wanted to follow up 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 deemed fit for transplant. How did that correlate with some of the cell expansion data? Like when they went into transplant, did they still have CAR T in their system?
spk02: So we have been able to follow this patient for a certain period of time, and there was a very good expansion of the cells and persistence in this patient up to the point that we had received the cells. We have not, unfortunately, we don't have direct cells before the transplant from this patient, so I cannot answer that question. But during the time, the expansion, and during the early months that we actually have received up to, I believe, at least two months after the infusion, and we saw expansion, very good expansion and persistence of these cells, and obviously also in the bone marrow because The patient carried majority of the blast cells in the bone marrow, and one of the criteria for a complete response is that the bone marrow blast has to go well below 5%, and that's exactly what happened.
spk08: Okay. That's great, Kala. I appreciate that. Maybe one other one, just on the ovarian cancer program. Sure. For this next update, I guess, what are you expecting to see in terms of cell expansion data 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 for cardiac cavity at distant metastatic sites?
spk02: Yeah. Excellent question, Ben. Actually, because in this first arm, we are infusing IP and not IV, therefore, When we are reading, we are reading actually the number of the CAR-Ts in the blood. So I don't think the kinetic of the expansion necessarily is being presented as well in the blood because we are infusing the cells intraperitoneally. What we have seen up to date, and we showed in December some of the patients on that, is definitely the direct effect. on the tumor lesions, which is quite impressive for these patients that they had upwards of seven failure of the treatments prior, quite sick, and upwards of some of them 10 lesions or more in various areas. And what we saw was in 50% of the patients, three out of the six, we had 50% reduction in the total tumor burden, number of CRs and PRs, in distance, like bladder, for instance, lesions. So I think that will be the major readout. But still, we have been able to show in the blood that there is expansion and persistence. For instance, in one of the patients, we could follow up to three months, and we could see the cells. What is exciting, and we just started, and I think we communicated this in this call, was that FDA now, based on the safety, has allowed us to concomitantly start the IV. If you recall, FDA had asked us originally to finish the IP arm completely before we start the IV arm. And now we have received the permission to start the IV, and we were really excited. We have dosed our first IV patient, and we will be following. And I think we will get more color to the kinetics of the expansion and persistence in that way as well.
spk08: Super interesting. Okay, thank you very much.
spk02: Sure.
spk03: Our next question comes from Nick Abbott with Wells Fargo Securities. Please go ahead. I would like to welcome you.
spk01: Thank you. Yes, it's actually Chuck Whitesalon from Nick Abbott. Thank you for the welcome, and Nick appreciates that as well. I had two questions. One is for your adenoverse platform, specifically PRGN2009, could you elaborate on how you're differentiated from other HPV cancer vaccines?
spk02: Absolutely. So first of all, our platform, the Adenoverse platform, is differentiated in a sense that these gorilla vectors, because there is no seropositivity or very little seropositivity in humans, you can give them a number of times. Unlike at-fives or other retroviruses in general, Here, you can keep injecting, and preclinically, before we had shown that you can expand the T cells in preclinical models. So using our platform for PRGN 2009, that of the gorilla, that is the first differentiation factor than anything that is out there. The second part of this is really the antigens that we targeted in HPV. Generally, there are certain antigens that is targeted, and majority or all of the companies, they use the same. What we have done over the years, last year, was really expand the breadth of the epitopes that are in our PRGN 2009, and what we have shown with that is that Basically, we incorporated new parts of the virus, basically, profile 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 NCI, not the basic, not only the safety, excellent safety that we have shown with the PRGN 2009 in monotherapy, but also the fact that you can now repeat doses, and exactly as we had predicted, you keep increasing the number of the T cell. And I think that is what has made a lot of difference and differentiation factor to what we have for PRGM 2009 versus all the other competitors.
spk01: Great. Wonderful. And my second question is, could you elaborate on your general strategy for partnering certain assets?
spk02: Absolutely. So our philosophy in regard to the partnering is actually we, especially me coming from Big Pharma, you have to be aware that the assets have to be at a certain level of maturity in general to be able to be presented. And also, always data is what 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 build a very solid preclinical and eventually clinical data around this. And that's what we have done 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 in the clinic already. Some of the targets that we have, we look to partner perhaps in a preclinical stage. In some other targets, like for our 4001, which has been focused on the cardiac field, and currently our focus is all in oncology and autoimmunity infectious diseases, This asset, after finishing the phase one for 4,001 with a very good safety and very encouraging data from the phase one, which we will be reporting this year, we saw that it's best for partnership. And that's what we have entered. And as I mentioned, we are in discussion for partnership, for instance, for that asset. So I think we are continuously evaluating our portfolio and look at the various opportunities. and the maturity of the data sets. And with that in mind, and also the partnerships that they come up, we would evaluate and strategically make a decision as we move.
spk03: Our next question comes from Eric Joseph with JP Morgan. Please go ahead. Hi, Eric.
spk09: Hi, good afternoon. This is Hannah on for Eric. Thanks for taking our question. Just a few from us. First for 3006, given the safety data you've seen to date, I'm just wondering if you would consider any changes to the lymphodepletion regimen that's being used. Is there any interest in possibly pursuing a more rigorous regimen?
spk02: Well, actually, we don't need to pursue a more rigorous regimen of lymphodepletion, to be honest with you, because Even in our non-lympho-depletion arm, we have seen very exciting preliminary data. We reported on a patient that basically came out of the hospice to receive somewhere around 20 million cells. And this patient went on to not only expand these cells and persist the cells for over seven months, in the last, basically, samples that we had. But also, the patient showed that in conjunction with expansion and persistence of the ultracard directly in the patient, the blood cells both in the peripheral blood and bone marrow decreased. And that was also in conjunction with the biomarker increase of perforin, which is directly attached to the cytotoxicity of the ultracard T cells against tumors. So right now, I think we have the regular lymphodepletion regimen, which is not an aggressive one, and we have an arm without the lymphodepletion. And I think we will finish this dose expansion, and then we would evaluate that do we need lymphodepletion? Can we do without lymphodepletion? And I think based on that, we will go to expansion. So I don't see any reason for a more aggressive lymphodepletion.
spk03: Again, if you'd like to ask a question, please press star, then 1. Our next question comes from Arthur He with HC Wainwright. Please go ahead.
spk02: Hi, Arthur.
spk04: Hi everyone, good afternoon. Thanks for taking my question. I had two questions. First, regarding the 3006, could you give us an update on the follow-up data for the patient in the case study you presented at the ASH last year? And the second question is, considering you guys already secured a decent cash wrong way, Could you give us an update on your business strategies regarding TransOval and Exemplar? Thank you.
spk02: I think on the patients in the ASH, I believe, this I have to refer back to Dr. Solomon as a follow-up. So just I want to make sure that I don't give any kind of information that is wrong. So the updates on that patients. The patient, I can just tell you as long as we had followed and gotten reports in our R&D, which we reported at that time. So I will definitely look into that and get back to you in regard to that update. As far as our financial strategy, I think Tom can speak to that. As we have mentioned, we have a good runway now to 2023. And Tom, if you want to add.
spk06: Yeah, I think one of the things that we talked about at the beginning of the year was putting all of our operating revenue generating subsidiaries in a position where the businesses 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, in our mind, have been performing very well and will 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, though.
spk04: Okay. Thank you. Thank you very much.
spk03: Our next question comes from Justin Walsh with C. Reilly Securities. Please go ahead.
spk02: Welcome, Justin, as well. Hi.
spk05: Thank you for taking the question and congrats on the progress. So my first question is related to the PRGN2009. 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 to the Phase II portion with the HPV-positive oropharyngeal and sinonasal squamous cell cancer, but what about the other HPV-driven cancers and, obviously, cervical cancers at the top of the list there?
spk02: Excellent question. Actually, we are really excited about our PRGN 2009 adenoverse because, as you know, the first six patients in this trial were all comers with HPV positive. So among them, we also had a number of patients that had cervical cancers. And in the design of PRG in 2009 and the epitopes that covers, actually it lends itself to not just only head and neck, but all these And currently, we are looking at the expansion and entering to the cervical cancer, because that's one area that's very, very exciting. And also, one of the things that I would like to mention in regard to our PRGN 2009, as I had mentioned it before, this platform allows us really to generate the information specific T-cells with TCRs directly in patients and with the ability to keep giving this vaccine over and over again. And by the way, this is not like the vaccines that when I was heading the vaccines were being generated. The platforms have advanced, and especially this adenovirus platform is very, very unique. and its capability for the coverage of the payload that it has, but also for these repeated dosing that keep expanding your T cell specifics over and over again. And this allows a sort of expanded coverage of the epitopes. So we are moving toward not only the head and neck in phase two, but also in cervical cancers in the upcoming year. And we will be addressing this definitely in second half of this year as NCI will be reporting on the result of phase one. And I would say stay tuned. It's going to be very exciting.
spk05: Thank you. That's very helpful. And last question for me. So your vision of having a patient having tumor-associated antigen selected and used for treatment immediately with multiple potential rounds of ultracar T is really compelling. Can you provide some color on how we might get from concept to reality for something like that? Would each combination of antigen expression on a car need to go through regulatory review, or might regulators think of it more like a neoantigen approach? Sure.
spk02: I think this is exactly what you mentioned is correct. We are in discussions and we will be further discussing the trial setup with FDA that, to your point, it will be more like a neoantigen, but with the difference here that you don't need to produce neoantigen, right? Identify the neoantigen and then build TCR for weeks upon weeks and multiple TCRs that you might need by having ultra-vectors to various antigens that are, by the way, shared among different indications, for instance. If you look at the library of the antigens that we have, you can have MUX16, you can have mesothelioma, and you can have MUC1, any of these can be shared for number of indication across in lung, pancreatic, ovarian, bladder cancer. 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 through the manufacturing and have shown that we can do this overnight and QC the next day and infuse to the patient. We are, as we speak, finishing our dosing. So we are establishing the safety in the clinic as well as the doses. And I think with the data that we have generated both from the 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 FDA. And then having what I consider an umbrella trial that basically you can have different indications coming in and then having tested or redosed or a mixture of these cells being infused to the patient depending on the molecular profile of the tumor that they have. So your point about neoantigens are correct, but with the difference that we don't have any of the obstacles that the TCR neoantigens have because we are using the library of antigens that are easily accessible through our ultravector. Our manufacturing is overnight, and we can manufacture as many as It's needed at the doses that are needed, and we can repeat those.
spk03: This concludes our question and answer session. I would like to turn the conference back over to Helen Sabzavari for any closing remarks.
spk02: Thank you very much. First of all, I want to thank everyone for taking time to listen to our call and for the thoughtful questions. We look forward to providing updates at the upcoming investor and scientific conferences and to meet with you in the coming months. We are very excited about our programs and we look forward to our next, basically, interactions with our analysts and our investors. Thank you.
spk03: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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