Precigen, Inc. (PGEN) Q4 2020 Earnings Call Transcript

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Precigen, Inc. (PGEN 1.43%)
Q4 2020 Earnings Call
Mar 1, 2021, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day and welcome to Precigen Fourth Quarter and Year-End 2020 Financial Results Conference Call. All participants will be in listen-only mode. [Operator Instructions] I would now like to turn the conference over to Steve Harasym. Please go ahead.

Steven Harasym -- Head of Investor Relations

Thank you, operator and thank you all for joining us today. With me are Dr. Helen Sabzevari, President and CEO of Precigen 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 safe harbor statement contained in this presentation as well as the risk factors contained in Precigen's most recent SEC filings for a more complete discussion of these risks and uncertainties. I will now turn the call over to Dr. Sabzevari.

Helen Sabzevari -- President and Chief Executive Officer

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. Precigen 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 achievements 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 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 UltraCAR-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, an excellent safety profile with no dose-limiting or neurotoxicities to date in either trial. In addition, we aimed at advancing the platform toward becoming a scalable and commercially viable therapeutic option. The introduction of UltraPorator, our semi-closed, high-throughput system is intended to be a viable scale up and commercialization solution for decentralized UltraCAR-T manufacturing. UltraPorator 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 UltraPorator for both our hematological and solid tumor CAR-T trial.

As for the trial PRGN-3005 targeting unshed MUC16, 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 6 million 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 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 have now received clearance from the FDA to initiate dosing in IV arm of PRGN-3005 Phase 1 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) a higher-risk myelodysplastic syndrome at the ASH annual meeting in December.

As presented at ASH by our PI Dr. Solomon, PRGN-3006 cells showed encouraging expansion and persistence in peripheral blood after low-dose infusion between 1 million and 29 million million UltraCAR-T cells in both the lymphodepletion and no-lymphodepletion cohort as well as the ability to traffic, expand, and persist in bone marrow. Furthermore, PRGN-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 at 24 million total UltraCAR-T cell infusion without prior lymphodepletion.

These patients showed a decline in blast levels in blood and bone marrow concomitant with UltraCAR-T expansion and persistence and had a stable disease. At 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 an hematopoietic stem cell transplant and is doing well, which according to Dr. Solomon is a very encouraging outcome. 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 this ongoing trial 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 a 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 antigens based on the treatment response and the changes in antigen expression of the patient's tumor. We believe this is the only platform that has the flexibility to generate multiple autologous UltraCAR-Ts for patients, redosing if needed, at the same time, has the potential to do so at a 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 1/Phase 2 trial to treat HPV-positive solid tumors under a CRADA with the NCI. In August, we announced the first patient was dosed and in January, we announced the completion of enrollment in a Phase 1 monotherapy dose escalation arm of the trial. All six patients enrolled in the Phase 1 monotherapy arm have received multiple PRGN-2009 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 1 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 AdenoVerse 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 1 readout in the second half of 2021 and to initiate the Phase 2 portion of the trial in the same time frame.

Now moving on to PRGN-2012, which is our first AdenoVerse 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 IND application to initiate the Phase 1 clinical trial and we expect initial dosing first half of 2021. Finally, in January, we presented pre-clinical data for PRGN-2013, our AdenoVerse therapy for hepatitis B HBV infection.

This therapy incorporates novel HBV antigen design in a gorilla adenovector. The data showed that PRGN-2013 induced superior cytotoxic T-cell responses against more HBV epitopes in mice than a competitor vaccine candidate and decreased plasma hepatitis B surface antigen levels, the key marker for chronic HBV infection. We are very encouraged by this data and 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 a combination. We expect to provide 12-month follow-up data in the adult arm in the Phase 2a portion during the first half of 2021 and in the adolescence arm in the Phase 2a 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 toward the BLA.

Finally for INXN-4001, our Phase 1 trial for heart failure, we have completed 12-month follow-up in the Phase 1 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?

Tom Samuelson -- Head of Financial Strategy

Thank you, Helen and good afternoon to our stakeholders on the call. As Precigen 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, Trans Ova Genetics and Precigen 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 million 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 MBP Titan. These assets required more than $80 million 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 AEBITDA at our two main revenue generating subsidiaries, Precigen 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 Precigen 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.

Helen Sabzevari -- President and Chief Executive Officer

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 question.

Questions and Answers:

Operator

[Operator Instructions] Our first question comes from Jason Butler with JMP Securities. Please go ahead.

Jason Butler -- JMP Securities -- Analyst

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 of the response or anything about patient characteristics or tumor cytogenetics that could inform future development or patient selection?

Helen Sabzevari -- President and Chief Executive Officer

Oh, absolutely. Thank you, Jason and glad to have you on the call. Definitely, so this patient is -- we are really excited. It's the first patient that was treated in lymphodepletion arm of the PRGN-3006 and at 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 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 incomplete hematological recovery, mainly it's referred to the platelet count that has not been back to the full level and that would consider this complete CR without the immunological recovery, but the patient, the bone marrow for these patients -- the bone marrow blast has to be below 5% and the patient achieved that. It went below the 5%. 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 ultimate basically 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 and the first patient that we have treated in a lymphodepleted arm.

Jason Butler -- JMP Securities -- Analyst

That's great, thanks a lot. And then just one more from me. Just in the context of the logos 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?

Helen Sabzevari -- President and Chief Executive Officer

Yeah, so as we have communicated in a non-lymphodepletion arm, we are already in a third dose cohort, which is 1 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 expansions.

Operator

Our next question comes from Ben Burnett with Stifel. Please go ahead.

Helen Sabzevari -- President and Chief Executive Officer

Well, first of all, Ben, I want to welcome you to the group. Thank you very much to being on the call and as our analyst from Stifel. Thank you.

Ben Burnett -- Stifel -- Analyst

Great. Thank you. Thank you for the welcome. I appreciate that. Just two questions. Actually wanted to follow-up on the previous discussion around the CRi 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?

Helen Sabzevari -- President and Chief Executive Officer

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 a 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 we have received up to I believe at least two months after the infusion and we saw expansion -- very good expansion and persistence of the cells and obviously also in the bone marrow because the patient carry 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.

Ben Burnett -- Stifel -- Analyst

Okay, that's great color. I appreciate that. 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 is this readout a good proxy for what's happening in the primary tumor or do you think it maybe is a better proxy for CAR-T activity at like distant metastatic size?

Helen Sabzevari -- President and Chief Executive Officer

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 the -- actually the number of the CAR-Ts in the blood. So I don't think the kinetics of the expansion necessarily is being presented as well in the blood because we are infusing the cells intraperitoneally. Whereas what we have seen up to date and we showed in December some of the patients on that, it's definitely the direct effect on the tumor lesions, which is quite impressive for these patients that they had upwards of seven failures 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 distant like bladder for instance lesion.

So I think that will be the major readout, but still we have been able to show in the blood that there is expansion persistent versus 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.

Ben Burnett -- Stifel -- Analyst

Super interesting. Okay, thank you very much.

Helen Sabzevari -- President and Chief Executive Officer

Sure.

Operator

Our next question comes from Nick Abbott with Wells Fargo Securities. Please go ahead.

Helen Sabzevari -- President and Chief Executive Officer

[Speech Overlap] I would like to welcome you as well.

Chuck Whitesell -- Wells Fargo Securities -- Analyst

Well, thank you. Yes, it's actually Chuck Whitesell on for Nick Abbott. Thank you for the welcome and Nick appreciates that as well. I had two questions, one is for your AdenoVerse platform specifically PRGN-2009, could you elaborate on how you're differentiated from other HPV cancer vaccines?

Helen Sabzevari -- President and Chief Executive Officer

Absolutely. So first of all, our platform, the AdenoVerse platform is differentiated in the sense that this gorilla vectors, because there is no seropositivity or very little seropositivity in humans, you can give them number of times, unlike at five [Phonetic] or other retro viruses or in general. Here, you can keep injecting and preclinically before we had shown that you can expand the T-cells in pre-clinical 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 target 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 JPMorgan, we showed that the preliminary data from NCI not only the safety and excellent safety that we have shown with the PRGN-2009 in monotherapy, but also the fact that you can now repeat those tests [Phonetic] 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 through what we have for PRGN-2009 versus all the other competitors.

Chuck Whitesell -- Wells Fargo Securities -- Analyst

Great. Wonderful. And my second question is, could you elaborate on your general strategy for partnering certain assets?

Helen Sabzevari -- President and Chief Executive Officer

Absolutely. So our philosophy in regards to the partnering is actually we -- especially me coming from big pharma, you have to be aware that the assets has to be at a certain level of maturity, in general, to be able to be presented and also always data is what is 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 pre-clinical 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 pre-clinical 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 and infectious diseases. This asset after finishing the Phase 1 for 4001 with a very good safety and very encouraging data from the Phase 1 which we will be reporting this year, we saw fit 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 opportunity and the maturity of the datasets and with that in mind and also the partnerships that they come up, we would evaluate and strategically make a decision as we move.

Operator

Our next question comes from Eric Joseph with J.P. Morgan. Please go ahead.

Hannah Adeoye -- J.P. Morgan -- Analyst

Hi, Eric. 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 and is there any interest of actively pursuing a more rigorous regimen.

Helen Sabzevari -- President and Chief Executive Officer

Well, actually we don't need to pursue more rigorous regimen of lymphodepletion to be honest with you, because even in our non-lymphodepletion arm, we have seen a 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 UltraCAR 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 increase of Perforin, which is directly -- it's attached to the cytotoxicity of the UltraCAR-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 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.

Operator

[Operator Instructions]. Our next question comes from Arthur He with H.C. Wainwright. Please go ahead.

Arthur He -- H.C. Wainwright -- Analyst

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 runway, could you give us an update on your business strategies regarding the Trans Oval and Exemplar. Thank you.

Helen Sabzevari -- President and Chief Executive Officer

I think on the patient 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 patient. The patient I can just tell you as long as we had followed and gotten reports in 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 we have -- Tom can speak to that as we have mentioned, we have a good runway now to 2023. And Tom, if you want to add?

Tom Samuelson -- Head of Financial Strategy

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 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 though.

Arthur He -- H.C. Wainwright -- Analyst

Okay, thank you. Thank you very much.

Operator

Our next question comes from Justin Walsh with B. Riley Securities. Please go ahead.

Helen Sabzevari -- President and Chief Executive Officer

Welcome Justin as well.

Justin Walsh -- B. Riley Securities -- Analyst

Hi, thank you for taking the question and congrats on the progress. So my first question is related to the PRGN-2009, 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 2 portion with the HPV-positive oropharyngeal and sinonasal squamous cell cancer, but what about the other HPV driven cancers and obviously, cervical cancer is at the top of the list there.

Helen Sabzevari -- President and Chief Executive Officer

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 number of patients that had cervical cancers and in the design of PRGN-2009 and the epitopes that covers, actually lends itself to not just only head and neck, but all this and currently we are looking at expansion and entering to the cervical cancer, because that's one area that is 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 a 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 by the -- when I was heading the vaccines were being generated.

The platforms have advanced and especially this adenovirus 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 specifics over and over again and this allows sort of expanded coverage of the epitopes. So we are moving toward not only the head and neck in Phase 2, 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 1 and I would say stay tuned. It's going to be very exciting.

Justin Walsh -- B. Riley Securities -- Analyst

Thank you. That's very helpful and last question for me. So your vision of having a patient having tumor-associated antigens 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 the CAR need to go through regulatory review or might regulators think of it more like a neoantigen approach?

Helen Sabzevari -- President and Chief Executive Officer

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 new antigen but with the difference here that you don't need to produce neoantigen, right? Identify the neoantigen and then built TCR for weeks upon weeks and multiple TCRs that you might need. By having UltraVectors 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 MUC16, you can have mesothelioma and you can have MUC1, any of these can be shared for number of indications 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 tumors 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 to 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 dose.

Operator

This concludes our question-and-answer session. I would like to turn the conference back over to Helen Sabzevari for any closing remarks.

Helen Sabzevari -- President and Chief Executive Officer

Thank you very much. First of all, I want to thank everyone for taking the 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.

Operator

[Operator Closing Remarks]

Duration: 49 minutes

Call participants:

Steven Harasym -- Head of Investor Relations

Helen Sabzevari -- President and Chief Executive Officer

Tom Samuelson -- Head of Financial Strategy

Jason Butler -- JMP Securities -- Analyst

Ben Burnett -- Stifel -- Analyst

Chuck Whitesell -- Wells Fargo Securities -- Analyst

Hannah Adeoye -- J.P. Morgan -- Analyst

Arthur He -- H.C. Wainwright -- Analyst

Justin Walsh -- B. Riley Securities -- Analyst

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