Good day and welcome to Precigen Fourth Quarter and Yearend 2020 Financial Results Conference call. [Operator Instructions]. I'd now like to turn the conference over to Steven Harasym. Please go ahead.

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'll 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 our forward-looking 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'll now like to turn the call over to Dr. Sabzevari.

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 am 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 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 operation 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. 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 that will be 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 cohort, an 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 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 cost of time and contamination risk. This system was cleared for clinical manufacturing use by the FDA and we have started dosing patients with UltraCAR-T cells manufactured using UltraPorator for both our hematological and solid tumor CAR-T trials. As for the trial, PRGN-3005 targeting unshed MUC16 at Phase 1/1B trial in patients with ovarian cancer. Initial data presented in December for PRGN-3005 UltraCAR-T cells showed encouraging and persistent results after low-dose IP infusion without lymphodepletion. In addition, 50% of patients treated three out of six had either dose level one or dose level two, with low doses between six 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 recent 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 and the IV arm of PRGN-3005 Phase 1 trial concurrently with IP. I am happy to announce that we have successfully dosed the first patient in the IV arm. 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, PRGN-3005 cells showed encouraging expansion and persistence in peripheral blood after low-dose infusion between 1 million and 29 million UltraCAR-T cells in both the lymphodepletion and non-lymphodepletion cohorts as well as the ability to track it, expand and persist in bone marrow. Furthermore, PRGN-3006 treatment indicated clinical activity as evidenced by the reduction in AML tumor blast levels. The potential and strength of this platform was highlighted at the ASH 2020 case study of a patient with multiple prior treatment failures where UltraCAR-T persisted for more than seven months after very low dose only a 24 million total UltraCAR-T cells infusion without prior lymphodepletion. This patient showed a decline in blood levels 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 one 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 subsequently received a hematopoietic stem cell transplant and is doing well, which according to Dr. Solomon is a very encouraging outcome. We're simultaneously enrolling in the dose escalation phase of both the lympho and non-lymphodepletion 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 of the 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 rebuilding 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 tumor. We believe this is the only platform that has the flexibility to generate multiple autologous UltraCAR-Ts for patients, re-dosing if needed at the same time it has the potential to do so at the lowest cost. This is a very exciting prospect for advancing personalized medicine. Now let's turn to our immunotherapy platform, which is based on our gorilla adenovector library; it has a high payload capacity and provides the ability to read those bold 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 the Phase I monotherapy dose escalation arm of the trial. All six patients enrolled in the Phase I monotherapy arm have received multiple PRGN-2009 doses and to date the repeated administration has been well-tolerated with no dose limiting toxicity. Preliminary co-relative analysis showed that 100% of three out of three 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 responses. This highlights the potential differentiation of the adenovirus platform compared to existing treatments. We are 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 timeframe. Now moving on to PRGN-2012, which is our first adenovirus program targeting infectious diseases. 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 application to initiate the Phase 1 clinical trial and we expect initial dosing in the first half of 2021. Finally, in January, we presented preclinical data for PRGN-2012 or 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, a key marker for chronic HBV infection. We're very encouraged by this data and the opportunity to advance this program toward the clinic in infectious diseases. Now moving to a Phase 1b/2a trial of AG019, which is based on our Active Biotics platform. We have completed enrollment in AG019 for treatment of T1D in the Phase IIA 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 the 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 2a during the first half of 2021 and in the adolescent arm in the Phase 2a portion during the second half of 2021. We're 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 I trial for heart failure, we have completed a 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 partnership 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 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 cost by 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 Okinawan Specialty, an operation 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 EBITDA, our two main revenue-generating subsidiaries, Precigen Exemplar and Trans Ova Genetics, improved by a combined $14.6 million. We committed in 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 therapeutic 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 operating 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.

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 therapeutics and technology platforms forward as quickly as possible and our entire team remains committed to achieving the goals on behalf of the patients and our shareholders, which motivate us every day. Operator, you may now open the line for questions.

Thank you. We'll now begin the question-and-answer session. [Operator instructions] Our first question comes from Jason Butler with JMP Securities. Please go ahead.

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

Thank you, Jason, and glad to have you on the call. Definitely, so this patient is we're really excited; it's the first patient that was treated in a lymphodepletion arm of the PRGN-3006 and with very low dose. To be exact, actually it was 8.7 million cells that this patient received autologous or overnight about that the patient received. The patient was dosed in October, I believe, and when we gave the R&D, the patient was not in a really good state, yet let's put it this way; the patient was considered MLS which was very close to ACR but hematological correspondence had not been evaluated. In January, the patient Dr. Solomon considered the patient as the CRI, which is the complete response with incomplete hematological recovery. Basically, in these patients when they used that incomplete hematological recovery mainly it's referred to the platelet count that had not been back to its full level that would consider this complete PR without the immunological recovery. But the patient, the bone marrow for this patient had to have a blast count below 5% and the patient achieved that. It went below the 5%. There had to be no blast cells in the blood and there were no blast cells in the blood and consequently the patient was now basically after reevaluation eligible to receive the bone marrow transplant and this is very exciting because this is the ultimate result for the patient; these patients in AML who 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're really excited, especially with such a low dose of our UltraCAR-T in the first patient that we have treated in a lymphodepleted arm.

And then just one more for 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?

So as we have communicated in a non-lymphodepletion arm, we have already made the first dose cohort which is 1 million per kilogram and we're obviously finishing that and following those patients and then in a lymphodepletion, we have entered into 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 a lymphodepletion and non-lymphodepletion at what dose and actually what treatment we will be going for the expansion.

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

Thank you for the welcome and 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 can maybe talk about some of these clinical events that you mentioned at the CRI and the patient being deemed for transplant. How did that correlate with some of the cell expansion data? Like when they wanted to transplant, did they still have the CAR-T in their system?

So we've been able to follow this patient for a significant 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 their cells. We have not -- unfortunately, we don't have a direct cell sample before this transplant from this patient, so I cannot answer that question. But during the time of expansion and during the early months that we actually received up to, I believe at least two months after the infusion, we saw expansion, very good expansion and persistence of T cells and obviously also in the bone marrow because the patient had a majority of the blast cells in the bone marrow. One of the criteria for a complete response is that the bone marrow blast count has to go well below 5%, and that's exactly what happened.

Maybe one other one, just one the ovarian cancer program, so for this next update I guess what are expecting to see in terms of cell expansion data 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 may be a better proxy to observe like this metastatic sites?

Excellent question, Ben. Actually, because in this first we are infusing IP and not IV therefore, when we are reading, we are reading actually the number of the CAR-T in the blood. So I don't think the kinetic of expansion necessarily is being presented as well in the blood because we're infusing the cells intraperitoneally. What we have seen up to date and we showed it in December some of the patients, we definitely did have a direct effect on the tumor lesion which is quite impressive for these patients that they had upwards of seven failures of treatment 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 a 50% reduction in the total tumor burden number of CRs and PRs in distant lesions. I think that will be the major readout, but still we have been able to show in the blood that there is expansion persistence versus in one of the patients we could follow up to three months and we could see this out. What is exciting and we just started, and I think we communicated this in this call was that the FDA now based on the safety has allowed us to concurrently initiate the IV. If you recall, the FDA had asked us to finish the IP completely before we start the IV. Now we have received 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 clarity on the kinetics of the expansion and persistence in that way as well.

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

It's actually Chuck Whitesell on for Nick Abbott. Thank you for the welcome and Nick appreciates those as well. I had two questions; one is for your AdenoVerse platform, specifically PRGN-2009 could you elaborate on how you're differentiating from other HPV counter vaccines?

So first of all, our platform, the AdenoVerse platform, it's differentiated in a sense that these gorilla vectors, because there is no zero positivity or very little zero positivity in humans, you can give them number of times unlike Ad5 or other retroviruses or in general. Here you can keep interjecting and pre-clinically, before we had shown that you can expand the T-cell 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 antigen that we targeted in HPV. Generally, there are a second antigen that is targeted and the majority of all of the companies use the same. What we have done over the last year was really expand the breadth of the epitope that are in our PRGN-2009 and what we have shown with that is that basically we incorporated a new part of the virus 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 at JPMorgan we showed that the preliminary data from NCI; not only the excellent safety that we have shown with the PRGN-2009 in monotherapy, but also the fact that you can now repeat dose and exactly as we have predicted you keep increasing the number of T-cells and I think that is what makes a lot of difference and a differentiation factor for what we have for PRGN-2009 versus all the other competitors.

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

Absolutely, so our philosophy in regard to partnerships is that we—especially coming in 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. Also, always, data is what speaks for the asset, especially when you get to the clinical level. 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 believed have a high ability for success with the patient and then build a very solid preclinical and eventually clinical data launches, and that's what we have done over the period of time. Regarding 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. These assets after finishing the Phase 1 for 4001 with a very good safety profile 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 inter, and as I mentioned, we are in discussions for a partnership for instance for that asset. So I think we're continuously evaluating our portfolio and looking at the value of opportunities and the maturity of the dataset, and with that in mind, and also the partnerships that come up, we evaluate and strategically make decisions as we move.

[Operator instructions] Our next question comes from Eric Joseph with JPMorgan. Please go ahead.

This is Hannah on for Eric. Thanks for taking our question. First with PRGN-3006 given the safety data you're seeing to date, just wondering if you would consider any changes to the lymphodepletion regimen that's being used and do you have any interest in pursuing a more rigorous regimen?

Well actually we don’t need to pursue a more rigorous regimen of lymphodepletion, to be honest with you because even in our non-lymphodepletion arm, we've seen very exciting preliminary data. We reported on a patient that basically came out of the hospital 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 basic samples that we have, but also the patient showed that in conjunction with the expansion and persistence of the UltraCAR-T directly in the patient, the blast cells in the peripheral blood and bone marrow decreased. That was also in conjunction with the biomarker increase in the peripheral blood which is directly attached to the cytotoxicity of UltraCAR-T cells against tumors. 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. So I don't see any reason for a more aggressive lymphodepletion.

[Operator instructions] Our next question comes from Arthur He with HC Wainwright. Please go ahead.

I had two questions, first regarding the 306 could you just give us an update on the follow-up data for the patients in the case study presented at ASH last year and the second question is considering you guys already secured a decent cash along the way, could you give us an update on your business strategies regarding Trans Ova and Exemplar? Thank you.

I think on the patients in the ASH I believe this I have to refer back to Dr. Solomon for a follow-up. So just I want to make sure that I don't give any kind of information that is wrong. So the update on that patient, I can just tell you as we have followed and gotten reports in R&D which we reported at that time. So I'll definitely look into that and get back to you in regard to that update. As for 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?

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. 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. So I wouldn’t say we have any particular updates on the strategic side for both businesses beyond what I've shared.

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

So my first question is really the PRGN-2009, have you put any thought into what signals you need to see in the various indications for the asset? I know the NCI trial is moving to a 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 that were there?

Excellent question. Actually, we're really excited about our PRGN-2009 AdenoVerse because as you know, the first six patients in this trial were all comorbid with HPV positive cancers. Among them, we also had a number of patients that had cervical cancers and the design of PRGN-2009 and the epitopes that it covers actually lends itself to not just head and neck, but all this and currently we are looking to expand and enter cervical cancer because that's one area that is very, very exciting. One of the things I would like to mention in regard to PRGN-2009, as I have mentioned before, this platform allows us really to generate specific T-cells with PCRs directly in patients and with the ability to keep giving this vaccine over and over again. 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 AdenoVerse 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-cells over and over again and this allows expanded coverage of the epitopes. So we are moving towards not only the head and neck in Phase II but also in cervical cancers in the upcoming year and we will be addressing this definitely in the second half of the year as NCI will be reporting on the results of Phase 1 and I would say stay tuned. It's going to be very exciting.

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?

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 approach but with the difference here that you don't need to produce neoantigens, right? Identify the neoantigen and then build TCRs 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 numerous indications across lung, pancreatic, ovarian, bladder cancer and you can see that basically with overnight you can produce any of these or combinations of these. The important part is we have already gone through the manufacturing and have shown that we can do this overnight and perform quality control the next day and infuse to the patient. As we speak, we are 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 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. Your point about neoantigens is 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 required and we can repeat dose.

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

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 interactions with our analysts and our investors. Thank you.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.