Good morning, and welcome to the Precigen Second Quarter and First Half 2023 Financial Results and Business Update Call. Please note, this event is being recorded. I would like to turn the conference over to Steve Harasym, Vice President, Investor Relations. Thank you, operator. Thank you for joining us today. With me are Dr. Helen Sabzevari, President and CEO of Precigen, and Harry Thomasian, our CFO. Helen will provide details on today's releases and an update on our portfolio, after which Harry will review our second quarter and first half 2023 financial results. Following our prepared remarks, we will open the call to Q&A. Before we begin, let me briefly review our forward-looking statement. 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 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? Thank you, Steve, and thanks to all of you for joining us today. Today is a very exciting day for Precigen, and I'd like to provide you with the significant progress that we have made in the first half of this year. I will discuss two major topics today. One is the positive regulatory developments, which we announced this morning for our lead program, PRGN-2012, in an orphan rare disease setting in RRP. Secondly, the portfolio prioritization to focus our efforts to accelerate the development of PRGN-2012 towards commercialization, while we continue advancement of our other key programs and extend our cash runways to 2025. With that in mind, let's go to slide number four. We have been, as you know, active in discussions with the FDA to align on a rapid regulatory path for PRGN-2012, given the high unmet need in RRP patients. There is no approved drugs, and the only treatment options remains is recurring surgeries that are a major burden for these patients, both physically, health-wise, economically. We are pleased to announce that the FDA has confirmed that the ongoing single-arm phase I and II study will serve as the pivotal study to support BLA submission for an accelerated approval. At the same time, there is no additional randomized control study will be required to support accelerated approval. We have agreement with the FDA on the endpoints from the ongoing phase I and II study to support the BLA submission, which includes the complete response rate, which is the percentage of patients with no surgical intervention required during the 12 months following the treatment, and an immunological surrogate marker for HPV-specific T-cell responses, which, by the way, has been already implemented both in phase I and phase II. Precigen also has reached an agreement with FDA that a single-arm confirmatory study needs to be initiated but not completed, and that's very important, prior to the submission of the BLA. At the same token, we are very thankful to the FDA, and they have even encouraged us to add and evaluate the inclusion of the exploratory arm to the confirmatory study for a repeat dosing for the non-complete responders to potentially expand the label. We are very excited about that. The ability of the ongoing phase I and II to serve as a pivotal for accelerated approval can significantly reduce the developmental time to licensure. You can imagine what that does that mean for our patients, because now the randomized phase III are not required here, and we can move much faster, especially as I will go through the path for the licensure for us. To further expedite the development of PRGN-2012, we are preparing Precigen's in-house gene therapy manufacturing facility to produce drug substance for commercial launch. Why are we doing that? Simply, this allows us to maintain control of manufacturing in-house. We leverage our internal expertise, and we reduce the cost and timelines due to reduced reliance on a contract manufacturers. If we look at what has happened and take a moment to recognize the current status of the ongoing single-arm phase I and II study, is, as you have seen and we have reported the data, the phase I has been completed and the enrollment and dosing in the phase II portion of this study is also completed. phase II patients follow-up, data collection, and the completion is anticipated by the second quarter of 2024. The phase I data that we presented in January has shown 50% of our patients, that they were treated at the dose level two, have a complete response, and that means they needed no further surgery in the follow-up of 12 months. Today, we are pleased to report that all complete responders from the phase I, they remain surgery-free with the minimum follow-up of 18 months, and the responses are still ongoing. We are very pleased and excited about the promise of the PRGN-2012 for RRP patients who receive numerous surgical procedures in absence of therapeutic in their lifetime. That can be very harmful, financially burdensome to the patients and overall, the healthcare system. Getting this therapy as quickly as possible to the patients who needs relief is our highest priority, obviously. I like to acknowledge at this point the tremendous effort of Precigen team and our investigators and collaborators to move the PRGN-2012 from discovery phase to a recognition as a pivotal trial on a path for an accelerated approval in about 3 years, including the pandemic years. With that in mind, if we look at the slide number five, what I would like to highlight is what differentiates PRGN-2012 and the AdenoVerse platform from the rest. We have seeked the market and the KOL research, and we have listened to what our KOLs have been telling us, that what is unique and differentiated about this molecule and this platform? As is, you can see in this slide, one thing that really stand out is the mechanism of action that has been seen as very promising. The physicians describe the PRGN-2012 mechanism of action as promising, and particularly, they are impressed with this molecule to generate a T-cell responses that specifically targets HPV 6 and HPV 11 viral type type, which is the root cause of RRP. This is what is important about this therapy, because it goes to the root of the problem, which is the infection in the patients that allows this recurrence of the papillomas in a very, very dangerous regions on vocal cords and trachea and even in the lungs. Secondly, there is a very favorable safety data. We have shown some of the safety data from phase I, and as you can see, and it was mentioned, the safety is grade 1 and grade 2. It's flu-like vaccination. This is extremely favorable, obviously, for the patients, and the physicians, they appreciate that tremendously. Especially that some of the patients in the future will be pediatrics, and this clearly, it's an important factor. Finally, the reduction in the number of surgery. I think we have heard from our patients continuously that even reduction in 1 less surgery, it's fundamental to them. Now, having complete responders that over 12 months and ongoing, they do not require any surgery. By the way, we have been in the most severe patient population, which they require more than three surgeries per year, and being able to accomplish that. This is quite exciting, and we are really happy for the patients. Finally, this is a platform that with a very attractive route of administration. What does that mean? These vaccines have been given subcutaneously to the patients. You can imagine now the patients, that they have to go continuously under surgery, now they can go to their physician, basically office, and receive a subcu injection, very similar to a flu injection, and this is quite a accomplishment and a differentiation. With that in mind, if we look at the slide number six, on top of this slide, what you see is the scenario that we are describing in regard to the patient. You are looking at the normal, basically, vocal cord throat of a normal individual, then on the right-hand side, you are looking at what the RRP patient suffers from. These patients are dependent on a surgery only continuously to remove these benign tumors, just to be able to talk or just to be able to breathe. Can you imagine having a child that you have to do this continuously on a monthly basis, take them for this kind of surgery? The, obviously, there are no approved therapeutics for the RRP, and this is the importance of the decision of FDA that allowing us to go for accelerated approval, which I'm thankful to the FDA in general, for recognizing the need of the patients and also the innovative studies that can be addressing that need. As we have said, the current standard of care is repeated surgeries, and this does not affect the underlying root of this indication or this disease. Due to the chronic nature of the disease, RRP patients can undergo hundreds of surgeries during their lifetime, and these repeated surgeries, as I mentioned before, can worsen the condition of RRP, as it can increase the spread of HPV virus and can result in a significant comorbidity, including loss of vocal functions. There is a significant economic and quality of life burden of this disease throughout the lifetime of RRP patients. As you can see on the slide, there are, and these are approximate numbers, that in the U.S., there are 10,000, at least, cases of adult and 6,000 of juvenile. In ex U.S., there is a much larger population, upwards of 60, and we really don't know the exact number of juveniles. These are parts of the research studies that we will be doing as part of the projected market for the U.S. and ex-U.S. With the potential now to accelerate towards becoming a commercial estate company and considering the challenging capital markets at this time, we believe that we should be laser-focused on expediting the 2012 path to commercialization. By doing this, we believe that we can best position Precigen for near-term success in this current environment. On slide number 7, we are highlighting some of the actions that we are taking to realign our resources and pipeline to realize a substantial savings, especially with respects to external CRO spending and the SG&A costs, compared to the original budget estimates. Harry will further expand on the cost-saving measures we are taking over the past years and the current years. Just to mention, what we are now focused is not only to accelerate the path for PRGN-2012 without damaging the very important other programs that we have, but also extending our cash runway, which allows us to get to the readouts, specifically and beyond, by various means. Let's go through some of these actions. We are, first of all, reducing the cost of the clinical CROs for outside, reducing the number of the sites that will be involved in various programs, as I will go through them. Definitely, we have been reducing our SG&A costs and continue to do so, and Harry will highlight that. At the same token, we are redirecting our R&D team to focus on CMC and translational clinical research activities. We have a highly productive and cross-trained team, which currently, as we speak, are involved in shifting focus in order to address the CMC and translational, clinical translational work required to support PRGN-2012 path to approval. What does this do for us? First of all, there is no reduction in our R&D force. Secondly, this allows us to hold on to our talent without any, again, I stress that, headcount reduction. Furthermore, we will save time and money in trying to adjust the path, and this is very, very important for the very agile timelines that we have for the submission of the BLA. In regard to our PRGN-3006 UltraCAR-T program, this remains of a high priority for us. As you know, we have shown a positive data at ASH, by almost 30% objective response rate in AML patients, that they have no other therapy in front of them, and we have received a Fast Track designation from FDA. With that in view, this is extremely important program. We plan to maintain our two very productive and active sites, Moffitt and Mayo, for the ongoing phase I study for now. We plan still to present the interim phase Ib data in 2024. There will be no initiation of new sites in the remaining part of 2023. We provide further updates in upcoming quarterly calls. We also have a plan to give additional clarity on apply site expansion in 2024. In regard to PRGN-3005, similarly, we continue our phase Ia study enrollment at Fred Hutch. As part of the cost-saving measures, we plan to activate a second site under our CRADA with NCI to continue the advancement of the program without major clinical or CRO costs to us. That's very, very important for our patients as well as for this program, which is very unique. With regard to PRGN-3007, obviously, that program is investigator-initiated phase I at Moffitt, which is ongoing and continues to move. Now, in regard to what we mentioned, for PRGN-2009, especially in a cervical cancer, which is, by the way, on the same platform, adenovirus platform as PRGN-2012, we are excited to announce that the plan is to activate the NCI site first, and we leverage our CRADA for the phase II study to reduce the clinical costs for this year, and we will be giving update in early 2024 in regard to the other sites. Very important, we have been in discussions with number of parties for a non-dilutive funding opportunities, which can even further extend our runway from 2025. We have begun, first of all, the process of divesting Exemplar, and that is important. I know that Harry will speak to as we divested the Trans Ova, and that has allowed us to completely pay off our convertible notes. We are also in discussion, and very exciting discussion, in regard to our AG019 for T1D program with a number of parties, and we are planning to give our investors an update in the upcoming quarterlies. Furthermore, there are ongoing discussions on our UltraCAR-T programs for partnerships, and we will be addressing that. All of these are the means of non-dilutive fundings opportunities that we have, along with the cash runway that currently we have to up to 2025, and we believe that these non-dilutive fundings can extend that cash runway much further. With that exciting update, I'm gonna now turn the call over to our CFO, Harry, to discuss the financial updates and our strategy. Harry? Thank you, Helen, and also thank you to those participating on the call today. I'm going to speak from the notes or the information on slide 8, just to focus those on the call. This is a momentous day for Precigen, as Helen has said earlier. Combined with the announced regulatory path for PRGN-2012, we've positioned our balance sheet to provide us the cash runway to successfully transition toward a commercial stage company. As you will see in our financial statements included in our 10-Q, which was filed with the SEC earlier this morning, we've now retired all of our convertible notes. The retirement of these notes will save us $7 million per year in cash interest costs going forward. In addition, through the efficient early retirement of a significant portion of our convertible notes, we were able to save approximately $8.4 million in cash over the past 10 months. Turning now to a discussion around SG&A. Since I started with Precigen in October of 2021, we've been laser-focused on right-sizing our SG&A costs for the company we are today, and I'm pleased to announce that on a year-to-date basis, compared to the first 6 months of 2022, our SG&A costs have decreased $5.4 million or 21%. Just looking at the second quarter of 2023, compared to the same period last year, SG&A costs have decreased $3.4 million or 27%, showing a positive trend over the first quarter. A portion of these savings were due to past headcount reductions, which are now being realized. We finished the quarter with $95.6 million in cash, cash equivalents, and short and long-term investments, providing a basis for a strong forward-looking cash runway. Taking into account the reprioritization of our pipeline, as Helen has laid out, the elimination of our convertible notes, and continued focus on reducing SG&A expenses, we are now providing guidance on our cash runway into 2025, as Helen has previously mentioned. This extended cash runway is important for our shareholders as it gives us a runway well beyond the pivotal phase II data readout of PRGN-2012 in 2024, and provides us with substantial amount of time to obtain additional funding via non-dilutive methods. I will now turn the call over to the operator for Q&A. Steve? Yes, thank you. At this time, we will begin the question-and-answer session. To ask a question, you may press star, then one on your touch-tone phone. If you're using a speakerphone, please pick up your handset first before pressing the keys. To withdraw your question, please press star, then two. At this time, we will pause momentarily to assemble the roster. The 1st question comes from Jason Butler with JMP Securities. Hi, thanks for taking the question, and congrats on the progress. A couple on PRGN-2012. Just was there any discussion with FDA about the magnitude of benefit or the complete response rate you would need to show in the phase two portion to support accelerated approval? Then can you just remind us what the patient population, baseline characteristics in the phase two portion look like versus phase one? Then I have a follow-up. Thank you. Sure. Thank you. Thank you, Jason. In regard, obviously, we have had discussions in regard with the complete responses, and we are happy that the FDA has agreed with our endpoints, as I mentioned, as far as the complete responders with the follow-up of 12 months. The current design of a combination of a phase I, a phase II data for being considered as pivotal for accelerated approval. One of the things that we are very, very thankful and grateful to the FDA leadership is the fact that recognition that our phase II is the exact same design as of our phase I in the same patient population, which are basically minimum of three surgery and above, and both our phase I and II have enrolled patients with the same characteristics. We have the same endpoint, and this is part of the reason that the FDA also has confirmed that we can combine the results from our dose level 2 of phase I and the phase II, which is all dose level 2 together. Also, what is also very exciting and in part of the discussions that we have had with the FDA, the possibility to have additional arms done, dose, are not necessarily part of the confirmatory, it can be additional, that we can expand the label by going to, first of all, patients that they have less than 3 surgeries, obviously, and as little as 1 surgery even per year, and also for repeat dosing. One thing that we clearly showed in our data presentation in January, we have the overall 83% response rate in this patient population. 50% of our patients had the complete responses, and 33% of our patients reduced the number of surgeries. FDA definitely recognizes the mechanism of action here and the value of the immunological enhancement of the T-cell against the HPV and has actually encouraged us to have another arm added that we can address those partial responders by repeat dosing, which we are very thankful for that, and I think it's excellent for the future expansion of the label of this drug product. Yes, we have had discussion, and yes, we have agreement. By the way, as I mentioned, and I will mention again, the endpoints for the phase one and phase two and what we have confirmed with the FDA are the same endpoints. Great. Thanks, all. Then how should we think about re-re-repeat dosing in terms of h-how, you know, the, the timing after the first dose? Would you wait as long as 12 months, or, or could you actually give a second dose earlier, given that in some of your complete responses, at least, you were seeing it within the, what, six to 12-week time frame? Yeah, excellent question. Definitely, this is something that currently we're discussing with our investigators for this. As you can imagine, the ones that they are depending on the number of the surgeries, then if patients are not complete responders, obviously, they might after the finishing the course, which, by the way, the course of the treatment here is for vaccination, for treatment. Once that is finished, you can imagine if the patient requires a surgery two months later or so, then this is something that we can... Obviously, it's not a complete responder, and it will be at this point, it's considered partial responder or non-responder. With that, we can design various aspects, and then we can also look at the number of different patient population. This is all in discussions with our investigators, and obviously, as we design those arms, we will be going back to the FDA and also, seek further guidance, through our Breakthrough Designation, which is extremely valuable and important to us because it allows us to have a continuous dialogue in a very rapid fashion with the FDA on number of things, and this would be part of it. We are looking forward to that. Then again, I want to stress, this is not part of the confirmatory. This is optional for us, and it's actually, it's, encouraging that the FDA sees the positive, result of this that would like us to, and encourages us to even go for the extended, repeat dosing. Thank you, and congrats again. Thank you. Thank you. The next question comes from Jennifer Kim with Cantor Fitzgerald. Hey, good morning. Hi, Jennifer. Thanks for taking my- Hi, and congrats on a lot of good progress this quarter, especially with PRGN-2012. Maybe to start off on PRGN-2012, is there a way we should think about the timeline between the positive phase or if there's positive phase II data in the second quarter, starting the confirmatory st- study and then BLA submission? I know you just said that the exploratory arms aren't required for BLA submission, but would you want to submit something on that point in conjunction with the submission, or where, you know, what is your thinking currently? I have a few more after. Thanks. Yeah. Obviously, we are laser-focused, first on getting our all of the ducks in a row and moving towards the BLA submission. As you know, we have mentioned, and that's why it's one of the exciting part, the phase I and II they are single arm, is open label, is not randomized, and as the data comes in, we have the data, and clearly, we can adopt a preparation. We also have a plan through our Breakthrough Designation to move and ask for a rolling BLA, and this is part of our strategy, so for the rapid. Finally, the last is, as we mentioned, our phase II follow-up will be done by the second quarter of 2024. We have all the intention to be prepared and move as fast as we can for the submission of our BLA. In regard to the confirmatory trial, clearly our confirmatory trial and, as part of the agreement, is gonna be, again, a single-arm trial, very similar to what we have done. And that has to be just initiated, and we are already in the process of that. As you can imagine, there is really not that much discussion around the design of this or what needs to be done. As for as the arms for the extension of the label and inclusion of the patients with the lower burden of the disease or for the repeat dosing, this is something that currently we are discussing and of the design. Clearly, we will see how that can be done, but the first priority for us is to put the confirmatory in initiate that as we submit the BLA. Because it's every inch of intention for us to submit the BLA as soon as possible, as we know that these patients have no other options. We are looking forward to get this to the commercial path as soon as possible. Okay, wonderful. As you look at the, the 18-month follow-up data and those complete responders, and you're considering, you, you know, the ability for redosing, how does all of that play into your current thinking about pricing? Yeah. Yes, we are receiving the data, and we see the data as it goes. Number one, since they are still complete responders and they are in response, they have not required any redosing. Obviously, that's very exciting, and we are very, very happy for the patients. In regard to the patients that are partial responders, and we are designing the arm to address the repeat dosing, this is something that we will be addressing, and we will report on what the design would be in the upcoming months. We will be further discuss about the market and the pricing at that point, I think. Okay, great. My last question, just on your discussions with parties for non-dilutive opportunities, I think two that you, or two, focuses that you mentioned was, were AG019 and then the UltraCAR-T platform. I guess when you're talking about this discussion, what type of framework are you working under? Is this more like a research and development collaboration, or is it something where, where, you know, just trying to understand what the, the upfront in, in terms might be to you guys. Thanks. Absolutely. In regard to the AG019, as you know, we have had the phase II data, positive phase II data, and our group had also prepared for the phase III and manufacturing, commercial manufacturing. However, we had refrained from entering to the phase III because of the prioritization of the program and the cash requirement that the program had. In the past year and a half, it has become very clear in the field that especially with the approval of some of the antibodies for the antibody, teplizumab for T1D, and actually in conjunction with the data that we have shown, both as a monotherapy and in combination, that is actually superior into that treatment, the AG019 has become a center of attention. We are in discussion with number of parties, these discussions is not about the research development, I would say, on the level of AG019, for sure, and it's talking about partnerships. In regard to the UltraCAR-T, similarly, in view of the some of the data, especially on the AML that we have shown and the potential in the solid tumors, we are in discussion with a number of parties that it's take into consideration, various type of, collaboration or partnership, that, addresses, research and clinical. We will be reporting, hopefully in the near future on those. Finally, I think maybe I can add this, even though you didn't ask it, Jennifer. we are also very excited about, now the, we have started the, progress on divestiture of our subsidiary Exemplar, and I think this will be also very important in, providing a non-dilutive, cash to extend our runway from 2025 to further. Those are all the means that, by now extending our cash runway to 2025, not only we get our data readouts, but also it allows the fluctuation of these discussions that we have with various partners, to come to hopefully reality, and that will even further extend, our cash runway. Okay, very helpful. Thanks again, guys, and have a best. Thank you. The next question comes from Arthur He with H.C. Wainwright. Hey, good morning, Helen and team. Hi, Arthur. Hi, thanks for taking my question. Just a technical difficulty, I apologize if the question has been asked before. So regarding the PRGN-2012 program, I'm just curious, from your perspective, regarding the efficacy, data endpoint, what is kind of efficacy you think is, is the approval threshold? What kind of data you think is more commercially favorable? I think, from a perspective of commercially favorable, as you can see, there is nothing there. There is no other therapeutic, and from that currently exists for this patient, except number of surgeries over and over and over again in a lifetime of this. If you can imagine that if you have this disease from a childhood, it means a lifetime of surgeries and challenges with this. In that regard, we hope to be the first therapeutic on the market for this disease and patient population. In regard to the efficacy, as we have said, we have currently shown what, as far as 50% of our patients from phase I, they are a complete responders. One thing that we have discussed with the FDA, and it's very clear, that surgeries alone doesn't lead to the regression of these patients, and because if it was, then all the years that these patients had the surgeries, they should have been cured by now, which unfortunately, that is not the case. Therefore, we have the the automatic regression. It's not there, but even if you consider that it's gonna be about 10%, you will be benefiting this patient population, but we are currently standing at 50%, response rates with this. We are very excited, and by the way, this is a very deep response. Not only we have completed our 12 months of a response, but as I mentioned, from a phase I, our patients' responses, the complete responses, are ongoing and none of them have required any surgery. Yeah. Thank you for the, for the answer. Just to go a little bit deeper, regarding the, the study, when during your conversation with the FDA, did they put any, cutoff for the preexisting level of the antibody to the vector as a screening, requirement for the patient? Also, did they make a requirement for, monitoring the, the antibody, raised in the body upon the treatment? Actually, in our design, we already had immunological readouts, which included both neutralizing antibodies as well as HPV-specific T-cells. Actually, FDA very much appreciated that and recognized the importance of these readouts in conjunction with the mechanism of action that we are showing. One thing I should remind everyone in regard to the adenovirus platform, again, that as we have shown in previous data, both in regard to PRGN-2012, but PRGN-2009. Even in healthy volunteers, there is no prior or very little pre-immunity to the gorilla adenoviruses, and this is the uniqueness of this platform. One other thing that in the data with PRGN-2012 we showed in January, is that upon repeat dosing, you would not see increases in a neutralizing antibody, or if there is a slight increase, then it comes down. Therefore, you will not have the issues that you're having with Ad5 and other viruses, which basically limits you to giving this only once or at best, that you can give twice. We have shown now that data extensively for various drug products that has used the AdenoVerse platform, both PRGN-2012 and PRGN-2009. Similarly, I will remind everyone that we have shown HPV-specific T-cells from our phase I PRGN-2012, as well as phase I in PRGN-2009, which in those setting, the patients that they had HPV cancers, for instance, upon repeat dosing on a monthly basis, we have shown that you can keep enhancing the T-cell responses over the year, for instance, that the patients have been on treatment. Again, this is part of the differentiation of the mechanism of action of this platform versus all the other Ad5, the retroviruses and other platform that exists there. Oh, that's great, Helen. If I may, I can, if I may squeeze last question? Regarding the market outside the US, what's your current strategy for that? Thanks. As we just have confirmed with the FDA, we are moving rapidly with the discussions with the EMA, at the same token, with the UK and also with Japan currently, to basically position PRGN-2012 as a drug product and also on a path for licensure there. Oh, thank you. Thanks for, thanks for taking my question, and congrats on the progress. Thank you. Thank you. The next question comes from Ben Burnett with Stifel. Hey, thank you very much, and I will throw in my congrats on the progress this quarter. Thank you, Ben. I want to ask, sticking with PRGN-2012, in the past, you've provided efficacy on a number of different endpoints in addition to the 12-month CR rates. I guess, what is kind of the totality of the data that the FDA is going to look at? Are they focused on those other endpoints that you've shown? I guess maybe how focused are they on durability versus response rate? I think, very good question, Ben. First of all, the part of the endpoint that we put forward, which was very meaningful, was, we didn't go for a reduction in the number of surgeries. What we went for, upfront, and we provided, was the no resurgeries required, and we made that for 12 months, which is quite a long period of time. It was not for, three months or six months. One other thing that we did, which I believe it was seen as a very positive point, was we went to a very severe patient population, which they required three surgeries and higher. All those elements together, it not only shows the durability of the immune response, especially now that we continue, obviously, following all of our patients, and especially with our responders, we are showing they are well past 12 months, and they continue to be in full response. That speaks to the durability of that response, that 12-month follow-up and beyond now. On the other hand, the fact that we showed a mechanism of action associated with this, and I think this is, again, was appreciated by the FDA leadership, because clearly we have clinical data from the patients that are in full response, that they have generated a specific HPV 6 and 11 responses, and that obviously this is due to the treatment, as this patient did not have these responses prior to entering to the trial. I think that has become very, very important. The fact that the mechanism of action, it relates to the ability to redose with the AdenoVerse platform. That's a huge differentiation and difference between us and others, because with this, you allow now to give number of, in this case, it's a course of four, over 85 days, and by the way, it's subcutaneously given. It allows obviously, without having increased neutralizing antibodies or tremendously increase neutralizing antibodies, which will hinder the usually the T-cells, and we don't see that at all, opposite. It allowed all of that-... to be considered as the uniqueness of this drug product and also, the FDA confirmation for accepting the endpoints that we had, plus the immunological markers that we have currently have put in the trials and verified. Okay, excellent. That's, that's very helpful. I would also like to ask a question around this repeat dosing, which I think is really interesting. I guess, do you have a sense at this point, like, how many patients would kind of constitute a relevant database to adjudicate efficacy of repeat dosing? I'm assuming, would a repeat dosing just be the 4-dose course as, as or would you maybe modify that course in, in patients that you're redosing? Yeah. I think that that's a discussion that we have with our investigators. Clearly, you can think of various scenario for repeat dosing that patients, for instance, after period of when if they require surgery and becomes obvious that they are not full responders, then they can receive another course. You can imagine also a situation that this patient receives single doses throughout because, again, because of uniqueness of this platform and the fact that you can give it in a repeated fashion, as we have done for PRGN-2009, on a monthly base, and we have had patients on the trial that they received this over two years. We had complete responders that, similarly, they went to very deep responses, for over a year after receiving the vaccination with PRGN-2009. This also can become another scenario that you can be doing on a monthly basis or every three months, and this is the discussions that we have based on the immunological readouts, and we will be designing appropriate arms to address exactly that factor for a repeat dosing to address the full population. You can imagine also this is PRGN-2012 clearly is extremely important in this RRP, and for us, it's very, very important to address the whole patient population if we can, and we will do that as we also will go into the pediatric population. Okay, fantastic. If I could just maybe squeeze one more just clarification question on the- Sure. The updated cash runway, which by the way, great to hear about the cash runway and, obviously congrats on now fully, you know, retiring that, the remaining debt. Does the updated cash runway include costs associated with this expansion repeat dosing cohort and the confirmatory study, or is that separate? It, it does include, Ben, it does include some of that, not to the specificity as Helen had said. You know, we are, we're still needing to design that, but- Yeah. There is contemplation of, of those costs. Yeah. Ben, I can also say that it does include the confirmatory, because, again, our confirmatory is a single arm. I want to remind everyone it's not a randomized control phase III. It will be a single arm with a similar exact design as we have done with the phase I or phase II. The extended arms is something that we will be discussed, but that does not have to be initiated prior to BLA, and we can initiate those arms at a later point after the design. For the purposes of the cost and our runway, we have considered part of our manufacturing, as you can see, that we are switching our own manufacturing by reprioritizing our own manufacturing facility to address some of the costs, and it does take into account the initiation of the confirmatory trial. Wonderful. Thank you so much. Sure. Thanks. Thank you. The next question comes from Brian Cheng with JP Morgan. Hi, team. Thanks for taking my question this morning. From your discussion with the FDA, have they talked about how long of a safety follow-up do you need to in the ongoing study before filing? On the preparation work for filing, can you talk about, you know, whether there are any additional preclinical work that you need to tee up between now and filing that you have to work on? I have a couple follow-up. Thank you. Sure. In regard to the safety profile, it's similar to the endpoints that we have for efficacy, one year safety follow-ups, of course, and we have, we will be following these patients regardless, as they move on. Those are part of the endpoints, and as we have mentioned, and I will repeat, this product, drug product has a very favorable safety profile in all of the patients that we have treated. Very, very similar and very favorable. As far as in regard to the preclinical, the discussions, obviously, the preclinical have been already taken place prior to us going to a phase one, phase two. Obviously, as part of any BLA submission, we have to meet all the criteria that the FDA is asking for. This is part of typical of submission for the BLA, which includes, obviously, the phase II data has to be similar and to what we have seen up to this point. It has to meet the clinical endpoint. We also are in discussion with the FDA for manufacturing comparability and using our commercial material in our manufacturing, in the confirmatory trial. Those discussions are ongoing, and when we submit our BLA, of course, it has to have all those components in for the rapid review and approval, which we are hoping that we will moving towards that very rapid. Okay. Then, on the manufacturing front, can you elaborate on your commercial readiness? You know, what's needed specifically to prepare on the CMC side? You know, at the time of your anticipated launch, what, what is the capacity that we should anticipate? We have evaluated our own manufacturing facility, which, by the way, provided all of the GMP material that was used in these trials, even during the pandemic time, as you can imagine, because we started the trial of PRGN-2012 on April, I believe, of 2021. You can imagine our manufacturing had prepared that during the ongoing pandemic, which was very important, because at that point, all of the external manufacturing, they were shut down and no one could prepare anything. That's one of the importance, as I mentioned, why we have decided to move the commercial manufacturing to our own facility and make our facility commercially, basically, ready for this path and for the licensure path. We will be moving, and our material for the commercial material is as we speak, our teams are working on various aspects of comparability and also production. Since we have produced our GMP material ourselves and the processes are minimally switched, we hope that we have a very good comparability profile for manufacturing, which will be obviously presented to the FDA. We anticipate that we will be ready to launch from our commercial facility here after the approval of our BLA. I should mention that especially within the patient population that is in U.S., we believe our commercial facility has the capability to produce enough doses for that. Also, obviously, after the approval and during this process, we are also looking at further expansion. With that, we believe that we can be, our facility will be sufficient for production of the doses that is needed in U.S. Great. If I can squeeze in the last one, that'd be great. You know, just one on, you know, your overall thinking around the, the entire R&D portfolio. As you mentioned, that there are multiple potential partnerships and divesting opportunities that you currently have on the table. Given that you have a cash runway out to 2025, can you talk about, you know, how should we think of how the, the R&D portfolio will evolve over the next 12 months? What are the, you know, what are the factors that you, that you will take, you know, when you think about what to prioritize and what to partner off? Thank you. Thanks. Very clear, I think, as far as immediate partnership, is very clear that, and we had announced this previously on AG019, because we believe that this is something that is very exciting. However, Precigen does not have the cash requirements to go to extended phase III with this asset, and this is why we have the very active discussions with number of parties around AG019. In regards to our UltraCAR-T, as I mentioned, especially the PRGN-3005, because it's much, it's more advanced, and from the objective responses, it has the Fast Track and path to perhaps a rapid regulatory strategy for the AML patients there. We anticipate that the two sites, the Moffitt and Mayo Clinic, have done an excellent job in recruiting, and they will continue to do that, especially in this half of the year. We will be having the data for a phase Ib in minimum the interim data for 2024. Again, this position us and not only from a regulatory path and the decisions that have to be made for perhaps a rapid move in that direction, but also in our discussions with the groups that are right now are interested in the program and in advancement of the program towards the commercialization. The priority of our portfolio, I want to stress this, and I know Harry has stressed, we have now really minimized the costs of SG&A. We have minimized to the limit the extraneous CRO costs by not opening some of the sites. As we all know, in drug development, one of the heaviest costs is your sites that you are initiating, as it requires a large cash. By not doing that in an immediate fashion, we are saving to get to the readouts of our PRGN-2012, which is, as I mentioned, the decision of FDA, why it's so important to us, is because it eliminated requirement of a phase III, which you can imagine and appreciate, it would have taken another 3 or 4 years just to get to the point of data. Right now, we are basically. First of all, we are seeing our data from phase II as we speak, because it's an open trial. Secondly, we will finish the complete follow-up, which is the endpoint of 12 months that FDA has agreed with, by the 2nd quarter of 2024. Our cash runway is well beyond that, and it allows us to have our readouts and move with our BLA submission. From a non-dilutive fashion, definitely the discussions that we have is very productive and ongoing, and our hope is that will extend our cash runway beyond 2025. One other thing that I have to say, and I'm grateful to the team at Precigen, for dedication that they have shown. What we have done, which is not typical to a lot of other companies, is our R&D, because of their knowledge, and especially in, on a side of assay development, immunological, immunology, and clinical, they have pivoted, that they have taken a lot of the responsibilities on that side, which we do not need to now, hire a tremendous force, retrain, lose time, in order to move rapidly towards the commercialization. I think that's another, strength that Precigen has, and obviously we are utilizing. Helen, thank you. Sure. Thank you. Thank you. This concludes the question and answer session. I would like to turn to forward Dr. Sabzevari for any closing comments. Thank you. First of all, I would like to thank you for joining us today. I want to extend our thanks to the patients for participating in clinical trials, our investigators for their dedication and commitment, working on studying new therapies for our unmet needs, and to the team at Precigen, who have worked so hard over the last several years. As we have discussed today, we believe the PRGN-2012 has a paradigm-changing potential. With today's announcement of FDA alignment on a path to an accelerated approval request for our phase I, II study, this is an important milestone that brings us a step closer in our transition to a commercial-stage company and in realizing our vision of bringing life-changing therapies to patients with unmet medical needs. Given that phase I, II is fully enrolled and serves as pivotal, this sets us up to, for potentially to bring a life-changing first therapeutic option for RRP patients who have been waiting for decades for such an option. Thank you again. Now I return it to operator. Yes, thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines.