Q2 2024 Precigen Inc Earnings Call

And can I have your full name with spelling please.

Okay, and can I have your full name with spelling please?

Unknown Attendee: Sure.

David Brown: David Brown, D-A-V-I-D-V-R-O-W-N.

David Brown: David Brown, D-A-V-I-D, B-R-O-W-N

Unknown Attendee: And the company you're calling from, David? Company calling from is ARA, that is A-I-E-R-A. Thank you, one moment.

Speaker Change: Company calling from is AIRA. That is A-I-E-R-A. Thank you. One moment.

Unknown Attendee: Thank you so much. .

Speaker Change: [noise].

Speaker Change: Okay.

Speaker Change: [music].

Unknown Attendee: Good evening. And welcome to the Precigen's second quarter and first half of 2024, Penaja results call. At this time, all lines are in a listen-only mode. Following the presentation, there will be a questioning answer session. Instructions will be provided at that time for you to get up for a question. If anyone has any difficult piece here in the conference, please press star zero for operator assistance at any time. Please note, this event is being recorded.

Speaker Change: Good evening.

Speaker Change: Welcome to the precedence second quarter and first half 2024 financial results call.

Speaker Change: At this time all that.

Speaker Change: So are in a listen only mode.

Speaker Change: All of them in the presentation, there will be a question and answer session.

Instructions will be provided at that time for you to get up for a question.

Precigen? Okay.

Speaker Change: If anyone has any difficulties hearing the conference. Please press star zero for operator assistance at any time. Please note. This event is being recorded.

Unknown Attendee: And can I have your full name with spelling, please? Sure. David Brown, D-A-V-I-D-V-R-O-W-N.

Steven Harasym: I would now like to turn a conference over to Steve Harasym, Vice President of Investor Relations. Please go ahead.

Speaker Change: I would now like to turn the conference over to Steve Harrison Vice President of Investor Relations. Please go ahead.

Steven Harasym: Thank you, Jenny.

Steve Harrison: Thank you Jenny and thank you for everyone. Joining us. This afternoon with me today are Dr. Helen <unk>, President and CEO of Presage any hurry today, CNR CFO, Phil tenant, our chief commercial officer, and our Chief operating officer virtual shops.

Helen Sabzevari: And thank you for everyone joining us this afternoon. with me today, our Dr. Helen Sabzevari, President and CEO of Precigen, Harry Thomasian, RCFO, Phil Tennant, our Chief Commercial Officer, and our Chief Operating Officer, Retool Shop.

Unknown Attendee: Before we begin, let me 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 forward-looking statements. Please read the Safe Harbor statement contained in our most recent SEC filings, as well as risk factors contained in Precigen's filings.

Speaker Change: Before we begin let me 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.

David Brown: And the company you're calling from, David? Company calling from is ARA, that is A-I-E-R-A Thank you one moment. Thank you so much.

Operator: . Good evening. And welcome to the Precigen's second quarter and first half of 2024, Penaja Results call. At this time, all lines are in a listen only mode. Following the presentation, there will be a questioning answer session. Instructions will be provided at that time for you to get up for a question. If anyone has any difficult piece here in the conference, please press star zero for operator assistance at any time. Please note, this event is being recorded.

Speaker Change: Expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated by forward looking statements.

Steve Harasym: I would now like to turn a conference over to Steve Harasym, Vice President of Investor Relations. Please go ahead. Thank you, Jenny. And thank you for everyone joining us this afternoon.

Speaker Change: Please read the Safe Harbor statement contained in our most recent SEC filings as well as risk factors contained in precedence filings with that I would like to now turn the call over to Dr subsidiary Helen.

Helen Sabzevari: With that, I would like to now turn the call over to Dr. Sabzevari, Helen.

Helen Sabzevari: Thank you, Steve, and thank you for all joining us today. It is a pivotal format, Precigen, as we work hard to get what could be the first FDA-approved treatment for the devastating recurrent respiratory papillomatosis disease, or as we know it, RRP, to the market. What I would like to do at the beginning is take you through some of the key program and business highlights, and then go through some of the strategic prioritization that has been communicated recently.

Dr Helen: Thank you, Steve and thank you all joining us today.

Speaker Change: He is a pivot Joseph Ahmed prestige and as we work hard to get what could be the first FDA approved treatment for the devastating recurrent respiratory papillomatosis disease.

Helen Sabzevari: with me today, our Dr. Helen Sabzevari, President and CEO of Precigen, Harry Thomasian, RCFO, Phil Tennant, our Chief Commercial Officer, and our Chief Operating Officer, Retool Shop.

As we know it our RFP to the market.

Steve Harasym: Before we begin, let me 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 forward-looking statements. Please read the Safe Harbor statement contained in our most recent SEC filings, as well as risk factors contained in Precigen's filings.

Speaker Change: But I would like to do at the beginning is take you through some of the key program.

Helen Sabzevari: With that, I would like to now turn the call over to Dr. Sabzevari, Helen. Thank you, Steve, and thank you for all joining us today. It is a pivotal format, Precigen, as we work hard to get what could be the first FDA-approved treatment for the devastating recurrent respiratory papillomotosis disease, or as we know as RRP to the market.

Speaker Change: Business highlights.

Speaker Change: And then go through some of that is true.

Speaker Change: T J prioritization that testing communicate that.

Speaker Change: Right.

Helen Sabzevari: Let me start by talking about TRGN 2012, which is the focus now of our portfolio. As you know, PRGN 2012 is our adding-averse gene therapy that is designed to elicit immune responses directed to HPV-6 and 11 infected tumors, and to raise the immune system to both of these episodes, both HPV-6 and 11, for the treatment of recurrent respiratory papillomatosis. Let's establish some of the facts upfront in regard to our PRGN 2012. As I mentioned, it's delivered by our gorilla adenovactors, and it's a gene therapy. It's delivered subcutaneously. It does not require any kind of a divot, so it's an ease of administration that can be done at any office setting, for instance.

Speaker Change: Let me start by.

Helen Sabzevari: What I would like to do at the beginning is take you through some of the key program and business highlights, and then go through some of the strategic prioritization that has been communicated recently. Let me start by talking about TRGN 2012, which is the focus now of our portfolio. As you know, PRGN 2012 is our adding-averse gene therapy that is designed to elicit immune responses directed to HPV-6 and 11 infected tumors, and to raise the immune system to both of these episodes, both HPV-6 and 11, for the treatment of recurrent respiratory papillomotosis.

Speaker Change: Talking about <unk> 2012, which is the focus now.

Speaker Change: Of our portfolio.

P. I G. N 2012 is adenovirus gene therapy that is designed to elicit immune responses directed to HPV six and 11 in fact that tumors.

Speaker Change: And to raise the immune system to both of these epitope, both HPV six and 11 for the treatment of all.

Speaker Change: Recurrent respiratory papillomatosis.

Speaker Change: Let.

Speaker Change: Establish some of the facts upfront in regard to our PRT in 2012 as I mentioned, it's delivered by a gorilla I Didnt know baxter's.

Speaker Change: Hey, gene therapy, it's delivered subcutaneously. It does not require any kind of a device. So it's the ease of administration that can be done at any office setting.

Helen Sabzevari: Let's establish some of the facts upfront in regard to our PRGN 2012. As I mentioned, it's delivered by our gorilla adenovactors, and it's a gene therapy. It's delivered subcutaneously. It does not require any kind of a divot, so it's a ease of administration that can be done at any office setting, for instance. The second important part of this gene therapy treatment is that our gorilla adenovirus platform in general and the viral vector that is used for delivery of PRGN 2012 is differentiated from other viral vectors.

Helen Sabzevari: The second important part of this gene therapy treatment is that our gorilla adenovirus platform, in general, and the viral vector that is used for delivery of PRGN 2012, is differentiated from other viral vectors. Even though there is perception that all viral vectors are similar and therefore they can be given a very limited number of times, perhaps only once or twice, and they cannot be used in redosing because humans have pre-immunity to them. This is not applying to the gorilla adenoviruses. And why do I say simply humans either have zero pre-immunity or very little pre-immunity to these vectors, and by the way, these vectors are designed in such a way that elicit a high affinity C cell and they push towards the CDA responses.

Speaker Change: Yes.

Speaker Change: It's such an important part of this gene therapy.

Speaker Change: Treatment is that our gorilla I Didnt know worse platform in general and the viral Baxter does is used for delivery of P. O. Jan 2012 is differentiated from other why rolled baxter's, even though there is this perception that all wireless vectors.

Speaker Change: Similar.

Speaker Change: And therefore, they can be given a very limited number of time, perhaps only once or twice and they cannot be used in re dosing.

Speaker Change: Because humans have immunity to them.

Helen Sabzevari: Even though there is perception that all viral vectors are similar and therefore they can be given a very limited number of times, perhaps only once or twice, and they cannot be used in redosing because humans have pre-immunity to them. This is not applying to the gorilla adenoviruses. And why do I say simply humans either have zero pre-immunity or very little pre-immunity to these vectors and by the way these vectors are designed in such a way that elicit a high affinity C cell and they push towards the CDA responses.

Speaker Change: This is not applying to the gorilla Adenoviruses and why do I say that.

Speaker Change: Simply.

Speaker Change: Human either have zero pre immunity.

Speaker Change: Very little pre immunity to these factors.

Speaker Change: By the way. These vectors are designed in such a way that elicit a high affinity T cell and they pushed toward the Cta for responses.

Helen Sabzevari: And therefore, in a number of clinical files that we have done across various indications, we have shown over a period of time you can keep redoing with these vectors and keep enhancing the immune responses, and especially high affinity CDA key cell responses. So I just wanted to clarify that fact. This is one of the differentiating factors of our gorilla adenovirus platform in general compared to other AAV and viral delivery factors. And also this gorilla adenovirus allows us to have a high payload that can we can put many epitopes and many genes, and therefore when I say that we are targeting HPB 6 and 11 and raising immune responses to both, we have shown that, and we have shown that in the clinical trial.

Speaker Change: And therefore in a number of clinical trials that we have done across various indications. We have shown over periods of time, you can't keep re dosing with this vectors and keep enhance the immune responses, especially high affinity C. A T.

Helen Sabzevari: And therefore in a number of clinical files that we have done across various indications, we have shown over a period of time you can keep redoing with these vectors and keep enhancing the immune responses and especially high affinity CDA key cell responses. So I just wanted to clarify that fact. This is one of the differentiating factors of our gorilla adenovirus platform in general compared to other AAV and viral delivery factors. And also this gorilla adenovirus allows us to have a high payload that can we can put many epitopes and many genes and therefore when I say that we are targeting HPB 6 and 11 and raising immune responses to both we have shown that and we have shown that in the clinical trial.

Speaker Change: Cell responses. So I just wanted to clarify that this is one of the differentiating factors of our gorilla adenovirus platform in general compared to other AAV viral delivery baxter's.

Speaker Change: And also this gorilla Adenoviruses allows us to have a high payload that can become put many epitopes and many genes and therefore, when I say that we are targeting HPV, six and 11 and raising their responses to vote rehab.

Speaker Change: Shown that and we have shown that in the clinical trial.

Helen Sabzevari: Now, with that in mind, what have we done with the PRGN 2012? As you are well aware, in the PRGN 2012, is the first drug ever received a breakthrough designation and an accelerated path from FDA in June of 2023. With that designation, we also had received the orphan drug designation from the FDA as well as EMA. The interesting part of this was that because we had designed our clinical trial in such a way that first of all address the most advanced patient and most patients with the highest number of surgery and also it already put a very robust end point, not just reduction in the number of surgery but actually having safety and efficacy that leads to a complete response to the severe patient population that at least maintain for the whole year that they do not require any surgery and beyond.

Speaker Change: Now with that in mind, what have we done with the TRT N 2012, as you are well aware in the June 2012 is the first drug ever received a breakthrough designation and accelerated part from SBA.

Helen Sabzevari: Now with that in mind, what have we done with the PRGN 2012? As you are well aware in the PRGN 2012 is the first drug ever received a breakthrough designation and an accelerated path from FDA in June of 2023 and with that designation we also had received the orphan drug designation from the FDA as well as EMA. The interesting part of this was that because we had designed our clinical trial in such a way that first of all address the most advanced patient and most patients with the highest number of surgery and also it already put a very robust end point, not just reduction in the number of surgery but actually having safety and efficacy that leads to a complete response to the severe patient population that at least maintain for the whole year that they do not require any surgery and beyond.

In June of 'twenty, 'twenty three and.

Speaker Change: And with that designation. We also had received orphan drug designation from the FDA.

Speaker Change: As well as E M a.

Speaker Change: The interesting part of this was that because we had designed our clinical trial in such a way that first of all address their most advanced patient I'm, most ah patients with the highest number of surgery.

Speaker Change: Also.

Speaker Change: <unk> already put in very robust endpoint not just reduction in a number of surgery, but actually having safety and efficacy that leads to a complete response to the severe patient population that at least maintain for the.

Speaker Change: Oh, yes that they do not require any surgery and beyond.

Helen Sabzevari: As a result of that, the FDA agreed that our phase one single arm trial, as well as our phase two single arm trial, can serve as a pivotal trial and we did not have, and they have not yet been required to do any kind of randomization or placebo control trial in that setting. And that is very important. One of the aspects that I want to stress here is that the FDA agrees that these patient populations are their own best controls and therefore, by having such a higher standard of not only in the number of being in the severe patient population but also a robust end point, that negated the need for having a randomization or placebo control.

Speaker Change: As a result of that the FDA agreed that our phase one single arm trial as well as our phase two single arm trial.

Speaker Change: <unk> as a pivotal trial.

Speaker Change: And we did not have and they have no. We have not been required to do any kind of randomization or a placebo controlled.

Helen Sabzevari: As a result of that the FDA agreed that our phase one single arm trial as well as our phase two single arm trial can serve as a pivotal trial and we did not have and they have not yet not been required to do any kind of randomization or placebo control trial in that setting and that is very important and one of the aspects that I want to stress here is is an FDA agrees that these patient populations they are their own best controls and therefore by having such a higher standard of not only in the number of being in the severe patient population but also a robust end point that negated the need for having a randomization or placebo control.

Speaker Change: Trial in that setting and that is very important and one other aspect that I want to stress here.

Speaker Change: It is an FDA agrees that this patient population they are their own best controls and therefore by having such a higher standard.

Speaker Change: Not only in the number of.

Speaker Change: Is this being in the severe patient population, but also a robust endpoint.

Speaker Change: That negate the need for having a randomization or placebo controls.

Helen Sabzevari: So, let's just take a look at what happened as a result of our Phase 1 and Phase 2. We had enrolled a patient in our Phase 1 and 23 patients in our Phase 2 single arms, and we recently, in June, actually presented the full set of data both from Phase 1 as well as Phase 2 at the breakthrough session at ASCO. What was there and it was received extremely well by investigators as well as our patients and patients in RRP for a number of reasons. First of all, if you look at the primary safety of this, it's extremely favorable, and it's also the efficacy when you look at the end points for this trial, which was a complete response, meaning that the patient to go from number of surgery, which the average was 4.5 surgery per year before the treatment.

Speaker Change: Let's just take a look at what happened as a result of our phase one and phase two we had enrolled patients in our phase one.

Speaker Change: 23 patients in our phase two single arms.

Speaker Change: And we recently in June actually presented the full set of data both from phase one as well as phase two.

Helen Sabzevari: So, let's just take a look at what happened as a result of our Phase 1 and Phase 2. We had enrolled a patient in our Phase 1 and 23 patients in our Phase 2 single arms and we recently in June actually presented the full set of data both from Phase 1 as well as Phase 2 at the breakthrough session at ASCO and what was there and it was received extremely well by investigators as well as our patients and patients in RRP for a number of reasons.

Speaker Change: The breakthrough session at <unk>, and what was there and it was received extremely well by investigators as well as our patience and Ah patients in our RFP for number of reasons first of all if you look at the primary safety of this.

Speaker Change: It's extremely favorable.

Speaker Change: And it's also the efficacy when you look at that.

Speaker Change: <unk> points for these trials, which was a complete response, meaning that the patient to go from.

Helen Sabzevari: First of all, if you look at the primary safety of this, it's extremely favorable and it's also the efficacy when you look at the end points for this trial which was a complete response meaning that the patient to go from number of surgery which the average was 4.5 surgery per year before the treatment. Two completely zero surgery requirement, 12 months follow-up and we have been by the way following this patient for a durability of response which we have seen quite adorable responses in this patient population.

Speaker Change: Number of surgery, which the average was four and a half surgery party prior year before the treatment.

Helen Sabzevari: Two completely zero surgery requirement, 12 months follow-up, and we have been, by the way, following this patient for a durability of response, which we have seen quite adorable responses in this patient population. 18 out of 35 of these patients went to a complete response; that's 51 percent of the population. If you look at our secondary end point, which was the reduction in a number of surgeries, now we had 30 out of 35 patients; they reduced their number of surgeries. That's 86 percent of our population that was treated. This has been unprecedented results by any treatment for this patient population.

Speaker Change: Shoe.

Speaker Change: Completely zero surgery requirement.

Speaker Change: Months follow up and we have been by the way. Following these patients for their durability of response, which we have seen.

Speaker Change: Quite a durable responses in this patient population.

18 out of 35 of these patients went to a complete response, that's 51% of the population.

Speaker Change: If you look at our secondary endpoint, which was the reduction in the number of surgery now we had 30 out of 35 patients they reduce the number of surgeries.

Helen Sabzevari: 18 out of 35 of these patients went to a complete response, that's 51 percent of the population. If you look at our secondary end point which was the reduction in a number of surgery, now we had 30 out of 35 patients, they reduced their number of surgeries, that's 86 percent of our population that was treated. This has been unprecedented results by any treatment for this patient population. There has never been a data that was presented with this robustness of the end point as well as the safety and also being in the most severe patient populations that clearly it really is the much tougher treatment to be treated, not only in diseases in any diseases in general, we all agree.

Speaker Change: 86% of our population that was treated.

Speaker Change: This has been the unprecedented results.

Any treatment for this patient population that has never been a data that was presented with this robustness of the endpoint as well as debt.

Helen Sabzevari: There has never been a data that was presented with this robustness of the end point as well as the safety and also being in the most severe patient populations that clearly it really is the much tougher treatment to be treated, not only in diseases in any diseases in general, we all agree. So I think this was quite exciting, and as I mentioned in 2023, in June 2023 we received the accelerated approval path and the rolling BLA, and our submission, we are on track to submit our BLA by the end of this year in 2024. We also, what I'm very excited about is that we have initiated our enrollment in the confirmatory trial already and this we have reached an already agreement with the FDA that by the way our confirmatory trial are also single-armed, no placebo requirement, no randomization, which, as you can imagine, is going to make things extremely challenging for this patient if you have to randomize because each patient is their own best control and the randomization is quite challenging and this is what all the investigators believe as well.

Speaker Change: Safety.

Speaker Change: And also be in a more severe patient population.

Speaker Change: Clearly it really is a much tougher treatment to.

Speaker Change: To be three that not only in this disease in any of these general.

Speaker Change: We all equity.

Speaker Change: So I think this was quite exciting and as I mentioned in 2023 in June 2023, we received it.

Speaker Change: Accelerated approval path and the rolling BLA and.

Speaker Change: Mhm submission we are on track to submit our BLA by the end of this year in 2024.

Helen Sabzevari: So I think this was quite exciting and as I mentioned in 2023, in June 2023 we received the accelerated approval path and the rolling BLA and our submission, we are on track to submit our BLA by the end of this year in 2024. We also, what I'm very excited about is that we have initiated our enrollment in the confirmatory trial already and this we have reached an already agreement with the FDA that by the way our confirmatory trial are also single-armed, no placebo requirement, no randomization, which as you can imagine it's going to make things extremely challenging for this patient if you have to randomize because each patient is their own best control and the randomization is quite challenging and this is what all the investigators believe as well.

Speaker Change: Also but I'm very excited about is that we have initiated at our enrollment in the confirmatory trial already and this we had reached an already agreement with the FDA that by the way our confirmatory trial are also single arm.

Speaker Change: No placebo requirement no randomization, which as you can imagine it's going to make things extremely challenging for these patients. If you have to randomize because each patient is their own best control and the randomization is quite challenging and this is why.

Speaker Change: The all the investigators believe as well.

Helen Sabzevari: We already not only have initiated the confirmatory trial, which is part of submission of the BLA, but we have started the enrollment, and I have to say that we are quite taken by the number of the patients that they already have shown excitement to participate in our confirmatory trial. On the side of our commercial scale for a drug substance manufacturing, also our facility is operational and we are quite confident that we can adequately provide the doses for both US and XUS on a potential launch. And as part of our patient advocacy effort this year, we had the joint recurrent respiratory papillomatosis inaugural RRP Awareness Day on June 11 because this is actually as a result of the infection by HPV 6 and 11.

Speaker Change: The already not only have initiated the confirmatory trial, which is part of a submission of the BLA, but we have started the enrollment and I have to say that we are.

Speaker Change: Quite taken by the number of the patients that they already have shown excitement to participate in our confirmatory trial.

Helen Sabzevari: We already not only have initiated the confirmatory trial which is part of submission of the BLA but we have started the enrollment and I have to say that we are quite taken by the number of the patients that they already have shown excitement to participate in our confirmatory trial. On the side of our commercial scale for a drug substance manufacturing also our facility is operational and we are quite confident that we can adequately provide the doses for both US and XUS on a potential launch.

Speaker Change: On this side of our commercial scale for a drug substance manufacturing also our facility is operational.

Speaker Change: And we are quite confident that we can adequately.

Speaker Change: Provide the doses for both U S and ex U S on a potential launch.

Speaker Change: And as part of our patient advocacy effort this year.

Speaker Change: We had the joint recurrent respiratory.

Speaker Change: Papillomatosis inaugural our RP awareness day on June 11, because.

Speaker Change: This is actually as a result of the infection by HPV six and 11. Therefore June 11, and we are really excited that we have been working very very closely with our RFP Foundation to advance this innovative treatments for the.

Helen Sabzevari: And as part of our patient advocacy effort this year we had the joint recurrent respiratory patholumatosis inaugural RRP Awareness Day on June 11 because this is actually as a result of the infection by HPV 6 and 11. And therefore June 11 and we are really excited that we have been working very very closely with RRP Foundation to advance this innovative treatment for the patients in this setting.

Helen Sabzevari: And therefore June 11, and we are really excited that we have been working very, very closely with RRP Foundation to advance this innovative treatment for the patients in this setting.

Speaker Change: Patients in this study.

Helen Sabzevari: So, with that in mind, just to recap what we have done and why we are so excited and so focused on PRGN 2012 is we have established a very differentiated, innovative therapy that doesn't require any device. You can give it subcutaneously. It elicits immune responses to the root cause of these benign tumors, which take place on the trachea or the vocal cord of this patient and the cause of devastating scenario for this patient. And as a result of the mechanism of the action and the safety and safety that we have shown, these patients get 51% of this patient going to a complete response, 86% of them reducing their number of surgery.

Speaker Change: So with that in mind just to recap what we have done and we are why we are so excited and so focus on PRT had 2012 is we have established a well differentiated innovative therapy that doesn't require any device you're playing in.

Helen Sabzevari: So with that in mind just to recap what we have done and why we are so excited and so focused on PRGN 2012 is we have established a very differentiated innovative therapy that doesn't require any device. You can give it subcutaneously. It elicits immune responses to the root cause of these benign tumors which take place on the trachea or the vocal cord of this patient and the cause of devastating scenario for this patient.

Speaker Change: Given subcutaneously it elicit immune responses to the root cause of these benign tumors, which take place on the trachea or the vocal cords of this patient cause a devastating scenario for this patient.

Speaker Change: And as a result of the mechanism of the action and the safety advanced safety and.

Speaker Change: Is that we have shown these patient <unk>.

Speaker Change: 51% of these patients going to a complete response, 86% of them reducing their number of surgery. The durability of the response. The median has not been Richard at this point is 20 months.

Helen Sabzevari: And as a result of the mechanism of the action and the safety and safety that we have shown these patients we get 51% of this patient going to a complete response 86% of them reducing their number of surgery. The durability of the response the median has not been reached at this point is 20 months or phase one patients that they have been obviously have a much longer follow up have surpassed 32 months of the durable responses and have not required any surgery.

Helen Sabzevari: The durability of the response, the median has not been reached at this point, is 20 months, or phase one patients that they have obviously have a much longer follow up, have surpassed 32 months of the durable responses and have not required any surgery. So with that, we believe that this and we are extremely excited that this drug has the potential to be quite effective for RRP patients and the first drug has the potential to receive the first drug ever approved by the FDA.

Speaker Change: Phase one patients that they have been obviously have a much larger longer follow up have surpassed 32 months.

Speaker Change: The durable responses oven has not required any surgery. So with that we believe that we are extremely excited.

Speaker Change: That this drug has the potential.

Speaker Change: To be quite effective for RP patients and the first strike.

Speaker Change: Potential to receive the first strike ever approved by.

Helen Sabzevari: So with that we believe that this and we are extremely excited that this drug has the potential to be quite effective for RRP patients and the first drug has the potential to receive the first drug ever approved by the FDA.

Speaker Change: By the FDA. So in that process. We also have been preparing for the potential commercialization of <unk>.

Helen Sabzevari: So in that process we also have been preparing for the potential commercialization of the drug in 2025, and in that setting I am thrilled to welcome Phil Tenant as the Chief Commercial Officer for our company. We have been very excited that Phil has joined the leadership. And now currently leading all activities around the commercialization for Piagin 2012, and I would like to hand over actually to Phil to hear from him and his perspective on the commercial the path of Piagin 2012.

Phil Tenant: In 2025 and in that setting I am thrilled to welcome Phil tenant as the Chief commercial officer for our company and we have been very excited that Phil has joined the leadership and now currently leaving all active.

Phil Tennant: So in that process we also have been preparing for the potential commercialization of the drug in 2025 and in that setting I am thrilled to welcome Phil tenant as the chief commercial officer for our company and we have been very excited that Phil has joined the leadership. And now currently leading all activities around the commercialization for Piagin 2012 and I would like to hand over actually to Phil to hear from him and his perspective on the commercial the path of Piagin 2012.

Phil Tenant: It is around the commercialization for <unk> 2012, and I would like to hand over actually to fill to hear from him on his perspective on the commercial part of <unk> 2012 fell Greg. Thank you Alan and thanks, everybody great to be here with you. This afternoon.

Phil Tennant: Great. Thank you, Helen. Thanks, everybody.

Phil Tennant: Great to be here with you this afternoon. Please let me take a few moments to make some introductory comments about myself and then some remarks about the commercialization efforts of the end 2012. So I'm now into my fourth decade in the industry, and a common theme for my experience across the industry has been launch activity. Experience of global launches in the UK, Europe, Japan, Australia, and now the US, and one of the common threads running through those launches has been the setting of new treatment paradigms and new standards of care, particularly in my most recent oncology experience. Many of those diseases have been red diseases; they've been areas with high unmet need and few, if any, treatment options for patients. And so I'm aware of the impact that successful treatments can have on patients, on families, and on the broader healthcare system.

Phil Tenant: Let me take a few moments to make some introductory comments about myself and then some remarks about the commercialization efforts.

Speaker Change: In 2012.

Phil Tenant: So I'm now into my fourth decade.

Phil Tenant: The industry.

Phil Tennant: Great. Thank you Helen. Thanks everybody. Great to be here with you this afternoon. Please let me take a few moments to make some introductory comments about myself and then some remarks about the commercialization efforts of the end 2012. So I'm now into my fourth decade in the industry and common theme for my experience across the industry has been launch activity. Experience of global launches launches in the UK Europe Japan Australia and now the US and one of the common threads running through those launches has been the setting of new treatment paradigms and new standards of care particularly in my most recent oncology experience and many of those diseases have been red diseases they've been areas with high and met need and few if any treatment options for patients and so I'm aware of the impact that successful treatments can have on patients on families and on the broader healthcare system.

Greg: And the common theme for my experience across the industry as being launch activity.

Greg: Experience of global launches launches in the U K, Europe, Japan, Australia, and now with the U S and <unk>.

Greg: One of the common thread running through those launches has been in the setting of new treatment paradigms and new standards of care, particularly in my most recent oncology experience and many of those diseases have be rare diseases, they've been areas with high unmet need.

Greg: And few if any treatment options for patients and so I'm aware of the impact that successful treatments can have on patients on families and on the broader health care system and.

Phil Tennant: And so PRGN 2012 absolutely fits into that category, which is why I'm excited to be here and I'm excited for the potential for launch. Helen, I think, did a great job in summarizing the compelling clinical offering this drug has: you know, the reduction in the complete response rate of over 50%, the 86% of patients who see a reduction in surgeries. And we've actually heard from patients that the reduction of a single surgery is extremely meaningful. So, we appear to have a very effective treatment, well tolerated, and it could reduce the burden on patients and the healthcare system quite considerably.

Greg: So <unk> 2012, absolutely fits into that category, which is why I'm excited to be here and I'm excited for the potential for launch.

Alan: Alan I think they did a great job in summarizing the compelling clinical.

Speaker Change: Uh huh.

Alan: The offering.

Alan: The drug has.

Phil Tennant: And so PRGN 2012 absolutely fits into that category which is why I'm excited to be here and I'm excited for the potential for launch. Helen, I think, did a great job in summarizing the compelling clinical offering this drug has, you know, the reduction in the complete response rate of over 50%, the 86% of patients who see a reduction in surgeries. And we've actually heard from patients that the reduction of a single surgery is extremely meaningful.

Speaker Change: The reduction in the complete response rate of over 50% the 86% of patients who see a reduction in surgeries and we've actually heard from patients that the reduction of a single surgery is extremely meaningful. So we appear to have a very effective treatment well tolerated and it could reduce the burden.

Speaker Change: On patients and the health care system quite considerably.

Phil Tennant: The commercial team today has been laying a lot of the groundwork for market access for distribution. And with now, with me coming on board, we're beginning to really ramp up our full commercial launch preparation activities across marketing, sales, thought leader engagement, congress activity, publications, and so on.

Speaker Change: Our commercial team to date has been laying a lot of the groundwork for market access for distribution.

Phil Tennant: So, we appear to have a very effective treatment, well tolerated, and it could reduce the burden on patients and the healthcare system quite considerably. The commercial team today has been laying a lot of the groundwork for market access for distribution. And with now, with me coming on board, we're beginning to really ramp up our full commercial launch preparation activities across marketing sales, thought leader engagement, congress activity, publications, and so on. So it is a very exciting time for the organization in a great moment for me to join.

Speaker Change: Now with me coming on board, where we're beginning to really ramp up our full commercial launch preparation activities across marketing sales thought leader engagement Congress activity publications and so on so it is a very exciting time for the organization and a great moment for me to to.

Phil Tennant: So it is a very exciting time for the organization in a great moment for me to join. In terms of timelines, many of the commercial timelines are, of course, derived from the BLA submission timing. And so that's a very important milestone for us. There is a lot to do, and hopefully a relatively short space of time so that we can bring this treatment to patients in 2025. And in thinking about our commercial buildout, it is a rare disease, so the Salesforce footprint will need to be precise. But just as importantly, we need to think in parallel about our medical affairs organization, particularly the customer-facing component of the medical affairs team, so that we can deliver an integrated and seamless experience to our patients and our customers.

Speaker Change: To join.

Speaker Change: In terms of timelines many of the commercial timelines are of course derived from the BLA submission timing and so that's a very important milestone for US there is a lot to do and hopefully a relatively short space of time. So that we can bring this treatment to patients in 2025.

Phil Tennant: In terms of timelines, many of the commercial timelines are of course derived from the BLA submission timing. And so that's a very important milestone for us. There is a lot to do and hopefully a relatively short space of time so that we can bring this treatment to patients in 2025. And in thinking about our commercial buildout, it is a rare disease, so the Salesforce footprint will need to be precise. But just as importantly, we need to think in parallel about our medical affairs organization, particularly the customer facing component of the medical affairs team so that we can deliver an integrated and seamless experience to our patients and our customers.

Speaker Change: And then thinking of our commercial build out it is a rare disease. So the sales force footprint will need to be precise, but just as importantly, we need to think in parallel about our medical affairs organization, particularly the customer facing components of the medical affairs team. So that we can deliver an integrated and seamless experience to our pace.

Speaker Change: <unk> and our customers.

Phil Tennant: And we look forward to making significant progress here during the remainder of this year and into 2025. So we continue to believe that this indication represents a significant market opportunity based upon the very higher met need, the safety and efficacy results that we've seen, and the prescribed preference in our market research.

Speaker Change: Look forward to making significant progress here during the remainder of this year and into 2025.

Speaker Change: So we continue to believe this indication represents a significant market opportunity based upon the very high unmet need for safety and efficacy results that we've seen and the prescriber preference and our market research So without island and back to you. Thank you very much felt.

Phil Tennant: And we look forward to making significant progress here during the remainder of this year and into 2025. So we continue to believe that this indication represents a significant market opportunity based upon the very higher met need, the safety and efficacy results that we've seen and the prescribed preference in our market research.

Helen Sabzevari: So, with that, Ellen, a hand back to you. Thank you very much.

Helen Sabzevari: Well, so what I would like to do in this part of the talk is really focus on our strategic prioritization. As a result of prioritizing 2012 for all the reasons that we mentioned and we are excited about for a potential commercial launch, last week we announced a series of strategic initiatives.

Speaker Change: So what I would like to do in this part of the talk is really focus on our strategic prioritization.

As a result of prioritizing 2012 for all the reasons that we mentioned and we are excited about for the potential commercial launch of last week, we announced a series of strategic initiatives.

Helen Sabzevari: So with that, Ellen, a hand back to you. Thank you very much.

Helen Sabzevari: Well, so what I would like to do in this part of the talk is a really focus on our strategic prioritization. As a result of prioritizing 2012 for all the reasons that we mentioned and we are excited about for a potential commercial launch, a last week we announced a series of strategic initiatives. Before I go and explain it, first of all, I would like to thank Chief Operating Officer, Rutul Shah, who's here today with us for not only all the tireless work that he has done over the years for the buildup of this organization, but also especially the important role that he has played in really at this point for this strategic prioritization.

Helen Sabzevari: Before I go and explain it, first of all, I would like to thank Chief Operating Officer, Rutul Shah, who's here today with us for not only all the tireless work that he has done over the years for the buildup of this organization, but also especially the important role that he has played in really, at this point, for this strategic prioritization. And some of the, especially the operational aspects that we had to change and rapidly focus on our PRG in 2012. So I really thank Rutul for all of the hard work.

Speaker Change: Before I go unexplained it first of all I would like to tank.

Speaker Change: <unk>.

Richard Shaw: Chief Operating officer, Richard Shaw, who is here to stay with us for not only all the tireless work that he has done over the years for the.

Speaker Change: Buildup of this organization, but also especially the important role that he has played and really at this point for this strategic prioritization and some of the especially the operational aspects that we had to change and rapidly fall.

Speaker Change: Based on our <unk> 2012, so I really tanker tool for all of the hard work.

Helen Sabzevari: Let's start by pointing out that, as part of this strategic prioritization, we had to make the difficult decisions to implement a reduction of over 20% of our. Workforce, which is always extremely difficult. However, in this set, we have to redirect resources to our PRG in 2012. In the clinic, we have implemented also various cost-saving measures as well. For instance, our PRG in 2009, which is the treatment in a recurrent, metastatic cervical cancer, as well as in head and neck related, HPV related cancers. We have focused the trials to our cradle at NCI NIH. And the PRG in 2009, it continues to advance through our cradle partnership with the National Cancer Institute.

Speaker Change: Let's start by pointing out that as part of these strategic prioritization, we have made the difficult decisions to implement a reduction of over 20% of our workforce, which is always extremely difficult. However in this sense, we have to re direct resources.

Helen Sabzevari: And some of the, especially the operational aspects that we had to change and rapidly focus on our PRG in 2012. So I really thank Rutul for all of the hard work. Let's start by pointing out that as part of this strategic prioritization, we had to make the difficult decisions to implement a reduction of over 20% of our. Workforce, which is always extremely difficult. However, in this set, we have to redirect resources to our PRG in 2012.

Speaker Change: <unk> 2012 in.

Speaker Change: In the clinic, we have implemented also various cost saving measures as well.

Speaker Change: For instance.

Speaker Change: For <unk> 2009, which is the treatment in a recurrent metastatic <unk>.

Speaker Change: Cervical cancer as well as in head and neck.

Helen Sabzevari: In the clinic, we have implemented also various cost saving measures as well. For instance, our PRG in 2009, which is the treatment in a recurrent, metastatic cervical cancer, as well as in head and neck related, HPV related cancers. We have focused the trials to our cradle at NCI NIH. And the PRG in 2009, it continues to advance through our cradle partnership with National Cancer Institute. In regard to our ultra-cartie, as you are aware, we had two, three clinical programs.

Speaker Change: Relay that H.

Speaker Change: HPV related cancers, we have focused the trials too.

Speaker Change: Two our credo at NCI NIH and the <unk> 2009, it continues to advance through our credo, our partnership with National Cancer Institute.

Helen Sabzevari: In regard to our ultra-cartie, as you are aware, we had two, three clinical programs. And what we have done is we have announced the complete enrollment of PRG in 2006, which is our ultra-cartie and acute myeloid leukemia, AML patients. Last year, we had reported on our phase one data of the AML patients that they were treated with our PRG in 2006. And if you recall, these are patients that they have failed a number of treatments that, unfortunately, have very few months to live. And it was very exciting that we had reported more than 27% objective responses in a very, very challenging patient population with our PRG in 2006.

Speaker Change: In regard to our ultra car T.

Speaker Change: You are aware, we had 228 and three clinical programs.

Speaker Change: And what we have done is we have announced the complete enrollment of <unk> 3006, which is our ultra protein acute myeloid leukemia AML patients.

Helen Sabzevari: And what we have done is we have announced the complete enrollment of PRG in 2006, which is our ultra-cartie and acute myeloid leukemia, AML patients. Last year, we had reported on our phase one data of the AML patients that they were treated with our PRG in 2006. And if you recall, these are patients that they have failed number of treatments that unfortunately have very few months to live. And it was very exciting that we had reported more than 27% objective responses in a very, very challenging patient population with our PRG in 2006.

Speaker Change: Last year, we had reported it on our phase one data of the AML patients that they would treat met three does with our PR. Gen 3600, if you recall these are patients that.

Speaker Change: They have failed number of treatments that unfortunately have very few months.

Helen Sabzevari: Our patients had both complete responses as well as partial responses. And by the way, our PRG in 2006 has received a fast track designation from the FDA. So I'm excited to announce that we have finished the phase one B of this. And we are preparing to move forward for discussions with the FDA in regard to the strategies for next steps. In regard to our PRG in 2005, in a way, in cancer and 2007, our role one card at the trials in order to minimize the spend, we have paused these trials currently. We are also looking at continuing to focus on a strategic partnership to further advance our ultra-cartie platform. In addition, we also have all pre-clinical programs across the company at this moment.

Speaker Change: Two left and it was very exciting that we had reported 20 more.

Speaker Change: More than 27% objective responses.

Speaker Change: Very very challenging patient population with our.

Speaker Change: <unk> 3006 <unk>.

Helen Sabzevari: Our patients had both complete responses as well as partial responses. And by the way, our PRG in 2006 has received a Fast Track designation from the FDA.

Our patients had both complete responses as far as well as partial responses.

Speaker Change: And.

Speaker Change: By the way our <unk> 3006 has received fast track designation from the FDA. So.

Helen Sabzevari: So I'm excited to announce that we have finished the Phase One B of this. And we are preparing to move forward for discussions with the FDA in regard to the strategies for next steps.

Speaker Change: I'm excited to announce that we have finished.

Speaker Change: The phase one b of this and we are preparing to move forward.

Speaker Change: Discussions with the SBA in regard to their strategies for next steps in regard to our PR Gen 3005 in ovarian cancer and 3007 odd roller one part and the trials in order to minimize the spend we have paused these trials Colorado.

Helen Sabzevari: In regard to our PRG in 2005, in a way, in cancer and 2007, our role one card at the trials in order to minimize the spend, we have paused these trials currently. We are also looking at continuing to focus on a strategic partnership to further advance our ultra-cartie platform. In addition, we also have all pre-clinical programs across the company at this moment.

Speaker Change: Play.

Speaker Change: They are also looking at continuing to focus on their strategic partnership.

Speaker Change: To further advance our ultra car T platform.

Speaker Change: In addition, we also have all paused all of our preclinical programs across the company at this moment.

Speaker Change: Okay.

Helen Sabzevari: Finally, we also have initiated a shutdown in active bio. It's our bell jump-based subsidiary. The portfolio and IEP remain available for prospective transaction, of course. As we move on. As I mentioned, with that, what we have done is really try to focus our resources on the highest priority asset, which is our PRGN 2012, and prepare for the potential launch. Now we're having filled by our side that we are excited to prepare for the potential launch. Globally for this drug.

Speaker Change: Finally, we also have initiated a shutdown in active buyer, it's our Belgium based subsidiary their portfolio and IP remain available for prospective transaction of course.

Speaker Change: As we move on.

Speaker Change: As I mentioned with that what we have done is really try to focus our.

Helen Sabzevari: Finally, we also have initiated a shutdown in active bio. It's our bell jump-based subsidiary. The portfolio and IEP remain available for prospective transaction, of course, as we move on. As I mentioned, with that, what we have done is really try to focus our resources on the highest priority asset, which is our PRGN 2012, and prepare for the potential launch and now we're having filled by our side that we are excited to prepare for the potential launch. Globally for this drug.

Speaker Change: Resources on the highest priority asset, which is our <unk> 2012 and <unk>.

Speaker Change: Prepare for the potential launch and now with having fell.

Speaker Change: By our side and debt.

Speaker Change: We are excited to prepare for a potential launch globally.

Speaker Change: For this drug so with that.

Harry Thomasian: So, with that, I will now turn the call over to Harry for the financial update. Harry. Thank you, Helen, and good afternoon to all of those on the call today. As Helen mentioned earlier, it is a pivotal time for Precigen with our recently announced asset prioritization and what could be the first FDA-approved treatment for our patients in the near future.

Speaker Change: I will now turn the call over to Sallie for the financial update Terry. Thank you Helen and good afternoon to all of those on the call today.

Sallie: As Helen mentioned earlier it is a pivotal time for precedent with our recently announced asset prioritization in what could be the first FDA approved treatment for RP patients in the near future.

Harry Thomasian: So with that, I will now turn the call over to Harry for the financial update, Harry. Thank you, Helen, and good afternoon to all of those on the call today. As Helen mentioned earlier, it is a pivotal time for Precigen with our recently announced asset prioritization and what could be the first FDA approved treatment for our patients in the near future.

Harry Thomasian: Before I talk about the company finances, I also want to publicly welcome Phil Tennant to the Precigen team. We're excited about the value that Phil has brought to the table in the short time that he's been with Precigen, and I look forward to working with him as we prepare for the anticipated commercial launch of PRGN 2012. I want to first touch on our recently announced prioritization of assets and the successful issuance equity issuance that we completed last week. Based on the prioritization of assets, which will result in streamlining of operations, the company expects to significantly reduce future operating costs.

Sallie: Before I talk about the company's finances I also want to publicly welcome Phil tenants to the precedent team. We're excited about the value that Phil has brought to the table in the short time that he's been with precedent and I look forward to working with him as we prepare for the anticipated commercial launch of <unk> in 2012.

Harry Thomasian: Before I talk about the company finances, I also want to publicly welcome Phil Tennant to the Precigen team. We're excited about the value that Phil has brought to the table in the short time that he's been with Precigen, and I look forward to working with him as we prepare for the anticipated commercial launch of PRGN 2012.

Sallie: I want to first touch on our recently announced prioritization of assets and the successful issuance equity issuance that we completed last week base.

Sallie: Based on the prioritization of assets, which will result in streamlining of operations the company expects to significantly reduce future operating costs.

Harry Thomasian: I want to first touch on our recently announced prioritization of assets and the successful issuance equity issuance that we completed last week. Based on the prioritization of assets, which will result in streamlining of operations, the company expects to significantly reduce future operating costs. Last week's equity issuance netting $31.4 million plus our cash and investments on hand, which totaled $19.5 million at June 30th, will provide a runway into early 2025. I've had many investors ask the question as to why we did not raise more than the $31.4 million.

Harry Thomasian: Last week's equity issuance netting $31.4 million, plus our cash and investments on hand, which totaled $19.5 million at June 30th, will provide a runway into early 2025. I've had many investors ask the question as to why we did not raise more than the $31.4 million. The short answer is that our opinion is that the company is fundamentally undervalued. In addition, the Procede received last week allows us to focus on the advancement of PRGN 2012 in the near term, while providing us the time to consider various financing options, inclusive of non-dilutive options. Our focus has and always will be to utilize our resources, the garner the highest value for our shareholders.

Sallie: Weeks equity issuance, netting 31 $4 million, plus our cash and investments on hand, which totaled $19 $5 million at June 30, we will provide a runway into early 2025.

Sallie: I've said many investors asked the question as to why we did not raise more than the $31 $4 million. The short answer is that our it is our opinion that the company is fundamental mentally undervalued.

Sallie: In addition to proceeds received last week allows us to focus on the advancement of <unk> 2012 in the near term, while providing us the time to consider various financing options inclusive of non dilutive options. Our focus has and always will be to utilize our.

Harry Thomasian: The short answer is that our opinion that the company is fundamentally undervalued. In addition, the Procede received last week allows us to focus on the advancement of PRGN 2012 in the near term, while providing us the time to consider various financing options, inclusive of non-dilutive options. Our focus has and always will be to utilize our resources, the garner the highest value for our shareholders.

Sallie: Forces to garner the highest value for our shareholders.

Harry Thomasian: With that being said, from a high level Q2 financial results perspective, our net loss for the quarter ended June 30th was $58.8 million or $0.23 cents per share. Compared to a net loss of $20.3 million, our 8 cents a share in the period ended June 30th, 2023. It should be pointed out that the 2024 period net loss includes $32.8 million of non-cash impairment charges, net of attack benefit, specific to our active bio business. We filed our 10-Q as well as our quarterly press release on financial results and business update with the SEC just prior to this call.

Speaker Change: With that being said from a high level Q2 financial results perspective, our net loss for the quarter ended June 30 was $58 $8 million or 23 per share compared to a net loss of $20 3 million or eight cents a share in the period ended June 32023.

Harry Thomasian: With that being said, from a high level Q2 financial results perspective, our net loss for the quarter-ended June 30th was $58.8 million or $23 cents per share. Compared to a net loss of $20.3 million, our 8 cents a share in the period ended June 30th, 2023. It should be pointed out that the 2024 period net loss includes $32.8 million of non-cash, impairment charges, net of attack benefit, specific to our active bio business.

Sallie: <unk>.

Sallie: It should be pointed out that the 2024 period net loss includes $32 $8 million of noncash impairment charges net of tax benefit specific to our active buyer business.

Sallie: We filed our 10-Q as well as our quarterly press release on financial results and business update with the SEC just prior to this call you can find more detailed financial information in those documents.

Unknown Attendee: You can find more detailed financial information in those documents.

Unknown Attendee: With that said, I'd like to open the call up for Q&A, operator. Thank you. Ladies and gentlemen, we will now begin the question-and-answer session. If you have a question, please press the store, followed by the one on your touchstone phone. You will hear a prompt that your hand has been raised. Questions will be taken in the order received. If you do wish to cancel your request, please press the store, followed by the queue. If you are using a speaker phone, please leave the answer before posting any questions. Once again, that is star one should wish to ask a question.

Speaker Change: With that said I'd like to open the call up for Q&A operator.

Harry Thomasian: We filed our 10Q as well as our quarterly press release on financial results and business update with the SEC just prior to this call. You can find more detailed financial information in those documents.

Speaker Change: Yeah.

Thank you ladies and gentlemen, we will now begin the question and answer session.

Speaker Change: So do you have a question. Please press the star followed by one on you touched on filing.

Operator: With that said, I'd like to open the call up for Q&A, Operator. Thank you. Ladies and gentlemen, we will now begin the question and answer session. If you have a question, please press the store, follow by the one on your touchstone phone. You will hear a prompt that your hand has been raised. Questions will be taken in the order received. If you do wish to cancel your request, please press the store, followed by the queue. If you are using a speaker phone, please leave the answer before posting any questions. Once again, that is star one should wish to ask a question.

Speaker Change: You will hear a prompt take our hand has been raised questions will be taken in the order received.

Speaker Change: Should you wish to cancel no request. Please press the star followed by the <unk>.

Speaker Change: If you're using a speaker phone. Please go ahead cohorts at the Park Plaza.

Speaker Change: Once again that is star one should you wish to ask a question.

Carolina: Your first question is from Ben Burnett from Staple. Please ask a question.

Speaker Change: Your first question is from Ben Burnett from Stifel. Please ask one question.

Carolina: Hello, good afternoon. This is Carolina. I've been sent also on for Ben Burnett. Thank you for taking our question. To start with, recently a close competitor has announced it has delayed its DLA filing. What are the key factors for you to commence the rolling DLA submission of PRGN 2012? And this way, ensure you keep a living in IRB.

Scott arena: Hello. Good afternoon. This is Scott arena.

Ben Burnett: Then it goes on for Ben.

Ben Burnett: Thank you for taking a question.

Ben Burnett: So to start with.

Speaker Change: Recently, our close competitor has announced that it has delayed its BLA filing.

Carolina: Your first question is from Ben Burnett from staple. Please ask a question. Hello, good afternoon. This is Carolina. I've been sent also on for Ben Burnett. Thank you for taking our question. To start with, recently a close competitor has announced it has delayed its DLA filing. What are the key factors for you to commence the rolling DLA submission of PRGN 2012? And this way, ensure you keep a living in IRB. Hi, Carolina.

Speaker Change: What's the gating factor for you to commence the rolling BLA submission of <unk> in 2012.

Speaker Change: And these we ensure to keep on making in that RFP.

Okay.

Helen Sabzevari: Hi, Carolina. Thanks for the question. So, in regards to, obviously, we are laser focused on our submissions. And as we have guided before and continue to guide, we anticipate to submit our BLA by the end of 2024. And we are on track for that.

Carl: Hi, Carl or not and thank you for the question. So in regard to obviously, we are laser focused on our submissions.

Speaker Change: And as we have guided before and continue to guide.

Speaker Change: Anticipate to submit.

Speaker Change: L a.

Speaker Change: By the end of 2024, and we are on track for that I think we're as I mentioned, we are really excited about <unk> 2012, and the differentiation of this.

Carolina: Thanks for the question. So in regards to, obviously, we are laser focused on our submissions. And as we have guided before and continue to guide, we anticipate to submit our BLA by the end of 2024. And we are on track for that. I think with, as I mentioned, we are really excited about our PRGN 2012 and the differentiation of these gene therapy treatment for the ease of the treatment, which is a subcure injection and does not require any kind of devices and the complexity there as well as the obviously the safety, favourable safety and supported by really outstanding efficacy that we see as far as complete responses followed by also secondary endpoints of reduction in the number of surgeries.

Carolina: So with that, I would just guide that we continue to focus our efforts on our direct treatment and really positioning it for potential launch in 2025. Okay, understood. And then as a follow-up, given that PRGN 2012 represents a novel therapeutic modality for RRP, so you think you will get an outcome meeting and then what can you do to prepare for a case that is one? Thank you. So thank you. I think these are questions that obviously we cannot answer if there are outcome meetings.

Helen Sabzevari: I think with, as I mentioned, we are really excited about our PRGN 2012 and the differentiation of these gene therapy treatment for the ease of the treatment, which is a subcure injection and does not require any kind of devices and the complexity there, as well as the obviously the safety, favourable safety and supported by really outstanding efficacy that we see as far as complete responses followed by also secondary endpoints of reduction in the number of surgeries. So, with that, I would just guide that we continue to focus our efforts on our direct treatment and really positioning it for potential launch in 2025.

Speaker Change: Gene therapy treatment for the ease of the treatment, which is a sub Q injection and does not require any kind of devices and the complexity there as well as that obviously the safety of favorable safety and.

Speaker Change: And support that by really outstanding efficacy that we see as far as complete responses followed by also.

Speaker Change: Secondary endpoints of reduction in the number of factories, so with that I would just guide that we continue to focus our efforts on our drug treatments and really positioning it for the potential launch in 2025.

Unknown Attendee: Okay, understood.

Speaker Change: Okay understood and then as a follow up given that the <unk> 2012 represents a novel therapeutic modality for RFP do you think you will get on that mid teen.

Unknown Attendee: And then as a follow-up, given that PRGN 2012 represents a novel therapeutic modality for RRP, so you think you will get an outcome meeting, and then what can you do to prepare for a case that is one? Thank you. So thank you. I think these are questions that obviously we cannot answer if there are outcome meetings.

Speaker Change: Tim what can you do to prepare for phase one.

Speaker Change: Thank you Phil and thank.

Thank you.

Speaker Change: I think Oh geez.

Speaker Change: Pressures that.

Speaker Change: Obviously, we cannot answer if there are outcome meetings and in general the way I look at these things.

Helen Sabzevari: And in general, the way I look at these things, that is always FDA has that call to have outcome meetings, but in general, when you look at the diseases, the outcomes come at the times that there are perhaps there are questions in the consistency of the data or in the various, let's say, groups. And in this case, what I like to express is that if you look at our two pivotal data, the consistency is actually really important. in a phase one, which we recruited, which was 12 patients enrolled. We had a 50% complete responders. And basically, in phase two, we had 52% complete responders.

Speaker Change: That is always FDA has that call to have the AD comm meeting, but in general when you look at the diseases. The outcomes come at the times that there are perhaps.

Speaker Change: There are questions in the consistency of the data or and barriers.

Carolina: And in general, the way I look at these things, that is always FDA has that call to have outcome meetings, but in general, when you look at the diseases, the outcomes come at the times that there are perhaps there are questions in the consistency of the data or in the various, let's say, groups. And in this case, what I like to express is that if you look at our two pivotal data, it's the consistency is actually really important, in a phase one which we recruited, which was 12 patients enrolled.

Speaker Change: Let's say groups and in this case, what I like to.

Speaker Change: Express is that if you look at our two pivotal data.

Speaker Change: It's the consistency is actually really amazed.

Speaker Change: Phase, one, which we recruited ever which were 12 patients enrolled we had.

Speaker Change: Okay.

Speaker Change: Ft percent complete responders.

Speaker Change: And.

Speaker Change: Basically.

Speaker Change: In phase two.

Speaker Change: Had 52% complete responders.

Helen Sabzevari: So you cannot come any closer in clinical trial at this kind of data. And same thing, by the way, for our secondary endpoints and immunological responses.

Speaker Change: So you cannot come any closer in a clinical trial that this kind of data and the same thing by the way for our secondary endpoints and immunological responses. So the way I usually have answered. This question as comps are always at the discretion of SBA and.

Carolina: We had a 50% complete responders. And basically, in phase two, we had 52% complete responders. So you cannot come any closer in clinical trial at this kind of data. And same thing, by the way, for our secondary endpoints and immunological responses. So the way I usually answer this question, outcomes are always at the discretion of an FDA, and it's not according to the company. But also, we believe that our clinical data has met both primary and secondary endpoints completely. And I think the data is both for itself. I'd ask. Go ahead. I appreciate it. Bonjour.

Helen Sabzevari: So the way I usually answer this question, outcomes are always at the discretion of an FDA, and it's not according to the company. But also, we believe that our clinical data has met both primary and secondary endpoints completely. And I think the data is both for itself.

It's not according to the company.

Speaker Change: But also we believe that.

Speaker Change: And clinical data has met both primary and secondary endpoints completely.

Speaker Change: The data speak for itself.

Unknown Attendee: I'd ask.

Unknown Attendee: Go ahead. I appreciate it.

Speaker Change: Got it I appreciate it.

Speaker Change: Okay.

Jason Butler: Bonjour. Next question is from Jason. Both are from citizens.

Laura: Home Shield. Laura next question is from Jason Butler from citizens JMP. Please ask your question.

Jason Butler: Jay and Penny, please ask her question. Hi. Thanks for taking the questions. Just had one for Phil, kind of, as he joins the company.

Jason Butler: Hi, Thanks for taking the questions just had one for bill kind of.

Phil Tennant: I wonder if he could just give us his high-level thoughts on what attracted him to the opportunity, how he thinks about the opportunity in RRP, and what the priorities will be in the coming months as the BLA is submitted and reviewed by the FDA, and then I have a follow-up. Thanks.

Jason Butler: Joining the company I wondering if you could just give us.

Bill: High level thoughts on what attracted him to the opportunity.

Jason: Next question is from Jason. Both are from citizens. Jay and Penny, please ask her question. Hi. Thanks for taking the questions. Just had one for Phil, kind of, as he joins the company.

Bill: How he thinks about the opportunity in our ERP and what the priorities will be.

Speaker Change: The coming months as the B L.

La is submitted and reviewed by FDA and then I have a follow up thanks.

Phil Tennant: I wonder if he could just give us his high level thoughts on what attracted him to the opportunity, how he thinks about the opportunity in RRP, and what the priorities will be in the coming months as the BLA is submitted and reviewed by FDA, and then I have a follow-up. Thanks. Hi, Jason. Phil? Sure. Yeah, I think, thanks for the question. I think I alluded to that in some of my comments earlier.

Phil Tennant: Hi, Jason. Phil? Sure. Yeah, I think thanks for the question. I think I alluded to that in some of my comments earlier. Given my history, particularly in oncology, some of the rare diseases that I've worked in, the rare tumors, the higher met need, the lack of available treatment options for patients. I am aware of where therapies can have such a significant impact on patient populations, on caregivers, on the healthcare system. And so, this is one of those areas that I think fits into that category perfectly: a very high unmet need, nothing other than surgery and multiple surgeries at that for most patients, and it's crying out for therapeutic alternatives.

Speaker Change: Sure Hi, Jason itself sure Yeah, I think thanks for the question I think I alluded to that some of my my comments earlier, given my history, particularly in oncology some of the rare diseases that I've worked in the rare tumors the high unmet need.

Speaker Change: The lack of available treatment options for patients.

I am aware of where therapies can have such a significant impact on patient populations on caregivers on the health care system and so this is one of those areas that I think fits.

Phil Tennant: Given my history, particularly in oncology, some of the rare diseases that I've worked in the rare tumors, the higher met need, the lack of available treatment options for patients. I am aware of where therapies can have such a significant impact on patient populations, on care givers, on the healthcare system. And so, this is one of those areas that I think fits into that category perfectly, a very high on met need, nothing other than surgery and multiple surgeries at that for most patients, and it's crying out for therapeutic alternatives.

Speaker Change: Fits into that category perfectly.

Speaker Change: A very high unmet need nothing other than surgery and multiple surgeries at that for most patients.

Speaker Change: And it is crying out for therapeutic.

Speaker Change: Alternatives and so that's fundamentally the attractive nature of this disease for me, it's consistent with what sort of kept me going in my career to date.

Phil Tennant: And so, that's fundamentally the attractive nature of this disease for me. It's consistent with what sort of kept me going in my career to date, and it's an opportunity that I relish as we go forward.

Speaker Change: It's an opportunity that I relish as we as we go forward the priorities moving forward as you would expect tiny tiny is ticking so as I come on board, it's really about right sizing the opportunity and commensurate with that making sure our commercial footprint to now build is appropriate that we understand who the.

Phil Tennant: The priority is moving forward, as you would expect. You know, time is ticking. So, as I come on board, it's really about right sizing the opportunity, and then, commensurate with that, making sure our commercial footprint in our build is appropriate that we understand who the treating healthcare professional is. We understand the multidisciplinary approach to that, to the patient. We understand the patient journey, and we build our commercial and our medical affairs scenes accordingly, so that we can best support the patient, best support the customer, and make this as seamless as possible to get this new treatment to those patients who are obviously in need of it.

Phil Tennant: And so, that's fundamentally the attractive nature of this disease for me. It's consistent with what sort of kept me going in my career to date, and it's an opportunity that I relish as we go forward. The priority is moving forward, as you would expect, you know, time is ticking. So, as I come on board, it's really about right sizing the opportunity, and then commensurate with that, making sure our commercial footprint in our build is appropriate that we understand who the treating healthcare professional is.

Speaker Change: The treating.

Speaker Change: Healthcare professionally as we understand the multidisciplinary approach to that to the patients we understand the patient journey and we build our commercial and medical affairs teams. Accordingly, so that we can best support the patient support the customer and make this as seamless as possible to get this new treatment to.

Phil Tennant: We understand the multidisciplinary approach to that, to the patient. We understand the patient journey, and we build our commercial and our medical affairs scenes accordingly, so that we can best support the patient, best support the customer, and make this as seamless as possible to get this new treatment to those patients who are obviously are in need of it.

Speaker Change: To those patients who obviously are in need of it.

Jason: Great. Thank you.

Speaker Change: Okay.

Unknown Attendee: Great. Thank you.

Speaker Change: Great helpful. Thank you and then and then Helen can you.

Helen Sabzevari: And then, Helen, can you just talk about, in terms of the strategic prioritization, how we should think about the ultra-party programs? I guess it's a two-part question here. One, for PRGN in 2006, will we get a clinical update or an update on the clinical data this year? And how are you thinking about, or what is the interest level or prioritization already been on looking for partners for these programs? Yeah. No.

Helen: You just talked about in terms of the strategic prioritization, how we should think about the ultra car T programs I guess two part question here one four <unk> 3006 will we get a clinical update or an update on the clinical data this year and how you're thinking about or what is the interest level.

Helen Sabzevari: And then, Helen, can you just talk about in terms of the strategic prioritization, how we should think about the ultra-party programs. I guess two part question here. One, for PRGN in 2006, will we get a clinical update or an update on the clinical data this year? And how are you thinking about, or what is the interest level or prioritization already been on looking for partners for these programs? Yeah. No. And thank you, Jason, for the question.

Speaker Change: <unk> or prioritization already banned all looking for partners for these programs.

Speaker Change: Yes no.

Helen Sabzevari: And thank you, Jason, for the question. So in regard to our ultra-cost, first of all, I have to mention, we are extremely still very excited about this platform. As I have mentioned, and I will continue to say that this is currently the only platform that it can deliver autologous clarity overnight in a setting of the hospital to the patient with substantially less cause. And not only doing that, the manufacturing is really it's the paradigm shifting and with have been treated no more than 70 patients, that it speaks to the ability to do this at the hospital and treat the patients.

Speaker Change: Thank you Jason for the question so in regard to our.

Speaker Change: Ultra car first of all I have to mention we are extremely.

Speaker Change: It's still a very excited about this platform as I have mentioned and I will continue to say that this is currently the only platform that can deliver autologous car T overnight in the setting of the hospital to the patient or waived as substantially.

Helen Sabzevari: So in regard to our ultra-cost, first of all, I have to mention, we are extremely still very excited about this platform. As I have mentioned, and I will continue to say that this is currently the only platform, that it can deliver autologous clarity overnight in a setting of the hospital to the patient with substantially less cause. And not only doing that, the manufacturing is really it's the paradigm shifting and with have been treated no more than 70 patients, that it speaks to the ability to do this at the hospital and treat the patients.

Speaker Change: They laugh at cars.

And not only doing that the manufacturing is really is the paradigm shifting and we have been through that now more than 70 patients.

Speaker Change: That speaks.

Speaks to the ability to do this at the hospitals and treat the patients and not only from a perspective of the safety, which has shown a very favorable safety, but also.

Helen Sabzevari: And not only from a perspective of the safety, which has shown a very favorable safety, but also directly manufacturing these autocarties in the patients, and also seeing objective responses.

Speaker Change: Directly manufacturing these are ultra car Ts in our patients.

Speaker Change: And also seeing objective responses.

Helen Sabzevari: So the reason for what we have done as far as pausing some of the two trials they were going, obviously, has been really focusing on PRG in 2012 and are basically commercial preparedness for potential launch for 2012 next year. And that doesn't mean that we the value of our ultra-cartie platform is any less than before or excitement about that. However, we have to take the tough decisions and give the priorities to what requires the priority at this moment. However, what we have done, and I'm very proud of our clinical team, is that we have finished actually our phase one B in our most advanced PRG in 2006.

Speaker Change: Are we.

Helen Sabzevari: And not only from a perspective of the safety, which has shown a very favorable safety, but also directly manufacturing these autocarties in the patients, and also seeing objective responses. So the reason for what we have done as far as pausing some of the two trials they were going, obviously, has been really focusing on PRG in 2012 and are basically commercial preparedness for potential launch for 2012 next year. And that doesn't mean that we the value of our ultra-cartie platform is any less than before or excitement about that.

Speaker Change: The reason for what we have done as far as pausing some of the two trials they've been growing obviously.

Speaker Change: Has been really focusing on <unk> 2012.

Basically commercial preparedness.

Speaker Change: For a potential launch for <unk> two in two.

Speaker Change: 2012 and next year.

And that doesn't mean that.

Speaker Change: The value of our ultra car T platform is any less than before to our excitement about that.

Speaker Change: However, we had to take the tough decision and gives us a RFP as to what requires the priority at this moment. However, what we have done and I'm very proud of our clinical team.

Speaker Change: Yes that we have finished our actually our phase one b and our most advanced.

Helen Sabzevari: However, we have to take the tough decisions and give the priorities to what requires the priority at this moment. However, what we have done, and I'm very proud of our clinical team, is that we have finished actually our phase one B in our most advanced PRG in 2006. Basic in AML indication. And we will be in as we move forward and we will communicate about the data and the guidance on showing the data.

Speaker Change: <unk> 3006.

Speaker Change: Hum.

Helen Sabzevari: Basic in AML indication. And we will be in as we move forward, and we will communicate about the data and the guidance on showing the data. However, what we are currently doing, as you know, we had received the Fast Track designation, which is very important, especially in this setting when interactions with FDA. So we're going to use that and prepare for a Phase One B meeting and then discuss the regulatory strategy for advancement of this in the upcoming months to next to 2025. So we are excited about that, and we will continue with those activities. But at the meantime, since we have been in the process, we are going to be able to make sure that we are able to make sure that we are the involvement of the patients for their phase 1B. Obviously, we are not occurring the clinical costs that is related to this asset.

Speaker Change: Basically in the AML indication and we will be in that as we move forward then we will communicate about the data.

Speaker Change: Guidance on showing the data.

Speaker Change: What we are currently doing as you know we have received a fast track designation, which is a very important especially in this setting with interactions with the FDA. So we are going to use that and prepare for a phase one b meeting and then discuss the Reg.

Helen Sabzevari: However, what we are currently doing, as you know, we had received the fast track designation, which is a very important, especially in this setting when interactions with FDA. So we're going to use that and prepare for a phase one B meeting and then discuss the regulatory strategy for advancement of this in the upcoming months to next to 2025. So we are excited about that and we will continue with those activity, but at the meantime since we[inaudible] The involvement of the patients for their phase 1B, obviously we are not occurring the clinical costs that is related to this asset. And that, again, further helps to put that resources on 2012.

Speaker Change: Our regulatory strategy for the advancement of this in the upcoming months to next to 2025. So we are excited about that and we will continue with dose activity, but at the meantime, since we have finished.

Speaker Change: Enrollment of the patients.

Speaker Change: The phase I B.

Speaker Change: Lastly, we are not occurring that clinical cost that is related to.

Speaker Change: To this asset and that again further helps to put our resources to our need to us.

Helen Sabzevari: And that, again, further helps to put that resources on 2012.

Unknown Attendee: Great, thanks for taking a question. Sure, thank you, Jason. Thank you.

Speaker Change: Great. Thanks for taking the questions.

Jason Butler: Thank you Jason.

Speaker Change: Thank you once again, please press star one should you wish to ask a question.

Swayamp Ramakanth: Once again, please press star 1 to do wish to ask a question. Your next question is from Swayamp Ramakanth, from H.C. Wade Wright. Is that your question? Thank you.

<unk> Rama: Your next question is from <unk> Rama from H C Wainwright.

Speaker Change: Ask your question.

Unknown Attendee: Great, thanks for taking a question. Sure, thank you, Jason. Thank you. Once again, please press star 1 to do wish to ask a question.

<unk> Rama: Sure.

RK: Thank you this is RK.

<unk> Rama: Afternoon.

Speaker Change: It's true.

<unk> Rama: Team.

<unk> Rama: So on the total.

Swayamp Ramakanth: This is our 2012 program. You know, would we see any additional data at all until you start talking about the confirmatory study? I have a couple more questions after that. Sure. Hi, okay. Thank you for the question. So we have shown their both Phase 1 and Phase 2 data, especially at ASCO. All the data was presented, including the safety, as well as the efficacy, tolerability, and durability. And they mean a logical response. So, as I mentioned, we have met the requirement and actually exceeded the requirement for meeting the endpoints of the phase 1 and phase 2.

Speaker Change: On the 2012 program.

Swayamp Ramakanth: Your next question is from Swayamp Ramakanth, from H.C. Wade Wright. Is that your question?

Speaker Change: Yeah.

Speaker Change: <unk>.

Speaker Change: Would we see any additional data at all.

Speaker Change: Until you.

Speaker Change: You start talking about the control study.

Speaker Change: And I have a couple more questions after that.

Helen Sabzevari: Thank you. This is our 2012 program. You know, would we see any additional data at all until you start talking about the confirmatory study, and I have a couple more questions after that. Sure. Hi, okay. Thank you for the question. So we have shown their both phase 1 and phase 2 data, especially at ASCO. All the data was presented, including the safety, as well as the efficacy, tolerability, and durability. And they mean a logical response.

RK: Hi, RK. Thank you for the question.

Speaker Change: We have shown.

Speaker Change: They're both phase one and phase two.

Speaker Change: Data, especially at.

Speaker Change: And <unk> and all the data was presented including the safety as well as the efficacy tolerability and durability and immunological responses. So.

And as I mentioned, we have met the requirement and actually exceeded the requirement.

Four.

Speaker Change: Is it for them.

Speaker Change: Meeting the endpoints of the boat.

Speaker Change: London Phase III.

Helen Sabzevari: We are currently, obviously, as I have mentioned, we are preparing for VLA submissions and rolling VLA by the end of this year. So there would be no further data, because the data is what FDA had asked us from phase 1 and phase 2, and that has been completed. Of course, one of the things that is ongoing with our patients is the durability of response, and those patients that they have participated in a phase 1 and phase 2, they continue to be followed by their physicians as they move on, and that data will be followed. And, of course, reported accordingly at times.

Speaker Change: We are currently obviously as I have mentioned we are preparing for.

Helen Sabzevari: So, as I mentioned, we have met the requirement and actually exceeded the requirement for the meeting the endpoints of the phase 1 and phase 2. We are currently obviously, as I have mentioned, we are preparing for VLA submissions and rolling VLA by the end of this year. So there would be no further data, because the data is what FDA had asked us from phase 1 and phase 2, and that has been completed.

Speaker Change: BLA submissions and.

Rolling BLA.

Speaker Change: By the end of this year. So there would be no further data because the data is what the FDA had asked us from phase, one and phase two and that.

Speaker Change: That has been completed of course.

Speaker Change: One of the things that is ongoing with our patients.

Speaker Change: Is there a durability of response in those patients that they have participated in our phase one and phase two they continue to be followed by their physicians as they move on and that data will be followed of course reported accordingly at times.

Helen Sabzevari: Of course, one of the things that is ongoing with our patients is the durability of response, and those patients that they have participated in a phase 1 and phase 2, they continue to be followed by their physicians, as they move on, and that data will be followed. And of course, reported accordingly at times. Okay. And then in terms of applications to regulatory authorities, is there any? Are you folks discussing potential submission in Europe for the same indication?

Helen Sabzevari: Okay. And then, in terms of applications to regulatory authorities, is there any? Are you folks discussing potential submission in Europe for the same indication? Yeah, excellent question. So, as I mentioned, we had already engaged there with EU authorities and XUS, as we not only received the orphan drug designation, but we have obviously initiated our efforts globally.

Speaker Change: Okay and then.

Sure.

Speaker Change: Applications to regulatory authorities is there any.

Speaker Change: Alright.

Speaker Change: Are you forced to discussing.

Speaker Change: Potential.

Speaker Change: Submission.

Speaker Change: In Europe.

Speaker Change: For the same indication.

Speaker Change: Yeah.

Speaker Change: Excellent question. So as I mentioned, we had already engaged there with the EU authorities in ex U S.

Speaker Change: We not only received orphan drug designation, but we have obviously initiated our efforts globally I don't go to the all the details for strategic reasons, but we are very excited about the potential of <unk> 2012 and ex U.

Helen Sabzevari: Yeah, excellent question. So, as I mentioned, we had already engaged there with EU authorities and XUS, as we not only received the orphan drug designation, but we have obviously initiated our efforts globally. I don't go to all the details for the strategic reasons, but we are very excited about the potential of PRGN 2012 in XUS in Europe. And as I mentioned, our facility commercial facilities, they have started their manufacturing. We have every confidence that by 2025, we will be in the position to provide the drug globally, but from for US, as well as XUS. So, we are excited about that and we look forward to that.

Phil Tennant: I don't go to all the details for the strategic reasons, but we are very excited about the potential of PRGN 2012 in XUS in Europe. And, as I mentioned, our facility commercial facilities, they have started their manufacturing. We have every confidence that by 2025, we will be in the position to provide the drug globally, but from the US, as well as XUS. So, we are excited about that, and we look forward to that. And I leave it at that.

Speaker Change: In the Europe, and as I mentioned, our facility commercial facility as they have started.

Speaker Change: And then manufacturing.

Speaker Change: We have every confidence that.

Speaker Change: By 2025, we will be in the position.

Speaker Change: To provide the drug globally.

Speaker Change: But for the U S as well as ex U S. So we are excited about that.

Speaker Change: We look forward to that and I'll leave it at that.

Swayamp Ramakanth: Okay, and the one last question.

Speaker Change: Okay and then one last question this is for Phil.

Phil Tennant: This is for Phil since this is a rare indication. What sort of, you know, what size of a commercial team do you need to set up before you get into the market? Yeah, that's a great question. You know, as I mentioned it because it is a rare disease. We have to be precise in our thinking. The footprint doesn't need to be, you know, we're not talking hundreds. Of sales team, for instance, we're talking tens, but the important thing that I would stress is that we've combined that without thinking on medical affairs, so we have a joined up approach from an internal perspective to our external environment.

Phil Tenant: Since this is.

Early indication what sort of.

Phil Tenant: What size of a commercial team do you need to set up before you get into the market.

Phil Tennant: And I leave it at that. Okay, and the one last question. This is for Phil since this is a rare indication. What sort of, you know, what size of a commercial team do you need to set up before you get into the market? Yeah, that's a great question. You know, as I mentioned it because it is a rare disease. We have to be precise in our thinking the footprint doesn't need to be, you know, we're not talking hundreds.

Phil Tenant: Yeah, that's a great question.

Phil Tenant: As I mentioned it because it is a rare disease, we have to be precise in our thinking the footprint doesn't need to be.

Phil Tennant: Of sales team, for instance, we're talking tens, but the important thing that I would stress is that we've combined that without thinking on medical affairs, so we have a joined up approach from an internal perspective to our external environment. So it's going to be a small but perfectly formed team, hopefully, particularly in terms of the customer facing aspect. Perfect. Thank you. Thanks for taking on the questions.

Phil Tenant: We're not talking hundreds of sales team for instance, we're talking tens.

Speaker Change: But the important thing that I would stress is that we combine that with our thinking on medical affairs. So we have a joined up approach from an internal perspective to our external environment. So it's going to be a small but perfectly formed team hopefully, particularly in terms of the customer facing aspect.

Unknown Attendee: Thank you. One's here.

Phil Tennant: So it's going to be a small but perfectly formed team, hopefully, particularly in terms of the customer-facing aspect. Perfect.

Perfect. Thank you thanks for taking all my questions.

Unknown Attendee: Thank you.

Sean: Thanks for taking on the questions. Thank you. One's here. Your next question is from Brian Chang from JP Morgan. Please ask the question. Thanks for taking our questions this afternoon. This is Sean on for Brian.

Speaker Change: Thank you.

Speaker Change: Thank you. Your next question is from Brian Cheng from Jpmorgan. Please ask your question.

Sean: Alright, Thanks for taking our question. This afternoon. This is Sean on for Brian could you remind us what the bar for response, you have to senior confirmatory trial is and.

Sean: Could you remind us what the bar for response you have to see in your confirmatory trial is? And based on your conversations with the agency, do you need to complete enrollment in this confirmatory trial before you receive the approval? Yeah, very good question. Thank you, Sean. So the bars for the confirmatory trial is similar to what we had for phase one and phase two. The design is also exactly the same. As we have mentioned, we do not have to; it's a single on and no randomization, no placebo control required, which, as you can imagine, that can be quite challenging enrollment to the placebo or randomizing these trials phase three trials.

Sean: Your next question is from Brian Chang from JP Morgan. Please ask the question. Thanks for taking our questions this afternoon. This is Sean on for Brian. Could you remind us what the bar for response you have to see in your conformatory trial is? And based on your conversations with the agency, do you need to complete enrollment in this conformatory trial before you receive the approval? Yeah, very good question. Thank you Sean.

Speaker Change: Based on your conversations with the agency do you need to complete enrollment in this confirmatory trial before you receive the approval.

Speaker Change: So a very good question. Thank you Sean.

Speaker Change: Theyre Barspoon confirmatory trial is similar to what we had for phase one and phase two design Asics also exactly the same.

Speaker Change: We have mentioned, we do not have too is the single arm.

Speaker Change: And no randomization no placebo control.

Sean: So the bars for the conformatory trial is similar to what we had for phase one and phase two. The design is also exactly the same. As we have mentioned, we do not have to, it's a single on and no randomization, no placebo control required, which as you can imagine, that can be quite challenging enrollment to the placebo or randomizing these trials phase three trials. And as far as part of the accelerated path, of course, is the confirmatory trial, but it only needs to be initiated at the time of a BLA submission. And also it's not a requirement for approval that you have finished the confirmatory trial. However, as I mentioned, we are really excited.

Speaker Change: Acquired which as you can imagine that can be quite challenging enrollment to the placebo.

Speaker Change: Or randomized in this trial is our phase III trials and as far as the as part of the accelerated path of course is the confirmatory trial, but it only needs to be initiated at the time of the BLA submission and also its not a requirement for approval.

Helen Sabzevari: And as far as part of the accelerated path, of course, is the confirmatory trial, but it only needs to be initiated at the time of a BLA submission. And also, it's not a requirement for approval that you have finished the confirmatory trial.

You have finished their confirmatory trial. However, as I mentioned, we are really excited not only we have already initiated.

Helen Sabzevari: However, as I mentioned, we are really excited. Not only we have already initiated our confirmatory trial, we have enrolled to our confirmatory trial and based on the reaction of the patients and what we hear from the investigators, that there is a tremendous interest, especially based on the safety and the efficacy that was presented at ASCO by patients to enroll into this confirmatory trial, which obviously being single on, no randomization and exact same designs that we had before and with the patient population that is extremely interested in basically enrolling. We are really excited that what we can do with this innovative treatment for our patients.

Speaker Change: Confirmatory trial, we have enrolled to our confirmatory trial and are based.

Speaker Change: Based on.

Speaker Change: The reaction of the patients on what we hear from our investigators that there is a tremendous interest.

Helen Sabzevari: Not only we have already initiated our confirmatory trial, we have enrolled to our confirmatory trial and based on the reaction of the patients and what we hear from the investigators that there is a tremendous interest, especially based on the safety and the efficacy that was presented at ASCO by patients to enroll into this confirmatory trial, which obviously being single on, no randomization and exact same designs that we had before and with the patient population that is extremely interested in basically enrolling. We are really excited that what we can do with this innovative treatment for our patients.

Speaker Change: Especially based on the safety and efficacy that was presented at <unk> by patients to enroll into this confirmatory trials, which obviously are being single arm no randomization and exact same designs as they had before and.

Speaker Change: The patient population that is extremely interested in that.

Speaker Change: Basically enrolling we are really excited at what we can do with this innovative treatment for <unk> patients.

Speaker Change: Okay.

Speaker Change: Thanks for the additional color.

Speaker Change: Okay.

Speaker Change: Okay.

Jennifer Kim: Thank you. Your next question is from Jennifer Kim from Canter Fitzgerald. Hi, thanks for taking my question. Maybe a follow-up to the last question on the confirmatory trial. Can you talk about what you would expect the pace of enrollment in that trial to look like, maybe in comparison to the prior trial?

Speaker Change: Thank you. Our next question is from Jennifer Kim from Cantor Fitzgerald. Please ask your question.

Jennifer Kim: Hi, Thanks for taking my question, maybe a follow up to the last question on the confirmatory trial can you talk about what you would expect the pace of enrollment in that trial to look like maybe in comparison to the prior trial.

Helen Sabzevari: Thanks for the additional color. Thank you. Your next question is from Jennifer Kim from Canter Fitzgerald. Hi, thanks for taking my question. Maybe a follow-up to the last question on the confirmatory trial. Can you talk about what you would expect the pace of enrollment in that trial to look like, maybe in comparison to the prior trial? Hi, Jennifer. Thanks for your question. Actually, if you recall, the way of phase one was, maybe if you allow me to give a little bit of a history of this, we started our phase one arm in, I think April or May of 2021 in the midst of COVID.

Jennifer Kim: Hi, Jennifer. Thanks for your question.

Speaker Change: Yeah, Hi, Jennifer it's an excellent question excellent.

Helen Sabzevari: Actually, if you recall, the way of phase one was, maybe if you allow me to give a little bit of a history of this, we started our phase one arm in, I think, April or May of 2021, in the midst of COVID. And we have finished the enrollment of our patients by December of 2021 to our phase one. So you can imagine, we had three patients in those level one and 12 patients in those level two, and 15 patients we had already finished in the span of a little bit more than six months. We had started our phase two single arm in January of 2022, and we finished in May of 2023, and that was 23 patients that we again recruited in really very short amount of time.

Speaker Change: If you were to call their way onto the phase one.

Speaker Change: While we maybe I gave and if you allow me to give a little bit of the history of it.

Speaker Change: Have started on phase one.

Speaker Change: Arm in Nab.

Helen Sabzevari: And we have finished the enrollment of our patients by December of 2021 to our phase one. So you can imagine, we had three patients in those level one and 12 patients in those level two and 15 patients, we had already finished in the span of a little bit more than six months. We had started our phase two single arm in January of 2022 and we finished in May of 2023 and that was 23 patients that we again recruited in really very short amount of time.

Speaker Change: I think April or May of 2021 in the midst of Covid.

And we had finished enrollment of our patients by December of 2021 to our phase one so you can imagine.

Speaker Change: We had a 30 patient dose level, one and 12 patients in dose level, two and 15 patients. We had already finished and that has spanned over levered more than six months.

Got it.

Speaker Change: It started our phase two single arm in January of 2022 and we finished in may.

Speaker Change: Of 2023 and that was 23 patients.

Speaker Change: That we again are recruited in.

Speaker Change: Really a very short amount of time and by the way all of the 35 patients during the Covid.

Helen Sabzevari: And by the way, all of the 35 patients, and during the COVID, and at that point, we had not really, in the middle of our phase two, we had started showing our phase one data. So you can imagine now after ASCO, under basically the reception that the PRGN 2012 got through the breakthrough session with hundreds of investigators being there was very clear. Under data and the consistency and safety of the data has added obviously to an interest of all the patients. With this devastating disease that they really have no treatment for, so we have currently many, many, many patients.

Speaker Change: And at that point, we had not really in the middle of.

Speaker Change: Our phase two rehab started showing our phase one data. So you can imagine now after <unk> and.

Helen Sabzevari: And by the way, all of the 35 patients and during the COVID and at that point, we had not really in the middle of our phase two, we had started showing our phase one data. So you can imagine now after ASCO, under basically the reception that the PRGN 2012 got through the breakthrough session with hundreds of investigators being there was very clear under data and the consistency and safety of the data has added obviously to an interest of all the patients.

Speaker Change: And the basically the reception that <unk> 2012 got through the breakthrough.

Speaker Change: Session.

Speaker Change: Yes.

Speaker Change: <unk>.

Speaker Change: Hundreds of investigators being there.

That's very clear and the data and the consistency and safety of their data has added obviously too and interest of all the patients with Devon.

Speaker Change: Devastating disease that they really have no treatment for it so we have a tolerably many many many patients.

Helen Sabzevari: We are not going to guide on the exact timing of this, but obviously you can imagine that we already have initiated; we have started enrollment, and we have a large patient population that they are asking to receive this drug.

Speaker Change: Not going to guide on the exact timing of this but obviously you can imagine that we already have initiated rehab has started enrollment and we have a large patient population that they are asking to recede.

Helen Sabzevari: With this devastating disease that they really have no treatment for so we have currently many, many, many patients. We are not going to guide on the exact timing of this, but obviously you can imagine that we already have initiated, we have started enrollment and we have a large patient population that they are asking to receive this drug. So we are confident that we can finish our confirmatory trials in a very elderly and fast fashion, and we are looking forward to bringing the value to our patients.

Helen Sabzevari: So we are confident that we can finish our confirmatory trials in a very elderly and fast fashion, and we are looking forward to bringing the value to our patients.

Speaker Change: Truck. So we are confident that we can finish our confirmatory trials in a very orderly and fast fashion and we're looking forward to bring the value to our page.

Speaker Change: Sure.

Unknown Attendee: Thanks, Ellen.

Phil Tenant: Thanks, Helen and maybe one question for Phil Phil since your background.

Phil Tennant: And maybe one question for Phil, since your background seems to focus a lot on global development as well. So I'm wondering, is that something you're exploring, and what are sort of the steps to understand what's required to look at XUS markets or when you're thinking about monetization or other strategies. Is that something that you're considering? Thanks.

To focus a lot on global development as well I'm wondering.

Speaker Change: Is that something you're exploring and what are sort of the steps to understand what is required to look at ex U S markets are when youre thinking about.

Helen Sabzevari: Thanks, Ellen. And maybe one question for Phil, since your background seems to focus a lot on global development as well. So I'm wondering, is that something you're exploring and what are sort of the steps to understand what's required to look at XUS markets or when you're thinking about monetization or other strategies. Is that something that you're considering? Thanks. Yeah, thank you for that question. Absolutely. We have global ambition with PRGN 2012, so we would approach market sizing, opportunity assessment, you know, in much the same way that we would do for the US, for instance.

Speaker Change #100: Monetization or other strategies is that something that youre considering thanks.

Phil Tennant: Yeah, thank you for that question. Absolutely. We have global ambition with PRGN 2012, so we would approach market sizing, opportunity assessment, you know, in much the same way that we would do for the US, for instance. And there is a sizable disease burden. Obviously, the unmet need is still high. Different countries have different vaccine programs, but the impact of those vaccine programs for the younger population to float through into the adult population is probably 20 to 30 years out. So we still believe there is a significant commercial opportunity, even in those countries where they do have the vaccine program for younger adults and adolescents.

Speaker Change #101: Yes. Thank you for that question, absolutely we have global ambitions.

Speaker Change #102: <unk> 2012, so we would approach market sizing opportunity assessment.

Speaker Change #102: In much the same way that we would do for the U S. For instance, and there is a sizeable disease burden, obviously, you're unmet need is still high different countries have different vaccine programs, but the impact of those vaccine programs for the younger population to flow through into the idle population is probably 20 to 30 years out.

Speaker Change #102: So we still believe there is a significant commercial opportunity even in those countries, where they do have.

Helen Sabzevari: And there is a sizable disease burden. Obviously, the unmet need is still high. Different countries have different vaccine programs, but the impact of those vaccine programs for the younger population to float through into the adult population is probably 20 to 30 years out. So we still believe there is a significant commercial opportunity even in those countries where they do have the vaccine program for younger adults and adolescents. So, yeah, we are absolutely looking at all of those opportunities, XUS, to build a true global picture of the opportunity. All right. Thank you. Thank you, Dan. Thank you.

Operator: There are no further questions at this time.

Speaker Change #102: The vaccine program for younger adults.

Unknown Attendee: So, yeah, we are absolutely looking at all of those opportunities, XUS, to build a true global picture of the opportunity. All right.

Speaker Change #103: Adolescence so.

Speaker Change #103: Yes, we are absolutely looking at all of those opportunities ex U S to build a true global picture of the opportunity.

Speaker Change #104: Alright, thank you.

Unknown Attendee: Thank you. Thank you, Dan. Thank you.

Tim: Thank you Tim.

Tim: Okay.

Helen Sabzevari: There are no further questions at this time. I will now hand a call back to Dr. Helen Sabzevari for the closing remarks. Thank you very much. First of all, I want to thank you, all of you, for the thoughtful questions. As you can see, this is a very pivotal and exciting time for us at Precigen. We are one step closer to bringing in a first ever treatment to a patient population that is in desperate need of a treatment. I want to take this opportunity to truly thank our team at Precigen for their tireless work over the past several years.

Speaker Change #106: There are no further questions at this time I will now hand, the call back to Dr. Cohen from Giovanni for any closing remarks.

Dr. Cohen: Thank you very much first of all I wanted to thank you all of you for the thoughtful questions.

Dr. Cohen: As you can see this is a very pivotal an exciting time for us at precedent.

Speaker Change #108: We are one step closer to bringing in a first ever treatment for it.

Helen Sabzevari: I will now hand a call back to Dr. Helen Sabzevari for the closing remarks. Thank you very much. First of all, I want to thank you all of you for the thoughtful questions. As you can see, this is a very pivotal and exciting time for us at Precigen. We are one step closer to bringing in a first ever treatment to a patient population that is in desperate need of a treatment. I want to take this opportunity to truly thank our team at Precigen for their tireless work over the past several years.

Speaker Change #108: Patient population that is desperate in desperate need of treatment.

Speaker Change #108: I wanted to take this opportunity to truly tank.

Speaker Change #108:

Speaker Change #109: Our team at prestigious.

The tireless work over the past several years without them.

Helen Sabzevari: Without them, we would have not been where we are today. We could have not delivered what we are delivering for a patient, and I just want to highlight my gratitude and also say I'm a stand privilege to stand next to this team at such a high caliber. So thank every one of the members of this. Of course, we thank our patients for the trust and enrollment, and we are happy with the results that we are seeing for our patients. And finally, I want to thank all of our investigators and all of the physicians that are really treating these devastating diseases out there, which they are outstanding.

Speaker Change #109: Would have not been where we are today, we could have not deliver what we are delivering for our patients.

Speaker Change #109: And I just wanted to highlight my gratitude and also say.

Speaker Change #109: <unk> privilege to sign next to this team at such a high caliber Softbank every one of the members of this of course, we think our patience.

Helen Sabzevari: Without them, we would have not been where we are today. We could have not delivered what we are delivering for a patient and I just want to highlight my gratitude and also say I'm a stand privilege to stand next to this team at such a high caliber. So thank every one of the members of this. Of course, we thank our patients for the trust and enrollment and we are happy with the results that we are seeing for our patients.

Speaker Change #109: For the.

The trust and the enrollment and we are.

Speaker Change #109: Happy with the results that we are seeing for our patients.

Speaker Change #109: Finally, I want as times.

Speaker Change #109: All of our investigators.

Speaker Change #109: And all of the physicians that are really <unk>.

Speaker Change #109: Is devastating diseases out there, which there are outstanding.

Helen Sabzevari: And finally, thank you to all of our shareholders for their continued support.

Speaker Change #109: And finally, thank you to all of our shareholders for their continued support so with that I. Thank you and wish you a great.

Helen Sabzevari: And finally, I want to thank all of our investigators and all of the physicians that are really treating these devastating diseases out there which they are outstanding. And finally, thank you to all of our shareholders for their continued support.

Unknown Attendee: So, with that, I thank you and wish you a great day. Thank you.

Speaker Change #109: Okay.

Speaker Change #109: Okay.

Unknown Attendee: Ladies and gentlemen, the conference has now ended. Thank you all for joining you.

Speaker Change #110: Ladies and gentlemen, the conference has now Andrea. Thank you all for joining you may all disconnect your lines.

Speaker Change #110: Okay.

Operator: So with that, I thank you and wish you a great day. Thank you.

Operator: Ladies and gentlemen, the conference has now ended. Thank you all for joining you