Q4 2023 Precigen Inc Earnings Call

Good afternoon, and welcome to the precedent.

Unknown Executive: Good afternoon, and welcome to the Precigen full year 2023 financial results and update call. At this time, all lines are in listen-only mode.

Chris again full year 2020 financial results and update call.

This time all lines are in listen only mode.

Unknown Executive: Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press star zero for the operator. Please note that this event is being recorded. I would now like to turn the conference over to Steve Harasym, Vice President of Investor Relations. Please go ahead. Excuse me, Mr. Steve Harasym? Please go ahead.

Following the presentation, we will conduct a question and answer session.

Any time during this call you require immediate assistance. Please press star zero for the operator.

Steven Harasym: Please go ahead. Thank you, and I apologize for any technical difficulty here. Again, welcome to our 2023 Cool Year Financial Call. With me is our CEO, Helen Sabzevari, CFO, Harry Thomasian, and Jim Schaefer. Please refer to our most recent filings for our forward-looking statements. With that, I'll turn the call over to Helen. Thank you. Thank you, Steve.

Please note that this event is being recorded.

I would now like to turn the conference over to Steve Harrison.

President of Investor Relations. Please go ahead.

Helen Sabzevari: And thank you to everyone for joining us. And again, apologies for this little bit of technical technical problems. But I think we are going through a very, very transformative year. 2024 is poised to be a transformative year for Precigen. We are on track to present Pivotal Phase 2 data for our Lead Actors PRGN 2012 in Q2 and intend to submit our DLA in the second half of 2024. This is due in part to the positive guidance and pathways provided by the FDA and to the tireless work done by our team over the last several years, starting from the discovery in 2020 all the way to potential filings in 2024. For today's call, I will focus on our AdUniverse platform, and we are working rapidly and prudently to advance our obviously our ultra-car assets, and we are looking forward to the radar readout later this year for our ultra-car platform, as the outline in today's press.

Excuse me.

Mr. Steve Harrison.

Please go ahead.

[music].

Excuse me Steve. Please go ahead.

Thank you and I apologize for any technical difficulty here.

Again welcome to our 2023 full year financial call with me is our CEO, Helen Salisbury, CFO Harrington ACN and Jim Shaper. Please refer to our most recent filings for our forward looking statements with that I'll turn the call over to happen. Thank you. Thank you, Steve and thank you to everyone for joining us and again apologies for that.

Bit of technical problem.

Problem, but I think we are going through a.

Very very transformative yet 'twenty 'twenty four is poised to be a transformational vehicle cost agenda.

Helen Sabzevari: So for today, let me just jump into our ad interest platform, why we are excited about this platform, and our lead asset that it's based on. For those of you who might not be familiar with this platform, this is a very differentiated platform from the rest of the viral platforms. Why do I say that?

We are on track to present, a pivotal phase two data for our lead asset <unk> in 2012 in Q2 and intend on submitting our BLA in the second half of 2024.

This is due impart to the positive guidance on tax rate provided by the FDA and to the tireless work done by our team over the last several years starting from discovery in 2020, all the way to the potential filings in 2020 at four four.

Helen Sabzevari: It's very simple. First of all, this platform is built based on the library of the guerrilla ad. These aginobacteria are not like other aginobacteria. First of all, they have a high capacity so you can put a number of genes in them. But more importantly, they have the ability, because there is no pre-immunity in humans, or very little, you can keep dosing this with this vaccine. With all of the other viral vectors, when you dose once, or at best twice, you're getting this neutralizing antibody, which eventually inhibits immune responses, and then after a while, you're just shooting a bullet. That's one of the major issues with these vectors, other vectors, and other platforms.

For today's call I will focus on our agile platform.

And we are working rapidly and put that through.

To advance our obviously our ultra Claude.

The asset.

We are pushing for what you did there. He died readouts later on to tier four.

Ultra com platform.

As we outlined in today's press release.

So for today, let me just jumping to our AD platform why be odd.

Excited about this platform and our lead assay.

For those of you who might not be familiar with.

Platform.

Helen Sabzevari: Here, on the other hand, because we don't have pre-immunity to this, you can keep on giving, and because of the design of these factors and the specific biological nature of these factors, now, even when there is a neutralizing antibody kept at bay and doesn't enhance it. Why do I say that? We have clinical data from various indications that you can dose the patient, and we have dosed some of the patients up to 18 times. And not only have you kept enhancing their immune responses, but you have kept the neutralizing antibodies at bay. And finally, one other aspect of the platform, which is very important, is the specialized manufacturing process, which allows high titers, and you can imagine that that becomes very important, especially in commercial manufacturing processes.

A very differentiated platform from the rest of the vital platform why do I say that it's very simple first of all the platform.

Based on the library of the Gorilla IV know Baxter you as.

As investors are not like on deck.

First of all we have a high capacity that we can put a number of games.

But more importantly, they have the ability because there is no pre immunity in human or very little you can keep dosing.

With that.

With all of the other.

Weigel backyard when you dose one or at best twice Youre getting good neutralizing antibody with eventually inhibited concept and then after a while you were just shooting a bunch. That's one of the major issues in divestitures, our directors and other platform.

And the other part because we don't have premier niches, you can keep on giving and because of the design of these factors on the specifics.

Helen Sabzevari: So let's dive into our lead asset, which is our PRGN2000. Our PRDM 2012 was designed to identify the epitopes HPV6 and 11 and target the cells that are infected with this virus. Why is that important? In a rare disease of basically RRP or recurrent respiratory papillomatosis, the root cause of this disease is the HPV 6 and 11 infection in this patient, which then causes these benign tumors on the vocal cords or in the trachea of this patient. Therefore, they can't talk, or they can't breathe or read, for that reason, they have gone through a devastating disease with really no treatment except surgery. What does surgery do? I keep removing this benign tumor. It's like mowing your grass, and then they keep coming back.

In biological nature.

Now even with the ease of neutralizing antibody.

And does it enhance it why do I say that rehab clinical data actually come in various indications that you can be dosing the patients on behalf does some of the patients up to 18 times.

Not only you have chef enhancing the immune responses, but you have chips and neutralize they have to button.

And finally, one other aspect.

The platform, which is very important is the specialized manufacturing profit rich.

Hi, Tyler I mean, you can imagine that becomes very important, especially in commercial manufacturing process.

Let's dive into our lead asset, which is our <unk> 2012.

I P O Jim 2012 has been to design.

To identify the epitopes HPV.

Helen Sabzevari: And as a result, the patient, first of all, the situation gets worse, there is a danger, and there is a continuous problem that you have not solved. In order to really address this disease, you have to get to the root, which means what? It means that you have to address the infection underlying HPV6 and LV. And this is exactly what we designed PRGN-2012 to do, to awaken the immune responses of these patients to identify these cells that are infected and cause the benign tumors to grow, and then to destroy them. And based on that, what we have done is looked at the number of patients. In the United States, it is estimated that between 15,000 to 20,000 patients have aura. Ex-US, you are looking at an excess of 125,000.

11.

Alright.

Target.

That's it with his wife.

Why is that important in that rare disease, all basically all of our key or recurrent respiratory papillomatosis their root cause.

If the infection HPV six and 11 infection in these patients.

Which then causes benign tumors on the vocal cord or in the trachea obese patients.

Therefore, they can't talk.

Or they can breathe for booked.

Accretion.

Dr Chang.

I've gone through the.

Devastating disease.

Really no treatment, except one.

What does surgery deal.

Removing the non tumor recollect moly you're correct.

And then they keep coming back and as a result, the patient first of all what it gets worse the situation there is a danger.

Continue with problems that you have now.

In order to really at risk you have to get to the root which.

<unk> means.

That you have to add the red the infection underlying H P.

Helen Sabzevari: So, as we mentioned, this is truly a devastating disease with no current treatment. When we started our tribe with PRGN-2000, 12. We, first of all, designed the trial so that the patient has a history of the patient for 12 months prior to receiving their vaccine, and then these patients receive a course of four vaccinations within 85 days. And then after that, we have been following these patients to see for the recurrence of this denial tumor. In a single-arm phase one pivotal trial that we ran originally, what we observed was, first of all, from a safety perspective, these patients had very favorable safety, mainly grade 1, grade 2, which is some rashes at the site of injection, or, And then it resolved within a day or two. Very similar to the flu shot. Secondly, one thing that was very specific about our design for this vaccine is that it's given subcutaneously in the arm or leg, again, similar to the flu shot. We don't require any kind of device.

And this is exactly what we designed pier G in 2012 to do.

Of Beijing.

Immune responses of these patients to identify T cells that are infected and Claude benign tumors to grow and then.

Right.

And based on that.

What we have done it.

Looked at the number of the patients in the United States There are.

The major between 15 to 20000 patients.

That they have all the T X.

Ex U S. You are looking at exit hundreds and 25 constant page.

So as we mentioned this is truly a devastating disease.

With no current treatment.

When we started a trial with <unk> 2012.

12.

We first of all designed to clot subject patient we have the history of depletion in 12 months.

Prior to receiving <unk>.

And then the patients may receive a cortisol or explanation within 85 day.

And then after that we have been following the patient to keep with the recovery of the benign tumor.

Helen Sabzevari: We don't require anything. It can be done in any office of any physician, right? So now, what we saw, besides the safety and the endpoints that we had set, we decided to go to the most severe patient population. What do we mean by that? We define that, and our KOLs and investigators have defined it as patients that at least require three surgeries in a prior year. Actually, the average number of surgeries that our patients had in our trial was upwards of six surgeries per year. So you can imagine, every couple of months, this patient had surgery. Some of them, they had 10 surgeries in the previous year. What do we observe? Why?

Please note on phase one pivotal trial that we run what are you generally what we observe what first of all from a safety perspective.

These patients had a very favorable thing.

Mainly grade one grade, two which roger but the price of injection or smoke.

Steve.

It resolved within a day or two very similar to the flu shots.

Secondly, one thing that was very specific about.

Designed for this vaccine is that is given subcutaneously or more like again similar to the flu shot we don't require any kind of if you want we don't require anything can be done in any altra.

Right.

So now.

Helen Sabzevari: After the follow-up of 12 months, 50% of these patients did not require any surgery, and we refer to them as a complete response. If we look at the overall patient population, and see that they reduced their number of surgeries, we are looking at an 83% rate. Okay. Now, when we look at the immunological responses of these patients, the patients that had a complete response, they had a significant increase in their immune responses to HPV6 and 11. And this is exactly what the mechanism of this vaccine is all about.

What we call besides the safety and the endpoint that we had put we decided to go to the more severe patient population what do we mean by that.

We defined that on our Kols and investigators of defined that at.

Patients that actually require three surgery in the prior year.

Actually the average number of surgery patient hot.

What upward the peak surgery per year. So you can imagine it would be.

Helen Sabzevari: At the same token, one thing that we have to say is that we have been following these patients for more than 12 months now. Actually, these patients are in full response, and they are upwards of 24 months. This is two years after vaccination.

This patient had a surgery some of them they have temperatures in our pricing.

What we observe.

What.

The follow up of 12 months.

The cornerstone of the patients did not require any surgery.

To sum up this complete response yet.

It did not yet.

Helen Sabzevari: And again, I'm going to stress, the severe patient population, with the average number of surgeries set, the mean average, right? So when we look at it, we also have. Based on the data, the safety, and the efficacy, the FDA last year, for the first time in the history of any company, gave us a breakthrough designation as well as an accelerated path and agreed that our single-arm pivotal phase one data plus a single-arm phase two, which we had started, could act as pivotal, and based on that, we can submit a bill. So, as we have mentioned, last year, we finished We already have published in Science Translation our complete Phase 1 data and the mechanism of action of that.

Overall patient population that they reduce the number of third party. We are looking at 83% response rate.

Okay now when we look at the immunological responses.

Asia.

Patients that they had the complete response they have.

The significant increase in the immune response to HPV six and 11 and this is exactly what the mechanism of the vaccine is all about.

At the same token one thing that we have to say we have been following now the patient for more than 12 months actually these patients are in poor response.

They are upwards of 24 months. This is two years after vaccination and again I'm going to stress GBM patient population with the average number of surgery.

Main average right.

So when we look at all so we had.

Based on the data the safety the efficacy the FCA last year for the first time in the history of any company.

Hi.

Given.

Breakthrough designation as well as accelerated path.

And I agreed that at Zynga.

Helen Sabzevari: And we are poised to submit our BLA in the second half of this year, and we have received an agreement from the FDA that we are enrolling for the BLA. So, as you can imagine, this is quite exciting and also a proof of concept for this platform. Simultaneously, we have been advancing another molecule, PRGN-2009, and that has already been positioned in HPV 16 and 18 cancers, have a neck cancer, cervical cancer, and the Phase II studies in Head and Neck were initiated last year, and we are currently enrolling and recruiting patients for this R in head and neck with the early onset of the disease. And this is quite exciting. Why?

Single arm pivotal phase one data.

Plus the single arm phase two which we have just started.

And as a pivotal and based on that because submit a BLA.

So as we have mentioned last year, we finish the enrollment to our phase III and we are really excited that we will be presenting the full dataset of our phase III by the end of Q2.

Already have published in science translation.

Complete phase one data.

The mechanism.

<unk> of that.

We are posed.

<unk> stopped Mig.

BLA in the second half of year.

We have received an agreement from the SBA that we have that rolling BLA.

So as you can imagine this is quite exciting and also a proof of concept for the platform.

Simultaneously, we have been advancing another molecule.

Helen Sabzevari: Because when you look at the head and neck, the response rate of the patient, even to the checkpoint inhibitor, has been 18%. So there is a wide gap here for improvement. Last year at, we showed that when we treated HPV-related cancer patients, these are stage 4 patients. These patients basically had 30% objective return, partial responses, complete responses, and complete responses were durable. We had over a year. This is in a patient population that I stress again. Checkpoint inhibitors in cervical cancers were 15%, and then they fell, or in the head and neck, 18%.

<unk> 2009.

And that.

It has been.

Already positioned in HPV.

<unk> and 18 cancers.

Net term debt.

The recall chapter.

Hi.

Two studies in head and neck.

Initiated last year, and we are currently enrolling and recruiting patients to this at.

Oh, seven net with the early onset of disease.

This is quite exciting one because when you look at the response rate of the patients even to the checkpoint inhibitor has been 18%.

Well.

Why Jack here.

Right.

Last year at Agco, we show.

When we treat it HPV related cancer patients. These are the stage four patients.

Helen Sabzevari: So now positioning PRGN-2009 in a head and neck in combination with the tembro. In an early onset, it's quite exciting. And this trial is recruiting and we have enrolled patients to this. Simultaneously, we moved this asset towards the cervical cancer. Last year, we received an IND approval from FDA to open the Phase II study in combination with PEMRO in a relapsed metastatic cervical cancer patient, and currently as we, We are recruiting to this trial and this is quite exciting. So as you can imagine, this platform, with the differentiation that it has from all the other platforms, with the efficacy that has shown and in our lead PRGN 2012, based on its safety, clinical efficacy, and also in discussions with the KOL and investigators, the high excitement about this molecule for this rare disease because of ease of administration, because of efficacy of clinical response, and the durability of response has generated a lot of excitement and really has positioned us to become a leader in treatment for this rare disease. So with that as a highlight.

This patient.

Basically we had 30% objective responses.

Partial responses.

Police responses and complete responses.

What durable we had over a year.

The health response in some of these patients. This is in a patient population that are stressed with checkpoint inhibitor and cervical cancer.

We push that.

They fail.

<unk>, 18%.

So now positioning PRT in 2009, and assure that neck in combination with the temporal in the early onset.

This exciting.

The trial is recruiting.

<unk> got we have enrolled patients to take on.

Simultaneously, we moved this asset towards the recall chapter last year, we received.

IND approval from SBA two opened a phase two study in combination with Pembroke.

At relapsed metastatic cervical cancer patients.

And currently as we speak.

We are recruiting to destroy it and this is quite exciting.

You can imagine this platform.

The differentiation, but it's half from all the other platform with the efficacy that has shown.

In our lead <unk> 2012 were based.

Harry Thomasian: I would like to now actually transfer to Harry Thomasian to give us, our CFO, an update on our program. Thank you, Helen. And good afternoon to those on this call. We appreciate you participating. As Helen mentioned earlier, 2024 is shaping up to be a transformative year for Preston.

Based on safety Kleen.

Clinical efficacy and also in discussions with the Kols and investigators that high excitement at Bob These molecules for Greg.

Ease of administration because of efficacy clinical response.

The durability of response has generated a lot of excitement and really has positioned us to become a leader in.

Harry Thomasian: We are well on our way to the completion of our drug substance manufacturing facility here in Germantown, Maryland. And with the hiring of our head of commercial operations in September of this past year, we are continuing to build out our commercial function and plan to be ready for the expected launch of PRGN 2012 in 2025. In addition, we anticipate that there will be multiple value inflection points in 2024, starting with our data readout on PRGN 2012 in the second quarter of this year.

Treatment for this rare disease.

So with that.

The highlight.

I would like to now actually transfer to Harriss Tomas here to give us our CFO an uptake on outbound Nacho alright. Thank you Helen and good afternoon to those on this call. We appreciate your participation.

As Helen mentioned earlier 2024 shaping up to be a transformative year for press agenda. We.

We are all well on our way to a completion of our drug substance manufacturing facility here in Germantown, Maryland.

And with the hiring of our commercial operations in September of this past year.

<unk> to build out our commercial function and plan to be ready for the expected launch of <unk> in 2012 in 2025.

Harry Thomasian: As we approach the end of the first quarter of fiscal 24, we're continuing to exercise sound financial management, preparing for the planned launch of PRGN 2012 and 2025 and continuing to move our other programs rapidly through the clinic, all while maintaining efficient SG&A operations. With that in mind, I'd like to spend a few minutes highlighting certain aspects of our financial results for 2023. In 2023, our research and development expenses were $48.6 million, an increase of 3% or $1.4 million from the prior year. This was primarily due to additional investment in our personnel, mostly through adding additional headcount to support the growth in the company's development activities. Our continued focus on SG&A costs resulted in a decrease of 16%, or $7.6 million, from the prior year to $40.4 million for the full year of 2023.

In addition, we anticipate that there will be multiple value inflection points in 2024, starting with our data readout on <unk> in 2012 in the second quarter of this year.

As we approach the end of the first quarter of fiscal 'twenty four.

We're continuing to exercise sound financial management preparing for the planned launch of <unk>, 2012, and 2025 and continuing to move our other programs rapidly through the clinic, all while maintaining efficient SG&A operations.

With that in mind I'd like to spend a few minutes highlighting certain aspects of our financial results from 2023.

In 2023, our research and development expenses were $48 $6 million, an increase of 3% to $1 4 million from the prior year.

This was primarily due to additional investment in our personnel, mostly through adding additional headcount to support the growth in the company's development activities.

Our continued focus on SG&A costs resulted in a decrease of 16% for $7 $6 million from the prior year to $44 million for the full year 2023.

Unknown Executive: This was due primarily to reduced legal and insurance costs and was achieved while we began to build out our commercial group. We filed our 10-K with the SEC just prior to this call, and you can find more detailed financial information in the financial statements which are included in the 10-K. In addition, we are continuing to evaluate various opportunities and are confident in our ability to strengthen our balance sheet as we approach the planned launch of PRGN 2012 and transition from a clinical to a commercial stage company. This concludes our prepared remarks for today. I'll now turn it over to the operator for any questions. Thank you, ladies and gentlemen. Thank you, ladies and gentlemen.

This was due primarily to reduced legal and insurance costs and was achieved while we began to build out our commercial group.

We filed our 10-K with the SEC just prior to this call and you can find more detailed financial information in the financial statements, which are included in the 10-K.

In addition, we are continuing to evaluate various opportunities.

And are confident in our ability to strengthen our balance sheet as we approach the planned launch of <unk> in 2012, and transitioning from a clinical to a commercial stage company.

This concludes our prepared remarks for today I'll now turn it over to the operator for any questions.

Yeah.

Thank you ladies and gentlemen.

Thank you, ladies and gentlemen, we will now conduct a question and answer session. If you have a question. Please press star one on your telephone keypad.

Unknown Executive: We will now conduct the question and answer session. If you have a question, please press star 1 on your telephone keypad. If you wish to cancel your request, please press start soon. Please ensure that you lift the handset if you are using a speakerphone before pressing any key.

If you wish to cancel your request please press star two.

Researchers to lift the handset if youre using a speakerphone before pressing into key.

Unknown Executive: And as a reminder, kindly limit your question to one initial and one follow-up question only. Thank you. Your first question comes from Jennifer Kim from Cantor Fitzgerald. Her line is now open.

And as a reminder, kindly limit your question to a one initial and one follow up question only okay. Thank you.

Your first question comes from Jennifer Kim from Cantor Fitzgerald.

Line is now open.

Okay.

Okay.

Jennifer.

Your line dropped.

Helen Sabzevari: Your next question comes from Jason Butler from Citizens JMP. Your line is now open. Hi, thanks for taking the questions, and congratulations on all the progress. To the two from me, first of all, in terms of the PRGN 2012 Phase 2 trial, can you maybe just compare the trial design here, patient population, and anything about trial conduct to the Phase 1 study that we already have the data from and note any differences? And secondly, Helen, at this point, any more color you can give us on the design of a confirmatory study that you would conduct for 2012, assuming you've got accelerated approval? Thank you. Hi Jason.

Your next question comes from Jason Butler from citizens JMP. Your line is now open.

Hi, Thanks for taking the questions and congrats on all the progress.

Two for me first of all in terms of the PR Gen 2012 phase III trial can you maybe just compare.

The trial design here patient population anything about trial conduct to the phase one study that we already have the data from <unk> and no any differences and secondly, Helen This point anymore color you can give us on the design.

The confirmatory study that you would conduct for for 2012, assuming you got accelerated approval. Thank you.

Hi, guys and thank you excellent question.

Helen Sabzevari: Thank you. An excellent question. So, in regard to the Phase 1 and Phase 2 studies, actually, the design is exactly the same, and this is why FDA has allowed us to combine the Phase 1 single arm and the Phase 2 single arm and consider that as a pivotal study. So, we are really excited about that. There was no different design between these two, and the data will total 35 patients for which data will be reported. In regard to the confirmatory trial, also, we have already reached full agreement with the FDA already that the confirmatory trial would exactly duplicate what we have done in a single-arm phase one and phase two. So it's the exact same design.

In regards to the phase one and.

Two.

Actually the design.

Exactly the same on this as well.

Why.

<unk> had.

<unk> got to combine that.

One single arm phase two.

And the law and they considered that.

Capital. So we are really excited about that that would no.

Different.

Different design between the two R&D will total 35 patients.

<unk>.

Data would be reported.

In regard to the confirmatory trial also we have the full agreement with the FDA already that the confirmatory trial.

Lastly, duplicate what we have done in the single arm phase one and phase two.

Exact same designs. However, one interesting point here and I think it's very very important.

Helen Sabzevari: However, one interesting point here, and I think it's very, very important, that based on the safety and the efficacy that we showed, and the FDA has seen that data, FDA has recommended that we also consider an arm. This is not a requirement for a confirmatory trial; this can be separated or done differently, however, or we can even add it to the confirmatory trial if we wish to. But for a repeat dosing, because the consideration that those 80, the other 50% of the patients who didn't go to a complete response, however, they benefited, and they reduced the number of surgeries; they might be able to go towards a complete response. And We are really excited about that. We already have the design for the confirmatory based on what we had designed before.

Important that based on the safety and the efficacy that we showed.

And the FDA has seen that data.

<unk> had recommended that we also did that.

This is not a requirement for the confirmatory did can be separate.

<unk> done differently, However, God weekend, you've been added to the confirmatory trial, if we wish to but for repeat dosing because the consideration that dose.

The other 50% of the patients that they didn't go to a complete response, however, the benefit and they reduce the number of surgery they might be able to go towards a complete response and we are really excited about that.

Already have the design of confirmatory based on what we had been buying before and clearly upon our BLA submission our confirmatory trial will start.

Helen Sabzevari: And clearly, upon our BLA submission, our confirmatory trial will start, and is going to be initiated primarily. Great. Very, very helpful.

It's going to be initiated that simultaneously.

Okay.

Great very very helpful. Thank you Helen.

Unknown Executive: Thank you, Helen. I'm sorry, your next question comes from Jennifer Kim from Cantor Fitzgerald. Your line is now open. Hey, can you hear me?

Thank you.

Your next question comes from Jennifer Kim from Cantor Fitzgerald. Your line is now open.

Hey can you hear me.

Unknown Executive: Yes, Jennifer. Oh, perfect. Sorry about that earlier. Maybe to start off, have you decided on your plan in terms of the format or venue for presenting the phase two data? And then my second question is just from a commercial readiness standpoint, can you give more color on the manufacturing side and how much capacity do you anticipate having at the timing of a potential launch? Thank you, Jennifer.

Yes, Hi, Jennifer.

Oh, perfect sorry about before maybe to start off have you decided on your plan in terms of the format or venue for presenting the phase II data.

And then my second question is just from a commercial readiness standpoint can you give more color on the manufacturing side and how much capacity do you anticipate having a timing of a potential launch thanks.

Thank you Jennifer so from the obviously we are looking at.

Helen Sabzevari: So obviously, we are looking at the various options that we have, and we will give a little bit more guidance as we get closer. But clearly, we are looking forward to presenting the full set of data on our case to you and our investigators, also. So we will be guiding soon. In regard to commercial readiness, our commercial facility is actually, is exactly moving according to the plan.

The various options that we have and we will give a little bit more guidance as we get.

Closer.

But clearly we are looking forward.

To presenting the full set of data.

Akshay do you and the other investigators outflow timberland b, so we will be guiding.

Sue.

In regard to the commercial readiness.

Commercial.

He is actually.

Exactly moving according to the plan.

Helen Sabzevari: And we will have a capacity at the time of launch to meet not only the number of patients but actually, by then, have generated thousands of doses that the patients can be treated with. So we are confident that we can meet the needs of the commercial, basically, force and our patients as we move forward. Okay, that's helpful. And maybe to follow up on what you said before on the arm to look at repeat dosing. Is there any data or feedback that you're waiting on before you sort of pull the trigger on making that decision?

And we will have a capacity.

At the time of launch to meet not only the number of the patients.

Actually we have by Dan.

Generate that.

In the thousands of doses.

The patients can be treated with so we are confident that we can meet the needs of the commercial.

Basically forced.

There are patients as we move forward.

Okay. That's helpful and maybe to follow up on what you said before.

The orange.

Look at repeat dosing is there any data or feedback that you're waiting on.

Before you.

Pulled the trigger on making that decision.

Helen Sabzevari: No, actually, that is the arm that the design is, has been up to us because that is not a requirement for a confirmatory trial from the FDA. Our confirmatory trial is already approved by the FDA, and it's actually in the process, as I mentioned, upon our submission of the BLA. We also have initiated that going forward. The repeat dosing is what we have designed in conjunction with our investigators and that we will also add as part of our confirmatory as another arm. But then again, that is not a requirement by the FDA. This is additional to expand our label and expand the patient population that can benefit from repeat dosing, especially with the durability that we see currently, which is more than 2 years. Okay, I got it.

No actually that is the arm that.

The design is.

<unk> been up.

Up to us because that is not a requirement for the confirmatory from FDA.

Confirmatory trial.

Already.

Louise by FDA.

Actually.

In the process as I mentioned upon our submission of the BLA, we also initiated that.

Going forward there.

<unk> dosing is what we.

Hub design in conjunction with our investigators.

We will also add a part of a confirmatory as another arm of them again.

It's a requirement by the SBA. This is additional to expand our label.

Expand the patient population that they can better.

From the peak dose.

Especially the durability that we see currently which is more than two years.

Okay.

Okay got it that's helpful. Thanks Alan.

Unknown Executive: That's helpful. Thanks, Helen. Your next question comes from Swayam Pakwal Ramakant from H.U.

Yes.

Sure.

Yes.

Your next question comes from.

William Bock while.

<unk> from HC Wainwright.

Unknown Executive: Wainwright, your lines are now all. Thank you. This is O.K. from HBNR.

Your line is now open.

Thank you this is RK from Pennsylvania.

Unknown Executive: Good afternoon, Helen and Harry. I have one question about 2012. In terms of, you know, commercializing the drug, can you give us some of the aspects of it in terms of like sales folks and what sort of, you know, what is the strategy there? And with it being an orphan disease, do you focus on some specific centers where this is being treated? Just some of the dynamics of that, please.

Good afternoon.

Right.

So.

I have one question on 2000 tall.

In terms of.

Commercializing.

The drug.

Can you give us.

Yes.

Some of the.

By suffered in terms of late sales folks and what sort of.

<unk>.

Or does the strategy there.

Yes.

Is it being an orphan disease.

I mean do you focus on some specific centers around readiness is being treated.

Just some of the dynamics of that please.

Jim Schaefer: I'm going to ask Jim Schaefer, head of our commercial department, to actually give colors to that. Thank you, Helen. We have recently completed primary and secondary market research to better understand not only the patients but also the physicians and the prescribers who currently manage these patients across the US. And, you know, what we continue to identify is that it's a relatively small group of specialty physicians, primarily laryngologists, which are subspecialty positions that are managing these patients.

Im going to ask Jim Shaffer head of our commercial too actually.

Colors to that thank you Allen.

We have recently completed primary and secondary market research to better understand not only the patients but also the physicians and prescribers you currently manage the RP patients across the U S and what we continue to identify is that it's a relatively small group of specialty.

It is primarily laryngologist, which are a sub specialty the positions that are managing.

Jim Schaefer: The large majority of patients, so we will be able to create, hire, and train a specialty sales team focused in the major metropolitan areas and be very efficiently able to increase awareness, launch, and then promote our product once approved. Okay, thank you for that. And then going off onto the Ultracore T cell therapies, the 3007, where you're doing the dose escalation study now and hoping to present some preliminary data, you know, what sort of data we would see in terms of like the dose ranges and also, you know, how soon you can get into phase two based on what, you know, what you get to see from this, this portion of the study. Yeah, no, thanks.

The large majority of patients so we will be able to.

Create hire and train a specialty sales team focused in the major metropolitan areas and various sufficiently be able to.

Increase awareness lodge and promote our product once approved.

Yes.

Okay. Thank you for that and then going off onto the ultra car T cell therapies.

007.

Rare.

Youre doing a dose escalation study and are.

Hoping to present some preliminary data.

What works and what sort of.

Data, what we see in terms of like the dose ranges and also.

How soon can you get.

Get into phase two.

Based on the work.

Once you get to see from this portion of the.

Of this study.

Yes, no. Thanks.

Helen Sabzevari: Okay. So, in this trial, actually, based on our prior trials, we are actually in a two-duo cohort here. However, this is an umbrella trial, as we have mentioned before, that basically means we are addressing a number of indications, both hematological, as well as solid tumor, especially triple negative breast cancer. So, this is going to be very exciting.

Okay. So it.

In this trial.

Based on our <unk>.

Prior trial.

We are.

There is a two dual cohort here, however, diesel umbrella trial as we have mentioned before.

That basically means we are addressing number of indication bullet Tim its a logical as well as solid tumorous specialty triple negative breast cancer can be very exciting.

Helen Sabzevari: And what we are looking at, the guidance that we have given, we will be giving some updates on the interim data by the end of 2024. And we will be moving upon the dose selection as well, obviously, finishing all of the safety, then the trial moves to the expansion phase, phase 1B. And, again, those are the discussions that, based on the data that we will see, we will have with the regulatory body, the same type of things as we currently have with, for instance, our AML, which is in a patient population where they really have no other option in front of them. And, as you are aware, other CAR-Ts and TCRs have not been able, or even the off-the-shelf, have And also, small molecule inhibitors, unfortunately, address only a certain percentage, 6-7% of the patients that they have those mutations, for instance, in select trees.

What we are looking at the guidance that we have given we will be giving you some updates on the interim data by the end of 2024.

We will be moving.

Upon the dose.

Its selection as well, albeit finishing all of the safety.

That trial moves to the expansion phase phase one b and again those are the discussions that based on the data that we will see we will have with the regulatory body.

The similar type of thing would be currently.

<unk> 48.

AML, which is in a patient population that they really have no option in front of them.

As you are aware other car T and TCR.

<unk> not been able or even the off the shelf have not been able to.

<unk> in two debt arena and also a small molecule inhibitors. Unfortunately is address that.

Only.

The percentage to 7% of the patients that they have those mutations places intellectually.

Helen Sabzevari: And, as we have seen, based on the data, those patients, unfortunately, after a year, also have a mutation in their tumors, and they relapse, and they have to look for other options. So, I think we are really excited about that, our CAR-T and the results that have been showing, and then, as we have given the guidance, by the end of 2024, we will present data on expansion. Perfect.

As we have seen based on the data on those patients. Unfortunately after a year also that there is a mutation that tumors and they relapse and they have to look for other options. So I think we are really excited about that.

A coffee and the results that have been showing and then we will be as we have given the guidance by the end of 2020 for a week.

Presented data on the expansion.

Perfect. Thank you. Thank you very much cherilyn.

Helen Sabzevari: Thank you. Thank you very much, Helen and team, for taking the question. Thank you. Your next question comes from Brian Chang from JP Morgan. Your line is now open.

Taking my questions.

Thank you.

Yes.

Your next question comes from Brian Chen from JP Morgan. Your line is now open.

Unknown Executive: Hey guys, thanks for taking our questions today. The first one is on RRP prep. So based on your market research, how should we think about the initial adoption trajectory within RRP if you were approved today? Is there a lot of pent-up demand?

Hey, guys. Thanks for taking our questions today.

First one is on your.

First one is on the RFP perhaps.

Based on your market research, how should we think about the initial adoption trajectory within the RFP. If you are approved today.

Is there a lot of pent up demand or do you think that this will be a small build over time type of launch and I have a quick follow up thank you.

Unknown Executive: Or do you think that this will be a slow build-up over time type of launch? And I have a quick follow-up. Thank you. Okay, I think Brian. I'm going to let Jennifer answer that, and I can add to that as well.

Okay, I think Brian I am going to let Jim Schaeffer answers that I can add to that.

Unknown Executive: Yeah, Brian, thanks for the question. As I mentioned earlier, you know, we recently completed a commercial market assessment for the US and the rest of the world markets for RRP and for PRGN 2012. We feel, you know, like overall uptake is going to be relatively swift because a large majority of the patients are sitting and managed by a relatively small number of laryngologists across the U. S. So, you know, as we educate and increase awareness about the product availability, we think that's going to be relatively quick with those physicians and patients. So, you know, whether it's a 3 or 4 year uptake curve to peak, and then Does that answer your question? Yes, it does. So maybe just on expenses, how should we project sales-related expenses as you prepare for the launch? Any color on the projected cash runway?

Yes, Brian Thanks for the question as I've mentioned earlier, we recently completed a commercial market assessment for the U S and the rest of the world markets for RP.

<unk> 2012.

We feel like.

Right.

Overall uptake is going to be relatively swift because a large majority of the patients in our setting and managed by a relatively small number of laryngologist across the U S.

So as we educate and increase awareness about the product availability.

We think that's going to be relatively quick with those physicians and patients.

So whether it's a <unk>.

Three or four year uptake curve to peak.

And then there was some level of re treatment that occurs.

For the rest of that the overall sales build over time does that answer your question.

Yes, it does.

So on May.

Maybe just on expenses.

Should we project sales related expenses as you prepare for the launch.

Any color on the projected cash runway and.

Helen Sabzevari: And what are the latest updates on the partnership for Ultracart? Okay, so I can take some of this, and then definitely Harry can add to it. In regard to our, as Harry mentioned, we are looking at the various strategies for basically supplementing our financial balance sheet, and we are confident that we, as we move forward, we have that ability. In regard to the ultra CAR-T, actually, I'm glad you asked that question because, as you can imagine, especially with the evolution and the scenarios that have happened, we saw in the past six months the change of the label for the reason that the classical CAR Now this puts another cloud on the field of autoimmunity using this classical CAR-T because in a cancer patient, of course, you're dealing with the indication that patients have no option, and they have no other treatment.

What is the latest update on the partnership Arlo Ultra car T.

Okay. So I can take that.

Some of this and then.

Definition of how we can add to it.

In regard to.

Harry mentioned, we are looking at the variant.

Strategy.

Sure.

Basically supplementing our financial balance sheet, and we are confident that we.

As we move forward, we have that ability in regard to the ultra car T. Actually I'm glad you asked that question because as you can imagine, especially with that.

Evolution.

The scenarios that have happened we saw all in the past six months with change of the label even in the approved car T for the reason that the classical coffee. Unfortunately, some of the patients have come down.

Cancers.

<unk> car T and now that has to be projected.

The label.

Same token now puts another cloud on the field of auto immunity using the classical car T.

And a cancer patient of course dealing with the <unk>.

The indication that the patients have no option and they have no other treatment on the other hand, when you are looking at the chronic diseases such as lupus community. Clearly now you have to have a very very safe blocks.

Helen Sabzevari: On the other hand, when you're looking at chronic diseases such as lupus or autoimmunity, clearly, now you have to have a very, very safe drug because number one, these are not patients that are at stage four. These are patients who can live for long periods of time and, secondly, most probably, they have to be re-dosed with their chronic disease. So in that setting, you have to have, [inaudible] Number two, the cost. It becomes very, very important, especially in chronic diseases, because as we can see currently, even the cost of a cancer indicator is not bearable on our system, left alone. Now you go to the chronic For those reasons, the platform that we have developed, and it's moving forward.

Because number one these are not patients that are stage four and these are patients that they can look for long periods of time.

Secondly, most probably they have to be re dose over their chronic HBV.

In that study you will have to have.

Two phenomena number one.

To ensure that someone that would have had otherwise along light you cannot be exposing to the scenario that there might be.

Developed cancer as a result of the treatment that they receive.

Chip.

Because it becomes very very important especially remained chronic diseases.

As we can see currently even the cost in a cancer indication is not variable on our system.

Left alone value both to the chronic.

For those reasons.

What form that we have developed and it's moving forward.

Helen Sabzevari: And by the way, across indications. We have now treated more than 70 patients with this platform, and number one, the ease of manufacturing overnight at the hospital, which then does not require the costs that are associated, as you can imagine, with centralized manufacturing. And number two, the design of these cartoons that we have currently, which do carry safety switches within them, so if anything goes wrong, you can eliminate yourself.

The way across.

Indications.

Have now treated more than 70 page.

Platform.

Number one.

As of the manufacturing overnight at the hospital, which then does not required the cost.

<unk>.

Can imagine with centralized manufacturing and number two the design of these costs that we have currently which do Charlie safety switches within that with under if anything goes wrong you can eliminate.

Helen Sabzevari: Thankfully, we have not had to activate it, but obviously, we have done all of the preclinical studies. And, of course, these were part of our IMD packages that were given to FDA. And I think this is the advantage that, currently, our cartoon, the combination of those two factors, obviously has created a lot of excitement and also attention.

Thankfully, we had locked to activate itself, but obviously, we have done all of the preclinical studies and of course, we will talk about these packages that was given to SG&A and I think he is Atlantic that currently our car T and the combination of dose two factor.

We have created a lot of excitement and also essentially so we will be updating as we move forward in regard to orange.

Harry Thomasian: So we will be updating you as we move forward and with regard to our basically partnership activity. But this is going to be very exciting. And Brian, I'll touch on your question about cash runaway. I'll start with historical cash burn. So last year 2023, our cash burn was about 68 and a half million dollars, or an average of about 5.7 million per month. You know, there'll be some increased expenditures with the build out of commercialization and manufacturing capabilities, but through financial management, we're trying to reduce spend in other areas of the company.

Basically partnership activity.

This is going to be a very exciting year.

And Brian I'll touch on your question around cash runway, we will start with.

The historical cash burn so last year in 2023.

Cash burn was about $68 million or an average of about $5 7 million per month there'll be some increased expenditures with the build out of commercialization and manufacturing capabilities, but through financial management, we're trying to reduce spend in other areas of the company.

Harry Thomasian: I will go back to my prepared remarks and reiterate that we're continuing to evaluate various opportunities and we are confident in our ability to strengthen our balance sheet as we approach the planned launch of PRG in 2023. Thanks for the color. Thank you. Ladies and gentlemen, as a reminder, should you have any questions, please press the star followed by the number one. I see no further questions, Lester.

Go back to my.

Prepared remarks.

To reiterate that we're continuing to evaluate various opportunities and we are confident in our ability to strengthen our balance sheet as we approach the planned launch of PRT in 2012.

Yes.

Okay.

Thanks for the color. Thank you.

Okay.

Yes.

Ladies and gentlemen, as a reminder, should you have any questions. Please press star followed by the number one.

I see no further questions luster, let's turn it back to Helen for concluding remarks.

Helen Sabzevari: Let's turn it back to Helen for her concluding remarks. Thank you, operator, and thank you to all of those that joined us for our update call today. As you can see, 2024 is poised to be a transformative year for us at Precigen, especially as we transition from a clinical to a commercial stage. With Pivotal Phase II data underway and the plans to submit a BLA in the second half of this year, we are poised to deliver health to patient populations with no alternatives and drive shareholder value. We look forward to communicating further in the coming weeks and months. Thank you again for joining us. Ladies and gentlemen, this concludes today's conference call. Thank you for joining us. You may now disconnect.

Operator, and thank you to all of those that joined US this quarter our update call today.

C 2024 is poised to be a transformative year for us at <unk>.

Especially as we transition from a clinical to a commercial company.

Pivotal phase II data underway and plan to submit the BLA in the second half of Bcf, we are poised to deliver help to patient population with no alternative.

And drive shareholder value.

Shareholder value, we look forward to communicating further in the coming weeks and months. Thank you again for joining us.

Yes.

Ladies and gentlemen, this concludes today's conference call. Thank you for joining you may now disconnect.