Q1 2023 Precigen Inc Earnings Call
[music].
Good morning, and welcome to the precision first quarter of 2023 financial results and business update call.
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I would now like to turn the conference over to Steve Harrison Vice President of Investor Relations. Please go ahead.
Yeah.
Thank you Ryan and thank you to everyone joining us this morning.
With me today are Dr. Helen <unk>, President and CEO presaging as well as Harry May see and our CFO .
Helen will provide an update on the progress we have made across our pipeline programs and highlight our upcoming milestones after which Terry will review, our first quarter 2023 financial results.
Following our prepared remarks, we will open the call to Q&A.
Before we begin I'd like to 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 from those indicated by our forward looking statements. Please read the safe Harbor statement as well as <unk>.
Risk factors contained in precedent and most recent SEC filings for a more complete discussion of the risks and uncertainties.
I would now like to turn the call over to doctors Salisbury, Alan Thanks to Steve and thanks to all of you for joining US today before I provide an update on our lead clinical programs I want to emphasize the four clinical principles that are the foundation of our approach to innovating therapies that have the potential.
To transform patient care and outcomes.
First we focus on indications that have high unmet need and four weeks new therapeutic approaches are urgently needed.
Second we strive to develop therapies that are differentiated not only by the clinical benefit they provide but also by their potentially disruptive prices.
A key limitation of many recent breakthrough therapies, especially those in the cell and gene therapies spaces is pricing that can create a significant barriers to access and impose substantial financial burden on health systems and payers.
We are committed to innovating not only new treatment modalities, but also novel modes of manufacture and delivery designed to enable more cost effective pricing.
Third.
We pursue programs that we believe have potentially rapid paths to commercialization.
This approach allows us to address unmet patient needs as rapidly as possible and moves us more quickly to generating product revenues that will build long term value for our shareholders and sustain our ability to advance and expand our pipeline.
And finally, we are committed to executing a cost effective R&D model and maintaining fiscal discipline as Harry will review later in the call. We currently have capital runway into late 'twenty 'twenty, four which we anticipate will allow us to continue demonstrating.
Important progress across our clinical development portfolio.
Now I'd like to provide you with highlights of our portfolio.
Chapter what we have accomplished in the first quarter of D. C S.
The first platform that I will be discussing is adding the west platform and I'm sure. Many of our audience are familiar with this platform. This is a unique and differentiated.
What form that uses gorilla adenovirus that we have a full IP around this.
And basically these unique gorilla Baxter allows first or what have you and introduce a large payload capacity, meaning you can put many genes up to 12 Kb. Many epitopes that can be combined and these back.
<unk> can deliver.
Secondly, and very importantly, as far as differentiation is concerned with other platforms such as at five retroviruses Lentivirus is is the ability.
Complete the re dosing.
And as a result of that enhancing the immune system.
Finally recommend if you have not seen the video of these platform. Please go to our website and take a look at this.
The way. These platform works is actually educate your own immune system directly from within <unk>.
By giving these therapeutic drugs you can enhance the T cell responses, while you are keeping the neutralizing antibodies.
<unk>, which makes these platform very unique and differentiated from all others.
Well utilization of these platform what we have done is brought to drug product. The first one that that would be addressing is our pier G. N 2012.
In the January of this year, we showed a complete phase one and the expansion data for our PR Jan 2012 P. R. G in 2012.
It's a gorilla adenovirus that contains epitope the educating the immune system to HPV, six and 11, which is the cause of basically generation of hockey Longmont in a patient population, which we refer to as recurrent respiratory.
Papilloma.
The disease in these patients these patients.
They continuously have the regeneration of these papilloma in the vocal cords and also in trachea. There is currently no therapies for this rare disease and the only thing that can be done for this patient population is repeated surgery and some of these patients.
A quiet hundreds of surgeries over their lifetime.
The way that Pier G. In 2012 works is a vaccination with of course, a for vaccination that with the data that we presented first of all yes, very favorable safety data, we have not seen any kind of D L Ts and nothing.
More than grade one and two very similar to flu like symptoms when they receive it subcutaneously, but at the same token what we have shown in the data presentation in our R&D day on January was in.
The severe patient population.
50% complete responses.
They're 12 months of follow up these patients did not require any surgery in 12 months follow up what are some of them had up to seven or eight surgeries per year.
At the same token, it's very favorable safety profile and in conjunction we showed and mechanism of action data that after the vaccination. How you have enhanced the T cells that corresponds exactly to this response rate. So we are very excited about it.
We have communicated we are in very productive discussions with the FDA and this is continuing and we are committed to in the upcoming months.
Sure the results, but at the same token I like to highlight in the recent months I'm sure.
Our shareholders have seen their communications that is coming from the F. D. A especially in regards to the rare diseases, which are our P is one and the new guidance is given and the attention of F. D. A forthcoming for a fast solutions and approve.
Walls are for these drugs. So we are very very excited and we are looking forward to communications in the upcoming months with all shareholders in regards to Piacente 2012.
And no other drug products that it's in that clinical.
Trials currently using the same and I didn't know west platform is our pier G in 2009.
The beginning of this year, we communicated that we will be sharing data on the food phase one and combination cohorts all with the checkpoint inhibitors.
With PR Jen.
Tons of nine in HPV related cancer patients.
<unk> 2009 targets HPV 16, and 18, which is the major cause.
All HPV related cancer indications, such as cervical cancer head and neck, Ano and others. The totally 5% of all cancers in the world is actually H P V related huge patient population in need and a huge market for it.
Addressing this.
And to that if you look at what currently is available to this patient at cervical cancer.
<unk> percent response rates on the secondary lines is the best that checkpoint inhibitors have achieved on our head and neck is 18%. So you can understand the need for coming up with their innovative therapies, which we believe P. O. Jan 2009 is one.
And we are really excited about the data that will be presented in a stage four patient population and this is all comers boats I recall cancer head and neck cancers and that data that will be presented and one thing that I should stress. These are patients that they.
Have failed all other therapies, including checkpoint inhibitors.
Now the data that will be presented at the Azgul will not only cover the safety and the dose response, but also the.
Preliminary clinical efficacy that we are excited and our investigators will be sharing that at the high school. So I would encourage you to look for that.
The same token what we have done is position pier G. In 2009 and move it into frontline therapy in the new adjuvant setting.
We all know how important it is for these therapies to move to the front lines and in our phase. Two study that is currently ongoing we have two arms in the new adjuvant head and neck therapy that pier G. In 2009 is actually position in front of that.
The standard of care and this is very exciting we have finished the monotherapy arm of this and I'm excited to tell you that at combination therapy with two charge that will be starting in the upcoming months.
And that will address the patient population that basically would receive a drug products.
<unk> to the standard of care and then they will be followed up and especially for the enhancement of immune.
Responses, which is very very important in this setting so that would be we would be reporting at the interim data by the end of this year as we have promised on PR Jan 2009, and I think this is quite an exciting program that addresses not only the latest stages.
But also it addresses that early onset of the disease, so with that I like to move to our ultra car platform and give you an overview of what we have done.
As you all know our ultra car platform is a unique and differentiated from all other classical car T. C. Ours in the fact that you actually can modified autologous T cells of the patient overnight and this is we believe it's the.
Only truly overnight platform.
Have you modified the T cells of the patient and the next day, you infuse them back.
We currently have.
Actually three clinical trials that are ongoing the first one is our PR Gen 3006.
This is the old truck cod that address it in the AML patient population.
Target CD 33, it includes membrane bound IL 15, as well as the kill switch.
And this is in a patient population that truly there is not anything left these patients have failed all other therapies with a very very limited time, which conventional car ts or other cell and gene therapy will not even have enough time for the manufacturing for these patients.
At Ash, we reported not only on the safety if favorable very favorable safety of our ultra car T. But also the preliminary data from our phase one and the expansion there.
Of that arm that we almost showed 30% objective responses in patients that they have failed all the other lines prior year and we showed not only at the T. Also called 10 expand and persist in these patients but can be effective against the tumor.
And the patients.
Currently on the multiple sites, we are expanding to a phase one b. The F. D. A has not only given us the unmet.
Orphan drug disease designation, but also a fast track designation.
And also the ability to re dose now in this patient and why is that important because we believe this is the only.
Old truck card platform that needed a cost effective manner overnight manufacturing you can read those to patients as they need it over the period of time, we are keeping the costs at Bay and this is very very important for the field of cell and gene therapy.
Yeah.
As we have promised we will be presenting data in 'twenty 'twenty four on our phase one b expansion cohorts and we look forward to that.
In regard to our next ultra car platform is our PR Gen 3005.
Which directly targets much 16 on the ovarian cancer. It also includes membrane bound IL 15, and they kill switch and as you recall, we had two arms in this trial, both intra paratonia al and I V.
The FDA also allowed us to open that lymphoid depletion arm. We have finished the dosing and all the data as promised in early January will be presented at a school and we are excited about this because not only we show the mechanism of action of these that day.
Can these ultra class can expand persist in these patients.
But also a preliminary efficacy data.
And with that we also have moved from phase one b expansion, which that the data will be presented in 'twenty 'twenty four but also one other aspect that is very important based on the data that will be presented.
As though we have added an additional arm that would be a split dosing in the expansion cohort that it wouldnt patients will receive both IV and IP based on the safety and the efficacy that you will see a basketball and this is <unk>.
To be very very exciting and in the upcoming months, we will start this arm.
Arm as well in our expansion phase and we will be reporting on that in 'twenty 'twenty four.
So please make sure that you go to the ESCO poster and taken a look at the data that will be presented by our investigators.
Dan.
Car Ultra car T that I would like to touch base on is our PR Gen 3007, and PR. Gen 3007, it's what we referred to as the next generation of our cost what do we mean by that is simple.
It has become evident that caused in general and now a lot of people are moving in conjunction with combination with other therapies, especially checkpoint inhibitor and you can imagine from that perspective, you're adding the systemic toxicity of a checkpoint inhibitor that has to be event.
But also the cost of that which already it's quite tremendous when you use a classical car Ts in our.
Next generation setup, what we have done is design, our ultra pod that not only expresses the car of interest in this case Rogue one which is expressed on both hematological and solid tumors, but also.
It has membrane bound IL 15 kill switch and the intrinsic mechanism that expresses <unk>.
Downregulates the checkpoint inhibitor. So it basically makes it irrelevant for the use all systemic checkpoint inhibitors and obviously the cost of that we are excited and we have a as you have seen with the press released the first patient.
Was dose in this quarter.
And that and patients are being enrolled as we speak in this trial, we will be having an interim.
Data presented by the end of this year as we have put that as part of our goals and one of the most important parts of this with PR Jan 3007, as I mentioned not only it will be addressing a hematological disease.
Diseases, such as C. L L.
D C L as well as the solid tumors, such as triple negative breast cancers, and this is the umbrella trial.
And this has brought US one step closer to our vision of having a library of ultra cars that can be basically made for various indication overnight as it's needed for the patient.
And finally, what I like to stress after all <unk> 3007 is regaining the rights for CD 19, NBC M. A C.
Very excited about that.
For various reasons number one these are validated targets.
That already.
Has shown that they can be very effective in these indications.
At the same token now we have shown that our platform all ultra car Ultra parade or platform now we have validated this across various indications both in hematological and solid tumors.
And the combination of these two we believe will offer them.
It changed the paradigm for patients for treatment for the cost for their ability to be read those and this is quite exciting with the having both under the same roof and our teams at the precedent has been moving forward rapidly.
And our aim is to be phase one ready by the end of this year for CD 19, and then we will address also be CMA. So from that perspective, we are excited that we can take these drug.
Drug products to the market. The most important thing is we are aware that there are approved drugs currently in classical car tease out there.
These are the first in a class, but sometimes being a best in the class. That's what is important not only for the patient, but also as far as taking the portion of the market and we believe between our platform and the validity of the targets we have.
Very good path forward to be best in their class.
And with that this is why we are excited and moving these programs very rapidly at the same token at part of regaining the rights for our CD 19 and be CMA. We also regained the rights for IL, 12, and especially our gorilla IL.
12 pack with a control sewage and why is that important in the past decades. The role of IL 12 has always been considered as one of the best molecules.
For enhancement of immune responses and in combination. However, the biggest issue has always been the control for IL 12, and we are we believe the only company who has now the highest amount of clinical data with the control switch with IL 12.
This makes it very unique and absolutely very appropriate for our portfolio, especially in combination with our current molecules for the future why I'm, saying that in the recent data that have been shown across various indication, but it's specifically has done that.
The role of IL 12 has become often center and now we have one of the most potent molecule under the same roof with our portfolio. We are excited about that and we will be discussing this in the upcoming.
In a month and a half of the year so with that.
I would like now to transfer to hurry to address are.
Financial reports Harry Thanks, Alan.
And good morning to all of you on the call.
Appreciate your participation in our quarterly update.
During the first quarter, we've continued to make progress on strengthening our financial footing, while containing costs to support our business objectives I want to spend a few minutes updating you on the progress we continue to make from a financial perspective.
I'll start with an update on our convertible notes during the first quarter, we repurchased an additional $29 $5 million.
All U of convertible notes at a discount to par.
As of March 31, the remaining balance of our convertible notes was $13 8 million, which will be paid at or before maturity on July one of this year.
We will continue to utilize our restricted cash balance and the retirement of these securities.
To date, we've retired $186 $2 million face value of our original $200 million of convertible notes prior to maturity, which has saved the company close to $7 million.
Secondly, when I started the prestigious <unk> approximately a year and a half ago, we set a goal to reduce our G&A spend since that time through a focus on efficiencies as well as settlement or progress towards settlement of older litigation matters. We believe that we have right sized our G&A.
Function costs I am pleased to announce that our G&A expense was decreased by 15% in the first quarter of this year compared to the same period last year.
We believe that our first quarter G&A spend approximates what we anticipate for the remaining quarters. This year.
You'll also see in our reported financial information, our research and development costs have increased in comparison to the prior year quarter.
With the reduction in interest and G&A costs, we've been able to redirect our capital towards our mission of drug discovery. We expect this trend to continue with further advancement of our product candidates.
Turning to our cash burn our net cash used in operations for the current quarter was $18 $4 million versus $18 $8 million in the year ago quarter.
Our cash burn was positively impacted by a reduced G&A and interest costs. These costs more than offset the positive cash flow in last year's first quarter of approximately $2 million from our previously owned Trans Ova business prior to its sale in the third quarter of 2022.
In addition, we were able to increase our R&D spend while still reducing our burn for the current quarter compared to the first quarter of 2022.
In summary, our program of financial discipline combined with our public equity offering in January and the early retirement of our debt has provided a solid cash runway to support our priorities into late 2024. This is consistent with our previously provided guidance on our cash.
Cash runway.
Thank you for your support of pressing Jim will now be happy to take your questions.
Ryan you could luck questions come in from acute that'd be great.
Yeah.
Thank you.
We'll now begin the question.
Answer session to <unk>.
Ask a question.
Star then one on the telephone keypad.
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Yeah.
Our first question comes from Jason Butler with JMP Securities. Please go ahead.
Alright, Thanks for taking my questions and congrats on the progress.
Two from me the first one on power Gen 2009, and can you give us some more details on the data youre going to present it as go.
Will we see data from all enrolled patients here or a subset and how should we think about the duration of follow up and then secondly.
For <unk> 3007, <unk>, how long can you maybe just give us some color on the mechanistic rationale for rural one in solid tumors. Thank you.
So thank you Jason.
For the questions.
Lastly in regards to Pee our Gen 2009, there will be a full data are in.
Presentation on the phase one and also the expansion cohorts and four with a checkpoint inhibitor.
That not only on the safety the mechanism of action and some of the scientific mechanism of action will be also presented and the efficacy and to the point I'm glad you brought that up but I think what is very exciting not only are there.
There will be presentation on that objective responses, which is unique as I mentioned this patient population in a best case scenarios, we have 15% response rate up to 18 in head and neck and this is by the way there will be patients both cervical as well as head and neck in.
That cohorts that will be presented.
But also and we showed that in majority of in a combination arm in patient population that they have failed checkpoint inhibitor and then when we add <unk> in 2009 to the checkpoint inhibitor in the same patient population that they have a stop.
Responding to checkpoint inhibitors, then we will show their responses and to the point that you raised I think part of the other part of the excitement here is the durability of the responses, which are investigators will be addressing and presenting on a patient basis.
In regard to <unk> 3007 <unk>.
I think this is really an exciting target because the roller one is expressed on.
Hematological as well as solid tumor there is actually a range and that it covers and currently the way the trial is designed.
You can have not number of patients from various hematological settings, such as C. L. L. D. C. L. A L. L. And then at the same token the triple negative and especially the triple negative because this is an area I unmet need for these patients as you know there are really truly.
<unk> therapies.
Out there for patients that they have failed everything and no car to my knowledge really classical car T programs or any other T cell therapies at this point for this patient. So it makes it unique and the reason food did design is.
We know cars.
C. R piece all of these at the end of the day. They are T cells, and therefore, they would be subjected to the tumor micro environment and part of the issues of the tumor microenvironment is the inhibition of the T cell to the checkpoint inhibition.
And as a result that needs to be address a lot of the off the shelf.
Conventional cars they are now entering and addressing that they need to combine with the checkpoint inhibitors for number of reasons because first of all they only have one shot they cannot read those so that's the issue.
And secondly, they have to overcome this a tumor microenvironment.
So with US we have design and our ultra vectors allows us to incorporate mechanism that we can directly inhibit their checkpoint inhibitor just within our ultra car T. Why is that important because there is no systemic toxicity.
Or there is no signal to others. So it's just your own ultra car T that will stay active.
And you don't need now to add for instance, katana any further you get away from that is.
Systemic toxicity, but also more importantly from a $150000 price tag that has to be added to another $400000 price stack all the conventional car T. So as a result of that we think this is very unique and the platform that we have allows the addition.
Of this at the same token it makes the combination irrelevant and that's why it's very exciting what is happening right now.
Great I appreciate all the details are Helen thank you.
Yeah.
Thank you.
Question comes from Dennis Kim from Cantor Fitzgerald. Please go ahead.
Hey, everyone. Good morning, and congrats on the quarter I have a few questions here maybe to start with a 3007 I think I heard in your comments that you plan to present, some interim data this year and I'm wondering since it is an umbrella trial is there anything in terms of what you'd flag.
And what you'd want to see in that initial look are there certain tumor types that you're interested in solid tumor versus team et cetera.
Then my second question.
Is I think you also mentioned it for three or five something on this.
Pursuing split dosing could you go more into detail on what that entailed and sort of the implications of that thanks, yeah, absolutely. Thanks, Jeff. So in regards to the peer January thousands of them, maybe I should've just sort.
Sort of makes.
It makes that more clear.
Currently we are in a phase one and what we said that we will be perhaps by the end of the year.
Some of you on.
Doses that will be completed the full databases for phase one and the expansion cohorts, we will be addressing in 2024 by the end of the this year, we will give some color from perspective of how the phase one is going on some of maybe it is.
Sort of a preliminary database.
So that's in regard to the Pea Adrienne and 3007 as far as the data is growing because we've just started and of course, we want to give them more of a complete set of the data, but definitely we will be discussing we use our know how.
The trial is going on in some some preliminary we will not be finishing the phase one completely dcs this wouldn't be a buy and all presented by next year in regards to their P. I G N.
And then 3005 and they're split dosing.
And this is very interesting because the data that will be presented are in there are optical and because of the embargoes, we cannot be going to the details right now that we have from <unk>, but this will be presented by our investigators you will see.
A very unique mechanisms and that vote and it exists in when you gave the intraperitoneal the drug versus when you gave the I V.
And also from the perspective of when you add the lymphoid depletion.
And now after observing and this is why it was so important that we do two arms and by the way.
It's really points out in regard to our ultra car how expansion persistence works.
And without lymph with depletion.
Also the route of infusion makes a difference but also on top of that how they are and what you see on the preliminary efficacy data and as a result of that not only we have gone to the phase one b already and we have the odd.
Armed with the I V.
And lymphoid depletion open as you know we also received the permission from the F. D. A to read those and that is going to be exciting and data will be presented at Astro in regards to that.
But also now based on the totality of the data we can see that what else can be done and that split dosing. It's actually these are all at stage four by the way patient population, whereas <unk> cancer, so ovarian cancer.
10% response rate and nothing has moved that needle for this patient population nothing and the upcoming.
And they and.
And with that what we are doing is the same patient because of the ability of our ultra car platform that you can make number of doses and even make a large enough dose that you can split.
And the patient can receive a dose that is infuse intra paratonia Ali because many of these patients as you can imagine the surgeons cannot remove the totality of the tumor that easily then that intra peritoneal cavity. So you need to address.
That but at the same token you need to address them the desk that says that it's around the body.
And so the IV dose.
The intraperitoneal dose the patient would receive thesis split dosing and Thats. The design and we are looking forward to this.
This will be the starting in the next few months and we will be.
Discussing that which we're very excited.
Okay, great. Thanks, Colin maybe one more question on the 20th Eagle asset.
Any updates on the timing of FDA discussions and can you remind us on the possible outcomes in strategy that you're pursuing for 2012.
Yeah.
So one thing or PR Gen 2012, what I should mention is really the work that has been done has been outstanding because I just wanted to remind everyone. The phase one of this started in April of 2021.
Not only are reported on the full phase one data and the expansion dose cohort in January of 2023, but we had to start the phase two day basically clinical trial in 2022, and I want to stress if I buy any.
I forgot and it's in the press release today that we have finished the phase two enrollment and now we are in the 12 months follow up of those patients which is very exciting. So you can see how rapidly our teams have moved not only to get the phase one.
Now half the 23 patients in our phase two so the total 35 patients that has received the dose level two in the phase two and we are really excited about that in regards to the interactions with the FDA. We are in that continuous discussions I'm very productive discussion.
Of course.
Our communication with them.
The complete answer so we are in discussions is very productive and as especially in the view that.
What Dr marks has been mentioning in the past few months in regards to the new guidance is and changes at all that and how the rare diseases, especially are being treated.
It faster and more innovative guidance says that allows it safe.
And efficacious drug products to basically.
B advance for the unmet needs of the patient we're very encouraged by this.
And and it's exactly where our discussions are with.
With the FDA. So as we have mentioned we will be communicating as soon as we have the finalization of this strategy by the F D. A.
However, we have to respect the timelines of the SBA at this point and and confidentiality of their discussion so the.
What I say is please stay tuned I think it's gonna be exciting year for us.
Awesome, Thanks, Alan and congrats again.
Okay.
Thank you our next.
Next question comes from Ben Burnett from Stifel. Please go ahead.
Hello. Good morning, this is catalina.
So for the pain.
Congratulations on all the progress.
Thank you for taking our questions.
Follow up on the Pier again, 2012 filled it out and Ive seen that like you said.
In your prepared remarks that you plan to percent I'd be shocked yourself in a few months.
If you could confirm that and then what can we expect in terms of number of patients out of the 35.
Whoa.
Follow up time.
In this update on I think.
You are going to wait.
<unk>, 2% pre sold.
Hum a clear FDA feedback or.
We may see some data before that.
Yes, and thanks, Scott for the or the crush.
Question first of all in regards to the <unk> 2012, there would be no further the presentation of the data we presented the full phase one and the expansion cohorts.
Phase one in January and the totality of it actually patient by patient and it's a very solid safety as we have shown.
As well as a complete responses 50% responses.
So the next basically a data presentation of course will be in the context of the phase two and when they have finished their food follow up of that as I mentioned, we are excited we have finished the enrollment of the 23 patients in our <unk>.
Phase two.
It's and obviously they have been and they are being followed.
From the first patient to the last patients there will be a follow up of 12 months and complete and the discussions that we have with the FDA obviously is in.
In their view of safety.
Data, which as I mentioned and all the investigators have pointed out. This is the safety that has been shown is extremely favorable.
It's almost like a flu shots, but just some rash reaction at the site of the injection sub Q and maybe a little bit of a fever.
And aches for a day or two but nothing more than that and in view of.
The efficacy data, which is very unique when you talked about not just reducing the number of surgery, which in a the more than 83% of our patients that happened.
But actually eliminating a requirement for surgery in 50% of patients and by the way the uniqueness of the patient population that we have.
Enrolled is that we have gone after the most severe patient population. These are patients that they have required minimum required three surgeries per year and majority of them have a much more so with that.
From the perspective of the FDA of course, there is discussions that what does the pivotal trial looks like or if what we are addressing currently at can be considered that.
The endpoints, which is of course ours and we have made them extremely robust. We didnt go just after the number of reduction in the surgery, but we haven't gone to the endpoint.
Complete.
Bonds, which no requirement for surgery and for 12 months. So the durability is also very important.
And of course.
Rapid part.
For the approval. These are the discussions that we're having with the FDA and are in a view that this is a rare disease patient population that they have no other options in front of them, except continuous surgery and also in view of the current guy.
<unk> that is coming out and changes and that has been communicated.
By SBA leadership, we're excited and we're continuing this discussions and of course as I mentioned again, the confidentiality we need to respect the confidentiality and discussions that we have with the FCA and as soon as we have some place.
Our strategy approved we will be communicating that to death.
Yeah understood very helpful.
I may.
I've got another follow up question related to this program.
In light of folding it feels like you have a good.
So far what is your expectation for the need of a video for example, blah blah booster.
With me is with your vaccine.
Yes. So excellent question currently the way our file has been is one course, which is for vaccination.
And that's all these patients have received definitely there will be a follow on and and trials that will address boosting because with the view of the safety that this platform and the P. O Jan 2012 has definitely.
It can be imagined that in the patients that they didn't reduce it completely their requirement for a surgery that will be an option for this patient population definitely and of course, another part of the strategy and the path to work there.
Commercialization will be also that we have to address their pediatric patient population with currently that's not part of this trial and that would be also in the future as we will be addressing that patient population and market. So for sure those are within the.
Works.
Yeah.
Okay excellent. Thank you very much put all of the color sure.
Of course.
Thank you our next.
Next question comes from the line of alcohol.
From H C. Wainwright. Please go ahead.
Yeah.
Hey, good morning, Alan.
Sorry.
Oh, okay.
I have two questions.
It's for the.
Oh five and.
And.
And then repeating dosing.
Could you remind us how the repeating dosing can be.
In terms of the.
Government.
The physician or patient need.
Yeah.
I had a follow up on that part.
Sure. Thanks, Harsha, so in regards to the repeat dosing.
Forrest Li for the expansion phase is at the discretion of the physician and why it.
Is that.
First of all in regards to 3006, we are dealing with a patient population that they have few months. Unfortunately to lift and I think this is definitely we are getting a mixed patient population with a different requirement we.
We have had patients that they have came out of the hospice to receive these treatment. So you can imagine.
How sick their patients have been so based on that and the need and the extent of the disease or the stability of the disease.
The best.
George at this moment are the clinicians and their oncologists that they can make that call instead of having a regimented that we say well every four months because of patient might not have four months in general and they might need a faster or much more.
Grass seeds upfront then on the other hand, there might be patients that their diseases are stable and then they might not require immediately and this is why the patient or if the clinicians they see assigns and early signs of progression they can intervene.
Accordingly, so that's why currently the phase one b, which is an investigation of design is to understand the course of the disease and the need and also the.
The amount of for instance in various patients with this hum.
The level of this is what is required and the same thing goes for PR Gen 3005, because again.
I'm going to stress one thing of course, the goal of all of that.
Therapeutic drug is eventually to move from stage, four and we will be able to bring it in two different lines that.
In reality, we don't.
Allow the patients to get to a stage four we need to stop the disease much earlier.
But because these are investigational drug of course, we have to have thought for a safety perspective in the states for us and where we are going with all of this and then also our PR Jan 3005, the ovarian cancer is the same thing you have.
And as it will be presented at the high School you will see we have patients that they have fell seven eight line of therapies.
So with that in mind, you can imagine that the requirements of those patients are different adaptation that might have failed two lines of therapy.
And therefore.
What.
We have done is designed it this way as we get the data from phase. One B then we can narrow down further according to this stage of the disease. According to the course of the disease and then we can have a basically a different design for various stages.
Or.
Dosing, but right now what is important is number one we can results. We are the only platform that can do that without.
Tremendous costs.
We can directly expand the cells in the patients and I think the data in our food.
<unk> 3005, <unk> Nasco will show that.
Okay.
Sure Yes.
Follow up on that part so.
For the product is used to be used for the repeated dosing.
So on average.
How many how many doses you can.
Get a wombat.
Production for those yet.
Yeah, I think this or are the of course. This is part of our manufacturing process, but I can tell you that we can from the material that originally we can get we can produce number of doses as well.
And obviously you can always a freeze again and then if later on.
It needed to be used for more than a number that we have so currently we're basically with the regional material, we have been able to re dose.
Okay.
My last question is.
Is it all day.
Regaining rights to those really 90 N V CMA target.
Could you give us a broad picture of what your strategy to go to target.
Yeah, absolutely so our strategy from the beginning has been really.
We know CD 19 works and everyone has seen that.
Kite and Novartis they have shown that <unk>. Similarly, we know it works.
The issue at hand for the field is.
How do you manufacture this what platform to use and the cost.
And we see that this is a struggle even for the biggest farmers of the world. They are it's a struggle in order to get this to a patient with a price tag that.
Not only few patients can afford this but everybody can have access to this so first thing for US was very important and a lot of people ask the question in regards to Sydney and 19 was to show to our platform.
First of all is scale our platform.
Put it in the clinic make sure that it's safe and make sure that it does what we ask the platform to do it.
Now across multiple targets.
Hematological and solid tumors.
With many patients we have shown this so this is the platform has shown its capability and by the way when we or even on the set that we have changed that.
Sleeping beauty platform and we have not only modify it to fit what a commercially viable scalable platform should be that's exactly what we have done and that I am again to my knowledge no. One else has been able to bring in.
Non wire all platform.
Overnight to this patient so we did that.
Now after doing that across AML ovarian and drilled one positive indications.
What we are no. We can do is to bring the CD 19, NBC them and why it was important for us to regain these assets because we know with application of our platform plus the validity of these targets we can change the paradigm now.
And as I said, it's not about just being first in class or first to market. It's about the best in the class and then how you can affect the market and we believe we can do this now and even though yes. There are drug products out there, but you have seen that.
Availability of this and the costs and we think we can do better and that's why we are very rapidly moving get after showing our platform also has the ability to be a scaled up and commercially viable.
Yeah.
Okay.
Thanks for taking my question and congrats on the sure.
Thank you very much.
Yeah.
Thank you ladies and gentlemen, this concludes our question and answer session.
At this time I would now like to turn the conference back to Dr. <unk> for closing remarks.
Thank you.
As I mentioned this is really a very exciting time for precedent and we are making significant progress in advancing multiple clinical programs.
Each of the five clinical program discussed today meet this foundational clinical principles that I outlined at the start of the call.
Thus, while our GUL pipeline provides multiple shots on goals in a diverse oncology indications and rare diseases with demonstrated unmet need. It is also align with our business strategy and organized to meet our financial discipline objectives.
At this point I would like to sincerely. Thank all of our patients for putting your trust in us and their fate and everyone at precedent for their focus on dedication to our clinical and our strategic objectives, which I'm honored to stand next to them.
And to once again acknowledge our shareholders, whose support is essential to our ongoing progress I look forward to updating you in the months ahead as we make progress towards realizing our vision of developing transformative therapies with disruptive pricing that can improve at comscore.
Patients and the economics of safe and effective cancer therapy. Thank you again.
Thank you the conference of precision has now concluded. Thank you for your participation and you may now disconnect your lines.
Okay.
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Yeah.
Yeah.
Okay.
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