Q3 2022 Iovance Biotherapeutics Inc Earnings Call
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
Okay.
Welcome to the <unk> Biotherapeutics third quarter and year to date 2022 financial results and corporate update conference call. My name is Andrew and I'll be your.
Operator for today's call.
At this time all participants are in a listen only mode.
Later, we will conduct a question and answer session.
During the question and answer session. If you have a question. Please press star one one on your Touchtone phone.
Please note that this conference is being recorded.
I will now turn the call over to Sara Pellegrino Senior Vice President Investor Relations and corporate communications at Io bits, Sarah you may begin.
Thank you operator, good afternoon, and thank you for joining us.
Today's call we have Dr. Fred cope.
Interim President and Chief Executive Officer.
Igor Balinsky, our Chief operating Officer, Jim Ziegler.
Decorative vice President commercial Dr. Frederic <unk>, Chief Medical Officer, and John Martin.
Our Chief Financial Officer Dr.
Dr. <unk> <unk>, our executive Vice President Medical Affairs, and Dr. Raj Perry, our executive Vice President regulatory strategy and translational medicine are available for the Q&A session.
This afternoon, we issued a press release that can be found on our corporate website at <unk> Dot Com, which includes the financial results for the three and nine months ended September 32022, as well as recent corporate updates.
Before we start I would like to remind everyone that statements made during this conference call will include forward looking statements regarding iolanthe cool is that.
Okay.
<unk> pre commercial activities clinical trials and results regulatory interaction Brandon strategies research and preclinical activities.
So future applications of our technology manufacturing capability regulatory feedback and guidance her interaction licenses in collaboration cash position net expense guidance and future update.
Forward looking statements are subject to numerous risks and uncertainties many of which are beyond our control, including the risks and uncertainties described from time to time in our SEC filings.
Our results may differ materially from those projected during today's call.
Undertakes no obligation to publicly update any forward looking.
With that I will turn the call over to Fred.
Thank you Sarah and good afternoon, everyone I.
I am pleased to highlight some great momentum in <unk>.
Getting ready to complete our biologics license application or BLA submission for our lead til therapies like we'll do so.
In advanced melanoma, while preparing for commercialization developing a robust immuno oncology pipeline.
Ill begin todays introduction with a brief status update on the rolling BLA for <unk>, which we initiated in August . This remains our number one priority on behalf of our patients with advanced melanoma, who are eager to see light pollution.
Possible.
Rolling BLA allows us to submit portions of the BLA to the FDA on ongoing basis. So that the FDA may begin review as early as possible as documents or received potentially allowing for earlier approval.
We have continued to meet the submission schedule a pre determined with the FDA and remain on track to complete the BLA submission this quarter.
As a reminder, we previously received positive feedback from the FDA on the potency assay matrix.
We also had a successful pre BLA meeting in July where the FDA provided favorable feedback.
The efficacy data from cohorts, two and four of our <unk> hundred one clinical trial.
So the duration of follow up.
Clinical and <unk>.
The data set was sufficient for a BLA review.
<unk> remains engaged and supportive as we progressed the BLA submission process.
We look forward to continuing this level of collaboration.
For our initial BLA submission.
And the anticipation of potential approval March of light Blue. So next year or commercial readiness activities include medical education treatment Center, Onboarding pair engagement commercial manufacturing readiness and near and long term capacity planning.
Part of our cross functional effort to educate physicians about our clinical data and the on that medical needed advanced melanoma, we are especially excited about the upcoming society for for immunotherapy of cancer <unk> annual meeting next week.
We will present the detailed data from R. C 144 O one trial courts to enforce it for the first time that the medical community in a rapid oral presentation to 12 33 PM Eastern on November 10th.
Earlier today <unk> issued a press release to announce the titles for the annual meeting Press program R. C. 144 O. One abstract was one of only eight abstract slept at a more <unk> more than 1400 total objects to be part of the press conference.
Following the presentation November 10th we will hosted Investor webcast in conference call with key opinion leaders, which will be accessible on our website. We look forward to having a high level of visibility at the meeting encourage everybody on the call today to attendance etsy and or participate in our investor event.
The addition of life loose on melanoma growing until therapy pipeline has potential create significant value for cancer patients.
As well as our shareholders were treating patients and six islands clinical trials across multiple till treatment regimens insult numerous which reticle highlight today's call.
The strength of talent within I advance also reflects tremendous enthusiasm for it until therapies in our glitter global leadership within the field.
We currently have more than 450 employees with deep expertise and successful track record in college.
Cell and gene therapy development and commercialization.
I look forward to addressing your questions later during this call will now ask eager to address manufacturing updates.
Thank you for it.
<unk> continues to prepare O manufacturing network to address patient needs and meet demand. This launch we continued to achieve operational excellence with a consistent pill manufacturing success rate of more than 90% and more than 500 patients treated with <unk> till therapy to date. This <unk>.
<unk> has been consistent across tilman et cetera that our internal facility, the <unk> cell therapy center or pie TTC and our contract manufacturing partners.
We are currently supplying clinical studies from ICC, our custom design 136000 square foot internal manufacturing facility.
The Navy yard consistent with our overall manufacturing success rate the success rate is more than 90% fulfill manufacturer that ICC.
The I C. D. C is operating for like sweets for clinical manufacturing and of course with four BLA readiness activities.
Manufacturing is critical for any commercial launch, particularly fourth August cell therapies. So our top priority is to prepare for commercial supply to meet patient needs.
In addition, we own truck and preparing the icd's seat and our contract manufacturers facility for FDA Preapproval inspections.
CDC is expected to supply most of the commercial till therapies upon approval, while contract manufacturers provide additional flexibility to optimally manage capacity and fully mitigation demand.
Note that in our press release. This afternoon. This includes a recently signed commercial manufacturing and supply agreement for two GMP manufacturing sweets at our contract manufacturing partner.
We're also planning future capacity needs as we look to establish till the next paradigm shifting class of cancer therapies as we have outlined them. Prior calls the ice CDC facility is currency built has annual capacity to supply more than 2000 patients with flexibility to build out existing shelf.
Space to supply more than 5000 patients longer term, we plan to supply more than 10000 patients annually by adding new facilities as well as streamlining and automating manufacturing processes.
Two separate all proprietary manufacturing processes, and Knowhow and to further solidify our leadership until therapy. We are also growing our intellectual property or IP.
We currently own at least 60 granted or allowed us and international patents, including Jen to patent rights that are expected to provide exclusivity into 2038.
I would now like to hand, the cold to Jim Ziegler to highlight are commercial launch preparations Jim.
Thank you Igor.
Our cross functional teams are making steady progress with our lunch priorities from Isoleucyl today, I will highlight the onboarding of our authorized treatment centers or etc's payer engagement and commercial operational readiness activities.
First our teams continue to have structured interactions and work with the leading U S cancer centers to build their tail service line capabilities.
Our goal is to Onboarding trained at least 40 etc's within the first 90 days of launch.
For life Maluso administration.
Atc's can leverage existing workflows within prevalent cell therapy service lines.
And we are facilitating the development of Newark clothes that are unique to <unk>.
Till cell therapy.
Our ATC Onboarding program includes the training curriculum.
That ensures multi <unk> <unk> teams at each center can administer the life maluso treatment regimen upon approval.
The timing and execution of key Onboarding activities and training are aligned to our regulatory milestones to insure just in time training and readiness.
To support timely patient access and appropriate reimbursement for a life of Leucyl upon approval or market access team continues to engage with national and regional payers.
We are pleased at the centers for Medicare and Medicaid services are CMS continues to recognize novel cell therapies, including like Maluso in the expanded M. S. D. R. G 0184 Medicare patients.
Mapping life will loose alter DRG 18 ensures that more appropriate payment is available at launch for hospitals treating Medicare patients.
In closing I wanted to acknowledge our core cross functional teams and continuing to build a strong foundation for life of Leucyl commercialization.
We are well positioned to scale our efforts heading into launch.
I will now pass the calls are Friedrich Frankenstein, our Chief Medical officer to highlight are clinical progress.
Thank you Jim.
Today, I would like to summarize our till therapy pipeline of next generation technologies to address more cancer patients new tumor types at various stages of disease.
First as Fred mentioned, we are looking forward to an oral presentation at F T.
Next week. The presentation will include detailed clinical data from 153 patients across cohorts, two and four and the C 14401 trial and advanced melanoma.
This is the largest single clinical study ever conducted for self therapy and post ICI melanoma.
As a reminder, the top line analysis fill the child was previously announced and has been summarized on our prior industrial calls an investor confidence.
The pivotal caught four met the pre specified primary endpoint, which was objective response rate or are assessed by independent review comedy or IRC.
The endpoint.
<unk> has been the basis for FDA approval of many cancer agents single studies.
In addition, we previously provided various results for secondary endpoints and supportive measures of durability, four cohorts too and for that represent meaningful improvement over available care for a clinical trial population.
As we've said previously FDA has given us positive feedback on the clinical data four chords foreign too and that cohort too may be supportive of approval.
The caller to a safety data and the efficacy data a part of the BLA submission and potentially the label for life.
Approved.
We are confident in the potential for approval and advanced melanoma on or after anti Ped, one therapy, where there are no FDA approved treatment options.
For patients and physicians.
See what our medical meeting to present the C 14401 cohort for data and the pools analysis of cohort two and four to the medical community.
Feedback from key opinion leaders, who have seen the comprehensive data across the full spectrum of patients and cohorts to enforce with post anti ped, one melanoma has been very enthusiastic for.
For the medical community.
<unk>, we will focus on a detailed pooled analysis of courts to enforce this approach if appropriate because patients in both courts, two and four met the same primary edits ability criteria at the same study assessments and received the same treatment regimen and life would lose so that was produced using the same 10 to cry.
Preserves till manufacturing process.
Together, the two cohorts a representative of the real World advanced melanoma patient population.
The content of the presentation under embargo, but you can expect the level of detail in line with our prior cohort two presentations had prior medical meetings.
We are confident that the <unk> presentation will add to the positive topline results that we previously shared as well as a comprehensive and relevant data set support of adoption of bipolar for an advanced melanoma patients.
To recap the progress with our pipeline we continued to develop till in combination with temperature is a map and checkpoints that are naive patients with various tumor types to expand upon the initial opportunity for life Leucyl monotherapy after anti Ped, one therapy, where.
We are committed to starting a phase III study in frontline melanoma. Later this year, which is also designed to serve as a confirmatory study for a potential accelerated approval of DNA submissions for life Leucyl.
We are also excited about initiating the first clinical trial of our efforts genetically modified P. D. One and activate it till therapy candidates ILP for thousands one we're making great progress in the I O B G. M. One tool one first and human study to assess safety and <unk>.
Central for increased potency from the genetic modification in Iowa 4001.
During the third quarter, we treated the first patient with Iowa, 4001, and continued to recruit patients with previously treated advanced melanoma or non small cell lung cancer.
Preclinical data supporting the rationale for I will be 4001 and trial in progress updates have been presented at several medical meetings and are available on our corporate website, we plan to share at trial in progress pollster on GM, one two O one.
C to further educate the medical community about 4001 as a potential options for the patient.
We also continue to prioritize our non smartphone lung cancer pipeline is Iowa.
We have multiple shots on goal with a total of six school. It's across the <unk> study is not enrolling patients at various stages of disease and using multiple treatment regimens.
And cervical cancer, we haven't expanded our ongoing C 14504 study to enroll additional cohort two patients.
Who are too is intended to be pivotal to support regulatory submissions for the treatment of cervical cancer after chemotherapy immune checkpoint individual therapy.
Looking towards next generation kill therapy approaches, we have a robust research pipeline advancing towards the clinic.
Following the progress of I always thought the other one into the clinic additional research in preclinical studies focused on optimizing till therapy consists of several targets for genetic modification using the gene editing talent technology, including doubled genetic knockout program.
We are also exploring approach to increase killed potency using CD 39, 69 double negative till and Jean knock in targets that incorporate other enhancements such as tethered cytokine.
Hi, Andy enabling studies also continue for her novel interleukin two analogue <unk> 3001.
I am available during the question and answer session for now I will have to call over to soar Mark to discuss our third quarter and year to date 2022 financial results.
Thank you.
My comments will reflect the army row financial results of third quarter in Europe 2022.
More details can be found in this afternoon spruce release as well as in their OCC filings.
How are we doing with an overview of our cash position.
September 14th 2000 Princess too.
$366.
$6 million in cash cash equivalents investments and restrict discuss.
Compared to $602 1 million girls on December 5th two crews Princess once in a while.
<unk> oncology conference approaching potential commercialization, we continued to make province investments and commercial loans preparation.
Phone number <unk>.
Moving to the income statement.
For the third quarter on good September 14th 2000 2001.
$99.6 million or 60.
63 cents.
Those.
This compared to net loss of $6.1 million.
<unk> for the first quarter on September 30th towards the towards the wall.
No class for the nine months I'm Gonna September frozen towards your purchase.
Was 200 mile $2.6 million or one girl I mean, five cents per share compared to a net loss of $242.9 million or one.
One dollar and 60 cents per share.
Rosemary and most of 2021.
Research and development expenses World $72.5 million for the third quarter on September 14th 2002 thousand.
An increase of $7.1 million compared to $65.4 million <unk>.
Research and development expenses were $214.2 million for the nine months.
<unk> and.
An increase of $32.8 million compared to one <unk> $3.4 million <unk>.
The improvement of research and development expenses over the prior year three nine months.
Was primarily attributable to the growth <unk> research and development team.
<unk> compensation expense.
Support ongoing and planned pipeline activities as well as increased questions you reduce or the internal research program costs.
This iron cross will partially offset by lone worker Nikola manufacturing costs in the first nine months of <unk>.
Driven by completion of enrollment and futile clinical trials.
For a moment I'm intrusive expenses were a princess $7.9 million for the third quarter and the September 30th 20, <unk> and.
And then Cruz, a $7 million compared to 24 $99 for the same period.
September 1st and towards the principle.
So none of administrative expenses were 727 $6 million for the nine months after September purchase purchase.
And then cruz of $17 <unk> compared to $59.
For the same period for February 14th 2021.
<unk>, an order of administrative expenses compared to the prior prior here three nine months burgers were primarily attributable to the growth of the internal janella memory.
Infomercial teams, including stock based compensation expense as well as costs associated with the <unk> of the new <unk>.
Commercialization Mexicans.
As of September 30th 2022.
Approximately $167.8 million commensurate those standards.
With the cash position that continues to support our prisons investments and commercial property insurance.
Manufacturing and pipeline expenditure.
We are well positioned through the <unk> plan into commercial launch and beyond.
Are now and the call back to <unk> to keep up with you on this issue.
Thank you.
As a reminder, ladies and gentlemen to ask a question you will need to press star one more one on your telephone.
Once again to ask a question. Please press star one one.
One moment please.
Our first question comes from the lineup Michael E with Jeffries.
Hi, Good afternoon. This is Jenna on farm Michael Thanks for taking our questions two questions from US one what incremental Kentucky, you expect to put some extra cheese would you be able to smell follow up what you're satisfied between <unk> second question what are we discussing with <unk>.
For a long time Sir.
Back to you are able to share with us.
Alright, that's all can still are at one time, we hear more about this.
Yeah.
Yeah. Thanks. The data is cincy will include detailed data on full cohorts two and four.
There will be some individual covered two and four data as part of that.
You can look at it as part of the presentation.
[noise] mentioned gratification is not going to be stratification micro worker.
Together and are analyzed data assessment separately in some cases.
Highlight some of the differences and similarities of data.
Regarding esca and not smell, so long, we haven't providing updates on that yet and hopefully can do the near future.
Got it thank you.
Thank you.
No. Our next question comes from the line of Tyler Van Buren with Cowans.
Hey, guys. Thanks, very much for the updates just a follow up on the sixth presentation will the correlation between duration of response in prior P. D. One treatment shown very clearly.
With a cohort for patients in the presentation and can we they expect the patient level of detail by swiftly and plot.
Ah, Yes, hi, Laura Eoc's patient level details homeland plots.
Correlations there'll be an analysis suits.
Everything that we could we could include in the presentation remember that we've.
We also want to stress the importance at all age levels and patients as well as to refer to disease burden across patients to it.
Stress at our recent disclosures on this topic <unk>, you'll see some of that in the presentation as well.
Great. Thank you.
Thank you.
And our next question comes from the lineup Colleen Q C. R. W Bear.
[noise] hi, good afternoon. Thanks for taking our questions could you comment what items are still outstanding to completing that Rowling D. L. A and do you have any sense. If the F. D. A has already started reviewing some of the data that you've already submitted.
Yeah, calling they're.
They've been very responsive so it's possible that we're getting the data, but they don't really provide that sort of updates or enrolling submission. We haven't disclosed the details exactly where we are in the rolling VLA, what we submit it and we will be having submitted but I can tell you that we've made substantial progress won't notice and we're still on our timeline related in the fourth quarter.
Okay. That's helpful. Thank you and I understand I C. T C. As bill today has capacity for about 2000 patients Uhm. When did you expect the capacity to be at lunch and and kind of what drove the decision to sign the new agreements with the contract manufacturers.
Ego or would you like to take that one.
[noise] happy to thank thanks for the questions. So we're not disclosing the exact capacity and <unk> to have the capacity to satisfy demand and we're not commenting on the on the executive Spectation for demand, but the general plan is to have full capacity to mutation demand his lunch.
Ah regarding our agreements with a contract manufacturer <unk>.
Spect ICT C O internal facility to meet most of the commercial demand and we are intending to use contract manufacturing capacity to better manage demand and to provide additional flexibility.
The utilization that's the purpose of of sending that agreement for commercial manufacturing of the CMO.
Great. Thank you and then one fault if I can just as as you've done more work with the top 40 centers I have lunch do you have a better sense. If you expect about once a patient at lunch.
I see.
<unk>, yes, given the high unmet need and the lack of available treatments expecting a bit of up all this we haven't quantified that but to go semi commercialization standpoint is to make sure that we can support those patients.
Great. Thanks for taking our questions.
Thank you.
And our next question comes from the line of Mark breed Inbox with Oppenheimer.
Hey, guys. Thanks for taking the questions.
First of all is it stinks, you must be getting close to initiating the essentially confirmatory phase three study in frontline melanoma can you can you give us a little more information about the the trial protocol in terms of size and end points and maybe what time frame. The F. D. A would want you to complete passed by a court full approval.
And then the second question is just how soon we could see it'll be 3001 entered the clinic and and how would that most likely enter the clinic would it be kind of layered onto an existing trial like.
The basket study or whether it needed its own separate protocol. Thanks for taking the questions.
Yeah. Thanks, so when the phase three study will leave as we noted in our press release, we're still on track to begin that by the end of the year.
Haven't shared detailed study design, yet, but that's something that we hope to do in the near future.
And that will include endpoints and we'll details about how we.
That would be nice to be and it will be incorporating SDA feedback as well of course.
The confirmatory nature of the study will also be included so that discussion so stay tuned and we'll have some more time.
Timeframe to all I can say at this point is that we anticipate studying won't be well underway in time.
<unk> quickly accelerated BLA approval. So we think we're gonna be fine there.
For 3001, we haven't really talked a lot about that.
Yeah, probably.
Not necessarily assume it's going to be part of a basket study you might get it done study.
The idea of course is to swap out all does look at I look at 3001 actual.
Agent that can support until Griffin and expansion. So we're going to have the 2023, you should hear a lot more about 3001, because it will start to it.
Start to progress towards the clinic.
A piece of wood and you guys will I think will appreciate once we talk more about them.
Okay. Thanks, so much [laughter].
Thank you.
And our next question comes from the lineup Madhu Kumar with Goldman Sachs.
Good afternoon. This is amari <unk>. So we have two questions first.
What is the <unk> non small cell lung cancer population is you'll be considering for registrational population for like muscle and then second how should we think about P. D. One inactivated chills and melanoma and non small cell versus none none inactivate it feels.
So long it depends on.
Sorry did I.
Did you catch that I might've got cut off there.
Sorry can you guys can offer to can you hear me okay.
Yes, Sir I got I think I got cut off there. So I'll start over on Mars question list.
That's also one population you can looking at that can see the populations.
Corporate that way if you think about the posted you won't population you're talking many Mcdow agency here in the United States, we're feeling checkpoint tends to be accessible as until they're inaccurate target population for at least software studies and we're also working in the front line as well accommodations as us.
The P. One knockout products away you should think about that is.
Think about an internal knocked out of the P. One the gene PDC give me one that codes for P. One such a dead cell can't really be inhibited by <unk> Super size. So functions in many ways like having an antibody permanently attached to sell or embedded itself. We think it can actually be superior in terms of health penetrates the tumor and how it works.
We have some data it as you are this year, a few months ago, but acr's on our website and a poster the comparison he one knock out pills.
Two.
Non knocked out pills as well as to not among us until the combination with a few on anybody in a mouse model.
Alrighty that knocked out there as well.
Take a look at that and you'll see how we're thinking about it again, that's active in the clinic right now okay.
The holidays.
Alright, thank you.
Thank you.
And our next question comes from the line of <unk>.
Okay.
Hi, Good afternoon. This is <unk>. Thank you for taking our questions.
When did you show anyway.
C a D.
Highlighting the <unk> set up in relation to how long it's been seen salvation has finished in <unk>.
If I think of well there was an <unk> look better in patients who are basically came off <unk>.
Madonna you answer that one.
Yeah, absolutely. Thank you for the question. It's it's a very valid question. So the data is head is under embargo and I think what you may be also referring to is the differential effect of like lucid in patients who have primary refractory maybe has published the data and J C. O in may of two.
He won numerically the patients with primary refractory had a slightly higher or are compared to patients with acquired resistance that does not necessarily translate into a statistically superior outcome for these patients. So I think what you'd be able to see it said C. As as long as a patient is responding <unk> wanted to really benefit in in the.
<unk>, so <unk> onto the data edits under embargo at this time.
Okay understood. Thank you.
Thank you.
And our next question comes from the line of James Shane with Wells Fargo.
Yeah can you hear me.
Yes.
Fantastic.
<unk> <unk>.
Life's lucid belated completed well you issue a press release and then one for Igor.
For the 2000, plus patient capacity that's F. I T C. I T. T. C. Currently can you say how much of that is fully automated and free of human interaction.
Is this continuous at this point.
Yeah. So I'll take the first one is already in the second one yes, I think we will Luckily issue a press release very local issue a press release.
<unk> is complete it.
Sure.
James Thanks for the question so.
<unk> 20th two day journey to manufacturing process is still largely manual and automation and closing the process is something that we're working on to get to the next level of capacity, we expect that in order to reach 5000 patients per year, we can build out the existing shell. It is C. D C M.
To get to 10000 patients per year, we're looking at new facilities potentially end automating and and further streamlining the process that will be part of that effort.
I appreciate the caller thanks guys.
Thank you.
And our next question comes from the line of Eula live shapes with charges.
Hi, This is <unk> thanks for taking the question.
So.
Update some cheetah.
But one cancer.
Magenta for Grandma, you activated light.
Wondering if you could provide some color or national progress.
Indicated.
Data.
Over the next few months Uhm.
And a short to follow up on B E T T y and activated.
So.
The previous makes showing me.
Knock out efficiency of about 60 per cent.
<unk> do you think that.
And.
Alright.
Yeah, Let me let me see if I can understand the first question you were asking about updates to the head and neck trials on.
<unk> Dot Gov.
It was pretty hard to hear you there.
Oh, I'm, sorry, yeah, it does a lung cancer and the headache.
He would speak to my additional progress Darren Caden seven wall. My name you split it up you can expect.
I think I met.
Frederick you might have to help me out here, but I think you may be referring to changes in the contours, who study maybe for total enrollment.
<unk> can you answer that question and help with that.
[noise], yes, I I I I also have problems acoustically hearing the question, but it's so we we we do have this is a question about the head and neck cancer trials C 145 <unk>.
C T Dot golf currently for that trial, so that that child is completed.
And we are currently in the process of summarizing the data.
In the come to trial, we have recently made updates to the cohort sizes.
But but we haven't shared any any additional details around kind of like D C progress in enrollment or or or speed of enrollment on any of those specific cohort.
Does that answer your question.
Yes, It does and then I had a small it quick follow up to the people wanting activated cause I heard the question I heard that you asked whether 50 per cent adequate we report values in that range, we could do a little bit better than that sometimes but we think that's adequate to treat patients remember, we're giving patients.
Many billions of cells, a 50% that is still quite a large number you'd like the billions.
So, we're giving <unk> knockout cells and selzer are still have attacks D. C. One gene. So that's basically where the technology is these days for knock out if you look in the literature at some of the only work that was done to knock out percentages. For example, some of the early payment knockout studies like coming out of University.
Pennsylvania Roy 20%.
So we're comfortable with that amount, we think that's going to be useful.
Okay. Thank you [laughter].
Thank you.
And our next question comes from the lineup Kelsey Goodwin with Guggenheim.
Hey, Thank you so much for taking my question Uhm I just have two quick ones I think first now that's BLA submission is nearing completion I guess can you provide any additional color on X U S.
I think you've said that that that because of your facilities on the east coast of the U S. A could possibly produce some products are for any lunch, but maybe just a little more color and then secondly bigger picture question I guess, what steps can be taken to increase the referral rate is community physicians to the academic centers. Thanks, so much.
Well I'll take the first one and maybe Jim can talk about community referral so yesterday.
Country facility is located in a in a place actually both of US in the manufacturing facility, we own as well as our CMO partner located on the east coast to reach all the way into eastern Europe as well as.
That's the United States and beyond.
We do have an X U S strategy, we haven't talked about that much probably because it can focus on the U S. MBA, but we have Ah ongoing collaborations raccoon places ranging from all over Europe to Canada to Australia and beyond and those are all countries.
In the future for melanoma launches in particular for I was also on the other indications for looking Toby dot as well.
Talk with the community referral.
Thanks for adding Kalsi. Thanks for the question Yasushi know about 60% of our patients are dispersed into community.
And currently the referral patterns are not as strong as we would line. So we aren't using data driven approaches do identify the patients in the community to practices, what we'll have our sales team working with the top commute.
Community practices go into your education and outreach initiatives and then we'll also augment all of our efforts with non personal promotions to expand our reach and frequency.
Okay, great. Thank you so much.
Thanks.
Thank you.
Our next question comes from the line of S. T. The <unk> award and withdrew his.
[noise] Hello. This is an entrepreneur on for <unk>. A few questions. Here you guys said that you might be able to who knows about 2000 patients at large just wondering where you would be getting a new contract.
Contract manufacturers and also potentially.
Where are those centers administering hydrotaxis too would be if you've got more of them online.
And then secondly in terms of.
B 4001.
You mentioned that you patient goes to already and we're just wondering how enrollment was progressing in that trial.
Back the initial look at the data.
Eagle or would you like to take the first part of the question, maybe Jim couldn't talk about how docile too in Fredericton cover the.
Enrollment for 4001.
Yes.
He is happy to thank you for the questions. So as I mentioned earlier on the Cold V. I C. T C capacity of our internal facility is built is to supply more than 2000 patients annually.
We're not commenting exactly about the demand we expect in the year, one but does ticket posted it would have been the currently constructed facility.
The plan is to meet most of the commercial demand out of place CTC and then the role of the contract manufacture of manufacturing partner is to provide additional flexibility to optimally manage capacity and ensure that we're fully mutation demand. This lunch.
<unk> and I hope to raise you know hydrocele to use has decreased significantly over the years in fact.
We we have dated you identify each of the sites, where they're currently using I all too and we know most of our target sites. While they have experienced the uses Wayne rather significantly we have a very efficient training program to make sure that sites are trained on appropriate use for I O two.
And side effects management, so I don't expect it to be a barrier for lunch.
Mmm.
[noise] regarding Rick.
Regarding the I O V 4000, <unk>, what's the question around how this study is progressing that is working working very nicely.
<unk>, we had previously.
Previously shared the design of the study. This study does include the safety <unk> with a sequential dosing of patients since we are able to optimize.
Dot.
Avoiding any sort of delays between the patients so that's going really nicely.
A lot of interest in this study thanks for the question.
Thank you and our next month.
Calm when was it.
Hi, This is Jerry gone gone from Air Goldstein, Thanks for taking our questions I did lose connection for a short portion. So I apologize if any of my questions already asked.
So for a core to the circle cancer trial can you share of if you have settled on a target robot number and on cash burn what is your current thinking on Alan may It looked like a suite of regulatory approval process and then through launch and lastly on pricing is it fair to think about perhaps pricing in line with current a R. T products. Thank you.
Sure we haven't we haven't disclosed the details of the circle maximum enrollment just yet, but we'll we'll have some more details on that hopefully skin John Mark can you talk about the cash and maybe Jim can comment on pricing.
Sure sorry Krishna.
Yeah, so about the cash or trade or $256 million at the end of this call through I mean, we're we're confirming that.
We are being up front already into Princess once before so definitely a strong position as well as a jerk.
Your company reserved the risk of the lead programs and also you know until no manufacturing now are up and running and ready to to supply the demand from the commercialization. So we're not giving any specific guidance around 2024, you know cows room, but the game, we do have enough cash in through 2000 2004.
The stage.
[noise] Hi, this is Jim on pricing, we haven't disclosed pricing, but I think it is fair to think about the car T pricing is good analog and good range.
Gotcha, Thanks like color.
Thank you.
Comes from the line it was Alex <unk> with Barclays.
Hey, good afternoon. Thanks for taking my question. This is Alex on for Peter Los Angeles, I, just had a quick one on the on the lung cancer study and I was.
Wondering if you could comment a little bit on how enrollment has been going after you've made a few protocol amendments a couple of months ago any color around that could be helpful. Thank you.
Yeah, Frederick because you're talking about the only one to have to study could you comment on that.
Yeah sure happy to and Thanks. Other question, yes, so you rightly refer to some of the.
Adjustments that we've made lately, we actually really happy about.
We're able to activate the sites and how these sites are enrolling for the trial, we haven't shared any act and create numbers. We are really pretty pleased with the progress and that's about it.
But we will take you can share that we have more more than 40 active sites at this point, what you said.
Really healthy number or.
Like the.
Thank you.
Now I'll turn the call back over to interim President and C. E O frayed vote for any closing remarks.
Thank you again for joining the islands Biotherapeutics third quarter year to date of 2022 financial results Conference call.
Heading into an exciting and to be your high advanced included <unk> annual meeting next week as well as our upcoming expect to complete it.
<unk>.
As a preview we expect it on November 7th Subcontract for oral presentation, when we released.
Detailed look at the full data from codes too and for a R. C. A 144 O. One trial on November 8th there'll be a press program for members of the media covering the data in the abstract.
Finally on November 10th are all presentation will be presented with an update include additional follow up with a quote individual codes.
I'm grateful for the patients physicians and regulators as well as our employees and cross functional teams or worked in close collaboration to advance our mission.
Global leader until therapy.
I would also like to thank our shareholders covering analyst for their support.
Please feel free to reach out to our Investor relations team for any follow up thank you.
Ladies and gentlemen, this concludes today's conference call.
Mmm and you may now disconnect.
The conference will begin shortly to raise your hand, you and <unk> you can dial star one one.
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