Iovance Biotherapeutics Inc. Q1 2023 Earnings Call
Okay.
Hello, and thank you for standing by my name is Andrew and I'll be your conference operator today at this time I would like to welcome everyone to the aisles and bio Therapeutics first quarter 2023 financial results Conference call.
All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. If you'd like to ask a question. During this time simply press Star then one on your telephone keypad.
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It is now my pleasure to introduce senior Vice President Investor Relations and corporate Communications Sara Pellegrino.
Thank you operator, good afternoon, and thank you for joining us.
See you on today's call, we have doctor Fred vote, our interim President and Chief Executive Officer, Dr. Igor Balinsky, our Chief operating officer.
Jim Ziegler, our executive Vice President commercial Doctor Frederick Lincoln Stein, Our Chief Medical Officer, and John Martin <unk>, Our Chief Financial Officer Doctor Raj Peery, Our executive Vice President regulatory strategy and translational medicine is 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 months ended on March 31st 2023, as well as recent corporate update.
Before we start I would like to remind everyone that statements made during this conference call will include forward looking statements regarding <unk> goals business focus business plans and transaction pre commercial activities clinical trials and results regulatory interaction plans and strategies research employee.
Preclinical activities.
Potential future applications of our technologies manufacturing capabilities regulatory feedback and guidance payer interaction licenses in collaboration cash position and expense guidance and future update.
Well, we're 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.
We undertake no obligation to publicly update any forward looking statements.
With that introduction I will turn the call over to Fred.
Thank you Sarah and good afternoon, everyone.
I'm pleased to update you on a productive start to the year at I events in 2023.
We successfully completed our biologics license application or BLA for our lead til therapy like <unk> Lusso in advanced melanoma at the end of the first quarter. This represents a critical step forward in our journey to deliver the first individualized onetime T cell therapy for solid tumor.
I would like to acknowledge the patients and physicians who participated in the C. One for 401 clinical trial.
And the FDA review team for their commitment and support as well as our internal team for their tremendous effort and completing the first BLA submission for <unk>.
We look forward to continued collaboration with the FDA as they review this new class of treatment for advanced melanoma patients with limited options.
Terms of next steps.
The FDA has 60 days from when we completed the submission to determine the acceptability of the BLA for review, which is approximately may 26, we will provide.
An update as soon as we can.
Accepted for a six month priority review that would result in a decision on approval by late November we feel confident going into the BLA review process, given the unmet medical need and strength of our clinical data as well as several positive interactions with and feedback from the FDA.
As we prepare for potential commercialization. We are also developing a robust immuno oncology pipeline.
And plan to execute integration plan for Proleukin.
Earliest earlier this year, we entered into a strategic transaction with <unk> to acquire the worldwide rights to Proleukin.
Two product with currently approved indications such as importantly, also used to promote T cell activity following til infusion.
We expect per Lucan to provide revenue in full control of the IL two supply chain and logistics surrounding til therapy as well as the reduction in both clinical trial expenses and future cost of goods for life a looser.
We expect to close this transaction imminently and we will file our Form 10-Q tomorrow afternoon with more information.
In addition, our robust til therapy pipeline includes seven active clinical trials in multiple solid tumor types with the potential to create significant value for cancer patients and shareholders.
As we grow our organization that transition to a commercial company. We currently have more than 500 I've asked employees.
<unk> in developing and commercializing oncology and cell and gene therapy products.
I look forward to addressing your questions later during this call and we'll now ask you go to present, our manufacturing updates.
Thank you Fred.
Factoring is essential for us to successfully launch and deliver life of listen to patients.
Committed to operational excellence and have provided til therapy to more than 600 patients to date with a consistent manufacturing success rate of more than 90%.
Right now our top priority is to support the FDA BLA review process to prepare for the pre approval inspections and scale up our internal capabilities and staffing to meet patient needs for commercial supply at launch.
We have done significant work to thoroughly prepare the ICD.
And our contract manufacturers facility for commercial launch as well as for ongoing clinical supply of trials.
The ICT seat, which is expected to supply most of the commercial til therapies. Upon approval has been supplying clinical studies since the third quarter of 2021, while supporting expanded access and preparing for commercial readiness.
In addition, our contract manufacturers.
Further flexibility to optimally balance capacity and patient demand.
We are also planning for future commercial and clinical capacity needs as we look to establish <unk> as the next paradigm shifting plus of cancer therapy. The ICC is built to supply two products for more than 2000 patients annually. We are on track with our hiring plan to support our forecasts.
The demand Thats launch ultimately by building out the additional existing shelf space. The ICC is designed to supply til products for more than 5000 patients annually.
Longer term our vision is to build capacity for more than 10000 patients annually through the addition of new facilities as well as streamlining and automating manufacturing processes.
Turning to our intellectual property or IP. We're currently owned at least 60 granted or allowed the U S and international patents, including Gen. Two patent rights that we expect to provide exclusivity into 2038.
Extensive detail on our events owned IP, which is a critical component to support and protect our proprietary manufacturing processes and Knowhow is available on our corporate web site and was in our annual report on Form 10-K.
Now I'd like to hand, the call over to Jim Ziegler to highlight our commercial launch preparations Jim.
Thank you Igor our commercial launch readiness activities with authorized treatment centers or ATC and payers are on track and aligned with our regulatory milestones.
Our cross functional teams are making steady progress towards onboarding in developing til cell therapy service lines at our ATC.
Our leadership team has also been visiting several ATC as part of the Onboarding process and we are hearing strong enthusiasm to opera <unk> cell therapy, as a new treatment option upon approval.
In conjunction with our capacity planning for light Blue. So our Onboarding process also includes market research and assessment of bed capacity at each hospital.
Our targeted atc's have given consistent feedback that they have inpatient hospital beds to support cell therapies, including LIFO Leucyl and we believe our atc's can accommodate our expected demand for LIFO lusso at launch.
Our payer engagement also remains strong following our completed BLA submission.
Reimbursement and access expectations for life, a looser are consistent with other car T cell therapies, which often include prior authorizations and single case agreements between hospitals and payers.
Our goal is to ensure patients have timely access to <unk> and our <unk> reimbursement and patient support programs will offer support for <unk> in patients.
In closing we remain on track for commercial launch. Thank you bye bye.
Including.
Operational readiness for Proleukin I want to thank our dedicated cross functional teams, who are working tirelessly because patients are counting on us.
I will now pass the call Dr. Friedrich Finkelstein, our Chief Medical officer to highlight our clinical progress.
Thank you Jim.
I would like to summarize recent updates with our til therapy pipeline of next generation technologies.
Craig mentioned, we completed our BLA submission for life, a looser and post anti PD one advanced melanoma in late March we are confident in the potential for FDA accelerated approval, we have Amit designation positive results from our <unk>, one for Florida Zero, one trial, which is the largest single clinical study ever conducted for cell therapy and <unk>.
Both ICI melanoma and FDA agreement for the Phase III till then 301 trial.
<unk> 301, which we expect to be well underway at the time of potential approval is designed to serve as our registrational trials for accelerated and full approval supply solution in combination with embolism up in frontline advanced melanoma as well as a confirmatory trial to support full approval of life elusive and post anti <unk>.
PD one advanced melanoma.
We recently activated <unk>.
The trial is now actively enrolling patients randomized the first patient soon.
As a reminder, we plan to randomize 670 patients who are naive to therapy in the advanced setting to either like the Lutheran combination with timber lithium up in the experimental arm, while <unk> as a monotherapy in the control arm.
While as expected to include an appropriate number of global sites in key geographies with a large presence of melanoma patients and the potential for strong enrollment, including the U S, Australia, Canada and Europe .
Additional information on participating sites trial design outcome measures and the eligibility criteria are available on clinical trials Dot Gov.
We also continue to execute on our non small cell lung cancer or in SCLC pipeline at <unk> with.
Six cohorts across three <unk> studies to investigate multiple treatment regimens in various populations in various stages of disease.
In the first quarter, we shared positive initial data for our til therapy 11, 145 in combination with timber listen up from cohort three eight of the IOP come to two trial in patients with advanced and our CLC.
Ive to ICI treatment base.
Based on these positive results, particularly within the treatment naive and post chemotherapy subsets of patients we plan to meet with FDA in 2023 to discuss data and a potential registration path for life, a looser in frontline advanced in the CLC patients.
Enrolment to cord AA is ongoing and we plan to present detailed and updated results at a medical meeting in the second half of this year.
Ah patients with non small cell lung cancer, who are more advanced in their disease.
<unk> <unk> 202 trial is investigating at any one five monotherapy after a prior anti PD one in chemotherapy.
Trial, which includes an option for a pre progression tumor harvest as well as til product manufactured from starting core biopsy tumor material is expected to continue enrollment throughout this year.
Moving to cervical cancer are expanded cohort two in the ongoing <unk> one for a flight or for trial is investigating life Duluth following progression on or after chemotherapy and anti PD one therapy.
Based on our dialogue and feedback from FDA cohort two is intended to be pivotal to support regulatory submissions and we look forward to continuing enrollment this year.
We are also excited about our next generation til therapies, particularly ILB thwart one and other genetically modified til therapies that utilize the gene editing talent technology licensed from selective to optimize til therapy by Inactivating immune checkpoint proteins that inhibits <unk>.
Anti tumor response.
We are investigating <unk> for one that PD, one inactivated til therapy candidate and our first in human <unk> GM, one 201 trial in patients with previously treated advanced melanoma or CLC.
Additional programs using the talent technology are expected to enter clinical development in 2024, including genetically modified til therapy with multiple inactivated immune checkpoint targets.
Our research and preclinical studies also include IMD, enabling studies for our novel Interleukin two analog <unk> three one and approaches to increase till potency, including the selection of CD 39, 69 double negative pills and enhancements such as cytokine.
I am available for questions. During the question and answer session for now I will hand, the call over to Mark to discuss our first quarter of 2023 financial results.
Thank you Farooq.
My comments will summarize the planned acquisition of Proleukin as well as the high level financial results for first quarter ended on March 31st 2023.
More details can be found in this afternoon's press release as well as in our SEC filings.
At the end of January we announced that we have.
<unk> entered into an agreement to acquire Proleukin.
John .
In terms of the agreement to include an upfront payment of 167 7 million British pounds.
$41 7 million British pounds milestone payment upon first approval of LIFO Lusso, Netherlands melanoma.
Double digit Proleukin global sales royalties.
Once completed yet.
The transaction will be financed with existing cash and is expected to close imminently.
As Fred mentioned, we expect Proleukin provides broken you're in full control of the IL two supply chain and logistics surrounding til therapy.
We anticipate significant revenue for poor looking to begin after the launch of <unk>.
We continue to invest in launch preparations.
Manufacturing and pipeline activities.
As of March 31, 2023.
632, $7 million in cash cash equivalents investments and restricted cash compared to $478 3 million as of December 31 2022.
Our current cash position includes approximately 260 million.
Net proceeds.
Is it true that the market or ATM financing facility during the first quarter of 2020.
This cash position is expected to found our operating plan into the second half of 2024, including the <unk> acquisition manufacturing activities launch readiness and execution ongoing and planned clinical trials and pipeline advancement.
Transitioning to the financial results for the first quarter ended on March 31st 2020.
Our net loss was $107 4 million.
All 50 per shares.
Compared to a net loss of $91 6 million or <unk> 58 per share for the first quarter of 2022.
Research and development expenses were $82 7 million.
For the first quarter of 2003.
And an increase of $14 4 million.
Compared to $68 3 million for the first quarter of 2022.
This year over year increase in research and development expenses was primarily attributable to growth of total research and development team as well as clinical trial costs cost to support commercial manufacturing readiness and facility related costs, which were partially offset by lower stock based compensation.
Expense.
General and administrative expenses were up $28 1 million.
For the first quarter of 2023 and.
An increase of $4 7 million compared to $23 4 million for the first quarter of 2022.
The increase in general and administrative expenses in the first quarter of 2020.
Compared to the prior year period was primarily attributable to growth of internal general and administrative and commercial teams in preparation for launch.
Pleased to support the <unk> acquisition as well as cost associated with pre commercial activities activities, which were partially offset by lower stock based compensation and marketing expenses.
As of March 31st 2023.
There were approximately $224 4 million <unk> common share outstanding.
I will now hand, the call back to the operator to kick off the Q&A session.
Thank you.
As a reminder to ask a question you will need to press star one on your telephone. If your question has been answered or you wish to remove yourself from the queue Press star one again.
Once again to ask a question press star one.
And our first question comes from the line of Michael Yee with Jefferies.
Hey, guys. Thanks for the questions and congrats on the progress.
The two areas of questions. One was as you go about the regulatory process can you just shed some light on your.
Expectations for an AD com and what discussions you may have had about that as well as your expectations for an FDA inspection for the factory and how that process would go about during the regulatory timelines that you laid out and the second question is about preparation for launch can you just remind me.
How many ATC centers you expect at the start.
And whether you feel comfortable about reimbursement I know you've mentioned you have J codes and all of their sort of before and if you go back to car T that was a real gating factor for the launch. So could you just talk about whether you expect that to be an issue or not and you would expect it to be a.
Pretty.
Straightforward.
The coach Thank you.
Yes, Mike.
Regarding an AD com right now as we've said before we don't expect an AD comm, we think FCA has seen enough T cell therapies at this point. However, if we get one will get word of that fairly soon and we would.
Could talk more about that at that time typically that comes after acceptance of the BLA.
Regarding inspection and timing for inspections, what we call a pre licensing inspections. Those are things that occur typically towards the end of the review cycle. They will core occur around late third quarter or something like that this year.
Potentially we don't know if the it might tell us give us more detail and give us more insight and that at some point, but we are preparing today heavily at all of our sites, including our manufacturing related ICT and swells at Wuxi in.
Everywhere else in our organization for the <unk> as well as for what's called the <unk> by our research monitoring DCP audit. So we intend to be in very good shape when that happens.
And for the ATC that start.
We've said as we've said publicly we're aiming for 40 Atc's start.
<unk>.
That's something we'll watch with either 40 at the time of launch or shortly thereafter.
You mentioned J codes that Jacobs on applying our space, we're more interested in what's called MST RJ for Medicare as well as.
Getting ourselves in line with single case agreements with the.
With the private payers before they issue their coverage policies all of that is going very well, maybe Jim if you want it because you want to add anything to that.
I think you covered most of it just a reminder, our goal is to launch with top 40 Atc's within the first 90 days of approval and on the reimbursement front over.
Over the past couple of years, we've had a team out there engaging payers, we engage payers responsible for 90% of covered lives for our commercial and Medicare patients and.
We are confident in our approach and that payers understand the unmet need and the clinical data that we've shared thus far.
Right.
Okay.
Okay.
Thank you.
And our next question comes from the line of Peter Lawson with Barclays.
Great. Thanks, so much to advance 301 trial, just kind of how we should be thinking about that.
The balance of U S versus ex U S sites.
Yes, we're going to be international fully there Peter maybe I.
Can say a few words in refrigerant can add but we are intending to have European sites were intending to have Australian sites and beyond so some stuff. We talked about you can see this in the script and elsewhere.
Today's call, but we are intending it to be a very international trial.
We're well underway in those in those respects project you want to add anything.
Yes, I totally agree we have interactions with sites and investigators across across all the regions that we that we were commenting on there.
Our presentation. So we are not intending to intentionally.
Go for one region over another one we are working with with with all of these spaces and the same in the same way and the activities are ongoing in all of them.
Got you and then on the loan just the data that you will be sharing this year, how much data should we expect for cohort three.
I think Peter you will see something similar.
A little bit incremental to what we've put out previously because.
Because we've had some more time, but it's not going to be a huge increase in what we put out in January but it should be significant data obviously since that data.
It was of course very important.
I think when you see the additional data you're and why we're so excited about it.
Is there anything else, we should be thinking about with regards to the BLA acceptance is that kind of it.
End of May kind of event or.
Anything else, we should be contemplating.
As it is in end of May kind of event no I think we're we're in May right now we've got a BLA acceptance that we just we just mentioned around May 26, that's kind of the big amount for May.
We put out some of the information about what we'll be doing it ask us. So you can see that in the press release today, but relief or three AAM for some other data releases youre looking at the second half of this year.
Okay perfect. Thanks, so much.
Yes.
Thank you and our next question comes from the line of choline <unk> with Baird.
Good afternoon, thanks for taking our questions. So further confirmed confirmatory study told answered the FCC.
Adjusted to you that a certain proportion of the study should be enrolled before they would grant accelerated approval and if there hasn't been any communication do you have an internal goal for enrollment at the time of approval.
No they've never said anything about percentage of enrollment they use the term well underway with us in a in fact, they told US they were pretty happy when we presented the trial to them about our timing last year.
I have not given us anything like that.
We do have internal targets for enrollment of course.
They are quite aggressive, but we cant at this point, we're not going to be disclosing those right now.
Understood. Thank you and.
I guess another question on enrollment just this one on the cervical cancer study any update on how that enrollment is going and how quickly you could expect to file using that data.
Okay.
Right now the study is enrolling quite well maybe fredrik you can take a little bit of this after after I finish here, but it's enrolling well, where we don't have really an update for you just yet we just restarted the trial not too long ago.
We are.
Bullish about this we're very focused obviously on the melanoma BLA first though so I think after we've ethanol BLA youll hear more from us about cervical.
Fred do you want to give any.
You are calling an idea of how the investigators feel about cervical right now and how it's gone.
Yes, maybe just as a additional color I mean, given that we had to that we had to restart this cohort.
Because we had initially communicated.
We were holding enrollment and then we restarted as I've shared before.
Im actually pretty pleased with where we are with the level of engagement by sites and investigators ethane enrollment at this time.
It's going well.
Great. Thanks for taking my questions.
Thank you and our next question comes from the line of Reni Benjamin with JMP Securities.
Hey, good afternoon, guys. Thanks for taking the questions and congratulations.
On the filing and all the progress.
Fred can you talk a little bit any and all the interactions that might be occurring between the regulatory agency.
Between now and the acceptance of reviewed is.
Do you get a sense as to maybe how things are going or is there any back and forth that takes place.
Before they kind of.
The comes up that it's ready for review.
Yes, there has been there's been an FDA then there they seem to be very very interested and BLA theres been a lot of good engagement.
It's really it doesn't enter the review process until after acceptance, but at this stage I can say what I can tell you that at least for the caller level is there.
They're engaged they're interested they're asking about things that we think are important.
They seem to be very interested in the clinical data and those are all things that we take as good signs.
Okay and then.
Maybe it's a little bit too early to talk about it but as we think about.
Potential acceptance than theirs.
The manufacturing site visits and things like that I'd love to get some sort of commentary on what you think would be the most ideal label for you guys to negotiating versus maybe what might be a base case and a label that youre thinking about.
Alright, Braden Bach with Oppenheimer.
Hey, good afternoon, thanks for taking our questions.
Couple of quick ones for me on that the pending Proleukin acquisition can you can you remind us if if that deal comes with any sales personnel, specifically with experience and and promoting proleukin and and maybe it would be helpful. If you if you're kind of.
I'll spell out for us how the upfront payment to <unk> will be recognized on your piano as well as the.
The potential milestone that would come with.
<unk> approval or there's going to be kind of like lump sum payments or they can be spread out of it thanks for taking our questions.
Alright, I'll take the first one that job Mark can talk to you about the piano Ah. Yes, we we are getting pillows for Luke and people punishing people as part of the deal.
And we've also gone out with hired some people that have experience in this area as well. So we think we're going to have a fully staffed team and commercial medical affairs and beyond proposal concluding on the manufacturing side, we intend to have the expertise to keep the product.
Rolling and also support the expansion of the product is like a looser watches the U S.
John Mark you might talk a little bit about P&L and how we're gonna recognize.
Expenses.
Yeah. So thank you for a Christian also under the term of the agreement we'd have to thinks that we will consider but this will be her tush related activities mean, we'll have an upfront payment of.
Roughly we talk about 200 million dollar, it's exactly 167, <unk> seven you're gonna British pounds.
Will be you know routine right away or cash at the time of the could you clues and then we will have a milestone that will be paid which will be roughly 50 million dollar 41.7 million British pounds at the time of the first approval of <unk>, but those two events off to be considered.
Cash flow related activities <unk> I come to England.
Got it okay. Thanks for taking the questions.
Thank you and our next question comes from the line of Mara go skiing with Missoula, though.
Great. Thanks, so much for taking my question with.
With respect to the.
Mm K E. T. C is when you and your commercial plan.
Quickly or what is like the time or the lag for a T. C to begin to treat patients once product is approved.
They can lose that commercial Sam look like.
Yeah. So it's a very very rapid Mar it's something that they can do very quickly we have the ATC stood up.
In fact, I visited one last week and saw how ready they work for this.
We have a great team.
Jim's team as well as your medical affairs team in our ATC operations team are out there, making sure that the sites are ready.
To go as soon as the products approved so it's something that the.
The the structure will be in place the financial side will be in place the operational side will be in place everything will be ready for the for the launch as if it was a traditional like lots of the car keys.
Okay, and if I could just ask another question given there are trials running you know also in melanoma, although obviously different I mean are you in the a T six competing philosopher clinical child patience.
No we don't really see that as a major limitation right now for us.
Okay, that's really nice.
Thank you I appreciate it.
Thank you and our next question comes from the line of S. T <unk> truest.
Hi, This is karina for us to come I had a question on the children's three one study.
Has the first first nations and those yet and how many sites device plans to activate.
Thank you.
Oh, well now it's when we randomize the first patient hasn't occurred yet, but it's it's hopefully quite eminent now and we'll talk about that as soon as we can.
We haven't disclosed the number of sites, yet, but it's going to be a large international trial. So you can assume it's going to be very significant numbers of sites.
Okay, and you said, it's gonna be outside of the U S, primarily or what's the percentage.
Are you looking at.
I will have a lot of U S centers, and we will have European centers, Australia and centers, we intend to go elsewhere beyond that it's going to be a true international Intercontinental study.
I don't know the percentages yet that's something that will establish as we go through the course of starting up a large international trolley. This.
Okay. Thank you.
Thank you and our next question comes from the line of Michael Schmidt with Google Guggenheim [noise].
Yeah.
Hi, This is E D M for Michael Thanks for taking our questions quick one from us for second and third line non small cell lung cancer can you talk about your current thinking on the bar in the <unk> given that multiple upcoming face can be read out of a b c's and <unk>. Thank.
Thank you.
Yeah, Frederick do you Wanna talk about that.
Yeah. So I think four bars in this space I think you would you would have to look at the available at approved approved therapy at this point things to look at the <unk>.
R R docetaxel mono therapy or dose of tactical Muhs, that's running a fair amount that's that's.
Usually it and accepted benchmark for for setting up this year.
This evolve we're going to have to look carefully note that F. D. A as they are looking at a particularly single arm data.
Those looking at the available available therapy at the time you bring this forward, but right now.
Tactful dose of <unk> or is the most appropriate benchmark to to look at.
Thank you.
And as a reminder to ask a question. Please press star one on your telephone.
Again to ask a question please press star one.
And our next question comes from the lineup Madhu Kumar with Goldman Sachs.
Yeah. Thanks for taking our questions. So I just kind of can we expect any more updates from cohort for from the ongoing car to court trials in terms of things like overall survival and kind of longer term follow up on therapy from that study.
At some point, we might Madhu, but we put out overall survival data since last year and it was pretty mature.
So I would like it we can send you a link to that but.
Not a whole lot of reason for us to go back into that again, you can see the hotel when those curves has been kind of read from the capital Myers.
And there's okay well that.
That came with that we didn't remember we did a companion publication last year, Tennessee could check them both of them.
Yeah, absolutely so that'd be kinda following up on the bed capacity commentary there isn't really about eight cases, what do you think I launch is going to be kind of the effective number of beds there'll be available and what are you using the steady state while I'm thinking about the city of and last year, where they talk back and I really.
Beds on average per site per megawatt do you think that's a reasonable number how are you thinking about kind of where the study's here. It's gonna lie in terms of kind of available hospital use capacity.
No I think you're going to see much much higher capacities I visited the site last week, where they they show me capacities it far far far exceed that in their B M. P. L O till cartoons units.
So I I do I do think maybe that's something that people should understand better about the sites that they really are they're building for cell therapies. This is an economic opportunity for hospitals too and they are expanding expanding and trying to get ahead of this and this.
Sites that we're working with don't seem to have that limitation is a gerbil matter.
Yes, it came up associate with a comment made at city, but it's not something we've seen very often.
Oh by the way men do I got I pulled the slight curve from since he goes after 60 months.
Pretty good.
Mhm.
Okay, and then one last one on that point, though.
With the launch of little looser and posted one melanoma, where do you think the bottleneck potentially would be would it be on kind of.
Factor would it be on bed capacity like what do you think you're gonna be so when you look at kind of a test case ride from D. C. M. A R. T drugs, there's a bottleneck on manufacturing like where do you think the kind of right. Let me step will effectively be.
Well they had manufacturing is there a limit or were trying to make sure that doesn't happen by building big there we've talked about that.
That we just discussed I don't think that's going to be over a limiter I don't know exactly where it will occur at this point, we're gonna have to test it and see at this point, but we're building big and we're preparing for a very large successful launch. So hopefully whatever happens will not will not appear to be a drag from one of those things and we'll be able to achieve numbers that are appropriate for the patient demand it's out there.
Okay, great. Thank you very much everybody.
Thank you and I'm showing no further questions at this time, so with that I'll have to call back over to interim C. E O Fred vote for closing remarks.
Thank you again for joining the I advanced Biotherapeutics first quarter of 2023 financial results in corporate update conference call.
An exciting start to 2023 upon completing the BLA entering the Proleukin agreement in delivering on our key regulatory commercial manufacturing and pipeline activities.
I'm grateful for the patients physicians regulators as well as our employees and cross functional teams have collaborated on our beliefs submission, while advancing our mission to be the global leader until therapy.
I would also like to thank our shareholders covering analysts for their support.
Please feel free to reach out to our Investor relations team for follow up thank you.
Ladies and gentlemen, this concludes today's conference call.
[music].