Q2 2023 Iovance Biotherapeutics Inc Earnings Call
Okay.
Welcome to dial Vance Biotherapeutics second quarter 2023 financial results and corporate update conference call. My name is Shannon 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 answer session.
Please note that this conference is being recorded I will now.
Turn the call over to Sara Pellegrino Senior Vice President Investor Relations Corporate Communications and I'll dance, Sir you may begin.
Yeah.
Thank you operator, good afternoon, and thank you for joining US speaking on today's call, we have doctor Fred though our interim President and Chief Executive Officer, Dr. Igor Balinsky, our Chief operating Officer, Jim Ziegler, Our executive Vice President commercial.
Doctor Friedrichs, Lincoln Stein, our Chief Medical Officer, and John Marc Baumann, Our Chief Financial Officer.
Dr. Brian Gassmann 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 six months ended June 30th 2023, 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 Io that the coal business focus business plans and transaction revenue pre commercial activities clinical trials and results.
Inventory interactions plans and strategies research and preclinical activities potential future applications of our technologies manufacturing capabilities regulatory feedback and guidance per interaction licenses done collaboration cash position, an 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.
We undertake no obligation to publicly update any forward looking statements with that I will turn the call over to Fred.
Thank you Sarah and good afternoon, everyone I.
I am pleased to highlight several important milestones drive answering the second quarter of 2023 and more recently.
Our biologics license application or BLA for our lead til therapy like Leucyl in advanced melanoma was accepted by the U S food and drug administration or FDA for six month priority review and granted a <unk> date of November 25 2023.
And the acceptance letter the FDA also informed us that they do not intend to host an advisory Committee meeting and there are no major review issues were identified.
Life Leucyl, if approved will be the first cell therapy for treatment of melanoma. In addition to first individualized onetime T cell therapy for solid tumor cancer.
During the priority review process, we are continuing to collaborate with the FDA as they review this new class of treatment for advanced melanoma patients with limited options.
We remain confident in our prospects for approval given the unmet medical need our strong clinical data and a positive interactions with feedback from the FDA.
As we approach our Paducah date, we're building capacity and staffing arrive in cell therapy Center ICP C to supply our projected demand looser at launch.
Our field teams are proceeding as planned with Onboarding and site readiness activities for our authorized treatment centers or atc's.
To treat the first life Elisa patient as soon as possible upon approval.
I would also like to highlight that we are now a commercial stage company. After closing our transaction to acquire Proleukin IL two product used as part of the til therapy regimen.
Hey.
We are integrating <unk> into our organization as we prepare to launch life Leucyl. So that we can offer two important parts of the toll regimen.
As noted in today's press release, we recognized some revenue for the first time from Proleukin sales and expect to realize more significant revenue with the launch of <unk>.
<unk> also provides us with full control of the IL, two supply chain and logistics surrounding til therapy.
And we expect lower clinical trial expenses and future cost of goods for life of Luzon.
Beyond our regulatory and commercial readiness activities for life Leucyl, a robust til therapy pipeline includes seven active clinical trials with the potential to strengthen and broaden our mission to be the global leader in developing and delivering til therapies for people with cancer across multiple solid tumors.
Frontline melanoma, a confirmatory trial till the ancillary or one has begun randomized patients.
It remains poised to be well underway upon a potential approval life Leucyl later this year.
We have also made significant progress across our trials in non small cell lung cancer and our CLC, We recently announced positive clinical and regulatory updates related to the IV you want to add to our Registrational single arm phase II trial in post anti PD, one lung cancer.
At the upcoming World Congress on lung cancer, or WCS <unk>, Singapore, we look forward to presenting detailed data from cohort three a.
Of our IRB commentary two trial, an anti PD, one naive lung cancer. The <unk> data supports our strategy and upcoming trial in frontline lung cancer.
Trial in frontline lung cancer can also potentially serve as a confirmatory trial to support an accelerated approval based on the IV <unk> trial.
As we prepare to launch late for Leucyl.
<unk> now has almost 600 employees with experience in developing and commercializing oncology and cell and gene therapy products.
Look forward to addressing your questions later during this call and we'll now ask you to present, our manufacturing updates.
Thank you Brendan.
It has been a productive first half of the year at ITC.
We are preparing for the commercial launch of life of Luzon and building the manufacturing organization to supply.
The patients upon approval, while providing supply for our clinical trials.
<unk> extended axis.
We're committed to operational excellence and have provided til therapy for to for more than 600 patients to date with a consistent manufacturing success rate of more than 90%.
Our capacity of hiring plans remain on track to support our forecasted demand at lunch.
The ITC is expected to supply in most of the commercial til therapies upon approval with our contract manufacturers, providing further flexibility to optimally balance capacity and patient demand.
We will look to establish <unk> as the next paradigm shifting class of cancer therapy, and the ICC is currently built to supply two products from more than 2000 patients annually.
Additional existing shelf space by CDC can also been built out to ultimately supply food products for more than 5000 patients annually from this facility.
Longer term, our vision is to build capacity for more than 10000 patients annually.
Adding new facilities as well as streamlining and automating manufacturing processes.
Intellectual appropriate to your IP is also a critical component that <unk> that supports and predict our proprietary manufacturing processes and knowhow.
We're currently owned at least 60 granted or allowed U S and international patents, including Gen. Two patent rights that we expect to provide exclusivity into 2038.
Extensive detailed eventful night.
It is available on our corporate website and within our annual report on Form 10-K.
I would now like to hand, the call over to Jim Ziegler to highlight our commercial launch preparations Jim.
Thank you Igor and other events, we are pioneering til therapy with the potential to transform the practice of medicine in advanced melanoma in additional solid tumors are.
Our experienced commercial and cross functional teams with deep cell therapy experience are building the foundation for a strong Michael Rousseau launch, while integrating proleukin to offer as a supportive part of the <unk> regimen.
Commercial launch readiness is on track as we approach our 25 November Paducah date.
I will highlight onboarding for our authorized treatment centers or ATC, private and public payer engagement and commercial operational readiness activities.
First we are well positioned to achieve our goal to onboard 40 atc's within the first 90 days.
We are actively working with adcs to operationalize their til service line capabilities and to ensure multi disciplinary teams at each center are ready to administer <unk> treatment regimen upon FDA approval.
A significant number of Adcs are currently participating in the Onboarding process and we believe they are excited about offering til therapy.
This high level of enthusiasm.
As reflected by significant investments of time and resources to develop their tail service line and to prepare for anticipated demand and capacity needs among advanced melanoma patients.
Bed capacity for example is SaaS Darrin, our onboarding process, our targeted Atc's report sufficient inpatient hospital beds to accommodate and support LIFO lusso and other cell therapies.
We are also piloting our Io advanced cares enrollment scheduling and change of identity and chain of custody capabilities and training curriculum.
We are encouraged as atc's have provided positive feedback on our customer centric <unk> carriers design and bill.
Turning to market access or reimbursement strategies are on track to ensure timely and appropriate access for patients upon approval our market access team continues to engage the key national and regional payers, who are responsible for approximately 90% of covered lives.
Based on our payer interactions, we expect coverage consistent with label and similar to recent car Ts for Medicare patients hospitals already have reimbursement established under DRG 018, which provides more appropriate payment immediately upon launch.
As we prepare for launch I want to acknowledge our cross functional teams who are committed to ensure patients can be treated at ATC.
Access to reimbursement for LIFO looser upon approval.
I will now pass the call to Friedrich Finkelstein, our Chief Medical officer to highlight our clinical progress.
Thank you Tim.
Today, I would like to summarize recent updates with our til therapy pipeline and next generation technology.
I'll begin with <unk>, our registrational trial for accelerated and full approval.
Some combination with tempered as the map in frontline advanced.
In a normal.
Until then for you. One is also designed this confirmatory trial to support full approval of life of Northland pulsed anti PD one in melanoma.
The first patient was randomized and the second club until that 301 remains on track to be well underway at the time of potential approval of life of loan later. This year. We also continued to activate the global sites in key geographies with a large presence of melanoma patients and the potential for strong enrollment.
And non small cell lung cancer, we have six cohorts across three studies to investigate multiple treatment regimen in various populations and stages of disease.
This afternoon, I will highlight our Iot <unk> Registrational trial.
Post anti PD, one non small cell lung cancer patients as well as the anti PD, one naive non small cell lung cancer patient cohort three eight.
I'll come to a basket trial.
Last month, we reported regulatory and clinical update for our Registrational phase III <unk> trial, and potent anti PD, one non small cell lung cancer.
At a type b pre phase III meeting the FDA provided positive regulatory feedback on the design.
One of the single arm phase two <unk>.
202 trial may be acceptable for approval and then one for til therapy and post anti PD, one non small cell lung cancer.
Wanted to include our Registrational population of Egfr Roth.
Our alimentation negative patients who have progressed on or after chemotherapy and anti PD one therapy.
For patients with actionable genomic mutations other than Egfr Rafael will require at least one line of an FDA approved targeted therapies indicated.
Based on the regulatory discussions we completed a preliminary analysis of the Registrational cohort, one and two of the ILD and <unk> trial.
We are very pleased with the initial or our enduro ability from this analysis.
Confirmed or RFID resist personal one one was 26, 1% all six responses were ongoing at the time of the data analysis, including one complete response five partial responses.
Duration of response on <unk> was not reached and the ongoing responses ranged from one four to $9 seven plus months.
Looking ahead, we are amending the protocol to enroll a total of approximately 120 patients with in cohorts, one and two enrollment.
Enrolment is already underway at more than 40 active clinical sites in the U S, Canada, and Europe , and we expect to fully enroll our registrational cohorts in the second half of 2024.
Based on the FDA feedback we plan to pursue accelerated approval based on the <unk> two trial.
<unk> trial in frontline advanced non small cell lung cancer, which we will discuss with FDA. Later this year designed to serve as the confirmatory trial.
Our strategy in frontline advanced non small cell lung cancer proceeding in parallel we plan to report detailed data from cohort three eight of the Iot come to trial at the upcoming World Conference on lung cancer.
Good three eight is investigating til therapy, and then were <unk> 45 in combination with <unk> in patients with advanced multiple.
Most of the non cancer, who are not easy to ICI treatments.
We reported positive topline results from cohort three eight and a corporate update earlier this year and the press release confirmed or our buy versus 140.
47% eight responders out of 17 patients.
Moving to ongoing complete responses or Crs.
Responses were observed regardless of PD lone status and safety was consistent with other studies of Io that til therapy is in combination with Templeton.
We have been very pleased by the response rates and durability of that so far.
And the distinct clinical subset some cost me.
<unk> was 80% and five patients who were treatment naive and 43% and seven patients who had progressed after chemotherapy.
Or was 58, 7% when combining the 12 patients and the treatment naive post chemo Egfr wild type populations.
This results from the design and target population up our planned frontline phase III study.
In addition, we were encouraged to observe one complete response, among the five patients with Egfr mutation positive tumors and progression after prior treatment with Tpa, who typically do not respond.
Hello.
At W. CLC, we plan to report durability as additional cohort three data in approximately the same number of patients the.
The initial results will be published in abstract on August 16th.
And then an updated data analysis with additional duration of follow up will be included in the oral presentation of temporary labor.
We are also preparing to meet with FDA. This year to discuss the cohort three data and our proposed registration trial for nitroglycerine in frontline.
Cancer patients, which is designed to support full approval in frontline non small cell lung cancer.
This confirmatory trial supporting full approval and post anti PD, one non small cell lung cancer.
Our goal is to improve frontline non small cell lung cancer therapy by adding til therapy to standard of care <unk> maintenance therapy administered after completion of the initial chemo immunotherapy.
Our confidence in this approach.
But by the encouraging responses in operations with the tills Pampa different combination in cohort three eight compared to standard of care benchmarks, even without chemotherapy.
In cervical cancer and enrollment momentum continue for now expanded cohort two in the ongoing <unk> one.
Five four trial.
Based on FDA feedback this cohort is investigating LIFO neutral following progression on or after chemotherapy.
One therapy to support regulatory submission.
We are also excited about our next generation approaches to optimize the til therapy.
Several of these programs incorporate genetic modification utilizing the gene editing.
I think talent technology licensed from select and activate immune checkpoint proteins that inhibits anti tumor response.
Our lead candidate <unk> 4001, a PD, one and activate it til therapy studied in our first human IL.
One 201 trial in patients with previously treated melanoma or non small cell lung cancer.
Additional Canada.
The talent technology, which include multiple immune.
Immune checkpoint targets are expected to enter clinical development in 2024.
I am available during the question and answer session.
Now.
I'll hand, the call over to Mark to discuss our first half and second quarter 2020 financial results.
Thank you or predict my comments will summarize the high level financial results for the three and six months.
On June 13 2023.
More details can be found in this afternoons press release.
Well as in our SEC filings.
Our events.
<unk> hundred $17 $3 million in cash cash equivalents investments and restricted cash as of June 32023.
Compared to $478 3 million.
As of December 31st 2020.
Our use of cash during the period included the prompt consideration to acquired worldwide rights quarter looking from clean agenda, when the transaction closed in mid <unk>.
The prompt payment was fully financed with existing cash on hand of approximately $167 7 million British pounds.
Approximately 200 million U S dollars.
As well as approximately $2 4 million British pounds of approximately $3 1 million USD.
For certain quarter P&G ventures.
We have also continued to strengthen our balance sheet and remain appropriately funded as we head towards potential commercialization of <unk> later this year.
In July we raised estimated net proceeds of approximately $161 4 million from our common stock public offering.
We continue to prioritize our investments and effectively manage expenses.
Including inclusive of the proceeds from the offering our current cash position is sufficient to fund our commercial launch preparations internal manufacturing clinical pipeline expansion and operating plan until the end of 2024.
Transitioning to financial results net loss for the second quarter ended June 32023 was $106 million.
All 47 per share compared to a net loss of $99 3 million.
<unk> 63 per share for the second quarter ended June 32022.
Net loss for the six months ended June 32023 was $213 3 million.
All 98 per share compared to a net loss of $191 million.
$1 21 per share for the same period ended June 32000 troops.
Following the completion of the <unk> acquisition in May we recorded revenue for the first time in the second quarter and anticipate significant improvement new forecourt looking to begin after the launch of iPhone. So.
Revenue for the second quarter and six months ended June 32023 was zero point $2 million comprised of product sales of <unk>.
There was no revenue for the second quarter and six months ended.
June 32020.
Cost of sales for the second quarter and six months ended June 32000, 2003 was $2 1 million daus.
Cost of sales related entirely to <unk>, including $1 9 million of noncash.
Noncash comp.
Amortization of the acquired intangible assets of developed technology.
No Costar for review for the second quarter and six months ended June 32012.
Research and development expenses were $85 8 million for the second quarter ended June 32023.
Increase of $12 9 million.
Compared to $73 4 million.
Jim.
On June 13 2020.
Research and development expenses were $169 1 million for the six months ended June .
<unk> 2023, an increase of $27 4 million compared to $141 7 million for the same period ended June 32020.
The increases in research and development expenses over the prior year. Prior years were primarily attributable to growth of internal research and development team.
CET related and internal research programs cost and initiation of our phase III.
Key events tier one trial, which were partially offset by a decrease in stock based compensation expense.
Selling general and administrative expenses were up $21 9 million for the second quarter ended June 32023.
Trees are $4 4 million compared to $26 3 million.
For the same period ended June 32020.
Selling general and administrative expenses were $15 million for the six months ended June 32023, an increase of only $3 million compared to $49 7 million for the same period ended June 32022.
The decrease in selling general and administrative expenses in the second quarter of 2000, <unk> compared to prior year zero failures was primarily attributable to the disposition of expenses associated with the <unk> acquisition.
The transaction terms.
The increase in other costs are explained by the timing of the spend compared to the prior year program, including marketing advertising licensing and insurance costs, partially offset by cost associated with the growth in the overall business.
The minor increase in selling general and administrative expense in the first outflows constitute 93 compared to the prior year period.
It's primarily attributable to growth of internal general and administrative and commercial teams.
Offset by a decrease in legal fees and other costs.
As of June 32023, there were approximately $224 7 million common shares outstanding.
I'll now hand, the call back to the operator to kick off a fixture in this session.
Thank you.
To ask a question. Please press star one one on your telephone and wait for your name to be announced.
To withdraw your question. Please press star one again, please standby, while we compile the Q&A roster.
Our first question comes from the line of Peter Lawson with Barclays. Your line is now open.
Great. Thank you for taking my question, maybe a quick question.
Just around I guess.
Just to wrap up.
Cash runway.
You said kind of into the end of 'twenty four.
I feel the prior guidance was only 25%.
What if I got that right and two if there are any changes.
That you were thinking through.
Thank you for the thanks for the question.
We were guiding before and in the first half of 2020 form with the recent.
100, <unk>, let's say 100.
52 million of net proceeds we are adding two quarters. So that's why we are commencing around into towards the end of <unk>.
24 of course this will depend also on the revenue generated by.
Protein on one side and they're literally salons, the oversight, but let's say we offered through a profit was more than what we indicated before.
Perfect. Thank you and then.
If you think about the.
The upcoming data at World lung.
Thank you.
Tell us about the number of patients in particular, I guess the follow up time.
Did we see in the abstract because since the presentation.
Yes, Peter Thats still embargoed.
Rules until next week, but there'll be I think substantial follow up in the abstract and even more follow up on the conference.
It will be.
Compared to what you see from us.
Got you.
Is that also the case in the number of patients.
Okay.
B, a strong launch and potentially better than some of the things that they had to deal with on the car Teeside, maybe just talk to that a little bit as people think about the lunch.
And then the second question is following up on the lung cancer data can you just remind us how to put into context of 47% over a response rate and first line do you want to be similar to chemo combo do you want to be better is it about durability or one time treatment can you just kind of put that in the context versus what is already out there for.
First one and that would help us see the advantages of outdoor therapy. Thank you.
Yeah My.
We do think their lunch.
The strongest.
And of course.
That's what the product you're referring to it.
As a general matter we've got.
Every stars are more lines for us and they were quite.
Quite a few launches because.
Navigable reimbursement landscape for example, you've got the Medicare or is your G. G code already established for like muscle, we've learned a lot from their their experience in terms of capacity landing site Onboarding.
Haven't had a had a target.
[noise] centers and get them up and running manufacturing capacity and so on so yes, just general matter, we anticipate a storm watch.
If I missed your point, they're going to have Jim.
Follow up with you on that.
Although lung dated I'd be looking as your benchmarks in particular for two or three a we're looking at the first two subgroups.
Call the ICI naive and the chemo refractory subgroups and then compares for those are are the keno four seven Aquino 189 trials, which showed or the 48 to 50 per cent range would that'd be worse than in seven to 11 months range. So you're looking at total plus <unk> plus chemo.
Being superior to that.
Perfect. Thank you.
And use you quoted by the way should have like you would have 47 per cent of our that's your across all three suburbs.
<unk> into two subgroups that are comparable to that is at 8.3 Frederick mentioned that during his comments earlier.
Got it thank you for clarifying that.
Thank you. Our next question comes from the lineup Tyler.
T D. Cowan your line is Nelson.
Hi, I.
The <unk>.
Let me say this all online so I'm curious what you know in reference to what K O L.
Call that you guys recently Hudson I'm curious to see what you guys exactly are doing to overcome the challenges of under education, among the physician community I guess that's.
Real estate more efficient referrals per months.
Yeah, So that one I'd, probably is Jim O'brien to speak up there and just give a little bit of summary of what we're doing to work on referral patterns.
Sure This is Jim.
60% of the patients are in the community superheroes are gonna be very important for us.
The initial months of launch here, what we're doing is taking data driven approaches to understand existing <unk> referral patterns as well as building understanding of where these patients are in the community. We'll use personal promotions I E. The sales force to go out and talk to them, but.
<unk> with a high concentration of advanced melanoma patients and then we'll use cost effective nonpersonal promotions to expand our reach and frequency to educate on light blue So among community practices.
Okay. Thanks, so much.
Thank you.
Our next question comes from the line of calling T C with bird healing is now open.
Hi, Good afternoon. Thank you for taking your questions and came back to the amount of progress. So as we're within now yeah. A number of months of unexpected approval do you have any sense of pent up demand at this stage and is there any segmentation of the patient population in the market that you're prioritized in the early portion of this launch based on patient.
Patient characteristics or things of that nature.
Yeah, Let me, let me out of your comments in the gym can jump in here, we have a pretty good sense of pent up demand, it's quite significantly run it and expanded access program, which we can which gives us some feel for how the demand is out there <unk> contact.
With all the investigators in patient advocacy groups constantly.
Jim do you want to see if you could take the rest of that question.
Sure Hi coin, we do a very robust segmentation based upon claims data here in the U S market.
So on the ATC side, we segmented based upon the volume of patients and we might Dennis Aydar top 2040, 60 et cetera, htc's as well as patients that are concentrated in the community. Because we have studied the car T market quite extensively we know that there is a concentration of patience.
At the top centers.
Sir the targets that were going for first and as we have those patients entered the treatment paradigm for light blue So we'll start to expand out into the community.
That's helpful. Thank you and then any more details you can share and how many centers are participating in this late onboarding process and can you need me to share any more details on what that process looks like for for centers.
Sure I won't be able to share the exact numbers, but I will reinforce our goal is to launch.
Launch with targeted 40 centers within three months of approval and we are on track what I will say is that there are more centres that are participating in the onboarding. So I think it is reflective about the unmet need and the excitement again amongst the a T C.
Sorry, Colin can you repeat that second question.
Just any more details you can provide on what that process looks like for centers and you know how long that might take in hell on Earth is that it.
Sure. There's some administrative things that we do like I T checks to make sure that you know the firewalls are compatible for our systems.
But the heaviest work is really uhm, our medical affairs team, which worked with dissenters on their capabilities to understand and build a workflows S. O PS make sure that order sets are are defined uhm the whole process. If a center is fully.
We engage can be a relatively short if it's you know a center that's got a lot of competing demands it could take a bit longer for senators that are entering the process right now I'm confident that they could if they are fully committed be ready for launch.
That's very helpful. Thanks for taking my question Thanks for calling.
Thank you. Our next question comes from the line of <unk> with Wells Fargo's. Your line is now open.
Hi, Thanks for taking our questions.
Was wondering if you could give some broad stroke characterization of sea I'm going B L. A for <unk> alright.
General how is the process going are you at or nearing the mid cycle review stage any concerns that might have Verizon and also when my to have a date for preapproval inspections and can think of.
Hi, Yes, where it's going well right now we lived in the mid cycle. We're past that period now things continue to go well still Nevada.
Pretty clear with us from the get go to join any major review issues. We we won't comment publicly online pre licensing inspections will occur but they are typically card later in the process is something obviously.
<unk> bear heavily for so we're working very hard on that right now, but otherwise, it's going very well be a fever engaged we've got a lot of back and forth is very productive things.
Things remain on track for the mood of the date of November 25th.
2023.
That that's terrific to hear thanks for that update uhm than I do have also a couple a couple of questions on the I have L. L. U N 202, and the typical program.
I was just wondering any additional color from your ear interaction with F D. A.
<unk> for that setting what kind of O R. R. A N D O R.
Is is the agency looking for for a typical dataset or in other words, what might be the bar for <unk> for approval and success for that trial and could you also talk about the power an assumption for this 120 patients study and where.
Other there's any opportunity for entrance update thank you.
Yeah, a friend or do you want to take that one.
Sure Yeah. Thanks, good questions. So so I think one thing that you have to keep in mind is is whenever my parking about single arm data like this one.
F D. A always suppresses the they will look the totality of the data and oncology studies, that's often times because that's the relevant points that you can actually appropriate to the address with a design like this response rate, but they will also help me to look at Theresa.
Teresa response and safety. So there is really no single there's no single number that's F. D. A will tell you. If you. If you. If you repeat that then then you you'll have yourself a game, it's really the <unk> the data and they're looking at how what you are presenting when you submit is comparing too.
Local care right now again, a for responseless that means <unk> might be might be something that they're looking at word D. You'll have a range of or or like you have definitely sore throat identity of responses and that's something that they're looking at which is exactly why we excited about the data and as you into.
Two right now was it to authenticate looks really promising and safety is obvious D of Netflix as well in a study like this with with with with a single our design you would usually not doin' interim analysis uhm, because it's really the final data that gives you the totality of data that is.
As informative you wouldn't necessarily stop based based on it and the scenery with a smaller set of fries.
Does that.
Yeah, Yeah. It does it does I was also lastly wondering are you in a position to comment whether those patients who <unk>, who had a response and <unk> uncle, leading as of the date of cut off are still I'm, calling in response.
Thanks.
Yes, I can I can respond to this but what what we shared just a short while ago was was very hot off the press. So the date of that that'd be that'd be disclosed was was basically just a couple of days prior to let me share.
So maybe that gives you a good idea on.
Let me step on that.
Got it thanks for all of the answers mmm.
Thank you.
Next question comes from the lineup Rennie Benjamin that's J M. T Securities. Your line is now open.
Good afternoon, guys. Thanks for taking the questions and congrats on the progress maybe just starting off this might be for Jim you know you you talked about the 48 T. CS <unk> about how many patients do you.
You figure each I dunno, a T C could handle in a month or not and a quarter. You know I think you mentioned that bed capacity is sufficient can you maybe help quantify what you know sufficient is according to each of these a T CS and do they do they vary significantly for example, the top 20 versus the top.
40 versus the top you know called 60 or 80 in terms of capacity or are they all right around the same.
Hi, <unk>. Thanks for the questions terrific question so.
So we've looked at both the car T market as well as our own data. What we know is that there is a concentration. So the number is gonna Bury your top centers are gonna have more patience compared to centers that are you know beyond 40 to 60, etc. Uhm.
And therefore bed capacity is gonna vary to some degree what I'm not saying is that all hospitals will always have sufficient capacity, but in general as we've engaged D. I a T C. They have reported that they would have sufficient capacity in our corporate slide deck, we provided some numbers both from.
H H S and the health data Dot Gov, which characterizes hospital capacity overall, and then our own internal team as we've been engaging with these a T. C for awhile now we engage them on the number of beds, often broken down to you know the various levels various floor.
So when I say that hospitals have sufficient capacity, it's based upon both of these data points.
Got it and just sticking with sales and marketing for a second how big is the sales and marketing team right now and and by the time November 25th comes along how how big will it be sure I won't give you a specific number but we're probably in the 30 plus range right now about half of my team.
Members come with previous cell therapy experience, including nurses and advanced nurse practitioners, who actually joined us from the a T sees themselves and have a number of very experienced nurses, who actually onboarded and help to treat patients on court T. So I've I've got a lot.
Experience on the team in terms of the Onboarding right now the existing team between commercial and medic Medical Affairs is sufficient to you know drive the onboarding process, sorry won't need to hire the actual sales team until we get a little bit closer.
Got it Okay and you know you guys provided a little bit of a goalposts for the normal. So pivotal study you know in terms of completing enrollment at the second half of.
2024 can you give us you know of any sort of assistance as to how cervical cancer trial is going and whether you know you have.
An idea as to when enrollment may complete there.
No we haven't got it on that study that obviously, we had to restart that entire program. After the approval of <unk> frontline setting. Another company said the withdrawal there'll be a <unk>. So it's it's going we we tried to leverage existing sites and it's running but it's not the type of study, where we can check enrollment right now.
We're trying to <unk> transfer in Canada now, there's this new patient populations, but created by the approach.
Got it.
It's just one final one for me you know is when you think about the next generation pills genetically modified pills, how should we be thinking about it and in terms of you know how those products exist with the you know what will hopefully be currently approved till products, you know and and how do we think about.
Candles Asian or is there a way to position those second generation drugs. So that you know both can kind of coexist in the same commercial space.
Oh, you're asking about the second generation of beyond drugs that we're developing based on the total out from a diverse we don't necessarily have to cannibalize or indications we can develop those.
Other genetically it until therapies for example into different indications, it's not like we have too much.
Watching the melanoma.
Plenty of solid tumor indications out there that looks to be promising that show.
Some signs of responsiveness, either ICI or tools are combined but the the additional efficacy to to get over the hurdle and that will be wherever focus in that necessarily not necessarily as the same medications that we will be seeking approval in or getting approval in in the near future.
Perfect. Thanks for taking my questions.
Thank you.
Our next question comes from the lineup 10 Burnett Stifel. Your line is now open.
Hi, Elizabeth town. This is kind of Nina <unk>. Thank you for thinking of a question.
And then the scenario for I'd like to know you still get <unk> melanoma patients who have already <unk> give me one and then separately like a new phone with also available in combination with <unk>.
<unk> <unk>, how do you think sushi sentence will treat you call Max will be treated email and you come in patients with a sequence of <unk> or did you think there will be situations will add up does may want to to to try to keep the team.
Hi, it's gonna be unsaid with like the new so I'm kinda combination.
So it's a it's.
It's a good question. We we will have this phase three study up and running and it's a clinical trial. So I would we anticipate majority of doctors will be wanting to treat their post P. One patients homelife leucyl commercially approved which is gonna be much more available than <unk> trial, setting. However, so instead of access to the trial or.
More.
<unk> have a deeper understanding of how I see is until the combined might be interested in use them until they I'm studying Robert.
<unk> and that's why I will have it open in the United States as well as outside the U S to drive that enrollment.
Okay understood and then Creek clarification question <unk> <unk> I'm, the kind of Guy then it's an extension for the sake of them have 2024 does it include any potential Avenue is concerned you can.
Mm mm like a new phone.
Yeah, I can help me.
<unk> without taking into account only proleukin revenue at this stage because of course, we cannot although we are very positive about their approval, we really don't want to take care of iphones Hoberman you into your accounts were telling me. Your total came back alright take into account to my protection.
Okay makes sense. Thank you so much.
Thank you.
Our next question comes from the line of S. T <unk>, Let's trust your line itself and.
Hi, guys. Thanks for taking my questions then like on my.
Pause it hadn't been for the progress to be made here first I'd like to go.
Want to direct a question of Fred primary spelled <unk> conference a couple of months ago. When we discuss centers building capacity, you mentioned that sounds <unk> building to get back to treat about 25 or more patient the month.
So I wanted to just maybe check and check back in with you on this.
Can you quantify what proportion of these 40 centers that <unk> that you're talking to it for three months up to approval gearing up the capacity to treat this.
This number of about 25 patients a month is it a majority of significant proportion are a minority and then I've got a couple more questions.
Yeah, so that Jim partially answered that question a little bit earlier. This is floyd in our desk I believe it's 538 at.
It has in it some data that we collected.
And that's with a 25 numbers coming from that I would've mentioned at the conference. When you were there Steven <unk>.
Basically the number is the average number of beds for target ATC per month suitable for <unk>, that's what the number is.
So that obviously, that's an average and you're going to have a minimum and maximum there I <unk> <unk> <unk> <unk>.
Such a clear, but that's the average week.
We have the data we're trying to keep some of the confidential because somebody this confidential sites, but the average is about 25 beds for targeting if you see per month for suitable for liberalism patiently. Jim said earlier, there can be some that are lower there can be some of the higher the big centers are gonna have more it all comes down to the amount of investment the hospital, making it it's.
B M P Court T and N told service lines.
Got it okay.
And then when you dress tested your production facility and gone full production.
About how many bags itself can you <unk>.
Pasadena.
We have we haven't disclosed how much we can manufacturing.
Called stress tests, we do today is called capacity demonstrations as part of of what we do to demonstrate to the regulatory authorities that we can manufacture and scale here and what we've done so far is consistent with movies disclosed for the site.
Sites, both I've answered on our CMO in terms of the capacities. It we're projecting for the market. So if you go to our deck and look at the number of patients, Sweden said, we could common.
Comedy that our facilities you could assume that we've got capacity that's within those boundaries are ramping up to those boundaries.
We have with the exact number Apple that's that's something that we can focus very much what I currently work with F. D. A O.
Got it okay uhm.
Uhm and then I don't know if rodgers available on the clock here, but I appreciate that hasn't been a request spent dotcom, but maybe pricing come in <unk>.
<unk>, what would be a scenario that would that would prompt the F D. A to last for a nightclub.
Hi, This is odd so thanks for the question I don't expect that F. D. A will seek any at <unk> at this point based on our as Fred mentioned earlier Nicol that'd be have a frequent interaction with the F D a and.
I'll It says routine <unk> process, nothing we have identified Oughta F. D. A sofa that would take it to add comments late late and that'd be the psycho and so I'm not expecting any any of that call at this point.
Great I liked the confidence that right and then last one if I can to defeat drinks on 401 is there any possibility of an update this year I apologize if I Miss it if you mentioned this earlier, but that's my last question. Thanks, guys.
I think I mean, I felt firstly, we have provided guidance on climbing on an upgrade from that study so I think.
We will when someone says something to take on.
Got it thanks, so much guys.
Thank you and next question comes from the lineup, Joe Kentaro, which Piper Sandler Your line is now open.
Everybody. Thanks for taking my question, maybe a couple of follow up on a couple of things that didn't cover maybe first on.
<unk> does does another F D a interaction needs to happen.
Up some things or or is the challenge simply around projecting timeline because of enrollment pace.
And then second question I'm, just wondering if you could say anything about the progress you've made until then throw one and whether you have expectations at the it they might ask for a status report of that trial ahead of the November <unk>. Thanks.
Yeah, I can take the the.
<unk>, it's more about the the size of the patient population, it's not a it's not a large patient population than it is about regulatory interactions.
You already have a lot of <unk> on that and feel pretty comfortable where we wanted that doesn't mean, we won't have additional interactions.
Leading into a potential delay there, but we need to focus right now I'm just at rolling.
With respect that <unk> remains in close contact with us about that study to make sure it's well underway and we feel quite comfortable with where we are what we disclose to them.
Did you ask about that we have given them updates.
Okay, great. Thank you for taking my question.
[noise]. Thank you.
Our next question comes from the lineup <unk>. Your line is now open.
Great. Thank you so much I had a question on elegant church you study and then just to follow up on <unk> mm mm no I'm not gonna you're gonna enter L. A P. D. L. One patients per square screen and one per cent in less than one per cent are they pretty satisfied into intercept numbers or is it all <unk>.
No. It's it's a it's gonna be a total sample size of 120, and we're going to across the two lovers.
So there's no there's no particular.
Number of you know one versus the other and that trial.
When we expect it to be relatively evenly balanced.
Okay and then.
Help us understand a little bit about proleukin acts obviously commercialization.
With <unk> given that the revenue that you recognized in a short period of time that you were L thing relative to the Cogs in just how we should think about that on a golfer basis.
So you're asking are you're asking about X U S revenues.
Without like Elizabeth.
Yeah.
Yeah.
Yeah, so probably going outside the United States is priced at relatively modest.
Numbers right now and the sales were not particularly high. So I you know that that's not something we look at it as a major revenue driver for us.
That's what you're asking now what part launch a light blue so that could become more significant but it's still a lot different outside the U S. A N as in the U S.
<unk>.
But it still on its own crap.
<unk>.
Outside the U S as a profitable you.
I don't know, it's it's a it can make you can make a profit on the outside of the U S. But it's nowhere near like between nice days.
Alright, thank you.
Thank you.
Alright.
Comes from the lineup Kelsey Goodwin <unk>. Your line is now open.
Oh.
Thanks for taking my question I guess first could you just remind us maybe of the efficacy bar in cervical cancer kind of giving me evolving landscape that that that you mentioned and especially since the last time, we saw a data cut there and then maybe just to confirm based on your interactions with the F D, a or a <unk> or leaning towards the label.
<unk> the pool data is cohort too and for them and that's it for me. Thank you.
While I take the second four then I'll.
Take the first part.
Yes, the F D. A has given a favorable feedback including to rebuild medium on the full data and so yes. We do continue to think that there's a possibility we can get that on the label to a good possibility to watch some indication date on the label.
That's something we're working towards always perfect you Wanna take a question about the bar for a service.
The <unk> the bars no.
Where we are right now where we're basically similar to how are Ya.
This happened and lung cancer.
Check my numbers moved into hotline in combination with kind of chemo now the post P D one and <unk> I.
I think it was wide open again the data that are available from times square folks more than looking secondhand third line therapy for cervical cancer with with other chemotherapy attacks, either tomorrow or other combinations were pretty dismal with with <unk> ordered the scene.
Between three and an email <unk> medical needs.
Alright, thank you.
Thank you.
And I'm currently showing no further questions at this time I'd now like to turn the call back over to Fred vote for closing remarks.
Thank you again for joining the identify therapeutics second quarter of 2023 financial results in corporate updates conference call.
Exciting starting in 2023 with the acceptance of the <unk> includes the Proleukin agreement important updates from lung cancer was delivering RMT regulatory commercial manufacturing and played one afterwards.
I'm grateful for the patients physicians and regulators as well as our employees and cross functional teams in advancing our mission.
Global leader until therapy.
I would also like to thank our shareholders covering animals for their support.
Please feel free to reach out to our Investor relations team for follow up thank you.
This concludes today's conference call. Thank you for joining you may now disconnect.
[music].