Half Year 2022 Adaptimmune Therapeutics PLC Earnings Call
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Operator: Good morning, everyone.
Good morning, everyone and welcome to the adapt communes Q2 financial and business update conference call I would now like to turn the meeting over to Juli Miller. Please go ahead Mr. Miller.
Operator: Welcome to the Adaptimmune's Q2 Financial and Business Update conference call.
Operator: I would now like to turn the meeting over to Juli Miller.
Operator: Please go ahead, Ms. Miller.
Juli Miller: Good morning.
Good morning, and welcome to adapt to me on this conference call to discuss our second quarter 2022 financial results and business update.
Juli Miller: Welcome to Adaptimmune's conference call to discuss our second quarter 2022 financial results and business update.
Juli Miller: I would ask you to review the full text of our forward-looking statements from this morning's press release.
I would ask you to review the full text of our forward looking statements from this morning's press release.
Juli Miller: We anticipate making projections during this call and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC.
We anticipate making projections during this call and actual results could differ materially due to several factors, including those outlined in our latest filings with the SEC.
Juli Miller: Adrian Rawcliffe, our Chief Executive Officer, and Gavin Wood, our Chief Financial Officer, and Dennis Williams, our Senior Vice President of Late Stage Development and Regulatory Affairs, are here with me for the prepared portion of the call.
In Rockford, our Chief Executive Officer, and Gavin Wood, our Chief Financial Officer, and Dennis Williams, Our senior Vice President of late stage development and regulatory affairs are here with me for the prepared portion of the call. Other members of our management team will be available for Q&A with that I'll turn the call over to Adrian.
Juli Miller: Other members of our management team will be available for Q&A.
Juli Miller: With that, I'll turn the call over to Adrian Rawcliffe at.
Well cliff add.
Thank you Judy and thank you everyone for joining us.
Adrian Rawcliffe: Thank you, Juli, and thank you, everyone, for joining us.
In 2022, we're focused on four things to drive value for all stakeholders.
Adrian Rawcliffe: In 2022, we're focused on four things to drive value for our stakeholders. One, submitting the BLA for a FamaCell. It's our first-generation MAGE A4 targeted product.
One submitting the BLA for our find myself, so first generation <unk> <unk> targeted product.
Two building out the mortgage a full franchise.
Adrian Rawcliffe: Two, building out the MAGE A4 franchise.
Adrian Rawcliffe: Three, scaling up our manufacturing capabilities.
By scaling up our manufacturing capabilities.
Adrian Rawcliffe: And four, progressing our allogeneic platform.
For progressing our allogeneic platform.
And we're building a company to deliver our long term vision of multiple marketed cell therapies for cancer, including other generic therapies.
Adrian Rawcliffe: And we're building a company to deliver a long-term vision of multiple marketed cell therapies for cancer, including allogeneic therapies.
Adrian Rawcliffe: In the near and mid-term, we're focused on our MAGE A4 franchise.
In the near and mid term, we're focused on J full franchise.
Adrian Rawcliffe: We are on track to submit our first BLA for ephamysal for the treatment of synovial sarcoma, in Q4 and Dennis is going to update you on our progress towards submission.
We're on track to submit our first BLA for a fan myself for the treatment of synovial sarcoma in Q4.
Dennis is going to update you on our progress towards submission.
If approved this will be the first commercially available engineered TCR cell therapy for solid tumors.
Adrian Rawcliffe: If approved, this will be the first commercially available engineered TCR cell therapy for, solid tumours.
Adrian Rawcliffe: Adaptimmune has received tremendous support for ephamysal from healthcare providers, clinical centres of excellence and from patient groups, for which we are incredibly grateful as patients are at the heart of every step that we take.
Dr. <unk> has received tremendous support from our by myself from health care providers clinical centers of excellence and from patient groups for which we are incredibly grateful as patients are at the heart of every step that we take.
Adrian Rawcliffe: And we're honoured to announce that in September, we will accept the Vision of Hope Award from the Sarcoma Foundation of America.
And we're honored to announce that in September we will accept the vision of Hope award from the Sarcoma Foundation of America.
Adrian Rawcliffe: In June, we presented data at ASCO that further demonstrated the potential of ephamysal in synovial sarcoma and at CITOS this fall, we plan to present another update from Cohort 1 of the Spearhead 1 trial.
In June we presented data at Ash go further demonstrated the potential of a fan myself in synovial sarcoma and of seats of this fall we plan to present another update from cohort one of the spearhead one trial.
Adrian Rawcliffe: The recognition from the Sarcoma Foundation and the increasingly complete and compelling data presented over the last two years is a testament to the potential of ephamysal for patients with this rare and difficult to treat cancer.
The recognition from the soft kind of a foundation.
And the increasingly complete and compelling data presented over the last two years is a testament to the potential of <unk> for patients with this rare and difficult to treat cancer.
The promise of BLA is only the beginning the submission and the focus launch we are planning is an opportunity for it that to me and to develop and to exercise our commercial manufacturing and logistics infrastructure.
Adrian Rawcliffe: The ephamysal BLA is only the beginning.
Adrian Rawcliffe: The submission and the focus launch we are planning, is an opportunity for Adaptimmune to develop and to exercise our commercial, manufacturing and logistics infrastructure. This is important to both our near and longer-term success as we aim to commercialise multiple cell therapies for cancer with these capabilities.
And this is important to both our near and longer term success as we aim to commercialize multiple cell therapies for cancer with these capabilities.
Beyond that by myself with design, the nextgen therapy to be more potent and to deliver responses across a range of solid tumors. In addition to sarcoma.
Adrian Rawcliffe: Beyond ephamysal, we've designed a next-gen therapy to be more potent and to deliver responses across a range of solid tumours in addition to sarcoma.
We've been investigating the enhanced potency of this next gen <unk> product and our <unk> family of trials.
Adrian Rawcliffe: We've been investigating the enhanced potency of this next-gen CD8 product in our SURPASS family of trials. At last year's ESMO, we presented clinical data from our signal-finding Phase 1 SURPASS, trial with this CD8 product. In addition to sarcoma, we reported responses in ovarian, head and neck, esophagogastric junction, or EGJ, and bladder cancers from the 22 evaluable regions. Based on positive signals in certain gastroesophageal cancers, we initiated the Phase 2 trial SURPASS 2, targeting esophageal and EGJ cancers last year.
At last year's ESMO, we presented clinical data from a signal finding phase once the posture with the CDI product.
Adrian Rawcliffe: And based on the, positive signal we saw in ovarian cancer, we are planning to initiate SURPASS 3 later this year.
In addition to sarcoma, we reported responses in ovarian head and neck esophageal gastric junction R J and bladder cancers from the 22 Evaluable patients.
Based on positive signals in certain gastroesophageal cancers, we initiated the phase II trial as opposed to targeting a sofa, Gilles and EG J, Kansas last year.
And based on the positive signal we saw in ovarian cancer, we are planning to initiate the path. Three later this year.
We're working closely with advisors and Kols from the Gynecologic Oncology Group Foundation or <unk>.
Adrian Rawcliffe: We're working closely with advisors and KOLs from the Gynaecologic Oncology Group Foundation, or GOG, a preeminent advisory group for clinical trials in gynaecologic oncology, on the design and execution of this Phase 2 trial.
A pre eminent advisory group for clinical trials in gynecological oncology on the design and execution of this phase III trial.
This September .
Adrian Rawcliffe: This September, at ESMO, Dr. David Hong of the MD Anderson Cancer Center will present updated data from the Phase 1 signal-finding SURPASS trial in an oral presentation. Data at ESMO will include 44 patients who were treated by the time of the data cut, and 43 patients will be evaluable for efficacy.
Good.
Dr. David Hong of the MD Anderson Cancer Center will present updated data from the phase one signal finding some Pos trial in an oral presentation.
Data at ESMO will include 44 patients who were treated by the time of the data cut of 43 patients will be evaluable for efficacy.
Okay.
On the first day of asthma September 9th we will host a live virtual event to discuss these data and also Pos family of trials and we're thrilled that doctor carefully more has agreed to speak with our event she's an associate professor of gynecological oncology at the University of Oklahoma College of Medicine.
Adrian Rawcliffe: On the first day of ESMO, September 9th, we will host a live virtual event to discuss, these data and our SURPASS family of trials.
Adrian Rawcliffe: And we're thrilled that Dr. Kathleen Moore has agreed to speak at our event. She's an Associate Professor of Gynaecologic Oncology at the University of Oklahoma College of Medicine, and is a member of the GOG Investigator Council.
Adrian Rawcliffe: Council.
It is a member of the <unk> investigator Council.
Adrian Rawcliffe: Dr. Moore will provide her perspective on the potential of cell therapy in solid, tumours, including her experiences with patients with ovarian cancer, treated in our Phase 1 surpass trial.
Dr Mobile prescribed provide her perspective on the potential of cell therapy in solid tumors, including her experiences with patients with ovarian cancer treated in our phase <unk> trial.
Adrian Rawcliffe: Now I want to emphasise the measures we're, taking to ensure long-term success, and Gavin will provide a more detailed update later in the call.
Now I want to emphasize the measures we're taking to ensure long term success and Gavin will provide a more detailed update later in the call.
Adrian Rawcliffe: As we've previously stated, Adaptimmune is funded into early 2024, and we will continue to prioritise our spend and ensure success across our four focused areas that I outlined earlier.
As we've previously stated adapt to meet its funded into early 2024.
We will continue to prioritize our spend and ensure success across our four focus areas that I outlined earlier.
We have an experienced management team who have gone through multiple economic cycles, and we are leveraging our collective experience to continually assess and prioritize investment.
Adrian Rawcliffe: We have an experienced management team who have gone through multiple economic cycles, and we're leveraging our collective experience to continually assess and prioritise investment. We've already implemented cost containment measures, including delaying or stopping activities as part of our continuous portfolio review, as well as deferring and cutting spend, and we are carefully monitoring market conditions.
We've already implemented cost containment measures, including delaying or stopping activities as part of our continuous portfolio review as well as deferring and cutting spend and we are carefully monitoring market conditions.
Adrian Rawcliffe: And whilst we've been disciplined about spending, we also don't want to delay our progress in the critical areas. Therefore, we will continue to pragmatically invest in our four focus areas and enhancements to the operations that support these, including continuing to build our commercial and manufacturing capabilities.
And whilst we're being disciplined about spending we also don't want to delay our progress in the critical areas.
Therefore, we will continue to pragmatically invest in our four focus areas and enhancements to the operations that support these including continuing to build our commercial and manufacturing capabilities.
We are well positioned to weather the current economic environment and emerge as one of the few cell therapy companies with commercial products and the exciting clinical pipeline against solid tumors.
Adrian Rawcliffe: We are well positioned to weather the current economic environment and emerge as one of the few cell therapy companies with commercial products and an exciting clinical pipeline against solid tumours.
We are committed to maximizing the probability of near and long term success by managing costs and prioritizing appropriately.
Adrian Rawcliffe: We're committed to maximising the probability of near and long-term success by managing costs and prioritising
Adrian Rawcliffe: appropriately.
And now I'd like to turn it over to Dennis for an update on the BLA for our pharma so Dennis.
Adrian Rawcliffe: And now I'd like to turn it over to Dennis for an update on the BLA for
Thanks, Ed.
Getting the BLA for <unk> in the fourth quarter of this year as our top priority.
Adrian Rawcliffe: a Famicel.
We have made great progress and remain on track to meet this important milestone.
Dennis Williams: Dennis?
We have scheduled our pre BLA meeting with FDA and given the timing for this meeting we plan to provide a brief update during our third quarter earnings call.
Dennis Williams: Thanks, Ed.
There've been a number of important achievements in the first half of this year.
Dennis Williams: Submitting the BLA for a Famicel in the fourth quarter of this year is our, top priority.
Our vector manufacturing partner will Tony biotech <unk>.
Dennis Williams: We have made great progress and remain on track to meet this important milestone.
Define us that our new commercial facility has been released for GMP manufacturer.
Dennis Williams: We have scheduled our pre-BLA meeting with FDA, and given the timing for this meeting, we plan to provide a brief update during our third quarter earnings call. There have been a number of important achievements in the first half of this year. First, our vector manufacturing partner, Multani Biotech, notified us that their new commercial facility has been released for GMP manufacture. Multani Biotech has been our external vector provider throughout Spearhead One. The GMP release of this manufacturing facility was an important milestone, and it enabled the Vector Process Performance Qualification, or PPQ, to initiate, and Vector PPQ is presently ongoing.
Well, Tony biotech has been our external vector provider throughout spearhead one.
The GMP release of this manufacturing facility was an important milestone and it enabled the vector process performance qualification or PQ.
To initiate and Victor <unk> is presently ongoing.
Dennis Williams: Second, method validation for commercial T-cell lot release assays, including potency assays, is progressing well, and the T-cell process performance qualification is planned to initiate in the near term.
Second method validation for commercial T cell lot release assays, including potency assays is progressing well.
And the T cell process performance qualification is planned to initiate in the near term.
Dennis Williams: Third, Spearhead One Cohort One is the primary clinical evidence supporting an efficacy claim in the BLA, and the primary, analysis and reporting of Spearhead One Cohort One is complete. Supportive clinical analyses and reporting are in progress.
Third spearhead one cohort one is the primary clinical evidence supporting an efficacy claim in the BLA.
And the primary analysis and reporting of spearhead one cohort one is complete.
Supportive clinical analysis and reporting our progress.
Dennis Williams: Finally, other key initiatives are progressing well. As discussed previously, the Pre-Market Approval, or PMA, application for MAJ-4 Companion Diagnostic is a modular submission.
Finally, other key initiatives are progressing well.
As discussed previously the pre market approval or PMA application for me Jay for companion diagnostics is a modular submission.
Dennis Williams: Submission.
Two of the four total module of the PMA submission have now been submitted to FDA for review.
Dennis Williams: Two of the four total modules of the PMA submission have now been submitted, to FDA for review. Our partner, Agilent, is planning to submit the final module at the same time that we submit the BLA for efamicel.
Our partner agile and is planning to submit the final module at the same time that we submit the BLA for <unk>.
We're very proud of the work we've done to advance a pharma sell to where it is today.
Dennis Williams: We are very proud of the work we've done to advance efamicel to where it is today. Our team is dedicated to this product and is galvanized by the potential efamicel has to impact the lives of people living with synovial sarcoma.
Our team is dedicated to this product and is galvanized by the potential of famous cell has to impact the lives of people living with Sanofi Youll sarcoma.
Dennis Williams: If approved, efamicel will be the first new therapy approved and labeled in the United, States for the treatment of synovial sarcoma in nearly a decade.
If approved <unk> will be the first new therapy approved in labeled in the United States for the treatment of synovial sarcoma in nearly a decade.
And it would be the first marketed engineer.
Dennis Williams: It would be the first marketed engineered TCRT cell therapy for a solid tumor, which would be a milestone for adaptamine patients and healthcare more broadly.
Engineered TCR T cell therapy for solid tumor, which would be a milestone for adapting patients and health care more broadly.
Dennis Williams: And now we'd like to turn it over to Gavin for a financial update.
And now I would like to turn it over to Gavin core financial update Kevin.
Thank you Dennis.
Gavin Wood: Gavin?
At the start of the second quarter, our total liquidity was $258 million.
Providing us with a cash runway into early 2024.
Gavin Wood: Thank you, Dennis.
Our cash runway as a result of the successful financing business development actions in the last 24 months.
Gavin Wood: At the start of the second quarter, our total liquidity was $258 million, providing us with a cash runway into early 2024. Our cash runway is the result of successful financing and business development actions in the last 24 months, the most recent of which was an upfront payment late last year of $150 million as part of our strategic collaboration with Roche Genentech.
The most recent of which was an upfront payment late last year of $150 million.
Our strategic collaboration with Roche Genentech.
Gavin Wood: We expect to continue to use this combination of BD and equity to finance the company over the coming years.
We expect to continue to use as combination of BD and equity to finance the company over the coming years.
Gavin Wood: The sector is going through a period of time when the capital markets are challenging. It's our responsibility to respond to these difficult markets and to position ourselves to take advantage of the opportunities that will arise when the markets improve. We are drawing on the collective experience of our executive team, board of directors and advisors who have successfully managed through multiple economic cycles as we continue to prudently evaluate and rigorously manage our cost base to enable near and long-term successes.
Thanks, guys going through a period of time when the capital markets are challenging.
So our responsibility to respond to these difficult market and so this assumes ourselves to take advantage of the opportunities that will arise when the markets improve.
George on the collective experience of our executive team board of directors and advisors.
Successfully managed through multiple economic cycles as.
As we continue to prudently evaluate and rigorously manage our cost base to enable near and long term successes.
Gavin Wood: I'll take a moment to look at our cost base in two verticals, operating expenses and capital investments.
I'll take a moment to look at our cost base into verticals.
Gavin Wood: Turning to operating expenses first, the DAV team has always had a robust resource allocation methodology.
Operating expenses and capital investments.
Turning to operating expenses first.
That thing has always had a robust resource allocation methodology.
We remain committed to making disciplined investments in the focus areas at earlier for example in submitting the BLA as well as focusing on our <unk> family of trials.
Gavin Wood: We remain committed to making disciplined investments in the focus areas as set out earlier, for example in submitting the BLA as well as focusing on our surpassed family of trials.
However, as we look to extend our cash run rate in the current environment.
Gavin Wood: However, as we look to extend our cash runway in the current environment, we recently undertook a detailed review of our cost base and implemented a range of cost-cutting initiatives. As part of this strategic review, we made appropriate decisions to delay certain activities. For example, as you may have seen in this morning's press release, we are postponing filing and IND for our new next generation cell therapy that we are developing in collaboration with, Noel Immune.
We recently undertook a detailed review of our cost base and implemented a range of cost cutting initiatives.
As part of the strategic moves we made decisions to slide six and activities.
For example, as you may have seen in this morning's press release.
Postponing finding in R&D for next generation cell therapy that we are developing in collaboration with Noel meeting.
Gavin Wood: We continue to assess options to reduce costs still further and I'll update you on these during the Q3 earnings call.
We continue to assess options to reduce costs still further.
I'll update you on.
<unk> joined the Q3 earnings call next lets look at the capital investments, we're making to ensure our long term success.
Gavin Wood: Next, let's look at the capital investments we're making to ensure our long-term success. Firstly, we're increasing the GMP manufacturing space in our drug product manufacturing facility in the Navy Yard in Philadelphia to support our current clinical trials and future commercial products.
Firstly, we are increasing the GMP manufacturing space in other drug product manufacturing facility in the Navy yard in Philadelphia to support our current clinical trials and future commercial products.
And secondly, we're nearing completion of the three tests of a new manufacturing facility in the U K.
Gavin Wood: And secondly, we're nearing completion of the fit-out of a new manufacturing facility in the UK to support our wholly owned allogeneic therapy targeting MAGE A4.
Our wholly owned allogeneic therapy targeting MAGE <unk>.
Gavin Wood: With that, I'll turn over to Ad for a few closing remarks before Q&A.
With that I'll turn over to add for a few closing remarks before Q&A at thanks.
Adrian Rawcliffe: Ad?
Thanks, Kevin.
I also emphasize four key points from today's call.
Adrian Rawcliffe: Thanks, Gary.
One we're focused on creating value with a major franchise for the near and long term.
To the BLA for <unk> myself as I said at the beginning we will use the submission and the focus launch to ensure future commercial launches will be even more successful.
Three we are building a company that can support our long term vision of multiple market itself therapies for cancer, including allogeneic therapies.
Before we have an experienced management team and we are carefully managing investments for near and long term success and with that I'll turn it over for Q&A operator.
Adrian Rawcliffe: I want to emphasize four key points from today's call.
Adrian Rawcliffe: One, we're focused on creating value with our May J4 franchise for the near and long term.
Yes. Thank you we will now take questions from the telephone lines do you have a question and you're using a speaker phone. Please lift your handset before making your selection.
A question. Please press star one on your devices Keypad you may cancel your question at any time by pressing star too. So please press star one at this time, if you have a question and there will be a brief pause while the participants register and we thank you for your patience.
Adrian Rawcliffe: Two, the BLA for Afamysl is only the beginning.
So first question is from Tony Butler from Roth Capital. Please go ahead.
Yes, thanks very much I appreciate the color two very brief questions. One is on surpass too.
I think.
Controls.
Dot Gov has.
About 33 sites that are enrolling patients. My question is around how well is enrollment going because a number of those sites are not yet enrolling a couple of drops if you could just frame that within the context of.
The current trial sites. That's question. One question. Two is also I think there was at least.
Yes.
Slide deck, that's maybe a bit.
But there was also the notion of beginning a phase one trial with one of the til programs is that also being pushed out.
His focus.
It's clearly a four franchise.
And the completion of the BLA file thanks very much.
Adrian Rawcliffe: We will use this submission and the focus launch to ensure future commercial launches will be even more successful.
Adrian Rawcliffe: Three, we're building a company that can support our long-term vision of multiple marketed self-therapies for cancer, including allogeneic therapies.
Adrian Rawcliffe: And four, we have an experienced management team and we are carefully managing investments for near and long-term success.
Okay. Thanks, Tony.
Adrian Rawcliffe: And with that, I'll turn it over for Q&A.
I'm going to take those questions in reverse order just confirm no. The til program is not being.
Operator: Operator?
Not being delayed.
Operator: Yes, thank you.
And I'll ask Dennis to talk to the.
Yes.
The path too.
Yeah sure. Thank you for the question.
You are correct.
Not all of the sites at the moment are actively open for screening.
Rolling out sites.
Periodic basis, but the trial is <unk>.
Open for recruitment I don't think we're commenting at this point about where.
Individual patients are in that trial, but it is recruiting at this point presently.
Thanks, Tim I appreciate it.
Thank you. Our next question is from Marc Frahm from Cowen and company. Please go ahead.
Operator: We will now take questions from the telephone lines.
Operator: If you have a question and you're using a speakerphone, please lift your handset before making your selection.
Hi, good morning, guys.
Operator: If you have a question, please press star 1 on your device's keypad.
Operator: You may cancel your question at any time by pressing star 2.
Good for you guys.
Mark.
Operator: So please press star 1 at this time if you have a question, and there will be a brief pause while participants register, and we thank you for your patience.
So regarding the ESMO presentation.
What are the speed of tumor types that we would likely to see there.
Tony Butler: So first question is from Tony Butler from Roth Capital.
Would there be enough patients to make additional go or no go decision.
Tony Butler: Please go ahead.
How many patients do you think.
Need to fit within the tumor type to make to make those kind of way.
Tony Butler: Yes, thanks very much.
Tony Butler: I appreciate the caller.
Decisions.
Tony Butler: Two very brief questions.
Yes.
Tony Butler: One is on Surpass 2.
I'm going to ask Elliot to take that question.
Tony Butler: I think ClinTrials.gov has about 33 sites that are enrolling patients.
Tony Butler: The question is around how well is enrollment going because a number of those sites are not yet enrolling, a couple have dropped.
Elliot.
Tony Butler: If you could just frame that within the context of the current trial sites, that's question one.
Yeah, Hi, thanks, Thanks for the question so.
Tony Butler: Question two is also I think there was, at least it's in this past slide deck, this may be a bit old, but there was also the notion of beginning a Phase I trial with one of the TILD programs.
Tony Butler: Is that also being pushed out as focus is clearly on the MAGE A4 franchise and the completion of the BLA file?
Tony Butler: Thanks very much.
ESMO you can expect for the update.
And the data to be across a range of tumor types that are included in the trial.
As was noted by add on in the press release, there will be 44 patients.
Included in the data cut in 43 of those.
We'll be Evaluable for response.
I don't think were guiding specifically as it relates to exactly how many in each tumor type, but I think you can expect to see data.
Data across the range of the tumors that are included in the study.
Okay.
Adrian Rawcliffe: Okay, thanks, Tony.
Adrian Rawcliffe: I'm going to take those questions in reverse order, just confirm no, the TILD program is not being delayed, and I'll ask Dennis to talk to the Surpass 2.
One more question on the BLA submission.
Dennis Williams: Yes, sure.
When do you expect to complete the validation of bookings.
Dennis Williams: Thank you for the question.
Okay.
Dennis Williams: You're correct, not all the sites at the moment are actively open for screening.
And you'll have it previously at pre BLA meeting before this happened.
Got it yes.
Dennis Williams: We're rolling out sites on a periodic basis, but the trial is open for recruitment.
Dennis Williams: I don't think we're commenting at this point about, you know, where individual patients are in that trial, but it is recruiting at this point presently.
Yes sure.
Dennis Williams: Thanks, Dennis.
Essentially that T cell potency assay that.
Dennis Williams: Appreciate it.
I mentioned.
It is actually in progress of being validated like imminently.
Dave.
Operator: Thank you.
So the pre BLA meeting as is scheduled is mentioned as scheduled.
Operator: Our next question is from Mark from Cohen & Company.
We have been using a probably circle back we've been using this potency assay.
Throughout development for this product.
And certainly that assay was used all through the spirit one clinical trial.
We have optimized the assay to be more appropriate for a commercial lot release assay. So.
So this was sort of supplementary validation work that was completed in advance of T cell <unk>, which I mentioned is starting imminently.
Great very helpful. Thank you guys and congratulations on the progress.
Thank you. Thank you.
Thank you next question is from Peter Lawson from Barclays. Please go ahead.
Operator: Please go ahead.
Hi, Good morning. This is Alex on for Peter Thank you for taking our question.
Ernesto Rodriguez: Good morning, guys.
Ernesto Rodriguez: This is Ernie Rodriguez for Mark.
Ernesto Rodriguez: So regarding the ECMO presentation, what are the spread of tumor types that we're likely to see there?
Ernesto Rodriguez: And would there be enough patients to make additional go or no-go decisions?
Just on surpass three any insights you could give us around trial design and execution. How many patients you are planning to enroll and is it going to be platinum in eligible patients.
And if youre planning any combination studies here as well thank you.
So I'll just say that we have.
Haven't we haven't made public any details of the trial design et cetera.
But if you were looking for an update on the <unk> family of trials, then I would suggest that a webcast on the <unk> of September .
It would be a good place to.
To start.
Yes.
Okay, Great and just just another question quickly given the cost containment measures. You mentioned, you expect youll be able to drive both surpassed two and three programs forward in parallel or do you expect you might need to maybe prioritize one over the other and the near.
Near to medium term.
We expect to be able to develop the <unk> family of trials with within the envelope.
Our run rate guidance indicates and.
I think.
And that includes to foster and spas III and I'll point, you back to the update that we plan on giving on surplus in the data.
On the first day of asthma September month.
Alright, thank you.
Thank you.
Thank you. Our next question is from Jonathan Chang from SVP Leerink. Please go ahead.
Ernesto Rodriguez: How many patients do you think you need to touch within a tumor type to make those kind, of decisions?
Ernesto Rodriguez: Thanks.
Elliot Norry: Yeah.
Hi, guys. Thanks for taking my questions. First question can you discuss how we should be thinking about duration of clinical benefit with the next Gen <unk> program and the surpass studies.
Elliot Norry: So I'm going to ask Elliot to take that question.
Elliot Norry: Elliot?
So.
Elliot do you have any comments on that.
At this point.
Elliot Norry: Yeah.
Hi, Jonathan what I would say is.
Elliot Norry: Hi.
The update.
Two the surpass program at ESMO will include data Andre our ability of response I don't think we'll providing any guidance as it relates to that at this time.
So I would look forward to the.
Elliot Norry: Thanks.
The data that's going to be presented at ESMO, which which will include response rate and durability of response.
Elliot Norry: Thanks for the question.
Got it are you able to maybe provide some thoughts on what the reasons the reasons for confidence are.
Elliot Norry: So at ESMO, you can expect for the update in the data to be across the range of tumor, types that are included in the trial.
That youll be able to achieve durable clinical benefit.
Yes.
Yes.
<unk>.
I'll take I'll take the first I'll take the first stab at that passed earlier I think the reasons to durable clinical benefit.
Elliot Norry: As was noted by Ed and in the press release, there will be 44 patients included in the, data cut, and 43 of those will be available for response.
Would start with the data from the spearhead one trial, which clearly shows that in a solid tumor cell therapy can deliver.
Durable responses that are of significant benefit to patients in that form the basis of the BLA.
File later on this year I think the purpose of the second generation was to extend the opportunity in cell therapy to broader tumor types.
Elliot Norry: I don't think we're guiding specifically as it relates to exactly how many in each tumor, type, but I think you can expect to see data across the range of the tumors that are included in the study.
What were.
Dealing with.
The <unk> trial, and then the <unk> family of trials.
Apart from that so I'm going to have.
And all the other technical discussions that we've had over the years I would point you to the.
To the.
Data update in September just maybe one thing to point to.
Yes, I think the.
The fact that we are seeing.
Robust responses.
In <unk>.
Very late stage patients in the <unk>. One trial is also reason for confidence so the clinical benefit that can be achieved.
The right patient populations.
With these therapies.
And with that I will defer to September nine.
Got it.
Maybe just a couple.
Higher level questions for you guys.
And that is how does <unk> compare to <unk> four.
As a TCR target and then also how do you guys think about the interplay between.
TCR bi specifics and TCR cell therapies. Thank you.
So I'm going to ask.
J P <unk> CFO to talk about.
And I think when it comes to frame and May take for obviously.
We have.
So it's about the targets and that's obviously significant overlap in certain tumors.
Prime program that we have is obviously partnered with GSK say that suddenly we cant do independently from then.
<unk>, obviously made a four is within our control so I think that different targets and different Tcl us.
And I think that's really we will have to see how those play out in the clinic.
We optimize our Tcs very specifically.
With us we do that.
Optimization for every single program and I can't comment on other People's Tcs in relation to <unk>.
And.
That base well presented targets in solid tumors and I'm sure there will be clinical successes.
Okay.
And then when it comes to spin.
Specifics verses cell therapies.
I think pricing constant basis as it depends on the target density and how well that works with the T cells say.
Having the TCR actually inside the T cell versus having a bridge in between I think again, we will see how that plays out with the number of peptides on the surface of the cells and then they will say I think the tumor microenvironment plays a big role there as well.
Again, I don't think there's anything I can necessarily say head because we only deal with cell therapy, rather than by specifics ourselves.
Got it thanks for taking my questions.
Thanks, Thanks, a lot.
Next question is from Michael Smith. Please state your company and proceed with your question.
Hi, This is Paul on for Michael Guggenheim. Thanks for taking my question. So on surpass we thought that you've opened the Nemo combination arm has that begun recruiting and when can we potentially see clinical data and is there any waiting.
For that arm for patients who could be PD, one responses or plans to report patients by PDL one expression level. Thank you.
Elliot.
Yes so.
Thanks, I can confirm that that arm is open and enrolling patients.
Being rolled out to the surpass study sites.
As quickly as we can do.
We are measuring.
PD one expression at baseline so we will be able to provide insights as it relates to baseline PD one expression in relation to response.
Great. Thank you.
Thank you. Our next question is from Mara Goldstein from Mizuho Securities. Please go ahead.
Oh, Thanks, very much just a couple quick ones on just with respect to the cost containment effort I think I saw the last figure that I saw and.
Your deck is that you have about 500 ftes across the various manufacturing facility and is that still the case, even with these cost containment issues and then.
Just on on spearhead one I know you've spoken to the primary clinical support for the BLA filing of <unk>, one, but can you speak to what other data you plan to submit to support the filing.
Hello.
So.
Scott, It's Kevin speaking.
It was running a little over 500 now so we've begun to ramp up on the commercialization and also to complete the BLA submission.
That's just sort of broadly the number we're targeting.
And then on the BLA.
Dennis.
Yes sure.
So there is a lot of things that we would use to support the clinical dossier that would include things like integrated a pooled efficacy and safety analysis, some of which we showed back in <unk>, but there are more than that we have a number of exposure response analyses.
Non compartmental analysis taking into.
<unk> exposure and its relationship to efficacy and things of this nature of that.
To help supplement the primary efficacy data that's coming out of spearhead one.
Okay.
Thank you.
Thanks, Laura.
Thank you once again, please press star one if you have a question. Our next question is from Daniel been Hail from Jones Research. Please go ahead.
Hi, This is Daniel for his service.
Thank you for taking my question.
I have a quick one on the GMP manufacturing space.
Do you have any color.
And completion plans.
Okay.
John would you like to comment on that.
Yeah happy to so thanks for the question.
To have that facility structurally completed.
Later on this year and turned over to operations for us to begin to start to qualify the process and get in there early next year.
That space plus our existing space will have enough capacity in terms of equipment and facility to continue our clinical trials as well as DSM is so large.
Yeah.
Great. Thank you. So this will be also added into the BLA submission.
The new space will not actually our existing space, which we've been using for the last five years for our clinical trial, that's going to be the space that will be part of the submission and will be our commercial supply the new space ultimately won't be for clinical supply only.
Got it thank you.
Thank you.
Thank you.
No further questions registered at this time, so I'll turn the call over to Mr. Rodriguez.
Thank you.
Elliot Norry: Okay.
And thanks, everyone for your time today I Hope you heard that we are both excited about and focused on the priorities.
Elliot Norry: I see.
That we outlined at the beginning of this goal about progress thereof.
Dennis Williams: And one more question on the BLA submission.
Dennis Williams: When do you expect to complete the evaluation of the potency assay?
Dennis Williams: Can you have a pre-BLA meeting before this happens?
Dennis Williams: Dennis?
I look forward to updating you at conferences and our live event on September nine the first day of asthma in the meantime, please feel free to reach out with any questions. Thank you again for your time.
Dennis Williams: Yeah.
Operator: We expect to be able to develop the SURPASS family of trials within the envelope that, our runway guidance indicates, and I think that includes SURPASS 2 and SURPASS 3, and I'll point you back to the update that we plan on giving on SURPASS and the data on, the first day of ESMO, September 9th.
Dennis Williams: Sure.
Operator: Thank you.
Dennis Williams: Essentially, the T cell potency assay that I mentioned is actually in progress of being, validated imminently, like within days.
Operator: Our next question is from Jonathan Chang from SVB Lyrinc.
Dennis Williams: So the pre-BLA meeting, as I mentioned, is scheduled.
Operator: Please go ahead.
Dennis Williams: We have been using – I probably should circle back – we have been using this potency, assay throughout development for this product, and certainly that assay was used all through the SPIRIT1 clinical trial.
Operator: Hi, guys.
Dennis Williams: We have optimized the assay to be more appropriate for a commercial lot release assay, so this, was sort of supplementary validation work that was completed in advance of T cell PPQ, which I mentioned is starting imminently.
Operator: Please state your company and proceed with your question.
Operator: Thanks for taking my questions.
Dennis Williams: Great.
Operator: Hey, this is Paul.
Operator: First question, can you discuss how we should be thinking about duration of clinical benefit, with the NextGen MAI-G4 program and the SURPASS studies?
Dennis Williams: Very helpful.
Operator: I'm from Michael Guggenheim.
Operator: Elliot, do you have any comments on that at this point?
Dennis Williams: Thank you, guys, and congratulations on the progress.
Operator: Thanks for taking my question.
Operator: Hi, Jonathan.
Operator: And thanks everyone for your time today.
Dennis Williams: Thank you.
Operator: So, on SURPASS, we saw that you've opened the NEVO combination arm.
Operator: What I would say is the update to the SURPASS program at ESMO will include data on durability, of response.
Operator: I hope you heard that we are both, excited about and focused on the priorities that we outlined at the beginning of this call and our progress thereon.
Operator: Next question is from Peter Lawson from Barclays.
Operator: Has that begun recruiting?
Operator: I don't think we're providing any guidance as it relates to that at this time, so I would, look forward to the data that's going to be presented at ESMO, which will include response rate and durability of response.
Operator: I look forward to updating you at conferences and our live event on September 9th, the first day of ESMO.
Operator: Please go ahead.
Thank you. Your conference has now ended please disconnect your lines at this time and we thank you for your participation.
Operator: And when will we potentially see clinical data?
Operator: Got it.
Operator: In the meantime, please feel free to reach out with any questions.
Operator: Hi.
Operator: And is there any waiting or improvement to that arm for patients who can be PD-1 responsive or plans to report patients by PJL-1 expression level?
Operator: Are you able to maybe provide some thoughts on what the reasons for confidence are that, you'll be able to achieve durable clinical benefit?
Operator: Thank you again for your time.
Operator: Good morning.
Operator: Elliot?
Operator: Yep.
Operator: Thank you.
Operator: This is Alex on for Peter.
Operator: Yes.
Operator: So I'll take a first stab at that, Pastor Elliot.
Operator: Your conference has now ended.
Operator: Please disconnect your lines at this time and we thank you for your participation.
Operator: Thank you for taking our question.
Operator: So, thanks.
Operator: I think the reasons for durable clinical benefit would start with the data from the SPAREHEAD1, trial, which clearly shows that in a solid tumor, cell therapy can deliver durable responses that are of significant benefit to patients, and that will form, obviously, the basis of the BLA file later on this year.
Operator: Just on Surpass 3, any insights you could give us around trial design and execution, you know, how many patients you're planning to enroll, is it going to be platinum in eligible patients, and if you're planning any combination studies here as well?
Operator: I can confirm that that arm is open and enrolling patients being, rolled out to the SURPASS study sites as quickly as we can do.
Operator: I think the purpose of the second generation was to extend the opportunity in cell therapy, to broader tumor types.
Operator: Thank you.
Operator: We are measuring PD-1 expression at baseline, so we will be able to provide insights as it relates to baseline PD-1 expression in relation to response.
Operator: That's what we're dealing with with the SURPASS trial and in the SURPASS family of trials.
Operator: So I'll just say that we haven't made public any details of the trial design, et cetera, but if you were looking for an update on the Surpass family of trials, then I would suggest that our webcast on the 9th of September would be a good place to start.
Operator: Thank you.
Operator: And I think, apart from that, I'm going to have to—and all the other technical discussions, that we've had over the years, I would punt you to the data, to the update in September.
Operator: Okay, great.
Operator: Our next question is for Mara Goldstein from Mizuho Securities.
Operator: Just maybe one thing to point to, though.
Operator: And just another question quickly.
Operator: Please go ahead.
Operator: I think the fact that we are seeing robust responses in very late-stage patients in the, SURPASS1 trial is also reason for confidence of the clinical benefit that can be achieved in the right patient populations with these therapies.
Operator: Given the cost containment measures you mentioned, you expect you'll be able to drive both, Surpass 2 and 3 programs forward and parallel, or do you expect you might need to maybe prioritize one over the other?
Operator: Oh, thanks very much.
Operator: And with that, I will defer to September 9th.
Operator: Just a couple quick ones.
Operator: Got it.
Operator: Just with respect to the cost containment efforts,
Operator: Maybe just a couple higher level questions for you guys.
Operator: I think I saw the last figure that I saw in your deck is that you have about 500 FTEs across the various manufacturing facilities.
Operator: And that is, how does PRAME, compare to MAGE-A4 as a TCR target?
Operator: And is that still the case even with these cost containment issues?
Operator: And also, how do you guys think about the interplay between TCR bi-specifics and TCR self-therapies?
Operator: And then just on spearhead one, I know you've spoken to the primary clinical support for the BLA filing as cohort one, but can you speak to what other data you plan to submit to support the filing?
Operator: Thank you.
Operator: Hi, Mara.
Operator: So I'm going to ask Joeper or CSO to talk about that.
Operator: It's Gavin speaking.
Operator: I think when it comes to PRAME and MAGE-A4, obviously we have our own thoughts about those targets and there's obviously significant overlap in certain tumors.
Operator: Hi, Gavin.
Operator: The PRAME program that we have is obviously partnered with GSK, so that's something that, we can't do independently from them, whereas obviously MAGE-A4 is within our control.
Operator: So FTEs, we're running a little over 500 now as we've begun to ramp up on the commercialization, and also to complete the BLA submission.
Operator: So I think there are different targets and there are different TCRs, and I think that's really, we will have to see how those play out in the clinic.
Operator: But that's the sort of broad number we're targeting.
Operator: We optimize our TCRs very specifically.
Operator: And then on the BLA, Dennis?
Operator: We do that optimization for every single program, and I can't comment on other people's, TCRs in relation to our own.
Operator: Yeah, sure.
Operator: But they're both well-presented targets in solid tumors, and I'm sure there will be clinical successes with both.
Operator: So there's a lot of things that we would use to support the clinical dossier. They would include things like integrated or pooled efficacy and safety analyses, some of which, you know, we showed back at ASCO, but there are more than that.
Operator: And then when it comes to bi-specifics, versus cell therapies, I think pros and cons to both of those.
Operator: We have a number of exposure response analyses, non-compartmental analyses taken into, you know, FAMISL exposure and its relationship to efficacy and things of this nature that help supplement the primary efficacy data that's coming out of spearhead one.
Operator: It depends on the target density and how well that works with the T cells.
Operator: Okay.
Operator: So having the TCR actually inside the T cell versus having a bridge in between, I think, again, we will see how that plays out with the number of peptides on the surface of the cells.
Operator: Thank you.
Operator: And also I think the tumor microenvironment plays a big role there as well.
Operator: Thanks, Mara.
Operator: So, again, I don't think there's anything I can necessarily say here because we only deal with cell therapies rather than bi-specifics ourselves.
Operator: Thank you once again.
Operator: Got it.
Operator: Please press star one if you have a question.
Operator: Thanks for taking my questions.
Operator: Our next question is from Dania Ben-Hale from Jones Research.
Operator: Thank you.
Operator: Please go ahead.
Operator: Our next question is from Michael
Operator: Hi.
Operator: Smith.
Operator: This is Dania from Show-Me-Troy.
Operator: Thank you for taking my question.
Operator: I have a quick one on the GMP manufacturing space at the Navy Yard.
Operator: Do you have any color on the completion and plans?
Operator: John, would you like to comment on that?
Operator: Yeah, happy to.
Operator: So thanks for the question.
Operator: Yeah, we're looking to have that facility structurally completed later on this year, and turned over to operations for us to begin to start to qualify the process and get in there early next year.
Operator: And with that space plus our existing space, we'll have enough capacity in terms of equipment and facility to continue our clinical trials as well as the FAMISL launch.
Operator: Great.
Operator: Thank you.
Operator: So this will be also added into the BLA submission?
Operator: The new space will not, actually.
Operator: Our existing space that we've been using for the last five years for our clinical trial, that's going to be the space that will be part of the submission and will be our commercial supply.
Operator: The new space ultimately will be for clinical supply only.
Operator: Got it.
Operator: Thank you.
Operator: There are no further questions registered at this time, so I'll return the call over to Mr. Rockless.
Operator: Thank you.