Q3 2021 Iovance Biotherapeutics Inc Earnings Call
Operator: Biotherapeutics third quarter and year-to-date 2021 financial results. My name is Andrew, and I'll be your operator for today's call. At this time, all participants are in a listen-only mode.
Welcome to the idle dance Biotherapeutics third quarter and year to date 2021 financial results.
My name is Andrew and I'll be your operator for today's call.
At this time all participants are in a listen only mode.
Operator: Later, we'll conduct a question and answer session. During the question and answer session, if you have a question, please press star, then 1 on your touchtone telephone. Please note that today's conference is being recorded. I will now turn the call over to Sara Pellegrino, Vice President, Investor, and Public Relations at Iovance. Sara, you may begin.
We will conduct a question and answer session.
During the question and answer session. If you have a question. Please press Star then one on your Touchtone telephone.
Note that today's conference is being recorded.
I will now turn the call over to Sara Pellegrino, Vice President Investor and public relations at idled in Sir you may begin.
Sara Pellegrino: Thank you, Operator. Good afternoon, and thank you for joining us. Speaking on today's call, we have Fred Vogt, our Interim President and Chief Executive Officer, Igor Bilinsky, our Chief Operating Officer, Jim Ziegler, our Senior Vice President, Commercials, Dr. Frederick Finckenstein, our Chief Medical Officer, and Jean-Marc Bellemin, our Chief Financial Officer. Dr. Madan Jagatia, our Senior Vice President of Medical Affairs, and Laurel Todd, Vice President of Policy, are also on the call to participate in the Q&A session.
Thank you operator, good afternoon, and thank you for joining us.
On todays call, yes, I'd vote, our interim President and Chief Executive Officer, Igor Balinsky, Our Chief operating Officer, Jim Ziegler, Our senior Vice President commercial Dr. Frederic.
Our Chief Medical Officer, and John Mark Allen, Our Chief Financial Officer Dr.
Dr. <unk> <unk>, our senior Vice President Medical Affairs, and Brocard Vice President of policy are also on the call to participate in the Q&A session.
Sara Pellegrino: This afternoon, we issued a press release that can be found on our website at iovance.com, which includes the financial results for the three and nine months ended September 30th, 2021, as well as corporate updates. Before we start, I would like to remind everyone that statements made during this conference call will include forward-looking statements regarding Iovance's goals, business focus, business plans, pre-commercial activities, clinical trials, and regulatory plans and results, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interactions, collaborations, cash position and expense guidance, and future updates.
The afternoon, we issued a press release that can be found on our website.
Dotcom, which includes the financial results for the three and nine months ended.
September 32021, as well as corporate update.
Before we start I would like to remind everyone that statements made during this conference call will include forward looking statements regarding <unk> goals business focus business plan pre commercial activities clinical trials and regulatory plans and results potential future applications of our technology manufacturing capability.
Regulatory feedback and guidance.
Payer interaction collaboration cash position and guidance and future update.
Sara Pellegrino: 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.
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 Brett.
Frederick G. Vogt: Thank you, sir, and good afternoon, everyone. I'm pleased to highlight our year-to-date progress at Iovance during today's conference. We have continued to advance our tumor infiltrating lymphocyte, or TIL, platform into new indications and earlier treatment settings throughout this year. For our lead TIL product candidate, Lifelucel, and Metastatic Melanoma, our top priority remains our ongoing work to address FDA feedback regarding the potency assays for Lifelucel to support our planned VLA submission. We have continued our ongoing work developing and validating our potency assays and have engaged in discussions with FDA during the second half of 2021. The anticipated BLA submission for Life of Lusal continues to be planned for the first half of 2022. We remain confident in our current direction.
Thank you Sarah and good afternoon, everyone.
I am pleased to highlight our year to date progress that I have answering today's conference call.
We have continued to advance our tumor infiltrating lymphocyte or til platform into new indications and earlier treatment settings throughout this year.
For our lead product candidate life of Luzon metastatic melanoma, our top priority remains our ongoing work to address FDA feedback regarding the potency assays for life, a loophole to support our planned BLA submission.
We have continued ongoing work developing and validating our potency assays and are engaged in discussions with FDA during the second half of 2021.
The anticipated BLA submission for life of Leucyl continues to be plans for the first half of 2022.
We remain confident in our current guidance and timelines resolution of the potency assays for life of Leucyl.
Also an important next regulatory step for our cervical non small cell lung clinical programs.
Turning to our clinical pipeline, we now have clinical data showing the promise of til therapy for different solid tumor types from first line to late stage treatment settings, furthering our confidence until the broad platform that may shift the treatment paradigm for patients with cancer.
Frederick G. Vogt: Resolution of the potency assays for Lifelucel is also an important next regulatory step for our cervical and non-small cell lung clinical programs. Turning to our clinical pipeline, we now have clinical data showing the promise of TIL therapy in four different solid tumor types from first-line to late-stage treatment settings, furthering our confidence in TIL as a broad platform that may shift the treatment paradigm for patients with cancer. We continue to be excited about three key initiatives that have the potential to meaningfully impact patients while creating shareholder value.
We continue to be excited about three key initiatives that have the potential to meaningfully impact patients', while creating shareholder value.
First life loose stool and post anti PD, one melanoma continues to show increasing long term durability following onetime treatment as demonstrated in our <unk> 2021 presentation, where we showed median duration of response was not reached at 33 months median study follow up.
Second we continue to build on the potential for the combination of til plus a map, which supports our strategy to broaden access to til therapy for more patients and earlier treatment settings.
We're excited about presenting combination data in several advanced cancers at the upcoming <unk> annual meeting.
As noted in this afternoon's press release, the FDA granted fast track designation for life Leucyl in combination with <unk> for the treatment of metastatic melanoma.
Frederick G. Vogt: First, lifelucidal and post-anti-PD-1 melanoma continues to show increasing long-term durability following one-time treatment, as demonstrated in our ASCO 2021 presentation, where we showed that median duration of response was not reached at 33 months of median study follow-up.
Based on the unmet medical need of potential advantages for this combination over available care.
This fast track designation allows for potential et cetera accelerated approval and priority review as well as more frequent interactions with FDA.
Finally, our initial clinical data in metastatic non small cell lung cancer demonstrated a 21, 4% overall response rate in heavily pretreated patients all of whom have progressed on prior immune checkpoint inhibitor therapy.
This population represents a significant unmet need in non small cell lung cancer.
Frederick G. Vogt: Second, we continue to build on the potential for the combination of TIL with pembrolizumab, which supports our strategy to broaden access to TIL therapy for more patients in earlier treatment settings. We're excited about presenting combination data and several advanced cancers at the upcoming SIPSI annual meeting. As noted in this afternoon's press release, the FDA granted fast-track designation for lifalucil in combination with Pemrolizumab for the treatment of metastatic melanoma based on the unmet medical need and potential advantages for this combination over available care.
We provided a topline corporate announcement of the initial data earlier.
Earlier in the second quarter and look forward to presenting these data to a physician audience for the first time during the upcoming <unk> meeting.
On the research side, we are bringing the next generation of til products and supported therapies into the clinic.
We're advancing a toll product is genetically modified to inactivate PD, one, which we have designated <unk> 4001, as well as our novel IL two analog IV 3001.
Both IOP for sales of one and 3001 are progressing through IND, enabling studies and are moving towards the clinic.
In summary, we continue to execute all development manufacturing and pre commercial activities and furthering our commitment to address the critical needs of patients with cancer in multiple solid tumor cancers and treatment settings.
I am confident in the quality of our senior leadership as well as our full internal and internal organization to deliver towards this mission.
Frederick G. Vogt: This FASTRAC designation allows for potential accelerated approval and priority review as well as more frequent interactions with FDA. Finally, our initial clinical data in metastatic non-small cell lung cancer demonstrated a 21.4% overall response rate in heavily pre-treated patients, all of whom have progressed prior Immune Checkpoint Inhibitor therapy. This population represents a significant unmet need in non-fossil soil.
We have more than 300 employees, who on average have more than three and a half years of cell therapy experience.
Because of our executive leadership team will now provide updates for the respective departments, beginning with our Chief operating officer Igor Bolinsky.
Thank you Brian.
I'm pleased to speak today about our new manufacturing facility. The events. So there would be some care or ice PTC at the Navy yard Littlefield.
<unk> is the 136000 square foot.
We are LEED gold sort of quite its cell therapy manufacturing facility.
In the third quarter at ICD, we initiated manufacturing of investigational therapies for patients enrolled in clinical trials, followed by an official opening ceremony here at the end of September.
To date more than 500 patients have received <unk> with the continuing manufacturing success rate above 90%.
<unk> has transformed til manufacturing from a lengthy single center academic process to a shorter scalable centralized GMP process that yields the cryopreserved product or shipment back the clinical sites, where the patients are treated.
Frederick G. Vogt: We provided a top-line corporate announcement of the initial data earlier in the second quarter and look forward to presenting these data to a physician audience for the first time during the upcoming CIDSI meeting. On the research side, we are bringing the next generation of co-products and supporting therapies into the clinic. We are advancing a pill product that is genetically modified to inactivate PD-1, which we have designated IV4001, as well as our novel IL-2 analog, IOV-3000.
Our current Gen. Two process is 22 days.
We're also continuing to advance our leadership position through our ongoing clinical studies to investigate the 16, the third generation or Gen three process Jim.
Further improve part of them still manufacturing efficiencies and deliver items still to patients even sooner. We also believe the 16 days with two manufacturing is the fastest in the industry at this time.
In addition to commencing clinical manufacturing discipline, investigational or bounce til therapies to patients with cancer enrolled in our clinical trials.
We are advancing commercial manufacturing readiness activities for items two CDC <unk>.
Commercial supply remains on track for 2022 pending regulatory approval with ultimate capacity to meet the demands of thousands of patients in multiple indications.
Frederick G. Vogt: Both IOV4001 and IOV3001 are progressing through IMD-enabling studies and are moving towards the clinic. In summary, we continue to execute all development, manufacturing, and pre-commercial activities in furthering our commitment to address the critical needs of patients.
Support by events to manufacturing capabilities and the pipeline, we have been sharply focused on building, our robust and growing intellectual property or IP portfolio.
Today, we have more than 30 granted and allowed U S and international patents and more than 700000, some sensitive applications all globally across major pharmaceutical markets and other key geographies.
In the past quarter expansion still doesn't portfolio includes two new patents covering compositions repairs from tumor digest and methods of creating HPE treating HPV positive cancers, including cervical and head and neck cancers.
Frederick G. Vogt: I'm confident in the quality of our senior leadership as well as our full internal organization to deliver on this mission. Today, we have more than 300 employees who, on average, have more than three and a half years of cell therapy experience. Members of our executive leadership team will now provide updates for their respective departments, beginning with our Chief Operating Officer, Igor Bilinsky. Thank you, Fred.
We believe that our internal manufacturing and that position has firmly established our leadership in developing and delivering til therapies for unmet need patient populations with counsel.
I would now like to hand, the call to Jim Ziegler, Our senior Vice President commercial to highlight our commercial launch preparations Jim.
Thanks Igor.
This year, including earlier this quarter at our ribbon cutting event, we have been fortunate to meet several key opinion leaders investigators patients and family members, who all understand the challenges of metastatic melanoma the.
Igor P. Bilinsky: I'm pleased to speak today about a new manufacturing facility, the Iovance Cell Therapy Center, or ICTC, at Navy Yard Little. The ICDC is a 136,000 square foot, state-of-the-art, LEED Gold Certified cell therapy manufacturing facility. In the third quarter at ICDC, we initiated manufacturing of investigational tool therapies for patients enrolled in high-advance clinical trials, followed by an official opening ceremony at the end of September. To date, more than 500 patients have received Iovance, still with a continuing manufacturing success rate above 90%.
The opportunities to hear their stories reinforce our commitment and our sense of urgency to bring <unk> to market.
And I events, we have a mission to be the global leader in innovative <unk>.
<unk> and delivering fuel cell therapy for patients with cancer.
This is an obligation we all take personally.
Our commercial team remains focused on customer and patient centricity to ensure a positive experience with LIFO leucyl in three areas of operational excellence.
We continue to enhance our partnership with a leading U S cancer centers to build their Io events till service line capabilities.
We are pleased with the partnership and engagement with these centers around a shared goal to ensure timely and appropriate access to LIFO leucyl upon approval.
Igor P. Bilinsky: Iovance has transformed film manufacturing from a lengthy, single-center academic process to assure a scalable centralized GMP process that yields a cryopreserved product for shipment back to clinical sites for the patients that treat them. Our current Gen 2 process is 22 days.
Our customer centric Onboarding program includes a training curriculum that ensures cross disciplinary teams at each authorized treatment center can administer the LIFO leasehold treatment regimen upon FDA approval.
The planned timing and execution of key Onboarding and training is also aligned to our BLA submission to ensure just in time training and readiness.
Igor P. Bilinsky: We're also continuing to advance our TILL leadership position through our ongoing clinical studies to investigate a 16-day third-generation or Gen 3 process. Gen 3 may further improve Iovance till manufacturing efficiencies and deliver Iovance till to patients even sooner. We also believe that 16 days for till manufacturing is the fastest in the industry at this time.
Second our market access team continues to engage commercial Medicare and Medicaid payers to ensure patients have appropriate and timely access to life of Luzon.
We believe payers appreciate the unmet need and the clinical value of Michael do so.
And third the development of biogas cares our own self ordering and patient support platform is on track for launch.
Igor P. Bilinsky: In addition to commencing clinical manufacturing to supply investigational Iovance TIL therapies to patients with cancer enrolled in our clinical trials, we are advancing commercial manufacturing readiness activities for Iovance TIL at ICDC. Commercial supply remains on track for 2022, pending regulatory approval, with ultimate capacity to meet the demand for up to thousands of patients in multiple indications. To support our Iovance 2 manufacturing capabilities and pipeline, we have been sharply focused on building our robust and growing intellectual property, or IP, portfolio. Today, we have more than 30 granted and allowed U.S. and international patents and more than 700 patents and patent applications filed globally across major pharmaceutical markets and other key geographies.
<unk> is designed to be customer centric and planning and coordinating patient care throughout the life of looser a journey.
We have incorporated customer feedback and the design of biogas cares throughout the process.
The platform includes our proprietary chain of identity and chain of custody system.
Our fully integrated patient management approach.
Our integrated approach to quality.
I against cares.
Is patient centric with dedicated our advanced case managers to handle the needs of HCP and patient.
The case managers will also provide reimbursement support for sites and patients at every step of the journey.
Demonstrating operational excellence across these three areas is expected to ensure patients have timely access to life a looser upon approval.
With a gated approach to commercial readiness the commercial organization is well positioned to scale our efforts based upon internal milestones and timelines.
I will now pass the call to Fredrik to highlight our upcoming clinical presentation.
Thank you Jim.
I am pleased to highlight upcoming clinical data update that as well as the status of our ongoing clinical studies.
James Ziegler: In the past quarter, expansions to our patent portfolio included two new patents covering till compositions, repairs from tumor digests, and methods of treating HPV-positive cancers, including cervical and head and neck cancers. We believe that our internal manufacturing and IP position have firmly established our leadership in developing and delivering tilt therapies for unmet need patient populations with cancer. I would now like to hand the call to Jim Ziegler, our Senior Vice President, Commercial, to highlight our commercial launch preparations. Jim?
Adjusted the strategy focuses on cancer populations with high unmet need.
Central opportunity for children make a meaningful impact.
Since we have upcoming presentations as well as the conference call and webcast.
<unk> touch upon the highlights.
As Fred mentioned, we are excited about the combination of til, but tempered. This amount is an approachable earlier line treatment setting.
Primary resistance to immune checkpoint inhibitors as frequently observed in multiple tumor types. There is a need to increase overall response rate and deepen responses with more complete responses and anti PD one naive patients.
Previous results presented in head and neck cancer melanoma patients demonstrated overall response rate.
Significantly higher than <unk> alone in patients who are naive to immune checkpoint inhibitors.
Moving to our non small cell lung cancer program <unk> will be the first medical meeting for us to share clinical data.
James Ziegler: Thanks, Igor. Throughout this year, including earlier this quarter at our ribbon-cutting event, we have been fortunate to meet several key opinion leaders, investigators, patients, and family members who all understand the challenges of metastatic melanoma. The opportunities to hear their stories reinforce our commitment and our sense of urgency to bring Life of Lusso to market. At Iovance, we have a mission to be the global leader in innovating, developing, and delivering kill cell therapy for patients with cancer. This is an obligation we all take personally.
Therapy, and then $1 45 in patients with metastatic non small cell lung cancer, who enrolled in cohort three BLT ongoing basket study ILD come to <unk>.
As a reminder, what we be enrolled patients that had progressed on prior immune checkpoint inhibitor therapy. This was a heavily pretreated population for which there is a significant unmet need to increase response rates and prolonged survival.
As previously reported in our topline public announcement, we were very pleased to see an overall response rate of 21, 4% and we look forward to providing additional detail.
Turning to our ongoing clinical study we have four active clinical studies with <unk> so that follows.
James Ziegler: Our commercial team remains focused on customer and patient centricity to ensure a positive experience with lipoleucel in three areas of operational excellence. First, we continue to enhance our partnership with leading U.S. cancer centers to build their Iovance pill service line capability. We are pleased with the partnership and engagement with these centers around a shared goal to ensure timely and appropriate access to Lifelucel upon approval. Our customer-centric onboarding program includes a training curriculum that ensures cross-disciplinary teams at each authorized treatment center can administer the lipoleucel treatment regimen upon FDA approval. The planned timing and execution of key onboarding and training is also aligned to our BLA submission to ensure just-in-time training and readiness.
And our <unk> 202 study in second line lung cancer, which has more than 20 active sites in the U S and Canada.
In our ILD come to a basket study of Ireland, Joel until plus immune checkpoint inhibitor combination we have completed enrollment in the relapsed refractory non small cell lung cancer and head and neck cohort.
Recruitment continues in melanoma and with til combination in non small cell lung cancer.
And our key one five what clinical study in cervical cancer, we continued to recruit a cohort of patients not previously treated with systemic therapy or anti PD one.
I'll then till embolism.
Symbolism.
We are also actively enrolling and all in all you'll be E. L. L zero one.
In T L. L L allocation, which is all off first hematologic indications.
I will now hand, the call over to Mark to discuss our third quarter 2021 financial results.
Thank you.
My comments will reflect the high level financial results from the third quarter and year to date 2021.
Additional details can be found in this afternoon's press release as well as in our SEC filings.
I will begin with our cash position.
James Ziegler: Second, our market access team continues to engage commercial, Medicare, and Medicaid payers to ensure patients have appropriate and timely access to Lifeloose. We believe payers appreciate the unmet need and the clinical value of Lifeloose. And third, the development of Iovance Cares, our own cell ordering and patient support platform, is on track for launch. Iovance Cares is designed to be customer-centric in planning and coordinating patient care throughout the life elusive journey
As of September 30, 2021.
$668 million Golar, <unk>, gosh cash equivalents investments and restricted cash compared to $635 million on December 31st 2020.
Our strong cash position is expected to be sufficient well into 2023 to advance our operating plan, including pipeline development commercial manufacturing readiness and launch preparation.
No immediate need to raise capital.
Moving on to the income statement, our net loss for the third quarter ended September <unk>.
<unk> was $86 1 million <unk> 55 per share compared to a net loss.
$8 6 million or <unk>.
<unk> per share for the third quarter ended September 32020.
James Ziegler: We have incorporated customer feedback in the design of Iovance Cares throughout the process. The platform includes our proprietary chain of identity and chain of custody system, our fully integrated patient management approach, and our integrated approach to quality. Iovance Cares is patient-centric with dedicated Iovance case managers to handle the needs of HCPs and patients. The case managers will also provide reimbursement support for sites and patients at every step of the journey.
Net loss for the nine months under the September 13, 2021 was $242 9 million or $1.
True compared to a net loss of $191 2 million.
$1 41 per share for the same period ended September 32012.
Research and development expenses were $65 4 million.
Well the third quarters ended September 32021.
An increase of 22 going through.
$2 3 million.
Compared to $42 1 million for the third quarter ended September 32020.
Research and development expenses were <unk> hundred $82 $4 million for the nine months ended September 32021, an increase of $34 1 million.
James Ziegler: Demonstrating operational excellence across these three areas is expected to ensure patients have timely access to Lifelucid upon approval. With a gated approach to commercial readiness, the commercial organization is well positioned to scale our efforts based upon internal milestones and timelines. I will now pass the call to Frederick to highlight our upcoming clinical presentation. Thank you, Jim.
Compared to $149 2 million.
For the same period ended September <unk> 2020.
The increase in research and development expenses in the third quarter of 2012 Q1 over the prior period.
It's primarily attributable to an increase in cost associated with growth of the internal research and development team and increases in clinical trial cost and.
She's the chief Hudson City related cost.
During cruising released a new research and development expenses in the first nine months of 2021, although the priors or failure.
Friedrich Graf Finckenstein: I am pleased to highlight upcoming clinical data updates, as well as the status of our four ongoing clinical studies. Our drug development strategy focuses on cancer populations with high unmet needs and substantial opportunity for children to make a meaningful impact. Since we have upcoming presentations as well as a conference call and webcast during SITC, I will briefly touch upon the highlights.
Was primarily attributable to growth of the internal research and development team and then increasing as you can see for some really good cost.
Following completion of their eyes, you can see we have concluded our initial 5 million investments in Costco.
Yeah.
General and administrative expenses were up $20 9 million.
Third quarter ended September 32021, an increase of $5 million compared to $15 9 million.
For the third quarter ended September 32012.
General and administrative expenses were 59 million.
Friedrich Graf Finckenstein: As Fred mentioned, we are excited about the combination of TIL with Tambrylizumab as an approach for early-aligned treatment settings. Primary resistance to immune checkpoint inhibitors is frequently observed in multiple tumor types. There is a need to increase overall response rates and deepen responses with more complete responses in anti-PD-1 nave patients. Previous results presented in head and neck cancer and melanoma patients demonstrated overall response rates that are significantly higher than pembrolizumab alone in patients who are naive to immune checkpoint inhibitors.
For the nine months ended September 32021.
Crews are $15 7 million.
Compare that to $44 1 million for the same period ended September 32012.
The increase in general and administrative expenses in the third quarter and first nine months of 2021 compared to the prior year periods were primarily attributable to growth of the internal general an enemy.
And now your stock based compensation expenses.
As of September 32021.
There are approximately $156 7 million common shares outstanding.
We continue to focus on investments in full.
Rob.
I was outlining crews to ensure the grow some strengths of our value creation.
Include advancement and the expansion of our clinical pipeline launch readiness, a strong cash position and manufacturing.
Friedrich Graf Finckenstein: Moving to our non-small cell lung cancer program, SIDSI will be the first medical meeting for us to share clinical data for our chill therapy LN145 in patients with metastatic non-small cell lung cancer who enrolled in cohort 3B of the ongoing basket study IOVCOM202. As a reminder, QOR3B enrolled 28 patients that had progressed from prior immune checkpoint and liberal therapy. This was a heavily pre-treated population for which there is a significant unmet need to increase response rates for long survival. As previously reported in our Topline Corporate announcement, we were very pleased to see an overall response rate of 21.4%, and we look forward to providing additional details at CITI.
<unk>, which will provide new cost efficiencies as we are go to shift work from keeping going through contract manufacturers.
Yeah.
I remain confident that by managing our investments across the disparity will continue to stay focused and aligned or spending resort corporates violations.
I will now the call back to the operator to kick off the Q&A session.
Thank you.
As a reminder to ask a question you will need to press star one on your telephone.
Draw your question press the pound key.
We ask that you. Please limit yourself to one question and then you may re enter the queue.
If time permits we will take any additional questions.
Our first question comes from the line of married Goldstein with Mizuho.
Oh, thanks, very much for taking the question.
So I just wanted to go back for a second to that question is the discussion with FDA and I respect that there's very little that you can say about it but.
Friedrich Graf Finckenstein: Turning to our ongoing clinical studies, we have four active clinical studies with Iovance to let follow. In our IOV-LUM202 study on second-line lung cancer, which has more than 20 active sites in the U.S. and Canada. In our IOV-COM-202-BASCIT study of Iovance-TIL and TIL-PLUS immune-checkpoint inhibitor combination, we have completed enrollment in the V-LABS refrac Recruitment continues in melanoma and with chill combinations in non-small cell lung cancer.
You know the press release makes reference to.
It's still being able to come up with a solution that will satisfy the agency and so I'm wondering if you can maybe share with us.
You know where you are in the process in terms of the discussion level with them. You know the original plan had been that you had some assays already on hand and that you also are pursuing it development track for new assays and present those to the agency. So maybe you know because you were just.
About Anniversarying. This maybe you can kind of walk us through exactly where things are at.
Sure.
That was the plan.
As we as we discussed back in June.
Friedrich Graf Finckenstein: In our C.1.4.5.0.4 clinical study in advanced cervical cancer, we continue to recruit a cohort of patients not previously treated with systemic therapy or anti-TD1 to receive Iovance TILT plus embolism masks. We are also actively enrolling in our IOV-CLL01 study in CLL-SLL patients, which is our first hematologic indication. I will now hand the call over to Jean-Marc to discuss our third quarter 2021 financial report.
That's still the plan, we're just right now we're in the world.
When we're having this thing.
The FDA and those regulatory discussions.
Yes.
So sorry, Ana contractual I mean is it fair to characterize that you are still in a back and forth with the agency.
Yes, you can call I mean, we would describe it as engagement, but yes, we're in them.
And having kind of having that kind of level with them.
And again the anticipated BLA filing timeline is still firsthand at this point.
Okay, and I know I appreciate the disc.
The discussion around.
The activity is as companies undertaking in the dance being able to submit and then I'm thinking you know from a commercial perspective, but.
Relative to the capital that the company raised ahead of us.
Being able to ahead of launching and where you are now I'm I'm just curious about how much capital.
Jean-Marc Bellemin: My comments will reflect the high-level financial results from the third quarter and year-to-date 2021. Additional details can be found in this afternoon's press release, as well as in our SEC file. I will begin with your cash position.
Being deployed.
While you are waiting that you would've otherwise not spend.
Well, we're continuing to run our research and development program as we would normally have spending so we have all the clinical assets still progressing.
We're just running this in parallel so I don't I wouldn't characterize it that way I would basically say we are continuing the development of til platform as we intended and at the same time, we're working with FCA on moving forward on the potency assay situation, which is something that we think are the gating item across the play.
Jean-Marc Bellemin: As of September 30, 2021, Iovance held $660.8 million in cash, cash equivalents, investments, and restricted cash, compared to $635 million on December 31, 2020. Our strong cash position is expected to be sufficient well into 2023 to advance our operating plan, including pipeline development, commercial manufacturing readiness, and launch preparation, with no immediate need to raise elusive capital. Moving on to the income statement, our net loss for the third quarter ended September 30, 2021 was $86.1 million, or $0.55 per share, compared to a net loss of $58.6 million, or $0.40 per share, for the third quarter ended September 30, 2021.
Platform right now.
Okay, I really appreciate I'll hop off and let others ask questions.
No problem. Thank you Maher.
Thank you and our next question comes from the line of Michael <unk> with Jefferies.
Hi.
Thanks, and I appreciate the question Mike.
My question is if you feel that you can reiterate the filing guidance today. What are you specifically waiting for is it an official sign off on the assay is it meeting minutes.
Do you have a good sense of what actually is going to be measured can you just give us a sense of the fact that you feel very good about that and perhaps you're just waiting for meeting minutes. I guess that's question. One and then question. Two is would you press release. This announcement tell us what what happened what would need to then happen after that actually.
Thank you.
Sure.
Thanks, Mike.
Well, let me take them in reverse order on the on the press release.
When we.
Well material information available to US for example responses from the FDA that are clear that we could put a press release out on the basis of I think we would try to do that we would very much like the update update the market as soon as we can about the situation with FDA and our potency assays of course.
Turning to turning to your first question.
Jean-Marc Bellemin: The net loss for the nine months ending September 30, 2021 was $242.9 million, or $1.60 per share, compared to a net loss of $191.2 million, or $1.41 per share, for the same period ended September 30, 2021. Research and development expenses were $65.4 million for the third quarter and September 30, 2021, an increase of $22.3 million compared to $43.1 million for the third quarter and September 30, 2020. Research and development expenses were $183.4 million for the nine months ended September 30, 2021, an increase of $34.1 million compared to $149.3 million for the same period ended September 30, 2020.
It's a very detailed long engagement that we're you know it's a six month process here and it could go beyond that of course into 'twenty. Two we never said, we might we might have containment stuff spill over into early 'twenty two as we sort this out but nevertheless ah.
And just sort of a blow by blow things with the FCA, yes, there are things like minutes, yes, there are responses from the FDA and that sort of thing.
We're not we're not particularly waiting on anything right now that will update when we can based on the disclosures that we have available to us at the time.
Yes.
Thank you.
Thank you.
Our next question comes from the line of Mark Breidenbach with Oppenheimer.
Hey, guys, it's Matt on for Mark Thanks for the question I.
I apologize if this has been asked before but I am just trying to think of worst case scenarios here on the phone and Cathay and Pat have we've ruled out FDA asking you for a randomized trial in order to support our initial approval is that something thats been discussed or is that completely out of the question.
Thanks.
Yeah.
Yes. Thanks.
While we can never say what F D. A truly might want at the end right now it is not asking for that so the way we've been treating this entire interaction with FDA is on the basis that we would be able to use the court for a pivotal study data that we've already generated.
Great. Thanks.
Okay.
Jean-Marc Bellemin: The increase in research and development expenses in the third quarter 2021 over the prior year period was primarily attributable to an increase in cost associated with the growth of the internal research and development team, an increase in clinical trial costs, and ICTC facility-related costs. The increase in research and development expenses in the first nine months of 2021 over the prior year period was primarily attributable to growth of the internal research and development team and an increase in ICTC facility Following completion of the ICTC, we have concluded our initial $85 million investment in constructing the facility.
Thank you.
Jean-Marc Bellemin: General and administrative expenses were $20.9 million for the third quarter and September 30, 2021, an increase of $5 million compared to $15.9 million for the third quarter and September 30, 2020. General and administrative expenses were $59.8 million for the nine months ended September 30, 2021, an increase of $15.7 million compared to $44.1 million for the same period ended September 30, 2020. The increase in general and administrative expenses in the third quarter and first nine months of 2021 compared to the prior year periods was primarily attributable to growth of the internal general and administrative scheme and higher stock-based compensation expenses. As of September 30, 2021, there were approximately 156.7 million common shareholders.
Great. Thanks, and I guess, just one more on the <unk> 202 study.
Would you be able to contrast, both the enrollment rate and the number of patients you have treated so far.
Based on PD lone expression level, so below 1% and <unk>.
Above 1% to 49%.
The two cohorts.
Fredrick do you want to answer that one.
Sure Yeah. Thanks for the question I don't think that at this time, we will be commenting on the number of enrolled patients.
Remember the study is designed to enroll patients who have failed one line of prior chemo immunotherapy combination.
In two different cohorts cohorts, one and cohort two I would expect since the available available care for these patients is similar that the distribution across the two cohorts would be reflective of our of the distribution of the PDL one status in the population.
Jean-Marc Bellemin: We continue to focus on investment in four key areas, as outlined previously, to ensure the growth and strength of our value creation. These include advancement and expansion of the clinical pipeline, launch readiness, a strong cash position, and manufacturing at ICTC, which will provide new cost efficiencies as we are able to shift work currently being done through contract manufacturers to ICTC. I remain confident that by managing our investment across these priorities, we will continue to stay focused and align our spending with our corporate priorities. I will now hand the call back to the operator to kick off the Q&A session.
You can assume it's about one third and two third.
But but again.
I don't think that we're going to comment on the exact enrollment number or distribution at this time.
Thank you appreciate it.
Thank you and our next.
Question comes from the line of Madhu Kumar with Goldman Sachs.
Yeah. Thanks for taking our question so.
We think about kind of the potency assay situation to what extent is.
This kind of a process of negotiation of kind of like sorting out your views on what are kind of relevant potency assays versus kind of the regulators take as compared to kind of just really testing hypotheses and really kind of sorting out what is a real metric of til cell potency.
Operator: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. We ask that you please limit yourself to one question and then you may re-answer the queue. If time permits, we will take any additional questions.
I think that includes both of those components Madhu, it's it's it's a discussion about.
Mara Goldstein: Oh, thanks very much for taking the question. So, I just wanted to go back for a second to the question of the discussion with FDA, and I respect that there's very little that you can say about it, but, you know, the press release makes reference to still being able to come up with a solution that will satisfy the agency, and so I'm wondering if you could maybe share that with us. You know, where you are in the process in terms of the discussion level with them, you know, the original plan had been that you had some assays already on hand and that you also were pursuing a development track for new assays and would present those to the agency. So maybe, you know, because we're just about anniversarying this, maybe you can kind of walk us through exactly where things are at. Sure.
Frederick G. Vogt: Sure, Mara, that was the plan as we discussed back in June, and that's still the plan. We're just, right now, in the middle of the second half when we're having those things with the FDA and those regulatory discussions.
Frederick G. Vogt: Sorry, I was going to say, is it fair to characterize that you're still in a back and forth with the agency?
Thank you.
Next question comes from the line of choline coffee with Baird.
Frederick G. Vogt: Yeah, you can call. I mean, we would describe it as engagement, but yes, we're in the process of having that kind of relationship with them. And again, the anticipated BLA filing timeline is still the first half.
Yeah.
Great. Thanks, so much for taking my question too is it fair to assume that the third more novel potency assay is really the lead at this point that you were discussing with the FDA and when might me when might we get more information on what that is.
Mara Goldstein: Okay, and I know I appreciate the discussion around the activities that companies are undertaking and in advance of being able to submit, and I'm speaking, you know, from a commercial perspective, but relative to the capital that the company raised ahead of being able to, ahead of launching, and where you are now, I'm just curious about how much capital is being deployed while you are waiting that you would otherwise not spend.
Yeah currently we haven't disclosed the detail yet, although obviously when we talk about the concept. So as we talk often about the most recent assay or set of assets like technologies that we've developed.
I really can't say, what the lead is at this point.
We're the new assay technology is something that we think is the right answer theft his questions alone or or perhaps in combination with other other assessments that were already making.
Oh I don't know when we can disclose it remember that all these discussions are in confidence with FDA and the technology itself is proprietary so.
Frederick G. Vogt: Well, we're continuing to run our research and development program as we would normally have spent it. So we have all the clinical assets still progressing. We're just running this in parallel, so I wouldn't characterize it that way. I would basically say we're continuing the development of the TIL platform as we intended. At the same time, we're working with FDA on moving forward from the potency assay situation, which is something that we think is a gating item across the retail platform right now.
Immediately we won't be able to disclose it I hope that we can disclose at some time and in there you know near to mid future.
Certainly we would want to put it out there.
We're aware of how it works.
Great. Thanks, and then one more quick one on the upcoming presentation to T. J, what tumor types will be included in the frontline Pete Hambro combo.
We haven't disclosed that yet the abstracts were under embargo right now so that'll that should be available on November 9th in the morning, when the abstracts come out you'll be able to say more about that.
Great. Thank you.
Thank you and our next question comes from the line of Ben Burnett with Stifel.
Mara Goldstein: Okay, I really appreciate it. I'll hop off and let others ask questions. No problems, thank you.
Hi, This is Kelly breeze on for Ben Burnett. Thanks for taking my question I just had one quick one.
Operator: No problem. Thank you, Mara.
Michael Jonathan Yee: Thank you. And our next question comes from the line of Michael Yee with Jeffrey. Hey Fred, thanks and I appreciate the question. My question is, if you feel that you can reiterate the filing guidance today, what are you specifically waiting for? Is it an official sign-off on the assay? Is it the meeting minutes? Do you have a good sense of what is actually going to be measured? Can you just give us a sense of the fact that you feel very good about that, and perhaps you're just waiting for the meeting minutes? I guess that's question one. And then question two is, would you press release this announcement? Tell us what would happen, and what would need to happen after that to actually file.
Frederick G. Vogt: Thank you. Sure. Thanks, Michael. Let me take them in reverse order.
Frederick G. Vogt: When material information is available to us, for example, responses from the FDA that are clear, and the press release goes out on the basis of, I think we would try to do that. We would very much like to update the market as soon as we can about the situation with the FDA and our boat in Seattle. Turning to your first question, it's a very detailed, long engagement that we're, you know, it's a six-month process here, and it could go beyond that, of course, into 22.
Completely heard the question can you can you repeat that.
Yes sure.
It's about the ongoing patient assessment of efficacy assessment in melanoma cohort four and specifically in our patients be called in for a loss scan to ensure inclusion of contemporary data and the DLA.
And how does the timing for collection of clinical data later resolution of potency given that we often hear it takes three months to read and clean data through Central review.
Okay.
Yeah.
Thanks.
Yeah. So.
Frederick G. Vogt: We never said... We might have continuing stuff spill over in the early 22 as we sort this out, but nevertheless, sort of the blow-by-blow of things with the FDA. Yes, there are things like minutes. Yes, there are responses from the FDA and that sort of thing. We're not particularly waiting on anything right now. We'll update you when we can based on the disclosures that we have available to us at the time. Thank you. And our next question comes from the line of Mark Breidenbach with Oppenheimer. Hey guys, Matt on for Mark. Thanks for the question.
This is going a little bit into the inner workings of preparing a data cut for a single arm response rate endpoint trial.
We would not call patients in specific before an assessment. This is not an overall survival trial or oftentimes you you're doing overall survival call as you're getting closer to the data cut we are continuing to assess patients that are ongoing.
Indeed, predefined assessment schedule for the for the C. T scans and then we're defining a data cutoff date.
Everything up to that data cutoff date would be included in the analysis and you usually choose the data cutoff date to allow for sufficient time that then would allow you to clean the data prior to what we call the database lock.
Mark Alan Breidenbach: Hey guys, Matt on for Mark. Thanks for the question. Apologies if this has been asked before, but I'm just trying to think of worst-case scenarios here on the potency assay and path. Have we ruled out FDA asking you for a randomized trial in order to support initial approval? Is that something that's been discussed, or is that completely out of the question?
And that is still about two to three month time frame that you that you mentioned that can be shorter can be longer depending on what you think you need. So so that can be done without calling patients in specifically for an assessment, which would probably not be appropriate because if what you're asking for additional scans more frequently.
Then predefined and what they accrete to them there is constant.
I answer a question.
Yes.
It does and then I guess the question is then the timing of that defined.
Frederick G. Vogt: Yeah, thanks. While we can never say what FDA truly might want at the end, right now, FDA is not asking for that. So the way we've been treating this entire interaction with FDA is on the basis that we would be able to use the cohort for pivotal study data that we've already generated. Thank you. And our next question comes from the line of Asthika Goonewardene with Truist Security. Hi, this is Bill Onn for Asthika.
They are finding the cutoff date.
You are in the potency issue.
Resolution of the policy issue.
Something has to be rate limiting I guess, you don't want the clinical data to be rate limiting.
Yeah, although they can do they can run in parallel to some extent because.
Asthika Sarith Goonewardene: We just had a couple of questions. We heard from some comments from another telecompany that the FDA has accepted their proposed potency assays, and we were wondering if the FDA is giving you any guidance as to what components of their assays were viewed favorably or any suggestions. And how does what you have in development compare to that, in case you do have any guidance? Yeah, good question.
Frederick G. Vogt: Yes, there's been some comments by a competitor about this regarding a pre, you know, pre-I&D meeting, and I believe a pre-I&D meeting and then definitely an I&D meeting. At that stage of development, things are much, much, more lightweight in terms of what you have with FDA. We've been engaged with FDA for a long time on these things, and we've got a lot of detail from them about this. We don't really think there's any crossover between the two.
Is that we're showing them right now.
Some of them like the newer ones do have IP associated with them that might create.
Some barriers to entry for others, which we think is valuable.
Others are more generic assays that have been out there for a while.
<unk>.
May not provide as much protection, if you know what I mean.
Frederick G. Vogt: FDA is not really supposed to tell you what other sponsors are doing anyway. What we think our assay technology, the most recent assay technology that we've developed, does answer the question of how to show it. Pharmacotherapy consistent with the mechanism of action of that therapy.
And then you talked about.
<unk> is this.
Refinement as you go from <unk>.
One to step two step three or is it kind of.
Rejects.
All of them in one you've had to kind of come back with two and three.
That worked out.
Yes, I wouldn't treat them as refinements some of them are completely new approaches.
Asthika Sarith Goonewardene: Great, thanks. And I guess just one more on the LUN202 study.
Yeah.
One of the ones that we're most focused on right now as well.
Asthika Sarith Goonewardene: Would you be able to contrast both the enrollment rate and the number of patients you have recruited so far based on PD-L1 expression levels? So below 1% and above 1% to 49%.
But we were talking about earlier with the question.
Or really new technologies or new ways of looking at.
Hill's work, how the mechanism of action until it can be reflected in the potency assay.
So that's more of the.
I wouldn't treat them as requirements at all really wait when you're doing something like that there are some of the earlier assets might be viewed as sort of variations of each other but the new stuff that we're doing is really fundamentally no.
Friedrich Graf Finckenstein: The two cohorts. Frederick, do you want to answer that one? Sure, this is Frederick.
Got you and you feel that kind of each step is going to kind of get you closer.
Friedrich Graf Finckenstein: Thanks for the question. I don't think that at this time we would be commenting on the number of enrolled patients. Remember, the study is designed to enroll patients who have failed one line of prior chemo immunotherapy combination in two different cohorts, cohorts one and cohort two. I would expect, since the available care for these patients is similar, that the distribution across the two cohorts would be reflective of the distribution of the PD-L1 status in the population, which you can assume is about one-third and two-thirds. But again, I don't think that we're going to comment on the exact enrollment number or distribution at this time.
With the FDA or has it accelerated recently.
Any kind of sensitive.
Speed of progress would be.
Madhu Sudhan Kumar: And our next question comes from the line of Madhu Kumar with Goldman Sachs. Yeah, thanks for taking our questions.
Madhu Sudhan Kumar: Um, yeah, thanks for taking our questions. So as we think about kind of the potency assay situation, to what extent is this kind of a process of negotiation of kind of like sorting out your views on what are kind of relevant potency assays versus what the regulators take as compared to kind of just really testing hypotheses and really kind of sorting out what is a real metric of till cell potency? I think it includes both of those components, Madhu.
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Frederick G. Vogt: It's a discussion about the mechanisms of action of pills and how potency assays can reflect that, and then specifically how assays that we've developed work, how they assess, we think, accurately, the potency of TILT therapy. FDA issued guidance in 2011 on this, as you guys know. A lot of the detail of that guidance is wrapped up in these sort of discussions. We are in a pretty advanced state. Since we've got these methods and we've got data, and we've got things we can talk about with FDA, so a lot of that's part of the discussion as well.
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Madhu Sudhan Kumar: And then how much lead time do you think you would need to actually get resolution of the potency assay before you could feel confident maintaining this first half 2022 guidance? Like if it's March of next year and you guys haven't reached resolution, would that be kind of like, what's the bound in which you would try to push back the timing of potentially a BLA from first half 2022? We don't know exactly.
Madhu Sudhan Kumar: We are able, because a lot of the things we're doing right now are enabling us to file a BLA, to sort of do two things at once. We can engage with FDA on the potency assay and prepare everything for the BLA. At some point, obviously, that could slip, but it's not something that I would worry about, at least initially, in the first half of next year.
Colleen Margaret Kusy: And our next question comes from the line of Colleen Kusy with Baird.
Colleen Margaret Kusy: Great, thanks so much for asking your question. So is it fair to assume that the third more
Frederick G. Vogt: The third, more novel potency assay is really the lead at this point that you're discussing with the FDA, and when might we get more information on what that is? Yeah, Colleen, we haven't disclosed the details yet. Although, obviously, when we talk about potency assays, we often talk about the most recent assay or set of assay technologies that we've developed, I really can't say what the lead is at this point.
Colleen Margaret Kusy: The new assay technology is something that we think is the right answer to FDA's question, alone or perhaps in combination with other assessments that we're already making. But I don't know when we can disclose it. Remember that all these discussions are in confidence with FDA, and the technology itself is proprietary. Immediately, we won't be able to disclose it. I hope that we can disclose it sometime in the near to mid-future, and then certainly we would want to put it out there so that more people are aware of how it works.
Frederick G. Vogt: Great, thanks. And then one more quick question on the upcoming presentation at FITC: just what tumor types will be included in that frontline-peat-pembro combo? We haven't disclosed that yet.
Frederick G. Vogt: We haven't disclosed that yet. The abstracts, we're under embargo right now, so that should be available on November 9th in the morning when the abstracts come out.
Frederick G. Vogt: You'll be able to see more about that. Great, thank you. Thank you. And our next question comes from the line for Ben Burnett with Stiefel. Hi, this is Kaylee Breeze. I'm from Ben Burnett. Thanks for taking our question.
Benjamin Jay Burnett: I just had one quick question. We were just wondering if you could give us any guidance or any details about when we might see some data for TILS using Gen 3 manufacturing.
Frederick G. Vogt: See some data for TILS using the Gen 3 manufacturing process for any of the indications that it's being explored in. Thank you. That's something we're looking at as soon as we can. Right now, I can't say anything about that, but stay tuned on that. Well, we are interested in trying to get that data out so we have something meaningful to report.
Benjamin Jay Burnett: Okay, thank you so much.
Operator: Thank you. And our next question comes from the line of Nick Abbott with Wells Fargo.
Nick Abbott: Pardon me, Nick, please check your mute button. Sorry about that. Yes, thank you. Can you talk about the ongoing patient assessment for melanoma cohort 2? And specifically, will patients be called in for a last scan to ensure inclusion of contemporary data with the BLA? And how does the timing for collection of that clinical data relate to resolution of this potency issue? You know, given that we often hear it takes three months to read and clean clinical data through a central review. Yeah, Nick, I think you're referring to cohort four, right? Oh, sorry. The melanoma BLA cohort.
Nick Abbott: The whole cohort, yes. Apologies. Frederick, could you answer that one?
Friedrich Graf Finckenstein: I completely heard the question. Can you repeat that? Yeah, sure. So, you know, it's about the ongoing patient assessment and efficacy assessment in melanoma cohort four. And specifically, you know, will patients be called in for a last scan to ensure inclusion of contemporary data in the DLA? And how does the timing for collection of clinical data relate to resolution of potency, given that we often hear it takes, you know, three months to read and clean data through central review? Yeah, I understand. Thanks.
Nick Abbott: Yeah, so... This is going a little bit into the inner workings of preparing a data cut for a single-arm response rate endpoint trial. However, we would not call patients in specifically for an assessment.
Friedrich Graf Finckenstein: This is not an overall survival trial, where oftentimes you do an overall survival call as you're getting closer to the data cut. Instead, we are continuing to assess patients that are ongoing in the predefined assessment schedule for the CT scans. And then we define a data cutoff date, and everything up to that data cutoff date would be included in the analysis. And you usually choose that data cutoff date to allow for sufficient time that then would allow you to clean the data prior to what we call the database lock. And that is still about the two to three months' time frame that you mentioned. It can be shorter, it can be longer, depending on what you think you need.
Nick Abbott: So that can be done without calling patients in specifically for an assessment, which would probably not be appropriate because it would be asking for additional scans more frequently than predefined and what they agreed to in their consent. Did that answer your question? Yeah, it does. And then I guess the question is, you know, then the timing of that, defining the cutoff date versus where you are on the potency issue. Resolution of the poverty issue
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Nick Abbott: If something has to be rate-limiting, I guess you don't want the clinical data to be rate-limiting, Yeah, although they can run in parallel to some extent, because we could be doing IRC work while we're resolving the potency assay issue. And then, sort of, at the end of that process, as we've discussed on a lot of our calls, go back and revisit the full analysis set, as opposed to having the information in hand. Okay, that makes sense great. Thank you. Thank you.
Peter Richard Lawson: Before we continue, if you have any additional questions, please press star 1. Our next question comes from the line of Peter Lawson with Barclays. Great, thanks for taking my questions. Just on the potency assays, just, I guess, how many potency assays do you think you need? And do you have, and then.
Frederick G. Vogt: Well, how many of those do you think you could essentially have patent protection around? [inaudible] to preclude other users? Yeah, good question, Peter. We have a lot of them.
Peter Richard Lawson: I don't have an actual final number of them because there are so many variations. It's really a rather complicated environment, but we've shown multiple assays to the FDA. As most of you know, we're on our third assay or set of assays that we're showing them right now. Some of them, like the newer ones, do have IP associated with them that might create some barriers to entry for others, which we think is
Frederick G. Vogt: Others are more generic assays that have been out there for a while that may not provide as much protection. And then you talk about three sets of essays, refinement, as you go from step one to step two to step three, or as they've kind of... rejected all of them in set one, and you've had to kind of come back with a set two and then a set three. How did that work?
Peter Richard Lawson: Yeah, I wouldn't treat them as refinements. Some of them are completely new approaches. One of the ones that we're most focused on right now is what we were just talking about earlier with the question, which are really new technologies or new ways of looking at how PILs work, and how the mechanism of action of PILs can be reflected in the low-potency assay. So that's more of the. I wouldn't treat them as refinements at all, really.
Frederick G. Vogt: There are some of the earlier athletes might be viewed as sort of variations of each other, but the new stuff that we're doing is really fundamentally new. And you feel that kind of each step is going to kind of get you closer to the FDA, or has it accelerated recently or any kind of sense of Speed of Progress. So we feel like we're making progress, and it's good enough that we can continue to guide towards the first half of the 2022 BLA file, which is coming up fairly soon here. So we're comfortable with where we are right now with FDA. There's work to be done, and we're still working. That's, you know, as things stand today; we're standing by that guy.
Peter Richard Lawson: Great. Thank you so much. Thank you. And I'm showing no further questions.
Frederick G. Vogt: So with that, I'll turn the call back over to Fred for any closing remarks. Thank you again for joining the Iovance Biotherapeutics Third Quarter 2021 Financial Results Conference. I'd like to thank our investors, analysts, patients, collaborators, and employees for their support. Please feel free to reach out to our investor relations team if you wish to follow up. Thanks, everyone. This concludes today's meeting. Thank you for participating, and you may now disconnect.
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