Q2 2021 Iovance Biotherapeutics Inc Earnings Call

[music].

Welcome to the <unk> Biotherapeutics second quarter 2021 financial results. My name is Josh and I will be your operator for today's call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session. During the question and answer session. If you have a question. Please.

Operator: Welcome to the Iovance Biotherapeutic second quarter 2021 financial results. My name is Josh, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. During the question-and-answer session, if you have a question, please press STAR>, then the number on your touchstone telephone.

Press Star then the 1 on your Touchtone telephone. Please note that this conference is being recorded I will now.

Sara Pellegrino: Please note that this conference is being recorded. I will now turn the call over to Sarah Pellegrino, Vice President, investor in public relations at Iovans. Sarah, you may begin.

Ill turn the call over to Sara Pellegrino, Vice President Investor and public relations of Ireland's Sir you may begin.

Thank you operator, good afternoon, and thank you for joining us.

Sara Pellegrino: Thank you, Operator. Good afternoon, and thank you for joining us. Speaking on today's call are Fred Vote, our interim president and chief executive officer; Igor Balinski, our chief operating officer; and Jim Ziegler, our senior vice president of commercial.

On today's call, we have Brad <unk>, our interim President and Chief Executive Officer, Igor Balinsky, Our Chief operating Officer, Jim Ziegler, Our senior Vice President commercial Dr. Greg Finkelstein, our Chief Medical Officer, and John Marc <unk>, Our Chief Financial Officer, Dr. <unk> <unk>.

Sara Pellegrino: Dr. Frederick Sinkinstein, our chief medical officer, and John Mark Delameen, our chief financial officer. Dr. Madan Gagetia, our senior vice president of medical affairs, is also on the call to participate in the question and answer session. 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 six months ended on June 30, 2021, as well as corporate up, 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, free 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.

Senior Vice President Medical Affairs also on the call to participate in the question and answer session.

This afternoon, we issued a press release that can be found on our web site <unk> dot.

Which includes the financials as adults for the 3 and 6 months ended on June 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 idled answered schools at Muskogee business, Glenn pre commercial activity.

Clinical trials regulatory plans and results.

Future applications of our technology and you've actually capability.

<unk> feedback and guidance payer interaction collaboration cash position in the expense guidance and future updates.

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.

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 SAC filings. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward-looking statement. With that, I will turn the call over to Thread.

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 Brad.

Thank you Sarah and good afternoon, everyone.

Frederick G. Vogt: Thank you, Sarah, and good afternoon, everyone. I am pleased to highlight our progress in the second quarter and first half of 2021 at I advance during today's conference call. During this year, we have continued to advance our tumult trading lymphocyte, or TIL, pipeline. We've reported clinical data across our metastatic melanoma program, including our first clinical data in early line melanoma, as well as new indications such as metastatic non-small cell lung for our lead co-product candidate, Luceol, and Metastatic Melanoma. However, our top priority remains our ongoing work to address FDA feedback regarding the potency assays for Life of Lusole to support our plan to be

I'm pleased to highlight our progress in the second quarter and first half of 2021. It is answering today's conference call.

During this year, we have continued to advance our tumor infiltrating lymphocyte or til pipeline.

We've reported clinical data across her metastatic melanoma program, including our first clinical data in an early line melanoma as well as in new indications such as metastatic non small cell lung cancer.

For our lead product candidate price Luzon metastatic melanoma, our top priority remains our ongoing work to address FDA feedback regarding the potency assays for life of Lusaka support our planned BLA submission.

We're confident in our ability to address fda's feedback and complete our work on additional assays in a timely manner.

We are engaged in an ongoing dialogue with the FDA that we plan to continue into the second half of the year to support a BLA submission in the first half of 2022 as guided.

Evolution of the potency assays is also an important next step towards the progress in our other late stage clinical programs.

Turning to our clinical pipeline updates, we now have clinical data showing the problems with til therapy in 4 different solid tumors place.

Cross bearish treatment settings, furthering our confidence until the broad platform and net cliff in cancer treatment.

Frederick G. Vogt: We're confident in our ability to address FDA feedback and complete our work on additional assays, and it timely matters. We're engaged in an ongoing dialogue with the FDA that we plan to continue into the second half of the year to support BLA submission in the first half of 2022 as guided. Resolution of the Poet and the Act is also an important next step towards progress in our other late-stage clinical programs.

Frederic will summarize the key updates in a moment, but overall, we are really excited about 3 key takeaways.

First our initial data in metastatic non small cell lung cancer demonstrated 21, 4% overall response rate in a heavily pretreated patient population.

All of them have progressed on prior immune checkpoint inhibitor or ICI therapy, which represents a significant unmet need patient population and non small cell lung cancer.

Next life loophole in post anti PD, 1 melanoma continues to show increasing long term durability.

And third the initial results of the local loop on combination with pemble isn't that showed an 86% overall response rate, including a 43% complete response rate and anti PD, 1 naive melanoma patients.

Frederick G. Vogt: Turning to our clinical pipeline updates, we now have clinical data showing the problems with telling therapy and four different solid tumors, prosperous treatment settings, further increasing our confidence until as a broad platform and next class can. Frederick will summarize the key updates in a moment, but overall, we are really excited about three key takeaways. First, our initial data and metastatic non-small lung cancer demonstrated its 21.4% overall response rate in a heavily pre-treated patient population, all of whom have progressed on fire immune checkpoint inhibitor or ICI therapy, which represents a significant unmet need in the patient population and non-small cell lung cancer. Next, Lifluosin post-anti-P2 melanoma continues to show increasing long-term durability. And third, the initial results for Lifluol and combination with Kermalizumab showed an 86% overall response rate, including a 43% complete response rate in anti-P1 naive melanoma patients.

Of course, our broader strategy to combine Ivy Hill with available therapies to move into earlier treatment settings in solid tumors.

On the research side, we are bringing the next generation of til and supporting therapies in the clinic.

As we noted in today's press release, we are advancing COVID-19 the genetically modified the knockout PD 1.

Which we have designated <unk> 4001.

Swells our novel IL 2 analog.

3001.

Both Iot 4001 in IV 3000 wanted 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 cancer patients and I'm very confident in the quality of our senior leadership as well as our full internal organization to deliver towards this mission.

Today, we have more than 270 employees, who on average have more than free and a half years itself therapy experience.

On the call today I would like to ask the members of our executive leadership team to provide updates for their respective departments, beginning with our chief operating officer Igor Belinda.

Thank you Fred.

To speak today about the progress of why advanced manufacturing and our in house manufacturing facility. All at once so cell therapy center or a C. D C at the Navy yard Philadelphia.

To date, nearly 500 patients have received items still with a continuing manufacturing success rate above 90%.

<unk> has transformed to manufacturing from a lengthy single center academic process to a shorter scalable centralized GMP process, yielding a club because their product shipment directly to sites, where the patients are treated.

Frederick G. Vogt: Of course, our broader strategy to combine I-Avance Hill with available therapies and move into earlier treatment settings and solid tests. On the research side, we are bringing the next generation of TIL and supporting therapies in those. As we noted in today's press release, we are advancing a tilde to genetically modify the knockout PD1, which we have designated Iov-201, weld our novel, Isle 2 Anel Both Iov E.V-401 and IovE-301 are progressing through IMD-enabling studies that are moving towards the clinic.

Our current Gen..2 process is 22 days.

We're also continuing to advance our leadership position.

We are already investigating in the clinic power Gen. III process, which is 16 days to further improve by events to manufacturing efficiencies and deliver items still to patients even sooner.

We believe that our jumped 316 day to many of the closest is the fastest in the industry at this point.

We're excited to be completing the commissioning of CDC, where all activities are proceeding as planned.

As noted in today's press release, we've received clearance and lumpy commenced clinical manufacturing and price you can see in the near future to supply investigational items, 2 therapies to cancer patients enrolled in our clinical trials.

Frederick G. Vogt: In summary, we continue to execute all development manufacturing on pre-commercial activities and further our commitment to address the critical needs of cancer patients. I'm very 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 270 employees who, on average, have more than three and a half years of self-therapy experience. On the call today, I would like to ask the members of our executive leadership team to provide updates for their respective departments, beginning with our chief operating officer, Igor Belin. Thank you, Fred.

In addition, we're now moving to commercial manufacturing readiness activities.

Items still.

You can see.

Commercial supply remains on track for 2022 with capacity to meet the demand of thousands of patients in multiple indications.

To support advanced 2 manufacturing capabilities and pipeline.

Have been sharply focused on building, a robust and growing intellectual property or a deep portfolio.

Our Gen..2 IP portfolio is covered with my more than 25 grants into a low U S and international patents with expected exclusively exclusivity through 2038.

In total we have more than 700, thousands and certain applications filed globally across major pharmaceutical markets and other key geographies.

All events of granted patents and patent applications include <unk>.

Igor P. Bilinsky: I'm pleased to speak today about the progress of Iovan's manufacturing and our in-house manufacturing facility, IAuban Cell Therapy Center or ICTC at the Navy YR Philadelphia. To date, nearly 500 patients have received Ivan still with a continuing manufacturing success rate above 90%. IVans have transformed till manufacturing from a lengthy, single-center academic process to a shorter, scalable, centralized GMP process, yielding a crowd-preserved product for shipment back to the sites where the patients are treated. Our current Gen 2 process is 22 days.

Physicians and methods of treatment in a broad range of cancers relating to the gen..2 manufacturing process.

Gen 3 minutes veteran selected til products steel products produced from core biopsies.

Stable and transient genetic modifications of til.

Tumor digest and pregnant compositions and methods, including cryopreservation.

Combinations of <unk> with.

With checkpoint inhibitors.

We believe that our internal manufacturing and IP position has firmly established our leadership in developing and delivering til therapies for patients with cancer.

I would now like to hand, the call to Jim Ziegler, our SVP commercial to highlight our commercial launch preparations Jim.

Thanks, Igor we continue our launch preparations with U S cancer centers payers and other key stakeholders in anticipation of our first BLA submission in the first half of 2022.

Igor P. Bilinsky: We are also continuing to advance our field leadership positions. We are already investigating in the clinic a Gen 3 process, which is 16 days, to further improve eye-event skill manufacturing efficiencies and deliver eye-event skill to patients even sooner. We believe that our 10-16-day film manufacturing process is the fastest in the industry at this. We are excited to be completing the commissioning of our ICTC, where all activities are proceeding as planned.

Our cross functional team is focused on operational excellence to ensure a strong month.

The commercial organization maintains our gated approach to commercial readiness and we are well positioned to scale our efforts based upon internal milestones and timelines.

Our medical Affairs team continues robust kols and clinical site engagement in preparation for commercial loans through education and scientific communication activities that are essential to building a strong foundation for launch.

Igor P. Bilinsky: As noted in today's press release, we have received IND clearance, and plan to commence clinical manufacturing at ICPC in the near future to supply investigational IVAN school therapies to cancer patients enrolled in our clinical trials. In addition, when I'm moving to commercial manufacturing readiness activities for Ivan still at ICDC, commercial supply remains on track for 2022, with capacity to meet the demand for up to thousands of patients in multiple indications. To support our Ivan Steel Manufacturing Capabilities and Pipeline, we have been sharply focused on building our robust and growing intellectual property or IT portfolio.

This team works closely with leading medical Association and partners with patient advocacy groups to increase awareness for our events, Phil and like will do so.

In addition, we have increased the scientific communication through the publication in high impact journals and presentations at leading medical meetings at Friedrich will cover in more detail.

Our commercial team is steeped in oncology and cell therapy experience.

We are partnering with the leading U S cancer centers to build their til service line capabilities.

We are also seeing a strong level of engagement and commitment by a significant number of sites.

As we approach our BLA submission, we will ramp up our training and Onboarding processes. So these sites are ready to treat patients upon approval.

I would like to recognize our public policy and market access teams, who are working to ensure timely and appropriate access per kill sell through.

Igor P. Bilinsky: Our Gen 2 IP portfolio is covered by more than 25 grandfut or allowed U.S. and international patents with expected exclusivity through 2038. In total, we have more than 700 patents and patent applications filed globally across major pharmaceutical markets and other key geographies. Our events granted patents and patent applications include compositions and compositions and methods of treatment in a broad range of cancers relating to the Gen 2 manufacturing process, Gen 3 Manufacturing, selected till products, till products produced from poor biopsies, stable and transient genetic modifications of TIL, tumor digest and pregnant physicians, and methods including cryopreservation, and combinations of Phil with checkpointing.

Specifically this week the centers for Medicare and Medicaid services or CMS.

Finalized its proposal to expand the existing M. N E. R. G 18 to include LIFO, Lusso and other cell therapies.

With this significant change we expect that our til centers will experience a much more stable and predictable Medicare inpatient reimbursement landscape.

In turn we anticipate that.

Medicare patients will have timely access to likely loosen.

We think key stakeholders, who supported this approach and appreciate the step CMS has taken to improve Medicare patient access to cell therapies.

We look forward to working with Siemens and other key stakeholders in the future as refinement may be needed for this emerging class of therapies.

In addition to CMS.

We continue to engage national and regional payers to ensure patients with private insurance will have timely and appropriate access to life the looser.

The team also remains on track to deliver Io Vance Carrington loans, which includes our proprietary chain of identity and chain of custody system.

Our fully integrated patient man, who can be an approach and our integrated approach to quality, our Io means care sell ordering platform and patient support programs reinforce our commitment to customer and patient centricity, which means understanding anticipating and addressing their needs I will now.

James Ziegler: We believe that our internal manufacturing and IT positions have firmly established our leadership in developing and delivering kill therapies for patients with cancer. I would now like to hand the call to Jim Ziegler, our SVP of commercial, to highlight our commercial launch preparations. Jim?

I'll pass the call to Friedrich to outline our clinical updates.

Thank you Jim.

I am pleased to highlight recent syndicated data update as well as the state of Ohio.

4 ongoing clinical studies.

James Ziegler: Thanks, Igor. We continue our launch preparations with U.S. Cancer Centers, payers, and other key stakeholders in anticipation of our first BLA submission in the first half of 2022. Our cross-functional team is focused on operational excellence to ensure a strong launch. The commercial organization maintains our gated approach to commercial readiness, and we are well positioned to scale our efforts based upon internal milestones and timelines.

Our adjusted development strategy focused on cancer populations with high unmet need with substantial up but to me until to make a meaningful impact.

Since he has held in recent conference calls to focus on the asphalt data and the non small cell lung cancer data will briefly recap the highlights.

First as Fred mentioned, our clinical data updates in plenary presentation at ACR and Ethel included lots of news flow in advanced melanoma patients who had progressed on anti PD 1 therapy.

So our first set of clinical data, but I said looser in combination with <unk> and then earlier treatment setting with net on the low patients who are naive to anti PD 1 therapy.

James Ziegler: Our medical affairs team continues robust KOL and clinical site engagement in preparation for commercial launch through education and scientific communication activities that are essential to building a strong foundation for launch. This team works closely with leading medical associations and partners with patient advocacy groups to increase awareness for Iovans, pill, and Lyphalus. In addition, we have increased scientific communication through publication in high-impact journals and presentations at leading medical meetings that Friedrich will cover in more detail. Our commercial team is steeped in oncology and stealth therapy, and we are partnering with leading U.S. Cancer Centers to build their TILS. service line capabilities

And post anti PD, 1 patients from cohort 2 and all of US who have won all 401 study. The long term follow up data showed an overall response rate or R. R of 36, 4% and median duration of response was still not reached at 33, 1 months of <unk>.

Let me follow up.

Results from additional analysis suggests that early intervention with nice day Lutheran at the time of day initial progression on anti PD, 1 therapy and they maximize benefit.

For the post anti PD, 1 patient population enrolled in cohort 2 chemotherapy the only currently available options.

It's a 4% to 10% response rate and overall survival of only 7 to 8 months.

Well, it's T O L continued to be very enthusiastic about the durability of response following onetime treatment with like the looser and be very difficult to treat metastatic melanoma patients.

We are very excited about the high impact publications of our cohort 2 data in <unk> in May 2021.

Within that accompanying editorial that outlines the transformative potential of til therapy.

Vacation will further help communicate all of the melanoma data to abroad international audience of oncologists.

Also as Covid initial clinical data from 7 anti PD, 1 therapy naive melanoma patients in cohort 1 a of the Iot.

James Ziegler: We are also seeing a strong level of engagement and commitment by a significant number of sites. As we approach our BLA submission, we will ramp up our training and onboarding processes so these sites are ready to treat patients upon approval. I would like to recognize our public policy and market access teams for working to ensure timely and appropriate access for TILFELP. Specifically, this week, the Centers for Medicare and Medicaid Services, or CMS, finalized its proposal to expand the existing MS DRG 18 to include lifelong learning and other cells. With this significant change, we expect that our TIL centers will experience a much more stable and predictable Medicare inpatient reimbursement landscape at Lone. In turn, we anticipate that

202 study suggests that the response rate for life at Lutheran combination with 10 per Elysium up may be additives.

6 of the 7 patients had a confirmed objective response, representing an 86 per cent or including 2 complete responses.

Our 1 unconfirmed PR or CR and the patients who have not yet reached the confirmatory T O.

But being named in follow up.

3 partial responses PR and 1 best response or stable disease.

Responses deepened over time.

And you are.

Rate was 43%.

We're very excited about these data and look forward to seeing longer follow up as well as data in additional patients.

There was a need to improve overall response rate and deepen responses with more complete responses.

Anti PD, 1 naive metastatic melanoma, where populism alone.

33% response rate with only 6% complete responses.

We're 40 to 65 per cent of patients has primary.

Young checkpoint inhibitors or ICI.

For our non small cell lung cancer program, we provided a corporate update with clinical data for our til therapy, and then 1 for clay and patients with metastatic non small cell lung cancer, who enrolled in cohort 3 D of the ongoing basket study ILD come 2 or 2.

James Ziegler: Medicare patients will have timely access to life relief. We thank key stakeholders who supported this approach and appreciate the steps CMS has taken to improve Medicare patient access to self-reactors. We look forward to working with CMS and other key stakeholders in the future as refinements may be needed for this emerging class of therapy, in addition to CMM. We continue to engage national and regional payers to insure patients with private insurance will have timely and appropriate access to life solutions.

<unk> 3 D and hold 28 patients that have progressed on prior immune checkpoint inhibitor or ICI therapy.

But it's important to note that this was a heavily pretreated population.

24 of the 28 patients or 85, 7%, including all the sponsors have received 2 or more plier line growth.

That makes therapy.

A significant unmet needs to increase response rates and prolonged survival in this difficult to treat.

CLC population. So we were very pleased to see in all our of 21, 4%, including 1 confirmed complete response and 5 confirmed partial responses with <unk>.

James Ziegler: The team also remains on track to deliver Iovans Cairs at launch, which includes our proprietary chain of identity and chain of custody systems, our fully integrated patient management approach, and our integrated approach to quality. Our Iovans Care Cell Ordering Platform and Patient Support Programs reinforce our commitment to customer and patient centricity, which means understanding, anticipating, and addressing their needs. I will now pass the call to Friedrich to outline our clinical update.

Before 30% disease control rate and median duration of response that had not been reached at $8..2 months of median study follow up.

Historically, all of approximately 20% while reported with ICI second line therapy, and ICIS naive patients who had progressed on frontline chemotherapy. So we are pleased to see a comparable or pick up patients in cohort 3 D who has always seen prior anti PD 1 therapy.

We are confident in our non small cell lung cancer development strategy.

Turning to our ongoing clinical studies.

James Ziegler: Thank you, Jim. I am pleased to highlight recent clinical data updates as well as the status of our four ongoing clinical studies. Our job development strategies focus on cancer populations with high unmet need, with substantial opportunities for Jill to make a meaningful impact. Since we have held recent conference calls to focus on the astro data and the non-small lung cancer data, I will briefly recap the highlights, first as

<unk> continues to recruit patients across 4 clinical trials with I O than kill.

Or potentially registration supporting iOS and.

And 2 are 2 study in second line lung cancer, we have dosed the first patient and now activated a total of more than 50 insight.

We believe that the patient population and the 3 <unk> and 2.2 cohorts, including a cohort using core biopsies.

The 3 non small cell lung cancer cohort and the basket study the low.

All of us to broadly address the unmet need coming on small cell lung cancer.

Recruitment also continue.

Friedrich Graf Finckenstein: Our clinical data updates in plenary presentations this year at AACR and ASCO included Lysolucle in advanced melanoma patients who had

<unk> come to who basket study of idled until until plus ICI combinations across melanoma head and neck and non small cell lung cancers.

In L. A C 145, or 4 clinical study and have cervical cancer. We continue to recruit a cohort of patients not previously treated with standard chemotherapy or anti PD, 1 to receive I owe them til plus computers.

Friedrich Graf Finckenstein: who had progressed on anti-PD-1 therapy. And at ASCO, our first set of clinical data for lyselucidin combination with penlylysmart in an earlier treatment setting for melanoma in melanoma patients who were not used to anti-PD-1 therapy. In post-anti-PG1 patients from cohort 2 in our C-14401 study, the long-term follow-up data showed an overall response rate, or ORR, of 36.4%, and median duration of response was still not reached at 33.1 months of median study follow-up.

We are also actively enrolling in our ILD.

Zero, 1 a b and C N O F L X.

Patients.

We hope to be able to provide additional data from these studies at future medical meeting.

I will now hand, the call over to Mark to discuss our second quarter 'twenty to 'twenty 1 financial results.

Thank you reported.

My comments will reflect the high level financial results for the second quarter of 2021.

Additional details can be found in this afternoon's press release as well as you know our SEC filings.

I will begin with our cash position.

As of June 20 kept you warm.

Everyone's L $787 million in cash cash equivalents investments and restricted cash.

<unk> 655 million Daus on December 31st 2020.

Friedrich Graf Finckenstein: Results from additional analyses suggest that early intervention with Lyso at the time of initial progression on anti-PD1 therapy may maximize benefits. For the post-anti-PD1 patient population in Walton Corps 2, chemotherapy is the only currently available option and offers a 4 to 10% response rate and overall survival of only 7 to 8 months. We, as well as KOL, continue to be very enthusiastic about the durability of response following one-time treatment with Lyso Lyslind in very difficult to treat metastatic melanoma patients.

Our strong cash position is expected to be sufficient.

Well into 2020.

2 events or operating plan, including pipeline development commercial manufacturing readiness and loans put divisions.

Moving on to the income statement.

Net loss for the second quarter ended June 30, you can see.

1 was $81.4 million daus.

You can pretty cents per share.

Net loss of $63 million or 47 per share.

The second quarter of June 30.

Yeah.

Net loss for the 6 months ended June 30.

<unk> was 1 of the $6 million.

Friedrich Graf Finckenstein: We are very excited about a high-impact publication of our cohort 2 data in JCO in May 2021, with an accompanying editorial that outlines the transformative potential of kill therapy. This publication will further help communicate our melanoma data to a broad international audience of oncologists. Also at ASCO, the initial clinical data from seven anti-PD1 therapy naive melanoma patients in cohort 1A of the IOV, Com.2 study suggest that the response rate for lightenutal is higher than for other drugs.

1 point to all 4 adult all per share.

The net loss of $156 million or 1 <unk> per share.

Same period ended June 30.

Research and development expenses were 52 per $1 million for the second quarter on the Jupiter.

An increase of $12.8 million.

9.

For the second quarter.

Jude J T.

Yeah.

Research and development expenses were 118 per 1 million daus.

For the 6 months ended June 32021, an increase of $11.8 million compared to $106.

Friedrich Graf Finckenstein: and luthal in combination with temporalismat may be additive. Six of the seven patients had a confirmed objective response, representing an 86% ORR, including two complete responses, or CR, one unconfirmed CR, or UCR, and a patient who had not yet reached the confirmatory CR assessment but remained in follow-up, three partial responses, or PR, and one death response of stable disease. Responses deepened over time, and the CR and UCR rate was 43%. We are very excited about these data and look forward to see a longer follow-up, as well as data and additional patient, There is a need to increase overall response rate and deepen responses with more complete responses in anti-PD1, naive metastatic melanoma, where Pamprolizumab alone yields a 33% response rate with only 6% complete responses, and where 40 to 65% of patients have primary resistance to immune checkpoint inhibitors or ICI.

Okay.

For the same period ended June 32012.

The increase in research and development expenses.

Quarter, 1.2 to 1 over the prior year period was primarily attributable to growth of the internal research and development zone.

An increase in cost related to manufacturing and our internal ICT some facility.

The increase in research and development expenses in the first half.

Although the prior year period was primarily attributable to growth of the internal research and development team and costs related to the completion of construction, although ICT T cells.

Which were partially offset by lower manufacturing and clinical costs.

Following the completion of enrollment in several calls for melanoma and cervical trucks.

General and administrative expenses were 19 million.

For the second quarter ended June 30.

2.1.

The acquired loans.

Roll off compared to $44 million for the second quarter ended June 32013.

General and administrative expenses were $48.9 million Covid.

Most of the June 32021.

The $10.7 million daus.

Yeah.

For the same period ended June 30.

2020.

The increase in general and administrative expenses.

Second quarter, and first half of 2021 compared to the Premier European yields were primarily attributable to growth of Greenfield dollar general and administrative team.

Friedrich Graf Finckenstein: For our non-small lung cancer program, we provided a corporate update with clinical data for our TIL therapy, LN145, in patients with metaphatic non-small lung cancer who enrolled in cohort 3B of the ongoing basket study Iov Com202.

The higher stock based compensation expenses.

As of June 30, 2021 they were approximate people wanted to live in 55 million common share outstanding.

We continue to focus on investments in 4 key areas that was outlined previously to ensure the growth and strength of our value creation.

Which our advancement in expenses for clinical pipeline launch readiness with strong cash position and their transition from construction to commencement of manufacturing with ICT.

Friedrich Graf Finckenstein: who are 3B enrolled 28 patients that have progressed on prior immune checks

I remain confident that by managing our investments across these priorities will be.

Continue to stay focused in the line of studying with the appropriate price.

Friedrich Graf Finckenstein: Immune Checkpoint Inhibitor or ICI therapy.

I will now end the call back to the operator to kick off the Q&A session.

Friedrich Graf Finckenstein: But it's important to note that this was a heavily pre-treated population.

Thank you.

A reminder to ask a question you will need to press star 1 on your telephone to withdraw your question press the pound key please limit yourself to 1 question. Please standby, while we compile the Q&A roster.

Friedrich Graf Finckenstein: 24 of the 28 patients, or 85.7%, including all responders, had received two or more prior lines of systemic therapy. There is a significant unmet need to increase response rates and prolong survival in this difficult-to-treat NSCL population. So we were very pleased to see an ORR of 21.4%, including one confirmed complete response and size confirmed partial responses, a 64.3% disease control rate, and median duration of response that has not been reached at 8.2 months of median study follow-up.

Our first question comes from Michael Yang with Jefferies. You May proceed with your question.

Hi, guys. Thank you.

Congrats on the progress and thank you for the question.

Got a question on clarifying the next steps on the potency assay.

When you say, you're going to submit data and meet with the FDA.

By the end of the year can you walk through it.

Generally what youre focused on submitting and then when you submit it do you have to wait a certain number of days to get a meeting and then you have to wait for the meeting minutes, and then update us and therefore would that fall into actual calendar 2022, maybe just walk through the chronology of how that works.

Because that would explain when you'd be able to come back to the street and tell us the next steps. Thank you.

And Michael as Fred I can answer that for you.

It's the.

The FDA interaction processes.

Friedrich Graf Finckenstein: Historically, OORs of approximately 20% have been reported.

We're not disclosing the details of what we're doing right now with the FDA, but in general as you know there is different types of meetings you can hold with the FDA they have.

Friedrich Graf Finckenstein: were reported with ICI as second-line therapy in ICI-nais patients who had progressed on frontline chemotherapy. So we are pleased to see a comparable OR in sicker patients in cohort 3B, who have all received prior antipD1 therapy, and we are confident in our non-small lung cancer development strategy.

Submission timelines and the FDA responds after those timelines when you hosted a meeting for example for a type a meeting its 30 days for a type B meeting its 60 day should get feedback from the EF day ahead of the meeting you had the meeting and it typically 30 days later you get a.

A written response from FDA for most of these categories.

We're not we're not disclosing any of the details of exactly what we're doing right now with the FCA, but but we are executing on the plan that we described earlier, which is to have these interactions in the second half of 2021, which is which we're in right now so.

Friedrich Graf Finckenstein: Turning to our ongoing clinical studies, we continue to recruit patients.

Friedrich Graf Finckenstein: across four clinical trials with Iovans killed, in our potentially

So please stay tuned and we'll.

As soon as we can get some information that we think is.

Friedrich Graf Finckenstein: registration supporting the I-O-W-L-O-2 study in second-line Lungan

We think is significant and we can communicate we will certainly be communicating it.

But to clarify you would probably not come back to the street on what the result of this stuff is until after you've met with them and all of that which you're saying is by end of 'twenty..1. So if I just do math on that that's a calendar 'twenty 2 is that a fair conclusion.

No I don't think that's fair.

Friedrich Graf Finckenstein: We have done it.

Friedrich Graf Finckenstein: dose the first patients and have now activated a total of more than 15 sites. We believe that the patient population and the three I-O-V-L-U-2 cohorts, including a cohort using core biopsies, as well as

Well it could be.

Having interactions in 'twenty, 1 that we very well could be communicating in 'twenty..1 we just don't know right now got it.

Okay. Thank you.

Thank you. Our next question comes from Mark Breidenbach with Oppenheimer. You May proceed with your question.

Hey, guys.

Got some progress and thanks for taking my question I'm, just wondering aside from the more detailed lung data from the basket study that you've got to present later this year should we be expecting any additional clinical presentations and kind of a second part of the question is do you see any sort of silver lining.

Friedrich Graf Finckenstein: as well as the three non-smallankans accords in the Baskets study allow us to broadly address the remaining needs in non-smallankans. Recruitment also continues in our IOP.

<unk> in the sense that your regulatory filings and your are.

Friedrich Graf Finckenstein: come to a two-basket study of Iovans till and till plus ICI combinations across melanoma, head and neck, and non-smolecular lung cancer. In our C-14504 clinical study in advanced cervical cancer, we continue to recruit a cohort of patients not previously treated with systemic chemotherapy or anti-PD1 to receive Iovans kill plus pambriosis.

Kind of like sinking up with your in house manufacturing capability. So I guess I'm I'm I'm wondering how much of a cogs reduction we can expect.

From manufacturing once you once you translate the bulk of that to run facility. Thanks for taking my questions.

And Mark why don't I take the first part and then I'll ask Igor to answer the second part.

On the first part we're always looking for opportunities to communicate at medical meetings and Theres some coming up at the end of the year, we we haven't guided towards anything specifically there beyond the fact that we would do.

John Mark Delameen: We are also actively enrolling in our Iob-C-L-01 study in CLL and SLL and SLL-P. We hope to be able to provide additional data from these studies at future medical meetings. I will now hand the call over to Jean-Macht to discuss our second cohort of 2021 financial results. Thank you; my comments will reflect the high-level financial results from the second quarter of 2021. Additional details can be found in this afternoon's press release, as well as in the CC-final.

Hope to present more on the core 3 b data in non small cell lung this year, but yes. We are looking we're all trying to you know we're always trying to take advantage of that see in the history of the company we've.

We've you know.

We've made major use of medical meetings wherever we possibly could or possibly could you Gotta do you Wanna do you want answer some questions about the availability of ice T C.

Yes, happy to Hey, Mark Thanks for the question.

So as we mentioned on the call today, we are pleased that the IMD.

<unk> has been accepted by the FDA and we're getting ready to start a clinical manufacturing Oh ICD C facility in Philadelphia Wells are getting ready to support commercial manufacturing.

John Mark Delameen: I will begin with our cash position. As of June 30, 2021, IAvans held $708.7 million in cash, cash equivalents, investments, and restricted cash, compared to $635 million on December 31, 2020. A strong cash position is expected to be sufficient well into 2020 to advance our operating plan, including pipeline development, commercial manufacturing readiness, and lounge preparation. Moving on to the income statement, our net loss for the second quarter ended June 30, 2021 was $81.81.4 million, 53 cents per share, compared to a net loss of $63 million, 47 cents per share, for the second quarter ended June 30, 2020. Net loss for the six months and June 30, 2021 was $156.8 million or $1.04 per share, compared to a net loss of $132.6 million per share for the same period under June 3022.

In 2022 that could support multiple indications in the front.

Thousands of patients commercially and the importance of having a run in house manufacturing is.

There's really 3 fold, we can control over capacity, which in the industry are shorts were in control of all states. We can reduce the cost of goods compared to almost 1 could potentially achieve with contract manufacturing and we believe we can also achieve quite a quality bipolar controlling the facility. So mark I wouldn't be commenting specifically on the Cogs percentages.

But as you can imagine in house facility can allow us to achieve lower cogs than outsourcing.

Thanks, so much.

Okay.

Thank you. Our next question comes from Ben Burnett with Stifel. You May proceed with your question.

Okay. Thank you very much I was wondering if you could.

Just talk about the regulatory strategy for cervical cancer and I guess are we right to assume that the potency assays are rate limiting and should we therefore be thinking about sort of a single BLA covering both indications.

Hi, Ben its free.

The spread I don't know if you want to think about a single BLA, we havent guided to that and that's something that that could go either way, we we've talked a little bit before about this I think the.

<unk>.

Now the potency assay is the gating item for all of our all of our clinical programs all of our Registrational strategy. We think once we resolve the potency assay issue with FDA for melanoma that should allow us to proceed with other clinical programs. However, we have you know we have.

Registrational programs now and we'd have to evaluate exactly how to bring those in front of the FDA. Our first priority above all is getting the potency assay resolved for melanoma.

John Mark Delameen: Research and Development Expenses were $62.1 million for the second quarter under June 13, 2022, an increase of $12.8 million compared to $49.4.4 million for the second quarter and June 18. Research and Development Expenses were $118.1 million for the six months under June 30, 2021, an increase of $11.8 million compared to $106.2 million for the same period under June 30, 2020. The increase in research and development expenses in the second quarter of 2021 over the prior year period was primarily attributable to growth in internal research and development and increasing costs related to manufacturing and our internal ICTC facilities.

Okay understood and then I guess just 1 more question is there a chance that we could see the results of the pivotal like melanoma and cervical studies prior to the BLA submission.

Yeah, well when we when we get close to the BLA submission that would be around the time, where we would typically want to do in IRC read a you know a more formal cut plus the IRC read of the data and so at that point.

John Mark Delameen: The increase in research and development expenditures in the first half of 2021 over the prior year period was primarily attributable to growth in the internal research and development team and costs related to the completion of construction at our ICTC facility, which were partially affected by lower manufacturing and clinical costs following the completion of enrollment in several cohorts of a melanoma and cervical cancer trial. General and administrative expenses were $19.3 million for the second quarter and June 30, 2021, and they increased by $5 million compared to $14.4 million for the second quarter and June 30, 2020.

Net court got cut off sorry, alright, so head and neck right now we haven't we haven't indicated any plans on that right. Now we're always looking for opportunities to do you know medical meetings, where we can present that kind of data. So stay tuned on that the effect sizes and they sort of the details of the assays well. We we're we're still in the in the conversation with MCA about which assay her <expletive>.

As we would use to evaluate potency.

So the you know the the effect or whatever you're measuring in the assay that could vary widely by choice of assay, depending on the detection method, what we actually look at what we used to stimulate stimulation for the method.

So that's still stuff that we would we would work out with F. D. A typically later in the process.

John Mark Delameen: General and annual 35 expenses were $38.9 million for the six months and June 30, 2021, an increase of $10.7 million compared to $28.20 million for the same period under June 30, 22. The increase in general and administrative expenses in the second quarter and first half of 2021, compared to the previous year periods, was primarily attributable to growth of the internal and general and administrative team and higher stock-based compensation expenses. As of June 30, 2021, there were approximately 155 million common shares outstanding.

We've got agreement on an assay, we start to talk about.

The performance of the assay in quantitative terms, including acceptance criteria and I think that's what you're asking about is that right.

Yeah for sure that answered my question. Thanks, so much.

Thank you. Our next question comes from Barnes Speaker with town you May proceed with your question.

[noise] Disneyland is on it please on mute.

Arms.

I offered I can't do anything.

We'll go to our next question from Mirror Goldstein with Mizuho proceed with your question.

Hi, I need to go out from Myra. Thank you for taking the question I have some questions around with the next generation too that was discussed I O V. T C. With your 1 and put you through a line I was wondering about the status.

That and and how should we think about how they are different she had had problems current generations you know when translating into clinic. Thank you.

Sure.

John Mark Delameen: We continue to focus on investment in four key areas as outlined previously to ensure the growth and strengths of value creation, which are advancement and expansion of North Platinum, launch readiness, strong cash position, and a transition from construction to commencement of manufacturing at IC. I remain confident that by managing our investments across these priorities, we will continue to stay focused and align our company with our corporate priorities. I will now end the call back to the operator to kick up the Q&A session.

Operator: Thank you. As a reminder, to ask a question, you'll need to press star 1 on your telephone to withdraw your question and press the pound key. Please limit yourself to one question.

Operator: Please stand by with Compile the Q&A. Our first question comes from Michael Yew, with Jeffries. You may proceed with your question. Hi, guys, thank you.

Michael Jonathan Yee: Congratulations on the progress, and thank you for the question. We had a question about clarifying the next steps on the potency assay. When you say you're going to submit data and meet with the FDA by the end of the year, can you walk through generally what you're focused on submitting, and then when you submit it, do you have to wait a certain number of days to get a meeting, and then you have to wait for the meeting minutes, and then you have to update us, and therefore would that fall into the actual calendar year 2020? Maybe just walk through the chronology of how that works, because that would explain when you'd be able to come back to the street and tell us the next steps.

Indications, where we think we have faster approval routes and then over time, we can develop studies and work with the FAA on study designs that might allow us to.

Economically bring forward the frontline indication.

Frederick G. Vogt: And Michael, Fred, I can answer that for you. It's the FDA interaction process. We're not disclosing the details of what we're doing right now with the FDA, but in general, as you know, there are different types of meetings you can hold with the FDA. They have submission timelines, and then the FDA responds after those timelines, and you host a meeting. For example, for a type A meeting, it's 30 days, for a type B meeting, it's 60 days, you get feedback from the FDA ahead of the meeting, you have the meeting, and then typically 30 days later, you get a written response from the FDA for most of these categories.

Okay. Thanks, and then.

We mentioned 4001.

Just a minute ago.

Can you talk about how that electroporation staff is being integrated into the manufacturing process.

It's occurring and is this being inserted into gen 3 type process or.

Again to just what is that overall timeline look like for 3001, I'm sorry 4001.

Yeah, we haven't disclosed the details of exactly what we're doing in that process, yet and hopefully we can do that at some point at a scientific conference.

So don't assume it's electroporation. However, what we're doing there is a we think it's very similar in terms of timing to gen..2 so we we view Gen..2 is sort of be optimal.

Commercial timing for a product these days with the 'twenty 'twenty 2 approximately 22 day manufacturing cycle. So that this is something we're focused on are what will hopefully provide more detail on for 4001 in a future meeting.

Frederick G. Vogt: We're not disclosing any of the details of exactly what we're doing right now with the FDA, but we are executing on the plan that we described earlier, which is to have these interactions in the second half of 2021, which is what we're in right now. So please stay tuned, and we'll, you know, as soon as we can get some information that we think is, uh, significant and we can communicate, we'll certainly be communicating.

Okay. Thank you.

Thank you. Our next question comes from my Speaker unwanted with 2 of Securities. You May proceed with your question.

Hi, This is bill on for Africa.

It doesn't give them some good anecdotes and insights on going after your discussions for potency assays. For example, you don't require any specific reactivity and also you don't need a new study and really appreciate that but are there any new anecdotes or takeaways that you can share at this time.

Uh huh.

If the FDA were telling you when we have our meetings with with all the analysts and all the Investor community is what we're hearing from FDA as much as we possibly can what they are what they are you just saying directly to us or what they've said in their guidance to industry, especially their celgene potency assay guidance that they put out a about a decade ago now.

Frederick G. Vogt: But to clarify, you would probably not come back to the street on what the result of this stuff is until after you've met with them and all of that, which you're saying is by the end of 21. So if I just do the math on that, that's a calendar 22. Is that a fair conclusion? No, I don't think that's fair.

Which is effectively at the statement on this whole low potency assay sufficient celgene.

Frederick G. Vogt: It very well could be, and our intention is to have the interactions in 21, and we very well could be communicating in 21. We just don't know right now. Okay, thank you. Thank you for our next question. So, Mark Breedenbach, with Oppenheimer, you may proceed with your question.

Free.

I don't have any new anecdotes for you or anything that I can tell you specifically we were all I can say is that we're engaged in.

A lot of discussions with them and we think we can find a reasonable path solution here on the potency assay situation as we've been saying in a.

F D. A you know when you collaborate with them they tend to want to work with you. So we're looking forward to having that collaboration with them in moving the Schwartz.

Thank you I appreciate it.

Mark Alan Breidenbach: Hey, guys, congrats from Progress and then. Thanks for taking the question. Just wondering, aside from the more detailed lung data from the basket study that you guys present later this year, should we be expecting any additional clinical presentations? And kind of a second part of the question is, do you see any sort of silver lining in the sense that your regulatory filings and you're kind of like syncing up with your in-house manufacturing capabilities? I guess I'm wondering how much COGS reduction we can expect from manufacturing once you translate the bulk of that to your own facility. Thanks for taking any questions. I'm Mark Trev.

Thank you. Our next question comes from colleague Tuesday with Baird. You May proceed with your question.

Hi, good afternoon. Thanks, so much for taking our questions.

So obviously work is willing to wait for Gen..3 manufacturing process I guess, how do you.

Seen the manufacturing process, continuing to evolve and get better what could I have a hypothetical adjourn for manufacturing process look like.

Call Me I can give you some thoughts on this I mean, it's it's a little early to say.

How this will play out but you know the idea behind Gen..3 was we're trying to shorten the process more than anything we want to speed. It up we're also trying to lower Cogs.

Yeah.

Make til manufacturing as efficiently as possibly can so that we can we can serve the maximum number of those patients are in the future I don't know exactly what a gen..4 would look like whether it would be shorter or whether it be something more like IV 4000, Walmart where you achieve some some additional feature that has been.

Frederick G. Vogt: Why don't I take the first part, and then I'll ask Igor to answer the second part. On the first part, we're always looking for opportunities to communicate at medical meetings, and there are some coming up at the end of the year. We haven't been guided towards anything specifically there beyond the fact that we do hope to present more on the core 3B data in Montemal Lung this year. But yes, we are looking, we're all trying to, you know, we're always trying to take advantage of that. You've seen the history of the company.

Integrating until manufacturing process, but all of these things are on the table genetic engineering is obviously something that we're very interested in this and.

You can see we you know we've been licensing technology from NIH as we announced recently towards other other.

The modifications that we can make the til therapy.

That sort of thing I don't know if I don't know if that helps answer your question, but it's.

It's something that you know we're heavily invested in and we've already launched the first you know that.

Tend to really did change the game a gen..3 is continuing to change the game. So I do expect we'll have some more innovation here in the future I'm, just not sure exactly where it's going to be right now.

Frederick G. Vogt: We've made major use of medical meetings wherever we possibly could, or possibly could not. Igor, do you want to answer some questions about the availability of ICTC? Yes, happy to. Hey Mark, thanks for asking the question. So, as we mentioned on the call today, we are pleased that the I&D has been accepted by the FDA, and we're getting ready to start clinical manufacturing at our ICD facility in Philadelphia. We're also getting ready for commercial manufacturing in 2022 that could support multiple indications and potentially thousands of patients commercially.

Great. That's helpful. Thank you and for the re treatment arm in the basket study, how long all of it and there will be between.

Till dosing and re dosing and what patients have received any other anti cancer therapy in that window.

So the re treatment in the basket study we don't.

So you mean in L. A you went to a 2 yes sorry.

But Don do you have to happen to have that information and share count.

Yeah, absolutely. So the re treatment strategy is really on a case by case basis. So initially patients that had a response.

Quint progression.

We want the patient stabilized enough that they can do a read the section and that may or may not involve interim therapy before.

Frederick G. Vogt: And the importance of having our own in-house manufacturing is really threefold. We can control our capacity, which in the industry is limited. We're in control of our fate. We can reduce the cost of goods compared to what one could potentially achieve with contract manufacturing. And we believe we can also achieve higher quality by fully controlling the facility. So, Mark, I wouldn't be commenting specifically on the COGS percentages, but as you can imagine, an in-house facility can allow us to achieve lower COGS than outsourcing.

Before they can get ready for the second treatment with.

So thats really its very case by case and depending upon the.

Treatment recommendations.

Great. Thanks for taking my questions.

Okay.

Thank you and I'm not showing any further questions. At this time I would now like to turn the call back over to Fred vote for any further remarks.

Thank you operator, thank you again for joining the <unk> second quarter and first half 2021 financial results Conference call.

Igor P. Bilinsky: Thanks so much. Thank you. Our next question comes from Ben Burnett with Steeful.

Benjamin Jay Burnett: You may proceed with your question. Hey, thank you very much. I was wondering if you could just talk about the regulatory strategy for cervical cancer. And I guess are we right to assume that the potency assays are rate-limiting? Should we therefore be thinking about sort of a single BLA covering both indications? Hi Ben, this is Fred. I don't know if you would want to think about a single BLA. We haven't got guys that at, and that's something that could go either way.

Frederick G. Vogt: We talked a little bit earlier about this. Right now, the potency assay is the gating item for all of our clinical programs, and all of our registrational strategy. We think once we resolve the potency assay issue with FDA in melanoma, that should allow us to proceed with other clinical programs. However, we have, you know, we have multiple registrational programs now, and we have to evaluate exactly how to bring those in front of the FDA. Our first priority, above all, is getting the potency assay resolved in melanoma. Okay, understood. And then I guess just one more question.

[music].

Frederick G. Vogt: Is there a chance that we could see the results of the pivotal, like melanoma and cervical, studies prior to the BLA submission? Yeah, well, when we get close to the BLA submission, that would be around the time where we would typically want to do an IRC read, you know, a more formal cut plus the IRC read of the data. And so at that point, you know, it's fairly typical for companies to disclose something.

Frederick G. Vogt: I can't commit to anything at this point, given where we are in the regulatory process, but you could foresee strategies where we might have that available not long before filing for approval. Okay, that makes sense. Thank you. I appreciate it.

Frederick G. Vogt: Thank you. Our next question comes from Adu Kamar with Goldaq. You may proceed with your question. Thanks, this is Rob on behalf of Madu.

Adu Kamar: Just wondering, do you guys have any plans for updating the Bumcy assays? To what degree are points to address related to the actual assays to use versus the effect size or effect ranges for the current assays? You got cut off partway through there, Rob, a big blank in your question there. Would you mind just repeating the first part of it? Sure, so any updated plans for head and neck data, and then to what degree are the assays related to the actual assay to use versus the effect size of current assays? The head and neck part got cut off, sorry.

Frederick G. Vogt: All right now, we haven't indicated any plans for that right now. We're always looking for opportunities to do medical meetings where we can present that kind of data, so stay tuned. The effect sizes and the sort of details of the assays, well, you know, we're still in the conversation with FDA about which assays we would use to evaluate potency. So the effect or whatever you're measuring in the assay, that could vary widely by choice of assay, depending on the detection method, what we actually look at, and what we use to stimulate as a stimulation for the method.

[music].

Frederick G. Vogt: So that's still stuff that we would work out with FDA typically later in the process. Once we've got agreement on an assay, we start to talk about, you know, performance of the assay in quantitative terms, including acceptance criteria, and I think that's what you're asking about. Is that right?

Frederick G. Vogt: Yeah, for sure. That answers my question. Thanks so much. Thank you. Our next question comes from Borr Speaker with Cowan. You may proceed with your question. If your line is on mute, please unmute, of course. I, operator, I can't hear anything.

Borr Speaker: We'll go to our next question from Mara Goldstein with Missouho. Can you proceed with your question? Hi, hi, this is Abol from Mara.

Mara Goldstein: Thank you for taking the questions. I have questions around the next generation tale that was discussed, I OB3-001 and 4-001. I was wondering about the status of that, and how should we think about how they are differentiated from the current generations when translating into clinic. Thank you. Sure, Ivy 3001 is a monocloma antibody product that's designed to offer an alternative to all death flukein.

Frederick G. Vogt: So don't think of that as a TIL product; it's part of a TIL regimen. I.V.4,000 is, in fact, a TIL product. That's a TIL that has a genetic knockout or silencing of the PD1 gene, that we think will help, we hope will help improve efficacy because it will, The cells will carry a bit of an immunity, if you will, to an inhibitory mechanism in the tumor microenvironment. Okay, thank you. Thank you, and as a reminder, to ask a question, you'll need to press star 1 on your telephone. Our next question comes from Nick Abbott with Wells Fargo. You may proceed with your question. Oh, good afternoon.

Nick Abbott: Thank you for taking my questions. The first one is, you know, and I think I know the answer to the first part, but I have to ask it anyway: when might we see more of the first-line melanoma data? But more importantly, if the data continue to support that scene at ASCO, what are the next steps in the front line, and perhaps more broadly, you know, life cycle management? You could be doing a second-line trial, for example, and then you have a follow-on thing.

Nick Abbott: Yeah, Nick, and the frontline melanoma data that we reported at ASCO, we're always going to be looking for another conference to hopefully update that data and, you know, provide more information about how we're seeing things in that study. Obviously, the data was very promising with the 86% ORR right now and some really, you know, 43% CR rate, very significant numbers in a patient population that in checkpoint only gets 33% response rate with Pembro, with the 6% percent. percent CR rate.

Frederick G. Vogt: So those are things that are really, really interesting to us. We do view the future of TIL therapy as transitioning to front line or early line therapy. However, of course, you know, our focus remains on late-line indications where we think we have faster approval routes, and then, over time, we can develop studies and work with the FDA on study designs that might allow us to economically bring forward the frontline.

Frederick G. Vogt: Okay, thanks. And then, you know, we mentioned 4,001 just a minute ago. Can you talk about how that electro operation step is being integrated into the manufacturing process, where that's occurring, and is this being inserted into a Gen 3 type process or, Gen 2, just what does that overall timeline look like for 2001? I'm sorry, 4,000.

Frederick G. Vogt: Yeah, we haven't disclosed the details of exactly what we're doing in that process yet. Hopefully, we can do that at some point at a scientific conference. So don't assume it's electroporation.

Frederick G. Vogt: However, what we're doing there is, we think, very similar in terms of timing to Gen 2. So we view Gen 2 as sort of the optimal commercial timing for a product these days with an, you know, approximately 22-day manufacturing cycle. So this is something we're focused on. We'll hopefully provide more detail in 4,001 at a future meeting. Okay, thank you. Thank you. Our next question comes from. I speak of Unwarden, with Truist Securities. He may proceed with your questions.

[music].

Asthika Sarith Goonewardene: Hi, this is Bill Ombraffica. You guys have given us some good anecdotes and insights into your FDA discussions for potency assays.

Frederick G. Vogt: for potency assays. For example, you don't require agent-specific reactivity, and you also don't need a new study and really appreciate that.

Frederick G. Vogt: But are there any new anecdotes or takeaways that you can share at this time? Look, FDA, we're telling you when we have our meetings with all the analysts and all the investor community about what we're hearing from FDA as much as we possibly can, what they are, what they're either saying roughly to us or what they've said in their guidance to industry, especially their selling impotency ethic guidance that they put out about a decade ago now, which is effectively the statement on this whole, the whole potency acid situation in Selen I don't have any new anecdotes for you or anything that I can tell you specifically.

Frederick G. Vogt: All I can say is that we're engaged in a lot of discussions with them, and we think we can find a reasonable path to solution here on the potency assay situation. FPA, you know, when you collaborate with them, they tend to want to work with you, so we're looking forward to having that collaboration with them and moving us forward. Thank you.

[music].

Frederick G. Vogt: Thank you. Our next question comes from Colleen Cusie with Bair. You may proceed with your question.

Colleen Margaret Kusy: Thanks so much for taking our questions. So, obviously, work is well under way for Gen 3 manufacturing processes. I guess, how do you see the manufacturing process continuing to evolve and get better? What could a hypothetical Gen 4 manufacturing process look like? Colleen, I can give you some thoughts on this.

Frederick G. Vogt: I mean, it's a little early to say exactly how this will play out, but you know, the idea behind Gen 3 was we're trying to shorten the process. We want to speed it up. We're also trying to lower our colleagues, make pill manufacturing as efficient as possible so that it serves the maximum number of patients in the future. I don't know exactly what a Gen 4 would look like, whether it would be shorter or whether it would be something more like IIVI-4,000-1, where we achieve some additional features that have been integrated into the till manufacturing process, but all these things are on the table. Janic engineering is obviously something that we're very interested in.

Frederick G. Vogt: You can see we, you know, we've been licensed for technology from NIH, as we announced recently, other modifications that we can make to pill therapy and that sort of thing. I don't know if that helps answer your question, but it's something that, you know, we're heavily invested in and we've already launched the first. Gen 2 really did change the game, and Gen 3 is continuing to change the game. So I do expect we'll have some more innovation here in the future. I'm just not sure exactly where it's going to be right now.

Frederick G. Vogt: Great, that's helpful, thank you. And for the retreatment arm and the basket study, how long will the interval be between Tildosing and redosing, and would patients have received any other anti-cancer therapy in that window? For the retreatment in the basket study, we don't. Do you mean an L-U-N-2?

Colleen Margaret Kusy: Yeah, sorry, thank you. Madan, do you happen to have that information? Yeah, absolutely. So the retreatment strategy is really on a case-by-case basis. So initially, patients should have had a response if they had subsequent progression. We definitely want the patient stabilized enough that they can do a re-resection, and that may or may not involve interim therapy before they can get ready for the second treatment with the tip. So that's really, it's very case-by-case and depends upon the P.I.

Yeah.

[music].

Madhu Sudhan Kumar: 's treatment recommendations. Great, thanks for taking our questions. Thank you, and I'm not showing any further questions at this time. I would like to turn the call back over to Fred Boat for any further remarks.

Frederick G. Vogt: Thank you, operator. Thank you again for joining the IAvans second quarter and first half 2021 financial results conference call. I would like to thank our shareholders and covering analysts for the support, as well as our I have aunts employees for their hardworking contribution to developing pill cell therapy for cancer patients. I think it's an exciting time as a company, and we're unwavering on our commitment to advance, and expand the tilt pipeline towards potential approval.

Operator: Please feel free to reach out to our investor relations team if you wish to follow up. Thank you. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Operator: and so on the other, and so on the end up. I don't know.

Operator: I'm gonna be able to be. Thank you, Theeva! and the world.

Operator: I'm gonna. I'm gonna be able to be. And I'm gonna be able to be, and I'm gonna be. I'm gonna be. I'm gonna be on the I'm gonna be Yeah I'm gonna I'm gonna I'm gonna and so on.

Operator: Thank you. Thank you. Thank you. Thank you and so on the same, and so much. Thank you. Thank you. Thank you. And you know, and so on the and Thank you Thee.

Operator: Thank you. Thank you. Thank you. Thank you. Thank you.

Operator: Thank you. Thank you. Thank you. I'm going to be able to be. Thank you. Thank you. Thank you.