Iovance Biotherapeutics Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 9, 2024

There are 16 speakers on the call.

Operator

Welcome to the Ibrance Biotherapeutics Conference Call to discuss First Quarter 2024 Results and Recent Corporate Update. My name is Livia, and I'll be your operator for today's call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session. Please note that this conference is being recorded.

Operator

I will now hand the conference call over to Sarah Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance. Sarah, you may begin.

Speaker 1

Thank you, operator. Good afternoon and thank you for joining this conference call and webcast to discuss our Q1 2024 results and recent corporate updates. Doctor. Fred Zote, our Interim President and Chief Executive Officer, will provide an introduction and summarize key updates on our U. S.

Speaker 1

Commercial launch of MTAGVI and our pipeline program. Jim Zeigler, EVP Commercial will highlight our initial success with the U. S. Commercial launch of mTagV and advanced melanoma. Doctor.

Speaker 1

Igor Walinski, COO, will comment on our commercial manufacturing experience and capacity expansion plans Jean Marc Felomain, CFO, will review our financial results and Doctor. Frederic Finkenstein, Chief Medical Officer, will review key pipeline update including upcoming clinical data presentations at PASCO and new next generation approaches. Doctor. Brian Gaspin, Executive Vice President, Medical Affairs and Doctor. Raj Puri, Executive Vice President, Regulatory Affairs are also on the call and available for the Q and A session.

Speaker 1

Earlier this afternoon, we issued a press release that can be found on our corporate website at iovance.com. 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 and transactions, revenue, commercial activities, clinical trials and results, regulatory approvals and interactions, plans and strategies, research and preclinical activities, potential future applications of our technologies, manufacturing usability, regulatory feedback and guidance, payer interactions, licenses and collaborations, cash position and 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. Our results may differ materially from those projected during today's call. We undertake no obligation to publicly update any forward looking statements.

Speaker 1

With that, I will turn it over to Fred.

Speaker 2

Thank you, Sarah, and good afternoon, everyone. I'm pleased to host our Q1 2024 results conference call. This has been a decisive year for IVANZE following our first FDA approval and a strong start to the U. S. Launch of ANTAGMI for patients with advanced melanoma.

Speaker 2

We expect the positive momentum at Iovance will continue to build throughout 2024 as we ramp up the U. S. Launch and execute across our broad clinical pipeline. To begin, we are very pleased with the high initial demand for AMPEGGY continues to accelerate. Demand has increased month over month since approval and expected to grow further throughout the year.

Speaker 2

As of today, more than 100 patients are already enrolled for AMPACTIV therapy and most are expected to be ready for infusion across the 2nd and early third quarters of 2024. In addition, more than 60 additional patients have been identified at ATCs and are expected to enroll soon. As existing and new ATCs continue to build experience, we expect patient enrollments to steadily increase throughout the year, supporting our expectations for sustained growth. As we anticipated, interest is very high ATCs and they're demonstrating that they have the training, infrastructure and capabilities to treat patients with the MTAGVI, which Jim will further highlight. We remain on track to have 50 total ATCs by the end of this month.

Speaker 2

We also set a new goal of at least 70 ATCs by the end of this year, representing the largest ever number of ATCs for a cell therapy launch. We're pleased to see positive reimbursement trends, which is a key indicator for success and adoption. Positive reimbursement decisions are supported by our clinical data and the recent addition of Aptagney as the preferred second line or subsequent therapy in the National Comprehensive Cancer Network or NCCN guidelines. The time to treatment will accelerate as ATC has established a solid foundation for broad market access and reimbursement, which will add to momentum. Jim will describe this in more detail.

Speaker 2

In terms of commercial manufacturing, we have 2 FDA approved manufacturing sites and sufficient capacity to meet near term demand at launch setting a new bar for cell therapy launches. Our commercial manufacturing experience is very positive and is consistent with our prior clinical experience. We have successfully manufactured and delivered Entagbe within our target turnaround time of 34 days. ATC has observed sufficient availability of manufacturing slots and report a positive experience in the scheduling process, which is critical for broader utilization. We expect to have ample capacity to meet the anticipated ramp up in demand this year.

Speaker 2

Finally, long term expansion is already underway to more than double our currently built capacity for future growth. In addition to the U. S. Launch, are working to enter new markets that can more than double the total addressable advanced melanoma patient population for Eptagbe. Regulatory submissions remain on track this year in the EU, UK and Canada where we have the potential to begin driving significant additional revenue by the end of 2025.

Speaker 2

We also continue to advance and expand our robust and exciting pipeline including 2 registrational programs as well as new next generation approaches that Frederic will highlight on this call. As a fully integrated company is executing a U. S. Launch and developing a broad pipeline, Iovance is well positioned to remain the global leader in innovating, developing and delivering Till cell therapy for patients with cancer. I'll now hand it over to Jim, our Executive Vice President of Commercial, who will speak in more detail about our launch metrics.

Speaker 3

Thank you, Fred. We are excited about the potential for IMTAGV to transform the treatment paradigm in advanced melanoma. My objectives today are to highlight initial U. S. Launch metrics, which are supported by robust demand among ATCs and patients as well as progress with payers.

Speaker 3

ATCs are the key driver of demand in patient enrollments for MCAGNY. Launching with 30 ATCs was a testament to the significant unmet need in advanced melanoma and each center's high level of commitment to offer MTAGV for their patients. Today, there are more than 40 ATCs and we remain on track to meet our goal of 50 total ATCs by the end of May. Due to increasing interest by hospitals that offer MTACV, we are now targeting at least 70 total ATCs by the end of the year. As Fred mentioned earlier, ATCs have enrolled more than 100 patients for MCAGV treatment.

Speaker 3

A patient enrollment is defined as an MCAGV treatment decision by the provider and patient. The patient enrollment is followed by commercial payer, prior authorization and a scheduled tumor procurement for manufacturing. Based on the patient journey timeline and CAGV infusions for currently enrolled patients would likely occur across the Q2 and early Q3. In addition, existing ATCs are screening an increasing number of patients for treatment eligibility. With more than 60 patients currently in screening today, we expect a high conversion of additional patients to a MTAG B patient enrollment in the near term for potential infusion in the Q3.

Speaker 3

We are observing month over month growth and we anticipate sustained growth throughout the year as the number of ATCs expand and there is broader utilization of MTAGV. In the short time since approval, favorable reimbursement trends and medical coverage policies have set us up for success and broad access for patients. Early launch data indicates that more than 75% of patients enrolled for MTAGV are commercially insured, which aligns with our expectations. Thus far, payers responsible for more than 200,000,000 lives have approved at least one patient for ANTEGVI treatment and notably 13 payers responsible for approximately 90,000,000 covered lives have already published medical coverage policies that are consistent with label, clinical trials and the recently updated NCCN guidelines. We expect the remaining payers to issue similar favorable medical coverage policies and that timelines for financial clearance will accelerate as more payers issue coverage policies.

Speaker 3

In summary, we are extremely pleased with the early launch progress and we expect steady growth as ATCs gain treatment experience, our ATC network expands and community referrals increase over time. I look forward to providing future updates on these important ATC reimbursement and performance metrics. I would like to acknowledge the very talented cross functional teamwork at Iovant. I'm even more pleased in the deep partnerships our team has established with ATCs. Collectively, our goal is to broaden and accelerate patient access to ANTEGVI.

Speaker 3

I will now pass the call to Igor Belinsky, our Chief Operating Officer to highlight our manufacturing progress.

Speaker 4

Thank you, Jim. Today, I'd like to highlight our current manufacturing capabilities, experience with the untapped U. S. Launch as well as our capacity expansion plans to support significant further growth and demand that we anticipate in the U. S.

Speaker 4

From geographic expansion and from our exciting clinical pipeline. Manufacturing is a core competency for us at Iovance and we built our own manufacturing facility Iovance Cell Therapy Center or ICTC in Philadelphia. ICTC is one of the largest cell therapy manufacturing facilities in the world and the only one specifically designed for Till manufacturing. ICTC is now FDA approved for commercial manufacturing of Emtekivy for the U. S.

Speaker 4

Market and continues to serve patients in our clinical trials in melanoma lung cancer and other indications in the U. S, Europe, Australia and other geographies. ICTC has been responsible for most of the commercial and tagging manufacturing volume to date. In addition to ICDC, the FDA approved our contract manufacturer site for commercial manufacturing of ONTAGBI. Having 2 approved facilities provides us with additional flexibility and capacity for both commercial and clinical patients.

Speaker 4

Overall, we believe that our manufacturing capabilities and capacity are setting a new bar for cell therapy launches and we're strategically planning ahead anticipated demand in the future. Turning to our early experience with commercial launch, we're executing as planned. The commercial manufacturing experience to date is consistent with prior clinical experience. Turnaround time has been on target with initial launch expectations of approximately 34 days from receipt of tumor tissue to return shipment of untagbe to the ATC, which is then followed by lymphodepletion and infusion. We are confident in our capacity to meet the current and projected demands of the U.

Speaker 4

S. Launch in our clinical trials, as well as to support Iovance's planned future growth. ICTC as built today has the capacity to provide Till therapies for more than 2,000 patients per year. A competent manufacturing team is important in Biotech and cell therapy in particular. Right now, we are staffed appropriately for launch and we are continuing to add headcounts to meet the demand for commercial ONTEGVI as well as for our clinical trials.

Speaker 4

To fulfill our staffing needs, the ICTC Philadelphia location provides access to talent with cell therapy and gene therapy experience at other companies in the region, as well as the next generation of talent through the local schools and resources. In preparation for increasing commercial demand in the U. S. And additional geographies and in support of our advancing clinical pipeline, further capacity expansion is now underway at ICTC and is expected to be completed in a few years. Building out the existing shelf space at the facility is expected to enable ICTC to supply Till therapies for more than 5,000 patients annually.

Speaker 4

Longer term, our vision is to supply Till for over 10,000 patients annually from the ICTC campus. We have an option to construct another building at the ICTC campus and plan to drive additional efficiencies by incorporating increased automation in our manufacturing process. In summary, our team is excited to provide EMTAGBI and our investigational tool therapies for patients with cancer. We are laser focused on the quality of the manufacturing process in the spirit of doing everything right first time at every step from incoming receipt of tumor sample through manufacturing and product release to outbound shipment of Entagbe to the commercial ATCs and investigational tools to clinical trial sites. I'm available to answer additional questions during the Q and A.

Speaker 4

And I will now hand the call over to Jean Marc, our Chief Financial Officer.

Speaker 5

Thank you, Ricard. Today, I will review our current cash position as well as our results for the quarter ended on March 31, 2024. I will also highlight our 2024 outlook. As of March 31, 2024, iovant had cash, cash equivalents, investments and restricted cash of approximately $362,600,000 The current cash position and anticipated revenue from Entire V and Colokings are expected to be sufficient to fund current and planned operation well into the second half of twenty twenty five. Shifting to our Q1 financial results.

Speaker 5

Net loss for the Q1 ended March 31, 2024, was $113,000,000 or $0.42 per share, compared to a net loss of $107,400,000 or $0.50 per share for the Q1 ended March 31, 2023. The net loss for the Q1 of 2024 includes amortization of intangible assets acquired as part of the Proloquim transaction. Revenue for the Q1 ended March 31, 2024 was $715,000 and comprised of sales of pro looking in licensed market outside of the U. S. Cost of sales for the Q1 ended March 31, 2024 was $7,300,000 primarily related to inventoriable costs associated with sales of ProLukin and non cash amortization expense for the acquired intangible asset for developed technology.

Speaker 5

There was no revenue or cost of sales in the Q1 ended March 31, 2023. Research and development expenses were $79,800,000 for the Q1 ended March 31, 2024, a decrease of $2,900,000 compared to $82,700,000 for the same period ended March 31, 2023. The decrease was primarily attributable to the transition to commercial Emtek B manufacturing in the most recent quarter, partially offset by increased costs associated with the purchase of raw materials, clinical trials driven primarily by the Phase III Till then 3 zero one clinical trial and the planned EU regulatory submissions for Lifelossa. Selling, general and administrative expenses were $31,400,000 for the 1st quarter ended March 31, 2024, an increase of $3,300,000 compared to $28,100,000 for the same period ended March 31, 2022. The increase was primarily attributable to increases in headcount and related costs, including stock based compensation to support the growth in the overall business and related corporate infrastructure as well as cost incurred to support the commercialization of Mtagv and ProLumpin partially offset by a decrease in legal costs.

Speaker 5

Regarding our outlook for this year, we continue to guide towards full year 2024 cash burn in the range of $320,000,000 to $340,000,000 excluding one time expenses and we'll continue to leverage opportunities to optimize spending. The U. S. Launch of anthraxbi as well as the sales of Prokukin used in conjunction with the anthraxbi treatment regimen are expected to drive significant revenue in the second half of twenty twenty four and into 2025 beyond. As a reminder, revenue recognition for ONTAGVI occurs upon infusion like other cell therapies.

Speaker 5

So we expect to begin recognizing and reporting significant revenue in the Q2 of this year. For additional information, please see this afternoon's press release and our Form 10 Q to be filed later today. I will now hand the call to Frederic, our Chief Medical Officer to discuss our clinical pipeline.

Speaker 6

Thank you, Jean Marc. I am pleased to speak today about our key clinical pipeline highlights in solid tumors, which as you all know represent more than 90% of all diagnosed cancers in the U. S. One of our key priorities is expanding the label for emtagli to address the need of patients with advanced melanoma in the frontline treatment setting. Our registrational Phase III trial, Tillands 301 is well underway and on track to support accelerated and full approvals of emtaglion in combination with pembrolizumab in frontline advanced melanoma, as well as regular approval of untagbe in post anti PD-one melanoma.

Speaker 6

Global site activation and patient enrollment continue with strong momentum in the U. S, Europe, Australia, Canada and additional countries. Our frontline advanced melanoma strategy is supported by Cohort 1a in our IOV COM202 trial in solid tumors and previously published data on Till therapy in the pre immune checkpoint inhibitor era. We look forward to an oral presentation of updated clinical data from Cohort 18, which continue to strongly support our frontline development plans at the American Society of Clinical Oncology or ASCO Annual Meeting on May 31, 2024. Shifting to our program in non small cell lung cancer, we reported positive updates for our single arm registrational Phase 2 trial, IOV LUN-two zero two in post anti PD-one non small cell lung cancer.

Speaker 6

We resumed enrollment for new patients within a very short time after the U. S. FDA lifted our partial clinical trial hold in the Q1. IOV LUN-two zero two includes clinical sites in the U. S, Canada and Europe with plans to include additional regions with strong track record for enrollment in lung cancer studies over the next few months.

Speaker 6

Enrollment has restarted with high demand, which is driven by encouraging data and further augmented by excitement from the approval of ANXALPI. We expect the registrational cohorts to be fully enrolled in 2025. Current data from IOV, EDU-two zero two and the FDA interactions regarding our regulatory pathway continue to be positive and support our confidence in the opportunity for Till cell therapy in lung cancer. The FDA has provided positive regulatory feedback on the proposed potency matrix for lifileucel in non small cell lung cancer during a recent Type D meeting and has previously announced that the design of the single arm IOV LUN22 trial may be acceptable for approval of lifileucelain post anti PD-one loss small cell lung cancer. In other tumor types, we are starting a Phase II trial of lifileucelain post anti PD-one endometrial cancer, which is a significant opportunity for Till cell therapy.

Speaker 6

Our Phase 2 trial will include patients with advanced endometrial cancer who progressed after platinum based chemotherapy and anti PD-one therapy regardless of mismatch repair status of the tumor. Our rationale is supported by the Till mechanism of action, which may benefit both patient populations as well as preclinical and and no currently approved treatment options for the vast majority of patients with endometrial cancer in the post anti PD-one treatment setting. Given this unmet medical need and the enthusiasm we've received from gynecological oncologists, cell therapy, Iovance is at the forefront of next generation approaches that have the potential to address unmet need for patients and solidify our long term leadership in the space. We reached an important milestone for our genetically modified Till cell therapy, IOV-four thousand and one, in the first in human GM-twelve zero one trial in previously treated advanced melanoma or non small cell lung cancer patients. The Phase 1 safety portion concluded successfully and we are progressing into the multicenter Phase 2 efficacy stage of the trial.

Speaker 6

ILV-four thousand and one utilizes the Talend technology license from Selectus to inactivate PD-one during the Till manufacturing process. We also have options to continue to develop other investigation on gene edited Till cell therapies with multiple knockout targets to potentially improve efficacy. We are also making great strides to advance additional next generation programs towards the clinic. In the Q3 of 2024, we plan to submit an investigational new drug application or IND for a Phase III clinical trial of IOV-three thousand and one, a modified interleukin-two or IL-two fusion protein. At ASCO 2024, a poster will highlight preclinical data that supports the potential for improved safety with robust effector T cell expansion with with inducible and tethered IL-twelve.

Speaker 6

The addition of IL-twelve has augmented Till anti tumor activity in vitro. IV-five thousand and one also builds on the improved efficacy of a prior generation IL-twelve Till therapy that was observed in a clinical trial at the National Cancer Institute or NCI. IOV-five thousand and one is currently an IND enabling studies. We plan to discuss IOV-five thousand and one with the FDA at an INTERACT meeting in the 3rd quarter of 2024 and anticipate an IND submission in early 2025. I'm happy to address questions about these programs and additional trials during the Q and A session.

Speaker 6

I'll now turn the call over to the operator to begin the question and answer session.

Operator

Thank you. Our first question coming from the line of Michael Yee with Jefferies. Your line is open.

Speaker 7

Hey guys, thanks. Congrats on all the progress. We have maybe a 2 part question. You gave some really great metrics around the indications of interest in the enrollment numbers. Can you maybe just describe sort of the journey of time from enrolling and then getting reimbursed and then I think sort of the 34 days to then inbound to get treated?

Speaker 7

I'm just trying to think about how many of the 100 people who've enrolled are likely to get treated and dosed in this quarter and thinking about the consensus number and then thinking about how many of those would get treated in the Q3. Maybe just talk a little bit about the journey and how you think about those 100 patients getting treated? Thank you.

Speaker 2

Yes, Mike. I can give you a little color on that. So the patients right now that are being enrolled right now could be in theory treated in the Q2 or so when I say treated, I mean infused revenue recognized in the Q2 or early in Q3. That's because as we've mentioned, it takes some time to do the financial clearance of the patients as they come in and then they get resected and then there's a target right now which we're meeting of 34 days from the time we start manufacturing all the way through to completing the quality control testing. And then the patient is lymphodepleted and infused after that.

Speaker 2

It's a little different than the clinical trial. The clinical trial rate will move faster because patients weren't on bridging therapy. In many cases now they are on bridging therapy and we have to do it this way and we have the commercial product.

Speaker 7

Okay. So just to be clear, patients have been treated in April and then some of those patients as you are going through it would be treated in May June as part of those 100?

Speaker 2

Correct. In July and so on.

Speaker 7

Okay, got it. Thank you.

Operator

Thank you. One moment for next question. And our next question coming from the line of Andrea Tan with Goldman Sachs. Your line is open.

Speaker 8

Good afternoon. Thanks for taking the question. Maybe a follow-up there. Just wondering if you're able to provide some numbers around those comments. Just of the 100 plus that have been enrolled, how many specifically have had their tumor resected thus far and how many have received an infusion?

Speaker 2

Yes. Hi, Andrew. We can't give you the detail, otherwise you would actually have revenues at that point. But what we can tell you is that right now many of those patients have Impersectin. We're moving through the process with them.

Speaker 2

I want to stress the importance of patients that enroll. Some of them will be infused obviously over that large time period that we just mentioned with Mike's question. We also have a few dropouts in OOS, stuff like that to account for as well. So it's very difficult for us to predict all that stuff. When we finally report revenues, we'll be able to say a little bit more about how that actually played out the transition from enrolled numbers to revenues.

Speaker 8

Got it. And the nature of the dropout, if you're able to share a little bit more there?

Speaker 4

Most of the time the

Speaker 2

dropouts are caused by patient health issues. And sadly some of the patients passed away while they're waiting for therapy and we've actually had that happen. It's an unfortunate consequence of the stage, the disease stage these patients are in. That's usually what the issue is, the patient declines in health and is put on hospice or is passed away before MTAGV can be fully manufactured and tested for them. That's the driver of dropout rate for us.

Speaker 8

Okay. Thank you.

Operator

Thank you. And our next question coming from the line of Peter Lawson with Barclays. Your line is open.

Speaker 9

Great. Thanks so much. Thanks. Thanks for the details. Fred, just maybe you could provide any some more granularity around the 100 plus patients that have enrolled in FITIL therapy, if you could what percentage actually have insurance in place?

Speaker 9

And then the number of ATCs that have actually resected patients? Thank you.

Speaker 3

Hi, Peter. It's Jim Ziegler here. Virtually all of the 100 plus patients have insurance or have cash. So that's not been an issue right now. And by definition, enrolled patient basically means there's the treatment decision followed soon there by commercial payer prior authorization and the scheduled surgery.

Speaker 9

Got you. Thank you. And then the ATCs that have actually resected the patient number?

Speaker 2

Yes. We can't tell you exactly that Peter right now, but it's a substantial number. Let's call it that. It's increasing daily or at least weekly. And it's getting up to the point where hopefully all or almost all of them will overset to the patient in the not too distant future.

Speaker 9

Got you. Final question, you mentioned about cash, what percentage of patients paying in cash?

Speaker 3

We haven't disclosed that.

Speaker 9

Okay. It's a

Speaker 3

low number.

Operator

Thank you. And our next question coming from the line of Tyler Van Buren with TD Cowen. Your line is open.

Speaker 10

Hey, guys. Good afternoon. Congrats on the progress. Shockingly, I have another question regarding the launch. Just regarding the dropouts for enrolled patients that you mentioned, can you discuss what the attrition rate for enrolled patients has looked like so far based upon the dropouts and or manufacturing success?

Speaker 10

And then how that attrition rate might differ for patients that are in screening as we think about the 60 patients you mentioned?

Speaker 2

Yes. Right now, Tyler, it's in line with our expectations. There's been a few dropouts as well as manufacturing aspects, not many. And based on our experience, we feel like it's playing out the way we had expected. We're only going to get better at this.

Speaker 2

The patients that are dropping out sometimes were the ones waiting for a therapy. And obviously that will be less of an issue as we go forward with the launch here. So I can't give you any quantitative numbers on that right now. Obviously, it's very, very early for this, but it's in line with what we anticipated and we're able to handle.

Operator

Thank you. And our next question coming from the line of Yanan Xu with Wells Fargo Securities. Your line is open.

Speaker 11

Great. Thanks for taking our questions and congrats on the progress. Just wondering, for dropouts, Fred, could you comment on whether we could look at maybe perhaps clinical trials experience and historically to get a sense of what might be the percentage of patients who couldn't wait for the duration of the manufacturing and perhaps also insurance approval in this case period? And then wondering about how evenly are the more than 100 enrolled patients are distributed across the 40 plus centers? And lastly, I think I heard a comment Jim made about month over month growth are still expected going forward in the number of enrolled patients.

Speaker 11

Just want to make sure I get the right. And could that if that's correct, could the increase other than driven by obviously increased ATCs, could that still be driven in part by increased number of patients from the already enrolled started ATCs? Thanks.

Speaker 2

Yes, Ian, the comparison between the dropout rate in the clinical trial and commercial is a little bit different. In a clinical trial, we don't have the financial clearance issues. We don't have any of that kind of thing. And the patients are basically being raised through to the therapy. We had as you know, we had a very advanced patient population in the trial late line.

Speaker 2

They were not being bridged and nothing was being done. They had to we could do that because of the trial. So it's a very different experience than treating a patient now where we do have the financial clearance to it takes a little bit of time to resolve, but we've been making progress on that. Obviously, it's going quite well right now for us. But also we're bridging in many cases of bridging those patients and those patients are not necessarily as far along in a treatment journey as they were in the clinical trial.

Speaker 2

So I don't think you compare dropout between the 2. I don't think it's a very good comparison at all. Your second question was how many patients can't wait for treatment. I don't really have a good estimate for you right now on that. That's something we'll have to see.

Speaker 2

But as the launch goes, I think have some indication of what number of patients really couldn't wait because we'll see the dropout rate and we'll understand that. And finally, regarding month over month growth, like Jim mentioned, it could be driven just by the number of patients. So we have centers right now that are enrolling at high capacity and many of the analysts are out there calling those centers and getting information from them and you know all about that. And they're saying things like right now we're enrolling X a month and 6 months from now we'll be rolling X plus 5 a month or X plus 3 a month or whatever it is. So we expect that to be the case across many of our centers.

Speaker 2

Even without the addition of ATCs, we expect the number of patients to go up.

Speaker 11

Those are great color. Could you sorry touch on the second point about how evenly are the currently enrolled patients distributed across the centers?

Speaker 2

We missed that one. Jim, you want

Speaker 3

to get that one? Sure. I can take that. Hi, Jan, it's Jim here. Like other cell therapy launches and in fact oncology launches, most launches don't have even distribution of adoption across the centers.

Speaker 3

And what we will expect over time is all centers will gain experience and increase utilization within each of the centers, but it is not normally distributed for any of the other launches out there.

Speaker 11

Very helpful. Thank you.

Speaker 3

Thanks.

Operator

Thank you. And our next question coming from the line of Colleen Kussi with Baird. Your line is open.

Speaker 8

Good afternoon. Thanks for taking

Speaker 1

our questions. Can you comment on if there's any anecdotal feedback on the experience with IL-two so far and how often that would come up as a potential reason not to pursue a treatment with AMTAGD? And then can you also comment on the profile of the average patient in process right now? I think you mentioned there have been patient deaths in this waiting period. Are you getting a lot later line patients or are you getting some earlier line patients too?

Speaker 1

Thanks.

Speaker 12

Hi, this is Brian Gaston. I'm happy to answer that. We have not seen really any pushback for use of IL-two. In fact, some of the cell therapists who are getting involved in this beyond the medical oncologists who start with the patients have actually commented how IL-two is not a rate limiting issue for them. And even mentioned to me personally how it's self limiting reversible toxicities.

Speaker 12

That is absolutely not been an issue. And I would add that one thing that we've noted was our education to this authorized treatment centers has paid off. The patient selection overall has been pretty good, if I have to say for myself, not knowing what we would have expected. The actual drop off because of progression is rather low. What happens is it's rare enough that it raises an eyebrow, but it's not a very common event at all.

Speaker 12

It's just something that's happened at least once. But it's definitely no more, maybe even less than what we were expecting.

Speaker 1

Great. Thank you. And one follow-up if I can. Just on the you said about 60 patients are in screening right now. What would be kind of common reasons that a patient would fail that screen to not pursue treatment?

Speaker 2

Well, they have to go through the financial clearance. They may not be eligible. They may not be on label effectively. They may not have melanoma in some cases. There can be all sorts of things that can disqualify patients.

Speaker 2

Yes. Through normal medical screening of patients for prescription?

Speaker 3

Yes. Just like the enrolled patients that we currently have, we expect the high conversion because these treating physicians understand the unmet need and are choosing and as much as possible the right patients balancing the unmet need.

Speaker 1

Great. Thanks for taking my questions. Congrats on the progress.

Operator

Thank you. And our next question coming from the line of Asthika Ghanewarjini from Turis. Your line is open.

Speaker 13

Hey, guys. Thanks for taking my questions and also my congrats on the quarter here and the update. I know this question variations of this have been asked, but let me try it this way. Can you up to 100 patients who have been enrolled, can you tell us how many have been resected so far?

Speaker 2

Not yet, Asthika, but there is a very large number that have been resected, I can tell you that.

Speaker 13

Got it. Okay. And then, Fred, when talking about getting financial clearance, can you give us some sort of an idea from enrollment, how many days does it take on average to get financial clearance? I understand it's very early in the launch, but so far what are you seeing?

Speaker 3

It is very early in the launch and it's very consistent with what we've seen with other cell therapy launches prior authorizations take about 3 days and single case agreements vary. It ranges anywhere between 2 to 6 weeks with an average of 3 to 4.

Speaker 13

Got it. Okay. And then lastly, about how many on average vials of IL-two do you anticipate being used per patient? I know it could be up to 18, but what are you seeing so far in the patients that have been dosed?

Speaker 2

I don't have anything new to add there except that I can say in the trial was 6 the average was for the BD and BOS, I think whatever it was, was 16. And I would expect something similar in real practice, but I don't think I would want to quote a statu right now. It's close to 18 though per patient and that's the way it should be.

Speaker 13

Got it. Great. Thanks guys. Thanks for taking the questions.

Operator

Thank you. And our next question coming from the line of Joe Catanzaro with Piper Sandler. Your line is open.

Speaker 10

Hey guys, appreciate you taking my questions here. Maybe similarly, sort of same question in a different vein as we think about the cadence and rate of the 100 patients ultimately being fused. At the end of February, you said there were about 20 patients in progress. We're now about 2 months past that I guess. So can you say or give any sort of additional comments on how many of those 20 patients were ultimately, infused?

Speaker 10

And then my second question is on the early sort of experience or feedback you're seeing on the use of bridging therapy. Are physicians using that and then stopping once they receive on TOGBI and ready to go? Are they sort of receiving the cell shipment and sort of continuing bridging therapy for a prolonged period of time if the patient is benefiting and tolerating that? Thanks.

Speaker 2

Yes, Joe, I can take the first part and then I'll have Brian answer the second part. Of the 20 patients back then that number obviously has become more than 160 today. And I can't tell you exactly how many this point move through. I really don't know, but I would think the vast majority of them move through to actual to at least be in the treatment process. I'm not sure if they've all been infused.

Speaker 2

We don't have that information just yet. But importantly, what we reported is 10 20 on February 28 is now more than 100 and more than 160. So you can see the upswing there is pretty significant. Frank, can you talk a little bit about the bridging? Yes.

Speaker 12

I think it's important to note that we don't have clear line of sight on every patient. The way they get entered into our system, we there's a certain level of assumption that the physician has a background in treating the patient. Where we get the information is when a peer to peer or our response can you repeat that?

Speaker 7

No.

Speaker 12

And when that happens, we get good we

Speaker 2

really get good engagement with

Speaker 12

the sites, the physicians treating the patients. We offer them obviously scientific exchange when needed. And that's where we found out about maybe bridging patients. Interestingly, sometimes the bridging therapy is literally done not because the patient is progressing or can't make it to the therapy, but sometimes the patients themselves want to sort of dictate when the therapy is being given. So bridging therapy really affords a lot of latitude for these physicians, but how often is actually being used, we probably won't know until some real world evidence comes out.

Speaker 10

Okay, great. That's all really helpful. Thanks for taking my questions.

Operator

Thank you. And our next question coming from the line of Reni Benjamin with JMP Securities. Your line is open.

Speaker 14

Hey, guys. Thanks for taking the questions and congratulations on the progress. I guess, I'm kind of curious about whether there's the potential for a backlog at the manufacturing site and how you might handle that. With the number of patients and surgeries that are happening, how do samples kind of wait, I guess, before they're getting processed? How many samples can you handle in a month?

Speaker 14

That'd be my first question. And then second, just switching gears to the Type D meeting you had for non small cell lung cancer. It looks like you got positive feedback on a proposed potency matrix. And I thought we were kind of all done with discussions regarding potency matrix. So I'd love to get some ideas to what's happening there.

Speaker 2

You able to comment on the manufacturing question?

Speaker 4

I can comment on this. Zoran, thanks for the question. It's Igor Belinsky. So right now, as I mentioned, we have sufficient capacity at our manufacturing facility and contract manufacturer for launch. So the capacity is sufficient to meet demand from the commercial omentuvia patients as well as the clinical trial.

Speaker 4

And we actually continue hiring additional staff because we anticipate demand to be growing into the remainder of 'twenty four and beyond. So I think I hope that answers your question the capacity is right now certain adequate for the demand we're seeing.

Speaker 2

And then on the Type C, is Raj available? Raj, can you take that question? We may be a little we may have a breakdown here, Randy, in the audio. I'll take it for you. We have to have regulatory meetings with the FDA for each indication for potency assays right now.

Speaker 2

Now ultimately we may be able to take a platform approach. I'm sure you've seen Peter Marks talking lately about platforms and this kind of thing. But as of today, what we're doing is we're going to the FDA with each of our indications and talking to them about the specifics of the potency assay for that indication. That's what we successfully did recently for non small cell lung, which is a very important step in getting towards a BLA submission for non small cell lung cancer with lifelucil.

Speaker 14

And as we think about timing, Fred, like can we at least assume that since you it took pretty a decent amount of time to get that discussion lead and for everyone to be on the same page. We say that that's kind of 80%, 90% there already with non small cell lung cancer and so things should go by a lot quicker or are we kind of back to the drawing board with each indication?

Speaker 2

No, we're definitely not back to the drawing board. What we're doing now is we're doing it what we think is the right way. We're getting in front of the FDA the right point in our clinical development program for non small cell lung. You can see we're still enrolling for that study. We've got enough data now from enough patients that we can actually show them what we think is a viable potency matrix proposal with data from the actual pivotal patients, which is very important.

Speaker 2

While we're early enough in the study to be able to make adjustments, should they have questions or have things they want to change as opposed to what we did the last time with melanoma was effectively do that all after the fact or largely after the fact if the study was already complete. So what we're doing now we think is the right way to develop polycline T cell therapies and this should actually accelerate our process so that when we finish non small cell lung, we go straight to a pre BLA meeting and straight to a submission.

Speaker 14

Great. Thanks for taking the questions.

Operator

Thank you. And our last questioner coming from the line of Ben Burnett with Stifel. Your line is open.

Speaker 15

Hey, thank you so much. I was wondering if you could maybe just talk about the patient flow within the hospital. Are you seeing any bottlenecks popping up? Like for example, are there any have there been any learnings that have needed to happen sort of efficiently coordinate with the surgeon or anything like that?

Speaker 12

Yes, actually, I would say the opposite. We've really seen a tremendous enthusiasm from the surgeon all the way through the cell therapists and the nurses that treat these patients. We've seen a hospital bend over backwards to operating room time, space in the hospital. We really haven't experienced any of the potential bottlenecking even as we increase. Most of the things that we encounter are really just sort of small questions on details, but not the big issues like having a time or place to treat a patient.

Speaker 12

Okay.

Speaker 15

That's excellent. And if you could also just comment on just the quality of tumor sample coming in for manufacturing, I guess, how is like kind of the specifications around those tumor samples compared to like what you saw in clinical trials?

Speaker 2

I can take that or Igor if you would like.

Speaker 4

I'm happy to. Good question. So far the experience has been very consistent with our clinical experience, including the quality and the size and the quality of the tumor samples for manufacturing.

Speaker 15

Okay, got it. Thank you.

Operator

Thank you. And ladies and gentlemen, that's all the time we have for our Q and A session. I will now turn the call back over to Doctor. Fred Book for any closing remarks.

Speaker 2

Thank you again for joining the Iovance Biotherapeutics Q1 2024 Financial Results and Corporate Update Conference Call. As we've shared on this call, we are very pleased with the strength of the AMPEGBI launch and excited to see accelerated growth throughout the rest of 2024. Thank you to those in the patient, healthcare and advocacy communities, our partners and our exceptional iVance team. I would also like to thank our shareholders and covering analysts for their support. We look forward to presenting data at ASCO and lifileucel in frontline melanoma and we'll host an analyst and investor event on May 31.

Speaker 2

Please feel free to reach out to our Investor Relations team for follow-up. Thank you.

Operator

Ladies and gentlemen, that does conclude our conference call for today. Thank you for your participation. You may now disconnect.

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Key Takeaways

  • Robust U.S. launch: Over 100 advanced melanoma patients have enrolled for lifileucel (MTAGVI) across 40+ authorized treatment centers (ATCs), with plans to expand from 50 ATCs by end-May to at least 70 by year-end and reimbursement policies now covering over 200 million lives.
  • Scalable manufacturing: Two FDA-approved sites (ICTC Philadelphia and a contract manufacturer) deliver lifileucel in ~34 days, currently supporting >2,000 patients/year with expansions underway to supply >5,000 patients and a longer-term >10,000 annual capacity.
  • Financial runway: Q1 net loss of $113 million reflects ongoing investments; $362.6 million in cash and equivalents is expected to fund operations into H2 2025, with full-year cash burn guided at $320–340 million and revenue recognition beginning in Q2 upon patient infusions.
  • Frontline melanoma registrational trial: The Phase III TIL 301 study of lifileucel plus pembrolizumab in frontline advanced melanoma remains on track with global site activation, and Cohort 1a data will be presented at ASCO on May 31 to support accelerated approval.
  • Broad pipeline progression: Enrollment has resumed in the Phase II IOV-LUN-202 trial for post–anti–PD-1 non-small cell lung cancer, a new Phase II trial in post–anti–PD-1 endometrial cancer is starting, and next-generation TIL therapies (IOV-4001, IOV-3001, IOV-5001) are advancing toward Phase II or IND submissions.
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Earnings Conference Call
Iovance Biotherapeutics Q1 2024
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