Iovance Biotherapeutics Q3 2023 Earnings Call Transcript

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Provided by Quartr
November 7, 2023

There are 15 speakers on the call.

Operator

My name is Abigail, 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. Please note that this conference is being recorded. I will now turn the call over to Sarah Pellegrino, Senior Vice President, Investor Relations and Corporate Communications at Iovance.

Operator

Sarah, you may begin.

Speaker 1

Thank you, operator. Good afternoon and thank you for joining us. Speaking on today's call, we have Doctor. Fred Vogt, Our Interim President and Chief Executive Officer Doctor. Igor Balinski, our Chief Operating Officer Jim Ziegler, Executive Vice President, Commercial Doctor.

Speaker 1

Frederic Fingenstein, our Chief Medical Officer and Jean Marc Bellivan, our Chief Financial Officer. Doctor. Brian Gasman, Executive Vice President, Medical Affairs and Doctor. Raj Puri, our Executive Vice President, Regulatory Strategy and Translational Medicine are available for the Q and A session. This afternoon, we issued a press release can be found on our corporate website at iovance.com, which includes the financial results for the 3 9 months ended on September 30, 2023 as well as recent corporate updates.

Speaker 1

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, pre commercial activities, clinical trials and results, regulatory interactions, plans and strategies, Research and preclinical activities, potential future applications of our technologies, manufacturing capabilities, regulatory feedback and guidance, payer interactions, licenses and collaboration, 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. With that, I will turn the call over to Fred.

Speaker 2

Thank you, Sarah, and good afternoon, everyone. I'm pleased to highlight several recent important milestones for IVANCE. We continue to make significant progress toward US commercialization, while pursuing opportunities for our Till therapies in additional geographies and solid tumor cancers. Our top priority is to FDA approval on launch Lifoluso in the U. S, a new class of treatment for advanced melanoma patients with limited options.

Speaker 2

Overall, the BLA process continues under priority review with several positive status updates. We remain engaged with the FDA to complete the review as efficiently as possible. As a reminder, the FDA reiterated in September that there are no major review issues and no plans to hold an advisory committee meeting. In addition, all preapproval inspections of all clinical sites and internal and external manufacturing and testing facilities have been successfully completed. The FDA is also engaged and has no concerns with the status of the Tillman-three zero one confirmatory trial, which remains on track to be well underway by the PDUFA date.

Speaker 2

We appreciate the FDA review team's efforts to expedite our meeting review. We are confident in the potential for lifelucil to redefine the treatment paradigm for these patients who have no approved options after current standard of care. With the strength of our clinical data, manufacturing capabilities and commercial readiness efforts, iAdvance is ready to rapidly serve the U. S. Melanoma community immediately following approval, including the potential scenario for approval earlier than the February 24, 2024 Beyond the U.

Speaker 2

S, we plan to submit additional marketing applications for lipolusol in Europe and other geographies. Based on positive feedback for the European Medicines Agency on Cohorts 214 of the C1440 1 clinical trial, We plan to submit a marketing authorization application in the first half of twenty twenty four with a potential European launch in 2025. We're also engaged with regulatory authorities in the United Kingdom and Canada. We plan to submit marketing applications in both countries in the second half of next year, again with potential launches in 2025. Key markets such as Germany, France and the UK have mechanisms for early access and reimbursement It can begin to drive significant additional near term revenue by the end of 2025.

Speaker 2

Next year, we expect to have additional regulatory updates about our expansion plans for lifelucil in Australia and other countries with a significant number of advanced melanoma patients. Collectively, the advanced melanoma population in Germany, France, the UK and Canada is slightly larger than the U. S. Patient population with the same unmet medical need. Our geographic expansion when complete can more than double the total addressable patient population for lifileucel and advanced melanoma.

Speaker 2

We plan to leverage existing resources to serve the melanoma community in these new geographies without incurring significant additional expenses. For example, our Iovance Cell Therapy Center or ICTC has sufficient capacity for these new countries and we already have an existing office in Amsterdam and field medical As we prepare to launch Lifelucil, we are also integrating Proleukin, a currently marketed IL-two product used as part of the Till therapy regimen. By owning Kralucan, we can offer it alongside Lifoleucil and have full control of the IL-two supply chain. We also expect to lower clinical trial expenses and future cost of goods for Lifoleucil. Beyond our regulatory commercial readiness activities, our robust Till therapy pipeline continues to advance with 7 active clinical trials.

Speaker 2

These include 2 registrational trials, TOVANCE-three zero one in frontline melanoma and LUN-two zero two in previously treated advanced lung cancer, which Frederic will highlight in a moment. Completing enrollment in ON-two zero two in 2024 is a top priority towards a potential supplemental BLA filing. Additional clinical trials include the IOV COM202 trial in solid tumors and our 1st in human trial of our genetically modified cell therapy, IOV-four thousand and one. Lastly, we are excited to introduce a new IVANZE cell therapy program in endometrial cancer. Checkpoint inhibitors are moving into earlier lines of therapy leaving an unmet medical need for patients on or after immunotherapy and chemotherapy.

Speaker 2

Frederick will provide more details on this new program later in this call. Turning to our organization, we have more than 500 people with experience in developing and commercializing oncology and cell and gene therapy products. They are ready for our initial U. S. Launch, ex U.

Speaker 2

S. Expansion and ongoing pipeline developments. We have recently completed headcount growth Onetime investments in commercial manufacturing readiness activities to prepare for launch and expand our pipeline. Following these onetime investments while continuing all key clinical programs and internal manufacturing capabilities. In addition, our September 30 cash position of roughly $428,000,000 It's expected to fund our operating plan into 2025.

Speaker 2

Jean Marc will provide additional color on expense guidance and cash runway assumptions on today's call. We're excited about the near term future at Iovance as we advance and broaden our mission to be the global leader in innovating, developing and delivering Till Therapies for people with cancer across multiple solid tumors. I look forward to addressing your questions later in this call. I will now ask Hubert to present our manufacturing updates.

Speaker 3

Thank you, Fred. We are committed to operational excellence and to date have provided Till therapy to more than 600 patients with a consistent manufacturing success rate of more than 90%. As part of the BLA review process, The FDA completed successful pre license inspections of our Iovance Cell Therapy Center Facility or ICTC and our contract manufacturer's facility. Both sites are prepared with sufficient capacity and staffing to supply our commercial launch and clinical trials. Our manufacturing network strategy supports our vision to establish Till therapy as the next paradigm shifting class of cancer therapy in the U.

Speaker 3

S. And beyond. The ICDC is currently built to supply Till products for more than 2,000 patients annually in the U. S. And our planned geographic expansion.

Speaker 3

By building out additional existing shelf space, ICDC may ultimately supply 2 products for more than 5,000 patients annually. Longer term, our vision is to build capacity for more than 10,000 patients annually by adding new facilities as well as streamlining and automating manufacturing processes. Intellectual Property OR IT is also a critical component at Iovance. We currently own at least 60 granted or allowed U. S.

Speaker 3

And international patents, including Gen 2 patent rights that we expect to provide exclusivity into 2,038. Extensive detail on Iovance owned IP is available on our corporate website and within our Annual Report on Form 10 ks. I would now like to hand the call to Jim Ziegler to highlight our commercial launch preparations. Jim?

Speaker 4

Thank you, Igor. At Iovance, we have the potential to transform the practice of medicine in advanced melanoma and additional solid tumors. In the U. S, approximately 8,000 people die of melanoma annually and the World Health Organization reports higher mortality in Europe. Lifoleucel has the potential to be standard of care for patients who have no currently approved treatment options after standard of care frontline therapy.

Speaker 4

We have a sense of urgency to deliver lifileucel to these advanced melanoma patients upon approval. Our commercial and cross functional teams are on track as we approach our PDUFA date. Today, I will highlight Onboarding for our authorized treatment centers or ATCs, payer engagement and commercial operational readiness activities. 1st, onboarding is a strong indication of ATC commitment and lifileucel demand. Today's press release provided our first status On ATC on boarding.

Speaker 4

Approximately 30 centers have completed pre approval on boarding steps to establish their Till service line capabilities. These centers are educated in all aspects of the lipo leucil treatment regimen with staff and processes to begin Based on our onboarding progress, we now expect to onboard approximately 50 centers within 90 days of the PDUFA date. We are also planning a disciplined approach to organize and schedule each ATC for their first treatments with full Iovance support. We believe a positive initial experience will drive long term success and peak revenues. Reimbursement is also essential for patient Our market access team continues to engage the key national and regional payers to accelerate timely access and appropriate reimbursement for lifileucel upon approval.

Speaker 4

We believe payers appreciate the high unmet need, lack of treatment options and clinical value of lipoleucil in advanced melanoma. We expect strong reimbursement for lipoleucil With the payer mix that includes a favorable commercially insured population, more than 3 quarters of advanced melanoma patients are currently insured through We expect coverage similar to CAR Ts requiring prior authorization with coverage consistent with label, Medical coverage policies issued within about 90 days to 180 days and single case agreements for commercially insured patients. Although pricing will be disclosed after approval, we believe the lifoleucil value proposition supports pricing in the higher range of CAR T cell therapies. The CAR T prices range from $424,000 to $508,000 based on current and reported price increases with additional price increases expected in early 2024. In addition to lifoleucil, we will receive incremental revenue from the sales of Proleukin for each patient.

Speaker 4

As a reminder, Revenue recognition for lipoleucil occurs upon infusion like other cell therapies. As we approach the U. S. Launch, I would like to highlight the extensive cross functional launch preparations underway. Our commercial and cross functional teams are on track as we approach our PDUFA date and we remain confident in our ability to deliver a successful launch.

Speaker 4

I will now pass the call to Friedrich Finckenstein, Our Chief Medical Officer to highlight our clinical progress.

Speaker 5

Thank you, Jim. This afternoon's press release highlighted several pipeline updates. On the call today, I would like to focus on our recent data presentations, are available on our corporate website as well as selected registrational programs in frontline advanced melanoma and non small cell lung cancer. I will also discuss our new Till program in endometrial cancer. We are pleased that Several recent posters and presentations from our C1440 1 trial continue to support the potential benefit of lifileucel as a one time treatment that is differentiated from other immunotherapies for advanced melanoma.

Speaker 5

In October, during the European Society For Medical Oncology or ESMO Congress And at this week's Society For Melanoma Research or SMR, we highlight clinically meaningful and durable During the Society of the Immunotherapy of Cancer or SATC Annual Meeting last week, we highlighted the durable efficacy Shown in our 4 year analysis of cohorts 2 and 4 of the CE-one hundred and forty four-one trial, our poster reported the longest follow-up data on lipoelucel treatment outcomes in the largest population of patients with anti PD-one refractory advanced melanoma treated with Till therapy. Our registrational trials continue to advance an additional indication. Tillvanse-three zero one is designed to accelerated and full approvals of lipoleucel in combination with pembrolizumab in frontline advanced melanoma. This randomized trial remains on track to be well underway at the time of potential approval and is designed as the confirmatory trial We support full approval for leucolefel in post anti PD-one advanced melanoma. We continue to randomize patients and activate global sites in in key geographies with the large presence of melanoma patients and the potential for strong enrollment.

Speaker 5

We recently activated new sites in the U. S. And the first site in Australia. We also have regulatory clearances to open sites in the United Kingdom and Canada. In non small cell lung cancer, we have also made significant progress with our registrational strategy.

Speaker 5

IOV LUN-two zero two is our registrational single arm Phase 2 trial in post anti PD-one lung cancer. Following the positive preliminary data analysis from LUN-two zero two, physician interest and momentum for center participation is strong and remain actively activated with the sites. We also have FDA regulatory feedback that the trial design may be for an accelerated approval of Till therapy and post anti PD-one non small cell lung cancer. The preliminary analysis Included data from the registrational population in cohorts 1 and 2, which enroll EGFR ROS or ALK mutation negative patients We have progressed on or after chemotherapy and anti PD-one therapy. 6 patients had a confirmed objective response, representing an ORR of 26.1%.

Speaker 5

All six responses, including 1 complete response and 5 partial responses, remained ongoing at the time of the data analysis and ranged from 1.4 plus to 9.7 plus months. We remain on track to complete enrollment in LU-two zero two in the second half of twenty twenty four. Based on this trial, we intend to submit a supplemental BLA for U. S. Accelerated approval in post anti PD-one non small cell lung cancer.

Speaker 5

We are proposing a Phase 3 registrational trial in frontline lung cancer, which is intended to serve as the confirmatory trial for full approval in the post anti PD-one setting and to support an approval in frontline treatment setting. We plan to meet with FDA early next year to discuss the The standard of care pembrolizumab maintenance therapy administered after completion of the initial chemoimmunotherapy. Our confidence in this frontline trial design is supported by the encouraging responses and response durations that we have observed with Turning toward our new program in endometrial cancer. As Fred mentioned, we are starting an Iovance pill therapy program in endometrial cancer. The standard of care frontline treatment is shifting And there is a lack of approved treatment options for patients who progress on or after immune checkpoint inhibitor containing treatment regimen.

Speaker 5

Analogous to other tumor types, our one time Till therapy may offer benefit in this setting. Based on the Till mechanism of action, The benefit of Till therapy is likely to extend across patients with tumors that are mismatch repair mechanism deficient and proficient and our clinical program will include patients from both subgroups. We look forward to providing more details as we work towards For now, I will hand the call over to Jean Marc to discuss our year to date 2023 financial results.

Speaker 6

Thank you, Frederic. I will summarize the high level financial results for the 3 9 months ended on September 30, 2023. More details can be found in this afternoon's press release as well as in our SEC filings. Beginning with the balance sheet, iovance had $427,800,000 in cash, cash equivalents, investment and restricted cash as of September 30, 2023, compared to $478,300,000 as of December 31, 2022. The current cash position includes approximately $203,200,000 in combined net proceeds from our public offering in July 2023 and the at the market equity financing facility.

Speaker 6

We expect our cash position and anticipated 2024 revenue from Life and Lossl and Proloquim to be sufficient to fund current and planned operation into 2025. As Fred described earlier, We continue to internally prioritize and optimize our operation and completed many one time investments. As we carefully manage our operating expenses, we are guiding towards 2024 cash burn in the range of $320,000,000 to $340,000,000 excluding one time expenses and we'll continue to look for opportunities to further streamline spending and drive revenue. Transitioning to financial results, Net loss for the Q3 ended September 30, 2023 was $113,800,000 or $0.46 per share compared to a net loss of $99,600,000 or $0.63 per share for the Q3 ended September 30, 2022. Net loss for the 9 months ended September 30, 2023 was $327,700,000 or $1.44 per share compared to a net loss of $290,600,000 or $1.80 per share from the same period ended September 30, 2022.

Speaker 6

We began recording revenue from product sales following the ProLuking acquisition in May 2023 and anticipate Significant revenue after the launch of Life and Usor. Revenue for the Q3 9 months ended September 30, 2023 was $469,000 $707,000 respectively. There were no revenue for the Q3 9 months ended September 30, 2022. Cost of Sales for the Q3 9 months ended September 30, 2023, sorry, was $4,300,000 and $6,400,000 respectively. The cost of sales includes cost of inventory associated with sales of Pro Luching as well as $4,000,000 $5,900,000 respectively of non cash amortization expenses of the acquired intangible assets DEVELOP Technology in the 3 9 months period ended September 30, 2023.

Speaker 6

There was no cost of revenues for the Q3 9 months ended September 30, 2022. Research and development expenses were $87,500,000 for the Q3 ended September 30, 2023, An increase of $15,000,000 compared to $72,500,000 for the same period ended September 30, 2022. Research and development expenses were $256,600,000 for the 9 months ended September 30, 2023, an increase of $42,400,000 compared to $214,200,000 for the same period ended September 30, 20 The increases in research and development expenses in the Q3 and the 9 months ended September 30, 2023, Over the prior year periods, we're primarily attributable to growth of the internal research and development team as well as higher cost related to facilities and the initiation of new clinical trials, including the Phase 3 Till Dans trial, which were partially offset by a decrease in stock based compensation expense. Selling, general and administrative expenses were $27,000,000 for the Q3 ended September 30, 2023, a decrease of $900,000 compared to $27,900,000 for the same period ended September 30, 2022. Selling, general and administrative expenses were $77,000,000 for the 9 months ended September 30, 2023, The decrease of $600,000 compared to $77,600,000 for the same period ended September 30, 2020.

Speaker 6

The decrease in selling, general and administrative expenses In the Q3 and the 9 months ended September 30, 23 compared to prior year periods was primarily attributable to the decrease in stock based compensation expenses and other costs related to the timing of spend compared to the prior year period, including marketing, advertising and legal costs, partially offset by costs associated with the growth in the overall business. As of September 30, 2023, There were approximately 255,800,000 common share outstanding. Before handing the call back to the operator to kick off the Q and A session, I want to reiterate our 2024 cash burn guidance in the range of $320,000,000 to $340,000,000 excluding one time expenses as we will carefully manage our operating expenses in the coming months and quarters. Operator, we can now start the Q and A session.

Operator

Thank you. At this time, we'll conduct a question and answer session. From Peter Lawson with Barclays. Your line is open.

Speaker 7

Great. Thank you so much. Thanks for taking my questions. Just as we think about A potential EU filing, if you can talk about the impact of a single arm study on a EU approval and if that kind of changes Where you think about reimbursement as well in the EU? And then I've got a follow-up.

Speaker 7

Thank you.

Speaker 2

Sure, Peter. Yes, you're thinking of the CAR T products and what they did to get approval there. And obviously, we have the Tillman-three zero one study already running, which could provide us that randomized controlled trial that we could use to and we'll read out right around the time potentially where we could use it to drive reimbursement in Europe. So yes, that's correct. We think as you know there's early access programs in all the major countries.

Speaker 2

The single arm data should be good enough for that. It may seem to find the single arm data and then you get through the early access program and then TILVAN is reading out and potentially you're on to more Longer Term Public Reimbursement Programs in

Speaker 7

Europe. Great. Thank you. And then And I had a follow-up just around the number of authorized treatment centers that Seemed to increase. I'm just curious about what drove that increase, whether it's kind of demand driven essentially or if it was the benefit of the FDA delay?

Speaker 2

Jim, do you want to take this?

Speaker 4

Hi, Peter, it's Jim. Yes, it's a combination of both. There is a high sense of urgency and demand from our treatment centers. So we've had a few extra weeks, months to prepare and we're just Increasing the number, we're very confident to share that number publicly because the demand is so high right now for these centers be able to offer lipolusil.

Speaker 7

Great. Thank you. I'll get back into the queue.

Operator

One moment for our next question. Our next question comes from Colleen Cusi with Baird. Your line is open.

Speaker 1

Hi, good afternoon. Can you hear me okay? Hello? Can you hear me okay?

Speaker 2

Colleen, we can hear you.

Speaker 1

Okay, great. So thanks for taking the question. Congrats on all the progress and on the launch prep. So, clarifying question, on the 30 centers who have completed the ATC preparation, theoretically, if lipoelucel were approved today, could those centers Start preparing to dose a patient today or kind of what else needs to be done for those patients to start using lipocele once it's approved, once they're through the training?

Speaker 2

Yes. Jim can answer this in more detail, Colleen. But yes, basically these guys are ready to go. Jim, do you want to give a little bit more detail here?

Speaker 4

Sure. Thanks, Colleen. Just real quickly, what we've done to date on the pre approval on boarding is, we worked with the centers to develop their service line, which includes the clinical end to end education and training with med onc surgeons, cell therapy. We've operationalized the tumor journey in terms of building out workflows, SOPs, coordination and procedures on All of the logistics from OR, chain of identity, chain of custody to product handling and logistics, And we've worked extensively on the reimbursement front. So when we say that these centers are ready to go, they're ready to go.

Speaker 4

The last step in all of this will be for us to use the final label, make sure that all of our training And initiatives are consistent with label and then we'll roll out a very abbreviated update Based upon the label and centers will be ready to enroll their first patients.

Speaker 1

Great. That's really helpful. Thank you. And you had some commentary around the size and the mortality rates of the ex U. S.

Speaker 1

Territories. Can you just talk a little bit more about the differences in therapy market as you see it in Europe versus the U. S. And talk about what the manufacturing plans will be in those regions?

Speaker 2

Sure. The manufacturing plan we mentioned earlier, we're going to use our ICT facility there. So I want to make it absolutely clear, we're not talking about building a new facility there right now. We're focused on using our existing facility that's already built out, make efficient use for our capital. The CAR T launches in Europe provide a pretty good yardstick for what's available there and what can be done in Europe.

Speaker 2

You can see from there 6 CAR T products have been approved in Europe at this point in different jurisdictions and you've seen sales figures you've seen From the European sales of these things that range anywhere from tens of millions up into the low hundreds of millions at this point. So we see this as a pretty good upside opportunity here. Again, it increases the market significantly. We've got more than 3,000 patients a year in Germany dying from melanoma right now And equally bad numbers in France, the UK and elsewhere. And then we've also got Canada in play here and we're going to look at Australia as well as we've mentioned too where Well over 1,000 patients here dying in Australia of melanoma.

Speaker 2

The demand for Till therapy in these jurisdictions is very high. We have clinical sites there. We know the physicians very well and we're very comfortable with launching the product there. We think it can be successful just like the Cartesare.

Speaker 1

Great. Thanks for taking our questions.

Operator

One moment for our next question. Our next question comes from Yanan Xu with Wells Fargo. Your line is open.

Speaker 8

Great. Thanks for taking our questions. Could you give us a sense of how the review is going? Have you had the late cycle meeting? Have you had any labeling discussion?

Speaker 8

And Also, could you talk about your perception of the agency's resource allocate the resources allocated to the review and whether the previous And then I have a follow-up. Thanks.

Speaker 2

Raj, would you like to take Jan's question? I think Raj is on the line.

Speaker 9

Yes. No, I'll take that question. Thank you, Jan, and thank you for the question. The review is coming along very well. We have been getting IRs and providing all the responses to the agency.

Speaker 9

Our late cycle meeting is planned. We will announce when that has happened. There are no other additional issues Currently, the resource issues seem to be have been under control and we are expecting that our BLA would be approved perhaps before the PDUFA date in January, sometimes in January. The PDUFA date is February 2024.

Speaker 8

Great. And could you elaborate on The estimate of January, is there anything for us to further understand here?

Speaker 9

Yes. So the FDA likes to approve products with the unmet medical need At least 4 to 6 weeks prior to PDUFA date as they have done with all CAR T cell products and other products as well. So with that, keeping that in mind, FDA will like to They like to approve the product sooner before the PDUFA date. So we are expecting the same for the Lifelucid.

Speaker 8

Got it. That's very, very helpful. And then my follow-up is about the number of centers and manufacturing capacity. So great to hear that you have 30 centers virtually ready to go. And by the time of Approval, I assume you might have additional centers ready to go.

Speaker 8

And the question is, would you have Any capacity limit that you might place a cap on the number of manufacturing slots At each of these early centers? And my other question is whether you can foresee That you might onboard more than 50 by the time by 90 days after the approval and would your capacity allow that? Thank you.

Speaker 2

Yes, Jon, let me start and then maybe Igor can help out here. Yes, obviously you're aware of our facility. It's a very large facility. It's got Capacity is built today for the 2,000 plus patients. FDA is the final decider of capacity With cell typical polygon cell therapy, so we can't really say what's going on until we got the feedback from FDA as part of the approval process.

Speaker 2

At the very end, we'll find out more about that. We did announce as you saw that we anticipate 50 EATCs within 9 days of zulfatate. It's possible we can go beyond that. We have to see. Right now that's Pretty large launch.

Speaker 2

It'd be the largest launch ever for cell therapy. So it's pretty aggressive. But let me turn it over to you for just Some comments on the capacity and our ability to scale up between our own facility as well as our contract manufacturer.

Speaker 3

Yes. Thanks, Fred, Jan, and thanks for the question. So first of all, as I mentioned earlier, the FDA completed pre license inspections at both Our ICTC facility and contract manufacturing facility both went very, very well. And so both were successful. So both sites, our ICDC site and the contract manufacturer site are preparing for the launch and also producing clinical material.

Speaker 3

The exact capacity, as Fred mentioned, will be determined by what Capacity of the FDA allows. We've been hiring and training the personnel at what we have been and our Manufacturing partner has been as well in preparation for launch. But again, the exact capacity of launch, we'll know Hopefully in the next several weeks as we get to approval.

Speaker 8

Great, super helpful. Thank you for all the color.

Operator

One moment for our next question. Our next question comes from Michael Yee with Jefferies. Your line is open.

Speaker 10

Hi, thanks for the question. This is Dina on for Mike. Congrats on all the progress. I just wanted to ask about lung. I know that there was a previous disclosure about potentially seeing some second line updated lung data Maybe in a medical conference that's coming up by year end.

Speaker 10

Is that still on track or what are you guys thinking about the lung strategy? Thank you.

Speaker 2

Yes, Dan, we're looking to put data out on lung when we think we have meaningful additional numbers available. So we would really like to see more patients, I think, in the study and then we will get that Medical meeting, I don't know if we're going to get it by the end of the year at this point or it could be next year, but it's important to us to have that data be more significant once we have more patients in the study. Remember, we put out data with 23 patients on a 26.1 percent ORR with good signs of durability. So it could use a dose of additional patients here to help bolster Meanwhile, we're just executing on the study right now and running hard to make sure we can complete enrollment in 2024.

Speaker 10

Perfect. Thank you so much.

Operator

A moment for our next question. Our next question comes from Reni Benjamin with JMP Securities. Your line is open.

Speaker 11

Hey, good afternoon guys. Thanks for taking the questions and congratulations on all the progress on a very informative call. A couple of quick ones. You mentioned following a strategic portfolio prioritization. I typically think anytime that's mentioned there have been programs that have been back burnered.

Speaker 11

Are there any programs that have been back burnered? Because you mentioned that there are 7 clinical studies that are still ongoing. And as part of that, can you just Give us an update as to what's happening with the ovarian study or do you think the endometrial one that you're going to start will kind of take that one over?

Speaker 2

Yes, Rainy, I think you're referring to cervical, I think, instead of ovarian, right? And so we don't have an ovarian program at iVince.

Speaker 11

Sorry, yes, cervical. Yes.

Speaker 2

So all those studies continue to run and we actually think we can continue to run these studies in the budget we're on. We say prioritization, we may focus more on enrolling one particular study or putting our efforts on, for example, the AUMENTO 2 study where we need to enroll fast that doesn't mean we're closing the surgical study. The endometrial study when it does hit will hit later and so we don't foresee a near term impact on cash. We could always reevaluate the programs at that point. What we're basically saying though is we're focusing on particular studies that are of high importance like LUN202 until VANCE-three zero one As well as BLA approvals in the ex U.

Speaker 2

S. Filings at this point so we can drive revenues.

Speaker 11

Got it. Okay. Then just switching gears to the ESMO data that Frederic mentioned. As of the latest long term Follow-up, can you talk a little bit, I guess, about the PFS for the pooled cohorts of TUNE 4? What kind of can you just remind us what kind of subsequent therapies these patients got?

Speaker 11

And if I'm remembering right, correct me if I'm wrong, The 26% of patients that are surviving 4 years, right, their overall survival 26% of patients are out 4 years. Does that suggest that patients who have been treated with lifileucel are not in any way detrimentally impacted by any post therapies or is there another way to look at that data?

Speaker 5

Rene, I can take this one. So as you know, collecting data Collecting subsequent data is always something that you have to take with a grain of salt. We haven't put out a Comprehensive summary of what we are seeing in the study. But again, I think what you're seeing in the long term follow-up data It's really the promise that Till cell therapy has 4 patients Treat it with total in a setting where there's really no available care, right? So I don't actually think there's going to be A pattern here in regards to what these patients would be seeing after, we don't certainly don't see any signals for detriment.

Speaker 5

What we think is really fascinating in this data is the fact is the long term durability. The fact that we now have patients who have Completed the study in response, meaning a 5 year follow-up, which equals to cure And that we see late deepening of responses and conversions to complete response, which is Speaking to the mechanism of action of a living drug, that I think is the importance of this data.

Speaker 11

Yes. Fair enough. I guess just one final question regarding the label. Is there Any possibility of like a blue sky sort of scenario for a labeling discussion where you get more than what you want or Really when we're looking at this data, accelerated approval and the like, you think the base case scenario kind of based on the trial results From cohort 2 and cohort 4 is the best that we can hope for.

Speaker 2

Well, actually, let me say something Rajan that you can add in because we didn't answer Jan on this fully either. But on the label front, we get Cohort 4 followed by Cohort 2 plus 4, which is what we think FDA is leaning towards right now based on our conversations, we think that's the home run, The best option, because that allows promotion on the back of both the Cohort 4 data, the pivotal data as well as the 153 patient data set With MDOR not reached, it's a large dataset. It just gives you a lot of different promotional opportunities for the product.

Speaker 11

Raj, I

Speaker 2

can tell you more about sort of the nitty gritty of the details of when the timing for label and that kind

Speaker 3

of discussion comes up if you want.

Speaker 9

Yes. I think some of Fred covered Pretty well. Some of the labeling discussion actually has begun. We have received a few IRs and we have responded to them. So as far as I will be concerned that the labeling has started and we're going to have more discussions regarding that in next couple of weeks or so.

Speaker 11

Perfect, guys. Thanks for taking the questions and good luck.

Operator

One moment for our next question. Our next question comes from Mara Goldstein with Mizuho. Your line is open.

Speaker 12

Great. Thank you so much for taking my question. If I could just return to the Strategic portfolio prioritization as well as the completion of a number of activities. You mentioned that that is likely to reduce the quarterly and annual operating expenses. So I'm wondering if you can provide us with some guidance As to what that is.

Speaker 12

And then on the ATM program, how much capacity is left there?

Speaker 2

Jean Marc, you want to take that?

Speaker 6

Yes, definitely. Thank you, Mao, for the questions. So I'm not going to be really specific, but you can imagine that this year as we were preparing for launch, There was a lot of one time expenses related to manufacturing readiness even on the CapEx and OpEx front, Also ramping up on the commercial, all the activities and medical. So there is a lot of spend that occurred in 2023 That will be considered again one time and not happen next year. So prioritization means also managing investment over time and That's why we're confident about our ability to reduce our spend both quarterly and annually as we announced during the call.

Speaker 6

And on the ATM, yes, on the ATM, we still have Large amount available because we have a €500,000,000 ATM on which we only do partial amount in Q3. All

Operator

right. Thank you

Speaker 12

very much. You're

Speaker 9

welcome.

Operator

One moment for our next question. Our next question comes from Asika Goonewardene with Truist. Your line is open.

Speaker 13

Hi, this is Karina for Asthika. I had a question if

Speaker 1

you could share some color on the manufacturing success rate, whether you had any discussions with the FDA on this and the potential prospects to be tighter in the commercial setting as has been previously seen with other crises? Thank you.

Speaker 2

Igor, do you want to get that?

Speaker 3

I'm sorry, could you repeat the question, please? My audio was broken up.

Speaker 1

So on the manufacturing success rate, whether you had any discussions with the FDA and for the potential for the spec to be tighter in the commercial setting?

Speaker 2

Yes. So as you know, in

Speaker 3

case of CAR T, we've seen that happen, in some cases to an extreme extent. In our case, we've had the manufacturing success rate maintained in the clinic at more than 90% consistently and in the pivotal cohorts it was 94.7%. The final specs will be set very late at approval. So we cannot comment on the final specs right now, but that's certainly been part of the discussions with the agency and part of the information requests that have been ongoing.

Speaker 2

But we don't expect

Speaker 3

I mean, right now, we don't expect anything as anywhere close as draconian as you've seen in some cases of CAR T in terms of tightening the specs.

Operator

One moment for our next question. Our next question comes from Ben Burnett with Stifel. Your line is open.

Speaker 14

Hey, great. Thanks so much. I wanted to go back and ask another question about just the capacity. I understand that the FDA will sort of help define the capacity At launch, just in terms of the number of slots that are available for commercial use. But I guess, can you frame for us Maybe like an upper limit of the capacity that you feel like you can handle now?

Speaker 2

Yes, Ben. The facility right now is actually constructed to go even beyond 2,000 patients The year at our facility and then on top of that we have our CDMO, WuXi that has considerable capacity too. We haven't disclosed example of what that is, but it's quite large It could represent a good portion of our capacity at launch. So that's really the MAX that we've got constructed today without the need for additional capital.

Speaker 14

Okay. That's helpful. And does that include like the personnel required to sort of run that type of capacity at that level?

Speaker 2

Yes, the majority of that personnel is in place and the rest of it can be put in place very quickly. Obviously, we don't just sit the personnel there As a fixed cost, we don't need to, but we are very well skilled in bringing on manufacturing and QC personnel quickly and know how to do that Both, I have Antoinette, our CMO.

Speaker 14

Okay. That's great. And then maybe just one other question. Just, I guess, can you frame for us when One would expect the labeling discussions to start. Would this be something at the late cycle meeting?

Speaker 11

Has it been the

Speaker 14

first ever sort of Just any color you can provide on that?

Speaker 9

Yes. As I mentioned earlier, thanks for asking this question, That labeling discussion has actually begun. We have received a couple of IRs clarifying things in the label. So and it's going to continue until the perhaps earlier approval date. So it's a good news for us that we have Already engaged with the agency delivering discussion.

Speaker 9

Okay.

Speaker 14

That's great. Thanks so much.

Operator

One moment for our next question. Our next question comes from Kelsey Goodwin with Guggenheim. Your line is open.

Speaker 13

Hey, thanks for taking my question. Just Just a couple of quick ones from me. I guess, maybe just on ex U. S, is this still something that you're looking to pursue on your own? And I guess, is there Any appetite to maybe partner or in specific regions or just more broadly ex U.

Speaker 13

S? And then moving on to the endometrial cancer trial, I guess Maybe could you just remind us what kind of the efficacy benchmark is in the post PD-one setting here? Thank you.

Speaker 2

Yes, I can answer the first one, Kelsey, and then Frederic can jump in on the second part on the end of mutual benchmarks. So we're always Looking for opportunities and yes, we would consider things like partnerships, strategic alliances and things like that. But right now, we do have the ability to go into these jurisdictions ourselves as needed We can do that with Noble Capital Investments right now. As we discussed on the earlier part of the call, we don't need to build a facility there. We don't need to We do a whole lot of hiring there.

Speaker 2

We can get in there and generate revenues relatively quickly. Now if it turns out there's a partnership that would be A value to our shareholders, certainly we would consider that in the jurisdiction. But right now, we're looking to do it ourselves as well. And then Frederic, can you answer the endometrial benchmark question?

Speaker 5

Yes, really good question and I love getting a question on the endometrial program. Thank you. So as you know, what we are seeing happening right now with the Chegg Panepiters moving from a second line treatment setting Into frontline, the data on what's being used and efficacy after use of checkpoint inhibitors is really not available. So I think Probably the best benchmark, the best starting point of where you can what you can look at as a Potential benchmark would be data that have been used when pembro and lenvatinib was brought into the 2nd line setting. There the control arm of study KEYNOTE-seven seventy five was investigator's choice to doxorubicin alpaplitaxel monotherapy.

Speaker 5

And those showed an ORR of about 15% median duration of response of 5.7 months In patients with MMR proficient tumors, the results in DMMR patients We're a little lower with ORR of 12% and medium DOR of 4.1 months. So I think that's probably where you can start Given that, we would be exploring populations that have seen both chemo, frontline chemo, which was the prior therapy For patients in this study in KEYNOTE-seven seventy five, but also either concomitant or sequential checkpoint inhibitor therapy, I think it's fair to say that we would beat we would shoot to beat an ORR of about 10% to 15%.

Speaker 1

Okay, great. Thank you so much.

Operator

That concludes the question and answer session. At this time, I would like to turn the Back to Fred Vogt for closing remarks.

Speaker 2

Thank you again for joining the Iovance Biotherapeutics Q3 Financial Results and Corporate Update Conference Call. We've had a productive year to date with the priority review of the BLA, the close of the ProLukin transaction and 4 milestones to lung cancer and delivering on our key regulatory, commercial, manufacturing and pipeline activities. I'm grateful for the patients, physicians and regulators as well as for our employees and cross functional teams who have collaborated on our BLA submission while advancing our mission to be the global leader in Till therapy. I'd also like to thank our shareholders and covering analysts for their support. Please feel free to reach out to our Investor Relations team for follow-up.

Speaker 2

Thank you.

Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

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Key Takeaways

  • Lifileucel BLA remains under priority review with no major issues identified, all inspections completed and the confirmatory TILVANCE-301 trial on track for a potential approval by the February 2024 PDUFA date or earlier.
  • Ex-U.S. expansion includes an EMA MAA submission in H1 2024 (potential 2025 launch), marketing applications in the UK and Canada in H2 2024, and additional filings in Australia and key European markets to more than double the addressable patient population without significant incremental expense.
  • Commercial readiness is advancing with ~30 authorized treatment centers pre-approved and a goal of ~50 within 90 days of approval, alongside robust payer engagement targeting reimbursement levels in line with high-range CAR-T therapies and integrated Proleukin supply.
  • Manufacturing operations have delivered Till therapies to 600+ patients with >90% success rate; the Iovance Cell Therapy Center is built for >2,000 patients annually and scalable to 5,000–10,000 through facility enhancements.
  • As of September 30, 2023, Iovance held $427.8 million in cash, cash equivalents and investments, expected to fund operations into 2025, with 2024 cash burn guidance of $320–340 million (excluding one-time expenses) and initial PROLEUKIN revenues recorded post-acquisition.
A.I. generated. May contain errors.
Earnings Conference Call
Iovance Biotherapeutics Q3 2023
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