Iovance Biotherapeutics Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 8, 2023

There are 17 speakers on the call.

Operator

Welcome to the Iovance Biotherapeutics Second Quarter 2023 Financial Results and Corporate Update Conference Call. My name is Shannon, 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.

Operator

I will now turn the call over to Sarah Pellegrino, Senior Vice President, Investor Relations, Corporate Communications at Iovance. 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 Belinsky, our Chief Operating Officer Jim Ziegler, our Executive Vice President, Commercial Doctor.

Speaker 1

Friedrich Finkenstein, our Chief Medical Officer and Jean Marc Bellomain, our Chief Financial Officer. Doctor. Brian Gassman, 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 that can be found on our corporate website at iovance.com, which includes the financial results for the 3 6 months ended on June 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 am pleased to highlight several important milestones for IVANS During the Q2 of 2023 and more recently, our Biologics License Application or BLA for our lead Till therapy Lifolucil in advanced melanoma was By the U. S. Food and Drug Administration, or FDA, for 6 month priority review and granted a PDUFA date of November 25, 2023. In the acceptance letter, the FDA also informed us that they do not intend to host an advisory committee meeting and that no major review issues were identified.

Speaker 2

Lifoleucil, if approved, will be the 1st cell therapy for treatment of melanoma in addition to the 1st individualized one time T cell therapy for solid tumor cancer. During the priority review process, we have continued to collaborate with the FDA as they review this nucleus of treatment for advanced melanoma patients with limited options. We remain confident in our prospects for approval given the unmet medical need, our strong clinical data and our positive interactions with and feedback from the FDA. As we approach our PDUFA date, we are building capacity and staffing our Iovance Self Therapy Center, or ICTC, to supply our projected demand for lifileucel at launch. In addition, our field teams are proceeding as planned with onboarding and site readiness activities for our authorized treatment centers, or ATCs, to treat the first lifileucel patient I would also like to highlight that we are now a commercial stage company after closing our transaction to acquire Proleukin, I have 2 product used as part of the Till therapy regimen in May.

Speaker 2

We are integrating Perleukin into our organization as we prepare to launch lifileucel so that we can offer 2 important parts of the Till As noted in today's press release, we recognized some revenue for the first time from Proleukin sales and expect to realize more significant revenue with the launch of lifileucel. Owning Perleukin also provides us with full control of the IL-two supply chain and logistics surrounding Till therapy, and we expect lower clinical trial expenses and future cost of goods for lifileucel. Beyond our regulatory and commercial readiness activities for lifileucel, our robust Till therapy pipeline includes 7 active Clinical trials with the potential to strengthen and broaden

Speaker 3

our mission to be the

Speaker 2

global leader in innovating, developing and delivering Till therapies for people with cancer across multiple solid tumors. In frontline melanoma, our confirmatory trial, TILVANCE-three zero one, has begun randomizing patients And we remain poised to be well underway upon a potential approval of Lifileucel later this year. We have also made significant progress across our trials in non Cell Lung Cancer, NSCLC. We recently announced positive clinical and regulatory updates related to IOV LU-one hundred and two, Our registrational single arm Phase 2 trial in post anti PD-one lung cancer. At the upcoming World Congress on Lung Cancer or WCLC in Singapore, We look forward to presenting detailed data from COAR-threea of our IOV COM202 trial in anti PD-one naive lung cancer.

Speaker 2

The cohort 3a data supports our strategy and upcoming trial in frontline lung cancer. This trial in frontline lung cancer can also potentially serve as a confirmatory trial to As we prepare to launch lifileucel, Iovance now has almost 600 employees with I look forward to addressing your questions later during this call, and we'll now ask Igor to present our manufacturing updates.

Speaker 4

Thank you, Fred. It has been a productive first half of the year at ICTC. We are preparing for the commercial launch of lifileucel And building the manufacturing organization to supply lipolusil to patients upon approval, while providing supply for our clinical trials and supporting extended access. We are committed to operational excellence and have provided Till therapy for more than 600 patients to date With a consistent manufacturing success rate of more than 90%. Our capacity and hiring plan remains on track To support our forecasted demand at launch, the ICDC is expected to supply most of the commercial Till therapies upon approval With our contract manufacturers providing further flexibility to ultimately balance capacity and patient demand.

Speaker 4

We look to establish Till as the next paradigm shifting class of cancer therapy and the ICTC is currently built to supply Till products for more than 2,000 patients annually. Additional existing shelf space at ICDC can also be built out to ultimately supply Till products for more than 5,000 patients annually from this facility. 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 IP is also a critical component at Ivant that supports and protects our proprietary manufacturing processes and know how. We currently own at least 60 granted or allowed U.

Speaker 4

S. And international patents, including Gen 2 patent rights We expect to provide exclusivity into 2,030 8. Extensive detail on Iovance owned IP is available on our corporate website And with our Annual Report on Form 10 ks. I would now like to hand the call over to Jim Ziegler to highlight our commercial launch preparations. Jim?

Speaker 5

Thank you, Igor. At Iovance, we are pioneering Till therapy with the potential to transform the practice of medicine in advanced melanoma and additional solid tumors. Our experienced commercial and cross functional teams with deep Cell therapy experience are building the foundation for a strong lipo leucil launch, while integrating ProLukin to offer as a supportive part Commercial launch readiness is on track as we approach our 25 November PDUFA date. Today, I will highlight on boarding for our authorized treatment centers or ATCs, private and public payer engagement And commercial operational readiness activities. First, we are well positioned to achieve our goal to onboard 40 ATCs within the 1st 90 days.

Speaker 5

We are actively working with ATCs to operationalize their Till service line capabilities And to ensure multidisciplinary teams at each center are ready to administer the lipoleucil treatment regimen upon FDA approval. A significant number of ATCs are currently participating in the onboarding process and we believe they are excited about offering kill therapy. This high level of enthusiasm at our ATCs is reflected by significant investments of time and resources to develop their Till service line and to prepare for anticipated demand and capacity needs among advanced melanoma patients. Fed capacity, for example, is assessed during our onboarding process. Our targeted ATCs report sufficient inpatient hospital beds to accommodate and support lifoleucil and other cell therapies.

Speaker 5

We are also piloting our Iovance Cares enrollment, Scheduling and chain of identity and chain of custody capabilities and training curriculum. We are encouraged as ATCs have provided positive feedback on our customer centric Iovance Cares design and build. Turning to market access, our reimbursement strategies are on track Our market access team continues to engage the key national and regional payers Who are responsible for approximately 90% of covered lives. Based on our payer interactions, we expect coverage consistent with label And similar to recent CAR Ts, for Medicare patients, hospitals already have reimbursement established under DRG-eighteen, which provides more appropriate payment immediately upon launch. As we prepare for launch, I want to acknowledge our cross functional teams who are committed to ensure patients can be treated at ATCs and have access to reimbursement for lifileucel upon approval.

Speaker 5

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

Speaker 6

Thank you, Jim. Today, I would like to summarize recent updates With our Till therapy pipeline and next generation technologies. I'll begin with Tillman 301, our registrational trial for in full approval of Lifelodustin combination with pembrolizumab in frontline advanced melanoma. Till then 301 is also designed as confirmatory trial to support full approval of lifileucelain post anti PD-one advanced melanoma. The first patient was randomized in the Q2.

Speaker 6

Until then, 301 remains on track to be well underway at the time of the potential approval of lifileucel later this We also continue to activate global sites in key geographies with a large presence of melanoma patients and the potential for strong enrollment. In North Small Cell Lung Cancer, we have 6 cohorts across 3 Iovance studies to investigate multiple treatment regimens in various This afternoon, I will highlight our IOV LUN-two zero two registrational trial And post anti PD-one non small cell lung cancer patients as well as the anti PD-one naive non small cell lung cancer patient CohBar 3a in our IOV COM202 basket trial. Last month, we reported regulatory and clinical updates for our registrational Phase At a Type B pre Phase 3 meeting, The FDA provided positive regulatory feedback that the design of the single arm Phase 2 IOV LUN-two zero two trial Maybe acceptable for approval of LN-one hundred and forty five Till therapy in post anti PD-one non small cell lung cancer. Cohorts 12 include our registrational population of EGFR, ROS and or ALK mutation negative patients We have progressed on or after chemotherapy and anti PD-one therapy. For patients with actionable genomic mutations other than EGFR rosoralk, We will require at least one line of an FDA approved TALGALIST therapy as indicated.

Speaker 6

Based on the regulatory discussions, We completed the preliminary analysis of the registrational CORTs 1 and 2 in the IOV LE-one thousand two hundred and two trial. We are very pleased with the initial ORR and durability from this analysis. Confirmed ORR by RECIST version 1.1 was 26 All six responses were ongoing at the time of the data analysis, including one complete response and 5 partial responses. The median duration of response or DOR was not reached and the ongoing responses range from 1.4 plus to 9.7 plus months. Looking ahead, we are amending the protocol to enroll a total of approximately 120 patients within Cohorts 12.

Speaker 6

Enrollment is already underway at more than 40 active clinical sites in the U. S, Canada and Europe, and we We expect to fully enroll our registrational cohorts in the second half of twenty twenty four. Based on the FDA feedback, We plan to pursue accelerated approval based on the LUN-two zero two trial. A planned trial in frontline advancement on small cell lung cancer, which we will discuss with FDA later this year is designed to serve as the confirmatory trial. Our strategy in frontline advancement of small cell lung cancer is proceeding in parallel.

Speaker 6

We plan to report detailed data from Cohort 3a of the IOB COM-two 2 zero two trial at the upcoming World Conference for Lung Cancer. CORE 3a is investigating our Till therapy, LM-one hundred and forty five, In combination with pembrolizumab in patients with advanced North Small Cell Line Cancer, who are naive to ICI treatment. We reported positive top line results from Cohort 3a in a corporate update earlier this year. In the press release, confirmed ORR by RECIST 1.1 was 47%, 8 responders out of 17 patients, including 2 ongoing complete responses or CR. Responses were observed regardless of PD L1 status and safety was consistent with other studies of Iovance Till therapies in combination with pembrolizumab.

Speaker 6

We have been very pleased by the response rates and durability observed so far. In the distinct clinical subsets in Cohort 3, ORR was 80% in 5 patients who were treatment naive and 43% in 7 patients who had progressed after chemotherapy. ORR was 58.7 percent when combining the 12 patients in the treatment naive or post chemo EGFR wild type population. These results inform the design and target population of our planned frontline Phase 3 study. In addition, we were encouraged to observe one complete response among the 5 patients with EGFR mutation for the tumors and progression after prior treatment with who typically do not respond to pembrolizumab alone.

Speaker 6

At WCLC, We plan to report durability and additional Cohort 3a data in approximately the same number of patients. The initial results will be published Then an updated data analysis with additional duration of follow-up will be included in the oral presentation on September 11. We are also preparing to meet with FDA this year to discuss the Cohort 3a data and our proposed registration trial for lysodus in front line advanced non small cell lung cancer patients, which is designed to support full approval in front line non small cell lung cancer We will serve as confirmatory trials supporting full approval in post anti PD-one non small cell lung cancer. Our goal To improve frontline known small cell lung cancer therapy by adding to therapy to standard of care pembrolizumab maintenance therapy administered after completion of the initial chemoimmunotherapy. Our confidence in this approach is supported by the encouraging responses and response durations In cervical cancer, enrollment momentum continues in our expanded Cohort 2 in the ongoing C-one hundred and forty five-four trial.

Speaker 6

Based on FDA feedback, this cohort is investigating lifileucel following progression on or after chemotherapy and anti PD-one therapy to support regulatory submissions. We are also excited about our next generation approaches to optimize Till therapy. Several of these programs incorporate genetic modification utilizing the gene editing Talend technology licensed from selectus to inactivate immune Our lead candidate, IOV-four thousand and one, a PD-one inactivated Till therapy The studies in our first in human IOVGM-twelve zero one trial in patients with previously treated advanced melanoma or non small cell lung cancer. Additional candidates using the TALENT technology, which include multiple inactivated immune checkpoint targets are expected to enter clinical development in 2024. I am available during the question and answer session.

Speaker 6

For now, I will hand the call over to Jean Marc to discuss our first half and second quarter 2023 financial results.

Speaker 7

Thank you, Frederic. My comments will summarize the high level financial results for the 3 6 months ended on June 30, 2023. More details can be found in this afternoon's press release as well as in our SEC filings. Iovance had $317,300,000 in cash, cash equivalents, investments And restricted cash as of June 30, 2023, compared to $478,300,000 as of December 31, 2022. Our use of cash during the period included the front consideration To acquire worldwide rights for Proloquim from Clinigen when the transaction closed in May.

Speaker 7

The front payment was fully financed with existing cash on hand of approximately GBP 167,700,000 or approximately US200 $1,000,000 as well as approximately GBP2.4 million Approximately US3.1 million dollars for certain forward looking inventories. We have also continued to strengthen our balance sheet and remain appropriately funded as we head towards potential commercialization of Lifetodolusol later this In July, we raised estimated net proceeds of approximately $161,400,000 from a common stock public offering. We continue to prioritize our investments and effectively manage expenses. Inclusive of the proceeds from the offering, our current cash position is sufficient to fund our commercial launch preparations, Internal manufacturing, clinical pipeline expansion and operating plan until the end of 2024. Transitioning to financial results.

Speaker 7

Net loss for the Q2 ended June 30, 2023, Was $106,000,000 or $0.47 per share compared to a net loss of $99,300,000 or EUR0.63 per share for the Q2 ended June 30, 2022. Net loss for the 6 months ended June 30, 2023 was $213,300,000 or $0.98 per share compared to a net loss of $191,000,000 or $1.21 per share for the same period ended June 30, 2022. Following the completion of the Pro Looking acquisition in May, We recorded revenue for the first time in the Q2 and anticipate significant revenue for ProLukin to begin after the launch of Life also. Revenue for the Q2 6 months ended June 30, 2023, was $200,000 comprised of product sales of Pro Locking. There was no revenue for the Q2 6 months ended June 30, 2022.

Speaker 7

Cost of sales for the Q2 6 months ended June 30, 2023 was $2,100,000 Cost of sales related entirely to Pro Looking, including $1,900,000 of non cash amortization of the acquired intangible assets For developed technology, there was no cost of revenue for the Q2 6 months ended June 30, 2022. Research and development expenses were $85,800,000 for the 2nd quarter ended June 30, 2023, an increase of $12,900,000 compared to $73,400,000 for the same period ended June 30, 2022. Research and development expenses were $169,100,000 For the 6 months ended June 30, 2023, an increase of $27,400,000 compared to $141,700,000 for the same period ended June 30, 2022. The increases in research and development expenses over the prior year periods were primarily attributable to growth of the internal research and development team, Facility related and internal research program costs and the initiation of our Phase 3 Till Vance 301 trial, which were partially offset by a decrease in stock based compensation expense. Selling, general and administrative expenses We are at $21,900,000 for the Q2 ended June 30, 2023, a decrease of $4,400,000 compared to $26,300,000 for the same period ended June 30, 2022.

Speaker 7

Selling and general and administrative expenses were $50,000,000 for the 6 months ended June 30, 2023, An increase of only $300,000 compared to $49,700,000 for the same period ended June 30, 2022. The decrease in selling, general and administrative expenses in the Q2 of 2023 compared to prior year periods Was primarily attributable to the capitalization of expenses associated with the Pro Looking acquisition upon the transaction close. Decrease in other costs are explained by the timing of related spend compared to the prior year period, including marketing, advertising, licensing And insurance costs, partially offset by costs associated with the growth in the overall business. The minor increase in selling, general and administrative expense in the first half of twenty twenty three compared to the prior year period Was primarily attributable to growth of the internal, general and administrative and commercial teams, offset by a decrease in legal fees and other costs. As of June 30, 2023, there were approximately 224,700,000 common shares I will now hand the call back to the operator to kick off the Q and A session.

Operator

Thank you. Our first question comes from the line of Peter Lawson with Barclays. Your line is now open.

Speaker 8

Great. Thank you for taking my questions. Maybe a quick question just around, I guess, Jean Marc, just around the Cash runway. You said kind of into the end of 'twenty four and I thought the prior Guidance was early 25, if that was 1, if I got that right and 2, if there are any changes internally you were thinking through.

Speaker 7

Thank you, Peter. Thanks for the question. Actually, we were guiding before first half of twenty twenty four and With the recent raise of EUR 160,000,000 let's say EUR 162,000,000 net proceeds, we are adding 2 quarters. So that's why we are commenting around MTU at the end of 2024. Of course, this will depend also on the revenue generated by Producting on one side and Life of the Cell on the other side.

Speaker 7

But let's say, we have 2 quarters more than what we indicated before.

Speaker 8

Perfect. Thank you. And then as we think about the upcoming data, world long, Just if you can tell us about the number of patients and in particular I guess the follow-up time That we're seeing the abstract versus the presentation?

Speaker 2

Yes, Peter, that's still embargoed under the Rules until next week, but there'll be I think substantial follow-up in the abstract and even more follow-up with the conference. I think it will be significant

Speaker 8

And is that also the case in the number of patients, not just follow-up time?

Speaker 2

Now it's primarily follow-up time that you're going to see we're not going to see a huge increase in number of patients in this in the abstract or in the presentation.

Speaker 8

Perfect. Thanks so much. I'll jump back into the queue.

Operator

Thank you. Our next question comes from the line of Michael Yee with Jefferies. Your line is now open.

Speaker 9

Hey guys, Thank you for the questions. Congrats on all the progress. We had 2. One was thinking about the anticipated launch, I know you guys are excited about. And I went back to my old Yescarta CAR T numbers and looking at them, two $4,000,000 or so.

Speaker 9

And I was just trying to understand, do you generally anticipate because of easier reimbursement And the codes as well as preparation for all the coverage that you talked about that this should be A strong launch and potentially better than some of the things that they had to deal with on the CAR T side. Maybe just talk to that a little bit, as people think about the launch? And then second question is following up on the lung cancer data. Can you just remind us how to put into context the 47% overall response rate First line, do you want to be similar to chemo combo? Do you want to be better?

Speaker 9

Is it about durability or one time treatment? Can you just kind of put that into context It's already out there for first line and that would help us see the advantages of your therapy. Thank you.

Speaker 2

Yes, Mike. We do think that our launch can be considerably stronger than what we may have seen from the CAR T products. I don't know exactly the product you're referring to. But As a general matter, we've gotten the stars are more aligned for us than they were at the time of the CAR T launches because just A more navigable reimbursement landscape, for example, we've got the Medicare MSCR G18 code already established for lifileucel. We've learned a lot from their experience in terms of capacity planning, site onboarding, how to target individual centers and get them up and running manufacturing So yes, just a general matter, we anticipate a stronger launch.

Speaker 2

If I missed your point there, I can have Jim Follow-up with you on that. On the lung data, I'd be looking as your benchmarks in particular for the Cohort 3a. We're looking at the first two subgroups, Which we call the ICI naive and the chemo refractory subgroups and the comparators for those are the KEYNOTE-four 4.7 KINO-one hundred and eighty nine trials, which showed ORRs in the 48% to 58% range with MDRs in the 7 to 11 months range. So, Beth, you're looking at pill plus pembro plus chemo being superior to that.

Speaker 5

Perfect. Thank you.

Speaker 2

And you quoted by the way, I should add, Mike, you quoted 47% ORR. That's the ORR across all three subgroups. The ORR in the 2 subgroups that are comparable to that is 58.3%, Frederic mentioned that during his comments earlier.

Speaker 9

Got it. Thank you for clarifying that.

Operator

Thank you. Our next question comes from the line of Tyler Van Buren with TD Cowen, your line is now open.

Speaker 1

Hi. I have a question on the So I'm curious what in reference to what the KOL mentioned on the call that you guys recently hosted,

Speaker 10

I'm curious to see what

Speaker 1

you guys exactly are doing to overcome the challenges of under education among the physician community to facilitate more efficient referrals upon launch.

Speaker 2

Yes. For that one, I'll probably ask Jim and Brian to And just give a little bit of summary of what we're doing to work on referral patterns.

Speaker 5

Sure. This is Jim. 60% of the patients are in the community, so referrals are going to be very important for us beyond the initial months of launch. Here what we're doing is taking data driven approaches to understand existing referral patterns as well as building understanding of where these patients are In the community, we'll use personal promotions, I. E, the sales force to go out and talk to the physicians with A high concentration of advanced melanoma patients, and then we'll use cost effective non personal promotions to Expand our reach and frequency to educate on, lipolusol among community practices.

Speaker 1

Okay. Thanks so much.

Operator

Thank you. Our next question comes from the line of Colleen Tucci with Baird. Your line is now open.

Speaker 11

Hi, good afternoon. Thanks for taking our questions and congrats on all the progress. So as we're within now a number of months of expected approval, do you have any sense of pent up demand at this stage? And is there any segmentation of the patient population in the market that you'll prioritize in the early portion of this launch based on baseline patient characteristics or things like of that nature?

Speaker 2

Yes. Let me add a few comments and then Jim can jump in here. We have a pretty good sense of pent up demand. It's We run an expanded access program which gives us some feel for how the demand is out there plus for contact With all the investigators and patient advocacy groups constantly. Jim, do you want to see if you can take the rest of that question?

Speaker 5

Sure. Hi, Colleen. We do a very robust segmentation based upon claims data here in the U. S. Market.

Speaker 5

So on the ATC side, we segmented based upon the volume of patients and we've identified our top 20, 40, 60, etcetera ATCs As well as patients that are concentrated in the community. Because we have studied the CAR T market quite Sensibly, we know that there is a concentration of patients at the top centers. So those are the targets that we're going for first. And as we have those patients enter the treatment paradigm for lipoleucil, we'll start to expand out into the community.

Speaker 11

That's helpful. Thank you. And then any more details you can share on how many centers are participating in the site onboarding process? And can you maybe just share any more details on what that process looks like for centers?

Speaker 5

Sure. I won't be able to share the exact numbers, but I will reinforce our goal is to launch with targeted 40 centers within 3 months of approval, And we are on track. What I will say is that there are more centers that are participating in the onboarding. So I think it It is reflective of the unmet need and the excitement again amongst the ATCs. And I'm sorry, Colleen, can you repeat that second question?

Speaker 12

Just any more details you

Speaker 11

can provide on what that process looks like for centers and how long that might take and how onerous that is?

Speaker 5

Sure. There's some administrative things that we do like IT checks to make sure that the firewalls are compatible for our systems. But the heaviest work is really our medical affairs team, which worked with the centers on their Our capabilities to understand and build workflows, SOPs, make sure that order sets are defined. The whole process, if a center is fully engaged, can be relatively short. If it's a center that's got a lot of competing demands, it could take a bit longer.

Speaker 5

For centers that are entering the process right now, I'm confident that they could, if they are fully committed, be ready for launch.

Speaker 11

That's very helpful. Thanks for taking our questions.

Speaker 5

Thanks, Collin.

Operator

Thank you. Our next question comes from the line of

Speaker 13

I was wondering if you could give some broad strokes Characterization of the ongoing BLA for lefeluzil. In general, how is the process Going, are you at or nearing the mid cycle review stage? Any concerns that might have arisen? And also when might you have a date for pre approval inspections? Thanks.

Speaker 2

Yes. Hi, Shannon. Yes, it's going well right now. You guys said the mid cycle, we're past that period now. Things continue to go well.

Speaker 2

Still no adcom. It seems to be pretty clear with us from the get go that there aren't any major review issues. We won't comment publicly on when pre licensing inspections will But they typically occur later in the process. That's something obviously company like Iovance and our CMOs have to prepare heavily for us. So we're working very hard on that right now.

Speaker 2

But otherwise, it's going very well. The FDA is very engaged. We've got a lot of back and forth. It's very productive and we think the things remain on track for the date of November 25, 2023.

Speaker 13

That's terrific to hear. Thanks for that update. I do have also a couple of questions on the ILU-two zero two and the pivotal program. And I was just wondering any additional color from your interaction with FDA For that setting, what kind of ORR and DOR is the agency looking For a pivotal data set or in other words, what might be the bar for approval and success for that trial? And could you also talk about the powering assumption for this 120 patient study and whether there is any opportunity for interim Thank you.

Speaker 2

Yes, Frederic, do you want to take that one?

Speaker 6

Sure. Yes, thanks. Good questions. So I think one thing that we have to keep in mind is whenever we're talking about single arm data like this one, FDA always stresses that they will look at the totality of the data in oncology study That's oftentimes, because that's the relevant endpoint that you can actually appropriately address with a design like this response rate, But they will also heavily look at duration of response and safety. So there is really no single there's no Single number that FDA will tell you if you beat that then you have yourself a game.

Speaker 6

It's really the totality of the data And they're looking at how what you are presenting when you submit is comparing to available care. Right now, again, Response rates, that means dose attacks or dose attacks on amisirumab might be something that they're looking at where the you have a range of ORRs, but you have Definitely short durability of responses and that's something that they're looking at, which is exactly why we're excited about the data in LUN202 right With the durability looks really promising and safety is obviously an aspect as well. In a study like this With a single arm design, you would usually not do an interim analysis because it's really the final data that gives you the totality of data that It's informative. You wouldn't necessarily stop based on in between REIT with a smaller sample size. Does that answer your question?

Speaker 13

Yes, yes, it does. I was also lastly wondering, Are you in a position to comment whether those patients who had a response and were ongoing as of the Data cutoffs are still in ongoing response. Thanks.

Speaker 6

Yes, I can respond to this. What we shared just a short while ago was very hot So the data set that we disclosed was basically cut just a couple of days prior to when we shared it. So maybe that gives you a good idea on where we stand on that.

Speaker 13

Got it. Thanks for all the answers.

Operator

Thank you. Our next question comes from the line of Reni Benjamin with JMP Securities. Your line is now open.

Speaker 14

Hey, good afternoon guys. Thanks for taking the questions and congrats on the progress. Maybe just starting off, this might be for Jim. You talked about the 40 ATCs. Jim, about how many patients do you figure each, I don't know, ATC could handle in a month or in a quarter?

Speaker 14

I think you mentioned that Bed capacity is sufficient. Can you maybe help quantify what sufficient is according to each of these ATCs and do they vary significantly, for example, the top 20 versus the top 40 versus the top You know, call it 60 or 80. In terms of capacity or are they all right around the same?

Speaker 5

Hi, Rene. Thanks for the question. It's a terrific question. So we've looked at both the CAR T market as well as our own data. What we know is that there is a concentration.

Speaker 5

So the number is going to vary. Your top centers are going to have more patients compared to centers that are beyond 40 to 60, etcetera. And therefore, bed capacity is going to vary to some degree. What I'm not saying is that all hospitals will always have sufficient capacity. But in general, as we've engaged the ATCs, They have reported that they would have sufficient capacity.

Speaker 5

In our corporate slide deck, we provided some numbers, both from HHS in the healthdata.gov, which characterizes hospital capacity overall And then our own internal team, as we've been engaging with these ATCs for a while now, we engage them on the number of beds Often broken down to the various levels, various floors. So when I say that hospitals have sufficient capacity, It's based upon both of these data points.

Speaker 14

Got it. And just sticking with sales and marketing for a second, how big is the sales and marketing team right now? And by the time November 25 comes along, how big will it be?

Speaker 5

Sure. I won't give you a specific number, but we're Probably in the 30 plus range right now. About half of my team members come with previous cell therapy experience, Including nurses and advanced nurse practitioners who've actually joined us from the ATCs themselves, I have a number of very experienced nurses who've actually onboarded and helped to treat patients on CAR T. So I've got a lot of experience on the team. In terms of the onboarding right now, the existing team between commercial and Medical affairs is sufficient to drive the onboarding process.

Speaker 5

So it won't need to hire the actual sales team until We get a little bit closer.

Speaker 14

Got it. Okay. And you guys provided a little bit of a goalpost For the non small cell pivotal study in terms of completing enrollments at the second half of 2024. Can you give us any sort of sense as to how the cervical cancer Trial is going and whether you have an idea as to when enrollment may complete there?

Speaker 2

Now we haven't guided on that study. Obviously, we had to restart that entire program after the approval of Pembrolizumab in frontline setting and other companies had to withdraw their BLAs. So it's going. We Try to leverage the existing sites and it's running, but it's not the type of study where we can project enrollment right now. We're trying to just enroll as fast as we can and now this new patient Populations that are created by the approvals.

Speaker 14

Got it. And just one final one for me. As we think about The next generation TILs, genetically modified TILs. How should we be thinking about it In terms of how those products exist with the what will hopefully be currently approved Till products And how do we think about potential cannibalization or is there a way to position those 2nd generation drugs so that Both can kind of coexist in the same commercial space.

Speaker 2

If you're asking about the 2nd generation and beyond drugs that we're developing based on the Till platform at Iovance, We don't necessarily have to cannibalize our indications. We can develop those other genetically tailored therapies, for example, into different indications, not like we have to There's plenty of solid tumor indications out there that look to be promising that show Some signs of responsiveness to either ICI or TILs are combined, but need additional efficacy to Get over the hurdle and that will be where we're focused and that necessarily not necessarily is the same indications that we will be seeking approval in or getting approval in the near future.

Speaker 14

Perfect. Thanks for taking the questions.

Operator

Thank you. Our next question comes from the line of Ben Burnett With Stifel, your line is now open.

Speaker 10

Hi, good afternoon. This is Carolina Ivanoventoso on for Ben Burnett. Thank you for taking our June, in a scenario where lysilucel gets approved and you treat the uninitial bolus of melanoma patients who have already progressed on And then separately lifileucel is also available in combination with pembro Through the Pilvan trial, how do you think physicians will treat newcomers? Will they treat the new coming patients with a sequence of pembro and then if the patient progresses with lifileucel? Or do you think there will be situations where doctors may want to try to hit the tumor heart from the

Speaker 2

So It's a good question. We will have this Phase 3 study up and running and into clinical trials. So I would we anticipate majority of doctors will be wanting to treat their post PD-one patients On lifileucel commercially approved, which is going to be much more available than what one can get from a clinical trial setting. However, So you could have access to the trial or a more deep have a deeper understanding of how ICIs and TILDS combined might be interested in using the TILVAN study more preferably. And that's why we'll have it open in the United States as well as outside the U.

Speaker 2

S. To drive that involvement.

Speaker 10

Okay, understood. And then a quick clarification Question for Jean Marc. On the guidance, the extension to second half twenty twenty four, Does it include any potential revenues from Proleukin and lifileucel?

Speaker 7

Yes, we are taking into account only pro looking revenue at this stage because of course We cannot although we are very positive about the approval, we don't want to take life of the revenue into account. So it's only product that I take into account in my Okay.

Speaker 10

Makes sense. Thank you so much.

Operator

Thank you. Our next question comes from the line of Asthika Goonewardene with Truist. Your line is now open.

Speaker 3

Hi, guys. Thanks for taking my questions and I'll echo my positive sentiments for the progress we made here. First off, I'd like to direct the question at Fred. Fred, when we spoke last at our Simple GSL conference a couple of months ago, when we discussed centers building You mentioned that some centers were building capacity at about to treat about 25 or more patients a month. So I want to just maybe Check back in with you on this.

Speaker 3

Can you quantify what proportion of these 40 centers that you're targeting in 1st 3 months after approval Gearing up the capacity to treat this number of about 25 patients a month, is it a majority, a significant proportion or a minority? And then I've got a couple of more questions.

Speaker 2

Yes. So that Jim partially answered that question a little bit earlier. There's a slide in our deck, I believe it's Slide 38. It has in it some data that we collected and that's where the 25 number is coming from that I would have mentioned at the conference when you were there. It's basically the number is the average number of beds for target ATC per month suitable for lifelusive patients.

Speaker 2

That's what the number is. So that obviously that's an average and you're going to have a minimum and maximum there and there's a whole series of statistics there, but that's the average. We have the data. We're trying to keep some of the confidential because some of it is confidential at the sites. But the average is about 25 That is for targeting ATC per month for suitable for lipolus patient.

Speaker 2

Like Jim said earlier, there could be some that are lower, there could be some that are higher, the big centers are going to have more. It all comes down to the amount of investment the hospital is making, and it's BMT, CAR T and total service lines.

Speaker 3

Got it. Okay. And then when you stress tested your production facility and gone Full production, about how many bags of cells can you manufacture full capacity?

Speaker 2

We haven't Disclosed how much we can manufacture and what you're calling stress test. We do things called capacity demonstrations As part of what we do to demonstrate to the regulatory authorities that we can manufacture at scale here and what we've done so far is consistent with what we disclosed for the site, Besides both Ivance and our CMO, in terms of the capacity that we're projecting for the market. So if you go to our deck and look at the number of patients we said we can Accommodated our facilities, you can assume that we've got capacity that's within those boundaries or ramping up to those boundaries. We haven't put the exact number out, but that's something that we were focused very much on internally and work with FDA on.

Speaker 3

Got it. Okay. And then I don't know if Raj is available on the call here, but I appreciate there hasn't been a request for an ADCOM, but maybe if Raj can comment, Based on your experience, what would be a scenario that would prompt the FDA to ask for an AdCom?

Speaker 15

Hi, this is Raj. So thanks for the question. I don't expect that FDA will seek any AdCom At this point, based on our as Fred mentioned earlier in the call that we have a frequent interaction with the FDA and It's all it's a routine as a part of the BLA review process. Nothing we have identified our FDA so far I will take you through ad comments. Late in the review cycle, and so I'm not expecting any ad comments at this point.

Speaker 3

Great. I like the confidence there, Raj. And then last one, if I can, to Friedrich. On 4,001, Is there any possibility of an update this year? Apologies if I missed it if you mentioned this earlier, but that's my last question.

Speaker 3

Thanks guys.

Speaker 6

Thanks for the question. We haven't provided guidance on timing on updates on that study. So I think Bear with us. We will once there's something to update on.

Speaker 3

Got it. Thanks so much guys.

Operator

Thank you. Our next question comes from the line of Joe Catanzaro with Piper Sandler. Your line is now open.

Speaker 16

Everybody, thanks for taking my questions. Maybe a couple of follow ups on a couple of things that have been covered. Maybe first on cervical, Does another FDA interaction need to happen there to firm up some things or is the challenge simply around projecting timelines because of enrollment pace? And then second question, just wondering if you could say anything about the progress you've made on Till then 301 and Whether you have expectations that the FDA might ask for a status report of that trial ahead of the November PDUFA? Thanks.

Speaker 16

Yes, I

Speaker 2

can take this. So on cervical, it's more about the size of the patient population. It's not a large patient population than it is about regulatory We've already had a lot of regulatory interactions at the Yale and that

Speaker 4

we feel pretty comfortable where

Speaker 2

we are. That doesn't mean we won't have additional interactions Leading into a potential BLA there, but we need to focus right now on just enrolling. With respect to TILVAN-two zero one, the FDA remains in close Contact with us about that study to make sure it's well underway and we feel quite comfortable with where we are and what we disclose to them. They do ask about that and we have given them updates.

Speaker 16

Okay, great. Thanks for taking my questions.

Operator

Thank you. Our next question comes from the line of Mara Goldstein with Mizuho. Your line is now open.

Speaker 12

Great. Thanks so much. I had a question on LUN-two zero two study and then just a follow-up on PROLUQUIN. On the study you're going to enroll PD L1 patients with scores greater than 1% and less than one Are they pre stratified into set numbers or is it all comer?

Speaker 2

No, it's going to be a total sample size of 120 we're going to across the 2 cohorts.

Speaker 12

Okay. So there's no particular number of one versus the other in that trial?

Speaker 2

No, but we expect it to be relatively evenly balanced.

Speaker 12

Okay. And then can you help us understand a little bit about, Proleukin X obviously commercialization with lifileucel given the revenue that you recognized in the short period of time that you opened relative To the COGS and just how we should think about that on a go forward basis?

Speaker 2

So you're asking Mara, you're asking about ex U. S. Revenues Without lifelucine?

Speaker 12

Yes.

Speaker 2

Yes. So ProLukin outside the United States is priced at relatively modest numbers right now And the sales were not particularly high. So that's not something we look at as a major revenue driver for us. That's what you're asking. Now upon launch of lifileucel that could More significant, but it's still a lot different outside the U.

Speaker 2

S. Than it is in the U. S. Because of the pricing difference.

Speaker 12

Right. But it's still on its own profitable, correct?

Speaker 2

Outside the U. S, is it profitable? I don't know. It's a it can make a you can make a profit on outside the U. S, but it's somewhere nearly what's in the United

Speaker 12

Okay. All right. Thank you.

Operator

Thank you. Our next question comes from the line of Kelsey Goodwin with Guggenheim. Your line is now open.

Speaker 1

Hey, good afternoon. Thanks for taking my

Operator

question. I guess first, could you just remind us maybe of the efficacy bar in cervical cancer kind of given the evolving landscape that you mentioned and especially since the last time we saw a data cut there. And then maybe just to confirm based on your interactions with the FDA, are we still leaning towards the label, including the pooled data of Cohorts 24? And that's it for me. Thank you.

Speaker 2

Yes. Why don't I take the second part and then I'll hand it to Frederic to take the first part. Yes, the FDA has given us favorable feedback The pre BLA meeting on the full data. And so yes, we do continue to think that there is a possibility we can get that on the label, a good possibility that we'll have some indication of full data on the label. That's something we're working towards, obviously.

Speaker 2

Frederic, do you want to take a question about the bar for cervical?

Speaker 6

Sure. The bar is low. Where we are right now, we're basically similar to how we have seen this happen in lung cancer where check has moved into frontline in combination with standard of care chemo. Now the post PD-one and the post Front line setting is wide open again. The data that are available from Times Square folks were then looking at 2nd and third line therapy for cervical cancer with other chemotherapeutics, either as monotherapy or other combinations We're pretty dismal with response rates reported between like between 3% and below 10%.

Speaker 6

The bar is really low and beyond that medical need is high.

Speaker 12

Great. Thank you.

Operator

Thank you. And I'm currently showing no further questions at this time. I'd now like to turn the call back over to Fred Vogt for closing remarks.

Speaker 2

Thank you again for joining the IVANS Biotherapeutics Second Quarter 2023 Financial Results and Corporate Update Conference Call. We've had an exciting start to 2023 with the acceptance of the BLA, the close of the Proleukin agreement and important updates on lung cancer while delivering on our key regulatory commercial manufacturing I'm grateful for the patients, physicians and regulators as well as our employees and cross functional teams in advancing our mission I would 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. Thank you.

Operator

This concludes today's conference call. Thank you for joining. You may now disconnect.

Powered by Quartr

Key Takeaways

  • FDA granted priority review to the BLA for lifileucel in advanced melanoma with a PDUFA date of November 25, 2023, and identified no major review issues or advisory committee requirements.
  • Iovance is now a commercial-stage company after acquiring Proleukin in May, recognized first product revenue, and will control IL-2 supply to support lifileucel launches and reduce future cost of goods.
  • The Iovance Cell Therapy Center maintains a >90% manufacturing success rate and is being scaled to supply lifileucel for over 2,000 patients annually, with plans to expand capacity to 5,000–10,000 patients.
  • Clinical progress includes the randomized Phase 3 TILVANCE-301 trial in frontline melanoma, positive Phase 2 results and FDA feedback for NSCLC (IOV LU-102), and encouraging Cohort 3a data combining lifileucel with pembrolizumab in first-line NSCLC.
  • After raising ~$161 million in July, Iovance’s cash position supports operations, manufacturing scale-up, commercial launch preparation and pipeline expansion through the end of 2024.
A.I. generated. May contain errors.
Earnings Conference Call
Iovance Biotherapeutics Q2 2023
00:00 / 00:00