Iovance Biotherapeutics, Inc. (IOVA)
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AGM 2024

Jun 11, 2024

Moderator

Director of Elections has hereby confirmed that a quorum is present and that this meeting is duly and properly convened. The polls are now open for voting online. If you are a stockholder of Iovance and wish to vote online, please do so by following the instructions in the online meeting portal. As a reminder, you will need your 12-digit control number in order to access the meeting and vote your shares through the online portal. If you require any assistance or experience any technical difficulties, please contact the Continental Stock Transfer and Trust technical support team by following the instructions in the online portal. If you have any questions, you may use the online portal to submit them at any time. At the conclusion of the legal portion of the meeting, Dr. Vogt will give the brief presentation of the company's business.

Following the presentation, approximately 15 minutes has been set aside for a Q&A session. If you have already voted by proxy and do not wish to change your vote, you do not need to cash it out online today. Iovance's proxy statement and notice of the meeting were made available on May 9th, 2024, to persons holding shares as of the record date of April 17th, 2024.

Speaker 4

We will now discuss and vote on each of the proposals scheduled to come before the meeting. I'd like to introduce Jean-Marc Bellemin, Iovance's Chief Financial Officer, who has been appointed to serve as the Secretary for the annual meeting and will conduct this part of the meeting. Jean-Marc?

Jean-Marc Bellemin
CFO, Iovance Biotherapeutics

Thank you, Jean. Good morning. We will address any questions during the Q&A session following Dr. Vogt's presentation. As a reminder, please refer to our rules of conduct for the meeting, a copy of which has been posted to the online meeting portal. Stockholders are generally limited to one question each, and because our time is limited, we may not be able to answer all of your questions during the Q&A session. The polls are now closed. We will now proceed to a vote on the proposals. Election of Directors. The first matter on which stockholders are voting is the election of our nominated directors to serve until the 2025 annual meeting of stockholders. Our nominating committee has recommended, and our board of directors has approved the director nominees described in our proxy statement. Approval of Executive Compensation.

The second matter on which stockholders are voting is the approval on a non-binding advisory basis of the compensation of the named Executive Officer of Iovance Biotherapeutics, as disclosed in the proxy statement. Ratification of Ernst & Young LLP. The third matter on which stockholders are voting is the ratification of our appointment of Ernst & Young LLP as the company's independent registered public accounting firm for the fiscal year ending December 31st, 2024. As described in our proxy statement, the board of directors recommends that stockholders ratify the appointment of Ernst & Young LLP. Approval of Amendment to 2018 Equity Plan.

The fourth matter on which stockholders are voting is the approval of an amendment to the company's 2018 Equity Incentive Plan to increase the number of shares of the company's common stock authorized for issuance thereunder from $29,700,000 shares to $36,700,000 shares and per-share recapture from the company's 2014 Equity Incentive Plan, as disclosed in the proxy statement. Approval of Amendment to 2020 Employee Stock Purchase Plan. The final matter on which stockholders are voting is for the approval of an amendment to the company's 2020 Employee Stock Purchase Plan to increase the number of shares of the company's common stock authorized for issuance thereunder from 1.4 million shares to 1.9 million shares, as disclosed in the proxy statement. We will now hear from Alwyn, who will read the preliminary report of the inspector of election as to each of the proposals on which the stockholders voted. Alwyn?

Moderator

Thank you. Based on the preliminary report, each of the nominees has been elected as directed to serve until the 2025 annual meeting of stockholders. The stockholders have approved the compensation of the named executive officers, as proposed in the proxy statement. Three, the stockholders have ratified the appointment of Ernst & Young LLP as Iovance's independent registered public accounting firm for the fiscal year ending September 31st, 2024. The stockholders have approved the amendment to the company's 2018 Equity Incentive Plan. And five, the stockholders have approved the amendment to the company's 2020 Employee Stock Purchase Plan. The final results will be disclosed in the company's current report on Form 8-K, and the company expects to file no later than the next business day.

Jean-Marc Bellemin
CFO, Iovance Biotherapeutics

Thank you.

Speaker 4

The inspector's report indicates that all of the proposals before this meeting have passed. I hereby adjourn the legal portion of the meeting. I would like to take this opportunity to thank you for your attendance and continued interest in Iovance.

Jean-Marc Bellemin
CFO, Iovance Biotherapeutics

I will now ask Dr. Vogt to give a presentation about Iovance's business and operations, and there will be an opportunity for questions from stockholders after his presentation. At the outset, I would just like to note that during the course of Dr. Vogt's presentation and the Q&A session, Dr. Vogt or other representatives of the company may make forward-looking statements regarding future events or the future financial performance of the company. Such statements are predictions only, and actual events or results could differ materially from those made in any forward-looking statements due to a number of risks and uncertainties, including assumption about future events based on current expectations, planned business development efforts, near and long-term objectives, potential new business strategies, organization changes, changing markets, marketing efforts, future business performance, and outlook. I refer you to the company's more recent filing with the U.S.

Securities and Exchange Commission, which contains and identifies additional information covering factors that could cause the result to differ materially from those contained in our projection or forward-looking statements. Except as required by law, the company does not assume any responsibility for updating any forward-looking statements, and the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Fred?

Frederick Vogt
CEO, Iovance Biotherapeutics

Thank you, Jean-Marc, and welcome everyone to the 2024 annual stockholders' meeting. On slide two, please take a look at our forward-looking statements. Slide three summarizes our global leadership position in innovating, developing, and delivering TIL therapies, tumor infiltrating lymphocyte therapies for patients with cancer. We have two commercial products, Amtagvi, recently approved, as well as Proleukin, and you can see some of our numbers here, including our number of patients that we've treated so far and the number of lives that we've covered that have covered Amtagvi prescriptions and the number of treatment centers we have, as well as our pipeline of people and assets and some of our partners. Slide four covers our pipeline, and in particular, the green highlighted section of slide 4 shows our label expansion opportunities for Amtagvi, including our programs in non-small cell lung cancer and endometrial cancer.

Slide 5 shows our unique mechanism of action from the one-time individualized autologous tumor infiltrating lymphocyte therapy, including Amtagvi, which deploys the patient's own T cells to fight cancer. Moving to slide six, I'll talk for a minute about the recent approval of Amtagvi, also known as lifileucel. On slide seven, we highlight that Amtagvi is the first approved treatment after progression on anti-PD-1 therapy and BRAF MEK inhibitors, and the only approved treatment in this line. It was recently approved in February of 2024, and we've launched the product successfully. Slide eight summarizes the melanoma population in the United States and the enormous opportunity for Amtagvi. We have 8,000 deaths annually in the United States from melanoma.

The drug-treated population is shown here in the bar graph, and I'll point out that Amtagvi is already the preferred second line for subsequent therapy in the NCCN guidelines for treatment of melanoma. On slide nine, we highlight the label of Amtagvi. This is the approved label. Cohort four demonstrated an objective response rate of 31.5%. The median duration of response not reached after 18.6 months of follow-up. We also have support of pooled data on the label as well. Slide 10 summarizes Amtagvi's durability of four years from one of our more recent presentations. Again, it shows excellent durability after a four-year period, and it shows that patients that respond tend to respond for very long periods of time. Slide 11 summarizes the Amtagvi patient journey. As it stands today in the commercial marketplace, patients are enrolled and get reimbursement approval. They schedule for tumor tissue procurement.

Manufacturing occurs, lymph depletion, and then they receive Amtagvi as a single course of therapy with support of a short course of Proleukin, also given to the patient at the same time. Slide 12 highlights our commercial manufacturing facility known as the Iovance Cell Therapy Center. We supply Amtagvi to the U.S. market from this facility as well as from a neighboring CMO facility. Expansions are underway to make this an even larger facility right now. Slide 13 summarizes some of the capacity of that facility today, as the building can support up to 2,000 patients a year today, and we're ramping up to that number right now, and we're in progress on site expansions to take us up to 5,000 patients per year. Slide 14 switches to a summary of our authorized treatment centers throughout the United States.

Right now, we have 50 ATCs active right now as of early June in the United States. They're spread pretty equally across the United States. We're going to be moving towards 70 ATCs by the end of 2024, and we target ATCs that have high patient volume, good NCCN status, NCCN status, KOLs, and have existing cell therapy experience and patient capacity. Slide 15 summarizes our market access. With this product, with Amtagvi, we have a very favorable mix of payers, which includes a large percentage of commercial payers, as well as Medicare, IPPS, and cancer centers, which are able to bill at full cost, as well as Medicare Advantage, which behaves a lot like commercial insurance. And this leads to a very strong reimbursement that we've expected, and it seems to be bearing out quite well right now from the hospitals.

Moving to slide 16, we'll talk very quickly about the expansion plans for Amtagvi and melanoma. On slide 17, we talk about our European and Canadian expansion plans. There's 14,000 annual deaths in these ex-U.S. target markets. We're planning this quarter to submit an MAA to the European Medicines Agency, EMA, seeking approval for lifileucel in the European Union. We're also submitting in the second half of 2024 regulatory dossiers to the U.K. and Canadian health authorities. Moving to slide 18, we had an ASCO. At ASCO, we had an update on our frontline strategy in melanoma. This would be a label expansion both in the United States as well as in other countries potentially as well.

We demonstrated that ICI-naïve patients with advanced melanoma treated with lifileucel plus pembrolizumab in combination in the frontline setting led to 2/3 of patients with a confirmed response by iRECIST 1.1 criteria. Almost 1/3 of the patients had confirmed complete responses. All evaluable patients have regression of target lesions. The vast majority of patients' responses were still ongoing, and median PFS was not reached at nearly two years of median follow-up, which goes well for our TILVANCE-301 study. Our TILVANCE-301 study has an early entry read based on ORR as the primary endpoint and a dual primary endpoint of PFS that can be read after that. Slide 19 summarizes the TILVANCE-301 study, including the control arm. Moving to slide 20, I'll just discuss our TIL therapy pipeline for a little bit here.

On slide 21, we highlight the significant market potential in solid tumors outside of melanoma. You can see lung and endometrial highlighted here. These are two of our lead programs. Again, 91% of all cancer cases in the United States and around the world are solid tumor cancers, and we have in the United States alone 1.8 million new cases of solid tumors every year. Moving to slide 22, I'll talk a little bit about our program in non-small cell lung cancer. This is what we believe is our next registrational indication. We presented in 2023 positive pulmonary data from our phase II advanced non-small cell lung registrational trial. We're running in multiple cohorts across multiple trials right now, but we have a registrational program running in our LUN202 study. We have, of course, in the United States, a very high burden from non-small cell lung with 125,000 annual deaths.

It's the leading cause of U.S. cancer deaths. And on the right of the slide, you can see the drug-treated population and the significant market opportunity for approved therapy and this indication. On slide 23, we summarize endometrial cancer, which is another indication that we intend to move very quickly in and are moving right now on. We're going to be moving with new checkpoint inhibitors moving into the frontline setting. We can be moving into the second line setting with TILs, and we think this is going to be a very useful indication for us. We have 13,000 annual deaths from uterine cancer, which is the major subtype of endometrial cancer in the United States. And we're going to be targeting both MMR deficient and MMR proficient, unlike some of the other agents out there that don't have that sort of data.

We think we can target both with TIL therapy. Our phase II trial of lifileucel is planned in 2024 and should be initiated very soon. Finally, on slide 24, I'd like to talk about the next generation TIL programs that we have in our pipeline. We work on genetically modified TILs. You'll see some of that in our pipeline, especially in our studies of IOV-4001 and now IOV-5001, which we'll be bringing to the clinic early 2025. We've got work to optimize TIL compositions, next generation processes, and expanding into new regimens, including our asset that we recently presented at ASCO, known as IOV-3001, which is an IL-2 analog, the replacement from Novartis that we believe has superior properties to the current Proleukin product that we own. It may give us additional opportunities in the future.

I'll move on to slide 25 and talk about some corporate summaries and milestones. On slide 26, we summarize our cash position. We had cash, cash equivalent investments, and restricted cash of $362 million as of March 31st. On slide 27, I'll cover our anticipated milestones. We've already obtained FDA approval, which is a very significant milestone for the company on February 16, 2024. We're submitting EMA regulatory dossiers, as I mentioned earlier, and ex-U.S. dossiers in the first and second halves, and we're still continuing to meet with FDA on the non-small cell lung program. We continue to report clinical and preclinical data, including data on our COMTO 21A cohort that we presented at ASCO, as well as data on IOV-3001 and other assets throughout the year. We continue to enroll in IOV-LUN-202, our non-small cell lung registrational trial.

The other milestones on this slide, you can read, but we're executing our launch and then making sure that the manufacturing supply for our launch is successful. Finally, on slide 28, I'll just summarize some corporate highlights very quickly. It's a very large market opportunity in high unmet medical need cancers that Iovance can potentially fulfill. We've been focused on post-ICI solid tumors. ICI means immune checkpoint inhibition. We're expanding into new combinations, new tumor types, earlier lines of therapy, and genetic modifications. We have late-stage trials in melanoma and non-small cell lung. We'll be starting one soon in endometrial, and we're running the first-in-human trial of genetically modified PD-1 inactivated TIL. We've got the first approved, FDA-approved T-cell therapy for solid tumor cancer. FDA granted accelerated approval for Amtagvi in advanced melanoma earlier this year.

Our TILVANCE-301 Phase III confirmatory trial in frontline advanced melanoma is running and has Fast Track designation. We've got a defined registrational strategy in non-small cell lung. We've got the largest manufacturing footprint in this industry with our in-house iCTC facility, as well as ample capacity for U.S. launch and global clinical trials, and we have additional capacity with our contract manufacturer. Finally, we're a fully integrated company built for commercial success, experienced cross-functional cell therapy teams. We have certifying capacities across leading U.S. cancer centers now, 50 and growing, and we have our IovanceCares proprietary platform for ordering and following up on TIL patients. With that, on slide 29, I'll thank the investors for their attention, and I'll open the floor for questions.

Moderator

Okay, it looks like we have no questions. That concludes our meeting. I'd like to thank our shareholders for your support of Iovance.

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