Iovance Biotherapeutics at H.C. Wainwright Conference: Strategic Growth and Efficiency

On Tuesday, 09 September 2025, Iovance Biotherapeutics (NASDAQ:IOVA) presented at the H.C. Wainwright 27th Annual Global Investment Conference. The company outlined its strategic initiatives for growth, focusing on the commercial expansion of Amtagvi (lifileucel) for advanced melanoma, and operational efficiency to reduce costs. While the potential market for Amtagvi is projected at over $1 billion in the U.S., the company is also addressing cost reductions and manufacturing improvements to enhance profitability.

Key Takeaways

• Iovance aims to reduce operating costs by $100 million over the next four quarters.
• The company is expanding Amtagvi into new indications, including non-small cell lung cancer and endometrial cancer.
• A pivotal Phase 3 study for frontline melanoma shows promising results with a 65% response rate.
• Over 250 million patient lives are covered by insurance, supporting market access.
• A new agreement with McKesson Biologics aims to expand access through community practice centers.

Financial Results

• Market Potential: Amtagvi’s U.S. market potential exceeds $1 billion.
• Cost Reduction: The company targets a $100 million reduction in operating costs over the next four quarters.
• Gross Margin Expansion: Focused on increasing manufacturing volume and operational efficiencies to improve margins.
• Insurance Coverage: Over 250 million patient lives covered, with more than 75% of Amtagvi patients under private insurance.

Operational Updates

• Manufacturing: The FDA-approved facility in Philadelphia has reduced the turnaround time for Amtagvi to 33 days.
• Authorized Treatment Centers: 80 centers in the U.S., covering over 90% of the patient population within 200 miles.
• Community Practice Centers: Efforts to bring large centers online for expanded access, supported by McKesson Biologics.
• Restructuring: Aimed at right-sizing the organization to achieve cost efficiencies.

Future Outlook

• Expansion of Indications: Ongoing trials for non-small cell lung cancer and endometrial cancer, with data expected this year.
• Frontline Melanoma: Pivotal trial (TIL1301) shows a 65% response rate, supporting potential approval.
• Next-Generation TIL Therapies: Advancements in PD-1 inactivated TIL and IL-12 tethered TIL, with trials planned for next year.

Iovance Biotherapeutics’ strategic focus on innovation and cost efficiency positions it for potential growth in the competitive biotech sector. For a detailed discussion, readers are encouraged to refer to the full transcript.

Full transcript - H.C. Wainwright 27th Annual Global Investment Conference:

Sara, COO, Iovance Biotherapeutics: COO at Iovance Biotherapeutics, a biotechnology company developing and manufacturing T-cell-based immunotherapies for solid and liquid cancers. With that, Igor, the floor is yours.

Igor, Iovance: Morning, everyone. Thanks for having us. I’ll be making forward-looking statements as part of this presentation and refer to our filings for the SEC for full disclosure of risks and uncertainties. Iovance, I expect many of you are familiar with the story of our commercial biotech, and our mission is to innovate, develop, and deliver to patients tumor-infiltrating lymphocyte or TIL cell therapies for treatment of solid tumors. We have two approved products in our portfolio. One is Amtagvi, lifileucel, that’s approved in the U.S. in 2024 and in Canada recently for treatment of patients with advanced post-PD-1 melanoma. It’s the first T-cell therapy, one-time T-cell therapy, to receive approval of the FDA for treatment of solid tumors. It’s only the first treatment option for patients who’ve progressed and post-PD-1 in melanoma. The second product is Proleukin.

It’s an IL-2 analog that we market globally, and that’s used as part of the treatment regimen of Amtagvi. We’re very much focused on the commercial growth of lifileucel and Amtagvi at the moment in the U.S., and we expect it to have a market potential in the U.S. of over $1 billion. Our pipeline includes a range of clinical trials that generally focus on three areas. One is expanding lifileucel and Amtagvi to new indications, most notably non-small cell lung cancer, where we’re conducting a pivotal study, ELION202, for which we expect to announce additional results this year. Another indication is endometrial cancer. The second direction is moving Amtagvi to earlier lines of therapy. The notable study there is TIL1301 in frontline melanoma in combination with pembrolizumab.

The third area is extending our leadership in the TIL space and developing next generations of TIL therapies, including PD-1 inactivated TIL and IL-12 tethered TIL. Next slide, please. The clicker doesn’t seem... Oh, there we go. The technology platform is tumor-infiltrating lymphocytes. It’s uniquely suited for treatment of solid tumors in that it’s polyclonal. The therapy is individualized, and it’s a one-time therapy that leverages patients’ own immune system to fight cancer. We expect this platform in our company to address a very significant market opportunity. There have been a number of approvals of cell therapies for liquid tumors for hematological malignancies in the past decade, but we’ve been able to achieve the first approval of a T-cell therapy for a solid tumor cancer. More than 90% of all cancer cases in the U.S. are solid tumors.

The initial three indications that we target have a very significant unmet need and opportunity. It’s melanoma, where, as I mentioned, we have approval in the U.S. and recently this year received approval in Canada. We’re also planning for approvals in the EU, UK, Australia, and Switzerland. The second indication is lung, which is very large, and actually the largest number of solid cancer deaths in the U.S. are from lung cancer. The third indication is endometrial. In melanoma, the initial target population in the U.S. is about 8,000 patients per year. It’s a second line plus, patients who’ve progressed on PD-1, anti-PD-1 antibodies, and, if relevant, BRAF-MEK therapy. Extending to ex-U.S., we’re looking at a market potentially in second line of about 30,000 patients. Potential extension to first line would bring this market to about 70,000 patients. The unmet need is very significant.

While there are PD-1 and other therapies approved in first-line setting, more than half of the patients will progress within 12 months. Second-line patients, upon progression, their median survival is about five months if they don’t have a BRAF mutation and about three months if they have a BRAF mutation. Amtagvi is the first FDA-approved treatment for patients with advanced melanoma who’ve progressed on anti-PD-1 therapy. We presented updated five-year follow-up data at ASCO this year, demonstrating overall survival of close to 20% at five years. The overall response rate is 31%. Median duration of response is more than three years. We more recently presented additional real-world evidence data from Amtagvi in advanced melanoma that actually showed response rates even higher than what we have on the label. The physician-assessed response rate was 48.8%, close to 50%.

What’s notable, patients who have received two or fewer prior lines of therapy had a response rate of close to 61%. That’s, again, one of our areas of focus, moving Amtagvi to patients who are early in the treatment journey because that’s when they can benefit most from this therapy. The treatment journey, it’s a one-time therapy, so we’ve been working since launch in 2024 on shortening this journey for patients, making it more convenient. The reimbursement approval is now about three weeks or less. It’s roughly been cut in half or even better since launch. We more recently shortened the turnaround time from the time we receive cells in the manufacturing facility to Amtagvi being ready for shipment back to the patient to 33 days and are continuing to work on further reducing that.

We’ve built and commissioned and have FDA approval of our own manufacturing facility in Philadelphia Navy Yard. It allows us a lot of flexibility to adjust and increase demand as needed. It also allows us to improve quality and reduce cost of goods. That’s a very significant focus for us for this year to increase gross margins of Amtagvi through both increasing volume, where we amortize fixed cost over a larger volume of manufacturing, but also through a number of operational efficiency, effectiveness initiatives to reduce various costs that go into manufacturing. Amtagvi, another area of focus for us being ensuring good access of patients to Amtagvi. We have about 80 authorized treatment centers in the U.S. today, and more than 90% of addressable patient populations live within 200 miles from an authorized treatment center.

One of the focus areas for this year, in addition to selectively adding a few more key ATCs, is to bring online large community practice centers in the spirit of moving Amtagvi treatment earlier in the patient journey, making it more convenient for patients to access. As part of that effort, we recently signed an agreement with McKesson Biologics, again, to make it more convenient for large community centers to access Amtagvi. Market access has been very strong. More than 250 million patient lives are covered by insurance at the moment. As I mentioned, the typical time to financial clearance is three weeks and faster in many cases. Most of the Amtagvi patients are covered by private insurance, more than 75%. Planning to expand beyond the initial indication and post-PD-1 melanoma.

In frontline melanoma, we presented data at ASCO in 2024 in combination with pembrolizumab, demonstrating a response rate of 65% by RECIST, including complete response of 30%. That’s unprecedented in this setting. It is, as far as I know, better than anything that’s been demonstrated for these patients in the past. Progression-free survival was about 65% at six months and 12 months. This indication is the focus of the ongoing clinical phase three study, TIL1301, that is enrolling patients in the U.S., Canada, Europe, Australia, with the dual purpose. One purpose is to convert approval in second-line and post-PD-1 melanoma from accelerated to full approval. The second objective is to achieve approval in frontline melanoma, initially accelerated and then potentially converting that as part of the same clinical trial to full approval.

Importantly, this trial design’s been very closely negotiated with the FDA and EMA and is designed to clearly show contribution of components because the control arm is pembrolizumab. The active arm is lifileucel or Amtagvi plus pembro. It very clearly is intended to show contribution of Amtagvi relative to pembro alone. Moving beyond melanoma, the next major indication we’re targeting is non-small cell lung cancer. In our clinical trial, we are evaluating TIL therapy for patients who don’t have BRAF or other major mutations, not BRAF, EGFR or other major mutations. The target population in the U.S. in the second-line lung cancer is about 50,000 patients, very, very significant. Adding the EU, we’re looking in total at about 100,000 patients. It is an indication with significant unmet medical need. It’s a leading cause of U.S. cancer deaths, accounting for approximately one in five cancer deaths in the U.S.

at the moment. The real-world overall survival is about six months. Five-year survival rate is about 9%. You can tell, and there’s really nothing approved in this setting in second-line non-small cell lung cancer. Chemo is the only option that’s typically used, and it’s really not very active at all. We’re conducting this ELION202 clinical trial, which is a registrational trial. The design’s been discussed and agreed with the FDA. It’s enrolling patients with both PD-1 high and PD-1 low status, and we have seen activity in both PD-1 low and high settings. For this study, we expect to present additional data, most likely in a press release later this year, and then present that data in a major meeting following the initial high-level release. Previously, this is data back from about two years ago. This was an interim update demonstrating 26% response rate.

What’s important in the setting is both ORR and the durability. As of the most recent update, more than 71% of confirmed responders had duration of response of more than six months. Moving on to endometrial cancer, this is one of the more recent indications we’ve started in the clinic with our Oletalucil therapy. More than 90% of all uterine cancers are endometrial, and they account for about 14,000 annual deaths in the U.S. and about 100,000 deaths globally. Similar to melanoma and lung cancer, we’re looking for the initial indication in post-PD-1 setting, so second line. In this setting, there’s no standard of care that’s available today. Chemotherapy is typically used, but it’s not very active, and the overall response to chemo is in the mid-teen range and very short durability.

We’re looking to develop Amtagvi, lifileucel in this setting for both patients with mismatch repair proficient and mismatch repair deficient endometrial cancers. This is the clinical trial that we’re running today, first in human in the setting. We expect to present some initial data from this clinical trial, top line, potentially later this year. One additional next-generation therapy that I mentioned, this is a clinical trial, first in human, of PD-1 inactivated TIL, where we inactivate PD-1 on the T cells. Currently, we are conducting this first in human trial in advanced melanoma, post-PD-1, and also non-small cell lung cancer. This is potentially another update we anticipate presenting later this year, showing some initial top line data from this next-generation TIL therapy clinical trial. To summarize, Iovance, we’re a commercial stage biotech.

We’re working on a tumor-infiltrating lymphocyte or TIL platform that is uniquely suitable for treatment of a broad range of solid tumors. Our initial focus is on commercial growth of Amtagvi in advanced melanoma, where we anticipate the market potential of over $1 billion in the U.S., then expanding the indication to non-small cell lung cancer and endometrial cancer, potentially other solid tumors, moving to earlier lines of therapy from post-PD-1 setting in melanoma to frontline melanoma with our pivotal trial, and then expanding the technology to next generations, including PD-1 inactivated TIL, for which we also may release data this year, and next-generation IL-12 tethered TIL, which is now in preclinical development and for which we plan to file an IND and bring it into the clinic to patients next year. Significant focus this year is also on operational efficiencies, gross margin expansion, and cost reductions.

We’ve implemented a restructuring a couple of months ago, and that is intended to reduce operating costs by about $100 million in the next four quarters to expand the gross margin and to essentially right-size the organization to the demand we’re seeing in the market and enable us to get to break even sooner based on our revenue projections. I’ll pause here. Thank you.

Sara, COO, Iovance Biotherapeutics: Thank you, Igor and Iovance. We do have a few more minutes. If anyone has any questions for the team, feel free to come up and follow up with them. They’ll be around for a few more minutes if you’d like. Otherwise, thank you so much.

Igor, Iovance: Thank you, Sara.

Sara, COO, Iovance Biotherapeutics: Thank you.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.