Analyst Conference Summary

biotechnology

conference date: August 6, 2026 @ 5:30 AM Pacific Time
for quarter ending: June 30, 2026 (second quarter, Q2 2026)

Forward-looking statements

Overview: Strong revenue growth.

Basic data (GAAP):

Revenue was $99 million, up 39% sequentially from $71.4 million, and up 66% from $60 million year-earlier.

Net Income was negative $47 million, up sequentially from negative $79 million, and up from negative $112 million year-earlier.

EPS (Earnings per Share), diluted, were negative $0.11, up sequentially from negative $0.19, and up from negative $0.33 year-earlier.

Guidance:

2026 revenue guidance unchanged at $350 to $370 million, but reviewing on strength of sales, with update to be provided in Q3.

Cash should fund operations into 2H 2028.

Conference Highlights:

Frederick Vogt, Interim President and CEO said, "Second-quarter revenue reached a record $99.3 million with gross margin of 56%, driven by continued U.S. Amtagvi demand. Based on our second-quarter performance and strong demand trends, we are reviewing our previously issued 2026 revenue guidance of $350 million to $370 million and will provide an update during the third quarter. Additionally, we continue to be excited by our clinical pipeline as lifileucel advances across other solid tumor indications including metastatic non-squamous non-small-cell lung cancer (NSCLC), the new registrational Saratoga trial in undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS), and metastatic serous endometrial cancer. Continued manufacturing and operating efficiencies support our sustainable growth, accelerate progress toward profitability, and advance our clinical pipeline with first-in-class, novel products in new solid tumor indications." Closing in on the cancer indications with the largest unmet needs. Vision is to reach tens of thousands of patients over the coming years.

Commercial momentum is continuing into Q3. Focus is on physician education. Moving from academic to community settings, which now are about one-third of our network. Real world response rates are convincing. U.S. ATCs are strategically located, allow for broad access. 31 day or less turnaround time. First ATC in Canada is ready. Australia ATCs are opening.

Revenue consisted of $91 million from U.S. sales of Amtagvi (lifileucel) plus $9 million from global sales of Proleukin. In Q2 2026 announced real world objective response rates of 52%. The Authorized treatment center (ATC) networkgrew to more than 95 U.S., Canadian, and Australian ATCs, with at least 110 expected to be active by the end of 2026. Community ATCs now make up a third of the network; expected to increase significantly over the next several quarters. In Q2 the marketing aruthoration application for Amtagvi was approved in Australia. Resubmitted in UK. Submitted in Switzerland, potential approval in 1H2027. Resubmitted in EU.

Amtagvi (lifileucel) In Q2 2026 announced real world objective response rates of 52%.

In Q2 2026 multiple investigator-sponsored clinical trials of lifileucel are enrolling in cutaneous squamous and Merkel cell carcinomas as well as other new solid tumor indications.

In Q2 2026 IOV-LUN-202 trial for previously treated metastatic non-squamous NSCLC enrollment was nearly complete in pivotal cohorts. Update due in Q4, sBLA in 2027. Market opportunity large.

In Q2 2026 Iovance announced positive early data for one-time lifileucel treatment for advanced undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) who were refractory to at least one prior line of systemic therapy. For six evaluable patients, the confirmed RECIST v1.1 ORR was 50%. Iovance plans to commence a single arm registrational trial in previously treated advanced UPS and DDLPS in Q3 2026. [note that if 1 less patient had had a response, the ORR would have dropped to 33%]

In Q2 2026 a Phase 3 trial combining lifileucel with pembrolizumab is underway for frontline advanced melanoma. There will be an early interim analysis. The trial will also serve to confirm accelerated approval in second-line melanoma. Data will be presented at ESMO.

In Q2 2026 new positive data was reported for previously tradted metastatic serious endometrial cancer. Talking with FDA about a protocol amendment for an expedited approval pathway.

In Q2 2026 multiple investigator-sponsored clinical trials of lifileucel are enrolling in cutaneous squamous and Merkel cell carcinomas as well as other new solid tumor indications.

As of Q1 2026 a Phase 1/2 trial of IOV-4001, a PD-1 inactivated TIL therapy, in previously treated advanced melanoma and NSCLC, is ongoing.

As of Q1 2026 a Phase 1/2 trial of IOV-3001, a second-generation, modified IL-2 analog, is ongoing. Safety cohorts are ramping through multiple dose levels as of May 2026.

For Q2 2026, a Phase 1/2 trial was initiated for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 TIL therapy.

Cash and investments ended at $297 million, down sequentially from $319 million.

Total expenses were $151 milllion, consisting of: cost of sales $44 million, R&D $59 million, SG&A $39 million, depreciation and amortization $10 million. Other income $3 million. Income tax benefit $1 million.

Q&A:

Lung update coming? Enrollment should complete soon. Then an update, some data before all evaluations are complete. Looking very good right now.

Demand? Awareness increasing, ATC network growing. In Q2 helped by publication of real world data back in Q1. This is organic demand, not a timing issue.

We are seeing strong demand so far in Q3, expecting it to continue into Q4. Expanding the sales force.

So far we are seeing that the lifileuco combination with pembro gets rapid responses and a strong response rate.

Lung cancer 202 study goal? Goal is to exceed prior durability, we have a longer follow up in this trial. Similar to melanoma. Looking to success in the market place for a one-time, durable therapy. We did change lymphodepletion to make it less burdensome on patients.

Replimune results impact on guidance? There is a lot of noise out there. If it gets approved we see it as competitive like TVEC, so it will have a lot of barriers. We think Amtagvi is a more compelling product. We are far ahead in this space.

Patient volume by type? If on two or fewer lines of therapy have a good response rate and are mainly at community centers. Community ATCs started ramping in 2025. They have higher ceilings than the academic center ATCs.

Biggest restraint on growth going forward? We are seeing earlier line referals coming in. That gives more time to treat. We are getting tumor tissue earlier, which helps with manufacturing. Constraint is getting referals to ATCs.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: