Iovance executive Brian Gastman said on Tuesday at a conference that the company’s science was never the hindrance, but getting its therapy to patients.

  • Iovance is looking to expand Amtagvi indications into sarcoma, endometrial cancer, and more. 
  • In lung cancer, executive Gastman said Iovance is “imminently finishing this trial very soon” and expects “a much larger dataset presented by the end of this year, all leading to an sBLA in 2027.”
  • The company recorded nearly $100 million in revenue in the second quarter.

Iovance Biotherapeutics (IOVA) said on Tuesday it now has “a clear line of sight to profitability,” thanks to record sales of its approved skin cancer drug Amtagvi as it prepares for a stretch of data and trial updates slated into year-end.

“We had a record quarter in Q2 with nearly $100 million in revenue. Our margin is now 56%, which is the best ever, and we have cash runway over $300 million, which is enough to take us into mid-2028. Moreover, allowed us to now announce that we have a clear line of sight to profitability,” Brian Gastman, executive vice president of translational medicine and research, said at the H.C. Wainwright 28th Annual Global Investment Conference.

Iovance’s Amtagvi is a one-time treatment made from immune cells taken from a patient’s own tumor, expanded, and given back. It was granted accelerated approval in early 2024 by the U.S. Food and Drug Administration for certain adult patients with unresectable or metastatic melanoma.

Gastman said the bottleneck was never the science. “TIL (Tumor-Infiltrating Lymphocyte therapy) always has worked. The problem was always getting it to the patients.” The company now has more than 95 treatment centers and “expect[s] by the end of the year to hit 110,” with more than 95% of U.S. patients within 200 miles of a site.

Iovance’s Upcoming Catalysts

Iovance has several near-term catalysts lined up. The most immediate catalyst is a third-quarter update to its full-year 2026 revenue guidance. After posting record Q2 sales of $99.3 million, management is reviewing the current $350–370 million range.

In late October, Iovance will present supporting results for Amtagvi plus Merck’s blockbuster cancer drug Keytruda in frontline melanoma at a conference. The trial, TILVANCE-301, is meant to confirm Amtagvi's current approval and support earlier use in the treatment sequence for advanced or metastatic melanoma.

A formal program update on a pivotal mid-stage non-small-cell lung cancer study is due in the fourth quarter, while a potential UK approval of Amtagvi remains possible later this year.

In lung cancer, Gastman said Iovance is “imminently finishing this trial very soon” and expects “a much larger dataset presented by the end of this year, all leading to an sBLA in 2027.” The company is also developing the drug for endometrial cancer, and is talking with the U.S. Food and Drug Administration about a faster path.

IOV-5001, a next-generation version of Iovance’s tumor-infiltrating lymphocyte (TIL) therapy, designed to keep a powerful immune signal at the tumor instead of throughout the body, is expected to “imminently also start accruing patients,” including in harder-to-treat cancers such as colorectal, triple-negative breast, and head and neck, Gastman said.

How Did IOVA Retail Traders React?

On Stocktwits, retail sentiment around IOVA stock rose from ‘neutral’ to ‘bullish’ over the past 24 hours, while message volume stayed at ‘normal’ levels.

A Stocktwits user opined that the stock is cheap at current prices, provided the trial updates slated ahead.

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Another noted the confidence exhibited by the company management at recent conferences and said, “It is amazing this stock is still in the single digits!”

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A third user hoped IOVA would be worth more than Moderna in the future, which is valued at about $57 billion as of Tuesday’s market close. IOVA currently has a market cap of about $4 billion.

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IOVA stock has gained nearly 243% year-to-date. 

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