It hasn’t been a great year for Iovance Biotherapeutics (IOVA -2.10%), an innovative mid-cap biotech company. The drugmaker’s shares have significantly lagged the market — advancing only about 5% so far this year. Iovance faces several issues, but it has plenty of opportunities, too.
In fact, several catalysts could lead the company to perform much better in 2025 than it did this year — and perhaps even better than the broader equity market. Let’s look deeper into how Iovance Biotherapeutics could pull that off.
Amtagvi could make significant progress
In February, Iovance earned approval from the U.S. Food and Drug Administration (FDA) for Amtagvi, a medicine for advanced melanoma (the most severe form of skin cancer). Amtagvi is a tumor-infiltrating lymphocyte (TIL) therapy. It is manufactured using patients’ own TIL cells, which can identify and kill cancer cells. The manufacturing process for Amtagvi takes 34 days. Due to the complexity of this type of therapy, it is manufactured in qualified authorized treatment centers (ATCs).
No wonder Amtagvi’s revenue isn’t impressive yet although it has grown significantly. In the third quarter, Iovance’s top line came in at $58.6 million, much higher than the $469,000 reported in the prior-year quarter. The challenge of administering Iovance’s TIL therapies is one of the reasons the company continues to lag the market.
Iovance is also unprofitable. It recorded a net loss per share of $0.28 in Q3, although that was better than the $0.46 loss per share it reported in the year-ago period.
Next year, Iovance’s revenue will grow even more as it makes headway into its addressable market for Amtagvi in the U.S., estimated to be 20,000 patients annually. As of the start of Q4, Iovance Biotherapeutics had treated 146 patients, including 25 in the second quarter, 84 in the third quarter, and 39 between Sept. 30 and early November.
Having already established a commercial footprint and a network of ATCs for Amtagvi, Iovance should see its pool of treated patients increase significantly next year in the U.S.
Furthermore, the company should earn approvals for Amtagvi in several other countries, including Canada and the U.K., and also in the European Union. While Iovance Biotherapeutics might not make significant headway in these regions next year, Amtagvi’s approval in these countries will still open up a vast opportunity.
The pipeline could provide some catalysts
Iovance will report clinical results next year that could move its stock price higher. Amtagvi is still being investigated in several studies, including as a potential combination therapy — with Merck‘s famous cancer drug Keytruda — to treat frontline melanoma. Amtagvi’s current indication only applies to patients who have already undergone certain treatments. A label expansion that essentially removes that requirement would increase the medicine’s target market.
Amtagvi’s could also have an attractive opportunity in non-small cell lung cancer (NSCLC). Lung cancer is the leading cause of cancer death in the world, and NSCLC makes up roughly 80% to 85% of cases of lung cancer. Iovance Biotherapeutics is running phase 2 and phase 3 studies for Amtagvi and other candidates in targeting NSCLC, and some data will be available next year.
Beyond that, Iovance’s pipeline features well over a dozen programs. That bodes well for the company’s prospects beyond 2025.
The long-term view
It’s impossible to predict the future, at least in great detail, accurately. Though Iovance Biotherapeutics might have a breakout year in 2025, a lot could also go wrong for the company, including regulatory setbacks, clinical trial failures, or Amtagvi not making significant headway into its addressable market. These potential pitfalls also highlight why Iovance is a risky biotech stock.
Though the company is innovative — TIL therapies are a somewhat novel method of treating cancer — it remains unprofitable, and its prospects still largely depend on it delivering a string of positive clinical results. Furthermore, the difficulty of administering TIL therapies complicates matters for Iovance Biotherapeutics. It extends the timing of cash flows from medicines compared to simple oral pills.
Iovance Biotherapeutics could overcome these obstacles and deliver outsized returns to patient investors. Those with heightened risk and volatility tolerance should consider initiating a small position in the stock. For everyone else, it’s best to watch from the sidelines for now.
