Iovance cuts staff on slower cell therapy sales growth

A year ago, Iovance was celebrating becoming the first company to win FDA clearance for a cell therapy used to treat a solid tumour. Now, it is cutting staff in the face of sales growth that has not met initial expectations.

In its second-quarter financial filing, Iovance said it was planning to shed 19% of its workforce of more than 630 in order to save cash and keep it operating through the remainder of 2025 and 2026, saying the aim is to "prioritise key manufacturing and R&D efforts."

The move comes despite $54 million in sales in the three-month period for autologous tumour-infiltrating lymphocyte (TIL) therapy Amtagvi (lifileucel), which was approved by the FDA in February 2024 as the first treatment option for patients with advanced melanoma after anti-PD-1 and targeted therapies.

Iovance has said it believes Amtagvi has $1 billion-plus annual sales potential, thanks to its potential to treat several thousand melanoma patients per year in the US and a list price of $515,000, but it still has a long way to go to meet that threshold.

The company is modelling full-year sales of $250 to $300 million in its first full year on the market, having predicted in earlier guidance that the product would make up to $475 million.

The restructuring aims to shave around $100 million off annual costs, starting in the fourth quarter of this year, but won't have any impact on Iovance's R&D pipeline with all projects still in play, according to the company.

Amtagvi is a personalised one-shot therapy based on T-cells extracted from a patient's tumour at an authorised treatment centre, expanded in the lab and reinfused to fight the cancer throughout the body.

Unlike CAR-T therapies – the success of which Iovance is hoping to emulate with Amtagvi – there is no need for cellular modification, although patients undergo a similar lymphodepletion regimen to help make room for the new immune cells.

Iovance chief executive Frederick Vogt said he expects growth of the cell therapy to continue in the latter half of the year as the number of authorised treatment centres (ATCs) in the US increases, "and large community practices begin treating patients."

The company is also expecting its first approval for Amtagvi outside the US "imminently," said Vogt. The therapy is currently under review in Canada, the UK, and Australia, with a filing in Switzerland due in the coming months, although Iovance withdrew a marketing application in the EU after discussion with regulators and is "working to determine a resubmission strategy."

It estimates that there are more than 20,000 melanoma patients worldwide who could be eligible for treatment with Amtagvi, if approved.