Leap Therapeutics Announces Major Restructuring and Clinical Trial Termination

Leap Therapeutics, a Massachusetts-based biotech company, has unveiled a significant restructuring plan that includes expanding its previously announced layoffs and terminating its sole remaining clinical trial. This move comes as the company struggles to navigate challenging market conditions and preserve its dwindling cash reserves.

Expanded Layoffs and Financial Implications

Leap Therapeutics has announced that it will now lay off 75% of its workforce, a substantial increase from the 50% reduction plan announced just last month. The company, which started 2025 with 52 full-time employees, including 41 in research and development roles, expects the layoffs to cost approximately $3.2 million in severance fees. This drastic measure is part of what the company calls a "retooled strategy" aimed at reducing spending and preserving capital.

The biotech firm reported having $32.7 million in cash at the end of March, but the expanded layoffs suggest a dire financial situation. Leap's stock price has been trading below $1 since a disappointing clinical trial readout earlier this year, further complicating its financial outlook.

Clinical Trial Termination and Asset Reevaluation

In a surprising move, Leap has decided to wind down its DeFianCe clinical trial, which was evaluating sirexatamab, an anti-DKK1 antibody, as a second-line treatment for colorectal cancer (CRC). This decision effectively terminates the company's only ongoing clinical trial.

Despite claiming to see potential in sirexatamab's results, CEO Douglas Onsi cited "current market conditions" as the primary reason for discontinuing the trial. The company had previously narrowed its focus to sirexatamab as a second-line CRC treatment after disappointing results in first-line CRC and gastric cancer studies.

Leap is now "exploring strategic alternatives" for both sirexatamab and FL-501, a preclinical GDF-15 neutralizing antibody. These alternatives may include a potential sale or partnership for the assets.

Clinical Data and Future Prospects

While announcing the trial termination, Leap highlighted some positive trends from the DeFianCe study. The company reported an overall response rate (ORR) of 33% for the sirexatamab arm compared to 20.2% for the placebo cohort, based on investigator assessment. However, statistically significant benefits were only observed in specific subgroups, such as patients with high levels of DKK1, those without prior exposure to anti-VEGF therapy, or those with liver metastasis.

Despite these potential silver linings, Leap's decision to terminate the trial and explore strategic alternatives for its assets suggests a shift away from internal development. The company's future now hinges on its ability to find partners or buyers for its drug candidates in an increasingly challenging biotech market.