Investors reined in risk Wednesday ahead of data from a phase 3 trial that could support the eventual approval of one of ImmunoGen Inc.'s (IMGN 1.07%) most anticipated drugs and news regarding presentations planned for an upcoming conference. Investors' flight to safety caused shares in ImmunoGen to lose 20.3% of their value
ImmunoGen's mirvetuximab soravtansine is an antibody-drug conjugate (ADC) in late-stage trials for use in patients with platinum-resistant ovarian cancer who have received at least one prior treatment.
There's no set date for when management will release results from this registration-enabling study, but the company did indicate on its earnings conference call earlier this month that results from its Forward I trial would be available by June 30. If the data is good, ImmunoGen plans to file for a U.S. Food and Drug Administration OK and European approval in the second half of 2019.
After the closing bell today, management said it will have 11 posters for other drugs that are in its development pipeline at the American Association of Cancer Research (AACR) Annual Meeting from March 29 to April 3, 2019.
Check out the latest ImmunoGen earnings call transcript.
In hopes of a positive outcome, ImmunoGen's been bulking up cash on its balance sheet to support a potential launch. The company started the year with $325 million on the books following a public offering and the sale of its royalty stream on Kadcyla, an ADC for HER2-positive breast cancer that's licensed to Roche Holdings and that won FDA approval in 2013.
The company spent $166.4 million on its operations in 2018, and it anticipates its current cash stockpile can "fund its operations at least a year beyond the release of top-line results from the phase 3 Forward I trial".
In addition to mirvetuximab soravtansine's monotherapy results, management also expects to have initial results from its Forward II program available this year. Forward II is a triplet combination approach to treating ovarian cancer that includes mirvetuximab soravtansine, carboplatin, and Avastin.