Without any drugs on the market, ImmunoGen's (NASDAQ: IMGN) investors are in a holding pattern.
Fortunately it won't be too long before the company reads out data for its lead drug, mirvetuximab.
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Unfortunately, as much as investors were hoping otherwise, the fourth-quarter earnings release wasn't the day that data was revealed.
ImmunoGen results: The only number that really matters
What happened with ImmunoGen this quarter?
- ImmunoGen actually used $166.4 million for operations in 2018, but the vast majority of that was offset by a secondary offering in June.
- After the quarter ended, the company continued its moves to improve its financial situation by selling the remaining royalties it could have received on sales of Roche's Kadcyla, grossing the company $65 million.
- ImmunoGen presented promising early-stage data for two blood cancer drugs, IMGN779 and IMGN632, at the American Society of Hematology (ASH) meeting in December.
- During the quarter, the company completed enrollment of a mid-stage study of mirvetuximab in combination with the chemotherapy carboplatin and Roche's Avastin. Data should be available this year.
- But mostly, the fourth quarter was just spent waiting for data from a phase 3 study called Forward 1 that's testing mirvetuximab as a monotherapy for ovarian cancer. Data from the study is expected sometime in the first half of this year.
What management had to say
ImmunoGen's chief medical officer, Anna Berkenblit, talked about the encouraging data for IMGN779 in patients with acute myeloid leukemia (AML), and plans for the drug: "Encouragingly, in data presented at ASH, we saw anti-leukemia activity in more than 40% of relapsed/refractory patients. This year, we expect to establish the recommended phase 1 dosing schedule for IMGN779 to move forward within combination regimens in AML."
Berkenblit also went over expectations for the Forward 1 study: "We have designed the study looking for PFS improvement from three and a half months in the control arm to six months in the experimental arm, which translates into a hazard ratio of 0.58."
Here's a quick lesson in clinical-trial lingo if you need it: PFS is "progression-free survival," or the time it takes for a patient's tumor to begin growing again while the patient remains alive. Hazard ratio is a statistical measure of the differences between the two groups (arms) of the study; a 0.58 hazard ratio translates into a 42% improvement for mirvetuximab over the control arm of the study, where the patients receive chemotherapy.
On the potential for the drug to improve survival, Berkenblit pointed out that "the study is not powered to show a statistically significant improvement in overall survival. However, we would expect that all of the endpoints are consistent, and so we'd expect to see a trend in overall survival in the right direction."
Management expects to end the year with between $135 million and $140 million in the bank. That figure assumes a positive result for Forward 1, and the anticipated increased spending associated with getting the drug submitted for approval and launch-ready in the second half of the year.
Now, for investors, it's back to waiting.
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