GlycoMimetics CEO Harout Semerjian told investors in March that phase 3 blood cancer results could “fundamentally impact our company's trajectory.” And the CEO was absolutely right, just not in the way he hoped.
Monday, GlycoMimetics reported the failure of the trial—spurring a 72% stock drop that crushed the company's share price to 51 cents in premarket trading Monday morning, compared to $1.83 at the close on Friday. Investors drove the biotech’s valuation down into penny stock territory as they chewed over the implications of a phase 3 study that tested the E-selectin antagonist uproleselan in patients with acute myeloid leukemia (AML).
Here’s what went down. GlycoMimetics randomized 388 people with relapsed or refractory AML to take uproleselan or placebo on top of a chemotherapy regimen. Overall survival was 13 months in patients taking uproleselan, compared to 12.3 months in people on placebo.
The result caused the trial to miss its primary endpoint. That is a problem for GlycoMimetics. The biotech weathered setbacks such as the failure of its Pfizer-partnered sickle cell disease prospect and loss of the Big Pharma bedfellow to emerge with a pipeline focused on uproleselan. The next most advanced asset, a successor to the candidate Pfizer dropped, cleared phase 1a in January.
GlycoMimetics originally expected to complete the phase 3 AML trial in 2020 and pushed past delays to reach a readout it flagged as an enabler of a filing for FDA approval. The biotech was targeting a $650 million to $850 million near-term potential market opportunity in the U.S. alone. Instead, the trial failed, leaving GlycoMimetics looking to a phase 2/3 National Cancer Institute (NCI) trial for salvation.
The NCI trial is testing uproleselan in a different patient population: newly diagnosed AML patients. The NCI suspended the study in November 2021 after reaching the end of the phase 2 portion of the trial. GlycoMimetics said results of a preplanned phase 2 event-free survival interim analysis will be reported when available.
The clock is ticking. GlycoMimetics ended March with $31.3 million in cash and equivalents. The biotech previously told investors that the money it had at the end of last year would fund operations through the fourth quarter of 2024.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.