Andrii Dodonov
Update 2.00PM EST: Adds latest share move and Oppenheimer’s downgrade
Cell therapy developer Cartesian Therapeutics (NASDAQ:RNAC) announced Tuesday that its lead asset, Descartes-08, reached the main goal in a mid-stage trial against the muscle disorder myasthenia gravis (MG).
In conjunction with the data, the Gaithersburg, Maryland-based biotech announced an agreement with certain investors to receive roughly $130M in gross proceeds as part of a PIPE (private investment in public equity) financing round.
However, the stock lost over a third as Oppenheimer downgraded to perform from outperform, noting a lack of clarity in the readout.
Citing topline data from a Phase 2b study for Descartes-08 in generalized MG, Cartesian (RNAC) said that the mRNA CAR-T cell therapy achieved the primary endpoint versus placebo, with statistical significance.
According to the company, Descartes-08, designed as an outpatient treatment, reached the study’s primary goal, a clinical measure calculated using the proportion of patients who achieved a reduction of five points or more in the MG Composite (MGC) score at month three.
As for safety, patients appeared to tolerate Descartes-08 well, with adverse events being transient and mostly mild, Cartesian (RNAC) added.
The company said it would discuss the results with the FDA as part of an end-of-phase 2 meeting by the year-end.
However, Oppenheimer analyst Matthew Biegler cited a lack of supportive biomarker analyses as a concern. Additionally, the analyst noted that the drug’s efficacy slipped from an intent-to-treat patient population to a per-protocol group. “We hope updated results, expected later this year, paint a clearer picture of this treatment’s potential,” Biegler wrote.
Meanwhile, detailing the terms of the financing agreement, Cartesian (RNAC) said it will be selling more than 3.5M shares of common stock and over 2.9M shares of its convertible preferred stock for $20 each.
The company intends to use net proceeds to fund its R&D activities and other corporate purposes, including working capital. The PIPE financing is expected to close around July 3.