Gamida Cell reports Q1 loss of $15.5M vs. $7.4M a year ago
As of March 31, Gamida Cell had total cash, cash equivalents and available-for-sale securities of $50.3M, compared to $60.7M as of December 31, 2018. Gamida Cell continues to expect cash used for ongoing operating activities in 2019 to range from $35M-$40M, reflecting anticipated expenditures to advance the company's clinical programs. Gamida Cell expects that its cash, cash equivalents, available-for-sale securities and short-term debt will support the company's capital needs through the data readout for the Phase 3 clinical study of omidubicel, which is expected in the first half of 2020. CEO Julian Adams said, "We are pleased that the multi-center, randomized Phase 3 study of omidubicel is progressing, with patient enrollment expected to be complete by the end of this year and topline data anticipated in the first half of 2020. Positive data from the study would enable the submission of our first biologics license application next year, which would be a significant achievement. Earlier this year, we also reported encouraging data from the Phase 1 clinical study of our natural killer cell product candidate, GDA-201, previously known as NAM-NK. The multiple complete responses observed emboldened us to begin scaling up our manufacturing process to enable the evaluation of a cryopreserved formulation of GDA-201 in a multi-center, multi-dose Phase 1/2 clinical study in patients with non-Hodgkin lymphoma next year."