Gamida Cell Ltd. (NASDAQ: GMDA) reported Q1 EPS of ($0.31), $0.14 better than the analyst estimate of ($0.45).

First Quarter 2020 Financial Results

• Research and development expenses in the first quarter of 2020 were $7.9 million, compared to $7.3 million for the same period in 2019. The increase was mainly due to clinical activities relating to the advancement GDA-201, offset by grants received from the Israel Innovation Authority.
• Commercial expenses in the first quarter of 2020 were $1.5 million compared to $1.0 million for the same period in 2019. The increase was mainly attributed to commercial readiness activities for omidubicel.
• General and administrative expenses were $3.0 million for the first quarter of 2020, compared to $2.8 million in the same period in 2019. The increase was due mainly to expenses associated with being a publicly traded company.
• Finance income, net, were $1.7 million for the three months ended March 31, 2020, compared finance expenses, net of $4.4 million in the same period in 2019. The increase was primarily due to noncash expenses resulting from revaluation of warrants.
• Net loss for the first quarter of 2020 was $10.6 million, compared to a net loss of $15.5 million in the same period in 2019.
• As of March 31, 2020, Gamida Cell had total cash, cash equivalents and available-for-sale securities of $40.3 million, compared to $ 55.4 million as of December 31, 2019. The March 31, 2020, cash position excludes approximately $56 of net proceeds after underwriting discounts and commission and offering-related expenses from the company’s recent public follow-on offering.

“Last week, we were extraordinarily pleased to report that our Phase 3 study of omidubicel met its primary endpoint of demonstrating a significant reduction in time to neutrophil engraftment, a key milestone in recovery from a bone marrow transplant. Shortening the time to engraftment is clinically meaningful, as it can reduce a patient’s time in the hospital and decrease likelihood of infection. These positive study results represent an important step forward for Gamida Cell and the transplant community,” stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. “Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. FDA and has the potential to be the first FDA-approved bone marrow transplant graft. Our dedicated team is working hard to begin submitting the biologics license application for omidubicel to the FDA on a rolling basis in the fourth quarter.”

“Our Phase 3 omidubicel data underscore the potential of our proprietary NAM technology platform, and we’re very encouraged by the data in the ongoing Phase 1 study of our second development candidate, GDA-201, an investigational natural killer cell therapy. Natural killer cells have attracted significant attention as a potential breakthrough approach to treat cancer, and we are proud to be at the forefront of advancing this field. We anticipate reporting additional data on GDA-201 in the second half of 2020 and are working to initiate a multi-center Phase 1/2 clinical study in patients with lymphoma next year,” Dr. Adams continued.

2020 Financial Guidance

Gamida Cell expects cash used for ongoing operating activities in 2020 to range from $60 million to $70 million.

Gamida Cell expects that, after accounting for the completion of its public follow-on offering, its current cash, cash equivalents and available-for-sale securities will support the company’s ongoing operating activities into the second half of 2021. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding beyond the follow-on offering, or business development activities that may be undertaken.

For earnings history and earnings-related data on Gamida Cell Ltd. (GMDA) click here.