Exhibit
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Press Release, dated February 25, 2019, Gamida Cell Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Company Update
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GAMIDA CELL LTD.
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February 25, 2019
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By:
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/s/ Shai Lankry
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Shai Lankry
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Chief Financial Officer
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Reported additional immune reconstitution data for NiCord supporting clinical potential
for bone marrow transplant: In February, translational data from the completed Phase 1/2 study of NiCord were reported at the 2019 Transplantation & Cellular Therapy (TCT) Meetings of American Society for Blood and
Marrow Transplantation and Center for International Blood and Marrow Transplant Research demonstrating that recipients who received NiCord had rapid and robust reconstitution of key immune cells. Successful immune reconstitution is an
important factor in the recovery of patients undergoing bone marrow transplant.
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Reported initial data from Phase 1/2 study of NiCord in severe aplastic anemia: At
the 2019 TCT Annual meeting, data were reported from the ongoing Phase 1/2 study of NiCord in patients with severe aplastic anemia. In the initial cohort of three patients, all successfully underwent a bone marrow transplant
consisting of NiCord plus a haploidentical stem cell graft. The rapid cord engraftment, sustained hematopoiesis and accelerated immune recovery in treatment refractory observed in these patients enable the initiation of a second
cohort of patients to be treated with NiCord as a stand-alone graft. Patient enrollment in the second cohort is expected to begin in the first
half of 2019.
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Announced encouraging data from Phase 1 study of NAM-NK in non-Hodgkin Lymphoma and
multiple myeloma: During the 2019 TCT Annual Meeting, data reported from the ongoing Phase 1 study of NAM-NK in patients with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) demonstrated that NAM-NK was clinically
active, with three complete responses observed in patients with NHL and one complete response in a patient with MM. These data, along with safety data showing that NAM-NK was generally well tolerated, support continued clinical
development, and Gamida Cell is planning to initiate a multi-center, Phase 1/2 clinical study of NAM-NK in patients with blood cancers in 2020.
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Entered into agreement with Editas Medicine to evaluate
potential to gene edit NAM-NK cells: In February, Gamida Cell announced an agreement with Editas Medicine, Inc. to evaluate the potential use of Editas Medicine’s CRISPR technology to edit NAM-NK cells. Through this
agreement, the companies aim to rapidly discover optimized NAM-NK cells that could be used to improve the treatment of blood cancers and solid tumors.
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Formed strategic collaboration with Be The Match BioTherapies: In January 2019,
both organizations announced a collaboration to expand the use of bone marrow transplant to treat hematologic malignancies and serious blood disorders. Under the terms of the collaboration agreement, the organizations will explore
opportunities to work together across Gamida Cell’s ongoing clinical development program for NiCord, including the ongoing Phase 3 clinical study. Be The Match BioTherapies has an extensive history of involvement in the delivery of
cord blood units for transplant and broad access to cord blood banks globally.
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Appointed Thomas Klima as Chief Commercial Officer: In January, the company
announced the appointment of Thomas Klima as Chief Commercial Officer. Mr. Klima brings nearly 20 years of global experience in the pharmaceutical industry with expertise in cellular therapy, hematology, oncology and transplantation. During his career, he has played key roles in
building commercial organizations and leading multiple successful product launches.
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Appointed Nurit Benjamini to Board of Directors: In January, the company
appointed Nurit Benjamini to Gamida Cell’s board of directors and chair of the board’s audit committee. Ms. Benjamini has served as chief financial officer of TabTale Ltd. since 2013. Previously, she held a number of chief financial
officer positions, including at Wix.com Ltd., Sigma Designs Israel Ltd. and Compugen Ltd.
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Initiate Cohort 2 in the Phase 1/2 study evaluating NiCord as stand-alone graft in severe aplastic anemia in the first half of 2019
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Complete enrollment in Phase 3 study of NiCord in patients with hematologic malignancies in the second half of 2019
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Report topline data from the Phase 3 study of NiCord in patients with hematologic malignancies in the first half of 2020
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Complete BLA filing for NiCord in hematologic malignancies in the second half of 2020, should Phase 3 data be positive
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Complete patient enrollment in the ongoing Phase 1 study in the second half of 2019
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Present additional data at a medical meeting in the second half of 2019
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Initiate multi-center, Phase 1/2 clinical study in 2020
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At December 31, 2018, Gamida Cell had total cash, cash equivalents and available-for-sale securities of $60.7 million, compared to $41.1 million at December 31, 2017.
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Research and Development expenses in 2018 were $22.0 million, compared to $15.0 million in 2017. The increase was attributable mainly to a $5.4 million increase in
clinical activities relating to the advancement of Gamida Cell’s clinical programs as well as an increase of $1.6 million in other R&D expenses.
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General and administrative expenses were $11.6 million in 2018, compared to $4.5 million in 2017. The increase was attributable mainly to a $2.9 million increase in
expenses related to expanding the management team and establishing the U.S. headquarters, an increase of $2.0 million in non-cash stock-based compensation expenses, and $2.2 million in professional services expenses incurred during
the IPO process, rent and other expenses.
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Finance expenses, net, were $19.2 million in 2018, compared to $0.5 million in income, in 2017. The increase was primarily due to non-cash expenses resulting from
revaluation of warrants and the revaluation of royalty-bearing grant IIA liability.
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Net loss for 2018 was $52.9 million, compared to a net loss of $19.1 million for 2017.
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December 31,
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2018
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2017
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ASSETS
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CURRENT ASSETS:
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Cash and cash equivalents
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$
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40,272
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$
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21,325
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Available-for-sale financial assets
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20,417
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14,758
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Short term deposits
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-
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5,000
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Prepaid expenses and other current assets
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1,502
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2,539
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Total current assets
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62,191
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43,622
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NON-CURRENT ASSETS:
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Property and equipment, net
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2,311
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940
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Other assets
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662
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360
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Total non-current assets
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2,973
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1,300
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Total assets
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$
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65,164
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$
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44,922
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LIABILITIES AND SHAREHOLDERS' EQUITY
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CURRENT LIABILITIES:
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Trade payables
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$
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1,985
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$
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2,390
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Employees and payroll accruals
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2,888
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1,517
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Accrued expenses and other payables
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1,832
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669
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Total current liabilities
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6,705
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4,576
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NON-CURRENT LIABILITIES:
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Liabilities presented at fair value
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24,049
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10,300
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Employee benefit liabilities, net
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183
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200
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Liability to Israel Innovation Authority (IIA)
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9,540
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6,890
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Total non-current liabilities
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33,772
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17,390
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SHAREHOLDERS' EQUITY:
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Ordinary shares
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67
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2
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Preferred shares
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-
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38
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Share premium
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193,953
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139,311
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Capital reserve due to actuarial loss
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(77
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)
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(79
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)
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Available for sale reserve
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(43
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)
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(34
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)
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Accumulated deficit
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(169,213
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)
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(116,282
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)
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Total shareholders' equity
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24,687
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22,956
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Total liabilities and shareholders' equity
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$
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65,164
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$
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44,922
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Year ended
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December 31,
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2018
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2017
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Operating expenses:
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Research and development expenses, net
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$
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22,045
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$
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15,018
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General and administrative expenses
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11,599
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4,472
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Operating loss
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33,644
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19,490
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Financial expenses
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20,259
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718
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Financial income
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(1,042
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)
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(1,197
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)
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Loss before taxes on income
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52,861
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19,011
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Taxes on income
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70
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-
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Net Loss
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52,931
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19,011
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Other comprehensive loss:
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7
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69
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Total comprehensive loss
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$
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52,938
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$
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19,080
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Loss per share - basic and diluted (in U.S. dollars)
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$
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10.53
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$
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27.56
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