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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Gamida Cell Ltd | NASDAQ:GMDA | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.0327 | 0.0302 | 0.0304 | 0 | 01:00:00 |
– Primary and secondary endpoints were met, key exploratory endpoints supported clinical benefit in Phase 3 study of omidubicel in patients with hematologic malignancies; BLA submission anticipated in fourth quarter of 2021-
— Omidubicel commercial preparation underway, including the creation of Gamida Cell Assist, to support potential launch —
– GDA-201 demonstrated significant clinical activity in Phase 1 study of patients with non-Hodgkin lymphoma, with multiple complete responses observed; Phase 1/2 clinical trial planned with IND submission anticipated in the second half of 2021—
– Strengthened financial position with sale of $75M ordinary shares in December 2020 and $75M exchangeable senior notes in February 2021; sufficient liquidity to fund the company’s operations into the second half of 2022 —
– Company to host conference call at 8:30 a.m. ET today –
Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to finding cures for blood cancers and serious blood diseases, today reported financial results for the year and quarter ended December 31, 2020. The company also highlighted progress with omidubicel, an advanced cell therapy in Phase 3 clinical development as a potentially life-saving treatment option for patients in need of bone marrow transplant, and GDA-201, a natural killer (NK) cell immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma (NHL).
“It has been a significant year for Gamida Cell, marked by a number of important achievements that have brought us closer to developing cures for blood cancers and serious hematologic diseases. Omidubicel, an advanced cell therapy that has met all primary, secondary and exploratory endpoints in our Phase 3 study in patients with hematological malignancies, represents a potentially transformative treatment option. The data we presented in 2020, demonstrating the clinical benefit of omidubicel, position us to submit our first BLA for omidubicel in the fourth quarter of 2021,” said Julian Adams, Ph.D., chief executive officer of Gamida Cell. “We remain focused on both the BLA submission and preparing for potential commercial readiness, with the announcement of Gamida Cell Assist, a program designed to focus on patient access and a positive omidubicel experience for the patient and the transplant team. We are diligently working to bring omidubicel to patients as soon as possible.”
“We believe our NAM-based cell expansion technology has potential for NK cell expansion and we are developing GDA-201, an NK-cell immunotherapy for the treatment of hematologic and solid tumors in combination with antibody therapies. This year, we made meaningful progress with GDA-201, which has demonstrated impressive early results in patients with heavily pre-treated NHL in a Phase 1 investigator-sponsored study. Following these results, we plan to submit an IND to the FDA in the second half of 2021 and initiate a Phase 1/2 study,” Dr. Adams continued.
Omidubicel, an investigational advanced cell therapy for allogeneic bone marrow transplant
During the year, Gamida Cell made significant progress to advance its Phase 3 product candidate omidubicel, which is the first cell therapy for bone marrow transplant to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and which has the potential to be the first FDA-approved engineered cell therapy which can be used as a bone marrow transplant graft. The company presented primary, secondary and exploratory endpoints from the company’s international, multi-center, randomized Phase 3 study of omidubicel demonstrating its clinical benefit as a treatment option for patients in need of a bone marrow transplant.
In May, Gamida Cell reported that the phase 3 study of omidubicel achieved its primary endpoint, demonstrating a statistically significant reduction in time to neutrophil engraftment, a key milestone in recovery from a bone marrow transplant. It was shown that the median time to neutrophil engraftment was 12 days for patients randomized to omidubicel compared to 22 days for the comparator group (p<0.001). The Phase 3 study was designed to evaluate the safety and efficacy of omidubicel in patients with hematologic malignancies undergoing a bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant.
The Phase 3 study additionally met key secondary endpoints related to platelet engraftment, infections and hospitalization, all significant clinical measures in bone marrow transplant, as reported in October 2020. The prespecified secondary endpoints, analyzed in all randomized patients (intent-to-treat), were the proportion of patients who achieved platelet engraftment by day 42, the proportion of patients with Grade 2 or Grade 3 bacterial or invasive fungal infections in the first 100 days following transplant, and the number of days alive and out of the hospital in the first 100 days following transplant. All three secondary endpoints demonstrated a statistically significant improvement among patients who were randomized to omidubicel compared to the comparator group.
Recently, the results of the company’s Phase 3 study of omidubicel were presented at the Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy and Center for International Blood & Marrow Transplant Research. The data from the study relating to exploratory endpoints also supported the clinical benefit demonstrated by the study’s primary and secondary endpoints. Safety results were also presented, showing no significant difference between the two patient groups related to grade III/IV acute GvHD (14 percent for omidubicel, 21 percent for the comparator) or all grades chronic GvHD at one year (35 percent for omidubicel, 29 percent for the comparator). Transplants with umbilical cord blood, the comparator, have been historically shown to result in low incidence of GvHD in relation to other graft sources, and in this study, omidubicel demonstrated a similar GvHD profile. The rate of infection was significantly reduced for patients randomized to omidubicel, with the cumulative incidence of first grade 2 or grade 3 bacterial or invasive fungal infection for patients randomized to omidubicel of 37 percent, compared to 57 percent for the comparator (p = 0.027). Additionally, the study demonstrated a reduction in the incidence of viral infections. Non-relapse mortality was 11 percent for patients randomized to omidubicel and 24 percent for patients randomized to the comparator (p=0.09). Overall survival at one year following transplant was 73 percent for patients randomized to omidubicel and 62 percent for patients randomized to control (p=0.16).When considering the patient experience following transplant, faster hematopoietic recovery, fewer bacterial and viral infections and fewer days in hospital are all meaningful results and represent potentially important advancements in care.
Additional omidubicel highlights:
GDA-201, an innate NK cell immunotherapy
Corporate Highlights
Full Year 2020 Financial Results
2020 Financial Guidance
Gamida Cell expects cash used for ongoing operating activities in 2021 to range from $100 million to $120 million.
Gamida Cell expects that its current cash and cash equivalents will support the company’s ongoing operating activities into the second half of 2022. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken.
Expected 2021 Milestones
Gamida Cell plans to achieve the following milestones during 2021:
Omidubicel
GDA-201
Conference Call Information
Gamida Cell will host a conference call today, March 9, 2021, at 8:30 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the “Investors & Media” section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 1996281. A recording of the webcast will be available approximately two hours after the event, for approximately 30 days.
About Omidubicel
Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). In both Phase 1/2 and Phase 3 clinical studies (NCT01816230, NCT02730299), omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated.1,2 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn®, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.
Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
About GDA-201
Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.3 For more information on the clinical study of GDA-201, please visit www.clinicaltrials.gov.
GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.
About Gamida Cell
Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to timing of initiation and progress of and data reported from the clinical trials of Gamida Cell’s product candidates, anticipated regulatory filings, commercialization efforts and Gamida Cell’s expectations regarding its projected ongoing operating activities and cash runway, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Gamida Cell’s clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cell’s Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on March 9, 2021 and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cell’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Gamida Cell as of the date of this release.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION U.S. dollars in thousands
December 31,
2020
2019
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
127,170
$
41,838
Marketable securities
-
13,559
Prepaid expenses and other current assets
2,815
1,306
Total current assets
129,985
56,703
NON-CURRENT ASSETS:
Property, plant and equipment, net
18,238
6,298
Right-of-use assets
6,474
5,133
Other assets
786
641
Total non-current assets
25,498
12,072
Total assets
$
155,483
$
68,775
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables
$
6,329
$
1,164
Employees and payroll accruals
4,705
3,443
Current maturities of lease liabilities
2,532
1,870
Accrued expenses and other payables
7,988
4,918
21,554
11,395
NON-CURRENT LIABILITIES:
Liabilities presented at fair value
12,043
5,221
Employee benefit liabilities, net
768
773
Lease liability
5,378
4,101
Liability to Israel Innovation Authority (IIA)
17,003
12,302
35,192
22,397
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS' EQUITY:
Share capital
166
92
Share premium
375,280
238,992
Capital reserve due to actuarial loss
(441
)
(541
)
Reserve from financial assets measured at FVOCI
-
4
Accumulated deficit
(276,268
)
(203,564
)
Total shareholders' equity
98,737
34,983
Total liabilities and shareholders' equity
$
155,483
$
68,775
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS U.S. dollars in thousands (except share and per share data)
Year ended December 31,
2020
2019
2018
Operating expenses:
Research and development expenses, net
$
41,385
$
31,462
$
22,045
Commercial activities
8,748
4,692
-
General and administrative expenses
12,167
12,091
11,599
Operating loss
62,300
48,245
33,644
Financial expenses
10,640
3,325
20,259
Financial income
(236
)
(17,149
)
(1,042
)
Loss before taxes on income
72,704
34,421
52,861
Taxes on income
-
(70
)
70
Net loss
72,704
34,351
52,931
Net loss per share:
Basic net loss per share
$
1.66
$
1.17
$
10.53
Diluted net loss per share
$
1.66
$
1.69
$
10.53
CONSOLIDATED STATEMENTS OF CASH FLOWS U.S. dollars in thousands
Year ended December 31,
2020
2019
2018
Cash flows from operating activities:
Net loss
$
(72,704
)
$
(34,351
)
$
(52,931
)
Adjustments to reconcile net loss to net cash used in operating activities:
Adjustments to the profit or loss items:
Depreciation of property, plant and equipment and right-of-use assets
2,397
2,143
269
Financial loss (income), net
483
(775
)
(858
)
Share-based compensation
2,864
4,868
3,575
Change in employee benefit liabilities, net
94
126
(15
)
Amortization of premium on marketable securities
4
184
272
Revaluation of financial derivatives
6,822
(15,904
)
17,600
Revaluation of liability to IIA
4,302
2,531
2,037
16,966
(6,827
)
22,880
Changes in asset and liability items:
Increase (decrease) in other receivables, prepaid expenses and other assets
(1,626
)
(150
)
942
Increase (decrease) in trade payables
5,083
(821
)
(405
)
Increase in accrued expenses and other payables
3,454
2,807
2,296
6,911
1,836
2,833
Cash received during the year for:
Interest received
361
1,546
792
Interest paid
(161
)
(134
)
-
Net cash used in operating activities
(48,627
)
(37,930
)
(26,426
)
Cash flows from investing activities:
Purchase of property, plant and equipment
(11,804
)
(3,055
)
(1,645
)
Purchase of marketable securities
-
(32,021
)
(10,905
)
Proceeds from bank deposits
-
-
5,000
Investment in restricted bank deposits
(158
)
-
(150
)
Proceeds from maturity of marketable securities
13,551
38,742
-
Proceeds from sale of marketable securities
-
-
4,949
Net cash provided by (used in) investing activities
1,589
3,666
(2,751
)
CONSOLIDATED STATEMENTS OF CASH FLOWS U.S. dollars in thousands
Year ended December 31,
2020
2019
2018
Cash flows from financing activities:
Proceeds from secondary offerings, net
133,316
37,140
-
Receipt of grants from the IIA
399
224
612
Proceeds from issuance of shares, initial public offering (payment of issuance expenses), net
-
(238)
47,479
Payment of lease liabilities
(1,985)
(1,529)
-
Proceeds from exercise of options
650
132
2
Net cash provided by financing activities
132,380
35,729
48,093
Exchange differences on balances of cash and cash equivalents
(10)
101
31
Increase in cash and cash equivalents
85,332
1,566
18,947
Cash and cash equivalents at beginning of year
41,838
40,272
21,325
Cash and cash equivalents at end of year
$ 127,170
$ 41,838
$ 40,272
1 Horwitz M.E., Wease S., Blackwell B., Valcarcel D. et al. Phase I/II study of stem-cell transplantation using a single cord blood unit expanded ex vivo with nicotinamide. J Clin Oncol. 2019 Feb 10;37(5):367-374. 2 Gamida Cell press release, “Gamida Cell Announces Positive Topline Data from Phase 3 Clinical Study of Omidubicel in Patients with High-Risk Hematologic Malignancies,” issued May 12, 2020. Last accessed August 31, 2020. 3 Clinicaltrials.gov identifier NCT03019666
View source version on businesswire.com: https://www.businesswire.com/news/home/20210309005258/en/
For investors: Stephanie Ascher Stern Investor Relations, Inc. stephanie.ascher@sternir.com 1-212-362-1200 For media: Rhiannon Jeselonis Ten Bridge Communications rhiannon@tenbridgecommunications.com 1-978-417-1946
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