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Share Name | Share Symbol | Market | Type |
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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 | |
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0.00 | 0.00% | 0.0327 | 0.0302 | 0.0304 | 0 | 01:00:00 |
– Announces USAN selection of omidubicel as nonproprietary name for company’s investigational NAM-expanded hematopoietic stem cells (formerly known as NiCord®) –
– Patient enrollment in Phase 3 study of omidubicel expected to be completed in second half of 2019; Topline results expected in first half of 2020 –
– Phase 1 clinical study of GDA-201 (formerly known as NAM-NK) continues to progress, with additional data expected in 2H19 –
Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, today reported financial results for the quarter ended March 31, 2019. The company also highlighted continued progress in advancing its clinical development candidates: omidubicel1 (formerly known as NiCord®), an investigational advanced cell therapy in Phase 3 clinical development designed to enhance the life-saving benefits of hematopoietic stem cell (bone marrow) transplant, and GDA-201 (formerly known as NAM-NK), an investigational, natural killer (NK) cell-based cancer immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma and multiple myeloma.
“Gamida Cell is focused on transforming the treatment landscape for patients with blood cancers and rare, serious hematologic diseases. We are pleased that omidubicel has been selected as the nonproprietary name for NiCord, highlighting our progress toward bringing this important cell therapy to patients in need of a bone marrow transplant,” stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. “We have also made several key personnel appointments this year that reflect our strategic focus on commercial preparedness, including hiring our first chief commercial officer and nominating new board members who bring commercial, operational and financial experience to Gamida Cell’s board of directors.”
Dr. Adams continued, “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,” Dr. Adams concluded.
Company Highlights
Anticipated 2019-2020 MilestonesGamida Cell’s anticipated program milestones in 2019-2020 are as follows:
Omidubicel
GDA-201
First Quarter 2019 Financial Results
2019 Financial GuidanceGamida Cell continues to expect cash used for ongoing operating activities in 2019 to range from $35-$40 million, 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. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding that may be received or business development activities that may be undertaken.
Conference Call InformationGamida Cell will host a conference call today, May 7, 2019, 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” 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 2277888. A replay of the webcast will be available for approximately 30 days.
About OmidubicelOmidubicel (formerly known as NiCord®), the company’s lead clinical program, 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).1 Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU. In a Phase 1/2 clinical study, omidubicel demonstrated rapid and durable time to engraftment and was generally well-tolerated.2 A Phase 3 study evaluating omidubicel in patients with leukemia and lymphoma is ongoing in the U.S., Europe and Asia.3 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia.4 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.
About GDA-201Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201 (formerly known as NAM-NK), an innate natural killer (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.5
Omidubicel and GDA-201 are investigational therapies, and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.
About Gamida CellGamida Cell is a clinical-stage biopharmaceutical company committed to developing advanced cell therapies with the potential to cure blood cancers and rare, serious hematologic diseases. We are leveraging our proprietary nicotinamide-based, or NAM-based, cell expansion technology to develop product candidates designed to address the limitations of cell therapies. For additional information, please visit www.gamida-cell.com.
Cautionary Note Regarding Forward Looking StatementsThis press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to the patient enrollment in and timing of initiation and progress of and data reported from the clinical trials of Gamida Cell’s product candidates, and Gamida Cell’s expectations regarding its projected operating expenses 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 variability, 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 of Gamida Cell’s public filing on Form 20-F, filed with the SEC on February 25, 2019, 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.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION U.S. dollars in thousands March 31, December 31, 2019 2018ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 43,749 $ 40,272 Available-for-sale financial assets 6,507 20,417 Prepaid expenses and other current assets 684 1,502Total current assets
50,940 62,191NON-CURRENT ASSETS:
Property and equipment, net 2,782 2,311 Right-of-use assets 6,668 - Other assets 657 662Total non-current assets
10,107 2,973Total assets
$ 61,047 $ 65,164LIABILITIES AND EQUITY
CURRENT LIABILITIES:
Trade payables $ 1,341 $ 1,985 Employees and payroll accruals 2,580 2,888 Current maturities of lease liabilities 2,156 - Accrued expenses and other payables 1,739 1,832Total current liabilities
7,816 6,705NON-CURRENT LIABILITIES:
Liabilities presented at fair value 25,031 24,049 Employee benefit liabilities, net 276 183 Lease Liabilities 4,671 - Liability to Israel Innovation Authority (IIA) 10,108 9,540Total non-current liabilities
40,086 33,772SHAREHOLDERS' EQUITY:
Share capital 68 67 Share premium 197,967 193,953 Capital reserve due to actuarial gains (160) (77) Available-for-sale reserve (10) (43) Accumulated deficit (184,720) (169,213)Total shareholders' equity
13,145 24,687Total liabilities and shareholders' equity
$ 61,047 $ 65,1641 Gamida Cell’s lead development candidate consists of omidubicel (expanded hematopoietic stem cells) and differentiated immune cells, including T cells. Gamida Cell refers to the two components collectively as “omidubicel.”
2 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.
3 ClinicalTrials.gov identifier NCT02730299.
4 ClinicalTrials.gov identifier NCT03173937.
5 ClinicalTrials.gov identifier NCT03019666.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190507005128/en/
Jaren Irene Maddenjaren@gamida-cell.com617-892-9084
Krystle Gibbs (media)krystle@tenbridgecommunications.com508-479-6358
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