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 quarter ended March 31, 2020. The company also highlighted continued progress in advancing its clinical development candidates: 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, an investigational, natural killer (NK) cell-based cancer immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma (NHL) and multiple myeloma.
"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.
Company Highlights
COVID-19 Operational Impact
Gamida Cell has taken important steps to help ensure the safety of employees and their families and to reduce the spread of COVID-19. In early March, Gamida Cell established a work-from-home policy for all employees, other than those performing or supporting business-critical laboratory-based experiments and manufacturing-related activities. For those employees, the company has implemented stringent safety measures designed to comply with applicable government guidelines instituted in response to the COVID-19 pandemic. Gamida Cell has maintained frequent communication with its business partners and clinical sites as the COVID-19 situation has progressed.
"We are proud of the resilience of our employees and are thankful for the continued dedication and support of our clinical study investigators and participating patients. COVID-19 has slightly slowed the cadence of new patient enrollment in the ongoing clinical study of GDA-201 and changed how we conduct our day-to-day business. However, we anticipate that COVID-19 will have limited overall impact on our clinical development programs, timing of regulatory submission for omidubicel, or manufacturing readiness for the potential launch of omidubicel in 2021," said Dr. Ronit Simantov, chief medical officer at Gamida Cell.
Expected 2020-2021 Milestones
Gamida Cell targets achieving the following milestones during 2020-2021:
Omidubicel
GDA-201
First Quarter 2020 Financial Results
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.
Conference Call Information
Gamida Cell will host a conference call today, May 21, 2020, 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 +1-409-216-0605 (international) and refer to conference ID number 8530548. A recording of the webcast will be available approximately two hours after the event, for approximately 30 days.
About Omidubicel
Omidubicel, 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). 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 both Phase 1/2 and Phase 3 clinical studies, omidubicel demonstrated rapid and durable time to engraftment and was generally well tolerated. 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.
About GDA-201
Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201, 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 (NCT03019666).
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 Cell
Gamida Cell is an advanced cell therapy company committed to finding cures for 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.
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 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 and other sections of Gamida Cell's Annual Report on Form 20-F, filed with the Securities and Exchange Commission (SEC) on February 26, 2020, its Report on Form 6-K filed with the SEC on May 18, 2020 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 |
||||||||
|
March 31, |
December 31, |
||||||
|
2020 |
2019 |
||||||
ASSETS |
|
|
||||||
|
|
|
||||||
CURRENT ASSETS: |
|
|
||||||
Cash and cash equivalents |
$ |
40,292 |
|
$ |
41,838 |
|
||
Marketable securities |
|
- |
|
|
13,559 |
|
||
Prepaid expenses and other current assets |
|
1,637 |
|
|
1,306 |
|
||
Total current assets |
|
41,929 |
|
|
56,703 |
|
||
|
|
|
||||||
NON-CURRENT ASSETS: |
|
|
||||||
Property and equipment, net |
|
8,543 |
|
|
6,298 |
|
||
Right-of-use assets |
|
5,820 |
|
|
5,133 |
|
||
Other assets |
|
637 |
|
|
641 |
|
||
Total non-current assets |
|
15,000 |
|
|
12,072 |
|
||
Total assets |
$ |
56,929 |
|
$ |
68,775 |
|
||
LIABILITIES AND SHAREHOLDERS' EQUITY |
|
|||||||
|
|
|||||||
CURRENT LIABILITIES: |
|
|||||||
Trade payables |
$ |
3,098 |
|
$ |
1,164 |
|
||
Employees and payroll accruals |
|
2,549 |
|
|
3,443 |
|
||
Current maturities of lease liabilities |
|
1,535 |
|
|
1,870 |
|
||
Accrued expenses and other payables |
|
2,922 |
|
|
4,918 |
|
||
|
|
10,104 |
|
|
11,395 |
|
||
NON-CURRENT LIABILITIES: |
|
|||||||
Liabilities presented at fair value |
|
2,773 |
|
|
5,221 |
|
||
Employee benefit liabilities, net |
|
773 |
|
|
773 |
|
||
Lease liability |
|
4,920 |
|
|
4,101 |
|
||
Liability to Israel Innovation Authority (IIA) |
|
13,077 |
|
|
12,302 |
|
||
|
|
21,543 |
|
|
22,397 |
|
||
CONTINGENT LIABILITIES AND COMMITMENTS |
|
|||||||
|
|
|||||||
SHAREHOLDERS' EQUITY: |
|
|||||||
Share capital |
|
92 |
|
|
92 |
|
||
Share premium |
|
239,897 |
|
|
238,992 |
|
||
Share premium |
|
(541 |
) |
|
(541 |
) |
||
Capital reserve due to actuarial gains |
|
- |
|
|
4 |
|
||
Available-for-sale reserve |
|
(214,166 |
) |
|
(203,564 |
) |
||
Total shareholders' equity |
|
25,282 |
|
|
34,983 |
|
||
|
|
|||||||
Total liabilities and shareholders' equity |
$ |
56,929 |
|
$ |
68,775 |
|
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS |
||||||||||||
U.S. dollars in thousands (except share and per share data) |
||||||||||||
|
Three months ended
|
|
Year ended
|
|||||||||
|
|
2020 |
|
2019 |
|
2019 |
||||||
|
|
|
|
|
||||||||
Operating expenses: |
|
|
|
|
|
|
||||||
Research and development, net |
|
$ |
7,879 |
|
|
$ |
7,283 |
|
|
$ |
31,462 |
|
Commercial activities |
|
|
1,468 |
|
|
|
998 |
|
|
|
4,692 |
|
General and administrative |
|
|
2,994 |
|
|
|
2,815 |
|
|
|
12,091 |
|
|
|
|
|
|
|
|
||||||
Operating loss |
|
|
12,341 |
|
|
|
11,096 |
|
|
|
48,245 |
|
|
|
|
|
|
|
|
||||||
Finance expense |
|
|
919 |
|
|
|
4,734 |
|
|
|
3,325 |
|
Finance income |
|
|
(2,658 |
) |
|
|
(349 |
) |
|
|
(17,149 |
) |
|
|
|
|
|
|
|
||||||
Loss before taxes on income |
|
|
10,602 |
|
|
|
15,481 |
|
|
|
34,421 |
|
Taxes on income |
|
|
- |
|
|
|
26 |
|
|
|
(70 |
) |
|
|
|
|
|
|
|
||||||
Net loss |
|
|
10,602 |
|
|
|
15,507 |
|
|
|
34,351 |
|
|
|
|
|
|
|
|
||||||
Net loss per share:
|
|
|
|
|
|
|
||||||
Basic loss per share |
|
$ |
0.31 |
|
|
$ |
0.62 |
|
|
$ |
1.17 |
|
|
|
|
|
|
|
|
||||||
Diluted loss per share |
|
$ |
0.31 |
|
|
$ |
0.62 |
|
|
$ |
1.69 |
|
CONSOLIDATED STATEMENTS OF CASH FLOWS |
||||||||||||
U.S. dollars in thousands |
||||||||||||
|
|
Three months ended
|
|
Year ended
|
||||||||
|
|
2020 |
|
2019 |
|
2019 |
||||||
Cash flows from operating activities: |
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
||||||
Net loss |
|
$ |
(10,602 |
) |
|
$ |
(15,507 |
) |
|
$ |
(34,351 |
) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: |
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
||||||
Adjustments to the profit or loss items: |
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
||||||
Depreciation of property, equipment and right-of-use assets |
|
|
550 |
|
|
|
542 |
|
|
|
2,143 |
|
Financial income, net |
|
|
(132 |
) |
|
|
(191 |
) |
|
|
(775 |
) |
Cost of share-based compensation |
|
|
899 |
|
|
|
1,091 |
|
|
|
4,868 |
|
Change in employee benefit liabilities, net |
|
|
- |
|
|
|
11 |
|
|
|
126 |
|
Amortization of premium on available-for-sale financial assets |
|
|
4 |
|
|
|
50 |
|
|
|
184 |
|
Revaluation of financial derivatives |
|
|
(2,448 |
) |
|
|
3,907 |
|
|
|
(15,904 |
) |
Revaluation of liability to IIA |
|
|
722 |
|
|
|
568 |
|
|
|
2,531 |
|
|
|
|
(405 |
) |
|
|
5,978 |
|
|
|
(6,827 |
) |
Changes in asset and liability items: |
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
||||||
Decrease (increase) in prepaid expenses, other current assets and other assets |
|
|
(458 |
) |
|
|
409 |
|
|
|
(150 |
) |
Increase (decrease) in trade payables |
|
|
1,934 |
|
|
|
(844 |
) |
|
|
(821 |
) |
Increase (decrease) in accrued expenses and other payables |
|
|
(3,096 |
) |
|
|
21 |
|
|
|
2,807 |
|
|
|
|
(1,620 |
) |
|
|
(414 |
) |
|
|
1,836 |
|
|
|
|
|
|
|
|
||||||
Cash received during the period for: |
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
||||||
Interest received |
|
|
348 |
|
|
|
521 |
|
|
|
1,546 |
|
Interest paid |
|
|
(47 |
) |
|
|
(28 |
) |
|
|
(134 |
) |
Net cash used in operating activities |
|
|
(12,326 |
) |
|
|
(9,450 |
) |
|
|
(37,930 |
) |
|
|
|
|
|
|
|
||||||
Cash flows from investing activities: |
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
||||||
Purchase of property, plant and equipment |
|
|
(2,119 |
) |
|
|
(350 |
) |
|
|
(3,055 |
) |
Purchase of marketable securities |
|
|
- |
|
|
|
- |
|
|
|
(32,021 |
) |
Proceeds from maturity of marketable securities |
|
|
- |
|
|
|
- |
|
|
|
38,742 |
|
Proceeds from sale of marketable securities |
|
|
13,551 |
|
|
|
13,893 |
|
|
|
- |
|
|
|
|
|
|
|
|
||||||
Net cash provided by investing activities |
|
$ |
11,432 |
|
|
$ |
13,543 |
|
|
$ |
3,666 |
|
CONSOLIDATED STATEMENTS OF CASH FLOWS |
||||||||||||
U.S. dollars in thousands |
||||||||||||
|
|
Three months ended
|
|
Year ended
|
||||||||
|
|
2020 |
|
2019 |
|
2019 |
||||||
|
|
|
|
|
|
|
||||||
Cash flows from financing activities: |
|
|
|
|
|
|
||||||
|
|
|
|
|
|
|
||||||
Proceeds from secondary offering, net |
|
|
- |
|
|
|
- |
|
|
|
37,140 |
|
Receipt of grants from the IIA |
|
|
53 |
|
|
|
- |
|
|
|
224 |
|
Proceeds from issuance of shares, initial public offering (payment of issuance expenses), net |
|
|
- |
|
|
|
(238 |
) |
|
|
(238 |
) |
Payment of lease liabilities |
|
|
(787 |
) |
|
|
(440 |
) |
|
|
(1,529 |
) |
Exercise of options |
|
|
6 |
|
|
|
- |
|
|
|
132 |
|
|
|
|
|
|
|
|
||||||
Net cash (used in) provided by financing activities |
|
|
(728 |
) |
|
|
(678 |
) |
|
|
35,729 |
|
|
|
|
|
|
|
|
||||||
Exchange differences on balances of cash and cash equivalents |
|
|
76 |
|
|
|
62 |
|
|
|
101 |
|
|
|
|
|
|
|
|
||||||
Increase in cash and cash equivalents |
|
|
1,546 |
|
|
|
3,477 |
|
|
|
1,566 |
|
Cash and cash equivalents at beginning of period |
|
|
41,838 |
|
|
|
40,272 |
|
|
|
40,272 |
|
|
|
|
|
|
|
|
||||||
Cash and cash equivalents at end of period |
|
$ |
40,292 |
|
|
$ |
43,749 |
|
|
$ |
41,838 |
|
|
|
|
|
|
|
|
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