Gamida Cell Reports First Quarter 2020 Financial Results and Provides Company Update
– Primary endpoint achieved in global, randomized, Phase 3 study of omidubicel; Initiation of BLA submission planned for fourth quarter of 2020 —
– Additional data from GDA-201 program expected in second half of 2020 –
–
– Company to host conference call at
“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
“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,”
Company Highlights
-
Reported positive topline data from Phase 3 study of omidubicel: Last week,
Gamida Cell announced positive topline data from its international, randomized Phase 3 study of omidubicel. The study was designed to evaluate the safety and efficacy of omidubicel in 125 patients with high-risk hematologic malignancies undergoing a bone marrow transplant compared to a comparator group of patients who received a standard umbilical cord blood transplant. The primary endpoint was time to neutrophil engraftment.
The study achieved its primary endpoint (p<0.001). In the intent-to-treat analysis, the median time to neutrophil engraftment was significantly shorter for patients who were randomized to omidubicel (12 days; 95% CI: 10-15 days) compared to the comparator group (22 days; 95% CI: 19-25 days). Omidubicel was generally well tolerated. Among patients who were transplanted per protocol, 96 percent of patients who received omidubicel achieved successful neutrophil engraftment, compared to 88 percent of patients in the comparator group.
The study included patients aged 12–65 years with high-risk hematologic malignancies and was conducted at more than 50 clinical centers inthe United States ,Latin America ,Europe andAsia . The demographics and baseline characteristics were well-balanced across the two study groups.Gamida Cell expects to present the full Phase 3 data set at a medical meeting later this year and submit a rolling biologics license application to the FDA in the fourth quarter of 2020.
-
Announced
$60 million public offering: OnMay 18 , Gamida cell announced the pricing of an underwritten public offering of 13,333,334 ordinary shares at a public offering price of$4.50 per share for aggregate gross proceeds of approximately$60 million , before deducting underwriting discounts and commissions and estimated offering expenses. In addition,Gamida Cell granted the underwriters a 30-day option to purchase up to an additional 2,000,000 ordinary shares at the public offering price, less the underwriting discounts and commissions. The offering is expected to close today, subject to satisfaction of customary closing conditions.
-
Continued to focus on activities required to successfully bring omidubicel to patients:
Gamida Cell is continuing to advance key activities required to bring omidubicel to patients in a commercial setting, including building out manufacturing infrastructure, assembling an experienced commercial team with expertise in cell therapy and transplant, establishing hospital services and patient assistance programs, and exploring coverage and reimbursement models to enable access.
-
Published updated data for GDA-201: In
February 2020 , updated data from the ongoing Phase 1 clinical study of GDA-201 in patients with non-Hodgkin lymphoma (NHL) and multiple myeloma (MM) was reported in an abstract published in advance of the 46thEuropean Society for Blood Marrow Transplantation (EBMT) Annual Meeting, which was subsequently postponed due to COVID-19. The data from the first 25 patients demonstrated that GDA-201 was clinically active and generally well tolerated. Among the eleven patients with NHL, seven patients achieved a complete response and one patient achieved a partial response. Among the patients with MM, one patient achieved a complete response, and four patients achieved stable disease.Gamida Cell expects to provide updated data from the study at a medical conference in the second half of 2020.
-
Continued preparations for the next clinical study of GDA-201: Based on the data from the ongoing Phase 1 study of GDA-201 previously presented,
Gamida Cell expects to submit an investigational new drug application to the FDA in the fourth quarter of 2020 to enable the initiation of a multi-center Phase 1/2 clinical study in patients with NHL.
COVID-19 Operational Impact
“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.
Expected 2020-2021 Milestones
Omidubicel
- Present data from the Phase 3 study at a medical meeting in the second half of 2020
- Initiate the submission of the biologics license application to the FDA, on a rolling basis, in the fourth quarter of 2020
- Report additional data from the Phase 1/2 study in patients with severe aplastic anemia in the second half of 2020
- Launch omidubicel in 2021, contingent upon FDA approval
GDA-201
- Present additional data from the Phase 1 study in the second half of 2020
- Submit company-sponsored investigational new drug application to FDA in the fourth quarter of 2020
- Initiate a Phase 1/2 clinical study in patients with NHL in 2021
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 theIsrael 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 endedMarch 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 ofDecember 31, 2019 . TheMarch 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.
2020 Financial Guidance
Conference Call Information
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
About GDA-201
Omidubicel and GDA-201 are investigational therapies, and their safety and efficacy have not been evaluated by the
About
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
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION |
||||||||
|
||||||||
|
|
|
||||||
|
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 |
|
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 |
||||||||||||
|
||||||||||||
|
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 |
||||||||||||
|
||||||||||||
|
|
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 |
||||||||||||
|
||||||||||||
|
|
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 |
|
|
|
|
|
|
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200521005349/en/
jaren@gamida-cell.com
1-617-286-6264
mcorcoran@tenbridgecommunications.com
1-617-866-7350
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