Gamida Cell Reports First Quarter 2022 Financial Results and Provides Company Update
Gamida Cell Ltd. (Nasdaq: GMDA) announced key updates and Q1 2022 results. The company is set to submit a full Biologics License Application (BLA) for omidubicel in Q2 2022 and plans to commence a Phase 1/2 study for GDA-201 targeting lymphomas. As of March 31, 2022, it reported $69.7 million in cash, sufficient to support operations into mid-2023. The net loss for the quarter was $20.2 million, a slight increase from $19.2 million year-on-year. Gamida Cell also presented promising data on its NK cell therapy candidates at recent conferences.
- On track for full BLA submission of omidubicel in Q2 2022.
- Cleared IND application for GDA-201, allowing Phase 1/2 study to start.
- $69.7 million cash on hand sufficient to fund operations into mid-2023.
- Net loss increased to $20.2 million from $19.2 million year-on-year.
- R&D expenses remained high at $11.3 million despite a decrease in clinical study activities.
- On track for full BLA submission of omidubicel in the second quarter of 2022 -
- Planning to open sites for enrollment in second quarter of 2022 for Phase 1/2 study of GDA-201 in patients with follicular and diffuse large B-cell lymphomas -
- Presented new preclinical data supporting potential of NAM-enabled, genetically modified NK pipeline cell therapy candidates GDA-301 and GDA-601 -
- Finished first quarter of 2022 with approximately
- Company to host conference call at
During the past quarter,
-
Progressed omidubicel, a potentially life-saving cell therapy candidate for patients with blood cancers in need of stem cell transplant, towards full Biologics License Application (BLA) submission to the
U.S. Food and Drug Administration (FDA) in the second quarter of this year. -
Planning to open sites for enrollment in second quarter of 2022 for Phase 1/2 study of lead natural killer (NK) cell therapy candidate, GDA-201, for patients with follicular and diffuse large B-cell lymphomas. The FDA recently cleared the company’s Investigational New Drug (IND) application and removed the clinical hold on the program, allowing
Gamida Cell to move forward with the planned Phase 1/2 study with the cryopreserved formulation. - Continued development of the company’s NAM-enabled NK cell pipeline, including genetically modified product candidates GDA-301, GDA-401, GDA-501 and GDA-601, which focus on solid-tumor and hematological cancers. These product candidates utilize CAR, membrane bound- and CRISPR-mediated technologies to increase the NK cell targeting, potency and persistence against hematologic malignancies and solid tumors.
“We have made significant strides advancing our pipeline and demonstrating the potential benefit of our NAM-enabled cell therapy candidates for patients with blood cancers and other serious blood,” said
First Quarter and Recent Developments
Omidubicel: Advanced Cell Therapy
-
BLA submission: Following the receipt of positive Type B meeting correspondence from the FDA confirming that analytical comparability has been established between product made at Gamida Cell’s wholly-owned commercial manufacturing facility and the product that was manufactured for the Phase 3 study,
Gamida Cell initiated a rolling BLA submission for omidubicel inFebruary 2022 . The company is on-track to complete the BLA submission in the second quarter of 2022. In parallel with the BLA submission,Gamida Cell is assessing alternatives for the commercialization of omidubicel, including potentialU.S. or global partnerships. -
New data presented at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT): In
April 2022 ,Gamida Cell announced two oral and six poster presentations that focused on omidubicel’s positive Phase 3 clinical data, Gamida Cell’s health economic efforts, and transcriptional and metabolic profiling for our lead NK candidate, GDA-201. These presentations continued to add to the totality of evidence supporting omidubicel as a potential allogeneic hematopoietic stem cell transplant and our developments with our NK candidates. Highlights from these presentations included:-
A presentation which received TCT’s Best Abstract Award entitled “Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Enhanced Circulatory Plasmacytoid Dendritic Cells (pDC), NK Cells and CD4+ T Cells with
Lower Rates of Severe Infections Compared to Standard Umbilical Cord Blood Transplantation.” This presentation detailed that Allo-HSCT with omidubicel demonstrated rapid hematopoietic recovery, reduced rates of infections and no increase in acute or chronic GvHD rates compared with standard UCB, with no unexpected adverse events attributable to ex vivo expansion. -
An oral presentation titled “Allogeneic Hematopoietic Stem Cell (allo-HSCT) Transplant with Omidubicel Demonstrates Sustained Clinical Improvement Versus Standard Myeloablative Umbilical Cord Blood Transplantation (UCBT): Final Results of a Phase III Randomized, Multicenter Study.” The data showed that the advantages of early engraftment and lower infections with omidubicel translated into long term clinical benefits in the first-year post-transplant, as demonstrated by reduction in non-relapse mortality, and no increase in relapse or GvHD rate compared to Umbilical Cord Blood Transplantation (UCBT). Additionally, there was a continued trend toward improved OS in favor of the omidubicel arm over time (
73% vs60% ). - A health economic study titled “Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant (allo-HCT) Access and Outcomes for Patients with Hematologic Malignancies in the US.” The study, which assessed the projected impact of omidubicel on racial and ethnic health disparities in a projection model, showed that, if approved, broad access to omidubicel was projected to decrease time to allo-HCT and improve allo-HCT outcomes overall, with the greatest improvements among racial and ethnic groups least served by current graft sources.
-
A presentation which received TCT’s Best Abstract Award entitled “Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel is Associated with Enhanced Circulatory Plasmacytoid Dendritic Cells (pDC), NK Cells and CD4+ T Cells with
GDA-201: NAM-Enabled NK Cell Therapy
-
IND cleared and clinical hold removed for Phase 1/2 Study with cryopreserved formulation of GDA-201:
Gamida Cell recently announced that FDA cleared its IND application and removed the clinical hold for a cryopreserved formulation of GDA-201. The company is now proceeding with operational activities at several clinical trial sites, and is on track to initiate a company-sponsored Phase 1/2 clinical study in patients with follicular and diffuse large B-cell lymphomas in 2022.
NAM-Enabled NK Cell Pipeline Expansion
-
Progressed NAM-enabled genetically modified NK pipeline:
Gamida Cell continues to progress its NAM-enabled genetically modified NK pipeline, which utilizes CAR, membrane bound- and CRISPR-mediated technologies to increase targeting, potency and persistence against hematologic malignancies and solid tumors. The company plans to conduct preclinical proof of concept studies for these genetically modified NK therapeutic targets and to select a product candidate for IND enabling studies by the end of 2022. These therapeutic targets include:- GDA-301: Knockout of CISH (cytokine inducible SH2 containing protein) in NK cells using CRISPR/Cas9 in combination with a membrane-bound IL-15/IL-15Ra;
- GDA-401: A development candidate with an undisclosed target.
- GDA-501: Anti HER2 CAR-engineered NK cells to target solid tumors expressing HER2, based on a single-chain variable fragment of the widely used humanized monoclonal antibody trastuzumab; and
-
GDA-601: CRISPR Knockout of CD38 on NK cells combined with anti CD38 CAR. CD38 is an established immunotherapeutic target in multiple myeloma, but its expression on NK cells and its further induction during ex vivo NK cell expansion represents a barrier to the development of an anti CD38 CAR-NK cell therapy.
Gamida Cell is advancing this program in collaboration with theDana-Farber Cancer Institute to study the in vitro cytotoxicity of GDA-601 in fresh samples from multiple myeloma patients.
-
Presented preclinical data from product candidates at the
International Society for Cell & Gene Therapy (ISCT) 2022:Gamida Cell recently presented new preclinical data for GDA-301 and GDA-601 that continued to demonstrate the potential of these product candidates:- A poster titled “GDA-301: Engineered NAM-NK Cells via CISH Knockout and Membrane-Bound IL-15 Expression Increases Cytotoxicity Against Malignancies,” detailed that GDA-301 produces enhanced potency and persistence with combined genetic manipulation of CISH gene editing and the engineered expression of membrane-bound IL-15 for targeting hematologic malignancies and solid tumors.
- In a poster titled “GDA-601: NAM-NK Cells With CD38 Knockout Expresses Enhanced CD38 Chimeric Antigen Receptor and Targets Multiple Myeloma Cells With Increased Cytotoxicity,” it was shown that GDA-601 displays superior antitumoral responses against multiple myeloma cells and represents a promising adoptive cell therapeutic strategy.
First Quarter 2022 Financial Results
-
Research and development expenses were
in the first quarter of 2022, compared to$11.3 million in the same quarter in 2021. The decrease was primarily due to a$11.4 million decrease in omidubicel and GDA 201 clinical study activities, offset by an increase of$1.1 million in broadening the company’s scientific capabilities and talent.$1.0 million -
Commercial expenses were
in the first quarter of 2022, compared to$3.9 million in the first quarter of 2021. The decrease was attributable mainly to reducing the company’s near-term commercial readiness expenses, as it is assessing alternatives for the commercialization of omidubicel, including potential$4.2 million U.S. or global partnerships. -
General and administrative expenses were
in the first quarter of 2022, compared to$4.1 million in the same period in 2021. The increase was mainly due to a$3.5 million increase in headcount and related expenses.$0.5 million -
Finance expenses, net, were
in the first quarter of 2022, compared to$0.9 million in the same period in 2021. The increase was primarily due to a$0.1 million increase in interest expenses from convertible notes.$0.6 million -
Net loss was
in the first quarter of 2022, compared to a net loss of$20.2 million in the first quarter of 2021.$19.2 million
2022 Financial Guidance
Expected Milestones in 2022
Omidubicel
- Completion of full BLA submission to the FDA in the second quarter of 2022
GDA-201
- Initiation of a company-sponsored Phase 1/2 clinical study with the cryopreserved formulation in follicular and diffuse large B-cell lymphomas
NK cell pipeline expansion
- Conduct preclinical proof of concept studies of the NAM-enabled, genetically modified NK therapeutic targets
- Select pipeline candidate for IND-enabling studies
Conference Call Information
About Omidubicel
Omidubicel is an advanced cell therapy candidate under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the
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
For more information about GDA-201, please visit https://www.gamida-cell.com. For more information on the Phase 1/2 clinical trial 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 NAM Technology
Our NAM-enabling technology, supported by positive Phase 3 data, is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (Nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.
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 (including GDA-201), anticipated regulatory filings (including the timing of submission of the BLA for omidubicel to the FDA), commercialization planning efforts, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including GDA-201 and omidubicel), and Gamida Cell’s expectations for the expected clinical development milestones set forth herein. Any statement describing Gamida Cell’s goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to the impact that the COVID-19 pandemic could have on our business, and including the scope, progress and expansion of Gamida Cell’s clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such product candidates. 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 10-K, filed with the
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) |
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2022 |
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2021 |
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ASSETS |
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||
|
|
|
|
|
||
CURRENT ASSETS: |
|
|
|
|
||
Cash and cash equivalents |
|
$ |
42,057 |
|
$ |
55,892 |
Marketable securities |
|
|
27,661 |
|
|
40,034 |
Prepaid expenses and other current assets |
|
|
2,994 |
|
|
2,688 |
|
|
|
|
|
||
Total current assets |
|
|
72,712 |
|
|
98,614 |
|
|
|
|
|
||
NON-CURRENT ASSETS: |
|
|
|
|
||
Restricted deposits |
|
|
3,893 |
|
|
3,961 |
Property, plant and equipment, net |
|
|
37,533 |
|
|
35,180 |
Operating lease right-of-use assets |
|
|
6,722 |
|
|
7,236 |
Severance pay fund |
|
|
2,046 |
|
|
2,148 |
Other long-term assets |
|
|
1,632 |
|
|
1,647 |
|
|
|
|
|
||
Total non-current assets |
|
|
51,826 |
|
|
50,172 |
|
|
|
|
|
||
Total assets |
|
$ |
124,538 |
|
$ |
148,786 |
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) |
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|
|
|
|
|
||
|
|
|
2022 |
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|
2021 |
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LIABILITIES AND SHARHOLDERS' EQUITY |
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CURRENT LIABILITIES: |
|
|
|
|
||
Trade payables |
|
$ |
4,346 |
|
$ |
8,272 |
Employees and payroll accruals |
|
|
4,119 |
|
|
4,957 |
Operating lease liabilities |
|
|
2,596 |
|
|
2,699 |
Accrued interest of convertible senior notes |
|
|
551 |
|
|
1,640 |
Accrued expenses and other current liabilities |
|
|
8,866 |
|
|
7,865 |
|
|
|
|
|
||
Total current liabilities |
|
|
20,478 |
|
|
25,433 |
|
|
|
|
|
||
NON-CURRENT LIABILITIES: |
|
|
|
|
||
Convertible senior notes, net |
|
|
71,607 |
|
|
71,417 |
Accrued severance pay |
|
|
2,327 |
|
|
2,396 |
Long-term operating lease liabilities |
|
|
5,142 |
|
|
5,603 |
|
|
|
|
|
||
Total non-current liabilities |
|
|
79,076 |
|
|
79,416 |
|
|
|
|
|
||
CONTINGENT LIABILITIES AND COMMITMENTS |
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SHAREHOLDERS' EQUITY: |
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Share capital - |
|
|
169 |
|
|
169 |
|
|
* |
|
|
- |
|
Additional paid-in capital |
|
|
382,495 |
|
|
381,225 |
Accumulated deficit |
|
|
(357,680) |
|
|
(337,457) |
|
|
|
|
|
||
Total shareholders' equity |
|
|
24,984 |
|
|
43,937 |
|
|
|
|
|
||
Total liabilities and shareholders' equity |
|
$ |
124,538 |
|
$ |
148,786 |
* Represents an amount lower than |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) |
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Three months ended
|
||||
|
|
|
2022 |
|
|
2021 |
|
|
|
|
|
||
Research and development expenses, net |
|
$ |
11,305 |
|
$ |
11,360 |
Commercial expenses |
|
|
3,879 |
|
|
4,231 |
General and administrative expenses |
|
|
4,139 |
|
|
3,513 |
|
|
|
|
|
||
Total operating loss |
|
|
19,323 |
|
|
19,104 |
|
|
|
|
|
||
Financial expenses, net |
|
|
900 |
|
|
82 |
|
|
|
|
|
||
Loss |
|
|
20,223 |
|
|
19,186 |
|
|
|
|
|
||
Net loss per share attributable to ordinary shareholders, basic and diluted |
|
$ |
0.34 |
|
$ |
0.32 |
|
|
|
|
|
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Weighted average number of shares used in computing net loss per share
|
|
|
59,474,366 |
|
|
59,122,973 |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) |
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|
Three months ended
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|
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2022 |
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|
2021 |
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Cash flows from operating activities: |
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|
|
|
|
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Loss |
|
$ |
(20,223) |
|
$ |
(19,186) |
Adjustments to reconcile loss to net cash used in operating activities: |
|
|
|
|
||
|
|
|
|
|
||
Depreciation of property, plant and equipment |
|
|
112 |
|
|
98 |
Financing expense (income), net |
|
|
(1,172) |
|
|
220 |
Share-based compensation |
|
|
1,194 |
|
|
913 |
Amortization of issuance costs |
|
|
191 |
|
|
323 |
Operating lease right-of-use assets |
|
|
562 |
|
|
516 |
Operating lease liabilities |
|
|
(613) |
|
|
(929) |
Accrued severance pay, net |
|
|
33 |
|
|
- |
Increase in prepaid expenses and other assets |
|
|
(889) |
|
|
(515) |
Increase (decrease) in trade payables |
|
|
(3,927) |
|
|
907 |
Decrease in accrued expenses and current liabilities |
|
|
(996) |
|
|
(3,192) |
|
|
|
|
|
||
Net cash used in operating activities |
|
|
(25,728) |
|
|
(20,845) |
|
|
|
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|
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Cash flows from investing activities: |
|
|
|
|
||
|
|
|
|
|
||
Purchase of property, plant and equipment |
|
|
(723) |
|
|
(2,806) |
Purchase of marketable securities |
|
|
(2,086) |
|
|
- |
Proceeds from maturity of marketable securities |
|
|
14,126 |
|
|
- |
Proceeds from restricted deposits |
|
|
500 |
|
|
- |
|
|
|
|
|
||
Net cash provided by (used in) investing activities |
|
$ |
11,817 |
|
$ |
(2,806) |
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
Proceeds from exercise of options |
|
76 |
|
502 |
Proceeds from issuance of convertible senior notes, net |
|
- |
|
70,777 |
|
|
|
|
|
Net cash provided by financing activities |
|
76 |
|
71,279 |
|
|
|
|
|
Increase (decrease) in cash and cash equivalents |
|
(13,835) |
|
47,628 |
Cash and cash equivalents at beginning of period |
|
55,892 |
|
127,170 |
|
|
|
|
|
Cash and cash equivalents at end of period |
|
|
|
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20220510005438/en/
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Source:
FAQ
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