Gamida Cell Reports Full Year 2022 Financial Results and Provides Company Update
Gamida Cell Ltd. (Nasdaq: GMDA) provided a business update highlighting productive FDA interactions and preparing for the potential launch of its lead product, omidubicel, ahead of its May 1 PDUFA date. The company reported a net loss of $79.4 million for 2022, improved from $89.8 million in 2021, with cash reserves of $64.7 million. Strategic restructuring will focus on omidubicel and reduce operating expenses, including a 17% workforce reduction. The company aims for commercial partnerships and plans to continue its GDA-201 Phase 1 study while discontinuing its NK cell preclinical candidates. Positive feedback from transplant centers and anticipated payer coverage indicate potential market success.
- Improved net loss of $79.4 million for 2022 compared to $89.8 million in 2021.
- Cash reserves of $64.7 million to support operations.
- Productive FDA interactions and positive feedback from transplant centers.
- Plans to onboard 10-15 top U.S. transplant centers in 2023.
- Anticipated payer coverage for omidubicel, facilitating potential market access.
- A 17% workforce reduction due to financial constraints.
- Discontinuation of NK cell therapy candidates, limiting future pipeline diversity.
- Dependence on cash reserves to sustain operations through Q3 2023 without additional funding.
Company reports on productive interactions with FDA and preparations for launch of omidubicel, if approved, in advance of
Company outlines strategic restructuring, plans to prioritize omidubicel launch and reduce operating expenses to extend cash runway
Company to explore strategic options to support a broader launch of omidubicel, including potential US and global partnerships with pharmaceutical companies
Company intends to continue GDA-201 Phase 1 study, discontinue development of natural killer (NK) cell preclinical candidates and consolidate its operations in
Company to host conference call at
The company highlighted positive data, productive regulatory interactions and progress on commercial readiness activities supporting its lead product candidate, omidubicel, an advanced cell therapy candidate for allogeneic stem cell transplant, as it advances toward its
“Our mission is to bring potentially curative therapies to patients,” said
Today
-
Implement a strategic restructuring to focus on omidubicel launch, if approved: The company intends to allocate the vast majority of its resources to executing a launch of omidubicel, if approved, although with a more limited investment and slower ramp than previously planned in order to manage its financial resources. The company reported productive interactions with the FDA, including a recently completed Late Cycle Meeting and a previously reported Pre-Licensing Inspection of the company’s
Kiryat Gat, Israel , manufacturing facility, with no 483 observations received to date. Recently presented data continue to support the clinical benefits and safety of omidubicel, which, if approved, may be a valuable new donor source for patients in need of allogeneic stem cell transplant. Commercial readiness activities have made progress as the company prepares to onboard approximately 10-15 of the top 70 transplant centers inthe United States in 2023. Omidubicel has received positive feedback from leading transplant centers, including ones that did not participate in the company’s clinical trials. The company has met withU.S. payers, including payers that cover more than90% of commercially covered lives, and reported that payers indicate they anticipate covering a one-time therapy with curative intent.
- Continue its GDA-201 Phase 1 study: The company will continue to enroll patients in its GDA-201 Phase 1 dose escalation study.
-
Reduce operating expenses in order to extend its cash runway: The company will discontinue the development of its engineered NK cell therapy preclinical pipeline, including GDA-301, GDA-501 and GDA-601, while maintaining the IP to these candidates. It will implement a headcount reduction of
17% , with the majority of impacted headcount tied to the discontinuation of the pre-clinical NK cell therapy candidates. The company will also close its operations inJerusalem and consolidateIsrael operations at its state-of-the-art manufacturing facility inKiryat Gat . These changes are expected to extend the company’s cash runway through Q3 2023.
- Explore strategic options: The company intends to seek potential commercial or strategic partnerships to maximize patient access to omidubicel, if approved.
Fourth Quarter and Recent Developments
Omidubicel: Advanced Cell Therapy
-
New data presented at ASH and TCT: The company presented new data characterizing peripheral blood lymphocytes measured in correlation with time to neutrophil and platelet engraftment in omidubicel-transplanted and standard cord blood-transplanted patients at the 2023 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the
American Society for Transplantation & Cellular Therapy and theCenter for International Blood and Marrow Transplant Research in February. Seven days post-transplant, omidubicel-transplanted patients showed a statistically significant correlation between CD3+/CD4+ T cell counts and time to neutrophil engraftment. Similar correlations were noted between CD3+/CD8+/CD19+ cell counts and time to platelet engraftment. Patients transplanted with standard cord blood showed no such correlations at Day 7 post-transplant, and only began to show correlations starting at 14 days post-transplant. Data support past findings that omidubicel stimulates a faster immune response than standard cord blood, which may be a contributing mechanism resulting in the lower incidence of serious bacterial, fungal and viral infections for omidubicel-transplanted patients.
-
New publication in press: The company reported a publication in press in Transplantation and Cellular Therapy, now available online, reporting on long-term follow-up of patients transplanted with omidubicel across five clinical trials. The analysis showed a three-year overall survival of
62.5% and disease-free survival of54% . With up to 10 years of follow-up, omidubicel showed durable hematopoiesis.
-
Manufacturing readiness: The company’s state-of-the-art manufacturing facility in
Kiryat Gat, Israel , is ready for commercial launch if omidubicel is approved and is currently producing omidubicel for the company’s Extended Access Program (EAP) and its ongoing omidubicel aplastic anemia study. The facility, which has completed itsIsraeli Ministry of Health andFDA pre-licensure inspections with no 483 observations to date, has the ability to deliver omidubicel back to the transplant center within approximately 30 days from the start of manufacturing.
- Commercial readiness: The company continues to advance efforts throughout the organization to prepare for the launch of omidubicel, if approved.
GDA-201: Intrinsic NK Cell Therapy
-
New data presented at Tandem Meetings: The company presented a poster at the 2023 Tandem Meetings, Transplantation & Cellular Therapy (TCT) Meetings of the
American Society for Transplantation & Cellular Therapy and theCenter for International Blood and Marrow Transplant Research reporting new preclinical data on the cryopreserved formulation of GDA-201, which showed increased potency and enhanced cytotoxicity. GDA-201 cells were tested for viability, phenotyping, function and potency. Previous characterization of GDA-201 showed high levels of CD56, CD16, CD49a and CD62L expression, low levels of CD57, and low levels of immune checkpoints such as LAG3 and CD200R. The new analyses showed that cryopreserved GDA-201 exhibited high viability (>90% ) and high purity up to 12 months post-manufacturing and preserved the ability to proliferate post-thaw. GDA-201 maintained high levels of expression of CD16, which mediates antibody-dependent cellular toxicity, and CD62L, which is a homing and retention marker. GDA-201 also demonstrated high potency, based on the intracellular secretion of TNF-alpha & IFN-gamma and extracellular degranulation marker CD107a.
In addition, external investigator Veronika Bachanova, M.D., Ph.D., Professor at theUniversity of Minnesota Medical School , gave an oral presentation highlighting novel observations of “on treatment” tumor biopsies from eight patients treated with GDA-201 in a Phase 1 study. The microscopic spatial analysis demonstrated that while GDA-201 cells were virtually undetectable in tumors after 14 days, T cells were observed in 50-95% of tumor site cellularity. Most biopsies obtained as early as three to seven days post-infusion showed strong indications of widespread tumor death. These observations suggest that GDA-201 infusions trigger profound immune microenvironment changes, supporting the influx of host T cells early post-GDA-201 infusion. These findings further suggest the engagement of the adaptive immune system and effective tumor elimination.
Corporate Developments
-
On
March 20 , the company announced thatShawn Cline Tomasello was elected Chairwoman of the Board of Directors, succeeding ChairmanRobert I. Blum , who resigned.Ms. Tomasello joined the Gamida Cell Board of Directors inJune 2019 . She has extensive experience in leading successful commercial activities at several pharmaceutical companies and providing key strategic guidance on company boards. Dr.Anat Cohen-Dayag and Dr.Naama Halevi Davidov also resigned from the company’s Board of Directors.
-
In December, the company and its wholly owned subsidiary, as borrower, closed on a senior secured convertible term loan of
with certain funds managed by$25 million Highbridge Capital Management, LLC . The loan has a maturity date ofDecember 12, 2024 .
Full Year 2022 Financial Results
-
Research and development expenses, net were
in 2022, compared to$42.7 million in 2021. The decrease was primarily due to a$50.2 million decrease in clinical and operational activities relating to the conclusion of our Phase 3 study of omidubicel, offset by an increase of$9.6 million in T&E and other expenses as well as a$1.1 million decrease in$1.0 million Israeli Innovation Authority grants. -
Commercial expenses in 2022 were
, compared to$12.9 million in 2021. The decrease was primarily due to a$20.0 million decrease in commercial launch readiness expenses, offset by an increase of$8.2 million in headcount related expenses.$1.1 million -
General and administrative expenses were
in 2022, compared to$19.4 million in 2021. The increase was mainly driven by an increase of$17.0 million attributed to our corporate headquarters and headcount-related expenses as well as a$1.4 million increase in professional services expenses.$1.0 million -
Financial expenses, net, were
for 2022, compared to$4.4 million for 2021. The increase was primarily due to expenses relating to the closing on a senior secured convertible term loan of$2.6 million with certain funds managed by$25 million Highbridge Capital Management, LLC . -
Net loss for 2022 was
, compared to$79.4 million in 2021.$89.8 million
2023 Financial Guidance
Conference Call Information
About Omidubicel
Omidubicel is an advanced cell therapy candidate for allogeneic hematopoietic stem cell (bone marrow) transplant that, if approved, has the potential to expand access and improve outcomes for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment compared to standard umbilical cord blood in an international, multicenter, randomized Phase 3 study (NCT02730299) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by a significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the
Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit https://www.gamida-cell.com.
About GDA-201
GDA-201 is an intrinsic NK cell therapy candidate being investigated for the treatment of hematologic malignancies. Preclinical studies have shown that GDA-201 may address key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, these data suggest GDA-201 may improve antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. A multicenter Phase 1/2 study of GDA-201 for the treatment of non-Hodgkin lymphoma is ongoing.
GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
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 the FDA’s review of the BLA for omidubicel, and the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including omidubicel), and the company’s anticipated cash runway. 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 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. 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 Quarterly Report on Form 10-Q, filed with the
CONSOLIDATED BALANCE SHEETS |
||||||
|
||||||
|
|
|||||
|
2022 |
2021 |
||||
ASSETS |
|
|
||||
|
|
|
||||
CURRENT ASSETS: |
|
|
||||
Cash and cash equivalents |
$ |
64,657 |
$ |
55,892 |
||
Marketable securities |
|
- |
|
40,034 |
||
Prepaid expenses and other current assets |
|
1,889 |
|
2,688 |
||
|
|
|
||||
Total current assets |
|
66,546 |
|
98,614 |
||
|
|
|
||||
NON-CURRENT ASSETS: |
|
|
||||
Restricted deposits |
|
3,668 |
|
3,961 |
||
Property, plant and equipment, net |
|
44,319 |
|
35,180 |
||
Operating lease right-of-use assets |
|
7,024 |
|
7,236 |
||
Severance pay fund |
|
1,703 |
|
2,148 |
||
Other long-term assets |
|
1,513 |
|
1,647 |
||
|
|
|
||||
Total non-current assets |
|
58,227 |
|
50,172 |
||
|
|
|
||||
Total assets |
$ |
124,773 |
$ |
148,786 |
CONSOLIDATED BALANCE SHEETS |
||||||||
|
||||||||
|
|
|||||||
|
2022 |
2021 |
||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
||||||
|
|
|
||||||
CURRENT LIABILITIES: |
|
|
||||||
Trade payables |
$ |
6,384 |
|
$ |
8,272 |
|
||
Employees and payroll accruals |
|
5,300 |
|
|
4,957 |
|
||
Operating lease liabilities |
|
2,648 |
|
|
2,699 |
|
||
Accrued interest of convertible senior notes |
|
1,652 |
|
|
1,640 |
|
||
Accrued expenses and current liabilities |
|
8,891 |
|
|
7,865 |
|
||
|
|
|
||||||
Total current liabilities |
|
24,875 |
|
|
25,433 |
|
||
|
|
|
||||||
NON-CURRENT LIABILITIES: |
|
|
||||||
Convertible senior notes, net |
|
96,450 |
|
|
71,417 |
|
||
Accrued severance pay |
|
1,914 |
|
|
2,396 |
|
||
Long-term operating lease liabilities |
|
4,867 |
|
|
5,603 |
|
||
Other long-term liabilities |
|
4,690 |
|
|
- |
|
||
|
|
|
||||||
Total non-current liabilities |
|
107,921 |
|
|
79,416 |
|
||
|
|
|
||||||
CONTINGENT LIABILITIES AND COMMITMENTS |
|
|
||||||
|
|
|
||||||
SHAREHOLDERS’ EQUITY (DEFICIT): |
|
|
||||||
Ordinary shares of
Authorized: 150,000,000 shares at |
|
211 |
|
|
169 |
|
||
|
* |
|
- |
|
||||
Additional paid-in capital |
|
408,598 |
|
|
381,225 |
|
||
Accumulated deficit |
|
(416,832 |
) |
|
(337,457 |
) |
||
|
|
|
||||||
Total shareholders’ equity (deficit) |
|
(8,023 |
) |
|
43,937 |
|
||
|
|
|
||||||
Total liabilities and shareholders’ equity |
$ |
124,773 |
|
$ |
148,786 |
|
||
* Represents an amount lower than |
CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||
|
||||||
|
Year ended
|
|||||
|
2022 |
2021 |
||||
|
|
|
||||
Research and development expenses, net |
$ |
42,692 |
$ |
50,177 |
||
Commercial expenses |
|
12,900 |
|
20,013 |
||
General and administrative expenses |
|
19,401 |
|
16,977 |
||
|
|
|
||||
Total operating loss |
|
74,993 |
|
87,167 |
||
|
|
|
||||
Financial expenses, net |
|
4,382 |
|
2,626 |
||
|
|
|
||||
Loss |
$ |
79,375 |
$ |
89,793 |
||
|
|
|
||||
Net loss per share attributable to ordinary shareholders, basic and diluted |
$ |
1.24 |
$ |
1.52 |
||
|
|
|
||||
Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, basic and diluted |
|
63,826,295 |
|
59,246,803 |
CONSOLIDATED STATEMENTS OF CASH FLOWS |
||||||||
|
||||||||
|
|
Year ended
|
||||||
|
|
2022 |
|
2021 |
||||
Cash flows from operating activities: |
|
|
|
|
||||
|
|
|
|
|
||||
Loss |
|
$ |
(79,375 |
) |
|
$ |
(89,793 |
) |
|
|
|
|
|
||||
Adjustments to reconcile loss to net cash used in operating activities: |
|
|
|
|
||||
|
|
|
|
|
||||
Depreciation of property, plant and equipment |
|
|
440 |
|
|
|
431 |
|
Financing expense (income), net |
|
|
(375 |
) |
|
|
359 |
|
Share-based compensation |
|
|
5,041 |
|
|
|
4,233 |
|
Amortization of debt discount and issuance costs |
|
|
783 |
|
|
|
638 |
|
Operating lease right-of-use assets |
|
|
2,494 |
|
|
|
2,109 |
|
Operating lease liabilities |
|
|
(3,069 |
) |
|
|
(2,193 |
) |
Decrease (increase) accrued severance pay, net |
|
|
(37 |
) |
|
|
12 |
|
Decrease in prepaid expenses and other assets |
|
|
224 |
|
|
|
1,008 |
|
Increase (decrease) in trade payables |
|
|
(1,888 |
) |
|
|
1,941 |
|
Increase (decrease) in accrued expenses and current liabilities |
|
|
5,339 |
|
|
|
(505 |
) |
|
|
|
|
|
||||
Net cash used in operating activities |
|
|
(70,423 |
) |
|
|
(81,760 |
) |
|
|
|
|
|
||||
Cash flows from investing activities: |
|
|
|
|
||||
|
|
|
|
|
||||
Purchase of property, plant and equipment |
|
|
(6,354 |
) |
|
|
(15,054 |
) |
Purchase of marketable securities |
|
|
(5,037 |
) |
|
|
(102,179 |
) |
Proceeds from maturity of marketable securities |
|
|
45,029 |
|
|
|
61,534 |
|
Investment in restricted deposits |
|
|
- |
|
|
|
(5,222 |
) |
Proceeds from restricted deposits |
|
|
406 |
|
|
|
- |
|
|
|
|
|
|
||||
Net cash provided by (used in) investing activities |
|
$ |
34,044 |
|
|
$ |
(60,921 |
) |
Cash flows from financing activities: |
|
|
||||||
|
|
|
||||||
Proceeds from exercise of options |
$ |
76 |
|
$ |
626 |
|
||
Proceeds from share issuance, net |
|
22,298 |
|
- |
|
|||
Proceeds from issuance of convertible senior notes, net |
|
22,770 |
|
|
70,777 |
|
||
|
|
|
||||||
Net cash provided by financing activities |
|
45,144 |
|
|
71,403 |
|
||
|
|
|
||||||
Increase (decrease) in cash and cash equivalents |
|
8,765 |
|
|
(71,278 |
) |
||
Cash and cash equivalents at beginning of year |
|
55,892 |
|
|
127,170 |
|
||
|
|
|
||||||
Cash and cash equivalents at end of year |
$ |
64,657 |
|
$ |
55,892 |
|
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FAQ
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