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Share Name | Share Symbol | Market | Type |
---|---|---|---|
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 | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 0.0327 | 0.0302 | 0.0304 | 0 | 01:00:00 |
– Commercial launch preparations underway ahead of January 30, 2023 PDUFA target action date –
– New data presented across multiple medical meetings to support the potential of omidubicel as an advanced cell therapy, including long term follow-up data from the Phase 3 study, a real-world analysis of donor sources, and health-related quality of life scores and the potential for omidubicel to increase access to transplant for patients –
– Appointed Abigail Jenkins as President and CEO as part of planned succession –
– Strengthened financial position with sale of ordinary shares for gross proceeds of $20 million and signed a commitment letter for $25 million senior secured convertible term loan, both in September 2022 –
– Company to host conference call at 8:00 a.m. ET today –
Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today provided a business update and reported financial results for the quarter ended September 30, 2022. Net loss for the third quarter of 2022 was $17.8 million, compared to a net loss of $23.2 million in the third quarter of 2021. As of September 30, 2022, Gamida Cell had total cash, cash equivalents and investments of $61.3 million.
Recently, Gamida Cell:
Third Quarter and Recent Developments
Omidubicel: Advanced Cell Therapy Candidate
GDA-201: NAM-Enabled NK Cell Therapy
NAM-Enabled NK Cell Pipeline Development
Corporate Updates
Third Quarter 2022 Financial Results
2022 Financial Guidance
Gamida Cell expects that its current total cash position, together with recent financing, will support the company’s ongoing operating activities into mid-2023, excluding the cost of commercializing omidubicel beyond the initial launch. This cash runaway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken. Gamida Cell continues to assess all financing options that support its corporate strategy.
Expected Milestones in 2023
Omidubicel
Conference Call Information
Gamida Cell will host a conference call today, November 14, 2022, at 8:00 a.m. ET to discuss these financial results and company updates. To access the conference call, please register here and be advised to do so at least 10 minutes prior to joining the call. A live webcast of the conference call can be accessed in the “Investors & Media” section of Gamida Cell’s website at www.gamida-cell.com. A replay of the webcast will be available approximately two hours after the event, for approximately 30 days.
About NAM Technology Our NAM-enabling technology 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 Omidubicel Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) 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 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 US and EU.
The BLA for omidubicel has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023. If approved, omidubicel will be the first allogeneic advanced stem cell therapy donor source for patients with blood cancers in need of a stem cell transplant.
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 Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the potential treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical study data. 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. There are approximately 40,000 patients with relapsed/refractory lymphoma in the US and EU, which is the patient population that will be studied in the currently ongoing GDA-201 Phase 1/2 clinical trial.
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 cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
About Gamida Cell Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK cells to create therapy candidates with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies. For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.
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 omidubicel and GDA-201), regulatory filings submitted to the FDA (including the potential timing of the FDA’s review of the BLA for omidubicel), commercialization planning efforts and launch activities, the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including omidubicel and GDA-201), progress on the preclinical NAM-enabled NK cell pipeline, and Gamida Cell’s expectations regarding its projected cash to be used for operating activities and 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 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 Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission (SEC) on August 15, 2022, as amended, 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. Although Gamida Cell’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
September 30,
December 31,
2022
2021
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
55,071
$
55,892
Marketable securities
6,224
40,034
Prepaid expenses and other current assets
1,408
2,688
Total current assets
62,703
98,614
NON-CURRENT ASSETS:
Restricted deposits
3,556
3,961
Property, plant and equipment, net
39,940
35,180
Operating lease right-of-use assets
5,459
7,236
Severance pay fund
1,595
2,148
Other long-term assets
1,059
1,647
Total non-current assets
51,609
50,172
Total assets
$
114,312
$
148,786
September 30,
December 31,
2022
2021
LIABILITIES AND SHARHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables
$
1,916
$
8,272
Employees and payroll accruals
5,689
4,957
Operating lease liabilities
1,880
2,699
Accrued interest of convertible senior notes
551
1,640
Accrued expenses and other current liabilities
12,677
7,865
Total current liabilities
22,713
25,433
NON-CURRENT LIABILITIES:
Convertible senior notes, net
71,999
71,417
Accrued severance pay
1,865
2,396
Long-term operating lease liabilities
4,174
5,603
Total non-current liabilities
78,038
79,416
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS' EQUITY:
Share capital
210
169
Additional paid-in capital
407,387
381,225
Accumulated deficit
(394,036
)
(337,457
)
Total shareholders' equity
13,561
43,937
Total liabilities and shareholders' equity
$
114,312
$
148,786
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
Three months ended
September 30,
Nine months ended
September 30,
2022
2021
2022
2021
(unaudited)
(unaudited)
Research and development expenses, net
$
9,864
$
11,725
$
31,732
$
36,435
Commercial expenses
2,760
5,755
9,832
14,974
General and administrative expenses
4,437
5,001
12,866
12,388
Total operating loss
17,061
22,481
54,430
63,797
Financial expenses, net
741
692
2,149
2,119
Loss
$
17,802
$
23,173
$
56,579
$
65,916
Net loss per share attributable to ordinary shareholders, basic and diluted
0.29
0.39
0.95
1.11
Weighted average number of shares used in computing net loss per share attributable to ordinary shareholders, basic and diluted
60,440,765
59,281,243
59,821,655
59,219,757
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands (except share and per share data)
Nine months ended
September 30,
2022
2021
Cash flows from operating activities:
Loss
$
(56,579
)
$
(65,916
)
Adjustments to reconcile loss to net cash used in operating activities:
Depreciation of property, plant and equipment
391
317
Financing expense (income), net
(2,461
)
89
Share-based compensation
3,829
3,122
Amortization of debt discount and issuance costs
582
453
Operating lease right-of-use assets
1,922
1,542
Operating lease liabilities
(2,395
)
(1,764
)
Accrued severance pay, net
23
-
Decrease in prepaid expenses and other assets
1,719
558
Increase (decrease) in trade payables
(6,355
)
1,533
Increase (decrease) in accrued expenses and current liabilities
5,079
(1,361
)
Net cash used in operating activities
(54,245
)
(61,427
)
Cash flows from investing activities:
Purchase of property, plant and equipment
(2,865
)
(9,577
)
Purchase of marketable securities
(4,557
)
(97,808
)
Proceeds from maturity of marketable securities
37,972
56,717
Proceeds (investments) from restricted deposits
500
(5,803
)
Net cash provided by (used in) investing activities
$
31,050
$
(56,471
)
Cash flows from financing activities:
Proceeds from exercise of options
$
76
$
566
Proceeds from share issuance, net
22,298
-
Proceeds from issuance of convertible senior notes, net
-
70,777
Net cash provided by financing activities
22,374
71,343
Decrease in cash and cash equivalents
(821
)
(46,555
)
Cash and cash equivalents at beginning of period
55,892
127,170
Cash and cash equivalents at end of period
$
55,071
$
80,615
Significant non-cash transactions:
Purchase of property, plant and equipment on credit
281
1,561
Supplemental disclosures of cash flow information:
Cash paid for interest
$
(4,406
)
$
(2,191
)
View source version on businesswire.com: https://www.businesswire.com/news/home/20221114005403/en/
For investors: Courtney Turiano Stern Investor Relations, Inc. Courtney.Turiano@sternir.com 1-212-362-1200
For media: Heather DiVecchia Director, Investor Relations and Corporate Communications Heather@gamida-cell.com 1-617-892-9083
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