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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 |
- Received FDA acceptance of BLA for omidubicel with Priority Review; PDUFA target action date set for January 30, 2023 -
- Dosed first patient in company-sponsored Phase 1/2 study of cryopreserved formulation of GDA-201 for the treatment of follicular and diffuse large B-cell lymphomas -
- Finished second quarter of 2022 with $55.1 million in cash;
sufficient funding for the company’s operations into mid-2023, excluding the cost of commercializing omidubicel -
- 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 June 30, 2022. Net loss for the second quarter of 2022 was $18.6 million, compared to a net loss of $23.6 million in the second quarter of 2021. As of June 30, 2022, Gamida Cell had total cash, cash equivalents and investments of $55.1 million.
Recently, Gamida Cell:
“2022 is a potentially transformative year for Gamida Cell as we continue to execute against our clinical and regulatory milestones. We were excited that the FDA accepted our BLA submission with priority review, and 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. We believe that omidubicel has the potential to change the outlook for patients suffering from blood cancers through improved outcomes, quality of life and increased access for patients who are currently eligible for transplant, but cannot find a match,” said Julian Adams, Ph.D., chief executive officer of Gamida Cell. “In addition, the development of our NAM-enabled NK cell therapy candidate, GDA-201, creates an opportunity to potentially bring a new treatment option to tens of thousands of patients with relapsed/refractory lymphoma worldwide. We continue to execute our mission of advancing our broad pipeline of NAM-enabled cell therapies with a curative approach for patients with solid tumors and blood cancers and other serious blood diseases.”
Second Quarter and Recent Developments
Omidubicel: Advanced Cell Therapy
GDA-201: NAM-Enabled NK Cell Therapy
NAM-Enabled NK Cell Pipeline Expansion
Corporate Updates
Second Quarter 2022 Financial Results
2022 Financial Guidance
Gamida Cell expects that its current cash, cash equivalents and investments will support the company’s ongoing operating activities into mid 2023, excluding the cost of commercializing omidubicel. If we decide to market omidubicel ourselves, we will require substantial additional funding. 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 2022 and Early 2023
Omidubicel
NK cell pipeline expansion
Conference Call Information
Gamida Cell will host a conference call today, August 15, 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 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.
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 NAM Technology
Our NAM-enabling technology, supported by positive omidubicel Phase 3 results, 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 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, pre-clinical and clinical trials of Gamida Cell’s product candidates (including omidubicel and GDA-201), anticipated regulatory filings (including the timing of review of the BLA for omidubicel by the FDA), commercialization planning efforts, the potentially life-saving or curative therapeutic and commercial potential of Gamida Cell’s product candidates (including GDA-201 and omidubicel), Gamida Cell’s expectations for the clinical development milestones set forth herein, and Gamida Cell’s expectations regarding its projected cash, cash equivalents and investments to be used for operating activities. 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, including the scope, progress and expansion of Gamida Cell’s clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics; and 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 May 12, 2022, 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)
June 30,
December 31,
2022
2021
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
37,890
$
55,892
Marketable securities
17,172
40,034
Prepaid expenses and other current assets
2,294
2,688
Total current assets
57,356
98,614
NON-CURRENT ASSETS:
Restricted deposits
3,591
3,961
Property, plant and equipment, net
37,967
35,180
Operating lease right-of-use assets
6,107
7,236
Severance pay fund
1,579
2,148
Other long-term assets
1,421
1,647
Total non-current assets
50,665
50,172
Total assets
$
108,021
$
148,786
LIABILITIES AND EQUITY
CURRENT LIABILITIES:
Trade payables
$
2,738
$
8,272
Employees and payroll accruals
4,978
4,957
Operating lease liabilities
2,517
2,699
Accrued interest of convertible senior notes
1,652
1,640
Accrued expenses and other current liabilities
10,412
7,865
Total current liabilities
22,297
25,433
NON-CURRENT LIABILITIES:
Convertible senior notes, net
71,801
71,417
Accrued severance pay
1,840
2,396
Long-term operating lease liabilities
4,233
5,603
Total non-current liabilities
77,874
79,416
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Share capital -
169
169
Additional paid-in capital
383,915
381,225
Accumulated deficit
(376,234
)
(337,457
)
Total shareholders’ equity
7,850
43,937
Total liabilities and shareholders’ equity
$
108,021
$
148,786
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
Three months ended June 30,
Six months ended June 30,
2022
2021
2022
2021
Unaudited
Research and development expenses, net
$
10,563
$
13,350
$
21,868
$
24,710
Commercial expenses
3,193
4,988
7,072
9,219
General and administrative expenses
4,290
3,874
8,429
7,387
Total operating loss
18,046
22,212
37,369
41,316
Financial expenses, net
508
1,345
1,408
1,427
Loss
$
18,554
$
23,557
$
38,777
$
42,743
Net loss per share, basic and diluted
0.31
0.40
0.65
0.72
Weighted average number of shares
59,546,273
59,253,315
59,510,918
59,188,504
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands (except share and per share data)
Six months ended June 30,
2022
2021
Cash flows from operating activities:
Loss
$
(38,777
)
$
(42,743
)
Adjustments to reconcile loss to net cash used in operating activities:
Depreciation of property, plant and equipment
224
206
Financing expense (income), net
(273
)
1,694
Share-based compensation
2,530
2,025
Amortization of issuance costs
385
269
Operating lease right-of-use assets
1,226
1,032
Operating lease liabilities
(1,649
)
(1,187
)
Accrued severance pay, net
14
-
Increase in prepaid expenses and other assets
(19
)
(358
)
Decrease in trade payables
(5,535
)
(884
)
Increase (decrease) in accrued expenses and current liabilities
2,285
(622
)
Net cash used in operating activities
(39,589
)
(40,568
)
Cash flows from investing activities:
Purchase of property, plant and equipment
(1,540
)
(6,118
)
Purchase of marketable securities
(3,708
)
(68,151
)
Proceeds from maturity of marketable securities
26,175
17,824
Proceeds (investments) from restricted deposits
500
(1,000
)
Net cash provided by (used in) investing activities
$
21,427
$
(57,445
)
Cash flows from financing activities:
Proceeds from exercise of options
$
76
$
556
Proceeds from share issuance, net
84
-
Proceeds from issuance of convertible senior notes, net
-
70,777
Net cash provided by financing activities
160
71,333
Decrease in cash and cash equivalents
(18,002
)
(26,680
)
Cash and cash equivalents at beginning of period
55,892
127,170
Cash and cash equivalents at end of period
$
37,890
$
100,490
Significant non-cash transactions:
Purchase of property, plant and equipment on credit
282
1,563
Supplemental disclosures of cash flow information:
Cash paid for interest
$
(2,203
)
$
-
View source version on businesswire.com: https://www.businesswire.com/news/home/20220815005184/en/
For investors: Courtney Turiano Stern Investor Relations, Inc. Courtney.Turiano@sternir.com 1-212-362-1200
For media: Heather DiVecchia Chief of Staff Heather@gamida-cell.com 1-617-892-9083
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