BOSTON--(BUSINESS WIRE)--Mar 27, 2023--
Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today provided a business update and reported financial results for the year ended December 31, 2022. Net loss for 2022 was $79.4 million, compared to a net loss of $89.8 million in 2021. As of December 31, 2022, Gamida Cell had total cash and cash equivalents of $64.7 million.
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 May 1, 2023 target Prescription Drug User Fee Act (PDUFA) action date. The company also announced a strategic restructuring of its operations to prioritize launch of omidubicel to ensure that, if approved, patients who may potentially benefit will have access to therapy. To reduce expenses, the company will discontinue development of its preclinical NK cell therapy candidates while continuing to enroll patients in the GDA-201 Phase 1 clinical trial.
“Our mission is to bring potentially curative therapies to patients,” said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell. “We believe we have a clear path to approval and are preparing for the commercial launch of omidubicel, if approved. Given the challenging economic environment, to date, we have not been able to raise adequate funding to support our full pipeline and enable a more robust launch of omidubicel, if approved. As a result, we are taking decisive actions to do three things 1) prioritize resources toward the launch 2) reduce expenses across the board 3) seek potential commercial or strategic partnerships to maximize patient access to omidubicel, a potentially life-saving therapy. Today’s actions are difficult. Especially since our engineered NK cell therapy candidates, which are derived from healthy donors, have demonstrated encouraging pre-clinical data that differentiate them from other NK cell therapy approaches. The science is promising, but these changes are economically necessary to ensure omidubicel reaches as many patients as possible.”
Today Gamida Cell announced it would:
Fourth Quarter and Recent Developments
Omidubicel: Advanced Cell Therapy
GDA-201: Intrinsic NK Cell Therapy
Corporate Developments
Full Year 2022 Financial Results
2023 Financial Guidance
Gamida Cell expects its current cash and cash equivalents will support the company’s ongoing operating activities through the third quarter of 2023. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding and any business development activities that may be undertaken.
Conference Call Information
Gamida Cell will host a conference call today, March 27, 2023, 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 conference call webcast can be accessed in the “Investors & Media” section of Gamida Cell’s website at www.gamida-cell.com. A webcast replay will be available approximately two hours after the event for approximately 30 days.
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 U.S. and E.U. Omidubicel has a PDUFA target action date of May 1, 2023.
Omidubicelis 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 aboutomidubicel, 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 Gamida Cell
Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s research and development efforts have produced potentially curative cell therapy candidates for patients with blood cancers. The company applies a proprietary expansion platform leveraging the properties of nicotinamide to cell sources including umbilical cord blood-derived cells and NK cells to create allogeneic cell therapy candidates with the potential to redefine standards of care. These include omidubicel, an advanced cell therapy candidate for allogeneic hematopoietic stem cell transplant that, if approved, has the potential to expand access and improve outcomes for patients with blood cancers, and GDA-201, an intrinsic NK cell therapy candidate being investigated for the treatment of 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 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 Securities and Exchange Commission (SEC) on November 14, 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.
CONSOLIDATED BALANCE SHEETS | ||||||
U.S. dollars in thousands(except share and per share data) | ||||||
| December 31, | |||||
| 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 | ||||||||
U.S. dollars in thousands(except share and per share data) | ||||||||
| December 31, | |||||||
| 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 NIS 0.01 par value - Authorized: 150,000,000 shares at December 31, 2022 and 2021; Issued: 74,703,030 and 59,970,389 shares at December 31, 2022 and 2021, respectively; Outstanding: 74,583,026 and 59,970,389 shares at December 31, 2022 and 2021, respectively |
| 211 |
|
| 169 |
| ||
Treasury ordinary shares of NIS 0.01 par value; 120,004 and 0 shares at December 31, 2022 and 2021, respectively | * |
| - |
| ||||
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 $1. |
CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||
U.S. dollars in thousands (except share and per share data) | ||||||
| Year ended December 31, | |||||
| 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 | ||||||||
U.S. dollars in thousands (except share and per share data) | ||||||||
|
| Year ended December 31, | ||||||
|
| 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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CONTACT: Investor and media contact:
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Orangefiery
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KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: RESEARCH CLINICAL TRIALS HEALTH TECHNOLOGY STEM CELLS BIOTECHNOLOGY HEALTH PHARMACEUTICAL SCIENCE ONCOLOGY
SOURCE: Gamida Cell Ltd.
Copyright Business Wire 2023.
PUB: 03/27/2023 07:00 AM/DISC: 03/27/2023 07:02 AM
http://www.businesswire.com/news/home/20230324005391/en