Major transformation underway commencing withrecent acquisition
reassertingfull ownership and control over Octomera
Secured a
Enteredinto asset purchase and strategic collaboration agreement which will provide Octomera with over
“Orgenesis is a company that has set as its goal to make cell and gene therapies available and affordable. The cell and gene industry has continued to grow year over year driven by the curative potential of these groundbreaking therapies, and yet, the challenges of reducing costs of products and the ability to enable quick expansion of production capacity have not been overcome,” commented
“Unfortunately, the last year was an extremely difficult one for the industry. Although there has been widespread acceptance of the field with multiple approvals of new products, the lack of funding has hit early-stage development companies the hardest. A majority of Octomera’s customers fall into the early-stage category. Many of them are innovative companies that are developing potentially lifesaving therapies that have based their entire development on a decentralized strategy and invested millions of dollars by means of service payments to Octomera.”
“Even as we continue to engage these customers, we are taking a conservative accounting approach as to their future outlook. We remain hopeful that, as the funding environment improves, they will secure additional funding and thank them for their bedrock support in turning decentralized supply into a reality for the industry. Moreover, with new regulatory initiatives underway that align with our decentralized approach, we believe both the public and private sectors are now acutely aware of the need to address industry-wide capacity and cost constraints. Stakeholders are realizing that decentralized production is an undeniable reality, making it not only a viable option, but a critical pathway for the long-term success of this industry.”
”We are appreciative of our dedicated employees, suppliers, partners and investors who have stood by us, realizing both our potential and the significance of our achievements. With their unwavering support, we have not only survived, but are poised for growth, with major initiatives now underway that we expect will transform the Company.”
“Looking forward, our first major step in the transformation was the recent transaction to regain 100% ownership of Octomera, our strategic CGT processing subsidiary. We believe that the Octomera platform featuring the
“Leveraging our decentralized services platform, we are advancing our therapeutic pipeline with a focus on our immune-oncology portfolio while leveraging non-dilutive grants to fund a significant portion of our activities. As a recent example of the broad pipeline of grants awarded but not fully spent, an Orgenesis’ consortium was awarded two grants from the Walloon Government in
"Most notably, the grant funding accelerates the placement of a CAR-T dedicated OMPUL in
“I am encouraged by the global demand I have witnessed firsthand, coupled with our cell processing expertise and the extraordinary talent that has been assembled within the organization. We are rapidly advancing our proprietary portfolio of potential therapies, which have the potential to help make our goal of improving access and outcomes in healthcare a reality. We believe that we are now on more solid financial footing having already received collaboration payments in excess of
The complete financial results for the fourth quarter and year ended
About
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, our reliance on, and our ability to grow, our point-of-care cell therapy platform and OMPUL business, our ability to achieve and maintain overall profitability, our ability to manage our research and development programs that are based on novel technologies, our ability to control key elements relating to the development and commercialization of therapeutic product candidates with third parties, the timing of completion of clinical trials and studies, the availability of additional data, outcomes of clinical trials of our product candidates, the potential uses and benefits of our product candidates, our ability to manage potential disruptions as a result of the COVID-19 pandemic, the sufficiency of working capital to realize our business plans and our ability to raise additional capital, the development of our POCare strategy, our trans differentiation technology as therapeutic treatment for diabetes, the technology behind our in-licensed ATMPs not functioning as expected, our ability to further our CGT development projects, either directly or through our JV partner agreements, and to fulfill our obligations under such agreements, our license agreements with other institutions, our ability to retain key employees, our competitors developing better or cheaper alternatives to our products, risks relating to legal proceedings against us and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended
IR contact for
Tel: 212-671-1021
Orgs@crescendo-ir.com
Communications contact for
Tel +44 (0)20 8943 4685
neil@ibcomms.agency / michelle@ibcomms.agency
(tables follow)
CONSOLIDATED BALANCE SHEETS ( | |||||
2023 | 2022 | ||||
CURRENT ASSETS: | |||||
Cash and cash equivalents | $ | 837 | $ | 5,311 | |
Restricted cash | 642 | 1,058 | |||
Accounts receivable, net of credit losses of | 88 | 36,183 | |||
Prepaid expenses and other receivables | 2,017 | 958 | |||
Receivables from related parties | 458 | - | |||
Convertible loan | - | 2,688 | |||
Inventory | 34 | 120 | |||
Total current assets | 4,076 | 46,318 | |||
NON CURRENT ASSETS: | |||||
Deposits | $ | 38 | $ | 331 | |
Equity investees | 8 | 39 | |||
Loans to associates | - | 96 | |||
Property, plants and equipment, net | 1,475 | 22,834 | |||
Intangible assets, net | 7,375 | 9,694 | |||
Operating lease right-of-use assets | 351 | 2,304 | |||
1,211 | 8,187 | ||||
Deferred tax | - | 103 | |||
Other assets | 18 | 1,022 | |||
Total non-current assets | 10,476 | 44,610 | |||
TOTAL ASSETS | $ | 14,552 | $ | 90,928 | |
CONSOLIDATED BALANCE SHEETS ( | |||||||
2023 | 2022 | ||||||
CURRENT LIABILITIES: | |||||||
Accounts payable | $ | 6,451 | $ | 4,429 | |||
Accounts payable related Parties | 133 | - | |||||
Accrued expenses and other payables | 2,218 | 2,648 | |||||
Income tax payable | 740 | 289 | |||||
Employees and related payables | 1,079 | 1,860 | |||||
Other payable related parties | 52 | - | |||||
Advance payments on account of grant | 2,180 | 1,578 | |||||
Short-term loans | 650 | - | |||||
Current maturities of finance leases | 18 | 60 | |||||
Current maturities of operating leases | 216 | 542 | |||||
Short-term and current maturities of convertible loans | 2,670 | 4,504 | |||||
TOTAL CURRENT LIABILITIES | 16,407 | 15,910 | |||||
LONG-TERM LIABILITIES: | |||||||
Non-current operating leases | $ | 96 | $ | 1,728 | |||
Convertible loans | 18,967 | 13,343 | |||||
Retirement benefits obligation | - | 163 | |||||
Finance leases | 4 | 95 | |||||
Other long-term liabilities | 61 | 415 | |||||
TOTAL LONG-TERM LIABILITIES | 19,128 | 15,744 | |||||
TOTAL LIABILITIES | 35,535 | 31,654 | |||||
REDEEMABLE NON-CONTROLLING INTEREST | - | 30,203 | |||||
EQUITY (CAPITAL DEFICIENCY): | |||||||
Common stock of Authorized at | 3 | 3 | |||||
Additional paid-in capital | 156,837 | 150,355 | |||||
Accumulated other comprehensive income (loss) | 65 | (270 | ) | ||||
(1,266 | ) | (1,266 | ) | ||||
Accumulated deficit | (176,622 | ) | (121,261 | ) | |||
Equity attributable to | (20,983 | ) | 27,561 | ||||
Non-controlling interests | - | 1,510 | |||||
TOTAL EQUITY (CAPITAL DEFICIENCY) | (20,983 | ) | 29,071 | ||||
TOTAL LIABILITIES, REDEEMABLE NON-CONTROLLING INTEREST AND EQUITY (CAPITAL DEFICIENCY) | $ | 14,552 | $ | 90,928 |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (INCOME) ( | |||||||
Years Ended | |||||||
2023 | 2022 | ||||||
Revenues | $ | 530 | $ | 34,741 | |||
Revenues from related party | - | 1,284 | |||||
Total revenues | $ | 530 | $ | 36,025 | |||
Cost of revenues | 6,255 | 5,133 | |||||
Gross (loss) profit | $ | (5,725 | ) | $ | 30,892 | ||
Cost of development services and research and development expenses | 10,623 | 21,933 | |||||
Amortization of intangible assets | 721 | 911 | |||||
Selling, general and administrative expenses included credit losses of | 35,134 | 15,589 | |||||
Share in net loss of associated companies | 734 | 1,508 | |||||
Impairment of investment | 699 | - | |||||
Impairment of intangible assets | - | 1,061 | |||||
Operating loss | $ | 53,636 | $ | 10,110 | |||
Loss from deconsolidation of Octomera (see Note 3) | 5,343 | - | |||||
Other income, net | (4 | ) | (173 | ) | |||
Credit loss on convertible loan receivable | 2,688 | - | |||||
Loss from extinguishment in connection with convertible loan | 283 | 52 | |||||
Financial expenses, net | 2,499 | 1,971 | |||||
Loss before income taxes | $ | 64,445 | $ | 11,960 | |||
Tax expense | 473 | 209 | |||||
Net loss | $ | 64,918 | $ | 12,169 | |||
Net (loss) income attributable to non-controlling interests | (9,557 | ) | 2,720 | ||||
Net loss attributable to | $ | 55,361 | $ | 14,889 | |||
Loss per share: | |||||||
Basic and diluted | $ | 1.91 | $ | 0.59 | |||
Weighted average number of shares used in computation of Basic and Diluted loss per share: | |||||||
Basic and diluted | 29,007,869 | 25,096,284 | |||||
Comprehensive loss: | |||||||
Net loss | $ | 64,918 | $ | 12,169 | |||
Other Comprehensive loss – Translation adjustment | 49 | 477 | |||||
Release of translation adjustment due to deconsolidation of Octomera | (384 | ) | - | ||||
Comprehensive loss | $ | 64,583 | $ | 12,646 | |||
Comprehensive (loss) income attributed to non-controlling interests | (9,557 | ) | 2,720 | ||||
Comprehensive loss attributed to | $ | 55,026 | $ | 15,366 |
Source:
2024 GlobeNewswire, Inc., source