Acquired GMP-validated platforms for launching proprietary CAR-T, tumor-infiltrating lymphocytes, lentivirus vectors, oncolytic virus cell carriers, and therapeutic exosomes
GERMANTOWN, Md., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Orgenesis Inc. ( ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGT) in order to improve access and outcomes in healthcare, today provided a business update for the second quarter ended June 30, 2024.
Vered Caplan, CEO of Orgenesis, stated, “After more than a decade of parallel efforts—on one hand, establishing robust capabilities in cell therapy production by initially serving the industry in a centralized manner and later integrating these capabilities into a decentralized platform, and on the other, forming partnerships through joint ventures and licenses to develop a wide range of therapies—we have finally reached the point where we can integrate these two paths. We are now offering hospitals and partners not only our services for their own development and products but also the opportunity to benefit from our own proprietary therapies. We recently completed the acquisition of GMP-validated platforms for producing CAR-T, tumor-infiltrating lymphocytes, lentivirus vectors, oncolytic virus cell carriers, and therapeutic exosomes—and we intend to utilize this platform to supply our own CAR-T cell products. We are proud to introduce these potential breakthrough therapies and processes, which we believe can elevate our decentralized platform by providing a comprehensive solution for the industry, including hospitals and researchers around the world. We look forward to providing further updates on key initiatives underway in the weeks and months ahead.”
The complete financial results for the second quarter of 2024 are available in the Company’s Form 10-Q, which has been filed with the Securities and Exchange Commission.
About Orgenesis
Orgenesis is a global biotech company that has been committed to unlocking the potential of cell and gene therapies (CGTs) since 2012 as well as a paradigm-shifting decentralized approach to processing since 2020. This new model allows Orgenesis to bring academia, hospitals, and industry together to make these essential therapies a reality sooner rather than later. Orgenesis is focusing on advancing its CGTs toward eventual commercialization, while partnering with key industry stakeholders to provide a rapid, globally harmonized pathway for these therapies to reach and treat a larger numbers of patients more cost effectively and with better outcomes through great science and decentralized production. Additional information about the Company is available at: www.orgenesis.com.
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 service 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 December 31, 2023, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.
IR contact for Orgenesis:
Crescendo Communications, LLC
Tel: 212-671-1021
[email protected]
Communications contact for Orgenesis
IB Communications
Michelle Boxall
Tel +44 (0)20 8943 4685
[email protected]
(tables follow)
| ORGENESIS INC. CONSOLIDATED BALANCE SHEETS (U.S. Dollars, in thousands) | |||||
| As of | |||||
| June 30, 2024 | December 31, 2023 | ||||
| Assets | |||||
| CURRENT ASSETS: | |||||
| Cash and cash equivalents | $ | 77 | $ | 837 | |
| Restricted cash | 1,079 | 642 | |||
| Accounts receivable, net of credit losses of $29,234 as of June 30, 2024 ($0 as of December 31, 2023) | 240 | 88 | |||
| Prepaid expenses and other receivables | 952 | 2,017 | |||
| Receivable from related parties | - | 458 | |||
| Inventory | - | 34 | |||
| Total current assets | 2,348 | 4,076 |
| NON-CURRENT ASSETS: |
| Deposits | $ | 249 | $ | 38 | |
| Investments to associates | 8 | 8 | |||
| Property, plant and equipment, net | 15,901 | 1,475 | |||
| Intangible assets, net | 8,724 | 7,375 | |||
| Operating lease right-of-use assets | 1,805 | 351 | |||
| Goodwill | 1,211 | 1,211 | |||
| Other assets | 331 | 18 | |||
| Total non-current assets | 28,229 | 10,476 | |||
| TOTAL ASSETS | $ | 30,577 | $ | 14,552 | |
| CONSOLIDATED BALANCE SHEETS (U.S. Dollars, in thousands) | |||||||
| As of | |||||||
| June 30, 2024 | December 31, 2023 | ||||||
| Liabilities net of (Capital Deficiency) | |||||||
| CURRENT LIABILITIES: | |||||||
| Accounts payable | $ | 10,717 | $ | 6,451 | |||
| Accounts payable related Parties | 2,696 | 133 | |||||
| Advance payments from Germfree (See note 11a) | 6,720 | - | |||||
| Accrued expenses and other payables | 2,789 | 2,218 | |||||
| Income tax payable | 767 | 740 | |||||
| Employees and related payables | 1,634 | 1,079 | |||||
| Other payable related parties | - | 52 | |||||
| Advance payments on account of grant | 2,733 | 2,180 | |||||
| Short-term loans | 1,186 | 650 | |||||
| Current maturities of finance leases | 62 | 18 | |||||
| Current maturities of operating leases | 465 | 216 | |||||
| Short-term and current maturities of convertible loans | 1,931 | 2,670 | |||||
| TOTAL CURRENT LIABILITIES | 31,700 | 16,407 |
| LONG-TERM LIABILITIES: | |||||||
| Non-current operating leases | $ | 1,318 | $ | 96 | |||
| Loans payable | 2,762 | - | |||||
| Convertible loans | 5,296 | 18,967 | |||||
| Retirement benefits obligation | 96 | - | |||||
| Finance leases | 1 | 4 | |||||
| Contingent consideration (see note 4) | 4,825 | - | |||||
| Other long-term liabilities | 371 | 61 | |||||
| TOTAL LONG-TERM LIABILITIES | 14,669 | 19,128 | |||||
| TOTAL LIABILITIES | 46,369 | 35,535 |
| CAPITAL DEFICIENCY: | |||||||
| Common stock of $0.0001 par value: Authorized at June 30, 2024 and December 31, 2023: 145,833,334 shares; Issued at June 30, 2024 and December 31, 2023: 47,212,473 and 32,163,630 shares, respectively; Outstanding at June 30, 2024 and December 31, 2023: 46,925,906 and 31,877,063 shares, respectively | $ | 5 | $ | 3 | |||
| Additional paid-in capital | 180,752 | 156,837 | |||||
| Accumulated other comprehensive income | 302 | 65 | |||||
| Treasury stock 286,567 shares as of June 30, 2024 and December 31, 2023 | (1,266) | (1,266) | |||||
| Accumulated deficit | (195,291) | (176,622) | |||||
| Equity attributable to Orgenesis Inc. | (15,498) | (20,983) | |||||
| Non-controlling interest | (294) | - | |||||
| TOTAL CAPITAL DEFICIENCY | (15,792) | (20,983) | |||||
| TOTAL LIABILITIES AND CAPITAL DEFICIENCY | $ | 30,577 | $ | 14,552 | |||
| ORGENESIS INC. CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (U.S. Dollars, in thousands, except share and per share amounts) | |||||||||
| Three Months Ended | Six Months Ended | ||||||||
| June 30, 2024 | June 30, 2023 | June 30, 2024 | June 30, 2023 | ||||||
| Revenues | $ | 246 | $ | 113 | $ | 387 | $ | 255 | |||||||
| Cost of revenues | 538 | 3,232 | 1,030 | 5,954 | |||||||||||
| Gross profit | (292 | ) | (3,119 | ) | (643 | ) | (5,699 | ) | |||||||
| Cost of development services and research and development expenses | 1,489 | 3,527 | 3,859 | 6,808 | |||||||||||
| Amortization of intangible assets | 226 | 208 | 379 | 415 | |||||||||||
| Change in Contingent consideration | 182 | - | 182 | - | |||||||||||
| Selling, general and administrative expenses including credit losses of $2,725 for the six months ended June 30, 2024 and $(500) for the three months ended June 30, 2024 and $24,367 for the six months ended June 30, 2023 and $14,878 for the three months ended June 30, 2023 | 2,061 | 18,216 | 8,117 | 31,744 | |||||||||||
| Operating loss | 4,250 | 25,070 | 13,180 | 44,666 | |||||||||||
| Loss from deconsolidation of OBI and Octomera (see note 4) | - | 5,343 | 66 | 5,343 | |||||||||||
| Other income, net | (8 | ) | - | (8 | ) | (2 | ) | ||||||||
| Credit loss on convertible loan receivable | - | - | - | 2,688 | |||||||||||
| Loss from extinguishment in connection with convertible loan | - | - | 141 | 283 | |||||||||||
| Financial expenses, net | 815 | 692 | 1,667 | 1,373 | |||||||||||
| Convertible loans induced conversion expenses | 4,304 | - | 4,304 | - | |||||||||||
| Share in net loss profit of associated companies | - | (3 | ) | - | (1 | ) | |||||||||
| Loss before income taxes | 9,361 | 31,102 | 19,350 | 54,350 | |||||||||||
| Tax expenses | 5 | 91 | 21 | 220 | |||||||||||
| Net loss | 9,366 | 31,193 | 19,371 | 54,570 | |||||||||||
| Net loss attributable to non-controlling interests (including redeemable) | (462 | ) | (5,650 | ) | (702 | ) | (9,557 | ) | |||||||
| Net loss attributable to Orgenesis Inc. | $ | 8,904 | $ | 25,543 | $ | 18,669 | $ | 45,013 |
| Loss per share: | |||||||||||||||
| Basic and diluted | $ | 0.23 | $ | 0.76 | $ | 0.52 | $ | 1.63 | |||||||
| Weighted average number of shares used in computation of Basic and Diluted loss per share: | |||||||||||||||
| Basic and diluted | 38,860,727 | 28,603,597 | 35,979,567 | 27,546,229 | |||||||||||
| Comprehensive loss: | |||||||||||||||
| Net loss | $ | 9,366 | $ | 31,193 | $ | 19,371 | $ | 54,570 | |||||||
| Other comprehensive loss (income) - translation adjustments | (176 | ) | 11 | (237 | ) | 52 | |||||||||
| Release of translation adjustment due to deconsolidation of Octomera | - | (384 | ) | - | (384 | ) | |||||||||
| Comprehensive loss | 9,190 | 30,820 | 19,134 | 54,238 | |||||||||||
| Comprehensive loss attributed to non-controlling interests | (462 | ) | (5,650 | ) | (702 | ) | (9,557 | ) | |||||||
| Comprehensive loss attributed to Orgenesis Inc. | $ | 8,728 | $ | 25,170 | $ | 18,432 | $ | 44,681 | |||||||
