GERMANTOWN, Md., May 21, 2024 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: 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 first quarter ended March 31, 2024.
Vered Caplan, CEO of Orgenesis, said, “We continue to advance the commercialization of our decentralized platform through Octomera, our strategic CGT processing subsidiary, including our Orgenesis Mobile Processing Units and Labs (OMPULs). OMPULs offer a rapid, standardized industrial cleanroom alternative at or near the point of care, which can be rapidly deployed and scaled at a significantly lower cost than centralized production. Importantly, we recently regained 100% ownership of Octomera in a strategic transaction, which not only provides us full control over this subsidiary as we roll out these services to global customers, but also supports the development of our own proprietary therapeutic pipeline, including our immune-oncology portfolio. We believe the combination of our breakthrough therapies, coupled with our decentralized production of CGTs, have positioned Orgenesis to transform the industry by enabling the production of life-saving therapies in a fraction of the time and at much lower cost.
“We also recently announced a major strategic partnership with Germfree, a leading innovator in modular cleanroom infrastructure and services. Under the agreement, Germfree will co-market Orgenesis’ decentralized Octomera services and provide us access to Germfree’s global network and customer base. As a result, we plan to accelerate our go-to-market strategy with the OMPULs, while increasing our focus on our therapeutic pipeline. As part of our therapeutic strategy, we are effectively leveraging government grants and funding from regional partners. To date, we or our collaboration partners have been awarded over $50 million in potential future grant funding to support our development activities. With the addition of Germfree as a partner and the grants awarded but not yet spent, we believe that we have built a strong foundation.”
During March and April 2024, the Company received investments of approximately $2.5 million from a group of accredited investors, including a group of sophisticated, long-term healthcare professionals. Ms. Caplan concluded: “As a company dedicated to the goal of making cell and gene therapies available to all, we are always appreciative of our dedicated scientists and engineers whom are aligned with this goal and work around the globe to make this a reality for patients, as well as our supportive shareholders whom, on May 21, 2024, in a significant demonstration of such support of the Company, agreed to exchange approximately $16 million of debt for an aggregate of 15.8 million shares of common stock to be issued by the Company over time, subject to Nasdaq compliance limitations.”
The complete financial results for the first quarter of 2024 are available on the Company’s website 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 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 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
Orgs@crescendo-ir.com
Communications contact for Orgenesis
IB Communications
Michelle Boxall
Tel +44 (0)20 8943 4685
michelle@ibcomms.agency
(tables follow)
| ORGENESIS INC. CONSOLIDATED BALANCE SHEETS (U.S. Dollars, in thousands) | ||||||||
| As of | ||||||||
| March 31, 2024 | December 31, 2023 | |||||||
| Assets | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 80 | $ | 837 | ||||
| Restricted cash | 485 | 642 | ||||||
| Accounts receivable, net of credit losses of $29,760 as of March 31, 2024 ($0 as of December 31, 2023) | 245 | 88 | ||||||
| Prepaid expenses and other receivables | 1,112 | 2,017 | ||||||
| Receivables from related parties | - | 458 | ||||||
| Inventory | 34 | 34 | ||||||
| TOTAL CURRENT ASSETS | 1,956 | 4,076 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Deposits | $ | 255 | $ | 38 | ||||
| Investments in associates | 8 | 8 | ||||||
| Property, plant and equipment, net | 16,404 | 1,475 | ||||||
| Intangible assets, net | 8,950 | 7,375 | ||||||
| Operating lease right-of-use assets | 1,804 | 351 | ||||||
| Goodwill | 1,211 | 1,211 | ||||||
| Other assets | 332 | 18 | ||||||
| TOTAL NON-CURRENT ASSETS | 28,964 | 10,476 | ||||||
| TOTAL ASSETS | $ | 30,920 | $ | 14,552 | ||||
| CONSOLIDATED BALANCE SHEETS (U.S. Dollars, in thousands) | ||||||||
| As of | ||||||||
| March 31, 2024 | December 31, 2023 | |||||||
| Liabilities net of (Capital Deficiency) | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable | $ | 13,707 | $ | 6,451 | ||||
| Accounts payable related Parties | 2,697 | 133 | ||||||
| Accrued expenses and other payables | 4,106 | 2,218 | ||||||
| Income tax payable | 786 | 740 | ||||||
| Employees and related payables | 1,529 | 1,079 | ||||||
| Other payable related parties | - | 52 | ||||||
| Advance payments on account of grant | 2,695 | 2,180 | ||||||
| Short-term loans | 626 | 650 | ||||||
| Current maturities of finance leases | 65 | 18 | ||||||
| Current maturities of operating leases | 476 | 216 | ||||||
| Short-term and current maturities of convertible loans | 2,344 | 2,670 | ||||||
| TOTAL CURRENT LIABILITIES | 29,031 | 16,407 | ||||||
| LONG-TERM LIABILITIES: | ||||||||
| Non-current operating leases | $ | 1,274 | $ | 96 | ||||
| Loans payable | 2,696 | - | ||||||
| Convertible loans | 20,336 | 18,967 | ||||||
| Retirement benefits obligation | 98 | - | ||||||
| Finance leases | 14 | 4 | ||||||
| Contingent liability (see note 4) | 4,643 | - | ||||||
| Other long-term liabilities | 377 | 61 | ||||||
| TOTAL LONG-TERM LIABILITIES | 29,438 | 19,128 | ||||||
| TOTAL LIABILITIES | 58,469 | 35,535 | ||||||
| CAPITAL DEFICIENCY: | ||||||||
| Common stock of $0.0001 par value: Authorized at March 31, 2024 and December 31, 2023: 145,833,334 shares; Issued at March 31, 2024 and December 31, 2023: 34,625,349 and 32,163,630 shares, respectively; Outstanding at March 31, 2024 and December 31, 2023: 34,338,782 and 31,877,063 shares, respectively. | 4 | 3 | ||||||
| Additional paid-in capital | 159,650 | 156,837 | ||||||
| Receipts on account of shares to be allotted | 155 | - | ||||||
| Accumulated other comprehensive income | 126 | 65 | ||||||
| Treasury stock, 286,567 shares as of March 31, 2024 and December 31, 2023 | (1,266 | ) | (1,266 | ) | ||||
| Accumulated deficit | (186,386 | ) | (176,622 | ) | ||||
| Equity attributable to Orgenesis Inc. | (27,717 | ) | (20,983 | ) | ||||
| Non-controlling interest | 168 | - | ||||||
| TOTAL CAPITAL DEFICIENCY | (27,549 | ) | (20,983 | ) | ||||
| TOTAL LIABILITIES AND CAPITAL DEFICIENCY | $ | 30,920 | $ | 14,552 | ||||
| ORGENESIS INC. CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (INCOME) (U.S. Dollars, in thousands, except share and per share amounts) | ||||||||
| Three Months Ended | ||||||||
| March 31, | March 31, | |||||||
| 2024 | 2023 | |||||||
| Revenue | $ | 141 | $ | 142 | ||||
| Cost of revenues | 492 | 2,722 | ||||||
| Gross loss | (351 | ) | (2,580 | ) | ||||
| Cost of development services and research and development expenses | 2,370 | 3,281 | ||||||
| Amortization of intangible assets | 153 | 207 | ||||||
| Selling, general and administrative expenses including credit losses, net of $3,225 and $9,489 for the three months ended March 31, 2024 and 2023 respectively | 6,056 | 13,528 | ||||||
| Operating loss | 8,930 | 19,596 | ||||||
| Loss from deconsolidation | 66 | - | ||||||
| Other income, net | - | (2 | ) | |||||
| Loss from extinguishment in connection with convertible loan | 141 | 283 | ||||||
| Credit loss on convertible loan receivable | - | 2,688 | ||||||
| Financial expenses, net | 852 | 681 | ||||||
| Share in net loss of associated companies | - | 2 | ||||||
| Loss before income taxes | 9,989 | 23,248 | ||||||
| Tax expense | 16 | 129 | ||||||
| Net loss | 10,005 | 23,377 | ||||||
| Net income (loss) attributable to non-controlling interests (including redeemable) | (240 | ) | (3,907 | ) | ||||
| Net loss attributable to Orgenesis Inc. | 9,765 | 19,470 | ||||||
| Loss per share: | ||||||||
| Basic and diluted | $ | 0.29 | $ | 0.87 | ||||
| Weighted average number of shares used in computation of Basic and Diluted loss per share: | ||||||||
| Basic and diluted | 33,176,657 | 26,477,113 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | 10,005 | $ | 23,377 | ||||
| Other Comprehensive loss (income) – Translation adjustment | (61 | ) | 41 | |||||
| Comprehensive loss | 9,944 | 23,418 | ||||||
| Comprehensive loss attributed to non-controlling interests | (240 | ) | (3,907 | ) | ||||
| Comprehensive loss attributed to Orgenesis Inc. | $ | 9,704 | $ | 19,511 | ||||
