Orgenesis Provides Third Quarter 2024 Business Update
GERMANTOWN, Md., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Orgenesis Inc. (OTCQX: 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 third quarter ended September 30, 2024.
Vered Caplan, CEO of Orgenesis, stated, “Orgenesis is making significant progress in redefining accessibility to cell and gene therapies through our decentralized approach. This model is designed to expedite capacity setup, enhance production efficiency, and reduce treatment costs. We are dedicated to expanding our clinical initiatives and deepening global partnerships, creating a scalable and cost-effective pathway to advanced therapies. Our goal is to bring these innovative solutions to patients worldwide, focusing on sustainable growth and pioneering advancements in cell and gene therapies.
“In addition, as we previously disclosed, a recent real-world study of our CD19 CAR-T therapy, ORG-101, demonstrated efficacy and a favorable safety profile. ORG-101 achieved an 82% complete response rate in adults and a 93% complete response rate in pediatric patients with CD19+ Acute Lymphoblastic Leukemia, alongside a lower incidence of severe Cytokine Release Syndrome, 2% in adults and 6% in pediatric patients, compared to conventional CAR-T therapies. Beyond these positive clinical outcomes, we believe that the production data further validates Orgenesis’ decentralized approach as a cost-effective way to make CAR-T therapies more affordable and accessible globally. Additionally, we are excited to announce that we are initiating a Phase 1/2 multicenter clinical study of ORG-101 CAR-T therapy at the University General Hospital of Patras and "George Papanikolaou" General Hospital of Thessaloniki, in Greece, supported by the awarded grant by ‘Enterprise Greece’, with plans to expand to additional hospitals within our partnership network.
“We now offer hospitals, and research centers a unique partnership that enables a swift and cost-efficient way to build up their capacity and capability to provide cell and gene therapy products to their patients. Our decentralized platforms for various indications are quick to deploy and minimize the cost of production. We continue to be supported by strategic partners and government grants who share our goal of making cell and gene therapies available to all.
“Our strategic joint venture with Harley Street Healthcare Group (HSHG) is an additional angle of this approach, aimed at utilizing the know-how and technologies that we have developed for treatment of cancer and for the prevention of disease targeting the wellness and longevity sector. By combining our cell and gene therapy innovations with HSHG’s established healthcare network, we expect to introduce a suite of longevity and wellness services, targeting key markets such as the UK, UAE, and Canada. This partnership positions us to drive impactful healthcare innovations that can improve quality of life and longevity across diverse regions.”
The complete financial results for the third 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 platformandservicebusiness, our ability to achieve and maintain overall profitability,our ability tomanage our research and development programs that are based on noveltechnologies,our ability tocontrol key elements relating tothedevelopment and commercialization of therapeutic product candidates with third parties,thetiming 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 tomanage potential disruptions as a result of the COVID-19 pandemic,the sufficiency of working capital to realize our business plansandour ability toraise additional capital, the development ofourPOCarestrategy, our trans differentiationtechnologyas therapeutic treatment for diabetes, the technology behind our in-licensed ATMPsnot 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 alternativesto our products, risks relating to legal proceedings against usand 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
| ORGENESIS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. Dollars, in thousands) (Unaudited) | |||||
| As of | |||||
| September 30, 2024 | December 31, 2023 | ||||
| Assets | |||||
| CURRENT ASSETS: | |||||
| Cash and cash equivalents | $ | 204 | $ | 837 | |
| Restricted cash | 918 | 642 | |||
| Accounts receivable, net of credit losses of $14,397 as of September 30, 2024 ($0 as of December 31, 2023) | 161 | 88 | |||
| Prepaid expenses and other receivables | 1,236 | 2,017 | |||
| Receivables from related parties | - | 458 | |||
| Inventory | - | 34 | |||
| Total current assets | 2,519 | 4,076 | |||
| NON-CURRENT ASSETS: | |||||
| Deposits | $ | 55 | $ | 38 | |
| Investments to associates | 8 | 8 | |||
| Property, plant and equipment, net | 14,901 | 1,475 | |||
| Intangible assets, net | 8,528 | 7,375 | |||
| Operating lease right-of-use assets | 2,121 | 351 | |||
| Goodwill | 1,211 | 1,211 | |||
| Other assets | 344 | 18 | |||
| Total non-current assets | 27,168 | 10,476 | |||
| TOTAL ASSETS | $ | 29,687 | $ | 14,552 | |
| ORGENESIS INC. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. Dollars, in thousands) (Unaudited) | |||||||
| As of | |||||||
| September 30, 2024 | December 31, 2023 | ||||||
| Liabilities and Equity | |||||||
| CURRENT LIABILITIES: | |||||||
| Accounts payable | $ | 11,338 | $ | 6,451 | |||
| Accounts payable related parties | 2,699 | 133 | |||||
| Advance payments from Germfree (see note 11a) | 6,720 | - | |||||
| Accrued expenses and other payables | 2,690 | 2,218 | |||||
| Income tax payable | 784 | 740 | |||||
| Employees and related payables | 1,853 | 1,079 | |||||
| Other payables related parties | - | 52 | |||||
| Advance payments on account of grant | 2,771 | 2,180 | |||||
| Short-term loans | 4,905 | 650 | |||||
| Current maturities of finance leases | 46 | 18 | |||||
| Current maturities of operating leases | 277 | 216 | |||||
| Short-term and current maturities of convertible loans | 1,966 | 2,670 | |||||
| Total current liabilities | 36,049 | 16,407 | |||||
| LONG-TERM LIABILITIES: | |||||||
| Non-current operating leases | $ | 1,839 | $ | 96 | |||
| Loans payable | 2,828 | - | |||||
| Convertible loans | 5,435 | 18,967 | |||||
| Retirement benefits obligation | 101 | - | |||||
| Finance leases | 1 | 4 | |||||
| Contingent consideration (see note 4) | 4,906 | - | |||||
| Other long-term liabilities | 2,456 | 61 | |||||
| Total long-term liabilities | 17,566 | 19,128 | |||||
| TOTAL LIABILITIES | 53,615 | 35,535 | |||||
| CAPITAL DEFICIENCY: Common stock of $0.0001 par value: Authorized at September 30, 2024 and December 31, 2023: 14,583,333 shares; Issued at September 30, 2024 and December 31, 2023: 4,799,323 and 3,216,363 shares, respectively; Outstanding at September 30, 2024 and December 31, 2023: 4,770,666 and 3,187,706 shares, respectively | 5 | 3 | |||||
| Additional paid-in capital | 181,991 | 156,837 | |||||
| Accumulated other comprehensive income (loss) | (215 | ) | 65 | ||||
| Treasury stock 28,656 shares as of September 30, 2024 and December 31, 2023 | (1,266 | ) | (1,266 | ) | |||
| Accumulated deficit | (204,411 | ) | (176,622 | ) | |||
| Equity attributable to Orgenesis Inc. | (23,896 | ) | (20,983 | ) | |||
| Non-controlling interest | (32 | ) | - | ||||
| TOTAL CAPITAL DEFICIENCY | (23,928 | ) | (20,983 | ) | |||
| TOTAL LIABILITIES AND CAPITAL DEFICIENCY | $ | 29,687 | $ | 14,552 | |||
| ORGENESIS INC. CONDENSED CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (U.S. Dollars, in thousands, except share and per share amounts) (Unaudited) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| September 30, 2024 | September 30, 2023 | September 30, 2024 | September 30, 2023 | ||||||||||||
| Revenues | $ | 347 | $ | 110 | $ | 734 | $ | 365 | |||||||
| Cost of revenues | 585 | 139 | 1,615 | 6,093 | |||||||||||
| Gross profit (loss) | (238 | ) | (29 | ) | (881 | ) | (5,728 | ) | |||||||
| Cost of development services and research and development expenses | 4,523 | 808 | 8,382 | 7,616 | |||||||||||
| Amortization of intangible assets | 196 | 153 | 575 | 568 | |||||||||||
| Change in contingent consideration | 81 | - | 263 | - | |||||||||||
| Selling, general and administrative expenses including credit losses of $ 2,725 for the nine months ended September 30, 2024 and $0 for the three months ended September 30, 2024 and $24,367 for the nine months ended September 30, 2023 and $0 for the three months ended September 30, 2023 | 2,664 | 1,245 | 10,781 | 32,989 | |||||||||||
| Impairment expenses on Property, plant and equipment | 692 | - | 692 | - | |||||||||||
| Operating loss | 8,394 | 2,235 | 21,574 | 46,901 | |||||||||||
| Loss from deconsolidation of OBI and Octomera (see note 4) | - | - | 66 | 5,343 | |||||||||||
| Other income (expense), net | 122 | (2 | ) | 114 | (4 | ) | |||||||||
| Credit loss on convertible loan receivable | - | - | - | 2,688 | |||||||||||
| Loss from extinguishment in connection with convertible loan | - | - | 141 | 283 | |||||||||||
| Financial expenses, net | 718 | 545 | 2,385 | 1,918 | |||||||||||
| Convertible loans induced conversion expenses | - | - | 4,304 | - | |||||||||||
| Share in net loss of associated companies | - | 553 | - | 552 | |||||||||||
| Loss before income taxes | 9,234 | 3,331 | 28,584 | 57,681 | |||||||||||
| Tax expenses | 32 | 394 | 53 | 614 | |||||||||||
| Net loss | 9,266 | 3,725 | 28,637 | 58,295 | |||||||||||
| Net loss attributable to non-controlling interests (including redeemable) | (146 | ) | - | (848 | ) | (9,557 | ) | ||||||||
| Net loss attributable to Orgenesis Inc. | $ | 9,120 | $ | 3,725 | $ | 27,789 | $ | 48,738 | |||||||
| Loss per share: | |||||||||||||||
| Basic and diluted | $ | 1.93 | $ | 0.123 | $ | 7.06 | $ | 1.7 | |||||||
| Weighted average number of shares used in computation of Basic and Diluted loss per share: | |||||||||||||||
| Basic and diluted | 4,715,229 | 3,002,259 | 3,938,419 | 2,868,078 | |||||||||||
| Comprehensive loss: | |||||||||||||||
| Net loss | $ | 9,266 | $ | 3,725 | $ | 28,637 | $ | 58,295 | |||||||
| Other comprehensive loss (income) - translation adjustments | 517 | (9 | ) | 280 | 43 | ||||||||||
| Release of translation adjustment due to deconsolidation of Octomera | - | - | - | (384 | ) | ||||||||||
| Comprehensive loss | 9,783 | 3,716 | 28,917 | 57,954 | |||||||||||
| Comprehensive income (loss) attributed to non-controlling interests | (146 | ) | - | (848 | ) | (9,557 | ) | ||||||||
| Comprehensive loss attributed to Orgenesis Inc. | $ | 9,637 | $ | 3,716 | $ | 28,069 | $ | 48,397 | |||||||
