Orgenesis Provides Third Quarter 2024 Business Update

Rhea-AI Summary

Orgenesis (OTCQX: ORGS) provided its Q3 2024 business update, highlighting progress in decentralized cell and gene therapies. Their CD19 CAR-T therapy, ORG-101, showed impressive results with 82% complete response rate in adults and 93% in pediatric patients with CD19+ Acute Lymphoblastic Leukemia. The therapy demonstrated lower severe Cytokine Release Syndrome incidence (2% adults, 6% pediatric) compared to conventional treatments. The company is initiating a Phase 1/2 multicenter clinical study in Greece and announced a strategic joint venture with Harley Street Healthcare Group focusing on wellness and longevity services in the UK, UAE, and Canada.

Positive

• ORG-101 achieved 82% complete response rate in adults
• 93% complete response rate in pediatric patients
• Lower severe Cytokine Release Syndrome incidence compared to conventional therapies
• Secured grant from Enterprise Greece for clinical studies
• Strategic joint venture with Harley Street Healthcare Group expanding market reach

Negative

• None.

Insights

Medical Research Analyst

The clinical data for ORG-101 CAR-T therapy shows promising results with 82% and 93% complete response rates in adult and pediatric CD19+ ALL patients respectively. The significantly lower severe Cytokine Release Syndrome rates of 2% in adults and 6% in pediatrics compared to traditional CAR-T therapies represent a meaningful safety improvement. The initiation of a Phase 1/2 multicenter study in Greece, supported by Enterprise Greece grant, marks important progress in clinical development.

The company's decentralized manufacturing approach could potentially reduce production costs and improve accessibility of CAR-T therapies. The joint venture with Harley Street Healthcare Group to expand into wellness and longevity markets represents diversification of the technology platform, though commercial success remains to be proven. However, no financial figures were provided to assess the company's current performance and cash position.

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 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
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

FAQ

What were the clinical results for Orgenesis ORG-101 CAR-T therapy in Q3 2024?

ORG-101 achieved an 82% complete response rate in adults and 93% in pediatric patients with CD19+ Acute Lymphoblastic Leukemia, with lower severe Cytokine Release Syndrome incidence of 2% in adults and 6% in pediatric patients.

Where is Orgenesis (ORGS) conducting its new Phase 1/2 clinical study for ORG-101?

Orgenesis is conducting the Phase 1/2 multicenter clinical study at the University General Hospital of Patras and George Papanikolaou General Hospital of Thessaloniki in Greece.

What new strategic partnership did Orgenesis (ORGS) announce in Q3 2024?

Orgenesis announced a strategic joint venture with Harley Street Healthcare Group to develop wellness and longevity services targeting markets in the UK, UAE, and Canada.