Orgenesis Provides Business Update for the Third Quarter of 2023

Rhea-AI Summary

Orgenesis Inc. (NASDAQ: ORGS) provided a business update for the third quarter ended September 30, 2023, highlighting the advances in the rollout of its POCare Platform and POCare Therapies. The CEO, Vered Caplan, emphasized the expansion of partnerships with California Davis and CGT Global for streamlined production and accelerated research and clinical trials. The Company's focus on advancing cell and gene therapies across the U.S., Europe, the Middle East, and other regions is evident in its efforts to build a decentralized network and infrastructure through Octomera, aiming to meet the growing demand for these advanced therapeutic services. Additionally, Orgenesis is advancing its therapeutic pipeline, spanning multiple clinical programs in immuno-oncology, anti-viral, metabolic/autoimmune diseases, and tissue regeneration, while leveraging government grants and funding from regional partners.

Advances rollout of POCare Platform and POCare Therapies

GERMANTOWN, Md., Nov. 13, 2023 (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), today provided a business update for the third quarter ended September 30, 2023.

Vered Caplan, CEO of Orgenesis, said, “We continue to advance the commercial launch of our POCare Platform through Octomera, building out a decentralized network and infrastructure to deliver these advanced therapeutic services that are critically needed by the medical community. At the same time, we are focused on growing our POCare Network of hospitals and healthcare providers across the U.S., Europe, the Middle East and other regions, where advanced cell and gene therapies can be rapidly scaled up to meet growing demand across the industry. We believe the Company is well positioned to support the clinical and commercial advancement of these therapies for years to come.”

“Recently, we expanded our partnership with California Davis (UC Davis) through California Institute of Regenerative Medicine (CIRM) grant funding to streamline production of CGT products across California. We believe that our platform will benefit patients in the state by accelerating access to CGT products in an affordable format at the point of care, which, in turn, are expected to lower costs, expand capacity, and enhance distribution. We remain on track to deploy our Octomera Mobile Processing Units & Labs (OMPULs) for production at UC Davis and other healthcare universities within the State of California in the upcoming year. Moreover, Octomera entered into an agreement with CGT Global to utilize its extensive network of U.S. clinics to help accelerate research and clinical trials, aimed at rapidly commercializing CGT products across the United States and potentially bringing these life-saving therapies to larger numbers of patients in need.”

Ms. Caplan continued, “In addition to our POCare Services platform, we are advancing our therapeutic pipeline, which now spans multiple clinical programs in the field of immuno-oncology, anti-viral, metabolic/autoimmune diseases, and tissue regeneration. Our cost-efficient strategy includes leveraging government grants and funding from regional partners, as well finding the optimal licensing and marketing partners for some of the more advanced products in our pipeline. Importantly, we believe we have built a highly scalable business model.”

The complete financial results for the third quarter of 2023 are available on the Company’s website in the Company’s Form 10-Q, which has been filed with the Securities and Exchange Commission. It is important to note that the Company deconsolidated Octomera on June 30, 2023, though the Company still holds a 75% stake in the business. Accordingly, the results of Octomera’s operations subsequent to June 30, 2023, are not reflected in the Company’s consolidated financial statements. Octomera itself recognized revenue of $2.7 million, reflecting a temporary delay in cell processing and cell process development contracts, which are expected to be completed in the fourth quarter of 2023 and first quarter of 2024. The Company also notes that as a result of the deconsolidation of Octomera, the assets and liabilities of Octomera are not included on the Company’s balance sheet and statements of comprehensive loss for the period ended September 30, 2023.

About Orgenesis
Orgenesis is a global biotech company that has been committed to unlocking the potential of decentralized cell and gene therapies (CGTs) since 2012. Orgenesis established the POCare Network in 2020 to bring academia, hospitals, and Industry together to make these innovations more affordable and accessible to patients. In 2022, the POCare Services business unit responsible for developing and managing the decentralized POCare Centers and proprietary OMPULs was formed. Orgenesis will continue to focus on advancing to market through various partnerships to provide a rapid, globally harmonized pathway for these therapies to reach and treat large numbers of patients at lowered costs through efficient, scalable, 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, 2022, 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
Neil Hunter / Michelle Boxall
Tel +44 (0)20 8943 4685
neil@ibcomms.agency / michelle@ibcomms.agency

ORGENESIS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. Dollars, in thousands)
(Unaudited)

		As of
		September 30, 2023				December 31, 2022
Assets
CURRENT ASSETS:
Cash and cash equivalents	$	55			$	5,311
Restricted cash		734				1,058
Accounts receivable, net		71				36,183
Prepaid expenses and other receivables		4,031				958
Receivables from related parties		1,052				-
Convertible loan to related party		2,799				2,688
Inventory		34				120
Total current assets		8,776				46,318
NON-CURRENT ASSETS:
Deposits	$	40			$	331
Equity investees		22,509				39
Loans to associates		93				96
Property, plant and equipment, net		1,503				22,834
Intangible assets, net		7,528				9,694
Operating lease right-of-use assets		431				2,304
Goodwill		3,703				8,187
Deferred tax		-				103
Other assets		716				1,022
Total non-current assets		36,523				44,610
TOTAL ASSETS	$	45,299			$	90,928

ORGENESIS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. Dollars, in thousands)
(Unaudited)

		As of
		September 30, 2023				December 31, 2022
Liabilities and Equity
CURRENT LIABILITIES:
Accounts payable	$	5,459			$	4,429
Accounts payable related parties		132				-
Accrued expenses and other payables		1,895				2,578
Income tax payable		307				289
Employees and related payables		807				1,860
Other payables related parties		999				-
Advance payments on account of grant		1,376				1,578
Short-term loans		430				-
Contract liabilities		120				70
Current maturities of finance leases		17				60
Current maturities of operating leases		220				542
Short-term and current maturities of convertible loans		2,540				4,504
Total current liabilities		14,302				15,910
LONG-TERM LIABILITIES:
Non-current operating leases	$	140			$	1,728
Convertible loans		18,394				13,343
Retirement benefits obligation		-				163
Long-term debt and finance leases		8				95
Advance payments on account of grant		-				144
Other long-term liabilities		58				271
Total long-term liabilities		18,600				15,744
TOTAL LIABILITIES		32,902				31,654
REDEEMABLE NON-CONTROLLING INTEREST	$	-			$	30,203
EQUITY: Common stock of $0.0001 par value: Authorized at September 30, 2023 and December 31, 2022: 145,833,334 shares; Issued at September 30, 2023 and December 31, 2022: 30,753,374 and 25,832,322 shares, respectively; Outstanding at September 30, 2023 and December 31, 2022: 30,466,807 and 25,545,755 shares, respectively		3				3
Additional paid-in capital		155,819				150,355
Accumulated other comprehensive income (loss)		71				(270	)
Treasury stock 286,567 shares as of September 30, 2023 and December 31, 2022		(1,266	)			(1,266	)
Accumulated deficit		(142,230	)			(121,261	)
Equity attributable to Orgenesis Inc.		12,397				27,561
Non-controlling interest		-				1,510
Total equity		12,397				29,071
TOTAL LIABILITIES REDEEMABLE NON-CONTROLLING INTEREST AND EQUITY	$	45,299			$	90,928

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, 2023				September 30, 2022				September 30, 2023				September 30, 2022
Revenues	$	110			$	7,841			$	14,129			$	21,117
Revenues from related party		-				147				-				1,284
Total revenues		110				7,988				14,129				22,401
Cost of revenues		139				983				6,093				2,760
Gross profit (loss)		(29	)			7,005				8,036				19,641
Cost of development services and research and development expenses		808				3,683				7,616				18,172
Amortization of intangible assets		153				225				568				686
Selling, general and administrative expenses		1,245				3,104				8,621				8,758
Operating loss		2,235				7				8,769				7,975
Other loss (income), net		(2	)			2				(4	)			(6	)
Loss from extinguishment in connection with convertible loan		-				-				283				-
Financial expenses, net		508				1,100				1,807				1,702
Profit from deconsolidation of Octomera (see note 3)		-				-				(411	)			-
Share in net loss of associated companies		9,518				274				9,517				1,189
Loss before income taxes		12,259				1,383				19,961				10,860
Tax expenses		394				25				614				37
Net loss		12,653				1,408				20,575				10,897
Net income (loss) attributable to non-controlling interests (including redeemable)		-				(52	)			394				(105	)
Net loss attributable to Orgenesis Inc.	$	12,653			$	1,356			$	20,969			$	10,792
Loss per share:
Basic and diluted	$	0.43			$	0.05			$	0.75			$	0.43
Weighted average number of shares used in computation of Basic and Diluted loss per share:
Basic and diluted		29,162,459				25,403,907				27,933,067				24,944,814
Comprehensive loss:
Net loss	$	12,653			$	1,408			$	20,575			$	10,897
Other comprehensive loss (income) - translation adjustments		(9	)			556				43				1,033
Release of translation adjustment due to deconsolidation of Octomera		-				-				(384	)			-
Comprehensive loss		12,644				1,964				20,234				11,930
Comprehensive income (loss) attributed to non-controlling interests		-				(52	)			394				(105	)
Comprehensive loss attributed to Orgenesis Inc.	$	12,644			$	1,912			$	20,628			$	11,825

FAQ

What is Orgenesis Inc. working on?

Orgenesis Inc. is working to unlock the full potential of cell and gene therapies (CGT) through the rollout of its POCare Platform and POCare Therapies, as well as advancing its therapeutic pipeline in various clinical programs.

Who is the CEO of Orgenesis Inc.?

The CEO of Orgenesis Inc. is Vered Caplan, who provided insights into the Company's business update and strategic partnerships.

What partnerships has Orgenesis Inc. expanded recently?

Orgenesis Inc. expanded its partnership with California Davis (UC Davis) through California Institute of Regenerative Medicine (CIRM) grant funding and entered into an agreement with CGT Global to accelerate research and clinical trials for CGT products.

What are the areas of focus for Orgenesis Inc.'s therapeutic pipeline?

Orgenesis Inc.'s therapeutic pipeline includes clinical programs in immuno-oncology, anti-viral, metabolic/autoimmune diseases, and tissue regeneration, reflecting a diverse range of focus areas.

Where can the complete financial results for the third quarter of 2023 be found?

The complete financial results for the third quarter of 2023 are available on Orgenesis Inc.'s website in the Company’s Form 10-Q, filed with the Securities and Exchange Commission.