Orgenesis Achieves Revenue of $7.2 Million for the Second Quarter of 2022

Secures Funding from Metalmark Capital Partners to Drive Growth

Orgenesis to Host Conference Call Today, August 16, 2022 at 11 AM Eastern Time

GERMANTOWN, Md., Aug. 16, 2022 (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 second quarter ending June 30, 2022.

Vered Caplan, CEO of Orgenesis, said, "We are progressing with our transition to the second phase of the planned rollout of our POCare platform. This includes revenue generation from the validation, process development, and supply of advanced therapies that utilize our POCare platform and Orgenesis Mobile Processing Units and Labs (OMPULs). As a result of the successful execution of the first phase, our global supply network now spans North America, Europe, Asia, and the Middle East. Within the U.S. specifically, we are expanding our capacity and collaborations with a number of leading global healthcare institutions such as Johns Hopkins to establish a new POCare Center, also known as the Maryland Center for Cell Therapy Manufacturing."

"Feedback from within the industry based on Orgenesis' progress has been overwhelmingly positive. This is a result of our ability to reduce costs and add capacity in significantly less time than required for traditional clean rooms. We have multiple contracts with biotech companies from the U.S., E.U., Asia and the Middle East. Importantly, we believe we have built a highly scalable business model, and expect to benefit from growth in high margin, recurring revenue streams, based on future royalties and long-term contracts for industrializing and supplying these cell and gene therapies."

Ms. Caplan continued, "I am pleased to report that we secured a $10 million loan within our newly formed subsidiary for Orgenesis' point of care services business for treating patients (POCare Services) with Metalmark Capital Partners, a premier investment firm with deep expertise in the healthcare sector. Metalmark will provide ongoing advice to help us accelerate the rollout of our POCare platform and these critical CGT services."

"In addition to our POCare Services platform, we are advancing our POCare therapeutic pipeline, which now spans over 16 distinct clinical programs in the field of immuno-oncology, anti-viral, metabolic/auto-immune diseases, and tissue regeneration. Our cost-efficient strategy involves leveraging government grants and funding from regional partners for our innovations and in-licensed therapies from leading research centers, hospitals and biotech companies. Most recently, in May 2022, we were awarded a €4M European Innovation Council Pathfinder Grant to advance technologies for the production of personalized autologous induced pluripotent stem cells (iPSCs) that can be utilized for regenerative medicine. Overall, we believe our therapeutic pipeline holds unlocked potential as we advance each of these assets through key clinical and pre-clinical milestones."

The complete financial results for the second quarter of 2022 and details on the $10 million loan to our subsidiary are available on the Company's website in the Company's Form 10-Q and 8-K, respectively, which have been filed with the Securities and Exchange Commission.

Conference Call

The Company will host a conference call today, August 16, 2022, at 11:00 AM Eastern Time to discuss the company's corporate progress and other developments.

The conference call will be available via telephone by dialing toll free 888-506-0062 for U.S. callers or +1 973-528-0011 for international callers and using entry code 223911. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2585/46399 or on the Company's Investor Events section of the website here.

A webcast replay will be available on the Company's Investor Events section of the website (https://ir.orgenesis.com/events#/) through Wednesday, August 16, 2023. A telephone replay of the call will be available approximately one hour following the call, through Tuesday, August 30, 2022 and can be accessed by dialing 877-481-4010 for U.S. callers or +1 919-882-2331 for international callers and entering conference ID: 46399.

About Orgenesis

Orgenesis is a global biotech company working to unlock the full potential of cell and gene therapies (CGTs) in an affordable and accessible format at the point of care. The Orgenesis POCare Platform is comprised of three enabling components: a pipeline of licensed POCare Therapeutics that are processed and produced in closed, automated POCare Technology systems across a collaborative POCare Network. Orgenesis identifies promising new therapies and leverages its POCare Platform 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. The POCare Network brings together patients, doctors, industry partners, research institutes and hospitals worldwide to achieve harmonized, regulated clinical development and production of the therapies. 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, 2021, 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

Neil Hunter / Michelle Boxall

Tel +44 (0)20 8943 4685

[email protected] / [email protected]

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ORGENESIS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(U.S. Dollars in thousands)

(Unaudited)

		As of
		June 30, 2022				December 31, 2021
Assets
CURRENT ASSETS:
Cash and cash equivalents		$	2,303			$	5,473
Restricted cash			457				501
Accounts receivable, net *			18,786				15,245
Prepaid expenses and other receivables			793				1,188
Convertible loan receivable-related party			3,012				3,064
Grants receivable			-				169
Inventory			107				118
Total current assets			25,458				25,758
NON-CURRENT ASSETS:
Deposits		$	329			$	363
Investments and loans to associates			1,750				584
Loans receivable			-				821
Property, plant and equipment, net			14,388				10,271
Intangible assets, net			11,207				11,821
Operating lease right-of-use assets			757				1,015
Goodwill			8,174				8,403
Other assets			736				805
Total non-current assets			37,341				34,083
TOTAL ASSETS		$	62,799			$	59,841

 

*	Including related party in the amount of $2,039 thousand and $1,972 thousand as of June 30, 2022 and as of December 31, 2021, respectively.

ORGENESIS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (Cont'd)

(U.S. Dollars in thousands)

(Unaudited)

		As of
		June 30, 2022				December 31, 2021
Liabilities and Equity
CURRENT LIABILITIES:
Accounts payable		$	5,203			$	5,238
Accrued expenses and other payables			1,763				485
Income tax payable			83				54
Employees and related payables			1,998				1,907
Advance payments on account of grant			1,144				1,238
Contract liabilities			70				59
Current maturities of finance leases			17				18
Current maturities of operating leases			399				481
Current maturities of convertible loans			5,568				5,885
Total current liabilities			16,245				15,365
LONG-TERM LIABILITIES:
Non-current operating leases		$	352			$	561
Convertible loans			13,943				4,854
Retirement benefits obligation			123				101
Non-current finance leases			29				41
Other long-term liabilities			264				288
Total long-term liabilities			14,711				5,845
TOTAL LIABILITIES			30,956				21,210
EQUITY:
Common stock of $0.0001 par value: Authorized at June 30, 2022 and December 31, 2021: 145,833,334 shares; Issued at June 30, 2022 and December 31, 2021: 25,107,323 and 24,567,366 shares, respectively; Outstanding at June 30, 2022 and December 31, 2021: 24,820,756 and 24,280,799 shares, respectively			3				3
Additional paid-in capital			146,919				145,916
Receipts on account of shares and warrants to be allotted			2,175				-
Accumulated other comprehensive income (loss)			(270	)			207
Treasury stock 286,567 shares as of June 30, 2022 and December 31, 2021			(1,266	)			(1,266	)
Accumulated deficit			(115,808	)			(106,372	)
Equity attributable to Orgenesis Inc.			31,753				38,488
Non-controlling interest			90				143
Total equity			31,843				38,631
TOTAL LIABILITIES AND EQUITY		$	62,799			$	59,841

 

ORGENESIS INC.

CONDENSED CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

(U.S. Dollars in thousands, except share and loss per share amounts)

(Unaudited)

		Three Months Ended								Six Months Ended
		June 30, 2022				June 30, 2021				June 30, 2022				June 30, 2021
Revenues		$	6,699			$	9,818			$	13,276			$	18,050
Revenues from related party			502				727				1,137				1,884
Total revenues			7,201				10,545				14,413				19,934
Cost of revenues, development services and research and development expenses			8,901				9,727				16,266				15,854
Amortization of intangible assets			229				239				461				477
Selling, general and administrative expenses			2,803				2,901				5,654				5,869
Operating loss			4,732				2,322				7,968				2,266
Other income, net			(8	)			(3	)			(8	)			(28	)
Financial expenses, net			389				406				602				639
Share in net loss of associated companies			368				-				915				15
Loss before income taxes			5,481				2,725				9,477				2,892
Tax expenses (income)			11				-				12				(2	)
Net loss			5,492				2,725				9,489				2,890
Net loss attributable to non-controlling interests			(65	)			(66	)			(53	)			(12	)
Net loss attributable to Orgenesis Inc.		$	5,427			$	2,659			$	9,436			$	2,878
Loss per share:
Basic and diluted		$	0.22			$	0.11			$	0.38			$	0.12
Weighted average number of shares used in computation of Basic and Diluted loss per share:
Basic and diluted			24,820,756				24,365,746				24,711,462				24,279,826
Comprehensive loss:
Net loss		$	5,492			$	2,725			$	9,489			$	2,890
Other comprehensive loss (income) - translation adjustments			326				(48	)			477				229
Comprehensive loss			5,818				2,677				9,966				3,119
Comprehensive loss attributed to non-controlling interests			(65	)			(66	)			(53	)			(12	)
Comprehensive loss attributed to Orgenesis Inc.		$	5,753			$	2,611			$	9,913			$	3,107