ORGS Orgenesis Inc

Orgenesis Inc. (NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies (CGTs), today reported financial results for the first quarter ended March 31, 2021.

Vered Caplan, CEO of Orgenesis, stated, “Our first quarter results illustrate the potential of our new POCare strategy, as evidenced by more than a four-fold increase in revenue for the first quarter of 2021. This growth is a direct result of long-term contracts with our regional partners as they work to advance our therapeutic pipeline and scale production capabilities in their respective territories. While we are in the early phases of our rollout, we achieved positive operating income for the quarter and are working aggressively to achieve our goal of building a sustainable long-term profitable business model, which we believe is achievable given the scalability of our POCare strategy. We have also maintained a solid balance sheet with $41.8 million of cash as of March 31, 2021.”

“The goal of our POCare platform is to provide life-changing treatments to large numbers of patients at reduced costs within the point-of-care setting. Initially, we are focusing on autologous, cell-based immunotherapies, therapeutics for metabolic diseases, anti-viral diseases, and tissue regeneration. Towards this end, we have built a robust therapeutic pipeline, which includes more than 30 advanced cell and gene therapies. We continue to expand our pipeline through our growing partnership with researchers, commercial partners and hospitals. As an example, in March, we entered into a second phase of collaboration with Hospital Infantil Universitario Niño Jesús in Madrid with an exclusive license to commercialize the Celyvir solid tumor therapy. At the same time, we have invested in new point-of-care technologies that can be integrated into our new Orgenesis Mobile Processing Units and Labs (OMPULs).”

“We continue to grow our POCare Network, which includes facilities in various countries across North America, Europe, Asia, and the Middle East. As an example, we recently began a collaboration with the Bambino Gesù Children's Hospital in Rome to establish a Point of Care Cell Therapy center at the hospital. We look forward to providing further updates as we advance our therapeutic pipeline, expand our hospital network and deploy our OMPULs worldwide.”

“Given the early stage of our POCare network, our reported revenues reflect just the first phase of our JV partnerships, as we establish point-of-care systems and capabilities for our partners. At the same time, these partners are investing in personnel, regulatory expenses and infrastructure in their respective territories as a basis for our therapeutic pipeline advancement. As our JV partners progress towards commercial production of cell therapies, we expect to continue to generate revenue from supporting them, as well as from future royalties. We believe this is a highly scalable model, substantially de-risked through outside capital from our partners.”

The Company’s complete financial results are available in the Company’s Form 10-Q filed with the Securities and Exchange Commission on May 6, 2021 which is available at www.sec.gov and on the Company’s website.

Conference Call

The Company plans to host a conference call at 8:30 AM Eastern Time today, May 7, 2021, to discuss the Company’s financial results for the first quarter ended March 31, 2021, as well as 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 173027. A webcast of the call may be accessed at https://www.webcaster4.com/Webcast/Page/2585/41278 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 Saturday, May 07, 2022. A telephone replay of the call will be available approximately one hour following the call, through Friday, May 21, 2021 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: 41278.

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. The Orgenesis Point of Care 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. Learn more about the work Orgenesis is doing at www.orgenesis.com.

Notice Regarding Forward-Looking StatementsThis 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, 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 coronavirus outbreak, the sufficiency of working capital to realize our business plans, 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 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, 2020, 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:David WaldmanCrescendo Communications, LLCTel: 212-671-1021ORGS@crescendo-ir.com

Communications contact for OrgenesisImage Box CommunicationsNeil Hunter / Michelle BoxallTel +44 (0)20 8943 4685neil@ibcomms.agency / michelle@ibcomms.agency

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

		As of
		March 31,2021					December 31,2020
Assets
CURRENT ASSETS:
Cash and cash equivalents		$	41,841				$	44,923
Restricted cash			471					645
Accounts receivable, net			11,354					3,085
Prepaid expenses and other receivables			679					1,070
Grants receivable			168					169
Inventory			200					185
Total current assets			54,713					50,077
NON-CURRENT ASSETS:
Deposits		$	348				$	296
Investments in associates, net			160					175
Property, plant and equipment, net			3,469					3,073
Intangible assets, net			12,675					13,023
Operating lease right-of-use assets			1,341					1,474
Goodwill			8,602					8,745
Other assets			802					821
Total non-current assets			27,397					27,607
TOTAL ASSETS		$	82,110				$	77,684

ORGENESIS INC.CONDENSED CONSOLIDATED BALANCE SHEETS (Cont’d)(U.S. Dollars in Thousands)(Unaudited)

		As of
		March 31,2021					December 31,2020
Liabilities and Equity
CURRENT LIABILITIES:
Accounts payable		$	10,294				$	8,649
Accrued expenses and other payables			987					792
Income tax payable			7					7
Employees and related payables			1,638					1,463
Advance payments on account of grant			1,126					692
Short-term loans and current maturities of long- term loans			-					145
Contract liabilities, mainly related party			59					59
Current maturities of finance leases			18					19
Current maturities of operating leases			474					485
Current maturities of convertible loans			4,327					3,974
Total current liabilities			18,930					16,285
LONG-TERM LIABILITIES:
Non-current operating leases		$	895				$	1,020
Convertible loans			7,082					7,200
Retirement benefits obligation			91					74
Non-current finance leases			57					64
Other long-term liabilities			303					313
Total long-term liabilities			8,428					8,671
TOTAL LIABILITIES			27,358					24,956
EQUITY:
Common stock of $0.0001 par value, 145,833,334 shares authorized, 24,469,406 and 24,223,093 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively			3					3
Additional paid-in capital			142,449					140,397
Receipts on account of shares to be allotted			424					-
Accumulated other comprehensive income			471					748
Treasury stock, 57,615 and 55,309 shares as of March 31, 2021 and December 31, 2020, respectively			(260	)				(250	)
Accumulated deficit			(88,538	)				(88,319	)
Equity attributable to Orgenesis Inc.			54,549					52,579
Non-controlling interest			203					149
Total equity			54,752					52,728
TOTAL LIABILITIES AND EQUITY		$	82,110				$	77,684

ORGENESIS INC.CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS(U.S. Dollars in Thousands, Except Share and Loss Per Share Amounts) (Unaudited)

		Three Months Ended
		March 31, 2021					March 31, 2020
Revenues		$	8,232				$	1,385
Revenues from related party			1,157					493
Total revenues			9,389					1,878
Cost of services and other research and development expenses			6,127					4,873
Amortization of intangible assets			238					223
Selling, general and administrative expenses			2,968					3,518
Other income, net			(25	)				(3	)
Operating loss (income)			(81	)				6,733
Financial expenses, net			233					329
Share in net loss of associated companies			15					-
Loss from continuing operation before income taxes			167					7,062
Tax income			(2	)				(47	)
Net loss from continuing operation			165					7,015
Net income from discontinued operations, net of tax			-					(76,465	)
Net loss (income)			165					(69,450	)
Net loss (income) attributable to non-controlling interests from continuing operation			54					(39	)
Net loss attributable to non-controlling interests from discontinued operations			-					(492	)
Net loss (income) attributable to Orgenesis Inc.			219					(69,981	)
Loss (Earning) per share:
Basic and diluted from continuing operations		$	0.01				$	0.39
Basic and diluted from discontinued operations		$	-				$	(4.62	)
Basic and diluted		$	0.01				$	(4.23	)
Weighted average number of shares used in computation of Basic and Diluted loss per share:
Basic and diluted			24,189,175					17,780,830
Comprehensive loss (income):
Net loss from Continuing Operation		$	165				$	7,015
Net income from Discontinued Operations, Net of Tax			-					(76,465	)
Other Comprehensive loss – Translation adjustment			277					644
Release of translation adjustment due to sale of subsidiary			-					(194	)
Comprehensive loss (income)			442					(69,000	)
Comprehensive loss (income) attributed to non-controlling interests from continuing operation			54					(39	)
Comprehensive income attributed to non-controlling interests from discontinued operation			-					(492	)
Comprehensive loss (income) attributed to Orgenesis Inc.		$	496				$	(69,531	)