Orgenesis Provides Second Quarter 2024 Business Update

Rhea-AI Summary

Orgenesis Inc. (NASDAQ: ORGS), a global biotech company focused on cell and gene therapies (CGT), provided a business update for Q2 2024. The company has acquired GMP-validated platforms for producing CAR-T, tumor-infiltrating lymphocytes, lentivirus vectors, oncolytic virus cell carriers, and therapeutic exosomes. CEO Vered Caplan highlighted the integration of their robust cell therapy production capabilities with their wide range of therapies developed through partnerships. Orgenesis now offers hospitals and partners both services for their own development and products, as well as the opportunity to benefit from Orgenesis' proprietary therapies. The company plans to use the newly acquired platform to supply its own CAR-T cell products, aiming to provide a comprehensive solution for the industry, including hospitals and researchers worldwide.

Positive

• Acquired GMP-validated platforms for multiple cell and gene therapy products
• Integration of cell therapy production capabilities with proprietary therapies
• Expansion of offerings to include both services and proprietary products
• Plans to supply own CAR-T cell products using newly acquired platform

Negative

• None.

Insights

Biotech Industry Analyst

Orgenesis's recent acquisition of GMP-validated platforms for various cell and gene therapies marks a significant strategic shift. This move integrates their production capabilities with proprietary therapies, potentially streamlining the CGT development process. The focus on decentralized production could address key industry challenges like manufacturing scalability and accessibility.

However, the lack of financial details or specific therapy progress updates in this release is concerning. The company's ability to monetize these new capabilities and compete in the crowded CGT space remains uncertain. Investors should closely monitor upcoming updates for concrete evidence of commercial traction and regulatory progress.

Healthcare Investment Strategist

Orgenesis's strategic pivot towards offering both services and proprietary therapies is intriguing but comes with significant execution risks. The integration of centralized and decentralized platforms could potentially create a unique market position, addressing the industry's need for flexible, scalable manufacturing solutions.

However, the company's financial health and burn rate are critical factors not addressed in this update. The CGT sector is capital-intensive and without clear revenue projections or funding details, it's challenging to assess Orgenesis's long-term viability. Investors should seek clarity on the company's cash position, revenue model and timeline to market for these new therapeutic platforms before making investment decisions.

Acquired GMP-validated platforms for launching proprietary CAR-T, tumor-infiltrating lymphocytes, lentivirus vectors, oncolytic virus cell carriers, and therapeutic exosomes

GERMANTOWN, Md., Aug. 08, 2024 (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) in order to improve access and outcomes in healthcare, today provided a business update for the second quarter ended June 30, 2024.

Vered Caplan, CEO of Orgenesis, stated, “After more than a decade of parallel efforts—on one hand, establishing robust capabilities in cell therapy production by initially serving the industry in a centralized manner and later integrating these capabilities into a decentralized platform, and on the other, forming partnerships through joint ventures and licenses to develop a wide range of therapies—we have finally reached the point where we can integrate these two paths. We are now offering hospitals and partners not only our services for their own development and products but also the opportunity to benefit from our own proprietary therapies. We recently completed the acquisition of GMP-validated platforms for producing CAR-T, tumor-infiltrating lymphocytes, lentivirus vectors, oncolytic virus cell carriers, and therapeutic exosomes—and we intend to utilize this platform to supply our own CAR-T cell products. We are proud to introduce these potential breakthrough therapies and processes, which we believe can elevate our decentralized platform by providing a comprehensive solution for the industry, including hospitals and researchers around the world. We look forward to providing further updates on key initiatives underway in the weeks and months ahead.”

The complete financial results for the second 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

Communications contact for Orgenesis
IB Communications
Michelle Boxall
Tel +44 (0)20 8943 4685
michelle@ibcomms.agency

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ORGENESIS INC. CONSOLIDATED BALANCE SHEETS (U.S. Dollars, in thousands)
		As of
		June 30, 2024			December 31, 2023
Assets
CURRENT ASSETS:

 

Cash and cash equivalents	$	77		$	837
Restricted cash		1,079			642
Accounts receivable, net of credit losses of $29,234 as of June 30, 2024 ($0 as of December 31, 2023)		240			88
Prepaid expenses and other receivables		952			2,017
Receivable from related parties		-			458
Inventory		-			34
Total current assets		2,348			4,076

 

NON-CURRENT ASSETS:

 

Deposits	$	249		$	38
Investments to associates		8			8
Property, plant and equipment, net		15,901			1,475
Intangible assets, net		8,724			7,375
Operating lease right-of-use assets		1,805			351
Goodwill		1,211			1,211
Other assets		331			18
Total non-current assets		28,229			10,476
TOTAL ASSETS	$	30,577		$	14,552

 

CONSOLIDATED BALANCE SHEETS (U.S. Dollars, in thousands)
		As of
		June 30, 2024				December 31, 2023
Liabilities net of (Capital Deficiency)
CURRENT LIABILITIES:

 

Accounts payable	$	10,717			$	6,451
Accounts payable related Parties		2,696				133
Advance payments from Germfree (See note 11a)		6,720				-
Accrued expenses and other payables		2,789				2,218
Income tax payable		767				740
Employees and related payables		1,634				1,079
Other payable related parties		-				52
Advance payments on account of grant		2,733				2,180
Short-term loans		1,186				650
Current maturities of finance leases		62				18
Current maturities of operating leases		465				216
Short-term and current maturities of convertible loans		1,931				2,670
TOTAL CURRENT LIABILITIES		31,700				16,407

 

LONG-TERM LIABILITIES:
Non-current operating leases	$	1,318			$	96
Loans payable		2,762				-
Convertible loans		5,296				18,967
Retirement benefits obligation		96				-
Finance leases		1				4
Contingent consideration (see note 4)		4,825				-
Other long-term liabilities		371				61
TOTAL LONG-TERM LIABILITIES		14,669				19,128
TOTAL LIABILITIES		46,369				35,535

 

CAPITAL DEFICIENCY:
Common stock of $0.0001 par value: Authorized at June 30, 2024 and December 31, 2023: 145,833,334 shares; Issued at June 30, 2024 and December 31, 2023: 47,212,473 and 32,163,630 shares, respectively; Outstanding at June 30, 2024 and December 31, 2023: 46,925,906 and 31,877,063 shares, respectively	$	5			$	3
Additional paid-in capital		180,752				156,837
Accumulated other comprehensive income		302				65
Treasury stock 286,567 shares as of June 30, 2024 and December 31, 2023		(1,266)				(1,266)
Accumulated deficit		(195,291)				(176,622)
Equity attributable to Orgenesis Inc.		(15,498)				(20,983)
Non-controlling interest		(294)				-
TOTAL CAPITAL DEFICIENCY		(15,792)				(20,983)
TOTAL LIABILITIES AND CAPITAL DEFICIENCY	$	30,577			$	14,552

 

ORGENESIS INC. CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (U.S. Dollars, in thousands, except share and per share amounts)
	Three Months Ended					Six Months Ended
		June 30, 2024		June 30, 2023			June 30, 2024		June 30, 2023

 

Revenues	$	246			$	113			$	387			$	255
Cost of revenues		538				3,232				1,030				5,954
Gross profit		(292	)			(3,119	)			(643	)			(5,699	)
Cost of development services and research and development expenses		1,489				3,527				3,859				6,808
Amortization of intangible assets		226				208				379				415
Change in Contingent consideration		182				-				182				-
Selling, general and administrative expenses including credit losses of $2,725 for the six months ended June 30, 2024 and $(500) for the three months ended June 30, 2024 and $24,367 for the six months ended June 30, 2023 and $14,878 for the three months ended June 30, 2023		2,061				18,216				8,117				31,744
Operating loss		4,250				25,070				13,180				44,666
Loss from deconsolidation of OBI and Octomera (see note 4)		-				5,343				66				5,343
Other income, net		(8	)			-				(8	)			(2	)
Credit loss on convertible loan receivable		-				-				-				2,688
Loss from extinguishment in connection with convertible loan		-				-				141				283
Financial expenses, net		815				692				1,667				1,373
Convertible loans induced conversion expenses		4,304				-				4,304				-
Share in net loss profit of associated companies		-				(3	)			-				(1	)
Loss before income taxes		9,361				31,102				19,350				54,350
Tax expenses		5				91				21				220
Net loss		9,366				31,193				19,371				54,570
Net loss attributable to non-controlling interests (including redeemable)		(462	)			(5,650	)			(702	)			(9,557	)
Net loss attributable to Orgenesis Inc.	$	8,904			$	25,543			$	18,669			$	45,013

 

Loss per share:
Basic and diluted	$	0.23			$	0.76			$	0.52			$	1.63
Weighted average number of shares used in computation of Basic and Diluted loss per share:
Basic and diluted		38,860,727				28,603,597				35,979,567				27,546,229
Comprehensive loss:
Net loss	$	9,366			$	31,193			$	19,371			$	54,570
Other comprehensive loss (income) - translation adjustments		(176	)			11				(237	)			52
Release of translation adjustment due to deconsolidation of Octomera		-				(384	)			-				(384	)
Comprehensive loss		9,190				30,820				19,134				54,238
Comprehensive loss attributed to non-controlling interests		(462	)			(5,650	)			(702	)			(9,557	)
Comprehensive loss attributed to Orgenesis Inc.	$	8,728			$	25,170			$	18,432			$	44,681

FAQ

What GMP-validated platforms did Orgenesis (ORGS) acquire in Q2 2024?

Orgenesis acquired GMP-validated platforms for producing CAR-T, tumor-infiltrating lymphocytes, lentivirus vectors, oncolytic virus cell carriers, and therapeutic exosomes.

How does Orgenesis (ORGS) plan to use its newly acquired platforms?

Orgenesis plans to utilize the newly acquired platforms to supply its own CAR-T cell products and provide a comprehensive solution for the industry, including hospitals and researchers worldwide.

What new offerings did Orgenesis (ORGS) announce for hospitals and partners in Q2 2024?

Orgenesis announced that it now offers hospitals and partners both services for their own development and products, as well as the opportunity to benefit from Orgenesis' proprietary therapies.

What is the significance of Orgenesis (ORGS) integrating its cell therapy production capabilities with its partnerships?

The integration allows Orgenesis to offer a more comprehensive solution, combining robust production capabilities with a wide range of therapies developed through partnerships, potentially elevating their decentralized platform in the cell and gene therapy industry.