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 servicebusiness, 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
(tables follow)
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
