Orgenesis Provides Second Quarter 2024 Business Update
09 8월 2024 - 5:05AM
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 OrgenesisOrgenesis 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, LLCTel: 212-671-1021Orgs@crescendo-ir.com
Communications contact for
OrgenesisIB CommunicationsMichelle BoxallTel +44 (0)20
8943 4685michelle@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 |
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 |
|
Orgenesis (NASDAQ:ORGS)
과거 데이터 주식 차트
부터 11월(11) 2024 으로 12월(12) 2024
Orgenesis (NASDAQ:ORGS)
과거 데이터 주식 차트
부터 12월(12) 2023 으로 12월(12) 2024