Orgenesis Provides Third Quarter 2024 Business Update
13 Noviembre 2024 - 7:00AM
Orgenesis Inc.
(OTCQX:
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 third quarter
ended September 30, 2024.
Vered Caplan, CEO of Orgenesis, stated,
“Orgenesis is making significant progress in redefining
accessibility to cell and gene therapies through our decentralized
approach. This model is designed to expedite capacity setup,
enhance production efficiency, and reduce treatment costs. We are
dedicated to expanding our clinical initiatives and deepening
global partnerships, creating a scalable and cost-effective pathway
to advanced therapies. Our goal is to bring these innovative
solutions to patients worldwide, focusing on sustainable growth and
pioneering advancements in cell and gene therapies.
“In addition, as we previously disclosed, a
recent real-world study of our CD19 CAR-T therapy, ORG-101,
demonstrated efficacy and a favorable safety profile. ORG-101
achieved an 82% complete response rate in adults and a 93% complete
response rate in pediatric patients with CD19+ Acute Lymphoblastic
Leukemia, alongside a lower incidence of severe Cytokine Release
Syndrome, 2% in adults and 6% in pediatric patients, compared to
conventional CAR-T therapies. Beyond these positive clinical
outcomes, we believe that the production data further validates
Orgenesis’ decentralized approach as a cost-effective way to make
CAR-T therapies more affordable and accessible globally.
Additionally, we are excited to announce that we are initiating a
Phase 1/2 multicenter clinical study of ORG-101 CAR-T therapy at
the University General Hospital of Patras and "George Papanikolaou"
General Hospital of Thessaloniki, in Greece, supported by the
awarded grant by ‘Enterprise Greece’, with plans to expand to
additional hospitals within our partnership network.
“We now offer hospitals, and research centers a
unique partnership that enables a swift and cost-efficient way to
build up their capacity and capability to provide cell and gene
therapy products to their patients. Our decentralized platforms for
various indications are quick to deploy and minimize the cost of
production. We continue to be supported by strategic partners and
government grants who share our goal of making cell and gene
therapies available to all.
“Our strategic joint venture with Harley Street
Healthcare Group (HSHG) is an additional angle of this approach,
aimed at utilizing the know-how and technologies that we have
developed for treatment of cancer and for the prevention of disease
targeting the wellness and longevity sector. By combining our cell
and gene therapy innovations with HSHG’s established healthcare
network, we expect to introduce a suite of longevity and wellness
services, targeting key markets such as the UK, UAE, and Canada.
This partnership positions us to drive impactful healthcare
innovations that can improve quality of life and longevity across
diverse regions.”
The complete financial results for the third
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
ORGENESIS INC.CONDENSED
CONSOLIDATED BALANCE SHEETS(U.S. Dollars, in
thousands)(Unaudited) |
|
|
As of |
|
|
September 30, 2024 |
|
|
December 31,2023 |
Assets |
|
|
|
|
|
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
Cash and cash equivalents |
$ |
204 |
|
$ |
837 |
Restricted cash |
|
918 |
|
|
642 |
Accounts receivable, net of credit losses of $14,397 as of
September 30, 2024 ($0 as of December 31, 2023) |
|
161 |
|
|
88 |
Prepaid expenses and other receivables |
|
1,236 |
|
|
2,017 |
Receivables from related parties |
|
- |
|
|
458 |
Inventory |
|
- |
|
|
34 |
Total current assets |
|
2,519 |
|
|
4,076 |
|
|
|
|
|
|
NON-CURRENT ASSETS: |
|
|
|
|
|
Deposits |
$ |
55 |
|
$ |
38 |
Investments to associates |
|
8 |
|
|
8 |
Property, plant and equipment, net |
|
14,901 |
|
|
1,475 |
Intangible assets, net |
|
8,528 |
|
|
7,375 |
Operating lease right-of-use assets |
|
2,121 |
|
|
351 |
Goodwill |
|
1,211 |
|
|
1,211 |
Other assets |
|
344 |
|
|
18 |
Total non-current assets |
|
27,168 |
|
|
10,476 |
TOTAL ASSETS |
$ |
29,687 |
|
$ |
14,552 |
|
|
|
|
|
|
ORGENESIS INC.CONDENSED
CONSOLIDATED BALANCE SHEETS(U.S. Dollars, in
thousands)(Unaudited) |
|
|
As of |
|
|
September 30, 2024 |
|
|
December 31, 2023 |
Liabilities and Equity |
|
|
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
Accounts payable |
$ |
11,338 |
|
|
$ |
6,451 |
|
Accounts payable related parties |
|
2,699 |
|
|
|
133 |
|
Advance payments from Germfree (see note 11a) |
|
6,720 |
|
|
|
- |
|
Accrued expenses and other payables |
|
2,690 |
|
|
|
2,218 |
|
Income tax payable |
|
784 |
|
|
|
740 |
|
Employees and related payables |
|
1,853 |
|
|
|
1,079 |
|
Other payables related parties |
|
- |
|
|
|
52 |
|
Advance payments on account of grant |
|
2,771 |
|
|
|
2,180 |
|
Short-term loans |
|
4,905 |
|
|
|
650 |
|
Current maturities of finance leases |
|
46 |
|
|
|
18 |
|
Current maturities of operating leases |
|
277 |
|
|
|
216 |
|
Short-term and current maturities of convertible loans |
|
1,966 |
|
|
|
2,670 |
|
Total current liabilities |
|
36,049 |
|
|
|
16,407 |
|
|
|
|
|
|
|
LONG-TERM LIABILITIES: |
|
|
|
|
|
Non-current operating leases |
$ |
1,839 |
|
|
$ |
96 |
|
Loans payable |
|
2,828 |
|
|
|
- |
|
Convertible loans |
|
5,435 |
|
|
|
18,967 |
|
Retirement benefits obligation |
|
101 |
|
|
|
- |
|
Finance leases |
|
1 |
|
|
|
4 |
|
Contingent consideration (see note 4) |
|
4,906 |
|
|
|
- |
|
Other long-term liabilities |
|
2,456 |
|
|
|
61 |
|
Total long-term liabilities |
|
17,566 |
|
|
|
19,128 |
|
TOTAL LIABILITIES |
|
53,615 |
|
|
|
35,535 |
|
|
|
|
|
|
|
CAPITAL DEFICIENCY:Common stock of $0.0001 par
value:Authorized at September 30, 2024 and December 31, 2023:
14,583,333 shares; Issued at September 30, 2024 and December 31,
2023: 4,799,323 and 3,216,363 shares, respectively; Outstanding at
September 30, 2024 and December 31, 2023: 4,770,666 and 3,187,706
shares, respectively |
|
5 |
|
|
|
3 |
|
Additional paid-in capital |
|
181,991 |
|
|
|
156,837 |
|
Accumulated other comprehensive income (loss) |
|
(215 |
) |
|
|
65 |
|
Treasury stock 28,656 shares as of September 30, 2024 and December
31, 2023 |
|
(1,266 |
) |
|
|
(1,266 |
) |
Accumulated deficit |
|
(204,411 |
) |
|
|
(176,622 |
) |
Equity attributable to Orgenesis Inc. |
|
(23,896 |
) |
|
|
(20,983 |
) |
Non-controlling interest |
|
(32 |
) |
|
|
- |
|
TOTAL CAPITAL DEFICIENCY |
|
(23,928 |
) |
|
|
(20,983 |
) |
TOTAL LIABILITIES AND CAPITAL DEFICIENCY |
$ |
29,687 |
|
|
$ |
14,552 |
|
|
|
|
|
|
|
|
|
ORGENESIS INC.CONDENSED CONSOLIDATED
STATEMENTS OF LOSS AND COMPREHENSIVE LOSS(U.S.
Dollars, in thousands, except share and per share
amounts)(Unaudited) |
|
Three Months Ended |
|
Nine Months Ended |
|
September 30,2024 |
|
September 30,2023 |
|
September 30,2024 |
|
September 30,2023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
$ |
347 |
|
|
$ |
110 |
|
|
$ |
734 |
|
|
$ |
365 |
|
Cost of revenues |
|
585 |
|
|
|
139 |
|
|
|
1,615 |
|
|
|
6,093 |
|
Gross profit (loss) |
|
(238 |
) |
|
|
(29 |
) |
|
|
(881 |
) |
|
|
(5,728 |
) |
Cost of development services and research and development
expenses |
|
4,523 |
|
|
|
808 |
|
|
|
8,382 |
|
|
|
7,616 |
|
Amortization of intangible assets |
|
196 |
|
|
|
153 |
|
|
|
575 |
|
|
|
568 |
|
Change in contingent consideration |
|
81 |
|
|
|
- |
|
|
|
263 |
|
|
|
- |
|
Selling, general and administrative expenses including credit
losses of $ 2,725 for the nine months ended September 30, 2024 and
$0 for the three months ended September 30, 2024 and $24,367 for
the nine months ended September 30, 2023 and $0 for the three
months ended September 30, 2023 |
|
2,664 |
|
|
|
1,245 |
|
|
|
10,781 |
|
|
|
32,989 |
|
Impairment expenses on Property, plant and equipment |
|
692 |
|
|
|
- |
|
|
|
692 |
|
|
|
- |
|
Operating loss |
|
8,394 |
|
|
|
2,235 |
|
|
|
21,574 |
|
|
|
46,901 |
|
Loss from deconsolidation of OBI and Octomera (see note 4) |
|
- |
|
|
|
- |
|
|
|
66 |
|
|
|
5,343 |
|
Other income (expense), net |
|
122 |
|
|
|
(2 |
) |
|
|
114 |
|
|
|
(4 |
) |
Credit loss on convertible loan receivable |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,688 |
|
Loss from extinguishment in connection with convertible loan |
|
- |
|
|
|
- |
|
|
|
141 |
|
|
|
283 |
|
Financial expenses, net |
|
718 |
|
|
|
545 |
|
|
|
2,385 |
|
|
|
1,918 |
|
Convertible loans induced conversion expenses |
|
- |
|
|
|
- |
|
|
|
4,304 |
|
|
|
- |
|
Share in net loss of associated companies |
|
- |
|
|
|
553 |
|
|
|
- |
|
|
|
552 |
|
Loss before income taxes |
|
9,234 |
|
|
|
3,331 |
|
|
|
28,584 |
|
|
|
57,681 |
|
Tax expenses |
|
32 |
|
|
|
394 |
|
|
|
53 |
|
|
|
614 |
|
Net loss |
|
9,266 |
|
|
|
3,725 |
|
|
|
28,637 |
|
|
|
58,295 |
|
Net loss attributable to non-controlling interests (including
redeemable) |
|
(146 |
) |
|
|
- |
|
|
|
(848 |
) |
|
|
(9,557 |
) |
Net loss attributable to Orgenesis Inc. |
$ |
9,120 |
|
|
$ |
3,725 |
|
|
$ |
27,789 |
|
|
$ |
48,738 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share: |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
$ |
1.93 |
|
|
$ |
0.123 |
|
|
$ |
7.06 |
|
|
$ |
1.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares used in computation of
Basic and Diluted loss per share: |
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
4,715,229 |
|
|
|
3,002,259 |
|
|
|
3,938,419 |
|
|
|
2,868,078 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
9,266 |
|
|
$ |
3,725 |
|
|
$ |
28,637 |
|
|
$ |
58,295 |
|
Other comprehensive loss (income) - translation adjustments |
|
517 |
|
|
|
(9 |
) |
|
|
280 |
|
|
|
43 |
|
Release of translation adjustment due to deconsolidation of
Octomera |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(384 |
) |
Comprehensive loss |
|
9,783 |
|
|
|
3,716 |
|
|
|
28,917 |
|
|
|
57,954 |
|
Comprehensive income (loss) attributed to non-controlling
interests |
|
(146 |
) |
|
|
- |
|
|
|
(848 |
) |
|
|
(9,557 |
) |
Comprehensive loss attributed to Orgenesis Inc. |
$ |
9,637 |
|
|
$ |
3,716 |
|
|
$ |
28,069 |
|
|
$ |
48,397 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Orgenesis (NASDAQ:ORGS)
Gráfica de Acción Histórica
De Nov 2024 a Dic 2024
Orgenesis (NASDAQ:ORGS)
Gráfica de Acción Histórica
De Dic 2023 a Dic 2024