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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ | QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the Quarterly Period Ended September 30, 2024
or
☐ | TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the Transition Period from ___________ to ___________
Commission
file number: 001-38416
ORGENESIS
INC.
(Exact
name of registrant as specified in its charter)
Nevada |
|
98-0583166 |
(State or other jurisdiction of
incorporation or organization) |
|
(I.R.S. Employer
Identification No.) |
20271
Goldenrod Lane
Germantown,
MD 20876
(Address
of principal executive offices) (Zip Code)
(480)
659-6404
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
symbols(s) |
|
Name
of each exchange on which registered |
Common
Stock |
|
ORGS |
|
* |
*
On October 17, 2024, the Nasdaq Stock Market (“Nasdaq”) notified Orgenesis Inc. (the “Company”) that it plans
to file a notification of removal from listing (Form 25) with the Securities and Exchange Commission (the “SEC”) to delist
the Company’s common stock from Nasdaq upon the completion of all applicable procedures. After the Form 25 is filed by Nasdaq,
the delisting will become effective 10 days later. The deregistration of the Company’s common stock under Section 12(b) of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”), will occur 90 days following the filing of the Form 25,
or such shorter period as the SEC may determine. Upon deregistration of the Company’s common stock under Section 12(b) of the Exchange
Act, the Company’s common stock will remain registered under Section 12(g) of the Exchange Act. The Company’s common stock
began trading on the OTCQX operated by the OTC Markets Group, Inc. beginning on October 21, 2024.
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Yes
☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files).
Yes
☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
|
Emerging
growth company |
☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of November 13, 2024, there were 5,169,248 shares of registrant’s common stock outstanding.
ORGENESIS
INC.
FORM
10-Q
FOR
THE NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023
TABLE
OF CONTENTS
PART
I –FINANCIAL INFORMATION
Item
1. Financial Statements
ORGENESIS
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(U.S.
Dollars in thousands)
(Unaudited)
| |
September
30, 2024 | | |
December
31, 2023 | |
| |
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 | |
Receivable 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 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ORGENESIS
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS (Continued)
(U.S.
Dollars, in thousands, except share and per share amounts)
(Unaudited)
| |
As
of | |
| |
September
30, 2024 | | |
December
31, 2023 | |
Liabilities net of (Capital
Deficiency) | |
| | | |
| | |
| |
| | | |
| | |
CURRENT LIABILITIES: | |
| | | |
| | |
Accounts payable | |
$ | 11,338 | | |
$ | 6,451 | |
Accounts payable related
Parties | |
| 2,699 | | |
| 133 | |
Accounts payable | |
| 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 payable 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 | |
| (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 | |
*The above share information has been adjusted
to reflect the reverse stock split as discussed in Note 1.
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ORGENESIS
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(U.S.
Dollars in thousands, except share and loss per share amounts)
(Unaudited)
| |
| September
30, 2024 | | |
| September
30, 2023 | | |
| September
30, 2024 | | |
| September
30, 2023 | |
| |
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 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 profit of associated companies | |
| - | | |
| 553 | | |
| - | | |
| 552 | |
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 | | |
$ | 0.12 | | |
$ | 7.06 | | |
$ | 1.70 | |
| |
| | | |
| | | |
| | | |
| | |
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 loss attributed to non-controlling interests | |
| (146 | ) | |
| - | | |
| (848 | ) | |
| (9,557 | ) |
| |
| | | |
| | | |
| | | |
| | |
Comprehensive loss attributed to Orgenesis Inc. | |
$ | 9,637 | | |
$ | 3,716 | | |
$ | 28,069 | | |
$ | 48,397 | |
*The above share information has been adjusted to reflect the reverse stock
split as discussed in Note 1.
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ORGENESIS
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(U.S.
Dollars in thousands, except share amounts)
(Unaudited)
| |
Number | | |
Par Value | | |
Additional Paid-in Capital | | |
Accumulated Other Comprehensive Income (Loss) | | |
Treasury
Shares | | |
Accumulated Deficit | | |
Equity Attributed to Orgenesis Inc. | | |
Non- Controlling Interest | | |
Total | |
| |
Common
Stock | | |
| | |
| | |
| | |
| | |
| | |
| |
| |
Number | | |
Par Value | | |
Addi-tional Paid-in Capital | | |
Accumu-lated Other Compre-hensive Income (Loss) | | |
Treasury
Shares | | |
Accumu-lated Deficit | | |
Equity Attri-buted to Orgenesis Inc. | | |
Non- Contro- lling Interest | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance at January
1, 2024 | |
| 3,187,588 | | |
$ | 3 | | |
$ | 156,837 | | |
$ | 65 | | |
$ | (1,266 | ) | |
$ | (176,622 | ) | |
$ | (20,983 | ) | |
$ | - | | |
$ | (20,983 | ) |
Changes during the nine months
ended September 30, 2024: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| - | | |
| - | | |
| 304 | | |
| - | | |
| - | | |
| - | | |
| 304 | | |
| - | | |
| 304 | |
RSUs vested | |
| 9,949 | | |
| -* | | |
| - | | |
| - | | |
| - | | |
| - | | |
| -* | | |
| - | | |
| -* | |
Exercise of options | |
| 25,519 | | |
| -* | | |
| 13 | | |
| - | | |
| - | | |
| - | | |
| 13 | | |
| - | | |
| 13 | |
Issuance of shares to service
providers | |
| 116,400 | | |
| - | | |
| 1,506 | | |
| - | | |
| - | | |
| - | | |
| 1,506 | | |
| - | | |
| 1,506 | |
Exchange of convertible loans
for equity | |
| 1,182,913 | | |
| 1 | | |
| 20,310 | | |
| - | | |
| - | | |
| - | | |
| 20,311 | | |
| - | | |
| 20,311 | |
Issuance of warrants with respect
to loans (see note7) | |
| - | | |
| | | |
| 745 | | |
| - | | |
| - | | |
| - | | |
| 745 | | |
| - | | |
| 745 | |
Extinguishment in connection
with convertible loan restructuring | |
| - | | |
| - | | |
| 141 | | |
| - | | |
| - | | |
| - | | |
| 141 | | |
| - | | |
| 141 | |
Issuance of shares and warrants | |
| 242,272 | | |
| -* | | |
| 2,496 | | |
| - | | |
| - | | |
| - | | |
| 2,496 | | |
| - | | |
| 2,496 | |
NCI arising from Octomera reconsolidation | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 408 | | |
| 408 | |
Transaction with NCI (see
note11b) | |
| - | | |
| - | | |
| (408 | ) | |
| - | | |
| - | | |
| - | | |
| (408 | ) | |
| 408 | | |
| - | |
Issuance of shares due to exercise of warrants | |
| 6,026 | | |
| 1 | | |
| 47 | | |
| - | | |
| - | | |
| - | | |
| 48 | | |
| - | | |
| 48 | |
Comprehensive
loss for the period | |
| - | | |
| - | | |
| - | | |
| (280 | ) | |
| - | | |
| (27,789 | ) | |
| (28,069 | ) | |
| (848 | ) | |
| (28,917 | ) |
Balance
at September 30, 2024 | |
| 4,770,667 | | |
$ | 5 | | |
$ | 181,991 | | |
$ | (215 | ) | |
$ | (1,266 | ) | |
$ | (204,411 | ) | |
$ | (23,896 | ) | |
$ | (32 | ) | |
$ | (23,928 | ) |
* | |
** | All share amounts have been retroactively adjusted to reflect a 1-for-10
reverse share split (Note 1) |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ORGENESIS
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(U.S.
Dollars in thousands, except share amounts)
(Unaudited)
| |
Common
Stock | | |
| | |
| | |
| | |
| | |
| | |
| |
| |
Number | | |
Par Value | | |
Addi-
tional Paid-in Capital | | |
Accumulated Other Compre-
hensive Income
(Loss) | | |
Treasury
Shares | | |
Accumu-
lated Deficit | | |
Equity Attri-
buted to Orgenesis Inc. | | |
Non- Contro-
lling Interest | | |
Total | |
Balance at January
1, 2023 | |
| 2,554,455 | | |
$ | 3 | | |
$ | 150,355 | | |
$ | (270 | ) | |
$ | (1,266 | ) | |
$ | (121,261 | ) | |
$ | 27,561 | | |
$ | 1,510 | | |
$ | 29,071 | |
Changes during the nine months
ended September 30, 2023: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| - | | |
| - | | |
| 387 | | |
| - | | |
| - | | |
| - | | |
| 387 | | |
| - | | |
| 387 | |
Issuance of shares and warrants
net of issuance costs | |
| 394,739 | | |
| -* | | |
| 4,341 | | |
| - | | |
| - | | |
| - | | |
| 4,341 | | |
| - | | |
| 4,341 | |
Issuance of shares due to exercise of warrants | |
| 97,368 | | |
| -* | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Issuance of warrants with respect
to convertible loans | |
| - | | |
| - | | |
| 449 | | |
| - | | |
| - | | |
| - | | |
| 449 | | |
| - | | |
| 449 | |
Extinguishment in connection
with convertible loan restructuring | |
| - | | |
| - | | |
| 287 | | |
| - | | |
| - | | |
| - | | |
| 287 | | |
| - | | |
| 287 | |
Deconsolidation of Octomera | |
| - | | |
| - | | |
| 9,406 | | |
| 384 | | |
| - | | |
| - | | |
| 9,790 | | |
| (1,360 | ) | |
| 8,430 | |
Adjustment to redemption value
of redeemable non-controlling interest | |
| - | | |
| - | | |
| (9,406 | ) | |
| - | | |
| - | | |
| - | | |
| (9,406 | ) | |
| - | | |
| (9,406 | ) |
Comprehensive
loss for the period | |
| - | | |
| - | | |
| - | | |
| (43 | ) | |
| - | | |
| (48,738 | ) | |
| (48,781 | ) | |
| (150 | ) | |
| (48,931 | ) |
Balance
at September 30, 2023 | |
| 3,046,562 | | |
$ | 3 | | |
$ | 155,819 | | |
$ | 71 | | |
$ | (1,266 | ) | |
$ | (169,999 | ) | |
$ | (15,372 | ) | |
$ | - | | |
$ | (15,372 | ) |
* | |
** | All share amounts have been retroactively adjusted to reflect a 1-for-10
reverse share split (Note 1) |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ORGENESIS
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(U.S.
Dollars in thousands, except share amounts)
(Unaudited)
| |
Common
Stock | | |
| | |
| | |
| | |
| | |
| | |
| |
| |
Number | | |
Par Value | | |
Addi-tional Paid-in Capital | | |
Accumu-lated Other Compre-hensive Income
(loss) | | |
Treasury
Shares | | |
Accumu-lated Deficit | | |
Equity Attri-buted to Orgenesis Inc. | | |
Non- Contro-lling Interest | | |
Total | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
Balance at
July 1, 2024 | |
| 4,692,473 | | |
$ | 5 | | |
$ | 180,752 | | |
$ | 302 | | |
$ | (1,266 | ) | |
$ | (195,291 | ) | |
$ | (15,498 | ) | |
$ | (294 | ) | |
$ | (15,792 | ) |
Changes during the three months
ended September 30, 2024: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation | |
| - | | |
| - | | |
| 89 | | |
| - | | |
| - | | |
| - | | |
| 89 | | |
| - | | |
| 89 | |
RSUs vested | |
| 1,649 | | |
| -* | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | |
Exercise of options | |
| 23,019 | | |
| -* | | |
| -* | | |
| - | | |
| - | | |
| - | | |
| -* | | |
| - | | |
| -* | |
Issuance of shares to service
providers | |
| 50,000 | | |
| -* | | |
| 816 | | |
| - | | |
| - | | |
| - | | |
| 816 | | |
| - | | |
| 816 | |
Issuance of warrants with respect
to loans (see note 7) | |
| - | | |
| - | | |
| 714 | | |
| - | | |
| - | | |
| - | | |
| 714 | | |
| - | | |
| 714 | |
Transaction with NCI (see
note 11b) | |
| - | | |
| - | | |
| (408 | ) | |
| - | | |
| - | | |
| - | | |
| (408 | ) | |
| 408 | | |
| - | |
Issuance of shares due to exercise of warrants | |
| 3,526 | | |
| -* | | |
| 28 | | |
| - | | |
| - | | |
| - | | |
| 28 | | |
| - | | |
| 28 | |
Comprehensive
loss for the period | |
| - | | |
| - | | |
| - | | |
| (517 | ) | |
| - | | |
| (9,120 | ) | |
| (9,637 | ) | |
| (146 | ) | |
| (9,783 | ) |
Balance
at September 30, 2024 | |
| 4,770,667 | | |
$ | 5 | | |
$ | 181,991 | | |
$ | (215 | ) | |
$ | (1,266 | ) | |
$ | (204,411 | ) | |
$ | (23,896 | ) | |
$ | (32 | ) | |
$ | (23,928 | ) |
* | |
** | All share amounts have been retroactively adjusted to reflect a 1-for-10
reverse share split (Note 1) |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ORGENESIS
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(U.S.
Dollars in thousands, except share amounts)
(Unaudited)
| |
Common
Stock | | |
| | |
| | |
| | |
| | |
| | |
| |
| |
Number | | |
Par Value | | |
Addi-tional Paid-in Capital | | |
Accumulated Other Compre-hensive Income | | |
Treasury
Shares | | |
Accumu-lated Deficit | | |
Equity Attri-buted to Orgenesis Inc. | | |
Non- Contro-lling Interest | | |
Total | |
Balance at
July 1, 2023 | |
| 2,846,562 | | |
$ | 3 | | |
$ | 154,743 | | |
$ | 62 | | |
$ | (1,266 | ) | |
$ | (166,274 | ) | |
$ | (12,732 | ) | |
$ | - | | |
$ | (12,732 | ) |
Balance | |
| 2,846,562 | | |
$ | 3 | | |
$ | 154,743 | | |
$ | 62 | | |
$ | (1,266 | ) | |
$ | (166,274 | ) | |
$ | (12,732 | ) | |
$ | - | | |
$ | (12,732 | ) |
Changes during the three months
ended September 30, 2023: | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Stock-based compensation to
employees and directors | |
| - | | |
| - | | |
| 76 | | |
| - | | |
| - | | |
| - | | |
| 76 | | |
| - | | |
| 76 | |
Stock-based compensation | |
| - | | |
| - | | |
| 76 | | |
| - | | |
| - | | |
| - | | |
| 76 | | |
| - | | |
| 76 | |
Issuance of shares | |
| 200,000 | | |
| -* | | |
| 1,000 | | |
| - | | |
| - | | |
| - | | |
| 1,000 | | |
| - | | |
| 1,000 | |
Comprehensive
income (loss) for the period | |
| - | | |
| - | | |
| - | | |
| 9 | | |
| - | | |
| (3,725 | ) | |
| (3,716 | ) | |
| - | | |
| (3,716 | ) |
Balance
at September 30, 2023 | |
| 3,046,562 | | |
$ | 3 | | |
$ | 155,819 | | |
$ | 71 | | |
$ | (1,266 | ) | |
$ | (169,999 | ) | |
$ | (15,372 | ) | |
$ | - | | |
$ | (15,372 | ) |
Balance
| |
| 3,046,562 | | |
$ | 3 | | |
$ | 155,819 | | |
$ | 71 | | |
$ | (1,266 | ) | |
$ | (169,999 | ) | |
$ | (15,372 | ) | |
$ | - | | |
$ | (15,372 | ) |
* | |
** | All share amounts have been retroactively adjusted to reflect a 1-for-10
reverse share split (Note 1) |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ORGENESIS
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S.
Dollars in thousands)
(Unaudited)
| |
September
30, 2024 | | |
September
30, 2023 | |
| |
Nine
Months Ended | |
| |
September
30, 2024 | | |
September
30, 2023 | |
| |
| | |
| |
CASH FLOWS FROM OPERATING
ACTIVITIES: | |
| | | |
| | |
| |
| | | |
| | |
Net loss | |
$ | (28,637 | ) | |
$ | (58,295 | ) |
Adjustments required to reconcile net loss
to net cash used in operating activities: | |
| | | |
| | |
Stock-based compensation | |
| 2,555 | | |
| 387 | |
Convertible loans induced conversion expenses | |
| 4,304 | | |
| - | |
Capital loss, net | |
| 134 | | |
| - | |
Loss from deconsolidation of OBI and Octomera | |
| 66 | | |
| 5,343 | |
Share in income of associated companies, net | |
| - | | |
| 552 | |
Depreciation and amortization expenses | |
| 1,625 | | |
| 1,366 | |
Credit loss on convertible loan receivable | |
| - | | |
| 2,688 | |
Credit loss related to OBI | |
| 2,049 | | |
| - | |
Impairment expenses | |
| 692 | | |
| - | |
Effect of exchange differences on inter-company
balances | |
| 1,672 | | |
| 106 | |
Net changes in operating leases | |
| 41 | | |
| (82 | ) |
Change in Contingent consideration | |
| 263 | | |
| - | |
Interest expenses accrued on loans and convertible
loans | |
| 1,366 | | |
| 880 | |
Loss from extinguishment in connection with
convertible loan restructuring | |
| 141 | | |
| 283 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| 9 | | |
| 30,079 | |
Prepaid expenses and other
accounts receivable | |
| 1,341 | | |
| (1,598 | ) |
Inventory | |
| 34 | | |
| (389 | ) |
Other assets | |
| (4 | ) | |
| 10 | |
Change in related parties,
net | |
| 2 | | |
| - | |
Accounts payable | |
| (1,951 | ) | |
| 3,925 | |
Accrued expenses and other
payables | |
| (846 | ) | |
| 266 | |
Employee and related payables | |
| 168 | | |
| 135 | |
Deferred
taxes, net | |
| (2 | ) | |
| 9 | |
| |
| | | |
| | |
Net cash used in operating activities | |
$ | (14,978 | ) | |
$ | (14,335 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING
ACTIVITIES: | |
| | | |
| | |
Purchase of property, plant and equipment | |
| (263 | ) | |
| (2,096 | ) |
Investment in Octomera | |
| - | | |
| (543 | ) |
Cash acquired from acquisition of Octomera | |
| 139 | | |
| - | |
Impact to cash resulting from deconsolidation
of OBI | |
| (5 | ) | |
| - | |
Impact to cash resulting from deconsolidation
of Octomera | |
| - | | |
| (973 | ) |
| |
| | | |
| | |
Investment in long-term
deposits | |
| 202 | | |
| (33 | ) |
| |
| | | |
| | |
Net cash used in investing
activities | |
$ | 73 | | |
$ | (3,645 | ) |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING
ACTIVITIES: | |
| | | |
| | |
Proceeds from issuance of shares and warrants | |
| 2,556 | | |
| 4,341 | |
Proceeds from issuance of convertible loans | |
| 75 | | |
| 5,660 | |
Proceeds from transaction with redeemable non-controlling
interest that do not acquire control of a subsidiary | |
| - | | |
| 5,000 | |
Repayment of convertible loans and convertible
bonds | |
| - | | |
| (3,000 | ) |
Repayment of short and long-term debt | |
| (251 | ) | |
| (33 | ) |
Proceeds from issuance of loans payable | |
| 4,670 | | |
| 425 | |
Grant received in respect of third party | |
| 790 | | |
| - | |
Receipt from Germfree
(see note 11a) | |
| 6,720 | | |
| - | |
| |
| | | |
| | |
Net cash provided by financing
activities | |
$ | 14,560 | | |
$ | 12,393 | |
| |
| | | |
| | |
NET CHANGE IN CASH, CASH
EQUIVALENTS AND RESTRICTED CASH | |
$ | (345 | ) | |
$ | (5,587 | ) |
EFFECT OF EXCHANGE RATE
CHANGES ON CASH, CASH EQUIVALENTS AND RESTRICTED CASH | |
| (12 | ) | |
| 7 | |
CASH, CASH EQUIVALENTS AND
RESTRICTED CASH AT BEGINNING OF PERIOD | |
| 1,479 | | |
| 6,369 | |
CASH
AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD | |
$ | 1,122 | | |
$ | 789 | |
| |
| | | |
| | |
SUPPLEMENTAL NON-CASH FINANCING
AND INVESTING ACTIVITIES | |
| | | |
| | |
| |
| | | |
| | |
Exchange of convertible loans for equity | |
| 16,007 | | |
| - | |
Right-of-use assets obtained in exchange for
new operation lease liabilities | |
$ | 405 | | |
$ | 752 | |
Increase in accounts payable related to purchase
of property, plant and equipment | |
$ | - | | |
$ | 14 | |
| |
| | | |
| | |
Extinguishment in connection with convertible
loan restructuring | |
$ | - | | |
$ | 287 | |
| |
| | | |
| | |
CASH PAID DURING THE PERIOD
FOR: | |
| | | |
| | |
| |
| | | |
| | |
Interest | |
$ | 4 | | |
$ | 785 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
ORGENESIS
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
the Nine Months Ended September 30, 2024 and 2023
(U.S.
Dollars in thousands, except share and loss per share amounts)
(Unaudited)
NOTE
1 – DESCRIPTION OF BUSINESS
a.
General
Orgenesis
Inc. (the “Company”) is a global biotech company working to unlock the potential of Cell and Gene Therapies (“CGTs”)
in an affordable and accessible format. CGTs can be centered on autologous (using the patient’s own cells) or allogenic (using
master banked donor cells) and are part of a class of medicines referred to as advanced therapy medicinal products (“ATMPs”).
The Company is mostly focused on the development of autologous therapies that can be manufactured under processes and systems that are
developed for each therapy using a closed and automated approach that is validated for compliant production near the patient for treatment
of the patient at the point of care (“POCare”).
As
of the date of this report, the Company operates two segments:
| ● | The
“Octomera” segment which includes the Company’s POCare Services that are
performed in decentralized hubs which provide harmonized and standardized services to customers
(“POCare Centers”). The Company’s subsidiary, Octomera LLC, holds all of
the Octomera segment activities. |
| | |
| ● | The
“Therapies” segment which includes therapy related activities. |
On
January 29, 2024, the Company and Metalmark Capital Partners (“Metalmark” or “MM”) entered into a Unit Purchase
Agreement (the “MM UPA”), pursuant to which the Company acquired all of the preferred units of Octomera LLC (“Octomera”)
previously owned by MM (the “MM Acquisition”), and effective that date, reconsolidated Octomera into its accounts. The Company
currently owns 100% of the equity interests of Octomera. The Company had previously, from June 30, 2023 (“date of deconsolidation”),
deconsolidated Octomera from its consolidated financial statements and had recorded its equity interest in Octomera as an equity method
investment.
These
consolidated financial statements include the accounts of Orgenesis Inc. and its subsidiaries.
On
September 20, 2024, the Company implemented a 1-for-10
reverse stock split (the “Reverse Split”) of its authorized and outstanding shares of Common Stock. All share and per share
amounts in these financial statements have been retroactively adjusted to reflect the reverse split as if it had been effected prior
to the earliest financial statement period included herein. Following the Reverse Split, the number
of authorized shares of common stock that the Company is authorized to issue from time to time is 14,583,333 shares.
The
Company’s common stock, par value $0.0001 per share (the “Common Stock”), is traded on the OTCQX under the symbol “ORGS.”
On September 27, 2023, the Company received a notice from the Listing Qualifications Staff (“Staff”) of The Nasdaq Stock
Market LLC (“Nasdaq”) stating that the bid price of the Common Stock had closed at less than $1.00 per share over the previous
30 consecutive business days, and, as a result, did not comply with Listing Rule 5550(a)(2) (the “Bid Price Rule”). On April
17, 2024, the Company received a notice (the “Notice”) from the Staff in which it determined that in accordance with Listing
Rule 5810(c)(2)(A), the Staff stated that it could not accept a plan to regain compliance and the Staff stated that the Company’s
securities would be delisted from The Nasdaq Capital Market unless the Company timely requested a hearing before a Nasdaq Hearings Panel
(the “Panel”) to address the deficiencies and present a plan to regain compliance. As permitted by the Notice, the Company
timely requested a hearing before the Panel, which request stayed any further delisting action by the Staff pending the ultimate outcome
of the hearing and the expiration of any extension that may be granted by the Panel. On June 6, 2024, the Company met with the Panel
regarding the Company’s potential delisting from The Nasdaq Stock Market as a result of its violation of the Bid Price Rule and
non-compliance with the equity requirement in Listing Rule 5550(b)(1) (the “Equity Rule”) or any of the alternative requirements
in Listing Rule 5550(b). On June 8, 2024, the Company received the Panel’s decision which granted the Company until October 14,
2024 to regain compliance with the Bid Price and Equity Rules. On October 17, 2024, Nasdaq notified the Company that the Panel had determined
to delist the Company’s Common Stock and that trading of the Company’s Common Stock will be suspended at the open of trading
on October 21, 2024. In connection with the Nasdaq delisting notice, Nasdaq will complete the delisting by filing a Form 25 Notification
of Delisting with the U.S. Securities and Exchange Commission (the “SEC”) after applicable appeal periods have lapsed. The
Company’s Common Stock began trading under “ORGS” on the OTCQX with the open of the markets on October 21, 2024.
As
used in this report and unless otherwise indicated, the term “Company” refers to Orgenesis Inc. and its Subsidiaries. Unless
otherwise specified, all amounts are expressed in United States Dollars.
b.
Liquidity
Through
September 30, 2024, the Company had an accumulated deficit of $204,411 and for the nine months ended September 30, 2024 incurred negative
operating cashflows of $14,978. The Company’s activities have been funded by generating revenue, through offerings of its securities,
and through proceeds from loans. There is no assurance that the Company’s business will generate sustainable positive cash flows
to fund its activities.
The
Company will need to use mitigating actions such as seeking additional financing, refinancing, or amending the terms of existing loans,
or postponing expenses that are not based on firm commitments. In order to fund its operations until such time that the Company can generate
sustainable positive cash flows, the Company will need to raise additional funds. For the nine months ended September 30, 2024 and as
of the date of this report, the Company has assessed its financial condition and concluded that based on current and projected cash resources
and commitments, as well as other factors mentioned above, there is substantial doubt about its ability to continue as a going concern.
The Company is planning to raise additional capital to continue its operations and to repay its outstanding loans when they become due,
as well as to explore additional avenues to increase revenues and reduce or delay expenditures. In May 2024, the Company entered into
debt exchange agreements with three convertible debt holders pursuant to which a total of $16,007 of outstanding principal and accrued
interest were exchanged for the right to receive an aggregate of 1,577,694 shares of Common Stock. The Company may also exchange some
of its other outstanding loans and accounts payable for securities of the Company. There can be no assurance that the Company will be
able to raise additional capital on acceptable terms, or at all, or be able to exchange its outstanding loans and accounts payable for
securities of the Company.
The
Company’s Common Stock was delisted from the Nasdaq Capital Market and now trades on the OTCQX. Such delisting and trading on the
OTCQX may make it more difficult to raise additional capital.
The
estimation and execution uncertainty regarding the Company’s future cash flows and management’s judgments and assumptions
in estimating these cash flows is a significant estimate. Those assumptions include reasonableness of the forecasted revenue, operating
expenses, and uses and sources of cash.
NOTE
2 - BASIS OF PRESENTATION
a.
Basis of presentation
The
accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial
statements. In the opinion of management, the financial statements reflect all normal and recurring adjustments necessary to fairly state
the financial position and results of operations of the Company. The information included in this Quarterly Report on Form 10-Q should
be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report
on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (“SEC”) on April
15, 2024. The year-end balance sheet data was derived from the audited consolidated financial statements as of December 31, 2023, but
not all disclosures required by generally accepted accounting principles in the United States (“U.S. GAAP”) are included
in this Quarterly Report on Form 10-Q.
b.
Significant accounting policies
The
accounting policies adopted are consistent with those of the previous financial year except as described below:
Use
of Estimates in the Preparation of Financial Statements
The
preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires us to make estimates, judgments
and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of
contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies. The Company
bases its estimates on historical experience and on various other assumptions that it believes are reasonable, the results of which form
the basis for making judgments about the carrying values of assets, liabilities and equity, the amount of revenues and expenses, determination
of loss on deconsolidation, valuation of investments, purchase price allocations, goodwill impairment, and assessment of credit losses
and purchase price allocation including contingent consideration. Actual results could differ from those estimates.
Recently
issued accounting pronouncements, not yet adopted
Improvements
to Public Business Entity’s Expenses Disclosures
In
November 2024, the FASB issued ASU No. 2024-03 Income Statement—Reporting Comprehensive Income—Expense Disaggregation
Disclosures (Subtopic 220-40). The ASU improves the disclosures about a public business entity’s expenses and provides more detailed
information about the types of expenses in commonly presented expense captions. The amendments require that at each interim and annual
reporting period an entity will, inter alia, disclose amounts of purchases of inventory, employee compensation, depreciation and amortization
included in each relevant expense caption (such as cost of sales, SG&A and research and development). The ASU is effective for fiscal
years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption
is permitted. The Company is currently evaluating this ASU to determine its impact on the Company’s disclosures.
Improvements
to Reportable Segments Disclosures
In
November 2023, the FASB issued ASU 2023-07 “Segment Reporting–Improvements to Reportable Segments Disclosures (Topic 280)”
to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The
amendments in this ASU (1) require that a public entity disclose, on an annual and interim basis, significant segment expenses that are
regularly provided to the chief operating decision maker (“CODM”) and included within each reported measure of segment profit
or loss; (2) require that a public entity disclose, on an annual and interim basis, an amount for other segment items by reportable segment
and a description of its composition; (3) require that a public entity provide all annual disclosures about a reportable segment’s
profit or loss and assets currently required by Topic 280 in interim periods; (4) clarify that if the CODM uses more than one measure
of a segment’s profit or loss in assessing segment performance and deciding how to allocate resources, a public entity may report
one or more of those additional measures; and (5) require that a public entity disclose the title and position of the CODM and an explanation
of how the CODM uses the reported measure or measures of segment profit or loss in assessing segment performance and deciding how to
allocate resources. The amendments in this ASU are effective for fiscal years beginning after December 15, 2023, and interim periods
within fiscal years beginning after December 15, 2024, and should be applied retrospectively to all periods presented. Early adoption
is permitted. The Company is currently evaluating the impact of the adoption of these amendments on its consolidated financial statements.
Improvements
to Income Tax Disclosures
In
December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740)–Improvements to Income Tax Disclosures” to enhance
the transparency and decision usefulness of income tax disclosures, primarily related to the rate reconciliation and income taxes paid
information. The amendments in this ASU require that public entities, on an annual basis, disclose specific categories in the rate reconciliation
and provide additional information for reconciling items that meet a quantitative threshold. This ASU also requires that all entities
disclose, on an annual basis, (1) the amount of income taxes paid disaggregated by federal, state, and foreign taxes, (2) the amount
of income taxes paid disaggregated by individual jurisdictions in which income taxes paid is equal to or greater than five percent of
total income taxes paid, (3) income or loss from continuing operations before income tax expense or benefit disaggregated between domestic
and foreign, and (4) income tax expense or benefit from continuing operations disaggregated by federal, state, and foreign. The amendments
in this ASU are effective for annual periods beginning after December 15, 2024, and should be applied on a prospective basis with the
option to apply retrospectively. Early adoption is permitted for annual financial statements that have not yet been issued or made available
for issuance. The Company is currently evaluating the impact of the adoption of these amendments on its consolidated financial statements.
NOTE
3 – SEGMENT INFORMATION
Segment
data for the nine months ended September 30, 2024 is as follows:
SCHEDULE OF SEGMENT REPORTING
| |
Octomera | | |
Therapies | | |
Eliminations | | |
Consolidated | |
| |
(in
thousands) | |
Revenues | |
$ | 322 | | |
$ | 435 | | |
$ | (23 | ) | |
$ | 734 | |
Cost of revenues* | |
| (1,292 | ) | |
| (521 | ) | |
| 710 | | |
| (1,103 | ) |
Gross profit | |
| (970 | ) | |
| (86 | ) | |
| 687 | | |
| (369 | ) |
Cost of development services and research
and development expenses* | |
| (4,542 | ) | |
| (4,079 | ) | |
| 699 | | |
| (7,922 | ) |
Operating expenses* | |
| (1,226 | ) | |
| (9,012 | ) | |
| (728 | ) | |
| (10,966 | ) |
Impairment expenses ** | |
| - | | |
| (692 | ) | |
| - | | |
| (692 | ) |
Loss from deconsolidation | |
| - | | |
| - | | |
| (66 | ) | |
| (66 | ) |
Other income | |
| (126 | ) | |
| 12 | | |
| - | | |
| (114 | ) |
Depreciation and amortization | |
| (1,171 | ) | |
| (581 | ) | |
| 127 | | |
| (1,625 | ) |
Loss from extinguishment in connection with
convertible loan | |
| - | | |
| (141 | ) | |
| - | | |
| (141 | ) |
Credit losses on convertible loan receivable | |
| | | |
| | | |
| | | |
| | |
Financial income (expenses), net | |
| (756 | ) | |
| (1,752 | ) | |
| 123 | | |
| (2,385 | ) |
Convertible loans induced
conversion expenses | |
| - | | |
| (4,304 | ) | |
| - | | |
| (4,304 | ) |
Share in net income of associated companies | |
| | | |
| | | |
| | | |
| | |
* | Excluding Depreciation,
amortization expenses |
** | Relates to impairment expenses on certain property, plant and equipment. |
Segment
data for the nine months ended September 30, 2023 is as follows:
| |
Octomera | | |
Therapies | | |
Eliminations | | |
Consolidated | |
| |
(in
thousands) | |
Revenues | |
$ | 44 | | |
$ | 350 | | |
$ | (29 | ) | |
$ | 365 | |
Cost of revenues* | |
| (6,959 | ) | |
| (531 | ) | |
| 1,874 | | |
| (5,616 | ) |
Gross profit | |
| (6,915 | ) | |
| (181 | ) | |
| 1,845 | | |
| (5,251 | ) |
Cost of development services and research
and development expenses* | |
| (6,828 | ) | |
| (2,830 | ) | |
| 2,327 | | |
| (7,331 | ) |
Operating expenses* | |
| (31,921 | ) | |
| (4,962 | ) | |
| 3,930 | | |
| (32,953 | ) |
Loss from deconsolidation of Octomera | |
| - | | |
| - | | |
| (5,343 | ) | |
| (5,343 | ) |
Other income, net | |
| 2 | | |
| 2 | | |
| | | |
| 4 | |
Depreciation and amortization | |
| (1,294 | ) | |
| (589 | ) | |
| 517 | | |
| (1,366 | ) |
Loss from extinguishment in connection with
convertible loan | |
| - | | |
| (283 | ) | |
| - | | |
| (283 | ) |
Credit losses on convertible loan receivable | |
| - | | |
| (2,688 | ) | |
| - | | |
| (2,688 | ) |
Financial (expenses) income, net | |
| (587 | ) | |
| (1,425 | ) | |
| 94 | | |
| (1,918 | ) |
Share in net income of
associated companies | |
| - | | |
| (10 | ) | |
| (542 | ) | |
| (552 | ) |
* | Excluding Depreciation,
amortization expenses |
Segment
data for the three months ended September 30, 2024 is as follows:
| |
Octomera | | |
Therapies | | |
Eliminations | | |
Consolidated | |
| |
(in thousands) | |
Revenues | |
$ | 272 | | |
$ | 75 | | |
$ | - | | |
$ | 347 | |
Cost of revenues* | |
| (245 | ) | |
| (192 | ) | |
| - | | |
| (437 | ) |
Gross profit | |
| 27 | | |
| (117 | ) | |
| - | | |
| (90 | ) |
Cost of development services and research and development expenses* | |
| (1,291 | ) | |
| (3,048 | ) | |
| 2 | | |
| (4,337 | ) |
Operating expenses* | |
| (680 | ) | |
| (1,975 | ) | |
| (82 | ) | |
| (2,737 | ) |
Impairment expenses** | |
| - | | |
| (692 | ) | |
| - | | |
| (692 | ) |
Other income | |
| (126 | ) | |
| 4 | | |
| - | | |
| (122 | ) |
Depreciation and amortization | |
| (301 | ) | |
| (194 | ) | |
| (43 | ) | |
| (538 | ) |
Financial expenses, net | |
| (202 | ) | |
| (515 | ) | |
| (1 | ) | |
| (718 | ) |
* | Excluding Depreciation,
amortization expenses |
** | Relates to impairment expenses on certain property, plant and equipment. |
Segment
data for the three months ended September 30, 2023 is as follows:
| |
Octomera | | |
Therapies | | |
Eliminations | | |
Consolidated | |
| |
(in
thousands) | |
Revenues | |
$ | 29 | | |
$ | 110 | | |
$ | (29 | ) | |
$ | 110 | |
Cost of revenues* | |
| (1,875 | ) | |
| (133 | ) | |
| 1,874 | | |
| (134 | ) |
Gross profit | |
| (1,846 | ) | |
| (23 | ) | |
| 1,845 | | |
| (24 | ) |
Cost of development services and research
and development expenses* | |
| (2,327 | ) | |
| (779 | ) | |
| 2,327 | | |
| (779 | ) |
Operating expenses* | |
| (3,931 | ) | |
| (1,240 | ) | |
| 3,930 | | |
| (1,241 | ) |
Other income | |
| - | | |
| 2 | | |
| - | | |
| 2 | |
Depreciation and amortization | |
| (515 | ) | |
| (193 | ) | |
| 517 | | |
| (191 | ) |
Financial (expenses) income, net | |
| (92 | ) | |
| (546 | ) | |
| 93 | | |
| (545 | ) |
Share in net income of
associated companies | |
| - | | |
| (11 | ) | |
| (542 | ) | |
| (553 | ) |
NOTE
4 – RECONSOLIDATION OF OCTOMERA LLC
Pursuant
to the MM UPA signed on January 29, 2024, the Company and MM agreed to the following:
| ● | Royalty
Payments: If Octomera and its subsidiaries generate Net Revenue during the three-year period
2025-2027, then the Company will pay 5% of Net Revenues to MM pursuant to the MM UPA. |
| | |
| ● | Milestone
Payments: If the Company sells Octomera within ten years from the date of the Closing at
a price that is more than $40 million excluding consideration for certain Excluded Assets
as per the UPA, the Company shall pay MM 5% of the net proceeds. |
| 2. | MM’s
designated members of the Board of Managers of Octomera resigned and the Company amended
the Second Amended and Restated Limited Liability Company Agreement of Octomera (the “Octomera
LLC Agreement”) to be a single member agreement reflecting the transactions consummated
under the UPA, such that MM no longer (i) is a member of Octomera or a party to the Octomera
LLC Agreement, or (ii) has a right to appoint members of the board of managers of Octomera. |
| | |
| 3. | 10
secured promissory notes between Orgenesis Maryland LLC and MM, reflecting an aggregate outstanding
principal amount of $2,600 (the “Notes”), were amended to, among other things,
extend the maturity thereof to January 29, 2034 and to terminate the security interest granted
by Orgenesis Maryland LLC in favor of MM that secured the obligations under the Notes. |
Fair
Value of Consideration Transferred
Accounting
guidance provides that the allocation of the purchase price may be adjusted for up to one year from the date of the acquisition to the
extent that additional information is obtained about the facts and circumstances that existed as of the acquisition date. The primary
area of the purchase price allocation that is not yet finalized is related to intangible assets, property, plant and equipment, and certain
other assets and tax matters and the related impact on goodwill.
In
evaluating the fair value of the Octomera Equity Investment under the income approach, the Company used a discounted cash flow model
of the business, adjusted to the Company’s share in the investment. Key assumptions used to determine the estimated fair value
included: (a) internal cash flows forecasts for 5 years following the assessment date, including expected revenue growth, costs to produce,
operating profit margins and estimated capital needs; (b) an estimated terminal value using a terminal year long-term future growth determined
based on the growth prospects of the reporting units; and (c) a discount rate which reflects the weighted average cost of capital adjusted
for the relevant risk associated with the Company’s reporting unit operations and the uncertainty inherent in the Company’s
internally developed forecasts. The allocation of the purchase price to the net assets acquired and liabilities assumed resulted in the
recognition of other intangible assets, net, which comprised of technology. The useful life of the technology for amortization purposes
was determined by considering the period of expected cash flows generated by the assets used to measure the fair value of the intangible
assets, adjusted as appropriate for the entity-specific factors including legal, regulatory, contractual, competitive, economic, or other
factors that may limit the useful life of intangible assets.
The
following table summarizes the allocation of purchase price to the fair values of the assets acquired and liabilities assumed as of the
Transaction date:
SCHEDULE OF PURCHASE PRICE TO THE FAIR VALUES OF THE ASSETS ACQUIRED AND LIABILITIES ASSUMED
| |
(in
thousands) | |
Total Contingent
consideration to MM for royalty and milestone payments | |
$ | 4,643 | |
| |
| | |
Total assets acquired: | |
| | |
Cash and cash equivalents | |
$ | 139 | |
Property, plants and equipment,
net | |
| 17,852 | |
Other
Assets | |
| 3,478 | |
Total
assets | |
$ | 21,469 | |
| |
| | |
Total liabilities assumed: | |
| | |
Total current liabilities | |
$ | (12,518 | ) |
Total
long-term liabilities | |
| (5,628 | ) |
Total
liabilities | |
$ | (18,146 | ) |
| |
| | |
Know
how Technology | |
| 1,728 | |
| |
| | |
Total
Net Assets | |
$ | 5,051 | |
Fair-Value
of Non-controlling interests | |
| (408 | ) |
Total
liability to MM | |
$ | 4,643 | |
The
allocation of the purchase price to the net assets acquired and liabilities assumed resulted in the recognition of an intangible asset
know-how of $1,728 and a liability to MM in the amount of $4,643. The know-how has a useful life of 10 years. The useful life of the
intangible asset for amortization purposes was determined considering the period of expected cash flows generated by the assets used
to measure the fair value of the intangible asset adjusted as appropriate for the entity-specific factors, including legal, regulatory,
contractual, competitive, economic or other factors that may limit the useful life of intangible assets.
Key
inputs for the fair values valuation are summarized below.
SCHEDULE OF
KEY INPUTS FOR THE FAIR VALUES VALUATION
Key Valuation
Inputs | |
Jan
29, 2024 | |
Discount rate | |
| 40 | % |
Risk-free interest rate | |
| 4.4 | % |
Average 5 years revenue growth | |
| 50 | % |
Measurement input | |
| 50 | % |
The
Company incurred transaction costs of approximately $50 and $0 during the nine and three months ended September 30, 2024 respectively,
which were included in general and administrative expenses in the condensed consolidated statements of operations.
The
revenues and net loss of Octomera from January 1, 2024 until the reconsolidation date were $23 and $1,244 respectively.
Fair
value assumptions used in accounting for contingent consideration
On
January 29, 2024, in connection with the PPA study of Octomera LLC, the Company recognized a contingent consideration to pay MM based
on two components:
1. Royalties based on revenues in 2025, 2026 and 2027, and;
2. An earnout amount, which is dependent on a future triggering event being either an IPO or exit.
The
estimated fair value of the contingent consideration is based on management’s assessment of whether, and at what level, the financial
metrics will be achieved, and the present value factors associated with the timing of the payments. This fair value measurement is based
on significant unobservable inputs in the market and thus represents a Level 3 fair value measurement and used the Monte Carlo pricing
model to calculate the fair value, which was $4,643
as of January 29, 2024. As of September 30, 2024,
the fair value was $4,906.
Changes in the fair value of contingent consideration are recorded in operating expenses. The total revaluation expense for the period
ended September 30, 2024 was $ 263.
Key
inputs for the simulation are summarized below.
SCHEDULE
OF KEY INPUTS
Key Valuation
Inputs | |
Jan
29, 2024 | | |
September
30, 2024 | |
Standard Deviation | |
| 13.5 | % | |
| 13.6 | % |
Risk-free interest rate | |
| 4.4 | % | |
| 4.2 | % |
Possible trigger event examination | |
| Year
10 | | |
| Year
9.5 | |
Average 5 years revenue growth | |
| 50 | % | |
| 50 | % |
Trigger events | |
| 30 | % | |
| 30 | % |
EV/EBIT Multiple | |
| 11.1 | | |
| 11.1 | |
* | Based on a Monte
Carlo simulation analysis of 30,000 iterations |
Deconsolidation
of Orgenesis Biotech Israel Limited (“OBI”)
On
February 14, 2024, following a claim for payment by employees of OBI, a fully owned subsidiary of Octomera of past salaries due, the
district court in Haifa, Israel appointed a trustee to run the affairs of OBI. As a result of this appointment, effective February 14,
2024, the Company no longer controls OBI and has ceased to consolidate the results of OBI into its consolidated results. The Company
recognized a loss as a result of the deconsolidation of $66. The Company does not currently believe that rehabilitation is possible and
purchased certain OBI equipment.
The
Company recorded $2,699 being what it owes to OBI under Accounts payable related Parties on the balance sheet of September 30, 2024.
The
following table summarizes the deconsolidated assets and liabilities as of February 14, 2024:
SCHEDULE
OF DECONSOLIDATE ASSETS AND LIABILITIES
| |
| |
Total assets acquired: | |
| | |
Cash and cash
equivalents | |
$ | 4 | |
Property, plants and equipment,
net | |
| 2,884 | |
Other
Assets | |
| 1,422 | |
Total
assets | |
$ | 4,310 | |
| |
| | |
Total
liabilities assumed: | |
$ | 4,244 | |
Total
Net Assets deconsolidated | |
$ | 66 | |
Loss
from deconsolidation of OBI | |
$ | 66 | |
NOTE
5 – EQUITY
Private
Placement Offering
On
March 3, 2024, the Company entered into a Securities Purchase Agreement with certain accredited investors, pursuant to which the Company
agreed to issue and sell, in a private placement, 227,272 shares of Common Stock at a purchase price of $10.3 per share, Warrants to
purchase up to 227,272 shares of Common Stock at an exercise price of $15.0 per share, and further Warrants to purchase up to 227,272
shares of Common Stock at an exercise price of $20.0 per share, all such Warrants exercisable immediately and expiring five years from
their date of issuance. The Company received gross proceeds of approximately $2.3 million before deducting related offering expenses.
The Offering closed on March 5, 2024.
On
May 10, 2024, the Company entered into a Securities Purchase Agreement with certain accredited investors, pursuant to which the Company
agreed to issue and sell, in a private placement, 15,000 shares of the Company’s Common Stock at a purchase price of $10.3 per
share, Warrants to purchase up to 15,000 shares of Common Stock at an exercise price of $15.0 per share, and further Warrants to purchase
up to 15,000 shares of Common Stock at an exercise price of $20.0 per share, all such Warrants exercisable immediately and expiring five
years from their date of issuance. The Company received gross proceeds of approximately $154 before deducting related offering expenses.
The Offering closed on May 10, 2024.
NOTE
6 – CONVERTIBLE LOANS
The
table below summarizes the Company’s outstanding convertible loans as of September 30, 2024.
SCHEDULE OF LONG TERM CONVERTIBLE NOTES
Principal Amount | | |
Issuance Date | | |
Current Interest Rate | | |
Current Maturity | | |
Current Conversion Price of loan into equity | |
at Issuance | | |
(Year) | | |
% | | |
(Year) | | |
$ | |
$ | 100 | | |
| 2019 | | |
| 8 | % | |
| 2024 | | |
| 10.3 | |
| 100 | | |
| 2020 | | |
| 8 | % | |
| 2024 | | |
| 10.3 | |
| 1,150 | | |
| 2022 | | |
| 6 | % | |
| *2023 | | |
| 45.0 | |
| 5,000 | | |
| 2023 | | |
| 8 | % | |
| 2026 | | |
| 24.6 | |
$ | 6,350 | | |
| | | |
| | | |
| | | |
| | |
The
table below summarizes the Company’s outstanding convertible loans as of December 31, 2023.
Principal | | |
Issuance Date | | |
Current Interest Rate | | |
Current Maturity | | |
Current Conversion Price of loan into equity | | |
| |
Amount | | |
(Year) | | |
% | | |
(Year) | | |
$ | | |
Note | |
Convertible Loans Outstanding as of December 31, 2023 | | |
| |
$ | 750 | | |
| 2018 | | |
| 10 | % | |
| 2026 | | |
| 25.0 | | |
| | |
| 1,500 | | |
| 2019 | | |
| 10 | % | |
| 2026 | | |
| 25.0 | | |
| | |
| 100 | | |
| 2019 | | |
| 8 | % | |
| 2024 | | |
| 70.0 | | |
| | |
| 5,000 | | |
| 2019 | | |
| 10 | % | |
| 2026 | | |
| 25.0 | | |
| | |
| 100 | | |
| 2020 | | |
| 8 | % | |
| 2024 | | |
| 70.0 | | |
| | |
| 5,000 | | |
| 2022 | | |
| 10 | % | |
| 2026 | | |
| 25.0 | | |
| | |
| 1,150 | | |
| 2022 | | |
| 6 | % | |
| **2023 | | |
| 45.0 | | |
| | |
| 5,000 | | |
| 2023 | | |
| 8 | % | |
| 2026 | | |
| 24.6 | | |
| | |
| 735 | | |
| 2023 | | |
| 8 | % | |
| 2024 | | |
| 08.5 | | |
| | |
$ | 19,335 | | |
| | | |
| | | |
| | | |
| | | |
| | |
Debt
Exchange Agreements
On
May 21, 2024, the Company entered into debt exchange agreements with three convertible debt holders pursuant to which a total of $16,007
of outstanding principal and accrued interest was exchanged for the right to receive an aggregate of 1,577,695 shares of Common Stock
of the Company. A total of 1,182,919 shares of Common Stock have been issued pursuant to the debt exchange agreements as of September
30, 2024. The Company reduced the exchange price from $25.0 to $10.3 per share for a total of $14,784 of outstanding principal. As a
result, the Company recorded an induced conversion expense equal to the fair value of the incremental consideration, amounting to $4,304.
Additional
notes related to changes in convertible loans terms that occurred in 2024
In
January 2024, the Company and lender agreed to extend the maturity date of the loan amount to December 31, 2026. In consideration for
such extension, the Company issued to the lender warrants to purchase 84,000 shares of Common Stock at an exercise price of $8.5 per
share. Based on its analysis, the Company concluded that this change in terms should be accounted for as an extinguishment. The loan
amount was included in the debt exchange agreement.
NOTE
7 –LOANS
The
table below summarizes the Company’s outstanding long-term loans as of September 30, 2024 and December 31, 2023, respectively:
SCHEDULE OF LONG TERM LOANS
Principal Amount | | |
Interest Rate | | |
Year of Maturity | | |
September 30, 2024 | | |
December31, 2023 | |
(in thousands) | | |
% | | |
| | |
(in thousands) | |
$ | 2,600 | | |
| 10 | | |
| 2034 | | |
$ | 2,828 | | |
$ | - | |
See
note 4.
The
table below summarizes the Company’s outstanding short-term loans as of September 30, 2024 and December 31, 2023, respectively:
SCHEDULE OF SHORT TERM LOANS
Currency | |
Interest Rate | | |
September 30, 2024 | | |
December 31, 2023 | |
| |
% | | |
(in thousands) | |
USD | |
| 8 | | |
$ | 287 | | |
$ | 258 | |
USD | |
| 10 | | |
| 4,603 | | |
| 61 | |
USD | |
| (*)8 | | |
| - | | |
| (**)331 | |
Euro | |
| 8 | | |
| 15 | | |
| - | |
| |
| | | |
$ | 4,905 | | |
$ | 650 | |
During
October 2024, the Company entered into short term loan agreements with certain parties for a total of $790. The loans bear 10% annual
interest, and the loan holders were issued warrants to purchase a total of 767,089 shares of Common Stock of the Company at a price of
$1.03 per share. In addition, during October 2024, the Company agreed with certain short term loan holders to extend the maturity date
of loans in the amount of $2,300. The Company reduced the warrant exercise price for 526,187 warrants held by such loan holders to $1.03.
The
table below summarizes the Company’s warrants granted to loan holders for the period ended September 30, 2024.
SCHEDULE
OF WARRANTS GRANTED
Date of issuance | |
Reason for issuance | |
Number of warrants | | |
Weighted Average Exercise price | | |
Warrant vesting (subject to continued service provided to Company) | |
Expiration date |
April 07, 2024 | |
Loan Agreement | |
| 15,625 | | |
$ | 8 | | |
Immediate | |
October 06, 2024 |
April 05, 2024 | |
Loan Agreement | |
| 21,875 | | |
$ | 8 | | |
Immediate | |
October 04, 2024 |
August 21, 2024 | |
Loan Agreement | |
| 24,272 | | |
$ | 10.3 | | |
Immediate | |
August 20, 2029 |
August 21, 2024 | |
Loan Agreement | |
| 97,088 | | |
$ | 10.3 | | |
Immediate | |
August 20, 2029 |
September 06, 2024 | |
Loan Agreement | |
| 24,272 | | |
$ | 10.3 | | |
Immediate | |
September 05, 2025 |
September 10, 2024 | |
Loan Agreement | |
| 1,942 | | |
$ | 10.3 | | |
Immediate | |
September 09, 2025 |
September 09, 2024 | |
Loan Agreement | |
| 24,272 | | |
$ | 10.3 | | |
Immediate | |
September 08, 2029 |
September 17, 2024 | |
Loan Agreement | |
| 24,272 | | |
$ | 10.3 | | |
Immediate | |
September 16, 2029 |
September 30, 2024 | |
Loan Agreement | |
| 14,563 | | |
$ | 10.3 | | |
Immediate | |
September 29, 2025 |
Total | |
| |
| 248,181 | | |
$ | 10.0 | | |
| |
|
NOTE
8 – STOCK-BASED COMPENSATION
|
a. |
Options
Granted to Employees |
The
table below summarizes the terms of options for the purchase of shares in the Company granted to employees during the period from January
1, 2024 to September 30, 2024:
SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES
| |
No.
of Options Granted | | |
Exercise
Price | | |
Vesting Period | |
Fair Value at Grant (in
thousands) | | |
Expiration Period |
Employees | |
| 126,912 | | |
| $5.0-$10.3 | | |
41,100 quarterly over a period of two years, 20,000 quarterly over a period of four years, 1,250 annually over a period of three years and 64,563 immediate | |
$ | 655 | | |
10 years |
The
fair valuation of these option grants is based on the following assumptions:
SCHEDULE
OF STOCK OPTIONS ACTIVITY
| |
During the Period from January 1, 2024 to September 30, 2024 | |
Value of one common share | |
| $4.9-$10.3 | |
Dividend yield | |
| 0 | % |
Expected stock price volatility | |
| 79%-110 | % |
Risk free interest rate | |
| 3.86%-4.49 | % |
Expected term (years) | |
| 2.50-6.06 | |
|
b. |
Restricted
Stock Units (“RSUs”) Granted to Employees |
Below
is a table summarizing all the RSUs grants to employees during the period from January 1, 2024 to September 30, 2024:
SCHEDULE
OF RESTRICTED STOCK UNITS GRANTED
| |
No.
of Options Granted | | |
Vesting Period | |
Fair Value at Grant (in thousands) | |
Employees | |
| 8,250 | | |
5,000 Immediate and 3,250 quarterly over a period of two years | |
$ | 44 | |
|
c. |
Shares
and warrants issued to advisors. |
Below
is a table summarizing the shares and warrants grants to advisers during the period from January 1, 2024 to September 30, 2024:
SCHEDULE
OF SHARES AND WARRANTS GRANTS TO ADVISORS
Date of issue of share or warrant | |
Reason for issue of share or warrant | |
Consideration | |
Exercise price of warrants | | |
Warrant vesting (subject to continued service provided to Company) | |
Warrant expiry date |
March 7, 2024 | |
Strategic advisor agreement | |
50,000 shares of Common Stock and warrants to purchase 50,000 shares of Common Stock | |
$ | 10.3 | | |
One third on March 7, 2024, one third on June 5, 2024, and one third on September 3, 2024. | |
March 6, 2029 |
April 18, 2024 | |
Strategic advisor agreement | |
Warrants to purchase 50,000 shares of Common Stock | |
$ | 10.3 | | |
One third on April 18, 2024, one third on July 18, 2024, and one third on October 18, 2024. | |
April 17, 2029 |
April 23, 2024 | |
Strategic advisor agreement | |
Warrants to purchase 50,000 shares of Common Stock | |
$ | 10.3 | | |
One third on April 16, 2024, one third on July 16, 2024, and one third on October 16, 2024. | |
April 22, 2029 |
May 22, 2024 | |
Strategic advisor agreement | |
Warrants to purchase 47,500 shares of Common Stock | |
$ | 10.3 | | |
One third on May 21, 2024, one third on August 21, 2024, and one third on November 21, 2024. | |
May 21, 2029 |
July 14, 2024 | |
Strategic advisor agreement | |
Warrants to purchase 20,000 shares of Common Stock | |
$ | 10.3 | | |
One third on July 14, 2024, one third on October 14, 2024, and one third on January 14, 2024. | |
July 13, 2029 |
September 5, 2024 | |
Strategic advisor agreement | |
50,000 shares of Common | |
$ | 10.3 | | |
| |
|
| |
No.
of Warrants Granted | | |
Vesting Period | |
Fair Value at Grant (in thousands) | |
Warrants | |
| 217,500 | | |
Over a period of nine months | |
$ | 646 | |
Shares | |
| 50,000 | | |
N/A | |
$ | 350 | |
The
fair valuation of these shares grants is based on the market value of the share at the date of grant.
The
fair valuation of these warrants grants is based on the following assumptions:
SCHEDULE OF WARRANTS GRANTS
ASSUMPTIONS
| |
During the Period from January 1, 2024 to September 30, 2024 | |
Value of one common share | |
| $5.1-$8.4 | |
Dividend yield | |
| 0 | % |
Expected stock price volatility | |
| 87%-91 | % |
Risk free interest rate | |
| 4.07%-4.68 | % |
Expected term (years) | |
| 5 | |
NOTE
9 – LOSS PER SHARE
The
following table sets forth the calculation of basic and diluted loss per share for the period indicated:
SCHEDULE
OF BASIC AND DILUTED LOSS PER SHARE
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands, except per share data) | |
Basic and diluted: | |
| | | |
| | | |
| | | |
| | |
Net loss attributable to Orgenesis Inc. | |
$ | 9,120 | | |
$ | 3,725 | | |
$ | 27,789 | | |
$ | 48,738 | |
Weighted average number of common shares outstanding | |
| 4,715,229 | | |
| 3,002,259 | | |
| 3,938,419 | | |
| 2,868,078 | |
Net loss per share | |
$ | 1.93 | | |
$ | 0.12 | | |
$ | 7.06 | | |
$ | 1.70 | |
For
the nine months ended September 30, 2024 and September 30, 2023, all outstanding convertible notes, options and warrants have been excluded
from the calculation of the diluted net loss per share since their effect was anti-dilutive.
Diluted
loss per share excludes 1,613,665 shares underlying outstanding options and warrants and 247,895 shares issuable upon conversion of convertible
loans for the nine months ended September 30, 2024, because the effect of their inclusion in the computation would be antidilutive. Diluted
loss per share excludes 1,825,724 shares underlying outstanding options and warrants and 247,895 shares issuable upon conversion of convertible
loans for the three months ended September 30, 2024, because the effect of their inclusion in the computation would be antidilutive.
Diluted
loss per share excludes 768,004 shares underlying outstanding options and warrants and 713,902 shares upon conversion of convertible
loans for the nine months ended September 30, 2023, because the effect of their inclusion in the computation would be antidilutive. Diluted
loss per share excludes 796,348 shares underlying outstanding options and warrants and 721,335 shares issuable conversion of convertible
loans for the three months ended September 30, 2023, because the effect of their inclusion in the computation would be antidilutive.
NOTE
10 – REVENUES
Disaggregation
of Revenue
The
following table disaggregates the Company’s revenues by major revenue streams:
SCHEDULE
OF DISAGGREGATION OF REVENUE
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Revenue stream: | |
| | | |
| | | |
| | | |
| | |
Cell process development services and hospital services | |
$ | 347 | | |
$ | 110 | | |
$ | 734 | | |
$ | 365 | |
Total | |
$ | 347 | | |
$ | 110 | | |
$ | 734 | | |
$ | 365 | |
A
breakdown of the revenues per customer constituted at least 10% of revenues is as follows:
SCHEDULE
OF BREAKDOWN OF REVENUES PER CUSTOMER
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Revenue earned: | |
| | | |
| | | |
| | | |
| | |
Customer A (United States) | |
$ | 265 | | |
$ | - | | |
$ | 265 | | |
$ | 130 | |
Customer B (United States) | |
$ | - | | |
$ | - | | |
$ | 300 | | |
$ | - | |
Revenue earned | |
$ | - | | |
$ | - | | |
$ | 300 | | |
$ | - | |
Contract
Assets and Liabilities
Contract
assets are mainly comprised of trade receivables net of allowance for doubtful debts, which includes amounts billed and currently due
from customers.
The
activity for trade receivables is comprised of:
SCHEDULE
OF ACTIVITY FOR TRADE RECEIVABLES
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Balance as of beginning of period | |
$ | 88 | | |
$ | 36,183 | |
Reconsolidation (deconsolidation) of Octomera | |
| 82 | | |
| (5,985 | ) |
Additions | |
| 458 | | |
| 403 | |
Collections | |
| (981 | ) | |
| (6,090 | ) |
Allowances for credit losses | |
| 512 | | |
| (24,388 | ) |
Exchange rate differences | |
| 2 | | |
| (52 | ) |
Balance as of end of period | |
$ | 161 | | |
$ | 71 | |
The
activity for contract liabilities is comprised of:
SCHEDULE
OF ACTIVITY FOR CONTRACT LIABILITIES
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Balance as of beginning of period | |
$ | 200 | | |
$ | 70 | |
Deconsolidation of Octomera | |
| 110 | | |
| (106 | ) |
Deconsolidation of OBI | |
| (60 | ) | |
| - | |
Deconsolidation | |
| (60 | ) | |
| - | |
Additions | |
| 160 | | |
| 156 | |
Realizations | |
| (279 | ) | |
| - | |
Balance as of end of period | |
$ | 131 | | |
$ | 120 | |
NOTE
11 – OTHER SIGNIFICANT TRANSACTIONS AND AGREEMENTS DURING THE NINE MONTHS ENDED SEPTEMBER 30, 2024
|
a. |
Asset
Purchase and Strategic Collaboration Agreement. |
On
April 5, 2024, the Company entered into an Asset Purchase and Strategic Collaboration Agreement (the “Purchase Agreement”)
with Griffin Fund 3 BIDCO, Inc., (“Germfree”), for the sale by the Company of five Orgenesis Mobile Processing Units and
Labs (“OMPULs”) to Germfree, which will be incorporated into Germfree’s lease fleet and leased back to the Company
or to third-party lessees designated by the Company. Pursuant to the Purchase Agreement, and subject to the terms and conditions set
forth therein, in consideration for the purchase of the OMPULs, the Orgenesis Quality Management Systems Framework (“OQMSF”)
and related intellectual property rights, Germfree is to pay an aggregate purchase price of $8,340 subject to adjustment through a verification
mechanism set forth in the Purchase Agreement. Pursuant to the Purchase Agreement, Germfree has paid the Company $6,720 as of September
30, 2024, which has been recorded under current liabilities.
On November 5, 2024, Germfree
notified the Company of its intention not to lease any OMPULS back to the Company. Germfree confirmed that it has satisfied its obligations
to the Company under the Purchase Agreement, and the Company therefore does not expect to receive any further payments thereunder. The
Company and Germfree plan to resolve any outstanding issues together.
|
b. |
Asset
Purchase Agreement with Broaden. |
On
July 10, 2024, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Broaden Bioscience
and Technology Corp. (“Broaden”) for the purchase by the Company of the following assets (the “Assets”): The
process and algorithms developed by Broaden for processing CAR-T, RACE CAR-T and all oncology products that will enable the Company
to develop and sell treatments to third parties, which include Broaden’s rights, title and interests in and to all
intellectual property, including, but not limited to, patents, patent applications, know-how, materials, licenses, permits and
approvals related thereto. Pursuant to the Purchase Agreement, in consideration for the purchase of the Assets, the Company will pay
Broaden an amount equal to the value of the Assets established with the assistance of a third party valuation firm not to exceed
$11,000
(the “Consideration”), less a debt adjustment relating to $10,767
owed to the Company by Broaden for work performed and invoiced (but fully impaired in the Company’s financial statements)
between August 2022 and May 2023 (the “Debt”), as detailed in the Purchase Agreement. The Consideration that exceeds the
Debt will be payable at the election of the Company in shares of the Company’s common stock at a price of $30.0
per share or 10%
above the market price at such time it is paid, whichever is higher, or a note with amortization in 24 months from the date of the
Purchase Agreement, including prepayment provisions. The Company accounted for the Purchase agreement by recording the difference
between the Consideration and Debt as research and development expenses, and the consideration that exceeds the debt was recorded in other long
term liabilities.
Asset
Purchase Agreement with Theracell.
On
July 12, 2024, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Theracell Advanced Biotechnology
S.A, Theracell Advanced Biotechnology LTD and IDNA Genomics Public Limited (collectively, “Theracell”) for the purchase by
the Company of the following assets (the “Assets”) owned by Theracell:
|
● |
50%
of the outstanding ownership rights and equity interests in Theracell Laboratories IKE (“Theracell IKE”) not currently
owned by the Company so that the Company shall own 100% of the outstanding equity interests of Theracell IKE; and |
|
|
|
|
● |
Certain
products (the “Products”), which include: (i) the manufacturing processes, algorithms, work instructions, test methods,
standard operating procedures and specifications for producing Tumor Infiltrating Lymphocytes (“TILs”) that meet current
Good Manufacturing Practice (cGMP) requirements that will enable the Company to potentially use this product as a platform for treating
a wide variety of solid tumors; (ii) a 3rd generation GMP lentivirus production process, which is part of a therapy manufacturing
process that will enable the Company to potentially treat Beta Thalassemia therapies; (iii) an oncolytic virus cell carrier platform
which will enable the Company to potentially develop treatments for an array of cancers; (iv) a process for the potential treatment
of mesenchymal stem cells for kidney disorders; (v) a process for controlled isolation of regenerative EVs derived from mesenchymal
stem cells for the potential treatment of kidney disorders; and (vi) bioxome encapsulated APIs for improved transdermal delivery
and bioavailability for the potential treatment of atopic dermatitis/wound healing; including Theracell’s rights, title and
interests in and to all intellectual property, including, but not limited to, patents, patent applications, know-how, materials,
licenses, permits and approvals relating to Products as further described in the Purchase Agreement. |
Pursuant
to the Purchase Agreement, in consideration for the purchase of the Assets, the Company will pay Theracell an aggregate purchase price
of $13,000
(the “Consideration”), which is equal
to the value of the Assets established with the assistance of a third-party valuation firm, less a debt adjustment in the amount of $10,324
which was owed (but fully impaired in the Company’s
financial statements) by Theracell to the Company (the “Debt”). The
aggregate Consideration will be paid by the Company as follows: (i) $400 will be paid to Theracell within 60 days after signing of the
Purchase Agreement, (ii) $250 will be paid to Theracell within one year after signing of the Purchase Agreement, and (iii) the remaining
amount (less any Debt) will be paid to Theracell in four equal annual payments beginning on December 30, 2025 and ending on December
30, 2028. As of the date of this quarterly report on Form 10-Q, the Company had paid Theracell $243. The Company accounted for the Purchase
agreement by recording the difference between the Consideration and Debt as research and development expenses, and the consideration
that exceeds the debt was recorded in short term or other long-term liabilities as appropriate.
Material
Definitive Agreement
On
August 9, 2024, the Company and Harley Street Healthcare Group (London) Plc Ltd. (“HSHG”) entered into a Strategic Partnership
Agreement (the “Agreement”) pursuant to which the Company and HSHG agreed to form a joint venture to collaborate in the clinical
development and commercialization of wellness and longevity-related services, including personalized preventative care and regenerative
therapies, which are to be offered on a subscription basis by HSHG in line with a planned offering of “Health & Wellness as
a Service” initially within the territory of the United Kingdom, the UAE, MENA, Canada, ASEAN, the Balkans, Africa, Latam and the
Indian Subcontinent (the “Territory”). Pursuant to the Agreement, any new joint venture entity to be formed (the “JV”)
will initially be owned 49% by the Company and 51% by HSHG. Thereafter, ownership of the JV entity will be based on each party’s
respective contributions, and control of the board of the JV entity will be based upon such percentage contributions. Until the parties
mutually agree to form the new JV entity, HSHG and the Company shall each carry out the respective tasks assigned to them for the implementation
of the project in accordance with the Agreement and the applicable work plan thereunder.
Pursuant
to the Agreement, HSHG agreed to invest (by the end of December 2024 for phase I) $5,000 in the Company’s shares of common stock
at a purchase price equal to the greater of (i) $10.3 per share (subject to adjustment for stock splits, consolidations and similar transactions)
or (ii) a 5% premium to the Nasdaq official closing price of the common stock of the Company at the time of HSHG’s investment.
Upon receipt by the Company of the $5,000 investment set forth above, HSHG will receive 485,437 three-year warrants to purchase 485,437
shares of the Company’s common stock at an exercise price equal to the greater of (i) $10.3 per share (subject to adjustment for
stock splits, consolidations and similar transactions) or (ii) a 10% premium to the Nasdaq official closing price of the Company’s
common stock. In addition, HSHG will have the option to provide up to $5,000 of additional funding for phase II, to be invested by December
31, 2025 in the Company’s shares of common stock under the same terms (the “Option”). The Option shall expire on the
one-year anniversary of the date which the Company receives the original investment from HSHG (the “Effective Date”). In
addition, following the Effective Date, HSHG will have the option to nominate a representative board member to join the Company’s
board of directors, subject to the Company obtaining the proper corporate approvals and the applicable rules and regulations of the Nasdaq
Stock Market.
The
Company shall contribute to the JV its intellectual property rights in the form of a license agreement to be entered into by the parties,
which will require that HSHG shall be solely responsible for payment of all costs of the manufacturing, distributing, marketing and/or
selling of the Company’s products within the Territory. In addition, the Company shall provide the know-how and tech transfer of
the Company’s products, and will support the JV and HSHG in the implementation of one or more products in the Territory, including
implementing the relevant Company quality management system, all as specified and detailed in the applicable work plan and the relevant
master services agreement. The Company will have the option to nominate a representative board member to join the JV and HSHG’s
board of directors, subject to HSHG obtaining the proper approval for adding a board member.
In
addition, each of the parties may provide additional funding in an amount to be mutually agreed by the parties, to cover the operations
costs of the project in accordance with the applicable work plan. Such additional investment may be in the form of an equity investment
for shares in the JV entity, a convertible loan, and/or procured services (the “Additional Investment”), if required (as
determined by the Parties) upon mutual agreement in order to continue the activities of the applicable project(s). The valuation of the
JV/any jointly controlled entities for the purposes of such Additional Investment will be mutually agreed by the parties or determined
with the assistance of an independent third-party expert to be mutually selected by the parties. Any Additional Investment by either party may result in
a dilution of the other party’s participating interest.
The
Company and HSHG shall have the right to purchase all of HSHG’s or the Company’s interest in the JV subject to all rules
and regulations to which it is then subject, including without limitation, the rules of any U.S. national securities exchange (“ORGS
Buy-Out”). In the event that the ORGS Buy-Out is implemented, then, for the purposes of the ORGS Buy-Out, the JV’s valuation
shall be determined by an independent third-party expert to be mutually selected by the parties.
As
of September 30, 2024 the JV entity had not been incorporated. As of the date of this quarterly report on Form 10-Q, no funds had yet
been received from HSHG.
NOTE
12 – LEGAL PROCEEDINGS
On
January 18, 2022, a complaint (the “Complaint”) was filed in the Tel Aviv District Court (the “Court”) against
the Company, Orgenesis Ltd (“the Israeli Subsidiary”), Prof. Sarah Ferber, Vered Caplan and Dr. Efrat Asa Kunik (collectively,
the “defendants”) by plaintiffs the State of Israel, as the owner of Chaim Sheba Medical Center at Tel Hashomer (“Sheba”),
and Tel Hashomer Medical Research, Infrastructure and Services Ltd. (collectively, the “plaintiffs”). In the Complaint, the
plaintiffs are seeking that the Court issue a declaratory remedy whereby the defendants are required to pay royalties to the plaintiffs
at the rate of 7% of the sales and 24% of any and all revenues in consideration for sublicenses related to any product, service or process
that contain know-how and technology of Sheba and any and all know-how and technology either developed or supervised by Prof. Ferber
in the field of cell therapy, including in the category of the point-of-care platform and any and all services and products in relation
to the defendants’ CDMO activity. In addition, the plaintiffs seek that the defendants provide financial statements and pay NIS
10,000 to the plaintiffs due to the royalty provisions of the license agreement, dated February 2, 2012, between the Israeli subsidiary
and Tel Hashomer Medical Research, Infrastructure and Services Ltd. (the “License Agreement”). The Complaint alleges that
the Company and the Israeli subsidiary used know-how and technology of Sheba and know-how and technology either developed or supervised
by Prof. Ferber while employed by Sheba in the field of cell therapy, including in the category of the point-of-care platform and the
services and products in relation to the defendants’ CDMO activity and are entitled to the payment of certain royalties pursuant
to the terms of the License Agreement. The defendants have filed their statements of defense responding to this Complaint, the Plaintiffs
filed their response and the parties are now conducting disclosure proceedings in accordance with Israel’s civil regulations. In
accordance with Israel’s civil regulations, the parties considered alternative means to resolve at least some of the disputes and
have consented to engage the services of a mutually agreeable mediator. The mediation is currently taking place. According to management’s
estimation, since a loss is not considered probable, no provision was made in the financial statements.
On
September 6, 2023, a claim (the “Claim”) was filed in the Tel Aviv District Court (the “Court”) against the Company,
the Israeli Subsidiary, Octomera LLC, Orgenesis Biotech Israel Ltd, Theracell Laboratories Private Company and Vered Caplan (collectively,
the “defendants”) by Ehud Almon (Plaintiff) for certain finders’ fees and / or royalties related to sales made by an
Octomera subsidiary to a Greek entity in the amount of $896 and also for other means of compensation. The Israeli Subsidiary and Vered
Caplan filed their statement of defense on January 28, 2024 claiming, inter alia, that the Plaintiff did not serve as a broker, but rather
served as the Greek entity’s representative and as such he is not entitled to compensation of any kind from the defendants. It
was also clarified that the defendants did not enter into a finder’s agreement with the Plaintiff. Additionally, the Israeli subsidiary
and Vered Caplan claimed that the Plaintiff concealed material information from the court, including the signed partnership agreement
between the Greek entity’s owner and the Plaintiff, as well as certain criminal charges brought against him in Greece. On February
22, 2024, the Plaintiff filed a request for service of process to deliver the Claim to the Company and the other defendants incorporated
outside of Israel. This request was denied on the same day. An appeal filed by the Plaintiff on the aforementioned decision was denied.
On May 27, 2024, the Plaintiff filed a new request for service of process to deliver the Claim to the Company and the other defendants
incorporated outside of Israel. On May 28, 2024 the request was accepted. The court ruled that the Claim be delivered via courier to
the Company and Octomera LLC, and delivered in accordance with the Hague Convention to Theracell Laboratories. After requesting a continuance,
on September 18, 2024, the Plaintiff filed an update that the Claim was
delivered to the Company and Octomera LLC on August 16, 2024. On the same day, the Claimant also filed a motion, petitioning that the
Claim will be delivered to Theracell Laboratories via the Company or via Vered Caplan, in order to minimize the costs of translating and
delivering the Claim to Greece. On October 7, 2024 Vered Caplan filed her opposition to the abovementioned motion, claiming that there
is no legal basis for the Claimant’s request, especially since the ruling regarding the service of process was made per the Plaintiff’s
request. On October 10, 2024 the Company filed its opposition to the request, on the same basis, mentioning, inter alia, that the claim
itself has no connection to Israel and that the Israeli courts are not the appropriate forum for the Plaintiff’s claims. Ruling
on the abovementioned motion is pending. According
to management’s estimation, since the likelihood of the Plaintiff winning the case is less than fifty percent, no provision was
made in the financial statements.
On
October 26, 2023, a complaint was filed in the Supreme Court of the State of New York by plaintiffs Southern Israel Bridging Fund Two
LP and Mr. Amir Hasidim, against the Company, seeking the payment of $1,150 together with interest in the amount of 6%. In the Complaint
plaintiffs alleged the amount provided to the Company was based on a Convertible Loan Agreement dated May 17, 2022, which provided for
a loan amount of $5,000. Notwithstanding the Convertible Loan Agreement, on August 21, 2023, Company sent the plaintiffs an offset notice
in light of the plaintiffs’ breach of obligations under the Convertible Loan Agreement and the damages caused to the Company as
a result of said breach. The Company counter sued as well, seeking damages for Plaintiff’s breach of contract, fraud and harassment.
Accordingly, the Company disputes whether it owes plaintiffs the amount sought in the Complaint.
On
November 1, 2023, a claim (the “Claim”) was filed in the Tel Aviv District Court (the “Court”) against the Company,
the Israeli Subsidiary, and Vered Caplan (collectively, the “Defendants”) by Fidelity Venture Capital Ltd. and Dror Atzmon
(together – the “Plaintiffs”). The claim is based on two agreements the Company entered into with the Plaintiffs on
November 2, 2016: (a) an unsecured convertible note agreements for an aggregate amount of NIS 1 million ($280). The loan bears a monthly
interest rate of 2% and will mature on May 1, 2017, unless converted earlier and (b) a consultation agreement which awarded the Plaintiffs
80 thousand warrants. The exercise price of the warrants and conversion price were fixed at $5.2 per share (pre-reverse stock split implemented
by the Company in November 2017). On April 27, 2017, and November 2, 2017, the Company entered into extension agreements through November
2, 2017 and May 2, 2018, respectively, in connection with the convertible note agreements. In March 2018, the Plaintiffs submitted a
notice of their intention to convert into shares the Company’s common stock, the principal amount of the loan, and accrued interest
of approximately $383 outstanding. In addition, the Plaintiffs exercised all the warrants awarded in the consultation agreement. In light
of the reverse stock split which took place in November 2017, the Company disagreed with the plaintiffs’ calculations regarding
the number of issuable shares of Common Stock. The Company responded to the notice and rejected these contentions in their entirety.
In April 2018, the Company terminated the agreements based on several claims, including mistake, intentional misrepresentation and bad
faith. Therefore, the Company deposited the shares in total amount of 10,798 issued under those agreements and the principal amount and
accrued interest of the loan in an escrow account. The deposit of the principal amount and accrued interest presented as restricted cash
in the balance sheet as of December 31, 2023. Based on the calculation difference, in their Claim, the Plaintiffs request damages in
the amount of NIS 40,140, and the issuance of 1,186,960 shares of the Company. The Defendants filed their statement of defense on April
15, 2024, in which they raised, among others, the aforementioned claims and additional procedural and substantial claims, including laches. The parties have agreed to start mediation
proceeding in connection with the Claim. According to management’s estimation, since the likelihood of the Plaintiffs winning the
case is less than fifty percent, no provision was made in the financial statements.
On
July 11, 2024 the Israeli subsidiary reached a settlement agreement regarding unpaid rentals sanctioned by the Tel Aviv Magistrate’s
court pursuant to which the subsidiary will pay the amount of NIS 427,000 (approximately $114) including VAT to the lessor of leased
premises no later than September 30, 2024, which includes a grace period for late payments. As of the date of this quarterly report on
Form 10-Q, the Company had paid all of the settlement amount less $12, and the lessor agreed to defer payment of the $12 to December 28, 2024. In the event that the Company fails to meet all of its obligations under the settlement agreement, the Company may be liable
to pay an additional NIS 211,000 (approximately $57) over and above the amount still due, in respect of claims for unpaid rentals made
by the lessor.
Except
as described above, the Company is not involved in any pending material legal proceedings.
NOTE
13 – SUBSEQUENT EVENTS
On
November 8, 2024, the two Belgian subsidiaries of the Company, viz. Orgenesis Belgium SRL and
Orgenesis Services SRL (“the Belgian subsidiaries”), petitioned the Liège Business Court in Belgium for allowing their
judicial reorganization pursuant to Article XX.41 of the Belgian Code of Economic Law. The petition follows the current inability of the
Belgian subsidiaries to pay employee payroll expenses and accounts payable. The Company has requested a 6-month reorganization period.
The Liège Business Court has agreed to consider the petition, and the next hearing will take place on November 22, 2024.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
(U.S.
Dollars in thousands, except share and loss per share amounts)
Forward-Looking
Statements
The
following discussion should be read in conjunction with the financial statements and related notes contained elsewhere in this Quarterly
Report, as well as our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the Securities and Exchange
Commission (the “SEC”) on April 15, 2024. Certain statements made in this discussion are “forward-looking statements”
within the meaning of 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities
Exchange Act of 1934, as amended. These statements are based upon beliefs of, and information currently available to, the Company’s
management as well as estimates and assumptions made by the Company’s management. Readers are cautioned not to place undue reliance
on these forward-looking statements, which are only predictions and speak only as of the date hereof. When used herein, the words “anticipate,”
“believe,” “estimate,” “expect,” “forecast,” “future,” “intend,”
“plan,” “predict,” “project,” “target,” “potential,” “will,”
“would,” “could,” “should,” “continue” or the negative of these terms and similar expressions
as they relate to the Company or the Company’s management identify forward-looking statements. Such statements reflect the current
view of the Company with respect to future events and are subject to risks, uncertainties, assumptions, and other factors, including
the risks relating to the Company’s business, industry, and the Company’s operations and results of operations. Other factors
that may cause actual results to differ materially from current expectations include, among other things, those listed under Part II,
Item 1A. “Risk Factors” and elsewhere in this Quarterly Report. Should one or more of these risks or uncertainties materialize,
or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated,
expected, intended, or planned. Given these uncertainties, you should not place undue reliance on these forward-looking statements.
Although
the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee future
results, levels of activity, performance, or achievements. Except as required by applicable law, including the securities laws of the
United States, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results.
Our
financial statements are prepared in accordance with accounting principles generally accepted in the United States (“GAAP”).
These accounting principles require us to make certain estimates, judgments, and assumptions. We believe that the estimates, judgments,
and assumptions upon which we rely are reasonable based upon information available to us at the time that these estimates, judgments,
and assumptions are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities as of
the date of the financial statements as well as the reported amounts of revenues and expenses during the periods presented. Our financial
statements would be affected to the extent there are material differences between these estimates and actual results. The following discussion
should be read in conjunction with our financial statements and notes thereto appearing elsewhere in this report.
Unless
otherwise indicated or the context requires otherwise, the words “we,” “us,” “our,” the “Company,”
“our Company” or “Orgenesis” refer to Orgenesis Inc., a Nevada corporation, and our majority or wholly-owned
subsidiaries, Orgenesis Korea Co. Ltd. (the “Korean Subsidiary”); Orgenesis Belgium SRL, a Belgian-based entity (the “Belgian
Subsidiary”); Orgenesis Services SRL, a Belgian-based entity (“Orgenesis Services SRL”); Orgenesis Ltd., an Israeli
corporation (the “Israeli Subsidiary”); Orgenesis Maryland LLC, a Maryland limited liability company (the “Maryland
Subsidiary”); Orgenesis Switzerland Sarl, (the “Swiss Subsidiary”); Orgenesis Biotech Israel Ltd. (“OBI”);
Koligo Therapeutics Inc., a Kentucky corporation (“Koligo”); Tissue Genesis International LLC (“Tissue Genesis”)
a Texas limited liability company; Orgenesis Germany GmbH (the “German Subsidiary”); Orgenesis CA, Inc. (the “California
Subsidiary”); Mida Biotech BV (the “Dutch Subsidiary”); Orgenesis Australia PTY LTD (the “Australian Subsidiary”);
Orgenesis Italy SRL (the “Italian Subsidiary”), Theracell Laboratories Private Company (“Theracell Laboratories”),
a Greek company, Orgenesis Austria GmbH, an Austrian company; ORGS POC CA Inc, a Delaware company; and Octomera LLC, a Delaware limited
liability company.
Business
Overview
We
are a global biotech company working to unlock the potential of CGTs in an affordable and accessible format. CGTs can be centered on
autologous (using the patient’s own cells) or allogenic (using master banked donor cells) and are part of a class of medicines
referred to as advanced therapy medicinal products, or ATMPs. We are mostly focused on autologous therapies that can be manufactured
under processes and systems that are developed for each therapy using a closed and automated approach that is validated for compliant
production near the patient for treatment of the patient at the point of care, or POCare. This approach has the potential to overcome
the limitations of traditional commercial manufacturing methods that do not translate well to commercial production of advanced therapies
due to their cost prohibitive nature and complex logistics to deliver such treatments to patients (ultimately limiting the number of
patients that can have access to, or can afford, these therapies).
To
achieve these goals, we have developed a collaborative worldwide network of research institutes and hospitals who are engaged in the
POCare model, or our POCare Network, and a pipeline of licensed POCare advanced therapies that can be processed and produced under such
closed and automated processes and systems, or POCare Therapies. We are developing our pipeline of advanced therapies with the goal of
entering into out-licensing agreements for these therapies.
We
have two operating segments – our POCare Services and our therapeutic development operations. We conduct our core POCare operations
through our wholly-owned subsidiary Octomera LLC which was a consolidated subsidiary of ours until June 30, 2023 and which became a consolidated
subsidiary again effective January 29, 2024 when we entered into a unit purchase agreement pursuant to which we acquired all of the equity
interests of Octomera LLC.
Octomera
segment (mainly POCare Services)
The
POCare Services that we and our affiliated entities perform include:
● |
Process
development of therapies, process adaptation, and optimization inside the OMPULs, or “OMPULization”; |
|
|
● |
Adaptation
of automation and closed systems to serviced therapies; |
|
|
● |
Incorporation
of the serviced therapies compliant with GMP in the OMPULs that we designed and built; |
|
|
● |
Tech
transfers and training of local teams for the serviced therapies at the POCare Centers; |
|
|
● |
Processing
and supply of the therapies and required supplies under GMP conditions within our POCare Network, including required quality control
testing; |
The
POCare Services are performed in decentralized hubs that provide harmonized and standardized services to customers, or POCare Centers.
We are working to expand the number and scope of our POCare Centers. We believe that this provides an efficient and scalable pathway
for CGT therapies to reach patients rapidly at lowered costs. Our POCare Services are designed to allow rapid capacity expansion while
integrating new technologies to bring together patients, doctors and industry partners with a goal of achieving standardized, regulated
clinical development and production of therapies.
Therapies
segment (POCare Therapies)
While
the biotech industry struggles to determine the best way to lower the cost of goods and enable CGTs to scale, the scientific community
continues to advance and push the development of such therapies to new heights. Clinicians and researchers are excited by many new tools
(such as new generations of industrial viruses and big data analysis for genetic and molecular data) and technologies (CRISPR, mRNA,
etc.) available, often at a low cost, to perform advanced research in small labs. Most new therapies arise from research at academic
institutions or at small spinouts from such institutions. Though such research efforts may manage to progress into a clinical stage,
utilizing lab- or hospital-based production solutions, they generally lack the resources to continue the development of such drugs to
market approval.
Historically,
drug/therapeutic development has required investments of hundreds of millions of dollars to be successful. One significant cause for
the high cost is that each therapy often requires unique production facilities and technologies that must be subcontracted or built.
Furthermore, the cost of production during the clinical stage is extremely expensive, and the cost of the clinical trial itself is very
high. Given these financial restraints, researchers and institutions hope to out-license their therapeutic products to large biotech
companies or to spin out new companies and conduct large fundraising rounds. In many cases, however, they lack the resources and the
capability to de-risk their therapeutic candidates enough to be attractive for such fundings or partnership.
Our
POCare Network is an alternative to the traditional pathway of drug development. Orgenesis works closely with many such institutes and
is in close contact with researchers in the field. The partnerships with leading hospitals and research institutes gives us a deep insight
as to the developments in the field, as well as the market potential, the regulatory landscape and optimal clinical pathway to get these
products to market.
The
ability to produce these products at low cost allows for an expedited development process, and partnership with hospitals around the
globe allows for joint grants and lower costs of clinical development. The POCare Therapies division reviews many therapies available
for out-licensing and selects the ones they believe have the highest market potential and chance of clinical success and can benefit
the most from a point of care approach. It assesses such issues by utilizing its global POCare Network and its internal know-how accumulated
over a decade of involvement in the field.
The
goal of this in-licensing is to quickly adapt such therapies to a point-of- care approach through regional partnerships, and to out-license
the products for market approval in non-core geographical regions. This approach lowers overall development costs by minimizing our pre-clinical
development costs and enabling us to receive additional funding from grants and/or payments by regional partners.
Significant
developments during the nine-months ended September 30, 2024
On
September 27, 2023, we received a notice from the Listing Qualifications Staff (“Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”)
stating that the bid price of the Common Stock had closed at less than $1.00 per share over the previous 30 consecutive business days,
and, as a result, did not comply with Listing Rule 5550(a)(2) (the “Bid Price Rule”). On April 17, 2024, we received a notice
(the “Notice”) from the Staff which stated that it could not accept a plan to regain compliance and the Staff stated that
our securities would be delisted from The Nasdaq Capital Market unless we timely requested a hearing before a Nasdaq Hearings Panel (the
“Panel”) to address the deficiencies and present a plan to regain compliance. As permitted by the Notice, we timely requested
a hearing before the Panel, which request stayed any further delisting action by the Staff pending the ultimate outcome of the hearing
and the expiration of any extension that may be granted by the Panel. On June 6, 2024, we met with the Panel regarding our potential
delisting from The Nasdaq Stock Market as a result of our violation of the Bid Price Rule and non-compliance with the equity requirement
in Listing Rule 5550(b)(1) (the “Equity Rule”) or any of the alternative requirements in Listing Rule 5550(b). On June 8,
2024, we received the Panel’s decision which granted us until October 14, 2024 to regain compliance with the Bid Price and Equity
Rules. On October 17, 2024, Nasdaq notified the Company that the Panel had determined to delist the Company’s Common Stock and
that trading of the Company’s Common Stock will be suspended at the open of trading on October 21, 2024. In connection with the
Nasdaq delisting notice, Nasdaq will complete the delisting by filing a Form 25 Notification of Delisting with the U.S. Securities and
Exchange Commission (the “SEC”) after applicable appeal periods have lapsed. The Company’s Common Stock began trading
under “ORGS” on the OTCQX with the open of the markets on October 21, 2024.
On
January 29, 2024 (“Closing” or “Transaction date” or “Reconsolidation date”), we and Metalmark Capital
Partners (“MM”) entered into a Unit Purchase Agreement (the “MM UPA”), pursuant to which we acquired all of the
preferred units of Octomera previously owned by MM and reconsolidated Octomera into our accounts with immediate effect (the “MM
acquisition”). As consideration for the MM Acquisition, we and MM agreed to the following consideration:
|
● |
Royalty
Payments: If Octomera and its subsidiaries generate Net Revenue during the three-year period 2025-2027, then we will pay 5% of Net
Revenues to MM pursuant to the MM UPA. |
|
● |
Milestone
Payments: If we sell Octomera within ten years from the date of the Closing at a price that is more than $40 million excluding consideration
for certain Excluded Assets as per the UPA, then we will pay MM 5% of the net proceeds of that sale. |
Pursuant
to the MM acquisition, MM’s designated members of the Board of Managers of Octomera resigned, and we amended the Second Amended
and Restated Limited Liability Company Agreement of Octomera (the “Octomera LLC Agreement”) to be a single member agreement
reflecting the MM acquisition, such that MM no longer (i) was a member of Octomera or a party to the Octomera LLC Agreement, or (ii)
had the right to appoint members of the board of managers of Octomera.
In
addition, 10 secured promissory notes between Orgenesis Maryland LLC and MM, reflecting an aggregate outstanding principal amount of
$2,600 (the “Notes”), were amended to, among other things, extend the maturity thereof to January 29, 2034 and to terminate
the security interest granted by Orgenesis Maryland LLC in favor of MM that secured the obligations under the Notes.
On
February 14, 2024, following a claim for payment by employees of OBI (a fully owned subsidiary of Octomera) of past salaries due, the
district court in Haifa, Israel appointed a trustee to run the affairs of OBI. As a result of this appointment, effective February 14,
2024, we no longer control OBI and have ceased to consolidate the results of OBI into our consolidated results. We recognized a loss
as a result of the deconsolidation of $66. We do not currently believe that rehabilitation of OBI is possible, and we purchased certain
of OBI’s equipment.
On
March 3, 2024, we entered into a Securities Purchase Agreement with certain accredited investors, pursuant to which we agreed to issue
and sell, in a private placement, 227,272 shares of our Common Stock at a purchase price of $10.3 per share, Warrants to purchase up
to 227,272 shares of Common Stock at an exercise price of $15.0 per share, and Warrants to purchase up to 227,272 shares of Common Stock
at an exercise price of $20.0 per share, all such Warrants exercisable immediately and expiring five years from the date of their issuance.
We received gross proceeds of approximately $2,300 before deducting related offering expenses. The Offering closed on March 5, 2024.
On
April 5, 2024, we entered into an Asset Purchase and Strategic Collaboration Agreement (the “Purchase Agreement”) with Griffin
Fund 3 BIDCO, Inc. (“Germfree”), for the sale by us of five OMPULs to Germfree, which are to be incorporated into Germfree’s
lease fleet and leased back to us or to third-party lessees designated by us. Pursuant to the Purchase Agreement, and subject to the
terms and conditions set forth therein, in consideration for the purchase of the OMPULs, the Orgenesis Quality Management Systems Framework
(“OQMSF”) and related intellectual property rights, Germfree is to pay us an aggregate purchase price of $8,340 subject to
adjustment through a verification mechanism set forth in the Purchase Agreement. Pursuant to the Purchase Agreement, Germfree has paid
us $6,720 as of September 30, 2024.
On
May 10, 2024, we entered into a Securities Purchase Agreement with certain accredited investors, pursuant to which we agreed to issue
and sell, in a private placement, 15,000 shares of our Common Stock at a purchase price of $10.3 per share, Warrants to purchase up to
15,000 shares of Common Stock at an exercise price of $15.0 per share, and further Warrants to purchase up to 15,000 shares of Common
Stock at an exercise price of $20.0 per share, all such Warrants exercisable immediately and expiring five years from their date of issuance.
We received gross proceeds of approximately $154 before deducting related offering expenses. The Offering closed on May 10, 2024.
On
May 21, 2024 we entered into debt exchange agreements with three convertible debt holders pursuant to which a total of $16,007 of outstanding
principal and accrued interest was exchanged for the right to receive an aggregate of 1,577,695 shares of common stock, par value $0.0001
per share, of our Common Stock, of which $14,860 was exchanged for shares at an exchange price of $10.3 per share of Common Stock and
$1,147 was exchanged for shares at an exchange price of $8.5 per share of Common Stock.
On
July 10, 2024, we entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Broaden Bioscience and Technology
Corp. (“Broaden”) for the purchase by the Company of the following assets (the “Assets”): The process and algorithms
developed by Broaden for processing CAR-T, RACE CAR-T and all oncology products that will enable us to develop and sell treatments to
third parties, which include Broaden’s rights, title and interests in and to all intellectual property, including, but not limited
to, patents, patent applications, know-how, materials, licenses, permits and approvals related thereto. Pursuant to the Purchase Agreement,
in consideration for the purchase of the Assets, we will pay Broaden an amount equal to the value of the Assets established by a third
party valuation firm not to exceed $11,000 (the “Consideration”), less a debt adjustment relating to $10,767 owed to us by
Broaden for work performed and invoiced between August 2022 and May 2023 (the “Debt”), as detailed in the Purchase Agreement.
The Consideration that exceeds the Debt will be payable at our election in shares of our common stock at a price of $30.0 per share or
10% above the market price at such time it is paid, whichever is higher, or a note with amortization in 24 months from the date of the
Purchase Agreement, including prepayment provisions.
On
July 12, 2024, we entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Theracell Advanced Biotechnology
S.A, Theracell Advanced Biotechnology LTD and IDNA Genomics Public Limited (collectively, “Theracell”) for the purchase by
us of the following assets (the “Assets”) owned by Theracell:
|
● |
50%
of the outstanding ownership rights and equity interests in Theracell Laboratories IKE (“Theracell IKE”) not currently
owned by us so that we shall own 100% of the outstanding equity interests of Theracell IKE; and |
|
|
|
|
● |
Certain
products (the “Products”), which include: (i) the manufacturing processes, algorithms, work instructions, test methods,
standard operating procedures and specifications for producing Tumor Infiltrating Lymphocytes (“TILs”) that meet current
Good Manufacturing Practice (cGMP) requirements that will enable the Company to potentially use this product as a platform for treating
a wide variety of solid tumors; (ii) a 3rd generation GMP lentivirus production process, which is part of a therapy manufacturing
process that will enable the Company to potentially treat Beta Thalassemia therapies; (iii) an oncolytic virus cell carrier platform
which will enable the Company to potentially develop treatments for an array of cancers; (iv) a process for the potential treatment
of mesenchymal stem cells for kidney disorders; (v) a process for controlled isolation of regenerative EVs derived from mesenchymal
stem cells for the potential treatment of kidney disorders; and (vi) bioxome encapsulated APIs for improved transdermal delivery
and bioavailability for the potential treatment of atopic dermatitis/wound healing; including Theracell’s rights, title and
interests in and to all intellectual property, including, but not limited to, patents, patent applications, know-how, materials,
licenses, permits and approvals relating to Products as further described in the Purchase Agreement. |
Pursuant
to the Purchase Agreement, in consideration for the purchase of the Assets, we will pay Theracell an aggregate purchase price of $13,000
(the “Consideration”), which is equal to the value of the Assets established by a third-party valuation firm, less a debt
adjustment in the amount of $10,324 which was owed by Theracell to us (the “Debt”). The aggregate Consideration will be paid
by us as follows: (i) $400 will be paid to Theracell within 60 days after signing of the Purchase Agreement, (ii) $250 will be paid to
Theracell within one year after signing of the Purchase Agreement, and (iii) the remaining amount (less any Debt) will be paid to Theracell
in four equal annual payments beginning on December 30, 2025 and ending on December 30, 2028. As of the date of this quarterly report
on Form 10-Q, we had paid Theracell $243.
On
August 9, 2024, we and Harley Street Healthcare Group (London) Plc Ltd. (“HSHG”) entered into a Strategic Partnership Agreement
(the “Agreement”) pursuant to which the Company and HSHG agreed to form a joint venture to collaborate in the clinical development
and commercialization of wellness and longevity-related services, including personalized preventative care and regenerative therapies,
which are to be offered on a subscription basis by HSHG in line with a planned offering of “Health & Wellness as a Service”
initially within the territory of the United Kingdom, the UAE, MENA, Canada, ASEAN, the Balkans, Africa, Latam and the Indian Subcontinent
(the “Territory”). Pursuant to the Agreement, any new joint venture entity to be formed (the “JV”) will initially
be owned 49% by us and 51% by HSHG. Thereafter, ownership of the JV entity will be based on each party’s respective contributions,
and control of the board of the JV entity will be based upon such percentage contributions. Until the parties mutually agree to form
the new JV entity, HSHG and we shall each carry out the respective tasks assigned to them for the implementation of the project in accordance
with the Agreement and the applicable work plan thereunder.
Pursuant
to the Agreement, HSHG agreed to invest (by the end of December 2024 for phase I) $5,000 in our shares of common stock at a purchase
price equal to the greater of (i) $10.3 per share (subject to adjustment for stock splits, consolidations and similar transactions) or
(ii) a 5% premium to the Nasdaq official closing price of our common stock at the time of HSHG’s investment. Upon receipt by us
of the $5,000 investment set forth above, HSHG will receive 485,437 three-year warrants to purchase 485,437 shares of our common stock
at an exercise price equal to the greater of (i) $10.3 per share (subject to adjustment for stock splits, consolidations and similar
transactions) or (ii) a 10% premium to the Nasdaq official closing price of our common stock.
As
of September 30, 2024 the JV entity had not been incorporated. As of the date of this quarterly report on Form 10-Q, no funds had yet
been received from HSHG.
On
September 20, 2024, we implemented a 1-for-10 reverse
stock split (the “Reverse Split”) of our authorized and outstanding shares of Common Stock. All share and per share amounts
in these financial statements have been retroactively adjusted to reflect the reverse split as if it had been effected prior to the earliest
financial statement period included herein. Following the Reverse Split, the number of authorized
shares of common stock that we are authorized to issue from time to time is 14,583,333 shares.
Results
of Operations
Comparison
of the Three Months Ended September 30, 2024 to the Three Months Ended September 30, 2023.
The
following table presents our results of operations for the three months ended September 30, 2024 and 2023:
| |
Three-Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Revenues | |
$ | 347 | | |
$ | 110 | |
Cost of revenues | |
| 585 | | |
| 139 | |
Gross profit | |
| (238 | ) | |
| (29 | ) |
Cost of development services and research and development | |
| 4,523 | | |
| 808 | |
Amortization of intangible assets | |
| 196 | | |
| 153 | |
Change in Contingent consideration | |
| 81 | | |
| - | |
Selling, general and administrative expenses | |
| 2,664 | | |
| 1,245 | |
Impairment expense | |
| 692 | | |
| - | |
Operating loss | |
| 8,394 | | |
| 2,235 | |
Other expense (income), net | |
| 122 | | |
| (2 | ) |
Financial expenses, net | |
| 718 | | |
| 545 | |
Share in net loss of associated company | |
| - | | |
| 553 | |
Loss before income taxes | |
| - | | |
| 3,331 | |
Tax expense | |
| - | | |
| 394 | |
Net loss | |
$ | 9,234 | | |
$ | 3,725 | |
Revenues
Our
revenues for the three months ended September 30, 2024 were $347, as compared to $110 for the three months ended September 30, 2023,
representing an increase of 215%. The increase was as a result of work completed and payments received on cell processing development
and hospital services.
Expenses
Cost
of revenue
| |
Three-Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Salaries and related expenses | |
$ | 154 | | |
$ | 94 | |
Stock-based compensation | |
| 2 | | |
| 1 | |
Professional fees and consulting services | |
| 67 | | |
| 4 | |
Raw materials | |
| 33 | | |
| 5 | |
Depreciation expenses, net | |
| 148 | | |
| 5 | |
Other expenses | |
| 181 | | |
| 30 | |
Total | |
$ | 585 | | |
$ | 139 | |
Cost
of revenues for the three months ended September 30, 2024 were $585, as compared to $139 for the three months ended September 30, 2023,
representing an increase of 321%. The increase was mainly attributable to Octomera segment related cost of revenues which, since the
reconsolidation of Octomera, were included in our results. In the three months ended September 30, 2023, Octomera was not a consolidated
subsidiary and its cost of revenues were therefore excluded from our results. Octomera segment cost of revenues declined in the three
months ended September 30, 2024 compared to the three months ended September 30, 2023 particularly as a result of the deconsolidation
of OBI and reduced activities at the Korean subsidiary.
Cost
of development services and research and development expenses
| |
Three Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Salaries and related expenses | |
$ | 1,515 | | |
$ | 669 | |
Stock-based compensation | |
| 50 | | |
| 24 | |
Professional fees and consulting services | |
| 729 | | |
| (38 | ) |
Lab expenses | |
| 5 | | |
| 22 | |
Depreciation expenses, net | |
| 186 | | |
| 29 | |
Other research and development expenses | |
| 2,121 | | |
| 171 | |
Less – grant | |
| (83 | ) | |
| (69 | ) |
Total | |
$ | 4,523 | | |
$ | 808 | |
Cost
of development services and research and development for the three months ended September 30, 2024 were $4,523, as compared to $808 for
the three months ended September 30, 2023, representing an increase of 460%.
The
increase was mainly attributable to Octomera segment related expenses, which, since the reconsolidation of Octomera, were included in
our results. In the three months ended September 30, 2023, Octomera was not a consolidated subsidiary and its cost of revenues were therefore
excluded from our results. In addition, professional fees and consulting services and other research and development expenses increased
as a result of the Asset Purchase Agreements referred to in Note 11. Octomera segment cost of development services and research and development
expenses revenues declined in the three months ended September 30, 2024 compared to the three months ended September 30, 2023 particularly
as a result of the deconsolidation of OBI and reduced activities at the Korean subsidiary.
Selling,
General and Administrative Expenses
| |
Three-Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Salaries and related expenses | |
$ | 865 | | |
$ | 259 | |
Stock-based compensation | |
| 32 | | |
| 53 | |
Accounting and legal fees | |
| 690 | | |
| 460 | |
Professional fees | |
| 196 | | |
| 134 | |
Rent and related expenses | |
| 125 | | |
| 13 | |
Business development | |
| 342 | | |
| 60 | |
Depreciation expenses, net | |
| 8 | | |
| 4 | |
Other general and administrative expenses | |
| 406 | | |
| 262 | |
Total | |
$ | 2,664 | | |
$ | 1,245 | |
Selling,
general and administrative expenses for the three months ended September 30, 2024 were $2,664, as compared to $1,245 for the three months
ended September 30, 2023, representing an increase of 114%. The increase was mainly attributable to Octomera segment related expenses,
which, since the reconsolidation of Octomera, were included in our results. In the three months ended September 30, 2023, Octomera was
not a consolidated subsidiary and its cost of revenues were therefore excluded from our results. Octomera segment cost of selling, general
and administration expenses declined in the three months ended September 30, 2024 compared to the three months ended September 30, 2023
particularly as a result of the deconsolidation of OBI and reduced activities at the Korean subsidiary.
Financial
Expenses, net
| |
Three-Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Interest expense on convertible loans and loans | |
$ | 1,033 | | |
$ | 611 | |
Foreign exchange loss, net | |
| (300 | ) | |
| (69 | ) |
Other expenses (income) | |
| (15 | ) | |
| 3 | |
Total | |
$ | 718 | | |
$ | 545 | |
Financial
expenses, net for the three months ended September 30, 2024 were $718, as compared to $545 for the three months ended September 30, 2023,
representing an increase of 32%. The increase was mainly due to finance expenses incurred on warrants issued in the three months ended
September 30, 2024 granted to loan holders.
Comparison
of the Nine Months Ended September 30, 2024 to the Nine Months Ended September 30, 2023.
The
following table presents our results of operations for the nine months ended September 30, 2024 and 2023:
| |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Revenues | |
$ | 734 | | |
$ | 365 | |
Cost of revenues | |
| 1,615 | | |
| 6,093 | |
Gross profit | |
| (881 | ) | |
| (5,728 | ) |
Cost of development services and research and development | |
| 8,382 | | |
| 7,616 | |
Amortization of intangible assets | |
| 575 | | |
| 568 | |
Change in Contingent consideration | |
| 263 | | |
| - | |
Selling, general and administrative expenses | |
| 10,781 | | |
| 32,989 | |
Impairment expense | |
| 692 | | |
| - | |
Operating loss | |
| 21,574 | | |
| 46,901 | |
Other income, net | |
| 114 | | |
| (4 | ) |
Loss from extinguishment in connection with convertible loan | |
| 141 | | |
| 283 | |
Credit loss on convertible loan receivable | |
| - | | |
| 2,688 | |
Financial expenses, net | |
| 2,385 | | |
| 1,918 | |
Convertible loans induced conversion expenses | |
| 4,304 | | |
| - | |
Share in net loss of associated company | |
| - | | |
| 552 | |
Loss from deconsolidation of Octomera | |
| 66 | | |
| 5,343 | |
Loss before income taxes | |
| 28,584 | | |
| 57,681 | |
Tax expense | |
| 53 | | |
| 614 | |
Net loss | |
$ | 28,637 | | |
$ | 58,295 | |
Revenues
Our
revenues for the nine months ended September 30, 2024 were $734, as compared to $365 for the nine months ended September 30, 2023, representing
an increase of 101%. The increase was as a result of work completed and payments received on cell processing development and hospital
services.
Expenses
Cost
of revenues
| |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Salaries and related expenses | |
$ | 585 | | |
$ | 2,298 | |
Stock-based compensation | |
| 4 | | |
| 4 | |
Professional fees and consulting services | |
| 107 | | |
| 1,882 | |
Raw materials | |
| 86 | | |
| 715 | |
Depreciation expenses, net | |
| 512 | | |
| 477 | |
Other expenses | |
| 321 | | |
| 717 | |
Total | |
$ | 1,615 | | |
$ | 6,093 | |
Cost
of revenues for the nine months ended September 30, 2024 were $1,615, as compared to $6,093 for the nine months ended September 30, 2023,
representing a decrease of 73%. The decrease was mainly attributable to reduced Octomera segment cost of revenues, particularly as a
result of the deconsolidation of OBI and reduced activities at the Korean subsidiary.
Cost
of development services and research and development expenses
| |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Salaries and related expenses | |
$ | 4,438 | | |
$ | 4,153 | |
Stock-based compensation | |
| 135 | | |
| 187 | |
Professional fees and consulting services | |
| 440 | | |
| 1,563 | |
Lab expenses | |
| 102 | | |
| 326 | |
Depreciation expenses, net | |
| 460 | | |
| 285 | |
Other research and development expenses | |
| 3,062 | | |
| 1,312 | |
Less – grant | |
| (255 | ) | |
| (210 | ) |
Total | |
$ | 8,382 | | |
$ | 7,616 | |
Cost
of development services and research and development for the nine months ended September 30, 2024 were $8,382, as compared to $7,616
for the nine months ended September 30, 2023, representing an increase of 10%.
The
increase in salaries and related expenses is mainly attributable to our accounting for Octomera segment cost of development services
and research and development expenses from the reconsolidation date compared to accounting for such expenses in 2023 until the deconsolidation
of Octomera. Professional fees and consulting services declined as a result of cost savings. Other research and development expenses
increased mainly as a result of the Asset Purchase Agreements referred to in Note 11.
Selling,
General and Administrative Expenses
| |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Salaries and related expenses | |
$ | 2,659 | | |
$ | 2,520 | |
Stock-based compensation | |
| 160 | | |
| 197 | |
Accounting and legal fees | |
| 2,385 | | |
| 2,804 | |
Professional fees | |
| (143 | ) | |
| 1,020 | |
Rent and related expenses | |
| 275 | | |
| 127 | |
Business development | |
| 1,227 | | |
| 421 | |
Depreciation expenses, net | |
| 78 | | |
| 36 | |
Other general and administrative expenses | |
| 1,415 | | |
| 1,497 | |
Credit losses | |
| 2,725 | | |
| 24,367 | |
Total | |
$ | 10,781 | | |
$ | 32,989 | |
Selling,
general and administrative expenses for the nine months ended September 30, 2024 were $10,781, as compared to $32,989 for the nine months
ended September 30, 2023, representing a decrease of 67%.
The
decrease was mainly as a result of a decrease in credit losses incurred in the nine months ended September 30, 2024 compared to the nine
months ended September 30, 2023, mainly in the Octomera segment, offset by an increase in business development expenses as a result of
warrants granted to advisers.
Credit
Loss on Convertible Loan Receivable
| |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Credit loss on convertible loans | |
$ | - | | |
$ | 2,688 | |
Credit
losses for the nine months ended September 30, 2024 were $0 compared to $2,688 for the nine months ended September 30, 2023. This was
attributable to a provision created for a possible credit loss on a loan in the nine months ended September 30, 2023.
Financial
Expenses, net
| |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Interest expense on convertible loans and loans | |
$ | 2,474 | | |
$ | 1,740 | |
Foreign exchange loss (gain), net | |
| (55 | ) | |
| 173 | |
Other expenses (income) | |
| (34 | ) | |
| 5 | |
Total | |
$ | 2,385 | | |
$ | 1,918 | |
Financial
expenses, net for the nine months ended September 30, 2024 were $2,385, as compared to $1,918 for the nine months ended September 30,
2023, representing an increase of 24%. The increase was mainly due to interest on new loan agreements entered into and finance expenses
incurred on warrants issued to loan holders.
Working
Capital
| |
As of | |
| |
September 30, 2024 | | |
December
31, 2023 | |
| |
(in thousands) | |
Current assets | |
$ | 2,519 | | |
$ | 4,076 | |
Current liabilities | |
| 36,049 | | |
| 16,407 | |
Working capital | |
$ | (33,530 | ) | |
$ | (12,331 | ) |
Current
assets decreased by $1,557 between December 31, 2023 and September 30, 2024 The decrease was mainly attributable to a decline in cash
and cash equivalents, prepaid expenses, and receivables from related parties.
Current
liabilities increased by $19,642 between December 31, 2023 and September 30, 2024 The increase was mainly attributable to:
|
● |
the
reconsolidation of Octomera which included an increase in accounts payable, accrued expenses and other payables, employees and related
payables, and advance payments on account of grants; |
|
|
|
|
● |
the
deconsolidation of OBI where we recorded an increase in accounts payable to related parties; |
|
|
|
|
● |
the
Germfree receipt which was recorded in current liabilities. |
|
|
|
|
● |
Additional
non-convertible short term loan agreements entered into. |
The
above increases were offset by a decline in current maturities of convertible loans, converted to equity.
Liquidity
and Financial Condition
| |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
| |
| | |
| |
Net loss | |
$ | (28,637 | ) | |
$ | (58,295 | ) |
| |
| | | |
| | |
Net cash used in operating activities | |
| (14,978 | ) | |
| (14,335 | ) |
Net cash used in investing activities | |
| 73 | | |
| (3,645 | ) |
Net cash provided by financing activities | |
| 14,560 | | |
| 12,393 | |
Increase in cash and cash equivalents | |
$ | (345 | ) | |
$ | (5,587 | ) |
During
the nine-month ended September 30, 2024, we funded our operations from operations as well as from proceeds raised from equity and debt
offerings.
Net
cash used in operating activities for the nine months ended September 30, 2024 was approximately $14,978, as compared to net cash used
in operating activities of approximately $14,335 for the nine months ended September 30, 2023.
The
change was mainly as a result of:
●
a net loss of $28,637 for the nine months ended September 30, 2024 compared to a net loss of $58,295 for the nine months ended
September 30, 2023;
●
non-cash items incurred in the nine months ended September 30, 2023 that were not incurred in the nine months ended September 30,
2024
Net
cash provided by investing activities for the nine months ended September 30, 2024 was approximately $73, as compared to net cash used
in investing activities of approximately $3,645 for the nine months ended September 30, 2023. The change was mainly as a result of a
decline in purchases of property and equipment and the cash impact from the deconsolidation of Octomera which incurred in the nine months
ended September 30, 2023 not incurred in the nine months ended September 30, 2024.
Net
cash provided by financing activities for the nine months ended September 30, 2024 was approximately $14,560, as compared to net cash
provided by financing activities of approximately $12,393 for the nine months ended September 30, 2023. The change was mainly attributable
to proceeds raised from equity investments and warrant exercises in the amount of $2,556 in the nine months ended September 30, 2024
as compared to $4,341 in the nine months ended September 30, 2023. In addition, in the nine months ended September 30, 2024, we raised
convertible loans in the amount of $75 compared to $5,660 in the nine months ended September 30, 2023, These decreases were offset by
the receipt of $6,720 from Germfree and non-convertible loans received in the amount of $4,670 in the nine months ended September 30,
2024 compared to $425 received in the nine months ended September 30, 2023.
Liquidity
& Capital Resources Outlook
Through
September 2024, we had an accumulated deficit of $204,411 and for the nine months ended September 30, 2024 incurred negative operating cashflows
of $14,978. Our activities have been funded by generating revenue, proceeds from loan agreements, and through offerings of our securities.
There is no assurance that our business will generate sustainable positive cash flows to fund our operations.
The
estimation and execution uncertainty regarding our future cash flows and management’s judgments and assumptions in estimating these
cash flows is a significant estimate. Those assumptions include reasonableness of the forecasted revenue, operating expenses, and uses
and sources of cash.
Due
to our financial position, we will need to seek additional financing, refinance or amend the terms of existing convertible loans, and/or
postpone expenses that are not based on firm commitments. In order to fund our operations until such time that we can generate sustainable
positive cash flows, we will need to raise additional funds. As of the date of this report, we have assessed our financial condition
and concluded that based on our current and projected cash resources and commitments, as well as other factors mentioned above, there
is substantial doubt about our ability to continue as a going concern. We are planning to raise additional capital to continue our operations
and to repay our outstanding loans when they become due, as well as to explore additional avenues to increase revenues and reduce or
delay expenditures. Our failure to remain listed on Nasdaq will make it more difficult to raise additional capital. There can be no assurance
that we will be able to raise additional capital on acceptable terms, or at all. Despite our ability to secure capital in the past, there
can be no assurance that additional equity or debt financing will be available to us or that we may be able to secure funding from any
other sources. In the event that we are not able to secure funding, we may be forced to curtail operations, delay or stop ongoing development
activities, cease operations altogether,and/or file for bankruptcy.
Off-Balance
Sheet Arrangements
We
have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition,
changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that
is material to stockholders.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
Not
applicable.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures (as that term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act
of 1934, as amended (the “Exchange Act”)) that are designed to ensure that information required to be disclosed in our reports
under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and
forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal
financial officer, as appropriate, to allow timely decisions regarding required disclosures. In designing disclosure controls and procedures,
our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls
and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood
of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future
conditions. Any controls and procedures, no matter how well designed and operated, can provide only reasonable, not absolute, assurance
of achieving the desired control objectives.
Our
management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness
of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report. Based
upon that evaluation and subject to the foregoing, our principal executive officer and principal financial officer concluded that, as
of the end of the period covered by this Quarterly Report, the design and operation of our disclosure controls and procedures were not effective due to the material
weakness in our internal control over financial reporting.
Management
determined that we had the following material weakness in our internal control over financial reporting as of December 31, 2023:
We
did not perform appropriate analyses related to our internal control over financial reporting in the accounting for whether it is probable
we will collect substantially all the consideration to which we are entitled for revenue services provided, as well as our estimated
credit losses. As of September 30, 2024, such material weakness had not been remediated.
Remediation
Activities
Management’s
remediation activities, which have already commenced and will continue during 2024, include the design of enhanced controls that include
a thorough credit assessment of all new customers, analysis of payment history for existing customers and its impact related to the accounting
for revenues, and additional controls designed to calculate the expected credit loss on the balances when there is an indication that
a customer may not be pay the full receivable amount. These controls are already designed, however, management will need a number of periods
in order to ensure their effectiveness.
Changes
in Internal Control Over Financial Reporting
Except
as set forth above, there have been no changes in our internal control over financial reporting during the quarter ended September 30,
2024 that have materially affected, or that are reasonably likely to materially affect, our internal control over financial reporting.
PART
II – OTHER INFORMATION
Item
1. Legal Proceedings
Information
regarding legal proceedings is available in Note 12 to the condensed consolidated financial statements in this Report.
Except
as described above, we are not involved in any pending material legal proceedings.
ITEM
1A. RISK FACTORS
An
investment in the Company’s Common Stock involves a number of very significant risks. You should carefully consider the risk factors
included in the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2023, as filed with
the SEC on April 15, 2024, in addition to other information contained in our reports and in this quarterly report in evaluating the Company
and its business before purchasing shares of our Common Stock. Except as set forth below, there have been no material changes to our
risk factors contained in our Annual Report on Form 10-K for the year ended December 31, 2023. The Company’s business, operating
results and financial condition could be adversely affected due to any of those risks.
We
may be unsuccessful in raising the capital necessary to address our going concern issues, or if we are successful, it may be on terms
that are highly dilutive to existing stockholders.
Historically,
we funded our operations by raising capital from external sources, including through the sale of common stock and convertible loans.
We are currently facing significant challenges to our ability to raise significant amounts of capital through the sale of common stock,
including the following factors:
● |
in
general, it is difficult for development stage companies to raise capital under current market conditions; |
|
|
● |
the
perception that we may be unable to continue as a going concern may impede our ability to attract further equity investment; and |
|
|
● |
our
common stock was delisted from the Nasdaq Capital Market and our common stock began trading on the OTCQX on October 21, 2024. The
delisting of our common stock from Nasdaq could adversely affect our ability to raise additional capital through the public or private
sale of equity securities. |
Given
these factors, there can be no assurances we will be successful at raising sufficient capital to address our going concern issues. However,
if we are successful, it may be on terms that are very dilutive to existing stockholders. Despite our ability to secure capital in the
past, there can be no assurance that additional equity or debt financing will be available to us or that we may be able to secure funding
from any other sources. In the event that we are not able to secure funding, we may be forced to curtail operations, delay or stop ongoing
development activities, cease operations altogether, and/or file for bankruptcy.
The
delisting of our common stock from Nasdaq could adversely affect our ability to raise additional capital through the public or private
sale of equity securities and the ability of investors to dispose of, or obtain accurate quotations as to the market value of, our common
stock.
Our
common stock was delisted by Nasdaq and our common stock currently trades on the OTCQX market. Our lack of a listing on a national securities
exchange will likely result in it being more difficult for us to raise additional capital through the public or private sale of equity
securities and for investors to dispose of, or obtain accurate quotations as to the market value of, our common stock. In addition, there
can be no assurance that our common stock will be able to maintain its eligibility for trading on the OTCQX or any alternative exchange
or markets.
Unless
our common stock is listed on a national securities exchange, such as the Nasdaq Capital Market, our common stock may also be subject
to the regulations regarding trading in “penny stocks,” which are those securities trading for less than $5.00 per share,
and that are not otherwise exempted from the definition of a penny stock under other exemptions provided for in the applicable regulations.
The following is a list of the general restrictions on the sale of penny stocks:
● |
Before
the sale of penny stock by a broker-dealer to a new purchaser, the broker-dealer must determine whether the purchaser is suitable
to invest in penny stocks. To make that determination, a broker-dealer must obtain, from a prospective investor, information regarding
the purchaser’s financial condition, investment experience, and objectives. Subsequently, the broker-dealer must deliver to
the purchaser a written statement setting forth the basis of the suitability finding and obtain the purchaser’s signature on
such statement. |
● |
A
broker-dealer must obtain from the purchaser an agreement to purchase the securities. This agreement must be obtained for every purchase
until the purchaser becomes an “established customer.” |
|
|
● |
The
Exchange Act requires that before effecting any transaction in any penny stock, a broker-dealer must provide the purchaser with a
“risk disclosure document” that contains, among other things, a description of the penny stock market and how it functions,
and the risks associated with such investment. These disclosure rules are applicable to both purchases and sales by investors. |
|
|
● |
A
dealer that sells penny stock must send to the purchaser, within 10 days after the end of each calendar month, a written account
statement including prescribed information relating to the security. |
These
requirements can severely limit the liquidity of securities in the secondary market because fewer brokers or dealers are likely to be
willing to undertake these compliance activities. If our common stock is not listed on a national securities exchange, the rules and
restrictions regarding penny stock transactions may limit an investor’s ability to sell to a third party and our trading activity
in the secondary market may be reduced.
We
conduct certain of our operations in Israel. Conditions in Israel, including the attack by Hamas on October 7, 2023 and other terrorist
organizations and Israel’s war against them, may affect certain of our operations.
Because
we conduct certain operations in the State of Israel, some of our business and operations may be affected by economic, political, geopolitical
and military conditions in Israel. In October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and
conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks on Israeli population and
industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. Following the
attack, Israel’s security cabinet declared war against Hamas and a military campaign against these terrorist organizations commenced
in parallel to their continued rocket and terror attacks. Moreover, the clash between Israel and Hezbollah in Lebanon, may escalate in
the future into a greater regional conflict. The intensity and duration of Israel’s current war against Hamas is difficult to predict,
as are such war’s economic implications on the Company’s business and operations and on Israel’s economy in general.
Any
hostilities involving Israel, or the interruption or curtailment of trade within Israel or between Israel and its trading partners could
adversely affect certain of our operations and results of operations and could make it more difficult for us to raise capital. The conflict
in Israel could also result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated
to perform their commitments under those agreements pursuant to force majeure provisions in such agreements. There have been travel advisories
imposed relating to travel to Israel, and restriction on travel, or delays and disruptions as related to imports and exports may be imposed
in the future. Additionally, certain members of our management and employees are located and reside in Israel. Shelter-in-place and work-from-home
measures, government-imposed restrictions on movement and travel and other precautions taken to address the ongoing conflict may temporarily
disrupt our management and employees’ ability to effectively perform their daily tasks.
The
Israel Defense Forces (the “IDF”), the national military of Israel, is a conscripted military service, subject to certain
exceptions. Certain of our R&D and finance personnel live in Israel. Certain of our employees are subject to military service in
the IDF and have been called to serve, and additional employees may be called to serve in the future. It is possible that there will
be further military reserve duty call-ups in the future, which may affect our business due to a shortage of skilled labor and loss of
institutional knowledge, and necessary mitigation measures we may take to respond to a decrease in labor availability, such as overtime
and third-party outsourcing, for example, may have unintended negative effects and adversely impact our results of operations, liquidity
or cash flows. Additionally, the absence of employees of our Israeli suppliers and service providers due to their military service in
the current or future wars or other armed conflicts may disrupt their operations, which in turn may adversely affect our ability to deliver
or provide products and services to customers.
The
hostilities with Hamas, Hezbollah and other organizations and countries have included and may include terror, missile and drone attacks.
In the event that any of our facilities, including back-up information technology systems located in Israel, are damaged as a result
of hostile actions, or hostilities otherwise disrupt our ongoing operations, our ability to deliver or provide products and services
in a timely manner to meet our contractual obligations towards customers and vendors could be adversely affected. Our commercial insurance
does not cover losses that may occur as a result of events associated with war and terrorism. Although the Israeli government currently
covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, we cannot assure you that this
government coverage will be maintained or that it will sufficiently cover our potential damages. Any losses or damages incurred by us
could have a material adverse effect on our business. Any armed conflicts or political instability in the region would likely negatively
affect business conditions and could harm our results of operations.
As
of the date of this Quarterly Report, our operations have not been directly negatively affected by the ongoing hostilities in the region.
As a result, as of the date of this Quarterly Report, our ability to deliver or provide products and services to our customers has not
been materially affected. We cannot currently assess how the ongoing hostilities will affect our business conditions and harm our results
of operations in the future, given the factors and risks discussed above.
ITEM
2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS DURING THE QUARTER
On
April 5, 2024, the Company entered into a loan agreement with a lender. In consideration for the loan agreement, the Company agreed to
issue warrants to purchase up to 21,875 shares of Common Stock at an exercise price of $8 which vested upon issuance. These warrants
and the shares of Common Stock underlying such warrants were issued in reliance upon an exemption from registration afforded by Section
4(a)(2) promulgated under the Securities Act of 1933, as amended.
On
April 7, 2024, the Company entered into a loan agreement with a lender. In consideration for the loan agreement, the Company agreed to
issue warrants to purchase up to 15,625 shares of Common Stock at an exercise price of $8 which vested upon issuance. These warrants
and the shares of Common Stock underlying such warrants were issued in reliance upon an exemption from registration afforded by Section
4(a)(2) promulgated under the Securities Act of 1933, as amended.
On
July 14, 2024, the Company entered into a strategic advisor agreement with an individual relating to the provision of strategic advice
and assistance to the Company for a term of 12 months. In consideration for such services, the Company agreed to issue warrants to purchase
up to 20,000 shares of Common Stock at an exercise price of $10.30, which vests one third on July 14, 2024, one third on October 14,
2024, and one third on January 14, 2025. These warrants and the shares of Common Stock underlying such warrants were issued in reliance
upon an exemption from registration afforded by Section 4(a)(2) promulgated under the Securities Act of 1933, as amended.
On
August 15, 2024, the Company entered into a payment deferral agreement with a vendor relating to the deferral of payments to the vendor.
In consideration for such deferral, the Company agreed to issue warrants to purchase up to 42,464 shares of Common Stock at an exercise
price of $10.30, which vested upon issuance. These warrants and the shares of Common Stock underlying such warrants were issued in reliance
upon an exemption from registration afforded by Section 4(a)(2) promulgated under the Securities Act of 1933, as amended.
On
August 21, 2024, the Company entered into a loan agreement with a lender. In consideration for the loan agreement, the Company agreed
to issue warrants to purchase up to 24,272 shares of Common Stock at an exercise price of $10.30 which vested upon issuance. These warrants
and the shares of Common Stock underlying such warrants were issued in reliance upon an exemption from registration afforded by Section
4(a)(2) promulgated under the Securities Act of 1933, as amended.
On
September 5, 2024, the Company entered into a strategic advisor agreement with an individual relating to the provision of strategic advice
and assistance to the Company for a term of 12 months. In consideration for such services, the Company agreed to issue 50,000 shares
of Common Stock. These shares of Common Stock were issued in reliance upon an exemption from registration afforded by Section 4(a)(2)
promulgated under the Securities Act of 1933, as amended.
On
September 6, 2024, the Company entered into a loan agreement with a lender. In consideration for the loan agreement, the Company agreed
to issue warrants to purchase up to 24,272 shares of Common Stock at an exercise price of $10.30 which vested upon issuance. These warrants
and the shares of Common Stock underlying such warrants were issued in reliance upon an exemption from registration afforded by Section
4(a)(2) promulgated under the Securities Act of 1933, as amended.
On
September 9, 2024, the Company entered into a loan agreement with a lender. In consideration for the loan agreement, the Company agreed
to issue warrants to purchase up to 24,272 shares of Common Stock at an exercise price of $10.30 which vested upon issuance. These warrants
and the shares of Common Stock underlying such warrants were issued in reliance upon an exemption from registration afforded by Section
4(a)(2) promulgated under the Securities Act of 1933, as amended.
On
September 10, 2024, the Company entered into a loan agreement with a lender. In consideration for the loan agreement, the Company agreed
to issue warrants to purchase up to 1,942 shares of Common Stock at an exercise price of $10.30 which vested upon issuance. These warrants
and the shares of Common Stock underlying such warrants were issued in reliance upon an exemption from registration afforded by Section
4(a)(2) promulgated under the Securities Act of 1933, as amended.
On
September 17, 2024, the Company entered into a loan agreement with a lender. In consideration for the loan agreement, the Company agreed
to issue warrants to purchase up to 24,272 shares of Common Stock at an exercise price of $10.30 which vested upon issuance. These warrants
and the shares of Common Stock underlying such warrants were issued in reliance upon an exemption from registration afforded by Section
4(a)(2) promulgated under the Securities Act of 1933, as amended.
On
September 21, 2024, the Company entered into a payment deferral agreement with a vendor relating to the deferral of payments to the vendor.
In consideration for such deferral, the Company agreed to issue warrants to purchase up to 3,496 shares of Common Stock at an exercise
price of $10.30, which vested upon issuance. These warrants and the shares of Common Stock underlying such warrants were issued in reliance
upon an exemption from registration afforded by Section 4(a)(2) promulgated under the Securities Act of 1933, as amended.
On
September 30, 2024, the Company entered into a loan agreement with a lender. In consideration for the loan agreement, the Company agreed
to issue warrants to purchase up to 14,563 shares of Common Stock at an exercise price of $10.30 which vested upon issuance. These warrants
and the shares of Common Stock underlying such warrants were issued in reliance upon an exemption from registration afforded by Section
4(a)(2) promulgated under the Securities Act of 1933, as amended.
ITEM
3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4. MINE SAFETY DISCLOSURES
Not
Applicable.
Item
5. Other Information
None.
Item
6. Exhibits
Exhibits
required by Item 601 of Regulation S-K
No. |
|
Description |
3.1 |
|
Certificate of Change of Orgenesis Inc. dated September 20, 2024 (incorporated by reference to exhibit 3.1 to our current report on Form 8-K, filed on September 23, 2024). |
(10) |
|
Material
Contracts |
10.1 |
|
Loan Agreement dated July 3, 2024, by and among Koligo Therapeutics Inc. and Yehuda Nir (incorporated by reference to an exhibit to our current report on Form 8-K, filed on July 8, 2024). |
10.2 |
|
Asset
Purchase Agreement, dated as of July 10, 2024, between Orgenesis Inc. and Broaden Bioscience and Technology Corp. (incorporated by
reference to an exhibit to our current report on Form 8-K, filed on July 12, 2024). |
10.3 |
|
Asset Purchase Agreement, dated as of July 12, 2024, among Orgenesis Inc., Theracell Advanced Biotechnology S.A, Theracell Advanced Biotechnology LTD and IDNA Genomics Public Limited (incorporated by reference to an exhibit to our current report on Form 8-K, filed on July 12, 2024). |
10.4 |
|
Strategic
Partnership Agreement, dated as of August 9, 2024, by and between Orgenesis Inc. and Harley Street Healthcare Group (London) Plc
Ltd. (incorporated by reference to an exhibit to our current report on Form 8-K, filed on August 14, 2024). |
|
|
Amended and Restated Promissory Note, dated as of August 23, 2024, by and between Orgenesis Maryland LLC, Jacob Safier and Orgenesis Inc. (incorporated by reference to an exhibit to our current report on Form 8-K, filed on August 26, 2024). |
(31) |
|
Rule
13a-14(a)/15d-14(a) Certification |
31.1* |
|
Certification
Statement of the Chief Executive Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002 |
31.2* |
|
Certification
Statement of the Chief Financial Officer pursuant to Section 302 of the Sarbanes Oxley Act of 2002 |
(32) |
|
Section
1350 Certification |
32.1* |
|
Certification
Statement of the Chief Executive Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002 |
32.2* |
|
Certification
Statement of the Chief Financial Officer pursuant to Section 906 of the Sarbanes Oxley Act of 2002 |
(101)* |
|
Interactive
Data Files |
101.INS |
|
Inline
XBRL Instance Document |
101.SCH |
|
Inline
XBRL Taxonomy Extension Schema Document |
101.CAL |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF |
|
Inline
XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase
Document |
101.PRE |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase Document |
104 |
|
Cover
Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) |
*
Filed herewith.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
ORGENESIS
INC. |
|
|
|
By: |
|
|
|
/s/
Vered Caplan |
|
Vered
Caplan |
|
President
& Chief Executive Officer |
|
(Principal
Executive Officer) |
|
Date:
November 13, 2024 |
|
|
|
/s/
Victor Miller |
|
Victor
Miller |
|
Chief
Financial Officer, Treasurer and Secretary |
|
(Principal
Financial Officer and Principal Accounting Officer) |
|
Date:
November 13, 2024 |
|
Exhibit
31.1
ORGENESIS
INC.
CERTIFICATION
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Vered Caplan, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 of Orgenesis Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a–15(e) and 15d–15(e)) and internal control over financial reporting (as defined
in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have: |
|
|
|
(a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
(b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
(c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
(d) |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
|
|
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
|
|
(a) |
All
significant deficiencies and material weaknesses in the design or operations of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
(b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
By: |
|
|
|
/s/
Vered Caplan |
|
Vered
Caplan |
|
President
& Chief Executive Officer |
|
(Principal
Executive Officer) |
|
Date:
November 13, 2024 |
|
Exhibit
31.2
ORGENESIS
INC.
CERTIFICATION
PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I,
Victor Miller, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 of Orgenesis Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a–15(e) and 15d–15(e)) and internal control over financial reporting (as defined
in Exchange Act Rules 13a–15(f) and 15d–15(f)) for the registrant and have: |
|
|
|
|
(a) |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
(b) |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
(c) |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
(d) |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
|
|
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
|
|
|
(a) |
All
significant deficiencies and material weaknesses in the design or operations of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
(b) |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
By: |
|
|
|
/s/
Victor Miller |
|
Victor
Miller |
|
Chief
Financial Officer, Treasurer and Secretary |
|
(Principal
Financial Officer and Principal Accounting Officer) |
|
Date:
November 13, 2024 |
|
Exhibit
32.1
ORGENESIS
INC.
CERTIFICATION
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
The
undersigned, Vered Caplan, hereby certifies, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(a) |
The
Quarterly Report on Form 10-Q of Orgenesis Inc. for the quarter ended September 30, 2024 fully complies with the requirements of
Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
(b) |
Information
contained in the Quarterly Report on Form 10-Q fairly presents, in all material respects, the financial condition and results of
operations of Orgenesis Inc. |
By: |
|
|
|
/s/
Vered Caplan |
|
Vered
Caplan |
|
President
& Chief Executive Officer |
|
(Principal
Executive Officer) |
|
Date:
November 13, 2024 |
|
Exhibit
32.2
ORGENESIS
INC.
CERTIFICATION
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
The
undersigned, Victor Miller, hereby certifies, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(a) |
The
Quarterly Report on Form 10-Q of Orgenesis Inc. for the quarter ended September 30, 2024 fully complies with the requirements of
Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
(b) |
Information
contained in the Quarterly Report on Form 10-Q fairly presents, in all material respects, the financial condition and results of
operations of Orgenesis Inc. |
By: |
|
|
|
/s/
Victor Miller |
|
Victor
Miller |
|
Chief
Financial Officer, Treasurer and Secretary |
|
(Principal
Financial Officer and Principal Accounting Officer) |
|
Date:
November 13, 2024 |
|
v3.24.3
Cover - shares
|
9 Months Ended |
|
Sep. 30, 2024 |
Nov. 13, 2024 |
Cover [Abstract] |
|
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Document Type |
10-Q
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Amendment Flag |
false
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Document Quarterly Report |
true
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false
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Document Period End Date |
Sep. 30, 2024
|
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Document Fiscal Period Focus |
Q3
|
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Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-38416
|
|
Entity Registrant Name |
ORGENESIS
INC
|
|
Entity Central Index Key |
0001460602
|
|
Entity Tax Identification Number |
98-0583166
|
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Entity Incorporation, State or Country Code |
NV
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Entity Address, Address Line One |
20271
Goldenrod Lane
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Entity Address, City or Town |
Germantown
|
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Entity Address, State or Province |
MD
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Entity Address, Postal Zip Code |
20876
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City Area Code |
(480)
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Local Phone Number |
659-6404
|
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Title of 12(b) Security |
Common
Stock
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Trading Symbol |
ORGS
|
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Entity Current Reporting Status |
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v3.24.3
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
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
|
Receivable 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
|
CURRENT LIABILITIES: |
|
|
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 payable 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 |
(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
|
Nonrelated Party [Member] |
|
|
CURRENT LIABILITIES: |
|
|
Accounts payable |
11,338
|
6,451
|
Related Party [Member] |
|
|
CURRENT LIABILITIES: |
|
|
Accounts payable |
$ 2,699
|
$ 133
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v3.24.3
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Allowance for credit losses |
$ 14,397
|
$ 0
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
14,583,333
|
14,583,333
|
Common stock, shares issued |
4,799,323
|
3,216,363
|
Common stock, shares outstanding |
4,770,666
|
3,187,706
|
Treasury stock, shares |
28,656
|
28,656
|
X |
- DefinitionAmount of allowance for credit loss on accounts receivable, classified as current.
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v3.24.3
Condensed Consolidated Statements of Loss and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Revenues |
$ 347
|
$ 110
|
$ 734
|
$ 365
|
Cost of revenues |
585
|
139
|
1,615
|
6,093
|
Gross 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 profit 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 |
$ 1.93
|
$ 0.12
|
$ 7.06
|
$ 1.70
|
Diluted |
$ 1.93
|
$ 0.12
|
$ 7.06
|
$ 1.70
|
Weighted average number of shares used in computation of Basic and Diluted loss per share: |
|
|
|
|
Basic |
4,715,229
|
3,002,259
|
3,938,419
|
2,868,078
|
Diluted |
4,715,229
|
3,002,259
|
3,938,419
|
2,868,078
|
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 loss attributed to non-controlling interests |
(146)
|
|
(848)
|
(9,557)
|
Comprehensive loss attributed to Orgenesis Inc. |
$ 9,637
|
$ 3,716
|
$ 28,069
|
$ 48,397
|
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v3.24.3
Condensed Consolidated Statements of Loss and Comprehensive Loss (Unaudited) (Parenthetical) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Credit losses expenses |
$ 0
|
$ 0
|
$ 2,725
|
$ 24,367
|
X |
- References
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v3.24.3
Condensed Consolidated Statements of Changes in Equity (Unaudited) - USD ($) $ in Thousands |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
AOCI Attributable to Parent [Member] |
Treasury Stock, Common [Member] |
Retained Earnings [Member] |
Parent [Member] |
Noncontrolling Interest [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 3
|
|
$ 150,355
|
|
$ (270)
|
$ (1,266)
|
$ (121,261)
|
$ 27,561
|
|
$ 1,510
|
$ 29,071
|
|
Balance, shares at Dec. 31, 2022 |
2,554,455
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
387
|
|
|
|
|
387
|
|
|
387
|
|
Issuance of warrants with respect to loans (see note 7) |
|
|
449
|
|
|
|
|
449
|
|
|
449
|
|
Extinguishment in connection with convertible loan restructuring |
|
|
287
|
|
|
|
|
287
|
|
|
287
|
|
Issuance of shares due to exercise of warrants |
|
[1] |
|
|
|
|
|
|
|
|
|
|
Issuance of shares due to exercise of warrants, shares |
97,368
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss) for the period |
|
|
|
|
(43)
|
|
(48,738)
|
(48,781)
|
|
(150)
|
(48,931)
|
|
Issuance of shares and warrants net of issuance costs |
|
[1] |
4,341
|
|
|
|
|
4,341
|
|
|
4,341
|
|
Issuance of shares and warrants net of issuance costs, shares |
394,739
|
|
|
|
|
|
|
|
|
|
|
|
Deconsolidation of Octomera |
|
|
9,406
|
|
384
|
|
|
9,790
|
|
(1,360)
|
8,430
|
|
Adjustment to redemption value of redeemable non-controlling interest |
|
|
(9,406)
|
|
|
|
|
(9,406)
|
|
|
(9,406)
|
|
Balance at Sep. 30, 2023 |
$ 3
|
|
155,819
|
|
71
|
(1,266)
|
(169,999)
|
(15,372)
|
|
|
(15,372)
|
|
Balance, shares at Sep. 30, 2023 |
3,046,562
|
|
|
|
|
|
|
|
|
|
|
|
Balance at Jun. 30, 2023 |
$ 3
|
|
154,743
|
|
62
|
(1,266)
|
(166,274)
|
(12,732)
|
|
|
(12,732)
|
|
Balance, shares at Jun. 30, 2023 |
2,846,562
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
76
|
|
|
|
|
76
|
|
|
76
|
|
Comprehensive income (loss) for the period |
|
|
|
|
9
|
|
(3,725)
|
(3,716)
|
|
|
(3,716)
|
|
Issuance of shares |
|
[2] |
1,000
|
|
|
|
|
1,000
|
|
|
1,000
|
|
Issuance of shares, shares |
200,000
|
|
|
|
|
|
|
|
|
|
|
|
Balance at Sep. 30, 2023 |
$ 3
|
|
155,819
|
|
71
|
(1,266)
|
(169,999)
|
(15,372)
|
|
|
(15,372)
|
|
Balance, shares at Sep. 30, 2023 |
3,046,562
|
|
|
|
|
|
|
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 3
|
|
156,837
|
|
65
|
(1,266)
|
(176,622)
|
(20,983)
|
|
|
(20,983)
|
|
Balance, shares at Dec. 31, 2023 |
3,187,588
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
304
|
|
|
|
|
304
|
|
|
304
|
|
RSUs vested |
|
[3] |
|
|
|
|
|
|
[3] |
|
|
[3] |
RSUs vested, shares |
9,949
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of options |
|
[3] |
13
|
|
|
|
|
13
|
|
|
13
|
|
Exercise of options, shares |
25,519
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares to service providers |
|
|
1,506
|
|
|
|
|
1,506
|
|
|
1,506
|
|
Issuance of shares to service providers, shares |
116,400
|
|
|
|
|
|
|
|
|
|
|
|
Exchange of convertible loans for equity |
$ 1
|
|
20,310
|
|
|
|
|
20,311
|
|
|
20,311
|
|
Exchange of convertible loans for equity, shares |
1,182,913
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of warrants with respect to loans (see note 7) |
|
|
745
|
|
|
|
|
745
|
|
|
745
|
|
Extinguishment in connection with convertible loan restructuring |
|
|
141
|
|
|
|
|
141
|
|
|
141
|
|
Issuance of shares and warrants |
|
[3] |
2,496
|
|
|
|
|
2,496
|
|
|
2,496
|
|
Issuance of shares and warrants, shares |
242,272
|
|
|
|
|
|
|
|
|
|
|
|
NCI arising from Octomera reconsolidation |
|
|
|
|
|
|
|
|
|
408
|
408
|
|
Transaction with NCI (see note 11b) |
|
|
(408)
|
|
|
|
|
(408)
|
|
408
|
|
|
Issuance of shares due to exercise of warrants |
$ 1
|
|
47
|
|
|
|
|
48
|
|
|
48
|
|
Issuance of shares due to exercise of warrants, shares |
6,026
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss) for the period |
|
|
|
|
(280)
|
|
(27,789)
|
(28,069)
|
|
(848)
|
(28,917)
|
|
Balance at Sep. 30, 2024 |
$ 5
|
|
181,991
|
|
(215)
|
(1,266)
|
(204,411)
|
(23,896)
|
|
(32)
|
(23,928)
|
|
Balance, shares at Sep. 30, 2024 |
4,770,667
|
|
|
|
|
|
|
|
|
|
|
|
Balance at Jun. 30, 2024 |
$ 5
|
|
180,752
|
|
302
|
(1,266)
|
(195,291)
|
(15,498)
|
|
(294)
|
(15,792)
|
|
Balance, shares at Jun. 30, 2024 |
4,692,473
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based compensation |
|
|
89
|
|
|
|
|
89
|
|
|
89
|
|
RSUs vested |
|
[4] |
|
|
|
|
|
|
|
|
|
|
RSUs vested, shares |
1,649
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of options |
|
[4] |
|
[4] |
|
|
|
|
[4] |
|
|
[4] |
Exercise of options, shares |
23,019
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of shares to service providers |
|
[4] |
816
|
|
|
|
|
816
|
|
|
816
|
|
Issuance of shares to service providers, shares |
50,000
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of warrants with respect to loans (see note 7) |
|
|
714
|
|
|
|
|
714
|
|
|
714
|
|
Transaction with NCI (see note 11b) |
|
|
(408)
|
|
|
|
|
(408)
|
|
408
|
|
|
Issuance of shares due to exercise of warrants |
|
[4] |
28
|
|
|
|
|
28
|
|
|
28
|
|
Issuance of shares due to exercise of warrants, shares |
3,526
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income (loss) for the period |
|
|
|
|
(517)
|
|
(9,120)
|
(9,637)
|
|
(146)
|
(9,783)
|
|
Balance at Sep. 30, 2024 |
$ 5
|
|
$ 181,991
|
|
$ (215)
|
$ (1,266)
|
$ (204,411)
|
$ (23,896)
|
|
$ (32)
|
$ (23,928)
|
|
Balance, shares at Sep. 30, 2024 |
4,770,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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v3.24.3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
Net loss |
$ (28,637)
|
$ (58,295)
|
Adjustments required to reconcile net loss to net cash used in operating activities: |
|
|
Stock-based compensation |
2,555
|
387
|
Convertible loans induced conversion expenses |
4,304
|
|
Capital loss, net |
134
|
|
Loss from deconsolidation of OBI and Octomera |
66
|
5,343
|
Share in income of associated companies, net |
|
552
|
Depreciation and amortization expenses |
1,625
|
1,366
|
Credit loss on convertible loan receivable |
|
2,688
|
Credit loss related to OBI |
2,049
|
|
Impairment expenses |
692
|
|
Effect of exchange differences on inter-company balances |
1,672
|
106
|
Net changes in operating leases |
41
|
(82)
|
Change in Contingent consideration |
263
|
|
Interest expenses accrued on loans and convertible loans |
1,366
|
880
|
Loss from extinguishment in connection with convertible loan restructuring |
141
|
283
|
Changes in operating assets and liabilities: |
|
|
Accounts receivable |
9
|
30,079
|
Prepaid expenses and other accounts receivable |
1,341
|
(1,598)
|
Inventory |
34
|
(389)
|
Other assets |
(4)
|
10
|
Change in related parties, net |
2
|
|
Accounts payable |
(1,951)
|
3,925
|
Accrued expenses and other payables |
(846)
|
266
|
Employee and related payables |
168
|
135
|
Deferred taxes, net |
(2)
|
9
|
Net cash used in operating activities |
(14,978)
|
(14,335)
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
Purchase of property, plant and equipment |
(263)
|
(2,096)
|
Investment in Octomera |
|
(543)
|
Cash acquired from acquisition of Octomera |
139
|
|
Impact to cash resulting from deconsolidation of OBI |
(5)
|
|
Impact to cash resulting from deconsolidation of Octomera |
|
(973)
|
Investment in long-term deposits |
202
|
(33)
|
Net cash used in investing activities |
73
|
(3,645)
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
Proceeds from issuance of shares and warrants |
2,556
|
4,341
|
Proceeds from issuance of convertible loans |
75
|
5,660
|
Proceeds from transaction with redeemable non-controlling interest that do not acquire control of a subsidiary |
|
5,000
|
Repayment of convertible loans and convertible bonds |
|
(3,000)
|
Repayment of short and long-term debt |
(251)
|
(33)
|
Proceeds from issuance of loans payable |
4,670
|
425
|
Grant received in respect of third party |
790
|
|
Receipt from Germfree (see note 11a) |
6,720
|
|
Net cash provided by financing activities |
14,560
|
12,393
|
NET CHANGE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
(345)
|
(5,587)
|
EFFECT OF EXCHANGE RATE CHANGES ON CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
(12)
|
7
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF PERIOD |
1,479
|
6,369
|
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF PERIOD |
1,122
|
789
|
SUPPLEMENTAL NON-CASH FINANCING AND INVESTING ACTIVITIES |
|
|
Exchange of convertible loans for equity |
16,007
|
|
Right-of-use assets obtained in exchange for new operation lease liabilities |
405
|
752
|
Increase in accounts payable related to purchase of property, plant and equipment |
|
14
|
Extinguishment in connection with convertible loan restructuring |
|
287
|
CASH PAID DURING THE PERIOD FOR: |
|
|
Interest |
$ 4
|
$ 785
|
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v3.24.3
DESCRIPTION OF BUSINESS
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
DESCRIPTION OF BUSINESS |
NOTE
1 – DESCRIPTION OF BUSINESS
a.
General
Orgenesis
Inc. (the “Company”) is a global biotech company working to unlock the potential of Cell and Gene Therapies (“CGTs”)
in an affordable and accessible format. CGTs can be centered on autologous (using the patient’s own cells) or allogenic (using
master banked donor cells) and are part of a class of medicines referred to as advanced therapy medicinal products (“ATMPs”).
The Company is mostly focused on the development of autologous therapies that can be manufactured under processes and systems that are
developed for each therapy using a closed and automated approach that is validated for compliant production near the patient for treatment
of the patient at the point of care (“POCare”).
As
of the date of this report, the Company operates two segments:
| ● | The
“Octomera” segment which includes the Company’s POCare Services that are
performed in decentralized hubs which provide harmonized and standardized services to customers
(“POCare Centers”). The Company’s subsidiary, Octomera LLC, holds all of
the Octomera segment activities. |
| | |
| ● | The
“Therapies” segment which includes therapy related activities. |
On
January 29, 2024, the Company and Metalmark Capital Partners (“Metalmark” or “MM”) entered into a Unit Purchase
Agreement (the “MM UPA”), pursuant to which the Company acquired all of the preferred units of Octomera LLC (“Octomera”)
previously owned by MM (the “MM Acquisition”), and effective that date, reconsolidated Octomera into its accounts. The Company
currently owns 100% of the equity interests of Octomera. The Company had previously, from June 30, 2023 (“date of deconsolidation”),
deconsolidated Octomera from its consolidated financial statements and had recorded its equity interest in Octomera as an equity method
investment.
These
consolidated financial statements include the accounts of Orgenesis Inc. and its subsidiaries.
On
September 20, 2024, the Company implemented a 1-for-10
reverse stock split (the “Reverse Split”) of its authorized and outstanding shares of Common Stock. All share and per share
amounts in these financial statements have been retroactively adjusted to reflect the reverse split as if it had been effected prior
to the earliest financial statement period included herein. Following the Reverse Split, the number
of authorized shares of common stock that the Company is authorized to issue from time to time is 14,583,333 shares.
The
Company’s common stock, par value $0.0001 per share (the “Common Stock”), is traded on the OTCQX under the symbol “ORGS.”
On September 27, 2023, the Company received a notice from the Listing Qualifications Staff (“Staff”) of The Nasdaq Stock
Market LLC (“Nasdaq”) stating that the bid price of the Common Stock had closed at less than $1.00 per share over the previous
30 consecutive business days, and, as a result, did not comply with Listing Rule 5550(a)(2) (the “Bid Price Rule”). On April
17, 2024, the Company received a notice (the “Notice”) from the Staff in which it determined that in accordance with Listing
Rule 5810(c)(2)(A), the Staff stated that it could not accept a plan to regain compliance and the Staff stated that the Company’s
securities would be delisted from The Nasdaq Capital Market unless the Company timely requested a hearing before a Nasdaq Hearings Panel
(the “Panel”) to address the deficiencies and present a plan to regain compliance. As permitted by the Notice, the Company
timely requested a hearing before the Panel, which request stayed any further delisting action by the Staff pending the ultimate outcome
of the hearing and the expiration of any extension that may be granted by the Panel. On June 6, 2024, the Company met with the Panel
regarding the Company’s potential delisting from The Nasdaq Stock Market as a result of its violation of the Bid Price Rule and
non-compliance with the equity requirement in Listing Rule 5550(b)(1) (the “Equity Rule”) or any of the alternative requirements
in Listing Rule 5550(b). On June 8, 2024, the Company received the Panel’s decision which granted the Company until October 14,
2024 to regain compliance with the Bid Price and Equity Rules. On October 17, 2024, Nasdaq notified the Company that the Panel had determined
to delist the Company’s Common Stock and that trading of the Company’s Common Stock will be suspended at the open of trading
on October 21, 2024. In connection with the Nasdaq delisting notice, Nasdaq will complete the delisting by filing a Form 25 Notification
of Delisting with the U.S. Securities and Exchange Commission (the “SEC”) after applicable appeal periods have lapsed. The
Company’s Common Stock began trading under “ORGS” on the OTCQX with the open of the markets on October 21, 2024.
As
used in this report and unless otherwise indicated, the term “Company” refers to Orgenesis Inc. and its Subsidiaries. Unless
otherwise specified, all amounts are expressed in United States Dollars.
b.
Liquidity
Through
September 30, 2024, the Company had an accumulated deficit of $204,411 and for the nine months ended September 30, 2024 incurred negative
operating cashflows of $14,978. The Company’s activities have been funded by generating revenue, through offerings of its securities,
and through proceeds from loans. There is no assurance that the Company’s business will generate sustainable positive cash flows
to fund its activities.
The
Company will need to use mitigating actions such as seeking additional financing, refinancing, or amending the terms of existing loans,
or postponing expenses that are not based on firm commitments. In order to fund its operations until such time that the Company can generate
sustainable positive cash flows, the Company will need to raise additional funds. For the nine months ended September 30, 2024 and as
of the date of this report, the Company has assessed its financial condition and concluded that based on current and projected cash resources
and commitments, as well as other factors mentioned above, there is substantial doubt about its ability to continue as a going concern.
The Company is planning to raise additional capital to continue its operations and to repay its outstanding loans when they become due,
as well as to explore additional avenues to increase revenues and reduce or delay expenditures. In May 2024, the Company entered into
debt exchange agreements with three convertible debt holders pursuant to which a total of $16,007 of outstanding principal and accrued
interest were exchanged for the right to receive an aggregate of 1,577,694 shares of Common Stock. The Company may also exchange some
of its other outstanding loans and accounts payable for securities of the Company. There can be no assurance that the Company will be
able to raise additional capital on acceptable terms, or at all, or be able to exchange its outstanding loans and accounts payable for
securities of the Company.
The
Company’s Common Stock was delisted from the Nasdaq Capital Market and now trades on the OTCQX. Such delisting and trading on the
OTCQX may make it more difficult to raise additional capital.
The
estimation and execution uncertainty regarding the Company’s future cash flows and management’s judgments and assumptions
in estimating these cash flows is a significant estimate. Those assumptions include reasonableness of the forecasted revenue, operating
expenses, and uses and sources of cash.
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v3.24.3
BASIS OF PRESENTATION
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
BASIS OF PRESENTATION |
NOTE
2 - BASIS OF PRESENTATION
a.
Basis of presentation
The
accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial
statements. In the opinion of management, the financial statements reflect all normal and recurring adjustments necessary to fairly state
the financial position and results of operations of the Company. The information included in this Quarterly Report on Form 10-Q should
be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report
on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (“SEC”) on April
15, 2024. The year-end balance sheet data was derived from the audited consolidated financial statements as of December 31, 2023, but
not all disclosures required by generally accepted accounting principles in the United States (“U.S. GAAP”) are included
in this Quarterly Report on Form 10-Q.
b.
Significant accounting policies
The
accounting policies adopted are consistent with those of the previous financial year except as described below:
Use
of Estimates in the Preparation of Financial Statements
The
preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires us to make estimates, judgments
and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of
contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies. The Company
bases its estimates on historical experience and on various other assumptions that it believes are reasonable, the results of which form
the basis for making judgments about the carrying values of assets, liabilities and equity, the amount of revenues and expenses, determination
of loss on deconsolidation, valuation of investments, purchase price allocations, goodwill impairment, and assessment of credit losses
and purchase price allocation including contingent consideration. Actual results could differ from those estimates.
Recently
issued accounting pronouncements, not yet adopted
Improvements
to Public Business Entity’s Expenses Disclosures
In
November 2024, the FASB issued ASU No. 2024-03 Income Statement—Reporting Comprehensive Income—Expense Disaggregation
Disclosures (Subtopic 220-40). The ASU improves the disclosures about a public business entity’s expenses and provides more detailed
information about the types of expenses in commonly presented expense captions. The amendments require that at each interim and annual
reporting period an entity will, inter alia, disclose amounts of purchases of inventory, employee compensation, depreciation and amortization
included in each relevant expense caption (such as cost of sales, SG&A and research and development). The ASU is effective for fiscal
years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption
is permitted. The Company is currently evaluating this ASU to determine its impact on the Company’s disclosures.
Improvements
to Reportable Segments Disclosures
In
November 2023, the FASB issued ASU 2023-07 “Segment Reporting–Improvements to Reportable Segments Disclosures (Topic 280)”
to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The
amendments in this ASU (1) require that a public entity disclose, on an annual and interim basis, significant segment expenses that are
regularly provided to the chief operating decision maker (“CODM”) and included within each reported measure of segment profit
or loss; (2) require that a public entity disclose, on an annual and interim basis, an amount for other segment items by reportable segment
and a description of its composition; (3) require that a public entity provide all annual disclosures about a reportable segment’s
profit or loss and assets currently required by Topic 280 in interim periods; (4) clarify that if the CODM uses more than one measure
of a segment’s profit or loss in assessing segment performance and deciding how to allocate resources, a public entity may report
one or more of those additional measures; and (5) require that a public entity disclose the title and position of the CODM and an explanation
of how the CODM uses the reported measure or measures of segment profit or loss in assessing segment performance and deciding how to
allocate resources. The amendments in this ASU are effective for fiscal years beginning after December 15, 2023, and interim periods
within fiscal years beginning after December 15, 2024, and should be applied retrospectively to all periods presented. Early adoption
is permitted. The Company is currently evaluating the impact of the adoption of these amendments on its consolidated financial statements.
Improvements
to Income Tax Disclosures
In
December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740)–Improvements to Income Tax Disclosures” to enhance
the transparency and decision usefulness of income tax disclosures, primarily related to the rate reconciliation and income taxes paid
information. The amendments in this ASU require that public entities, on an annual basis, disclose specific categories in the rate reconciliation
and provide additional information for reconciling items that meet a quantitative threshold. This ASU also requires that all entities
disclose, on an annual basis, (1) the amount of income taxes paid disaggregated by federal, state, and foreign taxes, (2) the amount
of income taxes paid disaggregated by individual jurisdictions in which income taxes paid is equal to or greater than five percent of
total income taxes paid, (3) income or loss from continuing operations before income tax expense or benefit disaggregated between domestic
and foreign, and (4) income tax expense or benefit from continuing operations disaggregated by federal, state, and foreign. The amendments
in this ASU are effective for annual periods beginning after December 15, 2024, and should be applied on a prospective basis with the
option to apply retrospectively. Early adoption is permitted for annual financial statements that have not yet been issued or made available
for issuance. The Company is currently evaluating the impact of the adoption of these amendments on its consolidated financial statements.
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v3.24.3
SEGMENT INFORMATION
|
9 Months Ended |
Sep. 30, 2024 |
Segment Reporting [Abstract] |
|
SEGMENT INFORMATION |
NOTE
3 – SEGMENT INFORMATION
Segment
data for the nine months ended September 30, 2024 is as follows:
SCHEDULE OF SEGMENT REPORTING
| |
Octomera | | |
Therapies | | |
Eliminations | | |
Consolidated | |
| |
(in
thousands) | |
Revenues | |
$ | 322 | | |
$ | 435 | | |
$ | (23 | ) | |
$ | 734 | |
Cost of revenues* | |
| (1,292 | ) | |
| (521 | ) | |
| 710 | | |
| (1,103 | ) |
Gross profit | |
| (970 | ) | |
| (86 | ) | |
| 687 | | |
| (369 | ) |
Cost of development services and research
and development expenses* | |
| (4,542 | ) | |
| (4,079 | ) | |
| 699 | | |
| (7,922 | ) |
Operating expenses* | |
| (1,226 | ) | |
| (9,012 | ) | |
| (728 | ) | |
| (10,966 | ) |
Impairment expenses ** | |
| - | | |
| (692 | ) | |
| - | | |
| (692 | ) |
Loss from deconsolidation | |
| - | | |
| - | | |
| (66 | ) | |
| (66 | ) |
Other income | |
| (126 | ) | |
| 12 | | |
| - | | |
| (114 | ) |
Depreciation and amortization | |
| (1,171 | ) | |
| (581 | ) | |
| 127 | | |
| (1,625 | ) |
Loss from extinguishment in connection with
convertible loan | |
| - | | |
| (141 | ) | |
| - | | |
| (141 | ) |
Credit losses on convertible loan receivable | |
| | | |
| | | |
| | | |
| | |
Financial income (expenses), net | |
| (756 | ) | |
| (1,752 | ) | |
| 123 | | |
| (2,385 | ) |
Convertible loans induced
conversion expenses | |
| - | | |
| (4,304 | ) | |
| - | | |
| (4,304 | ) |
Share in net income of associated companies | |
| | | |
| | | |
| | | |
| | |
* | Excluding Depreciation,
amortization expenses |
** | Relates to impairment expenses on certain property, plant and equipment. |
Segment
data for the nine months ended September 30, 2023 is as follows:
| |
Octomera | | |
Therapies | | |
Eliminations | | |
Consolidated | |
| |
(in
thousands) | |
Revenues | |
$ | 44 | | |
$ | 350 | | |
$ | (29 | ) | |
$ | 365 | |
Cost of revenues* | |
| (6,959 | ) | |
| (531 | ) | |
| 1,874 | | |
| (5,616 | ) |
Gross profit | |
| (6,915 | ) | |
| (181 | ) | |
| 1,845 | | |
| (5,251 | ) |
Cost of development services and research
and development expenses* | |
| (6,828 | ) | |
| (2,830 | ) | |
| 2,327 | | |
| (7,331 | ) |
Operating expenses* | |
| (31,921 | ) | |
| (4,962 | ) | |
| 3,930 | | |
| (32,953 | ) |
Loss from deconsolidation of Octomera | |
| - | | |
| - | | |
| (5,343 | ) | |
| (5,343 | ) |
Other income, net | |
| 2 | | |
| 2 | | |
| | | |
| 4 | |
Depreciation and amortization | |
| (1,294 | ) | |
| (589 | ) | |
| 517 | | |
| (1,366 | ) |
Loss from extinguishment in connection with
convertible loan | |
| - | | |
| (283 | ) | |
| - | | |
| (283 | ) |
Credit losses on convertible loan receivable | |
| - | | |
| (2,688 | ) | |
| - | | |
| (2,688 | ) |
Financial (expenses) income, net | |
| (587 | ) | |
| (1,425 | ) | |
| 94 | | |
| (1,918 | ) |
Share in net income of
associated companies | |
| - | | |
| (10 | ) | |
| (542 | ) | |
| (552 | ) |
* | Excluding Depreciation,
amortization expenses |
Segment
data for the three months ended September 30, 2024 is as follows:
| |
Octomera | | |
Therapies | | |
Eliminations | | |
Consolidated | |
| |
(in thousands) | |
Revenues | |
$ | 272 | | |
$ | 75 | | |
$ | - | | |
$ | 347 | |
Cost of revenues* | |
| (245 | ) | |
| (192 | ) | |
| - | | |
| (437 | ) |
Gross profit | |
| 27 | | |
| (117 | ) | |
| - | | |
| (90 | ) |
Cost of development services and research and development expenses* | |
| (1,291 | ) | |
| (3,048 | ) | |
| 2 | | |
| (4,337 | ) |
Operating expenses* | |
| (680 | ) | |
| (1,975 | ) | |
| (82 | ) | |
| (2,737 | ) |
Impairment expenses** | |
| - | | |
| (692 | ) | |
| - | | |
| (692 | ) |
Other income | |
| (126 | ) | |
| 4 | | |
| - | | |
| (122 | ) |
Depreciation and amortization | |
| (301 | ) | |
| (194 | ) | |
| (43 | ) | |
| (538 | ) |
Financial expenses, net | |
| (202 | ) | |
| (515 | ) | |
| (1 | ) | |
| (718 | ) |
* | Excluding Depreciation,
amortization expenses |
** | Relates to impairment expenses on certain property, plant and equipment. |
Segment
data for the three months ended September 30, 2023 is as follows:
| |
Octomera | | |
Therapies | | |
Eliminations | | |
Consolidated | |
| |
(in
thousands) | |
Revenues | |
$ | 29 | | |
$ | 110 | | |
$ | (29 | ) | |
$ | 110 | |
Cost of revenues* | |
| (1,875 | ) | |
| (133 | ) | |
| 1,874 | | |
| (134 | ) |
Gross profit | |
| (1,846 | ) | |
| (23 | ) | |
| 1,845 | | |
| (24 | ) |
Cost of development services and research
and development expenses* | |
| (2,327 | ) | |
| (779 | ) | |
| 2,327 | | |
| (779 | ) |
Operating expenses* | |
| (3,931 | ) | |
| (1,240 | ) | |
| 3,930 | | |
| (1,241 | ) |
Other income | |
| - | | |
| 2 | | |
| - | | |
| 2 | |
Depreciation and amortization | |
| (515 | ) | |
| (193 | ) | |
| 517 | | |
| (191 | ) |
Financial (expenses) income, net | |
| (92 | ) | |
| (546 | ) | |
| 93 | | |
| (545 | ) |
Share in net income of
associated companies | |
| - | | |
| (11 | ) | |
| (542 | ) | |
| (553 | ) |
* | Excluding Depreciation,
amortization expenses |
|
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v3.24.3
RECONSOLIDATION OF OCTOMERA LLC
|
9 Months Ended |
Sep. 30, 2024 |
Reconsolidation Of Octomera Llc |
|
RECONSOLIDATION OF OCTOMERA LLC |
NOTE
4 – RECONSOLIDATION OF OCTOMERA LLC
Pursuant
to the MM UPA signed on January 29, 2024, the Company and MM agreed to the following:
| ● | Royalty
Payments: If Octomera and its subsidiaries generate Net Revenue during the three-year period
2025-2027, then the Company will pay 5% of Net Revenues to MM pursuant to the MM UPA. |
| | |
| ● | Milestone
Payments: If the Company sells Octomera within ten years from the date of the Closing at
a price that is more than $40 million excluding consideration for certain Excluded Assets
as per the UPA, the Company shall pay MM 5% of the net proceeds. |
| 2. | MM’s
designated members of the Board of Managers of Octomera resigned and the Company amended
the Second Amended and Restated Limited Liability Company Agreement of Octomera (the “Octomera
LLC Agreement”) to be a single member agreement reflecting the transactions consummated
under the UPA, such that MM no longer (i) is a member of Octomera or a party to the Octomera
LLC Agreement, or (ii) has a right to appoint members of the board of managers of Octomera. |
| | |
| 3. | 10
secured promissory notes between Orgenesis Maryland LLC and MM, reflecting an aggregate outstanding
principal amount of $2,600 (the “Notes”), were amended to, among other things,
extend the maturity thereof to January 29, 2034 and to terminate the security interest granted
by Orgenesis Maryland LLC in favor of MM that secured the obligations under the Notes. |
Fair
Value of Consideration Transferred
Accounting
guidance provides that the allocation of the purchase price may be adjusted for up to one year from the date of the acquisition to the
extent that additional information is obtained about the facts and circumstances that existed as of the acquisition date. The primary
area of the purchase price allocation that is not yet finalized is related to intangible assets, property, plant and equipment, and certain
other assets and tax matters and the related impact on goodwill.
In
evaluating the fair value of the Octomera Equity Investment under the income approach, the Company used a discounted cash flow model
of the business, adjusted to the Company’s share in the investment. Key assumptions used to determine the estimated fair value
included: (a) internal cash flows forecasts for 5 years following the assessment date, including expected revenue growth, costs to produce,
operating profit margins and estimated capital needs; (b) an estimated terminal value using a terminal year long-term future growth determined
based on the growth prospects of the reporting units; and (c) a discount rate which reflects the weighted average cost of capital adjusted
for the relevant risk associated with the Company’s reporting unit operations and the uncertainty inherent in the Company’s
internally developed forecasts. The allocation of the purchase price to the net assets acquired and liabilities assumed resulted in the
recognition of other intangible assets, net, which comprised of technology. The useful life of the technology for amortization purposes
was determined by considering the period of expected cash flows generated by the assets used to measure the fair value of the intangible
assets, adjusted as appropriate for the entity-specific factors including legal, regulatory, contractual, competitive, economic, or other
factors that may limit the useful life of intangible assets.
The
following table summarizes the allocation of purchase price to the fair values of the assets acquired and liabilities assumed as of the
Transaction date:
SCHEDULE OF PURCHASE PRICE TO THE FAIR VALUES OF THE ASSETS ACQUIRED AND LIABILITIES ASSUMED
| |
(in
thousands) | |
Total Contingent
consideration to MM for royalty and milestone payments | |
$ | 4,643 | |
| |
| | |
Total assets acquired: | |
| | |
Cash and cash equivalents | |
$ | 139 | |
Property, plants and equipment,
net | |
| 17,852 | |
Other
Assets | |
| 3,478 | |
Total
assets | |
$ | 21,469 | |
| |
| | |
Total liabilities assumed: | |
| | |
Total current liabilities | |
$ | (12,518 | ) |
Total
long-term liabilities | |
| (5,628 | ) |
Total
liabilities | |
$ | (18,146 | ) |
| |
| | |
Know
how Technology | |
| 1,728 | |
| |
| | |
Total
Net Assets | |
$ | 5,051 | |
Fair-Value
of Non-controlling interests | |
| (408 | ) |
Total
liability to MM | |
$ | 4,643 | |
The
allocation of the purchase price to the net assets acquired and liabilities assumed resulted in the recognition of an intangible asset
know-how of $1,728 and a liability to MM in the amount of $4,643. The know-how has a useful life of 10 years. The useful life of the
intangible asset for amortization purposes was determined considering the period of expected cash flows generated by the assets used
to measure the fair value of the intangible asset adjusted as appropriate for the entity-specific factors, including legal, regulatory,
contractual, competitive, economic or other factors that may limit the useful life of intangible assets.
Key
inputs for the fair values valuation are summarized below.
SCHEDULE OF
KEY INPUTS FOR THE FAIR VALUES VALUATION
Key Valuation
Inputs | |
Jan
29, 2024 | |
Discount rate | |
| 40 | % |
Risk-free interest rate | |
| 4.4 | % |
Average 5 years revenue growth | |
| 50 | % |
Measurement input | |
| 50 | % |
The
Company incurred transaction costs of approximately $50 and $0 during the nine and three months ended September 30, 2024 respectively,
which were included in general and administrative expenses in the condensed consolidated statements of operations.
The
revenues and net loss of Octomera from January 1, 2024 until the reconsolidation date were $23 and $1,244 respectively.
Fair
value assumptions used in accounting for contingent consideration
On
January 29, 2024, in connection with the PPA study of Octomera LLC, the Company recognized a contingent consideration to pay MM based
on two components:
1. Royalties based on revenues in 2025, 2026 and 2027, and;
2. An earnout amount, which is dependent on a future triggering event being either an IPO or exit.
The
estimated fair value of the contingent consideration is based on management’s assessment of whether, and at what level, the financial
metrics will be achieved, and the present value factors associated with the timing of the payments. This fair value measurement is based
on significant unobservable inputs in the market and thus represents a Level 3 fair value measurement and used the Monte Carlo pricing
model to calculate the fair value, which was $4,643
as of January 29, 2024. As of September 30, 2024,
the fair value was $4,906.
Changes in the fair value of contingent consideration are recorded in operating expenses. The total revaluation expense for the period
ended September 30, 2024 was $ 263.
Key
inputs for the simulation are summarized below.
SCHEDULE
OF KEY INPUTS
Key Valuation
Inputs | |
Jan
29, 2024 | | |
September
30, 2024 | |
Standard Deviation | |
| 13.5 | % | |
| 13.6 | % |
Risk-free interest rate | |
| 4.4 | % | |
| 4.2 | % |
Possible trigger event examination | |
| Year
10 | | |
| Year
9.5 | |
Average 5 years revenue growth | |
| 50 | % | |
| 50 | % |
Trigger events | |
| 30 | % | |
| 30 | % |
EV/EBIT Multiple | |
| 11.1 | | |
| 11.1 | |
* | Based on a Monte
Carlo simulation analysis of 30,000 iterations |
Deconsolidation
of Orgenesis Biotech Israel Limited (“OBI”)
On
February 14, 2024, following a claim for payment by employees of OBI, a fully owned subsidiary of Octomera of past salaries due, the
district court in Haifa, Israel appointed a trustee to run the affairs of OBI. As a result of this appointment, effective February 14,
2024, the Company no longer controls OBI and has ceased to consolidate the results of OBI into its consolidated results. The Company
recognized a loss as a result of the deconsolidation of $66. The Company does not currently believe that rehabilitation is possible and
purchased certain OBI equipment.
The
Company recorded $2,699 being what it owes to OBI under Accounts payable related Parties on the balance sheet of September 30, 2024.
The
following table summarizes the deconsolidated assets and liabilities as of February 14, 2024:
SCHEDULE
OF DECONSOLIDATE ASSETS AND LIABILITIES
| |
| |
Total assets acquired: | |
| | |
Cash and cash
equivalents | |
$ | 4 | |
Property, plants and equipment,
net | |
| 2,884 | |
Other
Assets | |
| 1,422 | |
Total
assets | |
$ | 4,310 | |
| |
| | |
Total
liabilities assumed: | |
$ | 4,244 | |
Total
Net Assets deconsolidated | |
$ | 66 | |
Loss
from deconsolidation of OBI | |
$ | 66 | |
|
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v3.24.3
EQUITY
|
9 Months Ended |
Sep. 30, 2024 |
Equity [Abstract] |
|
EQUITY |
NOTE
5 – EQUITY
Private
Placement Offering
On
March 3, 2024, the Company entered into a Securities Purchase Agreement with certain accredited investors, pursuant to which the Company
agreed to issue and sell, in a private placement, 227,272 shares of Common Stock at a purchase price of $10.3 per share, Warrants to
purchase up to 227,272 shares of Common Stock at an exercise price of $15.0 per share, and further Warrants to purchase up to 227,272
shares of Common Stock at an exercise price of $20.0 per share, all such Warrants exercisable immediately and expiring five years from
their date of issuance. The Company received gross proceeds of approximately $2.3 million before deducting related offering expenses.
The Offering closed on March 5, 2024.
On
May 10, 2024, the Company entered into a Securities Purchase Agreement with certain accredited investors, pursuant to which the Company
agreed to issue and sell, in a private placement, 15,000 shares of the Company’s Common Stock at a purchase price of $10.3 per
share, Warrants to purchase up to 15,000 shares of Common Stock at an exercise price of $15.0 per share, and further Warrants to purchase
up to 15,000 shares of Common Stock at an exercise price of $20.0 per share, all such Warrants exercisable immediately and expiring five
years from their date of issuance. The Company received gross proceeds of approximately $154 before deducting related offering expenses.
The Offering closed on May 10, 2024.
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v3.24.3
CONVERTIBLE LOANS
|
9 Months Ended |
Sep. 30, 2024 |
Debt Disclosure [Abstract] |
|
CONVERTIBLE LOANS |
NOTE
6 – CONVERTIBLE LOANS
The
table below summarizes the Company’s outstanding convertible loans as of September 30, 2024.
SCHEDULE OF LONG TERM CONVERTIBLE NOTES
Principal Amount | | |
Issuance Date | | |
Current Interest Rate | | |
Current Maturity | | |
Current Conversion Price of loan into equity | |
at Issuance | | |
(Year) | | |
% | | |
(Year) | | |
$ | |
$ | 100 | | |
| 2019 | | |
| 8 | % | |
| 2024 | | |
| 10.3 | |
| 100 | | |
| 2020 | | |
| 8 | % | |
| 2024 | | |
| 10.3 | |
| 1,150 | | |
| 2022 | | |
| 6 | % | |
| *2023 | | |
| 45.0 | |
| 5,000 | | |
| 2023 | | |
| 8 | % | |
| 2026 | | |
| 24.6 | |
$ | 6,350 | | |
| | | |
| | | |
| | | |
| | |
|
* |
Was
not repaid by September 30, 2024. |
The
table below summarizes the Company’s outstanding convertible loans as of December 31, 2023.
Principal | | |
Issuance Date | | |
Current Interest Rate | | |
Current Maturity | | |
Current Conversion Price of loan into equity | | |
| |
Amount | | |
(Year) | | |
% | | |
(Year) | | |
$ | | |
Note | |
Convertible Loans Outstanding as of December 31, 2023 | | |
| |
$ | 750 | | |
| 2018 | | |
| 10 | % | |
| 2026 | | |
| 25.0 | | |
| | |
| 1,500 | | |
| 2019 | | |
| 10 | % | |
| 2026 | | |
| 25.0 | | |
| | |
| 100 | | |
| 2019 | | |
| 8 | % | |
| 2024 | | |
| 70.0 | | |
| | |
| 5,000 | | |
| 2019 | | |
| 10 | % | |
| 2026 | | |
| 25.0 | | |
| | |
| 100 | | |
| 2020 | | |
| 8 | % | |
| 2024 | | |
| 70.0 | | |
| | |
| 5,000 | | |
| 2022 | | |
| 10 | % | |
| 2026 | | |
| 25.0 | | |
| | |
| 1,150 | | |
| 2022 | | |
| 6 | % | |
| **2023 | | |
| 45.0 | | |
| | |
| 5,000 | | |
| 2023 | | |
| 8 | % | |
| 2026 | | |
| 24.6 | | |
| | |
| 735 | | |
| 2023 | | |
| 8 | % | |
| 2024 | | |
| 08.5 | | |
| | |
$ | 19,335 | | |
| | | |
| | | |
| | | |
| | | |
| | |
|
** |
Was
not yet paid by December 31, 2023. |
Debt
Exchange Agreements
On
May 21, 2024, the Company entered into debt exchange agreements with three convertible debt holders pursuant to which a total of $16,007
of outstanding principal and accrued interest was exchanged for the right to receive an aggregate of 1,577,695 shares of Common Stock
of the Company. A total of 1,182,919 shares of Common Stock have been issued pursuant to the debt exchange agreements as of September
30, 2024. The Company reduced the exchange price from $25.0 to $10.3 per share for a total of $14,784 of outstanding principal. As a
result, the Company recorded an induced conversion expense equal to the fair value of the incremental consideration, amounting to $4,304.
Additional
notes related to changes in convertible loans terms that occurred in 2024
In
January 2024, the Company and lender agreed to extend the maturity date of the loan amount to December 31, 2026. In consideration for
such extension, the Company issued to the lender warrants to purchase 84,000 shares of Common Stock at an exercise price of $8.5 per
share. Based on its analysis, the Company concluded that this change in terms should be accounted for as an extinguishment. The loan
amount was included in the debt exchange agreement.
|
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.24.3
LOANS
|
9 Months Ended |
Sep. 30, 2024 |
Loans |
|
LOANS |
NOTE
7 –LOANS
The
table below summarizes the Company’s outstanding long-term loans as of September 30, 2024 and December 31, 2023, respectively:
SCHEDULE OF LONG TERM LOANS
Principal Amount | | |
Interest Rate | | |
Year of Maturity | | |
September 30, 2024 | | |
December31, 2023 | |
(in thousands) | | |
% | | |
| | |
(in thousands) | |
$ | 2,600 | | |
| 10 | | |
| 2034 | | |
$ | 2,828 | | |
$ | - | |
See
note 4.
The
table below summarizes the Company’s outstanding short-term loans as of September 30, 2024 and December 31, 2023, respectively:
SCHEDULE OF SHORT TERM LOANS
Currency | |
Interest Rate | | |
September 30, 2024 | | |
December 31, 2023 | |
| |
% | | |
(in thousands) | |
USD | |
| 8 | | |
$ | 287 | | |
$ | 258 | |
USD | |
| 10 | | |
| 4,603 | | |
| 61 | |
USD | |
| (*)8 | | |
| - | | |
| (**)331 | |
Euro | |
| 8 | | |
| 15 | | |
| - | |
| |
| | | |
$ | 4,905 | | |
$ | 650 | |
(*) | | Weighted average
interest. |
(**) | | The terms of the
loan were amended on January 1, 2024. Under the new terms, the loan became convertible into shares of Common Stock and the lender agreed
to extend the maturity date to December 31, 2024. In consideration for such extension, the Company issued to the lender warrants to purchase
36,000 shares of the Company’s Common Stock at a price of $8.5 per share and granted lender the right to convert any part of the
outstanding balance of the loan into Common Stock of the Company at the conversion rate of $8.5 per share. Based on its analysis, the
Company concluded that this change in terms should be accounted for as a modification. This loan was converted as per the debt exchange
agreement. See note 6. |
During
October 2024, the Company entered into short term loan agreements with certain parties for a total of $790. The loans bear 10% annual
interest, and the loan holders were issued warrants to purchase a total of 767,089 shares of Common Stock of the Company at a price of
$1.03 per share. In addition, during October 2024, the Company agreed with certain short term loan holders to extend the maturity date
of loans in the amount of $2,300. The Company reduced the warrant exercise price for 526,187 warrants held by such loan holders to $1.03.
The
table below summarizes the Company’s warrants granted to loan holders for the period ended September 30, 2024.
SCHEDULE
OF WARRANTS GRANTED
Date of issuance | |
Reason for issuance | |
Number of warrants | | |
Weighted Average Exercise price | | |
Warrant vesting (subject to continued service provided to Company) | |
Expiration date |
April 07, 2024 | |
Loan Agreement | |
| 15,625 | | |
$ | 8 | | |
Immediate | |
October 06, 2024 |
April 05, 2024 | |
Loan Agreement | |
| 21,875 | | |
$ | 8 | | |
Immediate | |
October 04, 2024 |
August 21, 2024 | |
Loan Agreement | |
| 24,272 | | |
$ | 10.3 | | |
Immediate | |
August 20, 2029 |
August 21, 2024 | |
Loan Agreement | |
| 97,088 | | |
$ | 10.3 | | |
Immediate | |
August 20, 2029 |
September 06, 2024 | |
Loan Agreement | |
| 24,272 | | |
$ | 10.3 | | |
Immediate | |
September 05, 2025 |
September 10, 2024 | |
Loan Agreement | |
| 1,942 | | |
$ | 10.3 | | |
Immediate | |
September 09, 2025 |
September 09, 2024 | |
Loan Agreement | |
| 24,272 | | |
$ | 10.3 | | |
Immediate | |
September 08, 2029 |
September 17, 2024 | |
Loan Agreement | |
| 24,272 | | |
$ | 10.3 | | |
Immediate | |
September 16, 2029 |
September 30, 2024 | |
Loan Agreement | |
| 14,563 | | |
$ | 10.3 | | |
Immediate | |
September 29, 2025 |
Total | |
| |
| 248,181 | | |
$ | 10.0 | | |
| |
|
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v3.24.3
STOCK-BASED COMPENSATION
|
9 Months Ended |
Sep. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
STOCK-BASED COMPENSATION |
NOTE
8 – STOCK-BASED COMPENSATION
|
a. |
Options
Granted to Employees |
The
table below summarizes the terms of options for the purchase of shares in the Company granted to employees during the period from January
1, 2024 to September 30, 2024:
SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES
| |
No.
of Options Granted | | |
Exercise
Price | | |
Vesting Period | |
Fair Value at Grant (in
thousands) | | |
Expiration Period |
Employees | |
| 126,912 | | |
| $5.0-$10.3 | | |
41,100 quarterly over a period of two years, 20,000 quarterly over a period of four years, 1,250 annually over a period of three years and 64,563 immediate | |
$ | 655 | | |
10 years |
The
fair valuation of these option grants is based on the following assumptions:
SCHEDULE
OF STOCK OPTIONS ACTIVITY
| |
During the Period from January 1, 2024 to September 30, 2024 | |
Value of one common share | |
| $4.9-$10.3 | |
Dividend yield | |
| 0 | % |
Expected stock price volatility | |
| 79%-110 | % |
Risk free interest rate | |
| 3.86%-4.49 | % |
Expected term (years) | |
| 2.50-6.06 | |
|
b. |
Restricted
Stock Units (“RSUs”) Granted to Employees |
Below
is a table summarizing all the RSUs grants to employees during the period from January 1, 2024 to September 30, 2024:
SCHEDULE
OF RESTRICTED STOCK UNITS GRANTED
| |
No.
of Options Granted | | |
Vesting Period | |
Fair Value at Grant (in thousands) | |
Employees | |
| 8,250 | | |
5,000 Immediate and 3,250 quarterly over a period of two years | |
$ | 44 | |
|
c. |
Shares
and warrants issued to advisors. |
Below
is a table summarizing the shares and warrants grants to advisers during the period from January 1, 2024 to September 30, 2024:
SCHEDULE
OF SHARES AND WARRANTS GRANTS TO ADVISORS
Date of issue of share or warrant | |
Reason for issue of share or warrant | |
Consideration | |
Exercise price of warrants | | |
Warrant vesting (subject to continued service provided to Company) | |
Warrant expiry date |
March 7, 2024 | |
Strategic advisor agreement | |
50,000 shares of Common Stock and warrants to purchase 50,000 shares of Common Stock | |
$ | 10.3 | | |
One third on March 7, 2024, one third on June 5, 2024, and one third on September 3, 2024. | |
March 6, 2029 |
April 18, 2024 | |
Strategic advisor agreement | |
Warrants to purchase 50,000 shares of Common Stock | |
$ | 10.3 | | |
One third on April 18, 2024, one third on July 18, 2024, and one third on October 18, 2024. | |
April 17, 2029 |
April 23, 2024 | |
Strategic advisor agreement | |
Warrants to purchase 50,000 shares of Common Stock | |
$ | 10.3 | | |
One third on April 16, 2024, one third on July 16, 2024, and one third on October 16, 2024. | |
April 22, 2029 |
May 22, 2024 | |
Strategic advisor agreement | |
Warrants to purchase 47,500 shares of Common Stock | |
$ | 10.3 | | |
One third on May 21, 2024, one third on August 21, 2024, and one third on November 21, 2024. | |
May 21, 2029 |
July 14, 2024 | |
Strategic advisor agreement | |
Warrants to purchase 20,000 shares of Common Stock | |
$ | 10.3 | | |
One third on July 14, 2024, one third on October 14, 2024, and one third on January 14, 2024. | |
July 13, 2029 |
September 5, 2024 | |
Strategic advisor agreement | |
50,000 shares of Common | |
$ | 10.3 | | |
| |
|
| |
No.
of Warrants Granted | | |
Vesting Period | |
Fair Value at Grant (in thousands) | |
Warrants | |
| 217,500 | | |
Over a period of nine months | |
$ | 646 | |
Shares | |
| 50,000 | | |
N/A | |
$ | 350 | |
The
fair valuation of these shares grants is based on the market value of the share at the date of grant.
The
fair valuation of these warrants grants is based on the following assumptions:
SCHEDULE OF WARRANTS GRANTS
ASSUMPTIONS
| |
During the Period from January 1, 2024 to September 30, 2024 | |
Value of one common share | |
| $5.1-$8.4 | |
Dividend yield | |
| 0 | % |
Expected stock price volatility | |
| 87%-91 | % |
Risk free interest rate | |
| 4.07%-4.68 | % |
Expected term (years) | |
| 5 | |
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.3
LOSS PER SHARE
|
9 Months Ended |
Sep. 30, 2024 |
Earnings Per Share [Abstract] |
|
LOSS PER SHARE |
NOTE
9 – LOSS PER SHARE
The
following table sets forth the calculation of basic and diluted loss per share for the period indicated:
SCHEDULE
OF BASIC AND DILUTED LOSS PER SHARE
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands, except per share data) | |
Basic and diluted: | |
| | | |
| | | |
| | | |
| | |
Net loss attributable to Orgenesis Inc. | |
$ | 9,120 | | |
$ | 3,725 | | |
$ | 27,789 | | |
$ | 48,738 | |
Weighted average number of common shares outstanding | |
| 4,715,229 | | |
| 3,002,259 | | |
| 3,938,419 | | |
| 2,868,078 | |
Net loss per share | |
$ | 1.93 | | |
$ | 0.12 | | |
$ | 7.06 | | |
$ | 1.70 | |
For
the nine months ended September 30, 2024 and September 30, 2023, all outstanding convertible notes, options and warrants have been excluded
from the calculation of the diluted net loss per share since their effect was anti-dilutive.
Diluted
loss per share excludes 1,613,665 shares underlying outstanding options and warrants and 247,895 shares issuable upon conversion of convertible
loans for the nine months ended September 30, 2024, because the effect of their inclusion in the computation would be antidilutive. Diluted
loss per share excludes 1,825,724 shares underlying outstanding options and warrants and 247,895 shares issuable upon conversion of convertible
loans for the three months ended September 30, 2024, because the effect of their inclusion in the computation would be antidilutive.
Diluted
loss per share excludes 768,004 shares underlying outstanding options and warrants and 713,902 shares upon conversion of convertible
loans for the nine months ended September 30, 2023, because the effect of their inclusion in the computation would be antidilutive. Diluted
loss per share excludes 796,348 shares underlying outstanding options and warrants and 721,335 shares issuable conversion of convertible
loans for the three months ended September 30, 2023, because the effect of their inclusion in the computation would be antidilutive.
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- DefinitionThe entire disclosure for earnings per share.
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v3.24.3
REVENUES
|
9 Months Ended |
Sep. 30, 2024 |
Revenue from Contract with Customer [Abstract] |
|
REVENUES |
NOTE
10 – REVENUES
Disaggregation
of Revenue
The
following table disaggregates the Company’s revenues by major revenue streams:
SCHEDULE
OF DISAGGREGATION OF REVENUE
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Revenue stream: | |
| | | |
| | | |
| | | |
| | |
Cell process development services and hospital services | |
$ | 347 | | |
$ | 110 | | |
$ | 734 | | |
$ | 365 | |
Total | |
$ | 347 | | |
$ | 110 | | |
$ | 734 | | |
$ | 365 | |
A
breakdown of the revenues per customer constituted at least 10% of revenues is as follows:
SCHEDULE
OF BREAKDOWN OF REVENUES PER CUSTOMER
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Revenue earned: | |
| | | |
| | | |
| | | |
| | |
Customer A (United States) | |
$ | 265 | | |
$ | - | | |
$ | 265 | | |
$ | 130 | |
Customer B (United States) | |
$ | - | | |
$ | - | | |
$ | 300 | | |
$ | - | |
Revenue earned | |
$ | - | | |
$ | - | | |
$ | 300 | | |
$ | - | |
Contract
Assets and Liabilities
Contract
assets are mainly comprised of trade receivables net of allowance for doubtful debts, which includes amounts billed and currently due
from customers.
The
activity for trade receivables is comprised of:
SCHEDULE
OF ACTIVITY FOR TRADE RECEIVABLES
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Balance as of beginning of period | |
$ | 88 | | |
$ | 36,183 | |
Reconsolidation (deconsolidation) of Octomera | |
| 82 | | |
| (5,985 | ) |
Additions | |
| 458 | | |
| 403 | |
Collections | |
| (981 | ) | |
| (6,090 | ) |
Allowances for credit losses | |
| 512 | | |
| (24,388 | ) |
Exchange rate differences | |
| 2 | | |
| (52 | ) |
Balance as of end of period | |
$ | 161 | | |
$ | 71 | |
The
activity for contract liabilities is comprised of:
SCHEDULE
OF ACTIVITY FOR CONTRACT LIABILITIES
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Balance as of beginning of period | |
$ | 200 | | |
$ | 70 | |
Deconsolidation of Octomera | |
| 110 | | |
| (106 | ) |
Deconsolidation of OBI | |
| (60 | ) | |
| - | |
Deconsolidation | |
| (60 | ) | |
| - | |
Additions | |
| 160 | | |
| 156 | |
Realizations | |
| (279 | ) | |
| - | |
Balance as of end of period | |
$ | 131 | | |
$ | 120 | |
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v3.24.3
OTHER SIGNIFICANT TRANSACTIONS AND AGREEMENTS DURING THE NINE MONTHS ENDED SEPTEMBER 30, 2024
|
9 Months Ended |
Sep. 30, 2024 |
Other Significant Transactions And Agreements During Nine Months Ended September 30 2024 |
|
OTHER SIGNIFICANT TRANSACTIONS AND AGREEMENTS DURING THE NINE MONTHS ENDED SEPTEMBER 30, 2024 |
NOTE
11 – OTHER SIGNIFICANT TRANSACTIONS AND AGREEMENTS DURING THE NINE MONTHS ENDED SEPTEMBER 30, 2024
|
a. |
Asset
Purchase and Strategic Collaboration Agreement. |
On
April 5, 2024, the Company entered into an Asset Purchase and Strategic Collaboration Agreement (the “Purchase Agreement”)
with Griffin Fund 3 BIDCO, Inc., (“Germfree”), for the sale by the Company of five Orgenesis Mobile Processing Units and
Labs (“OMPULs”) to Germfree, which will be incorporated into Germfree’s lease fleet and leased back to the Company
or to third-party lessees designated by the Company. Pursuant to the Purchase Agreement, and subject to the terms and conditions set
forth therein, in consideration for the purchase of the OMPULs, the Orgenesis Quality Management Systems Framework (“OQMSF”)
and related intellectual property rights, Germfree is to pay an aggregate purchase price of $8,340 subject to adjustment through a verification
mechanism set forth in the Purchase Agreement. Pursuant to the Purchase Agreement, Germfree has paid the Company $6,720 as of September
30, 2024, which has been recorded under current liabilities.
On November 5, 2024, Germfree
notified the Company of its intention not to lease any OMPULS back to the Company. Germfree confirmed that it has satisfied its obligations
to the Company under the Purchase Agreement, and the Company therefore does not expect to receive any further payments thereunder. The
Company and Germfree plan to resolve any outstanding issues together.
|
b. |
Asset
Purchase Agreement with Broaden. |
On
July 10, 2024, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Broaden Bioscience
and Technology Corp. (“Broaden”) for the purchase by the Company of the following assets (the “Assets”): The
process and algorithms developed by Broaden for processing CAR-T, RACE CAR-T and all oncology products that will enable the Company
to develop and sell treatments to third parties, which include Broaden’s rights, title and interests in and to all
intellectual property, including, but not limited to, patents, patent applications, know-how, materials, licenses, permits and
approvals related thereto. Pursuant to the Purchase Agreement, in consideration for the purchase of the Assets, the Company will pay
Broaden an amount equal to the value of the Assets established with the assistance of a third party valuation firm not to exceed
$11,000
(the “Consideration”), less a debt adjustment relating to $10,767
owed to the Company by Broaden for work performed and invoiced (but fully impaired in the Company’s financial statements)
between August 2022 and May 2023 (the “Debt”), as detailed in the Purchase Agreement. The Consideration that exceeds the
Debt will be payable at the election of the Company in shares of the Company’s common stock at a price of $30.0
per share or 10%
above the market price at such time it is paid, whichever is higher, or a note with amortization in 24 months from the date of the
Purchase Agreement, including prepayment provisions. The Company accounted for the Purchase agreement by recording the difference
between the Consideration and Debt as research and development expenses, and the consideration that exceeds the debt was recorded in other long
term liabilities.
Asset
Purchase Agreement with Theracell.
On
July 12, 2024, the Company entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Theracell Advanced Biotechnology
S.A, Theracell Advanced Biotechnology LTD and IDNA Genomics Public Limited (collectively, “Theracell”) for the purchase by
the Company of the following assets (the “Assets”) owned by Theracell:
|
● |
50%
of the outstanding ownership rights and equity interests in Theracell Laboratories IKE (“Theracell IKE”) not currently
owned by the Company so that the Company shall own 100% of the outstanding equity interests of Theracell IKE; and |
|
|
|
|
● |
Certain
products (the “Products”), which include: (i) the manufacturing processes, algorithms, work instructions, test methods,
standard operating procedures and specifications for producing Tumor Infiltrating Lymphocytes (“TILs”) that meet current
Good Manufacturing Practice (cGMP) requirements that will enable the Company to potentially use this product as a platform for treating
a wide variety of solid tumors; (ii) a 3rd generation GMP lentivirus production process, which is part of a therapy manufacturing
process that will enable the Company to potentially treat Beta Thalassemia therapies; (iii) an oncolytic virus cell carrier platform
which will enable the Company to potentially develop treatments for an array of cancers; (iv) a process for the potential treatment
of mesenchymal stem cells for kidney disorders; (v) a process for controlled isolation of regenerative EVs derived from mesenchymal
stem cells for the potential treatment of kidney disorders; and (vi) bioxome encapsulated APIs for improved transdermal delivery
and bioavailability for the potential treatment of atopic dermatitis/wound healing; including Theracell’s rights, title and
interests in and to all intellectual property, including, but not limited to, patents, patent applications, know-how, materials,
licenses, permits and approvals relating to Products as further described in the Purchase Agreement. |
Pursuant
to the Purchase Agreement, in consideration for the purchase of the Assets, the Company will pay Theracell an aggregate purchase price
of $13,000
(the “Consideration”), which is equal
to the value of the Assets established with the assistance of a third-party valuation firm, less a debt adjustment in the amount of $10,324
which was owed (but fully impaired in the Company’s
financial statements) by Theracell to the Company (the “Debt”). The
aggregate Consideration will be paid by the Company as follows: (i) $400 will be paid to Theracell within 60 days after signing of the
Purchase Agreement, (ii) $250 will be paid to Theracell within one year after signing of the Purchase Agreement, and (iii) the remaining
amount (less any Debt) will be paid to Theracell in four equal annual payments beginning on December 30, 2025 and ending on December
30, 2028. As of the date of this quarterly report on Form 10-Q, the Company had paid Theracell $243. The Company accounted for the Purchase
agreement by recording the difference between the Consideration and Debt as research and development expenses, and the consideration
that exceeds the debt was recorded in short term or other long-term liabilities as appropriate.
Material
Definitive Agreement
On
August 9, 2024, the Company and Harley Street Healthcare Group (London) Plc Ltd. (“HSHG”) entered into a Strategic Partnership
Agreement (the “Agreement”) pursuant to which the Company and HSHG agreed to form a joint venture to collaborate in the clinical
development and commercialization of wellness and longevity-related services, including personalized preventative care and regenerative
therapies, which are to be offered on a subscription basis by HSHG in line with a planned offering of “Health & Wellness as
a Service” initially within the territory of the United Kingdom, the UAE, MENA, Canada, ASEAN, the Balkans, Africa, Latam and the
Indian Subcontinent (the “Territory”). Pursuant to the Agreement, any new joint venture entity to be formed (the “JV”)
will initially be owned 49% by the Company and 51% by HSHG. Thereafter, ownership of the JV entity will be based on each party’s
respective contributions, and control of the board of the JV entity will be based upon such percentage contributions. Until the parties
mutually agree to form the new JV entity, HSHG and the Company shall each carry out the respective tasks assigned to them for the implementation
of the project in accordance with the Agreement and the applicable work plan thereunder.
Pursuant
to the Agreement, HSHG agreed to invest (by the end of December 2024 for phase I) $5,000 in the Company’s shares of common stock
at a purchase price equal to the greater of (i) $10.3 per share (subject to adjustment for stock splits, consolidations and similar transactions)
or (ii) a 5% premium to the Nasdaq official closing price of the common stock of the Company at the time of HSHG’s investment.
Upon receipt by the Company of the $5,000 investment set forth above, HSHG will receive 485,437 three-year warrants to purchase 485,437
shares of the Company’s common stock at an exercise price equal to the greater of (i) $10.3 per share (subject to adjustment for
stock splits, consolidations and similar transactions) or (ii) a 10% premium to the Nasdaq official closing price of the Company’s
common stock. In addition, HSHG will have the option to provide up to $5,000 of additional funding for phase II, to be invested by December
31, 2025 in the Company’s shares of common stock under the same terms (the “Option”). The Option shall expire on the
one-year anniversary of the date which the Company receives the original investment from HSHG (the “Effective Date”). In
addition, following the Effective Date, HSHG will have the option to nominate a representative board member to join the Company’s
board of directors, subject to the Company obtaining the proper corporate approvals and the applicable rules and regulations of the Nasdaq
Stock Market.
The
Company shall contribute to the JV its intellectual property rights in the form of a license agreement to be entered into by the parties,
which will require that HSHG shall be solely responsible for payment of all costs of the manufacturing, distributing, marketing and/or
selling of the Company’s products within the Territory. In addition, the Company shall provide the know-how and tech transfer of
the Company’s products, and will support the JV and HSHG in the implementation of one or more products in the Territory, including
implementing the relevant Company quality management system, all as specified and detailed in the applicable work plan and the relevant
master services agreement. The Company will have the option to nominate a representative board member to join the JV and HSHG’s
board of directors, subject to HSHG obtaining the proper approval for adding a board member.
In
addition, each of the parties may provide additional funding in an amount to be mutually agreed by the parties, to cover the operations
costs of the project in accordance with the applicable work plan. Such additional investment may be in the form of an equity investment
for shares in the JV entity, a convertible loan, and/or procured services (the “Additional Investment”), if required (as
determined by the Parties) upon mutual agreement in order to continue the activities of the applicable project(s). The valuation of the
JV/any jointly controlled entities for the purposes of such Additional Investment will be mutually agreed by the parties or determined
with the assistance of an independent third-party expert to be mutually selected by the parties. Any Additional Investment by either party may result in
a dilution of the other party’s participating interest.
The
Company and HSHG shall have the right to purchase all of HSHG’s or the Company’s interest in the JV subject to all rules
and regulations to which it is then subject, including without limitation, the rules of any U.S. national securities exchange (“ORGS
Buy-Out”). In the event that the ORGS Buy-Out is implemented, then, for the purposes of the ORGS Buy-Out, the JV’s valuation
shall be determined by an independent third-party expert to be mutually selected by the parties.
As
of September 30, 2024 the JV entity had not been incorporated. As of the date of this quarterly report on Form 10-Q, no funds had yet
been received from HSHG.
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v3.24.3
LEGAL PROCEEDINGS
|
9 Months Ended |
Sep. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
LEGAL PROCEEDINGS |
NOTE
12 – LEGAL PROCEEDINGS
On
January 18, 2022, a complaint (the “Complaint”) was filed in the Tel Aviv District Court (the “Court”) against
the Company, Orgenesis Ltd (“the Israeli Subsidiary”), Prof. Sarah Ferber, Vered Caplan and Dr. Efrat Asa Kunik (collectively,
the “defendants”) by plaintiffs the State of Israel, as the owner of Chaim Sheba Medical Center at Tel Hashomer (“Sheba”),
and Tel Hashomer Medical Research, Infrastructure and Services Ltd. (collectively, the “plaintiffs”). In the Complaint, the
plaintiffs are seeking that the Court issue a declaratory remedy whereby the defendants are required to pay royalties to the plaintiffs
at the rate of 7% of the sales and 24% of any and all revenues in consideration for sublicenses related to any product, service or process
that contain know-how and technology of Sheba and any and all know-how and technology either developed or supervised by Prof. Ferber
in the field of cell therapy, including in the category of the point-of-care platform and any and all services and products in relation
to the defendants’ CDMO activity. In addition, the plaintiffs seek that the defendants provide financial statements and pay NIS
10,000 to the plaintiffs due to the royalty provisions of the license agreement, dated February 2, 2012, between the Israeli subsidiary
and Tel Hashomer Medical Research, Infrastructure and Services Ltd. (the “License Agreement”). The Complaint alleges that
the Company and the Israeli subsidiary used know-how and technology of Sheba and know-how and technology either developed or supervised
by Prof. Ferber while employed by Sheba in the field of cell therapy, including in the category of the point-of-care platform and the
services and products in relation to the defendants’ CDMO activity and are entitled to the payment of certain royalties pursuant
to the terms of the License Agreement. The defendants have filed their statements of defense responding to this Complaint, the Plaintiffs
filed their response and the parties are now conducting disclosure proceedings in accordance with Israel’s civil regulations. In
accordance with Israel’s civil regulations, the parties considered alternative means to resolve at least some of the disputes and
have consented to engage the services of a mutually agreeable mediator. The mediation is currently taking place. According to management’s
estimation, since a loss is not considered probable, no provision was made in the financial statements.
On
September 6, 2023, a claim (the “Claim”) was filed in the Tel Aviv District Court (the “Court”) against the Company,
the Israeli Subsidiary, Octomera LLC, Orgenesis Biotech Israel Ltd, Theracell Laboratories Private Company and Vered Caplan (collectively,
the “defendants”) by Ehud Almon (Plaintiff) for certain finders’ fees and / or royalties related to sales made by an
Octomera subsidiary to a Greek entity in the amount of $896 and also for other means of compensation. The Israeli Subsidiary and Vered
Caplan filed their statement of defense on January 28, 2024 claiming, inter alia, that the Plaintiff did not serve as a broker, but rather
served as the Greek entity’s representative and as such he is not entitled to compensation of any kind from the defendants. It
was also clarified that the defendants did not enter into a finder’s agreement with the Plaintiff. Additionally, the Israeli subsidiary
and Vered Caplan claimed that the Plaintiff concealed material information from the court, including the signed partnership agreement
between the Greek entity’s owner and the Plaintiff, as well as certain criminal charges brought against him in Greece. On February
22, 2024, the Plaintiff filed a request for service of process to deliver the Claim to the Company and the other defendants incorporated
outside of Israel. This request was denied on the same day. An appeal filed by the Plaintiff on the aforementioned decision was denied.
On May 27, 2024, the Plaintiff filed a new request for service of process to deliver the Claim to the Company and the other defendants
incorporated outside of Israel. On May 28, 2024 the request was accepted. The court ruled that the Claim be delivered via courier to
the Company and Octomera LLC, and delivered in accordance with the Hague Convention to Theracell Laboratories. After requesting a continuance,
on September 18, 2024, the Plaintiff filed an update that the Claim was
delivered to the Company and Octomera LLC on August 16, 2024. On the same day, the Claimant also filed a motion, petitioning that the
Claim will be delivered to Theracell Laboratories via the Company or via Vered Caplan, in order to minimize the costs of translating and
delivering the Claim to Greece. On October 7, 2024 Vered Caplan filed her opposition to the abovementioned motion, claiming that there
is no legal basis for the Claimant’s request, especially since the ruling regarding the service of process was made per the Plaintiff’s
request. On October 10, 2024 the Company filed its opposition to the request, on the same basis, mentioning, inter alia, that the claim
itself has no connection to Israel and that the Israeli courts are not the appropriate forum for the Plaintiff’s claims. Ruling
on the abovementioned motion is pending. According
to management’s estimation, since the likelihood of the Plaintiff winning the case is less than fifty percent, no provision was
made in the financial statements.
On
October 26, 2023, a complaint was filed in the Supreme Court of the State of New York by plaintiffs Southern Israel Bridging Fund Two
LP and Mr. Amir Hasidim, against the Company, seeking the payment of $1,150 together with interest in the amount of 6%. In the Complaint
plaintiffs alleged the amount provided to the Company was based on a Convertible Loan Agreement dated May 17, 2022, which provided for
a loan amount of $5,000. Notwithstanding the Convertible Loan Agreement, on August 21, 2023, Company sent the plaintiffs an offset notice
in light of the plaintiffs’ breach of obligations under the Convertible Loan Agreement and the damages caused to the Company as
a result of said breach. The Company counter sued as well, seeking damages for Plaintiff’s breach of contract, fraud and harassment.
Accordingly, the Company disputes whether it owes plaintiffs the amount sought in the Complaint.
On
November 1, 2023, a claim (the “Claim”) was filed in the Tel Aviv District Court (the “Court”) against the Company,
the Israeli Subsidiary, and Vered Caplan (collectively, the “Defendants”) by Fidelity Venture Capital Ltd. and Dror Atzmon
(together – the “Plaintiffs”). The claim is based on two agreements the Company entered into with the Plaintiffs on
November 2, 2016: (a) an unsecured convertible note agreements for an aggregate amount of NIS 1 million ($280). The loan bears a monthly
interest rate of 2% and will mature on May 1, 2017, unless converted earlier and (b) a consultation agreement which awarded the Plaintiffs
80 thousand warrants. The exercise price of the warrants and conversion price were fixed at $5.2 per share (pre-reverse stock split implemented
by the Company in November 2017). On April 27, 2017, and November 2, 2017, the Company entered into extension agreements through November
2, 2017 and May 2, 2018, respectively, in connection with the convertible note agreements. In March 2018, the Plaintiffs submitted a
notice of their intention to convert into shares the Company’s common stock, the principal amount of the loan, and accrued interest
of approximately $383 outstanding. In addition, the Plaintiffs exercised all the warrants awarded in the consultation agreement. In light
of the reverse stock split which took place in November 2017, the Company disagreed with the plaintiffs’ calculations regarding
the number of issuable shares of Common Stock. The Company responded to the notice and rejected these contentions in their entirety.
In April 2018, the Company terminated the agreements based on several claims, including mistake, intentional misrepresentation and bad
faith. Therefore, the Company deposited the shares in total amount of 10,798 issued under those agreements and the principal amount and
accrued interest of the loan in an escrow account. The deposit of the principal amount and accrued interest presented as restricted cash
in the balance sheet as of December 31, 2023. Based on the calculation difference, in their Claim, the Plaintiffs request damages in
the amount of NIS 40,140, and the issuance of 1,186,960 shares of the Company. The Defendants filed their statement of defense on April
15, 2024, in which they raised, among others, the aforementioned claims and additional procedural and substantial claims, including laches. The parties have agreed to start mediation
proceeding in connection with the Claim. According to management’s estimation, since the likelihood of the Plaintiffs winning the
case is less than fifty percent, no provision was made in the financial statements.
On
July 11, 2024 the Israeli subsidiary reached a settlement agreement regarding unpaid rentals sanctioned by the Tel Aviv Magistrate’s
court pursuant to which the subsidiary will pay the amount of NIS 427,000 (approximately $114) including VAT to the lessor of leased
premises no later than September 30, 2024, which includes a grace period for late payments. As of the date of this quarterly report on
Form 10-Q, the Company had paid all of the settlement amount less $12, and the lessor agreed to defer payment of the $12 to December 28, 2024. In the event that the Company fails to meet all of its obligations under the settlement agreement, the Company may be liable
to pay an additional NIS 211,000 (approximately $57) over and above the amount still due, in respect of claims for unpaid rentals made
by the lessor.
Except
as described above, the Company is not involved in any pending material legal proceedings.
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- DefinitionThe entire disclosure for legal proceedings, legal contingencies, litigation, regulatory and environmental matters and other contingencies.
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v3.24.3
SUBSEQUENT EVENTS
|
9 Months Ended |
Sep. 30, 2024 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
13 – SUBSEQUENT EVENTS
On
November 8, 2024, the two Belgian subsidiaries of the Company, viz. Orgenesis Belgium SRL and
Orgenesis Services SRL (“the Belgian subsidiaries”), petitioned the Liège Business Court in Belgium for allowing their
judicial reorganization pursuant to Article XX.41 of the Belgian Code of Economic Law. The petition follows the current inability of the
Belgian subsidiaries to pay employee payroll expenses and accounts payable. The Company has requested a 6-month reorganization period.
The Liège Business Court has agreed to consider the petition, and the next hearing will take place on November 22, 2024.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.24.3
BASIS OF PRESENTATION (Policies)
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of presentation |
a.
Basis of presentation
The
accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated financial
statements. In the opinion of management, the financial statements reflect all normal and recurring adjustments necessary to fairly state
the financial position and results of operations of the Company. The information included in this Quarterly Report on Form 10-Q should
be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Annual Report
on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission (“SEC”) on April
15, 2024. The year-end balance sheet data was derived from the audited consolidated financial statements as of December 31, 2023, but
not all disclosures required by generally accepted accounting principles in the United States (“U.S. GAAP”) are included
in this Quarterly Report on Form 10-Q.
b.
Significant accounting policies
The
accounting policies adopted are consistent with those of the previous financial year except as described below:
|
Use of Estimates in the Preparation of Financial Statements |
Use
of Estimates in the Preparation of Financial Statements
The
preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires us to make estimates, judgments
and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of
contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies. The Company
bases its estimates on historical experience and on various other assumptions that it believes are reasonable, the results of which form
the basis for making judgments about the carrying values of assets, liabilities and equity, the amount of revenues and expenses, determination
of loss on deconsolidation, valuation of investments, purchase price allocations, goodwill impairment, and assessment of credit losses
and purchase price allocation including contingent consideration. Actual results could differ from those estimates.
|
Recently issued accounting pronouncements, not yet adopted |
Recently
issued accounting pronouncements, not yet adopted
Improvements
to Public Business Entity’s Expenses Disclosures
In
November 2024, the FASB issued ASU No. 2024-03 Income Statement—Reporting Comprehensive Income—Expense Disaggregation
Disclosures (Subtopic 220-40). The ASU improves the disclosures about a public business entity’s expenses and provides more detailed
information about the types of expenses in commonly presented expense captions. The amendments require that at each interim and annual
reporting period an entity will, inter alia, disclose amounts of purchases of inventory, employee compensation, depreciation and amortization
included in each relevant expense caption (such as cost of sales, SG&A and research and development). The ASU is effective for fiscal
years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption
is permitted. The Company is currently evaluating this ASU to determine its impact on the Company’s disclosures.
Improvements
to Reportable Segments Disclosures
In
November 2023, the FASB issued ASU 2023-07 “Segment Reporting–Improvements to Reportable Segments Disclosures (Topic 280)”
to improve reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The
amendments in this ASU (1) require that a public entity disclose, on an annual and interim basis, significant segment expenses that are
regularly provided to the chief operating decision maker (“CODM”) and included within each reported measure of segment profit
or loss; (2) require that a public entity disclose, on an annual and interim basis, an amount for other segment items by reportable segment
and a description of its composition; (3) require that a public entity provide all annual disclosures about a reportable segment’s
profit or loss and assets currently required by Topic 280 in interim periods; (4) clarify that if the CODM uses more than one measure
of a segment’s profit or loss in assessing segment performance and deciding how to allocate resources, a public entity may report
one or more of those additional measures; and (5) require that a public entity disclose the title and position of the CODM and an explanation
of how the CODM uses the reported measure or measures of segment profit or loss in assessing segment performance and deciding how to
allocate resources. The amendments in this ASU are effective for fiscal years beginning after December 15, 2023, and interim periods
within fiscal years beginning after December 15, 2024, and should be applied retrospectively to all periods presented. Early adoption
is permitted. The Company is currently evaluating the impact of the adoption of these amendments on its consolidated financial statements.
Improvements
to Income Tax Disclosures
In
December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740)–Improvements to Income Tax Disclosures” to enhance
the transparency and decision usefulness of income tax disclosures, primarily related to the rate reconciliation and income taxes paid
information. The amendments in this ASU require that public entities, on an annual basis, disclose specific categories in the rate reconciliation
and provide additional information for reconciling items that meet a quantitative threshold. This ASU also requires that all entities
disclose, on an annual basis, (1) the amount of income taxes paid disaggregated by federal, state, and foreign taxes, (2) the amount
of income taxes paid disaggregated by individual jurisdictions in which income taxes paid is equal to or greater than five percent of
total income taxes paid, (3) income or loss from continuing operations before income tax expense or benefit disaggregated between domestic
and foreign, and (4) income tax expense or benefit from continuing operations disaggregated by federal, state, and foreign. The amendments
in this ASU are effective for annual periods beginning after December 15, 2024, and should be applied on a prospective basis with the
option to apply retrospectively. Early adoption is permitted for annual financial statements that have not yet been issued or made available
for issuance. The Company is currently evaluating the impact of the adoption of these amendments on its consolidated financial statements.
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v3.24.3
SEGMENT INFORMATION (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Segment Reporting [Abstract] |
|
SCHEDULE OF SEGMENT REPORTING |
Segment
data for the nine months ended September 30, 2024 is as follows:
SCHEDULE OF SEGMENT REPORTING
| |
Octomera | | |
Therapies | | |
Eliminations | | |
Consolidated | |
| |
(in
thousands) | |
Revenues | |
$ | 322 | | |
$ | 435 | | |
$ | (23 | ) | |
$ | 734 | |
Cost of revenues* | |
| (1,292 | ) | |
| (521 | ) | |
| 710 | | |
| (1,103 | ) |
Gross profit | |
| (970 | ) | |
| (86 | ) | |
| 687 | | |
| (369 | ) |
Cost of development services and research
and development expenses* | |
| (4,542 | ) | |
| (4,079 | ) | |
| 699 | | |
| (7,922 | ) |
Operating expenses* | |
| (1,226 | ) | |
| (9,012 | ) | |
| (728 | ) | |
| (10,966 | ) |
Impairment expenses ** | |
| - | | |
| (692 | ) | |
| - | | |
| (692 | ) |
Loss from deconsolidation | |
| - | | |
| - | | |
| (66 | ) | |
| (66 | ) |
Other income | |
| (126 | ) | |
| 12 | | |
| - | | |
| (114 | ) |
Depreciation and amortization | |
| (1,171 | ) | |
| (581 | ) | |
| 127 | | |
| (1,625 | ) |
Loss from extinguishment in connection with
convertible loan | |
| - | | |
| (141 | ) | |
| - | | |
| (141 | ) |
Credit losses on convertible loan receivable | |
| | | |
| | | |
| | | |
| | |
Financial income (expenses), net | |
| (756 | ) | |
| (1,752 | ) | |
| 123 | | |
| (2,385 | ) |
Convertible loans induced
conversion expenses | |
| - | | |
| (4,304 | ) | |
| - | | |
| (4,304 | ) |
Share in net income of associated companies | |
| | | |
| | | |
| | | |
| | |
* | Excluding Depreciation,
amortization expenses |
** | Relates to impairment expenses on certain property, plant and equipment. |
Segment
data for the nine months ended September 30, 2023 is as follows:
| |
Octomera | | |
Therapies | | |
Eliminations | | |
Consolidated | |
| |
(in
thousands) | |
Revenues | |
$ | 44 | | |
$ | 350 | | |
$ | (29 | ) | |
$ | 365 | |
Cost of revenues* | |
| (6,959 | ) | |
| (531 | ) | |
| 1,874 | | |
| (5,616 | ) |
Gross profit | |
| (6,915 | ) | |
| (181 | ) | |
| 1,845 | | |
| (5,251 | ) |
Cost of development services and research
and development expenses* | |
| (6,828 | ) | |
| (2,830 | ) | |
| 2,327 | | |
| (7,331 | ) |
Operating expenses* | |
| (31,921 | ) | |
| (4,962 | ) | |
| 3,930 | | |
| (32,953 | ) |
Loss from deconsolidation of Octomera | |
| - | | |
| - | | |
| (5,343 | ) | |
| (5,343 | ) |
Other income, net | |
| 2 | | |
| 2 | | |
| | | |
| 4 | |
Depreciation and amortization | |
| (1,294 | ) | |
| (589 | ) | |
| 517 | | |
| (1,366 | ) |
Loss from extinguishment in connection with
convertible loan | |
| - | | |
| (283 | ) | |
| - | | |
| (283 | ) |
Credit losses on convertible loan receivable | |
| - | | |
| (2,688 | ) | |
| - | | |
| (2,688 | ) |
Financial (expenses) income, net | |
| (587 | ) | |
| (1,425 | ) | |
| 94 | | |
| (1,918 | ) |
Share in net income of
associated companies | |
| - | | |
| (10 | ) | |
| (542 | ) | |
| (552 | ) |
* | Excluding Depreciation,
amortization expenses |
Segment
data for the three months ended September 30, 2024 is as follows:
| |
Octomera | | |
Therapies | | |
Eliminations | | |
Consolidated | |
| |
(in thousands) | |
Revenues | |
$ | 272 | | |
$ | 75 | | |
$ | - | | |
$ | 347 | |
Cost of revenues* | |
| (245 | ) | |
| (192 | ) | |
| - | | |
| (437 | ) |
Gross profit | |
| 27 | | |
| (117 | ) | |
| - | | |
| (90 | ) |
Cost of development services and research and development expenses* | |
| (1,291 | ) | |
| (3,048 | ) | |
| 2 | | |
| (4,337 | ) |
Operating expenses* | |
| (680 | ) | |
| (1,975 | ) | |
| (82 | ) | |
| (2,737 | ) |
Impairment expenses** | |
| - | | |
| (692 | ) | |
| - | | |
| (692 | ) |
Other income | |
| (126 | ) | |
| 4 | | |
| - | | |
| (122 | ) |
Depreciation and amortization | |
| (301 | ) | |
| (194 | ) | |
| (43 | ) | |
| (538 | ) |
Financial expenses, net | |
| (202 | ) | |
| (515 | ) | |
| (1 | ) | |
| (718 | ) |
* | Excluding Depreciation,
amortization expenses |
** | Relates to impairment expenses on certain property, plant and equipment. |
Segment
data for the three months ended September 30, 2023 is as follows:
| |
Octomera | | |
Therapies | | |
Eliminations | | |
Consolidated | |
| |
(in
thousands) | |
Revenues | |
$ | 29 | | |
$ | 110 | | |
$ | (29 | ) | |
$ | 110 | |
Cost of revenues* | |
| (1,875 | ) | |
| (133 | ) | |
| 1,874 | | |
| (134 | ) |
Gross profit | |
| (1,846 | ) | |
| (23 | ) | |
| 1,845 | | |
| (24 | ) |
Cost of development services and research
and development expenses* | |
| (2,327 | ) | |
| (779 | ) | |
| 2,327 | | |
| (779 | ) |
Operating expenses* | |
| (3,931 | ) | |
| (1,240 | ) | |
| 3,930 | | |
| (1,241 | ) |
Other income | |
| - | | |
| 2 | | |
| - | | |
| 2 | |
Depreciation and amortization | |
| (515 | ) | |
| (193 | ) | |
| 517 | | |
| (191 | ) |
Financial (expenses) income, net | |
| (92 | ) | |
| (546 | ) | |
| 93 | | |
| (545 | ) |
Share in net income of
associated companies | |
| - | | |
| (11 | ) | |
| (542 | ) | |
| (553 | ) |
* | Excluding Depreciation,
amortization expenses |
|
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v3.24.3
RECONSOLIDATION OF OCTOMERA LLC (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Restructuring Cost and Reserve [Line Items] |
|
SCHEDULE OF DECONSOLIDATE ASSETS AND LIABILITIES |
The
following table summarizes the allocation of purchase price to the fair values of the assets acquired and liabilities assumed as of the
Transaction date:
SCHEDULE OF PURCHASE PRICE TO THE FAIR VALUES OF THE ASSETS ACQUIRED AND LIABILITIES ASSUMED
| |
(in
thousands) | |
Total Contingent
consideration to MM for royalty and milestone payments | |
$ | 4,643 | |
| |
| | |
Total assets acquired: | |
| | |
Cash and cash equivalents | |
$ | 139 | |
Property, plants and equipment,
net | |
| 17,852 | |
Other
Assets | |
| 3,478 | |
Total
assets | |
$ | 21,469 | |
| |
| | |
Total liabilities assumed: | |
| | |
Total current liabilities | |
$ | (12,518 | ) |
Total
long-term liabilities | |
| (5,628 | ) |
Total
liabilities | |
$ | (18,146 | ) |
| |
| | |
Know
how Technology | |
| 1,728 | |
| |
| | |
Total
Net Assets | |
$ | 5,051 | |
Fair-Value
of Non-controlling interests | |
| (408 | ) |
Total
liability to MM | |
$ | 4,643 | |
|
SCHEDULE OF KEY INPUTS FOR THE FAIR VALUES VALUATION |
Key
inputs for the fair values valuation are summarized below.
SCHEDULE OF
KEY INPUTS FOR THE FAIR VALUES VALUATION
Key Valuation
Inputs | |
Jan
29, 2024 | |
Discount rate | |
| 40 | % |
Risk-free interest rate | |
| 4.4 | % |
Average 5 years revenue growth | |
| 50 | % |
Measurement input | |
| 50 | % |
|
SCHEDULE OF KEY INPUTS |
Key
inputs for the simulation are summarized below.
SCHEDULE
OF KEY INPUTS
Key Valuation
Inputs | |
Jan
29, 2024 | | |
September
30, 2024 | |
Standard Deviation | |
| 13.5 | % | |
| 13.6 | % |
Risk-free interest rate | |
| 4.4 | % | |
| 4.2 | % |
Possible trigger event examination | |
| Year
10 | | |
| Year
9.5 | |
Average 5 years revenue growth | |
| 50 | % | |
| 50 | % |
Trigger events | |
| 30 | % | |
| 30 | % |
EV/EBIT Multiple | |
| 11.1 | | |
| 11.1 | |
* | Based on a Monte
Carlo simulation analysis of 30,000 iterations |
|
Orgenesis Biotech Israel Limited [Member] |
|
Restructuring Cost and Reserve [Line Items] |
|
SCHEDULE OF DECONSOLIDATE ASSETS AND LIABILITIES |
The
following table summarizes the deconsolidated assets and liabilities as of February 14, 2024:
SCHEDULE
OF DECONSOLIDATE ASSETS AND LIABILITIES
| |
| |
Total assets acquired: | |
| | |
Cash and cash
equivalents | |
$ | 4 | |
Property, plants and equipment,
net | |
| 2,884 | |
Other
Assets | |
| 1,422 | |
Total
assets | |
$ | 4,310 | |
| |
| | |
Total
liabilities assumed: | |
$ | 4,244 | |
Total
Net Assets deconsolidated | |
$ | 66 | |
Loss
from deconsolidation of OBI | |
$ | 66 | |
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v3.24.3
CONVERTIBLE LOANS (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Debt Disclosure [Abstract] |
|
SCHEDULE OF LONG TERM CONVERTIBLE NOTES |
The
table below summarizes the Company’s outstanding convertible loans as of September 30, 2024.
SCHEDULE OF LONG TERM CONVERTIBLE NOTES
Principal Amount | | |
Issuance Date | | |
Current Interest Rate | | |
Current Maturity | | |
Current Conversion Price of loan into equity | |
at Issuance | | |
(Year) | | |
% | | |
(Year) | | |
$ | |
$ | 100 | | |
| 2019 | | |
| 8 | % | |
| 2024 | | |
| 10.3 | |
| 100 | | |
| 2020 | | |
| 8 | % | |
| 2024 | | |
| 10.3 | |
| 1,150 | | |
| 2022 | | |
| 6 | % | |
| *2023 | | |
| 45.0 | |
| 5,000 | | |
| 2023 | | |
| 8 | % | |
| 2026 | | |
| 24.6 | |
$ | 6,350 | | |
| | | |
| | | |
| | | |
| | |
|
* |
Was
not repaid by September 30, 2024. |
The
table below summarizes the Company’s outstanding convertible loans as of December 31, 2023.
Principal | | |
Issuance Date | | |
Current Interest Rate | | |
Current Maturity | | |
Current Conversion Price of loan into equity | | |
| |
Amount | | |
(Year) | | |
% | | |
(Year) | | |
$ | | |
Note | |
Convertible Loans Outstanding as of December 31, 2023 | | |
| |
$ | 750 | | |
| 2018 | | |
| 10 | % | |
| 2026 | | |
| 25.0 | | |
| | |
| 1,500 | | |
| 2019 | | |
| 10 | % | |
| 2026 | | |
| 25.0 | | |
| | |
| 100 | | |
| 2019 | | |
| 8 | % | |
| 2024 | | |
| 70.0 | | |
| | |
| 5,000 | | |
| 2019 | | |
| 10 | % | |
| 2026 | | |
| 25.0 | | |
| | |
| 100 | | |
| 2020 | | |
| 8 | % | |
| 2024 | | |
| 70.0 | | |
| | |
| 5,000 | | |
| 2022 | | |
| 10 | % | |
| 2026 | | |
| 25.0 | | |
| | |
| 1,150 | | |
| 2022 | | |
| 6 | % | |
| **2023 | | |
| 45.0 | | |
| | |
| 5,000 | | |
| 2023 | | |
| 8 | % | |
| 2026 | | |
| 24.6 | | |
| | |
| 735 | | |
| 2023 | | |
| 8 | % | |
| 2024 | | |
| 08.5 | | |
| | |
$ | 19,335 | | |
| | | |
| | | |
| | | |
| | | |
| | |
|
** |
Was
not yet paid by December 31, 2023. |
|
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v3.24.3
LOANS (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Loans |
|
SCHEDULE OF LONG TERM LOANS |
The
table below summarizes the Company’s outstanding long-term loans as of September 30, 2024 and December 31, 2023, respectively:
SCHEDULE OF LONG TERM LOANS
Principal Amount | | |
Interest Rate | | |
Year of Maturity | | |
September 30, 2024 | | |
December31, 2023 | |
(in thousands) | | |
% | | |
| | |
(in thousands) | |
$ | 2,600 | | |
| 10 | | |
| 2034 | | |
$ | 2,828 | | |
$ | - | |
|
SCHEDULE OF SHORT TERM LOANS |
The
table below summarizes the Company’s outstanding short-term loans as of September 30, 2024 and December 31, 2023, respectively:
SCHEDULE OF SHORT TERM LOANS
Currency | |
Interest Rate | | |
September 30, 2024 | | |
December 31, 2023 | |
| |
% | | |
(in thousands) | |
USD | |
| 8 | | |
$ | 287 | | |
$ | 258 | |
USD | |
| 10 | | |
| 4,603 | | |
| 61 | |
USD | |
| (*)8 | | |
| - | | |
| (**)331 | |
Euro | |
| 8 | | |
| 15 | | |
| - | |
| |
| | | |
$ | 4,905 | | |
$ | 650 | |
(*) | | Weighted average
interest. |
(**) | | The terms of the
loan were amended on January 1, 2024. Under the new terms, the loan became convertible into shares of Common Stock and the lender agreed
to extend the maturity date to December 31, 2024. In consideration for such extension, the Company issued to the lender warrants to purchase
36,000 shares of the Company’s Common Stock at a price of $8.5 per share and granted lender the right to convert any part of the
outstanding balance of the loan into Common Stock of the Company at the conversion rate of $8.5 per share. Based on its analysis, the
Company concluded that this change in terms should be accounted for as a modification. This loan was converted as per the debt exchange
agreement. See note 6. |
|
SCHEDULE OF WARRANTS GRANTED |
The
table below summarizes the Company’s warrants granted to loan holders for the period ended September 30, 2024.
SCHEDULE
OF WARRANTS GRANTED
Date of issuance | |
Reason for issuance | |
Number of warrants | | |
Weighted Average Exercise price | | |
Warrant vesting (subject to continued service provided to Company) | |
Expiration date |
April 07, 2024 | |
Loan Agreement | |
| 15,625 | | |
$ | 8 | | |
Immediate | |
October 06, 2024 |
April 05, 2024 | |
Loan Agreement | |
| 21,875 | | |
$ | 8 | | |
Immediate | |
October 04, 2024 |
August 21, 2024 | |
Loan Agreement | |
| 24,272 | | |
$ | 10.3 | | |
Immediate | |
August 20, 2029 |
August 21, 2024 | |
Loan Agreement | |
| 97,088 | | |
$ | 10.3 | | |
Immediate | |
August 20, 2029 |
September 06, 2024 | |
Loan Agreement | |
| 24,272 | | |
$ | 10.3 | | |
Immediate | |
September 05, 2025 |
September 10, 2024 | |
Loan Agreement | |
| 1,942 | | |
$ | 10.3 | | |
Immediate | |
September 09, 2025 |
September 09, 2024 | |
Loan Agreement | |
| 24,272 | | |
$ | 10.3 | | |
Immediate | |
September 08, 2029 |
September 17, 2024 | |
Loan Agreement | |
| 24,272 | | |
$ | 10.3 | | |
Immediate | |
September 16, 2029 |
September 30, 2024 | |
Loan Agreement | |
| 14,563 | | |
$ | 10.3 | | |
Immediate | |
September 29, 2025 |
Total | |
| |
| 248,181 | | |
$ | 10.0 | | |
| |
|
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v3.24.3
STOCK-BASED COMPENSATION (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] |
|
SCHEDULE OF RESTRICTED STOCK UNITS GRANTED |
Below
is a table summarizing all the RSUs grants to employees during the period from January 1, 2024 to September 30, 2024:
SCHEDULE
OF RESTRICTED STOCK UNITS GRANTED
| |
No.
of Options Granted | | |
Vesting Period | |
Fair Value at Grant (in thousands) | |
Employees | |
| 8,250 | | |
5,000 Immediate and 3,250 quarterly over a period of two years | |
$ | 44 | |
|
SCHEDULE OF SHARES AND WARRANTS GRANTS TO ADVISORS |
Below
is a table summarizing the shares and warrants grants to advisers during the period from January 1, 2024 to September 30, 2024:
SCHEDULE
OF SHARES AND WARRANTS GRANTS TO ADVISORS
Date of issue of share or warrant | |
Reason for issue of share or warrant | |
Consideration | |
Exercise price of warrants | | |
Warrant vesting (subject to continued service provided to Company) | |
Warrant expiry date |
March 7, 2024 | |
Strategic advisor agreement | |
50,000 shares of Common Stock and warrants to purchase 50,000 shares of Common Stock | |
$ | 10.3 | | |
One third on March 7, 2024, one third on June 5, 2024, and one third on September 3, 2024. | |
March 6, 2029 |
April 18, 2024 | |
Strategic advisor agreement | |
Warrants to purchase 50,000 shares of Common Stock | |
$ | 10.3 | | |
One third on April 18, 2024, one third on July 18, 2024, and one third on October 18, 2024. | |
April 17, 2029 |
April 23, 2024 | |
Strategic advisor agreement | |
Warrants to purchase 50,000 shares of Common Stock | |
$ | 10.3 | | |
One third on April 16, 2024, one third on July 16, 2024, and one third on October 16, 2024. | |
April 22, 2029 |
May 22, 2024 | |
Strategic advisor agreement | |
Warrants to purchase 47,500 shares of Common Stock | |
$ | 10.3 | | |
One third on May 21, 2024, one third on August 21, 2024, and one third on November 21, 2024. | |
May 21, 2029 |
July 14, 2024 | |
Strategic advisor agreement | |
Warrants to purchase 20,000 shares of Common Stock | |
$ | 10.3 | | |
One third on July 14, 2024, one third on October 14, 2024, and one third on January 14, 2024. | |
July 13, 2029 |
September 5, 2024 | |
Strategic advisor agreement | |
50,000 shares of Common | |
$ | 10.3 | | |
| |
|
| |
No.
of Warrants Granted | | |
Vesting Period | |
Fair Value at Grant (in thousands) | |
Warrants | |
| 217,500 | | |
Over a period of nine months | |
$ | 646 | |
Shares | |
| 50,000 | | |
N/A | |
$ | 350 | |
|
SCHEDULE OF WARRANTS GRANTS ASSUMPTIONS |
The
fair valuation of these warrants grants is based on the following assumptions:
SCHEDULE OF WARRANTS GRANTS
ASSUMPTIONS
| |
During the Period from January 1, 2024 to September 30, 2024 | |
Value of one common share | |
| $5.1-$8.4 | |
Dividend yield | |
| 0 | % |
Expected stock price volatility | |
| 87%-91 | % |
Risk free interest rate | |
| 4.07%-4.68 | % |
Expected term (years) | |
| 5 | |
|
Options Granted To Employees [Member] |
|
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] |
|
SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES |
The
table below summarizes the terms of options for the purchase of shares in the Company granted to employees during the period from January
1, 2024 to September 30, 2024:
SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES
| |
No.
of Options Granted | | |
Exercise
Price | | |
Vesting Period | |
Fair Value at Grant (in
thousands) | | |
Expiration Period |
Employees | |
| 126,912 | | |
| $5.0-$10.3 | | |
41,100 quarterly over a period of two years, 20,000 quarterly over a period of four years, 1,250 annually over a period of three years and 64,563 immediate | |
$ | 655 | | |
10 years |
|
SCHEDULE OF STOCK OPTIONS ACTIVITY |
The
fair valuation of these option grants is based on the following assumptions:
SCHEDULE
OF STOCK OPTIONS ACTIVITY
| |
During the Period from January 1, 2024 to September 30, 2024 | |
Value of one common share | |
| $4.9-$10.3 | |
Dividend yield | |
| 0 | % |
Expected stock price volatility | |
| 79%-110 | % |
Risk free interest rate | |
| 3.86%-4.49 | % |
Expected term (years) | |
| 2.50-6.06 | |
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v3.24.3
LOSS PER SHARE (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Earnings Per Share [Abstract] |
|
SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE |
The
following table sets forth the calculation of basic and diluted loss per share for the period indicated:
SCHEDULE
OF BASIC AND DILUTED LOSS PER SHARE
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands, except per share data) | |
Basic and diluted: | |
| | | |
| | | |
| | | |
| | |
Net loss attributable to Orgenesis Inc. | |
$ | 9,120 | | |
$ | 3,725 | | |
$ | 27,789 | | |
$ | 48,738 | |
Weighted average number of common shares outstanding | |
| 4,715,229 | | |
| 3,002,259 | | |
| 3,938,419 | | |
| 2,868,078 | |
Net loss per share | |
$ | 1.93 | | |
$ | 0.12 | | |
$ | 7.06 | | |
$ | 1.70 | |
|
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v3.24.3
REVENUES (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Revenue from Contract with Customer [Abstract] |
|
SCHEDULE OF DISAGGREGATION OF REVENUE |
The
following table disaggregates the Company’s revenues by major revenue streams:
SCHEDULE
OF DISAGGREGATION OF REVENUE
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Revenue stream: | |
| | | |
| | | |
| | | |
| | |
Cell process development services and hospital services | |
$ | 347 | | |
$ | 110 | | |
$ | 734 | | |
$ | 365 | |
Total | |
$ | 347 | | |
$ | 110 | | |
$ | 734 | | |
$ | 365 | |
|
SCHEDULE OF BREAKDOWN OF REVENUES PER CUSTOMER |
A
breakdown of the revenues per customer constituted at least 10% of revenues is as follows:
SCHEDULE
OF BREAKDOWN OF REVENUES PER CUSTOMER
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | | |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Revenue earned: | |
| | | |
| | | |
| | | |
| | |
Customer A (United States) | |
$ | 265 | | |
$ | - | | |
$ | 265 | | |
$ | 130 | |
Customer B (United States) | |
$ | - | | |
$ | - | | |
$ | 300 | | |
$ | - | |
Revenue earned | |
$ | - | | |
$ | - | | |
$ | 300 | | |
$ | - | |
|
SCHEDULE OF ACTIVITY FOR TRADE RECEIVABLES |
The
activity for trade receivables is comprised of:
SCHEDULE
OF ACTIVITY FOR TRADE RECEIVABLES
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Balance as of beginning of period | |
$ | 88 | | |
$ | 36,183 | |
Reconsolidation (deconsolidation) of Octomera | |
| 82 | | |
| (5,985 | ) |
Additions | |
| 458 | | |
| 403 | |
Collections | |
| (981 | ) | |
| (6,090 | ) |
Allowances for credit losses | |
| 512 | | |
| (24,388 | ) |
Exchange rate differences | |
| 2 | | |
| (52 | ) |
Balance as of end of period | |
$ | 161 | | |
$ | 71 | |
|
SCHEDULE OF ACTIVITY FOR CONTRACT LIABILITIES |
The
activity for contract liabilities is comprised of:
SCHEDULE
OF ACTIVITY FOR CONTRACT LIABILITIES
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
Nine Months Ended | |
| |
September 30, 2024 | | |
September 30, 2023 | |
| |
(in thousands) | |
Balance as of beginning of period | |
$ | 200 | | |
$ | 70 | |
Deconsolidation of Octomera | |
| 110 | | |
| (106 | ) |
Deconsolidation of OBI | |
| (60 | ) | |
| - | |
Deconsolidation | |
| (60 | ) | |
| - | |
Additions | |
| 160 | | |
| 156 | |
Realizations | |
| (279 | ) | |
| - | |
Balance as of end of period | |
$ | 131 | | |
$ | 120 | |
|
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v3.24.3
DESCRIPTION OF BUSINESS (Details Narrative) - USD ($)
|
|
|
|
9 Months Ended |
|
|
|
Sep. 20, 2024 |
May 31, 2024 |
May 21, 2024 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Jan. 29, 2024 |
Dec. 31, 2023 |
Sep. 27, 2023 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Reverse stock split |
1-for-10
reverse stock split
|
|
|
|
|
|
|
|
Common stock, shares authorized |
|
|
|
14,583,333
|
|
|
14,583,333
|
|
Commons stock, par value |
|
|
|
$ 0.0001
|
|
|
$ 0.0001
|
|
Accumulated deficit |
|
|
|
$ 204,411,000
|
|
|
$ 176,622,000
|
|
Net cash used in operating activities |
|
|
|
$ 14,978,000
|
$ 14,335,000
|
|
|
|
Debt Exchange Agreements [Member] | Three Convertible Debt Holders [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Outstanding principal and accrued interest |
|
$ 16,007
|
$ 16,007,000
|
|
|
|
|
|
Number of shares issued |
|
1,577,694
|
1,577,695
|
|
|
|
|
|
Octomera LLC [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Equity method investment, ownership percentage |
|
|
|
|
|
100.00%
|
|
|
ORGS [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Commons stock, par value |
|
|
|
$ 0.0001
|
|
|
|
|
Minimum closing bid price |
|
|
|
|
|
|
|
$ 1.00
|
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v3.24.3
SCHEDULE OF SEGMENT REPORTING (Details) - USD ($) $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Segment Reporting Information [Line Items] |
|
|
|
|
|
Revenues |
|
$ 347
|
$ 110
|
$ 734
|
$ 365
|
Cost of revenues |
[1] |
(437)
|
(134)
|
(1,103)
|
(5,616)
|
Gross profit |
|
(90)
|
(24)
|
(369)
|
(5,251)
|
Cost of development services and research and development expenses |
[1] |
(4,337)
|
(779)
|
(7,922)
|
(7,331)
|
Operating expenses |
[1] |
(2,737)
|
(1,241)
|
(10,966)
|
(32,953)
|
Impairment expenses** |
|
(692)
|
|
(692)
|
|
Loss from deconsolidation of Octomera |
|
|
|
(66)
|
(5,343)
|
Other income |
|
(122)
|
2
|
(114)
|
4
|
Depreciation and amortization |
|
(538)
|
(191)
|
(1,625)
|
(1,366)
|
Loss from extinguishment in connection with convertible loan |
|
|
|
(141)
|
(283)
|
Credit losses on convertible loan receivable |
|
|
|
|
(2,688)
|
Financial (expenses) income, net |
|
(718)
|
(545)
|
(2,385)
|
(1,918)
|
Convertible loans induced conversion expenses |
|
|
|
(4,304)
|
|
Share in net income of associated companies |
|
|
(553)
|
|
(552)
|
Loss before income taxes |
|
(9,234)
|
(3,331)
|
(28,584)
|
(57,681)
|
Octomera [Member] |
|
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
|
Revenues |
|
272
|
29
|
322
|
44
|
Cost of revenues |
[1] |
(245)
|
(1,875)
|
(1,292)
|
(6,959)
|
Gross profit |
|
27
|
(1,846)
|
(970)
|
(6,915)
|
Cost of development services and research and development expenses |
[1] |
(1,291)
|
(2,327)
|
(4,542)
|
(6,828)
|
Operating expenses |
[1] |
(680)
|
(3,931)
|
(1,226)
|
(31,921)
|
Impairment expenses** |
|
|
|
|
|
Loss from deconsolidation of Octomera |
|
|
|
|
|
Other income |
|
(126)
|
|
(126)
|
2
|
Depreciation and amortization |
|
(301)
|
(515)
|
(1,171)
|
(1,294)
|
Loss from extinguishment in connection with convertible loan |
|
|
|
|
|
Credit losses on convertible loan receivable |
|
|
|
|
|
Financial (expenses) income, net |
|
(202)
|
(92)
|
(756)
|
(587)
|
Convertible loans induced conversion expenses |
|
|
|
|
|
Share in net income of associated companies |
|
|
|
|
|
Loss before income taxes |
|
(2,573)
|
(8,711)
|
(8,791)
|
(47,543)
|
Therapies [Member] |
|
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
|
Revenues |
|
75
|
110
|
435
|
350
|
Cost of revenues |
[1] |
(192)
|
(133)
|
(521)
|
(531)
|
Gross profit |
|
(117)
|
(23)
|
(86)
|
(181)
|
Cost of development services and research and development expenses |
[1] |
(3,048)
|
(779)
|
(4,079)
|
(2,830)
|
Operating expenses |
[1] |
(1,975)
|
(1,240)
|
(9,012)
|
(4,962)
|
Impairment expenses** |
|
(692)
|
|
(692)
|
|
Loss from deconsolidation of Octomera |
|
|
|
|
|
Other income |
|
4
|
2
|
12
|
2
|
Depreciation and amortization |
|
(194)
|
(193)
|
(581)
|
(589)
|
Loss from extinguishment in connection with convertible loan |
|
|
|
(141)
|
(283)
|
Credit losses on convertible loan receivable |
|
|
|
|
(2,688)
|
Financial (expenses) income, net |
|
(515)
|
(546)
|
(1,752)
|
(1,425)
|
Convertible loans induced conversion expenses |
|
|
|
(4,304)
|
|
Share in net income of associated companies |
|
|
(11)
|
|
(10)
|
Loss before income taxes |
|
(6,537)
|
(2,790)
|
(20,635)
|
(12,966)
|
Eliminations [Member] |
|
|
|
|
|
Segment Reporting Information [Line Items] |
|
|
|
|
|
Revenues |
|
|
(29)
|
(23)
|
(29)
|
Cost of revenues |
[1] |
|
1,874
|
710
|
1,874
|
Gross profit |
|
|
1,845
|
687
|
1,845
|
Cost of development services and research and development expenses |
[1] |
2
|
2,327
|
699
|
2,327
|
Operating expenses |
[1] |
(82)
|
3,930
|
(728)
|
3,930
|
Impairment expenses** |
|
|
|
|
|
Loss from deconsolidation of Octomera |
|
|
|
(66)
|
(5,343)
|
Other income |
|
|
|
|
|
Depreciation and amortization |
|
(43)
|
517
|
127
|
517
|
Loss from extinguishment in connection with convertible loan |
|
|
|
|
|
Credit losses on convertible loan receivable |
|
|
|
|
|
Financial (expenses) income, net |
|
(1)
|
93
|
123
|
94
|
Convertible loans induced conversion expenses |
|
|
|
|
|
Share in net income of associated companies |
|
|
(542)
|
|
(542)
|
Loss before income taxes |
|
$ (124)
|
$ 8,170
|
$ 842
|
$ 2,828
|
|
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v3.24.3
SCHEDULE OF PURCHASE PRICE TO THE FAIR VALUES OF THE ASSETS ACQUIRED AND LIABILITIES ASSUMED (Details) - Octomera [Member] $ in Thousands |
Sep. 30, 2024
USD ($)
|
Restructuring Cost and Reserve [Line Items] |
|
Total Contingent consideration to MM for royalty and milestone payments |
$ 4,643
|
Total assets acquired: |
|
Cash and cash equivalents |
139
|
Property, plants and equipment, net |
17,852
|
Other Assets |
3,478
|
Total assets |
21,469
|
Total liabilities assumed: |
|
Total current liabilities |
(12,518)
|
Total long-term liabilities |
(5,628)
|
Total liabilities |
(18,146)
|
Know how Technology |
1,728
|
Total Net Assets |
5,051
|
Fair-Value of Non-controlling interests |
(408)
|
Total liability to MM |
$ 4,643
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RECONSOLIDATION OF OCTOMERA LLC (Details Narrative) - USD ($) $ in Thousands |
1 Months Ended |
3 Months Ended |
9 Months Ended |
|
Jan. 29, 2024 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
Net loss |
|
$ (9,120)
|
$ (3,725)
|
$ (27,789)
|
$ (48,738)
|
|
Loss from deconsolidation of OBI and Octomera |
|
|
|
66
|
$ 5,343
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
Derivative Assets (Liabilities), at Fair Value, Net |
$ 4,643
|
4,906
|
|
4,906
|
|
|
Revaluation expense |
|
$ 263
|
|
$ 263
|
|
|
Know How Technology [Member] |
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
Intangible assets useful life |
|
10 years
|
|
10 years
|
|
|
Octomera [Member] |
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
Recognition of intangible asset |
|
$ 1,728
|
|
$ 1,728
|
|
|
Liability to MM |
|
4,643
|
|
4,643
|
|
|
Transaction cost |
|
|
$ 0
|
50
|
|
|
Revenues |
23
|
|
|
|
|
|
Net loss |
$ 1,244
|
|
|
|
|
|
10 Secured Promissory Notes [Member] |
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
Original principal amount |
|
2,600
|
|
2,600
|
|
|
Unit Purchase Agreement [Member] |
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
Milestone payments |
|
|
|
$ 40,000
|
|
|
Milestone sales percentage |
|
|
|
5.00%
|
|
|
Metalmark [Member] | Unit Purchase Agreement [Member] |
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
Royalty percentage to be received |
|
|
|
5.00%
|
|
|
Related Party [Member] |
|
|
|
|
|
|
Defined Benefit Plan Disclosure [Line Items] |
|
|
|
|
|
|
Accounts payable related parties |
|
$ 2,699
|
|
$ 2,699
|
|
$ 133
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v3.24.3
EQUITY (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
|
|
9 Months Ended |
|
|
|
|
|
|
May 10, 2024 |
Mar. 03, 2024 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 05, 2024 |
Jul. 14, 2024 |
May 22, 2024 |
Apr. 23, 2024 |
Apr. 18, 2024 |
Mar. 07, 2024 |
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
Purchase of warrants |
|
|
|
|
|
20,000
|
|
50,000
|
50,000
|
50,000
|
Exercise price of warrants |
|
|
|
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
Gross proceeds from offering |
|
|
$ 2,556
|
$ 4,341
|
|
|
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
Exercise price of warrants |
|
|
$ 10.0
|
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
Gross proceeds from offering |
$ 154
|
|
|
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
Purchase of warrants |
15,000
|
|
|
|
|
|
|
|
|
|
Exercise price of warrants |
$ 15.0
|
|
|
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] | Warrant One [Member] |
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
Purchase of warrants |
15,000
|
|
|
|
|
|
|
|
|
|
Exercise price of warrants |
$ 20.0
|
|
|
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] | Private Placement [Member] |
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
Common stock shares issued and sell |
15,000
|
227,272
|
|
|
|
|
|
|
|
|
Sale of stock, price per share |
$ 10.3
|
$ 10.3
|
|
|
|
|
|
|
|
|
Gross proceeds from offering |
|
$ 2,300
|
|
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] | Private Placement [Member] | Warrant One [Member] |
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
Purchase of warrants |
|
227,272
|
|
|
|
|
|
|
|
|
Exercise price of warrants |
|
$ 20.0
|
|
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] | Private Placement [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
Purchase of warrants |
|
227,272
|
|
|
|
|
|
|
|
|
Exercise price of warrants |
|
$ 15.0
|
|
|
|
|
|
|
|
|
X |
- DefinitionExercise price per share or per unit of warrants or rights outstanding.
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v3.24.3
SCHEDULE OF LONG TERM CONVERTIBLE NOTES (Details) - USD ($) $ / shares in Units, $ in Thousands |
9 Months Ended |
12 Months Ended |
Sep. 30, 2024 |
Dec. 31, 2023 |
Convertible Loans One [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Principal Amount at Issuance |
|
$ 100
|
|
$ 750
|
Issuance Date (Year) |
|
2019
|
|
2018
|
Current Interest Rate |
|
8.00%
|
|
10.00%
|
Current Maturity (Year) |
|
2024
|
|
2026
|
Current Conversion Price of loan into equity |
|
$ 10.3
|
|
$ 25.0
|
Convertible Loans Two [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Principal Amount at Issuance |
|
$ 100
|
|
$ 1,500
|
Issuance Date (Year) |
|
2020
|
|
2019
|
Current Interest Rate |
|
8.00%
|
|
10.00%
|
Current Maturity (Year) |
|
2024
|
|
2026
|
Current Conversion Price of loan into equity |
|
$ 10.3
|
|
$ 25.0
|
Convertible Loans Three [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Principal Amount at Issuance |
|
$ 1,150
|
|
$ 100
|
Issuance Date (Year) |
|
2022
|
|
2019
|
Current Interest Rate |
|
6.00%
|
|
8.00%
|
Current Maturity (Year) |
|
2023
|
[1] |
2024
|
Current Conversion Price of loan into equity |
|
$ 45.0
|
|
$ 70.0
|
Convertible Loans Four [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Principal Amount at Issuance |
|
$ 5,000
|
|
$ 5,000
|
Issuance Date (Year) |
|
2023
|
|
2019
|
Current Interest Rate |
|
8.00%
|
|
10.00%
|
Current Maturity (Year) |
|
2026
|
|
2026
|
Current Conversion Price of loan into equity |
|
$ 24.6
|
|
$ 25.0
|
Convertible Loans [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Principal Amount at Issuance |
|
$ 6,350
|
|
$ 19,335
|
Convertible Loans Five [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Principal Amount at Issuance |
|
|
|
$ 100
|
Issuance Date (Year) |
|
|
|
2020
|
Current Interest Rate |
|
|
|
8.00%
|
Current Maturity (Year) |
|
|
|
2024
|
Current Conversion Price of loan into equity |
|
|
|
$ 70.0
|
Convertible Loans Six [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Principal Amount at Issuance |
|
|
|
$ 5,000
|
Issuance Date (Year) |
|
|
|
2022
|
Current Interest Rate |
|
|
|
10.00%
|
Current Maturity (Year) |
|
|
|
2026
|
Current Conversion Price of loan into equity |
|
|
|
$ 25.0
|
Convertible Loans Seven [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Principal Amount at Issuance |
|
|
|
$ 1,150
|
Issuance Date (Year) |
|
|
|
2022
|
Current Interest Rate |
|
|
|
6.00%
|
Current Maturity (Year) |
[2] |
|
|
2023
|
Current Conversion Price of loan into equity |
|
|
|
$ 45.0
|
Convertible Loans Eight [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Principal Amount at Issuance |
|
|
|
$ 5,000
|
Issuance Date (Year) |
|
|
|
2023
|
Current Interest Rate |
|
|
|
8.00%
|
Current Maturity (Year) |
|
|
|
2026
|
Current Conversion Price of loan into equity |
|
|
|
$ 24.6
|
Convertible Loans Nine [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Principal Amount at Issuance |
|
|
|
$ 735
|
Issuance Date (Year) |
|
|
|
2023
|
Current Interest Rate |
|
|
|
8.00%
|
Current Maturity (Year) |
|
|
|
2024
|
Current Conversion Price of loan into equity |
|
|
|
$ 8.5
|
|
|
X |
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v3.24.3
CONVERTIBLE LOANS (Details Narrative) - USD ($)
|
|
|
|
1 Months Ended |
9 Months Ended |
|
|
|
|
|
|
|
May 31, 2024 |
May 21, 2024 |
Jan. 01, 2024 |
Jan. 31, 2024 |
Sep. 30, 2024 |
Sep. 05, 2024 |
Jul. 14, 2024 |
May 22, 2024 |
Apr. 23, 2024 |
Apr. 18, 2024 |
Mar. 07, 2024 |
Dec. 31, 2023 |
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued |
|
|
|
|
4,799,323
|
|
|
|
|
|
|
3,216,363
|
Number of securities called by warrants or rights |
|
|
|
|
|
|
20,000
|
|
50,000
|
50,000
|
50,000
|
|
Exercise price of warrants |
|
|
|
|
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
|
Debt Exchange Agreements [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Exchange price |
|
|
$ 8.5
|
|
|
|
|
|
|
|
|
|
Debt instrument, maturity date |
|
|
Dec. 31, 2024
|
Dec. 31, 2026
|
|
|
|
|
|
|
|
|
Number of securities called by warrants or rights |
|
|
36,000
|
84,000
|
|
|
|
|
|
|
|
|
Exercise price of warrants |
|
|
$ 8.5
|
$ 8.5
|
|
|
|
|
|
|
|
|
Debt Exchange Agreements [Member] | Three Convertible Debt Holders [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding principal and accrued interest |
$ 16,007
|
$ 16,007,000
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
1,577,694
|
1,577,695
|
|
|
|
|
|
|
|
|
|
|
Common stock issued |
|
|
|
|
1,182,919
|
|
|
|
|
|
|
|
Outstanding principal |
|
|
|
|
$ 14,784,000
|
|
|
|
|
|
|
|
Debt conversion expense |
|
|
|
|
$ 4,304,000
|
|
|
|
|
|
|
|
Debt Exchange Agreements [Member] | Three Convertible Debt Holders [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Exchange price |
|
|
|
|
$ 25.0
|
|
|
|
|
|
|
|
Debt Exchange Agreements [Member] | Three Convertible Debt Holders [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
Exchange price |
|
|
|
|
$ 10.3
|
|
|
|
|
|
|
|
X |
- DefinitionExercise price per share or per unit of warrants or rights outstanding.
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- DefinitionContractual interest rate for funds borrowed, under the debt agreement.
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v3.24.3
SCHEDULE OF SHORT TERM LOANS - Parenthetical (Details) - $ / shares
|
|
1 Months Ended |
|
|
|
|
|
|
Jan. 01, 2024 |
Jan. 31, 2024 |
Sep. 05, 2024 |
Jul. 14, 2024 |
May 22, 2024 |
Apr. 23, 2024 |
Apr. 18, 2024 |
Mar. 07, 2024 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Number of securities called by warrants or rights |
|
|
|
20,000
|
|
50,000
|
50,000
|
50,000
|
Exercise price of warrants |
|
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
Debt Exchange Agreements [Member] |
|
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
|
Debt instrument, maturity date |
Dec. 31, 2024
|
Dec. 31, 2026
|
|
|
|
|
|
|
Number of securities called by warrants or rights |
36,000
|
84,000
|
|
|
|
|
|
|
Exercise price of warrants |
$ 8.5
|
$ 8.5
|
|
|
|
|
|
|
Conversion price |
$ 8.5
|
|
|
|
|
|
|
|
X |
- DefinitionExercise price per share or per unit of warrants or rights outstanding.
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v3.24.3
SCHEDULE OF WARRANTS GRANTED (Details) - $ / shares
|
|
|
|
|
|
|
9 Months Ended |
Sep. 05, 2024 |
Jul. 14, 2024 |
May 22, 2024 |
Apr. 23, 2024 |
Apr. 18, 2024 |
Mar. 07, 2024 |
Sep. 30, 2024 |
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
Reason for issuance |
Strategic advisor agreement
|
Strategic advisor agreement
|
Strategic advisor agreement
|
Strategic advisor agreement
|
Strategic advisor agreement
|
Strategic advisor agreement
|
|
Exercise price |
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
|
Warrants and Rights Outstanding, Maturity Date |
|
Jul. 13, 2029
|
May 21, 2029
|
Apr. 22, 2029
|
Apr. 17, 2029
|
Mar. 06, 2029
|
|
Warrant [Member] |
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
Number of warrants |
|
|
|
|
|
|
248,181
|
Exercise price |
|
|
|
|
|
|
$ 10.0
|
April 07, 2024 [Member] | Warrant [Member] |
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
Date of issuance |
|
|
|
|
|
|
Apr. 07, 2024
|
Reason for issuance |
|
|
|
|
|
|
Loan Agreement
|
Number of warrants |
|
|
|
|
|
|
15,625
|
Exercise price |
|
|
|
|
|
|
$ 8
|
Warrant vesting subject to continued service provided to Company |
|
|
|
|
|
|
Immediate
|
Warrants and Rights Outstanding, Maturity Date |
|
|
|
|
|
|
Oct. 06, 2024
|
April 05 2024 [Member] | Warrant [Member] |
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
Date of issuance |
|
|
|
|
|
|
Apr. 05, 2024
|
Reason for issuance |
|
|
|
|
|
|
Loan Agreement
|
Number of warrants |
|
|
|
|
|
|
21,875
|
Exercise price |
|
|
|
|
|
|
$ 8
|
Warrant vesting subject to continued service provided to Company |
|
|
|
|
|
|
Immediate
|
Warrants and Rights Outstanding, Maturity Date |
|
|
|
|
|
|
Oct. 04, 2024
|
August 21 2024 [Member] | Warrant [Member] |
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
Date of issuance |
|
|
|
|
|
|
Aug. 21, 2024
|
Reason for issuance |
|
|
|
|
|
|
Loan Agreement
|
Number of warrants |
|
|
|
|
|
|
24,272
|
Exercise price |
|
|
|
|
|
|
$ 10.3
|
Warrant vesting subject to continued service provided to Company |
|
|
|
|
|
|
Immediate
|
Warrants and Rights Outstanding, Maturity Date |
|
|
|
|
|
|
Aug. 20, 2029
|
August 21 2024 One [Member] | Warrant [Member] |
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
Date of issuance |
|
|
|
|
|
|
Aug. 21, 2024
|
Reason for issuance |
|
|
|
|
|
|
Loan Agreement
|
Number of warrants |
|
|
|
|
|
|
97,088
|
Exercise price |
|
|
|
|
|
|
$ 10.3
|
Warrant vesting subject to continued service provided to Company |
|
|
|
|
|
|
Immediate
|
Warrants and Rights Outstanding, Maturity Date |
|
|
|
|
|
|
Aug. 20, 2029
|
September 06 2024 [Member] | Warrant [Member] |
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
Date of issuance |
|
|
|
|
|
|
Sep. 06, 2024
|
Reason for issuance |
|
|
|
|
|
|
Loan Agreement
|
Number of warrants |
|
|
|
|
|
|
24,272
|
Exercise price |
|
|
|
|
|
|
$ 10.3
|
Warrant vesting subject to continued service provided to Company |
|
|
|
|
|
|
Immediate
|
Warrants and Rights Outstanding, Maturity Date |
|
|
|
|
|
|
Sep. 05, 2025
|
September 10 2024 [Member] | Warrant [Member] |
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
Date of issuance |
|
|
|
|
|
|
Sep. 10, 2024
|
Reason for issuance |
|
|
|
|
|
|
Loan Agreement
|
Number of warrants |
|
|
|
|
|
|
1,942
|
Exercise price |
|
|
|
|
|
|
$ 10.3
|
Warrant vesting subject to continued service provided to Company |
|
|
|
|
|
|
Immediate
|
Warrants and Rights Outstanding, Maturity Date |
|
|
|
|
|
|
Sep. 09, 2025
|
September 09 2024 [Member] | Warrant [Member] |
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
Date of issuance |
|
|
|
|
|
|
Sep. 09, 2024
|
Reason for issuance |
|
|
|
|
|
|
Loan Agreement
|
Number of warrants |
|
|
|
|
|
|
24,272
|
Exercise price |
|
|
|
|
|
|
$ 10.3
|
Warrant vesting subject to continued service provided to Company |
|
|
|
|
|
|
Immediate
|
Warrants and Rights Outstanding, Maturity Date |
|
|
|
|
|
|
Sep. 08, 2029
|
September 17 2024 [Member] | Warrant [Member] |
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
Date of issuance |
|
|
|
|
|
|
Sep. 17, 2024
|
Reason for issuance |
|
|
|
|
|
|
Loan Agreement
|
Number of warrants |
|
|
|
|
|
|
24,272
|
Exercise price |
|
|
|
|
|
|
$ 10.3
|
Warrant vesting subject to continued service provided to Company |
|
|
|
|
|
|
Immediate
|
Warrants and Rights Outstanding, Maturity Date |
|
|
|
|
|
|
Sep. 16, 2029
|
September 30 2024 [Member] | Warrant [Member] |
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
Date of issuance |
|
|
|
|
|
|
Sep. 30, 2024
|
Reason for issuance |
|
|
|
|
|
|
Loan Agreement
|
Number of warrants |
|
|
|
|
|
|
14,563
|
Exercise price |
|
|
|
|
|
|
$ 10.3
|
Warrant vesting subject to continued service provided to Company |
|
|
|
|
|
|
Immediate
|
Warrants and Rights Outstanding, Maturity Date |
|
|
|
|
|
|
Sep. 29, 2025
|
X |
- DefinitionWarrant vesting period description.
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v3.24.3
LOANS (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
1 Months Ended |
|
|
|
|
|
Oct. 31, 2024 |
Jul. 14, 2024 |
Apr. 23, 2024 |
Apr. 18, 2024 |
Mar. 07, 2024 |
Mar. 31, 2018 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Purchase of warrants |
|
20,000
|
50,000
|
50,000
|
50,000
|
|
Common Stock [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Outstanding principal and accrued interest |
|
|
|
|
|
$ 383
|
Loan Agreement [Member] | Subsequent Event [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Outstanding principal and accrued interest |
$ 790
|
|
|
|
|
|
Interest rate |
10.00%
|
|
|
|
|
|
Sale of stock, price per share |
$ 1.03
|
|
|
|
|
|
Loan Agreement [Member] | Subsequent Event [Member] | Common Stock [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Purchase of warrants |
767,089
|
|
|
|
|
|
Sale of stock, price per share |
$ 1.03
|
|
|
|
|
|
Loan Agreement [Member] | Subsequent Event [Member] | Warrant [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Purchase of warrants |
526,187
|
|
|
|
|
|
Short term loan amount |
$ 2,300
|
|
|
|
|
|
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v3.24.3
SCHEDULE OF EMPLOYEE STOCK OWNERSHIP PLAN DISCLOSURES (Details) $ / shares in Units, $ in Thousands |
9 Months Ended |
Sep. 30, 2024
USD ($)
$ / shares
shares
|
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] |
|
Fair value at grant | $ |
$ 350
|
Employees [Member] |
|
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] |
|
Stock options vesting period description |
5,000 Immediate and 3,250 quarterly over a period of two years
|
Options Granted To Employees [Member] | Employees [Member] |
|
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] |
|
No of options granted | shares |
126,912
|
Stock options vesting period description |
41,100 quarterly over a period of two years, 20,000 quarterly over a period of four years, 1,250 annually over a period of three years and 64,563 immediate
|
Fair value at grant | $ |
$ 655
|
Expiration period |
10 years
|
Options Granted To Employees [Member] | Employees [Member] | Minimum [Member] |
|
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] |
|
Exercise price | $ / shares |
$ 5.0
|
Options Granted To Employees [Member] | Employees [Member] | Maximum [Member] |
|
Employee Stock Ownership Plan (ESOP) Disclosures [Line Items] |
|
Exercise price | $ / shares |
$ 10.3
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v3.24.3
SCHEDULE OF SHARES AND WARRANTS GRANTS TO ADVISORS (Details) - USD ($) $ / shares in Units, $ in Thousands |
|
|
|
|
|
|
9 Months Ended |
Sep. 05, 2024 |
Jul. 14, 2024 |
May 22, 2024 |
Apr. 23, 2024 |
Apr. 18, 2024 |
Mar. 07, 2024 |
Sep. 30, 2024 |
Reason for issue of share or warrant |
Strategic advisor agreement
|
Strategic advisor agreement
|
Strategic advisor agreement
|
Strategic advisor agreement
|
Strategic advisor agreement
|
Strategic advisor agreement
|
|
Number of shares issued |
50,000
|
|
47,500
|
|
|
50,000
|
|
Warrants to purchase common stock |
|
20,000
|
|
50,000
|
50,000
|
50,000
|
|
Exercise price of warrants |
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
|
Warrant vesting |
|
One third on July 14, 2024, one third on October 14, 2024, and one third on January 14, 2024.
|
One third on May 21, 2024, one third on August 21, 2024, and one third on November 21, 2024.
|
One third on April 16, 2024, one third on July 16, 2024, and one third on October 16, 2024.
|
One third on April 18, 2024, one third on July 18, 2024, and one third on October 18, 2024.
|
One third on March 7, 2024, one third on June 5, 2024, and one third on September 3, 2024.
|
|
Warrant expiry date |
|
Jul. 13, 2029
|
May 21, 2029
|
Apr. 22, 2029
|
Apr. 17, 2029
|
Mar. 06, 2029
|
|
Fair value at grant |
|
|
|
|
|
|
$ 350
|
Number of shares granted |
|
|
|
|
|
|
50,000
|
Warrant [Member] |
|
|
|
|
|
|
|
Exercise price of warrants |
|
|
|
|
|
|
$ 10.0
|
Number of options granted |
|
|
|
|
|
|
217,500
|
Restricted stock unit vesting period description |
|
|
|
|
|
|
Over a period of nine months
|
Fair value at grant |
|
|
|
|
|
|
$ 646
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v3.24.3
SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Earnings Per Share [Abstract] |
|
|
|
|
Net loss attributable to Orgenesis Inc. |
$ 9,120
|
$ 3,725
|
$ 27,789
|
$ 48,738
|
Weighted average number of common shares outstanding - basic |
4,715,229
|
3,002,259
|
3,938,419
|
2,868,078
|
Weighted average number of common shares outstanding - diluted |
4,715,229
|
3,002,259
|
3,938,419
|
2,868,078
|
Net loss per share - basic |
$ 1.93
|
$ 0.12
|
$ 7.06
|
$ 1.70
|
Net loss per share - diluted |
$ 1.93
|
$ 0.12
|
$ 7.06
|
$ 1.70
|
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LOSS PER SHARE (Details Narrative) - shares
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Options and Warrants [Member] |
|
|
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
|
|
Antidilutive securities excluded from computation of earnings per share amount |
1,825,724
|
796,348
|
1,613,665
|
768,004
|
Shares upon Conversion of Convertible Loans [Member] |
|
|
|
|
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721,335
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v3.24.3
OTHER SIGNIFICANT TRANSACTIONS AND AGREEMENTS DURING THE NINE MONTHS ENDED SEPTEMBER 30, 2024 (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands |
Aug. 09, 2024 |
Jul. 12, 2024 |
Apr. 05, 2024 |
Sep. 30, 2024 |
Jul. 10, 2024 |
Aggregate purchase price payable by Germfree |
|
|
$ 8,340
|
|
|
Advance payments from Germfree |
|
|
|
$ 6,720
|
|
Strategic Partnership Agreement [Member] |
|
|
|
|
|
Sale of stock description |
Pursuant to the Agreement, any new joint venture entity to be formed (the “JV”)
will initially be owned 49% by the Company and 51% by HSHG. Thereafter, ownership of the JV entity will be based on each party’s
respective contributions, and control of the board of the JV entity will be based upon such percentage contributions. Until the parties
mutually agree to form the new JV entity, HSHG and the Company shall each carry out the respective tasks assigned to them for the implementation
of the project in accordance with the Agreement and the applicable work plan thereunder
|
|
|
|
|
Material Definitive Agreement [Member] |
|
|
|
|
|
Sale of stock description |
(i) $10.3 per share (subject to adjustment for stock splits, consolidations and similar transactions)
or (ii) a 5% premium to the Nasdaq official closing price of the common stock of the Company at the time of HSHG’s investment.
Upon receipt by the Company of the $5,000 investment set forth above, HSHG will receive 485,437 three-year warrants to purchase 485,437
shares of the Company’s common stock at an exercise price equal to the greater of (i) $10.3 per share (subject to adjustment for
stock splits, consolidations and similar transactions) or (ii) a 10% premium to the Nasdaq official closing price of the Company’s
common stock. In addition, HSHG will have the option to provide up to $5,000 of additional funding for phase II, to be invested by December
31, 2025 in the Company’s shares of common stock under the same terms (the “Option”).
|
|
|
|
|
Material Definitive Agreement [Member] | Phase One [Member] |
|
|
|
|
|
Sale of stock price per share |
$ 10.3
|
|
|
|
|
Sale of stock percentage |
5.00%
|
|
|
|
|
Material Definitive Agreement [Member] | Phase Two [Member] |
|
|
|
|
|
Sale of stock price per share |
$ 10.3
|
|
|
|
|
Sale of stock percentage |
10.00%
|
|
|
|
|
Sale of stock investment amount |
$ 5,000
|
|
|
|
|
Number of warrants issued |
485,437
|
|
|
|
|
Broaden [Member] |
|
|
|
|
|
Intangiable asset purchase price valued by third party |
|
|
|
|
$ 11,000
|
Intangiable asset purchase price valued by third party |
|
|
|
|
$ 10,767
|
Share price |
|
|
|
|
$ 30.0
|
Common stock issue price |
|
|
|
|
10.00%
|
Theracell [Member] |
|
|
|
|
|
Intangiable asset purchase price valued by third party |
|
$ 10,324
|
|
|
|
Description of ownership percentage |
|
50%
of the outstanding ownership rights and equity interests in Theracell Laboratories IKE (“Theracell IKE”) not currently
owned by the Company so that the Company shall own 100% of the outstanding equity interests of Theracell IKE; and
|
|
|
|
Intangible asset purchase price valued by third party |
|
$ 13,000
|
|
|
|
[custom:PaymentDescriptionAsPerAgreement] |
|
The
aggregate Consideration will be paid by the Company as follows: (i) $400 will be paid to Theracell within 60 days after signing of the
Purchase Agreement, (ii) $250 will be paid to Theracell within one year after signing of the Purchase Agreement, and (iii) the remaining
amount (less any Debt) will be paid to Theracell in four equal annual payments beginning on December 30, 2025 and ending on December
30, 2028. As of the date of this quarterly report on Form 10-Q, the Company had paid Theracell $243. The Company accounted for the Purchase
agreement by recording the difference between the Consideration and Debt as research and development expenses, and the consideration
that exceeds the debt was recorded in short term or other long-term liabilities as appropriate.
|
|
|
|
Theracell [Member] | Phase One [Member] |
|
|
|
|
|
Intangible asset purchase price valued by third party |
|
$ 5,000
|
|
|
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v3.24.3
LEGAL PROCEEDINGS (Details Narrative) $ / shares in Units, $ in Thousands |
|
|
|
|
1 Months Ended |
|
|
|
|
|
|
|
|
|
|
Jul. 11, 2024
USD ($)
|
Jul. 11, 2024
ILS (₪)
|
Nov. 01, 2023
ILS (₪)
|
Oct. 26, 2023
USD ($)
|
Jan. 18, 2022
ILS (₪)
|
Nov. 30, 2024
USD ($)
|
Sep. 05, 2024
$ / shares
|
Jul. 14, 2024
$ / shares
|
May 22, 2024
$ / shares
|
Apr. 23, 2024
$ / shares
|
Apr. 18, 2024
$ / shares
|
Mar. 07, 2024
$ / shares
|
Nov. 01, 2023
USD ($)
$ / shares
shares
|
Nov. 01, 2023
ILS (₪)
shares
|
Sep. 06, 2023
USD ($)
|
Apr. 30, 2018
shares
|
Mar. 31, 2018
USD ($)
|
Proceedings actions taken by plaintiff description |
|
|
|
|
In the Complaint, the
plaintiffs are seeking that the Court issue a declaratory remedy whereby the defendants are required to pay royalties to the plaintiffs
at the rate of 7% of the sales and 24% of any and all revenues in consideration for sublicenses related to any product, service or process
that contain know-how and technology of Sheba and any and all know-how and technology either developed or supervised by Prof. Ferber
in the field of cell therapy, including in the category of the point-of-care platform and any and all services and products in relation
to the defendants’ CDMO activity
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss contingency, damages paid, value | ₪ |
|
|
|
|
₪ 10,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Royalty guarantee commitments amount |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 896
|
|
|
Plaintiffs request damages amount | ₪ |
|
|
₪ 40,140
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price of warrants | $ / shares |
|
|
|
|
|
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
$ 10.3
|
|
|
|
|
|
Issuance of shares | shares |
|
|
|
|
|
|
|
|
|
|
|
|
1,186,960
|
1,186,960
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 383
|
Issuance of shares | shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,798
|
|
Unsecured Convertible Note Agreements [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unsecured convertible debt |
|
|
|
|
|
|
|
|
|
|
|
|
$ 280
|
₪ 1,000,000
|
|
|
|
Monthly interest rate |
|
|
|
|
|
|
|
|
|
|
|
|
2.00%
|
2.00%
|
|
|
|
Litigation settlement, amount awarded from other party | ₪ |
|
₪ 427,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain loss related to litigation settlement |
$ 114
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional amount to be paid for failure litigation settlement amount awarded from other party | ₪ |
|
₪ 211,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unsecured Convertible Note Agreements [Member] | Subsequent Event [Member] |
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Gain loss related to litigation settlement |
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$ 12
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Consultation Agreement [Member] |
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Warrants awarded | shares |
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80,000
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80,000
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Exercise price of warrants | $ / shares |
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$ 5.2
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Unsecured Convertible Note Two Agreements [Member] |
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Gain loss related to litigation settlement |
$ 57
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Mr Amir Hasidim [Member] |
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Unsecured convertible debt |
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$ 5,000
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Southern Israel Bridging Fund Two LP [Member] | Mr Amir Hasidim [Member] |
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Plaintiffs request damages amount |
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$ 1,150
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Litigation settlement interest percentage |
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6.00%
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Orgenesis (NASDAQ:ORGS)
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