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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 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 June 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: 001-36581
Notable
Labs, Ltd.
(Exact
name of registrant as specified in its charter)
Israel |
|
Not
Applicable |
(State
or other jurisdiction of |
|
(I.R.S.
Employer |
incorporation
or organization) |
|
Identification
No.) |
320
Hatch Drive |
|
|
Foster
City, California |
|
94404 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (415) 851-2410
(Former
name, former address, and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Ordinary
Shares, par value NIS 0.35 per share |
|
NTBL |
|
The
Nasdaq Capital Market |
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 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 any 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 August 14, 2024, the registrant had 9,659,496 ordinary shares, par value NIS 0.35 par value per share, outstanding.
NOTABLE
LABS, LTD.
Table
of Contents
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q contains forward-looking statements that relate to future events or our future financial performance, which
express the current beliefs and expectations of our management. Such statements involve a number of known and unknown risks, uncertainties
and other factors that could cause our actual future results, performance or achievements to differ materially from any future results,
performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements include all statements
that are not historical facts and can be identified by words such as, but not limited to, “believe,” “expect,”
“anticipate,” “estimate,” “intend,” “plan,” “targets,” “likely,”
“will,” “would,” “could,” and similar expressions or phrases. We have based these forward-looking
statements largely on our management’s current expectations and future events and financial trends that we believe may affect our
financial condition, results of operations, business strategy and financial needs. Forward-looking statements include, but are not limited
to, express or implied statements about:
● |
our
cash runway; |
|
|
● |
the
initiation, timing, progress and results of our preclinical and clinical activities, including a Phase 2a trial for Volasertib and
our research and development program; |
|
|
● |
our
expectations about the availability and timing of data from any clinical trial; |
|
|
● |
our
ability to advance product candidates into, and successfully complete, clinical trials; |
|
|
● |
our
plans for future clinical trials; |
|
|
● |
our
ability to manufacture our product candidates in sufficient quantities for clinical trials and, if appropriate, commercialization; |
|
|
● |
the
timing or likelihood of regulatory filings and approvals, including data required to file for regulatory approval; |
|
|
● |
the
commercialization of our product candidates, if approved; |
|
|
● |
potential
advantages of our product candidates; |
|
|
● |
the
pricing and reimbursement of our product candidates, if approved; |
|
|
● |
our
ability to develop and commercialize additional product candidates; |
|
|
● |
our
business strategy; |
|
|
● |
the
implementation of our business model, strategic plans for our business, product candidates and technology; |
|
|
● |
the
scope and duration of protection we are able to establish and maintain for intellectual property rights covering our product candidates
and technology; |
|
|
● |
estimates
of our expenses, future revenues, capital requirements and our needs for additional financing; |
|
|
● |
our
ability to maintain the listing of our ordinary shares on the NASDAQ Capital Market; |
|
|
● |
our
ability to establish and maintain collaborations and the benefits of such collaborations; |
|
|
● |
our
ability to maintain our level of grant funding or obtain additional grant or other non-dilutive sources of funding and commitments
associated with such grants; and |
|
|
● |
developments
relating to our competitors and our industry. |
All
forward-looking statements involve risks, assumptions and uncertainties. You should not rely upon forward-looking statements as predictors
of future events. These forward-looking statements are subject to a number of known and unknown risks, uncertainties and assumptions,
including risks described in the section titled “Risk Factors” contained in our Annual Report on Form 10-K for the year ended
December 31, 2023, filed with the Securities and Exchange Commission, or SEC, on April 11, 2024, and other subsequent filings with the
SEC, including, among other things, the following:
● |
We
have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable
future. |
|
|
● |
We
have never generated any revenue from product sales and may never be profitable. |
|
|
● |
We
will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary
capital when needed may force us to delay, limit or terminate our product development efforts or other operations. |
|
|
● |
We
are highly dependent on our technology in general, and we cannot be certain that our product candidates will receive regulatory approval
or be commercialized or that we will be able to realize any value from these product candidates. Any failure to successfully develop,
obtain regulatory approval for and commercialize any current or future product candidates, independently or in cooperation with a
third-party collaborator, or the experience of significant delays in doing so, would compromise our ability to generate revenue and
become profitable. |
|
|
● |
Our
product candidates are based on novel technology and are in early stages of development, which makes it difficult to predict the
time and cost of development and potential regulatory approval. |
|
|
● |
We
may find it difficult to enroll patients in future clinical trials, and patients could discontinue their participation in our clinical
trials, which could delay or prevent clinical trials of our product candidate. |
|
|
● |
We
may encounter substantial delays in our clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of
applicable regulatory authorities. |
|
|
● |
The
results from our future clinical trials may not be sufficiently robust to support the submission for marketing approval for our product
candidates. Before we submit our product candidates for marketing approval, the U.S. Food and Drug Administration, or FDA, and the
European Medicines Agency, or EMA, may require us to conduct additional clinical trials, or evaluate subjects for an additional follow-up
period. |
|
|
● |
Legislative
and regulatory activity may exert downward pressure on potential pricing and reimbursement for our product candidates, if approved,
that could materially affect the opportunity to commercialize. |
|
|
● |
We
expect to rely on third parties to conduct certain aspects of our product manufacturing, protocol development, research and preclinical
and clinical testing, and these third parties may not perform satisfactorily. |
|
|
● |
We
intend to rely on third-party manufacturers to produce commercial quantities of any of our product candidates that receive regulatory
approval, but we have not entered into binding agreements with any such manufacturers to support commercialization. Additionally,
these manufacturers may not have experience producing our product candidates at commercial levels and may not pass regulatory inspections
or achieve the necessary regulatory approvals or produce our product candidate at the quality, quantities, locations and timing needed
to support commercialization. |
|
|
● |
Our
future success depends on our ability to retain key employees, consultants, and advisors and to attract, retain and motivate qualified
personnel. |
|
|
● |
We
are not in compliance with Nasdaq’s minimum bid price requirement and if we fail to regain compliance our ordinary shares would
be delisted, which could adversely affect the liquidity of our ordinary shares and our ability to raise additional capital. |
|
|
● |
The
market price of our ordinary shares may be highly volatile, and you may not be able to resell your shares at the purchase price. |
These
risks, assumptions and uncertainties are not necessarily all of the important factors that could cause actual results to differ materially
from those expressed in any of our forward-looking statements. Other unknown or unpredictable factors also could harm our results.
All
of the forward-looking statements we have included in this Quarterly Report are based on information available to us on the date of this
Quarterly Report. We undertake no obligation, and specifically decline any obligation, to update publicly or revise any forward-looking
statements, whether as a result of new information, future events or otherwise, after the date of this report. In light of these risks,
uncertainties and assumptions, the forward-looking events discussed in this Quarterly Report might not occur.
PART
I—FINANCIAL INFORMATION
Item
1. Financial Statements.
NOTABLE
LABS, LTD.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(U.S.
dollars in thousands, except share and per share amounts)
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
(Unaudited) | | |
| |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 4,092 | | |
$ | 11,825 | |
Prepaid expenses and other current assets | |
| 2,892 | | |
| 3,645 | |
Total current assets | |
| 6,984 | | |
| 15,470 | |
| |
| | | |
| | |
Property and equipment, net | |
| 346 | | |
| 316 | |
Finance lease right-of-use assets, net | |
| 297 | | |
| 337 | |
Operating lease right-of-use assets | |
| 1,467 | | |
| 1,694 | |
Investment in SAFE | |
| - | | |
| 1,500 | |
Investment in Series Seed Preferred Stock | |
| 1,500 | | |
| - | |
Deferred financing costs | |
| 306 | | |
| - | |
Other assets | |
| 104 | | |
| 224 | |
Total assets | |
$ | 11,004 | | |
$ | 19,541 | |
| |
| | | |
| | |
Liabilities and shareholders’ equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 1,140 | | |
$ | 1,755 | |
Accrued expenses and other current liabilities | |
| 809 | | |
| 418 | |
Accounts payable and accrued expenses - related party | |
| 22 | | |
| 42 | |
Finance lease liabilities, current | |
| 79 | | |
| 78 | |
Operating lease liabilities, current | |
| 467 | | |
| 445 | |
Total current liabilities | |
| 2,517 | | |
| 2,738 | |
| |
| | | |
| | |
Finance lease liabilities, net of current amount | |
| 224 | | |
| 263 | |
Operating lease liabilities, net of current amount | |
| 1,025 | | |
| 1,263 | |
Warrant liability | |
| 52 | | |
| 163 | |
Total liabilities | |
| 3,818 | | |
| 4,427 | |
| |
| | | |
| | |
Commitments and contingencies | |
| - | | |
| - | |
| |
| | | |
| | |
Shareholders’ equity | |
| | | |
| | |
Ordinary shares, NIS 0.35 par value, 34,285,714 shares authorized as of June 30, 2024 and December 31, 2023 and 9,659,496 issued and outstanding as of June 30, 2024 and 9,018,261 issued and outstanding as of December 31, 2023 | |
| 849 | | |
| 788 | |
Additional paid-in capital | |
| 97,514 | | |
| 96,524 | |
Accumulated deficit | |
| (91,293 | ) | |
| (82,308 | ) |
Accumulated other comprehensive income | |
| 116 | | |
| 110 | |
Total shareholders’ equity | |
| 7,186 | | |
| 15,114 | |
Total liabilities and shareholders’ equity | |
$ | 11,004 | | |
$ | 19,541 | |
The
accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
NOTABLE
LABS, LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(U.S.
dollars in thousands, except share and per share amounts)
(Unaudited)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
For the Three Months Ended | | |
For the Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Services revenue | |
$ | 2 | | |
$ | - | | |
$ | 3 | | |
$ | - | |
Cost of services | |
| - | | |
| - | | |
| - | | |
| - | |
Gross profit | |
| 2 | | |
| - | | |
| 3 | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 2,354 | | |
| 1,054 | | |
| 3,904 | | |
| 2,650 | |
General and administrative | |
| 3,028 | | |
| 1,932 | | |
| 5,317 | | |
| 5,855 | |
Total operating expenses | |
| 5,382 | | |
| 2,986 | | |
| 9,221 | | |
| 8,505 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (5,380 | ) | |
| (2,986 | ) | |
| (9,218 | ) | |
| (8,505 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense), net | |
| | | |
| | | |
| | | |
| | |
Change in fair value of SAFEs | |
| - | | |
| (858 | ) | |
| - | | |
| (2,723 | ) |
Change in fair value of warrant liability | |
| 100 | | |
| 408 | | |
| 111 | | |
| 1,504 | |
Other income | |
| 61 | | |
| 1 | | |
| 122 | | |
| 17 | |
Total Other income (expense) | |
| 161 | | |
| (449 | ) | |
| 233 | | |
| (1,202 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
| (5,219 | ) | |
| (3,435 | ) | |
| (8,985 | ) | |
| (9,707 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other comprehensive income (expense) | |
| | | |
| | | |
| | | |
| | |
Change in foreign currency translation adjustment | |
| (59 | ) | |
| - | | |
| 6 | | |
| - | |
| |
| | | |
| | | |
| | | |
| | |
Comprehensive loss | |
$ | (5,278 | ) | |
$ | (3,435 | ) | |
$ | (8,979 | ) | |
$ | (9,707 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss per share, basic and diluted | |
$ | (0.55 | ) | |
$ | (3.54 | ) | |
$ | (0.97 | ) | |
$ | (10.00 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted-average common shares outstanding, basic and diluted | |
| 9,455,751 | | |
| 970,402 | | |
| 9,235,006 | | |
| 970,297 | |
The
accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
NOTABLE
LABS, LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND SHAREHOLDERS’ EQUITY (DEFICIT)
(U.S.
dollars in thousands, except share amounts)
(Unaudited)
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Income | | |
Equity | |
| |
Ordinary | | |
Additional | | |
| | |
Accumulated Other | | |
Total | |
| |
Shares | | |
Paid-In | | |
Accumulated | | |
Comprehensive | | |
Shareholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Income | | |
Equity | |
Balance December 31, 2023 | - |
| 9,018,261 | | |
$ | 788 | | - |
$ | 96,524 | | |
$ | (82,308 | ) | |
$ | 110 | | |
$ | 15,114 | |
Share-based compensation expense | |
| - | | |
| - | | |
| 132 | | |
| - | | |
| - | | |
| 132 | |
Net (loss) income | - |
| - | | |
| - | | - |
| - | | |
| (3,766 | ) | |
| 65 | | |
| (3,701 | ) |
Balance March 31, 2024 | - |
| 9,018,261 | | |
| 788 | | - |
| 96,656 | | |
| (86,074 | ) | |
| 175 | | |
| 11,545 | |
Issuance of restricted share awards | |
| 656,235 | | |
| 62 | | |
| 719 | | |
| - | | |
| - | | |
| 781 | |
Cancellation of restricted share awards | |
| (15,000 | ) | |
| (1 | ) | |
| (17 | ) | |
| - | | |
| - | | |
| (18 | ) |
Share-based compensation expense | |
| - | | |
| - | | |
| 156 | | |
| - | | |
| - | | |
| 156 | |
Net loss | - |
| - | | |
| - | | - |
| - | | |
| (5,219 | ) | |
| (59 | ) | |
| (5,278 | ) |
Balance June 30, 2024 | - |
| 9,659,496 | | |
$ | 849 | | - |
$ | 97,514 | | |
$ | (91,293 | ) | |
$ | 116 | | |
$ | 7,186 | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Income | | |
Deficit | |
| |
Redeemable Convertible | | |
Common | | |
Additional | | |
| | |
Accumulated Other | | |
Total | |
| |
Preferred Stock | | |
Stock | | |
Paid-In | | |
Accumulated | | |
Comprehensive | | |
Shareholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Income | | |
Deficit | |
Balance December 31, 2022 | |
| 464,321 | | |
$ | 35,352 | | |
| 970,192 | | |
$ | 15 | | |
$ | 34,061 | | |
$ | (71,044 | ) | |
$ | - | | |
$ | (36,968 | ) |
Share-based compensation expense | |
| - | | |
| - | | |
| - | | |
| - | | |
| 116 | | |
| - | | |
| - | | |
| 116 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (6,272 | ) | |
| - | | |
| (6,272 | ) |
Balance March 31, 2023 | |
| 464,321 | | |
| 35,352 | | |
| 970,192 | | |
| 15 | | |
| 34,177 | | |
| (77,316 | ) | |
| - | | |
| (43,124 | ) |
Balance | |
| 464,321 | | |
| 35,352 | | |
| 970,192 | | |
| 15 | | |
| 34,177 | | |
| (77,316 | ) | |
| - | | |
| (43,124 | ) |
Exercise of ordinary share options | |
| - | | |
| - | | |
| 315 | | |
| - | | |
| 5 | | |
| - | | |
| - | | |
| 5 | |
Share-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 202 | | |
| - | | |
| - | | |
| 202 | |
Share-based compensation expense | |
| - | | |
| - | | |
| - | | |
| - | | |
| 202 | | |
| - | | |
| - | | |
| 202 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,435 | ) | |
| - | | |
| (3,435 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Balance June 30, 2023 | |
| 464,321 | | |
$ | 35,352 | | |
| 970,507 | | |
$ | 15 | | |
$ | 34,384 | | |
$ | (80,751 | ) | |
$ | - | | |
$ | (46,352 | ) |
Balance | |
| 464,321 | | |
$ | 35,352 | | |
| 970,507 | | |
$ | 15 | | |
$ | 34,384 | | |
$ | (80,751 | ) | |
$ | - | | |
$ | (46,352 | ) |
The
accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
NOTABLE
LABS, LTD.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S.
dollars in thousands)
(Unaudited)
| |
2024 | | |
2023 | |
| |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES | |
| | | |
| | |
Net loss | |
$ | (8,985 | ) | |
$ | (9,707 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation | |
| 127 | | |
| 130 | |
Share-based compensation | |
| 1,051 | | |
| 318 | |
Non-cash operating leases | |
| 227 | | |
| 371 | |
Change in fair value of SAFEs | |
| - | | |
| 2,723 | |
Change in fair value of warrant liability | |
| (111 | ) | |
| (1,504 | ) |
Change in operating assets and liabilities | |
| | | |
| | |
Prepaid expenses | |
| 855 | | |
| 619 | |
Other assets | |
| 18 | | |
| - | |
Accounts payable | |
| (607 | ) | |
| 1,365 | |
Accrued expenses and other current liabilities | |
| 390 | | |
| 227 | |
Accounts payable - related parties | |
| (20 | ) | |
| - | |
Operating lease liabilities | |
| (216 | ) | |
| (375 | ) |
Net cash used in operating activities | |
| (7,271 | ) | |
| (5,833 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES | |
| | | |
| | |
Purchases of property and equipment | |
| (14 | ) | |
| (30 | ) |
Trademark costs | |
| (1 | ) | |
| - | |
Net cash used in investing activities | |
| (15 | ) | |
| (30 | ) |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES | |
| | | |
| | |
Proceeds from employee options | |
| - | | |
| 5 | |
Repayment of finance lease liabilities | |
| (38 | ) | |
| (25 | ) |
Deferred financing costs | |
| (306 | ) | |
| - | |
Proceeds from issuance of the SAFE agreements | |
| - | | |
| 6,198 | |
Net cash (used in) provided by financing activities | |
| (344 | ) | |
| 6,178 | |
| |
| | | |
| | |
Net increase (decrease) in cash and cash equivalents | |
| (7,630 | ) | |
| 315 | |
Effect of exchange rate changes on cash | |
| (103 | ) | |
| - | |
Cash and cash equivalents at the beginning of the period | |
| 11,825 | | |
| 1,581 | |
Cash and cash equivalents at the end of the period | |
$ | 4,092 | | |
$ | 1,896 | |
| |
| | | |
| | |
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING ACTIVITIES: | |
| | | |
| | |
| |
| | | |
| | |
Issuance of finance lease liability for finance lease right-of-use asset | |
$ | - | | |
$ | 405 | |
| |
| | | |
| | |
Issuance of operating lease liability for operating lease right-of-use asset | |
$ | - | | |
$ | 1,950 | |
The
accompanying notes are an integral part of the unaudited condensed consolidated financial statements.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1 – ORGANIZATION AND DESCRIPTION OF BUSINESS
Notable
Labs, Ltd., previously known as Vascular Biogenics, Ltd., is an Israeli corporation (“Notable”). These consolidated financial
statements include three wholly owned subsidiaries, Notable Labs, Inc. (“Notable US”), VBL, Inc. (“VBL”) and
Notable Therapeutics, Inc. (“Therapeutics”) (together with Notable, the “Company”). All material intercompany
transactions have been eliminated in consolidation.
Notable
US was incorporated as a Delaware corporation in 2014. Initially, Notable US developed its Predictive Medicines Platform (“PMP”)
as a diagnostic tool for physicians for identifying which cancer treatment would be the most effective for an individual patient. Notable
US then broadened its mission and applied its PMP to streamline and accelerate the identification and validation of investigational compounds,
working with multiple biotechnology and pharmaceutical companies under service-based agreements. In 2021, by entering into the Oncoheroes
Agreement and the CicloMed Agreement, Notable US advanced from a purely diagnostic company to an integrated – diagnostic and therapeutic
– platform therapeutics company designing and developing or co-developing predictive medicines.
On
October 16, 2023, pursuant to the Agreement and Plan of Merger, dated February 22, 2023 (the “Merger Agreement”), by and
among Notable Labs, Ltd., Merger Sub, and Notable US, Merger Sub was merged with and into Notable US, with Notable US continuing after
the merger as the surviving entity and a wholly owned subsidiary of Notable Labs, Ltd. (the “Merger”). At the effective time
of the Merger, without any action on the part of any stockholder, each issued and outstanding share of pre-Merger Notable US common stock,
par value $0.001 per share (the “Notable US Common Stock”), including shares underlying pre-Merger Notable US outstanding
equity awards, was converted into the right to receive 0.0629 shares (the “Exchange Ratio”) of Notable Labs, Ltd. ordinary
shares, NIS 0.35 par value per share (the “Company Ordinary Shares” or “Notable Ordinary Shares”). Immediately
following the effective time of the Merger, Notable effected a 1-for-35 reverse stock split of the issued and outstanding Notable Ordinary
Shares (the “Reverse Share Split”).
In
connection with the closing of the Merger, Notable changed its name to Notable Labs, Ltd. and Notable’s Ordinary Shares listed
on The Nasdaq Capital Market, previously trading through the close of business on October 16, 2023 under the trading symbol “VBLT”,
commenced trading on The Nasdaq Capital Market, on a post-Reverse Share Split adjusted basis, under the trading symbol “NTBL”
on October 17, 2023.
Liquidity
and Going Concern Assessment
The
Company has incurred losses and negative cash flows from operations since its inception. As of June 30, 2024 and December 31, 2023, the
Company had an accumulated deficit of approximately $91.3
million and $82.3
million, respectively. As of June 30, 2024, the
Company had cash of $4.1
million and has forecasted cash needs in excess of current
liquidity. These conditions raise substantial doubt about its ability to continue as a going concern within one year after the date that
the consolidated financial statements are issued.
The
Company’s ability to fund its operations will require additional capital, and the Company intends to raise such capital through
the issuance of additional debt or equity, including through licensing or collaboration agreements.
These
plans are intended to mitigate the relevant conditions or events that raise substantial doubt about the Company’s ability to continue
as a going concern; however, as the plans are not entirely within the Company’s control, management has determined it is not probable
they will be effectively implemented.
These
financial statements have been prepared on a going concern basis and do not include any adjustments to the amounts and classification
of assets and liabilities that may be necessary in the event the Company can no longer continue as a going concern.
The
Company is continuing to develop its predictive medicine platform and treatments, which is the primary use of funds for the Company.
Management expects to continue to incur additional substantial losses and negative cash flows from operations in the foreseeable future
as a result of expanded research and development activities until regulatory approval is granted. Regulatory approval is not guaranteed
and may never be obtained.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish these plans and secure
sources of financing and ultimately attain profitable operations. However, if such financing is not approved, does not occur, or alternative
financing is not available at adequate levels or on acceptable terms, or profitable operations are not attained, the Company could be
required to significantly reduce operating expenses and delay, reduce the scope of or eliminate some of its development programs, enter
into a collaboration or other similar arrangement with respect to commercialization rights to any of its product candidates, out license
intellectual property rights to its product candidates and sell unsecured assets, or a combination of the above. Any of these actions
could have a material adverse effect on the Company’s business, results of operations, financial condition and/or its ability to
fund its scheduled obligations on a timely basis or at all. If the Company is unable to obtain adequate capital, it could be forced to
cease operations.
NOTE
2 – BASIS OF PREPARATION OF THE FINANCIAL STATEMENTS
The
accompanying unaudited condensed consolidated financial statements of Notable have been prepared in accordance with accounting principles
generally accepted in the United States (“GAAP”) for interim financial information. Accordingly, they do not include all
of the information and notes required by GAAP for annual financial statements. These unaudited interim condensed consolidated financial
statements should therefore be read in conjunction with the audited consolidated financial statements and notes included in Form 10-K,
filed with the Securities and Exchange Commission on April 11, 2024. In the opinion of management, all adjustments (of a normal recurring
nature) considered necessary for the fair statement of the results for the interim periods presented have been included. Operating results
for the interim period are not necessarily indicative of the results that may be expected for the full year.
Notable
affected a 1-for-35 reverse stock split immediately following the effective time of the Merger. No fractional shares were issued in connection
with the Reverse Share Split. Each shareholder who did not have a number of shares evenly divisible pursuant to the Reverse Share Split
ratio and who would otherwise be entitled to receive a fractional ordinary share was entitled to receive an additional Notable Ordinary
Share. The number of shares on equity related disclosures included in the condensed consolidated financial statements and accompanying
notes, were retroactively adjusted to reflect the effects of the Reverse Share Split and the Exchange Ratio.
NOTE
3 – SIGNIFICANT ACCOUNTING POLICIES
The
accounting policies and calculation methods applied in the preparation of the unaudited condensed consolidated interim financial statements
as of June 30, 2024 are consistent with those applied in the preparation of the annual financial statements as of December 31, 2023 and
for the year then ended.
Revenue
Recognition
The
Company performed certain diagnostics services on a limited basis as an outsourced provider during the three and six months ended June
30, 2024 and 2023, but such activities do not represent its major and ongoing central operations.
The
Company recognizes revenue from diagnostic services in the amount that reflects the consideration that it expects to be entitled as the
Company performs its obligation under a contract with a customer by processing diagnostic tests on laboratory samples and making the
test results available to its customers. Revenue is recorded considering a five-step revenue recognition model that includes identifying
the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating
the transaction price to the performance obligations, and recognizing revenue when, or as, an entity satisfies a performance obligation.
The Company generally has a contract or a purchase order from a customer with the specified required terms, including the number of diagnostic
samples to be performed. The Company has not received any advance payments for which there are any remaining performance obligations.
Accordingly, no deferred revenue is recorded as of June 30, 2024 or December 31, 2023. The Company has not recorded any contract assets
as of June 30, 2024 and December 31, 2023 as the Company has not completed any performance obligations for which it has not been able
to bill its customers.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
An
allowance for expected credit losses is established, as necessary, based on past experience and other factors which, in management’s
judgment, deserve current recognition in estimating bad debts. Such factors include growth and composition of accounts receivable, the
relationship of the allowance for expected credit losses to accounts receivable, and current economic conditions. The determination of
the collectability of amounts due requires the Company to make judgments regarding future events and trends. Allowances for expected
credit losses are determined based on assessing the Company’s portfolio on an individual customer and on an overall basis. This
process consists of a review of historical collection experience, current aging status of the customer account, and the financial condition
of the Company’s customers. Based on a review of these factors, the Company establishes or adjusts the allowance for specific customers
and the accounts receivable portfolio as a whole. At June 30, 2024 and December 31, 2023, an allowance for expected credit losses was
not considered necessary as all accounts receivable were deemed collectible.
Cost
of Services
Cost
of services represents costs directly related to the services performed. Cost of services is primarily comprised of cost of samples and
labor.
Use
of Estimates
The
preparation of the condensed consolidated financial statements in conformity with GAAP generally requires management to make certain
estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and accompanying notes.
The Company regularly evaluates estimates and assumptions related to assets and liabilities, and disclosures of contingent assets and
liabilities at the dates of the condensed consolidated financial statements and the reported amounts of expenses during the reporting
period. Areas where management uses subjective judgments include, but are not limited to, measurement of lease liabilities and right-of-use
assets, impairment of long-lived assets, stock-based compensation, accrued research and development costs, SAFEs and warrant liability
in the accompanying condensed consolidated financial statements. Management bases its estimates on historical experience and on various
other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments
about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially
from these estimates under different assumptions or conditions.
Segments
The
Company operates and manages its business as one reportable operating segment, which is the business of developing predictive medicines
that treat various forms of cancer. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial
information on an aggregate basis for allocating resources and evaluating financial performance. All of the Company’s long-lived
assets are maintained in, and all revenues and losses are attributable to, the United States of America.
Recently
Adopted Accounting Pronouncements
As
of June 30, 2024, there are no recently adopted accounting standards which the Company expects would have a material effect on the Company’s
condensed consolidated financial statements.
Recently
Issued Accounting Pronouncements Not Yet Adopted
As
of June 30, 2024, there are no recently issued accounting standards not yet adopted which the Company expects would have a material effect
on the Company’s condensed consolidated financial statements.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
4 – FAIR VALUE MEASUREMENTS
The
following table sets forth the Company’s financial liabilities that are measured at fair value on a recurring basis by level within
the fair value hierarchy (in thousands):
SCHEDULE
OF FAIR VALUE OF FINANCIAL LIABILITIES ON RECURRING BASIS
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total Fair
Value | |
| |
As of June 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total Fair Value | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | — | | |
$ | — | | |
$ | 52 | | |
$ | 52 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total Fair
Value | |
| |
As of December 31, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total Fair Value | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | — | | |
$ | — | | |
$ | 163 | | |
$ | 163 | |
There
were no transfers between Levels 1, 2, or 3 during the six months ended June 30, 2024 and the year ended December 31, 2023. Additionally,
there were no cash equivalents or marketable securities held as of June 30, 2024 and December 31, 2023.
The
value of the warrants was based on the estimated value of the warrant using the Black-Scholes-Merton model as of June 30, 2024. The following
assumptions were used in determining the fair value of the warrants:
SCHEDULE
OF FAIR VALUE ASSUMPTIONS OF WARRANT
| |
| | |
Risk Free interest rate | |
| 4.3 | % |
Expected life (years) | |
| 7.96 | |
Expected volatility | |
| 168.1 | % |
Annual dividend yield | |
| 0 | % |
Warrants measurement input | |
| 0 | % |
The
following is a summary of the Company’s warrant liability activity for the six months ended June 30, 2024 and 2023 (in thousands):
SCHEDULE
OF WARRANT LIABILITY ACTIVITY
| |
June 30, 2024 | |
Balance as of December 31, 2023 | |
$ | 163 | |
Change in fair value | |
| (111 | ) |
Balance as of June 30, 2024 | |
$ | 52 | |
| |
June 30, 2023 | |
Balance as of December 31, 2022 | |
$ | 5,113 | |
Beginning balance | |
$ | 5,113 | |
Change in fair value | |
| (1,504 | ) |
Balance as of June 30, 2023 | |
$ | 3,609 | |
Ending balance | |
$ | 3,609 | |
The
change in the fair value of the warrant liability resulted from a reduction in the value per warrant based on the fair market valuation
of the warrants as of June 30, 2024. The reduction for the six months ended June 30, 2024 related to the decrease in the price of the
underlying shares and the reduction for the six months ended June 30, 2023 related to the decrease in the value of the underlying shares.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
5 – BALANCE SHEET COMPONENTS
Prepaid
Expenses and Other Current Assets
The
following table presents the components of prepaid expenses and other current assets as of June 30, 2024 and December 31, 2023 (in thousands):
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
June 30, 2024 | | |
December 31, 2023 | |
Accounts receivable | |
$ | 184 | | |
$ | 186 | |
Employee retention credit | |
| 316 | | |
| 572 | |
Prepaid expenses | |
| 2,352 | | |
| 2,857 | |
Prepaid benefits | |
| 34 | | |
| 24 | |
Prepaid clinical expenses | |
| 6 | | |
| 6 | |
Total prepaid expenses and other current assets | |
$ | 2,892 | | |
$ | 3,645 | |
During
fiscal years 2020 and 2021, the Company took advantage of the relief provisions provided by the U.S. government in response to COVID-19
under the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”). The CARES Act provides an employee retention credit
(“Employee Retention Credit”), which is a refundable tax credit against certain employment taxes dependent on certain qualified
wages paid to employees through fiscal year 2021. The Company qualifies for the tax credit under the CARES Act and continued to receive
additional tax credits under the additional relief provisions for qualified wages through the end of 2021. The Company accounts for these
labor related tax credits as a reduction to the expense that they are intended to compensate in the period in which the corresponding
expense is incurred and there is reasonable assurance the Company will both receive the tax credits and comply with all conditions attached
to the tax credits. As of June 30, 2024 and December 31, 2023, $0.3 million and $0.6 million was recorded as a receivable in prepaid
expenses and other current assets. The Company received $0.3 million during the six months ended June 30, 2024 and recorded a bad debt
for $0.01 million, received $0.7 million of the receivable during the six months ended June 30, 2023 and believes there is reasonable
assurance the remaining balance will be collected.
Property
and Equipment, Net
The
following table presents the components of property and equipment, net, as of June 30, 2024 and December 31, 2023 (in thousands):
SCHEDULE OF PROPERTY AND EQUIPMENT
| |
June 30, 2024 | | |
December 31, 2023 | |
Computer equipment | |
$ | 202 | | |
$ | 192 | |
Laboratory equipment | |
| 2,102 | | |
| 1,999 | |
Furniture and office equipment | |
| 29 | | |
| 29 | |
Leasehold improvements | |
| 76 | | |
| 73 | |
Total property and equipment,
gross | |
| 2,409 | | |
| 2,293 | |
Less: accumulated depreciation | |
| (2,063 | ) | |
| (1,977 | ) |
Total property and equipment, net | |
$ | 346 | | |
$ | 316 | |
Depreciation
expense was approximately $0.0 million and $0.1 million for both the three and six months ended June 30, 2024 and 2023, respectively.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Investment
in SAFE and Series Seed Preferred Stock
In
October 2021, the Company entered into a simple agreement for future equity (“Oncoheroes SAFE”) agreement for $1.5
million in exchange for a right to participate in a future equity financing of preferred stock to be issued by Oncoheroes
Biosciences Inc. (“Oncoheroes”). Alternatively, upon a dissolution or liquidity event such as a change in control or an
initial public offering, the Company would be entitled to receive a portion of $1.5
million. The number of shares of preferred stock would be determined by dividing the Oncoheroes SAFE purchase amount by the price
per share of the preferred stock issued in the respective equity financing. The Company recorded the investment of $1.5
million as an investment in the Oncoheroes SAFE on the condensed consolidated balance sheet as of December 31, 2023. The investment
in the Oncoheroes SAFE was treated as an investment in an equity security that the Company elected to record at its cost less any
impairment as of December 31, 2023.
Effective
April 15, 2024, the Oncoheroes SAFE converted into Series Seed Preferred Stock of Oncoheroes (“Series Seed Preferred
Stock”) with an aggregate liquidation preference of $1.5
million. The Company recorded the investment of $1.5 million
as an investment in Series Seed Preferred Stock on the condensed consolidated balance sheet(unaudited) as of June 30, 2024. The
investment in the Oncoheroes Series Seed Preferred Stock is treated as an investment in an equity security that the Company has
elected to record at its cost less any impairment as of June 30, 2024.
No
impairment losses have been recognized related to the investment for the three and six months ended June 30, 2024 and 2023 (See Note
8).
Accrued
Expenses and Other Current Liabilities
The
following table presents the components of accrued expenses and other current liabilities as of June 30, 2024 and December 31, 2023 (in
thousands):
SCHEDULE
OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
| |
June 30, 2024 | | |
December 31, 2023 | |
Accrued expenses | |
$ | 370 | | |
| 107 | |
Accrued employee expenses | |
| 8 | | |
| 78 | |
Accrued bonuses | |
| 431 | | |
| 233 | |
Total accrued expenses and other current liabilities | |
$ | 809 | | |
$ | 418 | |
NOTE
6 – TRADEMARKS
Costs
associated with the registration of trademarks have been capitalized in the amount of $1,300
and have been included in other assets. As of June 30, 2024 and December 31, 2023, no trademark has been filed, however, when the trademark is filed, the
costs will be amortized over the estimated useful life of 20
years.
NOTE
7 – ACCOUNTS PAYABLE - RELATED PARTIES
As
of June 30, 2024 and December 31, 2023, the Company owed related parties the following (in thousands):
SCHEDULE
OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES RELATED PARTIES
| |
June 30, 2024 | | |
December 31, 2023 | |
Board Member | |
$ | 22 | | |
$ | 42 | |
For
consulting services with the Board Member, the Company recorded general and administrative expenses of $65,691 and $128,250 for the three
and six months ended June 30, 2024 and $61,623 and $105,401 for the three and six months ended June 30, 2023.
NOTE
8 – CO-DEVELOPMENT AND LICENSE AGREEMENTS
Oncoheroes
Agreement
In
September 2021, the Company entered into an Exclusive License Agreement with Oncoheroes (the “Oncoheroes Agreement”) whereby
the Company obtained worldwide exclusive development and commercialization rights in the small molecule volasertib for uses relating
to certain types of cancer in adults. Under the terms of the Oncoheroes Agreement, Oncoheroes retains the right to develop and commercialize
volasertib for cancers not licensed to the Company.
Under
the terms of the agreement, the Company is obligated to make additional clinical and regulatory milestone payments up to a total of $8.0
million, plus tiered royalties from the mid-single digits up to mid-teens on net sales. When a licensed product is submitted to NDA,
the Company is required to pay $1 million, upon US NDA approval, the Company is required to pay $4 million and upon EU MAA Approval,
the Company is required to pay $3 million. In the event the Company grants a sublicense of rights, the Company will need to pay Oncoheroes
a high single digit percentage of any upfront payment obtained from such sublicenses. No milestones have been met during the six months
ended June 30, 2024 and 2023, and the Company did not make any royalty payments as the related product has not been approved for commercialization.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
Company also entered a SAFE agreement with Oncoheroes in October 2021 for $1.5 million recorded in the investment in SAFE on the condensed
consolidated balance sheets, as discussed in Note 5.
CicloMed
Agreement
In
July 2021, the Company entered into a Co-Development and Profit-Sharing Agreement with CicloMed LLC (“CicloMed”) (the
“CicloMed Agreement”) regarding use of the Company’s precision oncology diagnostic test in the research and
development of CicloMed’s CicloProx product for the treatment of acute myeloid leukemia. Under the terms of the co-development
agreement, CicloMed holds the primary responsibility for executing clinical trial operations while the Company is primarily focused
on optimizing the Company’s predictive medicines platform. Both parties will equally share the costs associated with the
on-going clinical trial incurred after the effective date. In the event a CicloProx product is commercially developed and sold, the
parties will share in the net proceeds. The Company recorded $0.0
million and $0.1
million for the three and six months ended June 30, 2024 and $0.1
million and $0.2
million for the three and six months ended June 30, 2023, respectively, as research and development expense related to this
agreement.
NOTE
9 – INCOME TAXES
As
of January 1, 2024, the Company had no unrecognized tax benefits, and accordingly, the Company did not recognize interest or penalties
during the six months ended June 30, 2024 related to unrecognized tax benefits. There has been no change in unrecognized tax benefits
during the six months ended June 30, 2024, and there was no accrual for uncertain tax positions as of June 30, 2024. Tax years from 2020
through 2023 remain subject to examination by major tax jurisdictions.
There
is no income tax benefit for the losses for the three and six months ended June 30, 2024 and 2023, since management has determined that
the realization of the net tax deferred asset is not assured and has created a valuation allowance for the entire amount of such benefits.
NOTE
10 - LEASES
The
following table summarizes total lease expense during the three and six months ended June 30, 2024 and 2023 (in thousands):
SCHEDULE
OF LEASES EXPENSES
| |
| | | |
| | | |
| | | |
| | |
| |
For the Three Months Ended | | |
For the Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Amortization of ROU assets - finance lease | |
$ | 20 | | |
$ | 20 | | |
$ | 40 | | |
$ | 27 | |
Interest on lease liabilities - finance lease | |
$ | 2 | | |
$ | 3 | | |
$ | 5 | | |
$ | 4 | |
Cash paid for financing lease liabilities | |
$ | 17 | | |
$ | - | | |
$ | 38 | | |
$ | - | |
Cash paid for operating lease liabilities | |
$ | 84 | | |
$ | 188 | | |
$ | 216 | | |
$ | 375 | |
Operating lease expense | |
$ | 137 | | |
$ | 186 | | |
$ | 257 | | |
$ | 371 | |
Variable lease expense | |
$ | - | | |
$ | 20 | | |
$ | 4 | | |
$ | 42 | |
Short-term lease expense | |
$ | 1 | | |
$ | 1 | | |
$ | 1 | | |
$ | 1 | |
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
following table summarizes amounts due under lease liabilities and the reconciliation of lease liabilities as of June 30, 2024 (in thousands):
SCHEDULE
OF MATURITIES OF LEASE LIABILITIES AND THE RECONCILIATION OF LEASE LIABILITIES
| |
Lease Obligation | |
| |
Finance Lease | | |
Facilities Lease | |
2024 | |
$ | 44 | | |
$ | 272 | |
2025 | |
| 87 | | |
| 552 | |
2026 | |
| 87 | | |
| 569 | |
2027 | |
| 87 | | |
| 239 | |
2028 and thereafter | |
| 15 | | |
| - | |
Total future undiscounted lease payments | |
| 320 | | |
| 1,632 | |
Less: imputed interest | |
| (17 | ) | |
| (140 | ) |
Total lease liabilities | |
$ | 303 | | |
$ | 1,492 | |
NOTE
11 – EQUITY INCENTIVE PLANS AND STOCK BASED COMPENSATION EXPENSE
2014
Equity Incentive Plan
In
September 2014, Notable’s shareholders approved the adoption of the Employee Share Ownership and Option Plan (2014) (“2014
Plan”) effective as of the closing of Notable’s public offering. Under the 2014 Plan, Notable reserved up to 26,514
Ordinary Shares. The Ordinary Shares to be issued
upon exercise of the options confer the same rights as the other Ordinary Shares, immediately upon allotment. Any
option which was granted under the 2014 Plan and was not exercised within twenty years from the date when it becomes exercisable, will
expire.
2015
Equity Incentive Plan
Notable
adopted the 2015 Equity Incentive Plan (the “2015 Plan”) in August 2015, which provides for the granting of ISO, NSO, and
restricted shares to employees, directors, and consultants. The 2015 Plan authorized a total of 37,199 shares reserved for future issuance.
Under amendments to the 2015 Plan, an additional 160,253 shares in 2017, 141,094 shares in 2019, and 31,450 shares in 2022 were authorized
to be reserved for future issuance. As of June 30, 2024, there were 66,975 Ordinary Shares reserved for future issuance pursuant to the
2015 Plan.
Options
under the 2015 Plan may be granted for periods of up to 10 years and at prices no less than 100% of the estimated fair value of the underlying
shares of common stock on the date of grant as determined by the Board provided that the exercise price of an ISO granted to a 10% stockholder
shall not be less than 110% of the estimated fair value of the shares on the date of grant. The 2015 Plan requires that options be exercised
no later than 10 years after the grant. Options granted to employees generally vest ratably on a monthly basis over four years, subject
to cliff vesting restrictions and continuing service.
2024
Employee Share Ownership and Option Plan
Notable
adopted the 2024 Employee Share Ownership and Option Plan (the “2024 Plan”) in March 2024, which provides for the
granting of ISO, NSO, restricted shares and restricted units to employees, directors, and consultants. The 2024 Plan authorized a
total of 4
million shares reserved for future issuance. The shares may be increased automatically (i)
on an annual basis on January 1 of each year (unless resolved otherwise by the Board of Directors), such that the number of shares
issuable under the Plan shall equal 35% of the Company’s issued and outstanding share capital on a fully diluted basis; and
(ii) in the event that any Ordinary Shares would have otherwise returned to the Company’s 2014 Plan, such Ordinary Shares
shall be added to the 2024 Plan. As of June 30, 2024, there were 4
million Ordinary Shares reserved for future issuance pursuant to the 2024 Plan.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Options
under the 2024 Plan may be granted for periods of up to 10 years and at prices no less than 100% of the estimated fair value of the underlying
shares of common stock on the date of grant as determined by the Board provided that the exercise price of an ISO granted to a 10% stockholder
shall not be less than 110% of the estimated fair value of the shares on the date of grant. The 2024 Plan requires that options be exercised
no later than 10 years after the grant. Options granted to employees generally vest ratably on a monthly basis over four years, subject
to cliff vesting restrictions and continuing service.
Share
Option Awards
The
following summarizes stock option activity under all of the Plans:
SCHEDULE
OF STOCK OPTIONS
| |
Options Outstanding | |
| |
Total Options
Outstanding | | |
Weighted-Average
Exercise Price | | |
Weighted-Average
Remaining
Contractual Life | | |
Aggregate
Intrinsic Value | |
| |
| | |
| | |
(in years) | | |
(in thousands) | |
Outstanding as of December 31, 2023 | |
| 284,437 | | |
$ | 49.67 | | |
| 4.0 | | |
$ | - | |
Granted | |
| 865,299 | | |
$ | 1.20 | | |
| - | | |
| - | |
Cancelled | |
| (154,368 | ) | |
$ | 67.26 | | |
| - | | |
| - | |
Outstanding as of June 30, 2024 | |
| 995,368 | | |
$ | 4.80 | | |
| 9.4 | | |
$ | - | |
Exercisable as of June 30, 2024 | |
| 136,101 | | |
$ | 25.67 | | |
| 7.4 | | |
$ | - | |
Vested and expected to vest as of June 30, 2024 | |
| 995,368 | | |
$ | 4.80 | | |
| 9.4 | | |
$ | - | |
No
options were exercised during the three and six months ended June 30, 2024 and 5,000 shares were exercised during the three and six months
ended June 30, 2023.
During
the three and six months ended June 30, 2024, the Company issued in aggregate 810,000
and 865,299
options to purchase the Company’s ordinary shares to board members, employees and consultants under the 2014 Plan and the 2024 Plan. The weighted-average grant date fair value of the options granted during
the three and six months ended June 30, 2024, was $1.19
and $1.20
per share. During the three and six months ended June 30, 2023, the Company did not issue any options. Notable estimated the fair
value of stock options using the Black-Scholes-Merton option pricing model which requires the use of highly subjective assumptions
to determine the fair value of stock-based awards. The fair value of employee and non-employee stock options is recognized as
expense on the straight-line basis over the requisite service period of the awards. These assumptions include:
|
● |
Risk-free
interest rate — The risk-free interest rate is based on the U.S. Treasury zero coupon issues in effect at the time of grant
for periods corresponding with the expected term of option. |
|
|
|
|
● |
Expected
volatility —The Company uses the volatility of the ordinary shares traded in the public market. |
|
|
|
|
● |
Expected
term — The expected term represents the period that stock-based awards are expected to be outstanding. The expected term
for option grants is determined using the simplified method. The simplified method deems the term to be the midpoint of the time-to-vesting
and the contractual term of the stock-based awards. The Company utilizes this method due to lack of historical exercise data. |
|
|
|
|
● |
Expected
dividend rate — The Company has never paid dividends on its ordinary shares and has no plans to pay dividends on its ordinary
shares. Therefore, the Company used an expected dividend yield of zero. |
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
fair value of stock options granted during the six months ended June 30, 2024 was estimated using the following weighted-average assumptions:
SCHEDULE
OF STOCK OPTIONS GRANTED ASSUMPTION
| |
2024 | |
Expected term (in years) | |
| 10 | |
Risk-free interest rate | |
| 4.2% - 4.5 | % |
Expected dividend rate | |
| - | % |
Expected volatility | |
| 168.%
- 170.7 | % |
The
following table summarizes the components of share-based compensation expense relating to options recognized in the Company’s condensed
consolidated statement of operations and comprehensive loss (in thousands):
SCHEDULE
OF SHARE BASED COMPENSATION
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 46 | | |
$ | 25 | | |
$ | 145 | | |
$ | 51 | |
General and administrative | |
| 109 | | |
| 177 | | |
| 143 | | |
| 267 | |
Total | |
$ | 155 | | |
$ | 202 | | |
$ | 288 | | |
$ | 318 | |
As
of June 30, 2024, the total share-based compensation expense related to stock awards not yet recognized was $1.3 million and will be
recognized over a weighted-average remaining period of approximately 2.8 years.
Restricted
Share Awards
The
following summarizes restricted stock awards (“RSA”) activity under all of the Plans:
SCHEDULE OF RESTRICTED STOCK AWARDS
| |
Total RSAs
Outstanding | |
| |
| |
Outstanding as of December 31, 2023 | |
| - | |
Granted | |
| 656,235 | |
Cancelled | |
| (15,000 | ) |
Outstanding as of June 30, 2024 | |
| 641,235 | |
Exercisable as of June 30, 2024 | |
| - | |
Vested and expected to vest as of June 30, 2024 | |
| 641,235 | |
During
the three and six months ended June 30, 2024, the Company issued RSAs to purchase 656,235 of the Company’s ordinary shares to Board
members and one consultant, with a fair market value of $780,920. None of the RSA’s have vested. Of the restricted share awards
to purchase 30,000 of the Company’s ordinary shares issued to the consultant, restricted share awards to purchase 15,000 of the
Company’s ordinary shares expired pursuant to their terms.
The
vesting terms of 226,235 RSAs are two equal annual installments beginning with the first anniversary of the RSAs, 400,000 of the RSAs are four equal annual installments beginning with the first anniversary of the RSAs and the vesting terms of
the remaining 15,000 are contingent on funding of the Company.
The
following table summarizes the components of share-based compensation expense relating to RSAs recognized in the Company’s condensed
consolidated statement of operations and comprehensive loss (in thousands):
SCHEDULE
OF SHARE BASED COMPENSATION
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
General and administrative | |
| 763 | | |
| - | | |
| 763 | | |
| - | |
Total | |
$ | 763 | | |
$ | - | | |
$ | 763 | | |
$ | - | |
As
of June 30, 2024, the total share-based compensation expense related to stock awards not yet recognized was $0.0 million.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
12 – NET LOSS PER SHARE
The
following table sets forth the computation of the basic and diluted net loss per share (in thousands except share and per share data):
SCHEDULE
OF BASIC AND DILUTED LOSS PER SHARE
| |
| | | |
| | | |
| | | |
| | |
| |
For the Three Months
Ended June 30, | | |
For the Six Months
Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (5,219 | ) | |
$ | (3,435 | ) | |
$ | (8,985 | ) | |
$ | (9,707 | ) |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted-average ordinary shares outstanding used to compute net loss per share, basic and diluted | |
| 9,455,751 | | |
| 970,402 | | |
| 9,235,006 | | |
| 970,297 | |
Net loss per share, basic and diluted: | |
$ | (0.55 | ) | |
$ | (3.54 | ) | |
$ | (0.97 | ) | |
$ | (10.00 | ) |
The
Company’s potentially dilutive securities have been excluded from the computation of diluted net loss per share as the effect would
be antidilutive. Therefore, the weighted-average number of ordinary shares outstanding used to calculate both basic and diluted net loss
per share is the same.
NOTE
13 – SUBSEQUENT EVENTS
On
July 17, 2024, the Company received a written notification (the “Notice”) from the Nasdaq
Stock Market LLC (“Nasdaq”), indicating that the Company was not in compliance with the minimum closing bid price requirement
set forth in Nasdaq Rules for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities
to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price
requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company’s
ordinary shares for the 30 consecutive business days from June 3, 2024, to July 16, 2024, the Company no longer meets the minimum bid
price requirement.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited
condensed consolidated interim financial statements and related notes included in this Form 10-Q. Our audited financial statements as
of and for the year ended December 31, 2023 have been prepared in accordance with U.S. Generally Accepted Accounting Principles, or U.S.
GAAP, and our unaudited condensed consolidated interim financial statements for the periods ended June 30, 2024, or the periods, have
been prepared in accordance with U.S. GAAP, “Interim Reporting,” or ASC 270 and Article 10 of Regulation S-X. Unless stated
otherwise, comparisons included herein are made to the three or six month period ended on June 30, 2024, or the parallel period. Unless
the context requires otherwise, references in this Management’s Discussion and Analysis of Financial Condition and Results of Operations
to the “Company”, “Notable,” “we,” “us,” and “our” refer to Notable Labs,
Ltd. and its consolidated subsidiaries. You should read the “Risk Factors” section included in our Annual Report on Form
10-K for the fiscal year ended December 31, 2023 and other subsequent SEC filings, for a discussion of important factors that could cause
actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following
discussion and analysis.
Overview
Notable
is a clinical-stage platform therapeutics company developing predictive medicines for patients with cancer. Through its proprietary
Predictive Medicines Platform or PMP, Notable bio-simulates a patient’s cancer treatment ex vivo (outside of the body)
and seeks to precisely predict whether or not an individual patient will clinically respond to their actual treatment. In four
independent clinical validation trials with recognized medical centers, an average 97% of PMP predicted responders achieved a clinical response to their actual treatment. To pursue improved medical outcomes compared to traditional precision medicines, PMP does not depend on genetic or other
biomarkers. Instead, PMP generates multi-dimensional measures of biological response of cells to drugs and then integrates and
translates these data by computational algorithms into a patient response predictor.
PMP
is designed to enable Notable to identify and select patients expected to be clinically responsive prior to the initiation of their treatment
and potentially enable fast-track therapeutic development in this patient population. Notable utilizes its PMP to evaluate investigational
compounds for in-licensing and development or co-development that have shown clinical activity, with the goal of improving patient response
and the success, speed and value of developing these compounds, compared with traditional drug development.
Using
PMP, Notable targets in-licensing assets that have already demonstrated compelling clinical activity but have been abandoned because
the activity was limited to a subset of 10% to 30% of treated patients, a likely hurdle to successful development, regulatory approval,
and commercialization. Notable has screened and evaluated hundreds of assets on its PMP platform, and for many of these assets, believes
it can predict with relatively high precision which patients will clinically respond. This provides Notable with the opportunity to selectively
enroll predicted responders into clinical trials, and thus to fast-track development of these assets selectively in clinical responders
delivering higher response rates.
Notable
is seeking to create a growing portfolio of predictive medicines using its PMP. PMP has already guided Notable in the selection of its
first two candidate predictive medicines, two clinical-stage candidates for development in platform-predicted responders with acute myeloid
leukemia (“AML”). Notable’s lead asset derived from PMP is Volasertib, a polo like kinase 1 (“PLK1”) inhibitor
proven to induce cell cycle arrest and apoptosis in various cancer cells.
Notable
in-licensed Volasertib after extensive analysis on our PMP and has been actively preparing to initiate our Phase 2 study in
relapsed/refractory AML (r/r AML). We anticipate initial Phase 2 safety data to begin reading out in the fourth quarter of 2024 with
the first patient cohort completion in the first quarter of 2025. We expect initial efficacy data in the first half of 2025.
In addition, Notable is co-developing, with CicloMed LLC (“CicloMed”), Fosciclopirox for patients with AML. This
co-development partnership resulted from a successful pre-clinical application of PMP for Fosciclopirox. Notable is also using PMP to
identify additional compelling assets for in-licensing and fast-tracking additional assets as it builds out its development pipeline.
By
continually advancing and expanding the reach of the PMP across patient segments, diseases and predicted medical outcomes, Notable aims
to be the leader in predictive precision medicine and revolutionize the way in which patients seek and receive treatments that are most
likely to work best for them – with major impact for patients and the healthcare community.
Merger
Transaction
On
October 16, 2023, pursuant to the Merger Agreement, by and among the Company, Merger Sub and Notable Labs, Inc., Merger Sub was merged
with and into Notable Labs, Inc., with Notable Labs, Inc. continuing after the merger as the surviving entity and a wholly owned subsidiary
of the Company. At the effective time of the Merger, without any action on the part of any stockholder, each issued and outstanding share
of pre-Merger Notable Labs, Inc.’s common stock, par value $0.001 per share (the “Notable Labs, Inc. Common Stock”),
including shares underlying pre-Merger Notable Labs, Inc.’s outstanding equity awards, was converted into the right to receive
0.0629 shares (the “Exchange Ratio”) of the Company’s common stock, 0.35 NIS par value per share (the “Company
Ordinary Shares”), Immediately following the effective time of the Merger, the Company effected a 1-for-35 reverse stock split
of the issued and outstanding Company Ordinary Shares (the “Reverse Stock Split”). Upon completion of the Merger and the
transactions contemplated in the Merger Agreement, (i) the former Notable Labs, Inc. equity holders owned approximately 71.9% of the
outstanding equity of the Company on a fully diluted basis, assuming the exercise in full of warrants to purchase 94,988 Company Ordinary
Shares and including 160,635 Company Ordinary Shares underlying options to purchase shares of Notable Labs, Inc.’s Common Stock
assumed by the company at closing and after adjustments based on the Company’s net cash at closing; and (ii) former Vascular Biogenics,
Ltd. shareholders owned approximately 28.1% of the outstanding equity of the Company.
The
Merger was treated as a reverse recapitalization effected by a share exchange for financial accounting and reporting purposes. Notable
Labs, Inc. was being treated as the accounting acquirer, as its stockholders control the Company after the Merger, even though Vascular
Biogenics, Ltd. was the legal acquirer. As a result, the assets and liabilities and the historical operations that are reflected in our
consolidated financial statements are those of Notable Labs, Inc. as if Notable Labs, Inc. had always been the reporting company. All
references to ordinary shares, warrants and options have been presented on a post-merger, post-reverse split basis.
Nasdaq
Listing Deficiency Notice
On
July 17, 2024, Notable received a written notification (the “Notice”) from the Nasdaq Stock Market LLC (“Nasdaq”),
indicating that it was not in compliance with the minimum closing bid price requirement set forth in Nasdaq Rules for continued listing
on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per
share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues
for a period of 30 consecutive business days. Based on the closing bid price of Notable’s ordinary shares for the 30 consecutive
business days from June 3, 2024, to July 16, 2024, Notable no longer met the minimum bid price requirement.
The
Notice has no immediate effect on the listing of Notable’s ordinary shares on the Nasdaq Capital Market. Pursuant to Nasdaq Listing
Rule 5810(c)(3)(A), Notable has been granted a 180-calendar-day compliance period, or until January 13, 2025, to regain compliance with
the minimum bid price requirement. During the compliance period, Notable’s ordinary shares will continue to be listed and traded
on the Nasdaq Capital Market. To regain compliance, the closing bid of our ordinary shares must meet or exceed $1.00 per share for a
minimum of ten (10) consecutive business days during the 180-calendar-day grace period. In the event Notable is not in compliance by
January 13, 2025, it may be afforded a second 180-calendar-day grace period. To qualify, Notable would be required to meet the continued
listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with
the exception of the minimum bid price requirement. If Notable does not regain compliance within the allotted compliance period(s), including
any extensions that may be granted by Nasdaq, Nasdaq will provide notice that Notable’s ordinary shares will be subject to delisting.
Under such circumstances, Notable would have the right to appeal a determination to delist the ordinary shares, and Notable’s ordinary
shares would remain listed on the Nasdaq Capital Market until the completion of the appeal process.
Notable
intends to monitor the closing bid price for its ordinary shares between now and January 13, 2025, and will consider any such available
options to resolve its non-compliance with the minimum bid price requirement as may be necessary. No determination regarding Notable’s
response has been made at this time. There can be no assurance that Notable will be able to regain compliance with the minimum bid price
requirement or will otherwise be in compliance with other Nasdaq listing criteria. If Notable fails to satisfy any other continued listing
requirements of Nasdaq, such as the corporate governance requirements, Nasdaq may also take steps to delist the ordinary shares. Such
a delisting would likely have a negative effect on the price of Notable’s ordinary shares and would impair an investor’s
ability to sell or purchase the ordinary shares when they wish to do so. In the event of a delisting, Notable can provide no assurance
that any action taken by it to restore compliance with listing requirements would allow Notable’s ordinary shares to become listed
again, stabilize the market price or improve the liquidity of its ordinary shares, prevent the ordinary shares from dropping below the
Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.
Financial
Overview
Revenues
and Cost of Revenues
Notable
does not expect to generate any material revenue from the sale of any products unless or until Notable obtains regulatory approval of
and commercializes any of its therapeutic products.
Notable
continued to perform certain diagnostics services on a limited basis as an outsourced provider through the six months ended June 30,
2024, but such activities do not represent its major and ongoing central operations and Notable does not expect to derive any material
revenue as a result.
Notable
recognizes revenue from diagnostic services in the amount that reflects the consideration that it expects to be entitled as Notable performs
its obligation under a contract with a customer by processing diagnostic tests on laboratory samples and making the test results available
to its customers. Revenue is recorded considering a five-step revenue recognition model that includes identifying the contract with a
customer, identifying the performance obligations in the contract, determining the transaction price, allocating the transaction price
to the performance obligations, and recognizing revenue when, or as, an entity satisfies a performance obligation. Notable generally
has a contract or a purchase order from a customer with the specified required terms, including the number of diagnostic samples to be
performed. Notable has not received any advance payments for which there are any remaining performance obligations. Accordingly, no deferred
revenue is recorded as of June 30, 2024 and December 31, 2023. Notable has not recorded any contract assets as of June 30, 2024 and December
31, 2023, and as of June 30, 2024 Notable had not completed any performance obligations for which it has not been able to bill its customers.
Material costs of services revenue are recorded as costs of sales and immaterial costs of services and are recorded in operating expenses.
Research
and Development Expenses
Research
and development expenses are charged to expense as incurred. Research and development expenses include payroll and personnel costs related
to research and development activities, materials costs, external clinical drug product manufacturing costs, outside services costs,
repair, maintenance and depreciation costs for research and development equipment, as well as facility costs used for research and development
activities. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities
are capitalized and expensed as the goods are delivered or the related services are performed. Notable continues to evaluate whether
it expects the goods to be delivered or services to be rendered and charges to expense any portion of the advance payment that has been
capitalized when the entity no longer expects the goods to be delivered or services to be rendered.
Notable
expects to significantly increase its research and development efforts by conducting the remaining studies necessary for the development
and approval of Volasertib and Fosciclopirox. Future research and development expenses may include:
● |
employee-related
expenses, such as salaries, bonuses and benefits, consultant-related expenses, share-based compensation, overhead related expenses
and travel related expenses for Notable’s research and development personnel; |
● |
expenses
incurred under agreements with CROs, as well as consultants that support the implementation of the clinical studies described above; |
|
|
● |
manufacturing
and packaging costs in connection with conducting clinical trials and for stability and other studies required to support the NDA
filing as well as manufacturing drug product for commercial launch; |
|
|
● |
formulation,
research and development expenses related to the PMP, Volasertib and Fosciclopirox and other products Notable may choose to develop;
and |
● |
costs
for sponsored research. |
Research
and development activities will continue to be central to Notable’s business plan. Products in later stages of clinical development
generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and
duration of later-stage clinical trials. Notable expects its research and development expenses to be significant over the next several
years as personnel and compensation costs increase and Notable conducts late-stage clinical studies and prepares to seek regulatory approval
for Volasertib and Fosciclopirox and any other future product.
The
duration, costs and timing of clinical trials of Volasertib and Fosciclopirox and any other future product will depend on a variety of
factors that include, but are not limited to:
|
● |
the
number of trials required for approval; |
|
|
|
|
● |
the
per patient trial costs; |
|
|
|
|
● |
the
number of patients that participate in the trials; |
|
|
|
|
● |
the
number of sites included in the trials; |
|
|
|
|
● |
the
countries in which the trial is conducted; |
|
|
|
|
● |
the
length of time required to enroll eligible patients; |
|
|
|
|
● |
the
number of doses that patients receive; |
|
|
|
|
● |
the
drop-out or discontinuation rates of patients; |
|
|
|
|
● |
the
potential additional safety monitoring or other studies requested by regulatory agencies; |
|
|
|
|
● |
the
duration of patient follow-up; |
|
|
|
|
● |
the
timing and receipt of regulatory approvals; and |
|
|
|
|
● |
the
efficacy and safety profile of Notable’s product candidates. |
General
and Administrative Expenses
General
and administrative expenses consist primarily of employee-related expenses, including salaries, benefits and stock-based compensation,
for personnel in executive, finance, business development, facility and administrative functions. Other significant costs include facility
costs not otherwise included in research and development expenses, legal fees relating to patent and corporate matters and fees for accounting,
tax and consulting services.
Notable
anticipates that general and administrative expenses will increase in the future to support its continued research and development activities.
These increases will likely include increased costs related to the hiring of personnel, including compensation and employee-related expenses,
and fees to outside consultants, lawyers and accountants. Additionally, Notable anticipates increased costs associated with being a public
company, including compliance with Nasdaq Capital Market and SEC requirements, insurance and investor relations costs.
Income
Taxes
For
the six months ended June 30, 2024 and 2023, no income tax expense or benefit was recognized. Notable’s deferred tax assets are
comprised primarily of net operating loss carryforwards. At June 30, 2024, Notable had federal and state net operating loss carryforwards
of approximately $130.8 million and foreign net operating loss carryforwards of $264.2 million. Notable maintains a full valuation allowance
on its deferred tax assets since Notable has not yet achieved sustained profitable operations and does not expect taxable income in the
near future. As a result, Notable has not recorded any income tax benefit since its inception.
Results
of Operations
Comparison
of the Three Months Ended June 30, 2024 and June 30, 2023
The
following table sets forth Notable’s results of operations for the three months ended June 30, 2024 compared to the three months
ended June 30, 2023 (in thousands):
| |
| | |
| | |
2024 | |
| |
Three Months ended June 30, | | |
Increase | |
| |
2024 | | |
2023 | | |
(Decrease) | |
Services revenue | |
$ | 2 | | |
$ | - | | |
$ | 2 | |
Cost of services | |
| - | | |
| - | | |
| - | |
Operating expenses: | |
| | | |
| | | |
| | |
Research and development | |
| 2,354 | | |
| 1,054 | | |
| 1,300 | |
General and administrative | |
| 3,028 | | |
| 1,932 | | |
| 1,096 | |
Loss from operations | |
| (5,380 | ) | |
| (2,986 | ) | |
| (2,394 | ) |
Other income (expense), net | |
| | | |
| | | |
| | |
Change in fair value of SAFEs | |
| - | | |
| (858 | ) | |
| 858 | |
Change in fair value of warrant liability | |
| 100 | | |
| 408 | | |
| (308 | ) |
Other income | |
| 61 | | |
| 1 | | |
| 60 | |
Net loss | |
$ | (5,219 | ) | |
$ | (3,435 | ) | |
$ | (1,784 | ) |
Services
Revenue
Services
revenue increased from $0 to $2 thousand for the three months ended June 30, 2024 compared to the three months ended June 30, 2023. This
increase of $2 thousand was the result of Notable’s performing diagnostic services for others.
Research
and Development Expenses
Research
and development expenses increased $1.3 million for the three months ended June 30, 2024 compared to the three months ended June 30,
2023. The change was primarily due to the increases and decreases in the following programs (in thousands):
| |
| | |
| | |
2024 | |
| |
Three Months ended June 30, | | |
Increase | |
| |
2024 | | |
2023 | | |
(Decrease) | |
Predictive Medicines Platform (“PMP”) | |
$ | 244 | | |
$ | 195 | | |
$ | 49 | |
Medical affairs | |
| 20 | | |
| - | | |
| 20 | |
Scientific projects | |
| 747 | | |
| 859 | | |
| (112 | ) |
Volasertib | |
| 1,343 | | |
| - | | |
| 1,343 | |
Total | |
$ | 2,354 | | |
$ | 1,054 | | |
$ | 1,300 | |
Reclassification—Certain
prior year amounts have been reclassified to conform to the three months ended June 30, 2024 presentation.
PMP
expenses are costs necessary to support the PMP platform. PMP expenses remained materially consistent for the three months ended June
30, 2024 compared to the three months ended June 30, 2023. The immaterial increase is primarily related to payroll costs.
Medical
affairs expenses include costs of clinical planning. Medical affairs expenses remained materially consistent for the three months ended
June 30, 2024 compared to the three months ended June 30, 2023. The immaterial increase related primarily to establishing relationships
for the Volasterib project.
Scientific
projects are exploratory research and development projects. The decrease in scientific project expenses for the three months ended June
30, 2024 compared to the three months ended June 30, 2023, were a result of costs associated with the Fosciclopirox program during the
three months ended June 30, 2023 that were not incurred during the three months ended June 30, 2024.
Volasertib
is a small molecule with certain uses related to cancer. The increase in the Volasertib expenses for the three months ended June 30,
2024 compared to the three months ended June 30, 2023 related to preparation for the start of the clinical trial.
General
and Administrative Expenses
General
and administrative expenses increased to $3.0 million from $1.9 million for the three months ended June 30, 2024 compared to the
three months ended June 30, 2023. The increase of $1.1 million, or 56.7%, was due primarily to increases in payroll related expenses
of 0.1 million, or 5.2%; consulting fees of $0.3 million, or 14.6%; business development expenses of $0.1, or 5.3%; directors and
officers insurance of $0.3 million, or 16.7% and share-based compensation of $0.7 million or 38.4%; partially offset by decreases in legal and professional fees primarily related to the
merger for the three months ended June 30, 2023 that were non-recurring during the three months ended June 30, 2024 of $0.4 million,
or 21.5%; and facilities expenses of $0.1 million, or 5.3% resulting from repurposing of space for research and development
activities.
Other
Income (Expense), Net
Other
income (expense), net, increased to $0.2 million of other income, net, from $0.4 million of other expense, net for the three months ended
June 30, 2024 compared to the three months ended June 30, 2023. The increase of $0.6 million, or 135.8%, was primarily due to the increase
in the unrealized loss of convertible debt of $0.9 million during the three months ended June 30, 2023 not recurring during the three
months ended June 30, 2024, the decrease in the derivative fair value of the Series C SAFE warrant liability of $0.4 million during the
three months ended June 30, 2023 not recurring during the three months ended June 30, 2024 and the increase in interest income during
the three months ended June 30, 2024 as compared to the three months ended June 30, 2023.
Net
Loss
Net
loss increased to $5.2 million from $3.4 million for the three months ended June 30, 2024 compared to the three months ended June 30,
2023. The increase of $1.8 million, or 51.9%, was due to the factors described above.
Comparison
of the Six Months Ended June 30, 2024 and June 30, 2023
The
following table sets forth Notable’s results of operations for the six months ended June 30, 2024 compared to the six months ended
June 30, 2023 (in thousands):
| |
| | |
| | |
2024 | |
| |
Six Months ended June 30, | | |
Increase | |
| |
2024 | | |
2023 | | |
(Decrease) | |
Services revenue | |
$ | 3 | | |
$ | - | | |
$ | 3 | |
Cost of services | |
| - | | |
| - | | |
| - | |
Operating expenses: | |
| | | |
| | | |
| | |
Research and development | |
| 3,904 | | |
| 2,650 | | |
| 1,254 | |
General and administrative | |
| 5,317 | | |
| 5,855 | | |
| (538 | ) |
Loss from operations | |
| (9,218 | ) | |
| (8,505 | ) | |
| (713 | ) |
Other income (expense), net | |
| | | |
| | | |
| | |
Change in fair value of SAFEs | |
| - | | |
| (2,723 | ) | |
| 2,723 | |
Change in fair value of warrant liability | |
| 111 | | |
| 1,504 | | |
| (1,393 | ) |
Other income | |
| 122 | | |
| 17 | | |
| 105 | |
Net loss | |
$ | (8,985 | ) | |
$ | (9,707 | ) | |
$ | (722 | ) |
Services
Revenue
Services
revenue increased from $0 to $3 thousand for the six months ended June 30, 2024 compared to the six months ended June 30, 2023. This
increase of $3 thousand was the result of Notable’s performing diagnostic services for others.
Research
and Development Expenses
Research
and development expenses increased $1.3 million for the six months ended June 30, 2024 compared to the six months ended June 30, 2023.
The change was primarily due to the increases and decreases in the following programs (in thousands):
| |
| | |
| | |
2024 | |
| |
Six Months ended June 30, | | |
Increase | |
| |
2024 | | |
2023 | | |
(Decrease) | |
Predictive Medicines Platform (“PMP”) | |
$ | 460 | | |
$ | 434 | | |
$ | 26 | |
Medical affairs | |
| 21 | | |
| - | | |
| 21 | |
Scientific projects | |
| 1,564 | | |
| 1,753 | | |
| (189 | ) |
Volasertib | |
| 1,859 | | |
| 463 | | |
| 1,396 | |
Total | |
$ | 3,904 | | |
$ | 2,650 | | |
$ | 1,254 | |
Reclassification—Certain
prior year amounts have been reclassified to conform to the six months ended June 30, 2024 presentation.
PMP
expenses are costs necessary to support the PMP platform. PMP expenses remained materially consistent for the six months ended June 30,
2024 compared to the six months ended June 30, 2023. The immaterial increase is primarily related to payroll costs.
Medical
affairs expenses include costs of clinical planning. Medical affairs expenses remained materially consistent for the six months ended
June 30, 2024 compared to the six months ended June 30, 2023. The immaterial increase related primarily to establishing relationships
for the Volasterib project.
Scientific
projects are exploratory research and development projects. The decrease in scientific project expenses for the six months ended June
30, 2024 compared to the six months ended June 30, 2023, were primarily a result of costs associated with the Fosciclopirox program during
the six months ended June 30, 2023 that were not incurred during the six months ended June 30, 2024.
Volasertib
is a small molecule with certain uses related to cancer. The increase in the Volasertib expenses for the six months ended June 30, 2024
compared to the six months ended June 30, 2023 related to preparation for the start of the clinical trial.
General
and Administrative Expenses
General
and administrative expenses decreased to $5.3 million from $5.9 million for the six months ended June 30, 2024 compared to the six months
ended June 30, 2023. The decrease of $0.5 million, or 9.2%, was due primarily to decreases in consulting fees of $0.1 million, or 2.3%;
legal and professional fees primarily related to the merger for the six months ended June 30, 2023 that were non-recurring during the
six months ended June 30, 2024 of $2.2 million, or 37.9%; facilities expenses of $0.2 million, or 2.9% resulting from repurposing of
space for research and development activities; partially offset by increases in payroll related expenses of 0.1 million, or 2.1%; business
development expenses of $0.2, or 2.9%; directors and officers insurance of $0.7 million, or 11.9%; board of director fees of $0.2
million or 4.2% and stock based compensation of $0.7 million or 11.7%.
Other
Income (Expense), Net
Other
income (expense), net, increased to $0.2 million of other income, net, from $1.2 million of other expense, net for the six months ended
June 30, 2024 compared to the six months ended June 30, 2023. The increase of $1.4 million, or 119.5%, was primarily due to the increase
in the unrealized loss of convertible debt of $2.7 million during the six months ended June 30, 2023 not recurring during the six months
ended June 30, 2024, the decrease in the derivative fair value of the Series C SAFE warrant liability of $1.4 million during the six
months ended June 30, 2023 not recurring during the six months ended June 30, 2024 and the increase in interest income during the six
months ended June 30, 2024 as compared to the six months ended June 30, 2023.
Net
Loss
Net
loss decreased to $9.0 million from $9.7 million for the six months ended June 30, 2024 compared to the six months ended June 30, 2023.
The decrease of $0.7 million, or 7.4%, was due to the factors described above.
Liquidity,
Capital Resources, and Financial Requirements
Overview
For
the period from inception through June 30, 2024, Notable has incurred losses and negative cash flows from operations mainly attributable
to its development efforts and has an accumulated deficit of $91.3 million. Notable has financed its operations primarily through the
issuance of equity securities and through the cash inflow as a result of the Merger completed on October 16, 2023. Notable does not expect
to have positive cash flow for the foreseeable future and does not believe the existing cash resources will be sufficient to sustain
operations during the next twelve months. We currently need to generate sufficient revenues to support our cost structure to enable us
to pay ongoing costs and expenses as they are incurred, finance the development of our products, and execute the business plan. If we
cannot generate sufficient revenue to fund our business plan, we intend to seek to raise such financing through the sale of debt and/or
equity securities. The issuance of additional equity would result in dilution to existing shareholders. If we are unable to obtain additional
funds when they are needed or if such funds cannot be obtained on terms acceptable to us, we will be unable to execute upon the business
plan or pay costs and expenses as they are incurred, which would have a material, adverse effect on our business, financial condition
and results of operations. Even if we are successful in generating sufficient revenue or in raising sufficient capital in order commercialize
our products, our ability to continue in business as a viable going concern can only be achieved when our revenues reach a level that
sustains our business operations.
As
of August 9, 2024, Notable has cash and cash equivalents of $3.2 million. Based on the current cash position and the Company’s
planned expense run rate, management believes Notable will be able to finance its operations through September 2024. Notable has based
this estimate on assumptions that may prove to be wrong and may deplete its capital resources sooner than it expects.
Notable
expects to continue to incur significant and increasing operating losses at least for the foreseeable future. Notable does not expect
to generate product revenue unless and until it successfully completes development of and obtains regulatory approval for Volasertib,
Fosciclopirox, or any other future products. Notable’s net losses may fluctuate significantly from quarter-to-quarter and year-to-year,
depending on the timing of planned clinical trials and Notable’s expenditures on other research and development activities. Notable
anticipates that its expenses will increase substantially in 2024 as Notable advances the clinical development of Volasertib and Fosciclopirox,
and operates as a publicly traded company. Notable does not expect positive cash flows from operations in the foreseeable future. Notable
management expects to continue to incur additional substantial losses in the foreseeable future as a result of expanded research and
development activities until regulatory approval is granted. Regulatory approval is not guaranteed and may never be obtained. As a result,
these conditions raise substantial doubt about Notable’s ability to continue as a going concern within one year after the date
that the condensed consolidated financial statements are issued.
The
foregoing forward-looking information was prepared by us in good faith based upon assumptions that we believe to be reasonable. No assurance
can be given, however, regarding the attainability of the projections or the reliability of the assumptions on which they are based.
The projections are subject to the uncertainties inherent in any attempt to predict the results of our operations, especially where new
products and services are involved. Certain of the assumptions used will inevitably not materialize and unanticipated events will occur.
Actual results of operations are, therefore, likely to vary from the projections and such variations may be material and adverse to us.
Accordingly, no assurance can be given that such results will be achieved. Moreover, due to changes in technology, new product announcements
and competitive pressures, we may be required to change the current plans.
Future
Funding Requirements
Notable
expects that it will need to obtain further funding through other public or private offerings of Notable’s capital stock, debt
financing, collaboration and licensing arrangements or other sources, the requirements for which will depend on many factors, including:
● |
the
scope, timing, rate of progress and costs of Notable’s drug development efforts, preclinical development activities, laboratory
testing and clinical trials for Notable’s product candidates; |
|
|
● |
the
number and scope of clinical programs Notable decides to pursue; |
|
|
● |
the
cost, timing and outcome of preparing for and undergoing regulatory review of Notable’s product candidates; |
|
|
● |
the
scope and costs of development and commercial manufacturing activities; |
|
|
● |
the
cost and timing associated with commercializing Notable’s product candidates, if they receive marketing approval; |
|
|
● |
the
extent to which Notable acquires or in-licenses other product candidates and technologies; |
|
|
● |
the
costs of preparing, filing and prosecuting patent applications, maintaining and enforcing Notable’s intellectual property rights
and defending intellectual property-related claims; |
|
|
● |
Notable’s
ability to establish and maintain collaborations on favorable terms, if at all; |
● |
Notable’s
efforts to enhance operational systems and Notable’s ability to attract, hire and retain qualified personnel, including personnel
to support the development of Notable’s product candidates and, ultimately, the sale of Notable’s products, following
FDA approval; |
|
|
● |
Notable’s
implementation of operational, financial and management systems; and |
|
|
● |
the
costs associated with being a public company. |
A
change in the outcome of any of these or other variables with respect to the development of any of Notable’s product candidates
could significantly change the costs and timing associated with the development of such product candidate. Furthermore, Notable’s
operating plans may change in the future, and Notable will continue to require additional capital to meet operational needs and capital
requirements associated with such operating plans.
Adequate
additional funding may not be available to Notable on acceptable terms, or at all. If Notable is unable to raise capital in sufficient
amounts or on terms acceptable to it, Notable may have to significantly delay, scale back or discontinue the development or commercialization
of Volasertib and Fosciclopirox, or any future product, or potentially discontinue operations.
To
the extent that Notable raises additional capital through the sale of equity or convertible debt securities, the ownership interest of
Notable shareholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect
the rights of Notable Ordinary Shareholders. Debt financing and preferred equity financing, if available, may involve agreements that
include covenants limiting or restricting Notable’s ability to take specific actions, such as incurring additional debt, making
capital expenditures or declaring dividends.
If
Notable raises additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with
third parties, Notable may be required to relinquish valuable rights to Notable’s technologies, future revenue streams, research
programs or proposed products, or to grant licenses on terms that may not be favorable to Notable. If Notable is unable to raise additional
funds through equity or debt financings when needed, Notable may be required to delay, limit, reduce or terminate Notable’s drug
development or future commercialization efforts or grant rights to develop and market any future product, that Notable would otherwise
prefer to develop and market itself.
Because
Notable is currently engaged in research at a relatively early stage, it will take a significant amount of time and resources to develop
any product or intellectual property capable of generating sustainable revenues. Accordingly, Notable’s business is unlikely to
generate any sustainable operating revenues in the next several years, and may never do so. In addition, to the extent that Notable is
able to generate operating revenues, there can be no assurances that Notable will be able to achieve positive earnings and operating
cash flows.
Cash
Flows
Comparison
of the Six Months Ended June 30, 2024 and June 30, 2023
The
following table sets forth the primary sources and uses of cash for each of the periods set forth below (in thousands):
| |
Six Months ended June 30, | | |
| |
| |
2024 | | |
2023 | | |
Change | |
Cash used in operating activities | |
$ | (7,271 | ) | |
$ | (5,833 | ) | |
$ | (1,438 | ) |
Cash used in investing activities | |
| (15 | ) | |
| (30 | ) | |
| 15 | |
Cash provided by (used in) financing activities | |
| (344 | ) | |
| 6,178 | | |
| (6,522 | ) |
| |
| | | |
| | | |
| | |
Net increase (decrease) in cash and cash equivalents | |
$ | (7,630 | ) | |
$ | 315 | | |
$ | (7,945 | ) |
Cash
Flows used in Operating Activities
Net
cash used in operating activities was $7.3 million and $5.8 million for the six months ended June 30, 2024 and 2023, respectively, representing
an increase of $1.4 million or approximately 24.6%. The increase was primarily due to increased expenses in planning for the start of
the clinical trial.
Cash
Flows used in Investing Activities
Net
cash used in investing activities was $0 million for the six months ended June 30, 2024 and 2023.
Cash
Flows from Financing Activities
Net
cash used in financing activities was $0.3 million for the six months ended June 30, 2024 and net cash provided by financing activities
was $6.2 million for the six months ended June 30, 2023, representing a decrease of $6.5 million. For the six months ended June 30, 2023,
the increase primarily represents net proceeds from issuance of SAFE Agreements, which were not recurring during the six months ended
June 30, 2024.
Critical
Accounting Policies and Use of Estimates
Notable’s
discussion and analysis of its financial condition and results of operations are based on Notable’s financial statements, which
have been prepared in accordance with GAAP. The preparation of these financial statements requires Notable to make estimates and judgments
that affect the reported amounts of assets, liabilities, revenues, and expenses and the disclosure of contingent assets and liabilities
in Notable’s financial statements. On an ongoing basis, Notable evaluates its estimates and judgments, including those related
to accrued expenses, valuation allowance on deferred tax assets and valuation of intangible assets. Notable bases its estimates on historical
experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results
of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other
sources. Actual results may differ from these estimates under different assumptions or conditions.
Our
financial statements are impacted by the accounting policies used and the estimates and assumptions made by management during their preparation.
A complete summary of these policies is included in Note 2 of the Notes to the Consolidated Financial Statements in our Annual Report
on Form 10-K for the year ended December 31, 2023. We have identified below the accounting policies that are of particular importance
in the presentation of our financial position, results of operations and cash flows and which require the application of significant
judgment by management.
Stock-Based
Compensation Expense
We
have adopted the fair value recognition provisions contained in Financial Accounting Standards Board Accounting Standards Codification
(“FASB ASC”) 718. In addition, the Securities and Exchange Commission issued Staff Accounting Bulletin No. 107 “Share-Based
Payment” (“SAB 107”), which provides supplemental FASB ASC 718 application guidance based on the views of the SEC.
Under FASB ASC 718, compensation cost recognized includes compensation cost for all share-based payments granted, based on the grant
date fair value estimated in accordance with the provisions of FASB ASC 718.
We
have used the Black-Scholes-Merton option-pricing model to estimate the option fair values. The option-pricing model requires a number
of assumptions, of which the most significant are, expected stock price volatility, the expected pre-vesting forfeiture rate and the
expected option term (the amount of time from the grant date until the options are exercised or expire).
All
issuances of stock options or other equity instruments to non-employees as consideration for goods or services received by Notable are
accounted for based on the fair value of the equity instruments issued. Non-employee equity-based payments that do not vest immediately
upon grant are recorded as an expense over the vesting period.
Fair
Value Measurement
Fair
value accounting is applied for all financial assets and liabilities that are recognized or disclosed at fair value in the financial
statements on a recurring basis. Financial instruments such as cash and cash equivalents, accounts receivable, accounts payable and accrued
liabilities approximate fair value due to their relatively short maturities.
Assets
and liabilities recorded at fair value on a recurring basis in the balance sheet are categorized based on the level of judgment associated
with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or
an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an
orderly transaction between market participants on the measurement date.
Warrants
issued pursuant to equity offerings that are potentially exercisable in cash or on a cashless basis resulting in a variable number of
shares being issued are considered derivative liabilities and therefore measured at fair value.
Accrued
Research and Development Costs
Notable
accrues for expenses resulting from obligations under contracts with clinical research organizations (CROs). The financial terms of these
contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods
over which materials or services are provided. Notable’s objective is to reflect the appropriate trial expense in the financial
statements by matching the appropriate expenses with the period in which services and efforts are expended.
Warrant
Liabilities
Notable
classifies warrants to purchase ordinary shares as liabilities at fair value and adjusts the instruments to fair value at each reporting
period. The warrants to purchase ordinary shares are subject to re-measurement at each balance sheet date until exercised or expired,
and any change in fair value is recognized as a component of other income, net in the consolidated statements of operations and comprehensive
loss. We use the Black-Scholes-Merton option-pricing model to estimate the fair value of the warrants. Offering costs associated with
the issuance of warrant liabilities are allocated on a relative basis and expensed as incurred. These warrants are now convertible into
Ordinary Shares.
Revenue
Recognition
During
the six months ended June 30, 2024, Notable’s central revenue generating activities and performance obligations consisted of performing
diagnostic services using its proprietary platform that was utilized by entities primarily engaged in their own research and development
efforts to identify therapeutic combinations in a more targeted and efficient method of drug discovery. These activities do not represent
its major and ongoing central operations.
Notable
recognizes revenue from diagnostic services in the amount that reflects the consideration that it expects to be entitled as Notable performs
its obligation under a contract with a customer by processing diagnostic tests on laboratory samples and making the test results available
to its customers. Revenue is recorded considering a five-step revenue recognition model that includes identifying the contract with a
customer, identifying the performance obligations in the contract, determining the transaction price, allocating the transaction price
to the performance obligations, and recognizing revenue when, or as, an entity satisfies a performance obligation. Notable generally
has a contract or a purchase order from a customer with the specified required terms, including the number of diagnostic samples to be
performed. Notable has not received any advance payments for which there are any remaining performance obligations. Accordingly, no deferred
revenue is recorded as of June 30, 2024 and December 31, 2023. Notable has not recorded any contract assets as of June 30, 2024 and December
31, 2023 as Notable has not completed any performance obligations for which it has not been able to bill its customers. Material costs
of services revenue are recorded as costs of sales and immaterial costs of services are recorded in operating expenses.
In
accordance with FASB ASC 606, Revenue from Contracts with Customers, Notable recognizes revenue when it satisfies performance
obligations, by transferring promised goods or services to customers, in an amount that reflects the consideration to which Notable expects
to be entitled in exchange for fulfilling those performance obligations.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Not
required.
Item
4. Controls and Procedures.
Management’s
Evaluation of our Disclosure Controls and Procedures
Our
management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure
controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange
Act, as of June 30, 2024. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit
relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of June 30, 2024,
our Chief Executive Officer and Chief Financial Officer (our principal executive officer and principal financial officer, respectively)
concluded that, as of such date, our disclosure controls and procedures were effective.
Changes
in Internal Control over Financial Reporting
There
was no change in our internal control over financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act that
occurred during the quarter ended June 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal
control over financial reporting.
PART
II—OTHER INFORMATION
Item
1. Legal Proceedings
As
of the date of this Quarterly Report on Form 10-Q, we are not involved in any material legal proceedings. However, from time to time,
we could be subject to various legal proceedings and claims that arise in the ordinary course of our business activities. Regardless
of the outcome, legal proceedings can have an adverse impact on us because of defense and settlement costs, diversion of management resources
and other factors.
Item
1A. Risk Factors.
Please
refer to the Risk Factors in Part I, Item 1A of the Company’s Form 10-K for the year ended December 31, 2023. There have been no
material changes to such matters during the quarter ended June 30, 2024, except as follows:
We
are not in compliance with Nasdaq’s minimum bid price requirement and if we fail to regain compliance our ordinary shares would
be delisted, which could adversely affect the liquidity of our ordinary shares and our ability to raise additional capital.
On
July 17, 2024, we received a written notification (the “Notice”) from the Nasdaq Stock Market LLC (“Nasdaq”),
indicating that we were not in compliance with the minimum closing bid price requirement set forth in Nasdaq Rules for continued listing
on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities to maintain a minimum bid price of $1.00 per
share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price requirement exists if the deficiency continues
for a period of 30 consecutive business days. Based on the closing bid price of our ordinary shares for the 30 consecutive business days
from June 3, 2024, to July 16, 2024, we no longer meet the minimum bid price requirement.
The
Notice has no immediate effect on the listing of our ordinary shares on the Nasdaq Capital Market. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A),
we have been granted a 180-calendar-day compliance period, or until January 13, 2025, to regain compliance with the minimum bid price
requirement. During the compliance period, our ordinary shares will continue to be listed and traded on the Nasdaq Capital Market. To
regain compliance, the closing bid of our ordinary shares must meet or exceed $1.00 per share for a minimum of ten (10) consecutive business
days during the 180-calendar-day grace period.
In
the event we are not in compliance by January 13, 2025, we may be afforded a second 180-calendar-day grace period. To qualify, we would
be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards
for the Nasdaq Capital Market, with the exception of the minimum bid price requirement.
If
we do not regain compliance within the allotted compliance period(s), including any extensions that may be granted by Nasdaq, Nasdaq
will provide notice that our ordinary shares will be subject to delisting. Under such circumstances, we would have the right to appeal
a determination to delist our ordinary shares, and our ordinary shares would remain listed on the Nasdaq Capital Market until the completion
of the appeal process.
We
intend to monitor our closing bid price for our ordinary shares between now and January 13, 2025, and will consider any such available
options to resolve our non-compliance with the minimum bid price requirement as may be necessary. No determination regarding our response
has been made at this time. There can be no assurance that we will be able to regain compliance with the minimum bid price requirement
or will otherwise be in compliance with other Nasdaq listing criteria.
If
we fail to satisfy any other continued listing requirements of Nasdaq, such as the corporate governance requirements, Nasdaq may also
take steps to delist our ordinary shares. Such a delisting would likely have a negative effect on the price of our ordinary shares and
would impair your ability to sell or purchase our ordinary shares when you wish to do so. In the event of a delisting, we can provide
no assurance that any action taken by us to restore compliance with listing requirements would allow our ordinary shares to become listed
again, stabilize the market price or improve the liquidity of our ordinary shares, prevent our ordinary shares from dropping below the
Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
applicable.
Item
5. Other Information.
On August
9, 2024, Notable Labs, Inc. a wholly-owned subsidiary of Notable Labs, Ltd. (“Notable”) entered into a Second Amended and
Restated Employment Agreement with Thomas A. Bock, Notable’s Chief Executive Officer (the “2024 CEO Agreement”). The
2024 CEO Agreement is in accordance with the economic terms previously approved pursuant to Israeli law by Notable’s shareholders
at the special meeting of shareholders on March 22, 2024 and superseded and replaced Dr. Bock’s prior employment agreement dated
April 30, 2021.
The 2024 CEO Agreement has no fixed term, has an
effective date of April 1, 2024, and includes the following terms and conditions: (i) Dr. Bock’s salary was increased to $525,000
and may be adjusted from time to time thereafter at the discretion of Notable’s Board of Directors (the “Board”), (ii)
Dr. Bock shall be entitled to receive a target annual bonus equivalent to sixty-five percent (65%) of his annual base salary (as in effect
from time to time), which annual bonus shall be awarded, if at all, at the discretion of the Board based upon metrics to be mutually agreed
upon by Dr. Bock and the Board, (iii) Dr. Bock will be eligible for short-term and long-term incentive compensation, including equity
compensation, which will be determined by the Board and Notable’s shareholders, and (iv) reimbursement for travel expenses from
Dr. Bock’s residence in San Diego, California to Notable’s business location in Foster City, CA, subject to a maximum of one
thousand five hundred dollars ($1,500) per week and reimbursement of all other ordinary and reasonable out-of-pocket business expenses.
Notwithstanding the foregoing, with respect to calendar
year 2024, Dr. Bock’s annual cash bonus earned, if any, shall be prorated by multiplying it by a fraction, the numerator of which
equals the number of days that he was employed by Notable Labs, Inc. from April 1, 2024 through the end of the 2024 calendar year and
the denominator of which equals 365.
In the event that Dr. Bock’s employment is
terminated by Notable Labs, Inc. other than for Cause (as defined in the 2024 CEO Agreement), or by Dr. Bock for Good Reason (as defined
in the 2024 CEO Agreement), then, in addition to any accrued but unpaid amounts and the annual bonus (if deemed earned), Dr. Bock shall
receive: (i) a lump sum payment equal to his then-current annual base salary, less all customary and required taxes and employment-related
deductions, commencing on the first payroll date following the date on which he provides a customary release and such release becomes
effective and non-revocable but not more than seventy (70) days after the effective date of termination, (ii) continued medical insurance
coverage with the premium for such benefits paid by Notable Labs, Inc. until the earlier to occur of (A) twelve (12) months following
Dr. Bock’s termination date, or (B) the date he becomes eligible for medical benefits with another employer.
In the event that a Change of Control of Notable
(as defined in the 2024 CEO Agreement) occurs and within a period of one (1) year following the Change of Control, or ninety (90) days
preceding the earlier to occur of a Change of Control or the execution of a definitive agreement the consummation of which would result
in a Change of Control, Dr. Bock’s employment is terminated other than for Cause, or Dr. Bock terminates his employment for Good
Reason, then, in addition to any accrued but unpaid amounts and the annual bonus (if deemed earned), Dr. Bock shall receive: (i) a lump
sum payment equal to his then-current annual base salary, less all customary and required taxes and employment-related deductions, commencing
on the first payroll date following the date on which he provides a customary release and such release becomes effective and non-revocable
but not more than seventy (70) days after the effective date of termination, (ii) on the date of termination of his employment, Dr. Bock
shall become fully vested in any and all outstanding equity awards with a time-based vesting schedule outstanding as of the date of his
termination and his time to exercise any time-based equity interests shall be extended for twelve (12) months following the termination
date, and (iii) continued medical insurance coverage with the premium for such benefits paid by Notable Labs, Inc. until the earlier to
occur of (A) twelve (12) months following Dr. Bock’s termination date, or (B) the date he becomes eligible for medical benefits
with another employer.
The 2024 CEO Agreement also obligates Dr. Bock to
continue to abide by the terms of his proprietary inventions and assignment agreement, which remains in effect.
Item
6. Exhibits.
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.
|
NOTABLE
LABS, LTD. |
|
|
|
Date:
August 14, 2024 |
By: |
/s/
Thomas A. Bock |
|
|
Thomas
A. Bock |
|
|
Chief
Executive Officer
(Principal
Executive Officer) |
|
|
|
Date:
August 14, 2024 |
By: |
/s/
Scott A. McPherson |
|
|
Scott
A. McPherson |
|
|
Chief
Financial Officer
(Principal
Financial and Accounting Officer) |
Exhibit
10.1
SECOND
AMENDED AND RESTATED EMPLOYMENT AGREEMENT
This
Second Amended and Restated Employment Agreement (this “Agreement”) is made and entered into on August 9, 2024 and
effective as of April 1, 2024 (the “Effective Date”) by and between Notable Labs, Inc., a Delaware corporation (the
“Notable”) and Thomas Bock (“Executive”) and supersedes in all respects the Amended and Restated
Employment Agreement between Executive and Notable dated as of April 30, 2021.
Recitals
A.The
Company wishes to retain the services of Executive from and after the date hereof on the terms and subject to the conditions hereinafter
set forth.
B.Executive
is willing to make his services available to the Company from and after the date hereof on the terms and subject to the conditions hereinafter
set forth.
Agreement
NOW,
THEREFORE, in consideration of the promises and mutual covenants set forth herein, the parties agree as follows:
1.
Roles and Duties. During the Term (as hereinafter defined) and Executive’s employment hereunder, subject to the terms and conditions
of this Agreement, Executive shall serve as Notable’s Chief Executive Officer and the Chief Executive of Notable Labs, Ltd., a
company organized under the laws of the State of Israel (“Parent” and together with Notable, the “Company”)
reporting to Parent’s Board of Directors (the “Board”). In such positions, Executive shall have such duties
and responsibilities as are reasonably determined by the Board and are consistent with the duties customarily performed by a Chief Executive
Officer of a similarly situated company. Executive accepts such employment upon the terms and conditions set forth in this Agreement,
and agrees to perform such duties and discharge such responsibilities to the best of Executive’s ability. During Executive’s
employment, Executive shall devote all of Executive’s business time and energies to the business and affairs of the Company. Nothing
in this Agreement shall preclude Executive from (i) performing services for such other companies as the Company may designate or permit;
(ii) serving, with the prior written consent of the Board, which consent shall not be unreasonably withheld, as a member of the boards
of directors or advisory boards (or their equivalents in the case of a non-corporate entity) of non- competing businesses or charitable,
educational or civic organizations; (iii) engaging in charitable activities and community affairs; and (iv) managing Executive’s
personal investments and affairs; provided, however, that the activities set out in clauses (i), (ii), (iii) and (iv) shall be limited
by Executive so as not to materially interfere, individually or in the aggregate, with the performance of Executive’s duties and
responsibilities to the Company.
2.
Term of Employment.
(a)
Term. Executive’s employment under this Agreement shall commence upon the Effective Date and subject to the terms in this
Agreement, shall continue until terminated by either party (such term of employment referred to herein as the “Term”).
(b)
Termination. Notwithstanding anything else contained in this Agreement, Executive’s employment shall terminate upon the
earliest to occur of the following:
(i)
Death. Immediately upon Executive’s death.
(ii)
Termination by the Company.
(A)
If because of Executive’s Disability (as defined below in Section 2(c)), written notice by either Notable or Parent to Executive
that Executive’s employment is being terminated as a result of Executive’s Disability, which termination shall be effective
on the date of such notice or such later date as specified in writing by either Notable or Parent;
(B)
If for Cause (as defined below in Section 2(d)), written notice by either Notable or Parent to Executive that Executive’s employment
is being terminated for Cause, which termination shall be effective on the date of such notice or such later date as specified in writing
by either Notable or Parent, provided that if prior to the effective date of such termination Executive has cured the circumstances
giving rise to the Cause (if capable of being cured as provided in Section 2(d)), then such termination shall not be effective; or
(C)
If by either Notable or Parent for reasons other than under Sections 2(b)(ii)(A) or (B), written notice by either Notable or Parent to
Executive that Executive’s employment is being terminated, which termination shall be effective thirty (30) days after the date
of such notice.
(iii)
Termination by Executive.
(A)
If for Good Reason (as defined below in Section 2(e)), written notice by Executive to either Notable or Parent that Executive is terminating
Executive’s employment for Good Reason and that sets forth the factual basis supporting the alleged Good Reason, which termination
shall be effective thirty (30) days after the date of such notice; provided that if before the effective date of such termination
either Notable or Parent has cured the circumstances giving rise to the Good Reason if capable of being cured as provided in Section
2(e), then such termination shall not be effective; or
(B)
If without Good Reason, written notice by Executive to either Notable or Parent that Executive is terminating Executive’s employment,
which termination shall be effective no fewer than thirty (30) days after the date of such notice unless waived, in whole or in part,
by either Notable or Parent.
Notwithstanding
anything in this Section 2(b), either Notable or Parent may, under the conditions set forth in Section 2(b)(ii)(B), terminate Executive’s
employment for Cause before the effective date of any other termination as provided in this Section 2; provided that before the
effective date of such for-Cause termination Executive has cured the circumstances giving rise to the Cause (if capable of being cured
as provided in Section 2(d)), then such termination shall not be effective.
(c)
“Disability”. For purposes of this Agreement, “Disability” shall mean Executive’s incapacity or
inability to perform Executive’s duties and responsibilities by reason of a medically determinable mental or physical impairment
for one hundred twenty (120) days or more within any one (1) year period (cumulative or consecutive), which impairment can reasonably
be expected to result in death or can be expected to last for a continuous period of not less than six (6) months. The determination
that Executive is disabled as provided by this Agreement, if disputed by the parties, shall be resolved by a physician reasonably satisfactory
to Executive and either Notable or Parent, at the Company’s expense, and the determination of such physician shall be final and
binding upon both Executive and the Company. Executive consents to such examination and consultation by a physician. The Company will
keep all information it receives as a result of such inquiry and determination confidential and will not use it for any purpose other
than in connection with exercising its rights under this Agreement.
(d)
“Cause”. As used herein, “Cause” shall mean: (i) Executive’s conviction of (A) a felony or (B) any
misdemeanor involving moral turpitude, deceit, dishonesty or fraud; (ii) Executive’s willful failure or refusal to comply with
lawful directions of the Board in performing Executive’s duties, which failure or refusal continues for more than fourteen (14)
business days after written notice is given to Executive by either Notable or Parent, which notice sets forth in reasonable detail the
nature of such failure or refusal; (iii) willful and material breach by Executive of a material Company policy or provision of this Agreement,
provided Executive does not cure such breach within fourteen (14) business days after receiving written notice of the alleged breach
if such breach is curable; or (iv) misconduct by Executive that materially damages the Company’s or any of its affiliates’
reputation. Except in the case of (ii) above, it is not necessary that the Company’s finding of Cause occur before Executive’s
termination of service. If the Company determines, after Executive’s termination of service, that before Executive’s termination,
Executive engaged in conduct which would constitute “Cause” (other than pursuant to (ii) above), then Executive shall have
no right to any benefit or compensation under this Agreement, except as required by law.
(e)
“Good Reason”. As used herein, “Good Reason” shall mean: (i) a material diminution in Executive’s
duties, authority or responsibilities from those described in Section 1; (ii) a material reduction in Executive’s Annual Base Salary;
(iii) willful and material breach by the Company of its covenants and/or obligations under this Agreement; or (iv) a relocation of Executive’s
principal place of business to a place that requires Executive to travel more than an additional hour of travel time from Executive’s
current principal place of residence or Company-required relocation of Executive’s principal place of residence in Rancho Santa
Fe, California; provided that, in each of the foregoing clauses (i) through (iv) (A) Executive provides either Notable or Parent with
a written notice that Executive intends to terminate Executive’s employment hereunder for one of the grounds set forth in this
Section 2(e) within sixty (60) days of such ground occurring, (B) if such ground is capable of being cured, Company has failed to cure
such ground within a period of thirty (30) days from the date of such written notice, and (C) Executive terminates by written notice
Executive’s employment within sixty-five (65) days from the date that Executive provides the notice contemplated by clause (A)
of this Section 2(e). For purposes of clarification, the above-listed conditions shall apply separately to each occurrence of Good Reason,
and failure to adhere to such conditions in the event of Good Reason shall not disqualify Executive from asserting Good Reason for any
other or later occurrence of Good Reason. For purposes of this Agreement, “Good Reason” shall be interpreted in a manner,
and limited to the extent necessary, so that it shall not cause adverse tax consequences for either party with respect to Section 409A
(“Section 409A”) of the Internal Revenue Code of 1986, as amended (the “Code”) and any successor statute,
regulation and guidance thereto.
3.
Compensation.
(a)
Annual Base Salary. During his employment, Notable shall pay Executive an initial base salary at the annual rate of Five Hundred
Twenty-Five Thousand Dollars ($525,000) (as in effect from time to time, the “Annual Base Salary”) pro-rated for any
partial year of employment during the Term, subject to increases as determined by the Board in accordance with applicable law. The Annual
Base Salary shall be payable in substantially equal periodic installments in accordance with Notable’s payroll practices as in
effect from time to time. Notable shall deduct from each such installment all amounts required to be deducted or withheld under applicable
law or under any employee benefit plan in which Executive participates. On at least an annual basis, the Company shall review Executive’s
Annual Base Salary and consider an increase in its sole discretion.
(b)
Annual Bonus. Executive shall be entitled to receive a target annual bonus equivalent to sixty-five percent (65%) of Executive’s
Annual Base Salary (as in effect from time to time, the “Annual Bonus”), which Annual Bonus shall be awarded, if at
all, at the discretion of the Board based upon metrics to be mutually agreed upon by Executive and the Board. The Annual Bonus shall
be determined at the conclusion of each calendar year and shall be paid, if at all, no later than March 31 of the year following the
year to which the Annual Bonus relates. Notwithstanding the foregoing, with respect to calendar year 2024, Executive’s annual cash
bonus earned, if any, shall be prorated by multiplying it by a fraction, the numerator of which equals the number of days that Executive
was employed by the Company from the Effective Date through the end of the 2024 calendar year and the denominator of which equals 365.
(c)
Equity Awards. In connection with Executive’s employment, during the Term, Executive may be eligible to receive an annual
equity incentive award under the Parent’s equity-based compensation plan(s) as determined by the Board and Parent’s shareholders.
(d)
Reimbursement of Expenses. The Company has agreed that Executive may maintain his residence in San Diego, California and, Notable
has agreed to reimburse Executive for (i) travel expenses from Executive’s residence in San Diego, California to the Company’s
business location in Foster City, CA, subject to a maximum of one thousand five hundred dollars ($1,500) per week and upon presentation
of usual and customary receipts demonstrating same, and (ii) all other ordinary and reasonable out-of-pocket business expenses incurred
by Executive in furtherance of the Company’s business in accordance with the Company’s policies as in effect from time to
time. Executive must submit any request for reimbursement no later than ninety (90) days following the date that such business expense
is incurred. All reimbursements provided under this Agreement shall be made or provided in accordance with the requirements of Section
409A of the Code including, where applicable, the requirement that (i) any reimbursement is for expenses incurred during Executive’s
lifetime (or during a shorter period of time specified in this Agreement); (ii) the amount of expenses eligible for reimbursement during
a calendar year may not affect the expenses eligible for reimbursement in any other calendar year; (iii) the reimbursement of an eligible
expense shall be made no later than the last day of the calendar year following the year in which the expense is incurred; and (iv) the
right to reimbursement or in-kind benefits is not subject to liquidation or exchange for another benefit.
(e)
Indemnification. Executive shall be entitled to indemnification with respect to Executive’s services pursuant to Israeli
law, the terms and conditions of Parent’s articles of association and/or memorandum of association and under California law, to
the greatest extent each of them may provide. Executive shall be entitled to coverage under the Company’s Directors’ and
Officers’ (“D&O”) insurance policies that it may hold now or in the future to the same extent and in the
same manner (i.e., subject to the same terms and conditions) to which the Company’s other executive officers are entitled to coverage
under any of the Company’s D&O insurance policies.
4.
Payments Upon Termination.
(a)
Definition of Accrued Obligations. For purposes of this Agreement, “Accrued Obligations” means: (i) the portion of
Executive’s Annual Base Salary that has accrued before any termination of Executive’s employment with the Company and has
not yet been paid; and (ii) the amount of any expenses properly incurred by Executive on behalf of the Company before any such termination
and not yet reimbursed. Executive’s entitlement to any other compensation or benefit under any Company plan shall be governed by
and determined in accordance with the terms of such plans (if any), except as otherwise specified in this Agreement.
(b)
Termination for Cause, Without Good Reason by Executive, or for Disability or Death. If Executive’s employment is terminated
by the Company for Cause, by Executive without Good Reason, or for Disability or death, then Notable shall pay the Accrued Obligations
to Executive within the time provided by law for terminated employees and the Company shall have no further obligations to Executive
under this Agreement.
(c)
Termination by the Company Without Cause or by Executive For Good Reason. In the event that Executive’s employment is terminated
by the Company other than for Cause, or by Executive for Good Reason, then, in addition to the Accrued Obligations and the Annual Bonus
(if deemed earned), Executive shall receive the following, subject to the terms and conditions described in Section 4(e) (including Executive’s
execution of the Release (as defined herein)):
(i)
Severance Payments. A lump sum payment equal to Executive’s then-current Annual Base Salary, less all customary and required
taxes and employment-related deductions, in accordance with the Company’s normal payroll practices (provided such payments shall
be made at least monthly), commencing on the first payroll date following the date on which the Release required by Section 4(e) becomes
effective and non-revocable, but not more than seventy (70) days after the effective date of termination from employment; provided,
that if the seventieth (70th) day falls in the calendar year following the year during which the termination or separation
from service occurred, then the payments will commence in such subsequent calendar year; provided further that if such payments commence
in such subsequent year, the first such payment shall be a lump sum in an amount equal to the payments that would have come due since
Employee’s separation from service.
(ii)
Benefits Payments. Upon completion of appropriate forms and subject to applicable terms and conditions under the Consolidated
Omnibus Budget Reconciliation Act of 1985, as amended (“COBRA”), Notable shall continue to provide Executive medical
insurance coverage to the same extent that such insurance continues to be provided to Executive at the time of Executive’s termination
with the premium for such benefits paid by Notable (the “COBRA Payment”), until the earlier to occur of: (i) twelve
(12) months following Executive’s termination date, or (ii) the date Executive becomes eligible for medical benefits with another
employer. Notwithstanding the foregoing, if Executive’s COBRA Payment would cause the applicable group health plan to be discriminatory
and, therefore, result in adverse tax consequences to Executive, Notable shall, in lieu of the COBRA Payment, provide Executive with
an equivalent monthly cash payment, minus deduction of all amounts required to be deducted or withheld under applicable law, for any
period of time Executive is eligible to receive the COBRA Payment. Executive shall bear full responsibility for applying for COBRA continuation
coverage and Notable shall have no obligation to provide Executive such coverage if Executive fails to elect COBRA benefits in a timely
fashion.
Payment
of the above described severance payments and benefits are expressly conditioned on Executive’s execution without revocation of
the Release and return of Company property under Section 6.
(d)
Termination by the Company Without Cause or by Executive For Good Reason Following a Change of Control. In the event that a Change
of Control of Parent (as defined below) occurs and within a period of one (1) year following the Change of Control, or ninety (90) days
preceding the earlier to occur of a Change of Control or the execution of a definitive agreement the consummation of which would result
in a Change of Control, Executive’s employment is terminated other than for Cause, or Executive terminates Executive’s employment
for Good Reason, then, in addition to the Accrued Obligations and the Annual Bonus (if deemed earned), Executive shall receive the following,
subject to the terms and conditions described in Section 4(e) (including Executive’s execution of the Release):
(i)
Lump Sum Severance Payment. A lump sum payment equal to the Executive’s then-current Annual Base Salary, less all customary
and required taxes and employment-related deductions, paid on the first payroll date following the date on which the Release required
by Paragraph 4(e) becomes effective and non-revocable, but not after seventy (70) days following the effective date of termination from
employment.
(ii)
Equity Acceleration. On the date of termination of Executive’s employment, Executive shall become fully vested in any and
all outstanding equity awards with a time-based vesting schedule outstanding as of the date of Executive’s termination (including
any equity awards granted prior to the date hereof) and this provision shall supersede any acceleration provision contained in any equity
award agreement or option agreement providing for a time-based vesting schedule. In addition, Executive’s time to exercise any
time-based equity interests shall be extended for twelve (12) months following the termination date, it being understood that in the
event Executive exercises any option award more than three months post-termination the option award will be a nonqualified stock option.
(iii)
Benefit Payments. Upon completion of appropriate forms and subject to applicable terms and conditions under COBRA, Notable shall
continue to provide Executive medical insurance coverage to the same extent that such insurance continues to be provided to Executive
at the time of Executive’s termination with the cost of the premium for such benefits paid by Notable, until the earlier to occur
of: (i) twelve (12) months following Executive’s termination date, or (ii) the date Executive becomes eligible for medical benefits
with another employer. Notwithstanding the foregoing, if Executive’s COBRA Payment would cause the applicable group health plan
to be discriminatory and, therefore, result in adverse tax consequences to Executive, Notable shall, in lieu of the COBRA Payment, provide
Executive with an equivalent monthly cash payment, minus deduction of all amounts required to be deducted or withheld under applicable
law, for any period of time Executive is eligible to receive the COBRA Payment. Executive shall bear full responsibility for applying
for COBRA continuation coverage and Notable shall have no obligation to provide Executive such coverage if Executive fails to elect COBRA
benefits in a timely fashion.
Payment
of the above-described severance payments and benefits are expressly conditioned on Executive’s execution without revocation of
the Release and return of Company property under Section 4(e) and Executive’s resignation of any Board positions or seats that
Executive holds with Parent and any affiliates. In the event that Executive is eligible for the severance payments and benefits under
this Section 4(d), Executive shall not be eligible for any of the severance payments and benefits as provided in Section 4(c).
As
used herein, a “Change of Control” shall mean the occurrence of any of the following events: (i) Ownership. Any “Person”
(as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended) becomes the “Beneficial Owner”
(as defined in Rule 13d-3 under said Act), directly or indirectly, of securities of Parent representing fifty percent (50%) or more of
the total voting power represented by Parent’s then outstanding voting securities (excluding for this purpose any such voting securities
held by Parent, or any affiliate, parent or subsidiary of Parent, or by any employee benefit plan of Parent) pursuant to a transaction
or a series of related transactions; or (ii) Merger/Sale of Assets. (A) A merger or consolidation of Parent whether or not approved
by the Board, other than a merger or consolidation which would result in the voting securities of Parent outstanding immediately prior
thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity
or the parent of such corporation) at least fifty percent (50%) of the total voting power represented by the voting securities of Parent
or such surviving entity or parent of such corporation, as the case may be, outstanding immediately after such merger or consolidation;
(B) or Parent’s shareholders approve an agreement for the sale or disposition by the Parent of all or substantially all of Parent’s
assets; provided that, following the occurrence of any such merger or consolidation that does not constitute a Change of Control, the
term “Parent” shall thereafter refer to Parent, such surviving entity or parent, as the case may be.
(e)
Execution of Release of Claims. Notable shall not be obligated to pay Executive any of the severance payments or benefits described
in this Section 4 unless and until Executive has executed (without revocation) a release of claims as described below (the “Release”).
The Release shall contain reasonable and customary provisions including a general release of claims against the Company and its affiliated
entities and each of their officers, directors and employees as well as provisions concerning non-disparagement, confidentiality, cooperation
and the like. The Release must be provided to Executive not later than fifteen (15) days following the effective date of termination
of Executive’s employment by the Company and executed by Executive and returned to the Company within sixty (60) days after such
effective date. If Executive fails or refuses to return the Release within such 60-day period, Executive’s severance payments and
benefits to be paid hereunder shall be forfeited. If the Company does not provide Executive with such a release within thirty (30) days
of termination, payments under this Section 4 shall be due and payable without the need for execution of such a release.
(f)
No Other Payments or Benefits Owing. Except as expressly set forth, the payments and benefits set forth in this Section 4: (a)
shall be the sole amounts owing to Executive upon termination of Executive’s employment for the reasons set forth above, and Executive
shall not be eligible for any other payments or other forms of compensation or benefits; (b) shall be the sole remedy, if any, available
to Executive in the event that Executive brings any claim against the Company relating to the termination of Executive’s employment
under this Agreement; and (c) shall not be subject to set-off by the Company or any obligation on the part of Executive to mitigate or
to offset compensation earned by Executive in other pursuits after termination of employment, other than as specified with respect medical
benefits provided by another employer.
5.
Proprietary Information. Executive has previously executed a Proprietary Inventions and Assignment Agreement, which shall continue
to remain in full effect.
6.
Property and Records. Upon the termination of Executive’s employment for any reason or for no reason, or if the Company otherwise
requests, Executive shall: (a) return to Company all tangible business information and copies thereof (regardless how such confidential
information or copies are maintained), and (b) deliver to the Company any property of the Company which may be in Executive’s possession,
including, but not limited to, devices, smart phones, laptops, cell phones (the foregoing, “electronic devices”), products,
materials, memoranda, notes, records, reports or other documents or photocopies of the same. Executive may retain copies of any exclusively
personal data contained in or on the Company-owned electronic devices returned to the Company pursuant to the foregoing. Executive understands
and agrees that Company property belongs exclusively to the Company, it should be used for Company business, and Executive has no reasonable
expectation of privacy on any Company property or with respect to any information stored thereon.
7.
Cooperation. During and after Executive’s employment, Executive shall fully cooperate with the Company to the extent reasonable
in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of
the Company (other than claims directly or indirectly against Executive) which relate to events or occurrences that transpired while
Executive was employed by the Company. Executive’s cooperation in connection with such claims or actions shall include, but not
be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company
at mutually convenient times. During and after Executive’s employment, Executive also shall fully cooperate with the Company to
the extent reasonable in connection with any investigation or review of any federal, state or local regulatory authority as any such
investigation or review relates to events or occurrences that transpired while Executive was employed by the Company. The Company shall
reimburse Executive for all reasonable out-of-pocket expenses incurred by Executive in connection with Executive’s performance
of obligations pursuant to this Section 7.
8.
Code Section 280G. If any payment or benefit Executive would receive under this Agreement, when combined with any other payment or
benefit Executive receives for his services to the Company (for purposes of this section, a “Payment”) would: (i)
constitute a “parachute payment” within the meaning of Section 280G the Code; and (ii) but for this sentence, be subject
to the excise tax imposed by Section 4999 of the Code (the “Excise Tax”), then such Payment shall be either: (A) the full
amount of such Payment; or (B) such lesser amount (with cash payments being reduced before stock option compensation) as would result
in no portion of the Payment being subject to the Excise Tax, whichever of the foregoing amounts, taking into account the applicable
federal, state and local employments taxes, income taxes, and the Excise Tax, results in Executive’s receipt, on an after-tax basis,
of the greater amount of the Payment notwithstanding that all or some portion of the Payment may be subject to the Excise Tax.
9.
Section 409A. Notwithstanding any provision of this Agreement to the contrary, if Executive is a “specified employee”
as defined in Section 409A, solely to the extent required to avoid the imposition of additional taxes on Executive under Section 409A,
Executive shall not be entitled to any payments or benefits the right to which provides for a “deferral of compensation”
within the meaning of Section 409A, and whose payment or provision is triggered by Executive’s termination of employment (whether
such payments or benefits are provided to Executive under this Agreement or under any other plan, program or arrangement of the Company),
until (and any portion or installments of any payments or benefits suspended hereby shall be paid in a lump sum on) the earlier of (a)
the date which is the first business day following the six (6)-month anniversary of Executive’s “separation from service”
(within the meaning of Section 409A), but in any event, no later than March 15th of the following year, or (b) Executive’s date
of death, and such payments or benefits that, if not for the six (6) month delay described herein, would be due and payable prior to
such date shall be made or provided to Executive on such date. The Company shall make the determination as to whether Executive is a
“specified employee” in good faith in accordance with its general procedures adopted in accordance with Section 409A and,
at the time of Executive’s “separation from service” will notify Executive whether or not he is a “specified
employee.”
10.
General.
(a)
Notices. Except as otherwise specifically provided, any notice required or permitted by this Agreement shall be in writing and
shall be delivered as follows with notice deemed given as indicated: (i) by personal delivery when delivered personally; (ii) by overnight
courier with tracking upon written verification of receipt; (iii) by electronic mail transmission provided acknowledgment of receipt
of electronic transmission is provided; or (iv) by certified or registered mail, return receipt requested, upon verification of receipt.
Notices to Executive shall be sent to the last known address in the Company’s records or such other address as Executive may specify
in writing. Notices to the Company shall be sent to the Notable Labs, Ltd. Chairman of the Board.
(b)
Modifications and Amendments. The terms and provisions of this Agreement may be modified or amended only by written agreement
executed by the parties.
(c)
Waivers and Consents. The terms and provisions of this Agreement may be waived, or consent for the departure therefrom granted,
only by a written document executed by the party entitled to the benefits of such terms or provisions. No such waiver or consent shall
be deemed to be or shall constitute a waiver or consent with respect to any other terms or provisions of this Agreement, whether or not
similar. Each such waiver or consent shall be effective only in the specific instance and for the purpose for which it was given and
shall not constitute a continuing waiver or consent.
(d)
Assignment. The Company may assign its rights and obligations hereunder to any person or entity that succeeds to all or substantially
all of the Company’s business. Executive may not assign Executive’s rights and obligations under this Agreement without the
prior written consent of the Company.
(e)
Governing Law/Dispute Resolution. This Agreement and the rights and obligations of the parties hereunder shall be construed in
accordance with and governed by the law of the State of California without giving effect to the conflict of law principles thereof. Any
legal action or proceeding with respect to this Agreement shall be brought pursuant to the Arbitration Agreement attached hereto as Exhibit
A and executed by and between Executive and the Company simultaneously herewith.
(f)
Headings and Captions. The headings and captions of the various subdivisions of this Agreement are for convenience of reference
only and shall in no way modify or affect the meaning or construction of any of its terms or provisions.
(g)
Entire Agreement. This Agreement, together with the other agreements specifically referenced, embodies the entire agreement and
understanding between the parties with respect to the subject matter of this Agreement and supersedes all previous oral or written agreements
and understandings relating to the subject matter hereof. No statement, representation, warranty, covenant or agreement of any kind not
expressly set forth in this Agreement shall affect, or be used to interpret, change or restrict, the express terms and provisions of
this Agreement.
(h)
Counterparts. This Agreement may be executed in two or more counterparts, and by different parties on separate counterparts, each
of which shall be deemed an original, but all of which together shall constitute one and the same instrument. For all purposes an electronic
signature shall be treated as an original.
[SIGNATURE
PAGE FOLLOWS]
IN
WITNESS WHEREOF, the parties have executed this Agreement as of the date first written above.
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NOTABLE
LABS, INC. |
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By:
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/s/
Thomas I.H. Dubin |
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Name: |
Thomas
Dubin |
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Title: |
Authorized
Signatory |
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THOMAS
BOCK |
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/s/ Thomas Bock |
EXHIBIT
A
Arbitration
Agreement
(attached)
ARBITRATION
AGREEMENT
THIS
ARBITRATION AGREEMENT (this “Agreement”) is entered into as of August 9, 2024, by and between Notable Labs, Inc. (the
“Company”) and Thomas Bock (“Bock”).
RECITALS
WHEREAS,
the Company and Bock are parties to that certain Second Amended and Restated Employment Agreement, dated as of August 9, 2024 (as the
same may be amended, the “Employment Agreement”); and
WHEREAS,
the Employment Agreement provides that any legal action or proceeding with respect to the Employment Agreement shall be brough pursuant
to this Agreement.
NOW,
THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:
1.
Arbitration. IN CONSIDERATION OF BOCK’S EMPLOYMENT WITH THE COMPANY, ITS PROMISE TO ARBITRATE ALL EMPLOYMENT-RELATED
DISPUTES, AND BOCK’S RECEIPT OF THE COMPENSATION, PAY RAISES, AND OTHER BENEFITS PAID TO BOCK BY THE COMPANY, AT PRESENT AND IN
THE FUTURE, BOCK AGREES THAT, TO THE FULLEST EXTENT ALLOWED AND ENFORCEABLE UNDER APPLICABLE LAW, ANY AND ALL CONTROVERSIES, CLAIMS,
OR DISPUTES WITH ANYONE (INCLUDING THE COMPANY AND ANY EMPLOYEE, OFFICER, DIRECTOR, SHAREHOLDER, OR BENEFIT PLAN OF THE COMPANY, IN THEIR
CAPACITY AS SUCH OR OTHERWISE), ARISING OUT OF, RELATING TO, OR RESULTING FROM BOCK’S EMPLOYMENT WITH THE COMPANY OR THE TERMINATION
OF BOCK’S EMPLOYMENT WITH THE COMPANY, INCLUDING ANY BREACH OF THIS AGREEMENT, SHALL BE SUBJECT TO BINDING ARBITRATION UNDER THE
ARBITRATION PROVISIONS SET FORTH IN CALIFORNIA CODE OF CIVIL PROCEDURE SECTIONS 1280 THROUGH 1294.2 (THE “CCP ACT”),
AND PURSUANT TO CALIFORNIA LAW. THE FEDERAL ARBITRATION ACT SHALL CONTINUE TO APPLY WITH FULL FORCE AND EFFECT NOTWITHSTANDING THE APPLICATION
OF PROCEDURAL RULES SET FORTH IN THE CCP ACT. DISPUTES THAT BOCK AGREES TO ARBITRATE, AND THEREBY AGREES TO WAIVE ANY RIGHT TO A TRIAL
BY JURY, INCLUDE ANY STATUTORY CLAIMS UNDER LOCAL, STATE, OR FEDERAL LAW, INCLUDING, BUT NOT LIMITED TO, CLAIMS UNDER TITLE VII OF THE
CIVIL RIGHTS ACT OF 1964, THE AMERICANS WITH DISABILITIES ACT OF 1990, THE AGE DISCRIMINATION IN EMPLOYMENT ACT OF 1967, THE OLDER WORKERS
BENEFIT PROTECTION ACT, THE SARBANES-OXLEY ACT, THE WORKER ADJUSTMENT AND RETRAINING NOTIFICATION ACT, THE FAIR LABOR STANDARDS ACT,
THE CALIFORNIA FAIR EMPLOYMENT AND HOUSING ACT, THE FAMILY AND MEDICAL LEAVE ACT, THE CALIFORNIA FAMILY RIGHTS ACT, THE CALIFORNIA LABOR
CODE, CLAIMS OF HARASSMENT, DISCRIMINATION, AND WRONGFUL TERMINATION, AND ANY OTHER STATUTORY OR COMMON LAW CLAIMS; PROVIDED,
HOWEVER, THE COMPANY AND BOCK ACKNOWLEDGE THAT THE AGREEMENT TO ARBITRATE EMPLOYMENT-RELATED CLAIMS SHALL NOT PROHIBIT BOCK FROM
FILING A CASE RELATING TO SEXUAL HARASSMENT OR SEXUAL ASSAULT UNDER FEDERAL, TRIBAL OR STATE LAW AT BOCK’S ELECTION WHERE SUCH
DISPUTE OR CLAIM AROSE OR ACCRUED ON OR AFTER MARCH 3, 2022. NOTWITHSTANDING THE FOREGOING, BOCK UNDERSTANDS THAT NOTHING IN THIS AGREEMENT
CONSTITUTES A WAIVER OF MY RIGHTS UNDER SECTION 7 OF THE NATIONAL LABOR RELATIONS ACT. BOCK FURTHER UNDERSTANDS THAT THIS AGREEMENT TO
ARBITRATE ALSO APPLIES TO ANY DISPUTES THAT THE COMPANY MAY HAVE WITH HIM.
2.
Procedure. BOCK AGREES THAT ANY ARBITRATION WILL BE ADMINISTERED BY JUDICIAL ARBITRATION & MEDIATION SERVICES, INC. (“JAMS”),
PURSUANT TO ITS EMPLOYMENT ARBITRATION RULES & PROCEDURES (THE “JAMS RULES”), WHICH ARE AVAILABLE AT http://www.jamsadr.com/rules-employment-arbitration/.
THE ARBITRATOR SHALL BE A QUALIFIED INDIVIDUAL MUTUALLY SELECTED BY THE PARTIES. BOCK AGREES THAT THE ARBITRATOR SHALL HAVE THE POWER
TO DECIDE ANY MOTIONS BROUGHT BY ANY PARTY TO THE ARBITRATION, INCLUDING MOTIONS FOR SUMMARY JUDGMENT AND/OR ADJUDICATION, AND MOTIONS
TO DISMISS AND DEMURRERS, APPLYING THE STANDARDS SET FORTH UNDER THE CALIFORNIA CODE OF CIVIL PROCEDURE. BOCK AGREES THAT
THE ARBITRATOR SHALL ISSUE A WRITTEN DECISION ON THE MERITS. BOCK ALSO AGREES THAT THE ARBITRATOR SHALL HAVE THE POWER TO AWARD
ANY REMEDIES AVAILABLE UNDER APPLICABLE LAW, AND THAT THE ARBITRATOR SHALL AWARD ATTORNEYS’ FEES AND COSTS TO THE PREVAILING PARTY,
WHERE PROVIDED BY APPLICABLE LAW. BOCK AGREES THAT THE DECREE OR AWARD RENDERED BY THE ARBITRATOR
MAY BE ENTERED AS A FINAL AND BINDING JUDGMENT IN ANY COURT HAVING JURISDICTION THEREOF. BOCK UNDERSTANDS THAT THE COMPANY WILL
PAY FOR ANY ADMINISTRATIVE OR HEARING FEES CHARGED BY THE ARBITRATOR OR JAMS EXCEPT THAT BOCK SHALL PAY ANY FILING FEES ASSOCIATED WITH
ANY ARBITRATION THAT BOCK INITIATES, BUT ONLY SO MUCH OF THE FILING FEES AS BOCK WOULD HAVE INSTEAD PAID HAD BOCK FILED A COMPLAINT IN
A COURT OF LAW. BOCK AGREES THAT THE ARBITRATOR SHALL ADMINISTER AND CONDUCT ANY ARBITRATION IN ACCORDANCE WITH CALIFORNIA LAW, INCLUDING
THE CALIFORNIA CODE OF CIVIL PROCEDURE AND THE CALIFORNIA EVIDENCE CODE, AND THAT THE ARBITRATOR SHALL APPLY SUBSTANTIVE AND PROCEDURAL
CALIFORNIA LAW TO ANY DISPUTE OR CLAIM, WITHOUT REFERENCE TO RULES OF CONFLICT OF LAW. TO THE EXTENT THAT THE JAMS RULES CONFLICT WITH
CALIFORNIA LAW, CALIFORNIA LAW SHALL TAKE PRECEDENCE. BOCK AGREES THAT ANY ARBITRATION UNDER THIS
AGREEMENT SHALL BE CONDUCTED IN SAN MATEO COUNTY, CALIFORNIA.
3.
Remedy. EXCEPT AS PROVIDED BY THE CCP ACT AND THIS AGREEMENT, ARBITRATION SHALL BE THE SOLE, EXCLUSIVE, AND FINAL REMEDY FOR ANY
DISPUTE BETWEEN BOCK AND THE COMPANY. ACCORDINGLY, EXCEPT AS PROVIDED FOR BY THE CCP ACT AND THIS AGREEMENT, NEITHER BOCK NOR THE COMPANY
WILL BE PERMITTED TO PURSUE OR PARTICIPATE IN COURT ACTION REGARDING CLAIMS THAT ARE SUBJECT TO ARBITRATION.
4.
Administrative Relief. BOCK UNDERSTANDS THAT THIS AGREEMENT DOES NOT PROHIBIT HIM FROM PURSUING AN ADMINISTRATIVE CLAIM WITH A
LOCAL, STATE, OR FEDERAL ADMINISTRATIVE BODY OR GOVERNMENT AGENCY THAT IS AUTHORIZED TO ENFORCE OR ADMINISTER LAWS RELATED TO EMPLOYMENT,
INCLUDING, BUT NOT LIMITED TO, THE CALIFORNIA DEPARTMENT OF FAIR EMPLOYMENT AND HOUSING, THE EQUAL EMPLOYMENT OPPORTUNITY COMMISSION,
THE NATIONAL LABOR RELATIONS BOARD, OR THE WORKERS’ COMPENSATION BOARD. THIS AGREEMENT DOES, HOWEVER, PRECLUDE BOCK FROM PURSUING
COURT ACTION REGARDING ANY SUCH CLAIM, EXCEPT AS PERMITTED BY LAW.
5.
Class Action Waiver. TO THE FULLEST EXTENT PERMITTED BY LAW AND EXCEPT AS EXPRESSLY PROVIDED OTHERWISE HEREIN, ANY ARBITRATION
HEREUNDER SHALL PROCEED SOLELY ON AN INDIVIDUAL BASIS WITHOUT THE RIGHT FOR ANY CLAIMS TO BE ARBITRATED ON A CLASS OR COLLECTIVE ACTION
BASIS OR ON A BASIS INVOLVING CLAIMS BROUGHT IN A PURPORTED REPRESENTATIVE CAPACITY ON BEHALF OF OTHERS OR ANY GOVERNMENTAL BODY OR THE
PUBLIC. CLASS AND COLLECTIVE ACTIONS UNDER THIS DISPUTE RESOLUTION PROVISION ARE PROHIBITED, AND THE ARBITRATOR SHALL HAVE NO AUTHORITY
TO PROCEED ON SUCH BASIS. NO DISPUTE, CONTROVERSY, CLAIM OR ACTION BROUGHT IN ARBITRATION BY BOCK ARISING UNDER OR RELATING TO THIS AGREEMENT
OR OTHERWISE ARISING IN CONNECTION WITH OR RELATING TO BOCK’S EMPLOYMENT OR AFFILIATION WITH THE COMPANY SHALL PROCEED AS A CLASS
OR COLLECTIVE ACTION. ANY DISPUTES REGARDING THE VALIDITY AND ENFORCEABILITY OF THIS SECTION AND THE WAIVER HEREIN SHALL BE RESOLVED
EXCLUSIVELY BY THE DULY-APPOINTED ARBITRATOR, AND NOT BY A COURT OR OTHER GOVERNMENTAL OR ADMINISTRATIVE BODY. IN ANY CASE IN WHICH (1)
THE DISPUTE IS FILED AS A CLASS, COLLECTIVE, REPRESENTATIVE OR JOINT ACTION AND (2) THE ARBITRATOR FINDS ALL OR PART OF THE CLASS ACTION
WAIVER TO BE INVALID OR UNENFORCEABLE, THE CLASS, COLLECTIVE, REPRESENTATIVE OR JOINT ACTION TO THAT EXTENT MUST BE LITIGATED IN A COURT
WITH JURISDICTION AND VENUE AS PROVIDED, AND NOT IN ARBITRATION, BUT THE PORTION OF THE CLASS ACTION WAIVER THAT IS ENFORCEABLE SHALL
BE ENFORCED IN ARBITRATION, AND CLAIMS FALLING THEREUNDER SHALL BE ADJUDICATED IN ARBITRATION.
6.
Voluntary Nature of Agreement. BOCK ACKNOWLEDGES AND AGREES THAT HE IS EXECUTING THIS AGREEMENT VOLUNTARILY AND WITHOUT ANY DURESS
OR UNDUE INFLUENCE BY THE COMPANY OR ANYONE ELSE. BOCK ACKNOWLEDGES AND AGREES THAT HE HAS CAREFULLY READ THIS AGREEMENT AND THAT HE
HAS ASKED ANY QUESTIONS NEEDED FOR HIM TO UNDERSTAND THE TERMS, CONSEQUENCES, AND BINDING EFFECT OF THIS AGREEMENT AND HE FULLY UNDERSTANDS
IT, INCLUDING THAT HE IS WAIVING HIS RIGHT TO A JURY TRIAL. FINALLY, BOCK AGREES THAT HE HAS BEEN PROVIDED AN OPPORTUNITY TO SEEK
THE ADVICE OF AN ATTORNEY OF HIS CHOICE BEFORE SIGNING THIS AGREEMENT.
[SIGNATURE
PAGE FOLLOWS]
IN
WITNESS WHEREOF, the undersigned have executed this Arbitration Agreement as of the date first written above.
NOTABLE LABS, INC. |
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THOMAS
BOCK |
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By: |
/s/
Thomas I.H. Dubin |
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/s/
Thomas Bock |
Name:
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Thomas
Dubin |
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Title:
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Authorized
Signatory |
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Exhibit
31.1
CERTIFICATION
I,
Thomas A. Bock, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Notable Labs, Ltd.; |
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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(s) 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(s) 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 operation 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. |
Date:
August 14, 2024 |
|
|
|
/s/
Thomas A. Bock |
|
Thomas
A. Bock |
|
Chief
Executive Officer |
|
Exhibit
31.2
CERTIFICATION
I,
Scott A. McPherson, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Notable Labs, Ltd.; |
|
|
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(s) 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(s) 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 operation 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. |
Date:
August 14, 2024 |
|
|
|
/s/
Scott A. McPherson |
|
Scott
A. McPherson |
|
Chief
Financial Officer |
|
Exhibit
32.1
CERTIFICATION
OF CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER PURSUANT
TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-
OXLEY
ACT OF 2002
In
connection with the Quarterly Report on Form 10-Q of Notable Labs, Ltd. (the “Company”) for the quarterly period ended June
30, 2024 as filed with the Securities and Exchange Commission (the “Report”) on the date hereof, each of the undersigned
officers hereby certifies in such capacity, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002, that, to the best of such officer’s knowledge:
|
(1) |
the
Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
|
|
(2) |
the
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
Date:
August 14, 2024
/s/
Thomas A. Bock |
|
/s/
Scott A. McPherson |
Thomas
A. Bock |
|
Scott
A. McPherson |
Chief
Executive Officer |
|
Chief
Financial Officer |
v3.24.2.u1
Cover - ₪ / shares
|
6 Months Ended |
|
Jun. 30, 2024 |
Aug. 14, 2024 |
Cover [Abstract] |
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|
|
Document Fiscal Period Focus |
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|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-36581
|
|
Entity Registrant Name |
Notable
Labs, Ltd.
|
|
Entity Central Index Key |
0001603207
|
|
Entity Tax Identification Number |
00-0000000
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|
Entity Incorporation, State or Country Code |
L3
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320
Hatch Drive
|
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Foster
City
|
|
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CA
|
|
Entity Address, Postal Zip Code |
94404
|
|
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|
|
Local Phone Number |
851-2410
|
|
Title of 12(b) Security |
Ordinary
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|
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NTBL
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NASDAQ
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v3.24.2.u1
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 4,092
|
$ 11,825
|
Prepaid expenses and other current assets |
2,892
|
3,645
|
Total current assets |
6,984
|
15,470
|
Property and equipment, net |
346
|
316
|
Finance lease right-of-use assets, net |
297
|
337
|
Operating lease right-of-use assets |
1,467
|
1,694
|
Investment in SAFE |
|
1,500
|
Investment in Series Seed Preferred Stock |
1,500
|
|
Deferred financing costs |
306
|
|
Other assets |
104
|
224
|
Total assets |
11,004
|
19,541
|
Current liabilities: |
|
|
Accounts payable |
1,140
|
1,755
|
Accrued expenses and other current liabilities |
809
|
418
|
Accounts payable and accrued expenses - related party |
22
|
42
|
Finance lease liabilities, current |
79
|
78
|
Operating lease liabilities, current |
467
|
445
|
Total current liabilities |
2,517
|
2,738
|
Finance lease liabilities, net of current amount |
224
|
263
|
Operating lease liabilities, net of current amount |
1,025
|
1,263
|
Warrant liability |
52
|
163
|
Total liabilities |
3,818
|
4,427
|
Commitments and contingencies |
|
|
Shareholders’ equity |
|
|
Ordinary shares, NIS 0.35 par value, 34,285,714 shares authorized as of June 30, 2024 and December 31, 2023 and 9,659,496 issued and outstanding as of June 30, 2024 and 9,018,261 issued and outstanding as of December 31, 2023 |
849
|
788
|
Additional paid-in capital |
97,514
|
96,524
|
Accumulated deficit |
(91,293)
|
(82,308)
|
Accumulated other comprehensive income |
116
|
110
|
Total shareholders’ equity |
7,186
|
15,114
|
Total liabilities and shareholders’ equity |
$ 11,004
|
$ 19,541
|
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v3.24.2.u1
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|
Jun. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
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₪ 0.35
|
₪ 0.35
|
Common stock, shares authorized |
34,285,714
|
34,285,714
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9,659,496
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9,018,261
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9,659,496
|
9,018,261
|
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v3.24.2.u1
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Services revenue |
$ 2
|
|
$ 3
|
|
Cost of services |
|
|
|
|
Gross profit |
2
|
|
3
|
|
Operating expenses |
|
|
|
|
Research and development |
2,354
|
1,054
|
3,904
|
2,650
|
General and administrative |
3,028
|
1,932
|
5,317
|
5,855
|
Total operating expenses |
5,382
|
2,986
|
9,221
|
8,505
|
Loss from operations |
(5,380)
|
(2,986)
|
(9,218)
|
(8,505)
|
Other income (expense), net |
|
|
|
|
Change in fair value of SAFEs |
|
(858)
|
|
(2,723)
|
Change in fair value of warrant liability |
100
|
408
|
111
|
1,504
|
Other income |
61
|
1
|
122
|
17
|
Total Other income (expense) |
161
|
(449)
|
233
|
(1,202)
|
Net loss |
(5,219)
|
(3,435)
|
(8,985)
|
(9,707)
|
Other comprehensive income (expense) |
|
|
|
|
Change in foreign currency translation adjustment |
(59)
|
|
6
|
|
Comprehensive loss |
$ (5,278)
|
$ (3,435)
|
$ (8,979)
|
$ (9,707)
|
Net loss per share, basic |
$ (0.55)
|
$ (3.54)
|
$ (0.97)
|
$ (10.00)
|
Net loss per share, diluted |
$ (0.55)
|
$ (3.54)
|
$ (0.97)
|
$ (10.00)
|
Weighted-average common shares outstanding, basic |
9,455,751
|
970,402
|
9,235,006
|
970,297
|
Weighted-average common shares outstanding, diluted |
9,455,751
|
970,402
|
9,235,006
|
970,297
|
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v3.24.2.u1
Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Shareholders' Equity (Deficit) (Unaudited) - USD ($) $ in Thousands |
Preferred Stock [Member]
Redeemable Convertible Preferred Stock [Member]
|
Ordinary Shares [Member] |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
AOCI Attributable to Parent [Member] |
Total |
Balance at Dec. 31, 2022 |
|
|
$ 15
|
$ 34,061
|
$ (71,044)
|
|
$ (36,968)
|
Balance, shares at Dec. 31, 2022 |
|
|
970,192
|
|
|
|
|
Temporary equity, balance, shares at Dec. 31, 2022 |
464,321
|
|
|
|
|
|
|
Temporary equity, balance at Dec. 31, 2022 |
$ 35,352
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
|
116
|
|
|
116
|
Net loss |
|
|
|
|
(6,272)
|
|
(6,272)
|
Balance at Mar. 31, 2023 |
|
|
$ 15
|
34,177
|
(77,316)
|
|
(43,124)
|
Balance, shares at Mar. 31, 2023 |
|
|
970,192
|
|
|
|
|
Temporary equity, balance, shares at Mar. 31, 2023 |
464,321
|
|
|
|
|
|
|
Temporary equity, balance at Mar. 31, 2023 |
$ 35,352
|
|
|
|
|
|
|
Balance at Dec. 31, 2022 |
|
|
$ 15
|
34,061
|
(71,044)
|
|
(36,968)
|
Balance, shares at Dec. 31, 2022 |
|
|
970,192
|
|
|
|
|
Temporary equity, balance, shares at Dec. 31, 2022 |
464,321
|
|
|
|
|
|
|
Temporary equity, balance at Dec. 31, 2022 |
$ 35,352
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
$ (9,707)
|
Exercise of ordinary share options, shares |
|
|
|
|
|
|
5,000
|
Balance at Jun. 30, 2023 |
|
|
$ 15
|
34,384
|
(80,751)
|
|
$ (46,352)
|
Balance, shares at Jun. 30, 2023 |
|
|
970,507
|
|
|
|
|
Temporary equity, balance, shares at Jun. 30, 2023 |
464,321
|
|
|
|
|
|
|
Temporary equity, balance at Jun. 30, 2023 |
$ 35,352
|
|
|
|
|
|
|
Balance at Mar. 31, 2023 |
|
|
$ 15
|
34,177
|
(77,316)
|
|
(43,124)
|
Balance, shares at Mar. 31, 2023 |
|
|
970,192
|
|
|
|
|
Temporary equity, balance, shares at Mar. 31, 2023 |
464,321
|
|
|
|
|
|
|
Temporary equity, balance at Mar. 31, 2023 |
$ 35,352
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
|
202
|
|
|
202
|
Net loss |
|
|
|
|
(3,435)
|
|
(3,435)
|
Exercise of ordinary share options |
|
|
|
5
|
|
|
$ 5
|
Exercise of ordinary share options, shares |
|
|
315
|
|
|
|
5,000
|
Balance at Jun. 30, 2023 |
|
|
$ 15
|
34,384
|
(80,751)
|
|
$ (46,352)
|
Balance, shares at Jun. 30, 2023 |
|
|
970,507
|
|
|
|
|
Temporary equity, balance, shares at Jun. 30, 2023 |
464,321
|
|
|
|
|
|
|
Temporary equity, balance at Jun. 30, 2023 |
$ 35,352
|
|
|
|
|
|
|
Balance at Dec. 31, 2023 |
|
$ 788
|
|
96,524
|
(82,308)
|
110
|
15,114
|
Balance, shares at Dec. 31, 2023 |
|
9,018,261
|
|
|
|
|
|
Share-based compensation expense |
|
|
|
132
|
|
|
132
|
Net loss |
|
|
|
|
(3,766)
|
65
|
(3,701)
|
Balance at Mar. 31, 2024 |
|
$ 788
|
|
96,656
|
(86,074)
|
175
|
11,545
|
Balance, shares at Mar. 31, 2024 |
|
9,018,261
|
|
|
|
|
|
Balance at Dec. 31, 2023 |
|
$ 788
|
|
96,524
|
(82,308)
|
110
|
15,114
|
Balance, shares at Dec. 31, 2023 |
|
9,018,261
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
$ (8,979)
|
Exercise of ordinary share options, shares |
|
|
|
|
|
|
0
|
Balance at Jun. 30, 2024 |
|
$ 849
|
|
97,514
|
(91,293)
|
116
|
$ 7,186
|
Balance, shares at Jun. 30, 2024 |
|
9,659,496
|
|
|
|
|
|
Balance at Mar. 31, 2024 |
|
$ 788
|
|
96,656
|
(86,074)
|
175
|
11,545
|
Balance, shares at Mar. 31, 2024 |
|
9,018,261
|
|
|
|
|
|
Share-based compensation expense |
|
|
|
156
|
|
|
156
|
Net loss |
|
|
|
|
(5,219)
|
(59)
|
(5,278)
|
Issuance of restricted share awards |
|
62
|
|
719
|
|
|
781
|
Issuance of restricted share awards, shares |
|
|
656,235
|
|
|
|
|
Cancellation of restricted share awards |
|
(1)
|
|
(17)
|
|
|
$ (18)
|
Cancellation of restricted share awards, shares |
|
|
(15,000)
|
|
|
|
|
Exercise of ordinary share options, shares |
|
|
|
|
|
|
0
|
Balance at Jun. 30, 2024 |
|
$ 849
|
|
$ 97,514
|
$ (91,293)
|
$ 116
|
$ 7,186
|
Balance, shares at Jun. 30, 2024 |
|
9,659,496
|
|
|
|
|
|
X |
- DefinitionAmount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.
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v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
Net loss |
$ (8,985)
|
$ (9,707)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation |
127
|
130
|
Share-based compensation |
1,051
|
318
|
Non-cash operating leases |
227
|
371
|
Change in fair value of SAFEs |
|
2,723
|
Change in fair value of warrant liability |
(111)
|
(1,504)
|
Change in operating assets and liabilities |
|
|
Prepaid expenses |
855
|
619
|
Other assets |
18
|
|
Accounts payable |
(607)
|
1,365
|
Accrued expenses and other current liabilities |
390
|
227
|
Accounts payable - related parties |
(20)
|
|
Operating lease liabilities |
(216)
|
(375)
|
Net cash used in operating activities |
(7,271)
|
(5,833)
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
Purchases of property and equipment |
(14)
|
(30)
|
Trademark costs |
(1)
|
|
Net cash used in investing activities |
(15)
|
(30)
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
Proceeds from employee options |
|
5
|
Repayment of finance lease liabilities |
(38)
|
(25)
|
Deferred financing costs |
(306)
|
|
Proceeds from issuance of the SAFE agreements |
|
6,198
|
Net cash (used in) provided by financing activities |
(344)
|
6,178
|
Net increase (decrease) in cash and cash equivalents |
(7,630)
|
315
|
Effect of exchange rate changes on cash |
(103)
|
|
Cash and cash equivalents at the beginning of the period |
11,825
|
1,581
|
Cash and cash equivalents at the end of the period |
4,092
|
1,896
|
SUPPLEMENTAL DISCLOSURE OF NON-CASH FINANCING ACTIVITIES: |
|
|
Issuance of finance lease liability for finance lease right-of-use asset |
|
405
|
Issuance of operating lease liability for operating lease right-of-use asset |
|
$ 1,950
|
X |
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v3.24.2.u1
ORGANIZATION AND DESCRIPTION OF BUSINESS
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
ORGANIZATION AND DESCRIPTION OF BUSINESS |
NOTE
1 – ORGANIZATION AND DESCRIPTION OF BUSINESS
Notable
Labs, Ltd., previously known as Vascular Biogenics, Ltd., is an Israeli corporation (“Notable”). These consolidated financial
statements include three wholly owned subsidiaries, Notable Labs, Inc. (“Notable US”), VBL, Inc. (“VBL”) and
Notable Therapeutics, Inc. (“Therapeutics”) (together with Notable, the “Company”). All material intercompany
transactions have been eliminated in consolidation.
Notable
US was incorporated as a Delaware corporation in 2014. Initially, Notable US developed its Predictive Medicines Platform (“PMP”)
as a diagnostic tool for physicians for identifying which cancer treatment would be the most effective for an individual patient. Notable
US then broadened its mission and applied its PMP to streamline and accelerate the identification and validation of investigational compounds,
working with multiple biotechnology and pharmaceutical companies under service-based agreements. In 2021, by entering into the Oncoheroes
Agreement and the CicloMed Agreement, Notable US advanced from a purely diagnostic company to an integrated – diagnostic and therapeutic
– platform therapeutics company designing and developing or co-developing predictive medicines.
On
October 16, 2023, pursuant to the Agreement and Plan of Merger, dated February 22, 2023 (the “Merger Agreement”), by and
among Notable Labs, Ltd., Merger Sub, and Notable US, Merger Sub was merged with and into Notable US, with Notable US continuing after
the merger as the surviving entity and a wholly owned subsidiary of Notable Labs, Ltd. (the “Merger”). At the effective time
of the Merger, without any action on the part of any stockholder, each issued and outstanding share of pre-Merger Notable US common stock,
par value $0.001 per share (the “Notable US Common Stock”), including shares underlying pre-Merger Notable US outstanding
equity awards, was converted into the right to receive 0.0629 shares (the “Exchange Ratio”) of Notable Labs, Ltd. ordinary
shares, NIS 0.35 par value per share (the “Company Ordinary Shares” or “Notable Ordinary Shares”). Immediately
following the effective time of the Merger, Notable effected a 1-for-35 reverse stock split of the issued and outstanding Notable Ordinary
Shares (the “Reverse Share Split”).
In
connection with the closing of the Merger, Notable changed its name to Notable Labs, Ltd. and Notable’s Ordinary Shares listed
on The Nasdaq Capital Market, previously trading through the close of business on October 16, 2023 under the trading symbol “VBLT”,
commenced trading on The Nasdaq Capital Market, on a post-Reverse Share Split adjusted basis, under the trading symbol “NTBL”
on October 17, 2023.
Liquidity
and Going Concern Assessment
The
Company has incurred losses and negative cash flows from operations since its inception. As of June 30, 2024 and December 31, 2023, the
Company had an accumulated deficit of approximately $91.3
million and $82.3
million, respectively. As of June 30, 2024, the
Company had cash of $4.1
million and has forecasted cash needs in excess of current
liquidity. These conditions raise substantial doubt about its ability to continue as a going concern within one year after the date that
the consolidated financial statements are issued.
The
Company’s ability to fund its operations will require additional capital, and the Company intends to raise such capital through
the issuance of additional debt or equity, including through licensing or collaboration agreements.
These
plans are intended to mitigate the relevant conditions or events that raise substantial doubt about the Company’s ability to continue
as a going concern; however, as the plans are not entirely within the Company’s control, management has determined it is not probable
they will be effectively implemented.
These
financial statements have been prepared on a going concern basis and do not include any adjustments to the amounts and classification
of assets and liabilities that may be necessary in the event the Company can no longer continue as a going concern.
The
Company is continuing to develop its predictive medicine platform and treatments, which is the primary use of funds for the Company.
Management expects to continue to incur additional substantial losses and negative cash flows from operations in the foreseeable future
as a result of expanded research and development activities until regulatory approval is granted. Regulatory approval is not guaranteed
and may never be obtained.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish these plans and secure
sources of financing and ultimately attain profitable operations. However, if such financing is not approved, does not occur, or alternative
financing is not available at adequate levels or on acceptable terms, or profitable operations are not attained, the Company could be
required to significantly reduce operating expenses and delay, reduce the scope of or eliminate some of its development programs, enter
into a collaboration or other similar arrangement with respect to commercialization rights to any of its product candidates, out license
intellectual property rights to its product candidates and sell unsecured assets, or a combination of the above. Any of these actions
could have a material adverse effect on the Company’s business, results of operations, financial condition and/or its ability to
fund its scheduled obligations on a timely basis or at all. If the Company is unable to obtain adequate capital, it could be forced to
cease operations.
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BASIS OF PREPARATION OF THE FINANCIAL STATEMENTS
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
BASIS OF PREPARATION OF THE FINANCIAL STATEMENTS |
NOTE
2 – BASIS OF PREPARATION OF THE FINANCIAL STATEMENTS
The
accompanying unaudited condensed consolidated financial statements of Notable have been prepared in accordance with accounting principles
generally accepted in the United States (“GAAP”) for interim financial information. Accordingly, they do not include all
of the information and notes required by GAAP for annual financial statements. These unaudited interim condensed consolidated financial
statements should therefore be read in conjunction with the audited consolidated financial statements and notes included in Form 10-K,
filed with the Securities and Exchange Commission on April 11, 2024. In the opinion of management, all adjustments (of a normal recurring
nature) considered necessary for the fair statement of the results for the interim periods presented have been included. Operating results
for the interim period are not necessarily indicative of the results that may be expected for the full year.
Notable
affected a 1-for-35 reverse stock split immediately following the effective time of the Merger. No fractional shares were issued in connection
with the Reverse Share Split. Each shareholder who did not have a number of shares evenly divisible pursuant to the Reverse Share Split
ratio and who would otherwise be entitled to receive a fractional ordinary share was entitled to receive an additional Notable Ordinary
Share. The number of shares on equity related disclosures included in the condensed consolidated financial statements and accompanying
notes, were retroactively adjusted to reflect the effects of the Reverse Share Split and the Exchange Ratio.
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v3.24.2.u1
SIGNIFICANT ACCOUNTING POLICIES
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
SIGNIFICANT ACCOUNTING POLICIES |
NOTE
3 – SIGNIFICANT ACCOUNTING POLICIES
The
accounting policies and calculation methods applied in the preparation of the unaudited condensed consolidated interim financial statements
as of June 30, 2024 are consistent with those applied in the preparation of the annual financial statements as of December 31, 2023 and
for the year then ended.
Revenue
Recognition
The
Company performed certain diagnostics services on a limited basis as an outsourced provider during the three and six months ended June
30, 2024 and 2023, but such activities do not represent its major and ongoing central operations.
The
Company recognizes revenue from diagnostic services in the amount that reflects the consideration that it expects to be entitled as the
Company performs its obligation under a contract with a customer by processing diagnostic tests on laboratory samples and making the
test results available to its customers. Revenue is recorded considering a five-step revenue recognition model that includes identifying
the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating
the transaction price to the performance obligations, and recognizing revenue when, or as, an entity satisfies a performance obligation.
The Company generally has a contract or a purchase order from a customer with the specified required terms, including the number of diagnostic
samples to be performed. The Company has not received any advance payments for which there are any remaining performance obligations.
Accordingly, no deferred revenue is recorded as of June 30, 2024 or December 31, 2023. The Company has not recorded any contract assets
as of June 30, 2024 and December 31, 2023 as the Company has not completed any performance obligations for which it has not been able
to bill its customers.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
An
allowance for expected credit losses is established, as necessary, based on past experience and other factors which, in management’s
judgment, deserve current recognition in estimating bad debts. Such factors include growth and composition of accounts receivable, the
relationship of the allowance for expected credit losses to accounts receivable, and current economic conditions. The determination of
the collectability of amounts due requires the Company to make judgments regarding future events and trends. Allowances for expected
credit losses are determined based on assessing the Company’s portfolio on an individual customer and on an overall basis. This
process consists of a review of historical collection experience, current aging status of the customer account, and the financial condition
of the Company’s customers. Based on a review of these factors, the Company establishes or adjusts the allowance for specific customers
and the accounts receivable portfolio as a whole. At June 30, 2024 and December 31, 2023, an allowance for expected credit losses was
not considered necessary as all accounts receivable were deemed collectible.
Cost
of Services
Cost
of services represents costs directly related to the services performed. Cost of services is primarily comprised of cost of samples and
labor.
Use
of Estimates
The
preparation of the condensed consolidated financial statements in conformity with GAAP generally requires management to make certain
estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and accompanying notes.
The Company regularly evaluates estimates and assumptions related to assets and liabilities, and disclosures of contingent assets and
liabilities at the dates of the condensed consolidated financial statements and the reported amounts of expenses during the reporting
period. Areas where management uses subjective judgments include, but are not limited to, measurement of lease liabilities and right-of-use
assets, impairment of long-lived assets, stock-based compensation, accrued research and development costs, SAFEs and warrant liability
in the accompanying condensed consolidated financial statements. Management bases its estimates on historical experience and on various
other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments
about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially
from these estimates under different assumptions or conditions.
Segments
The
Company operates and manages its business as one reportable operating segment, which is the business of developing predictive medicines
that treat various forms of cancer. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial
information on an aggregate basis for allocating resources and evaluating financial performance. All of the Company’s long-lived
assets are maintained in, and all revenues and losses are attributable to, the United States of America.
Recently
Adopted Accounting Pronouncements
As
of June 30, 2024, there are no recently adopted accounting standards which the Company expects would have a material effect on the Company’s
condensed consolidated financial statements.
Recently
Issued Accounting Pronouncements Not Yet Adopted
As
of June 30, 2024, there are no recently issued accounting standards not yet adopted which the Company expects would have a material effect
on the Company’s condensed consolidated financial statements.
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v3.24.2.u1
FAIR VALUE MEASUREMENTS
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
FAIR VALUE MEASUREMENTS |
NOTE
4 – FAIR VALUE MEASUREMENTS
The
following table sets forth the Company’s financial liabilities that are measured at fair value on a recurring basis by level within
the fair value hierarchy (in thousands):
SCHEDULE
OF FAIR VALUE OF FINANCIAL LIABILITIES ON RECURRING BASIS
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total Fair
Value | |
| |
As of June 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total Fair Value | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | — | | |
$ | — | | |
$ | 52 | | |
$ | 52 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total Fair
Value | |
| |
As of December 31, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total Fair Value | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | — | | |
$ | — | | |
$ | 163 | | |
$ | 163 | |
There
were no transfers between Levels 1, 2, or 3 during the six months ended June 30, 2024 and the year ended December 31, 2023. Additionally,
there were no cash equivalents or marketable securities held as of June 30, 2024 and December 31, 2023.
The
value of the warrants was based on the estimated value of the warrant using the Black-Scholes-Merton model as of June 30, 2024. The following
assumptions were used in determining the fair value of the warrants:
SCHEDULE
OF FAIR VALUE ASSUMPTIONS OF WARRANT
| |
| | |
Risk Free interest rate | |
| 4.3 | % |
Expected life (years) | |
| 7.96 | |
Expected volatility | |
| 168.1 | % |
Annual dividend yield | |
| 0 | % |
Warrants measurement input | |
| 0 | % |
The
following is a summary of the Company’s warrant liability activity for the six months ended June 30, 2024 and 2023 (in thousands):
SCHEDULE
OF WARRANT LIABILITY ACTIVITY
| |
June 30, 2024 | |
Balance as of December 31, 2023 | |
$ | 163 | |
Change in fair value | |
| (111 | ) |
Balance as of June 30, 2024 | |
$ | 52 | |
| |
June 30, 2023 | |
Balance as of December 31, 2022 | |
$ | 5,113 | |
Beginning balance | |
$ | 5,113 | |
Change in fair value | |
| (1,504 | ) |
Balance as of June 30, 2023 | |
$ | 3,609 | |
Ending balance | |
$ | 3,609 | |
The
change in the fair value of the warrant liability resulted from a reduction in the value per warrant based on the fair market valuation
of the warrants as of June 30, 2024. The reduction for the six months ended June 30, 2024 related to the decrease in the price of the
underlying shares and the reduction for the six months ended June 30, 2023 related to the decrease in the value of the underlying shares.
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v3.24.2.u1
BALANCE SHEET COMPONENTS
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
BALANCE SHEET COMPONENTS |
NOTE
5 – BALANCE SHEET COMPONENTS
Prepaid
Expenses and Other Current Assets
The
following table presents the components of prepaid expenses and other current assets as of June 30, 2024 and December 31, 2023 (in thousands):
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
June 30, 2024 | | |
December 31, 2023 | |
Accounts receivable | |
$ | 184 | | |
$ | 186 | |
Employee retention credit | |
| 316 | | |
| 572 | |
Prepaid expenses | |
| 2,352 | | |
| 2,857 | |
Prepaid benefits | |
| 34 | | |
| 24 | |
Prepaid clinical expenses | |
| 6 | | |
| 6 | |
Total prepaid expenses and other current assets | |
$ | 2,892 | | |
$ | 3,645 | |
During
fiscal years 2020 and 2021, the Company took advantage of the relief provisions provided by the U.S. government in response to COVID-19
under the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”). The CARES Act provides an employee retention credit
(“Employee Retention Credit”), which is a refundable tax credit against certain employment taxes dependent on certain qualified
wages paid to employees through fiscal year 2021. The Company qualifies for the tax credit under the CARES Act and continued to receive
additional tax credits under the additional relief provisions for qualified wages through the end of 2021. The Company accounts for these
labor related tax credits as a reduction to the expense that they are intended to compensate in the period in which the corresponding
expense is incurred and there is reasonable assurance the Company will both receive the tax credits and comply with all conditions attached
to the tax credits. As of June 30, 2024 and December 31, 2023, $0.3 million and $0.6 million was recorded as a receivable in prepaid
expenses and other current assets. The Company received $0.3 million during the six months ended June 30, 2024 and recorded a bad debt
for $0.01 million, received $0.7 million of the receivable during the six months ended June 30, 2023 and believes there is reasonable
assurance the remaining balance will be collected.
Property
and Equipment, Net
The
following table presents the components of property and equipment, net, as of June 30, 2024 and December 31, 2023 (in thousands):
SCHEDULE OF PROPERTY AND EQUIPMENT
| |
June 30, 2024 | | |
December 31, 2023 | |
Computer equipment | |
$ | 202 | | |
$ | 192 | |
Laboratory equipment | |
| 2,102 | | |
| 1,999 | |
Furniture and office equipment | |
| 29 | | |
| 29 | |
Leasehold improvements | |
| 76 | | |
| 73 | |
Total property and equipment,
gross | |
| 2,409 | | |
| 2,293 | |
Less: accumulated depreciation | |
| (2,063 | ) | |
| (1,977 | ) |
Total property and equipment, net | |
$ | 346 | | |
$ | 316 | |
Depreciation
expense was approximately $0.0 million and $0.1 million for both the three and six months ended June 30, 2024 and 2023, respectively.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Investment
in SAFE and Series Seed Preferred Stock
In
October 2021, the Company entered into a simple agreement for future equity (“Oncoheroes SAFE”) agreement for $1.5
million in exchange for a right to participate in a future equity financing of preferred stock to be issued by Oncoheroes
Biosciences Inc. (“Oncoheroes”). Alternatively, upon a dissolution or liquidity event such as a change in control or an
initial public offering, the Company would be entitled to receive a portion of $1.5
million. The number of shares of preferred stock would be determined by dividing the Oncoheroes SAFE purchase amount by the price
per share of the preferred stock issued in the respective equity financing. The Company recorded the investment of $1.5
million as an investment in the Oncoheroes SAFE on the condensed consolidated balance sheet as of December 31, 2023. The investment
in the Oncoheroes SAFE was treated as an investment in an equity security that the Company elected to record at its cost less any
impairment as of December 31, 2023.
Effective
April 15, 2024, the Oncoheroes SAFE converted into Series Seed Preferred Stock of Oncoheroes (“Series Seed Preferred
Stock”) with an aggregate liquidation preference of $1.5
million. The Company recorded the investment of $1.5 million
as an investment in Series Seed Preferred Stock on the condensed consolidated balance sheet(unaudited) as of June 30, 2024. The
investment in the Oncoheroes Series Seed Preferred Stock is treated as an investment in an equity security that the Company has
elected to record at its cost less any impairment as of June 30, 2024.
No
impairment losses have been recognized related to the investment for the three and six months ended June 30, 2024 and 2023 (See Note
8).
Accrued
Expenses and Other Current Liabilities
The
following table presents the components of accrued expenses and other current liabilities as of June 30, 2024 and December 31, 2023 (in
thousands):
SCHEDULE
OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
| |
June 30, 2024 | | |
December 31, 2023 | |
Accrued expenses | |
$ | 370 | | |
| 107 | |
Accrued employee expenses | |
| 8 | | |
| 78 | |
Accrued bonuses | |
| 431 | | |
| 233 | |
Total accrued expenses and other current liabilities | |
$ | 809 | | |
$ | 418 | |
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v3.24.2.u1
TRADEMARKS
|
6 Months Ended |
Jun. 30, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
TRADEMARKS |
NOTE
6 – TRADEMARKS
Costs
associated with the registration of trademarks have been capitalized in the amount of $1,300
and have been included in other assets. As of June 30, 2024 and December 31, 2023, no trademark has been filed, however, when the trademark is filed, the
costs will be amortized over the estimated useful life of 20
years.
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v3.24.2.u1
ACCOUNTS PAYABLE - RELATED PARTIES
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
ACCOUNTS PAYABLE - RELATED PARTIES |
NOTE
7 – ACCOUNTS PAYABLE - RELATED PARTIES
As
of June 30, 2024 and December 31, 2023, the Company owed related parties the following (in thousands):
SCHEDULE
OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES RELATED PARTIES
| |
June 30, 2024 | | |
December 31, 2023 | |
Board Member | |
$ | 22 | | |
$ | 42 | |
For
consulting services with the Board Member, the Company recorded general and administrative expenses of $65,691 and $128,250 for the three
and six months ended June 30, 2024 and $61,623 and $105,401 for the three and six months ended June 30, 2023.
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.24.2.u1
CO-DEVELOPMENT AND LICENSE AGREEMENTS
|
6 Months Ended |
Jun. 30, 2024 |
Research and Development [Abstract] |
|
CO-DEVELOPMENT AND LICENSE AGREEMENTS |
NOTE
8 – CO-DEVELOPMENT AND LICENSE AGREEMENTS
Oncoheroes
Agreement
In
September 2021, the Company entered into an Exclusive License Agreement with Oncoheroes (the “Oncoheroes Agreement”) whereby
the Company obtained worldwide exclusive development and commercialization rights in the small molecule volasertib for uses relating
to certain types of cancer in adults. Under the terms of the Oncoheroes Agreement, Oncoheroes retains the right to develop and commercialize
volasertib for cancers not licensed to the Company.
Under
the terms of the agreement, the Company is obligated to make additional clinical and regulatory milestone payments up to a total of $8.0
million, plus tiered royalties from the mid-single digits up to mid-teens on net sales. When a licensed product is submitted to NDA,
the Company is required to pay $1 million, upon US NDA approval, the Company is required to pay $4 million and upon EU MAA Approval,
the Company is required to pay $3 million. In the event the Company grants a sublicense of rights, the Company will need to pay Oncoheroes
a high single digit percentage of any upfront payment obtained from such sublicenses. No milestones have been met during the six months
ended June 30, 2024 and 2023, and the Company did not make any royalty payments as the related product has not been approved for commercialization.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
Company also entered a SAFE agreement with Oncoheroes in October 2021 for $1.5 million recorded in the investment in SAFE on the condensed
consolidated balance sheets, as discussed in Note 5.
CicloMed
Agreement
In
July 2021, the Company entered into a Co-Development and Profit-Sharing Agreement with CicloMed LLC (“CicloMed”) (the
“CicloMed Agreement”) regarding use of the Company’s precision oncology diagnostic test in the research and
development of CicloMed’s CicloProx product for the treatment of acute myeloid leukemia. Under the terms of the co-development
agreement, CicloMed holds the primary responsibility for executing clinical trial operations while the Company is primarily focused
on optimizing the Company’s predictive medicines platform. Both parties will equally share the costs associated with the
on-going clinical trial incurred after the effective date. In the event a CicloProx product is commercially developed and sold, the
parties will share in the net proceeds. The Company recorded $0.0
million and $0.1
million for the three and six months ended June 30, 2024 and $0.1
million and $0.2
million for the three and six months ended June 30, 2023, respectively, as research and development expense related to this
agreement.
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- DefinitionTabular disclosure of significant agreements under research and development arrangements accounted for as a contract to perform research and development for others (including royalty arrangements, purchase provisions, license agreements, and commitments to provide additional funding), aggregated by similar arrangements or individually if necessary to understand the effects on the financial statements. Include also the amount of costs incurred under a research and development arrangement accounted for as a contract to perform research and development for others. Aggregation of similar arrangements by type may be appropriate. Include also the amount of compensation earned (contract income) under a research and development arrangement accounted for as a contract to perform research and development for others. Aggregation of similar arrangements by type may be appropriate.
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v3.24.2.u1
INCOME TAXES
|
6 Months Ended |
Jun. 30, 2024 |
Income Tax Disclosure [Abstract] |
|
INCOME TAXES |
NOTE
9 – INCOME TAXES
As
of January 1, 2024, the Company had no unrecognized tax benefits, and accordingly, the Company did not recognize interest or penalties
during the six months ended June 30, 2024 related to unrecognized tax benefits. There has been no change in unrecognized tax benefits
during the six months ended June 30, 2024, and there was no accrual for uncertain tax positions as of June 30, 2024. Tax years from 2020
through 2023 remain subject to examination by major tax jurisdictions.
There
is no income tax benefit for the losses for the three and six months ended June 30, 2024 and 2023, since management has determined that
the realization of the net tax deferred asset is not assured and has created a valuation allowance for the entire amount of such benefits.
|
X |
- DefinitionThe entire disclosure for income tax.
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v3.24.2.u1
LEASES
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
LEASES |
NOTE
10 - LEASES
The
following table summarizes total lease expense during the three and six months ended June 30, 2024 and 2023 (in thousands):
SCHEDULE
OF LEASES EXPENSES
| |
| | | |
| | | |
| | | |
| | |
| |
For the Three Months Ended | | |
For the Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Amortization of ROU assets - finance lease | |
$ | 20 | | |
$ | 20 | | |
$ | 40 | | |
$ | 27 | |
Interest on lease liabilities - finance lease | |
$ | 2 | | |
$ | 3 | | |
$ | 5 | | |
$ | 4 | |
Cash paid for financing lease liabilities | |
$ | 17 | | |
$ | - | | |
$ | 38 | | |
$ | - | |
Cash paid for operating lease liabilities | |
$ | 84 | | |
$ | 188 | | |
$ | 216 | | |
$ | 375 | |
Operating lease expense | |
$ | 137 | | |
$ | 186 | | |
$ | 257 | | |
$ | 371 | |
Variable lease expense | |
$ | - | | |
$ | 20 | | |
$ | 4 | | |
$ | 42 | |
Short-term lease expense | |
$ | 1 | | |
$ | 1 | | |
$ | 1 | | |
$ | 1 | |
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
following table summarizes amounts due under lease liabilities and the reconciliation of lease liabilities as of June 30, 2024 (in thousands):
SCHEDULE
OF MATURITIES OF LEASE LIABILITIES AND THE RECONCILIATION OF LEASE LIABILITIES
| |
Lease Obligation | |
| |
Finance Lease | | |
Facilities Lease | |
2024 | |
$ | 44 | | |
$ | 272 | |
2025 | |
| 87 | | |
| 552 | |
2026 | |
| 87 | | |
| 569 | |
2027 | |
| 87 | | |
| 239 | |
2028 and thereafter | |
| 15 | | |
| - | |
Total future undiscounted lease payments | |
| 320 | | |
| 1,632 | |
Less: imputed interest | |
| (17 | ) | |
| (140 | ) |
Total lease liabilities | |
$ | 303 | | |
$ | 1,492 | |
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v3.24.2.u1
EQUITY INCENTIVE PLANS AND STOCK BASED COMPENSATION EXPENSE
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
EQUITY INCENTIVE PLANS AND STOCK BASED COMPENSATION EXPENSE |
NOTE
11 – EQUITY INCENTIVE PLANS AND STOCK BASED COMPENSATION EXPENSE
2014
Equity Incentive Plan
In
September 2014, Notable’s shareholders approved the adoption of the Employee Share Ownership and Option Plan (2014) (“2014
Plan”) effective as of the closing of Notable’s public offering. Under the 2014 Plan, Notable reserved up to 26,514
Ordinary Shares. The Ordinary Shares to be issued
upon exercise of the options confer the same rights as the other Ordinary Shares, immediately upon allotment. Any
option which was granted under the 2014 Plan and was not exercised within twenty years from the date when it becomes exercisable, will
expire.
2015
Equity Incentive Plan
Notable
adopted the 2015 Equity Incentive Plan (the “2015 Plan”) in August 2015, which provides for the granting of ISO, NSO, and
restricted shares to employees, directors, and consultants. The 2015 Plan authorized a total of 37,199 shares reserved for future issuance.
Under amendments to the 2015 Plan, an additional 160,253 shares in 2017, 141,094 shares in 2019, and 31,450 shares in 2022 were authorized
to be reserved for future issuance. As of June 30, 2024, there were 66,975 Ordinary Shares reserved for future issuance pursuant to the
2015 Plan.
Options
under the 2015 Plan may be granted for periods of up to 10 years and at prices no less than 100% of the estimated fair value of the underlying
shares of common stock on the date of grant as determined by the Board provided that the exercise price of an ISO granted to a 10% stockholder
shall not be less than 110% of the estimated fair value of the shares on the date of grant. The 2015 Plan requires that options be exercised
no later than 10 years after the grant. Options granted to employees generally vest ratably on a monthly basis over four years, subject
to cliff vesting restrictions and continuing service.
2024
Employee Share Ownership and Option Plan
Notable
adopted the 2024 Employee Share Ownership and Option Plan (the “2024 Plan”) in March 2024, which provides for the
granting of ISO, NSO, restricted shares and restricted units to employees, directors, and consultants. The 2024 Plan authorized a
total of 4
million shares reserved for future issuance. The shares may be increased automatically (i)
on an annual basis on January 1 of each year (unless resolved otherwise by the Board of Directors), such that the number of shares
issuable under the Plan shall equal 35% of the Company’s issued and outstanding share capital on a fully diluted basis; and
(ii) in the event that any Ordinary Shares would have otherwise returned to the Company’s 2014 Plan, such Ordinary Shares
shall be added to the 2024 Plan. As of June 30, 2024, there were 4
million Ordinary Shares reserved for future issuance pursuant to the 2024 Plan.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Options
under the 2024 Plan may be granted for periods of up to 10 years and at prices no less than 100% of the estimated fair value of the underlying
shares of common stock on the date of grant as determined by the Board provided that the exercise price of an ISO granted to a 10% stockholder
shall not be less than 110% of the estimated fair value of the shares on the date of grant. The 2024 Plan requires that options be exercised
no later than 10 years after the grant. Options granted to employees generally vest ratably on a monthly basis over four years, subject
to cliff vesting restrictions and continuing service.
Share
Option Awards
The
following summarizes stock option activity under all of the Plans:
SCHEDULE
OF STOCK OPTIONS
| |
Options Outstanding | |
| |
Total Options
Outstanding | | |
Weighted-Average
Exercise Price | | |
Weighted-Average
Remaining
Contractual Life | | |
Aggregate
Intrinsic Value | |
| |
| | |
| | |
(in years) | | |
(in thousands) | |
Outstanding as of December 31, 2023 | |
| 284,437 | | |
$ | 49.67 | | |
| 4.0 | | |
$ | - | |
Granted | |
| 865,299 | | |
$ | 1.20 | | |
| - | | |
| - | |
Cancelled | |
| (154,368 | ) | |
$ | 67.26 | | |
| - | | |
| - | |
Outstanding as of June 30, 2024 | |
| 995,368 | | |
$ | 4.80 | | |
| 9.4 | | |
$ | - | |
Exercisable as of June 30, 2024 | |
| 136,101 | | |
$ | 25.67 | | |
| 7.4 | | |
$ | - | |
Vested and expected to vest as of June 30, 2024 | |
| 995,368 | | |
$ | 4.80 | | |
| 9.4 | | |
$ | - | |
No
options were exercised during the three and six months ended June 30, 2024 and 5,000 shares were exercised during the three and six months
ended June 30, 2023.
During
the three and six months ended June 30, 2024, the Company issued in aggregate 810,000
and 865,299
options to purchase the Company’s ordinary shares to board members, employees and consultants under the 2014 Plan and the 2024 Plan. The weighted-average grant date fair value of the options granted during
the three and six months ended June 30, 2024, was $1.19
and $1.20
per share. During the three and six months ended June 30, 2023, the Company did not issue any options. Notable estimated the fair
value of stock options using the Black-Scholes-Merton option pricing model which requires the use of highly subjective assumptions
to determine the fair value of stock-based awards. The fair value of employee and non-employee stock options is recognized as
expense on the straight-line basis over the requisite service period of the awards. These assumptions include:
|
● |
Risk-free
interest rate — The risk-free interest rate is based on the U.S. Treasury zero coupon issues in effect at the time of grant
for periods corresponding with the expected term of option. |
|
|
|
|
● |
Expected
volatility —The Company uses the volatility of the ordinary shares traded in the public market. |
|
|
|
|
● |
Expected
term — The expected term represents the period that stock-based awards are expected to be outstanding. The expected term
for option grants is determined using the simplified method. The simplified method deems the term to be the midpoint of the time-to-vesting
and the contractual term of the stock-based awards. The Company utilizes this method due to lack of historical exercise data. |
|
|
|
|
● |
Expected
dividend rate — The Company has never paid dividends on its ordinary shares and has no plans to pay dividends on its ordinary
shares. Therefore, the Company used an expected dividend yield of zero. |
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
The
fair value of stock options granted during the six months ended June 30, 2024 was estimated using the following weighted-average assumptions:
SCHEDULE
OF STOCK OPTIONS GRANTED ASSUMPTION
| |
2024 | |
Expected term (in years) | |
| 10 | |
Risk-free interest rate | |
| 4.2% - 4.5 | % |
Expected dividend rate | |
| - | % |
Expected volatility | |
| 168.%
- 170.7 | % |
The
following table summarizes the components of share-based compensation expense relating to options recognized in the Company’s condensed
consolidated statement of operations and comprehensive loss (in thousands):
SCHEDULE
OF SHARE BASED COMPENSATION
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 46 | | |
$ | 25 | | |
$ | 145 | | |
$ | 51 | |
General and administrative | |
| 109 | | |
| 177 | | |
| 143 | | |
| 267 | |
Total | |
$ | 155 | | |
$ | 202 | | |
$ | 288 | | |
$ | 318 | |
As
of June 30, 2024, the total share-based compensation expense related to stock awards not yet recognized was $1.3 million and will be
recognized over a weighted-average remaining period of approximately 2.8 years.
Restricted
Share Awards
The
following summarizes restricted stock awards (“RSA”) activity under all of the Plans:
SCHEDULE OF RESTRICTED STOCK AWARDS
| |
Total RSAs
Outstanding | |
| |
| |
Outstanding as of December 31, 2023 | |
| - | |
Granted | |
| 656,235 | |
Cancelled | |
| (15,000 | ) |
Outstanding as of June 30, 2024 | |
| 641,235 | |
Exercisable as of June 30, 2024 | |
| - | |
Vested and expected to vest as of June 30, 2024 | |
| 641,235 | |
During
the three and six months ended June 30, 2024, the Company issued RSAs to purchase 656,235 of the Company’s ordinary shares to Board
members and one consultant, with a fair market value of $780,920. None of the RSA’s have vested. Of the restricted share awards
to purchase 30,000 of the Company’s ordinary shares issued to the consultant, restricted share awards to purchase 15,000 of the
Company’s ordinary shares expired pursuant to their terms.
The
vesting terms of 226,235 RSAs are two equal annual installments beginning with the first anniversary of the RSAs, 400,000 of the RSAs are four equal annual installments beginning with the first anniversary of the RSAs and the vesting terms of
the remaining 15,000 are contingent on funding of the Company.
The
following table summarizes the components of share-based compensation expense relating to RSAs recognized in the Company’s condensed
consolidated statement of operations and comprehensive loss (in thousands):
SCHEDULE
OF SHARE BASED COMPENSATION
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
General and administrative | |
| 763 | | |
| - | | |
| 763 | | |
| - | |
Total | |
$ | 763 | | |
$ | - | | |
$ | 763 | | |
$ | - | |
As
of June 30, 2024, the total share-based compensation expense related to stock awards not yet recognized was $0.0 million.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.24.2.u1
NET LOSS PER SHARE
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
NET LOSS PER SHARE |
NOTE
12 – NET LOSS PER SHARE
The
following table sets forth the computation of the basic and diluted net loss per share (in thousands except share and per share data):
SCHEDULE
OF BASIC AND DILUTED LOSS PER SHARE
| |
| | | |
| | | |
| | | |
| | |
| |
For the Three Months
Ended June 30, | | |
For the Six Months
Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (5,219 | ) | |
$ | (3,435 | ) | |
$ | (8,985 | ) | |
$ | (9,707 | ) |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted-average ordinary shares outstanding used to compute net loss per share, basic and diluted | |
| 9,455,751 | | |
| 970,402 | | |
| 9,235,006 | | |
| 970,297 | |
Net loss per share, basic and diluted: | |
$ | (0.55 | ) | |
$ | (3.54 | ) | |
$ | (0.97 | ) | |
$ | (10.00 | ) |
The
Company’s potentially dilutive securities have been excluded from the computation of diluted net loss per share as the effect would
be antidilutive. Therefore, the weighted-average number of ordinary shares outstanding used to calculate both basic and diluted net loss
per share is the same.
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v3.24.2.u1
SUBSEQUENT EVENTS
|
6 Months Ended |
Jun. 30, 2024 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
13 – SUBSEQUENT EVENTS
On
July 17, 2024, the Company received a written notification (the “Notice”) from the Nasdaq
Stock Market LLC (“Nasdaq”), indicating that the Company was not in compliance with the minimum closing bid price requirement
set forth in Nasdaq Rules for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(a)(2) requires listed securities
to maintain a minimum bid price of $1.00 per share, and Listing Rule 5810(c)(3)(A) provides that a failure to meet the minimum bid price
requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the closing bid price of the Company’s
ordinary shares for the 30 consecutive business days from June 3, 2024, to July 16, 2024, the Company no longer meets the minimum bid
price requirement.
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v3.24.2.u1
SIGNIFICANT ACCOUNTING POLICIES (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Revenue Recognition |
Revenue
Recognition
The
Company performed certain diagnostics services on a limited basis as an outsourced provider during the three and six months ended June
30, 2024 and 2023, but such activities do not represent its major and ongoing central operations.
The
Company recognizes revenue from diagnostic services in the amount that reflects the consideration that it expects to be entitled as the
Company performs its obligation under a contract with a customer by processing diagnostic tests on laboratory samples and making the
test results available to its customers. Revenue is recorded considering a five-step revenue recognition model that includes identifying
the contract with a customer, identifying the performance obligations in the contract, determining the transaction price, allocating
the transaction price to the performance obligations, and recognizing revenue when, or as, an entity satisfies a performance obligation.
The Company generally has a contract or a purchase order from a customer with the specified required terms, including the number of diagnostic
samples to be performed. The Company has not received any advance payments for which there are any remaining performance obligations.
Accordingly, no deferred revenue is recorded as of June 30, 2024 or December 31, 2023. The Company has not recorded any contract assets
as of June 30, 2024 and December 31, 2023 as the Company has not completed any performance obligations for which it has not been able
to bill its customers.
NOTABLE
LABS, LTD.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
An
allowance for expected credit losses is established, as necessary, based on past experience and other factors which, in management’s
judgment, deserve current recognition in estimating bad debts. Such factors include growth and composition of accounts receivable, the
relationship of the allowance for expected credit losses to accounts receivable, and current economic conditions. The determination of
the collectability of amounts due requires the Company to make judgments regarding future events and trends. Allowances for expected
credit losses are determined based on assessing the Company’s portfolio on an individual customer and on an overall basis. This
process consists of a review of historical collection experience, current aging status of the customer account, and the financial condition
of the Company’s customers. Based on a review of these factors, the Company establishes or adjusts the allowance for specific customers
and the accounts receivable portfolio as a whole. At June 30, 2024 and December 31, 2023, an allowance for expected credit losses was
not considered necessary as all accounts receivable were deemed collectible.
|
Cost of Services |
Cost
of Services
Cost
of services represents costs directly related to the services performed. Cost of services is primarily comprised of cost of samples and
labor.
|
Use of Estimates |
Use
of Estimates
The
preparation of the condensed consolidated financial statements in conformity with GAAP generally requires management to make certain
estimates and assumptions that affect the reported amounts in the condensed consolidated financial statements and accompanying notes.
The Company regularly evaluates estimates and assumptions related to assets and liabilities, and disclosures of contingent assets and
liabilities at the dates of the condensed consolidated financial statements and the reported amounts of expenses during the reporting
period. Areas where management uses subjective judgments include, but are not limited to, measurement of lease liabilities and right-of-use
assets, impairment of long-lived assets, stock-based compensation, accrued research and development costs, SAFEs and warrant liability
in the accompanying condensed consolidated financial statements. Management bases its estimates on historical experience and on various
other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments
about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ materially
from these estimates under different assumptions or conditions.
|
Segments |
Segments
The
Company operates and manages its business as one reportable operating segment, which is the business of developing predictive medicines
that treat various forms of cancer. The Company’s chief executive officer, who is the chief operating decision maker, reviews financial
information on an aggregate basis for allocating resources and evaluating financial performance. All of the Company’s long-lived
assets are maintained in, and all revenues and losses are attributable to, the United States of America.
|
Recently Adopted Accounting Pronouncements |
Recently
Adopted Accounting Pronouncements
As
of June 30, 2024, there are no recently adopted accounting standards which the Company expects would have a material effect on the Company’s
condensed consolidated financial statements.
|
Recently Issued Accounting Pronouncements Not Yet Adopted |
Recently
Issued Accounting Pronouncements Not Yet Adopted
As
of June 30, 2024, there are no recently issued accounting standards not yet adopted which the Company expects would have a material effect
on the Company’s condensed consolidated financial statements.
|
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v3.24.2.u1
FAIR VALUE MEASUREMENTS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
SCHEDULE OF FAIR VALUE OF FINANCIAL LIABILITIES ON RECURRING BASIS |
The
following table sets forth the Company’s financial liabilities that are measured at fair value on a recurring basis by level within
the fair value hierarchy (in thousands):
SCHEDULE
OF FAIR VALUE OF FINANCIAL LIABILITIES ON RECURRING BASIS
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total Fair
Value | |
| |
As of June 30, 2024 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total Fair Value | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | — | | |
$ | — | | |
$ | 52 | | |
$ | 52 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total Fair
Value | |
| |
As of December 31, 2023 | |
| |
Level 1 | | |
Level 2 | | |
Level 3 | | |
Total Fair Value | |
Liabilities | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | — | | |
$ | — | | |
$ | 163 | | |
$ | 163 | |
|
SCHEDULE OF FAIR VALUE ASSUMPTIONS OF WARRANT |
The
value of the warrants was based on the estimated value of the warrant using the Black-Scholes-Merton model as of June 30, 2024. The following
assumptions were used in determining the fair value of the warrants:
SCHEDULE
OF FAIR VALUE ASSUMPTIONS OF WARRANT
| |
| | |
Risk Free interest rate | |
| 4.3 | % |
Expected life (years) | |
| 7.96 | |
Expected volatility | |
| 168.1 | % |
Annual dividend yield | |
| 0 | % |
Warrants measurement input | |
| 0 | % |
|
SCHEDULE OF WARRANT LIABILITY ACTIVITY |
The
following is a summary of the Company’s warrant liability activity for the six months ended June 30, 2024 and 2023 (in thousands):
SCHEDULE
OF WARRANT LIABILITY ACTIVITY
| |
June 30, 2024 | |
Balance as of December 31, 2023 | |
$ | 163 | |
Change in fair value | |
| (111 | ) |
Balance as of June 30, 2024 | |
$ | 52 | |
| |
June 30, 2023 | |
Balance as of December 31, 2022 | |
$ | 5,113 | |
Beginning balance | |
$ | 5,113 | |
Change in fair value | |
| (1,504 | ) |
Balance as of June 30, 2023 | |
$ | 3,609 | |
Ending balance | |
$ | 3,609 | |
|
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v3.24.2.u1
BALANCE SHEET COMPONENTS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS |
The
following table presents the components of prepaid expenses and other current assets as of June 30, 2024 and December 31, 2023 (in thousands):
SCHEDULE
OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
| |
June 30, 2024 | | |
December 31, 2023 | |
Accounts receivable | |
$ | 184 | | |
$ | 186 | |
Employee retention credit | |
| 316 | | |
| 572 | |
Prepaid expenses | |
| 2,352 | | |
| 2,857 | |
Prepaid benefits | |
| 34 | | |
| 24 | |
Prepaid clinical expenses | |
| 6 | | |
| 6 | |
Total prepaid expenses and other current assets | |
$ | 2,892 | | |
$ | 3,645 | |
|
SCHEDULE OF PROPERTY AND EQUIPMENT |
The
following table presents the components of property and equipment, net, as of June 30, 2024 and December 31, 2023 (in thousands):
SCHEDULE OF PROPERTY AND EQUIPMENT
| |
June 30, 2024 | | |
December 31, 2023 | |
Computer equipment | |
$ | 202 | | |
$ | 192 | |
Laboratory equipment | |
| 2,102 | | |
| 1,999 | |
Furniture and office equipment | |
| 29 | | |
| 29 | |
Leasehold improvements | |
| 76 | | |
| 73 | |
Total property and equipment,
gross | |
| 2,409 | | |
| 2,293 | |
Less: accumulated depreciation | |
| (2,063 | ) | |
| (1,977 | ) |
Total property and equipment, net | |
$ | 346 | | |
$ | 316 | |
|
SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES |
The
following table presents the components of accrued expenses and other current liabilities as of June 30, 2024 and December 31, 2023 (in
thousands):
SCHEDULE
OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
| |
June 30, 2024 | | |
December 31, 2023 | |
Accrued expenses | |
$ | 370 | | |
| 107 | |
Accrued employee expenses | |
| 8 | | |
| 78 | |
Accrued bonuses | |
| 431 | | |
| 233 | |
Total accrued expenses and other current liabilities | |
$ | 809 | | |
$ | 418 | |
|
X |
- DefinitionTabular disclosure of the amounts paid in advance for capitalized costs that will be expensed with the passage of time or the occurrence of a triggering event, and will be charged against earnings within one year or the normal operating cycle, if longer; the aggregate carrying amount of current assets, not separately presented elsewhere in the balance sheet; and other deferred costs.
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v3.24.2.u1
LEASES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
SCHEDULE OF LEASES EXPENSES |
The
following table summarizes total lease expense during the three and six months ended June 30, 2024 and 2023 (in thousands):
SCHEDULE
OF LEASES EXPENSES
| |
| | | |
| | | |
| | | |
| | |
| |
For the Three Months Ended | | |
For the Six Months Ended | |
| |
June 30, | | |
June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Amortization of ROU assets - finance lease | |
$ | 20 | | |
$ | 20 | | |
$ | 40 | | |
$ | 27 | |
Interest on lease liabilities - finance lease | |
$ | 2 | | |
$ | 3 | | |
$ | 5 | | |
$ | 4 | |
Cash paid for financing lease liabilities | |
$ | 17 | | |
$ | - | | |
$ | 38 | | |
$ | - | |
Cash paid for operating lease liabilities | |
$ | 84 | | |
$ | 188 | | |
$ | 216 | | |
$ | 375 | |
Operating lease expense | |
$ | 137 | | |
$ | 186 | | |
$ | 257 | | |
$ | 371 | |
Variable lease expense | |
$ | - | | |
$ | 20 | | |
$ | 4 | | |
$ | 42 | |
Short-term lease expense | |
$ | 1 | | |
$ | 1 | | |
$ | 1 | | |
$ | 1 | |
|
SCHEDULE OF MATURITIES OF LEASE LIABILITIES AND THE RECONCILIATION OF LEASE LIABILITIES |
The
following table summarizes amounts due under lease liabilities and the reconciliation of lease liabilities as of June 30, 2024 (in thousands):
SCHEDULE
OF MATURITIES OF LEASE LIABILITIES AND THE RECONCILIATION OF LEASE LIABILITIES
| |
Lease Obligation | |
| |
Finance Lease | | |
Facilities Lease | |
2024 | |
$ | 44 | | |
$ | 272 | |
2025 | |
| 87 | | |
| 552 | |
2026 | |
| 87 | | |
| 569 | |
2027 | |
| 87 | | |
| 239 | |
2028 and thereafter | |
| 15 | | |
| - | |
Total future undiscounted lease payments | |
| 320 | | |
| 1,632 | |
Less: imputed interest | |
| (17 | ) | |
| (140 | ) |
Total lease liabilities | |
$ | 303 | | |
$ | 1,492 | |
|
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v3.24.2.u1
EQUITY INCENTIVE PLANS AND STOCK BASED COMPENSATION EXPENSE (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
SCHEDULE OF STOCK OPTIONS |
The
following summarizes stock option activity under all of the Plans:
SCHEDULE
OF STOCK OPTIONS
| |
Options Outstanding | |
| |
Total Options
Outstanding | | |
Weighted-Average
Exercise Price | | |
Weighted-Average
Remaining
Contractual Life | | |
Aggregate
Intrinsic Value | |
| |
| | |
| | |
(in years) | | |
(in thousands) | |
Outstanding as of December 31, 2023 | |
| 284,437 | | |
$ | 49.67 | | |
| 4.0 | | |
$ | - | |
Granted | |
| 865,299 | | |
$ | 1.20 | | |
| - | | |
| - | |
Cancelled | |
| (154,368 | ) | |
$ | 67.26 | | |
| - | | |
| - | |
Outstanding as of June 30, 2024 | |
| 995,368 | | |
$ | 4.80 | | |
| 9.4 | | |
$ | - | |
Exercisable as of June 30, 2024 | |
| 136,101 | | |
$ | 25.67 | | |
| 7.4 | | |
$ | - | |
Vested and expected to vest as of June 30, 2024 | |
| 995,368 | | |
$ | 4.80 | | |
| 9.4 | | |
$ | - | |
|
SCHEDULE OF STOCK OPTIONS GRANTED ASSUMPTION |
The
fair value of stock options granted during the six months ended June 30, 2024 was estimated using the following weighted-average assumptions:
SCHEDULE
OF STOCK OPTIONS GRANTED ASSUMPTION
| |
2024 | |
Expected term (in years) | |
| 10 | |
Risk-free interest rate | |
| 4.2% - 4.5 | % |
Expected dividend rate | |
| - | % |
Expected volatility | |
| 168.%
- 170.7 | % |
|
SCHEDULE OF SHARE BASED COMPENSATION |
The
following table summarizes the components of share-based compensation expense relating to options recognized in the Company’s condensed
consolidated statement of operations and comprehensive loss (in thousands):
SCHEDULE
OF SHARE BASED COMPENSATION
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 46 | | |
$ | 25 | | |
$ | 145 | | |
$ | 51 | |
General and administrative | |
| 109 | | |
| 177 | | |
| 143 | | |
| 267 | |
Total | |
$ | 155 | | |
$ | 202 | | |
$ | 288 | | |
$ | 318 | |
|
SCHEDULE OF RESTRICTED STOCK AWARDS |
The
following summarizes restricted stock awards (“RSA”) activity under all of the Plans:
SCHEDULE OF RESTRICTED STOCK AWARDS
| |
Total RSAs
Outstanding | |
| |
| |
Outstanding as of December 31, 2023 | |
| - | |
Granted | |
| 656,235 | |
Cancelled | |
| (15,000 | ) |
Outstanding as of June 30, 2024 | |
| 641,235 | |
Exercisable as of June 30, 2024 | |
| - | |
Vested and expected to vest as of June 30, 2024 | |
| 641,235 | |
|
Restricted Stock Awards [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
SCHEDULE OF SHARE BASED COMPENSATION |
The
following table summarizes the components of share-based compensation expense relating to RSAs recognized in the Company’s condensed
consolidated statement of operations and comprehensive loss (in thousands):
SCHEDULE
OF SHARE BASED COMPENSATION
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
General and administrative | |
| 763 | | |
| - | | |
| 763 | | |
| - | |
Total | |
$ | 763 | | |
$ | - | | |
$ | 763 | | |
$ | - | |
|
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v3.24.2.u1
NET LOSS PER SHARE (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE |
The
following table sets forth the computation of the basic and diluted net loss per share (in thousands except share and per share data):
SCHEDULE
OF BASIC AND DILUTED LOSS PER SHARE
| |
| | | |
| | | |
| | | |
| | |
| |
For the Three Months
Ended June 30, | | |
For the Six Months
Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Numerator: | |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (5,219 | ) | |
$ | (3,435 | ) | |
$ | (8,985 | ) | |
$ | (9,707 | ) |
Denominator: | |
| | | |
| | | |
| | | |
| | |
Weighted-average ordinary shares outstanding used to compute net loss per share, basic and diluted | |
| 9,455,751 | | |
| 970,402 | | |
| 9,235,006 | | |
| 970,297 | |
Net loss per share, basic and diluted: | |
$ | (0.55 | ) | |
$ | (3.54 | ) | |
$ | (0.97 | ) | |
$ | (10.00 | ) |
|
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v3.24.2.u1
ORGANIZATION AND DESCRIPTION OF BUSINESS (Details Narrative) $ / shares in Units, $ in Thousands |
|
6 Months Ended |
|
|
|
Oct. 16, 2023
$ / shares
|
Jun. 30, 2024
USD ($)
|
Jun. 30, 2024
₪ / shares
|
Dec. 31, 2023
USD ($)
|
Dec. 31, 2023
₪ / shares
|
Oct. 16, 2023
₪ / shares
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Common stock, par value | ₪ / shares |
|
|
₪ 0.35
|
|
₪ 0.35
|
|
Reverse stock split |
|
1-for-35 reverse stock split
|
|
|
|
|
Retained Earnings (Accumulated Deficit) | $ |
|
$ 91,293
|
|
$ 82,308
|
|
|
Cash and Cash Equivalents, at Carrying Value | $ |
|
$ 4,092
|
|
$ 11,825
|
|
|
Merger Agreement [Member] |
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
Common stock, par value | $ / shares |
$ 0.001
|
|
|
|
|
|
Exchange ratio of shares |
0.0629
|
|
|
|
|
0.0629
|
Preferred stock, par value | ₪ / shares |
|
|
|
|
|
₪ 0.35
|
Reverse stock split |
1-for-35 reverse stock split
|
|
|
|
|
|
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SCHEDULE OF FAIR VALUE OF FINANCIAL LIABILITIES ON RECURRING BASIS (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Warrant liability |
$ 52
|
$ 163
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Warrant liability |
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Warrant liability |
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
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$ 52
|
$ 163
|
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v3.24.2.u1
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment, gross |
$ 2,409
|
$ 2,293
|
Less: accumulated depreciation |
(2,063)
|
(1,977)
|
Total property and equipment, net |
346
|
316
|
Computer Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment, gross |
202
|
192
|
Laboratory Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment, gross |
2,102
|
1,999
|
Furniture and Office Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment, gross |
29
|
29
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment, gross |
$ 76
|
$ 73
|
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BALANCE SHEET COMPONENTS (Details Narrative) - USD ($)
|
3 Months Ended |
6 Months Ended |
|
|
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Apr. 15, 2024 |
Dec. 31, 2023 |
Oct. 31, 2021 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Employee retention credit |
$ 316,000
|
|
$ 316,000
|
|
|
$ 572,000
|
|
Proceeds from accounts receivable |
|
|
300,000
|
$ 700,000
|
|
|
|
Bad debt |
|
|
10,000.00
|
|
|
|
|
Depreciation expense |
0.0
|
$ 0.0
|
127,000
|
130,000
|
|
|
|
Investment |
|
|
|
|
|
1,500,000
|
|
Oncoheroes Safe Agreement [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Investment in SAFE |
|
|
|
|
$ 1,500,000
|
|
$ 1,500,000
|
Receivable amount |
|
|
|
|
|
|
$ 1,500,000
|
Investment |
$ 1,500,000
|
|
1,500,000
|
|
|
$ 1,500,000
|
|
Liquidation preference |
|
|
|
|
$ 1,500,000
|
|
|
Impairment losses on Investment |
|
|
$ 0
|
$ 0
|
|
|
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SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUED EXPENSES RELATED PARTIES (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Total |
$ 22
|
$ 42
|
Board Member [Member] |
|
|
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$ 22
|
$ 42
|
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|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
General and administrative expenses |
$ 3,028,000
|
$ 1,932,000
|
$ 5,317,000
|
$ 5,855,000
|
Board Member [Member] |
|
|
|
|
General and administrative expenses |
$ 65,691
|
$ 61,623
|
$ 128,250
|
$ 105,401
|
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v3.24.2.u1
CO-DEVELOPMENT AND LICENSE AGREEMENTS (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
|
Sep. 30, 2021 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Apr. 15, 2024 |
Oct. 31, 2021 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Research and development expense |
|
$ 2,354,000
|
$ 1,054,000
|
$ 3,904,000
|
$ 2,650,000
|
|
|
Oncoheroes Safe Agreement [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Milestone payments |
|
|
|
0
|
0
|
|
|
Frequency of payments |
When a licensed product is submitted to NDA,
the Company is required to pay $1 million, upon US NDA approval, the Company is required to pay $4 million and upon EU MAA Approval,
the Company is required to pay $3 million. In the event the Company grants a sublicense of rights, the Company will need to pay Oncoheroes
a high single digit percentage of any upfront payment obtained from such sublicenses.
|
|
|
|
|
|
|
Investment in SAFE |
|
|
|
|
|
$ 1,500,000
|
$ 1,500,000
|
Oncoheroes Safe Agreement [Member] | Maximum [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Milestone payments |
$ 8,000,000.0
|
|
|
|
|
|
|
CicloMed Agreement [Member] |
|
|
|
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
|
|
|
Research and development expense |
|
$ 0.0
|
$ 100,000
|
$ 100,000
|
$ 200,000
|
|
|
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Jun. 30, 2024
USD ($)
|
Leases |
|
Finance Lease Obligation, 2024 |
$ 44
|
Facilities Lease Obligation, 2024 |
272
|
Finance Lease Obligation, 2025 |
87
|
Facilities Lease Obligation, 2025 |
552
|
Finance Lease Obligation, 2026 |
87
|
Facilities Lease Obligation, 2026 |
569
|
Finance Lease Obligation, 2027 |
87
|
Facilities Lease Obligation, 2027 |
239
|
Finance Lease Obligation, 2028 and thereafter |
15
|
Facilities Lease Obligation, 2028 and thereafter |
|
Finance Lease Obligation, Total future undiscounted lease payments |
320
|
Facilities Lease Obligation, Total future undiscounted lease payments |
1,632
|
Finance Lease Obligation, imputed interest |
(17)
|
Facilities Lease Obligation, imputed interest |
(140)
|
Total Finance Lease Obligation |
303
|
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v3.24.2.u1
SCHEDULE OF STOCK OPTIONS (Details)
|
6 Months Ended |
Jun. 30, 2024
USD ($)
$ / shares
shares
|
Share-Based Payment Arrangement [Abstract] |
|
Total Options Outstanding, Outstanding beginning balance | shares |
284,437
|
Weighted Average Exercise Price, Outstanding beginning balance | $ / shares |
$ 49.67
|
Weighted Average Remaining Contractual Life (in years), Outstanding |
4 years
|
Aggregate Intrinsic Value, Outstanding | $ |
|
Total Options Outstanding, Granted | shares |
865,299
|
Weighted Average Exercise Price, Granted | $ / shares |
$ 1.20
|
Total Options Outstanding, Cancelled | shares |
(154,368)
|
Weighted Average Exercise Price, Cancelled | $ / shares |
$ 67.26
|
Total Options Outstanding, Outstanding ending balance | shares |
995,368
|
Weighted Average Exercise Price, Outstanding ending balance | $ / shares |
$ 4.80
|
Weighted Average Remaining Contractual Life (in years), Outstanding |
9 years 4 months 24 days
|
Aggregate Intrinsic Value, Outstanding | $ |
|
Total Options Outstanding, Exercisable | shares |
136,101
|
Weighted Average Exercise Price, Exercisable | $ / shares |
$ 25.67
|
Weighted Average Remaining Contractual Life (in years), Exercisable |
7 years 4 months 24 days
|
Aggregate Intrinsic Value, Exercisable | $ |
|
Total Options Outstanding, Vested and expected to vest | shares |
995,368
|
Weighted Average Exercise Price, Vested and expected to vest | $ / shares |
$ 4.80
|
Weighted Average Remaining Contractual Life (in years), Vested and expected to vest |
9 years 4 months 24 days
|
Aggregate Intrinsic Value, Vested and expected to vest | $ |
|
X |
- DefinitionWeighted average remaining contractual life (in years), outstanding.
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SCHEDULE OF SHARE BASED COMPENSATION (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
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|
|
|
Total |
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$ 202
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$ 288
|
$ 318
|
Restricted Stock Awards [Member] |
|
|
|
|
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|
|
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|
|
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|
|
|
|
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|
|
|
|
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46
|
25
|
145
|
51
|
Research and Development Expense [Member] | Restricted Stock Awards [Member] |
|
|
|
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
|
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|
|
|
|
General and Administrative Expense [Member] |
|
|
|
|
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|
|
|
|
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|
177
|
143
|
267
|
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|
|
|
|
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|
|
|
|
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$ 763
|
|
$ 763
|
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|
6 Months Ended |
Jun. 30, 2024
shares
|
Share-Based Payment Arrangement [Abstract] |
|
Total RSAs Outstanding, Outstanding Beginning Balance |
|
Total RSAs Outstanding, Outstanding Beginning Balance |
656,235
|
Total RSAs Outstanding, Cancelled |
(15,000)
|
Total RSAs Outstanding, Outstanding Ending Balance |
641,235
|
Total RSAs Outstanding, Exercisable |
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641,235
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EQUITY INCENTIVE PLANS AND STOCK BASED COMPENSATION EXPENSE (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
|
|
|
Sep. 30, 2014 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2022 |
Dec. 31, 2019 |
Dec. 31, 2017 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
Stock options exercised |
|
0
|
5,000
|
0
|
5,000
|
|
|
|
Options granted |
|
|
|
865,299
|
|
|
|
|
Options grant date fair value per share |
|
$ 1.19
|
|
$ 1.20
|
|
|
|
|
Share-based compensation expense related to stock awards not yet recognized |
|
$ 1,300,000
|
|
$ 1,300,000
|
|
|
|
|
Weighted-average remaining period |
|
|
|
2 years 9 months 18 days
|
|
|
|
|
Number of ordinary shares expired |
|
|
|
15,000
|
|
|
|
|
Restricted Stock Awards [Member] |
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
Share-based compensation expense related to stock awards not yet recognized |
|
$ 0.0
|
|
$ 0.0
|
|
|
|
|
Number of ordinary shares expired |
|
|
|
15,000
|
|
|
|
|
Vesting term |
|
|
|
15,000
|
|
|
|
|
Restricted Stock Awards [Member] | Two Equal Annual Installments [Member] |
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
Vesting term |
|
|
|
226,235
|
|
|
|
|
Resticted stock awards |
|
|
|
400,000
|
|
|
|
|
Board Members and One Consultant [Member] | Restricted Stock Awards [Member] |
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
Number of shares issued |
|
656,235
|
|
656,235
|
|
|
|
|
Fair market value |
|
|
|
$ 780,920
|
|
|
|
|
Consultant [Member] | Restricted Stock Awards [Member] |
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
30,000
|
|
|
|
|
2014 Plan [Member] |
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
Ordinary shares reserved for future issuance |
26,514
|
|
|
|
|
|
|
|
Share-based compensation arrangement by share-based payment award, description |
Any
option which was granted under the 2014 Plan and was not exercised within twenty years from the date when it becomes exercisable, will
expire.
|
|
|
|
|
|
|
|
2014 Plan [Member] | Six Board Members [Member] |
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
Options granted |
|
810,000
|
|
865,299
|
|
|
|
|
2015 Plan [Member] |
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
Ordinary shares reserved for future issuance |
|
66,975
|
|
66,975
|
|
31,450
|
141,094
|
160,253
|
Share-based compensation arrangement by share-based payment award, description |
|
|
|
Options
under the 2015 Plan may be granted for periods of up to 10 years and at prices no less than 100% of the estimated fair value of the underlying
shares of common stock on the date of grant as determined by the Board provided that the exercise price of an ISO granted to a 10% stockholder
shall not be less than 110% of the estimated fair value of the shares on the date of grant. The 2015 Plan requires that options be exercised
no later than 10 years after the grant. Options granted to employees generally vest ratably on a monthly basis over four years, subject
to cliff vesting restrictions and continuing service.
|
|
|
|
|
2024 Employee Share Ownership and Option Plan [Member] |
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
|
|
|
|
Ordinary shares reserved for future issuance |
|
4,000,000
|
|
4,000,000
|
|
|
|
|
Share-based compensation arrangement by share-based payment award, description |
|
|
|
Options
under the 2024 Plan may be granted for periods of up to 10 years and at prices no less than 100% of the estimated fair value of the underlying
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shall not be less than 110% of the estimated fair value of the shares on the date of grant. The 2024 Plan requires that options be exercised
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to cliff vesting restrictions and continuing service.
|
|
|
|
|
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|
|
|
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|
|
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|
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v3.24.2.u1
SCHEDULE OF BASIC AND DILUTED LOSS PER SHARE (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Earnings Per Share [Abstract] |
|
|
|
|
Net loss |
$ (5,219)
|
$ (3,435)
|
$ (8,985)
|
$ (9,707)
|
Weighted-average ordinary shares outstanding used to compute net loss per share, basic |
9,455,751
|
970,402
|
9,235,006
|
970,297
|
Weighted-average ordinary shares outstanding used to compute net loss per share, diluted |
9,455,751
|
970,402
|
9,235,006
|
970,297
|
Net loss per share, basic |
$ (0.55)
|
$ (3.54)
|
$ (0.97)
|
$ (10.00)
|
Net loss per share, diluted |
$ (0.55)
|
$ (3.54)
|
$ (0.97)
|
$ (10.00)
|
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Vascular Biogenics (NASDAQ:VBLT)
過去 株価チャート
から 7 2024 まで 8 2024
Vascular Biogenics (NASDAQ:VBLT)
過去 株価チャート
から 8 2023 まで 8 2024