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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): April 12, 2024
NOTABLE
LABS, LTD.
(Exact
name of registrant as specified in charter)
| Israel |
|
001-36581 |
|
Not
Applicable |
(State
or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS
Employer
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
| N/A |
| (Former
name or former address, if changed since last report) |
Securities
registered or to be 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 each |
|
NTBL |
|
The
Nasdaq Capital Market |
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
| ☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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. ☐
Item
2.02 Results of Operations and Financial Condition
On
April 12, 2024, Notable Labs, Ltd. (the “Company”) issued a press release announcing the filing of its financial results
for the year ended December 31, 2023, and providing a business update and additional financial information. A copy of the press release
is furnished herewith as Exhibit 99.1.
The
information in Item 2.02 of this Current Report on Form 8-K, including the information in the press release attached as Exhibit 99.1
to this Current Report on Form 8-K, is furnished pursuant to Item 2.02 of Form 8-K and shall not be deemed “filed” for the
purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section. Furthermore, the information in
Item 2.02 of this Current Report on Form 8-K, including the information in the press release attached as Exhibit 99.1 to this Current
Report on Form 8-K, shall not be deemed to be incorporated by reference in the filings of the Company under the Securities Act.
Item
9.01. Financial Statements and Exhibits.
(d)
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 hereunto duly authorized.
| |
NOTABLE LABS, LTD. |
| |
|
|
| Date:
April 12, 2024 |
By: |
/s/
Thomas A. Bock |
| |
Name: |
Thomas
A. Bock |
| |
Title: |
Chief
Executive Officer |
Exhibit
99.1
Notable
Labs Reports 2023 Financial Results and Provides a Business Update
FOSTER
CITY, CA, April 12, 2024 – Notable Labs, Ltd. (Nasdaq: NTBL) (“Notable”
or the “Company”), a clinical-stage precision oncology company developing new cancer therapies identified by its Predictive
Precision Medicine Platform (PPMP), reported financial results for the year ended December 31, 2023 and provided a business update.
“The
last year has been a time of great accomplishment for Notable. We built a strong clinical validation dataset, starting with a poster
presented at the American Association for Cancer Research (AACR 2023); became a publicly listed company, following the closing of a reverse
merger in October 2023; and reported successful PPMP clinical data from the Phase 2 fosciclopirox study that showcased the ability of
our platform to accurately predict patient outcomes for specific therapeutics,” said Thomas Bock, M.D., Chief Executive Officer
of Notable. “The performance of our platform in accurately predicting the outcome of the fosciclopirox study has enabled us to
enhance the clinical trial plan for our lead product candidate, volasertib, in development for patients with relapsed/refractory acute
myeloid leukemia (r/r AML). In our upcoming Phase 2 trial, we will be utilizing the platform to enrich the study’s enrollment with
patients predicted to respond to volasertib, which we believe will result in more rapid enrollment, shorter time to efficacy data and,
ultimately, increased probability of success.”
Dr.
Bock commented further, “Looking ahead, we are on track to significantly advance the clinical program for volasertib in 2024 and
further validate the potential for PPMP as a precision medicine tool. We are pleased that an abstract related to this program was presented
this week at the AACR 2024 and look forward to providing additional data in the coming months.”
Joseph
Wagner, Ph.D., Chief Scientific Officer of Notable, added, “We are enthusiastic to initiate the Phase 2 volasertib/PPMP trial in
the coming months. Our study will incorporate important learnings from prior studies conducted by volasertib’s originator, Boehringer
Ingelheim, which suggest that standardizing best supportive care and introducing body surface area-based dosing are likely to enhance
patient responses and tolerability. We plan to include and evaluate these refinements in a small
all-comers dose optimization lead-in, prior to enrolling PPMP-predicted responders. The open label design of our Phase 2 trial will enable
us to provide ongoing updates and initiate a subsequent Phase 3 trial at the earliest possibility.”
Recent
and Upcoming Milestones:
| ● |
Presentation of two posters at AACR2024: April 8 and 9, 2024 |
| |
|
| ● |
Volasertib: Advance the Phase 2 program, starting with the
dose optimization prelude |
Year
End December 31, 2023 Financial Results
Total
cash and cash equivalents (Cash) were $11.8 million as of December 31, 2023. As of April 1, 2024, Notable has cash and cash equivalents
of $8.2 million. Based on its current cash position and the Company’s planned expense run rate, the Company believes that its current
cash balance is sufficient to support its planned expenses, obligations and capital expenditure requirements into Q4 2024.
Total
net revenue includes revenue from diagnostic services performed on a limited basis as an outsourced provider. Total net revenue for
the year ended December 31, 2023 was $0.3 million.
Total
cost of services relate to the costs of processing diagnostic tests of laboratory samples. Total cost of services for the year ended
December 31, 2023 was $0.2 million.
Research
and development expenses for the year ended December 31, 2023 were $4.7 million, compared to $7.8 million in 2022, reflecting lower
engineering costs necessary to support the PPMP platform, as well as lower laboratory costs for fosciclopirox and volasertib.
General
and administrative expenses for the full year 2023 were $10.1 million compared to 5.2 million in 2022, mainly reflecting increased
third-party costs related to the merger completed in October 2023, as well as higher costs associated with being a public company, including
Directors and Officers Insurance (D&O) and stock-based compensation.
Other
Income (Expense), Net for the full year 2023 increased to $3.4 million of other income, net, from an expense of $1.5 million in 2022.
The increase was primarily due to the loss on the conversion of the Series D SAFEs, the increase in the derivative fair value of the
Series C SAFE and redeemable convertible preferred stock warrant liability.
Net
loss for 2023 decreased to $(11.3) million, or a loss of $(3.41) per share on a basic and diluted basis, for the year ended December
31, 2023, versus a net loss of $(14.4) million, or a loss of $(21.97) per share on a basic and diluted basis, for the year ended December
31, 2022.
Outstanding
shares as of April 1, 2024 were approximately 9.0 million.
About
Volasertib
Volasertib
is a PLK-1 inhibitor with demonstrated activity in AML and other tumor types, including solid tumors, with significant unmet medical
need. Building on the performance of volasertib on PPMP, an important and proprietary step during Notable’s targeted in-licensing
strategy and decision making, Notable will utilize PPMP to predict volasertib-responsive patients prior to their treatment, with the
goal of selectively enrolling and treating those predicted responders, increasing volasertib’s response rates and overall patient
outcomes, and fast-tracking volasertib’s remaining clinical development in this patient population. Volasertib was originally developed
and manufactured by Boehringer Ingelheim and previously granted breakthrough therapy designation by the FDA. Notable in-licensed volasertib
and obtained exclusive worldwide development and commercialization rights, except for certain rare pediatric cancers.
About
Notable Labs, Ltd.
Notable
Labs, Ltd. Is a clinical-stage platform therapeutics company developing predictive precision medicines for patients with cancer. Through
its proprietary Predictive Precision Medicines Platform (PPMP), Notable aims to predict whether or not a patient is likely to respond
to a specific therapeutic. The PPMP is designed to identify and select clinically responsive patients prior to their treatment, potentially
fast-tracking clinical development. By continually advancing and expanding the reach of the PPMP across diseases and predicted medical
outcomes, Notable aims to be the leader in predictive precision medicine and revolutionize the way patients seek and receive treatments
that work best for them.
Notable
believes it has created a targeted and de-risked in-licensing strategy to deliver a product’s medical impact and commercial value
faster, with a greater likelihood of success, than traditional drug development. By transforming historical standards of care, Notable
aims to create a dramatically positive impact for patients and the healthcare community. Notable is headquartered in Foster City, California.
Learn more at our website and follow us @notablelabs.
Forward
Looking Statements
This
press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, including but not limited to, express or implied statements regarding Notable’s future operations
and goals; the potential benefits of any therapeutic candidates or platform technologies of Notable; the timing of any clinical milestones
of Notable’s therapeutic candidates; the cash runway of the company; and other statements that are not historical fact. All statements
other than statements of historical fact contained in this communication are forward-looking statements. These forward-looking statements
are made as of the date they were first issued, and are based on the then-current expectations, estimates, forecasts, and projections,
as well as the beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties,
many of which involve factors or circumstances that are beyond Notable’s control. Notable’s actual results could differ materially
from those stated or implied in forward-looking statements due to a number of factors, including but not limited to (i) uncertainties
associated with Notable’s platform technologies, as well as risks associated with the clinical development and regulatory approval
of product candidates, including potential delays in the commencement, enrollment and completion of clinical trials; (ii) risks related
to the inability of Notable to obtain sufficient additional capital to continue to advance these product candidates and any preclinical
programs; (iii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom;
(iv) risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated
to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (v) risks
associated with Notable’s future financial and operating results, including its ability to become profitable; (vi) Notable’s
ability to retain key personnel; (vii) Notable’s ability to manage the requirements of being a public company; (viii) uncertainties
relating to the Israel-Hamas war; (ix) Notable’s ability to obtain orphan drug designation, and the associated benefits, for any
of its drug candidates; (x) Notable’s inability to obtain regulatory approval for any of its drug candidates; and (xi) changes
in, or additions to international, federal, state or local legislative requirements, such as changes in or additions to tax laws or rates,
pharmaceutical regulations, and other regulations. Actual results and the timing of events could differ materially from those anticipated
in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully
described in periodic filings with the U.S. Securities and Exchange Commission (“SEC”), including the factors described in
the section titled “Risk Factors” in the Annual Report on Form 10-K of Notable Labs, Ltd. for the year ended December 31,
2023 as filed with the SEC, and in other subsequent filings with the SEC. You should not place undue reliance on these forward-looking
statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. Notable expressly
disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein
to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such
statements are based.
CONTACTS:
Investor
Relations:
Daniel
Ferry, LifeSci Advisors
C:
+1 (617) 430-7576
E:
daniel@lifesciadvisors.com
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