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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 8, 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. ☐
On
April 8, 2024, Notable Labs, Ltd. (the “Company”) issued a press release regarding the presentation of data related to innovations
in the use of cryopreserved samples in the Company’s Predictive Precision Medicine Platform (PPMP) assay at the American Association
for Cancer Research (AACR 2024) conference being held in San Diego, California. A copy of the press release is filed herewith as Exhibit
99.1.
| 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
8, 2024 |
By: |
/s/
Thomas A. Bock |
| |
|
|
Name:
Thomas A. Bock
Title: Chief Executive Officer |
Exhibit
99.1
Notable
Labs Presentation of Data Related to Innovations in the Use of Cryopreserved Samples in the PPMP Assay at AACR 2024 Expands the Potential
of the Platform
FOSTER
CITY, CA, April 8, 2024 – Notable Labs, Ltd. (Nasdaq: NTBL) (“Notable”
or the “Company”), a clinical-stage precision oncology company developing a new class of cancer therapies identified by its
Predictive Precision Medicine Platform (PPMP), today presented data related to innovations in the use of cryopreserved samples in the
PPMP assay at the American Association for Cancer Research (AACR 2024) being held in San Diego, CA (Poster abstract 2548).
“We
are very pleased to share the result of our innovative sample handling study with the cancer community at AACR 2024. The ability to derive
a high-quality assessment of the response to treatment based on the results of cryopreserved samples is an important innovation. It has
been previously thought that frozen samples could not be effectively thawed and used for cell viability assays. Based on the data presented
at AACR, Notable now has the potential to develop partnerships to assess new treatment regimens, including combination therapies, using
Notable’s PPMP platform and archived, cryopreserved samples thawed according to our protocols and proprietary media compositions,”
said Thomas Bock, M.D., Chief Executive Officer of Notable. “We hope this opens new opportunities to apply our PPMP to a broad
range of archived samples and therapeutics to unlock value and new treatment options for patients with cancer.”
Joseph
Wagner, Ph.D., Chief Scientific Officer of Notable, added, “As we are ready to initiate the Phase 2 program with volasertib in
Q2 2024, we are dedicated to maintaining a focus on innovation for our PPMP. The careful evaluation of sample handling protocols, presented
at AACR 2024, makes our PPMP more comprehensive and enhances the opportunity to study and apply it more broadly. As we continue to execute,
we look forward to further demonstrating the potential of PPMP and partner with biopharmaceutical companies and innovators to provide
potential new treatment options for patients with cancer.”
Summary
of Data and Findings for Notable’s Sample Handling Study:
Overview:
The study was designed to evaluate the potential use of cryopreserved samples as an alternative to fresh samples for predicting treatment
response in acute myeloid leukemia (AML) using Notable’s PPMP.
| ● |
Cryopreserved
samples are known for exhibiting low sample viability and cell recovery, rendering their practical utilization challenging |
| ● |
Notable
adapted an existing methodology to process cryopreserved patient-derived leukemia cells to investigate their use as an alternative
to fresh samples in the PPMP assay |
Method:
First, a method was established using freshly isolated white blood cells (WBCs) from AML patients (<2 days from sample collection).
A fraction of these cells was cryopreserved. Both fresh and cryopreserved cells (after thawing and culturing) were assessed on the PPMP
and results compared. Second, the established method was applied to cryopreserved samples (from a biobank) collected from AML patients
prior to their treatment with chemotherapy (cytarabine plus idarubicin). Results obtained on the PPMP were compared to the clinical responses
experienced by the patients after treatment with cytarabine and idarubicin.
Results:
For the method development study, ex vivo responses to 3 different compounds (venetoclax, 5-azacytidine and decitabine) were assessed
after culturing of the cryopreserved cells for 24- and 48-hour post thaw using two different media (“A” and “B”).
There was a strong correlation (R2 from 0.77 to 0.92) for venetoclax and 5-azacytidine between the results obtained with fresh
vs. frozen samples. For the biobank samples treated with cytarabine and idarubicin, culture media A and B show a similar dose-response
behavior. Importantly, the PPMP correctly predicted clinical responders (complete remission) and non-responders (refractory).
While
Notable will continue to evaluate and validate these sample handling methodologies, these data open the door to the use of cryopreserved
samples from retrospective cohorts.
Poster
information: Retrospective prediction of clinical response to standard-of-care therapies in acute myeloid leukemia by an ex vivo drug
sensitivity assay using cryopreserved primary samples
| Session
Category: |
|
Clinical
Research |
| |
|
|
| Session
Title: |
|
Real-World
Biomarkers |
| |
|
|
| Session
Date and Time: |
|
Monday
Apr 8, 2024 9:00 AM - 12:30 PM PT |
| |
|
|
| Location:
|
|
Poster
Section 45 |
| |
|
|
| Poster
Board Number: |
|
8 |
| |
|
|
| Published
Abstract Number: |
|
2548 |
The
full poster will be posted to the company’s website in the Scientific Presentations & Publications page in the Investors section
of the website shortly after the event.
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 platform 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 Quarterly Report on Form 10-Q of Notable Labs, Ltd. as filed with the SEC on November
14, 2023, 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
+1
(617) 430-7576
daniel@lifesciadvisors.com
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