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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 9, 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 9, 2024, Notable Labs, Ltd. (the “Company”) issued
a press release regarding the presentation, at the American Association for Cancer Research (AACR 2024) conference being held in San Diego,
California, of the design plan for the Company’s Predictive Precision Medicine Platform (PPMP)-Enabled Phase 2 Trial with volasertib,
in combination with decitabine, in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML). 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
9, 2024 |
By: |
/s/
Thomas A. Bock |
| |
|
Name: |
Thomas A. Bock |
| |
|
Title: |
Chief Executive Officer |
Exhibit
99.1
Notable
Labs Presents the Design Plan for the PPMP-Enabled Phase 2 Trial with Volasertib for Relapsed/Refractory AML at AACR 2024
| ● |
Poster
outlines the parameters for developing a flow-cytometry-based PPMP as a companion diagnostic to predict volasertib responders, based
on a proof-of-concept study using 41 primary acute myeloid leukemia (AML) samples |
| |
|
| ● |
Plans
to incorporate a dose optimization prelude to enhance patient response and tolerability also outlined in the poster |
FOSTER
CITY, CA, April 9, 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 the design for the PPMP-enabled Phase 2 trial with volasertib, in combination
with decitabine, in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) at the American Association for Cancer Research
(AACR 2024) being held in San Diego, CA (Poster abstract 5178).
“We
are very pleased to share more data regarding our clinical program and proprietary platform with the oncology community at AACR 2024.
Presenting a summary of the Phase 2 volasertib study design in AML provides us with an opportunity to highlight the potential for the
PPMP to effectively predict responders, and enroll an responder-enriched patient population, in our upcoming clinical program. Our
clinical program will incorporate the co-development of a companion diagnostic test,” said Thomas Bock, M.D., Chief Executive Officer
of Notable.
Joseph
Wagner, Ph.D., Chief Scientific Officer of Notable, commented, “The abstract highlights technical features of volasertib on Notable’s
PPMP, including our method to develop a companion diagnostic test and define a cut-off value to predict responders. Based on the robust
results of a 41-sample proof-of-concept study summarized in the poster, we are optimistic about the potential for PPMP to improve patient
selection and lead to a strong Phase 2 study. In addition, we look forward to implementing a dosing optimization plan, including standardized
use of best supportive care and introduction of body surface area-based dosing, to enhance patient responses and tolerability.”
Poster
Highlights:
Guided
by a predictive ex vivo test: Bringing the PLK1 inhibitor volasertib back into the clinic for venetoclax-HMA relapsed/refractory acute
myeloid leukemia patients
Overview:
While prior studies of volasertib demonstrated an approximately 30% complete response/complete response with incomplete count recovery
(CR/CRi) rate in de novo AML patients in combination with cytarabine, development was halted in part due to toxicity potentially related
to the use of a flat dose, rather than patient-specific, body-surface area (BSA) dosing. Notable Labs provided an updated plan for the
design of an open label Phase 2 study, including a dose optimization plan aimed at reducing toxicity while maintaining efficacy and an
overview of study objectives and endpoints. As part of the study, a companion diagnostic assay to predict responders will be co-developed
utilizing the Company’s proprietary flow-cytometry-based PPMP.
Method:
Ex vivo flow cytometry experiments evaluated the treatment of volasertib on 41 primary acute myeloid leukemia (AML) samples collected
from peripheral blood or bone marrow. Dose-response profiles consistent with volasertib’s role as a cell cycle inhibitor were observed.
To obtain a preliminary concentration of volasertib for patient stratification, Notable compared the ex vivo resistant blast fractions
(leukemic cells surviving ex vivo treatment with volasertib) at several concentrations with the areas under the volasertib dose-response
curves (AUCs), assuming that AUCs would correspond most accurately with the clinical responses.
Results:
The results suggest a strong correlation between volasertib resistant fractions treated with 31.6 and 100 nM of volasertib and AUCs,
which could represent a suitable metric to stratify patients into responders and non-responders. These preliminary metrics predict that
32-33% of de novo patients and 25% of R/R AML patients would be predicted to be responders if they were treated with volasertib.
Poster
information:
| Session
Category: |
Clinical
Research |
| Session
Title: |
Predictive
Biomarkers |
| Session
Date and Time: |
Tuesday
Apr 9, 2024, 9:00 AM - 12:30 PM PT |
| Location:
|
Poster
Section 45 |
| Poster
Board Number: |
19 |
| Published
Abstract Number: |
5178 |
The
full poster will be posted to the company’s website in the Scientific Presentations & Publications page in the News section
of the website shortly after the event.
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 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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