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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): February 22, 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
February 22, 2024, Notable Labs, Ltd. (the “Company”) issued a press release updating its Phase 2 clinical trial plan for
volasertib. 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:
February 22, 2024 |
By:
|
/s/
Thomas A. Bock |
|
Name: |
Thomas
A. Bock |
|
Title: |
Chief
Executive Officer |
Exhibit
99.1
Notable
Advances Volasertib Phase 2 Program Utilizing Proprietary Predictive Precision Medicine Platform-Guided Enrollment
● | Predictive
Precision Medicine Platform (PPMP) utilized to enrich program for clinically responding patients
and reduce the risk, time, and cost of drug development |
● | Volasertib
Phase 2 trial initiation in relapsed/refractory acute myeloid leukemia anticipated in Q2
2024, and first data in Q4 2024 |
● | Relapsed/refractory
acute myeloid leukemia constitutes an urgent unmet medical need with typical treatment response
rates of 15 percent and a median survival of 6 months or less |
FOSTER CITY, CA, February 22, 2024 – Notable Labs, Ltd. (Nasdaq:
NTBL) (“Notable”, “Notable Labs”), a clinical-stage therapeutics platform company developing a new class
of cancer therapies based on its Predictive Precision Medicine Platform (PPMP), today announced the advancement of its volasertib Phase
2 program utilizing PPMP to enrich the study population for clinical responders. Notable is developing its lead drug asset volasertib
with its proprietary PPMP for patients with relapsed/refractory acute myelogenous leukemia (r/r AML).
“PPMP’s recently reported, 100% accurate prediction of fosciclopirox’s
clinical trial outcome has allowed us to eliminate an entire 30-patient cohort from the planned volasertib program, and further validated
our PPMP-guided development strategy to target responding patients, improve patient outcomes and reduce the risk, time, and cost of drug
development,” said Thomas Bock, M.D., Chief Executive Officer of Notable Labs.
“We in-licensed volasertib because of its robust clinical experience
in Boehringer Ingelheim’s expansive Phases 1-3 program and our PPMP data that distinguished predicted volasertib-responders from
predicted non-responders based on samples from patients with AML. We therefore believe that PPMP will focus volasertib’s development
on clinically responding patients, boost its clinical response rate and enhance patient outcomes,” continued Dr. Bock. “The
open label design of our Phase 2 trial will enable us to provide frequent data updates, and initiate a subsequent Phase 3 trial at the
earliest possibility.”
Joseph Wagner, Ph.D., Chief Scientific Officer of Notable, added, “In
our PPMP-guided Phase 2 trial, we are additionally leveraging important learnings from the extensive post-hoc analysis of the original
Phase 2 and 3 trials. This analysis suggests that standardizing best supportive care and introducing body surface area-based dosing are
likely to enhance patient responses and tolerability. We are going to include and evaluate these refinements in a small all-comers dose
optimization prelude, expected to begin in Q2 2024 and be completed in Q4 2024, prior to enrolling PPMP-predicted responders.”
Volasertib
Phase 2 program: Summary of expected near-term clinical milestones
● | Volasertib
IND filing: Q1 2024 |
● | Phase
2 program initiation: Q2 2024 |
● | Prelude
data on dose optimization: Q4 2024 |
● | Enrollment
of first PPMP-selected patient: Q4 2024 |
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
the Volasertib Phase 2 trial
Notable’s single-arm, open-label Phase 2 study of volasertib combined
with decitabine in r/r AML patients is designed to achieve two objectives: i) to confirm the optimized tolerability profile suggested
by volasertib’s Phase 3 post-hoc analysis through the introduction of body-surface area-based volasertib dosing and standardizing
best supportive care, and ii) to evaluate the clinical impact of volasertib treatment on selectively enrolled r/r AML patients who are
predicted to clinically respond, based on PPMP testing of their blood or bone marrow samples (PPMP-predicted responders). Parallel primary
endpoints are i) a positive predicted response rate and ii) a per-protocol response assessment of complete remission and overall survival.
The Phase 2 program is designed to include a non-selective dose optimization
prelude expected to enroll a small cohort of all-comers patients with r/r AML. This dose optimization prelude will evaluate the use of
standardized best supportive care and body surface area-based dosing prior to beginning the prospective PPMP-based patient selection.
Data on patient safety, tolerability, and efficacy, including overall safety, response and duration of response, will be evaluated.
About
Notable Labs, Ltd.
Notable
Labs 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 www.notablelabs.com 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 combined 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 Registration Statement of Vascular Biogenics Ltd. on Form S-4, as filed
with the SEC on September 1, 2023, 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
C:
+1 (617) 430-7576
E:
daniel@lifesciadvisors.com
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