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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): December 18, 2023
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 |
|
|
, 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
December 18, 2023, Notable Labs, Ltd. (the “Company”) issued a press release announcing the results of the Phase 1b/2a clinical
trial being conducted by CicloMed LLC of fosciclopirox in adult patients with relapsed or refractory acute myeloid leukemia (AML), together
with the predictive accuracy of the data arising from the trial generated by the Company’s Predictive Precision Medicines Platform
(PPMP). 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: |
December
18, 2023 |
By: |
/s/
Thomas A. Bock |
|
|
Name: |
Thomas
A. Bock |
|
|
Title: |
Chief
Executive Officer |
Exhibit
99.1
Notable
Reports Predictive Precision Medicine Platform (PPMP)
Accurately
Predicted Fosciclopirox Trial Outcome
-
PPMP Accurately Predicted Patient Outcomes in Fosciclopirox Phase 2a Leukemia Trial -
-
Predictive Results Further Advance PPMP and Corroborate Outcomes from 4 PPMP Validation Trials -
-
Furthers Opportunity to Accelerate PPMP Use in Front-End Drug Development -
FOSTER
CITY, California, and KANSAS CITY, Missouri, December 18, 2023 – Notable Labs, Ltd. (“Notable”) (Nasdaq:
NTBL), a clinical-stage therapeutic platform company developing predictive precision medicines for cancer patients, and CicloMed,
LLC (“CicloMed”), a developmental-stage pharmaceutical company focusing on unmet medical needs in oncology, today announced
initial safety and efficacy data of fosciclopirox and the performance of PPMP, Notable’s Predictive Precision Medicines Platform,
from the Phase 2a trial in adult patients with relapsed/refractory acute myeloid leukemia, R/R AML (NCT04956042). Fosciclopirox is sponsored
by CicloMed and co-developed by both companies. In the Phase 2a trial, PPMP-predicted patient responses were confirmed by the actual
responses to treatment.
“The
successful outcome prediction means that Notable’s PPMP platform accomplished its goal in this trial,” stated Thomas
Bock, M.D., Chief Executive Officer of Notable. “These data further corroborate and extend our four independent PPMP validation
trials in collaboration with leading medical centers*.”
Fosciclopirox,
a patented, parentally administered prodrug of a commercially available topical antifungal agent, ciclopirox, is being developed for
the treatment of bladder cancer and AML.
This
Phase 2a study was designed to characterize the safety and efficacy of fosciclopirox in R/R AML and, in parallel, to test PPMP’s
ability to predict patient responses to treatment. Patients were not selected for enrollment based on PPMP results and, to avoid potential
bias, PPMP analysis was blinded to the actual patient outcomes during the trial. Clinical efficacy in this heavily pretreated group of
patients was defined by standard criteria in AML medical research and practice.
Eighteen
heavily pre-treated patients were enrolled in the trial with nine patients evaluable for response assessment per-protocol. Fosciclopirox,
administered at the Recommended Phase 2 Dose, was well-tolerated. However, none of the nine evaluable patients achieved a complete response.
Stable disease, over four months, was observed in two evaluable patients.
Importantly,
PPMP predicted that all patients enrolled into this trial would be non-responsive to fosciclopirox. The accuracy of this prediction was
confirmed by the actual patient responses to treatment. These PPMP results indicate that the enrolled patient population was biased towards
non-responsiveness to fosciclopirox and suggest that the negative clinical outcome of this Phase 2a trial may have been avoided if PPMP
had initially been used to selectively enroll only predicted responders. Further analyses are ongoing.
“Obviously,
we would have preferred observing therapeutic responses in this Phase 2a trial in heavily pretreated AML patients” shared Tammy
Ham, Chief Executive Officer of CicloMed. “But based on the PPMP results, we will assess the merits of conducting a prospective
trial in which we use PPMP to identify and selectively enroll patients predicted to respond to fosciclopirox treatment.”
“Once
our PPMP team merged the blinded PPMP and clinical data, we observed that the patients’ PPMP-predicted non-responsiveness to fosciclopirox
was accurate and confirmed by the actual patient responses,” said Joseph Wagner, PhD, Chief Scientific Officer of Notable. “This
additional validation gives us further confidence that PPMP will play a significant role in drug development and suggests PPMP should
be advanced to the front-end of clinical development programs to maximize success and avoid from the start, the risk and cost of enrolling
treatment non-responsive patients.”
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 bio-simulates a cancer treatment and aims to predict whether
or not a patient is likely to respond to that specific therapeutic. Notable’s PPMP is designed to identify and select clinically
responsive patients prior to their treatment and thus fast-track clinical development in this patient population. By continually advancing
and expanding the reach of the PPMP across diseases and predicted medical outcomes, Notable aims to be the leader in precision medicine
and revolutionize the way in which patients seek and receive treatments that work best for them – patient by patient and cancer
by cancer. Notable believes it has created a targeted and de-risked in-licensing strategy to deliver a product’s medical impact
and commercial value faster, higher, and with a greater likelihood of success than traditional drug development. By transforming historical
standards of care, Notable aims to create dramatic 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.
* Blood
Adv, 2020 Jun 23;4(12):2768-2778; ASH Poster (2021) https://notablelabs.com/images/notable/Publications/ASH-MDA-Notable.pdf); Cancers
(Basel), 2022 Dec 18;14(24):6240; AACR 2023 - Cancer Res 2023;83(7_Suppl): Abstract #434
About
CicloMed, LLC
CicloMed
LLC is a developmental-stage pharmaceutical company focusing on unmet medical needs in oncology, and fosciclopirox (formerly Ciclopirox
Prodrug, CPX-POM) is its lead drug development candidate. CicloMed is a subsidiary of BioNovus Innovations LLC, a Kansas City-based firm
committed to investing in individuals and organizations who are transforming healthcare and bringing novel solutions to reality. Portfolio
companies have developed new enabling technologies, pharmaceuticals and delivery models that are transformative. For more information,
visit www.ciclomed.com
For
further information, contact:
CicloMed/BioNovus
partnering: Tammy Ham 816.949.8721
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 were 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
+1
(617) 430-7576, daniel@lifesciadvisors.com
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