UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of January 2026 (Report No. 2)
Commission File Number: 001-39957
NEWCELX LTD.
(Translation of registrant’s name into
English)
The Circle 6
8058 Zurich, Switzerland
(Address of principal executive office)
Indicate by check mark whether the registrant files
or will file annual reports under cover of Form 20-F or Form 40-F:
☒
Form 20-F ☐ Form 40-F
CONTENTS
On January 12, 2026, NewcelX
Ltd., a corporation incorporated under the laws of Switzerland, issued a press release titled: “NewcelX Announce Positive Results
from International Collaborative Study Exploring Advanced Biomaterial Approaches for Stem Cell–Derived Islet Delivery in Type 1
Diabetes Without Immune Suppression.” A copy of this press release is furnished herewith as Exhibit 99.1.
EXHIBIT INDEX
Exhibit
Number |
|
Description of Document |
| 99.1 |
|
Press release titled: “NewcelX Announce Positive Results from International Collaborative Study Exploring Advanced Biomaterial Approaches for Stem Cell–Derived Islet Delivery in Type 1 Diabetes Without Immune Suppression” |
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, thereunto
duly authorized.
| |
NewcelX Ltd. |
| |
|
| Date: January 12, 2026 |
By: |
/s/ Ronen Twito |
| |
|
Name: |
Ronen Twito |
| |
|
Title: |
Chief Executive Officer |
Exhibit 99.1
NewcelX Announce Positive Results from International
Collaborative Study Exploring
Advanced Biomaterial Approaches for Stem Cell–Derived Islet Delivery in Type 1 Diabetes
Without Immune
Suppression
Zurich, Switzerland – January 12th – NewcelX Ltd. (Nasdaq:
NCEL) (“NewcelX” or the “Company”), a clinical-stage biotechnology company advancing regenerative medicine solutions,
today reported the results of an international collaborative research study investigating advanced biomaterial strategies to support the
delivery and function of stem cell–derived islets for the treatment of Type 1 Diabetes.
The peer reviewed study, published in Diabetology, a journal dedicated
to diabetes research, conducted in collaboration with research groups from the University of Technology Sydney, the University of Wisconsin–Madison,
Monash University, the Queensland University of Technology, and the Australian Foundation for Diabetes Research (AFDR), examined the use
of engineered scaffolds incorporating extracellular matrix (ECM) derived from a decellularized human pancreas.
The work evaluated whether ECM integration could support the
function of encapsulated pluripotent stem cell–derived islets within a removable delivery system. The study results demonstrated
that when ECM was incorporated into the scaffold, implanted islets exhibited functional performance comparable to encapsulated islets
delivered without a scaffold. These findings suggest that biomaterial design and tissue microenvironment play a critical role in supporting
islet function and may enable safer, retrievable delivery configurations for future therapeutic development.
The research was supported through a Type 1 Diabetes research initiative
led by the Australian Foundation for Diabetes Research, which had received donor matched funding for the published study from the National
Stem Cell Foundation of Australia. Moreover, it has received dedicated funding from Breakthrough T1D (formerly JDRF), the leading global
type 1 diabetes research and advocacy organization, to further develop the underlying model based on the study results.
“This research contributes to our understanding of how advanced
biomaterials and tissue microenvironments can support engineered islet function,” said Prof. Michel Revel, Chief Scientific Officer
of NewcelX. “The findings are consistent with the scientific principles underlying our diabetes program, which aims to combine
scalable stem cell–derived islets with strategies to enhance engraftment and retrievability intended to eliminate the need for chronic
immunosuppression medications.”
“We are delighted that it has been possible to progress our goal
of developing a realistic cell therapy for type 1 diabetes,” said Professor Bernard Tuch, Chief Scientific Officer of AFDR,
“with the continuing support of our international and national partners”.
Type 1 Diabetes represents NewcelX’s primary therapeutic focus,
and the Company is directing significant scientific and development resources toward advancing cell-based solutions in this area. The
study aligns with NewcelX’s scientific focus on combining stem cell biology with delivery and protection strategies to support functional
insulin-producing cell therapies. IsletRx is NewcelX’s investigational stem cell–derived islet therapy designed to restore
insulin production in individuals with insulin-dependent diabetes. The program integrates proprietary cell differentiation protocols with
immune-protective and delivery-oriented design features, with the goal of achieving functional insulin secretion without the need for
systemic immunosuppression.
“Type 1 diabetes is a central focus of NewCelX’s development
strategy,” said Ronen Twito, Executive Chairman and CEO of NewCelX. “The positive results from this international collaborative
study contribute to the continued advancement of our technologies and help guide our ongoing development efforts as we move toward the
clinical trial.”
About NewcelX Ltd.
NewcelX Ltd. (Nasdaq: NCEL) is a biotechnology company developing cell-based
and small-molecule therapies for neurodegenerative and metabolic diseases. The Company’s integrated platform combines advanced stem-cell
technologies, biomaterials, and neuroscience expertise to support scalable therapeutic solutions for conditions such as Amyotrophic Lateral
Sclerosis (ALS) and Type 1 Diabetes. NewcelX is headquartered in Zurich, Switzerland, with research and development operations in Ness
Ziona, Israel.
Social Media: LinkedIn, Facebook, X,
Instagram
Website: www.newcelx.com
Investor & Media Contacts
Sarah Bazak, Investors relations
InvestorRelations@newcelx.com
About Australian Foundation for Diabetes Research (AFDR)
AFDR is a not-for-profit company established to develop a cell therapy
suitable for most people with type 1 diabetes. To this end it is championing a bioengineered approach to deliver insulin-producing
cells without recipients having to take anti-rejection drugs.
Forward-Looking Statements
This press release contains expressed or implied forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. For example, NewcelX
is using forward-looking statements when it discusses the continued advancement of its technologies and its ongoing development efforts
as its move toward the clinical trial. These forward-looking statements and their implications are based on the current expectations of
the management of NewcelX and are subject to a number of factors and uncertainties that could cause actual results to differ materially
from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially
from those described in the forward-looking statements: changes in technology and market requirements; potential delays or obstacles in
launching or completing clinical trials; products that may not be approved by regulatory agencies; technologies that may not be validated
or accepted by the scientific community; the inability to retain or attract key employees; unforeseen scientific difficulties with products
in development; higher-than-expected product costs; results in the laboratory that do not translate to clinical success; insufficient
patent protection; possible adverse safety outcomes; legislative changes; delays in developing or introducing new technologies, products,
or applications; and competitive pressures that could reduce market share or pricing. Except as otherwise required by law, NewcelX does
not undertake any obligation to publicly release revisions to these forward-looking statements to reflect events or circumstances after
the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting
the Company is contained under the heading “Risk Factors” in its Annual Report on Form 20-F for the year ended December 31,
2024, filed with the U.S. Securities and Exchange Commission (“SEC”) and available at www.sec.gov, as well as
in subsequent filings made by NewcelX, including under the heading “Risk Factors” in its proxy statement/prospectus filed
with the SEC on November 6, 2025.
