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 May 2026
Commission File Number: 001-39957
NEWCELX LTD.
(Translation of registrant’s name into
English)
Hohstrasse 1, 8302 Kloten
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 May 27, 2026, NewcelX Ltd.,
a corporation incorporated under the laws of Switzerland (the “Company”), issued a press release titled: “NewCelX Ltd.
Submits Pre-IND Package to the FDA for NCEL-101 for the Treatment of Type 1 Diabetes.” A copy of this press release is furnished
herewith as Exhibit 99.1.
The first four paragraphs
of the press release attached to this Form 6-K as Exhibit 99.1 are incorporated by reference into the Company’s Registration Statements
on Form F-3 (File Nos. 333-282788, 333-268690, 333-269220, 333-295770 and 333-284811), filed with the Securities and Exchange
Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports
subsequently filed or furnished.
EXHIBIT INDEX
Exhibit
Number |
|
Description of Document |
| 99.1 |
|
Press release titled: “NewCelX Ltd. Submits Pre-IND Package to the FDA for NCEL-101 for the Treatment of Type 1 Diabetes” |
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: May 27, 2026 |
By: |
/s/ Ronen Twito |
| |
|
Name: |
Ronen Twito |
| |
|
Title: |
Chief Executive Officer |
3
Exhibit 99.1
NewCelX Ltd. Submits Pre-IND Package to the
FDA for NCEL-101 for the Treatment of Type 1 Diabetes
Pre-IND meeting has been scheduled with FDA
to advance type 1 diabetes treatment to First-In-Human clinical trial
ZURICH, Switzerland, May 27, 2026 (GLOBE
NEWSWIRE) -- NewcelX Ltd. (“NewcelX”; Nasdaq: NCEL), a clinical-stage regenerative medicine company
developing stem-cell-derived therapies, today announced the submission of a Pre-Investigational New Drug (“Pre-IND”)
briefing package to the U.S. Food and Drug Administration (“FDA”) to support the proposed First-In-Human
(“FIH”) clinical trial of NCEL-101 in combination with tegoprubart, an investigational immunomodulatory agent being
developed by Eledon Pharmaceuticals (“Eledon”; Nasdaq: ELDN). The submission represents a significant milestone toward
the clinical development of an innovative treatment intended for a potential cure for type 1 diabetes.
NewcelX is seeking to advance NCEL-101, an enriched
stem cell-derived islet product candidate, into clinical studies with Eledon’s investigational anti-CD40L monoclonal antibody, tegoprubart,
serving as the cornerstone of a calcineurin inhibitor-free immunosuppressive regimen. The combination is designed to enable durable graft
survival and function, with the goals of achieving outcomes comparable to donor human islet transplantation and advancing a potential
functional cure for type 1 diabetes. This approach is supported by recently reported results from a 12-patient investigator-initiated
study at University of Chicago Medicine in patients with type 1 diabetes, where tegoprubart-based immunosuppression preserved transplanted
islet function and maintained durable immune protection (Eledon
Announces Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes at UChicago
Medicine).
Tegoprubart has been used as an investigational
immunosuppressive agent in more than 100 transplant recipients across studies conducted under multiple FDA-cleared Investigational New
Drug applications. This body of clinical transplant experience provides important safety, dosing, and immunologic insights that are directly
relevant to islet cell replacement therapies and support the planned advancement of NCEL-101.
A Type B pre-IND meeting has been scheduled with
the FDA for the last week of June. NewcelX plans to discuss NCEL-101 manufacturing, the preclinical (safety/toxicology study) development
plan and FIH clinical trial design.
Ronen Twito, Executive Chairman & CEO of
NewcelX, added, “The Pre-IND meeting for NCEL-101 is a pivotal milestone that underscores our commitment towards a potential
cure for T1D. We are encouraged both by our continued interactions with
the FDA and by the FDA’s recent commitment to streamlining the IND process for T1D innovations.”
About NewcelX
NewcelX is an innovative biopharmaceutical company
focused on developing transformative stem-cell-derived therapies for Type 1 Diabetes. Built on a validated human pluripotent stem cell
(hPSC) platform, the company’s lead program, NCEL-101, is designed to restore functional insulin production through scalable, off-the-shelf
cell replacement. NewcelX is advancing a comprehensive therapeutic approach for Type 1 Diabetes integrating cell therapy, immune protection,
and translational science to address critical unmet medical needs.
Social Media: LinkedIn, Facebook, X, Instagram
Website: www.newcelx.com
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 clinical development of an innovative treatment intended
for a potential cure for type 1 diabetes, advancing NCEL-101 into clinical studies with Eledon’s investigational anti-CD40L monoclonal
antibody, the planned advancement of NCEL-101, the Company’s expectations concerning its pre-IND interactions with the U.S. Food
and Drug Administration (the “FDA”), the timing, scope and outcome of any FDA feedback, the potential initiation, timing,
design and progress of future preclinical studies or clinical trials, the advancement of the Company’s development programs and
the regulatory pathway for its product candidate. 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: the regulatory pathways that NewcelX may elect to utilize in seeking European
Medicines Agency, the FDA, and other regulatory approvals; its ability to drive revenue growth, enhance research and development capabilities,
and improve financial performance is subject to uncertainties; that its financial position raises substantial doubt about its ability
to continue as a going concern; its ability to maintain listing and effectively comply with the listing requirements of the Nasdaq; changes
in technology and market requirements; potential delays or obstacles in launching or completing clinical trials, including its expectations
regarding the timing of commencing further clinical trials, the process entailed in conducting each such trial, including dosages, and
the order of such trials with each of its product candidates or whether such trials will be conducted at all; competitive companies, technologies
and its industry; the development and commercialization, if any, of any other product candidates that it may seek to develop; 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; the scope of protection it is able
to establish and maintain for intellectual property rights covering its product candidates and its ability to operate its business without
infringing the intellectual property rights of others; higher-than-expected product costs; results in the laboratory that do not translate
to clinical success; insufficient patent protection; possible adverse safety outcomes; its ability to establish and maintain strategic
partnerships and other corporate collaborations; risks related to changes in healthcare laws, rules and regulations in the United States
or elsewhere; delays in developing or introducing new technologies, products, or applications; competitive pressures that could reduce
market share or pricing; the overall global political and economic environment in the countries in which we operate; and security, political
and economic instability in the Middle East that could harm its business, including due to the current security situation in Israel. 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, 2025, 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.
Investor Contact
KCSA Strategic Communications
Valter Pinto, Managing Director
PH: (212) 896-1254
NewCelX@kcsa.com
Company Contact
Sarah Bazak
InvestorRelations@newcelx.com
