Peer-reviewed AstroRx data underscore NewcelX (NCEL) stem cell platform

Rhea-AI Filing Summary

NewcelX Ltd. reported that a peer-reviewed study in Stem Cell Reports highlights the therapeutic potential of its AstroRx® stem-cell-derived astrocyte therapy. The work, done with academic collaborators, shows pro‑repair effects in experimental multiple sclerosis models, supporting broader use in chronic demyelinating diseases.

The company frames the results as further validation of its stem cell technology platform, which is intended to generate scalable therapies across multiple indications while it advances lead candidate NCEL‑101 for Type 1 Diabetes. NewcelX also reiterates substantial risks, including going concern doubts, regulatory and clinical uncertainties, and Nasdaq listing and geopolitical risks.

Key Terms

human embryonic stem cells, remyelination, oligodendrocyte progenitor cells, Phase 1/2a clinical trial, +2 more

6 terms

human embryonic stem cells medical

"a clinical-grade human embryonic stem cells (“hESC”)-derived astrocyte therapy"

remyelination medical

"AstroRx® addresses key barriers to remyelination by enhancing myelin debris clearance"

Remyelination is the biological process by which the protective insulating layer around nerve fibers, called myelin, is rebuilt after damage. Like rewrapping the insulation on an electrical wire to restore a signal, successful remyelination can improve nerve function and reduce disability, so therapies that promote it are closely watched by investors for their potential clinical benefit, regulatory interest, and commercial value.

oligodendrocyte progenitor cells medical

"promoting the differentiation of oligodendrocyte progenitor cells (“OPCs”) into mature oligodendrocytes"

Phase 1/2a clinical trial medical

"which recently completed a successful Phase 1/2a clinical trial in amyotrophic lateral sclerosis"

Type 1 Diabetes medical

"developing transformative stem-cell-derived therapies for Type 1 Diabetes"

An autoimmune condition in which the pancreas stops producing insulin, a hormone that lets the body use sugar for energy; without insulin people must manage blood sugar with injections, pumps, or other therapies. For investors, it matters because the lifelong need for medicines, devices, and monitoring creates steady demand, influences healthcare spending and reimbursement decisions, and drives clinical trials and regulatory activity in the diabetes treatment market.

going concern financial

"that our financial position raises substantial doubt about our ability to continue as a going concern"

A going concern is a business that is expected to continue its operations and meet its obligations for the foreseeable future, rather than shutting down or selling off assets. This assumption matters to investors because it indicates stability and ongoing profitability, making the business a more reliable investment. Think of it as believing a restaurant will stay open and serve customers, rather than closing down suddenly.

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Form 6-K: How Foreign Companies Report to the SEC →

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 June 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 June 15, 2026, NewcelX Ltd., a corporation incorporated under the laws of Switzerland, issued a press release titled: “NewcelX Publishes Peer-Reviewed Study Demonstrating Broad Therapeutic Potential of its Stem Cell Technology Platform.” A copy of this press release is furnished herewith as Exhibit 99.1.

1

EXHIBIT INDEX

Exhibit Number		Description of Document
99.1		Press release titled: “NewcelX Publishes Peer-Reviewed Study Demonstrating Broad Therapeutic Potential of its Stem Cell Technology Platform”

2

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: June 15, 2026	By:	/s/ Ronen Twito
		Name:	Ronen Twito
		Title:	Chief Executive Officer

3

Exhibit 99.1

NewcelX Publishes Peer-Reviewed Study Demonstrating Broad
Therapeutic Potential of its Stem Cell Technology Platform

Study published in Stem Cell Reports demonstrates that AstroRx^® - a therapy derived from NewcelX’s platform - addresses key barriers to remyelination with potential to treat chronic demyelinating diseases including MS

Showcases scalability and broad therapeutic potential of the Company’s stem cell therapy platform as it advances a potential cure for type 1 diabetes

ZURICH, Switzerland, June 15, 2026 - NewcelX Ltd. (Nasdaq: NCEL), a clinical-stage regenerative medicine company developing stem-cell-derived therapies, today announced the publication of a peer-reviewed study in Stem Cell Reports, investigating the potential of AstroRx^®, a clinical-grade human embryonic stem cells (“hESC”)-derived astrocyte therapy, which recently completed a successful Phase 1/2a clinical trial in amyotrophic lateral sclerosis (“ALS”), as a novel and translationally relevant cell therapy for multiple sclerosis (“MS”), and other chronic demyelinating diseases. The publication further validates NewcelX’s ability to develop novel cell therapies through its stem cell technology platform, designed to generate scalable therapeutic assets across multiple applications.

The full paper can be found here.

The study, titled “Pro-repair properties of a human embryonic stem cell–derived astrocyte cell therapy in experimental multiple sclerosis,” was developed in collaboration with researchers at several highly regarded institutions, including the Hebrew University of Jerusalem Hadassah Medical School. Data demonstrated that AstroRx^® addresses key barriers to remyelination by enhancing myelin debris clearance, sustaining a pro-repair inflammatory environment, and promoting the differentiation of oligodendrocyte progenitor cells (“OPCs”) into mature oligodendrocytes. These effects were observed both in-vitro and in an in-vivo lysolecithin-induced demyelination model.

“This latest publication showcases the strength of our platform and proof of concept for our stem cell technology, as we aim to deliver innovative solutions across complex diseases. Furthermore, it underscores our ability to advance a broad pipeline of assets while we develop our lead candidate NCEL-101 for the treatment of type 1 diabetes,” said Ronen Twito, Executive Chairman and Chief Executive Officer of NewcelX.

Key findings from the study include the potential for AstroRx^® to:

● enhance myelin debris clearance by microglia,

● support lymphocyte-mediated immune regulation, and

● accelerate oligodendrocyte progenitor cell (“OPC”) differentiation into oligodendrocytes.

About Stem Cell Reports

Stem Cell Reports is an open access forum communicating basic discoveries in stem cell research, in addition to translational and clinical studies. Stem Cell Reports focuses on manuscripts that report original research with conceptual or practical advances that are of broad interest to stem cell biologists and clinicians.

Given the rapidly increasing impact of stem cell research to regenerative medicine and tissue engineering, Stem Cell Reports encourages the submission of manuscripts whose scope bridges these fields of research. The journal also encourages the submission of reports of robust new methodologies with biological significance and/or the potential to advance the application of basic research from the laboratory to the clinic. Stem Cell Reports promotes transparency in stem cell research and related fields of research through the publication of confirmatory findings, negative results, and adverse events.

For further information visit: https://www.cell.com/stem-cell-reports/home

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 its ability to develop novel cell therapies through its stem cell technology platform, designed to generate scalable therapeutic assets across multiple applications, its aim to deliver innovative solutions across complex diseases and its ability to advance a broad pipeline of assets. 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 we may elect to utilize in seeking European Medicines Agency, or EMA, the U.S. Food and Drug Administration, or FDA, and other regulatory approvals; our ability to drive revenue growth, enhance research and development capabilities, and improve financial performance is subject to uncertainties; that our financial position raises substantial doubt about our ability to continue as a going concern; our 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 our 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 our product candidates or whether such trials will be conducted at all; competitive companies, technologies and our industry; the development and commercialization, if any, of any other product candidates that we 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 we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our 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; our 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 our 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

Valter Pinto, Managing Director
KCSA Strategic Communications
newcelx@kcsa.com
212.896.1254

Company Contact

Sarah Bazak
InvestorRelations@newcelx.com

FAQ

What did NewcelX (NCEL) announce in its June 2026 Form 6-K?

NewcelX announced a peer-reviewed study in Stem Cell Reports on its AstroRx® stem-cell-derived astrocyte therapy. The data support AstroRx® as a potential treatment for multiple sclerosis and other chronic demyelinating diseases, reinforcing the company’s broader stem cell platform strategy.

What is AstroRx® in the NewcelX (NCEL) stem cell platform?

AstroRx® is a clinical-grade human embryonic stem cell–derived astrocyte therapy developed by NewcelX. It has completed a Phase 1/2a trial in ALS and, in experimental multiple sclerosis models, showed pro-repair properties that may help overcome key barriers to remyelination.

How does the new study support NewcelX’s (NCEL) stem cell platform?

The study demonstrates that AstroRx® can enhance myelin debris clearance, sustain a pro-repair inflammatory environment, and promote differentiation of oligodendrocyte progenitor cells. NewcelX states this further validates its platform’s ability to generate scalable therapeutic assets across multiple disease applications.

How is NewcelX (NCEL) linking AstroRx® to its Type 1 Diabetes program?

NewcelX says the AstroRx® data showcase the strength and versatility of its stem cell technology platform. Management notes this supports advancing a broad pipeline while the company focuses on NCEL‑101, an hPSC-based cell replacement therapy candidate for Type 1 Diabetes.

What key risks and uncertainties does NewcelX (NCEL) highlight?

NewcelX cites numerous risks, including regulatory-pathway uncertainty, clinical trial delays, products that may never be approved, substantial doubt about its ability to continue as a going concern, Nasdaq listing compliance challenges, intellectual property limits, competitive pressures, and political and security instability, particularly in the Middle East.

Which journal published the NewcelX (NCEL) AstroRx® study and why is it notable?

The AstroRx® study was published in Stem Cell Reports, an open-access journal focused on stem cell research, translational work, and clinical studies. The journal emphasizes conceptual or practical advances, making publication there a notable validation of NewcelX’s preclinical multiple sclerosis research.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE TITLED: "NEWCELX PUBLISHES PEER-REVIEWED STUDY DEMONSTRATING BROAD 15.7 KB