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Diabetes pioneer Dr. Ricordi joins NewcelX (NCEL) scientific advisory board

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Form Type
6-K

Rhea-AI Filing Summary

NewcelX Ltd., a clinical-stage biotechnology company focused on regenerative cell therapies for type 1 diabetes, reported the appointment of world‑renowned diabetes researcher Dr. Camillo Ricordi to its Scientific Advisory Board.

The company links this hire to its recently completed FDA Type B Pre‑IND meeting for its lead program, NCEL‑101, which it says provided a clear regulatory pathway toward starting clinical trials. Dr. Ricordi brings extensive experience in islet transplantation, stem cell–derived islet replacement and immune modulation, and will advise on NewcelX’s biologic replacement strategy, regenerative medicine platform and collaboration with Eledon Pharmaceuticals.

The press release reiterates standard forward‑looking statement cautions and highlights risks such as regulatory uncertainty, clinical trial timing, technology adoption, intellectual property protection, Nasdaq listing compliance and the company’s financial position, which it states raises substantial doubt about its ability to continue as a going concern.

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Scientific publications 1,250+ publications Dr. Ricordi’s publication record in diabetes and transplantation
Citations 64,000+ citations Dr. Ricordi’s scientific impact cited in literature
h-index h-index of 123 Measure of Dr. Ricordi’s academic influence
Patents 28 awarded patents Dr. Ricordi’s intellectual property portfolio
Pre-IND meeting type FDA Type B Pre-IND Meeting for NCEL-101 providing regulatory pathway toward trials
Years as UM professor Since 1993 Dr. Ricordi’s professorship at University of Miami Miller School of Medicine
Scientific Advisory Board financial
"today announced the appointment of Camillo Ricordi ... to its Scientific Advisory Board."
A scientific advisory board is a group of independent experts—often scientists, clinicians or technical specialists—who give a company guidance on its research, product development and regulatory strategy. For investors, their role is like an external quality check: credible experts can reduce technical risk, improve the chance of regulatory approval or successful products, and boost confidence that management’s science claims are realistic and well-directed.
FDA Type B Pre-IND meeting regulatory
"The appointment follows NewcelX’s recently announced successful FDA Type B Pre-IND meeting for NCEL-101"
regenerative cell therapies medical
"a clinical-stage biotechnology company developing regenerative cell therapies for type 1 diabetes"
type 1 diabetes medical
"developing regenerative cell therapies for type 1 diabetes and other serious diseases"
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.
forward-looking statements regulatory
"This press release contains expressed or implied forward-looking statements within the meaning"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
going concern financial
"that our financial position raises substantial doubt about our ability to continue as a going concern"
Going concern is the accounting assumption that a company will keep operating and meeting its obligations for the foreseeable future. The phrase matters most when a company or its auditors disclose substantial doubt about it, a formal warning that the business may not have enough resources to continue without raising money, restructuring, or selling assets. That language in a filing or press release signals elevated financial risk.
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FAQ

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

NewcelX announced the appointment of diabetes research leader Dr. Camillo Ricordi to its Scientific Advisory Board. The company connects this move to advancing its NCEL‑101 cell therapy program for type 1 diabetes after a successful FDA Type B Pre‑IND meeting.

Who is Dr. Camillo Ricordi and why is he important to NewcelX (NCEL)?

Dr. Camillo Ricordi is a world‑renowned expert in islet transplantation and diabetes cure‑focused research. He invented the automated islet isolation method and has over 1,250 publications, bringing deep scientific and translational experience to support NewcelX’s type 1 diabetes strategy.

What is NewcelX’s NCEL-101 program mentioned in the filing?

NCEL‑101 is NewcelX’s lead stem‑cell‑derived therapy designed to restore insulin production in type 1 diabetes. The company reports a successful FDA Type B Pre‑IND meeting that provided alignment on development strategy and a clearer regulatory pathway toward initiating clinical trials.

What key risks to NewcelX (NCEL) are highlighted in the forward-looking statements?

The company cites risks around regulatory pathways, clinical trial delays, technology acceptance, competition, intellectual property, Nasdaq listing compliance, and costs. It also notes that its financial position raises substantial doubt about its ability to continue as a going concern, among other factors.

How will Dr. Ricordi contribute to NewcelX’s collaboration with Eledon Pharmaceuticals?

The release states that Dr. Ricordi will support NewcelX’s clinical strategy and its collaboration with Eledon Pharmaceuticals. His expertise in immune modulation and cell transplantation is expected to help advance efforts toward a potential functional cure approach for type 1 diabetes.

What does NewcelX (NCEL) focus on as a company?

NewcelX is an innovative biopharmaceutical company developing stem‑cell‑derived therapies for type 1 diabetes. It uses a human pluripotent stem cell platform and aims to offer scalable, off‑the‑shelf cell replacement integrated with immune protection and translational science to address unmet medical needs.

 

 

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 July 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 July 8, 2026, NewcelX Ltd., a corporation incorporated under the laws of Switzerland (the “Company”), issued a press release titled: “NewcelX Appoints World-Renowned Diabetes Cure-Focused Pioneer, Dr. Camillo Ricordi, to Scientific Advisory Board.” A copy of this press release is furnished herewith as Exhibit 99.1.

 

The first, second and fifth 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. 333-282788333-268690333-269220333-295770 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.

 

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EXHIBIT INDEX

 

Exhibit
Number
  Description of Document
99.1   Press release titled: “NewcelX Appoints World-Renowned Diabetes Cure-Focused Pioneer, Dr. Camillo Ricordi, to Scientific Advisory Board”

 

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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: July 8, 2026 By: /s/ Ronen Twito
    Name:  Ronen Twito
    Title: Chief Executive Officer

 

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Exhibit 99.1

 

NewcelX Appoints World-Renowned Diabetes Cure-Focused Pioneer, Dr. Camillo Ricordi, to Scientific Advisory Board

 

The appointment follows NewcelX’s recently announced successful FDA Type B Pre-IND
meeting for NCEL-101 providing a clear regulatory pathway toward clinical trials

 

Dr. Ricordi to support advancement of NewcelX’s Type 1 Diabetes program and
strategic collaboration with Eledon Pharmaceuticals

 

ZURICH, Switzerland – July 8, 2026 – NewcelX Ltd. (Nasdaq: NCEL), a clinical-stage biotechnology company developing regenerative cell therapies for type 1 diabetes and other serious diseases, today announced the appointment of Camillo Ricordi, M.D., F.N.A.I., to its Scientific Advisory Board.

 

Dr. Ricordi is internationally recognized as one of the world’s foremost authorities in diabetes cure-focused research, beta-cell replacement, and cellular transplantation. With more than 1,250 scientific publications, over 64,000 citations, an h-index of 123, and numerous pioneering contributions to the field of islet transplantation, Dr. Ricordi has played a central role in advancing cell-based approaches for type 1 diabetes worldwide.

 

“Dr. Ricordi’s appointment to our Scientific Advisory Board represents an important validation of our scientific strategy and our commitment to advancing potentially transformative therapies for patients living with type 1 diabetes,” said Ronen Twito, Chief Executive Officer and Chairman of NewcelX. “His unparalleled expertise and global reputation in diabetes research will be invaluable as we continue to advance our clinical development programs and strengthen our position within the diabetes and transplantation communities.”

 

The appointment follows NewcelX’s recently announced successful FDA Type B Pre-IND meeting for NCEL-101, during which the Company received constructive FDA feedback and alignment on its proposed development strategy, providing a clear regulatory pathway toward initiating clinical trials. Dr. Ricordi’s appointment further strengthens NewcelX’s scientific leadership as the Company advances into its next stage of development.

 

Dr. Ricordi currently serves as the Chief of the Division of Cellular Transplantation, Department of Surgery, Director of the Cell Transplant and NABTU Regenerative Medicine Center, and Director Emeritus of the Diabetes Research Institute (DRI). Since 1993, he has been the Professor of Surgery, Distinguished Professor of Medicine, and Professor of Biomedical Engineering, Microbiology and Immunology at the University of Miami Miller School of Medicine. He has also spent three decades as the Medical Director of the DRI cGMP Advanced Human Cell and Biologic Product Manufacturing Facility. He was the founding President of the Cell Transplant Society, President of the International Association for Pancreas and Islet Transplantation (IPITA) and served on the boards of The Transplantation Society and the American Society of Transplant Surgeons. He has also served on the FDA Biologic Response Modifiers Advisory Committee, several NIH study sections, and as an advisor or reviewer for international funding agencies.

 

 

 

 

“I believe regenerative medicine and cell-based therapies have the potential to fundamentally transform the treatment paradigm for type 1 diabetes,” said Dr. Camillo Ricordi. “The combination of stem cell-derived islet replacement and targeted immune modulation represents one of the most promising approaches currently being pursued in the field. I am pleased to join NewcelX and look forward to supporting the advancement of its clinical strategy and its collaboration with Eledon Pharmaceuticals toward a potential functional cure for T1D.”

 

As a member of the Scientific Advisory Board, Dr. Ricordi will actively advise and support the clinical translation of NewcelX’s biologic replacement strategy and regenerative medicine platform.

 

About Camillo Ricordi, M.D.

 

Camillo Ricordi, M.D., is world-renowned for his work in cellular transplantation for the treatment of diabetes. He serves as the Chief of the Division of Cellular Transplantation, Department of Surgery, Director of the Cell Transplant and NABTU Regenerative Medicine Center, and Director Emeritus of the Diabetes Research Institute (DRI). Since 1993, he has been the Professor of Surgery, Distinguished Professor of Medicine, and Professor of Biomedical Engineering, Microbiology and Immunology at the University of Miami Miller School of Medicine.

 

Dr. Ricordi invented the automated method (the Ricordi Chamber) for isolating large numbers of insulin-producing islet cells from the human pancreas - now the global standard for clinical islet transplantation - and performed the first series of successful clinical islet allotransplants to reverse diabetes. He chaired the steering committee of the first NIH-funded, FDA Phase 3 multicenter islet transplant trial, completed in 2017, and led the team that performed the first transplants of a bioengineered endocrine pancreas within a 3D resorbable scaffold. He has served as the Medical Director of the NIH-funded DRI cGMP Advanced Human Cell and Biologic Product Manufacturing Facility for three decades.

 

He currently serves as Steering Committee Co-Chair and UM Principal Investigator for the Vertex stem cell–derived islet transplant program (VX-880) and is advancing a first-in-human trial with iTolerance of islet transplantation with a tolerance-inducing microgel, without chronic immunosuppression. He has also served on the FDA Biologic Response Modifiers Advisory Committee, several NIH study sections, and as an advisor or reviewer for international funding agencies.

 

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Dr. Ricordi was the founding President of The Cure Alliance and Chairman of the Diabetes Research Institute Federation, coordinating and promoting cure-focused research among leading institutions worldwide. He was also the founding President of the Cell Transplant Society, President of the International Association for Pancreas and Islet Transplantation (IPITA), and served on the boards of The Transplantation Society and the American Society of Transplant Surgeons.

 

His honors include the World Prize in Surgery (2001), the American Diabetes Association’s Outstanding Scientific Achievement Award (2002), induction into the Association of American Physicians (2010) and the National Academy of Inventors (2018), and Knighthood from the President of Italy. He ranked as the world’s leading expert in islet cell transplantation for the decade 2008–2018, according to Expertscape.

 

Dr. Ricordi has authored over 1,250 publications cited more than 64,000 times (h-index 123) and holds 28 awarded patents. In 2023, he published The Healthspan Code, followed in 2025 by Therapeutic Revolution.

 

Dr. Ricordi completed his medical degree at the University of Milan.

 

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 

 

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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 Prof. Ricordi’s expected contributions to NewcelX. 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

 

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Filing Exhibits & Attachments

1 document