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

Rhea-AI Summary

NewcelX (Nasdaq: NCEL) reported positive results from an international collaborative study published Jan 12, 2026 in Diabetology testing engineered scaffolds that incorporate decellularized human pancreatic extracellular matrix (ECM) to support delivery of stem cell–derived islets for Type 1 Diabetes.

The study found that ECM‑integrated scaffolds yielded implanted islet functional performance comparable to encapsulated islets delivered without a scaffold, and highlighted biomaterial design and tissue microenvironment as key to enabling retrievable, immune‑sparing delivery approaches. Funding came from AFDR, the National Stem Cell Foundation of Australia, and Breakthrough T1D.

Positive

• Published peer‑reviewed study showing ECM scaffold supports islet function comparable to non‑scaffold encapsulation
• Findings support removable, retrievable delivery configurations that could reduce need for chronic immunosuppression
• Study backed by multiple reputable funders including AFDR, National Stem Cell Foundation of Australia, and Breakthrough T1D

Negative

• Results are preclinical/research study findings and have not yet been demonstrated in human clinical trials
• Press release contains no quantitative efficacy or safety metrics from the published study

Argus Jan 12 session

+13.70% close to close 23.4x rel. volume Open Argus

Details

News Market Reaction – NCEL

On Jan 12, the day this news came out, NCEL closed 13.70% above the previous close. That session’s volume was 23.4x the stock’s average daily volume.

Data tracked by StockTitan Argus for the Jan 12 session.

Historical Context

5 past events · Latest: Jan 05

5 events

1. Jan 05

   Advisory board hire

   24h Move

   +6.7%

   Diabetes expert joined advisory board to guide IsletRx toward clinical trials.

2. Dec 11

   IP expansion

   24h Move

   -21.8%

   Publication of DOXA patent application in China expanding neurology IP footprint.

3. Nov 17

   Advisory board hire

   24h Move

   -0.3%

   ALS and neuromuscular specialist joined to advise AstroRx and neurology programs.

4. Nov 06

   Advisory board hire

   24h Move

   -11.7%

   Neuroimmunology expert added, supporting ALS and diabetes programs post-merger.

5. Nov 04

   Strategic update

   24h Move

   +10.0%

   CEO letter set clinical milestones and outlined combined cell therapy/neuroscience strategy.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

extracellular matrix, decellularized, pluripotent stem cell–derived islets, immunosuppression, +1 more

5 terms

extracellular matrix medical

"examined the use of engineered scaffolds incorporating extracellular matrix (ECM) derived"

A network of proteins and other molecules that sits outside cells and gives tissues their shape, strength and a medium for cells to send signals and move — like the scaffolding and wiring inside a building. Investors care because changes to this matrix play a major role in diseases, wound healing and tissue repair, making it a common target for drugs, medical devices and diagnostics that can drive regulatory decisions and commercial value.

decellularized medical

"ECM derived from a decellularized human pancreas."

Decellularized describes biological tissue or an organ that has had all its living cells removed, leaving behind a nonliving structural scaffold like a stripped-down frame of a house. For investors this matters because that scaffold can be reused as a implant or tissue-engineering platform with lower risk of immune rejection, different manufacturing and regulatory hurdles, and potential to create reproducible, high-value medical products.

pluripotent stem cell–derived islets medical

"encapsulated pluripotent stem cell–derived islets within a removable delivery system."

Clusters of insulin-producing cells grown from pluripotent stem cells, designed to act like the pancreas’s islets that regulate blood sugar. Think of them as lab-made replacement parts or tiny factories that can produce insulin on demand; they matter to investors because successful development and approval could create large markets for diabetes treatment, drive therapy-related revenues, and carry clinical, manufacturing and regulatory risks that affect company value.

immunosuppression medical

"intended to eliminate the need for chronic immunosuppression medications."

Immunosuppression is the lowering of the immune system’s ability to fight infections and other threats, either from drugs, medical treatments, or underlying disease. For investors it matters because products or conditions that cause immunosuppression change a drug’s safety profile, patient eligibility, regulatory hurdles and market size—think of it like turning down a building’s alarm system, which can reduce false alarms but raises the risk of real break‑ins and affects downstream costs and demand.

cell therapy medical

"a realistic cell therapy for type 1 diabetes," said Professor Bernard Tuch"

Cell therapy uses living human or animal cells as the medicine: cells are collected, sometimes grown or altered, and then given to a patient to repair, replace, or boost damaged tissue or immune function. For investors, cell therapies can transform markets because they may offer one-time or highly effective treatments that command premium prices, but they also carry high development, manufacturing and regulatory costs and commercial risks, like building a custom factory rather than making a simple product.

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ZURICH, Jan. 12, 2026 /PRNewswire/ -- 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.

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SOURCE NewcelX Ltd.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did NewcelX (NCEL) announce on January 12, 2026 about islet delivery research?

NewcelX announced a peer‑reviewed study showing ECM‑integrated scaffolds supported stem cell‑derived islet function comparable to encapsulated islets, suggesting retrievable, immune‑sparing delivery potential.

How do the study results affect NewcelX's IsletRx program (NCEL)?

The results align with IsletRx design goals by supporting scaffold and microenvironment strategies intended to enhance engraftment and retrievability without systemic immunosuppression.

Who collaborated and funded the study published in Diabetology referenced by NewcelX (NCEL)?

Collaborators included University of Technology Sydney, University of Wisconsin–Madison, Monash University, Queensland University of Technology and AFDR; funding came from AFDR, National Stem Cell Foundation of Australia matched donors, and Breakthrough T1D.

Do the January 12, 2026 results mean NewcelX (NCEL) has a ready clinical therapy for Type 1 Diabetes?

No; the announcement reports research‑stage positive results that support development but do not constitute demonstrated safety or efficacy in human clinical trials.

Will NewcelX (NCEL) need immunosuppression for its stem cell‑derived islet approach according to the study?

The study supports designs aimed at eliminating chronic systemic immunosuppression by using biomaterials and retrievable delivery, but clinical confirmation is still required.