NewcelX Announces Strategic Collaboration with Eledon Pharmaceuticals to Advance NCEL-101 Program for Type 1 Diabetes

Rhea-AI Summary

NewcelX (Nasdaq: NCEL) announced a collaborative research agreement with Eledon Pharmaceuticals (Nasdaq: ELDN) to evaluate combination strategies pairing NewcelX's lead stem-cell-derived islet program, NCEL-101, with Eledon's anti-CD40L antibody tegoprubart (AT-1501).

The collaboration leverages clinical experience from >100 transplant patients treated with tegoprubart and aims to support durable, immune-protected islet replacement, potentially clarifying regulatory pathways and accelerating NCEL-101 development toward pivotal milestones.

Positive

• Collaboration to integrate NCEL-101 with tegoprubart (AT-1501)
• Eledon brings clinical experience from over 100 transplant patients
• Agreement aims to accelerate timelines and clarify regulatory pathway

Negative

• No clinical efficacy or safety data for the NCEL-101 + tegoprubart combination disclosed
• No financial terms or commercial value of the collaboration were disclosed

Argus Mar 9 session

+4.32% close to close Open Argus

Details

News Market Reaction – ELDN

In the Mar 9 session, ELDN gained 4.32%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement details a collaboration integrating NewcelX’s NCEL-101 stem-cell-derived islets wi...

Analysis

This announcement details a collaboration integrating NewcelX’s NCEL-101 stem-cell-derived islets with Eledon’s anti-CD40L monoclonal antibody tegoprubart, supported by experience in over 100 transplant patients. It reinforces Eledon’s strategy across kidney, islet, and xenotransplantation. Recent filings show substantial R&D investment and prior financing to fund operations. Key factors to watch include clinical data from combination approaches, regulatory feedback, and how this partnership meshes with previously outlined tegoprubart development milestones.

Key Figures

Transplant patients treated: over 100 patients Transplant procedures referenced: more than 100 procedures Q3 2025 net loss: $17.5 million +5 more

Transplant patients treated

over 100 patients

Clinical experience with tegoprubart across transplant settings

Transplant procedures referenced

more than 100 procedures

Eledon transplant experience cited in NCEL-101 collaboration

Q3 2025 net loss

$17.5 million

Quarter ended September 30, 2025

9M 2025 net loss

$35.2 million

First nine months of 2025

Liquid resources

$93.4 million

Cash and short-term investments at September 30, 2025

Recent financing

$57.5 million

Financing expected to fund operations into 2Q 2027

Public offering shares

15,152,485 shares

Common stock in November 2025 offering

Estimated net proceeds

$46.5 million

From November 2025 underwritten public offering

Historical Context

5 past events · Latest: Mar 04

5 events

1. Mar 04

   Conference participation

   24h Move

   +4.4%

   Announcement of participation in Leerink Partners 2026 Global Healthcare Conference.

2. Feb 05

   Conference participation

   24h Move

   +11.2%

   Planned fireside chat at Guggenheim Emerging Outlook: Biotech Summit 2026.

3. Jan 23

   Clinical data update

   24h Move

   -4.0%

   24‑month Phase 1b kidney transplant data for tegoprubart showing no rejection or graft loss.

4. Jan 08

   Business & pipeline update

   24h Move

   +0.0%

   2025 milestones, Phase 2 BESTOW data, islet and xenotransplant results, and financing/outlook.

5. Dec 01

   Conference participation

   24h Move

   -6.1%

   Participation in the 37th Annual Piper Sandler Healthcare Conference.

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

Key Terms

stem-cell-derived islets, anti-CD40L, monoclonal antibody, investigational new drug (IND), +1 more

5 terms

stem-cell-derived islets medical

"Collaboration Integrates Stem-Cell-Derived Islets with Targeted Immune Modulation"

Clusters of insulin-producing cells grown from stem cells to mimic the pancreas’s natural islet cell groups; they are intended as replacement “parts” to restore blood-sugar control in people with diabetes. For investors, they matter because successful lab-to-patient production and approval could create a large therapeutic market, but outcomes depend on clinical results, manufacturing scale-up, regulatory clearance and long-term safety — factors that drive valuation and risk.

anti-CD40L medical

"Eledon's investigational anti-CD40L monoclonal antibody, tegoprubart (AT-1501)"

Anti-CD40L is a lab-made antibody designed to bind and block CD40 ligand, a protein on certain immune cells that helps drive inflammation and immune activation. For investors, drugs that target this pathway can reduce harmful immune responses in autoimmune disease, prevent organ-rejection after transplant, or modulate cancer immunity, so progress or safety issues in anti-CD40L programs can strongly affect a biotech’s value much like a key engine determining a car’s performance and reliability.

monoclonal antibody medical

"investigational anti-CD40L monoclonal antibody, tegoprubart (AT-1501)"

A monoclonal antibody is a laboratory-made protein designed to recognize and attach to a specific target in the body, such as a disease-causing substance or cell. It functions like a highly precise lock-and-key tool, helping to treat or detect illnesses. For investors, companies developing monoclonal antibodies can represent promising opportunities in the healthcare sector, especially as these treatments often address unmet medical needs.

investigational new drug (IND) regulatory

"developed under multiple U.S. Food and Drug Administration–cleared Investigational New Drug (IND) applications"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

graft survival medical

"Integrating targeted immune modulation with NCEL-101 is intended to support durable graft survival"

Graft survival measures how long a transplanted organ, tissue, or engineered product continues to work in the recipient without failing or needing removal. Think of it as the lifespan of a replacement part inside the body. For investors, graft survival is a key clinical and commercial signal: longer survival reduces repeat procedures and ongoing care, improves patient outcomes, and supports stronger reimbursement, market adoption, and the valuation of therapies, devices, or services tied to transplantation.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Collaboration Integrates Stem-Cell-Derived Islets with Targeted Immune Modulation

ZURICH, Switzerland, March 9, 2026 /PRNewswire/ -- NewcelX Ltd. ("NewcelX") (Nasdaq: NCEL), a clinical-stage company advancing stem-cell-derived therapies for Type 1 Diabetes, today announced a collaborative research agreement with Eledon Pharmaceuticals, Inc. ("Eledon") (Nasdaq: ELDN), a clinical-stage immunology company with a focus on transplant medicine.

The collaboration is designed to advance combination strategies integrating NewcelX's lead program, NCEL-101, with Eledon's investigational anti-CD40L monoclonal antibody, tegoprubart (AT-1501), with the goal of supporting durable, immune-protected islet replacement and advancing a potential functional cure for Type 1 Diabetes.

Eledon's tegoprubart is a next-generation anti-CD40L monoclonal antibody designed to modulate immune activation pathways central to T-cell–mediated transplant rejection. The collaboration leverages clinical experience from over 100 transplant patients treated with tegoprubart, including patients in kidney, heart and diabetes-related transplant settings, developed under multiple U.S. Food and Drug Administration–cleared Investigational New Drug (IND) applications. This extensive transplant experience provides clinically informed insights and data relevant to cell replacement therapies, and could potentially lead to a clearer regulatory pathway for NCEL-101 while streamlining the development program. Integrating targeted immune modulation with NCEL-101 is intended to support durable graft survival comparable to outcomes observed with donor human islets (see press release link).

Importantly, NCEL-101 remains NewcelX's core therapeutic product, designed to address the shortage of functional insulin-producing cells through scalable, off-the-shelf manufacturing. The immune modulation component is intended to enhance durability and graft survival of the cells.

Professor Michel Revel, MD, PhD, CSO of NewcelX: "The collaboration marks an important strategic milestone for NewcelX, enhancing its execution-focused clinical programs and broadening collaboration with established leaders in immune biology and transplant medicine".

The collaboration is anticipated to accelerate timelines, establish a well-defined regulatory pathway, and enhance development visibility, supporting NewcelX's strategy to advance its clinical programs efficiently toward pivotal milestones.

Ronen Twito, Executive Chairman & CEO of NewcelX, added: "Collaborating with Eledon Pharmaceuticals represents a meaningful milestone of our product and a strategic step forward for NewcelX. Leveraging Eledon's extensive transplant experience across more than 100 procedures provides us with clinically grounded insight that potentially supports a clearer regulatory pathway and a more efficient development plan for NCEL-101. Our focus is to translate this advantage into disciplined execution and long-term shareholder value."

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 how this collaboration is designed to advance combination strategies integrating NCEL-101 with Eledon's investigational anti-CD40L monoclonal antibody, tegoprubart (AT-1501), advancing a potential cure for Type 1 Diabetes, how the collaboration is anticipated to accelerate timelines, establish a well-defined regulatory pathway, and enhance development visibility, NewCelX's strategy to advance its clinical programs efficiently toward pivotal milestones, and creating long-term shareholder value. 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.

Investor & Media Contacts

Sarah Bazak, Investors relations
InvestorRelations@newcelx.com

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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 about its NCEL-101 program on March 9, 2026?

They announced a collaborative research agreement with Eledon to study NCEL-101 combined with tegoprubart. According to NewcelX, the work aims to integrate immune modulation to support durable, immune-protected islet replacement and advance clinical development timelines.

How does Eledon's tegoprubart factor into NewcelX's NCEL-101 development (ELDN, NCEL)?

Tegoprubart is an anti-CD40L antibody intended to modulate transplant-related immune activation. According to Eledon and NewcelX, prior use in over 100 transplant patients could inform regulatory and clinical strategies for NCEL-101.

Will the NewcelX and Eledon collaboration change NCEL-101 timelines or regulatory plans?

The companies say the collaboration is expected to accelerate timelines and establish a clearer regulatory pathway. According to NewcelX, combining targeted immune modulation could streamline development toward pivotal milestones.

Did NewcelX disclose financial terms or commercial milestones for the Eledon collaboration (NCEL, ELDN)?

No financial terms or deal value were disclosed in the announcement. According to the companies, the release describes research collaboration scope but does not provide payment, equity, or milestone details.

What clinical evidence supports using tegoprubart with NCEL-101 for Type 1 Diabetes?

Support cited includes tegoprubart experience in over 100 transplant patients across kidney, heart, and diabetes-related settings. According to the announcement, that clinical experience may provide insights for cell replacement therapy development.