NewcelX Ltd.

NewcelX Ltd. announced the publication of a peer-reviewed study in Stem Cell Reports, demonstrating the broad therapeutic potential of its stem cell technology platform. The study focused on AstroRx®, an hESC-derived astrocyte therapy, showing its ability to address key barriers to remyelination in multiple sclerosis (MS) and other chronic demyelinating diseases. This validates the company's platform for developing scalable cell therapies, while NewcelX continues to advance its lead candidate NCEL-101 for type 1 diabetes.

NewcelX AG has issued a notice for its ordinary shareholders' meeting scheduled for June 30, 2026, in Zurich. The agenda includes several key items such as the re-election of the independent proxy and auditor, approval of the 2025 statutory financial statements, and an advisory vote on the 2025 compensation report. Shareholders will also vote on the appropriation of the balance sheet results for 2025, which indicates a significant net loss. Additionally, proposals cover the discharge of the Board of Directors and Executive Management, re-election of Board members and the Compensation, Nomination and Governance Committee, and approval of compensation amounts for the Board and Executive Management. The meeting will also address ordinary capital increases through six tranches, each up to CHF 50,000, with subscription rights excluded, and proposed amendments to the company's Articles of Association concerning the capital band and conditional share capital.

NewcelX Ltd. announced the submission of a Pre-Investigational New Drug (Pre-IND) briefing package to the FDA for NCEL-101, its stem cell-derived islet product candidate. This submission aims to support a First-In-Human clinical trial for the treatment of Type 1 Diabetes, utilizing NCEL-101 in combination with Eledon Pharmaceuticals' tegoprubart. A Pre-IND meeting with the FDA is scheduled for the last week of June to discuss manufacturing, preclinical plans, and trial design, marking a significant step towards a potential functional cure for the disease.

NewcelX Ltd. announced the submission of a Pre-Investigational New Drug (Pre-IND) briefing package to the FDA and has scheduled a Pre-IND meeting for the last week of June. This meeting is a pivotal step to advance NCEL-101, an enriched stem cell-derived islet product, into a First-In-Human clinical trial for type 1 diabetes. The treatment combines NCEL-101 with Eledon Pharmaceuticals' tegoprubart, aiming for a potential functional cure for type 1 diabetes.

NewcelX Ltd. reported a net loss of $8.3 million for the period ended December 31, 2025, with cash and cash equivalents at $2.2 million. The company is accelerating the development of NCEL-101, its Type 1 Diabetes treatment, in collaboration with Eledon Pharmaceuticals, aiming for IND-enabling milestones in 2026. NewcelX also strengthened its balance sheet by closing a financing of up to $3.4 million and appointing Julien Boisdron, MD, to its Scientific Advisory Board. The company expects 2026 to be a year of significantly accelerated execution, including expanding strategic collaborations and pursuing additional financing.

NewcelX Ltd. announced its financial results for the period ended December 31, 2025, alongside significant corporate highlights. The company secured up to $3.4 million in financing, including $1.35 million in cash and $2 million from warrants, and maintains access to a $25 million Equity Line of Credit, resulting in a substantially debt-free balance sheet. NewcelX is accelerating the development of its flagship Type 1 Diabetes program, NCEL-101, in collaboration with Eledon Pharmaceuticals, and strengthened its scientific leadership with a new Scientific Advisory Board appointment, aiming for accelerated execution in 2026.