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EXCLUSIVE: NewcelX Eyes Accelerated 2026 Execution For Diabetes Drug

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NewcelX Ltd.reported its 2025 financial results, with leadership emphasizing a "transformative year" marked by merger completion, balance sheet improvements, and progress in its lead Type 1 diabetes program, NCEL-101.

Ronen Twito, executive chairman and CEO, said the company is positioning NCEL-101, developed in partnership with Eledon Pharmaceuticals Inc., as its primary long-term value driver.

Twito added that the company's stem cell-derived islet platform, combined with targeted immune protection, represents a differentiated approach aimed at a functional cure for Type 1 diabetes.

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NCEL-101 Development Gains Momentum

NewcelX advanced its flagship NCEL-101 therapy through IND-enabling activities, including regulatory preparation and preclinical planning.

The company also progressed manufacturing readiness, working with CDMO Pluri Inc. on clinical batch preparations.

The pipeline strategy includes combining stem cell-derived islets with tegoprubart to enhance immune protection.

NewcelX Broader Pipeline And Platform Validation

Beyond NCEL-101, NewcelX continued development of AstroRx for ALS and DOXA targeting narcolepsy and other CNS indications, while exploring partnership opportunities.

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The company said prior work on AstroRx—including GMP manufacturing and FDA interactions—helped validate its ability to advance cell therapies. This experience is now informing NCEL-101's development and supporting a broader multi-asset strategy and creating potential non-dilutive partnering opportunities.

Balance Sheet Strengthens With New Financing

In April 2026, NewcelX raised $1.35 million through a private placement, with potential additional proceeds of about $2.0 million from warrant exercises, totaling up to $3.4 million.

The company also retains access to a $25 million equity line of credit.

As of year-end 2025, the balance sheet remained largely free of debt, excluding standard working capital obligations.

Cash and equivalents stood at $2.2 million at year-end.

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Net loss for 2025 was $8.3 million, including $5.7 million in non-cash expenses tied to derivative liability remeasurement, which the company said are not expected to recur.

Operating cash outflow totaled $2.8 million, driven by increased spending on NCEL-101 development and merger-related obligations.

NewcelX 2026 Outlook Centers On Execution

NewcelX expects 2026 to focus on advancing NCEL-101 toward key milestones, expanding collaborations, securing additional funding, and accelerating development following its post-merger integration.

Photo: Shutterstock

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