Kadimastem

What Kadimastem does

Kadimastem Ltd. is an Israeli clinical-stage biotechnology company founded in 2009 that develops allogeneic, off-the-shelf cell therapies derived from human embryonic stem cells (hESCs). Its platform differentiates hESCs into functional cell types for diseases with significant unmet need. The company's lead clinical asset is AstroRx, an hESC-derived astrocyte cell therapy administered intrathecally for Amyotrophic Lateral Sclerosis (ALS), which has completed a Phase 1/2a trial in Israel showing 45–71% slowing of disease progression and received FDA Orphan Drug Designation and FDA IND approval for a US multi-site Phase 2a trial. Its second asset, IsletRx, comprises hESC-derived pancreatic islet cells producing insulin and glucagon for insulin-dependent (Type 1) diabetes, currently in preclinical development with a successful pre-IND FDA meeting and an active collaboration with iTolerance (ITOL-102 program, supported by a BIRD Foundation grant) to enable transplantation without immunosuppression.

The business model is pre-revenue: Kadimastem does not yet sell any commercial product. Revenue, when it materializes, is expected to come from one-time licensing or product sales of FDA-approved cell therapies targeting ALS and Type 1 diabetes patients, distributed through hospital and clinical trial sites. Manufacturing is conducted at GMP standards internally and through CDMO partner Pluri Inc., with technology transfer completed for both AstroRx and IsletRx. The company has historically funded operations through multiple small private placements and rights offerings on the Tel Aviv Stock Exchange (ticker KDST), and on October 30, 2025, completed a merger with NLS Pharmaceutics Ltd. to form Nasdaq-listed NewCelX Ltd. (ticker NCEL), in which former Kadimastem shareholders hold 84.4%. The company has 11–50 employees, is headquartered at the Weizmann Science Park in Ness Ziona, Israel, and is led by a management team featuring founder Prof. Michel Revel (Israel Prize laureate and developer of Rebif), CEO Asaf Shiloni, and a board including former Given Imaging Chairman Doron Birger and former Teva CEO Ron Miron.

Name

Kadimastem

Legal name

Kadimastem Ltd.

Website

https://kadimastem.com

Company type

Public

Founded year

2009

Operating status

Acquired

Headcount range

11–50 employees

Short description

Kadimastem is an Israeli clinical-stage biotech developing off-the-shelf allogeneic cell therapies from human embryonic stem cells, targeting ALS (AstroRx, FDA IND-approved Phase 2a) and Type 1 diabetes (IsletRx, preclinical), and now operating as Nasdaq-listed NewCelX (NCEL) following its October 2025 merger with NLS Pharmaceutics.

Ownership category

akta.pro rank

Product category

Regenerative Medicine

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical Preparation Manufacturing (325412)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Cell Therapy Developers (Allogeneic/Off-the-shelf) (HLAAABAB)

akta.pro secondary industries

Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL), Cell Therapy Manufacturing Services (GMP, autologous/allogeneic) (HLAAAKAC)

Keywords

• Allogeneic cell therapy
• Stem cell therapeutics
• Regenerative medicine platform
• Human embryonic stem cells
• Clinical stage biotechnology

Headquarters

HQ city

Ness Ziona

HQ country

Israel

HQ region

Middle East

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Cell Therapy Product Revenue: Pre-revenue clinical stage company. Expected to generate revenue from FDA-approved cell therapy products for ALS and diabetes upon successful clinical trials and regulatory approvals.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Kadimastem is a clinical-stage cell therapy company that develops allogeneic, off-the-shelf stem cell-based therapeutics derived from Human Embryonic Stem Cells (hESCs). Its two lead programs are AstroRx, an intrathecally administered astrocyte cell therapy for ALS that has received FDA Orphan Drug Designation and IND approval for a U.S. Phase IIa trial, and IsletRx, a stem cell-derived pancreatic islet cell therapy for insulin-dependent diabetes in preclinical development. Manufacturing is performed at GMP-certified facilities, including via CDMO partner Pluri Inc., with the technology protected by a multi-jurisdiction patent portfolio.

Product overview

Kadimastem is a clinical-stage cell therapy company with a proprietary platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional allogeneic cell products for the treatment of unmet medical needs. The company operates two lead clinical and preclinical programs: AstroRx®, an astrocyte cell therapy in Phase IIa development for ALS (with FDA IND approval granted), and IsletRx, a stem cell-derived pancreatic islet cell therapy in preclinical development for Type 1 Diabetes (with a successful pre-IND FDA meeting completed). The company also has a frozen (second-generation) formulation of AstroRx® in development to support future commercial-scale manufacturing. Kadimastem's platform technology was developed at Prof. Michel Revel's laboratory at the Weizmann Institute of Science and is protected by an international patent portfolio.

Differentiator

Problem solved

Functional benefit

Products and services

• AstroRx An off-the-shelf allogeneic astrocyte cell therapy product composed of human embryonic stem cell (hESC)-derived astrocytes. AstroRx is administered via intrathecal injection and is intended to support motor neuron survival in Amyotrophic Lateral Sclerosis (ALS) patients through multiple mechanisms of action. AstroRx has received FDA Orphan Drug Designation and completed a Phase I/IIa clinical trial in Israel, with a multi-site U.S. Phase IIa trial approved by FDA (IND) and planned to evaluate repeated dosing every three months.
• IsletRx An allogeneic stem cell-derived pancreatic islet cell therapy composed of functional beta-like cells that produce and release insulin and glucagon in response to blood glucose levels. IsletRx is being developed for the treatment of insulin-dependent (Type 1) diabetes, with the goal of restoring natural glycemic control. A pre-IND INTERACT meeting with FDA was completed with positive feedback, and preclinical in-vivo safety studies are underway to support a first-in-human Phase 1 trial. The ITOL-102 program combines IsletRx with iTolerance's iTOL-100 immune tolerance technology under a BIRD Foundation grant to enable transplantation without immunosuppression.

Quantifiable outcome

• 45-71% reduction in disease progression rate in ALS patients (ALSFRS-R score improvement)
• +2 more outcomes

Segments2 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature4 records

Partnerships

Five partnerships are on record, tiered core and major.

• NLS Pharmaceutics Ltd.coreStrategic or Co-development Partner · 30 October 2025Completed merger between NLS Pharmaceutics and Kadimastem to form NewcelX Ltd. Kadimastem shareholders own 84.4% of combined company. Merger enables listing on Nasdaq under ticker 'NCEL'. Consolidates cell therapy and drug discovery platforms.
• iTolerance Inc.coreStrategic or Co-development Partner · 29 October 2025Collaboration on ITOL-102 program for Type 1 Diabetes. Combines Kadimastem's IsletRx with iTolerance's immune tolerance technology (iTOL-100) to enable allogeneic cell transplantation without immunosuppression. Supported by BIRD Foundation grant of approximately $1 million.
• TargetGene Biotechnologies Ltd.coreTechnology or Integration · 27 October 2025Strategic collaboration via MOU to develop next-generation gene-edited cell therapies. Combines Kadimastem's cell therapy platforms with TargetGene's DNA-guided gene-editing platform for enhanced treatment efficacy for ALS and diabetes.
• Pluri Inc.majorTechnology or Integration · 23 October 2025GMP-certified CDMO partner for technology transfer and clinical manufacturing. Technology transfer, training, and product release certification completed for both AstroRx and IsletRx manufacturing.
• Hadassah Medical CentermajorStrategic or Co-development PartnerClinical trial site for Phase 1/2a AstroRx trial in Israel, conducted at Hadassah Ein Karem, Jerusalem under Prof. Mark Gotkine. Principal investigator site for ALS research.

Scale indicators11 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Vertex Pharmaceuticals: Vertex acquired ViaCyte and is developing VX-880, a stem cell-derived islet cell therapy for Type 1 Diabetes — the same disease space as Kadimastem's IsletRx — and represents the most advanced direct competitor in T1D cell therapy.
• BlueRock Therapeutics: A Bayer-owned allogeneic pluripotent stem cell therapy company developing dopaminergic neuron therapies for Parkinson's, with a comparable off-the-shelf cell therapy platform to Kadimastem's hESC-derived approach.
• ViaCyte: Pioneer in stem cell-derived pancreatic islet cell therapies for T1D (now under Vertex) and the most direct historical peer to Kadimastem's IsletRx program in mechanism and target indication.
• Lineage Cell Therapeutics: Develops allogeneic, off-the-shelf cell therapies using its proprietary cell therapy platforms across neurology and oncology — closely aligned business model and manufacturing approach to Kadimastem.
• Fate Therapeutics: Develops off-the-shelf, iPSC-derived cell therapies with a multiplexed engineering platform; comparable to Kadimastem's allogeneic hESC differentiation approach and broad cell therapy pipeline.
• Sana Biotechnology: Focused on hypoimmune allogeneic cell therapies (including for type 1 diabetes), sharing Kadimastem's goal of avoiding immunosuppression in cell transplantation.
• Sigilon Therapeutics: Developed encapsulated cell therapies for type 1 diabetes; was acquired by Eli Lilly. Direct technological adjacency to Kadimastem's IsletRx in T1D cell therapy.

Emerging players

• Pluri Inc. Israeli cell therapy company that is both a clinical-stage developer (placenta-derived cell therapies) and serves as the GMP CDMO partner manufacturing Kadimastem's AstroRx and IsletRx.

Broad incumbents

• Biogen: Developer of Qalsody (tofersen) for SOD1-ALS, an approved ALS therapy that competes for neurologist attention and reimbursement in the same patient population Kadimastem targets with AstroRx.
• Cytokinetics: Late-stage ALS drug developer (reldesemtiv) sharing the same physician channel and ALS patient population Kadimastem is pursuing with AstroRx.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/KadimastemLTD
• Facebookfacebook.com/Kadimastem
• LinkedInlinkedin.com/company/kadimastem
• Instagraminstagram.com/kadimastem/?__pwa=1

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds9 records

Investors5 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Kadimastem