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— Pipeline

PIPELINE.

Our vision is to be the trusted engine for regeneration — advancing restorative medicines through world-class technology and deep therapeutic partnerships.

Explore our iPSC-derived programs

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— Pipeline at a glance

Three programs, one regenerative engine.

TFG-001 · Parkinson's

TFG-002 · Liver

TFG-003 · Undisclosed

Next milestone

00Program

01Discovery

02Preclinical

03IND-enabling

04Phase I

05Phase II

06Phase III

TFG-001

Parkinson's · DA neurons

3D Dopaminergic Microtissue

FIH · 2027

FIH 2027 →

TFG-002

Liver Diseases · hepatic

3D Hepatic Microtissue

TFG-003

Undisclosed

In discovery

— Our pipeline

We believe we can unlock regenerative cell therapy across many therapeutic areas, including diseases such as Parkinson’s, liver diseases, type 1 diabetes and other diseases of the central nervous system.

We know the immense potential to cure chronic and degenerative diseases, but traditional approaches often struggle with scale, efficiency and integration.

Our proprietary and partnered pipeline leverages the power of C-Stem™, generating unique iPSC-derived 3D microtissues that act as functional, ready-to-transplant tissues facilitating efficient integration and fast onset.

Through our existing programs and partnerships, we are on track to help millions of people live healthier, brighter futures.

Learn more about C-Stem™

— Lead program

TFG-001

Our lead program is in Parkinson’s disease (TFG-001)

In Parkinson’s disease, an estimated 60–80% of dopaminergic neurons are already lost before motor symptoms even appear. The nigrostriatal pathway degenerates, destroying the essential wiring that connects dopamine-producing neurons to movement control. While chemical dopamine replacements (like levodopa) can manage symptoms, they cannot restore the spatial precision, feedback loops, or dynamic regulation of a healthy brain network.

To achieve true functional restoration, it is not enough to simply replace lost cells; the brain’s circuitry must be rebuilt. This is called reinnervation and transplanted cells need to survive, mature, extend new axons into the host tissue, and form functional synapses.

Scientific evidence shows that the extent of reinnervation is directly linked to the therapeutic efficacy of the graft. TFG-001 has been engineered to conquer this biological challenge.

Learn more on reinnervation here →

TFG-001 is a first-in-class 3D neural microtissue. Composed of both mature dopaminergic (DA) neurons and DA progenitors, this 3D format is designed to enhance post-transplantation integration and reinnervation.

Unlike single-cell suspensions, which must re-establish connections with each other and the host tissue, its pre-organized 3D dopaminergic network, comprising both progenitors and neurons, facilitates more efficient integration and markedly improves reinnervation capacity

Key Data to Date

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— Best-in-class

Next generation best-in-class

3D neural microtissues (dopaminergic neurons and progenitors).

— Rapid release

Rapid dopamine release

48hvs 28 days reported benchmarks

The graph summarizes the level of dopamine release obtained with the Drug Product, after thawing, 2 days of subculturing and 1 hour of stimulation in KCl-rich medium.

This graph highlights batch-to-batch consistency, including for the batch produced after tech transfer, as well as the stability of this potency 1 year after production.

— Superior efficacy

Extensive striatal reinnervation

In vivo studies show average accumulated intensity of the TH signal after TFG-001 transplantation, across the experimental groups. In this graph, brighter color indicates higher signal intensity.

— Motor recovery

Accelerated Motor Recovery

13weeks · vs 17–28 reported

This rapid recovery is fully sustained long-term.

The graph shows the efficacy in months with cryopreserved microtissues showing functional recovery at 13 weeks in preclinical rat models (green line).

— Off-the-shelf

True "Off-The-Shelf" Viability

Cryopreserved 3D microtissue with no delay in time-to-effect vs fresh product, maintaining dose-dependent recovery.

— Publications

Learn more about our platform and Parkinson’s through our publications

Biomaterials Neurotherapeutics

— Next Milestone

2027

TFG-001 is on track for a First-In-Human (FIH) clinical trial application (CTA) by 2027. We are actively exploring co-development opportunities for the co-development and commercialization of TFG-001

— Pipeline program

TFG-002

TFG-002 for Liver Disease

There is a critical, unmet need for off-the-shelf hepatic solutions to support patients experiencing serious liver diseases such as acute liver failure. Extending patient waiting times for organ transplants or ensuring hepatic function while the liver naturally regenerates is a global healthcare priority.

The liver features highly complex tissue architecture that cannot be accurately replicated by traditional 2D flat cell cultures. Our solution relies on ready-to-transplant 3D hepatic liver microtissues derived from induced pluripotent stem cells (iPSCs), which perfectly suit the complex architectural needs of the liver.

Key Achievements & Data to Date

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— Scale barrier

Overcoming the Scale Barrier

>200Bcells per batch · target

Treating liver disease requires massive doses—over 5 billion cells per patient. Our C-Stem™ amplification technology is uniquely designed to meet this demand, on track to producing >200 billion cells per batch required for commercial and clinical viability without compromising cell quality.

The graph demonstrates that C-Stem™ enabled a higher amplification rate leading to a higher cell yield at the end of the differentiation. In red: capsule; in blue: 2D static culture.

— Quality

High-quality, fully functional hepatic microtissue

Engineered to deliver the structural and functional fidelity required for therapeutic application.

The graph shows the albumin secretion, which is detected earlier and at a higher level in the microtissues differentiated in capsules than in the cells generated in 2D. In addition, the CYP3A4 activity and urea production at day 30 of the differentiation are higher in the microtissues differentiated in capsules than in the cells generated in 2D.

— Characterization

Comprehensive characterization

Validated across the criteria required for clinical translation.

The hepatic microtissues in graph show organ-like cellular organization that recapitulates morphological and functional features of a liver, composed of cells with characteristic cubical morphology and hepatic functions (albumin production, glycogen) and those of cholangiocytes (CK19-positive cells) forming biliary structures.

— Function

Comparable to primary human hepatocytes

Functional performance comparable to primary human hepatocytes with C-Stem promoting the microtissue functionality and formation of organized hepatic microtissues

— Partnership

We are open to exploring partnership opportunities for co-development in liver diseases.

— Our promise

The trusted platform for regenerative medicine.

— Partner with us

Co-develop the future of regenerative medicine.

We are actively exploring co-development opportunities for the co-development and commercialization of TFG-001 — and for targets across the brain, heart, liver, and pancreas.

Partner with us → Discover C-Stem™

Bordeaux Boston

— Full references

(Full references):

Hiramatsu, S. et al. Cryopreservation of Induced Pluripotent Stem Cell-Derived Dopaminergic Neurospheres for Clinical Application. JPD 12, 871–884. https://doi.org/10.3233/JPD-212934
Kirkeby, A. et al. Preclinical quality, safety, and efficacy of a human embryonic stem cell-derived product for the treatment of Parkinson’s disease, STEM-PD. Cell Stem Cell 30, 1299-1314.e9. https://doi.org/10.1016/j.stem.2023.08.014
Park, S. et al. Preclinical and dose-ranging assessment of hESC-derived dopaminergic progenitors for a clinical trial on Parkinson’s disease. Cell Stem Cell 31, 25-38.e8. https://doi.org/10.1016/j.stem.2023.11.009
Piaoo, J et al. Preclinical Efficacy and Safety of a Human Embryonic Stem Cell-Derived Midbrain Dopamine Progenitor Product, MSK-DA01. Cell Stem Cell 28, 217-229.e7. https://doi.org/10.1016/j.stem.2021.01.004
Nicolas Prudon et al Bioreactor-produced iPSCs-derived dopaminergic neuron-containing neural microtissues innervate and normalize rotational bias in a dose-dependent manner in a Parkinson rat model https://pubmed.ncbi.nlm.nih.gov/39353832/

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