STEM-PD | Cellular Intelligence

CEO Perspective: A defining moment for Cellular Intelligence

Today we’re sharing a defining moment for Cellular Intelligence. We have entered into an agreement with Novo Nordisk to acquire STEM-PD, a Phase 2-ready allogeneic cell therapy program for Parkinson’s disease. In connection with the transaction, Novo Nordisk is also making a strategic investment in Cellular Intelligence.

The program has an FDA-cleared IND for Phase 2 and Fast Track Designation, following completion of Phase 1/2 dosing in the underlying academic clinical program, STEM-PD. The related academic trial was also highlighted by Nature Medicine in 2024 as one of the 11 clinical trials shaping medicine.

This is more than an asset acquisition.

This deal catapults CI into a Phase 2-ready clinical company and, just as importantly, gives us the clearest possible demonstration engine for our AI-native platform.

It marks the beginning of an AI-native era for cell replacement therapy, one where biology is no longer destiny, but design.

Cell therapy has long held extraordinary promise, but it has also been constrained by complexity. Manufacturing is hard. Biology is context-dependent. Protocol development remains too empirical, too slow, and too dependent on trial and error.

At Cellular Intelligence, we believe this can change.

We are building an AI-native, fully integrated therapeutics company. The same platform that learns how cells respond to signals can help design better protocols, improve manufacturability, optimize functional dose, and deepen our understanding of how development decisions connect to clinical outcomes.

STEM-PD gives us the ideal proving ground for that vision.

It brings together a clinical-stage program in Parkinson’s disease, an area of significant unmet need, with a platform designed to make cell therapy more predictive, scalable, and controllable.

Our central thesis is simple: cell therapy can move from an empirical process into a predictive engineering discipline.

This is the company we set out to build: the defining AI-native, fully integrated cell therapy company.

We are grateful to Novo Nordisk for their trust and confidence, to our investors and advisors for their continued belief, and to the Cellular Intelligence team for the relentless work that made this possible.

This is an extraordinary step forward for the company, for our platform, and most importantly, for the future of cell therapy and the patients it has the potential to one day serve.

Micha Breakstone, Co-Founder & CEO

STEM-PD is an investigational therapy; its safety and efficacy have not been established.

The Disease

Parkinson's is the fastest-growing neurodegenerative disease.

  1. People living with Parkinson's globally: 11.8M
  2. Projected global patients by 2050: ~25M
  3. Diagnosed before age 50, facing 20+ years of disease: 10%
  4. Disease-modifying therapies currently approved: 00

What's At Stake

Current therapies manage symptoms. None restore what is lost.

For decades, treatment for Parkinson's has meant managing what remains, not restoring what is lost. By the time of clinical diagnosis, patients have typically lost more than half of the substantia nigra pars compacta dopaminergic neurons that define the disease.

For the roughly one in ten patients diagnosed before age 50, that means navigating more than two decades of progressive loss with no approved therapies designed to slow it.

STEM-PD starts from a different premise: replacing the dopaminergic neurons lost in Parkinson’s, rather than only managing the symptoms they leave behind.

The Program

Born in academic science. Now in clinical trials.

STEM-PD began as a research collaboration between the University of Cambridge and Lund University, two of the world's leading centers for Parkinson's research. After decades of foundational work, the program was advanced into a first-in-human Phase 1/2 clinical trial funded by Novo Nordisk.

The program has demonstrated cell engraftment and promising safety and tolerability. It is now the first asset stewarded by CI's foundation model, a starting point, not a finish line.

Our Founder's Perspective

"Optimizing and scaling complex cell therapy programs to reach patients globally is exactly the challenge our platform was built to solve."

Micha Breakstone — Co-founder & CEO

The Platform At Work

What changes when AI meets a clinical-stage program.

Cell therapy has long faced a fundamental challenge: the science that works in a lab does not automatically translate to a therapy that reaches millions of people. The manufacturing is too complex, too slow, and too costly to scale.

CI's platform applies its foundation model directly to that problem, optimizing the process parameters that determine whether a cell therapy can be manufactured reliably, at scale, and delivered globally. For STEM-PD, that means accelerating the path from a Phase 2 study to a therapy potentially available to patients worldwide.

The Flywheel

STEM-PD advances the platform. The platform advances STEM-PD.

Every clinical and manufacturing data point generated by STEM-PD feeds back into CI's foundation model, improving its predictions not just for this program, but for every program that follows.

This is what it means to be a platform company with a clinical asset, rather than a clinical-stage company with a platform.

Our CMO's Perspective

"As a neurologist, after seeing too many promising approaches fall short, I find the emerging data in investigational cell therapies genuinely encouraging."

Stem cell-based therapy matters because it reflects a fundamentally different idea, one aimed at replacing lost cellular function, rather than only addressing what remains. For those of us who have worked in Parkinson's disease for a long time, that shift in approach is both scientifically significant and personally meaningful.

Much work remains. But it is encouraging to see the field advancing toward strategies that may expand what is achievable for patients.

Nuno Mendonça, M.D.
Chief Medical Officer

Where the program stands

Learn More

Understand the science behind Cellular Intelligence.

Read the white paper and explore the foundation model driving a new approach to biology.

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Disclaimer: STEM-PD is an investigational product undergoing clinical evaluation. Its safety and efficacy have not been established, and it has not been approved by the FDA, EMA, or any other regulatory authority. Statements on this page about STEM-PD's potential effects refer to investigational use only and are not intended to promote or offer the product for sale.
Nature Medicine Source: Arnold, C., Webster, P. 11 clinical trials that will shape medicine in 2024. Nat Med29, 2964–2968 (2023). https://doi.org/10.1038/s41591-023-02699-5