Pipeline & Roadmap — A Platform Beyond ALS

A Platform, Not a Single Drug

One mechanism. A pipeline of neuroimmune disease.

Because SELtx™ rebalances the immune system rather than targeting one molecule, it extends to any condition that shares the same inflammatory pathway.

Primary focus

ALS

Preparing for first-in-human IRB trials with leading U.S. institutions, built on validated preclinical results and preserved motor function in ALS models.

First indication IRB trial path Validated preclinical data

Alzheimer's

The same immune rebalancing applies directly to Alzheimer's pathology — a core long-term target.

Multiple Sclerosis

MS is driven by immune dysfunction at the root — exactly the class of disease SELtx™ is designed for.

Parkinson's

Neuroinflammation drives Parkinson's progression; the platform targets that shared pathway.

Selected cancers

Immune modulation opens the door to oncology applications under active investigation.

The Opportunity

A multi-indication market measured in the tens of billions.

One platform, several large patient populations opening on a staggered timeline.

$17.9B–$68B

Multi-indication opportunity, 3–10 years

~34,000

ALS patients (U.S.), 2–3 yr horizon

~1M

MS & Parkinson's patients, 5–10 yr

Countries with granted patents

Addressable patient population by horizon

ALS~34,000 · 2–3 yrs

MS & Parkinson's~1,000,000 · 5–10 yrs

Alzheimer's<8 million · Ultimate target · 8–12 yrs

Relative scale of addressable populations as indications open over time.

The Roadmap

From scientific insight to human impact.

A decade of research, structured around milestones — each one de-risking the path to patients.

Pre-2022

Discovery

Immune dysfunction identified as a core driver of ALS. SELtx™ conceived; first patents filed and granted in the U.S., Japan, and internationally.

2023 – 2024

Proof of concept

Closed-loop device v1.0 built and tested. Treated SOD1 ALS mice maintained motor function versus controls — a significant improvement.

2024 – 2025

Validation partnerships

Preclinical Phase II with Indiana University School of Medicine; clinical planning with the Gregory W. Fulton ALS Clinic at Barrow Neurological Institute; IRB ethics consultation underway.

2025 – 2026

Toward human trials

Expanded ALS dosing & safety study, IRB submission, and first-in-human planning targeting 30–40 patients at partner clinics, with early FDA engagement.

2027+

Future horizon

Peer-reviewed publication, expanded indication (Alzheimer’s Disease), and a global regulatory roadmap across the FDA, EMA, and PMDA.

Milestone 01 Complete

Complete Phase II preclinical studies

Milestone 02 Q4 2026

IRB trial site activation

Milestone 03 Early 2027

First-in-human dosing

Milestone 04 2027+

Expanded indications (MS, PD)

Backed by Institutions

Built with research and clinical partners that matter.

Clinical Research Partner

At the Barrow Neurological Institute — among the top ALS clinics globally — partnering on first-in-human trial planning.