Pipeline & Market

Three pillars. Three execution pathways.

Parallel development with indication-specific collaborators, on one shared engineering and CMC backbone.

Stage

Where each program stands today.

Program Pillar Design Stage
Radiation injury · UHRP-Bridge Off-the-shelf Permanent invisibility · Temporary graft Preclinical · Lead
SCD & β-thalassemia Off-the-shelf Permanent invisibility · Durable graft Preclinical
SCID & selected IEIs Off-the-shelf Developmental invisibility · Durable graft Preclinical
Transplant tolerance Autologous Molecular mixed chimerism Platform direction
Autoimmune disease Autologous Lineage-directed immunoregulation Exploratory
ECEP Bedside engineering Closed, automated point-of-care manufacturing Enabling tech · In development

All three off-the-shelf indications are preclinical. ECEP is an enabling manufacturing technology for future use and is not required for the lead program's first IND-enabling path.

Near-term milestones

An 18–24 month plan to the next value inflection.

Moving from platform architecture to disease-relevant in vivo validation and one prioritized IND-enabling path.

0–6 mo
Validate lead immune-engineering constructs in primary CD34+ HSPCs
Translates the architecture into the therapeutic cell source
6–12 mo
Demonstrate HLA control, NK protection and developmental switching
Defines the core immune-visibility mechanism
6–18 mo
Complete radiation-injury efficacy studies with AFRRI / HJF
Fastest in vivo platform proof and countermeasure wedge
12–18 mo
Generate SCID multilineage immune-reconstitution proof-of-concept
Validates developmental invisibility in a transplant-relevant setting
12–24 mo
Show hemoglobinopathy donor-chimerism and erythroid-output proof-of-concept
Supports the largest long-term curative-access market
18–24 mo
Select lead product architecture and define the IND-enabling plan
Creates a clear strategic-partnering inflection
Non-dilutive funding

Grant applications supporting the platform.

Hemavive is pursuing federal, state and foundation funding alongside private capital. Status below is current as of this page; no application listed here has been awarded.

Application Supports Status
SBIR Radiation injury · UHRP-Bridge Submitted · Under review
TEDCO Equitech Growth Fund ECEP · bedside engineering Submitted · Under review
Breakthrough T1D HSPC immune-engineering platform Reviewed · Under further assessment
SBIR Hemoglobinopathies · SCID & selected IEIs Submission planned · January
NIH R61 / R33 Selected programs across the platform In preparation
Market & revenue model

Three programs. Three markets. Multiple paths to revenue.

A diversified model across government preparedness, rare-disease transplantation, and global hemoglobinopathy access.

Radiation injury
Initial buyer
U.S. government / DoD / preparedness agencies
Commercial model
Stockpile procurement + replenishment
Initial wedge
HJF / AFRRI → DoD / BARDA path
SCID / selected IEI
Initial buyer
Payers, national health systems, transplant centres
Commercial model
Per-patient curative therapy
Initial wedge
Children's National → U.S. pediatric centres
Hemoglobinopathies
Initial buyer
Payers and national health systems
Commercial model
Per-patient curative therapy
Initial wedge
Middle East–first, then global markets

The radiation opportunity is a government preparedness market, not a patient-count TAM. The hemoglobinopathy opportunity reflects prevalence and long-term access, not a near-term treated-patient count. Sources: Sidra Medicine, BARDA / ASPR, SCID newborn-screening literature, WHO / CDC / TIF.

Positioning

Off-the-shelf access, without one fixed immune state for every disease.

Hemavive does not recreate an HSC — it engineers the clinically proven one, and tunes immune visibility to the biology of each indication.

Autologous cells

Low rejection risk, but available only after single-patient manufacturing — one slow lot per patient.

Matched allogeneic donor

Depends on finding a matched donor; conventional manufacturing, with GVHD and rejection risk.

Fixed-state hypoimmune platforms

Off-the-shelf and scalable, but one fixed immune profile applied to every use case.

Hemavive banked HSPC platform

Off-the-shelf and banked, with immune visibility tuned per disease: permanent, temporary, or developmental.

Investor and partner materials.

Hemavive is engaging with strategic investors, grant partners, engineering partners and scientific collaborators. Financing detail is shared directly.

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