PIPELINE
One molecule. A disciplined sequence.
Every expansion earned by data.
The first wedge is chosen for interpretability, not market size. CSA-AKI produces clean proof. That proof earns the franchise.
MARY1
Cardiac Surgery-Associated AKI
Lead program · Core proof of concept
Predictable injury window, risk-enriched KDIGO 2–3 cohort, serial PK/PD sampling, and utilization-linked endpoints now accountable under CMS TEAM. Both prophylactic and treatment dosing strategies are supported by preclinical data — a flexibility no prior CSA-AKI program has had.
Preclinical ✓
IND-enabling
Phase 1
Ph 1b/2a
MARY1
Kidney Transplant — Delayed Graft Function
First data-contingent follow-on
DGF occurs in 20–40% of deceased donor kidney transplant recipients. A second time-anchored IRI setting where exposure–PD–recovery coherence from CSA-AKI can be replicated. Activated only after Gate 3 clears.
IND
Phase 1
Ph 1b/2a
Contingent on CSA-AKI PoC
MARY1
AKI→CVD Prevention
First data-contingent follow-on
Day 30 preclinical antifibrotic signature supports the biological rationale. Pursued only after recovery and durability signals in the acute settings justify expansion.
Phase I
Phase 2
Phase 3
Contingent on CSA-AKI PoC
FINANCING ASK
$46–83M Seed / Series A over 36 months
IND → First-in-Human exposure and renal PD → interim CSA-AKI Proof of Concept. DGF is the first data-contingent follow on if CSA-AKI gates clear. Capital deployment is tranche-gated to milestone achievement.
Full development plan and capital deployment details
The diligence package includes gate definitions, workstream breakdown, and vendor execution plan.