Development Pipeline

POP02: From Science
to Clinic

POP02 has completed preclinical development. IND submission is targeted upon completion of IQ toxicology. Phase I in DMG/DIPG is the next milestone.

Pipeline

Clinical Development

Asset Indication Preclinical IND Phase I Phase II
POP02 Triple-action oncolytic adenovirus
Lead 		DMG / DIPG
Pediatric
POP02 Platform expansion Glioblastoma
Adult
POP02 Platform expansion High risk solid tumors
Pediatric / Adult
POPCAR03 DMG / DIPG
Pediatric
Regulatory Strategy

Accelerated Pathways to Approval

✦
Orphan Drug Designation

Available in both US (FDA) and EU (EMA). Provides 10-year market exclusivity, fee waivers, and priority review. Pediatric rare disease further strengthens eligibility.

✦
Breakthrough Therapy / PRIME

POP02's triple mechanism and significant unmet need in DMG support Breakthrough Therapy (FDA) and PRIME (EMA) designation applications after Phase I proof-of-concept.

✦
Pediatric Incentives

Best Pharmaceuticals for Children Act (BPCA) and EU Paediatric Regulation provide 6-month exclusivity extension and fee waivers for pediatric-specific development. POP02 qualifies under both frameworks.

Platform Expansion

Beyond DMG:
The GBM Opportunity

POP02's modular sdAb payload can be reloaded against different targets with minimal re-engineering. GBM is the natural expansion: same CNS context, established DNX2401 adult data, and a projected $4.8B market by 2030.

PET brain scans showing metabolic activity across 12 tumor slices
300,000
New GBM Cases / Year
New Glioblastoma cases diagnosed globally per year — the largest adult malignant brain tumor population.
15 months
GBM Median Survival
Median survival with current standard of care — unchanged in decades despite significant R&D investment.
$4.8B →
Projected Market by 2030
Projected GBM therapeutics market by 2030, driven by demand for effective disease-modifying therapies.
See Platform Architecture
Next Steps

Ready to Advance
POP02 to the Clinic

IND submission is the next milestone. We are raising to fund IQ toxicology completion and Phase I initiation. If you want to be part of what happens next, let's talk.

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