Commercial Litigation RiskActive litigation over U.S. distribution creates material, durable uncertainty for launch timing and go-to-market control. Potential remedies (rescission, injunctions, repayment of $50M) could delay commercialization, force alternative rollout strategies, and increase execution risk over several months.
Weak Cash Generation & Persistent LossesPersistent operating losses, negative operating and free cash flow, and recent zero reported revenue mean the company remains funding-intensive. Even with runway into 2027, rising opex and limited self-funding elevate the risk of dilution or non-dilutive monetization needs within a multi-quarter horizon.
Reimbursement & Ultra‑Cold Labeling ConstraintsUltra-cold supply constraints plus unresolved ASP/AMP transfer‑pricing create structural access and reimbursement barriers. These issues can prevent dose stockpiling, complicate hospital logistics, and materially limit uptake and revenue realization even if approved, lasting through initial commercialization phases.