What Aura Biosciences, Inc. told the SEC could break it.

Aura owns no manufacturing and relies on a single source for each of its regulatory starting materials, drug substance and drug product for lead candidate bel-sar, with no qualified backup suppliers — a fragile, concentrated supply chain.

“We are currently reliant on a single source for each of our regulatory starting materials, drug substance and drug product manufacturing for bel-sar.”

Pre-revenue Aura posted a $106.2M net loss in 2025 and a $480.4M accumulated deficit and has disclosed substantial doubt about its ability to continue as a going concern, making it dependent on additional financing.

“Our net losses were $106.2 million and $86.9 million for the years ended December 31, 2025 and 2024, respectively. As of December 31, 2025, we had an accumulated deficit of $480.4 million.”

CMS's proposed GLOBE (Medicare Part B) and GUARD (Part D) models would impose international-benchmark MFN rebates on single-source drugs and sole-source biologics, creating pricing/reimbursement risk for an approved bel-sar (Aura's only product, which also faces FDA-approval risk).

“the Global Benchmark for Efficient Drug Pricing Model, or GLOBE, for Medicare Part B, would require manufacturers of specified single source drugs and sole source biologics to pay incremental rebates based on international benchmark prices, with participation triggered for products meeting CMS's spending and eligibility criteria.”