Valion Bio, Inc.

Valion Bio, Inc. is a U.S.-based biomedical company developing recombinant biologic and bioelectronic therapies, with a core focus on its TLR5 program and the Entolimod™ family of candidates. The company also operates Velocity Bioworks, a San Antonio, Texas CDMO platform that supports biomanufacturing and related development services.

20.13

20.13

— Valion Bio, Inc.
%
Biologic therapeutics0% Recombinant biologic candidates centered on the TLR5 platform, including Entolimod and Entolasta.
Bioelectronic therapies0% Product candidates derived from vagus nerve stimulation research and development.
Consumer medical devices100% ClearUP and related accessories sold through direct and reseller channels.
Contract development and manufacturing0% Full-service CDMO activities provided through Velocity Bioworks in San Antonio.

Valion serves two very different customer bases: consumers and channel partners for ClearUP, and future patients,...

  • Consumer health buyersprimary

    Individuals purchasing ClearUP directly or through online retail channels for personal use.

  • Medical resellers and distributorsprimary

    Channel partners such as Simply Medical, Cardinal Health, and other resellers that stock and distribute ClearUP.

  • Biopharma CDMO clientssecondary

    External customers that may use Velocity Bioworks for specialized biomanufacturing and development services.

  • Clinical and institutional end usersemerging

    Hospitals, physicians, and other institutional buyers that could use future Entolimod or Entolasta therapies.

Valion is headquartered in the United States and conducts its consumer and development activities primarily from U.S...

  • •Headquartered in the United States
  • •San Antonio, Texas is a key operating and manufacturing site
  • •ClearUP is sold through U.S. online and retail channels
  • •Therapeutic development is centered on U.S. regulatory pathways
  • •Future commercialization could expand beyond the U.S.

Valion’s strategy is to shift from consumer device monetization toward biologic and bioelectronic drug development with...

01
Advance the TLR5/Entolimod pipelinemedium-term

Clinical progress is the main path to durable value creation beyond the legacy consumer device business.

02
Integrate manufacturing through Velocity Bioworksshort-term

Direct control of biomanufacturing can improve execution, supply reliability, and commercialization readiness.

03
Build third-party CDMO revenuemedium-term

External manufacturing services can diversify revenue while the therapeutic pipeline matures.

04
Exit or monetize ClearUPshort-term

The consumer device business is being wound down, so monetization or divestiture can free capital for the pipeline.

Valion faces development-stage biotech risk, including clinical failure, regulatory delay, and manufacturing scale-up...

critical

Financing risk

The company has relied on equity and other financing and may need more capital before product revenue scales.

Scope
Operating runway and trial funding
Materiality
high
high

Clinical development failure

Entolimod, Entolasta, and bioelectronic candidates may not demonstrate safety or efficacy in trials.

Scope
Pipeline value and future commercialization
Materiality
high
high

Regulatory delay or rejection

Therapeutic candidates require FDA review, and timelines can shift materially with data or filing issues.

Scope
ARS, oncology, and neutropenia programs
Materiality
high
medium

Consumer business wind-down

Exiting ClearUP can reduce near-term revenue and create transition risk in channel inventory sell-through.

Scope
Legacy consumer sales
Materiality
medium
medium

Manufacturing and CDMO execution

Biomanufacturing requires strict quality systems, regulatory compliance, and reliable customer delivery.

Scope
Velocity Bioworks operations
Materiality
medium
Inventory reserves
Affects cost of sales and gross margin
Sales return reserves
Affects reported net revenue
Stock-based compensation
Affects operating expenses and loss measures
Going-concern and liquidity estimates
Affects financial statement presentation and risk disclosure

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: 16.6.2026