Valion Bio (VIBO) Registration filing summary

Company overview and business model

• Late-stage biopharma strategy centers on Entolimod, a recombinant TLR5 agonist being developed for acute radiation syndrome (ARS), ARS subsyndromes and oncology support indications.

• FY2025 pivoted from diversified bioelectronic medical devices to biopharma; consumer healthtech was exited and prescription bioelectronic development suspended to focus resources on the TLR5 franchise.

• Exclusive worldwide license rights and options to Entolimod and second-generation Entolasta were secured in Feb 2025; the immediate priority is manufacturing-process validation for a BLA submission.

• Velocity Bioworks launched as a wholly owned CDMO subsidiary in Dec 2025, intended to support internal manufacturing and validation and generate revenue from third-party biomanufacturing, analytics and cGMP services.

• Entolimod assets have been evaluated in over 40 clinical and preclinical trials, supported by $140M in prior capital, including $35.6M in non-dilutive funding from DoD, DTRA, NASA and NIH.

Use of proceeds and capital allocation

• 3i receives all proceeds from any registered resales; no resale proceeds go to the issuer. Any warrant exercise proceeds would go to the issuer.

• Proceeds from the preferred financings and any warrant exercises are intended for general corporate purposes, including operating expenses, capital expenditures and working capital; management has broad discretion.

• Under the Aug 2026 Second Side Letter, $7.737M consideration included $6.137M retained for overdue Series C cash true-ups, $100,000 for 3i legal fees and $1.5M wired to the issuer.

• The issuer bears registration and prospectus costs; the selling stockholder bears commissions, discounts and other selling expenses.

Risk factors and disclosures

• The auditor’s report on FY2025 and FY2024 financial statements includes an explanatory paragraph describing conditions that raise substantial doubt about the ability to continue as a going concern.

• Resale or conversion/exercise of up to 3,954,381 registered shares could substantially dilute existing holders, pressure the share price and limit future equity financing flexibility.

• Series B and C preferred stock carry cumulative 10% and 6% annual dividends, respectively; both rank senior to common stock, with Series C senior to Series B.

• Risks include financing needs, cash runway and going-concern ability, clinical and regulatory outcomes, manufacturing validation, Nasdaq listing compliance and future product-development execution.

• Future equity or equity-linked financings may cause further dilution; management has broad discretion over any warrant proceeds, which may be invested without a favorable return.