Valion Bio, Inc.

What they do

Valion Bio (formerly Tivic Health Systems) is focused on advancing Entolimod, a recombinant TLR5 agonist, through regulatory approval for Acute Radiation Syndrome (ARS) under the FDA's Animal Rule, and expanding into oncology indications. The company also owns Velocity Bioworks, a contract development and manufacturing organization (CDMO) in San Antonio, Texas. Legacy consumer bioelectronics and prescription bioelectronic device operations were discontinued or divested in 2025.

Revenue drivers

• Entolimod / Entolasta licensing — Worldwide exclusive license from Statera Biopharma; no product revenue yet; potential government procurement and stockpiling.
• Velocity Bioworks CDMO — Wholly owned subsidiary providing contract manufacturing for internal pipeline and third-party customers; revenue potential from Phase I/II biologics market.
• Legacy ClearUP device (discontinued) — Ceased sales at end of 2025; contributed $70,000–$146,000 quarterly revenue in 2025 before wind-down.

Recent performance

For the first quarter of 2026, the company reported revenue of $70,000 (March 2025 quarter) and $86,000 (June 2025 quarter) as it wound down legacy operations. Full-year 2025 net income was -$8.9M, with operating cash flow of -$7.0M. As of June 30, 2026, the company had $2.1M cash, total assets of $32.5M, and shareholder equity of $4.2M. The company has not yet generated product revenue from Entolimod or the CDMO.

Strategy

Management is prioritizing regulatory approval of Entolimod for ARS, with engagement with BARDA, NIAID, and the Department of War for potential procurement and stockpiling. The company is also advancing Entolasta, a next-generation TLR5 agonist, for oncology supportive care and other indications. Integration of Velocity Bioworks is a key focus, with both internal manufacturing support and third-party CDMO business development. The company ceased legacy device operations to concentrate resources on the TLR5 platform.

Risks

• Going concern risk — The 10-K risk factors state that cash and financial resources may be insufficient for the next twelve months, raising substantial doubt about the company's ability to continue as a going concern.
• Regulatory approval uncertainty — Entolimod requires FDA approval under the Animal Rule, which is a non-standard pathway with uncertain requirements and timelines.
• Dependence on government funding — The path to revenue relies heavily on federal agency engagement and potential procurement; no contracts or funding are secured.
• Limited operating history and execution risk — The company has a limited operating history in biopharma, having transformed from a device company, and may fail to execute its business strategy.

Outlook

Management expects continued advancement of the Entolimod platform, including broader government engagement and potential federal funding for future testing. The company aims to leverage the 200-fold manufacturing scale-up and Fast Track/Orphan designations to progress toward BLA submission. Velocity Bioworks is expected to support both internal and third-party manufacturing opportunities, though no revenue milestones are disclosed.