Business Context and Reporting Period
This Form 8-K Current Report was filed by Tivic Health Systems, Inc. (not Valion Bio, Inc.) on August 20, 2025. The registrant is a Delaware corporation with principal executive offices in Fremont, California, and its common stock trades on The Nasdaq Stock Market under the symbol TIVC. The filing reports a material event under Item 8.01 regarding the acquisition of regulatory assets.
Key Financial Metrics
The filing text does not provide specific financial data such as revenue, profit, cash flow, margins, debt, or liquidity metrics. This report focuses exclusively on a corporate event rather than periodic financial results.
Material Changes
On August 20, 2025, the Company completed the transfer from Statera Biopharma, Inc. of two investigational new drug applications (INDs) for its lead candidate, Entolimod. The transferred INDs cover:
- Treatment of acute radiation syndrome (ARS), including hematopoietic (ARS-H) and gastrointestinal (ARS-GI) sub-syndromes.
- Treatment of advanced cancers, including use as an anti-tumor agent and for mitigating effects of cancer treatments.
Guidance, Outlook, and Risks
The filing contains forward-looking statements regarding the Company's future performance and achievements based on management's current estimates. These statements are subject to substantial risks and uncertainties, including those detailed in other SEC filings, which could cause actual results to differ materially. No specific financial guidance or quantitative outlook was provided in this document.
Investor Verification Checklist
- Verify the exact scope and regulatory status of the two transferred INDs for Entolimod.
- Confirm the terms of the transfer agreement with Statera Biopharma, Inc., including any financial consideration or ongoing obligations.
- Review the full text of the press release filed as Exhibit 99.1 for additional details on the clinical development plan.
- Check subsequent filings for updates on the Company's cash position and runway, as this 8-K does not disclose liquidity.