Valion Bio clears first Entolimod milestone, settles $750,000 payment in preferred stock

Valion Bio, Inc., formerly Tivic Health Systems, Inc., filed an 8-K dated July 31, 2026, disclosing that the company has achieved its first milestone in the development and commercialization process, tied to validation of its current inventory of materials for distribution and sales, and is now obligated to make a $750,000 milestone payment under the terms of its Amended and Restated Exclusive License Agreement.¹

The license traces back to a February 11, 2025 deal granting the company an exclusive worldwide license to Statera Biopharma, Inc.'s Toll-like Receptor 5 agonist program known as Entolimod for Acute Radiation Syndrome, along with an option on additional indications including Lymphocyte Exhaustion, Immunosenescence, Neutropenia and Vaccine Adjuvant tied to a related compound called Entolasta.¹ That agreement was later superseded by an amended and restated version signed June 18, 2025, under which royalty payments may be made in cash or company securities at the company's discretion, and most subsequent payments owed to Statera, up to an aggregate of $5.6 million, are payable directly to Avenue Capital on Statera's behalf.¹

To cover the newly triggered payment, on July 31, 2026 the company issued a total of 1,287.8685 shares of Series A Preferred Stock as consideration for the Milestone Payment to Statera and Avenue Venture Opportunities Fund, L.P.¹ The shares carry registration rights, and the company must file a resale registration statement within 60 days of the closing date covering the common stock underlying the preferred shares.¹

Future milestones remain unchanged: a $1,000,000 payment is due upon filing a BLA for Acute Radiation Syndrome, while exercising the Neutropenia option would trigger $500,000 for filing an IND and starting a Phase 2 study, $750,000 for Phase III completion meeting the FDA approval endpoint, and $1,500,000 for BLA filing and FDA approval.¹