Valion Bio, Inc.

As previously disclosed in that Current Report on Form 8-K (the “Prior 8-K”) filed by Valion Bio, Inc. (formerly known as Tivic Health Systems, Inc.) (the “Company”) with the Securities and Exchange Commission (the “Commission”) on February 12, 2025, on February 11, 2025, the Company entered an exclusive license agreement (the “Original License Agreement”) with Statera Biopharma, Inc. (“Statera”) whereby the Company acquired (i) an exclusive worldwide license to the proprietary Toll-like Receptor 5 (“TLR5”) agonist program of Statera known as Entolimod as it relates to the Acute Radiation Syndrome (“ARS”) indication (the “Initial Indication”) and (ii) an exclusive option (the “Exclusive Option”) to acquire the exclusive worldwide license to additional indications, including Lymphocyte Exhaustion, Immunosenescence, Neutropenia and/or Vaccine Adjuvant and to the TLR5 agonist program of Statera known as Entolasta (the “Subsequent Indications”), in each case as more particularly described in the Prior 8-K. The Original License Agreement transaction was consummated concurrently therewith on February 11, 2025 (the “Closing”).

As previously disclosed in that Current Report on Form 8-K (the “A&R 8-K”) filed by the Company with the Commission on June 25, 2025, on June 18, 2025, the Company entered into an Amended and Restated Exclusive License Agreement (the “A&R License Agreement”), which superseded the Original License Agreement in all respects. The terms and conditions of the A&R License Agreement are substantially similar to those included in the Original License Agreement (as described in the Prior 8-K), with the exception of the following material changes: (i) the payment of royalties pursuant to the A&R License Agreement, if any, may be made by the Company in either cash or securities of the Company, at the discretion of the Company; and (ii) other than the original license fee paid by the Company to Statera in connection with the Closing, all subsequent payments due to Statera under the A&R License Agreement, up to an amount equal to an aggregate of up to $5.6 million, shall be paid by the Company directly to Avenue Capital on behalf of Statera.

The A&R License Agreement obligates the Company to develop and commercialize the licensed products, at its own cost and expense, inclusive of licensed products with respect to any Subsequent Indications obtained upon exercise of an Exclusive Option. In the development and commercialization process, the Company is obligated to meet certain milestones and is obligated to pay certain milestone payments upon accomplishing each milestone. The Company remains liable for certain milestone payments upon accomplishing each milestone related to the ARS indication (as described in the Prior 8-K), certain royalty payments on net sales for ARS as monotherapy, and, if it exercises the Exclusive Option, net sales for all Subsequent Indications, within certain royalty periods; provided that the royalty payment obligations are subject to adjustment in the event that the Company exercises its right under the License Agreement to purchase all right, title and interest in and to all technology licensed or otherwise subject to the Exclusive Option under the License Agreement.

In the development and commercialization process, the Company is obligated to meet certain milestones, and the Company will become obligated to make certain milestone payments, payable in either the form of cash or Company stock (at the Company’s sole discretion), upon accomplishing each milestone. The milestones and related payment obligations applicable to the development and commercialization process are as follows:

Upon exercise of an Exclusive Option with respect to one or more Subsequent Indications, the Company will become obligated to make certain other milestone payments, payable in either the form of cash or Company stock (at the Company’s sole discretion), upon achievement of specific milestones with respect to such Subsequent Indication(s). The milestones and related payment obligations applicable to Neutropenia are as follows:

Pursuant to the License Agreement, in the event that the Company exercises its Exclusive Option with respect to one or more Subsequent Indications, the Company may elect, in its sole discretion, to accelerate any of the milestone payments in advance of the milestone achievements.

Item 1.01 Entry into a Material Definitive Agreement.