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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date of Report (Date
of earliest event reported): July 31,
2026
Valion
Bio, Inc.
(Exact name of Registrant as Specified in Its
Charter)
| Delaware |
001-41052 |
81-4016391 |
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| |
|
|
1305 E. Houston Street,
Building 1, Suite 311 |
|
|
| San Antonio, Texas |
|
78205 |
| (Address of Principal Executive Offices) |
|
(Zip Code) |
| Registrant’s Telephone Number, Including Area Code: 888 276-6888 |
(Former Name or Former Address, if Changed
Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
| Common Stock, par value $0.0001 per share |
|
VBIO |
|
The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act.
INTRODUCTORY
NOTE
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:
| Event |
Payment |
| Validation of current inventory of Materials for distribution and sales |
$750,000 |
| Filing of BLA with FDA for Acute Radiation Syndrome |
$1,000,000 |
| Total Acute Radiation Syndrome Development Milestones |
$1,750,000 |
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:
| Event |
Payment |
| File IND and Initiate Phase 2 Clinical Study for Neutropenia |
$500,000 |
| Phase III Completion - successfully meets endpoint required to secure FDA approval for treatment of Neutropenia |
$750,000 |
| File BLA with FDA and achieve FDA Approval for Neutropenia |
$1,500,000 |
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.
Securities Purchase Agreement
On July 31, 2026, the Company
issued an aggregate of 1,287.8685 shares of Series A Preferred Stock (“Milestone Shares”), as consideration for the Milestone
Payment (as discussed in more detail in Item 8.01 below), to Statera and Avenue Venture Opportunities Fund, L.P. (“Avenue”).
On July 31, 2026, in connection
with the Milestone Payment (as discussed in more detail in Item 8.01 below), the Company entered into a Securities Purchase Agreement,
in substantially the same form as the securities purchase agreement attached as Exhibit 10.2 to the Prior 8-K (the “Purchase Agreement”),
with Avenue, pursuant to which the Company issued certain shares of Series A Preferred Stock as partial consideration for the Milestone
Payment.
The Purchase Agreement also provides
certain registration rights related to the securities subject thereto. Specifically, the Company is required to prepare and file a resale
registration statement with the Commission within 60 calendar days following the Closing Date, with respect to the resale of all of the
shares of common stock of the Company underlying the Series A Preferred Stock issued thereunder.
The foregoing
description of the terms of the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the
full text of the Purchase Agreement filed as Exhibit 10.2 to the Prior 8-K, which is incorporated herein by reference.
Item 3.02 Unregistered Sales
of Equity Securities.
The information
contained in Item 1.01 and 8.01 of this Current Report on Form 8-K is incorporated by reference into this Item 3.02.
On July 31, 2026, the
Company issued the Milestone Shares to Statera and Avenue, each of which has prior hereto represented that it was an “accredited
investor,” as defined in Regulation D. Such issuances were exempt from the registration requirements of the Securities Act of 1933,
as amended (the “Securities Act”), in reliance in Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.
Neither the shares of
Series A Preferred Stock or the shares of common stock issuable upon conversion of the Series A Preferred Stock, have been registered
under the Securities Act and none of such shares may be offered or sold in the United States absent registration or an exemption from
registration under the Securities Act and any applicable state securities laws. Accordingly, the shares, constitute, or will constitute
when issued, “restricted securities” within the meaning of Rule 144 under the Securities Act.
The shares of Series A Preferred Stock are subject to certain
limitations of conversion, as further described in the Certificate of Designation of Series A Non-Voting Convertible Preferred Stock,
including that a holder of Series A Preferred Stock is prohibited from converting shares of Series A Preferred Stock into shares of common
stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage
(to be established by the holder between 4.9% and 19.9%) of the total number of shares of common stock issued and outstanding immediately
after giving effect to such conversion.
Item
8.01 Other Events.
As of the
date hereof, the Company has, in connection with the development and commercialization process, achieved its first milestone, relating
to the validation of current inventory of materials for distribution and sales. In connection therewith, the Company is obligated to make
a milestone payment of $750,000 (the “Milestone Payment”), in accordance with the terms of the A&R License Agreement.
The foregoing
description of the Company’s obligations related to the Milestone Payment does not purport to be complete and is qualified in its
entirety by reference to the full text of the A&R License Agreement, a copy of which is filed as Exhibit 10.1 to the A&R 8-K and
is incorporated herein by reference.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
|
|
VALION BIO, INC. |
| |
|
|
|
| Date: |
August 6, 2026 |
By: |
/s/ Melinda Lackey |
| |
|
|
Name: Melinda Lackey
Title: General Counsel and Senior Vice President of Legal Affairs |
