Form 8-K

8-K — Valion Bio, Inc.

Accession: 0001683168-26-006848

Filed: 2026-09-01

Period: 2026-08-27

CIK: 0001787740

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Entry into a Material Definitive Agreement

Item: Unregistered Sales of Equity Securities

Item: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — valion_8k.htm (Primary)

EX-10.1 — LETTER AGREEMENT WITH 3I, LP DATED 8-27-26 (valion_ex1001.htm)

EX-99.1 — PRESS RELEASE DATED 8-31-26 (valion_ex9901.htm)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K — FORM 8-K

8-K (Primary)

Filename: valion_8k.htm · Sequence: 1

Tivic Health Systems, Inc. Form 8-K

false

0001787740

2026-08-27

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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): August 27,

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

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. ☐

Item 1.01 Entry into a Material Definitive

Agreement.

Valion Bio, Inc., a Delaware corporation (the

“Company”) and 3i, LP (“3i”) are parties to that certain Securities Purchase Agreement, dated as of April 29,

2025 (as assigned and amended as of December 9, 2025, the “Series B Preferred Purchase Agreement”), with respect to the purchase

and sale of (a) up to 8,400 shares of the Company’s Series B Non-Voting Convertible Preferred Stock (“Series B Preferred Shares”)

and (b) warrants (“Series B Warrants”) to purchase a number of shares of common stock, par value $0.0001 per share, of the

Company (the “Common Stock”) at an initial exercise price per share determined pursuant to Section 2.2 of the Series B Preferred

Purchase Agreement, for an aggregate purchase price of up to $8,400,000 in a series of closings.

The Company, 3i and certain other purchasers are

parties to that certain Securities Purchase Agreement, dated as of December 9, 2025 (the “Series C Preferred Purchase Agreement”),

with respect to the purchase and sale of (a) up to 75,000 shares of the Company’s Series C Non-Voting Convertible Preferred Stock

(“Series C Preferred Shares”) and (b) warrants (“Series C Warrants”) to purchase a number of shares of Common

Stock at an initial exercise price per share equal to the Fixed Conversion Price as defined in the Certificate of Designation of Rights

and Preferences of the Series C Preferred Shares (the “Series C Certificate of Designation”), for an aggregate purchase price

of up to $75,000,000 in a series of closings.

On August 31, 2026, the Company and 3i entered

into a letter agreement (the “Letter Agreement”), pursuant to which the Company agreed to issue to 3i (a) 100 Series B Preferred

Shares (the “Closing Series B Shares”), (b) Series B Warrants to purchase 3,077 shares of Common Stock at an initial exercise

price of $3.62 per share (the “Closing Series B Warrants”), (c) 7,637 Series C Preferred Shares (the “Closing Series

C Shares” and, together with the Closing Series B Shares, the “Closing Shares”), and (d) Series C Warrants to purchase

1,053,969 shares of Common Stock for an initial exercise price of $3.62 per share (the “Closing Series C Warrants” and,

together with the Closing Series B Warrants, the “Closing Warrants”), for an aggregate purchase price of $7,737,000, to be

paid on or about August 31, 2026 (the “Closing Purchase Price” and the closing of such purchase and sale, the “Closing”).

The Closing Purchase Price shall consist of (a) $6,137,000 to be retained by 3i to satisfy overdue cash true-up payments pursuant to Section

6(b) of the Series C Certificate of Designation, (b) $100,000 to be retained by 3i to pay the fees of its legal counsel in connection

with the purchase of the Company’s securities by 3i and (c) $1,500,000 to be paid to the Company in immediately available funds

by wire transfer. The number of shares of Common Stock underlying the Closing Warrants and the exercise price thereof give effect to the

Company’s 1-for-25 reverse stock split effective at 12:01 a.m. Eastern Time on August 31, 2026. Such securities were issued under

an exemption from registration pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, and/or Rule 506(b) promulgated thereunder.

The form of the Letter Agreement is attached to this Current Report as Exhibit 10.1.

Pursuant to the Letter Agreement, the Company

also agreed to use its commercially reasonable efforts to (a) file with the Securities and Exchange Commission (the “SEC”),

no later than 30 days from the date of the Closing, a registration statement (the “Registration Statement”) covering the maximum

number of shares of Common Stock issuable upon conversion of the Closing Shares and the shares of Common Stock issuable upon exercise

of the Closing Warrants so as to permit the resale of such securities by 3i, (b) have the Registration Statement declared effective by

the SEC no later than 60 days from the date of the Closing, and (c) keep the Registration Statement effective, including but not limited

to pursuant to Rule 415 promulgated under the Securities Act of 1933, as amended, and available for the resale by 3i of all of the securities

covered thereby at all times until the date on which 3i shall have sold all the securities covered thereby or they cease to require registration

pursuant to the Letter Agreement.

Item 3.02 Unregistered Sales of Equity Securities.

The information contained in Item 1.01 is hereby

incorporated by reference into this Item 3.02.

Item 5.02 Departure of Directors or Certain

Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Appointment of Jared Malbin to the Board

On August 27, 2026, the Company appointed Jared

Malbin as a member of the board of directors (the “Board”), effective immediately.

Mr. Malbin, 47, has more than 25 years of experience

in the financial services industry, spanning broker-dealer operations, compliance, finance and capital markets. Since 2024, Mr. Malbin

has served as Chief Operating Officer of Lucid Capital Markets, LLC, a boutique investment banking broker-dealer, where he oversees firm

operations and regulatory strategy across the firm’s capital markets and trading businesses. Prior to that, from 2019 to 2024, Mr.

Malbin served in senior executive and management roles at investment firms. He has extensive experience building regulatory and compliance

functions and guiding firms through regulatory examinations and approval processes. Mr. Malbin also serves on the boards of two private

insurance companies. Mr. Malbin holds a Bachelor of Arts degree from Tufts University.

There are no family relationships between Mr. Malbin

and any of the Company’s directors, executive officers or persons nominated or chosen by the Company to become a director or executive

officer. The Company is not aware of any transactions or relationships between Mr. Malbin and the Company that would require disclosure

under Item 404(a) of Regulation S-K under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

Appointment of Thomas Jensen to the Board

On August 27, 2026, the Company appointed Thomas Jensen

as a member of the Board, effective immediately.

Mr. Jensen, 47, has more than 20 years of global biotechnology

and oncology experience spanning research and development, corporate strategy and business leadership. Since December 2023, Mr. Jensen

has served as Chief Executive Officer of Allarity Therapeutics, Inc. (Nasdaq: ALLR) (“Allarity”), a clinical-stage pharmaceutical

company, where he oversees the advancement of stenoparib, a dual PARP/WNT inhibitor, through Phase 2 trials in advanced ovarian cancer.

Prior to that, Mr. Jensen served as Chief Technology Officer and Head of IT/Investor Relations at Allarity from August 2021 to December

2023. Mr. Jensen currently serves as a director of Allarity and previously served as a director of a Swedish publicly traded investment

company. Mr. Jensen holds a Bachelor of Science degree in Biology from the Technical University of Denmark and conducted further studies

in Biology at the University of Copenhagen.

There are no family relationships between Mr. Jensen

and any of the Company’s directors, executive officers or persons nominated or chosen by the Company to become a director or executive

officer. The Company is not aware of any transactions or relationships between Mr. Jensen and the Company that would require disclosure

under Item 404(a) of Regulation S-K under the Exchange Act.

Item 7.01 Regulation FD Disclosure.

On September 1, 2026, the Company issued a press

release announcing the changes to the Board discussed in Item 5.02 above. A copy of that press release is furnished as Exhibit 99.1 of

this Current Report and incorporated herein by reference.

The information set forth under Item 7.01 of this

Current Report, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of

Section 18 of the Exchange Act, or otherwise subject to the liabilities of such section. The information in Item 7.01 of this Current

Report, including Exhibit 99.1, shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or

the Exchange Act, regardless of any incorporation by reference language in any such filing, except as expressly set forth by specific

reference in such a filing. This Current Report will not be deemed an admission as to the materiality of any information in this Current

Report that is required to be disclosed solely by Regulation FD.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

No.

Description

10.1

Letter Agreement between the Company and 3i, LP, dated August 31, 2026.

99.1

Press Release, dated September 1, 2026.

104

Cover Page Interactive

Data File (formatted in iXBRL, and included in exhibit 101)

Forward-Looking Statements

This Current Report contains certain forward-looking

statements that involve substantial risks and uncertainties. When used herein, the terms “anticipates,” “expects,”

“estimates,” “believes,” “will” and similar expressions, as they relate to us or our management, are

intended to identify such forward-looking statements.

Forward-looking statements in this Current Report

or hereafter, including in other publicly available documents filed with the Commission, reports to the stockholders of the Company and

other publicly available statements issued or released by us involve known and unknown risks, uncertainties and other factors which could

cause our actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial

or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management’s

best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the

risks set forth herein and in such other documents filed with the Commission, each of which could adversely affect our business and the

accuracy of the forward-looking statements contained herein. Our actual results, performance or achievements may differ materially from

those expressed or implied by such forward-looking statements.

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:

September 1, 2026

By:

/s/ Melinda Lackey

Name: Melinda Lackey

Title: General Counsel and Senior Vice President of Legal Affairs

EX-10.1 — LETTER AGREEMENT WITH 3I, LP DATED 8-27-26

EX-10.1

Filename: valion_ex1001.htm · Sequence: 2

Exhibit 10.1

August 31, 2026

3i, LP

2 Wooster Street, 2nd Floor

New York, NY 10013

Attention: Maier J. Tarlow

Re: Side Letter — Closing under Series B Preferred Purchase Agreement and Series C Preferred Purchase

Agreement

Dear Mr. Tarlow:

This letter agreement (this “Letter

Agreement”) is entered into as of the date first written above, by and between Valion Bio, Inc., a Delaware corporation (the “Company”),

and 3i, LP, a Delaware limited partnership (the “Purchaser”).

The Company and the Purchaser

are party to that certain Securities Purchase Agreement, dated April 29, 2025 (as assigned and amended as of December 9, 2025, the “Series

B Preferred Purchase Agreement”), with respect to the purchase and sale of up to 8,400 shares of the Company’s Series B Non-Voting

Convertible Preferred Stock (“Series B Preferred Shares”) and warrants (“Series B Warrants”) to purchase a number

of shares of common stock, par value $0.0001 per share, of the Company (the “Common Stock”) at an initial exercise price determined

pursuant to Section 2.2 of the Series B Preferred Purchase Agreement, for an aggregate purchase price of up to $8,400,000 in a series

of closings. As of the date hereof, the Purchaser has the option, but not the obligation, to purchase up to 1,750 Series B Preferred Shares

and corresponding Series B Warrants for up to $1,750,000.

The Company, the Purchaser

and certain other purchasers are party to that certain Securities Purchase Agreement, dated as of December 9, 2025 (the “Series

C Preferred Purchase Agreement”), with respect to the purchase and sale of (a) up to 75,000 shares of the Company’s Series

C Non-Voting Convertible Preferred Stock (“Series C Preferred Shares”) and (b) warrants (“Series C Warrants”)

to purchase a number of shares of Common Stock calculated pursuant to Section 2.2 of the Series C Preferred Purchase Agreement at an initial

exercise price per share equal to the Fixed Conversion Price as defined in the Certificate of Designation of Rights and Preferences of

the Series C Preferred Shares (the “Series C Certificate of Designation”), for an aggregate purchase price of up to $75,000,000

in a series of closings. As of the date hereof, the Purchaser has purchased 6,000 Series C Preferred Shares and corresponding Series C

Warrants for an aggregate purchase price of $6,000,000, and has the right, subject to the terms and conditions set forth in the Series

C Preferred Purchase Agreement, to purchase up to an additional 31,500 Series C Preferred Shares and corresponding Series C Warrants for

an aggregate purchase price of up to $31,500,000.

Capitalized terms not defined

herein shall have the meanings assigned thereto in the Series C Preferred Purchase Agreement.

The Company and the Purchaser

hereby agree as follows:

1. Closing. The Purchaser

agrees, upon the satisfaction of the conditions set forth in Section 2, to purchase from the Company, and the Company agrees to issue

to the Purchaser, in a closing (the “Closing”), (a) 100 Series B Preferred Shares (the “Closing Series B Shares”),

(b) Series B Warrants to purchase 3,077 shares of Common Stock an initial exercise price of $3.62 per share (the “Closing Series

B Warrants”), (c) 7,637 Series C Preferred Shares (the “Closing Series C Shares” and, together with the Closing Series

B Shares, the “Closing Shares”), and (d) Series C Warrants to purchase 1,053,969 shares of Common Stock for an initial exercise

price of $3.62 per share (the “Closing Series C Warrants” and, together with Closing Series B Warrants, the “Closing

Warrants”), for an aggregate purchase price of $7,737,000, to be paid on or about August 31, 2026 (the “Closing Purchase Price”),

subject to the satisfaction of each of the conditions set forth in Section 2. The Closing Purchase Price shall consist of (a) $6,137,000

to be retained by the Purchaser to satisfy overdue cash true-up payments pursuant to Section 6(b) of the Series C Certificate of Designation,

(b) $100,000 to be retained by the Purchaser to pay the fees of its legal counsel in connection with the purchase of the Company’s

securities by the Purchaser and (c) $1,500,000 to be paid to the Company in immediately available funds by wire transfer. The number of

shares of Common Stock underlying the Closing Warrants and the exercise price thereof give effect to the Company’s 1-for-25 reverse

stock split effective at 12:01 a.m. Eastern Time on August 31, 2026.

2. Closing Conditions.

The obligations of the Purchaser hereunder in connection with the Closing are subject to each of the following conditions being satisfied

or waived by the Purchaser prior to or at the Closing:

(a) Each of the conditions set

forth in Sections 2.3(b) and 2.3(h) of the Series B Preferred Purchase Agreement shall have been satisfied or waived by the Purchaser.

(b) Each of the conditions set

forth in Sections 2.3(b) and 2.3(d) of the Series C Preferred Purchase Agreement shall have been satisfied or waived by the Purchaser.

the Series B Closing Shares and the Series B Closing Warrants.

(d) The Purchaser shall have received

the Series C Closing Shares and the Series C Closing Warrants.

(e) The Purchaser shall have received

each of the deliverables set forth in Section 2.3(l) of the Series B Preferred Purchase Agreement.

(f) The Purchaser shall have received

each of the deliverables set forth in Section 2.3(j) of the Series C Preferred Purchase Agreement.

(g) The Purchaser shall have received

appropriate notices from the Company, reasonably satisfactory to the Purchaser, relating to price adjustments in accordance with the terms

of the Company’s securities held by the Purchaser after giving effect to the Closing.

(h) The Common Stock is listed

on the Nasdaq Capital Market (“Nasdaq”) and the Company is in continued compliance with all of the listing and maintenance

requirements of Nasdaq. The Company continues to have no reason to believe that it is not, or with the passage of time will not, be able

to comply with its continued listing requirements to remain on Nasdaq.

3. Registration Rights.

The Company hereby agrees to use its commercially reasonable efforts to (a) file with the Securities and Exchange Commission (the “SEC”),

no later than 30 days from the date of the Closing, a registration statement (the “Registration Statement”) covering the maximum

number of shares of Common Stock issuable upon conversion of the Closing Shares and the shares of Common Stock issuable upon exercise

of the Closing Warrants so as to permit the resale of such securities by the Purchaser, (b) have the Registration Statement declared effective

by the SEC no later than 60 days from the date of the Closing, and (c) keep the Registration Statement effective, including but not limited

to pursuant to Rule 415 promulgated under the Securities Act of 1933, as amended, and available for the resale by the Purchaser of all

of the securities covered thereby at all times until the date on which the Purchaser shall have sold all the securities covered thereby

or they cease to require registration pursuant to this paragraph.

4. Counterparts; Electronic

Signatures. This Letter Agreement may be executed in one or more counterparts, each of which shall be deemed an original and all of

which, taken together, shall constitute one and the same instrument. Signatures transmitted by electronic means (including DocuSign or

similar electronic signature platforms) shall be deemed original signatures for all purposes.

5. Governing Law. This

Letter Agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to its conflict

of laws principles.

[Signature Page to Follow]

[Signature Page to Side Letter]

Please confirm the Purchaser’s

agreement to the foregoing by executing this Letter Agreement in the space provided below.

Very truly yours,

Valion Bio, Inc.

By:

/s/ Lisa Wolf

Name:

Lisa Wolf

Title:

Chief Operating Officer

AGREED AND ACCEPTED:

3i, LP

By:

3i Management LLC, its General Partner

By:

/s/ Maier J. Tarlow

Name:

Maier J. Tarlow

Title:

Manager

EX-99.1 — PRESS RELEASE DATED 8-31-26

EX-99.1

Filename: valion_ex9901.htm · Sequence: 3

Exhibit 99.1

FOR IMMEDIATE RELEASE

Valion Bio Announces Changes to Management

and Board of Directors

Current CFO, Lisa Wolf named President and

COO, assuming expanded executive and operational leadership. Jared Malbin and Thomas Jensen appointed as directors.

· Lead Asset Positioned for Significant Markets:

Entolimod targets the projected $7.8 billion Acute Radiation Syndrome (“ARS”) market by 2032 and a multi-billion-dollar oncology

supportive-care opportunity through its differentiated dual-tissue cytoprotection platform¹˒²

· Focused on Value Creation: Streamlined

leadership and additional Board expertise are designed to accelerate execution, strengthen commercial opportunities and better align Valion’s

market valuation with the underlying value of its assets, capabilities, and future prospects

SAN ANTONIO, TX

/ September 1, 2026 / -- Valion Bio, Inc. (Nasdaq: VBIO) (“Valion” or the “Company”), a clinical-stage

biopharmaceutical company, today announced strategic changes to its management team and Board of Directors designed to accelerate

execution across its clinical and commercial initiatives and position the Company for its next phase of growth.

The Company’s Board

of Directors has unanimously appointed Lisa Wolf to the expanded roles of President and Chief Operating Officer (“COO”), effective

immediately. Ms. Wolf will continue to serve as Chief Financial Officer (“CFO”) and will assume executive leadership of the

Company following the departure of former Chief Executive Officer, Michael K. Handley.

The expanded role brings

Valion’s financial, operational and strategic functions under unified leadership at an important inflection point for the Company.

Ms. Wolf will oversee the continued advancement of Valion’s lead product candidate, Entolimod, while directing the Company’s

efforts to expand government, international and commercial partnership opportunities.

“Lisa has earned

the deep respect and confidence of the Board, and she is uniquely qualified to lead Valion through this next phase of execution and growth,”

said Sheryle Bolton, Chair of Valion’s Board of Directors. “Valion has built a differentiated combination of proprietary science,

biomanufacturing infrastructure and significant market opportunities. Our priority now is execution — advancing Entolimod, pursuing

commercial and government opportunities, and creating a business model capable of generating sustainable value for shareholders.”

“I am energized

to assume expanded leadership of Valion at this pivotal stage in the Company’s development,” Ms. Wolf said. “Our objective

is clear: translate the potential of Entolimod and our manufacturing platform into meaningful commercial opportunities while maintaining

disciplined capital allocation and execution.

Entolimod has the potential

to address significant unmet needs across both ARS and oncology supportive care. Its differentiated approach to cytoprotection provides

a compelling foundation for pursuing government, institutional and pharmaceutical opportunities.”

Strengthening the

Board for Valion’s Next Phase

The Company also announces

the recent appointments of Thomas Jensen and Jared Malbin as directors to its Board.

Mr. Malbin brings more

than 25 years of financial-services experience spanning broker-dealer operations, compliance, finance and capital markets. He currently

serves as Chief Operating Officer of Lucid Capital Markets, LLC, a boutique investment-banking broker-dealer, where he oversees firm operations

and regulatory strategy across the firm’s capital-markets and trading businesses. He has extensive experience building regulatory

and compliance functions and guiding firms through regulatory examinations and approval processes. Mr. Malbin also serves on the boards

of two private insurance companies. He holds a Bachelor of Arts degree from Tufts University.

Mr. Jensen currently

serves as Chief Executive Officer, Co-Founder and Director of Nasdaq-listed Allarity Therapeutics. Under his leadership, Allarity is advancing

stenoparib, a dual PARP/WNT inhibitor, through Phase 2 trials in advanced ovarian cancer. Mr. Jensen brings more than 20 years of global

biotechnology and oncology experience spanning research and development, corporate strategy and business leadership. He holds a Bachelor

of Science degree in Biology from the Technical University of Denmark and conducted further studies in Biology at the University of Copenhagen.

“We are very pleased

to welcome Jared and Thomas to Valion’s Board,” said Ms. Bolton. “Their combined experience across capital markets,

regulatory strategy, biotechnology, oncology and corporate development significantly strengthens the Board as we enter our next phase.

These appointments also reflect the importance of maintaining strong alignment among Valion, its Board and its shareholders.”

Sources

1 CoherentMI

“Acute Radiation Syndrome Market Size and Share Analysis – Growth Trends and Forecasts” https://www.coherentmi.com/industry-reports/acute-radiation-syndrome-market

2 Market Research.com

“Global Chemotherapy-Induced Neutropenia Treatment Market 2026-2035” https://www.marketresearch.com/Orion-Market-Research-v4261/Global-Chemotherapy-Induced-Neutropenia-Treatment-44733511/

About Valion Bio, Inc.

Valion Bio, Inc. (Nasdaq:

VBIO) is developing biologics that activate innate immune pathways for cytoprotection and modulate immune responses in conditions driven

by radiation, disease and immune dysregulation.

The Company’s lead

candidate, Entolimod, is being developed as a potential medical countermeasure for Acute Radiation Syndrome and has been evaluated in

animal models under the U.S. Food and Drug Administration’s (“FDA”) Animal Rule, which allows the Agency to approve

new drugs and biological products based on animal efficacy studies when human clinical trials are not ethical or feasible, such as in

the case of acute radiation exposure. Entolimod is a novel Toll-like Receptor 5 agonist designed to activate NF-κB signaling pathways

associated with cellular protection, tissue recovery and immune response. The product candidate has received Fast Track and Orphan Drug

designations from the FDA.

Valion Bio is also advancing

Entolasta, a next-generation TLR5 agonist designed for potential use in broader therapeutic applications, including oncology supportive

care. The Company’s pipeline includes potential programs in neutropenia and immune dysfunction.

For more information,

visit www.valionbio.com.

Forward-Looking Statements

This press release

contains forward-looking statements that are subject to substantial risks and uncertainties. All statements other than statements of historical

fact contained in this press release are forward-looking statements.

Forward-looking statements

may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,”

“estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,”

“predict,” “project,” “seek,” “should,” “target,” “will,” “would,”

or similar expressions, although not all forward-looking statements contain these words.

Forward-looking statements

in this press release include, among others, statements regarding: the development and regulatory advancement of Entolimod under the FDA

Animal Rule U.S. or allied-government entities; the timing and outcome of regulatory or government interactions; the potential use of

Entolimod before or after radiation exposure; the product candidate’s potential to address gastrointestinal or hematopoietic radiation

injury; the initiation, design, timing and outcome of physician-sponsored studies in neutropenia; the development and potential applications

of Entolasta; the ability of the Company to expand the TLR5 platform into oncology supportive care or other indications; the scalability,

capacity, economics and strategic benefits of the Company’s manufacturing operations; potential third-party CDMO demand or revenue;

and the Company’s ability to obtain additional capital and execute its business strategy.

These forward-looking

statements are based on Valion Bio’s current expectations, estimates and assumptions and are subject to inherent uncertainties,

risks and assumptions that are difficult to predict. Actual results could differ materially from those expressed or implied by these forward-looking

statements as a result of numerous factors, including the Company’s interactions with and guidance from the FDA and other regulatory

authorities; the continued interest of BARDA and other U.S. government agencies in Entolimod; the outcome of the Company’s engagement

with Ukraine’s Ministry of Health and other allied governments; whether any Request for Information results in a pre-submission

meeting, regulatory authorization, stockpiling agreement, procurement or revenue; the Company’s ability to satisfy the requirements

of the FDA Animal Rule; the timing and success of preclinical and clinical studies; the Company’s ability to achieve expected benefits

from its development and manufacturing assets; changes in relationships with partners, government agencies or other stakeholders; manufacturing,

supply-chain and quality risks; the ability to attract and retain CDMO customers; the Company’s need for and ability to secure additional

working capital; the Company’s ability to maintain its Nasdaq listing; changes in tariffs, inflation, political conditions, legal

requirements, regulatory policy and economic conditions; and other risks described in the Company’s filings with the Securities

and Exchange Commission.

Readers are cautioned

not to place undue reliance on these forward-looking statements. For a discussion of risks and uncertainties relevant to Valion Bio, see

the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, including the section titled “Risk Factors,”

as well as the Company’s subsequent filings with the SEC.

Forward-looking

statements contained in this press release speak only as of the date of this release. Valion Bio undertakes no obligation to update any

forward-looking statement except as required by applicable law.

Investor and Media Contact:

Stephen Kilmer

(646) 274-3580

Stephen.Kilmer@valionbio.com

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Entity File Number

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Entity Registrant Name

Valion

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Entity Central Index Key

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Entity Tax Identification Number

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Entity Incorporation, State or Country Code

Entity Address, Address Line One

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Title of 12(b) Security

Common Stock, par value $0.0001 per share

Trading Symbol

VBIO

Security Exchange Name

NASDAQ

Entity Emerging Growth Company

true

Elected Not To Use the Extended Transition Period

false

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Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

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Area code of city

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Cover page.

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For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

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The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

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No definition available.

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Address Line 1 such as Attn, Building Name, Street Name

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Name of the City or Town

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Code for the postal or zip code

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Name of the state or province.

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- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

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Indicate if registrant meets the emerging growth company criteria.

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Indicate if an emerging growth company has elected not to use the extended transition period for complying with any new or revised financial accounting standards.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

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Two-character EDGAR code representing the state or country of incorporation.

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The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

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-Publisher SEC

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The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

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- Definition

Local phone number for entity.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

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-Section 13e

-Subsection 4c

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Title of a 12(b) registered security.

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Name of the Exchange on which a security is registered.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

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Trading symbol of an instrument as listed on an exchange.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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-Name Securities Act

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-Section 425

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