Valion Bio (Nasdaq: VBIO) hires Melinda Lackey as General Counsel

Rhea-AI Filing Summary

Valion Bio, Inc. appointed Melinda Lackey as General Counsel and Senior Vice President of Legal Affairs. She brings more than 18 years of legal and biotech experience, including senior roles at Alaunos Therapeutics and Kuur Therapeutics and prior IP-focused practice at major law firms.

Under her May 1, 2026 employment agreement, Ms. Lackey will receive a base salary of $321,000 per year, be eligible for an annual bonus of up to 35% of base salary, and may receive future equity grants under the 2021 Equity Incentive Plan. She also received an option to purchase 45,000 Valion Bio common shares at fair market value on the grant date.

If she resigns for good reason or is terminated without cause after at least six months, she is entitled to six months of base salary and six months of COBRA premiums. The company issued a press release highlighting her IP, clinical-stage, and Nasdaq public company experience as it advances Entolimod™ and its Velocity Bioworks CDMO operations.

8-K Event Classification

3 items: 5.02, 7.01, 9.01

3 items

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers Governance

Key personnel changes including departures, elections, or appointments of directors and executive officers.

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Base salary: $321,000 per year Target bonus: Up to 35% of base salary Stock options granted: 45,000 shares +3 more

6 metrics

Base salary $321,000 per year Compensation for General Counsel role under Employment Agreement

Target bonus Up to 35% of base salary Annual end-of-year incentive bonus eligibility

Stock options granted 45,000 shares Option to purchase common stock at fair market value on May 1, 2026

Cash severance 6 months of base salary If terminated without cause or resigns for good reason after six months

COBRA coverage period 6 months Company-paid COBRA following qualifying termination

Legal experience Over 18 years Combined legal and corporate experience in biotech and law firms

Key Terms

General Counsel, FDA Animal Rule, Orphan Drug, Fast Track, +2 more

6 terms

General Counsel financial

"Valion Bio Appoints Melinda Lackey as General Counsel Seasoned Biopharmaceutical Attorney"

A general counsel is the chief lawyer of an organization, responsible for overseeing all legal matters and ensuring the company complies with laws and regulations. Think of them as the organization's legal advisor or navigator, helping to prevent legal problems before they happen. Their role matters to investors because they help protect the company from legal risks that could impact its success and value.

FDA Animal Rule regulatory

"advancing Entolimod™ toward an FDA Animal Rule approval pathway for ARS"

A U.S. regulatory pathway that allows certain drugs or biological products to be approved based on well-controlled animal studies when human efficacy trials would be unethical or impossible, paired with human safety data. Think of it like approving a lifesaving device after convincing crash-test simulations because testing on real people would be harmful; for investors, it can shorten development time, change clinical risk, and affect the timeline and value of products aimed at rare, emergency, or biodefense uses.

Orphan Drug regulatory

"Entolimod™ has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration."

A drug designated for an orphan disease is a medicine developed to treat a rare condition that affects only a small number of people. Regulators often give these drugs special incentives—such as reduced costs, faster review, and temporary exclusive selling rights—to encourage development, which matters to investors because those incentives can make a small market financially viable and reduce competition, much like a temporary patent on a niche product.

Fast Track regulatory

"Entolimod™ has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration."

A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.

CDMO technical

"Velocity Bioworks ... is a full-service contract development and manufacturing organization (CDMO)"

A contract development and manufacturing organization (CDMO) is a company that provides specialized services to help develop and produce pharmaceutical products for other businesses. Think of it as a contract factory that takes a company's recipe and makes the product on their behalf. For investors, CDMOs are important because they support the growth of pharmaceutical companies and can be key partners in bringing new medicines to market.

Acute Radiation Syndrome medical

"developing Entolimod™ for Acute Radiation Syndrome (ARS) and oncology supportive care"

Acute radiation syndrome is the sudden illness that happens after a person absorbs a large dose of ionizing radiation in a short time, damaging blood cells, the gut, skin, and other organs. Think of it like a severe, internal burn that can impair a person’s ability to heal and fight infection. Investors watch it because outbreaks, accidents, or tests can trigger urgent regulatory action, reshape demand for medical treatments and protective equipment, create liability risks, and affect the operations and stock prices of companies in healthcare, energy, insurance, and related supply chains.

Understanding 8-K Material Events →

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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): May 1, 2026

Valion Bio, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware		001-41052		81-4016391
(State or Other Jurisdiction		(Commission File Number)		(IRS Employer
of Incorporation)				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

          Tivic Health Systems, Inc.          

(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. ☐

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

On May 4, 2026, Melinda Lackey was appointed as General Counsel and Senior Vice President of Legal Affairs of Valion Bio, Inc. (formerly known as Tivic Health Systems, Inc.), a Delaware corporation (the “Company”). Ms. Lackey, age 49, brings over 18 years of legal and corporate experience, and has served in executive and legal leadership roles at biotechnology companies and international law firms. Prior to joining the Company, from November 2021 until August 2025, Ms. Lackey served as Senior Vice President, Legal & Administration of Alaunos Therapeutics, Inc. (NASDAQ: TCRT). From August 2021 to November 2021, she served as Of Counsel at Hogan Lovells. Prior to that, Ms. Lackey served as General Counsel of Kuur Therapeutics, Inc. (f/k/a Cell Medica, Inc.), was a clinical-stage biotechnology company focused on CAR-NKT cellular therapies and later acquired by a global biopharmaceutical public company, from June 2018 to August 2021. Ms. Lackey previously practiced law at Winston & Strawn LLP from March 2008 to June 2018, where she focused on intellectual property strategy and patent litigation. Ms. Lackey earned a Bachelor of Science in microbiology from Texas Tech University in 1998. Ms. Lackey also earned a Master of Science in medical microbiology and immunology from Texas Tech University Health Sciences Center and a Doctor of Jurisprudence from University of Houston Law Center in 2007.

On May 1, 2026, in connection with her appointment as General Counsel and Senior Vice President of Legal Affairs of the Company, the Company and Ms. Lackey entered into an executive employment agreement (the “Employment Agreement”), pursuant to which Ms. Lackey (i) is entitled to receive a base salary of $321,000 per annum (subject to review and adjustment in accordance with the Company’s normal performance review practices); (ii) will be eligible to receive, at the sole discretion of the Company’s Board of Directors (“Board”), an annual end-of-year incentive bonus in an amount up to 35% of her base salary, commencing the year following the start of her employment; and (iii) may be eligible to receive annual focal grants, as determined by the Board or the Compensation Committee of the Board, pursuant to the Company’s Amended and Restated 2021 Equity Incentive Plan.

In addition to the foregoing compensation, on May 1, 2026, Ms. Lackey was granted an option to purchase 45,000 shares of common stock of the Company with an exercise price equal to the fair market value of a share of common stock of the Company on the grant date.

Pursuant to the Employment Agreement, Ms. Lackey’s employment is “at will,” meaning that either she or the Company are entitled to terminate Ms. Lackey’s employment at any time and for any reason, with or without cause. In the event that her employment with the Company is terminated for any reason before December 31 of any given year, she will not be entitled to receive an annual end-of-year bonus. In the event that (i) Ms. Lackey elects to terminate her employment with the Company other than for good reason, (ii) the Company terminates her employment for cause, or (iii) her employment is terminated as a result of her death or disability, then Ms. Lackey will not be entitled to receive any separation benefits. In the event that Ms. Lackey terminates her employment for good reason or the Company terminates her employment without cause, provided that her employment with the Company continues for at least six months after execution of the Employment Agreement, then Ms. Lackey shall be entitled to receive payment equal to her base salary for a period of six months after termination, payable in accordance with the Company’s standard payroll procedures, and the Company shall pay her COBRA coverage for a period of six months after termination.

The foregoing summary of the Employment Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Employment Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated herein by reference.

There are no arrangements or understandings, other than the employment agreement between the Company and Ms. Lackey described above, pursuant to which Ms. Lackey was appointed and there are no family relationships between Ms. Lackey and any of the Company’s directors, executive officers or persons nominated or chosen by the Company to become a director or executive officer. Ms. Lackey has not engaged in any related-person transactions required to be disclosed by Item 404(a) of Regulation S-K under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

2

Item 7.01 Regulation FD Disclosure.

On May 4, 2026, the Company issued a press release announcing Ms. Lackey’s appointment as General Counsel and Senior Vice President of Legal Affairs of the Company, among other things. 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.

Forward-Looking Statements

This Current Report including Exhibit 99.1, 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, including Exhibit 99.1, 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.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
10.1*		Executive Employment Agreement, by and between Valion Bio, Inc. and Melinda Lackey, dated May 1, 2026.
99.1		Press Release, dated May 4, 2026.
104		Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101).

* Certain annexes, schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant agrees to furnish supplementally a copy of any omitted attachment to the SEC on a confidential basis upon request.

3

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:	May 4, 2026	By:	/s/ Lisa Wolf
			Name: Lisa Wolf Title: Chief Financial Officer

4

Exhibit 99.1

Valion Bio Appoints Melinda Lackey as General Counsel

Seasoned Biopharmaceutical Attorney with Deep IP, Clinical-Stage, and Nasdaq Public Company Experience Joins Leadership Team

SAN ANTONIO, MAY 4, 2026 /PRNewswire/ Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO), a clinical-stage immunotherapeutics company developing Entolimod™ for Acute Radiation Syndrome (ARS) and oncology supportive care, today announced the appointment of Melinda Lackey as General Counsel and Senior Vice President of Legal Affairs. Ms. Lackey brings nearly two decades of combined scientific and legal experience across clinical-stage biopharmaceutical development, intellectual property strategy, and Nasdaq public company governance, a profile built for Valion Bio’s current phase of growth.

Ms. Lackey joins from Alaunos Therapeutics (Nasdaq: TCRT), a clinical trial-stage oncology cell therapy company, where she served as Senior Vice President of Legal & Administration. In that role, she managed all legal and compliance functions for the publicly traded immunology company, navigating complex clinical development, regulatory strategy, and capital markets obligations. Prior to Alaunos, she served as Senior Legal Counsel at Kuur Therapeutics, a clinical trial-stage biopharmaceutical company focused on cellular immunotherapies, where she developed expertise in the legal architecture of next-generation immunological platforms.

Before transitioning in-house, Ms. Lackey was an associate at Winston & Strawn LLP and Howrey LLP, two firms with nationally recognized intellectual property and life sciences practices, where she built a strong foundation in patent litigation and prosecution, IP portfolio strategy, and biopharmaceutical transactions. Her legal training is further distinguished by an early career as a Research Associate at the University of Texas Health Science Center at Houston and a Research Technician at UT MD Anderson Cancer Center. She holds her J.D. from the University of Houston Law Center.

The appointment comes as Valion Bio is in the process of advancing Entolimod™ toward an FDA Animal Rule approval pathway for ARS, and scaling its wholly owned CDMO subsidiary Velocity Bioworks in San Antonio. Ms. Lackey’s transactional, IP, and public company governance experience positions her to support all of these workstreams simultaneously.

“Melinda’s appointment reflects Valion Bio’s direction. She has built her career at the intersection of cutting-edge immunotherapy and the legal strategy that protects it, from the bench at MD Anderson to senior legal leadership at a Nasdaq-listed cell therapy company. As we work to execute our capital raise, advance Entolimod™ through the Animal Rule pathway, and scale Velocity Bioworks, having an in-house General Counsel with her depth of scientific literacy, IP acumen, and public company experience is a strategic imperative," said Michael K. Handley, Chief Executive Officer of Valion Bio, Inc.

Ms. Lackey commented, “I am excited to join Valion Bio at such a consequential moment in its evolution. The science behind Entolimod™ and Entolasta™ is compelling, and the combination of a clinical-stage pipeline, a government-aligned countermeasures program, and a fully operational CDMO subsidiary creates a legal environment that demands both precision and creativity. I look forward to contributing to the company’s mission of activating innate immunity to protect and extend life.”

About Valion Bio, Inc.

Valion Bio, Inc. (formerly Tivic Health Systems, Inc.) (Nasdaq: VBIO) is a clinical-stage immunotherapeutics company developing Entolimod™, a TLR5 agonist, for Acute Radiation Syndrome (ARS) via the FDA Animal Rule pathway, oncology supportive care (neutropenia), and longevity indications. Entolimod™ has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration. The company is also advancing Entolasta™, a next-generation TLR5 agonist. Valion Bio’s wholly owned subsidiary, Velocity Bioworks (San Antonio, TX), is a full-service contract development and manufacturing organization (CDMO) offering biomanufacturing services to third-party biotech companies. For more information, visit www.valionbio.com.

1

Forward-Looking Statements

This press release may contain “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 contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Valion Bio, Inc.’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of 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 ability of the company to achieve the expected benefits from the acquisition of development and manufacturing assets within expected time frames or at all; changes to the company’s relationship with its partners; failure to obtain FDA or similar clearances or approvals and noncompliance with FDA or similar regulations, including related to the Animal Rule; the company’s future development of Entolimod or Entolasta; changes to the company’s business strategy; timing and success of pre-clinical and clinical trials and study results; regulatory requirements and pathways for approval; the company’s ability to successfully commercialize its product candidates in the future; changes in the markets and industries in which the company does business; consummation of any strategic transactions; the company’s need for, and ability to secure when needed, additional working capital; the company’s ability to maintain its Nasdaq listing; and changes in tariffs, inflation, legal, regulatory, political and economic risks. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Valion Bio’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 30, 2026, under the heading “Risk Factors”, as well as the company’s subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and the company undertakes no duty to update such information except as required by applicable law.

Investor Contact

Rich Cockrell

CG Capital

rich@cg.capital

SOURCE: Valion Bio, Inc.

2

FAQ

What executive change did Valion Bio (TIVC/VBIO) disclose in this 8-K?

Valion Bio appointed Melinda Lackey as General Counsel and Senior Vice President of Legal Affairs. She joins with extensive biopharmaceutical, intellectual property, and Nasdaq public company experience to support Entolimod™ development and the company’s Velocity Bioworks CDMO subsidiary.

What is Melinda Lackey’s compensation package at Valion Bio (TIVC)?

Ms. Lackey will receive a $321,000 base salary per year, eligibility for an annual bonus up to 35% of base salary, potential future equity grants, and an initial option to purchase 45,000 common shares at fair market value on the grant date.

What severance terms apply to Valion Bio’s new General Counsel?

If Ms. Lackey resigns for good reason or is terminated without cause after six months, she receives six months of base salary and six months of COBRA health coverage. No separation benefits are provided if she leaves voluntarily without good reason or is terminated for cause.

What is Valion Bio’s core business focus mentioned in the filing?

Valion Bio is a clinical-stage immunotherapeutics company developing Entolimod™, a TLR5 agonist, for Acute Radiation Syndrome via the FDA Animal Rule pathway, oncology supportive care, and longevity uses, and advancing Entolasta™ alongside its Velocity Bioworks biomanufacturing services subsidiary.

What equity award did Valion Bio grant to its new General Counsel?

On May 1, 2026, Valion Bio granted Ms. Lackey an option to buy 45,000 common shares at an exercise price equal to the fair market value of the stock on the grant date, aligning part of her compensation with future company performance.

How does Valion Bio describe the strategic timing of this legal hire?

Valion Bio states the appointment comes as it advances Entolimod™ toward the FDA Animal Rule pathway for ARS and scales Velocity Bioworks. The company highlights Ms. Lackey’s IP, clinical-stage, and governance experience as supporting these concurrent strategic workstreams.

Filing Exhibits & Attachments

5 documents

Press Releases

• EX-99.1 PRESS RELEASE 14.0 KB

Agreements & Contracts

• EX-10.1 TIVIC HEALTH EXECUTIVE EMPLOYMENT AGREEMENT 66.0 KB

Other Documents

• EX-101 XBRL SCHEMA FILE 2.9 KB
• EX-101 XBRL LABEL FILE 34.1 KB
• EX-101 XBRL PRESENTATION FILE 22.2 KB