Every 8-K that Valion Bio, Inc. (VBIO) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow VBIO and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full VBIO filings page.
On October 7, 2026, Valion Bio, Inc. (VBIO) entered into a letter agreement with 3i, LP under which 3i agreed to purchase 50 Series B Preferred Shares and warrants to purchase 1,539 common shares for an aggregate purchase price of $50,000. The closing is subject to satisfaction or waiver by 3i of the letter agreement’s conditions.
The warrants have an initial exercise price of $2.5520 per share. The securities were issued under an exemption from registration pursuant to Section 4(a)(2) and/or Rule 506(b).
Valion Bio, Inc. (VBIO) outlined new Board Chair Thomas H. Jensen’s perspectives on advancing Entolimod. Jensen has served as chair since September 2026 and brings more than 20 years of biotechnology and oncology experience.
Entolimod is an investigational Toll-like receptor 5 (TLR5) agonist being developed as a potential medical countermeasure for acute radiation syndrome (ARS). Its development has been supported by approximately $35.6 million in non-dilutive funding from several U.S. government agencies, and it holds FDA Fast Track and Orphan Drug designations for ARS. The company also cites human safety data and supply-chain control through its wholly owned U.S.-based CDMO subsidiary, Velocity Bioworks. Jensen said he sees longer-term potential to explore the molecule in cancer supportive care.
Valion Bio, Inc. (VBIO) and Shear Kershman Laboratories completed formulation work on an oral mucosal version of Entolimod using SKL’s BioViscid™ drug-delivery platform. The next study will test whether the formulation delivers measurable amounts of Entolimod into the bloodstream and, if so, characterize the absorption’s pharmacokinetic profile.
Valion says that, if successfully developed and authorized or approved, the U.S. dose requirement could be approximately 10 to 40 times that of its injectable program. The estimate assumes supplying about 2.0 million active-duty and Selected Reserve service members, 1.0 million firefighters and 790,000 full-time sworn law enforcement officers; it is not a revenue forecast, an estimate of committed purchases or a measure of demonstrated demand. Valion said its injectable program remains a priority.
Valion Bio, Inc. (VBIO) appointed Board member Dean Zikria interim Chief Executive Officer effective September 22, 2026; he remains a director. Under a consulting agreement, he is entitled to a $23,333 monthly fee and 50,000 restricted stock units (RSUs). Another 50,000 RSUs are contingent on an increase to the equity plan by stockholders and approval by the Board’s Special Committee. A cash bonus may be awarded upon closing a reverse merger, merger, or acquisition, as determined by the Board or its Compensation Committee. The agreement is scheduled to terminate January 22, 2027, unless mutually extended for up to 12 months from its effective date.
Sheryle Bolton resigned from the Board effective September 17, 2026; the company stated her resignation did not result from a disagreement. Thomas Jensen became Board and Compensation Committee chair, and Jared Malbin became Audit and Risk Committee chair. While serving as interim CEO, Zikria was removed as an independent member of three Board committees. Lisa Wolf continues as President, Chief Operating Officer, and Chief Financial Officer, reporting to Zikria.
Valion Bio, Inc. (VBIO) entered into a new letter agreement with 3i, LP under existing preferred stock purchase arrangements. Valion will issue 100 Series B Non-Voting Convertible Preferred Shares, 7,637 Series C Non-Voting Convertible Preferred Shares, Series B Warrants for 3,077 common shares at $3.62, and Series C Warrants for 1,053,969 common shares at $3.62, for an aggregate purchase price of $7,737,000.
Of this amount, $6,137,000 will be retained by 3i to satisfy overdue cash true-up payments, $100,000 will cover 3i’s legal fees, and $1,500,000 will be paid to Valion in cash. The warrant share counts and exercise prices reflect a 1-for-25 reverse stock split effective at 12:01 a.m. Eastern Time on August 31, 2026. Valion agreed to file and maintain a resale registration statement for the shares underlying the new preferred stock and warrants.
Separately, Lisa Wolf, already Chief Financial Officer, has been appointed President and Chief Operating Officer and will assume executive leadership following the departure of former CEO Michael K. Handley. The company also added two new directors, Jared Malbin, with extensive capital-markets and regulatory experience, and Thomas Jensen, CEO of Allarity Therapeutics with biotechnology and oncology expertise.
Valion Bio, Inc. (VBIO) announced that its board and stockholders have approved a 1-for-25 reverse stock split of its common stock. The reverse split will become effective on August 31, 2026 at 12:01 a.m. Eastern Time, after which the stock will trade on a split-adjusted basis on the Nasdaq Capital Market under the symbol “VBIO” with a new CUSIP 918942202.
The stated purpose is to help regain compliance with Nasdaq’s $1.00 minimum bid price requirement before the compliance period ending September 15, 2026. Every 25 existing shares will be combined into one share, with no cash paid for fractional shares; any fractional amounts will be rounded up to the nearest whole share. Authorized share counts and par value remain unchanged, and each stockholder’s percentage ownership and voting power are expected to remain materially the same aside from rounding effects.
Valion Bio, Inc. (VBIO) reported final voting results from its August 14, 2026 Special Meeting of Stockholders. Common stock was the only voting class, with 4,151,259 shares outstanding as of the July 7, 2026 record date, and 2,001,335 shares present, representing approximately 48.21% and establishing a quorum.
Stockholders approved granting the board of directors discretionary authority to amend the certificate of incorporation to implement a reverse stock split of the common stock at a ratio between 1-for-5 and 1-for-50, to be selected by the board within twelve months of the meeting, without further stockholder approval. Stockholders also approved a proposal authorizing potential adjournment to solicit additional proxies, although the meeting was not adjourned because the reverse split authority had already been approved.
Valion Bio, Inc. entered into a letter agreement with 3i, LP for a new funding tranche under its existing Series B Preferred Purchase Agreement. The company agreed to issue 1,500 Series B Non-Voting Convertible Preferred Shares at $1,000 per share plus related Series B warrants for an aggregate purchase price of $1,500,000, with closing expected on or about August 17, 2026, in a transaction exempt from registration under Section 4(a)(2) and/or Rule 506(b).
Valion also agreed that 3i and other investors will receive payments under a new Royalty Agreement equal to 5% of gross revenue of subsidiary Velocity Bioworks, Inc. from third parties for 10 years. Lisa Wolf was appointed Chief Operating Officer while continuing as Chief Financial Officer, and Michael K. Handley was terminated as Chief Executive Officer, both effective August 16, 2026.
At an August 14, 2026 special meeting, stockholders approved granting the board authority to implement a reverse stock split at a ratio between 1-for-5 and 1-for-50 within twelve months, and also approved a proposal allowing adjournment of the meeting to solicit additional proxies if needed.
Valion Bio, Inc. reports achieving its first development milestone under its amended exclusive license with Statera Biopharma for the TLR5 agonist Entolimod in the Acute Radiation Syndrome indication. Validation of current inventory for distribution and sales triggered a $750,000 milestone payment, the first portion of up to $1,750,000 in ARS development milestones and part of broader obligations that may direct up to $5.6 million of subsequent payments to Avenue Capital on Statera’s behalf. Additional cash-or-stock milestones are outlined for potential Neutropenia indications.
To satisfy the Milestone Payment, Valion issued an aggregate of 1,287.8685 shares of Series A Non-Voting Convertible Preferred Stock as Milestone Shares to Statera and Avenue under a securities purchase agreement that includes resale registration rights for the underlying common stock within 60 calendar days following the Closing Date. These unregistered securities were sold to accredited investors under Section 4(a)(2) and Regulation D and are restricted, with conversion limited so each holder’s beneficial ownership remains between 4.9% and 19.9% of outstanding common shares.
Valion Bio, Inc. provided a business update on its Entolimod program and broader TLR5 platform. Entolimod is being developed as a potential medical countermeasure for Acute Radiation Syndrome under the FDA Animal Rule and has received Fast Track and Orphan Drug designations. The company reports ongoing engagement with BARDA, NIAID, AFRRI, the U.S. Department of War and Ukraine’s Ministry of Health regarding possible development support, regulatory pathways and Strategic National Stockpile or national reserve opportunities, while emphasizing that no funding, procurement or stockpiling agreements have been executed.
Through its wholly owned CDMO subsidiary Velocity Bioworks, Valion Bio has demonstrated an approximately 200-fold Entolimod manufacturing scale-up at the 50-liter fermentation scale, which it estimates is equivalent to about 1.3 million potential human doses, meeting applicable purity and potency specifications. Velocity Bioworks is intended to support both internal programs and third-party biologics manufacturing, though the company notes that material third-party revenue has not yet been established.
Valion Bio is expanding beyond biodefense into oncology supportive care, with planned physician-sponsored studies of Entolimod in neutropenia and continued development of Entolasta, a next-generation TLR5 agonist targeting oncology supportive care and immune dysfunction. The company states that more than $140 million has been invested in Entolimod’s development to date and that successful execution of its integrated platform strategy will depend on regulatory progress, government decisions, manufacturing performance, access to capital and clinical outcomes.
Valion Bio, Inc. disclosed a new tranche closing under its existing Securities Purchase Agreement. On June 17, 2026, the company issued 250 shares of Series B Non-Voting Convertible Preferred Stock at $1,000 per share and a warrant to purchase 156,026 shares of common stock at an exercise price of $0.616280 per share, for total proceeds of $250,000 from investor 3i, LP. The agreement, originally signed in April 2025 and later assigned to 3i, allows for sales of up to 8,400 Series B preferred shares and related warrants for up to $8,400,000. These securities were issued in a private placement relying on exemptions under Section 4(a)(2) and Rule 506(b) of the Securities Act.
Valion Bio, Inc. reported results from its 2026 annual stockholder meeting and an amendment to its equity plan. Stockholders approved a change to the 2021 Equity Incentive Plan to increase the shares of common stock authorized for issuance under the plan by 2,581,608 shares, effective May 28, 2026.
As of the April 24, 2026 record date, 3,139,095 shares of common stock were issued and outstanding, and 1,569,734 shares, or about half of those eligible, were represented, establishing a quorum. Investors also elected one Class II director, ratified the 2026 auditor, and approved multiple proposals under Nasdaq Listing Rule 5635(d) authorizing potential issuances of common stock tied to preferred stock, a senior secured convertible note, warrants, and a common stock purchase agreement with Tumim Stone Capital, LLC.
Valion Bio, Inc., formerly Tivic Health Systems, reported its first full quarter under its new identity, highlighting progress on its TLR5 immunotherapy platform and integrated manufacturing arm Velocity Bioworks for the three months ended March 31, 2026.
The company advanced Entolimod toward potential approval under the FDA's Animal Rule for acute radiation syndrome and continued developing Entolasta, a next-generation TLR5 agonist aimed at oncology supportive care, longevity, and immunosenescence. Engagement with U.S. agencies including NIAID, BARDA and other federal stakeholders expanded around potential procurement and stockpiling.
Velocity Bioworks' San Antonio facility supported internal Entolimod manufacturing while pursuing third-party CDMO opportunities in what management describes as an underserved Phase I and II biologics market. Operating expenses rose to $5.6 million from $1.4 million a year earlier, driven by the Velocity acquisition, Entolimod development, and rebranding costs. Net loss was $6.2 million ($2.23 per share) versus $1.5 million ($2.52 per share). Cash and cash equivalents were $7.2 million at March 31, 2026, down from $12.6 million at December 31, 2025, and the company is evaluating capital alternatives to fund its pipeline, regulatory, and manufacturing milestones.