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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): October 14, 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 8.01.
Other Matters.
On October 14,
2026, Valion Bio, Inc. (the “Company”) issued a press release regarding its wholly owned subsidiary, Velocity Bioworks, Inc.
A copy of the
press release is filed as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated herein
by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
|
Exhibit
Number |
|
Description |
| 99.1 |
|
Press Release, dated October 14, 2026. |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
Forward-Looking Statements
This Current Report, including Exhibit 99.1 attached hereto, 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
attached hereto, or hereafter, including in other publicly available documents filed with the Securities and Exchange Commission (the
“SEC”), 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 SEC,
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 and adversely 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: |
October 14, 2026 |
By: |
/s/ Dean Zikria |
| |
|
|
Name: Dean Zikria
Title: Interim Chief Executive Officer |
Exhibit 99.1
With Section 232 Tariffs Reshaping Biotech, Valion Bio’s Velocity
Bioworks Capitalizes on Domestic CDMO Surge
Velocity Bioworks’ San Antonio facility offers process development,
analytical services and early-phase clinical drug substance manufacturing for biotechnology companies evaluating U.S.-based production
SAN ANTONIO, TX / October 14, 2026 / ACCESS Newswire -- Valion
Bio, Inc. (NASDAQ:VBIO) (“Valion” or the “Company”), a clinical-stage biopharmaceutical company developing biologics
that activate innate immune pathways for cytoprotection and immune modulation, today highlighted the capabilities of its wholly owned
contract development and manufacturing organization (“CDMO”), Velocity Bioworks. Velocity Bioworks (“Velocity”)
is part of Valion’s own domestic biologics supply chain, supporting the Company’s development strategy for its lead candidate,
Entolimod, which is being developed as a potential medical countermeasure for Acute Radiation Syndrome.
Velocity Bioworks can support biotechnology companies evaluating U.S.-based
manufacturing for early-phase biologics programs. The announcement comes amid increased industry focus on domestic pharmaceutical manufacturing
following implementation of the new Section 232 pharmaceutical tariff framework.1 It imposes tariffs of up to 100% on certain
imported patented pharmaceuticals and associated pharmaceutical ingredients, with lower rates or exemptions based on product, origin and
other applicable criteria. The framework took effect for most companies on September 29, 2026.2
“Biotechnology companies may benefit from establishing U.S.-based
manufacturing early in development as part of a longer-term domestic supply-chain strategy,” said Valion’s Interim CEO Dean
Zikria. “Doing so can help avoid a more complex process transfer closer to launch. Velocity Bioworks is designed to provide clinical
sponsors with access to process development, analytical services and GMP drug substance manufacturing for early clinical development at
its integrated San Antonio campus. We welcome discussions with potential partners about how Velocity can support their development and
manufacturing needs.”
Velocity Bioworks’ microbial manufacturing facility is equipped
for GMP drug substance manufacturing at scales up to 200 liters. Velocity also maintains GMP mammalian manufacturing capabilities to support
biologics programs through early clinical development. Phase-appropriate process and analytical development services are intended to enable
technology transfer, product characterization, stability and comparability activities across development and clinical manufacturing programs.
Velocity’s San Antonio manufacturing site provides convenient
access to San Antonio International Airport and the region’s transportation and logistics infrastructure.
“As a biopharmaceutical company developing our own biologic drug
candidates, including Entolimod, Valion understands the importance of aligning domestic manufacturing capabilities with development objectives,”
added Mr. Zikria. “Velocity Bioworks reflects that commitment, with capabilities designed to support both our internal programs
and external partners.”
Sources
1
PharmaSource, “Section 232 Pharma Tariffs Expand Today: What Manufacturers Need to Know,” September 29, 2026, https://pharmasource.global/content/policy-briefing/section-232-pharma-tariffs-expand-today-what-manufacturers-need-to-know
2
U.S. Department of Commerce, Bureau of Industry and Security. Federal Register, September 23, 2026, 91 FR 60360–60366, document
2026-19498. https://www.govinfo.gov/content/pkg/FR-2026-09-23/html/2026-19498.htm
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 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.
Valion’s wholly owned subsidiary, Velocity Bioworks, is a biologics
contract development and manufacturing organization providing development and manufacturing services to Valion to support its internal
pipeline, with the objective of increasing manufacturing control, reducing costs, accelerating development timelines and strengthening
domestic supply-chain security.
For more information, visit www.valionbio.com.
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’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.
Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including,
without limitation: the continued listing of the Company’s common stock on the Nasdaq Capital Market; and the Company’s ability
to maintain compliance with applicable listing standards on the Nasdaq Capital Market. Given these risks and uncertainties, you are cautioned
not to place undue reliance on such forward-looking statements. For a discussion of other risks and uncertainties, and other important
factors, any of which could cause Valion’s actual results to differ from those contained in the forward-looking statements, see
Valion’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 Valion undertakes no duty to update such information except as
required by applicable law.
Investor and Media Contact
Stephen Kilmer
(646) 274-3580
stephen.kilmer@valionbio.com
