Valion Bio 子公司 Velocity Bioworks 完成 LarmorBio BioScan-NMR 平台初步可行性验证，仅为早期概念验证里程碑

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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 15, 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 15,
2026, Valion Bio, Inc. (the “Company”) issued a press release announcing completion of an initial feasibility evaluation of
LarmorBio's BioScan-NMR™ platform.
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 15, 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.
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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 15, 2026
By:
/s/ Dean Zikria
Name: Dean Zikria
Title: Interim Chief Executive Officer
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EX-99.1
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valion_ex9901.htm
PRESS RELEASE, DATED OCTOBER 15, 2026
Exhibit 99.1
Valion Bio’s Next-Generation NMR Partnership with LarmorBio Delivers
Initial Feasibility Milestone
Velocity Bioworks successfully completes initial
evaluation of LarmorBio’s BioScan-NMR™ platform, generating data supporting the continued development of continuous, real-time,
non-invasive bioprocess monitoring of cell size, density,
viability,
and phenotype within bioreactors
Milestone achieved less than six months after
Valion Bio secured exclusive rights to LarmorBio’s next-generation NMR technology
SAN ANTONIO, TX and WALTHAM, MA / October
15, 2026 / ACCESS Newswire
– Valion Bio, Inc. (NASDAQ: VBIO) (“Valion” or the “Company”) and LarmorBio,
Inc. (“LarmorBio”) today announced that Velocity Bioworks, Valion’s wholly owned biologics contract development and
manufacturing organization (“CDMO”) subsidiary, has successfully completed an initial feasibility evaluation of LarmorBio’s
BioScan-NMR™ platform.
·
BioScan-NMR™ is being developed to create a new class of process analytical technology (“PAT”)
for biologics manufacturing.
·
The initial feasibility evaluation demonstrated that nuclear magnetic resonance (“NMR”) measurements
have the potential to track microbial growth during a fermentation process.
·
Building on that foundation, LarmorBio is developing a real-time, continuous monitoring platform designed
to:
o
Bring biological visibility directly into the manufacturing process, with the potential to detect deviations
earlier
o
Reduce the risk of batch failures
o
Lower manufacturing costs
o
Enable more consistent and efficient production.
“Innovation and differentiation are increasingly
important competitive advantages in the CDMO industry, and this milestone represents what we believe is meaningful progress in our strategy
to bring new, clearly differentiated technology into our bioprocessing capabilities,” said Dean Zikria, Interim Chief Executive
Officer of Valion. He continues, “We are particularly encouraged by this initial achievement and the potential for BioScan-NMR™
to further differentiate Velocity Bioworks.”
Initial Data Supports Continued Development
The initial feasibility evaluation captured a
strong correlation between the signal measured by the BioScan-NMR™ platform and optical density at 600 nm or OD600, a widely used
biological measurement for estimating cell density in liquid cultures, providing an encouraging early signal that the BioScan-NMR™
platform has the potential to capture information associated with microbial growth.
“While this project remains an early-stage
proof-of-concept, the initial results are encouraging,” added Mr. Zikria. “We believe BioScan-NMR™ has the potential
to provide greater visibility into fermentation processes, including information related to the media composition, fermenter environment,
process conditions, and potentially product-related attributes - without relying solely on routine invasive sampling and sample processing.
We look forward to the full implementation of this unique PAT system at Velocity Bioworks.”
Microbial fermentation can offer important advantages
over mammalian cell culture for certain biologics and smaller-molecule production processes, including potentially faster production cycles,
lower operating costs, and suitability for high-throughput or specialized manufacturing applications.
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However, effective process
monitoring remains critical to maintaining consistency, optimizing yields, and identifying changes in a fermentation process.
1
Today, microbial fermentation is commonly monitored
using indirect indicators of metabolic activity, including glucose, pH, and dissolved oxygen. While these measurements furnish important
information about process conditions and cellular growth, they do not necessarily provide a direct view of cell health or other underlying
biological changes.
LarmorBio’s next-generation BioScan-NMR™
technology platform is being designed for its potential to address monitoring gaps through closed-system measurements that could reduce
reliance on routine offline sampling. By reducing or potentially eliminating the need for repeated invasive sampling, the technology could
help preserve the sterile barrier while enabling real-time, continuous, and non-invasive visibility into key biological parameters.
2,3,4
“The potential to move beyond episodic sampling
toward continuous process visibility is particularly compelling from a CDMO perspective,” concluded Mr. Zikria. “If subsequent
development work confirms that BioScan-NMR™ can reliably monitor additional critical process attributes in a closed system, it could
become an important enabling technology for more data-rich, responsive, and efficient bioprocessing.”
Velocity Bioworks intends to use the results of the
initial feasibility evaluation to inform subsequent development activities, including assessment of the closed-system and continuous monitoring
capabilities.
Sources
1
Single Use Support, “Differences
between microbial fermentation & mammalian cell culture,” https://www.susupport.com/blogs/manufacturing-processes/differences-between-microbial-fermentation-mammalian-cell-culture
2
Hans Gaensbauer, Do Hyun Park, Alexander Bevacqua, Jongyoon
Han, “Contact Free On-Line Monitoring of Bioreactor Cell Cultures with Magnetic Resonance Relaxometry,” Analytical Chemistry,(2024)
https://pubs.acs.org/doi/10.1021/acs.analchem.4c04042
3
Tan, J., Chen, J., Roxby, D. et al. Using magnetic resonance
relaxometry to evaluate the safety and quality of induced pluripotent stem cell-derived spinal cord progenitor cells. Stem Cell Res Ther
15, 465 (2024). https://stemcellres.biomedcentral.com/articles/10.1186/s13287-024-04070-y
4
Tee, C.A., Roxby, D.N., Othman, R. et al. Metabolic modulation
to improve MSC expansion and therapeutic potential for articular cartilage repair. Stem Cell Res Ther 15, 308 (2024). https://doi.org/10.1186/s13287-024-03923-w
About LarmorBio, Inc.
LarmorBio, Inc. is a life sciences and clinical
diagnostics company developing the BioScan-NMR™ platform, a next-generation microscale nuclear magnetic resonance (“NMR”)
system for rapid, label-free phenotyping of live cells and micro-sized biological samples. Founded as a Massachusetts Institute of Technology
(MIT) spin-off, LarmorBio’s technology is designed to deliver molecular-level diagnostic information from small sample volumes in
minutes, without the cryogenics, dedicated infrastructure, or specialized personnel required by conventional NMR instrumentation. The
Company’s platform supports applications across bioprocessing, cell and gene therapy development, and clinical diagnostics.
For more information, visit www.larmorbio.com.
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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. Forward-looking statements in this press release include, among others, statements regarding: the development and regulatory
advancement of Entolimod under the FDA Animal Rule; the timing and outcome of regulatory or government interactions
; the
potential
to move from episodic sampling toward continuous process visibility using nuclear magnetic resonance during microbial fermentation-based
biologics manufacturing; the addressable opportunity scale, interest and/or success, the initiation, design, timing and outcome of investigator-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; and the Company’s ability to obtain additional capital and the continued listing
of the Company’s common stock 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
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