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Valion Bio test finds signal linked to cell density

Valion says microbial fermentation is commonly tracked through glucose, pH and dissolved oxygen, which do not necessarily show cell health directly.

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Form Type
8-K

Rhea-AI Filing Summary

Valion Bio, Inc. (VBIO) announced that its wholly owned biologics contract development and manufacturing organization, Velocity Bioworks, completed an initial feasibility evaluation of LarmorBio’s BioScan-NMR™ platform. The evaluation found a strong correlation between the platform’s signal and optical density at 600 nm (OD600), a measurement used to estimate cell density. Valion described the results as an early signal that the system may capture information associated with microbial growth; the project remains an early-stage proof-of-concept.

The results support continued development of potential continuous, real-time, non-invasive monitoring of cell size, density, viability and phenotype in bioreactors. LarmorBio’s platform is being designed for closed-system measurements, which could reduce reliance on routine offline sampling. Valion says microbial fermentation is commonly monitored through indirect indicators such as glucose, pH and dissolved oxygen. Velocity intends to use the evaluation results to inform subsequent development, including assessment of closed-system and continuous-monitoring capabilities. The milestone came less than six months after Valion secured exclusive rights to the technology.

Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Optical density wavelength 600 nm OD600 is used to estimate cell density in liquid cultures.
Time from exclusive rights to milestone Less than six months Time between Valion securing exclusive rights to the technology and the initial feasibility milestone.
OD600 technical
"optical density at 600 nm or OD600"
OD600 is the optical density (light absorbance/scattering) of a liquid culture measured at 600 nanometers using a spectrophotometer. It serves as a quick, indirect measure of microbial cell concentration or culture turbidity: higher OD600 values generally indicate more cells. OD600 is a relative indicator, not an exact cell count; readings become non‑linear at high densities and vary with cell size, shape, instrument path length and suspended debris.
closed-system measurements technical
"through closed-system measurements"
proof-of-concept technical
"remains an early-stage proof-of-concept"
A proof-of-concept is a demonstration that shows a new idea or method can work as intended, serving as a small-scale test before full development. For investors, it signals that a concept has been successfully tested in principle, reducing uncertainty about whether it can be practically implemented. This helps determine if further investment or effort is justified to develop the idea further.
nuclear magnetic resonance technical
"next-generation microscale nuclear magnetic resonance"
A laboratory technique that uses strong magnets and radio waves to reveal the arrangement of atoms inside a molecule—think of it as an MRI for chemicals that lets scientists ‘see’ molecular structure and purity. Investors care because nuclear magnetic resonance (NMR) is a foundational tool in drug discovery, materials research and quality control: robust NMR data can validate a product’s composition, speed development, reduce regulatory risk and protect the value of intellectual property.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did VBIO’s BioScan-NMR feasibility evaluation show?

The initial feasibility evaluation found a strong correlation between the BioScan-NMR platform signal and optical density at 600 nm (OD600), a widely used measurement for estimating cell density in liquid cultures. Valion characterized this as an early signal that the platform may capture information associated with microbial growth, while describing the work as an early-stage proof-of-concept.

What else could VBIO’s BioScan-NMR platform monitor?

Valion said the system may provide visibility into media composition, the fermenter environment and process conditions, and potentially product-related attributes, without relying solely on routine invasive sampling and sample processing.

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false 0001787740 0001787740 2026-10-15 2026-10-15 iso4217:USD xbrli:shares iso4217:USD xbrli:shares
 

 

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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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:

 

oBring biological visibility directly into the manufacturing process, with the potential to detect deviations earlier
oReduce the risk of batch failures
oLower manufacturing costs
oEnable 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.1 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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