Avaí Bio and Austrianova Complete GMP Master Cell Bank, Begin Viral Testing for Cell-Based Klotho Anti-Aging Therapy

Rhea-AI Summary

Avaí Bio (OTCQB: AVAI) and joint venture partner Austrianova completed a GMP-compliant Master Cell Bank (MCB) of genetically modified cells overexpressing the α-Klotho “longevity protein.” Comprehensive third-party viral and adventitious agent testing will now begin to meet regulatory expectations, including FDA standards.

After successful testing, a Working Cell Bank will be generated to manufacture the final Cell-in-a-Box® encapsulated clinical product. The milestone advances Klothonova, their Nevada-based, 50/50 joint venture formed in September 2025 to develop cell-based α-Klotho anti-aging and age-related disease therapies.

AI-generated analysis. Not financial advice.

Positive

• GMP Master Cell Bank of α-Klotho overexpressing cells completed
• Independent third-party viral and adventitious agent testing initiated
• Enables creation of Working Cell Bank for clinical product manufacturing
• Supports future Cell-in-a-Box encapsulated α-Klotho clinical therapy
• Strengthens scalable, GMP-compliant supply chain for cell-based treatments
• Progress under 50/50 Klothonova joint venture formed September 2025

Negative

• None.

LAS VEGAS, May 20, 2026 /PRNewswire/ -- Avaí Bio, Inc. (OTCQB: AVAI) ("Avaí" or the "Company"), an emerging biotechnology company developing transformative cell-based therapies for diabetes, age-related disorders, and anti-aging, today announced—together with its joint venture partner and global biotechnology firm, Austrianova— a major milestone in the Company's path to clinical trials, the completion of a Master Cell Bank (MCB) of genetically modified cells that overexpress the α-Klotho protein.

Now, the MCB will undergo comprehensive testing to confirm the absence of pathogenic viruses, as well as standard assays to verify the MCB is free from adventitious agents such as bacteria, mycoplasma, fungi, and yeast to meet regulatory expectations, including those set by the FDA. This testing will be conducted independently by a top-tier, accredited third-party provider, separate from Austrianova, Avaí Bio, and their combined joint venture, Klothonova. Following successful completion, the next step will be the generation of a "Working Cell Bank" (WCB) using α-Klotho protein–overexpressing cells derived from the MCB. These cells will be used to manufacture the final Cell-in-a-Box^® encapsulated clinical product.

A Master Cell Bank is a GMP-compliant, fully characterized, and homogeneous collection of vials derived from a single clone. It serves as the critical starting material for the scale-up and production of cell therapies, ensuring product consistency while reducing risk by protecting against contamination, degradation, extraneous agents, and genetic instability. By establishing and maintaining a high-quality MCB as the primary source for all Working Cell Banks under Good Manufacturing Practice (GMP) standards, Avaí Bio and Austrianova strengthen the foundation for a reliable, scalable, and sustainable supply chain.

This milestone marks a significant step forward in Klothonova's mission to develop a sustainable, cell-based approach to restoring declining levels of the α-Klotho "longevity protein" associated with aging. The approach is intended to address both general aging¹ and age-related conditions, including kidney disease, neurodegenerative disorders, and vascular diseases².

"We are pleased that this first step in the production phase of α-Klotho producing cells has been successfully completed. We look forward to the completion of the subsequent steps needed to fulfill our commitment to deliver safe, effective treatments for the ever-burgeoning array of aging associated diseases," said Chris Winter, Chief Executive Officer of Avaí Bio.

Dr Brian Salmons, Chief Executive Officer of Austrianova, added, "The Austrianova team is pleased to have completed the production of the α-Klotho protein expressing cells on behalf of Klothonova, our Joint Venture with Avaí Bio. We look forward to completing the next steps that will culminate with the production of Cell-in-a-Box^® encapsulated clinical product for application to patients."

This milestone represents the most recent progress under the joint venture agreement signed in September 2025, which established Klothonova as a Nevada-based company equally owned by Avaí Bio and Austrianova's affiliate, SG Austria Pte. Ltd. The joint venture is dedicated to the sustainable production of α-Klotho—often referred to as the "longevity protein"—a key regulatory protein widely recognized for its anti-aging properties and protective effects on multiple organs, delivered through encapsulated cell-based therapies for patients.

1. https://www.mdpi.com/2073-4409/15/6/507
2. https://www.dovepress.com/klotho-protein-a-multifaceted-guardian-of-healthy-aging-and-its-therap-peer-reviewed-fulltext-article-IJN

About Avaí Bio, Inc.

Avaí Bio, Inc. is an emerging biotechnology company focused on identifying genetically modified cell lines, and through joint venture and licensing agreements developing innovative cell-based therapies.

About Austrianova (SGAustria Pte. Ltd.)

Austrianova, based in Singapore, is a leading biotechnology company specializing in cell encapsulation, GMP-grade cell products, and cell line development, backed by over 50 peer-reviewed publications and partnerships with global pharmaceutical and biotech companies.

More information about Avaí Bio can be found at https://www.avaibio.com

You can also follow us on social media at:

https://x.com/AvaiBio
https://www.facebook.com/AvaiBio

Forward-Looking Statements

Certain statements contained in this press release may constitute "forward-looking statements."  Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact.  Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website (http://www.sec.gov).  In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company's ability to raise capital on acceptable terms, if at all, the Company's successful development of its products and the integration into its existing products and the commercial acceptance of the Company's products.  The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change.  However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.  These forward-looking statements should not be relied upon as representing the Company's views as of any date after the date of the press release.

Contact:
Avaí Bio, Inc.
info@avaibio.com

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FAQ

What milestone did Avaí Bio (OTCQB: AVAI) announce on May 20, 2026 for its Klotho therapy?

Avaí Bio announced completion of a GMP Master Cell Bank of α-Klotho overexpressing cells. According to Avaí Bio, this bank is critical starting material for scaling production of its Cell-in-a-Box® encapsulated, cell-based Klotho anti-aging and age-related disease therapy.

What is the purpose of the new GMP Master Cell Bank in Avaí Bio’s AVAI Klotho program?

The new GMP Master Cell Bank provides a fully characterized, homogeneous source of α-Klotho producing cells. According to Avaí Bio, it ensures consistency, reduces contamination risk, and underpins all Working Cell Banks used to manufacture the clinical Cell-in-a-Box® product.

What testing will the Avaí Bio (AVAI) Klotho Master Cell Bank undergo before clinical use?

The Master Cell Bank will undergo comprehensive viral and adventitious agent testing by an accredited third-party lab. According to Avaí Bio, tests will confirm absence of pathogenic viruses, bacteria, mycoplasma, fungi, and yeast to meet regulatory expectations, including those of the FDA.

What is the next manufacturing step after Avaí Bio’s Klotho Master Cell Bank testing?

After successful testing, Avaí Bio plans to create a Working Cell Bank from the Master Cell Bank. According to Avaí Bio, these α-Klotho overexpressing cells will be used to produce the final Cell-in-a-Box® encapsulated clinical product for patient application.

What is Klothonova and how is it related to Avaí Bio (AVAI) and Austrianova?

Klothonova is a Nevada-based joint venture equally owned by Avaí Bio and Austrianova’s affiliate SG Austria. According to Avaí Bio, Klothonova focuses on sustainable production of α-Klotho via encapsulated cell-based therapies for aging, kidney disease, neurodegenerative, and vascular conditions.

How does Avaí Bio’s α-Klotho program target aging and age-related diseases for AVAI investors?

Avaí Bio aims to restore declining α-Klotho, a protein linked with healthy aging, using encapsulated cells. According to Avaí Bio, the approach is intended for general aging and age-related conditions, including kidney disease, neurodegenerative disorders, and vascular diseases.