BioNexus Gene Lab Corp. Completes Strategic Investment in Fidelion Diagnostics; Secures 15% Equity Stake in Global AI-Oncology Platform and Exclusive Southeast Asian Rights for VitaGuard™

Rhea-AI Summary

BioNexus Gene Lab Corp (NASDAQ: BGLC) completed a strategic transaction with Fidelion Diagnostics and Tongshu Biotechnology on Dec 3, 2025. BGLC acquired a 15% equity stake in Fidelion via a non‑cash share swap and secured exclusive, perpetual commercial rights to the VitaGuard™ Tumor‑Naïve MRD liquid biopsy platform across all ASEAN markets.

The deal pairs a commercial asset (ASEAN manufacturing, marketing, distribution) with an investment asset (equity exposure to Fidelion). The license fee is payable over 24 monthly installments. Fidelion will hold approximately 16.6% of BGLC, aligning mutual interests and enabling joint regional studies, regulatory engagement, and market rollout.

Positive

• 15% equity stake in Fidelion Diagnostics acquired via share swap
• Exclusive, perpetual ASEAN rights to VitaGuard™ for manufacture, marketing, distribution
• License fee structured as 24 monthly installments to preserve cash and limit upfront outflow

Negative

• Fidelion will hold approximately 16.6% of BGLC, creating cross‑ownership concentration
• Contractual 24‑month license payments represent committed cash outflows during rollout

Insights

Strategic M&A Analyst

BGLC completed a non‑cash acquisition of a 15% stake in Fidelion and secured exclusive, perpetual ASEAN rights to VitaGuard™.

BioNexus Gene Lab Corp. now holds a 15% equity position in Fidelion Diagnostics via a share swap while Fidelion owns approximately 16.6% of BGLC, aligning cross‑ownership interests. The deal grants BGLC exclusive commercial, manufacturing and distribution rights for the VitaGuard™ tumor‑naïve MRD liquid biopsy across all ASEAN markets and stages license payments over 24 months, preserving cash and limiting dilution.

The business mechanism combines a near‑term commercial asset with a financial investment asset: exclusive ASEAN rights give direct control of market entry and sales execution, while the equity stake gives exposure to Fidelion’s planned international financing or listing events expressly referenced as options including Nasdaq/NYSE. Key dependencies include successful regulatory engagement, completion of regional studies, and the pace of commercial mobilization across Malaysia, Singapore, Indonesia and Thailand, all of which the companies commit to collaborate on.

Concrete items to watch are the roll‑out milestones for VitaGuard™ across ASEAN, timing and structure of any Fidelion financing or "Qualified Financing Event" (including any Nasdaq/NYSE listing options), and the cashflow schedule tied to the 24 months license payments that supports inventory build and sales expansion. Short‑term focus should be on regulatory clearances and distributor agreements; medium‑term triggers include Fidelion financing milestones and initial commercial revenue recognition.

KUALA LUMPUR, Malaysia, Dec. 03, 2025 (GLOBE NEWSWIRE) -- BioNexus Gene Lab Corp. (NASDAQ: BGLC) ("BGLC" or the "Company"), a biotechnology company advancing precision diagnostics and gene-based technologies, today announced the formal completion of its strategic transaction with Fidelion Diagnostics Pte. Ltd. ("Fidelion") and Tongshu Biotechnology.

With the closing of the agreements, BGLC has become a strategic shareholder in Fidelion Diagnostics and secured exclusive commercial rights for the VitaGuard™ Tumor-Naïve Minimal Residual Disease (MRD) liquid biopsy platform across Southeast Asia (ASEAN) — positioning the Company for long-term growth as precision oncology adoption accelerates across the region.

Strategic Acquisition: 15% Equity Stake in Fidelion Diagnostics

BGLC has acquired a 15% equity position in Fidelion Diagnostics, the company that holds the exclusive global commercial rights (excluding Greater China) to the VitaGuard™ Tumor-Naïve AI-oncology platform. This investment provides BGLC shareholders with direct participation in Fidelion’s international expansion and future capital markets trajectory, including potential private financing rounds or a future “Qualified Financing Event,” which the agreements specifically include listing on Nasdaq or NYSE as options.

Exclusive Southeast Asian Commercial Rights

Simultaneously, BGLC has obtained exclusive, perpetual rights to manufacture, market, and distribute VitaGuard™ across all ASEAN markets, solidifying the Company as the sole provider of this advanced liquid biopsy technology in one of the world’s fastest-growing oncology regions.

Southeast Asia’s healthcare landscape is rapidly modernizing, with increasing demand for precision diagnostics and non-invasive tools for cancer management. The VitaGuard™ platform positions BGLC to capture early-mover advantage in this expanding market.

Capital-Efficient Deal Structure

The transaction was structured to maximize balance-sheet strength and minimize dilution:

• Equity Stake (Share Swap): Acquired through a non-cash, share exchange, aligning long-term interests between BGLC and Fidelion.
• Commercial License: The license fee is payable over 24 monthly installments, enabling BGLC to match outflows to expected commercial inflows.
  
  

This structure allows BGLC to accelerate market entry, build inventory, and expand regional sales functions while preserving shareholder value.

A “Dual-Asset” Value Creation Model

The completion of this transaction establishes a hybrid value model that is uncommon among micro-cap biotechnology companies:

1. A Commercial Asset

Through exclusive ASEAN rights, BGLC now controls a high-margin, high-growth cancer diagnostics franchise and has mobilized a commercial task force to engage major hospital networks and distributors across Malaysia, Singapore, Indonesia, and Thailand.

2. An Investment Asset

With a 15% equity stake in Fidelion, BGLC gains exposure to the global growth of Fidelion’s AI-driven oncology platform. This equity stake provides structured visibility into Fidelion’s pathway toward future financing milestones or potential liquidity events.

This combined model ensures that BGLC benefits both from immediate commercial activity and long-term enterprise value creation.

Management Commentary

“This partnership fundamentally elevates BGLC’s strategic position,” said Sam Tan, CEO of BioNexus Gene Lab Corp. “We are not only securing the engine for commercial growth in Southeast Asia; we are also now aligned as a strategic shareholder in a global AI-oncology platform. This structure gives our shareholders two distinct value levers — regional commercial expansion and exposure to Fidelion’s international growth and capital-market ambitions.”

Mr. Tan added, “We intentionally structured this transaction to preserve our financial strength and avoid unnecessary dilution. As the global precision oncology landscape shifts toward AI-enabled technologies, this partnership positions BGLC at the center of that transformation.”

Transaction Structure

• Share Swap: BGLC now owns 15% of the issued and outstanding stock of Fidelion Diagnostics while Fidelion holds approximately 16.6% of the issued and outstanding stock of BGLC, which strongly aligns our mutual interests.
• Exclusive License: The ASEAN commercial license is secured for BGLC through the Exclusive Licensing Agreement.
• Operational Mobilization: BGLC and Fidelion will collaborate on regional studies, regulatory engagement, and the introduction of next-generation oncology solutions to the Southeast Asian market.
  
  

About VitaGuard™

VitaGuard™ is a next-generation, AI-enabled platform for tumor-naïve minimal residual disease (MRD) monitoring. Designed as a high-efficiency, high-fidelity liquid biopsy system, VitaGuard™ enables clinicians to detect early signs of cancer recurrence and support precision-treatment decision making.

About BioNexus Gene Lab Corp.

BioNexus Gene Lab Corp. (NASDAQ: BGLC) is a biotechnology company advancing precision diagnostics and gene-based technologies. The Company is building a platform spanning precision medicine, biologics manufacturing, and AI-integrated healthcare solutions, targeting markets in Asia and the United States.
For more information, please visit www.bionexusgenelab.com.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by terminology such as "may," "should," "could," "would," "will," "expect," "anticipate," "intend," "plan," "believe," "estimate," "continue," "potential," and similar expressions. Forward-looking statements in this press release include, without limitation, statements regarding: (i) the commercial viability and market acceptance of the VitaGuard™ system in Southeast Asia; (ii) the potential value and future liquidity of the Company’s equity interest in Fidelion Diagnostics, including the likelihood of any future "Qualified Financing Event" or public listing; (iii) the Company’s ability to successfully integrate the new license into its existing operations and meet financial obligations; and (iv) the projected growth of the international MRD testing markets.

These forward-looking statements are based on a number of assumptions, including that: (a) Fidelion Diagnostics will successfully execute its business plan and technology roadmap outside of Greater China; (b) regulatory approvals for VitaGuard™ in ASEAN jurisdictions will be obtained in a timely manner; and (c) market demand for liquid biopsy testing will continue to grow as anticipated. Actual results could differ materially from those anticipated due to risks and uncertainties, including, among others: the risk that Fidelion may not achieve a liquidity event or IPO; the highly competitive nature of the diagnostics industry; and the need for additional BGLC capital to support commercialization. Many of these risks are described in the Company's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BGLC undertakes no obligation to publicly update or revise any forward-looking statements.

Investor Relations

BioNexus Gene Lab Corp.

Email: IR@BIONEXUSGENELAB.COM

FAQ

What did BioNexus (BGLC) announce on Dec 3, 2025 regarding Fidelion Diagnostics?

BGLC acquired a 15% equity stake in Fidelion and secured exclusive ASEAN commercial rights to the VitaGuard™ MRD platform.

How was BGLC's 15% stake in Fidelion funded for BGLC (NASDAQ: BGLC)?

The 15% stake was acquired through a non‑cash share swap, aligning the companies without immediate cash dilution.

What are the payment terms for the VitaGuard™ ASEAN license secured by BGLC?

The commercial license fee is payable over 24 monthly installments to match expected commercial inflows.

What exclusive commercial scope did BGLC obtain for VitaGuard™ (BGLC)?

BGLC obtained exclusive, perpetual rights to manufacture, market, and distribute VitaGuard™ across all ASEAN countries.

Does the transaction create mutual ownership between BGLC and Fidelion?

Yes. BGLC owns 15% of Fidelion, while Fidelion holds approximately 16.6% of BGLC.

What immediate commercial actions will BGLC take after the Fidelion transaction?

BGLC plans regional mobilization including commercial task force engagement with hospitals and distributors and collaboration on regional studies and regulatory engagement.