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KUALA LUMPUR/SINGAPORE - BioNexus Gene Lab Corp. (NASDAQ:BGLC) announced Wednesday it has entered into definitive agreements with Fidelion Diagnostics and Tongshu Biotechnology to commercialize VitaGuard, a liquid biopsy platform for minimal residual disease (MRD) testing. The micro-cap company, with a market capitalization of just $9.25 million, has seen its stock price surge 84% year-to-date despite its volatile trading pattern.
Under the agreements, BioNexus will receive shares equal to at least 15% of Fidelion's fully diluted share capital, while Fidelion will receive newly issued, restricted BioNexus shares equal to 19.9% of BGLC's pre-money outstanding shares in a private transaction.
The collaboration includes an exclusive licensing agreement granting BioNexus commercialization rights across the Association of Southeast Asian Nations (ASEAN) region, with initial focus on Singapore and Malaysia.
According to the press release, the VitaGuard platform can detect circulating tumor DNA down to 0.02% variant allele frequency and requires no tissue sample from the tumor, allowing for less invasive cancer monitoring.
"Moving from agreements to execution marks the next growth chapter for BGLC," said Sam Tan, Chief Executive Officer of both BioNexus and Fidelion, in the statement.
The companies stated that the platform aims to make MRD testing more accessible in Southeast Asia, similar to how sub-$1,000 genome sequencing made genetic testing more widely available.
Dr. Yan Linghua, CEO of Tongshu Gene and Director of Fidelion, noted that the partnership unites Tongshu's research capabilities with Fidelion's product development and BioNexus's planned commercialization efforts.
The transaction is expected to complete following satisfaction of remaining conditions within the specified period. The collaboration also contemplates data collection for potential AI and companion-diagnostic programs, subject to applicable laws and approvals.
BioNexus Gene Lab Corp. is focused on advancing precision diagnostics throughout Southeast Asia, while Singapore-based Fidelion Diagnostics commercializes the VitaGuard platform outside China. Tongshu Gene, headquartered in Wuxi, China, developed the original technology.
In other recent news, BioNexus Gene Lab Corp. has announced significant developments impacting its business operations. The company has entered strategic agreements with Fidelion Diagnostics to commercialize the VitaGuard platform for minimal residual disease testing in Southeast Asia. As part of this agreement, BioNexus will acquire Fidelion shares amounting to at least 15% of Fidelion's fully diluted share capital, while Fidelion will receive 19.9% of BioNexus's pre-money outstanding shares. Additionally, BioNexus has filed a registration statement with the U.S. Securities and Exchange Commission to register up to $100 million of securities for potential future offerings. This includes an at-the-market program established with Maxim Group LLC, allowing the sale of up to $20 million of common stock. Furthermore, BioNexus is in talks for a strategic partnership with BirchBioMed Inc., a Canadian biopharmaceutical company. This partnership involves BioNexus leading a $10 million financing round for BirchBioMed to help commercialize its FS2 topical platform in Southeast Asia. These recent developments indicate BioNexus's strategic focus on expanding its market presence and financial capabilities.
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