Company: BGLC
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001477932-25-002725
Chunk: 462

Company: BioNexus Gene Lab Corp
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 462
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 MRNA Scientific is unable to manage its anticipated growth effectively, MRNA Scientific’s future business could be harmed.

MRNA Scientific’s financial prospects depend substantially upon the successful commercialization of the Company’s services and products in the future, which may fail or experience significant delays.

MRNA Scientific’s future success depends upon MRNA Scientific’s ability to continuously develop technologies and successfully market its existing cancer genetic offerings to customers within Malaysia and expand overseas. MRNA Scientific’s ability to generate significant revenue in the next several years will depend primarily on the successes of each key stage of its business, including pre-clinical research and development, clinical trials, regulatory approval, manufacture, marketing and commercialization of its services and products, which is subject to significant uncertainty. MRNA Scientific’s ability to generate sales revenue from its products and services and its future profitability depends on several factors, including its ability to:

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 ·obtain regulatory approvals and marketing authorizations for MRNA Scientific’s services and products;    ·obtain market acceptance by patients, hospitals, clinicians, biopharmaceutical companies and others in the medical community;    ·establish sufficient testing capacity and commercial capabilities, either by expanding MRNA Scientific’s current facility or making arrangements with third parties;    ·develop and maintain MRNA Scientific’s sales network to launch and commercialize its new cancer genomic testing services and products;    ·set appropriate and favorable prices for MRNA Scientific’s genomic testing services and products and obtaining adequate reimbursement from third-party payers;    ·maintain commercially viable supply relationships with third parties and maintaining sufficient research and development capabilities and infrastructure;    ·address any competing technological and market developments; and    ·maintain, protect, and expand MRNA Scientific’s portfolio of intellectual property rights including trade secrets and know-how.

The marketing, sale and use of MRNA Scientific’s products and services could result in substantial damages arising from products or service liability or professional liability claims, that exceed MRNA Scientific’s resources.

Due to the nature of MRNA Scientific’s business, it may face claims for products or service liability. These claims may arise from the inaccurate or erroneous diagnosis of patient information or the mix-up of patient information whereby a patient receives the wrong diagnostic information. While the company feels confident in its quality control measures to ensure the safeguard of patient and client information, it cannot provide assurances that products or service liability claims will arise in the future.

Moreover, litigation or adverse publicity resulting from these allegations could materially and adversely affect MRNA Scientific’s