Company: BGLC
Filing Date: 2025-04-15
Form Type: 10-K
Source: 0001477932-25-002725
Chunk: 465

Company: BioNexus Gene Lab Corp
Filing Date: 2025-04-15
Form: 10-K
Item: Item 1A
Chunk 465
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 assurance that:

MRNA Scientific will develop any tests that meet its desired target product profile and address the relevant clinical need or commercial opportunity;

 ·any tests that MRNA Scientific develop will prove to be effective in clinical trials, platform validations, or otherwise;    ·MRNA Scientific will obtain necessary regulatory authorizations, in a timely manner or at all;    ·any tests that MRNA Scientific develop will be successfully marketed to and ordered by healthcare providers;    ·any tests that MRNA Scientific develop will be produced at an acceptable cost and with appropriate quality;    ·its current or future competitors will not introduce tests similar to ours that have superior performance, lower prices, or other characteristics that cause healthcare providers to recommend, and consumers to choose, such competitive tests over ours; or    ·third parties do not or will not hold patents in any key jurisdictions that would be infringed by its tests.

These and other factors beyond MRNA Scientific’s control could delay its launch of enhanced, improved, or new test and test candidates.

The research and development process in the biotechnology industry generally requires a significant amount of time from the research and design stage through commercialization. The launch of such new test requires the completion of certain clinical development and/or assay validations in the commercial laboratory. This process is conducted in various stages, and each stage presents the risk that MRNA Scientific will not achieve its goals and will not be able to complete clinical development for any planned test in a timely manner. Such development and/or validation failures could prevent or significantly delay its ability to obtain FDA clearance or approval as may be necessary or desired, obtain approval by entities that provide oversight over laboratory diagnostic tests in the localities MRNA Scientific operate in, or launch any of its planned tests and test candidates. At times, it may be necessary for us to abandon a product in which MRNA Scientific has invested substantial resources. Without the timely introduction of new test candidates and improvements or enhancements of its current tests, its tests may become obsolete over time and its competitors may develop tests that are more competitive, in which case its business, operating results, and financial condition will be harmed.

MRNA Scientific faces challenges from the evolving regulatory environment and increasing public awareness on privacy, personal data protection and cybersecurity. Actual or alleged failure to comply with privacy, cybersecurity and data protection-related laws and regulations could adversely affect MRNA Scientific’s business and reputation.

MRNA Scientific face risks inherent in handling large volumes of data and in protecting the security of such data, including cyber attacks. In particular,