BioNexus Gene Lab (BGLC) risk factors, FY2024 10-K

BioNexus Gene Lab's FY2024 10-K, filed Apr 15, 2025, lists 53 risk factors in 6 groups. There is no earlier 10-K to compare against, so the most company-specific risks are listed below.

Risk factors listed
536 groups
Section length
12k wordsItem 1A

BioNexus Gene Lab's biggest risks in the FY2024 10-K

  • MRNA Scientific relies heavily on genomic screening in Malaysia without clinical trials or product liability insurance.
  • Chemrex faces volatile raw material costs and cyclical demand across construction and medical sectors.
  • The company recently expanded its focus to explore business opportunities in the cryptocurrency industry.

The risks most specific to BioNexus Gene Lab

  • We are an early commercial-stage company and have a limited operating history, which may make it difficult to evaluate our current business and predict our future performance

    We are an early commercial-stage company with a limited operating history, making predictions about our future performance subject to significant uncertainty.

  • Our competitiveness and growth depend on our ability to fund our capital expenditures. We cannot assure you that it will be able to fund our capital expenditures at reasonable costs due to adverse macroeconomic conditions, our performance or other external factors

    We cannot assure you of funding our capital expenditures for MRNA Scientific and Chemrex at reasonable costs due to adverse macroeconomic conditions.

  • Recent business decisions regarding the Cryptocurrency Industry

    We have recently decided to explore business opportunities in the cryptocurrency market and are currently developing our strategies.

  • General Business and Industry Risks

    We may be adversely impacted by changes in laws and regulations, or in their application

    MRNA Scientific established its Malaysian laboratory through an invitation and a government grant of $1,250,000, and is currently not materially restricted by regulations.

  • General Business and Industry Risks

    Our lack of insurance could expose us to significant costs and business disruption

    We lack product liability or disruption insurance for our Malaysian and overseas operations due to high costs and difficulties in acquisition.

  • Risk Related to MRNA Scientific’s Business and Industry

    MRNA Scientific’s biomarkers have not undergone clinical trials

    MRNA Scientific has not conducted clinical trials on its biomarkers because there are no governmental regulations materially restricting our screening business in Malaysia.

  • Risk Related to MRNA Scientific’s Business and Industry

    MRNA Scientific’s success depends on their ability to improve and enhance its current tests and new test candidates, which is complex and costly, and the results are uncertain

    MRNA Scientific is collaborating with the National Heart Institute in Malaysia to identify genomic signatures in acute myocardial infarctions.

  • Risk Related to MRNA Scientific’s Business and Industry

    MRNA Scientific plans to expand its tests and services to multiple countries exposes us to risks associated with doing business outside of Malaysia. The expansion may not be successful, which could limit MRNA Scientific’s ability to grow its revenue, net income, and profitability

    MRNA Scientific plans to set up RNA screening lab operations in Indonesia, the Middle East, the USA, China, and Germany.

  • Risk Related to Chemrex’s Business and Industry

    We have oral contracts with suppliers and customers, which are generally terminable upon notice, and the termination of our relationships with suppliers and customers contracts could negatively affect our business

    We have oral contracts with suppliers and customers for our chemical distribution business, which are generally terminable upon notice.

All 53 risk factors

Headings as the filing states them, in filing order.

Other

  1. 01Proactive Risk Management and Mitigation Strategies
  2. 02We are an early commercial-stage company and have a limited operating history, which may make it difficult to evaluate our current business and predict our future performance
  3. 03Our competitiveness and growth depend on our ability to fund our capital expenditures. We cannot assure you that it will be able to fund our capital expenditures at reasonable costs due to adverse macroeconomic conditions, our performance or other external factors
  4. 04Our ability to collect its accounts receivable
  5. 05Our net losses may continue in the future
  6. 06Any additional capital we raise may not be available on satisfactory terms and may adversely affect stockholders’ holdings or rights
  7. 07Raising additional capital may lead to dilution of shareholdings by our existing shareholders, restrict our operations, and may further result in fair value loss, adversely affecting our financial results
  8. 08Recent business decisions regarding the Cryptocurrency Industry

General Business and Industry Risks

  1. 09Global economic conditions could materially adversely impact demand for our products and services
  2. 10Our risk management programs, processes, or procedures for identifying and addressing risks in MRNA Scientific’s business may not be adequate or effectively applied, and this may adversely impact its businesses
  3. 11We may be adversely impacted by changes in laws and regulations, or in their application
  4. 12Business disruptions could seriously harm our future revenue and financial condition and increase its costs and expenses
  5. 13Our lack of insurance could expose us to significant costs and business disruption
  6. 14Fluctuations in foreign currency exchange rates could have a material adverse effect on our financial results

Risk Related to MRNA Scientific’s Business and Industry

  1. 15Exponential growth in biotechnology
  2. 16MRNA Scientific’s inability to manage growth could harm its business
  3. 17MRNA 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
  4. 18The 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
  5. 19MRNA Scientific may face technology transfer challenges and expenses in adding new tests to its portfolio and in expanding its reach into new geographical areas
  6. 20MRNA Scientific’s biomarkers have not undergone clinical trials
  7. 21MRNA Scientific currently receives and expects to continue to receive a significant portion of its revenues from its genomic screening products, and if its efforts to further increase the use and adoption of these products fail, its business will be harmed
  8. 22MRNA Scientific’s success depends on their ability to improve and enhance its current tests and new test candidates, which is complex and costly, and the results are uncertain
  9. 23These and other factors beyond MRNA Scientific’s control could delay its launch of enhanced, improved, or new test and test candidates
  10. 24Any system failure or security breach or lapse that results in the release of user data could harm MRNA Scientific’s reputation and brand and, consequently, MRNA Scientific’s business, in addition to exposing us to potential legal liability
  11. 25MRNA Scientific’s software is highly complex and may contain undetected errors
  12. 26MRNA Scientific’s use of “open source” software could subject its proprietary software to general release, adversely affect its ability to sell its tests and subject the company to possible litigation
  13. 27MRNA Scientific may face competition from other biotechnology competitors and its operating results will suffer if MRNA Scientific fail to compete effectively
  14. 28In addition, smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. In addition, many universities and private and public research institutes may become active in MRNA Scientific’s target disease areas
  15. 29Cyber breaches, loss of data, and other disruptions could compromise sensitive information related to MRNA Scientific’s business or prevent us from accessing critical information and expose us to liability, which could adversely affect MRNA Scientific’s business and its reputation
  16. 30MRNA Scientific plans to expand its tests and services to multiple countries exposes us to risks associated with doing business outside of Malaysia. The expansion may not be successful, which could limit MRNA Scientific’s ability to grow its revenue, net income, and profitability

Risk Related to Chemrex’s Business and Industry

  1. 31The chemical raw material industry is cyclical and both recessions and prolonged periods of slow economic growth could have an adverse effect on Chemrex’s business
  2. 32Chemrex, as a reseller, relies on outside vendors to supply us with raw materials, including fibre reinforced plastics. Chemrex purchases most of its primary raw material, from numerous other sources located throughout Malaysia and internationally
  3. 33Disruptions in the supply of chemicals that we distribute or in the operations of our customers could adversely affect our business
  4. 34We have oral contracts with suppliers and customers, which are generally terminable upon notice, and the termination of our relationships with suppliers and customers contracts could negatively affect our business
  5. 35We may lose customers and suffer damage to our reputation if we are unable to meet customer demand for a particular product
  6. 36We may be exposed to product returns and product liability claims and latent defect liability claims

Risks Related to Our Operations

  1. 37Our officers and directors may in future have outside business activities. As a result, there may be potential conflicts of interest and negatively impact the amount of time they will be able to dedicate to the company
  2. 38We may not be able to attract and retain key senior management members and research and development personnel
  3. 39We may be unable to protect the company’s intellectual property adequately
  4. 40We may be subject to intellectual property claims, which are extremely costly to defend, could require us to pay significant damages and could limit the company’s ability to use certain technologies in the future

Risk related to Nasdaq compliance due to board changes

  1. 41We may be required to restate our financial statements or make material adjustments due to ongoing investigations into past governance failures at our Chemrex subsidiary
  2. 42Our internal controls over financial reporting may remain deficient due to legacy governance gaps and evolving compliance frameworks
  3. 43We may face shareholder rejection of unratified transactions
  4. 44We may pursue collaborations, in-licensing or out-license arrangements, joint ventures, strategic alliances, partnerships or other strategic investments or arrangements, which may fail to produce anticipated benefits and adversely affect the company’s operations
  5. 45partners, collaborators, or other parties may own or co-own intellectual property covering our services and products that results from our collaborations with them, and in such cases, we would not have the exclusive right to commercialize such intellectual property

Risks Related to Doing Business in the Southeast Asia Region

  1. 46Changes in policies in Malaysia and other Southeast Asian countries could have a significant impact upon the company’s ability to operate profitably in Malaysia and the Southeast Asia region
  2. 47Developments in the social, political, regulatory and economic environment in Malaysia may have a material adverse impact on us
  3. 48You may experience difficulties in effecting service of legal process, enforcing foreign judgments or bringing actions in Malaysia against the company or its management based on foreign laws, and the ability of U.S. authorities to bring actions in Malaysia may also be limited
  4. 49We are subject to foreign exchange control policies in Malaysia
  5. 50Volatility in our shares price may subject us to securities litigation
  6. 51We may never be able to pay dividends and are unlikely to do so
  7. 52Shareholders may be diluted significantly through our efforts to obtain financing and satisfy obligations through the issuance of securities
  8. 53We are a “smaller reporting company,” and we cannot be certain if the reduced disclosure requirements applicable to smaller reporting companies will make our common stock less attractive to investors

Other BioNexus Gene Lab 10-Ks

  • FY2025 10-K risk factors
    50 risks3 dropped4 reworded

    BioNexus dropped cryptocurrency exploration and Chemrex governance transaction risks while updating exposures to Malaysian regulation, economic cycles, and biotech competition.

    Filed Apr 14, 2026

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.