Bio Green Med Solution (BGMS) FY2025 10-K Risk Factors: 39 New, 46 Dropped

What the changes say

The company acquired Fitters Sdn.
Bhd., shifting its primary business from biotech clinical trials to manufacturing and trading fire safety equipment in Malaysia.

What changed since the prior 10-K

New

NewRisks Related to Our Business and Industry
The demand for our products is impacted by a number of factors outside of our control
Our newly acquired fire safety division, Fitters Sdn. Bhd., faces rapidly changing product demand and risk of obsolescence.
NewRisks Related to Our Business and Industry
Our performance is tied to customer demand for fire suppression equipment and materials, the decrease of which could adversely affect our performance
Our top four customers accounted for 55% of total sales in 2025, with our largest customer representing 36%.
NewRisks Related to Our Business and Industry
If any of our customers fail to pay us, our profit and cash flow may be affected as a result
Slow payment processes or customer defaults could negatively affect our working capital and operating cash flow.
NewRisks Related to Our Business and Industry
We are substantially dependent upon our senior management and key personnel
We depend heavily on senior management and key personnel without maintaining key man life insurance.
NewRisks Related to Our Business and Industry
We may not pay dividends
We cannot assure you that our board of directors will declare dividends even if we remain profitable.
NewRisks Related to Our Business and Industry
We do not carry business interruption insurance so we could incur unrecoverable losses if our business is interrupted
We do not carry business interruption or third-party liability insurance to cover losses from equipment failure or natural disasters.
NewRisks Related to Our Business and Industry
We may need to raise additional capital to grow our business and satisfy our anticipated future liquidity needs, and we may not be able to raise it on terms acceptable to us, or at all
We had cash on hand of $3.5 million as of December 31, 2025, and may need to raise additional capital.
NewRisks Related to Our Business and Industry
Raising capital in the future could cause dilution to our existing shareholders and may restrict our operations or require us to relinquish rights
Future capital raising through equity or debt could dilute existing shareholders or impose restrictive operational covenants.
NewRisks Related to Our Business and Industry
We are subject to risks from changes to trade policies, tariffs and import/export regulations by the U.S. and/or other foreign governments
International operations and export sales from Malaysia subject us to trade restrictions, tariffs, and import/export regulations.
NewRisks Related to Our Business and Industry
Our profitability could be negatively impacted by price and inventory risk related to our business, including commodity price exposure
Our realized margins depend on supply costs, making our profitability sensitive to commodity price fluctuations.
NewRisks Related to Our Business and Industry
Our industry is very competitive and some of our products are commodities
Low barriers to entry in the fire protection equipment distribution market expose us to intense competition.
NewRisks Related to Our Business and Industry
There is no assurance that our existing projects will not be delayed or terminated and there can also be no certainty that our order book will be continually maintained at such level in the future
Our fire services division depends on the sustainability of our order book and avoiding project delays or terminations in Malaysia.
NewRisks Related to Our Business and Industry
Risks from the improper conduct of, or use of our products by, employees, agents, government contractors, or collaborators could adversely affect our reputation as well as our business, financial condition and results of operations
NewRisks Related to Our Business and Industry
There is no guarantee that we will be able to continue purchasing products from our suppliers on a long-term basis
NewRisks Related to Our Business and Industry
Our business may be negatively affected by labor issues and higher labor costs
NewRisks Related to Our Business and Industry
We are subject to interest rate risks
NewRisks Related to Our Business and Industry
Unfavorable economic and market conditions could materially and adversely affect our business, results of operations and financial condition
NewRisks Related to Our Business and Industry
Global economic conditions could negatively affect our prospects for growth
NewRisks Related to Our Business and Industry
The markets in which we operate are highly competitive, and some of our competitors have greater financial and other resources than we do
NewRisks Related to Regulatory and Legal Matters
Our ability to market and sell our products and solutions is subject to existing government laws, regulations and standards
NewRisks Related to Regulatory and Legal Matters
Failure to comply with stringent and evolving fire safety regulations in Malaysia could negatively affect our prospects for growth and operating results
NewRisks Related to Regulatory and Legal Matters
Some of our products may be subject to government regulations pertaining to exportation, which may limit the markets in which we can sell some of our products
NewRisks Related to Regulatory and Legal Matters
We may be subject to product liability or warranty claims that could require us to make significant payments
NewRisks Related to Regulatory and Legal Matters
We may be the subject of litigation by customers, suppliers and other third parties in the future
NewRisks Related to Regulatory and Legal Matters
Claims of injuries or potential safety issues or quality concerns could be made against our various subsidiaries
NewRisks Related to Regulatory and Legal Matters
We are subject to risks related to our environmental, social and governance activities and disclosures
NewRisks Related to Regulatory and Legal Matters
We are subject to various U.S. and foreign tax laws and any changes in these laws related to the taxation of businesses and resolutions of tax disputes could adversely affect our results of operations
NewRisks Related to Our Business and Financial Condition
There is substantial doubt regarding our ability to continue as a going concern
NewRisks Related to Our Business and Financial Condition
Geopolitical and macroeconomic events and conditions could adversely affect our business, operating results, financial condition and cash flows
NewRisks Related to Inflation
Compliance with the United States securities laws and regulations is likely to make it more difficult and expensive for us to obtain directors’ and officers’ liability insurance and to attract and retain qualified members of our board of directors
NewRisks Related to Inflation
Our business could be adversely affected by significant movements in foreign currency exchange rates
NewRisks Related to Securities Regulations and Investment in Our Securities
We may not be able to facilitate our growth strategy by identifying or completing transactions with attractive acquisition candidates, which could limit our revenues and profitability
NewRisks Related to Securities Regulations and Investment in Our Securities
Businesses we acquire may have undisclosed liabilities
NewRisks Related to Securities Regulations and Investment in Our Securities
The market price of the Company’s common stock is expected to be volatile, and the market price of its common stock may drop
NewRisks Related to Securities Regulations and Investment in Our Securities
The Company will incur costs and demands upon management as a result of complying with the laws and regulations affecting public companies
NewRisks Related to Securities Regulations and Investment in Our Securities
The Company may experience adverse consequences because of required indemnification of officers and directors
NewRisks Related to Securities Regulations and Investment in Our Securities
Failure to compete successfully in our markets could adversely affect our business
NewRisks Related to Securities Regulations and Investment in Our Securities
Changes in our effective tax rates may adversely affect our financial results
NewRisks Related to Securities Regulations and Investment in Our Securities
Failure to comply with the U.S. Foreign Corrupt Practices Act or other applicable anti-corruption legislation could result in fines, criminal penalties and an adverse effect on our business

Dropped

Dropped
Risks Associated with Development and Commercialization of Our Drug Candidates
Risks associated with clinical trials and funding for drug candidates.
Dropped
If we experience delays or difficulties in the enrollment of research subjects in clinical trials, those clinical trials could take longer than expected to complete and our receipt of necessary regulatory approvals could be delayed or prevented
Delays or difficulties in enrolling research subjects in clinical trials.
Dropped
encounter difficulties in enrollment. If we experience delays in our clinical trials, the timeline for obtaining regulatory approval of our product candidate will most likely be delayed
Patient enrollment challenges affecting regulatory approval timelines.
Dropped
The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA or comparable foreign regulatory authorities
Preclinical testing and early clinical trial outcomes not predicting success.
Dropped
We are making use of biomarkers, which are not scientifically validated, and our reliance on biomarker data may thus cause us to direct our resources inefficiently
Reliance on scientifically unvalidated biomarkers for drug development.
Dropped
Our product candidate may cause undesirable side effects that could delay or prevent their marketing approval, limit their commercial potential, or result in significant negative consequences following marketing approval, if marketing approval is obtained
Undesirable side effects of drug candidate plogo.
Dropped
Any of these events could prevent us from achieving or maintaining market acceptance of plogo and could substantially increase the costs of its commercializing, if approved, and significantly impact our ability to successfully commercialize plogo and generate revenues
Failure to discover all possible adverse events in clinical trials.
Dropped
As we evolve from a company primarily involved in discovery and development to one also involved in the commercialization of drugs and devices, we may encounter difficulties in managing our growth and expanding our operations successfully
Difficulties in managing growth from discovery to commercialization.
Dropped
Our applications for regulatory approval could be delayed or denied due to problems with studies conducted before we licensed the rights to some of our product candidates
Regulatory approval delays due to pre-licensing studies by third parties.
Dropped
Even if we obtain regulatory approval for a product candidate, we will remain subject to ongoing regulatory requirements
Ongoing regulatory requirements post-approval.
Dropped
Obtaining and maintaining marketing approval of our current and future product candidates in one jurisdiction does not mean that we will be successful in obtaining marketing approval of our current and future therapeutic product candidates in other jurisdictions
Jurisdictional differences in obtaining marketing approval.
Dropped
Even if we successfully complete the clinical trials for Plogo, the product candidate may fail for other reasons
Other reasons for drug candidate failure after clinical trials.
Dropped
We face intense competition and our competitors may develop drugs that are less expensive, safer, or more effective than our drug candidates
Dropped
Our future product candidates, if any, for which we obtain approval may face competition sooner than anticipated
Dropped
The commercial success of our drug candidates depends upon their market acceptance among physicians, patients, healthcare providers and payors and the medical community
Dropped
other third-party payors; and
Dropped
The failure to attract and retain skilled personnel and key relationships could impair our drug development and commercialization efforts
Dropped
We may be exposed to product liability claims that cause us to incur substantial liabilities and we may be required to limit commercialization of our drugs that may damage our reputation and we may not be able to obtain adequate insurance
Dropped
If a supplier upon whom we rely fails to produce on a timely basis the finished goods in the volumes that we require or fails to meet quality standards and maintain necessary licensure from regulatory authorities, we may be unable to meet demand for our products, potentially resulting in lost revenues
Dropped
The commercialization of our products will be substantially dependent on our ability to develop effective sales and marketing capabilities
Dropped
We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product candidate and may have to limit its commercialization
Dropped
Healthcare legislative reform measures may have a material adverse effect on our business, financial condition or results of operations
Dropped
We may be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, and health information privacy and security laws. If we are unable to comply, or have not fully complied with such laws, we could face substantial penalties
Dropped
Defending against claims relating to improper handling, storage or disposal of hazardous chemical, radioactive or biological materials could be time consuming and expensive
Dropped
Our business and operations would suffer in the event of system failures
DroppedRisks Related to Our Business and Financial Condition
Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price
DroppedRisks Related to Our Business and Financial Condition
Our employees, independent contractors, principal investigators, contract research organizations, consultants or vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
DroppedRisks Related to Our Business and Financial Condition
We are at an early stage of development as a company and we do not have, and may never have, any products that generate significant revenues
DroppedRisks Related to Our Business and Financial Condition
We effected a 15:1 reverse stock split of our common stock on December 18, 2023 (the “Reverse Stock Split”), which enabled us to regain compliance with Nasdaq’s minimum bid price requirements
DroppedRisks Related to Our Business and Financial Condition
To the extent we elect to fund the development of a drug candidate or the commercialization of a drug at our expense, we will need substantial additional funding
DroppedRisks Related to Our Business and Financial Condition
Funding constraints may negatively impact our research and development, forcing us to delay our efforts to develop Plogo, which may prevent us from commercializing our product candidate as quickly as possible
DroppedRisks Related to Our Business and Financial Condition
We are exposed to risks related to foreign currency exchange rates
DroppedRisks Related to our Reliance on Third Parties
We rely, and expect to continue to rely, on third parties to conduct some aspects of our product formulation, research, preclinical, and clinical studies, and those third parties may not perform satisfactorily, including by failing to meet deadlines for the completion of such formulation, research or testing
DroppedRisks Related to our Reliance on Third Parties
We rely on third-party supply and manufacturing partners for drug supplies for our late-stage clinical activities and may do the same for any commercial supplies of our product candidate
DroppedRisks Related to our Reliance on Third Parties
An important element of our strategy for developing, manufacturing and commercializing our drug candidates is entering into strategic alliances with pharmaceutical companies, research institutions or other industry participants to advance our programs and enable us to maintain our financial and operational capacity
DroppedRisks Related to our Reliance on Third Parties
To the extent we are able to enter into strategic transactions, we will be exposed to risks related to those collaborations and alliances
DroppedRisks Related to our Intellectual Property
If we fail to enforce adequately or defend our intellectual property rights, our business may be harmed
DroppedRisks Related to our Intellectual Property
Our commercial success depends in large part on obtaining and maintaining patent and trade secret protection for our drug candidates, the methods used to manufacture those drug candidates and the methods for treating patients using those drug candidates
DroppedRisks Related to our Intellectual Property
If we do not obtain protection under the Hatch-Waxman Act and similar legislation outside of the United States by extending the patent terms and obtaining data exclusivity for our product candidate, our business may be materially harmed
DroppedRisks Related to our Intellectual Property
We may be subject to damages resulting from claims that our employees or we have wrongfully used or disclosed alleged trade secrets of former employers
DroppedRisks Related to our Intellectual Property
Confidentiality agreements with employees and others may not adequately prevent disclosure of our trade secrets and other proprietary information and may not adequately protect our intellectual property, which could limit our ability to compete
DroppedRisks Related to our Intellectual Property
Intellectual property rights of third parties may increase our costs or delay or prevent us from being able to commercialize our drug candidates
DroppedRisks Related to our Intellectual Property
We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights
DroppedRisks Related to our Intellectual Property
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
DroppedRisks Related to our Intellectual Property
The patent applications of pharmaceutical and biotechnology companies involve highly complex legal and factual questions, which, if determined adversely to us, could negatively impact our patent position
DroppedRisks Related to Securities Regulations and Investment in Our Securities
Fluctuations in our operating losses could adversely affect the price of our common stock

Reworded

81% rewrittenRisks Related to Inflation
If we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted
Retained the Nasdaq continued listing requirements risk regarding minimum stockholders equity of $2.5 million and $1.00 minimum bid price.
74% rewrittenRisks Related to Securities Regulations and Investment in Our Securities
If securities or industry analysts do not publish research or reports about us, if they change their recommendations regarding our stock adversely or if our operating results do not meet their expectations, our stock price and trading volume could decline
Removed extraneous sentences discussing acquisition transactions from the analyst coverage risk.
64% rewrittenRisks Related to Inflation
Our ability to use net operating loss and certain built-in losses to reduce future tax payments is limited by provisions of the Internal Revenue Code and may be subject to further limitation as a result of the transactions completed in connection with our initial public offering
Updated Section 382 net operating loss limitations language to explicitly include the recent acquisition of Fitters.
Was: Our ability to use net operating loss and tax credit carryforwards and certain built-in losses to reduce future tax payments is limited by provisions of the Internal Revenue Code and may be subject to further limitation as a result of the transactions completed in connection with our initial public offering
55% rewrittenRisks Related to Securities Regulations and Investment in Our Securities
An active trading market for our common stock has not developed and it may have a volatile public trading price, thus, purchasers of our common stock could incur substantial losses
Removed references specifically to biotechnology and life science stocks from the market volatility risk.
48% rewrittenRisks Related to Inflation
Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities
Removed specific listings of insured categories such as clinical trials and product liability from our insurance policy risk.
43% rewrittenRisks Related to Securities Regulations and Investment in Our Securities
Our common and preferred stock may experience extreme price and volume fluctuations, which could lead to costly securities-related litigation, including securities class action litigation or securities-related investigations, which could make an investment in us less appealing
Updated stock price fluctuation factors to include volatility in trading volumes and analyst research reports.
43% rewrittenRisks Related to Our Business and Industry
If we are unable to compete successfully in our marketplace, it will harm our business
Narrowed general competition risks specifically to the fire prevention products marketplace.
23% rewrittenRisks Related to Securities Regulations and Investment in Our Securities
If we automatically convert the convertible preferred stock, there is a substantial risk of fluctuation in the price of our common stock from the date we elect to automatically convert to the conversion date
Increased the preferred stock automatic conversion trigger price threshold from $888,300 to $213,192,000 per share.

All 61 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business and Industry

01The demand for our products is impacted by a number of factors outside of our controlNew
02Our performance is tied to customer demand for fire suppression equipment and materials, the decrease of which could adversely affect our performanceNew
03If any of our customers fail to pay us, our profit and cash flow may be affected as a resultNew
04We are substantially dependent upon our senior management and key personnelNew
05We may not pay dividendsNew
06We do not carry business interruption insurance so we could incur unrecoverable losses if our business is interruptedNew
07We may need to raise additional capital to grow our business and satisfy our anticipated future liquidity needs, and we may not be able to raise it on terms acceptable to us, or at allNew
08Raising capital in the future could cause dilution to our existing shareholders and may restrict our operations or require us to relinquish rightsNew
09We are subject to risks from changes to trade policies, tariffs and import/export regulations by the U.S. and/or other foreign governmentsNew
10Our profitability could be negatively impacted by price and inventory risk related to our business, including commodity price exposureNew
11Our industry is very competitive and some of our products are commoditiesNew
12There is no assurance that our existing projects will not be delayed or terminated and there can also be no certainty that our order book will be continually maintained at such level in the futureNew
13Risks from the improper conduct of, or use of our products by, employees, agents, government contractors, or collaborators could adversely affect our reputation as well as our business, financial condition and results of operationsNew
14There is no guarantee that we will be able to continue purchasing products from our suppliers on a long-term basisNew
15Our business may be negatively affected by labor issues and higher labor costsNew
16We are subject to interest rate risksNew
17Unfavorable economic and market conditions could materially and adversely affect our business, results of operations and financial conditionNew
18Global economic conditions could negatively affect our prospects for growthNew
19The markets in which we operate are highly competitive, and some of our competitors have greater financial and other resources than we doNew
20If we are unable to compete successfully in our marketplace, it will harm our business43% rewritten

Risks Related to Regulatory and Legal Matters

21Our ability to market and sell our products and solutions is subject to existing government laws, regulations and standardsNew
22Failure to comply with stringent and evolving fire safety regulations in Malaysia could negatively affect our prospects for growth and operating resultsNew
23Some of our products may be subject to government regulations pertaining to exportation, which may limit the markets in which we can sell some of our productsNew
24We may be subject to product liability or warranty claims that could require us to make significant paymentsNew
25We may be the subject of litigation by customers, suppliers and other third parties in the futureNew
26Claims of injuries or potential safety issues or quality concerns could be made against our various subsidiariesNew
27We are subject to risks related to our environmental, social and governance activities and disclosuresNew
28We are subject to various U.S. and foreign tax laws and any changes in these laws related to the taxation of businesses and resolutions of tax disputes could adversely affect our results of operationsNew

Risks Related to Our Business and Financial Condition

29There is substantial doubt regarding our ability to continue as a going concernNew
30Geopolitical and macroeconomic events and conditions could adversely affect our business, operating results, financial condition and cash flowsNew

Risks Related to Inflation

31Our ability to use net operating loss and certain built-in losses to reduce future tax payments is limited by provisions of the Internal Revenue Code and may be subject to further limitation as a result of the transactions completed in connection with our initial public offering64% rewritten
32If we fail to comply with the continued listing requirements of the Nasdaq Capital Market, our common stock may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted81% rewritten
33Compliance with the United States securities laws and regulations is likely to make it more difficult and expensive for us to obtain directors’ and officers’ liability insurance and to attract and retain qualified members of our board of directorsNew
34Our insurance policies are expensive and only protect us from some business risks, which will leave us exposed to significant uninsured liabilities48% rewritten
35Our business could be adversely affected by significant movements in foreign currency exchange ratesNew

Risks Related to Securities Regulations and Investment in Our Securities

36Failure to achieve and maintain internal controls in accordance with Sections 302 and 404 of the Sarbanes-Oxley Act of 2002 could have a material adverse effect on our business and stock price
37We incur increased costs and management resources as a result of being a public company, and we may fail to comply with public company obligations
38An active trading market for our common stock has not developed and it may have a volatile public trading price, thus, purchasers of our common stock could incur substantial losses55% rewritten
39If securities or industry analysts do not publish research or reports about us, if they change their recommendations regarding our stock adversely or if our operating results do not meet their expectations, our stock price and trading volume could decline74% rewritten
40We may not be able to facilitate our growth strategy by identifying or completing transactions with attractive acquisition candidates, which could limit our revenues and profitabilityNew
41Businesses we acquire may have undisclosed liabilitiesNew
42Anti-takeover provisions in our charter documents and provisions of Delaware law may make an acquisition more difficult and could result in the entrenchment of management
43As at December 31, 2025, we had 135,273 shares of 6% Convertible Exchangeable Preferred Stock and 264 shares of Series A Preferred Stock issued and outstanding
44In the event of an acquisition of our common stock, we cannot assure our common stockholders that we will be able to negotiate terms that would provide for a price equivalent to, or more favorable than, the price at which our shares of common stock may be trading at such time
45The market price of the Company’s common stock is expected to be volatile, and the market price of its common stock may dropNew
46The Company will incur costs and demands upon management as a result of complying with the laws and regulations affecting public companiesNew
47The Company may experience adverse consequences because of required indemnification of officers and directorsNew
48Our certificate of incorporation and bylaws and certain provisions of Delaware law may delay or prevent a change in our management and make it more difficult for a third-party to acquire us
49We may have limited ability to pay cash dividends on our preferred stock, and there is no assurance that future quarterly dividends will be declared
50Our common and preferred stock may experience extreme price and volume fluctuations, which could lead to costly securities-related litigation, including securities class action litigation or securities-related investigations, which could make an investment in us less appealing43% rewritten
51The future sale of our common and convertible preferred stock and future issuances of our common stock upon conversion of our preferred stock could negatively affect our stock price and cause dilution to existing holders of our common stock
52If we exchange the convertible preferred stock for debentures, the exchange will be taxable, but we will not provide any cash to pay any tax liability that any convertible preferred stockholder may incur
53If we automatically convert the convertible preferred stock, there is a substantial risk of fluctuation in the price of our common stock from the date we elect to automatically convert to the conversion date23% rewritten
54We do not intend to pay cash dividends on our common stock in the foreseeable future
55The number of shares of common stock which are registered, including the shares to be issued upon exercise of our outstanding warrants, is significant in relation to our currently outstanding common stock and could cause downward pressure on the market price for our common stock
56If persons engage in short sales of our common stock, including sales of shares to be issued upon exercise of our outstanding warrants, the price of our common stock may decline
57We are exposed to risks related to the marketable securities we may purchase
58Claims for indemnification by our directors and officers may reduce our available funds to satisfy successful stockholder claims against us and may reduce the amount of money available to us
59Failure to compete successfully in our markets could adversely affect our businessNew
60Changes in our effective tax rates may adversely affect our financial resultsNew
61Failure to comply with the U.S. Foreign Corrupt Practices Act or other applicable anti-corruption legislation could result in fines, criminal penalties and an adverse effect on our businessNew

Bio Green Med Solution (BGMS) risk factors, FY2025 10-K

What the changes say

What changed since the prior 10-K

All 61 risk factors

Other Bio Green Med Solution 10-Ks