10-K: Nu-Med Plus, Inc. Files Annual Report on Form 10-K

Nu-Med Plus, Inc. files its annual report on Form 10-K for the fiscal year ended December 31, 2025, detailing its ongoing development of nitric oxide delivery systems and its precarious financial situation.

Summary

• Nu-Med Plus, Inc. has filed its annual report for the fiscal year ended December 31, 2025.
• The company is focused on developing medical devices for nitric oxide delivery, but product development has been suspended due to a lack of capital.
• Nu-Med Plus, Inc. is classified as an emerging growth company and a smaller reporting company, utilizing reduced disclosure requirements.
• The company reported no revenue for the fiscal years 2025 and 2024, with net losses of $56,182 and $68,345, respectively.
• As of December 31, 2025, the company had total assets of $7,911 and total liabilities of $279,189, with cash on hand of $661.
• The company's auditors have expressed substantial doubt about its ability to continue as a going concern.
• Management is seeking additional financing and exploring a merger partner to fund product development and operations.
• The company has two approved patents and one pending patent related to its nitric oxide systems.

Sentiment

Score: 2

Explanation: StockSavvy.ai views this filing as highly negative due to the company's severe undercapitalization, lack of revenue, ongoing losses, and the auditor's going concern warning, despite some progress in patent filings.

Positives

• The company has developed a proprietary formulation for nitric oxide generation and several prototype delivery systems.
• Two patents have been approved, and one is pending, related to nitric oxide systems, indicating progress in intellectual property development.
• The company's executive offices and laboratory space are currently provided at no cost.
• Operating expenses decreased in 2025 compared to 2024, reflecting cost management efforts.

Negatives

• The company has no revenue and has incurred net losses since inception, with an accumulated deficit of $9,949,514 as of December 31, 2025.
• The company has minimal cash on hand ($661 as of December 31, 2025) and is dependent on shareholder loans and future financing to continue operations.
• Product development has been suspended due to a lack of capital, and there is no assurance that necessary funding will be obtained.
• The company's auditors have issued a going concern warning, indicating substantial doubt about its ability to continue as a going concern.
• The company has material weaknesses in its internal controls over financial reporting due to a limited team and lack of separation of duties.
• Management and directors have not received any compensation, reflecting the company's severe financial constraints.
• The company has no outstanding equity awards or stock options, and no stock option grants were made in the last two fiscal years.

Risks

• The company is undercapitalized and relies on raising additional capital to stay in business, with no assurance of obtaining such financing.
• The company is in the product development phase, and its products are years away from potential sales, with no guaranteed market.
• The medical device industry is highly competitive and subject to extensive regulations, making it difficult and expensive to bring new products to market.
• Management lacks extensive experience in developing and bringing medical products to market.
• The company is subject to environmental regulations related to the handling and disposal of nitric oxide, which could increase costs.
• Failure to obtain or maintain regulatory approvals (e.g., FDA) could materially adversely affect the business.
• The company may be subject to product liability claims if its products cause harm.
• The company's auditors have indicated substantial doubt about its ability to continue as a going concern, affecting its ability to raise capital.
• The company has material weaknesses in internal controls, increasing the risk of reporting inaccuracies.
• The company does not intend to pay dividends in the foreseeable future.
• A small number of stockholders and managers have significant influence over the company, potentially limiting other stockholders' voice.
• The company may issue more stock without shareholder input, diluting existing shareholders' ownership.
• The departure of key personnel could adversely affect the company's ability to develop its products.
• Reimbursement from third-party payers for future products is uncertain and could limit commercial opportunities.
• The company has no insurance for environmental liability or toxic tort claims.

Future Outlook

The company anticipates operating losses for the foreseeable future and requires significant additional capital to fund product development, testing, FDA applications, and general operations. Management is actively seeking financing and exploring merger opportunities. Without sufficient capital, the company's ability to continue operations is at risk.

Management Comments

• Management believes that with the further refinement of our formulation, we can make and filter medical grade nitric oxide gas with minimal amounts of nitrogen dioxide, and that this process can produce medical grade nitric oxide gas in ample quantities for any current or prospective use and hopefully at a price less than that of all currently available technologies.
• Management believes, given this structure, there is ample room for a competitive response from NU-MED using on site generated nitric oxide at a lower cost to penetrate the market.
• Management believes it may take some time before a commercial product is able to be marketed and will have to rely on outside funding to support operations through not only the development and testing phases, but the licensing phase and initial marketing cycles.
• Management believes, with the costs to develop new technology and receive FDA regulatory approval for those devices, it is important to divide the capital needs into phases to be able to track development progress and anticipate capital needs better.
• Management believes that we will continue to be reliant on loans and stock sales to stay in business.

Industry Context

StockSavvy.ai notes that Nu-Med Plus operates in the highly regulated and capital-intensive medical device sector, specifically focusing on nitric oxide delivery systems. The company faces significant competition from larger, well-established players with greater financial and technical resources. The path to FDA approval is lengthy and costly, and the company's current financial precariousness poses a substantial hurdle to commercialization.

Comparison to Industry Standards

• The company's financial situation, with minimal cash, no revenue, and significant accumulated deficit, is far below industry standards for companies seeking to commercialize medical devices.
• The reliance on shareholder loans and the going concern warning from auditors are critical deviations from typical industry financial health.
• Competitors like Mallinckrodt Inc. (with INOMAX) and GeNO LLC have already achieved FDA approvals for specific nitric oxide applications, setting a benchmark for regulatory success that Nu-Med Plus has yet to reach.
• The cost of developing a medical device, including testing and licensing, is substantial, and Nu-Med Plus's projected budget of $1,250,000 for the next year is likely insufficient compared to industry norms for bringing a product through FDA approval.

Corporate Governance

Legal Proceedings

• None reported.

Related Party Transactions

• Accounts payable to officers and directors totaled $941 as of December 31, 2025.
• Notes payable to officers totaled $112,500 as of December 31, 2025, representing funds provided for operating expenses.
• Employment agreements with William Hayde and Keith L. Merrell provide for no salary until a major funding event is finalized.

Stakeholder Impact

• Shareholders: High risk of investment loss due to the company's going concern status and potential for significant dilution from future capital raises. Lack of dividends is also a factor.
• Employees: With only two employees, the company's continued operation is precarious, impacting job security.
• Creditors: The company's liabilities ($279,189) significantly exceed its assets ($7,911), posing a risk to creditors.
• Management/Officers: Currently not receiving compensation, indicating severe financial constraints impacting their incentives and the company's ability to retain key personnel.

Next Steps

• Secure additional financing to fund operations and product development.
• Continue efforts to locate a merger partner.
• Finalize product development and testing for FDA submission.
• Pursue additional patent applications.
• Implement steps to correct material weaknesses in internal controls.

Key Dates

Recommendation

The company's severe financial distress, lack of revenue, ongoing losses, and the auditor's going concern warning present an extremely high risk to investors. Despite progress in patent filings, the path to commercialization is fraught with uncertainty and requires substantial capital that the company has no assurance of obtaining. The high probability of losing the entire investment makes it a sell.

Keywords

Nu-Med Plus, Form 10-K, Annual Report, Medical Device, Nitric Oxide, Product Development, FDA Approval, Capital Raise, Going Concern, Emerging Growth Company, Smaller Reporting Company, Financial Statements, Regulatory Approval