10-Q: NU-MED PLUS Reports Q3 Loss, Cites Going Concern Risk

NU-MED PLUS, an early-stage medical device company, reported a net loss for Q3 2025 and expressed substantial doubt about its ability to continue as a going concern without significant new capital.

Summary

• Reported a net loss of $11,966 for the three months ended September 30, 2025, an improvement from $18,677 in the same period of 2024.
• For the nine months ended September 30, 2025, the net loss was $43,564, down from $57,790 in 2024.
• The company has no revenue and has suspended product development due to lack of capital.
• Current assets are $5,048, with cash of $1,948, against total liabilities of $263,708, resulting in a working capital deficiency of $258,660.
• Management has expressed substantial doubt about the company's ability to continue as a going concern, as current funds are insufficient to execute its business plan.
• An estimated $1,200,000 in additional financing is required for the next twelve months ($300,000 for overhead and $900,000 for product development).
• Disclosure controls and procedures were deemed not effective as of September 30, 2025.

Sentiment

Score: 2

Explanation: The company faces severe financial distress, with insufficient cash, no revenue, suspended product development, and a going concern warning. While net losses decreased, this is largely due to reduced spending, not improved operations. The ineffective disclosure controls add to the negative sentiment.

Positives

• Net loss decreased for both the three-month ($11,966 vs $18,677) and nine-month ($43,564 vs $57,790) periods ended September 30, 2025, compared to the prior year.
• Operating expenses decreased for both the three-month ($10,075 vs $17,417) and nine-month ($39,194 vs $54,037) periods ended September 30, 2025, compared to the prior year, primarily due to reduced professional fees.
• The company has developed five distinct nitric oxide delivery products and a research unit, demonstrating technological progress despite funding challenges.
• Management believes there is ample market opportunity for a lower-cost nitric oxide delivery system compared to existing single-source options like Inomax.

Negatives

• The company has no revenue and does not anticipate any for the foreseeable future.
• Product development has been suspended due to a lack of capital infusion.
• Current cash balance is critically low at $1,948 as of September 30, 2025.
• Total liabilities significantly exceed total assets ($263,708 vs $5,048), resulting in a substantial working capital deficiency of $258,660.
• Management has expressed substantial doubt about the company's ability to continue as a going concern.
• The company is currently funded only through November 30, 2025.
• An estimated $1,200,000 in additional financing is required for the next twelve months, with no assurance of obtaining it at acceptable rates.
• Disclosure controls and procedures were concluded to be not effective as of September 30, 2025.
• Net cash used in operating activities significantly increased for the nine months ended September 30, 2025 ($12,925) compared to the same period in 2024 ($2,765).
• Reliance on related party loans for funding, including a new $12,500 note to an entity owned by the CEO and an $87,500 note to an entity owned by the CFO (partially converted from accounts payable).

Risks

• Substantial doubt about the company's ability to continue as a going concern due to insufficient funds.
• Inability to obtain additional funding through equity capital or shareholder loans could prevent the execution of the business plan and continued viability.
• Reliance on a small group of investors for funding, with the risk that they may become unable or unwilling to provide additional capital.
• Uncertainties relating to general economic and business conditions, industry trends, and changes in demand for products and services.
• Unanticipated delays in the development, market acceptance, or installation of products and services.
• Changes in government regulations, particularly regarding FDA approval for medical devices.
• Availability of management and other key personnel.
• Availability, terms, and deployment of capital.
• Relationships with third-party equipment suppliers.
• Worldwide political stability and economic growth.
• The long and expensive FDA approval process, with no assurance of obtaining approval for products.
• Inability to estimate the full costs or timing to bring proposed products to market.
• High costs associated with medical device testing and potential product refinement/modification.
• Cybersecurity threats, despite implemented measures, cannot be entirely eliminated, and undetected incidents may occur.

Future Outlook

The company anticipates no revenue for the foreseeable future as its products are still in the development stage. Product development has been suspended until a capital infusion is received. Management plans to seek $1,200,000 in additional financing over the next twelve months to cover overhead and resume product development, including efforts to secure funding for FDA approval of its hospital unit. There is no assurance that this funding will be obtained or that products will reach commercialization.

Management Comments

• In the opinion of management, all adjustments (which include only normal recurring accruals) necessary to present fairly the financial position and results of operations for the periods presented have been made.
• The results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025.
• While the Company is an early-stage company with no revenue, at the time we begin to generate revenue the Company will recognize such revenue in conformity with the guidelines set forth by ASC 606.
• The Company acknowledges that the funds on hand as of September 30, 2025, will not be sufficient to enable it to execute its business plan and funding through the sale of equity capital and short term related party and other shareholder loans in order to meet the planned expenditures for development, operations, and administrative cost over the next 12 months will be required.
• If plans to obtain further financing prove to be insufficient to fund operations, continued viability could be at risk. These factors raise substantial doubt about the Company's ability to continue as a going concern.
• 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.
• We believe, 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 anticipates that selling our units earlier into the market as laboratory equipment or to international groups will pave the way for sales of our medical delivery devices, but any financial contributions from intellectual property licenses and sales and other non-medical sales will not be adequate to fund the substantial costs of the FDA approval process for human medical uses.
• Without additional capital, we will not be able to stay in business and move our business plan forward.
• We do not anticipate any revenue for the foreseeable future as our products are still in the development stage.
• Our management does not expect that our disclosure controls and procedures will prevent all errors and all fraud.
• Based on that evaluation, as of September 30, 2025, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SECs rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

Industry Context

NU-MED PLUS operates in the medical device field, specifically focusing on nitric oxide delivery systems. The current FDA-approved use for inhaled nitric oxide (INO) is limited to treating hypoxia in premature infants. However, there is ongoing research into broader applications for nitric oxide in various diseases, including COPD, infections, and wound healing. The company aims to capitalize on this expanding potential by developing a new, cost-effective method to generate and deliver nitric oxide, challenging the existing single-source market dominated by products like Inomax. The high cost and limited accessibility of current INO delivery systems present an opportunity for NU-MED's proposed on-site generation technology, if it can overcome significant development and regulatory hurdles.

Comparison to Industry Standards

• The company's financial position, with minimal cash ($1,948) and a significant working capital deficiency ($258,660), is far below industry standards for a company aiming to develop and commercialize medical devices, which typically require substantial capital for R&D, clinical trials, and regulatory approvals.
• Unlike established medical device companies that generate significant revenue, NU-MED PLUS has no revenue, placing it in a pre-commercial, early-stage development phase, which is inherently high-risk and capital-intensive.
• The suspension of product development due to lack of funding is a critical deviation from the continuous R&D investment seen in successful medical device firms.
• The reliance on related-party loans for operational funding, rather than institutional investment or revenue, indicates a lack of access to conventional financing, which is common for distressed or very early-stage ventures but not sustainable for long-term growth in the medical device sector.
• The conclusion that disclosure controls and procedures were not effective is a significant governance issue, contrasting sharply with the robust internal controls expected of publicly traded companies, especially those in regulated industries.

Corporate Governance

Legal Proceedings

• None.

Related Party Transactions

• A $100,000 note payable to YourSpace America, Inc. (YSA), where William Hayde (CEO) also serves as Chairman of the Board.
• On August 15, 2025, a $12,500 note payable was issued to Interim Opportunity Fund LLC, an entity owned by William Hayde (CEO).
• On August 15, 2025, an $87,500 note payable was issued to Convergence LLC, an entity owned by Keith Merrell (CFO), of which $85,682 was converted from accounts payable to related party, and $1,818 was new cash.
• Office space and laboratory space are currently provided by officers at no charge.
• Employment agreements for Mr. Hayde and Mr. Merrell provide for no compensation until a major funding event.

Stakeholder Impact

• Shareholders: Face significant dilution risk from potential equity raises, substantial doubt about the company's going concern, and a lack of near-term revenue or product commercialization. The stock is highly speculative.
• Employees: Future employment and compensation are contingent on securing major funding, as current employment agreements for the CEO and CFO provide for no compensation until a major funding event.
• Creditors: Face high risk due to the company's weak financial position, going concern warning, and reliance on related-party loans.
• Customers (potential): Product development is suspended, meaning no new products will reach the market in the foreseeable future, delaying potential benefits from NU-MED's nitric oxide technologies.
• Suppliers: May face payment delays or non-payment given the company's liquidity issues and reliance on external funding.

Next Steps

• Obtain approximately $1,200,000 in additional financing for the next twelve months.
• Secure funding to resume product development, specifically for the nitric oxide generating compound formulation and delivery systems.
• Work towards submitting the hospital unit for FDA approval.
• Potentially sell research units or to international groups to pave the way for medical device sales, though this will not fund FDA approval.
• Address the ineffectiveness of disclosure controls and procedures.

Key Dates

Recommendation

The company is in severe financial distress, explicitly stating "substantial doubt about the Company's ability to continue as a going concern." Product development is suspended, there is no revenue, and cash on hand is minimal. The company requires $1.2 million in additional funding within 12 months with no assurance of obtaining it. Furthermore, disclosure controls were deemed ineffective. These factors indicate extreme operational and financial risk, making the stock a strong sell for any investor.

Keywords

NU-MED PLUS, Medical Device, Nitric Oxide, SEC Filing, Form 10-Q, Quarterly Report, Financial Results, Going Concern, Capital Raise, FDA Approval, Product Development, Early Stage Company, Biomedical Technology, Healthcare Innovation, Financial Reporting, Disclosure Controls