UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
For the transition period from __________ to __________
Commission File Number
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) |
(Address of principal executive offices) | (Zip Code) |
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Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large Accelerated filer ☐ | Accelerated filer ☐ |
Smaller reporting company | |
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes [ ] No
Indicate by check mark whether the registrant has submitted electronically on its corporate Web site, if any, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter)
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during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Applicable Only to Issuers Involved in Bankruptcy Proceedings During the Preceding Five Years:
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.
Not applicable.
Applicable Only to Corporate Issuers:
Class Outstanding as of November 14, 2024
Indicate the number of shares outstanding of each of the issuer’s classes of common equity, as of November 14, 2024.
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TABLE OF CONTENTS
PART I | FINANCIAL INFORMATION | 2 |
ITEM 1 | FINANCIAL STATEMENTS | 3 |
ITEM 2 | MANAGEMENT’S DISCUSSION AND ANAYLSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 12 |
ITEM 3 | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 17 |
ITEM 4 | CONTROLS AND PROCEDURES | 17 |
PART II | OTHER INFORMATION | 17 |
ITEM 1 | LEGAL PROCEEDINGS | 17 |
ITEM 1A | RISK FACTORS | 17 |
ITEM 2 | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS | 17 |
ITEM 3 | DEFAULTS UPON SENIOR SECURITIES | 18 |
ITEM 4 | MINE SAFETY DISCLOSURE | 18 |
ITEM 5 | OTHER INFORMATION | 18 |
ITEM 6 | EXHIBITS | 18 |
SIGNATURES | 19 |
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Part I - FINANCIAL INFORMATION
Item 1. Financial Statements
NU-MED PLUS, INC.
FINANCIAL STATEMENTS
(UNAUDITED)
September 30, 2024
The financial statements included herein have been prepared by the Company, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted. However, 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. These financial statements should be read in conjunction with the Form 10-K for the period ended December 31, 2023, accompanying notes, and with the historical financial information of the Company. The results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024.
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Nu-Med Plus, Inc.
Financial Statements
(Unaudited)
Table of Contents
Page No. | ||
Condensed Balance Sheets at September 30, 2024 (unaudited) and December 31, 2023 | 4 | |
Condensed Statements of Operations for the three and nine months ended September 30, 2024 and 2023 (unaudited) |
5 | |
Condensed Statements of Stockholders’ Deficit for the three and nine months ended September 30, 2024 and 2023 (unaudited) |
6 | |
Condensed Statements of Cash Flows for the nine months ended September 30, 2024 and 2023 (unaudited) |
7 | |
Notes to the Condensed Financial Statements (unaudited) | 8 | |
5
NU-MED PLUS, INC.
Condensed Balance Sheets
September 30, | December 31, | ||||
2024 (unaudited) |
2023
| ||||
ASSETS | |||||
Current assets | |||||
Cash | $ |
$ | |||
Prepaid expenses | |||||
Total current assets | |||||
Long-term assets | |||||
Property and equipment, net | |||||
Total assets | $ |
$ | |||
LIABILITIES AND STOCKHOLDERS' DEFICIT | |||||
Current liabilities | |||||
Accounts payable | $ |
$ | |||
Accounts payable – related party | |||||
Note payable | |||||
Accrued expenses | |||||
Total current liabilities | |||||
Long-term liabilities | - | - | |||
Total liabilities | |||||
Commitments and contingencies | |||||
Stockholders' deficit | |||||
Preferred stock; $ |
|||||
Common stock; $ |
|
| |||
Additional paid-in capital | |||||
Accumulated deficit | ( |
( | |||
Total stockholders' deficit | ( |
( | |||
Total liabilities and stockholders' deficit | $ |
$ |
The accompanying notes are an integral part of these condensed financial statements.
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NU-MED PLUS, INC.
Condensed Statements of Operations
For the Three and Nine Months Ended September 30, 2024 and 2023
(Unaudited)
Three months ended September 30, 2024 |
Three months ended September 30, 2023 |
Nine months ended September 30, 2024 |
Nine months ended September 30, 2023 | |||||||||
Revenue | $ | $ | $ | $ | ||||||||
Operating expenses | ||||||||||||
General and administrative expense |
||||||||||||
Rent expense | ||||||||||||
Professional and consulting fees |
||||||||||||
Total operating expenses | ||||||||||||
Operating Loss | ( |
( |
( |
( | ||||||||
Other income (expense) | ||||||||||||
Interest expense | ( |
( |
( |
( | ||||||||
Total other income (expense) | ( |
( |
( |
( | ||||||||
Net loss before income tax | ( |
( |
( |
( | ||||||||
Income tax expense | ||||||||||||
Net loss | $ | ( |
$ | ( |
$ | ( |
$ | ( | ||||
Basic and diluted loss per share | $ | ( |
$ | ( |
$ | ( |
$ | ( | ||||
Weighted average common shares outstanding - basic and diluted |
The accompanying notes are an integral part of these condensed financial statements.
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NU-MED PLUS, INC.
Condensed Statements of Stockholders’ Deficit
For the Three and Nine Months Ended September 30, 2024 and 2023
(Unaudited)
Preferred Stock | Common Stock | Additional Paid-In | Accumulated | ||||
Shares | Amount | Shares | Amount | Capital | deficit | Total | |
Balance, January 1, 2024 | $ |
$ |
$ ( |
$ ( | |||
Net loss for the three months ended March 31, 2024 | - | - | ( |
( | |||
Balance, March 31, 2024 | $ |
$ |
$ ( |
$ ( | |||
Net loss for the three months ended June 30, 2024 | - | - | ( |
( | |||
Balance, June 30, 2024 | $ |
$ |
$ ( |
$ ( | |||
Net loss for the three months ended September 30, 2024 | - | - | ( |
( | |||
Balance, September 30, 2024 | $ |
$ |
$( |
$ ( |
Preferred Stock | Common Stock | Additional Paid-In | Accumulated | |||||
Shares | Amount | Shares | Amount | Capital | deficit | Total | ||
Balance, January 1, 2023 | $ |
$ |
$ ( |
$ ( | ||||
Net loss for the three months ended March 31, 2023 | - | - | ( |
( | ||||
Balance, March 31, 2023 | $ |
$ |
$ ( |
$ ( | ||||
Net loss for the three months ended June 30, 2023 | - | - | ( |
( | ||||
Balance, June 30, 2023 | $ |
$ |
$ ( |
$ ( | ||||
Net loss for the three months ended September 30, 2023 | - | - | ( |
( | ||||
Balance, September 30, 2023 | $ |
$ |
$( |
$ ( | ||||
The accompanying notes are an integral part of these condensed financial statements.
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Nu-Med Plus, Inc.
Condensed Statements of Cash Flows
(Unaudited)
Nine months ended September 30, 2024 |
Nine months ended September 30, 2023 | |||
Cash flows from operating activities: | ||||
Net loss | $( |
$ ( | ||
Adjustment to reconcile net income (loss) to net cash used in operating activities: |
||||
Changes in operating assets and liabilities: | ||||
Prepaid expenses | ||||
Accounts payable | ( | |||
Accounts payable-related party | ||||
Accrued expense | ||||
Net cash used in operating activities | ( |
( | ||
Cash flows from investing activities: | ||||
Net cash provided by investing activities | ||||
Cash flows from financing activities | ||||
Net cash provided by financing activities | ||||
Net change in cash | ( |
( | ||
Cash at beginning of period | ||||
Cash at end of period | $ |
$ | ||
Supplemental schedule of cash flow information | ||||
Cash paid for interest | ||||
Cash paid for income tax |
The accompanying notes are an integral part of these condensed financial statements.
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Nu-Med Plus, Inc.
Notes to the Condensed Financial Statements
September 30, 2024
Unaudited
NOTE 1 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
a. Basis of Presentation
The accompanying unaudited condensed financial statements include the accounts of Nu-Med Plus, Inc. (the “Company”). These financial statements are condensed and, therefore, do not include all disclosures normally required by accounting principles generally accepted in the United States of America. Therefore, these statements should be read in conjunction with the most recent annual financial statements of Nu-Med Plus, Inc. for the year ended December 31, 2023 included in the Company’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2024. In particular, the Company’s significant accounting principles were presented as Note 1 to the Financial Statements in that report. In the opinion of management, all adjustments necessary for a fair presentation have been included in the accompanying condensed financial statements and consist of only normal recurring adjustments. The results of operations presented in the accompanying condensed financial statements are not necessarily indicative of the results that may be expected for the full year ending December 31, 2024.
On April 25, 2024, Nu-Med Plus, Inc. (the “Company”) entered into a Share Exchange Agreement (the “Share Exchange Agreement”) for the merger of YourSpace America, Inc. (“YSA”) into the Company (the “Transaction”). The Company and YSA may be referred to herein each as a “Party” and, collectively, as the “Parties.” On August 12, 2024, the Share Exchange Agreement was amended to provide that the closing would take place upon the completion of the audit of the YSA financial statements for the year ended December 31, 2023.
Additionally, the Board of Directors of the Company appointed Mr. Colvin as the Company’s President, Chief Executive Officer, and Director, at which time William Hayde was appointed Executive Chairman of the Board. Keith Merrell will continue to serve as the Company’s Chief Financial Officer and Director, and Jeffrey Robins will continue to serve as Director.
On October 28, 2024 the Company received notice from YSA that they were terminating the Share Exchange Agreement. Accompanying their notice was a letter of resignation from Mr. Colvin, resigning his position as President, Chief Executive Officer, and Director effective immediately. The Board of Directors of the Company accepted the resignation and appointed Mr. Hayde to the office of President and Chief Executive Officer. The Company filed a Form 8-K disclosing the termination of the Share Exchange Agreement and the change in executive officers on October 30, 2024.
b. Revenue Recognition
The Financial Accounting Standards Board (“FASB”) issued new guidance for the recognizing and reporting of revenue in contracts with customers. The effective date for implementation for public companies was January 1, 2018.
The new guidance established a five-step analysis to be followed when determining the recognition of revenue.
1. | Identify the contract with a customer. |
2. | Identify the performance obligations in the contract. |
3. | Determine the transaction price. |
4. | Allocate the transaction price to the performance obligations in the contract. |
5. | Recognize revenue when, or as, the reporting organization satisfied a performance obligation. |
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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.
c. Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
d. Cash and Cash Equivalents
The Company considers all deposit accounts and investment accounts with an original maturity of 90 days or less to be cash equivalents. The cash balance we currently have on deposit is within the limits for which the FDIC insures.
e. Property and Equipment
Property and equipment is stated at cost. Expenditure
for minor repairs, maintenance, and replacement parts which do not increase the useful lives of the assets are charged to expense as incurred.
Expenditures, exceeding $
f. Fair Value Measurements
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB Accounting Standards Codification (“ASC”) Topic 820 establishes a three-tier fair value hierarchy that prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs (level 3 measurements), as follows:
Level 1 - Quoted market prices in active markets for identical assets or liabilities;
Level 2 - Inputs other than level one inputs that are either directly or indirectly observable; and
Level 3 - Unobservable inputs developed using estimates and assumptions, which are developed by the reporting entity and reflect those assumptions that a market participant would use.
All cash, accounts payable and accrued liabilities are carried at cost, which approximates fair value due to the short-term nature of these financial instruments. Additionally, we measure certain financial instruments at fair value on a recurring basis.
g. Earnings per Share
The computation of earnings per share of common stock is based on the weighted average number of shares outstanding during the period of the financial statement. The company included -0- and -0- shares subscribed but unissued in its calculation of basic and diluted earnings per share for the nine months ended September 30, 2024 and 2023, respectively.
Diluted earnings per share is computed using the weighted average number of common shares plus dilutive common
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share equivalents outstanding during the period. As
of September 30, 2024 and 2023 there were -
h. Concentrations and Credit Risk - The Company has relied on a small group of investors to fund its operations. If this group becomes unable or unwilling to provide additional funding, the Company may be unable to remain in business or to execute on its business plan.
i. Income Taxes
Deferred taxes are provided on an asset and liability approach whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carryforwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax basis. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.
j. Stock-based Compensation
The Company, in accordance with ASC 718, Compensation – Stock Compensation, records all share-based payments to employees at the grant-date fair value of the equity instruments issued. In accordance with ASC 718-10-30-9, Measurement Objective – Fair Value at Grant Date, the Company uses the closing price of the stock, as quoted by NASDAQ, on the date of the grant. The Company believes this pricing method provides the best estimate of fair the fair value of the consideration given. Compensation cost is recognized over the requisite service period.
k. Recent Accounting Pronouncements
The Company has reviewed all recently issued, but not yet adopted, accounting standards in order to determine their effects, if any, on its results of operation, financial position and cash flows. Based on that review, the Company believes that none of these pronouncements will have a significant effect on its current or future earnings or operations.
NOTE 2 - GOING CONCERN
The Company acknowledges that the funds on hand as
of September 30, 2024, 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. Planned expenditures are approximately $
NOTE 3 – PROPERTY AND EQUIPMENT
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September 30, 2024 | December 31, 2023 | |||
Computer and office equipment | $ |
$ |
||
Accumulated depreciation | ( |
( |
||
Total Property and Equipment |
|
|
Depreciation expense for the nine months ended September 30, 2024 and 2023 was
and $-0-, respectively.
NOTE 4 - PREFERRED STOCK
On October 19, 2011, the Company filed Articles of
Incorporation with the State of Utah so as to authorize
NOTE 5 - COMMON STOCK
There are
NOTE 6 - COMMITMENTS AND CONTINGENCIES
Lease Obligations
The Company is currently utilizing office space provided
by its officers, for which no charge is being made. The Company rents space for its laboratory on a month-to-month basis at $
NOTE 7 – EMPLOYMENT AGREEMENTS
Mr. Hayde and Mr. Merrell have received employment
agreements. The agreements provide for no compensation until such time as a major funding event has been finalized, at which time the
rate of compensation will be established by the Board of Directors. Mr. Hayde and Mr. Merrell were being provided $
NOTE 8 - SUBSEQUENT EVENTS
YourSpace America notified the Company on October 28, 2024 that they were terminating the Share Exchange Agreement. The Company accordingly filed a Form 8-K on October 30, 2024 disclosing the termination of that agreement and the change in executive officers resulting from that termination. (See Note 1 )
The Company has evaluated all other subsequent events pursuant to ASC Topic 855 and has determined that there are no events that require disclosure as of the date of issuance.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Special Note Regarding Forward-Looking Statements
Certain statements in this Report constitute “forward-looking statements.” Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that might cause such a difference include, among others, uncertainties relating to general economic and business conditions; industry trends; changes in demand for our products and services; uncertainties relating to customer plans and commitments and the timing of orders received from customers; announcements or changes in our pricing policies or that of our competitors; unanticipated delays in the development, market acceptance or installation of our products and services; changes in government regulations; availability of management and other key personnel; availability, terms and deployment of capital; relationships with third-party equipment suppliers; and worldwide political stability and economic growth. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date the statement was made.
Critical Accounting Policies and Estimates
The preparation of financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the Financial Statements and accompanying notes. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. Actual results could differ from these estimates under different assumptions or conditions.
The Company’s accounting policies are more fully described in Note 2 of the audited financial statements in our recently filed Form 10-K. As discussed in Note 2, the preparation of financial statements and related disclosures in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions about the future events that affect the amounts reported in the financial statements and the accompanying notes. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. Actual differences could differ from these estimates under different assumptions or conditions. The Company believes that the following addresses the Company’s most critical accounting policies.
We recognize revenue in accordance with ASC 606, which establishes a five-step analysis to be followed when determining the recognition of revenue. 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.
Our policy for our allowance for doubtful accounts will be maintained to provide for losses arising from customers’ inability to make required payments. If there is deterioration of our customers’ credit worthiness and/or there is an increase in the length of time that the receivables are past due greater than the historical assumptions used, additional allowances may be required.
We account for income taxes in accordance with the Tax Cuts and Jobs Act and SAB 118.
BUSINESS OVERVIEW
NU-MED PLUS, INC., a Utah corporation (“NU-MED” or the “Company”) was incorporated in October 2011 in the state of Utah to develop, manufacture and market new technologies utilizing nitric oxide in the medical device
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field, primarily through the creation of a nitric oxide generating compound formulation and delivery systems. To date we have developed a hospital nitric oxide delivery system, a clinical nitric oxide delivery system, a mobile rechargeable device to deliver nitric oxide gas, and a nitric oxide system that can be used for research applications. NU-MED is headquartered in Salt Lake City, Utah.
On May 15, 2023, Nu-Med Plus, Inc. entered into a non-binding letter of intent with YourSpace America, Inc. (“YSA”), a Delaware corporation, for the merger of YSA into Nu-Med, subject to due diligence. Pursuant to the LOI, the Parties will enter into an agreement and plan of merger which will be mutually negotiated and drafted by the Parties. The Company (as the surviving entity) will assume all liabilities of YSA (as the merging entity) including any liabilities arising from, or in connection with, any contracts assigned by YSA to the Company as part of the Transaction.
On April 25, 2024, Nu-Med Plus, Inc. (the “Company”) entered into a Share Exchange Agreement (the “Share Exchange Agreement”) for the merger of YourSpace America, Inc. (“YSA”) into the Company (the “Transaction”). The Company and YSA may be referred to herein each as a “Party” and, collectively, as the “Parties.” While the terms have been set, the agreed-upon transaction will not be closed until the completion of the YSA audit for the year ended December 31, 2023. On August 12, 2024, the Shae Exchange Agreement was amended to provide that the closing would take place upon the completion of the audit of the YSA financial statements for the year ended December 31, 2023.
On October 28, 2024 the Company received notice from YSA that they were terminating the Share Exchange Agreement. Accompanying their notice was a letter of resignation from Mr. Colvin, resigning his position as President, Chief Executive Officer, and Director effective immediately. The Board of Directors of the Company accepted the resignation and appointed Mr. Hayde to the office of President and Chief Executive Officer. The Company filed a Form 8-K disclosing the termination of the Share Exchange Agreement and the change in executive officers on October 30, 2024.
Business
The mission of NU-MED is to design, develop, and market technologies in the medical device field. Our technologies will focus on market niches in high growth trend areas. We hope each developed technology will fill a current need in medical procedures by improving upon an existing technology or device, or by designing a device to serve a need that is clearly defined and acknowledged by medical professionals.
NU-MED is a medical device company principally engaged in the design, innovation, development, enhancement and commercialization of beginning, early, and selective later-stage quality medical devices. The mission of NU-MED is to design, develop, and market technologies utilizing nitric oxide in the medical device field. Our technologies focus on market niches in high growth trend areas. Our products are developed to target a current need in medical procedures by improving upon an existing technology or device or by designing a device to serve a currently unfilled need that is clearly defined and acknowledged by medical professionals. Our focus has been on the creation of a nitric oxide generating formulation, a hospital bedside nitric oxide delivery system, a clinical unit for use in medical clinics and rehabilitation centers and a mobile device to deliver nitric oxide gas to offer new and innovative solutions to hospitals, health systems and the medical community throughout the world.
Development of our products has been suspended until such time as a capital infusion is received which will enable the funding of further development. The following is a description of the medical application for the products that have been under development and the status of each of those products:
Nitric oxide is an extremely important bio-mediator in the human body that is produced from the amino acid l-arginine. Nitric oxide has anti-inflammatory properties, antibacterial, antiviral and antifungal properties which make it useful in certain medical treatments. At the present time inhaled nitric oxide (INO) is used as a selective
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vasodilator in infants. The only FDA approved use of nitric oxide at this time is for the treatment of Hypoxia in premature infants and newborn babies. Management is not aware of any other potential uses of nitric oxide that have been cleared by the FDA, but this may change as new submittals are made. The heavy cost of delivering nitric oxide to patients has created limitations in its use. Discoveries that have been made since the first FDA approved use of nitric 0oxide in 1999 have led to a number of new potential uses, which still need FDA approval, in a wide variety of diseases and health complications, including COPD, flu viruses, bacterial infections, tuberculosis, non-healing wounds, head injuries and much more. NU-MED hopes to take advantage of the expanding medical uses of nitric oxide by developing a new method to generate nitric oxide that reduces the delivery costs and can be used in a variety of medical and research settings. Given NU-MED’s size, we do not anticipate being involved in any clinical studies on new uses of nitric oxide and will rely on other parties to continue to advance the uses of nitric oxide.
NU-MED PLUS has focused on the development of five distinct products for the delivery of nitric oxide. NU-MED products have not been fully developed; therefore we have not made any submission for FDA approval under any medical use.
1. | Nitric oxide proprietary formulation. Generates nitric oxide gas on demand, eliminating the need for |
Com0pressed gas cylinders.
2. A hospital delivery device with controls and safety monitors built in that delivers inhaled nitric oxide to a patient at therapeutic levels. This delivery system is intended for hospitals specifically intensive care units. The goal is to have a system that delivers a metered therapeutic dose (up to 40 ppm) of nitric oxide via a ventilator. The core technology allows dilution of nitric oxide to therapeutic levels to be accomplished without the use of injectors or valves. Safeguards such as concentration monitoring, flow and gas purity would be standard.
3. A clinical delivery unit that is designed for treatment in an office or physician’s clinic. A unit powered by a wall outlet, administration of the nitric oxide would be via cannula or non-rebreather face mask
4. A compact, mobile/portable rechargeable device to deliver inhaled nitric oxide gas. The portable system necessitates a design which can be deployed where a reliable source of power is not available or is difficult to access. The key feature is a rechargeable battery pack that powers the unit for the full duration of a therapeutic session. It can be recharged using existing electrical sources, a solar array or other alternative energy source. The unit is designed as a low power but fully functional nitric oxide delivery system for inhalation therapy, that can be used as a transport device during the movement of a patient or as a delivery device in those remote areas of the world that do not currently have electrical power readily available.
5. A disposable unit that will deliver a therapeutic dose of nitric oxide to a patient and will then be placed into a container to be incinerated. This unit would be used for the treatment of patients in a pandemic, where a large number of patients must be treated and there is insufficient capacity to sterilize the unit after use by each patient. The dispensing devices would be isolated and destroyed after use to ensure that another patient is not exposed to the bacteria or virus carried by the patient originally treated.
6. A unit that is one of the world’s first nitric oxide dilution systems designed for research. A patent pending technology utilizes pure 100% nitric oxide from a pressurized tank source and dilutes it with air or other non-reactive diluent gas to provide a 1 to 500 ppm source of high purity nitric oxide for investigational applications.
The principal gas we aim to generate through each of our systems described above is medical grade nitric oxide, along with other various combinations of beneficial medical gases. Non-medical grade nitric oxide gas is produced and sold commercially by major gas companies as a specialty gas mixture and calibration gas. Nitrogen dioxide is present in all nitric oxide gas currently produced. Its presence limits the size of the dose of nitric oxide gas that can be administered for prospective uses in both humans and animals.
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A longer-term goal is to further develop our proprietary compound formulation option that will be utilized to produce medical grade nitric oxide for use in all delivery units. 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. For a number of years the only approved and available medical grade nitric oxide delivery device was a product named Inomax. Since this is a single source market there is no price competition and price is set at a "market can bear" level. 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. The cost of materials and labor for the NU-MED product is anticipated to be low, while still providing attractive margins. Our product must have a known shelf life and be available in various configurations to yield known concentrations and volumes of gas. Packaging is a critical developmental process that we will address after completion of our formulation.
We approximate that the sale of our research unit for non-clinical laboratory work could take place earlier than FDA approval. 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. Even with sales to laboratories or other uses, we will require additional funding, which we currently do not have in place and have no assurance that we will be able to obtain, or to obtain at acceptable rates.
All human medical uses of nitric oxide gas require FDA approval prior to initiating sales in the United States and the approval of similar international agencies in their respective countries. Approval can be a long and expensive process, with no assurance that any such approval can or will be obtained. Our products from the compound formulation for nitric oxide to our delivery machines will have to be approved by the FDA prior to any sales for human use. Although the FDA can approve “uses” for nitric oxide and such uses can be expanded, our products, both the formulations and equipment, would also have to be approved to be used in association with the treatment using nitric oxide. Accordingly, although the use of nitric oxide for the treatment of hypoxia in newborns is approved by the FDA, we still would need to have our dispensing unit and compound approved by the FDA for such treatment. In order for our dispensing unit to be used we would not have to prove the efficacy of the treatment but only that our product and compounds are “substantially equivalent” to those already approved by the FDA. Even this level of approval requires time, carries substantial costs, and creates additional uncertainty as to our ability to bring a product to the marketplace. We currently do not have the funds to seek such an approval. We are currently wor0king to secure funding that will enable us to submit the hospital unit for FDA approval.
LIQUIDITY AND CAPITAL RESOURCES
At September 30, 2024, we had assets of $6,841 with current assets of $6,841 and liabilities of $211,382. Our current assets consisted primarily of $4,041 in cash and prepaid expenses in the amount of $2,800. Our working capital deficiency at September 30, 2024 was $204,541. We currently have no revenue and have had to rely on loans from shareholders or sale of our stock to cover expenses. Without additional capital, we will not be able to stay in business and move our business plan forward. We anticipate, based on our preliminary budgets, that we will need $300,000 in additional financing for the next twelve months to cover our corporate overhead and need an additional $900,000 to cover ongoing product development. Since we will not have a commercial product in the next twelve months, we will have to continue to rely on outside funding to support our operations and product development and testing efforts. Given the financial state of NU-MED, we will not be able to seek traditional bank financing and have to rely on private stock sales as well as potential loans from investors and shareholders. We cannot estimate the full costs to bring our proposed product to market or the timing of such commercialization. Given the nature of our product being in the medical field, testing is very expensive and we would need more capital prior to the completion of the testing phase. Any refinement or modification of the product after the prototype is
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developed would also require additional capital. At this time, we will have to continue to rely on outside capital and a budget that may require adjustment as we move further in the product development phase.
RESULTS OF OPERATIONS
Three Month Periods Ended September 30, 2024 and 2023
For the three months ended September 30, 2024 and 2023, we had no revenues and operating expenses of $17,417 and $15,146, respectively. The increase in operating expenses results primarily from increases in professional fees of $4,950 and filing fees of $2,188, offset by a decrease in investor relations fees of $3,298 and rent expense of $3,300. For the three-month period ended September 30, 2024 we recognized interest expense of $1,260. We had a net loss of $18,677 in 2024, compared to a net loss of $16,406 in 2023. We do not anticipate any revenue for the foreseeable future as our products are still in the development stage.
Nine Month Periods Ended September 30, 2024 and 2023
For the nine months ended September 30, 2024 and 2023, we had no revenues and operating expenses of $54,037 and $65,190, respectively. The decrease in operating expenses results primarily from a decrease in legal fees of $4,200 and rent expense of $9,600. For the nine-month period ended September 30, 2024 we recognized interest expense of $3,753. We had a net loss of $57,790 in 2024, compared to a net loss of $68,930 in 2023. We do not anticipate any revenue for the foreseeable future as our products are still in the development stage
Off-Balance Sheet Arrangements.
The Company does not have any off-balance sheet arrangements and it is not anticipated that the Company will enter into any off-balance sheet arrangements.
Forward-looking Statements
Our Company and our representatives may from time to time make written or oral statements that are “forward-looking,” including statements contained in this Quarterly Report and other filings with the Securities and Exchange Commission and in reports to our Company’s stockholders. Management believes that all statements that express expectations and projections with respect to future matters, as well as from developments beyond our Company’s control including changes in global economic conditions are forward-looking statements within the meaning of the Act. These statements are made on the basis of management’s views and assumptions, as of the time the statements are made, regarding future events and business performance. There can be no assurance, however, that management’s expectations will necessarily come to pass. Factors that may affect forward-looking statements include a wide range of factors that could materially affect future developments and performance, including the following:
Changes in Company-wide strategies, which may result in changes in the types or mix of businesses in which our Company is involved or chooses to invest; changes in U.S., global or regional economic conditions, changes in U.S. and global financial and equity markets, including significant interest rate fluctuations, which may impede our Company’s access to, or increase the cost of, external financing for our operations and investments; increased competitive pressures, both domestically and internationally, legal and regulatory developments, such as regulatory actions affecting environmental activities, the imposition by foreign countries of trade restrictions and changes in international tax laws or currency controls; adverse weather conditions or natural disasters, such as hurricanes and earthquakes, labor disputes, which may lead to increased costs or disruption of operations.
This list of factors that may affect future performance and the accuracy of forward-looking statements is illustrative, but by no means exhaustive. Accordingly, all forward-looking statements should be evaluated with the understanding of their inherent uncertainty.
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Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not applicable.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
Our management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15c or 15d-15e) under the Exchange Act as of the end of the period covered by this report. Our management does not expect that our disclosure controls and procedures will prevent all error and all fraud. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives.
Based on that evaluation, as of September 30, 2024, 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 SEC’s 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.
Changes in internal control over financial reporting
There have been no changes in internal control over financial reporting that occurred during the last fiscal quarter that has materially affected, or is reasonably likely to materially affect, the internal control over financial reporting.
PART II - OTHER INFORMATION
ITEM 1. Legal Proceedings
None.
ITEM 1A. Risk Factors
Not applicable
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds
Recent Sales of Unregistered Securities
None.
Other Securities Transactions
None.
Use of Proceeds of Registered Securities
None.
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Purchases of Equity Securities by Us and Affiliated Purchasers
During the nine months ended September 30, 2024, we have not purchased any equity securities nor have any officers or directors of the Company.
ITEM 3. Defaults Upon Senior Securities.
Not applicable.
ITEM 4. Mine Safety Disclosure
Not applicable.
ITEM 5. Other Information.
ITEM 6. Exhibits
a) Index of Exhibits:
Exhibit Table # Title of Document Location
31.1 Rule 13a-14(a)/15d-14a(a) Certification – CEO This filing
31.2 Rule 13a-14(a)/15d-14a(a) Certification – CFO This filing
32 Section 1350 Certification – CEO & CFO This filing
101.INS XBRL Instance**
101.XSD XBRL Schema**
101.CAL XBRL Calculation**
101.DEF XBRL Definition**
101.LAB XBRL Label**
101.PRE XBRL Presentation**
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
NU-MED PLUS, INC.,
(Registrant)
November 14, 2024 By: /s/ William Hayde
William Hayde, CEO/Principal Executive Officer
November 14, 2024 By: /s/Keith L. Merrell
Keith L. Merrell, CFO/Principal Accounting Officer
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