Filed 2025-03-31 · Period ending 2024-12-31 · 20,787 words · SEC EDGAR
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# Nu-Med Plus, Inc. (NUMD) — 10-K
**Filed:** 2025-03-31
**Period ending:** 2024-12-31
**Accession:** 0001548123-25-000021
**Source:** [SEC EDGAR](https://www.sec.gov/Archives/edgar/data/1543637/000154812325000021/)
**Origin leaf:** c561009153838d81d77d9e80f93be258b9082650640fa27bed085844258d6b02
**Words:** 20,787
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**UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K**
(Mark One)
[x] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2024
[ ]TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________ to __________
Commission File Number: 000-54808
**NU-MED PLUS, INC.**
(Exact name of registrant as specified in charter)
| Utah | 45-3672530 | |
| (State or other jurisdiction of Incorporation or organization) | (I.R.S. Employer I.D. No.) | |
| 640 Belle Terre Rd Building 2 E Port Jefferson NY | 11777 | |
| (Address of principal executive offices | (Zip Code) | |
****
Issuer's telephone number, including area code: (631) 403-4337
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | |
| None | | | |
Securities registered under Section 12(g) of the Act: Common Stock
Indicate by check mark if the registrant is a well-known seasoned issuer,
as defined in Rule 405 of the Securities Act.
Yes [ ] No [X]
Indicate by check mark if the registrant is not required to file reports
pursuant to Section 13 or 15(d) of the Exchange Act.
Yes [ ] No [X]
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.
Yes [X] No [ ]
Indicate by check mark whether the Registrant has submitted electronically
and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of
Regulation S-T (232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was
1
required to submit and post such files).
Yes [X] No [ ]
Indicate by check mark if disclosure of delinquent
filers in response to Item 405 of Regulation S-K is not contained herein, and not be contained, to the best of registrant's knowledge,
in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.
[ ]
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
definition 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 [] | |
| Non-accelerated filer [X] | Smaller reporting company [X] | |
| | Emerging Growth company [X] | |
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 checkmark whether the registrant has filed a report on and
attestation to its managements assessment of the effectiveness of its internal control over financial reporting under Section 404(b)
of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. [ ]
If securities are registered pursuant to Section 12(b) of the Act, indicate
by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously
issued financial statements. [ ]
Indicate by check mark whether any of those error corrections are restatements
that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant
recovery period pursuant to 240.10D-1(b). [ ]
Indicate by check mark whether the Registrant is a shell company (as defined
in Rule 12b-2 of the Exchange Act).
Yes [ ] No [X]
State the aggregate market value of the voting and
non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average
bid and asked prices of such common equity, as of the last business day of the registrants most recently completed second fiscal
quarter: At June 30, 2024, the Companys last sale price of its stock was $0.0740 resulting in an aggregate market value of our
common stock held by non-affiliates of $3,235,074.
**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:**
Indicate the number of shares outstanding of each of the Registrants
classes of common equity, as of the latest practicable date.
2
| Class | Outstanding as of March 31, 2025 | |
| | | |
| Common Stock | 83,548,469 | |
Documents incorporated by reference: None
3
**TABLE OF CONTENTS**
PART I
|
Item 1. |
Business |
5 | |
|
Item 1A. |
Risk Factors |
14 | |
|
Item 1C. |
Cybersecurity |
18 | |
|
Item 2. |
Properties |
18 | |
|
Item 3. |
Legal Proceedings |
18 | |
|
Item 4. |
Mine Safety Disclosure |
18 | |
PART II
|
Item 5. |
Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities |
18 | |
|
Item 6. |
[Reserved] |
19 | |
|
Item 7. |
Management's Discussion and Analysis of Financial Condition and Results of Operations |
19 | |
|
Item 8. |
Financial Statements and Supplementary Data |
21 | |
|
Item 9. |
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure |
21 | |
|
Item 9A. |
Controls and Procedures |
21 | |
|
Item 9B. |
Other Information |
22 | |
|
Item 9C. |
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections |
22 | |
PART III
|
Item 10. |
Directors, Executive Officers and Corporate Governance |
22 | |
|
Item 11. |
Executive Compensation |
23 | |
|
Item 12. |
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters |
25 | |
|
Item 13. |
Certain Relationships and Related Transactions, and Director Independence |
27 | |
|
Item 14. |
Principal Accounting Fees and Services |
27 | |
PART IV
|
Item 15. |
Exhibits, Financial Statement Schedules |
28 | |
|
Signatures |
30 | |
****
****
4
**PART I**
****
**ITEM 1. BUSINESS**
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.
**Corporate History**
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 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.
EMERGING GROWTH COMPANY STATUS
As part of the Jumpstart Startups Act of 2012 (JOBS
ACT), companies with less than $1.0 billion in gross revenue can qualify as an emerging growth company. We will qualify
as an emerging growth company as defined in the JOBS Act, and, as such, we are eligible to take advantage of certain exemptions from various
reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited
to, (i) not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, (ii)
reduced disclosure obligations regarding executive compensation in our periodic and annual reports, (iii) not being required to comply
with certain new requirements adopted by the Public Company Accounting Oversight Board, or the PCAOB, and (iv) not being required to obtain
stockholder approval of any golden parachute payments not previously approved. We intend to take advantage of the reduced disclosure obligations.
Additionally, we qualify as a Smaller Reporting Company and also have the advantage of not being required to provide the
same level of disclosure as larger companies. Section 107 of the JOBS Act also provides that an emerging growth company can take advantage
of the extended transition period provided in the Securities Act for complying with new or revised accounting standards. In other words,
an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private
companies. We have elected to use the extended transition period for complying with new or revised accounting standards under Section
102(b)(2) of the Jobs Act, that allows us to delay the adoption of new or revised accounting standards that have different effective dates
for public and private companies until those standards apply to private companies. As a result of this election, our financial statements
may not be comparable to companies that comply with effective public company dates.
We could remain an emerging growth company for up
to five years, or until the earliest of (i) the last day of the first fiscal year in which our annual gross revenues exceed one billion
dollars, (ii) the date that we become a large accelerated filer as defined in Rule 12b-2 under the Securities Exchange Act
of 1934, as amended, or the Exchange
5
Act, which would occur if the market value of our
common units that are held by non-affiliates exceeds $700.0 million as of the last business day of our most recently completed second
fiscal quarter, and (iii) the date on which we have issued more than $1.0 billion in non-convertible debt during the preceding three-year
period. At this time, we expect to remain both a Smaller Reporting Company and Emerging Growth Company for
the foreseeable future.
**Business**
NU-MED was organized as 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 are focused 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 to date 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 rechargeable
device to deliver nitric oxide gas to offer solutions to the medical community throughout the world.
**Products**
**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 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 oxide 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-MEDs 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 | |
compressed 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 physicians clinic. A unit powered by a wall outlet, administration of the nitric oxide
would be via cannula or non-rebreather face mask
6
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
sources. 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 worlds 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.
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
7
approved by the FDA, we still will 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 approval. We are currently working to secure
funding that will enable us to submit the hospital unit for FDA approval.
Current Product Development Status
Following is a discussion of the development state
of each of the products. However, no further development work is planned until such time as adequate funding is in place to ensure the
products can be finalized, tested and made ready for submission of approval to the FDA.
****
**Hospital NO Unit**. Our team has created an initial
prototype and is nearing completion of the first production unit for use as a hospital nitric oxide gas delivery system. The device delivers
a continuous intra-breath concentration of therapeutic NO to patients who are on a ventilator in a hospital setting. We are performing
internal testing on the accuracy of the machine and dosage prior to moving forward with any animal or human tests. With any medical product,
it will take a period of refinement and testing before the product is ready for the market.
**Clinical Delivery System.** The clinical system
is a simplified version of the hospital unit. While it can be used in a hospital setting it was designed to be operated and used in a
less medically intensive environment, such as a doctors office or physicians clinic and does not incorporate the alarms
needed in an intensive care setting. It is a smaller and more portable unit, lending itself to clinical use on an as needed basis, rather
than full-time use for which the hospital unit is designed. Administration is via nasal cannula or non-rebreather face mask. Similar to
a dialysis center concept, patients would be treated with nitric oxide in a clinical setting on an as needed basis.
**Portable Delivery System**. Nu-Med has also developed
a prototype lightweight Portable NO Delivery System that can be worn comfortably by patients outside of the hospital setting for underserved
chronic therapies, and for applications within the United States and in developing nations. This product has the capability to deliver
high purity NO to the patient at prescribed intervals for 24 hours per day at controlled doses by means of a nasal cannula or a face mask.
As with our hospital unit, we are in the preliminary testing phase and do not anticipate any commercialization in the near future.
**Reagent Delivery.** During development of the
Nu-Med line of medical nitric oxide delivery systems it was discovered that a system could be built that would provide the research community
with a variable concentration source of nitric oxide for conducting research and experiments. A preliminary system has been built that
can provide a wide range of concentrations and flow rates of NO. This was reduced to practice and a delivery system is now available
for research use.
****
**Future Product Development.** Utilizing our core
technology, our newest product to be investigated is a one-time Single Treatment Disposable unit which will give rapid access to short-term
NO treatment. The entire unit is disposed of after treatment and is unique in the marketplace, with no competitive product available.
We also are investigating a Wound Healing System which may reduce the surgical loss of a partial or full foot for diabetics by healing
diabetic wounds and sores caused by their disease.
****
**Existing Clinical Applications of Inhaled Nitric Oxide and Potential
Markets**
Nitric oxide can be safely inhaled utilizing our delivery
device, through a ventilator, face mask, by nasal cannula, or via an endotracheal tube. An ideal inhaled NO delivery device requires delivery
synchronized with respiration and minimal production of NO2 and should be simple to use with full monitoring capacity (high
and low alarms and precise monitoring of NO, NO2, and O2). Our delivery devices were designed with all of these
requirements in mind. As a result, we believe it will be the best and most efficient delivery system available when it is commercialized.
8
Since the inception of the only FDA approved treatment
of hypoxia in newborns with nitric oxide (INOMAX from Ikaria Holdings) initial research has shown approximately 394,000 patients have
been treated worldwide over a ten-year period. Management believes the cost of a typical nitric oxide delivery system is approximately
$30,000 each. Market expansion in the US will occur based on FDA approval for other medical uses of nitric oxide therapies.
Competition
Large companies with established brand names have
a distinct advantage in the medical device arena. The cost of developing a device, followed by the costs of testing and licensing, favor
larger, well-financed and established companies. It will be difficult for NU-MED to compete in this industry, and we will be required
to focus on the niche products if we hope to be able to compete. The number of companies that have a product or products involving nitric
oxide and free radicals is quite large and difficult to determine precisely as this is not the focus of these companies.
In addition to companies that may be working on similar
solutions in the nitric oxide space but have not been public in any product offerings, NU-MED considers the following companies as direct
competitors in the nitric oxide market space which they anticipate entering. This does not preclude that large pharmaceutical or medical
supply companies will enter the critical care market with substantially similar products or systems.
Mallinckrodt Inc. acquired the company which, at that
time, had the only FDA approved nitric oxide (INOMAX) delivery system for use in medical facilities. The FDA approval is limited to the
treatment of persistent pulmonary hypertension in newborns (PPHN). Mallinckrodt Inc. has submitted several other specific medical uses
of nitric oxide to the FDA for approval. The INOMAX system consists of a pressurized tank source of nitric oxide gas and a delivery and
monitoring system and is intended for non-portable hospital use.
GeNO LLC is a technology company focused on their
GeNOsyl Nitrosyl system of nitric oxide generation and delivery. This is a unique patented system based on the conversion of nitrogen
dioxide/dinitrogen tetroxide to pure nitric oxide. Several delivery platforms have been submitted for FDA approval. The FDA has approved
the GeNOsyl Advanced Delivery System (ADS) for use with neonates.
Beyond Air (formerly AIT Therapeutics) (AITB) is a
company that has acquired technology that produces nitric oxide from air through electrical discharge. They are currently in clinical
trials testing the product for use in the treatment of cystic fibrosis and chronic obstructive pulmonary distress.
Many of our competitors, either alone or with their
strategic partners, may have substantially greater financial, technical and human resources than we do and significantly greater experience
in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of products, and the commercialization
of those products. Accordingly, our competitors may be more successful than we may be in obtaining approval for therapies or delivery
hardware and achieving widespread market acceptance. We anticipate that we will face intense and increasing competition as new drugs and
advanced technologies become available.
Employees
The Company currently has two employees and relies
on its officers and consultants for most of its activities.
****
**Regulations**
****
Our proposed products would use nitric oxide gas for
use in medical treatment. Accordingly, our products will require prior FDA Class II approval. We have not submitted our products for approval,
and it is expected to take many years and may not be obtained, even after expending substantial resources in such efforts. Various laws
and regulations govern or influence the research and development, manufacturing, safety, labeling, storage, record keeping and marketing
of our products. The lengthy process of seeking these approvals and the subsequent
9
compliance with applicable laws and regulations require
the expenditure of substantial resources. Any failure by us to obtain or maintain, or any delay in obtaining or maintaining, regulatory
approvals could materially adversely affect our business. Our policy will be to conduct our research and development activities in compliance
with current FDA guidelines and with comparable guidelines in other countries where we may be conducting clinical trials or other developmental
activities.
The following is a brief summary of applicable governmental
regulations to which we may be subject in our planned business operations related to the use of our products in the medical field. It
should be noted that the application for FDA regulatory approval of our devices is a long and costly pathway. As we do not currently have
the capital to engage in any regulatory approval, for the foreseeable future we will be focused on the development of our technology and
additional patent applications.
Clinical testing, manufacturing and marketing of human
pharmaceutical products require prior approval from the FDA and comparable agencies in foreign countries. The FDA has established mandatory
procedures and safety and efficacy standards that apply to the testing, manufacture and marketing of such products in the United States.
In the United States, these procedures include pre-clinical studies, the filing of an Investigational New Drug Application ("IND")
or equivalent, human clinical trials and approval of a New Drug Application ("NDA"). The results of pre-clinical testing, which
include laboratory evaluation of product chemistry and animal studies to assess the potential safety and efficacy of the product and its
formulations, must be submitted to the FDA as part of an IND that must be reviewed before clinical testing can begin.
The results of the preclinical and clinical testing
are then submitted to the FDA in the form of an NDA for approval to commence commercial sales. The FDA may, in responding to an NDA, grant
marketing approval, request additional information or deny the approval if it determines that the NDA does not provide an adequate basis
for approval. Among the conditions for an NDA approval is the requirement that the prospective manufacturer's quality control and manufacturing
procedures conform on an ongoing basis with current Good Manufacturing Practices ("GMP"). In complying with GMP, we must continue
to expend time, money and effort in the areas of production and quality control to ensure full compliance or engage the services of outside
contractors who are well versed in compliance with these requirements. Following approval of the NDA, we are subject to periodic inspections
by the FDA. Any determination by the FDA of manufacturing deficiencies could materially adversely affect our business.
European countries generally follow the same procedures.
The European Union has established a unified filing system administered by the Committee for Proprietary Medicinal Products ("CPMP")
designed to reduce the administrative burden of processing applications for pharmaceutical products derived from new technologies. Following
CPMP review and approval, marketing applications are submitted to member countries for final approval and pricing approval, as appropriate.
In addition to obtaining regulatory approval of products, it is generally necessary to obtain regulatory approval of the facility in which
the product will be manufactured. The approval process for medical devices in Europe is similar but is administered by private certification
organizations known as Notified Bodies, which are accredited by each member state of the European Union. The receipt of regulatory approvals
often takes several years, involves the expenditure of substantial resources and depends on a number of factors, including the severity
of the disease in question, the availability of alternative treatments and the risks and benefits demonstrated in clinical trials. On
occasion, regulatory authorities may require larger or additional studies, leading to unanticipated delay or expense. There can be no
assurance that any approval will be granted and, even if granted, such approval may be withdrawn if compliance with regulatory standards
is not maintained. In addition, the regulatory approval processes for products in the U.S., European countries and other countries around
the world are undergoing or may undergo changes, and we cannot predict what effect any changes in the regulatory approval process may
have on our business.
Clinical testing of an unapproved significant-risk
medical device requires FDA approval in the form of an Investigational Device Exemption (IDE). The IDE application provides information
to the FDA on device design and qualifications, as well as on the study protocol. The FDA is mandated to respond to the IDE application
within 30 days. An IDE may also be required for studies in which an approved device is used for a purpose distinct from its
10
approved indication. This is typically the case when
a trial is sponsored by a company for the purpose of expanding the indication of a device or making significant changes in the instructions
for use.
Medical devices are regulated in the United States
by the Center for Devices and Radiological Health (CDRH) of the FDA. The FDA/CDRH mandate is to promote and protect public health by making
safe and effective medical devices available in a timely manner. The standard for demonstrating safety and effectiveness is determined
in part by the risk associated with the device in question. Devices are classified according to their perceived risk using a 3-tiered
system (Class I, II, or III).
Class I devices (lowest risk) are subject to general
controls, which are published standards pertaining to labeling, manufacturing, post-market surveillance, and reporting. Devices are placed
into Class I when there is reasonable assurance that general controls alone are adequate to assure safety and effectiveness. The general
controls that typically apply to Class I devices include prohibitions against adulteration and misbranding, requirements for establishing
registration and device listing, adverse event reporting, and good manufacturing practices. Furthermore, remedies including seizure, injunction,
criminal prosecution, civil penalties, and recall authority are provided to the FDA. Formal FDA review is not required for most Class
I devices before their market introduction.
Class II devices are those higher-risk devices for
which general controls alone have been found to be insufficient to provide reasonable assurance of safety and effectiveness, but for which
there is adequate information available to establish special controls. Special controls may include performance standards, design controls,
and post-market surveillance programs. In addition, most Class II devices require FDA clearance of a premarket notification application
(PMA or 510(k)) before the device may be marketed. In the 510(k) applications, the medical device manufacturer must provide data to demonstrate
that the new device is substantially equivalent to a legally marketed device. Although substantial equivalence can usually
be demonstrated on the basis of bench and animal testing alone, approximately 10% of 510(k) applications include clinical data.
Class III devices, such as heart valves, pacemakers/implantable
cardioverter-defibrillators, and coronary stents, are judged to pose the highest potential risk. These devices are either life-sustaining/supporting,
of substantial importance in preventing impairment of human health, or present a high risk of illness or injury. Consequently, general
and special controls alone are inadequate to provide reasonable assurance of safety and effectiveness. Most Class III devices require
FDA approval of a PMA before they can be legally marketed. Approval of the PMA generally requires clinical data demonstrating reasonable
assurance that the device is safe and effective in the target population.
The Human Device Exemption (HDE) is a new pathway
to allow for commercialization of Class III devices designed to address small markets, i.e., diseases or conditions that affect fewer
than 4,000 patients in the United States each year. Approval of an HDE requires demonstration that the device is safe and the probable
benefits outweigh the probable risks. Although the process may require smaller clinical trials, an HDE device must continue to operate
under local IRB approval at each participating institution and must continue to collect case report forms akin to an ongoing clinical
trial. The PMA process typically involves a series of studies starting with first clinical use and culminating in a multicenter, prospective
randomized control trial (pivotal trial). The complexity and extent of the clinical testing program is dictated by the nature of the device
and its proposed use. The clinical study program is developed by the company in conjunction with clinician investigators, all in close
collaboration with the FDA/CDRH.
The first and arguably most important step in this
process is the pre-IDE meeting, in which the company, often accompanied by the lead clinical investigator(s), meets with the FDA/CDRH
to present data about the device, its clinical development program, and its intended use after approval. The FDA/CDRH staff reviews existing
bench and animal data (as well as any outside-the-United States clinical data) and makes informal, non-binding suggestions regarding the
need (if any) for additional pre-clinical data (bench and animal), as well as the study design. The sponsor then submits an IDE application
to the FDA/CDRH for formal review.
11
Clinical development of a new Class III device is
typically divided into pilot and pivotal trial phases. The purpose of the pilot phase (starting with first clinical use) is to establish
safety and to assist in design of the pivotal trial. Pilot-phase testing is typically limited to fewer than 100 patients treated at a
few centers. The purpose of the pivotal trial is to generate data that defines patient populations in which use of the device is safe
and effective. The dialogue initiated during the pre-IDE meeting continues and intensifies between the FDA/CDRH and the company over the
specifics of the pivotal trial and includes the patient population, the control group against which the new device will be evaluated,
and the primary and secondary end points of the evaluation. For first-in-class devices, e.g. drug-eluting stents, where there are few
data regarding short- or long-term outcomes, the FDA/CDRH requires prospective randomized controlled studies. High profile devices that
require randomized data for approval are the exception rather than the rule. The vast majority of device clinical trials are case series
that carefully document product performance. Still more products are approved as tools.
When the FDA/CDRH has substantial data on the device
class metrics, comparisons may be made to historical data or objective performance criteria. When few data on existing standards are available,
the FDA typically requires randomized rather than single-arm studies, in which the new device is compared against concurrent controls
treated with current best medical practice. The comparison may be powered to show that the new treatment is superior to prior approaches,
or that it is non-inferior (equivalent or better) compared with a previously approved device in a new area.
The specifics regarding study design may have a profound
impact on the time and cost of bringing a new device to market. Though the primary mission of the FDA/CDRH is to ensure safety and effectiveness
of commercially available devices, when exerting regulatory oversight, the agency must balance its primary mission with the costs of introducing
new technologies to the clinical marketplace. This has been codified by the FDA Modernization Act and the FDA Modernization Act-II, which
require the agency to pursue the least burdensome means available to establish device safety and efficacy. The trial must
be conducted according to good clinical practices standards, with the approval of the local IRB at each participating center.
Every clinical site is federally mandated to have
an IRB responsible to ensure the protection of the rights, safety, and welfare of research subjects. Regulation of the IRB review of protocols
involving medical devices is under the purview of the FDA. The Office of Protection from Research Risks (OPRR) is responsible for oversight
regarding all human research and is in direct communication with the FDA/CDRH. Studies involving human subjects that do not involve products
regulated by the FDA fall under the direct purview of the OPRR. Both the FDA and the OPRR are in the Department of Health and Human Services.
Each IRB must meet standards for the composition, leadership, and processes set forth by that department. IRBs are subject to periodic
audits by the FDA to ensure that records and procedures are in compliance with regulations. The IRB process typically requires approximately
three months, but at times can take considerably longer.
The company must also negotiate agreements with each
clinical site addressing the many issues associated with the clinical trial. In addition to the study costs/reimbursement (per-patient
enrolled and overhead), these agreements typically include indemnification and the assignment of ownership rights of new discoveries (intellectual
property) made in the course of the study. The resources required at each center to perform the high-quality research necessary for a
PMA protocol are formidable. Pivotal studies required for a PMA application are typically large multicenter randomized trials and often
represent the largest commercial risk and expense in the device development process. In addition to obtaining an IDE from the FDA and
formally recruiting clinical sites, it also includes engaging a contract research organization (CRO), core laboratories, formation of
a data safety monitoring board (DSMB), and an executive committee.
Though there are many similarities in the regulatory
process in the United States and countries within the European Union, there are important differences that impact the time and cost associated
with the introduction of a new medical device. The European Union system relies heavily on notified bodies (NBs), which are independent
commercial organizations to implement regulatory control over medical devices. NBs have the ability to issue the CE mark, the official
marking required for certain medical devices. NBs are designated, monitored, and audited by the relevant member states via the competent
national authorities. Many functions performed by the FDA/CDRH
12
within the United States are performed by NBs, including
medical device certification, device type designation, assessment and verification of quality systems, and review of design dossiers for
high-risk devices. Currently, there are more than 50 active NBs within Europe. A company is free to choose any notified body designated
to cover the particular class of device under review. After approval, post-market surveillance functions are the responsibility of the
member state via the competent authority. NBs typically function in a closed manner, providing little visibility on criteria required
for approval. This dynamic allows for a high degree of variation as well as competition among NBs. As a result, NBs are perceived by industry
to be less bureaucratic organizations that can respond more quickly and efficiently than the FDA.
Criteria for approval of high-risk devices are different
in the European Union. To receive approval to market a Class III high-risk (and some Class II) device in the United States, the manufacturer
must demonstrate the device to be reasonably safe and effective, which typically requires a prospective, randomized controlled clinical
trial. To receive approval to market a device in the European Union, the manufacturer must demonstrate that the device is safe and that
it performs in a manner consistent with the manufacturers intended use. This difference has a profound impact on the size and scope
of the clinical studies for regulatory approval.
The demonstration of safety and efficacy for a new
medical device is a long, arduous, and expensive developmental path from early concept to introduction into clinical practice.
We will be subject to environmental and other rules
related to the handling of nitric oxide. We will be using very small testing quantities of nitric oxide and do not anticipate any material
issues in relation to nitric oxide as it relates to environmental or other regulatory issues.
In addition to the foregoing, our present and future
business may be subject to various laws and regulations relating to safe working conditions, clinical, laboratory and manufacturing practices,
the experimental use of animals and the use and disposal of hazardous or potentially hazardous substances, including radioactive compounds
and infectious disease agents, used in connection with our research, as well as national restrictions on technology transfer, and import,
export and customs regulations and similar laws and regulations in foreign countries. Due to the extensive regulatory requirements, management
does not anticipate any submittals for some time until the technology is more developed and tested in the lab. At such time as management
feels initial submittals are warranted, significant additional capital will need to be raised to proceed with even initial submittals.
As such, we believe any commercialization of our product is years away and we will continue to be reliant on loans and stock sales to
stay in business.
**Concentration of Customers**
Currently we do not have any customers and will not
have any customers until our product is through the development and testing stages and receives FDA approval.
**Patents, Trademarks, Licenses, Franchises, Concessions,
Royalty Agreements or Labor Contracts, including Duration**
Presently we have two patents approved and one patent
pending for our Nitric Oxide systems and we hope to file additional patents for our products which will help us build a strong IP portfolio
and value for our company and our shareholders. Our approved patents cover Gas Generator #62-014866 and our disposable delivery device.
Our patent pending covers Controlled Delivery of Medical gases using Diffusion Membrane #14529112. We are also pursuing a proprietary
protection strategy of our key formulations and methods for further strengthening the overall Intellectual Property portfolio. We have
no trademarks. We also have no franchises, concessions, royalty agreements or labor contracts.
13
**Research and Development Costs During the Last Two Fiscal Years**
We are currently expensing our costs under a general operating expense
category instead of capitalizing any research and development expenses.
**ITEM 1A. RISK FACTORS**
NU-MEDs operations are subject to a number
of risks including:
**Risk Factors Relating to NU-MEDs
Proposed Activities**
**We currently do not have the capital to fund
operations and are dependent on raising additional capital to stay in business.**
NU-MED is a medical device development
company focused on the development of systems for the delivery of nitric oxide. NU-MED is currently undercapitalized and is relying on
equity and debt investments to continue operations. We have identified the products we want to develop and market. We have moved forward
in the design and development stage with these products. Given that we will be producing a medical device, it may take years of testing
before we are able to start selling our product and we will need more capital infusions to get the product developed and to market. Investors
in NU-Med would be placing their money in a company with some developed products which are potentially years away from being able to sell
and with no support for the eventual commercial application or market for the product. Given the uncertainties facing the company, investors
should look to an investment in NU-MED as highly speculative and risky with a high probability of losing their entire investment.
**We are still in the product development
phase of our operations, so the ultimate success of our products is unknown.**
NU-MED is a development-stage business. NU-MED has
focused on the development of medical products which require extensive capital investment and can be a very lengthy process subject to
extensive regulatory approval. The ultimate success of NU-MED and its products is very uncertain. Investors will therefore be placing
their money in an undercapitalized company with no proven operations.
**Nitric oxide is a regulated chemical and is subject to extensive environmental
regulations related to its handling and disposal, which may increase our costs and subject us to environmental regulations.**
Although NU-MED operates as a research and development
company at this time and we use only small quantities of nitric oxide, we are still subject to the environmental and other workplace rules
related to the handling and disposal of nitric oxide. These rules require that we keep records of our handling and disposal of any nitric
oxide. Additionally, if we mishandle or do not dispose properly of the nitric oxide, we could be subject to fines and penalties. At this
time, we do not anticipate handling large quantities of nitric oxide and should not see substantial additional costs or contingencies
from our use of nitric oxide. However, as we expand our operations, the environmental and workplace rules related to the handling of nitric
oxide could increase our overall costs.
****
**We may incur significant costs complying with environmental laws and
regulations, and failure to comply with these laws and regulations could expose us to significant liabilities.**
Certain aspects of our business are subject to a variety
of federal, state and local laws and regulations governing the use, generation, manufacture, distribution, storage, handling, treatment
and disposal of materials. For example, high-pressure gas cylinders can be regarded as hazardous materials. Although we believe our safety
procedures for handling and disposing of these materials and waste products comply with these laws and regulations, we cannot eliminate
the risk of accidental injury or contamination from the use, manufacture, distribution, storage, handling, treatment or disposal of hazardous
materials. In the event of contamination or injury, or failure to comply with environmental, occupational health and safety and export
control laws and regulations, we could be held liable for any resulting damages and any such liability could exceed our assets and resources.
We do not maintain insurance for any environmental liability or toxic tort claims that may be asserted against us.
14
****
**We will need additional financing, which will potentially
dilute current investors, and we may not be able to obtain such financing.**
NU-MED intends to engage in product development that
will require substantial capitalization as we attempt to develop our products. Accordingly, NU-MEDs future success and profitability
may be based on our ability to obtain additional financing on favorable terms. Any additional financing may cause dilution to current
investors and there can be no assurance that any additional financing will be on terms that are favorable to NU-MED and our shareholders.
**The medical product business is highly competitive
and subject to extensive regulations, making it difficult and very expensive to bring new products into the marketplace.**
We face vigorous competition from companies throughout
the world, including multinational companies which are better financed and have more experience in medical product design. Most
of these competitors have greater resources than we do and may be able to respond to changing business and economic conditions more quickly
than us. Our ability to compete with these companies will be limited. Additionally, with extensive regulation and testing of medical
devices, it is extremely costly to bring a medical device to market and we may not be able to obtain the necessary capital to bring a
medical device to market. As such, an investment in the Company is very risky and could result in the loss of an investors entire
investment.
****
**Our success will be dependent on the ability of
management to develop medical devices.**
Our success depends on our ability to develop medical
products. With limited resources, we will be dependent on current management to be able to develop the medical devices. None of our current
management members has extensive experience developing medical products or bringing them to market. As such, investors will be placing
money with individuals with no proven success in developing and selling medical devices, thereby creating high risk of loss of an investors
entire investment in the Company.
****
**Our success depends, in part, on our key personnel.**
Our success depends, in part, on our ability to retain
our key personnel, including our executive officers and senior management team.Our management team has created our business model
and the initial focus on our first medical device. The unexpected loss of one or more of our key executives could adversely affect our
business. Our success also depends, in part, on our continuing ability to identify, hire, train and retain other highly qualified
personnel. Competition for these employees can be intense. We may not be able to attract, assimilate or retain qualified personnel
in the future, and our failure to do so could adversely affect our business.
****
**Our ability to commercialize pharmaceutical products
successfully may depend, in part, on the availability of reimbursement for our products from:**
* Government and health administration
authorities;
* Private health insurers; and
* Other third party payers, including
Medicare.
We cannot predict the availability of reimbursement
for health care products. Third-party payers, including Medicare, are challenging the prices charged for medical products and services.
Government and other third-party payers progressively are limiting both coverage and the level of reimbursement for new drugs. Third-party
insurance coverage may not be available to patients for any of our products.
15
The continuing efforts of government and third-party
payers to contain or reduce the costs of health care may limit our commercial opportunity. If government and other third-party payers
do not provide adequate coverage and reimbursement for any product we bring to market, doctors may not prescribe them, or patients may
ask to have their physicians prescribe competing treatments with more favorable reimbursement. In some foreign markets, pricing and profitability
of prescription pharmaceuticals are subject to government control. In the United States, we expect that there will continue to be federal
and state proposals for similar controls. In addition, we expect that increasing emphasis on managed care in the United States will continue
to put pressure on the pricing of pharmaceutical products. Cost control initiatives could decrease the price that we receive for any products
in the future. Further, cost control initiatives could impair our ability to commercialize our products and our ability to earn revenues
from this commercialization.
****
**We May Be Subject to Product Liability Claims if
People or Property Are Harmed by the Products We Sell.**
Some of the products we manufacture and sell may expose
us to product liability claims relating to personal injury or death caused by such products. Although we will maintain liability insurance,
we cannot be certain that our coverage will be adequate for liabilities actually incurred or that insurance will be available to us on
economically reasonable terms, or at all.
****
**Our auditors have indicated in their audit opinion
that there is a substantial doubt about our ability to continue as a going concern, which will affect our ability to raise capital or
borrow money.**
Our auditors have issued an audit opinion indicating
that there is a substantial doubt about our ability to continue as a going concern. As such, any potential investor or lender is unlikely
to be willing to provide additional capital or loans to us. Without additional capital, we will be unable to remain in business or to
execute on our business plan. Even if we are able to obtain additional capital, given the going concern modification, it
is likely investors would suffer substantial dilution to their investment.
****
**We are a small Company with a limited number of
employees, which makes it impossible to implement the internal controls that provide investors with assurances as to reporting accuracies.**
****
We have stated in Item 9A. Controls and Procedures
that because there are material weaknesses in internal controls due to the limited number of persons responsible for the recording and
reporting of financial information, the lack of separation of financial reporting duties, and the limited size of our management team
in general.
****
**General Risks Relating to Investors**
****
**We intend to take advantage of the disclosure requirements
of the JOBS Act provided for emerging growth companies, including not providing all of the accounting disclosure that other companies
will be required to provide, which may limit an investors ability to compare our financial statements with other companies.**
Under the JOBS Act, we can elect to not comply with
new or revised accounting standards which will allow us to delay the adoption of new or revised accounting standards that have different
effective dates for public and private companies. Until the standards are required for private companies, we will not be required to adopt
those standards. As such, our financial statements may not be comparable to those of companies that comply with public company effective
dates. This could affect an investors ability to evaluate our financial statements compared to other public companies. In addition
to the financial statements, as we qualify as a Smaller Reporting Company, the JOBS Act allows us to provide less disclosure
on certain issues, such as executive compensation, which could affect an investors ability to compare us to other companies.
****
**We do not intend to pay dividends in the near future.**
****
NU-MED has not paid, and does not plan to pay, dividends
in the foreseeable future, even if we were profitable. Earnings, if any, are expected to be used to expand operations, for research and
development and for general
16
corporate purposes, rather than to make distributions
to shareholders.
**Investors will not have cumulative voting
and will not be able to elect directors based on the percentages of ownership.**
****
Holders of common stock are not entitled to accumulate
their votes for the election of directors or otherwise. The present shareholders of NU-MED will be able to elect all of the directors
of NU-MED and effectively control NU-MEDs affairs, making it difficult for investors to be able to change management or the direction
of NU-MED. (See "DESCRIPTION OF SECURITIES.")
**We may issue more stock without shareholder input
or consent, which could dilute the book value of your investment.**
The board of directors has authority, without action
by or vote of the shareholders, to issue all or part of the authorized but unissued shares. In addition, the board of directors has authority,
without action by or vote of the shareholders, to fix and determine the rights, preferences, and privileges of the preferred stock, which
may be given voting rights superior to that of the common stock. Any issuance of additional shares of common stock or preferred stock
will dilute the ownership percentage of shareholders and may further dilute the book value of our shares. It is likely we will seek additional
capital in the future to fund operations. Any future capital will most likely reduce current shareholders percentage of ownership.
Additionally, with the board of directors having the ability to set the rights, preferences and privileges of the preferred stock the
board of directors, without shareholder approval, can create classes of stock which are superior to the common stock in both voting and
preferences, including dividend and liquidation preferences. As such, current and future holders of common stock may have less voting
power per share and dividend rights than subsequently issued preferred stock.
**A relatively small number of stockholders and managers
have significant influence over us,other stockholders will not be able to have a voice in the direction of the company, and stockholders
may disagree with the decisions of management.**
A small number of our stockholders and management,
acting together, will be able to exert significant influence over us through theirability to influence the election of directors
and all other matters that require action by our stockholders. The voting power of these individuals could have the effect of preventing
or delaying a change in control of our company which they oppose, even if our other stockholders believe it is in their best interests.
In addition, our executive officer has the ability to influence our day-to-day operations. These factors could negatively affect our company
and our stock price, as other investors may be unwilling to invest in a company with such a consolidation of control. Additionally, if
stockholders dislike the decisions of management, it will be difficult for stockholders to make changes to current management.
**The departure of certain key personnel could affect
the financial condition of NU-MED due to the loss of their expertise.**
Our business plan was developed by our officers and
will depend on their ability to design and create the initial models for our products. Without their expertise, it is unlikely we will
be able to complete the development and design of initial products. We do not have the funds, at this time, to hire additional personnel,
and without current management it is unlikely we will be able to obtain further funding. The loss of any member of management would severely
hinder our ability to develop our proposed products. A failure on our part to retain the services of these key personnel could have a
material adverse effect on our operating results and financial conditions. We do not maintain key man life insurance on any of our employees.
17
**ITEM 1C. CYBERSECURITY**
**Risk Management and Strategy**
****
Our cybersecurity policies, standards, processes and practices are based
on applicable laws and regulations and informed by industry standards and industry-recognized practices. Our strategy to assess, identify,
and manage material cybersecurity risks is focused on preserving the confidentiality, security, and availability of our information systems
and data. We implement security measures and processes to identify, prevent, and mitigate cybersecurity threats and to effectively respond
to cybersecurity incidents when they occur. Our cyber risk management includes: (1) enterprise risk management to identify top cybersecurity
risks; (2) vulnerability management to identify software vulnerabilities and risks related to compute infrastructure; (3) vendor risk
management to identify risks related to third parties and business partners; (4) privacy risk management to identify privacy risks in
our product and platforms and ensure regulatory compliance; and (5) security incident response to investigate, respond to, and mitigate
cyberthreats. As needed, we will engage third parties to identify risks in our underlying software and infrastructure, to provide threat
intelligence, and to assist in triaging, identifying, and responding to cyber threats.
In 2024, we did not identify any cybersecurity threats that have materially
affected or are reasonably likely to materially affect our business strategy, results of operations, or financial condition. However,
despite our efforts, we cannot eliminate all risks from cybersecurity threats or provide assurances that we have not experienced undetected
cybersecurity incidents.
**Governance**
****
Our Board of Directors maintains oversight of risks from cybersecurity
threats. Our Chief Financial Officer is assigned oversight of cybersecurity risks. Our Chief Financial Officer is responsible for ensuring
that management has processes in place designed to identify and evaluate cybersecurity risks to which the Company is exposed and to implement
processes and programs to manage cybersecurity risks and mitigate cybersecurity incidents.
**ITEM 2. PROPERTIES**
NU-MEDs corporate office is at 640 Belle Terre
Rd., Building E 2, Port Jefferson, NY 11777. Our R&D facility is located at 5718 W Dannon Way, Suite B, West Jordan, UT 84081. The
executive office arrangement provides us the flexibility to expand our corporate offices as needed, without being committed to long-term
overhead for office space we currently do not need. Our executive office and laboratory space are currently being provided to the Company
at no cost. Management believes these facilities will serve our purposes for at least the next twelve months.
**ITEM 3. LEGAL PROCEEDINGS**
None.
**ITEM 4. MINING SAFETY DISCLOSURE**
NU-MED has no mining operations.
**PART II**
****
**ITEM 5. MARKET FOR REGISTRANTS COMMON EQUITY,
RELATED STOCKHOLDER**
**MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES**
The Company's Common Stock is quoted on the over-the-counter
bulletin board and OTCQB under the symbol NUMD. The first sale of shares occurred in the third quarter of 2014. The Companys common
stock has traded sporadically and in low volume. Our closing stock price on January 31, 2025 was $0.0141 per share.
18
At March 31, 2025, the Company had approximately 155
shareholders of record. As of March 31, 2025, the Company had 83,548,469 shares of its Common Stock issued and outstanding.
**Transfer Agent**
NU-MEDs transfer agent is Issuer Direct Corporation,
One Glenwood Ave., Suite 1001, Raleigh, NC 27603; their telephone number is 919-481-4000.
Recent Issuances of Unregistered Securities
During 2023 the Company issued 2,200,000 shares of its restricted common
stock to officers and a director of the Company for which the Company recorded an expense of $41,800. The valuation was calculated based
on the $0.019 closing price of the stock on the date of grant.
**ITEM 6. [RESERVED]**
**ITEM 7. 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
Accounting policies are detailed in Note 2 of the
financial statements.
Plan of Operations
NU-MED is focused on the development of medical devices
with the first product aimed at the delivery of nitrogen oxide to patients. NU-MED believes the current delivery systems and supply of
nitrogen oxide are costly and creates an opportunity to develop nitric oxide delivery devices that can utilize cheaper delivery devices
for nitrogen oxide. In an effort to develop products, shortly after the founding of NU-MED, management raised initial capital to be able
to establish a lab and purchase equipment to work on the initial designs for a new medical device to deliver nitrogen oxide.
Our lab has been successfully equipped and we are
proceeding with the development of our proprietary product technology. Our technology is at the early development stage and management
plans are to concentrate on further improvement of our technology. Our budget requirements for the next year will be centered upon factors
relating to
19
the testing, research and enhancement with the intention
being to patent our formulation and design. Included in our budget for the next year is the costs of chemical standards, gases and equipment
we have projected we will need. Contained also within our budget are auditing costs and legal fees, which include patent filing expenses.
Projected costs to continue operation for the next year are $1,250,000 and may increase depending on the costs of patent applications,
submission of products to the FDA for approval and ongoing development work. At this time, we do not have the funds to operate at this
level and are seeking financing either through debt or equity. If we cannot raise the needed capital we may not be able to remain in business.
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. Rather than trying to raise a larger amount of capital upfront, which
management felt would result in higher dilution than otherwise would be required, management has chosen to raise capital in tranches as
product development progresses. With the first phase of establishing a lab and initial design completed and with prototype development
continuing, management anticipates having to seek additional capital in the near future to continue further development and testing for
FDA application. The exact amount of capital and the time frame to continue the development of the products is still unknown as management
continues to modify current designs during development. 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.
Liquidity and Capital Resources
At December 31, 2024, we had total assets of
$9,373 with current assets of $9,373 and total liabilities of $224,469. Our current assets consisted of cash in the amount of
$2,373. At December 31, 2023, we had assets of $13,456 with current assets of $13,456 and liabilities of $160,207. We currently have
sufficient cash to pay ongoing expenses for the next two months, after which we will have to rely on loans from shareholders to
cover expenses. Without additional capital, we will not be able to stay in business and move our business plan forward. We currently
have no commitments for the needed capital. Since we will not have a commercial product in the next twelve months, we will have 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 and potential loans from investors
and shareholders. If we are unable to raise additional capital, we will be forced to suspend operations until such capital can be
raised or go out of business. We cannot project the full costs to bring our proposed product to market or the timing of such
commercialization. Given that our product is in the medical field, testing is very expensive, and we will need additional capital
prior to completing the testing phase. Any refinement or modification of the product after the prototype is 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
For the year ended December 31, 2024, we had no
revenues, operating expenses of $63,331 and interest expense of $5,014,resulting in a net loss of $68,345. This compares to a net
loss for the year ended December 31, 2023 of $125,526. Operating expenses in 2024 decreased $57,195 over 2023 due primarily from the
reduction of stock-based compensation by $41,800, rent expense by $12,600 and professional fees of $5,362. The net loss in 2023 was
the result of $120,526 of operating expenses. We anticipate we will have operating losses for the foreseeable future and for the
losses to increase as we work to evaluate a potential merger. Additionally, we are preparing patent applications which will require
additional capital to pay for outside attorneys and consultants. We will be dependent on outside capital to support operations for
the foreseeable future and at this time do not have any commitments for additional capital.
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.
20
**ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA**
The financial statements of the Company are set forth immediately following
the signature page to this Form 10-K.
**ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS
ON**
**ACCOUNTING AND FINANCIAL DISCLOSURE**
The Company has had no disagreements with its independent
registered public accounting firms with respect to accounting practices or procedures or financial disclosure.
**ITEM 9A. CONTROLS AND PROCEDURES**
**Evaluation of Disclosure
Controls and Procedures**
****
Our management, including
our Principal Executive Officer and Principal Financial Officer, evaluated the effectiveness of our disclosure controls and procedures
as of the end of the period covered by this report. Based on that evaluation, our Principal Executive Officer and Principal Financial
Officer concluded that, for the reasons discussed below, our disclosure controls and procedures as of the end of the period covered by
this report were not effective for the reasons listed below. The disclosure controls and procedures ensure that all information required
to be disclosed by us in reports filed under the Exchange Act is (i)recorded, processed, summarized and reported within the time
periods specified in the SECs rules and forms and (ii)accumulated and communicated to our management, including our Principal
Executive Officer and Principal Financial Officer, as appropriate to allow timely decisions regarding disclosure. A controls system cannot
provide absolute assurance, however, that the objectives of the controls system are met, and no evaluation of controls can provide absolute
assurance that all control issues and instances of fraud, if any, within a company have been detected.
**Managements Annual
Report on Internal Control over Financial Reporting**
Our management is responsible
for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act).
Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted
in the United States.
Because of its inherent limitations,
internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective
can provide only reasonable assurance of achieving their control objectives.
Our management evaluated
the effectiveness of our internal control over financial reporting as of December 31, 2024. In making this assessment, our management
used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-
Integrated Framework - 2013. Based on this evaluation, our management concluded that, as of December 31, 2024, our internal controls over
financial reporting were not effective to provide reasonable assurances based on the above criteria.
The material weaknesses relate
to the limited number of persons responsible for the recording and reporting of financial information, the lack of separation of financial
reporting duties, and the limited size of our management team in general. We are in the process of evaluating methods of improving our
internal control over financial reporting, including the possible addition of financial reporting staff and the increased separation of
financial reporting responsibility, and intend to implement such steps as are necessary and possible to correct these material weaknesses.
21
This annual report does not
include an attestation report of the Companys registered public accounting firm regarding internal control over financial reporting.
Managements report was not subject to attestation by the Companys registered public accounting firm since the Company is
not an accelerated filer or large accelerated filed.
**Changes in internal control over financial reporting**
****
There have been no changes in internal control over
financial reporting that occurred during the last fiscal year that has materially affected, or is reasonably likely to materially affect,
the internal control over financial reporting.
**ITEM 9B. OTHER INFORMATION**
None
**ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS
THAT PREVENT INSPECTIONS.**
None; not applicable.
**PART III**
****
**ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE
GOVERNANCE**
The following table sets forth information with respect
to the officers and directors of NU-MED. NU-MEDs directors serve for a term of one year and thereafter until their successors have
been duly elected by the stockholders and qualified. NU-MEDs officers serve for a term of one year and thereafter until their successors
have been duly appointed by the Board of Directors and qualified.
|
Name |
Age |
Title | |
|
William Hayde |
60 |
CEO, Director | |
|
Keith Merrell |
79 |
Chief Financial Officer, Director | |
|
Jeffrey L. Robins |
76 |
Director | |
**William Hayde: President/CEO.**Mr. Hayde has been a Wall Street veteran for over 30 years,
concentrating on investment banking and institutional trading, retiring from that portion of the industry after a long, successful career.
Mr. Hayde has been the Managing Director of the Interim Opportunity Fund LLC and its advisor, Waterside Capital Advisors, Inc., since
March 2018. During 2013, Mr. Hayde was a co-founder and Executive Vice-President of Intercontinental Beverage Capital, Inc. (IBC).
IBC is a New York based merchant bank focused specifically on the beverage and consumer packed goods industries. Since January 2011 through
March 2018 he served as Registered Vice President of Investment Banking Network 1 Financial Securities, Inc. and has held the following
securities licenses: 4, 6, 7, 24, 55, 63 and 79. From 2002 through 2009 he was co-owner of Waterville Investment Research, which also
operated the hedge fund Waterville Investment Partners LLP. Mr. Hayde maintains seats on the advisory boards of multiple public and private
companies in the consumer and medical industries. From January 1997 through May 2010 he was head of investment banking for Brockington
Securities and directed the firms underwriting activities, private placements, and initiation of trading of newly listed securities.
Mr. Hayde received his B.A. degree from Stony Brook University.
**Keith L. Merrell**: **Chief Financial Offer and Principal Accounting Officer, Secretary and
Treasurer**. Mr. Merrell serves as our Chief Financial Officer, Secretary and Treasurer. Mr. Merrell draws on over 35 years of accounting
experience to manage our accounting functions and interface with our independent public accountants. He spent two years in the field of
public accounting and has served as Chief Financial Officer for four other public companies. He currently serves full-time as our Chief
Financial Officer and also serves as part-time CFO of another public company. His business career includes extensive experience in management,
sales and marketing, consulting, and merger and acquisition work. He graduated from Arizona State University with a B.S degree in
Accounting.
22
**Jeffrey L. Robins: Director**. Mr. Robins has 30 years of senior management experience in high
technology companies coupled with 15 years of engineering leadership experience. For the past 10 years, Mr. Robins has been a management
consultant for his private consulting company Robins Resource Associates. Through his consulting company, Mr. Robins served as COO of
Asta Ltd until 2017 Mr. Robins served as VP of Operations at TSCO CO., Inc. until 2006 where he was a member of the Executive Staff with
responsibilities for accelerated new product development and operations management. Mr. Robins has extensive global experience, including
Operations Senior Director at Fujitsu Microelectronics, where he was responsible for foundry services, product development and two wafer
fabrication plants from start up to full production and ultimately having P&L responsibility for a $450 million operation. He was
Fabrication Director of Operations at International Rectifier and has held various positions at Intel and AMD. He is a past president
of the Oregon Semiconductor Association. Mr. Robins holds a B.S. in Pharmacy from Idaho State University, a B.S. in Political Science
from Weber State University and an Engineering Management Certificate from Idaho State University.
None of our officers and directors has filed for bankruptcy,
been convicted in a criminal proceeding or been the subject of any order, judgment, or decree permanently, temporarily, or otherwise limiting
activities (1) in connection with the sale or purchase of any security or commodity or in connection with any violation of Federal or
State securities laws or Federal commodities laws, (2) engaging in any type of business practice, or (3) acting as a futures commission
merchant, introducing broker, commodity trading advisor, commodity pool operator, floor broker, leverage transaction merchant, any other
person regulated by the Commodity Futures Trading Commission or an associated person of any of the foregoing, or as an investment adviser,
underwriter, broker or dealer in securities, or as an affiliated person, director or employee of an investment company, bank, savings
and loan association or insurance company, or engaging in or continuing any conduct or practice in connection with such activity.
**Family Relationships**
The officers/directors have no family relationships
to any other related parties.
COMPLIANCE WITH SECTION 16(A) OF THE EXCHANGE ACT
The Company believes all forms were filed.
**ITEM 11. EXECUTIVE COMPENSATION**
****
**SUMMARY COMPENSATION TABLE**
The following tables set forth certain summary information
concerning the compensation paid or accrued for each of the Company's last two completed fiscal years to the Company's or its principal
subsidiaries chief executive officer and each of its other executive officers that received compensation during such period (as
determined at December 31, 2024, the end of the Company's last completed fiscal year):
****
23
**Summary Compensation Table**
|
Name and
Principal
Position |
Year |
Salary |
Bonus |
Stock
Awards |
Option
Awards |
Non-Equity
Incentive Plan
Compensation |
All
Other Compensation |
Total | |
|
William Hayde |
2024 |
$-- |
-- |
$- |
-- |
-- |
-- |
$-- | |
|
CEO |
2023 |
-- |
-- |
19,000 |
-- |
-- |
-- |
19,000 | |
|
|
|
|
|
|
|
|
|
| |
|
Jeffrey L.Robins |
2024 |
$-- |
-- |
-- |
-- |
-- |
-- |
$
-- | |
|
Director |
2023 |
-- |
-- |
$3,800 |
-- |
-- |
-- |
3,800 | |
|
|
|
|
|
|
|
|
|
| |
|
Keith L. Merrell |
2024 |
$-- |
-- |
$-- |
-- |
-- |
-- |
$-- | |
|
CFO |
2023 |
-- |
-- |
19,000 |
-- |
-- |
-- |
19,000 | |
________________
Mr. Hayde joined the Company as President/CEO in September
2022.
Mr. Robins relinquished his position as President/CEO
in September 2022 but continues as a Director.
Mr. Merrell joined the Company in August 2015.
Outstanding Equity Awards at Fiscal Year-End
****
We had no outstanding equity awards at fiscal year-end 2024 or
2023.
Option/Stock Appreciation Rights (SAR) Grants in
Last Fiscal Year
In fiscal 2024 and 2023, there were no stock options
or SAR Grants.
Stock Option Exercise
In fiscal 2024 and 2023, none of the named executives
exercised any options to purchase shares of common stock.
Long-Term Incentive Plan (LTIP)
There were no awards granted during fiscal year 2024
or 2023 under a long-term incentive plan.
Board of
Directors Compensation
Each director may be paid his expenses, if any, for
attendance at each meeting of the board of directors and may be paid a stated salary as director or a fixed sum for attendance at each
meeting of the board of directors or both. No such payment shall preclude any director from serving the corporation in any other capacity
and receiving compensation therefrom. We did not compensate our directors for service on the Board of Directors during fiscal 2024. During
2023 the President and CFO were each granted 1,000,000 shares of restricted common stock and a director was granted 200,000 shares of
restricted common stock for their service.
No other compensation arrangements exist between NU-MED
and our officers and directors.
Employment Contracts and Termination of Employment
and Change-in-Control Arrangements
The Company has employment contracts with our executive
officers. Outside of these agreements, no other compensatory plan or arrangements exist between the Company and our executive officers
that results, or will result from the resignation, retirement or any other termination of such executive officers employment with
the Company, or from a change in control.
24
Report on Executive Compensation
The Board of Directors determines the compensation
of NU-MEDs executive officer and president and sets policies for, and reviews with the chief executive officer and president, the
compensation awarded to the other principal executives, if any. The compensation policies utilized by the Board of Directors are intended
to enable NU-MED to attract, retain and motivate executive officers to meet our goals using appropriate combinations of base salary and
incentive compensation in the form of stock options. Generally, compensation decisions are based on contractual commitments, if any, as
well as corporate performance, the level of individual responsibility of the particular executive and individual performance. At this
time the Board of Directors has determined no compensation is warranted to the officers and directors until such time as a merger is completed
or business operation is established. At such time executive compensation on an ongoing basis will be reviewed.
Code of Ethics
We do not have a code of ethics.
Option Plans
NU-MED has no option plans and no outstanding options.
Board of Directors Interlocks and Insider Participation in Compensation
Decisions
No such interlocks existed nor were such decisions
made during fiscal years 2024 or 2023.
Termination of Employment and Change of Control Arrangement
There are no compensatory plans or arrangements, including
payments to be received from the Company, with respect to any person named in cash compensation set out above, which would in any way
result in payments to any such person because of his resignation, retirement, or other termination of such person's employment with the
Company or its subsidiaries, or any change in control of the Company, or a change in the person's responsibilities following a changing
in control of the Company.
**ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND
MANAGEMENT AND RELATED STOCKHOLDER MATTERS**
**Security Ownership of Certain Beneficial Owners:**
The following table sets forth certain information
as of March 31, 2025, with respect to the beneficial ownership of the Companys common stock by each director of the Company and
each person known by the Company to be the beneficial owner of more than 5% of the Companys outstanding shares of Common Stock.
At March 31, 2025, there were 83,548,469 shares of common stock outstanding.
For purposes of this table, information as to the
beneficial ownership of shares of common stock is determined in accordance with the rules of the Securities and Exchange Commission and
includes general voting power and/or investment power with respect to securities. Except as otherwise indicated, all shares of our common
stock are beneficially owned, and sole investment and voting power is held, by the person named. For purposes of this table, a person
or group of persons is deemed to have beneficial ownership of any shares of common stock which such person has the right to acquire within
60 days after the date hereof. The inclusion herein of such shares listed beneficially owned does not constitute an admission of beneficial
ownership.
25
|
|
Amountof |
Percentage of Outstanding | |
|
Name and Address of Beneficial Owner |
Beneficial Owner |
Common stock | |
|
Principal Shareholders |
|
| |
|
Jeffrey L. Robins
2152 W. Bryce Drive
Kaysville, Utah 84037
|
5,200,000 |
6.22% | |
|
William Hayde
640 Belle Terre Rd Blvd E 2
Port Jefferson, NY 11777
|
3,200,000 |
3.83% | |
|
Keith L. Merrell |
4,181,250 |
5.00% | |
|
1240 Mueller Park Rd. |
|
| |
|
Bountiful, UT 84010 |
|
| |
|
|
|
| |
|
WLP Trust
455 East 500 South, Suite 201
Salt Lake City, Utah 84111
|
25,050,000 |
29.98% | |
|
Officers and Directors |
|
| |
|
William Hayde |
3,200,000 |
3.83% | |
|
Jeffrey L. Robins |
5,200,000 |
6.22% | |
|
Keith Merrell |
4,181,250 |
5.00% | |
|
Director and executive officer of the |
|
| |
|
Company (3 individuals) |
12,581,250 |
15.05% | |
_________________________________
WLP Trust is owned and controlled by Wendy
Smith, the widow of Karl Smith, who owned SCS. SCS was owed $230,100 in principal and $118,542 in accrued interest. The Company was
notified that SCS wished to convert the notes and accrued interest to shares of restricted common stock. Subsequent to providing the
notice of conversion Mr. Smith died without a will. After his estate had been through probate the Company was given instructions to
issue 25,000,000 shares to WLP Trust, 2,000,000 shares to Roger Gill and 1,000,000 shares to Henry Smith. Prior to the issuance of
these shares WLP Trust was the holder of 50,000 shares of stock.
**Control by Existing Stockholders**
Current management owns 15.05% of the issued and
outstanding shares of common stock. It is likely they will be able to control NU-MED due to their present control of the Board of
Directors and will be in a position to recommend to dissolve, merge or sell the assets of NU-MED, and generally, to direct the
affairs of NU-MED.
**Dividends**
We have not declared any cash dividends with respect
to our common stock, and do not intend to declare dividends in the foreseeable future. Our future dividend policy cannot be ascertained
with any certainty. There are no material restrictions limiting, or that are likely to limit, our ability to pay dividends on our securities.
26
**Securities Authorized for Issuance under Equity
Compensation Plans**
|
Plan Category |
Number of Securities to be issued upon exercise of outstanding options, warrants and rights |
Weighted-average exercise price of outstanding options, warrants and rights |
Number of securities remaining available for future issuance under equity compensation plans excluding securities reflected in column (a) | |
|
|
(a) |
(b) |
(c) | |
|
Equity compensation plans approved by security holders |
None |
None |
None | |
|
Equity compensation plans not approved by security holders |
None |
None |
None | |
|
Total |
NA |
NA |
NA | |
****
**ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR**
**INDEPENDENCE.**
**Transactions with Officers and Directors**
On September 12, 2022 the Company entered into employment
agreements with Mr. Hayde, its President/CEO and Mr. Merrell, its CFO. The employment agreements provide for no salary until such time
as adequate funds are available, at which time the salaries will be determined by the Board of Directors.
During the year ended December 31, 2023 the Company
issued 2,200,000 shares of restricted common stock to its officers and directors. The Company recorded a stock-based compensation charge
of $41,800, the valuation being based on the closing price of $0.019 per share on the date of the grant.
Except as set forth above, there were no material
transactions, or series of similar transactions, during our Companys last five fiscal years, or any currently proposed transactions,
or series of similar transactions, to which we or any of our subsidiaries was or is to be a party, in which the amount involved exceeded
the lesser of $120,000 or one percent of the average of our total assets at year-end for the last three completed fiscal years and in
which any promoter or founder of ours or any member of the immediate family of any of the foregoing persons, had an interest.
At this time, we have three directors, none of which
qualify as independent. One of our directors is a founder and major shareholder of NU-MED. Additionally, given the limited size of our
board of directors, we have not set up any committees of the board of directors such as compensation, audit or nominating committees.
As our operations expand, we hope to be able to add outside directors and set up these committees, but at this time, do not know when
we will be able to add additional directors and set up such committees.
Transactions with Promoters
There have been no transactions between the Company and promoters during
the last fiscal year.
**ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES**
The Company has selected Fruci & Associates II, PLLC as its independent
public accounting firm, effective with the audit of our 2024 financial results. Expected fees to be paid are:
1) Audit Fees - The aggregate fees incurred for professional services
rendered by our principal accountant for the audit of our annual financial statements ending December 31, 2023 was $23,861. It is
anticipated that professional
27
fees rendered by our principal account for the audit of our financial statements
ending December 31, 2024 will be approximately $16,000 and $3,750 for the review of each of our quarterly financial statements during
the initial three quarters of 2024.
2) Audit-Related Fees. $0 and $0.
3) Tax Fees. $0 and $0.
4) All Other Fees. $0.
****
**PART IV**
****
**ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES**
(a)(1) FINANCIAL STATEMENTS. The following financial statements are
included in this report:
|
Title of Document |
Page | |
|
|
| |
|
Reports of Independent Registered Public Accounting Firm |
32 | |
|
Balance Sheets |
33 | |
|
Statements of Operations |
34 | |
|
Statements of Stockholders' Deficit |
35 | |
|
Statements of Cash Flows |
36 | |
|
Notes to Financial Statements |
37 | |
(a)(2) FINANCIAL STATEMENT SCHEDULES. The following financial
statement schedules are included as part of this report:
None.
(a)(3) EXHIBITS. The following exhibits are included as part of this
report:
|
Exhibit Number |
SEC Reference
Number |
Title of Document |
Location | |
|
Item 3Articles of Incorporation and Bylaws | |
|
3.01 |
3 |
Articles of Incorporation |
Incorporated by reference* | |
|
|
|
|
| |
|
3.02 |
3 |
Bylaws |
Incorporated by reference* | |
|
|
|
|
| |
|
Item 4Instruments Defining the Rights of Security Holders | |
|
|
|
|
| |
|
4.01 |
4 |
Specimen Stock Certificate |
Incorporated by reference* | |
|
|
|
|
| |
|
10.01 |
10 |
Consulting Contract - SCS |
Incorporated by reference** | |
|
|
|
|
| |
|
10.02 |
10 |
Amended Promissory Note - SCS |
Incorporated by reference*** | |
|
|
|
|
| |
|
10.03 |
10 |
Promissory Note - SCS |
Incorporated by reference*** | |
|
|
|
|
| |
|
31.01 |
31 |
CEO certification |
This filing | |
|
|
|
|
| |
|
31.02 |
31 |
CFO certification |
This filing | |
|
|
|
|
| |
|
32.01 |
32 |
CEO certification |
This filing | |
|
|
|
|
| |
|
32.02 |
32 |
CFO certification |
This filing | |
28
101. INS XBRL Instance
101. XSD XBRL Schema
101. CAL XBRL Calculation
101. DEF XBRL Definition
101. LAB XBRL Label
101. PRE XBRL Presentation
*The exhibits were filed with the original Form 10 filed by NU-MED on December
10, 2012, file number 000-54808.
**The consulting contract was filed on Form 8-K dated January 7, 2014 and
filed on January 8, 2014.
***Amended note filed with the Form 8-K dated September 27, 2013, and filed
on October 1, 2013.
29
**SIGNATURES**
Pursuant to the requirements of Section 13 or 15(d)
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.
|
March 31, 2025 |
By: /s/ William Hayde | |
|
|
William Hayde, CEO, Principal Executive | |
|
March 31, 2025 |
By: /s/ Keith L. Merrell | |
|
|
Keith L. Merrell, CFO/Principal Accounting Officer | |
In accordance with Section 12 of the Securities Exchange
Act of 1934, the Registrant caused this registration statement to be signed on its behalf by the undersigned in the capacities and on
the dates stated.
|
Signature |
Title |
Date | |
|
|
|
| |
|
/s/ William Hayde |
Director, CEO, President |
March 31, 2025 | |
|
William Hayde |
|
| |
|
|
|
| |
|
/s/ Jeffrey L. Robins |
Director |
March 31, 2025 | |
|
Jeffrey L. Robins |
|
| |
|
|
|
| |
|
/s/ Keith L. Merrell |
Director, CFO |
March 31, 2025 | |
|
Keith L. Merrell |
|
| |
30
**Nu-Med Plus, Inc.**
Financial Statements
December 31, 2024 and 2023
**Table of Contents**
****
****
|
|
|
Page No. | |
|
|
|
| |
|
Reports of Independent Registered Public Accounting Firms |
|
32 | |
|
|
|
| |
|
Balance Sheets |
|
33 | |
|
|
|
| |
|
Statements of Operations |
|
34 | |
|
|
|
| |
|
Statements of Stockholders' Deficit |
|
35 | |
|
|
|
| |
|
Statements of Cash Flows |
|
36 | |
|
|
|
| |
|
Notes to the Financial Statements |
|
37 | |
|
|
|
| |
31
****
****
**REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM**
To the Board of Directors and Shareholders of Nu-Med
Plus, Inc.
**Opinion on the Financial Statements**
We have audited the accompanying balance sheets
of Nu-Med Plus, Inc.(the Company) as of December 31, 2024 and 2023, and the related statements of operations, statements
of stockholders deficit, and cash flows for each of the years in the two-year period ended December 31, 2024, and the related notes
(collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects,
the financial position of the Company as of December 31, 2024 and 2023 and the results of its operations and its cash flows for each of
the years in the two-year period ended December 31, 2024, in conformity with accounting principles generally accepted in the United States
of America.
**Going Concern**
The accompanying financial statements
have been prepared assuming that the Company will continue as a going concern. As discussed in Note 3 to the financial statements,
the Company has incurred losses since inception, has negative cash flows from operating activities and an accumulated deficit. These
factors, among others, raise substantial doubt about the Companys ability to continue as a going concern. Managements
plans in regard to these matters are also described in Note 3. The financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
**Basis for Opinion**
These financial statements are the responsibility
of the Companys management. Our responsibility is to express an opinion on the Companys financial statements based on our
audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are
required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and
regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Companys
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to
assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
**Critical Audit Matters**
Critical audit matters are matters arising
from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee
and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,
subjective, or complex judgments. We determined that there were no critical audit matters.
*/s/ Fruci & Associates II, PLLC - PCAOB ID #05525
We have served as the Companys auditor since
2023.
Spokane, Washington
March 31, 2025
32
****
**NU-MED PLUS, INC.**
**Balance Sheets**
|
|
|
|
|
December 31, |
December 31, | |
|
|
|
|
|
2024 |
2023 | |
|
ASSETS |
|
|
|
| |
|
Current assets |
|
|
| |
|
|
Cash |
|
$2,373 |
$6,806 | |
|
|
Prepaid expense |
|
7,000 |
6,650 | |
|
|
|
Total current assets |
|
9,373 |
13,456 | |
|
|
|
Total assets |
|
$9,373 |
$13,456 | |
|
|
|
|
|
|
| |
|
LIABILITIES AND STOCKHOLDERS' DEFICIT |
|
|
| |
|
Current liabilities |
|
|
| |
|
|
Accounts payable |
|
$43,040 |
$8,089 | |
|
|
Accounts payable related party |
|
66,710 |
46,118 | |
|
|
Note payable |
|
100,000 |
100,000 | |
|
|
Accrued expense |
|
14,719 |
6,000 | |
|
|
|
Total current liabilities |
|
224,469 |
160,207 | |
|
Long-term liabilities |
|
- |
- | |
|
Total liabilities |
|
224,469 |
160,207 | |
|
Commitments and contingencies |
|
- |
- | |
|
Stockholders' deficit |
|
|
| |
|
|
Preferred stock; $0.001 par value per share; 10,000,000 authorized; -0- and -0- shares issued and outstanding, as of December 31, 2024 and 2023, respectively. |
|
- |
- | |
|
|
Common stock; $0.001 par value per share; 90,000,000 authorized; 83,548,469 and 83,548,469 shares issued and outstanding, as of December 31, 2024 and 2023, respectively. |
|
83,549 |
83,549 | |
|
|
Additional paid-in capital |
|
9,594,687 |
9,594,687 | |
|
|
Accumulated deficit |
|
(9,893,332) |
(9,824,987) | |
|
|
|
Total stockholders' deficit |
|
(215,096) |
(146,751) | |
|
|
|
Total liabilities and stockholders' deficit |
|
$9,373 |
$13,456 | |
|
|
|
|
|
|
|
| |
*
**
**
**
**
**
**
**
**
**
*The accompanying notes are an integral part of these
financial statements.*
33
**NU-MED PLUS, INC.**
**Statements of Operations**
|
|
|
|
|
Year ended |
Year ended | |
|
|
|
|
|
December 31, 2024 |
December 31, 2023 | |
|
Revenue |
|
$- |
$- | |
|
|
|
|
|
|
| |
|
Operating expenses |
|
|
| |
|
|
General and administrative expense |
|
34,324 |
27,557 | |
|
|
Payroll expense |
|
- |
41,800 | |
|
|
Rent expense |
|
300 |
12,900 | |
|
|
Professional and consulting fees |
|
28,707 |
38,269 | |
|
|
|
Total operating expenses |
|
63,331 |
120,526 | |
|
|
|
|
|
|
| |
|
|
|
Operating loss |
|
(63,331) |
(120,526) | |
|
|
|
|
|
|
| |
|
Other income (expense) |
|
|
| |
|
|
Interest expense |
|
(5,014) |
(5,000) | |
|
|
|
Total other income (expense) |
|
(5,014) |
(5,000) | |
|
|
Loss before income taxes |
|
(68,345) |
(125,526) | |
|
|
Income tax expense |
|
- |
- | |
|
|
|
|
|
| |
|
|
|
Net loss |
|
$(68,345) |
$(125,526) | |
|
|
|
|
|
| |
|
|
Basic and diluted earnings per share |
|
$(0.00) |
$(0.00) | |
|
|
Weighted average common shares
outstanding basic and diluted |
|
83,548,469 |
81,673,948 | |
|
|
|
|
|
| |
|
|
|
|
|
| |
**
**
**
**
**
**
**
**
**
**
**
**
**
**
*The accompanying notes are an integral part of these
financial statements.*
34
**NU-MED PLUS, INC.**
**Statements of Stockholders Deficit**
|
|
Preferred Stock |
Common Stock |
Additional Paid-In |
Accumulated |
| |
|
|
Shares |
Amount |
Shares |
Amount |
Capital |
Deficit |
Total | |
|
Balance, December 31, 2022 |
- |
$- |
81,348,469 |
$81,469 |
$9,555,087 |
$(9,699,461) |
$ (63,025) | |
|
Common Stock issued for services |
- |
- |
2,200,000 |
2,200 |
39,600 |
- |
41,800 | |
|
Net loss for the year ended December 31, 2023 |
- |
- |
- |
- |
- |
(125,526) |
(125,526) | |
|
Balance, December 31, 2023 |
- |
$- |
83,548,469 |
$ 83,549 |
$9,594,687 |
$(9,824,987) |
$(146,751) | |
|
Net loss for the year ended December 31, 2024
|
- |
- |
- |
- |
- |
(68,345) |
(68,345) | |
|
Balance, December 31, 2024 |
- |
$- |
83,548,469 |
$ 83,549 |
$ 9,594,687 |
$(9,893,332) |
$ (215,096) | |
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
| |
****
****
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
*The accompanying notes are an integral part of these
financial statements.*
35
**NU-MED PLUS, INC.**
**Statements of Cash Flows**
|
|
|
|
Year ended December 31, 2024 |
Year ended December 31, 2023 | |
|
Cash flows from operating activities: |
|
| |
|
|
Net income (loss) |
$(68,345) |
$(125,526) | |
|
|
Adjustment to reconcile net income (loss) to net cash used in operating activities: |
|
| |
|
|
|
Stock-based compensation |
- |
41,800 | |
|
|
|
Prepaid expenses |
(350) |
(300) | |
|
|
|
Accounts payable |
34,951 |
897 | |
|
|
|
Related party payables |
20,592 |
11,740 | |
|
|
|
Accrued expense |
8,719 |
5,000 | |
|
|
|
Net cash used in operating activities |
(4,433) |
(66,389) | |
|
|
|
|
|
| |
|
Cash flows from financing activities |
- |
- | |
|
|
|
Net cash provided by financing activities |
- |
- | |
|
|
|
|
|
| |
|
Cash flows from investing activities |
|
| |
|
|
|
Net change provided by investing activities |
- |
- | |
|
Net change in cash |
(4,433) |
(66,389) | |
|
Cash at beginning of period |
6,806 |
73,195 | |
|
|
|
|
|
| |
|
Cash at end of period |
$2,373 |
$ 6,806 | |
|
Supplemental schedule of cash flow information |
|
| |
|
|
Cash paid for interest |
$- |
$- | |
|
|
Cash paid for income taxes |
$- |
$- | |
|
|
|
| |
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
**
*The accompanying notes are an integral part of these
financial statements.*
36
**NU-MED PLUS, INC.**
**Notes to the Financial Statements**
**For the Years Ended December 31, 2024 and 2023**
NOTE 1 - ORGANIZATION AND DESCRIPTION OF BUSINESS
Nu-Med Plus, Inc. (or the Company) is
an emerging growth early-stage medical device company principally engaged in the design, innovation, development, enhancement and commercialization
of beginning, early, and selective later-stage quality medical devices. The Company's immediate focus was on the development of Nitric
Oxide delivery devices, including a hospital unit, a clinical unit to be used in doctors offices and extended care facilities,
a portable unit and a single use disposable unit. We were also developing a powder formulation to generate Nitric Oxide that is 99% pure,
with a one-year shelf life, a "desktop" generator device with controls plus safety monitors built in that delivers inhaled Nitric
Oxide to replace expensive pressurized canisters and a compact mobile rechargeable device to deliver inhaled Nitric Oxide gas. Development
on these devices was suspended when adequate funding was not available to support their continued development. We are currently working
to locate a merger partner that will be able to fund the final development of these products. The Company is incorporated in Utah.
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
a. Basis of Presentation
The Companys financial statements are prepared
in accordance with accounting principles generally accepted in the United States of America. In the opinion of management, all adjustments
which are necessary for a fair statement of the results for fiscal years have been included.
b. 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.
c. 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.
d. 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 $500, for new assets or that increase the useful life of existing assets are capitalized. Depreciation is
computed using the straight-line method. The lives over which the fixed assets are depreciated are five to seven years.
e. Fair Value
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:
37
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.
f. Earnings per Share
The computation of basic 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 includes shares subscribed
but unissued in its calculation of earnings per share if years it achieves a net profit, but does not included them in the calculation
is years of a net loss, as their inclusion would be antidilutive.
|
|
For the year ended December 31, 2024 |
For the year ended December 31, 2023 | |
|
|
|
| |
|
Net loss (numerator) |
$(68,345) |
$(125,526) | |
|
Shares (denominator) |
83,548,469 |
81,673,948 | |
|
Net earnings per share amount - basic |
$(0.00) |
$(0.00) | |
|
Shares (denominator) |
83,548,469 |
81,673,948 | |
|
Net earnings per share amount - diluted |
$(0.00) |
$(0.00) | |
Diluted earnings per share is computed using the weighted
average number of common shares plus dilutive common share equivalents outstanding during the period. As of December 31, 2024 and 2023
there were -0- and -0-, respectively, potential dilutive shares that needed to be considered as common share equivalents.
g. 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.
h. 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.
i. 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.
38
j. Segment Reporting
In November 2023, the Financial Accounting Standard
Board (FASB) issued Accounting Standard Update (ASU) 2023-07, *Segment Reporting (Topic 280): Improvements
to Reportable Segment Disclosures (ASU 2023-07),*which is intended to improve reportable segment disclosure requirements,
primarily through additional and more detailed information about a reportable segments expenses. The update improves the reportable
segment disclosure requirements by requiring all entities to disclose significant segment expenses that are regularly provided to the
chief operating decision maker (CODM),report other segment items (segment revenue less the significant expenses disclosed
and profit or loss) by reportable segment, title and position of the CODM and an explanation of how the CODM uses the reported measure
of segment profit or loss in assessing segment performance and deciding how to allocate resources. Additionally, ASU 2023-07 requires
that if the CODM uses more than one measure of a segments net income or loss in assessing segment performance and deciding how
to allocate resources, the entity may report one or more of these additional measures. We operate as one operating segment, and therefore
one reportable segment. We manage business activities on a consolidated basis. Our determination that we operate as a single operating
segment is consistent with the financial information regularly reviewed by our CODM. Our CODM is the Chief Executive Officer.
k. Recent Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, *Income
Statement Reporting Comprehensive Income Expense Disaggregation Disclosures*, which requires additional disclosure
of certain costs and expenses within the notes to the financial statements. The new standard is effective for annual periods beginning
after December 15, 2026 and interim periods beginning in the first quarter of fiscal year 2028. Early adoption is permitted. The new standard
is to be applied on a prospective basis, but retrospective application is permitted. The Company is evaluating the impact, if any, of
adopting ASU 2024-03.
The Company has reviewed all other recently issued,
but not yet adopted, accounting standards in order to determine their effect, if any, on its consolidated 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 3 - GOING CONCERN
The Company has incurred losses since inception, has
negative cash flows from operating activities, and an accumulated deficit. The Company anticipates that the funds on hand as of December
31, 2024, will fund its reduced level of operations through approximately February 2025, but will not be sufficient to successfully prosecute
its business plan. Funding through the sale of equity capital and short-term related parties and other shareholder loans in order to meet
the planned expenditures for development, operations, and administrative costs over the next 12 months will be required. Planned expenditures
are approximately $1,250,000 for 2025. These factors raise substantial doubt about the Company's ability to continue as a going concern
for a period of one year from the issuance of these financial statements. The Company has begun the process of arranging for additional
necessary funding and currently retains consultants for that purpose. Management will adjust any salaries and expenditures based on the
need for successful continuous operations. If plans to obtain further financing prove to be insufficient to fund operations, continued
viability could be at risk. The accompanying financial statements do not include any adjustments that might result from the outcome of
this uncertainty.
| | |
| | |
NOTE 4 - PROPERTY AND EQUIPMENT
Property and equipment and related accumulated depreciation
consisted of the following at December 31, 2024, and December 31, 2023:
|
|
December 31, 2024 |
|
December 31, 2023 | |
|
|
|
|
| |
|
Computer and office equipment |
$83,893 |
|
$83,893 | |
|
Accumulated depreciation |
(83,893) |
|
(83,893) | |
|
|
|
|
| |
|
Total Property and Equipment |
$- |
|
$- | |
Depreciation expense for the years ended December
31, 2024 and 2023 was $-0- and $-0-, respectively.
NOTE 5 - PREFERRED STOCK
On October 19, 2011, the Company filed Articles of
Incorporation with the State of Utah so as to authorize 10,000,000 shares of preferred stock having a par value of $0.001 per share. At
December 31, 2024 and 2023 there are -0- shares of preferred stock issued and outstanding.
NOTE 6 - COMMON STOCK
****
On October 19, 2011, the Company filed Articles of
Incorporation with the State of Utah so as to authorize 90,000,000 shares of common stock having a par value of $0.001 per share. At December
31, 2024 and 2023 there are 83,548,469 shares of preferred stock issued and outstanding.
****
Common Stock Issued to Officers:
The Company issued no shares of restricted common
stock to officers and directors in the year ended December 31, 2024.
During the year ended December 31, 2023 the Company
issued 2,200,000 shares of restricted common stock to its officers and directors. The Company recorded a stock-based compensation charge
of $41,800, the valuation being based on the closing price of $0.019 per share on the date of the grant.
Employment and Consulting Agreements
In September 2022 the Company entered into employment
agreements with Mr. William Hayde and Mr. Keith Merrell and a consulting agreement with Hanover International. Under each of the agreements
there is a provision that provides for the issuance of 500,000 shares of preferred stock. As of the current date no terms have been established
for the preferred stock or its conversion to common stock and no Certificate of Designation has been filed. The issuance of the preferred
shares is subject to approval.
NOTE 7 - COMMITMENTS AND CONTINGENCIES
Operating Lease Obligations
The Company currently has no lease obligations related
to office space.
NOTE 8- RELATED PARTY TRANSACTIONS
Accounts Payable
During the years ended December 31, 2024 and
2023 the Chief Financial Officer provided to the Company $20,592
39
and $11,740, respectively, for the payment of operating
expenses, bringing the total funds he has provided the company to $66,231. A director of the company also provided $478 for operating
expenses during 2023. The total payable to officers and directors at December 31, 2024 is $66,710.
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.
Stock Grant
On November 7, 2023 the Company approved the issuance
of 2,200,000 shares of restricted common stock to its officers in recognition of services performed, for which they had received no monetary
renumeration. Of the shares issued, the President/CEO and Chief Financial Officer received 1,000,000 shares each and 200,000 shares were
issued to the former President/CEO.
NOTE 9 - CONVERTIBLE PROMISSORY NOTE
On September 11, 2022 the Board of Directors
authorized Mr. Hayde to issue a convertible note in the amount of $100,000 to Your Space, Inc. The note bears interest at the rate
of 5% per annum and has a term date of December 31, 2023. The note had an original due date of December 31, 2023. The parties have
mutually agreed to extend the due date to December 31, 2025. The Company may pay the principal and accrued interest at any time
prior to the due date. The holder of the note may choose to convert the principal and accrued interest of the note to shares of
common stock by providing notice of their intent to convert. The conversion rate provides for a 20% discount to the share price
established in a liquidity event, such event defined as the trading of the stock on a major stock exchange. Should the note be
unpaid at the due date the interest rate will increase to 15% per annum, with the interest to be paid monthly, which payment will be
$1,250 per month.
NOTE 10 INCOME TAXES
In 2017, the U.S. enacted the Tax Cuts and Jobs Act
which significantly changed U.S. tax law. The Act lowered the U.S. statutory federal income tax rate from 35% to 21% effective January
1, 2018. This had an effect on the value of the Companys net operating loss carryover, but since the deferred tax asset is fully
reserved, it had no impact on the Companys financial statements. The impact of the change was reflected in the 2018 financial statements.
The income tax provision differs from the amount of
income tax determined by applying the U.S. federal and applicable state income tax rates to pretax income from continuing operations for
the years ended December 31, 2024 and 2023, due to the following:
|
|
|
|
2024 |
|
2023 | |
|
|
|
|
|
|
| |
|
Book Income (Loss) |
$ |
(17,462) |
$ |
(32,637) | |
|
Depreciation |
|
- |
|
- | |
|
Shares issued for services |
|
- |
|
- | |
|
Meals and entertainment |
|
- |
|
- | |
|
Amortization of debt discount |
|
- |
|
- | |
|
(Gain) Loss on derivative |
|
- |
|
- | |
|
|
|
|
|
| |
|
Change in valuation allowance |
$ |
17,462 |
$ |
32,637 | |
Net deferred tax liabilities consist of the following
components as of December 31, 2024, and 2023:
40
|
|
|
|
2024 |
|
2023 | |
|
|
|
|
|
|
| |
|
Deferred tax assets: |
|
|
|
| |
|
|
NOL Carryover |
$ |
2,266,924 |
$ |
2,198,579 | |
|
Deferred tax liabilities |
|
|
|
| |
|
|
Depreciation |
|
- |
|
- | |
|
Valuation allowance |
|
(2,266,924) |
|
(2,198,579) | |
|
Net deferred tax asset |
$ |
- |
$ |
- | |
Due to the change in ownership provisions of the
Tax Reform Act of 1986, net operating loss carryforwards for Federal income tax reporting purposes are subject to annual
limitations. If a change in ownership occurs, then net operating loss carryforwards may be limited as to use in future years.
At December 31, 2024, the Company had net operating loss carryforward of approximately $14,616,819 that may be offset against
future taxable income from the year 2025 through 2038. The availability of some of the net operating loss will extend into 2039 if
not previously utilized. During 2024, the Company evaluated its deferred tax assets and concluded that none of the asset is
currently realizable and that a full valuation allowance should be recorded.
Included in the balance at December 31, 2024, are
no tax positions for which the ultimate deductibility is highly certain but for which there is uncertainty about the timing of such deductibility.
Because of the impact of deferred tax accounting, other than interest and penalties, the disallowance of the shorter deductibility period
would not affect the annual effective tax rate but would accelerate the payment of cash to the taxing authority to an earlier period.
NOTE 11 - SUBSEQUENT EVENTS
The Company has evaluated subsequent events pursuant
to ASC Topic 855 and has determined that there are no other events that require disclosure as of the date of issuance.
41