Item 1. Business
ITEM
1 - BUSINESS
Overview
Impact
Biomedical Inc. (“IBO”. “Impact”, “Impact BioMedical”, “we”, “us”, “our”
or the “Company”) discovers, confirms, and patents unique science and technologies which can be developed into new offerings
in human healthcare and wellness in collaboration with external partners through licensing, co-development, joint ventures, and other
relationships, and currently trades on the NYSE American under ticker symbol IBO.
By
leveraging technology and new science with strategic partnerships, we provide advances in biopharmaceuticals, over the counter direct
to consumer wellness offerings, and drug discovery for the prevention, inhibition, and treatment of neurological, oncologic, and inflammatory
diseases. In addition to our existing efforts, we continually search for, and evaluate, other potential new offerings to add to our portfolio.
Our
business model includes partnering and potentially direct sales for commercialization and distribution. Potential licensors and development
partners include pharmaceutical, consumer packaged goods companies and others, who would commercialize IBO technologies in exchange for
milestone, and royalty payments. Currently, our operations are conducted, and our assets are owned through our principal subsidiaries:
(i) Global BioLife, Inc. (“Global BioLife”), which was incorporated on April 14, 2017, (ii) Impact BioLife Science, Inc.
(“Impact BioLife”), which was incorporated on August 28, 2020, (iii) Global BioMedical, Inc. (“Global BioMedical”),
which was incorporated on April 18, 2017, and (iv) Sweet Sense, Inc. (“Sweet Sense”), which was incorporated on April 30,
2018.
In
addition to our existing efforts, we continually search and evaluate other potential new offerings to add to our portfolio.
Below
is a list of our principal subsidiaries:
Impact
BioLife Science, Inc . We are the sole owner of the issued and outstanding common stock of Impact BioLife Science, Inc.
Global
Biomedical, Inc. We own 90.9% of Global Biomedical, Inc. issued and outstanding common stock.
Global
BioLife, Inc . Through our majority owned subsidiary Global Biomedical, Inc., we own 81.8% of the issued and outstanding common
stock of Global BioLife, Inc.
Sweet
Sense, Inc . We own approximately 95.5% of the issued and outstanding common stock of Sweet Sense.
Impact
BioMedical has several unique and proprietary technologies that are in continuing development.
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Linebacker
Linebacker
is a platform of small molecule electrophilically enhanced polyphenol compounds with potential application in oncology (solid tumors),
inflammatory disorders, and neurology. Polyphenols are substances found in many nuts, vegetables, and berries. Linebacker compounds are
modified Myricetin, which is a common plant-derived flavonoid. Myricetin exhibits a wide range of activities that include strong antioxidant
and anti-inflammatory activities (source: NIH).
Linebacker
can potentially be developed as monotherapy or co-therapy to down-regulate PIM (proviral integration site for Moloney murine leukemia
virus) kinase which plays a key role as an oncogene in various cancers (e.g. colon, lung, prostate, breast). Additional potential applications
include inflammatory disorders and neurology.
Linebacker-1
and Linebacker-2 compounds have been licensed to ProPhase Laboratories (NASDAQ: PRPH) for development and commercialization worldwide,
from which Impact Biomedical could receive future milestone and royalty payments.
Composition
and method patents are issued to the Company for Linebacker in the U.S. and other countries.
Laetose
Laetose™
technology demonstrates compelling potential in reducing caloric intake and glycemic index in foods, while also inhibiting tumor necrosis
factor alpha (TNF-α), a cytokine associated with inflammatory chronic diseases (data on file with IBO).
The
patented formulation has potential to inhibit the inflammatory and metabolic response of sugar alone and has potential applications in
therapeutic administration to reduce or limit inflammatory or metabolic diseases (e.g., diabetes). Use of Laetose in a daily diet, compared
to sugar, could result in 30% lower sugar consumption and lower caloric and glycemic index/load.
Laetose
has a unique composition patent allowed in the United States and other countries
worldwide.
IBO
is actively seeking potential partners for further development and commercialization of Laetose as a consumer-packaged or biopharmaceutical
offering worldwide.
Functional
Fragrance Formulation (“3F”)
3F
is a suite of “functional fragrances” containing specialized botanical ingredients (e.g., terpenes) with potential application
as an antimicrobial, or as an additive in insect repellents, detergents, lotions, shampoo, fabrics and other substances to increase effectiveness.
IBO
has partnered with the Chemia Corporation (St. Louis, MO) to pursue development of the 3F technology. Chemia is a leading developer and
manufacturer of fragrances and flavors.
In
addition to Chemia, IBO is actively seeking potential partners for further development and commercialization of 3F worldwide, given the
broad application of this technology.
Composition
patents have been issued in the U.S. and are pending in other countries.
Equivir
Equivir/Equivir
G technology is a novel blend of FDA Generally Recognized as Safe (GRAS) eligible polyphenols (e.g. Myricetin, Hesperetin, Piperine)
which have demonstrated antiviral effects with additional potential application as health supplements or medication. Polyphenols are
substances found in many nuts, vegetables, and berries. Myricetin is a member of the flavonoid class of polyphenolic compounds with antioxidant
properties. Hesperitin is a flavanone and Piperine is an alkaloid, commonly found in black pepper.
Equivir/Equivir
G is licensed to ProPhase Laboratories for development and commercialization worldwide. ProPhase Lab’s initial focus is for use
as an over-the-counter offering for upper respiratory wellness. Additional applications could be pursued in the future.
Method
and composition patents are issued in the U.S. and other countries.
Emerging
Technology
Impact
BioMedical continually evaluates additional proprietary technologies that are in various phases of development. These include, and are
not limited to biopharmaceuticals, indoor air quality products, preservatives, bioplastics, personalized medicine (e.g. genomics, diagnostics),
nanotechnology, cannabis products and technology, pain management, and others.
These
activities include discussions with potential companies/technologies which, subject to completion of diligence, and approval of the respective
management boards, could potentially expand the offerings of Impact Biomedical Inc. There is no assurance that anyone, or all, of these
will result in a material transaction and this is exemplary of consistent and ongoing search and discovery efforts within Impact Biomedical
Inc.
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2025
RECAP
Impact
BioMedical (IBO) continued to develop strong potential through expanding a robust intellectual property(IP) portfolio, partnerships for
development, registration, and commercialization, and positioning the company for near-term revenue generation.. The company’s
technologies address critical health challenges, with significant market potential in both developed and emerging markets.
IBO
is built on a foundation of cutting-edge technologies, strong IP, and partnerships to improve human health and wellness. Progress advanced
considerably in 2025.
Intellectual
Property:
Technology
and patent platforms were expanded in 2025, resulting in sixty (60) issued and over sixty (60) pending patents at the end of 2025. Accomplishments
include:
●
Allowance of our Laetose patent in Europe, representing a novel
combination of one or more sugars and myo-inositol, with the potential to inhibit the inflammatory and metabolic response of sugar alone.
This could be utilized as a diet supplement or biopharmaceutical, and discussions with potential partners to advance commercialization
efforts continue. This expands the worldwide potential following the first U.S. allowance in 2024.
●
Expansion of the 3F patent estate with a U.S. allowance for
infectious disease The technology is designed to act as an antibacterial or antiviral agent, with potential applications for killing
microbes as a disinfectant or as a treatment for infectious diseases (e.g., E. coli, MRSA, influenza, rhinovirus, and M. tuberculosis).
3F also received an allowance in Europe for application as a natural insect repellent. Applications range from standalone repellents
to integrations in shampoos and detergents.
Commercialization/Revenue
Generation:
The
Equivir platform, licensed to ProPhase Labs continued planning for potential commercialization, contingent on meeting targeted marketing
claims, and securing a distribution partner or network.
The
company announced the acquisition of Celios Air Purification technology company, to enhance its ability to combat pathogens. This technology
is a patented, three-stage mechanical filtration system that provides virtual cleanroom-quality air by capturing up to 99.99% of ultrafine
particles down to 10 nanometers in size, significantly exceeding traditional HEPA standards, without producing harmful byproducts like
ozone or other chemical off gassing. This acquisition aligns with Impact Biomedical’s focused roll-up strategy, to expand its portfolio
with cutting-edge solutions with potential for immediate revenue while reinforcing its commitment to human health and wellness.
Financial:
Impact
BioMedical Inc. announced a definitive merger agreement to be acquired by Dr. Ashleys Limited in a reverse merger. This strategic move
combines Dr. Ashleys’ global pharmaceutical manufacturing with Impact BioMedical’s patent portfolio, creating a new, stronger entity
traded on the NYSE American to accelerate revenue generation and continued new product and technology development.
Impact
BioMedical Inc. entered a debt conversion agreement with DSS, Inc. (DSS) to settle approximately $15 million in outstanding principal
and interest debt related to a 2023 promissory note payable to DSS, Inc. by issuing 31,939,778 shares of common stock to DSS. This transaction
strengthens Impact’s balance sheet, increases equity, removes all non-trade debt obligations, and is part of a strategic merger/equity
alignment, that will facilitate the merger of Impact and Dr. Ashleys into a new public entity.
In
summary, 2025 delivered an improved financial position, new and improved technology and patent platforms, and strategic merger plans
to drive anticipated near-term revenue generation.
Reporting
Operating Segments:
The
Company reports its segment information to reflect the manner in which the Company’s chief operating decision maker (“CODM”)
reviews and assesses performance. The Company’s Chief Executive Officer and Chief Operating Officer have joint responsibilities
as the CODM and review and assess the performance of the Company as a whole.
The
primary financial measures used by the CODM to evaluate performance and allocate resources are net income (loss) and operating income
(loss). The CODM uses net income (loss) and operating income (loss) to evaluate the performance of the Company’s ongoing operations
and as part of the Company’s internal planning and forecasting processes. Information on Net income (loss) and Operating income
(loss) is disclosed in the Consolidated Statements of Operations. Segment expenses and other segment items are provided to the CODM on
the same basis as disclosed in the Consolidated Statements of Operations.
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The
CODM does not evaluate performance or allocate resources based on segment assets, and therefore such information is not presented in
the notes to the financial statements.
Impact
BioMedical currently operates as one business segment.
Biotechnology:
(“Biotech”) Impact BioMedical, Inc. targets unmet, urgent medical needs and expands the borders of medical and pharmaceutical
science. Impact drives mission-oriented research, development, and commercialization of solutions for medical advances in human wellness
and healthcare. By leveraging technology and new science with strategic partnerships, Impact BioMedical provides advances in drug discovery
for the prevention, inhibition, and treatment of neurological, oncology and immuno-related diseases. Other exciting technologies include
a breakthrough alternative sugar aimed to combat diabetes and functional fragrance formulations aimed at the industrial and medical industry.
Intellectual
Property
We
strive to protect the intellectual property that we believe is important to our business, including seeking and maintaining patent protection
intended to cover the composition of matter of our product candidates, their methods of use, their methods of production, related technologies
and other inventions. In addition to patent protection, we also rely on trade secrets to protect aspects of our business that are not
amenable to, or that we do not consider appropriate for, patent protection, including certain aspects of technical know-how.
Our
commercial success depends in part upon our ability to obtain and maintain patent and other proprietary protection for commercially important
technologies, inventions and know-how related to our business, defend and enforce our intellectual property rights, particularly our
patent rights, preserve the confidentiality of our trade secrets and operate without infringing valid and enforceable intellectual property
rights of others.
Patent
positions for emerging companies like us are uncertain and can involve complex legal, scientific and factual issues. In
addition, the coverage claimed in a patent application can be significantly reduced before a patent is issued, and its scope can be
reinterpreted and even challenged after issuance. As a result, we cannot guarantee that any of our product candidates will be
protectable or remain protected by enforceable patents. We cannot predict whether the patent applications we are currently pursuing
will be issued as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient
proprietary protection from competitors. Any patents that we hold may be challenged, circumvented or invalidated by third
parties.
We currently have rights or ownership to sixty-nine (69) issued patents and more than sixty (60) pending patents
in countries worldwide. These include composition, method, and design patents.
Trademarks:
We
have several trademarks related to Impact BioMedical.
Websites:
The
primary corporate website we maintain is www.impactbiomedinc.com .
Markets
and Competition
Impact
Biomedical is focused on the discovery, development, and commercialization of products and technologies to address unmet needs in human
healthcare and wellness. Specific areas of focus include specialty biopharmaceuticals, antivirals, antimicrobials, and consumer healthcare
and wellness products, often derived from naturally sourced elements. These efforts compete with many different sources, including major
pharmaceutical, specialty pharmaceutical, and biotechnology companies, academic institutions and governmental agencies, and public and
private research institutions.
Customers
The
business model of Impact BioMedical includes licensing and potentially direct sales for commercialization and distribution. Potential
licensors and development partners include pharmaceutical, food, consumer package goods companies and others in exchange for milestone,
and royalty licensing payments.
Raw
Materials
None.
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Environmental
Compliance
It
is the Company’s policy to conduct its operations in accordance with all applicable laws, regulations, and other requirements.
While it is not possible to quantify with certainty the potential impact of actions regarding environmental matters, particularly remediation
and other compliance efforts that the Company may undertake in the future, in the opinion of management, compliance with the present
environmental protection laws, before taking into account estimated recoveries from third parties, will not have a material adverse effect
on the Company’s consolidated annual results of operations, financial position or cash flows.
Government
Regulation
We
are faced with potential government regulations. If new legislation, regulations, or rules are implemented either by Congress, the U.S.
Patent and Trademark Office (the “USPTO”), or the courts that impact the patent application process, the patent enforcement
process or the rights of patent holders, these changes could negatively affect our patent monetization efforts and, in turn, our assets,
expenses and revenue. United States patent laws have been amended by the Leahy-Smith America Invents Act. The America Invents Act includes
several significant changes to U.S. patent law. In general, the legislation attempts to address issues surrounding the enforceability
of patents and the increase in patent litigation by, among other things, establishing new procedures for patent litigation. For example,
the America Invents Act changes the way that parties may be joined in patent infringement actions, increasing the likelihood that such
actions will need to be brought against individual parties allegedly infringing by their respective individual actions or activities.
In addition, the U.S. Department of Justice (“DOJ”) has conducted reviews of the patent system to evaluate the impact of
patent assertion entities, such as our Company, on industries in which those patents relate. It is possible that the findings and recommendations
of the DOJ could adversely impact our ability to effectively license and enforce standards-essential patents and could increase the uncertainties
and costs surrounding the enforcement of any such patented technologies.
Moreover,
new rules regarding the burden of proof in patent enforcement actions could significantly increase the cost of our enforcement actions,
and new standards or limitations on liability for patent infringement could negatively impact our revenue derived from such enforcement
actions.
Corporate
History
Impact
BioMedical, Inc., incorporated in the State of Nevada on October 16, 2018, through the utilization of its intellectual property rights,
or through investment in, or through acquisition of companies in the biohealth and biomedical fields, focuses on the advancement of drug
discovery and prevention, inhibition, and treatment of neurological, oncological, and immune related diseases. The Company is also developing
open-air defense initiatives, which curb transmission of air-borne infectious diseases, such as tuberculosis and influenza. See the “Overview”
section above for further details about our Company.
Employees
The
Company currently has two full-time employee and six shared employees with DSS as of December 31, 2025.
Available
information
Our
website address is www.impactbiomedinc.com . Information on our website is not incorporated herein by reference. We make available
free of charge through our website our press releases, Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K and all amendments to those reports as soon as reasonably practicable after electronically filed with or furnished to the Securities
and Exchange Commission.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.