What changed in this filing

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Item 1. Business

2025-03-28 compared with 2024-02-20 · 152 added, 183 removed, 156 unchanged (68% of the section changed)

Biomedical Inc.

“Impact”, “Impact BioMedical”, “we”, “us”,

“our” or the “Company”) is a subsidiary of DSS, Inc (“DSS”:

IBIO 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.

Our activities

range from the discovery of technologies and leveraging those technologies to create and commercialize product candidates.

Currently, our operations are conducted, and our assets are owned primarily through our principal subsidiaries:

(i) Global BioLife,

(“Global BioLife”), which was incorporated on April 14, 2017, (ii) Impact BioLife Science (“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,

discover, confirm, and patent 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.

By leveraging technology

and new science with strategic partnerships, we provide advances in drug discovery for the prevention, inhibition, and treatment of neurological,

oncology and immuno-related diseases.

Other exciting technologies include natural compositions for over-the-counter upper respiratory,

anti-viral and other conditions, functional fragrance formulations for use in lotions, insect repellents, and other consumer products

and a unique alternative sugar composition, with potential to impact calorie intake and glycemic index.

business model 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.

“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.

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

In addition to our existing efforts, we continually search for, and evaluate, other potential new offerings to add to our portfolio.

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,

(“Global BioMedical”), which was incorporated on April 18, 2017, and (iv) Sweet Sense, Inc.

Sense”), which was incorporated on April 30, 2018.

leveraging technology and new science with strategic partnerships, we provide advances in biopharmaceuticals and over the counter direct

to consumer wellness offerings, and drug discovery for the prevention, inhibition, and treatment of neurological, oncology and immuno-related

addition to our existing efforts, we continually search and evaluate other potential new offerings to add to our portfolio.

is a list of our principal subsidiaries:

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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.

Through our majority owned subsidiary Global Biomedical, Inc., we own 81.8% of the issued and outstanding common

stock of Global BioLife, Inc.

We are the owner of 95.5% of the issued and outstanding common stock of Sweet Sense.

our majority-owned subsidiary Global BioLife, we own or have rights to a portfolio of biomedical intellectual property, including intellectual

property assigned to Global BioLife by GRDG Sciences, LLC (“GRDG”).

Global BioLife leverages its scientific know-how and

intellectual property rights to develop various emerging technologies, including biopharmaceuticals, antivirals, antimicrobials, sugar

alternatives, insect repellents, fragrances, bioplastics and natural preservatives.

BioMedical has several unique and proprietary technologies that are in continuing development.

is a platform of small molecule electrophilically enhanced polyphenol compounds with potential application in oncology (solid

tumors), inflammatory disorders, and neurology.

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.

compounds are modified Myricetin, which is a common plant-derived flavonoid.

Myricetin exhibits a wide rand of activities that

include strong anti-oxidant, as well as potential anti-cancer, anti-inflammatory activities (source:

Linebacker can

potentially be developed as monotherapy or co-therapy to down-regulate PIM (proviral integration site for Moloney murine leukemia

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:

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.

Lineebacker-1 and Linebacker-2 compounds have been licensed to ProPhase

(“ProPhase”) (NASDAQ:

Additional potential applications

include inflammatory disorders and neurology.

and Linebacker-2 compounds have been licensed to ProPhase Laboratories (NASDAQ:

PRPH) for development and commercialization worldwide,

Composition and method patents

are issued for Linebacker in the U.S.

from which Impact Biomedical could receive future milestone and royalty payments.

and method patents are issued to the Company for Linebacker in the U.S.

and other countries.

compounds from the Linebacker platform (LB-1, LB-2) are licensed to ProPhase for clinical development and

commercialization for which Impact BioMedical could receive future milestone payments and royalties.

technology is derived from a unique combination of sugar and inositol, which has the potential ability to inhibit the inflammatory and

metabolic response of sugar alone.

Use of Laetose in a daily diet, compared to sugar, could result in 30% lower sugar consumption and

lower caloric and glycemic index/load.

Patents/Intellectual

Property Summary Laetose U.S.

composition and method patent is filed, published, and awaiting issue.

are actively seeking potential partners for further development and commercialization of Laetose as a consumer packaged offering worldwide.

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).

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.

has a unique composition patent allowed in the United States and patents are pending in other countries worldwide.

is actively seeking potential partners for further development and commercialization of Laetose as a consumer-packaged or biopharmaceutical

offering worldwide.

Fragrance Formulation (“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.

patents have issued in the U.S.

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.

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.

addition to Chemia, IBO is actively seeking potential partners for further development and commercialization of 3F worldwide, given

the broad application of this technology.

patents have been issued in the U.S.

and are pending in other countries.

are actively seeking potential partners for further development and commercialization of 3F.

Equivir/Equivir

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Polyphenols are

sourced from fruits, vegetables, and other natural substances.

Myricetin is a member of the flavonoid class of polyphenolic compounds

with antioxidant properties.

substances found in many nuts, vegetables, and berries.

Myricetin is a member of the flavonoid class of polyphenolic compounds with antioxidant

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.

and composition patents are issued in the U.S.

and other countries.

Equivir/Equivir

G is licensed to ProPhase for development and commercialization worldwide.

continues to explore and discover potential new technologies in accordance with its business model.

Areas of interest include bioplastics,

preservatives, biopharmaceuticals and other categories which could result in differentiated and proprietary offerings in human healthcare.

July 31, 2023, DSS, Inc.

announced today the distribution date for the previously announced stock dividend of Impact BioMedical Inc.

shareholders of record on July 10, 2023 will be entitled to four (4) shares of Impact Biomedical Inc.

for every one (1) share

of DSS to be distributed on August 8, 2023.

Approximately 8,821,000 shares were issued as part of this distribution.

October 23, 2023, DSS announced that IBIO, its majority-owned subsidiary, had filed a Registration Statement on Form S-1 with the U.S.

Securities and Exchange Commission (“SEC”) relating to its proposed initial public offering

November 6, 2023, IBIO filed a Current Report on Form 8-K disclosing a reverse split of its issued and outstanding common stock by

a ratio of 1 for 55 and a conversion of certain holder’s common stock into preferred stock.

Impact did not effectuate a reverse

split of its authorized capital stock and no amendment to the articles of incorporation or bylaws was made.

Impact received approval from

its majority stockholder and the Company’s Board of Directors (the “Board”) to effectuate the reverse split.

following is a summary of the DSS reported transactions and investments since January 2022 that reflect the active advancements and investments

in these business lines:

January 11, 2022, Impact Biomedical, Inc., a wholly owned subsidiary of DSS, Inc, along with its scientific research partner Global

Research and Discovery Group Sciences, (GRDG) announced a project that is designed to take plastics in a whole new direction with

the development of what we call Bio-plastics.

Bio-plastics under development are designed to make everyday objects resistant to viruses,

and also gentler to the planet.

March 03, 2022, Impact Biomedical, Inc., a wholly owned subsidiary of DSS, Inc, along with its scientific research partner Global

Research and Discovery Group Sciences, (“GRDG”) announced it had received a positive report regarding the potential international

patentability of its proprietary compound Equivir to treat viral infections which has shown potential to limit the occurrence of, and

reduce, the risk or severity of viral outbreaks.

June 07, 2022, DSS announced that Global BioLife, Inc, a division of the Company’s wholly owned subsidiary Impact BioMedical,

was granted a patent from the China National Intellectual Property Administration (“CNIPA”) for 3F™, a Functional Fragrance

Formulation technology that is effective as a mosquito repellant through a fragrant compound derived from botanical oils.

This complements

the corresponding U.S.

patent granted (U.S.

3F™ is an extremely effective mosquito repellant.

The repellant is believed

to incapacitate two of the three receptors that mosquitoes use to find sources of nutrition.

During the past year, Impact BioMedical

has laid the groundwork for a future that is focused on scientifically tested, high-impact solutions to global problems that humans are

facing from food preservation to antibiotics to creating new ways to develop medicines.

Impact Biomedical and GRDG announced a U.S.

(US 10,966,424) allowance for 3F™DB in June 2021.

June 28, 2022, Impact Biomedical, Inc, along with its scientific research partner GRDG, announced that it signed a license agreement

with ProPhase Labs, Inc.

PRPH) for Equivir, which has shown potential as a treatment to limit the occurrence of or reduce the

risk or severity of viral outbreaks.

Since 2019 Equivir as a treatment against viral infections has received two U.S.

patents and a positive

patentability report opening the door for international patent possibilities.

The composition is believed to work by potentially blocking

the entry of a virus into host cells, which prevents infection and replication in those host cells.

Equivir is a blend of FDA Generally

Recognized as Safe (GRAS) eligible polyphenols.

The composition is projected to come in capsule form and be taken much like a multivitamin.

July 21, 2022, DSS Inc, announced that Global BioLife, Inc, a subsidiary of the Company’s wholly owned subsidiary Impact BioMedical,

Inc, executed a license agreement with ProPhase BioPharma, Inc, a subsidiary of ProPhase Labs, Inc, a rapidly growing and diversified

diagnostics, genomics and biotech company, for Global BioLife’s Linebacker portfolio (LB-1 and LB-2), two patented small molecule

PIM kinase inhibitors with significant potential across multiple therapeutic indications.

LineBacker is anticipated to be effective in

crossing the blood-brain barrier and would be delivered orally.

Significant pre-clinical testing has been completed in neurology, anti-inflammatory,

oncology, anti-infective, and viral disease states to demonstrate response to LineBacker.

October 19, 2022, GRDG, a scientific research partner of Impact BioMedical, Inc., a wholly owned subsidiary of DSS, Inc, announced

that it will be the subject of a documentary film highlighting the passion, the search, and the cutting-edge discoveries that push the

company behind a single-minded goal:

creating a healthier world quickly and naturally.

The documentary project comes on the heels of

GRDG’s completion of Sombrero, a five-year multi-pronged project that yielded multiple patents and potentially billions of dollars

in licensing opportunities.

Impact Biomedical discovers, confirms, and patents unique science and technologies resulting in new offerings in

human healthcare and wellness.

Once available IBIO works closely with licensing, co-development, joint ventures, and other relationships

to bring these offerings to market.

These efforts, subject to successful completion of clinical and scientific studies to substantiate

claims and regulatory body approvals, could lead to continued new patent allowances, commercialization worldwide, and growth in revenue

and income going forward.

Two of our technologies, Equivir and LineBacker, have been licenses to ProPhase Labs, Inc.

Under the terms of that agreement, ProPhase will be developing the LineBacker platform, and preclinical studies are ongoing with preliminary

results expected during the first quarter of 2024.

Prophase is also conducting studies with Equivir, with results expected in the first/second

quarter of 2024.

With successful results, launch of an over-the-counter offering is projected in the second half of 2024.

We also anticipate

to generate significant revenue growth through securing new milestone and royalty licensing revenue with Laetose and Functional Fragrance

Formulation (“3F”) going forward.

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.

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

a relatively new public entity, Impact BioMedical (IBO) has already demonstrated an ability to establish an experienced leadership

team, attract investor confidence, build a robust intellectual property(IP) portfolio, and create partnerships for development,

registration, and commercialization.

The company’s technologies address critical health challenges, with significant market

potential in both developed and emerging markets.

is built on a foundation of cutting-edge technologies, strong IP, and partnerships to improve human health and wellness.

Progress advanced

considerably in 2024:

new patent platforms were established in 2024 adding to the 36 issued and 50+ patents in the IBO portfolio.

Accomplishments in 2024 include:

The first U.S.

Laetose patent 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.

be utilized as a diet supplement or biopharmaceutical, and discussions with potential partners to advance commercialization efforts continue.

Expansion of the U.S.

3F patent estate with new compositions

and formulations of constituents found in plants and fragrances with application as a natural insect repellent.

Applications range from

standalone repellents to integrations in shampoos and detergents.

Regional expansion of the Linebacker patent estate with granting

of a Canadian patent for unique phenolic compounds and pharmaceutical compositions in treating inflammatory related diseases.

This platform

offers potential relief for conditions such as arthritis, asthma, and inflammatory bowel disease, while mitigating the side effects associated

with traditional treatments.

Commercialization/Revenue

Equivir platform, licensed to ProPhase Labs completed the first human study with potential application as a diet supplement in treating

upper respiratory infections.

Final study results are anticipated in mid-2025, and contingent on meeting targeted marketing claims, Equivir

will launch in the U.S.

for the 2025-2026 cold and flu season.

of our Initial Public Offering(IPO) in September 2024, provided us with resources to accelerate our research and development initiatives,

expand our market presence, and enhance shareholder value.

successfully restructured our long-term debt during the third quarter of 2024, which improves our financial flexibility, enabling repayment

of debt with company equity for 24 months, enabling cash preservation.

summary, 2024 delivered an improved financial position, platform and regional expansion of IP estate, completion of the first human study

with IBO technology (Equivir) with potential for near-term revenue generation, and a dedicated leadership team.

Operating Segments:

Impact BioMedical currently operates as one business segment.

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.

primary financial measures used by the CODM to evaluate performance and allocate resources are net income (loss) and operating income

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.

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

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.

Impact BioMedical has several important and valuable products, technology or compounds that are in continuing development and/or

licensing stages:

targets unmet, urgent medical needs and expands the borders of medical and pharmaceutical

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.

BioMedical has several important and valuable products, technology or compounds that are in continuing development and/or licensing stages:

Multi-faceted therapeutic platform for metabolic, neurologic, cancer, and infectious diseases.

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and cognitive processes to toxin neutralization and immunity against pathogens.

The business model of Impact BioMedical revolves around two methodologies – Licensing and Sales Distribution.

business model of Impact BioMedical revolves around two methodologies – Licensing and Sales Distribution.

Impact develops valuable and unique patented technologies which will be licensed to pharmaceutical, large consumer package goods

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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

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.

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and Competition

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.

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.

business model of Impact BioMedical includes licensing and potentially direct sales for commercialization and distribution.

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on the Company’s consolidated annual results of operations, financial position or cash flows.

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.

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.

America Invents Act includes several significant changes to U.S.

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.

The America Invents Act includes

several significant changes to U.S.

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.

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.

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open-air defense initiatives, which curb transmission of air-borne infectious diseases, such as tuberculosis and influenza.

the “Overview” section above for further details about our Company.

Company currently has one full-time employee and four shared employees with DSS as of December 31, 2023.

See the “Overview”

section above for further details about our Company.

Company currently has two full-time employee and six shared employees with DSS as of December 31, 2024.

website address is www.impactbiomedinc.com .

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business