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Item 1. Business

2026-04-15 compared with 2025-04-11 · 202 added, 1254 removed, 25 unchanged (98% of the section changed)

is a clinical stage pharmaceutical company committed to extending healthy lifespan.

TNF is focused on developing and commercializing

two therapeutic platforms based on well-defined therapeutic targets, Isomyosamine and Supera-CBD:

Isomyosamine is a clinical stage small

molecule that regulates the immunometabolic system to treat autoimmune disease, including (but not limited to) sarcopenia, frailty, adverse

effects of drugs used to treat diabetes and obesity, rheumatoid arthritis, and inflammatory bowel disease.

The first indication for which

Isomyosamine is being developed is to treat age-related frailty and sarcopenia.

Isomyosamine works by regulating the release of numerous

pro-inflammatory cytokines, such as TNF-α, interleukin 6 (“IL-6”) and interleukin 17 (“IL-17”) .

is a synthetic analog of CBD being developed to treat various conditions, including, but not limited to, epilepsy, pain and anxiety/depression,

through its effects on the CB2 receptor, opioid receptors and monoamine oxidase enzyme (“MAO”) type B.

rights to Supera-CBD TM were previously owned by Supera Pharmaceuticals, Inc.

(“Supera”) and were acquired by MyMD

Florida (as defined below) immediately prior to the closing of the Merger (as defined below) that occurred in 2021.

Technologies, Inc.

(the “Company”) has historically been engaged in the development and commercialization of therapeutic

platforms based on well-defined biological targets, including Isomyosamine and Supera-CBD.

More recently, the Company has shifted

its business strategy to focus on energy-efficient blockchain and cryptocurrency infrastructure through quantum-class laser-based

Company’s core strategy is centered on leveraging an exclusive global licensing agreement with LightSolver Ltd.

(“LightSolver”)

to deploy innovative laser processing units (“LPUs”), including the Company-branded qc-LPU100™ (the “qc-LPU100”).

These systems are designed to harness the natural properties of light to perform complex computations with the goal of achieving high

computational speed and improved energy efficiency relative to traditional computing architectures.

qc-LPU100 is intended to address complex combinatorial and physical problems, including partial differential equations, and is targeted

for applications in cryptocurrency infrastructure, decentralized physical infrastructure networks (“DePin Tokens”), and artificial

intelligence (“AI”)-driven high-performance computing environments that rely on decentralized or distributed systems.

Company seeks to position itself as an early participant in integrating laser-based computing with blockchain infrastructure, addressing

industry challenges such as high energy consumption, scalability limitations, and dependence on traditional graphics processing units

LPUs are designed to operate at room temperature in standard rack-unit configurations and are intended to offer

performance and efficiency advantages compared to GPUs and quantum processing units (“QPUs”), while also enhancing aspects

of blockchain security.

Company is evaluating the potential divestiture of Isomyosamine and Supera-CBD to fund its new strategic focus, with the objective of

creating long-term stockholder value.

Background and Corporate History

was organized under the laws of the State of Florida in November 2014 for the purpose of developing and commercializing certain

technology and patent rights relating to Isomyosamine that were developed and/or held by the company’s founder, Jonnie R.

Williams, Sr.

The Company’s sole initial stockholder was The Starwood Trust, a trust for which Mr.

Williams is the

settlor/grantor.

During the period from November 2014 through November 2016, TNF was primarily focused on drug discovery and

establishing its patent position through SRQ Patent Holdings, an entity affiliated with Mr.

In November 2016, SRQ Patent

Holdings assigned to the Company all the patent rights and other intellectual property relating to Isomyosamine pursuant to an

agreement under which the Company granted to SRQ Patent Holdings a royalty based on product sales and other revenue arising from the

assigned intellectual property (as further described below).

the period 2016 through October of 2020, the Company’s principal business activities consisted of the execution and completion

of in vitro assays, in vivo pre-clinical animal studies, and genotoxicity and toxicology studies relating to Isomyosamine (as

further described below).

On June 25, 2019, the Company commenced a Phase 1 trial in healthy volunteers for pharmacokinetics and tolerability

studies, and in December of 2019, the Company filed an IND for Isomyosamine for treatment of Hashimoto thyroiditis.

The Phase 1 trial was completed

on January 30, 2020, after which the Company commenced preparation of a Phase 2 clinical trial for Isomyosamine.

The Company has also commenced

a Phase 2 clinical trial for patients with sarcopenia, with dosing that began in the first quarter of 2022.

The last patient visit took

place on June 6, 2023.

Additionally, the Company together with h Charles River Laboratories has conducted a study titled “A 13 Week

Electroencephalogram Safety Study of MYMD-1 by Oral Gavage Administration in Beagle Dog.” Analysis and reporting were completed

in December 2024 and the results have been favorably received by the FDA.

Merger and Corporate Transactions

Company was organized under the laws of the State of Florida in November 2014.

April 16, 2021, pursuant to an Agreement and Plan of Merger and Reorganization, dated November 11, 2020 (as subsequently amended, the

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after the merger as the surviving entity and a wholly owned subsidiary of the Company (the “Merger”).

The Merger consideration

included potential milestone payments to the pre-Merger MyMD Florida stockholders (the “Milestone Payments”) payable in shares

of the Company’s Common Stock upon the achievement of certain market capitalization milestone events during the 36-month period

immediately following the closing of the Merger (the “Milestone Period”).

On April 16, 2024, the Milestone Period expired and accordingly, the pre-Merger

MyMD Florida stockholders are no longer entitled to any potential Milestone Payments pursuant to the Merger Agreement.

November 11, 2020, in connection with entering into the Merger Agreement, MyMD Florida entered into an Asset Purchase Agreement with

Supera, pursuant to which, MyMD Florida agreed to acquire from Supera substantially all of the assets (including all rights to

Supera-CBD) and certain obligations of Supera in consideration of the issuance of an aggregate of 13,096,640 shares of MyMD Florida

Common Stock to Supera.

As partial consideration for such an assignment, Supera granted to SRQ Patent Holdings II, LLC a royalty

with respect to product sales and other consideration arising from the assigned intellectual property.

Company previously owned, through its subsidiary Cystron Biotech, LLC (“Cystron”), an exclusive license from Premas

Company previously owned, through its former subsidiary Cystron Biotech, LLC (“Cystron”), an exclusive license from Premas

Biotech PVT Ltd.

(“Premas”) with respect to Premas’ vaccine platform for the development of a vaccine against

COVID-19 and other coronavirus infections.

On April 16, 2021, pursuant to a Contribution and Assignment Agreement, dated March 18,

2021 (the “Contribution Agreement”) by and among the Company, Cystron, Oravax Medical, Inc.

(“Oravax”) and,

for the limited purpose set forth therein, Premas, the Company caused Cystron to contribute substantially all of the assets

associated with its business of developing and manufacturing Cystron’s COVID-19 vaccine candidate to Oravax (the “Contribution Transaction”).

pursuing the development of the COVID-19 vaccine candidate.

The Company’s interest in Oravax consists of 13% of Oravax’s

outstanding shares of capital stock and the rights to a 2.5% royalty on all future net sales.

The Company has evaluated several

options with respect to its interest in Oravax, including a potential distribution of Oravax shares to the Company’s

stockholders.

This would make Oravax a publicly held company.

In addition, TNF currently has the right to designate a member of the

board of directors of Oravax, pursuant to which Mr.

Joshua Silverman, our Chairman of the Board, has been designated to serve as a

director of Oravax.

(“Premas”) with respect to Premas’ vaccine platform for the development of a vaccine against COVID-19

and other coronavirus infections.

On April 16, 2021, pursuant to a Contribution and Assignment Agreement, dated March 18, 2021 (the “Contribution

Agreement”) by and among the Company, Cystron, Oravax Medical, Inc.

(“Oravax”) and, for the limited purpose set forth

therein, Premas, the Company caused Cystron to contribute substantially all of the assets associated with its business of developing

and manufacturing Cystron’s COVID-19 vaccine candidate to Oravax (the “Contribution Transaction”).

The Company’s

interest in Oravax consists of 13% of Oravax’s outstanding shares of capital stock and the rights to a 2.5% royalty on all future

The Company has evaluated several options with respect to its interest in Oravax, including a potential distribution of Oravax

shares to the Company’s stockholders.

Reincorporation and Name Change

July 22, 2024, the Company changed its name from MyMD Pharmaceuticals, Inc.

to TNF Pharmaceuticals, Inc.

by filing a certificate of amendment

to its certificate of incorporation with the Secretary of State of Delaware.

In addition, effective before the open of market trading

on July 24, 2024, the Company’s common stock, par value $0.001 per share (“Common Stock”) ceased trading under the

ticker symbol “MYMD” and began trading on the Nasdaq Stock Market under the ticker symbol “TNFA.”

the Company’s annual meeting of stockholders held on July 31, 2023, the stockholders approved a plan to merge the Company with

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to Delaware, the par value of the Company’s Common Stock and preferred stock was changed to $0.001 per share.

Delaware is deemed to be the successor issuer of MyMD New Jersey under Rule 12g-3 of the Securities Exchange Act of 1934, as amended.

Reincorporation did not result in any change in the Company’s name, business, management, fiscal year, accounting, location of

the principal executive offices, assets or liabilities.

Holders of shares of the Company’s Common

Stock did not have to exchange their existing MyMD New Jersey stock certificates for MyMD Delaware stock certificates.

of the Effective Date of the Reincorporation, the rights of the Company’s stockholders are governed by the Delaware General Corporation

Law, the MyMD Delaware Certificate of Incorporation and the Bylaws of MyMD Delaware.

TNF is developing two platform drugs targeting numerous disease indications.

Below is TNF’s development pipeline:

strategy is to focus on extending healthy life span through the development and commercialization of novel drug platforms based on well-defined

therapeutic targets.

Below are TNF’s key clinical strategies:

a 28-day Phase 2 clinical trial in sarcopenia (i.e., age-related muscle loss) in the second quarter of 2023, which showed safety and tolerability of Isomyosamine at clinically effective

Initiated a 90-day Phase 2 clinical trial in sarcopenia to evaluate improvement

in clinical outcomes in older sarcopenic patients who have sustained a hip or femur fracture;

Advance Isomyosamine into Phase 2 clinical trials for rheumatoid arthritis

and deleterious effects of drugs (GLP-1 agonists) used in patients with Type II diabetes to assist in weight loss;

on IND-enabling studies of Supera-CBD to enable submission of an IND for a Phase 1 clinical trial in healthy volunteers followed

by Phase 2 clinical trials in epilepsy, addiction and anxiety disorders;

and validate additional novel targets and utilize translational platforms to develop a pipeline of product candidates for aging and

other autoimmune disease;

broad commercial rights to TNF’s product candidates;

to strengthen and expand TNF’s intellectual property portfolio.

Isomyosamine is a clinical stage

drug that targets the immune system by inhibiting the release of pro-inflammatory cytokines, such as TNF-α.

Cytokines are a broad

category of molecules involved in immune system coordination(“Immunometabolic regulation”).

By affecting the initial triggers

that drive autoimmunity, Isomyosamine targets the underlying cause of these diseases rather than just their symptoms.

TNF has completed

a 28-day Phase 2 clinical trial for sarcopenia (age-related muscle loss) that showed safety and tolerability at clinically meaningful

doses, without dose-limiting side effects or immunosuppression.

TNF has initiated a Phase 2b clinical trial to evaluate clinical outcome

improvements in sarcopenic patients who have sustained a hip or femur fracture.

TNF has an active IND with the Endocrinology Division

at the FDA for other autoimmune diseases.

Studies have been completed on the mechanisms of action and efficacy of Isomyosamine in several

pre-clinical models of autoimmune diseases (i.e., experimental autoimmune encephalomyelitis (“EAE”) that models multiple sclerosis

and autoimmune thyroiditis), and these studies have been published in peer reviewed journals.

TNF plans to pursue these indications.

July 22, 2024, the Company changed its name from MyMD Pharmaceuticals, Inc.

to TNF Pharmaceuticals, Inc.

by filing a certificate of amendment

to its certificate of incorporation with the Secretary of State of Delaware.

In addition, effective before the open of market trading

on July 24, 2024, the Company’s common stock, par value $0.001 per share (“Common Stock”) ceased trading under the

ticker symbol “MYMD” and began trading on the Nasdaq Stock Market under the ticker symbol “TNFA.”

22, 2025, the Company filed a certificate of amendment to its certificate of incorporation to change the name of the Company from “TNF

Pharmaceuticals, Inc.” to “Q/C Technologies, Inc.” effective as of September 22, 2025.

In addition, effective before

the open of market trading on September 25, 2025, the Company’s Common Stock ceased trading under the ticker symbol “TNFA”

and began trading on the Nasdaq Stock Market under the ticker symbol “QCLS”.

Membership Interest Purchase Agreement

On September 2, 2025, the Company entered into a Membership Interest Purchase Agreement (the “MIPA”)

with LPU Holdings LLC (“LPU”) and the members of LPU (the “Sellers”), pursuant to which the Company acquired

100% of the membership interests of LPU (the “Membership Interests”).

As a result of this transaction, LPU became a wholly

owned subsidiary of the Company and constitutes a reportable segment.

The acquisition of LPU was a foundational step in advancing the

Company’s laser-based computing business.

Laser-Based Computing Business

The Company’s laser-based computing business

represents the Company’s primary strategic focus and is centered on the development, deployment, and commercialization of LPU-based

computing systems.

These systems are designed to utilize photonic processing techniques to address computationally intensive problems

more efficiently than traditional electronic systems.

The Company’s relationship with LightSolver

provides access to licensed technology that emphasizes the development of LPUs, including the qc-LPU100.

The Company is engaged in adapting,

developing and integrating this technology into commercially viable systems targeted at blockchain infrastructure, AI workloads, and high-performance

computing applications.

The qc-LPU100 is intended to solve optimization problems

and physical simulations that are computationally expensive for classical architectures.

The Company believes that its approach may offer

advantages in processing speed, energy consumption and scalability.

In particular, the Company is targeting use cases involving decentralized

compute networks, including DePin Token ecosystems, where efficient computation is critical to network performance and economic viability.

The Company is currently focused on prototype development,

internal validation, and early-stage benchmarking of the qc-LPU100.

These efforts include testing performance characteristics, evaluating

integration with existing computing environments, and refining system design for scalability and manufacturability.

The Company has not yet generated significant revenue

from its laser-based computing business and expects that commercialization will depend on successful prototype validation, customer adoption,

and the Company’s ability to secure additional capital.

September 2025, the Company has undertaken a series of initiatives to implement its strategic transition toward its laser-based computing

In 2025 and 2026, these actions included completing a private placement financing, rebranding its corporate identity, appointing

a senior quantum advisor, and initiating development of the qc-LPU100.

Company’s near-term strategy focuses on completing prototype development, conducting performance benchmarking for targeted applications

such as DePin Tokens and AI workloads, and expanding its intellectual property position, including through the LightSolver licensing

The Company also intends to engage with potential partners and early adopters to conduct pilot testing and proof-of-concept

the intermediate term, the Company anticipates pursuing beta deployments, obtaining necessary hardware certifications, and initiating

initial commercial sales or leasing arrangements.

The Company may also seek additional financing through equity or debt offerings to

support these activities.

Company’s longer-term strategy includes scaling deployment of LPU systems, expanding into additional markets, and establishing

recurring revenue streams through hardware, software, and services offerings.

There can be no assurance that the Company will successfully

execute its strategy or achieve its anticipated milestones.

The Company intends to generate revenue from its laser-based computing business through a combination of hardware sales, leasing

arrangements and service-based offerings.

The Company expects to offer qc-LPU100 systems directly to customers, as well as provide

access to LPU-based computing capacity through subscription or usage-based models.

addition, the Company may pursue licensing or royalty arrangements associated with the integration of its technology into blockchain

infrastructure or other computing platforms.

The Company believes that the potential energy efficiency and performance benefits of

LPUs may create economic incentives for adoption among customers operating in energy-intensive computing environments.

timing and magnitude of revenue generation will depend on a number of factors, including successful product development, customer acceptance,

competitive dynamics, and the availability of capital to support commercialization efforts.

While the Company continues to evaluate potential revenue opportunities, the Company does not currently anticipate

generating revenues in the near term.

Pharmaceutical

Company’s legacy pharmaceutical business remains a reportable segment and consists of the Company’s therapeutic development

programs, which includes Isomyosamine and Supera-CBD:

● Isomyosamine

inhibitor without immunosuppressive liability

Inflammation, activated through

the release of TNF-α and other cytokines, is the body’s normal physiological defense against infections and pathogens, and

under normal circumstances such inflammation quickly resolves once the intruder is neutralized.

However, elevated levels of pro-inflammatory

cytokines, including TNF-α, can lead to prolonged, chronic inflammation, which is closely linked to autoimmune diseases (such as

multiple sclerosis, diabetes, rheumatoid arthritis) and aging (i.e., inflamm-aging) as well as cardiovascular disease and cancers, all

of which may result in reduced health span (the period of life spent in good health).

The goal of Isomyosamine is to

target immune cells that overproduce pro-inflammatory cytokines, such as TNF-α, without preventing normal immune cell function.

TNF-α is a cytokine that is released by immune cells that plays a key role in acute and chronic inflammation, autoimmune diseases

Isomyosamine is a novel small

molecule orally available “immunometabolic” regulator that has demonstrated in vitro and in vivo activity to

regulate the release of multiple cytokines from immune cells, including TNF-α.

Isomyosamine is being developed to treat chronic

inflammatory diseases, with the initial priority of complications of sarcopenia and frailty, which together affect more than 1,000,000

patients in the US.

Regulates Multiple Cytokines

conducted an in vitro study to demonstrate that Isomyosamine regulates a broad range of cytokines, including TNF-α, interferon gamma

(INFγ) and interleukins, including interleukin 2 (“IL-2”) and IL-17A.

By blocking these cytokines that have been shown

to play key roles in the development and maintenance of autoimmune diseases, Isomyosamine treats the causes—and not just the symptoms—of

this class of illnesses.

Isomyosamine modulates the release of a broad spectrum of cytokines.

additional in vitro study demonstrates that Isomyosamine has broad cytokine inhibiting activity including inhibition of TNF-α,

IL-16 and IL-17a.

The study also suggested Isomyosamine has limited toxicity, even at high doses, and none up to 2,000 micromoles.

an in vivo study (NOD.H2 mouse model), Isomyosamine decreased serum levels of TNF-α and INFγ.

Isomyosamine decreases the serum levels TNF-α and IFN-g in NOD.H-2h4 mice.

NOD.H-2h4 mice were treated with either regular water or

iodinated water (500 mg/l of sodium iodide), and each group was treated or not treated with Isomyosamine (185 mg/l).

Cytokines were measured

at baseline and after 6 and 12 weeks of treatment using a multiplex magnetic bead array.

(A and B) Isomyosamine significantly decreased serum

TNF-α levels in the regular water group and tended to decrease it in the iodinated water group.

(C and D) Isomyosamine showed a modest

effect on serum IFN-g in the iodinated water group.

The results are from three independent experiments.

Statistical comparisons were made

by longitudinal data analysis with generalized estimating equations.

Targets Autoimmune Diseases

is designed to regulate the immunometabolic system and intended for development as a potential treatment for certain autoimmune diseases,

including (but not limited to) multiple sclerosis, diabetes, rheumatoid arthritis, and/or inflammatory bowel disease.

Isomyosamine is also

being developed to treat age-related illnesses such as frailty and sarcopenia.

Autoimmune diseases are a broad category of diseases that

result from an overactive immune response, where immunometabolic system dysregulation is believed to play an important role.

immune system defends the body against disease and infection.

If the immune system malfunctions, it can mistakenly attack healthy cells,

tissues, and organs.

In response to an often-unknown trigger, the immune system starts producing antibodies that attack the body’s

own cells instead of fighting infections.

produced primarily by specific white blood cells, belongs to a category of proteins called cytokines that act as chemical messengers

throughout the body to regulate many aspects of the immune system.

Other key cytokines include IL-6, IL-17A, interleukin 10 (“IL-10”)

and Interferon gamma (“INFγ”).

Cytokines are essential to mounting an inflammatory response.

However, chronic or excessive

production of cytokines has been implicated in a number of acute and chronic inflammatory diseases.

number of drugs target the immunometabolic system to treat autoimmune diseases, including DMF (approved for the treatment of multiple

sclerosis) and Rapamycin (being studied in aging, rheumatoid arthritis, and other autoimmune diseases).

Additional therapies for autoimmune

diseases include anti-inflammatory drugs and immunosuppressive agents including drugs that non-selectively inhibit or block TNF-α

(generally referred to as “TNF-α blocking drugs”).

Currently available TNF-α blocking drugs must be injected

or infused to work.

In some instances, the efficacy of a given dosage of TNF-α blockers declines with repeated administration,

and side effects can also be a concern.

These non-selective TNF-α blockers can cause serious bacterial, fungal, and viral infections.

Isomyosamine is a selective, oral TNF-α inhibitor that might provide a safer alternative to existing products on the market.

market for TNF-α blockers was estimated at $41.6 billion in 2020 and is projected to reach $45.5 billion by 2027.

in vitro study involving human blood cells analyzed the cytokine inhibitory effects of Isomyosamine together with leading approved TNF-α

blockers (monoclonal antibodies).

Comparison of inhibitory effect of Isomyosamine with other TNF-α blockers.

Isomyosamine exhibits a dose-dependent reduction in release of

several cytokine more effectively than Humira, Enbrel and Remicade.

believe Isomyosamine is distinguishable from currently marketed TNF-α blockers because it selectively blocks TNF-α production related

to adaptive immunity (involved in autoimmunity) but spares the role of this cytokine in innate immunity (which plays a primary protective

role in fighting off invading organisms).

Because of the crucial role that TNF-α plays in front line protection by the innate immune

system (e.g., from bacterial, fungal, and viral infections), the indiscriminate blockade of TNF-α by TNF-α blocking agents

can cause serious and even fatal infections, which is one of the primary limiting factors in the use of this class of drugs.

our belief regarding the selectivity of Isomyosamine in blocking TNF-α, therefore, we intend to explore the extent to which Isomyosamine may

be a safer alternative to treat infectious, inflammatory, and autoimmune conditions, as well as its potential to ameliorate immune mediated

depression in such illnesses.

Study of Isomyosamine in Multiple Sclerosis Study (EAE Mouse Model)

sclerosis is an autoimmune disease in which T cells lead an attack on oligodendrocytes and neurons.

Multiple sclerosis is the leading

neurological cause of disability in adults aged 30–50, and approximately one million people in the United States are affected with

this debilitating disease.

T cells are one of the major components of the adaptive immune system.

Their roles include directly killing

infected host cells, activating other immune cells, producing cytokines and regulating the immune response.

When naïve, undifferentiated

T cells become activated, they differentiate and acquire effector functions that can be delineated by the cytokines they secrete.

in vivo studies of the therapeutic efficacy of Isomyosamine in the animal model for multiple sclerosis, known as EAE, indicate that

Isomyosamine modulates autoreactive T cell activation in a dose-dependent manner, suppresses T cell activation and ameliorates the course of

Further EAE mouse studies suggest that Isomyosamine suppresses the influx of CD4+ T cells into the brain.

Effects of Isomyosamine on the influx of T cells into the CNS early in EAE.

To assess the effects of Isomyosamine on the infiltration of T cells

into the CNS, mice were immunized and treated with either vehicle control or 25 mg/mouse/day Isomyosamine.

Ten to 14 days later, mice were

perfused and brains collected for analysis.

Infiltration was determined by flow cytometry.

Analysis of Th1 and Th17 subsets are shown;

data compiled from 2 to 3 experiments, n > 3/group per experiment).

Student’s t-test was conducted for statistics.

In Vivo Study of Autoimmune Thyroiditis (NODH.2 Mouse Model)

or Hashimoto thyroiditis is an autoimmune disease characterized by lymphocytic infiltration of the thyroid gland.

It has been shown that

tobacco smoking has a protective effect against Hashimoto thyroiditis as tobacco smokers have a lower prevalence of thyroid autoantibodies

than non-smokers.

conducted an in vivo study of autoimmune thyroiditis in a spontaneous thyroiditis (NODH.2) mouse model.

We believe the results

of this study show Isomyosamine’s ability to suppress TNF-α production by CD-4+ T cells in a dose dependent manner.

Additionally,

the study reported that Isomyosamine statistically decreases the incidence and severity (p <0.001) of thyroiditis in this mouse model.

studies have demonstrated that Isomyosamine ameliorated autoimmune thyroiditis in the thyroiditis mouse model.

Isomyosamine decreases the incidence and severity of autoimmune thyroiditis in NOD.H-2h4 mice, as assessed by H&E histopathology.

8 weeks old, 58 NOD.H-2h4 mice were divided into regular water and iodinated water groups.

In the regular water group, 10 mice (7 M,

3 F) drank water that contained Isomyosamine (185 mg/l), and 16 mice (10 M, 6 F) drank water without it.

In the iodinated water group, the

water was supplemented with 500 mg/l of sodium iodide and contained (16 mice:

10 M, 6 F) or did not contain (16 mice:

10 M, 6 F) Isomyosamine

After 12 weeks of treatment, thyroids were removed and divided in half.

(A and B) Thyroiditis severity and incidence assessed

by histopathology in the regular water group.

(D) A representative thyroid from a mouse in the regular water group treated with Isomyosamine, showing thyroid follicle preservation

and an overall normal glandular size (severity score of 0).

(E and F) Thyroiditis incidence and severity scores assessed by histopathology

in the iodinated water group.

(G) A representative thyroid from a mouse in the iodine group, showing marked lymphocytic infiltration,

follicular enlargement, and architectural disruption (severity score of 4).

(H) A representative thyroid from a mouse in the iodine plus

Isomyosamine group (severity score of 2).

Results represent the summary of 10 independent experiments, each analyzing 4 to 6 mice, for a total

Targets Inflamm-Aging and Related Disorders

is associated with a loss of tight regulation of the immune system.

This leads to increased inflammatory activity in the body, including

increased circulating levels of TNF-α.

Chronic inflammation is a hallmark of aging, referred to as inflamm-aging.

Inflamm-aging

and chronic inflammation are closely linked to a number of disorders such as obesity, insulin resistance/type 2 diabetes, cardiovascular

diseases, and cancers.

TNF-α is a multifunctional pro-inflammatory cytokine which may play a part in the pathogenesis of certain

age-related disorders such as atherosclerosis.

A multi-year pre-clinical, proof of concept in vivo study in aging and longevity

confirmed our belief regarding Isomyosamine’s potential therapeutic effect on inflamm-aging and other age-related disorders, which

we intend to explore further in clinical trials, pending our submission, and the corresponding acceptance, of the requisite regulatory

and other relevant submissions.

Commercialization Targets

is being developed to address serious and debilitating autoimmune and inflammatory diseases, including sarcopenia, frailty resulting

from aging process, and rheumatoid arthritis (RA).

According to the U.S.

Census Bureau, in 2020, there were approximately 54 million

residents over 65 years of age, representing 16% of the U.S.

This figure is expected to increase to nearly 22% by the

1 The Arthritis Foundation estimates that approximately 1.5 million people in the U.S.

is a synthetic small molecule that is an analog of naturally grown CBD derived from the Cannabis sativa plant.

Supera-CBD is being developed

to treat conditions with which CBD is often anecdotally associated but for which no natural or synthetic CBD-containing drugs have been

approved by the FDA, such as pain, anxiety/depression and seizures from epilepsy.

While naturally grown CBD is a constituent of Cannabis

sativa, Supera-CBD is a synthetic analog of CBD, thus eliminating potential complications associated with the psychoactive effects of

Tetrahydrocannabinol (“THC”), which is also a constituent of the Cannabis sativa plant.

Studies have suggested that CBD may

have broad therapeutic properties, including the treatment of neuropsychiatric disorders.

Department of Health and Human Services.

2020 Profile of Older Americans.

May 2021 Page 3.

The Arthritis Foundation.

Rheumatoid Arthritis:

Causes, Symptoms, Treatments and More.

Pharmacology and Therapeutic Profile

inhibits a number of important receptors, including the CB2 receptor and opioid receptors, and can also inhibit MAO enzymes.

In the immune

system, one of the important functions of the CB2 receptor is in the regulation of cytokine release from immune cells.

Antagonists targeting

the CB2 receptor have been proposed for the treatment or management of a range of painful conditions as well as for treating several

neurological diseases.

The Company conducted an in vitro binding assay study to analyze the CB2 inhibition of Supera-CBD together

with that of CBD derived from naturally grown plants.

receptors are widely expressed in the brain, spinal cord, peripheral nerves and digestive tract.

TNF conducted an in vitro binding

analysis of Supera-CBD with the three types of opioid receptors.

The profile suggests that Supera-CBD could possibly play a role in treating

opioid addiction.

are enzymes involved in the catabolism, or digestion, of certain neurotransmitters.

TNF conducted an in vitro MAO inhibition study.

In this study, Supera-CBD and commercial CBD were analyzed against positive and negative controls.

In this study, Supera-CBD far exceeded

CBD in dose-dependent inhibition of MAOs, particularly MAO-B.

Drugs that inhibit MAOs have been commercially used for decades to treat

depression, and more recent studies have suggested MAO-B inhibiting drugs might have a role to play in treating cognitive decline in

Early-Stage Plans for Development and Potential Commercialization Targets

is in early-stage development for pain, anxiety, and sleep disorders.

There are currently a number of over-the-counter CBD products

marketed with unapproved therapeutic claims relating to these conditions, among other conditions.

While there are a substantial

number of such products on the market that have not been subject to regulatory enforcement action, the FDA has consistently

reiterated, in guidance and warning letters against a number of the companies marketing such CBD products for such uses, that CBD

products may not be lawfully marketed for therapeutic uses in the United States without first-obtaining FDA approval via the NDA

CBD product sales in the US reportedly reached $5.3 billion in 2021, 15% growth over 2020 sales, and are projected to reach

$16 billion by 2026.

3 TNF believes that if Supera-CBD is approved by the FDA, it may have competitive advantages over

currently marketed CBD products that have not been approved by FDA as drug products, as approved drugs must undergo rigorous

premarket study and generate results sufficient to support a finding that they are safe and effective for their intended use(s) and

remain subject to ongoing FDA post market regulation, which provides additional assurances relating to quality, consistency and

there is one FDA-approved drug with plant-derived CBD as an active ingredient.

FDA subsequently approved three other cannabinoid-containing

drugs, two of which utilize synthetic cannabinoids analogous or similar to THC as the active ingredient and the other, a combination

of synthetic CBD and THC.

Epidiolex is being commercialized by GW Pharmaceuticals, plc (“GWPH”) to treat seizures associated

with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age and older.

The reported revenues from Epidiolex in fiscal

year 2019 were approximately $296 million.

The Company believes that, by utilizing synthetic, rather than naturally derived, CBD in Supera-CBD

may mitigate a number of obstacles generally associated with growing and processing an active drug ingredient produced from naturally

grown plant extracts.

March 2, 2023, we announced that the U.S.

Drug Enforcement Administration (DEA) has conducted a scientific review and determined that

it would not Supera-CBD a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.

We believe that this decision will expedite future research involving Supera-CBD by relieving us or our research partners from having

to comply with regulations relating to controlled substances.

US Hemp CBD Market To Hit $5.3B In Sales In 2021.

and Marketing

does not currently have sales and marketing infrastructure to support the launch of its products.

TNF intends to build such capabilities

in North America prior to launch the commercial Isomyosamine, if successfully developed and granted the requisite FDA approval.

North America, TNF may rely on licensing, co-sale and co-promotion agreements with strategic partners for commercialization of its products.

If TNF builds a commercial infrastructure to support marketing in North America, such commercial infrastructure could be expected to

include a targeted sales force supported by sales management, internal sales support, an internal marketing group and distribution support.

To develop the appropriate commercial infrastructure internally, TNF would have to invest financial and management resources, some of

which would have to be deployed prior to any confirmation that Isomyosamine or Supera-CBD will be approved, which cannot be guaranteed.

is a clinical stage small molecule that regulates the immunometabolic system to treat autoimmune

disease, including (but not limited to) sarcopenia, frailty, adverse effects of drugs used

to treat diabetes and obesity, rheumatoid arthritis, and inflammatory bowel disease.

first indication for which Isomyosamine is being developed is to treat age-related frailty

and sarcopenia.

Isomyosamine works by regulating the release of numerous pro-inflammatory

cytokines, such as TNF-α, interleukin 6 (“IL-6”) and interleukin 17 (“IL-17”).

Supera-CBD is a synthetic analog of CBD being developed to

treat various conditions, including, but not limited to, epilepsy, pain and anxiety/depression, through its effects on the CB2 receptor,

opioid receptors and monoamine oxidase enzyme (“MAO”) type B.

Company’s legacy pharmaceutical business has included activities such as preclinical testing, clinical trial planning and execution,

regulatory submissions and intellectual property development.

The Company continues to maintain its intellectual property portfolio and

certain operational capabilities associated with these programs.

Company is currently evaluating strategic alternatives for its legacy pharmaceutical business, which may include divestitures, licensing

transactions, partnerships or other arrangements.

These efforts are intended to optimize the value of these assets while allowing the

Company to focus resources on its laser-based computing business.

Company’s legacy pharmaceutical business is subject to substantial risks, including the inherent uncertainty of clinical development,

the potential for adverse regulatory outcomes, and the need for significant capital investment to advance therapeutic candidates.

future direction of this segment will depend on the outcome of the Company’s strategic review and its ability to execute transactions

or partnerships.

Company’s laser-based computing business targets opportunities across several large and evolving markets, including blockchain

infrastructure, artificial intelligence computing and photonic and optical computing technologies.

blockchain and cryptocurrency infrastructure market continues to expand as decentralized applications, tokenized assets, and distributed

networks gain broader adoption.

However, this market faces challenges related to energy consumption, scalability, and computational efficiency.

The Company believes that LPUs may provide a differentiated solution by enabling more efficient computation within these environments.

emergence of DePin Token ecosystems represents a growing segment focused on decentralizing physical infrastructure, including computing

These networks require scalable and energy-efficient computer solutions to support distributed workloads, and the Company

believes its technology may be well-suited to these applications.

parallel, demand for AI and high-performance computing continues to increase, driven by machine learning, data analytics, and optimization

Traditional computing architectures face limitations in power consumption and scalability, creating opportunities for alternative

approaches such as photonic computing.

in photonic integrated circuits and silicon photonics are further driving interest in optical computing technologies, which aim to overcome

the physical limitations of electronic systems.

The Company’s LPU-based approach is aligned with these trends.

Company’s ability to capitalize on these market opportunities will depend on successful technology development, competitive positioning

and market acceptance.

Company faces significant competition across both of its reportable segments.

the Company’s laser-based computing business, the Company competes with established semiconductor companies that produce CPUs,

GPUs, and specialized AI hardware, as well as with emerging companies developing photonic, optical, and quantum computing technologies.

In addition, companies providing blockchain infrastructure and decentralized computing solutions represent competitive alternatives.

These competitors often have substantial financial resources, established customer relationships, advanced manufacturing capabilities,

and significant research and development budgets.

Competitive factors include performance, energy efficiency, cost, scalability, reliability,

and the ability to integrate with existing systems.

biotechnology and biopharmaceutical industries are characterized by rapid evolution of technologies, fierce competition and vigorous

defense of intellectual property.

Any product candidates that TNF successfully develops and commercializes will have to compete with

existing and future new therapies.

While TNF believes that its drug candidates, development experience and scientific knowledge may provide

it with certain competitive advantages, TNF faces potential competition from many different sources, including major pharmaceutical,

specialty pharmaceutical and biotechnology companies, academic institutions, governmental agencies, and public and private research institutions.

therapies for autoimmune diseases include anti-inflammatory drugs and immunosuppressive agents, including drugs that seek to selectively

inhibit or block TNF-α (generally referred to as “TNF-α blocking drugs”).

TNF-α blocking drugs are large

molecules that are generally injected or infused.

In some instances, the period of efficacy of a given dosage of TNF-α blockers

can decline with repeated administration and side effects can be a concern.

Leading TNF-α blocking drugs include Etanercept (Enbrel),

Infliximab (Remicade), and Adalimumab (Humira).

The total TNF-α market collectively represented approximately $41 billion in global

sales in 2022.

4 All of these existing TNF-α blocking drugs require injection, whereas Isomyosamine is being developed to be

orally bioavailable.

Our management believes patients and providers would view the fact that Isomyosamine can be administered orally as a significant

currently marketed TNF-α blockers, Isomyosamine is designed to selectively block TNF-α production related to adaptive immunity

(involved in autoimmunity) but to spare the role of this cytokine in innate immunity (which plays the primary initial role in fighting

off invading organisms).

Because of the crucial role that TNF-α plays in front line protection by the innate immune system from

bacterial, fungal, and viral infections, the indiscriminate blockade of TNF-α by TNF-α blocking agents can cause serious

and even fatal infections, which is the primary limiting factor in the use of this class of drugs.

TNF thus believes that, if Isomyosamine

is approved for marketing, the potential selectivity of Isomyosamine in blocking TNF-α might make it a preferrable alternative to some

existing treatments for infectious, inflammatory, and autoimmune conditions, as well as simultaneously resulting in amelioration of immune

mediated depression in such illnesses if it is also approved for such indication.

https://www.thebusinessresearchcompany.com/report/tnf-alpha-inhibitor-global-market-report

policy is to develop and maintain TNF’s proprietary position by, among other methods, filing or in-licensing U.S.

and foreign patents

and applications related to TNF’s drug candidates and methods of treatment that are material to the development and implementation

of TNF’s business.

TNF also relies on trademarks, know-how, confidentiality agreements and invention assignment agreements to develop

and maintain TNF’s proprietary position.

patent portfolio includes protection for TNF’s lead product candidates, Isomyosamine and Supera-CBD.

Currently, there are multiple patent

families relating to (i) age reversal and treatments of age-related disorders including sarcopenia;

(ii) reduction of TNF-α levels

and treatments of autoimmune disorders;

The Company competes with biotechnology and pharmaceutical companies developing therapies targeting inflammatory

pathways, including TNF-α inhibitors, as well as companies developing cannabinoid-based therapeutics.

Many of these competitors

have greater experience in clinical development, regulatory approval and commercialization.

The Company’s

competitive position will depend on its ability to successfully develop its technologies, protect its intellectual property and execute

its business strategy.

Company’s intellectual property portfolio includes licensed technology from LightSolver as well as internally developed patents,

trade secrets, and proprietary know-how.

With respect to the

Company’s legacy pharmaceutical business, its patent portfolio includes protection for Isomyosamine and Supera-CBD.

there are multiple patent families relating to (i) age reversal and treatments of age-related disorders including sarcopenia;

reduction of TNF-α levels and treatments of autoimmune disorders;

(iii) addiction treatments;

and (iv) methods of increasing hair growth.

As of the date of this

document, TNF has 18 issued U.S.

and (iv) methods of increasing

As of December 31, 2025, the Company has 18 issued U.S.

patents, one pending U.S.

patent application, 69 issued foreign patents, and 5 foreign patent applications

pending in such jurisdictions as Canada, China, Israel, and Japan which, if issued, are expected

to expire between 2036 and 2041.

term of individual patents depends upon the legal term of the patents in the countries in which they are obtained.

In most countries

in which TNF files, the patent term is 20 years from the date of filing of the first non-provisional application in which priority is

patent term may be lengthened by patent term adjustment, which compensates a patentee for administrative delays

by the USPTO in granting a patent or may be shortened if a patent is terminally disclaimed over an earlier-filed patent.

the term of a patent that covers an FDA-approved drug may also be eligible for a patent term extension of up to five years under the

Hatch-Waxman Act, which is designed to compensate for the patent term lost during the FDA regulatory review process.

The length of the

patent term extension involves a complex calculation based on the length of time it takes for regulatory review.

A patent term extension

under the Hatch-Waxman Act cannot extend the remaining term of a patent beyond a total of 14 years from the date of product approval

and only one patent applicable to an approved drug may be extended.

Moreover, a patent can only be extended once, and thus, if a single

patent is applicable to multiple products, it can only be extended based on one product.

Similar provisions are available in Europe and

certain other foreign jurisdictions to extend the term of a patent that covers an approved drug.

commercial success depends in part on its ability to obtain and maintain proprietary protection for TNF’s product candidates, as

well as novel discoveries, core technologies, and know-how, as well as its ability to operate without infringing on the proprietary rights

of others and to prevent others from infringing its proprietary rights.

and Royalty Agreements

is a party to two Amended and Restated Confirmatory Patent Assignment and Royalty Agreements, both dated November 11, 2020, with SRQ

Patent Holdings and SRQ Patent Holdings II, under which TNF (or its successor) will be obligated to pay to SRQ Patent Holdings or SRQ

Patent Holdings II (or its designees) certain royalties on product sales or other revenue received on products that incorporate or are

covered by the intellectual property that was assigned to TNF.

The royalty is equal to 8% of the net sales price on product sales and,

without duplication, 8% of milestone revenue or sublicense compensation.

SRQ Patent Holdings and SRQ Patent Holdings II are affiliates

authorities in the U.S.

at the federal, state, and local level and in other countries regulate, among other things, the research, development,

testing, manufacture, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution,

post-approval monitoring and reporting, marketing and export and import of drugs and biological products.

Generally, before a new drug

can be marketed, considerable data demonstrating its quality, safety, and efficacy in connection with the target indication(s) for use

must be obtained, organized into a format specific for each regulatory authority, submitted for review and approved by the regulatory

Approval Process

the U.S., pharmaceutical products are subject to extensive regulation under the Food, Drug & Cosmetic Act (“FD&C Act”) and the FDA’s implementing regulations

and other federal and state statutes and regulations governing, among other things, the research, development, testing, manufacture,

storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling and

import and export of pharmaceutical products.

Failure to comply with applicable U.S.

requirements may subject a company to a variety

enforcement actions and/or administrative or judicial sanctions, including, but not limited to clinical holds, FDA refusal to approve

NDA submissions and/or revocation or limitation of existing NDAs for approved products, warning or untitled letters, product recalls,

product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties and criminal prosecution.

Pharmaceutical

product development for a new drug product or certain changes to an approved product in the U.S.

typically requires pre-clinical laboratory

and animal tests, the submission to the FDA of an IND, which must become effective before clinical testing on human subjects may commence,

and adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug for each indication for which

FDA approval is sought.

Satisfaction of FDA pre-market approval requirements are inherently uncertain, expensive, and it typically takes

many years to generate sufficient data to apply for approval, even when such approval is not ultimately granted, and the actual time

required may vary substantially based upon the type, complexity and novelty of the product or disease.

tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics

and potential safety and efficacy of the product.

The conduct of the pre-clinical tests must comply with federal regulations and requirements,

including good laboratory practices.

The results of pre-clinical testing are submitted to the FDA as part of an IND along with other

information, including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol.

pre-clinical tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.

waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans.

If the FDA has neither

commented on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin.

Clinical trials involve

the administration of the new investigational drug to healthy volunteers or patients under the supervision of a qualified investigator.

Clinical trials must be conducted:

(i) in compliance with federal regulations;

(ii) in compliance with Good Clinical Practices (“GCP”), an international standard

meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators and monitors;

(iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria

to be evaluated.

Each protocol involving testing on U.S.

patients and subsequent protocol amendments must be submitted to the FDA as

part of the IND.

FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time, or impose other sanctions, if it believes

that the clinical trial either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical

trial patients.

The study protocol and informed consent information for patients in clinical trials must also be submitted to an IRB

and ethics committee for approval.

The IRB will also monitor the clinical trial until it is completed.

An IRB may also require the clinical

trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements, or may impose

other conditions.

Additionally, some clinical trials are overseen by an independent group of qualified experts organized by the clinical

trial sponsor, known as a data safety monitoring board or committee.

This group provides authorization for whether a trial may move forward

at designated checkpoints based on access to certain data from the trial.

trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap.

1, the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess metabolism, pharmacokinetics,

pharmacological actions, side effects associated with increasing doses, and, if possible, early evidence of effectiveness.

Phase 2 usually

involves trials in a limited patient population to determine the effectiveness of the drug for a particular indication, dosage tolerance

and optimum dosage, and to identify common adverse effects and safety risks.

If a drug demonstrates evidence of effectiveness and an

acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain the additional information about clinical efficacy

and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate

the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug.

In most cases the

FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the drug.

A single Phase 3 trial

may be sufficient in rare instances, including (1) where the trial is a large multicenter trial demonstrating internal consistency and

a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible morbidity or prevention of a disease

with a potentially serious outcome and confirmation of the result in a second trial would be practically or ethically impossible or (2)

when in conjunction with other confirmatory evidence.

manufacturer of an investigational drug in a Phase 2 or 3 clinical trial for a serious or life-threatening disease is required to make

available, such as by posting on its website, its policy on evaluating and responding to requests for expanded access.

completion of the required clinical testing, an NDA is prepared and submitted to the FDA.

FDA approval of the NDA is required before

marketing of the product may begin in the U.S.

The NDA must include the results of all pre-clinical, clinical and other testing and a

compilation of data relating to the product’s pharmacology, chemistry, manufacture and controls.

The cost of preparing and submitting an NDA is substantial.

The submission

of most NDAs is additionally subject to a substantial application user fee, currently exceeding $4.3 million for fiscal year 2025 and

$4 million for fiscal year 2024 (for applications containing clinical data), which increased from $3.2 million for fiscal year 2023.

waivers or reductions are available in certain circumstances, including a waiver of the application fee for the first application filed

by a small business.

Additionally, no user fees are assessed on NDAs for products designated as orphan drugs, unless the product also

includes a non-orphan indication.

The applicant under an approved NDA is also subject to annual program fees, currently $416,734 for fiscal

year 2024 for each prescription product and $403,889 for fiscal year 2025.

for each prescription product.

The FDA adjusts the user fees

on an annual basis, and the fees typically increase annually.

FDA reviews each submitted NDA before it determines whether to file it and may request additional information.

The FDA must make a decision

on whether to file an NDA within 60 days of receipt, and such decision could include a refusal to file by the FDA.

Once the submission

is filed, the FDA begins an in-depth review of the NDA.

The FDA has agreed to certain performance goals in the review of NDAs.

Most applications

for standard review drug products are reviewed within ten to twelve months; most applications for priority review drugs are reviewed

in six to eight months.

Priority review can be applied to drugs that the FDA determines may offer significant improvement in safety or

effectiveness compared to marketed products or where no adequate therapy exists.

The review process for both standard and priority review

may be extended by the FDA for three additional months to consider certain late-submitted information, or information intended to clarify

information already provided in the submission.

The FDA does not always meet its goal dates for standard and priority NDAs, and the review

process can be extended by FDA requests for additional information or clarification.

FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to

an outside advisory committee—typically a panel that includes clinicians and other experts—for review, evaluation and a recommendation

as to whether the application should be approved and under what conditions, if any.

The FDA is not bound by the recommendation of an

advisory committee, but it generally follows such recommendations.

approving an NDA, the FDA will conduct a pre-approval inspection of the manufacturing facilities for the new product to determine whether

they comply with Current Good Manufacturing Practice (“cGMP”) requirements.

The FDA will not approve the product unless it determines that the manufacturing processes and facilities

are in compliance with cGMP requirements and are adequate to assure consistent production of the product within required specifications.

The FDA also typically inspects clinical trial sites to ensure compliance with GCP requirements and the integrity of the data supporting

safety and efficacy.

the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter (“CRL”).

A CRL generally outlines the deficiencies in the submission, which may be minor and more technical, or major and more substantive and,

in the latter case may require substantial additional testing or data to be eligible for substantive review by FDA upon resubmission,

such as additional clinical data, additional pivotal clinical trial(s), and/or other significant and time-consuming requirements related

to clinical trials, pre-clinical studies or manufacturing.

If a CRL is issued, the applicant may resubmit the NDA addressing all of the

deficiencies identified in the letter, withdraw the application, engage in formal dispute resolution or request an opportunity for a

The FDA has committed to reviewing resubmissions in two to six months depending on the type of information included.

such data and information are submitted, the FDA may decide that the NDA does not satisfy the criteria for approval.

the deficiencies identified in the CRL are addressed to FDA’s satisfaction in a resubmission of the NDA (and FDA does not identify

any other issues that need to be corrected prior to approval or that, otherwise, cause the agency to determine that approval is not appropriate

at the given time), the FDA will issue an approval letter.

An approval letter authorizes commercial marketing of the drug with specific

prescribing information for specific indications.

In addition, under the Pediatric Research Equity Act of 2003 (“PREA”),

as amended and reauthorized, certain NDAs or supplements to an NDA must contain data that are adequate to assess the safety and effectiveness

of the drug for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric

subpopulation for which the product is safe and effective.

The FDA may, on its own initiative or at the request of the applicant, grant

deferrals for submission of some or all pediatric data until after approval of the product for use in adults, or full or partial waivers

from the pediatric data requirements.

a condition of NDA approval, the FDA may also require a REMS, to help ensure that the benefits of the drug outweigh the potential risks

A REMS can include medication guides, communication plans for healthcare professionals, and elements to assure safe use

ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing

only under certain circumstances, special monitoring, and the use of patient registries.

The requirement for a REMS can materially affect

the potential market and profitability of the drug.

Moreover, product approval may require substantial post-approval testing and surveillance

to monitor the drug’s safety or efficacy.

Once granted, product approvals may be withdrawn if compliance with regulatory standards

is not maintained or problems are identified following initial marketing.

to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes

or facilities, require submission and FDA approval of an NDA supplement or, in some case, a new NDA, before the change can be implemented.

An NDA supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses

the same procedures and actions in reviewing NDA supplements as it does in reviewing NDAs.

of Clinical Trial Information

of clinical trials of FDA regulated products, including drugs, are required to register and disclose certain clinical trial information

public by publishing such information on clinicaltrials.gov.

Information related to the product, patient population, phase

of investigation, study sites and investigators, and other aspects of the clinical trial is then made public as part of the registration.

Sponsors are also obligated to discuss the results of their clinical trials after completion.

Disclosure of the results of these trials

can be delayed in certain circumstances for up to two years after the date of completion of the trial.

Competitors may use this publicly

available information to gain knowledge regarding the progress of development programs.

Development and Review Programs

FDA is authorized to designate certain products for expedited review if they are intended to address an unmet medical need in the treatment

of a serious or life-threatening disease or condition.

These programs are fast track designation, breakthrough therapy designation, and

priority review designation.

TNF has not applied for expedited approval under any of these pathways to date but intends to explore the

extent to which any of its current or future product candidates may be eligible for one or more such pathways.

There is no guarantee

that FDA will grant any of TNF’s products candidates the expedited designation(s) for which it is submitted, if any, or that TNF

will secure any of the applicable benefits associated with any of any expedited designations that may be granted to its current or future

product candidates, if applicable.

track designation may be granted for a product that is intended to treat a serious or life-threatening disease or condition for which

pre-clinical or clinical data demonstrate the potential to address unmet medical needs for the condition.

The sponsor of an investigational

drug product may request that the FDA designate the drug candidate for a specific indication as a fast-track drug concurrent with, or

after, the submission of the IND for the drug candidate.

The FDA must determine if the drug candidate qualifies for fast-track designation

within 60 days of receipt of the sponsor’s request.

For fast-track products, sponsors may have greater interactions with the FDA

and the FDA may initiate review of sections of a fast-track product’s NDA before the application is complete.

This rolling review

is available if the FDA determines, after preliminary evaluation of clinical data submitted by the sponsor, that a fast-track product

may be effective.

The sponsor must also provide, and the FDA must approve, a schedule for the submission of the remaining information

and the sponsor must pay applicable user fees.

At the time of NDA filing, the FDA will determine whether to grant priority review designation.

Additionally, fast track designation may be withdrawn if the FDA believes that the designation is no longer supported by data emerging

in the clinical trial process.

Therapy Designation

2012, Congress enacted the Food and Drug Administration Safety and Innovation Act, or FDASIA.

This law established a new regulatory scheme

allowing for expedited review of products designated as “breakthrough therapies.” A product may be designated as a breakthrough

therapy if it is intended, either alone or in combination with one or more other drugs, to treat a serious or life-threatening disease

or condition and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies

on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

may take certain actions with respect to breakthrough therapies, including holding meetings with the sponsor throughout the development

providing timely advice to the product sponsor regarding development and approval;

involving more senior staff in the review

assigning a cross-disciplinary project lead for the review team;

and taking other steps to design the clinical trials in an

efficient manner.

Review Designation

FDA may designate a product for priority review if it is a drug that treats a serious condition and, if approved, would provide a significant

improvement in safety or effectiveness.

The FDA determines, on a case- by-case basis, whether the proposed drug represents a significant

improvement when compared with other available therapies.

Significant improvement may be illustrated by evidence of increased effectiveness

in the treatment of a condition, elimination or substantial reduction of a treatment-limiting drug reaction, documented enhancement of

patient compliance that may lead to improvement in serious outcomes, and evidence of safety and effectiveness in a new subpopulation.

A priority designation is intended to direct overall attention and resources to the evaluation of such applications, and to shorten the

FDA’s goal for taking action on a marketing application from ten months to six months.

approval may be granted for a product that is intended to treat a serious or life-threatening condition and that generally provides a

meaningful therapeutic advantage to patients over existing treatments.

A product eligible for accelerated approval may be approved on

the basis of either a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be

measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or

mortality or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability or

lack of alternative treatments.

The accelerated approval pathway is most often used in settings in which the course of a disease is long,

and an extended period of time is required to measure the intended clinical benefit of a product, even if the effect on the surrogate

or intermediate clinical endpoint occurs rapidly.

The accelerated approval pathway is contingent on a sponsor’s agreement to conduct

additional post-approval confirmatory studies to verify and describe the product’s clinical benefit.

These confirmatory trials

must be completed with due diligence and, in some cases, the FDA may require that the trial be designed, initiated, and/or fully enrolled

prior to approval.

Failure to conduct required post-approval studies, or to confirm a clinical benefit during post-marketing studies,

would allow the FDA to withdraw the product from the market on an expedited basis.

All promotional materials for product candidates approved

under accelerated regulations are subject to prior review by the FDA.

Post-marketing

approval of a new product, the manufacturer and the approved product are subject to continuing regulation by the FDA.

Drug manufacturers’

and/or sponsors’ post-marketing FDA obligations, include, among other things, monitoring and record-keeping activities, reporting

of adverse experiences, complying with promotion and advertising requirements, which include restrictions on promoting products for unapproved

uses or patient populations (known as “off-label use”) and limitations on industry-sponsored scientific and educational activities,

and a number of other specific requirements for prescription-drug advertising.

Although physicians may prescribe legally available products

for off-label uses, manufacturers may not market or promote their approved drug products for off-label uses.

Product approvals may be

withdrawn for non-compliance with regulatory standards or if problems occur following initial marketing.

Newly discovered or developed

safety or effectiveness data may require changes to a product’s approved labeling, including the addition of new warnings and contraindications,

and may also require the implementation of other risk management measures, including a REMS, or the conduct of post-marketing studies

to assess a newly discovered safety issue.

regulations require that drug products be manufactured in registered drug-manufacturing facilities and in accordance with cGMP regulations.

The Company currently relies on third parties to produce clinical quantities of its drug candidates under development in accordance with applicable

GCPs and Good Laboratory Practices (“GLPs”), and expects to continue to rely, on third parties to produce clinical and commercial quantities of the Company’s products

that are approved for marketing in the United States, if any, in accordance with cGMP regulations.

These manufacturers must comply with

cGMP regulations that require, among other things, quality control and quality assurance, the maintenance of records and documentation

and the obligation to investigate and correct any deviations from cGMP.

Accordingly, manufacturers must continue to expend time, money

and effort in the area of production and quality control to maintain cGMP compliance.

The discovery of violative conditions, including

failure to conform to cGMP regulations, could result in a wide range of enforcement actions against the manufacturer, including, but

not limited to, recalls, warning letters, “dear doctor” letters, civil lawsuits, fines, and criminal prosecution.

discovery of previously unknown safety or efficacy problems with a product after approval may result in restrictions on, revocation of,

or the addition of conditions to the product’s approval, among other potential adverse actions.

addition to the requirements applicable to approved drug products, sponsors may also be subject to enforcement action in connection with

any promotion of any investigational new drug.

A sponsor or investigator, or any person acting on behalf of a sponsor or investigator,

may not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under

investigation or otherwise promote or market the product.

Regulatory Matters

Manufacturing,

sales, promotion and other activities following product approval are also subject to regulation by numerous regulatory authorities in

in addition to the FDA, including the Centers for Medicare and Medicaid Services, other divisions of the U.S.

Department of Health and Human Services, the Department of Justice, the Drug Enforcement Administration, the Consumer

Product Safety Commission, the Federal Trade Commission, the Occupational Safety & Health Administration, the Environmental Protection

Agency and state and local governments and governmental agencies.

Healthcare Laws

providers, physicians, and third-party payors will play a primary role in the recommendation and prescription of any products for which

TNF may obtain marketing approval.

TNF’s current and future arrangements with third-party payors, healthcare providers and physicians

may expose TNF to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial

arrangements and relationships through which TNF markets, sells and distributes any drugs for which the Company obtains marketing approval.

In the U.S., these laws include, without limitation, state and federal anti-kickback, false claims, physician transparency, and patient

data privacy and security laws and regulations, including but not limited to those described below.

The Company’s business operations,

including its research, marketing, and activities relating to the reporting of wholesale or estimated retail prices for TNF’s products,

the reporting of prices used to calculate Medicaid rebate information and other information affecting federal, state, and third-party

reimbursement for TNF’s products, and the sale and marketing of TNF’s product and any future product candidates, are subject

to scrutiny under these laws.

AKS, makes it illegal for any person, including a prescription drug manufacturer (or a party acting on its behalf), to knowingly

and willfully solicit, receive, offer or pay any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, that

is intended to induce or reward referrals, including the purchase, recommendation, order or prescription of a particular drug, for

which payment may be made under a federal healthcare program, such as Medicare or Medicaid.

Violations of this law are punishable

by imprisonment, criminal fines, administrative civil money penalties and exclusion from participation in federal healthcare programs.

In addition, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it.

federal civil and criminal false claims laws, including the federal False Claims Act (“FCA”), which can be enforced through civil whistleblower or qui tam actions,

which impose penalties against individuals or entities (including manufacturers) for, among other things, knowingly presenting, or

causing to be presented false or fraudulent claims for payment by a federal healthcare program or making a false statement or record

material to payment of a false claim or avoiding, decreasing or concealing an obligation to pay money to the federal government.

The government may deem manufacturers to have “caused” the submission of false or fraudulent claims by, for example,

providing inaccurate billing or coding information to customers or promoting a product off-label.

Claims that include items or services

resulting from a violation of the AKS are false or fraudulent claims for purposes of the FCA.

federal anti-inducement law, which prohibits, among other things, the offering or giving of remuneration, which includes, without

limitation, any transfer of items or services for free or for less than fair market value (with limited exceptions), to a Medicare

or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular

supplier of items or services reimbursable by a federal or state governmental program.

The Health Insurance Portability and Accountability Act (“HIPAA”)

imposes criminal and civil liability for knowingly and willfully executing a scheme, or attempting to execute a scheme, to defraud

any healthcare benefit program, including private payors, or falsifying, concealing or covering up a material fact or making any

materially false statements in connection with the delivery of or payment for healthcare benefits, items or services.

the AKS, a person or entity does not need to have actual knowledge of the healthcare fraud statute implemented under HIPAA or specific

intent to violate it in order to have committed a violation.

as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and their respective

implementing regulations, imposes, among other things, specified requirements on covered entities and their business associates relating

to the privacy and security of individually identifiable health information including mandatory contractual terms and required implementation

of technical safeguards of such information.

HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil

and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions

for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated

with pursuing federal civil actions.

federal Physician Payment Sunshine Act of 2021 (“PPSA”), enacted as part of the Patient Protection and Affordable Care Act (“ACA”), imposed new annual reporting requirements for certain manufacturers of drugs, devices, biologics,

and medical supplies for which payment is available under Medicare, Medicaid, or the Children’s Health Insurance Program, for

certain payments and “transfers of value” provided to physicians (defined to include doctors, dentists, optometrists,

podiatrists and chiropractors) and teaching hospitals, as well as ownership and investment interests held by physicians and their

immediate family members.

Effective January 1, 2022, these reporting obligations extend to include transfers of value made during

the previous year to certain non-physician providers such as physician assistants and nurse practitioners.

state and foreign fraud and abuse laws and regulations, such as state anti-kickback and false claims laws, which may be broader in

scope and apply regardless of payor.

These laws are enforced by various state agencies and through private actions.

Some state laws

require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant

federal government compliance guidance, require drug manufacturers to report information related to payments and other transfers

of value to physicians and other healthcare providers, and restrict marketing practices or require disclosure of marketing expenditures.

In addition, certain state and local laws require the registration of pharmaceutical sales representatives.

and foreign laws also govern the privacy and security of health information in some circumstances.

These data privacy and security laws

may differ from each other in significant ways and often are not pre-empted by HIPAA, which may complicate compliance efforts.

most states in the United States have enacted laws regulating the confidentiality and security of medical information and increased public

focus on privacy may result in amendments or changes to these laws in ways that may have an impact on TNF’s business activities

related to the collection and use of health-related information.

increased attention on privacy in the United States may also impact TNF’s business activities for the processing of personal

information not otherwise governed by HIPAA.

The EU General Data Protection Regulation (“GDPR”) imposes significant

privacy and cybersecurity requirements related to the handling of all types of personal information, with heightened requirements on

sensitive personal information, such as health information.

The GDPR imposes significant limitations on the use of this personal

information and grants individuals in the EU certain rights associated with the collection and use of personal information.

U.S., California enacted the CCPA, which creates new individual privacy rights for California consumers (generally defined as any

resident of California, including employees and other business relations) and places increased privacy and security obligations on

entities handling personal information of consumers or households.

The CCPA also greatly extends the obligations of entities that

process personal information to include information not traditionally viewed as personal information and regulated by laws, such as

Internet Protocol (IP) addresses, unique identifiers for individuals, and information in online cookies and other online

technologies.

A majority of other states have already proposed or enacted laws similar to the CCPA, each differing in scope of the

personal information covered and the rights of individuals.

Furthermore, the CCPA has already been amended with the passage of

California’s Proposition 24 (the California Privacy Rights Act, “CPRA”), which adds additional rights and

While the CCPA and CPRA currently provide relatively broad exclusions for protected health information regulated by

HIPAA and clinical trials and a limited exception for consumer and business to business information, some of the proposed and

enacted laws in other states may not contain the same exceptions.

Furthermore, there have been a number of competing proposals for

federal laws, some of which propose to not preempt other state laws.

The uncertainty surrounding new proposed and changes to

existing privacy laws may lead to operational challenges for TNF to comply with multiple, potentially conflicting, privacy and

cybersecurity laws related to the collection and use of personal information in each jurisdiction.

state and federal laws and regulations also require entities to implement “reasonable” or “adequate” security

measures to protect personal information but generally do not provide any specific sets of security measures that would be considered

compliant to avoid liability.

Instead, different regulators have adopted inconsistent and evolving standards based on the regulator’s

view of what is appropriate given the nature and scope of the personal information and the processing performed, resulting in unclear

This may result in potential liability if a regulator finds that TNF’s security practices do not meet or exceed the

types of security measures that the regulator believes to be adequate or reasonable under the circumstances.

scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform,

especially considering the lack of applicable precedent and regulations.

Federal and state enforcement bodies have continued to increase

their scrutiny of interactions between healthcare companies and healthcare providers, which has led to investigations, prosecutions,

convictions and settlements in the healthcare industry.

It is possible that governmental authorities will conclude that TNF’s business

practices do not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare

laws and regulations.

If TNF’s operations are found to be in violation of any of these laws or any other related governmental regulations

that may apply to it, TNF may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, disgorgement,

exclusion of drugs from government funded healthcare programs, such as Medicare and Medicaid, reputational harm, additional oversight

and reporting obligations if TNF becomes subject to a corporate integrity agreement or similar settlement to resolve allegations of non-compliance

with these laws and the curtailment or restructuring of TNF’s operations.

If any of the physicians or other healthcare providers

or entities with whom TNF expects to do business is found to be not in compliance with applicable laws, they may be subject to similar

actions, penalties and sanctions.

Ensuring business arrangements comply with applicable healthcare laws, as well as responding to possible

investigations by government authorities, can be time- and resource-consuming and can divert a company’s attention from its business.

and Future Healthcare Reform Legislation

March 23, 2010, President Obama signed the “Patient Protection and Affordable Care Act” (P.L.

111-148) (the “ACA”)

and on March 30, 2010, he signed the “Health Care and Education Reconciliation Act” (P.L.

111-152), collectively commonly

referred to as the “Healthcare Reform Law.” The Healthcare Reform Law included a number of new rules regarding health insurance,

the provision of healthcare, conditions to reimbursement for healthcare services provided to Medicare and Medicaid patients, and other

healthcare policy reforms.

Through the law-making process, substantial changes have been and continue to be made to the current system

for paying for healthcare in the U.S., including changes made to extend medical benefits to certain Americans who lacked insurance coverage

and to contain or reduce healthcare costs (such as by reducing or conditioning reimbursement amounts for healthcare services and drugs,

and imposing additional taxes, fees, and rebate obligations on pharmaceutical and medical device companies).

This legislation was one

of the most comprehensive and significant reforms ever experienced by the U.S.

in the healthcare industry and has significantly changed

the way healthcare is financed by both governmental and private insurers.

This legislation has impacted the scope of healthcare insurance

and incentives for consumers and insurance companies, among others.

Additionally, the Healthcare Reform Law’s provisions were designed

to encourage providers to find cost savings in their clinical operations.

Pharmaceuticals represent a significant portion of the cost

of providing care.

This environment has caused changes in the purchasing habits of consumers and providers and resulted in specific attention

to the pricing negotiation, product selection and utilization review surrounding pharmaceuticals.

This attention may result in our product

candidates, to the extent approved for commercialization in the future, being chosen less frequently or the pricing being substantially

At this stage, it is difficult to estimate the full extent of the direct or indirect impact of the Healthcare Reform Law on

structural changes could entail further modifications to the existing system of private payors and government programs (such as Medicare,

Medicaid, and the State Children’s Health Insurance Program), creation of government-sponsored healthcare insurance sources, or

some combination of both, as well as other changes.

Restructuring the coverage of medical care in the U.S.

could impact the reimbursement

for prescribed drugs and pharmaceuticals, including any products that we may commercialize or promote in the future.

If reimbursement

for the products we may commercialize or promote in the future is substantially reduced or otherwise adversely affected in the future,

or rebate obligations associated with them are substantially increased, it could have a material adverse effect on our reputation, business,

financial condition or results of operations.

medical benefits to those who currently lack coverage will likely result in substantial costs to the U.S.

federal government, which may

force significant additional changes to the healthcare system in the U.S.

Much of the funding for expanded healthcare coverage may be

sought through cost savings.

While some of these savings may come from realizing greater efficiencies in delivering care, improving the

effectiveness of preventive care and enhancing the overall quality of care, much of the cost savings may come from reducing the cost

of care and increased enforcement activities.

Cost of care could be reduced further by decreasing the level of reimbursement for medical

services or products or by restricting coverage (and, thereby, utilization) of medical services or products.

In either case, a reduction

in the utilization of, or reimbursement for any product we may commercialize or promote in the future, could have a material adverse

effect on our reputation, business, financial condition or results of operations.

states and private entities initially mounted legal challenges to the Healthcare Reform Law, in particular, the ACA, and they continue

to litigate various aspects of the legislation.

In June 2012, the U.S.

Supreme Court generally upheld the provisions of the ACA at

issue as constitutional.

However, the U.S.

Supreme Court held that the legislation improperly required the states to expand their Medicaid

programs to cover more individuals.

As a result, states have a choice as to whether they will expand the number of individuals covered

by their respective state Medicaid programs.

Some states have not expanded their Medicaid programs and have chosen to develop other cost-saving

and coverage measures to provide care to currently uninsured individuals.

Many of these efforts to date have included the institution

of Medicaid-managed care programs.

The manner in which these cost-saving and coverage measures are implemented could have a material

adverse effect on our reputation, business, financial condition or results of operations.

the healthcare regulatory environment has seen significant changes in recent years and is still in flux.

Legislative initiatives to modify,

limit, replace, or repeal the ACA and judicial challenges have continued.

We cannot predict the impact on our business of future legislative

and legal challenges to the ACA or other aspects of the Healthcare Reform Law or other changes to the current laws and regulations.

financial impact of U.S.

healthcare reform legislation over the next few years will depend on a number of factors, including the policies

reflected in implementing regulations and guidance and changes in sales volumes for therapeutics affected by the legislation.

to time, legislation is drafted, introduced and passed in the U.S.

Congress that could significantly change the statutory provisions

governing coverage, reimbursement, and marketing of pharmaceutical products.

In addition, third-party payor coverage and reimbursement

policies are often revised or interpreted in ways that may significantly affect our business and our products.

the first administration, President Trump supported the repeal of all or portions of the ACA.

President Trump also issued an executive

order in which he stated that it is his administration’s policy to seek the prompt repeal of the ACA and in which he directed executive

departments and federal agencies to waive, defer, grant exemptions from, or delay the implementation of the provisions of the ACA to

the maximum extent permitted by law.

Congress has enacted legislation that repeals certain portions of the ACA, including but not limited

to the Tax Cuts and Jobs Act, passed in December 2017, which included a provision that eliminates the penalty under the ACA’s individual

mandate, effective January 1, 2019, as well as the Bipartisan Budget Act of 2018, passed in February 2018, which, among other things,

repealed the Independent Payment Advisory Board (which was established by the ACA and was intended to reduce the rate of growth in Medicare

Additionally,

in December 2018, a district court in Texas held that the individual mandate is unconstitutional and that the rest of the ACA is, therefore,

On appeal, the Fifth Circuit Court of Appeals affirmed the holding on the individual mandate but remanded the case back to the

lower court to reassess whether and how such holding affects the validity of the rest of the ACA.

The Fifth Circuit’s decision

on the individual mandate was appealed to the U.S.

Supreme Court.

On June 17, 2021, the Supreme Court held that the plaintiffs (comprised

of the state of Texas, as well as numerous other states and certain individuals) did not have standing to challenge the constitutionality

of the ACA’s individual mandate and, accordingly, vacated the Fifth Circuit’s decision and instructed the district court

to dismiss the case.

As a result, the ACA will remain in-effect in its current form for the foreseeable future;

however, we cannot predict

what additional challenges may arise in the future, the outcome thereof, or the impact any such actions may have on our business.

Biden administration also introduced various measures in 2021 focusing on healthcare and drug pricing, in particular.

on January 28, 2021, former President Biden issued an executive order that initiated a special enrollment period for purposes of

obtaining health insurance coverage through the ACA marketplace, which began on February 15, 2021, and remained open through August

The executive order also instructed certain governmental agencies to review and reconsider their existing policies and

rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that

include work requirements and policies that create unnecessary barriers to obtaining access to health insurance coverage through

Medicaid or the ACA.

On the legislative front, the American Rescue Plan Act of 2021 was signed into law on March 11, 2021, which, in

relevant part, eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer

price, for single source drugs and innovator multiple source drugs, beginning January 1, 2024.

And, in July 2021, the Biden

administration released an executive order entitled, “Promoting Competition in the American Economy,” with multiple

provisions aimed at prescription drugs.

In response, on September 9, 2021, HHS released a “Comprehensive Plan for Addressing

High Drug Prices” that outlines principles for drug pricing reform and sets out a variety of potential legislative policies

that Congress could pursue as well as potential administrative actions HHS can take to advance these principles.

And, on August 16,

2022, former President Biden signed into law the Inflation Reduction Act of 2022, which aims to lower prescription drug pricing by,

among other things, allowing Medicare to negotiate prices for certain high-cost prescription drugs covered under Medicare Part D and

Part B after the drugs have been on the market for a certain number of years and requiring on drug manufacturers to pay rebates if

they increase drug prices “faster than inflation.” Additional legislative and regulatory changes

could be made to governmental health programs that could significantly impact pharmaceutical companies and the success of our

product candidates.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to

control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions

on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage

importation from other countries and bulk purchasing.

is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal and/or state level in the

United States or the effect of any future legislation or regulation.

Furthermore, we cannot assess the impact that President

Trump’s second term will have on healthcare programs and regulations or the pharmaceutical industry in general.

However, it is

possible that such initiatives could have an adverse effect on our ability to obtain approval and/or successfully commercialize

products in the United States in the future.

For example, any changes that reduce, or impede the ability to obtain, reimbursement

for our product candidates approved for commercialization in the United States, if any, or any other drug products we may

commercialize in the future or that reduce medical procedure volumes could adversely affect our operations and/or future business

and Distribution in the United States

TNF’s product candidates that are approved for commercialization in the United States, if any, are made available to authorized

users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements may apply.

part, products must meet applicable child-resistant packaging requirements under the U.S.

Poison Prevention Packaging Act.

Manufacturing,

sales, promotion and other activities also are potentially subject to federal and state consumer protection and unfair competition laws.

distribution of pharmaceutical products is subject to additional requirements and regulations, including extensive record-keeping, licensing,

storage and security requirements intended to prevent the unauthorized sale of pharmaceutical products.

failure to comply with any of these laws or regulatory requirements subjects firms to possible legal or regulatory action.

on the circumstances, failure to meet applicable regulatory requirements can result in criminal prosecution, fines or other penalties,

injunctions, exclusion from federal healthcare programs, requests for recall, seizure of products, total or partial suspension of production,

denial or withdrawal of product approvals, or refusal to allow a firm to enter into supply contracts, including government contracts.

Any action against TNF for violation of these laws, even if TNF is successful in defending against it, could cause TNF to incur significant

legal expenses and divert TNF’s management’s attention from the operation of its business.

Prohibitions or restrictions on

sales or withdrawal of future products marketed by TNF could materially affect its business in an adverse way.

in regulations, statutes or the interpretation of existing regulations could impact TNF’s business in the future by requiring,

(i) changes to TNF’s manufacturing arrangements;

(ii) additions or modifications to product labeling;

(iii) the recall

or discontinuation of TNF’s products;

or (iv) additional record-keeping requirements.

If any such changes were to be implemented, they

could adversely affect the operation of TNF’s business.

Reimbursement

of any of TNF’s product candidates that are approved for marketing in the United States or any other products TNF may commercialize

in the future, as applicable, will depend, in part, on the extent to which TNF’s products, if approved, will be covered by third-party

payors, such as government health programs, commercial insurers, and managed healthcare organizations, as well as the level of reimbursement

that those third-party payors provide for TNF’s products.

Patients and providers are unlikely to use TNF’s products unless

coverage is provided and reimbursement is adequate to cover a significant portion of the cost of TNF’s products.

In the U.S., no

uniform policy of coverage and reimbursement for drugs or biological products exists, and one payor’s determination to provide

coverage and adequate reimbursement for a product does not assure that other payors will make a similar determination.

Accordingly, decisions

regarding the extent of coverage and amount of reimbursement to be provided for any of TNF’s product candidates, if approved, will

be made on a payor-by-payor basis.

As a result, the coverage determination process may be a time-consuming and costly process that will

require TNF to provide scientific and clinical support for the use of TNF’s products to each payor separately, with no assurance

that coverage and adequate reimbursement will be obtained.

Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into and have in effect a national rebate agreement with

the Secretary of the HHS as a condition for states to receive federal matching funds for the manufacturer’s outpatient drugs furnished

to Medicaid patients.

The ACA made several changes to the Medicaid Drug Rebate Program, including increasing pharmaceutical manufacturers’

rebate liability by raising the minimum basic Medicaid rebate on most branded prescription drugs and adding a new rebate calculation

for “line extensions” (i.e., new formulations, such as extended release formulations) of solid oral dosage forms of branded

products, creating a new method by which rebates owed by pharmaceutical manufacturers are calculated for drugs that are inhaled, infused,

instilled, implanted or injected, as well as potentially impacting their rebate liability by modifying the statutory definition of average

manufacturer’s price (“AMP”).

The ACA also expanded the universe of Medicaid utilization subject to drug rebates by

requiring pharmaceutical manufacturers to pay rebates on Medicaid managed care utilization and by enlarging the population potentially

eligible for Medicaid drug benefits.

Pricing and rebate programs must also comply with the Medicaid rebate requirements of the U.S.

Budget Reconciliation Act of 1990.

Medicare Prescription Drug Improvement and Modernization Act of 2003 (“MMA”) established the Medicare Part D program to provide

a voluntary prescription drug benefit to Medicare beneficiaries.

Under Part D, Medicare beneficiaries may enroll in prescription drug

plans offered by private entities that provide coverage of outpatient prescription drugs.

Unlike Medicare Part A and B, Part D coverage

is not standardized.

While all Medicare drug plans must give at least a standard level of coverage set by Medicare, Part D prescription

drug plan sponsors are not required to pay for all covered Part D drugs, and each drug plan can develop its own drug formulary that identifies

which drugs it will cover and at what tier or level.

However, Part D prescription drug formularies must include drugs within each therapeutic

category and class of covered Part D drugs, though not necessarily all the drugs in each category or class.

Any formulary used by a Part

D prescription drug plan must be developed and reviewed by a pharmacy and therapeutic committee.

Government payment for some of the costs

of prescription drugs may increase demand for products for which TNF receives marketing approval.

However, any negotiated prices for

TNF’s products covered by a Part D prescription drug plan likely will be lower than the prices TNF might otherwise obtain.

while the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment

limitations in setting their own payment rates.

Any reduction in payment that results from the MMA may result in a similar reduction

in payments from non-governmental payors.

a drug product to receive federal reimbursement under the Medicaid or Medicare Part B programs or to be sold directly to U.S.

agencies, the manufacturer must extend discounts to entities eligible to participate in the 340B drug pricing program.

The required 340B

discount on a given product is calculated based on the AMP and Medicaid rebate amounts reported by the manufacturer.

As of 2010, the

ACA expanded the types of entities eligible to receive discounted 340B pricing, although, under the current state of the law, with the

exception of children’s hospitals, these newly eligible entities will not be eligible to receive discounted 340B pricing on orphan

In addition, as 340B drug pricing is determined based on AMP and Medicaid rebate data, the revisions to the Medicaid rebate formula

and AMP definition described above could cause the required 340B discount to increase.

The 340B program imposes ceilings on prices that

drug manufacturers can charge for medications sold to certain health care facilities.

It is unclear how this decision could affect covered

hospitals who might purchase TNF’s products in the future and affect the rates TNF may charge such facilities for its approved

In addition, legislation may be introduced that, if passed, would further expand the 340B program to additional covered entities

or would require participating manufacturers to agree to provide 340B discounted pricing on drugs used in an inpatient setting.

noted above, the marketability of any products for which TNF receives regulatory approval for commercial sale may suffer if the government

and other third-party payors fail to provide adequate coverage and reimbursement.

An increasing emphasis on cost containment measures

has increased and TNF expects it will continue to increase the pressure on pharmaceutical pricing.

Coverage policies and

third-party reimbursement rates may change at any time.

Even if favorable coverage and reimbursement status is attained for one or more

products for which TNF receives regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the

laws, and future state and federal healthcare reform measures may be adopted in the future, any of which may result in additional reductions

in Medicare and other healthcare funding and otherwise affect the prices TNF may obtain for any of its product candidates for which TNF

may obtain regulatory approval or the frequency with which any such product candidate is prescribed or used.

addition, in most foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed.

The requirements

governing drug pricing and reimbursement vary widely from country to country.

For example, the EU provides options for its Member States

to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the

prices of medicinal products for human use.

Reference pricing used by various EU Member States and parallel distribution, or arbitrage

between low-priced and high-priced Member States, can further reduce prices.

A Member State may approve a specific price for the medicinal

product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product

on the market.

In some countries, TNF may be required to conduct a clinical study or other studies that compare the cost-effectiveness

of any of TNF’s product candidates to other available therapies in order to obtain or maintain reimbursement or pricing approval.

There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will allow

favorable reimbursement and pricing arrangements for any of TNF’s products.

Historically, products launched in the EU do not follow

price structures of the U.S.

and, generally, prices tend to be significantly lower.

Publication of discounts by third-party payors or

authorities may lead to further pressure on the prices or reimbursement levels within the country of publication and other countries.

of December 31, 2024, TNF had two full-time employees and no part-time employees.

TNF has not experienced any work stoppages.

TNF’s employees are represented by a labor union or covered by collective bargaining agreements, and TNF considers its relationship

with its employees to be good.

Clinical Studies

In October 2020 we completed several

in vitro studies from human primary cell-based BioMap systems at Eurofins contrasting Isomyosamine with Humira, Enbrel and Remicade.

November 2022, the company published data from the Phase 1 dosing study for Isomyosamine as a treatment for aging.

There was a statistically

significant decrease in TNF-α levels (p-value <0.05) found in one Isomyosamine treated cohort, but no change in the levels in subjects

given placebo.

TNF is preparing a Phase 2 study protocol, “Double blind placebo-controlled

parallel group study of safety and efficacy of Isomyosamine in treating sarcopenia after hip or femoral fracture in gerontological population”

for submission to the FDA.

This study will expand upon the prior 28-day dosing study and will evaluate functional improvements in subjects

after Isomyosamine dosing of up to 90 days.

phase II study for rheumatoid arthritis, “A double-blind, randomized, placebo-controlled multicenter Phase II proof-of-concept

study to evaluate the efficacy, safety, biological activity, and pharmacokinetics of MYMD-1™ added to methotrexate in patients

with moderate-to-severe active rheumatoid arthritis” IND application was reviewed and approved by the FDA to begin clinical trials

on August 9, 2023.

October 2020 we completed several in vitro studies from human primary cell-based BioMap systems at Eurofins contrasting Isomyosamine

with Humira, Enbrel and Remicade.

for Autoimmune Diseases

Dog Study – completed on December 20, 2021:

A 39-Week Toxicity and Toxicokinetic Study of Isomyosamine by Oral Gavage in Beagle Dogs.

Rat Study – completed on December 17, 2021:

A 26-Week Toxicity and Toxicokinetic Study of Isomyosamine by Oral Gavage in Rats.

Mouse Study – Completed May 2020 with results pending:

A Preliminary Introductory Traumatic Optic Neuropathy (TON) in a Mouse

produced guidance on dosing levels and overall safety in human studies.

in collaboration with Charles River Laboratories completed “A 90-Day Oral Gavage Electroencephalogram Safety Study of A Test

Item In The Beagle Dog”.

Dosing began on December 19, 2023, and ended around March 20, 2024.

All animals completed the study

and there was no treatment related adverse events reported.

A final study report was provided to FDA in December 2024.

Palmer in collaboration with TNF completed a study “TNF in Traumatic Optic Neuropathy (TON) in a Rat Pilot Study Vehicle versus

The crush injury raised levels of TNF-α.

After being dosed with Isomyosamine, TNF-α levels were brought down

in crush injury compared to controls, but the decrease did not meet statistical significance (p=0.095).

Likely cause of the result

not reaching p<0.05 may be attributed to rebound (e.g.

TNF-α levels would have gone up when Isomyosamine stopped;

may need to me adjusted.

The initial data was promising and will guide a longer study in the future.

scientific journal article on Isomyosamine was published in The Journals of Gerontology in August 2022.

This manuscript supports our continued

efforts to conduct a second Phase 2 Trial for Rheumatoid Arthritis, which was approved for clinical trials in August 2023, and additional

autoimmune diseases that we may pursue.

Additionally, “MYMD-1 Improves Health Span and Prolongs Life Span in Old Mice:

A Noninferiority

Study to Rapamycin” by Johns Hopkins Medical School.

This journal article details a 12-month mouse trial studying aging and longevity

with Isomyosamine.

We also completed several in vitro studies from human primary cell-based BioMap systems at Eurofins contrasting Isomyosamine versus

Rapamycin further supporting our transition to Rheumatoid Arthritis.

November 2022, TNF published “A Double-blind, Placebo-controlled, Randomized, Single Ascending, and Multiple Dose Phase 1 Study

to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral Dose Isomyosamine Capsules in Healthy Adult Subjects” Authors:

Jenna Brager, Chris Chapman, Leonard Dunn, and Adam Kaplin in Drug Research.

This became available in print on February 28, 2023.

journal article details the results from the Phase 1 clinical trial.

An abstract was accepted for presentation at the British Society of Immunology, Liverpool, UK in December 2022.

“Pharmacology and

clinical profile of MYMD-1 ® , an oral, selective, next-generation, TNF- α inhibitor that crosses the

blood brain barrier” authored by Jenna Brager, Ronald Christopher, Adam Kaplin, and Chris Chapman.

In 2023, an abstract was accepted for presentation at the Society of Toxicology to be presented in March 2023, entitled, “A

Naturally Occurring Novel Therapeutic and Oral Selective Inhibitor of TNFa, MYMD-1, Significantly Reduced the Inflammation

and Disease Severity in Murine Model of Collagen Antibody-Induced Arthritis” authored by Chris Chapman and Sonia Edaye.

with its partner Frontage Laboratories plans to submit an abstract to the 39 th Japanese Society for the Study of Xenobiotics

(JSSX) and 26 th North American Meeting of International Society for the Study of Xenobiotics (ISSX) in Honolulu, Hawaii;

Identification of the Major Circulating Norcotinine and Elucidation of the Mechanism of Clearance of MYMD-1 in Humans.

of Aldehyde Oxidase and CYP2A6.

On December 7, 2024, TNF presented

at The Society on Sarcopenia, Cachexia, & Wasting Disorders (SCWD) 17 th International Conference in Washington, D.C.

of the presentation was, “Isomyosamine for the Treatment of Sarcopenia in Elderly Population.”

publications and abstracts support the continued development of Isomyosamine ® across various indications.

for Hashimoto’s Thyroiditis

February 18, 2022, we submitted an Annual Report to the FDA for the previously opened Hashimoto’s Thyroiditis IND.

Annual Report was submitted to the FDA on November 22.

April 2021, the FDA gave clearance for a Phase 1 dosing study in normal healthy volunteers;

Institutional Review Board (IRB) approval

was obtained on April 4, 2021.

The clinical trial was conducted by The Clinical Research of West Florida Phase 1 unit with a closeout

visit taking place on November 22, 2021.

of laboratory parameters, vital sign, ECG, and physical findings did not reveal any clinically relevant effect of Isomyosamine.

dose group, there was a decrease in TNF-α levels found in Isomyosamine treated subjects, but no change in the levels in subjects

given placebo.

In one dose group, there was a decrease in TNF-α levels found in Isomyosamine treated subjects, but no change in the

levels in subjects given placebo.

data from the Phase 1 clinical trial was submitted to the FDA on September 14, 2021 as part of the Annual IND update for Hashimoto’s

Thyroiditis IND.

The FDA responded by providing guidance on moving forward with Phase 2 clinical trials.

data was also included in a new commercial IND to the FDA on September 22, 2021.

Company completed CYP in vitro studies which concluded that clinical drug-drug interactions are not expected with Isomyosamine.

CYP induction

is the most commonly studied form of induction in drug metabolism and is required by regulatory authorities.

had Isomyosamine synthesized in August 2021 to [14C] Isomyosamine radiolabeled product for Mass Balance, Pharmacokinetic, and Metabolism.

of the rat study results demonstrated that Isomyosamine was metabolized extensively throughout the tissues, crosses the blood brain barrier,

was cleared in the urine and feces, and there were no nitrosated metabolite biological samples detected.

Metabolite Identification

and Quantitation of Isomyosamine in Rat, Dog, and Human Plasma Samples:

Metabolites in Safety Testing (MIST) was completed in October 2022.

Isomyosamine was extensively metabolized and was detected at low levels (<5%) in human plasma.

November 2022, the Company published data from the Phase 1 dosing study for Isomyosamine as a treatment for aging.

August 5, 2021, our lead product candidate Isomyosamine was shown to suppress cytokines, which are the major cause of death in COVID-19

patients, in a human cell study.

TNF may also seek additional FDA guidance on depression in MS patients under an Orphan Drug Designation

On October 3, 2023, Charles River

Laboratories provided a final report titled, “A Dose Range-Finding Embryo-fetal Development Study of MYMD-1 by Oral (Gavage) in

Rats.” The results of this study found that there were no drug-related fetal malformations or variations at any of the evaluated

We have an active IND to start

a Phase 2 study for the indication Hashimoto’s Thyroiditis.

manufacturing, we will continue to provide GMP Isomyosamine capsules for Phase 2 clinical trials.

We plan to continue analytical analysis to

provide GMP product other that capsules for long-term human trials.

have received domestic patent protection for Isomyosamine, including its use in methods of extending lifespan and treating arthritis, autoimmune

diseases, and inflammatory and age-related disorders including sarcopenia.

We will continue to prosecute patents to protect intellectual

property for Isomyosamine in the United States and abroad.

Patent Issued March 26, 2024:

US Application 17/851,862:

Method of Treating Diseases

of the Visual System.

Product Candidate

from Eurofins studies involving human primary cell-based BioMap system demonstrated that Supera-CBD delivers an extremely potent therapeutic

benefit of 8,000 times that of plant-derived CBD at activating CB2 receptors, permitting its delivery at a very low non-toxic dose.

August 10, 2021, the Company was awarded U.S.

Patent 11,085,047 B2, titled “Synthetic Cannabinoid Compounds for Treatment of Substance

Addiction and Other Disorders,” covering the Super-CBD product candidate and its pharmaceutical formulations.

During 2021 and 2022

corresponding foreign patents were awarded in Australia, Canada, Europe, Israel, and South Korea, and patents are pending in China and

Hopkins Medicine researchers presented Supera-CBD data at the 3 rd Annual Neuroimmunology Drug Development Summit on April

Company presented data referencing Super-CBD at the 4 th Annual International Cannabinoid Summit on September 9, 2021.

March 2, 2023, we announced that the U.S.

Drug Enforcement Administration (DEA) has conducted a scientific review and determined

that it would not list Supera-CBD as a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its

governing regulations.

We believe that this decision will expedite future research involving Supera-CBD by relieving us or our

research partners from having to comply with regulations relating to controlled substances.

plan to continue our preclinical program starting genotoxicity studies in Europe.

Those studies include:

profiling and Ames test (initiation December 21, 2021;

completion January 20, 2022);

test (initiation December 21, 2021;

completion February 20, 2022).

manufacturing, we expect to continue providing GMP Supera-CBD materials for the preclinical toxicity programs.

We plan to continue analytical

analysis to provide GMP materials for long term toxicity and Human trials.

example of our continued efforts include:

the JHM Research, which is conducting a study with Isomyosamine and L/R-Supera-CBD

for Depression and Anxiety;

Plus Maze and Fear Conditioning;

response study;

open field and Y maze study;

LPS induced depression.

Plans for 2025

plans to launch a Phase 2b clinical trial of isomyosamine’s efficacy in sarcopenia early in the first quarter of 2025.

will further explore the drug’s efficacy in sarcopenia/frailty following statistically significant positive results from an earlier

Phase 2 clinical study.

October 19 2024, the Company announced that it has entered into a collaborative agreement with Renova Health for a planned trial of its

TNF-alpha (TNF-α) inhibitor drug Isomyosamine as a treatment for GLP-1-induced sarcopenia and frailty.

The fully funded study is

expected to evaluate TNF-α levels in patients receiving GLP-1 agonist Wegovy or Ozempic who show signals for increased inflammation

associated with sarcopenia.

website address is www.tnfpharma.com .

application, 69 issued foreign patents, and 5 foreign patent applications pending in such jurisdictions as Canada, China, Israel,

and Japan which, if issued, are expected to expire between 2036 and 2041.

Company’s ability to protect and enforce its intellectual property rights is important to its competitive position.

However, there

can be no assurance that these protections will be adequate.

Company operates in industries that are subject to extensive and evolving regulatory requirements.

Company faces multi-layered hurdles at the intersection of crypto, hardware and emerging quantum technology.

The Company’s

hardware may also be subject to export controls under the International Traffic in Arms Regulations (ITAR) and Export Administration

Regulations (EAR), as well as Federal Communications Commission (“FCC”) and Underwriters Laboratories (“UL”)

certifications for energy-efficient devices.

Additional regulatory risks include evolving SEC and Commodity Futures Trading

Commission (CFTC) guidance on DePin Tokens and cryptocurrency energy usage, and compliance with the European Union’s Markets

in Crypto-Assets Regulation (MiCA).

Post-quantum cryptography standards, cybersecurity risks, and potential intellectual property

enforcement challenges under the LightSolver license agreement may also impact operations.

The Company’s pharmaceutical product candidates are subject to extensive

regulation by the U.S.

Food and Drug Administration (“FDA”) and other regulatory authorities in the United States and abroad.

Before a new drug can be marketed, the Company must complete pre-clinical studies, file an investigational new drug application (“IND”),

conduct adequate and well-controlled clinical trials, and submit a new drug application (“NDA”) for FDA approval.

is also subject to healthcare laws and regulations, including the Anti-Kickback Statute, the False Claims Act, the Health Insurance Portability

and Accountability Act of 1996 (“HIPAA”), the Physician Payments Sunshine Act, and various state and foreign fraud and abuse

The biotechnology and biopharmaceutical industries are characterized by rapid evolution of technologies, fierce competition, and

vigorous defense of intellectual property.

These regulations govern the pre-clinical, clinical, and post-marketing requirements applicable

to pharmaceutical product development, including IND submissions and related regulatory filings and compliance obligations.

can be no assurance that the Company will be able to comply with all applicable regulatory requirements or that regulatory developments

will not adversely affect its business.

of December 31, 2025, the Company had two full-time employees and no part-time employees.

The Company has not experienced any work stoppages.

None of the Company’s employees are represented by a labor union or covered by collective bargaining agreements, and the Company

considers its relationship with its employees to be good.

website address is www.qctechnologies.com .

We do not intend our website address to be an active link or to otherwise incorporate by

3 unchanged sentences

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What changed 10-K

Item 1. Business