What changed in this filing

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Item 1. Business

2026-03-31 compared with 2025-03-26 · 377 added, 916 removed, 271 unchanged (83% of the section changed)

is a clinical-stage biotechnology company developing therapeutic candidates in inflammatory and immunologic conditions with high unmet

On November 3, 2023, we entered into a patent license agreement (the “Avior Patent License Agreement”) with Avior,

d/b/a Avior Bio, LLC (“Avior”) pursuant to which we received an exclusive sublicensable right and license to Licensed

Patent Rights and Licensed Technology to, among other things, Develop, have Developed, make, have made, use, sell, import, export and

commercialize TH104 and TH103 and to practice the Licensed Technology in connection with the foregoing, throughout the world, each as

defined in the Avior Patent License Agreement.

In February 2023, the U.S.

Food and Drug Administration (“FDA”) approved an

investigational new drug (“IND”) application for TH104.

is a proprietary transmucosal buccal film embedded with the active compound nalmefene onto a thin film which easily adheres inside of

the mouth on the cheek and biodegrades within minutes.

This provides key features making TH104 an ideal product candidate for multiple

liver-related and other pruritogenic inflammatory conditions.

The molecule has a dual mechanism of action affecting both the µ-opioid

and kappa opioid receptors.

These well-known opioid receptors when stimulated and/or inhibited by the body’s endogenous ligands

have been shown to be involved in the body’s itch circuitry for certain conditions, including cholestatic or dysregulated bile

acid-related liver conditions.

has a dual mechanism of action by affecting multiple receptors, known to suppress chronic, debilitating pruritus or “uncontrollable

itching” With respect to TH104, we intend to first seek approval for the treatment of moderate-to-severe chronic pruritus in patients

with primary biliary cholangitis (“PBC”), an orphan rare form of liver disease with no known cure in which more than 70%

of patients suffer from debilitating chronic pruritus.

A Phase 2 proof-of-concept (“POC”) trial with TH104

is ready to be initiated and the Company intends to conduct a hepatic impairment trial prior and expects to develop TH103 and potentially file an IND at some point in the future, depending on discussions with the FDA.

TH104, administered via a

transmucosal buccal delivery system applied to the inside of the mouth by adhering to the cheek, is anticipated to demonstrate a favorable

safety profile in a dedicated hepatic impairment study.

This expectation is supported by data from nalmefene tablets (Selincro ® ),

a product available in Europe and not in the United States with relevant pharmacokinetic considerations.

Selincro studies, using a single

18.06 mg dose, revealed that patients with mild hepatic impairment experienced a 1.5-fold increase in exposure (AUC) and a 35% decrease

in oral clearance compared to healthy subjects.

In patients with moderate hepatic impairment, the impact was even more pronounced:

(AUC) increased 2.9-fold, Cmax increased 1.7-fold, and oral clearance was reduced by approximately 60%.

Critically, despite these significant

changes in exposure and clearance, no clinically relevant alterations were observed in either Cmax or the elimination half-life in either

the mild or moderate hepatic impairment groups.

This data provides a potential foundation for predicting TH104 behavior and we intend

to acknowledge that pharmacokinetic data for nalmefene in patients with severe hepatic impairment is not yet available, and that there

are existing contraindications and precautions.

Therefore, while the nalmefene data suggests a reduced risk profile for TH104, we planto

begin a hepatic impairment study in 2025 to fully evaluate the pharmacokinetic profile and safety in certain stages of liver impairment,

beginning with mild and moderate, and potentially severe impairment prior to launching the phase 2 study to ensure we have potential suitable

precautions in place if necessary.

September 11, 2024, we entered into a Patent License Agreement (the “Intract Agreement”) with Intract Pharma Limited (“Intract”),

pursuant to which, we exclusively licensed INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha (TNF-a) monoclonal antibody infliximab.

Infliximab is a purified recombinant DNA-derived chimeric IgG monocloncal antibody protein that contains both murine and human components

that inhibit tumor TNF-a.

Under the terms of the Intract Agreement, we licensed global development and commercialization rights (outside

of South Korea) to Intract’s Soteria® and Phloral® delivery platform along with an existing supply agreement for infliximab

to be used in the oral product development program.

are also developing an early-stage pipeline of novel therapeutic candidates targeting validated high value immuno-oncology (“IO”)

targets including human epidermal growth factor (“EGF”) receptor 2 (“HER2”), human EGF receptor 3 (“HER3”)

and programmed cell death protein (“PD-1”) and vascular endothelial growth factor (“VEGF”).

We are developing

antibodies including bispecific antibodies, antibody drug conjugates (“ADCs”) and small molecular weight bovine- derived

“knob” domains which have the potential to target and bind more tightly to “undruggable” epitopes with conceivably

improved characteristics compared to full sized antibodies.

We are developing HS1940, a novel multispecific biologic targeting both

PD-1 and VEGF.

We are advancing HS3215, a bispecific against both HER2 and HER3 antibody which targets a novel “bridging epitope”

encompassing multiple domains of the HER2 extracellular domain (“ECD”) as well as ligand-dependent and independent blocking

of the ECD of HER3.

is an immunosuppressive checkpoint and seen in macrophages, B lymphocytes, dendritic cells, monocytes, tumor-specific activated T cells,

myeloid cells and natural killer cells in circumstances of chronic antigen contact.

PD-L1 is one of the PD-1 ligands.

PD-L1 expression

has been shown to be a valuable biomarker for the prognosis and prediction of the sensitivity of PD-1/PD-L1 inhibitors.

The expression

of PD-L1 is mainly expressed in tumor cells, tumor-infiltrating cells and antigen-presenting cells in many cancers.

Despite the noteworthy

efficacy of PD-1/PD-L1 immune checkpoint inhibitors (“ICI”) in the treatment of tumors, some problems remain such as drug

resistance and adverse events.

Acquired drug resistance may present despite resuming or continuing treatment with anti-PD-1/PD-L1 immunotherapy.

The presence of drug resistance significantly reduces the efficacy of anti-PD-1/PD-L1 immunotherapy.

We believe exploring the mechanisms

of PD-1/PD-L1 ICI resistance may assist with the discovery of new immunotherapeutic strategies to control disease progression and provide

a more sustainable survival benefit for patients.

As such, we aim to further improve on PD-1 as a breakthrough technology by developing,

HS1940, a proprietary PD-1 Picobody with unique binding affinity differently than currently available PD-1 drugs.

We believe this unique

binding difference allows for novel therapeutic possibilities both as a stand-alone agent and in combination and that our tumor immunotherapy

based on PD-1 inhibition may become a future strategy for human cancers.

EGF subset known as the epidermal growth factor receptor (“ErbB”) family of receptors are a validated set of targets preferentially

overexpressed on certain solid tumors which can be clinically exploited for the treatment of drug resistant cancers.

The ErbB family

is encompassed of four members that belong to the transmembrane tyrosine kinase receptors (“TKR”), including EGFR (“HER1”),

HER2, HER3 and HER4.

The most well-known member, HER2, encodes a transmembrane TKR which is comprised of three domains:

an ECD, a transmembrane

domain and an intracellular tyrosine kinase domain.

Ligand binding results in heterodimerization or homodimerization between the ErbB

receptors leading to excitation of the intracellular tyrosine kinase domain which then activates downstream signaling pathways concerning

cellular proliferation, differentiation, migration and apoptosis.

is an orphan receptor lacking a unique endogenous ligand and preserves an active conformation, making it continuously available to dimerize

and preferred as a partner for neighboring member receptors.

Juxtaposed to this distinct HER2 characterization, HER3 has several ligands

yet it lacks intrinsic tyrosine kinase activity.

HER2-HER3 pairing exhibits a favorable and more potent signaling, suggesting a corresponding action between both receptors.

is a known oncogene recognized in numerous cancer types and dysregulation of HER2 signaling can be caused by mutation, amplification

and overexpression.

Numerous cancers exhibit high levels of HER2 compared to normal tissue, specifically tumors of the breast, colorectal,

bladder, gastric, esophageal, endometrial, and ovarian cancers, signifying that HER2 may be connected to the progression of these tumors.

Additionally, following the discovery of HER2 in breast cancer, antibody drugs targeting HER2 were introduced into the clinic.

(trastuzumab), the first monoclonal antibody developed by Genentech/Roche was approved for the treatment of HER2-positive metastatic

breast cancer in 1998.

Subsequently, tyrosine kinase inhibitors (“TKIs”) and ADCs targeting HER2 have been approved.

antibody, PERJETA® (pertuzumab) also developed by Genentech/Roche, used in combination with trastuzumab, and docetaxel was approved

in 2012, indicated for the treatment of patients with HER2-positive metastatic breast cancer.

The FDA subsequently also approved a third

biologic from Genentech/Roche in 2013, KADCYLA® (trastuzumab emtansine or T-DM1), for the treatment of patients with HER2-positive

metastatic breast cancer in patients previously treated with trastuzumab and a taxane.

T-DM1 not only retains the target-selective benefit

of trastuzumab, but also kills tumor cells by delivering a potent toxin which inhibits microtubule function and has become a classic

example of a targeted ADC treatment.

Another ADC, ENHERTU® (trastuzumab deruxtecan), developed by Daiichi Sankyo and AstraZeneca

and approved in December 2019 for the treatment of unresectable or metastatic HER2-positive breast cancer has shown anti-tumor activity

in HER2-positive cancers that were resistant or insensitive to T-DM1.

We believe this development history of multiple approved drugs

with different modalities and novel epitopes targeting HER2 has paved a de- risked regulatory pathway as well left significant room for

continued innovation in this class of therapies.

According to the Fierce Pharma, in 2022, Roche/Genentech had worldwide sales of over

$8 billion with respect to their HER2 targeted therapies (Herceptin and Perjeta) as well as more than $500 million in worldwide sales

of ENHERTU® in the first half of 2023 alone according to AstraZeneca.

function of HER3 in tumor biology is multidimensional.

Abundant HER3 expression is identified in various solid tumor types, with a proven

role in disease progression.

Overexpression of HER3 signaling is thought to be involved in resistance to other targeted therapies used

for treating several cancers, including anti-EGFR therapies gefitinib and cetuximab.

One of the many genomic changes known to be implicated

in acquired resistance to anti-EGFR TKIs in patients with EGFR-mutated advanced non-small-cell lung cancer is HER3 up-regulation promulgated

by osimertinib.

Therefore, blocking HER3/EGFR dimerization complex is thought to prevent or slow down both acquired and primary resistance

to EGFR inhibitors.

We believe combining anti-HER2 with an anti-HER3 strategy as a bispecific multifunctional agent without a toxin (HS3215)

as well as with a toxin (HS0059) could capitalize on some of the findings described in the literature to take advantage of precise tumor-killing

through two important targets with different mechanisms of action.

currently have an IND-approved transmucosal film product, TH104, a Phase 2 ready clinical candidate and an oral biologic as well as

two bispecific biologics in pre-clinical development.

The following table summarizes our development candidate pipeline:

goal is to become a leading biotechnology company developing novel treatments in inflammatory and immunologic conditions with high unmet

Our business strategy comprises the following components:

Develop TH104 as a transmucosal buccal film product for the treatment

of chronic pruritus in PBC and other inflammatory diseases.

Develop TH023 by optimizing the CMC pathway and planning

a Phase 1 first-in-human clinical trial through feedback from a non-US regulatory authority

Create a preclinical and clinical path forward for our early stage product candidate, HS1940, a novel PD-1/VEGF with binding differentiation compared to full length antibodies for IO vulnerable tumors.

Hasten the discovery and development of next generation multi-specific (bi- and tri) antibodies with binding capabilities to novel epitopes of combinations of HER2, HER3, PD-1 and other validated targets with and without toxin delivery capacity to multiple high unmet need rare cancers.

Pursue strategic collaboration opportunities to maximize the value of our

pipeline to bring novel therapies to patients suffering from high unmet need conditions.

and moderate-to-severe chronic pruritus

to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, PBC, is a

chronic disease in where the bile ducts in the liver eventually become dysfunctional and cause the buildup of bile which causes liver

The disease, believed to be an autoimmune condition, affects both men and women with a rate higher in women, estimated at 1 out

of every 1,000 women over 40.

Pruritus is one of the most common conditions associated with PBC affecting up to 75% of individuals at

some point during their disease course.

It has a negative impact on health-related quality of life with limited treatment options.

an on-line survey focusing on certain features of patients’ itch respondents described their itch as “bugs crawling”

as well as more than 65% of participants reporting that the itch was worse at night, known as nocturnal pruritus.

Ladder for Pruritus in Primary Biliary Cholangitis

Hegade VS, Bolier R, Oude Elferink RPJ, et.

Frontline Gastroenterology 2016;7:158–166

endobiliary nasal drainage;

MARS, molecular adsorbent recirculating system;

LT, liver transplantation

current treatment ladder in pruritus for PBC shown above is the paradigm of therapy and if there is no response with one category of

drugs, typically patients “move up” the ladder.

A patient may need a combination of treatments to achieve and/or maintain

symptom remission.

opioid peptides are commonly believed to play a role in the modulation of cholestatic itch.

In the late 1980s, data documented that nalmefene

induced opiate-like withdrawal symptoms in individuals with cholestasis.

Following this, research noted heightened levels of Met-enkephalin

in the plasma of cholestatic patients.

In animal experiments, the activation of μ-opioid receptors by agonists induced scratching

behavior, while κ-opioid receptor agonists, on the contrary, reduced the sensation of itch.

Kim BS, Inan S, Ständer S, Sciascia T,Szepietowski JC, Yosipovitch G.

Role of kappa-opioid and mu-opioid receptors in pruritus:

Peripheral and central itchcircuits.

Exp Dermatol.

are the first publicly traded company to leverage Canton Coin (“CC”) and support the Canton Network to advance institutional

blockchain adoption and the digitization of financial markets.

In addition to driving value through activities on the Canton Network,

we also operate clinical-stage biotech research and development programs.

2022 through late-2025, we primarily operated as a biotechnology company, developing therapeutic candidates in inflammatory and

immunologic conditions with high unmet need.

In November 2025, we undertook a strategic shift to prioritize disciplined digital

asset treasury management and investment in the digital asset ecosystem, specifically the Canton Network.

November 2025, we have strengthened our liquidity and expanded our access to capital through a public offering of common stock and private placements, and by establishing a shelf registration statement and our ATM Program (as defined below).

Digital Asset Treasury Strategy

believe that the configurable privacy enabled by the Canton Network’s blockchain technology is transforming the future of

global finance by connecting leading institutions on a single, secure, and interoperable blockchain.

With trillions of assets

represented on-chain and the support of major market participants, the Canton Network delivers real-world utility, privacy, and

atomic settlement.

CC plays a critical role as the utility token for transactions on the Canton Network, with a purposefully

designed tokenomics policy that seeks to drive transparency and align incentives across the ecosystem.

Our strategic digital asset

reserve of CC reflects our conviction in the potential of the Canton Network to drive efficiency, transparency, and resiliency in

global markets.

Canton digital asset treasury strategy is part of our broader approach to enhancing our platform with capital

efficiency, diversifying treasury management practices, and engaging with emerging financial technologies.

We intend to execute a diverse strategy with the following key elements:

Operations and Network Participation :

We operate as a Super Validator and intend to run

additional validator nodes on the Canton Network.

Through these activities, we expect to

earn recurring protocol-based validation rewards in CC and support network security, resiliency, and

● Application

Support and Strategic Investments :

We plan to build, sponsor, or invest in applications

and middleware that complement capital markets transactions conducted on the Canton Network.

These activities may include investments in technology providers, workflow solutions, and

financial products designed to drive network utilization and expand institutional adoption,

with the objective of increasing transaction activity and long-term network value.

Our focus is on projects and companies that are built on, or tightly integrated with the Canton Network.

● Collaboration

and Ecosystem Advancement :

We plan to collaborate with other Super Validators and other ecosystem participants, including

financial institutions, technology providers, and application developers.

We believe championing such broad-based participation will

enhance the use case for Canton Network infrastructure and workflows, including custody, asset issuance, settlement, collateral and

margin management, payments, and the integration of public and private market interfaces.

Raising and Treasury Expansion :

We may, from time to time, access the capital markets, including through our ATM program and

other offerings, with the objective of deploying a portion of the net proceeds toward additional CC acquisitions and Canton-related

ecosystem investments.

The Company may also evaluate alternative financing structures designed to increase its CC exposure

in a manner intended to be accretive to shareholders on a per-share basis, subject to market conditions and risk management

considerations.

Management - Locking, Lending, and Options :

We expect to deploy a portion of our CC holdings

into long term locking programs, where applicable, to align with Canton governance frameworks

and seek enhanced rewards.

We may also engage in CC lending and secured financing transactions

to generate additional yield and improve capital efficiency, and we may utilize CC linked

options and other derivative income strategies—such as selling options or hedging structures—to

manage risk and potentially enhance returns on our CC portfolio.

We are active participants in the Canton Foundation and a member of the Foundation

Through this role, we help shape the Canton Network’s governance framework,

tokenomics, and strategic roadmap, and we believe our participation aligns our long term

interests with those of the broader ecosystem and its institutional users.

and Risk Management :

Our board of directors retains broad discretion over investment, treasury, validator, and leverage policies

and may amend or modify the digital assets treasury strategy.

All CC acquisitions, validator operations, and treasury management activities

(including locking, lending, and options) are overseen by senior management and the Board.

The Company intends to maintain internal controls,

custody arrangements, risk limits, and compliance protocols designed to support the prudent execution of its strategy.

strategy is designed to supplement our capital allocation framework by integrating a forward-looking, technology-driven approach to treasury

Over time, participation in the Canton Network—through infrastructure operations, token management, and strategic ecosystem investments—may offer strategic advantages for product development and global expansion.

of Canton Network and Canton Coin

Network is a public, permissionless blockchain with privacy proven to work at institutional scale.

Unlike traditional public blockchains,

Canton operates as a “network of networks,” where independently governed applications interoperate securely through decentralized

public infrastructure called the Global Synchronizer.

view the following Canton Network developments as particularly relevant to our strategy:

for Institutional Privacy .

Canton’s protocol implements “proof-of-stakeholder” validation which, unlike traditional

proof-of-stake networks, ensures that only the parties to a transaction can see and validate it.

The Global Synchronizer uses Byzantine

Fault Tolerant consensus to time-order cross-application transactions, keep participants in sync and prevent conflicts.

replicate and broadcast all data globally;

it coordinates proofs between participants, ensuring everyone reaches the same outcome, while

always preserving privacy.

Scale and Institutional Adoption.

Major institutions, fintechs and a fast-growing builder community create applications on Canton

to transact and synchronize assets and data atomically, 24/7, with highly configurable privacy.

Today, applications running on Canton

enable cross-market settlement and asset mobility without compromising confidentiality and process more than $6 trillion in tokenized

real-world assets, including over $350 billion in daily U.S.

Treasury repo.

The Global Synchronizer is independently stewarded by the

neutral Canton Foundation, which facilitates open governance, covering protocol oversight and improvement proposals.

Differentiated

CC is the native utility token of the network, used to pay traffic fees for the Global Synchronizer, and to reward those

who contribute measurable utility to the ecosystem.

Every coin in circulation is earned through network participation only.

Such participation

includes application providers building high-utility apps, users driving activity, Validators, and infrastructure operators (Super Validators).

CC’s fair-launch and incentive alignment across the network anchors the token in real-world transactions and utility over speculation.

supply follows a declining issuance curve designed to reward early contributors while trending toward long-term sustainability.

issuance started high to bootstrap participation and app development, then halves periodically (with the next halving in the second

quarter of 2029) to balance inflation and burn.

The share of new CC issuances is now shifting from favoring Super Validators to

applications and Validators.

Unlike other networks, approximately two-thirds of total supply over the first 10 years is available as

rewards for application providers and Validators, with approximately one-third to Super Validators.

follows a burn-and-mint equilibrium model that ties supply to verified network activity rather than fixed inflation or pre-minted reserves.

It provides a dynamic balance between fixed, dollar-denominated fees and a floating CC market price against a known issuance curve.

are fixed in $ terms, with users paying a set $ / MB for transactions that use the Global Synchronizer.

The quantity of CC burned depends

on market price:

users pay for network fees by burning the $USD equivalent amount of CC at the on-chain conversion rate.

the price is too high relative to on-chain activity, mint exceeds burn (net inflation), creating downward pressure on price.

is too low relative to activity, burn exceeds mint (net deflation), creating upward pressure on price.

Over time, the system seeks an

equilibrium where long-run net supply change approaches zero.

Because equilibrium can occur at different price/activity combinations,

the ultimate total CC supply is not predetermined.

This mechanism ensures that Canton’s token economy remains sustainable, utility-aligned,

and structurally supported as adoption scales — unlike the fixed-inflation models of many other L1 networks.

of our CC Tokens

hold substantially all of our CC tokens in custody accounts with institutional-grade custodians that have demonstrated records of regulatory

compliance and information security.

As a result, the primary counterparty risk we are exposed to with respect to our CC tokens is performance

obligations under the various custody arrangements into which we have entered.

We custody our CC tokens across multiple custodians to

diversify our potential risk exposure to any one custodian.

carefully select the custodians that custody our CC tokens after undertaking a due diligence process.

We negotiate specific contractual

terms and conditions with our custodians that we believe will help establish, under existing law, that our property interest in the CC

tokens held by our custodians is not subject to the claims of the custodian’s creditors in the event the custodian enters bankruptcy,

receivership or similar insolvency proceedings.

All of our custodians are subject to regulatory regimes intended to protect customers

in the event that a custodian enters bankruptcy, receivership or similar insolvency proceedings.

Based on existing law and the terms

and conditions of our contractual arrangements with our custodians, we believe that the CC tokens held on our behalf by our custodians

would not be considered part of a custodian’s bankruptcy estate were one or more of our custodians to enter bankruptcy, receivership

or similar insolvency proceedings.

For a discussion of risks relating to the custody of our CC tokens, see “Item 1A.

Risk Factors—

Risks Related to Our CC Strategy and Holdings — We face risks relating to the custody of our CC tokens, including the loss or destruction

of private keys required to access our CC tokens and cyberattacks or other data loss relating to our CC tokens, including smart contract

related losses and vulnerabilities.”

Therapeutic Candidate Developments

our subsidiary Gravitas, we develop therapeutic candidates in immunology and inflammation with high unmet need.

Product Pipeline

(formerly TH104) is a proprietary buccal film formulation of nalmefene, a long-acting opioid antagonist, being developed for prophylactic

protection against synthetic opioid exposure in military and first responder populations.

GV104 is a buccal film containing 16 mg of

nalmefene, designed for rapid absorption through the oral mucosa.

The film is approximately the size of a dime, enabling discreet and

convenient administration without water or injection equipment.

Buccal delivery bypasses hepatic first-pass metabolism, resulting in

higher bioavailability compared to oral administration.

is a 6-methylene derivative of naltrexone with pharmacological properties that address the limitations of naloxone.

In a head-to-head

clinical study comparing intramuscular nalmefene to intramuscular and intranasal naloxone for reversal of fentanyl-induced respiratory

depression, nalmefene demonstrated a plasma half-life of 8 to 11 hours compared to 30 to 90 minutes for naloxone, and mu-opioid receptor

binding affinity approximately 3.6 to 5.4 times higher than naloxone.

3 In this study, nalmefene achieved faster onset, greater

magnitude, and longer duration of respiratory depression reversal, with 100% of subjects achieving respiratory recovery compared to 60-80%

for naloxone formulations.

are pursuing FDA approval through the 505(b)(2) regulatory pathway, which permits reliance on the FDA’s prior findings of safety

and effectiveness for REVEX (nalmefene hydrochloride injection), which was approved by the FDA in 1995 and determined by the FDA in November

2017 to not have been withdrawn from sale for reasons of safety or effectiveness.

5 Following a Type C meeting with the FDA

in March 2025, we confirmed that no additional clinical trials are required to support our NDA submission.

We anticipate initiating a

rolling NDA submission in the first half of 2027, with FDA approval anticipated in the first half of 2028.

(formerly TH023), is an oral anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, infliximab.

On September 11, 2024, we

entered into a Patent License Agreement (the “Intract Agreement”) with Intract Pharma Limited (“Intract”), pursuant

to which, we exclusively licensed GV023.

Infliximab is a purified recombinant DNA-derived chimeric IgG monoclonal antibody protein that

contains both murine and human components that inhibit tumor TNF-a.

Under the terms of the Intract Agreement, we licensed global development

and commercialization rights (outside of South Korea) to Intract’s Soteria® and Phloral® delivery platform along with an

existing supply agreement for infliximab to be used in the oral product development program.

Cipriano A, Apseloff G, Kapil RP, He E, Shet M, Harris SC.

Time Course of Reversal of Fentanyl-Induced Respiratory Depression in

Healthy Subjects by Intramuscular Nalmefene and Intramuscular and Intranasal Naloxone.

J Clin Pharmacol.

2025;65(2):206-216.

doi:10.1111/exd.14669

is a product which has been developed by embedding drug onto a proprietary transmucosal buccal film which adheres to the inside of the

TH104 has key features which we believe make it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory

The active molecule, nalmefene, has a dual mechanism of action by affecting both the µ-opioid receptor and the kappa

opioid receptor as well as inhibiting IL-17 inflammatory cytokine expression, a cytokine known to be overexpressed in PBC patient liver

tissue and serum.

Moniaga CS, et.

Plasma dynorphin A concentration reflects the degree of pruritus in CLD Acta Derm Venereol.

2019 Apr 1;99(4):442-443.

Wang DS, Sternbach G, Varon J.

A Long-Acting Opioid Antagonist.

Clinical Applications in Emergency Medicine.

1998;16(3):471-475.

Bergasa N et.

Oral nalmefene therapy reduces scratching activity due to the pruritus of cholestasis:

a controlled study J Am Acad Dermatol 1999;41:431-4

data by Bergasa et.

al , reported a study utilizing oral doses of nalmefene ranging from 40 to 240 mg twice-daily for 12 weeks

in PBC patients.

Eight patients who received at least 1 course of nalmefene were available for comparison with corresponding control

data (a course of placebo and/or at baseline).

Nalmefene therapy was associated with a 75% reduction in hourly scratching activity (P

The study also achieved a decrease in the mean of a visual analogue score of the perception of pruritus in all 8 patients

(mean decrease 77%, P < .01).

the itch circuitry is imbalanced in diseased conditions, pharmacological intervention can help suppress this phenomenon which occurs

in patients suffering from chronic pruritus.

Nalmefene crosses into the circulation via a proprietary buccal delivery by adhering the

drug-coated film inside the cheek where the film biodegrades in minutes and the drug is absorbed.

The buccal delivery of the drug bypasses

the liver’s first-pass metabolism thus creating high drug concentrations in the skin, an added benefit for treating conditions

in which the liver may be impaired.

data from multiple phase 1 ex-US trials achieved the primary objective of predictable pharmacokinetic profiling with favorable safety

and tolerability.

The first human phase 1 trial was a single-dose, single-center, open-label, randomized, 2-way crossover study of TH104

transmucosal buccal film compared to a tablet formulation marketed in Europe and not the United States, with a 14-day washout period

involving 12 normal healthy volunteers under fasting conditions.

The primary outcome measure was to determine the pharmacokinetics of

a buccal dose of TH104, while secondary objectives included establishing the relative bioavailability of TH104 and evaluating its’

tolerability for potential value in clinical efficacy studies.

These data were also consistent with the comprehensive pre-clinical data

package submitted to the FDA as an IND which was approved in February 2023, including pharmacokinetic profiling in beagle dog studies

confirming once-daily dosing, fast or rapid onset and high bioavailability when comparing TH104 to intravenous nalmefene.

this study, the pharmacokinetic evaluation of TH104 transmucosal film compared to an oral tablet marketed in Europe but not the United

States, given as an equal-labelled dose in normal healthy volunteers under fasting conditions, was consistent and similar in comparison

with results from the literature.

The C max and AUC 0-∞ of TH104 was observed to be higher than the tablet

product because of a possible reduced presystemic metabolism in the lower GI and liver, which is potentially advantageous for patients

with an impaired liver.

The half-life and T max was observed to be similar for both products.

There were no deaths, other serious

adverse events, or other significant adverse events reported during the entire study with events consistent with the safety profile of

the marketed tablet in the literature including mild dizziness, headache and somnolence, nausea and vomiting.

launched a phase 1 pharmacokinetic trial for TH104 in early 2024 and completed the study with a topline readout in 2Q24.

data package is strengthened by the phase 1 clinical trials previously conducted outside of the U.S., which showed reliable bioavailability

of the active ingredient in TH104 via transmucosal film technology in healthy volunteers.

Phase 1 trial was a single-dose, single-center, open-label, randomized 2-way crossover study comparing 16mg of TH104 with 1mg intravenous

nalmefene administered under fasting conditions, with a 7-day washout period between doses.

Twenty healthy subjects were enrolled to

complete both doses of the crossover design.

All 20 subjects completed TH104 buccal dosing, while 19 of 20 subjects also completed the

intravenous dosing.

The primary objective was to evaluate the absolute bioavailability of TH104, as well as to assess safety and tolerability.

from the study indicate that the primary endpoint of the absolute bioavailability (F) of TH104, or fraction (or percentage) of the administered

dose absorbed into the systemic circulation compared to an equivalent intravenous dose of nalmefene, was 0.459 (45.9%).

The median time

to maximum concentration (C max ) of TH104 was 2.0 hours, with rising concentrations beginning within minutes of dosing.

mean half-life (T 1/2 ) as measured in the blood of subjects was 14 hours after a single buccal administration of TH104, compared

to 9 hours for the 1mg intravenous dose of nalmefene.

data are consistent and within range of published findings of population PK data of nine Phase 1 studies of 243 subjects with extensive

blood sampling.

Furthermore, in the same analysis, receptor occupancy of oral dosing of nalmefene using a robust PK model

for nalmefene was developed where a single 20mg dose showed μ-opioid receptor occupancy was simulated to be within or above 60-90%

for up to 22-24 hours.

Company believes PK results from this Phase 1 trial show proportional kinetics consistent with published findings of oral and intravenous

formulations of nalmefene including F, C max , T 1/2 and potential receptor occupancy time, suggest TH104 could be

developed for once-daily dosing in a target population of moderate-to-severe chronic pruritus in PBC patients.

on the Phase 1 data, Type C meeting feedback from the U.S.

Food and Drug Administration (FDA) was received and reported by the

Company in June of 2024 for its planned Phase 2 clinical trial with TH104.

The feedback received as Type C feedback from the FDA

confirmed the Company’s plan to pursue a 505(b)(2) approval pathway for TH104, which permits inclusion of data from external

studies when the active ingredient is already approved in the United States.

The FDA also agreed that the nonclinical studies

submitted to the FDA in advance of the meeting appear sufficient to support the proposed Phase 2 clinical trial.

In addition, the

FDA provided feedback on study design and certain recommendations regarding PBC patient inclusion, the primary endpoint to assess

pruritus in these patients, and considerations for monitoring for adverse events in this patient population.

Based on this

interaction, we plan to conduct a hepatic impairment study in 2025 to fully evaluate the pharmacokinetic profile and safety in

certain stages of liver impairment, beginning with mild and moderate, and potentially severe impairment.

We also began some start up

activities for the Phase 2 trial with TH104 in moderate-to-severe chronic pruritus in PBC patients in early 2025 and have

incorporated feedback from the FDA into its clinical protocol.

The Company also received

positive feedback from a Scientific Advice meeting with the European Medicines Agency (EMA) that included guidance on the planned

Phase 2 trial to advance TH104.

The EMA interactions specifically focused on both the Phase 2 and Phase 3 clinical program of TH104.

Overall, the Agency noted that using Article 10(3), hybrid application, is acceptable and could enable referring to non-clinical and

some safety data from the approved products.

Regarding non-clinical information provided, the Agency endorsed the strategy presented

by the Company and noted that there is no need to conduct additional animal studies and considered human exposure to be adequate to

move forward.

The Agency found the design and main features of the proposed Phase 2 study overall acceptable with some comments

which were addressed by the Company subsequently.

The Agency also provided general guidance for the design of a future Phase 3

to the Centers for Disease control and Prevention Summary Health Statistics National Health Survey, more than 4 million patients suffer

from liver disease in the U.S.

and about 1.7 million suffer from pruritus, where PBC has the highest rate of prevalence.

We believe TH104

may also be used for treating chronic pruritogenic conditions associated with cholestatic liver disease as well as other liver related

and non-liver related diseases including fatty and alcoholic liver, non-alcoholic liver disease and certain types of hepatitis.

pruritus is significant in liver diseases (40% chronic pruritus;

1.7 million patients affected) as well as chronic kidney diseases (24%

chronic pruritus;

1.3 million patients affected), hemodialysis as well as atopic dermatitis (40% pruritus;

2.7 million patients affected).

we expect TH104 to be manufactured with a high speed of manufacturing with several features including very high content uniformity, prepared

using scalable manufacturing methods and appropriate cost-of-goods.

We intend to be able to create a highly reproducible product using

a small manufacturing footprint with few contract drug manufacturing organizations in the marketplace which may allow limited entrants.

on Antibodies

human antibodies play a crucial role in drug development as therapeutic agents.

Antibodies are large Y-shaped proteins produced by the

immune system to identify and neutralize extraneous elements such as bacteria, viruses, and additional pathogens.

Their capability to

target particular molecules with high specificity and affinity are valuable tools in pharmaceutical therapeutics.

For drug development,

much research has enabled the generation of full-length human antibodies targeting a variety of pathophysiological agents, anomalous

cells, or malfunctioning proteins associated in different diseases.

Using an array of methodologies, these antibodies can be developed

using different approaches, including phage display, hybridoma technology, and techniques involving novel antibody engineering focused

on structural diversity.

The realization of numerous therapeutic antibodies has considerably affected the treatment of diverse diseases,

including cancer, autoimmune disorders, infectious, and inflammatory conditions.

Their promising therapeutic properties, including decreased

toxicity and augmented specificity compared to small molecules and other modalities with off-target effects, make them appealing candidates

for human therapeutic development.

large number of traditional antibodies are composed of immunoglobin G (IgG) format in a Y-shape molecule consisting of two heavy chains

which are identical as well as two light chains also identical.

A heavy chain pairs with a light chain to form two variable regions,

or antibody binding fragment (Fab) which binds to antigens of the target.

The constant region includes a region referred to as the fragment

crystallizable (Fc) which binds to receptors present on cells in the immune system known as effector cells.

In traditional full length

monoclonal antibodies, the variable regions are identical and bind to the same target.

antibodies are a specialized class of therapeutic antibodies designed to concurrently target two dissimilar antigens.

Unlike traditional

monoclonal antibodies that bind to a single target, bispecific antibodies can employ multi-specific targeting, offering distinctive benefits

in drug development.

By targeting two separate molecules involved in a disease process, bispecific antibodies enhance therapeutic efficacy,

improve target specificity, and potentially overcome certain treatment resistance mechanisms.

The development of bispecific antibodies

involves different engineering strategies including quadroma technology, chemical conjugation-based methods and more recent technologies

including Dual Variable Domain Immunoglobulin and two-in-one models can be employed to generate bispecific antibodies.

These bispecific

agents can target a diversity of disease-related pathways, creating adaptable molecules for numerous medical ailments, including cancer.

Ongoing research and improvements over the last decade in antibody engineering allow for the design, optimization and scale-up of bispecific

antibodies for human therapeutics development.

Pipeline Candidates

is a product which has been developed by embedding drug onto a proprietary transmucosal buccal film which adheres to the inside of the

TH104 has key features which we believe make it an ideal product candidate for multiple liver-related and other pruritogenic inflammatory

The active molecule, nalmefene, has a dual mechanism of action by affecting both the µ-opioid receptor and the kappa

opioid receptor as well as inhibiting IL-17 inflammatory cytokine expression.

We intend to complete a phase 1 pharmacokinetic trial for

TH104 in second quarter 2024 as well as a phase 2 proof-of-concept in PBC patients over approximately 12 months after aligning with FDA

on trial design by late 2024/early 2025.

We believe TH104 may also be used for treating chronic pruritogenic conditions associated with

cholestatic liver disease as well as other liver related and non-liver related diseases including fatty and alcoholic liver, non-alcoholic

liver disease and certain types of hepatitis.

Chronic pruritus is significant in liver diseases as well as chronic kidney diseases, hemodialysis

and atopic dermatitis.

INT-023/TH023,

is an oral anti-tumor necrosis factor-alpha (TNF-α) monoclonal antibody, infliximab.

The product uses Intract Pharma’s Soteria ®

and Phloral ® delivery platform to deleiver infliximab as an oral product.

is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit

Tumor necrosis factor-alpha is a signaling protein involved in acute phase reactions and systemic inflammation.

is sold by Janssen Biotech under the Remicade ® brand for numerous indications including Crohn’s disease, ulcerative

colitis, rheumatoid diseases and plaque psoriasis.

Traditionally administered through intravenous infusions, oral delivery of antibodies

such as infliximab is challenging due to the complexity of navigating such large molecules through the gastrointestinal tract.

aims to overcome these challenges using Intract’s delivery platform, making it possible to administer infliximab in a pill form.

TH023 enables the targeted delivery of infliximab directly to the colon or small intestine and the Company intends to pursue the CMC

plan in 2025;

subsequent to adequate formulation development analyses the Company intends to begin planning a human phase 1 trial to

be conducted outside the United States as an initial proof-of-concept.

early-stage lead product candidate, HS1940, is a proprietary IO biologic, in development targeting PD-1 and VEGF.

On November 21, 2022,

we entered into a research collaboration and product license agreement with Minotaur and a commercial license agreement with Taurus for

use of certain technology, including OmniAb antibodies, to advance Picobodies against novel, unreachable and undruggable epitopes in

high-value validated targets starting with PD-1.

The research and collaboration agreement and product license agreement are for the development

of proprietary targeted biologics, including TH 1940, against PD-1 and VEGF.

It is anticipated that we will collaborate with Minotaur

under the license from Taurus to discover, develop and advance biotherapeutics against high-value validated IO targets starting with

We extended this agreement in July of 2023 with an additional target (HER3) and an oncology target.

are bovine-derived antibody “knob” domains comprised of cysteine-rich ultralong complementary determining region H3 sequences

of 30-40 amino acids weighing ~3-4 KDa, which have the potential to access challenging undruggable epitopes better than full size antibodies

By extending the half-life of knobs to create HS1940, we believe we can more efficiently target novel epitopes with greater binding

affinity than approved anti-PD-1 antibodies.

We further believe that the development of HS1940 is a step toward enabling us to enter

the rapidly growing IO market with additional targets thereafter.

Proceedings of the National Academy of Sciences of the United States of America “The smallest functional antibody fragment:

CDR H3 antibody knob regions potently neutralize SARS-CoV-2”

is an anti-HER2/HER3 bispecific antibody candidate.

The ErbB or HER family of cell surface proteins are some of the most well-known and

validated oncology drug targets including ErbB2 or HER2 and Erb3 or HER3.

Our antibodies against HER2 and HER3 bind to different domains

of the extracellular portion of the proteins or epitopes with trastuzumab primarily binding the ECD IV of HER2.

HER2 is a validated tumor

antigen for antibody drug conjugates to treat HER2 positive cancers with two approved antibodies, Roche/Genentech’s KADCYLA®

and Daiichi Sankyo/AstraZeneca’s ENHERTU®.

Areas of interest for the development of HS3215 are as a treatment of solid tumors

in which HER2 is overexpressed including breast cancer, colorectal cancer, endometrial cancer and gastroesophageal cancer.

ErbB family of receptor tyrosine kinases, also known as Human Epidermal Growth Factor Receptor (“HER”) family, comprises

four transmembrane receptors:

HER1 (EGFR/ErbB1), HER2 (Neu/ErbB2), HER3 (ErbB3), and HER4 (ErbB4).

These receptors play crucial roles

in the regulation of cell proliferation, survival, differentiation, and migration.

The ErbB family members are activated upon binding

to specific ligands, including EGF, transforming growth factor-alpha (TGF-α), amphiregulin (“AR”), and others, resulting

in receptor dimerization and autophosphorylation of specific tyrosine residues within their intracellular domains.

also known as EGFR, is the prototypical member of the ErbB family and is widely expressed in various tissues.

Its activation initiates

a downstream signaling cascade that involves the activation of the mitogen-activated protein kinase (“MAPK”) and phosphoinositide

3-kinase (“PI3K”)/AKT pathways, leading to cell proliferation and survival.

HER1 dysregulation has been implicated in various

cancers, making it an important therapeutic target.

also known as Neu or ErbB2, lacks a ligand-binding domain, and its activation is predominantly through heterodimerization with other

ErbB family members.

It is a key partner in heterodimerization with HER3, forming the most potent signaling complex among the ErbB receptors.

This heterodimerization is thought to cause an oncogenic signal into cells overexpressing these receptors and cause tumorigenesis.

is amplified and overexpressed in certain cancers, particularly breast cancer, contributing to aggressive tumor behavior and poor prognosis.

or ErbB3, possesses impaired tyrosine kinase activity, but its dimerization with other ErbB receptors, particularly HER2, leads to the

activation of downstream signaling pathways.

HER3 is a critical regulator of PI3K signaling, which is crucial for cell survival and proliferation.

HER3 overexpression is associated with resistance to HER2-targeted therapies, making it an attractive target for cancer treatment.

agents that may block both HER2 and HER3 signaling, in both ligand-dependent and independent pathways could be highly attractive strategies

for human therapeutic development.

or ErbB4, exists in various isoforms and exhibits diverse functions depending on tissue context.

HER4 activation can result in the activation

of both the MAPK and PI3K/AKT pathways, but its signaling outcomes are complex and context-dependent.

HER4 plays important roles in heart

development, neural development, and breast tissue differentiation.

ErbB family of receptor tyrosine kinases represent a closely synchronized signaling system that controls central cellular activities.

Dysregulation of these receptors, either through mutations, amplifications, or overexpression, provides to the development and evolution

of several cancers.

Elucidating the elaborate signaling pathways and communications within the ErbB family is fundamental for developing

targeted therapies to efficiently treat cancer and other diseases associated with aberrant ErbB signaling.

Ongoing research continues

to unveil the complexities of ErbB signaling, opening new avenues for innovative therapeutic strategies and personalized medicine approaches.

July 5, 2023 (the “ABSI Effective Date”), we entered into a Research and Development Collaboration and License Agreement

(the “ABSI Agreement”) with Applied Biomedical Science Institute (“ABSI”), pursuant to which ABSI granted us

an exclusive royalty-bearing, sublicensable license to the ABSI Patents and a non-exclusive, royalty-bearing, sublicensable license to

the ABSI Know-How to Exploit the ABSI Products for the treatment, diagnosis, prediction, detection or prevention of disease in humans

and animals worldwide (the “Territory”).

Pursuant to the ABSI Agreement, the parties shall form a committee to manage the

preclinical, IND-enabling studies and such other activities as shall lead to the initiation of a Phase 1 clinical trial of the ABSI Product.

The parties will collaborate on a Target-by-Target basis to identify and evaluate ABSI Products directed against such Target with a view

to identifying or generating suitable Products for our Company to Exploit.

“Target” means ErB2 (Her2) and ErB3.

Upon completion

of the Discovery Timeline for a Target, subject to the terms and conditions of ABSI Agreement, we shall exclusively own any ABSI Products

against such Target.

In the event the committee determines that the discovery activities are unsuccessful with respect to a Target, we

may propose an additional target, which, upon approval by ABSI, shall replace a failed Target, each such capitalized term as defined

in the BASI Agreement.

part of the ABSI Agreement, on July 26, 2023, we issued 1,674 shares of our common stock with a per share value of $149.34, representing

total compensation expense of $250,000.

March 11, 2024, we entered into an addendum to the ABSI Agreement to fund research services with quarterly payments of $50,000 beginning

March 18, 2024 with subsequent payments due on the 18 th of each calendar quarter.

the past decade, cancer therapy has seen significant innovations, and one class of therapeutics gaining significant attention is bispecific

These specialized molecules are engineered to target two distinct antigens boosting their specificity and therapeutic potential.

Among the most promising targets in oncology are HER2 and HER3 receptors, which play crucial roles in cell signaling and proliferation.

and HER3 are members of the ErbB family of receptor tyrosine kinases, and their dysregulation is associated with the development and

progression of various cancers, including breast, ovarian, gastric, and lung cancers.

HER2, also known as ErbB2, is overexpressed in

approximately 20-30% of breast cancers and is linked to aggressive tumor behavior and poor prognosis.

HER3, on the other hand, lacks

intrinsic kinase activity but forms heterodimers with other ErbB family members, particularly HER2, leading to potent signaling through

the PI3K/AKT pathway.

monoclonal antibodies targeting either HER2 or HER3 have shown promising clinical outcomes in some cancer patients;

however, cancer cells

often develop resistance mechanisms, leading to treatment failure.

To overcome this challenge, researchers have turned to bispecific

antibodies as a more effective approach to disrupt multiple signaling pathways simultaneously and prevent the emergence of resistance.

antibodies that target both HER2 and HER3 receptors offer several advantages over traditional therapies.

By simultaneously binding to

both receptors, these antibodies can block the formation of heterodimers between HER2 and HER3, effectively inhibiting downstream signaling

cascades that drive tumor growth and survival.

Additionally, bispecific antibodies can also engage immune cells, such as T cells and

natural killer cells, through their Fc region, promoting the destruction of cancer cells via antibody-dependent cell-mediated cytotoxicity

and antibody-dependent cellular phagocytosis.

Other Product Candidates

is a bispecific anti-HER2/anti-HER3 monoclonal ADC candidate.

Research studies elucidating the biology of HER3 reveal that triggering

of HER3 signaling stimulates tumor progression via augmentation of metastatic potential and induces treatment failure in human tumors.

Mounting evidence supports HER3 as an important target and its activation is considered to be required to overcome therapeutic resistance,

enhance efficacy, and increase patient survival.

To date, to our knowledge, there is no FDA-approved HER3-targeted therapy for cancer

Targeting both HER2 and HER3 with a blocking antibody is a strategy we intend to explore as we progress our pipeline.

intend to further develop our pipeline with novel bispecific monoclonal antibodies.

These bispecific antibodies are planned to simultaneously

bind to two different antigens or to two different epitopes on the same antigen.

Whether two different antigens or two epitopes on the

same antigen, the bispecific antibody could bind its targets either on the same cell ( cis ) or on to different cells ( trans ).

Our strategy involves targeting PD-1 combined with a known, validated undisclosed antigen or using HER2 instead of PD-1 while naturally

occurring antibodies typically only target one epitope on one antigen.

June 17, 2024, we entered into a securities purchase agreement with certain accredited investors for the issuance and sale in a private

placement (the “June PIPE Offering”), consisting of an offering of shares of our common stock and/or pre-funded warrants

to acquire shares of our common stock and warrants to acquire shares of our common stock, with net proceeds of approximately $1.8 million.

See Note 3 to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K for details regarding

these offerings.

signed a manufacturing agreement for clinical trial supply with regards to TH104 and the upcoming Phase 2 clinical trial on July 25,

2024 with a contract manufacturing organization located in North Carolina.

The development work includes both TH104 active product and

corresponding placebo batches expected to be released for clinical packaging by the end of the year.

September 30, 2024, we entered into a nonbinding, exclusive letter of intent (the “LOI”) with Intract pursuant to which we

will acquire all outstanding shares of common stock of the privately-held Intract for newly issued restricted common stock.

a biopharmaceutical company incorporated in England and Wales developing disruptive delivery solutions for oral biologics.

terms of the LOI, following the execution of a definitive agreement and the closing of the merger, Intract shareholders will own 49%

of the total equity in the combined entity, which will be named Tharimmune, Inc., with Intract becoming a wholly owned subsidiary.

believed the merger and business combination will form a best-in-class, transformative oral biologics company and the synergies between

our clinical-stage assets and Intract’s delivery platform will drive pipeline growth.

During the year ended December 31, 2024,

we paid $0.3 million in fees pursuant to the LOI agreement prior to cancellation.

November 30, 2024, the Company provided notice to Intract that it has terminated the non-binding, exclusive LOI to merge with Intract.

December 5, 2024, we entered into a securities purchase agreement with certain accredited investors for the issuance and sale in a

private placement (the “December PIPE Offering”), consisting of an offering of shares of our common stock and/or

pre-funded warrants to acquire shares of our common stock and warrants to acquire shares of our common stock, with gross proceeds of

approximately $2.02 million and net proceeds of approximately $1.83 million.

See Note 3 to the consolidated financial

statements included elsewhere in this Annual Report on Form 10-K for details regarding these offerings.

Determination That REVEX (Nalmefene Hydrochloride Injection) Was Not Withdrawn From Sale for Reasons of Safety or

Effectiveness.

Federal Register.

2017;82(212):51051-51052.

November 3, 2017.

an oral formulation of infliximab, addresses a critical limitation of the IV gold standard by eliminating the treatment burden of repeated

intravenous infusions.

By enabling patient self-administration, an oral TNF-alpha inhibitor may potentially improve medication adherence

and persistence while expanding treatment access to patients who currently defer IV therapy due to infusion center barriers, needle anxiety,

or lifestyle constraints.

the fourth quarter of 2025 and into early 2026, the Company completed a series of significant financing transactions and related strategic

initiatives designed to fund its digital asset treasury and CC treasury strategy, validator operations and related activities.

November 2025, the Company completed a private placement offering with accredited investors providing for a private investment in public

equity transaction, consisting of (i) the sale of an aggregate of 25,966,048 shares of common stock and cash pre-funded warrants (the

“Cash Offering”) and (ii) the issuance of cryptocurrency pre-funded warrants in exchange for CC (the “Cryptocurrency

Offering”) contributed by participating investors.

We raised in aggregate gross proceeds of approximately $545 million before fees

and expenses.

Under the terms of the offering, a limited portion of available cash was designated for legacy operating expenses and existing

management compensation, with the balance of proceeds allocated to transaction expenses and the acquisition of CC and implementation

of the Company’s CC treasury and validator strategy.

2026 Offering

Subsequently,

on January 20, 2026, the Company entered into an underwriting agreement with Clear Street LLC, as sole underwriter, for an underwritten

registered direct offering to a single institutional investor consisting of 1,800,000 shares of common stock and pre-funded warrants

to purchase up to 17,000,000 additional shares at a per share offering price of $2.9200 (less $0.0001 per pre-funded warrant share).

The Company announced the closing of this offering for gross proceeds of approximately $54.9 million on January 22, 2026.

Collectively,

these financings and governance actions were undertaken to strengthen the Company’s capital base and support execution of its revised

treasury and network participation strategy.

with the closing of the PIPE Transaction, on November 6, 2025, the Company entered into an at-the-market sales agreement (the

“Original Sales Agreement”) with Clear Street LLC (“Clear Street”) and President Street Global, LLC

(“President Street”) providing for the offer and sale of shares of its common stock having an aggregate offering price

of up to $64,910,161 from time to time under Rule 415 under the Securities Act.

On December 3, 2025, President Street provided a

notice pursuant to the Sales Agreement to terminate its role as a sales agent, and Clear Street became the sole sales agent.

On March 3, 2026, the Company entered into an amended and restated sales agreement (the “Sales Agreement”), with Clear Street

and Virtu Americas LLC (“Virtu”, and together with Clear Street, the “Sales Agents”), relating to the sale of

shares of the Company’s common stock.

The Sales Agreement amends and restates the Original Sales Agreement.

Pursuant to the Sales

Agreement, the aggregate gross sales price of Common Stock available for issuance under the Sales Agreement is $300,000,000, and such

amount excludes the Common Stock previously sold under the Original Sales Agreement.

connection with the adoption of the Company’s Digital Asset Treasury Strategy, Sireesh Appajosyula resigned as Chief Executive

Officer, effective November 6, 2025.

The Board of Directors (the “Board”) appointed Mark Wendland as Chief Executive Officer

and Mark Toomey as President, effective the same date.

Also on November 6, 2025, Nancy Davis and Sanam Parikh resigned as members of

the Board, and Mr.

Wendland was appointed to the Board.

On December 10, 2025, the Board appointed Jacob Asbury as Chief Financial Officer,

Appajosyula resigned as Interim Chief Financial Officer, continuing his service as a director and as Chief Executive Officer

of Gravitas Life Sciences, Inc., a subsidiary of the Company.

At the shareholders meeting held on January 30, 2026, shareholders approved

the election of Jill Sommers and William Wiley, to serve as directors.

Concurrently with the election of these two director nominees,

James Gordon Liddy resigned from the Board.

On February 5, 2026, the Board appointed Angela Dominy Radkowski as Chief Operating Officer, Vincent LoPriore stepped down as Chairman and Mark Wendland was elected as the new Chairman.

face different competition for our biotech research and development operations and our digital asset treasury.

pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis

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therapies and new therapies that may become available in the future.

of our competitors have significantly greater financial resources and expertise in research and development, manufacturing, pre-clinical

testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than we do.

Mergers and acquisitions

in the pharmaceutical, biotechnology and diagnostic industries may result in even more resources being concentrated among a smaller number

of our competitors.

These competitors also compete with us in recruiting and retaining qualified scientific and management personnel

and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary

to, or necessary for, our programs.

Earlier stage companies, such as smaller discovery phase biotechnology companies, may also prove

to be significant competitors, particularly through collaborative arrangements with large and established companies.

We anticipate some

of our competitors for TH104 will include Mirum Pharma, Ipsen Pharma, Cara Therapeutics, Moonlake Therapeutics, Apogee Therapetuics,

and Regeneron.

In addition, some of our competitors for our early-stage pipeline include Bayer AG, Moderna Inc., Roche/Genentech, Daiichi

Sankyo/Astra Zeneca, Merck, Bristol-Myers Squibb and Takeda Pharmaceutical Company.

commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are more effective,

have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop.

Our competitors

also may obtain FDA or other regulatory approval for their products more rapidly than we may obtain approval for ours.

In addition, our

ability to compete may be affected in many cases by insurers or other third-party payers seeking to encourage the use of generic products.

Generic products are currently on the market, including the active ingredients which may be used for the indications that we are pursuing,

and additional products are expected to become available on a generic basis over the coming years.

If our drug candidates achieve marketing

approval, we expect that they will be priced at a significant premium over competitive generic products.

most common methods of treating patients with cancer are surgery, radiation and drug therapy, including chemotherapy and targeted drug

There are a variety of available drug therapies marketed for solid tumors.

In many cases, these drugs are administered in combination

to enhance efficacy.

Some of these drugs are branded and subject to patent protection, and others are available on a generic basis, including

drugs in the same therapeutic class as the payloads in product candidates contained in our pipeline.

of these approved drugs are well established therapies and are widely accepted by physicians, patients and third-party payers.

although there has been considerable progress over the past few decades in the treatment of solid tumors and the currently marketed therapies

provide benefits to many patients, these therapies all are limited to some extent in their efficacy and frequency of adverse events,

and none of them are successful in treating all patients.

As a result, the level of morbidity and mortality from solid tumor cancers

remains high.

are also a number of products in clinical development to treat solid tumors including, but not limited to, Loxo Oncology (LOXO-292),

Bristol-Myers Squibb (BMS-986016 and nivolumab) Mersana / GlaxoSmithKline (XMT-2056), Zymeworks (zenidatamab) and Eli Lilly & Co

(sintilimab) in addition to those products already on the market such as Merck & Co Inc.

(Keytruda), Bristol-Myers Squibb Co.

(Imbruvica), Roche Group (Tecentiq), Regeneron Pharmaceuticals, Inc.

The products in development may provide efficacy,

safety, convenience and other benefits that are not provided by currently marketed therapies.

As a result, they may provide significant

competition for our product candidates for which we obtain marketing approval.

digital asset strategy generally involves, from time to time and subject to market conditions, (i) issuing equity or debt securities

or entering into other capital raising transactions with the objective of using the proceeds to acquire CC and other Canton Network–based

digital assets and to fund validator, staking and network participation activities, and (ii) deploying excess liquid assets beyond working

capital requirements into CC and related on-network positions.

In pursuing this strategy, we compete for capital and asset acquisition

opportunities with a range of market participants, including digital asset treasury companies, tokenization and real-world asset platforms

digital asset investment vehicles and ETPs, private funds and venture-backed entities focused on blockchain infrastructure.

competition for investor capital, strategic allocations to network-native assets, validator slots, and high-quality on-network yield

opportunities could increase our cost of capital, reduce the availability of attractive acquisition or participation opportunities, and

adversely affect our ability to scale our digital asset treasury and Canton-based treasury activities, which in turn could negatively

impact our operating results and the market price of our securities.

Manufacturing

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which may have an adverse effect on our operating results and estimated timelines.

intellectual property that is available to us is important for our business, and we strive to protect it, including by obtaining, maintaining,

defending, and enforcing patent protection in the United States and internationally for our proprietary technology, improvements, platforms,

products and components thereof, novel biological discoveries, new therapeutic approaches and potential indications, and other inventions

that are important to our business.

For our product candidates, generally we initially pursue patent protection covering compositions

of matter, methods of production, and methods of use.

Throughout the development of our product candidates and technologies, we will

seek to identify additional means of obtaining patent protection.

patent portfolio includes 3 patent families with 2 issued U.S.

patents and 14 pending applications related generally to treatment of

The claims of these patents and applications cover devices and their method of manufacture, as well as methods of treating.

Specifically, our patent portfolio currently includes two issued U.S.

patents, as well as a pending application in the U.S.

and 13 pending

applications abroad.

Patent protection is expected to expire in 2039, absent any applicable patent term adjustments or extensions.

may file other patent applications in the future.

strive to protect the intellectual property that is available to us, including by obtaining, maintaining, defending, and enforcing patent

protection in the United States and internationally.

For our product candidates, generally we initially pursue patent protection covering

compositions of matter, methods of production, and methods of use.

Throughout the development of our product candidates and technologies,

we will seek to identify additional means of obtaining patent protection.

patent portfolio includes four patent families with two issued U.S.

patents and 14 pending applications related generally to

transmucosal film compositions, treatment of pruritus, and treatment of opioid intoxication.

The claims of these patents and

applications cover devices and their method of manufacture, as well as methods of treating.

Specifically, our patent portfolio

currently includes two issued U.S.

patents, one allowed U.S.

patent application, two additional pending applications in the U.S., 5

issued patents abroad, and 10 pending applications abroad.

Patent protection is expected to expire between 2039 and 2046, absent any

applicable patent term adjustments or extensions.

The term of individual patents depends upon the legal term for patents in the

countries in which they are obtained.

In most countries, including the U.S., the patent term is 20 years from the earliest filing

date of a non-provisional patent application.

also have issued patents and pending applications related generally to our polymeric nanoparticle technologies, methods of making our

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or extensions, with more recently filed families expiring approximately between 2033 and 2041.

We have collaborations with Minotaur Therapeutics,

and Applied Biomedical Science Institute regarding applications of this technology with a variety of multispecific binders including

binders for HER2 and HER3, as well as an anti-PD-1 binder.

These collaborations will likely lead to filing of additional patent applications

in the future.

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

In most countries, including

the U.S., the patent term is 20 years from the earliest filing date of a non-provisional patent application.

In the U.S., the term of

a patent may be lengthened by patent term adjustment (“PTA”), which compensates a patentee for administrative delays by the

USPTO in examining and granting a patent or the term of a patent may be shortened if a patent is terminally disclaimed over an earlier

filed patent.

The term of a patent that covers a drug or biological product may also be eligible for patent term extension (“PTE”)

after FDA approval for a portion of the term effectively lost as a result of the FDA regulatory review period, subject to certain limitations

and provided statutory and regulatory requirements are met.

PTE can be for no more than five years, typically only one patent per approved

product can be extended, the extension cannot extend the total patent term beyond 14 years from approval, and only those claims covering

the approved drug, a method for using it or a method for manufacturing it may be extended.

In addition, the length of the adjustment

or extension granted could be less than that requested, and we may not receive the full PTA or PTE available if we fail to exercise due

diligence during the testing phase or regulatory review process, fails to apply within applicable deadlines, fails to apply prior to

expiration of relevant patents, or otherwise fails to satisfy applicable requirements.

with many biotechnology and pharmaceutical companies, our ability to maintain and solidify our proprietary and intellectual property

position for our products will depend on our success in obtaining effective patent claims and enforcing those patent claims.

our owned pending patent applications, and any patent applications that may be filed in the future or licensed from third parties, may

not result in issuance.

The breadth of claims that may be allowed or enforced in our patents also cannot be predicted.

Any of our issued

patents or patents obtained in the future may be challenged, invalidated, infringed or circumvented.

In addition, because of the extensive

time required for clinical development and regulatory review of a therapeutic product that may be developed, it is possible that, before

any of our products can be commercialized, any related patent may expire or remain in force for only a short period following commercialization,

thereby limiting the protection such patent would afford the respective product and any competitive advantage such patent may provide.

Further, the collaborations we have entered into may not result in patentable subject matter or potential licensing agreements may not

be successfully negotiated.

intend to file an intent-to-use U.S.

trademark application for “THARIMMUNE INC” (for “Pharmaceutical preparations for

use in cancer treatment and therapies”) in International class 5.

Research and Collaboration Agreement and Taurus License Agreement

entered into a research collaboration and product license agreement with Minotaur Therapeutics, Inc.

(“Minotaur”) and a commercial

license agreement with Taurus Biosciences, LLC (“Taurus”) for use of certain technology, including OmniAb antibodies, to

advance Picobodies against novel, unreachable and undruggable epitopes in high-value validated targets starting with PD-1.

and collaboration agreement and product license agreement are for the development of proprietary targeted biologics, including HS1940,

against PD-1.

research collaboration between us and Minotaur will be executed under the license from Taurus to discover, develop and advance biotherapeutics

against high-value validated IO targets.

Picobodies are bovine-derived antibody “knob” domains comprised of cysteine-rich

ultralong complementary determining region H3 sequences of 30-40 amino acids weighing ~3-4KDa, which have the potential to access challenging

epitopes better than full size antibodies can.

combining non-proprietary half-life extending methods which are linked to a PD-1 Picobody ™ to create HS1940, we believe

we could more efficiently target novel epitopes with greater binding affinity than currently approved anti-PD-1 antibodies.

believe that the development of HS1940 is a step toward enabling us to enter the rapidly growing immune-oncology market with additional

targets thereafter.

Biomedical Research Institute Research and Development Collaboration and License Agreement

July 5, 2023 (the “ABSI Effective Date”), we entered into a Research and Development Collaboration and License Agreement

(the “ABSI Agreement”) with Applied Biomedical Science Institute (“ABSI”) pursuant to which ABSI granted us an

exclusive royalty-bearing, sublicensable license to the ABSI Patents and a non-exclusive, royalty-bearing, sublicensable license to the

ABSI Know-How to Exploit the ABSI Products for the treatment, diagnosis, prediction, detection or prevention of disease in humans and

animals worldwide (the “Territory”).

Pursuant to the ABSI Agreement, the parties shall form a committee to manage the preclinical,

IND- enabling studies and such other activities as shall lead to the initiation of a Phase 1 clinical trial of the ABSI Product.

parties will collaborate on a Target-by-Target basis to identify and evaluate ABSI Products directed against such Target with a view

to identifying or generating suitable Products for our Company to Exploit.

“Target” means ErB2 (Her2) and ErbB3.

Upon completion

of the Discovery Timeline for a Target, subject to the terms and conditions of ABSI Agreement, we shall exclusively own any ABSI Products

against such Target.

In the event the committee determines that the discovery activities are unsuccessful with respect to a Target, we

may propose an additional target, which, upon approval by ABSI, shall replace a failed Target, each capitalized term as defined in the

ABSI Agreement.

part of the ABSI Agreement, on July 26, 2023, we issued 1,674 shares of our common stock with a per share value of $149.34, representing

total compensation expense of $250,000.

March 11, 2024, we entered into an addendum to the ABSI Agreement to fund research services with quarterly payments of $50,000 beginning

March 18, 2024 with subsequent payments due on the 18 th of each calendar quarter.

Patent License Agreement

November 3, 2023 (the “Avior Effective Date”), we entered into the Avior Patent License Agreement with Avior pursuant to

which we received an exclusive sublicensable right and license to Licensed Patent Rights and Licensed Technology to, among other

things, develop, have developed, make, have made, use, sell, import, export and commercialize TH104 and TH103 and to practice the

Licensed Technology in connection with the foregoing throughout the world.

Pursuant to the Avior Patent License Agreement, we paid

Avior an up front license fee of $400,000 within ten days of the Avior Effective Date and an additional mid-six digit license fee

which shall be paid in four equal installments within ten days of the end of each fiscal quarter following the Avior Effective Date.

In addition, we shall pay Avior a high single digit percentage of any upfront payments received by us as a result of the grant of

any sublicenses with respect to TH104.

We shall also pay Avior milestone payments in the aggregate amount of $24.25 million upon the

occurrence of various development milestones (the “Development Milestone Payments”).

Furthermore, we shall pay Avior

certain fees based upon sales milestones.

The payments for such sales milestones range from the low seven digits to the low eight

digits with higher sales being subject to higher fees.

Finally, we shall pay Avior royalties based on net sales.

Such royalties

range from low single digit percentages to mid-single digit percentages with higher sales being subject to lower percentages.

Avior Patent License Agreement shall expire upon the expiration of the final payment obligation due to Avior as set forth in such

Upon the expiration of the Avior Patent License Agreement, we shall have a fully paid-up, irrevocable, freely

transferable and sublicensable worldwide license to the Licensed Patent Rights and Licensed Technology to Develop, have Developed,

make, have made, use, have used sell, offer for sale, have sold, import, have imported, export, have exported, commercialize or have

commercialized any and all Licensed Products and to practice the Licensed Technology worldwide.

Pursuant to the Avior Patent License

Agreement, we may terminate the agreement at any time without cause, upon 30 days’ prior written notice to Avior along with

payment of the next unpaid Development Milestone Payment, if any.

Furthermore, either we or Avior may terminate the Avior Patent

License Agreement (i) on written notice to the other party if the other party materially breaches any provision of the Avior Patent

License Agreement and fails to cure such breach within 30 days after the breaching party receives written notice thereof or (ii) on

written notice in the event that either party (A) becomes insolvent or admits its inability to pay its debts generally as they

(B) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or

insolvency law, which is not fully dismissed or vacated within 60 days;

for such purpose;

(D) makes a general assignment for the benefit of creditors;

or (E) has a receiver, trustee, custodian or similar

agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or

Upon termination of the Avior Patent License Agreement, the license granted pursuant to such agreement shall terminate and

all rights in the Licensed Patent Rights and Licensed Products shall revert back to Avior.

License Agreement

June 17, 2024 (the “Enkefalos Effective Date”), we signed a letter of intent (the “Enkefelos LOI”) to enter into

the Enkefalos License Agreement with Enkefalos Biosciences Inc.

pursuant to which we are licensing the global rights in all fields of

use for the products related to the compounds knows as cyclotides to deliver HER2 antibodies across the blood-brain barrier and all associated

know-how, technology, intellectual property and related information and constructs, and any associated authorized generic rights and

all related assets (collectively, the “Products” referred to in this letter as ENBI-01) from Enkefalos Biosciences, Inc.

Pursuant to the Enkefalos License Agreement, we paid Enkefalos an upfront license fee of $150,000 upon signing of the Enkefalos LOI and

an additional $150,000 license fee to be paid 6 months after the Enkefalos Effective Date.

In addition, we shall pay Enkefalos a $50,000

annual license fee and milestone payments in the aggregate amount of up to $8,500,000 upon the occurrence of various development milestones

(the “Enkefalos Development Milestone Payments”).

Furthermore, we shall pay Enkefalos royalties based on net sales.

royalties range from low-single digit percentages to mid-single digit percentages with higher sales being subject to lower percentages.

The Enkefalos License Agreement shall expire upon the expiration of the final payment obligation due to Enkefalos as set forth in such

Upon the expiration of the Enkefalos Patent License Agreement, we shall have a fully paid, irrevocable, freely transferable

and sublicensable worldwide license to the Licensed Patent Rights and Licensed Technology to Develop, have Developed, make, have made,

use, have used sell, offer for sale, have sold, import, have imported, export, have exported, commercialize or have commercialized any

and all Licensed Products and to practice the Licensed Technology worldwide.

Pursuant to the Enkefalos License Agreement, either the

Company or Enkefalos may terminate the Enkefalos License Agreement on written notice to the other party.

Upon termination of the Enkefalos

License Agreement, the license granted pursuant to such agreement shall terminate and all rights in the Licensed Patent Rights and Licensed

Products shall revert back to Enkefalos.

Patent License Agreement

September 11, 2024 (the “Intract Effective Date”), we entered into a Patent License Agreement (the “Intract

Agreement”) with Intract Pharma Limited, (“Intract”), pursuant to which the Company exclusively licensed

INT-023/TH023, an oral anti-Tumor Necrosis Factor-alpha (TNF-α) monoclonal antibody infliximab.

Under the terms of the Intract

Agreement, we licensed global development and commercialization rights (outside of South Korea) to Intract’s Soteria® and

Phloral® delivery platform along with an existing supply agreement for infliximab to be used in the oral product development

Pursuant to the Intract Agreement, Intract recieved an upfront license fee of $400,000 and is eligible to receive

additional payments upon an equity financing of the Company and for future development, regulatory and commercial

milestones, as well as mid-single digit royalties based on net product sales.

Under the terms of the Intract Agreement, we retain a

right of first refusal to continue development and commercialization after a Phase 2 clinical trial and have the option to exercise

the license to Intract’s platform for up to four additional targets.

The term of the Intract Agreement expires upon the final

payment obligation of the Company under the Intract Agreement.

In addition, the Intract Agreement may be terminated by us at any

time upon 90 days written notice to Intract.

Either party may terminate the Intract Agreement if the other party materially breaches

any provision of the Intract Agreement and fails to cure such breach within thirty (30) days after the breaching party receives

written notice thereof.

In addition, either party may terminate the Intract Agreement on written notice in the event that either

party declare:

(a) becomes insolvent or admits inability to pay its debts generally as they become due;

(b) becomes subject,

voluntarily or involuntarily, to any proceeding under any domestic or foreign bankruptcy or insolvency law, which is not fully

dismissed or vacated within sixty (60) days;

makes a general assignment for the benefit of creditors;

or (e) has a receiver, trustee, custodian or similar agent appointed by

order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business.

also entered into multiple research collaboration and license agreements to secure rights to technologies, patents, and know-how supporting

development of its biologic and antibody-based product candidates.

Under agreements with Minotaur Therapeutics, Inc., the Company obtained

rights to certain technologies, to discover and develop targeted biologics against high-value immune-oncology targets, including PD-1.

The Company also entered into a Research and Development Collaboration and License Agreement with Applied Biomedical Science Institute

granting it an exclusive, sublicensable, royalty-bearing license to specified patents and a non-exclusive license to related know-how.

Additional exclusive or sublicensable global licenses have been obtained from Avior, and Intract Pharma Limited.

These agreements collectively

provide the Company with development and commercialization rights, subject to field, territory, and diligence obligations, and are material

to its intellectual property portfolio and product development strategy.

Assets and CC

laws and regulations applicable to digital assets are evolving and subject to interpretation and change.

around the world have reacted differently to digital assets;

certain governments have deemed them illegal, and others have allowed their

use and trade without restriction, while in some jurisdictions, such as the U.S., digital assets are subject to overlapping, uncertain

and evolving regulatory requirements.

digital assets have grown in both popularity and market size, the U.S.

Executive Branch, Congress and a number of U.S.

federal and state

agencies, including the Financial Crimes Enforcement Network, the Commodity Futures Trading Commission (“CFTC”), the SEC,

the Financial Industry Regulatory Authority, the Consumer Financial Protection Bureau, the Department of Justice, the Department of Homeland

Security, the Federal Bureau of Investigation, the IRS and state financial regulators, have been examining the operations of digital

asset networks, digital asset users and digital asset exchanges, with particular focus on the extent to which digital assets can be used

to violate state or federal laws, including to facilitate the laundering of proceeds of illegal activities or the funding of criminal

or terrorist enterprises, and the safety and soundness and consumer-protective safeguards of exchanges or other service-providers that

hold, transfer, trade or exchange digital assets for users.

Many of these state and federal agencies have issued consumer advisories

regarding the risks posed by digital assets to investors.

In addition, federal and state agencies, and other countries have issued rules

or guidance regarding the treatment of digital asset transactions and requirements for businesses engaged in activities related to digital

on the regulatory characterization of CC, the markets for CC in general, and our activities in particular, our business and our CC strategy

may be subject to regulation by one or more regulators in the United States and globally.

Ongoing and future regulatory actions may alter,

to a materially adverse extent, the nature of digital assets markets, the participation of industry participants, including service providers

and financial institutions in these markets, and our ability to pursue our digital asset strategy.

Additionally, U.S.

state and federal

and foreign regulators and legislatures have taken action against industry participants, including digital assets businesses, and enacted

restrictive regimes in response to adverse publicity arising from hacks, consumer harm, or criminal activity stemming from digital assets

federal and state energy regulatory authorities are also monitoring the total electricity consumption of cryptocurrency

mining, and the potential impacts of cryptocurrency mining to the supply and dispatch functionality of the wholesale grid and retail

distribution systems.

Many state legislative bodies have passed, or are actively considering, legislation to address the impact of cryptocurrency

mining in their respective states.

CFTC takes the position that some digital assets fall within the definition of a “commodity” under the Commodity Exchange

Act of 1936, as amended (the “CEA”).

Under the CEA, the CFTC has broad enforcement authority to police market manipulation

and fraud in spot digital assets markets in which we may transact.

Beyond instances of fraud or manipulation, the CFTC generally does

not oversee cash or spot market exchanges or transactions involving digital asset commodities that do not utilize margin, leverage, or

In addition, CFTC regulations and CFTC oversight and enforcement authority apply with respect to futures, swaps, other derivative

products and certain retail leveraged commodity transactions involving digital asset commodities, including the markets on which these

products trade.

SEC and its staff have taken the position that certain other digital assets fall within the definition of a “security” under

federal securities laws.

Public statements made by senior officials and senior members of the staff at the SEC indicate that

the SEC does not consider certain digital assets to be a security under the federal securities laws.

However, such statements are not

official policy statements by the SEC and reflect only the speakers’ views, which are not binding on the SEC or any other agency

or court and cannot be generalized to any other digital assets.

addition, since transactions in digital assets provide a degree of anonymity, they are susceptible to misuse for criminal

activities, such as money laundering.

This misuse, or the perception of such misuse, could lead to greater regulatory oversight of

CC and the Canton Network, and there is the possibility that law enforcement agencies could close or blacklist CC platforms or other

related infrastructure with little or no notice and prevent users from accessing or retrieving CC held via such platforms or

infrastructure.

For example, the U.S.

Treasury Department’s Office of Foreign Assets Control has issued updated advisories

regarding the use of virtual currencies, added a number of digital asset exchanges and service providers to the Specially Designated Nationals

and Blocked Persons list and engaged in several enforcement actions, including a series of enforcement actions that have either shut down

or significantly curtailed the operations of several smaller digital asset exchanges associated with Russian and/or North Korean nationals.

Additionally, in January 2025, the Consumer Financial Protection Bureau announced that it is seeking public input on privacy protections

and surveillance in digital payments, particularly those offered through large technology platforms.

Legislation is currently pending in the U.S.

Congress which, if passed and signed into law, could significantly affect the digital currency

and digital asset markets.

One such piece of legislation is the Digital Asset Market Clarity Act of 2025 (“CLARITY Act”),

which would clarify which digital currencies and digital assets are commodities, as opposed to securities.

Additionally, the CLARITY Act

would subject certain spot-market digital commodities to a comprehensive regulatory regime for the first time.

For example, the legislation

would require several different types of entities to register with the CFTC and/or SEC and comply with various regulatory requirements

that would be promulgated by the CFTC and SEC.

Further, the legislation would require issuers of new and “non-mature” digital

commodities to make a mandatory filing with the SEC containing information regarding the issuer, planned use of proceeds, economics, governance

and development roadmap.

The details of the legislation are likely to change from its current form as it is reviewed and revised by the

Congress, and it is unknown at this time whether it will be approved.

Biopharmaceutical

authorities in the U.S.

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of the suit, or expiration of the patent.

Reimbursement

sales of any of our product candidates, if approved, will depend, at least in part, on the extent to which such products will be covered

by third-party payors, such as government health care programs, commercial insurance and managed healthcare organizations.

These third-party

payors are increasingly limiting coverage and/or reducing reimbursements for medical products and services.

A third-party payor’s

decision to provide coverage for a drug product does not imply that an adequate reimbursement rate will be approved.

Further, one payor’s

determination to provide coverage for a drug product does not assure that other payors will also provide coverage for the drug product.

In addition, the U.S.

government, state legislatures and foreign governments have continued implementing cost-containment programs, including

price controls, restrictions on reimbursement and requirements for substitution of generic products.

Adoption of price controls and cost-containment

measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our future

revenues and results of operations.

Decreases in third-party reimbursement or a decision by a third-party payor to not cover a product

candidate, if approved, or any future approved products could reduce physician usage of our products, and have a material adverse effect

on our sales, results of operations and financial condition.

the United States, the Medicare Part D program provides a voluntary outpatient drug benefit to Medicare beneficiaries for certain products.

We do not know whether our product candidates, if approved, will be eligible for coverage under Medicare Part D, but individual Medicare

Part D plans offer coverage subject to various factors such as those described above.

Furthermore, private payors often follow Medicare

coverage policies and payment limitations in setting their own coverage policies.

Laws and Regulations

of our product candidates, if approved, or any other future product candidate will be subject to healthcare regulation and enforcement

by the federal government and the states and foreign governments in which we might conduct our business.

The healthcare industry is highly

regulated under both state and federal laws and regulations.

Our operations and relationships with healthcare plans and providers are

subject to extensive and increasing regulation by numerous federal, state, and local government agencies including the FDA, the Office

of Inspector General (“OIG”), the DOJ, the CMS, the Office of Civil Rights, and various state authorities.

healthcare laws and regulations that may affect our ability to operate include the following:

will be subject to numerous federal and state laws that prohibit the presentation of false information, or the failure to disclose information,

in connection with the submission and payment of medical claims for reimbursement.

federal civil and criminal false claims laws and civil monetary penalties laws, such as the federal False Claims Act, 31 U.S.C.

3729-3733, impose civil liability on individuals or entities that submit false or fraudulent claims for payment to the federal government.

The False Claims Act provides, in part, that the federal government may bring a lawsuit against any person whom it believes has knowingly

or recklessly:

presented, or caused to be presented, a false or fraudulent claim for payment or approval to the federal government;

used or caused to be made or used a false statement or a false record to get a claim for payment approved, including a false or fraudulent

concealed, or knowingly and improperly avoided or decreased, an obligation to pay or transmit money or property to the federal

or conspired to commit any of the foregoing.

federal government has used the False Claims Act to prosecute a wide variety of alleged false claims and fraud allegedly perpetrated

against Medicare and state healthcare programs.

The federal government, including as a result of the passage of the ACA, and a number

of courts have taken the position that claims presented in violation of certain other statutes, including the federal Anti-Kickback Statute

(“AKS”) or the federal physician referral law, 42 U.S.C.

1395nn (the “Stark Law”), can also be considered a violation

of the False Claims Act.

number of states have enacted laws that are similar to the federal False Claims Act.

Under Section 6031 of the Deficit Reduction Act

of 2005, as amended, if a state enacts a false claims act that is at least as stringent as the federal statute and that also meets certain

other requirements, the state will be eligible to receive a greater share of any monetary recovery obtained pursuant to certain actions

brought under the state’s false claims act.

As a result, many states have enacted laws that are similar to the federal False Claims

Act and there has been a concomitant increase in state false claims enforcement efforts.

Violations of federal and state fraud and abuse

laws may be punishable by criminal and/or civil sanctions, including significant penalties, fines, disgorgement, additional reporting

requirements and oversight under a corporate integrity agreement or similar agreement to resolve allegations of noncompliance with these

laws, and/or exclusion or suspension from federal healthcare programs, such as Medicare, and debarment from contracting with the U.S.

Penalties for False Claims Act violations include fines ranging from $13,508 to $27,018 for each false claim adjusted each

year for inflation, plus up to three times the amount of damages sustained by the government.

In addition to the provisions of the False

Claims Act, which provide for civil enforcement, the federal government also can use several criminal statutes to prosecute persons who

are alleged to have submitted false or fraudulent claims to the government for payments.

Additionally, private parties may initiate qui

tam whistleblower lawsuits against any person or entity under the False Claims Act in the name of the federal government, as well

as under the false claims laws of several states, and may share in the proceeds of a successful suit.

Generally, federal and state governments

have made investigating and prosecuting healthcare fraud and abuse a priority.

Federal “Stark” Law

Federal Stark Law (42 U.S.C.

§ 1395nn) prohibits referrals or ordering by a physician of “designated health services,”

which include pharmaceuticals and drugs that are payable, in whole or in part, by Medicare or Medicaid, to an entity in which the physician

or the physician’s immediate family member has an investment interest or other financial relationship, subject to several exceptions.

Financial relationships that are implicated by the Stark Law can include arrangements ranging from marketing arrangements and consulting

agreements to medical director agreements with physicians who order our products.

The Stark Law also prohibits billing for services rendered

pursuant to a prohibited referral.

Several states have enacted laws similar to the Stark Law.

These state laws may cover all (not just

Medicare and Medicaid) patients.

Many federal healthcare reform proposals in the past few years have attempted to expand the Stark Law

to cover all patients as well.

If we violate the Stark Law, our financial results and operations could be adversely affected.

for violations include denial of payment for the services, significant civil monetary penalties, and exclusion from the Medicare and

Medicaid programs.

and State Anti-Kickback Statutes

AKS, set forth in Section 1128B of the Social Security Act, prohibits the knowing and willful offer, payment, solicitation or receipt

of any form of remuneration in return for, or to induce, (i) the referral of a person for items or services reimbursable under federal

healthcare programs, (ii) the furnishing or arranging for the furnishing of items or services reimbursable under federal healthcare programs

or (iii) the purchase, lease or order or arranging or recommending purchasing, leasing or ordering of any item or service reimbursable

under federal healthcare programs.

core of a violation of the AKS is an “inducement” to refer patients for services or items that are reimbursed under a federal

healthcare program, such as Medicare, Medicaid, or Tricare (which covers military personnel).

The ACA amended the AKS to make it clear

that a person need not have actual knowledge of the statute, or specific intent to violate the statute, as a predicate for a violation.

Court cases have resulted in the interpretation that a violation may occur where even one purpose of the remuneration is to induce or

reward referrals, and the OIG, which has the authority to impose administrative sanctions for violation of the statute, has adopted a

similar standard.

are certain AKS “safe harbors” which, if the respective requirements are met, would afford protection from the AKS.

to meet all requirements of an AKS safe harbor does not necessarily mean the arrangement violates the AKS, but it may be subject to scrutiny

by legal authorities, in light of the parties’ intent and arrangements.

In other words, if an arrangement does not fit within a

safe harbor, it does not necessarily mean that the arrangement is per se illegal-only that it is not shielded from regulatory

The federal AKS provides criminal penalties for individuals or entities that knowingly and willfully solicit or receive any

remuneration.

A violation of the AKS is punishable by imprisonment of up to ten years, fines of up to $100,000 per offense, or both.

Violation can also give rise to federal healthcare program exclusion, liability under the False Claims Act and civil penalties, which

may include monetary penalties of up to $100,000 per offense, repayments of up to three times the total payments between the parties

to the arrangement and suspension from future participation in Medicare and Medicaid.

Additionally,

some states have enacted statutes and regulations similar to the AKS, but which may be applicable regardless of the payor source for

These state laws may contain exceptions and safe harbors that are different from and/or more limited than those of federal

law and that may vary from state to state.

Care Fraud Statute

Health Care Fraud Statute, 18 U.S.C.

§ 1347, prohibits any person from knowingly and willfully executing, or attempting to execute,

a scheme to defraud any healthcare benefit program, which can be either a government or private payor plan.

Violation of this statute,

even in the absence of actual knowledge of or specific intent to violate the statute, may be charged as a felony offense and may result

in fines, imprisonment or both.

The Health Care False Statement Statute, 18 U.S.C.

§ 1035, prohibits, in any matter involving a

federal healthcare program, anyone from knowingly and willfully falsifying, concealing or covering up, by any trick, scheme or device,

a material fact, or making any materially false, fictitious, or fraudulent statement or representation, or making or using any materially

false writing or document knowing that it contains a materially false or fraudulent statement.

A violation of this statute may be charged

as a felony offense and may result in fines, imprisonment, or both.

Monetary Penalties Statute

CMPL, 42 U.S.C.

§ 1320a-7a, authorizes the imposition of civil monetary penalties, assessments, and exclusions against an individual

or entity based on a variety of prohibited conduct, including, but not limited to:

(i) presenting, or causing to be presented, claims

for payment to Medicare, Medicaid, or other third-party payors that the individual or entity knows or should know are for an item or

service that was not provided as claimed or is false or fraudulent;

(ii) offering remuneration to a federal healthcare program beneficiary

that the individual or entity knows or should know is likely to influence the beneficiary to order or receive healthcare items or services

from a particular provider;

(iii) arranging contracts with an entity or individual excluded from participation in a federal healthcare

(iv) violating the federal AKS;

(v) making, using, or causing to be made or used, a false record or statement material to a

false or fraudulent claim for payment for items and services furnished under a federal healthcare program;

(vi) making, using, or causing

to be made any false statement, omission, or misrepresentation of a material fact in any application, bid, or contract to participate

or enroll as a provider of services or a supplier under a federal healthcare program;

and (vii) failing to report and return an overpayment

owed to the federal government.

We could be exposed to a wide range of allegations to which the federal CMPL would apply.

We cannot foreclose

the possibility that we will face allegations subject to the CMPL with the potential for a material adverse impact on our business, results

of operations and financial condition.

Substantial civil monetary penalties may be imposed under the federal Civil Monetary Penalty Statute

and may vary, depending on the underlying violation.

In addition, an assessment of not more than three times the total amount claimed

for each item or service may also apply, and a violator may be subject to exclusion from federal and state healthcare programs.

Additionally,

to the extent that our product is sold in a foreign country, we may be subject to similar foreign laws.

of March 1, 2025, we employed 2 full-time employees and 1 part-time employee.

currently employ 12 full-time employees.

We are not a party to any collective bargaining agreements,

4 unchanged sentences

of our company by motivating such individuals to perform to the best of their abilities and achieve our objectives.

corporate headquarters are located at 1200 Route 22 East, Suite 2000, Bridgewater, NJ 08807 pursuant to a monthly rental agreement.

believe this to be sufficient to meet our needs for the foreseeable future and that any additional space we may require will be available

on commercially reasonable terms.

corporate headquarters are located at 34 Shrewsbury Ave, Suite 1C, Red Bank, NJ, 07701.

time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business.

37 unchanged sentences

Form 10-K has been retrospectively adjusted to reflect the effect of the reverse stock split.

of December 31, 2024, the Company had one wholly-owned subsidiary, HB Pharma Corp.

website address is www.tharimmune.com .

The contents of, or information accessible through, our website are not part of this Annual

Report on Form 10-K, and our website address is included in this document as an inactive textual reference only.

February 18, 2026, we changed our name to Canton Strategic Holdings, Inc., pursuant to an amended and restated Certificate of Incorporation

filed with the Delaware Secretary of State, effective at 12:01 a.m.

Eastern time on February 18, 2026.

website address is www.cantonstrategic.com .

The contents of, or information accessible through, our website are not part of this

Annual Report on Form 10-K, and our website address is included in this document as an inactive textual reference only.

We make our filings

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such reports to, the SEC.

The public may read and copy the materials we file with the SEC at the SEC’s Public Reference Room at

100 F Street, NE, Washington, DC 20549.

The public may obtain information on the operation of the Public Reference Room by calling the

SEC at 1-800-SEC-0330.

Additionally, the SEC maintains an internet site that contains reports, proxy and information statements and other

The address of the SEC’s website is www.sec.gov .

The information contained in the SEC’s website is not

intended to be a part of this filing.

The SEC maintains a public website at www.sec.gov containing such filings.

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

What changed 10-K

Item 1. Business