NASDAQ: CURX

We
are planning to submit an Investigational New Drug application (“IND”) for the treatment of ulcerative colitis in the fourth
quarter of 2026. If allowed to proceed by the U.S. Food and Drug Administration (“FDA”), a Phase I trial will be initiated
30 days post-IND submission. If the Phase I trial is completed with positive results, we intend to proceed with a Phase II trial for
ulcerative colitis as our lead indication. Contingent upon the success of our ulcerative colitis trials, available funding, and other
strategic considerations, Curanex may subsequently initiate additional Phase II trials in other high-value indications such as atopic
dermatitis, coronavirus (COVID-19), gout, diabetes, and NAFLD, or may seek to license out these indications to third parties at the Phase
II stage. This multiple indication strategy represents our long-term vision to explore and maximize the value of Phyto-N and build a
robust pipeline of botanical drug candidates targeting inflammatory diseases. The successful completion of these clinical trials could
position Phyto-N as a potential botanical drug candidate for multiple inflammatory indications, addressing specific unmet medical needs.
If approved, Phyto-N could provide patients with new treatment options for various inflammatory conditions.

As
we progress towards clinical development, we will continue to invest in translational research to further elucidate the mechanisms of
action, biomarkers, and patient stratification strategies for Phyto-N. These efforts will support our precision medicine approach and
help us optimize the design and execution of our clinical trials to improve the chances of success. However, the process for conducting
clinical trials is uncertain and there is no assurance that our clinical development activities will meet our planned timelines. There
is also no assurance that we will be successful in obtaining FDA regulatory approval, in obtaining sufficient funds to pursue our growth
strategy, and in commercialization of our lead or other product candidates. As a part of this development strategy, Curanex will continue
to advance its botanical drug development program in a stepwise, data-driven manner consistent with regulatory expectations. The Company
expects to provide additional operational updates as material milestones are achieved and in accordance with applicable disclosure requirements.

Curanex
was originally incorporated as a New York corporation on June 1, 2018 under the name “Durand
Damiel Health Inc,” focusing on research and development (R&D) of health products and botanical medicines. On October 24, 2023,
the Company changed its name to “Fordman Pharma Inc.,” and on November 9, 2023, the Company changed its name to Curanex Pharmaceuticals
Inc and changed its focus on discovering, developing and commercializing innovative botanical drugs for major unmet needs to treat patients
suffering from inflammatory diseases. On June 10, 2024, the Company completed its reincorporation to the State of Nevada by a merger
with a Nevada subsidiary, and as the surviving corporation, continuing its operations as a Nevada corporation. The Company does not have
any subsidiaries. On June 17, 2024, we entered into the Asset Purchase Agreement with Duraviva Pharma Inc (“Duraviva”), a
New York corporation, pursuant to which, on the same date, we acquired from Duraviva four (4) provisional patent applications and its
8 research and development animal studies and reports and the rights to use the studies for further R&D, clinical and commercial
purposes, constituting all or substantially all of the assets of Duraviva.

The
Company does not have any subsidiaries.

1

Recent
Developments

Initial
Public Offering

On
August 27, 2025, the Company completed its initial public offering (the “IPO”) and its shares of common stock are quoted
on The Nasdaq Capital Market under the symbol “CURX.” On September 12, 2025, we completed the additional closing related
to the IPO, in which the underwriters in the IPO fully exercised their over-allotment option pursuant to the underwriting agreement dated
August 25, 2025 with Dominari Securities, LLC, as representative of the underwriters.

GMP
Pilot-Scale Manufacturing Milestone

In
February 2026, Curanex successfully completed a pilot-scale batch of Phyto-N manufactured under Good Manufacturing Practice (GMP) standards.
This GMP-compliant material is intended to support Good Laboratory Practice (GLP)-compliant toxicology, pharmacokinetic, and other IND-enabling
nonclinical studies. Completion of the GMP pilot-scale batch represents an important step in strengthening the Company’s manufacturing
foundation as it advances toward IND submission.

Key
Chemistry, Manufacturing and Controls (CMC) activities completed to date include:

● Development
of quality control methods for botanical raw materials and extracted drug substance;

● Laboratory-scale
process optimization, including extraction, concentration, and drying; and

● Scale-up
and production of GMP-compliant pilot material.

With
GMP pilot-scale material now available, the Company is actively working on initiating formal GLP toxicology and pharmacokinetic studies
as part of its IND preparation.

Preclinical
Nonclinical Studies

The
Company has conducted a series of nonclinical studies to evaluate the safety and pharmacological profile of Phyto-N, progressing from
exploratory laboratory-scale work to formal dose-range finding studies in preparation for the GLP toxicology program required for IND
submission.

Exploratory
Nonclinical Studies

Initial
exploratory nonclinical studies were conducted using laboratory-scale material to assess the preliminary safety and metabolic profile
of Phyto-N:

● Acute
Toxicity: Non-GLP acute toxicity studies conducted in rats and dogs did not identify
any treatment-related adverse toxicological findings.

● Metabolism:
Hepatic microsomal metabolism studies demonstrated minimal interspecies variability,
supporting the scientific rationale for continued nonclinical development.

These
exploratory results, combined with Phyto-N’s established human use history of over 30 years in China, provided a sound scientific
foundation for advancing to formal dose-range finding and GLP toxicology studies.

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Dose-Range
Finding Toxicology Study

In
March 2026, the Company announced the successful completion of a dose-range finding toxicology study of Phyto-N, conducted in Sprague-Dawley
rats and dogs. The study evaluated repeat-dose oral tolerability over 28 days at multiple dose levels and was designed to inform dose
selection and study design for the Company’s subsequent GLP-compliant toxicology studies. The highest dose tested represented approximately
six times the proposed clinical oral dose in dogs and approximately four times in rats.

All
animals underwent comprehensive safety assessments throughout the study period, including hematology, coagulation parameters, serum biochemistry,
and gross and histopathological examination of major organs. No treatment-related adverse findings of toxicological significance were
observed at any dose level in either species.

The
maximum feasible dose identified in this study will serve as the high-dose anchor for the design of the pivotal GLP toxicology studies
that will form a core component of the Company’s IND submission. These results keep the program on schedule toward the Company’s
target IND filing in the fourth quarter of 2026.

IND
Submission Target and Clinical Development Plans

Since
completing its IPO in August 2025, Curanex has steadily advanced its lead program in alignment with U.S. FDA regulatory requirements,
focusing on preclinical development and CMC readiness. The Company continues to target submission of its first IND application for ulcerative
colitis in the fourth quarter of 2026. Subject to the completion of required studies and regulatory clearance, Phase 1 clinical development
is planned to initiate in Australia in the fourth quarter of 2026.

The
Company expects to provide additional operational updates as material milestones are achieved and in accordance with applicable disclosure
requirements.

Opportunities
and Challenges in the Pharmaceutical Industry for Botanical Drugs

Market
Overview

The
global market for inflammatory disease treatments is rapidly growing, driven by increasing prevalence, unmet medical needs, and the limitations
of current therapies. The botanical and plant-derived drugs market includes pharmaceuticals, nutraceuticals, and herbal remedies derived
from botanical sources, plants, and natural compounds for therapeutic purposes. These drugs may include herbal extracts, phytochemicals,
traditional medicines, and plant-based supplements used in managing various health conditions and promoting wellness. With over 100 types
of inflammatory diseases affecting various organ systems and requiring long-term or lifelong treatment, there is a significant demand
for innovative solutions that can provide efficacy, safety, and better quality of life for patients. Traditional anti-inflammatory drugs,
primarily chemical compounds, often have limited efficacy and severe side effects. In contrast, botanical drugs with their multi-target
mechanisms may represent a promising new frontier in the treatment of inflammatory diseases, with enormous market potential.

According
to the “In-depth Market Research Report on the Global Phytomedicine Industry 2022-2026” released by the New Vision Industry
Research Center, the market for phytomedicine and its active ingredients has been expanding rapidly, reaching approximately 34 billion
USD, as consumer preferences shift towards natural and holistic health solutions. In summary, the botanical and plant-derived drugs market
offers substantial growth potential, driven by consumer preferences for natural therapies and increasing research efforts.

Market
Opportunities for Phyto-N

Phyto-N,
our lead product candidate, is a medicinal botanical plant with distinct chemical components and potentially a wide spectrum of therapeutic
effects. We believe that Phyto-N has a potential ability to target multiple disease pathways and regulate various pathological processes,
and if these efforts are successful and lead to regulatory approval of Phyto-N determined by clinical trials, will make it a “pipeline
in a product” that will address unmet needs in complex and hard-to-treat conditions. Our preclinical research on Phyto-N has shown
early positive results, as it indicated its potential anti-inflammatory, immunomodulatory, and tissue-protective properties, which have
been observed through animal studies and which may have the potential to be used to treat autoimmune diseases, metabolic disorders, and
viral infections, where current treatment options may fall short in terms of efficacy, safety, and durability of response.

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Phyto-N
has been used as an herbal medicine by traditional Chinese medicine practitioners to treat patients over the last 30 years in China and
has been shown promising results in managing symptoms of certain inflammatory diseases, such as ulcerative colitis, with some patients
experiencing extended periods of symptom relief. These promising results of Phyto-N, as demonstrated in animal disease models and its
use in traditional Chinese medicine, have motivated us to undertake rigorous scientific research and clinical development to further
evaluate its therapeutic potential. We are currently preparing for an IND application and planning clinical trials for Phyto-N. If these
efforts are successful and lead to regulatory approval, we believe that Phyto-N will address diverse medical needs. However, Phyto-N
has not received regulatory approval as a drug in any jurisdiction, including China, and drug development is a complex, lengthy, and
uncertain process, and there can be no assurance of clinical or commercial success.

We
acquired from Duraviva its research and development animal study reports, including preliminary safety study reports.

Duraviva
previously evaluated Phyto-N’s therapeutic potential in animal models of six inflammatory diseases: ulcerative colitis, atopic
dermatitis, gout, diabetes, NAFLD, and COVID-19 at multiple institutes, including Rutgers University, which reports the Company acquired
from Duraviva pursuant to the Asset Purchase Agreement. The preliminary safety studies, including single-dose and repeated-dose toxicity
tests, have shown that Phyto-N does not exhibit any toxicity or side effects in experimental animals at the doses tested.

In
addition to our focus on developing Phyto-N as a botanical drug, we are actively identifying and isolating the active chemical compounds
responsible for its therapeutic effects. Our research is ongoing, and we anticipate that we will conclude our research prior to the filing
of our IND application.

We
believe that Phyto-N’s key competitive advantages include:

1.
History of use in Chinese Traditional Medicine: Phyto-N’s history of human use in Chinese traditional medicine may provide
an encouraging insight for multiple inflammatory diseases that may inform our clinical development process, though further rigorous studies
are needed.

2.
Potential multi-target mechanism of action: Phyto-N may modulate multiple inflammatory pathways simultaneously, potentially providing
a more comprehensive treatment effect compared to single-target agents, with the potential to address complex disease pathologies and
overcome treatment resistance.

3.
Broad therapeutic potential: Phyto-N has shown effects in animal models across several inflammatory diseases, highlighting its
versatility and potential to treat multiple indications with a single drug.

4.
Potential for tolerability: Phyto-N’s botanical origin and potential multi-target mechanism may contribute to a favorable
tolerability profile, and comprehensive clinical trials are needed to establish Phyto-N’s safety profile as a pharmaceutical product.

Development
path of Phyto-N as a botanical drug.

The
development of Phyto-N as a botanical drug presents both opportunities and challenges. To our knowledge, currently, only four (4) botanical
drugs have received FDA approval: Veregen® (sinecatechins), a green tea extract approved for the treatment of external genital and
perianal warts; Mytesi® (crofelemer), derived from the Croton lechleri tree, approved for managing diarrhea in HIV/AIDS patients
on antiretroviral therapy; Filsuvez® (birch triterpenes), a topical gel approved for wound care in patients with dystrophic epidermolysis
bullosa; and NexoBrid® (anacaulase-bcdb), a bromelain-based enzymatic agent derived from pineapple stem concentrate, approved for
eschar removal in burn wounds. This highlights both the innovative nature of our approach and the potential challenges in obtaining regulatory
approval.

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Challenges:

1.
Complex
composition: The multi-component nature of Phyto-N requires sophisticated analytical methods for quality control and consistency.

2.
Batch-to-batch
consistency: Demonstrating consistent composition and potency across different batches can be more challenging than with single-molecule
drugs.

3.
Regulatory
precedent: With only four FDA-approved botanical drugs, there is limited regulatory precedent, which may lead to a more complex approval
process.

4.
Meeting
FDA standards: Our development process must meet the same rigorous safety and efficacy standards as conventional drugs, despite the
unique nature of botanical products.

While
the traditional use of Phyto-N in Chinese traditional medicine is encouraging, we recognize that our development process must meet the
FDA’s rigorous standards for safety and efficacy. This includes conducting comprehensive preclinical and clinical studies, potentially
requiring more time and resources compared to the development of conventional single-molecule drugs. We believe that the potential benefits
of Phyto-N as a multi-component botanical drug may justify this investment and could lead to a novel therapeutic option for patients
with inflammatory diseases. However, there can be no assurance that our efforts will be successful or that Phyto-N will ultimately receive
regulatory approval or be commercially viable.

Product
Pipelines

Our
drug development pipelines encompass six (6) various therapeutic areas: ulcerative colitis, atopic dermatitis, COVID-19, diabetes, NAFLD,
and gout. We previously conducted pre-clinical studies to determine if Phyto-N has any potential in treatment of acne. The results of
these studies did not support that conclusion, and the Company determined not to pursue further studies and research and not to submit
a new patent application for treatment of acne.

1)
Ulcerative colitis, a form of inflammatory bowel disease, is characterized by chronic nonspecific inflammation of the gastrointestinal
tract. Standard care involves corticosteroids, immunomodulators, and biologic therapies targeting specific inflammatory pathways. Phyto-N
is being developed as an orally administered alternative for patients with moderate to severe ulcerative colitis, aiming to address limitations
of current treatments. These limitations include:

●
Inadequate
symptom control: Many patients experience incomplete symptom relief or frequent relapses with existing therapies.

●
Side
effect profiles: Long-term use of corticosteroids can lead to significant side effects, while biologics may increase the risk of
infections and malignancies.

●
Loss
of response: Some patients develop antibodies to biologic therapies, potentially reducing their effectiveness over time.

●
Administration
challenges: Many current treatments require frequent injections or intravenous infusions, which can be burdensome for patients.

●
Cost
considerations: Biologic therapies are often expensive, potentially limiting access for some patients.

The
Company is advancing Phyto-N through FDA-required nonclinical studies, including GLP toxicology and pharmacokinetic studies, in preparation
for an IND submission targeted for the fourth quarter of 2026, with Phase 1 clinical trials planned to initiate in Australia thereafter,
subject to the completion of required studies and regulatory clearance, to evaluate Phyto-N as an alternative treatment approach for
patients with moderate to severe ulcerative colitis.

2)
Atopic Dermatitis is a common chronic inflammatory skin disease that significantly impacts patients’ quality of life. While current
treatments include topical steroids, calcineurin inhibitors, and systemic immunosuppressants, many patients with moderate to severe atopic
dermatitis experience inadequate disease control or frequent relapses. We are developing Phyto-N as a potential orally administered option
for these patients.

3)
COVID-19 is an acute respiratory illness caused by the novel coronavirus. Current treatments focus on supportive care and antiviral therapies
such as remdesivir and monoclonal antibodies. Phyto-N presents a potential adjunctive therapy for COVID-19 with the convenience of oral
administration.

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4)
Diabetes is a metabolic disorder characterized by impaired insulin secretion or function, leading to dysregulated carbohydrate, protein,
and fat metabolism. Current treatments include metformin, insulin, sulfonylureas, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor
agonists, and other oral medications, but some patients experience inadequate glycemic control or adverse effects. Phyto-N offers an
alternative approach to diabetes management, providing an orally administered option.

5)
NAFLD is a common liver condition characterized by hepatic steatosis, inflammation, and fibrosis. Current therapies focus on addressing
metabolic comorbidities rather than directly targeting liver fat accumulation and inflammation. Phyto-N presents a potential therapeutic
option for NAFLD, addressing its underlying pathophysiology and providing an orally administered alternative.

6)
Gout is an inflammatory arthritis caused by the deposition of uric acid crystals in joints and surrounding tissues. Current treatments
aim to reduce serum uric acid levels and prevent gout flares and complications. Phyto-N offers a potential alternative or adjunct therapy
for gout management, addressing limitations of existing treatments.

The
market analysis and challenges of each core indicator is discussed below.

Market
analysis of inflammatory bowel disease (IBD) treatment and the potential of Phyto-N

In
general, IBD treatment market is expected to continue its steady growth, driven by the rising prevalence of the disease, the introduction
of innovative therapies, and the increasing availability of healthcare services in developing regions (Source: Data Bridge Market Research,
2023). The global IBD treatment market was valued at around $26.7 billion in 2023 and is expected to grow at a CAGR of 6-7% from 2023
to 2034 and reach $50 billion by the end of 2034 (Source: Research and Market, 2024).

The
IBD treatment market is segmented by disease type (Crohn’s disease, ulcerative colitis), drug class (biologics, immunomodulators,
amino salicylates, corticosteroids), route of administration (oral, parenteral), and geography (Source: Global Market Insights, 2023).
Biologics, such as anti-TNF agents (e.g. Remicade, Humira) and anti-integrin agents (e.g. Entyvio), account for the largest and fastest
growing market share due to their higher efficacy and rapid uptake (Source: Coherent Market Insights, 2022). The ulcerative colitis segment
holds a slightly larger market share (52%) compared to Crohn’s disease (48%), but Crohn’s disease is expected to see faster
growth in the coming years (Source: Research and Markets, 2021). Opportunities exist in the development of new drug classes, personalized
treatments, and improved diagnosis and monitoring techniques (Source: Emergen Research, 2022).

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North
America dominates the global IBD treatment market with a 48% share, with the United States being the largest contributor (Source: Mordor
Intelligence, 2023). Europe holds 28% of the market share and is the second-largest market. The Asia-Pacific region accounts for 18%
share currently but is expected to witness the fastest growth of 9-10% annually due to improving healthcare infrastructure and rising
disease awareness (Source: Fortune Business Insights, 2022). The IBD treatment market is highly competitive, with the presence of both
large pharmaceutical companies and smaller biotech firms (Source: Precedence Research, 2023). The key players include AbbVie, Janssen
Biotech, Takeda Pharmaceutical, Pfizer, Merck, Novartis, and Boehringer Ingelheim (Source: Market Data Forecast, 2023). These companies
are focusing on developing novel biologics, expanding their product portfolios, and investing in R&D to maintain their market share
(Source: Roots Analysis, 2022).

Market
Potential of Phyto-N for IBD

Phyto-N
is not a monoclonal antibody drug and does not directly target specific cytokines. Instead, it may indirectly modulate inflammatory pathways,
which could provide a wider therapeutic window compared to biologics. Preclinical studies suggest Phyto-N may modulate multiple inflammatory
pathways like NF-kB, MAPK, JAK-STAT by acting on key regulators. This multi-target approach may provide a novel strategy for IBD treatments.

Our
preclinical studies of Phyto-N in animal models of IBD have yielded promising results that we believe warrant further investigation.
Details of these studies are presented in the “Research and Development” section under the Ulcerative Colitis heading. We
have not conducted any clinical trials or received regulatory approval for Phyto-N in any country, including in Asia. Our future plan
involves conducting clinical trials and seeking regulatory approvals in various markets, potentially including Asia, North America, and
Europe, subject to regulatory requirements and strategic considerations.

While
we believe there is a substantial opportunity in the IBD treatment market, our ability to capture any portion of this market is subject
to numerous risks and uncertainties, including the successful completion of clinical trials, obtaining regulatory approvals, and effectively
commercializing our product candidates.

Commercialization
Challenges:

The
challenges include: the development of biosimilars of the biologics, which may put pressure on pricing (Source: MarketsandMarkets, 2023);
securing regulatory approvals for Phyto-N as an IBD treatment, especially in Western markets, requires comprehensive clinical trials
to demonstrate safety and efficacy; establishing manufacturing, supply chain, and distribution capabilities on a global scale could be
a significant challenge for a herbal product; educating healthcare providers and patients on the benefits of Phyto-N compared to existing
IBD therapies would be crucial for market acceptance.

Market
analysis of the Atopic Dermatitis (AD) treatment and the potential of Phyto-N

Market
Size and Growth:

The
global atopic dermatitis treatment market was valued at around $14.2 billion in 2022 and is expected to grow at a CAGR of 8-9% from 2023
to 2030 and reach 27.7 billion by the end of 2030 (Source: Research and Market, 2023). The AD treatment market is moderately competitive,
with the presence of both large pharmaceutical companies and smaller biotechnology firms (Source: Precedence Research, 2023). Opportunities
exist in the development of targeted therapies, combination treatments, and the expansion of the pipeline for severe AD (Source: Emergen
Research, 2022). Overall, the AD treatment market is expected to continue its robust growth, driven by the increasing prevalence of the
disease, the introduction of innovative therapies, and the growing emphasis on improving the quality of life for patients with AD (Source:
Data Bridge Market Research, 2023).

7

The
key drivers of market growth include the rising prevalence of AD, the launch of novel biologic therapies, increasing awareness and diagnosis
rates, and the growing geriatric population (Source: Persistence Market Research, 2022). The AD treatment market is segmented by drug
class (topical, oral, and injectable), severity (mild, moderate, and severe), and geography (Source: Global Market Insights, 2023). Topical
therapies, such as corticosteroids and calcineurin inhibitors, account for the largest market share, but the injectable biologics segment
is expected to grow the fastest (Source: Coherent Market Insights, 2022). The moderate-to-severe AD segment holds a significant market
share, as this population requires more advanced and expensive treatments (Source: Research and Markets, 2021).

North
America dominates the global AD treatment market, with the United States being the largest contributor (Source: Mordor Intelligence,
2023). Europe is the second-largest market, followed by the Asia-Pacific region, which is expected to witness the fastest growth due
to improving healthcare infrastructure and increasing disease awareness (Source: Fortune Business Insights, 2022).

Market
Potential of Phyto-N for AD treatment:

Atopic
dermatitis is a chronic inflammatory skin condition with a high prevalence globally, representing a significant market opportunity for
new treatments. Preliminary data from animal models suggests that Phyto-N may have the potential to improve atopic dermatitis symptoms,
skin lesions, inflammation, and overall disease management. Details of these studies are presented in the “Research and Development”
section under the AD heading. As a botanical drug candidate, Phyto-N could potentially be positioned as an alternative to current pharmaceutical
treatments, which may appeal to patients interested in plant-based therapies.

Unlike
targeted biologics like Dupilumab, which focus on specific receptors (e.g., IL-4Rα), Phyto-N appears to have a multi-target approach
based on preclinical studies. The potential ability of Phyto-N to simultaneously target multiple inflammatory pathways and achieve anti-inflammatory
effects could be advantageous if these effects are confirmed in human clinical trials.

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Commercialization
Challenges:

The
challenges include: conducting comprehensive clinical trials to demonstrate the safety and efficacy of Phyto-N in human patients with
atopic dermatitis would be crucial for regulatory approvals and market acceptance; establishing large-scale manufacturing, supply chain,
and distribution capabilities for a herbal product may pose challenges compared to conventional pharmaceuticals; educating healthcare
providers and patients about the benefits of Phyto-N over existing treatments would be necessary for market adoption.

Market
analysis of COVID-19 treatment and the potential of Phyto-N.

Market
Size and Growth

The
global COVID-19 treatment market was valued at around $31 billion in 2021 and is expected to contract at a CAGR of -8.3% from 2022 to
2031 and reach more than $16 billion by the end of 2031 (Source: Transparency Market Research, 2023).

The
key drivers of market growth include the ongoing need for effective COVID-19 treatments, the development of new therapeutic options,
increased government funding for research and development, and the rising prevalence of COVID-19 globally (Source: Persistence Market
Research, 2022). North America dominates the global COVID-19 treatment market, with the United States being the largest contributor (Source:
Mordor Intelligence, 2023). Europe is the second-largest market, followed by the Asia-Pacific region, which is expected to witness the
fastest growth due to the high prevalence of COVID-19 and increasing healthcare infrastructure (Source: Fortune Business Insights, 2022).

The
COVID-19 treatment market is segmented by drug class (antivirals, monoclonal antibodies, steroids, and others), route of administration
(oral, intravenous, and others), and geography (Source: Global Market Insights, 2023). Antiviral drugs, such as Remdesivir and Molnupiravir,
currently hold the largest market share, but the monoclonal antibodies segment is expected to grow the fastest (Source: Coherent Market
Insights, 2022). The oral route of administration is the most dominant, as it offers convenience and ease of use for patients (Source:
Research and Markets, 2021).

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Market
Potential of Phyto-N for COVID-19 treatment:

The
COVID-19 pandemic has created a massive global demand for effective preventive and therapeutic options against SARS-CoV-2 infection.
Preliminary preclinical studies suggest Phyto-N may have the potential to reduce viral loads in various organs, inhibit inflammation,
and potentially affect transmission, which warrants further investigation as a possible approach to COVID-19 management. Details of these
studies are presented in the “Research and Development” section under the COVID-19 heading. As a natural herbal compound,
Phyto-N may appeal to patients seeking complementary or alternative therapies, particularly in regions with the Chinese traditional medicine
practices. However, it’s important to note that botanical drugs must meet the same rigorous safety and efficacy standards as conventional
pharmaceuticals.

Preclinical
studies have shown potential anti-inflammatory and immune-modulating effects, but these results need to be replicated in human clinical
trials before any conclusions can be drawn about Phyto-N’s efficacy or potential advantages. If proven safe and effective in humans,
Phyto-N might initially be considered in regions where botanical medicines are more commonly accepted. However, this would still require
thorough clinical testing and regulatory approvals. Expansion into major markets would require extensive clinical trials and regulatory
approvals, and there is no guarantee of success given the complex nature of botanical drug development and the evolving landscape of
COVID-19 treatments.

Challenges:

The
COVID-19 treatment market is highly competitive, with the presence of both large pharmaceutical companies and smaller biotechnology firms
(Source: Precedence Research, 2023). It is crucial for regulatory approvals and market acceptance that we conduct comprehensive clinical
trials to demonstrate the safety and efficacy of Phyto-N in preventing and treating COVID-19 in humans. In addition, the supply chain,
and distribution capabilities for an herbal product may pose challenges compared to conventional pharmaceuticals; educating healthcare
providers and patients about the benefits of Phyto-N over existing COVID-19 treatments and preventive measures would be necessary for
market adoption.

Market
analysis for diabetes treatments and the potential of Phyto-N

The
market for diabetes treatments is dynamic and robust, driven by the increasing prevalence of diabetes mellitus globally. With diabetes
emerging as a significant public health concern due to lifestyle changes, aging populations, and rising obesity rates, the demand for
effective treatment options continues to grow. This analysis delves into key market dynamics, trends, challenges, and opportunities shaping
the diabetes treatment landscape.

Market
Size and Growth

The
global diabetes treatment market was valued at around $66 billion in 2023 and is projected to hit around USD 118 billion by 2032, growing
at a CAGR of 6.67% during the forecast period 2023 to 2032. Diabetes affects 62 million people in the Americas, with the majority living
in low- and middle-income countries. Diabetes is directly responsible for 284,049 deaths each year. (Source: Precedence Research, 2023).

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Key
growth drivers include the rising prevalence of diabetes globally, increasing obesity/sedentary lifestyles, aging populations, and demand
for innovative therapies and disease management products (Source: International Diabetes Federation, 2021).

There
are the following key market segments:

-
By Diabetes Type: Type 1 Diabetes, Type 2 Diabetes (T2D accounts for over 90% market share, Source: Centers for Disease Control and Prevention,
2022)

-
By Product Type: Insulin (human, analogs), Non-Insulin Injectables (GLP-1 agonists, Amylin analogs), Oral Antidiabetics, SGLT-2 Inhibitors,
and Devices (insulin pumps, CGM, etc.) (Source: American Diabetes Association, 2023)

-
Insulin and Insulin Analogs hold the largest revenue share currently

-
Non-Insulin Injectables like GLP-1 agonists are the fastest-growing segment

North
America dominates the market led by high treatment rates and adoption of advanced therapies in the US. Europe is the second-largest market
driven by rising T2D prevalence with big pharmaceutical companies: Novo Nordisk, Eli Lilly, Sanofi, Merck, AstraZeneca, Boehringer Ingelheim.
Asia-Pacific region is expected to be the fastest-growing market fueled by increasing diabetic populations in India and China (Source:
World Health Organization, 2022).

The
key branded products include Lantus, Toujeo, Tresiba (insulin analogs), Ozempic, Trulicity, Rybelsus (GLP-1 agonists). Strategies involve
developing innovative biologics, combination regimens, and investments in next-gen devices and digital solutions. Overall, the diabetes
market is characterized by innovation, technological advancement, and a growing emphasis on personalized care. With the rising prevalence
of diabetes worldwide, there is a pressing need for comprehensive, patient-centric approaches to diabetes management that address not
only glycemic control but also cardiovascular risk factors, comorbidities, and patient preferences.

The
potential of Phyto-N for diabetes treatments

The
diabetes treatment market is undergoing a transformative phase with the emergence of innovative therapies and the growing demand for
effective, safe, and holistic management options. Phyto-N, our botanical drug candidate, has shown potential effects in animal research,
suggesting it may have potential in the diabetes treatment landscape. Details of these studies are presented in the “Research
and Development” section under the Diabetes heading.

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Preclinical
studies suggest that Phyto-N may be well-tolerated and may have the potential to reduce blood sugar and lipids, improve insulin resistance,
and protect the structure and function of vital organs such as the pancreas, liver, and kidneys. These initial findings are promising
and provide a rationale for further investigation.

Phyto-N
is in the early stages of development as a potential diabetes treatment, and we are excited about the opportunity to advance it through
the clinical research process. Our team is dedicated to conducting the necessary large-scale human trials to rigorously assess its potential
benefits for diabetes patients. While we acknowledge the inherent risks and uncertainties in drug development, we remain hopeful about
Phyto-N’s prospects and are committed to its careful and thorough evaluation as a potential new option in diabetes care.

Market
Analysis of Nonalcoholic Fatty Liver Disease (NAFLD) Treatments and the Potential of Phyto-N

Nonalcoholic
Fatty Liver Disease (NAFLD) is a chronic liver condition caused by accumulation of excess fat in the liver. It encompasses a spectrum
from simple fatty liver (steatosis) to Nonalcoholic Steatohepatitis (“NASH”) which can progress to fibrosis, cirrhosis and
liver failure. NAFLD has become a global health concern due to its rising prevalence, driven primarily by factors such as sedentary lifestyles,
unhealthy diets, and increasing rates of obesity and type 2 diabetes. As a result, the market for NAFLD treatment has witnessed significant
growth and is expected to continue expanding in the coming years.

Market
Size and Growth:

The
NAFLD treatment market has experienced steady growth in recent years and is projected to continue expanding at a considerable rate. The
global market value is around $4.8 billion in 2022 and is projected to reach $160 billion by the end of 2030. The market is anticipated
to grow at a CAGR of approx. 55% during the forecasted period of 2022-2030 (Research and markets, 2024). Factors such as the increasing
prevalence of NAFLD, growing awareness among healthcare providers and patients, and advancements in treatment options contribute to market
growth. The NASH market in the U.S. is estimated at US$1.6 Billion in the year 2022. China, the world’s second largest economy,
is forecast to reach a projected market size of US$24 Billion by the year 2030 trailing a CAGR of 51.9% over the analysis period 2022
to 2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 46.6% and 45.2% respectively over
the 2022-2030 period. Within Europe, Germany is forecast to grow at approximately 35.4% CAGR (Source: Global Industry Analysts, Inc.,
2022).

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The
prevalence of NAFLD is increasing globally, with estimates suggesting that it affects approximately 25% of the world’s population.
Moreover, the disease is becoming more prevalent among younger populations, including children and adolescents, further driving the demand
for effective treatments (Source: Nonalcoholic fatty liver disease in children and adolescents. Clinics in Liver Disease, 2023, 27(1),
127-144).

Currently,
the treatment options for NAFLD primarily focus on lifestyle modifications, including diet and exercise, as well as pharmacological interventions
to manage associated conditions such as obesity, diabetes, and dyslipidemia. However, there is a growing need for specific pharmacotherapies
targeting NAFLD itself, presenting opportunities for drug development and market expansion.

The
pharmaceutical industry is actively engaged in developing novel therapies specifically targeting NAFLD and its complications, such as
NASH and fibrosis. The NAFLD treatment market is characterized by the presence of both established pharmaceutical companies and emerging
biotechnology firms focusing on drug development for metabolic disorders. Multiple big pharma like Gilead, Novo Nordisk, Pfizer as well
as biotech companies have therapies in late-stage development for NASH. There are over 40 drugs in development for NASH, representing
a very active pipeline across different therapeutic classes. Leading drug candidates target mechanisms like FXR agonism, THR-β agonism,
ACC inhibition and ASK1 inhibition. FDA approved Resmetirom (Madrigal), the first drug, for NASH, on March 14, 2024 (Source: https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease).
Some other key late-stage drugs are obeticholic acid (Intercept) and semaglutide (Novo Nordisk).

Factors
driving market growth include increasing awareness about NAFLD among healthcare professionals and patients, rising healthcare expenditure,
and supportive government initiatives aimed at addressing metabolic disorders. However, challenges such as the lack of approved pharmacotherapies
for NAFLD/NASH, regulatory hurdles, and the complexity of the disease present barriers to market expansion. North America accounts for
the largest market share currently driven by high disease incidence and established healthcare infrastructure, and Europe is the second-largest
market. Asia-Pacific region is anticipated to be the fastest growing market due to increasing obesity/diabetes rates and rising healthcare
spending.

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The
potential of Phyto-N for NAFLD treatments

The
market for the prevention and treatment of Nonalcoholic Fatty Liver Disease (NAFLD) is poised for substantial growth driven by the increasing
global prevalence of the condition and advancements in therapeutic options. With the recent approval of Rezdiffra by the US FDA for treating
NASH, the landscape for NAFLD treatment has witnessed a significant milestone.

While
the recent approval of Rezdiffra (resmetirom) by the FDA for NASH treatment and the presence of other late-stage drug candidates in development
represent significant advancements in the field, this does not imply that Phyto-N will receive regulatory approval. As a botanical drug,
Phyto-N may be subject to unique additional challenges in the regulatory process compared to traditional small molecule drugs or biologics.
The FDA’s regulatory pathway for botanical drugs can differ from that of conventional pharmaceuticals, potentially requiring additional
or different types of evidence to demonstrate safety and efficacy.

Phyto-N,
our botanical drug candidate, is being developed as a potential treatment for NAFLD/NASH. Preclinical studies have shown that Phyto-N
demonstrates anti-inflammatory properties in animal models of NAFLD. See details of these studies in the “Research and Development”
section under the NAFLD heading.

Preclinical
studies also suggest that Phyto-N may have both preventive and therapeutic effects in animal models of NAFLD. However, the comparative
efficacy and safety profile of Phyto-N relative to approved treatments can only be determined through direct clinical comparisons, which
we have not yet conducted. The potential benefits and risks of Phyto-N in humans will need to be carefully evaluated in future clinical
trials.

As
we advance Phyto-N through clinical development, we aim to generate the necessary data to evaluate its potential as a safe and effective
therapy for NAFLD/NASH. Our goal is to improve treatment options for patients suffering from this complex liver disorder.

Market
Analysis of Gout Treatments and Potential of Phyto-N.

The
global gout treatment market size was valued at around $2.4 billion in 2022. It is projected to grow at a robust CAGR of 8.6% during
the forecast period of 2022 to 2032 and reach $5.4 billion by the end of 2032.

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Major
growth drivers include the rising prevalence of gout, which is linked to aging populations, obesity, dietary factors like high purine
intake, as well as increasing healthcare access and awareness about effective gout management (Source: Persistence Market Research, 2022).
Development of new targeted therapies and increasing investment in R&D by pharmaceutical companies is also fueling market expansion.

The
market is segmented into uric acid lowering therapies (xanthine oxidase inhibitors like allopurinol, febuxostat; uricosurics), anti-inflammatory
drugs (NSAIDs, colchicine, corticosteroids), and biologics/newer therapies. Xanthine oxidase inhibitors hold the largest market share
as they are recommended as the first-line urate-lowering therapy for most gout patients (Source: Global Market Insights, 2023). The biologics
segment, including interlukin-1 inhibitors like Ilaris (canakinumab), is expected to witness the fastest growth in the coming years for
treatment of uncontrolled gout. Oral formulations dominate due to higher convenience and patient preference, while parenteral routes
are used for severe cases. The market is categorized into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies
currently lead the distribution. North America dominates the global gout treatment market, largely due to the high prevalence of the
disease and greater access to healthcare services in the region, especially in the United States (Source: Mordor Intelligence, 2023).
Europe is the second largest regional market.

The
potential of Phyto-N for Gout Treatment

Based
on the animal study data provided in the “Research and Development” section under the Gout heading, Phyto-N demonstrated
potential therapeutic effects in treating both gouty nephritis and gouty arthritis, which could give it a potential advantage in the
gout treatment market. The studies show that Phyto-N can reduce levels of inflammatory mediators such as TNF-α, Caspase-1, IL-6,
IL-18, IL-1β, and NLRP3 inflammasome, which play crucial roles in the inflammatory cascade associated with gout. By targeting these
inflammatory factors, Phyto-N may offer an approach to treating gout-related inflammation. In the gouty nephritis mouse study, Phyto-N
was able to reduce serum levels of uric acid, creatinine, and BUN, as well as improve renal fibrosis and tubular damage. These results
suggest that Phyto-N may have the potential to address both hyperuricemia and kidney-related issues in mouse gouty nephritis model. Further
research is needed to confirm these effects and determine their clinical significance.

Challenges:

Key
challenges include: conducting comprehensive clinical trials to demonstrate the safety and efficacy of Phyto-N in human patients with
gout would be crucial for regulatory approvals and market acceptance; establishing large-scale manufacturing, supply chain, and distribution
capabilities for a herbal product may pose challenges compared to conventional pharmaceuticals; and educating healthcare providers and
patients about the benefits of Phyto-N over existing treatments would be necessary for market adoption.

Our
Growth Strategy

Our
growth strategy is to leverage our expertise in botanical medicine to identify and develop potential novel drug candidates derived from
herbal extracts and their active ingredients. Botanical drugs may offer several potential advantages, including the potential for multi-target
mechanisms of action, and a potential source of bioactive compounds. By focusing on botanical drug development, we hope to differentiate
ourselves in the pharmaceutical industry and capitalize on the growing demand for natural treatment options. In addition to our focus
on developing Phyto-N as a botanical drug, we are actively engaged in identifying and isolating the active chemical compounds responsible
for its therapeutic effects. We are investigating the potential of these compounds to serve as the basis for the development of novel
small molecule drugs with potentially targeted mechanisms of action; however, the process of identifying these compounds is still ongoing,
and there is no assurance of success. We anticipate that we will conclude this research prior to the submission of an IND application
for ulcerative colitis.

By
conducting preclinical studies and clinical trials, we aim to evaluate Phyto-N’s safety and efficacy in various indications and
gather the necessary data to support its approval as a botanical drug by the FDA. The Company’s initial focus will be on advancing
Phyto-N into clinical trials for this debilitating condition with significant unmet medical needs. If the Phase I trial is completed
with positive results, we intend to proceed with a Phase II trial for ulcerative colitis as our lead indication. Contingent upon the
success of our ulcerative colitis trials, obtaining sufficient funding from a combination of public or private equity offerings and debt
financings, and other strategic considerations, Curanex may subsequently initiate additional Phase II trials in other high-value indications
such as atopic dermatitis, COVID-19, gout, diabetes, and NAFLD, or may seek to license out these indications to third parties at the
Phase II stage. By pursuing this multiple indication strategy, Curanex aims to explore and maximize the value of Phyto-N and build a
robust pipeline of botanical drug candidates targeting inflammatory diseases. The successful completion of these clinical trials could
position Phyto-N as a potential botanical drug candidate for multiple inflammatory indications, addressing specific unmet medical needs.
If approved, Phyto-N could provide patients with a new treatment option.

15

As
we progress towards clinical trials, we will continue to invest in translational research to further elucidate the mechanisms of action,
biomarkers, and patient stratification strategies for Phyto-N. These efforts will support our precision medicine approach and help us
optimize the design and execution of our clinical trials to improve the chances of success. However, the process for conducting clinical
trials is uncertain and there is no assurance that our clinical development activities will meet our planned timelines. There is also
no assurance that we will be successful in obtaining FDA regulatory approval, in obtaining sufficient funds to pursue our growth strategy,
and in commercialization of our lead or other product candidates.

Our
Competitive Strengths

Our
leadership team is comprised of experienced industry professionals with a proven track record of success in bringing innovative therapies
to market with deep expertise in drug discovery, development, and commercialization. Our board and advisors include experts in inflammatory
diseases, botanical medicine, and US regulatory strategy, ensuring that we have the knowledge and network to successfully navigate the
clinical development and approval process. We have also attracted top talent in the areas of botanical medicine, inflammatory diseases,
and regulatory affairs, ensuring that we have the knowledge and skills necessary to navigate the complex process of drug development
and approval. We believe that our distinctive approach, combining the power of nature with scientific research and development, will
set us apart in the pharmaceutical industry and positions us for long-term success.

We
hope to collaborate with academic institutions, research organizations, and contract research organizations (CROs) to advance our understanding
of the underlying mechanisms of inflammatory diseases and identify potential novel therapeutic targets. We believe that these partnerships
could provide access to technologies, expertise, and resources that complement our internal R&D capabilities. For example, Duraviva
in the past collaborated with researchers at Rutgers University, which have been instrumental in validating Phyto-N’s therapeutic
potential in animal models of inflammatory diseases. These research and development animal studies and reports were assigned and transferred
to the Company by Duraviva pursuant to the Asset Purchase Agreement. We are planning to partner with experienced contract manufacturing
organizations (CMOs) that have a proven track record of producing high-quality, GMP-compliant botanical drug substances and drug products.
We believe that these partnerships will ensure the reliable and efficient production of our therapeutics at various stages of development
and commercialization.

We
are also looking to establish working strategic relationships with clinical research organizations and clinical trial sites to design,
conduct, and monitor our clinical trials. These collaborations may help us efficiently execute our clinical development plans, ensure
data quality and integrity, and meet regulatory requirements.

Technological
Achievements

During
the last five years, our founders worked on combining the potential therapeutic properties of phytomedicines and their potentially active
ingredients with unmet needs in the market for various therapeutic areas. They have mastered key technologies for extracting, isolating,
chemically synthesizing, and structurally modifying active ingredients in phytomedicines. They are actively working to ensure that our
processes for extracting phytomedicine, formulation, and quality control will meet FDA standards for the industrial production of botanical
drugs. By leveraging their extensive technical and practical experience in drug development, founders of Curanex, together with our team
of executive officers, directors, and consultants, aim to focus on initiating and developing drugs with potential targeted effects and
significant market demand. However, there can be no assurance that our technological achievements will result in commercially viable
products or that we will be successful in obtaining FDA approval for any products we may develop.

16

Our
Challenges

As
a company that is developing botanical drugs, we may face challenges that similar companies experienced in the past with obtaining regulatory
approval, as the development and approval process for botanical drugs involves additional challenges, including, but not limited to the
complex nature of botanical extracts, which may contain multiple active compounds, making it difficult to identify and characterize all
active ingredients, challenges in standardization and quality control due to natural variations in plant materials, difficulties in predicting
pharmacokinetics and potential drug interactions due to the complex composition of botanical extracts, and manufacturing complexities
in scaling up production while maintaining consistency and quality. Currently only four (4) botanical drugs have received FDA approval:
Veregen® (sinecatechins), a green tea extract approved for the treatment of external genital and perianal warts; Mytesi® (crofelemer),
derived from the Croton lechleri tree, approved for managing diarrhea in HIV/AIDS patients on antiretroviral therapy; Filsuvez® (birch
triterpenes), a topical gel approved for wound care in patients with dystrophic epidermolysis bullosa; and NexoBrid® (anacaulase-bcdb),
a bromelain-based enzymatic agent derived from pineapple stem concentrate, approved for eschar removal in burn wounds. This limited number
of approvals highlights both the innovative nature of our approach and the potential challenges in obtaining regulatory approval. These
challenges involve additional costs and may result in delays, or failure to obtain the required FDA regulatory approval.

Intellectual
Property

Our
commercial success depends in part upon our ability to obtain and maintain patent and other proprietary protection for commercially important
technologies, inventions and know-how related to our business, defend and enforce our intellectual property rights, particularly our
patent rights, preserve the confidentiality of our trade secrets and operate without infringing valid and enforceable intellectual property
rights of others. Pursuant to the Asset Purchase Agreement, on June 17, 2024, we acquired the applications to provisions patents from
Duraviva. All these provisional applications expired
on March 18, 2025. On March 13, 2025, prior to the expiration, we filed with the USPTO an international PCT application for utility patent
entitled “PLANT EXTRACT COMPOSITIONS AND USES THEREOF” (application # PCT/US25/19679) which combined the following three
(3) provisional patent applications (all of which had expiration dates of March 18, 2025):

Provisional
Application #63/566,747 - Plant Extract Compositions and Uses Thereof For Treating Autoimmune Diseases” for treatment of Autoimmune
Diseases.

Provisional
Application #63/566,749 – “Plant Extract Compositions and Uses Thereof For Treating Metabolic Diseases” for treatment
of Metabolic Diseases, and

Provisional
Application #63/631,786 – “Plant Extract Compositions and Uses Thereof For Treating Or Preventing Viral Infections”
for treatment of Viral Infections.

The
Company determined not to file a new patent application for treatment of acne due to results in pre-clinical studies and experiments
that did not support the finding of any potential benefits of using Phyto-N to treat acne. As such, the provisional patent application
#63/566,754 – “Plant Extract Compositions and Uses Thereof For Treating Acne.”

While
we filed this international PCT application prior to expiration of these three (3) above-referenced provisional patents, to preserve
the priority dates with respect to our provisional patent applications, there is no assurance that we will be successful in obtaining
registration of this utility patent in the United States and the broader international patent protection we need.

Compared
to provisional patent applications, non-provisional applications require to undergo a thorough examination process by patent examiners
to determine patentability, patentability of the invention, including its novelty and non-obviousness. Non-provisional applications also
require providing formal claims, detailed drawings, and a written description that fully discloses the invention’s subject matter
and scope. Moreover, patent applications and patents may be opposed or challenged by third parties. As patent applications in the United
States are maintained in secrecy until published or issued and as publication of discoveries in the scientific or patent literature often
lag behind the actual discoveries, we cannot be certain that there are no other pending patent applications or issued patents from other
parties. Additionally, the breadth of claims allowed in biotechnology and pharmaceutical patents, or their enforceability cannot be predicted.
We cannot be sure that we will be successful in obtaining and maintaining effective patent protection for the technologies underlying
Phyto-N and successfully defending patent rights in those technologies against third-party challenges.

17

Duraviva
also transferred to the Company 8 research and development animal studies and reports, including the right to use the studies for further
R&D, clinical & commercial purposes, for:

1.
Ulcerative Colitis

2.
Atopic Dermatitis

3.
Nonalcoholic fatty liver disease prevention

4.
Nonalcoholic fatty liver disease treatment

5.
Diabetes

6.
COVID-19 prevention and treatment

7.
Gouty nephritis

8.
Gouty arthritis

Our
Business Plan

Our
business plan and strategy are centered on developing innovative botanical drugs, with a focus on Phyto-N as our lead candidate, for
the treatment of inflammatory diseases.

Preclinical
Evaluation: Our lead product candidate, Phyto-N, has undergone extensive preclinical testing in animal models of six inflammatory
diseases: ulcerative colitis, atopic dermatitis, gout, diabetes, nonalcoholic fatty liver disease (“NAFLD”) and COVID-19.
We have conducted the following preclinical studies:

1)
Pharmaceutical experiments to characterize the active ingredients of Phyto-N;

2)
Animal pharmacology studies to demonstrate potential effects in relevant disease models, including:

●
Dextran
sulfate sodium (DSS)-induced colitis model for ulcerative colitis;

●
DNCB-induced
acute atopic dermatitis model;

●
SARS-CoV-2
infection model in hamsters for COVID-19;

●
High-fat
diet and streptozotocin-induced type 2 diabetes model;

●
Gubra-Amylin
NASH (GAN) diet-induced NAFLD/NASH model;

●
Adenine
and potassium oxonate-induced gouty nephritis model;

●
MSU
crystal-induced gouty arthritis model;

3)
Preliminary safety pharmacology and toxicology studies, including single-dose and repeated-dose toxicity tests.

Details
of these animal pharmacology studies are presented in the “Research and Development” section. These studies, conducted
at institutions such as Rutgers University, have consistently shown that Phyto-N exhibits potent therapeutic effects without any significant
toxicity or side effects at the intended therapeutic doses. Additionally, Phyto-N has a long history of human use in China, where it
has been used as a herbal medicine by traditional Chinese medicine practitioners to treat thousands of patients over the past 30 years.

Regulatory
Progress: Curanex is committed to advancing Phyto-N towards clinical development in the United States and has made significant strides
in this direction. We are actively preparing to engage with the FDA to discuss our development plans and seek guidance on the regulatory
path forward.

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Building
on this preclinical foundation, we are currently focused on completing the necessary IND-enabling studies to support our planned clinical
trials. These include:

●
GLP
(Good Laboratory Practice) toxicology studies to further assess the safety of Phyto-N

●
Pharmacokinetic
studies to characterize the absorption, distribution, metabolism, and excretion of Phyto-N in human-relevant animal models

●
GMP
(Good Manufacturing Practice) production of clinical trial material

●
Stability
testing and analytical method validation

●
Finalization
of clinical trial protocols and regulatory documentation

By
leveraging our in-house expertise and strategic partnerships with leading CROs and CMOs, we are well-positioned to complete these IND-enabling
activities in a timely and efficient manner. We have a clear roadmap to IND submission and are on track to initiate Phase I trials for
our lead indications, starting with ulcerative colitis in 2026. As we progress towards clinical development, we will continue to invest
in translational research to further elucidate the mechanisms of action, biomarkers, and patient stratification strategies for Phyto-N.
These efforts will support our precision medicine approach and help us optimize the design and execution of our clinical trials to explore
the chances of success.

Our
Revenue Model

We
anticipate that our future revenue streams will primarily derive from the commercialization of our botanical drug products. Our lead
product candidate, Phyto-N, is currently in pre-clinical studies stage. We plan to file an IND application in the fourth quarter of 2026,
with ulcerative colitis to be our first application. As we progress towards clinical development, we will continue to invest in translational
research to further elucidate the mechanisms of action, biomarkers, and patient stratification strategies for Phyto-N. These efforts
will support our precision medicine approach and help us optimize the design and execution of our clinical trials to explore the chances
of success. However, there is no guarantee that we will receive regulatory approval or successfully reach commercialization or generate
any revenue. The process of obtaining regulatory approval is lengthy, expensive, and uncertain. Assuming we successfully navigate the
regulatory process and obtain approval for our products, we anticipate the following potential revenue streams:

●
Product
Sales: Upon regulatory approval, we would expect to generate revenue through the sale of our drug products to healthcare providers,
specialty pharmacies, and distributors. Our pricing strategy would be based on the value our therapies provide to patients, the healthcare
system, and society, taking into account factors such as clinical efficacy, safety, and pharmacoeconomic benefits.

●
Collaborations
and Licensing: We plan to explore strategic collaborations and licensing agreements with other pharmaceutical companies to co-develop,
co-promote, or out-license our drug candidates. These agreements could potentially provide upfront payments, milestone payments,
and royalties on future product sales, diversifying our revenue streams and mitigating development risk.

●
Research
Grants and Contracts: We intend to pursue non-dilutive funding opportunities, such as research grants and contracts from government
agencies, foundations, and other organizations. These funds could support our early-stage research and help us validate our therapeutic
concepts and generate proof-of-concept data. However, as of the date of this Annual Report, we have not received any research grants
or contracts.

Commercialization

Commercialization
of a drug requires approval from the regulatory body of each country in which the drug is to be marketed. Successful commercialization
requires high quality marketing campaigns and distribution arrangements in order to gain market share as fast as possible. Global pharmaceutical
companies have large and professional marketing and distribution functions that regularly introduce new drugs throughout the world. For
that reason, we are likely to choose to seek a strategic partnership in any or all territories in which Phyto-N is to be marketed. Decisions
on both the appropriate territories in which regulatory approval will be sought and the nature of commercialization in those territories
will be made by the board of directors at the appropriate time and with due regard to maximizing the commercial benefit to us.

19

Research
and Development (FDA Related Application)

The
objective of our research and development program is the generation of data sufficient to achieve regulatory approval of Phyto-N in one
or more dosage forms in major markets such as the United States, and/or to allow us to enter into a commercial relationship with another
party.

The
animal studies described in this section were conducted in two locations. The COVID-19 study was performed at Rutgers University in the
United States, while the studies for ulcerative colitis and our other target indications were conducted in Yunnan Branch of the Institute
of Medicinal Plant Development, Chinese Academy of Medical Sciences in China. All studies were carried out in accordance with local regulations
and ethical guidelines for animal research. It is important to note that throughout these studies, we did not observe any adverse or
severe adverse events in the animals treated with Phyto-N. While these results are encouraging, we emphasize that the safety and efficacy
of Phyto-N in humans can only be determined through future clinical trials.

Moderate
to Severe Ulcerative Colitis

Ulcerative
colitis, a chronic inflammatory bowel disease (IBD) affecting the colon and rectum, is characterized by abdominal pain, diarrhea, rectal
bleeding, and urgency. Current treatments, such as aminosalicylates, corticosteroids, immunomodulators, and biologic therapies, often
fail to provide adequate symptom control and may cause significant adverse effects, highlighting the need for novel and safe therapeutic
options. Phyto-N, an investigational botanical drug candidate, is being studied as a potential alternative for patients with moderate
to severe ulcerative colitis.

Human
Application Case

An
example of Phyto-N’s potential in ulcerative colitis is the case of 69-year-old Ms. Li from Harbin, China, who had suffered from
severe ulcerative colitis for over 20 years, experiencing frequent flares and inadequate response to conventional treatments. Her symptoms
included debilitating abdominal pain, bloody diarrhea, anemia, and fatigue, significantly impacting her quality of life. In January 2023,
Ms. Li began taking Phyto-N orally, and within one week, she noticed improvements in her condition. It’s important to note that
Phyto-N is currently used as a Chinese herb medicine and is allowed to be used in patients in China. However, it has not been clinically
approved as a pharmaceutical drug in any jurisdiction and is currently in the early stages of pre-clinical development for such approval.

After
three months of consistent use, Ms. Li reported complete clinical remission, with resolution of abdominal pain, normalization of bowel
movements, and no further rectal bleeding or pus. Additionally, her anemia resolved, she regained lost weight, and her overall strength
and vitality improved. Ms. Li remained symptom-free for 12 months after discontinuing Phyto-N, suggesting the potential for long-term
remission and a reduced risk of relapse.

While
this individual case from Harbin is of interest, and Phyto-N is used as a Chinese herbal medicine in China, it is crucial to understand
that as a pharmaceutical drug candidate, Phyto-N is still in the early stages of pre-clinical development. It will likely take several
years to complete the necessary clinical trials and regulatory processes required for commercialization as an approved pharmaceutical
product. There can be no guarantee that Phyto-N will achieve similar results in larger-scale clinical testing or that it will ultimately
be approved for use in treating ulcerative colitis outside of its current use in Chinese medicine. The development of new drugs is a
complex and uncertain process, and many promising candidates fail to reach the market as approved pharmaceutical products.

Animal
Experiment Research

Preclinical
studies in animal models of ulcerative colitis provide initial evidence of Phyto-N’s possible therapeutic potential. In a well-established
model using 8-week-old male C57BL/6 mice with dextran sulfate sodium (DSS)-induced colitis, oral administration of Phyto-N (3.3g/kg/d)
for 10 days significantly reduced disease severity compared to control groups receiving either mesalazine (100mg/kg/d, positive control)
or physiological saline. Phyto-N-treated mice exhibited decreased weight loss, improved colon morphology, and increased colon length,
indicating a reduction in inflammation and tissue damage.

In
Figure 1, statistical significance is indicated by p-values. The p-value is a statistical measure that indicates the probability of obtaining
test results at least as extreme as the observed results, assuming that the null hypothesis (typically that there is no real difference
between groups) is true. A smaller p-value suggests stronger evidence against the null hypothesis. In scientific research, p-values less
than 0.05 (p < 0.05) are generally considered statistically significant, indicating that the observed difference between groups is
unlikely to have occurred by chance.

20

In
our study:

●
p
< 0.05 (indicated by *) suggests a statistically significant difference between the groups.

●
p
< 0.01 (indicated by **) suggests a highly statistically significant difference.

The
p-values shown in Figure 1A, which depicts the effect of Phyto-N on DSS-induced colonic length in mice, indicate that the differences
in colon length between the Phyto-N treated group and the DSS control group are statistically significant (p < 0.01). This high level
of statistical significance suggests that the protective effect of Phyto-N on colon length reduction in DSS-induced colitis is very likely
to be a real effect rather than a result of random chance.

Colon
length is an important indicator of inflammation in colitis models, with shorter colon length typically indicating more severe inflammation.
The statistically significant difference in colon length between the Phyto-N treated group and the DSS control group supports our hypothesis
that Phyto-N has a protective effect against colitis-induced inflammation in this model.

The
Disease Activity Index (DAI), a composite score encompassing weight loss, stool consistency, and rectal bleeding, was significantly lower
in the Phyto-N group by day 14 of treatment and continued to improve until the end of the study (Figure 1C). Specifically, the mean DAI
scores at day 14 were 2.75 ± 0.0.85 for the Phyto-N group, compared to 4.10 ± 0.45 for the control group (p < 0.01).
By the end of the study at day 20, the mean DAI scores were 7.45 ± 0.76 for the Phyto-N group and 5.15 ± 0.0.75 for the
control group (p < 0.001). The lower DAI scores in the Phyto-N group indicate a significant reduction in disease severity on body
weight loss (Figure 1D), stool consistency, and rectal bleeding. This improvement is promising as it suggests that Phyto-N may not only
alleviate symptoms rapidly but also maintain its potential therapeutic effect over time. The sustained lower DAI scores in the Phyto-N
group compared to the control group demonstrate the potential of Phyto-N as a candidate treatment for ulcerative colitis, potentially
capable of providing both quick relief and long-term management of the disease. However, further clinical studies are needed to confirm
these findings in human patients.

Figure
1. Pharmacological Effects of Phyto-N on Moderate to Severe Ulcerative Colitis

Note:
(A) Effect on DSS-induced colonic length in mice; (B) Gross observation of colon morphology in mice; (C) Line graph of DAI scores in
mice; (D) Line graph of body weight changes in mice. The result is represented by x̅±S. x̅±S means the average
plus or minus the standard deviation, a measure of variability in the data. * indicates P<0.05; ** indicates P<0.01. P-values indicate
the statistical significance of the results, with lower values suggesting stronger evidence.

21

Histopathological
analyses of colon tissues revealed that Phyto-N treatment markedly reduced inflammatory cell infiltration, preserved mucosal architecture,
and increased goblet cell count compared to control groups (Figure 2). These preliminary findings suggest Phyto-N’s potential ability
to alleviate inflammation, promote tissue repair, and maintain intestinal barrier integrity, which are essential for achieving and sustaining
remission in ulcerative colitis.

Figure
2. Pharmacological Effects of Phyto-N on Moderate to Severe Ulcerative Colitis

Note:
Observations of H&E stained sections of mouse colon tissue (H&E,200×).

To
elucidate the molecular mechanisms underlying Phyto-N’s anti-inflammatory effects, further experiments were conducted focusing
on key pathways involved in the pathogenesis of ulcerative colitis. The results showed that after administration of Phyto-N, the protein
expression of IL-6, TNF-α, IL-1β, IL-18 in the colon tissues of mice with ulcerative colitis decreased, and the levels of
IL-6, TNF-α, IL-1β, IL-18 in the serum decreased (Figure 3), as well as the gene expression of NLRP3, NF-κB, Caspase-1,
GSDMD in the colon tissues of mice (Figure 4). These preliminary findings suggest that Phyto-N may exert its therapeutic effects by inhibiting
the activation of NF-κB and the NLRP3 inflammasome, thereby reducing the production and secretion of pro-inflammatory mediators
and preventing pyroptosis, a highly inflammatory form of programmed cell death (Figure 5).

Figure
3. Pharmacological Effects of Phyto-N on Moderate to Severe Ulcerative Colitis

22

Comparison
of serum IL-6, TNF-α, IL-1β and IL-18 levels in mice. The result is represented by x̅±S. * indicates P<0.05;
** indicates P<0.01.

Figure
4. Pharmacological Effects of Phyto-N on Moderate to Severe Ulcerative Colitis

Comparison
of NLRP3, NF-κB, Caspase1, GSDMD mRNA expression levels in mice. The result is represented by x̅±S. * indicates P<0.05;
** indicates P<0.01.

The
preliminary data from these studies suggest that Phyto-N may have the potential ability to modulate both upstream regulators (e.g., NF-κB)
and downstream effectors (e.g., IL-6, TNF-α) of the inflammatory response. This potentially multi-faceted mechanism of action warrants
further investigation in clinical studies to determine its potential therapeutic effects. While these early results are encouraging,
it’s important to note that animal studies may not always translate directly to human outcomes.

These
studies were conducted in Yunnan Branch of the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences in China.
No adverse or severe adverse events were observed in the Phyto-N treated group during this study.

The
preclinical studies in animal models of ulcerative colitis suggest potential effects of Phyto-N that warrant further investigation. In
the DSS-induced colitis model using 8-week-old male C57BL/6 mice, oral administration of Phyto-N (3.3g/kg/d) for 10 days appeared to
reduce some markers of disease severity compared to control groups. However, it’s important to note that animal models may not
fully replicate human disease conditions. The molecular studies indicated possible effects of Phyto-N on inflammatory pathways, including
reductions in certain pro-inflammatory cytokines and gene expressions related to inflammation. However, these findings are preliminary
and their clinical significance remains to be determined through extensive further research.

23

In
conclusion, the preclinical data and limited clinical observations suggest that Phyto-N may have potential in the treatment of ulcerative
colitis. However, it is crucial to emphasize that these findings are preliminary and based on early-stage research. Extensive further
research, including rigorous clinical trials, would be necessary to establish any potential therapeutic effects or safety profile of
Phyto-N in humans. The goal of improving treatment options for patients with ulcerative colitis drives our commitment to rigorous scientific
investigation and adherence to regulatory standards.

Figure
5. Mechanism of Phyto-N Treatment for Severe Ulcerative Colitis

24

Note:
Phyto-N can enter the cells and reduce the transcription of downstream nuclear inflammatory factors (IL-6, TNF-α, etc.) induced
by the activation of NF-κB, reduce the formation of NLRP3-ASC-procaspase-1 inflammasomes, thereby inhibiting a series of reactions
such as the generation of Caspase-1 leading to the splicing of pro-IL-1β and pro-IL-18 by GSDMD, reducing the levels of extracellular
inflammatory factors IL-6, TNF-α, IL-1β, and IL-18, as well as cell pyroptosis, exerting a therapeutic effect on ulcerative
colitis.

Atopic
Dermatitis

Atopic
dermatitis, a chronic inflammatory skin disorder, affects millions of people worldwide, causing significant discomfort and impacting
quality of life. Current treatment options, such as topical corticosteroids, calcineurin inhibitors, and systemic immunosuppressants,
often provide inadequate disease control and may lead to adverse effects. Dupilumab (Dupixent), the first targeted biologic therapy approved
for moderate to severe atopic dermatitis, has shown promise by inhibiting the signaling of IL-4 and IL-13 through blockade of the IL-4
receptor α (IL-4Rα) chain. However, despite its efficacy, Dupilumab is associated with adverse events such as ocular diseases,
erythema, and an increased risk of cutaneous T-cell lymphoma, likely due to its single-target approach and the saturation of IL-4Rα.

Phyto-N,
a botanical drug candidate, is being investigated as a potential alternative treatment for atopic dermatitis. This report summarizes
the preliminary findings from preclinical studies conducted on Phyto-N.

Preclinical
studies in animal models of atopic dermatitis have provided evidence of Phyto-N’s therapeutic potential effects. In a study using
6-8-week-old male BALB/c mice, (a specific strain of laboratory mice) with DNCB-induced acute atopic dermatitis (a chemical used to induce
a condition similar to atopic dermatitis in mice), oral administration of Phyto-N (3.3g/kg/d) for 21 days significantly improved skin
appearance, reduced skin lesion scores, and promoted overall health compared to control groups receiving either dexamethasone (0.585mg/kg/d,
a potent anti-inflammatory steroid) or physiological saline. These benefits were evident as early as the 8th day of treatment and continued
to improve until the end of the study period.

Histological
analyses showed that Phyto-N treatment reduced skin keratinization (excessive production of keratin, a protein in the outer layer of
skin), incomplete keratinization, and epidermal thickening in mice with acute atopic dermatitis (Figure 6 A, B). Additionally, Phyto-N
decreased the infiltration of inflammatory cells and mast cells (types of immune cells involved in allergic reactions) in the dermis
while promoting the growth of adnexal structures such as hair follicles and sebaceous glands, indicating its ability to restore skin
structure and function.

Importantly,
Phyto-N demonstrated potential anti-inflammatory properties by significantly reducing TNF-α levels (a protein involved in systemic
inflammation) in the skin tissue of atopic dermatitis mice (Figure 6C), suggesting its potential effects in modulating immune responses
and alleviating inflammation. These findings highlight Phyto-N’s potential approach to treating atopic dermatitis in animal model,
targeting not only the visible symptoms but also the underlying immunological mechanisms.

The
preclinical data demonstrating Phyto-N’s potential effects on improving skin appearance, reducing dermatitis scores, modulating
skin keratinization, and decreasing inflammation provide experimental evidence to support its therapeutic potential in atopic dermatitis.

These
studies were conducted in Yunnan Branch of the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences in China.
No adverse or severe adverse events were observed in the Phyto-N treated group during this study.

While
the multi-target, anti-inflammatory approach of Phyto-N observed in these preclinical studies appears promising, it is crucial to emphasize
that these are early-stage findings. There is no guarantee that these effects will translate effectively to human patients or that Phyto-N
will successfully navigate the drug development process. The path from these early results to a clinically approved drug is long, complex,
and uncertain, typically involving years of additional research, large-scale clinical trials, and rigorous regulatory reviews.

25

As
we continue to advance Phyto-N through clinical development, we remain cautiously optimistic about its potential while acknowledging
the significant challenges ahead. The goal of improving treatment options for patients with atopic dermatitis drives our commitment to
rigorous scientific investigation and adherence to regulatory standards.

Figure
6. Pharmacological Effects of Phyto-N on Atopic Dermatitis

Note:
(A) H&E staining of mice dorsal skin tissue (H&E, 200×); (B) Epidermal thickness of mice; (C) Determination of TNF-α
content in mice skin lesions. The result is represented by x̅±S. * indicates P<0.05; ** indicates P<0.01.

Virus
Infection: COVID-19

The
emergence of COVID-19 caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has inflicted unprecedented damage on the
global healthcare system, with over 770 million reported infections and 6.9 million deaths worldwide. While vaccines have been developed
to prevent the disease, there remains a critical need for effective therapeutic agents to treat COVID-19 patients and reduce the risk
of severe complications. Current treatment options primarily focus on symptomatic relief using palliative medications, which often come
with side effects such as gastrointestinal reactions and leukocyte damage. Given the high infectivity, rapid spread, and diverse sequelae
associated with COVID-19, preventive strategies are of paramount importance in controlling the pandemic.

26

Phyto-N,
a botanical drug candidate, is being investigated as a potential prophylaxis and treatment of COVID-19 in animal models. Phyto-N has
demonstrated in animal studies the ability to reduce viral loads in various organs and inhibit inflammation, thereby addressing the underlying
mechanisms of SARS-CoV-2 infection. We believe that by targeting the virus at its source and modulating the host immune response, Phyto-N
has the potential to prevent the development of severe COVID-19 and limit the spread of the virus in animal models.

The
potential prophylactic effects of Phyto-N were evaluated in a hamster model of SARS-CoV-2 infection. Hamsters are commonly used in COVID-19
research because they develop symptoms similar to humans when infected with SARS-CoV-2. Animal experiments were conducted at the Biosafety
level 3 facilities of Rutgers University in the United States have confirmed the favorable effects of Phyto-N treatment during
SARS-CoV2 infection. Hamsters were divided into two groups, no treatment group (n=10) and Phyto-N (260 mg/ animal) pre-treatment group
(oral gavage (n=10) for one week before infection). All the 20 hamsters were infected with SARS-CoV-2 (103 PFU) via intranasal
inoculation with 50µL inoculum prepared in sterile 1X PBS. PFU stands for Plaque-Forming Units, which is a measure of the number
of infectious virus particles. Intranasal inoculation means the virus was introduced into the hamsters’ nasal passages. Five hamsters
from each group were euthanized at 4 and 7-days post-infection (dpi), and tissues (lungs, liver, spleen, kidney, heart, and brain) were
collected for analysis. Viral load in tissues was determined by plaque assay. Histopathological analysis was performed on tissue sections
stained with hematoxylin and eosin (H&E). H&E staining allows researchers to visualize tissue structures and cellular changes
under a microscope. Immunohistochemistry and mRNA-fluorescent in situ hybridization (mRNA-FISH) were used to assess the expression of
immune cells and cytokines in the lungs. These techniques help identify specific types of cells and molecules in tissue samples. Gene
expression of cytokines and immune markers in various tissues was evaluated using quantitative real-time PCR (qPCR). qPCR measures the
amount of specific genes being expressed in a tissue.

Reduced
body weight loss: hamsters pre-treated with Phyto-N showed less body weight loss compared to untreated hamsters from day 1 to 7 post-infection.
The mean body weight loss was approximately 2% in the Phyto-N pre-treated group, compared to 5% in the untreated group at 2-4 dpi. This
suggests that Phyto-N may help maintain overall health during infection.

Lower
Viral load in tissues: a significant reduction in viral load was noted in the lungs of hamsters treated with Phyto-N before infection
at both 4- and 7-days post-infection (dpi) (Figure 7). This indicates that Phyto-N may help control the amount of virus in the lungs
throughout the infection.

Figure
7. Viral load in the lung at 4- and 7-days post-infection (dpi). The result is represented by x̅±SE. * indicates P<0.05;
** indicates P<0.01; *** indicates P<0.005. x̅±SE means the average plus or minus the standard error. P-values indicate
the statistical significance of the results, with lower values suggesting stronger evidence.

27

Viral
loads were also significantly lower in the liver, kidney, spleen, heart, and brain at 4 dpi in the Phyto-N pre-treated group (Figures
8). This result suggests that pre-treatment with Phyto-N before infection may have a beneficial role on the host to control the SARS-CoV-2
dissemination and to curb the viral load in the lungs as well as the extra pulmonary organs, particularly during early phase of infection
(e.g., 4dpi). This implies that Phyto-N may help prevent the virus from spreading to other organs beyond the lungs.

Figure
8. Viral load in the lung, liver and kidney at 4 dpi. The result is represented by x̅±SE. * indicates P<0.05; ** indicates
P<0.01; *** indicates P<0.005.

Reduced
histopathological changes (H&E staining): Phyto-N pre-treatment reduced inflammation, inflammatory cell infiltration, and bronchiolar
epithelial hyperplasia in hamster lungs at 4 and 7 dpi (Figure 9). This means that Phyto-N appeared to decrease the damage and abnormal
changes in lung tissue caused by the virus.

28

Figure
9. H&E-stained sections of the lungs from untreated and Phyto-N treated hamsters at 4 and 7 dpi.

The
severity of pathologic manifestations, such as thrombotic lesions and tissue degeneration, was reduced in the liver and kidney of Phyto-N
pre-treated hamsters, while a slight reduction in hemorrhagic response was observed in the brain at 4 dpi. This suggests that Phyto-N
may help protect other organs from damage caused by the virus or the body’s response to it.

Modulation
of immune cell infiltration (Immunohistochemistry): Increased infiltration of CD3 positive T cells and decreased infiltration of activated
macrophages (IBA1 positive cells) were observed in the lungs of Phyto-N pre-treated hamsters compared to untreated infected hamsters
(Figures 10 & 11), indicating a potential immunomodulatory effect of Phyto-N. This means Phyto-N may help balance the immune response,
potentially reducing harmful inflammation while maintaining protective immunity.

29

Figure
10. Immunohistochemistry of lung with or without Phyto-N treatment

Figure
11. Immune cells in SARS-CoV-2 infected Hamster Lungs with or without Phyto-N treatment measured by immunofluorescence. The result is
represented by x̅±SE. * indicates P<0.05; ** indicates P<0.01; *** indicates P<0.005.

30

Regulation
of cytokine and immune marker gene expression:

Phyto-N
pre-treatment upregulated the expression of IFN-γ, IL-1β, TNF-α, CCL2, IL-10, and IL-4 in the lungs, spleen, liver,
kidney, brain, and heart of hamsters, while decreasing the expression of IL-6, CRP, and TMPRSS in various organs, further suggesting
its immune-modulatory properties. These changes in gene expression suggest that Phyto-N may help regulate the immune response, potentially
reducing harmful inflammation while maintaining protective immunity.

Pre-treatment
with Phyto-N before SARS-CoV-2 infection was observed to have protective effects in a hamster model. Pre-treatment with Phyto-N was associated
with reduced replicative viral burden at the site of infection (lungs) and viral dissemination, as noted by reduction in viral load in
extrapulmonary organs, such as liver, kidney, spleen, heart and brain. The improved viral load clearance in Phyto-N pre-treated hamster
appeared to be more pronounced during early stages (i.e., 4dpi) of SARS-CoV-2 infection. Therefore, it can be hypothesized that administration
of Phyto-N acts as an immune-booster and prepares the host to defend the viral replication in the internal organs. The reduced viral
load in organs might also have a positive association with the improvement in body weight loss in the Phyto-N pretreated hamsters, compared
to untreated animals. The histopathologic analysis of internal organs of SARS-CoV-2 infected hamsters also suggested signs of immune
modulation, marked by a mild to moderate level of reduction in disease severity in the Phyto-N pretreated animals, compared to the untreated
animals.

Phyto-N
pre-treatment reduced body weight loss, viral loads in the lungs and extrapulmonary organs, and the severity of histopathological changes
in the lungs, liver, and kidney. The observed protective effects of Phyto-N might be associated with increased infiltration of T cells,
decreased infiltration of activated macrophages in the lungs, and modulation of cytokine and immune marker expression in various organs.
No adverse or severe adverse events were observed in the Phyto-N treated group during this study.

In
conclusion, the preclinical studies suggest that Phyto-N may be a promising prophylactic agent against SARS-CoV-2 infection in this animal
model, with the potential to reduce viral load, mitigate inflammatory responses, and prevent severe COVID-19 complications. While the
preclinical data on Phyto-N in the context of COVID-19 prevention presents intriguing possibilities, it is important to note that results
from animal studies may not directly translate to human outcomes. The path from these early results to a clinically approved drug is
long, complex, and uncertain, typically involving years of additional research, large-scale clinical trials, and rigorous regulatory
reviews. As we continue to advance Phyto-N through clinical development, we remain cautiously optimistic about its potential while acknowledging
the significant challenges ahead. Extensive clinical research is needed to establish its safety and efficacy in humans. We look forward
to conducting these necessary studies and reporting on the results as they become available.

Diabetes

Diabetes,
a chronic metabolic disorder characterized by elevated blood glucose levels, affects millions of people worldwide. While current treatments,
such as insulin and metformin, have been lifesaving for many patients, there remains a significant unmet need for more effective and
comprehensive therapies that can address the complex pathophysiology of diabetes and its associated complications. Phyto-N, a botanical
drug candidate, has demonstrated therapeutic potential in animal studies, suggesting potential for further investigation in the management
of diabetes.

The
high-sugar and high-fat diet combined with low-dose intraperitoneal injection of streptozotocin (STZ), a chemical that damages insulin-producing
cells, was used to induce a type 2 diabetes mellitus (T2DM) rat model. According to the groups, gastric lavage was administered continuously
for 12 weeks with Phyto-N (1.8g/kg/d), the positive control drug metformin (0.2g/kg/d, a common diabetes medication), or a placebo with
equivalent physiological saline.

After
administering Phyto-N, the body weight of diabetic rats increased, which can be a positive sign in diabetes management. Fasting blood
glucose concentration and glycated hemoglobin (HbA1c) concentration decreased (Figure 12). HbA1c is a measure of average blood sugar
levels. Phyto-N also reduced fasting serum insulin concentration, with its effect comparable to the first-line hypoglycemic drug metformin
in animal studies. Oral glucose tolerance test (OGTT) analysis measures how well the body
processes glucose. Phyto-N decreased the area under the curve (AUC) of OGTT curve, indicating improved glucose processing. The peak blood
glucose level was significantly lower than that in the metformin drug group. Insulin tolerance test (ITT) analysis measures how sensitive
the body is to insulin. Phyto-N decreased the AUC of ITT curve, and the blood sugar levels at all time points were significantly lower
than that in the metformin drug group (Figure 12).

31

Figure
12. Pharmacological Effects of Phyto-N on Diabetes

Note:
(A) Body weight of rats; (B) Fasting blood glucose concentration of rats; (C) HbA1c concentration of rats; (D) Insulin concentration
of rats; (E) OGTT AUC of rats; (F) ITT AUC of rats. The result is represented by x̅±S. * indicates P<0.05, ** indicates
P<0.01.

32

Figure
13. Pharmacological Effects of Phyto-N on Diabetes

Note:
(A) Homeostatic model assessment for insulin resistance (HOMA-IR) and homeostatic model assessment
for insulin sensitivity (HOMA-IS) of rats; (B) TG, TC, HDLC and LDLC concentration of rats. The result is represented by x̅±S.
* indicates P<0.05, ** indicates P<0.01.

33

Figure
14. Pharmacological Effects of Phyto-N on Diabetes

Note:
(A) ALT and AST concentration of rats; (B) Blood urea nitrogen (UREA) and creatinine (CREA) concentration of rats. The result is represented
by x̅±S. * indicates P<0.05, ** indicates P<0.01.

Additionally,
Phyto-N reduced the insulin resistance index HOMA-IR and increased the insulin sensitivity index HOMA-IS in diabetic rats (Figure 13).
These are important measures of how well the body responds to insulin. Phyto-N improved lipid profile by reducing levels of triglycerides
(TG), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C), while increasing high-density lipoprotein cholesterol
(HDL-C).

Beyond
its effects on glycemic control, Phyto-N demonstrated benefits in protecting the structure and function of key organs affected by diabetes.
Histological analyses revealed that Phyto-N restored pancreatic tissue morphology, improved liver tissue structure, and reduced markers
of kidney dysfunction, such as UREA and CREA levels (Figure 14). These findings suggest that Phyto-N may have the potential to prevent
or reverse diabetes-related complications, such as pancreatic beta-cell dysfunction, nonalcoholic fatty liver disease, and diabetic nephropathy.

These
studies were conducted in Yunnan Branch of the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences in China.
No adverse or severe adverse events were observed in the Phyto-N treated group during this study.

The
data from our preclinical studies suggests that Phyto-N may have the potential to influence glycemic control, insulin sensitivity, and
organ protection in animal models of diabetes. The observed multifaceted effects of Phyto-N in these preclinical studies present an interesting
avenue for future investigation in diabetes treatment. If these effects are confirmed in human studies, Phyto-N could potentially offer
a new approach for patients seeking improved long-term outcomes and quality of life. However, it’s important to note that many
promising preclinical candidates do not successfully translate to effective human therapies.

34

We
will thoroughly evaluate Phyto-N’s safety and efficacy in humans. Our goal is to explore whether Phyto-N could potentially address
some of the unmet needs in diabetes care.

Prevention
and Treatment of Nonalcoholic Fatty Liver Disease

Nonalcoholic
fatty liver disease (NAFLD) is a chronic liver condition characterized by excessive fat accumulation in the liver, often leading to inflammation,
fibrosis, and cirrhosis. Nonalcoholic fatty liver disease (NASH) is an inflammatory subtype of NAFLD, characterized by hepatic steatosis
and evidence of hepatocellular injury (ballooning) and inflammation, with or without fibrosis. Despite the recent approval of Rezdiffra
(resmetirom) by the US FDA in March 2024 as the first drug for the treatment of NASH, there remains a significant unmet need for safe
and effective therapies that can address the underlying pathophysiology of NAFLD and prevent its progression.

Rezdiffra,
a thyroid hormone receptor-β (THR-β) agonist, aims to target the impaired THR-β activity in the liver, which contributes
to decreased mitochondrial function, reduced β-oxidation of fatty acids, and subsequent inflammation and fibrosis. However, Rezdiffra
is associated with common side effects such as diarrhea and nausea, and its label includes a safety warning for physicians to monitor
liver enzymes and liver-related adverse events. Moreover, the FDA recommends limiting the use of statins in patients receiving Rezdiffra
due to potential drug interactions. Phyto-N, a botanical drug, offers a promising alternative approach to the prevention and treatment
of NAFLD.

Preclinical
studies in animal models of NAFLD evaluated the therapeutic potential of Phyto-N in preventing and treating this chronic liver condition.

Nonalcoholic
Fatty Liver Disease (Prevention)

Nonalcoholic
Fatty Liver Disease (NAFLD) is a condition where excess fat accumulates in the liver of people who drink little or no alcohol. To study
the potential preventive effects of Phyto-N on NAFLD, 40 male SPF C57BL/6 mice, a specific strain of laboratory mice, were treated with
Gubra-Amylin NASH (GAN) feed for 22 consecutive weeks to induce NAFLD. From the 4th week onwards until the end of modeling, the Phyto-N
group was administered Phyto-N (3.9g/kg/d) via gastric lavage, the Positive group was administered metformin (0.221g/kg/d), a common
diabetes medication, via gastric lavage, and the other groups were administered equivalent physiological saline. Insulin resistance is
an important factor in the occurrence and development of NAFLD. After insulin resistance occurs, glucose in the blood is converted into
triglycerides stored in the liver, which then leads to liver damage and inflammation. We first observed changes in body weight and blood
sugar trends in mice and found that after Phyto-N intervention, both body weight and blood sugar decreased compared to model mice. Results
from OGTT and ITT analyses suggested that Phyto-N improved glucose tolerance and insulin sensitivity in mice fed a high-fat diet (Figure
15). After Phyto-N intervention, the liver color of mice returned to a healthy deep red, the greasy feeling disappeared, and the weight
and index of the liver decreased.

35

Figure
15. Preventive Effect of Phyto-N on Nonalcoholic Fatty Liver Disease

Note:
(A) Body weight and (B) blood sugar trends in mice; AUC of OGTT (C) and ITT (D) in mice; (E) Liver weight and (F) liver index of mice.
The result is represented by x̅±S. * indicates P<0.05, ** indicates P<0.01.

H&E
staining of the liver tissue showed a significant reduction in the number of white vacuoles in mice given Phyto-N, indicating inhibition
of liver steatosis, and the volume of liver cells decreased, with occasional vesicular fat vacuoles and no inflammatory reaction observed
(Figure 16). Oil red O staining of the liver showed that Phyto-N could reduce the number and volume of red lipid droplets accumulated
in liver cells. Serum index analysis showed that Phyto-N improved blood lipid levels and liver function in mice. Inflammatory factors
IL-1β, IL-6, and TNF-α in the liver were also significantly reduced by Phyto-N, suggesting potential anti-inflammatory effects.

36

Figure
16. Preventive Effect of Phyto-N on Nonalcoholic Fatty Liver Disease

Note:
(A) Liver tissue staining slice observation (H&E, 200x), black arrow indicates fatty vacuoles, blue arrow indicates balloon-like
lesions; (B) Liver tissue staining slice observation (oil red O, 200×); (C) Serum AST, ALT, and LDL-C. The result is represented
by x̅±S. * indicates P<0.05, ** indicates P<0.01.

These
findings suggest that Phyto-N can effectively prevent the development and progression of NAFLD potentially by modulating glucose and
lipid metabolism, enhancing insulin sensitivity, reducing hepatic steatosis and inflammation, and improving overall liver function in
this animal model.

Nonalcoholic
Fatty Liver Disease (Treatment)

Building
on the preventive effect of Phyto-N on NAFLD in animal model, we further investigated its therapeutic effect on NAFLD. Forty male SPF
C57BL/6 mice were induced with Gubra-Amylin NASH (GAN) feed for 22 consecutive weeks, and drug intervention began in the 22nd week while
continuing to feed them with GAN control feed. For 12 weeks continuously, the Phyto-N group was administered Phyto-N (3.9g/kg/d) via
gastric lavage, the Positive group was administered metformin (0.221g/kg/d) via gastric lavage, and the other groups were administered
equivalent physiological saline. The main research results obtained are as follows: Phyto-N intervention reduced the body weight and
blood sugar of NAFLD mice (Figure 17).

37

Figure
17. Therapeutic Effect of Phyto-N on Nonalcoholic Fatty Liver Disease

Note:
Body weight and blood sugar trends in mice. The result is represented by x̅±S. * indicates P<0.05, ** indicates P<0.01.

Phyto-N
intervention could significantly reduce AST and ALT enzymes that indicate liver damage when elevated, improving liver damage in mice
induced by a high-fat diet (Figure 18).

38

Figure
18. Therapeutic Effect of Phyto-N on Nonalcoholic Fatty Liver Disease

Note:
(A) Liver tissue staining slice observation (H&E, 200x), black arrow indicates fatty vacuoles; blue arrow indicates balloon-like
lesions; (B) Serum AST and ALT. The result is represented by x̅±S. * indicates P<0.05, ** indicates P<0.01.

These
results demonstrate that Phyto-N, even when the high-fat diet was continued, can effectively treat established NAFLD by reducing hepatic
steatosis, improving liver function, and attenuating inflammation, even in the presence of ongoing dietary challenges in animal model.

39

In
conclusion, preclinical studies suggest potential benefits of Phyto-N for the prevention and treatment of NAFLD. By affecting multiple
pathways potentially involved in the pathogenesis of NAFLD, including glucose and lipid metabolism, insulin resistance, and inflammation,
Phyto-N may offer an alternative approach to managing this complex liver disorder. However, further research is needed to confirm these
initial findings.

These
studies were conducted in Yunnan Branch of the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences in China.
While no adverse or severe adverse events were observed in the Phyto-N treated group during this preclinical study, it’s important
to note that results in animal studies don’t always translate directly to humans.

As
Curanex advances Phyto-N through clinical development, we hope that this botanical drug candidate may provide an alternative approach
to current NAFLD therapies, potentially addressing some limitations of single-target approaches. With its observed anti-inflammatory
and hepatoprotective properties in preclinical studies and potential for disease modification, Phyto-N could represent a new direction
in the management of NAFLD and its associated comorbidities. However, clinical trials are necessary to establish its efficacy and safety
in humans.

Gout

Gout,
a common form of inflammatory arthritis, is caused by the deposition of monosodium urate crystals in joints and surrounding tissues due
to hyperuricemia. Current treatments for gout, such as Febuxostat, aim to reduce serum uric acid levels by inhibiting xanthine oxidase,
the enzyme responsible for uric acid synthesis. However, despite its efficacy in lowering uric acid levels, Febuxostat carries a black
box warning from the FDA, indicating an increased risk of cardiovascular death in gout patients. The pathogenesis of gout involves the
activation of inflammatory pathways, with urate crystals triggering the secretion of key inflammatory mediators such as TNF-α,
Caspase-1, IL-6, IL-18, and IL-1β at the site of inflammation. These mediators recruit neutrophils and perpetuate the inflammatory
cascade, leading to the clinical manifestations of gouty arthritis and nephropathy. The NLRP3 inflammasome, a critical component of the
innate immune system, plays a pivotal role in the progression of gout-related diseases.

Phyto-N,
a botanical drug candidate, has shown potential in preclinical studies as an alternative approach to gout treatment. These studies suggest
that Phyto-N may reduce the activation of the NLRP3 inflammasome through ubiquitination modification and other pathways, thereby decreasing
the secretion of downstream inflammatory factors.

Gouty
Nephritis

Gouty
nephritis is characterized by hyperuricemia accompanied by renal damage. Due to disturbances in purine metabolism in the body, uric acid
is either overproduced or excreted insufficiently, leading to prolonged saturation of uric acid in the body. Subsequently, the deposition
of urate crystals in the kidneys causes damage, leading to gouty nephritis.

Uric
acid (UA), creatinine (Cr), blood urea nitrogen (BUN) are important indicators for evaluating renal function. Higher levels of these
substances in the blood typically indicate impaired kidney function. Xanthine oxidase (XOD) and adenosine deaminase (ADA) are key enzymes
in the process of uric acid production, while TNF-α, Caspase-1, IL-6, IL-18, IL-1β, and NLRP3 are important inflammatory factors
in the body. These inflammatory factors are proteins that promote inflammation and are often elevated in various diseases.

Animal
experiments have suggested the potential good therapeutic effect of Phyto-N on gouty nephritis. 60 SPF-grade (Specific Pathogen Free,
meaning the animals are free from certain pathogens) male KM mice were administered an oral suspension of adenine (100mg/kg) and potassium
oxonate (500mg/kg) to induce hyperuricemia and renal damage. The animals were then divided into three groups, receiving either Phyto-N
(2.6g/kg/d), the positive control drug nifedipine (5.2mg/kg/d), or physiological saline for 3 weeks via gastric lavage.

The
results demonstrated that Phyto-N significantly reduced serum levels of uric acid (UA), creatinine (Cr), blood urea nitrogen (BUN), xanthine
oxidase (XOD), and adenosine deaminase (ADA), which are key indicators of renal function and uric acid metabolism (Figure 19). Histological
analyses revealed that Phyto-N treatment improved renal fibrosis (scarring of kidney tissue), glomerular atrophy (shrinkage of kidney
filtering units), and tubular dilatation (widening of kidney tubules) caused by the adenine and potassium oxonate administration.

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Figure
19. Pharmacological Effects of Phyto-N on Gouty Nephritis

Note:
(A) UA, Cr and BUN in mice serum; (B) XOD, ADA in mouse liver and SOD in mice kidney. The result is represented by x̅±S.
x̅±S means the average plus or minus the standard deviation, a measure of variability in the data. * indicates P<0.05;
** indicates P<0.01. P-values indicate the statistical significance of the results, with lower values suggesting stronger evidence.

Furthermore,
Phyto-N increased the activity of superoxide dismutase (SOD) in the kidneys, an important antioxidant enzyme which helps protect cells
from damage caused by harmful molecules, and significantly decreased the levels of inflammatory factors TNF-α, Caspase-1, IL-6,
IL-18, IL-1β, and NLRP3 (Figure 20). These findings suggest that Phyto-N may exert its therapeutic effects by modulating oxidative
stress and inflammation in gouty nephritis animal model.

Figure
20. Pharmacological Effects of Phyto-N on Gouty Nephritis

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Inflammatory
factors in mice kidney. The result is represented by x̅±S. * indicates P<0.05; ** indicates P<0.01.

Notably,
during the experiment, Phyto-N also demonstrated a positive impact on the body weight and food intake of the gouty nephritis mice, suggesting
its potential to improve overall health and quality of life in the context of this disease. In summary, the preclinical data suggested
that Phyto-N can significantly alleviate inflammation in gouty nephritis and effectively reverse the symptoms of this condition by targeting
the underlying pathogenic mechanisms in gout animal model.

Gouty
Arthritis

Gouty
arthritis, another manifestation of gout, occurs when urate crystals deposit in the joints due to prolonged hyperuricemia, leading to
intense pain, swelling, and inflammation. This condition can significantly impact patients’ mobility and quality of life. To evaluate
the potential positive effects of Phyto-N on treating gouty arthritis, a preclinical study was conducted using SPF-grade male SD rats.
The animals were divided into three groups, receiving either Phyto-N (1.8g/kg/d), the positive control drug colchicine (0.3mg/kg/d),
or physiological saline via gastric lavage for 7 days. On the seventh day, gouty arthritis was induced by injecting a 0.7% acetic acid
solution intraperitoneally, with the dose adjusted according to the rats’ body weight. The analgesic effect of Phyto-N was assessed
by measuring the number of twists after the acetic acid injection and the activity time in an open field experiment (Figure 21 A,B).
These measurements are used to evaluate pain and discomfort in animal models. The results showed that Phyto-N significantly reduced pain-related
behavior, demonstrating its potent analgesic properties. Moreover, following the intra-articular injection of urate crystals injection
into the joint, rats in the Phyto-N group experienced a transient decrease in food intake and body weight, followed by a rapid rebound
the next day. The rebound rate in the Phyto-N group was superior to that observed in the gouty arthritis model rats, suggesting that
Phyto-N may promote recovery and mitigate the systemic effects of acute inflammation.

The
anti-inflammatory effects of Phyto-N were further evaluated by measuring joint swelling at various time points (2h, 4h, 6h, 8h, 10h,
12h, and 24h) after urate crystal injection. Phyto-N treatment significantly reduced joint swelling compared to the control group, indicating
potential effects on local inflammation in this animal model (Figure 21C). To assess potential effects of Phyto-N on liver and kidney
function, serum levels of uric acid, creatinine (CREA), urea, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were
measured in the animal model. ALT and AST are enzymes that can indicate liver damage when elevated in the blood. All five indicators
decreased following Phyto-N administration, suggesting no observed adverse effects on the liver or kidneys function in this animal model
(Figure 22).

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Figure
21. Pharmacological Effects of Phyto-N on Gouty Arthritis

Note:
(A) rats twist counts; (B) Rats activity time; (C) Swelling index of rats’ ankle joints at various time points; The result is represented
by x̅±S. * indicates P<0.05; ** indicates P<0.01.

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Figure
22. Pharmacological Effects of Phyto-N on Serum Biochemical Parameters in Rats Gouty Arthritis

Note:
The result is represented by x̅±S. * indicates P<0.05; ** indicates P<0.01.

These
studies were conducted in Yunnan Branch of the Institute of Medicinal Plant Development, Chinese Academy of Medical Sciences in China.
In conclusion, the experimental results suggest analgesic and anti-inflammatory effects of Phyto-N in preclinical models of gouty arthritis,
with no observed any apparent side effects on the liver or kidneys in these studies. These findings suggest the promising therapeutic
potential of Phyto-N in the management of this debilitating condition. As Curanex advances Phyto-N through clinical development for the
treatment of gout, we believe that this botanical drug candidate may offer an alternative to current therapies.

By
potentially affecting the underlying inflammatory pathways and reducing the activation of the NLRP3 inflammasome, Phyto-N has the potential
to provide relief from both gouty nephritis and arthritis. The preclinical data, showing Phyto-N’s ability in animal models to
reduce serum uric acid levels, alleviate inflammation, improve renal function, and mitigate pain and joint swelling, provide a basis
for further clinical investigation. As we progress Phyto-N through clinical trials, we aim to develop a potential treatment option for
gout patients worldwide, addressing the need for additional therapies in this field. However, it is important to note that results from
preclinical studies may not necessarily translate to human patients, and the safety and efficacy of Phyto-N in humans can only be determined
through rigorous clinical trials.

Competition

The
pharmaceutical industry is characterized by rapidly advancing technologies and intense competition. While we believe that our knowledge,
experience, and scientific resources provide us with competitive advantages, we face potential competition from many different sources,
including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions and governmental agencies
and public and private research institutions. Any product candidates for which we complete clinical development successfully and for
which we receive marketing approval may compete with existing therapies and new therapies that may become available in the future.

Many
of our competitors have far greater marketing and research capabilities than us, such as Regeneron/Sanofi, Pfizer, LEO Pharma, Eli Lilly,
Galderma, AbbVie, and Novartis, among others (Source: Market Data Forecast, 2023). These companies are focused on developing novel biologics,
expanding their product portfolios, and investing in R&D to maintain their market position.

We
also face potential competition from academic institutions, government agencies and private and public research institutions, among others,
which may in the future develop products to treat those diseases that we currently or, in the future, seek to treat. The current market
for treatments that assist in novel therapeutics for major unmet medical needs, is highly unknown. Our commercial opportunity would be
reduced significantly if our competitors developed and commercialize products that are safer, more effective, more convenient, have fewer
side effects or are less expensive than our product candidates.

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Government
Regulations

The
development, manufacturing, and commercialization of our botanical drug product candidates are subject to extensive regulation by authorities
in the United States and other countries. In the United States, the FDA is the primary regulatory agency overseeing the approval and
marketing of new drugs. FDA imposes substantial requirements upon the research, development, preclinical and clinical testing, labeling,
manufacture, quality control, storage, approval, advertising, promotion, marketing, distribution, and export of pharmaceutical products,
including biologics, as well as significant reporting and record-keeping obligations. State governments may also impose obligations in
these areas.

In
the United States, pharmaceutical products are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act, or FDCA, and other
laws, including in the case of biologics, the Public Health Service Act. We believe, but cannot be certain, that our products will be
regulated as biologics and drugs by the FDA. The process required by the FDA before biologics or drugs may be marketed in the United
States generally involves the following:

●
preclinical
laboratory evaluations, including formulation and stability testing, and animal tests performed under the FDA’s Good Laboratory
Practices regulations to assess potential safety and effectiveness;

●
submission
and approval of an IND, including results of preclinical tests and protocols for clinical tests, which must become effective before
clinical trials may begin in the United States;

●
obtaining
approval of Institutional Review Boards to administer the products to human subjects in clinical trials;

●
adequate
and well-controlled human clinical trials to establish the safety and efficacy of the product for the product’s intended use;

●
development
of manufacturing processes which conform to FDA current Good Manufacturing Practices, or cGMPs, as confirmed by FDA inspection;

●
submission
of preclinical and clinical test results, and chemistry, manufacture and control information on the product to the FDA in a New Drug
Approval Application, or NDA; and

●
FDA
review and approval of an NDA, prior to any commercial sale or shipment of a product.

The
testing and approval process requires substantial time, effort, and financial resources, and we cannot be certain that any approval will
be granted on a timely basis, if at all.

The
results of the preclinical tests, together with initial specified manufacturing information, the proposed clinical trial protocol, and
information about the participating investigators, are submitted to the FDA as part of an IND, which must be approved before we may begin
human clinical trials. Additionally, an independent Institutional Review Board at each clinical trial site proposing to conduct the clinical
trials must review and approve each study protocol and oversee conduct of the trial. An IND becomes effective 30 days after receipt by
the FDA, unless the FDA, within the 30-day period, raises concerns or questions about the conduct of the trials as outlined in the IND
and imposes a clinical hold. If the FDA imposes a clinical hold, the IND sponsor must resolve the FDA’s concerns before clinical
trials can begin. Pre-clinical tests and studies can take several years to complete, and there is no guarantee that an IND we submit
based on such tests and studies will become effective within any specific time period, if at all.

Human
clinical trials are typically conducted in three sequential phases that may overlap:

●
Phase
I: The drug is initially introduced into healthy human subjects or patients and tested for safety and dosage tolerance. Absorption,
metabolism, distribution, and excretion testing is generally performed at this stage.

●
Phase
II: The drug is studied in controlled, exploratory therapeutic trials in a limited number of subjects with the disease or medical
condition for which the new drug is intended to be used in order to identify possible adverse effects and safety risks, to determine
the preliminary or potential efficacy of the product for specific targeted diseases or medical conditions, and to determine dosage
tolerance and the optimal effective dose.

●
Phase
III: When Phase II studies demonstrate that a specific dosage range of the drug is likely to be effective and the drug has an
acceptable safety profile, controlled, large-scale therapeutic Phase III trials are undertaken at multiple study sites to demonstrate
clinical efficacy and to further test for safety in an expanded patient population.

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Results
of preclinical studies and trials, as well as detailed information about the manufacturing process, quality control methods, and product
composition, among other things, are submitted to the FDA as part of an NDA seeking approval to market and commercially distribute the
product on the basis of a determination that the product is safe and effective for its intended use. NDAs are used for products that
are regulated as drugs, such as synthetic chemicals. Before approving an NDA, the FDA will inspect the facilities at which the product
is manufactured and will not approve the product unless cGMP compliance is satisfactory. If applicable regulatory criteria are not satisfied,
the FDA may deny the NDA or require additional testing or information. As a condition of approval, the FDA also may require post-marketing
testing or surveillance to monitor the product’s safety or efficacy. Even after an NDA is approved, the FDA may impose additional
obligations or restrictions (such as labeling changes), or even suspend or withdraw a product approval on the basis of data that arise
after the product reaches the market, or if compliance with regulatory standards is not maintained. We cannot be certain that any NDA
we submit will be approved by the FDA on a timely basis, if at all. Also, any such approval may limit the indicated uses for which the
product may be marketed. Any refusal to approve, delay in approval, suspension or withdrawal of approval, or restrictions on indicated
uses could have a material adverse impact on our business prospects.

Satisfaction
of FDA requirements typically takes several years. The actual time required varies substantially, based upon the type, complexity, and
novelty of the pharmaceutical product, among other things. Government regulation imposes costly and time-consuming requirements and restrictions
throughout the product life cycle and may delay product marketing for a considerable period of time, limit product marketing, or prevent
marketing altogether. Success in pre-clinical or early-stage clinical trials does not assure success in later stage clinical trials.
Data obtained from preclinical and clinical activities is not always conclusive and may be susceptible to varying interpretations that
could delay, limit, or prevent marketing approval. Even if a product receives marketing approval, the approval is limited to specific
clinical indications. Further, even after marketing approval is obtained, the discovery of previously unknown problems with a product
may result in restrictions on the product or even complete withdrawal of the product from the market.

As
a company focused on botanical drug development, we are committed to complying with all applicable laws, regulations, and guidance set
forth by the FDA and other relevant regulatory bodies, although it is costly and time-consuming. We recognize that the path to approval
for botanical drugs may differ from that of traditional small molecules or biologics, and we will work closely with the FDA to ensure
that our development programs meet the necessary requirements for safety, efficacy, and quality.

Botanical
Drug Development Considerations

The
FDA has established a specific framework for the development and review of botanical drugs. Within the FDA, the Center for Drug Evaluation
and Research (CDER) is responsible for reviewing botanical drug applications. Specifically, the Office of New Drugs (OND), the Office
of Nonprescription Drugs, and the Division of Clinical Evaluation and Pharmacology/Toxicology are involved in this process.

A
key component of this framework is the Botanical Review Team (BRT), a specialized group within CDER that provides expertise in evaluating
the unique challenges and scientific considerations involved in the development and regulation of botanical drugs. The BRT works to ensure
that botanical drugs meet the same standards of quality, safety, and efficacy as other drug products.

The
FDA has published a comprehensive guide, “Botanical Drug Development Guidance for Industry,” which outlines the process and
requirements for developing botanical drugs. This guidance acknowledges the unique characteristics of botanical drugs, such as their
complex nature and potential history of traditional use, while maintaining rigorous standards for safety and efficacy.

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While
the fundamental requirements for approval remain the same as for conventional drugs, the FDA’s approach recognizes the distinctive
aspects of botanical drugs. Each botanical drug candidate is evaluated on a case-by-case basis, considering its specific properties and
the totality of evidence supporting its use.

Unique
challenges in botanical drug development include:

1.
Complexity
of botanical extracts: Unlike single-molecule drugs, botanical drugs often contain multiple active compounds, making it challenging
to identify and characterize all active ingredients.

2.
Standardization
and quality control: Ensuring consistent composition and potency of botanical drugs can be challenging due to natural variations
in plant materials.

3.
Pharmacokinetics
and drug interactions: The complex nature of botanical extracts can make it difficult to predict how they will be absorbed, metabolized,
and excreted by the body, as well as potential interactions with other drugs.

4.
Intellectual
property protection: Patenting botanical drugs can be more challenging than single-molecule drugs, potentially affecting market exclusivity.

5.
Manufacturing
challenges: Scaling up production while maintaining consistency and quality can be more complex for botanical drugs than for synthetic
drugs.

These
unique aspects of botanical drug development may result in a more complex and potentially longer regulatory review process, additional
costs, and a higher risk of regulatory delays or rejections compared to conventional drug development.

Our
Regulatory Strategy for Phyto-N

Considering
these unique challenges for botanical drugs, our regulatory strategy for Phyto-N is tailored to address these specific issues while meeting
FDA requirements. Key components of our regulatory approach include:

1.
Engaging early and often with the FDA: We will proactively seek guidance from the FDA on the most appropriate development path
for Phyto-N, including the design of preclinical studies, clinical trials, and CMC (Chemistry, Manufacturing, and Controls) requirements.
By maintaining an open and transparent dialogue with the agency, we aim to minimize regulatory risks and optimize our chances of success.

2.
Leveraging existing human experience: Phyto-N has a long history of human use as an herbal medicine, with thousands of patients
having used it over the past 30 years. We will work with the FDA to determine how this real-world evidence can be incorporated into our
development program to potentially streamline the path to approval.

3.
Conducting rigorous preclinical and clinical studies: While Phyto-N has a long history of human use, we recognize the need to
generate robust scientific evidence to support its efficacy and safety in the target indications. We will conduct well-designed, adequately
powered, and properly controlled studies to meet the evidentiary standards required by the FDA and other regulatory agencies.

4.
Implementing cGMP compliance: We will ensure that our manufacturing processes and facilities for Phyto-N adhere to current Good
Manufacturing Practices (cGMP) as required by the FDA. This includes implementing strict quality control measures, validating analytical
methods, and maintaining comprehensive documentation to ensure the consistency, purity, and potency of our botanical drug product.

5.
Navigating accelerated approval pathways: Where appropriate, we will explore accelerated approval pathways available for botanical
drugs, such as the Fast Track and Breakthrough Therapy designations, which can expedite the development and review process for promising
therapies that address serious or life-threatening conditions with high unmet medical needs.

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6.
Protecting intellectual property: We will build a strong patent portfolio around Phyto-N and its therapeutic uses, to ensure market
exclusivity and protect our investment in research and development. We will also safeguard our proprietary knowledge and trade secrets
related to the sourcing, processing, and formulation of our botanical drug product.

7.
Maintaining ethical standards: Throughout our development and commercialization activities, we will adhere to the highest ethical
standards and ensure the protection of patient rights, data privacy, and scientific integrity. We will conduct our clinical trials in
accordance with Good Clinical Practices (GCP) and obtain proper informed consent from all participants.

Our
activities also may be subject to state laws and regulations that affect our ability to develop and sell our products. We are also subject
to numerous federal, state, and local laws relating to such matters as safe working conditions, clinical, laboratory, and manufacturing
practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances. We may incur
significant costs to comply with such laws and regulations now or in the future, and the failure to comply may have a material adverse
impact on our business prospects. In addition to complying with FDA regulations, we may be subject to varied regulations in other countries,
governing clinical trials, manufacturing, product registration, approval, and pharmaceutical sales. These regulations may differ from
those of the FDA, and we must obtain separate approvals from the regulatory authorities of each country prior to commencing product marketing
in those countries.

The
approval process and requirements vary from country to country, and the time required for approval may be longer or shorter than that
required by the FDA. In some countries, regulatory authorities also establish pricing and reimbursement criteria, which can impact the
commercial viability of our products.

As
part of our global regulatory strategy, we will:

1.
Engage with foreign regulatory agencies early in the development process to understand their specific requirements and expectations for
botanical drug approval.

2.
Design our clinical trials to meet the standards of both the FDA and foreign regulatory agencies, to minimize duplication of efforts
and streamline the global development process.

3.
Seek out experienced partners and consultants with expertise in navigating the regulatory landscapes of our target markets, to ensure
compliance and maximize our chances of success.

4.
Monitor evolving regulations and guidance in key markets, and adapt our strategies as needed to stay compliant and competitive.

In
China, where Phyto-N has been studied as an herbal medicine, we have accumulated data from hundreds to thousands of patients over thirty
years, under the supervision of licensed traditional Chinese medicine practitioners. According to Chinese law, these practitioners can
prescribe herbal medications to treat diseases based on their experience and expertise. The clinical observations suggest that Phyto-N
may have potential therapeutic effects in various diseases.

The
real-world evidence collected in China may provide valuable insight into the potential of Phyto-N as a therapeutic agent. These reports
have inspired us to pursue the rigorous scientific research and clinical development necessary to evaluate Phyto-N’s safety and
efficacy and seek FDA approval as a botanical drug. As we move forward with our global development plans, we will conduct preclinical
and clinical studies under the regulations of the FDA and other relevant authorities to generate the evidence needed to support the approval
of Phyto-N for specific indications. We will also work closely with these regulatory agencies to ensure that our research, manufacturing,
and marketing practices comply with all relevant laws and regulations in each country where we seek to commercialize Phyto-N.

Employees

As
of March 30, 2026, we had six (6) full-time employees. None of our employees are represented by labor unions or covered by collective
bargaining agreements.

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