OTC: CNBX

On September 30, 2010, we increased our authorized
capital to 900 million shares of common stock (par value $0.0001) and 100 million shares of preferred stock (par value $0.0001) and effected
a 20-for-1 reverse split of our issued and outstanding common stock. As a result of the reverse split, our issued and outstanding common
stock was reduced from 13,604,000 shares to 680,202 shares and 5,000,000 preferred shares.

Due to our inability to earn any meaningful revenue
from oil and gas exploration, our management determined in April 2011 that we should change our business plan to include toll milling
and refining.

On May 5, 2011, we effected a change of name to American Mining Corp.
by completing a short form merger with a wholly-owned subsidiary.

On April 25, 2014, Cannabics Inc., a Delaware
Corporation, purchased 20,500,000 shares of restricted stock of the Company, thus acquiring control of the Company.

On June 3, 2014, the Company's Board of Directors
declared a two-to-one forward stock split of all outstanding shares of common stock. The stock split was approved by FINRA on June 19th,
2014. The effect of the stock split increased the number of shares of common stock outstanding from 40,880,203 to 81,760,406. All common
share and per common share data in these financial statements and related notes hereto have been retroactively adjusted to account for
the effect of the stock split for all periods presented prior to June 3rd, 2014. The total number of authorized common shares and the
par value thereof was not changed by the split.

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On June 19, 2014, FINRA granted final approval
of Change of Name & Ticker Symbol of the Corporation from American Mining Corporation to Cannabics PHARMACEUTICALS INC., with the
new Ticker Symbol of “CNBX”. Said approval was predicated upon CNBX Pharmaceuticals Inc.’s filing of Articles of Merger
with American Mining Corporation with the Nevada Secretary of State on May 21st, 2014. Under the laws of the State of Nevada, CNBX Pharmaceuticals
Inc. was merged with and into the Registrant, with the Registrant being the surviving entity. The Merger was completed under Section 92A.180
of the Nevada Revised Statutes, Chapter 92A, as amended, and as such, does not require the approval of the stockholders of either the
Registrant or CNBX Pharmaceuticals Inc.

On July 24, 2014, the Company executed a Collaboration
Agreement with Cannabics Inc. (“Cannabics”), a Delaware corporation and largest shareholder of the Company. Per the terms
of the Agreement, the Company issued 18,239,594 shares of its common stock to acquire the entire institutional knowledge of Cannabics,
Inc., which primarily consists of in-process Research & Development technology, the cumulative result of its years of scientific institutional
knowledge in the fields of Molecular Biology, Cancer and Pharmacology research. Additionally, Cannabics tendered $150,000 to the Company
specifically earmarked as working funds towards prospective projects of the Company. Per the Agreement, from that day forth they have
carried forward their research and development as part of, and for the exclusive benefit of the Company, which initial findings have now
branched out into new and divergent discoveries.

On August 25, 2014, Cannabics Pharmaceuticals
Inc. incorporated a wholly owned subsidiary in Israel, named “G.R.I.N Ultra Ltd”, dedicated to advanced research and development.

On July 3, 2018, the Company announced the conclusion
of its Clinical Trial of Cannabics SR 5mg drug for Cancer Anorexia Cachexia Syndrome, as noted on the press release of that date.

On June 16th, 2020, the Company announced
its appointment of Dr. Erez Scapa, MD, to its Scientific Board of Advisors. Dr. Scapa is an Expert in Invasive Gastroenterology in the
Sourasky Medical Center in Tel-Aviv, Israel, where he is head of the Endoscopic Submucosal Dissection (ESD) program.

On August 5th, 2020, the Company announced
its appointment of Dr. Dana Ben-Ami Shor to its Scientific Board of Advisors, where she will help lead the design and implementation of
the company's clinical validation plan of its novel drug candidates for the treatment of colorectal cancer.

On August 20th, 2020, the Company announced
the creation of a new Division for its Anti-Tumor drug candidate RCC-33, for the treatment of colorectal cancer. The emanates from the
Company’s focus on a clinical validation path, including in-vivo experiments, collaborations with key medical centers, and
the preparation of a product dossier with which the company plans to schedule a Pre IND-Meeting with the U.S. Food and Drug Administration
(the “FDA”).

On October 18th, 2021, the Company
filed 2 new Provisional Patent applications on Compositions and Methods for treating cancer, including colorectal cancer and early intervention
therapy for colorectal cancer patients.

On May 10, 2022, the Company changed its name
from “Cannabics Pharmaceuticals Inc.” to the current CNBX Pharmaceuticals Inc.; effectuated a one-for-one hundred twenty (1:120)
reverse split of the issued and outstanding shares of common stock of the Company and decreased its authorized shares of preferred stock
from 100,000,000 to 5,000,000 as noted in the 8K of May 13th, 2022.

On July 20th, 2022, Dr. Eyal Ballan
resigned his position as Chief Technical Officer, and was replaced by Dr. Sanja Goldberg as noted in the 8K of July 24th, 2022.
Sanja is no longer with the company but could be called back.

On May 12, 2022, the Company effected a reverse-split of its common stock on a 1:120 basis.

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Our Business:

Company Overview

We are a clinical-stage company specializing in
the discovery, development and commercialization of novel cannabinoid-based products and innovative technologies for the treatment of
cancer.

Our first lead product candidate is Cannabics
SR the oral capsule developed for the treatment of patients with advanced cancer and cancer anorexia cachexia syndrome (CACS), showed
promising results in a peer-reviewed clinical study that concluded the results justify a larger clinical study. For oncology, we intend
to pursue a broad strategy of combining our technology platforms with conventional oncology therapies, based on their mechanisms of action,
safety profiles and versatility. Our leading anti-neoplastic drug candidate under development for Colorectal Cancer (CRC) is RCC-33, a
first-in-class therapy being developed primarily in two settings: one to reduce tumor cell activity in CRC patients as a standalone in
neoadjuvant treatment or “window of opportunity” at the time after colonoscopy, prior to cancer staging; and another for patients
with refractory to therapy and adjuvant to surgery also at the time after colonoscopy. Neoadjuvant treatment is the administration of
antitumor therapy as a first step to shrink a cancerous tumor prior to surgical intervention. Upon fundraising we intend to initiate a
Phase I/II clinical trials for both candidates in 2026.

1. General:

CNBX Pharmaceuticals Inc. is a clinical stage
pharmaceutical company primarily focused on the development of novel cannabinoid-based products and innovative technologies for the treatment
of cancer.

Upon financing the company will prepare to launch
Phase I/II (a) clinical study in 2026, for the evaluation of its lead drug candidates Cannabics SR for the treatment of patients with
advanced cancer and cancer anorexia cachexia syndrome (CACS) and RCC-33 for the treatment of colorectal cancer.

Our company’s core activities consist of:

·
Drug Discovery: development of novel molecular formulations and drug candidates;

·
Intellectual Property: filing of corresponding IP to protect our products; and

·
Regulatory Affairs: initiation of the regulatory pathway for each drug candidate in our development pipeline

Our current business model is to undertake an
FDA regulatory pathway for each of the new drug candidates under IND (Investigational New Drug) classification and complete a successful
Phase I/II(a) clinical study (toxicity and proof of concept in humans). In reaching this milestone, where an initial feasibility in humans
was demonstrated, the company will have gained several commercial opportunities for capitalizing on each such product candidate, including
entering into commercial agreements with larger pharma corporations. Accordingly, our company does not engage in any manufacturing, distribution,
or sales of products, nor is it foreseeable to expect that we will in the near future.

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2. Development pipeline:

2.1. Cannabics SR
for Cancer Anorexia-Cachexia Syndrome

Overview

We are developing Cannabics SR as a product
candidate for the treatment of CACS. Cannabics SR is a sustained-release oral capsule containing a standardized compound of cannabinoids
that has demonstrated a clinically significant weight increase in CACS patients in a peer-reviewed pilot study conducted by Dr. Gil Bar-Sela
of the Rambam Hospital Health Care Campus, Division of Oncology, in Haifa, Israel. Our patent-pending technology provides for a convenient,
once or twice daily administration, with rapid onset and a steady state of therapeutic effect for a 6 to 8-hour duration.

Cancer Anorexia-Cachexia Syndrome

CACS is a common complication of cancer associated
with high morbidity and mortality. It is a complex metabolic syndrome in which a persistently elevated basal metabolic rate is not compensated
for by adequate calorie or protein intake, causing involuntary and progressive weight loss leading to increasing functional impairment
in cancer patients, especially in advanced stages of the disease. Once established, CACS cannot presently be reversed using available
pharmacological or nutritional support techniques.

Unlike starvation, body-weight loss in CACS patients
arises mainly from loss of muscle mass, characterized by increased catabolism of skeletal muscle and decreased protein synthesis. This
weight loss is associated with important clinical outcomes such as increased morbidity, diminished effectiveness of chemotherapy, muscle
wasting, inflammation, fatigue, and reduced survival expectations. The impact of CACS on the patient is not, however, limited to the effect
of weight loss. Quality of life, functional abilities, symptoms, psychological outcomes, and social aspects are all affected by CACS.

According to the National Cancer Institute, nearly
one-third of cancer deaths can be attributed to the severe weight loss and “metabolic mutiny” associated with CACS, and more
than 50% of patients with cancer die with cachexia being present. The overall prevalence of CACS is currently estimated to range from
40% at cancer diagnosis to 70-80% in advanced phases of the disease (Source: Critical Reviews in Oncology/Hematology, 2013;88(3):625-636),
while the overall prevalence of weight loss in cancer patients may be as high as 86% in the last 1-2 weeks of life (Source: Journal
of Pain and Symptom Management 2007;34:94–104).

The cause and subsequent development of CACS is
still poorly understood, but several factors and biological pathways are known to be involved, including inflammation, decreased secretion
of anabolic hormones, and altered metabolic response. While there have been important advances in the study of CACS over the past decade,
including progress in understanding its mechanisms and the development of promising pharmacologic and supportive care interventions, there
is presently no effective pharmacologic therapy for CACS.

Current treatments for CACS are generally based
on nutritional support and CACS pathophysiology-modulating drugs, with the most common being the progestogens, megestrol and medroxyprogesterone,
and corticosteroids. Progestogens appear to stimulate appetite and improvements in body weight by increasing adipose tissue, but have
not been confirmed to augment lean body mass. Megestrol also carries an increased risk of mortality and thromboembolism. Nonetheless,
megestrol is the only FDA approved treatment option for CACS and no drug to date has been shown to be superior to it in efficacy and tolerability.
Corticosteroids are also considered effective in stimulating appetite and reducing fatigue but should only be used for short periods and
in selected cases because of side effects from longer term use, such as insulin resistance, fluid retention, steroidal myopathy, skin
fragility, adrenal insufficiency, and sleep and cognitive disorders. Other drugs are being investigated or are in development. Given the
dearth of approved therapies, we believe that CACS remains a significant area of unmet medical need.

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Cannabinoid Therapies for CACS

Cannabis has long been suggested as a well-tolerated,
safe, and effective option to help patients cope with cancer related symptoms with fewer serious side effects than most prescription drugs
currently used as anti-emetics, analgesics, and the like. As such, cannabinoids are finding application in palliative care for reducing
nausea and vomiting, alleviating cancer pain, and stimulating appetite, as well as improving quality of life in cancer patients. Dronabinol
(Marinol®) and nabilone (Cesamet®), two drugs based on synthetic cannabinoids, have each been approved by the FDA for the treatment
of chemotherapy-related nausea in patients who do not respond to conventional antiemetic therapy. Another drug, nabiximols (Sativex®),
a specific cannabis extract, is approved in Canada and the United Kingdom for symptomatic relief of pain in advanced cancer patients.

Despite interest in cannabinoid-based therapies
as a treatment for CACS, their use has been limited by impediments beyond the legal status of cannabis. The most significant obstacle
is the lack of clinical research demonstrating their efficacy. While there is evidence that cannabinoids improve appetite, body weight,
body fat level, caloric intake, mood, and quality of life in cancer patients, the few studies on these effects have yielded mixed and
inconclusive findings. In addition, some of these studies have suffered from methodological constraints that limit any ability to draw
firm conclusions.

The therapeutic use of cannabinoids has also been
inhibited by limitations associated with traditional administration routes that reduce their effectiveness. Smoking and ingestion of cannabis
suffer from wide variability in potency due to a lack of standardized and reproducible formulations. The ingestion of unformulated cannabis
has also been associated with poor absorption and low bioavailability versus other administration routes, requiring higher doses and a
greater risk of negative side effects. Additionally, the lack of available information on cannabinoid strains has made it difficult for
healthcare providers to establish dosing rates. In our experience, however, the principal concern of patients with respect to medical
cannabis lies in the undesirable side effects, such as disorientation and dizziness, which result from significant variability in peak
blood levels of active cannabinoids soon after administration. We further believe that these side effects, which are common among immediate
release methods, are a significant factor in the failure of patients to adhere to recommended treatment regimens and are therefore a pervasive
threat to their health and wellbeing.

Cannabics SR

Cannabics SR is an oral composition in the
form of a hydroxypropylmethylcellulose (HPMC) capsule containing a patent-pending formulation of cannabinoid extracts suspended in a lipid
emulsion. It provides a relatively rapid onset of action, typically within 30-40 minutes, followed by a gradual and sustained release
of active cannabinoids, resulting in a steady state level of beneficial effects for up to 6 to 8 hours with each capsule. Cannabics SR
provides a consistent, predictable concentration of cannabinoids with an absorption profile and bioavailability of active ingredients
that we believe to be superior to other oral cannabinoid administrations. We believe that the multifactorial benefits of the active pharmaceutical
ingredients in Cannabics SR address an unmet medical need for a safe and effective treatment of CACS, leading to improved patient
adherence and better health outcomes.

Cannabics SR capsules contain only food grade
materials without any artificial additives. The active ingredients of each capsule are standardized in composition, formulation, and dose,
and are comprised of only pure, natural extracts of active cannabinoids from selected strains of medical cannabis. All excipients are
recognized by the FDA as Generally Regarded as Safe.

In addition to the therapeutic potential of Cannabics SR
as a treatment for CACS, we believe that our SR technology may be formulated to serve the unique needs of patients suffering from other
indications for which a sustained release of a cannabinoid formulation may be beneficial.

Clinical Development

In 2016, we commenced a two-year pilot study to
evaluate the influence of Cannabics SR capsules on CACS, and, in particular, on weight loss in advanced cancer patients. The study
was led by Professor Gil Bar-Sela, the former Deputy Director of the Division of Oncology at Rambam Health Care Campus, Head of the Palliative
and Supportive Oncology Unit, and Head of Service for Melanoma and Sarcoma Patients.

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Patients were administered 2 × 10 mg of
Cannabics SR per 24 hours for six months. During the study, after some patients reported several psychoactive side effects, the dosage
of each capsule was reduced to 5 mg. Almost no side effects were reported with the 5 mg dosage. Participants were weighed at each physician
visit. The primary objective of the study was a weight gain of ≥10% from baseline. Of 24 patients who agreed to participate in the
study, 17 started the Cannabics SR treatment, but only 11 received the capsules for more than two weeks. Three of six patients who
completed the study period met the primary end-point. The remaining three patients had stable weights. In quality-of-life questionnaires
patients reported less appetite loss after the Cannabics SR treatment (p=0.05). According to patients’ self-reports, improvement
in appetite and mood as well as a reduction in pain and fatigue was demonstrated.

Despite various limitations, the preliminary study
demonstrated a weight increase of ≥10% in 3 out of 17 (17.6%) of patients with doses of 5 mg × 1 or 5 mg × 2 capsules daily,
without significant side effects. The remaining patients had stable weights. Also, all patients who remained in the study for at least
4.5 months reported an increase in appetite, as did 83% of the patients who completed the study. For 50% of the patients who completed
the study, there were reports of pain reduction and sleep improvement. Additional results showed a significant decrease of appetite loss
complaints among 83% of the patients who completed the study. (See Bar-Sela, Gil et al. “The Effects of Dosage-Controlled
Cannabis Capsules on Cancer-Related Cachexia and Anorexia Syndrome in Advanced Cancer Patients: Pilot Study.” Integrative Cancer
Therapies vol. 18 (2019): 1534735419881498. doi:10.1177/1534735419881498.)

Figure 1: Appetite loss among
the six patients who completed Cannabics SR treatment, as reported on European Organization of Research and Treatment of Cancer Quality
of Life Questionnaire (EORTC QLC-C30)

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Commercialization

The results of our planned pilot studies may permit
us to commercialize Cannabics SR in Israel under license by the Israeli Ministry of Health.

On May 13, 2020, the Israeli Ministry of Economy
signed a Free Export Order, authorizing the export of GMP certified medical cannabis products from Israel. We are currently evaluating
our export opportunities and optimal commercialization path for Cannabics SR across all available international markets, particularly
with regard to the European Union, Canada, and Australia.

Cancer and Cancer Anorexia Cachexia Syndrome (CACS)
Market Analysis

The dynamics of the cancer cachexia market are
expected to shift in the coming years as a result of the positive outcomes of some of the rare candidates during the development stage
by key players that are in the early stages of clinical development have the potential to create a significant positive shift. The emerging
therapies are projected to be launched during the forecast period. In addition, the dearth of effective therapies for this condition presents
a great opportunity for pharma companies to create novel drugs because there is less competition in the cancer cachexia market. Moreover,
the rising awareness about the condition is also impacting the growth of the cancer cachexia market positively.

The Global Cancer Cachexia Market Size is projected
to reach USD 2.93 billion by 2027, exhibiting a CAGR of 4.8% during the forecast period [2020-2027].

https://www.fortunebusinessinsights.com/cancer-cachexia-market-103262

North America region holds the largest market
share of the global Cancer Anorexia-Cachexia Syndrome Drug North America is expected to hold a large market share in the global Cancer
Anorexia-Cachexia Syndrome Drug Market due to the growing incidence of cancer cases. The International Agency for Research on Cancer (IARC)
claims 13 million new cancer cases worldwide. The World Cancer Report provides that the incidence rate of new cancer cases is increased
by 50% to 15 million in 2020. The existence of a highly developed healthcare system, the high degree of acceptance by medical practitioners
of novel products, the total availability of advanced technological tools, FDA approval of new drugs and many companies are developing
oncology products (https://www.datamintelligence.com/research-report/ cancer-anorexia-cachexia-syndrome-drug-market)

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2.2 RCC-33: colorectal cancer treatment
drug candidate

Our anti-neoplastic flagship product under development,
RCC-33, is an antitumor drug candidate for the treatment of colorectal cancer, which is the 3rd most diagnosed and 2nd
most lethal of all cancers, with approximately 2M new cases being diagnosed annually worldwide and a current market estimated at $12B,
and which is expected to reach $17B by 2027.

The RCC-33 proprietary formula consists of a specific
synthetic cannabinoid molecular composition that has demonstrated the potential to reduce colorectal cancer tumor volume by over 30% in
repeated in-vivo studies performed.

Overview

Cancer and Cannabinoids

Cancer is a general term used to describe a group
of more than 100 related diseases characterized by uncontrolled growth and spread of abnormal cells, leading to the development of a mass
commonly known as a tumor, followed by invasion of the surrounding tissues and subsequent spread, or metastasis, to other parts of the
body. Despite enormous investment in research and the introduction of new treatments, cancer remains a critical area of unmet medical
need. According to the World Health Organization, cancer is the second leading cause of mortality worldwide, responsible for an estimated
nearly 10 million deaths in 2022. As of January 1, 2022, there were more than 18 million people with a history of cancer living in the
United States, with 2 million new cases and 611,720 cancer deaths expected in 2024 (Source: American Cancer Society. Cancer Facts &
Figures 2024).

Over the past decade, there has been growing interest
in the therapeutic value of cannabinoid compounds in oncology. Cannabis has long been suggested as a well-tolerated, safe, and effective
option to help patients cope with cancer related symptoms by reducing nausea and vomiting, alleviating cancer pain, stimulating appetite,
and improving quality of life. Beyond their palliative benefits, however, cannabinoids have also been receiving increased attention for
their anti-cancer potential, which we believe may one day revolutionize cancer therapy.

Cannabinoids are a diverse class of chemical compounds
that occur naturally within cannabis plants and are pharmacologically similar to cannabinoids produced by the human body, known as endocannabinoids.
Endocannabinoids form part of the human endocannabinoid system (ECS), a complex biological network that also includes cannabinoid receptors
and enzymes involved in cannabinoid formation, transport, and degradation. The ECS is regarded as an important endogenous system implicated
in regulation of the most vital biological processes to maintain homeostasis, assisting the body to remain stable and balanced despite
external, or environmental, fluctuations (Source: Current Pharmaceutical Design, 2016;22(12):1756-1766).

Dysregulation of the ECS owing to variation in
the expression and function of cannabinoid receptors or enzymes or the concentration of endocannabinoids has been associated with several
diseases, including cancer (Source: International Journal of Molecular Sciences, 2020;21(3):747). Indeed, the mechanisms involved
in the regulation of the ECS as well as the processes that it regulates include practically every pathway important in cancer biology.
Expression of the ECS is altered in numerous types of tumors, compared to healthy tissue, and this aberrant expression has been related
to cancer prognosis and disease outcome, depending on the origin of the cancer (Source: British Journal of Pharmacology, 2018;175(13):2566-2580).
Recent studies suggest that endocannabinoids contribute to maintaining balance in cell proliferation and that targeting the ECS can affect
cancer growth (Source: Canadian Urological Association Journal, 2017;11(3-4):E138-E142).

Cannabinoids can interact with the cannabinoid
receptors in the ECS, sometimes with a higher affinity than endocannabinoids. As a consequence, all the processes regulated by endocannabinoids
are susceptible to interference by cannabinoids. The ability to use cannabinoids to modulate the ECS encompasses several attractive pharmacotherapeutic
targets for systemic anti-cancer treatment and has sparked considerable research examining cannabinoid action on cancer cells (Source:
Pharmacological Reviews, 2006;58(3):389-462).

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Cannabinoids have demonstrated selective anti-tumor
properties in preclinical studies, exerting anti-proliferative, proapoptotic, anti-angiogenic, and anti-metastatic and anti-inflammatory
effects depending on tumor type and specific setting (Source: Cancer Medicine, 2018:7(3):765-775). These effects appear to be more
pronounced when cannabinoids are used together versus being administered separately, a mechanism known as the entourage effect.
We believe, therefore, that cannabinoid combinations may hold promise for an improved anti-proliferative strategy for cancer management.

In addition to their potential role as anti-cancer
agents, cannabinoids have been observed to act synergistically with some conventional antineoplastic drugs, such as chemotherapeutic agents,
enhancing their effectiveness (Source: Cancer Medicine, 2018;7(3)765-775). This raises the potential for combinational therapies
that may increase the range of chemotherapeutic options available to patients and enable targeting of tumor progression at different levels
while also permitting dosages of cytotoxic drugs to be dramatically reduced without compromising efficacy.

Figure 2: Synergistic effects
of cannabis extracts and chemotherapies on cancer biopsy after treatment with the same extract and three different chemotherapy combinations

As of the date of this filing, we are not aware
of any cannabinoid-based therapies approved for the anti-cancer treatment.

Our lead product candidate is RCC-33, which we
are developing as a treatment for CRC. RCC-33 is an oral capsule containing a proprietary formulation of cannabinoids that have demonstrated
synergistic efficacy in reducing the viability of human colon cancer cell lines in preclinical studies.

Colorectal Cancer

CRC is one of the more common forms of cancer
worldwide, representing a significant challenge to the global healthcare system. According to the World Health Organization, CRC is the
third most diagnosed cancer in the world and the second-leading cause of cancer-related mortality. In the United States, there were approximately
1,392,445people living with CRC in 2021(Source: National Cancer Institute. “Cancer Stat Facts: Colorectal Cancer”).
In 2025, an estimated 152,810 cases of colon cancer and 44,850 cases of rectal cancer will be diagnosed in the US, and a total of 53,010
people will die from these cancers. In 2024 of all cancers in people over 50, Colorectal cancer was #1 in Men and #2 for Women. (Source:
American Cancer Society. “Cancer Facts & Figures 2024”).

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Most CRCs begin as a noncancerous growth called
a polyp that develops on the inner lining of the colon or rectum. The most common kind of polyp is called an adenomatous polyp or adenoma.
According to the American Cancer Society, an estimated one-third to one-half of all individuals will eventually develop one or more adenomas.
Although all adenomas have the capacity to become cancerous, fewer than 10% are estimated to progress to invasive cancer. The likelihood
that an adenoma will evolve into cancer increases as it becomes larger or when it acquires certain histopathological characteristics.
Adenomas that become cancerous, called adenocarcinomas, comprise nearly 96% of all CRCs (Source: American Cancer Society. “Colorectal
Cancer Facts & Figures 2020-2022”). Adenocarcinomas may grow into blood vessels or lymph vessels, increasing the chance
of metastasis to other anatomical sites.

CRC usually develops slowly, over a period of
10 to 20 years. The complex sequence of events occurring during initiation, development and propagation of adenocarcinomas is likely the
result of a lifelong accumulation of mutations caused by both genetic and environmental factors known as the adenoma to carcinoma sequence.
While the specific cause of any particular case of CRC is often unknown, more than one-half of all cases and deaths are attributable to
lifestyle and environmental factors, such as smoking, unhealthy diet, high alcohol consumption, physical inactivity, and excess body weight
(Source: American Cancer Society. “Cancer Facts & Figures 2020”).

CRC does not usually cause symptoms until the
disease is advanced, therefore early detection of adenomas by screening is vital. If not treated or removed, an adenoma can become a potentially
life-threatening cancer.

Current Standard of Care

Treatment options for CRC patients depend on several
factors, including the type and stage of cancer, possible side effects, and the patient’s preferences and overall health. Surgical
removal of the tumor is the most common form of treatment, particularly in the early stages of malignancy. Patients with more advanced
stages of CRC may be given adjuvant chemotherapy to kill any cancer cells remaining after surgery, though standard chemotherapy is associated
with severe side effects and provides marginal benefit to the majority of patients. While radiation therapy is often used to treat rectal
cancer, it is not generally recommended for colon cancer patients except in the later stages of the disease (Source: American Cancer
Society. “Treating Colorectal Cancer”).

CRC is a heterogeneous disease with distinct clinical,
molecular, and pathophysiological characteristics. As a result, the response to treatment is variable between patients, even when they
are diagnosed at the same clinical stage. Such heterogeneity remains an obstacle to the optimization of treatment for each individual.
Researchers are continuing to investigate new treatment options, such as immunotherapy and targeted therapy, that focus upon the genes,
proteins, and other factors in a particular tumor (Source: American Cancer Society. “Advances in Colorectal Research”).

Immunotherapy uses the body’s own immune
system to kill cancer cells. There are already several FDA-approved immunotherapy options for CRC, such as pembrolizumab (Keytruda®),
nivolumab (Opdivo®), and ipilimumab (Yervoy®). Many immunotherapies that have shown promise in addressing other types of cancer
are also being tested for CRC. While immunotherapy has had some encouraging results, significant limitations remain. Its efficacy is often
unpredictable, and the treatment can lead to the body becoming resistant or result in off-target toxicities where the body’s immune
system attacks healthy tissue. Immunotherapy may take longer than other protocols and it is substantially more expensive than classical
treatments (Source: Pharmacy & Therapeutics, 2017;42(8):514-521).

Targeted therapy uses drugs to target specific
molecules inside cancer cells or on their surface to slow the growth of cancer, destroy cancer cells, and relieve cancer symptoms. There
are different types of targeted therapy drugs, each working differently depending on what molecule the drug is targeting. A treatment
is chosen based on the types of molecules expressed on the patient’s tumor cells, which allows doctors to tailor cancer treatment
for each person. Several targeted therapy drugs, such as bevacizumab (Avasin®) and cetuximab (Erbitux®), are already used to treat
advanced CRC. Despite showing clinical promise, targeted therapy has challenges, such as tumor heterogeneity, off-target toxicity, and
acquired resistance (Source: Medical Research Journal, 2019;4(2):99-105). The lack of biomarkers by which to identify patients
having a high probability of response is also a particularly significant obstacle. As with immunotherapy, the cost of targeted therapy
is substantially higher than classical treatments.

We believe that there is no “magic bullet”
to cure cancer and that a personalized combination of cancer treatments may be the best course for long term survival benefits in each
case. To that end, the development of more prevention strategies and novel agents will be essential.

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Cannabinoids and Colorectal Cancer

One area of increasing interest in the treatment
of CRC lies in the development and use of cannabinoid therapeutics. The ECS is regarded as an important regulatory system in the gastrointestinal
tract, being involved in several important functions such as motility, secretion, sensation, inflammation, and carcinogenesis. Recent
studies advocate that the ECS plays a critical role in the development of CRC and should therefore be considered as an appropriate target
for CRC inhibition (Source: Frontiers in Pharmacology, 2016;7:361). The expression of ECS components in CRC has been found to be
increased and associated with poorer prognosis and advanced stages of disease (Source: Cannabis and Cannabinoid Research, 2018, 3(1):272-281).
For example, cannabinoid receptors have been found to be overexpressed in tumor cells of the colon and this up-regulation has been postulated
to be an indicator of cancer outcome (Source: British Journal of Pharmacology, 2018; 175(13): 2566-2580).

Research on the effects of cannabinoid compounds
on CRC has demonstrated an ability to reduce the viability of CRC cell lines in vitro (Source: Cancer Medicine, 2018;7(3):765-775),
while there is also convincing scientific evidence that cannabinoids are able to prevent or reduce carcinogenesis in different animal
models of colon cancer (Source: Expert Review of Gastroenterology & Hepatology, 11:10, 871-873).

We believe that cannabinoids are a promising therapeutic
agent for the treatment of CRC. We have conducted several in vitro unpublished studies using our bioinformatics platform to
confirm that cannabinoids cause necrosis in colon cancer cells. While many cannabinoids demonstrate levels of toxicity on cancer cells,
we have found that certain cannabinoid extracts and combinations show increased levels of toxicity relative to other isolated or combined
cannabinoids. These findings have spurred the development of RCC-33, our product candidate for the treatment of CRC.

Figure 3: Synergistic effects
of different cannabinoid combinations on viability of a colon cancer cell line.

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RCC-33

We are developing RCC-33 as an oral capsule or
solution containing high concentrations of the cannabinoids CBDV and CBGA in a novel formulation, which we believe may be effective in
the treatment of adenocarcinomas of the colon. The cannabinoids in RCC-33 have demonstrated complex synergistic anti-tumor effects in
combination, with no psychoactive effect. In our preclinical in vitro studies evaluating the influence of 15 different cannabinoids
on human colon cancer cell lines (RKO, HCT116), alone and in combination, RCC-33 demonstrated clear efficacy in reducing the viability
of colon cancer cells versus alternative cannabinoid combinations. Importantly, we could detect significant reduction effect on tumour
development in mice inoculated with human colorectal cancer cells.

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Development Plan

The company, upon financing will prepare to launch
Phase I/II (a) clinical study in 2026, for the evaluation of its lead drug candidates Cannabics SR for the treatment of patients with
advanced cancer and cancer anorexia cachexia syndrome (CACS) and RCC-33 for the treatment of colorectal cancer. We plan to conduct further
preclinical studies to establish the safety and efficacy before proceeding with first-in-human clinical testing.

Preclinical Studies

We plan to conduct non-clinical safety
studies following Good Laboratory Practice (GLP) to evaluate the systemic and local toxicity of escalating doses of RCC-33 and
establish dosing parameters. The results of these preclinical studies, which are expected in the third quarter of 2026, will
guide our planned Phase I/II(a) clinical trial. The non-clinical requirements to support the development program will be verified
with the FDA at a pre-IND meeting. Such studies may include repeated dose toxicity studies, male and female fertility studies,
embryofetal development studies, animal abuse related studies, pharmacokinetics studies, drug-drug interaction studies, and
others.

Clinical Trials

We plan to evaluate the safety, tolerability,
and pharmacokinetic properties of Cannabis SR and RCC-33 in a Phase I/II(a) ascending dose clinical trial in CRC patients, commencing
in 2026. The clinical trial will examine the tolerability, pharmacokinetics, pharmacodynamics, and efficacy of multiple doses of RCC-33
in CRC patients. We are currently identifying potential contract research organizations and clinical trial centers to conduct the Phase
I/II(a) human proof of concept study, which is estimated to cost $6,500,000. As of the date of this filing, however, the Company does
not have sufficient funds to complete the Phase I/II(a) study.

Subject to the results from our Phase I trials,
we plan to submit an IND to the FDA for RCC-33 with the clinical protocol for a Phase II double-blind placebo controlled clinical trial
evaluating RCC-33 in patients with CRC at various dosing levels versus placebo. The outcomes from the planned Phase II human proof of
concept trial will inform our decision regarding further steps in the clinical development of RCC-33.

Our Pipeline:

In addition to RCC-33, our colorectal cancer
treatment drug candidate, the company has several other drug candidates under development, including PLP-33 for the local treatment
of Lateral Spreading, or Sessile, colorectal polyps during colonoscopy, BRST-33 for the treatment of breast cancer, MLN-33
for the treatment of Melanoma and PRST-33 for the treatment of prostate cancer. These additional drug candidates are in the early
stage of development and the company expects to complete the in-vivo research for each product by end of 2027.

2.3 Product
lines currently not actively developed:

The company has several product lines that are
currently not being actively developed following company’s decision to focus its resources and attention exclusively on the development
of its FDA route drug candidates, and SR Capsule described above. The product lines not actively developed include:

Cannabics CDx (evaluate) Drug Sensitivity
Test

Cannabics CDx is an ex-vivo drug sensitivity test
under development to provide healthcare providers with clinical decision support data from which they can identify, for a particular cancer
patient undergoing cannabinoid therapy, which cannabinoids or cannabinoid combinations may have the most beneficial anti-cancer effects,
and which cannabinoids may be contraindicated.

Company may revisit this decision at a later stage
after launching the first in human clinical studies for the validation of its colorectal cancer treatment drug candidate RCC-33.

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3. Market opportunity for cancer treatment drug candidates:

3.1. Neoadjuvant
therapy:

According to the National Cancer Institute, Neoadjuvant
Therapy is a "treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery”.

Limitations:

·
Mild to severe side effects

·
Suppressed immune system

·
Potential resistance of tumor residues to postoperative chemotherapy *

* “nCRT increases ITGH and may result in the expansion of resistant
tumor cell populations in residual tumors”.

Frontiers in Oncology. 2019

The Effects of Neoadjuvant Chemoradiation in
Locally Advanced Rectal Cancer—The Impact in Intratumoral Heterogeneity.

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3.1.1 Neoadjuvant
therapy in rectal cancer

Neoadjuvant chemoradiotherapy has become the standard
treatment for locally advanced rectal cancer. Neoadjuvant chemoradiotherapy not only can reduce tumor size and recurrence, but also increase
the tumor resection rate and anus retention rate with very slight side effect. Comparing with preoperative chemotherapy, preoperative
chemoradiotherapy can further reduce the local recurrence rate and downstage. Middle and low rectal cancers can benefit more from neoadjuvant
chemoradiotherapy than high rectal cancer.

3.1.2 Neoadjuvant
therapy in breast cancer

In early breast cancer, surgery is the mainstay
of curative treatment. Complementary local radiotherapy and systemic - adjuvant endocrine therapy or chemotherapy treatments are associated
with the aim of reducing the risk of relapse according to the clinicopathological characteristics of the tumor. However, the possibility
of administering these therapies prior to surgery in neoadjuvant setting offers several advantages:

·
reduction in tumor size to improve respectability,

·
increased rate of conservative surgery improving esthetic results,

·
reduction in the extent of axillary surgery,

·
early treatment of micrometastatic disease

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Fig5. Asco Guidelines for neoadjuvant therapy in breast cancer

According to ASCO guidelines most of the patients
are eligible for neoadjuvant chemotherapy and are the end consumers of BRST-33, while the current treatment regimen negates severe side
effects.

Side effects and risks of standard of care:

·
nausea or vomiting

·
hair loss

·
nail or skin changes

·
appetite loss

·
weight changes

·
diarrhea or constipation

·
mouth sores

·
Fatigue

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3.2. Cannabinoid
Neoadjuvant Therapy

For some time now, the FDA has promoted clinical
studies on Cannabinoids as a growing range of stakeholders has expressed interest in development of drugs that contain cannabis and compounds
found in cannabis. Recent legislative changes have also opened new opportunities for medical cannabis clinical research. As this body
of research progresses and grows, the FDA is working to support drug development in this emerging scientific arena.

RCC-33 & BRST-33 – Potential safe
drugs improving rectal and breast cancer neoadjuvant standard of care

RCC-33 & BRST-33 anticipated
advantage over standard of care:

·
Non-Suppressed immune system

·
potential low toxicity which is even more important in neoadjuvant treatment since patients will suffer less side effects. Since the two drug candidates are based on two natural molecules (cannabinoids) found in the Cannabis plant, the safety of the molecules in the short and long run is potentially lower. Not like in a new drug entity in which toxicity could not be predicted.

·
Overcoming Potential resistance of tumor residues to postoperative chemotherapy

4. Outsourced GMP manufacturing and commercial operation:

4.1. Outsourced
GMP manufacturing

Our current position is that all of our Chemistry
Manufacturing and Controls (CMC) required for the approval process of our drug candidates is to be outsourced. The RCC-33 formulation,
as well as all additional drug candidates in our pipeline, while inspired by natural molecules, could consist only of formulations made
from chemically synthesized molecules, or APIs (Active Pharmaceutical Ingredients). Our
Company is not engaged in the development of any botanical or botanically based product/s. Additionally, in view of our upcoming submission
of a pre-IND meeting request with the FDA, the Company may enter a new agreement with Purisys, a supplier of GMP (Good Manufacturing Practice)
grade APIs suited for Clinical Stage Products. Purisys is a large and long-established US corporation with a long track record of working
with the FDA. Accordingly, under said agreement, we will request that Purisys will also support CNBX throughout an IND filing process,
including providing all necessary and related information concerning CMC in the form of a comprehensive technical package to be presented
to the FDA. APIs supplied under said agreement will be used by Company in Phase I/II (a) clinical studies that it is planning to launch
in 2026.

4.2. Commercial
Operations

We have not established a sales, marketing, or
product distribution infrastructure. We plan to commercialize any drugs we develop through licensing arrangements and strategic partnerships
with established companies in the pharmaceutical industry having strong marketing capabilities and distribution networks. We generally
intend to advance our drug candidates through Phase I and Phase II clinical trials as appropriate in order to establish their clinical
and commercial potential before negotiating the terms of any licensing or collaboration. We believe that this approach will achieve the
fullest marketing and distribution potential of any drugs or other products that we may develop in the short term.

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5. Our Research and Development:

To address these problems and improve clinical
outcomes, CNBX Pharmaceuticals focuses on the development of diagnostics that monitor cancer progression and cannabinoid-cancer sensitivity
tests to tailor treatment of cancer with cannabinoid medicine. Utilizing novel High-Throughput Screening (HTS) methods to perform studies
on cancer cell lines and on circulating tumor cells (CTC) derived from cannabis medicated patients.

We aim to treat a wide scope of cancers both as
the main treatment and as a conjugate to conventional chemotherapy. We believe a significant need remains for novel drugs for patients
who do not respond to existing therapies or for whom these therapies bear undesirable side effects. We recognize the potential therapeutic
applications of the synergistic effects of these active compounds thus building the methodology and procedures that decipher specific
ratios of active compounds in regard to their antitumor activity.

Once a series of potentially active cannabinoids
is identified for a specific cancer type, we then test and confirm their activity through in vitro and ex-vivo evaluation
studies to determine their potential activity. Through this process, we are able to assess their therapeutic potential. The results of
our pre-clinical experiments provide starting points for our clinical development programs.

6. Competition:

The biotechnology and pharmaceutical industries
are characterized by rapidly advancing technologies, intense competition and a strong emphasis on proprietary products. We believe that
our scientific knowledge, experience, technology and development capabilities provide us with competitive advantages, but we face competition
from many different sources, including major pharmaceutical, specialty pharmaceutical and biotechnology companies, academic institutions,
governmental agencies and public and private research institutions. Many of our current and potential competitors have longer operating
histories and substantially greater financial, scientific, technical, intellectual property, regulatory and human resources than we have,
as well as greater experience in developing and commercializing products, including obtaining FDA and other regulatory approvals.

As the medical use of cannabis increasingly receives
government approval worldwide, we face growing competition from many new and existing companies seeking to develop cannabinoid-based therapies.
Companies currently known to be developing cannabinoid-based human therapeutics include GW Pharmaceuticals PLC, Cannabis Science Inc.,
InMed Pharmaceuticals Inc., Emerald Bioscience Inc., Corbus Pharmaceuticals Holdings Inc., Zynerba Pharmaceuticals Inc., PharmaCyte Biotech, Inc.,
Tetra Bio-Pharma Inc. and Cure Pharmaceutical Holding Corp.

Many of our competitors are conducting research
targeting the same technologies, applications, and markets as we are. Consequently, they may develop products for the same indications
we are pursuing or may pursue in the future that are more effective, better tolerated, more widely-prescribed or accepted, more useful,
and less costly. Any products that we successfully develop and commercialize will compete with existing products, as well as those currently
in development or that may become available in the future.

In addition to competing for market position,
we will also compete in terms of recruiting and retaining qualified personnel, acquiring intellectual property, establishing clinical
trial sites, and enrolling patients for clinical trials and in obtaining funding.

Given the rapid changes affecting the global,
national, and regional economies in general and cannabis-related medical research and development in particular, we may not be able to
create and maintain a competitive advantage in the marketplace. Time-to-market is a critical factor in our industry and our success will
depend on our ability to timely develop innovative technologies that will be accepted by patients. Our competitors may be better able
to react to market changes, respond more rapidly to new regulations, or allocate greater resources to the development of their products
than we can, which may result in our technologies and products becoming obsolete before we are able to enter the market, recover the expenses
incurred to develop them, or generate significant revenue. Our success will depend, in part, upon our ability to develop our product candidates
in a timely manner, keep our future products current with advancing technologies, achieve market acceptance of our future products, gain
name recognition and a positive reputation in the healthcare industry, and establish successful marketing, sales, and distribution efforts.
We cannot be certain that we will be able to compete against current or future competitors or that competitive pressure will not seriously
harm our business prospects.

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7. Competitive Factors:

The Pharmaceutical industry is highly competitive
and we will be competing with many other and better financed companies. We are a clinical stage and early stage-biotech pharmaceutical
company, with relatively deminimis cash flow. We compete with other early-stage bio-tech and pharmaceutical companies for financing from
a limited number of investors that are prepared to make investments in early-stage development companies. The presence of competing early-stage
pharmaceutical companies may impact on our ability to raise additional capital in order to fund our research and development if investors
are of the view that investments in competitors are more attractive based on their subjective analysis of our company, the general market
conditions and the price of the investment offered to investors.

8. Regulations:

CNBX Pharmaceuticals Inc. is purely a Bio-Technology
Pharmaceutical company which licenses use of its Intellectual Property, it does not produce, manufacture or provide any product in any
location. We were duly licensed by the Israeli Health Ministry for our research in Israel. Beyond the Israeli Health Ministry and the
FDA regulatory pathway for our drug candidates as described above, we are not under the aegis of any Federal or State regulatory scheme
as we have no manufacturing activity. Any licensee whom we engage must be duly licensed and certified according to all pertinent local
government regulations in their jurisdiction. The Company is exploring drug development within approved laboratory clinical trial settings
conducted within approved regulatory frameworks. Should any prescription drug product be developed by the Company, such drug product will
not be commercialized prior to receipt of applicable regulatory approval, which will only be granted if clinical evidence of safety and
efficacy for the intended use(s) is successfully developed.

United States

In the U.S., the FDA and other federal, state,
local and foreign regulatory agencies impose substantial requirements upon the clinical development, approval, labeling, manufacture,
marketing and distribution of drug products. These agencies regulate, among other things, research and development activities and the
testing, approval, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, advertising and promotion of
any prescription drug product candidates or commercial products. The regulatory approval process is generally lengthy and expensive, with
no guarantee of a positive result. Moreover, failure to comply with applicable FDA or other requirements may result in civil or criminal
penalties, recall or seizure of products, injunctive relief including partial or total suspension of production, or withdrawal of a product
from the market.

Cannabis (other than hemp) is strictly controlled
under the Controlled Substances Act (21 U.S.C. § 811) (the “CSA”) as a Schedule I substance. Schedule I substances
by definition have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision,
and a high potential for abuse. Schedule I and II drugs are subject to the strictest controls under the CSA, including manufacturing
and procurement quotas, security requirements and criteria for importation. Anyone wishing to conduct research on substances listed in
Schedule I under the CSA must register with the U.S. Drug Enforcement Administration (the “DEA”), and obtain DEA approval
of the research proposal. For any product containing cannabis to be available for commercial marketing in the United States, cannabis
must be rescheduled, or the product itself must be scheduled, by the DEA to Schedule II, III, IV or V. Scheduling determinations by the
DEA are dependent on FDA approval of a substance or a specific formulation of a substance.

The process required before a prescription drug product candidate may
be marketed in the United States generally involves:

·
completion of extensive non-clinical laboratory tests, animal studies and formulation studies, all performed in accordance with the FDA’s Good Laboratory, Good Clinical and/or Manufacturing Practice regulations;

·
submission to the FDA of an IND, which must become effective before human clinical trials may begin;

·
approval by an institutional review board or independent ethics committee at each clinical trial site before each trial may be initiated;

·
for some products, performance of adequate and well-controlled human clinical trials in accordance with the FDA’s regulations, including Good Clinical Practices, to establish the safety and efficacy of the prescription drug product candidate for each proposed indication;

·
submission to the FDA of a New Drug Application (“NDA”);

·
Satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the drug will be produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality, and purity; and

·
FDA review and approval of the NDA prior to any commercial marketing, sale or shipment of the drug.

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The testing and approval process requires substantial
time, effort and financial resources, and the Company cannot be certain that any approvals for its prescription drug product candidates
will be granted on a timely basis, if at all.

Non-clinical tests include laboratory evaluations
of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animals and other animal studies. The results
of non-clinical tests, together with manufacturing information and analytical data, are submitted as part of an IND to the FDA. Some non-clinical
testing may continue even after an IND is submitted. The IND also includes one or more protocols for the initial clinical trial or trials
and an investigator’s brochure. An IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within
the 30-day time period, raises concerns or questions relating to the proposed clinical trials as outlined in the IND and places the clinical
trial on a clinical hold. In such cases, the IND sponsor and the FDA must resolve any outstanding concerns or questions before any clinical
trials can begin. Clinical trial holds also may be imposed at any time before or during studies due to safety concerns or non-compliance
with regulatory requirements.

An independent institutional review board, at
each of the clinical centers proposing to conduct the clinical trial, must review and approve the plan for any clinical trial before it
commences at that center. An independent institutional review board considers, among other things, whether the risks to individuals participating
in the trials are minimized and are reasonable in relation to anticipated benefits. The independent institutional review board also approves
the consent form signed by the trial participants and must monitor the study until completed. The FDA, the independent institutional review
board, or the sponsor may suspend or discontinue a clinical trial at any time on various grounds, including a finding that the subjects
are being exposed to an unacceptable health risk. There also are requirements governing the reporting of ongoing clinical trials and completed
clinical trials to public registries.

Clinical trials to support NDAs for marketing
approval are typically conducted in three sequential phases, but the phases may overlap. In general in Phase 1, the initial introduction
of the drug into healthy human subjects or patients, the drug is tested to assess metabolism, pharmacokinetics, pharmacological actions,
side effects associated with increasing doses and, if possible, early evidence on effectiveness. Phase 2 usually involves trials
in a limited patient population to determine the effectiveness of the drug for a particular indication, dosage tolerance and optimum dosage,
and to identify common adverse effects and safety risks. If a compound demonstrates evidence of effectiveness and an acceptable safety
profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain the additional information about clinical efficacy and
safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to evaluate the overall
benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug. In most cases, the FDA requires
two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the drug. The FDA may, however, determine
that a drug is effective based on one clinical study plus confirmatory evidence. Only a small percentage of investigational drugs
complete all three phases and obtain marketing approval. In some cases, the FDA may require post-market studies, known as Phase 4
studies, to be conducted as a condition of approval in order to gather additional information on the drug’s effect in various populations
and any side effects associated with long-term use. Depending on the risks posed by the drugs, other post-market requirements may be imposed.

After completion of the required clinical testing,
an NDA is prepared and submitted to the FDA. The FDA approval of the NDA is required before marketing of the product may begin in the
U.S. The NDA must include the results of all pre-clinical, clinical, and other testing and a compilation of data relating to the product’s
pharmacology, chemistry, manufacture, and controls. The cost of preparing and submitting an NDA is substantial.

The FDA has 60 days from its receipt of an
NDA to determine whether the application will be accepted for filing based on the agency’s threshold determination that it is sufficiently
complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review. Under the statute
and implementing regulations, the FDA has 180 days (the initial review cycle) from the date of filing to issue either an approval
letter or a complete response letter, unless the review period is adjusted by mutual agreement between the FDA and the applicant
or as a result of the applicant submitting a major amendment. In practice, the performance goals established pursuant to the Prescription
Drug User Fee Act have effectively extended the initial review cycle beyond 180 days. The FDA’s current performance
goals call for the FDA to complete review of 90 percent of standard (non-priority) NDAs within 10 months of receipt
and within six months for priority NDAs, but two additional months are added to standard and priority NDAs for a new molecular
entity, or NME.

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The FDA may also refer applications for novel
drug products, or drug products that present difficult questions of safety or efficacy, to an advisory committee, which is typically a
panel that includes clinicians and other experts, for review, evaluation and a recommendation as to whether the application should be
approved. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving
an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the
facility or the facilities at which the drug is manufactured. The FDA will not approve the product unless compliance with current GMP
is satisfactory and the NDA contains data that provide substantial evidence that the drug is safe and effective in the indication studied.

After the FDA evaluates the NDA and the manufacturing
facilities, it issues either a n approval letter or a complete response letter. A complete response letter generally outlines the deficiencies
in the submission and may require substantial additional testing, or information, in order for the FDA to reconsider the application.
If, or when, those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an
approval letter. The FDA has committed to reviewing 90 percent of resubmissions within two to six months depending on the type of
information included.

An approval letter authorizes commercial marketing
of the drug with specific prescribing information for specific indications. As a condition of NDA approval, the FDA may require a risk
evaluation and mitigation strategy, or REMS, to help ensure that the benefits of the drug outweigh the potential risks. REMS can include
medication guides, communication plans for health care professionals, and elements to assure safe use, or ETASU. ETASU can include, but
are not limited to, special training or certification for prescribing or dispensing, dispensing only under certain circumstances, special
monitoring, and the use of patient registries. The requirement for a REMS can materially affect the potential market and profitability
of the drug. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the drug’s safety
or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained or problems are
identified following initial marketing.

The FDA offers a number of regulatory mechanisms
that provide expedited or accelerated approval procedures for selected drugs and indications which are designed to address unmet medical
needs in the treatment of serious or life-threatening diseases or conditions. These include programs such as Breakthrough Therapy designations,
Fast Track designations, Priority Review and Accelerated Approval, which the Company may need to rely upon in order to receive timely
approval or to be competitive.

The Company may plan to seek orphan drug designation
for certain indications qualified for such designation. Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs
intended to treat a “rare disease or condition,” which, in the U.S., is generally a disease or condition that affects fewer
than 200,000 individuals in the United States, or 200,000 or more individuals in the United States and for which there is no reasonable
expectation that the cost of developing and making a drug available in the United States for this type of disease or condition will be
recovered from sales of the product. Orphan drug designation must be requested before submitting an NDA. If a product that has an orphan
drug designation subsequently receives the first regulatory approval for the indication for which it has such designation, the product
is entitled to orphan exclusivity, meaning that the applicable regulatory authority may not approve any other applications to market the
same drug for the same indication, except in very limited circumstances, for a period of seven years in the U.S. Orphan drug designation
does not prevent competitors from developing or marketing different drugs for the same indication or the same drug for different indications.
After orphan drug designation is granted, the identity of the therapeutic agent and its potential orphan use are publicly disclosed. Orphan
drug designation does not convey an advantage in, or shorten the duration of, the development, review and approval process. However, this
designation provides an exemption from marketing and authorization fees.

Drugs manufactured or distributed pursuant to
FDA approvals are subject to continuing regulation by the FDA, including, among other things, requirements relating to recordkeeping,
periodic reporting, product sampling and distribution, reporting of adverse experiences with the product, and complying with promotion
and advertising requirements. The FDA may impose a number of post-approval requirements as a condition of approval of an NDA. For example,
the FDA may require post-market testing, including phase IV clinical trials, and surveillance to further assess and monitor the product’s
safety and effectiveness after commercialization. In addition, drug manufacturers and their subcontractors involved in the manufacture
and distribution of approved drugs are required to register their establishments with the FDA and certain state agencies and are subject
to periodic unannounced inspections by the FDA and certain state agencies for compliance with ongoing regulatory requirements, including
current Good Manufacturing Practices, which impose certain procedural and documentation requirements. Failure to comply with statutory
and regulatory requirements may subject a manufacturer to legal or regulatory action, such as warning letters, suspension of manufacturing,
product seizures, injunctions, civil penalties or criminal prosecution. There is also a continuing, annual prescription drug product program
user fee.

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The FDA may withdraw approval if compliance with
regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of
previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes,
or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information, requirements
for post-market studies or clinical trials to assess new safety risks, or imposition of distribution or other restrictions under a risk
evaluation and mitigation strategy.

Controlled Substances

The CSA and its implementing regulations establish
a “closed system” of regulations for controlled substances. The CSA imposes registration, security, recordkeeping and reporting,
storage, manufacturing, distribution, importation and other requirements under the oversight of the DEA. The DEA is responsible for regulating
controlled substances, and requires those individuals or entities that manufacture, import, export, distribute, research, or dispense
controlled substances to comply with the regulatory requirements in order to prevent the diversion of controlled substances to illicit
channels of commerce.

Facilities that manufacture, distribute, import
or export any controlled substance must register annually with the DEA. The DEA registration is specific to the particular location, activity(ies)
and controlled substance schedule(s). For example, separate registrations are needed for import and manufacturing, and each registration
will specify which schedules of controlled substances are authorized.

The DEA inspects all manufacturing facilities
to review security, recordkeeping, reporting and handling prior to issuing a controlled substance registration. The specific security
requirements vary by the type of business activity and the schedule and quantity of controlled substances handled. The most stringent
requirements apply to manufacturers of Schedule I and Schedule II substances. Required security measures commonly include background checks
on employees and physical control of controlled substances through storage in approved vaults, safes and cages, and through use of alarm
systems and surveillance cameras. Once registered, manufacturing facilities must maintain records documenting the manufacture, receipt
and distribution of all controlled substances. Manufacturers must submit periodic reports to the DEA of the distribution of Schedule I
and II controlled substances, Schedule III narcotic substances, and other designated substances. Registrants must also report any controlled
substance thefts or significant losses, and must obtain authorization to destroy or dispose of controlled substances. Imports of Schedule
I and II controlled substances for commercial purposes are generally restricted to substances not already available from a domestic supplier
or where there is not adequate competition among domestic suppliers. In addition to an importer or exporter registration, importers and
exporters must obtain a permit for every import or export of a Schedule I and II substance or Schedule III, IV and V narcotic, and submit
import or export declarations for Schedule III, IV and V non-narcotics.

For drugs manufactured in the United States, the
DEA establishes annually an aggregate quota for the number of substances within Schedules I and II that may be manufactured or produced
in the United States based on the DEA’s estimate of the quantity needed to meet legitimate medical, scientific, research and industrial
needs. The quotas apply equally to the manufacturing of the active pharmaceutical ingredient and production of dosage forms. The DEA may
adjust aggregate production quotas a few times per year, and individual manufacturing or procurement quotas from time to time during the
year, although the DEA has substantial discretion in whether or not to make such adjustments for individual companies.

Individual U.S. states also establish and maintain
separate controlled substance laws and regulations, including licensing, recordkeeping, security, distribution, and dispensing requirements.
State authorities, including boards of pharmacy, regulate use of controlled substances in each state. Failure to maintain compliance with
applicable requirements, particularly as manifested in the loss or diversion of controlled substances, can result in enforcement action
that could have a material adverse effect on the Company’s business, operations and financial condition. The DEA may seek civil
penalties, refuse to renew necessary registrations, or initiate proceedings to revoke those registrations. In certain circumstances, violations
could lead to criminal prosecution.

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9. Employees:

As of August 31, 2025, the Company had one employee,
our Director and CEO Eyal Barad, who residing in Israel.

Israeli labor laws principally govern the length
of the workday, minimum wages for employees, procedures for hiring and dismissing employees, determination of severance pay, annual leave,
sick days, advance notice of termination of employment, equal opportunity and anti-discrimination laws and other conditions of employment.
Subject to certain exceptions, Israeli law generally requires severance pay upon the retirement, death or dismissal of an employee, and
requires us and our employees to make payments to the National Insurance Institute, which is similar to the U.S. Social Security Administration.
Our employees have defined benefit pension plans that comply with applicable Israeli legal requirements, which also include the mandatory
pension payments required by applicable law and allocations for severance pay.

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