Item 2. Management’s
Discussion and Analysis of Financial Condition and Results of Operations.
Company Overview
The Company is a biopharmaceutical corporation
specializing in the discovery, development and commercialization of novel effective cannabinoid-based products and innovative technologies
for the treatment of cancer. Cannabics is a pioneer in the constellation of cannabis cancer and diagnostics. Our vision is to reveal
and personalize the potential of cannabis medicine to treat cancer itself, as well as side effects. We develop cancer diagnostics
in conjunction with cannabinoid medicine, utilizing novel bio-technological tools, striving to prevent cancer onset in healthy
adults and progression in patients. Personalization of cannabinoid-based treatments is the main scope of the company. We combine
the power of our proprietary technologies with the expertise of our leading scientists to unlock the medicinal properties of cannabis
and its diversity of bioactive compounds. We have conducted thousands of tests on biopsies and cell lines in order to identify
the physiologic impact of cannabinoids on cell cycle and cell death. This scientific workflow has generated an ongoing stream of
biological data through which we have accumulated in-depth knowledge of the various therapeutic effects of cannabinoids and identified
cannabinoid ratios demonstrating anti-tumor potential. We believe that our cannabinoid research coupled with our proprietary technologies
and intellectual property positions the Company to play an important role in the rapidly growing medical cannabis marketplace.
Our core technology is a continuously evolving
bioinformatics platform that utilizes high-throughput screening technology, advanced data analytics, and proprietary methodologies
to rapidly examine the physiologic effect of multiple cannabinoid compounds on tumor cells. This technology enables us to screen
thousands of cannabinoid combinations weekly, generating multiple datasets on the anti-tumor properties of different cannabinoid
formulations and ratios. We conduct a broad range of preclinical research on cannabinoids through our bioinformatics platform,
which informs the development of our product candidates.
Our lead product candidate is RCC-33, an
oral capsule for the treatment of colorectal cancer (“CRC”). RCC-33 contains high concentrations of the cannabinoids
CBDV and CBGA, which have demonstrated complex synergistic anti-tumor activity in our in vitro studies, with minimal
psychoactive effects. We are currently in the early planning stage of a clinical development pathway for RCC-33. We plan to conduct
further preclinical studies to establish the safety and efficacy of RCC-33 in an in vivo murine model of colorectal cancer.
Subject to the results of our preclinical studies, we intend to proceed to phase 1/2a clinical study in the second half of 2022.
Cannabics SR is a lipid-based capsule
containing a standardized formulation of cannabinoids that we are developing as a product candidate for the treatment of cancer
anorexia-cachexia syndrome (“CACS”). With a rapid onset of action and sustained effects for up to 6-8 hours, we believe
that the convenience of once or twice daily oral dosing of Cannabics SR may improve quality of life and increase patient compliance
with treatment regimens, leading to better health outcomes. A two-year pilot study of Cannabics SR led by Dr. Gil Bar-Sela
of the Rambam Hospital Health Care Campus, Division of Oncology, in Haifa, Israel, demonstrated a clinically significant weight
increase in CACS patients treated with Cannabics SR capsules (Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6785913/
). In the second half of 2021, we intend to commence an additional pilot study in Israel to assess the pharmacokinetics and pharmacodynamics
of Cannabics SR in humans. Data from the study will inform our clinical development plan for Cannabics SR. In the meantime,
we anticipate that the results of these studies may enable us to obtain a permit from the Israeli Ministry of Health to commercialize
Cannabics SR in Israel.
Another product candidate we are developing
is Cannabics CDx, a drug sensitivity test designed to provide innovative decision support to healthcare providers interested
in personalizing cannabinoid-based cancer therapies. Cannabics CDx applies data analytics and high-content drug sensitivity
screening integrated with our proprietary database to measure the effectiveness of cannabinoid compounds on a patient’s biopsy,
suggest preferred alternatives, and alert healthcare providers to cannabinoids that may be contraindicated. We believe that Cannabics CDx
will meet a significant unmet need of the growing population of cancer patients being treated with cannabis by enabling healthcare
providers to more precisely tailor cannabinoid treatments to a patient’s cancer and clinical profile. We are currently seeking
strategic partners for a clinical validation study expected to commence in 2022 to assess the sensitivity and specificity of Cannabics
CDx with a view towards commercializing Cannabics CDx in Europe, the United States, and other territories.
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 9.6 million deaths in 2018. As of January 1, 2019, there were more than 16.9 million people with a history of
cancer living in the United States, with 1.8 million new cases and 606,520 cancer deaths expected in 2020 (Source: American
Cancer Society. Cancer Facts & Figures 2020).
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).
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 1: 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 treatment of cancer.
Our Proprietary Bioinformatics Platform
We have developed a continuously evolving
preclinical bioinformatics platform that enables us to evaluate and classify the physiological impact of multiple cannabinoid compounds
on various cancer cells. Utilizing state-of-the-art high-throughput screening and flow cytometry, our platform is capable of testing
thousands of compounds weekly, allowing us to rapidly and effectively examine their interactions with a growing library of human
cancer cell lines and biopsies. Through the large body of data generated by our platform, we are accumulating in-depth knowledge
of the various therapeutic effects of cannabinoids and patterns of cannabinoid ratios that demonstrate meaningful physiologic impact
on cancer.
Our bioinformatics platform includes the
following:
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high-throughput screening, high content screening, flow cytometry, machine learning, robotics, and proprietary methodologies;
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a library of human cancer cell lines and thousands of different combinations and ratios of cannabinoid compounds in a costumed matrix;
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a growing database of biological response data;
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in-house extraction, processing methodologies, and analytical techniques that yield well-characterized and standardized extracts;
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collaborations with regulated cannabis producers that may expand our cannabinoid compound library and provide us with access for future proprietary cultivars;
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fully integrated in-house research and development; and
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regulatory expertise.
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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.
Biopharmaceutical Collaboration
As medical cannabis
becomes increasingly recognized for its therapeutic potential in the age of personalized medicine and genomics, we believe that
there is a growing global demand by biopharmaceutical companies for research and diagnostic tools that both facilitate and accelerate
the generation of biological information for the development of cannabinoid drugs and formulations. We believe that our bioinformatics
platform will be of benefit to such companies and may therefore represent collaborative opportunities, market potential and downstream
value-creation for the Company.
Finding novel
ways to treat and cure diseases is a fundamental challenge in biomedical research. Unsuccessful clinical trials are the most expensive
obstacle for drug development because of the immense costs and the low success rate. Only 1 out of 10 drugs successfully pass through
clinical development, with 80% of drugs excluded before Phase 3 clinical trials (Source: Biotechnology Innovation Organization,
“Clinical Development Success Rates, 2006-2015). The low clinical target validation success rate reflects a lack of reliable
drug target prediction methods. This is particularly true in the case of research on cancer, which is increasingly being understood
as not just many but thousands of different diseases, requiring more well-defined targets and biomarkers. A 2018 study by MIT found
that trials using biomarkers for patient stratification have higher success rates, especially in the area of oncology, where clinical
trials using biomarkers exhibited almost twice the overall probability of success compared to trials without biomarkers (Source:
Biostatistics, 2019;20(2):273-286).
We believe that
our bioinformatics platform could make the development of cannabinoid-based drugs more successful by providing a more accurate
and reliable drug target prediction method. Our proprietary analytics may benefit biopharmaceutical companies across a range of
applications, including patient selection and recruitment for clinical trials and identification of new targets for drug development.
Development Pipeline
We are currently developing a portfolio
of proprietary technologies and formulations with a variety of research, analytic, and therapeutic applications. Our most advanced
development programs include the following:
Product Candidate
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Indication/Description
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Current Development Status
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Expected Next Steps
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Partner(s)
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RCC-33
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Colorectal Cancer
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Pre-clinical
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Pre-IND meeting with FDA in the second half of 2021.
Phase 1/2a clinical trial expected to commence in
the second half of 2022
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None
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Cannabics SR
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Cancer Anorexia-Cachexia Syndrome
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Phase 0
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Additional pilot studies expected to commence in the second half of 2021
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None
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Cannabics CDx
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Drug sensitivity test for cannabinoid-based cancer therapies.
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Pre-clinical
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Clinical validation study to commence in 2022
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To be determined
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We continue to conduct research and seek
collaborations for new advances in biotechnology that may lead to the development of additional product candidates.
RCC-33 for Colorectal Cancer
Overview
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 1,348,087 people living with CRC in 2017 (Source: National Cancer Institute. “Cancer Stat Facts:
Colorectal Cancer”). It is estimated that 147,950 Americans will be diagnosed with CRC in 2020, representing 8.2% of
all new cancer cases, and 53,200 Americans will die from the disease (Source: American Cancer Society. “Cancer Facts &
Figures 2020”).
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 2017-2019”). 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. 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”).
Cannabinoids and Colorectal Cancer
A new emerging area of scientific understanding
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 and can confirm absolutely 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 2: Synergistic
effects of different cannabinoid combinations on viability of a colon cancer cell line.
RCC-33
We are developing RCC-33 as an oral capsule
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.
Development Plan
We are currently in the early planning
stage of a clinical development pathway for RCC-33. We plan to conduct further preclinical studies to establish the safety and
efficacy of RCC-33 before proceeding with first-in-human clinical testing. LAST PR RE FDA PRE-IND STUDIES – TALK ABOUT SCALPA
Preclinical Studies
We have now written and shall shortly begin
a proof of concept non-clinical study in a murine model for colon adenocarcinoma to validate the results obtained in our cell-based
assays. In addition, 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 fourth quarter of 2020, will guide our planned Phase 1/2a clinical trial. The non-clinical requirements to
support the development program will be verified with the FDA at a pre-IND meeting expected to take place in the second half of
2021. 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 RCC-33 in a Phase 1/2A ascending dose clinical trial in CRC patients, commencing in the second
half of 2022. 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 1/2a human proof of concept study, which is estimated to cost $1,000,000. We believe that the Company’s
currently available funds will be sufficient to obtain all regulatory approvals necessary to conduct the Phase 1/2a trial. As at
the date of this filing, however, the Company does not have sufficient funds to complete the Phase 1/2a study.
Subject to the results from our Phase 1
trials, we plan to submit an IND to the FDA for RCC-33 with the clinical protocol for a Phase 2 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
2 human proof of concept trial will inform our decision regarding further steps in the clinical development of RCC-33.
At this time, we do not expect to independently
develop RCC-33 up to regulatory approval. Instead, we plan to seek a pharmaceutical partner or partners to continue our commercialization
efforts. However, we may also seek to further advance the RCC-33 program with additional human clinical trials prior to finding
a suitable pharmaceutical partner or partners. We estimate that it will take more than five years to bring RCC-33 to market, if
at all, at a cost of more than $10 million.
Cannabics SR for Cancer Anorexia-Cachexia
Syndrome
Overview
At the same time,
we are pursuing our work on colorectal cancer, we are continuing our development of 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.
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.
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.
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.
Patients were administered 2 × 10
mg of Cannabics SR per 24 hours for six months. Participants were weighed at each physician visit. The primary objective of
the study was a weight gain of ≥10% from baseline. Despite various limitations, the preliminary study demonstrated a weight
increase of 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.)
We intend to conduct additional pilot studies
in Israel to assess the pharmacokinetics and pharmacodynamics of Cannabics SR in humans. These studies are expected to commence
in 2021 at an anticipated cost of $250,000. Data from the pilot studies will guide our decisions regarding further clinical development
and may better inform the design of our anticipated Phase 1 trials.
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.
If we are granted such a permit, we intend to engage a GMP manufacturer in Israel to produce Cannabics SR capsules for national
medical distribution.
Cannabinoids and Personalized Medicine
While preclinical
research during the last decade has stimulated interest in the therapeutic potential of cannabinoid compounds in oncology, one
of the challenges facing healthcare providers and patients in selecting a cannabinoid based therapy has been the diversity of the
cannabis plant, which encompasses thousands of distinct profiles, each with its own chemical composition and effects. After decades
of highly restrictive regulation, there is presently a lack of clinically relevant information as to which cannabinoids are best
suited to the unique medical needs of a patient across multiple lines of therapy. The result has left healthcare providers and
patients at a loss as to which cannabinoids may be best suited to treat the unique cancer profiles of individual patients.
Cannabics CDx
We believe that
the success of personalized medicine depends on the development of accurate and reliable diagnostics. Our goal is to expand the
scope of personalized medicine across the cancer care continuum to include cannabinoid-based therapies and enable clinicians to
make better informed decisions leading to improved clinical outcomes and lower healthcare costs. To that end, we are developing
Cannabics CDx as a product candidate to provide clinical decision support data to healthcare providers interested in personalizing
cannabinoid-based cancer therapies. We believe that by making cannabinoid therapy selection more accurate and accessible, Cannabics
CDx may play a significant role in ushering medical cannabinoids into the mainstream of oncology.
Cannabics CDx
is an innovative drug screening system that measures the effectiveness of cannabinoid compounds on a patient’s biopsy, identifies
alternatives, and alerts healthcare providers to cannabinoids that may be contraindicated. Biopsied samples are delivered by courier
to our laboratory, where we perform novel cannabinoid sensitivity tests on them using our high-content drug sensitivity screening
integrated with our bioinformatics platform. We then apply advanced analytics to the test results and other relevant biological
and clinical information provided by each patient’s healthcare provider to derive clinical support data from which healthcare
providers can make better informed treatment decisions.
Figure 4:Sample
personalized patient report produced by Cannabics CDx
By enabling healthcare providers to more
precisely tailor cannabinoid therapies to a patient’s cancer and clinical profile, we believe that Cannabics CDx will
meet a significant unmet need of the growing population of cancer patients being treated with cannabis.
Validation
We are currently planning a clinical validation
study expected to commence in 2022 to assess the sensitivity and specificity of Cannabics CDx. We are currently seeking strategic
partners to collaborate on the validation and commercialization process.
Intellectual Property
Our success depends in significant part
on our ability to protect the proprietary nature of our Product Prospects, technology and know-how, to operate without infringing
on the proprietary rights of others; and to defend challenges and oppositions from others and prevent others from infringing on
our proprietary rights, including our provisional patents described below.
We plan to continue to seek patent protection
in the United States and other countries for our proprietary technologies. To date, our intellectual property portfolio includes
three provisional patents, filed with the USPTO, related to our line of activity (pharmaceutical formulations; drug delivery; therapeutic
uses of cannabinoids and other cannabis compounds and personalized cannabinoid diagnostics), as well as know-how and trade secrets.
A full list of our IP applications in all countries can be found in our Annual 10-K filing of November 4, 2020 at page 25.
Results of Operations
For the Three Months Ended November 30, 2020 and 2019
Revenues
We have not received royalties during
the three months ended November 30, 2020 due to the termination of the royalties agreement, compared to $1,754 for the three months
ended November 30, 2019. The reason for the decrease in revenues is due to the termination of our relationship with the licensee.
Operating Expenses
For the three months ended November 30,
2020 our total operating expenses were $659,732 compared to $817,610 for the three months ended November 30, 2019 resulting in
an decrease of $157,878. The decrease is attributable to decrease of $108,009 in general administration expenses and a total decrease
of $49,869 in research and development expenses, and sales and marketing expenses.
We incurred a financial income of $4,965
for the three months ended November 30, 2020, compared to financial expense of $4,326,339 for the three months ended November 30,
2019. The decrease in financial expense was mainly attributable to revaluation of a financial asset of $4,363,000. This revaluation
relates to our Company’s investment in Seedo Corp., which is obligated by the afore-mentioned sum in future royalties. Subsequent
to November 30th, 2019, but prior to the date of this filing, the Company was made aware of a Petition for Debt Settlement
filing by E-Roll Grow Tech Ltd., the fully owned subsidiary of Seedo Corp. Said filing calls into question the ability of Seedo
Corp. to fulfill its royalty obligations to us. This accounting treatment does not release Seedo from its obligations under the
agreement. As such, the Company has removed its anticipated Royalties for accounting purposes from Seedo at this time. As a result,
the net loss was $654,767 for the three months ended November 30, 2020 compared to $5,141,195 for the three months ended November
30, 2019.
Net loss
Net loss decreased by $4,487,428 to $654,767
for the three months ended November 30, 2020, compared to a net loss of $5,142,195 for the three months ended November 30, 2019.
Liquidity and Capital Resources
Overview
As of November 30, 2020, we had $184,031
in cash compared to $319,344 on November 30, 2019. We expect to incur a minimum of $1,000,000 in expenses during the next twelve
months of operations. We estimate that these expenses will be comprised primarily of general expenses including overhead, legal
and accounting fees, research and development expenses, and fees payable to outside medical centers for clinical studies.
Liquidity and Capital Resources during
the Three Months Ended November 30, 2020 compared to the Three Months Ended November 30, 2019
We used cash in operations of $592,637
for the three months ended November 30, 2020 compared to cash used in operations of $761,687 for the three months ended November
30, 2019. The negative cash flow from operating activities for the three months ended November 30, 2020 is primarily attributable
to the Company's net loss from operations of $654,767, a decrease in accounts payables and accrued liabilities of $12,100 and an
increase of $16,275 in account receivables and prepaid expenses. Offset by depreciation of $57,505 and shares issued for services
of $33,000.
We had cash flow from investing activities
of $943 during the three months ended November 30, 2020, compared to $815,049 cash flow from investing activities for the three
months ended November 30, 2019. The reason for the decrease in cash flow from investing activities is primarily due to the purchase
of fixed assets in an aggregate amount of $934, for the period ended November 30, 2020, and realization of held for trading shares
in the aggregate amount of $824,849 for the period ended November 30, 2019.
We will have to raise funds to pay for
our expenses. We may have to borrow money from shareholders, issue equity or enter into a strategic arrangement with a third party.
There can be no assurance that additional capital will be available to us. We currently have no arrangements or understandings
with any person to obtain funds through bank loans, lines of credit or any other sources. Since we have no such arrangements or
plans currently in effect, our inability to raise funds for our operations will have a severe negative impact on our ability to
remain a viable company.
Going Concern
Due to the uncertainty of our ability to
meet our current operating and capital expenses, our independent auditors included an explanatory paragraph in their report on
the audited financial statements for the year ended August 31, 2020 regarding concerns about our ability to continue as a going
concern. Our financial statements contain additional note disclosures describing the circumstances that lead to this disclosure
by our independent auditors.
Our unaudited financial statements have
been prepared on a going concern basis, which assumes the realization of assets and settlement of liabilities in the normal course
of business. Our ability to continue as a going concern is dependent upon our ability to generate profitable operations in the
future and/or to obtain the necessary financing to meet our obligations and repay our liabilities arising from normal business
operations when they become due. The outcome of these matters cannot be predicted with any certainty at this time and raise substantial
doubt that we will be able to continue as a going concern. Our unaudited financial statements do not include any adjustments to
the amount and classification of assets and liabilities that may be necessary should we be unable to continue as a going concern.
There is no assurance that our operations
will be profitable. Our continued existence and plans for future growth depend on our ability to obtain the additional capital
necessary to operate either through the generation of revenue or the issuance of additional debt or equity.
Off-Balance Sheet Arrangements
We currently have no off-balance sheet
arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, changes
in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.
Critical Accounting Policies
The preparation of financial statements
in conformity with accounting principles generally accepted in the United States of America requires us to make a number of estimates
and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities
at the date of the financial statements. Such estimates and assumptions affect the reported amounts of revenues and expenses during
the reporting period. We base our estimates on historical experiences and on various other assumptions that we believe to be reasonable
under the circumstances. Actual results may differ materially from these estimates under different assumptions and conditions.
We continue to monitor significant estimates made during the preparation of our financial statements. On an ongoing basis, we evaluate
estimates and assumptions based upon historical experience and various other factors and circumstances. We believe our estimates
and assumptions are reasonable in the circumstances; however, actual results may differ from these estimates under different future
conditions.
See Item 7, “Management’s Discussion
and Analysis of Financial Condition and Results of Operations” and Note 2, “Summary of Significant Accounting Policies”
in our audited consolidated financial statements for the year ended August 31, 2020, included in our Annual Report on Form 10-K
as filed on November 4, 2020, for a discussion of our critical accounting policies and estimates.