Item 1. Description of
Business
We were previously an exploration stage mining
company which has transitioned now into a bio-tech company. We currently have an IP Licensing Agreement in Spain, and the USA,
but have not as yet earned revenues. We can provide no assurance that we will be able to successfully license our technology or
that said licensing agreements will be commercially viable.
Our Address corporate address is #3 Bethesda
Metro Center, Suite 700, Bethesda, Maryland, 20814; Telephone (877) 424-2429.
The company was previously engaged in the
oil and gas exploration business. On April 29th, 2014, the company began a new direction and the majority of the Shareholders
of the company elected the current Board of Directors and renamed the Company Cannabics Pharmaceuticals Inc. The Directors form
a US based company founded in 2012 by a group of renowned researchers from the fields of molecular biology, cancer research and
pharmacology. R&D is conducted in Government licensed labs in Israel with the focus of development of novel and sophisticated
cannabinoid based therapies, medications and administration routes for various diseases.
History
Cannabics Pharmaceuticals Inc. was incorporated
on September 15, 2004, under the laws of the State of Nevada, as Thrust Energy Corp., for the purpose of acquiring undivided working
interests in small oil and gas exploration properties and non-operating interests in both producing and exploration projects throughout
the United States and Canada.
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 5th, 2011, we effected a change of name to American Mining
Corp. by completing a short form merger with a wholly-owned subsidiary.
On April 25th, 2014, Cannabics Inc., a Delaware
Corporation, purchased 20,500,000 shares of restricted stock of the Company, thus acquiring control of the company.
On April 29th, 2014, Mr. Andrew Grundman resigned
his official position as Director of the Corporation. On April 29th, 2014, the shareholders of the Corporation voted Dr. Zohar
Koren, Dr. Eyal Ballan and Itamar Borochov as the new Directors of the Company.
Dr. Zohar Koren resigned his official position
as director of the corporation on January 2015.
On June 3rd, 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.
On June 19th, 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 Cannabics 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, Cannabics 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 Cannabics Pharmaceuticals Inc.
On July 24th, 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 July 31st, 2014, Cannabics Pharmaceuticals
Inc. filed its exclusive Patent Application with the US Patent & Trademark Office (USPTO), which covers the proprietary technology
developed by its team of experts in the field of cannabinoid long acting lipid based formulations. This patent is the basis for
the company’s “CANNABICS SR” technology, which consists of the IP for standardized and long acting medical cannabis
capsules, designed for patients suffering from diverse indications. Simultaneously this Patent was filed with the PCT division
of the Israeli Patent Office (ILPO) in order to provide International IP protection.
On August 25th, 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 December 18th, 2014, Cannabics Pharmaceuticals
Inc. executed a letter of engagement with Mountain High Products in Colorado, for the manufacturing and distribution of Cannabics
SR technology in the Colorado market. Cannabics SR medical cannabis technology will be utilized by Mountain High Products in strict
compliance with Colorado laws and regulations of "Cannabis Infused Edible Products" and distributed to certified dispensaries
through Mountain High's existing distribution channels.
On January 29, 2015 the Company executed an
Agreement with Rambam Medical Center (Israel) to undertake a controlled pilot study utilizing Cannabics SR Capsules as palliative
treatment to improve cancer related Cachexia and Anorexia Syndrome in advanced stage cancer patients. Rambam is a world renowned
academic hospital acknowledged for their cutting-edge research projects and integration of innovative new therapies and treatments
to over 2 million residents of Northern Israel. You can view the details of this ongoing study from the NIH website at http://www.cancer.gov/clinicaltrials/search/view?cdrid=769090&version=HealthProfessional&protocolsearchid=12509449.
On February 15, 2015 the Company executed of
a Research Agreement with the Technion Research & Development Foundation Ltd (Israel) to undertake a Research Project entitled
"
The Assessment of the Antitumor Activity of the Whole Cannabis Plant Extract, Components and Derivatives Thereof".
The Research Project is scheduled to last one calendar year. Under the terms of the Agreement, Cannabics Pharmaceuticals will collaborate
under the supervision of Prof. Dedi Meiri, Head of Technion’s Laboratory of Cancer Biology and Cannabinoid Research. The
purpose of this Research is to develop a diagnostic and therapeutic system to harness the anti-cancer properties of active cannabis-based
ingredients. The study will screen and evaluate different types of human cancer cells treated with a multitude of cannabinoid combinations
and observe and catalogue the effects thereof. Technion is consistently ranked among the world’s top science and Technology
Research Universities. The Faculty of Biology is comprised of 23 independent research groups, focusing on a variety of aspects
of Cellular, Molecular and Developmental Biology. The faculty has extensive collaborations with the pharmaceutical and biotechnology
industries.
On May 27th, 2015 the Company filed a Patent
with the USPTO entitled “
A Method of in Vitro High Throughput Screening of Cancer Biopsies with Cannabinoid Extracts
”.
In essence this patent takes the next step from the cancer cell knowledge already obtained from cell lines in the Technion Laboratory
and extends it to a system of analyzing cancer cells taken from patient biopsies, and then testing them against a multitude of
cannabinoid combinations for anti-tumor activity via the High Throughput Screening process. This patent formally begins the next
phase of the Company, which is Personalized Medicine (PM). We have developed an automated high-throughput method for the screening
of different types of cancer cells or biopsies treated with a multitude of cannabis extracts. These natural extracts could also
be tested in conjunction with already approved and common synthetic drugs for patients that undergo chemotherapy for the most
personally tailored therapy. This multilayer method is producing a large-scale database that will capture the knowledge gained
as to the unique effects of different combinations of cannabinoid compounds on diverse malignancies. Coextensive with the development
of the automated high-throughput system, we are also developing proprietary and novel compounds targeting diverse and specific
types of tumors.
On January 25th 2016 Cannabics Pharmaceuticals
Inc. executed an exclusive IP Licensing Agreement with Mountain High Products LLC and the Cima Group LLC for the production and
distribution of the Company’s CANNABICS SR technology of medical cannabis capsules in Colorado. And with, Cima Group LLC
which is a related party to mountain high and is charged with their operations in states outside of Colorado.
On February 24, 2016, the Company filed a new
patent application for the company’s slow release medical capsules with the US Patent & Trademark Office, as noted in
their Press Release of that date.
On March 22nd, 2016, the Company announced
the start of a regulated Clinical Study for Cancer Patients in Israel under the auspices of the Rambam Medical Center and the
Ministry of Health. This clinical study involves patients with advanced cancer and cancer anorexia cachexia syndrome (CACS), endpoints
examined are weight gain appetite, quality of life and a marker for anti-cancer activity. Quality of life in patients with CACS
is directly related to loss of appetite and loss of weight. This study examines the influence of Cannabics Pharmaceuticals SR
capsules on both of these common effects of cancer and cancer treatment. Secondary outcome measures are improvement in appetite,
reduction in TNF-alpha level, safety assessment for early psychiatric side-effects, quality of life and evaluation of muscle strength.
While this study is taking place in Israel, it is fully registered with the US NIH under
"Cannabics Capsules as Treatment
to Improve Cancer Related CACS in Advanced Cancer Patients",
Identifier NCT02359123, and may be found at https://clinicaltrials.gov/ct2/show/NCT02359123.
On June 6
th
, 2016 the Company filed
a PCT Application with the US Patent & Trademark Office (USPTO) entitled a "System and Method for High Throughput Screening
of Cancer Cells". Cannabics Pharmaceuticals has developed a proprietary high throughput screening process which is designed
to generate mega-data of specific cannabinoids and cannabinoid formulations with antitumor properties. In this proprietary process
biopsies and live cancer cells lines are treated, In vitro, with innumerous combinations of cannabinoids and the resulting antitumor
effects are screened, categorized and actually visually displayed.
Our Business
We are a pharmaceutical development company
focusing on cancer research utilizing advanced HTS technology and personalized bioinformatics tools.
Management Experience
Cannabics Pharmaceuticals
Inc.’s management team is highly experienced in various aspects of biotech and pharmaceutical management. The scientific
team has a long cumulative track record in cancer and CNS research, pharmaceutical development, clinical studies and a deep hands-on
understanding of the medical cannabis industry.
Dr. Eyal Ballan, 43,
is a co-founder of Cannabics Inc. and is its CTO. Dr. Ballan holds a Ph.D. in Neurophysiology, EEG, Brain Wave Analysis and Cortical
Connectivity. After obtaining his Ph.D. he was an entrepreneur in the field of Biofeedback Studies and developed a Resonating Neuro-Feedback
system. Dr. Ballan holds a M.Sc. from Tel-Aviv University - Magna Cum Laude - in anticancer drug development. Dr. Ballan was
part of the renowned research team which developed Salirasib (Treatment for Non-Small Cell Lung Cancer). He is an expert
in molecular biology, cell cultures and genomics with a focus towards identification of anticancer compounds and delivery systems
to tumors and is a member of the American Academy of Neurology.
Itamar Borochov, 57, is a co-founder of Cannabics
Inc. and is its Chief Executive Officer. Mr. Borochov is an environmentalist with experience as an entrepreneur in the fields of
organic agriculture and medical botanicals and brings vast expertise in the areas of market intelligence and organizational branding.
All the Directors are committed full time to
the Company.
Advisory Board –
Dr. Sigalit Ariely-Portnoy - Senior Advisor
in the field of Regulation, Validation and Quality. Dr. Sigalit Ariely-Portnoy has over 17 years’ experience in the pharmaceutical
industry. During this time, she has managed pharmaceutical and chemical plants at Taro pharmaceutical industries Ltd as Operation
Group Vice president and in Teva Pharmaceutical industries Ltd as Kfar-Saba OSD plant manager. Dr. Ariely-Portnoy managed Teva's
largest plant worldwide (9 billion tablets per annum and more than $2B revenues). During her career, she led more than 50 inspections
by the US FDA, EMEA, Israeli MOH, and others. Dr. Ariely-Portnoy spearheaded the construction of a 200,000 sq ft pharmaceutical
plant, several chemical plants and bio-warehouses, as well as many significant plant expansions for manufacturers of semisolids,
liquids and oral solid dosage forms. Between the years 2003-2006, Dr. Ariely-Portnoy was the president of the Israel chapter of
the PDA (Parenteral Drug Association). For the last 5 years, Dr. Ariely-Portnoy manages Gsap, a company which consults pharmaceutical,
medical device and biotechnology companies in several major fields, including innovative product development, regulation, establishing
quality systems and validation services. Dr. Ariely-Portnoy received her B.Sc., M.Sc., and D.Sc. from the Technion Institute of
Technology in Haifa, Israel, in the fields of Chemical Engineering and Biomedical Engineering.
Company Overview –
CANNABICS PHARMACEUTICALS, INC. is based in
Bethesda, Maryland, and is dedicated to the development and licensing of advanced and sophisticated cannabinoid-based treatments
and therapies. The Company’s main focus is development and marketing of various new and innovative therapies and biotechnological
tools aimed at providing relief from diverse ailments that respond to active ingredients sourced from the cannabis plant. These
advanced tools include innovative delivery systems for cannabinoids, personalized medicine therapies and procedures based on cannabis
originated compounds and bioinformatics tools.
The parent Company Cannabics Inc was founded
by a group of Israeli researchers from the fields of cancer research, pharmacology and molecular biology. Its current flagship
Intellectual Property is named “CANNABICS SR”, a proprietary formulation to create a long acting medical cannabis capsule
that was shown in observational studies in Israel to provide 10-12 hours of beneficial therapeutic effects and indicated initially
as a palliative care therapy for cancer patients. This proprietary delivery method enables a convenient once per day dosing regimen
of medical cannabis to patients.
The Company has a dedicated team of scientists
that are working constantly on creating new technologies of medical cannabis care for patients in diverse indications. The company’s
Research is located in Israel which has allowed for the use of medical cannabis since the 1990s, and has a favorable regulatory
attitude towards the conducting of Cannabis based clinical studies in Israeli hospitals – in contrast to the legal situation
in the United States where clinical research on medical cannabis is still illegal. This structure is an extraordinary corporate
advantage, and markedly separates the company from similarly minded companies.
The number of people licensed to receive medical
cannabis treatment in Israel numbers around 20,000 - in comparison to over 1,000,000 in the whole of the United States. Therefore,
while the Israeli market potential is regarded as limited, the ability to perform clinical studies and use the Israeli market as
an “advanced medical Cannabis R&D lab” is proving to be highly advantageous.
Most importantly, while the U.S. FDA has yet
to approve even basic private research relating to cannabis, the regulatory environment is quite different in Israel. Within the
Israeli Ministry of Health, there is a stand-alone agency, the Israeli Medical Cannabis Agency, (IMCA), which on October 26th, 2014, granted Cannabics Pharmaceuticals an exclusive government License to launch their advanced scientific R&D program.
Through the large body of research that is
conducted by its scientists and affiliated partners, the Company has been able to gain in-depth knowledge of the various therapeutic
effects of diverse cannabis strains and identify patterns of cannabinoid ratios that are useful in treating various indications.
The Company is currently in the midst of several collaborative programs with several leading academic research and medical centers
in Israel in order to further establish the beneficial therapeutic effects of its proprietary Intellectual Property, and to refine
its development of novel treatments for debilitating ailments.
CANNABICS SR technology
While the medicinal effects of certain cannabinoids
are well known to physicians, it is common knowledge that smoking is hazardous to health, due to the formation of inhaled carcinogenic
compounds in the combustion process and deposit of tar and other damaging residues in the lung tissue. Many physicians are perfectly
aware of the beneficial therapeutic properties of medical cannabis, however they refrain from recommending or prescribing it to
patients knowing that smoking the raw flowers is still the most common and available administration route. Suggesting smoking for
a grandmother going through cancer treatment makes little sense. Hence the availability of an oral, standardized, reliable and
clinically tested administration route of medical cannabis – no different from the administration route of most medications
consumed by patients today - would dramatically improve the availability of medical cannabis therapy to patients in need.
Standardization and reproducibility
Most practicing physicians are aware of the
increasing market availability of cannabis edible products such as cannabis cookies, chocolates and chewing gums. However, these
products have so far totally failed in gaining credibility in the eyes of the medical community due to a severe lack in standardization
and reproducibility. Laboratory tests of cannabinoid concentrations in currently available edible products have demonstrated severe
variability in the potency of those products, due to non-uniformity of manufacturing procedures in the kitchens that produce them.
In addition, the bioavailability levels (the amount of active ingredients that ultimately reach the blood stream after ingestion)
of these products is also highly variable due to the lack of a standardized and efficient formulation. As a result, it is very
common to either over-dose or under-dose when using such cannabis edibles as a therapeutic means, a fact which rightly prevents
most physicians from recommending these medically un-tested products. Therefore, a substantial unmet need of the medical cannabis
market is a standardized and reproducible product, which is based on a sophisticated and advanced formulation that provides a high
and predictable bioavailability level of the cannabis active ingredients to patients.
Long lasting and stable effect profile
An additional substantial drawback of most
currently available administration routes of medical cannabis is the short lasting effect profile that they offer, with a typical
3-4 hour effect for smoking, vaporizing and sublingual administration, and a typical 6-7 hour effect for unformulated edible products.
As a result, the patient has to re-dose several times throughout the day, and suffers from inconsistent and rapidly variable levels
of therapeutic effects. Many patients and physicians report that this is one of the main limitations to the efficacy of currently
available medical cannabis therapies, and a major cause for a sub-optimal treatment. Therefore, a substantial unmet need in the
medical cannabis field is a long acting product that will provide a steady state level of therapeutic effects for at least 10 hours,
and can thus allow a whole day of beneficial response within the therapeutic window upon a once-per-day dosing regimen.
Cannabics Pharmaceuticals Inc. has developed
its proprietary “CANNABICS SR” long acting formulation in order to address these specific unmet needs of medical cannabis
needs described above. This sophisticated and advanced formulation is the core technology embedded in CANNABICS SR. Our technology
allows for standardized and long acting medical cannabis dosage, designed for specific and various indications. The proprietary
formulation ensures the patient experiences a constant, steady state level of beneficial effects within the therapeutic window
for up to a 10 – 12 hour span. The unique long acting formulation allows for once-per-day dosing regimen that provides the
desired therapeutic effects of medical cannabis throughout the day. Thus, our technology enables a safe, effective and reproducible
administration method and fulfils the unmet needs of both patients and physicians.
The Cannabics SR technology perfectly solves
one of the major concerns of medical cannabis patients, which is the initial high peak of active cannabinoids concentration in
the plasma soon after administration. This high peak is a common feature of immediate release cannabis administration methods,
and can cause undesirable side effects such as disorientation and dizziness. The unique pharmacokinetic profile of our technology
helps to avoid this undesired result. The CANNABICS technology assumes only natural pure extracts of active cannabinoids from specifically
selected strains of medical cannabis, that are carefully chosen to serve the unique needs of patients suffering from specific indications.
There are no synthetic compounds involved. The CANNABICS technology is pre-designed to fit the currently existing medical cannabis
regulations in Israel, Europe and certain US States which are licensed as a “Medical Marijuana Infused Products Manufacturer”
(§12-43.3-404 CRS). The ingredients used in the proprietary CANNABICS SR formulation are all certified food grade ingredients
(recognized by the FDA as “G.R.A.S.” – Generally Regarded as Safe) and the formulation is free of any artificial
additives or chemical substances. Thus the CANNABICS SR technology is fully compliant with the current cannabis infused edible
product regulatory definition, which is in fact very similar to a regular food supplement regulatory definition.
As a result, CANNABICS technology is exempt
from long and arduous pharmaceutical development processes and does not require additional regulatory approval beyond the standard
“Medical Marijuana Infused Products Manufacturer” license from a licensee (the “manufacturer”) in order
to reach the market. This unique position distinguishes CANNABICS SR technology from other options currently available in the market.
On the one hand, the technology proffers a fully standardized and reproducible product that has compliance for GMP manufacturing
standards just as one would expect from any pharmaceutical product; and on the other hand it is pre-designed to allow for use of
this technology without long, arduous and extremely expensive regulation processes that are typical in the pharmaceutical industry.
In order to establish the goal of true standardization
and reproducibility and to indeed rank as one of the leading medical cannabis technologies in the market, Cannabics Pharmaceuticals,
Inc. has achieved Good Manufacturing Practices (GMP) capabilities. GMP regulations are designed to ensure that products are produced
and controlled according to the highest industry quality standards. Adhering to these practices ranks Cannabics among a very limited
number of medical cannabis technologies available in the market that are capable of being manufactured according to GMP standards.
An additional goal of the company is to be one of the first and few companies in the world to commercialize its clinically tested
cannabis-based technology. In furtherance of this goal, Cannabics Inc. has now undertaken a series of clinical studies in renowned
medical centers in Israel where the R&D division is strategically located. Achievement of GMP manufacturing capabilities is
an important pre-requisite for the initiation of these clinical studies. The efficacy and safety data collected in these formal
clinical studies, together with the superior pharmacokinetic profile of the Cannabics SR formulation, will be the key advantage
of Cannabics in the medical cannabis arena.
Cannabics Pharmaceuticals Inc. has now initiated
its technology through a strategic partner in the state of Colorado and EU markets under existing medical cannabis regulatory pathways,
while simultaneously preparing to launch a series of formal clinical studies in order to establish the unique medical benefits
of its technologies for patients suffering from various indications.
The company’s business model is solely
based on technology development and IP out-licensing to licensed and certified producers for marketing. The Company’s technologies
are licensed to a strategic partner in compliance with each country’s and/or US state’s statutory regulations and exclusively
to licensed and authorized medical cannabis local licensees that have adequate production and marketing capabilities. Within the
US, Cannabics Pharmaceuticals Inc. itself
does not
manufacture, distribute, dispense or possess any controlled substances,
including cannabis or cannabis based preparations, it merely licenses its IP. Within Israel, Europe and other territories outside
the US, Cannabics Pharmaceuticals Inc. may employ a different business model through gaining adequate licenses under the appropriate
regulations in each territory, all in full compliance with local rules and regulations in each country. Cannabics Pharmaceuticals
Inc. is purely a Bio-Technology Pharmaceutical company which licenses use of its Intellectual Property, it does not itself produce
or provide any product in any location.
Intellectual Property
On July 31, 2014, the Company filed an exclusive
Patent Application with the US Patent & Trademark Office (USPTO), which covers the proprietary technology developed by its
team of experts in the field of cannabinoid long acting lipid based formulations. This technology is the basis for the company’s
“CANNABICS SR” technology, which is the basis of a standardized and long acting medical cannabis capsules, designed
for patients suffering from diverse indications. Simultaneously a Patent Application was filed with the PCT division of the Israeli
Patent Office (ILPO) in order to provide International IP protection.
On May 27th, 2015 the Company filed a Patent
with the USPTO entitled “
A Method of in Vitro High Throughput Screening of Cancer Biopsies with Cannabinoid Extracts
”.
In essence this patent takes the next step from the cancer cell knowledge already obtained from cell lines in the Technion Laboratory
and extends it to a system of analyzing cancer cells taken from patient biopsies, and then testing them against a multitude of
cannabinoid combinations for anti-tumor activity via the High Throughput Screening process. This patent formally begins the next
phase of the Company, which is Personalized Medicine (PM). We have developed an automated high-throughput method for the screening
of different types of cancer cells or biopsies treated with a multitude of cannabis extracts. These natural extracts could also
be tested in conjunction with already approved and common synthetic drugs for patients that undergo chemotherapy for the most
personally tailored therapy. This multilayer method is producing a large-scale database that will capture the knowledge gained
as to the unique effects of different combinations of cannabinoid compounds on diverse malignancies. Coextensive with the development
of the automated high-throughput system, we are also developing proprietary and novel compounds targeting diverse and specific
types of tumors.
On February 24, 2016, the Company filed a new
patent application for the company’s slow release medical capsules with the US Patent & Trademark Office, as noted in
their Press Release of that date.
On June 6th, 2016 the Company filed a PCT
Application with the US Patent & Trademark Office (USPTO) entitled a "System and Method for High Throughput Screening
of Cancer Cells". Cannabics Pharmaceuticals has developed a proprietary high throughput screening process which is
designed to generate mega-data of specific cannabinoids and cannabinoid formulations with antitumor properties. In this proprietary
process biopsies and live cancer cells lines are treated, In vitro, with innumerous combinations of cannabinoids and the resulting
antitumor effects are screened, categorized and actually visually displayed.
Competitive Factors
The Pharmaceutical industry is highly competitive
and we will be competing with many other and better financed companies.
We are an early stage pharmaceutical company,
with deminimis positive 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.
Regulations
Cannabics 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 are duly licensed by the Israeli Health Ministry for our research in Israel. Beyond the Israeli
Health Ministry (by whom we are licensed), 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.
It is imperative for the reader of this report
to recognize that the company itself does not manufacture, distribute, or dispense any controlled substances, including cannabis,
rather it develops proprietary technologies that are then licensed for use by certified and governmentally approved manufacturers.
However, as is well known, US Federal regulations continue to consider Cannabis a schedule 1 drug, meaning that it has no currently
accepted medical use in treatment, and thus illegal under Federal US laws. As such, the company could be deemed to be at variance
with the Federal Controlled Substances Act.
Employees
As of August 31, 2016, the Company had 2 employees,
one of which was our Director Eyal Ballan, who, along with our administrative assistant were given monthly salaries. We do not
presently have pension, health, annuity, insurance, stock options, profit sharing or similar benefit plans; however, we may adopt
such plans in the future.
Item 1A. Risk Factors
We are a smaller reporting company as defined
by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
Risk Factors
You should consider carefully the risks and uncertainties
described below, together with all of the other information in this Annual Report on Form 10-K. If any of the following risks
are realized, our business, financial condition, results of operations and prospects could be materially and adversely affected.
The risks described below are not the only risks facing the Company. Risks and uncertainties not currently known to us or that
we currently deem to be immaterial also may materially adversely affect our business, financial condition, results of operations
and prospects.
Risks Related to Our Company and Business
Our independent auditors have expressed substantial doubt
about our ability to continue operating as a going concern, which could prevent us from obtaining new financing on reasonable
terms or at all.
Our independent registered public accountants have expressed
substantial doubt about our ability to continue as a going concern. This opinion could materially limit our ability to raise additional
funds by issuing new debt or equity securities or otherwise. If we fail to raise sufficient capital when needed, we will not be
able to complete our proposed business. As a result we may have to liquidate our business and investors may lose their investments.
Our ability to continue as a going concern is dependent upon our ability to successfully accomplish our plan of operations described
in this prospectus, obtain financing and eventually attain profitable operations. Investors should consider our independent registered
public accountant’s comments when deciding whether to invest in the Company.
We have not generated any significant revenue since our
inception and we may never achieve profitability.
We are an early stage biotechnology company and have not generated
any significant revenue since we commenced our present operations in April 2014. At the present time, Cannabics SR is the only
product that we have commercialized. To date, we have financed our operations primarily through private placements of common stock,
warrants, and direct equity investments. As we continue our research and development of cannabinoid-based diagnostics, our expenses
are expected to increase significantly. Accordingly, we will need to generate significant revenue to achieve profitability. Even
as we begin to commercialize our technologies, we expect our losses to continue as a result of ongoing research and development
expenses. These losses, among other things, have had and will continue to have an adverse effect on our working capital, total
assets and stockholders’ equity. Because of the numerous risks and uncertainties associated with product development and
commercialization efforts, we are unable to predict at what stage the Company will become profitable. We may never become profitable.
Even if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. If
we are unable to achieve and then maintain profitability, our business, financial condition and results of operations will be
negatively affected and the market value of our common stock will decline.
Since we have a limited operating history in our business,
it is difficult for potential investors to evaluate our business.
We commenced operations as a biotechnology
company in April 2014, and therefore have a relatively short operating history upon which an evaluation of our future success
or failure can objectively be made. Our business is a highly speculative undertaking and involves a substantial degree of risk.
We have not demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by early-stage
companies in new and rapidly evolving competitive fields, including under-capitalization, cash shortages, limitations with respect
to personnel, financial, and other resources and lack of revenue. The likelihood of our success must be considered in light of
the early stage of our operations. There is no assurance that our business will ever be successful or that we will be able to
attain profitability. Any failure by the Company to report profits may adversely affect the price of our common stock.
We will need to raise additional capital to meet our business
requirements in the future, which may be costly or difficult to obtain and could dilute our stockholders’ ownership interests.
The Company has not yet
generated meaningful revenue and will require additional capital to continue its research and development activities, conduct
clinical trials, commercialize its products and otherwise fund its operations. Our ability to secure required financing will
depend in part upon investor perception of our ability to create a successful business. Capital market conditions and other
factors beyond our control may also play important roles in our ability to raise capital. There can be no assurance that debt
or equity financing will be available or sufficient for our requirements or for other corporate purposes, or if debt or
equity financing is available, that it will be on terms acceptable to us. Moreover, future activities may require us to alter
our capitalization significantly. Our inability to access sufficient capital for our operations could have a material
adverse effect on our financial condition, results of operations and prospects. If we are unable to obtain additional funding
as needed, we may be required to reduce the scope of our research and development activities, which could harm our
business plan, financial condition and operating results, or we may be required to cease our operations entirely, in which
case, our investors will lose all of their investment.
Any additional capital raised through the sale of equity or
equity-backed securities may dilute our stockholders’ ownership percentages and could also result in a decrease in the market
value of our equity securities. The terms of any securities issued by us in future capital transactions may be more favorable
to new investors, and may include preferences, superior voting rights and the issuance of warrants or other derivative securities,
which may have a further dilutive effect on the holders of our securities then outstanding. Any debt financing secured in the
future could involve restrictive covenants relating to capital raising activities and other financial and operational matters,
which may make it more difficult for us to obtain additional capital and to pursue business opportunities.
In addition, we may incur substantial costs
in pursuing future capital financing, including investment banking fees, legal fees, accounting fees, securities law compliance
fees, printing and distribution expenses and other costs. We may also be required to recognize non-cash expenses in connection
with certain securities we issue, such as convertible notes and warrants, which may have an adverse impact on our financial condition.
We are highly dependent on the success of cannabinoid technology,
and we may not be able to develop the technology, successfully obtain regulatory or marketing approval for, or successfully commercialize,
our products or product candidates.
Our business is focused entirely upon the research, development
and commercialization of cannabinoid-based technologies for the detection and treatment of cancer. Our success is dependent upon
the viability of this technology and the development of cancer diagnostics and therapies.
Neither we nor any other company has received regulatory approval
from the United States Food and Drug Administration (the “FDA”) to market any diagnostics or therapeutics based on
botanical cannabinoids, though the FDA has approved two drugs that contain a synthetic substance that acts similarly to cannabis
compounds but is not present in the cannabis plant.
The scientific evidence underlying the feasibility of developing
cannabinoid-based technologies for the detection and treatment of cancer is both preliminary and limited. In 2017, an
ad hoc
committee of the National Academies of Sciences, Engineering, and Medicine determined that while there is conclusive or substantial
evidence that oral cannabinoids are effective antiemetics in the treatment of chemotherapy-induced nausea and vomiting, there
was insufficient evidence to make any statement about the efficacy of cannabinoids as a treatment for cancer. The
ad hoc
committee went on to state that further clinical research into the anti-cancer effects of cannabinoids needs to be conducted.
If our cannabinoid technology is found to be ineffective or
unsafe in humans, or if it never receives regulatory approval for commercialization, we may never be able bring our product candidates
to market and may never become profitable. Further, our current business strategy, including all of our research and development,
is focused on utilizing cannabinoid technology to detect and treat cancer. This lack of diversification increases the risk associated
with the ownership of our common stock. If we are unsuccessful in developing and commercializing our cannabinoid-based technology
and its application to the detection and treatment of cancer, we may be required to alter our scope and direction and steer away
from the intellectual property we have developed as well as the core capabilities of our management team and advisory board. Without
successful commercialization of our products and product candidates, we may never become profitable, which would have a material
adverse effect on our business, results of operations and financial condition.
Our success depends upon our ability to retain our senior
management and our ability to attract, retain and motivate other qualified personnel.
We are an early stage biotechnology company. As of
February 28, 2017, we had two employees and several key consultants. Our success materially depends upon the efforts of our
management and other key personnel, including but not limited to Dr. Eyal Ballan, our Chief Technology Officer and a
Director. If we lose the services of Dr. Ballan or any other executive officers or significant employees, our business would
likely be materially and adversely affected. At this time, we do not currently have “key man” life insurance for
Dr. Ballan or any other executive officer.
Because of the specialized scientific and managerial nature
of our business, we rely heavily on our ability to attract and retain qualified scientific, technical and managerial personnel.
The competition for qualified personnel in the biotechnology industry is intense. Due to this intense competition, we may be unable
to continue to attract and retain qualified personnel necessary for the development of our business or to recruit suitable replacement
personnel. Any difficulties in obtaining and retaining qualified officers, employees and consultants could have a material adverse
effect on our operations.
The relative lack of public company experience by our management
team may put us at a competitive disadvantage.
As a company with a class of securities registered under the
United States Securities Exchange Act of 1934, as amended (the “Exchange Act”), we are subject to reporting and other
legal, accounting, corporate governance, and regulatory requirements imposed by the Exchange Act and rules and regulations promulgated
under the Exchange Act. With the exception of our CFO, Uri Ben-Or, our management team lacks significant public company experience,
which could impair our ability to comply with these legal, accounting, and regulatory requirements. Such responsibilities include
complying with federal securities laws and making required disclosures on a timely basis. Our senior management may not be able
to implement and effect programs and policies in an effective and timely manner that adequately respond to such increased legal
and regulatory compliance and reporting requirements. Our failure to do so could lead to the imposition of fines and penalties
and further result in the deterioration of our business.
If we are unable to enter into acceptable sales, marketing
and distribution arrangements with third parties or establish sales, marketing and distribution capabilities, we may not be successful
in commercializing any product candidate that we develop if and when a product candidate is approved.
We do not have any sales, marketing or distribution infrastructure
and have no experience in the commercialization of biotechnology. To achieve commercial success for any product, we must develop
a sales and marketing organization, outsource these functions to third parties or license our products to others.
In the United States, we intend to only commercialize our products
by licensing them to organizations having greater resources and experience than we do. While we have already licensed our Cannabics
SR medical cannabis capsules in Colorado to Mountain High Products LLC, and in states outside of Colorado to the Cima Group LLC,
there can be no assurance that such licensing efforts will be successful, or that we will be able to license any future products
on satisfactory terms, or at all. We do not presently have any other agreement or arrangement for the commercialization of our
products in the United States or elsewhere.
While we generally intend to adopt a licensing model for
the commercialization of our products, we may also seek one or more strategic partners for commercialization of our products
outside the United States. As a result of entering into arrangements with third parties to perform sales, marketing and
distribution services, our product revenue or the profitability of our product revenue may be lower, perhaps substantially
lower, than if we were to directly market and sell products in those markets. Furthermore, we may be unsuccessful in entering
into the necessary arrangements with third parties or may be unable to do so on terms that are favorable to us. In addition,
we may have little or no control over such third parties and any of them may fail to devote the necessary resources and
attention to sell and market our product candidates effectively.
If we do not license our products or outsource our commercialization
efforts, we will be required to develop our own sales, marketing and distribution capabilities, which will require substantial
resources and will be time-consuming, and could delay any product launch. Moreover, we may not be able to hire or retain a sales
force that is sufficient in size or has adequate expertise in the consumer health markets that we plan to target. If we are unable
to establish or retain a sales force and marketing and distribution capabilities, our operating results may be adversely affected.
If we do not successfully license our products or establish
sales and marketing capabilities, either on our own or in collaboration with third parties, it is likely that we will be unable
to commercialize any of our products.
We face intense competition, often from companies with
greater resources and experience than we have, which may result in others developing or commercializing competing products before
us or more successfully.
The market for cancer diagnostics and therapies is intensely
competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry
participants. Our competitors include large multinational corporations and their operating units, including Abbott Laboratories
Inc., Cepheid Inc., Philips, GE Healthcare, Siemens, Gen-Probe Incorporated, MDxHealth SA, EpiGenomics AG, Roche Diagnostics,
Exact Sciences Corporation, Sequenom, Inc. and several others. We also compete against pharmaceutical companies, specialty pharmaceutical
companies and biotechnology companies worldwide, as well as smaller and other early-stage companies. Other potential competitors
include academic institutions, government agencies and other public and private research organizations that conduct research,
seek patent protection and establish collaborative arrangements for research, development, manufacturing and commercialization.
Many of our competitors and potential competitors have or will
have substantially greater financial, technological, managerial and research and development resources and experience than we
have, and many have been engaged in the biotechnology industry for a much longer time than we have. Many of our competitors spend
significantly more funds on research, development, promotion and sale of new and existing products than we do, and may therefore
be able to react more quickly to new or emerging technologies, shifting market conditions and regulatory changes.
There can be no assurance that any of our current or future
products and technologies will have a competitive advantage in the marketplace, or that they will remain competitive following
the introduction of competing products or technologies. Our commercial opportunity could be reduced or eliminated if our competitors
develop and commercialize products that are safer, more effective, more convenient or less expensive. There can be no assurance
that we will be successful in the face of increasing competition from new technologies or products introduced by existing companies
in the industry or by new companies entering the market.
If we are unable to compete successfully, there may be a material
and adverse effect on our business, financial condition and results of operations.
If the marketplace does not accept the products in our
development pipeline or any other diagnostic products we might develop, we may be unable to generate sufficient revenue to sustain
and grow our business.
Even if we are able to successfully develop and obtain regulatory
approval of a product candidate, our ability to generate significant revenue will depend on the acceptance of our products by
physicians and patients. Physicians, hospitals, clinical laboratories, researchers or others in the healthcare industry may not
use our current or future diagnostic product candidates unless they are determined to be an effective and cost-efficient means
of detecting and diagnosing cancer. Market acceptance of our current or future therapeutic products will depend on a number of
factors, including the indication statement and warnings approved by regulatory authorities in the product label, continued demonstration
of efficacy and safety in commercial use, physicians’ willingness to prescribe the product, reimbursement from third-party
payers such as government healthcare systems and insurance companies, the price of the product, the nature of any post-approval
risk management plans mandated by regulatory authorities, competition, marketing and distribution support. In addition, we will
need to expend a significant amount of resources on marketing and educational efforts to create awareness of our products and
to encourage their acceptance and adoption. If the market for our products does not develop sufficiently or the products are not
accepted, our revenue potential will be harmed.
We do not presently have any product liability insurance
coverage and there is no assurance that we will be able to obtain such insurance at an affordable price or that it will be sufficient
to cover all liabilities that we may incur.
We are exposed to potential product
liability risks that are inherent in the testing, manufacturing and marketing of cancer diagnostics, pharmaceuticals and dietary
supplements. While we do not presently carry any product liability insurance coverage, we intend to obtain such insurance in amounts
we believe to be commercially reasonable for our current level of activity and exposure. There is no assurance, however, that
we will be able to obtain or maintain insurance coverage that will be adequate to cover our potential liabilities, or that premiums
will be commercially justifiable. Furthermore, insurance that might otherwise be readily available, may be more difficult for
us to find and more expensive because we work with medicinal cannabis. If we are the subject of a successful product liability
claim that exceeds the limits of, or is not otherwise covered by our insurance, or if we incur such liability at a time when we
are not able to obtain liability insurance, we may incur substantial charges that adversely affect our earnings and require the
commitment of capital resources that might otherwise be available for the development and commercial launch of our product programs.
If we fail to protect our intellectual property rights,
our ability to pursue the development of our technologies and products would be negatively affected.
Our success will depend in part on our ability to protect our
intellectual property. This is done, in part, by obtaining patents and trademarks and then maintaining adequate protection of
our technologies, tradenames and products. If we do not adequately protect our intellectual property, competitors may be able
to use our technologies to produce and market products in direct competition with us and erode our competitive advantage. Some
foreign countries lack rules and methods for defending intellectual property rights and do not protect proprietary rights to the
same extent as the United States. Many companies have had difficulty protecting their proprietary rights in these foreign countries.
We may not be able to prevent misappropriation of our proprietary rights.
We are currently seeking patent protection for several processes
and finished products. However, the patent process is subject to numerous risks and uncertainties, and there can be no assurance
that we will be successful in protecting our products by obtaining and defending patents. These risks and uncertainties include
the following:
|
–
|
patents
that may be issued or licensed may be challenged, invalidated, or circumvented, or otherwise
may not provide any competitive advantage;
|
|
–
|
our
competitors, many of which have substantially greater resources than us and many of which
have made significant investments in competing technologies, may seek, or may already
have obtained, patents that will limit, interfere with, or eliminate our ability to make,
use, and sell our products and product candidates either in the United States or in international
markets;
|
|
–
|
there
may be significant pressure on the United States government and other international governmental
bodies to limit the scope of patent protection both inside and outside the United States
for treatments that prove successful as a matter of public policy regarding worldwide
health concerns;
|
|
–
|
countries
other than the United States may have less restrictive patent laws than those upheld
by United States courts, allowing foreign competitors the ability to exploit these laws
to create, develop, and market competing products.
|
Any patents issued to us may not provide us with meaningful
protection, and third parties may challenge, circumvent or narrow them. Third parties may also independently develop products
similar to our products or product candidates, duplicate our unpatented product or product candidates, and design around any patents
on product candidates we may develop.
Additionally, extensive time is required for development, testing
and regulatory review of product candidates. While extension of a patent term due to regulatory delays may be available, it is
possible that before any of our product candidates can be commercialized, any related patent, even with an extension, may expire
or remain in force for only a short period following commercialization, thereby reducing any advantages of the patent.
In addition, the United States Patent and Trademark Office (the
“USPTO”), and patent offices in other jurisdictions have often required that patent applications concerning biotechnology-related
inventions be limited or narrowed substantially to cover only the specific innovations exemplified in the patent application,
thereby limiting the scope of protection against competitive challenges. Thus, even if we or our licensors are able to obtain
patents, the patents may be substantially narrower than anticipated.
In addition to patents, we rely on a combination of trade secrets,
confidentiality, nondisclosure and other contractual provisions, and security measures to protect our confidential and proprietary
information. These measures may not adequately protect our trade secrets or other proprietary information. If they do not adequately
protect our rights, third parties could use our technology, and we could lose any competitive advantage we may have. In addition,
others may independently develop similar proprietary information or techniques or otherwise gain access to our trade secrets,
which could impair any competitive advantage we may have.
Costly litigation may be necessary to protect our intellectual
property rights and we may be subject to claims alleging the violation of the intellectual property rights of others.
We may face significant expense and liability as a result of
litigation or other proceedings relating to patents and other intellectual property rights of others. If another party has also
filed a patent application or been issued a patent relating to an invention or technology claimed by us in pending applications,
we may be required to participate in an interference proceeding declared by the USPTO to determine priority of invention, which
could result in substantial uncertainties and costs, even if the eventual outcome were favorable to us. We could also be required
to participate in interference proceedings involving issued patents and pending applications of another entity. An adverse outcome
in an interference proceeding could require us to cease using the technology or to license rights from prevailing third parties.
The cost to us of any patent litigation or other proceeding
relating to our patents or patent applications, even if resolved in our favor, could be substantial. Our ability to enforce our
patent protection could be limited by our financial resources, and may be subject to lengthy delays.
A third party might claim that we are using inventions claimed
by their patents and might go to court to stop us from engaging in our normal operations and activities, such as research, development
and the sale of any future products. Such lawsuits are expensive and would consume time and other resources. There is a risk that
the court will decide that we are infringing the third party’s patents and will order us to stop the activities claimed
by the patents, redesign our products or processes to avoid infringement or obtain licenses (which may not be available on commercially
reasonable terms). In addition, there is a risk that a court will order us to pay the other party damages for having infringed
their patents.
There is no guarantee that any prevailing patent owner would
offer us a license so that we could continue to engage in activities claimed by the patent, or that such a license, if made available
to us, could be acquired on commercially acceptable terms. In addition, third parties may, in the future, assert other intellectual
property infringement claims against us with respect to our products, technologies or other matters.
Failure in our information technology or storage systems
could significantly disrupt our operations and our research and development efforts, which could adversely impact our revenues,
as well as our research, development and commercialization efforts.
Our ability to execute our business strategy depends, in part,
on the continued and uninterrupted performance of our information technology (“IT”), systems, which support our operations
and our research and development efforts, as well as our storage systems. Due to the sophisticated nature of the technology we
use in our products and service offerings, we are substantially dependent on our IT systems. IT systems are vulnerable to damage
from a variety of sources, including telecommunications or network failures, malicious human acts and natural disasters. Moreover,
despite network security and back-up measures, some of our servers are potentially vulnerable to physical or electronic break-ins,
computer viruses and similar disruptive problems. Despite the precautionary measures we have taken to prevent unanticipated problems
that could affect our IT systems, sustained or repeated system failures that interrupt our ability to generate and maintain data,
could adversely affect our ability to operate our business.
We will need to grow the size of our organization, and
we may experience difficulties in managing any growth we may achieve.
As of the date of this prospectus, we have two full-time employees.
As our development and commercialization plans and strategies progress, we expect to need additional research, development, managerial,
operational, sales, marketing, financial, accounting, legal and other resources. Future growth would impose significant added
responsibilities on our management, which may not be able to accommodate those added responsibilities. If we fail to effectively
manage our future growth, it could delay the execution of our business plan and disrupt our operations.
We are subject to financial reporting and other requirements
that place significant demands on our resources.
We are subject to reporting and other obligations under the
Securities Exchange Act of 1934, as amended, including the requirements of Section 404 of the Sarbanes-Oxley Act of 2002. Section
404 requires us to conduct an annual management assessment of the effectiveness of our internal controls over financial reporting.
These reporting and other obligations place significant demands on our management, administrative, operational, internal audit
and accounting resources. The costs of preparing and filing annual and quarterly reports, proxy statements and other information
with the SEC and furnishing audit reports to stockholders causes our expenses to be higher than they would be if we remained a
privately-held company. The increased costs associated with operating as a public company may decrease our net income or increase
our net loss, and may cause us to reduce costs in other areas of our business or increase the prices of our product to offset
the effect of such increased costs. Additionally, if these requirements divert our management’s attention from other business
concerns, they could have a material adverse effect on our business, financial condition and results of operations.
Our disclosure controls and procedures and internal controls
over financial reporting were determined not to be effective for the prior fiscal year ended August 31, 2016, and may not be effective
in future periods.
Effective internal controls are necessary for us to provide
reasonable assurance with respect to our financial reports and to effectively prevent fraud. If we cannot provide reasonable assurance
with respect to our financial reports and effectively prevent fraud, our reputation and operating results could be harmed. Pursuant
to the Sarbanes-Oxley Act of 2002, we are required to furnish a report by management on internal control over financial reporting,
including management’s assessment of the effectiveness of such control. Internal control over financial reporting may not
prevent or detect misstatements because of its inherent limitations, including the possibility of human error, the circumvention
or overriding of controls, or fraud. Therefore, even effective internal controls can provide only reasonable assurance with respect
to the preparation and fair presentation of financial statements. In addition, projections of any evaluation of effectiveness
of internal control over financial reporting to future periods are subject to the risk that the control may become inadequate
because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. If we fail
to maintain the adequacy of our internal controls, including any failure to implement required new or improved controls, or if
we experience difficulties in their implementation, our business and operating results could be adversely impacted, we could fail
to meet our reporting obligations, and our business and stock price could be adversely affected.
At August 31, 2016, our Chief Executive Officer and Chief Financial
Officer evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules
13a-15(e) and 15d-15(e) under the Exchange Act) and concluded that, subject to the inherent limitations identified in Item 9A
of Part II of our Annual Report on Form 10-K for the fiscal year ended August 31, 2016, our disclosure controls and procedures
were not effective due to the existence of material weaknesses in our internal control over financial reporting arising from inadequate
segregation of duties over authorization, review and recording of transactions, as well as the financial reporting of such transactions,
the lack of an audit committee, insufficient documentation of review procedures and insufficient information technology procedures.
Our independent auditors issued an adverse attestation report regarding the effectiveness of our internal control over financial
reporting as at August 31, 2016.
We believe we have taken appropriate and reasonable steps to
make the necessary improvements to remediate these deficiencies, however we cannot be certain that our remediation efforts will
ensure that our management designs, implements and maintains adequate controls over our financial processes and reporting in the
future or that the changes made will be sufficient to address and eliminate the material weaknesses previously identified. Our
inability to remedy any additional deficiencies or material weaknesses that may be identified in the future could, among other
things, have a material adverse effect on our business, results of operations and financial condition, as well as impair our ability
to meet our quarterly, annual and other reporting requirements under the Exchange Act in a timely manner, and require us to incur
additional costs or to divert management resources.
Risks Related to Cannabis
Our failure to comply with controlled substance legislation
could restrict or harm our ability to develop and commercialize our products.
Our business is, and will be, subject to wide-ranging laws and
regulations of Israel, the United States (federal and state), the European Community and other governments in each of the countries
where we may develop and market our products. We must comply with all regulatory requirements if we expect to be successful.
Most countries are parties to the Single Convention on Narcotic
Drugs of 1961 as amended by the 1972 Protocol, which governs international trade and domestic control of narcotic substances,
including cannabis extracts. Countries may interpret and implement their treaty obligations in a way that creates a legal obstacle
to us obtaining marketing approval in those countries for any cannabinoid-based products we develop. These countries may not be
willing or able to amend or otherwise modify their laws and regulations to permit our products to be marketed, or achieving such
amendments to the laws and regulations may take a prolonged period of time. In the case of countries with similar obstacles, we
would be unable to market our product candidates in countries in the near future or perhaps at all if the laws and regulations
in those countries do not change.
Any cannabinoid-based product candidate that we may develop
for use in the United States, will be subject to U.S. controlled substance laws and regulations that will require us, along with
our collaborators and licensees, to expend time, money and effort in all areas of regulatory compliance, including, if applicable,
manufacturing, production, quality control and assurance and clinical trials. Any failure to comply with these laws and regulations,
or the cost of compliance with these laws and regulations, could adversely affect the results of our business operations and our
financial condition.
The constant evolution of laws and regulations affecting the
research and development of cannabis-based diagnostics and therapies could detrimentally affect our business. Laws and
regulations related to the therapeutic uses of cannabis are subject to changing interpretations. These changes may require us
to incur substantial costs associated with legal and compliance fees and ultimately require us to alter our business plan. Furthermore,
violations or alleged violation of these laws could disrupt our business and result in a material adverse effect on our operations,
including our ability to conduct clinical trials that are prerequisite to our ability to commercialize our cannabis-based medical
products and therapies. We cannot predict the nature of any future laws, regulations, interpretations or applications of laws
and regulations and it is possible that new laws and regulations may be enacted in the future that will be directly applicable
to our business.
Cannabis remains illegal under U.S. federal law, and any
change in the enforcement priorities of the federal government could render our current and planned future operations unprofitable
or even prohibit such operations.
We are a biotechnology company focused on the research and
development of cannabinoid-based diagnostics, anti-cancer pharmaceuticals and palliative therapies. The commercial viability of
our products and technologies in the United States depends, in part, on state laws and regulations; however, Cannabis remains
illegal under federal law.
The United States federal government regulates drugs through
the Controlled Substances Act, which places controlled substances, including cannabis, on one of five schedules. Cannabis is currently
classified as a Schedule I controlled substance, which is viewed as having a high potential for abuse and no currently accepted
medical use in treatment in the United States. No prescriptions may be written for Schedule I substances, and such substances
are subject to production quotas imposed by the United States Drug Enforcement Administration. Because of this, doctors may not
prescribe cannabis for medical use under federal law, although they can recommend its use under the First Amendment.
Currently, twenty-eight U.S. states and the District of Columbia
allow the use of medical cannabis. Eight states and the District of Columbia also allow its recreational use. Because cannabis
is a Schedule I controlled substance, however, the development of a legal cannabis industry under the laws of these states is
in conflict with the Federal Controlled Substances Act, which makes cannabis use and possession illegal on a national level. The
United States Supreme Court has confirmed that the federal government has the right to regulate and criminalize cannabis, including
for medical purposes, and that federal law criminalizing the use of cannabis pre-empts state laws that legalize its use.
In 2014, the United States House of Representatives passed an
amendment (the “Rohrabacher-Farr Amendment”) to the Commerce, Justice, Science, and Related Agencies Appropriations
Bill, which funds the United States Department of Justice (the “DOJ”). The Rohrabacher-Farr Amendment prohibits the
DOJ from using funds to prevent states with medical cannabis laws from implementing such laws. In August 2016, a Ninth Circuit
federal appeals court ruled in
United States v. McIntosh
that the Rohrabacher-Farr Amendment bars the DOJ from spending
funds on the prosecution of conduct that is allowed by state medical cannabis laws, provided that such conduct is in strict compliance
with applicable state law. In March 2015, bipartisan legislation titled the Compassionate Access, Research Expansion, and Respect
States Act (the “CARERS Act”) was introduced, proposing to allow states to regulate the medical use of cannabis by
changing applicable federal law, including by reclassifying cannabis under the Controlled Substances Act to a Schedule II controlled
substance and thereby changing the plant from a federally-criminalized substance to one that has recognized medical uses.
Although these developments have been met with a certain amount
of optimism in the scientific community, the CARERS Act has not yet been adopted, and the Rohrabacher-Farr Amendment, being an
amendment to an appropriations bill, must be renewed annually. The currently enacted Commerce, Justice, Science, and Related Agencies
Act, which includes the Rohrabacher-Farr Amendment, is effective, by passage of a short-term continuing resolution, through April
28, 2017. The federal government could at any time change its enforcement priorities against the cannabis industry. We do not
grow or distribute cannabis, but our current and planned business operations involve licensing cannabinoid-based products and
technology. Any change in enforcement priorities could render such operations unprofitable or even prohibit such operations.
Our ability to earn revenue through licensing our product
in the United States is dependent on additional states legalizing medical marijuana.
We are engaged in the business developing and commercializing
cannabinoid-based products for the detection and treatment of cancer. Our ability to commercialize our products in the United
States is dependent upon the continued progress of legislative authorization of cannabis at the state level for medical purposes
and, in certain states, based on the specifics of the legislation passed in that state. Any number of factors could slow or halt
the progress. Furthermore, progress, while encouraging, is not assured. The legislative process normally encounters set-backs
before achieving success. While there may be ample public support for legislative proposals, there must be political will in the
legislative committee or a bill may never advance to a vote. Numerous factors impact the legislative process. Any one of these
factors could slow or halt the progress and adoption of cannabis for medical purposes, which would limit the market for our products
and negatively impact our business and revenues.
Changes in consumer preferences and acceptance of medical
cannabis, or any negative trends, will adversely affect our business.
Our business is substantially dependent on market acceptance
of medical cannabis. Market perception of medical cannabis can be significantly influenced by a number of social, political and
economic factors that are beyond our control, including scientific research or findings, regulatory investigations, litigation,
media attention and other publicity regarding such products and treatments. There can be no assurance that future scientific research,
findings, regulatory proceedings, litigation, media attention or other research findings or publicity will be favorable to the
market for any of our current or future cannabinoid-based diagnostics or therapies. Future research reports, findings, regulatory
proceedings, litigation, media attention or other publicity that are perceived as less favorable than, or that question, earlier
research reports, findings or publicity could have a material adverse effect on the demand for our products, as well as our business,
results of operations, financial condition and cash flows.
We believe that as cannabis-based biotechnology becomes more
widely accepted by the U.S. medical community and the public at large, the stigma associated with medical cannabis will moderate
and, as a result, consumer demand will likely continue to grow. There is, however, no assurance that such increase in demand will
occur, that we will benefit from any demand increase or that our business will ever become profitable. We cannot predict the future
growth rate and size of the market, assuming that the regulatory climate permits, of which there can be no assurance. Any negative
outlook on medical cannabis will adversely affect our business prospects.
We also believe that large, well-funded pharmaceutical and other
related businesses and industries may have economic reasons to oppose cannabinoid-based therapies. The pharmaceutical industry
is well-funded with a strong and experienced lobby presence at both the federal and state levels, as well as internationally,
that surpasses financial resources of the current group of medical cannabis research and development companies. Any effort by
the pharmaceutical lobby to halt or delay cannabinoid-based medical products and therapies could have a detrimental impact on
our business.
Risks Related to Product Development
If we fail to successfully develop and commercialize diagnostics,
pharmaceutical or therapies, we may be unable to execute our plan of operations.
Our current business strategy focuses on discovering, developing
and commercializing cannabinoid-based diagnostics, anti-cancer pharmaceuticals and palliative therapies. To date, we have only
commercialized Cannabics SR, our non-pharmaceutical extended release capsules for palliative therapy. The success of our business
will depend upon our ability to fully develop and commercialize the diagnostics and therapeutic product candidates in our current
development pipeline as well as to continue the discovery and development of other products and technology.
Prior to commercializing our product candidates, we will be
required to undertake time-consuming and costly development activities with uncertain outcomes, including conducting clinical
studies and obtaining regulatory clearance or approval in Israel, the United States, the European Union and other countries where
we may develop and market our product candidates. Delays in obtaining approvals and clearances could have material adverse effects
on us and our ability to fully carry out our plan of operations. We have limited experience in taking products through these processes
and there are considerable risks involved in these activities. The science and methods that we are employing are innovative and
complex, and it is possible that our development programs will ultimately not yield products suitable for commercialization or
government approval. Product candidates that appear promising in early development may fail to be validated in subsequent studies,
and even if we achieve positive results, we may still fail to obtain the necessary regulatory clearances or approvals. Few research
and development projects result in commercial products, and perceived viability in early clinical studies often is not replicated
in later studies. At any point, we may abandon development of a product candidate, or we may be required to expend considerable
resources obtaining additional clinical and nonclinical data, which would adversely impact the timing for generating potential
revenue from those products. Further, our ability to develop and launch product candidates is dependent on our receipt of substantial
additional funding. If our discovery and development programs yield fewer commercial product candidates than we expect, we may
be unable to execute our business plan, and our business, financial condition and results of operations may be adversely affected.
If we fail to maintain or establish satisfactory arrangements
for the supply of raw materials or the manufacture of our product candidates for preclinical or clinical trials, or if we experience
an interruption of supply, we might not have sufficient quantities of our product candidates at an acceptable cost, which could
delay, prevent or impair our development or commercialization efforts
We do not produce medical cannabis, and therefore our ability
to research, develop and commercialize our cannabinoid-based diagnostics and therapeutic product candidates is dependent upon
a sufficient supply of medical cannabis strains. Any significant interruption or negative change in the availability or economics
of the supply chain for medical cannabis could materially impact our business, financial condition and operating results. Some
strains of medical cannabis may only be available from a single supplier or a limited group of suppliers. If a sole source supplier
were to go out of business, we might be unable to find a replacement source in a timely manner or at all. If a sole source supplier
were to be acquired by a competitor, that competitor might elect not to supply us. Any inability to secure required supplies of
medical cannabis or to do so on appropriate terms could have a materially adverse impact on our business, financial condition
and operating results.
Our clinical diagnostics may never be validated.
The FDA regulates the sale and distribution, in interstate commerce,
of
in vitro
diagnostic test kits, reagents and instruments used to perform diagnostic testing. To the extent that any diagnostic
test we develop is regarded as an
in vitro
diagnostic test rather than as a Laboratory Developed Test (“LDT”),
we will be subject to increased FDA regulation that will delay and add to the cost of commercialization of our diagnostic product
candidates, which will have a material adverse effect on our business, results of operations and financial condition.
We are also subject to the United States Clinical Laboratory
Improvement Amendments of 1988 (“CLIA”), federal regulatory standards that apply to all clinical laboratories that
perform testing on specimens derived from humans in the United States for the purpose of providing information for the diagnosis,
prevention or treatment of disease. CLIA is intended to ensure the quality and reliability of clinical laboratories in the United
States by mandating specific standards in the areas of personnel qualifications, administration, and participation in proficiency
testing, patient test management, quality control, quality assurance and inspections. Accreditation by the College of American
Pathologists (“CAP”), one of six CLIA-approved accreditation organizations, is sufficient to satisfy the requirements
of CLIA.
The validation for CLIA or CAP is a two-step process. The first
step is optimization of all of the steps of the test protocol to show that the test is able to produce repeatable and consistent
results. The second step is the clinical validation, in which statistically significant sensitivity and specificity of the test
on the appropriate human samples are determined. Overall, the purpose of the validation process is to determine the accuracy,
precision, sensitivity and specificity of the test. The time and cost to complete the validation process can vary widely, and
it is possible that we would be unable to complete the validation process along the timeline and within the budget as planned.
As of the date of this prospectus, our clinical diagnostics
have not yet been validated for commercialization in a CLIA or CAP laboratory, and we have not yet begun the validation process.
We may be unable to enter into an agreement with a CLIA or CAP laboratory on favorable terms, or at all. Although we may be able
to validate the tests, they might have sensitivity and specificity that is insufficient to bring the product to market. Any delays
or incurrence of greater costs than budgeted in validating these tests may have a material adverse effect on our business, results
of operations and financial condition.
The Federal Food and Drug Administration may impose additional
regulatory obligations and costs upon the development of our diagnostics.
On October 3, 2014, the FDA issued draft guidance regarding
oversight of LDTs, titled “Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs).” According to
this guidance, the FDA plans to take a phased-in risk-based approach to regulating LDTs. The FDA plans to phase in enforcement
of LTD premarket review, quality system oversight and adverse event reporting over a number of years. The FDA would require that
laboratories providing LDTs, subject to certain limited exemptions, within six months after the guidance documents are finalized
to comply with (i) either a new notification procedure in which the laboratory must provide the FDA with certain basic information
about each LDT offered by their laboratory or the FDA’s device registration and listing requirements, and (ii) the medical
device reporting, or MDR, requirements for LDTs offered by that laboratory. Under this new risk-based approach, it is possible
that some level of pre-market review may be required for our LDTs, which may require us to obtain additional clinical data.
The FDA draft guidance was subject to public comment until February
2, 2015. On January 13, 2017, the FDA issued a discussion paper on LDTs that does not represent the formal position of FDA and
is not enforceable, but is intended to advance public discussion on future LDT oversight. At the present time, we cannot assess
what the additional costs and regulatory burdens of any FDA final guidance or FDA enforcement will be, or the impact it may have
on our business and operations.
If the FDA requires us to seek clearance or approval for any
of our diagnostic products (as opposed to simply licensing our technology to a CLIA lab), we may not be able to obtain such approvals
on a timely basis, or at all. The cost of conducting clinical trials and otherwise developing data and information to support
any applications may be significant. Failure to comply with applicable regulatory requirements of the FDA could result in enforcement
action, including receiving untitled or warning letters, fines, injunctions, or civil or criminal penalties. In addition, we could
be subject to a recall or seizure of products, operating restrictions, partial suspension or total shutdown of production. Any
such enforcement action would have a material adverse effect on our business, financial condition and operations.
Changes in laws and regulations concerning clinical diagnostic
tests may adversely affect our business, financial condition and results of operations.
The clinical laboratory testing industry is highly regulated,
and failure to comply with applicable regulatory, supervisory or licensing requirements may adversely affect our business, financial
condition and results of operations. In particular, the laws and regulations governing the marketing and research of clinical
diagnostic testing are extremely complex and in many instances there are no clear regulatory or judicial interpretations of these
laws and regulations, which increase the risk that we may be found to be in violation of these laws.
The regulatory environment in which we operate may change significantly
and adversely in the future. The molecular diagnostics industry as a whole is a growing industry and regulatory agencies such
as the FDA may also apply heightened scrutiny to new developments in the field of molecular diagnostics. Should we be deemed to
not be in compliance with regulatory requirements or any changes thereto, we may be subject to sanctions which could include required
changes to our operations, adverse publicity, substantial financial penalties and criminal proceedings. Any change in the laws
and the regulations relating to our business, whether in the form of new or amended laws or regulations or regulatory policies,
or the application of any of the above, may adversely affect our business, financial condition and results of operations by increasing
our costs to comply with the new laws or constraining our ability to develop, market and commercialize our diagnostic tests.
For example, a development affecting our industry is the increased
enforcement of the federal False Claims Act and, in particular, actions brought pursuant to the False Claims Act's "whistleblower"
or "
qui tam
" provisions. The False Claims Act imposes liability on any person or entity that, among other things,
knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal governmental payer program.
The
qui tam
provisions of the False Claims Act allow a private individual to bring civil actions on behalf of the federal
government for violations of the False Claims Act and permit such individuals to share in any amounts paid by the defendant to
the government in fines or settlement. When an entity is determined to have violated the False Claims Act, it is subject to mandatory
damages of three times the actual damages sustained by the government, plus mandatory civil penalties ranging from $5,500 to $11,000
for each false claim. In addition, various states have enacted false claim laws analogous to the federal False Claims Act, and
in some cases go even further because many of these state laws apply where a claim is submitted to any third-party payer and not
merely a governmental payer program.
In addition, there has been a recent trend of increased U.S.
federal and state regulation of payments made to physicians, which are governed by laws and regulations including the Stark Law.
Among other requirements, the Stark Law requires laboratories to track, and places a cap on, non-monetary compensation provided
to referring physicians. While we have a compliance plan to address compliance with applicable fraud and abuse laws and regulations,
the evolving commercial compliance environment and the need to build and maintain robust and expandable systems to comply with
multiple jurisdictions with different compliance and reporting requirements increases the possibility that we could violate one
or more of these requirements.
All of our diagnostics and therapeutic product candidates
are in clinical and preclinical development, the validation of which may not be successful and may be subject to delays, which
would have a material adverse effect on our business, results of operation and financial condition.
To date, we have devoted our resources towards developing the
technology upon which we are building our clinical diagnostics and therapeutic product candidates. Our clinical diagnostic product
candidates have yet to be validated and our clinical therapeutic product candidates are currently in a preclinical development
phase. As of the date of this prospectus, only Cannabics SR, our non-pharmaceutical palliative therapy, has been commercialized.
We may be unable to successfully complete the clinical validation
process for our diagnostic product candidates due to several factors, including our ability to acquire enough samples for full
validation and the procurement of materials necessary to conduct testing.
We may not be able to successfully complete the preclinical
testing necessary to advance our therapeutic product candidates into clinical development, including animal pharmacology and toxicity
studies. The results of any preclinical work may indicate that our therapeutic product candidates do not have the safety or efficacy
necessary to file an Investigational New Drug (“IND”) with the FDA in order to move our product on to the clinical
development process.
Once we initiate the clinical development of our product candidates,
it may be difficult to identify and qualify patients to participate in future clinical trials for our product candidates, and
the timing of our clinical trials depends on the speed at which we can recruit patients to participate in testing as well as completion
of required follow-up periods. If patients are unwilling to participate in our clinical trials due to concerns over the safety
of the product candidate or for other reasons, the timeline for conducting the trials and obtaining regulatory approval may be
delayed. Furthermore, we may also compete for patients with other companies conducting similar clinical trials. Any delays in
our future clinical trials could result in increased costs, delays in product development or termination of the clinical trials
altogether.
Any of these events could have a material adverse effect on
our business, results of operations and financial condition.
We may fail to demonstrate the safety and efficacy of our
therapeutic product candidates in accordance with regulatory standards and may incur delays and substantial costs in our clinical
trials.
In order to commercialize our therapeutic product candidates,
we must conduct extensive clinical trials demonstrating the safety and efficacy of our product candidates in humans. The clinical
testing process is expensive, difficult to design and implement, takes many years to complete and is unpredictable in both its
duration and outcome. A failure of one or more clinical trials can occur at any stage of testing. There is a high failure rate
for drugs and biological products proceeding through clinical trials. The research, testing, manufacturing, labeling, packaging,
storage, approval, sale, marketing, advertising and promotion, pricing, export, import and distribution of drug products are subject
to extensive regulation by the FDA and other regulatory authorities in the United States and other countries, which regulations
differ from country to country. We are not permitted to market our therapeutic product candidates as a prescription pharmaceutical
product in the United States until we receive approval of a New Drug Application (“NDA”), from the FDA, or in any
foreign countries until we receive the requisite approval from such countries. In the United States, the FDA generally requires
the completion of pre-clinical testing and clinical trials of each drug to establish its safety and efficacy and extensive pharmaceutical
development to ensure its quality before an NDA is approved. Regulatory authorities in other jurisdictions impose similar requirements.
Of the large number of drugs in development, only a small percentage result in the submission of an NDA to the FDA and even fewer
are eventually approved for commercialization. We have not submitted an NDA to the FDA or comparable applications to other regulatory
authorities. Preclinical and clinical data is often susceptible to varying interpretations and types of analyses and regulatory
authorities may fail to approve our product. In addition, even if we successfully complete early clinical trials, such results
may not be indicative of the success or results of our later clinical trials.
Our successful completion of clinical trials may be materially
adversely affected by many factors, including:
|
•
|
ineffective trial design and disagreement with the
FDA on final trial design;
|
|
•
|
imposition of a clinical hold following an inspection
of our clinical trial operations by the FDA or other regulatory authorities;
|
|
•
|
difficulties or delays in reaching an agreement with
a contract research organization, and clinical trial sites;
|
|
•
|
delays in obtaining required institutional review board
approval for each trial site;
|
|
•
|
data collected from clinical trials may not be sufficient
to support the submission of a NDA or other submission or to obtain regulatory approval
in the United States or elsewhere;
|
|
•
|
delays or difficulties in recruiting suitable patients
to participate in clinical trials;
|
|
•
|
delays in manufacturing or delivering products and
materials to clinical trial sites;
|
|
•
|
delays or difficulties caused by lack of patient adherence
to treatment or post-treatment follow-up;
|
|
•
|
delays caused by patients dropping out of a trial and
the need for recruiting additional patients; and
|
|
•
|
delays caused by clinical sites dropping out of the
trial and the time required to recruit a new site.
|
Any of the these delays or difficulties could cause us to be
delayed in obtaining marketing approval from regulatory authorities, if at all, or allow us to obtain approval for specific indications
or patient populations that are not as broad as currently targeted. In addition, such delays or difficulties may cause our development
costs or our time to bring our product candidates to market to increase, may weaken our competitive positioning in the market
and may have a material adverse effect on our business, results of operations and financial condition.
We cannot predict if or when we will receive regulatory
approval to commercialize a therapeutic product candidate.
We cannot commercialize a therapeutic product candidate until
the appropriate regulatory authorities, such as the FDA or a state regulating authority, have reviewed and approved the product
candidate. Even if our therapeutic product candidates demonstrate safety and efficacy in clinical trials, regulatory agencies
may not complete their review processes in a timely manner, and we may not be able to obtain timely regulatory approval. We may
never be able to receive regulatory approval for our therapeutic product candidates at all. Additional delays may result if an
FDA advisory committee or other regulatory authority recommends non-approval or restrictions on approval. In addition, we may
experience delays or rejections based upon additional government regulation from future legislation or administrative action,
or changes in regulatory agency policy during the period of product development, clinical trials and the review process. Regulatory
agencies may also approve a product candidate for fewer or more limited indications than requested or may grant approval subject
to the performance of post-marketing studies. In addition, regulatory agencies may not approve the labeling claims that are necessary
or desirable for the successful commercialization of our product candidates. Delays or failure to obtain necessary regulatory
approvals could have a material adverse effect on our business, results of operations and financial condition.
Even if we obtain regulatory approval for a therapeutic
product candidate, we will remain subject to extensive regulatory scrutiny.
Even if we obtain regulatory approval in the United States for
our therapeutic product candidates, the FDA and other appropriate regulatory agencies may still impose significant restrictions
or delays, including restriction of patient population or indications or additional costly studies. Any changes to the approved
product or its labeling or manufacturing process would require FDA approval. Any advertisements or promotions must comply with
FDA regulations and are subject to FDA review as well as state and federal laws. Drug product manufacturers are subject to continual
review and inspection by the FDA and other regulatory authorities to comply with Current Good Manufacturing Practice standards.
If the FDA or other regulatory authority finds previously undiscovered compliance issues with products, such as unanticipated
adverse effects or issues with the manufacturing facility, the FDA or other regulatory authority may:
|
·
|
issue a
warning letter asserting that we are in violation of law;
|
|
·
|
impose civil
or criminal penalties or monetary fines;
|
|
·
|
suspend
or withdraw regulatory approval;
|
|
·
|
suspend
currently ongoing clinical trials;
|
|
·
|
refuse any
pending applications;
|
|
·
|
prohibit
us from entering into beneficial or necessary contracts such as supply or government
contracts.
|
Any government investigation of alleged violations of law could
require us to expend significant time and resources in response, could result in litigation and litigation-related expense and
could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize
our therapeutic product candidates and generate revenue, which would have a material adverse effect on our business, results of
operations and financial condition.
In addition, even if we obtain regulatory approvals, the timing
or scope of any approvals may prohibit or reduce our ability to commercialize our therapeutic product candidates successfully.
For example, if the approval process takes too long, we may miss market opportunities and give other companies the ability to
develop competing products or establish market dominance. Any regulatory approval that we ultimately obtain may be limited or
subject to restrictions or post-approval commitments that render our products not commercially viable. For example, regulatory
authorities may approve our therapeutic product candidates for fewer or more limited indications than we request, may not approve
the price we intend to charge for our therapeutic product candidates, may grant approval contingent on the performance of costly
post-marketing clinical trials, or may approve our therapeutic product candidates with a label that does not include the labeling
claims necessary or desirable for the successful commercialization of that indication. Further, the FDA may place conditions on
approvals including potential requirements or risk management plans and the requirement for a Risk Evaluation and Mitigation Strategy
(“REMS”) to assure the safe use of the drug. If the FDA concludes a REMS is needed, the sponsor of the NDA must submit
a proposed REMS; the FDA will not approve the NDA without an approved REMS, if required. A REMS could include medication guides,
physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and
other risk minimization tools. Any of these limitations on approval or marketing could restrict the commercial promotion, distribution,
prescription or dispensing of our therapeutic product candidates. Moreover, product approvals may be withdrawn for non-compliance
with regulatory standards or if problems occur following the initial marketing of the product. Any of the foregoing scenarios
could materially harm the commercial success of our product candidates and have a material adverse effect on our business, results
of operations and financial condition.
We may fail to obtain orphan drug status for our therapeutic
product candidates.
We intend to seek orphan drug status from the FDA for those
anti-cancer therapeutic product candidates we are presently developing to the extent such product candidates are eligible for
orphan drug status under the Orphan Drug Act of 1983. The orphan drug status gives the manufacturer specific financial incentives
to develop a pharmacological agent. If a product that has an orphan drug designation receives the first FDA approval for the disease
for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve
any other applications to market the same medication for the same indication, except in very limited circumstances, for seven
years. Failure to obtain an orphan drug designation for our product candidates may have a material adverse effect on our business,
results of operations and financial condition.
Any of our therapeutic product candidates may cause adverse
effects or have properties that could delay or prevent their regulatory approval or limit the scope of any specific indications
or market acceptance.
Adverse events caused by our therapeutic product candidates
could cause interruptions, delays or the halting of our clinical trials. If adverse effects are observed in any clinical trials
for our therapeutic product candidates, we may be unable to obtain timely, or any, regulatory approval of our therapeutic product
candidates. Adverse effects caused by our therapeutic product candidates could also subject us to litigation and liability, which
could have a material adverse effect on our business, results of operations and financial condition.
In addition, if any of our therapeutic product candidates are
approved for commercialization and are found to cause serious or unpredicted side effects, serious consequences may result, including
but not limited to, the withdrawal of marketing approval by regulatory authorities, restrictions on distribution by regulatory
authorities, the need to conduct additional clinical trials, litigation and potential liability for personal injury to patients
and damage to our reputation. Furthermore, our ability to achieve and maintain profitability may be permanently impaired. Any
of these events could have a material adverse effect on our business, results of operations and financial condition.
Our dietary supplements are subject to government regulation,
both in the United States and internationally, which could increase our costs significantly and limit or prevent the sale of our
dietary supplements.
The
manufacture, packaging, labeling, advertising, promotion, distribution and sale of Cannabics SR, and any
other dietary supplements that we may develop and commercialize, is subject to regulation by numerous national and local governmental
agencies in the United States and other countries, including the FDA and Federal Trade Commission in the United States, and the
Ministry of Health in Israel. Failure to comply with these regulatory requirements may result in various types of penalties or
fines. These include injunctions, product withdrawals, recalls, product seizures, fines and criminal prosecutions. Individual
states also regulate dietary supplements. A U.S. state may interpret claims or products presumptively valid under federal law
as illegal under that state’s regulations. In markets outside the United States, we will likely be required to obtain approvals,
licenses, or certifications from a country’s ministry of health or comparable agency, as well as labeling and packaging
regulations, all of which vary from country to country. Approvals or licensing may be conditioned on reformulation of products
or may be unavailable with respect to certain products or product ingredients. Any of these government agencies, as well as legislative
bodies, can change existing regulations, or impose new ones, or
could take aggressive measures, causing or contributing
to a variety of negative consequences, including:
|
·
|
requirements
for the reformulation of certain or all products to meet new standards;
|
|
·
|
the
recall or discontinuance of certain or all products;
|
|
·
|
additional
record keeping;
|
|
·
|
expanded
documentation of the properties of certain or all products;
|
|
·
|
expanded
or different labeling;
|
|
·
|
adverse
event tracking and reporting; and
|
|
·
|
additional
scientific substantiation.
|
Any or all of these requirements could have a material adverse
effect on us. There can be no assurance that the
regulatory environment
in which we operate will not change or that such regulatory environment, or any specific action taken against us, will not result
in a material adverse effect on us.
Changes in legislation or regulation in the health care
systems in the United States and foreign jurisdictions may affect us.
Our ability to successfully commercialize our cannabinoid-based
products may depend on how the healthcare systems of the United States, the European Union and other governments provide coverage
or reimbursement. Reimbursement and healthcare payment systems in international markets vary significantly by country, and include
both government sponsored healthcare and private insurance. To obtain reimbursement or pricing approval in some countries, we
may be required to produce clinical data, which may involve one or more clinical trials, that compares the cost-effectiveness
of our products to other available therapies. We may not obtain international reimbursement or pricing approvals in a timely manner,
if at all. Our failure to receive international reimbursement or pricing approvals would negatively impact market acceptance of
our products in the international markets in which those approvals are sought.
We believe that future reimbursement may
be subject to increased restrictions in the United States, the European Union and in other international markets. There is increasing
pressure by governments worldwide to contain health care costs by limiting both the coverage and the level of reimbursement for
therapeutic products and by refusing, in some cases, to provide any coverage for products that have not been approved by the relevant
regulatory agency. Future legislation, regulation or reimbursement policies of third party payers may adversely affect the demand
for our product candidates currently under development and limit our ability to sell our product candidates on a profitable basis.
In addition, third party payers continually attempt to contain or reduce the costs of healthcare by challenging the prices charged
for healthcare products and services. If reimbursement for our products is unavailable or limited in scope or amount or if pricing
is set at unsatisfactory levels, market acceptance of our products candidates will be impaired and future revenues, if any, will
be adversely affected.
Risks Related to Our Dependence on Third Parties
We rely and expect to continue to rely heavily on third
parties to conduct our preclinical studies and clinical trials, and those third parties may not perform satisfactorily, including
failing to meet deadlines for the completion of such studies and trials.
We do not have in-house research facilities and, as a consequence,
we must currently rely on third parties to conduct our clinical trials. We expect to continue to rely heavily on third parties,
such as contract research organizations, clinical data management organizations, medical institutions, clinical investigators
and others to conduct our clinical trials. Our agreements with these third parties generally allow the third party to terminate
our agreement with them at any time. If we are required to enter into alternative arrangements because of any such termination,
the introduction of our product candidates to market could be delayed.
Our reliance on third parties for research and development will
reduce our control over such activities but will not relieve us of our responsibilities. Likewise, our reliance on third parties
whom we do not control does not relieve us of our responsibility to comply with regulatory requirements to use Current Good Clinical
Practice standards when conducting, recording and reporting the results of clinical trials in order to ensure that data and reported
results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. We are
also required to register ongoing clinical trials and post the results of completed clinical trials on a government-sponsored
database of regulatory agencies within specified timeframes. Failure to do so can result in fines, adverse publicity and civil
and criminal sanctions.
The third parties on whom we rely may also have relationships
with other entities, some of whom may be our competitors. If these third parties do not successfully carry out their contractual
duties, meet expected deadlines or conduct our clinical trials in accordance with the requirements of a regulatory agency or our
stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for our product candidates
and will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates.
Collaboration agreements that we may enter into in the
future may not be successful, which could adversely affect our ability to develop and commercialize our diagnostics and therapeutic
product candidates.
We may enter into collaboration agreements with pharmaceutical
companies and biotechnology institutions for the development or commercialization of our cannabinoid-based diagnostics and therapeutic
product candidates, which agreements may contain provisions based upon, among other things, the merits of retaining certain rights.
We will face significant competition in seeking appropriate collaborators and in negotiating agreements at acceptable terms, if
at all. We may not be successful in our efforts to enter, implement and maintain collaboration agreements. Disagreements stemming
from collaboration agreements concerning development, intellectual property, regulatory or commercialization matters can lead
to delays and, in some cases, termination of our collaboration agreements or otherwise result in the potentially significant costs
and fees in seeking to enforce or protect our rights, if any. Any such disagreements can be difficult if, in fact, neither of
the parties has final decision making authority. The resulting outcome of any disputes or disagreements would in all likelihood
adversely affect our business.
Data provided by collaborators and others upon which we
rely that has not been independently verified could turn out to be false, misleading, or incomplete.
We rely on third-party vendors, scientists, and collaborators
to provide us with significant data and other information related to our projects, clinical trials, and our business. If such
third parties provide inaccurate, misleading, or incomplete data, our business, prospects, and results of operations could be
materially adversely affected.
Our business model is substantially dependent on third
party licensees to market and sell our products, which will subject us to a number of risks.
We depend on third party licensees to sell, market, and service
our products and current and future products in our intended markets. We are subject to a number of risks associated with reliance
upon third party licensees, including:
|
·
|
lack of
day-to-day control over the activities of licensees;
|
|
·
|
third party
licensees may not commit the necessary resources to market and sell our current and future
products to our level of expectations;
|
|
·
|
third party
licensees may terminate their arrangements with us on limited or no notice or may change
the terms of these arrangements in a manner unfavorable to us; and
|
|
·
|
disagreements
with our future licensees could result in costly and time-consuming litigation or arbitration
which we could be required to conduct in jurisdictions with which we are not familiar.
|
If we fail to establish and maintain satisfactory relationships
with our future third party licensees, our revenue and market share may not grow as anticipated, and we could be subject to unexpected
costs which could harm our results of operations and financial condition.
Risks Related To Operating In Israel
Failure to secure the necessary Israeli licenses to use
cannabis for medical research could limit our ability to execute our research and development activities, delay the launch of
our products and adversely affect the results of our business operations.
To date, we have only conducted our research in Israel and,
in fact, have limited our operations to Israel. The biotechnologies that we are developing contain cannabis, a “controlled
substance” as defined in the Israeli Dangerous Drugs Ordinance [New Version], 5733 - 1973. In Israel, licenses to cultivate,
possess and to use cannabis for medical research are granted by the Ministry of Health, Israel Medical Cannabis Unit (“IMCU”),
on an
ad hoc
basis. We have obtained all IMCU licenses that are necessary for us to carry out our research. Even though
we have an established track record of successfully obtaining the requisite licenses as required, there can be no assurance that
we will continue to be able to secure licenses in the future. If we fail to comply with Israeli rules and regulations related
to the licensing of cannabis, we may not be able to research and develop our product candidates as we intend or at all.
We may become subject to claims for remuneration or royalties
for assigned service invention rights by our employees, which could result in litigation and adversely affect our business.
A significant portion of our intellectual property has been
developed by our Israeli employees in the course of their employment for us. Under the Israeli Patent Law, 5727-1967 (the “Israeli
Patent Law”), inventions conceived of by an employee during the term and as part of the scope of his or her employment with
a company are regarded as “service inventions,” which belong to the employer, absent a specific agreement between
the employee and employer giving the employee service invention rights. The Israeli Patent Law also provides that if there is
no such agreement between an employer and an employee, the Israeli Compensation and Royalties Committee (the “C&R Committee”),
a body constituted under the Israeli Patent Law, shall determine whether the employee is entitled to remuneration for his or her
inventions. The C&R Committee (decisions of which have been upheld by the Israeli Supreme Court) has held that employees may
be entitled to remuneration for their service inventions despite having specifically waived any such rights. Further, the C&R
Committee has not yet set specific guidelines regarding the method for calculating this remuneration or the criteria or circumstances
under which an employee’s waiver of his or her right to remuneration will be disregarded. We generally enter into intellectual
property assignment agreements with our employees pursuant to which such employees assign to us all rights to any inventions created
in the scope of their employment or engagement with us. Although our employees have agreed to assign to us service invention rights
and have specifically waived their right to receive any special remuneration for such assignment beyond their regular salary and
benefits, we may face claims demanding remuneration in consideration for assigned inventions. As a consequence of such claims,
we could be required to pay additional remuneration or royalties to our current or former employees, or be forced to litigate
such claims, which could negatively affect our business.
We expect that our results of operations will be subject
to fluctuations in currency exchange rates because a substantial portion of our anticipated revenue will be generated in U.S.
dollars and Euros while a significant portion of our expenses will be incurred in New Israeli Shekels.
We expect a substantial portion of our revenue will be generated
in U.S. dollars and Euros, while a significant portion of our expenses, principally salaries and related personnel expenses, is
paid in New Israeli Shekels, or NIS. As a result, we are exposed to the risk that the rate of inflation in Israel will exceed
the rate of devaluation of the NIS in relation to the Euro or the U.S. dollar, or that the timing of this devaluation will lag
behind inflation in Israel. Because inflation has the effect of increasing the U.S. dollar and Euro costs of our operations, it
would therefore have an adverse effect on our dollar-measured results of operations. The value of the NIS, against the Euro, the
U.S. dollar, and other currencies may fluctuate and is affected by, among other things, changes in Israel’s political and
economic conditions. Any significant revaluation of the NIS may materially and adversely affect our cash flows, revenues and financial
condition. Fluctuations in the NIS exchange rate, or even the appearance of instability in such exchange rate, could adversely
affect our ability to operate our business.
We may not be able to enforce covenants not-to-compete
under current Israeli law.
We have non-competition agreements with most of our employees,
all of which are governed by Israeli law. These agreements generally prohibit our employees from competing with us or working
for our competitors for a specified period following termination of their employment. However, Israeli courts are reluctant to
enforce non-compete undertakings of former employees and tend, if at all, to enforce those provisions for relatively brief periods
of time in restricted geographical areas and only when the employee has unique value specific to that employer’s business
and not just regarding the professional development of the employee. Any such inability to enforce non-compete covenants may cause
us to lose any competitive advantage arising from confidential information known to such former employees.
It may be difficult for investors in the United States
to enforce any judgments obtained against us or some of our directors or officers.
The majority of our assets are located outside the United States.
In addition, certain of our officers are nationals or residents of countries other than the United States, and all or a substantial
portion of such persons’ assets are located outside the United States. As a result, it may be difficult for investors to
enforce within the United States any judgments obtained against us or any of our non-U.S. officers, including judgments predicated
upon the civil liability provisions of the securities laws of the United States or any state thereof. It may also be difficult
to assert claims under United States securities law in actions originally instituted outside of the United States. Moreover, Israeli
courts may refuse to hear a United States securities law claim because Israeli courts may not be the most appropriate forums in
which to bring such a claim. Even if an Israeli court agrees to hear a claim, it may determine that Israeli law, and not U.S.
law, is applicable to the claim. Further, if U.S. law is found to be applicable, certain content of applicable U.S. law must be
proved as a fact, which can be a time-consuming and costly process, and certain matters of procedure would still be governed by
Israeli law. Consequently, our investors may be effectively prevented from pursuing remedies under U.S. federal and state securities
laws against us or any of our non-U.S. directors or officers.
If there are significant shifts in the political, economic
and military conditions in Israel and its neighbors, it could have a material adverse effect on our business relationships and
profitability.
All of our research facilities and certain of our key personnel
are located in Israel. Our business is directly affected by the political, economic and military conditions in Israel and its
neighbors. Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and
its Arab neighbors. A state of hostility, varying in degree and intensity, has caused security and economic problems in Israel.
Although Israel has entered into peace treaties with Egypt and Jordan, and various agreements with the Palestinian Authority,
there has been a marked increase in violence, civil unrest and hostility, including armed clashes, between the State of Israel
and the Palestinians since September 2000. The establishment in 2006 of a government in the Gaza Strip by representatives of the
Hamas militant group has created heightened unrest and uncertainty in the region. In mid-2006, Israel engaged in an armed conflict
with Hezbollah, a Shiite Islamist militia group based in Lebanon, and in June 2007, there was an escalation in violence in the
Gaza Strip. From December 2008 through January 2009 and again in November and December 2012, Israel engaged in an armed conflict
with Hamas, which involved missile strikes against civilian targets in various parts of Israel and negatively affected business
conditions in Israel. In July 2014, Israel launched an additional operation against Hamas operatives in the Gaza strip in response
to Palestinian groups launching rockets at Israel. Recent political uprisings and social unrest in Syria are affecting its political
stability, which has led to the deterioration of the political relationship between Syria and Israel and have raised new concerns
regarding security in the region and the potential for armed conflict. Similar civil unrest and political turbulence is currently
ongoing in many countries in the region. The continued political instability and hostilities between Israel and its neighbors
and any future armed conflict, terrorist activity or political instability in the region could adversely affect our operations
in Israel and adversely affect the market price of our shares of common stock. In addition, several countries restrict doing business
with Israel and Israeli companies have been and are today subjected to economic boycotts. The interruption or curtailment of trade
between Israel and its present trading partners could adversely affect our business, financial condition and results of operations.
Risks Related To Our Stock
There can be no assurance of an active, liquid and orderly
trading market for our common stock or that investors will be able to sell their shares of common stock.
At present, our common stock is quoted on the OTCQB tier of
the marketplace maintained by OTC Markets Group Inc., under the symbol “CNBX.” There is only a limited, liquid public
trading market for our common stock. There can be no assurance that a liquid market for our common stock will continue. Market
liquidity will depend on the perception of our business and any steps that our management might take to bring public awareness
of our business to the investing public within the parameters of the federal securities laws. There is no assurance that any such
awareness will be generated or sustained. Therefore, investors may not be able to liquidate their investment or liquidate it at
a price paid by investors equal to or greater than their initial investment in our common stock. Moreover, holders of our common
stock may not find purchasers for their shares should they to decide to sell the common stock held by them at any particular time
if ever. Our common stock should be purchased only by investors who have no immediate need for liquidity in their investment and
who can hold our common stock, possibly for a prolonged period of time.
The price of our common stock is volatile, and the value
of your investment could decline.
The market price of our common stock has been highly volatile.
Between September 1, 2016, and February 28, 2017, the sales price of our stock on the OTCQB ranged from a low of $0.04 per share
to a high of $7.60 per share. Accordingly, it is difficult to forecast the future performance of our common stock. The market
price of our common stock may be higher or lower than the price you pay, depending on many factors, some of which are beyond our
control and may not be related to our operating performance. These fluctuations could cause you to lose all or part of your investment
in our common stock. Factors that could cause fluctuations in the trading price of our common stock include the following:
|
•
|
technological innovations or
new products and services by us or our competitors;
|
|
•
|
regulatory developments at the
federal, state or local level;
|
|
•
|
additions or departures of key
personnel;
|
|
•
|
our ability to execute our business
plan;
|
|
•
|
operating results that fall below
expectations;
|
|
•
|
loss of any strategic relationship;
|
|
•
|
economic, political and other
external factors; and
|
|
•
|
period-to-period fluctuations
in our financial results.
|
The stock market generally and in particular, the market for
stocks of biotechnology companies with lower market capitalizations, like us, have from time to time experienced, and likely will
again experience significant price and volume fluctuations that are unrelated to the operating performance of a particular company.
The trading price of our common stock might decline in reaction to events that affect other companies in our industry, even if
these events do not directly affect us.
Periods of volatility in the market price of a company’s
securities have often been followed by securities class action litigation against that company. If our stock price continues to
be volatile, we may become the target of securities litigation, which could result in substantial costs and divert our management’s
attention and resources from our business. This could have a material adverse effect on our business, operating results and financial
condition.
We may never pay any dividends to our shareholders.
We currently intend to retain any future earnings for use in
the operation and expansion of our business. Accordingly, we do not expect to pay any dividends in the foreseeable future, but
will review this policy as circumstances dictate. The declaration and payment of all future dividends, if any, will be at the
sole discretion of our board of directors, which retains the right to change our dividend policy at any time. Consequently, our
stockholders must rely on sales of their common stock after price appreciation, which may never occur, as the only way to realize
any future gains on their investment.
Our principal stockholders and management own a significant
percentage of our stock and will be able to exert significant control over matters subject to stockholder approval.
As at August 31, 2016, Cannabics Inc., a Delaware corporation,
owns 82% of our common stock. Our Chief Executive Officer and our Chief Technical Officer, who are both also directors, collectively
own 39.35% of Cannabics Inc., and therefore have substantial influence over it. Accordingly, the Company (and our management)
may be able to control the outcome of stockholder votes, including votes concerning the election of directors, amendment of our
organizational documents, approval of mergers, sales of assets and other significant corporate transactions. This concentration
of ownership in Cannabics Inc. (and our management) may have the effect of delaying or preventing a change in our management and
voting control of Cannabics Inc., including preventing or discouraging unsolicited acquisition proposals or offers for our common
stock that some of our stockholders may believe is in their best interest.
We may issue shares of preferred stock with greater rights
than our common stock, which may entrench management and result in dilution of our stockholders' investment.
Our Articles of Incorporation authorize the issuance of up to
100 million shares of preferred stock, par value $0.0001 per share. The authorized but unissued preferred stock may be issued
by our board of directors from time to time on any number of occasions, without stockholder approval, as one or more separate
series of shares comprised of any number of the authorized but unissued shares of preferred stock, designated by resolution of
our board of directors stating the name and number of shares of each series and setting forth separately for such series the relative
rights, privileges and preferences thereof, including, if any, the: (i) rate of dividends payable thereon; (ii) price, terms and
conditions of redemption; (iii) voluntary and involuntary liquidation preferences; (iv) provisions of a sinking fund for redemption
or repurchase; (v) terms of conversion to common stock, including conversion price, and (vi) voting rights. Such preferred stock
may enable our board of directors to hinder or discourage any attempt to gain control of the Company by a merger, tender offer
at a control premium price, proxy contest or otherwise. Consequently, the preferred stock could entrench our management. The market
price of our common stock could be depressed by the existence of the preferred stock.
Nevada law and certain provisions of our Articles of Incorporation
and bylaws may discourage mergers and other transactions.
Provisions of Nevada law, such as its business combination statute,
and certain provisions of our Articles of Incorporation and by-laws could make it more difficult for someone to acquire control
of the Company and limit the price that certain investors might be willing to pay for shares of our common stock. These provisions
may make it more difficult for stockholders to take certain corporate actions and could delay or prevent someone from acquiring
our business. The provisions could be beneficial to our management and the board of directors in a hostile tender offer, and could
have an adverse impact on stockholders who might want to participate in such tender offer, or who might want to replace some or
all of the members of the board of directors.
Our common stock may be subject to penny stock rules, which
may make it more difficult for our investors to sell their common stock.
Our common stock is presently considered to be a "penny
stock" and is subject to SEC rules and regulations that impose limitations upon the manner in which such shares may be publicly
traded, and regulate broker-dealer practices in connection with transactions in "penny stocks." Penny stocks generally
are equity securities with a price of less than $5.00 (other than securities registered on certain national securities exchanges
or quoted on the NASDAQ system, provided that current price and volume information with respect to transactions in such securities
is provided by the exchange or system). The penny stock rules require a broker-dealer, prior to a transaction in a penny stock
not otherwise exempt from the rules, to deliver a standardized risk disclosure document that provides information about penny
stocks and the risks in the penny stock market. The broker-dealer must also provide the customer with current bid and offer quotations
for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction, and monthly account statements
showing the market value of each penny stock held in the customer's account. In addition, the penny stock rules generally require
that prior to a transaction in a penny stock, the broker-dealer make a special written determination that the penny stock is a
suitable investment for the purchaser and receive the purchaser's written agreement to the transaction. These disclosure requirements
may have the effect of reducing the level of trading activity in the secondary market for a stock that becomes subject to the
penny stock rules which may increase the difficulty investors may experience in attempting to liquidate such securities. These
requirements could also hamper our ability to raise funds in the primary market for our shares of common stock.