NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
A.
|
Organizational
Background
|
OWC
Pharmaceutical Research Corp. (“OWCP” or the “Company”) is a Delaware corporation and was incorporated
under the laws of the State of Delaware on March 7, 2008. On July 6, 2014, the Company established a wholly-owned subsidiary,
One World Cannabis Ltd. (“OWC” or the “Israeli subsidiary”) under the laws of the State of Israel. The
Company is a medical cannabis research and development company that applies conventional pharmaceutical research protocols and
disciplines to the field of medical cannabis with the objective of establishing a leadership position in the research and development
of medical cannabis therapies, products and delivery technologies. The Company is currently engaged in the research and development
of cannabis-based medical products (the “Product Prospects”) for the treatment of multiple myeloma, psoriasis and
fibromyalgia as well as development of a cannabis soluble tablet delivery system and topical cream for localized external treatment
that may have applications for other indications. The Company also provides consulting services to governmental and private entities
to assist them with developing and implementing tailor-made comprehensive medical cannabis programs.
|
B.
|
Liquidity
and going concern uncertainty
|
The
development and commercialization of the Company’s product is expected to require substantial expenditures. The Company
has not yet generated material revenues from operations, and therefore is dependent upon external sources for financing its operations.
As of June 30, 2017, the Company has an accumulated deficit of $11,838,959, and its stockholders’ equity is $1,237,157.
In addition, in each year since its inception the Company has reported losses and negative cash flows from operating activities.
Management considered the significance of such conditions in relation to the Company’s ability to meet its current and future
obligations and determined that such conditions raise substantial doubt about the Company’s ability to continue as a going
concern. The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability
and classification of assets or the amounts and classification of liabilities that may result from the possible inability of the
Company to continue as a going concern. Until such time as the Company generates sufficient revenue to fund its operations (if
ever), the Company plans to finance its operations through the sale of equity or equity-linked securities and/or debt securities
and, to the extent available, short-term and long-term loans. There can be no assurance that the Company will succeed in obtaining
the necessary financing to continue its operations as a going concern.
During
the first six months of 2017, the Company raised a total amount of $1,667,524 (net of related expenses), from the issuance of
units that included Common Stock and detachable warrants. In addition, during 2017 the Company received $77,083 through the exercise
of warrants.
As
described in the above paragraph, the Company has a limited operating history and faces a number of risks and uncertainties, including
risks and uncertainties regarding continuation of the development process, demand and market acceptance of the Company’s
products, the effects of technological changes, competition and the development of products by competitors. Additionally, other
risk factors also exist, such as the ability to manage growth and the effect of planned expansion of operations on the Company’s
future results and the availability of necessary financing. In addition, the Company expects to continue incurring significant
operating costs and losses in connection with the development and marketing of its products. The Company has not yet generated
material revenues from its operations to fund its activities and therefore is dependent on the receipt of additional funding from
its stockholders and/ or new investors in order to continue its operations.
OWC
PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)
The
preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates
and assumptions that affect reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at
the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results
could differ from the estimates. As applicable to these consolidated financial statements, the most significant estimates and
assumptions relate to (i) Stock based compensation and (ii) the going concern assumptions.
NOTE
2 -
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES
|
Accounting
Principles
The
accompanying unaudited condensed consolidated financial statements and related notes should be read in conjunction with our consolidated
financial statements and related notes contained in our Annual Report on Form 10-K for the fiscal year ended December 31, 2016.
The unaudited condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the
Securities and Exchange Commission (“SEC”) related to interim financial statements. As permitted under those rules,
certain information and footnote disclosures normally required or included in financial statements prepared in accordance with
U.S. GAAP have been condensed or omitted. The financial information contained herein is unaudited; however, management believes
all adjustments have been made that are considered necessary to present fairly the results of the Company’s financial position
and operating results for the interim periods. All such adjustments are of a normal recurring nature.
The
results for the three and six months ended June 30, 2017 are not necessarily indicative of the results to be expected for the
year ending December 31, 2017 or for any other interim period or for any future period.
Principles
of Consolidation
The
consolidated financial statements include the accounts of the Company and its subsidiary. All intercompany balances and transactions
have been eliminated in consolidation.
Certain
reclassifications from the prior year presentation have been made to conform to the current year presentation. These reclassifications
did not have material impact on the Company’s equity, net assets, results of operations or cash flows.
OWC
PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)
NOTE
2 -
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES (cont.)
|
|
C.
|
Recently
Issued Accounting Standards
|
|
1.
|
Effective
January, 2017, the Company adopted Accounting Standards Update (ASU) No. 2015-17, Income
Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes, which changes how
deferred taxes are classified on organizations’ balance sheet. The ASU eliminates
the current requirement for organizations to present deferred tax liabilities and assets
as current and noncurrent in a classified balance sheet. Instead, all deferred tax assets
and liabilities will be required to be classified as noncurrent. The amendments apply
to all organizations that present a classified balance sheet. For public companies, the
amendments are effective for financial statements issued for annual periods beginning
after December 15, 2016, and interim periods within those annual periods (i.e., in the
first quarter of 2017 for calendar year-end companies).Early adoption is permitted for
all entities as of the beginning of an interim or annual reporting period. The guidance
may be applied either prospectively, for all deferred tax assets and liabilities, or
retrospectively (i.e., by reclassifying the comparative balance sheet). If applied prospectively,
entities are required to include a statement that prior periods were not retrospectively
adjusted. If applied retrospectively, entities are also required to include quantitative
information about the effects of the change on prior periods. The adoption of this ASU
did not have a significant impact on the consolidated financial statements.
|
|
2.
|
Effective
January, 2017, the Company adopted Accounting Standards Update (ASU) No. 2016-09, Compensation
- Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting.
The amendments are intended to improve the accounting for employee share-based payments
and affect all organizations that issue share-based payment awards to their employees.
|
Several
aspects of the accounting for share-based payment award transactions are simplified, including: (a) income tax consequences; (b)
classification of awards as either equity or liabilities; and (c) classification on the statement of cash flows. The amendments
also simplify two areas specific to private companies.
For
public companies, the amendments are effective for annual periods beginning after December 15, 2016, and interim periods within
those annual periods. Early adoption is permitted in any interim or annual period periods (i.e., in the first quarter of 2017
for calendar year-end companies).
The
adoption of this ASU did not have a significant impact on the consolidated financial statements.
|
3.
|
In
May 2014, The FASB issued Accounting Standards Update 2014-09
, Revenue from Contracts
with Customers (Topic 606)
(“ASU 2014-09”).
|
ASU
2014-09 outlines a single comprehensive model to use in accounting for revenue arising from contracts with customers and supersedes
most current revenue recognition guidance, including industry-specific guidance. ASU 2014-09 also requires entities to disclose
sufficient information, both quantitative and qualitative, to enable users of financial statements to understand the nature, amount,
timing, and uncertainty of revenue and cash flows arising from contracts with customers.
During
2016, the FASB issued several Accounting Standard Updates that focuses on certain implementation issues of the new revenue recognition
guidance including Narrow-Scope Improvements and Practical Expedients, Principal versus Agent Considerations and Identifying Performance
Obligations and Licensing.
An
entity should apply the amendments in this ASU using one of the following two methods: 1. Retrospectively to each prior reporting
period presented with a possibility to elect certain practical expedients, or, 2. Retrospectively with the cumulative effect of
initially applying ASU 2014-09 recognized at the date of initial application. If an entity elects the latter transition method,
it also should provide certain additional disclosures.
OWC
PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)
NOTE
2 -
|
SUMMARY
OF SIGNIFICANT ACCOUNTING POLICIES (cont.)
|
|
C.
|
Recently
Issued Accounting Standards (cont.)
|
For
a public entity, the amendments in ASU 2014-09 (including the amendments introduced through recent ASU’s) are effective
for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period (the first
quarter of fiscal year 2018 for the Company). Early application is permitted only as of annual reporting periods beginning after
December 15, 2016, including interim reporting periods within that reporting period.
The
Company intends to adopt ASU 2014-09 as of January 1, 2018.
The
Company is in the process of evaluating the impact of ASU 2014-09 on its revenue streams and selling contracts, if any, and on
its financial reporting and disclosures. Management is expecting to complete the evaluation of the impact of the accounting and
disclosure changes on the business processes, controls and systems throughout 2017. Since the Company did not report so far, material
revenues, management believes that the adoption of ASU 2014-09 will not have significant impact on its financial statements.
|
4.
|
Accounting
Standards Update (ASU) No. 2017-11,
Earnings Per Share (Topic 260); Distinguishing
Liabilities from Equity (Topic 480);Derivatives and Hedging (Topic 815)
: (Part I)
Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement
of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain
Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a
Scope Exception
|
In
July 2017, the FASB has issued Accounting Standards Update (ASU) No. 2017-11,
Earnings Per Share (Topic 260); Distinguishing
Liabilities from Equity (Topic 480);Derivatives and Hedging (Topic 815)
: (Part I) Accounting for Certain Financial Instruments
with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of
Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (ASU 2017-11).
Among
others, Part I of ASU 2017-11 simplifies the accounting for certain financial instruments with down round features, a provision
in an equity-linked financial instrument (or embedded feature) that provides a downward adjustment of the current exercise price
based on the price of future equity offerings. Current accounting guidance creates cost and complexity for organizations that
issue financial instruments with down round features by requiring, on an ongoing basis, fair value measurement of the entire instrument
or conversion option.
ASU
2017-11 require companies to disregard the down round feature when assessing whether the instrument is indexed to its own stock,
for purposes of determining liability or equity classification. Companies that provide earnings per share (EPS) data will adjust
their basic EPS calculation for the effect of the feature when triggered (i.e., when the exercise price of the related equity-linked
financial instrument is adjusted downward because of the down round feature) and will also recognize the effect of the trigger
within equity.
ASU
2017-11 also addresses navigational concerns within the FASB Accounting Standards Codification related to an indefinite deferral
available to private companies.
The
provisions of the new ASU related to down rounds are effective for public business entities for fiscal years, and interim periods
within those fiscal years, beginning after December 15, 2018 (fiscal 2019 for the Company). Early adoption is permitted for all
entities.
The
Company hasn’t began evaluating the impact of part I of ASU 2017-11 on its financial statements.
OWC
PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)
NOTE
3 –
|
EVENTS
DURING THE PERIOD
|
|
A
|
Common
stock and Warrants Issued for cash
|
|
1.
|
During
the period, the Company received $117,640 through a placement of 904,924 common stock
units to four investors for the offering price of $0.13 per unit. Each unit consisted
of one share of common stock and two (one “G” and one “H”) warrants
to purchase one share of common stock. The 904,924 “G” warrants are exercisable
at $0.25 and expire two years from the date of issuance. The 904,924 “H”
warrants are exercisable at $0.40 and expire three years from the date of issuance. Such
warrants were classified within stockholders’ equity.
|
|
2.
|
During
the period, the Company received $100,000 through a placement of 588,237 common stock
units to three investors for the offering price of $0.17 per unit. Each unit consisted
of one share of common stock and one “H” warrant to purchase one share of
common stock. The 588,237 “H” warrants are exercisable at $0.40 and expire
three years from the date of issuance. Such warrants were classified within stockholders’
equity
|
|
3.
|
During
the period, the Company received $130,000 through a placement of 520,000 common stock
units to five investors for the offering price of $0.25 per unit. Each unit consisted
of one share of common stock and one “I” warrant to purchase one share of
common stock. The 520,000 “I” warrants are exercisable at $0.50 and expire
two years from the date of issuance. Such warrants were classified within stockholders’
equity.
|
|
4.
|
During
the period, the Company received $883,624 through a placement of 1,767,250 common stock
units to twenty investors for the offering price of $0.50 per unit. Each unit consisted
of one share of common stock and one “K” warrant to purchase one share of
common stock. The 1,767,250 “K” warrants are exercisable at $1.00 and expire
eighteen months from the date of issuance. Such warrants were classified within stockholders’
equity.
|
|
5.
|
During
the period, the Company received $436,260 through a placement of 623,227 common stock
units to eleven investors for the offering price of $0.70 per unit. Each unit consisted
of one share of common stock and one “K” warrant to purchase one share of
common stock. The 1,734,000 “K” warrants are exercisable at $1.00 and expire
eighteen months from the date of issuance. Such warrants were classified within stockholders’
equity.
|
|
B.
|
Stock-based
compensation
|
|
1.
|
During
the period, the Company issued 300,000 fully vested shares of the Company common stock
and 400,000 warrants (200,000 “G” warrants with exercise price of $0.25 and
200,000 “H” warrants with exercise price of $0.40) for the purchase of one
share each of common stock to a consultant as payment for services. As the equity instruments
issued are fully vested and non-forfeitable, the fair value of the grant was recognized
as an increase to stockholders’ equity at the measurement date with an offsetting
amount as a deduction from stockholders’ equity within the caption “Services
receivable”. This amount will be recognized as consulting expense over the terms
of the agreements. The shares were valued at the closing price as of the date of the
agreements ($0.67) and resulted in current recognition as at June 30, 2017, of $83,704
in consulting services expense and $117,296 as future services receivable. This amount
will be recognized as consulting expense over the terms of the agreement. The warrants
were valued using the Black-Scholes-Merton pricing model to estimate the fair value as
at June 30, 2017, of $153,963 and resulted in current recognition of $71,287 in additional
consulting services expense and $82,676 as additional future services receivable. This
amount will be recognized as consulting expense over the terms of the agreement. The
Black-Sholes-Merton pricing model assumptions used are as follows: expected dividend
yield of 0%; risk-free interest rate of 0.10%-.0.11%; expected volatility of 282%, and
warrant exercise period based upon the stated terms. See also C1 below.
|
OWC
PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)
NOTE
3 –
|
EVENTS
DURING THE PERIOD (cont.)
|
|
B.
|
Stock-based
compensation (cont.)
|
|
2.
|
Under
the Bear Creek Corporate Advisory Consulting agreement executed in November of 2016,
the Company became obligated to issue 100,000 additional shares to Bear Creek as of February
28, 2017. The shares were valued at $262,000 and were issued during April 2017.
|
|
3.
|
During
the period, the Company issued 350,000 “E” warrants that are exercisable
at $0.25 and expire two years from the date of issuance to purchase one share each of
the Company’s common stock to two unrelated parties as payment for services. The
aggregate fair value of the warrants was $133,210. As the equity instruments issued are
fully vested and non-forfeitable, the fair value of the grant was recognized as an increase
to stockholders’ equity at the measurement date with an offsetting amount as a
deduction from stockholders’ equity within the caption “Services receivable”.
This amount will be recognized as consulting expense over the terms of the agreements.
The Company recognized $61,678 in current expense and $71,532 remains as services receivable
as of June 30, 2017.
|
The
Company used the Black-Scholes-Merton pricing model to estimate the fair value. The Black-Sholes-Merton pricing model assumptions
used are as follows: expected dividend yield of 0%; risk-free interest rate of 0.10%-.0.11%; expected volatility of 282%, and
warrant exercise period based upon the stated terms.
|
4.
|
During
the period, the Company issued 450,000 fully vested shares of common stock to consultants
as payment for services. The shares were valued at the closing price as of the date of
the agreements ($0.73) and resulted in current recognition of $46,800 in consulting services
expense and $281,700 as future services receivable. This amount will be recognized as
consulting expense over the term of the agreement. The aggregate fair value of the warrants
was $328,500. As the equity instruments issued are fully vested and non-forfeitable,
the fair value of the grant was recognized as an increase to stockholders’ equity
at the measurement date with an offsetting amount as a deduction from stockholders’
equity within the caption “Services receivable”.
|
The
Company used the Black-Scholes-Merton pricing model to estimate the fair value. The Black-Sholes-Merton pricing model assumptions
used are as follows: expected dividend yield of 0%; risk-free interest rate of 0.10%-0.11%; expected volatility of 282%, and warrant
exercise period based upon the stated terms.
|
5.
|
During
the period, the Company issued 416,127 fully vested shares of common stock to a consultant
as payment for services. The shares were valued at the closing price as of the date of
the agreements ($0.89) and resulted in current recognition of $73,056 in consulting services
expense and $297,297 as future services receivable. This amount will be recognized as
consulting expense over the term of the agreement.
|
OWC
PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)
NOTE
3 –
|
EVENTS
DURING THE PERIOD (cont.)
|
|
B.
|
Stock-based
compensation (cont.)
|
|
6.
|
During
the period, the engagement of the Subsidiary’s CEO was terminated and the CFO resigned.
These actions triggered the forfeiture of 10,456,094 options previously granted under
the 2016 Employee Incentive Plan. The forfeitures resulted in the de-recognition of $645,434
of previously recognized compensation expense related to the pre-vested forfeitures.
|
The
following tables present a summary of the status of the grants to employees, officers and directors as of June 30, 2017.
Options
outstanding at December 31, 2016
|
|
|
35,050,000
|
|
|
$
|
0.051
|
|
Forfeited
|
|
|
(10,456,094
|
)
|
|
$
|
0.050
|
|
Options
outstanding at June 30, 2017
|
|
|
24,593,906
|
|
|
$
|
0.051
|
|
Options exercisable
at June 30, 2017
|
|
|
12,423,406
|
|
|
$
|
0.051
|
|
As
such award was subject to a clawback feature in certain contingent events such as termination for cause, the Company accounted
for the cancellation of the award in accordance with the provisions of ASC Topic 718-10-55. Thus, the Company recognized the original
compensation cost related to that grant (which was determined to be less than the current fair value of such award) as a credit
to income statement within line item “General and administrative”.
|
1.
|
During
the period, the consultant mentioned in Note 3B1 above, exercised their 400,000 warrants
and acquired 334,450 shares of common stock. In accordance with the original terms of
the warrant agreement the exercise of the warrants was made on a net share settlement
basis and resulted in delivery to the Company of 65,550 shares by the consultant for
the exercise price, based on the average market value of the common shares ten days period
preceding the date of exercise.
|
|
2.
|
During
the period, the Company received $77,083 in cash for the exercise of 308,334 warrants
to purchase 308,334 shares of common stock. The warrants carried an exercise price of
$0.25.
|
|
3.
|
During
the period, the consultant mentioned in Note 8C1E of the
consolidated
financial statements as at December 31, 2016,
exercised their 400,000 warrants
and acquired 262,363 shares of common stock. In accordance with the original terms of
the warrant agreement the exercise of the warrants was made on a net share settlement
basis and resulted in delivery to the Company of 137,637 shares by the consultant for
the exercise price, based on the average market value of the common shares for the ten
day period preceding the date of exercise.
|
Further
to Note 6 of the consolidated financial statements as at December 31, 2016, OWC received $50,000 from Medmar LLC (“Medmar”)
during February 2017. On April 21, 2017, OWC served written notice to Medmar of OWC’s determination to prepay the non-recourse
loan by Medmar to OWC in the principal amount of $300,000. OWC has elected to exercise what it believes is its absolute right
to terminate certain distribution rights granted to Medmar under the loan agreement and has repaid the entire principal balance
of $300,000, during the period.
OWC
PHARMACEUTICAL RESEARCH CORP. AND SUBSIDIARY
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (cont.)
NOTE
4 -
|
SUBSEQUENT
EVENTS
|
On
August 10, 2017, the Company filed an action in the Supreme Court of the State of New York, New York County seeking to recover
unpaid shares due the Company from former employees Ziv Turner, Uri Geller and Dubi Kochvar. The lawsuit also seeks an injunction
to restrain the sale/transfer of
2,104,480
shares
of the Company’s common stock issued to Ziv Turner by a transferee, Jeffrey Low, and further seeks to rescind the transfer
of shares from Ziv Turner to Jeffrey Low. The action is currently pending and is in the pleading stage.
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION
Back
to Table of Contents
The
following discussion contains forward-looking statements. Forward-looking statements give our current expectations or forecasts
of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts.
The use of words such as “anticipate”, “estimate”, “expect”, “project”, “intend”,
“plan”, “believe”, and other words and terms of similar meaning in connection with any discussion of future
operating or financial performance. From time to time, we also may provide forward-looking statements in other materials we release
to the public.
Plan
of Operations
We
are engaged in research and development of cannabis-based medical products for the treatment of a variety of medical conditions
such as multiple myeloma, psoriasis, fibromyalgia, post-traumatic stress disorder (PTSD) and migraine, and (ii) consulting services
to companies and governmental agencies with respect to complex international medical cannabis protocols and regulations.
We
have not yet commenced any significant activities related to our consulting services.
Recent
Developments
On
September 28, 2016, we entered into a loan agreement (the “Loan Agreement”) with Medmar LLC, pursuant to which Medmar
has agreed to loan us a total of $300,000 (the “Loan”) on a non-interest bearing basis, with no conversion rights.
The Loan is due in 36 months from the Effective Date, September 22, 2016, and repayment shall be made only by the set off of royalties
payable by Medmar to us as follows: (i) prior to the full repayment of the Loan, which OWC Ltd may prepay at any time, if and
to the extent Medmar is required to pay any royalties to OWC under a License Agreement dated March 17, 2016, Medmar shall set
off such royalties from the outstanding principal balance of the Loan; (ii) OWC shall not be required to pay the Loan other than
through the set off from the royalties; and (iii) the Loan is a non-recourse loan, meaning that if and to the extent that the
royalties are insufficient for any reason in order to fully repay the Loan, Medmar waived any right and/or claim to any deficiency.
In
addition, the Loan Agreement also provides that: (i) subject to Medmar funding the entire Loan, Medmar shall receive the exclusive
right to manufacture, produce, publicize, promote and market the OWC’s Licensed Products (as defined in the above-referenced
License Agreement) in any state in the U.S., subject to a new license agreement to be negotiated and signed between the parties
with respect to each and every state; (ii) the rights to be granted to Medmar under (i) above shall expire within three (3) years
subject to certain conditions and limitations; and (iii) the right of first refusal agreement between the parties that was executed
on February 8, 2016 providing Medmar certain rights in connection with the commercialization of Licensed Products in the States
of Hawaii and Pennsylvania be terminated.
On
April 21, 2017, OWC served written notice to Medmar of OWC’s determination to prepay the non-recourse loan by Medmar to
OWC in the principal amount of $300,000. OWC has elected to exercise what it believes is its absolute right to terminate certain
distribution rights granted to Medmar under the loan agreement and has repaid the entire principle balance of $300,000, during
the period.
On
February 1, 2017, following the very encouraging results that have been achieved at the mid-point of the Study, the Registrant’s
Board of Directors and the management and scientific personnel of OWC Ltd have determined to extend the size and scope of the
Study for the purpose of, among other things, checking the biological markers that have been generated to date with respect to
the treatment of psoriasis (proliferation/inhibition and several interleukins). Despite extending its size and scope of the Study,
the Registrant expects to compete the Study within the same projected time frame.
Our
goal is to become a leader in the research and development of cannabis-based medical drugs and treatments. To achieve our goal,
we plan to focus our activities on the following areas:
Research
and Development
Our
research and development is focused primarily on exploring several formulations containing active compounds from the cannabis
plant, including (but not exclusive to) the cannabinoids CBD and THC, and identifying potential therapeutic applications of the
synergistic effects of these active compounds. The synergistic contributions of our formulations have not been scientifically
researched and demonstrated in a preclinical model concerning our topical cream formulation. We aim to standardize the formulations
across the extracts as a whole, not simply by reference to their key active components (CBD and/or THC).
Although
there are existing reports and studies on CBD and THC, our formulations will contain several other active compounds from the cannabis
plant, that must be fully researched and documented in order to verify their effectiveness in specific indications, at what doses
and which method of administration will be the most appropriate and effective.
One
World Cannabis plans to produce pharmaceutical-grade cannabinoid-based products and treatments that will be standardized in composition,
formulation and dose, administered by means of an appropriate and efficient delivery system, and tested in properly controlled
pre-clinical and clinical studies. OWC plans to conduct its research, led by internationally renowned investigators, at the facilities
of leading Israeli hospitals and scientific institutions. The Company will adhere to legislation, rules and guidelines regarding
the investigations. Dr. Yehuda Baruch, OWC’s Director of Research and Regulatory Affairs, and Mr. Alon Sinai, OWC’s
Chief Operating Officer, will monitor the research and studies.
To
date, OWC has signed three research collaboration and license agreements as well as service agreements with Sheba Academic Medical
Center, Tel Hashomer, Israel (“Sheba”), with respect to three potential indications.. Sheba is a university-affiliated
hospital that serves as Israel’s national medical center and the most comprehensive medical center in the Middle East. Within
the framework of the abovementioned agreements with Sheba, as well as other potentially negotiated agreements, OWC intends to
initiate two studies at the Sheba facilities to explore the effect of two formulations, all based on active ingredients in the
cannabis extracts, on multiple myeloma and psoriasis.
The
Company expects to start developing other delivery systems, designed for different indications, during 2017.
Pursuant
to the above mentioned research agreement in connection with the psoriasis indication, the Medical Research Infrastructure Development
and Health Services of the Chaim Sheba Center (the “Fund”) shall perform a Phase I, double blind, randomized, placebo-controlled,
maximal dose study (the “Study”) to determine the safety and tolerability of topical cream containing MGC (“Medical
Grade Cannabis” or the “Study Drug”) in healthy volunteers. Dr. Aviv Barzilay, Director of the Department of
Dermatology at the Chaim Sheba Medical Center will lead the Study (the “Investigator”). The Study as defined in the
Research Agreement, shall be conducted in compliance with the following: (1) the Protocol; (2) the Ministry Guidelines; (3) the
instructions and terms specified in the Helsinki Committee’s approval; (4) the ICH-GCP; (5) the Helsinki Declarations; (6)
the applicable laws, rules and regulations regulating such studies which are applicable in Israel (the “Applicable Laws”);
and (7) written instructions and prescriptions issued by the OWC and governing the administration of the Study Drug.
On
February 1, 2017, following the very encouraging results that were achieved by OWC at the mid-point of the psoriasis related study
conducted by OWC with an Israeli research institute, the Company determined to extend the size and scope of the Study for the
purpose, among other parameters, of checking the biological markers that have been generated to date with respect to the treatment
of psoriasis (proliferation/ inhibition and several interleukins) which was conducted by such institute. Such trial results concluded
that application of OWC’s unique active cannabinoid-based topical cream formulation, resulted in up to 70% improvement in
a variety of inflammation markers directly associated with Psoriasis and inhibition of proliferation.
To
date, One World Cannabis has filed 13 National Phase and 3 PCT patents with the United States Patent and Regulatory Office (USPTO),
all related to its line of activity related to cannabis-based medical products. Assuming the successful completion of the clinical
trials, of which there can be no assurance, the Company believes that it will be able to retain the intellectual rights and secure
patent protections.
While
we retain full ownership on our intellectual property rights that we conceived prior to the signing of the research collaboration
and license agreements with Sheba Academic Medical Center, the psoriasis agreement with Sheba provide that all intellectual property
that is conceived during the course of the research is to be jointly owned by Sheba and One World Cannabis.
Pursuant
to the collaboration agreements, we are expected to pay Sheba $170,000 for conducting the multiple myeloma trial between the 3rd
quarter of 2015 and the second quarter of 2016. Pursuant to the collaboration agreements, we are obliged to pay Sheba $85,000
throughout 2017 for conducting the safety study for the cream for treatment of psoriasis. We currently have the financial resources
to fund our current obligations under these agreements, but anticipate that we will require additional funding during the next
12 months for our continuing and planned expanded operations. As of June 30, 2017, we have paid Sheba $65,669 as per Sheba’s
payment requests.
Research
and Development Status
The
following table summarizes the stages of development for each of our current Product Prospects.
Target
Indication
|
|
Collaborator
|
|
Status
|
|
|
|
|
|
|
Multiple
Myeloma
|
|
Sheba
|
|
●
|
Entered
into a research agreement for in vitro and in vivo studies
|
|
|
Academic
|
|
|
|
|
|
Medical
Center
|
|
●
|
Completed
initial in vitro studies
|
|
|
|
|
|
|
|
|
|
|
●
|
Expect
to negotiate agreement and submit a clinical trial protocol to the Israeli Institutional Review Board and receive its approval
to commence a clinical study
|
|
|
|
|
●
|
Intend
to commence a clinical study referred to above in the second half of 2018
|
|
|
|
|
●
|
Drafted
a clinical trial protocol synopsis, which we believe will assist us in preparing an application for orphan status designation
|
|
|
|
|
|
|
Psoriasis
|
|
Sheba
Academic Medical Center
|
|
●
|
Entered
into a Research Collaboration and License Agreement.
|
|
|
|
|
●
|
Received
an IRB approval for a Phase I, double blind, randomized, placebo controlled, multiple escalating dose study to determine the
safety, tolerability and pharmacokinetic profile of medical grade cannabis in healthy volunteers.
|
|
|
|
|
|
|
Psoriasis
|
|
Emilia
Cosmetics Ltd.
|
|
●
|
Entered
into a nonbinding memorandum of understanding for the development, manufacture and marketing of a cannabinoid-based topical
cream.
|
|
|
|
|
●
|
Completed
the development of the topical cream in the first quarter of 2016.
·
|
|
|
|
|
●
|
Entered
into a final agreement. Pursuant to the License Agreement, Emilia granted a limited license to us with respect to Emilia’s
licensed intellectual property to be developed and commercialized worldwide in the topical treatment of psoriasis in humans
with OWC’s product
|
|
|
|
|
|
|
Fibromyalgia
|
|
Sheba
Academic Medical Center
|
|
●
|
Drafted
a clinical trial protocol synopsis.
|
|
|
|
|
|
|
New
delivery system - cannabis soluble tablet
|
|
G.C.
Group Ltd.
|
|
●
|
Completed
a proof of concept (the R=Research phase) of the desired end product (the soluble tablet) to test the fabric, durability,
solidification and other features of the cannabis soluble tablet.
|
OW
C’s
Investigation on Multiple Myeloma
Dr.
Merav Leiba, Head of Multiple Myeloma Outpatient Clinic and Multiple Myeloma Research Lab at Sheba’s Hematology Institute,
led the in vitro tests on multiple myeloma. Dr. Leiba, a specialist in Internal Medicine and Hematology, was a postdoctoral fellow
at the Jerome Lipper Multiple Myeloma Center at Dana Farber Cancer Institute, Boston, Massachusetts (2006-2008). Dr. Leiba has
participated in numerous clinical and investigational studies aimed at developing novel drugs for multiple myeloma.
Our
tests results on multiple myeloma cells studied in vitro, which we announced on June 17, 2015, led us to proceed with further
pre-clinical studies (safety and toxicity, PK, PD) of our formulation, to has assess the scientific merit for further development
as an investigational new drug. Whilst we are encouraged by the results of the limited in vitro tests, there can be no assurance
that any clinical trial will result in commercially viable products or treatments.
Clinical
trials are expensive, time consuming and difficult to design and implement. We, as well as the regulatory authorities in Israel
and elsewhere, such as an IRB (Helsinki committee), IMCU - Israel Medical Cannabis Unit, or the FDA, may suspend, delay or terminate
our clinical trials at any time, may require us, for various reasons, to conduct additional clinical trials, or may require a
particular clinical trial to continue for a longer duration than originally planned, including, among others:
●
lack of effectiveness of any formulation or delivery system during clinical trials;
● discovery of serious or unexpected toxicities or side effects experienced by trial participants
or other safety issues;
● slower than expected rates of subject recruitment and enrollment rates in clinical trials;
● delays or inability in manufacturing or obtaining sufficient quantities of materials for
use in clinical trials due to regulatory and manufacturing constraints;
● delays in obtaining regulatory authorization to commence a trial, including IRB approvals,
licenses required for obtaining and using cannabis for research, either before or after a trial is commenced;
● unfavorable results from ongoing pre-clinical studies and clinical trials.
● patients or investigators failing to comply with study protocols;
● patients failing to return for post-treatment follow-up at the expected rate;
● sites participating in an ongoing clinical study withdraw, requiring us to engage new sites;
● third-party clinical investigators decline to participate in our clinical studies, do not
perform the clinical studies on the anticipated schedule, or act in ways inconsistent with the established investigator agreement,
clinical study protocol, good clinical practices, and other Institutional Review Board requirements;
● third-party entities do not perform data collection and analysis in a timely or accurate
manner or at all;
● regulatory inspections of our clinical studies require us to undertake corrective action
or suspend or terminate our clinical studies;
Any
of the foregoing could have a material adverse effect on our business, results of operations and financial condition.
Consulting
Services
OWCP
believes that the complexity of the medical cannabis programs has created a demand for consulting and advisory services in different
aspects of the medical cannabis industry. The Company’s services are designed to help government officials, policy-makers
and regulatory agencies develop and implement tailor-made comprehensive medical cannabis programs. In addition, One World Cannabis
offers medical cannabis regulatory compliance services and patient-care consultancy services.
Our
initial activities to secure consulting contracts will be in member states of the European Union and states of the United States
that allow for public medical cannabis programs.
OWC
management has the expertise in designing training programs for physicians, caregivers, and researches that are essential to the
establishment of a successful, patient-focused medical cannabis program. By working with policy-makers, government officials,
public agencies, and privately owned businesses, we believe we can also raise the public’s awareness of the benefits of
cannabis-based treatments and products.
In
furtherance of our plans, we may, in the future, consider strategic acquisitions and joint ventures as well as other projects
to grow our business activities including but not limited to: product licensing and royalty agreements, consulting, and strategic
alliances to support our Product Prospect development. However, there can be no assurance that this strategy will be successful
in generating any revenues or growing our business.
Results
of Operations during the three months ended June 30, 2017 as compared to the three months ended June 30, 2016
We
have not generated any revenue during the three months ended June 30, 2017 and 2016. We have operating expenses related to general
and administrative expenses and research and development. During the three months ended June 30, 2017, we incurred a net loss
of $445,126 due to general and administrative expenses of $231,585, research and development expenses of $211,946 and financial
expenses of $1,595 compared to a net loss of $173,730 due to general and administrative expenses of $84,466 and research and development
expenses of $34,776.
Our
general and administrative expenses increased by $147,119 during the three months ended June 30, 2017 as compared to the same
period in the prior year. This increase of 174% is primarily the result of increase in legal, payroll and consultancy expenses.
Our research and development expenses increased to $211,946 during the three months ended June 30, 2017, compared to $34,776 during
the same period in the prior year. The increase by $177,170 or 509% was primarily due to increase payments related to our
collaboration agreements, consultancy and patent applications.
Results
of Operations during the six months ended June 30, 2017 as compared to the six months ended June 30, 2016
We
have not generated any revenue during the six months ended June 30, 2017 and 2016. We have operating expenses related to general
and administrative expenses and research and development. During the six months ended June 30, 2017, we incurred a net loss of
$1,880,494 due to general and administrative expenses of $1,632,937, research and development expenses of $245,962 and financial
expenses of $1,595 compared to a net loss of $488,118 due to general and administrative expenses of $306,022 and research and
development expenses of $71,819.
Our
general and administrative expenses increased by $1,326,915 during the six months ended June 30, 2017 compared to the same period
in the prior year. This increase of 433% is primarily the result of increase in stock-based compensation and amortization
of services receivable. The charge relating to stock-based compensation expense was $768,936 and for amortization for services
receivable $498,986 for the six months ended June 30, 2017, compared to $8,074 and $0 respectively for the six months ended June
30, 2016.
Our
research and development expenses increased to $245,962 during the six months ended June 30, 2017, compared to $71,819 during
the same period in the prior year. The increase by $174,143 or 242% was primarily due to increase payments related to our
collaboration agreements, consultancy and patent applications.
Liquidity
and Capital Resources
On
June 30, 2017, we had current assets of $1,402,208 consisting of $1,379,895 in cash and other current assets of $22,313. We had
property and equipment valued at $10,568, net of $25,038 in accumulated depreciation, as of June 30, 2017. We had total assets
of $1,412,776 as of June 30, 2017.
On
December 31, 2016, we had current assets of $481,695 consisting of $472,282 in cash and other current assets of $9,413. We had
property and equipment valued at $15,073, net of $21,549 in accumulated depreciation as of December 31, 2016. We had total assets
of $496,768 as of December 31, 2016.
On
June 30, 2017, we had $175,619 in current liabilities consisting of $35,900 in accounts payable, $39,719 in other current liabilities
and deferred revenues of $100,000.
On
December 31, 2016, we had $145,780 in current liabilities consisting of $7,694 in accounts payable, $38,086 in other current liabilities
and deferred revenues of $100,000.
We
had positive working capital of $1,226,589 on June 30, 2017 compared to positive working capital of $335,915 on December 31, 2016.
Our accumulated deficit as of June 30, 2017 and December 31, 2016 were $11,838,959 and $9,958,465, respectively.
We
used $585,914 in our operating activities during the six month ended June 30, 2017, which was due to a net loss of $1,880,494
offset by Amortization of services receivable of $498,986, Stock based compensation of $768,936, depreciation expense of $5,585,
an increase in accounts payable of $28,206, an increase in other assets of $12,900, an increase in foreign currency translation
adjustments of $4,134 and an increase in other liabilities of $1,633.
We
used $264,268 in our operating activities during the six months ended June 30, 2016, which was due to a net loss of $488,118 offset
by an increase in foreign currency translation adjustments of $7,681, an increase in adjustments of convertible loans of $68,717,
depreciation expenses of $4,825, stock based compensation expenses of $8,074, a decrease in accounts receivable of $4,097, a decrease
in other assets of $27,056, an increase in accounts payable of $3,590, an increase in deferred revenues of $100,000 and a decrease
in other liabilities of $190.
We
used $1,080 and $1,860 during the six months ended June 30, 2017 and 2016, respectively, to purchase property and equipment.
Our
financing activities during the six months ended June 30, 2017 provided us with $1,494,607 through proceeds of $1,667,524 from
issuance of common stock, $77,083 from exercise of warrants, $50,000 from non-recourse loan and a repayment of non-recourse
loan of $300,000. Based upon our cash position of $1,379,895 on June 30, 2017, we believe that we have sufficient cash to fund
our operation in the next 12 months, however we believe that in order to execute on our plans we need to raise additional capital,
either equity or debt and there can be no assurance, that additional capital will be sufficient to fund our anticipated expenditure
requirements to execute on our plans.
Our
lack of operating history may make it difficult to raise capital. Our inability to borrow funds or raise equity capital to facilitate
our business plan may have a material adverse effect on our financial condition and future prospects.
Funding
of Our Research Programs
On
October 22, 2014, we entered into a collaboration agreement with Sheba Academic Medical Center, a hospital in Tel-Aviv, Israel,
relating to the use of cannabis to treat Myeloma. Pursuant to the collaboration agreements, we are expected to pay Sheba $170,000
for conducting the multiple myeloma trial between the 3rd quarter of 2015 and the second quarter of 2016. In addition, we commenced
pre-clinical studies on the treatment of psoriasis during the second quarter of 2016. Pursuant to the collaboration agreements,
we are obliged to pay Sheba $85,000 throughout 2017 for conducting the safety study for the cream for treatment of psoriasis.
We currently have the financial resources to fund our current obligations under these agreements, but anticipate that we will
require additional funding during the next 12 months for our continuing and planned expanded operations. As of June 30, 2017,
we have paid Sheba $65,669 according Sheba’s payment requests.
Our
expenditures allocated to our corporate activities conducted through our facilities in Petach Tikva were $39,752 for the year
ended December 31, 2016 and we expect will be approximately $40,000 for the year ending December 31, 2017.
At
present, we use our available working capital to fund these studies. However, we will need to raise additional funding prior to
or if clinical studies are to commence.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Back to
Table of Contents
None.
ITEM
4. CONTROLS AND PROCEDURES
Back to Table of Contents
Evaluation
of Disclosure Controls and Procedures
As
of June 30, 2017, the Company’s chief executive officer and chief financial officer conducted an evaluation regarding the
effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange
Act. Based upon the evaluation of these controls and procedures required by Rules 13a-15 or 15d-15, our chief executive officer
and chief financial officer concluded that our disclosure controls and procedures were ineffective as of the end of June 30, 2017
under the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated Framework (2013).
Changes
in Internal Control Over Financial Reporting
There
were no changes in our internal control over financial reporting or in other factors identified in connection with the evaluation
required by paragraph (d) of Exchange Act Rules 13a-15 or 15d-15 that occurred during the quarter ended June 30, 2017 that have
materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.