OWC Pharmaceutical Research Corp. - Quarter Report: 2015 September (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________
FORM 10-Q
___________________
ý QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2015
Commission file number 0-54856
OWC PHARMACEUTICAL RESEARCH CORP.
(Exact Name Of Registrant
As Specified In Its Charter)
Delaware | 98-0573566 |
(State of Incorporation) | (I.R.S. Employer Identification No.) |
22 Shaham Steet, P.O. Box 8324, Petach Tikva, Israel | 4918103 |
(Address of Principal Executive Offices) | (ZIP Code) |
Registrant's Telephone Number, Including Area Code: +972 (0) 3-758-2657
Indicate by check
mark whether the registrant (1) has filed all reports required to be filed by Section 13
or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant is a shell company (as
defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer (as defined in Rule 12b-2 of the Exchange Act) or a smaller reporting company .
Large accelerated filer ¨ | Accelerated filer ¨ | Non-Accelerated filer ¨ | Smaller reporting company x |
On November 13, 2015, the Registrant had 81,377,541 shares of common stock issued and outstanding.
Item |
Description |
Page |
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PART I - FINANCIAL INFORMATION |
|||||
ITEM 1. | FINANCIAL STATEMENTS | 3 | |||
Consolidated Balance Sheets | 3 | ||||
Consolidated Statements of Operations | 4 | ||||
Consolidated Statements of Comprehensive Loss | 5 | ||||
Consolidated Statements of Cash Flows | 6 | ||||
Notes to Unaudited Interim Consolidated Financial Statements | 7 | ||||
ITEM 2. | MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS. | 13 | |||
ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK. | 18 | |||
ITEM 4. | CONTROLS AND PROCEDURES. | 18 | |||
PART II - OTHER INFORMATION |
|||||
ITEM 1. | LEGAL PROCEEDINGS. | 18 | |||
ITEM 1A. | RISK FACTORS. | 19 | |||
ITEM 2. | UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS. | 19 | |||
ITEM 3. | DEFAULT UPON SENIOR SECURITIES. | 19 | |||
ITEM 4. | MINE SAFETY DISCLOSURE. | 19 | |||
ITEM 5. | OTHER INFORMATION. | 19 | |||
ITEM 6. | EXHIBITS. | 19 |
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS Back to Table of Contents
OWC Pharmaceutical Research Corp. | ||||
Consolidated Balance Sheets | ||||
At September 30, 2015 and December 31, 2014 | ||||
Back to Table of Contents | ||||
September 30, 2015 | ||||
(Unaudited) | December 31, 2014 | |||
ASSETS | ||||
Current assets: | ||||
Cash | $ | 531,821 | $ | 1,469,267 |
Receivables and other current assets | 10,744 | - | ||
Prepaid expenses | - | 24,091 | ||
Total current assets | 542,565 | 1,493,358 | ||
Property and equipment, net | 25,673 | 29,454 | ||
Total Assets | $ | 568,238 | $ | 1,522,812 |
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||
Current liabilities: | ||||
Accounts payable - trade | $ | 44,542 | $ | 16,523 |
Accrued expenses | 2,950 | 43,643 | ||
Advances and accounts payable to related parties | - | 138 | ||
Total current liabilities | 47,492 | 60,304 | ||
Total liabilities | 47,492 | 60,304 | ||
Stockholders' equity: | ||||
Preferred stock, $0.00001 par value; 20,000,000 shares authorized; no shares issued and outstanding | - | - | ||
Common stock, $0.00001 par value; 500,000,000 shares authorized; and | ||||
81,377,541 and 78,429,241 issued and outstanding at Sept. 30, 2015 and Dec. 31, 2014, respectively | 814 | 784 | ||
Additional paid in capital | 8,486,026 | 8,000,847 | ||
Common stock subscriptions receivable | (651,730) | (651,730) | ||
Accumulated deficit | (7,316,134) | (5,893,878) | ||
Accumulated other comprehensive income | 1,770 | 6,485 | ||
Total stockholders' equity | 520,746 | 1,462,508 | ||
Total liabilities and stockholders' equity | $ | 568,238 | $ | 1,522,812 |
See notes to unaudited interim consolidated financial statements. |
OWC Pharmaceutical Research Corp. | ||||||||
Consolidated Statements of Operations | ||||||||
For the Three and Nine-Month Periods Ended September 30, 2015 and 2014 | ||||||||
(Unaudited) | ||||||||
Back to Table of Contents | ||||||||
For the three |
For the three | For the nine | For the nine | |||||
Months ended | Months ended | Months ended | Months ended | |||||
September 30, 2015 | September 30, 2014 | September 30, 2015 | September 30, 2014 | |||||
Revenues |
$ |
- |
$ |
- |
$ |
- |
$ |
- |
Expenses | ||||||||
General and administrative | 311,391 |
4,353,771 |
1,135,481 |
4,718,983 |
||||
Research and development | 96,834 |
- |
286,774 |
- |
||||
(Loss) from operations | (408,225) | (4,353,771) | (1,422,255) | (4,718,983) | ||||
Other income (expense) | ||||||||
Loss on foreign currency transactions | - | - | - | - | ||||
Interest income (expense) | - | - | - | (2,923) | ||||
Amortization of debt discount | - | - | - | (34,034) | ||||
Total other income (expense) | - |
- |
- | (36,957) |
||||
Total costs and expenses | (408,225) | (4,353,771) | (1,422,255) | (4,755,940) | ||||
Net loss before income taxes | (408,225) | (4,353,771) | (1,422,255) | (4,755,940) | ||||
Income tax | - |
- |
- |
- |
||||
Net loss | $ |
(408,225) | $ |
(4,353,771) |
$ |
(1,422,255) | $ |
(4,755,940) |
Basic and diluted per share amounts: | ||||||||
Basic and diluted net loss | $ |
(0.00) |
$ |
(0.07) |
$ |
(0.02) |
$ | (0.10) |
Weighted average shares outstanding | ||||||||
(basic and diluted) | 81,219,430 |
59,156,164 |
$ |
80,308,561 |
$ | 45,502,721 |
||
See notes to unaudited interim consolidated financial statements. |
OWC Pharmaceutical Research Corp. | ||||||||
Consolidated Statements Comprehensive Loss | ||||||||
For the Three and Nine Months Ended September 30, 2015 and 2014 | ||||||||
(Unaudited) | ||||||||
Back to Table of Contents | ||||||||
For the three | For the three | For the nine | For the nine | |||||
months ended | months ended | months ended | months ended | |||||
September 30, 2015 | September 30, 2014 | September 30, 2015 | September 30, 2014 | |||||
Net loss | $ | (408,225) | $ | (4,353,771) | $ | (1,422,255) | $ | (4,755,940) |
Other comprehensive income (loss), net of tax: | ||||||||
Foreign currency translation adjustments | 893 | - | (4,715) | - | ||||
Total other comprehensive income (loss), net of tax | 893 | - | (4,715) | - | ||||
Comprehensive loss | $ | (407,332) | $ | (4,353,771) | $ | (1,426,970) | $ | (4,755,940) |
See notes to unaudited interim consolidated financial statements. |
OWC Pharmaceutical Research Corp. | ||||
For the Nine-Month Periods Ended September 30, 2015 and 2014 |
||||
(Unaudited) |
||||
For the Nine | For the Nine | |||
Months ended | Months ended | |||
September 30, 2015 | September 30, 2014 | |||
Cash flows from operating activities: | ||||
Net loss | $ |
(1,422,255) |
$ |
(4,755,940) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Contributed capital | - | (6,766) | ||
Amortization of debt discount | - | 34,034 | ||
Depreciation | 6,960 | 788 | ||
Common stock issued for services | 360,369 | 513,000 | ||
Fair value of warrants issued for services | 10,839 | 3,857,135 | ||
Changes in net assets and liabilities: | ||||
(Increase) decrease in accounts receivable | 13,346 | - | ||
(Increase) decrease in prepaid expenses | - | (21,966) | ||
Increase (decrease) accounts payable - related party | (138) | - | ||
Increase (decrease) in accounts payable | 28,020 | 12,158 | ||
Increase (decrease) in accrued expenses | (40,693) |
38,920 |
||
Cash used in operating activities | (1,043,552) |
(328,637) |
||
Cash flow from investing activities: | ||||
Purchase of equipment | (3,179) | (26,463) | ||
Cash used in investing activities | (3,179) |
(26,463) |
||
Cash flow from financing activities: | ||||
Proceeds from issuance of common stock | 114,000 | 1,741,999 | ||
Proceeds of debt borrowings | - | 14,500 | ||
Principal payments | - | (14,500) | ||
Cash provided by financing activities | 114,000 |
1,741,999 |
||
Foreign currency translation | (4,715) |
- |
||
Change in cash | (937,446) |
1,386,899 |
||
Cash - beginning of period | 1,469,267 |
2,469 |
||
Cash - end of period | $ |
531,821 |
$ |
1,389,368 |
Supplement cash flow information: | ||||
Debt and accrued interest converted to equity | $ | - | $ | 132,642 |
OWC Pharmaceutical Research Corp. 1. The Company and Significant Accounting Policies 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. The Company is engaged in
two distinct business activities: (i) work with GUMI to commercialize and
market the Company's Electromagnetic Percussion Device (the "Device"); and
(ii) research and development of Cannabis-based medical products for the
treatment of a variety of medical conditions and/or diseases such as
multiple myeloma, psoriasis, PTSD, migraines and a unique delivery system. The accompanying financial statements of OWCP were prepared from the
accounts of the Company under the accrual basis of accounting. Certain
amounts in the financial statements have been reclassified to conform to the
current presentation. The reclassifications had no effect on the reported
net loss. Basis of Presentation: The accompanying financial statements
have been prepared in conformity with accounting principles generally
accepted in the United States of America, which contemplate continuation of
the Company as a going concern. The Company has not established any source
of revenue to cover its operating costs, and as such, has incurred an
operating loss since inception. These and other factors 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. Principles of Consolidation: The financial statements include
the accounts of OWC Pharmaceutical Research Corp. and its wholly owned
subsidiary One World Cannabis, Inc. (OWC). All significant inter-company
balances and transactions have been eliminated. Significant Accounting Policies Use of Estimates: 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 statement and the reported amounts of revenues and expenses
during the reporting period. Actual results could differ from the estimates. Cash and Cash Equivalents: For financial statement presentation
purposes, the Company considers those short-term, highly liquid investments
with original maturities of three months or less to be cash or cash
equivalents. There were no cash equivalents at September 30, 2015 and
December 31, 2014. Property and Equipment: New property and equipment are recorded
at cost. Property and equipment included in the bankruptcy proceedings and
transferred to the Trustee had been valued at liquidation value.
Depreciation is computed using the straight-line method over the estimated
useful lives of the assets, generally 5 years. Expenditures for renewals and
betterments are capitalized. Expenditures for minor items, repairs and
maintenance are charged to operations as incurred. Gain or loss upon sale or
retirement due to obsolescence is reflected in the operating results in the
period the event takes place. Valuation of Long-Lived Assets: We review the recoverability of
our long-lived assets including equipment, goodwill and other intangible
assets, when events or changes in circumstances occur that indicate that the
carrying value of the asset may not be recoverable. The assessment of
possible impairment is based on our ability to recover the carrying value of
the asset from the expected future pre-tax cash flows (undiscounted and
without interest charges) of the related operations. If these cash flows are
less than the carrying value of such asset, an impairment loss is recognized
for the difference between estimated fair value and carrying value. Our
primary measure of fair value is based on discounted cash flows. The
measurement of impairment requires management to make estimates of these
cash flows related to long-lived assets, as well as other fair value
determinations. Foreign Currency: Non-U.S. entity operations are recorded in the
functional currency of each entity. Results of operations for non-U.S.
dollar functional currency entities are translated into U.S. dollars using
average currency rates. Assets and liabilities are translated using currency
rates at period end. Foreign currency translation adjustments are recorded
as a component of other comprehensive income (loss) within stockholders'
equity. Stock Based Compensation: Stock-based awards are accounted for
using the fair value method in accordance with ASC 718, Share-Based
Payments. Our primary type of share-based compensation consists of stock
options. We use the Black-Scholes option pricing model in valuing options.
The inputs for the valuation analysis of the options include the market
value of the Company's common stock, the estimated volatility of the
Company's common stock, the exercise price of the warrants and the risk free
interest rate. Accounting For Obligations And Instruments Potentially To Be Settled
In The Company's Own Stock: We account for obligations and
instruments potentially to be settled in the Company's stock in accordance
with FASB ASC 815, Accounting for Derivative Financial Instruments. This
issue addresses the initial balance sheet classification and measurement of
contracts that are indexed to, and potentially settled in, the Company's own
stock. Fair Value of Financial Instruments: FASB ASC 825, "Financial
Instruments," requires entities to disclose the fair value of financial
instruments, both assets and liabilities recognized and not recognized on
the balance sheet, for which it is practicable to estimate fair value. FASB
ASC 825 defines fair value of a financial instrument as the amount at which
the instrument could be exchanged in a current transaction between willing
parties. At September 30, 2015 and December 31, 2014, the carrying value of
certain financial instruments (cash and cash equivalents, accounts payable
and accrued expenses.) approximates fair value due to the short-term nature
of the instruments or interest rates, which are comparable with current
rates. Fair Value Measurements: The Company measures fair value under
a framework that utilizes a fair value hierarchy that prioritizes the inputs
to valuation techniques used to measure fair value. The hierarchy gives the
highest priority to unadjusted quoted prices in active markets for identical
assets or liabilities (level 1 measurements) and the lowest priority to
unobservable inputs (level 3 measurements). The three levels of inputs which
prioritize the inputs used in measuring fair value are: Level 1: Inputs to the valuation methodology are unadjusted quoted
prices for identical assets or liabilities in active markets that the
Company has the ability to access. The assets or liability's fair value measurement level within the fair
value hierarchy is based on the lowest level of any input that is
significant to the fair value measurement. Valuation techniques used need to
maximize the use of observable inputs and minimize the use of unobservable
inputs. The following table presents assets that were measured and recognize
at fair value on September 30, 2015 and December 31, 2014 and the year then
ended on a recurring basis: Fair Value Measurements at September 30, 2015 Quoted Prices in Active Significant Other Significant Markets for Identical Assets Observable Inputs Unobservable Inputs Total (Level 1) (Level 2) (Level 3) $ - $ $ - $ - $ - $ $ - $ - Fair Value Measurements at December 31, 2014 Quoted Prices
in Active Significant
Other Significant Markets for
Identical Assets Observable
Inputs Unobservable
Inputs Total (Level 1) (Level 2) (Level 3) $ - $ $ - $ - $ - $ $ - $ - When the Company changes its valuation inputs for measuring financial
assets and liabilities at fair value, either due to changes in current
market conditions or other factors, it may need to transfer those assets or
liabilities to another level in the hierarchy based on the new inputs used.
The Company recognizes these transfers at the end of the reporting period
that the transfers occur. For the fiscal periods ended September 30, 2015
and December 31, 2014, there were no significant transfers of financial
assets or financial liabilities between the hierarchy levels. Earnings per Common Share: We compute net income (loss) per
share in accordance with ASC 260, Earning per Share. ASC 260 requires
presentation of both basic and diluted earnings per share (EPS) on the face
of the income statement. Basic EPS is computed by dividing net income (loss)
available to common shareholders (numerator) by the weighted average number
of shares outstanding (denominator) during the period. Diluted EPS gives
effect to all dilutive potential common shares outstanding during the period
using the treasury stock method and convertible preferred stock using the
if-converted method. In computing Diluted EPS, the average stock price for
the period is used in determining the number of shares assumed to be
purchased from the exercise of stock options or warrants. Diluted EPS
excludes all dilutive potential shares if their effect is anti-dilutive. Income Taxes: We have adopted ASC 740, Accounting for Income
Taxes. Pursuant to ASC 740, we are required to compute tax asset benefits
for net operating losses carried forward. The potential benefits of net
operating losses have not been recognized in these financial statements
because the Company cannot be assured it is more likely than not it will
utilize the net operating losses carried forward in future years. We must make certain estimates and judgments in determining income tax
expense for financial statement purposes. These estimates and judgments
occur in the calculation of certain tax assets and liabilities, which arise
from differences in the timing of recognition of revenue and expense for tax
and financial statement purposes. Deferred tax assets and liabilities are determined based on the
differences between financial reporting and the tax basis of assets and
liabilities using the tax rates and laws in effect when the differences are
expected to reverse. ASC 740 provides for the recognition of deferred tax
assets if realization of such assets is more likely than not to occur.
Realization of our net deferred tax assets is dependent upon our generating
sufficient taxable income in future years in appropriate tax jurisdictions
to realize benefit from the reversal of temporary differences and from net
operating loss, or NOL, carryforwards. We have determined it more likely
than not that these timing differences will not materialize and have
provided a valuation allowance against substantially all of our net deferred
tax asset. Management will continue to evaluate the realizability of the deferred
tax asset and its related valuation allowance. If our assessment of the
deferred tax assets or the corresponding valuation allowance were to change,
we would record the related adjustment to income during the period in which
we make the determination. Our tax rate may also vary based on our results
and the mix of income or loss in domestic and foreign tax jurisdictions in
which we operate. In addition, the calculation of our tax liabilities involves dealing with
uncertainties in the application of complex tax regulations. We recognize
liabilities for anticipated tax audit issues in the U.S. and other tax
jurisdictions based on our estimate of whether, and to the extent to which,
additional taxes will be due. If we ultimately determine that payment of
these amounts is unnecessary, we will reverse the liability and recognize a
tax benefit during the period in which we determine that the liability is no
longer necessary. We will record an additional charge in our provision for
taxes in the period in which we determine that the recorded tax liability is
less than we expect the ultimate assessment to be. ASC 740 which requires recognition of estimated income taxes payable or
refundable on income tax returns for the current year and for the estimated
future tax effect attributable to temporary differences and carry-forwards.
Measurement of deferred income tax is based on enacted tax laws including
tax rates, with the measurement of deferred income tax assets being reduced
by available tax benefits not expected to be realized. Uncertain Tax Positions: When tax returns are filed, it is
highly certain that some positions taken would be sustained upon examination
by the taxing authorities, while others are subject to uncertainty about the
merits of the position taken or the amount of the position that would be
ultimately sustained. In accordance with the guidance of FASB ASC 740-10,
Accounting for Uncertain Income Tax Positions, the benefit of a tax position
is recognized in the financial statements in the period during which, based
on all available evidence, management believes it is more likely than not
that the position will be sustained upon examination, including the
resolution of appeals or litigation processes, if any. Tax positions taken
are not offset or aggregated with other positions. Tax positions that meet
the more-likely-than-not recognition threshold are measured as the largest
amount of tax benefit that is more than 50 percent likely of being realized
upon settlement with the applicable taxing authority. The portion of the
benefits associated with tax positions taken that exceeds the amount
measured as described above should be reflected as a liability for
unrecognized tax benefits in the accompanying consolidated balance sheets
along with any associated interest and penalties that would be payable to
the taxing authorities upon examination. Our federal and state income tax returns are open for fiscal years ending
on or after December 31, 2010. We are not under examination by any
jurisdiction for any tax year. At September 30, 2015 we had no material
unrecognized tax benefits and no adjustments to liabilities or operations
were required under FASB ASC 740-10. Recent Accounting Pronouncements In April 2015, the Financial Accounting Standards Board ("FASB") issued
Accounting Standards Update ("ASU") 2015-03, "Interest-Imputation of
Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance
Costs." ASU 2015-03 requires that debt issuance costs related to a
recognized debt liability be presented in the balance sheet as a direct
deduction from the carrying amount of that debt liability, consistent with
debt discounts. Currently, debt issuance costs are recognized as deferred
charges and recorded as other assets. The guidance is effective for annual
and interim periods beginning after December 15, 2015 with early adoption
permitted and is to be implemented retrospectively. Adoption of the new
guidance will only affect the presentation of the Company's consolidated
balance sheets and will have no impact to our financial statements. Management does not anticipate that the adoption of these standards will
have a material impact on the financial statements. The Financial Statements presented herein have been prepared by us in
accordance with the accounting policies described in our December 31, 2014
Annual Report and should be read in conjunction with the Notes to Financial
Statements which appear in that report. The preparation of these financial statements in conformity with
accounting principles generally accepted in the United States requires us to
make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses, and related disclosure of contingent
assets and liabilities. On an on-going basis, we evaluate our estimates,
including those related intangible assets, income taxes, insurance
obligations and contingencies and litigation. We base our estimates on
historical experience and on various other assumptions that are believed to
be reasonable under the circumstances, the results of which form the basis
for making judgments about the carrying values of assets and liabilities
that are not readily apparent from other resources. Actual results may
differ from these estimates under different assumptions or conditions. In the opinion of management, the information furnished in these interim
financial statements reflects all adjustments necessary for a fair statement
of the financial position and results of operations and cash flows as of and
for the three and nine-month periods ended September 30, 2015 and 2014. All
such adjustments are of a normal recurring nature. The Financial Statements
do not include some information and notes necessary to conform to annual
reporting requirements. 2. Stockholders' Equity Common Stock Stock Issued for Cash in 2015: In August of 2015, we also received $24,000 through a placement of
100,000 common stock units. Those units were sold at $0.24 per unit. Each
unit consisted of two shares of common stock and two warrants to purchase
common stock, which warrants are exercisable at $0.12 and $0.25 and expire on August
31, 2016 and
expire on August 31, 2017, respectively. In connection with a private placement of 10,000,000 shares of common
stock in February of 2015 we sold 800,000 shares to one investor for the
offering price of $0.05 per share that resulted in total proceeds of
$40,000. During 2015, we also received $50,000 through a placement of common
stock units. Those units were sold at $0.15 per unit. Each unit consisted of
one share of common stock and one warrant to purchase common stock. The
related warrants are exercisable at $0.25 and expire on December 31, 2016. Stock Issued for Services in 2015: During the interim period ended September 30, 2015 we issued 1,614,935
shares of our common stock to unrelated parties as payment for services. The
shares were valued at the closing price as of the date of the agreements
(ranging from $0.19 to $0.25) and resulted in full recognition of $360,369
in consulting services expense. During
the period ended June 30, 2015, the Company cancelled 500,000 shares of
common stock previously issued for services. Historical Activity in 2014: Stock Issued Upon Conversion of Debt in 2014: On July 1, 2014 we issued 179,300
shares of our common stock in settlement of $1,500 in convertible note
payable plus associated accrued interest of $293. The conversion occurred
within the terms of the promissory note and no gain or loss resulted. On
February 28, 2014 we issued 13,084,000 shares of our common stock in
settlement of $114,414 in convertible note payable plus associated accrued
interest of $16,435. The conversion occurred within the terms of the
promissory note and no gain or loss resulted. Stock Issued for Cash in 2014: In connection with a private placement of 10,000,000 shares of common
stock in March and April of 2014 we sold 4,700,000 shares to six investors
for the offering price of $0.005 per share that resulted in total proceeds
of $23,500. During 2014 we received $1,164,300 through a placement of common
stock units. Those units were sold at $0.09 per unit. Each unit consisted of
one share of common stock and one warrant to purchase common stock. We
issued 12,936,662 shares through September 30th to 22 investors of this
offering. The warrants are exercisable at $0.16 and expired in June, 2015.
During 2014 we received $554,200 through a placement of common stock units.
Those units were sold at $0.15 per unit. Each unit consisted of one share of
common stock and one warrant to purchase common stock. We issued 3,694,666
shares through September 30th to 4 investors of this offering. The warrants
are exercisable at $0.16 and expired in June 2015. Stock Issued for Services in 2014: During the interim period ended September 30, 2014 we issued 300,000
shares of our common stock to an unrelated party as payment for services. We
also issued 400,000 shares to two former officers and directors of the
company as part of a severance agreement. The shares were valued at the
closing price as of the date of the agreements ($0.25 and $0.28,
respectively) and resulted in full recognition of $187,000 in consulting
services expense. During the interim periods ended on or before June 30,
2014 we issued 9,208,600 shares of our common stock to seven unrelated
parties as payment for services. The shares were valued at the closing price
as of the date of the agreement ($0.05) and resulted in full recognition of
$481,430 in consulting services expense. In June we cancelled 3,108,600 of
these shares valued at $155,430 resulting in $305,000 in consulting expense
through September 30, 2014. Options Issued for Services in 2014: During the interim period ended September 30, 2014 we issued 14,350,000
common stock options. 350,000 of those options valued at $82,640 were
granted to former related parties while 14,000,000 options valued at
$3,774,496 were granted for services provided by unrelated parties. The fair value of the options was estimated at the date of grant using
the Black-Sholes-Merton pricing model. The Black-Sholes-Merton pricing model
assumptions used are as follows: expected dividend yield of 0%; risk-free
interest rate of 0.47% to 0.49%; expected volatility of 241%, and warrant
term of two years. Warrants As part of the 2015 unit offerings the Company issued a total of 533,333
warrants to purchase up to 533,333 shares of common stock ranging from $0.12
to $0.25 per share. The relative fair value of the warrants attached to the common stock
issued was estimated at the date of grant using the Black-Sholes-Merton
pricing model. The relative fair value of the attached to the common stock
component is $39,711 and the relative fair value of the warrants is $34,289
as of the grant date. In February, 2015 we issued 64,935 warrants for services. The warrants
are exercisable at $0.25 and expire February 23, 2016. We used the
Black-Scholes-Merton pricing model and inputs described below to estimate
the fair value of $10,839. 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 242%, and warrant exercise period based upon the
stated terms. 3. Related Party Transactions Not Disclosed Elsewhere Due Related Parties: Amounts due related parties totaled $0 at September
30, 2015 and $138 at December 31, 2014, respectively. Accounts receivable
from related parties was $0 at September 30, 2015 and $0 at December 31,
2014. 4. Receivables and Other Current Assets As of September 30, 2015, the Company recorded $10,744 in receivables and
other current assets. This amount represents value added tax ("VAT") paid in
connection with certain expenses we incurred and is reimbursed by Israeli
Tax Authority every two months. 5. Notes Payable Unsecured Notes Payable Without Conversion Rights During 2014, the Company signed a series of three new unsecured
promissory notes with unrelated parties for an aggregate of $14,500. The
notes bear interest at 1% per annum and are due one year from the date of
issuance. The notes were paid in full in 2014. Unsecured Notes Payable With Conversion Rights On February 28, 2014 eleven holders of convertible notes with an
aggregate principal balance of $114,414 and accrued interest of $16,435
converted their notes and accrued interest into 13,084,000 shares of common
stock. Upon conversion, $34,034 of unamortized discount arising from the
previously recorded beneficial conversion feature was recognized as
additional interest expense. The conversion occurred within the terms of the
promissory note and no gain or loss resulted. 6. Future Commitment and Issuance of Warrants On March 5, 2013, the Company and GUMI Tel Aviv Ltd, a major,
privately-held Israeli technology company ("GUMI"), entered into
development/manufacturing/marketing agreement ("GUMI Agreement"). GUMI is
engaged in the manufacture, import/export, marketing and install industrial
equipment and designing technical solutions. Pursuant to the GUMI Agreement, GUMI agreed to: (i) complete the
development of the Prototype of the Patented Device; (ii) manufacture the
commercial model(s) of the Patented device; and (iii) market the commercial
model(s) of the Patented Device. In consideration for developing the Prototype and manufacturing and
marketing/distributing commercial models of the Patented Device as well as
incurring all related costs and expenses in connection therewith, the
Company shall compensate GUMI as follows: (i) upon the execution of the GUMI
Agreement, the Company granted GUMI warrants (the "Warrants") exercisable to
purchase 200,000 shares of the Company's common stock ("Warrant Shares") at
an exercise price of USD$0.05 per share (the "Exercise Price"); (ii) upon
completion of the Prototype, granting GUMI additional Warrants to purchase
200,000 additional Warrant Shares at the Exercise Price; and (iii) upon
completion of a Commercial Device ready for manufacture and sale, granting
GUMI additional Warrants to purchase 200,000 additional Warrant Shares at
the Exercise Price. The Warrants shall expire 3 years from the date of each
grant and shall be subject to adjustment in the event of any
recapitalization of the Company's capital stock. In addition to the consideration represented by the grant of Warrants,
the Agreement further provides that following commencement of sale of the
Commercial Device and until such time that GUMI has recouped all costs and
expenses that it has incurred and paid in connection with the completion of
development of the Prototype and the manufacture of the Commercial Device
("Date of Recoupment"), one hundred (100%) percent of the net sales revenues
shall be paid and distributed to GUMI. On and after the Date of Recoupment,
net sales revenues shall be paid sixty-five (65%) percent to GUMI and
thirty-five (35%) percent to the Company. The Company recorded $107,074 in fiscal year 2013 in expenses related to
600,000 vested warrants previously granted to GUMI Tel Aviv Ltd. The
warrants were valued using the Black-Scholes option pricing model. The
inputs for the valuation analysis of the warrants include the market value
of the Company's common stock were as follows: the estimated volatility of
the Company's common stock used in the Black-Scholes option pricing model
was 318%, the exercise price and the risk free interest rate used were $0.05
and 0.36%, respectively. All warrants are fully vested. 7. Going Concern The accompanying financial statements have been prepared in conformity
with accounting principles generally accepted in the United States of
America, which contemplate continuation of the Company as a going concern.
The Company has not established any source of revenue to cover its operating
costs, and as such, has incurred an operating loss since inception. Further,
as of September 30, 2015, the cash resources of the Company were
insufficient to meet its current business plan. These and other factors
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 asset or the amounts and classification of liabilities
that may result from the possible inability of the Company to continue as a
going concern. 8. Subsequent Events There were no subsequent events following the period ended September 30,
2015 and throughout the date of the filing of Form 10-Q.
ITEM
2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS 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. They 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 three distinct business sectors and we may require
additional capital to implement our business plan and fund our operations. Our three distinct business operations are: (i) continuing to work with GUMI
to commercialize and market the Company's Electromagnetic Percussion Device (the
"Device"); and We have not yet commenced any significant activities related to our
medical cannabis-related consulting services. In 2008, we acquired the patent for our Device and from 2008 until 2011, we
devoted our limited resources and efforts to the development of our Device.
During late 2011 and into 2012, we renewed our interest in pursuing development
of our Device and, subsequent to our year ended December 31, 2012, we entered
into an agreement with GUMI to develop a Device prototype, which was
successfully completed. GUMI has completed the manufacture of several commercial
models of the Device that GUMI is presently devoting resources to market under
the terms of our agreement. We continue to be dependent upon the ability of GUMI
to successfully market our Device, which process has started. However, we have
not yet derived any revenues from GUMI's on-going marketing efforts, which
commenced in late 2013 and are continuing in 2015. We raised approximately 1,7420,000 during
the nine-month period ended September 30, 2015 and have used and will
continue to utilize the capital we raised to fund OWC's business, including
the assembly of a professional team of highly-qualified medical and
scientific experts together with experienced management and marketing
executives to develop OWC's business. 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 yet been
scientifically researched and demonstrated. 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 active compounds from the cannabis plant, that
must be fully researched and documented in order to verify its effectiveness to
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 researches, 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. Baruch, OWC's Director of Research and Regulatory Affairs, and Alon Sinai,
OWC's Chief Operating Officer, will monitor the investigations and researches. To date, OWC has signed three research collaboration and license agreements
with Sheba Academic Medical Center, Tel Hashomer, Israel ("Sheba"). 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 agreements with Sheba, OWC will initiate three studies at the
Sheba facilities to explore the effect of three formulations, all based on
active ingredients in the cannabis extracts, on multiple myeloma, psoriasis and
fibromyalgia (a specific formulation to each indication). At present, OWC is negotiating with two other Israeli leading medical centers
for the collaboration in the research of migraine and PTSD (post-traumatic
stress disorder). The Company expects these agreements to be finalized during
the fourth quarter of 2015. Of course, there can be no assurance that we be able
to successfully negotiate these agreements before the end of 2015, if at all. In addition, OWC signed an R&D service agreement with G.C. Group Ltd. - an
Israeli pharmaceutical R&D company, to provide formulation development services
for OWC's new delivery system in the form of a cannabis dissoluble tablet. The
cannabis dissoluble tablet could provide physicians with the ability to control
and administrate optimal dosage, to replace the most common usage/delivery
method of medical cannabis today, which is not acceptable by scientists and
physicians, such as smoking, edibles and oil extracts with no adequate means of
dosage control. The Company expects to start developing other delivery system, designed for
different indications, during the fourth quarter of 2015. The Company has recently signed a Memorandum of Understanding (MoU) with
Emilia Cosmetics Ltd. - a large Israeli private label manufacturer, for the
developing, manufacturing and marketing of a cannabinoid-based topical cream to
treat psoriasis. The Company will initiate the research and development of the
topical cream by the end of the third quarter of 2015, at Emilia Cosmetics labs
located in Yerucham, Israel. After the completion of the formulation
development, during the fourth quarter of 2015, the Company will initiate a
phase I study at the Sheba facilities to explore the effect of topical cream on
psoriasis. However, we do not know if our expectations will be fulfilled in a
timely manner, if at all, or that the costs of development will exceed our
anticipation. To date, One World Cannabis has filed eight provisional 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 and fibromyalgia
agreements with Sheba provide that all intellectual property rights that is
conceived during the course of the research is to be jointly owned by Sheba and
One World Cannabis Intellectual rights related to the multiple myeloma are being
negotiated and the Company expects to finalized an agreement during the 4th
quarter of 2015. Pursuant to the collaboration agreements, we are obliged to pay Sheba
$330,000 for conducting the multiple myeloma trial between the 3rd quarter of
2015 and the second quarter of 2016. In addition, we expect to commence
pre-clinical studies on fibromyalgia and psoriasis during 3rd quarter of 2015.
Pursuant to the collaboration agreements, we are obliged to pay Sheba $300,000
during the 1st quarter of 2016 for conducting the psoriasis research, and
$100,000 for the fibromyalgia research during the two years of the study. As of
September 30, 2015, we have a balance of approximately $110,000 due in
connection with the Sheba agreements. We
currently have the financial resources to fund these studies, but anticipate
that we will require additional funding during the next 12 months for our
continuing and planned expanded operations. In addition, we signed an R&D service agreement with G.C. Group Ltd. - an
Israeli pharmaceutical R&D company, to provide formulation development services
for OWC's new delivery system in the form of a cannabis soluble tablet. The
cannabis soluble tablet could provide physicians with the ability to control
and administrate optimal dosage, to replace the most common usage/delivery
method of medical cannabis today, which is not acceptable by scientists and
physicians, such as smoking, edibles and oil extracts with no adequate means of
dosage control.
Pursuant to the R&D service agreements, we are obliged to pay G.C. Group
Ltd. $220,000. On October 11, 2015 and October 27, 2015, respectively, the Company
entered into Memorandums of Understanding ("MOUs") with Medmar LLC,
organized under the laws of the State of Maryland ("Medmar") and Medmar II,
LLC, organized under the laws of the States of Hawaii and Pennsylvania ("Medmar
II"), respectively. Medmar and Medmar II were organized for, among other
purposes, securing licenses in their respective jurisdictions for growing,
extracting and dispensing medical cannabis products under their applicable
state laws that were recently enacted. Pursuant to the MOUs, which are substantially identical, the Company will
provide Medmar and Medmar II consulting services in Maryland, on the one
hand, and Hawaii and Pennsylvania, on the other hand, based on the existing
knowledge and regulatory expertise of the Company's wholly-owned Israeli
subsidiary, One World Cannabis Ltd ("OWC ") in the field of medical cannabis
treatment, in patient care programs, and in establishing training and
consulting centers for medical staff and patients, and assisting with the
creation and implementation of regulations governing the medical cannabis
program. The MOUs provide for granting licenses to use the intellectual
property of OWC for the manufacture and use of OWC Israel's medical cannabis
prospective products for the treatment of Multiple Myeloma, PTSD,
Fibromyalgia and Acute Migraine. Research and Development Status The following table summarizes the stages of
development for each of our current Prospect Products. OWC'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 in vitro tests results on multiple myeloma cells
studied outside their normal biological context, on which we announced on June
17, 2015, led us to proceed with further pre-clinical study (safety and
toxicity, PK, PD) of our formulation, to find out whether it has scientific
merit for further development as an investigational new drug. While 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; Any of the foregoing could have a material adverse
effect on our business, results of operations and financial condition. Consulting Services OWC 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 does
not allow for comprehensive 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 Prospect Product
development. However, there can be no assurance that this strategy will be
successful in generating any revenues or growing out business. Results of Operations during the three months ended September 30, 2015 as compared to the
three months ended September 30, 2014 We have not generated any revenue during the three months ended September 30,
2015 and 2014. We have operating expenses related to general and administrative
expenses and research and development expenses. During the three months ended
September 30, 2015, we incurred a net loss of $408,225 due to general and
administrative expenses of $311,391 and research and development expenses of
$96,834 as compared to a net loss of $4,353,771 in the same period in the prior
year, which net loss was principally due to a non-cash
compensation expense of $4,044,135 related to the issuance of shares and
warrants for services. Our general and administrative expenses decreased
by $4,042,380 during the three-month period ended September 30, 2015 as
compared to the same period in the prior year due to a significant decrease in
non-cash compensation expense. During the three-month period
ended September 30, 2015, we incurred $292,598 in research and development expenses as
compared to no such expenses in the same period in the prior year. Our comprehensive net loss during the three months ended
September 30, 2015 was
$407,332, due to
a net loss of $408,225 and $893 in
foreign currency translation adjustments as
compared to
no foreign currency translation
adjustments in the same period in the prior year. Results of Operations during the
nine months ended September 30, 2015 as compared to the
nine months ended September 30, 2014 We have not generated any revenue during the nine months ended September
30,
2015 and 2014. We had operating expenses related to general and administrative
expenses and research and development expenses. During the nine months ended
September
30, 2015, we incurred a net loss of $1,422,255 due to general and
administrative expenses of $1,135,481 and research and development expenses of
$286,774 as compared to a net loss of $4,755,940 due to general and
administrative expenses of $4,718,983 including 4,370,135 non-cash compensation
expense, interest expenses of $2,923 and
expenses related to amortization of debt discount of $34,034. Our general and administrative expenses decreased
by $3,583,502 or 76% during the nine-month period ended September 30, 2015 as
compared to the same period in the prior year. During the nine-month period
ended September 30, 2015, we incurred $286,774 in research and development expenses
as compared to no such expenses in the same period in the prior year. Our comprehensive net loss during the
nine months ended September 30, 2015 was
$1,426,970, due to a net loss of $1,422,255 and $4,715 in foreign currency translation adjustments as
compared to
no foreign currency translation
adjustments in the same period in the prior year. Liquidity and Capital Resources On September 30, 2015, we had current
assets of $542,565 consisting of $531,821 in cash, receivables and other current
assets of
$10,744.
We had property and equipment valued at
$25,673 as of September 30, 2015. We had total assets of $568,238
as of September 30, 2015. We had total assets of $1,522,812 as
of December 31, 2014, consisting of $1,469,267 in cash, $24,091 in other
current assets and equipment valued at $29,454.
On September 30, 2015, we had $47,492 in current liabilities consisting of $44,542 in
accounts payable and $2,950 in accrued expenses. On December 31, 2014, we had
total liabilities of $60,304 consisting of $16,523 in accounts payable, $43,643
in accrued expenses and $138 in advances and accounts payable to related
parties. We had positive working capital of $495,073 at September 30, 2015 and
$1,433,054 at December 31, 2014. Our accumulated deficits as of September 30, 2015
and December 31, 2014 were $7,316,134 and $5,893,878, respectively. We used $1,043,552 in our operating activities during the nine months ended
September 30, 2015, which was due to a net loss of $1,422,255 offset by depreciation
expenses of $6,960, shares issued for services valued at $360,369, warrants issued
for services valued at $10,839, a decrease in accounts receivable of $13,346, a decrease in accounts payable to a
related party of $138, an increase
in accounts payable of $28,020 and an increase in accrued expenses of $40,693. We used $328,637 in our operating activities during the nine months ended
September
30,
2014, which was due to a net loss of $4,755,940 and capital contribution of
$6,766 offset by amortization
of debt discount expenses of $34,034, depreciation expenses of $788, non-cash compensation expenses
related to warrants and shares valued at $4,370,135, an
increase in prepaid expenses of $21,966, a decrease of $12,158 in accounts payable and
$38,920 in accrued liabilities. We used $3,179 during the nine months ended September 30, 2015 and $26,463
during the same period in the prior year to purchase property and equipment. Our financing activities during the nine months ended September 30, 2015
provided us with $114,000 from the issuance of 1,333,333 shares
of common stock. We financed our negative cash flow from operations during the nine months ended
September 30, 2014 through proceeds from issuance of common stock of $1,741,999
and proceeds of debt borrowings of $14,500 reduced by $14,500 in debt payments. Based upon our cash position of $531,821 at September 30, 2015, we believe that
we may need to raise additional capital, either equity or debt prior to the end
of fiscal 2015 or during the first quarter of fiscal year 2016 in order to fund our plan of operations including our research
and development initiatives for the next twelve months. There can be no
assurance, however, that additional capital will be sufficient to fund our
currently anticipated expenditure requirements for the next twelve-month period
nor can there be any assurance that financing will be available at satisfactory
terms and conditions or at all, for that matter. Our auditors have issued an opinion on our financial statements which
includes a statement describing our going concern status. This means that there
is substantial doubt that we can continue as an on-going business for the next
twelve months unless we obtain additional capital to pay our bills and meet our
other financial obligations. This is because we have not generated any revenues
and no revenues are anticipated until we begin marketing the product.
Accordingly, we must raise capital from sources other than the actual sale of
the product. We must raise capital to implement our project and stay in
business. Even if we raise the maximum amount of money in this offering, we do
not know how long the money will last, however, we do believe it will last at
least twelve months. 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 have 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. Within the framework of this collaboration
agreement, the Company currently conducts pre-clinical studies on multiple
myeloma, which have commenced in April 2015 and we expect to commence
pre-clinical studies on fibromyalgia in the third quarter of 2015. Pursuant to
the agreement, we are obligated to pay Sheba $330,000 between the third quarter
of 2015 and second quarter of 2016. We are obligated to provide $300,000 in funding in the first quarter of 2016
related to the Psoriasis research conducted at Sheba. We have funding
obligations of $100,000 related to the Fibromyalgia research due during two
years of the studies. Our capital expenditures allocated to our corporate activities conducted
through our facilities in Petach Tikva are expected to be around $606,000 during
2015. At present, we use our available working capital to fund these studies.
However, we may need to raise additional funding prior to or if clinical studies
are to commence. Off-Balance Sheet Arrangements As of September 30, 2015 and December 31, 2014, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K promulgated under the Securities Act of 1934. Critical Accounting Policies Our significant accounting policies are described in the notes to our financial statements for the
period ended September 30, 2015, and are included elsewhere in this
quarterly report. ITEM 3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Notes to Unaudited Interim
Consolidated Financial Statements
September 30, 2015
Back to
Table of Contents
Level 2: Inputs to the
valuation methodology include:
- Quoted prices for similar assets or
liabilities in active markets;
- Quoted prices for identical or similar
assets or liabilities in inactive markets;
- Inputs other than quoted
prices that are observable for the asset or liability;
- Inputs that are
derived principally from or corroborated by observable market data by
correlation or other means.
If the asset or liability has a specified
(contractual) term, the level 2 input must be observable for substantially
the full term of the asset or liability.
Level 3: Inputs to the
valuation methodology are unobservable and significant to the fair value
measurement.
None
-
Total
assets at fair value
-
None
-
Total
assets at fair value
-
(ii) 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, among others, and
(iii)
consulting services to companies and governmental agencies with respect to
complex international medical cannabis protocols and regulations.
Targeted Medical Condition
Collaborator
Status
Use of cannabis to treat
multiple Myeloma
Sheba Academic
Medical Center
Basic Science
Research Agreement - signed;
Clinical Research Agreement - in
negotiation;
Pre-clinical study: Approved by Ethics Committee (IRB);
In vitro tests - completed.
Next: Pre-clinical study: Safety and
Toxicity, PK, PD
Clinical trial protocol synopsis - draft completed.
Use of cannabis to treat
Psoriasis
(1) Sheba
Academic Medical Center
Research
Collaboration and License Agreement - signed;
Protocol of 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 - draft completed.
Use of cannabis to treat
Psoriasis
(2)
Emilia Cosmetics Ltd.
Memorandum of
Understanding (MoU) for the developing, manufacturing and marketing of a
cannabinoid-based topical cream to treat psoriasis - signed;
Received
license to purchase and use of cannabis for R&D purposes;
Formulation
development will be initiated during third quarter of 2015.
Use of cannabis to treat
Fibromyalgia
Sheba
Academic Medical Center
Research
Collaboration and License Agreement - signed;
Clinical trial protocol
synopsis - initial draft completed.
New delivery system - cannabis
dissoluble tablet
G.C. Group Ltd.
Formulation
development;
Received license to purchase and use of cannabis for R&D
purposed.
Use of cannabis to treat PTSD
In
Negotiations
Clinical trial
documents - submitted; Awaiting for Ethics Committee (IRB) final
approval.
Use of cannabis to treat Migraine
In
Negotiations
Clinical trial
protocol synopsis - initial draft completed.
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;
None.
ITEM 4. CONTROLS AND PROCEDURES Back to Table of Contents
Evaluation of disclosure controls and procedures. As of September 30, 2015, 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, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures were not effective as of the end of the period covered by this report.
Changes in internal controls. During the quarterly period covered by this report, no changes occurred in our internal control over financial reporting that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS Back to Table of Contents
We are not currently subject to any material legal proceedings, nor, to our knowledge, is any material legal proceeding threatened against us. However, from time to time, we may become a party to certain legal proceedings in the ordinary course of business.
ITEM 1A. RISK FACTORS Back to Table of Contents
In addition to the other information set forth in this report, you should carefully consider the factors discussed in Part I, Item 1. Description of Business, subheading "Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2014, which could materially affect our business, financial condition or future results. The risks described in our Annual Report on Form 10-K are not the only risks facing our company. Additional 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 and/or operating results.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS Back to Table of Contents
During the three-months ended September 30, 2015, the Company issued 533,333 restricted shares of common stock valued at $74,000 in reliance upon the exemptions provided in Section 4(2) of the Securities Act of 1933, as amended (the "Act") and Regulation D and Regulation S promulgated by the United States Securities and Exchange Commission (the "SEC") under the Act.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES Back to Table of Contents
None.
ITEM 4. MINE SAFETY DISCLOSURE. Back to Table of Contents
Not applicable.
ITEM 5. OTHER INFORMATION Back to Table of Contents
Not applicable.
ITEM 6. EXHIBITS Back to Table of Contents
(a) The following documents are filed as exhibits to this report on Form 10-Q or incorporated by reference herein. Any document incorporated by reference is identified by a parenthetical reference to the SEC filing that included such document.
Exhibit No. |
Description |
---|---|
31.1 | Section 302 Certification of the Sarbanes-Oxley Act of 2002 of the Company's CEO, Mordechi Bignitz, filed herewith. |
31.2 | Section 302 Certification of the Sarbanes-Oxley Act of 2002 of the Company's CFO, Shmuel De-Saban, filed herewith. |
32.1 | Section 906 of the Sarbanes-Oxley Act of 2002 of Mordechi Bignitz as CEO, filed herewith |
32.2 | Section 906 of the Sarbanes-Oxley Act of 2002 of Shmuel De-Saban as CFO, filed herewith |
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned.
Signature | Title | Date |
/s/ Mordechai Bignitz | Chief Executive Officer (Principal Executive Officer) | November 13, 2015 |
Mordechai Bignitz | ||
/s/ Shmuel De-Saban | Chief Financial Officer (Principal Financial and Accounting Officer) | November 13, 2015 |
Shmuel De-Saban | ||
Pursuant to the requirements of the Securities Act of 1934, this report has been signed by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature | Title | Date |
/s/ Mordechai Bignitz | Chief Executive Officer | November 13, 2015 |
Mordechai Bignitz | ||
/s/ Mordechai Bignitz | Chairman | November 13, 2015 |
Mordechai Bignitz | ||