UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period endedSeptember 30, 2014
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE EXCHANGE ACT
For the transition period from _________ to ________
Commission File No.000-54394
ONLINE DISRUPTIVE TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
Nevada | 27-1404923 |
(State or other jurisdiction | (I.R.S. Employer |
of incorporation or organization) | Identification No.) |
3120 S. Durango Drive, Suite 305, Las Vegas, Nevada 89117
(Address of principal executive offices) (zip code)
702-579-7900
(Registrant’s telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
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 has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
Yes [X] No [ ]
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer [ ] | Accelerated filer [ ] | |
Non-accelerated filer [ ] | (Do not check if a smaller reporting company) | Smaller reporting company [X] |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes [ ] No [X]
ii
APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS
DURING THE PRECEDING FIVE YEARS
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Securities and Exchange Act of 1933 subsequent to the distribution of securities under a plan confirmed by a court.
Yes [ ] No [ ]
APPLICABLE ONLY TO CORPORATE ISSUERS
State the number of shares outstanding of each of the issuer’s classes of common equity as of the latest practicable date:
As of November 12, 2014, there were 82,636,433 shares of common stock, par value $0.001, outstanding.
iii
TABLE OF CONTENTS
1
PART I - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
2
ONLINE DISRUPTIVE TECHNOLOGIES, INC. |
(A Development Stage Company) |
CONSOLIDATED INTERIM FINANCIAL STATEMENTS |
FOR THE NINE MONTH PERIOD ENDED SEPTEMBER 30, 2014 |
(Unaudited) |
( Expressed in US Dollar) |
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Consolidated Balance Sheets |
(Unaudited) |
September 30, 2014 | December 31, 2013 | |||||
$ | $ | |||||
ASSETS | ||||||
| ||||||
Current Assets | ||||||
Cash and Cash Equivalents | 580,989 | 851,787 | ||||
Prepaid expenses | - | 3,402 | ||||
VAT Receivable | 12,471 | 7,506 | ||||
Total Current Assets | 593,460 | 862,695 | ||||
| ||||||
Total Assets | 593,460 | 862,695 | ||||
| ||||||
LIABILITIES | ||||||
| ||||||
Current Liabilities | ||||||
Accounts Payable and Accrued Liabilities | 762,090 | 465,450 | ||||
Term Loan – Related Party (Note 4) | 73,117 | 70,000 | ||||
Total Current Liabilities | 835,207 | 535,450 | ||||
Term Loan – Related Party (Note 4) | - | 770 | ||||
Total Liabilities | 835,207 | 536,220 | ||||
| ||||||
EQUITY | ||||||
| ||||||
Authorized: | 67,036 | 67,036 | ||||
Additional Paid-in Capital | 5,120,359 | 4,889,441 | ||||
(Deficit) Accumulated During the Development Stage | (5,701,566 | ) | (4,908,913 | ) | ||
Total Common Stockholders’ (Deficiency) | (514,171 | ) | 47,564 | |||
| ||||||
Non-Controlling Interests | 272,424 | 278,911 | ||||
Total Equity | (241,747 | ) | 326,475 | |||
Total Liabilities and Equity | 593,460 | 862,695 |
The accompanying notes are an integral part of these consolidated financial statements.
F-2
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Consolidated Statements of Operations and Comprehensive Loss |
(Unaudited) |
For the period | |||||||||||||||
Three | Nine | from November | |||||||||||||
months | Three months | Nine months | months | 16, 2009 | |||||||||||
ended | ended | ended | ended | (inception) to | |||||||||||
September | September | September | September | September 30, | |||||||||||
30, 2014 | 30, 2013 | 30, 2014 | 30, 2013 | 2014 | |||||||||||
General and Administrative Expenses | $ | $ | $ | $ | $ | ||||||||||
Accounting Fees | 6,000 | 6,000 | 18,000 | 18,000 | 62,779 | ||||||||||
Audit & Tax Fees | 6,625 | 4,035 | 41,835 | 25,735 | 134,421 | ||||||||||
Bank Fees | 126 | 81 | 486 | 376 | 4,943 | ||||||||||
Amortization Expenses – Web Development | - | - | - | - | 3,490 | ||||||||||
Consulting Fees | 135,803 | 146,353 | 423,977 | 431,977 | 1,295,480 | ||||||||||
Filing and Transfer Agent Fees | 1,678 | 655 | 8,319 | 6,957 | 60,515 | ||||||||||
Legal Fees | (786 | ) | 14,993 | 19,762 | 83,899 | 253,840 | |||||||||
Travel Expenses | 1,944 | - | 7,583 | 3,754 | 35,468 | ||||||||||
Office and Miscellaneous Expense | 1,751 | 1,677 | 7,493 | 4,288 | 20,615 | ||||||||||
Research and Development Expense | 117,138 | 55,126 | 329,551 | 84,387 | 4,294,621 | ||||||||||
Marketing Expense | (10 | ) | 10,318 | 512 | 86,496 | 183,307 | |||||||||
Insurance Expense | 4,347 | - | 44,254 | 23,308 | 66,026 | ||||||||||
Stock-Based Compensation (Note 7) | 3,479 | (7,626 | ) | 11,813 | 1,998 | 114,395 | |||||||||
Meals & Entertainment Expenses | 68 | - | 420 | 238 | 1,504 | ||||||||||
| 278,163 | 231,612 | 914,005 | 771,413 | 6,531,404 | ||||||||||
| |||||||||||||||
(Loss) Before Other Expense | (278,163 | ) | (231,612 | ) | (914,005 | ) | (771,413 | ) | (6,531,404 | ) | |||||
Other Expense | |||||||||||||||
Interest Expense | (792 | ) | (1,868 | ) | (2,913 | ) | (5,577 | ) | (25,689 | ) | |||||
Write-off of Website Development Costs | - | - | - | - | (5,485 | ) | |||||||||
Gain related to dissolved subsidiary | - | - | - | 430 | 430 | ||||||||||
Foreign Currency Gain (Loss) | (2,107 | ) | (7,035 | ) | 30,116 | 12,868 | 54,447 | ||||||||
| (281,062 | ) | (240,513 | ) | (886,802 | ) | (763,692 | ) | (6,507,701 | ) | |||||
| |||||||||||||||
Net (Loss) and Comprehensive (Loss) forthe Period | (281,062 | ) | (240,513 | ) | (886,802 | ) | (763,692 | ) | (6,507,701 | ) | |||||
| |||||||||||||||
Net (Loss) and Comprehensive (Loss)attributable to: | |||||||||||||||
Common Stockholders | (251,224 | ) | (221,643 | ) | (792,653 | ) | (703,776 | ) | (5,701,566 | ) | |||||
Non-Controlling Interests | (29,838 | ) | (18,870 | ) | (94,149 | ) | (59,916 | ) | (806,135 | ) | |||||
| (281,062 | ) | (240,513 | ) | (886,802 | ) | (763,692 | ) | (6,507,701 | ) | |||||
Basic and Diluted Net Loss per CommonShare | (0.00 | ) | (0.00 | ) | (0.00 | ) | (0.00 | ) | |||||||
| |||||||||||||||
Weighted Average Number of CommonShares Outstanding – Basic and Diluted | 82,636,433 | 82,636,433 | 82,636,433 | 82,636,433 |
The accompanying notes are an integral part of these consolidated financial statements.
F-3
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Consolidated Statements of Equity (Deficiency) |
For the period from November 16, 2009 to September 30, 2014 |
(Unaudited) |
(Deficit) | |||||||||||||||||||||
Accumulated | Total | ||||||||||||||||||||
Additional | During the | Common | Non- | Total | |||||||||||||||||
Common Stock | Paid In | Development | Shareholders’ | Controlling | Equity | ||||||||||||||||
Shares | Amount | Capital | Stage | Deficiency | Interests | (Deficiency) | |||||||||||||||
$ | $ | $ | $ | $ | $ | ||||||||||||||||
Shares issued for cash at $0.0001 per share on November 16, 2009 | 1,000 | - | - | - | - | - | - | ||||||||||||||
| |||||||||||||||||||||
Shares issued for cash at $0.000025 per share on December 5, 2009 | 15,999,000 | 400 | - | - | 400 | - | 400 | ||||||||||||||
| |||||||||||||||||||||
Net loss for the period | - | - | - | (1,179 | ) | (1,179 | ) | - | (1,179 | ) | |||||||||||
| |||||||||||||||||||||
Balance December 31, 2009 | 16,000,000 | 400 | - | (1,179 | ) | (779 | ) | - | (779 | ) | |||||||||||
| |||||||||||||||||||||
Recapitalization – ODT | 2,000,100 | 2,000 | 6,999 | - | 8,999 | - | 8,999 | ||||||||||||||
| |||||||||||||||||||||
Imputed interest from shareholders | - | - | 3,009 | - | 3,009 | - | 3,009 | ||||||||||||||
| |||||||||||||||||||||
Net loss for the year | - | - | - | (66,056 | ) | (66,056 | ) | - | (66,056 | ) | |||||||||||
| |||||||||||||||||||||
Balance December 31, 2010 | 18,000,100 | 2,400 | 10,008 | (67,235 | ) | (54,827 | ) | - | (54,827 | ) | |||||||||||
| |||||||||||||||||||||
Shares issued for cash at $0.01 per share on February 24th, 2011 | 6,000,000 | 6,000 | 54,000 | - | 60,000 | - | 60,000 | ||||||||||||||
| |||||||||||||||||||||
Imputed interest from shareholders | - | - | 6,199 | - | 6,199 | - | 6,199 | ||||||||||||||
| |||||||||||||||||||||
Restructured term loan – a related party | - | - | 15,833 | - | 15,833 | - | 15,833 | ||||||||||||||
| |||||||||||||||||||||
Net loss for the year | - | - | - | (100,394 | ) | (100,394 | ) | (100,394 | ) | ||||||||||||
| |||||||||||||||||||||
Balance December 31, 2011 | 24,000,100 | 8,400 | 86,040 | (167,629 | ) | (73,189 | ) | - | (73,189 | ) | |||||||||||
| |||||||||||||||||||||
Shares issued for cash at $0.001 per share on April 9, 2012 | 17,750,000 | 17,750 | - | - | 17,750 | - | 17,750 | ||||||||||||||
| |||||||||||||||||||||
Shares issued for cash at $0.001 per share on May 23, 2012 | 12,000,000 | 12,000 | - | - | 12,000 | - | 12,000 | ||||||||||||||
| |||||||||||||||||||||
Shares issued on debt settlement at $0.0075 per share on July 10, 2012 | 8,000,000 | 8,000 | 52,000 | - | 60,000 | - | 60,000 | ||||||||||||||
| |||||||||||||||||||||
Shares issued for cash at $0.01 per share on July 23, 2012 | 3,413,000 | 3,413 | 30,717 | - | 34,130 | - | 34,130 | ||||||||||||||
| |||||||||||||||||||||
Shares issued on debt settlement at $0.01 per share on July 23, 2012 | 500,000 | 500 | 4,500 | - | 5,000 | - | 5,000 | ||||||||||||||
| |||||||||||||||||||||
Shares issued on debt settlement at $0.01 per share on November 16, 2012 | 14,873,333 | 14,873 | 133,860 | - | 148,733 | - | 148,733 | ||||||||||||||
| |||||||||||||||||||||
Shares issued on debt settlement at $0.01 per share on November 23, 2012 | 2,100,000 | 2,100 | 18,900 | - | 21,000 | - | 21,000 | ||||||||||||||
| |||||||||||||||||||||
Warrant certificate issued in subsidiary | - | - | - | - | - | 674,381 | 674,381 | ||||||||||||||
| |||||||||||||||||||||
Change ownership of Savicell | - | - | 3,486,494 | - | 3,486,494 | - | 3,486,494 | ||||||||||||||
| |||||||||||||||||||||
Stock Option Expense | 97,500 | 97,500 | 97,500 | ||||||||||||||||||
| |||||||||||||||||||||
Share issuance costs | - | (5,900 | ) | - | (5,900 | ) | (5,900 | ) | |||||||||||||
| |||||||||||||||||||||
Net loss for the year | - | - | - | (3,801,550 | ) | (3,801,550 | ) | (632,219 | ) | (4,433,769 | ) | ||||||||||
| |||||||||||||||||||||
Balance December 31, 2012 | 82,636,433 | 67,036 | 3,904,111 | (3,969,179 | ) | 1,968 | 42,162 | 44,130 | |||||||||||||
| |||||||||||||||||||||
Change ownership of Savicell | - | - | 980,248 | - | 980,248 | 316,516 | 1,296,764 | ||||||||||||||
| |||||||||||||||||||||
Stock Option Expense | 5,082 | 5,082 | 5,082 | ||||||||||||||||||
| |||||||||||||||||||||
Net loss for the year | - | - | - | (939,734 | ) | (939,734 | ) | (79,767 | ) | (1,019,501 | ) | ||||||||||
| |||||||||||||||||||||
Balance December 31, 2013 | 82,636,433 | 67,036 | 4,889,441 | (4,908,913 | ) | 47,564 | 278,911 | 326,475 | |||||||||||||
| |||||||||||||||||||||
Stock Option Expense | - | - | 11,813 | - | 11,813 | - | 11,813 | ||||||||||||||
| |||||||||||||||||||||
Change ownership of Savicell | - | - | 219,105 | - | 219,105 | 87,662 | 306,767 | ||||||||||||||
| |||||||||||||||||||||
Net loss for the period | - | - | - | (792,653 | ) | (792,653 | ) | (94,149 | ) | (886,802 | ) | ||||||||||
| |||||||||||||||||||||
Balance September 30, 2014 | 82,636,433 | 67,036 | 5,120,359 | (5,701,566 | ) | (514,171 | ) | 272,424 | (241,747 | ) |
The accompanying notes are an integral part of these consolidated financial statements.
F-4
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Consolidated Statements of Cash Flows |
Unaudited |
From | |||||||||
November 16, | |||||||||
Nine months | Nine months | 2009 | |||||||
ended | ended | (inception) to | |||||||
September | September 30, | September 30, | |||||||
30, 2014 | 2013 | 2014 | |||||||
Cash flow from (Used in) Operating Activities | $ | $ | $ | ||||||
Net loss for the period | (886,802 | ) | (763,692 | ) | (6,507,701 | ) | |||
Adjustment for items not involving cash: | |||||||||
Stock-Based Compensation | 11,813 | 1,998 | 114,395 | ||||||
Shares Issued for Consulting Services | - | - | 234,733 | ||||||
Imputed Interest | 2,347 | 4,118 | 24,096 | ||||||
Research and Development Expense | - | - | 2,998,682 | ||||||
Gain related to dissolved subsidiary | - | (430 | ) | (430 | ) | ||||
Amortization – Website Development Costs | - | - | 3,490 | ||||||
Write-off of Website Developments Costs | - | - | 5,485 | ||||||
Changes in non-cash working capital items: | |||||||||
(Increase) decrease in VAT receivable | (4,965 | ) | 152,761 | (12,472 | ) | ||||
(Increase) decrease in Prepaid Expense | 3,402 | - | 3,402 | ||||||
Increase (decrease) in Accounts Payable and Accrued Liabilities | 292,430 | (144,375 | ) | 744,047 | |||||
Net Cash (Used in) Operating Activities | (581,775 | ) | (749,620 | ) | (2,392,273 | ) | |||
Cash flow from Financing Activities | |||||||||
Common Shares Issued, Net of Issuance Costs | - | - | 118,380 | ||||||
Non-Controlling Interests | 310,977 | 1,244,822 | 2,769,935 | ||||||
Increase (Decrease) in Loan Payable – Related Parties | - | - | 74,462 | ||||||
Net Cash Provided by Financing Activities | 310,977 | 1,244,822 | 2,962,777 | ||||||
Cash flow from Investing Activities | |||||||||
Cash Acquired on Acquisition of A Subsidiary | - | - | 14,910 | ||||||
Website Development Costs | - | - | (4,425 | ) | |||||
Net Cash Provided by (Used in) InvestingActivities | - | - | 10,485 | ||||||
Net Increase (Decrease) in Cash and Cashequivalents | (270,798 | ) | 495,202 | 580,989 | |||||
| |||||||||
Cash and Cash equivalents, Beginning of Period | 851,787 | 414,478 | - | ||||||
Cash and Cash equivalents, End of Period | 580,989 | 909,680 | 580,989 | ||||||
Supplementary Information | |||||||||
Interest Paid | - | - | - | ||||||
Income Taxes Paid | - | - | - |
The accompanying notes are an integral part of these consolidated financial statements
F-5
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Notes to the Consolidated Financial Statements |
September 30, 2014 |
(Unaudited) |
Note 1 - Nature of Operations
Online Disruptive Technologies, Inc. (“ODT” or the “Company”) was incorporated on November 16, 2009 in the State of Nevada, U.S.A. The Company was in the business of operating websites with advertising revenue platforms. However, as described below, the Company changed its primary business focus to the development and commercialization of a biotechnology platform. The Company has limited operations and in accordance with ASC 915, is considered a development stage company that has had no revenues from inception to date. The Company has a December 31 year-end.
Effective March 24, 2010, the Company acquired 100% of the issued and outstanding shares of RelationshipScoreboard.com Entertainment Inc. (“RS” or “RelationshipScoreboard.com”), a company incorporated on November 16, 2009 in the state of Nevada, U.S.A. in exchange for 16,000,000 shares of the Company’s common stock. Upon the completion of the acquisition, the former sole shareholder of RS held 89% of the Company’s issued and outstanding common stock. As a result, the transaction was accounted for as a reverse takeover transaction (“RTO”) for accounting purpose, as RS was deemed to be the acquirer, and these consolidated financial statements are a continuation of the financial statements of RS. On January 28, 2013, RelationshipScoreboard.com was closed and dissolved. The Company sold the website assets for $10 to an arm’s length individual and wrote off all supplier payables in the amount of $430.
On April 23, 2012, the Company established an Israeli subsidiary named Savicell Diagnostic Ltd. (“Savicell”) with the intention of exploring business ventures in the biotechnology sector. On July 25, 2012, Savicell entered into a definitive licensing agreement with a division of Tel Aviv University for the purpose of developing and commercializing a new technology relative to the early detection of various forms of disease. With the consummation of this transaction, the Company is now entirely focused on its biotechnology efforts.
These consolidated financial statements have been prepared with the ongoing assumption that the Company will be able to realize its assets and discharge its liabilities in the normal course of business. The Company has working capital deficiency of ($241,747) as at September 30, 2014 (working capital of $327,245 as at December 31, 2013) and an accumulated deficit of $5,701,566. Furthermore, additional future losses are anticipated which raise substantial doubt about the Company’s ability to continue as a going concern. These consolidated financial statements do not include any adjustments to the amounts and classification of assets and liabilities that might be necessary should the Company be unable to continue as a going concern.
The operations of the Company have primarily been funded by the sale of common shares and loans received. Continued operations of the Company are dependent on the Company’s ability to complete equity financings or to generate profitable operations in the future. Management’s plan in this regard is to secure additional funds through future equity financings. Such financings may not be available or may not be available on reasonable terms to the Company.
F-6
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Notes to the Consolidated Financial Statements |
September 30, 2014 |
(Unaudited) |
Note 2 - Significant Accounting Policies
a) | Basis of Presentation |
These financial statements have been prepared in conformity with generally accepted accounting principles in the United States of America (“US GAAP”). All adjustments considered necessary for a fair presentation of financial position, results of operations and cash flows as at September 30, 2014 have been included. | |
b) | Principles of Consolidation |
These consolidated financial statements include the accounts of the Company, its former wholly-owned subsidiary RS and its 74.67% interest in Savicell. All significant intercompany accounts and transactions have been eliminated upon consolidation. | |
c) | Use of Estimates |
The preparation of financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures 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 those estimates. | |
d) | Foreign Currency Translation |
The Company and its subsidiaries’ functional currency are U.S. dollars. Transactions in other currencies are recorded in U.S. dollars at the rates of exchange prevailing when the transactions occur. Monetary assets and liabilities denominated in other currencies are translated into U.S. dollars at rates of exchange in effect at the balance sheet dates. Exchange gains and losses are recorded in the statements of operations. | |
e) | Cash and Cash Equivalents |
Cash and cash equivalents consist entirely of readily available cash balances. There were no cash equivalents as of September 30, 2014 and December 31, 2013. The cash and cash equivalents are deposited with various high credit quality financial institutions and may exceed federally insured limits throughout the year. | |
f) | Stock- based Compensation |
Company accounts for its stock-based compensation awards in accordance with ASC Topic 718, Compensation—Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, including grants of employee stock options, to be recognized as expense in the statements of operations based on their grant date fair values. For stock options granted to employees and to members of the Board of Directors for their services on the Board of Directors, the Company estimates the grant date fair value of each option award using the Black-Scholes option-pricing model. The use of the Black- Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the common stock. | |
Share-based payments issued to non-employees are recorded at their fair values, and are periodically revalued as the equity instruments vest and are recognized as expense over the related service period in accordance with the provisions of ASC 718 and ASC Topic 505, Equity. For equity instruments granted to non-employees, the Company recognizes stock-based compensation expense on a straight-line basis. |
F-7
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Notes to the Consolidated Financial Statements - Audited |
September 30, 2014 |
(Unaudited) |
Note 2 - Significant Accounting Policies(Continued)
For the nine months ended September 30, 2014, the Company incurred stock compensation expense of $11,813. For the corresponding period of 2013, the stock compensation expense was $1,998
g) | Income Taxes |
Income taxes are accounted for under the liability method of accounting for income taxes. Under the liability method, deferred tax liabilities and assets are recognized for the estimated future tax consequences attributable to differences between the amounts reported in the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted income tax rates expected to apply when the asset is realized or the liability is settled. The effect of a change in income tax rates on deferred tax liabilities and assets is recognized in income in the period in which the change occurs. Deferred tax assets are recognized to the extent that they are considered more likely than not to be realized. | |
The Financial Accounting Standards Board (FASB) has issued FASB ASC 740-10, “Accounting for Uncertainty in Income Taxes”. ASC 740-10 clarifies the accounting for uncertainty in income taxes recognized in an enterprise’s financial statements in accordance with prior literature FASB Statement No. 109, Accounting for Income Taxes. This standard requires a company to determine whether it is more likely than not that a tax position will be sustained upon examination based upon the technical merits of the position. If the more-likely-than-not threshold is met, a company must measure the tax position to determine the amount to recognize in the financial statements. The implementation of this standard had no impact on the Company’s financial statements. | |
h) | Comprehensive Income (Loss) |
The Company accounts for comprehensive income under the provisions of ASC Topic 220-10,Comprehensive Income -Overall, which establishes standards for reporting and display of comprehensive income, its components and accumulated balances. The Company is disclosing this information on its Statements of Operations and Comprehensive Loss. | |
i) | Earnings (Loss) Per Share |
Basic loss per share is computed on the basis of the weighted average number of common shares outstanding during each period. | |
Diluted loss per share is computed on the basis of the weighted average number of common shares and dilutive securities outstanding. Stock options are considered to be common stock equivalents and were not included in the net loss per share calculation for the nine months ended September 30, 2014 and December 31, 2013 because the inclusion of such underlying shares would have had an anti-dilutive effect. |
F-8
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Notes to the Consolidated Financial Statements |
September 30, 2014 |
(Unaudited) |
Note 2 - Significant Accounting Policies(Continued)
k) | Financial Instruments and Fair Value of Financial Instruments |
Fair Value of Financial Instruments – the Company adopted SFAS ASC 820-10-50, “Fair Value Measurements”. This guidance defines fair value, establishes a three-level valuation hierarchy for disclosures of fair value measurement and enhances disclosure requirements for fair value measures. The three levels are defined as follows: |
- | Level 1 inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets. | |
- | Level 2 inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the financial instrument. | |
- | Level 3 inputs to valuation methodology are unobservable and significant to the fair measurement. |
As at September 30, 2014, the fair value of cash and cash equivalents was measured using Level 1 inputs.
The carrying amounts reported in the consolidated balance sheets for the cash and cash equivalents, accounts payable and accrued liabilities, loans payable and term loan (current portion) each qualify as financial instruments and are a reasonable estimate of fair value because of the short period of time between the origination of such instruments and their expected realization.
l) | Website Development Costs |
Website development costs relate to the development of the Company's proprietary website. These costs had been capitalized as incurred and installed and were, prior to being written off in full (see Note 4 below), amortized over the estimated useful life of three years on a straight line basis. The Company accounts for these costs in accordance with ASC 350,Intangibles,which specifies the appropriate accounting for costs incurred in connection with the development and maintenance of websites. | |
m) | Research and Development Costs |
All research and development costs are charged to expense as incurred and consist principally of costs related to the License and Research Funding Agreement entered by the Company’s subsidiary with Ramot at Tel Aviv University (See Note 3). |
F-9
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Notes to the Consolidated Financial Statements |
September 30, 2014 |
(Unaudited) |
Note 2 - Significant Accounting Policies(Continued)
n) | Recently Adopted Accounting Pronouncements |
In March 2013, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update ("ASU") 2013- 05, "Foreign Currency Matters (Topic 830); Parent’s Accounting for the Cumulative Translation Adjustment upon Derecognition of Certain Subsidiaries or Groups of Assets within a Foreign Entity or of an Investment in a Foreign Entity." This guidance applies to the release of the cumulative translation adjustment into net income when a parent either sells a part or all of its investment in a foreign entity or no longer holds a controlling financial interest in a subsidiary or group of assets that is a business (other than a sale of in substance real estate or conveyance of oil and gas mineral rights) within a foreign entity. ASU No. 2013-05 is effective prospectively for fiscal years (and interim reporting periods within those years) beginning after December 15, 2013. The Company adopted ASU 2013-05 on January 1, 2014 and the adoption of this pronouncement did not have a material effect on the Company's consolidated financial position or results of operations. | |
In July 2013, the FASB issued authoritative guidance under Accounting Standard Update ("ASU") 2013- 11, which provides guidance on the financial statement presentation of an unrecognized tax benefit when a net operating loss (“NOL”) carryforward, a similar tax loss, or a tax credit carryforward exists. ASU 2013-11 requires entities to present an unrecognized tax benefit as a reduction of a deferred tax asset for a NOL or tax credit carryforward whenever the NOL or tax credit carryforward would be available to reduce the additional taxable income or tax due if the tax position is disallowed. This accounting standard update requires entities to assess whether to net the unrecognized tax benefit with a deferred tax asset as of the reporting date. ASU 2013-11 will be effective for the Company’s first quarter of fiscal 2014. The Company adopted ASU 2013- 11 on January 1, 2014 and the adoption of this pronouncement did not have a material effect on the Company's consolidated financial position or results of operations. |
o) | Recently Issued Accounting Pronouncements |
In May 2014, the Financial Accounting Standards Board issued Accounting Standards Update (ASU) 2014 -09, Revenue from Contracts with Customers (ASU 2014- 09). This accounting standard supersedes all existing US GAAP revenue recognition guidance. Under ASU 2014-09, a company will recognize revenue when it transfers the control of promised goods or services to customers in an amount that reflects the consideration which the company expects to collect in exchange for those goods or services. ASU 2014 -09 will require additional disclosures in the notes to the consolidated financial statements and is effective for annual and interim reporting periods beginning after December 15, 2016. The Company is evaluating the impact of ASU 2014-09 and an estimate of the impact to the consolidated financial statements cannot be made at this time. | |
There have been no other accountings pronouncements issued but not yet adopted by the Company which are expected to have a material impact on the Company’s financial position, results of operations or cash flows. |
Note 3 – License and Research Funding Agreement
On July 25, 2012, the Company’s subsidiary Savicell entered into a License and Research Funding Agreement (“R&D Agreement”) with Ramot at Tel Aviv University (“Ramot”) pursuant to which:
• | In the course of research performed at Tel-Aviv University ("TAU"), Prof. Fernando Patolsky has developed technology relating to early detection of diseases by measuring metabolic activity in the immune system; |
F-10
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Notes to the Consolidated Financial Statements |
September 30, 2014 |
(Unaudited) |
Note 3 – License and Research Funding Agreement(continued)
• | Savicell wishes to fund further research at TAU relating to such technology; and |
• | Savicell wishes to obtain a license from Ramot with respect to such technology and the results of such further funded research in order to develop and commercialize products in the diagnostics space, and Ramot wishes to grant the Company such license, all in accordance with the terms and conditions of this R&D Agreement. |
Pursuant to the above noted R&D Agreement, Savicell will fund research expenditures amounting to a total of $1,600,000 according to the following schedule:
• | $81,000 within 5 business days of the R&D Agreement (paid) |
• | Before October 2012; $359,500 plus VAT as applicable (paid) |
• | Before January 3, 2013; $359,500 plus VAT as applicable (paid) |
• | Before April 3, 2013; $400,000 plus VAT as applicable |
• | Before July 3, 2013; $400,000 plus VAT as applicable |
The payments originally due on April 3, 2013 and July 3, 2013 have been postponed by the parties until such time as the funds are actually required in furtherance of the joint research and development initiatives.
In addition, Savicell agreed to issue to Ramot warrants (the “Warrants”) to purchase a number of ordinary shares of Savicell which shall together comprise 15% of issued shares of Savicell on an as-converted, fully diluted basis (equivalent to 1,765 Warrant Shares of Savicell). The Warrants shall be exercisable at an exercise price equal to the par value of the Warrant Shares, at any time and from time to time or until Savicell completes a defined liquidity event. The fair value of the Warrant Shares has been estimated at $1,698.97 per Warrant Share which is equivalent to the price at which Savicell has issued shares to third party, for a total of $2,998,682.
Upon successful development and commercialization and in recognition of the rights and licenses granted to Savicell pursuant to this R&D Agreement, Savicell will be subject to certain royalty payments as specified in the Agreement.
During the year ended December 31, 2012, Savicell incurred research and development of $3,830,135 which included the funding of $831,453 in connection with R&D Agreement and the fair value ($2,998,682) of Warrant Shares issued to Ramot.
During the year ended December 31, 2013, Savicell incurred research and development cost of $134,935 which were included in the consolidated statements of operations and comprehensive loss.
During the nine months ended September 30, 2014, Savicell incurred research and development cost of $329,551 (September 30, 2013 - $84,387) which were included in the consolidated statements of operations and comprehensive loss.
Note 4 – Term Loan – Related Party
On November 4, 2011, the Company entered into a loan Agreement (“Loan Agreement”) with a shareholder of the Company to settle a loan payable in the amount of $74,062. Pursuant to the Loan Agreement, the terms of repayment were amended to specify that ten per cent (10%) of the gross proceeds of any prospective debt or equity financing undertaken by ODT would be applied to the repayment of the principal of this loan until fully repaid. The term loan is unsecured, non-interest bearing and requires that any balance remaining outstanding on November 4, 2016 would then be fully due and payable.
F-11
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Notes to the Consolidated Financial Statements |
September 30, 2014 |
(Unaudited) |
Note 4 – Term Loan – Related Party(continued)
The Company’s management has estimated that ODT will raise equity financing of $500,000 in each of 2014 and 2015 such that the loan payable will be fully repaid upon the equity raise in 2015. Management had determined the net present value of the term loan as at the date of restructuring to be $58,229 by discounting the future anticipated repayments at a relative market rate of 11.68% . As a result of the restructuring, the Company recorded $15,833 of additional paid-in capital. During the nine months ended September 30, 2014, the Company recorded interest accretion of $2,347 (September 30, 2013 - $4,115).
A summary of the Term Loan is as follows:
September 30, 2014 | December 31, 2013 | |||||
Term loan – face value | $ | 74,062 | $ | 74,062 | ||
Effective interest rate – 11.68% | (15,833 | ) | (15,833 | ) | ||
Net present value | 58,229 | 58,229 | ||||
Interest accretion | 14,888 | 12,541 | ||||
Total | 73,117 | 70,770 | ||||
Current portion | 73,117 | 70,000 | ||||
Term loan – long term | $ | - | $ | 770 |
Note 5 – Loans Payable – Related Parties
During the year ended December 31, 2013, In connection with the dissolution of RS, a $400 loan payable owing to a shareholder of the Company was written off.
Note 6 – Related Party Transactions
The Company completed the following related party transactions:
During the nine months ended September 30, the Company incurred consulting fees of $423,977, payable to its directors and officers and companies controlled by such directors and officers (for nine months ended September 30, 2013 - $431,977).
As at September 30, 2014, included in accounts payable and accrued liabilities, $144,233 (December 31, 2013 - $88,433) was payable to a company controlled by a former director/officer of the Company and $594,977 (December 31, 2013 -$343,965) was payable to current officers or directors of the Company.
See Note 4, 5 and 7.
Note 7 –Equity
Common shares
On March 24, 2010, the Company issued 16,000,000 common shares (restricted shares) to the sole shareholder of RS to effect the acquisition and RTO. Prior to the acquisition and RTO (Note 1 and 2), RS engaged in the following equity transactions which have been restated using the exchange ratio established in the acquisition agreement to reflect 16,000,000 common shares issued in the reverse acquisition:
F-12
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Notes to the Consolidated Financial Statements |
September 30, 2014 |
(Unaudited) |
Note 7 –Equity(Continued)
Common shares(continued)
- | On November 16, 2009, RS issued 1,000 common shares at $0.0001 per share for total proceeds of $0.10. |
- | On December 5, 2009, RS issued 15,999,000 common shares at $0.000025 per share for total proceeds of $400. |
Prior to the acquisition and RTO (Note 1 and 2), the Company engaged in the followings equity transactions:
- | On November 16, 2009, the Company issued 100 common shares at $0.001 per share for total proceeds of $0.10. |
- | On December 2, 2009, the Company issued 200,000 common shares at $0.01 per share for total proceeds of $2,000. |
- | On January 7, 2010, the Company issued 1,800,000 common shares at $0.01 per share for total proceeds of $18,000. |
Upon the acquisition and RTO, 2,000,100 common shares issued by the Company prior to the acquisition were considered as a recapitalization to RS.
On February 24, 2011, the Company issued 6,000,000 common shares at $0.01 per share for total proceeds of $60,000.
On April 9, 2012, the Company issued 17,750,000 common shares at $0.001 per share for total proceeds of $17,750.
On May 23, 2012, the Company issued 12,000,000 common shares at $0.001 per share for total proceeds of $12,000.
The share issuance cost in connection with the issuance of 29,750,000 common shares was $5,900.
On July 10, 2012, the Company entered into debt settlement agreements with nine individuals whereby the Company collectively settled debts in the aggregate amount of $60,000 by the issuance of 8,000,000 common shares at a price per share of $0.0075. Included in the $60,000 total were the two loans of $25,000 each described more fully in Note 6 (Loans Payable – Related Parties).
On July 23, 2012, the Company issued 3,413,000 common shares at $0.01 per share for total proceeds of $34,130 and an additional 500,000 shares were issued as part of a debt settlement agreement in which $5,000 of an accounts payable debt was settled.
On November 16, 2012, the Company entered into debt settlement agreements with six employees or consultants of the Company whereby the Company collectively settled debts in the aggregate amount of $148,733 by the issuance of 14,873,333 common shares at a price per share of $0.01.
On November 23, 2012, the Company entered into debt settlement agreements with one director and one consultant of the Company pursuant to which the Company collectively settled debts in the aggregate amount of $26,000 by the issuance of 2,100,000 common shares at a price per share of $0.01 and a cash payment of $5,000.
As at September 30, 2014 and December 31, 2013 the Company has 82,636,433 common shares issued and outstanding.
F-13
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Notes to the Consolidated Financial Statements |
September 30, 2014 |
(Unaudited) |
Note 7 –Equity(Continued)
Stock Options
On September 1, 2012, the Company granted a total of 9,750,000 stock options to our directors, officers, consultants and employees. The stock options are exercisable at the exercise price of $0.01 per share until September 1, 2022 and vest immediately.
On May 28, 2013, the Company granted a total of 962,358 stock options to a consultant. The stock options are exercisable at an exercise price of $0.01 per share. A quarter of the options will vest on each of the first four anniversaries of the date of initial grant. The options were valued based on the Black Scholes model which utilizes the following assumptions: expected dividend yield of nil, expected volatility of 72.99 - 95.69%, expected life of 4 years and risk free interest rate of 0.48 - 0.90%.
On August 22, 2013, the Company granted a total of 800,000 stock options to a consultant. The stock options are exercisable at the exercise price of $0.01 per share. 480,000 of the options so granted will vest as to one quarter of such options at the end of each completed year that the consultant provides the services. The remaining 320,000 options will be fully vest when the consultant has completed the provision of a minimum of 600 blood samples of lung cancer and control patients during the 4 years from August 22, 2013. One twelfth of these options will vest upon each 50 blood samples having been delivered by the consultant to the Company. As at September 30, 2014 the consultant has delivered 140 blood samples.
On November 11, 2013, the Company granted a total of 1,924,717 stock options to a consultant. The stock options are exercisable at an exercise price of $0.01 per share. A quarter of the options will vest immediately and a quarter on each of the first three anniversaries of the date of initial grant. The options were valued based on the Black Scholes model which utilizes the following assumptions: expected dividend yield of nil, expected volatility of 79.60 -81.02%, expected life of 3 years and risk free interest rate of 0.65 - 0.78% .
On January 1, 2014, the Company granted 500,000 stock options to a senior research consultant. The stock options are exercisable at an exercise price of $0.01 per share. One-third of the options shall vest and become exercisable at the end of each completed year that the consultant provides services to the Company.
On May 4, 2014, the Company granted 150,000 stock options to a research consultant. The stock options are exercisable at an exercise price of $0.01 per share. One-third of the options shall vest and become exercisable at the end of each completed year that the consultant provides services to the Company.
On May 15, 2014, the Company granted 150,000 stock options to a research statistician. The stock options are exercisable at an exercise price of $0.01 per share. 25,000 options shall vest upon commencement of employment on May 15, 2014. 75,000 options shall vest and become exercisable upon the first completed year that the consultant provides services to the Company. The remaining 50,000 options shall vest and become exercisable upon the second completed year that the consultant continues to provide services to the Company.
For the nine months ended September 30, 2014, Company recorded stock based compensation of $11,813 for the above options. The options were valued based on the Black Scholes model which utilizes the following assumptions: expected dividend yield of nil, expected volatility of 76 - 88%, expected life of 3 years and risk free interest rate of 0.76 - 0.88% .
F-14
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Notes to the Consolidated Financial Statements |
September 30, 2014 |
(Unaudited) |
Note 7 –Equity(Continued)
Stock Options(continued)
Weighted | |||||||||
Average Exercise | |||||||||
Number of Options | Price | Expire date | |||||||
Balance, December 31, 2011 | - | $ | - | ||||||
Granted | 9,750,000 | 0.01 | September 1, 2022 | ||||||
Balance, December 31, 2012 | 9,750,000 | 0.01 | |||||||
Granted, on May 28, 2013 | 962,358 | 0.01 | May 28, 2018 | ||||||
Granted, on August 22, 2013 | 800,000 | 0.01 | August 22, 2018 | ||||||
Granted, on November 11, 2013 | 1,924,717 | 0.01 | November 11, 2020 | ||||||
Balance, December 31, 2013 | 13,437,075 | 0.01 | |||||||
Granted, on January 1, 2014 | 500,000 | 0.01 | January 1, 2019 | ||||||
Granted, on May 4, 2014 | 150,000 | 0.01 | May 4, 2021 | ||||||
Granted, on May 15, 2014 | 150,000 | 0.01 | May 15, 2021 | ||||||
Balance, September 30, 2014 | 14,237,075 | $ | 0.01 |
Exercise price | Outstanding as at September 30, 2014 | Exercisable as at September 30, 2014 | ||||||||||||||||
Weighted | Weighted | |||||||||||||||||
Weighted | Average | Weighted | Average | |||||||||||||||
Average | Remaining | Average | Remaining | |||||||||||||||
Number of | Exercise | Contractual | Number of | Exercise | Contractual | |||||||||||||
Options | Price | Life (years) | Options | Price | Life (years) | |||||||||||||
$ 0.01 | 9,750,000 | $ | 0.01 | 7.93 | 9,750,000 | $ | 0.01 | 7.93 | ||||||||||
0.01 | 962,358 | 0.01 | 3.66 | 240,590 | 0.01 | 3.66 | ||||||||||||
0.01 | 800,000 | 0.01 | 3.90 | 173,374 | 0.01 | 3.90 | ||||||||||||
0.01 | 1,924,717 | 0.01 | 6.12 | 481,179 | 0.01 | 6.12 | ||||||||||||
0.01 | 500,000 | 0.01 | 4.26 | - | - | - | ||||||||||||
0.01 | 150,000 | 0.01 | 6.59 | - | - | - | ||||||||||||
0.01 | 150,000 | 0.01 | 6.63 | - | - | - | ||||||||||||
14,237,075 | $ | 0.01 | 7.01 | 10,645,143 | $ | 0.01 | 7.68 |
Exercise price | Outstanding as at December 31,2013 | Exercisable as at December 31, 2013 | ||||||||||||||||
Weighted | Weighted | |||||||||||||||||
Weighted | Average | Weighted | Average | |||||||||||||||
Average | Remaining | Average | Remaining | |||||||||||||||
Number of | Exercise | Contractual | Number of | Exercise | Contractual | |||||||||||||
Options | Price | Life (years) | Options | Price | Life (years) | |||||||||||||
$ 0.01 | 9,750,000 | $ | 0.01 | 8.67 | 9,750,000 | $ | 0.01 | 8.67 | ||||||||||
0.01 | 962,358 | 0.01 | 4.41 | - | - | |||||||||||||
0.01 | 800,000 | 0.01 | 4.64 | - | - | |||||||||||||
0.01 | 1,924,717 | 0.01 | 6.87 | 481,179 | 0.01 | 6.87 | ||||||||||||
13,437,075 | $ | 0.01 | 7.87 | 10,231,179 | $ | 0.01 | 8.59 |
F-15
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Notes to the Consolidated Financial Statements |
September 30, 2014 |
(Unaudited) |
Note 7 – Equity(Continued)
Non-Controlling Interests
The Company’s subsidiary, Savicell, granted a third party a warrant certificate to purchase 1,765 common shares of Savicell that initially represented 15% of the underlying common equity of Savicell. In the course of its initial equity issuances up to October 30, 2012 (the “Initial Closing”), Savicell issued a total of 592 ordinary shares at $1,698.97 per share to the non-related third party representing approximately 4.79% of the fully diluted common equity of Savicell for aggregate proceeds of $1,005,795. The Savicell investors are entitled to convert their Savicell shares into common shares of ODT at a price equal to 80% of the per share pricing of the first completed ODT financing of over $500,000 conducted after July 1, 2012 (the “Financing Price”) provided that for purposes of such conversion, the deemed maximum Financing Price shall be the per share price of the common shares of ODT based on (a) an aggregate ODT equity valuation of $30,000,000; and (b) the number of common shares of ODT outstanding at the time of the financing. Savicell continued its equity issuances following the Initial Closing.
As at December 31, 2012, Savicell had issued a total of 684 shares at $1,698.97 per share representing approximately 5.18% of the fully diluted common equity of Savicell for aggregate proceeds of $1,162,192.
As at December 31, 2013, Savicell issued a total of 760 shares at $1,700 per share representing approximately 5.75% of the fully diluted common equity of Savicell for aggregate proceeds of $1,292,000.
For the nine months ended September 30, 2014, Savicell issued a total of 183 shares at $1,700 per share representing approximately 1.37% of the fully diluted common equity of Savicell for aggregate proceeds of $310,977. Following these share issuances, the Company, the Warrant holder and the Savicell investors held underlying interests in the equity of Savicell of 74.67%, 13.18% and 10.78% respectively.
As the exercise price inherent in warrant certificate to purchase 1,765 common shares of the Savicell is at nominal value, the warrant certificate is valued at the price of the subsequent equity issuance by Savicell ($1,698.97 per share) and the related common shares are considered to be issued and outstanding.
The Company also entered into a conversion and participation rights agreement (the “Agreement”) with investors who have purchased Savicell’s shares. Pursuant to the Agreement, the Company have permitted the investors to convert the Savicell’s shares into shares of the Company subject to certain conditions.
Note 8 – Commitments and Guarantees
The Company did not become a guarantor to any parties as at September 30, 2014.
1. | Effective November 1, 2011, the Company entered into a consulting agreement with 1367826 Ontario Limited (“OntarioCo”) pursuant to which OntarioCo is to provide certain consulting services to the Company including the provision of accounting, financial and regulatory advice. As consideration for the performance of the consulting services under the agreement, ODT agreed to pay OntarioCo the sum of $4,166.67 per month for the duration of the agreement, exclusive of any applicable sales tax. The agreement is for an indefinite period unless terminated by either party with sixty days advance written notice to the other party. Effective October 1, 2012 the quantum of the monthly fees was increased to $9,000 in recognition of the expanded scope of the Company’s activities. |
F-16
Online Disruptive Technologies, Inc. |
(A Development Stage Company) |
Notes to the Consolidated Financial Statements |
September 30, 2014 |
(Unaudited) |
Note 8 – Commitments and Guarantees(Continued)
2. | Effective November 1, 2011, the Company entered into a consulting agreement with Kerry Chow, pursuant to which she will provide the following consulting services to ODT: maintaining the accounting books and records on behalf of our company and our subsidiaries; preparing consolidated quarterly and annual financial statements for our company and our subsidiaries as well as assisting in the preparation of the related disclosure documents; coordinating the quarterly reviews and annual audits on behalf of our company and our subsidiaries; coordinating the preparation and filing of the annual income tax returns of our company and our subsidiaries; and any other accounting-related functions. As consideration for the performance of the consulting services under the agreement, ODT agreed to pay Kerry Chow the sum of $833.33 per month for the duration of the agreement, exclusive of any applicable sales tax. The agreement is for an indefinite period unless terminated by either party with sixty days advance written notice to the other party. Effective October 1, 2012, the quantum of the monthly fee was increased to $2,000 in recognition of the expanded scope of the Company’s activities. | |
3. | On September 11, 2012, ODT signed an employment agreement with Giora Davidovits, its new chief executive officer and President, which agreement entailed an effective date of September 1, 2012. In return for acting as its chief executive officer, the Company will provide Mr. Davidovits an annual salary of $250,000 together with other benefits and the potential for additional bonuses as declared from time to time by the Company’s board of directors. The agreement will end on August 31, 2017 unless terminated early in accordance with the termination provisions contained within the employment agreement. | |
4. | On October 30, 2012, ODT and Savicell signed an employment agreement with Eyal Davidovits, its new chief operating officer, which agreement entailed an effective date of September 1, 2012. In return for acting as its chief operating officer, the Company will provide Mr. Davidovits an annual salary of NIS 432,000, together with other benefits and the potential for additional bonuses as declared from time to time by the Company’s board of directors. The agreement will end on August 31, 2017 unless terminated early in accordance with the termination provisions contained within the employment agreement. | |
5. | On November 8, 2012, ODT and Savicell signed an employment agreement with Dr. Irit Arbel, its new vice president, research and development, which agreement entailed an effective date of September 1, 2012. In return for acting as its new vice president, research and development officer, the Company will provide Dr. Arbel an annual salary of NIS 408,000 together with other benefits and the potential for additional bonuses as declared from time to time by the Company’s board of directors. The agreement will end on August 31, 2017 unless terminated early in accordance with the termination provisions contained within the employment agreement. |
F-17
3
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward Looking Statements
This quarterly report on Form 10-Q contains forward-looking statements. Forward-looking statements are projections in respect of future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements made in this Form 10-Q include statements about:
• | our anticipation that future broad clinical trial studies encompassing larger populations of cancer patients with varying cancers should reveal the full potential of the existing developed strategy; |
• | our beliefs regarding the future of our competitors; |
• | our belief that there is a large unmet need in cancer diagnostics exists in early diagnosis; accurate diagnosis; |
• | our belief that there is a need in this segment for an easier blood-based test that will increase compliance and minimize discomfort; |
• | our anticipated development schedule; |
• | our expectation that the demand for our products will eventually increase; |
• | our expectation that we will be able to raise capital when we need it; and |
• | our expectation that there is a new market for screening tests. |
These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks in the section entitled “Risk Factors” and the risks set out below, any of which may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. These risks include, by way of example and not in limitation:
• | general economic and business conditions; |
• | our ability to effectively develop our products; |
• | volatility in prices for our products; |
• | risks inherent in the pharmaceutical industry; |
• | competition for, among other things, capital, pharmaceutical products and skilled personnel; and |
• | other factors discussed under the section entitled “Risk Factors”. |
While these forward-looking statements and any assumptions upon which they are based are made in good faith and reflect our current judgment regarding the direction of our business, actual results will almost always vary, sometimes materially, from any estimates, predictions, projections, assumptions or other future performance suggested herein. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results.
As used in this interim report on Form 10-Q and unless otherwise indicated, the terms “we”, “us” and “our” refer to Online Disruptive Technologies Inc. and our subsidiary, Savicell Diagnostic Ltd., an Israeli corporation (the “Subsidiary” or “Savicell”). Unless otherwise specified, all dollar amounts are expressed in United States dollars.
4
Corporate Overview
We were incorporated in the State of Nevada on November 16, 2009 under the name “Online Disruptive Technologies, Inc.” with authorized capital of 500,000,000 shares of common stock with a par value of $0.001 per share and 20,000,000 shares of preferred stock with a par value of $0.001 per share. On March 24, 2010, we entered into a share purchase agreement with Benjamin Cherniak, whereby we acquired all of the issued and outstanding shares of RelationshipScoreboard.com Entertainment, Inc. in consideration for the issuance of 16,000,000 of our common shares. RSE was incorporated in the State of Nevada on November 16, 2009. There were no related party interests in the acquisition of RelationshipScoreboard.com Entertainment, Inc.
Pursuant to a license agreement and research funding agreement (the “License Agreement”) dated July 24, 2012 and entered into on July 25, 2012 executed by our Subsidiary and Ramot at Tel Aviv University Ltd. (“Ramot”), a private company incorporated in the State of Israel and having a place of business at 5 Shenker Street, Herzliah, Israel, our Subsidiary was granted a license to certain patented technology relating to the early detection of diseases by measuring metabolic activity in the immune system (the “Technology”). The products (the “Products”) means any instrument, device, process, method, product, component, or system that contain or is based on, in whole or in part, the Technology.
As consideration for the worldwide exclusive license of the Products, our Subsidiary will pay, issue and fund the following to Ramot:
(a) | a royalty (the “Royalty”) on worldwide net sales of the Products by our company and its affiliates or sublicensee; | |
(b) | a minimum annual royalty, credited against the Royalty; | |
(c) | percentages of all payments received in connection with a sublicense; | |
(d) | issue warrants to purchase, for nominal consideration, the number of common shares of the Subsidiary such that Ramot holds a minority interest in the Subsidiary; and | |
(e) | fund research expenditures for the research of the Technology. |
After the entry into of the License Agreement, we are focused on the development of Savicell.
Our Current Business
Savicell
Savicell uses a revolutionary diagnostic platform that is positioned initially in the cancer diagnostic market. The technology uses blood samples to rapidly measure the body's response to disease intrusion and cell malformation. The immune system is the first to “read” cancer and Savicell interprets the language of the immune system’s response.
Savicell technology is a ground-breaking, high-throughput, in-vitro test for rapid quantitative measurement of the metabolic activity of the cell populations that the body deploys to diagnose disease. Initial application will focus on cancer diagnostics using blood samples. The Savicell patent pending approach maps the different metabolic response profiles as a method for early diagnosis and staging.
The immune system is designed to detect disease intrusion and cell malformation in our bodies, which includes cancer, and to eliminate them. In reaction to the presence of cancer the immune system is energized to respond. The initial reaction is intricate, deploying different metabolic pathways and different subtypes of cells. It is these differential responses that Savicell technology powerfully detects. The immune system is the first to “read” cancer and Savicell interprets the language of the immune system’s response.
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The clinical results obtained show the capability to simply and rapidly diagnose cancer in a preliminary large population of cancer patients in comparison to a control healthy group. We anticipate that future broad clinical trial studies involving larger populations of cancer patients with varying cancers should reveal the full potential of the existing developed strategy.
Obviously, many more tests are required in order to construct a meaningful and significant diagnostic classification. However, what is revealed to date is a major clear-cut shift of immune system metabolic activity pathways from oxidative phosphorylation to aerobic glycolysis between healthy patients and those with various cancer types. Savicell has commenced clinical testing and has realized encouraging early reviews of its breast cancer and lung cancer readouts albeit on a relatively small sample size. Specifically, we were able to distinguish between cancer patients and healthy donors with high sensitivity and specificity (>95%) in breast cancer, lung cancer and in some unspecified cancer groups, again albeit on a relatively small sample size.
Cancer Diagnostic Market
Cancer cases are increasing, with more than 20 million new cases predicted in 2025, compared to 12 million in 2008. (WHO) The worldwide in-vitro diagnostic market is estimated at $44 billion, growing 8% annually Market reseach.com press release Feb 7, 2012 – Yahoo Finance). The cancer diagnostic market is estimated at $8 billion annually and is the fastest growing segment (Kalorama Information Inc. news release March 12, 2008).
Cancer drug and diagnostic markets have grown impressively, driven by expanding patient populations and technological advances, especially in biomolecular medicine. Current treatments are better tolerated and more effective. The introduction of innovative products on the market is expected to continue and to drive double-digit annual growth. Helping to expand the treated patient population, 25 to 30 new anti-cancer agents are expected to be approved for a variety of new indications. (IMS Health Forecasts, Biopharma Forecasts & Trends). Expanding treatment options will further enhance growth of diagnostic products for monitoring treatment response, recurrence, and improved typing/staging. These enhanced treatment options will also accelerate market growth of companion diagnostics by linking sales of diagnostics to therapeutics (Dx-Rx model.). In 2010 alone, 25 companion diagnostics partnerships with pharma were established (pwc Diagnostics 2011 (PricewaterhouseCoopers LLP)).
Product innovations in cancer molecular diagnostics with biomarker discoveries have enhanced patient outcomes and helped drive market growth. However, the difficulty of discovering new bio-markers remains a significant limiting factor to growth. Importantly, the diagnostic efficacy of bio-markers in detecting cancer cells may be greater at relatively advanced stages of the disease, where the cancer growth is more pronounced.
We believe a significant and very large unmet need in cancer diagnostics exists in early diagnosis; accurate diagnosis, especially where technique-based biopsy limits accuracy; staging; diagnosis confirmation; recurrence and treatment monitoring; and tissue of origin diagnosis.
Early detection is very important because it can improve outcomes dramatically. Typically, more treatment options are available when diagnosed early and the resulting survival rates improve. Survival rate improves by at least four times when cancer is diagnosed early and before it has spread. (American Cancer Society) Key issues with current early diagnosis tests include low sensitivity, low specificity, discomfort (e.g., colonoscopy), exposure to radioactivity, and cost.
The early diagnosis market can be divided into two broad segments. One is cancers with commercialized diagnostic tests. These generate multibillion dollars that are significantly supported by the existence of guidelines. Breast and colon cancers are examples, with guidelines for mammograms yearly and colonoscopies every 5 to 10 years. There are 14.5 million annual screening tests for colon cancer in the USA (Anesth Analg 2008;106:434 –9). There are estimated at 40 million mammograms annually (FDA news release Feb. 11, 2011). We believe that there is a need in this segment for an easier blood-based test that will increase compliance and minimize discomfort.
The second segment is comprised of cancers that lack early diagnostic solutions. For example, lung and ovarian cancers do not have good screening tests and we believe represent a new market. Organizations that determine guidelines already support a screening regimen for ovarian cancer. So, once a reliable test is developed, market adaptation should be faster because the need has already been recognized. According to the American Cancer Society, it and “other health organizations, and ovarian cancer advocacy groups encourage additional research to develop an accurate and valid test for early detection of ovarian cancer”.
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Results of Operations
Revenues
We have not earned any revenue from operations since our inception and further losses are anticipated in the development of our business. We are currently in the development stage of our business and we can provide no assurances that we will generate revenue in the foreseeable future.
Expenses
For the three and nine months ended September 30, 2014 and 2013, we incurred the following general and administrative expenses:
Three months | Three months | Nine months | Nine months | |||||||||
ended | ended | ended | ended | |||||||||
September 30, | September 30, | September 30, | September | |||||||||
2014 | 2013 | 2014 | 30, 2013 | |||||||||
General and Administrative Expenses | $ | $ | $ | $ | ||||||||
Accounting Fees | 6,000 | 6,000 | 18,000 | 18,000 | ||||||||
Audit & Tax Fees | 6,625 | 4,035 | 41,835 | 25,735 | ||||||||
Bank Fees | 126 | 81 | 486 | 376 | ||||||||
Consulting Fees | 135,803 | 146,353 | 423,977 | 431,977 | ||||||||
Filing and Transfer Agent Fees | 1,678 | 655 | 8,319 | 6,957 | ||||||||
Legal Fees | (786 | ) | 14,993 | 19,762 | 83,899 | |||||||
Travel Expenses | 1,944 | - | 7,583 | 3,754 | ||||||||
Office and Miscellaneous Expense | 1,751 | 1,677 | 7,493 | 4,288 | ||||||||
Research and Development Expense | 117,138 | 55,126 | 329,551 | 84,387 | ||||||||
Marketing Expense | (10 | ) | 10,318 | 512 | 86,496 | |||||||
Insurance Expense | 4,347 | - | 44,254 | 23,308 | ||||||||
Stock-Based Compensation | 3,479 | (7,626 | ) | 11,813 | 1,998 | |||||||
Meals & Entertainment Expenses | 68 | - | 420 | 238 | ||||||||
278,163 | 231,612 | 914,005 | 771,413 |
Our expenses increased by 20% during the three months ended September 30, 2014 compared to the same period in 2013 primarily due to an increase inresearch and development initiatives as we commenced clinical testing in connection with a variety of cancers.
Furthermore, our expenses increased by 18% during the nine months ended September 30, 2014 compared to the same period in 2013 as a result of the clinical testing that increased our overall research and development expenses.
Liquidity And Capital Resources
Working Capital
September 30, 2014 | December 31, 2013 | |
Total Current Assets | $593,460 | $862,695 |
Total Current Liabilities | $835,207 | $535,450 |
Working Capital (Deficiency) | $(241,747) | $327,245 |
Our working capital decreased because the funds required for operations have exceeded the incremental proceeds realized by Savicell upon the issuance of equity.
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Cash Flows
Nine months ended | Nine months ended | |||||
September 30, 2014 | September 30, 2013 | |||||
Net Cash (Used in) Operating Activities | $ | (581,775 | ) | $ | (749,620 | ) |
Net Cash Provided by Financing Activities | $ | 310,977 | $ | 1,244,822 | ||
Net Cash Provided by (Used in) Investing Activities | $ | - | $ | - |
Cash (Used in) Operating Activities
The decrease in cash used in operating activities compared to the same period last year is because of the fact that our employees and consultants have effectively financed a significant part of our operations by receiving only a portion of their contractual compensation.
Cash Provided by Financing Activities
The decrease in cash provided by financing activities compared to the same period last year results from a slower pace of equity issuances by Savicell within the current fiscal year.
Plan of Operation
We are an early-stage company. There exists substantial doubt that we can continue as an on-going business for the next 12 months unless we obtain additional capital to pay our expenses. This is because we have not generated any revenues and no material revenues are anticipated until we further develop our business. There is no assurance we will reach this point.
Our primary objectives for the next 12 month period are to further develop the Technology, to prove its efficiency via the ongoing clinical testing and to begin to consider a plan of commercialization.
We estimate our operating expenses and working capital requirements for the next 12 months to be as follows:
Expense | Amount | ||
Product development | $ | 800,000 | |
Employee and consultant compensation | 650,000 | ||
General and administration | 80,000 | ||
Professional services fees | 120,000 | ||
Regulation and compliance | 50,000 | ||
Sales, Marketing and Business development | 80,000 | ||
Total: | $ | 1,780,000 |
If we are not able to obtain the additional financing on a timely basis, if and when it is needed, we may be forced to cease the operation of our business.
Going Concern
The financial statements accompanying this report have been prepared on a going concern basis, which implies that our company will continue to realize its assets and discharge its liabilities and commitments in the normal course of business. Our company has not generated revenues since inception and has never paid any dividends and is unlikely to pay dividends or generate earnings in the immediate or foreseeable future. The continuation of our company as a going concern is dependent upon the continued financial support from our shareholders, the ability of our company to obtain necessary equity financing to achieve our operating objectives, and the attainment of profitable operations. As at September 30, 2014, our company has accumulated deficit of $5,701,566 since inception. We do not have sufficient working capital to enable us to carry out our stated plan of operation for the next 12 months.
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Due to the uncertainty of our ability to meet our current operating expenses and the capital expenses noted in their report on the financial statements for the year ended December 31, 2013, our independent auditors included an explanatory paragraph regarding concerns about our ability to continue as a going concern. Our financial statements contain additional note disclosures describing the circumstances that lead to this disclosure by our independent auditors.
The continuation of our business is dependent upon us raising additional financial support. The issuance of additional equity securities by us could result in a significant dilution in the equity interests of our current stockholders. Obtaining commercial loans, assuming those loans would be available, will increase our liabilities and future cash commitments.
Future Financings
We will require additional financing to fund our planned operations, including further development, clinical testing, regulatory requirements, and commercializing our existing assets. We currently do not have committed sources of additional financing and may not be able to obtain additional financing, particularly, if the volatile conditions in the stock and financial markets, and more particularly, the market for early development stage pharmaceutical company stocks persist.
There can be no assurance that additional financing will be available to us when needed or, if available, that it can be obtained on commercially reasonable terms. If we are not able to obtain the additional financing on a timely basis, if and when it is needed, we will be forced to delay or scale down some or all of our development activities or perhaps even cease the operation of our business.
Since inception we have funded our operations primarily through equity and debt financings and we expect that we will continue to fund our operations through the equity and debt financing. If we raise additional financing by issuing equity securities, our existing stockholders’ ownership will be diluted. Obtaining commercial loans, assuming those loans would be available, will increase our liabilities and future cash commitments.
There is no assurance that we will be able to maintain operations at a level sufficient for an investor to obtain a return on his, her, or its investment in our common stock. Further, we may continue to be unprofitable.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to stockholders.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not Applicable.
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ITEM 4. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under theSecurities Exchange Act of 1934 (the “Exchange Act”), are our controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Rules 13a-15(b) and 15d-15(b) under the Exchange Act, requires us to carry out an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of September 30, 2014. This evaluation was implemented under the supervision and with the participation of our Chief Executive Officer.
Based on this evaluation, management concluded that, as of September 30, 2014, our disclosure controls and procedures are not effective. The ineffectiveness of our disclosure controls and procedures was due to the existence of material weaknesses identified in our annual report on Form 10-K filed with the SEC on April 14, 2014.
Changes in Internal Control over Financial Reporting
During fiscal quarter ended September 30, 2014, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We know of no material pending legal proceedings to which our company or our subsidiary is a party or of which any of our properties, or the properties of our subsidiary, is the subject. In addition, we do not know of any such proceedings contemplated by any governmental authorities.
We know of no material proceedings in which any of our directors, officers or affiliates, or any registered or beneficial stockholder is a party adverse to our company or our subsidiary or has a material interest adverse to our company or our subsidiary.
ITEM 1A. RISK FACTORS
An investment in our common stock involves a number of very significant risks. You should carefully consider the following risks and uncertainties in addition to other information in this quarterly report on Form 10-Q in evaluating our company and our business before purchasing shares of our common stock. Our business, operating results and financial condition could be seriously harmed as a result of the occurrence of any of the following risks. You could lose all or part of your investment due to any of these risks. You should invest in our common stock only if you can afford to lose your entire investment.
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Risks Related to our Company
The worldwide economic downturn may reduce our ability to obtain the financing necessary to continue our business and may reduce the number of viable products and businesses that we may wish to acquire. If we cannot raise the funds that we need or find a suitable product or business to acquire, we may go out of business and investors will lose their entire investment in our company.
Since 2008, there has been a downturn in general worldwide economic conditions due to many factors, including the effects of the subprime lending and general credit market crises, slower economic activity, decreased consumer confidence, reduced corporate profits and capital spending, adverse business conditions, increased unemployment and liquidity concerns. In addition, these economic effects, including the resulting recession in various countries and slowing of the global economy, will likely result in fewer business opportunities as companies face increased financial hardship. Tightening credit and liquidity issues will also result in increased difficulties for our company to raise capital for our continued operations. We may not be able to raise money through the sale of our equity securities or through borrowing funds on terms we find acceptable. If we cannot raise the funds that we need or find a suitable product or business to acquire, we will go out of business. If we go out of business, investors will lose their entire investment in our company.
Our independent auditors have expressed substantial doubt about our ability to continue as a going concern.
We have not generated any revenue from operations since our incorporation. We expect that our operating expenses will increase over the next 12 months as we ramp-up our business. We estimate our average monthly expenses over the next 12 months to be approximately $77,000, including general and administrative expenses but excluding acquisition costs and the cost of any research expenditures and product development. In addition, we anticipate expending $800,000 in aggregate research and development and product development costs including in the context of our obligations pursuant to the License Agreement. On September 30, 2014, we had cash and cash equivalents of $580,989. As of September 30, 2014, we had total liabilities of approximately $835,207. If we are unable to meet our debt service obligations and other financial obligations, we could be forced to restructure or refinance, seek additional equity capital or sell our assets. We might then be unable to obtain such financing or capital or sell our assets on satisfactory terms.
We may need to raise additional funds in the future which may not be available on acceptable terms or at all.
We may consider issuing additional debt or equity securities in the future to fund potential acquisitions or investments, to refinance existing debt, or for general corporate purposes. If we issue equity or convertible debt securities to raise additional funds, our existing stockholders may experience dilution, and the new equity or debt securities may have rights, preferences and privileges senior to those of our existing stockholders. If we incur additional debt, it may increase our leverage relative to our earnings or to our equity capitalization, requiring us to pay additional interest expenses. We may not be able to market such issuances on favorable terms, or at all, in which case, we may not be able to develop or enhance our products, execute our business plan, take advantage of future opportunities, or respond to competitive pressures or unanticipated customer requirements.
We are an early-stage company with a limited operating history, which may hinder our ability to successfully meet our objectives.
We are an early-stage company with only a limited operating history upon which to base an evaluation of our current business and future prospects. As a result, the revenue and income potential of our business is unproven. In addition, because of our limited operating history, we have limited insight into trends that may emerge and affect our business. Errors may be made in predicting and reacting to relevant business trends and we will be subject to the risks, uncertainties and difficulties frequently encountered by early-stage companies in evolving markets. We may not be able to successfully address any or all of these risks and uncertainties. Failure to adequately do so could cause our business, results of operations and financial condition to suffer.
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Because our directors and officers are not all residents of the United States, investors may find it difficult to enforce, within the United States, any judgments obtained against our directors and officers.
Our directors and officer are not all residents of the United States, and all or a substantial portion of their assets are located outside the United States. As a result, it may be difficult for investors to enforce within the United States any judgments obtained against our directors and officers, including judgments predicated upon the civil liability provisions of the securities laws of the United States or any state thereof.
If we are unable to successfully recruit and retain qualified personnel, we may not be able to continue our operations.
In order to successfully implement and manage our business plan, we will depend upon, among other things, successfully recruiting and retaining qualified personnel having experience in the pharmaceutical industry. Competition for qualified individuals is intense. We may not be able to find, attract and retain qualified personnel on acceptable terms. If we are unable to find, attract and retain qualified personnel with technical expertise, our business operations could suffer.
Future growth could strain our resources, and if we are unable to manage our growth, we may not be able to successfully implement our business plan.
We hope to experience rapid growth in our operations, which will place a significant strain on our management, administrative, operational and financial infrastructure. Our future success will depend in part upon the ability of our executive officers to manage growth effectively. This will require that we hire and train additional personnel to manage our expanding operations. In addition, we must continue to improve our operational, financial and management controls and our reporting systems and procedures. If we fail to successfully manage our growth, we may be unable to execute upon our business plan.
Risks Relating to our Operations in Israel
Conditions in Israel and the surrounding Middle East may materially adversely affect our Subsidiary’s operations and personnel.
Our Subsidiary has significant operations in Israel, including research and development. Since the establishment of the State of Israel in 1948, a number of armed conflicts and terrorist acts have taken place, which in the past, and may in the future, lead to security and economic problems for Israel. In addition, certain countries in the Middle East adjacent to Israel, including Egypt and Syria, recently experienced and some continue to experience political unrest and instability marked by civil demonstrations and violence, which in some cases resulted in the replacement of governments and regimes. Current and future conflicts and political, economic and/or military conditions in Israel and the Middle East region may affect our operations in Israel. The exacerbation of violence within Israel or the outbreak of violent conflicts involving Israel may impede our Subsidiary’s ability to engage in research and development, or otherwise adversely affect its business or operations. In addition, our Subsidiary’s employees in Israel may be required to perform annual mandatory military service and are subject to being called to active duty at any time under emergency circumstances. The absence of these employees may have an adverse effect on our Subsidiary’s operations. Hostilities involving Israel may also result in the interruption or curtailment of trade between Israel and its trading partners, which could materially adversely affect our results of operations.
The ability of our Subsidiary to pay dividends is subject to limitations under Israeli law and dividends paid and loans extended by our Subsidiary may be subject to taxes.
The ability of our Subsidiary to pay dividends is governed by Israeli law, which provides that dividends may be paid by an Israeli corporation only out of its earnings as defined in accordance with the Israeli Companies Law of 1999, provided that there is no reasonable concern that such payment will cause such subsidiary to fail to meet its current and expected liabilities as they come due. Cash dividends paid by an Israeli corporation to United States resident corporate parents are subject to provisions of the Convention for the Avoidance of Double Taxation between Israel and the United States, which may result in our Subsidiary having to pay taxes on any dividends it declares.
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Risks Relating to the Pharmaceutical Business
If we are unable to successfully acquire, develop or commercialize new products, our operating results will suffer.
Our future results of operations will depend to a significant extent upon our ability to successfully develop and commercialize new products and businesses in a timely manner. There are numerous difficulties in, developing and commercializing new products, including:
• | there are still major developmental steps required to bring the product to a clinical testing stage; |
• | clinical testing may not be positive; |
• | developing, testing and manufacturing products in compliance with regulatory standards in a timely manner; |
• | failure to receive requisite regulatory approvals for such products in a timely manner or at all; |
• | developing and commercializing a new product is time consuming, costly and subject to numerous factors, including legal actions brought by our competitors, that may delay or prevent the development and commercialization of new products; |
• | incomplete, unconvincing or equivocal clinical trials data; |
• | experiencing delays or unanticipated costs; |
• | significant and unpredictable changes in the payer landscape, coverage and reimbursement for our products; |
• | experiencing delays as a result of limited resources at regulatory agencies; and |
• | changing review and approval policies and standards at regulatory agencies. |
As a result of these and other difficulties, products in development by us may or may not receive timely regulatory approvals, or approvals at all, necessary for marketing by us or other third-party partners. If any of our products are not approved in a timely fashion or, when acquired or developed and approved, cannot be successfully manufactured, commercialized or reimbursed, our operating results could be adversely affected. We cannot guarantee that any investment we make in developing products will be recouped, even if we are successful in commercializing those products.
Our expenditures may not result in commercially successful products.
We cannot be sure our business expenditures will result in the successful acquisition, development or launch of products that will prove to be commercially successful or will improve the long-term profitability of our business. If such business expenditures do not result in successful acquisition, development or launch of commercially successful brand products our results of operations and financial condition could be materially adversely affected.
Third parties may claim that we infringe their proprietary rights and may prevent us from manufacturing and selling some of our products.
The manufacture, use and sale of new products that are the subject of conflicting patent rights have been the subject of substantial litigation in the pharmaceutical industry. These lawsuits relate to the validity and infringement of patents or proprietary rights of third parties. Litigation may be costly and time-consuming, and could divert the attention of our management and technical personnel. In addition, if we infringe on the rights of others, we could lose our right to develop, manufacture or market products or could be required to pay monetary damages or royalties to license proprietary rights from third parties. Although the parties to patent and intellectual property disputes in the pharmaceutical industry have often settled their disputes through licensing or similar arrangements, the costs associated with these arrangements may be substantial and could include ongoing royalties. Furthermore, we cannot be certain that the necessary licenses would be available to us on commercially reasonable terms, or at all. As a result, an adverse determination in a judicial or administrative proceeding or failure to obtain necessary licenses could prevent us from manufacturing and selling our products, and could have a material adverse effect on our business, results of operations, financial condition and cash flows.
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Extensive industry regulation has had, and will continue to have, a significant impact on our business, especially our product development, manufacturing and distribution capabilities.
All pharmaceutical companies are subject to extensive, complex, costly and evolving government regulation. For the U.S., this is principally administered by the FDA and to a lesser extent by the DEA and state government agencies, as well as by varying regulatory agencies in foreign countries where products or product candidates are being manufactured and/or marketed. The Federal Food, Drug and Cosmetic Act, the Controlled Substances Act and other federal statutes and regulations, and similar foreign statutes and regulations, govern or influence the testing, manufacturing, packing, labeling, storing, record keeping, safety, approval, advertising, promotion, sale and distribution of our products.
Under these regulations, we may become subject to periodic inspection of our facilities, procedures and operations and/or the testing of our products by the FDA, the DEA and other authorities, which conduct periodic inspections to confirm that we are in compliance with all applicable regulations. In addition, the FDA and foreign regulatory agencies conduct pre-approval and post-approval reviews and plant inspections to determine whether our systems and processes are in compliance with GMP and other regulations. Following such inspections, the FDA or other agency may issue observations, notices, citations and/or warning letters that could cause us to modify certain activities identified during the inspection. FDA guidelines specify that a warning letter is issued only for violations of “regulatory significance” for which the failure to adequately and promptly achieve correction may be expected to result in an enforcement action. We may also be required to report adverse events associated with our products to the FDA and other regulatory authorities. Unexpected or serious health or safety concerns would result in labeling changes, recalls, market withdrawals or other regulatory actions.
The range of possible sanctions includes, among others, FDA issuance of adverse publicity, product recalls or seizures, fines, total or partial suspension of production and/or distribution, suspension of the FDA’s review of product applications, enforcement actions, injunctions, and civil or criminal prosecution. Any such sanctions, if imposed, could have a material adverse effect on our business, operating results, financial condition and cash flows. Under certain circumstances, the FDA also has the authority to revoke previously granted drug approvals. Similar sanctions as detailed above may be available to the FDA under a consent decree, depending upon the actual terms of such decree. If internal compliance programs do not meet regulatory agency standards or if compliance is deemed deficient in any significant way, it could materially harm our business.
The product would be licensed for sale in the EU through an EC certification process, frequently shorthanded as “CE Mark” under the IVDD 98/79/EC. It is possible that general controls are sufficient and a conformity assessment of a QMS would be sufficient to support clinical testing in the EU. If a Notified Body must be used, the CE Marking process has two stages: a certification of the manufacturer’s QMS (ability to safely develop devices) and the certification of the device performance and safety itself. Regulatory approval may be delayed, limited or denied for a number of reasons, including insufficient clinical data, the product not meeting safety or efficacy requirements or any relevant manufacturing processes or facilities not meeting applicable requirements.
Further trials and other costly and time-consuming assessments of the product may be required to obtain or maintain regulatory approval. We may be required to conduct additional trials beyond those currently planned, which could require significant time and expense.
The diagnostic industry is highly competitive.
The diagnostic industry has an intensely competitive environment that will require an ongoing, extensive search for technological innovations and the ability to market products effectively, including the ability to communicate the effectiveness, safety and value of products to healthcare professionals in private practice, group practices and payers in managed care organizations, group purchasing organizations and Medicare & Medicaid services. We are smaller than almost all of our competitors. Most of our competitors have been in business for a longer period of time than us, have a greater number of products on the market and have greater financial and other resources than we do. Furthermore, recent trends in this industry are toward further market consolidation of large drug companies into a smaller number of very large entities, further concentrating financial, technical and market strength and increasing competitive pressure in the industry. If we directly compete with them for the same markets and/or products, their financial strength could prevent us from capturing a profitable share of those markets. It is possible that developments by our competitors will make any products or technologies that we acquire non-competitive or obsolete.
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Even if our product candidates receive regulatory approval, they may still face future development and regulatory difficulties.
Even if U.S. regulatory approval or clearance is obtained, the FDA can impose significant restrictions on a product’s indicated uses or marketing or may impose ongoing requirements for potentially costly post-approval studies. Any of these restrictions or requirements could adversely affect our potential product revenues. Our product candidates will also be subject to ongoing FDA requirements for the labeling, packaging, storage, advertising, promotion, record-keeping and submission of safety and other post-market information on the drug. In addition, approved products, manufacturers and manufacturers’ facilities are subject to continual review and periodic inspections. If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product or us, including requiring withdrawal of the product from the market. If our product candidates fail to comply with applicable regulatory requirements, such as current Good Manufacturing Practices, or “CGMPs”, a regulatory agency may:
• | issue warning letters or untitled letters; |
• | require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific actions and penalties for noncompliance; |
• | impose other civil or criminal penalties; |
• | suspend regulatory approval; |
• | suspend any ongoing clinical trials; |
• | refuse to approve pending applications or supplements to approved applications filed by us; |
• | impose restrictions on operations, including costly new manufacturing requirements; or |
• | seize or detain products or require a product recall. |
Our commercialization efforts will be greatly dependent upon our ability to demonstrate product efficacy in clinical trials. Laboratories will be reluctant to order our products, and medical practitioners will be reluctant to prescribe our products, without compelling supporting data. The failure to demonstrate efficacy in our clinical trials, or a delay or failure to complete our clinical trials, would have a material adverse effect on our business, prospects, financial condition and operating results.
Our failure to convince medical practitioners to use our technologies will limit our revenue and profitability.
If we, or our commercialization partners, fail to convince medical practitioners to prescribe products using our technologies, we will not be able to sell our products or license our technologies in sufficient volume for our business to become profitable. We will need to make leading physicians aware of the benefits of products using our technologies through published papers, presentations at scientific conferences and favorable results from our clinical studies. Our failure to be successful in these efforts would make it difficult for us to convince medical practitioners to prescribe products using our technologies for their patients. Failure to convince medical practitioners to prescribe our products will damage our commercialization efforts and would have a material adverse effect on our business, prospects, financial condition and operating results.
We may not be able to market or generate sales of our products to the extent anticipated.
Assuming that we are successful in receiving regulatory clearances to market any of our products, our ability to successfully penetrate the market and generate sales of those products may be limited by a number of factors, including the following:
• | Certain of our competitors in the field have already received regulatory approvals for and have begun marketing similar products, which may result in greater physician awareness of their products as compared to ours; |
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• | Information from our competitors or the academic community indicating that current products or new products are more effective than our products could, if and when it is generated, impede our market penetration or decrease our existing market share; |
• | The price for our products, as well as pricing decisions by our competitors, may have an effect on our revenues; and |
• | Our revenues may diminish if third-party payers, including private health coverage insurers and health maintenance organizations, do not provide adequate coverage or reimbursement for our products. |
If any of our future marketed products were to experience problems related to their efficacy, safety, or otherwise, or if new, more effective treatments were to be introduced, our revenues from such marketed products could decrease.
If any of our current or future marketed products become the subject of problems, including those related to, among others:
• | efficacy or safety concerns with the products, even if not justified; |
• | regulatory proceedings subjecting the products to potential recall; |
• | publicity affecting doctor prescription or patient use of the product; |
• | pressure from competitive products; or |
• | introduction of more effective tests. |
Our revenues from such marketed products could decrease. For example, efficacy or safety concerns may arise, whether or not justified, that could lead to the recall or withdrawal of such marketed products. In the event of a recall or withdrawal of a product, our revenues would significantly decline.
Risks Relating to our Common Stock
If we issue additional shares in the future, it will result in the dilution of our existing shareholders.
Our articles of incorporation authorize the issuance of up to 500,000,000 shares of common stock with a par value of $0.001 per share and 20,000,000 shares of preferred stock with a par value of $0.001 per share. Our board of directors may choose to issue some or all of such shares to acquire one or more companies or products and to fund our overhead and general operating requirements. The issuance of any such shares will reduce the book value per share and may contribute to a reduction in the market price of the outstanding shares of our common stock. If we issue any such additional shares, such issuance will reduce the proportionate ownership and voting power of all current shareholders. Further, such issuance may result in a change of control of our corporation.
Trading of our stock is restricted by the Securities Exchange Commission’s penny stock regulations, which may limit a stockholder’s ability to buy and sell our common stock.
The Securities and Exchange Commission has adopted regulations which generally define “penny stock” to be any equity security that has a market price (as defined) less than $5.00 per share or an exercise price of less than $5.00 per share, subject to certain exceptions. Our securities are covered by the penny stock rules, which impose additional sales practice requirements on broker-dealers who sell to persons other than established customers and “accredited investors”. The term “accredited investor” refers generally to institutions with assets in excess of $5,000,000 or individuals with a net worth in excess of $1,000,000 or annual income exceeding $200,000 or $300,000 jointly with their spouse. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document in a form prepared by the Securities and Exchange Commission, which provides information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer also must provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson in the transaction and monthly account statements showing the market value of each penny stock held in the customer’s account. The bid and offer quotations, and the broker-dealer and salesperson compensation information, must be given to the customer orally or in writing prior to effecting the transaction and must be given to the customer in writing before or with the customer’s confirmation. In addition, the penny stock rules require that prior to a transaction in a penny stock not otherwise exempt from these rules; the broker-dealer must make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. These disclosure requirements may have the effect of reducing the level of trading activity in the secondary market for the stock that is subject to these penny stock rules. Consequently, these penny stock rules may affect the ability of broker-dealers to trade our securities. We believe that the penny stock rules discourage investor interest in and limit the marketability of our common stock.
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FINRA sales practice requirements may also limit a stockholder’s ability to buy and sell our stock.
In addition to the “penny stock” rules described above, the Financial Industry Regulatory Authority (known as “FINRA”) has adopted rules that require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending speculative low priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information. Under interpretations of these rules, FINRA believes that there is a high probability that speculative low priced securities will not be suitable for at least some customers. FINRA requirements make it more difficult for broker-dealers to recommend that their customers buy our common stock, which may limit your ability to buy and sell our stock and have an adverse effect on the market for our shares.
Our common stock is illiquid and the price of our common stock may be negatively impacted by factors which are unrelated to our operations.
Although our common stock is currently listed for quotation on the OTC Bulletin Board, there is no market for our common stock. Even when a market is established and trading begins, trading through the OTC Bulletin Board is frequently thin and highly volatile. There is no assurance that a sufficient market will develop in our stock, in which case it could be difficult for shareholders to sell their stock. The market price of our common stock could fluctuate substantially due to a variety of factors, including market perception of our ability to achieve our planned growth, quarterly operating results of our competitors, trading volume in our common stock, changes in general conditions in the economy and the financial markets or other developments affecting our competitors or us. In addition, the stock market is subject to extreme price and volume fluctuations. This volatility has had a significant effect on the market price of securities issued by many companies for reasons unrelated to their operating performance and could have the same effect on our common stock.
We do not intend to pay dividends on any investment in the shares of stock of our company.
We have never paid any cash dividends and currently do not intend to pay any dividends for the foreseeable future. Because we do not intend to declare dividends, any gain on an investment in our company will need to come through an increase in the stock’s price. This may never happen and investors may lose all of their investment in our company.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Since the beginning of the three month period ended September 30, 2014, we have not sold any equity securities that were not registered under theSecurities Act of 1933 that were not previously reported in an annual report on Form 10-K, in a quarterly report on Form 10-Q or in a current report on Form 8-K.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5. OTHER INFORMATION
None.
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ITEM 6. EXHIBITS
Exhibit Number |
|
(2) | Plan of acquisition, reorganization, arrangement, liquidation or succession |
2.1 | License and Research Funding Agreement dated July 25, 2012 between Ramot at Tel Aviv University Ltd. and Savicell Diagnostic Ltd.(portions of the exhibit has been omitted pursuant to a requestfor confidential treatment)(incorporated by reference to an exhibit to a current report on Form 8 -K filed July 16, 2013) |
(3) | Articles of Incorporation and Bylaws |
3.1 | Articles of Incorporation (incorporated by reference to an exhibit to a registration statement on Form S-1 filed on August 10, 2010) |
3.2 | Bylaws (incorporated by reference to an exhibit to a registration statement on Form S-1 filed on August 10, 2010) |
(10) | Material Contracts |
10.1 | Consulting Agreement dated November 1, 2011 with 1367826 Ontario Limited and Robbie Manis (incorporated by reference to an exhibit to a current report on Form 8-K filed on November 3, 2011) |
10.2 | Consulting Agreement dated November 1, 2011 with Kerry Chow (incorporated by reference to an exhibit to a current report on Form 8-K filed on November 3, 2011) |
10.3 | Loan Terms Agreement dated November 4, 2011 with Peter Hough (incorporated by reference to an exhibit to a current report on Form 8-K filed on November 8, 2011) |
10.4 | Mineral Property Acquisition Agreement dated November 21, 2011 with Minera Del Pacifico, S.A. (incorporated by reference to an exhibit to a current report on Form 8-K filed November 21, 2011) |
10.5 | Loan Terms Agreement dated November 24, 2011 with Amir Rachmani (incorporated by reference to an exhibit to a current report on Form 8-K filed November 24, 2011) |
10.6 | Loan Terms Agreement dated February 13, 2012 with Ori Ackerman (incorporated by reference to an exhibit to a current report on Form 8-K filed February 13, 2012) |
10.7 | Form of Subscription Agreement for Non-US Subscribers (incorporated by reference to an exhibit to a current report on Form 8-K filed May 24, 2012) |
10.8 | Form of Subscription Agreement for US Subscribers (incorporated by reference to an exhibit to a current report on Form 8-K filed May 24, 2012) |
10.9 | Form of Shares for Debt Agreement for Canadian Subscribers (incorporated by reference to an exhibit to a current report on Form 8-K filed July 18, 2012) |
10.10 | Form of Subscription Agreement for Non-US Subscribers (incorporated by reference to an exhibit to a current report on Form 8-K filed July 18, 2012) |
10.11 | Warrant Agreement dated July 25, 2012 between Savicell Diagnostic Ltd. and Ramot at Tel Aviv University Ltd. (incorporated by reference to an exhibit to a current report on Form 8-K filed August 19, 2013) |
10.12 | Employment Agreement with Giora Davidovits dated September 1, 2012 (incorporated by reference to an exhibit to a current report on Form 8-K filed September 19, 2012) |
10.13 | Form of Conversion and Participation Rights Agreement (incorporated by reference to an exhibit to a current report on Form 8-K filed November 1, 2012) |
10.14 | Employment Agreement with Eyal Davidovits dated October 30, 2012 (incorporated by reference to an exhibit to a current report on Form 8-K filed November 5, 2012) |
10.15 | Form of Debt Conversion Agreement (incorporated by reference to an exhibit to a current report on Form 8-K filed November 16, 2012) |
10.16 | Form of Offshore Debt Conversion Agreement (incorporated by reference to an exhibit to a current report on Form 8-K filed November 16, 2012) |
10.17 | Form of Canadian Debt Conversion Agreement (incorporated by reference to an exhibit to a current report on Form 8-K filed November 16, 2012) |
(21) | Subsidiaries |
21.1 | Savicell Diagnostic Ltd. our approximately 75.88% subsidiary incorporated in Israel on April 23, 2012 |
21.2 | Savicell Ltd. |
(33) | Certification |
31.1* | Section 302 of the Sarbanes-Oxley Act of 2002 of Giora Davidovits |
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*Filed herewith.
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SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
ONLINE DISRUPTIVE TECHNOLOGIES, INC. |
By |
/s/ Giora Davidovits |
Giora Davidovits |
Chief Executive Officer, Chief Financial Officer, |
President, Secretary, Treasurer and Director |
(Principal Executive Officer, Principal Financial Officer and Principal Accounting Officer) |
November 13, 2014 |