OPIANT PHARMACEUTICALS, INC. - Quarter Report: 2010 October (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended October 31, 2010
or
o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from __________________ to _________________
Commission file number 333-139915
LIGHTLAKE THERAPEUTICS INC.
(Exact name of registrant as specified in its charter)
Nevada
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N/A
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(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.)
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54 Baker Street., 6th Floor
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W1U 7BU
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(Address of principal executive offices)
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(Zip Code)
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44-207-034-1943
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(Registrant’s telephone number, including area code)
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(Former name, former address and former fiscal year, if changed since last report)
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the 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
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x
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No
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o
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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 the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
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o
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Accelerated filer
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o
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Non-accelerated filer
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o
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(Do not check if a smaller reporting company)
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Smaller reporting company
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x
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes
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o
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No
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x
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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 Sections 12, 13 or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.
Yes
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o
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No
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o
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APPLICABLE ONLY TO CORPORATE ISSUERS
There were 61,788,333 shares of Common Stock outstanding as of October 31, 2010.
TABLE OF CONTENTS
PART I — FINANCIAL INFORMATION
Item 1. Financial Statements.
Lightlake Therapeutics, Inc.
(formerly known as Madrona Ventures, Inc.)
( a Development Stage Enterprise)
October 31,
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July 31,
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Assets
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2010
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2010
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Current assets
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Cash and cash equivalents
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$ | 2,300 | $ | 2,300 | ||||
Other current assets
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- | - | ||||||
Total current assets
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2,300 | 2,300 | ||||||
Other assets
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Patent and patent applications (net of accumulated amortization)
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19,571 | 19,825 | ||||||
Total assets
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$ | 21,871 | $ | 22,125 | ||||
Liabilities and Shareholders' Deficit
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Liabilities
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Accounts payable and accrued liabilities
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$ | 233,908 | $ | 203,908 | ||||
Accrued salaries and wages
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92,417 | $ | 74,917 | |||||
Due to related party
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572,587 | 380,587 | ||||||
Total liabilities
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898,912 | 659,412 | ||||||
Stockholders' equity (deficit)
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Common stock; par value $0.001; 200,000,000 shares authorized;
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61,788,333 shares issued and outstanding at October 31, 2010 and
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61,508,333 shares issued and outstanding at July 31, 2010
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61,788 | 61,508 | ||||||
Additional paid-in capital
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1,414,845 | 1,373,125 | ||||||
Accumulated deficit during the development stage
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(2,353,674 | ) | (2,071,920 | ) | ||||
Total stockholders' equity (deficit)
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(877,041 | ) | (637,287 | ) | ||||
Total liabilities and stockholders' equity
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$ | 21,871 | $ | 22,125 |
The accompanying notes are an integral part of these financial statements.
Lightlake Therapeutics, Inc.
(formerly known as Madrona Ventures, Inc.)
(a Development Stage Enterprise)
Statements of Operations
For the three months ended October 31, 2010 and 2009 and
the period from Inception (June 21, 2005) to October 31, 2010
For the |
From Inception
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Three Months Ended
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(June 21, 2005)
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October 31,
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to October 31,
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2010
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2009
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2010
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Revenues
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$ | - | $ | - | $ | - | ||||||
Operating expenses
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General and administrative
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281,754 | 76,214 | 2,357,822 | |||||||||
Mineral interests
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- | - | 39,015 | |||||||||
Total operating expenses
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281,754 | 76,214 | 2,396,837 | |||||||||
Income (loss) from operations
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(281,754 | ) | (76,214 | ) | (2,396,837 | ) | ||||||
Other income (expense)
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Debt forgiveness
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- | - | 43,163 | |||||||||
Total other income (expense)
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- | - | 43,163 | |||||||||
Income (loss) before provision for income taxes
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(281,754 | ) | (76,214 | ) | (2,353,674 | ) | ||||||
Provision for income taxes
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- | - | - | |||||||||
Net income (loss)
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$ | (281,754 | ) | $ | (76,214 | ) | $ | (2,353,674 | ) | |||
Basic and fully diluted loss per common share:
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Earnings (loss) per common share
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$ | (0.00 | ) | $ | (0.00 | ) | ||||||
Basic and fully diluted weighted average
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||||||||||||
common shares outstanding
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61,578,333 | 94,449,311 |
The accompanying notes are an integral part of these financial statements.
Lightlake Therapeutics, Inc.
(formerly known as Madrona Ventures, Inc.)
( a Development Stage Enterprise)
Statement of Stockholders' Equity (Deficit)
For the period from Inception (June 21, 2005)
to October 31, 2010
Deficit
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Additional
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During the
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Common Stock
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Paid In
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Treasury
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Development |
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Shares
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Amount
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Capital
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Stock
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Stage
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Total
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Balance at June 21, 2005
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- | $ | - | $ | - | $ | - | $ | - | $ | - | |||||||||||||
Balance at July 31, 2005
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- | - | - | - | - | - | ||||||||||||||||||
Common shares issued for cash
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March 2006 at $0.001 per share
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5,000,000 | 5,000 | - | 5,000 | ||||||||||||||||||||
March 2006 at $0.01 per share
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1,300,000 | 1,300 | 11,700 | 13,000 | ||||||||||||||||||||
April 2006 at $0.01 per share
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75,000 | 75 | 7,425 | 7,500 | ||||||||||||||||||||
May 2006 at $0.01 per share
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150,000 | 150 | 29,850 | 30,000 | ||||||||||||||||||||
Net income (loss)
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(32,125 | ) | (32,125 | ) | ||||||||||||||||||||
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Balance at July 31, 2006
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6,525,000 | 6,525 | 48,975 | - | (32,125 | ) | 23,375 | |||||||||||||||||
Net income (loss)
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(33,605 | ) | (33,605 | ) | ||||||||||||||||||||
Balance at July 31, 2007
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6,525,000 | 6,525 | 48,975 | - | (65,730 | ) | (10,230 | ) | ||||||||||||||||
Net income (loss)
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(17,924 | ) | (17,924 | ) | ||||||||||||||||||||
Balance at July 31, 2008
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6,525,000 | 6,525 | 48,975 | - | (83,654 | ) | (28,154 | ) | ||||||||||||||||
Net income (loss)
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- | - | - | - | 28,444 | 28,444 | ||||||||||||||||||
Balance at July 31, 2009
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6,525,000 | $ | 6,525 | $ | 48,975 | $ | - | $ | (55,210 | ) | $ | 290 | ||||||||||||
Forward Stock Split : 20 for 1
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130,500,000 | $ | 130,500 | $ | (130,500 | ) | - | |||||||||||||||||
Stock Issued for Acquisition of Patent
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20,333,333 | 20,333 | - | - | 20,333 | |||||||||||||||||||
Cancellation of Shares
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(100,000,000 | ) | (100,000 | ) | 100,000 | - | - | |||||||||||||||||
Stock for services
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4,150,000 | 4,150 | 1,354,650 | 1,358,800 | ||||||||||||||||||||
Net income (loss)
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(2,016,710 | ) | (2,016,710 | ) | ||||||||||||||||||||
Balance at July 31, 2010
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61,508,333 | $ | 61,508 | $ | 1,373,125 | $ | - | $ | (2,071,920 | ) | $ | (637,287 | ) | |||||||||||
October 6, 2010: Stock issued for services
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200,000 | 200 | 29,800 | 30,000 | ||||||||||||||||||||
October 13, 2010: Stock issued for services
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80,000 | 80 | 11,920 | 12,000 | ||||||||||||||||||||
Net income (loss)
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(281,754 | ) | (281,754 | ) | ||||||||||||||||||||
Balance at October 31, 2010
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61,588,333 | $ | 61,788 | $ | 1,414,845 | $ | - | $ | (2,353,674 | ) | $ | (625,287 | ) |
The accompanying notes are an integral part of these financial statements.
Lightlake Therapeutics, Inc.
(formerly known as Madrona Ventures, Inc.)
( a Development Stage Enterprise)
Statements of Cash Flows
For the Three Months Ended October 31, 2010 and 2009 and the period
From Inception (June 21, 2005) to October 31, 2010
For the |
From Inception
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Three Months Ended |
(June 21, 2005)
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October 31, |
to October 31,
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2010
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2009
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2010
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Cash Flows Provided (Used) By Operating Activities
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Net income (loss)
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$ | (281,754 | ) | $ | (76,214 | ) | $ | (2,353,674 | ) | |||
Adjustments to reconcile net income (loss) to net cash
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provided from (used by) operating activities:
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Amortization
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254 | - | 762 | |||||||||
Issuance of common stock for services
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42,000 | 300 | 1,400,800 | |||||||||
Increase (decrease) in accounts payable
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30,000 | 1,100 | 233,908 | |||||||||
Increase in accrued salaries and wages
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17,500 | 75,248 | 92,417 | |||||||||
Net cash provided from (used by) operating activities
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(192,000 | ) | 434 | (625,787 | ) | |||||||
Cash Flows Provided (Used) By Investing Activities
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- | - | - | |||||||||
Cash Flows Provided (Used) By Financing Activities
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Borrowings from related party
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192,000 | - | 572,587 | |||||||||
Issuance of common stock for cash
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- | - | 55,500 | |||||||||
Net cash provided from (used by) financing activities
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192,000 | - | 628,087 | |||||||||
Net increase (decrease) in cash and cash equivalents
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- | 434 | 2,300 | |||||||||
Cash and cash equivalents, beginning of period
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2,300 | 290 | - | |||||||||
Cash and cash equivalents, end of period
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$ | 2,300 | $ | 724 | $ | 2,300 | ||||||
Supplemental disclosure
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Interest paid during the period
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$ | - | $ | - | $ | - | ||||||
Non-Cash Transactions
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In August, 2009, the Company acquired a Patent and Patent Applications through the issuance of 20,333,000 Common shares.
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In December, 2009, the Company cancelled 100,000,000 shares of common stock.
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The accompanying notes are an integral part of these financial statements.
Lightlake Therapeutics, Inc.
(Formerly Known As Madrona Ventures, Inc.)
(a Development Stage Enterprise)
Notes to Financial Statements
For the three months ended October 31, 2010 and July 31, 2010
1. Organization, Description of Business, and Basis of Accounting
Business Organization
Lightlake Therapeutics, Inc., (formerly known as Madrona Ventures, Inc.) (the Company) was originally incorporated in the State of Nevada on June 21, 2005. On September 16, 2009, the Company changed its’ name to Lightlake Therapeutics, Inc. The Company’s fiscal year end is July 31. The company is currently in the development stage and to date its’ activities have been limited to capital formation. The Company is currently in the development stage and has limited assets and no revenue. In accordance with the FASB ASC 915, it is considered a Development Stage Company.
Accounting Basis
These financial statements have been prepared on the accrual basis of accounting following generally accepted accounting principles of the United States of America consistently applied.
Income Taxes
The Company uses the asset and liability method of accounting for income taxes. At October 31, 2010 and July 31, 2010, respectively, the deferred tax asset and deferred tax liability accounts, as recorded when material to the financial statements, are entirely the result of temporary differences. Temporary differences represent differences in the recognition of assets and liabilities for tax and financial reporting purposes, primarily share based compensation and loss on settlement of debt.
As of October 31, and July 31, 2010, the deferred tax asset related to the Company's net operating loss (NOL) carryforward is fully reserved. Due to the provisions of Internal Revenue Code Section 338, the Company may have no net operating loss carryforwards available to offset financial statement or tax return taxable income in future periods as a result of a change in control involving 50 percentage points or more of the issued and outstanding securities of the Company.
Dividends
The Company is a Development Stage Company and has not yet adopted a policy regarding the payment of dividends.
Earnings (Loss) per Share
Basic earnings (loss) per share is computed by dividing the net income (loss) available to common shareholders by the weighted-average number of common shares outstanding during the respective period presented in our accompanying financial statements.
Fully diluted earnings (loss) per share is computed similar to basic income (loss) per share except that the denominator is increased to include the number of common stock equivalents (primarily outstanding options and warrants).
Lightlake Therapeutics, Inc.
(Formerly Known As Madrona Ventures, Inc.)
(a Development Stage Enterprise)
Notes to Financial Statements
For the three months ended October 31, 2010 and July 31, 2010
1. Organization, Description of Business, and Basis of Accounting (Cont.)
Earnings (Loss) per Share (Cont.)
Common stock equivalents represent the dilutive effect of the assumed exercise of outstanding stock options and warrants, using the treasury stock method, at either the beginning of the respective period presented or the date of issuance, whichever is later, and only if the common stock equivalents are considered dilutive based upon the Company’s net income (loss) position at the calculation date.
As of October 31 and July 31, 2010, the Company’s has no issued and outstanding warrants or options.
Research and Development Costs
The Company expenses all research and development costs as incurred for which there is no alternative future use. These costs also include the expensing of employee compensation and employee stock based compensation.
Stock-Based Compensation
In December 2004, the FASB issued FASB Accounting Standards Codification No. 718, Compensation – Stock Compensation. Under FASB Accounting Standards Codification No. 718, companies are required to measure the compensation costs of share-based compensation arrangements based on the grant-date fair value and recognize the costs in the financial statements over the period during which employees are required to provide services. Share-based compensation arrangements include stock options, restricted share plans, performance-based awards, share appreciation rights and employee share purchase plans. As such, compensation cost is measured on the date of grant at their fair value. Such compensation amounts, if any, are amortized over the respective vesting periods of the option grant. The Company applies this statement prospectively.
The Company has not adopted a stock option plan and has not granted any stock options. Accordingly, no stock-based compensation has been recorded to date.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Lightlake Therapeutics, Inc.
(Formerly Known As Madrona Ventures, Inc.)
(a Development Stage Enterprise)
Notes to Financial Statements
For the three months ended October 31, 2010 and July 31, 2010
2. Going Concern
The accompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the liquidation of liabilities in the normal course of business. However, the Company has incurred significant losses and is dependent on obtaining adequate capital to fund operating losses until it becomes profitable. If the Company is unable to obtain the necessary funding it could cease operations as a new enterprise. This raises substantial doubt about the Company’s ability to continue as a going concern. These financial statements do not include any adjustments that might result from this uncertainty
3. Related Party Transactions
The Company’s Chief Financial Officer advanced funds to the Company for working capital needs in the amount of $572,587. The amounts were non-interest bearing, unsecured, with no stated terms or repayment.
Prior to fiscal 2009, and through the date of the Belmont Agreement (Note 6), a former officer of the Company advanced funds to the Company for working capital needs. The amounts were non-interest bearing, unsecured, with no stated terms or repayment. Concurrent with the Belmont Agreement, the former officer forgave the advances aggregating $28,816.
4. Income Taxes
The Company provides for income taxes asset and liability approach in accounting for income taxes. Deferred tax assets and liabilities are recorded based on the differences between the financial statement and tax bases of assets and liabilities and the tax rates in effect when these differences are expected to reverse. This method requires the reduction of deferred tax assets by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
The provision for income taxes differs from the amounts which would be provided by applying the statutory federal income tax rate to the net loss before provision for income taxes for the following reasons:
October 31, 2010
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July 31, 2010
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Income tax expense at statutory rate
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$ | (109,884 | ) | $ | (786,517 | ) | ||
Valuation allowance
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109,884 | 786,517 | ||||||
Income tax expense per books
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$ | - | $ | - |
Lightlake Therapeutics, Inc.
(Formerly Known As Madrona Ventures, Inc.)
(a Development Stage Enterprise)
Notes to Financial Statements
For the three months ended October 31, 2010 and July 31, 2010
4. Income Taxes (Cont.)
Net deferred tax assets consist of the following components as of:
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October 31, 2010
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July 31, 2010
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||||||
Net Operating Loss Carryover
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$ | (1,089,803 | ) | $ | (808,049 | ) | ||
Valuation allowance
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1,089,803 | 808,049 | ||||||
Net deferred tax asset
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$ | - | $ | - |
The Company has a net operating loss carryover of $2,353,674 as of October 31, 2010 which expires in 2026. Due to the change in ownership provisions of the Tax Reform Act of 1986, net operating loss carry forwards for federal income tax reporting purposes are subject to annual limitations. Should a change in ownership occur net operating loss carry forwards may be limited as to use in future years.
The Company has net operating loss carryforwards that were derived solely from operating losses from prior years. These amounts can be carried forward to offset future taxable income for a period of 20 years for each tax year’s loss. No provision was made for federal income taxes as the Company has significant net operating losses.
At October 31, and July 31, 2010, the Company has established a valuation allowance equal to the deferred tax assets as there is no assurance that the Company will generate future taxable income to utilize these assets.
Due to the provisions of Internal Revenue Code Section 338, the Company may have no net operating loss carryforwards available to offset financial statement or tax return taxable income in future periods as a result of a change in control involving 50 percentage points or more of the issued and outstanding securities of the Company. The Company had no uncertain tax positions at October 31 or July 31, 2010.
5. Patent and Patent Applications
On August 24, 2009, the Company acquired European Patent EP1681057B1 and U.S. Patent Application 11/031,534 through the issuance of 20,333,000 of its’ common stock. The company recorded the patents at $20,333, which approximated the fair market value. The costs associated with these patents are being depreciated on a straight line basis over a period of 20 years.
Lightlake Therapeutics, Inc.
(Formerly Known As Madrona Ventures, Inc.)
(a Development Stage Enterprise)
Notes to Financial Statements
For the three months ended October 31, 2010 and July 31, 2010
6. Captial Stock
The Company has 200,000,000 common shares authorized at a par value of $0.001. At October 31, and July 31, 2010 there were 61,788,333 and 61,508,333shares issued and outstanding, respectively. The Company has no other classes of shares authorized for issuance.
During the year ended July 31, 2010, the Company effectuated a 20 for 1 forward stock split. Subsequently, the Company’s chief executive officer cancelled 100,000,000 common shares beneficially owned by him through his ownership in Pelikin Group.
During the year ended July 31, 2010, the Company issued 4,150,000 common shares to various individuals and entities for services rendered to the Company. The aggregate value of the shares issued was $1,358,800 based on the closing price of the Company’s common stock at the date of issuance, which approximates the fair market value of the services rendered.
At October 31, 2010 and July 31, 2010, there were no outstanding stock options or warrants.
7. Common Stock Purchase Agreement
On June 26, 2009, the Company completed a common stock purchase agreement (the Belmont Agreement) whereby Belmont Partners, LLC acquired 5,000,000 common shares of the Company’s common stock. Following the transaction, Belmont Partners, LLC controlled approximately 76.6% of the Company’s outstanding capital stock. Concurrent with the agreement, Mr. Joseph Meuse, managing member of Belmont Partners, LLC, was named to the Board of Directors as well as President and Secretary of the Company, and the Company’s former officers resigned from all positions held in the Company.
In connection with the Belmont Agreement, the Company’s former officers forgave amounts advanced to the Company aggregating $28,816 as well as either paid or assumed the remaining other liabilities of the Company aggregating $14,347. Accordingly, the Company recorded a gain on debt extinguishment of $43,163.
On July 31, 2009, the Company completed a common stock purchase agreement (the Pelikin Agreement) whereby Pelikin Group acquired 5,000,000 common shares of the Company’s common stock from Belmont Partners. Following the transaction, Pelikin Group controls approximately 76.6% of the Company’s outstanding capital stock. Concurrent with the agreement, Mr. Sei Ki was named to the Board of Directors as well as President and Secretary of the Company, and Mr. Joseph Muese resigned from all positions held in the Company.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
FORWARD LOOKING STATEMENTS
Statements contained herein which are not historical facts are forward-looking statements as that term is defined by the Private Securities Litigation Reform Act of 1995. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, forward-looking statements are subject to risks and uncertainties that could cause actual results to differ from those projected. The Company cautions investors that any forward-looking statements made by the Company are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Such risks and uncertainties include without limitation: established competitors who have substantially greater financial resources and operating histories, regulatory delays or denials, ability to compete as a start-up company in a highly competitive market and access to sources of capital.
The following discussion and analysis should be read in conjunction with our financial statements and notes thereto included elsewhere in this form 10-Q. Except for the historical information contained herein, the discussion in this form 10-Q contains certain forward-looking statements that involve risk and uncertainties, such as statements of plans, objectives, expectations and intentions. The cautionary statements made in this form 10-Q should be read as being applicable to all related forward-looking statements wherever they appear in this form 10-Q. The Company's actual results could differ materially from those discussed here.
Lightlake Therapeutics, Inc. is an early stage biopharmaceutical company, currently developing a new approach for the treatment of overweight and obese patients with binge eating disorder. Our strategy is to build a specialist Biopharmaceutical Company based on our expertise using opioid antagonists.
The Company will conduct a Phase II clinical trial to investigate the use of intranasal naloxone for obese and overweight patients with binge eating. Our approach is unique, through using a single agent with known safety, delivered intra-nasally, in response to behavioral stimuli, and selectively addressing a subset of obese and overweight patients which is approximately 25% of all obese and overweight patients. We believe this approach will deliver successful outcomes in a challenging area that has recently encountered several failures.
We now aim to commence a six month randomized, double blind placebo controlled trial in Helsinki, Finland during the first quarter of 2011. It is our aim for this trial to be FDA compliant. We have identified a suitable nasal spray manufacturer, and patient selection for the Phase II trial is completed, with 298 candidates for the trial. A total of 138 individuals with the appropriate genetic marker will be recruited from this patient base.
If the outcome of Phase II is favorable, we aim to collaborate with other parties to progress and fund Phase III, which will be held at the Imperial College London, in the UK and other international institutions. We currently have such an agreement with Celesio AG and we will pursue similar relationships over the next twelve months. At this point the management team will be strengthened accordingly. During the next year we aim to broaden our product pipeline, and anticipate acquiring additional patents that relate to the use of opioid antagonists.
PLAN OF OPERATION
The Company was incorporated in the State of Nevada on June 21, 2005, as Madrona Ventures, Inc. and on September 16, 2009, the Company changed its’ name to Lightlake Therapeutics, Inc. The Company’s fiscal year end is July 31 and is a Development Stage Company. Lightlake Therapeutics Inc. is an early stage biopharmaceutical company, currently developing a new approach for the treatment of overweight and obese patients with binge eating disorder. Our strategy is to build a specialty Biopharmaceutical Company based on our expertise using opioid antagonists.
During the year ended July 31, 2010, the company carried out operations to exploit the patent and patent applications it acquired on August 24, 2009 the company acquired European Patent EP1681057B1 and U.S. Patent Application 11/031,534. The company was informed on Oct. 15, 2010, that the Examiner has approved the application and that the US Patent will be granted.
In November, 2009 the clinical trial team in Helsinki, Finland was granted ethical approval to begin screening subjects for a future Phase II clinical trial under the direction of its trial coordinator Professor Hannu Eero Rafael Alho, Professor of Addiction Medicine, University of Helsinki. The trial is being conducted in conjunction with the National Institute for Health and Welfare, in Helsinki, Finland. The screening has been completed for patient selection for the Phase II trial. A total of 900 people contacted Lightlake. Of these 298 have had gene samples analyzed, in preparation to the selection of the 138 subjects for the trial
The company on May 6, 2010, was granted ethical approval for the Phase II trial itself . It is to be held at the National Institute for Health and Welfare, in Helsinki, Finland. A preliminary meeting with the FIMEA Regulatory Authority was held on May 7 and their requirements for approval obtained.
Our plan of operation for the next twelve months is to pursue the Phase II clinical trials in Helsinki, Finland on the user patents that were acquired by the company from Dr. David Sinclair, in exchange for 20,333,333 restricted common shares on August 24, 2009. The safe and effective treatment is a proprietary patented pharmaceutical medicine-based program pioneered by Dr. David Sinclair.
We have not attained profitable operations and are dependent upon obtaining financing to pursue the Phase II clinical trials in Helsinki, Finland.
We anticipate that additional funding will be required in the form of equity financing from the sale of our common stock or loans from our director. However, we may not be able to raise sufficient funding from the sale of our common stock to fund our operations.
There has been no bankruptcy, receivership or similar proceeding.
There have been no material reclassifications, mergers, consolidations, or purchase or sale of a significant amount of assets not in the ordinary course of business.
We are required to comply with all regulations, rules and directives of governmental authorities and agencies applicable to the clinical testing and manufacturing of pharmaceutical product.
We have one patent application with the US Patent Office (US Patent application, Jan. 10, 2005, Appln. S.N. 11/031,534) (see exhibit 6) The Company was informed on Oct. 15, 2010, that the Examiner has approved the application and that the US Patent will be granted. We are in the planning stages of branding and naming our future product. We plan to trademark the product name and the overall weight loss program. We have no current plans for any registrations such as franchises, concessions, royalty agreements or labor contracts. We will assess the need for any of these applications on an ongoing basis.
We are required to apply for or have any government approval for our products or services.
We have expended $761,412 for research and development costs since inception.
LIQUIDITY AND CAPITAL RESOURCES
Our cash reserves are not sufficient to meet our obligations for the next twelve month period. As a result, we will need to seek additional funding in the near future. We currently do not have a specific plan of how we will obtain such funding; however, we anticipate that additional funding will be in the form of equity financing from the sale of our common stock. We may also seek to obtain short-term loans from our directors, although no such arrangements have been made. At this time, we cannot provide investors with any assurance that we will be able to obtain sufficient funding from the sale of our common stock or through a loan from our directors to meet our obligations over the next twelve months. We do not have any arrangements in place for any future equity financing.
RESULTS OF OPERATIONS
We did not earn any revenues during the three month period ending October 31, 2010 and have generated no revenues since inception. We have incurred operating expenses in the amount of $281,754 for the three month period ending October 31, 2010. For the same three month period ending October 31, 2009 our operating expenses were $76,214.
Our net loss for the three month period ending October 31, 2010 was $281,754 and our net loss from inception through October 31, 2010 was $2,353,674.
At October 31, 2010, we had assets of $21,871 and at the same date current liabilities of $898,912.
The following table provides selected financial data about our Company as at October 31, 2010 and July 31, 2010:
Balance Sheet Data:
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10/31/10
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7/31/10
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||||||
Cash
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$ | 2,300 | $ | 2,300 | ||||
Total assets
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$ | 21,871 | $ | 22,125 | ||||
Total Liabilities
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$ | 898,912 | $ | 659,412 | ||||
Shareholder's equity(deficit)
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$ | (877,041 | ) | $ | (637,287 | ) |
We have not attained profitable operations and are dependent upon obtaining financing to pursue the clinical trials in Helsinki, Finland. In their report on our audited financial statements as at July 31, 2010, our auditors raised substantial doubt about our ability to continue as a going concern unless we are able to raise additional capital and ultimately to generate profitable operations.
It is suggested that these financial statements be read in conjunction with our July 31, 2009 audited financial statements and notes thereto, which can be found in our Form 10-K annual filing and amendments thereto, on the SEC website at www.sec.gov under our SEC File Number 333-139915.
Our significant accounting policies are as follows:
PATENT OWNERSHIP
The user patents that were acquired by the company from Dr. David Sinclair, in exchange for 20,333,333 restricted common shares on August 24, 2009. (see Exhibit 5, Sinclair Agreement Form 10-K) The safe and effective treatment is a proprietary patented pharmaceutical medicine-based behavior program pioneered by Dr. David Sinclair. The company plans to file and obtain the necessary requirements to conduct Phase II clinical trials in Helsinki, Finland. There is no guarantee that we will obtain the approval from the Finnish authorities to conduct the trials and the company will need to obtain the required financing if granted the approvals to conduct the trials. To date the company has not been granted the regulatory approval to conduct the trials.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
As a smaller reporting Company we are not required to provide the disclosure required by this item.
Item 4. Controls and Procedures.
Under the supervision and with the participation of our management, including our principal executive officer and the principal financial officer, we have conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities and Exchange Act of 1934, as of the end of the period covered by this report. Based on this evaluation, our principal executive officer and principal financial officer concluded as of the evaluation date that our disclosure controls and procedures were effective such that the material information required to be included in our Securities and Exchange Commission reports is accumulated and communicated to our management, including our principal executive and financial officer, recorded, processed, summarized and reported within the time periods specified in SEC rules and forms relating to our company, particularly during the period when this report was being prepared.
CHANGES IN INTERNAL CONTROLS OVER FINANCIAL REPORTING
There have been no changes in our internal control over financial reporting that occurred during the last fiscal quarter ended January 31, 2010 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 are not currently involved in any legal proceedings and we are not aware of any pending or potential legal actions.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
There were no sales of unregistered securities during the period of this report.
There were no defaults upon senior securities during the period of this report.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
There were no matters submitted to a vote of security holders during the period covered by this report.
ITEM 5. OTHER INFORMATION
There is no other information.
The following exhibits are included with this quarterly filing. Those marked with an asterisk and required to be filed hereunder, are incorporated by reference and can be found in their entirety in our form SB-2 Registration Statement, filed under SEC File Number 333-146934, at the SEC website at www.sec.gov:
Exhibit Number
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Description |
3.1
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Articles of Incorporation*
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3.2
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Bylaws*
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31.1
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31.2
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32.1
|
|
32.2
|
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Lightlake Therapeutics Inc.
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Date: December 14, 2010
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By:
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/s/ Dr. Roger Crystal
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Name Dr. Roger Crystal
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Title Chief Executive Officer and President
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Date: December 14, 2010
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By:
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/s/ Seijin Ki
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Name Seijin Ki
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Title Chief Financial Officer and Director
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