PART
1 - FINANCIAL INFORMATION
Item 1. Interim Consolidated Financial
Statements
.
The
information in this report for the six months ended December 31, 2013, is
unaudited but includes all adjustments (consisting only of normal recurring
accruals, unless otherwise indicated) which Molecular Pharmacology (USA)
Limited ("
Molecular USA
" or the "
Company
") considers necessary for a fair
presentation of the financial position, results of operations, changes in
stockholders' deficiency and cash flows for those periods.
The
interim consolidated financial statements should be read in conjunction with
Molecular USA's consolidated financial statements and the notes thereto
contained in Molecular USA's Audited Financial Statements for the year ended
June 30, 2013, in the Form 10-K filed with the Securities and Exchange
Commission ("
SEC
") on August 13, 2013.
Interim
results are not necessarily indicative of results for the full fiscal year.
The
unaudited interim consolidated financial statements start on the next page.
1
Molecular Pharmacology (USA)
Limited
(A Development Stage Company)
Interim Consolidated
Financial Statements
(Expressed
in U.S. Dollars)
(Unaudited)
31 December 2013
2
Molecular Pharmacology (USA)
Limited
(A Development Stage
Company)
Interim Consolidated Balance Sheets
(Expressed in U.S. Dollars)
(Unaudited)
|
|
As at
31 December
2013
|
|
As at
30 June
2013
(Audited)
|
|
|
$
|
|
$
|
Assets
|
|
|
|
|
|
|
|
|
|
Current
|
|
|
|
|
Cash and cash
equivalents
|
|
4,997
|
|
7,046
|
Amounts
receivable
|
|
4,465
|
|
5,070
|
|
|
|
|
|
|
|
9,462
|
|
12,116
|
|
|
|
|
|
Equipment
(Note 5)
|
|
118
|
|
140
|
|
|
|
|
|
|
|
9,580
|
|
12,256
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
Current
|
|
|
|
|
Accounts payable
and accrued liabilities (Note 6)
|
|
20,482
|
|
21,628
|
|
|
|
|
|
Due
to related parties
(Note 7)
|
|
2,051,979
|
|
2,044,501
|
|
|
|
|
|
|
|
2,072,461
|
|
2,066,129
|
|
|
|
|
|
Stockholders’
deficiency
|
|
|
|
|
Capital
stock
(Note 8)
|
|
|
|
|
Authorized
|
|
|
|
|
300,000,000 common shares, par value
$0.001
|
|
|
|
|
Issued and
outstanding
|
|
|
|
|
31 December 2013
– 111,553,740 common shares, par value $0.001
|
|
|
|
|
30 June 2013 – 111,553,740 common
shares, par value $0.001
|
|
111,554
|
|
111,554
|
Additional
paid-in capital
|
|
106,707
|
|
106,707
|
Cumulative
translation adjustment
|
|
(155,867)
|
|
(210,186)
|
Deficit,
accumulated during the development stage
|
|
(2,125,275)
|
|
(2,061,948)
|
|
|
|
|
|
|
|
(2,062,881)
|
|
(2,053,873)
|
|
|
|
|
|
|
|
9,580
|
|
12,256
|
Nature and Continuance of Operations
(Note 1)
On behalf of the Board:
/s/ Jeffrey Edwards
Director
Jeffrey Edwards
The accompanying notes are an integral part of these
interim consolidated financial statements.
3
Molecular Pharmacology (USA)
Limited
(A Development Stage
Company)
Interim
Consolidated Statements of Operations
(Expressed in U.S. Dollars)
(Unaudited)
|
For the
period from
the date of
inception on
14 July 2004
to
31 December
2013
|
For the
three month
period ended
31 December
2013
|
For the
three month
period ended
31 December
2012
|
For the
six month
period ended
31 December
2013
|
For the
six month
period ended
31 December
2012
|
|
$
|
$
|
$
|
$
|
$
|
|
|
|
|
|
|
Expenses
|
|
|
|
|
|
Advertising and promotion
|
23,739
|
-
|
-
|
-
|
-
|
Amortization
(Note 5)
|
6,909
|
11
|
84
|
22
|
170
|
Analysis
|
33,947
|
-
|
-
|
-
|
-
|
Consulting (Note
7)
|
1,447,831
|
8,182
|
30,638
|
23,467
|
64,118
|
Office and
miscellaneous (Note 7)
|
262,031
|
5,050
|
6,786
|
15,170
|
15,780
|
Professional fees
|
426,581
|
7,347
|
10,566
|
21,044
|
19,743
|
Public relations
|
3,656
|
-
|
-
|
-
|
-
|
Rent (Note 7)
|
27,759
|
-
|
-
|
-
|
-
|
Salaries and benefits
|
44,464
|
-
|
-
|
-
|
-
|
Transfer agent
and filing fees
|
20,796
|
1,964
|
-
|
3,624
|
-
|
Travel
|
111,710
|
-
|
-
|
-
|
359
|
|
|
|
|
|
|
Net
loss before other items
|
(2,409,423)
|
(22,554)
|
(48,074)
|
(63,327)
|
(100,170)
|
|
|
|
|
|
|
Other
items
|
|
|
|
|
|
Export market development grants
|
69,629
|
-
|
-
|
-
|
-
|
Write-off of equipment
|
(823)
|
-
|
(823)
|
-
|
(823)
|
Interest income
|
2,322
|
-
|
-
|
-
|
-
|
Research and development tax refund
|
213,020
|
-
|
-
|
-
|
-
|
|
|
|
|
|
|
Net
loss for the period
|
(2,125,275)
|
(22,554)
|
(48,897)
|
(63,327)
|
(100,993)
|
|
|
|
|
|
|
Basic and
diluted loss per common share
|
(0.001)
|
(0.001)
|
(0.001)
|
(0.001)
|
|
|
|
|
|
Weighted
average number of common shares used in per share calculations
|
111,553,740
|
111,553,740
|
111,553,740
|
111,553,740
|
|
|
|
|
|
|
Comprehensive
income (loss)
|
|
|
|
|
|
Net loss for the period
|
(2,125,275)
|
(22,554)
|
(48,897)
|
(63,327)
|
(100,993)
|
Foreign currency
translation adjustment
|
(155,867)
|
93,600
|
(1,829)
|
54,319
|
(32,763)
|
|
|
|
|
|
|
Total
comprehensive income (loss) for the period
|
(2,281,142)
|
71,046
|
(50,726)
|
(9,008)
|
(133,756)
|
|
|
|
|
|
|
Basic
and diluted comprehensive income (loss) per common share
|
0.001
|
(0.001)
|
(0.001)
|
(0.001)
|
The accompanying notes are an integral part of these
interim consolidated financial statements.
4
Molecular Pharmacology (USA)
Limited
(A Development Stage
Company)
Interim
Consolidated Statements of Cash Flows
(Expressed in U.S. Dollars)
(Unaudited)
|
For the
period
from
the
date of
inception on
14 July
2004
to
31
December
2013
|
For the
three
month
period
ended
31 December
2013
|
For the
three
month
period
ended
31 December
2012
|
For the
six
month
period
ended
31
December
2013
|
For the
six month
period
ended
31
December
2012
|
|
$
|
$
|
$
|
$
|
$
|
|
|
|
|
|
|
Cash flows used in operating activities
|
|
|
|
|
|
Net loss for the period
|
(2,125,275)
|
(22,554)
|
(48,897)
|
(63,327)
|
(100,993)
|
Adjustments to reconcile net
loss to cash used by operating activities
|
|
|
|
|
|
Amortization
|
6,909
|
11
|
84
|
22
|
170
|
Write-down of
intangible assets
|
1,278
|
-
|
-
|
-
|
-
|
Write-off of equipment
|
823
|
-
|
823
|
-
|
823
|
Changes in operating assets and liabilities
|
|
|
|
|
|
Decrease (increase) in amounts receivable
|
(2,239)
|
958
|
(673)
|
605
|
(2,411)
|
Decrease in accounts payable and
accrued liabilities
|
(26,935)
|
(13,918)
|
(11,116)
|
(1,146)
|
(12,068)
|
|
(2,145,439)
|
(35,503)
|
(59,779)
|
(63,846)
|
(114,479)
|
|
|
|
|
|
|
Cash flows from investing activities
|
|
|
|
|
|
Purchase of equipment
|
(7,850)
|
-
|
-
|
-
|
-
|
Purchase of intangible assets
|
(1,278)
|
-
|
-
|
-
|
-
|
Cash acquired on the purchase of Molecular Pharmacology (USA) Limited
|
37,163
|
-
|
-
|
-
|
-
|
|
28,035
|
-
|
-
|
-
|
-
|
|
|
|
|
|
|
Cash flows from (used in) financing activities
|
|
|
|
|
|
Common shares issued for cash
|
234,497
|
-
|
-
|
-
|
-
|
Increase (decrease) in due to related parties
|
2,043,771
|
(60,250)
|
56,159
|
7,478
|
150,664
|
|
2,278,268
|
(60,250)
|
56,159
|
7,478
|
150,664
|
|
|
|
|
|
|
Effect of exchange rate changes on cash
|
(155,867)
|
93,600
|
(1,829)
|
54,319
|
(32,763)
|
|
|
|
|
|
|
Increase (decrease) in cash and cash equivalents
|
4,997
|
(2,153)
|
(5,449)
|
(2,049)
|
3,422
|
|
|
|
|
|
|
Cash and cash equivalents, beginning of period
|
-
|
7,150
|
11,443
|
7,046
|
2,572
|
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
4,997
|
4,997
|
5,994
|
4,997
|
5,994
|
Supplemental Disclosures with Respect to Cash
Flows
(Note 12)
The accompanying notes are an integral part of these
interim consolidated financial statements.
5
Molecular Pharmacology (USA)
Limited
(A Development Stage
Company)
Interim Consolidated Statements of Changes in Stockholders’ Deficiency
(Expressed in U.S. Dollars)
(Unaudited)
|
Number of
common shares
issued
|
Capital stock
|
Additional
paid-in capital
|
Deficit,
accumulated
during the
development stage
|
Cumulative
translation
adjustment
|
Stockholders'
deficiency
|
|
|
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
Balance at 14 July 2004 (inception)
|
|
294
|
|
-
|
|
1
|
|
-
|
|
-
|
|
1
|
Net loss for the period
|
|
-
|
|
-
|
|
-
|
|
(128,488)
|
|
-
|
|
(128,488)
|
Cumulative translation adjustment
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(6,536)
|
|
(6,536)
|
Balance at 31 October 2004
|
|
294
|
|
-
|
|
1
|
|
(128,488)
|
|
(6,536)
|
|
(135,023)
|
Common shares issued for cash - January 2005
|
|
87,999,706
|
|
88,000
|
|
146,496
|
|
-
|
|
-
|
|
234,496
|
Net loss for the year
|
|
-
|
|
-
|
|
-
|
|
(387,667)
|
|
-
|
|
(387,667)
|
Cumulative translation adjustment
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(161)
|
|
(161)
|
Balance at 31 October 2005
|
|
88,000,000
|
|
88,000
|
|
146,497
|
|
(516,155)
|
|
(6,697)
|
|
(288,355)
|
Acquisition of Molecular Pharmacology (USA) Limited - Recapitalization May 2006
|
|
43,553,740
|
|
43,554
|
|
(59,790)
|
|
-
|
|
-
|
|
(16,236)
|
Cancellation of common shares - July 2006
|
|
(20,000,000)
|
|
(20,000)
|
|
20,000
|
|
-
|
|
-
|
|
-
|
Net loss for the year
|
|
-
|
|
-
|
|
-
|
|
(508,260)
|
|
-
|
|
(508,260)
|
Cumulative translation adjustment
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(16,222)
|
|
(16,222)
|
Balance at 31 October 2006
|
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,024,415)
|
|
(22,919)
|
|
(829,073)
|
Net loss for the period
|
|
-
|
|
-
|
|
-
|
|
(377,131)
|
|
-
|
|
(377,131)
|
Cumulative translation
adjustment
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(105,436)
|
|
(105,436)
|
Balance at 30 June 2007
|
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,401,546)
|
|
(128,355)
|
|
(1,311,640)
|
Net income for the year
|
|
-
|
|
-
|
|
-
|
|
62,296
|
|
-
|
|
62,296
|
Cumulative translation
adjustment
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(166,483)
|
|
(166,483)
|
Balance at 30 June 2008
|
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,339,250)
|
|
(294,838)
|
|
(1,415,827)
|
Net loss for the year
|
|
-
|
|
-
|
|
-
|
|
(94,336)
|
|
-
|
|
(94,336)
|
Cumulative translation
adjustment
|
|
-
|
|
-
|
|
-
|
|
-
|
|
219,034
|
|
219,034
|
Balance at 30 June 2009
|
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,433,586)
|
|
(75,804)
|
|
(1,291,129)
|
Net loss for the year
|
|
-
|
|
-
|
|
-
|
|
(117,220)
|
|
-
|
|
(117,220)
|
Cumulative translation
adjustment
|
|
-
|
|
-
|
|
-
|
|
-
|
|
(78,521)
|
|
(78,521)
|
Balance at 30 June 2010
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,550,806)
|
|
(154,325)
|
|
(1,486,870)
|
Net loss for the year
|
-
|
|
-
|
|
-
|
|
(121,860)
|
|
-
|
|
(121,860)
|
Cumulative translation
adjustment
|
-
|
|
-
|
|
-
|
|
-
|
|
(357,962)
|
|
(357,962)
|
Balance at 30 June 2011
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,672,666)
|
|
(512,287)
|
|
(1,966,692)
|
Net loss for the year
|
-
|
|
-
|
|
-
|
|
(179,382)
|
|
-
|
|
(179,382)
|
Cumulative translation
adjustment
|
-
|
|
-
|
|
-
|
|
-
|
|
66,215
|
|
66,215
|
Balance at 30 June 2012
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(1,852,048)
|
|
(446,072)
|
|
(2,079,859)
|
Net loss for the year
|
-
|
|
-
|
|
-
|
|
(209,900)
|
|
-
|
|
(209,900)
|
Cumulative translation
adjustment
|
-
|
|
-
|
|
-
|
|
-
|
|
(235,886)
|
|
(235,886)
|
Balance at 30 June 2013
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(2,061,948)
|
|
(210,186)
|
|
(2,053,873)
|
Net loss for the period
|
-
|
|
-
|
|
-
|
|
(63,327)
|
|
-
|
|
(63,327)
|
Cumulative translation
adjustment
|
-
|
|
-
|
|
-
|
|
-
|
|
54,319
|
|
54,319
|
Balance at 31 December 2013
|
111,553,740
|
|
111,554
|
|
106,707
|
|
(2,125,275)
|
|
(155,867)
|
|
(2,062,881)
|
The accompanying notes are an integral part of these
interim consolidated financial statements.
6
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31 December 2013
1.
Nature and Continuance of Operations
Molecular Pharmacology (USA)
Limited (the "Company") was incorporated in the state of Nevada on
1 May 2002 under the name Blue Hawk Ventures, Inc. The Company changed its name to
Molecular Pharmacology (USA) Limited on 29 August 2005. At the same time, the Company completed
a four for one forward split of its issued and outstanding share capital and
altered its authorized share capital to 300,000,000 shares of common stock with
a par value of $0.001 per share.
The Company is a development
stage enterprise, as defined in
Accounting Standards Codification
(the "Codification" or
"ASC") 915-10, "
Development Stage Entities
".
The Company is devoting all of its present efforts to securing and establishing
a new business and its current planned principle operations have not
commenced. Accordingly, no revenue
has been derived during the organization period.
Up until the fall of 2005,
the Company was in the business of mineral exploration and development of a
mineral property. The Company
allowed the option on its mineral claim to lapse in the fall of 2005.
On 13 October 2005, the
Company acquired the exclusive distribution rights to distribute, market,
promote, detail, advertise and sell certain "Licensed Products"
through Molecular Pharmacology Pty. Ltd. (formerly Molecular Pharmacology
Limited) ("MPLA") (Note 10).
MPLA was incorporated under the laws of Australia and converted to a
proprietary company on 29 October 2009.
MPLA is a wholly owned subsidiary company of PharmaNet Group Limited
("PharmaNet"), an
Australian company listed on the Australian Stock Exchange.
Since then, the Company has
engaged in organizational and start up activities, including developing a new
business plan, recruiting new directors, scientific advisors and key
scientists, making arrangements for laboratory facilities and office space and
raising additional capital. The
Company has generated no revenue from product sales. The Company does not have any
pharmaceutical products currently available for sale, and none are expected to
be commercially available for some time, if at all. The Licensed Products must first undergo
pre-clinical and human clinical testing in the United States before they may be
sold commercially.
The Company completed a
share purchase agreement on 8 May 2006 with PharmaNet (the "Purchase
Agreement"). Under the terms
of the Purchase Agreement the Company acquired 100% of the issued and
outstanding shares of MPLA. The
Company, in exchange for 100% of the issued and outstanding shares of MPLA,
issued PharmaNet an aggregate total of 88,000,000 common shares of the Company
on the closing of the transaction.
The issuance of 88,000,000 common shares of the Company constituted an
acquisition of control of the Company by PharmaNet. The transaction has been accounted for
as a recapitalization of the Company (Note 2).
MPLA was incorporated on 14
July 2004 under the laws of Australia.
The accompanying interim consolidated financial statements are the
historical financial statements of MPLA.
On 15 March 2007, the Board
of Directors approved a change in the Company’s financial year end from
31 October to 30 June. The decision to change the fiscal year end was intended
to assist the financial community in its analysis of the business and in
comparing the Company’s financial results to others in the industry, and
to synchronize the Company’s fiscal reporting with MPLA.
7
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31 December 2013
The Company’s interim consolidated financial statements as at 31 December
2013 and for the six month period then ended have been prepared on a going
concern basis, which contemplates the realization of assets and settlement of
liabilities and commitments in the normal course of business. The Company has a net loss of $63,327
for the six month period ended 31 December 2013 (31 December 2012 – $100,993;
cumulative - $2,125,275) and has working capital deficit of $11,020 at 31 December
2013 (30 June 2013 – $9,512).
Management cannot provide
assurance that the Company will ultimately achieve profitable operations or
become cash flow positive, or raise additional debt and/or equity capital. Management believes that the
Company’s capital resources should be adequate to continue operating and
maintaining its business strategy for the next twelve month period from the
date of these interim consolidated financial statements. However, if the Company is unable to
raise additional capital in the near future, due to the Company’s
liquidity problems, management expects that the Company will need to curtail
operations, liquidate assets, seek additional capital on less favorable terms
and/or pursue other remedial measures.
Management is
aware, in making its assessment, of material uncertainties related to events or
conditions that may cast significant doubt upon the Company’s ability to
continue as a going concern. These interim consolidated financial
statements do not include any adjustments related to the recoverability and
classification of assets or the amounts and classification of liabilities that
might be necessary should the Company be unable to continue as a going concern.
At 31 December 2013, the
Company has suffered losses from development stage activities to date. Although management is currently
attempting to implement its business plan, and is seeking additional sources of
equity or debt financing, there is no assurance these activities will be
successful. These factors raise
substantial doubt about the ability of the Company to continue as a going
concern. The interim consolidated
financial statements do not include any adjustments that might result from the
outcome of this uncertainty.
2.
Significant Accounting Policies
The
following is a summary of significant accounting policies used in the
preparation of these interim consolidated financial statements.
Basis of
presentation
These interim consolidated
financial statements have been prepared in accordance with accounting
principles generally accepted in the United States of America ("U.S.
GAAP") applicable for a development stage company for financial
information and are expressed in U.S. dollars.
Principles of
consolidation
These interim consolidated
financial statements include the accounts of MPLA since its incorporation on 14
July 2004 and the Company since the reverse acquisition on 8 May 2006 (Note
1). All intercompany balances and
transactions have been eliminated.
Cash and cash equivalents
Cash
and cash equivalents include highly liquid investments with original maturities
of three months or less.
8
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31 December 2013
Equipment
Equipment
is recorded at cost and amortization is provided over its estimated economic
life at the rate of 15% declining balance.
Segments of
an enterprise and related information
ASC 280, "
Segment Reporting
" establishes guidance for the way
that public companies report information about operating segments in annual
financial statements and requires reporting of selected information about operating
segments in interim financial statements issued to the public. It also establishes standards for
disclosures regarding products and services, geographic areas and major
customers. ASC 280 defines
operating segments as components of a company about which separate financial
information is available that is evaluated regularly by the chief operating
decision maker in deciding how to allocate resources and in assessing
performance.
Foreign currency
translation
The Company’s functional and reporting currency is U.S.
dollars.
The interim
consolidated financial statements of the Company are translated to U.S. dollars
in accordance with
ASC 830, "
Foreign Currency Matters
". Assets and
liabilities denominated in foreign currencies are translated using the exchange
rate prevailing at the balance sheet date.
Revenue and expenses are translated at average rates of exchange
prevailing during the period. Translation adjustments resulting from this
process are charged or credited to other comprehensive income
.
The
Company has not, to the date of these interim consolidated financial
statements, entered into derivative instruments to offset the impact of foreign
currency fluctuations.
Income taxes
Deferred income taxes are reported for timing
differences between items of income or expense reported in the interim consolidated
financial statements and those reported for income tax purposes in accordance
with ASC 740,
"Income Taxes"
, which
requires the use of the asset/liability method of accounting for income
taxes. Deferred income taxes and
tax benefits are recognized for the future tax consequences attributable to
differences between the financial statement carrying amounts of existing assets
and liabilities and their respective tax bases, and for tax losses and credit
carry-forwards. Deferred tax assets
and liabilities are measured using enacted tax rates expected to apply to
taxable income in the years in which those temporary differences are expected
to be recovered or settled. The
Company provides for deferred taxes for the estimated future tax effects
attributable to temporary differences and carry-forwards when realization is
more likely than not.
9
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31 December 2013
Basic and diluted net
income (loss) per share
The Company computes net
income (loss) per share in accordance with ASC 260, "
Earnings per Share
". ASC 260 requires presentation of both
basic and diluted earnings per share ("EPS") on the face of the
income statement. Basic EPS is
computed by dividing net income (loss) available to common shareholders
(numerator) by the weighted average number of shares outstanding (denominator)
during the period. Diluted EPS
gives effect to all potentially dilutive common shares outstanding during the
period using the treasury stock method and convertible preferred stock using
the if-converted method. In
computing diluted EPS, the average stock price for the period is used in
determining the number of shares assumed to be purchased from the exercise of
stock options or warrants. Diluted
EPS excludes all potentially dilutive shares if their effect is anti-dilutive.
As at 31 December 2013, the Company had no outstanding stock options or
warrants.
Comprehensive income (loss)
ASC 220, "
Comprehensive Income
", establishes
standards for the reporting and disclosure of comprehensive income (loss) and
its components in the financial statements. As at 31 December 2013, the Company has
items that represent a comprehensive loss and, therefore, has included a
schedule of comprehensive loss in the interim consolidated financial
statements.
Stock-based compensation
Effective 1 January 2006,
the Company adopted the provisions of ASC 718, "
Compensation
– Stock Compensation
", which establishes accounting for
equity instruments exchanged for employee services. Under the provisions of ASC
718, stock-based compensation cost is measured at the grant date, based on the
calculated fair value of the award, and is recognized as an expense over the
employees’ requisite service period (generally the vesting period of the
equity grant). The Company adopted ASC 718 using the modified prospective
method, which requires the Company to record compensation expense over the
vesting period for all awards granted after the date of adoption, and for the
unvested portion of previously granted awards that remain outstanding at the date
of adoption. Accordingly, the financial statements for the periods prior
to 1 January 2006 have not been restated to reflect the fair value method of
expensing share-based compensation. The adoption of ASC 718 does not
change the way the Company accounts for share-based payments to non-employees,
with guidance provided by ASC 505-50, "
Equity-Based
Payments to Non-Employees
".
Comparative
figures
Certain comparative figures
have been adjusted to conform to the current period’s presentation.
10
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31 December 2013
3.
Changes in Accounting Policies
Effective
1 July 2013, the Company adopted ASU 2013-05, "
Foreign
Currency Matters (Topic 830) – Parent’s Accounting for the
Cumulative Translation Adjustment upon Derecognition of Certain Subsidiaries or
Group of Assets within a Foreign Entity or of an Investment in a Foreign Entity
".
These amendments provide guidance on releasing cumulative translation
adjustments when a reporting entity (parent) ceases to have a controlling
financial interest in a subsidiary or a group of assets that is a non-profit
activity or a business within a foreign entity. In addition, these amendments
provide guidance on the release of cumulative translation adjustments in
partial sales of equity method investments and in step acquisitions. The
adoption of these amendments did not have an impact on the Company’s
interim consolidated financial statements.
Effective
1 July 2013, the Company adopted ASU 2013-04, "
Liabilities
(Topic 405) – Obligations Resulting from Joint and Several Liability
Arrangements for Which the Total Amount of the Obligation is Fixed at the
Reporting Date
". These amendments provide guidance for the
recognition, measurement, and disclosure of obligations resulting from joint
and several liability arrangements for which the total amount of the obligation
within the scope of this guidance is fixed at the reporting date, except for
obligations addressed within existing guidance in U.S. GAAP. The adoption of
these amendments did not have an impact on the Company’s interim
consolidated financial statements.
Effective
1 July 2013, the Company adopted ASU 2013-02, "
Comprehensive
Income (Topic 220) – Reporting of Amounts Reclassified out of Accumulated
Other Comprehensive Income
". The amendments require an entity to
provide information about the amounts reclassified out of accumulated other
comprehensive income by component. In addition, an entity is required to
present, either on the face of the statement where net income is presented or
in the notes, significant amounts reclassified out of accumulated other
comprehensive income by the respective line items of net income but only if the
amount reclassified is required under U.S. GAAP to be reclassified to net
income in its entirety in the same reporting period. For other amounts that are
not required under U.S. GAAP to be reclassified in their entirety to net income,
an entity is required to cross reference to other disclosures required under
U.S. GAAP that provide additional details about those amounts. The adoption of
these amendments did not have an impact on the Company’s interim
consolidated financial statements.
11
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31 December 2013
4.
Recent Accounting Pronouncements
Certain
new standards, interpretations, amendments and improvements to existing
standards were issued by FASB. The new standards, amendments to standards and
interpretations that have been issued and that are applicable to the Company
but not effective during the six month period ended 31 December 2013 are as
follows:
In
July 2013, the FASB issued ASU 2013-11, "
Income Taxes
(Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating
Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exist
".
These amendments require that an unrecognized tax benefit, or a portion of an
unrecognized tax benefit, should be presented in the financial statements as a
reduction to a deferred tax asset for a net operating loss carryforward, a
similar tax loss, or a tax credit carryforward except as follows. To the extent
a net operating loss carryforward, a similar tax loss, or a tax credit
carryforward is not available at the reporting date under the tax law of the
applicable jurisdiction to settle any additional income taxes that would result
from a disallowance of a tax position or the tax law of the applicable
jurisdiction does not require the entity to use, and the entity does not intend
to use, the deferred tax asset for such purpose, the unrecognized tax benefit
should be presented in the financial statements as a liability and should not
be combined with deferred tax assets. These amendments are effective for fiscal
years, and interim periods within those years, beginning after 15 December
2013. The amendments should be applied prospectively to all unrecognized tax
benefits that exist at the effective date. Retrospective application and early
adoption is permitted. The adoption is not expected to have a material impact
on the Company’s consolidated financial statements.
5.
Equipment
|
|
|
|
|
|
Net Book Value
|
|
|
Cost
|
|
Accumulated amortization
|
|
As at
31 December
2013
|
|
As at
30 June
2013
(Audited)
|
|
|
$
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
|
|
|
Office equipment
|
|
864
|
|
746
|
|
118
|
|
140
|
During the six month period
ended 31 December 2013, the total additions to equipment were $Nil (31 December
2012 – $Nil).
6.
Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities are
non-interest bearing, unsecured and have settlement dates within one year.
7.
Due to Related Parties and Related Party Transactions
As at 31 December 2013, the amount due to related parties includes
$1,000 payable to a director of the Company (30 June 2013
–
$1,000). This balance is non-interest bearing,
unsecured and has no fixed terms of repayment.
12
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31 December 2013
As at 31 December 2013, the amount due to related parties includes
$34,533 payable to a company owned by a director of the Company or an officer
of PharmaNet (30 June 2013
–
$18,009). This
balance is non-interest bearing, unsecured and has no fixed terms of repayment.
As at 31 December 2013, the amount due to related parties includes
$4,885 payable to a company owned by a director of the Company or an officer of PharmaNet (30 June 2013
–
$2,772). This
balance is non-interest bearing, unsecured and has no fixed terms of repayment.
As at 31 December 2013, the amount due to related parties includes
$7,427 payable to a company owned by a director of the Company or an officer of
PharmaNet (30 June 2013 - $15,252).
This balance is non-interest bearing, unsecured and has no fixed terms
of repayment.
As at 31 December 2013, the amount due to related parties includes
$2,004,134 payable to PharmaNet (30 June 2013
–
$2,007,468). This balance is non-interest bearing,
unsecured and has no fixed terms of repayment.
During the six
months period ended 31 December 2013, a director of the Company or an officer
of PharmaNet, and their controlled entities were paid or accrued consulting
fees of $16,494 (
31 December 2012
– $18,015, cumulative - $912,673).
During the six months period ended 31 December 2013, a director of
the Company or an officer of PharmaNet, and their controlled entities were paid
or accrued administrative fees of $14,249 (
31
December 2012
–
$13,558, cumulative - $82,543) by the
Company, which have been recorded in office and miscellaneous expense.
During the six months period ended 31 December 2013, a director of
the Company or an officer of PharmaNet, and their controlled entities were paid
or accrued consulting fees of $6,973 (31 December 2012 - $44,285, cumulative -
$118,634) by the Company.
During the six months period ended 31 December 2013, a director of
the Company or an officer of PharmaNet, and their controlled entities were paid
or accrued consulting fees of $Nil (31 December 2012 – $Nil, cumulative
– $41,928) by the Company.
During the six months period ended 31 December 2013, a director of
the Company or an officer of PharmaNet, and their controlled entities were paid
or accrued office and miscellaneous expenses of $Nil (
31
December 2012
–
$Nil, cumulative
–
$80,468) by the Company.
During the six months period ended 31 December 2013, a director of
the Company or an officer of PharmaNet, and their controlled entities were paid
or accrued rental fees of $Nil (
31 December 2012
– $Nil, cumulative –
$12,987) by the Company.
During the six months period ended 31 December 2013, a director of
the Company or an officer of PharmaNet, and their controlled entities were paid
or accrued office and miscellaneous expenses of $Nil (31 December 2012 - $Nil,
cumulative – $4,481) by the Company.
During the six months period ended 31 December 2013, a director of
the Company or an officer of PharmaNet, and their controlled entities were paid
or accrued consulting fees of $Nil (31 December 2012 - $Nil, cumulative -
$8,473) by the Company.
13
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31 December 2013
Transactions comprising the amount due to PharmaNet are as
follows:
|
|
For the
six month
period
ended
31
December
2013
|
|
For the
year
ended
30 June
2013
(Audited)
|
|
|
$
|
|
$
|
|
|
|
|
|
Opening balance, beginning of period
|
|
2,007,468
|
|
2,036,760
|
Funds
transferred to the Company by PharmaNet
|
|
49,752
|
|
204,583
|
Expenses paid by PharmaNet on behalf of the
Company
|
|
357
|
|
1,004
|
Foreign
currency translation adjustment
|
|
(53,443)
|
|
(234,879)
|
|
|
|
|
|
Balance, end of period
|
|
2,004,134
|
|
2,007,468
|
The weighted average amount due to PharmaNet for the six month
period ended 31 December 2013 was $2,033,690 (30 June 2013 - $2,160,632).
8.
Capital Stock
Authorized
The total authorized capital is 300,000,000 common
shares with a par value of $0.001 per common share.
Issued and outstanding
The total issued and outstanding capital stock is 111,553,740
common shares with a par value of $0.001 per common share.
9.
Segmented Information
Details on a geographic basis as at and for the six
month period ended 31 December 2013 are as follows:
|
Australia
|
|
U.S.A.
|
|
Total
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
Current assets
|
9,462
|
|
-
|
|
9,462
|
Long-term assets
|
118
|
|
-
|
|
118
|
Loss for the period
|
(38,659)
|
|
(24,668)
|
|
(63,327)
|
14
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31 December 2013
Details on a geographic basis as at and for the year
ended 30 June 2013 are as follows:
|
Australia
|
|
U.S.A.
|
|
Total
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
Current assets
|
12,116
|
|
-
|
|
12,116
|
Long-term assets
|
140
|
|
-
|
|
140
|
Loss for the year
|
(162,485)
|
|
(47,415)
|
|
(209,900)
|
Details on a geographic basis as at and for the six
month period ended 31 December 2012 are as follows:
|
Australia
|
|
U.S.A.
|
|
Total
|
|
$
|
|
$
|
|
$
|
|
|
|
|
|
|
Current assets
|
13,515
|
|
-
|
|
13,515
|
Long-term assets
|
166
|
|
-
|
|
166
|
Loss for the period
|
(80,353)
|
|
(20,640)
|
|
(100,993)
|
10.
Distribution Agreement
The
Company has the exclusive distribution rights, through MPLA, to distribute,
market, promote, detail, advertise and sell certain Licensed Products, with
metallo-polypeptide analgesic as an active ingredient, in the United States
(excluding its territories and possessions) (Note 1).
If, and when necessary, the Company will
obtain all necessary regulatory approvals for the Licensed Products and
incorporate the Licensed Products in the United States.
15
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31 December 2013
11.
Income Taxes
Income tax expense differs from the amount that would result from
applying the federal income tax rate to earnings before income taxes. The differences result from the
following items:
|
|
For the six month period ended 31 December 2013
|
|
For the six month period ended 31 December 2012
|
|
|
$
|
|
$
|
|
|
|
|
|
Loss before income taxes
|
|
(63,327)
|
|
(100,993)
|
|
|
|
|
|
Federal
income tax rates
|
|
35.0%
|
|
34.0%
|
|
|
|
|
|
Income tax recovery based
on the above rates
|
|
(22,164)
|
|
(34,338)
|
|
|
|
|
|
Increase (decrease) due
to:
|
|
|
|
|
Difference between U.S. and foreign tax rates
|
|
1,933
|
|
3,214
|
Change in valuation allowance
|
|
9,531
|
|
37,579
|
Foreign exchange and other
|
|
10,700
|
|
(6,455)
|
|
|
|
|
|
Income tax expense
|
|
-
|
|
-
|
The composition of the Company’s deferred tax assets as at 31 December
2013 and 30 June 2013 are as follows:
|
|
As at
31
December
2013
|
|
As at
30 June
2013
(Audited)
|
|
|
$
|
|
$
|
|
|
|
|
|
Net income tax operating loss
carry-forward
|
|
2,152,933
|
|
2,125,274
|
|
|
|
|
|
Deferred tax assets
|
|
687,320
|
|
677,789
|
Less:
Valuation allowance
|
|
(687,320)
|
|
(677,789)
|
|
|
|
|
|
Net deferred tax asset
|
|
-
|
|
-
|
16
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31 December 2013
The Company has non-capital loss carry-forwards of approximately $2,152,933
that may be available for tax purposes.
The loss carry-forwards are all in respect to U.S. and Australian
operations and expire as follows:
|
$
|
|
|
2022
|
20,402
|
2023
|
46,992
|
2024
|
27,717
|
2025
|
14,187
|
2026
|
261,311
|
2027
|
111,155
|
2028
|
75,463
|
2029
|
57,882
|
2030
|
48,765
|
2031
|
43,836
|
2032
|
49,005
|
2033
|
47,415
|
2034
|
24,668
|
No expiry
|
1,324,135
|
|
|
|
2,152,933
|
A full valuation allowance has been recorded against the potential
deferred tax assets associated with all the loss carry-forwards as their
utilization is not considered more likely than not at this time.
12.
Supplemental Disclosures with Respect to Cash Flows
|
For the
period from
the date of inception on
14 July 2004
to
31 December
2013
|
For the three
month
period
ended
31 December
2013
|
For the three
month
period
ended
31 December
2012
|
For the six
month period
ended
31 December
2013
|
For the six
month period
ended
31 December
2012
|
|
$
|
$
|
$
|
$
|
$
|
|
|
|
|
|
|
Cash paid during the
period for interest
|
-
|
-
|
-
|
-
|
-
|
Cash paid during the
period for income taxes
|
-
|
-
|
-
|
-
|
-
|
Common shares issued
on acquisition of MPLA
|
16,236
|
-
|
-
|
-
|
-
|
Amounts receivable
acquired on recapitalization of the Company
|
2,226
|
-
|
-
|
-
|
-
|
Accounts payable
assumed on recapitalization of the Company
|
54,624
|
-
|
-
|
-
|
-
|
Due to related party
assumed on recapitalization of the Company
|
1,000
|
-
|
-
|
-
|
-
|
17
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31 December 2013
13.
Financial Instruments
A fair value hierarchy was
established that prioritizes the inputs used to measure fair value. The hierarchy gives the highest priority
to unadjusted quoted prices in active markets for identical assets or
liabilities (Level 1 measurement) and the lowest priority to unobservable
inputs (Level 3 measurements).
The fair values of the
financial instruments were determined using the following input levels and
valuation techniques:
Level 1: classification is applied to any asset
or liability that has a readily available quoted market price from an active
market where there is significant transparency in the executed/quoted price.
Level 2: classification is applied to assets and
liabilities that have evaluated prices where the data inputs to these
valuations are observable either directly or indirectly, but do not represent
quoted market prices from an active market.
Level 3: classification is applied to assets and
liabilities when prices are not derived from existing market data and requires
us to develop our own assumptions about how market participants would price the
asset or liability.
The carrying values of cash
and cash equivalents, amounts receivable and accounts payable approximate fair
value due to the short term maturity of these financial instruments.
Credit Risk
Financial instruments that
potentially subject the Company to credit risk consists of cash and cash
equivalents. The Company deposits cash and cash equivalents with high credit
quality financial institutions as determined by rating agencies. As a result, credit risk is considered
insignificant.
Currency Risk
The Company’s
subsidiary is located in Australia. As a result, a significant portion of the
Company’s assets, liabilities and expenses were denominated in the
Australian dollar and were therefore subject to fluctuation in exchange
rates.
The Company’s
objective in managing its foreign currency risk is to minimize its net
exposures to foreign currency cash flows by holding most of its cash and cash
equivalents in Australian dollars.
The Company monitors and forecasts the values of net foreign currency
cash flow and balance sheet exposures and from time to time could authorize the
use of derivative financial instruments such as forward foreign exchange
contracts to economically hedge a portion of foreign currency fluctuations.
If the Australian dollar had
weakened (strengthened) against the U.S. dollar, with all other variables held
constant, by 100 basis points (1%) at period end, the impact on net loss and
other comprehensive loss would have been $20,415 lower ($20,415 higher).
The Company has not, to the
date of these interim consolidated financial statements, entered into
derivative instruments to offset the impact of foreign currency fluctuations.
18
Molecular Pharmacology
(USA) Limited
(A Development Stage
Company)
Notes to Interim Consolidated Financial Statements
(Expressed in U.S. Dollars)
(Unaudited)
31 December 2013
Interest Rate Risk
The Company has non-interest
paying cash balances and no interest-bearing debt. It is
management’s opinion that the Company is not exposed to significant
interest risk arising from these financial instruments.
Liquidity Risk
Liquidity risk is the risk
that an entity will encounter difficulty in meeting obligations associated with
its financial liabilities. The
Company is reliant upon PharmaNet as its sole source of cash. The Company has received financing from
PharmaNet in the past; however, there is no assurance that it will be able to
do so in the future.
14.
Commitment
On 21 June 2013, the Company
executed an agreement with a New York-based company, Dermatology Development
Corporation, to develop and market a range of therapeutic, cosmetic and cosmecutical
products based on the ThermaLIFE® product range and its active ingredient
in the United States.
15.
Subsequent Event
There are no reportable
events for the period from the six month period ended 31 December 2013 to the
date that the interim consolidated financial statements were available to be
issued.
19
Item 2.
Management’s Discussion and Analysis
of Financial Condition and Results of Operations.
THE FOLLOWING ANALYSIS OF THE RESULTS OF
OPERATIONS AND FINANCIAL CONDITION OF MOLECULAR USA FOR THE SECOND QUARTER PERIOD
ENDED DECEMBER 31, 2013 AND SHOULD BE READ IN CONJUNCTION WITH MOLECULAR
USA’S INTERIM CONSOLIDATED FINANCIAL STATEMENTS, INCLUDING THE NOTES
THERETO CONTAINED ELSEWHERE IN THE FORM 10-Q.
Our interim consolidated financial statements are
stated in United States Dollars and are prepared in accordance with United
States Generally Accepted Accounting Principles (
"
U.S. GAAP
").
Overview
We were incorporated in the state of Nevada on
May 1, 2002. Up until the fall of 2005, Molecular USA was in the business of
mineral exploration and development of a mineral property.
On
October 13, 2005, Molecular USA entered into a distribution and supply
agreement with Molecular
Pharmacology Pty. Ltd. (formerly Molecular
Pharmacology Limited) ("
MPLA
"). MPLA
is incorporated under the laws of Australia and at the time was a wholly owned
subsidiary company of PharmaNet Group Limited ("
PharmaNet
"), an Australian company listed on the Australian Stock Exchange. Under
the terms of the distribution and supply agreement, Molecular USA received the
exclusive distribution rights to distribute, market, promote, detail, advertise
and sell certain "
Licensed Products
",
as defined in the agreement, with metallo-polypeptide analgesic as an active
ingredient, in the United States (excluding its territories and
possessions).
On May 9, 2006, Molecular USA announced that it
has acquired 100% of the issued and outstanding share capital of MPLA. The
transaction was originally announced by Molecular USA in a press release dated
November 29, 2005 and was subsequently approved by a majority of the
stockholders of the Company at a stockholders meeting held on April 21, 2006.
As a result of the transaction, PharmaNet, the former parent company of MPLA,
now controls approximately 79% of Molecular USA's issued and outstanding share
capital. The transaction between the parties closed in escrow with an effective
closing date of May 8, 2006. The business of MPLA is now the business of
Molecular USA.
On July 19, 2013, Molecular USA announced its
wholly-owned subsidiary, MPLA, executed an agreement with a New York-based
company, Dermatology Development Corporation ("
DDC
") to develop and market a range of therapeutic,
cosmetic and cosmecutical products based on the ThermaLIFE® product range
and its active ingredient in the United States.
Under the terms of the agreement, DDC is
contracted to drive business relationships with a number of third party
entities to sell products predominantly in the dermatology and cosmetic fields
in the United States in return for an establishment fee and royalties on the
agreements executed as a result of DDC’s services, paid for a fixed
period net of MPLA’s costs of sales. The engagement of DDC is limited to
the provision of the services in the United States, and is for an initial one
year period which may be extended by mutual agreement between MPLA and DDC.
Our Current Business
Molecular USA, through its wholly owned
subsidiary MPLA, is in the business of developing and commercializing a new
analgesic and anti-inflammatory molecule known as Tripeptofen. Tripeptofen is
likely to appear in a new group of products suitable for the treatment of
common every-day pain. As an analgesic and anti-inflammatory drug, Tripeptofen
is unusual due to its rapid speed of action and its topical or rub-on
application.
The majority of over-the-counter anti-pain and
anti-inflammatory products sold for the treatment of acute localized pain are
based on non-steroidal anti-inflammatory drugs or NSAIDs. The majority of such
products are slow acting and provide only mild pain relief.
20
The NSAID group has come under additional
pressure and increasing medical alarm, as many drugs in this class have been
found to set-back the recovery of certain conditions and treatments for which
they were marketed. Moreover, NSAIDs are associated with severe
gastro-intestinal side-effects. This has left a niche in an industry
under-served by new products and ingredients.
MPLA's business strategy is to exploit the fast
and locally acting, low side effects, and recovery-enhancing properties of its
new drug group and to market this as a new ingredient, enabling pharmaceutical
companies to develop and market effective and safer products suited to a broad
range of common everyday pain.
Licensed Products
Molecular USA has exclusive distribution rights
to distribute, market, promote, advertise and sell certain Licensed Products,
with metallo-polypeptide analgesic and anti-inflammatory activity as an active
ingredient, in the United States (excluding its territories and possessions)
from its wholly owned subsidiary company MPLA.
The Licensed Products include all products in all
dosage forms, formulations, line extensions and package configurations using or
otherwise incorporating any aspect or production method of metallo-polypeptide
analgesic and anti-inflammatory activity as an active ingredient marketed by
MPLA or its affiliates under the trade name Tripeptofen or any other trade
names or trademarks used by MPLA relating to the product and any improvements
to such formulations or dosages as may hereafter be distributed by MPLA or its
affiliates in the territory during the term of the distribution and supply
agreement between Molecular USA and MPLA for the topical application for human
use only, and specifically excludes:
·
|
dermatological or cosmetic use, or tissue repair or tissue regeneration
effect;
|
·
|
any use or application of the Licensed Product in non-human groups or
species; and
|
·
|
Thermalife cream, presently owned by PharmaNet, the holding corporation
of MPLA.
|
All Licensed Products must first obtain
regulatory clearance in the United States before they may be marketed and sold
by Molecular USA in that territory. Clinical programs are currently planned by
MPLA for Europe, USA and Australia. The clinical trial program is expected to
be expanded with follow-up trials. Regulatory approval, commencement of the
Master Drug File ("
MDF
") and
market approval are the focus of an ongoing program expected to continue over
the next 18 to 24 months.
MPLA has an exclusive license from Cambridge
Scientific Pty Ltd. ("
Cambridge
Scientific
") of Australia. This license is restricted
to a "field of use" defined in the license documentation. Cambridge
Scientific may grant other licenses to third parties outside the "field of
use" the subject of the licenses granted to MPLA.
Patents &
Trademarks
Molecular USA and its subsidiary MPLA, regard
their intellectual property rights, such as copyrights, trademarks, trade
secrets, practices and tools, as important to the success of their company. To
protect their intellectual property rights, Molecular USA relies on a
combination of patent, trademark and copyright law, trade secret protection,
confidentiality agreements and other contractual arrangements with their
employees, affiliates, clients, strategic partners, acquisition targets and
others. Effective patent, trademark, copyright and trade secret protection may
not be available in every country in which the combined company intends to
offer its products. The steps taken by Molecular USA and MPLA to protect their
intellectual property rights may not be adequate. Third parties may infringe or
misappropriate the combined company's intellectual property rights or the
combined company may not be able to detect unauthorized use and take
appropriate steps to enforce its rights. In addition, other parties may assert
infringement claims against the combined company. Such claims, regardless of
merit, could result in the expenditure of significant financial and managerial
resources. Further, an increasing number of patents are being issued to third
parties regarding these processes. Future patents may limit the combined
company's ability to use processes covered by such patents or expose the
combined company to claims of patent infringement or otherwise require the
combined company to seek to obtain related licenses. Such licenses may not be
available on acceptable terms. The failure to obtain such licenses on
acceptable terms could have a negative effect on the combined company's
business.
21
To protect their
intellectual property rights, MPLA relies on a combination of license and
patent applications held by
Cambridge
Scientific which includes
"Analgesic and Anti-Inflammatory Composition" comprising USA patent
application in completion plus PCT Provisional Specification having the same
name designated as Serial No. 11/059580.
These patent
applications embody all the current Analgesic and Anti-inflammatory assets.
MPLA will also rely on the exclusive nature of its license, trademark and
copyright law, trade secret protection, confidentiality agreements and other
contractual arrangements as it may execute from time to time.
Management of Molecular USA and MPLA believes that MPLA's products,
trademarks, and other proprietary rights do not infringe on the proprietary
rights of third parties.
Marketing
Molecular USA plans to market its Licensed
Products, when approved, through existing pharmaceutical distributors and by
collaborative dealings with major companies active in the United States and
Europe.
In addition, Molecular USA plans to explore
opportunities for direct sales, out-licensing and the integration of the
company’s proprietary anti-inflammatory and analgesic components in
products already distributed through various international markets.
Molecular USA expects that these activities may
even help fund the development costs of the Licensed Products in the United
States.
Manufacturing &
Supply
Molecular USA and MPLA have no manufacturing
facilities. MPLA is required to supply Molecular USA with all Licensed Products
under the distribution and supply agreement entered into by the parties in
October 2005. It is likely MPLA will enter into arrangements with various Good
Manufacturing Practice ("
GMP
") certified
formulation and manufacturers of the Licensed Products for clinical trial and
sales purposes. These formulations and the manufacturing facilities must comply
with regulations and Current Good Laboratory Practices (
"
CGLP
"), and current GMPs,
enforced by the Food and Drug Administration ("
FDA
").
Molecular USA plans to continue
MPLA's practice to outsource formulation and manufacturing for its clinical
trials and potential commercialization after the acquisition of MPLA by
Molecular USA.
Molecular USA has not entered into any supply
agreements.
Competition
Molecular USA and MPLA compete in the segment of
the pharmaceutical market that treats pain and inflammation, which is highly
competitive. We face significant competition from most pharmaceutical companies
as well as biotechnology companies that are also researching and selling
products designed to treat pain and inflammation. Many of our competitors have
significantly greater financial, manufacturing, marketing and product
development resources than we do. Large pharmaceutical companies in particular have
extensive experience in clinical testing and in obtaining regulatory approvals
for drugs. These companies also have significantly greater research
capabilities than we do. In addition, many universities and private and public
research institutes are active in neurological research, some in direct
competition with us. These companies, as well as academic institutions,
governmental agencies and other public and private organizations conducting
research, also compete with Molecular USA and MPLA in recruiting and retaining
highly qualified scientific personnel and consultants and may establish
collaborative arrangements with competitors of Molecular USA.
Molecular USA's competition will be determined in
part by the potential indications for which the MPLA's products are developed
and ultimately approved by regulatory authorities.
22
Molecular USA knows of other companies and
institutions dedicated to the development of anti-pain and anti-inflammatory
pharmaceuticals similar to those being developed by MPLA and licensed to
Molecular USA. Many of Molecular USA's competitors, existing or potential, have
substantially greater financial and technical resources and therefore may be in
a better position to develop, manufacture and market pharmaceutical products. Many
of these competitors are also more experienced with regard to preclinical
testing, human clinical trials and obtaining regulatory approvals. The current
or future existence of competitive products may also adversely affect the
marketability of Molecular USA's products.
Governmental Regulation
FDA Regulation
. Pharmaceutical products are subject to
extensive pre- and post-marketing regulation by the FDA, including regulations
that govern the testing, manufacturing, safety, efficacy, labeling, storage,
record-keeping, advertising and promotion of the products under the Federal
Food, Drug and Cosmetic Act and the Public Health Services Act, and by
comparable agencies in most foreign countries. The process required by the FDA
before a new drug may be marketed in the United States generally involves the
following: completion of pre-clinical laboratory and animal testing; submission
of an investigational new drug application ("
IND
"), which must become effective before clinical
trials may begin; performance of adequate and well controlled human clinical
trials to establish the safety and efficacy of the proposed drug’s
intended use; and approval by the FDA of a New Drug Application ("
NDA
").
The activities required before a pharmaceutical
agent may be marketed in the United States begin with pre-clinical testing. Pre-clinical
tests include laboratory evaluation of potential products and animal studies to
assess the potential safety and efficacy of the product and its formulations.
The results of these studies and other information must be submitted to the FDA
as part of an IND application, which must be reviewed and approved by the FDA
before proposed clinical testing can begin. Clinical trials involve the
administration of the investigational new drug to healthy volunteers or to
patients under the supervision of a qualified principal investigator. Clinical
trials are conducted in accordance with Good Clinical Practices under protocols
that detail the objectives of the study, the parameters to be used to monitor
safety and the efficacy criteria to be evaluated. Each protocol must be
submitted to the FDA as part of the IND application. Further, each clinical
study must be conducted under the auspices of an independent institutional
review board. The institutional review board will consider, among other things,
ethical factors and the safety of human subjects.
Typically, human clinical trials are conducted in
three phases that may overlap. In Phase 1, clinical trials are conducted with a
small number of subjects to determine the early safety profile and pharmacology
of the new therapy. In Phase 2, clinical trials are conducted with groups of
patients afflicted with a specific disease in order to determine preliminary
efficacy, optimal dosages and expanded evidence of safety. In Phase 3, large
scale, multicenter, comparative clinical trials are conducted with patients
afflicted with a target disease in order to provide enough data for the
statistical proof of efficacy and safety required by the FDA and others.
The results of the pre-clinical and clinical
testing, together with chemistry and manufacturing information, are submitted
to the FDA in the form of an NDA for a pharmaceutical product in order to
obtain approval to commence commercial sales. In responding to an NDA, the FDA
may grant marketing approvals, request additional information or further
research, or deny the application if it determines that the application does
not satisfy its regulatory approval criteria. Patient-specific therapies may be
subject to additional risk with respect to the regulatory review process. FDA
approval for a pharmaceutical product may not be granted on a timely basis, if
at all, or if granted may not cover all the clinical indications for which
approval is sought or may contain significant limitations in the form of
warnings, precautions or contraindications with respect to conditions of use.
Satisfaction of FDA premarket approval
requirements for new drugs typically takes several years, and the actual time
required may vary substantially based upon the type, complexity and novelty of
the product or targeted disease. Government regulation may delay or prevent
marketing of potential products for a considerable period of time and impose
costly procedures upon our activities. Success in early stage clinical trials
or with prior versions of products does not assure success in later stage
clinical trials. Data obtained from clinical activities are not always
conclusive and may be susceptible to varying interpretations that could delay,
limit or prevent regulatory approval.
23
Once approved, the FDA may withdraw the product
approval if compliance with pre- and post-marketing regulatory standards is not
maintained or if problems occur after the product reaches the marketplace. In
addition, the FDA may require post-marketing studies, referred to as Phase 4
studies, to monitor the effect of an approved product, and may limit further
marketing of the product based on the results of these post-market studies. The
FDA has broad post-market regulatory and enforcement powers, including the
ability to levy fines and civil penalties, suspend or delay issuance of
approvals, seize or recall products, or withdraw approvals.
Facilities used to manufacture drugs are subject
to periodic inspection by the FDA, Drug Enforcement Agency and other
authorities where applicable, and must comply with the FDA’s Current Good
Manufacturing regulations. Failure to comply with the statutory and regulatory
requirements subjects the manufacturer to possible legal or regulatory action,
such as suspension of manufacturing, seizure of product or voluntary recall of
a product. Adverse experiences with the product must be reported to the FDA and
could result in the imposition of market restriction through labeling changes
or in product removal. Product approvals may be withdrawn if compliance with
regulatory requirements is not maintained or if problems concerning safety or
efficacy of the product occur following approval.
With respect to post-market product advertising
and promotion, the FDA imposes a number of complex regulations on entities that
advertise and promote pharmaceuticals, which include, among other things,
standards and regulations relating to direct-to-consumer advertising, off-label
promotion, industry sponsored scientific and educational activities, and promotional
activities involving the Internet. The FDA has very broad enforcement authority
under the Federal Food, Drug and Cosmetic Act, and failure to abide by these
regulations can result in penalties including the issuance of a warning letter
directing the entity to correct deviations from FDA standards, a requirement
that future advertising and promotional materials be pre-cleared by the FDA,
and state and federal civil and criminal investigations and prosecutions.
Research facilities are subject to various laws
and regulations regarding laboratory practices, the experimental use of
animals, and the use and disposal of hazardous or potentially hazardous
substances in connection with the research in question. In each of these areas, as above, the
government has broad regulatory and enforcement powers, including the ability
to levy fines and civil penalties, suspend or delay issuance of approvals,
seize or recall products, and withdraw approvals, any one or more of which
could have a material adverse effect upon us.
Other Government Regulations
. In addition to laws and regulations
enforced by the FDA, research of Molecular USA’s products in the United
States are subject to regulation under National Institutes of Health
guidelines, as well as under the Controlled Substances Act, the Occupational
Safety and Health Act, the Environmental Protection Act, the Toxic Substances
Control Act, the Resource Conservation and Recovery Act and other present and
potential future federal, state or local laws and regulations, as research and
development of its products involves the controlled use of hazardous materials,
chemicals, viruses and various radioactive compounds.
In addition to regulations in the United States,
Molecular USA’s products are subject to a variety of foreign regulations
governing clinical trials and commercial sales and distribution of its Licensed
Products. Whether or not Molecular USA obtains FDA approval for a product,
Molecular USA or its subsidiaries must obtain approval of a product by the comparable
regulatory authorities of foreign countries before it can commence clinical
trials or marketing of the product in those countries. The approval process
varies from country to country, and the time may be longer or shorter than that
required for FDA approval. The requirements governing the conduct of clinical
trials, product licensing, pricing and reimbursement vary greatly from country
to country.
Sarbanes-Oxley Act of 2002
. On July 30, 2002, President Bush signed
into law the Sarbanes-Oxley Act of 2002 ("
SOA
"). The SOA imposes a
wide variety of new requirements on both United States and non-United States
companies, that file or are required to file periodic reports with the SEC
under the Securities Exchange Act of 1934. Many of these new requirements will
affect Molecular USA and its board of directors. For instance, under the SOA
Molecular USA is required to:
·
|
form an audit committee in compliance with the SOA;
|
·
|
ensure Molecular USA
'
s chief executive officer and
chief financial officer are required to certify its financial statements;
|
24
·
|
ensure Molecular USA’s directors and senior officers are required
to forfeit all bonuses or other incentive-based compensation and profits
received from the sale of Molecular USA’s securities in the twelve month
period following initial publication of any of Molecular USA’s financial
statements that later require restatement;
|
·
|
disclose any off-balance sheet transactions as required by the SOA;
|
·
|
prohibit all personal loans to directors and officers;
|
·
|
ensure directors, officers and 10% holders file their Forms 4's within
two days of a transaction;
|
·
|
adopt a code of ethics and file a Form 8-K whenever
there is a change or waiver of this code; and
|
·
|
ensure Molecular USA
'
s auditor is independent as defined by the SOA.
|
The SOA has required us to review our current
procedures and policies to determine whether they comply with the SOA and the
new regulations promulgated thereunder. We will continue to monitor our
compliance with all future regulations that are adopted under the SOA and will
take whatever actions are necessary to ensure that we are in compliance.
Environmental Compliance
The nature of Molecular USA's and MPLA's business does not require special environmental or local
government approval. Molecular USA and MPLA are compliant with all
environmental laws. The cost of such compliance is minimal for the company.
Employees
In the period ended December 31, 2013, Molecular USA did
not have any employees and does not intend to hire any employees in the
upcoming year. We rely heavily on outside contractors to conduct our business.
Immediate Business
Plans
The Company, through its subsidiary MPLA, plans
to continue to pursue the various levels of the international regulatory
approval processes. Applications and product opportunities for Tripeptofen are
believed to be broad and cover a range of commercial fields, each with distinct
pre-market requirements. The international drug development team, global
resources and local know-how will allow MPLA to seek the most time and cost
effective regulatory pathways for each product and market sector.
On commercial development, MPLA will focus on
consolidating the regulatory pathway work in order to prioritize the path to
market. Jeffrey Edwards will work to set-out the strategies designed to
maximize the multi-jurisdictional capabilities of MPLA's development teams.
Reports to Security Holders
We are required to file annual reports on Form
10-K and quarterly reports on Form 10-Q with the SEC on a regular basis, and
will be required to timely disclose certain material events (e.g., changes in
corporate control; acquisitions or dispositions of a significant amount of
assets other than in the ordinary course of business; and bankruptcy) in a
current report on Form 8-K.
Although our Internet site www.mpl-usa.com does
not contain our reports, you may read and copy any materials we file with the SEC
at their Public Reference Room at 450 Fifth Street, N.W., Washington, D.C.
20549. You may obtain information on the operation of the Public Reference Room
by calling the SEC at 1-800-SEC-0330. Additionally, the SEC maintains an
Internet site (http://www.sec.gov) that contains reports, proxy and information
statements and other information regarding issuers that file electronically
with the SEC.
Results of Operation
For the quarter
ended December 31, 2013.
25
Rev
enues
REVENUE
–
Molecular USA has not generated any
revenues for the quarter ended December 31, 2013, or since inception.
COMMON
STOCK
–
Molecular USA has not
issued any shares during the most recent quarter. As of the date of February 11, 2014,
Molecular USA has 111,553,740 common shares issued and outstanding.
Expenses
SUMMARY
– Total expenses were $63,327 for the six
month period ended December 31, 2013. Expenses had decreased during this past six
month period as compared to the six month period ended December 31, 2012
– $100,170. A total of $2,409,423 in expenses has been incurred by
Molecular USA since inception on
July 14, 2004
through to December 31, 2013. The decrease in costs over
this six month period has occurred as the result of Molecular USA’s
wholly owned subsidiary decreasing in its consulting fees. The costs can be
subdivided into the following categories:
-
Office Expenses and Rent
: $15,170 in
office expenses (for administrative costs) were incurred for the six month
period ended
December 31, 2013,
as compared to $15,780
for the six month period ended December 31, 2012, while a total of $262,031
was incurred in the period from inception on
July
14, 2004
to December 31, 2013. All contributed expenses are reported as
contributed costs with a corresponding credit to additional paid-in
capital.
-
Consulting and Analysis
Costs
: Molecular USA relies on consultants and other third parties to
conduct the majority of its research. For the six month period ended December
31, 2013, $23,467 in consulting and analysis expenses were incurred as
compared to $64,118 during the six month period ended
December
31, 2012.
We have incurred
a total of $1,447,831 in consulting and analyst fees since our inception
on
July 14, 2004
to
December 31, 2013
.
-
Advertising and Promotion
Fees
: Molecular USA has spent no money in this area this year. During
the six month period ended
December
31, 2013,
we spent $Nil on advertising and public relations and $Nil for six month
period ended December 31, 2012. A total of $23,739 has been incurred in
this area during the period from inception on
July
14, 2004
to
December 31, 2013
.
-
Professional Fees
: Molecular USA
incurred $21,044 in professional fees for the six month period ended on December
31,
2013,
as compared to $19,743
for the six month period ended December 31, 2012. From inception to
December 31, 2013,
we have incurred
a total of $426,581 professional fees mainly spent on legal and accounting
matters.
-
Travel Costs
: Molecular USA
incurred $Nil in travel costs for the six month period ended December 31,
2013, as compared to $359 for the six month period ended December 31, 2012
and
$111,710 has been incurred in the period
from inception on
July 14, 2004
to
December
31, 2013
.
-
Salaries and Benefit
Costs
: Molecular USA and its subsidiary rely primarily on outside
consultants and not salaried employees. As a result, Molecular USA
incurred $Nil in salaries and benefits for the six month period ended December
31, 2013 and $Nil in salaries and benefits during the six month period
ended December 31, 2012. For the period
July 14, 2004
(inception) through
December 31, 2013
, Molecular USA
has spent a total of $44,464 on salaries and benefits.
Molecular USA
continues to carefully control its expenses and overall costs as it moves
forward with the development of its new business plan. Molecular USA does not
have any employees and engages personnel through outside
consulting
contracts or agreements or other such arrangements.
Income Tax Provision
: We have losses carried-forward for income tax purpose to December 31,
2013. There are no current or deferred
tax
expenses for the six month period ended December 31, 2013, due to our loss
position. We have fully reserved for any benefits of these losses. The deferred
tax consequences of temporary differences in reporting items for financial
statement and income tax purposes are recognized as appropriate.
26
Liquidity and Capital Resources
During the six month period ended December 31, 2013, Molecular USA satisfied
its working capital needs by borrowing cash from its parent company PharmaNet.
As December 31, 2013, the Company had cash and cash equivalents on hand in the
amount of $4,997
(
June 30, 2013 - $7,046) and current payable and accrued
liabilities of $20,482 (
June 30, 2013 - $21,628
). As December 31, 2013, Molecular
USA currently owes its parent company PharmaNet, $2,004,134
,
an additional $47,845
to other related parties, and $20,482 to non-related parties. Given the
proposed business activities of Molecular USA and its subsidiary, Management
does not expect that the current level of cash on hand will be sufficient to
fund its operation for the next twelve month period.
To achieve our goals and objectives for the next
12 months, we plan to raise additional capital through private placements of
our equity securities and future financing from our majority shareholder PharmaNet.
We plan to use any additional funds that we might
be successful in raising for development, as well as for strategic acquisition
of existing businesses that complement our market niche, and general working
capital purposes.
If we are unsuccessful in obtaining new capital,
our ability to seek and consummate strategic acquisitions to build our company internationally
and to expand of our business development and marketing programs could be
adversely affected.
Off-Balance Sheet
Arrangement
As of December
31, 2013,
Molecular USA did not have any off-balance sheet arrangements.
Research and Development
Since the acquisition of MPLA, Molecular USA has maintained
MPLA’s research and development program to:
·
|
Refine and prove-up its proprietary active
ingredients and to commence the processes that will lead to the issue of a
Master Drug File registration of its products;
|
·
|
Define the mode of action and potential of
Tripeptofen in both in vitro, animal and human studies;
|
·
|
Gain Australian regulatory and marketing
approval;
|
·
|
Gain European regulatory approval; and
|
·
|
Commence application for American regulatory
approval.
|
MPLA is in the business of developing and
commercializing a new analgesic and anti-inflammatory molecule known as
Tripeptofen. Tripeptofen is likely to appear in a new group of products
suitable for the treatment of common every-day pain. As an analgesic and
anti-inflammatory drug, Tripeptofen is unusual due to its rapid speed of action
and its topical or rub-on application.
On April 19, 2006, Molecular USA announced the filing of a new patent,
Tissue Disruption Treatment and Composition for Use (US Patent number
11218382). The patent describes a proprietary process for the manufacture of
topical biological secondary injury mediators ("
B-SIMs
")
that should have local, rather than systemic, effects and may be significantly
less expensive to manufacture than conventional B-SIMs. MPLA is developing its
B-SIMs to stop the tissue disruption that occurs after injury by suppressing
the body's reactions, such as inflammation and damage/death of otherwise
uninjured cells that are triggered in response to primary injury.
The first conditions targeted by MPLA will be the
musculoskeletal injuries. The use of a B-SIM in these markets represents a new
approach to one of the world’s largest over the counter drug markets and
includes indications such as joint inflammation, musculoskeletal pain, overuse
and strain injuries, burns and even surgical and cosmetic procedures.
MPLA’s proprietary, industrially scalable peptide-ligand bond exchange ("
PLBE
") B-SIM manufacturing process involves the
disassociation of proteins, rather than the far more costly process of
assembling B-SIMs one sequence at a time. The patent was lodged in the name of
Cambridge Scientific; however, Molecular USA holds the worldwide exclusive license to
manufacture, commercialize, market and distribute topical anti-inflammatory and
analgesic products based on the proprietary MPL-TL compound.
27
Molecular USA is still working on the projections
regarding the necessary expenditure and time frame involved in pursuing this
research and development program. Any such program will also be subject to
Molecular USA raising the necessary funds to advance such a program.
Capital Expenditure
Commitments
Capital expenditures for the six month period
ended December 31, 2013, amounted to $Nil. Molecular USA does not anticipate
any significant purchase or sale of equipment over the next 12 months.
Recent Accounting
Pronouncements
Certain
new
standards, interpretations, amendments and improvements to existing standards
were issued by FASB. The new standards, amendments to standards and
interpretations that have been issued and that are applicable to the Company
but not effective during the six month period ended December 31, 2013 are as
follows:
In July 2013, the FASB
issued ASU 2013-11, "
Income Taxes (Topic 740):
Presentation of an Unrecognized Tax Benefit When a Net Operating Loss
Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exist
".
These amendments require that an unrecognized tax benefit, or a portion of an
unrecognized tax benefit, should be presented in the financial statements as a
reduction to a deferred tax asset for a net operating loss carryforward, a
similar tax loss, or a tax credit carryforward except as follows. To the extent
a net operating loss carryforward, a similar tax loss, or a tax credit
carryforward is not available at the reporting date under the tax law of the
applicable jurisdiction to settle any additional income taxes that would result
from a disallowance of a tax position or the tax law of the applicable
jurisdiction does not require the entity to use, and the entity does not intend
to use, the deferred tax asset for such purpose, the unrecognized tax benefit
should be presented in the financial statements as a liability and should not
be combined with deferred tax assets. These amendments are effective for fiscal
years, and interim periods within those years, beginning after December 15,
2013. The amendments should be applied prospectively to all unrecognized tax
benefits that exist at the effective date. Retrospective application and early
adoption is permitted. The adoption is not expected to have a material impact
on the Company’s consolidated financial statements.
Changes in Accounting Policies
Effective
July 1, 2013, the Company adopted ASU 2013-05, "
Foreign
Currency Matters (Topic 830) – Parent’s Accounting for the
Cumulative Translation Adjustment upon Derecognition of Certain Subsidiaries or
Group of Assets within a Foreign Entity or of an Investment in a Foreign Entity
".
These amendments provide guidance on releasing cumulative translation
adjustments when a reporting entity (parent) ceases to have a controlling
financial interest in a subsidiary or a group of assets that is a non-profit
activity or a business within a foreign entity. In addition, these amendments
provide guidance on the release of cumulative translation adjustments in
partial sales of equity method investments and in step acquisitions. The
adoption of these amendments did not have an impact on the Company’s
interim consolidated financial statements.
Effective
July 1, 2013, the Company adopted ASU 2013-04, "
Liabilities
(Topic 405) – Obligations Resulting from Joint and Several Liability
Arrangements for Which the Total Amount of the Obligation is Fixed at the
Reporting Date
". These amendments provide guidance for the
recognition, measurement, and disclosure of obligations resulting from joint
and several liability arrangements for which the total amount of the obligation
within the scope of this guidance is fixed at the reporting date, except for
obligations addressed within existing guidance in U.S. GAAP. The adoption of
these amendments did not have an impact on the Company’s interim
consolidated financial statements.
Effective
July 1, 2013, the Company adopted ASU 2013-02, "
Comprehensive
Income (Topic 220) – Reporting of Amounts Reclassified out of Accumulated
Other Comprehensive Income
". The amendments require an entity
to provide information about the amounts reclassified out of accumulated other
comprehensive income by component.
In addition, an entity is required to present, either on the face of the
statement where net income is presented or in the notes, significant amounts
reclassified out of accumulated other comprehensive income by the respective
line items of net income but only if the amount reclassified is required under
U.S. GAAP to be reclassified to net income in its entirety in the same reporting
period. For other amounts that are not required under U.S. GAAP to be
reclassified in their entirety to net income, an entity is required to cross
reference to other disclosures required under U.S. GAAP that provide additional
details about those amounts. The adoption of these amendments did not have an
impact on the Company’s interim consolidated financial statements.
28
Critical Accounting Policies and Estimates
Our quarterly interim consolidated financial
statements and accompanying notes are prepared in accordance with U.S. GAAP
used in the United States. Preparing financial statements requires Management
to make estimates and assumptions that affect the reported amounts of assets,
liabilities, revenue, and expenses. These estimates and assumptions are affected
by Management's application of accounting policies. We believe that
understanding the basis and nature of the estimates and assumptions involved
with the following aspects of our interim consolidated financial statements is
critical to an understanding of our financials.
Stock-Based Compensation
Effective
January 1, 2006, the Company adopted the provisions of ASC 718,
"Compensation – Stock Compensation"
, which
establishes accounting for equity instruments exchanged for employee services.
Under the provisions of ASC 718, stock-based compensation cost is measured at
the grant date, based on the calculated fair value of the award, and is
recognized as an expense over the employees’ requisite service period
(generally the vesting period of the equity grant). The Company adopted ASC 718
using the modified prospective method, which requires the Company to record
compensation expense over the vesting period for all awards granted after the
date of adoption, and for the unvested portion of previously granted awards
that remain outstanding at the date of adoption. Accordingly, the financial
statements for the periods prior to January 1, 2006 have not been restated to
reflect the fair value method of expensing share-based compensation. The
adoption of ASC 718 does not change the way the Company accounts for
share-based payments to non-employees, with guidance provided by ASC 505-50,
"Equity-Based Payments to Non-Employees".
Item 3. Quantitative and
Qualitative Disclosures about Market Risk.
Interest Rate Risk
Due to the short-term nature of our interest
bearing assets, which consist primarily of cash and cash equivalents and no restricted
cash, we believe that our exposure to interest rate market risk will not
significantly affect our operations.
Foreign Currency Risk
Our head office and lab operations are based in
Australia. Accordingly, we have been subject to exposure from adverse movements
in foreign currency exchange rates. To date, the effect of changes in foreign
currency exchange rates on revenue and operating expenses has not been material
as we have had no revenue and limited operations. Operating expenses incurred by
our foreign subsidiaries were denominated in local currencies. We have not used
financial instruments to hedge these operating expenses.
Item 4. Controls and
Procedures.
(a) Evaluation of disclosure
controls and procedures
Disclosure controls are controls and procedures that are designed to
ensure that information required to be disclosed in our reports filed 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 a company in the reports that it files or submits
under the Exchange Act is accumulated and communicated to the company's Management,
including its principal executive and principal financial officers, or persons
performing similar functions, as appropriate to allow timely decisions
regarding required disclosure.
29
Management carried out an evaluation (with the participation of our
Chief Executive Officer ("
CEO
")
and Chief Financial Officer ("
CFO
")
), of the effectiveness of the design and operation of our disclosure controls
and procedures pursuant to Rules 13a-15(e) and 15d-15(e) under the Securities
Exchange Act of 1934 ("
Exchange
Act
"). Based upon that
evaluation, the Company's CEO and CFO have concluded that the Company's
disclosure controls and procedures were effective as of December 31, 2013.
(b) Internal control
over financial reporting
Management's annual report on
internal control over financial reporting
Management is responsible for establishing and maintaining adequate
internal control over financial reporting as defined in Rules 13a-15(f) and
15d-15(f) under the Exchange Act. Our internal control over financial reporting
is intended to provide reasonable assurance
regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in accordance
with U.S. GAAP. Our internal control over financial reporting should include
those policies and procedures that:
·
|
pertain to the maintenance of
records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of our assets;
|
·
|
provide reasonable assurance that
transactions are recorded as necessary to permit preparation of financial statements
in accordance with applicable U.S.
GAAP, and that receipts and expenditures are being made only in accordance with
authorizations of Management and the Board of Directors; and
|
·
|
provide reasonable assurance
regarding prevention or timely detection of unauthorized acquisition, use or
disposition of our assets that could have a material effect on the financial
statements.
|
Because of its inherent limitations, internal control over financial
reporting may not prevent or detect misstatements. Also, projections of any
evaluation of effectiveness to future periods are subject to the risk that
controls may become inadequate
because of changes in conditions, or that the degree of compliance with the
policies or procedures may deteriorate.
As required by Rule 13a-15(c) promulgated under the Exchange Act, Management,
with the participation of our CEO and CFO, evaluated the effectiveness of our
internal control over financial reporting as of December 31, 2013. Management's
assessment took into consideration the size and complexity of the company and
was based on criteria set forth by the Committee of Sponsoring Organizations of
the Treadway Commission in Internal Control over Financial Reporting - Guidance
for Smaller Public Companies. In performing the assessment, Management has
concluded that our internal control over financial reporting was effective as
of December 31, 2013.
Attestation report of the registered public accounting firm
This quarterly report does not include an attestation report of the Company's
registered public accounting firm regarding internal control over financial
reporting. Management's report was not subject to attestation by the Company's
registered public accounting firm pursuant to temporary rules of the SEC that
permit the Company to provide only Management's report in this quarterly
report.
Changes in internal control over financial reporting
Based on the evaluation as of December 31, 2013, Jeffrey Edwards, our
President, CEO, and CFO has concluded that there were no significant changes in
our internal controls over financial reporting or in any other areas that could significantly affect our internal controls subsequent to the date
of his most recent evaluation, including corrective actions with regard to
significant deficiencies and material weaknesses.
30