MANAGEMENT’S DISCUSSION AND
ANALYSIS
April
13, 2009
CAUTION
REGARDING FORWARD-LOOKING STATEMENTS
This
management discussion and analysis may contain forward-looking statements within
the meaning of Canadian and U.S. securities laws. Such statements
include, but are not limited to, statements relating
to:
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our
ability to repay or refinance our convertible debentures at
maturity;
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our
ability to obtain the substantial capital required to fund research and
operations;
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our
plans to obtain partners to assist in the further development of our
product candidates;
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our
expectations with respect to existing and future corporate alliances and
licensing transactions with third parties, and the receipt and timing of
any payments to be made by us or to us in respect of such arrangements,
and
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our
expectations regarding future
financings;
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our
plans to conduct clinical
trials;
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our
expectations regarding the progress and the successful and timely
completion of the various stages of our drug discovery, pre-clinical and
clinical studies and the regulatory approval
process;
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the
Company’s plans, objectives, expectations and intentions and other statements
including words such as “anticipate”, “contemplate”, “continue”, “believe”,
“plan”, “estimate”, “expect”, “intend”, “will”, “should”, “may”, and other
similar expressions.
Such
statements reflect our current views with respect to future events and are
subject to risks and uncertainties and are necessarily based upon a number of
estimates and assumptions that, while considered reasonable by us are inherently
subject to significant business, economic, competitive, political and social
uncertainties and contingencies. Many factors could cause our actual results,
performance or achievements to be materially different from any future results,
performance, or achievements that may be expressed or implied by such
forward-looking statements, including, among others:
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our
ability to repay or refinance our convertible debentures at
maturity;
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our
ability to obtain the substantial capital required to fund research and
operations;
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our
lack of product revenues and history of operating
losses;
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our
early stage of development, particularly the inherent risks and
uncertainties associated with (i) developing new drug candidates
generally, (ii) demonstrating the safety and efficacy of these drug
candidates in clinical studies in humans, and (iii) obtaining regulatory
approval to commercialize these drug
candidates;
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the
progress of our clinical
trials;
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our
ability to maintain compliance with the operational covenants of the
convertible debenture agreement that could result in an event of default
and the requirement for early
repayment;
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our
liability associated with the indemnification of Old Lorus and its
directors, officers and
employees
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our
ability to find and enter into agreements with potential
partners;
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our
drug candidates require time-consuming and costly preclinical and clinical
testing and regulatory approvals before
commercialization;
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clinical
studies and regulatory approvals of our drug candidates are subject to
delays, and may not be completed or granted on expected timetables, if at
all, and such delays may increase our costs and could delay our ability to
generate revenue;
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the
regulatory approval
process;
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our
ability to attract and retain key
personnel;
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our
ability to obtain patent protection and protect our intellectual property
rights;
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our
ability to protect our intellectual property rights and to not infringe on
the intellectual property rights of
others;
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our
ability to comply with applicable governmental regulations and
standards;
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development
or commercialization of similar products by our competitors, many of which
are more established and have greater financial resources than we
do;
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commercialization
limitations imposed by intellectual property rights owned or controlled by
third parties;
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our
business is subject to potential product liability and other
claims;
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our
ability to maintain adequate insurance at acceptable
costs;
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further
equity financing may substantially dilute the interests of our
shareholders;
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changing
market conditions;
and
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other
risks detailed from time-to-time in our ongoing quarterly filings, annual
information forms, annual reports and annual filings with Canadian
securities regulators and the United States Securities and Exchange
Commission, and those which are discussed under the heading “Risk
Factors”.
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Should
one or more of these risks or uncertainties materialize, or should the
assumptions set out in the section entitled “Risk Factors” underlying those
forward-looking statements prove incorrect, actual results may vary materially
from those described herein. These forward-looking statements are
made as of the date of this management, discussion and analysis or, in the case
of documents incorporated by reference herein, as of the date of such documents,
and we do not intend, and do not assume any obligation, to update these
forward-looking statements, except as required by law. We cannot
assure you that such statements will prove to be accurate as actual results and
future events could differ materially from those anticipated in such
statements. Investors are cautioned that forward-looking statements
are not guarantees of future performance and accordingly investors are cautioned
not to put undue reliance on forward-looking statements due to the inherent
uncertainty therein.
LIQUIDITY
AND CAPITAL RESOURCES
Since
its inception, Lorus has financed its operations and technology acquisitions
primarily from equity and debt financing, the proceeds from the exercise of
warrants and stock options, and interest income on funds held for future
investment. The remaining costs associated with the completion of the
LOR-2040 Phase I/II clinical trial program with the US National Cancer Institute
(“NCI”) will be borne by the US NCI. Lorus has undertaken an expanded
LOR-2040 trial at its own cost and acquired additional quantities of LOR-2040
drug to support this ongoing trial and any further development of
LOR-2040. We will continue the development of our small
molecule programs from internal resources.
We
have not earned substantial revenues from our drug candidates and are therefore
considered to be in the development stage. The continuation of our
research and development activities and the commercialization of the targeted
therapeutic products are dependent upon our ability to successfully finance and
complete our research and development programs through a combination of equity
financing and payments from strategic partners. We have no current
sources of significant payments from strategic partners. In addition,
we will need to repay or refinance the secured convertible debentures on their
maturity on October 6, 2009 should the holder not choose to convert the
debentures into common shares. We
believe that it is unlikely the holder will chose to convert at $1/share as in
the present agreement. There
can be no assurance that additional funding will be available at all or on
acceptable terms to permit further clinical development of our products or to
repay the convertible debentures on maturity. If we are not able to
raise additional funds, we will not be able to continue as a going concern and
realize our assets and pay our liabilities as they fall
due.
Management
believes that our current level of cash and cash equivalents and short term
investments will be sufficient to execute our current planned operating
expenditures for the next twelve months; however, our $15 million convertible
debt obligation is due in October 2009 and we currently do not have the cash and
cash equivalents to satisfy this obligation. Given
the current market capitalization of the Company it is unlikely that the Company
will be able to raise additional funds to repay this liability which
raises significant doubt related to the Company’s ability to continue as a going
concern and realize its assets and pay its liabilities as they fall
due. If the Company cannot repay or refinance the debentures at or
prior to maturity, the lender may take any action permitted by law to realize on
its security.
The
financial statements do not reflect adjustments that would be necessary if the
going concern assumption were not appropriate. If the going concern basis
were not appropriate for these financial statements, then adjustments would be
necessary in the carrying value of the assets and liabilities, the reported
revenues and expenses and the balance sheet classifications
used.
The
following discussion should be read in conjunction with the audited financial
statements for the year ended May 31, 2008 and the accompanying notes (the
"Financial Statements") contained in the Company’s annual report. The
Financial Statements, and all financial information discussed below, have been
prepared in accordance with Canadian generally accepted accounting principles
(“GAAP”). All amounts are expressed in Canadian dollars unless
otherwise noted. In this MD&A, "Lorus", “New Lorus”, the
"Company', "we", "us" and "our" each refers to Lorus Therapeutics
Inc.
OVERVIEW
Lorus
is a life sciences company focused on the discovery, research and development of
effective anticancer therapies with a high safety profile. Lorus has
worked to establish a diverse anticancer product pipeline, with products in
various stages of development ranging from pre-clinical to an advanced Phase II
clinical trial. A growing intellectual property portfolio supports
our diverse product pipeline. Lorus’ pipeline is a combination of
internally developed products and products licensed in from other entities at a
pre-clinical stage.
We
believe that the future of cancer treatment and management lies in drugs that
are effective, safe and have minimal side effects, and therefore improve a
patient's quality of life. Many of the cancer drugs currently
approved for the treatment and management of cancer are toxic with severe side
effects, and we therefore believe that a product development plan based on
effective and safe drugs could have broad applications in cancer
treatment. Lorus' strategy is to continue the development of our
product pipeline using several therapeutic approaches. Each therapeutic approach
is dependent on different technologies, which we believe mitigates the
development risks associated with a single technology platform. We
evaluate the merits of each product throughout the clinical trial process and
consider commercial viability as appropriate. The most advanced
anticancer drugs in our pipeline, each of which flow from different platform
technologies, are antisense, small molecules and
immunotherapeutics.
Our
business model is to take our product candidates through pre-clinical testing
and into Phase I and Phase II clinical trials. It is our intention to
then partner or co-develop these product candidates after successful completion
of Phase I or II clinical trials. Lorus will give careful
consideration in the selection of partners that can best advance the drug
candidates into a pivotal Phase III clinical trial and, upon successful results,
commercialization. Our objective is to receive cash for milestone
payments and royalties from such partnerships which will support continued
development of our product pipeline. We assess each product candidate
and determine the optimal time to work towards partnering out that product
candidate.
Our
success is dependent upon several factors, including, our ability to repay or
refinance our $15 million convertible debentures, maintaining sufficient levels
of funding through public and/or private financing, establishing the efficacy
and safety of our products in clinical trials and securing strategic
partnerships.
Our
loss from operations for the three and nine months ended February 28, 2009
decreased to $2.5 million ($0.01 per share) and $7.4 million ($0.03 per share),
respectively, compared to $3.8 million ($0.02 per share) and $9.0 million ($0.04
per share) during the same periods in fiscal 2008. During
the nine months ended February 28, 2009 the Company recorded a gain on sale of
shares related to the Arrangement of $450 thousand which resulted in a net loss
and other comprehensive loss of $7.0 million ($0.03 per
share). During the nine month period ended February 29, 2008, the
Company realized a gain on the sale of the shares related to the Arrangement (as
described in the section titled “Plan of Arrangement and Corporate
Reorganization) in the amount of $6.3 million resulting in net loss and other
comprehensive loss for the period of $2.7 million ($0.01 per share).
The
decrease in loss from operations for the three months ended February 28, 2009
compared with the same period last year is due primarily to reduced research and
development spending of $1.2 million, resulting from the completion of toxicity
studies ongoing in Q3 2008 and lower drug manufacturing costs (described below)
as well as lower stock based compensation costs of $106 thousand due to one time
option grants in the third quarter of 2008 compared with no grants in the third
quarter of 2009.
The
decrease in net loss from operations for the nine months ended February 28, 2009
compared with the same period last year is due primarily to lower research and
development costs of $1.3 million resulting from less spending on GLP-toxicity
studies as well as drug manufacturing costs, lower general and administrative
costs of $119 thousand due to reduced legal costs as well as lower stock based
compensation costs of $182 thousand due to one time option grants in the third
quarter of 2008 whereas there were no grants in the third quarter of 2009, and
option modification costs incurred in the second quarter of 2008 offset by lower
interest income of $217 thousand due to lower cash and investment balances and
lower prime rates of interest.
We
utilized cash of $1.8 million in our operating activities in three-month period
ended February 28, 2009 compared with $2.6 million during the same period in
fiscal 2008. The decrease is primarily a result of a reduced net loss
offset by lower accounts payable and accrued liabilities balances in the current
year. We utilized cash of $5.7 million for the nine months ended
February 28, 2009 compared with $7.5 million in the same period last
year. The reduced use of cash is the result of a lower net loss as
well as a reduction in the change in non-cash operating working capital as
compared to the nine months ended February 29, 2008.
At
February 28, 2009, we had cash and cash equivalents and short-term investments
of $7.3 million compared to $9.4 million at May 31,
2008.
Revenues
for the three-month period ended February
28, 2009 increased
to $64 thousand compared with revenue of $3 thousand for the same period last
year. For the nine-month period ended February 28, 2009, total
revenue increased to $106 thousand from $30 thousand in the same period last
year. This increase in revenue is related to an increase in milestone
revenues associated with the license of Virulizin to ZOR Pharmaceuticals and
recognition of revenue on milestone payments received in prior periods. This
revenue
is recognized over the remaining period of a service contract whereby Lorus has
agreed to provide consulting services to ZOR pharmaceuticals. There remains $166
thousand (US $150 thousand) in deferred revenue which has been recorded in
Accrued Liabilities on the balance sheet as at February 28,
2009. Management anticipates that this revenue will be recognizable
over the next nine months as services are
provided.
Research
and development expenses totaled $1.0 million in the three-month period ended
February
28, 2009 compared
to $2.2 million during the same period last year and decreased to $2.9 million
from $4.3 million in the nine month period ended February 28, 2009 as compared
to the same period in fiscal 2008.
The
decrease in spending during the three months ended February 28, 2009 compared
with the prior year is due to GLP-toxicity studies for both our LOR-2040 bladder
cancer and LOR-253 small molecule programs that were ongoing in the third
quarter of 2008 and are now completed. In addition during the third
quarter of 2008 manufacturing of LOR-2040 was ongoing resulting in significant
costs, in the third quarter of 2009 manufacturing of LOR-253, our lead small
molecule is ongoing, however the manufacturing costs of LOR-253 are
significantly less than LOR-2040 contributing to the decrease in
spending.
Research
and development costs for the nine-month period ending February 28, 2009
decreased due to reduced spending on GLP-toxicity studies for both our LOR-253
small molecule and LOR-2040 bladder cancer programs which are now complete,
lower clinical spending due to some Virulizin related costs incurred in the
prior year (all further costs are now borne by our licensee) as well as lower
manufacturing costs for the reasons described above.
General
and Administrative
General
and administrative expenses totaled $822 thousand in the three-month period
ended February
28, 2009 compared
to $863 thousand in same period last year. For the nine month period
ended February 28, 2009, general and administrative expense was $2.6 million
compared with $2.7 million in the same period last
year.
The
slight decrease in general and administrative costs for the three month period
ended February 28, 2009 is the result of reduced legal costs. For the
nine-month period ended February 28, 2009 general and administrative costs
decreased slightly due to lower personnel costs, reduced legal and patent costs
and lower annual meeting costs offset by foreign exchange
losses.
Stock-Based
Compensation
Stock-based
compensation expense totaled $111 thousand in the three-month period ended
February 28, 2009 compared with $217 thousand in the same period last year and
$347 in the nine-month period ended February 28, 2009 compared with $529
thousand for the same period last year.
The
decrease in stock based compensation for the three month period ending February
28, 2009 is due primarily to a one time increase in options granted during the
third quarter of 2008 that immediately vested in order to bring option granting
practices in line with industry standards.
In
addition to the increased option grants described above, the decrease in the
nine month period ending February 28, 2009 is also due to an expense of $83
thousand in the nine-month period ended February 28, 2009 related to the
extension of options to directors not standing for re-election at the Company’s
annual general meeting and Dr. Wright for options granted in his capacity as
President and CEO.
Depreciation
and Amortization
Depreciation
and amortization expenses decreased to $55 thousand in the three-month period
and $141 thousand in the nine-month period ended February 28, 2009 as compared
to $81 thousand and $240 thousand in the same periods, respectively, last
year. The
decrease in depreciation and amortization expense is the result of reduced
capital asset purchases over the past three fiscal
years.
Additions
to capital assets for the nine month period ended February 28, 2009 increased to
$167 thousand compared with $52 thousand for the nine month period ended
February 29, 2008. This increase is due to the one time acquisition
of research and development equipment. This equipment will allow
Lorus to do certain testing in house which was previously
outsourced.
Interest
Expense
Non-cash
interest expense was $160 thousand in the three-month period ended February
28, 2009 compared
with $258 thousand in the same period last year. For the nine-month
period ended February 28, 2009 interest expense was $578 thousand compared with
$799 thousand for the same period last year. These amounts represent
interest at a rate of prime plus 1% on the $15.0 million convertible
debentures. The decrease in interest expense in fiscal 2009 compared
with fiscal 2008 is a function of significantly lower prime rates in comparison
with the prior year. All interest accrued on the debentures to date
has been paid in common shares of the Company.
Accretion
in Carrying Value of Secured Convertible Debentures
Accretion
in the carrying value of the Company’s secured convertible debentures amounted
to $407 thousand in the three-month period ended February
28, 2009 compared
with $320 thousand in the same period last year. For the nine month
period ended February
28, 2009,
accretion charges were $1.2 million compared to $925 thousand in the same period
in fiscal 2008. The accretion charges arise as under GAAP the Company
has allocated the proceeds from each tranche of the debentures to the debt and
equity instruments issued on a relative fair value basis resulting in the $15.0
million debentures having an initial cumulative carrying value of $9.8 million
as of their dates of issuance. Each
reporting period, the Company is required to accrete the carrying value of the
convertible debentures such that at maturity on October 6, 2009, the carrying
value of the debentures will be the face value of $15.0 million. The
increase in expense for the three and nine month periods ending February 28,
2009 compared with the prior year is due to a higher effective rate of interest
and a larger principal balance.
Interest Income
Interest
income totaled $65 thousand in the three-month period ended February
28, 2009 compared
to $120 thousand in the same period last year. For the nine-month
period ended February 28, 2009 interest income totaled $218 thousand compared
with $435 thousand in the same period last year. The decrease in
interest income during both the three and nine month periods ended February 28,
2009 is due to a lower average cash and marketable securities balance and
significantly lower interest rates available on investments in comparison with
the same periods in the prior year.
Loss
from operations for the period
Our
loss from operations for the three and nine months ended February 28, 2009
decreased to $2.5 million ($0.01 per share) and $7.4 million ($0.03 per share),
respectively, compared to $3.8 million ($0.02 per share) and $9.0 million ($0.04
per share) during the same periods in fiscal 2008. During the nine months ended
February 28, 2009 the Company recorded a gain on sale of shares related to the
Arrangement of $450 thousand which resulted in a net loss and other
comprehensive loss of $7.0 million ($0.03 per share). During the nine
month period ended February 28, 2009, the Company realized a gain related to the
Arrangement in the amount of $6.3 million resulting in net loss and other
comprehensive loss for the period of $2.7 million ($0.01 per
share).
The
decrease in loss from operations for the three months ended February 28, 2009
compared with the same period last year is due primarily to reduced research and
development spending of $1.2 million, resulting from the completion of toxicity
studies ongoing in Q3 2008 and lower drug manufacturing costs as well
as lower
stock based compensation costs of $106 thousand due to one time option grants in
the third quarter of 2008 whereas there were no grants in the third quarter of
2009.
The
decrease in net loss from operations for the nine months ended February 28, 2009
compared with the same period last year is due primarily to lower research and
development costs of $1.3 million resulting from less spending on GLP-toxicity
studies as well as drug manufacturing costs, lower general and administrative
costs of $119 thousand due to reduced legal costs as well as lower stock based
compensation costs of $182 thousand due to one time option grants in the third
quarter of 2008 whereas there were no grants in the third quarter of 2009 and
option modification costs incurred in the second quarter of 2008 offset by lower
interest income of $217 thousand due to lower cash and investment balances and
lower prime rates of interest.
Gain
on sale of shares
As
a result of the Arrangement described below, the Company recognized a gain on
the sale of the shares of Old Lorus to the Investor of approximately $6.3
million for the nine-month period ended February 29, 2008. For the
nine month period ended February 28, 2009 the Company recognized a gain on sale
of $450 thousand which represents the $600 thousand released from escrow less
the $150 thousand liability associated with the indemnification described
below. During the three months ended February 28, 2009 no amounts
were recognized on the gain on sale of the shares. In the same period
last year $11 thousand in expenses were recorded as a loss on sale of the shares
reflecting an adjustment to the transaction costs.
Under
the Arrangement, New Lorus and its subsidiaries have agreed to indemnify Old
Lorus and its directors, officers and employees from and against all damages,
losses, expenses (including fines and penalties), other third party costs and
legal expenses, to which any of them may be subject arising out of any matter
occurring (i) prior to, at or after the effective time of the Arrangement
(“Effective Time”) and directly or indirectly relating to any of the assets of
Old Lorus transferred to New Lorus pursuant to the Arrangement (including losses
for income, sales, excise and other taxes arising in connection with the
transfer of any such asset) or conduct of the business prior to the Effective
Time; (ii) prior to, at or after the Effective Time as a result of any and all
interests, rights, liabilities and other matters relating to the assets
transferred by Old Lorus to New Lorus pursuant to the Arrangement; and (iii)
prior to or at the Effective Time and directly or indirectly relating to, with
certain exceptions, any of the activities of Old Lorus or the
Arrangement.
In
reference to those indemnifications, $600 thousand of the proceeds on the
transaction were held in escrow until the first anniversary of the transaction
and were released to Lorus in July 2008. Lorus has recorded a
liability of $150 thousand, which it believes is a reasonable estimate of the
fair value of the obligation for the indemnifications provided. There
have been no claims under this indemnification to date. This amount
is included on the balance sheet under Accrued Liabilities as at February 28,
2009.
PLAN
OF ARRANGEMENT AND CORPORATION REORGANIZATION
On
July 10, 2007 (the “Arrangement Date”), Lorus Therapeutics Inc. (the “Company”,
“Lorus” or “New Lorus”) completed a plan of arrangement and corporate
reorganization with, among others, 4325231 Canada Inc., formerly Lorus
Therapeutics Inc. (“Old Lorus”), 6707157 Canada Inc. and Pinnacle International
Lands, Inc (the “Arrangement”). As a result of the plan of
arrangement and reorganization, among other things, each common share of Old
Lorus was exchanged for one common share of the Company and the assets
(excluding certain future tax attributes and related valuation allowance) and
liabilities of Old Lorus (including all of the shares of its subsidiaries held
by it) were transferred, directly or indirectly, to the Company and/or its
subsidiaries. The Company continued the business of Old Lorus after
the Arrangement Date with the same officers and employees and continued to be
governed by the same directors as Old Lorus prior to the Arrangement
Date. Therefore, the Company’s operations have been accounted for on
a continuity of interest basis and accordingly, the consolidated financial
statement information below reflect that of the Company as if it had always
carried on the business formerly carried on by Old Lorus. All
comparative figures presented in these consolidated financial statements are
those of Old Lorus prior to the Arrangement Date and the Company after the
Arrangement Date. References in this Management’s Discussion and
Analysis (“MD&A”) to the Company, Lorus, “we”, “our”, “us” and similar
expressions, unless otherwise stated, are references to Old Lorus prior to the
Arrangement Date and the Company after the Arrangement
Date.
REGULATORY
MATTER
On
October 31, 2008 Lorus voluntarily delisted its common shares from trading on
the NYSE Alternext US LLC (formerly the American Stock Exchange or
AMEX). Lorus is eligible to apply for deregistration from the
Securities Exchange Commission one year after delisting from
AMEX. Lorus intends to submit this application by October 31,
2009.
QUARTERLY
FINANCIAL INFORMATION (UNAUDITED)
The
selected financial information provided below is derived from the Company’s
unaudited quarterly financial statements for each of the last eight
quarters.
Research
and development expenditures increased over the four quarters ended August 31,
2008 in comparison with the comparative quarters in the prior
year. This is due to increased activity related to the LOR-2040 and
LOR-253 programs for which development has accelerated. In particular
research and development costs were significantly higher during the quarter
ended February 29, 2008 due to the manufacturing costs associated with producing
additional quantities of LOR-2040 to support the ongoing Phase II clinical trial
in AML. Q4 of 2007 and Q1 of 2008 had particularly low research and
development expenditures as the Company was in between wrapping up the
Virulizin® Phase
III clinical trial and escalating development within the LOR-2040 and LOR-253
programs. Research and development expenditures decreased during the
quarter ended November 30, 2008 compared with the prior period due to reduced
spending on the small molecule toxicity studies which are now
completed. Research and development expenditures were low during the
quarter ended November 30, 2008 due primarily to the timing of activities.
General
and administrative expenses have remained relatively consistent across last
eight quarters with the exception of the following
quarters:
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three
months ended November 30, 2007 reflecting corporate governance costs and
increased corporate communication costs over the previous periods,
and
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the
quarter ended May 31, 2008 resulting from increased legal, professional
and internal control compliance
fees.
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The
Company recognized a gain on sale of shares of $6.1 million on the close of the
Arrangement as discussed above in the quarter ended August 31,
2007. For the quarter ended August 31, 2008 the Company
recognized a gain on sale of shares of $450 thousand related to the release of
funds from escrow net of the value of the guarantee as discussed
above.
(Amounts
in 000’s except for per common share data)
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Feb
28,
2009
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Nov.
30,
2008
|
Aug.
31,
2008
|
May
31,
2008
|
Feb.
29,
2008
|
Nov.
30,
2007
|
Aug.
31,
2007
|
May
31,
2007
|
Revenue
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$
64
|
$ 39
|
$ 3
|
$ 13
|
$ 3
|
$ 1
|
$ 26
|
$ 40
|
Research
and development
|
1,043
|
694
|
1,178
|
1,836
|
2,222
|
1,247
|
782
|
259
|
General
and administrative
|
822
|
920
|
841
|
1,186
|
863
|
1,103
|
736
|
820
|
Net
loss
|
(2,469)
|
(2,284)
|
(2,212)
|
(3,650)
|
(3,850)
|
(2,825)
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3,991
|
(1,689)
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Basic
and diluted
|
|
|
|
|
|
|
|
|
net
(loss) profit per share
|
$
(0.01)
|
$ (0.01)
|
$ (0.01)
|
$ (0.02)
|
$ (0.02)
|
$ (0.01)
|
$ 0.02
|
$ (0.01)
|
Cash
used in operating activities
|
$
(1,789)
|
$ (2,080)
|
$ (1,800)
|
$
(2,722)
|
$(2,586)
|
(2,537)
|
$(2,348)
|
$ (89)
|
Capital
Risk Management
The
Company’s objectives when managing capital are
to:
|
•
|
Maintain
its ability to continue as a going concern in order to provide returns to
shareholders and benefits to other
stakeholders;
|
|
•
|
Maintain
a flexible capital structure which optimizes the cost of capital at
acceptable risk;
|
|
•
|
Ensure
sufficient cash resources to fund its research and development activity,
to pursue partnership and collaboration opportunities and to maintain
ongoing operations.
|
The
capital structure of the Company consists of secured convertible debentures and
equity comprised of share capital, warrants, the equity portion of our secured
convertible debentures, stock options, contributed surplus and deficit. The
Company manages its capital structure and makes adjustments to it in light of
economic conditions. The Company, upon approval from its Board of Directors,
will balance its overall capital structure through new share issuances,
acquiring
or disposing of assets, adjusting the amount of cash and short-term investments
balances or
by undertaking other activities as deemed appropriate under the specific
circumstances. The
Company expects that its current capital resources will be sufficient to carry
its research and development plans and operations for the next twelve months,
but will not be sufficient to repay its convertible debentures on the maturity
date of October 6, 2009 if the debenture holders do not convert their debt into
common shares.
The
Company is not subject to externally imposed capital requirements and the
Company’s overall strategy with respect to capital risk management remains
unchanged from the year ended May 31, 2008.
On
June 25, 2008, the Company filed a short-form prospectus for a rights offering
to its shareholders.
Under
the rights offering, holders of the Company's common shares as of July 9, 2008
(the "Record Date") received one right for each common share held as of the
Record Date. Each four rights entitled the holder thereof to purchase
a unit of Lorus ("Unit"). Each Unit consists of one common share of
Lorus at $0.13 and a one-half common share purchase warrant to purchase
additional common shares of Lorus at $0.18 per common share until August 7,
2010. All unexercised rights expired on August 7,
2008.
Pursuant
to the rights offering the Company issued 28,538,889 common shares and
14,269,444 common share purchase warrants in exchange for cash consideration of
$3.71 million. The total costs associated with the transaction were
$500 thousand. The Company has allocated the net proceeds of $3.2
million received from the issuance of the units to the common shares and the
common share purchase warrants based on their relative fair
values. The fair value of the common share purchase warrants has been
determined based on an option pricing model. The allocation based on
relative fair values resulted in the allocation of approximately $2.8 million to
the common shares and approximately $417 thousand to the common share purchase
warrants.
At
February 28, 2009, Lorus had cash and cash equivalents and short-term
investments totaling $7.3 million compared to $9.4 million at May 31,
2008. The Company invests in highly rated and liquid debt
instruments. Investment decisions are made in accordance with an
established investment policy administered by senior management and overseen by
the board of directors. Working capital (representing primarily cash,
cash equivalents, short term investments and other current assets less current
liabilities) at February 28, 2009 was a deficiency of $7.6 million as compared
to a surplus of $8.0 million at May 31, 2008. The negative working
capital balance as at February 28, 2009 is the result of classifying the
carrying amount of the convertible debentures which are due on October 6, 2009
as a current liability.
We
do not expect to generate positive cash flow from operations in the next several
years due to additional research and development costs, including costs related
to drug discovery, preclinical testing, clinical trials, manufacturing costs and
operating expenses associated with supporting these activities. Negative cash
flow will continue until such time, if ever, that we receive regulatory approval
to commercialize any of our products under development and revenue from any such
products exceeds expenses.
We
will need to seek to access the public or private equity markets in order to
fund our ongoing research and development activities as well as to repay the $15
million convertible debentures due October 6, 2009 should the holder chose not
to convert. We intend to use our resources to fund our existing drug development
programs and develop new programs from our portfolio of preclinical research
technologies. The amounts actually expended for research and drug development
activities and the timing of such expenditures will depend on many factors,
including the ability of the Company to raise additional capital, the progress
of the Company's research and drug development programs, the results of
preclinical and clinical trials, the timing of regulatory submissions and
approvals, the impact of any internally developed, licensed or acquired
technologies, our ability to find suitable partnership agreements to assist
financially with future development, the impact from technological advances,
determinations as to the commercial potential of the Company's compounds and the
timing and development status of competitive
products.
Contractual
Obligations and Off-Balance Sheet Financing
At
February 28, 2009, we had contractual obligations requiring annual payments as
follows:
(Amounts
in 000’s)
|
Less
than 1 year
|
1-3
years
|
Total
|
Operating
leases
|
147
|
176
|
323
|
Convertible
Debenture1
|
15,000
|
-
|
15,000
|
Total
|
15,147
|
176
|
15,323
|
1
The
convertible debentures as described above may be converted into common shares of
Lorus at a conversion price of $1.00 per share. In the event that the
holder does not convert the debentures, Lorus has an obligation to repay the
$15.0 million in cash. The amounts above excludes interest expense
which is payable monthly by issuance of common shares which is calculated at a
rate of prime plus 1% on the outstanding balance. The convertible
debentures are due on October 6, 2009.
In
addition, the Company is party to certain licensing agreements that require the
Company to pay a proportion of any fees that the Company may receive from future
revenues or milestone payments. As of February 28, 2009 no amounts have been
received by the Company relating to these licensing agreements and therefore, no
amounts are owing and the amount of future fees is not
determinable.
The
Company has entered into various consulting agreements that upon execution of a
partnership agreement could result in liabilities owing to such
consultants. The amounts payable in these agreements are contingent
on the amounts receivable by Lorus under such partnership
agreements. As of February 28, 2009 no amounts are owing and the
amount of future fees payable to the consultants is not
determinable.
As
at February
28, 2009,
we have not entered into any off- balance sheet
arrangements.
Under
the Arrangement, Lorus agreed to indemnify Old Lorus and its directors, officers
and employees from and against all damages, losses, expenses (including fines
and penalties), other third party costs and legal expenses, to which any of them
may be subject arising out of any matter occurring:
|
(i)
|
prior
to, at or after the effective time of the Arrangement ("Effective Time")
and directly or indirectly relating to any of the assets of Old Lorus
transferred to New Lorus pursuant to the Arrangement (including losses for
income, sales, excise and other taxes arising in connection with the
transfer of any such asset) or conduct of the business prior to the
Effective Time;
|
|
(ii)
|
prior
to, at or after the Effective Time as a result of any and all interests,
rights, liabilities and other matters relating to the assets transferred
by Old Lorus to New Lorus pursuant to the Arrangement;
and
|
|
(iii)
|
prior
to or at the Effective Time and directly or indirectly relating to, with
certain exceptions, any of the activities of Old Lorus or the
Arrangement.
|
Lorus
has recorded a liability of $150 thousand, which we believe is a reasonable
estimate of the fair value of the obligation for the indemnifications
provided. There have been no claims under this indemnification to
date. This amount is included on the balance sheet under Accrued
Liabilities.
The
Company has classified its financial instruments as
follows:
|
|
February
28,
|
|
|
May
31,
|
|
|
|
2009
|
|
|
2008 |
|
Financial
assets
|
|
|
|
|
|
|
Cash
and cash equivalents, consisting of term
deposits,
|
|
|
|
|
|
|
and
guaranteed investment certificates, held for
trading,
|
|
|
|
|
|
|
measured
at fair value
|
|
$ |
5,644 |
|
|
$ |
2,652 |
|
|
|
|
|
|
|
|
|
|
Short-term
investments, held-to-maturity,
|
|
|
|
|
|
|
|
|
recorded
at amortized cost
|
|
|
1,142 |
|
|
|
6,304 |
|
|
|
|
|
|
|
|
|
|
Short-term
investments, held-for-trading,
|
|
|
|
|
|
|
|
|
recorded
at fair value
|
|
|
486 |
|
|
|
480 |
|
|
|
|
|
|
|
|
|
|
Amount
held in escrow, measured at amortized
cost
|
|
|
— |
|
|
|
600 |
|
|
|
|
|
|
|
|
|
|
Financial
liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable, measured at amortized
cost
|
|
|
312 |
|
|
|
923 |
|
|
|
|
|
|
|
|
|
|
Accrued
liabilities, measured at amortized
cost
|
|
|
1,300 |
|
|
|
1,194 |
|
|
|
|
|
|
|
|
|
|
Secured
convertible debentures,
|
|
|
|
|
|
|
|
|
measured
at amortized cost
|
|
|
13,915 |
|
|
|
12,742 |
|
Financial
risk management
The
Company has exposure to credit risk, liquidity risk and market risk. The
Company’s Board of Directors has the overall responsibility for the oversight of
these risks and reviews the Company’s policies on an ongoing basis to ensure
that these risks are appropriately managed.
Credit
risk
Credit
risk is the risk of financial loss to the Company if a customer, partner or
counterparty to a financial instrument fails to meet its contractual
obligations, and arises principally from the Company’s cash and cash equivalents
and short-term investments. The carrying amount of the financial assets
represents the maximum credit exposure.
The
Company manages credit risk for its cash and cash equivalents and short-term
investments by maintaining minimum standards of R1 low or A low investments and
Lorus invests only in highly rated Canada and U.S. corporations with debt
securities that are traded on active markets and are capable of prompt
liquidation.
Liquidity
risk
Liquidity
risk is the risk that the Company will not be able to meet its financial
obligations as they come due. To the extent that the Company does not believe it
has sufficient liquidity to meet its current obligations, the Board considers
securing additional funds through equity, debt or partnering transactions. The
Company manages its liquidity risk by continuously monitoring forecasts and
actual cash flows. Refer to note 1 of the financial statements for
further discussion on the Company’s ability to continue as a going concern and
the liquidity risk associated with the secured convertible debentures due
October 6, 2009.
Market
risk
Market
risk is the risk that changes in market prices, such as interest rates, foreign
exchange rates, and equity prices will affect the Company’s income or the value
of its financial instruments.
The
Company is subject to interest rate risk on its cash and cash equivalents,
short-term investments and secured convertible debentures. The
Company does not believe that the results of operations or cash flows would be
affected to any significant degree by a sudden change in market interest rates
relative to interest rates on the investments, owing to the relative short-term
nature of the investments. The secured convertible debentures accrue
interest at a rate of prime + 1%. A change of 100 basis points in the
prime interest rate would have increased (decreased) equity and net income by
approximately $38 thousand ($38 thousand) for the quarter ended February 28,
2009. This analysis assumes all other variables remain
constant.
Financial
instruments potentially exposing the Company to foreign exchange risk consist
principally of accounts payable and accrued liabilities. The Company
holds minimal amounts of U.S. dollar denominated cash, purchasing on an as
needed basis to cover U.S. dollar denominated payments. At February
28, 2009 U.S. dollar denominated accounts payable and accrued liabilities
amounted to $190 thousand. Assuming all other variables remain
constant, a 10% depreciation or appreciation of the Canadian dollar against the
U.S. dollar would result in an increase or decrease in net loss and
comprehensive loss of $19 thousand ($19 thousand). The Company does
not have any forward exchange contracts to hedge this
risk.
The
Company does not invest in equity instruments of other corporations other than a
19% interest held in Zor Pharmaceuticals that is the licensee of
Virulizin. The Company paid a nominal amount for this equity interest
and is not exposed to any losses in excess of this nominal
amount.
Until
one of our drug candidates receives regulatory approval and is successfully
commercialized, Lorus will continue to incur operating losses. The
magnitude of these operating losses will be largely affected by the timing and
scope of future research and development, clinical trials and other development
activities related to the Company’s lead products, as well as any new
initiatives. Finally, the duration of the operating losses will
depend on the scientific results of such clinical trials. As
mentioned above Lorus has a $15 million convertible debenture due on October 6,
2009 for which it does not currently have the cash and cash equivalents to
satisfy this obligation.
TRANSACTIONS
WITH RELATED PARTIES
During
the three months ended February 28, 2009 the Company expensed consulting fees of
$6 thousand (2008 - $nil) to a director of the Company and for the nine months
ended February 28, 2009, Lorus expensed consulting fees of $18 thousand (2008 -
$nil) to the same director. At February 28, 2009 $18 thousand (2008 -
$nil) remained payable and is included in Accrued Liabilities on the balance
sheet.
This
transaction was in the normal course of business and has been measured at the
exchange amount, which is the amount of consideration established and agreed to
by the related parties.
RISK
FACTORS
Before
making an investment decision with respect to our common shares, you should
carefully consider the following risk factors, in addition to the other
information included or incorporated by reference into this report. The risks
set out below are not the only risks we face. If any of the following risks
occur, our business, financial condition, prospects or results of operations
would likely suffer. In that case, the trading price of our common shares could
decline and you may lose all or part of the money you paid to buy our common
shares.
Please
refer to the MD&A included in our 2008 Annual Report for a complete
discussion of risks and uncertainties.
|
•
|
The
cash and cash equivalents on hand are not sufficient to repay the
debentures at maturity. If
we cannot repay or refinance the debentures at or prior to maturity, the
lender may, at its discretion: commence
legal action; take possession of our assets; carry on our business;
appoint a receiver; and take any other action permitted by law to obtain
payment.
|
|
•
|
Our
current capital resources are not sufficient to fund our long-term
business strategy or to repay our convertible debentures. We
need to raise additional capital. We cannot assure you that additional
funding will be available at all or on terms which are acceptable to us or
in amounts that will enable us to carry out our business
plan.
|
|
•
|
We
have a history of operating losses. We expect to incur net losses and we
may never achieve or maintain
profitability.
|
|
•
|
We
may be unable to obtain partnerships for one or more of our product
candidates which could curtail future development and negatively impact
our share price.
|
|
•
|
Clinical
trials are long, expensive and uncertain processes and Health Canada or
the FDA may ultimately not approve any of our product candidates. We may
never develop any commercial drugs or other products that generate
revenues.
|
|
•
|
We
may violate one or more of the operational covenants related to our
convertible debentures that could result in an event of default and the
requirement for early payment of our convertible
debentures.
|
|
•
|
As
a result of intense competition and technological change in the
pharmaceutical industry, the marketplace may not accept our products or
product candidates, and we may not be able to compete successfully against
other companies in our industry and achieve
profitability.
|
|
•
|
We
may be unable to obtain patents to protect our technologies from other
companies with competitive products, and patents of other companies could
prevent us from manufacturing, developing or marketing our
products.
|
|
•
|
Our
products and product candidates may infringe the intellectual property
rights of others, which could increase our
costs.
|
|
•
|
Our
share price has been and may continue to be volatile and an investment in
our common shares could suffer a decline in
value.
|
|
•
|
Future
sales of our common shares by us or by our existing shareholders could
cause our share price to
fall.
|
|
•
|
Conversion
of our secured convertible debentures will dilute the ownership interest
of existing
shareholders.
|
CRITICAL
ACCOUNTING POLICIES
Critical
Accounting Policies and Estimates
Our accounting policies are in
accordance with Canadian GAAP including some that require management to make
assumptions and estimates that could significantly affect the results of
operations and financial position. The significant accounting
policies that we believe are the most critical in fully understanding and
evaluating the reported financial results are disclosed in the MD&A section
of our 2008 annual report. As well, our significant accounting
policies are disclosed in Note 3, Significant
Accounting Policies, of
the notes to the financial statements of Lorus provided in our annual report for
the fiscal year ended May 31, 2008.
Recently
Adopted Accounting Recommendations
Effective June 1, 2008, the Company
adopted the following accounting policies:
Accounting
changes:
Effective
June 1, 2008, the Company adopted the Accounting Standards Board’s (“AcSB”)
replacement of Section 1506, Accounting Changes. The new standard allows for
voluntary changes in accounting policy only when they result in the financial
statements providing reliable and more relevant information; requires changes in
accounting policy to be applied retrospectively unless doing so is
impracticable; requires prior period errors to be corrected retrospectively; and
calls for enhanced disclosures about the effects of changes in accounting
policies, estimates and errors on the financial statements. The adoption of this
standard did not have any impact on the Company’s financial statements during
the three and nine month periods ended February 28,
2009.
Capital
disclosures:
Effective
June 1, 2008, the Company adopted the new recommendations of the Canadian
Institute of Chartered Accountants (“CICA”) Handbook Section 1535, Capital
Disclosures (“Section 1535”). Section 1535 establishes standards for disclosing
information about an entity’s capital and how it is managed. It requires the
disclosure of information about: (i) an entity’s objectives, policies and
processes for managing capital; complied with any capital requirements; and if
it has not complied, the consequences of such non-compliance. The Company has
included disclosures recommended by Section 1535 in note 3 of the financial
statements.
Financial
instruments:
Effective
June 1, 2008, the Company adopted the new recommendations of CICA Handbook
Section 3862, Financial Instruments - Disclosures (“Section 3862”) and Handbook
Section 3863, Financial Instruments - Presentation (“Section 3863”). Section
3862 requires entities to provide disclosures in their financial statements that
enable users to evaluate the significance of financial instruments on the
entity’s financial position and its performance and the nature and extent of
risks arising from financial instruments to which the entity is exposed during
the period and at the balance sheet date, and how the entity manages those
risks. Section 3863 establishes standards for presentation of financial
instruments and nonfinancial derivatives. It deals with the classification of
financial instruments, from the perspective of the issuer, between liabilities
and equities, the classification of related interest, dividends, losses and
gains, and circumstances in which financial assets and financial liabilities are
offset. The adoption of these standards did not have any impact on the
classification and valuation of the Company’s financial instruments. The Company
has included disclosures recommended by these new Handbook Sections in note 4 of
the financial statements
General
standards of financial statement presentation:
In
May 2007, the AcSB amended CICA Handbook Section 1400 “General Standards of
Financial Statement Presentation”, to change the guidance related to
management’s responsibility to assess the ability of the entity to continue as a
going concern.
The
main features of the changes are as follows:
|
(i)
|
management
is required to make an assessment of an entity’s ability to continue as a
going concern;
|
|
(ii)
|
in
making its assessment, management takes into account all available
information about the future, which is at least, but is not limited to,
twelve months from the balance sheet
date;
|
|
(iii) |
financial
statements must be prepared on a going concern basis unless management
either intends to liquidate the entity, to cease trading or cease
operations, or has no realistic alternative but to do
so;
|
|
(iv) |
disclosure
is required of material uncertainties related to events or conditions that
may cast significant doubt upon the entity’s ability to continue as a
going concern; and
|
|
(v) |
when
financial statements are not prepared on a going concern basis, that fact
should be disclosed, together with the basis on which the financial
statements are prepared and the reason the entity is not regarded as a
going
concern.
|
The
effective date of these amendments is for interim and annual financial
statements relating to fiscal years beginning on or after January 1, 2008,
specifically June 1, 2008 for the Company. The new disclosure requirements
pertaining to this Section are contained in note 1 of the financial
statements.
Recent
Accounting Recommendations not yet adopted
The CICA plans to converge Canadian
GAAP with International Financial Reporting Standards (IFRS) over a transition
period expected to end in 2011. The
impact of the transition to IFRS on the Company’s financial statements has not
been determined.
Section
3064, “Goodwill and intangible assets”, will be replacing Section 3062,
“Goodwill and other intangible assets” and
Section 3450, “Research and development costs”. This new section, issued in
February 2008, will be applicable to financial statements relating to fiscal
years beginning on or after October 1, 2008. Accordingly, the Company will adopt
the new standards for its fiscal year beginning June 1, 2009. It establishes
standards for the recognition, measurement, presentation and disclosure of
goodwill subsequent to its initial recognition and of intangible assets by
profit-oriented enterprises. Standards concerning goodwill are unchanged from
the standards included in the previous Section 3062. The
impact of adoption of this new section on the Company’s financial statements has
not been determined.
DISCLOSURE
CONTROLS AND INTERNAL CONTROLS OVER FINANCIAL
REPORTING
The
Company has implemented a system of internal controls that it believes
adequately protects the assets of the Company and is appropriate for the nature
of its business and the size of its operations. These
internal controls include disclosure controls and procedures designed to ensure
that information required to be disclosed by the Company is accumulated and
communicated as appropriate to allow timely decisions regarding required
disclosure.
As
at February 28, 2009, the Company’s management evaluated the effectiveness of
the design and operation of its disclosure controls. Based on their evaluation,
the Chief Executive Officer and the Chief Financial Officer have concluded that
the disclosure controls and procedures are effective.
In
the course of evaluating its internal controls over financial reporting as at
May 31, 2008, management identified the following reportable
deficiencies:
Segregation
of Duties
Given
our limited staff, certain duties within the accounting and finance department
cannot be properly segregated. We believe that none of the segregation of duty
deficiencies has resulted in a misstatement to the financial statements as we
rely on certain compensating controls, including substantive periodic review of
the financial statements by the Chief Executive Officer and Audit Committee.
This weakness is considered to be a common area of deficiency for many smaller
listed companies in Canada. We continue to evaluate whether additional
accounting staff should be hired to deal with this
weakness.
Complex
and Non-Routine Transactions
As
required, we record complex and non-routine transactions. These sometimes are
extremely technical in nature and require an in-depth understanding of GAAP. Our
accounting staff has only a fair and reasonable knowledge of the rules related
to GAAP and reporting and the transactions may not be recorded correctly,
potentially resulting in material misstatement of our financial
statements.
To
address this risk, we consult with our third party expert advisors as needed in
connection with the recording and reporting of complex and non-routine
transactions. In addition, an annual audit is completed by our auditors, and
presented to the Audit Committee for its review and approval. During the audit
for the fiscal year ended May 31, 2008, no material misstatements were
identified. At a future date, we may consider expanding the technical expertise
within our accounting function. In the meantime, we will continue to work
closely with our third party advisors.
There
have been no significant changes to the Company’s internal control environment
during the three months ended February 28, 2009 that would have materially
affected the Company’s internal controls over financial
reporting.
UPDATED
SHARE INFORMATION
As
at April 13, 2009, the Company had 255,617,000 common shares issued and
outstanding and 14,269,444 common share purchase warrants convertible into an
equal number of common shares. In addition, the Company had issued and
outstanding 16,990,000 stock options to purchase an equal number of common
shares, and a $15 million convertible debenture convertible into common shares
of Lorus at $1.00 per share.
ADDITIONAL
INFORMATION
Additional
information relating to Lorus, including Lorus' 2008 annual information form and
other disclosure documents, is available on SEDAR at www.sedar.com. For
any information filed prior to July 10, 2007 please access the information on
SEDAR for Global Summit Real Estate Inc. (Old
Lorus).
11