Management's
Discussion and Analysis
August
28, 2008
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 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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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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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 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 repay or
refinance the convertible debentures at
maturity;
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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.
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. 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.
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",
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, 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 net
loss for 2008 decreased to $6.3 million ($0.03 per share) compared to a net loss
of $9.6 million ($0.5 per share) in 2007. Operating net loss, before
the gain on sale of shares associated with the completion of the Arrangement,
increased to $12.6 million or $0.06 per share in 2008 as compared to $9.6
million or $0.05 per share in 2007. Research and development
expenses in 2008 increased to $6.1 million from $3.4 million in
2007. The increase in research and development expenditures is the
result of an increase in activity in both our LOR-2040 and LOR-253 (small
molecule) development programs. We utilized cash of $10.2
million in our operating activities in 2008 compared with $6.3 million in 2007;
the higher utilization is consistent with higher research and development
activities. At the end of 2008 we had cash and cash equivalents, short-term
investments and marketable securities of $9.4 million compared to $12.4 million
at the end of 2007. Subsequent to year-end the rights offering
provided the company with gross proceeds of approximately $3.71
million.
Revenues
for the year decreased to $43 thousand compared with 2007 revenue of $107
thousand and $26 thousand in 2006. The decrease in revenue in 2008 is
due to a decrease in services performed by Lorus personnel on behalf of other
companies. Lorus recognized $10 thousand in revenue associated with
the $100 thousand received as a non-refundable up front milestone payment
associated with the license of Virulizin®. This
license agreement provides for payments in excess of US$10 million upon the
achievement of various milestone events and royalties that vary from 10-20%
depending on the level of sales of Virulizin® achieved in those
territories covered by the license and subject to certain other
adjustments. We do not expect that any of these milestones will be
achieved in the next 12 months. The license transaction is considered
a multiple deliverable arrangement and as such Lorus is recognizing the
milestone payment as agreed upon consulting services are
performed. The balance of revenue earned in 2008 is related to
laboratory services performed by Lorus personnel on behalf of other
companies. The increase in revenue in 2007 compared with 2006 is
related to increased laboratory services work performed by Lorus personnel on
behalf of other companies. The Company did not receive any revenue
under its licensing agreement with Cyclacel Ltd. in connection with the out
licensing of our clotrimazole analog library of anticancer drug candidates. The
agreement included an initial license fee of $546 thousand received in 2004 with
the potential of additional license fees of up to U.S.$11.6 million that may be
earned if Cyclacel achieves certain defined research and development milestones.
We do not expect that any of these milestones will be achieved in the next 12
months.
Research
and development expenses totaled $6.1 million in 2008 compared to $3.4 million
in 2007 and $10.2 million in 2006. The increase in research and
development expenditures in 2008 is due to a significant increase in activity
within our LOR-2040 and small molecule development programs. In
particular the initiation of an advanced Phase II clinical trial with LOR-2040
in acute myeloid leukemia and the manufacturing costs of the drug needed to
complete the trial, the advancement of our small molecule program into
GLP-toxicology studies and GLP-toxicology studies with LOR-2040 for the
treatment of bladder cancer. This increase in spending is offset by
lower amortization of acquired patents and license of $655 thousand which was
fully amortized in 2007. The decrease in spending in 2007
compared with 2006 was the result of the close of the Virulizin® Phase III clinical
trial for the treatment of advanced pancreatic cancer in 2006 as well as a
reduction in headcount in November 2005 and a reduction in amortization of
acquired patents and licenses of $1.6 million which was fully amortized part way
through 2007.
General
and Administrative
General
and administrative expenses totaled $3.9 million in 2008 compared to $3.8
million in 2007 and $4.3 million in 2006. General and administrative expenses
remained consistent year over year as we continue to work to minimize our
non-research and development costs. The decrease in general and
administrative costs in 2007 over 2006 is the result of staff reductions, and a
continued focus on lowering costs in all areas of the business. The cost savings
realized during 2007 were partially offset by charges incurred under the mutual
separation agreement entered into with Dr. Wright discussed under “Corporate
Changes” below.
Stock-Based
Compensation
Stock-
based compensation expense totaled $719 thousand in 2008 compared with $503
thousand in 2007 and $1.2 million in 2006. The increase in stock
based compensation in 2008 compared with 2007 is the result of an of an increase
in options granted during 2008 in order to bring option granting practices in
line with industry standards as well as an expense of $83 thousand related to a
modification as described below. The decrease in stock-based
compensation expense in 2007 compared with 2006 was the result of reduced fair
values on the stock options issued, due to a decline in our stock price, as well
as a significant number of unvested options that were forfeited during 2007
reducing the overall expense.
During
2008, a modification of the expiry date of options previously granted to
directors not standing for re-election at the Company’s annual general meeting
and to Dr. Wright for options granted in his capacity as President and CEO was
approved by the Company’s Board of Directors. An expense of $83
thousand was recorded during the year due to these expiry date
modifications.
During
2006, employees of the Company (excluding directors and officers) were given the
opportunity to choose between keeping 100% of the options they held at the
existing exercise prices or forfeiting 50% of the options held in exchange for
having the remaining 50% of the exercise prices of the options re-priced to
$0.30 per share. Employees holding 2,290,000 stock options opted for
re-pricing their options, resulting in the amendment of the exercise price of
1,145,000 stock options and the forfeiture of 1,145,000 stock options during the
quarter ended February 28, 2006.
Depreciation
and Amortization
Depreciation
and amortization expenses decreased to $317 thousand in 2008 as compared to $402
thousand in 2007 and $771 thousand in 2006. The decrease in
depreciation and amortization expense is the result of reduced capital asset
purchases during fiscal 2008 and 2007. In 2006, the Company took a write-down of
$250 thousand on certain furniture and equipment whose carrying value was deemed
to be unrecoverable and in excess of the fair value of the underlying
assets.
Interest
Expense
Non-cash
interest expense was $1.0 million in 2008 compared with $1.0 million in 2007 and
$882 thousand in 2006. These amounts represent interest at a rate of
prime plus 1% on the $15 million convertible debentures. The interest
expense in 2008 was consistent with 2007 as the average annual interest rate
remained comparable between the two years. The increase in interest
expense in 2007 compared with 2006 is a function of higher interest rates due to
increases in the prime rate in late 2006.
Accretion
in Carrying Value of Secured Convertible Debentures
Accretion
in the carrying value of the debentures amounted to $1.2 million in 2008
compared with $935 thousand in 2007 and $790 thousand in
2006. Amortization of deferred financing charges totaled nil in 2008
compared with $110 thousand in 2007 and $87 thousand in 2006. The
increase in accretion charges in 2008 is due to the reclassification of
amortization of deferred financing charges to accretion expense due to the
adoption of Section 3855, Financial Instruments as described under Accounting
Policy Changes below. These 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 in 2007 compared
with 2006 is due to a higher effective rate of interest.
Interest
and Other Income
Interest
income totaled $542 thousand in 2008 compared to $503 thousand in 2007 and $374
thousand in 2006. The slight increase in 2008 over 2007 is the result of a
marginally higher average cash balance in 2008 compared with 2007 and the
opportunity to earn better rates of return. The increase from 2006 to
2007 is due to higher average cash and marketable securities balances in 2007
and by higher interest rates during 2007. Higher average cash and
marketable securities balances in 2007 were primarily a function of the funds
received as part to of the August 2006 private placements described under
“Financing” below.
Loss
for the Year
Operating
net loss for the year, before the gain on sale of shares associated with the
completion of the Arrangement, increased to $12.6 million or $0.06 per share in
2008 as compared to $9.6 million or $0.05 per share in 2007 and $17.9 million or
$0.10 per share in 2006. The increase in operating net loss during
2008 compared with 2007 is primarily the result of increased research and
development costs of $2.7 million associated with the ongoing LOR-2040 phase II
clinical trial in AML, the advancement of our small molecule program and
LOR-2040 for the treatment of bladder cancer into GLP-toxicology
studies. The decrease in net loss in 2007 compared with 2006 is
due to lower research and development costs resulting from the close of our
Virulizin® Phase III clinical
trial as well as staff reductions due to corporate changes, lower general and
administrative costs due to staff reductions and lower legal, consulting and
investor relations charges, depreciation and amortization and higher interest
income and offset by higher accretion costs.
Gain
on sale of shares
As a
result of the Arrangement, we recognized a gain on the sale of the shares of Old
Lorus to the Investor of approximately $6.3 million. Under the
Arrangement, a number of steps were undertaken. However, these steps
did not result in any taxes payable as the tax benefit of income tax attributes
was applied to eliminate any taxes otherwise payable. Of the total
unrecognized future tax assets available at the time of the Arrangement,
approximately $7.0 million was transferred to New Lorus and the balance remained
with Old Lorus and is subject to the indemnification agreement as described
below. Those tax attributes remaining with Old Lorus are no longer
available to the Company.
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.
With
respect to the forgoing indemnity, $600 thousand of the proceeds on the
transaction were held in escrow until the first anniversary of the transaction
(July 2008). Subsequent to year end the $600 thousand was released
from escrow. At May 31, 2008 Lorus has deferred the entire amount of
the proceeds held in escrow as its estimate of any liability arising from the
indemnity.
License
Transaction
Effective
April 8, 2008, we entered into a non-exclusive multinational license agreement
with ZOR Pharmaceutical LLC ("ZOR") formed as a subsidiary of Zoticon
Bioventures Inc. to further develop and commercialize Virulizin® for human therapeutic
applications.
Under
the terms of the agreement, we will received an upfront licensing fee of $100
thousand, and may receive up to approximately U.S. $10 million in milestone
payments based on progress through financing and clinical development, and
royalties on net sales that vary from 10-20% depending on the level of sales of
Virulizin® achieved in
those territories covered by the license and subject to certain other
adjustments. ZOR will assume all future costs for the development of the
licensed technology.
We have
also entered into a service agreement with ZOR to assist in the transfer of
knowledge. Under this agreement, we have agreed to provide ZOR with 300 hours of
consulting service during a period of 18 months.
In
addition, we acquired a 25% equity interest in ZOR in exchange for a capital
contribution of $2,500. This investment has been accounted for as an equity
investment. Lorus' equity will not be subject to dilution on the first U.S. $5
million of equity financing in ZOR. Thereafter, Lorus has, at its option, a
right to participate in any additional financings to maintain its ownership
level.
CORPORATE
CHANGES
As
discussed above, on July 10, 2007, the Company and Old Lorus completed a plan of
arrangement and corporate reorganization with, among others, 6707157 Canada Inc.
and Pinnacle International Lands, Inc. As part of the Arrangement,
all of the assets and liabilities of Old Lorus (including all of the shares of
its subsidiaries held by it), with the exception of certain future tax assets
were transferred, directly or indirectly, from Old Lorus to the
Company. Securityholders in Old Lorus exchanged their securities in
Old Lorus for equivalent securities in New Lorus and the board of directors and
management of Old Lorus continued as the board of directors and management of
New Lorus. New Lorus obtained substitutional listings of its common
shares on both the Toronto Stock Exchange and the American Stock
Exchange.
As part
of the Arrangement, the Company changed its name to Lorus Therapeutics Inc. and
continued as a biopharmaceutical company, specializing in the research and
development of pharmaceutical products and technologies for the management of
cancer as a continuation of the business of Old Lorus. In October
2007, Old Lorus changed its name from 4325231 Canada Inc. to Global Summit Real
Estate Inc.
Dr.
Wright resigned as the President and Chief Executive Officer effective September
21, 2006. The Company accrued a liability based on a mutual
separation agreement executed during the year. As a result, we
recorded severance compensation expense of $500 thousand recorded in general and
administrative expense in the year ended May 31, 2007. All
amounts payable under the mutual separation agreement were paid during fiscal
2007.
In
November 2005, as a means to conserve cash and refocus operations, Lorus scaled
back some activities related to the Virulizin® technology and
implemented a workforce reduction of approximately 39% or 22
employees. As a result, for the year ended May 31, 2006, the Company
recorded severance compensation expense for former employees of $557
thousand. Of this expense, $468 thousand is presented in the income
statement as general and administrative expense and $89 thousand as research and
development expense. Accounts payable and accrued liabilities at May
31, 2006 includes severance and compensation expense liabilities relating to the
Company’s November 2005 corporate changes of $154 thousand that were paid out by
December 2006.
REGULATORY
MATTER
Lorus
received notice from the American Stock Exchange ("AMEX") dated February 13,
2008, indicating that we needed to comply with the $6 million stockholder's
equity threshold required for continued listing under AMEX Company Guide Sec.
1003(a)(iii). This notification was triggered by the decline of Lorus' market
capitalization to less than $50 million, which previously exempted us from
meeting the minimum stockholder's equity requirement. AMEX has renewed and
accepted our plan to comply with the stockholder's equity requirements within an
eighteen month period ending August 13, 2009. Should we not be able to execute
the plan and comply with the AMEX requirements within the prescribed period,
Lorus will be subject to de-listing.
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. The Company is currently in the assessment phase of results
from its LOR-2501 Phase II clinical trial and is not incurring significant costs
thereon. We will continue the development of our small molecule
programs from internal resources until their anticipated
completion.
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 should the holder not choose to convert the debentures into common
shares. 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 may not be
able to continue as a going concern and realize our assets and pay our
liabilities as they fall due. 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 our
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.
Management believes that our current
level of cash and cash equivalents and short term investments will be sufficient
to execute our current planned expenditures for the next twelve months; however,
the $15 million convertible debt obligation is due in October 2009 and we
currently does not have the cash and cash equivalents to satisfy this
obligation. If the
Company is not able to raise additional funds, it may not be able to continue as
a going concern and realize its assets and pay its liabilities as they fall due.
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.
Operating
Cash Requirements
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Lorus
utilized cash in operating activities of $10.2 million in 2008 compared with
$6.3 million in 2007 and $13.1 million in 2006. The increase in cash used in
operating activities in 2008 of $3.9 million compared with 2007 is due to an
increase in research and development expenditures of $2.7 million as well as a
reduction in amortized acquired patents and licenses of $655 thousand which were
fully amortized in 2007 and an increase in cash used in non-cash working capital
of $484 thousand. The decrease in cash used in operating activities in 2007 of
is primarily due to lower research and development and general and
administrative expenses, as described above and higher interest
income.
As at
May 31, 2008, Lorus has cash and cash equivalents and short-term investments
totaling $9.4 million compared to $12.4 million at the end of
2007. 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 and cash equivalents and
short-term investments having maturities of less that one year) at May 31, 2008
was $8.0 million as compared to $6.2 million at May 31, 2007. As
discussed below, subsequent to year-end, Lorus initiated a rights offering that
raised gross proceeds of approximately $3.71 million in additional cash for
Lorus. In addition the $600 thousand held in escrow at May 31, 2008
was released to Lorus on July 10, 2008.
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 may
seek to access the public or private equity markets from time to time, even if
we do not have an immediate need for additional capital at that time. 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 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.
Subsequent
to the year-end the Company announced a rights offering to Lorus shareholders
that raised gross proceeds of $3.71 million.
On July
10, 2007, Lorus completed a reorganization that had the effect of providing the
Company with non-dilutive financing of $8.5 million in additional cash, before
transaction costs, for New Lorus, subject to a $600 thousand holdback. The amount was released to Lorus on July
10, 2008. See Gain on Sale of Shares, above.
On July 13, 2006
the Company entered into an agreement with HighTech Beteiligungen GmbH & Co.
KG (“HighTech”) to issue 28.8 million common shares at $0.36 per share for gross
proceeds of $10.4 million. The subscription price represented a premium of 7.5%
over the closing price of the common shares on the Toronto Stock Exchange on
July 13, 2007. The transaction closed on August 31, 2006. In
connection with the transaction, HighTech received demand registration rights
that will enable HighTech to request the registration or qualification of the
common shares for resale in the United States and Canada, subject to certain
restrictions. These demand registration rights expire on June 30, 2012. In
addition, HighTech received the right to nominate one nominee to the board of
directors of Lorus or, if it does not have a nominee, it will have the right to
appoint an observer to the board. Upon completion of the transaction, HighTech
held approximately 14% of the issued and outstanding common shares of Lorus
Therapeutics Inc.
On July 24, 2006
Lorus entered into an agreement with Technifund Inc. to issue on a private
placement basis, 5 million common shares at $0.36 per share for gross proceeds
of $1.8 million. The transaction closed on September 1, 2006.
In
2008, Lorus issued no common shares on the exercise of stock options for nil
proceeds (2007, $22 thousand, 2006, nil).
Use
of Proceeds
In our
prospectus dated August 11, 2006 related to the subscription of shares by High
Tech, the Company indicated that proceeds from the financing would be used as
follows: $8.6 million to fund the development of our product candidates, and the
balance for working capital and general corporate purposes. Since the date of
receipt of funds, the company has incurred $4.5 million in research and
development expenses on our immunotherapy and antisense programs and $3.9
million on our small molecule program.
CONTRACTUAL
OBLIGATIONS
At May
31, 2008, we had contractual obligations requiring annual payments as
follows:
(Amounts
in 000’s)
|
|
Less
than
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1
year
|
|
|
1-3
years
|
|
|
4-5
years
|
|
|
5+
years
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
leases
|
|
|
143 |
|
|
|
287 |
|
|
|
- |
|
|
|
- |
|
|
|
430 |
|
Convertible
Debenture1
|
|
|
- |
|
|
|
15,000 |
|
|
|
- |
|
|
|
- |
|
|
|
15,000 |
|
Total
|
|
|
143 |
|
|
|
15,287 |
|
|
|
- |
|
|
|
- |
|
|
|
15,430 |
|
1 The
convertible debentures as described above may be converted into common shares of
Lorus at a conversion price of $1.00. 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 exclude interest expense which is
payable by issuance of common shares which is calculated at a rate of prime plus
1% on the outstanding balance.
OFF-BALANCE
SHEET ARRANGEMENTS
As at
May 31, 2008, we have not entered into any off- balance sheet
arrangements.
TRANSACTIONS
WITH RELATED PARTIES
During
the year ended May 31, 2008, we expensed consulting fees of $31,000 to a
director of Lorus (2007 - nil, 2006 - nil) of which $30,000 remained payable at
May 31, 2008 (2007 - nil, 2006 - nil).
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 by
the related parties.
SUBSEQUENT
EVENTS
On June
25, 2008, Lorus filed a short-form prospectus for a rights offering to our
shareholders.
Under
the rights offering, holders of our 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 (4) 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 warrant to purchase additional common shares of Lorus at $0.18 until
August 7, 2010.
Rights
expired on August 7, 2008. 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. We expect to use the net proceeds from the offering to fund
research and development activities and for general working capital
purposes.
RISK
FACTORS
Investing
in our securities involves a high degree of risk. 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 annual information form, as well
as our historical consolidated financial statements and related notes. 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.
We
need to raise additional capital
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. To obtain the necessary capital, we must rely on any or all
of; grants and tax credits, additional share issues and collaboration agreements
or corporate partnerships to provide full or partial funding for our activities.
We cannot assure you that additional funding will be available on terms which
are acceptable to us or in amounts that will enable us to carry out our business
plan.
If we
cannot obtain the necessary capital, we will have to:
|
•
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engage
in equity financings that would result in significant dilution to existing
investors;
|
|
•
|
delay
or reduce the scope of or eliminate one or more of our development
programs;
|
|
•
|
obtain
funds through arrangements with collaborators or others that may require
us to relinquish rights to technologies, product candidates or products
that we would otherwise seek to develop or commercialize ourselves; or
license rights to technologies, product candidates or products on terms
that are less favourable to us than might otherwise be available;
or
|
|
•
|
considerably
reduce, even cease our operations
|
We
have a history of operating losses. We expect to incur net losses and we may
never achieve or maintain profitability.
We have
not been profitable since our inception in 1986. We reported net losses of $6.3
million; $9.6 million and $17.9 million for the years ended May 31, 2008, 2007
and 2006, respectively. As of May 31, 2008, we had an accumulated deficit of
$180.5 million.
To date
we have only generated nominal revenues from the sale of Virulizin® in Mexico
and we stopped selling Virulizin® in Mexico in July 2005. We have not generated
any other revenue from product sales to date and it is possible that we will
never have sufficient product sales revenue to achieve profitability. We expect
to continue to incur losses for at least the next several years as we or our
collaborators and licensees pursue clinical trials and research and development
efforts. To become profitable, we, either alone or with our collaborators and
licensees, must successfully develop, manufacture and market our current product
candidates, LOR-2040, as well as continue to identify, develop, manufacture and
market new product candidates. It is possible that we will never have
significant product sales revenue or receive significant royalties on our
licensed product candidates. If funding is insufficient at any time in the
future, we may not be able to develop or commercialize our products, take
advantage of business opportunities or respond to competitive
pressures.
We
are an early stage development company
We are
at an early stage of development. Significant additional investment will be
necessary to complete the development of any of our products. Pre-clinical and
clinical trial work must be completed before our products could be ready for use
within the market that we have identified. We may fail to develop any products,
to obtain regulatory approvals, to enter clinical trials or to commercialize any
products. We do not know whether any of our potential product development
efforts will prove to be effective, meet applicable regulatory standards, obtain
the requisite regulatory approvals, be capable of being manufactured at a
reasonable cost or be accepted in the marketplace.
The
product candidates we are currently developing are not expected to be
commercially viable for several years and we may encounter unforeseen
difficulties or delays in commercializing our product candidates. In addition,
our products may cause undesirable side effects.
Our
product candidates require significant funding to reach regulatory approval
assuming positive clinical results. Such funding will be very
difficult, or impossible to raise in the public markets. If such
partnerships are not attainable, the development of these product candidates
maybe significantly delayed or stopped altogether. The announcement
of such delay or discontinuation of development may have a negative impact on
our share price.
Our
cash flow is not sufficient to repay our debentures at maturity.
Our
ability to repay our convertible debentures at maturity or refinance our prime
plus 1% convertible debentures due in approximately 14 months (October 2009)
will depend on our ability to generate or raise sufficient cash or refinance
them. If we cannot repay or refinance the debentures at or prior to maturity,
the lender may, at its discretion:
|
•
|
take
possession of our assets;
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|
•
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appoint
a receiver; and
|
|
•
|
take
any other action permitted by law to obtain
payment.
|
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.
Our
convertible debentures are subject to certain operational
covenants. In the event that one of those covenants is breached by
us, an event of default could be declared requiring the immediate payment of the
face value of the debentures. This could result in our inability to
pay the principal and interest owing on the debentures and insolvency of the
Company, a dilutive equity financing in attempt to raise funds to repay the
debentures, or a significant reduction in cash available for us to use towards
the development of our product candidates.
The
Company has indemnified Old Lorus and its directors, officers and employees in
respect of the Arrangement.
Under
the Arrangement, we 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.
|
This
indemnification could result in significant liability to us.
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.
Our
strategy for the research, development and commercialization of our products
requires entering into various arrangements with corporate collaborators,
licensers, licensees and others, and our commercial success is dependent upon
these outside parties performing their respective contractual responsibilities.
The amount and timing of resources that such third parties will devote to these
activities may not be within our control. We cannot assure you that such parties
will perform their obligations as expected. We also cannot assure you that our
collaborators will devote adequate resources to our programs. In addition, we
could become involved in disputes with our collaborators, which could result in
a delay or termination of the related development programs or result in
litigation. We intend to seek additional collaborative arrangements to develop
and commercialize some of our products. We may not be able to negotiate
collaborative arrangements on favourable terms, or at all, in the future, or
that our current or future collaborative arrangements will be
successful.
If we
cannot negotiate collaboration, licence or partnering agreements, we may never
achieve profitability.
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.
None of
our product candidates has received regulatory approval for commercial use and
sale in North America. We cannot market a pharmaceutical product in any
jurisdiction until it has completed thorough preclinical testing and clinical
trials in addition to that jurisdiction’s extensive regulatory approval process.
In general, significant research and development and clinical studies are
required to demonstrate the safety and effectiveness of our product candidates
before we can submit any regulatory applications.
Clinical
trials are long, expensive and uncertain processes. Clinical trials may not be
commenced or completed on schedule, and Health Canada or the FDA or any other
regulatory body may not ultimately approve our product candidates for commercial
sale.
The
clinical trials of any of our drug candidates could be unsuccessful, which would
prevent us from advancing, commercializing or partnering the drug.
Even if
the results of our preclinical studies or clinical trials are initially
positive, it is possible that we will obtain different results in the later
stages of drug development or that results seen in clinical trials will not
continue with longer term treatment. Positive results in early Phase I or Phase
II clinical trials may not be repeated in larger Phase II or Phase III clinical
trials. For example, results of our Phase III clinical trial of
Virulizinâ did not
meet the primary endpoint of the study despite promising preclinical and early
stage clinical data. All of our potential drug candidates are prone
to the risks of failure inherent in drug development.
Preparing,
submitting and advancing applications for regulatory approval is complex,
expensive and time intensive and entails significant uncertainty. A commitment
of substantial resources to conduct time-consuming research, preclinical studies
and clinical trials will be required if we are to complete development of our
products.
Clinical
trials of our products require that we identify and enrol a large number of
patients with the illness under investigation. We may not be able to enrol a
sufficient number of appropriate patients to complete our clinical trials in a
timely manner particularly in smaller indications such as acute myeloid
leukemia. If we experience difficulty in enrolling a sufficient
number of patients to conduct our clinical trials, we may need to delay or
terminate ongoing clinical trials and will not accomplish objectives material to
our success that could affect the price of our common shares. Delays in planned
patient enrolment or lower than anticipated event rates in our current clinical
trials or future clinical trials may result in increased costs, program delays,
or both.
In
addition, unacceptable toxicities or adverse side effects may occur at any time
in the course of preclinical studies or human clinical trials or, if any product
candidates are successfully developed and approved for marketing, during
commercial use of any approved products. The appearance of any such unacceptable
toxicities or adverse side effects could interrupt, limit, delay or abort the
development of any of our product candidates or, if previously approved,
necessitate their withdrawal from the market. Furthermore, disease resistance or
other unforeseen factors may limit the effectiveness of our potential
products.
Our
failure to develop safe, commercially viable drugs would substantially impair
our ability to generate revenues and sustain our operations and would materially
harm our business and adversely affect our share price. We may never achieve
profitability.
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.
Many of
our competitors have:
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•
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drug
products that have already been approved or are in development, and
operate large, well-funded research and development programs in these
fields;
|
|
•
|
substantially
greater financial and management resources, stronger intellectual property
positions and greater manufacturing, marketing and sales capabilities,
areas in which we have limited or no
experience;
|
|
•
|
significantly
greater experience than we do in undertaking preclinical testing and
clinical trials of new or improved pharmaceutical products and obtaining
required regulatory approvals;
|
|
•
|
Consequently,
our competitors may obtain Health Canada, FDA and other regulatory
approvals for product candidates sooner and may be more successful in
manufacturing and marketing their products than we or our collaborators
are;
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•
|
Existing
and future products, therapies and technological approaches will compete
directly with the products we seek to develop. Current and prospective
competing products may provide greater therapeutic benefits for a specific
problem or may offer easier delivery or comparable performance at a lower
cost.;
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|
•
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Any
product candidate that we develop and that obtains regulatory approval
must then compete for market acceptance and market share. Our product
candidates may not gain market acceptance among physicians, patients,
healthcare payers and the medical community. Further, any products we
develop may become obsolete before we recover any expenses we incurred in
connection with the development of these
products.
|
As a
result, we may never achieve profitability.
If
we fail to attract and retain key employees, the development and
commercialization of our products may be adversely affected.
We
depend heavily on the principal members of our scientific and management staff.
If we lose any of these persons, our ability to develop products and become
profitable could suffer. The risk of being unable to retain key personnel may be
increased by the fact that we have not executed long term employment contracts
with our employees, except for our senior executives. Our future success will
also depend in large part on our ability to attract and retain other highly
qualified scientific and management personnel. We face competition for personnel
from other companies, academic institutions, government entities and other
organizations.
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.
Patent
protection:
The
patent positions of pharmaceutical and biotechnology companies are uncertain and
involve complex legal and factual questions.
The
United States (U.S.) Patent and Trademark Office and many other patent offices
in the world have not established a consistent policy regarding the breadth of
claims that they will allow in biotechnology patents.
Allowable
patentable subject matter and the scope of patent protection obtainable may
differ between jurisdictions. If a patent office allows broad claims,
the number and cost of patent interference proceedings in the U.S. or analogous
proceedings in other jurisdictions and the risk of infringement litigation may
increase. If it allows narrow claims, the risk of infringement may decrease, but
the value of our rights under our patents, licenses and patent applications may
also decrease.
The
scope of the claims in a patent application can be significantly modified during
prosecution before the patent is issued. Consequently, we cannot know whether
our pending applications will result in the issuance of patents or, if any
patents are issued, whether they will provide us with significant proprietary
protection or will be circumvented, invalidated or found to be
unenforceable.
Until
recently, patent applications in the U.S. were maintained in secrecy until the
patents issued, and publication of discoveries in scientific or patent
literature often lags behind actual discoveries. Patent applications filed in
the United States after November 2000 generally will be published 18 months
after the filing date unless the applicant certifies that the invention will not
be the subject of a foreign patent application. In many other
jurisdictions, such as Canada, patent applications are published 18 months from
the priority date. We cannot assure you that, even if published, we
will be aware of all such literature. Accordingly, we cannot be certain that the
named inventors of our products and processes were the first to invent that
product or process or that we were the first to pursue patent coverage for our
inventions.
Enforcement
of intellectual property rights:
Protection
of the rights revealed in published patent applications can be complex, costly
and uncertain. Our commercial success depends in part on our ability
to maintain and enforce our proprietary rights. If third parties engage in
activities that infringe our proprietary rights, our management’s focus will be
diverted and we may incur significant costs in asserting our rights. We may not
be successful in asserting our proprietary rights, which could result in our
patents being held invalid or a court holding that the third party is not
infringing, either of which would harm our competitive position.
Others
may design around our patented technology. We may have to participate in
interference proceedings declared by the U.S. Patent and Trademark Office,
European opposition proceedings, or other analogous proceedings in other parts
of the world to determine priority of invention and the validity of patent
rights granted or applied for, which could result in substantial cost and delay,
even if the eventual outcome is favourable to us. We cannot assure you that our
pending patent applications, if issued, would be held valid or
enforceable.
Trademark
protection:
In
order to protect goodwill associated with our company and product names, we rely
on trademark protection for our marks. For example, we have registered the
Virulizin® trademark with the U.S. Patent and Trademark Office. A third party
may assert a claim that the Virulizin® mark is confusingly similar to its mark
and such claims or the failure to timely register the Virulizin® mark or
objections by the FDA could force us to select a new name for Virulizin®, which
could cause us to incur additional expense.
Trade
secrets:
We also
rely on trade secrets, know-how and confidentiality provisions in our agreements
with our collaborators, employees and consultants to protect our intellectual
property. However, these and other parties may not comply with the terms of
their agreements with us, and we might be unable to adequately enforce our
rights against these people or obtain adequate compensation for the damages
caused by their unauthorized disclosure or use of our trade secrets or know how.
Our trade secrets or those of our collaborators may become known or may be
independently discovered by others.
Our
products and product candidates may infringe the intellectual property rights of
others, which could increase our costs.
Our
success also depends on avoiding infringement of the proprietary technologies of
others. In particular, there may be certain issued patents and patent
applications claiming subject matter which we or our collaborators may be
required to license in order to research, develop or commercialize at least some
of our product candidates, including Virulizin®, LOR-2040 and small molecules.
In addition, third-parties may assert infringement or other intellectual
property claims against us based on our patents or other intellectual property
rights. An adverse outcome in these proceedings could subject us to significant
liabilities to third-parties, require disputed rights to be licensed from
third-parties or require us to cease or modify our use of the technology. If we
are required to license such technology, we cannot assure you that a license
under such patents and patent applications will be available on acceptable terms
or at all. Further, we may incur substantial costs defending ourselves in
lawsuits against charges of patent infringement or other unlawful use of
another’s proprietary technology.
If
product liability claims are brought against us or we are unable to obtain or
maintain product liability insurance, we may incur substantial liabilities that
could reduce our financial resources.
The
clinical testing and commercial use of pharmaceutical products involves
significant exposure to product liability claims. We have obtained limited
product liability insurance coverage for our clinical trials on humans; however,
our insurance coverage may be insufficient to protect us against all product
liability damages. Further, liability insurance coverage is becoming
increasingly expensive and we might not be able to obtain or maintain product
liability insurance in the future on acceptable terms or in sufficient amounts
to protect us against product liability damages. Regardless of merit or eventual
outcome, liability claims may result in decreased demand for a future product,
injury to reputation, withdrawal of clinical trial volunteers, loss of revenue,
costs of litigation, distraction of management and substantial monetary awards
to plaintiffs. Additionally, if we are required to pay a product liability
claim, we may not have sufficient financial resources to complete development or
commercialization of any of our product candidates and our business and results
of operations will be adversely affected.
We
have no manufacturing capabilities. We depend on third-parties, including a
number of sole suppliers, for manufacturing and storage of our product
candidates used in our clinical trials. Product introductions may be delayed or
suspended if the manufacture of our products is interrupted or
discontinued.
We do
not have manufacturing facilities to produce supplies of LOR-2040, small
molecule or any of our other product candidates to support clinical trials or
commercial launch of these products, if they are approved. We are dependent on
third parties for manufacturing and storage of our product candidates. If we are
unable to contract for a sufficient supply of our product candidates on
acceptable terms, or if we encounter delays or difficulties in the manufacturing
process or our relationships with our manufacturers, we may not have sufficient
product to conduct or complete our clinical trials or support preparations for
the commercial launch of our product candidates, if approved.
Our
operations involve hazardous materials and we must comply with environmental
laws and regulations, which can he expensive and restrict how we do
business.
Our
research and development activities involve the controlled use of hazardous
materials, radioactive compounds and other potentially dangerous chemicals and
biological agents. Although we believe our safety procedures for these materials
comply with governmental standards, we cannot entirely eliminate the risk of
accidental contamination or injury from these materials. We currently have
insurance, in amounts and on terms typical for companies in businesses that are
similarly situated, that could coverall or a portion of a damage claim arising
from our use of hazardous and other materials. However, if an accident or
environmental discharge occurs, and we are held liable for any resulting
damages, the associated liability could exceed our insurance coverage and our
financial resources.
Our
interest income is subject to fluctuations of interest rates in our investment
portfolio.
Our
investments are held to maturity and have staggered maturities to minimize
interest rate risk. We cannot assure you that interest income fluctuations will
not have an adverse impact on our financial condition. We maintain all our
accounts in Canadian dollars, but a portion of our expenditures are in foreign
currencies. We do not currently engage in hedging our foreign currency
requirements to reduce exchange rate risk.
RISKS
RELATED TO OUR COMMON SHARES AND CONVERTIBLE DEBENTURES
Our
share price has been and may continue to be volatile and an investment in our
common shares could suffer a decline in value.
You
should consider an investment in our common shares as risky and invest only if
you can withstand a significant loss and wide fluctuations in the market value
of your investment. We receive only limited attention by securities analysts and
frequently experience an imbalance between supply and demand for our common
shares. The market price of our common shares has been highly volatile and is
likely to continue to be volatile. Factors affecting our common share price
include but are not limited to:
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•
|
the
progress of our and our collaborators’ clinical trials, including our and
our collaborators’ ability to produce clinical supplies of our product
candidates on a timely basis and in sufficient quantities to meet our
clinical trial requirements;
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•
|
announcements
of technological innovations or new product candidates by us, our
collaborators or our competitors;
|
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•
|
fluctuations
in our operating results;
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•
|
published
reports by securities analysts;
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•
|
developments
in patent or other intellectual property
rights;
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•
|
publicity
concerning discovery and development activities by our
licensees;
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•
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the
cash and short term investments held us and our ability to secure future
financing;
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•
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public
concern as to the safety and efficacy of drugs that we and our competitors
develop;
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•
|
governmental
regulation and changes in medical and pharmaceutical product reimbursement
policies; and
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•
|
general
market conditions.
|
Future
sales of our common shares by us or by our existing shareholders could cause our
share price to fall.
Additional
equity financings or other share issuances by us could adversely affect the
market price of our common shares. Sales by existing shareholders of a large
number of shares of our common shares in the public market and the sale of
shares issued in connection with strategic alliances, or the perception that
such additional sales could occur, could cause the market price of our common
shares to drop.
Conversion
of our secured convertible debentures will dilute the ownership interest of
existing shareholders.
The
conversion of some or all of our convertible debentures will dilute the
ownership interests of existing shareholders. Any sales in the public market of
the common shares issuable upon such conversion could adversely affect
prevailing market prices of our common shares. In addition, the existence of the
secured convertible debentures may encourage short selling by market
participants.
We
maybe unable to maintain the listing requirements on one or more of the stock
exchanges our shares are currently listed on.
We are
currently not in compliance with the listing standards of the
AMEX. We have been granted 18 months by the AMEX to regain compliance
based on a business plan approved by the AMEX in May 2008. We may be
unable to reach or sustain the listing requirements which would result in our
shares being delisted from the exchange. This would result in our
shareholders only being able to trade shares on the Toronto Stock
Exchange.
CRITICAL
ACCOUNTING POLICIES
|
The
Company periodically reviews its financial reporting and disclosure practices
and accounting policies to ensure that they provide accurate and transparent
information relative to the current economic and business environment. As part
of this process, the Company has reviewed its selection, application and
communication of critical accounting policies and financial disclosures.
Management has discussed the development and selection of the critical
accounting policies with the Audit Committee of the Board of Directors and the
Audit Committee has reviewed the disclosure relating to critical accounting
policies in this MD&A. Other important accounting polices are described in
note 2 of the Financial Statements.
Drug
Development Costs
We
incur costs related to the research and development of pharmaceutical products
and technologies for the management of cancer. These costs include internal and
external costs for preclinical research and clinical trials, drug costs,
regulatory compliance costs and patent application costs. All research costs are
expensed as incurred as required under GAAP.
Development
costs, including the cost of drugs for use in clinical trials, are expensed as
incurred unless they meet the criteria under GAAP for deferral and amortization.
The Company continually assesses its activities to determine when, if ever,
development costs may qualify for capitalization. By expensing the research and
development costs as required under GAAP, the value of the product portfolio is
not reflected on the Company's Financial Statements.
Stock-Based
Compensation
We have
applied the fair value based method to expense stock options awarded since June
1, 2002 using the Black-Scholes option-pricing model as allowed under Canadian
Institute of Chartered Accountants (“CICA”) Handbook Section 3870. The model
estimates the fair value of fully transferable options, without vesting
restrictions, which significantly differs from the stock option awards issued by
Lorus. The model also requires four highly subjective assumptions including
future stock price volatility and expected time until exercise, which greatly
affect the calculated values. The increase or decrease of one of these
assumptions could materially increase or decrease the fair value of stock
options issued and the associated expense.
Valuation
Allowance for Future Tax Assets
We have
a net tax benefit resulting from non-capital losses carried forward, and
scientific research and experimental development expenditures. In light of the
continued net losses and uncertainty regarding our future ability to generate
taxable income, management is of the opinion that it is not more likely than not
that these tax assets will be realized in the foreseeable future and hence, a
full valuation allowance has been recorded against these income tax assets.
Consequently, no future income tax assets or liabilities are recorded on the
balance sheets.
The
generation of future taxable income could result in the recognition of some
portion or all of the remaining benefits, which could result in an improvement
in our results of operations through the recovery of future income
taxes.
Valuation
of Long Lived Assets
We
periodically review the useful lives and the carrying values of our long-lived
assets. We review for impairment in long-lived assets whenever events or changes
in circumstances indicate that the carrying amount of the assets may not be
recoverable. If the sum of the undiscounted future cash flows expected to result
from the use and eventual disposition of an asset is less than its carrying
amount, it is considered to be impaired. An impairment loss is measured at the
amount by which the carrying amount of the asset exceeds its fair value; which
is estimated as the expected future cash flows discounted at a rate commensurate
with the risks associated with the recovery of the asset.
ACCOUNTING
POLICY CHANGES
Effective
on June 1, 2007, the Company adopted the recommendations of CICA Handbook
Section 1530, Comprehensive Income; Section 3855, Financial Instruments -
Recognition and Measurement; Section 3861, Financial Instruments - Disclosure
and Presentation; and Section 3251, Equity. These sections provide
standards for recognition, measurement, disclosure and presentation of financial
assets, financial liabilities and non-financial derivatives. Section 1530
provides standards for the reporting and presentation of comprehensive income,
which represents the change in equity, from transactions and other events and
circumstances from non-owner sources. Other comprehensive income
refers to items recognized in comprehensive income that are excluded from net
income calculated in accordance with Canadian GAAP.
Our
adoption of the above recommendations had the following impact on the current
financial statements:
Short-term
investments:
Short-term
investments consist of fixed income government investments and corporate
instruments. Any government and corporate investments with a stated maturity
date that are not cash equivalents are classified as held-to-maturity
investments, except where the Company does not intend to hold to maturity and,
therefore, the investment is designated as held-for-trading. Held-to-maturity
investments are measured at amortized cost using the effective interest rate
method, while held-for-trading investments are measured at fair value and the
resulting gain or loss is recognized in the consolidated statements of
operations. The Company designated certain corporate instruments with maturities
greater than one year previously carried at amortized cost as held-for-trading
investments. This change in accounting policy resulted in a decrease in the
carrying amount of $27 thousand and an increase in the opening deficit
accumulated during the development stage of $27 thousand. The Company recognized
a net unrealized gain in the consolidated statements of operations for the year
ended May 31, 2008 of $7 thousand.
Secured
convertible debentures:
The
secured convertible debentures are classified as other financial liabilities and
accounted for at amortized cost using the effective interest method, which is
consistent with the Company's accounting policy prior to the adoption of Section
3855. The deferred financing charges related to the secured convertible
debentures, formerly included in long term assets, are now included as part of
the carrying value of the secured convertible debentures and continue to be
amortized using the effective interest method.
Embedded
derivatives:
Section
3855 requires that the Company identify embedded derivatives that require
separation from the related host contract and measure those embedded derivatives
at fair value. Subsequent change in fair value of embedded
derivatives is recognized in the consolidated statement of operations and
deficit in the period the change occurs.
The
Company did not identify any embedded derivatives that required separation from
the related host contract as at June 1, 2007 that resulted in a material
adjustment to the consolidated interim financial statements.
Transaction
costs:
Transaction
costs that are directly attributable to the acquisition or issuance of financial
assets or liabilities are accounted for as part of the respective asset or
liability's carrying value at inception except for held-for-trading securities
where the costs are expensed immediately.
Guarantee:
On July
10, 2007, as part of the Arrangement, the Company, including its subsidiaries,
indemnified Old Lorus and its directors. This indemnity is required
to be accounted for at fair value in accordance with Section
3855. Management has accrued an amount of $600 thousand being the
amount held in escrow and has recorded this amount as a deferred gain on sale of
shares within its liabilities. The fair value of the indemnity will
be reassessed in the first quarter 2009 as the escrowed amount was released on
July 2008.
There
were no new accounting policies implemented during the year-end May 31,
2007. The following changes were implemented in 2006:
Variable
Interest Entities
Effective
June 1, 2005, the Company adopted the recommendations of CICA Handbook
Accounting Guideline 15 (AcG-15), Consolidation of Variable Interest
Entities, effective for fiscal years beginning on or after November 1,
2004. Variable interest entities (VIEs) refer to those entities that are subject
to control on a basis other than ownership of voting interests. AcG-15 provides
guidance for identifying VIEs and criteria for determining which entity, if any,
should consolidate them. The adoption of AcG-15 did not have an
effect on the financial position, results of operations or cash flows in the
current period or the prior period presented.
Financial
Instruments - Disclosure and Presentation
Effective
June 1, 2005, the Company adopted the amended recommendations of CICA Handbook
Section 3860, Financial
Instruments - Disclosure and Presentation, effective for fiscal years
beginning on or after November 1, 2004. Section 3860 requires that certain
obligations that may be settled at the issuer’s option in cash or the equivalent
value by a variable number of the issuer’s own equity instruments be presented
as a liability. The Company has determined that there is no impact on the
Financial Statements resulting from the adoption of the amendments to Section
3860 either in the current period or the prior period presented.
Accounting
for Convertible Debt Instruments
On
October 17, 2005, the CICA issued EIC 158, Accounting for Convertible Debt
Instruments applicable to convertible debt instruments issued subsequent
to the date of the EIC. EIC 158 discusses the accounting treatment of
convertible debentures in which upon conversion, the issuer is either required
or has the option to satisfy all or part of the obligation in
cash. The EIC discusses various accounting issues related to this
type of convertible debt. The Company has determined that there is no
impact on the Financial Statements resulting from the adoption of EIC 158 either
in the current period or the prior period presented.
Section
3831, Non-Monetary Transactions
In June
2005, the CICA released a new Handbook Section 3831, Non-monetary Transactions,
effective for all non-monetary transactions initiated in periods beginning on or
after January 1, 2006. This standard requires all non-monetary transactions to
be measured at fair value unless they meet one of four very specific criteria.
Commercial substance replaces culmination of the earnings process as the test
for fair value measurement. A transaction has commercial substance if it causes
an identifiable and measurable change in the economic circumstances of the
entity. Commercial substance is a function of the cash flows expected by the
reporting entity.
RECENT
ACCOUNTING
PRONOUNCEMENTS
|
In
October 2006, the AcSB approved disclosure and presentation requirements for
financial instruments that revise and enhance the disclosure requirements of
Section 3861. These requirements included Sections 3862 - Financial
Instruments - Disclosure, which replaces Section 3861 and Section 1535, Capital
Disclosures ("Section 1535"), which establishes standards for disclosing
information about an entity's capital and how it is managed.
Section
3862 is based on IFRS 7, “Financial Instruments: Disclosures”, and places an
increased emphasis on disclosures about the risks associated with both
recognized and unrecognized financial instruments and how these risks are
managed. Section 3862 requires disclosures, by class of financial
instrument that enables users to evaluate the significance of financial
instruments for an entity's financial position and performance, including
disclosures about fair value. In addition, disclosure is required of qualitative
and quantitative information about exposure to risks arising from financial
instruments, including specified minimum disclosures about credit risk,
liquidity risk and market risk. The quantitative disclosures must also include a
sensitivity analysis for each type of market risk to which an entity is exposed,
showing how net income and other comprehensive income would have been affected
by reasonably possible changes in the relevant risk variable.
Section
3863 “Financial Instruments - Presentation”, which replaces Section 3861,
“Financial Instruments - Disclosure and Presentation”. The existing requirements
on presentation of financial instruments have been carried forward unchanged to
Section 3863, “Financial Instruments - Presentation”.
These
new Sections are effective for interim and annual financial statements with
fiscal years beginning on or after October 1, 2007, but may be adopted in place
of Section 3861 before that date.
Section
1535 requires disclosure of an entity's objectives, policies and processes for
managing capital, quantitative data about what the entity regards as capital and
whether the entity has complied with any capital requirements and, if it has not
complied, the consequences of such non-compliance. This standard is
effective for us for interim and annual financial statements relating to fiscal
years beginning on December 1, 2007. Early adoption is permitted at the same
time an entity adopts other standards relating to accounting for financial
instruments.
We do
not expect the adoption of these standards to have a material impact on our
consolidated financial position and results of operations.
CICA
Handbook Section 1400, “General Standards on Financial Statement Presentation”,
has been amended to include requirements to assess and disclose an entity’s
ability to continue as a going concern. The changes are effective for the
Company for interim and annual financial statements beginning on or after
January 1, 2008, and specifically June 1, 2008 for the Company. We
have not yet assessed the impact, if any, of Section 1400 on the Company’s
financial statements.
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.
SELECTED
ANNUAL FINANCIAL DATA
The
following selected consolidated financial data have been derived from, and
should be read in conjunction with, the accompanying audited consolidated
financial statements for the year ended May 31, 2008 which are prepared in
accordance with Canadian GAAP.
Consolidated
Statements of Loss and Deficit
|
(amounts
in Canadian 000's except for per common share
data)
|
|
|
Years
Ended May 31
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
REVENUE
|
|
$ |
43 |
|
|
$ |
107 |
|
|
$ |
26 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of sales
|
|
|
2 |
|
|
|
16 |
|
|
|
3 |
|
Research
and development
|
|
|
6,087 |
|
|
|
3,384 |
|
|
|
10,237 |
|
General
and administrative
|
|
|
3,888 |
|
|
|
3,848 |
|
|
|
4,334 |
|
Stock-based
compensation
|
|
|
719 |
|
|
|
503 |
|
|
|
1,205 |
|
Depreciation
and amortization
|
|
|
317 |
|
|
|
402 |
|
|
|
771 |
|
Operating
expenses
|
|
|
11,013 |
|
|
|
8,153 |
|
|
|
16,550 |
|
Interest
expense on convertible debentures
|
|
|
1,029 |
|
|
|
1,050 |
|
|
|
882 |
|
Accretion
in carrying value of secured convertible debentures
|
|
|
1,176 |
|
|
|
935 |
|
|
|
790 |
|
Amortization
of deferred financing charges
|
|
|
- |
|
|
|
110 |
|
|
|
87 |
|
Interest
income
|
|
|
(542 |
) |
|
|
(503 |
) |
|
|
(374 |
) |
Loss
from operation for the period
|
|
|
12,633 |
|
|
|
9,638 |
|
|
|
17,909 |
|
Gain
on sale of shares
|
|
|
(6,299 |
) |
|
|
- |
|
|
|
- |
|
Net
loss and other comprehensive income
|
|
|
6,334 |
|
|
|
9,638 |
|
|
|
17,909 |
|
Basic
and diluted loss per common share
|
|
$ |
0.03 |
|
|
$ |
0.05 |
|
|
$ |
0.10 |
|
Weighted
average number of common shares outstanding used in the
calculation of basic and diluted loss per share
|
|
|
215,084 |
|
|
|
204,860 |
|
|
|
173,523 |
|
Total
Assets
|
|
$ |
11,607 |
|
|
$ |
15,104 |
|
|
$ |
11,461 |
|
Total
Long-term liabilities
|
|
$ |
12,742 |
|
|
$ |
11,566 |
|
|
$ |
10,521 |
|
QUARTERLY
RESULTS OF OPERATIONS
|
The
following table sets forth certain unaudited consolidated statements of
operations data for each of the eight most recent fiscal quarters that, in
management's opinion, have been prepared on a basis consistent with the audited
consolidated financial statements contained elsewhere in this annual report and
includes all adjustments, consisting only of normal recurring adjustments,
necessary for a fair presentation of the information presented.
Research
and development expenses have increased during 2008 in comparison with the same
quarters in the prior year. This increased spending is the result of
the initiation of a Phase II clinical trial with LOR-2040 for the treatment of
AML and the related purchase of needed drug supply as well as the escalation of
our small molecule program and LOR-2040 for the treatment of bladder cancer into
GLP-toxicology studies. Research and development costs decreased
throughout 2007 as the remaining costs of the Phase III Virulizin® clinical
trial were completed and the escalation of our current programs underway had not
yet begun.
General
and administrative expenses have remained relatively consistent across quarters
in the current fiscal year with the exception of an increase for the quarters
ended November 30, 2007 and May 31, 2008. The increase in the second
quarter ended November 30, 2007 was due to higher annual meeting costs
associated with a special meeting and the amendment of our stock option
plan. The increase in Q4 compared with the prior year was
predominantly the result of increased legal activity associated with a licensing
transaction completed during the quarter and employment litigation which was
resolved during Q4. In addition costs were incurred in the
preparation for compliance with internal controls requirements. General and
administrative expenses increased significantly in the quarter ended November
30, 2006 due to severance charges relating to the mutual separation agreement
executed in September as described in the Corporate Changes section,
above.
Net
loss increased in Q3 and Q4 2008 due to an increase in research and development
costs. We had net income in Q1 due to the Gain on Sale of Shares as
described above. Net loss decreased in Q3 and Q4 of 2007 as the
result of reduced research and development and general and administrative
expenditures.
|
|
Fiscal
2008
Quarter
Ended
|
|
|
Fiscal
2007
Quarter
Ended
|
|
(Amounts
in 000’s except for per common share data)
|
|
May
31, 2008
|
|
|
Feb.
29, 2008
|
|
|
Nov.
30, 2007
|
|
|
Aug.
31, 2007
|
|
|
May
31, 2007
|
|
|
Feb.
28, 2007
|
|
|
Nov.
30, 2006
|
|
|
Aug.
31, 2006
|
|
Revenue
|
|
$ |
13 |
|
|
$ |
3 |
|
|
$ |
1 |
|
|
$ |
26 |
|
|
$ |
40 |
|
|
$ |
37 |
|
|
$ |
23 |
|
|
$ |
7 |
|
Research
and development
|
|
|
1,836 |
|
|
|
2,222 |
|
|
|
1,247 |
|
|
|
782 |
|
|
|
259 |
|
|
|
672 |
|
|
|
1,122 |
|
|
|
1,331 |
|
General
and administrative
|
|
|
1,186 |
|
|
|
863 |
|
|
|
1,103 |
|
|
|
736 |
|
|
|
820 |
|
|
|
833 |
|
|
|
1,407 |
|
|
|
788 |
|
Net
loss
|
|
|
(3,650 |
) |
|
|
(3,850 |
) |
|
|
(2,825 |
) |
|
|
3,991 |
|
|
|
(1,689 |
) |
|
|
(2,062 |
) |
|
|
(3,117 |
) |
|
|
(2,770 |
) |
Basic
and diluted net loss per share
|
|
$ |
(0.02 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.01 |
) |
|
$ |
0.02 |
|
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
used in operating activities
|
|
$ |
(2,722 |
) |
|
$ |
(2,586 |
) |
|
$ |
(2,537 |
) |
|
$ |
(2,348 |
) |
|
$ |
(89 |
) |
|
$ |
(1,805 |
) |
|
$ |
(2,585 |
) |
|
$ |
(1,814 |
) |
Disclosure
Controls and Procedures
As at
May 31, 2008, Lorus 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
there are no material weaknesses in the design and operation of its disclosure
controls and that these disclosure controls and procedures are
effective.
In July
2008 we released a press release which contained certain clerical
errors. We identified the errors quickly and circulated a correct
version of the press release within a few hours. We have reviewed the
process and put controls in place to ensure that such errors will not happen in
the future.
Internal
Controls Over Financial Reporting
Management
is responsible for certifying the design of our internal control over financial
reporting as required by Multilateral Instrument 52-109 - Certification of
Disclosure in Issuers’ Annual and Interim Filings as well as certifying to the
design and testing of our internal controls over financial reporting as required
under Sarbanes Oxley Section 404. The year ended May 31, 2008 was the
first year we have been required to perform detailed testing of our internal
controls over financial reporting. As a result of this more detailed
level of evaluating and testing our internal controls over financial reporting
as at May 31, 2008, management has concluded that the following disclosable
weaknesses existed at May 31, 2008.
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.
Changes
in Controls
There
have been no significant changes in our internal controls over financial
reporting during the year ended May 31, 2008, that have materially affected, or
are reasonably likely to materially affect our’ internal control over financial
reporting.
As at
August 28, 2008, the Company had 247,354,622 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 20,475,000 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).