Exhibit
99.2
MANAGEMENT’S DISCUSSION AND
ANALYSIS
April 14, 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, preclinical 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;
and
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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,
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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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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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the progress of our clinical
trials;
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our ability to find and enter
into agreements with potential
partners;
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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 annual information form 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 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 interim
consolidated financial statements are those of Old Lorus. References
in this 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,
2007 and the accompanying notes for 6650309 Canada Inc., subsequently renamed
Lorus Therapeutics Inc., (New Lorus) and the financial statements of Lorus
Therapeutics Inc. subsequently renamed 4325231 Canada Inc., (Old Lorus)
presented in the Supplemental Financial Information (collectively 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.
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 multiple Phase I and II clinical
trials. 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.
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 establishing the efficacy and safety of our products in
clinical trials, securing strategic partnerships, and maintaining sufficient
levels of funding through public and/or private financing.
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
loss from operations for the three-month period ended February 29, 2008
increased to $3.8 million ($0.02 per share) compared with a net loss of $2.1
million ($0.01 per share) during the same period in fiscal 2007. For the
nine-month period ended February 29, 2008 our loss from operations, excluding
the gain on sale relating to the Arrangement, increased to $9.0 million from
$7.9 million in the same period last year. On the close of the
Arrangement, in July 2007, the Company realized a gain on the sale of the shares
of Old Lorus in the amount of $6.3 million resulting in a net loss for the
nine-month period of $2.7 million ($0.01 per share). The gain on sale of the shares was
reduced by $11 thousand in the quarter reflecting an increase in transaction
costs.
We
utilized cash of $7.5 million in our operating activities in nine-month period
ended February 29, 2008 compared with $6.2 million during the same period in
fiscal 2007 reflecting the increase in net loss during the nine month
period. At February 29, 2008, we had cash and cash equivalents and
marketable securities of $12.2 million compared to $12.4 million at May 31,
2007.
Revenues for the three-month period
ended February 29, 2008 decreased to $3 thousand compared with revenue of $37
thousand for the same period last year. For the nine-month period
ended February 29, 2008, total revenue decreased to $30 thousand from $67
thousand in the same period last year. This decrease in revenue is
related to a reduction in laboratory services work performed by Lorus personnel
on behalf of other companies.
Research and development expenses
totaled $2.2 million in the three-month period ended February 29, 2008 compared to $672 thousand during the
same period last year and increased to $4.3 million from $3.1 million in the
nine month period ended February 29, 2008 as compared to the same period in
fiscal 2007.
For the three-month period ended
February 29, 2008, research and development expenditures increased by $1.6
million over the prior year resulting from increased activity within our
GTI-2040 and Small Molecule programs. During the three-month period
ended February 29, 2008, we incurred $1.0 million in costs to manufacture additional quantities of
GTI-2040 to support our ongoing Phase II clinical trial in AML as well as an additional $450
thousand in R&D expenditures to support the ongoing GLP toxicity studies in
our pre-clinical programs.
For the nine-month period ended February
29, 2008, research and development expenditures increased by $1.7 million offset
by a decrease in amortization expense related to intangible assets of $655 thousand over the same
period in the previous year for a net increase of $1.1
million. The increase is primarily due to
increased research and testing costs in fiscal 2008 associated with the
advancement of the Company’s small molecule and GTI-2040 programs as well as the
manufacturing costs of $1.0 million associated with the manufacture of additional quantities of
GTI-2040 to support our ongoing Phase II clinical trial in AML.
General and
Administrative
General
and administrative expenses totaled $863 thousand in the three-month period
ended February 29, 2008 compared to $833 thousand in same period last
year. For the nine-month period ended February 29, 2008, general and
administrative expense was $2.7 million compared with $3.0 million in the same
period last year. The decrease in general and administrative costs is
the result of costs incurred in the second quarter of 2007 related to the mutual
separation agreement between the Company and the then President and CEO offset
by costs associated with the recruitment and hiring of the Company’s newly
appointed CFO incurred in the third quarter of 2008.
Stock-Based
Compensation
Stock-based
compensation expense totaled $217 thousand in the three-month period ended
February 29, 2008, compared with $105 thousand in the same period last year and
$529 thousand in the nine-month period ended February 29, 2008 compared with
$368 thousand for the same period last year. The net increase in
stock-based compensation for both these periods is the result of an increase in
options granted during the third quarter of 2008 in order to bring option
granting practices in line with industry standards as well as an expense of $83
thousand in the second quarter of 2008 related to the modification 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.
Depreciation and
Amortization
Depreciation and amortization expenses
decreased to $81 thousand in the three-month period and $240 thousand in the
nine-month period ended February 29, 2008 as compared to $98 thousand and $298
thousand in the same periods, respectively, last year. The decrease in depreciation and
amortization expense is the result of reduced capital asset purchases during
fiscal 2008 and 2007.
Interest Expense
Non-cash interest expense was $258
thousand in the three-month period ended February 29, 2008 compared with $259
thousand in the same period last year. For the nine-month period
ended February 29, 2008 interest expense was $799 thousand compared with $786
thousand for the same period last year. These amounts represent
interest at a rate of prime plus 1% on the $15.0 million convertible
debentures. The interest expense in fiscal 2008 is comparable with
fiscal 2007 as the average prime rates were consistent year over
year. All interest accrued on the debentures to date has been paid in
common shares of the Company.
Accretion in Carrying Value of Secured
Convertible Debentures
Accretion in the carrying value of the
Company’s secured convertible debentures amounted to $285 thousand in the
three-month period ended February 29, 2008 compared with $236 thousand in the same
period last year. For the nine-month period February 29, 2008,
accretion charges were $824 thousand compared to $682 thousand in the same
period in fiscal 2007. The Company has allocated the proceeds from
each tranche of the secured convertible debentures separately to the debt and
equity components of the debentures on a relative fair value
basis. As a result, the debt component of the secured convertible
debentures had an initial cumulative carrying value of $9.8 million as of the
respective 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. Accretion charges are calculated using
the effective interest rate method which results in accretion charges increasing
over the life of the convertible debenture as the accreted balance of the
debentures increases and therefore the related effective interest
charges.
Amortization of Deferred Financing
Charges
Amortization of deferred financing
charges totaled $35 thousand in the three-month period ended February 29, 2008
compared with $27 thousand in the same period last year. Total
deferred financing costs for the nine-month period ended February 29, 2008 were
$101 thousand as compared to $79 thousand in the same period last
year. The deferred financing charges relate to the convertible
debenture transaction and are being amortized using the effective interest rate
method over the five-year life of the debt commencing October 6,
2004.
Interest and Other
Income
Interest income totaled $120 thousand in
the three-month period ended February 29, 2008 compared to $137 thousand in the
same period last year and $435 thousand for the nine month period ended February
29, 2008 and $362 thousand for the comparable period last year. The
amount of interest income in the current fiscal year has been impacted in the
nine-month period by a recognized gain in market value of held-for-trading
classified assets of $4 thousand as a result of the implementation of the new
financial instruments accounting policy, see Recently Adopted
Accounting Policies,
below. The slight decrease in interest income in the current
three-month period is due to a lower average cash and marketable securities
balance. The increase in interest income for the nine month period ended
February 29, 2008 compared with the prior year is due to slightly higher average
cash and marketable securities balances during the first quarter of 2008
compared with the first quarter of 2007 and higher interest rates in the first
and second quarter of 2008 compared with 2007.
Loss from operations for the
period
Operating net loss for the three month
period ended February 29, 2008 increased to $3.8 million or $0.02 per share
compared to $2.1 million or $0.01 per share in the same period last year.
Operating net loss for the nine-month period, before the gain on sale of shares
associated with the completion of the Arrangement, increased to $9.0 million as
compared with $7.9 million in the same period last year. The increase in net
loss in the current three month period as compared to the previous year is
primarily a result of higher research and development costs of $1.6 million and
higher stock based compensation expense of $112 thousand as discussed
above. The increase in net operating loss for the nine-month period
as compared to the prior year is primarily due to higher research and
development costs of $1.1 million inclusive of amortization of acquired R&D
costs fully amortized in fiscal 2007, higher stock based compensation expense of
$161 thousand and higher accretion charges of $142 thousand, offset by lower
general and administrative costs of $326 thousand as discussed
above.
Gain on sale of
shares
As a result of the Arrangement, the
Company recognized a gain on the sale of the shares of Old Lorus to the Investor
of approximately $6.3 million. Under the Arrangement, numerous steps
were undertaken as part of a taxable reorganization. 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.
In reference to those indemnifications,
$600 thousand of the proceeds on the transaction have been held in escrow until
the first anniversary of the transaction (July 2008). The Company has
deferred the entire amount of the proceeds held in escrow as its estimate of any
liability arising from the indemnifications. The Company will further
assess any adjustments required to this obligation when the escrowed amount is
released.
In October 2007, the Company received a
statement of claim in respect of a dispute with a former
employee. The Company believes that the suit is without merit and
will defend the action vigorously. It is currently not possible to
determine the outcome of such action and no provision has been made in the
consolidated interim financial statements.
The Company
received notice from the American Stock Exchange (AMEX) dated February 13, 2008
indicating that the Company 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
Lorus from meeting the minimum stockholder's equity requirement. Pursuant to the
letter, Lorus submitted to AMEX for its review and acceptance, a plan to bring
the Company into compliance with the aforesaid stockholder's equity requirements
within an eighteen-month period. Should this plan not be accepted by AMEX the
Company will be subject to de-listing.
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.
QUARTERLY FINANCIAL INFORMATION
(UNAUDITED)
The selected financial information
provided below is derived from the Company’s unaudited quarterly financial
statements for each of the last eight quarters.
In the three-month period ended February
29, 2008, research and development costs have increased due to the manufacturing
costs associated with producing additional quantities of GTI-2040 to support the
ongoing Phase II clinical trial in AML. Prior to the quarter ended
November 30, 2007 when activity has escalated in our small molecule and GTI-2040
development programs, research and development expenses were trending lower than
in the same quarters in the previous year as a result of the reduction in
R&D costs following the close of the Phase III Virulizin® clinical trials and the full
amortization of acquired R&D in August 2006.
General and administrative expenses have
remained relatively consistent across last six quarters with the exception of an
increase for the quarter ended November 30, 2006 due to severance charges
relating to the costs of
the mutual separation agreement as described in the Company’s annual
report. The three-months
ended November 30, 2007 general and administrative expenses are higher than the
previous quarters, reflecting the incurrence of annual corporate governance
costs and increased corporate communication costs over the previous
periods.
The Company recognized a gain on sale of
shares on the close of the Arrangement as discussed above in the quarter ended
August 31, 2007.
(Amounts in 000’s except for per
common share data)
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Feb. 29,
2008
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Nov. 30,
2007
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Aug. 31,
2007
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May 31,
2007
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Feb. 28,
2007
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Nov. 30,
2006
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Aug. 31,
2006
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May 31,
2006
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Revenue
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$ |
3 |
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|
$ |
1 |
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$ |
26 |
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|
$ |
40 |
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$ |
37 |
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|
$ |
23 |
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|
$ |
7 |
|
|
$ |
14 |
|
Research and
development
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|
2,222 |
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|
|
1,247 |
|
|
|
782 |
|
|
|
259 |
|
|
|
672 |
|
|
|
1,122 |
|
|
|
1,331 |
|
|
|
1,353 |
|
General and
administrative
|
|
|
863 |
|
|
|
1,103 |
|
|
|
736 |
|
|
|
820 |
|
|
|
833 |
|
|
|
1,407 |
|
|
|
788 |
|
|
|
730 |
|
Net
loss
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|
(3,850 |
) |
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|
(2,825 |
) |
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3,991 |
|
|
|
(1,689 |
) |
|
|
(2,062 |
) |
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|
(3,117 |
) |
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|
(2,770 |
) |
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|
(2,720 |
) |
Basic
and diluted net (loss) profit per
share
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|
$ |
(0.02 |
) |
|
$ |
(0.01 |
) |
|
$ |
0.02 |
|
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
used in operating activities
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|
$ |
(2,586 |
) |
|
|
(2,537 |
) |
|
$ |
(2,348 |
) |
|
$ |
(89 |
) |
|
$ |
(1,805 |
) |
|
|
(2,585 |
) |
|
$ |
(1,815 |
) |
|
$ |
(1,940 |
) |
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 GTI-2040 Phase II clinical trials is
done by the US NCI at its cost. Lorus has undertaken an expanded
GTI-2040 trial at its own cost and is in the process of acquiring additional
quantities of GTI-2040 drug to support ongoing trials. The Company is
currently in the assessment phase of results from its GTI-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 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 the Company’s
current level of cash and cash equivalents and short term investments will be
sufficient to execute the Company’s current planned expenditures for the next
twelve months; however, the debt obligation is due in October 2009 and the
Company 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.
At
February 29, 2008, Lorus
had cash and cash equivalents and short-term investments totaling $12.2 million
compared to $12.4 million at May 31, 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, cash equivalents and short term investments less
current liabilities) at February
29, 2008 was $10.9 million as compared to $6.2 million at May 31,
2007.
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.
Contractual Obligations and Off-Balance
Sheet Financing
At
February 29, 2008, we had
contractual obligations requiring annual payments as follows:
(Amounts
in 000’s)
|
|
Less
than 1 year
|
|
|
1-3
years
|
|
|
Total
|
|
Operating
leases
|
|
|
139 |
|
|
|
284 |
|
|
|
423 |
|
Convertible Debenture1
|
|
|
- |
|
|
|
15,000 |
|
|
|
15,000 |
|
Total
|
|
|
139 |
|
|
|
15,284 |
|
|
|
15,423 |
|
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 excludes interest expense which is payable
monthly by issuance of commons shares which is calculated at a rate of prime
plus 1% on the outstanding balance.
In
December 2007 the Company entered into a contract to manufacture GTI-2040 for
clinical trial purposes at an expected cost of $1.5 million of which $1.0
million has been incurred as at February 29, 2008 and the remaining $500
thousand has yet to be incurred but will become payable upon release to Lorus of
a cGMP manufactured product which we anticipate to be during the fourth quarter
of 2008.
The
Company had entered into contracts with a third party service provider to
perform GLP toxicity studies on LOR-253 the Company’s lead Small Molecule
compound. The total value of these contracts is $850 thousand of
which $400 thousand had been accrued or paid as of February 29,
2008. The remaining amounts will become due as the study milestones
are achieved. We expect that the remaining amount will be paid or
accrued during the fourth quarter of 2008.
In
addition, the Company is party to certain licensing agreements that require the
Company to pay a proportion of any fees that the Company may receive from future
revenues or milestone payments. As of February 29, 2008 no amounts are owing and
the amount of future fees is not determinable.
As at February 29, 2008, we have not entered into any off-
balance sheet arrangements.
Until one of our drug candidates
receives regulatory approval and is successfully commercialized, Lorus will
continue to incur operating losses. The magnitude of these operating
losses will be largely affected by the timing and scope of future research and
development, clinical trials and other development activities related to the
Company’s lead products, as well as any new initiatives. Finally, the
duration of the operating losses will depend on the scientific results of such
clinical trials.
Subsequent Events
On April 8, 2008 the Company announced
that its subsidiary Genesense Technologies Inc. had signed an exclusive multinational license agreement with Zor Pharmaceuticals, LLC
(“ZOR”) formed as a
subsidiary of Zoticon
Bioventures Inc. (North America and Israel), a research-driven biopharmaceutical
group whose purpose is to further develop and commercialize Virulizin®
for human therapeutic
applications. ZOR will be responsible for the cost of all the
clinical development, regulatory submissions and commercialization of
Virulizin® in North and South America, Europe and
Israel. GeneSense will retain rights in rest of the
world. The license agreement will continue until the date of the
expiration of the last to expire royalty term (last to expire of the valid
claims of the licensor’s patent rights) in any country.
Under the terms of the agreement,
GeneSense will be entitled to receive 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.
Immediately prior to executing the
license agreement, Lorus (through its newly formed subsidiary Pharma Immune
Inc.) received 25% of the equity in ZOR in exchange for a capital contribution
of $2,500. This investment will be treated as an equity
investment. Lorus’ equity will not be subject to dilution on the
first US$5 million of financing in ZOR. Thereafter, Lorus has,
at its option, a right to participate in any additional financings to maintain
its ownership level. The Company has also entered into a service
agreement with ZOR to assist in the transfer of knowledge and establish a strong
foundation for moving forward with the development program. Under
this agreement GeneSense has agreed to provide ZOR with 120 hours of consulting
service at its own expense and thereafter will provide services at an agreed
upon rate. The service contract will last for one year unless stated otherwise in any project
assignment that extends beyond one year but no longer than the date of
termination of the License Agreement for any reason.
This transaction will be accounted for
in the fourth quarter of fiscal 2008.
RISK FACTORS
Before
making an investment decision with respect to our common shares, you should
carefully consider the following risk factors, in addition to the other
information included or incorporated by reference into this report. The risks
set out below are not the only risks we face. If any of the following risks
occur, our business, financial condition, prospects or results of operations
would likely suffer. In that case, the trading price of our common shares could
decline and you may lose all or part of the money you paid to buy our common
shares.
Please
refer to the MD&A included in our 2007 Annual Report for a complete
discussion of risks and uncertainties.
|
•
|
We
have a history of operating losses. We expect to incur net losses and we
may never achieve or maintain
profitability.
|
|
•
|
The
cash and cash equivalents on hand is not sufficient to repay the
debentures at maturity.
|
|
•
|
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.
|
|
•
|
We
may be unable to obtain partnerships for one or more of our product
candidates which could curtail future development and negatively impact
our share price.
|
|
•
|
Clinical
trials are long, expensive and uncertain processes and Health Canada or
the FDA may ultimately not approve any of our product candidates. We may
never develop any commercial drugs or other products that generate
revenues.
|
|
•
|
As
a result of intense competition and technological change in the
pharmaceutical industry, the marketplace may not accept our products or
product candidates, and we may not be able to compete successfully against
other companies in our industry and achieve
profitability.
|
|
•
|
We
may be unable to obtain patents to protect our technologies from other
companies with competitive products, and patents of other companies could
prevent us from manufacturing, developing or marketing our
products.
|
|
•
|
Our
products and product candidates may infringe the intellectual property
rights of others, which could increase our
costs.
|
|
•
|
Our
share price has been and may continue to be volatile and an investment in
our common shares could suffer a decline in
value.
|
|
•
|
Future
sales of our common shares by us or by our existing shareholders could
cause our share price to fall.
|
|
•
|
Conversion
of our secured convertible debentures will dilute the ownership interest
of existing shareholders.
|
CRITICAL ACCOUNTING
POLICIES
Critical Accounting Policies and
Estimates
Our accounting policies are in
accordance with Canadian GAAP including some that require management to make
assumptions and estimates that could significantly affect the results of
operations and financial position. The significant accounting
policies that we believe are the most critical in fully understanding and
evaluating the reported financial results are disclosed in the MD&A section
of our 2007 annual report. As well, our significant accounting
policies are disclosed in Note 2, Significant
Accounting Policies, of the
notes to the financial statements of Old Lorus (subsequently renamed 4325231
Canada Inc.) provided as Supplemental Financial Information in our annual report
for the fiscal year ended May 31, 2007.
Recently Adopted Accounting
Recommendations
Effective on June 1, 2007, the Company
adopted the recommendations of CICA Handbook Section 1530, Comprehensive Income
("Section 1530"); Section 3855, Financial Instruments - Recognition and Measurement ("Section
3855); 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.
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 fixed
income government investments and corporate instruments 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 while held-for-trading investments are measured at
fair value and the resulting gain or loss is recognized in the consolidated
statement of loss and deficit. As a result of adopting the new
standards, the Company designated certain corporate instruments previously
carried at amortized cost as held-for-trading investments. This
change in accounting policy resulted in an increase in the opening deficit
accumulated during the development stage by $27 thousand and a net gain in the
consolidated statement of loss and deficit for the nine-month period ended
February 29, 2008 of $4 thousand.
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 as the escrowed amount is released in July 2008.
Recent Accounting Recommendations not
yet adopted
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 statement.
The CICA plans to converge Canadian GAAP
with International Financial Reporting Standards (IFRS) over a transition period
expected to end in 2011. The impact of the transition to IFRS on
the Company’s financial statements has not been determined.
Section
3064, “Goodwill and intangible assets”, will be replacing Section 3062,
“Goodwill and other intangible assets” and Section 3450,
“Research and development costs”. This new section, issued in February 2008,
will be applicable to financial statements relating to fiscal years beginning on
or after October 1, 2008. Accordingly, the Company will adopt the new standards
for its fiscal year beginning June 1, 2009. It establishes standards for the
recognition, measurement, presentation and disclosure of goodwill subsequent to
its initial recognition and of intangible assets by profit-oriented enterprises.
Standards concerning goodwill are unchanged from the standards included in the
previous Section 3062. The impact
of adoption of this new section on the Company’s financial statements has not
been determined.
DISCLOSURE CONTROLS AND
PROCEDURES
The
Chief Executive Officer (“CEO”) and the Chief Financial Officer (“CFO”), after
evaluating the effectiveness of the Company’s "disclosure controls and
procedures" (as defined in Multilateral Instrument 52-109-Certification of
Disclosure in Issuer's Annual and Interim Filings) as of May 31, 2007 (the
"Evaluation Date") have concluded that as of the Evaluation Date, our disclosure
controls were effective to provide reasonable assurance that information
required to be disclosed in our reports filed or submitted under Canadian
securities laws is recorded, processed, summarized and reported within the time
periods specified by those rules, and that material information relating to our
Company and any consolidated subsidiaries is made known to management, including
the CEO and CFO, particularly during the period when our periodic reports are
being prepared to allow timely decisions regarding required
disclosure.
Peter
Korth stepped down from his position as
CFO, effective April
14, 2008. Elizabeth Williams, CA,
Lorus’ Director of Finance and Controller for the past four years, assumed his
financial duties as Acting CFO. Elizabeth Williams has held the Acting CFO
position at Lorus in the past, from November 2005 to January 2008. We
do not expect this change to have any impact on our disclosure controls and
procedures.
UPDATED SHARE
INFORMATION
As at April 14, 2008, the Company had
216,716,000 common shares issued and outstanding. In addition, the
Company had issued and outstanding 17,188,000 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' 2007 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).