Exhibit
99.2
MANAGEMENT’S
DISCUSSION AND ANALYSIS
The
following information prepared as at April 16, 2007 should be read in
conjunction with the unaudited consolidated financial statements and notes
prepared in accordance with Canadian generally accepted accounting principles
(GAAP) in this quarterly report and should also be read in conjunction with
the
audited consolidated financial statements and notes and management’s discussion
and analysis contained in the Company’s annual report for the year ended May 31,
2006. All amounts are expressed in Canadian dollars unless otherwise
noted.
Overview
of the Business
Lorus
is a Canadian biotechnology company, traded on both the TSX (LOR) and AMEX
(LRP), focused on the discovery, research and development of well-tolerated
therapies that manage cancer and promote an improved quality of life. We are
currently operating several research and pre-clinical programs in-house and
have
two products in clinical development with a Phase II clinical trial program
underway. We continue to focus on partnership activities for all of our drug
candidates.
The
lead drug in our antisense portfolio, GTI-2040 continues to advance in the
clinic. There are currently six clinical trials with GTI-2040 sponsored by
the
US National Cancer Institute (NCI) in six different indications underway..
We
announced during the first quarter that an additional trial, to be sponsored
by
the US NCI, using GTI-2040 for the treatment of myelodysplastic syndrome would
be initiated during the third quarter. The Company received approval for patient
recruitment under this program in early fourth quarter. We have continued the
development of our small molecule program by advancing our lead molecule, LT-253
into toxicity studies. We anticipate that upon successful results of these
toxicity studies that we will be in the position to initiate a Phase I clinical
trial.
In
addition, Lorus has other novel, proprietary drug candidates in its product
development pipeline including siRNA, other low molecular weight compounds
and
tumor suppressor/gene therapy approach. We have recently announced our lead
siRNA drug, siRNA-1284 has demonstrated potent antitumor activity in
pre-clinical studies.
Results
of Operations
Cash
used in Operating Activities
Cash
used in operating activities was $1.8 million for the three-month period ended
February 28, 2007 compared to $4.0 million in the same period last year. For
the
nine-month period ended February 28, 2007 cash used in operating activities
totaled $6.2 million compared with $11.1 million for the nine months ended
February 28, 2006. The decrease in cash used in operating activities during
the
current three and nine month period ended is due to lower research and
development and general and administrative expenditures in comparison with
the
same periods last year.
Research
and Development
Research
and development expenses for the three-month period ended February 28, 2007
decreased 70.7% to $672 thousand compared to $2.3 million for the same period
last year. For the nine-month period ended February 28, 2007, research and
development expenses decreased 64.8% to $3.1 million compared to $8.9 million
for the same period last year. The decrease in research and development costs
is
primarily due to a reduction in toxicity study, clinical trial, compliance,
manufacturing and regulatory costs associated with the Phase III
Virulizin®
development program which was ongoing during the nine-month period ended
February 28, 2006, which was subsequently completed. In addition, due to
headcount reductions implemented over the previous year, we have fewer employees
engaged in research and development activities. The ongoing research and
development costs relate to the GTI-2040 and GTI-2501 clinical development
programs ongoing as well as our small molecule pre-clinical
program.
General
and Administrative
General
and administrative expenses for the three-month period ended February 28, 2007
decreased to $833 thousand compared with $909 thousand in the same period last
year. General and administrative expenses for the nine-month period ended
February 28, 2007 decreased to $3.0 million compared with $3.6 million in the
same period last year. The decrease in general and administrative costs is
the
result of continued staff reductions, and a continued focus on lowering costs
in
all areas of the business. The cost savings realized during the current nine
month period is partially offset by charges incurred under the mutual separation
agreement entered into with Dr. Jim Wright discussed under “Corporate Changes”
below.
Stock-Based
Compensation
Stock-based
compensation expense decreased to $105 thousand for the three-month period
ended
February 28, 2007 compared with $400 thousand for the same period last year
and
was $368 thousand for the nine-month period ended February 28, 2007 compared
with $1.1 million for the nine-month period ended February 28, 2006. The
decrease in stock-based compensation expense is attributable to fewer options
issued due to fewer employees and executive officers, a lower fair value
assigned to the options issued resulting from a lower stock price, as well
as
the reversal of stock option expense previously recorded of $382 thousand for
the nine months ended February 28, 2007 ($183 thousand for the same period
last
year) due to the forfeiture of unvested options upon non-achievement of certain
objectives.
Interest
and Accretion Expense
We
recognized non-cash interest expense of $259 thousand for the three-month
period ended
February 28, 2007 compared with $224 thousand in the same period last year
and
$786 thousand for the nine-month period ended February 28, 2007 compared with
$631 thousand in the same period last year representing interest at a rate
of
prime +1% on our $15.0 million convertible debentures (the ‘debentures’). The
increase in interest expense over the prior periods is the result of increases
in the prime rate of interest in comparison with the prior periods. The interest
accrued on the debenture during the three and nine-month periods ended February
28, 2007 was paid in common shares of the Company, a non-cash
expense.
Accretion
in the carrying value of the convertible debenture amounted to $236 thousand
for
the three-month
period ended February 28, 2007 compared with $202 thousand in the same period
last year and $682 thousand for the nine-month period ended
February 28, 2007 compared with $568 thousand for the six months ended February
28, 2006. The accretion charges arise as under Canadian GAAP, the Company has
allocated the proceeds from each tranche of the convertible debenture to the
debt and equity instruments issued on a relative fair value basis resulting
in
the $15.0 million convertible debentures having an initial cumulative carrying
value of $9.8 million as of their dates of issuance. The carrying value of
the
convertible debt is accreted to its maturity amount.
Depreciation
and Amortization
Depreciation
and amortization expense for the three-month and nine-month periods ended
February 28, 2007 was $98 thousand and $298 thousand, respectively, compared
to
$130 thousand and
$390 thousand for the same periods in the prior year. The decrease in
depreciation and amortization expense is the result of reduced capital asset
purchases during fiscal 2006 and 2007.
Amortization
of Deferred Financing Charges
Amortization
of deferred financing charges for the three-month and nine-month periods ended
February 28, 2007 were $27 thousand and $79 thousand, respectively, compared
to
$23 thousand and $62 thousand for the same periods in the prior year.
During
the quarter, the Company incurred approximately $530 thousand in deferred
arrangement costs associated with negotiating a possible financing arrangement.
These negotiations are ongoing but have not yet resulted in a definitive
agreement. Management expects that it will complete these negotiations in the
near term and will provide details once an agreement is reached or a statement
that negotiations have terminated. These deferred costs and any additional
costs
would be netted against proceeds from the arrangement if completed or expensed
if not completed.
Interest
Income
Interest
income for the three-month period ended February 28, 2007 was $137 thousand,
compared with $85 thousand for the same period last year. The increase in the
current year is attributable to a higher average cash and short-term investment
balance during the period as well as higher interest rates. For the nine-month
period ended February 28, 2007, interest income was $362 thousand compared
to
$295 thousand for the same period last year. The increase is attributable to
higher interest rates and higher marketable security balance during the year
primarily as a result of financing proceeds discussed below having been received
in August 2006.
Net
Loss
Net
loss for the three-month period ended February 28, 2007 totaled $2.1 million
($0.01 per share) compared to a loss of $4.1 million ($0.02 per share) for
the
same period last year. For the nine-month period ended February 28, 2007, net
loss totaled $7.9 million ($0.04 per share) compared to $14.9 million ($0.09
per
share) for the comparable period last year. The decrease in net loss for the
three months ended February 2, 2007 is primarily the result of reductions in
research and development expenses of $1.6 million, general and administrative
expenses of $76 thousand and stock based compensation expense of $295 thousand.
The year to date decrease in net loss is due largely to a reduction of $5.7
million in research and development expenses, lower general and administrative
expenses of $576 thousand and lower stock based compensation expense of $737
thousand.
Financing
On
August 30, 2006, Lorus raised gross proceeds of $10.4 million by way of a
subscription agreement for 28.8 million common shares at a price of $0.36 per
common share. The 28.8 million common shares have been qualified for
distribution in Canada under a short form prospectus filed on August 25, 2006
with the Ontario Securities Commission. In addition to the qualification
prospectus filed in August, the investor received demand registration rights
that will enable the investor to request Lorus to file a
Canadian
prospectus or a registration statement under the United States Securities Act
(Registration Documents) to register the resale of all or part of the common
shares held by the Investor, subject to certain restrictions. Lorus is required
to file a maximum of five Registration Documents at the investor’s request.
These demand registration rights will expire on June 30, 2012.
On
August 31, 2006, Lorus raised gross proceeds of $1.8 million by way of a private
placement for 5.0 million common shares at a price of $0.36 per common
share.
We
incurred expenses of $527 thousand related to these issuances, which have been
recorded as a reduction to share capital.
During
the quarter ended August 31, 2006, 46 thousand stock options were exercised
for
cash proceeds of $14 thousand (August 31, 2005 - nil). There were no stock
options exercised during the three-month period ended February 28, 2007 or
2006.
Corporate
Changes
Dr.
Jim
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 three months ended May 31, 2006 of $500 thousand and charged
general and administrative expense. Amounts payable under the mutual separation
agreement were paid during the third quarter.
Quarterly
Financial Information (unaudited)
|
(in
thousands of dollars, except per share
amounts)
|
(Amounts
in 000’s except for per common share data)
|
|
|
Feb
28,
2007
|
|
|
Nov.
30, 2006
|
|
|
Aug.
31, 2006
|
|
|
May
31, 2006
|
|
|
Feb.
28, 2006
|
|
|
Nov.
30, 2005
|
|
|
Aug.
31, 2005
|
|
|
May
31, 2005
|
|
Revenue
|
|
$
|
37
|
|
$
|
23
|
|
$
|
7
|
|
$
|
14
|
|
$
|
5
|
|
$
|
6
|
|
$
|
1
|
|
$
|
-
|
|
Research
and development
|
|
|
672
|
|
|
1,122
|
|
|
1,331
|
|
|
1,353
|
|
|
2,296
|
|
|
2,631
|
|
|
3,957
|
|
|
2,332
|
|
General
and administrative
|
|
|
833
|
|
|
1,407
|
|
|
788
|
|
|
730
|
|
|
909
|
|
|
1,619
|
|
|
1,076
|
|
|
1,506
|
|
Net
loss
|
|
|
(2,062
|
)
|
|
(3,117
|
)
|
|
(2,770
|
)
|
|
(2,920
|
)
|
|
(4,095
|
)
|
|
(5,102
|
)
|
|
(5,742
|
)
|
|
(4,598
|
)
|
Basic
and diluted net
loss per
share
|
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.01
|
)
|
$
|
(0.02
|
)
|
$
|
(0.02
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
$
|
(0.03
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
used in operating activities
|
|
|
(1,805
|
)
|
|
(2,585
|
)
|
$
|
(1,814
|
)
|
$
|
(1,940
|
)
|
$
|
(3,956
|
)
|
$
|
(2,360
|
)
|
$
|
(4,809
|
)
|
$
|
(3,789
|
)
|
Liquidity
and Capital Resources
Since
its inception, Lorus has financed its operations and technology acquisitions
primarily from equity and debt financing, the exercise of warrants and stock
options, and interest income on funds held for future investment. We expect
to
continue to finance the development of our small molecule program from internal
resources until their anticipated completion. The ongoing costs of the GTI-2040
Phase II clinical program will continue to be borne by the US NCI with Lorus
continuing to be responsible for any additional GTI-2040 manufacturing costs.
We
currently have a sufficient supply of GTI-2040 on hand to complete the clinical
trials underway.
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
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.
Our
current level of cash and short-term investments are sufficient to execute
our
current planned expenditures for the next twelve months.
Cash
Position
At
February 28, 2007 Lorus had cash and cash equivalents and short-term investments
totaling $8.5 million compared to $8.3 million at May 31, 2006. Working capital
was $7.1 million at February 28, 2007 compared to $5.8 million at May 31, 2006.
In
addition to its cash and short-term investments, the Company has available
$4.8
million in long-term Marketable Securities, compared to none at May 31, 2006.
In
addition to the above, the Company expects to realize approximately $8.0 million
in the fourth quarter as a result of the corporate reorganization outlined
above
Contractual
Obligations and Off-Balance Sheet Financing
At
February 28, 2007, 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 |
|
|
139 |
|
|
56 |
|
|
— |
|
|
—
|
|
|
195
|
|
Convertible
Debenture1 |
|
|
— |
|
|
— |
|
|
15,000 |
|
|
—
|
|
|
15,000 |
|
Total
|
|
|
139 |
|
|
56 |
|
|
15,000 |
|
|
— |
|
|
15,195 |
|
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.
Outlook
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.
Risks
and Uncertainties
Please
refer to the MD&A included in our 2006 Annual Report for a complete
discussion of risks and uncertainties.
Some
of
the most immediate risks and uncertainties facing us in the next fiscal year
include:
§ |
We
have a history of operating losses. We expect to incur additional
losses
and we may never achieve or maintain
profitability.
|
§ |
We
will need to raise additional funds to conduct research and development,
preclinical studies, and clinical trials necessary to bring our potential
products to market. We intend to raise additional financing, as required,
through strategic alliance arrangements, the exercise of options
and
warrants, and the issuance of new share capital, as well as through
other
financing opportunities. There can be no assurance that these financing
efforts will be successful or that we will continue to be able to
meet our
ongoing cash requirements.
|
§ |
Risk
that that arrangement agreement entered into subsequent to the quarter-end
does not get shareholder approval or close as
anticipated.
|
§ |
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.
|
§ |
We
may never develop any commercial drugs or other products that generate
revenues.
|
§ |
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.
|
§ |
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
cash flow may not be sufficient to cover interest payments on the
secured
convertible debentures or to repay the debentures upon maturity or
in the
event of default.
|
§ |
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.
|
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 2006 Annual Report. As well, our significant accounting policies
are disclosed in Note 2, Significant
Accounting Policies, of
the
notes to our audited consolidated financial statements for the fiscal year
ended
May 31, 2006.
Recent
Accounting Pronouncements
In
January 2005, the CICA released new Handbook Section 1530, Comprehensive Income,
and Section 3251, Equity. Section 1530 establishes standards for reporting
comprehensive income. The section does not address issues of recognition or
measurement for comprehensive income and its components. Section 3251
establishes standards for the presentation of equity and changes in equity
during the reporting period. The requirements in this section are in addition
to
Section 1530.
Section
3855, Financial Instruments—Recognition and Measurement
CICA
Handbook Section 3855 establishes standards for the recognition and measurement
of all financial instruments, provides a characteristics-based definition of
a
derivative instrument, provides criteria to be used to determine when a
financial instrument should be recognized, and provides criteria to be used
to
determine when a financial liability is considered to be
extinguished.
Section
3865, Hedges
CICA
Handbook Section 3865 establishes standards for when and how hedge accounting
may be applied. Hedge accounting is optional.
These
three sections are effective for the fiscal years beginning on or after October
1, 2006. An entity adopting these Sections for a fiscal year beginning before
October 1, 2006 must adopt all the Sections simultaneously.
Disclosure
Controls
Lorus
announced during the second quarter that Dr. Jim Wright
would
be resigning as the Company’s
President and CEO
effective September 21, 2006. Lorus also announced that
Dr.
Aiping Young, the Company's COO, would be appointed President and CEO effective
the same day
as Dr.
Jim Wright’s resignation.
As
Lorus was not without a President and CEO for any period of time,
and
given Dr. Aiping Young's knowledge of the Company and its internal and
disclosure controls, we do not believe that
our
current internal and disclosure control structure
has
been compromised from this change in management.
Updated
Share Information
As
at
April 13, 2007, the number of issued and outstanding common shares of the
Company was 211,610,130. In addition, there were 3,000,000 warrants to purchase
3,000,000 common shares of the Company and 13,557,000 stock options outstanding
can be exercised into an equal number of common shares. The convertible
debentures are convertible into 15,000,000 common shares of the Company at
the
option of the holder.
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: our expectations regarding future
financings, our plans to conduct clinical trials, the successful and timely
completion of clinical studies and the regulatory approval process, our plans
to
obtain partners to assist in the further development of our product candidates,
the establishment of corporate alliances, the Company’s plans, objectives,
expectations and intentions and other statements including words such as
“continue”, “believe”, “plan”, “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:
· |
our
ability to obtain the capital required for research and
operations
|
· |
the
regulatory approval process;
|
· |
the
progress of our clinical trials;
|
· |
our
ability to find and enter into agreements with potential
partners;
|
· |
our
ability to attract and retain key
personnel;
|
· |
changing
market conditions; and
|
· |
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
|
Should
one or more of these risks or uncertainties materialize, or should the
assumptions set out in the section entitled “Risk Factors” in our Annual Report
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 press release 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.