Isotechnika Pharma reports third quarter 2009 financial results
Operating highlights
- The results of the international uveitis Phase 2/3 clinical trials
studying voclosporin, conducted by the Company's partner Lux
Biosciences ("Lux"), were the subject of two podium presentations at
the American Association of Ophthalmology (AAO) meeting and of a
presentation at the satellite meeting of the American Uveitis Society
(AUS) held in San Francisco during the week of October 24-27, 2009.
The presentations highlighted the ability of voclosporin (LX211,
LUVENIQ(TM)) to control the inflammation that characterizes this
potentially blinding eye disease and significantly reduce its rate of
recurrence.
- Lux plans to file a New Drug Application (NDA) and a Marketing
Authorization Application (MAA) around year-end 2009 and early 2010
in the United States and Europe, respectively, making it possible for
voclosporin to become the first approved oral treatment capable of
modifying the course of uveitis, a group of serious eye conditions
frequently associated with either severe vision loss or substantial
morbidity from steroid use.
- Regulatory approvals in the United States and Europe will trigger
milestone payments of $7.1 million USD and $3.5 million USD,
respectively, to the Company.
- The Company has developed a portfolio of non-immunosuppressive
cyclosporine analogue molecules (NICAMs) with potent cyclophilin
inhibition but no binding to calcineurin. Cyclophilin inhibition has
garnered considerable attention as a novel therapy in the treatment
of a wide range of diseases including hepatitis C, stroke, and
chronic neurological disorders such as Parkinson's, Lou Gehrig's, and
Alzheimer's. Cyclosporine A is a well established cyclophilin
inhibitor, however, its additional strong binding to calcineurin
results in powerful immunosuppression and limits its therapeutic
potential to transplantation and various autoimmune disorders.
- The Company has appointed Dr. Jurgen Engel to its Board of Directors.
Dr. Engel is currently the President and CEO of Aeterna Zentaris,
where he has been since the acquisition of Zentaris in December 2002.
A seasoned professional in the pharmaceutical industry, he brings
extensive expertise in drug development and commercialization.
"During the third quarter, the Company continued to take the necessary steps to advance its lead product voclosporin," stated
Financial Results
The Company reported a consolidated net loss of
The Company's financial and operational resources in the third quarter ended
Revenue decreased to
Research and development expenditures were
The decrease in research and development expenditures was primarily due to reduced clinical trial costs for both the voclosporin Phase 2b renal transplant and the Phase 3 European/Canadian psoriasis trials. Both of these trials were in the final stages of completion in 2009. The Company's financial position also limited further research and development activities such as Phase 3 kidney transplant trials.
Corporate, administration and marketing costs decreased to
At
For further discussion of the Company's financial results for the three months ended
About Isotechnika Pharma
------------------------
Edmonton-based Isotechnika Pharma Inc. is a biopharmaceutical company focused on the discovery and development of novel immunosuppressive therapeutics that are designed to offer advantages over other currently available treatments. There is a significant unmet medical need in the treatment of both solid organ transplantation and autoimmune disease. It is estimated that the market potential will exceed
Voclosporin, Isotechnika's lead drug candidate, is a next generation calcineurin inhibitor. It has completed a Phase 2b study for the prevention of kidney rejection following transplantation and a Phase 3 European/Canadian trial for the treatment of moderate to severe psoriasis. Through our partner, Lux Biosciences, voclosporin is the subject of a New Drug Application (NDA) in the
Isotechnika Pharma Inc. is a publicly traded company on the
Forward-Looking Statements
--------------------------
Except for historical information, this News Release contains forward-looking statements which may not be based on historical fact. These statements may include, without limitation, plans to fund the Company's operations, statements concerning strategic alternatives, including partnering activities. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the Company's belief as to the potential of its products, its ability to protect its intellectual property rights, securing and maintaining corporate alliances and partnerships, the need for additional capital and the effect of capital market conditions and other factors on capital availability, the ability to economically manufacture its products, the potential of its products, the success and timely completion of clinical studies and trials, and the Company's and its partners' ability to successfully obtain regulatory approvals and commercialize voclosporin. Investors should consult the Company's quarterly and annual filings with the Canadian commissions for additional information on risks and uncertainties relating to the forward-looking statements These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements are made as of the date hereof, and the Company disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Isotechnika Pharma Inc.
Consolidated Interim Balance Sheets
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(expressed in thousands of Canadian dollars)
September 30 December 31
2009 2008
(Unaudited)
$ $
Assets
Current assets
Cash and cash equivalents 6,251 25,701
Accounts receivable 546 495
Inventories - 146
Prepaid expenses 189 124
--------------------------
6,986 26,466
Property and equipment 2,294 3,206
Intellectual property rights 2,275 2,771
--------------------------
11,555 32,443
--------------------------
--------------------------
Liabilities
Current liabilities
Accounts payable and accrued liabilities 1,807 3,984
Current portion of deferred revenue 1,675 1,330
Current portion of long-term debt - 5,781
Current portion of deferred lease inducements 16 16
--------------------------
3,498 11,111
Deferred revenue 1,517 1,801
Long-term debt - 9,895
Deferred lease inducements 45 58
--------------------------
5,060 22,865
--------------------------
Shareholders' Equity
Share capital
Common stock
Authorized
Unlimited number of common shares without
par value
Issued and outstanding
131,314,804 shares (December 31, 2008 -
106,243,492) 195,948 192,706
Warrants 171 3,293
Contributed surplus 8,792 5,593
Deficit (198,416) (192,014)
--------------------------
6,495 9,578
--------------------------
11,555 32,443
--------------------------
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Isotechnika Pharma Inc.
Consolidated Interim Statements of Operations and Comprehensive Loss
(Unaudited)
-------------------------------------------------------------------------
(expressed in thousands of Canadian dollars)
Three Months Ended Nine Months Ended
September 30 September 30 September 30 September 30
2009 2008 2009 2008
$ $ $ $
Revenue
Licensing revenue 408 271 689 271
Research and
development
revenues 237 - 237 -
Diagnostic royalty
income 219 - 262 -
Contract services
and product sales 162 2,590 1,373 3,734
-------------------------------------------------------
1,026 2,861 2,561 4,005
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Expenses
Research and
development 1,839 3,117 5,870 10,956
Refundable tax
credits - - (117) -
-------------------------------------------------------
1,839 3,117 5,753 10,956
Corporate,
administration and
marketing 675 1,160 3,075 4,227
Cost of contract
services and product
sales 48 1,912 574 2,404
Amortization of
property and
equipment 221 278 714 900
Interest and
prepayment costs
on long-term debt - 332 1,077 392
Amortization and
write down of
intellectual
property 111 48 322 130
Loss (Gain) on
disposal of
equipment 1 - (44) (5)
-------------------------------------------------------
2,895 6,847 11,471 19,004
-------------------------------------------------------
Loss before the
undernoted (1,869) (3,986) (8,910) (14,999)
-------------------------------------------------------
Other income
(expense)
Investment income 2 180 36 597
Foreign exchange
gain (loss) 66 89 127 (83)
Net gain from plan
of arrangement - - 2,345 -
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68 269 2,508 514
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Net loss for the
period (1,801) (3,717) (6,402) (14,485)
Other comprehensive
income - - - -
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Comprehensive loss
for the period (1,801) (3,717) (6,402) (14,485)
-------------------------------------------------------
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Basic and diluted
loss per share (0.01) (0.04) (0.06) (0.14)
-------------------------------------------------------
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%SEDAR: 00028600E
For further information: Dr. Robert Foster, President & CEO, Isotechnika Pharma Inc., (780) 487-1600 (247), (780) 484-4105 (fax), [email protected]; Mr. Dennis Bourgeault, Chief Financial Officer, Isotechnika Pharma Inc., (780) 487-1600 (226), (780) 484-4105 (fax), [email protected]
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