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Isotechnika Pharma reports second quarter 2009 financial results

^{Published on 2009-08-06 06:38:56, Last Modified on 2009-08-06 06:39:03 - Market Wire}
 

 EDMONTON, Aug. 6 /CNW/ - Isotechnika Pharma Inc. (TSX:ISA) today announced its financial results for the second quarter ended June 30, 2009. The highlights of the second quarter included: - The completion of the Plan of Arrangement with Paladin Labs Inc. ("Paladin"), a leading Canadian specialty pharmaceutical company, which creates a strategic partnership for the future commercialization of voclosporin in Canada, Mexico, Central and South America, Israel and South Africa. This arrangement provided Isotechnika Pharma with gross proceeds of $7 million upon completion and $4.35 million in supported R&D funding over the next 12 months. - Mr. Jonathan Ross Goodman, founder, President & CEO of Paladin, assumed the position as Chairman of the Board of Directors. Additionally, Ms. Nancy Harrison, co-founder of MSI Methylation Sciences Inc. and former Senior Vice President of Ventures West Management Inc., joined as a new Board member. Ms. Mary Ritchie and Mssrs. Douglas Walker and Donald Schurman resigned from the Board. - The release of positive data from both the Phase 2b PROMISE trial evaluating voclosporin in de novo kidney transplant patients after 12 months of treatment and the Phase 3 ESSENCE trial evaluating voclosporin in moderate to severe psoriasis patients. "During the second quarter, the Company continued to take the necessary steps to focus its resources and reduce the burn rate," stated Dr. Robert Foster, President & CEO of Isotechnika. "We are actively seeking additional partners for voclosporin and evaluating opportunities to acquire new technologies for Isotechnika Pharma." Financial Results At June 30, 2009, the Company has $7.3 million in cash and cash equivalents. The Company reported a consolidated net loss of $472,000 or $nil per common share for the three months ended June 30, 2009, as compared to a consolidated net loss of $5.4 million or $0.05 per common share for the same period in 2008. For the six months ended June 30, 2009, the consolidated net loss was $4.6 million or $0.04 per common share compared to $10.8 million or $0.10 per common share for the comparable period in 2008. The consolidated net loss decreased due to the Company having lower clinical trial expenses and recording a gain of $2.3 million on the asset sale pursuant to the Arrangement with Paladin. Revenue increased slightly to $718,000 for the second quarter ended June 30, 2009, compared to $565,000 for the second quarter ended June 30, 2008. The Company recorded revenue of $1.5 million for the six months ended June 30, 2009, as compared to $1.1 million for the same period in 2008. Research and development expenditures were $1.5 million in the second quarter of 2009, compared to $3.9 million in the second quarter of 2008, a decrease of $2.4 million. The Company incurred total research and development expenditures of $4.0 million for the six months ended June 30, 2009, as compared to $7.8 for the same period in 2008. 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 research and development activities. Corporate, administration and marketing costs decreased to $1.4 million for the second quarter of 2009, compared to $1.6 million for the second quarter of 2008. Isotechnika incurred a total corporate, administration and marketing expenditure of $2.4 million for the six months ended June 30, 2009, as compared with $3.1 million for the same period in fiscal 2008. For further discussion of the Company's financial results for the three months ended June 30, 2009, the unaudited interim consolidated financial statements and the Management's Discussion and Analysis are accessible on Isotechnika's Web site at [ www.isotechnika.com ] or at [ www.sedar.com ]. About Isotechnika ----------------- 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 $4 billion annually in sales for calcineurin inhibitors such as voclosporin by 2010. Voclosporin is a next generation calcineurin inhibitor, which completed a Phase 2b North American trial for the prevention of kidney rejection following transplantation. Extensions to the Phase 2b trial and a combined Phase 3 European/Canadian trial for the treatment of moderate to severe psoriasis have also been completed. Our partner, Lux BioSciences, Inc., has also completed three separate Phase 2/3 pivotal trials investigating voclosporin (referred to as LUVENIQTM by Lux) for the treatment of uveitis. In addition to the uveitis trials, Lux BioSciences Inc. has also commenced a Phase 1 trial using their proprietary voclosporin ophthalmic solution (LX214) as a candidate for dry eye syndrome. Voclosporin has also entered First-in-Man trials as the drug utilized in the CINATRA(TM) Drug Coated Coronary Stent system developed by the Company's partner, Atrium Medical Corporation. Isotechnika Pharma Inc. is a publicly traded company on the Toronto Stock Exchange under the symbol "ISA". More information on Isotechnika Pharma can be found at [ www.isotechnika.com ] or [ www.SEDAR.com ]. Forward-Looking Statements -------------------------- This press release may contain forward-looking statements. Forward looking statements, including the Company's belief as to the potential of its products, the Company's expectations regarding the issuance of additional patents and the Company's ability to protect its intellectual property, involve known and unknown risks and uncertainties, which could cause the Company's actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the ability to economically manufacture its products, the potential of its products, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize its products, the ability of the Company to defend its intellectual property rights from infringement by third parties, and the risk that the Company's intellectual property rights may be subsequently shown to be invalid or infringe the patents of others. 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. Investors are cautioned against placing undue reliance on forward-looking statements. Isotechnika Pharma Inc. Consolidated Interim Balance Sheets ------------------------------------------------------------------------- (expressed in thousands of Canadian dollars) June 30 December 31 2009 2008 (Unaudited) $ $ Assets Current assets Cash and cash equivalents 7,330 25,701 Accounts receivable 121 495 Inventories - 146 Prepaid expenses 102 124 ------------------------ 7,553 26,466 Property and equipment 2,506 3,206 Intellectual property rights 2,291 2,771 ------------------------ 12,350 32,443 ------------------------ ------------------------ Liabilities Current liabilities Accounts payable and accrued liabilities 852 3,984 Current portion of deferred revenue 2,094 1,330 Current portion of long-term debt - 5,781 Current portion of deferred lease inducements 16 16 ------------------------ 2,962 11,111 Deferred revenue 1,085 1,801 Long-term debt - 9,895 Deferred lease inducements 50 58 ------------------------ 4,097 22,865 ------------------------ Shareholders' Equity Share capital Common stock Authorized Unlimited number of common shares without par value Issued and outstanding 131,214,804 shares (December 31, 2008 - 106,243,492) 195,929 192,706 Warrants 171 3,293 Contributed surplus 8,768 5,593 Deficit (196,615) (192,014) ------------------------ 8,253 9,578 ------------------------ 12,350 32,443 ------------------------ ------------------------ Isotechnika Pharma Inc. Consolidated Interim Statements of Operations and Comprehensive Loss (Unaudited) ------------------------------------------------------------------------- (expressed in thousands of Canadian dollars) Three Months Ended Six Months Ended June 30 June 30 June 30 June 30 2009 2008 2009 2008 $ $ $ $ Revenue Product sales and contract services 573 565 1,211 1,144 Licensing revenue 102 - 281 - Diagnostic royalty income 43 - 43 - ------------------------------------------------ 718 565 1,535 1,144 ------------------------------------------------ Expenses Research and development 1,611 4,021 4,031 7,839 Refundable tax credits (117) - (117) - 1,494 4,021 3,914 7,839 Corporate, administration and marketing 1,356 1,583 2,400 3,067 Cost of product sales and contract services 275 231 526 492 Amortization of property and equipment 244 294 493 622 Interest and prepayment on long-term debt 225 52 1,077 60 Amortization and write-down of patent costs 33 56 211 82 Loss (Gain) on disposal of equipment 10 (2) (45) (5) ------------------------------------------------ 3,637 6,235 8,576 12,157 ------------------------------------------------ Loss before the undernoted (2,919) (5,670) (7,041) (11,013) ------------------------------------------------ Other income (expense) Investment income 9 157 34 417 Foreign exchange translation gain (loss) 93 82 61 (172) Net gain from plan of arrangement 2,345 - 2,345 - ------------------------------------------------ 2,447 239 2,440 245 ------------------------------------------------ Net loss for the period (472) (5,431) (4,601) (10,768) Other comprehensive income (loss) - - - - ------------------------------------------------ Comprehensive loss for the period (472) (5,431) (4,601) (10,768) ------------------------------------------------ ------------------------------------------------ Basic and diluted loss per share - (0.05) (0.04) (0.10) ------------------------------------------------ ------------------------------------------------ %SEDAR: 00010508E 

For further information: Dr. Robert Foster, President & CEO, Isotechnika Pharma Inc., (780) 487-1600 (247), (780) 484-4105 (fax), [ rfoster@isotechnika.com ]; Mr. Dennis Bourgeault, Chief Financial Officer, Isotechnika Pharma Inc., (780) 487-1600 (226), (780) 484-4105 (fax), [ dbourgeault@isotechnika.com ]