MONTREAL, Jan. 21 /PRNewswire-FirstCall/ - Haemacure Corporation (TSX:HAE), a Montreal-based specialty bio-therapeutics company developing high-value human plasma-derived protein products for commercialization, announces the results of the fiscal year ended October 31, 2008.
Operational Highlights - Building and commissioning of a manufacturing facility - Commencement of plasma fractionation for lead product candidate, an all-human fibrin sealant - Positive pre-clinical results in new potential indications for fibrin sealant in adhesion prevention and skin graft fixation - Addition of new board members and strengthening of team The most significant achievement of fiscal 2008 was the commencement of plasma fractionation at Haemacure's facility. Also of major significance were the positive results of preclinical studies conducted on the efficacy of Haemacure's proprietary all-human fibrin sealant in the prevention of the formation of post-surgical adhesions and in skin graft fixation for burn injuries. These preclinical studies are the first step towards the development of an expanded portfolio of indications for Haemacure's fibrin sealant based on its existing general hemostasis formulation. The year was also marked by significant additions to competencies as Haemacure was successful in recruiting Mr. Reinaldo M. Diaz and Dr. Thomas J. Lynch as new directors, as well as strengthening the management, operations and scientific teams. "2008 was a year of major accomplishments as we started processing plasma in our facility to meet our clinical trials timeline", said Mr. Joseph Galli, Chairman and Chief Executive Officer of Haemacure. "I am excited about the prospects for 2009 as we enter the clinic and continue to execute on our plan with a view to becoming a global player offering a next generation, all-human fibrin sealant", concluded Mr. Galli. Manufacturing Facility Haemacure is processing plasma at its state-of-the-art manufacturing facility located in Sarasota, Florida in preparation for the pivotal phase II/III clinical trials for its lead product candidate, a proprietary human fibrin sealant, which it plans on commencing mid-2009 under its IND currently open with the US FDA. The commercial launch of the fibrin sealant remains planned by mid-2011. Haemacure's facility is the only U.S.-based fibrin sealant manufacturing facility for the U.S. market, which is of significant strategic value. Financial Results Haemacure recorded revenues of $96,571 in fiscal 2008, as compared to $119,704 the prior year. Revenues consisted exclusively of legacy devices sales. Operating expenses totalled $8.9 million, up from $4.0 million the prior year. The increase is mainly attributable to the construction and validation of the manufacturing facility, hiring of personnel and consulting and professional services. Haemacure incurred a consolidated net loss of $8.8 million in fiscal 2008, or $0.05 per share, up from a net loss of $4.0 million, or $0.03 per share, the prior year. Haemacure is financing its current activities with the proceeds of the $7.8 million generated through the exercise in June 2008 of warrants issued as part of the private placement it completed in January 2007, and will require additional financing in the near term to support its operations. Complete financial statements for the fiscal year ended October 31, 2008 are available on Haemacure's web site, www.haemacure.com and have been filed on SEDAR. About Haemacure Haemacure Corporation is a specialty biotherapeutics company developing high-value human plasma-derived protein products for commercialization. Haemacure's research and development effort is driven by its proprietary plasma protein extraction technology to develop next-generation products, including surgical haemostats. Haemacure's lead product candidate, Hemaseel(R)HMN, is a fibrin sealant to enter pivotal Phase II/Phase III clinical trials during the first half of calendar 2009. Haemacure's second product candidate is thrombin, a component of its fibrin sealant, now in preclinical stage. Follow-on development will focus on the use of fibrin sealant in aesthetics, adhesion prevention, combination with biomaterials, drug delivery, regenerative medecine, skin graft fixation for burn injuries, and wound healing. Haemacure has identified eleven additional specialty proteins and enzymes in one if its two plasma fractions and seeks to advance these proteins and enzymes through partnerships with pharmaceutical and biotechnology companies. Haemacure is headquartered in Montreal, Canada and operates a wholly-owned subsidiary in Sarasota, Florida. The Corporation is traded under stock symbol HAE on the TSX. Forward-looking Statements Certain of the statements contained in this news release are forward-looking statements. Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown. Some examples of known risks are: the impact of general economic conditions, general conditions in the biotech industry, changes in the regulatory environment in the jurisdictions in which Haemacure does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation or otherwise. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. Haemacure disclaims any intention or obligation to update these statements. Financial Highlights Fiscal Years ended October 31 (in Canadian dollars) 2008 2007 ------ ------ $ $ Sales 96,571 119,704 Cost of sales 43,574 66,820 Expenses 8,878,727 4,018,552 Net loss (8,825,730) (3,965,668) Loss per common share (0.05) (0.03) Weighted average number of outstanding common shares 180,160,531 140,300,698 As at As at October 31, October 31, 2008 2007 ------------ ------------ $ $ Cash and cash equivalents 1,205,500 3,591,883 Investments 3,398,496 4,011,200 Other receivables 91,964 47,905 Total assets 13,033,252 10,939,289 Shareholders' equity 8,818,586 9,226,329
|SOURCE Haemacure Corporation|
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