MONTREAL, Dec. 20 /PRNewswire-FirstCall/ - Haemacure Corporation , a Montreal-based specialty bio-therapeutics company, announces the results of the fiscal year ended October 31, 2007 and provides an update on activities.
Results
Haemacure recorded revenues of $119,704 in fiscal 2007, as compared to $147,134 the prior year. Revenues consisted exclusively of legacy devices sales. Operating expenses totalled $4.0 million, up 29% from $3.1 million the prior year. The increase is mainly attributable to the construction of the manufacturing facility, the setting-up of a laboratory, business development and investor relations activities, regulatory affairs, and stock-based compensation resulting from stock option grants. Haemacure incurred a consolidated net loss of $3.97 million in fiscal 2007, or $0.03 per share, up from a net loss of $3.01 million, or $0.08 per share, the prior year.
“I am very pleased and excited with our progress since February 1, 2007 in restructuring and setting a new direction for the Company”, said Mr. Joseph Galli, Chairman and Chief Executive Officer of Haemacure. “Given the current and future competitive conditions, Haemacure is poised to become a global, independent player with a next generation, all-human fibrin sealant”, concluded Mr. Galli.
First-Patient-In
Haemacure plans on having a first patient undergo surgery in the planned pivotal Phase II/Phase III clinical trials for its human fibrin sealant Hemaseel(R)HMN during the first quarter of calendar 2009. The trials will be carried out under the IND currently open with the US FDA.
Manufacturing Strategy
Haemacure is building a small-scale manufacturing facility in Sarasota, Florida where it will first produce its proprietary fibrin sealant for the planned pivotal Phase II/Phase III clinical trials and the commercial launch of the product in the United States.
The commissioning of this facility is the first stage of Haemacure’s two-stage manufacturing strategy announced last October. The timeline for the commercial launch of the fibrin sealant remains towards the end of 2010 or the beginning of 2011. The benefit of this two-phase strategy is that it requires lower capital expenditures than the original plan at the onset.
The second stage of the manufacturing strategy is to expand the launch facility into a larger scale facility and to complete the development of Haemacure’s second product candidate, the Hemaseel(R)Thrombin human haemostatic agent, now in pre-clinical stage.
Sample Fibrin Sealant for Evaluation
Haemacure is preparing to deliver small volumes of its proprietary fibrin sealant shortly to potential partners or clients that have requested sample product for evaluation in various applications. This delivery is a first step towards Haemacure’s objective of becoming a long-term supplier of human fibrin sealant to the wound management, regenerative medicine, drug delivery and biomaterials markets. The fibrin sealant to be delivered is produced by Haemacure at its Montreal laboratory.
Financing
Haemacure is financing its current activities with the net proceeds of the $12.5 million private placement it completed in January 2007 and will require additional financing during this fiscal year to support its operations plan.
Complete financial statements for the fiscal year ended October 31, 2007 are available on Haemacure’s web site, www.haemacure.com, and have been filed on SEDAR.
About Haemacure
Haemacure Corporation is a specialty bio-therapeutics company developing high-value human therapeutic proteins for commercialization. Haemacure’s research and development effort is driven by its proprietary plasma protein extraction technology to develop next-generation products, including surgical hemostats. Haemacure’s lead product candidate, Hemaseel(R)HMN, is a human-derived fibrin sealant planned to enter pivotal Phase II/Phase III clinical trials. Haemacure’s second product candidate is human thrombin, a component of its fibrin sealant. Both candidates have applications in the expanding bio-surgical market. Follow-on development will focus on surgical hemostats, adhesion prevention, regenerative medicine, drug delivery in select therapeutic areas and combinations with biomaterials. Haemacure has discovered additional specialty proteins in one of its two plasma fractions and seeks to advance these specialty proteins through partnerships with pharmaceutical and biotechnology companies. Haemacure is headquartered in Montreal (Quebec) Canada and operates offices in Sarasota, Florida through a wholly-owned subsidiary. The Corporation is traded under the stock symbol HAE on the TSX.
All dollar amounts set forth in this press release are in Canadian dollars, except where otherwise stated.
Forward-looking Statements
Certain of the statements contained in this news release may be 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 include, but are not limited to the following: the impact of general economic conditions, general conditions in the biotech industry, results and outcomes of Haemacure’s clinical trials, changes in the regulatory environment in the jurisdictions in which Haemacure Corporation 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 Corporation disclaims any intention or obligation to update these statements.
CONTACT: Haemacure Corporation: Joseph Galli, Chairman of the Board and
CEO, (514) 990-7074; Gilles Lemieux, Secretary, (514) 282-3350 ext. 22,
www.haemacure.com
