HAE:TSX
MONTREAL, Sept. 2 /PRNewswire-FirstCall/ - Haemacure Corporation , a Montreal-based specialty bio-therapeutics company developing high-value human plasma-derived protein products for commercialization, provides an activity update and reports third quarter results.
Fibrin Sealant Project - Hemaseel(R)HMN
During the third quarter, Haemacure completed the construction phase of its manufacturing facility, started processing plasma and began the validation of the facility. In June, Haemacure raised $7.8 million of equity through the exercise of warrants issued as part of the private placement completed in January 2007. Haemacure has also begun clinical sites visits and, with feedback from surgeons, is finalizing the protocol for the pivotal Phase II/Phase III clinical trials for its fibrin sealant. A partnership and collaboration strategy has been developed and the company is pursuing various options. Haemacure is also pursuing follow-on development activities aiming to expand the use of its lead product candidate, human fibrin sealant, beyond its primary haemostatic and tissue sealant function.
Plasma processing is proceeding as planned and the product and production process are meeting expectations. The validation and documentation phase has proven more time and resource consuming than planned and Haemacure will require more time to complete this phase. Additional resources are being deployed to complete this phase and Haemacure expects that this delay will move its first patient-in-the-clinic milestone by one quarter to calendar H1 2009 rather than Q1 2009. Haemacure anticipates commercial launch of the product on the U.S. market at the beginning of 2011, in line with the Corporation's previously announced guidance.
"I am very pleased with the progress we have made towards reaching our goal of a commercial launch at the beginning of 2011. Haemacure's platform extraction technology will provide very competitive advantages in terms of fibrin sealant performance and cost, and will be exploited in the only fibrin sealant manufacturing facility based in the United States for the U.S. market." said Joseph Galli, Chairman and CEO of Haemacure. "Concurrent with getting back into the clinic, we are focussing our efforts on partnering for the growing potential applications for our fibrin sealant. I look forward to an exciting next 12 months as we enter late stage clinical trials and partnering phases," concluded Mr. Galli.
Third Quarter Results
Revenues amounted to $25,593, as compared to $31,674 for the same quarter last year. Revenues are exclusively derived from the sale of legacy fibrin sealant application devices. The fluctuations in sales are mainly the result of changes in the Canadian/US dollar exchange rate. Operating expenses amounted to $2.0 million, as compared to $869,822 for the same quarter last year. The increase is mainly attributable to salaries and benefits resulting from the hiring of personnel, the purchase of supplies and raw material to begin plasma fractionation to produce fibrin sealant, and clinical trials-related activities.
Financial Position
Cash, cash equivalents and temporary investments amounted to $7.7 million as of July 31, 2008, as compared to $7.6 million as of October 31, 2007. In June 2008, a number of the warrants issued as part of the $12.5 million private placement completed in January 2007 were exercised, generating proceeds of $7.8 million.
Net Loss
The consolidated net loss for the quarter was $2.0 million, or $0.01 per share, up from a consolidated net loss of $856,879, or $0.01 per share, for the same quarter last year.
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 hemostats. Haemacure's lead product candidate, Hemaseel(R)HMN, is a fibrin sealant planned to enter pivotal Phase II/Phase III clinical trials during the first half of 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, skin graft fixation for burn injuries, combination with biomaterials, drug delivery, regenerative medicine, surgical hemostasis and wound healing. Haemacure has discovered 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, Quebec, and also operates offices in Sarasota, Florida through a wholly-owned subsidiary. 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
(unaudited)
CONTACT: Haemacure Corporation: Joseph Galli, Chairman and CEO, (514)
990-7074, jgalli@haemacure.ca; Gilles Lemieux, Corporate Secretary, (514)
282-3350 x22, glemieux@haemacure.ca; www.haemacure.com
