LAVAL, QC, Aug. 13 /CNW/ - BioSyntech, Inc. ("BioSyntech" or "the
Company") (TSX: BSY), a biotechnology company developing biotherapeutic
thermogels for regenerative medicine, today announced financial results for
the first quarter ended June 30, 2007.
First Quarter Highlights:
- Completed the enrollment and treatment of a 20-patient subset of its
continuing Canadian-European pivotal trial of BST-CarGel(R). The six
month interim data collected from these patients will be submitted to
the U.S. Food and Drug Administration (FDA) as a pilot study in
support of an Investigational Device Exemption (IDE) for a U.S.
- Obtained regulatory approval for the first two European sites which
are part of the Canadian-European BST-CarGel(R) study. Two of the
five Spanish centers have received Institutional Review Board (IRB)
approval and are now actively recruiting patients.
"We remain focused on progressing with our clinical programs for
BST-CarGel(R) and BST-DermOn(TM). The current enrollment of 30% of the
targeted number of patients in the BST-CarGel(R) study brings us closer to
this goal," said Claude Leduc, President and CEO of BioSyntech. "The approval
of European clinical sites represents an additional significant boost for the
company towards completion of the BST-CarGel(R) pivotal trial. We believe that
involvement of key European centers will have a favourable impact on our
European regulatory and marketing strategy."
Revenues were $9,796 for the three month period ended June 30, 2007,
compared to $10,806 for the same quarter in the previous year. Research and
development expenses amounted to $1,419,565 for the first quarter compared to
$855,555 for the same period last year. This increase is primarily
attributable to the increase in expenses incurred for BST-CarGel(R) and
BST-DermOn(TM) multi-center clinical trials, the hiring of new employees
related to clinical development activities and by an increase in compensation
expenses related to options granted to employees. For the first quarter ended
June 30, 2007, BioSyntech recorded a net loss of $2,238,791 ($0.02 per share),
compared to $1,428,108 ($0.02 per share) for the same period last year. The
increased loss mainly reflects the increased research and development efforts
and the Company's organizational structure to develop its business plan.
As of June 30, 2007, liquidities comprised of cash, cash equivalents and
short-term investments totaled $9,470,874 compared to $11,925,979 at March 31,
2007. This decrease is reflective of the funds used for operating and
An expanded Management's Discussion and Analysis is accessible on the
BioSyntech website at www.biosyntech.com and with the Company's regulatory
filings at www.sedar.com.
BioSyntech is a biotechnology company specializing in the discovery,
development and manufacturing of innovative cost-effective and
physician-friendly biotherapeutic thermogels for regenerative medicine and
therapeutic delivery. BioSyntech's Quality Management System is registered to
ISO 9001:2000 standard. For additional information, visit www.biosyntech.com.
Forward Looking Statements
This press release contains forward-looking statements and information
which are subject to material risks and uncertainties. Such statements are not
historical facts and are based on the current expectations of management. You
are cautioned that such statements are subject to a multitude of risks and
uncertainties that could cause actual results, future circumstances, or events
to differ materially from those projected in the forward-looking information.
These risks include, but are not limited to, those associated with our
capacity to finance our activities, the adequacy, timing, and results or our
clinical trials, the regulatory approval process, competition, securing and
maintaining corporate alliances, market acceptance of the Company's products,
the availability of government and insurance reimbursements for the Company's
products, the strength of intellectual property, the success of research and
development programs, reliance on subcontractors and key personnel, and other
risks and uncertainties detailed from time-to-time in our filings with the
Canadian securities commissions.
Readers should not place undue reliance on the forward-looking
information, given that (i) our actual results could differ materially from a
conclusion, forecast or projection in the forward-looking information, and
(ii) certain material factors or assumptions which were applied in drawing a
conclusion or making a forecast or projection as reflected in the
forward-looking information, could prove to be inaccurate. Additional
information about (i) the material factors that could cause actual results to
differ materially from the conclusion, forecast or projection in the
forward-looking information, and (ii) the material factors or assumptions that
were applied in drawing a conclusion or making a forecast or projection as
reflected in the forward-looking information, is contained in the Company's
annual report and other documents filed from time to time with the Canadian
securities commissions which are available at www.sedar.com.
These statements speak only as of the date they are made, and we assume
no obligation to revise such statements as a result of any event, circumstance
or otherwise, except in accordance with law.
For further information:
For further information: BioSyntech, Inc.: Yvonne Kramer, Ph.D., Sr.
Director Corporate & Business Development, (450) 686-2437, ext. 315,
Yvonne.Kramer@biosyntech.com; François Michaud, Chief Financial Officer, (450)
686-2437, ext. 260, Francois.Michaud@biosyntech.com; Investor relations: The
Equicom Group Inc., Eric Bouchard, (514) 844-7997, firstname.lastname@example.org