Calgary, Alberta
August 3, 2007
SemBioSys Genetics Inc.
(TSX:SBS), a biotechnology company developing a portfolio of
therapeutic proteins for
metabolic and cardiovascular diseases, today announced its 2007
second quarter operational and financial results.
Highlights
- Successfully developed
commercially viable levels of apolipoprotein AI and its
variant apolipoprotein AIMilano (collectively referred to as
Apo AI) in safflower seed lines, subsequent to quarter end.
- Presented positive
preclinical data supporting the development of recombinant
human insulin produced in safflower at the 67th Scientific
Sessions of the American Diabetes Association in Chicago.
- Construction of the
full-scale commercial manufacturing facility for the
Company's topical oilbody business is on schedule and on
budget and commercial scale production will begin in the
third quarter.
"With the recent
announcement from our Apo AI program, we are now actively
scaling-up production and conducting the necessary
preclinical work to start clinical trials for two
large-market protein products, insulin and
Apo AI," said Andrew Baum, President and CEO of SemBioSys
Genetics Inc. "We expect to receive data on the functional
equivalence of Arabidopsis-produced Apo AI to serum-derived
Apo AI from animal trials later this year. We also intend to
scale-up production and initiate functional equivalence
studies in animals of safflower-produced Apo AI immediately.
With respect to the insulin program, we expect to initiate a
Phase II clinical trial in early 2008 and anticipate data
from that trial toward the middle of 2008. In addition to
our progress on our pharmaceutical programs, we have also
increased our production capacity for our topical oilbody
product, DermaSphere(R), and are scaling-up production of
our shrimp feed additive, ImmunoSphere(TM), in preparation
for its commercial launch in early 2008."
Outlook
The Company has completed the major scientific milestones
necessary to proceed into human clinical trials of
safflower-produced insulin in early 2008. Additional insulin
milestone events expected in 2007 include:
- Complete the
preclinical testing of safflower-produced insulin
- Complete the
technology transfer and scale-up of insulin processing
and formulation to the Company's contract manufacturer
for Phase II clinical material and production of
clinical grade material for early stage human trials
- Continue business
development activities toward an insulin partnership
- Submit an IND to the
FDA and prepare for Phase II clinical trial
With the Company's
recent achievement of successfully developing commercial
levels of Apo AI, the 2007 milestone events that the
Company expects from this program include:
- Functional
equivalence results comparing Arabidopsis-produced
Apo AI to serum-derived Apo AI from animal trials
- Functional
equivalence results comparing safflower-produced Apo
AI to serum-derived Apo AI from animal trials
In addition to the
above pharmaceutical milestones, the Company is also
advancing the development of its non-pharmaceutical
products. The 2007 milestone events expected from
these programs include:
- Increase
production capacity of personal care topical
oilbody products and establish distribution
channels for commercialization
- Initiate and
complete pond trials for the Company's shrimp
feed additive, ImmunoSphere(TM)
- Complete
development feed of formulation process using
harvested ImmunoSphere(TM) product
Financials
Total revenue for the three and six-month
periods ended June 30, 2007 were $459,407 and
$1,002,195 respectively, compared with $167,445
and $267,531 for the corresponding periods in
2006. The increase in revenue relates primarily
to the recognition of an upfront license fee
payment received from Martek and is offset by
the reduced level of research activity with
respect to the collaboration agreement with
Martek.
Total expenditures for the three and six-month
periods ended June 30, 2007 were $4,046,723 and
$7,990,131 respectively, compared with
$5,007,483 and $7,756,437 for the corresponding
periods last year.
Research and development expenses for the three
and six-month periods ended June 30, 2007 were
$1,924,745 and $3,668,717, compared with
$1,375,635 and $2,483,161 for the corresponding
periods last year. The difference is primarily
due to increased personnel and the related
support costs in all areas of research and
development with an expanded focus on
preclinical work for insulin and Apo AI, and
increased field planting costs incurred for
process development of the ImmunoSphere(TM)
product. The increased personnel costs are
primarily attributable to an enhanced quality
control and assurance program and further
development of a stronger preclinical and
clinical team.
General and administrative expenses for the
three and six-month periods ended June 30, 2007
were $1,086,766 and $2,110,477 respectively,
compared with $819,659 and $1,791,919 for the
corresponding periods last year. The difference
is mainly due to newly added staff and increased
investor relations activities as the Company
broadens its exposure to U.S. and European
markets.
Intellectual property costs for the three and
six-month periods ended June 30, 2007 were
$307,414 and $835,663 respectively, compared
with $2,081,258 and $2,344,295 for the
corresponding periods last year. This
difference is primarily attributable to a
$1,516,906 non-cash license fee incurred in the
second quarter of 2006 for the acquisition of
technology from Syngenta Crop Protection AG in
exchange for warrants and a decrease in patent
activity in the second quarter offset by an
increase in royalty payments that became due in
the same period.
Business development costs for the three and
six-month periods ended June 30, 2007 were
$404,434 and $713,909 respectively, compared
with $267,292 and $452,097 for the corresponding
periods last year. The difference is primarily
related to the further commercialization of the
oilbody business, increased staffing levels and
increased contractor and consulting time as the
Company's products progress further along in
their commercialization.
Net loss for the 2007 second quarter was
$3,225,371 or ($0.15) per share, compared to a
net loss of $4,608,182 or ($0.28) per share for
the same period last year. Net loss for the
six-month period ended June 30, 2007 was
$6,453,782 or ($0.31) per share compared with
$7,112,521 or ($0.43) for the same six-month
period last year.
As at June 30, 2007 the Company had cash and
cash equivalents totaling $22,877,784 compared
to $28,805,937 at March 31, 2007. Approximately
$2,112,436 has been spent to date on the
construction of the topical oilbody
manufacturing facility.
Calgary, Alberta-based SemBioSys Genetics
Inc. is a biotechnology company developing
protein-based pharmaceuticals for metabolic and
cardiovascular diseases. The Company's lead
pharmaceutical candidates, produced in the plant
host safflower, are recombinant human insulin to
serve the rapidly expanding global diabetes
market and Apo AI, a next generation
cardiovascular drug. In addition to its
pharmaceutical products, SemBioSys is developing
a series of non-pharmaceutical products
addressing human topical, nutritional oils and
animal health markets. |
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