Calgary, Alberta, Canada
August 4, 2006
SemBioSys Genetics Inc.
(TSX:SBS), a biotechnology company developing a broad pipeline
of protein-based pharmaceuticals and non-pharmaceutical
products, today announced its 2006 second quarter operational
and financial results.
Second Quarter Highlights
- Achieved its commercial
target levels of human insulin accumulation in safflower
with 1.2 percent of total seed protein, exceeding its target
of one percent total seed protein by 20 percent, subsequent
to the end of the quarter.
- Announced the completion
of key milestones in its GLA rich safflower oil project with
Arcadia Biosciences, Inc. with the delivery of safflower
seeds from plant lines containing gamma linolenic acid
(GLA), transformed utilizing Arcadia's proprietary genes.
- Announced an agreement
with Syngenta Crop Protection AG to acquire technology
assets and in-license intellectual property related to the
manufacture of biopharmaceuticals in safflower, which allow
SemBioSys to further increase its efficiency in the
development of transgenic safflower.
- Successfully planted
safflower in the United States as part of the commercial
scale-up of ImmunoSphereTM Feed Additive.
“Achieving commercial levels of
insulin accumulation in safflower is the most significant
milestone for the Company to date. We expect to have results
from bioequivalence studies in animals comparing
safflower-produced insulin to commercially available insulin in
the fourth quarter of this year,” said Andrew Baum, President
and CEO of SemBioSys Genetics Inc. “We believe
safflower-produced insulin can dramatically impact the economics
of insulin manufacturing and act as an enabling technology in
two ways. Safflower-produced insulin has the potential to be a
cost-effective method to meet the increased demand for insulin
required by new delivery methods, such as inhalation, which
requires five to ten times the insulin as injectable methods.
Safflower-produced insulin also has the potential to provide
insulin to people in the developing world, who otherwise would
not have access to it because there is not enough supply or they
cannot afford it.”
Financials
Total revenues for the three-month
and six-month periods ended June 30, 2006 were $167,445 and
$267,531 respectively, compared with $561,697 and $1,048,414 for
the corresponding periods in 2005. In 2006 there were no license
fees earned compared with $248,126 and $375,304 generated during
the three-month and six-month periods ended June 30, 2005 as a
result of the agreements with Lonza Inc. and Arcadia
Biosciences, Inc. moving from a research and development stage
to a commercialization stage. In addition, the difference
related to contract research is a result of the completion of
collaboration agreements with Dow AgroSciences LLC and Arcadia
since 2005, such that the contract research revenue from the
second quarter of 2006 relates primarily to only the ongoing
collaboration agreement with Martek Biosciences Corporation.
Total expenditures for the
three-month and six-month periods ended June 30, 2006 were
$5,007,483 and $7,756,437 respectively, compared with $2,233,213
and $4,225,619 for the corresponding periods last year.
Research and development expenses for the three-month and
six-month periods ended June 30, 2006 were $1,375,635 and
$2,483,161, compared with $1,202,242 and $2,079,568 for the
corresponding periods last year. The difference is primarily
related to the continued development of a stronger preclinical
and clinical team to allow the Company to further advance the
insulin program, and prospective future pipeline candidates. The
Company also expanded the plant growth team and infrastructure
both indoors and in the field.
General and administrative
expenses for the three-month and six-month periods ended June
30, 2006 were $819,659 and $1,791,919 respectively, compared
with $857,973 and $1,698,388 for the corresponding periods last
year.
Intellectual property costs for
the three-month and six-month periods ended June 30, 2006 were
$2,081,258 and $2,344,295 respectively, compared with $240,160
and $448,760 for the corresponding periods last year. This
difference is primarily attributable to the acquisition of
technology assets and in-licensing of intellectual property from
Syngenta. In exchange for these assets the Company issued
warrants that allow Syngenta to purchase an aggregate of 550,000
common shares of SemBioSys at an exercise price of $13.21 per
share. This resulted in a charge to intellectual property
expense of $1.52 million during the second quarter, which is
consistent with the Company’s accounting policy of expensing
these costs as incurred. The term of the warrants is five years.
The warrants are not listed on the Toronto Stock Exchange.
Business development costs for the
three-month and six-month periods ended June 30, 2006 were
$267,292 and $452,097 respectively, compared with $181,191 and
$238,490 for the corresponding periods last year. The difference
is primarily related to accelerated activities related to the
commercialization of the Company’s products and a further
assessment of new product candidates.
Net loss for the 2006 second
quarter was $4,608,182 or ($0.28) per share, compared to a net
loss of $1,558,076 or ($0.12) per share for the same period last
year. Net loss for the six-month period ended June 30, 2006 was
$7,112,521 or ($0.43) per share compared with $2,953,934 or
($0.23) for the same six-month period last year.
As at June 30, 2006 the Company had cash and cash equivalents
totaling $22,874,534 compared to $28,513,095 at December 31,
2005.
Outlook
The Company’s priorities for 2006
are to complete bioequivalence studies of safflower-produced
insulin and to advance the development of its non-pharmaceutical
products, including ImmunoSphere™ and docosahexaenoic acid
(DHA) rich safflower oil. With the experience gained from the
successful completion of insulin accumulation in safflower the
Company now expects commercial levels of expression results in
safflower of apolipoprotein AI (Apo AI) in late 2006 or early
2007. The upcoming milestone events expected in 2006 include:
• Bioequivalence results comparing
safflower-produced insulin to commercially available insulin
products
• Initiation of a new pharmaceutical product development program
• Scale-up of ImmunoSphere™ product in the United States and
Chile for commercial launch in late 2007
• Achievement of key DHA proof-of-concept milestone
Additional information about the
Company, including the MD&A and financial results may be found
on SEDAR at www.sedar.com.
Calgary, Alberta-based
SemBioSys Genetics Inc. is a biotechnology company focused on
the development, commercialization and production of
biopharmaceuticals and non-pharmaceutical products based on its
plant genetic engineering skills and proprietary oilbody-oleosin
technology platform - the Stratosome™ Biologics System. Its two
lead pharmaceutical product candidates are insulin and a
developmental cardiovascular drug called Apo AI. It also has a
series of non-pharmaceutical products addressing animal and
aquaculture health, nutritional oils and human topical markets.
SemBioSys currently has funded partnership agreements with
Martek Biosciences Corporation, Lonza Inc. and Arcadia
Biosciences, Inc. |