Calgary, Alberta
November 6, 2006
Canadian biotechnology company
achieves commercially viable levels of insulin production in
safflower
SemBioSys Genetics Inc.
(TSX:SBS), a biotechnology company developing a broad pipeline
of protein-based
pharmaceuticals and non-pharmaceutical products, today announced
its 2006 third quarter operational and financial results.
"During the third quarter we
exceeded our targeted levels of insulin expression in safflower,
our commercial crop system. We achieved 1.2 percent accumulation
of insulin per total seed protein. These results confirm both
the
economic and scientific potential of plant-produced insulin,"
said Andrew Baum, President and CEO of SemBioSys Genetics Inc.
"Despite the efforts of other groups no one has ever
demonstrated commercially viable production of insulin in plants
let alone in a flexible and scalable seed-based plant system
like safflower. We believe this scientific achievement is a
major step forward in the production of proteins that face cost
and supply barriers for
successful commercialization. In the near term, we expect to
announce the specific regulatory path we intend to follow in the
United States and announce the results of bioequivalence studies
that compare safflower-produced insulin to commercially
available products."
Financials
Total revenues for the three-month
and nine-month periods ended September 30, 2006 were $123,039
and $390,570 respectively, compared with $682,678 and $1,731,092
for the corresponding periods in 2005. Total revenue for the
three-month and nine-month periods ended September 30, 2006
consisted entirely of contract research compared with contract
research revenue of $378,347 and $1,051,457 for the
corresponding periods last year. The difference related to
contract research is a result of the completion of collaboration
agreements with Dow AgroSciences LLC and Arcadia Biosciences,
Inc. since 2005, such that the contract research revenue from
the third quarter of 2006 relates solely to the ongoing
collaboration agreement with Martek Biosciences Corporation. In
2006 there were no license fees earned compared with $304,331
and $679,635 generated during the three-month and nine-month
periods ended September 30, 2005 as a result of the agreements
with Lonza Inc. and Arcadia moving from a research and
development stage to a commercialization stage.
Total expenditures for the
three-month and nine-month periods ended September 30, 2006 were
$2,949,791 and $10,706,226 respectively, compared with
$2,616,685 and $6,842,304 for the corresponding periods last
year.
Research and development expenses for the three-month and
nine-month periods ended September 30, 2006 were $1,360,045 and
$3,843,207, compared with $1,186,560 and $3,266,128 for the
corresponding periods last year. The difference is primarily
attributable to increased personnel and related support costs.
This includes an enhanced quality control and assurance program,
the further development of a stronger preclinical and clinical
team to allow the Company to advance its insulin program, and
the development of prospective future pipeline candidates. The
Company has also expanded the plant growth team and
infrastructure both indoors and in the field. It is expected
that the Company's research and development costs will continue
to increase as it enters clinical development.
General and administrative
expenses for the three-month and nine-month periods ended
September 30, 2006 were $903,753 and $2,695,669 respectively,
compared with $867,271 and $2,565,659 for the corresponding
periods last year.
Intellectual property costs for
the three-month and nine-month periods ended September 30, 2006
were $217,269 and $2,561,564 respectively, compared with
$325,561 and $774,321 for the corresponding periods last year.
The difference in intellectual property costs for the current
quarter over the corresponding period from last year is due to
the fact that a large portion of the costs relate to patent
maintenance and prosecution which do not occur uniformly. With
the exclusion of the one time Syngenta intellectual property
acquisition of $1.52 million that was incurred in the second
quarter of 2006, the year to date increase over the prior year
period is $270,337.
Business development costs for the
three-month and nine-month periods ended September 30, 2006 were
$134,182 and $586,279 respectively, compared with $133,707 and
$372,197 for the corresponding periods last year. The difference
for the nine-month period is primarily as a result of
accelerated activities related to the commercialization of the
Company's products and a further assessment of new product
candidates.
Net loss for the 2006 third
quarter was $2,659,025 or ($0.16) per share, compared to a net
loss of $1,845,181 or ($0.15) per share for the same period last
year. Net loss for the nine-month period ended September 30,
2006 was $9,771,546 or ($0.59) per share compared with
$4,799,115 or ($0.38) for the same nine-month period last year.
As of September 30, 2006 the Company had cash and cash
equivalents totaling $20,614,674 compared to $28,513,095 on
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(TM) and docosahexaenoic acid
(DHA) rich safflower oil. The upcoming milestone events expected
in 2006 and the first half of 2007 include:
- Clarification of the regulatory
pathway for safflower produced insulin with the FDA
- Bioequivalence results, in vivo and in vitro, comparing
safflower-produced insulin to commercially available insulin
products
- Execution of a Contract Manufacturing Agreement to manufacture
insulin for preclinical and early stage clinical trials
- Initiation of a new pharmaceutical product development program
- Scale-up of ImmunoSphere(TM) Shrimp Feed Additive in the
United States and Chile for commercial launch
- Achievement of a key DHA proof-of-concept milestone
- Achievement of commercial levels of Apo AI expression in
safflower and animal data from plant-derived Apo AI
About SemBioSys Genetics Inc. (www.sembiosys.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(TM) 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. |