Calgary, Alberta
March 17, 2008
Canadian biotechnology company
advances pharmaceutical programs while executing on
non-pharmaceutical opportunities
SemBioSys Genetics Inc.
(TSX:SBS), a biotechnology company developing a portfolio of
therapeutic proteins for
metabolic and cardiovascular diseases, today announced its
operational and financial results for the twelve-month period
ended December 31, 2007. "We made progress on multiple product
candidates during 2007 that was essential to setting the stage
for significant value creating milestones in 2008. We believe
that each of our candidates individually represent an exciting
and material opportunity to the growth of our company. The basis
for this growth is the flexibility of our proprietary
oilbody-oleosin technology which allows us to target multiple
markets that require high volume, cost-effective pharmaceutical
and non-pharmaceutical products," said Andrew Baum, President
and CEO of SemBioSys Genetics Inc. "Establishing Botaneco as a
separate operating company with genuine value creating potential
and achieving commercially viable levels of Apo AI accumulation
were some of the key highlights of the year for us.
Additionally, we have made significant progress on the insulin
program including the necessary preclinical work to submit an
IND in order to begin the Phase I/II clinical trial in the
second half of 2008. While we have adjusted the expected start
date of the insulin clinical trial, we believe the insulin
program represents just one of the important upcoming milestones
for SemBioSys in 2008. We also expect in vivo functional and
efficacy results from Apo AI(Milano), which has the potential to
attract partnership opportunities as well as further growth and
business development opportunities from Botaneco. Our recent
achievements have also begun to attract interest from new
potential partners that believe the capabilities of
our technology could address production and manufacturing
challenges in their market."
Operational Highlights
Pharmaceutical Products
- Successfully developed commercially viable levels of both
apolipoprotein AI (Apo AI) and apolipoprotein AI Milano (Apo
AI(Milano)) in safflower seed.
- Demonstrated the functional equivalence of the Company's
proprietary safflower-produced insulin to U.S. pharma grade
human insulin in animal models.
- Demonstrated with in vitro and in vivo assay studies that the
Company's safflower-produced insulin is chemically, structurally
and physiologically indistinguishable from U.S. pharma grade
human insulin.
- Confirmed the Company is eligible to pursue a Section
505(b)(2) regulatory path for safflower-produced insulin after
meeting with the U.S. Food and Drug Administration (FDA).
- Continued the necessary preclinical work, including
preparations for an animal toxicology study, to submit an
Investigational New Drug application (IND) to the FDA in order
to initiate a Phase I/II trial for safflower-produced insulin in
the second half of 2008.
Non-pharmaceutical Products
- Established Botaneco, a subsidiary dedicated to the
commercialization of SemBioSys' non-transgenic oilbody products
for the cosmetics, personal care and prescription topical
dermatology markets.
- Commissioned Botaneco's 10,000 square foot, state-of-the-art,
commercial scale manufacturing facility located in Calgary.
- Launched Hydresia(TM), Botaneco's first branded line of
natural oilbody-based ingredients, and subsequently signed the
Company's first national brand customer, Burt's Bees, the
largest natural personal care company in North America.
Subsequent to the end of the year, Burt's Bees launched three
products in the U.S. market containing Hydresia(TM), two body
washes and a hand soap.
- Produced sufficient safflower-produced ImmunoSphere(TM) Feed
Additive in Chile and the United States to enable the next stage
of the Company's development and commercialization plans.
Financials
Please note that prior to the third quarter of 2007, SemBioSys
operated under one segment. During the third quarter, Botaneco
completed the construction of its manufacturing facility and
SemBioSys began operating in
two reportable segments: (i) the Biopharmaceutical, Animal
Health, and Nutritional Oils segment focused on the Company's
lead pharmaceutical candidates, recombinant human insulin and
Apo AI, in addition to its animal
health product, ImmunoSphere(TM) and nutritional oils, DHA and
GLA and (ii) the Specialty Ingredients segment which will
manufacture and market branded lines of naturally derived base
emulsions and delivery systems used in the development of
cosmetic, personal care and prescription topical/dermatology
products through the Botaneco subsidiaries.
Total revenue for the twelve-month period ended December 31,
2007 was $1,222,823 compared with $523,258 for the corresponding
period in 2006. The difference is due mainly to a license fee
payment earned from our
collaboration agreement with Martek BioSciences Corporation in
the first half of 2007, and from product sales from
Hydresia(TM).
Total expenditures for the year ended December 31, 2007 were
$17,599,775 compared with $15,082,560 for the year ended
December 31, 2006.
Research and development expenses for the twelve-month period
ended December 31, 2007 were $8,044,121, compared with
$5,480,972 for the same period last year. The increase in
research and development costs is primarily from increased
laboratory supplies, personnel and outsourcing costs related to
preclinical activity and the related support costs in all areas
of research and development with an expanded focus on insulin
and Apo AI, as well as increased field planting costs for
ImmunoSphere(TM).
General and administrative expenses for the twelve-month period
ended December 31, 2007 were $4,528,184 compared with $4,013,653
for the corresponding period last year. The difference is due
mainly to the increased
general and administration support required for the overall
increased company activity including newly added staff and the
additional related support costs as well as increased recruiting
activities for senior management in Botaneco.
Intellectual property costs for the twelve-month period ended
December 31, 2007 were $1,569,095 compared with $3,467,045 for
the twelve-month period ended December 31, 2006. 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.
Business development costs for the twelve-month period ended
December 31, 2007 were $1,213,634, compared with $745,964 for
the corresponding period last year. The difference is primarily
related to the commercialization activities of Botaneco
including increased staffing levels and increased contractor and
consulting time.
Net loss for the twelve-month period ended December 31, 2007 was
$15,418,677 or $0.71 per share, compared to a net loss of
$14,127,086 or $0.85 per share for the twelve-month period ended
December 31, 2006.
As at December 31, 2007 the Company had cash and cash
equivalents totaling $20,444,013 and a net positive working
capital balance of $19,518,408 compared to $16,328,459 and
$15,576,155, respectively, at December 31, 2006.
Total long-term debt at December 31, 2007 was $1,389,047
compared with $2,084,103 at December 31, 2006.
The increase in cash and working capital resulted primarily from
the completion of a $14,379,010 (net of issue costs) public
offering in the first quarter of 2007 and an $8,672,040 (net of
issue costs) private placement completed in November of 2007.
As at December 31, 2007 the Company had 25,886,676 common shares
outstanding, 4,322,000 warrants, and 1,335,224 options.
Outlook
SemBioSys is currently conducting all the necessary preclinical
work for safflower-produced insulin to enable it to file an IND
application with the FDA to proceed into human clinical trials
in the second half of 2008. The upcoming insulin milestone
events include:
- Completion of the toxicology studies of safflower-produced
insulin
- Completion of the production of clinical grade insulin supply
for use in Phase I/II human clinical trials
- Submission of an IND to the FDA in the second half of 2008
- Initiation of a 30 patient Phase I/II clinical trial of
safflower-produced insulin in the second half of 2008
- Continuation of business development activities toward an
insulin partnership
During 2007, SemBioSys successfully achieved commercial levels
of both Apo AI and Apo AI(Milano) accumulation in safflower. The
Company is currently conducting laboratory testing in an animal
model to establish equivalent functionality in animals of
safflower-produced Apo AI(Milano) to the Apo AI(Milano) that has
already been successfully used in human clinical trials.
The upcoming milestone events include:
- Completion of in vivo efficacy studies of cholesterol
mobilization with safflower-produced Apo AI and Apo AI(Milano)
- Completion of in vivo efficacy studies of plaque regression
with safflower-produced Apo AI(Milano)
- Initiation of formal partnering process for Apo AI and Apo
AI(Milano) upon receiving the initial in vivo efficacy results
- Initiation of the preparatory work in order to submit an IND
to the FDA for a Phase I clinical trial of Apo AI or Apo
AI(Milano) in the first half of 2009
In addition to its pharmaceutical milestones, the Company is
also advancing the development of its non-pharmaceutical
products. The upcoming milestone events expected from these
programs include:
- Expansion of the commercial distribution of the Company's
personal care topical oilbody products, specifically
Hydresia(TM), through Botaneco
- Pursuit of commercial opportunities for Hydresia(TM) in Europe
- Collection of two milestone payments from Arcadia Biosciences,
Inc., upon their successful commercial scale-up of GLA-rich
safflower oil
- Initiation of pond trials for the Company's shrimp feed
additive, ImmunoSphere(TM)
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
agricultural biotechnology markets. |
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