CALGARY, March 17 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. , 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.”
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:
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:
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:
www.sembiosys.com
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.
This press release contains certain forward-looking statements, including, without limitation, statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and other similar expressions which constitute “forward-looking information” within the meaning of applicable Canadian securities laws. Forward-looking statements reflect the Company’s current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time-to-time in the Company’s ongoing filings with the Canadian securities regulatory authorities which filings can be found at www.sedar.com. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable Canadian securities laws.
CONTACT: SemBioSys Genetics Inc.: Mr. Andrew Baum, President and Chief
Executive Officer, Phone: (403) 717-8767, Fax: (403) 250-3886, E-mail:
bauma@sembiosys.com, Internet: www.sembiosys.com; Investor Relations: Ross
Marshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext. 238), Fax:
(416) 815-0080, E-mail: rmarshall@equicomgroup.com
