CALGARY, Nov. 1 /PRNewswire-FirstCall/ - SemBioSys Genetics Inc. , a biotechnology company developing a broad pipeline of protein- based pharmaceutical product candidates and non-pharmaceutical products, today announced its 2005 third quarter operational and financial results.
“SemBioSys has already met a number of significant non-pharmaceutical product milestones this year in collaboration with our partners Lonza and Dow AgroSciences. As we approach the important insulin and Apo AI milestones relating to the commercial level of expression in safflower, we intend to demonstrate the same disciplined execution on these milestones as we have with our non-pharmaceutical product milestones,” said Andrew Baum, President and CEO of SemBioSys Genetics Inc. “Achievement of our non-pharmaceutical product milestones allows us to generate short and intermediate term income and build our product development infrastructure as we advance our pharmaceutical product candidates through the clinic.”
Operational Highlights - Announced successful completion of animal vaccine feasibility program with Dow AgroSciences LLC. - Expanded the in-house plant growth facility to provide additional capacity for plant research and development operations. - Demonstrated progress through increased levels of insulin and Apo AI expression in Arabidopsis.
Also this quarter the FDA advisory committee on Endocrinologic and Metabolic Drugs recommended approval of Exubera(R), the first inhaled insulin product submitted to the FDA. Approval and commercialization of alternate insulin delivery technologies and increased incidence of diabetes are the two leading factors that will drive future demand of insulin production.
Financial Highlights
Total revenues for the third quarter were $682,678 compared with $455,760 for the same period last year. Revenues were generated from licensing fees, which were $304,331 for the third quarter compared with $124,052 for the same period last year, and contract research, which was $378,347 for the third quarter compared with $331,708 for the same period last year. Total revenues for the nine-month period ended September 30, 2005 were $1,731,092 compared with $952,292 for the corresponding period last year.
Total expenditures for the three-month and nine-month periods ended September 30, 2005 were $2,616,685 and $6,842,304 respectively, compared with $1,758,284 and $5,218,818 for the corresponding periods last year.
Research and development expenses for the three-month and nine-month periods ended September 30, 2005 were $1,186,560 and $3,266,128 respectively, compared with $1,001,989 and $2,829,115 for the corresponding periods last year.
General and administrative expenses for the three-month and nine-month periods ended September 30, 2005 were $867,271 and $2,565,659 respectively, compared with $625,102 and $2,093,093 for the corresponding periods last year.
Net loss for the 2005 third quarter was $1,845,181 or ($0.15) per share, compared to a net loss of $1,288,652 or ($0.24) per share for the same period last year. Net loss for the nine-month period ended September 30, 2005 was $4,799,115 or ($0.38) per share compared with $4,277,476 or ($0.79) per share for the same nine-month period last year.
As at September 30, 2005 the Company had cash and cash equivalents totaling $14,291,626, compared with $18,836,396 cash and cash equivalents at December 31, 2004.
These unaudited financial statements are prepared in accordance with Canadian generally accepted accounting principles.
Outlook
SemBioSys’ current pharmaceutical product candidate priorities are to achieve commercial levels of expression of insulin and Apo AI in safflower. Its non-pharmaceutical product priorities include the continued development of its ImmunoSphere(TM) Feed Additive and DHA rich safflower oil programs. The upcoming milestone events include:
- First royalties from sales of DermaSphere(TM); - Apo AI animal data results; - Final delivery of GLA pre-commercial safflower lines to Arcadia Biosciences; - Achievement of commercial levels of insulin expression in safflower; and - Achievement of commercial levels of Apo AI expression in safflower. 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 protein-based pharmaceuticals 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 health, industrial and human topical markets. SemBioSys currently has five major funded partnership agreements with Syngenta Participations AG, Martek Biosciences Corporation, Lonza Inc., Dow AgroSciences LLC and Arcadia Biosciences, Inc.
Except for historical information, this press release may contain forward-looking statements, which reflect the Company’s current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are 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 quarterly and annual reporting.
Financial Results attached: SemBioSys Genetics Inc. Consolidated Balance Sheets (Unaudited) As at September 30, 2005 and December 31, 2004 ------------------------------------------------------------------------- (expressed in Canadian dollars) September 30, December 31, 2005 2004 ------------- ------------ $ $ Assets Current assets Cash and cash equivalents 14,291,626 18,836,396 Accounts receivable 716,105 458,995 Investment tax credits receivable 750,000 750,000 Prepaid expenses, deposits and other 167,015 99,739 ------------- ------------ 15,924,746 20,145,130 Property and equipment 4,571,011 3,522,102 ------------- ------------ 20,495,757 23,667,232 ------------- ------------ ------------- ------------ Liabilities Current liabilities Accounts payable and accrued liabilities 909,533 902,617 Repayable advances 275,822 275,822 Short-term portion of long-term debt 182,534 173,683 ------------- ------------ 1,367,889 1,352,122 Deferred cost recoveries 137,007 354,062 Deferred revenue 343,742 906,759 Long-term debt 118,163 256,326 ------------- ------------ 1,966,801 2,869,269 ------------- ------------ Shareholders’ Equity Capital stock 37,252,845 35,619,699 Contributed surplus 79,736 - Warrants 5,784,345 4,967,119 Deficit (24,587,970) (19,788,855) ------------- ------------ 18,528,956 20,797,963 ------------- ------------ 20,495,757 23,667,232 ------------- ------------ ------------- ------------ SemBioSys Genetics Inc. Consolidated Statements of Operations and Deficit (Unaudited) ------------------------------------------------------------------------- (expressed in Canadian dollars) Three month period Nine month period ended September 30, ended September 30, -------------------------- -------------------------- 2005 2004 2005 2004 -------------------------- -------------------------- $ $ $ $ ------------ ------------ ------------ ------------ Revenue Licensing fees 304,331 124,052 679,635 187,276 Contract research 378,347 331,708 1,051,457 765,016 ------------ ------------ ------------ ------------ 682,678 455,760 1,731,092 952,292 ------------ ------------ ------------ ------------ Expenses Research and development 1,186,560 1,001,989 3,266,128 2,829,115 General and administration 867,271 625,102 2,565,659 2,093,093 Intellectual property costs 325,561 260,392 774,321 766,598 Business development 133,707 38,854 372,197 405,190 Stock-based compensation 56,660 - 79,736 - Amortization 151,351 138,380 374,505 439,032 Cost recoveries (104,425) (131,433) (590,242) (789,210) Investment tax credits - (175,000) - (525,000) ------------ ------------ ------------ ------------ 2,616,685 1,758,284 6,842,304 5,218,818 ------------ ------------ ------------ ------------ Loss before the undernoted (1,934,007) (1,302,524) (5,111,212) (4,266,526) ------------ ------------ ------------ ------------ Interest expense (5,158) (45,086) (18,231) (139,183) Interest income 90,383 22,242 305,294 112,021 Gain on sale of asset 300 - 8,764 - Foreign exchange gain 3,301 36,716 16,270 16,212 ------------ ------------ ------------ ------------ 88,826 13,872 312,097 (10,950) ------------ ------------ ------------ ------------ Loss for the period (1,845,181) (1,288,652) (4,799,115) (4,277,476) Deficit - Beginning of period (22,742,789) (17,085,186) (19,788,855) (14,096,362) ------------ ------------ ------------ ------------ Deficit - End of period (24,587,970) (18,373,838) (24,587,970) (18,373,838) ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ Loss per share - basic and diluted (0.15) (0.24) (0.38) (0.79) ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ SemBioSys Genetics Inc. Consolidated Statements of Cash Flows (Unaudited) ------------------------------------------------------------------------- (expressed in Canadian dollars) Three month period Nine month period ended September 30, ended September 30, -------------------------- -------------------------- 2005 2004 2005 2004 ------------ ------------ ------------ ------------ Cash provided by (used in) Operating activities Loss for the period (1,845,181) (1,288,652) (4,799,115) (4,277,476) Add: Amortization 151,351 138,380 374,505 439,032 Accretion of convertible promissory note - 38,914 - 112,406 Gain on sale of property and equipment (300) - (8,764) - Stock based compensation 56,660 - 79,736 - Unrealized foreign exchange gain - (65,230) - (26,578) ------------ ------------ ------------ ------------ (1,637,470) (1,176,588) (4,353,638) (3,752,616) Net change in non-cash working capital (306,300) (547,285) (1,278,620) (1,269,197) ------------ ------------ ------------ ------------ Cash used in operating activities (1,943,770) (1,723,873) (5,632,258) (5,021,813) ------------ ------------ ------------ ------------ Financing activities Issuance of capital stock - 325 2,645,986 37,075 Deferred charges - (455,025) - (597,276) Share issue costs - - (195,614) - Proceeds from long-term debt - - - 40,698 Repayment of long-term debt (44,016) (40,837) (129,312) (113,971) ------------ ------------ ------------ ------------ Cash provided by (used in) financing activities (44,016) (495,537) 2,321,060 (633,474) ------------ ------------ ------------ ------------ Investing activities Proceeds on sale of property and equipment 300 - 12,300 - Acquisition of property and equipment (783,314) (187,289) (1,245,872) (284,131) ------------ ------------ ------------ ------------ Cash used in investing activities (783,014) (187,289) (1,233,572) (284,131) ------------ ------------ ------------ ------------ Decrease in cash and cash equivalents (2,770,800) (2,406,699) (4,544,770) (5,939,418) Cash and cash equivalents - Beginning of period 17,062,426 5,910,321 18,836,396 9,443,040 ------------ ------------ ------------ ------------ Cash and cash equivalents - End of period 14,291,626 3,503,622 14,291,626 3,503,622 ------------ ------------ ------------ ------------ ------------ ------------ ------------ ------------ Supplemental Information Interest received 90,383 22,242 305,295 112,021 Interest paid 5,163 8,340 18,219 26,777 Non-cash transactions Deferred charges included in accounts payable - 243,931 - 243,931 Capital items included in accounts payable 181,078 - 181,078 -
SemBioSys Genetics Inc.
CONTACT: SemBioSys Genetics Inc., Mr. Andrew Baum, President and ChiefExecutive Officer, Phone: (403) 717-8767, Fax: (403) 250-3886, E-mail:bauma@sembiosys.com, Internet: www.sembiosys.com; Investor Relations, RossMarshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext. 238), Fax:(416) 815-0080, E-mail: rmarshall@equicomgroup.com
