SemBioSys Genetics Inc. News
SemBioSys announces first quarter 2008 financial and operational results
Highlights - Prepared pilot scale quantities of insulin from its facilities and initiated the final animal toxicology study for safflower-produced insulin - Initiated animal studies of the Company's safflower-produced Apo AI(Milano) that will provide important cholesterol mobilization data, subsequent to the end of the quarter - Announced Burt's Bees launched three products containing Hydresia(TM) in the U.S. personal care market, representing Botaneco's (a wholly- owned subsidiary of SemBioSys) first national brand name customer - Received a $350,000 milestone payment from AVAC Ltd. in recognition of critical advances in the Company's safflower-produced insulin program and a $500,000 milestone payment from AVAC to support the commercial activities of Botaneco - Launched the second generation oleosome product, Hydresia(TM) G2, subsequent to the end of the quarter 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 in the second half of 2008 which would then, pending feedback from the FDA, allow it to proceed into human clinical trials in the second half of 2008. The upcoming insulin milestone events include:
- Submission of an IND to the FDA in the second half of 2008 upon 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 - Upon FDA approval, 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
In 2007, SemBioSys successfully achieved commercial levels of both Apo AI and
- Completion of in vivo efficacy studies of cholesterol mobilization with safflower-produced Apo AI(Milano) - Completion of in vivo efficacy studies of plaque remodeling with safflower-produced Apo AI(Milano) followed by studies of plaque regression - Initiation of a formal partnering process for Apo AI and Apo AI(Milano) upon receiving the initial in vivo efficacy results
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) and Hydresia(TM) G2, through Botaneco, including Europe - Collection of milestone payments from Arcadia Biosciences, Inc., upon their successful commercial scale-up of High GLA Safflower Oil - Initiation of pond trials for the Company's shrimp feed additive, ImmunoSphere(TM)
"During the quarter, we took an important step that should allow us to begin the clinical trials for our safflower-produced insulin, with the initiation of the animal toxicology study required before the submission of an IND. We intend to submit that IND in the coming months and, if granted approval by the FDA, initiate a Phase I/II trial during the second half of 2008," said
Financials
Please note that prior to the third quarter of 2007, SemBioSys operated under one segment. During the third quarter of 2007, 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 three-month period ended
Total expenditures for the three-month period ended
Research and development expenses for the three-month period ended
General and administrative expenses for the three-month period ended
Intellectual property costs for the three-month period ended
Business development costs for the three-month period ended
Net loss for the three-month period ended
As of
As at
About SemBioSys Genetics Inc. (www.sembiosys.com)
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.
SemBioSys Genetics Inc. Consolidated Balance Sheets (Unaudited) ————————————————————————————————————- (expressed in Canadian dollars) March 31, December 31, 2008 2007 $ $ ————————————————————————————————————- Assets Current assets Cash and cash equivalents 16,284,778 20,444,013 Accounts receivable 150,468 583,591 Interest receivable 100,572 30,321 Prepaid expenses and deposits 452,613 538,718 Inventory 534,549 426,641 —————— —————— 17,522,980 22,023,284 Property and equipment 9,159,890 9,272,415 —————— —————— 26,682,870 31,295,699 —————— —————— —————— —————— Liabilities Current liabilities Accounts payable and accrued liabilities 1,643,022 1,875,397 Short-term portion of long-term debt 619,829 629,479 —————— —————— 2,262,851 2,504,876 Deferred cost recoveries 169,629 286,596 Long-term debt 1,311,133 759,568 —————— —————— 3,743,613 3,551,040 —————— —————— —————— —————— Shareholders' Equity Capital stock 70,427,920 70,396,170 Warrants 6,180,690 6,180,690 Contributed surplus 7,506,865 7,326,962 Deficit (61,176,218) (56,159,163) —————— —————— 22,939,257 27,744,659 —————— —————— 26,682,870 31,295,699 —————— —————— —————— —————— SemBioSys Genetics Inc. Consolidated Statements of Loss, Comprehensive Loss and Deficit (Unaudited) ————————————————————————————————————- (expressed in Canadian dollars, except shares) Three month period ended March 31, March 31, 2008 2007 $ $ Revenue Licensing fees 50,110 437,012 Contract research - 105,776 Product sales 159,917 - —————— —————— 210,027 542,788 Expenses Research and development 2,794,103 1,743,973 General and administration 1,395,275 1,023,711 Intellectual property costs 342,330 528,249 Business development 159,630 309,474 Sales and marketing 153,160 - Cost of products sold 271,745 - Stock-based compensation 179,903 179,050 Amortization 493,834 228,058 Cost recoveries (532,369) (69,107) —————— —————— 5,257,611 3,943,408 —————— —————— Loss before the undernoted (5,047,584) (3,400,620) —————— —————— —————— —————— Interest income 170,858 212,233 Interest expense (61,664) (57,973) Foreign exchange gain (loss) (78,665) 17,949 —————— —————— —————— —————— 30,529 172,209 —————— —————— Net loss and comprehensive loss for the period (5,017,055) (3,228,411) Deficit - Beginning of period (56,159,163) (40,740,486) —————— —————— Deficit - End of period (61,176,218) (43,968,897) —————— —————— —————— —————— Loss per share - basic and diluted (0.19) (0.17) —————— —————— —————— —————— Weighted average shares outstanding 25,935,792 18,916,227 —————— —————— —————— —————— SemBioSys Genetics Inc. Consolidated Statements of Cash Flows (Unaudited) ————————————————————————————————————- (expressed in Canadian dollars) Three month period ended March 31, March 31, 2008 2007 $ $ Cash provided by (used in) Operating activities Net loss for the period (5,017,055) (3,228,411) Add items not affecting cash: Amortization 493,834 228,058 Stock-based compensation 179,903 179,050 Unrealized foreign exchange loss (gain) 44,011 (21,010) Non-cash interest expense 18,780 - —————— —————— (4,280,527) (2,842,313) —————— —————— —————— —————— Change in non-cash working capital and other balances related to operations 209,916 1,481,767 —————— —————— Cash used in operating activities (4,070,611) (1,360,546) —————— —————— —————— —————— Financing activities Issuance of capital stock - 15,904,488 Share issue costs (57,884) (1,356,539) Exercise of stock options 31,750 4,500 Repayment of long-term debt (152,546) (183,969) Proceeds from long-term debt 634,900 - Repayment of repayable advances - (85,640) —————— —————— Cash provided by financing activities 456,220 14,282,840 —————— —————— —————— —————— Investing activities Acquisition of property and equipment (544,844) (444,816) —————— —————— Cash used in investing activities (544,844) (444,816) —————— —————— —————— —————— Increase (decrease) in cash and cash equivalents (4,159,235) 12,477,478 Cash and cash equivalents - Beginning of period 20,444,013 16,328,459 —————— —————— —————— —————— Cash and cash equivalents - End of period 16,284,778 28,805,937 —————— —————— —————— —————— Supplemental Information Cash interest received 100,607 603,639 Cash interest paid 28,755 51,422 Non-cash transactions Capital items included in accounts payable 112,838 469,161 Share issue costs included in accounts payable - 168,939 —————— —————— —————— ——————
SOURCE SemBioSys Genetics Inc.
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