Inflazyme Pharmaceuticals Ltd. Letter to Shareholders for Quarter and Financial Year Ended March 31, 2003.Business Editors/Health/Medical Writers RICHMOND Richmond, cities, United States Richmond. 1 City (1990 pop. 87,425), Contra Costa co., W Calif., on San Pablo Bay, an inlet of San Francisco Bay; inc. 1905. , British Columbia--(BUSINESS WIRE)--May 7, 2003 Inflazyme Pharmaceuticals Ltd. (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :IZP IZP Inorganic Zinc Primer IZP Inter-Zone Path ) Dear Shareholder: March 31, 2003, marks both the end of our fourth quarter and the end of our 2003 financial year. I would like to take this opportunity to update you on the Company's progress over the last quarter. The quarter was highlighted by the opening of our IND for IPL (Initial Program Load) Same as boot. 1. IPL - Information Processing Language. 2. IPL - Internet Public Library. 3. IPL - Initial Program Load. 4. IPL - Initial Program Loader. 512,602, a potential new oral treatment for respiratory diseases Noun 1. respiratory disease - a disease affecting the respiratory system respiratory disorder, respiratory illness adult respiratory distress syndrome, ARDS, wet lung, white lung - acute lung injury characterized by coughing and rales; inflammation of the , and the optioning of one of our phosphodiesterase phosphodiesterase /phos·pho·di·es·ter·ase/ (-di-es´ter-as) any of a group of enzymes that catalyze the hydrolytic cleavage of an ester linkage in a phosphoric acid compound containing two such ester linkages. 4 (PDE PDE Pennsylvania Department of Education PDE Plug-In Development Environment PDE Partial Differential Equation PDE Phosphodiesterases PDE Personal Digital Entertainment PDE Pulse Detonation Engine PDE Product Data Exchange PDE Present-Day English 4) inhibitors, IPL455,903, by Helicon Helicon (hĕl`ĭkŏn), Gr. Elikón, mountain group, c.20 mi (30 km) long, central Greece, in Boeotia; it rises to 5,736 ft (1,748 m). Helicon formed part of the border between ancient Boeotia and Phocis. Therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. Inc. Subsequent to the end of the quarter, on April 9, 2003, we announced that we had entered into a definitive agreement to acquire GlycoDesign, a Toronto Toronto (tərŏn`tō), city (1998 est pop. 2,400,000), provincial capital, S Ont., Canada, on Lake Ontario. Toronto is the largest city in Canada and since the 1970s has been one of the fastest-changing cities in North America, experiencing based biopharmaceutical company, which we believe expands our franchise in inflammation inflammation, reaction of the body to injury or to infectious, allergic, or chemical irritation. The symptoms are redness, swelling, heat, and pain resulting from dilation of the blood vessels in the affected part with loss of plasma and leucocytes (white blood and strengthens our product pipeline. During the quarter we saw our loss decline to $2.2 million compared to $3.0 million for the third quarter and $4.8 million for each of the first two quarters. This decreasing trend over the last half of the year was primarily due to lower clinical development expenses related to IPL512,602 in the last half of the financial year. In the fourth quarter, a successful food-effect study with IPL512,602 was completed, but the expenses were incurred by Aventis Aventis Is a pharmaceutical and lab assay testing company. It was formed in 1999 when Rhône-Poulenc S.A. merged with Hoechst AG. The merged company was based in Strasbourg, France. Sanofi-Aventis was formed in 2004 when Sanofi-Synthélabo purchased Aventis. as part of our expanded collaboration Working together on a project. See collaborative software. announced in November November: see month. 2002. Our cash balance at March 31, 2003 was $19.3 million and we believe we have sufficient cash to operate the Company beyond fiscal 2005. If a US$10 million milestone payment is received from Aventis at the end of the planned Phase IIa asthma asthma (ăz`mə, ăs`–), chronic inflammatory respiratory disease characterized by periodic attacks of wheezing, shortness of breath, and a tight feeling in the chest. A cough producing sticky mucus is symptomatic. study with IPL512,602 (the results of which are expected in the first half of 2004), these monies would further extend our cash balance. Helicon Collaboration The quarter began with the announcement that Helicon had paid US$250,000 to license one of our PDE4 inhibitors (IPL455,903) for cognitive disorders related to learning and memory. We have established a joint research steering committee steer·ing committee n. A committee that sets agendas and schedules of business, as for a legislative body or other assemblage. steering committee Noun with Helicon, to together plan and oversee the development of the compound, however, Helicon is responsible for all costs incurred in the future development of IPL455,903 through to at least the end of Phase IIa. Up to completion of Phase IIa we have the option to enter into joint development and commercialization of IPL455,903 by taking on one-half of the clinical costs incurred by Helicon to date and to share equally, on a go-forward basis, all costs and profits, beyond Phase IIa. IPL512,602 Clinical Development Importantly in January January: see month. we also announced the opening of an IND for IPL512,602. IPL512,602 is a second generation LSAID(TM) (Leukocyte leukocyte (l `kəsīt'): see blood. leukocyte or white blood cell or white corpuscle Selective Anti-Inflammatory an·ti-in·flam·ma·to·ry or an·ti·in·flam·ma·to·ry adj. Reducing inflammation by acting on body mechanisms. an Drug) being developed as a potential new oral therapy for asthma in collaboration with Aventis. Aventis will supply and fund the clinical resources required to develop this compound. We are on target to commence the Phase IIa asthma study shortly. GlycoDesign Agreement Subsequent to the end of the Quarter, on April 9, 2003, we announced that we had entered into a definitive agreement to acquire GlycoDesign, a Toronto based biopharmaceutical company, which will expand our franchise in inflammation and strengthen our product pipeline. This acquisition will provide us with an opportunity to expand our position as a leader in the development of new LSAIDs by the addition of GlycoDesign's novel CORE 2 inhibitor inhibitor /in·hib·i·tor/ (in-hib´i-tor) 1. any substance that interferes with a chemical reaction, growth, or other biologic activity. 2. program. Importantly it will also expand our clinical stage pipeline with the addition of GlycoDesign's GH9001, a novel anti-thrombotic (anti-blood clotting clotting /clot·ting/ (klot´ing) coagulation (1). clotting the formation of a jellylike substance over the ends or within the walls of a blood vessel, with resultant stoppage of the blood flow. ) therapy, being developed in collaboration with LEO Pharma of Denmark Denmark (dĕn`märk), Dan. Danmark, officially Kingdom of Denmark, kingdom (2005 est. pop. 5,432,000), 16,629 sq mi (43,069 sq km), N Europe. , and currently in Phase I clinical trials Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I . Further, the number of partnering opportunities may also be increased through a combination of both companies' technologies. This acquisition will also strengthen our financial position giving us flexibility to extend our cash through to the end of calendar 2005. The acquisition is subject to approval by GlycoDesign's shareholders and the regulatory authorities Noun 1. regulatory authority - a governmental agency that regulates businesses in the public interest regulatory agency administrative body, administrative unit - a unit with administrative responsibilities . Financial results for the Quarter and Year ended March 31st, 2003 For the financial year ended March 31, 2003, we incurred a loss of $14.7 million ($0.26 per share) compared to a loss of $17.7 million ($0.32 per share) for the prior year, a decrease of $3.0 million. The decrease in the loss was primarily due to lower research and development expenses. Research and development expenses for the year ended March 31, 2003 were $11.2 million compared to $14.8 million in the prior year, a decrease of $3.6 million. The decrease was primarily due to lower contract clinical development expenses. In the prior year the Company incurred costs for a Phase II asthma study, whereas no such expenses were incurred in the current year. The decrease in research and development expenses was partially offset by lower interest income due to lower cash balances and yields during the year compared to the prior year. For the quarter ended March 31, 2003 our loss was $2.2 million ($0.04 per share) compared to $5.4 million ($0.10 per share) for the corresponding quarter of the prior year, a decrease of $3.2 million. The decrease was primarily due to lower contract clinical development expenses. General and administration expenses were also lower for the quarter as a result of capitalizing professional fees associated with the proposed acquisition of GlycoDesign. Your continued support and interest in our Company is much appreciated and I look forward to communicating with you on further progress in the next shareholders letter. Yours sincerely, Ian McBeath, President & CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Inflazyme is a Richmond, B.C., Canada Canada (kăn`ədə), independent nation (2001 pop. 30,007,094), 3,851,787 sq mi (9,976,128 sq km), N North America. Canada occupies all of North America N of the United States (and E of Alaska) except for Greenland and the French islands of based biopharmaceutical company dedicated to the discovery and development of new drug therapies for the treatment of inflammatory disease Noun 1. inflammatory disease - a disease characterized by inflammation disease - an impairment of health or a condition of abnormal functioning NEC, necrotizing enterocolitis - an acute inflammatory disease occurring in the intestines of premature infants; . For more information, please visit http://www.inflazyme.com. Conference Call Inflazyme will host a conference call to discuss this announcement on Monday Monday: see week. , May 12th, 2003 at 1:30 p.m. Pacific time. Audio replay of the conference call will be available two hours following the completion of the call by dialing 416-252-1143 or toll free 1-866-518-1010 until June June: see month. 12th, 2003. Statements in this news release other than historical information are forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Information Form for Inflazyme on file with the Canadian Canadian (kənā`dēən), river, 906 mi (1,458 km) long, rising in NE New Mexico. and flowing E across N Texas and central Oklahoma into the Arkansas River in E Oklahoma. Securities Commissions.
Inflazyme Pharmaceuticals Ltd.
Consolidated Balance Sheets
(Unaudited)
March 31
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2003 2002
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Assets
Current assets
Cash and cash equivalents $ 14,321,664 $ 4,926,266
Short-term investments 5,000,000 30,436,750
Interest receivable 141,380 517,948
Other receivables 47,267 66,887
Prepaid expenses 179,150 214,838
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19,689,461 36,162,689
Deferred acquisition costs 578,977 -
Property and equipment 2,556,839 3,381,003
Other assets 1,510,736 965,781
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$ 24,336,013 $ 40,509,473
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Liabilities
Current liabilities
Accounts payable and accrued
liabilities $ 1,477,492 $ 3,040,580
Current portion of long-term debt 322,055 281,094
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1,799,547 3,321,674
Long-term debt 168,342 490,397
Deferred licensing revenue 383,250 -
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2,351,139 3,812,071
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Shareholders' equity
Capital stock
Issued
Series 1, Class A preference
shares 21,957,676 21,957,676
Common shares 68,848,664 68,842,624
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90,806,340 90,800,300
Deficit (68,821,466) (54,102,898)
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21,984,874 36,697,402
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$ 24,336,013 $ 40,509,473
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On behalf of the board
Ian McBeath (signed)
President & CEO
Graham Wilson (signed)
Director
Inflazyme Pharmaceuticals Ltd.
Consolidated Statements of Operations and Deficit
(Unaudited)
For the Three Months For the Year
Ended March 31 Ended March 31
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2003 2002 2003 2002
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Revenue
Interest $ 133,463 $ 271,051 $ 749,424 $ 1,573,621
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133,463 271,051 749,424 1,573,621
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Expenses
Research
and
development 1,641,097 4,445,481 11,161,585 14,793,303
General and
administration 452,460 930,160 3,305,408 3,504,236
Amortization 254,334 250,211 1,000,999 928,557
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2,347,891 5,625,852 15,467,992 19,226,096
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Loss for
the period (2,214,428) (5,354,801) (14,718,568) (17,652,475)
Deficit,
beginning
of period (66,607,038) (48,748,097) (54,102,898) (36,450,423)
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Deficit,
end of
period $(68,821,466) $(54,102,898) $(68,821,466)$(54,102,898)
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Basic and
diluted
loss per
common
share $ (0.04) $ (0.10) $ (0.26)$ (0.32)
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Weighted-average
number of
common
shares
outstanding 57,550,080 57,547,901 57,550,080 55,774,120
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Inflazyme Pharmaceuticals Ltd.
Consolidated Statements of Cash Flows
(Unaudited)
For the Three Months For the Year
Ended March 31 Ended March 31
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2003 2002 2003 2002
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Cash flows
from
operating
activities
Loss for
the period $ (2,214,428) $ (5,354,801) $(14,718,568)$(17,652,475)
Items not
involving
cash:
-amortization 254,334 250,211 1,000,999 928,557
- non-employee,
stock-based
compensation - - 6,040 -
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(1,960,094) (5,104,590) (13,711,529) (16,723,918)
Changes in
non-cash
working
capital (119,029) 1,024,986 (1,131,212) 1,976,760
Deferred
licensing
revenue 383,250 - 383,250 -
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(1,695,873) (4,079,604) (14,459,491) (14,747,158)
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Cash flows
from
financing
activities
Repayment
of
long-term
debt (73,715) (71,341) (281,094) (229,821)
Common
shares
issued for
cash (net
of issue
costs) - 2,405 - 11,182,289
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(73,715) (68,936) (281,094) 10,952,468
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Cash flows
from
investing
activities
Short-term
investments 6,000,000 63,250 25,436,750 (7,106,288)
Deferred
acquisition
costs (578,977) - (578,977) -
Other
assets (287,268) (11,644) (621,386) (246,570)
Purchase of
property
and
equipment (8,008) (176,020) (100,404) (1,011,994)
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5,125,747 (124,414) 24,135,983 (8,364,852)
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Increase
(decrease)
in cash and
cash
equivalents 3,356,159 (4,272,954) 9,395,398 (12,159,542)
Cash and
cash
equivalents,
beginning
of period 10,965,505 9,199,220 4,926,266 17,085,808
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Cash and
cash
equivalents,
end of
period $ 14,321,664 $ 4,926,266 $ 14,321,664 $ 4,926,266
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Supplemental
disclosure
of cash
flow
information
Interest
paid 17,688 28,088 84,503 120,479
The Toronto Stock Exchange Toronto Stock Exchange (TSE) Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options. has not reviewed and does not accept responsibility for the adequacy or accuracy of this information. |
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