Inflazyme Pharmaceuticals Ltd.: Letter to Shareholders for the Quarter Ended December 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)--Feb. 25, 2004 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: During the quarter ended December December: see month. 31, 2003, we continued to make good progress. Our 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 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, being executed by our partner 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. , is proceeding as planned. We commenced this study in May 2003, and this month enrollment for the study was completed. We remain on track to report the results of oral IPL512,602 in mild to moderate asthmatic patients during the summer of 2004. In November November: see month. 2003, we commenced Phase Ib multi-dose clinical safety studies with our anti-thrombotic, GH9001; a combination medium molecular weight heparin heparin (hĕp`ərĭn), anticoagulant produced by cells in many animals. A polysaccharide, heparin is found in the human body and occurs in greatest concentration in the tissues surrounding the capillaries of the lungs and the liver. and low molecular weight dermatan sulphate sulphate: see sulfate. . GH9001 is to be developed for the prevention of thrombotic thrombotic /throm·bot·ic/ (-bot´ik) pertaining to or affected with thrombosis. throm·bot·ic adj. Relating to, caused by, or characterized by thrombosis. complications associated with peripheral arterial arterial /ar·te·ri·al/ (-al) pertaining to an artery or to the arteries. ar·te·ri·al adj. 1. Of or relating to one or more arteries or to the entire system of arteries. 2. bypass graft bypass graft Surgery A surrogate blood vessel used to reroute blood; BGs may be synthetic–Dacron, or autologous–vein from the Pt's own leg, to substitute for diseased vessel surgery. We ended the quarter with cash and short-term Short-term Any investments with a maturity of one year or less. short-term 1. Of or relating to a gain or loss on the value of an asset that has been held less than a specified period of time. investments of $32.1 million. Our cash reserves Cash reserves See: Cash investments cash reserves Investment funds that are held in short-term assets such as Treasury bills and certificates of deposit until more permanent investment opportunities are available. were strengthened through the $15 million (less offering related expenses) bought deal financing that was completed November 25, 2003. We believe, through the addition of this cash, we will be able to fund operations beyond fiscal 2006. Our Phase IIa Asthma Study As you may be aware, the Phase IIa study for the treatment of asthma with IPL512,602 began in May 2003. The study is a twelve week, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , double-blind double blind n. A testing procedure, designed to eliminate biased results, in which the identity of those receiving a test treatment is concealed from both administrators and subjects until after the study is completed. , parallel group trial comparing the safety, tolerability tol·er·a·ble adj. 1. Capable of being tolerated; endurable. 2. Fairly good; passable. See Synonyms at average. tol and efficacy of IPL512,602 to placebo placebo (pləsē`bō), inert substance given instead of a potent drug. Placebo medications are sometimes prescribed when a drug is not really needed or when one would not be appropriate because they make patients feel well taken care of. in male patients with mild to moderate, persistent asthma. The dose is administered daily, and in oral form. Approximately 160 patients have been enrolled in more than 20 centers across the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . The study is on track to complete in 12 to 15 months from when it started. The study is being conducted by our partner Aventis, who are providing all resources and paying for all costs associated with the execution and completion of this study. Given a successful outcome of this study, Aventis may pay Inflazyme a milestone of US$10 million and assume responsibility for the remainder of clinical development and subsequent commercialization of the product. Inflazyme may receive a further US$35 million in milestone payments and double-digit dou·ble-dig·it adj. Being between 10 and 99 percent: double-digit inflation. royalties on net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight , once the product is commercialized. Our Phase Ib with GH9001 for the treatment of Peripheral Arterial Bypass Surgery Bypass surgery A surgical procedure that grafts blood vessels onto arteries to reroute the blood flow around blockages in the arteries (arteriosclerosis). On November 3, 2003, we initiated a Phase Ib study with GH9001. The Phase Ib study is a double-blind, multi dose study in healthy volunteers. In the first part of the study, subjects will receive GH9001 subcutaneously sub·cu·ta·ne·ous adj. Located or placed just beneath the skin: subcutaneous tissue; a subcutaneous implant. sub twice daily for four days, and a single dose on the fifth day. In the second part of the study, dosing will be extended to 14 days. The study is designed to assess the safety and tolerability of the compound together with surrogate markers A surrogate marker (or surrogate end point) is term used in medical research for a change to the human body that is believe to be necessary to an eventual outcome or end point. of activity on measures of blood clotting blood clotting, process by which the blood coagulates to form solid masses, or clots. In minor injuries, small oval bodies called platelets, or thrombocytes, tend to collect and form plugs in blood vessel openings. . Financial Results for the Third Quarter Ended December 31, 2003 At December 31, 2003, we had cash and short-term investments of $32.1 million. Our cash position was strengthened through the $15 million (less offering related expenses) bought deal financing that was completed November 25, 2003. We believe this additional injection of cash allows us to continue to fund our operations beyond fiscal 2006. For the quarter ended December 31, 2003 our net loss was $3.8 million ($0.05 per share) compared to a net loss of $2.9 million ($0.05 per share) for the corresponding quarter of the prior year. The increase in the net loss of just under $0.9 million for the quarter was due to higher research and development, general and administration, and amortization expenses in the current quarter compared to the three months ended December 31, 2002. The net loss for the nine months ended December 31, 2003 was $11.1 million ($0.15 per common share) compared to $12.5 million ($0.22 per common share) for the nine months ended December 31, 2002. The decrease in the loss of $1.4 million for the nine month period was primarily due to lower research and development expenses partially offset by higher general and administration expenses and higher amortization expenses in the current nine-month period compared to the corresponding period ended December 31, 2002. Thank you for your continued interest in our Company. 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 Vancouver Vancouver, city, Canada Vancouver, city (1991 pop. 471,844), SW British Columbia, Canada, on Burrard Inlet of the Strait of Georgia, opposite Vancouver Island and just N of the Wash. border. based biopharmaceutical company focused on developing new therapies for the treatment of 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 , thrombosis thrombosis (thrŏmbō`sĭs), obstruction of an artery or vein by a blood clot (thrombus). Arterial thrombosis is generally more serious because the supply of oxygen and nutrition to an area of the body is halted. and other related diseases. Further information on the Company may be obtained from its website at www.inflazyme.com. Conference Call Inflazyme will host a conference call to discuss this announcement on Thursday, February 26th, 2004 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 416-695-5275 or toll free 1-866-518-1010 until March 26th, 2004. 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)
December 31 March 31
2003 2003
-----------------------------
Assets
Current assets
Cash and cash equivalents $ 10,713,356 $ 14,321,664
Short-term investments 21,411,598 5,000,000
Interest receivable 84,379 141,380
Other receivables 361,493 47,267
Prepaid expenses 442,875 179,150
Tax credits recoverable 794,675 -
-----------------------------
33,808,376 19,689,461
Assets held for sale 341,018 -
Deferred acquisition costs - 578,977
Property and equipment 3,481,907 2,556,839
Other assets 1,694,500 1,510,736
Acquired intangible assets 5,156,074 -
-----------------------------
$ 44,481,875 $ 24,336,013
-----------------------------
-----------------------------
Liabilities
Current liabilities
Accounts payable and accrued
liabilities $ 2,255,810 $ 1,477,492
Current portion of lease
liability 320,514 -
Current portion of long-term debt 931,089 322,055
-----------------------------
3,507,413 1,799,547
Lease liability 987,914 -
Long-term debt 87,357 168,342
Deferred licensing revenue 354,506 383,250
-----------------------------
4,937,190 2,351,139
-----------------------------
Shareholders' equity
Capital stock
Issued
Series 1, Class A preference
shares 21,957,676 21,957,676
Common shares 97,423,410 68,848,664
-----------------------------
119,381,086 90,806,340
Contributed surplus 140,086 -
Deficit (79,976,487) (68,821,466)
-----------------------------
39,544,685 21,984,874
-----------------------------
$ 44,481,875 $ 24,336,013
-----------------------------
-----------------------------
On behalf of the board
Ian McBeath (signed) Graham Wilson (signed)
President & CEO Director
Director
Inflazyme Pharmaceuticals Ltd.
Consolidated Statements of Operations and Deficit (Unaudited)
For the For the
Three Months Ended Nine Months Ended
December 31 December 31
-----------------------------------------------------
2003 2002 2003 2002
-----------------------------------------------------
Revenue
Interest $ 165,667 $ 162,220 $ 482,164 $ 615,961
Licensing
revenue 9,581 - 63,649 -
-----------------------------------------------------
175,248 162,220 545,813 615,961
-----------------------------------------------------
Expenses
Research and
development 2,363,954 2,067,086 6,381,502 9,520,488
General and
administration 985,855 798,778 3,715,950 2,852,948
Amortization 611,267 251,113 1,603,382 746,665
-----------------------------------------------------
3,961,076 3,116,977 11,700,834 13,120,101
-----------------------------------------------------
Loss for the
period $ (3,785,828) $ (2,954,757) $(11,155,021) $(12,504,140)
Deficit,
beginning of
period (76,190,659) (63,652,281) (68,821,466) (54,102,898)
-----------------------------------------------------
Deficit, end
of period $(79,976,487) $(66,607,038) $(79,976,487) $(66,607,038)
-----------------------------------------------------
-----------------------------------------------------
Basic and
diluted
loss
per common
share $ (0.05) $ (0.05) $ (0.15) $ (0.22)
-----------------------------------------------------
-----------------------------------------------------
Weighted-average
number of
common shares
outstanding 85,140,946 57,550,080 76,171,158 57,550,080
-----------------------------------------------------
-----------------------------------------------------
Inflazyme Pharmaceuticals Ltd.
Consolidated Statements of Cash Flows
(Unaudited)
For the For the
Three Months Ended Nine Months Ended
December 31 December 31
-----------------------------------------------------
2003 2002 2003 2002
-----------------------------------------------------
Cash flows from
operating
activities
Loss for the
period $ (3,785,828) $ (2,954,757) $(11,155,021) $(12,504,140)
Items not
involving
cash:
Amortization 611,267 251,113 1,603,382 746,665
Deferred
licensing
revenue (9,582) - (28,744) -
Loss on
disposal of
property and
equipment 324 - 51,752 -
Change in
lease
liability (54,518) - (109,036) -
Stock-based
compensation - 6,040 - 6,040
-----------------------------------------------------
(3,238,337) (2,697,604) (9,637,667) (11,751,435)
Changes in
non-cash
working
capital (195,467) (961,443) (1,350,161) (1,012,183)
-----------------------------------------------------
(3,433,804) (3,659,047) (10,987,828) (12,763,618)
-----------------------------------------------------
Cash flows
from
financing
activities
Repayment of
long-term
debt (267,799) (71,368) (608,520) (207,379)
Common shares
issued for
cash 15,132,002 - 15,228,842 -
Cost of
common share
issuances (1,491,679) - (1,578,750) -
-----------------------------------------------------
13,372,524 (71,368) 13,041,572 (207,379)
-----------------------------------------------------
Cash flows
from
investing
activities
Short-term
investments (21,411,598) 1,000,000 (16,411,598) 19,436,750
Disposal of
assets held
for sale - - 23,880 -
Cash from the
acquisition
of GlycoDesign
Inc. - - 12,852,187 -
Acquisition
costs - - (1,741,475) -
Other assets (155,471) (244,262) (270,550) (334,118)
Purchase of
property
and
equipment (60,651) (9,632) (114,496) (92,396)
-----------------------------------------------------
(21,627,720) 746,106 (5,662,052) 19,010,236
-----------------------------------------------------
Increase
(decrease)
in cash and
cash
equivalents (11,689,000) (2,984,309) (3,608,308) 6,039,239
Cash and cash
equivalents,
beginning of
period 22,402,356 13,949,814 14,321,664 4,926,266
-----------------------------------------------------
Cash and
cash
equivalents,
end of
period $ 10,713,356 $ 10,965,505 $ 10,713,356 $ 10,965,505
-----------------------------------------------------
-----------------------------------------------------
Supplemental
disclosure of
cash flow
information
Stock-based
compensation - 6,040 - 6,040
Interest paid 27,579 20,029 82,487 66,815
Issuance of
common shares
and grant of
stock options
on the
acquisition of
GlycoDesign
Inc. net assets - - 15,064,740 -
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. |
|
||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion