Inflazyme Pharmaceuticals Ltd. Agrees Plan with FDA for Future Development of Asthma Product, IPL512,602; Also Announces Financial Results for Quarter Ended June 30, 2005.VANCOUVER, British Columbia British Columbia, province (2001 pop. 3,907,738), 366,255 sq mi (948,600 sq km), including 6,976 sq mi (18,068 sq km) of water surface, W Canada. Geography -- 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 ) today announced that it has obtained written feedback from the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. regarding the clinical development of its lead compound, 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, for the treatment of 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. , including the prospective use of patient reported outcomes such as Quality of Life or Symptom symptom /symp·tom/ (simp´tom) any subjective evidence of disease or of a patient's condition, i.e., such evidence as perceived by the patient; a change in a patient's condition indicative of some bodily or mental state. Scores, as primary endpoints for Phase 3 studies. The Company also announced its first quarter financial results for the quarter ended June 30, 2005. Clinical Plan In April 2005, Inflazyme stated its intentions to further advance IPL512,602 for the treatment of asthma, targeting the underlying 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 leading to improved asthma control. In a Phase 2 asthma study completed in the summer of 2004, IPL512,602 demonstrated statistically significant improvements in several of the predefined secondary endpoints that are recognized markers of asthma control including quality of life measures, and decreased need for rescue medication. Inflazyme has been in dialogue with the FDA to understand the acceptability of these endpoints to support efficacy in Phase 3 asthma trials. The Company has now received feedback from the Pulmonary pulmonary /pul·mo·nary/ (pool´mo-nar?e) 1. pertaining to the lungs. 2. pertaining to the pulmonary artery. pul·mo·nar·y adj. Of, relating to, or affecting the lungs. Drug Division of the FDA confirming that the agency would consider the use of quality of life measures and other patient-reported outcomes
A patient-reported outcome or PRO is a questionnaire used in a clinical trial or a clinical setting, where the responses are collected directly from the patient. among the primary endpoints for Phase 3 studies. Quality of life measures used in the initial Phase 2 study are intended to be used in future studies with IPL512,602, and are similar to those employed to support efficacy in pivotal trials with other approved asthma products. Dr. Kevin Mullane, President and 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. of Inflazyme stated "There has been increasing recognition among asthma physicians that there is not a direct correlation Noun 1. direct correlation - a correlation in which large values of one variable are associated with large values of the other and small with small; the correlation coefficient is between 0 and +1 positive correlation between measures of airflow obstruction obstruction /ob·struc·tion/ (ob-struk´shun) 1. the act of blocking or clogging. 2. block; occlusion; the state or condition of being clogged.obstruc´tive ob·struc·tion n. , such as FEV FEV forced expiratory volume. FEV abbr. forced expiratory volume FEV forced expiratory volume. 1 (forced expiratory volume in one second forced expiratory volume in one second (fōrsdˑ ek·spīˑ·r ) and asthma control; with increasing emphasis on the need to control asthma symptoms and improve the quality of life. Consequently, we are very pleased that the FDA recognizes the importance of patient reported outcomes among the endpoints suitable for the development of new asthma products. This supports our clinical strategy for the development of IPL512,602, particularly for disease control and the management of symptoms." The Company is continuing to advance IPL512,602 towards a Phase 2b clinical study, targeted to begin in Q1'2006. The manufacture of drug product will begin this quarter, and the clinical protocol is being finalized See finalization. after a feasibility study "A Feasibility Study" is an episode of the original The Outer Limits television show. It first aired on 13 April, 1964, during the first season. It was remade in 1997 as part of the revived The Outer Limits series with a minor title change. is completed. In addition, the Company is seeking a development and commercialization partner to continue to progress the compound through clinical trials to market. The Company believes that this agreement with the FDA on the clinical strategy going forward will assist in the partnering efforts and helps refine the clinical program. Financial Results for the Quarter Ended June 30, 2005 The Company ended the first quarter with $13.5 million in cash and short term investments down from $15.9 million at March 31, 2005. Cash used in operations of $2.3 million was consistent with the Company's guidance in its shareholder letter of April 15, 2005 and was down from the previous quarter's $2.7 million and significantly less than the $5.6 million for the corresponding quarter last year, reflecting the restructuring restructuring - The transformation from one representation form to another at the same relative abstraction level, while preserving the subject system's external behaviour (functionality and semantics). undertaken last year. The Company remains on track to have two compounds in Phase II in the first half of 2006 as 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., our partner in the development of IPL455,903, continues to progress that compound in learning and memory disorders There are several different types of memory disorders which occur in the human mind. Among these are less severe disorders including minor short term memory loss, and the eventually incapacitating Alzheimer's Disease. and the Company continues the preparation (primarily the manufacture of clinical supplies) for a Phase IIb asthma study with IPL512,602. The Company is seeking a strategic partner to support further development of IPL512,602, beginning with the Phase IIb study. In addition, the Company is seeking to strengthen its financial position through the divestiture The breakup of AT&T. By federal court order, AT&T divested itself on January 1, 1984 of its 23 operating companies, which became known as the Regional Bell Operating Companies (RBOCs). of non-core assets but even without this additional funding the Company believes that its working capital position at June 30, 2005 will enable the Company to fund operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. and capital requirements Capital requirements Financing required for the operation of a business, composed of long-term and working capital plus fixed assets. into the first quarter of calendar 2007. Results of Operations The net loss for the quarter ended June 30, 2005 was $3,063,939 ($0.03 per common share) compared to a net loss of $7,022,774 ($0.07 per common share) in the corresponding quarter in the prior year. The decrease in the loss of $3,958,835 was due to reductions in personnel expenses, laboratory costs and contract research activity. In addition, during the quarter ended June 30, 2004 the Company recorded a write-down Write-Down Reducing the book value of an asset because it is overvalued compared to the market value. Notes: This is usually reflected in the company's income statement as an expense, thereby reducing net income. of $2,335,797 of its acquired intangible assets Intangible Asset An asset that is not physical in nature. Notes: Examples are things like copyrights, patents, intellectual property, and goodwill. These are the opposite of tangible assets. resulting from the termination of the GH9001 clinical development program which was partially offset by a gain of $1,090,354 related to the early termination of a facilities lease. Research and development expenses Research and development expenses for the first quarter ended June 30, 2005 were $1,202,493 versus $2,927,095 during the quarter ended June 30, 2004. The decrease was due to the reduction in personnel expenses through headcount reductions and the resultant This article is about the resultant of polynomials. For the result of adding two or more vectors, see Parallelogram rule. For the technique in organ building, see Resultant (organ). In mathematics, the resultant of two monic polynomials reduction in laboratory activity. Contract research activity was also lower during the first quarter compared to the corresponding quarter last year. In addition, partially offsetting the above decreased costs incurred during the first quarter was the recognition of $63,099 in stock-based compensation. Stock-based compensation of $28,390 was recorded during the first quarter of the prior year. General and administration expenses General and administration expenses for the quarter ended June 30, 2005 were $1,111,910 compared to $1,904,725 for the corresponding quarter of the prior year, a decrease of $792,815. The decrease was due to reduced facilities costs and lower personnel expenses offset by higher professional fees. Also, during the quarter ended June 30, 2005 general and administration related stock-based compensation was $62,732. Stock based compensation of $29,275 was recorded in the corresponding quarter of the prior year. Amortization expenses The Company recorded $852,513 in amortization expense during the quarter ended June 30, 2005 compared to $1,014,103 during the corresponding quarter of the prior year. The amortization amount has decreased due to write-downs in the acquired intangible asset balances taken during fiscal 2005. During May 2004, the Company recorded an impairment Impairment 1. A reduction in a company's stated capital. 2. The total capital that is less than the par value of the company's capital stock. Notes: 1. This is usually reduced because of poorly estimated losses or gains. 2. in the acquired intangible assets balance of $2,335,797 relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the termination of the GH9001 clinical development program. On March 31, 2005 the carrying value Carrying Value Also know as "book value," it is a company's total assets minus intangible assets and liabilities, such as debt. Notes: This is different than market value, as it can be higher or lower depending on the circumstances. of the acquired in-process research and development related to the technology acquired on the acquisition of Adprotech Ltd. in 2004 was written down by $6,010,282 to reflect the estimated fair value of the assets. Liquidity and Capital Resources At June 30, 2005 the Company's cash, cash equivalents 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 totalled $13,518,418 compared to $15,860,738 at March 31, 2005. Working capital at June 30, 2005 was $12,882,462 compared to $15,057,698 at March 31, 2005. The decrease in working capital reflects use of capital resources in the on-going operations of the business. Cash and cash equivalents were $13,306,845 at June 30, 2005 compared to $15,650,334 at March 31, 2005 a decrease of $2,343,489. The decrease in cash and cash equivalents resulted from cash used in financing activities of $24,894, cash used to fund operating activities of $2,267,526 and cash used in investing activities of $51,070. The Company believes that its working capital position at June 30, 2005 will enable the Company to fund operating expenses and capital requirements into the first quarter of calendar 2007. Conference call Inflazyme will host a conference call to discuss this announcement on Monday August 8, 2005 at 9:00 am PDT/12:00 pm EDT EDT abbr. Eastern Daylight Time EDT Eastern Daylight Time EDT n abbr (US) (= Eastern Daylight Time) → hora de verano de Nueva York EDT . To access the call, please dial (416) 695-9753 or 1-800-766-6630. Audio replay of the conference call will be available until September Until September is a 1984 romantic drama set in France. It stars Karen Allen as an American tourist in Paris who falls in love with a married Frenchman (Thierry Lhermitte). External links 8, 2005 by calling (416) 695-5275 or 1-888-509-0081. About Inflazyme Inflazyme is a Vancouver based biopharmaceutical company focused on developing new therapies for the treatment of 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 , inflammation and other related diseases in areas of unmet un·met adj. Not satisfied or fulfilled: unmet demands. medical needs. Further information on the Company may be obtained from its website at www.inflazyme.com. 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
Consolidated Balance Sheets
(Unaudited)
June 30 March 31
2005 2005
-------------- -------------
Assets
Current assets
Cash and cash equivalents $ 13,306,845 $ 15,650,334
Short-term investments 211,573 210,404
Interest receivable 19,758 18,451
Other receivables 84,949 132,988
Prepaid expenses 293,001 346,260
Tax credits recoverable 808,764 1,597,429
-------------- -------------
14,724,889 17,955,866
Property and equipment 2,486,369 2,701,098
Other assets 1,991,777 1,990,828
Acquired intangible assets 7,326,699 7,885,373
-------------- -------------
$ 26,529,735 $ 30,533,165
-------------- -------------
-------------- -------------
Liabilities
Current liabilities
Accounts payable and accrued
liabilities $ 1,814,366 $ 2,845,213
Current portion of long-term
debt 28,061 52,955
-------------- -------------
1,842,427 2,898,168
Deferred licensing revenue 297,020 306,601
-------------- -------------
2,139,446 3,204,768
-------------- -------------
Shareholders' equity
Capital stock
Issued
Preference shares - 21,957,676
Common shares 138,910,033 116,952,357
------------ ------------
138,910,033 138,910,033
Contributed surplus 1,507,571 1,381,739
Deficit (116,027,314) (112,963,375)
-------------- -------------
24,390,290 27,328,397
-------------- -------------
$ 26,529,736 $ 30,533,165
-------------- -------------
-------------- -------------
On behalf of the board
Kevin Mullane (signed) Graham Wilson (signed)
President and CEO Director
Director
Inflazyme Pharmaceuticals Ltd.
Consolidated Statements of Operations and Deficit
(Unaudited)
For the Three Months Ended
----------------------------------
June 30, 2005 June 30, 2004
----------------------------------
Revenues
Interest $ 93,396 $ 166,987
Licensing revenue 9,581 9,581
----------------------------------
102,977 176,568
----------------------------------
Expenses
Research and development 1,202,493 2,927,095
General and administration 1,111,910 1,904,725
Amortization 852,513 1,014,103
Write-down of acquired
intangible assets - 2,335,797
Write-downs and loss on
disposal - 107,976
(Gain) / Loss on lease
termination - (1,090,354)
----------------------------------
Total expenses 3,166,916 7,199,342
----------------------------------
Loss for the period (3,063,939) (7,022,774)
Deficit, beginning of period (112,963,375) (84,855,701)
----------------------------------
Deficit, end of period $ (116,027,314) $ (91,878,475)
----------------------------------
----------------------------------
Basic and diluted loss per
common share (0.03) (0.07)
----------------------------------
----------------------------------
Weighted average number of
common shares outstanding 106,676,361 103,427,446
----------------------------------
----------------------------------
Inflazyme Pharmaceuticals Ltd.
Consolidated Statements of Cash Flows
(Unaudited)
For the Three Months Ended
----------------------------------
June 30, 2005 June 30, 2004
----------------------------------
Cash flows from operating
activities
Loss for the period $ (3,063,939) $ (7,022,774)
Items not affecting cash:
Amortization 852,513 1,014,103
Write-downs and loss on
disposal - 107,976
Write-down of acquired
intangible assets - 2,335,797
Deferred licensing revenue (9,581) (9,580)
Gain on reversal of lease
liability - (1,090,354)
Change in lease liability - (54,519)
Stock-based compensation 125,832 57,665
----------------------------------
(2,095,175) (4,661,686)
Changes in non-cash working
capital (172,351) (921,528)
----------------------------------
(2,267,526) (5,583,214)
Cash flows from financing
activities
Repayment of long-term debt (24,894) (144,562)
----------------------------------
(24,894) (144,562)
----------------------------------
Cash flows from investing
activities
Short-term investments 1,169 452,498
Cash from the acquisition of
Adprotech - 7,345,991
Acquisition costs - Adprotech - (582,258)
Other assets (46,408) (67,330)
Purchase of property and
equipment (5,831) (82,592)
----------------------------------
(51,070) 7,066,309
----------------------------------
Increase (decrease) in cash
and cash equivalents (2,343,489) 1,338,533
Cash and cash equivalents,
beginning of period 15,650,334 27,375,085
----------------------------------
Cash and cash equivalents,
end of period $ 13,306,845 $ 28,713,618
----------------------------------
----------------------------------
Supplemental disclosure of
cash flow information
Interest paid 9,159 10,263
Interest received 93,396 166,987
Issuance of common shares on
conversion of Series 1,
Class A preference
shares 21,957,676 -
Issuance of common shares on
the acquisition of Adprotech
Limited net assets - 19,533,445
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. Inflazyme Pharmaceuticals Ltd. (TSX:IZP) |
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