Inflazyme Pharmaceuticals Ltd Symbol IZP Shares Issued 57,550,080 Close (2002-11-26) 0.66 Inflazyme releases second quarter results
2002-11-26 20:15 PT - News Release
Mr. Ian McBeath reports
INFLAZYME PHARMACEUTICALS LTD.: QUARTERLY LETTER TO SHAREHOLD ...
During the first six months of fiscal 2003 Inflazyme continued to build on the potential of its LSAIDs technology to be new oral therapies for the treatment of various inflammatory diseases. The company began this fiscal year with promising results from an allergen challenge study with its first generation LSAID, IPL576,092, which supported the potential for LSAIDs to be new asthma treatments. The company then announced the successful completion of its phase Ib study with the second-generation LSAID, IPL512,602, which is now the lead molecule being developed for respiratory disease with the company's partner, Aventis. Finally this month Inflazyme announced the expansion of its collaboration with Aventis.
Under the expanded collaboration, Aventis will now increase its investment in IPL512,602 by taking over all costs and supplying the resources for the development program from this point forward. It may also develop IPL512,602 in a new indication of allergic rhinitis, which would significantly expand the commercial opportunities.
In addition to the expansion of the collaboration around IPL512,602, Inflazyme has also agreed to work with Aventis on the development of another respiratory compound from a new series of LSAIDs, the IPL12 series. These compounds are chemically distinct from IPL512,602 but have demonstrated activity in preclinical models of asthma. If Aventis selects a lead molecule for development from this series, it will take over all costs of developing and commercializing that molecule for respiratory disease. The deal is structured in the same way as for IPL512,602, and thus if successful Inflazyme could earn $45-million (U.S.) in milestones with double-digit royalties on sales. This will be in addition to milestones and royalties for IPL512,602 if both products are developed concurrently and reach the market.
The decision by Aventis to take over the costs for IPL512,602 will reduce the company's cash burn which significantly increases its flexibility to direct resources to the development of its LSAIDs for other, non-respiratory indications with other potential partners. The following tables summarize the company's partnered and unpartnered programs:
PARTNERED PROGRAMS
Aventis agreement (respiratory) IPL512,602 -- asthma and allergic rhinitis IPL12 (series) -- respiratory H1/NK1(series) -- allergic rhinitis Helicon agreement (learning and memory) PDE inhibitors -- enhancement of learning and memory
UNPARTNERED PROGRAMS
IPL550,260 -- inflammation IPL576,092 -- ocular/derm IPL99 (series) -- Inflammation PDE inhibitors -- Inflammation
As the company learns more about its current compounds and continues to discover others, it appears that different compounds demonstrate selectivity for particular leukocytes (white blood cells). This is an important finding which should be represented in the term LSAIDs. Consequently, from now on, in describing LSAIDs the company will refer to leukocyte selective anti-inflammatory drugs rather than leukocyte suppressing anti-inflammatory drugs.
The company finished the second quarter ended Sept. 30, 2002, with $25.9-million in cash and short-term investments. As a result of the expanded collaboration with Aventis, Inflazyme's future financial obligations to the IPL512,602 program are minimized, without reducing its potential milestone or royalty payments. The expansion of the collaboration with Aventis gives the company greater flexibility in extending its cash position and prioritizing its research and development activities. If IPL512,602 is selected by Aventis for further development upon completion of either an asthma or allergic rhinitis phase IIa study, Aventis would make a milestone payment to Inflazyme of $10-million (U.S.).
The net loss for the quarter ended Sept. 30, 2002, was $4.8-million (nine cents per common share) compared with a net loss of $3.7-million (seven cents per common share) in the corresponding quarter of the prior year. The loss for the six months ended Sept. 30, 2002, was $9.5-million (17 cents per common share) compared with $8.1-million (15 cents per common share) for the six months ended Sept. 30, 2001. Lower interest revenue and higher contracted research, related primarily to IPL512,602, accounted for most of the increased net loss.
Inflazyme will host a conference call to discuss its quarterly results on Wednesday, Nov. 27, 2002, at 2 p.m. Eastern Time. Live audio of the conference call will be simultaneously broadcast and made available to members of the news media, investors and the general public via Inflazyme's Web site at www.inflazyme.com. Audio replay of the conference call will be available following the completion of the call via Inflazyme's Web site or by calling 1-888-509-0082 until Dec. 27, 2002.
WARNING: The company relies upon litigation protection for "forward-looking" statements.
CONSOLIDATED STATEMENT OF OPERATIONS AND DEFICIT Three months ended Sept. 30
2002 2001 Revenue
Interest $ 193,984 $ 470,791 ------------ ------------ 193,984 470,791 Expenses
Research and development 3,606,370 3,050,847
General and administration 1,095,846 880,748
Amortization 249,371 228,570 ------------ ------------ 4,951,587 4,160,165 ------------ ------------ (Loss) for the period (4,757,603) (3,689,374)
Deficit, beginning of period (58,894,678) (40,856,945) ------------ ------------ Deficit, end of period $(63,652,281) $(44,546,319) ============ ============ Basic and diluted (loss) per common share $(0.09) $(0.07)
CONSOLIDATED STATEMENT OF OPERATIONS AND DEFICIT Six months ended Sept. 30
2002 2001 Revenue
Interest $ 453,741 $ 975,680 ------------ ------------ 453,741 975,680 Expenses
Research and development 7,453,402 6,822,514
General and administration 2,054,170 1,811,947
Amortization 495,552 437,115 ------------ ------------ 10,003,124 9,071,576 ------------ ------------ (Loss) for the period (9,549,383) (8,095,896)
Deficit, beginning of period (54,102,898) (36,450,423) ------------ ------------ Deficit, end of period $(63,652,281) $(44,546,319) ============ ============ Basic and diluted (loss) per common share $(0.17) $(0.15) |