Micrologix Biotech Inc -
Micrologix Biotech 1999 third quarter report
Micrologix Biotech Inc MBI Shares issued 23,058,599 1999-04-23 close $2.5 Monday Apr 26 1999 Mr. Dany Hadary reviews the company On Dec. 1, 1998, the company announced the start of a phase I human clinical trial in the United States of MBI 226, its lead antimicrobial peptide for the prevention of bloodstream infections in patients undergoing central venous catheterization. The phase I study is a randomized, double-blind, placebo-controlled trial in 18 healthy volunteers to assess the safety, tolerability and antimicrobial effect of MBI 226. Micrologix plans to announce the phase I results in late April and to start a phase II trial in the second half of 1999. Bloodstream infections resulting from intravenous catheters are a serious medical problem. Approximately 3.5 million central venous catheters are placed in patients in U.S. hospitals each year. The Centers for Disease Control and Prevention in Atlanta, Ga., estimate that 250,000 hospitalized patients contract bloodstream infections each year in the U.S. These infections most commonly derive from the use of invasive devices such as intravenous catheters. More than 90 per cent of the catheter related infections are caused by central venous catheters and result in the death of up to 50,000 patients annually and an additional two million patient-days in intensive care units at an estimated annual cost of $7-billion. Plans to Start Clinical Trials for the Treatment of Acne Micrologix's Bactolysins offer significant potential for the effective treatment of severe acne. Results from our preclinical research program demonstrate that Bactolysins are non-toxic and non-irritating in animal models. In addition, the superior activity of Bactolysins against resistant strains of acne-causing bacteria suggests that our drug candidates may be more effective in treating acne than currently available in antibiotics. Most importantly, unlike conventional antibiotics, Bactolysins kill microorganisms such as bacteria by destroying their cellular membranes, thus preventing bacteria from developing resistance to them. For these reasons, Bactolysins are considered to be strong drug candidates for the treatment of severe inflammatory acne. Acne is the most common skin disease of adolescence and early adulthood. Nearly 20 per cent of all visits to dermatologists are related to the evaluation and treatment of acne. While not life-threatening, the characteristic papules, nodules and pustules occurring on the face, neck and upper body of acne sufferers can persist for years and have serious adverse psychosocial effects including depression and withdrawal from society. by conservative estimates, acne affects 17 millon people in the U.S. alone. The U.S. market for prescriptin anti-acne medications is approximately $1.2-billion annually. Current therapy for severe acne includes topical antibiotics and the use of systemic antibiotics approved for other indications. Yet, increasing resistance to these antibiotics is severly limiting their use. The company is proceeding with additional preclinical testing of several of its lead Bactolysins and plans to start clinical trials in the first quarter of 2000. Expanding Product Line - Further Indications Targetted for Development In addition to central venous catheters related bloodstream infections and acne the company plans to enter clinical trials for a third undisclosed indication in the first half of 2000. Further drug candidates are being screened and developed for other clinical indications including the treatment of ocular infections. Financial Highlights Financial results for the nine months ended Jan. 31, 1999, showed a net loss of $4,730,150 or 21 cents per share, compared with a net loss of $3,559,221 or 15 cents per share for the nine months ended Jan. 31, 1998. Total expenses were $5,230,783 for the period compared with $4,160,978 in 1998, an increase of 26 per cent. This increase is due primarily to the commitment of resources to the company's research and development programs including preclinical and clinical studies of MBI 226 for the prevention of blood stream infections in catheterized patients. Research and development expenses increased 49 per cent to $3,737,870 for the period, compared with $2,512,826 in 1998. General and corporate expenses were $1,492,913 for the period compared with $1,648,152 in 1998, a drecrease of 9 per cent. Revenues were $500,633, a decrease of 17 per cent compared with 1998, due principally to lower cash balances. At Jan. 31, 1999, the company's cash and marketable securities were $12,223,950, a decrease of $5,044,690 from April 30, 1998. This decrease is comprised of $4,325,056 used to finance operating activities and $719,634 in capital expenditures.
CONSOLIDATED STATEMENTS OF OPERATIONS AND DEFICIT Three months ended Jan. 31
1999 1998
Revenue
Interest and sundry $ 149,302 198,584
Expenses
Research and development 1,252,827 1,021,124
General and corporate 507,386 552,325 ---------- --------- 1,760,213 1,573,449 ---------- ---------
Net loss 1,610,911 1,374,865
Deficit - beginning of period 17,553,357 11,237,219
Deficit - end of period $19,164,268 12,612,084 =========== ========== Net loss per share 7 cents 6 cents
CONSOLIDATED STATEMENTS OF OPERATIONS AND DEFICIT Nine months ended Jan. 31
1999 1998
Revenue
Interest and sundry $ 500,633 601,757
Expenses
Research and development 3,737,870 2,512,826
General and corporate 1,492,913 1,648,152 ---------- --------- 5,230,783 4,160,978 ---------- ---------
Net loss 4,730,150 3,559,221
Deficit - beginning of period 14,434,118 9,052,863
Deficit - end of period $19,164,268 12,612,084 =========== ========== Net loss per share 21 cents 15 cents
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