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Overview Jan. 2004: Cash on hand 25 months at current burn (LOM) 13 new clinical trials commenced in 2003 There are 25~30 total trials in the field of which we pay about 25% Currently there are 7 products in the pipeline. Each product is capable of 2 or 3 extra formats such as Home, Professional or Lab If you include the obvious potential spin-offs there are 10.
For example CH123 is 3 products: Tape Test, Wallet Test, Lab test attacking 6 markets: Physicians offices, Insurance testing, Occupational Health, Home Testing, Co- Promotion, Pharmacies
Pipes should hit the market at the rate of 1 or 2 pipes per year in this order:
CH123 PreVu 2004 (Professional) CH123 Tape Test 2004 (Insurance) CH123 Wallet Test 2005 (Home Use) ColorectAlert 2005 (Professional), 2006 (Home Use) LungAlert 2005 (Professional), 2006 (Home Use) BreastAlert 2007 (Professional), 2008 (Home Use) 'CerviXalert' a new unnamed cervical cancer test was alluded too in late 2003
Completed Milestones by timeline:
CH123: Pivotal trials commence November 1997 ColorectAlert: IMI licenses test for detection of early stage colorectal cancer May 1998 ColorectAlert: IMI files patent application for colorectal cancer detection test January 1999 LungAlert: IMI files patent application for lung cancer detection test January 1999 ColorectAlert: Announced May 2000, clinically more accurate than fecal occult blood testing (FOBT) CH123: January 29, 2001, Canadian marketing clearance LungAlert: May 2001 American Thoracic Society, 1st and only early stage test CH123: June 11, 2001 FDA submission CH123: July 10, 2001 DCL agrees to make CH123 CH123: September 5, 2001 SG Cowen Securities hired CH123: October 29, 2001 resubmission to FDA, shares tank to $3.00 CH123: February 25, 2002 Multi-Ethnic Study of Atherosclerosis (MESA 6500 souls) CH123: April 8, 2002 Sprecher breakthrough at American Heart Association ColorectAlert: April 15, 2002 ColorectAlert beats FOBT financially CH123: May 10, 2002 McNeil CDN partnership announced CH123: June 2002 American Journal of Cardiology paper, Mancini CH123: June 24, 2002 FDA approval CH123: Sept. 2002 European approval CH123 @ home: Oct Q4 2002 Unveiling of 2 new modified home tests CH123: Oct. 28th 2002 McNeil demos 123 at the Canadian Cardiovascular Congress, Edmonton CH123: December 2002 signs agreement with McNeil to expand US marketing to the insurance industry, no FDA required CH123: Feb 27th 2003 Revenue commences with Milestone Payment $100,000 CH123: June 2003 Australian Approval CH123: June 2003 Found to be reliable and harmless in testing Pediatric cholesterol D-TECT: Feb 27th 2003 new Coronary Heart Disease Predictor announced SEC Approval: March 12th 2003 clears IMI for a US listing American Association for Cancer Research to publish Cancer Suite Papers, Toronto meeting cancelled due to SARS Apr. 2, 2003 ColorectAlert Trial results announced Apr. 5, 2003 detected 54% early stage colon cancer, 85% accurate clearing non cancer patients LungAlert: Q2 2003, Japanese trial with major Japanese Partner commences LungAlert: Trial results announced Apr. 5, 2003 detected 57% early stage lung cancer, only 10% false positives BreastAlert Apr 03 preliminary trial results encouraging John Hopkins Aug 03; Skin cholesterol is more strongly associated with Arteriosclerosis than blood tests AtheroGenics Aug 03. a $40-million Phase III trial to test 4,000 heart patients uses CH123 Amex Sept 19 2003: IMI begins trading on the American Stock Exchange symbol IME ISO approval achieved Oct. 24th 2003 clearing the way for the launch in Canada of CH123 CH123, D'tect becomes PreVu Nov 10 2003: Skin test helps detect hidden cardiovascular disease 11/10/03
Milestones and News Releases yet to come:
Q3 financials Q1 2004, Revenue stream commences w Canadian launch of PreVu Q1 2004 Milestone payment from McNeil $4 Million Q1 2004 Parke-Davis Phase II Avasimibe Trial results due
Wild Cards 2004/2005: CH123 Pro Test: Announcement of US and World Wide Partners 2004 CH123: Tape Test (Insurance Market), FDA submission 2004, approval 2005 CH123: Home Wallet Test FDA submission 2004, approval 2005 ColorectAlert: Canadian Approval 2004, FDA Submission 2004, approval 2005 LungAlert: Nov. 2003 Joins National Cancer Institute I-ELCAP study to report in 1 year, 2004 LungAlert: Canadian Approval 2004, FDA submission 2004, approval 2005 BreastAlert: expanded trials 2003 -2004 US and EU Development Partners on the Cancer Suite 2005 AtheroGenics Phase III ARISE Trials due 2005 Note: We could enter the US market on ny product w/o FDA through the Lab Testing Marketplace
Marketing foot notes: Cardiovascular disease cost $329 Billion US. 250 Million Cholesterol Tests are performed annually in North America (LOM) Cancer cost $180 Billion US All healthcare $1.4 Trillion US Home testing market is said to reach $2.8 Billion in 2005 61.8 Million Americans have Cardiovascular Disease. 102 Million have elevated Cholesterol. 25 Million people worldwide are on cholesterol reducing medications 11% of the body's cholesterol is in the skin It is estimated that between 500~780 million cholesterol tests are performed annually worldwide. Lungalert, there are 800 million smokers world wide, 100 million in the US and Canada. If the test sells at $25 the revenue potential from only 24 Million smokers is $600,000,000.00 US per year. Breast cancer kills 400,000 women each year worldwide. There were 700,000 mammograms in 2002.
I have archived 10 Research PDF's on IMI starting in 2002 |