The
stock research section of BioMedReports.com has been updated on 8/14/09 to reflect new developments following the 2Q09 conference call and business update for EXACT Sciences (NASDAQ:
) as the Company prepares for a Phase 3 study next year to obtain FDA marketing clearance for its next-generation stool DNA (sDNA) screening test (V3) for colorectal cancer (CRC) and pre-cancers. The following is a summary of the highlights, projections, and expected milestones from my updated report for EXAS.
1.) Financial Metrics: About 35 million fully diluted shares outstanding, $27.8 million cash/equivalents, zero debt and the CEO has guided for no capital raise within the next 12 months and an ongoing goal of maintaining at least $10 million in capital at all times. Expected modest dilution (5 million shares sold at much higher prices) for about 40 million shares outstanding at the time of expected FDA marketing clearance and U.S. launch in mid-2011 (3Q11) to support commercialization.
2.) U.S. commercial strategy will involve direct licensing of a FDA-cleared V3 test kit to major labs throughout the country at an estimated royalty of 20% ($30/test based on $150 pricing model) through an in-house sales team
3.) Announced appointment of Graham P. Lidgard, Ph.D., as Chief Scientific Officer (CSO) on 8/3/09 to assist with product development and regulatory affairs. Dr. Lidgard has over three decades of clinical/molecular diagnostics experience and a successful track record of preparing and obtaining FDA marketing clearance for 510(k) and PMA submissions as he previously led the R&D organization at Gen-Probe (NASDAQ:GPRO) that developed that Company's Procleix blood-screening and Aptima sexually-transmitted disease products (which generated over $400 million in revenues during 2008.
4.) Pending Phase 3 FDA study is likely to be much smaller in scale (3,000 subjects) versus the previous guidance of 8,000-10,000 subjects enrolled at 30-40 clinical sites that would have taken 12-18 months to complete. Goal of this study is to obtain broad claims and FDA marketing clearance for a non-invasive stool DNA based colorectal cancer (CRC) screening test, including the detection of pre-cancers. Projected start of a 3,000 patient study during 2Q10 after product development is concluded (along with extensive input from the recently appointed CSO) with results in about six months during 4Q10 at an estimated cost of about $5 million with results and FDA submission expected in early 2011. FDA marketing clearance and U.S.
