On 11/3/09, EXACT Sciences (NASDAQ:
EXAS) reported its 3Q09 results and held a conference call to outline the Company's progress and timeline for the development of a stool DNA based test kit for the early diagnosis and prevention of colorectal cancer (CRC). EXAS reported total revenue of $1.3 million (which primarily reflects non-cash recognition of Genzyme deal earlier this year), a net loss of $1 million, operating expenses of $2.3 million, and ended the quarter with cash / equivalents of $26.9 million
Last week, EXAS made a SEC 8-K filing regarding its President / CEO, Kevin T. Conroy, who is considering a run for Governor of Wisconsin in 2010. Mr. Conroy stated on the call today that a succession plan is premature at this point, and he plans to make a decision in the very near future on whether to make the run for governor (this would be communicated in the form of another SEC 8-K filing) - indicating that he is only considering such a move because of confidence in the strong team that is already in place at EXAS.
In March, EXAS conducted a management overhaul that included Mr. Conroy and CFO Maneesh Arora, following their successful tenure at Third Wave Technologies. In early August, EXAS announced the appointment of Graham P. Lidgard, Ph.D., as Chief Scientific Officer, who 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 that includes leading the R&D organization at Gen-Probe (NASDAQ: GPRO). Other key collaborations include the Mayo Clinic (Dr. David Ahlquist), Johns Hopkins (Dr. Bert Vogelstein), Genzyme (NASDAQ: GENZ), Case Western Reserve (Dr. Sandy Markowitz).
A summary of the conference call and upcoming milestones for EXAS includes the following:
1.) Data is expected by 3Q10 to provide external validation of the Company's stool DNA based CRC test kit.
2.) A clinical trial to support marketing clearance of the CRC test kit from the FDA is expected to begin during 2-3Q11. EXAS expects total costs of approximately $15-20 million for the FDA study, which will involve 20-30 sites.
3.) A submission to the FDA for marketing clearance is expected during 2012 via the 510(k) de novo route (since no predicate device exists with FDA marketing clearance). EXAS has received extensive input from the FDA for the design of this clinical trial and will remain in close contact with the Agency, following the same model of success applied at Third Wave for that Company's HPV test.
4.) EXAS provided guidance for an average cash burn rate of about $1 million per month during 2010, which is expected to increase slightly as the Company continues to expand and adds additional personnel.
