Continuing from Part 1 here are some specific comments on interesting companies.
Adeona Pharmaceuticals (AEN) Amex ($0.83) Market Cap $19M, $25M Sh. Outstanding
Adeona is a development stage drug Company focused in CNS that in -licenses clinical stage product candidates that are ready to be “tested in humans”. The pipeline is quite diverse with five product candidates: Trimesta for MS, Effirma for fibromyalgia, Zinthionein ZC for Alzheimer Disease (AD)-a prescription medical food, dnaJP1 for RA, and Zinc MonoCysteine for dry age-related macro degeneration.The Company achieved $980k in Q2 income with Revenues from licensing of $2,195k and CLIA Lab Revenues of $2,255K. The Company has $3.3M in cash and has significant grant funding.
The Company has a strategic partnership with MEDA a Swedish drug Company for fibromyalgia with potential milestones of $15M. The CLIA Lab is focused in Microbiology and pediatric testing and a unique CopperProof Panel Test for Zinc and Copper levels. The Company believes that copper toxicity is responsible for cognitive decline and implicated in AD and is seeking data to show that Zinthionein ZC can be prescribed as a medical food.
Exact Sciences (EXAS) NASDAQ ($6.40), Market Cap $258.6 , 40.3M sh. Outstanding
Exact Sciences is a molecular diagnostic Company focused on the early detection and prevention of colorectal cancer.A third generation proprietary test currently in development is based upon stool -based DNA (sDNA) that is combined with an older test FIT, a blood protein test. The goal of the 3rd Gen product is a patient friendly test that is non-invasive and provides improved specificity (>90%) and sensitivity (>50%) over current tests. The molecular test platform utilizes methylated vimentin biomarkers in a PCR and Invader platform (licensed from Hologic). Some of the biomarkers are exclusively licensed from OncoMethylome Sciences. The CEO of EXAS, Kevin Conroy , was previously the CEO of Third Wave which was sold to Hologic (HOLX). The Invader platform was used for the detection OF HPV and is a marketing model for the adoption of sDNA testing.
Nine biomarkers are being targeted in the validation study with the goal of picking the 3-4 which provide the best results. The validation data will be presented on October 28/29 and would provide the basis for a $15-20M clinical study. The trial should be completed by Q3 2011 with an FDA submission in the 2012 timeframe. The Company plans to launch its test as a “home brew” or CLIA Lab Test (LDT) prior to gaining broad FDA approval.
The market potential based upon a target population of 100M is $1.2B. About $12B is currently being spent on colonoscopy but 50% have never been screened. Colonoscopy is considered an invasive,expensive,uncomfortable procedure and it is expected that the 3rd Gen test will be used in conjunction with colonoscopy.
On August 17 the Company filed a shelf offering for offer or sale of $150M in securities.As of June 30 the Company had $37M in cash, and $1.3M in revenue. The stock has almost doubled from the mid-July level so investors are expecting excellent results from the clinical validation study on October 27.
Exact Sciences (EXAS)