Mike Rabe, a biotech research analyst, discusses Biomoda, Inc. (OTCBB: BMOD). Mike describes Biomoda as a largely undiscovered cancer diagnostics biotech company that he believes will soundly beat the market in 2010. Below please find Mike’s complete analysis.
Biomoda is an Albuquerque, New Mexico-based cancer diagnostics company. Their mission is to save lives by making the early diagnosis of the deadliest cancers available at an affordable cost to large populations worldwide.
The company’s early cancer detection assay came from a spin-off of the Los Alamos National Labs through a licensing and cooperative development agreement. The company then licensed the the original patents and now has their own patent portfolio which they plan to expand into early detection assays for multiple cancer detection applications.
Biomoda’s Cypath® diagnostics technology is approximately two weeks from completing its Phase II studies for lung cancer patients.
Company CEO, John Cousins tells BioMedReports that early data from the studies shows that primary endpoints in the “high risk” group have been exceeded. Now, researchers are gathering comparison data for their “positive controls.” The seek to find statistical significance showing a minimum of at leat 80% accuracy in the technology’s readings.
The end of these Phase II studies will mark another important milestone for the company since they will be able to submit the completed Phase II data to European regulators in hopes of being granted a CE Mark. If successful, it would certify that Biomoda’s Cypath® has met EU consumer safety and health requirements and open the door for the company to begin commercializing the product throughout Europe by the middle of this year. The market potential for the assay is more than twice as large as it is in North America.
With an estimated 90 million smokers in the U.S., and 215 million in Europe, health officials say there is a serious need for advanced, early detection lung cancer diagnostics technology.
Since lung cancer continues to be the leading cause of cancer death in the U.S, the company will simultaneously begin Phase III trials at multiple locations throughout the U.S. After those trials conclude, it hopes to submit an application for approval to the FDA as a Class III PMA IVO device. Decisions for such devices are usually given within 9 months.
Interestingly, the Phase II studies were not funded at stock holders’ expense, but by the New Mexico State Legislature from the state’s tobacco settlement funds. Biomoda recruited at-risk military veterans for the trials and the program was screened and administered by the New Mexico Department of Veterans Services (NMDVS) and the New Mexico Institute of Mining and Technology (NM Tech).
Biomoda’s technology platform is based on Tetrakis Carboxy Phenyl Porphine (TCPP), which is a porphyrin that binds to cancer cells. Porphyrins are naturally occurring pigments that fluoresce red when exposed to UV light. This creates a very accurate diagnostics test. The technology is scalable and easy to automate. This means large populations can be screened at affordable costs.
Biomoda also plans to test and commercialize an entire portfolio of early cancer diagnostics diagnostics tools, based on the same technology, for deadly breast, oral, prostate, bladder, colorectal, and cervical cancers.
Biomoda’s stock (OTC:BMOD) is currently undervalued, but all of these pending developments present opportunities for a significant capital appreciation in the stock price. Excellent Phase II results will certainly re-rate the stock.
Investors have the stock trading higher in anticipation of these upcoming milestones, but the share float is very tight and a breakout beyond the previous 52-week high of $.37 could signal a strong push upward.
Article published courtesy of BioMed Reports, http://biomedreports.com/.
What a great company. Early diagnosis is SO important.