Setting the Stage for Growth - C.E.O.'s Blog Update
Q1: Setting the stage for growth in 2013
Technology and management ultimately dictate the success of any biotechnology venture. After the initial discovery work performed by Amarantus’ Chief Scientific Officer Dr. John W. Commissiong, our patented MANF technology has been validated by independent researchers from around the world, leading to over two dozen peer-reviewed publications. Even more encouraging is that MANF’s mechanism of action appears to lend itself to addressing a range of potential therapeutic applications with large market opportunities addressing significant unmet medical currently under evaluation. With this opportunity in our midst, my responsibility as CEO is to position the Company to actualize its potential by removing barriers to progress and establishing a credible plan that gives our shareholders and the broader investment community confidence that we will meet our objectives. In this vein, we are making solid progress in the first quarter by:
Streamlining our financial structure: As many development-stage companies born in the chaos of 2008, we suffered through financial hardship while we worked to establish proof-of-concept for MANF in Parkinson’s disease. Since that time, we have taken concrete steps to clean-up our balance sheet, a critical move to fund the further development of MANF and our diagnostic platforms. In the last two weeks, the Company has retired a number of potentially problematic notes, warrants and legal challenges that would have otherwise impeded our continued development, and makes us a much healthier company.
Spinning off Amarantus Diagnostics: Last week we disclosed the creation of Amarantus Diagnostics, a subsidiary company to further develop the Company’s LymPro and NuroPro diagnostic assets. The internal estimates of the market opportunity for these assets exceeds $800 million and the time to market is likely significantly less than our MANF asset, due to different regulatory requirements for marketing of these types of diagnostics. Moreover, with recent guidance from the FDA regarding the need to focus drug development programs on early-stage patients, Amarantus Diagnostics will be positioned among the most innovative companies developing products in the Alzheimer’s space with LymPro. From the corporate perspective, we believe we can unlock the true value of these assets without further diluting the value of the MANF opportunity for our shareholders with this strategy. We are currently working on updating the clinical trial design for the LymPro and NuroPro assets in light of recent developments in the field and will update the marketplace in the near future regarding timelines to key milestones on their path to commercialization. At that time, we will also address how our shareholders will benefit from the spinoff.
MANF entering the eye of the storm: 2013 has been characterized by many in our industry as the year of the growth factor in Parkinson’s Disease. For those who do not know the history, several hundred million dollars were spent in the 1990’s and early 2000’s researching the translation of certain neurotrophic factors into new treatments for patients. While those efforts ended in failure, the knowledge gained from those endeavors, particularly as it relates to delivery of therapeutics to the brain, has shaped a new wave of growth factor treatments currently in development. Amarantus owns the patent rights to both protein therapy and gene therapy for MANF in all neurological indications including Parkinson’s, uniquely positioning the Company from an intellectual property standpoint. What’s more, MANF’s ability to cause re-innervation of the striatum with nigral delivery separates it as a best-in-class molecule from a mechanism standpoint. In the coming months, we expect other biotech companies to announce clinical data outcomes on biological approaches, and we believe this will result in increased interest in the field overall. We view this as a very significant benefit to Amarantus, and we are positioning ourselves to capitalize on the increased focus these trial results will bring with them.
Management is working closely with our Board of Advisors to finalize the product development plans for MANF and deliver key timelines and milestones on the road to an IND filing for MANF in Parkinson’s disease and we will update the marketplace in this regard once the planning has been finalized. We believe that significant milestones will be achievable in parallel as the Company generates additional data on other indications for MANF, with a specific focus on orphan diseases. Going forward, we will continue to aggregate data in our Parkinson’s program and bolster our intellectual property portfolio for MANF in other indications. With a market opportunity that we estimate to exceed $5 billion annually, we believe this is the best way to maximize the value of MANF at this critical phase in its product development cycle, as well as strategically position Amarantus to capitalize on various opportunities that are in best interest of the Company and our shareholders.
We’re very excited about the direction of Amarantus and look forward to updating shareholders on additional progress in the coming weeks.