2014: Initiation of Eltoprazine Phase 2b and LymPro Commercialization
This week has been a tremendous success for the Company as we have dramatically increased fundamental shareholder value for Amarantus and gained tremendous exposure during the week of the 32nd Annual JP Morgan Healthcare Conference in San Francisco with our recent in-license of Eltoprazine for Parkinson’s disease Levadopa-Induced Dyskinesia (“PD LID”). We began the week knowing that overnight, we would shift from an attractive pre-clinical platform to a robust Phase 2b PD pipeline company with the in-license of Eltoprazine. Moreover, the fact that Eltoprazine fits strategically with our MANF Parkinson’s program and has received substantial non-dilutive funding to generate the highly statistically significant data produced in the most recent PD LID trial suggests that we are now well positioned from an asset standpoint and we will be seeking clinical data and upcoming milestones to support valuation. We are working to move rapidly to initiate the Phase 2b trial as we believe this will be a key factor in driving valuation as we look to move to a national exchange and gain exposure to a more robust capital markets environment. The reprioritization of the MANF program towards orphan diseases continues under the direction of NeuroAssets’ seasoned team of biotech executives with data expected in the weeks and months ahead. There is no question that Amarantus now has one of the most exciting PD pipelines in the industry, with an up and coming orphan program that could reshape a number of diseases for which there are currently no marketed products. LID is currently the most critical unmet medical need in Parkinson’s disease management today and represents a tremendous market opportunity. The data we have gives us great confidence as we plan the late-stage clinical studies that will be initiated later this year.
While much of the attention this week has focused on Eltoprazine, this has also created an opportunity for the public to review our pipeline and become familiar with our LymPro diagnostic blood test for Alzheimer’s disease (AD). With commercialization expected later this year, the investment community has become interested in the manner in which we intend to make this dramatic shift to a revenue generating company. With the help of our advisors, we are ensuring that we build value for the program as rapidly as possible by evaluating all the necessary steps for commercialization to de-risk the asset both for Amarantus, as well as prospective partners. Negotiations with 3rd parties center around the value Amarantus would be able to bring to a prospective business arrangement, and are fundamentally focused on certain key areas:
- Intended Use Statement
- Sensitivity and specificity of the assay
- Reliability of the assay
- Market Size
- Regulatory Pathway
- Reimbursement Pathway
Currently, LymPro is being developed for a critical unmet medical need in a $200B/year market expected to grow to $1.2T (yes trillion) by 2050 with a reasonably low regulatory burden for initial launch and has demonstrated high sensitivity and specificity in 2 separate peer-reviewed publications. The Company is focused on improving its value while mitigating the potential risks associated with the development of LymPro by ensuring long-term reliability, defining the ultimate FDA and multinational strategy with our key Alzheimer’s advisors and ensuring that upon commercial use of the assay, the ultimate selling entity will have an established method of reimbursement. We believe that we are making significant progress on all of these fronts and intend to formally update the marketplace as these key events are solidified. Each one of these de-risking steps, especially reimbursement, dramatically improves the net present value of LymPro which in turn would increase its attractiveness to physicians, investors and potential partners. We believe that we are in a great position to bolster the value of the LymPro asset in a very short period of time by employing this strategy, thereby increasing potential competition for the assay while giving the Company as many options as possible for ultimate value creation.
Neurodegenerative diseases are poised to become one of the great challenges of our time with the aging population, and Amarantus has transformed itself in just over a year into a Company with therapeutic and diagnostic assets near to commercialization in critically important indications for the future of healthcare in the US and abroad. We are excited with this progress and believe it is the beginning of our value creation cycle and will provide a solid foundation for the Company as we continue the development of MANF in the area of orphan indications, and ultimately other applications related to protein misfolding and apoptosis.
Thank you for taking the time to read this blog and I am looking forward to a successful 2014 for AMBS.
President & CEO
c/o Janssen Labs @ QB3
953 Indiana Street
San Francisco, CA 94107
Phone: (408) 737-2734
Fax: (408) 852-4427
Aimee Boutcher, Director of Investor Relations
Phone: (408) 737-2734 x 101
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