2H-2014: Milestones ahead to Position Amarantus for the Up-list
“Success is the child of drudgery and perseverance. It cannot be coaxed or bribed; pay the price and it is yours.”
Orison Swett Marden
The first half of this year has been a period of significant transformation and growth for Amarantus from a number of important perspectives. We have improved and fortified our pipeline with the addition of Eltoprazine for Parkinson’s LID that we expect will initiate late-stage therapeutic development this year. Secondly, we have added tremendous talent to our management with the collective career experiences to execute on our vision of building a world-class, global, biotechnology holding company with the wherewithal to deliver strategic asset development. We have also dramatically improved our cash position, access to capital and balance sheet in preparation for the anticipated up-listing of our common stock to a national exchange in the second half of 2014. With critical accomplishments now behind us, we are focused on executing key milestones going forward, and delivering value from our current stable of assets. We will also remain opportunistic to strategically adding to our pipeline via our wealth of relationships in the space.
As we prepare to communicate our long-term plans, following strategic events scheduled for the summer of 2014, we believe that we will continue to build shareholder value over the next 6 months as a result of the foundation laid in years past. These efforts span across our pipeline:
The Company has had 3 posters accepted for presentation (analytical performance, LP001 retrospective 7 year patient record clinical performance data, and LP002 2014 clinical performance) at the Alzheimer’s Association International Conference (AAIC) this July in Copenhagen under the direction of Dr. Louis Kirby and Paul Jorgensen. Our primary focus will be the data of the LP001 retrospective patient record study currently underway with our collaborator’s facility at Banner Sun Health Research Institute in Phoenix, AZ. We believe this data will be the most compelling for Key Opinion Leaders (KOLs) and pharmaceutical companies, our target market for the initial launch of LymPro, as this will provide longitudinal data regarding LymPro’s performance and diagnostic integrity.
The Company is contemplating withholding the release of the LP002 clinical performance data until our #C4CT Concussion Awareness Summit, which will focus on TBI-induced Alzheimer’s disease, at the United Nations on July 31st. This would allow the Company to maintain a laser focus on potential customers at AAIC using the most compelling LP001 retrospective data and allowing the information to be thoroughly digested by the scientific community and analysts. In doing so, the LP002 data would be shared with family offices and a world-expert panel of TBI and Alzheimer’s researchers who would then be in a position to sign on as sites for the validation study required for CLIA registration. We will update the market on this option in the weeks ahead.
With regards to a partnership agreement to allow for the CLIA launch of LymPro in 2014, we are currently working through the intricacies of what such an agreement would entail. We have identified the laboratory that we believe has the technical know-how and marketing capabilities required for the launch of the LymPro Test both within the clinical trials setting to support pharmaceutical development, as well as a commercial launch under CLIA. We expect to be in a position to deliver definitive information to the marketplace over the summer. We believe the data to be released at AAIC and potentially the #C4CT Summit will increase the value of LymPro and give us additional leverage in negotiations.
Following the release of this data, we intend to outline a forecast for LymPro revenues and market uptake in our second quarter earnings conference call that will provide the basis for financial projections. We continue to make progress implementing our reimbursement strategy, which will give the Company additional leverage in potential partnership negotiations.
We believe LymPro could become the standard blood test for Alzheimer’s disease in the marketplace and we intend to move rapidly and diligently to unlock LymPro’s inherent value.
Our Therapeutic Chief Medical Officer, Dr. Charlotte Keywood, and her team have done a tremendous job in putting together the planning required for the Eltoprazine Parkinson’s disease LID clinical trial. At the current time, we are completing the analysis of comparing the pros and cons of a robust Phase 2b clinical trial vs. a Phase 2/3, and identifying what would make the Eltoprazine more attractive from a partnering perspective post-trial. We will be attending the Biotechnology Industry Organization’s annual international meeting in San Diego next week and have numerous meetings setup with large pharmaceutical companies to get a sense of how these companies will view the 2 trial design options. The Company has retained the regulatory expertise required to move our clinical development process forwards and is currently implementing IT infrastructure improvements to support a trial of this magnitude. We believe strongly that Eltoprazine has the opportunity to become the standard treatment for Parkinson’s LID.
The team at NeuroAssets, under the direction of Dr. David Lowe, has been doing a tremendous job of implementing our MANF strategy. We have experiments underway at multiple CROs, as well as a collaboration agreement being moved forward with the University of Miami’s Bascom Eye Institute, evaluating the safety and efficacy of MANF in multiple models of Retinitis Pigmentosa. While these experiments are underway, with data expected in the next several weeks, we are concurrently putting together the necessary orphan regulatory expertise to apply for Orphan Drug Designation (ODD) with the FDA. We expect to be in a position to file for ODD with the FDA for MANF in Retinitis Pigmentosa shortly after receiving the final data sets over the summer.
In addition, we have been working hard to establish a research collaboration in Wolfram syndrome for MANF’s development in that indication. We have been successful in establishing strong relationships with key researchers in Wolfram’s, and we believe these relationships will be critical in our efforts to enter development in that indication. We expect to have information to disseminate to the marketplace in the very near future.
Simultaneously, we are working with Renishaw to complete experiments on evaluating the feasibility of using their delivery system for MANF in Parkinson’s disease in large animals. We note that a competitor, Medgenesis Therapeutix, is likely to be releasing data on GDNF using Renishaw’s device in the very near future. We believe the safety components of that data will be highly instructive when it comes to gleaning insights on the human feasibility of the delivery of MANF to the brain. The data from our initial experiments from Renishaw, combined with Renishaw’s human data for GDNF, should dramatically increase visibility on the feasibility of MANF as a solution for Parkinson’s patients.
The Company is also continuing to move forward with other initiatives on the MANF front with Dr. Larry Schwartz at the University of Massachusetts, including the further evaluation of MANF as a treatment for the orphan indication antibiotic-induced ototoxicity, as well as other undisclosed possibilities. We believe it is absolutely critical to collaborate with leading academic groups who hold specialties in the various areas pertaining to MANF’s fundamental biology, and we expect multiple announcements on this front in the near future. The literature being developed with respect to MANF is quite significant, including in diabetes and cardiovascular disease, and our recent trip to China has opened our eyes to significant possibilities for collaboration with highly credible Western entities who have established operations in the Far East. We believe we can leverage our academic network and the emerging scientific critical mass in China to further our interests throughout the world across a number of value-building endeavors.
In closing, I would like to thank our shareholders for your continued support as we grow our business and achieve the milestones we have set before us. We have a clear plan and strategy, and are working to establish appropriate channels for scientific, development and financial partnerships that will provide near and long-term value creation possibilities across multiple fronts. Our strategy remains to up-list our common stock in 2014, and we believe we have the scientific credibility, diversity of assets and value creation milestones to achieve that objective while simultaneously allowing for further value creation once up-listed. We are quite pleased with our progress and look forward to additional updates in the weeks and months ahead.
Gerald E. Commissiong
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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