Amarantus Shareholder Update
Fundamental Progress on the Pipeline and Strategy Continues
Posted on Thursday, March 26th, 2015 at 8:01 am
http://www.thechairmansblog.com/amarantus-bio...continues/
The goal of my blog posting today is to provide an overview of the status of our Diagnostics and Therapeutics business units and outline the important milestones we expect to achieve over the course of the coming months.
Since our inception, we have structured Amarantus as a company focused on strategically assembling undervalued de-risked assets, which we then further de-risk by advancing through the realization of catalytic milestones. Three years ago today, the Company had a single asset, MANF, in development for Parkinson’s disease (PD). Since then, we have established two business arms through strategic acquisitions, our Diagnostic division and our Therapeutics division; each of which contain several emerging high value assets.
The LymPro® Test for Alzheimer’s disease (AD), MSPrecise® for the diagnosis of multiple sclerosis (MS) and the NuroPro® diagnostic for PD make up our Diagnostics division. In addition, we have entered into an option agreement with Georgetown University for a license for two more diagnostic assays for AD, because we believe the combination of these two assays with LymPro will cement our position as a leader in the emerging field of Alzheimer’s blood diagnostics. Taken together with our diagnostics for MS and PD, we have positioned our Diagnostics division as one of the premier neuro-diagnostic companies in the world.
Some recent diagnostics development highlights include:
LymPro
•Presenting positive LymPro data at the 12th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders;
•Establishing the Company’s first Investigational Use Only (IUO) Alzheimer’s biomarker services collaboration for LymPro Test with Anavex Life Sciences Corp. to evaluate blood samples from AD patients;
•Entering into a Letter of Intent with Anavex to plan additional scope of further biomarker services for its potential Phase 3 AD clinical trial; and
•Announcing the availability of LymPro Test biomarker services for use by the pharmaceutical industry for IUO.
MSPrecise
•Acquiring DioGenix, with a clinically validated, first-in-class next-generation sequencing assay, MSPrecise, which identifies multiple sclerosis at first clinical presentation.
Georgetown Assays
•Entering into a one-year, exclusive option agreement with Georgetown University to license patent rights for blood based biomarkers for AD and memory loss.
We’ve also made progress in our Diagnostics division towards the execution of one of our strategic goals, including:
•Retaining an executive search firm to identify a CEO for our Diagnostics division;
•Retaining Ravi Kiron, Ph.D., a co-founder in C2N and the former Chief Business Officer at Kinemed, Inc., to serve as Senior Vice President of Business Development where he is being tasked with sourcing additional biomarker services agreements for our Alzheimer’s assays;
•Promoting Colin Bier, Ph.D., to Chief Development Officer to oversee the commercialization of our assays under CLIA;
•Retaining a consulting firm specialized in the sale of tax credits, to market the $7.5 million of New Jersey tax credits obtained in the Diogenix acquisition; and
•Establishing an AD Diagnostics Scientific Advisory Board with three internationally-renowned AD and neurological disorder specialists, Paula T. Trzepacz, M.D., Jeffrey L. Cummings, M.D., Sc.D., and Robert A. Stern, Ph.D.
Our business strategy, as previously stated in shareholder communications, is to explore strategic options for our diagnostics division, including a potential spin-off, and put it in the hands of an experienced diagnostics-focused organization in order to derive the full value of what we have created over the last several years of incubating the division.
While building the Diagnostics division we added a very promising asset within our Therapeutics division. Last year we added a product candidate, eltoprazine, which is ready for Phase 2b trials for Parkinson’s disease Levodopa induced dyskinesia (PD-LID), adult ADHD and Alzheimer’s aggression indications. Further, we expanded the opportunities for MANF, beyond PD, into potentially high-value orphan ophthalmological indications. And finally, we have purchased an exclusive option agreement to acquire Engineered Skin Substitute Walkersville (ESS-W), another orphan product that will allow us to further build out our therapeutics pipeline once the exclusive option is exercised.
Some recent highlights in our Therapeutics division include:
Eltoprazine:
•Publishing Phase 2a clinical study results in BRAIN for the treatment of PD-LID; and
•Opening an Investigational New Drug (IND) application with the neurology division of the U.S. Food and Drug Administration (FDA) to develop eltoprazine into Phase 2b clinical studies.
ESS-W
•Entering into an exclusive option agreement with Lonza to acquire ESS-W; and
•Dismissing with prejudice the litigation that had previously encumbered ESS-W.
MANF
•Receiving Orphan Drug Designation (ODD) for MANF from the FDA for treatment retinitis pigmentosa (RP);
•Submitting an application to the FDA for ODD of MANF for treatment of retinal artery occlusion (RAO); and
•Announcing positive preclinical data on the effects of MANF for the protection from vision loss in an animal model of RP.
Importantly, if you look at comparable therapeutic companies such as Avanir Pharmaceuticals with a Phase 2 program in AD aggression, it would appear there is an opportunity for Amarantus to build substantial value with its Eltoprazine asset. Avanir was acquired in December 2014 by Otsuka for $3.5 billion. Similarly, in September 2014, Acorda acquired Civitas’ primarily for CVT-301, an end of Phase 2b treatment for episodes of PD, for $525 million. Another example would be InVivo, a company with a pipeline of regenerative medicine product candidates, which has a market capitalization of approximately $300 million. These market comparables provide the basis for us to believe Amarantus has the potential for significant upside from our Therapeutics division.
In our Therapeutics division, some key milestones we expect to achieve over the next few months are:
•Initiate a Phase 2b clinical study of eltoprazine in PD-LID in the 2Q 2015;
•Complete the acquisition of ESS-W and initiate a Phase 2 study mid-year 2015; and
•Receive a response on our ODD applications for MANF in RAO from the FDA, and from the European Medicines Agency (EMA) for MANF for the treatment of RP and RAO.
Although not reflected given the recent deterioration in our current price, I believe we’ve made tremendous progress in a relatively short period of time with near, mid and long-term value creation opportunities. Notwithstanding market fluctuations, I want to be clear and reassure you that the fundamentals of the company have not changed, and the investment thesis behind Amarantus deriving value from its therapeutic and diagnostic pipelines remains intact.
From a corporate perspective in the last eight months we have:
•Completed multiple closings of a Series E preferred financing to raise $7.0 million;
•Appointed Elise Brownell, Ph.D., to the newly created position of Senior Vice President of Operations and Program Management; and
•Appointed renowned drug development expert and co-founder of Amgen, Joseph Rubinfeld, Ph.D. to the Board of Directors.
The Company, for some time, has been reviewing its options to ‘up-list’ to a national stock exchange. In recent weeks, some of you have referred to the blog I published in August 2014 entitled, “Preparing Amarantus for the Up-list in 2H-14: Capital Markets Strategy.” In this blog, I discussed the steps to undertake to qualify for a listing on a national stock exchange. Shareholders voted overwhelmingly in favor of the direction management laid out for the company’s future in the subsequent shareholder vote. The Company began moving forward with this mandate by submitting an application to list on the NASDAQ early in the fourth quarter of 2014, and we are currently working with NASDAQ to meet the initial listing standards. An important reason for pushing the timeline for the up-listing back from the second half of 2014 was the unique opportunity that presented itself to acquire ESS-W, which came with several risks that we successfully navigated, including the dismissal of the litigation previously encumbering the asset which has paved the way for the acquisition to take place. We will now return to immediately focusing on the NASDAQ listing to position the company for an appreciation in value.
I know the recent share price performance has been disheartening and quite frankly unnerving for our some shareholders. I want to reassure you that fundamentally the Company’s pipeline has never been stronger, and we have positioned Amarantus for what we believe is an exciting 2015 ahead of us. We clearly understand our priorities and management and the board are committed to identifying the best path forward to bring the necessary capital into the company to enable us to execute on our business plan and our strategy of up-listing to a national exchange.
On behalf of the management team and board, it is our hope that update gives you renewed confidence in the company and reminds you of the reason you invested in Amarantus. We believe 2015 will be filled with significant fundamental milestones and tangible opportunities to unlock shareholder value. I want to sincerely thank each and every one of your for your continued support. I will keep you informed of our progress on all fronts over the coming weeks.
Warm Regards,
Gerald E. Commissiong
President & CEO
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Fundamental Progress on the Pipeline and Strategy Continues
Posted on Thursday, March 26th, 2015 at 8:01 am
http://www.thechairmansblog.com/amarantus-bio...continues/
The goal of my blog posting today is to provide an overview of the status of our Diagnostics and Therapeutics business units and outline the important milestones we expect to achieve over the course of the coming months.
Since our inception, we have structured Amarantus as a company focused on strategically assembling undervalued de-risked assets, which we then further de-risk by advancing through the realization of catalytic milestones. Three years ago today, the Company had a single asset, MANF, in development for Parkinson’s disease (PD). Since then, we have established two business arms through strategic acquisitions, our Diagnostic division and our Therapeutics division; each of which contain several emerging high value assets.
The LymPro® Test for Alzheimer’s disease (AD), MSPrecise® for the diagnosis of multiple sclerosis (MS) and the NuroPro® diagnostic for PD make up our Diagnostics division. In addition, we have entered into an option agreement with Georgetown University for a license for two more diagnostic assays for AD, because we believe the combination of these two assays with LymPro will cement our position as a leader in the emerging field of Alzheimer’s blood diagnostics. Taken together with our diagnostics for MS and PD, we have positioned our Diagnostics division as one of the premier neuro-diagnostic companies in the world.
Some recent diagnostics development highlights include:
LymPro
•Presenting positive LymPro data at the 12th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders;
•Establishing the Company’s first Investigational Use Only (IUO) Alzheimer’s biomarker services collaboration for LymPro Test with Anavex Life Sciences Corp. to evaluate blood samples from AD patients;
•Entering into a Letter of Intent with Anavex to plan additional scope of further biomarker services for its potential Phase 3 AD clinical trial; and
•Announcing the availability of LymPro Test biomarker services for use by the pharmaceutical industry for IUO.
MSPrecise
•Acquiring DioGenix, with a clinically validated, first-in-class next-generation sequencing assay, MSPrecise, which identifies multiple sclerosis at first clinical presentation.
Georgetown Assays
•Entering into a one-year, exclusive option agreement with Georgetown University to license patent rights for blood based biomarkers for AD and memory loss.
We’ve also made progress in our Diagnostics division towards the execution of one of our strategic goals, including:
•Retaining an executive search firm to identify a CEO for our Diagnostics division;
•Retaining Ravi Kiron, Ph.D., a co-founder in C2N and the former Chief Business Officer at Kinemed, Inc., to serve as Senior Vice President of Business Development where he is being tasked with sourcing additional biomarker services agreements for our Alzheimer’s assays;
•Promoting Colin Bier, Ph.D., to Chief Development Officer to oversee the commercialization of our assays under CLIA;
•Retaining a consulting firm specialized in the sale of tax credits, to market the $7.5 million of New Jersey tax credits obtained in the Diogenix acquisition; and
•Establishing an AD Diagnostics Scientific Advisory Board with three internationally-renowned AD and neurological disorder specialists, Paula T. Trzepacz, M.D., Jeffrey L. Cummings, M.D., Sc.D., and Robert A. Stern, Ph.D.
Our business strategy, as previously stated in shareholder communications, is to explore strategic options for our diagnostics division, including a potential spin-off, and put it in the hands of an experienced diagnostics-focused organization in order to derive the full value of what we have created over the last several years of incubating the division.
While building the Diagnostics division we added a very promising asset within our Therapeutics division. Last year we added a product candidate, eltoprazine, which is ready for Phase 2b trials for Parkinson’s disease Levodopa induced dyskinesia (PD-LID), adult ADHD and Alzheimer’s aggression indications. Further, we expanded the opportunities for MANF, beyond PD, into potentially high-value orphan ophthalmological indications. And finally, we have purchased an exclusive option agreement to acquire Engineered Skin Substitute Walkersville (ESS-W), another orphan product that will allow us to further build out our therapeutics pipeline once the exclusive option is exercised.
Some recent highlights in our Therapeutics division include:
Eltoprazine:
•Publishing Phase 2a clinical study results in BRAIN for the treatment of PD-LID; and
•Opening an Investigational New Drug (IND) application with the neurology division of the U.S. Food and Drug Administration (FDA) to develop eltoprazine into Phase 2b clinical studies.
ESS-W
•Entering into an exclusive option agreement with Lonza to acquire ESS-W; and
•Dismissing with prejudice the litigation that had previously encumbered ESS-W.
MANF
•Receiving Orphan Drug Designation (ODD) for MANF from the FDA for treatment retinitis pigmentosa (RP);
•Submitting an application to the FDA for ODD of MANF for treatment of retinal artery occlusion (RAO); and
•Announcing positive preclinical data on the effects of MANF for the protection from vision loss in an animal model of RP.
Importantly, if you look at comparable therapeutic companies such as Avanir Pharmaceuticals with a Phase 2 program in AD aggression, it would appear there is an opportunity for Amarantus to build substantial value with its Eltoprazine asset. Avanir was acquired in December 2014 by Otsuka for $3.5 billion. Similarly, in September 2014, Acorda acquired Civitas’ primarily for CVT-301, an end of Phase 2b treatment for episodes of PD, for $525 million. Another example would be InVivo, a company with a pipeline of regenerative medicine product candidates, which has a market capitalization of approximately $300 million. These market comparables provide the basis for us to believe Amarantus has the potential for significant upside from our Therapeutics division.
In our Therapeutics division, some key milestones we expect to achieve over the next few months are:
•Initiate a Phase 2b clinical study of eltoprazine in PD-LID in the 2Q 2015;
•Complete the acquisition of ESS-W and initiate a Phase 2 study mid-year 2015; and
•Receive a response on our ODD applications for MANF in RAO from the FDA, and from the European Medicines Agency (EMA) for MANF for the treatment of RP and RAO.
Although not reflected given the recent deterioration in our current price, I believe we’ve made tremendous progress in a relatively short period of time with near, mid and long-term value creation opportunities. Notwithstanding market fluctuations, I want to be clear and reassure you that the fundamentals of the company have not changed, and the investment thesis behind Amarantus deriving value from its therapeutic and diagnostic pipelines remains intact.
From a corporate perspective in the last eight months we have:
•Completed multiple closings of a Series E preferred financing to raise $7.0 million;
•Appointed Elise Brownell, Ph.D., to the newly created position of Senior Vice President of Operations and Program Management; and
•Appointed renowned drug development expert and co-founder of Amgen, Joseph Rubinfeld, Ph.D. to the Board of Directors.
The Company, for some time, has been reviewing its options to ‘up-list’ to a national stock exchange. In recent weeks, some of you have referred to the blog I published in August 2014 entitled, “Preparing Amarantus for the Up-list in 2H-14: Capital Markets Strategy.” In this blog, I discussed the steps to undertake to qualify for a listing on a national stock exchange. Shareholders voted overwhelmingly in favor of the direction management laid out for the company’s future in the subsequent shareholder vote. The Company began moving forward with this mandate by submitting an application to list on the NASDAQ early in the fourth quarter of 2014, and we are currently working with NASDAQ to meet the initial listing standards. An important reason for pushing the timeline for the up-listing back from the second half of 2014 was the unique opportunity that presented itself to acquire ESS-W, which came with several risks that we successfully navigated, including the dismissal of the litigation previously encumbering the asset which has paved the way for the acquisition to take place. We will now return to immediately focusing on the NASDAQ listing to position the company for an appreciation in value.
I know the recent share price performance has been disheartening and quite frankly unnerving for our some shareholders. I want to reassure you that fundamentally the Company’s pipeline has never been stronger, and we have positioned Amarantus for what we believe is an exciting 2015 ahead of us. We clearly understand our priorities and management and the board are committed to identifying the best path forward to bring the necessary capital into the company to enable us to execute on our business plan and our strategy of up-listing to a national exchange.
On behalf of the management team and board, it is our hope that update gives you renewed confidence in the company and reminds you of the reason you invested in Amarantus. We believe 2015 will be filled with significant fundamental milestones and tangible opportunities to unlock shareholder value. I want to sincerely thank each and every one of your for your continued support. I will keep you informed of our progress on all fronts over the coming weeks.
Warm Regards,
Gerald E. Commissiong
President & CEO
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