Amarantus BioScience Holdings, Inc. (otcqb:AMBS)

DD Compilation

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PR: http://www.amarantus.com/investor-relations/press-releases-news-articles.html


On November 7, 2012, Amarantus BioSciences, Inc. issued a Convertible Promissory Note to an individual private high-net worth investor in the principal amount of $50,000.00. The Note bears interest at the rate of six percent (6%) per annum until paid in full converts and automatically into shares of Amarantus common stock at the price of $0.05 per share upon maturity. The use of proceeds from this note are restricted to:

1. Analyzing, processing and submitting data from the Company’s ongoing animal experiments comparing MANF and GDNF to the Michael J. Fox Foundation, to be completed within 45 days;

2. Completing the recruiting of the scientific team required to re-validate Phase 1 clinical data of the Company’s NuroPro Parkinson’s Disease Blood Test, to be completed within 30 days;

3. Completing the recruiting of certain key seasoned biopharmaceutical executives to the Company’s management team and Board of Directors, to be completed within 15 days;

4. Finance the Company to a more substantial financing event.


    1. Completed: Data presented at OneMedForum to big pharma and high net investors

    2. Completed: Ready for Phase II testing.  Awaiting MJF grant expected February 20th, and possible RBCC JV.  First revenue expected to be generated in 2013.

  1. NuroPro has completed a Phase 1 human clinical trial, and JV will initiate a Phase 2 clinical study upon successfully repeating the Phase 1. Upon completing Phase 2, RBCC and Amarantus expect NuroPro to begin generating revenue through sales under a Clinical Laboratory Improvement Amendment (CLIA) certification

    1. Completed:

    1. Dr. Rubinfield, cofounder of AMGEN added to corporate advisory board.

  1. “I believe in MANF,” said Dr. Rubinfeld, “I have reviewed a great number of technologies in my 45 year career in the biopharmaceutical field, and I believe that MANF could be one of the biggest successes that I have ever seen. The fundamental scientific premise of reducing protein misfolding is basic, yet very profound. The data, while early, demonstrates very clearly at the cellular level and in animals that MANF reduces apoptosis, improves cellular function, and restores behavioural deficits in a number of disease models, including Parkinson’s, Stroke, Myocardial Infarction and Traumatic Brain Injury. These are all indications with very large markets and clear unmet medical need. I believe that if we are able to further de-risk MANF with positive toxicology studies and early clinical data, the Company’s new orphan drug strategy could get MANF to market rather expeditiously.  MANF has the commercial potential to become a blockbuster drug.”

  2. This guy helped launch AMGEN from penny land to $80+ PPS.  He’s 79 years old and has made millions and millions of dollars already.  He has no incentive to go on record like this unless he truly believes in MANF, which he does.  http://www.forbes.com/profile/joseph-rubinfeld/

    1. Dr. Zimmerman added to corporate advisory board.  Has held executive positions in multiple big pharma companies, including Bayer Corp. and Bristol Myers

    2. Clinton Allen added to corporate advisory board.

  1. Point of interest- Zimmerman, Allen, and Rubinfield have all held positions at Bristol Myers… potential buyout candidate along with AMGEN obviously.  Bristol Myers is hosting GDNF Phase II human clinical trials currently (explained later).

    1. Completed:

    1. “Amarantus Secures $1.1 million in new financing.” Also gunning for national exchange up-list (explained later)

  1. Amarantus BioScience Secures an Additional $1.4 Million in Financing Commitments

    • November 18th AMBS presents at CNS Summit to dozens of big pharmas, including AMGEN, and receives positive feedback.

    • November 20th AMBS announces victory in patent dispute with Hermo Pharma over MANF

    • Point of interest- Henri is CEO of Hermo Pharma who challenged MANF patents and lost.  Here he goes on record talking about his biggest competition, AMBS and MANF.

    • Henri: One important contributor of GDNF’s failure in the clinic was likely its very limited distribution in the brain. Natural forms of GDNF and many other related proteins such as Neurturin (Ceregene) bind strongly to extracellular matrix proteoglycans which limit its distribution after infusion. There are some strategies in development to alter these sites in GDNF/Neurturin to improve their distribution in the brain. Very importantly, the natural forms of CDNF and MANF do not bind to these heparin-type proteoglycans and distribute much more widely than GDNF/Neurturin when injected into the brain…..

    • In the past ten years, intracerebral delivery technology for protein drugs has developed quite a bit – of course many lessons were learned from the GDNF trials. Also, during this time deep-brain stimulator has become a widely accepted aid for PD patients. The surgical operation for implantation of DBS electrodes is highly similar to implantation of infusion catheters. So, in a way, we are now well-positioned to start testing the efficacy of therapeutic proteins – instead of developing delivery technologies. Prof. Steven Gill has recently initiated a new Phase 2 study with GDNF in Bristol, using improved delivery methods.

  • GDNF has paved the way to success for MANF already.  After  years of trial and error, Hermo Pharma and Bristol Myers have successfully delivered GDNF to human patients’ brains.  Their only obstacle left is that GDNF binds to heparin-type proteoglycans, which MANF does not.  MANF has all it needs to fly through clinical stages of development.

    • After AMGEN originally halted GDNF clinical trials, multiple patients who received GDNF sue AMGEN in an attempt to continue receiving GDNF which they believed was helping their Parkinsons.  The courts sided with AMGEN.

    • November 26th: AMBS explores orphan drug designation for MANF

    • November 27th: AMBS announces positive data for MANF in delivery diffusion in animal models

  • http://www.amarantus.com/wp-content/uploads/2012/11/121127-PR-AMBS-Delivery-Distribution-FINAL-remy.pdf

  • “The data generated in this study show that when compared to GDNF, a neurotrophic factor currently in a Phase 2 clinical trial for Parkinson’s disease, MANF had a significantly higher volume of distribution when delivered to the striatum…. Seven days following delivery under best available conditions, MANF’s diffusion volume was ~30% greater than GDNF’s.”

  • “Diffusion from the site of delivery in the brain has been a key problem plaguing the development of other neurotrophic factors for Parkinson’s disease for some time. We now have further evidence that MANF appears to have added biological advantages over other neurotrophic factors in development, and the Company intends to leverage these results as we continue to advance our Parkinson’s program.”

    • December 3rd: AMBS completes name change and CUSIP change

  • http://www.amarantus.com/wp-content/uploads/2012/12/121203-PR-AMBS-CUSIP-change-FINAL.pdf

  • The CUSIP change forced the cover of NSS positons. This worked by preventing the trading of shares with the old CUSIP # and created an entirely new set of shares through the DTC. By doing this, the DTC is forced to account for ALL of the old shares exchanged for the new shares. Without the name change, the old shares would simply be renamed. With the name change, they are physically exchanged which isolated phantom shares and forced covering. This was part of a huge short squeeze which catalyzed the AMBS run from .019s to .19s.  The same is possible in the upcoming Berlin Stock Exchange delisting under progress as of February 2013.


    • December 4th: AMBS appoints Super Bowl champion Toi Cook to board of advisors to advance TBI program.

    • December 6th: AMBS to present at OneMed Forum (with webcast for shareholders) to attract potential big pharma and high net investors

    • December 11th: AMBS launches corporate communication channels.

    • “We just completed our first institutional capital raise and have attracted Big Pharma talent to our Advisory Board. We have data coming shortly on our MANF Parkinson’s program and expect additional corporate milestones will be reached in the coming weeks. As we achieve these milestones, we believe we will be in a good position to up-list to a national exchange.”

  • If you look back to the last time AMBS promised shareholders something moving forward (November 7th PR with 15, 30, 45 day milestones), they are pretty reliable at getting what they say they are going to do done.  The CEO and employees are all shareholders themselves, so they are going to do everything in the best interest of this stock’s PPS.


PARKINSON’S FUNDED GRANT

Comparison and Actions of MANF and GDNF in Rodent Models of Parkinson’s Disease

GRANT ABSTRACT

Objective/Rationale:

Parkinson’s disease (PD) is caused by the degeneration of certain dopaminergic neurons in the brain. Neurotrophic factors like GDNF protect dopaminergic neurons from degenerating in animal models of PD, but have so far not worked in clinical trials. MANF is a new neurotrophic factor that is strongly indicated for PD. This project will compare MANF and GDNF in new animal models of PD to determine if MANF is likely to be more effective than GDNF in clinical trials for PD.

Project Description:

The cell bodies of the dopaminergic neurons that degenerate in the human brain and cause PD are located in the substantia nigra, and their terminals project to the putamen (called the striatum in rats). We will mimic the death of dopaminergic neurons in the human brain using the neurotoxin 6-hydroxydopamine (6-OHDA) to selectively kill dopaminergic neurons. The animals will then be treated with GDNF or MANF to try to protect the dopaminergic neurons from degenerating. We will deliver MANF or GDNF to the striatum or substantia nigra in separate experiments, and directly compare the improvement of neurological deficits with the survival of dopaminergic neurons in the substantia nigra. This is one of the first projects to directly compare drug delivery to the substantia nigra versus the putamen.

Relevance to Diagnosis/Treatment of Parkinson’s Disease:

The results of this project could open the way for patients with PD to be successfully treated with MANF and/or GDNF. So far, neurotrophic factors have been delivered to the putamen in clinical trials. New surgical techniques now make delivery to the small substantia nigra, located deep in the brain possible. Delivery to the substantia nigra could increase the chances of success of GDNF and MANF in future clinical trials.

Anticipated Outcome:

We expect to use the results of this project to prioritize available drugs, and improve the design of future clinical trials of neurotrophic factors for PD. First, is MANF less effective, as effective or more effective compared with GDNF as a treatment for PD?  Second, what should be the target for the delivery of the drug, the putamen, the substantia nigra, or both?  The investigators believe that neurotrophic factors to treat PD will be more effective when delivered to the substantia nigra.

INTERIM PROGRESS REPORT

MANF is one of two new molecules (the other is CDNF) currently in pre-clinical development for the treatment of Parkinson’s disease. In a recently completed pre-clinical model of Parkinson’s disease funded by MJFF, MANF corrected the neurological deficits when it was given immediately after the animals became sick. MANF also corrected the neurological deficits when it was given three weeks after the models became sick. This means that MANF is able to prevent the death of healthy dopaminergic neurons, but also MANF can save dopaminergic neurons that are already dying. How do these results apply to human patients? The results suggest that in patients newly diagnosed with Parkinson’s disease MANF might be able to save those dopaminergic neurons that are sick and dying, but not yet dead. These patients will likely get better sooner, and their recovery will also last for a longer time. It is much too soon to predict whether MANF will be able to cure Parkinson’s disease. MANF is certainly one of the most promising molecules currently in development to treat this debilitating disease.

https://www.michaeljfox.org/foundation/grant-detail.php?grant_id=644

Complete History of GDNF can be found here:

http://www.pdpipeline.org/2011/GDNF/gdnf_table.htm

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CEO BLOG (1/14/2013) Onwards and Upwards: Building Value From a Solid Foundation


SOURCE: http://www.thechairmansblog.com/gerald-commissiong/2013-01/onwards-and-upwards-building-value-from-a-solid-foundation.html


The last few weeks have been very exciting for Amarantus. Since our initial Chairman’s Blog post on December 11th, 2012 we have achieved several important corporate milestones to set the stage for growth in 2013, including:


Publicly releasing groundbreaking efficacy data for our protein drug candidate MANF in a neurorestoration animal model of Parkinson’s disease, our lead therapeutic indication;

Acquiring 25 pieces of intellectual property from Power3 Medical Products, Inc. (“Power3”) related to the diagnosis of a number of neurodegenerative diseases and cancers. The transaction also included the buyout of our Parkinson’s disease license with Power3; and

Licensing a Phase 2-ready Alzheimer’s disease diagnostic blood test called LymPro to detect mild to moderate Alzheimer’s disease; a diagnostic category highly sought by Big Pharma


The fundamentals of the Company have continued to progress and this was validated last week when the Company attended two key conferences in San Francisco, where we met with research analysts, fund managers and pharmaceutical executives. This increase in awareness also comes with a significant increase in scrutiny as it relates to the manner in which our data sets are presented and our financing plans. Therefore, I will address some of these key areas here:


The data the Company released last week related to our MANF program in Parkinson’s disease is groundbreaking and first of its kind in the Parkinson’s space. Our Chief Scientific Officer, Dr. John Commissiong, presented the data at the OneMedForum 2013 Healthcare Conference, and showed a significant positive impact in every data category, thus supporting advancing MANF in both Investigational New Drug (“IND”)- enabling studies and human clinical studies. From an academic standpoint, the data produced represents a new ‘positive control’ for this model, heretofore changing the way these experiments are performed in academic labs throughout the world, with MANF likely becoming the new standard. As such, it is important for the experiments to be repeated in academia to get the most efficacious dosing regimen in the model so that new therapies can be compared against the budding new standard, MANF.

While we are constantly evaluating options as it relates to our financial structure, including grants, partnerships, joint ventures, collaborations, and securities offerings, the Company has not made any specific decisions as to its next steps in this regard, despite misleading articles written on certain websites. The Company believes these misleading statements may be intended to dampen market enthusiasm, while enhancing trading strategies for certain trading groups. We are evaluating legal options as it relates to these misleading statements and the Company will continue to work to defend shareholder value. Concurrently with this, we will be taking stronger action against the unauthorized listing of our common stock on the Berlin Stock Exchange, as the Company believes the misleading articles may be related to this listing.


As MANF continues forward in its development, the Company expects to build the most accretive value in the near-term from its diagnostic assets. As previously discussed, the Company is now in an excellent negotiating position with potential partners and investors interested in advancing our diagnostic candidates forward on favorable terms so we can devote the majority of our internal resources to our MANF programs in Parkinson’s disease, Traumatic Brain Injury, Cardiac Ischemia and the evaluation of certain orphan indications. We will update the marketplace regarding our diagnostic assets and plans for their continued development in the near future.


In closing, the future has never looked brighter for Amarantus. We have unambiguous data supporting MANF’s further development in our lead Parkinson’s disease indication, we now have rights to seven diagnostic blood tests in significant markets, and our MANF asset continues to make progress in secondary indications. We are looking forward to an exciting 2013 for the Company and its shareholders.


I thank you for taking the time to read this letter and looking forward to communicating with you in the future.


Sincerely,


Gerald E. Commissiong


President & Chief Executive Officer


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1/2/13 Update:


Fellow AMBS longs,


Stock Board Assets founder, Alastair Williamson, was lucky enough to snag a quick interview with an ex-NFL player on Traumatic Brain Injury (TBI).  In the interview, Alastair asks Keion Carpenter about his thoughts on TBI and discusses a possible re-vamping of the NFL’s TBI Awareness Program following the devastating and sorrowing events that unfolded this year.  There was a murder suicide involving a Kansas City Chiefs linebacker and his girlfriend at Arrowhead Stadium.  Additionally, huge litigations are booming down on the NFL from players and ex-players, including Toi Cook who is now with AMBS.  The media looks poised to refocus its awareness efforts with the NFL from Breast Cancer to TBI in my opinion.  The perfect storm continues to build, imagine AMBS blazing the trail in a renewed nation-wide effort to fight Traumatic Brain Injury.  We could potentially be in the Orphan Market for TBI right around when the NFL starts back up again next season.  Enough of my rambling, here’s the video.  Enjoy!


http://www.youtube.com/watch?v=bGxZHz_KNCI&feature=youtu.be

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As you can see, Rubinfield is essentially the Steve Jobs of biotechs.  To have him presenting for our penny stock speaks volume.  These conferences are where biotechs customarily release their data results, and it is truly an exciting time given the nature of our preliminary results (30-40% better than GDNF).  GDNF was valued at $250 million in this stage of its development, which is around 1/10th of our market value on almost any given day!  But this is all old news, I now would like to put an end to the dilution conspiracy theory which has been overtaking certain boards.


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  • AMBS $2 PPS Uplisting Goal Explained



“The most critical milestones for us to achieve in the next 12 months are:

  • Raising sufficient capital to efficiently fund our therapeutic and diagnostic programs;

  • Advancing our various product development programs to key value inflexion milestones;

  • Finalizing the business development transactions executed over the past 12 months;

  • Recruiting seasoned product development expertise in the areas of biopharmaceutical and diagnostic product development;

  • Listing our common stock on a national stock exchange.”


This ^ was a PR excerpt which was posted last May (5/7/12).  The CEO said we were in a good position to pull this off in his recent blog entry!


    • “In closing, this is a very exciting time for Amarantus. We just completed our first institutional capital raise and have attracted Big Pharma talent to our Advisory Board. We have data coming shortly on our MANF Parkinson’s program and expect additional corporate milestones will be reached in the coming weeks. As we achieve these milestones, we believe we will be in a good position to up-list to a national exchange.”

Now I know a lot of you non-believers are scratching your heads wondering how in the hell AMBS could even be close to $2 by May.  While I agree that this would be a truly impressive accomplishment for AMBS, it is very possible.  Why? Because of the often overlooked diagnostics tests AMBS currently has in clinical human trials.  NuroPro is the diagnostics test for Parkinsons and LymPro is a similar diagnostics test for Alzheimers.  These both are blood tests that rely on biomarkers.  Check this out, and enlighten yourselves with why us longs have been accumulating the majority of the float in AMBS throughout the extreme volatility:

  • NuroPro has completed a Phase 1 human clinical trial, and JV will initiate a Phase

clinical study upon successfully repeating the Phase 1. Upon completing Phase 2, RBCC and Amarantus expect NuroPro to begin generating revenue through sales under a Clinical Laboratory Improvement Amendment (CLIA) certification.

“We’ve identified valuable upside in NuroPro, and we expect this project to begin paying for itself within a short period of time,” said Amarantus President & CEO Gerald Commissiong. “The ability to advance NuroPro that will simultaneously generate revenue while bolstering our MANF program by allowing our clinical researchers to more efficiently select and monitor Parkinson’s patients in our therapeutic program represents a tremendous opportunity. The timing of initiating the JV will allow us to begin moving NuroPro forward in 2013.”

The market for Parkinson’s could grow to a value of $3.75 billion by 2015, according to a report last year by Visiongain analysts.


NeuroPro License Details

http://www.sec.gov/Archives/edgar/data/1424812/000125529412000050/ex10_1.htm


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This section is about the next economic boom, which happens to be
“NeuroTech Boom”. StockBoardAssets has identified the NeuroTech Boom to a specific geographical location….San Francisco. Over 100 public/private companies thrive in the San Francisco and surrounding areas which concentrate their efforts in neuroscience. The most astonishing part is Amarantus Bioscience happens to be in the epicenter of the boom.

About Neurotechnology Industry Organization

The Neurotechnology Industry Organization (NIO) is a non-profit trade association representing companies involved in neuroscience (pharmaceuticals, biologics, cell-based therapeutics, medical devices and diagnostics), brain research institutes and advocacy groups across the United States and throughout the world. NIO was founded in 2006 and has attracted over 90 members in support of our mission to “give the brain a voice.” http://www.neurotechindustry.org


Amarantus is 20 minutes from San Francisco, CA.

Via MUKA1 – Banyan/AMBS timeline to treat TBI


Jan 2012 Amarantus is introduced to Banyan by the US Dept of Defense to pursue interests in identifying and treating brain trauma.

http://www.drugdiscoverynews.com/index.php?newsarticle=5717


June 2012 –AMBS and Banyan report that “”data give us confidence to move to the next phase of testing to further validate this approach, as well as look at innovative product development strategies to accelerate bringing a MANF-based treatment to patients for TBI.”

http://content.stockpr.com/_news/amarantus/2012-06-07_Amarantus_BioSciences_and_Banyan_Biomarkers_Announ_13.pdf


March 2013 Banyan has something to talk about???

http://www.tbiconference.com/home/speakers


…sounds like it to me. AMBS+Banyan=blood test and treatment for TBI!!


“Amarantus BioSciences Inc. (OTCBB:AMBS), Sunnyvale, Calif. Banyan Biomarkers Inc., Alachua, Fla. Business: Neurology Amarantus partnered with Banyan to develop Amarantus’ mesencephalic astrocyte-derived neurotrophic”


And this grant funding and additional Dominion funding will make it possible…..big $$ is just beginning to come in!

“Received grant funding for a Traumatic Brain Injury collaboration with Banyan Biomarkers from Brewer Sports International;”

http://ih.advfn.com/p.php?pid=nmona&article=50239660

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2/11/13 Webcast Cliff Notes

http://ir.stockpr.com/amarantus/ir-calendar


·      LymPro and NuroPro expected to start generating revenue upon completion of Phase II clinical trials.

o   Finalizing protocols for initiation of Phase 2 Validation to support CLIA launch.

·      LymPro would be a cheap alternative to current Alzheimers diagnostic platforms.  $350-$450 revenue per test once Phase 2 is completed (already in progress).

o   97% degree of certainty thus far in identifying Alzheimers

·      NuroPro is similar to Alzheimers in its use of biomarkers to potentially diagnose Parkinsons.

o   Being revalidated in Phase 1 in preparation for Phase 2 launch.

o   Degree of certainty so far is in excess of 90%

·      $800 million + opportunity for diagnostic platforms alone.

·      Received grant from the state of Massachusets and Schwartz to evaluate MANF’s ability in Orphan Designation.  Gerald thinks it is highly likely for them to identify an Orphan Disease by the end of 2013 and reduce the time it will take MANF to reach market.

·      MANF pricing for Parkinson’s patients- $20,000 to $50,000.

o   Estimates = conservative

·      All data supports MANF as a potential disease modifying treatment, none of which currently exist in the Parkinson’s market.

o   2 companies, including Amgen, have potential to deliver MANF with the implanted catheter system, delivery technology that has improved significantly over the past decade.  “As of a result of this, the Company is currently evaluating business relationships with these potential partners and will be updating the market in the near future.”

·      2 more data sets coming out by end of March on MANF data

o   “Strong data thus far, and we believe that data will get stronger in the upcoming weeks.”

o   MANF is representative of breakthrough biology.

·      MANF total market opportunity exceeds $5 billion.

o   Total technology market opportunity for AMBS = $5.8 billion by conservative estimates

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