Amarantus Bioscience Holdings, Inc. · OTC:AMBS
Amarantus Bioscience — Corporate Update (November 2014)
28 slides from Amarantus Bioscience's corporate update, Nov 18, 2014
Slide 1: Business Update and ESS Product Acquisition Option
1 Diagnostic and therapeutic products in the areas of neurology, psychiatry, ophthalmology and regenerative medicine BUSINESS UPDATE AND ESS PRODUCT ACQUISITION OPTION November 18, 2014 1 OTCQB: AMBS
Slide 2: Forward-Looking Statements
2 This presentation contains “ forward - looking statements ” within the meaning of the “ safe - harbor ” provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of the Co
Slide 3: Recent Operational Highlights
Recent Operational Highlights Corporate x Strengthened Board of Directors with the appointments of seasoned biopharmaceutical industry executives Iain Ross and Donald Huffman. x Received approval for all matters voted upon at its annual shareholder’s meeting. Eltoprazine x Submitted a request for wr
Slide 4: Recent Operational Highlights (Cont'd)
Recent Operational Highlights (Cont’d) LymPro x Reported positive data from 72 patients in the LP - 002 clinical performance study for diagnosing Alzheimer's disease showing the LymPro Test achieved highly statistically significant results in correctly distinguishing patients with moderate - to - se
Slide 5: Recent Operational Highlights (Cont'd) Financial Updates
Recent Operational Highlights (Cont’d) Financial Updates x Research and development costs for the three months ended September 30, 2014 increased $1,610,000 to $1,899,000 from $289,000 for the three months ended September 30, 2013 and reflects an extensive amount of pre - clinical and clinical work.
Slide 6: AMBS Core Competence in Uncovering Groundbreaking Opportunities
AMBS Core Competence in Uncovering Groundbreaking Opportunities Screening expertise in identifying assets with challenges and transforming into significant product opportunities for portfolio expansion 6 LymPro Test® Eltoprazine MANF ESS
Slide 7: Process for Identifying Candidates
Process for Identifying Candidates x Core scientific competence among key scientists in our sphere of influence (KOLs) x Compelling & sound /validated science that address key unmet clinical need x Extensive due diligence to ascertain ‘drugability’ of the opportunity x Little to no ‘effective’ compe
Slide 8: Portfolio Expansion into Regenerative Medicine
Portfolio Expansion into Regenerative Medicine 8 Amarantus Diagnostics (LymPro/ NuroPro ) Therapeutics (Eltoprazine/MANF) Discovery ( PhenoGuard ) Regen Med* (ESS) * = Upon Completion of the acquisition from Lonza Corporate infrastructure in place to absorb assets. For ESS - W, 1 - 2 key hires + CRO
Slide 9: ESS Pending Acquisition Summary
ESS Pending Acquisition Summary • Entered into an exclusive option agreement with Lonza Walkersville, to acquire Cutanogen Corporation (a subsidiary of Lonza) • Intent is to develop Engineered Skin Substitute – Walkserville (ESS - W) as a autologous skin replacement product for the treatment of Stag
Slide 10: Extensive Due Diligence Conducted
Extensive Due Diligence Conducted • AMBS team conducted 18 - months of due diligence • Engaged RDM (Rare Disease Management) for in - depth review and recommendations • Extensive review of all documents delivered by Lonza • Permaderm/ESS Product Profile, timeline, product history and comprehensive F
Slide 11: Overview
ESS - W Overview 11
Slide 12: Product Profile
ESS - W Product Profile • Tissue - engineered skin substitute prepared from autologous (patient’s own) skin cells having both epidermal and dermal layers. • Absorbable collagen and glycosaminoglycan (C - GAG) matrix populated with autologous epidermal keratinocytes and dermal fibroblasts. • Cells an
Slide 13: Permaderm/ESS Challenges
Permaderm/ESS Challenges • Non - compliance issues in earlier clinical studies. • Questionable credibility of data generated till date and unlikely that FDA will allow use clinical data • Clinical Hold by FDA • Regulatory pathway needs to be agreed • New clinical development to be conducted • Limite
Slide 14: Permaderm/ESS Challenges Represent Exciting Acquisition Opportunity
Permaderm /ESS Challenges Represent Exciting Acquisition Opportunity for AMBS • Non - compliance issues in earlier clinical studies. • Questionable credibility of data generated till date and unlikely that FDA will allow use clinical data • Clinical Hold by FDA • Regulatory pathway needs to be agree
Slide 15: Strong KOL Support
Strong KOL Support 15 Nicole S. Gibran, M.D., F.A.C.S. , a Professor of Surgery and Director of the University of Washington Medicine Regional Burn Center at Harborview Medical Center in Seattle, Washington, and a principle investigator for the upcoming Phase 2 ESS clinical study “Severe burns repre
Slide 16: Highlights
ESS - W Highlights • Initial Patient Population : 500 - 2000 patients per year – Cost of treatment per patient : $ 1 . 6 M – Cost of treatment with complications : $ 10 M+ • Market opportunity in US : $ 500 M+ • Studies partially funded by US Gov’t grant : AFIRM • Strong KOL support and involvement
Slide 17: Burn Overview
Burn Overview • Burns are a global public health problem, accounting for an estimated 265,000 deaths annually • In many high - income countries, burn death rates have been decreasing, and the rate of child deaths from burns is currently over 7 times higher in low - and middle - income countries than
Slide 18: USA Burn Market Statistics
USA Burn Market Statistics • Data from the National Center for Injury Prevention and Control in the US shows that each year 1 . 2 million people present with burn injuries • Moderate to severe burn injuries requiring hospitalization account for approximately 100 , 000 of these cases • TOTAL NUMBER O
Slide 19: Cost of Care - USA Burn Patients
Cost of Care - USA Burn Patients • For severe burn patients without complications, the cost of care tops $ 1 . 6 million • With complications, severe burn treatment cost is over $ 10 million to treat successfully • Overall, costs escalate for major burn cases because of repeated admissions for recon
Slide 20: Cost of Care - USA Burn Patients
Cost of Care - USA Burn Patients • Disfigurement, scarring, or contracture, occurring in 66 percent of cases, add $ 28 , 000 - 35 , 000 to treatment costs • Psychological complications, occurring in 57 percent of cases, add $ 16 , 000 - 75 , 000 to treatment costs • Fragile skin or skin breakdown, o
Slide 21: Competitive Product Analysis
Competitive Product Analysis • Skin substitutes are extensively used in burn wound management • An ideal product should offer quick replacement of both the lost epidermis and dermis layers of skin with permanent wound coverage • Other important factors in selection of a product are: cost effectivene
Slide 22: Opportunity Summary
ESS - W Opportunity Summary • Differentiated product fulfilling significant unmet needs and near - term commercial opportunity • Potential for meaningful revenue generation in the near - term • Providing life - saving solutions to patients and strong potential to play a key role in market • All hist
Slide 23: Near-Term Next Steps
Near - Term Next Steps • Finalize transaction with Lonza and Regenecin • Prepare to commence Phase 1/2a study • Conduct formal pricing and reimbursement study 23
Slide 24: ESS is Perfectly Aligned with AMBS Strategy
ESS - W is Perfectly Aligned with AMBS Strategy • AMBS has robust pipeline with high value product candidates from discovery to commercial - ready • Regenerative medicine space is “HOT” and attractive to Big Pharma – entry by acquisition • ESS provides yet another opportunity to unlock significant v
Slide 25: Robust Pipeline from Discovery to Commercial
Robust Pipeline from Discovery to Commercial has Potential to Unlock Significant Value in Near Term 25 Asset Pre - Clinical Phase 1 Phase 2 Phase 3 Commercial LymPro Test®: Alzheimer’s (CLIA) Potential spinoff in 2015 Eltoprazine: Parkinson’s / Adult ADHD Potential partnership in 2016 ESS - W*: Intr
Slide 26: AMBS Near-Term Milestones
AMBS Near - Term Milestones Eltoprazine • IND Submission/approval • Initiation of Eltoprazine Phase 2b clinical study in PD LID anticipated for early Q1/2015 • Initiation of the Phase 2b adult ADHD clinical trial with Eltoprazine anticipated for later in 2015 LymPro • Completion of enrollment in exp
Slide 27: AMBS Near-Term Milestones (Cont'd)
AMBS Near - Term Milestones (Cont’d) MANF • Response on Orphan Drug Designation Application for MANF in RP expected from FDA • Functional data in RP in animals • File RP ODD application in Europe • CRVO ODD at FDA ESS - W • Completion of transaction to acquire asset • Initiation of Phase 1/2a study
Slide 28: Q&A
Q&A 28
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