signatures amarantus bioscience holdings,...

18
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 3, 2015 AMARANTUS BIOSCIENCE HOLDINGS, INC. (Exact name of registrant as specified in its charter) Nevada 000-55016 26-0690857 (State or other jurisdiction of incorporation or organization) (Commission File Number) IRS Employer Identification No.) 655 Montgomery Street, Suite 900 San Francisco, CA 94111 (Address of Principal Executive Offices) (Zip Code) (408) 737-2734 (Registrant’s telephone number, including area code) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ¨ Written communications pursuant to Rule 425 under the Securities Act ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Upload: others

Post on 19-Apr-2020

3 views

Category:

Documents


0 download

TRANSCRIPT

UNITED STATES

SECURITIES AND EXCHANGE COMMISSIONWashington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 3, 2015

AMARANTUS BIOSCIENCE HOLDINGS, INC.(Exact name of registrant as specified in its charter)

Nevada 000-55016 26-0690857

(State or other jurisdiction of incorporation or organization)

(Commission File Number) IRS EmployerIdentification No.)

655 Montgomery Street, Suite 900

San Francisco, CA 94111(Address of Principal Executive Offices) (Zip Code)

(408) 737-2734

(Registrant’s telephone number, including area code)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant underany of the following provisions: ¨ Written communications pursuant to Rule 425 under the Securities Act ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01 Regulation FD Disclosure

Amarantus BioScience Holdings, Inc. (the “Company”) released a corporate presentation which it utilized during its AnnualMeeting in New York on August 3, 2015. The Company’s presentation is furnished hereto as Exhibit 99.1.

The information disclosed under this Item 7.01, including Exhibit 99.1 hereto, is being furnished and shall not be deemed “filed”

for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference into anyregistration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing. Item 8.01 Other Items

On August 3, 2015, the Company issued a press release announcing that its August 3, 2015 Annual Meeting was adjourned due tolack of a quorum. A copy of the Company’s press release is furnished hereto as Exhibit 99.2.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No. Description

99.199.2

PresentationAmarantus Bioscience Holdings, Inc. Press Release, dated August 3, 2015

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its

behalf by the undersigned thereunto duly authorized.

AMARANTUS BIOSCIENCE HOLDINGS, INC. Date: August 3, 2015 By: /s/ Gerald E. Commissiong Name: Gerald E. Commissiong Title: Chief Executive Officer

Exhibit 99.1

Ticker: OTCQX:AMBS www.amarantus.com Annual Meeting of Shareholders August 3, 2015

Forward - Looking Statements 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 Company to differ materially from the results expressed or implied by such statements, including changes from anticipated levels of sales, future international, national or regional economic and competitive conditions, changes in relationships with customers, access to capital, difficulties in developing and marketing new products and services, marketing existing products and services, customer acceptance of existing and new products and services and other factors. Accordingly, although the Company believes that the expectations reflected in such forward - looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company has no obligation to update the forward - looking information contained in this presentation. 2

AMBS Holding Company Business Model Fuels Rich Pipeline Our Vision : Identifying undervalued assets, de - risking and advancing to key value driving events: 3 ® ® Screening Expertise Neurological Disorders Parkinson’s Disease Adult ADHD Alzheimer’s Aggression Multiple Sclerosis Orphan Indications Retinitis Pigmentosa Intractable Severe Burns Therapeutics Therapeutics Diagnostics MANF MSPrecise Eltoprazine LymPro Georgetown Assay* MANF ESS *Upon exercise of exclusive option with Georgetown University

Building Value into Therapeutics Pipeline to Reach Transformational Milestones 4 Program Preclinical Phase 1 Phase 2 Phase3 Market ESS Intractable Severe Burns Eltoprazine Parkinson’s PD - LID Eltoprazine Adult ADHD Eltoprazine Alzheimer’s Aggression MANF Retinitis Pigmentosa MANF Parkinson’s Disease Pipeline addressing high - value, high need therapeutic areas with significant shortcomings

Recent ESS Acquisition to Add Significant Value • Autologous, skin graft replacement for 50 + % TBSA severe burns • Biologics/drug regulatory pathway in office of combination products • Orphan Drug Designation received in 2012 • Active IND as of May 2014 • Partially funded by US Gov’t grant : AFIRM • Project has been partially funded by DoD for last 5 + years • Strong KOL Support • Patient Population : ~ 2 , 000 average patients per year - Cost of treatment per patient : $ 1 . 6 M, w/ complications : $ 10 M+ • Secondary applications : pediatric burn 30 % + burns, diabetic foot ulcers, cosmetics • 10 patient Phase 2 clinical trial on track to commence 3 Q 2105 5

ESS: Recent Milestone Achievements x Completed acquisition of Cutanogen Corporation for exclusive rights to ESS x Preparation underway to commence Phase 2 study x First site initiation underway x Signed CRADA Agreement providing non - dilutive resources x Strong KOL support NEXT MILESTONES ▪ Initiate first site at military facility in 3Q 2015 ▪ Enroll first patent in Phase 2 study in 3Q 2015 ▪ Work with regulatory authorities with the goal of establishing accelerated path to commercialization ▪ Announce top - line results of Phase 2 study in 2016 6

Eltoprazine: Recent Milestone Achievements x Published Phase 2a clinical study results in BRAIN for the treatment of PD - LID x Opened an IND application with the neurology division of the FDA to advance Eltoprazine into Phase 2b clinical studies x Completed Investigator Meetings in US and EU x Entered into a clinical trial agreement with Chiltern International, a leading global contract research organization to manage the clinical research and monitoring program services for the Phase 2b study in PD - LID x Opened clinical trial sites in US x USPTO issued U.S. Patent entitled, "Pharmacological Treatment of Parkinson's Disease,” covering methods for the administration of eltoprazine , in combination with the anti - Parkinson's drug, levodopa (L - DOPA), for the treatment of Parkinson's disease x Commenced patient dosing of Phase 2b study NEXT MILESTONES ▪ Expand Phase 2b program in Europe ▪ Complete patient enrollment ▪ Report top - line results of Phase 2b program in 2H 2016 7

MANF: Recent Milestone Achievements x Announced the successful delivery and distribution of MANF in a preclinical model to brain areas involved in Parkinson's disease , further solidifying the rationale for its preclinical development as a potential disease - modifying treatment for PD x Entered into a cGMP manufacturing agreement with Catalent Biologics for clinical - grade production of MANF to enable program advancement into human clinical studies in retinitis pigmentosa (RP), retinal artery occlusion, glaucoma and Parkinson's disease x Presented positive preclinical data showing MANF preserves the light - sensing function of photoreceptor cells at ARVO x Received a Notice of Allowance for the U.S. patent application covering compositions of matter and methods of use related to proprietary manufacturing processes for synthetic MANF and its administration for protein therapy and cell therapy x Received European Union Orphan Drug Designation (ODD) for MANF for the treatment of RP, complementing the US ODD obtained in December 2014 x Significant progress with academic collaborators NEXT MILESTONES ▪ Commence first - in - human Phase 1 study in 2H 2016 ▪ Expand development program into additional high - value indications 8

Amarantus Diagnostics Preparing for Strategic Transaction • LymPro Test ® : O ptimizing IUO marketing and CLIA strategy • MSPrecise ® : Finalizing commercial strategy for staged product launch • Georgetown assays position to control significant market share in the emerging AD IUO blood diagnostics market 9 Finalize Negotiations Complete Partnerships • Proven track record of strategically extracting commercial profitability by advancing diagnostic products through a robust commercialization pathway • Driving strategy to mature the neuro - diagnostics business into a powerhouse in the life sciences industry LymPro Business Development Strategic Advisory Committee • 6 - 12 mos. sales cycle initiated November 2014 • BD Strategy to formalize IUO Agreements advancing • AAIC data strengthening discussions • Next: comparing LymPro results against PET Deriving full value from neuro - diagnostics business through potential sale, co - development or spinoff opportunities

Up - listing to NASDAQ is a Priority x Submitted the listing application x Currently completing the listing process x Awaiting a formal response from NASDAQ 10

Next Steps for Amarantus » Uplist to NASDAQ as rapidly as possible » Focus on Operational Excellence with therapeutic programs to advance to key data milestones » Complete strategic transaction with Amarantus Diagnostics 11 We are prepared to enter our next phase of growth!

Q&A 12

Ticker: OTCQX:AMBS www.amarantus.com Annual Meeting of Shareholders August 3, 2015

Exhibit 99.2

Amarantus Announces Adjournment of Annual Meeting

SAN FRANCISCO, CA, and GENEVA, SWITZERLAND – August 3, 2015 – Amarantus BioScience Holdings, Inc. (OTCQX: AMBS),a biotechnology company developing therapeutic and diagnostic product candidates in orphan indications and neurology, announced that its2015 Annual Meeting of Stockholders scheduled for, and convened on August 3, 2015, was adjourned due to the lack of requisite quorum.Only stockholders of record on the record date July 10, 2015 are entitled to and are being requested to vote. The annual meeting has been adjourned to August 7, 2015 at 10:00 a.m. EDT at Sichenzia Ross Friedman Ference LLP, 61 Broadway,32nd Floor, New York, New York 10006 to allow additional time for the stockholders to vote on the proposals set forth in the Company'sproxy statement filed with the Securities and Exchange Commission (“SEC”), which is available athttp://www.sec.gov/Archives/edgar/data/1424812/000114420415043459/v415847_def14a.htm. During the period of the adjournment, the Company will continue to solicit proxies from its stockholders with respect to the proposals setforth in the Company's proxy statement. Proxies previously submitted in respect of the meeting will be voted at the adjourned meetingunless properly revoked. The Company encourages all stockholders who have not yet voted to do so before August 6, 2015 at 11.59 p.m. EDT. The beneficialstockholders may vote by internet at www.proxyvote.com, or by telephone at 800-454-8683. Record holders may return a properlyexecuted proxy card to18 Lafayette Place, Woodmere, NY 11598 or they may vote by internet at www.vstocktransfer.com/proxy. No changes have been made in the proposals to be voted on by stockholders at the annual meeting. The Company's proxy statement andany other materials filed by the Company with the SEC remain unchanged and can be obtained free of charge at the SEC's website atwww.sec.gov. About Amarantus BioScience Holdings, Inc. Amarantus BioScience Holdings (OTCQX: AMBS) is a biotechnology company developing treatments and diagnostics for diseases in theareas of neurology and orphan diseases. AMBS’ Therapeutics division has development rights to eltoprazine, a small molecule currently ina Phase 2b clinical program for Parkinson's disease levodopa-induced dyskinesia with the potential to expand into adult ADHD andAlzheimer’s aggression. The Company has an exclusive worldwide license to intellectual property rights associated to Engineered SkinSubstitute (ESS), an orphan drug designated autologous full thickness skin replacement product in development for the treatment of severeburns currently preparing to enter Phase 2 clinical studies. AMBS owns the intellectual property rights to a therapeutic protein known asmesencephalic-astrocyte-derived neurotrophic factor (MANF) and is developing MANF as a treatment for orphan ophthalmic disorders,initially in retinitis pigmentosa (RP). AMBS also owns the discovery of neurotrophic factors (PhenoGuard™) that led to MANF’sdiscovery.

AMBS’ Diagnostics division owns the rights to MSPrecise®, a proprietary next-generation DNA sequencing (NGS) assay for theidentification of patients with relapsing-remitting multiple sclerosis (RRMS), and has an exclusive worldwide license to the LymphocyteProliferation test (LymPro Test®) for Alzheimer's disease, which was developed by Prof. Thomas Arendt, Ph.D., from the University ofLeipzig, and owns further intellectual property for the diagnosis of Parkinson's disease (NuroPro®). For further information please visit www.Amarantus.com, or connect with the Company on Facebook, LinkedIn, Twitter and Google+. Forward-Looking Statements Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans,objectives, and expected operating results, and the assumptions upon which those statements are based, are forward-looking statements.These forward-looking statements generally are identified by the words "believes," "project," "expects," "anticipates," "estimates,""intends," "strategy," "plan," "may," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actualresults to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans orstrategies is inherently uncertain. Factors which could have a material adverse effect on our operations and future prospects on aconsolidated basis include, but are not limited to: changes in economic conditions, legislative/regulatory changes, availability of capital,interest rates, competition, and generally accepted accounting principles. These risks and uncertainties should also be considered inevaluating forward-looking statements and undue reliance should not be placed on such statements. Investor and Media Contact:Jenene ThomasJenene Thomas Communications, LLCInvestor Relations and Corporate Communications AdvisorT: (US) 908.938.1475E: [email protected] Source: Amarantus Bioscience Holdings, Inc.