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 17, 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)) |
| Item 2.02 | Results of Operations and Financial Condition. |
On August 17, 2015, Amarantus Bioscience
Holdings, Inc. (the “Company”) issued a press release announcing financial results for the three months ended June
30, 2015 and other matters described in the press release. A copy of the Company’s press release is furnished as Exhibit 99.1
to this Current Report on Form 8-K.
The information disclosed under this Item 2.02,
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 any registration statement or
other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit
No. |
|
Description |
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99.1
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Amarantus Bioscience Holdings, Inc. Press Release,
dated August 17, 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. |
|
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Date: August 17, 2015 |
By: |
/s/ Gerald E. Commissiong |
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Name: Gerald E. Commissiong |
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Title: Chief Executive Officer |
|
Exhibit 99.1
Amarantus Reports Second Quarter 2015
Financial Results and
Business Overview
SAN FRANCISCO and GENEVA, Aug. 17, 2015 (GLOBE NEWSWIRE) --
Amarantus BioScience Holdings, Inc. (AMBS),
a biotechnology company developing therapeutic and diagnostic product candidates in orphan indications and neurology, announced
financial results for the second quarter ended June 30, 2015. The Company also highlighted recent corporate and clinical development
achievements for its Therapeutics Division and its wholly-owned subsidiary, Amarantus Diagnostics, Inc.
SECOND QUARTER 2015 AND RECENT HIGHLIGHTS
Corporate
| · | Commenced
trading on the OTCQX Marketplace as part of the
path to progress to a national stock exchange listing; |
| · | Completed
a capital restructuring in order to meet share
price requirements in preparation for a national exchange listing |
Amarantus Therapeutics
| · | Engineered Skin Subsitute (ESS): Autologous full thickness skin
replacement product for severe burns |
| o | Signed a Cooperative Research
and Development Agreement (CRADA) with the U.S. Army Institute of Surgical Research and
Rutgers, The State University of New Jersey to expand the
development of ESS for the treatment of deep partial- and full-thickness burn wounds
in adult patients (ClinicalTrials.gov Identifier: NCT01655407); |
| o | Completed the acquisition
of Cutanogen Corporation from Lonza Walkersville, Inc. (Lonza), a subsidiary of Lonza
Group Ltd., thereby securing full ownership and exclusive
worldwide license to intellectual property rights associated with ESS; and |
| o | Engaged Lonza via a long-term
services agreement to manufacture ESS under Good Manufacturing
Practices for human clinical trials, and subsequent commercial distribution. |
| · | Eltoprazine: Parkinson's disease levodopa-induced dyskinesia (PD-LID),
adult ADHD, and Alzheimer's aggression |
| o | Commenced
enrollment and initiated dosing in
the Phase 2b multi-center, 60-subject, double-blind, placebo-controlled, four-way crossover,
dose range finding clinical study for the treatment of PD-LID (ClinicalTrials.gov Identifier:
NCT02439125); |
| o | Announced the publication
of data on long-term efficacy and elucidating the mechanism
of action of eltoprazine in an animal model of PD-LID; |
| o | Announced the issuance
of the U.S. patent covering proprietary methods of administration for eltoprazine
for the treatment of Parkinson's disease; |
| o | Presented data
from the Phase 1/2a clinical study of eltoprazine in PD-LID at the 19th International
Congress of Parkinson's Disease and Movement Disorders; and |
| o | Completed Phase 2b clinical
investigator meetings in both the United States and European Union. |
| · | MANF: Mesencephalic-astrocyte-derived neurotrophic factor |
| o | 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 development as a potential disease-modifying treatment for PD; |
| o | 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 and Parkinson's disease; |
| o | Presented positive preclinical
data showing MANF preserves the light-sensing function of
photoreceptor cells at the leading ophthalmology conference ARVO 2015; |
| o | 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; and |
| o | Received European
Union Orphan Drug Designation (ODD) for MANF for the treatment of RP, complementing
the U.S. ODD obtained in December 2014. |
"The completion of the acquisition of Cutanogen from Lonza
this quarter is a significant milestone for Amarantus Therapeutics. ESS is a potentially revolutionary solution for the treatment
of severe burns that has demonstrated initial human proof-of-concept in an investigator-initiated setting," commented Joseph
Rubinfeld, Ph.D., member of the Amarantus Board Directors. "Our collaboration with the U.S. Army is an important part of the
expansion plan for the clinical development program of ESS. We expect to focus on the regulatory strategy for ESS in the weeks
ahead."
Amarantus Diagnostics, Inc. (a wholly owned subsidiary
of Amarantus BioScience Holdings, Inc.)
| · | Established
a Strategic Advisory Committee for Amarantus Diagnostics
comprising three seasoned, results-driven life science and healthcare industry
leaders with expertise in commercializing molecular diagnostics to focus on advancing
and deriving the full value of the company's diagnostics business. |
| · | LymPro Test(R) for the diagnosis of Alzheimer's disease
(AD) |
| o | Presented data
demonstrating that LymPro met primary and secondary endpoints in the blinded, multi-center
LP-002 clinical study that confirms LymPro's Fit-For-Purpose use in AD Clinical
Trials at the 2015 Alzheimer's Association International Conference(R); and |
| o | Advanced business development
activities with the pharmaceutical industry for Investigational Use Only (IUO) LymPro
Test biomarker services. |
| · | MSPrecise(R) for the diagnosis of multiple sclerosis
(MS) |
| o | Published data in the
Journal GENE from a clinical study demonstrating that MSPrecise
supports identification of multiple sclerosis patients with 84% accuracy and performs
well in identifying MS among a broad cohort of potential neurological diseases;
and |
| o | Reported preliminary data
from a blood-based version of MSPrecise showing it has statistically
significant sensitivity and specificity for classifying presentation of MS. |
| · | Georgetown Assays for the diagnosis of AD |
| o | Continued to explore the
potential of the emerging AD IUO blood diagnostics market through the one-year, exclusive
option agreement with Georgetown University to license patent rights for blood
based biomarkers for AD and memory loss. |
"The addition of ESS to our product portfolio adds a first-in-class
regenerative medicine platform to our pipeline. The advancement of Eltoprazine into Phase 2b clinical development represents a
significant achievement as we establish clinical and regulatory excellence at Amarantus Therapeutics," added David A. Lowe,
Ph.D., member of the Amarantus Board of Directors. "As we round out 2015 we expect to see additional momentum in our strategy
for Amarantus Diagnostics under the guidance of our newly appointed Strategic Advisory Committee tasked with realizing the full
value from our neuro-diagnostics business."
EXPECTED NEAR-TERM MILESTONES
| · | Obtain an up-listing to a national stock exchange to position the
Company for an appreciation in value and enabling the expansion of its current shareholder base; |
| · | Initiate the U.S. military study under the ESS CRADA at the first
surgical facility site; |
| · | Enroll the first patent in the Phase 2 study of ESS for the treatment
of severe burns; |
| · | Accelerate the path to commercialization for ESS by establishing a
dialogue with regulatory authorities before the end of 2015; |
| · | Announce top-line results from the ESS Phase 2 severe burn study in
2016; |
| · | Expand the eltoprazine Phase 2b program in PD-LID in Europe in 3Q
2015; |
| · | Complete patient enrollment for the ongoing Phase 2b study in 1Q 2016; |
| · | Report topline results from the Phase 2b clinical study of eltoprazine
in PD-LID in 1H 2016; |
| · | Submit an IND application for MANF for the treatment of retinitis
pigmentosa; |
| · | Continue to advance pre-clinical studies for MANF in other orphan
ophthalmological indications and Parkinson's disease; |
| · | Advance MSPrecise and the LymPro Test into CLIA validation studies
in parallel later this year in preparation for launch under CLIA designation to market to the broader medical community in the
United States; and |
| · | Execute one of the strategic options for the Amarantus Diagnostics,
including a potential sale, co-development or spin-off opportunities, to derive the significant value from the Company's premier
neuro-diagnostics business. |
"The company has evolved significantly over the course
of the past year with the expansion and advancement of our therapeutics pipeline and the continued traction towards commercialization
with Amarantus Diagnostics. This progress has been integral in enabling us to build a strong foundation for the company to advance
to our next stage of growth," added Gerald E. Commissiong, President & CEO of Amarantus Bioscience Holdings. "We
have taken several important steps to prepare the company for an uplisting on a national exchange. We continue working in earnest
to achieve that goal as quickly as possible as it remains the priority and focus of our team, and we intend to continue to engage
the NASDAQ Capital Market to complete this important objective."
SECOND QUARTER 2015 FINANCIAL SUMMARY
Research and development costs for the three months ended June
30, 2015 increased $617,000 to $2,257,000 from $1,640,000 for the three months ended June 30, 2014, primarily due to increase in
clinical related costs and research arrangements.
General and administrative expenses increased $1,238,000 to
$3,339,000 for the three months ended June 30, 2015 from $2,101,000 for the three months ended June 30, 2014, primarily due to
increased spending on Lonza Option payments, acquisition costs and other professional services, including consulting costs.
For the three months ended June 30, 2015, other income (expense)
decreased $158,000 to an expense of $126,000 from $284,000 in three month period ended June 30, 2014. Interest expense increased
from the prior year quarter $55,000 and change in fair value of warrant and derivative liability decreased $193,000.
Net loss for the three months ended June 30, 2015 was $5,722,000
as compared to a net loss of $4,025,000 for the three month period ended June 30, 2014 with the increase in loss driven by research
and development expense, consulting, Lonza Option payments, professional services and acquisition costs.
For the six months ended June 30, 2015 research and development
costs increased $2,577,000 to $4,734,000 from $2,157,000 for the six months ended June 30, 2014, primarily due to increase in clinical
related costs and research arrangements.
General and administrative expenses increased $4,180,000 to
$7,400,000 for the six months ended June 30, 2015 from $3,220,000 for the six months ended June 30, 2014 primarily due to increased
spending on consulting, Lonza Option payments, acquisition costs and other professional services.
For the six months ended June 30, 2015, other income (expense)
decreased $4,022,000 to an expense of $168,000 from $4,190,000 in the six month period ended June 30, 2014. Interest expense and
loss on issuance of warrants decreased $541,000 and $3,867,000, respectively. Change in fair value of warrant and derivative liability
increased $473,000 to $0 for the six months ended June 30, 2015.
Net loss for the six months ended June 30, 2015 was $12,302,000
as compared to a net loss of $9,567,000 for the six month period ended June 30, 2014 with the increase in loss driven by research
and development expense, consulting, Lonza Option payments, professional services and acquisition costs.
As of June 30, 2015, the Company had total current assets of
$784,000 consisting of $315,000 in cash and cash equivalents and $386,000 in prepaid expenses and other current assets, and $83,000
in deferred funding fees.
Amarantus Bioscience Holdings, Inc
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(in thousands, except share and per share
data)
| |
June 30, 2015 | | |
December 31, 2014 | |
ASSETS | |
| (Unaudited) | | |
| (Audited) | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 315 | | |
$ | 214 | |
Deferred financing fees | |
| 83 | | |
| — | |
Prepaid expenses and other current assets | |
| 386 | | |
| 198 | |
Total current assets | |
| 784 | | |
| 412 | |
Restricted cash | |
| 204 | | |
| 204 | |
Property and equipment, net | |
| 150 | | |
| 145 | |
Intangible assets, net | |
| 10,245 | | |
| 1,497 | |
Total assets | |
$ | 11,383 | | |
$ | 2,258 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 4,729 | | |
$ | 3,502 | |
Accounts payable - Regenicin | |
| — | | |
| 2,550 | |
Related party liabilities and accrued interest | |
| 255 | | |
| 252 | |
Accrued interest | |
| 139 | | |
| 25 | |
Note Payable | |
| 2,850 | | |
| — | |
Total current liabilities | |
| 7,973 | | |
| 6,329 | |
Total liabilities | |
| 7,973 | | |
| 6,329 | |
| |
| | | |
| | |
Stockholders’ equity (deficit) | |
| | | |
| | |
Convertible preferred stock, $0.001 par value, 10,000,000 shares authorized: | |
| | | |
| | |
Series A, $0.001 par value, 250,000 shares designated, -0- shares issued and outstanding as of June 30, 2015 and December 31, 2014 | |
| — | | |
| — | |
Series B, $0.001 par value, 3,000,000 shares designated, -0- shares issued and outstanding as of June 30, 2015 and December 31, 2014 | |
| — | | |
| — | |
Series C, $0.001 par value, 750,000 shares designated, 750,000 shares issued and outstanding as of June 30, 2015 and December 31, 2014 | |
| 1 | | |
| 1 | |
Series D, $1,000 stated value; 1,300 shares designated; 350 and 1,299 issued and outstanding as of June 30, 2015 and December 31, 2014, respectively; aggregate liquidation preference of $350 | |
| 315 | | |
| 1,169 | |
Series E, $1,000 stated value; 13,335 shares designated, 7,722 and 4,500 issued and outstanding as of June 30, 2015 and December 31, 2014 respectively; aggregate liquidation preference of $7,722 | |
| 6,950 | | |
| 4,050 | |
Series G, $5,000 stated value; 10,000 shares designated; 1,087 and 0 issued and outstanding as of June 30, 2015 and December 31, 2014, respectively; aggregate liquidation preference of $5,435 | |
| 4,950 | | |
| — | |
Common stock, $0.001 par value, 13,333,333 authorized; 7,084,970 and 5,614,605 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively | |
| 7 | | |
| 6 | |
Additional paid-in capital | |
| 62,637 | | |
| 45,886 | |
Accumulated deficit | |
| (71,450 | ) | |
| (55,183 | ) |
Total stockholders' equity (deficit) | |
| 3,410 | | |
| (4,071 | ) |
Total liabilities and stockholders' equity (deficit) | |
$ | 11,383 | | |
$ | 2,258 | |
Amarantus Bioscience Holdings, Inc
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except share and per share
data)
| |
Three Months Ended June 30, 2015 | | |
Three Months Ended June 30, 2014 | | |
Six Months Ended June 30, 2015 | | |
Six Months Ended June 30, 2014 | |
| |
| | |
| | |
| | |
| |
Net sales | |
$ | — | | |
$ | — | | |
$ | — | | |
$ | — | |
| |
| | | |
| | | |
| | | |
| | |
Operating expense: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 2,257 | | |
| 1,640 | | |
| 4,734 | | |
| 2,157 | |
General and administrative | |
| 3,339 | | |
| 2,101 | | |
| 7,400 | | |
| 3,220 | |
| |
| | | |
| | | |
| | | |
| | |
| |
| 5,596 | | |
| 3,741 | | |
| 12,134 | | |
| 5,377 | |
| |
| | | |
| | | |
| | | |
| | |
Loss from operations | |
| (5,596 | ) | |
| (3,741 | ) | |
| (12,134 | ) | |
| (5,377 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest expense | |
| (126 | ) | |
| (71 | ) | |
| (168 | ) | |
| (709 | ) |
Loss on issuance of common stock | |
| — | | |
| — | | |
| — | | |
| (67 | ) |
Loss on issuance of warrants | |
| — | | |
| — | | |
| — | | |
| (3,867 | ) |
Other expense | |
| — | | |
| (20 | ) | |
| — | | |
| (20 | ) |
Change in fair value of warrant & derivative liabilities | |
| — | | |
| (193 | ) | |
| — | | |
| 473 | |
| |
| | | |
| | | |
| | | |
| | |
Total other income (expense) | |
| (126 | ) | |
| (284 | ) | |
| (168 | ) | |
| (4,190 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net loss | |
$ | (5,722 | ) | |
$ | (4,025 | ) | |
$ | (12,302 | ) | |
$ | (9,567 | ) |
| |
| | | |
| | | |
| | | |
| | |
Preferred stock dividend | |
$ | 3,187 | | |
$ | 26 | | |
$ | 4,016 | | |
$ | 52 | |
Net loss attributable to common stockholders | |
$ | (8,909 | ) | |
$ | (4,051 | ) | |
$ | (16,318 | ) | |
$ | (9,619 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted net loss per common share | |
$ | (1.08 | ) | |
$ | (0.83 | ) | |
$ | (2.13 | ) | |
$ | (2.11 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic and diluted weighted average common shares outstanding | |
| 8,230,225 | | |
| 4,893,491 | | |
| 7, 652,163 | | |
| 4,551,050 | |
About Amarantus BioScience Holdings,
Inc.
Amarantus BioScience Holdings (OTCQX: AMBS)
is a biotechnology company developing treatments and diagnostics for diseases in the areas of neurology and orphan diseases. AMBS’
Therapeutics division has development rights to eltoprazine, a small molecule currently in a Phase 2b clinical program for Parkinson's
disease levodopa-induced dyskinesia with the potential to expand into adult ADHD and Alzheimer’s aggression. The Company
has an exclusive worldwide license to intellectual property rights associated to Engineered Skin Substitute (ESS), an orphan drug
designated autologous full thickness skin replacement product in development for the treatment of severe burns currently preparing
to enter Phase 2 clinical studies. AMBS owns the intellectual property rights to a therapeutic protein known as mesencephalic-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’s discovery.
AMBS’ Diagnostics division owns the
rights to MSPrecise®, a proprietary next-generation DNA sequencing (NGS) assay for the identification of patients
with relapsing-remitting multiple sclerosis (RRMS), and has an exclusive worldwide license to the Lymphocyte Proliferation test
(LymPro Test®) for Alzheimer's disease, which was developed by Prof. Thomas Arendt, Ph.D., from the University of
Leipzig, 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 actual results to differ materially from
the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently
uncertain. Factors which could have a material adverse effect on our operations and future prospects on a consolidated 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 in evaluating
forward-looking statements and undue reliance should not be placed on such statements.
Investor and Media Contact:
Jenene Thomas
Jenene Thomas Communications, LLC
Investor Relations and Corporate Communications
Advisor
T: (US) 908.938.1475
E: jenene@jenenethomascommunications.com
Source: Amarantus Bioscience Holdings,
Inc.
###
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