Amarantus BioScience Holdings, Inc. (OTCQX: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
- 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);
- 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
- 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
- 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);
- Announced the publication of data on long-term efficacy and
elucidating the mechanism of action of eltoprazine in an animal
model of PD-LID;
- Announced the issuance of the U.S. patent covering proprietary
methods of administration for eltoprazine for the treatment of
Parkinson's disease;
- 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
- Completed Phase 2b clinical investigator meetings in both the
United States and European Union.
- MANF: Mesencephalic-astrocyte-derived neurotrophic factor
- 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;
- 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;
- Presented positive preclinical data showing MANF preserves the
light-sensing function of photoreceptor cells at the leading
ophthalmology conference ARVO 2015;
- 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
- 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® for the diagnosis of Alzheimer's disease (AD)
- 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®; and
- Advanced business development activities with the
pharmaceutical industry for Investigational Use Only (IUO) LymPro
Test biomarker services.
- MSPrecise® for the diagnosis of multiple sclerosis (MS)
- 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
- 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
- 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, |
December 31, |
|
2015 |
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 |
Three Months |
Six Months |
Six Months |
|
Ended |
Ended |
Ended |
Ended |
|
June 30, 2015 |
June 30,
2014 |
June 30, 2015 |
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.
CONTACT: 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
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