Probiodrug reports
full year 2015 financial results
Phase 2a study of novel treatment for Alzheimer's disease
initiated
Phase 1 PQ912 data, a first in
class Glutaminyl Cyclase (QC) inhibitor for the treatment of AD,
prominently published
Private Placement completed
raising EUR 13.5 million
HALLE/SAALE,
Germany, 15 March 2016 Probiodrug AG (Euronext Amsterdam: PBD),
a biopharmaceutical company developing novel therapeutic solutions
to treat Alzheimer's disease (AD), today announced its financial
results for the twelve-month period ending 31 December 2015
prepared in accordance with German GAAP ("HGB") and, on a voluntary
basis, in accordance with IFRS as endorsed by the European Union.
The Annual Reports are available on the company website
(http://www.probiodrug.de/investors/reports-and-presentations/).
KEY
HIGHLIGHTS
-
Phase 2a study of novel treatment for
Alzheimer's disease, the SAPHIR trial, initiated
-
Phase 1 PQ912 data, a first in class Glutaminyl
Cyclase (QC) inhibitor for the treatment of AD, published in
Alzheimer's & Dementia: Translational Research
& Clinical Interventions
-
Manufacturing process for PBD-C06, Probiodrug's
anti-pGlu-Abeta targeting antibody, initiated
-
Additional data on Glutaminyl Cyclases (QCs) in
Alzheimer's disease published in Acta
Neuropathologica
-
Data on Probiodrug's anti-pGlu-Abeta monoclonal
antibody presented at the 12th
AD/PDTM 2015, Nice,
France and at Neuroscience 2015, the 45th annual
meeting of the Society for Neuroscience (SfN) in Chicago, USA
-
Key patents on Glutaminyl Cyclase (QC)
inhibition for the treatment of AD and for Probiodrug's antibody
program targeting pGlu-Abeta granted in key territories
-
Several high-caliber academic collaborations
continued or initiated, e.g. with the Brigham and Women's Hospital,
affiliated with Harvard Medical School and with University of
Leipzig, Paul Flechsig Institute for Brain Research
-
Winner of the European Mediscience Award 2015
for Best Technology
-
Annual General Meeting held in June 2015, all
resolutions proposed by Management and Supervisory Board
approved
-
New members of the Supervisory Board with
distinguished industry expertise appointed
-
Private placement raising EUR 13.5 million
closed in November 2015
-
Cash and cash equivalents of EUR 21.4 million as
of 31 December 2015
-
Net loss of EUR 13.5 million compared with EUR
11.4 million in 2014 - in line with company expectations
POST PERIOD
HIGHLIGHTS
There were no significant events
subsequent to the reporting period.
CONFERENCE
CALL
Probiodrug will host a conference call open to the public today,
March 15th, at 15:00
Central European Time (CET); the presentation will also be posted
to the website. The conference will be held in English. To
participate in the conference call, please call one of the
following numbers ten minutes prior to commencement:
Please dial one of the following
access numbers, then enter the PIN Code: 26484450#
Country |
Toll-Free |
Toll/Local |
Austria |
0800301051 (EN)
0800301052 (DE) |
+4319280492 (EN)
+4319280494 (DE) |
Belgium |
|
+32 11500307 |
Canada
(Toronto) |
|
+1 4162164186 |
Finland |
0800523161 |
+35 8981710496 |
France |
0805110449 |
+33 170750705 |
Germany (Frankfurt) |
08006270715 |
+49 69222229043 (EN)
+49 69222229044 (DE) |
Luxemburg |
080040184 |
+35 227300157 |
Netherlands |
|
+31 107137273 |
Sweden |
0200883629 |
+46 850556469 |
Switzerland |
0800005200 (EN)
0800005205 (DE) |
+41 225805970 (EN)
+41 225805971 (DE) |
UK |
|
+44 2030092452 |
USA |
|
+1 8554027766 |
A Question and Answer session will
follow the presentation of results.
Commenting on the
results, Dr Konrad Glund, Chief Executive Officer of Probiodrug,
said: "In its first year as a listed company, Probiodrug
successfully continued to progress its innovative pGlu-Abeta
therapeutic approach and reached important milestones. The
start of the Phase 2 "SAPHIR" study of our lead product PQ912 for
treating Alzheimer's disease, the initiation of the manufacturing
process for our anti-pGlu-Abeta-antibody PBD-C06 and the
publication of crucial data of our programs represent significant
accomplishments. Our first private placement as a public company
was very successful - with the money raised we also welcomed new
bluechip investors. The achievements of 2015 would not have been
possible without the support, commitment and trust of our
employees, advisors, partners and shareholders - many thanks to all
of you for the achievements of 2015."
KEY FIGURES
(ACCORDING TO IFRS)
in EUR
k, unless otherwise stated |
2015 |
2014 |
Earnings, Financial and Net Assets
Position |
|
|
Revenues |
0 |
0 |
Operating loss |
-13,393 |
-11,267 |
Net
loss for the period |
-13,505 |
-11,437 |
Equity (end of the
year) |
16,133 |
15,971 |
Equity ratio (end of the year) (in %) |
73.8 % |
74.4 % |
Balance sheet total
(end of the year) |
21,866 |
21,480 |
Cash
flows used in operating activities (year) |
-12,147 |
-10,589 |
Cash flows used in
operating activities (average) |
-1,012 |
-882 |
Cash
flows provided by financing activities (net) |
12,598 |
25,762 |
Cash and cash
equivalents at the end of period |
21,361 |
20,920 |
|
|
|
Personnel |
|
|
Total number of
employees (incl. Board of management)
(end of the year) |
16 |
12 |
Average number of employees
(incl. Board of management) |
15.8 |
12.0 |
|
|
|
Probiodrug-Share |
|
|
Loss per share (basic
and diluted) (in EUR) |
-1.97 |
-2.35 |
Number of shares issued (end of the year) |
7,442 |
6,766 |
DETAILS OF THE
FINANCIAL RESULTS (ACCORDING TO IFRS)
Net
loss
The net loss amounts to EUR 13,505k (2014: EUR 11,437k), thereof
EUR 13,393k (2014: EUR 11,267k) are to be attributed to the
operating loss and EUR 112k (2014: EUR 170k) to the financial loss,
all in line with the expectations of Probiodrug. The operating loss
is primarily driven by the research and development expenses
amounting to EUR 10,158k (2014: EUR 8,008k) and to a lesser degree
by the general and administrative expenses of EUR 3,279k (2014: EUR
3,319k). The increase in research and development expenses reflects
primarily an increase in the purchased services within the scope of
the phase 2 clinical study.
Equity
The equity amounts to EUR 16,133k (2014: EUR 15,971k),
corresponding to an equity ratio of 73.8%.
Cash
Cash and cash equivalents were EUR 21,361k, compared with EUR
20,920k as at the end of 2014. As a result of the capital increase
in November 2015, net cash proceeds of EUR 12,598k were
realised.
Noncurrent/
current liabilities
The noncurrent liabilities amount to EUR 822k (2014: EUR 929k),
consisting completely of the net commitment (defined benefit
liability) of the pension commitments (defined benefit obligations)
of EUR 1,522k (2014: EUR 1,564k). The current liabilities amount to
EUR 4,911k (2014: EUR 4,580k), consisting primarily of the tax
liabilities of EUR 2,641k (comprising the Company's payment
obligations as a result of the tax audit for the period 2002
through 2005 including interest for late payment) and trade
payables. The trade payables amounted to EUR 1,629k (2014: EUR
1,036k) resulting from of the ordinary course of business. They
have a remaining term of up to one year.
OPERATIONAL
REVIEW
Pipeline
update
Probiodrug's development approach targets pyroglutamate-Abeta
(pGlu-Abeta, also called N3pG Abeta) as a therapeutic strategy to
fight Alzheimer's disease. This modified Abeta is considered to be
linked with disease initiation and progression by seeding the
formation of soluble neurotoxic amyloid oligomers. Probiodrug is
developing proprietary product candidates to target toxic
pGlu-Abeta via two modes of action: by (i) inhibiting the
production of pGlu-Abeta; and (ii) clearing existing pGlu-Abeta
from the brain.
Probiodrug's innovative approach
is based on the development of specific inhibitors for the enzyme
Glutaminyl Cyclase (QC), which is instrumental in the creation of
pGlu-Abeta. In addition, the company is developing a monoclonal
antibody targeting pGlu-Abeta to enhance its clearance.
To date, Probiodrug's pipeline
consists of two small molecule inhibitors of the QC-enzyme, PQ912
and PQ1565, and a monoclonal antibody, PBD-C06, targeting
pGlu-Abeta.
PQ912
In 2015, Probiodrug initiated a Phase 2a study, the "SAPHIR" study,
of its lead product candidate PQ912. In a preceding Phase 1 study
with healthy young and elderly volunteers, PQ912 was shown to be
safe and well tolerated and revealed high QC-inhibition.
PQ912 is the first QC-inhibitor
being tested in patients. The Phase 2a study is a randomized,
double-blind multi-center study which plans to enrol a total of 110
patients with early stage Alzheimer's disease. The study is led by
internationally renowned experts in AD in six European countries at
about 18 sites, with the Alzheimer Center, VU Medical Center
(VUmc), Amsterdam being the lead center. The primary endpoint of
the trial is the safety and tolerability of PQ912 compared with
placebo over a three-month treatment period. Additionally, a set of
exploratory read-outs comprising cognitive tests, functional
assessments by EEG and functional MRI and new molecular biomarkers
in CSF will be used to evaluate the compound's effect on the
pathology of the disease.
Patient enrolment started in March 2015.
SAPHIR is now in full swing. To
respond to several challenges such as high competition in getting
access to treatment naïve patients we have taken various measures,
in particular adding more sites in various countries while keeping
quality at high level. Additional sites are activated, all are
highly motivated and enrolling. Primary endpoint data are expected
to be available end of 2016, while the full picture of all
exploratory results are expected to be finally evaluated about 3 to
4 months thereafter.
PBD-C06
PBD-C06 is a monoclonal antibody, currently in preclinical stage.
PBD-C06 targets pGlu-Abeta, aiming to selectively clear the brain
of pGlu-Abeta while leaving non-toxic forms of Abeta untouched.
PBD-C06 has been successfully humanized and also de-immunized to
avoid detection by the patient's endogenous immune system. For the
first time for an anti-pGlu-Abeta approach PBD-C06 has not only
shown the ability to reduce Abeta/plaques but also to significantly
improve cognitive deficits in aged Alzheimer's mice. Moreover, no
evidence was found of increased microhemorrhages after treatment
with PBD-C06.
The manufacturing process of this
molecule started in October 2015.
PQ1565
PQ1565 is a QC-inhibitor, currently in preclinical stage. The
product candidate has shown attractive drug-like properties in
preclinical studies. The GMP process for this molecule is being
implemented.
Publications/
Presentations
In March 2015, additional data on Glutaminyl Cyclases (QCs) in its
relation to Alzheimer's disease was published in the journal
Acta Neuropathologica 2015 Apr, 129(4), Pages
565-83. The study provides further evidence of the strong
correlation between QCs and AD pathology in human brain biopsies
underlining QC-inhibition as a therapeutic approach.
Also in March 2015, Probiodrug
presented the poster "Anti-pGlu-3 Abeta mab ig isotype affects
plaque clearance" on its specific pGlu-Abeta mouse antibody 17/1 at
the 12th International Conference on Alzheimer's and Parkinson's
Diseases and Related Neurological Disorders (AD/PDTM 2015) in Nice,
France. The data resulted from a collaboration between Probiodrug
and the research team led by Professor Cynthia Lemere from the
Center for Neurologic Diseases at the Brigham and Women's Hospital
and Harvard Medical School, Boston, MA. The study addressed
specifically the effect of the antibody's Ig isotype on
microglia-mediated Abeta plaque clearance in an in-vitro
phagocytosis assay using brain tissues from 20-month-old APP dE9
mice. It was found that the mouse pGlu-Abeta IgG2a antibody was the
most efficient, followed by the mutated IgG2a form while the IgG1
was the least effective in clearing Abeta plaques.
In October 2015, Probiodrug during
an oral presentation entitled "Preclinical in vivo Effects of an
anti-PyroGlu-3 Abeta Antibody" presented data on its specific anti
pGlu-Abeta monoclonal antibody at Neuroscience 2015, the 45th
annual meeting of the Society for Neuroscience (SfN) in Chicago,
USA. The data presented resulted from a collaboration between
Probiodrug and the research team led by Associate Professor Cynthia
Lemere from the Center for Neurologic Diseases at the Brigham and
Women's Hospital and Harvard Medical School, Boston, USA. This was
the first report that an anti-pGlu-Abeta antibody approach not only
reduced Abeta/plaques but also significantly improved cognitive
deficits in aged Alzheimer's mice. Moreover no evidence was found
for increased microhemorrhages after treatment.
In December 2015, the data from an
extensive phase 1 study with PQ912, Probiodrug's lead QC inhibitor
for the treatment of AD, was published in Alzheimer's & Dementia: Translational Research &
Clinical Interventions, Volume 1, Issue 3 Pages 182-195. PQ912
is a first-in-class competitive inhibitor of Glutaminyl Cyclase,
essential for the formation of pyroglutamate-Amyloid-beta
(pGlu-Abeta). PGlu-Abeta seeds Abeta oligomers which, due to their
hypertoxicity, are regarded as the key culprits behind AD. In the
published data, over 200 young and elderly healthy volunteers were
included in a single-and multiple-ascending dose design. PQ912 was
found to be safe and well tolerated; the maximum tolerated dose was
not reached. The study also evaluated pharmacokinetic parameters of
the compound as well as the extent of QC inhibition in the cerebral
spinal fluid (CSF), which is a measure for QC-inhibition in the
brain. Based on the data obtained in CSF, the dose dependent target
inhibition could be reliably determined and was used for dose
selection in the current phase 2a trial. The study was conducted
with Covance in Switzerland and the UK.
Patents
In 2015, Probiodrug's IP position was further strengthened by
important patent applications being granted. These include:
-
Patent no. US 9,156,907 and JP 5,828,762,
covering method as well as composition of matter claims for
Probiodrug's antibody program targeting pGlu-Abeta, were granted in
the US and in Japan, respectively
-
Patent nos. JP 5690463, covering the use of QC
inhibitors for the treatment of Alzheimer's disease, JP 5688745,
covering a chemical space of heterocyclic QC inhibitors, and Patent
no. JP2007-508347A, covering the use of QC inhibitors for the
treatment of Familial British Dementia and Familial Danish
Dementia, were granted in Japan
-
Patent no. JP 5677297, covering Glutaminyl
Cyclase as a diagnostic/prognostic indicator for neurodegenerative
diseases, was granted in Japan.
CORPORATE
REVIEW
Execution of a
private placement
On November, 5, 2015 Probiodrug announced an increase in its share
capital from EUR 6,765,898 to EUR 7,442,487, by issuing 676,589 new
shares with a notional par value of EUR 1.00 per share generating
gross proceeds of EUR 13.5 million. The order book was well covered
based on strong demand from European and US investors. The new
shares were placed with selected qualified institutional investors
at a price of EUR 20 per share. The issued shares represented
approximately 10% of the Company's issued share capital at the time
of the placing.
Supervisory
Board
The general shareholder meeting on June, 10, 2015, elected Ms
Charlotte Lohmann and Mr Kees Been, two industry experts with an
extensive background in drug development and public markets
respectively, as new members of the Supervisory Board. Dr Hubert
Birner and Prof Georg Frank, who contributed significantly in
establishing Probiodrug as a successful public biopharmaceutical
company, did not apply for a new term. Probiodrug would like to
thank them again for their valuable contribution to the growth of
the company.
European
Mediscience Award for Best Technology 2015
In June 2015, Probiodrug won the 2015 European Mediscience Award
for Best Technology 2015. This Award is presented for an innovative
technology that is well funded and capable of significant
commercial success. The jury believed that Probiodrug was the clear
winner in this category, with its innovative and differentiated
approach to treating Alzheimer's disease and the Company's recent
achievements.
OUTLOOK
The mid-term focus of Probiodrug's
business activities can be summarised as follows:
-
Continue the clinical development of PQ912 in
particular generate initial patient study data and start long-term
treatment,
-
Completion of the production development of
PBD-C06 and conduction of regulatory tox as preparation for first
in man study,
-
Continuation of the development of PQ
1565,
-
Further scientific analysis of potential
additional indications for the use of QC inhibitors,
-
Continuation of work to better understand the
pGlu Abeta mediated pathologies,
-
Further increasing visibility and acceptance as
an important prerequisite for obtaining additional capital as well
as for an industrial transaction,
-
Further strengthening Probiodrug's financial
resources.
As a result of the additional
costs being incurred for development activities, the Company
estimates a net loss for the financial year 2016, which may be in
excess of that incurred in 2015.
ANNUAL FINANCIAL
REPORT 2015
Probiodrug has finalized its
financial statements for the year ended 31 December 2015 according
to German GAAP ("HGB") and IFRS. The auditor KPMG has issued an
unqualified auditors report for both statements. The reports are
available on the company website
(http://www.probiodrug.de/investors/reports-and-presentations/).
FINANCIAL
CALENDAR
12 May
2016 |
Interim Management Statement Q1 2016 |
19 May 2016 |
Annual General Meeting 2016 |
30 August 2016 |
Interim Report, Half Year Results 2016 |
10 November 2016 |
Interim Management Statement Q3 2016 |
###
For more
information please contact:
Probiodrug
Dr Konrad Glund, CEO
Email: contact@probiodrug.de
Hume
Brophy
Mary Clark, Supriya Mathur, Eva Haas
Tel: +44 (0) 207 862 6475
Email: probiodrug@humebrophy.com
The Trout
Group
Tricia Truehart
Tel: +1 646 378-2953
Email: ttruehart@troutgroup.com
Notes to
Editors:
About Probiodrug
AG
Headquartered in Halle, Germany, Probiodrug AG (Euronext Amsterdam:
PBD) is a biopharmaceutical company focused on the development of
new therapeutic products for the treatment of Alzheimer's
disease.
Founded in 1997, the company
successfully developed a novel therapeutic concept for diabetes -
the DP4 inhibitors - which provided the basis for a novel class of
antidiabetics - the gliptins. Its core capabilities are based on
its long-standing expertise in the elucidation of the structure and
function of enzymes involved in the modification of proteins and
peptides, which play a central role in pathological conditions.
Today Probiodrug's aim is to
become a leading company in the development of Alzheimer's disease
treatments and to thereby provide a better life for Alzheimer's
disease patients. It has identified a new therapeutic concept
linked to disease initiation and progression. The development
approaches are targeting pyroglutamate-Abeta (pGlu-Abeta) as a
therapeutic strategy to fight Alzheimer's disease. The Company has
medical use and composition of matter patents related to the
inhibition of Glutaminyl Cyclase (QC) and anti-pGlu-Abeta- specific
monoclonal antibodies, providing it, in the Company's view, with a
leading position in this field of research.
www.probiodrug.de
About Alzheimer's
disease
Alzheimer's disease is a neurological disorder, which is the most
common form of dementia, and ultimately leads to death. Because
Alzheimer's disease cannot be cured and is degenerative, the
affected patients must increasingly rely on others for assistance.
Today, over 46 million people worldwide currently live with the
condition and this number is expected to increase to 132 million by
2050. Alzheimer's also has an estimated, global societal cost of
US$ 818 billion (World Alzheimer Report 2015).
Forward Looking
Statements
Information set forth in this press release
contains forward-looking statements, which involve a number of
risks and uncertainties. The forward-looking statements contained
herein represent the judgment of Probiodrug AG as of the date of
this press release. Such forward-looking statements are neither
promises nor guarantees, but are subject to a variety of risks and
uncertainties, many of which are beyond our control, and which
could cause actual results to differ materially from those
contemplated in these forward-looking statements. We expressly
disclaim any obligation or undertaking to release publicly any
updates or revisions to any such statements to reflect any change
in our expectations or any change in events, conditions or
circumstances on which any such statement is based.