Probiodrug reports
financial results for H1 2016
HALLE (SAALE),
Germany, 30 August 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 first six months ending 30
June 2016, prepared in accordance with German GAAP ("HGB") and, on
a voluntary basis, in accordance with IFRS as endorsed by the
European Union. The reports are available on the company website
(http://www.probiodrug.de/investors/reports-and-presentations/).
KEY HIGHLIGHTS
-
Announcement of favourable results of chronic
toxicology studies with PQ912, Probiodrug's 'first- in-class'
Glutaminyl Cyclase (QC) inhibitor for the treatment of AD
-
Annual Shareholders' Meeting held on 19 May
2016
-
Key patents for Probiodrug's pGlu-Abeta
targeting monoclonal antibody program for the treatment of AD
granted in the US and Japan
-
Two key patents on Glutaminyl Cyclase (QC)
inhibition for the treatment of AD granted in Japan
-
Probiodrug's pGlu-Abeta approaches presented at
the 14th AAT Symposium on Advances in Alzheimer Therapy in Athens,
Greece
-
Probiodrug and Crossbeta Biosciences entered
into a partnership in the field of AD biomarkers
-
Probiodrug presented two posters at the 1st
Meeting of the newly founded Society for CSF Analysis and Clinical
Neurochemistry in Gothenburg, Sweden
-
Expenditures and corresponding cash position in
line with management expectations
-
As of 30 June 2016, Probiodrug held EUR 14.2
million in cash and cash equivalents
POST PERIOD HIGHLIGHTS
At the Alzheimer's Association
International Conference 2016 (AAIC) held in Toronto in July 2016,
Eli Lilly presented data from a patient trial of LY3002813, its
antibody targeting pGlu-Abeta. LY3002813 (also referred to as N3pG)
significantly reduced Abeta plaques by approximately 40% at the
highest dose of 10mg/kg, while lower doses were ineffective. These
results represent the first patient data from an approach targeting
pGlu-Abeta and provide encouraging support for the emerging anti
pGlu-Abeta field. Eli Lilly has meanwhile advanced LY3002813 into a
patient study with longer treatment duration (NCT02624778).
Probiodrug announced changes to
the Supervisory Board and Executive Management. Olivier Litzka,
partner at Edmond de Rothschild Investment Partners (EdRIP) and
member of the Supervisory Board since October 2009, will step down
effective 12 September 2016. Mark Booth, Chief Business Officer has
left the company for personal reasons as of 15 August 2016 and his
responsibilities taken up by Dr Konrad Glund, CEO.
CONFERENCE CALL
Probiodrug will host a conference
call open to the public today at 15:00 Central European Summer Time
(CEST)/ 09:00 Eastern Daylight Time (EDT); 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 your PIN Code:
19299710#
A Question & Answer session will follow the presentation of
results.
Dial in coordinates
Country |
Toll-free |
Toll/Local |
Austria |
0800301051(EN)
0800301052(DE) |
+4319280492 (EN)
+4319280494 (DE) |
Belgium |
|
+3211500307 |
Canada
(Toronto) |
|
+14162164186 |
Finland |
0800523161 |
+358981710496 |
France |
0805110449 |
+33170750705 |
Germany (Frankfurt) |
08006270715 |
+4969222229043 (EN)
+4969222229044 (DE) |
Luxemburg |
080040184 |
+35227300157 |
Netherlands |
|
+31107137273 |
Sweden |
0200883629 |
+46850556469 |
Switzerland |
0800005200(EN)
0800005205(DE) |
+41225805970 (EN)
+41225805971 (DE) |
United
Kingdom |
|
+442030092452 |
USA |
|
+18554027766 |
Commenting on the
results, Dr Konrad Glund, Chief Executive Officer of Probiodrug
said:
"In the first half of 2016,
Probiodrug has accomplished important milestones in the development
of its programs, targeting pGlu-Abeta in order to treat AD. We
concluded the assessment of the results of the chronic toxicology
studies with PQ912, our lead QC inhibitor. The results confirm the
comfortable safety profile of PQ912, thereby providing an important
de-risking event for our lead molecule. They also represent the
regulatory prerequisite for long treatment clinical studies in AD
patients. With key patents granted in major territories, we
continue to make progress in further securing and broadening a
robust IP estate around our programs in AD.
"Furthermore, the collaboration
with Crossbeta provides Probiodrug with a unique technology for
validating sensitive and specific assays for Abeta- and
pGlu-Abeta-oligomers to be used in the clinical studies of
Probiodrug's lead candidate, QC inhibitor PQ912.
"Finally, Eli Lilly presented
results from its anti pGlu-Abeta antibody at the AAIC in July,
where we saw for the first time clinical data from an approach
targeting pGlu-Abeta. These results provide encouraging support for
the field pursuing anti pGlu-Abeta approaches as a promising
strategy for AD."
KEY FIGURES (ACCORDING TO
IFRS)
|
Jan - June 2016 |
Jan - June 2015 |
Jan - Dec 2015 |
In EUR k,
unless otherwise stated |
|
|
|
Earnings, Financial and Net Assets
Position |
|
|
|
Revenues |
|
0 |
0 |
Operating loss |
-5,987 |
-6,177 |
-13,393 |
Net loss for the
period |
-6,044 |
-6,233 |
-13,505 |
Equity (end of the reporting period) |
10,465 |
10,160 |
16,133 |
Equity ratio (end of
the reporting period) (in %) |
66.6% |
66.0
% |
73.8
% |
Balance sheet total (end of the reporting period) |
15,740 |
15,383 |
21,866 |
Cash flows from
operating activities (cum.) |
-7,000 |
-6,119 |
-12,147 |
Cash
flows from operating activities (monthly average) |
-1,167 |
-1,020 |
-1,012 |
Cash flows from
financing activities (net) |
0 |
0 |
12,598 |
Cash
and cash equivalents at the end of the reporting period |
14,245 |
14,793 |
21,361 |
|
|
|
|
Personnel |
|
|
|
Total number of
employees (incl. Board of management) (end of the reporting
period) |
16 |
16 |
16 |
|
|
|
|
Probiodrug-Share |
|
|
|
Loss per share
(basic/diluted) (in EUR) |
-0,81 |
-0.92 |
-1.97 |
Number of shares issued (end of the reporting period) |
7,442 |
6,766 |
7,442 |
DETAILS OF THE FINANCIAL RESULTS
(ACCORDING TO IFRS)
The comparison figures for the
first six months 2016 shown below refer to the corresponding 2015
numbers.
Net loss
The net loss amounts to EUR 6,044k (Jan - June 2015: EUR 6,233k),
thereof EUR 5,987k (Jan - June 2015: EUR 6,177k) are to be
attributed to the operating loss and EUR 57k (Jan - June 2015: EUR
56k) to the financial loss, all in line with the expectations of
Probiodrug. The operating loss is primarily driven by research and
development expenses amounting to EUR 4,711k (Jan - June 2015:
EUR 4,511k) and to a lesser degree by the general and
administrative expenses of EUR 1,325k (Jan - June 2015: EUR
1,872k). The slight increase in research and development expenses
reflects primarily the development activities of PQ912. The
decrease in the general and administrative expenses results mainly
from lower administration expenses after the implementation of post
listing requirements in 2015.
Equity
As of 30 June 2016, the equity amounts to EUR 10,465k (as of 31
December 2015: EUR 16,133k), corresponding to an equity ratio of
66.6% (as of 31 December 2015: 73.8%).
Cash
Cash and cash equivalents were EUR 14,245k compared with EUR
21,361k as of 31 December 2015.
Noncurrent/ current
liabilities
The noncurrent liabilities amount to EUR 820k (as of 31 December
2015: EUR 822k), consisting completely of the net commitment
(defined benefit liability) of the pension commitments. The current
liabilities amount to EUR 4,454k (as of 31 December 2015: EUR
4,911k), consisting mainly of the tax liabilities of EUR 2,691k (as
of 31 December 2015: EUR 2,641k), comprising the Company's
(disputed) 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 1,386k (as
of 31 December 2015: EUR 1,629k) 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 program 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 essential for 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
Probiodrug is currently running 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 seven European countries
at about 20 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.
SAPHIR is in full swing. Headline
data are expected to be available end of 2016, while the full
picture of all exploratory results are expected to be finally
evaluated about three to four 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. This is in line with findings obtained with the
murine version mE8 of Eli Lilly's pGlu-Abeta specific antibody in
mice which they were able to confirm in patients.
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
ongoing.
CORPORATE REVIEW
Annual Shareholders' Meeting
2016
On 19 May 2016, Probiodrug held its 2016 Annual Shareholders'
Meeting. All resolutions proposed by the Company's Management and
Supervisory Board were approved at the meeting, including:
-
Adoption of a resolution to approve the actions
of the management board members for the financial year 2015
-
Adoption of a resolution to approve the actions
of the supervisory board members for the financial year 2015
-
Election of the financial statements auditor for
the financial year 2016
-
Elections of the supervisory board
-
Remuneration of the supervisory board
-
Adoption of a resolution to increase the
Authorized Capital 2014 as well as the corresponding amendments to
the articles of association
-
Adoption of a resolution on the adjustment of
the Stock Option Program 2014 and the Conditional Capital 2014/I as
well as the corresponding amendments to the articles of
association
-
Adoption of a resolution on the extension of the
exercise periods for the Option Programs 2007/2008 and 2010
Supervisory Board
Dr Erich Platzer, Dr Dinnies von der Osten, Dr Jörg Neermann and Dr
Olivier Litzka were re-elected as members of the Supervisory Board,
with Dr Platzer being appointed as chairman and Dr von der Osten
being appointed as vice-chairman.
OUTLOOK
The mid-term focus of Probiodrug's
business activities can be summarised as follows:
-
Further preclinical and clinical testing of the
development candidate PQ912, in particular completion of the first
patient study in a Phase 2a trial in 2017 and the evaluation and
design of a long -term treatment.
-
Compiling further supporting data and securing
intellectual property protection for the therapeutic concept of QC
inhibition as a novel approach for the treatment of AD and other
diseases.
-
Further progression of the development of the
anti pGlu-Abeta specific antibody (PBD-CO6) as well as of
PQ1565.
-
Progressing preclinical studies to further
evaluate the potential of Probiodrug's therapeutic candidates in
combinations for the treatment of AD and for use in other
indications.
FINANCIAL
STATEMENTS
January to June 2016
Probiodrug has finalized its
financial statements for the first six months 2016 according to
German GAAP ("HGB") and IFRS. The auditor KPMG has reviewed the
IFRS statements. The reports are available on the company website
(http://www.probiodrug.de/investors/reports-and-presentations/).
Financial calendar 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 (Saale), 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.