Probiodrug Reports
Financial Results for H1 2018 and Corporate Update
HALLE (SAALE),
Germany, 30 August 2018 - Probiodrug AG (Euronext
Amsterdam: PBD), a clinical stage biopharmaceutical company
developing novel therapeutic solutions to treat
Alzheimer's disease (AD), today announces its financial
results for the first six months of 2018 ending June 30. The full
interim report is available on the company website
(http://www.probiodrug.de/investors/reports-and-presentations/).
KEY HIGHLIGHTS
-
Inhibition of Glutaminyl Cyclase as a new
treatment concept for Alzheimer's disease presented at the
255th ACS National
Meeting & Exposition in New Orleans, USA, in March 2018
-
Detailed study design of PQ912 Phase 2b core
program outlined on April 3, 2018
-
Dr. Ulrich Dauer appointed as Chief Executive
Officer as of May 1, 2018
-
Positioning of anti-pGlu-Abeta antibody PBD-C06
in the field of Abeta antibodies published in co-authored review
publication on June 16, 2018
-
Expenditures and corresponding liquidity
position (June 30, 2018: EUR 6.7 million) in line with management
expectations
Commenting on the
results, Dr. Ulrich Dauer, Chief Executive Officer of Probiodrug,
said:
"During the first six months of 2018 we focused on further refining
the development strategy for a Phase 2b program of our lead
candidate, PQ912. Dr. Inge Lues, her team and our world leading
external key opinion leaders, Philip Scheltens and Howard Feldman,
have outlined a unique study design according to latest FDA and EMA
regulatory guidelines and state of the art scientific
concepts. The study protocol is nearing completion, and after
successful financing of the company, we will be able to commence
treating initial patients. I am convinced that Probiodrug, with its
unique QC inhibition approach, represents great potential for both
its shareholders and the treatment of Alzheimer's disease."
FINANCIAL REVIEW
(ACCORDING TO IFRS)
The operating loss for first half
of 2018 was reduced by 34% to EUR 4,133k (H1 2017: EUR
6,262k). This was driven by lower research and development expenses
of EUR 2,572k (H1 2017: EUR 4,937k) following the completion
of the Phase 2a SAPHIR study in June 2017. In the first half of
2018 there was no clinical study. General and administrative
expenses increased by EUR 249k to EUR 1,578k (H1 2017:
EUR 1,329k). The first half year of 2017 was positively impacted by
finance income and the gain from income taxes of EUR 1,964 (H1
2018: EUR 0k) from the successful settlement of the potential tax
liability from the financial year 2004. Consequently, net loss was
reduced to EUR 4,120k (H1 2017: EUR 4,306k).
All results are in line with
management expectations.
Probiodrug held EUR 6,686k in cash
and cash equivalents as of June 30, 2018 (Dec 31, 2017:
EUR 10,291k).
The cash flow in the first half
year of 2018 was mainly driven by operating activities. EUR 475k
from investing activities resulted from proceeds from the
expiration of pension liabilities insurance.
OPERATIONAL REVIEW
Lead compound
PQ912 - a first-in-class highly specific and potent Glutaminyl
Cyclase (QC) inhibitor
Detailed design of Phase 2b core program
outlined
Probiodrug presented the detailed study design of the Phase 2b core
program for its QC inhibitor which incorporated the newest FDA and
EMA draft guidance for early AD trials.
The Phase 2b core program will
consist of two clinical trials in the EU and USA. The first Phase
2b study will investigate the safety and efficacy of the optimal
dose range of PQ912 in early AD patients. This trial will build on
the excellent and efficient infrastructure established by the Phase
2a SAPHIR study. It is based on the valuable results of the SAPHIR
study and has been designed with the guidance of international KOLs
in the AD field. Prof Philip Scheltens, M.D. Ph.D., Director of the
Alzheimer Center VU University Medical Center Amsterdam, NL, will
once again serve as Principal Investigator and Chairperson for the
study in the EU. A second complementary study is currently in the
planning phase and is intended to be carried out in the USA at the
Alzheimer Disease Cooperative Study Group (ADCS) at the University
of California, San Diego, USA, which will be chaired by Prof Howard
Feldman, also a highly renowned Principal Investigator.
Phase 2a data presented at leading Alzheimer's disease
conference
In March 2018, Probiodrug gave a presentation entitled "Inhibition of glutaminyl cyclase as a new concept for the
treatment of Alzheimer's disease: PQ912, the first-in-class
QC-inhibitor in clinical development for AD" at the
255th National
Meeting & Exposition of the American Chemical Society (ACS),
New Orleans, USA. Detailed information can be found here.
PBD-C06 - a
monoclonal antibody selectively targeting pGlu-Abeta
PBD-C06 is currently in preclinical stage. The antibody 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.
PBD-C06 revealed a unique binding
mode, published in the Journal of Biological Chemistry
(Piechotta et al., J. Biol. Chem. 2017
292:12713). The publication is available here.
In May 2018, Probiodrug announced
that results from its preclinical candidate antibody PBD-06 were
reviewed in Schilling et al., Molecules 2018,
23, 1068 (publication can be found here).
CORPORATE
REVIEW
Management
Changes
Probiodrug announced the appointment of Dr. Ulrich Dauer as Chief
Executive Officer effective from May 1, 2018. Dr. Dauer teamed
up with long-serving Chief Development Officer, Dr. Inge Lues, who
has led the development of Probiodrug's pipeline. Dr.
Konrad Glund and Dr. Hendrik Liebers left the management board of
the Company effective April 30, 2018.
Annual
Shareholders' Meeting 2018 / Supervisory Board
On June 21, 2018, Probiodrug held its 2018 Annual Shareholders'
Meeting. All items presented for resolution by the management board
and the supervisory board were approved with a large majority and
can be found here.
Dr. Erich Platzer, Charlotte
Lohmann, Dr. Dinnies von der Osten and Dr. Jörg Neermann were
re-elected as members of the Supervisory Board, with Dr. Platzer
appointed as Chairman and Dr. von der Osten appointed as
Vice Chairman and Chairman of the Audit Committee.
POST PERIOD HIGHLIGHTS
There were no significant events subsequent to the
reporting period.
OUTLOOK
The mid-term focus of Probiodrug's business activities can be
summarized as follows:
-
Execution of the Phase 2b clinical study program
for PQ912
-
Identifying industrial partners
-
Further strengthening Probiodrug's financial
resources
Probiodrug projects a net loss for the financial year of 2018
which, based on the current budget, is expected to be lower than
that of 2017.
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 on the company website. The conference will be
held in English. To participate in the conference call, please dial
the applicable country dial in number 10 minutes prior to
commencement.
Please dial one
of the following access numbers, then enter your PIN Code:
84802730#
A Question & Answer session will follow the presentation of
results.
| Country |
Toll-free |
Toll/Local |
|
Belgium |
|
+3211500307 |
| Germany |
08006270715 |
+4969222229043 (EN)
+4969222229044 (DE) |
|
Netherlands |
|
+31107137273 |
| Switzerland |
0800005200(EN)
0800005205(DE) |
+41225805970 (EN)
+41225805971 (DE) |
|
UK |
|
+442030092452 |
| USA |
|
18554027766 |
KEY FIGURES (ACCORDING TO
IFRS)
| |
|
|
|
| In EUR k,
unless otherwise stated |
Jan. - June 2018 |
Jan. - June 2017 |
Jan. - Dec. 2017 |
|
Earnings, Financial and Net Assets
Position |
|
|
|
|
Operating loss |
-4,133 |
-6,262 |
-9,961 |
|
Finance income (expenses) net |
13 |
856 |
856 |
|
Income tax gain |
0 |
1,102 |
1,102 |
| Net
loss for the period |
-4,120 |
-4,306 |
-8,009 |
|
Equity (end of the reporting period) |
4,848 |
12,211 |
8,923 |
|
Equity ratio (end of the reporting period) (in %) |
67.6% |
81.6% |
82.9 % |
|
Balance sheet total (end of the reporting period) |
7,169 |
14,971 |
10,762 |
| Cash
flows from operating activities (cum.) |
-4,092 |
-7,508 |
-12,117 |
Cash
flows from operating activities
(monthly average) |
-682 |
-1,251 |
-1,010 |
| Cash
flows from investing activities |
471 |
-4 |
459 |
| Cash
flows from financing activities |
0 |
0 |
127 |
|
Personnel |
|
|
|
| Total number of
employees (incl. Board of management) (end of the reporting
period) |
14 |
14 |
15 |
|
Probiodrug-Share |
|
|
|
| Loss per share
(basic/diluted) (in EUR) |
-0.51 |
-0.53 |
-0.98 |
Number of shares issued
(end of the reporting period) |
8,208 |
8,187 |
8,208 |
FINANCIAL STATEMENTS
January to
June 2018
Probiodrug has finalized its
financial statements for the first six months of 2018 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 2018
November 29,
2018
Interim Management Statement Q3 2018
###
For more
information, please contact:
Probiodrug
Dr Ulrich Dauer, CEO
Email: contact@probiodrug.de
Optimum Strategic
Communications
Mary Clark, Supriya Mathur, Hollie Vile
Tel: +44 (0) 203 714 1787
Email: probiodrug@optimumcomms.com
Solebury
Trout
Michael Levitan
Tel: +1 (646) 378-2920
Email: MLevitan@troutgroup.com
MC Services
AG
Anne Hennecke, Susanne Kutter
Tel: +49 (0) 211 529 252 27
Email: probiodrug@mc-services.eu
Notes to Editors:
About Probiodrug AG
Headquartered in Halle (Saale), Germany, Probiodrug AG (Euronext
Amsterdam: PBD) is a clinical stage biopharmaceutical company
focused on the development of new therapeutic products for the
treatment of Alzheimer's disease (AD). Probiodrug has identified a
new therapeutic concept linked to disease initiation and
progression. The development approaches are targeting a key
neuro-/synaptotoxic component of the pathology, pyroglutamate-Abeta
(pGlu-Abeta) as a therapeutic strategy. The enzyme Glutaminyl
Cyclase (QC) plays a central role in this process.
Its lead product, PQ912, has
successfully completed a Phase 2a (SAPHIR) study. The company's
pipeline also includes PBD-C06, an anti-pGlu-Abeta-specific
monoclonal antibody, in preclinical development. Probiodrug has
medical use and composition of matter patents related to the
inhibition of QC and anti-pGlu-Abeta-specific monoclonal
antibodies, and has, in the Company's view, a leading position in
this field of research.
About
PQ912
PQ912, is a first-in-class, highly specific and potent inhibitor of
Glutaminyl Cyclase (QC), the enzyme catalyzing the formation of
synaptotoxic pGlu-Abeta. PQ912 has shown therapeutic effects in AD
animal models. A Phase-1 study in healthy young and elderly
volunteers revealed a dose dependent exposure and showed good
safety and tolerability up to the highest dose resulting in >90%
target occupancy in the spinal fluid. In June 2017, Probiodrug
announced top-line data of the Phase 2a SAPHIR trial of PQ912 and
presented the study results at CTAD 2017. Results strongly support
(a) the hypothesis of pGlu-Abeta being synaptotoxic and (b) the
therapeutic concept pursued by Probiodrug. The study provides
important guidance how to move forward with the development of
PQ912 as a disease-modifying drug for AD. Altogether, the results
make the program highly attractive for further development; the
company has initiated the preparation of a Phase 2b core
program.
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. Today, 47
million people live with dementia worldwide, and this number is
projected to treble to more than 131 million by 2050, as the global
population ages. Dementia also has a huge economic impact.
Alzheimer's has an estimated, global societal cost of US$ 818
billion, and it will become a trillion-dollar disease by 2018.
(World Alzheimer Report 2016)
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.