Probiodrug AG
Reports Third Quarter 2018 Business Update
HALLE (SAALE),
Germany, 29 November 2018 - Probiodrug AG (Euronext
Amsterdam: PBD), a clinical stage biopharmaceutical company
developing novel therapeutic solutions to treat
Alzheimer's disease (AD), today announces its third quarter
business update for the period ending September 30, 2018.
The third quarter 2018 report is
available for download on the company website
(http://www.probiodrug.de/investors/reports-and-presentations/).
KEY HIGHLIGHTS
-
Probiodrug appoints Dr. Michael Schaeffer as
Executive Vice President of Business and Strategy, September 2018;
promoted to Chief Business Officer, effective October 1, 2018
(after period-end)
-
Expenditures and corresponding liquidity
position (September 30, 2018: EUR 5.3 million) in line with
management expectations
FINANCIAL REVIEW (ACCORDING TO IFRS)
The third quarter of 2018 was
characterized by EUR 939k research and development expenses,
slightly lower than in the third quarter of 2017 (EUR 1,127k).
General and administrative expenses amounted to EUR 689k and were
higher than in the third quarter of 2017 (EUR 526k). The Company
did not generated any revenue in the reporting period, in line with
corporate planning. Correspondingly, the net loss of the period was
EUR 1,634k, compared to EUR 1,656k in the third quarter of
2017.
All results are in line with
management expectations.
Probiodrug held EUR 5.3 million in
cash and cash equivalents as of September 30, 2018.
OPERATIONAL
REVIEW
Lead compound
PQ912 - a first-in-class highly specific and potent Glutaminyl
Cyclase (QC) inhibitor
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EMA draft guidance for early AD trials.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.
PBD-C06 - a
monoclonal antibody selectively targeting pGlu-Abeta
PBD-C06 is currently in the 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 in 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 for increased microhemorrhages after treatment with
PBD-C06.
CORPORATE
REVIEW
Management
Changes
Dr. Michael Schaeffer was appointed to the position of Executive
Vice President of Business and Strategy, effective August 2018. Dr.
Schaeffer brings more than 15 years of experience across pharma and
biotech in strategic business development, scientific project and
alliance management to Probiodrug.
POST PERIOD
HIGHLIGHTS
Management
Changes
Probiodrug announced the appointment of Dr. Michael Schaeffer to
Chief Business Officer, effective October 1, 2018. Drawing on his
extensive experience in neurology projects across all stages of
development, Dr. Schaeffer has additionally taken over Probiodrug's
R&D division. Dr. Inge Lues' term as Chief Development Officer
came to an end effective October 31, 2018, with the contractual
termination of her current agreement.
Extraordinary
General Meeting of Shareholders 2018
On December 7, 2018, Probiodrug will held an Extraordinary General
Meeting of Shareholders. The single item on the agenda: Report of a
loss amounting to half the share capital pursuant to Sec. 92 pa-ra.
1 AktG.
OUTLOOK
The mid-term focus of Probiodrug's
business activities remain unchanged and can be summarized as
follows:
-
Execution of the Phase 2b clinical study program
for PQ912
-
Identifying industrial partners
-
Further strengthening Probiodrug's financial
basis
The company's current financial
resources are expected to be sufficient to fund operations until
the end of Q3/2019.
###
For more
information, please contact:
Probiodrug
Dr. Ulrich Dauer, CEO
Email: contact@probiodrug.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.com
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, 50
million people live with dementia worldwide, and this number is
projected to treble to more than 152 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$ 1
trillion, and it will become 2 trillion dollar disease by 2030.
(World Alzheimer Report 2018).
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.