Interim report January – June 2017
August 30, 2017
PledPharma AB
Interim information
Interim report January - June 2017
Stockholm, 2017-08-30 08:00 CEST (GLOBE NEWSWIRE) --
Q2 IN BRIEF
-- Nicklas Westerholm was recruited as the new CEO for PledPharma
-- PledPharma received advice from the FDA for the continued development of
PledOx® and is now following up with the EMA
-- Christian Sonesson was recruited as Vice President Product Strategy and
Development
-- Marie Ekström Trägårdh was elected to the board of directors
FINANCIALS
-- Quarterly result MSEK -16,2 (-12,0)
-- Cash MSEK 363,7 (31,7)
-- Cash flow from operating activities MSEK -19,6 (-12,0)
-- Result per share SEK -0,3 (-0,4)
-- A warrants program was established
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
-- PledPharma established a scientific advisory board for the PledOx® program
-- PledPharma recruited Stefan Carlsson as new Chief Medical Officer
-- 8 out of 24 patients completed their treatment in the Proof of principle
study with Aladote®
FIRST HALF YEAR IN BRIEF
-- Gunilla Osswald and Elisabeth Svanberg were elected to the Board of
Directors.
-- PledPharma's key patent application for the active pharmaceutical
ingredient of the drug candidates PledOx® and Aladote® was approved in
Japan and Russia.
-- Patent for the anticancer-effect of PLED compounds was approved in Canada
and an important use patent for PLED compounds was approved in Israel.
FINANCIALS - HALF YEAR
-- Result for the period MSEK -28,5 (-18,8)
-- Cash MSEK 363,7 (31,7)
-- Cash flow from operating activities MSEK -31,6 (-18,7)
-- Result per share SEK-0,6 (-0,7)
COMMENTS FROM THE CEO
It is with great pleasure and enthusiasm I have assumed the role as CEO of
PledPharma after about 20 years within the Astra and AstraZeneca Group, where I
developed my knowledge and gained experience in global drug development,
production issues, development cooperation and investor relations of global
drug development, production issues, development cooperation and investor
relations. Of course, there is much that is different between AstraZeneca and
PledPharma, but there are also challenges common to both companies. Not least,
the pursuit of professionally and efficiently developing new drugs that meet
unmet medical needs which creates significant value for the company's
Investors. Likewise, the need to ensure a well-functioning organization with
the skills and resources required to achieve set goals.
Since joining in June, my colleagues and I have focused our work in three areas:
Strengthen the organization and capabilities
We have started an intensive work to strengthen PledPharmas organization and
capabilities for the continued clinical development of our two pharmaceutical
projects PledOx® and Aladote®. This has already resulted in the recruitment of
two new key individuals. Dr Stefan Carlsson, in his role as Chief Medical
Officer, he will have overall responsibility for the continued clinical
development of our two drug candidates. Our new Vice President Product Strategy
& Development, Dr. Christian Sonesson, who will lead the remaining PledOx®
development program and be responsible for the design of pricing strategies,
initial market positioning and potential future indications. Both Stefan and
Christian have solid experience and knowledge within their areas of
responsibility.
Optimize the development programs
Optimized program for PledOx®
The most central task is to optimize the design of the remaining clinical
development program for PledOx® in terms of cost aspects, time efficiency and
quality. An important complement in this process is our newly established
scientific advisory board, consisting of five internationally leading experts
in oncology, neurology, chronic pain management and methods for measuring
patients' reported outcomes in clinical trials.
After receiving advice from FDA for forthcoming clinical studies with PledOx®
we are now following up with the European Medicines Agency (EMA).
Progress in the Aladote program
At the end of the quarter, we started our proof of principle study with
Aladote® and we are pleased to announce that one third of the patients have
already undergone treatment. This is the first time that Aladote® is tested in
patients who overdose paracetamol.
Increased transparency to the financial market
The third of my initial focus areas is to ensure high transparency and good
dialogue with the financial market. I have already had the opportunity to meet
several of our major shareholders and look forward to expanding my interactions
with both current shareholders and potential new investors in the autumn to
describe how we work to build commercial values in the company.
It is a combination of professional scientific work, clinical development work,
thought-through regulatory strategies, and - not least - business acumen that
provides the cornerstones for value growth in a company of PledPharma's
character. I will do my utmost to ensure that the company optimizes its work in
all of these areas.
Nicklas Westerholm
CEO
For further information, contact:
Nicklas Westerholm, CEO
Phone: +46 73-354 20 62
E-mail: [email protected]
Michaela Gertz, CFO
Phone: +46 70-926 17 75
E-mail: [email protected]
This information is such information as PledPharma AB (publ) is obliged to
disclose in accordance with EU market abuse regulation and the Securities
Markets Act. The information was submitted, through the above contact persons,
for publication on 30 August 2017 at 8.00 am (CET)
About PledPharma
PledPharma develops new drugs that protect the body against oxidative stress –
a potentially debilitating and sometimes life-threatening condition that can be
caused by chemotherapy treatment and following acetaminophen (paracetamol)
overdose. The company's most advanced project PledOx® is being developed to
reduce nerve damage associated with chemotherapy. A phase IIb study has been
conducted and will serve as the basis for the continued development. The drug
candidate Aladote® is being developed to reduce the risk of acute liver failure
associated with acetaminophen poisoning. PledPharma (STO: PLED) is listed on
Nasdaq First North. Erik Penser Bank is the company’s Certified Adviser (phone
+46 8 463 80 00). For more information, see www.pledpharma.se
