Year-end report 2014
February 17, 2015
PledPharma AB
Interim information
Year-end report 2014
Successful recruitment in the PLIANT-study and strengthened financial position
Stockholm, 2015-02-17 08:30 CET (GLOBE NEWSWIRE) --
Significant events during the fourth quarter
-- All patients included in the PLIANT study
-- The third and last futility analysis in the PLIANT study approved by the
DSMB
-- The new project
PP-100, with the drug candidate
Aladote(TM)
against
acetaminophen
induced poisoning, presented
-- A rights issue for the financing of PP-100 raised
approximately
SEK 72m net.
Quarter and full year summary
-- Net result for the quarter amounted to SEK
-17 706 (-6 961)k and to -48 420 (-25 549)k for the full year
-- Cash and cash equivalents on December 31 amounted to SEK
100 043 (49 302)k
-- Cash flow from operating activities amounted to SEK -12 577 (-5 607)k for
the quarter and to -41 385 (-28 066)k for the full year
-- Result per share amounted to SEK
-0.7 (-0.3)
for the quarter
and to -2.1 (-1.2) for the full year.
Other significant events during 2014
-- Positive data from the first part of the PLIANT study
-- PledPharma was awarded
Nordic Star of the Year at the Nordic Life Science Days 2014.
CEO comment
2014 has been an eventful year for PledPharma not least as we reached several
very important developmental milestones in the colorectal cancer study PLIANT.
Among other things, we have received data from the first open part of the
study, and included all patients in the randomized part of the study. We have
also presented and financed a new and important project for the treatment of
acetaminophen (paracetamol) induced poisoning, PP-100 with the drug candidate
Aladote(TM).
An important goal for the PLIANT study has been to show that PledOx® only
protects healthy cells and not cancer cells, from the effect of chemotherapy.
Three safety analyzes have therefore been performed by the independent expert
panel DSMB. The analyses were made on the first 90 patients who underwent four
treatments with chemotherapy, and were completed without remarks. This means
that the given doses of PledOx did not attenuate the effect chemotherapy has on
cancer cells, and that the study was allowed to proceed as planned.
During the summer we also got the results for the five patients from the first
open part of the PLIANT study treated with the antibody bevacizumab in
combination with FOLFOX. The results showed that the patients tolerated PledOx
well.
In addition to our progress with the PLIANT study we have during the year
worked on a new project based on the PLED platform which is assessed to have a
significant commercial potential. The project PP-100, with the drug candidate
Aladote, is focused on reducing or preventing the occurrence of serious liver
damage as a result of overdosing of acetaminophen, one of the most common drug
poisonings.
Although we are working with external advisors for licensing, we believe that
it is also important at this stage to strengthen our internal business
development skills and experience. We have therefore at the beginning of 2015
decided to bring in Anders Härfstrand, MD, PhD as responsible for Business
Development. Anders, who has extensive experience in licensing, will together
with an internal team and our external advisors conduct the company's work
around an out-licensing of PledOx. We have also in the beginning of 2015
significantly strengthened our internal resources in senior technical patent
skills by Professor James Van Alstine, who is inventor on more than 50 patents.
At the end of the year we secured the development of the project through a
rights issue with the goal to take the project through a phase II study and a
licensing deal.
Acetaminophen is the most widely used drug in the world in the treatment of
pain. Acetaminophen poisoning is also one of the most common poisonings for
intentional or unintentional overdosing. Acetaminophen is considered to be one
of the gentlest of pain medications and it can be difficult to learn at the
onset that acetaminophen has been accidentally overdosed because the difference
between normal and toxic dose is small while the symptoms can be quite vague or
missing altogether in the first days after overdosing. Acetaminophen poisoning
can lead to, among other things, acute liver failure, which in turn may result
in the need for liver transplantation and can at worst result in death.
The existing treatment for overdose of acetaminophen, N-acetylcysteine, is
effective if the affected seeks medical care within eight hours after ingestion
of acetaminophen. For patients with later arrival there is currently no
well-functioning treatment despite the high risk of liver damage. The project
goal is to extend this treatment window, and preclinical results clearly show
that the drug candidate Aladote can normalize the elevation of certain liver
enzymes that are indicators of liver failure long after N-acetylcysteine ceased
working.
Entering 2015, we stand strengthened both financially and developmentally with
a solid foundation in our PLED platform, and with the important development
projects for PledOx and Aladote. In the near future, overall performance
(top-line data) from PLIANT study is to be presented.
Jacques Näsström
CEO, PledPharma AB (publ)
PledPharma in brief
PledPharma is a Swedish pharmaceutical company that develops new therapies for
the treatment of life threatening diseases. PledPharma has the potential to
offer patients valuable and unique treatments for serious life-threatening
diseases where there also is an opportunity for earlier registration in the US
through "breakthrough therapy" designation.
In project PP-095, PledOx® is developed to reduce severe side-effects
associated with chemotherapy. In project PP-100, the ability of Aladote™ in
reducing or preventing acute liver failure due to acetaminophen (paracetamol)
overdose is investigated. Project PP-099 is based on limiting reperfusion
injuries in patients with acute myocardial infarction undergoing percutaneous
coronary intervention.
PledPharma (STO:PLED) is since April 2011 listed on NASDAQ Stockholm First
North. Erik Penser Bankaktiebolag is the Certified Adviser. For further
information, please visit www.pledpharma.se
For further information contact:
Jacques Näsström, CEO cell +46 73 713 09 79
Johan Stuart, CFO cell +46 70 66 44 096
