Interim Report Second Quarter 2013
August 29, 2013
PledPharma AB
Interim information
Interim Report Second Quarter 2013
Stockholm, 2013-08-29 08:30 CEST (GLOBE NEWSWIRE) --
Significant events after the end of the period
· Four out of the six patients who are needed to start the second part of
the Phase IIb
study PLIANT have been treated and the results are in line with our
expectations
· Patent for the use of PLED compounds in the treatment of cancer approved
in China
Significant events during April - June
· Rights issue provided the company with 18.6 million SEK.
· IMS Consulting Group appointed advisor for the commercialization of
PledOx®
· Sten Nilsson, MD, PhD Professor of Oncology at Karolinska University
Hospital and
Institutet in Stockholm elected as member of the board.
· All patients included in the small clinical phase IIa study MANAMI,
examining a PLED
-compound’s ability to limit reperfusion injuries in patients with acute
myocardial infarction
treated with percutaneous coronary intervention (PCI).
· PledOx® registered trademark in the US, Switzerland and Australia
· Net result amounted to SEK -6 048k (-10 548k)
· Cash and cash equivalents on June 30 amounted to SEK 59 116k (68 608k)
· Cash flow from operating activities amounted to SEK -7 708k (-13 038k)
· Result per share amounted to SEK -0.3 (-0.5)
Significant events during January – June
· Patent application for the use of PLED compounds in the treatment of
cancer approved
and issued in the US and Russia
· FDA approved IND application for the clinical trial PLIANT in the US
· The first patients treated in the PLIANT study
· Net result amounted to SEK -14 079k (-19 825k)
· Cash flow from operating activities amounted to SEK -18 252k (-21 889k)
· Result per share amounted to SEK -0.6 (-1.0)
CEO comments
" The rights issue in PledPharma completed in May was oversubscribed. The
purpose of the rights issue was to expand the PLIANT study with more study
centres worldwide to secure implementation, and to achieve greater flexibility
to close the best possible licensing deal for PledPharma’s drug candidate
PledOx®.
Four out of six patients in the dose escalation phase are now treated with
PledOx. In total, the patients have been treated with more than 20 doses of
PledOx in conjunction with chemotherapy and all patients have tolerated PledOx
well. With reservation to the small number of patients treated, the results are
in line with our expectations, which we consider to be positive.
When all six patients are treated with PledOx we look forward to an approval
from DSBM (Drug Safety Monitoring Board) to begin the inclusion of patients for
the subsequent randomized part of the study. In the US, where PledOx is
evaluated with FOLFOX in combination with the antibody Avastin, the three
remaining patients for the US part of the study will be recruited in parallel
with the last patients for the rest of the world. We expect to start the second
part of the study during 2013 and the recruitment of the 126 patients included
in the study can be done in parallel at the approximately 30 centres. Our
ambition remains that we can attain "top line" results from the study in
mid-2014.
Parallel to the PLIANT study we have made progress in preclinical development
on a new life-threatening indication for PLED-derivatives where we believe that
there are both medical need and a large commercial potential, "said CEO Jacques
Näsström.
For further information contact:
Jacques Näsström, CEO cell +46 73 713 09 79
[email protected]
Michaela Johansson, CFO cell +46 70 926 17 75
[email protected]
About PledPharma
PledPharma is a Swedish specialty pharma company that develops PledOx® in order
to prevent serious side effects during chemotherapy treatment of cancer. These
side effects are often so severe that the treatment cannot be completed as
planned. The global market for supportive cancer care is about SEK 70 billion.
PledOx is a drug candidate in the patented substance class PLED, which protects
the body's normal cells against oxidative stress. PledOx is a lowMEM (Low
Molecular Enzyme Mimetic) that mimics the body's own enzyme manganese
superoxide dismutase (MnSOD), which is our main protection against oxidative
stress. Oxidative stress is caused by overproduction of harmful oxygen/nitrogen
molecules, e.g. as a result of chemotherapy treatment. PledPharma is also
evaluating the possibility of using PLED substances during the treatment of
other life-threatening diseases.
