Interim report January – September 2011
October 27, 2011
PledPharma AB
Interim information
Interim report January - September 2011
Stockholm, 2011-10-27 08:30 CEST (GLOBE NEWSWIRE) --
Activities ahead of clinical studies are progressing according to plan
The period July- September
-- Net profit amounted to SEK -2.485k (- 910k)
-- Earnings per share amounted to SEK -0.1 (SEK -3.0)
-- The loan of SEK 4.2 million has been repaid to Accelerator Nordic AB
-- Two 3-month safety studies of PledOx initiated prior to the start of the
phase IIb study in colorectal cancer patients, expected to start mid-2012.
-- Product (mangafodipir) for acute myocardial infarction clinical study
manufactured. Final assessments to be done before the product can be
approved by the medical products agency before restarting the prospective
clinical phase IIa study.
-- Marie Bengtson was hired as Clinical Project Director, and Erik Kinnman, as
medical expert and VP Investor Relations.
The period January-September
-- Net profit amounted to SEK -7.820k ( -2.191k)
-- Earnings per share amounted to SEK -0.4 (- 7.3)
-- Cash and cash equivalents at September 30 amounted to SEK 97.659k (2.289k)
-- The initial safety studies have been conducted with good results
Comments from CEO
Jacques Näsström says: We anticipate that our phase IIa clinical trial in acute
myocardial infarction will be resumed around the year end. The manufacturing
process of a product of this study has gone well and is in the final phase. The
project with PledOx in colon cancer is in an intensive preparation phase before
the start of a Phase IIb study in mid-2012. The initial safety studies have
been conducted with good results and the long-term safety studies started in
the third quarter. The design of the Phase IIb study is in the final stage and
the clinical protocol is underway and will be finalized in dialogue with the
authorities in the U.S. and Europe.
PledPharma is a Swedish specialty pharma company, which develops new treatments
of life threatening diseases
PledPharma currently runs two projects in clinical development phase II with
the patented drug substance class, PLED-derivatives. The preventive effect of
PLED-derivatives on adverse effects of chemotherapy in colon cancer is examined
in one trial. Another trial investigates the ability of PLED-derivatives to
reduce reperfusion injuries in myocardial infarction patients undergoing
percutaneous coronary intervention (PCI).
PLED-derivatives protect the body's normal cells against oxidative stress,
which is a condition due to overproduction of free oxygen radicals.
PLED-derivatives have in previous pre-clinical trials been shown to protect
against oxidative stress. Moreover, the PLED-derivative mangafodipir protected
against the side effects of chemotherapy in colorectal cancer.
PledPharma (STO:PLED) is listed on NASDAQ OMX First North.
For further information contact:
Erik Kinnman, VP Investor Relations, cell + 46 73 422 15 40
Michaela Johansson, CFO, cell +46 709 26 17 75
Jacques Näsström, CEO cell +46 73 713 09 79
