PledPharma AB (publ) Interim report January – June 2012
August 24, 2012
PledPharma AB Interim information PledPharma AB (publ) Interim report January – June 2012 PledOx™ clinical study design approved Stockholm, 2012-08-24 08:30 CEST (GLOBE NEWSWIRE) -- The period April – June · Net result amounted to SEK -10 548k (-2 488k) · Cash flow from operating activities amounted to SEK -13 038k ( 1 837k) · Result per share amounted to SEK -0.52 (-0.19) Significant events after the end of the period · The design of the clinical study for PledOx was approved by the Swedish Medical Products Agency (MPA) August 1 · Professor Bengt Glimelius at Uppsala University Hospital, a world authority within research and treatment of cancer, especially cancer in the gastrointestinal canal, coordinating principal investigator of the PledOx study · Positive results achieved in the long term preclinical PledOx safety studies · A new composition of matter patent application for PledOx provides additional strong and extended patent protection opportunities The first half Year in summary · Net result amounted to SEK -19 825k (-5 336k) · Cash flow from operating activities amounted to SEK -21 889k (-1 625k) · Cash and cash equivalents on June 30 was SEK 68 608k (106 165k) · Result per share amounted to SEK -0.98 (-0.40) · Positive and supportive meetings with the MPA and the US regulatory authority (FDA) regarding the PledOx study · Publication of clinical study, showing a decreased number of serious incidences due to chemotherapy in patients pretreated with PLED-substance, in a scientific journal CEO comments “We are very pleased to have delivered all necessary interim goals necessary to initiate our important clinical PledOx Phase IIb trial in colorectal cancer patients. The study design is now approved by the Swedish MPA and we expect to recruit the first patient in September/October 2012. This is a very important milestone in the development of the company”, says CEO Jacques Näsström. For further information contact: Erik Kinnman, VP Investor Relations, cell + 46 73 422 15 40 Johan Stuart, CFO, cell +46 70 66 44 096 Jacques Näsström, CEO cell +46 73 713 09 79 About PledPharma PledPharma is a Swedish specialty pharma company that develops a new medicine, PledOx™, for prevention of the severe side effects that patients develop as a consequence of chemotherapy treatment of cancer. Many times the treatment cannot be carried out as planned due to very difficult side effects. The current market for supportive cancer care is some SEK 72 billion. PledOx is a medicine within the patent protected substance class PLED, which protects the body’s normal cells against oxidative stress. Oxidative stress is a condition where an overabundance of harmful oxygen molecules (free oxygen radicals) has been formed. We are also evaluating opportunities with PLED substances for other diseases. PledPharma (STO:PLED) is listed on NASDAQ OMX First North. Erik Penser Bankaktiebolag is the Certified Adviser. For more information, please visit www.pledpharma.se