PledPharma AB (publ) Interim report January-September 2012
October 26, 2012
PledPharma AB Company Announcement PledPharma AB (publ) Interim report January-September 2012 Patient screening ongoing ahead of inclusion in the PledOx™ Phase IIb study Stockholm, 2012-10-26 08:30 CEST (GLOBE NEWSWIRE) -- The period July – September · The design of the clinical study for PledOx has been approved by the Swedish Medical Products Agency (MPA) · Selection of patients ongoing at Uppsala University Hospital and Karolinska University Hospital in Solna and for inclusion in the PledOx Phase IIb study in colorectal cancer · Participating clinics in the PledOx study have been chosen. Around 30 high-quality clinics in eight countries, including Sweden and the US, will participate in the study · Net result amounted to SEK -5 642k (-2 485k) · Cash and cash equivalents on Sept 30 was SEK 65 487k (97 659k) · Cash flow from operating activities amounted to SEK -3 121k (-5 659k) · Result per share amounted to SEK -0.28 (-0.12) The period January – September in summary · Net result amounted to SEK -25 467k (-7 820k) · Cash flow from operating activities amounted to SEK -25 010k (-7 284k) · Result per share amounted to SEK -1.26 (-0.39) · Professor Bengt Glimelius at Uppsala University Hospital, a world authority within research and treatment of cancer, coordinating principal investigator of the PledOx study · Positive results 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 · 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 adverse events due to chemotherapy in patients pretreated with PLED-substance, in a scientific journal CEO comments “Patient screening is ongoing in the open dose-escalation phase of the study at Karolinska University Hospital in Solna and Uppsala University Hospital. We expect to include the first patient in the coming month. Nine to twelve patients will be included in this part of the PledOx study until the beginning of 2013. The other clinics will start thereafter”, says CEO Jacques Näsström. For further information please 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
