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 firstname.lastname@example.org Michaela Johansson, CFO cell +46 70 926 17 75 email@example.com 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.