Interim Report First Quarter 2013
April 18, 2013
PledPharma AB Interim information Interim Report First Quarter 2013 First patient treated in the PledOx™ phase IIb study, PLIANT Stockholm, 2013-04-18 14:00 CEST (GLOBE NEWSWIRE) -- Significant events after the end of the period • PledPharma proposes a rights issue of shares that can provide the company with up to 18.6 million SEK. The proposal will be tabled at an EGM to be held in conjunction with the AGM on April 18. The share issue is done to expand the PLIANT study with more study centers worldwide to ensure the recruitment rate and to achieve greater flexibility and time to perform the best possible out-licensing deal of PledPharma's drug candidate PledOx • All patients included in the ongoing small clinical phase IIa study MANAMI, examining another PLED-compound’s ability to limit reperfusion injuries in patients with acute myocardial infarction treated with percutaneous coronary intervention (PCI) Significant events during January – March • First patient treated at Uppsala University Hopsital (UAS) in the PledOx™ phase IIb study PLIANT • Green light received from the DSMB (Drug Safety Monitoring Board), an independent panel of experts) to continue patient recruitment for the phase IIb study PLIANT • FDA approved the IND application for the clinical trial PLIANT in the US • Addition of the Oncology clinics at Linköping University Hospital and the University of Texas Health Science Center, San Antonio, USA, to the first part of the PLIANT study • The Swedish Medicinal Products Agency (MPA) approved expanding the patient base in the PLIANT study • Patent application regarding the use of PLED compounds in cancer treatment approved and issued in the US • Net result amounted to SEK -8 032k (-9 277k) • Cash and cash equivalents on March 31 amounted to SEK 48 264k (81 646k) • Cash flow from operating activities amounted to SEK -10 544k (-8 852k) • Result per share amounted to SEK -0.4 (-0.5) CEO comments "The first patient is now treated at Uppsala University Hospital (UAS) and we expect to be able to include the remaining 8-11 patients in the initial dose-escalation part of the study until mid-2013. Thereafter patients will be included at all clinics in the subsequent randomized part of the study. We have also decided to perform a rights issue of shares as a consequence of the delay in the recruitment of patients in the first part of the PLIANT study. We have taken measures to widen the patient base, additional centers in the first part of the study have been added, and the communication with patients as well as investigators has been improved. In addition we are offering resources to facilitate additional test in addition to standard of care to improve patient acceptance. The additional financial resources will be used to expand the PLIANT study with more study centers worldwide to ensure the recruitment rate in the randomized part of the study. With these measures, we believe that we can get "top line" results from the study by mid-2014. The share issue is done to achieve greater flexibility and time to implement the best possible out-licensing deal for PledPharma’s PledOx™, says Jacques Näsström, CEO of PledPharma. For further information please contact: Jacques Näsström, CEO +46 737 130979 [email protected] About PledPharma PledPharma is a Swedish specialty pharma company that develops PledOx™ for prevention of severe chemotherapy-induced side effects in cancer patients. Due to these side effects optimal treatment cannot be carried out. The current market for supportive cancer care is some SEK 72 billion. PledOx protects normal cells against oxidative stress. It belongs to a group of compounds named lowMEM (low Molecular Enzyme Mimetics), and mimics the enzyme Manganese SuperOxide Distmutase (MnSOD) – the most important endogenous cellular protectant against devastating oxidative stress. Oxidative stress is a condition caused by harmful oxygen/nitrogen molecules, e.g., as a result of chemotherapy treatment. The company is also evaluating opportunities of using PLED substances in other diseases. PledPharma (STO:PLED) is listed on NASDAQ OMX First North. Erik Penser Bankaktiebolag is the Certified Adviser. For further information, please visit www.pledpharma.se
