Stockholm, 2015-02-17 08:30 CET (GLOBE NEWSWIRE) --
Significant events during the fourth quarter
- All patients included in the PLIANT study
- The third and last futility analysis in the PLIANT study approved by the DSMB
- The new project PP-100, with the drug candidate AladoteTM against acetaminophen induced poisoning, presented
- A rights issue for the financing of PP-100 raised approximately SEK 72m net.
Quarter and full year summary
- Net result for the quarter amounted to SEK -17 706 (-6 961)k and to -48 420 (-25 549)k for the full year
- Cash and cash equivalents on December 31 amounted to SEK 100 043 (49 302)k
- Cash flow from operating activities amounted to SEK -12 577 (-5 607)k for the quarter and to -41 385 (-28 066)k for the full year
- Result per share amounted to SEK -0.7 (-0.3) for the quarter and to -2.1 (-1.2) for the full year.
Other significant events during 2014
- Positive data from the first part of the PLIANT study
- PledPharma was awarded Nordic Star of the Year at the Nordic Life Science Days 2014.
CEO comment
2014 has been an eventful year for PledPharma not least as we reached several very important developmental milestones in the colorectal cancer study PLIANT. Among other things, we have received data from the first open part of the study, and included all patients in the randomized part of the study. We have also presented and financed a new and important project for the treatment of acetaminophen (paracetamol) induced poisoning, PP-100 with the drug candidate AladoteTM.
An important goal for the PLIANT study has been to show that PledOx® only protects healthy cells and not cancer cells, from the effect of chemotherapy. Three safety analyzes have therefore been performed by the independent expert panel DSMB. The analyses were made on the first 90 patients who underwent four treatments with chemotherapy, and were completed without remarks. This means that the given doses of PledOx did not attenuate the effect chemotherapy has on cancer cells, and that the study was allowed to proceed as planned.
During the summer we also got the results for the five patients from the first open part of the PLIANT study treated with the antibody bevacizumab in combination with FOLFOX. The results showed that the patients tolerated PledOx well.
In addition to our progress with the PLIANT study we have during the year worked on a new project based on the PLED platform which is assessed to have a significant commercial potential. The project PP-100, with the drug candidate Aladote, is focused on reducing or preventing the occurrence of serious liver damage as a result of overdosing of acetaminophen, one of the most common drug poisonings.
Although we are working with external advisors for licensing, we believe that it is also important at this stage to strengthen our internal business development skills and experience. We have therefore at the beginning of 2015 decided to bring in Anders Härfstrand, MD, PhD as responsible for Business Development. Anders, who has extensive experience in licensing, will together with an internal team and our external advisors conduct the company's work around an out-licensing of PledOx. We have also in the beginning of 2015 significantly strengthened our internal resources in senior technical patent skills by Professor James Van Alstine, who is inventor on more than 50 patents.
At the end of the year we secured the development of the project through a rights issue with the goal to take the project through a phase II study and a licensing deal.
Acetaminophen is the most widely used drug in the world in the treatment of pain. Acetaminophen poisoning is also one of the most common poisonings for intentional or unintentional overdosing. Acetaminophen is considered to be one of the gentlest of pain medications and it can be difficult to learn at the onset that acetaminophen has been accidentally overdosed because the difference between normal and toxic dose is small while the symptoms can be quite vague or missing altogether in the first days after overdosing. Acetaminophen poisoning can lead to, among other things, acute liver failure, which in turn may result in the need for liver transplantation and can at worst result in death.
The existing treatment for overdose of acetaminophen, N-acetylcysteine, is effective if the affected seeks medical care within eight hours after ingestion of acetaminophen. For patients with later arrival there is currently no well-functioning treatment despite the high risk of liver damage. The project goal is to extend this treatment window, and preclinical results clearly show that the drug candidate Aladote can normalize the elevation of certain liver enzymes that are indicators of liver failure long after N-acetylcysteine ceased working.
Entering 2015, we stand strengthened both financially and developmentally with a solid foundation in our PLED platform, and with the important development projects for PledOx and Aladote. In the near future, overall performance (top-line data) from PLIANT study is to be presented.
Jacques Näsström
CEO, PledPharma AB (publ)
PledPharma in brief
PledPharma is a Swedish pharmaceutical company that develops new therapies for the treatment of life threatening diseases. PledPharma has the potential to offer patients valuable and unique treatments for serious life-threatening diseases where there also is an opportunity for earlier registration in the US through "breakthrough therapy" designation.
In project PP-095, PledOx® is developed to reduce severe side-effects associated with chemotherapy. In project PP-100, the ability of Aladote™ in reducing or preventing acute liver failure due to acetaminophen (paracetamol) overdose is investigated. Project PP-099 is based on limiting reperfusion injuries in patients with acute myocardial infarction undergoing percutaneous coronary intervention.
PledPharma (STO:PLED) is since April 2011 listed on NASDAQ Stockholm First North. Erik Penser Bankaktiebolag is the Certified Adviser. For further information, please visit www.pledpharma.se
For further information contact:
Jacques Näsström, CEO cell +46 73 713 09 79
Johan Stuart, CFO cell +46 70 66 44 096
