Interim report January – March 2017


Stockholm, 2017-04-25 08:00 CEST (GLOBE NEWSWIRE) --

January – March summary

  • Net result for the period amounted to KSEK -12 281 (-6 846)
  • Cash equivalents at the end of the period amounted to KSEK 382 041 (43 684)
  • Cash flow from operating activities amounted to KSEK -11 958 (-6 676)
  • Result per share amounted to SEK -0.3 (-0.2)

Significant events during the period

  • Gunilla Osswald and Elisabeth Svanberg were elected to the Board of Directors. Håkan Åström and Sten Nilsson will remain on the board.
  • PledPharma's key patent application for the active pharmaceutical ingredient of the drug candidates PledOx® and Aladote® was approved in Japan and Russia.
  • Patent for the anticancer-effect of PLED compounds was approved in Canada and an important use patent for PLED compounds was approved in Israel.

Significant events after the end of the period

  • Nicklas Westerholm was appointed as new CEO of PledPharma.
  • At the AGM on April 25, 2017, Marie Ekström Trägårdh is proposed as a new member of the Board of Directors.


Activities during the quarter

The continued clinical development program for PledOx® is under evaluation and planning. Contacts with regulatory authorities, specialists within oncology and chemotherapy induced peripheral neuropathy, patient organizations, service providers (CROs) of clinical trials as well as commercial considerations will form the basis in the design of the continued development program for PledOx®. Manufacturing costs for the continued clinical studies, as well as costs for safety studies affected the quarterly results. In the Aladote® project, the start of a proof of principle study is being prepared and Dr James Dear - active in Edinburgh and key opinion leader in the field of acetaminophen poisoning - has been selected as the principal investigator. The first phase of this study will include 24 patients treated for acetaminophen poisoning.

During the first quarter of the year, patent protection for PledPharma's two drug candidates were strengthened when the company's patent application for the active pharmaceutical ingredient in PledOx® and Aladote® was approved in two additional countries with significant market potential - Japan and Russia.

During the quarter, Dr Gunilla Osswald and Dr Elisabeth Svanberg, both with extensive experience in clinical drug development, were selected as new members of the Board. Marie Ekström Trägårdh is proposed as a new member of the Board at the Annual General Meeting on April 25.

Nicklas Westerholm has since 1995 been working in the AstraZeneca Group in several global roles and different business areas, most recently as Vice President Project & Portfolio Management, Cardiovascular and Metabolic Diseases, Global Medicines Development Unit. Prior positions include roles as Executive Officer and Vice President of Japan Operations, Director Investor Relations, Head of Global API Supply and Head of Development Manufacture. Nicklas Westerholm has studied analytical and organic chemistry at Stockholm University, and Chemical Engineering at KTH Royal Institute of Technology. He has also participated in educational programs at the University of Warwick, INSEAD and Harvard Business School. 

I look forward to continuing the work with our unique data from the PLIANT study within PledPharma’s research and development and together with Nicklas Westerholm develop PledOx® to a valuable drug to reduce cancer patient’s suffering, says CEO Jacques Näsström.

Further recruitments are underway to ensure adequate resources and expertise relevant for the continued clinical development and commercialization of drug candidates PledOx® and Aladote®.

 

For more information, please contact:

Jacques Näsström, CEO, phone: +46 737 130 979

Michaela Gertz, CFO, phone: +46 709 26 17 75

 

About PledPharma

PledPharma develops new drugs that protect the body against oxidative stress – a potentially debilitating and sometimes life-threatening condition that can be caused by chemotherapy treatment and following acetaminophen (paracetamol) overdose. The company's most advanced project PledOx® is being developed to reduce nerve damage associated with chemotherapy. A phase IIb study has been conducted and will serve as the basis for the continued development. The drug candidate Aladote® is being developed to reduce the risk of acute liver failure associated with acetaminophen poisoning.

PledPharma (STO: PLED) is listed on Nasdaq First North. Erik Penser Bank is the company’s Certified Adviser (tel +46 8 463 80 00). For more information, see www.pledpharma.se

 

This information is information that PledPharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CET on April 25, 2017.


Pièces jointes

PledPharma Q1 Report ENG 170425.pdf