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Egetis is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment

Year-end Report January-December 2018

February 21, 2019


Financials for the quarter, October-December

  • Quarterly net sales MSEK 11.1 (13.6)
  • Quarterly result MSEK -22.1 (-32.1)
  • Cash flow from operating activities MSEK -21.0 (-45.4)
  • Result per share SEK -0.5 (-0.7)

October-December in brief

  • The first patient in the global Phase III program, POLAR, for PledOx® was included in the US
  • PledPharma prepares for listing on the Nasdaq Stockholm main market during 2019
  • Aladote® Phase Ib/IIa study results has been accepted for a poster presentation during the “58th Annual Meeting of the Society of Toxicology” in March, 2019
  • Pledpharma has submitted an Orphan Drug Designation (ODD) application to the US Food and Drug Administration (FDA) for the drug candidate Aladote®
  • The Nomination Committee for the 2019 AGM was appointed and includes members from the four largest shareholders who wished to participate
  • The Japanese and Asian investigator meetings for the POLAR studies were held in Tokyo and Seoul

Significant events after the reporting period

  • A milestone payment of 600 MJPY (c.49 MSEK) was triggered due to the inclusion of the first patient in Japan to the global Phase III program for PledOx®
  • Patients have been included in the POLAR-program in Europe
  • The PledOx® phase III program design was presented at the Gastrointestinal (GI) Cancers Symposium, in San Francisco.
  • Results from Aladote®’s study has been selected for oral presentation at The International Liver Congress, April 2019
  • PledPharma invites investors, financial analysts and media to a Capital Markets Day on March 26, 2019.

Financials for the period, January-December

  • Net sales for the period MSEK 28.2 (13.9)
  • Loss for the period MSEK -85.0 (-87.9)
  • Cash position MSEK 229.2 (309.5)
  • Cash flow from operating activities MSEK -81.0 (-86.6)
  • Result per share SEK -1.7 (-1.8)

January-December in brief


  • A delayed delivery of the study drug for the PledOx® phase III program was announced in February, which was remediated and subsequently delivered in September
  • PledOx® shows favorable safety and tolerability profile in the SUNCIST Phase I study in Japanese and Caucasian healthy volunteers
  • The European Medicines Agency (EMA) approved PledPharma’s waiver application for the paediatric investigation plan (PIP) regarding PledOx®
  • PledOx® and Aladote® receives an European approval of the composition of matter patent
  • The Japanese Medical Agency (PMDA) supports the expansion of the Phase III program for PledOx® to include Japanese patients


  • Aladote’s® proof of principle study has been completed with positive results announced in September
  • Multiple scientific presentations of Aladote’s® clinical results have been submitted and accepted
  • The Scientific Advisory Board for Aladote® was appointed and held its first meeting with focus on the design of the next study

PDF – Year-end Report January-December 2018


For further information, please contact:

Nicklas Westerholm, CEO
Tel. +46-(0)73 354 20 62

Yilmaz Mahshid, CFO
Tel. +46-(0)72 231 68 00




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Address: Klara Norra Kyrkogata 26, SE 111 22 Stockholm, Sweden

Phone: +46 8 679 72 10