Year-end Report January-December 2018

February 21, 2019

SUMMARY

Financials for the quarter, October-December

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

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.

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)

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

For further information, please contact:

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

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