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
COMMENTS FROM THE CEO
Patients have been included in all regions in the global phase III program for PledOx®
The largest milestone in PledPharma’s history occurred during the last quarter of 2018, with the inclusion of the first patient in the PledOx® phase III program POLAR in November. We are now well on our way to a potential market registration of PledOx® and thus a step closer to providing preventive treatment against nerve damage for the hundreds of thousands of patients undergoing chemotherapy for their colorectal cancer. With no approved treatment against this condition, the execution of the trial is of highest priority for us. Following a successful safety and tolerability Phase I study in Japanese healthy volunteers, the Japanese Medicines Agency (PMDA) supported the expansion of PledOx® Phase III program to include Japanese patients. In January, our Asian partner Solasia Pharma announced the inclusion of the first patient in the Phase III study POLAR-A which triggered the first development milestone payment of c.SEK 49 million from our partner.
With patients included in all regions of the POLAR program (USA, Europe, Asia) it is very satisfying that we are able to maintain our long-term plan to deliver top line data in the fourth quarter of 2020.
Planning of next Aladote® study after positive proof of principle study outcome
We announced positive results from Aladote’s® phase Ib/IIa-proof of principle study, in July, its primary objective – to document the drug’s safety and tolerability – was achieved. In addition, secondary objectives was also met, as exploratory biomarkers indicate reduced liver injury in paracetamol-intoxicated patients treated with Aladote®.
Since Aladote® is a first in class drug, we applied for orphan drug designation to the FDA in December 2018. An approval may provide favourable conditions from a cost and time to market approval perspective.
A design proposal for the next study has been developed with our scientific advisory board, and will form the basis of our upcoming regulatory interactions.
Strengthened competence in the organization
We have strengthened our expertise in CMC and manufacturing by employing Anders Sveno as Head of CMC and Supply Chain in April. Furthermore we have also strengthened our competence in clinical development through the recruitment of Helene Depui Ekdal, with 25 years of experience in drug development. Ms Depui Ekdal started as the Clinical Development Director in January 2019.
Strong start to the new year and a planned listing on the main market
The new year has begun with a strong scientific interest for both PledOx® and Aladote® which have been and will be presented at several international scientific conferences.
Furthermore, another step in our ambition is to list our company shares on Nasdaq Stockholm’s main market. We see an uplisting as a natural step that reflects the maturity of our business from a capital markets perspective, which can contribute to increased interest from a broader investor base.
With the first patients included in the US, EU and Japan in the PledOx® Phase III program, our first development milestone payment from our partner, next development phase for Aladote®, the scientific interest in our products, the globally robust IP portfolio for PledOx® and Aladote® and a transformed and strengthened organization I am very excited for our continued work in 2019.
Nicklas Westerholm, CEO