Interim report January-March 2019

January-March

• Quarterly net sales MSEK 54.9 (0.7)
• Quarterly result MSEK till 22,9 (-15,8)
• Cash and cash equivalents MSEK 258,0 (294,3)
• Cash flow from operating activities MSEK 28,0 (-15,2)
• Result per share SEK 0,5 (-0,3)
• PledPharma organized a Capital Markets Day

PledOx®

• PledPharma received MJPY 600, ca. MSEK 49, in milestone payment due to the inclusion of the first Asian patient into the global Phase III program for PledOx®
• Patients were included in Europe in the global Phase III program for PledOx® during the quarter
• PledPharma initiated an indication expansion program for PledOx in CIPN associated with taxanes
• PledPharma presented PledOx®’s global Phase III program at the Gastrointestinal (GI) Cancers Symposium, ASCO-GI

Aladote®

• Aladote® has been granted Orphan Drug Designation by FDA
• Results from the POP study support further development of Aladote® as a new treatment option for reducing the risk of acute liver injury associated with acetaminophen poisoning
• The POP study was presented at the global ”58th Annual Meeting of the Society of Toxicology” in the USA

Significant events after the reporting period

• PledPharma’s drug candidate Aladote® and its POP study results were recognized as one of the highlights at one of the world’s largest liver conferences, European Association of the Study of the Liver International Liver Congress (EASL ILC)

Comments from the CEO

Aladote® granted Orphan Drug Designation and PledOx® global Phase III program is progressing on 3 continents

Aladote granted Orphan Drug Designation
We are very pleased and proud that Aladote® was granted orphan drug designation (ODD) status by the FDA in March. It facilitates and enables the acceleration of Aladote® ‘s development to meet the significant medical needs of paracetamol poisoning. The ODD status will potentially result in shorter development time and for us also lead to lower development costs. In addition, we will receive further dedicated support from the FDA during the drug development process and seven years of market exclusivity.
Proposals for the design of the next study have been finalised together with our external advisory board and will serve as the basis for upcoming regulatory interactions.

The Phase III program for PledOx® is ongoing on all three continents
Another important step was taken in the global Phase III program, POLAR, to document PledOx® efficacy and thus become the first approved drug to prevent nerve damage (CIPN) caused by chemotherapy. In January, our Asian partner Solasia Pharma announced that the first patient had been included in Japan. As a result we received our first milestone payment of MSEK 49 from Solasia.
Patients have also been included in Europe during the quarter. With patients included in all of the POLAR program’s regions (US, Europe, Asia) we are working diligently and focused to deliver top line results in the fourth quarter of 2020.

Indication expansion for PledOx®
To create further value with PledOx® an indication expansion program in CIPN associated with taxanes was initiated in the first quarter. This chemotherapeutic agent which have significant use in clinical practice do also cause CIPN. Our ambition is to create an additional opportunity to offer cancer patients a treatment that prevents side effects and improves the quality of life, in an area of great medical need similar to CIPN with oxaliplatin.

Well attended capital markets day
PledPharma’s first capital markets day, which took place at the end of March, welcomed some 50 investors and analysts on site, whilst even more followed the event directly via the webcast. The capital markets day provided us with an opportunity to give more extensive information about our clinical projects and their potential, which was received positively.

Significant interest from the scientific community
Both our drug candidates have generated interest from the scientific community. The results from Aladote’s® phase Ib/IIa POP study were selected for an oral presentation at one of the largest scientific conferences globally in hepatology (liver diseases), the global conference EASL ILC 2019 in Vienna. Dr James Dear, Principal Investigator, held the presentation on April 12. Furthermore, the conference organizer chose to publish the study results through a press release to the media and the international scientific community as one of the highlights of the day. The results were also presented by Dr. James Dear at a global toxicology conference in Baltimore, USA, organized by the Society of Toxicology in March.
The design of the global Phase III program POLAR for PledOx® was presented at one of the most prominent drug conferences in gastrointestinal cancer; the Global Conference on Gastrointestinal (GI) Cancer Symposium in January in San Francisco. Presenter was Prof. Per Pfeiffer from Odense University Hospital, one of the Coordinating Investigators of the POLAR studies.

Listing on the main market
The process to list our share on Nasdaq Stockholm’s main market is ongoing aiming to be completed in the fourth quarter. The ambition is to create further interest from a broader investor base and reflect the maturity of our business.

Eventful year ahead
The first quarter has meant a good start to the year. With an ongoing PledOx® global Phase III program in the US, EU and Japan, the first milestone payment from our partner, an initiation of an indication expansion program in CIPN with taxanes for PledOx®, the next development phase for Aladote®, the scientific interest in our products, combined with a globally robust IP portfolio for PledOx® and Aladote® and our strong organization, I have great confidence in and look forward to our continued work.

Nicklas Westerholm, CEO
PledPharma AB, Stockholm