Interim Report January-September 2018

Summary

JULY-SEPTEMBER IN BRIEF

• PledPharma announces positive results from the Aladote^® proof of principle study
• The Scientific Advisory Board for Aladote^® held its first meeting with focus on the design of the next study
• Study drug to PledPharma’s global phase III program with PledOx^® was delivered and first patient is expected to be enrolled during the fourth quarter

SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD

• During October, all supplementary clinical trial applications for PledOx^® will be amended, with final study drug data, to health authorities in countries participating in the phase III studies.

FINANCIALS FOR THE QUARTER, JULY-SEPTEMBER 

• Quarterly result MSEK -18.8 (-27.3)
• Cash flow from operating activities
  MSEK -17.4 (-9.6)
• Result per share SEK -0.4 (-0.6)

JANUARY-SEPTEMBER IN BRIEF

PledOx^®

• Positive results from the SUNCIST-study where PledOx^® were administered to Caucasian and Japanese healthy volunteers were communicated in February
• The European and the US clinical investigator meetings for the POLAR studies was held in Barcelona, Spain and Orlando, USA
• European Medicines Agency (EMA) approved PledPharma’s waiver application for the pediatric investigation plan (PIP)
• Japanese Medical Agency (PMDA) supports the expansion of the Phase III program for PledOx^® to include Japanese patients

Aladote^®

• PledPharma announces positive results from the Aladote^® proof of principle study, the study was fully recruited in May and subsequently the drug was concluded as safe in June
• The Scientific Advisory Board for Aladote^® held its first meeting with focus on the design of the next study

FINANCIALS FOR THE PERIOD, JANUARY-SEPTEMBER

• Loss for the period MSEK -62.9 (-55.8)
• Cash position MSEK 250.3 (354.3)
• Cash flow from operating activities
  MSEK -59.9 (-41.2)
• Result per share SEK -1.3 (-1.1)

Comments from the CEO

Positive study data for Aladote® enables further clinical development
Positive results from the clinical proof of principle study with Aladote® - a drug candidate for the treatment of acute liver damage post paracetamol poisoning - were reported in September. Aladote®’s good safety results and benign dose limiting side effect profile were already reported in June. The positive results in the final report shows that treatment with Aladote® in combination with current standard of care (NAC) may reduce liver damage in the specific patient population in comparison to treatment with NAC alone. These findings are based on results from measurements of two explorative biomarkers for liver damage, both are accepted as biomarkers in drug development for the prevention of liver damage by the health agencies in the US and Europe.

We are encouraged by the promising results and have, together with our internationally renown advisory board for Aladote^®, initiated an extensive work to design and plan the next study. In parallel, we are preparing our Orphan Drug Designation application for the US.

Paracetamol is a pharmaceutical drug that is commonly overdosed – intentional and unintentional – and can cause life threatening liver damage. Current standard of care (NAC) is most efficient given within 8 hours of paracetamol overdose. There is a lack of efficient treatment for patients who arrive later than 8 hours to the hospital.

PledOx^® phase III study is planned to be initiated in the fourth quarter
The phase III program for PledOx^® now consists of two double-blind, randomised, placebo-controlled studies, POLAR-M and POLAR-A. POLAR-M includes 420 patients undergoing chemotherapy treatment for metastatic colorectal cancer and is planned to be conducted in Europe, Asia and the United States. POLAR-A includes 280 patients undergoing adjuvant chemotherapy treatment for colorectal cancer and planned to be conducted in Europe and Asia.

During the quarter, PledOx^® - a drug candidate with the potential to reduce the risk for chemotherpay induced peripheral neuropathy - study drug was successfully produced and delivered. All submitted clinical trial applications to health authorities will be amended during October with data from the newly produced study drug. PledPharma is well-prepared to include patients as soon as necessary approvals are in place. Based on updated feasibility studies of patient recruitment at study centers, the expectation is to complete recruitment within 10-12 months from study start.

Current standard of care treatment regime for colorectal cancer includes the chemotherapy oxaliplatin. Oxaliplatin is associated with dose-limiting and debilitating nerve damages. These nerve damages affect 40 to 60 percent of the patients during and after treatment, of which 20 to 30 percent of the patients have long-lasting side effects. Currently, there are no market approved prophylactic or alleviating treatments.

Important milestones in the fourth quarter
Recent achievements enable us to dose the first patients in the global phase III program for PledOx^® during the fourth quarter. And we do also look forward to finalise the design for the next study with Aladote^®. These are important and value creating milestones in our journey towards our set goals – to address the unmet medical need in these two patient populations.

Nicklas Westerholm, CEO
Pledpharma AB
Stockholm

For further information contact:

Nicklas Westerholm, President and CEO          Yilmaz Mahshid, CFO       
Phone: +46 73 354 20 62                             Phone: +46 72 231 68 00
E-mail: nicklas.westerholm@pledpharma.se     E-mail: yilmaz.mahshid@pledpharma.se

This information is such information as PledPharma AB (publ) is obliged to disclose in accordance with EU market abuse regulation and the Securities Markets Act. The information was submitted, through the above contact persons, for publication on 23 October 2018 at 8.00 am (CET).

PLEDPHARMA IN BRIEF
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 serves as the basis for the initiated phase III program. The drug candidate Aladote^® is being developed to reduce the risk of acute liver failure associated with acetaminophen poisoning. A proof of principle study has been successfully completed and will serve as the basis for the continued development. PledPharma (STO:PLED) is listed on Nasdaq First North.

Attachment

• Q3 18 rapport Eng final