Interim report January – September 2017
October 20, 2017
PledPharma AB
Interim information
Interim report January - September 2017
Stockholm, 2017-10-20 08:00 CEST (GLOBE NEWSWIRE) --
Q3 IN BRIEF
-- PledPharma established a scientific advisory board for the PledOx® program
and conducted its first meeting.
-- The dialogue with EMA regarding the design of the PledOx® clinical program
is in the final stage
-- A collaboration with a contract research organization has been initiated
for the execution of the PledOx® clinical program
-- PledPharma recruited Stefan Carlsson as new Chief Medical Officer
-- Approval from Data Safety and Monitoring Board for start of recruitment in
the second cohort in the Proof of Principle study with Aladote®
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
-- Calmangafodipir as a potential new treatment of acute liver failure is
presented at a conference on liver disease
-- Dosage of patients has been initiated in the second dose group in the Proof
of Principle study with Aladote®
FINANCIALS
-- Quarterly result MSEK -27,3 (-7,9)
-- Cash MSEK 354,3 (23,6)
-- Cash flow from operating activities MSEK -9,4 (-8,1)
-- Result per share SEK -0,6 (-0,3)
JAN-SEPT IN BRIEF
-- Nicklas Westerholm was recruited as the new CEO for PledPharma
-- Christian Sonesson was recruited as Vice President Product Strategy and
Development
-- Gunilla Osswald, Elisabeth Svanberg and Marie Ekström Trägårdh were elected
to the Board of Directors.
-- PledPharma received advice from the FDA for the continued development of
PledOx® and is now following up with the EMA for the implementation of a
global clinical program.
-- PledPharma's key patent application for the active pharmaceutical
ingredient of the drug candidates PledOx® and Aladote® was approved in
Japan, Russia and China (earlier approved in the US).
-- Patent for the anticancer-effect of PLED compounds was approved in Canada
and an important use patent for PLED compounds was approved in Israel.
-- PledPharma started a clinical study with drug candidate Aladote®.
FINANCIALS JAN-SEPT
-- Result for the period MSEK -55,8 (-26,8)
-- Cash MSEK 354,3 (23,6)
-- Cash flow from operating activities MSEK -39,7 (-26,8)
-- Result per share SEK-1,1 (-0,9)
-- A warrants program was established
COMMENTS FROM THE CEO
PledPharma has during the quarter continued its focus on finalizing the design
of the clinical development program for PledOx®, our unique drug candidate for
preventing chemotherapy induced nerve damage. At the same time, we continue to
see good progress in our ongoing clinical trial with Aladote®.
PledOx® - constructive dialogue with EMA
The dialogue with the European Regulatory Authority EMA regarding the design of
the continued clinical development for PledOx® remains constructive and is in
its final stage.
The discussion has been supported by the expertise we have gathered from our
newly established Scientific Advisory Board, which consists of five renowned
international experts in the fields of oncology, neurology and patient-reported
evaluation.
Work has progressed so that we, following a thorough procurement, have entered
a collaboration with an international contract research organization (CRO) as
we strive for a rapid initiation of the remaining clinical studies after the
regulatory discussion with the EMA has been finalized. Therefore, we see
project start-up costs flowing through the quarter.
Aladote® study proceeding well, the second patient cohort has now started
During the quarter, we have taken clear steps forward in the development of
Aladote®, a drug candidate developed to prevent liver damage associated with
paracetamol poisoning(overdose). After completing the dosing of the first 8
patients DSMB gave approval to start the next group, the second patient cohort,
in the proof of principle study conducted in Scotland under the leadership of a
leading expert in the field, Dr James Dear.
In addition, Dr Dear will present the preclinical study which served as a base
for the ongoing clinical study, as well as in-depth information on the clinical
study's design at the American Association for the Study of Liver Diseases
(AASLD).
PledPharma strengthens the organization and its capabilities
In August, Dr. Christian Sonesson took over the position of Vice President
Product & Strategy Development and on October 30, we welcome our new Chief
Medical Officer, Dr. Stefan Carlsson. Christian and Stefan brings valuable
expertise and experience in their respective areas of responsibility. The
recruitments, which have increased staff costs for the company, are important
in ensuring the expertise to continue to drive PledPharma's development
programs and will to a certain extent be mitigated with reduced costs for
external consultants.
We have important milestones, with value-added potential in front of us and
expect soon to present a well-founded plan for the continued clinical
development of PledOx®, based on our interactions with regulatory agencies and
our scientific advisory board. By the beginning of 2018, we expect the results
from the clinical trial with Aladote®.
Nicklas Westerholm
CEO
For more information, please contact:
Nicklas Westerholm, CEO, phone: +46 73 354 20 62
[email protected]
Michaela Gertz, CFO, phone: +46 709 26 17 75
[email protected]
This information is information that PledPharma AB (publ) is obliged to make
public pursuant to the EU Market Abuse Regulation. The information was
submitted for publication, through the agency of the contact person set out
above, at 08:00 on October 20 2017.
About PledPharma
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 will serve as the basis for the continued development. The drug
candidate Aladote® is being developed to reduce the risk of acute liver failure
associated with acetaminophen poisoning. PledPharma (STO: PLED) is listed on
Nasdaq First North. Erik Penser Bank is the company’s Certified Adviser (tel
+46 8 463 80 00). For more information, see www.pledpharma.se
