Interim Report Third Quarter 2013
October 25, 2013
PledPharma AB
Interim information
Interim Report Third Quarter 2013
Stockholm, 2013-10-25 08:00 CEST (GLOBE NEWSWIRE) --
Significant events after the end of the period
· All patients required to initiate the second part of the Phase IIb study
PLIANT have been
included
· Promising results from the acute myocardial infarction study MANAMI
· Patent from PledPharma’s second series of worldwide applications has
been approved in
South Africa, as the first country.
· PledOx® registered as a trademark in Japan
Significant events during July - September
· Patent for the use of PLED compounds in the treatment of cancer approved
in China
· Net result amounted to SEK -4 509k (-5 642k)
· Cash and cash equivalents on September 30 amounted to SEK 54 910k (65
487k)
· Cash flow from operating activities amounted to SEK -4 207k (-3 121k)
· Result per share amounted to SEK -0.2 (-0.3)
Significant events during January – September
· Patent application for the use of PLED compounds in the treatment of
cancer approved
and issued in the US and Russia
· FDA approved IND application for the clinical trial PLIANT in the US
· Rights issue provided the company with 18.6 million SEK.
· IMS Consulting Group appointed advisor for the commercialization of
PledOx®
· Sten Nilsson, MD, PhD Professor of Oncology at Karolinska University
Hospital and
Institutet in Stockholm elected as member of the board.
· PledOx® registered as a trademark in the US, Switzerland and Australia
· Net result amounted to SEK -18 588k (-25 467k)
· Cash flow from operating activities amounted to SEK -22 459k (-25 010k)
· Result per share amounted to SEK -0.8 (-1.3)
CEO comments
The myocardial infarction study MANAMI is completed and the results show that
the PLED substance was well tolerated by patients in the study and can be given
safely to seriously ill cardiac patients without any side effects. Despite the
study's limited size, a tendency towards clinical effect was seen.
MANAMI is a small study in a very large and difficult disease area. As
PledPharma has previously communicated, we have chosen to focus our resources
on the oncology project. However, based on these results we will now evaluate
the commercial potential of the myocardial infarction indication.
In the oncology study PLIANT the last out of six patients in the dose
escalation part, is under treatment with PledOx. When this sixth patient has
been treated with the third dose and the Drug Safety Monitoring Board (DSMB)
once again concur, then the randomized part of the study with 126 patients from
approximately 30 centers in Europe and the United States can start. If
everything goes according to plan, a decision by the DSMB to start the second
part can be expected during the week commencing with November 11.
When the dose escalation part has been completed, the data from this open part
of the study will be analyzed and presented separately. Overall, patients have
then been treated with more than 40 doses PledOx in conjunction with
chemotherapy and all patients have tolerated PledOx well, says CEO Jacques
Näsström.
For further information please contact:
Jacques Näsström, CEO PledPharma, phone +46 73 713 09 79
About PledPharma
PledPharma is a Swedish specialty pharma company that develops PledOx® for
prevention of severe chemotherapy-induced side effects in cancer patients. Due
to these side effects optimal treatment cannot be carried out. The current
market for supportive cancer care is some SEK 72 billion. PledOx protects
normal cells against oxidative stress. It belongs to a group of compounds named
lowMEM (low Molecular Enzyme Mimetics), and mimics the enzyme Manganese
SuperOxide Distmutase (MnSOD) – the most important endogenous cellular
protectant against devastating oxidative stress. Oxidative stress is a
condition caused by harmful oxygen/nitrogen molecules, e.g., as a result of
chemotherapy treatment. The company is also evaluating opportunities of using
PLED substances in other diseases. PledPharma (STO:PLED) is listed on NASDAQ
OMX First North. Erik Penser Bankaktiebolag is the Certified Adviser. For
further information, please visit www.pledpharma.se
