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Egetis is an innovative and integrated pharmaceutical company, focusing on projects in late-stage development for commercialization for treatments of serious diseases with significant unmet medical needs in the orphan drug segment

Interim report third quarter 2015

October 20, 2015

PledPharma AB
Interim information

Interim report third quarter 2015


Stockholm, 2015-10-20 08:30 CEST (GLOBE NEWSWIRE) -- 

Significant events during the quarter

  -- Net result for the quarter amounted to SEK 
-11 431 (-
11 265
) k and to -35 025
30 714
) k for the nine-month period
  -- Cash and cash equivalents at the end of the period amounted to SEK 
59 313
40 675
) k 

  -- Cash flow from operating activities for the quarter amounted to SEK -10 273
-7 124
) k and to -41 939 (-
28 808
) k for the nine-month period
  -- Result per share for the quarter amounted to SEK 
-0.4 (-0.5) and to -1.2 (-1.4) for the nine-month period
  -- PledPharma's key patent application for the active pharmaceutical
     ingredient of the drug candidates PledOx
 and Aladote
 has received a "Notice of Allowance" from the United States Patent and
     Trademark Office (USPTO) meaning that the USPTO intends to grant the
  -- Patent for
 the anticancer-effect of PLED compounds approved by the European Patent
     Office and an important use patent for PLED compounds granted by
     authorities in Canada, Russia and Australia.
  -- Aladote
 approved as a trademark in the US

Other significant events during 2015

  -- Top-line results from phase IIb study presented in March - PledOx
 reduces nerve damage in conjunction with chemotherapy by 43 percent
  -- Aladote
 approved as a trademark in the EU
  -- Further clinically relevant and statistically significant results
 from the Phase IIb study with PledOx
 at the MASCC scientific congress.

CEO comment

Earlier this year PledPharma presented groundbreaking results from a Phase IIb
study of PledOx®. During the last quarter, intensive work has been ongoing on
the completion of the comprehensive briefing package to be discussed at the
upcoming meeting with the FDA. The goal of the meeting is to clarify the scope
and design of the continued clinical development studies needed up to
submission of a registration application. After this, we are ready to intensify
discussions with potential commercial partners. Ahead of this important phase,
we also commissioned a group of leading international experts, with extensive
experience and deep knowledge of the global pharmaceutical industry's
requirements, to perform an analysis of the project from a preclinical,
clinical, pharmacological, manufacturing, and regulatory perspective. The
analysis confirms that the PledOx® project confirms to a very high
international standard and that no additional activities are deemed necessary
before contract negotiations. 

The commercial value of these results will of course be significantly higher if
they can be combined with strong intellectual property protection. It is
therefore rewarding that intellectual property protection for PledOx® has
strengthened further during the past quarter. In September, the US Patent
Office, USPTO, announced that it intends to grant a compound patent covering
the active ingredient calmangafodipir. A composition of matter (compound)
patent is normally the most desirable form of patents for pharmaceutical
companies because it offers stronger protection than use patents. Getting our
compound patent - which extends until December 2032 - issued on the world's
largest pharmaceutical market is a very big step for PledPharma. Since another
of our drug candidates - Aladote® - is based on the same active pharmaceutical
ingredient as PledOx®, the announcement from the patent authorities is also of
great value for this project. Aladote® has been developed to prevent the severe
liver damage that often occurs in connection with an overdose of acetaminophen
- the most common method for suicide attempts among young people aged 10-19
years. A clinical phase II study is expected to be initiated during in 2016. 

Furthermore, patent protection in other parts of the world has been
strengthened by a series of positive official statements. The European Patent
Office has approved a patent for the anti-cancer effect of PLED substances.
Thus, this patent is now approved in all major pharmaceutical markets.
Meanwhile, authorities in Canada, Russia and Australia granted an important use
patent for PLED substances. Together, these two patents provide supplementary
protection around the central and fundamental compound patent. 

I look forward to the meeting with the FDA, which will give us guidance on how
to present an attractive package to potential partners based on a
professionally executed project with unique clinical results, a strong patent
position, and a well-defined development plan. The aim is to achieve an
agreement that maximizes our ability to quickly and effectively make PledOx®
available for the long-suffering of cancer patients, while at the same time
building significant value for our shareholders. 

Jacques Näsström

CEO, PledPharma AB (publ)

PledPharma in brief

PledPharma develops new drugs that protect the body against oxidative stress –
a condition that can be caused by chemotherapy treatment and acetaminophen
(paracetamol) poisoning. The company's most advanced project PledOx® reduces
nerve damage associated with chemotherapy. The drug candidate Aladote® is being
developed to reduce the risk of acute liver failure associated with
acetaminophen poisoning. The project PP-099 seeks to limit the damage that
occurs to the heart muscle during myocardial infarction. PledPharma’s most
advanced project with PledOx® has completed Phase II trial. PledPharma (STO:
PLED) is listed on Nasdaq First North. Erik Penser Bankaktiebolag is the
company’s Certified Adviser (tel +46 8 463 80 00). For more information, see 

For further information contact:
Jacques Näsström, CEO cell +46 73 713 09 79

Johan Stuart, CFO cell +46 70 66 44 096



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Phone: +46 8 679 72 10