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Interim report January – June 2016

August 25, 2016

PledPharma AB
Interim information

Interim report January - June 2016

Stockholm, 2016-08-25 08:30 CEST (GLOBE NEWSWIRE) -- 
Important steps taken with the drug candidates PledOx® and Aladote®

January – June summary

·       Net result for the first half year amounted to SEK -18 829 (-23 610) k

·       Cash equivalents at the end of the period amounted to SEK 31 666 (69
586) k 

·       Cash flow from operating activities amounted to SEK -18 695 (-31 927) k

·       Result per share amounted to SEK -0.7 (-0.8)



Second quarter summary

·       Net result for the quarter amounted to SEK -11 984 (-11 447) k

·       Cash equivalents at the end of the quarter amounted to SEK 31 666 (69
586) k 

·       Cash flow from operating activities amounted to SEK -12 018 (-17 942) k

·       Result per share amounted to SEK -0.4 (-0.4)



Significant events during January - June

·       PledPharma conducted a constructive meeting with the European Medicines
Agency (EMA) 

·       Follow-up data confirms that PledOx® does not negatively interfere with
the anti-cancer effect of chemotherapy 

·       PledPharma presented the Phase IIb PLIANT study data at the American
Society of Clinical Oncology (ASCO) cancer meeting 

·       During the AGM the CEO reported that active discussions are being held
with a number of potential partners in the ongoing process of finding one or
more appropriate commercial partners for the continued development of PledOx®. 


CEO comment

During the second quarter, we continued our work to strengthen the projects
through a number of important steps with our drug candidates PledOx® and
Aladote®. In the PledOx project we have demonstrated additional clarifying data
and made progress in our regulatory discussions. 

The Aladote® project is progressing according to plan and a clinical study,
with the aim to prevent liver damage associated with acetaminophen overdose, is
expected to start in late 2016. 

During the spring we completed a constructive meeting with the European
Medicines Agency (EMA) regarding the remaining development and potential market
introduction of PledOx®. The meeting was a joint meeting attended by
representatives from NICE in the UK and NOMA in Norway, two national
authorities who are responsible for health economic evaluations of new drugs.
We conclude that the European Medicines Agency share our view regarding the
structure and scope of the remaining clinical development of PledOx®. 

We have previously completed a so-called end-of-Phase II/pre-Phase III meeting
with the FDA. Also this meeting was held in a constructive and positive spirit
and altogether has the contacts with the regulatory authorities established a
basis for a clear regulatory strategy for the two largest markets, US and
Europe and a good basis for the continued development. PledPharma’s view is
that these meetings have created a foundation for the way forward towards a
market approval of PledOx® for the prevention of chemotherapy induced nerve
damage in patients treated for colorectal cancer. 

At ASCO in June, PledPharma presented the Phase IIb PLIANT study data
demonstrating the preventing effect on chemotherapy-induced nerve damage of
PledOx®. The results were presented in a Poster Discussion Session by the
study's coordinating primary investigator, Professor Bengt Glimelius. 

During the quarter we presented positive follow-up data from the Phase IIb
study PLIANT where we reported that the so called Progression Free Survival
(PFS) i.e., survival time without tumor growth after the end of treatment is
approximately seven months, which is in line with what can be expected from
this group of patients. No difference in PFS was noted between the patients who
received PledOx® and those who received placebo. The results confirm that
treatment with PledOx® has no negative effect on the efficacy of the cancer
treatment. 

As previously announced, active discussions are held with a number of potential
partners for PledOx®. 

In conclusion, we have strengthened the conditions for the drug candidates
PledOx® and Aladote®. 

Jacques Näsström

CEO, PledPharma AB (publ)



For more information, please contact:

Jacques Näsström, CEO, phone: +46 737 130 979

[email protected]

Michaela Gertz, CFO, phone: +46 709 26 17 75

[email protected]

About PledPharma

PledPharma develop new drugs that protect the body against oxidative stress - a
potentially disabling and sometimes life-threatening condition that can be
caused by chemotherapy and acetaminophen poisoning. The company's most advanced
project PledOx® reduces nerve damage associated with chemotherapy. Positive
results from phase IIb study PLIANT were presented in the spring of 2015. The
drug candidate Aladote® is developed to reduce the risk of acute liver failure
associated with acetaminophen poisoning. The project PP-099 aims to limit the
damage that occurs to the heart muscle during a heart attack. PledPharma
(STO:PLED) is listed on Nasdaq First North. Erik Penser Bank is the Certified
Adviser. For further information, please visit www.pledpharma.se

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Address: Klara Norra Kyrkogata 26, SE 111 22 Stockholm, Sweden

Phone: +46 8 679 72 10

E-mail: [email protected]