News room

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

PledPharma AB (publ) Interim report January-September 2012

October 26, 2012

PledPharma AB
Company Announcement

PledPharma AB (publ)  Interim report January-September 2012

Patient screening ongoing ahead of inclusion in the PledOx™ Phase IIb study

Stockholm, 2012-10-26 08:30 CEST (GLOBE NEWSWIRE) -- 

The period July – September

·      The design of the clinical study for PledOx has been approved by the
Swedish Medical Products Agency (MPA) 

·      Selection of patients ongoing at Uppsala University Hospital and
Karolinska University Hospital in Solna and for inclusion in the PledOx Phase
IIb study in colorectal cancer 

·      Participating clinics in the PledOx study have been chosen. Around 30
high-quality clinics in eight countries, including Sweden and the US, will
participate in the study 

·      Net result amounted to SEK -5 642k (-2 485k)

·      Cash and cash equivalents on Sept 30 was SEK 65 487k (97 659k)

·      Cash flow from operating activities amounted to SEK -3 121k (-5 659k)

·      Result per share amounted to SEK -0.28 (-0.12)

 The period January – September in summary

·      Net result amounted to SEK -25 467k (-7 820k)

·      Cash flow from operating activities amounted to SEK -25 010k (-7 284k)

·      Result per share amounted to SEK -1.26 (-0.39)

·      Professor Bengt Glimelius at Uppsala University Hospital, a world
authority within research and treatment of cancer, coordinating principal
investigator of the PledOx study 

·      Positive results in the long term preclinical PledOx safety studies

·      A new composition of matter patent application for PledOx provides
additional strong and extended patent protection opportunities 

·      Positive and supportive meetings with the MPA and the US regulatory
authority (FDA) regarding the PledOx study 

·      Publication of clinical study, showing a decreased number of serious
adverse events due to chemotherapy in patients pretreated with PLED-substance,
in a scientific journal 

CEO comments

“Patient screening is ongoing in the open dose-escalation phase of the study at
Karolinska University Hospital in Solna and Uppsala University Hospital. We
expect to include the first patient in the coming month. Nine to twelve
patients will be included in this part of the PledOx study until the beginning
of 2013. The other clinics will start thereafter”, says CEO Jacques Näsström. 

For further information please contact:
Erik Kinnman, VP Investor Relations, cell + 46 73 422 15 40

Johan Stuart, CFO, cell +46 70 66 44 096

Jacques Näsström, CEO cell +46 73 713 09 79

About PledPharma

PledPharma is a Swedish specialty pharma company that develops a new medicine,
PledOx™, for prevention of the severe side effects that patients develop as a
consequence of chemotherapy treatment of cancer. Many times the treatment
cannot be carried out as planned due to very difficult side effects. The
current market for supportive cancer care is some SEK 72 billion. PledOx is a
medicine within the patent protected substance class PLED, which protects the
body’s normal cells against oxidative stress. Oxidative stress is a condition
where an overabundance of harmful oxygen molecules (free oxygen radicals) has
been formed. We are also evaluating opportunities with PLED substances for
other diseases. PledPharma (STO:PLED) is listed on NASDAQ OMX First North. Erik
Penser Bankaktiebolag is the Certified Adviser. For more information, please



Contact us

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

Phone: +46 8 679 72 10