Stockholm, 2017-02-24 08:00 CET (GLOBE NEWSWIRE) -- Preparations for the Phase III program with PledOx ®
January – December summary
· Net result for the year amounted to KSEK -38 223 (-43 836)
· Cash equivalents at the end of the period amounted to KSEK 393 998 (50 360)
· Cash flow from operating activities amounted to KSEK -36 115 (-51 153)
· Result per share amounted to SEK -1.3 (-1.5)
Fourth quarter summary
· Net result for the quarter amounted to KSEK -11 462 (-8 794)
· Cash equivalents at the end of the quarter amounted to KSEK 393 998 (50 360)
· Cash flow from operating activities amounted to KSEK -9 344 (-8 953)
· Result per share amounted to SEK -0.3 (-0.3)
Significant events during the year
· PledPharma completed a guaranteed rights issue of SEK 406 million in order to take PledOx ® into phase lll
· PledPharma conducted a constructive meeting with the European Medicines Agency (EMA)
· Follow-up data indicates 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
Significant events after the end of the period
· Gunilla Osswald and Elisabeth Svanberg were elected to the Board of Directors. Håkan Åström and Sten Nilsson will remain on the board.
CEO comment
In 2016 we decided to develop our main product, PledOx ® , towards an application for market registration. This means that we will start pivotal clinical trials, i.e. phase III trials in patients with colorectal cancer during this year. The results from these studies will form the basis for a new drug application (NDA) to the Food and Drug Administration (“FDA”) in the US and for a marketing authorization application (MAA) to the European Medicines Agency (“EMA”) in Europe and as a base for discussions with potential partners. To finance the phase III studies up to top-line results we conducted a new rights issue during the fall.
The results from the Phase IIb study PLIANT has been met with great interest by both clinicians and potential partners. The results were presented in June at the American Society of Clinical Oncology (ASCO), by the study's lead investigator Professor Bengt Glimelius. The follow-up data presented during the year confirms that PledOx ® provides a clinically meaningful reduction of neuropathy compared with the placebo group. Long-term follow-up also showed that PledOx ® has no apparent negative impact on the anti-cancer effect of the chemotherapy.
During the year, we also had a constructive discussion with EMA regarding the continued clinical development of PledOx ® where we received confirmation that the next development stage for PledOx ® is Phase III. Several potential partners have, however, expressed a wish for additional studies, with patient-reported neuropathy as the primary endpoint, before they are ready for further business discussions. PledPharma has therefore decided to move forward into clinical development by ourselves and thereby create added value in the company.
Since last autumn, there are a series of ongoing activities in preparation for the start of the Phase III studies – that among other things include design of the studies, regulatory preparations and manufacturing.
The previous studies with PledOx ® were performed in patients with metastatic colorectal cancer but as we move into Phase III we will, in addition to metastatic colorectal cancer patients, also include patients treated adjuvantly for colorectal cancer. These patients have great potential to be cured from their cancer. PledOx ® aims to prevent these patients from receiving chronic and debilitating chemotherapy induced nerve injury.
In February this year Gunilla Osswald and Elisabeth Svanberg were elected as new board members to strengthen the expertise in phase III clinical development. Gunilla (PhD in Biopharmaceutics and Pharmacokinetics) has extensive experience in preclinical and clinical drug development, in big pharma and smaller biotech companies and is the CEO at BioArctic AB. Elisabeth (MD, PhD and associate professor of surgery) has extensive experience from leading positions at e.g. Bristol-Myers Squibb and Janssen Pharmaceuticals and is the Chief Development Officer at Ixaltis SA.
In 2016, we furthermore worked on the preparations for the start of a proof of principle study with Aladote ® - a drug candidate with the potential to prevent liver damage in connection with overdosing of paracetamol/acetaminophen. The study aims to identify the possibility to add Aladote ® to the existing treatment for acetaminophen poisoning.
In 2017, when PledPharma moves into Phase III with PledOx ® and furthermore takes Aladote ® into a proof of principle study, this means that PledPharma will have two potential first-in-class drugs in clinical development. We are confident that this will create significant value for our shareholders.
Jacques Näsström , CEO, PledPharma AB (publ)
For more information, please contact :
Jacques Näsström, CEO, phone: +46 737 130 979
Michaela Gertz, CFO, phone: +46 709 26 17 75
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 ® reduces nerve damage associated with chemotherapy. A phase IIb study has been conducted and will serve as the basis for the continued phase III 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
This information is information that PledPharma AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CET on February 24 2017
