Stockholm, 2016-10-20 07:30 CEST (GLOBE NEWSWIRE) -- With PledOx ® to the next level
January – September summary
· Net result for the nine-month period amounted to SEK -26 761 (-35 041) k
· Cash equivalents at the end of the period amounted to SEK 23 590 (59 313) k
· Cash flow from operating activities amounted to SEK -26 770 (-42 201) k
· Result per share amounted to SEK -0.9 (-1.2)
Third quarter summary
· Net result for the quarter amounted to SEK -7 932 (-11 431) k
· Cash equivalents at the end of the quarter amounted to SEK 23 590 (59 313) k
· Cash flow from operating activities amounted to SEK -8 075 (-10 273) k
· Result per share amounted to SEK -0.3 (-0.4)
Significant events during January - September
· 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
· PledPharma announces a guaranteed rights issue of SEK 406 million in order to take PledOx® into phase lll
CEO comment - With PledOx ® to the next level
The Board of Directors and management of PledPharma have decided to develop the Company’s main product, PledOx ® , all the way to application for market registration. This means that we change our strategy and develop the project through pivotal clinical trials, i.e. phase III trials that 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. The reason we have chosen this path is that we expect to create significantly greater value for the shareholders, than what we can realize through a partnership today. The decision follows an over the past year, growing confidence in the project as well as feedback received in constructive discussions with several potential partners who want to see Phase III data. It does involve risk, but our assessment is that this step allows for a significantly increased value of PledOx ® , both as a result of a higher value of completed Phase III studies, as well as that the proportion of the value attributed to PledPharma at a later out-licensing increases significantly.
From an economic stand point, the decision is supported by the assessment made by a reputable international research house after carrying out in-depth interviews with Key Opinion Leaders and representatives of health care payers. The research house estimates global peak sales of PledOx® to USD 1.8 billion, corresponding to approximately SEK 16 billion. The estimate is based solely on prescriptions to patients with colorectal cancer that are treated with the same chemotherapy agents as PledPharma has used in previous clinical trials. Hence, the estimate does not include patients treated for other cancers.
We enter into this with confidence after that the PLIANT study last spring demonstrated a clinically relevant reduction in neuropathy. Since then, our belief in the project has strengthened even further, first with long-term data from the study presented in December 2015 and the readout of survival data in May 2016, followed by both EMA and FDA in dialogue confirming that the next step for the project is Phase III trials.
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 by surgery and chemotherapy. PledOx ® aims to prevent these patients from receiving chronic and debilitating nerve injury.
Implementing these two phase III studies and taking PledOx ® to market registration is estimated to cost approximately SEK 750 million, of which approximately SEK 400 million will be used to take these studies to top-line results in 2020. Top-line results will show treatment outcomes for chronic neuropathies when patients have completed chemotherapy.
Entering into phase III places increased and partly new demands on the organization. We will recruit senior specialists to manage the clinical studies which we expect to start in the middle of next year together with a renowned clinical contract research organization. We do not plan to build a large organization but to continue to work effectively.
Regarding Aladote ® for the treatment of acute paracetamol poisoning, the plan is to out-license the project to commercial partners after clinical proof of concept. The first clinical study is expected to start in the first quarter of 2017. We have also taken the decision to discontinue the project PP 099 to focus on the development of PledOx ® and Aladote ® .
After the rights issue, we will begin preparations to apply for listing on Nasdaq Stockholm's main list. In summary, the decisions we have taken positions PledPharma to create significantly greater value for 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 and positive results from the Phase IIb study PLIANT were presented during the spring of 2015. 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 07:30 CET on October 20 2016.
