Year-end Report January-December 2017
February 22, 2018
Q4 IN BRIEF
- The design of the global pivotal programme for PledOx® was finalized after dialogue with EMA.
- A regional licensing agreement was entered with Solasia Pharma K.K. regarding development and commercialization of PledOx® in Japan, China, Hong Kong, Macau, South Korea and Taiwan.
- Data from PLIANT, a phase IIb trial, was published in Acta Oncologica. Study results indicate that PledOx® can prevent chemotherapy induced neuropathy during and post treatment of colorectal cancer with oxaliplatin.
- Yilmaz Mahshid was recruited as the new CFO.
- SUNCIST, a phase I study with Japanese and Caucasian healthy volunteers was initiated in December to evaluate PledOx® tolerability and pharmacokinetic.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
- Delayed delivery of study drug for the PledOx® phase III-program – top-line results still expected during 2020, in-line with previous communication.
- The US FDA, the central ethics committee in the US and the health authority in the UK, MHRA have accepted the study design for the PledOx® phase III programme.
- PledOx® shows favorable safety and tolerability profile in the SUNCIST Phase I study in Japanese subjects, which merits further clinical development in Asian patients.
- First two patients in the third and final cohort was dosed in the ongoing trial with Aladote®.
FINANCIALS FOR THE QUARTER
- Quarterly result MSEK -32.1 (-11.5)
- Cash position MSEK 309.5 (394.0)
- Cash flow from operating activities
- MSEK -45.4 (-9.3)
- Result per share SEK -0.7 (-0.3)
JAN-DEC IN BRIEF
- Nicklas Westerholm was recruited as the new CEO for PledPharma.
- Christian Sonesson, Stefan Carlsson and Yilmaz Mahshid were recruited as Vice President Product Strategy and Development, Chief Medical Officer and Chief Financial Officer, respectively.
- Marie Ekström Trägårdh, Gunilla Osswald, Elisabeth Svanberg and were elected to the Board of Directors.
- PledPharma started a clinical study with drug candidate Aladote®.
- A Scientific Advisory Board was established for the continued clinical development of PledOx® and had their first meeting.
- PledPharma received advice from the FDA for the continued development of PledOx®.
- PledPharma’s key patent application for the active pharmaceutical ingredient of the drug candidates PledOx® and Aladote® was approved in Japan, Russia and China (earlier approved in the US).
- A warrants program was established.
FINANCIALS FOR THE YEAR
- Loss for the period MSEK -88.0 (-38.2)
- Cash position MSEK 309.5 (394.0)
- Cash flow from operating activities MSEK -86.6 (-36.1)
- Loss per share SEK -1.8 (-1.3)
Comments from the CEO
Our highest priority in 2017 has been to ensure PledOx® is ready for the start of phase III trials. To achieve this important goal, since I became CEO in June, we have focused on strengthening the organization through the recruitment of new employees with complementary skills and experience from late stage drug development, optimizing our development programmes and the dialogues with regulatory agencies. A significant part of our time has also been devoted to securing our first licensing agreement for our most advanced candidate drug PledOx®.
PledPharma’s first commercial Cooperation agreement
In November, we announced that the Japanese pharmaceutical company, Solasia Pharma K.K., is committed to paying up to 83 million dollars for the right to develop and commercialize PledOx® in certain parts of Asia. PledPharma is also entitled to royalties on future sales of the product. In addition, after regulatory interactions, Solasia undertakes to fully finance an expansion of the global phase III programme by inclusion of Asian patients. We see this agreement as an important milestone in PledPharma’s development and an indication of the global commercial potential of the project.
Patient-inclusion in phase III studies with PledOx® during 2018
Following a constructive dialogue with the European Medicines Agency, we were, in November, able to finalise the design of the phase III programme for PledOx®. Preparations for the start of the studies are well advanced and the study design have been approved by the UK Medicines Agency MHRA and accepted by the US FDA and the Central Ethics Committee of the United States. However, due to a delay in delivery of the study drug, the first patient will be included later than we initially expected. Despite this, we still expect to be able to present top-line results in 2020 in accordance with previous communication.
In December, we initiated a clinical Phase I study (SUNCIST) with PledOx® in Asian patients. The positive results that we have recently communicated from this study are intended to allow for an expansion of the phase III programme in order to obtain market approvals of PledOx® also in the large and commercially attractive Asian markets. The phase I study is fully funded by our new partner, Solasia Pharma K.K.
An even stronger PledPharma
During the year we have recruited several new employees to strengthen our competence for the further development and commercialisation of our pharmaceutical projects. Dr. Stefan Carlsson, PledPharma’s new Chief Medical Officer, is responsible for the continued clinical development of our two drug candidates. Dr. Christian Sonesson, new Vice President Product Strategy & Development, has the overall responsibility for PledOx® including responsibility for the design of pricing strategies, initial market positioning and potential indication expansions. Dr. Yilmaz Mahshid, who recently joined as the CFO, will lead Pledpharma’s financial management and investor relations, as well as facilitate our corporate strategy development.
PledPharma’s Scientific Advisory Board (SAB), which was set up in the autumn, will provide us with valuable advice on the design of the clinical trial programme and the regulatory strategy for PledOx®, with the goal of maximizing the likelihood for regulatory approval and optimizing the drug candidate’s commercial potential. The SAB consists of five renowned international experts in the fields of oncology, neurology and patient-reported evaluation. We see the commitment of these experts as a clear indication of the medical need to be able to prevent chemotherapy induced nerve damage, and at the innovation height of our project.
Clinical Study with Aladote®
The clinical proof of principle-study with Aladote® initiated in spring of 2017 in patients who had inadvertently or deliberately overdosed paracetamol progresses according to plan. In February 2018, two patients have been included in the third and final dose cohort of the study. Results from this study will provide us with valuable guidance on the decision for the continued development and commercial strategy. Today, there is no effective treatment for the significant proportion of patients who seek medical care post 8 hours after overdose.
Significant potential for value creation
We look forward to include the first patient in the phase III program with PledOx® during 2018, presenting clinical proof of principle data for Aladote® and continue our efforts to create the best possible conditions for future potential commercial agreements. The need for a treatment which can prevent nerve damage associated with chemotherapy, as well as an effective medicine that can prevent acute liver failure caused by paracetamol poisoning, is significant. PledPharma has two advanced clinical projects with the potential to revolutionize treatment for both of these patient categories, and thus have the opportunity to generate substantial values for shareholders.
Nicklas Westerholm, CEO
For further information, please contact:
Nicklas Westerholm, CEO
Tel: 073-354 20 62
Yilmaz Mahshid, CFO
Tel: 072-231 68 00
This information is such information as PledPharma AB (publ) is obliged to disclose in accordance with EU market abuse regulation and the Securities Markets Act. The information was submitted, through the above contact persons, for publication on 22 February 2018 at 8.00 am (CET).
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® is being developed to reduce nerve damage associated with chemotherapy. A phase IIb study has been conducted and is serving the basis for the upcoming phase III program. 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. The company´s Certified Advisor is Erik Penser Bank (phone +46 8 463 80 00).