Year-end report January-December 2019
February 18, 2020
PledPharma presents the fourth quarter and the year-end report 2019
· Quarterly net sales MSEK 17.1 (11.2)
· Quarterly results MSEK -23.0 (-22.1)
· Cash and cash equivalents MSEK 255.1 (229.9)
· Cash flow for the quarter MSEK -29.1 (‐20.6)
· Result per share before and after dilution SEK -0.4 (-0.5)
· PledPharma’s shares commenced trading on the Nasdaq Stockholm main market
· Global phase III study POLAR-A fully recruited
· PledPharma and Solasia entered a second license agreement for the development and commercialization of PledOx® in Asia, targeting neuropathy caused by taxanes and any other chemotherapy
· PledPharma’s Asian partner Solasia entered an agreement with Japanese Maruho for commercialization of PledOx® in Japan
· Regulatory meetings held with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for advice and discussion on the Aladote development program and path to a possible market approval
January-December in brief
· PledPharma received MJPY 600, ca. MSEK 49, in milestone payment due to the inclusion of the first Asian patient into the global Phase III program for PledOx®
· Aladote® has been granted Orphan Drug Designation by FDA
· PledPharma initiated an indication expansion program for PledOx® in CIPN associated with taxanes
· PledPharma completed a directed new share Issue of 4,866,665 shares, raising proceeds of SEK 91 million
· The results of the proof of principle study with Aladote were published in the Lancet’s journal EBioMedicine
· PledPharma and Solasia entered a second license agreement
· Trading in PledPharma’s shares commenced on the Nasdaq Stockholm main market
· Global phase III study POLAR-A fully recruited
Significant events after the reporting period
· FDA issued a clinical hold in the US of the phase III POLAR-M study
Comments from the CEO
2019 was in many respects an intense and interesting year, both for the company and our clinical projects PledOx® and Aladote®. The global Phase III study POLAR-A with PledOx, for the prevention of nerve damage associated with chemotherapy (CIPN), was fully recruited and top line results are expected Q1-2021.
In January 2020, we experienced a setback when the FDA issued a clinical hold in the US of the POLAR-M study. The decision by the FDA is due to their review of a few numbers of observed adverse events. Therefore, recruitment and dosing of patients is halted in the US. Based on the detailed evaluation of the independent Drug Safety Monitoring Board (DSMB), as well as available clinical and pre-clinical data, our position is that the overall safety profile for PledOx supports the continuation of the POLAR program.
POLAR-M, is progressing in EU and Asia, conducted in 420 patients with more progressed disease and is taking a little longer time. POLAR-M is expected to be fully recruited in Q2 2020.
We will continue to work with the FDA to provide the necessary information to lift the clinical hold. All other regulatory authorities involved in the POLAR program have been informed about the US clinical hold. We continue to have dialogue with the involved authorities. DSMB held an ordinary meeting in the second week of Feb and recommend that the POLAR program continue without modification.
Expanded Asian collaboration
In 2019, we also continued to move forward with our fruitful collaboration with our Japanese partner Solasia Pharma. In October, we signed a second license agreement for the development and commercialization of PledOx in Asia, targeting neuropathy caused by taxanes and any other chemotherapy. The agreement includes an upfront payment, as well as development and regulatory milestones to PledPharma of up to approximately SEK 165 million, as well as sales milestones and royalties. This is on top of the first agreement from November 2017, which included development and sales milestone payments of up to approximately SEK 700 million. To date, PledPharma has received in total approximately SEK 65 million from Solasia in upfront and milestone payments, and in addition, Solasia is paying for the recruitment of patients to the POLAR program in Asia
The new agreement follows our initiated indication expansion program in CIPN caused by taxanes, where preclinical studies are already ongoing to guide further development into a clinical stage. There is a large unmet medical need preventing CIPN caused by taxanes, similar to CIPN triggered by oxaliplatin, where we see an additional substantial potential for PledOx. This is a key step in broadening our pipeline of development projects. We are very pleased with this important license agreement which deepens our collaboration with Solasia.
In December, Solasia also signed an exclusive license agreement with the Japanese pharmaceutical company Maruho for commercialization of PledOx for the treatment of CIPN in Japan. Under the agreement, Maruho will commercialize PledOx exclusively in Japan after Solasia and PledPharma complete development of the product in Japan. This agreement is a further strong validation of the potential for PledOx to address chemotherapy induced nerve damage.
Progress with Aladote
The other important asset of our portfolio is Aladote In 2019 we continued to further advance this drug candidate, in development for reducing liver damage due to paracetamol overdose. In March, we received an Orphan Drug Designation (ODD) by the FDA for Aladote. The ODD status can benefit patients by potentially resulting in shorter development time.
Aladote has continuously caught the interest of the scientific community. In April, it was highlighted for a presentation at the global scientific conference EASL ILC, also known as The International Liver Congress, which is one of the largest scientific conferences in the field of liver diseases globally. In July, the results of our proof-of-principle study with Aladote were published in the Lancet’s EBioMedicine. This journal sets very high standards for publishing and selects only the most important research results based on its quality and scientific impact. We see both these events as yet further confirmation that Aladote generates great interest potentially to meet the unmet medical need for the treatment of paracetamol poisoning beyond current standard of care.
Following interactions with both the FDA and EMA, early in January this year, we announced a development path forward with one pivotal Phase II/III study with Aladote for marketing authorization application in both the US and EU.
Listing on the main market
In parallel with our work advancing our clinical projects, we were involved in lots of other activities that ultimately benefit the company, the shareholders and other stakeholders, including arranging a well-attended Capital Markets Day in Stockholm, completing a successful rights issue of SEK 91 million in May, and on October 31, making the important transition to the Nasdaq Stockholm’s main list. Listing on Nasdaq Stockholm’s main list is a natural step in the company’s development that confirms the maturity of our business and increases awareness of the company. With a listing on a regulated market, PledPharma also becomes more accessible and attractive to both Swedish and international institutional investors.
Looking ahead, full focus will of course be on the development of our prioritized drug candidates PledOx and Aladote. The safety of patients in our clinical studies is our most important responsibility. We continue to work with the FDA on the issue around the clinical hold of POLAR-M in the US and the continued development with Aladote. I look forward to updating you on our continued progress.
Nicklas Westerholm, CEO
PledPharma AB, Stockholm