Interim report January-September 2019

July-September

· Quarterly net sales MSEK 6.2 (6.7)

· Quarterly results MSEK -31.9 (-18.8)

· Cash and cash equivalents MSEK 286.7 (250.3)

· Cash flow for the quarter MSEK -35.9 (‑16.1)

· Result per share before and after dilution SEK -0.6 (-0.4)

PledOx®

· Patient recruitment to the global phase III studies POLAR-A and POLAR-M is well underway. Recruitment in POLAR-A is expected to be completed before year end 2019, with top line results before year end 2020, as previously communicated. POLAR-M is expected to be fully recruited by Q2 2020

· The independent Data and Safety Monitoring Board (DSMB) held its first meeting and recommended that the POLAR program could continue without modification

Aladote®

· PledPharma has been granted a meeting with the FDA for the fourth quarter for advice and discussion on the next Aladote study and path to a possible market approval. A meeting with the European Medicines Agency, EMA, will take place during the same period

· The results of the proof of principle study with Aladote were published in the Lancet’s journal EBioMedicine, one of the most prominent biomedical research journals

January-September 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

Significant events after the reporting period

· PledPharma and Solasia entered a second license agreement for the development and commercialisation of PledOx® in Asia, targeting neuropathy caused by taxanes and any other chemotherapy

· Nasdaq Stockholm’s Listing Committee has approved the admission of the company’s shares for trading on the main market of Nasdaq Stockholm, subject to customary conditions

Comments from the CEO

Recruitment in POLAR-A is expected to be completed before year end 2019

In and just after the third quarter of 2019, we passed a number of significant milestones, both for the company and our clinical projects PledOx® and Aladote®.

POLAR-A part of PledOx Global Phase III program expects to be fully recruited before year end 2019

We are on target to complete the recruitment of the 280 patients in the POLAR-A study. This is an important milestone for us, which paves the way to top-line results by the end of 2020 as previously communicated. The second study, POLAR-M (420 patients), conducted in patients with more progressed disease is taking a little longer time. POLAR-M is expected to be fully recruited in Q2 2020, and it is anticipated that we will have top line results approximately a year later.

Second license agreement with Solasia Pharma

After the period, in October, we signed a second license agreement with Solasia, covering chemotherapy induced peripheral neuropathy (CIPN) 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 MSEK 165, as well as sales milestones and royalties.

The new agreement follows our initiated indication expansion program in CIPN caused by taxanes, where preclinical studies are already ongoing to guide further development in 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 deepen our collaboration with our partner Solasia.

Continued significant scientific interest for our clinical projects

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 this as yet another confirmation that Aladote results generate great interest potentially to meet the unmet medical need for the treatment of paracetamol poisoning beyond current standard of care.

Listing on the main market

In parallel with our groundbreaking work with our clinical projects, we are very pleased with the completion of the process to be listed on Nasdaq Stockholm’s main list. On October 16, we announced that Nasdaq Stockholm’s Listing Committee has approved that the company’s shares are admitted to trading subject to customary conditions. The October 31 is set as the first day of trading. 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.

Eventful period ahead

We have a very interesting and exciting period ahead of us, and an important milestone is of course the completion of the recruitment to the POLAR studies. During the fourth quarter of 2019, we are also having regulatory interactions with the FDA and the EMA, in relation to the development program of Aladote to optimize the path to a possible market approval. Preclinical taxanes studies are progressing as planned, and we are looking forward to the results from them early next year. In parallel, we are also planning a Scientific advisory board meeting in December to further discuss clinical development of PledOx in taxanes. These are important steps and I look forward to updating you on our continued progress.

Nicklas Westerholm, CEO
PledPharma AB, Stockholm