Half-Year report January-June 2019

April-June

· Quarterly net sales MSEK 4.4 (9.7)

· Quarterly results MSEK -29.4 (-28.2)

· Cash and cash equivalents MSEK 319.5 (267.1)

· Cash flow from operating activities MSEK 61.5 (-27.3)

· Result per share SEK -0.6 (-0.6)

· PledPharma completed a directed new share Issue of 4,866,665 shares, raising proceeds of SEK 91 million at a subscription price of SEK 18.7 per share, corresponding to zero percent discount to May 21 closing price

PledOx®

· Patient recruitment to the global phase III studies POLAR-A and POLAR-M is continuing. The ambition is to deliver top-line results before year-end 2020

· PledPharma presented the global Phase III program of PledOx® at the international cancer conference American Society of Clinical Oncology (ASCO)

· Pre-clinical studies to expand PledOx® indication to Chemotherapy Induced Peripheral Neuropathies (CIPN) associated with taxanes have been initiated

Aladote®

· PledPharma’s drug candidate Aladote® and its proof of principle study (POP study) results were recognized as one of the highlights at one of the world’s largest liver conferences, European Association of the Study of the Liver International Liver Congress (EASL ILC)

Significant events after the reporting period

· Regulatory interactions with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the development program are planned for the fourth quarter 2019

· The Aladote study results was ® published in Lancet EBioMedicine

Comments from the CEO

COMPLETED RIGHTS ISSUE BENEFITS OUR DEVELOPMENT PROGRAMS

In the second quarter of 2019, a number of important milestones were passed, both for the company and our two clinical projects.

The Phase III program for PledOx® is well underway

The recruitment of our global Phase III POLAR studies of PledOx is proceeding, and it is our objective to deliver top line results before year end 2020 and after marketing authorization approval introduce the first drug to prevent CIPN caused by chemotherapy. The recruitment of patients in Europe, Asia and the US is well underway. In total 101 clinical sites in Belgium, France, Italy, England, Germany, Spain, Czech Republic, Hong Kong, Taiwan, Korea, US and Japan actively participates in the POLAR program. Earlier in the year, our Asian partner Solasia Pharma announced that the first patient had been included in Japan. As a result, we received our first milestone payment of MSEK 49 from Solasia.

Strengthened financial position benefits our development programs

The company’s financial position was strengthened with ca MSEK 91, gross, during the quarter. We have a clear strategic plan how to use the proceeds from the issue. Firstly, we will accommodate the clinical development of our drug candidate Aladote given the positive results from the first clinical study and the newly granted orphan drug designation (ODD) in the US. Secondly, the preclinical indication expansion program of PledOx® in Chemotherapy Induced Peripheral Neuropathy (CIPN) caused by taxanes is proceeding. Thirdly, activities required for a market authorization application of PledOx in oxaliplatin-induced CIPN.

Indication expansion for PledOx® ongoing with taxanes

To create further value with PledOx, we have initiated an indication expansion program in CIPN caused by taxanes with a high medical need similar to that of CIPN triggered by oxaliplatin. Taxanes have a significant use in clinical practice for example in the treatment of breast and ovarian cancer. Our ambition is to create an additional opportunity to offer cancer patients a treatment that prevents CIPN side effects and improves the quality of life. These preclinical studies are underway, and we will update you about this exciting opportunity in future announcements.

Significant scientific interest validates the possibilities for our clinical projects

In April, the results from the proof-of-principle study (phase Ib/IIa) of Aladote were presented at the annual EASL International Liver Congress, in Vienna, Austria, which is one of the largest global scientific conferences in the field of hepatology. The study results were recognized as one of the highlights at the conference, which of course is very gratifying for us. After the period, in July, the results of our proof-of-principle with Aladote were published in the Lancet’s EBioMedicine. This publication 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.

The global phase III program POLAR with PledOx was presented at a poster session during the annual ASCO conference in Chicago in June. The presentation of the study of PledOx at the most prominent oncology conference is a validation of the interest in its potential.

Listing on the main market

The process to list our share on Nasdaq Stockholm’s main market is progressing, and we aim to have it completed in the fourth quarter. Our desire with this move is to create further interest from a broader investor base, which will also reflect the maturity of our business.

Eventful period ahead

The most important milestone is of course the completion of the recruitment to the POLAR studies.

During the fourth quarter of 2019, we are having regulatory interactions with the US FDA and the EMA, in relation to the development program of Aladote to optimize the path to a possible market approval. These are important steps towards meeting the medical need of those suffering from paracetamol poisoning and is one of many project activities that we will achieve in the near future.

With the events and activities mentioned above, combined with a globally robust IP portfolio for PledOx and Aladote and our strong organization, I am looking forward to an eventful and exciting period ahead of us.

Nicklas Westerholm, CEO
PledPharma AB, Stockholm