Promore Pharma AB (publ) Year-end report 2018

October to December

• Net sales amounted to 1.4 (0.6) MSEK.
• The operating loss for the period was 6.5 (-10.4) MSEK
• Net loss was 7.2 (-10.9) MSEK, corresponding to a loss per share of SEK 0.35 (-0.54)
• Cash flow from operating activities amounted to -8.7 (0.2) MSEK
• Cash and cash equivalents amounted to 30.9 (63.0) MSEK

January to December

• Net sales amounted to 2.4 (0.6) MSEK.
• The operating loss for the period was 32.7 MSEK (-9.6) MSEK
• Net loss was 32.5 (-8.4) MSEK, corresponding to a loss per share of SEK -1.61 (-0.51)
• Cash flow from operating activities amounted to -32.5 (-7.0) MSEK

Significant events during the period January - December

• Cellastra Inc’s option to receive a license to commercialize PXL01 in North America expired.
• Promore Pharma regained PXL01 manufacturing rights
• Out-licensing agreement for PXL01 signed with PharmaResearch Products Ltd (“PRP”) meaning PRP will finance the development of PXL01 for use to prevent fibrosis after spinal surgery.
• Approval to start the LL-37 Phase IIb study (HEAL) on patients with venous leg ulcers from the Medical Product Agency in Sweden
• Approval to start the LL-37 Phase IIb study (HEAL) on patients with venous leg ulcers in Poland
• First patient recruited in HEAL LL-37 in Poland
• Successful meeting with the FDA regarding PXL01
• Approval from Drug Controller General in India to start Phase III study with PXL01

Significant events after the end of the reporting period

• Phase III trial with PXL01 modified and the number of clinics in the study expanded

CEO statement

The past year, 2018, was in many ways a decisive year for Promore Pharma. We achieved several scientific and operational milestones in our main projects. The fiscal year was characterized by continued preparatory work within our two clinical development programs - HEAL LL-37, which is a phase IIb study with our drug candidate LL-37 for the treatment of venous leg ulcers and PHSU03, a phase III study with our drug candidate PXL01 for prevention of adhesions after tendon- and nerve-repair surgeries. These two indication areas are currently without pharmaceutical products.

We are very pleased with the development of our LL-37 project, where we after extensive work received study approval first in Sweden and then in Poland during the summer. In October, we were able to announce that we recruited our first patient and currently the study is in a phase of active patient recruitment that proceeds according to plan. The goal is to include 120 patients in this multi-center study, which is carried out in Sweden and Poland.

We are also pleased that Promore Pharma received a so-called Notice of Allowance in the United States for a patent for the application of specific LL-37 doses medically relevant for the treatment of chronic wounds. This gives us an extended patent protection in this project.

In our clinical Phase III trial of PXL01, (PHSU03), the preparatory work continued in 2018. We have had problems with one individual supplier that has not succeeded in renewing all of the manufacturing permits required and consequently, they have not been able to provide an important component in the manufacturing chain at the specified time. This is one of several reasons why we wish to improve our long-term production capacity as well as process quality and also reducing the risks of dependency on individual suppliers in the manufacturing process. This in turn meant that we in 2018 started work on changing the manufacturing chain.

In order to minimize the likelihood of time losses on the way to market approval, the company plans to increase the number of clinics in the PHSU03 study by also including a number of hospitals in Italy, thereby minimizing the overall delay by accelerating the recruitment of patients. We have received our clinical trial application approval by the Indian Medicines Agency (Drug Controller General of India), and our goal is to solve the challenges we have left with the manufacturing chain and then to submit national clinical trial applications in Europe.

We can see several medical applications of PXL01 and in 2018 we took some important initiatives to actualize the potential of our drug candidate. In May, we entered into an out-licensing agreement with the South Korean company PharmaResearch Products Ltd. about developing PXL01 also in the field of spinal surgery. A significant proportion of surgical procedures for treating degenerative disc disorder fail because of fibrosis or adhesions. Every year, approximately two million back-surgery procedures are performed in degenerative disc disorder on the traditional drug markets, which will be the sub-segment that our partner focuses on. In addition, we plan to evaluate the applicability of using PXL01 to prevent dermal scarring, through a small controlled clinical trial (PHSU05) which we plan to start in parallel with PHSU03.  

Within the PXL01 program, we also reached another significant milestone as we in the autumn had an important meeting with the US Food and Drug Administration (FDA). In this meeting, the FDA confirmed that completed manufacturing documentation and plans and nonclinical safety and local tolerability studies provide a good basis for a proposed next clinical trial. This confirmatory information will be crucial for our ability to establish a corporate partnership for the American PXL01 market.

I am convinced that we are well positioned for the future. We are today strengthened in the belief that PXL01 and LL-37 are two pharmaceuticals that have great medical and commercial potential. We have a solid, exciting and value-creating strategy in place, and our therapeutic peptides have the potential to provide significant value not only to our shareholders but most importantly, for the patients.

I want to thank our co-workers for their commitment and efforts during the past year. Our vision is a world where patients with hard-healed wounds or complications of scarring can be offered effective treatment in order to live a normal life. This vision - to solve the global medical problems of scarring, adhesions and chronic wounds - inspires our work at Promore Pharma every day, both internally and in our collaborative network.

Solna 26 February 2019

Jonas Ekblom

President and CEO

For additional information, please contact

Jonas Ekblom, CEO

Phone: [+46] 736 777 540

Email: jonas.ekblom@promorepharma.com

Jenni Björnulfson, CFO

Phone: [+46] 708 55 38 05

Email: jenni.bjornulfson@promorepharma.com 

Street address: Fogdevreten 2, 171 65 Solna, Sweden

Website: www.promorepharma.com 

Corporate registration number: 556639-6809

Promore Pharma in brief:

Promore Pharma is a biopharmaceutical company specialized in the development of therapeutic peptides. The company’s aim is to develop first-in-category pharmaceuticals for indications where very few efficacious prescription pharmaceuticals are available, thus, addressing high unmet medical needs. Promore Pharma’s two projects are in late stage clinical development phase and have a very strong safety profile since they are based on innate substances that are administered locally. The leading project, PXL01, that will be used for prevention of post-surgical adhesions and scars, is being prepared for clinical phase III-studies in patients undergoing tendon repair surgery in the hand. LL-37 has initiated a clinical phase IIb study in patients with venous leg ulcers (VLU). The product candidates can also be deployed for other indications, such as preventing dermal scarring, adhesions after other surgical procedures and treatment of diabetic foot ulcers. The company is listed on Nasdaq First North.

This information is information that Promore Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 09.00 CET on 26 February 2019.

Promore Pharma’s Certified Adviser is Redeye AB.

Phone: [+46] 8 121 576 90 

E-mail: Certifiedadviser@redeye.se