Promore Pharma AB (publ) Interim report January - September 2018

July to September

• Net sales amounted to 1.0 (0) MSEK .
• The operating loss for the period was 7.4 (-4.4) MSEK
• Net loss was 7.6 (-4.8) MSEK, corresponding to a loss per share of SEK-0.38 (-0.24)
• Cash flow from operating activities amounted to -6.7 (-15.2) MSEK
• Cash and cash equivalents amounted to 39.5 (72.6) MSEK

January to September

• Net sales amounted to 1.1 (0) MSEK .
• The operating loss for the period was 26.1 MSEK (0.9) MSEK
• Net loss was 25.3 (2.5) MSEK, corresponding to a loss per share of SEK -1.25 (0.16)
• Cash flow from operating activities amounted to -23.8 (-7.2) MSEK

Significant events during the period January - September

• 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

Significant events after the end of the reporting period

• 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

CEO statement

The year has been intense. The third quarter was characterized by continued preparatory work for our two clinical development programs: HEAL LL-37, a Phase II study of LL-37 for the treatment of venous leg ulcers, and PHSU03, a Phase III study with PXL01 for the prevention of adhesions after tendon - and nerve repair in the hand.

We have been working hard in our LL-37 project in 2018 and in July, this resulted in an approval by the Swedish Medical Products Agency to start HEAL LL-37. In August, we received the corresponding approval from the Polish Authorities. In September we hosted an investigator meeting in Warsaw and I am very pleased that we have now been able to start recruitment in this international multi-center study and that the trial is progressing according to plan.

Within the PXL01 program, we have also made significant progress. I am very pleased with the approval we recently received from the Drug Controller General of India (DCGI) for our Phase III clinical trial in India. We see this as a valuable confirmation of our regulatory approach in this multinational project. We have in recent months worked to solve a number of technical problems within Manufacturing of Investigational Medicinal Product for the clinical Phase III study with PXL01. Clinical development projects of this type are complex and are always associated with different uncertainties that may affect the timeline. To reduce the risk of delays in the project we have initiated contacts with several suppliers of medicinal products. Our goal is to be able to file national clinical trial applications in Europe as soon as the manufacturing issues are resolved. 

Within the PXL01 program, we reached a milestone when we met with the US Food and Drug Administration (FDA) in the fall to discuss manufacturing, quality, nonclinical and clinical documentation for PXL01 and the design of a potential Phase III study. The FDA confirmed that completed manufacturing documentation and plans, as well as nonclinical safety and local tolerability studies, provide a good basis for a proposed clinical trial in the United States. The FDA concluded that the next clinical trial in the United States, where design is still being discussed, in combination with the results of the Clinical Phase III trial in Europe (PHSU03) could be feasible as a basis for a U.S. Market Application. We are very pleased with the outcome of the meeting with the FDA. We have now confirmed that we have a satisfactory material for the continued development of PXL01 and we have received valuable recommendations for our regulatory path in the United States.

 In the company we are now working with the planning for the coming year. Overall, our progress within the company's development program brings big hope for an exciting time ahead of us. My colleagues and I are filled with a conviction that our future final results will benefit all our stakeholders, shareholders and not least the patients.

Solna 23 November 2018

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 

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 and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 16:00 CET on 23 November 2018.