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Promore Pharma AB (publ) Interim report January – June 2020

April to June

  • Net sales amounted to MSEK 0 (0.7).
  • The operating loss for the period was 6.7 (-7.4) MSEK
  • Net loss was 6.5 (-7.3) MSEK, corresponding to earnings per share of SEK -0.18 (-0.36)
  • Cash flow from operating activities amounted to -6.0 (-6.9) MSEK
  • Cash and cash equivalents amounted to 39.9 (19.7) MSEK

January to June

  • Net sales amounted to MSEK 0 (1.2).
  • The operating loss for the period was 14.0 (-12.9) MSEK
  • Net loss was 13.6 (-12.8) MSEK, corresponding to earnings per share of SEK -0.37 (-0.63)
  • Cash flow from operating activities amounted to 21.0 (11.3) MSEK

Significant events during the period January – June

  • The targeted number of 120 patients completing treatment in the HEAL LL-37 Phase IIb clinical trial with ropocamptide was reached
  • The company CFO leaves in 2020
  • A performance-based stock savings program approved by the AGM
  • Erik Magnusson appointed CFO

Significant events after the reporting period

  • Patent granted for ropocamptide in the US

CEO statement

The first half of 2020 has been filled with activities that, fortunately, have not been significantly affected by the ongoing COVID-19 pandemic. In contrast to many companies in our sector that have experienced disruptions in their clinical programs, we have had the privilege of being able to follow our business plan.

We have made our most important progress in our project with ropocamptide, involving a new treatment of venous leg ulcers, the most common type of chronic leg wounds. It is very gratifying to note that the recruitment- and treatment period for the subjects in our clinical trial (HEAL LL-37) regarding ropocamptide is now completed, despite the ongoing COVID-19 pandemic and earlier this year, we achieved the goal to to have approximately 120 patients complete the treatment period in accordance with the study protocol. All data in our study database is now controlled and verified; we were therefore able to declare clean file in July, which means that we have now started processing the data. This is very extensive analysis work that will allow us to compare tolerability, safety and efficacy between different treatment groups. We expect to be able to present final data from the study during the fourth quarter of this year. So far, we note that the technical quality of the project, in terms of compliance with the study protocol, is very high.

If the analysis of data from the ongoing clinical study shows a clear treatment effect of ropocamptide versus placebo, we assess that we should have very good opportunities to create great value for our shareholders, as we address a great medical need, and a huge market. Estimates show that healthcare costs for treating a single chronic wound often exceed USD10,000. In the United States alone, the aggregated healthcare costs for patients with chronic wounds are estimated to exceed USD 25 billion annually. In Scandinavia, chronic wounds are estimated to account for up to four percent of the total societal cost of healthcare. Our goal is to develop the ropocamptide project towards a treatment that can contribute to both improved treatment results and future economic benefits for the healthcare system.

In the ensereptide project, the planning work continues, to allow us to start enrolment into our Phase III study, PHSU03, as soon as the financing of the entire study is secured. Ensereptide is a therapeutic peptide that aims to prevent the occurrence of undesirable post-surgical adhesions, primarily in conjunction with repair of damaged tendons in the hand.

We announced earlier this year that we have not been affected by any significant direct effects of the ongoing COVID-19 pandemic and that perception remains. It is still difficult to assess the consequences of the crisis, but one thing experts in various functions seem to agree on is that it will take a long time to reach normalization. This creates a large number of uncertainties in almost all sectors of society. For us as a company, this can mean, for example, delayed interactions with authorities, limitations in our contacts with healthcare institutions, capacity limitations of subcontractors, changed priorities at other companies with potential interest in concluding license agreements and strategic alliances, and uncertainties in the capital markets that may have implications for future capital raising. Our overall plans have not been significantly affected, but we will of course continuously work to understand how our situation may be affected. I also want to stress, that we are constantly reviewing how we can reduce our costs to enable us to extend the runway for our current cash, in addition to what we originally planned for. In this way, we hope to create increased flexibility for future financing.

I would also like to take this opportunity to welcome our new CFO, Erik Magnusson, who is joining the company this month. Erik has extensive experience from the capital markets and the life science sector and I am very much looking forward to
our future collaboration. I would also like to take this opportunity to direct my heartfelt thanks to Jenni Björnulfson who is leaving us, for all her important contributions in recent years in our management team. I want to wish her the best of luck in her upcoming new professional endeavors.

With excitement, I am now I looking forward to the results of our clinical trial HEAL LL-37, which we hope to be able to
publish at the end of the year. My coworkers and I are convinced that our future outcome will benefit both shareholders and patients.

The full interim report is available at