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Interim report January – September 2020

July to September

  • Net sales amounted to MSEK 0 (1.3)
  • The operating loss for the period was MSEK -8.3 (-6.7)
  • Net loss was MSEK -8.1 (-6.7), corresponding to earnings per share of SEK -0.22 (-0.33)
  • Cash flow from operating activities amounted to MSEK -8.9 (-6.9)
  • Cash and cash equivalents amounted to MSEK 31.3 (13.0)

January to September

  • Net sales amounted to MSEK 0 (2.5)
  • The operating loss for the period was MSEK -22.2 (-19.6)
  • Net loss was MSEK -21.7 (-19.5), corresponding to earnings per share of SEK -0.59 (-0.96)
  • Cash flow from operating activities amounted to MSEK -29.9 (-18.2)

Significant events during the period January – September

  • The targeted number of 120 patients completing treatment in the HEAL LL-37 Phase IIb clinical trial with ropocamptide was reached
  • A long-term incentive program approved by the AGM
  • Erik Magnusson appointed CFO
  • Patent granted for ropocamptide in the US

Significant events after the reporting period

  • In November, the company published positive data from HEAL LL-37 showing that patients with larger leg ulcers treated with the lower dose of ropocamptide, reached complete healing three times more often than placebo.

We are very pleased with the outcome of our ropocamptide (LL-37) clinical trial. The results shows significantly better results for patients with larger VLU’s, the patient population most difficult to treat with today’s medical devices. When analyzing the primary endpoint, complete wound healing, more than three times more patients with large VLU’s reached complete healing compared to placebo.

Comments from the CEO

During the third quarter, we primarily worked on completing and analyzing data from our Phase IIb trial, HEAL LL-37, with ropocamptide (LL-37) for the treatment of venous leg ulcers. A very important milestone for the company was reached last week when we were able to present positive data from this clinical study. In parallel, we have continued to work on preparing the phase III study with our drug candidate ensereptide (PXL01) for the prevention of adhesions in tendon and nerve repair in the hand, even though that study is not yet fully financed.

We are very pleased with the outcome of our clinical study of ropocamptide. The trial shows a clear-cut treatment effect of ropocamptide for the patients with larger venous leg ulcers (over 10 cm2), the patient population that is most difficult to treat today. The study was conducted with 144 patients treated for three months, randomized into three groups: (i) placebo, (ii) low-dose ropocamptide (0.5 mg / ml), and (iii) high-dose ropocamptide (1.6 mg / ml). The study showed that patients with large wounds, treated with 0.5 mg / ml ropocamptide achieved 28.1% complete wound closure; that the group treated with 1.6 mg / ml ropocamptide reached 19.6%, while only 8.1% of the patients in the placebo group showed complete healing.

The main conclusion is that treatment with ropocamptide in the lower dose of 0.5 mg / ml provides a significantly improved cure in the difficult-to-treat patient group with large venous leg ulcers. When analyzing the primary endpoint, i.e. the fraction of patients that reached complete wound closure, more than three times as many patients achieved complete wound healing compared with placebo. The difference is statistically significant (p <0.05) for 0.5 mg / ml. When analyzing the proportion of patients who achieved 70% healing of their wounds, a statistically significant advantage could be demonstrated for both dose groups of ropocamptide compared to placebo. The mean reduction in wound size after end of treatment was 33.7% for patients treated with placebo, and 56.3% for patients treated with the most effective dose of ropocamptide (0.5 mg / ml). Regarding safety and tolerability, no serious side effects have been noted that can be considered related to the investigational drug. We are therefore very satisfied to be able to confirm the favorable safety profile that was also noted in the previous clinical trial of ropocamptide.

The fact that we recognize a clear effect of ropocamptide in patients with large venous leg ulcers is compelling. The company will now, in consultation with clinical experts and advisers within the business area, evaluate various strategic alternatives in order to create the greatest possible shareholder value. The next step is to compile the study results for publication in a scientific journal.

Regarding our clinical phase III trial, PHSU03, we have during the past year worked with further process optimization. To initiate this study, the company will need to bring in new financing, which will have a large impact on the timeline. We expect a lead time of approx. three quarters from secured financing to first patient treated. As a company, we have the advantage of having large and financially strong shareholders, which expands our ability to secure capital.

At Promore Pharma, we are now working on the planning for the coming operating year. Overall, our progress, not least the positive outcome of the ropocamptide trial, gives me great hope that we have an exciting time ahead of us.

In conclusion, I would like to thank everyone who has contributed to our efforts to improve the lives of people with chronic wounds and post-surgical complications; patients, doctors, nurses, partners, employees and shareholders. I really appreciate your valuable contributions and great support.

Stockholm, 24 November 2020,
Jonas Ekblom
President & CEO