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Interim report January – June 2021

April to June

  • Net sales amounted to MSEK 0 (0)
  • Net loss was MSEK -7.9 (-6.5), corresponding to earnings per share of SEK -0.22 (-0.18)
  • Cash flow from operating activities amounted to MSEK -54.1 (-6.0)
  • Cash amounted to MSEK 13.1 (39.9). The funds from the new share issue was added to the company after the end of the period

January to June

  • Net sales amounted to MSEK 0 (0)
  • Net loss was MSEK -15.0 (-13.6), corresponding to earnings per share of SEK -0.41 (-0.37)
  • Cash flow from operating activities amounted to MSEK -60.9 (-21.0)

Significant events during January – June

  • In January, the company entered an agreement with Erik Penser Bank AB regarding services as Certified Adviser. Erik Penser bank took over as Certified Adviser on 25 January 2021.
  • In March, Promore Pharma decided on an adjustment of the company’s strategy. The development of the drug candidate ensereptide (PXL01) will be focused on scar prevention in connection with surgery.
  • In March, warrants corresponding to a dilution of 3.0% of the number of outstanding shares were deregistered.
  • In April, an important milestone was achieved when the company signed an agreement with the Italian company, Fidia Farmaceutici S.p.A,. for the production of GMP certified hyaluronic acid.
  • In May, a fully guaranteed new share issue of approximately SEK 48 million was announced for the purpose of implementing the revised strategy of the company.
  • In May, it was also announced that the company received a granted patent in the United States for the use of the peptide ensereptide (PXL01) for prevention of skin scarring.
  • In June, the company announced that the new issue had been concluded, yielding a net SEK 45.0 million.
  • Hans-Peter Ostler was elected new member of the board.

Events after the reporting period

  • No significant events after the reporting period.

”We are very pleased with the response that we received in connection with the capital raise in the spring. Both existing and new capital-strong shareholders have shown confidence in both the company and the re-prioritization of the ensereptide program that has been directed towards the scarring market.”

Jonas Ekblom, President and CEO of Promore Pharma

Comments from the CEO

During the second quarter of the year, four essential milestones were achieved: (i) the completion of a capital raise which brought about SEK 45 million after transaction costs, (ii) the approval of a patent in the United States regarding ensereptide for prevention of scarring, (iii) signing a substantial manufacturing agreement with Fidia Farmaceutici S.p.A, as well as (iv) the initiation of the manufacturing of investigational product for the company’s upcoming clinical trial of ensereptide for prevention of scars on the skin.

We are very pleased with the response that we received in connection with the capital raise in the spring. Both existing and new capital-strong shareholders have shown confidence in both the company and the re-prioritization of the ensereptide program that has been directed towards the scarring market. The capital increase enables several value-generating steps in Promore Pharma, and we look forward to initiating studies and further development efforts during the current and next year.

Within the ensereptide program, the company has now redirected the focus from hand surgery to develop a product to prevent skin scarring. Through this change, we will be able to address a significantly much larger market. The global market for products intended to prevent or treat scars on the skin is estimated at more than USD 25 billion. Today, there are no pharmaceutical products for prevention of scarring. The work has begun to manufacture an investigational product for the planned Phase II study, PHSU05, concerning the prevention of scarring on the skin. Our goal is to be able to start recruitment into this clinical trial during the first quarter of 2022. We are very satisfied that we could sign an agreement with Fidia Farmaceutici in April for the production of GMP-certified hyaluronic acid which constitutes an important raw material in the ensereptide product.

Within our project against chronic wounds (ropocamptide, LL-37), we have started compiling a scientific publication of the clinical study that was completed in Q4 2020 which showed statistically significant improvement in the healing of wounds greater than 10 cm2. In addition, we are carrying out a comprehensive third-party review of the project to support the development strategy in the project. We have also begun some technical development aimed at product improvement. Whether the company performs future clinical studies on its own or with strategic partners, the development of a more user-friendly product will be important both in the clinical study environment and when the product reaches the market.
In parallel with this work, we also search for the possibility of strategic partnerships and alliances. There are several reasons why Promore Pharma sees a collaboration with a fully integrated company as an advantageous path forward to maximize the potential of the ropocamptide program, among other things for the execution of final clinical studies and also because the future commercialization of ropocamptide will require financial resources, knowledge and human resources that only larger pharmaceutical companies possess.

Promore Pharma has so far only been marginally affected by COVID-19. The HEAL LL-37 trial, that was completed in 2020 could be performed largely as planned, and since we are limiting the focus of ensereptide to scarring in skin, the planned Phase IIa study on that indication can be carried out with only marginal adjustments.

At the Annual General Meeting on 27 May 2021, Hans-Peter Ostler was elected as a new member of the company’s board. Hans-Peter is, among other things, chairman of the board of Oblique Therapeutics and board member of Alligator Biosciences and Inorbit TX. On behalf of our company and network, I wish to extend a welcome to Hans-Peter, as well as a number of new shareholders who participated in our new share issue in June, to Promore Pharma and the exciting journey we have ahead of us.

Solna, August 24, 2021
Jonas Ekblom
President & CEO