January – March
- Net sales amounted to MSEK 0 (0)
- The operating loss for the period was MSEK -7.1 (-7.3)
- Net loss was MSEK -7.1 (-7.0), corresponding to earnings per share of SEK -0.19 (-0.19)
- Cash flow from operating activities amounted to MSEK -6.8 (-15.0)
- Cash and cash equivalents amounted to MSEK 18.6 (45.9)
Significant events during the period January – March
- In January, the company signed an agreement with Erik Penser Bank regarding Certified Adviser services.
- In March, Promore Pharma decided upon a strategy adjustment. The development of ensereptide (PXL01) will be focused on post-surgery skin scar prevention. The strategy change will, among other things, lower the capital requirement in the coming years.
- In March, the company announced that an amount of 72 755 warrants corresponding to a dilution of 3.0% have been deregistered, relating to programs 3-7 issued to Technomark Group USA LLC and Kentron Biotechnology Pvt Ltd.
Events after the reporting period
- In April, an important milestone was reached as the company signed an agreement with Italian Fidia Farmaceutici S.p.A regarding the production of hyaluronic acid, one of the components for our drug candidate ensereptide.
- In May, the company announced a fully secured rights issue to the amount of gross MSEK 48 in order to finance the revised strategy.
”Through this approach, we will be able to address a very large market; the global market for products for preventing or treating scars on the skin is estimated at close to USD 25 billion. Today, there are no pharmaceutical products for the prevention of scarring.”
Comments from the CEO
The year 2021 has started in a very positive way for Promore Pharma. During the first quarter, we made an adjustment of our strategic direction and we laid the foundations for a rights issue that intends to finance the new business plan over the next two years.
Promore Pharma’s management and board have analyzed and reconsidered the conditions for the company’s two projects ensereptide and ropocamptide, which has led to some modifications to our operating plan.
Within the ensereptide project, the company therefore redirects the focus from hand surgery to developing a product for the prevention of scarring on the skin. This means that instead of conducting the comprehensive phase III study of ensereptide for tendon ruptures, the company intends to conduct a smaller phase II trial for technical concept validation within this new indication. Through this approach, we will be able to address a very large market; the global market for products for preventing or treating scars on the skin is estimated at close to USD 25 billion. Today, there are no pharmaceutical products for the prevention of scarring. Already during the first months of the year, we have begun the planning to enable the phase II study, PHSU05, concerning the prevention of scarring on the skin. Our goal is to be able to begin recruitment for this clinical trial during the first quarter of 2022. During the current year, we will devote ourselves to preparatory work such as manufacturing experimental drugs, and to submit clinical trial applications.
We are very satisfied that we were able to sign an agreement with Fidia Farmaceutici S.p.A. (“Fidia”) in April for the production of hyaluronic acid. Fidia is a world-leading manufacturer of pharmaceutical hyaluronic acid, and the agreement will enable Promore Pharma to acquire raw materials of optimal quality, and at a scalable volume that is suitable for both the company’s current and future demands. Fidia has its manufacturing facilities in Italy.
Within our chronic wound project (ropocamptide, LL-37), we have during the first quarter of the year begun work on preparing a scientific publication of the clinical study and conducting a comprehensive third-party review of the project in order to best plan for the further development strategy of the project. We also intend to conduct certain technical development aimed at product improvement; regardless of whether the company conducts future clinical studies under its own sponsorship, or together with strategic partners, the development of a more user-friendly product will be important both in a clinical study environment and once the product reaches the market. In parallel with this work, the company will also opportunistically seek strategic partnerships and alliances.
The Board of Directors of the company decided on 7 May 2021, on the implementation of a rights issue with the goal of raising approximately SEK 48 million before transaction costs. The new share issue, which will be approved at an extraordinary general meeting to be held on May 27, 2021, will be fully secured through subscription commitments and issue guarantees. This capital increase will provide the funds that Promore Pharma needs to execute the new strategy and thus enable concentrated and distinct development steps for ensereptide and ropocamptide with the potential to generate significant shareholder value. We are also extremely happy to be able to present a financing solution where the total transaction costs are considered low. Our financial advisor in this process is Erik Penser Bank.
For a long series of years, we have step by step driven our projects forward. For each step we have taken, our enthusiasm and confidence in the projects has grown. We also start this year with a conviction that in 2021 we will be able to continue to deliver results that strengthen our two projects, and thus increase the value of the company’s technology base. We look forward to an exciting time in Promore Pharma’s development.
Solna 27 May 2021
President & CEO