Year-end report 2020
October to December
- Net sales amounted to MSEK 0 (1.5)
- The operating loss for the period was MSEK -6.9 (-9.4)
- Net loss was MSEK -7.8 (-9.4), corresponding to earnings per share of SEK -0.21 (-0.38)
- Cash flow from operating activities amounted to MSEK -7.6 (-0.3)
- Cash and cash equivalents amounted to MSEK 24.2 (60.5)
January to December
- Net sales amounted to MSEK 0 (3.9)
- The operating loss for the period was MSEK -29.1 (-29.1)
- Net loss was MSEK -29.4 (-28.9), corresponding to earnings per share of SEK -0.81 (-1.35)
- Cash flow from operating activities amounted to MSEK -37.5 (-18.5)
Significant events during 2020
- The targeted number of 120 patients completing treatment in the HEAL LL-37 Phase IIb clinical trial with ropocamptide was reached, with a total of 148 treated patients.
- A long-term incentive program approved by the AGM.
- Erik Magnusson appointed CFO.
- Patent granted for ropocamptide in the US.
- In late November, the company presented data from the finalized HEAL LL-37 study. The main conclusion is that treatment with ropocamptide in the dose of 0.5 mg / ml provides a significantly improved cure in the difficult-to-treat patient group with large venous leg ulcers.
Events after the reporting period
- No significant events after the reporting period.
”Ensereptide is a versatile drug molecule that could offer a revolutionary treatment value in several fibrotic diseases. In addition to the potential of reducing adhesions after tendon repair surgery in the hand, as proven in previous clinical trials, ensereptide could also result in a product that prevents the occurrence of adverse scarring of the skin after surgical procedures or traumatic injuries.”
Comments from the CEO
Promore Pharma's vision is reflected in a long-term commitment to research and development that can lead to drugs that can significantly improve the lives of patients with scarring and difficult-to-treat wounds. These conditions often result in pain, suppressed mobility, reduced quality of life and social stigma. Our ambition is to evolve our pharmaceutical projects to opportunities that can improve the quality of life for patients who currently lack effective treatments, and for these potential future products to offer an important medical difference for patients in this market segment.
The company's two product candidates have a strong safety profile that has been validated in several clinical trials, which means a significantly lower development risk compared with many other projects in other therapeutic areas that are in the same development stage. The lower risk also means that we can carry out clinical trials at a lower cost than is the case in many other therapeutic areas.
In November 2020, we were pleased to conclude that our clinical trial regarding ropocamptide for the treatment of venous leg ulcers (HEAL LL-37) could be completed, with a positive and very appealing result. Data from the clinical trial showed that ropocamptide can significantly and statistically significantly improve the healing of large venous leg ulcers, i.e. wounds that are 10 cm2 or larger. We thus possess a product candidate that appears to have a high medical efficiency, without causing limiting adverse effects in the selected dose range, in a patient segment where there are currently no effective drugs. The estimated cost of treating an average venous leg ulcer in Western Europe and the US is about SEK 100,000. For the approximately 1 million patients with large venous leg ulcers in the traditional pharmaceutical markets, this cost can be several-fold higher. The development of ropocamptide could thus result in a product that can offer significantly improved treatment results for the patient and contribute to economic benefits for the healthcare system in the future.
In 2020, we also took important steps in our second project, ensereptide (PXL01). Our team has worked hard to enhance the manufacturing process of the ensereptide product, which is the activity that is on the so-called critical timeline for future clinical trials. The work has included evaluation of several production alternatives.
Ensereptide is a versatile drug molecule that could offer a revolutionary treatment value in several fibrotic diseases. In addition to the potential of reducing adhesions after tendon repair surgery in the hand, as proven in previous clinical trials, ensereptide could also result in a product that prevents the occurrence of adverse scarring of the skin after surgical procedures or traumatic injuries.
We thus believe that we have a very good opportunity to create considerable value by addressing several commercially significant market segments with ropocamptide and ensereptide.
While the COVID-19 pandemic is likely to have long-term effects on the healthcare system, which, among other things, may have an impact on the execution of clinical trials, at Promore Pharma, we have the privilege of having a program platform which provides several development options. With this background, the management and the board are currently performing a comprehensive evaluation of strategic alternatives within our main projects, in order to create a robust, value-enhancing and cost-effective strategy, and financial plan, that is aligned with our current position. The aim is to announce this revised strategy during March/April 2021.
Last but not least, I would like to express my great gratitude for all support and hard work that contributed to making 2020 a year of important progress for Promore Pharma, despite the current global situation. By continuing the development of these assets towards market registration, and at the same time, opportunistically, seeking new strategic alliances that broaden the use of our assets, we are convinced that we can deliver value to our shareholders.
Stockholm, 23 February 2021,
President & CEO
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