April to June
- Net sales amounted to MSEK 0 (0)
- Net loss was MSEK -6.1 (-7.9), corresponding to earnings per share of SEK -0.10 (-0.22)
- Cash flow after financing activities amounted to MSEK -6.8 (-5.5)
- Cash amounted to MSEK 29.6 (13.1), compared to MSEK 45.3 on 31 December 2021
January to June
- Net sales amounted to MSEK 0 (0)
- Net loss was MSEK -14.5 (-15.0), corresponding to earnings per share of SEK -0.24 (-0.41)
- Cash flow after financing activities amounted to MSEK -15.7 (-11.2)
Significant events during January – June
- In January 2022, warrants corresponding to a dilution of 0.2% of the number of outstanding shares were deregistered.
- In February 2022, the first trial person was enrolled in PHSU05 (ensereptide).
- The recruitment target for the study was achieved according to plan in March.
- In June 2022, the last clinic visit in PHSU05 occurred (ensereptide).
- At the AGM in May, Marianne Dicander Alexandersson was elected new chairman of the board. Also, Candice Jung was elected new member of the board.
Events after the reporting period
- In August 2022, the company received a granted patent in the European Union for the use of the candidate drug ropocamptide (LL-37) for the treatment of chronic wounds.
”I am pleased to say that Promore Pharma, despite the current situation in the world, so far, has been able to follow the operating plan”
Jonas Ekblom, President and CEO of Promore Pharma
Statement of the CEO
The first half of 2022 has been intense and successful. I am pleased to say that Promore Pharma, despite the current situation in the world, so far, has been able to follow the operating plan, and thereby conduct the development at the scheduled rate.
We have made important progress in our project with ensereptide which is aimed as a new treatment to prevent skin scarring. It is very satisfactory to note that the clinical part (recruitment, treatment and follow-up) in our clinical trial PHSU05 has been successfully completed according to plan during the first six months of the year. We have achieved the goal of finalizing the treatment and follow-up of 24 patients in accordance with the clinical study protocol. The project has four fundamental components: (i) a single treatment event with ensereptide or placebo, (ii) a three-month follow-up period, (iii) an extensive histopathological analysis of biopsies collected, and finally, (iv) an analysis phase of the study when the data is quality assured and analyzed in detail by the reviewers defined in the study plan. We expect to be able to unblind the study results and present final data from the study in the first quarter of 2023. At present, work on the histopathological analysis is where we put our largest attention.
If the analysis of data from the ongoing clinical study demonstrates a clearcut treatment effect of ensereptide, we make the assessment that we have very good opportunities to create great values as we address a great medical need, and a gigantic marketplace.
We have also made important progress in our project with ropocamptide which relates to a new treatment of venous leg ulcers, the most common type of chronic wounds. The technological development is currently aimed at creating an improved dosage form that is more user-friendly. Although this work will continue for the rest of 2022, we can already say that a number of significant risks have been removed. We have created a preliminary manufacturing process that seems to be robust, cost-effective and scalable. We are now working with external service providers to validate that this manufacturing process results in an end-product that meets all our specifications.
We also continue the planning work to enable a Phase III trial with ropocamptide in the EU. The company has not yet made any decisions regarding timing of study initiation or financing.
At present, the company has not suffered any extensive consequences of the ongoing conflict in Ukraine. The perceptions of the crisis vary, but one thing experts in various functions seem to agree upon; there are a large number of uncertainties in nearly all sectors of society. For us as a company, it may, for example, mean capacity restrictions in the availability of certain raw materials, changed priorities at other companies that affect the interest in entering license agreements and strategic alliances, as well as uncertainties in the capital markets that may have implications for future capital raises. Our overall plans have so far not been significantly affected, but naturally, we are constantly working to assess how this may affect our situation. We have a stable cash position, and I believe that we have the resources to conduct our work according to plan, at least for a year ahead.
All in all, our progress within the company’s research programs gives me great hope for an exciting time ahead of us, awaiting results from our clinical trial of ensereptide, PHSU05, where we expect to have results around the turn of the year. My colleagues and I are hopeful that our future end results will benefit all our stakeholders, not least the patients.
Solna, August 30, 2022