January-March
- Net sales amounted to MSEK 0 (0).
- Net loss was MSEK -8.4 (-7.1), corresponding to earnings per share of SEK -0.14 (-0.21).
- Cash flow after financing activities amounted to MSEK -8.9 (-5.7).
- Cash amounted to MSEK 36.4 (18.6).
Significant events during January – March
- 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.
- The recruitment target for the study achieved according to plan in March.
Events after the reporting period
- No significant events reported after the period.
”In February we started the recruitment to our clinical trial PHSU05 for the
prevention of skin scars, and we reached the target in March according to plan”
Jonas Ekblom, President and CEO of Promore Pharma
Statement of the CEO
The first quarter has been characterized by intensive work with our clinical trial program; PHSU05, a Phase II study with PXL01 for prevention of skin scarring. In February, we began enrolment in this clinical trial and we reached recruitment goal in March.
Another important focus area has been – and continues to be – the work of developing a single-component product for the drug candidate ropocamptide. This is a work that includes extensive stability analyses, where the goal is to be able to conclude if a single-component product has adequate properties such as appropriate storage stability and viscosity, as well as assessing if a robust and scalable manufacturing process can be established.
Promore Pharma’s project portfolio consists of therapeutic peptides, each with a significant medical value in a large number of different medical indications for the bioactive wound care market. We work to position the company as a pioneer in the treatment of wounds as well as prevention of scars and adhesions, and we believe that the aggregate addressable market for Promore Pharma’s product candidates amounts to more than USD 15 billion annually when including opportunities for indication broadening, such as different forms of tissue scarring and diabetic foot ulcers.
The clinical trial conducted within the ensereptide program, PHSU05, is a double-blind, randomized Phase II pilot study with the goal of being able to evaluate ensereptide regarding (i) local tolerance, (ii) the application process for the experimental drug, as well as (iii) preliminary efficacy regarding prevention of scarring in artificially induced wounds in healthy volunteers. The study is conducted at Uppsala University Hospital, and currently includes 24 subjects. Treatment with ensereptide or placebo is conducted at one single occasion, in connection with the surgical procedure, and the subjects are then followed for about 13 weeks. At the last clinic visit, biopsies will be collected, which will then be evaluated by advanced histological methods in the fall of 2022. A final study report with results from the trial is expected in winter 2022/2023.
Within the ropocamptide project, we continue the technological development. In previous clinical studies, we have used an experimental product based on two components that need to be mixed prior to each administration event. In order to achieve a commercially successful product, we believe it is important to have a user-friendly product that does not require preparation. Our goal is to complete this work during the third quarter of 2022. In parallel with this development, we do what we can to prepare for a Phase III test of ropocamptide in the EU.
In an analysis of the outside world and of the company’s competitive situation, we conclude that the interest in bioactive wound care is continuously increasing. The development of new wound care products takes place extremely interdisciplinary, and new products are developed in several different categories – such as prescription drugs, medical technology products and so-called over the counter (OTC) products. The number of patents that are submitted annually within the wound care area has constantly increased over the past ten years.
We are constantly getting proposals for strategic collaborations and requests for further applications of our products. I interpret this as a sign of a significant interest in Promore Pharma’s products and the importance of drug development for conditions that today lack effective treatments. Our board and management are determined to build Promore Pharma with smart partnerships towards becoming a leading biotechnology company in bioactive wound care. We are convinced that this will result in a significant value enhancement in the medium term.
Finally, I would like to thank our employees, the board and shareholders for this first quarter in 2022 and for the confidence you have shown our company.
Solna, May 17, 2022
Jonas Ekblom
President& CEO