October to December
- Net sales amounted to MSEK 0 (0)
- Net loss was MSEK -5.7 (-6.9), corresponding to earnings per share of SEK -0.09 (-0.21)
- Cash flow after financing activities amounted to MSEK -6.8 (-7.1)
- Cash amounted to MSEK 45.3 (24.2).
January to December
- Net sales amounted to MSEK 0 (0)
- Net loss was MSEK -26.8 (-29.4), corresponding to earnings per share of SEK -0.56 (-0.81)
- Cash flow after financing activities amounted to MSEK +21.1 (-36.3)
Significant events during January – December
- In January, the company entered into an agreement with Erik Penser Bank AB regarding services as Certified Adviser.
- In March, Promore Pharma decided on an adjustment of the company’s strategy towards 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.
- In May, a fully guaranteed new share issue of approximately MSEK 48 was announced.
- In May, the company received a granted patent in the US for prevention of skin scarring.
- In May, Hans-Peter Ostler was elected new member of the board.
- In June, the company announced that the new issue had been concluded, yielding a net MSEK 45.
- In September, Promore Pharma received delivery of hyaluronic acid from Italian manufacturer Fidia.
- In October, Promore Pharma announced that a scientific article had been published on the clinical study results of ropocamptide for venous leg ulcers.
- In November, Promore Pharma received permits to start a Phase II clinical trial regarding scar prevention.
- In December, the company received a granted patent for ropocamptide (LL-37) for the treatment of chronic wounds on the US market.
Events after the reporting period
- 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.
”In November, the year 2021 efforts in the ensereptide project culminated with an approval from the Swedish Medical Products Agency and the ethics authority to start PHSU05, our Phase II study for the prevention of skin scarring.”
Jonas Ekblom, President and CEO of Promore Pharma
Statement of the CEO
The financial year 2021 was an important year for us at Promore Pharma. We made the strategic decision to orient our project regarding ensereptide towards prevention of skin scarring. As a result, we decided to carry out a rights issue of SEK 45 million net. On the one hand, the ownership in the company was broadened, and on the other hand, we received the financial resources required to be able to begin planning and later implement our Phase II study regarding ensereptide (PHSU05).
During the year, we negotiated agreements with reputable service providers for the manufacture of investigational product for the PHSU05 study, and during the autumn we were able to submit a clinical trial application for PHSU05, which was approved by the Medical Products Agency in Sweden during the fourth quarter. In 2021, we thus implemented the first part of the plan we laid out in connection with the new share issue.
In February 2022, slightly ahead of plan, the first subject was recruited to PHSU05. This gives us good hope of also being able to deliver the results from the study according to plan, i.e., during the winter of 2022/2023.
Our product candidate ensereptide is now being developed to inhibit various forms of scarring on the skin. As mentioned above, we adjusted the focus of this project in the spring of 2021. In 2021, we have in worked with preparations for a clinical Phase II trial (PHSU05) in this project. Among other things, we have entered into a manufacturing agreement with the Italian company Fidia for the production of the hyaluronic acid as well as certain manufacturing services. A batch was released according to GMP in late summer for use in the clinical study. The manufacture of the investigational product was completed during the autumn according to plan. In November, important sub-goals were reached in the ensereptide project with an approval from the Swedish Medical Products Agency and the Swedish Ethics Authority to start PHSU05.
We have also made significant progress in the ropocamptide project. We are now working on a technical development of an improved administration form for ropocamptide, where the main purpose is to develop a product that is easier to use. Regardless of whether the company conducts future clinical studies on its own or together with strategic partners, the development of a more user-friendly product is important both in a clinical study environment and when the product reaches the market. This work follows our business plan without deviations.
We are very grateful for the response we received in connection with the capital raise in June 2021. Both existing and several new resourceful shareholders have shown confidence in both the company and the reprioritization of the ensereptide project aimed at the scarring market. The capital injection enables several value-generating steps in Promore Pharma. The perseverance of our main owners, the company’s employees, together with our strategic network, creates a robust company, which means that we have the strength to take on the challenges, temporary or permanent, that our industry is known for. The clearest example in 2020 and 2021 has, of course, been the societal restrictions caused by the COVID-19 pandemic. In Promore Pharma, we have over the past two years managed to advance the positions in our business with a remarkably small impact by the external situation.
In 2022, our most important operational goals are to continue and complete the plan we started in the summer of 2021, namely, to carry out our clinical trial of ensereptide for skin scarring and continue the work of creating a more user-friendly form of the product ropocamptide.
Finally, I would like to express my great gratitude to everyone who has provided support and hard work that made 2021 a fantastic year for Promore Pharma. Not least, I am grateful for the support that our shareholders have shown. It is gratifying to have been able to meet the expectations placed on the company. It is a privilege for me to have been involved in Promore Pharma’s development in recent years, and I feel great enthusiasm to continue to lead the company forward.
Solna, February 16, 2022