October to December 2019
- Net sales amounted to 1.5 (1.4) MSEK.
- The operating loss for the period was 4 (-6.5) MSEK
- Net loss was 4 (-7.2) MSEK, corresponding to a loss per share of SEK 0.38 (-0.35)
- Cash flow from operating activities amounted to -0.3 (-8.7) MSEK
- Cash and cash equivalents amounted to 60.5 (30.9) MSEK
January to December 2019
- Net sales amounted to 3.9 (2.4) MSEK.
- The operating loss for the period was 1 MSEK (-32.7) MSEK
- Net loss was 28.9 (-32.5) MSEK, corresponding to a loss per share of SEK 1.16 (-1.61)
- Cash flow from operating activities amounted to -18.5 (-32.5) MSEK
Significant events during 2019
- Phase III trial with PXL01 modified and the number of clinics in the study expanded
- Kerstin Valinder Strinnholm elected member of the Board of Directors
- Patent granted for LL-37 in Japan
- The Board of Directors resolved on a rights issue of 75 MSEK, guaranteed to 80 percent
- ABG Sundal Collier engaged as liquidity provider
- Patent granted for PXL01 in USA
- Rights issue completed
- HEAL LL-37 recruitment completed early. In June, half of the patients were recruited.
Significant events after the end of the reporting period
No significant events after the reporting period
At Promore Pharma, we are driven by a long-term commitment to research and development that can lead to drugs which can significantly improve the lives of patients with hard-to-heal wounds and various types of scarring, mainly as a result of surgery. These conditions are causing pain, reduced mobility and impaired quality of life. We are confident that our drug projects have an important place to fill in this market segment as they may imply a big change for patients who currently lack suitable treatment. With an efficient organization along with a clear focus on two projects with a strong safety profile, being in late stage clinical phase, the development risks are lower for Promore Pharma than for most innovation companies in the pharmaceutical sector. We can also carry out studies at a lower cost than what is customary in several other therapeutic areas.
It is very satisfying to note that the recruitment in our clinical trial with LL-37 (HEAL LL-37) for the treatment of venous leg ulcers, not only followed plan in 2019, but could be completed ahead of schedule. We announced in December that we had completed the recruitment when we estimated that we had included enough patients to reach the goal of having 120 patients completing the entire study protocol. The project has four principle components: (i) an initial period of three weeks when all patients are treated with placebo, (ii) a three-month treatment period with LL-37 or placebo, (iii) a follow-up period of four months, and finally, (iv) an analysis phase of the study where data is quality-assured and analyzed in detail by the company’s management and external expert consultants. We expect to be able to present final data from the study during the fourth quarter of this year. As we have previously announced, the schedule will be further defined during the course of the year. We believe that we have a very good opportunity to create great value by addressing a very large market; it is estimated that the cost of treating a single venous leg ulcer can exceed 10,000 USD per event. The number of patients in the traditional drug markets is estimated at 13-18 million. Our goal is to develop the LL-37 project towards a treatment that can contribute to both improved treatment results and healthcare economy in the future.
During 2019, we have also taken important steps in our other program, PXL01, regarding the preparation of PHSU03, our upcoming phase III study. Our team has worked focused to prepare the manufacturing of investigational medicinal product for PXL01, which is the activity that constitutes the critical timeline for our clinical trial applications for PHSU03 in a number of EU countries. The work has included evaluation of several manufacturing alternatives. Together with a supplier, we conducted a meeting with the Swedish Medical Products Agency in May, in a so-called industrial dialogue. We are very pleased with the outcome of the meeting, as several uncertainties could be eliminated.
In the end of 2019, we carried out a rights issue, which resulted in a net capital injection of approximately SEK 48 million, which provides the monetary resources for the coming year. Our most important operational goals for 2020 are to complete and compile data from HEAL LL-37 and to complete all preparatory work for PHSU03, so that this clinical phase III trial can start as soon as complementary capital has been secured in the form of a new share issue or with funds from a strategic deal.
We are in the very last part of the product development chain with both our projects. It is worth emphasizing that only a very small proportion of projects in our industry reach this far. We also believe that our two clinical programs have very strong opportunities to succeed: firstly, the drug candidates have a very strong safety profile, and secondly, because of the late clinical phase, many risks have already been eliminated. A common reason for late stage clinical phase failures relates to discovery of unexpected side effects. Our projects are based on endogenous substances that are administered locally and in addition are rapidly degraded in the blood stream. Therefore, the risk of unexpected side effects is almost non-existent, especially with regard to PXL01, which is administered on a single occasion only in conjunction with a surgical procedure.
Finally, I would like to express my gratitude for all the hard work that made 2019 a year of significant progress for Promore Pharma. By continuing to develop the company’s two assets towards market registration and at the same time opportunistically seeking new strategic alliances that broaden the medical use of our projects, we can continue to deliver value to our shareholders.
Solna 18 February 2020
President and CEO
For additional information, please contact
Jonas Ekblom, CEO
Phone: [+46] 736 777 540
Jenni Björnulfson, CFO
Phone: [+46] 708 55 38 05
Promore Pharma’s Certified Adviser is Redeye AB.
Phone: [+46] 8 121 576 90
The full interim report is available at https://www.promorepharma.com/en/section/investors/financial-reports/
This information is information that Promore Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 16.00 CET on 18 February 2020.
Promore Pharma in brief:
Promore Pharma is a biopharmaceutical company specialized in the development of therapeutic peptides. The company’s aim is to develop first-in-category pharmaceuticals for indications where very few efficacious prescription pharmaceuticals are available, thus, addressing high unmet medical needs. Promore Pharma’s two projects are in late stage clinical development phase and have a very strong safety profile since they are based on innate substances that are administered locally. The leading project, PXL01, that will be used for prevention of post-surgical adhesions and scars, is being prepared for clinical phase III-studies in patients undergoing tendon repair surgery in the hand. LL-37 is being evaluated in a clinical phase IIb study in patients with venous leg ulcers (VLU). The product candidates can also be deployed for other indications, such as preventing dermal scarring, adhesions after other surgical procedures and treatment of diabetic foot ulcers. The company is listed on Nasdaq First North Growth Market