Promore Pharma AB (publ) Interim report January - June 2019
April to June
- Net sales amounted to 0.7 (0) MSEK.
- The operating loss for the period was 7.4 (-10.8) MSEK
- Net loss was 7.3 (- 9.8) MSEK, corresponding to earnings per share of SEK -0.36 (-0.48)
- Cash flow from operating activities amounted to -6.9 (-8.6) MSEK
- Cash and cash equivalents amounted to 19.7 (46.0) MSEK
January to June
- Net sales amounted to 1.2 (0.1 MSEK).
- The operating loss for the period was 12.9 (-18.7) MSEK
- Net loss was 12.8 (-17.7) MSEK, corresponding to earnings per share of SEK 0.63 (-0.88)
- Cash flow from operating activities amounted to -11.3 (-17.1) MSEK
Significant events during the period January - June
- 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
- Half of the patients have been recruited in HEAL LL-37
Events after the reporting period
- Patent granted for LL-37 in Japan
The first half of the year has been characterized by continued work to develop the company's innovative projects in two treatment areas, both of which have significant medical needs because the current treatment options are less effective or non-existent. The clinical trial HEAL LL-37 is progressing fully in line with our business plan and we have made progress in our continued efforts to secure the manufacturing of PXL01.
Both of our projects, LL-37 and PXL01, are in the late clinical phase and the project that has advanced the furthest is the PXL01 program where we are preparing a Phase III clinical trial (PHSU03). We intend to prevent permanent adhesions, after tendon repair surgery. In November 2018, the clinical trial protocol for PHSU03 was approved by the Indian medical authority (Drug Controller General of India, DGCI). What remains to be done before we can start recruiting patients for PHSU03 is to complete the supply chain for investigational medicinal product and to apply for and obtain approval from the national authorities of the countries in the European Union where the study also will be conducted. We are very satisfied with the outcome of the meeting we held together with one of our suppliers at the Swedish Medical Products Agency in May, in a so-called industrial dialogue. As a result of this meeting, several uncertainties have been eliminated and we are convinced that we will be able to carry out the production of investigational product in accordance with a more definite timetable, which aims to start patient recruitment to PHSU03 in the first half of 2020.
With respect to our second project, LL-37 for the treatment of venous leg ulcers, the Phase IIb clinical trial HEAL, which was started during the third quarter of 2018, is progressing according to plan. We continue to include patients in Sweden and Poland. The aim is that approximately 120 patients should complete the clinical study protocol. In June, we completed enrolment of approximately half of the patients. If the current recruitment rate is sustained, all patients should be included and randomized in early 2020 and we anticipate having final results from the study concluded later in 2020.
During the second quarter we also had our annual general meeting. It is gratifying that the former board was re-elected and also that Kerstin Valinder Strinnholm was added as an independent board member. Kerstin Valinder has more than 30 years of experience in strategic planning and business development from the pharmaceutical industry. This gives us further breadth and experience as we gradually approach opportunities to enter into strategic partnerships and out-licensing deals. The Board of Promore Pharma continuously evaluates alternatives to secure the company's long-term financing. To this end, and to investigate several different strategic options, the company has engaged ABG Sundal Collier as financial advisor.
I feel that the current Board of Directors and the company's management have evolved into a strong and dynamic team with the ambition to positioning the company as a pioneer in the treatment of wounds and the prevention of scars and adhesions. Finally, I want to say that I am confident that the company has appropriate strategic goals to continue to build value that result in financial rewards for its shareholders.
Solna 28 August 2019
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 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 has initiated 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.
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 14:00 CET on 28 August 2019.
Promore Pharma’s Certified Adviser is Redeye AB.
Phone : [+46] 8 121 576 90