June – September
- Net sales amounted to 1,3 (1,0) MSEK.
- The operating loss for the period was 6,7 (-7,4)
MSEK - Net loss was 6,7 (-7,6) MSEK corresponding to earnings per share of SEK -0,33 (-0,38)
- Cash flow from operating activities amounted to -6,9 (-6,7) MSEK
- Cash and cash equivalents amounted to 13,0 (39,5) MSEK
January – September
- Net sales amounted to 2,5 (1,1) MSEK
- The operating loss for the period was 19,6
(-26,1) MSEK - Net loss was 19,5 (-25,3) MSEK corresponding to earnings per share of SEK -0,96 (-1,25)
- Cash flow from operating activities amounted to -18,2 (-23,8) MSEK
Significant events during the period January – September
- 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
- Patent granted for LL-37 in Japan
Events after the reporting period
- The Board of Directors resolved on a rights issue of 75 MSEK, guaranteed to 80 percent, where the subscription period is ongoing
- ABG Sundal Collier engaged as liquidity provider
CEO Statement
The first nine months of 2019 have meant significant work in product development, financing and strategic business development, and these initiatives have helped us to further reach our strategic goal; to develop two drugs, the first of their kind, in bioactive wound care, LL-37 and PXL01.
The third quarter of the year was characterized by continued work within our two clinical development programs – HEAL LL-37, which is a phase II study with LL-37 for the treatment of venous leg ulcers, and PHSU03, where we prepare a phase III trial with our drug candidate PXL01 for prevention of adhesions occurring after tendon and nerve repair surgery in the hand.
The Phase IIb clinical trial of the LL-37 project (HEAL LL-37) is proceeding according to plan. The goal of the clinical trial is to evaluate the medical effect of two doses of LL-37 versus placebo. The aim is that approximately 120 patients shall complete the entire study protocol, which has three overall stages; (i) a three-week run-in period where all patients are treated with placebo with the purpose of identifying patients who do not have a chronic wound; (ii) randomization and treatment period when patients are treated with either LL-37 or placebo for three months; and (iii) a four-month follow-up period. During the second quarter of this year, we announced that approximately 50% of patients have been included. We intend to be able to complete the recruitment for the study at the beginning of the coming year.
During the third quarter, we began work on preparing a capital increase, in the form of a rights issue. The subscription period for the rights issue continues until November 28. With this share issue, we are securing the capital required for approximately one year. With these resources we will be able to complete the clinical trial HEAL LL-37 and prepare for the Phase III study with PXL01.
Regarding our Phase III clinical trial with PXL01, PHSU03, we have worked in the past year to optimize the production process and solve some remaining issues around the supply chain for the investigational medicinal product. We are constantly working to fine-tune the coordination between the various manufacturers that are involved in the production of our investigational drug, reduce significant uncertainties and raise the quality of the process. The work with the preparations for the PXL01 clinical phase III study continues, but additional capital will be required to initiate the recruitment of patients. In parallel with the work to secure capital, the company is constantly investigating new strategic alternatives that will enable us to reach our final goal of developing to drugs within bioactive wound care faster.
A couple of weeks ago we received another patent for PXL01 approved in the USA. This was an important step in our strategic work to create far-reaching intellectual property protection for our innovative prescription drug for the prevention of post-surgical adherence, and in this effort, it is essential to have long-term patent protection in the world’s largest pharmaceutical market.
At Promore Pharma, we are now working on planning for the coming operating year. Our progress in the company’s research program in 2019 gives me great hope for an exciting time ahead of us.
The full interim report is available at https://www.promorepharma.com/en/section/investors/financial-reports/
For additional information, please contact
Jonas Ekblom, CEO
Phone: [+46] 736 777 540
Email: jonas.ekblom@promorepharma.com
Jenni Björnulfson, CFO
Phone: [+46] 708 55 38 05
Email: jenni.bjornulfson@promorepharma.com
Promore Pharma’s Certified Adviser is Redeye AB.
Phone: [+46] 8 121 576 90
E-mail: certifiedadviser@redeye.se
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 08.45 CET on 22 November 2019.
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 Growth Market..