Promore Pharma AB (publ) Interim report January – March 2019
- Net sales amounted to MSEK 0.5 (0.1) MSEK
- The operating loss for the period was 5.5 (loss 7.9) MSEK
- Net loss was 5.5 MSEK (loss 7.9) MSEK, corresponding to a loss per share of SEK 0.27 (loss 0.39)
- Cash flow from operating activities amounted to -4.4 (-8.5) MSEK
- Cash and cash equivalents amounted to 26.6 (54.4) MSEK
Significant events during the period January - March
- Phase III trial with PXL01 modified and the number of clinics in the study expanded
Promore Pharma's most important task is to develop new products aiming to improve the quality of life for patients with difficult-to-treat wounds and various types of scarring, primarily following surgery. We have continued to develop the company's innovative projects within two treatment areas, both having significant medical needs since the treatment options are poor or absent. The projects are proceeding in line with our business plan.
Both our projects are in late clinical phase and the project that has reached the furthest is the PXL01 program. We are preparing a Phase III clinical trial (PHSU03) with PXL01 where we intend to prevent permanent and undesirable adhesions after tendon repair surgery. In November 2018, the clinical study protocol for PHSU03 was approved by the Drug Controller General of India (DGCI). What remains to be done before we can start recruiting patients to PHSU03, is to finalize the production chain for the experimental drug and to apply and obtain approval from the different national authorities of the European countries where the study will also be conducted.
As for our second development initiative, LL-37 for the treatment of venous leg ulcers, the clinical phase IIb study HEAL, which was started in the third quarter of 2018, progresses satisfactorily. We continue to include patients in Sweden and Poland for the study, where we are planning for about 120 patients to complete the clinical study protocol. Final results after completion of the three-month treatment study are expected to be available by 2020. The primary evaluation criterion is the proportion of completely healed wounds, which is what regulatory authorities also request in confirmatory studies for market approval. With a successful study outcome, we hope to out-license LL-37 to a larger pharmaceutical company having the appropriate configuration of conducting phase III trials and supporting the launch of a future product in the global marketplace.
I am content with the ongoing development of the project portfolio during the quarter and that Promore Pharma has continued to make progress in accordance with our business plan. Promore Pharma is well-positioned to continue to drive the projects forward and to launch new potential value-creating partnerships in the long term in accordance with the company's strategy.
In conclusion, I would like to thank everyone who has contributed to a successful quarter and the beginning of the fiscal year 2019.
Solna, 21 May 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
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 13:00 CET on 21 May 2019.
Promore Pharma’s Certified Adviser is Redeye AB.
Phone: [+46] 8 121 576 90
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.