Interim report January – September 2017

CEO statement

Since the IPO in July, Promore Pharma is in an intense stage of development and the sense of anticipation and hope for the future is strong among the board of directors, management and staff. Overall, the company’s main activities during the third quarter have been focused on continued planning of our clinical commitments.

In accordance with our plan, the majority of resources have been allocated towards the development of PXL01 – a therapeutic peptide that has the potential to be the first drug product in the world to prevent adhesions that occurs after surgical repair of damaged tendons. In the planning for the upcoming the Phase III clinical trial, also referred to as the PHSU03 trial, which aims to result in the basis for market authorization of PXL01 in Europe for use in tendon- and nerve-repair procedures in the hand, lower arm and foot, we are conducting parallel activities that include investigational medicinal product manufacturing, along with validation of clinical sites in Sweden, Poland, Germany and India. The current assessment suggests that it may be relevant to add additional countries in Europe to improve the recruitment base for the study. The goal is to begin the enrolment of patients in 2018. Manufacturing of investigational medicinal product is currently a so-called critical timeline activity.

The company’s ambition is also to carry out a similar Phase III clinical trial of PXL01 in North America in order to achieve market authorization in the US and Canada. However, the share issue in connection with our IPO generated less capital than originally aimed for. This means, that if our North American partner, Cellastra Inc., does not finance the Phase III program in US, it may be postponed until other funding can be secured. Nonetheless, Promore Pharma, aims to conduct as much preparatory efforts in the project as feasible and plans for a dialogue with the US Food and Drug Administration (USFDA) in the first half of 2018.

Following PXL01, our second most important program is LL-37. The LL-37 peptide has a strong potential to be the first drug product for the treatment of venous leg ulcers, a major treatment area that currently lacks pharmaceutical prescription products. In this initiative, the Company is preparing for a Phase IIb clinical trial (LL37002). We are pleased about the fact, that during September and October, we have taken important steps through the agreements with APL and PCG Clinical Services AB. APL will be responsible for process development and subsequent manufacturing of investigational medicinal product for the planned LL37002 study. PCG Clinical Services will act as Clinical Research Organization (CRO) and manage the clinical trial which is expected to start in 2018.

In addition to PXL01 and LL-37, Promore Pharma has a number of substances in which we do not actively invest research and development resources. The peptide DPK-060 is one of these. In November, an extensive European research collaboration, funded by a research grant from the EU’s 7th Framework Program, FORMAMP project, will be concluded. The purpose of the FORMAMP project has been to identify new advanced formulations of antimicrobial peptides, including DPK-060. In this development work, we have gained new insights regarding the development of new stable and efficacious dosage forms of peptides such as DPK-060. This has resulted in new business development opportunities for Promore Pharma, and it is therefore gratifying that in November we entered into a license agreement regarding DPK-060 with the American biotechnology company Transdermal Therapeutic Technologies LLC. Our American partner will take responsibility for all further research, development and business partnering. If these efforts result in a future product based on DPK-060, Promore Pharma will be entitled to a double-digit royalty.

We have had a very eventful third quarter and we still focus on our long-term goal of becoming a future market leader in bioactive wound care. Progress in our research programs offers us an excellent position for further growth and value generation.

Solna, 21 November 2017

Jonas Ekblom
President and CEO

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

Street address: Fogdevreten 2, 171 65 Solna, Sweden
Website: www.promorepharma.com
Corporate registration number: 556639-6809

Promore Pharma in brief:

Promore Pharma is a biopharmaceutical company specialized in the development of therapeutic peptides for the bioactive wound care market. The company’s aim is to develop two first-in-category products for indications where very few efficacious prescription pharmaceuticals are available, thus, addressing high unmet medical needs. Promore Pharma’s two projects, PXL01 and LL-37, are in late stage clinical phase. 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 prepared for a clinical Phase IIb study in patients with venous leg ulcers. The product candidates can also be deployed for other indications, such as preventing dermal scarring and treatment of diabetic foot ulcers. The company is listed on Nasdaq First North with Redeye AB as Certified Adviser.