April to June
- Net sales amounted to MSEK 0 (0).
- The operating loss for the period was 10.8 (profit of 8.5) MSEK
- Net loss was 9.8 (profit of 10.5) MSEK, corresponding to earnings per share of SEK -0.48 (0.69)
- Cash flow from operating activities amounted to -8.6 (10.7) MSEK
- Cash and cash equivalents amounted to 46.0 (14.7) MSEK
January to June
- Net sales amounted to MSEK 0 (0.1).
- The operating loss for the period was 18.7 MSEK (-5.3) MSEK
- Net loss was 17.7 (7.2) MSEK, corresponding to earnings per share of SEK -0.88 (0.53)
- Cash flow from operating activities amounted to -17.1 (7.9) MSEK
Significant events during the period January – June
- Cellastra Inc’s option to receive a license to commercialize PXL01 in North America expired.
- Promore Pharma regained PXL01 manufacturing rights
- Out-licensing agreement for PXL01 signed with PharmaResearch Products Ltd (“PRP”) meaning PRP will finance the development of PXL01 for use to prevent fibrosis after spinal surgery.
Significant events after the end of the reporting period
- Approval to start the LL-37 Phase II study on patients with chronic wounds from the Medicinal Product Agency in Sweden
The first half of the year has been characterized by continued preparatory work for our two clinical development programs – PHSU03, a Phase III study with our leading drug candidate PXL01 for prevention of postsurgical adhesions after tendon and nerve repairs in the hand, and HEAL LL-37, a Phase II study with our second main clinical program, LL-37 for the treatment of venous leg ulcers. Our goal is to begin both of these international studies in the current year. The activities of the first half of the year paid off after the end of the period in July, with the approval of the Swedish Medical Products Agency to begin the HEAL LL-37. I would like to take this opportunity to thank the team for a work well done, where problems were solved, among others due to a strong collaboration with CMO APL and CRO PCG.
Clinical development projects of this type are complex and are always associated with a variety of uncertainties that may affect the timeline, which is mostly evident in the PXL01 program where several more contract research organizations and contract manufacturing organizations are involved. We continue to work with the aim to submit national clinical trial applications and move to the next level in the Phase III Study with PXL01 in 2018.
However, in recent months, we have been working intensively to solve a number of trial-related obstacles. We are constantly working to fine-tune the coordination between the various pharmaceutical manufacturers that contribute to the production of our investigational drug. Our team has also spent a lot of time and commitment in selecting the hospitals that we believe will assist with patient recruitment in an optimal fashion in this multinational phase III trial. These challenges do not in any way affect the overall objectives of the project, but may possibly result in some delays of the project. We will be working this fall to eliminate as many of these uncertainties as possible.
During the second quarter, we signed an out-licensing agreement with the Korean company PharmaResearch Products Ltd. (PRP) regarding the use of PXL01 in spinal surgery. We envision multiple potential applications for PXL01. Promore Pharma has limited resources, and we therefore believe that investments in our technology and our products from strategic and competent partners offer an attractive opportunity for us to broaden the use of our technology base. In this way, we can bring more products to the market and thereby raise the value of our business.
The agreement that we signed with PRP, means that PRP will fully finance the global development of PXL01 to prevent fibrosis after surgical intervention in degenerative disc disorder (DDD) surgery. The agreement offers Promore Pharma a share in any future milestone payments to PRP as well as double-digit royalties from the global sales of the product. The agreement was thus an important step in our strategy to develop our product candidates towards multiple indications.
We estimate that the aggregated market potential of Promore Pharma’s product candidates amounts to more than 1 billion USD annually, when opportunities for indication broadening, such as DDD, dermal scarring and post-surgical adhesions from other minimally invasive surgical procedures are included. Additionally, we also recognize that in the LL-37 program
there is a high potential to broaden the indications to include for example diabetes foot ulcers.
During the second quarter, we also had our Annual General Meeting, and as CEO of Promore Pharma, I am very pleased and grateful that the company’s Board of Directors were re-elected. Today, the Board consists of Göran Pettersson (Chairman of the Board), Marianne Dicander Alexandersson, Torsten Goesch, Satyendra Kumar and Göran Linder. I feel that the current board and the company’s management group have evolved into a strong and dynamic team with the aim of positioning the company as a pioneer in the treatment of wounds and prevention of scars and adhesions.
Finally, I would like to thank you for your interest in Promore Pharma.
Solna 20 August 2018
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 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 has two projects, PXL01 and LL-37, 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 and LL-37 that is prepared for 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 and treatment of diabetic foot ulcers. The company is listed on Nasdaq First North with Redeye AB as Certified Adviser.
This information is information that Promore Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 16:00 CET on 20 August 2018.