Promore Pharma AB (publ) Interim report January – March 2018
- Net sales amounted to MSEK 0.1 (0) MSEK
- The operating loss for the period was 7.9 (loss 3.2) MSEK
- Net loss was 7.9 MSEK (loss 3.3) MSEK, corresponding to a loss per share of SEK 0.39 (loss 0.24)
- Cash flow from operating activities amounted to 8.5 (-2.8) MSEK
- Cash and cash equivalents amounted to 54.4 (3.8) MSEK
Significant events during the period January - March
- Cellastra Inc’s option to receive a license to commercialize PXL01 in North America expired.
- Promore Pharma Regained PXL01 Manufacturing Rights
Significant events after the end of the reporting period
- 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.
Promore Pharmas project portfolio consists of therapeutic peptides, each with a significant medical value in a wide variety of indications for the bioactive wound care market. We are working to position the company as a pioneer within wound healing and prevention of scars and adhesions, and we estimate that the aggregated market potential of Promore Pharma's product candidates is more than 1 billion USD annually, if opportunities for indication broadening, such as DDD, dermal scarring and post-surgical adhesions from other minimally invasive surgical procedures are included. We see 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 are 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. In this context, the out-licensing agreement we recently signed with PharmaResearch Products Ltd (PRP) regarding spinal surgery was particularly gratifying and in line with our strategy. The agreement means that PRP will fully fund the development of PXL01 to prevent fibrosis after degenerative disc disorder (DDD) surgery. The agreement gives Promore Pharma a share of any milestone payments to PRP as well as a double-digit royalty from the global sales of the product. As part of the initial agreement entered between our companies in March 2016, PRP was granted the right to develop and commercialize a medical device product for spinal surgery for certain Asian markets and through the new agreement we expand our strategic alliance.
The first quarter has been characterized by continued preparatory work for our two clinical trials; PHSU03, a phase III study of PXL01 for prevention of adhesions after tendon and nerve repair surgery in the hand, and HEAL LL-37, a Phase II study of LL-37 for treatment of venous leg ulcers. Our goal is to begin the patient enrolment in both of these international clinical studies in the current year. An important focus area has been to execute the detailed planning and implementation of the most important steps in the manufacturing of the investigational medicinal products for both of these clinical trials. The manufacturing of the company's drug products is carried out by a multinational network of external product and service suppliers. Another important focus area has been - and continue to be - the work of identifying clinics across Europe that can optimally help recruit patients to these two clinical trials.
When assessing the global market and our company's competitive position, it can be concluded that the interest in bioactive wound care is continuously increasing. The development of new wound care products is highly cross-disciplinary; new products are developed in several different categories - such as prescription drugs, medical devices and so-called OTC products. The world-wide number of patents submitted annually in the wound care field has been increasing steadily for the last ten years. We continually obtain requests to participate in strategic partnerships involving further applications of our products. I interpret this as a powerful sign of interest in Promore Pharma since we focus on pharmaceutical development for indications currently lacking effective treatment. Our board and management are determined to build Promore Pharma through smart partnership towards becoming a leading biotech company in bioactive wound care. We are convinced that in the medium term this will result in a significant value expansion.
Solna,16 May 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’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.
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 14:30 CET on 16 May 2018.