Interim report January - March 2017
- Net sales amounted to MSEK 0 (0).
- The operating loss for the reporting period was -3,2 (-2,9) MSEK
- Net loss was 3,3 (-3,1) MSEK, corresponding to a loss per share of SEK 3,65 (3,57)
- Cash flow from operating activities amounted to -2,8 (-7,2) MSEK
- Cash and cash equivalents amounted to 3,8 (9,1) MSEK
Significant events during the period January - March
- A co-operation agreement was signed with the American biotech company Cellastra Inc. regarding the clinical development of PXL01 in North America
- The company formally changed name from Lipopeptide to Promore Pharma
Significant events after the end of the reporting period
- Resolution at the Annual General Meeting 25 April to perform a bonus issue and make the company public
- Share split 15:1 implemented
- Marianne Dicander Alexandersson was elected new board member
- Jonas Ekblom was employed as CEO. He was previously a consultant for the company.
- Filing in India for a PXL01 clinical phase III trial
During the first quarter, the management team was to a large extent focused on preparing the company for an initial public offering on Nasdaq First North, which is planned for during 2017. Promore Pharma has secured funding for a significant part of its activities through strategic partnerships and investments from our main shareholders. However, since late stage pharmaceutical development requires substantial capital resources, and the organization needs to be strengthened with additional regulatory and commercial expertise, it is a natural step to aim for a listing at Nasdaq First North to seek additional capital to secure financing to carry out the clinical studies in all relevant geographies for PXL01 and LL-37. The company has started preparing a prospectus and is conducting a comprehensive legal review. Adviser in the IPO process is Redeye AB.
During the first quarter, a co-development agreement with the American biotechnology company Cellastra Inc. was signed regarding the clinical development of PXL01 in North America (USA and Canada). Cellastra is a San Francisco-based company focused on regenerative medicine. In the agreement, the parties agreed on how to cooperate to conduct a phase III clinical trial of PXL01 for the prevention of post-surgical adhesions after tendon repair surgery. Together, the companies will establish agreements with subcontractors for the operationalization of the US phase III program. Cellastra also has the right to co-finance the investment linked to the implementation of a phase III study for the first indication in the United States. The next significant milestone in this collaboration is a planned meeting with the US Food and Drug Administration (FDA) later in 2017.
Significant planning work has been carried out within the company's research and development initiatives. The clinical study protocol (CSP) has been completed for the planned phase III study on PXL01 in Europe and India. Detailed planning of the manufacturing of the investigational medical products for the same study has begun with the company's strategic partner, PharmaResearch Products Ltd. A clinical trial application was filed with Drugs Controller General in India (DCGI) as the first step of this multi-national clinical trial that will also include European countries, under a protocol to be approved by the European Medicines Agency (EMA).
During the first quarter, a recruitment process has been conducted to identify a new owner-independent board member. Marianne Dicander Alexandersson was nominated by the board's Nomination Committee and was elected to the Board of Directors at the Annual General Meeting on April 25, 2017. Marianne holds a Master of Science in Chemical Engineering from Chalmers University of Technology and has, among other things, served as CEO of Kronan Droghandel, deputy CEO of Apoteket AB, Managing Director of the Sixth AP Fund and GHP AB. At present, she serves in several other boards. In addition, she has served as board director in Mölnlycke Health Care. In the first quarter, we also hired Alexandra Liverts as Office Manager. Alexandra has previously served in the role as Administrative Officer at the Ben-Gurion University in Negev, Israel. Marianne and Alexandra will help to further strengthen our team.
During the second quarter, we will continue our efforts to prepare our planned clinical trials together with our alliance partners and the future listing of the Company.
Thank you for your interest in our work at Promore Pharma.
Solna, 19 May 2017
Jonas Ekblom, CEO
Jonas Ekblom, CEO
Phone: [+1] 714 369 0478
Jenni Björnulfson, CFO
Phone: [+46] 708 55 38 05
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 on patients undergoing tendon repair surgery in the hand and LL-37 that is prepared for a clinical phase IIb study on 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. Rosetta Capital Ltd., Midroc New Technology AB and PharmaResearch Products Ltd. are the main shareholders in Promore Pharma.