Year-end report 2017
October to December
- Net sales amounted to MSEK 0.6 (0)
- The operating loss for the period was 10.6 (loss 3.6) MSEK
- Net loss was 11.0 (loss 2.4) MSEK, corresponding to a loss per share of SEK 0.54 (loss 0.18)
- Cash flow from operating activities amounted to 0.3 (-2.2) MSEK
- Cash and cash equivalents amounted to 63.0 (6.5) MSEK
January to December
- Net sales amounted to MSEK 0.6 (0)
- The operating loss for the period was 9.7 (loss 7.5) MSEK
- Net loss was 8.6 (loss 7.1) MSEK, corresponding to a loss per share of SEK 0.52 (loss 0.53)
- Cash flow from operating activities amounted to -6.9 (-10.0) MSEK
Significant events during 2017
- The company formally changed name from Lipopeptide AB to Promore Pharma AB
- A collaboration agreement was signed with the American biotech company Cellastra Inc. regarding the clinical development of PXL01 in North America
- A resolution was made to perform a bonus issue and make the company public
- Share split 15:1 implemented
- Marianne Dicander Alexandersson was elected as a new board member
- Jonas Ekblom was employed as CEO. He was previously a consultant for the company.
- Submission of a clinical trial application in India for a PXL01 clinical Phase III trial
- Submission of a patent application in the US for the PXL01 product composition
- Milestone payments received from PharmaResearch Products Ltd
- Subscription of shares using warrants was made
- Share issue in connection with the listing on Nasdaq First North in June raised 76 MSEK before deduction of transaction costs
- Trading in Promore Pharma’s shares and warrants (TO1) was initiated on Nasdaq First North on 6 July 2017
- Out-licensing Agreement signed with Transdermal Therapeutic Technologies LLC for DPK-060
Significant events after the end of the reporting period
- Cellastra Inc’s option to receive a license to commercialize PXL01 in North America expired.
2017 was an important year for us at Promore Pharma. We made the historical decision to conduct a listing on Nasdaq First North, which means that we have been able to broaden the ownership base in the company and brought the resources required to initiate two clinical studies: a Phase III study on PXL01 in patients undergoing tendon repair surgery in the hand and a Phase II study on LL-37 for the treatment of venous leg ulcers. During the year we also negotiated agreements with reputable service companies for the manufacturing of Investigational Medicinal Products and the conduct of clinical trials. We intend to conduct the Phase III clinical trial on PXL01 under a European protocol, but also recruit patients in India. We have therefore, in 2017, submitted a clinical trial application to the Drugs Controller General in India. In parallel, our team has been working strenuously to prepare the manufacturing of the investigational medicinal product for the study. To submit a clinical trial application in a European country requires that the manufacturing process is complete and is thus an activity that is on a so-called critical timeline for clinical trial application and the initiation of the study. We believe our clinical programs have excellent opportunities to succeed: on the one hand, the drug candidates have a very strong safety profile, and in addition our two leading projects are in late stage clinical phase, which means that many major risks have already been eliminated. A common reason for failure in late stage clinical phase relates to unexpected side effects. Our products are based on innate substances that are administered locally but also break down rapidly in the bloodstream. Therefore, the risk of unexpected adverse events is almost non-existent, especially with PXL01, which is administered once in conjunction with a surgical procedure. We are also driven by a long-term commitment to development initiatives that can lead to pharmaceuticals which can significantly improve life for patients suffering from pain, reduced mobility and impaired quality of life. We believe that our projects have an important role to play in this new segment within bioactive wound care, where they can offer a big change for patients who are currently lacking treatment. With a clear focus on two projects with a strong safety profile in late stage clinical phase and an efficient organization, we have a strong opportunity to create great values without taking the high financial risk that is common in research companies in the pharmaceutical industry.
The perseverance of our main owners and company management - together with our strategic partnerships - creates a robust business, which means we have the ability to cope with the set-backs, temporary and permanent, for which our industry is well-known. The most obvious example in 2017 was, of course, that Cellastra did not secure funding for the development of PXL01 in North America. Implementing our model in practice means that we must constantly evaluate our working methods and look for the most effective solutions. There will be a delay in North America, but we continue to prepare the project to lose as little time as possible and plan for a dialogue with the US drug agency FDA in the first half of 2018. We are also trying to find a path towards financing of the project, which could include Cellastra if they raise the capital they aspire to, but it is also a natural part of our business to constantly seek new strategic partners to collaborate with.
For 2018 our main operational goals are to continue pushing our main projects forward by start recruitment in the clinical trials of PXL01 and LL-37. By continuing the work of developing these programs towards market registration and in parallel, opportunistically and continuously seek new strategic alliances that broadens the use of our assets, we can continue to deliver value to our shareholders.
Finally, I would like to express my gratitude for all the support and hard work that made 2017 a wonderful year for Promore Pharma. Not least, I am grateful for the support our shareholders have demonstrated, and it is gratifying to have been able to meet the expectations presented. It is a privilege for me to have participated in Promore Pharma's success in recent years, and I feel very enthusiastic about continuing to lead the company forward.
Solna, 6 February 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.