Promore Pharma AB (publ) Interim report January – March 2020

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  • Net sales amounted to MSEK 0.0 (0.5) MSEK
  • The operating loss for the period was 7.3 (-5.5) MSEK
  • Net loss was 7.0 MSEK (-5.5) MSEK, corresponding to a loss per share of SEK 0.19 (-0.27)
  • Cash flow from operating activities amounted to -15.0 (-4.4) MSEK    
  • Cash and cash equivalents amounted to 45.9 (26.6) MSEK

Significant events during the period January - March

  • The targeted number of 120 patients completing treatment in the HEAL LL-37 Phase IIb clinical trial with ropocamptide was reached

Significant events after the reporting period

  • The company CFO leaves the company in 2020

CEO Statement

The first months of 2020 have been intense and successful. It is with great satisfaction I am noting that, despite the prevailing situation in the world, Promore Pharma has been able to follow the business plan to date. Because of the ongoing COVID-19 pandemic, many companies in our sector have experienced disruptions in their clinical programs where many have had to completely suspend ongoing studies or put them on hold for some time.

We have made important progress in our project with ropocamptide (LL-37), where a new treatment for venous leg ulcers, the most common chronic wound, is being developed.  It is very satisfying to note that the recruitment and treatment for the subjects in our clinical trial (HEAL LL-37) regarding ropocamptide could be completed during the first quarter. We have achieved the goal of treating approximately 120 patients in accordance with the study protocol. The project has four principal components: (i) an initial period of three weeks when all patients are treated with placebo, (ii) a three-month treatment period with ropocamptide or placebo, (iii) a follow-up period of four months, and finally, (iv) an analysis phase of the study when data is quality assured and analyzed in detail by the company's management and external expert consultants. Our goal is to be able to present final data from the study in the fourth quarter of this year.

If the analysis of data from the ongoing clinical study demonstrates a clear-cut treatment effect of ropocamptide, we believe that we have very good opportunities to create great corporate value since we address a major medical need, and a huge marketplace. Our goal is that the ropocamptide project should be developed towards a treatment of venous leg ulcers that in the future can contribute to both improved treatment outcomes and health-economic benefits.

In the ensereptide project (PXL01), the planning work continues in order to enable the Phase III trial, PHSU03. Ensereptide is a therapeutic peptide intended to prevent the occurrence of unfavorable adhesions with initial focus on surgical repair of injured tendons in the hand. As previously announced, PHSU03 will not commence patient enrolment before additional financing is secured.

The company has not been affected by any significant direct effects of the ongoing COVID-19 pandemic. Opinions on the trajectory of this crisis vary, but one thing experts in various functions seems to agree on is that it will take a long time to reach a normalization. As a result, a large number of uncertainties arise in virtually all sectors of society. For us as a company, this may for example involve delayed interactions with authorities, restrictions in our contacts with health care institutions, capacity constraints of subcontractors, changed priorities in other companies regarding propensity and interest in entering into license agreements and strategic alliances, and uncertainties on the capital markets with potential implications for future fundraising. At present, our overall plans have not been significantly affected, but we are of course constantly working to understand how the COVID-19 pandemic may affect our situation. At the same time, we are reviewing how we can reduce our variable costs to allow for an extension of the time horizon of our current cash holdings, beyond what we had originally planned for.

All in all, our progress in the company's research program gives me great hope for an exciting time ahead of us. We are now primarily awaiting results from our clinical trial of ropocamptide, HEAL LL-37, where we expect to have results by the end of the year. My colleagues and I are convinced that our clinical results in the future will benefit all our stakeholders, not least the patients.

The full interim report is available at https://www.promorepharma.com/en/section/investors/financial-reports/

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

This information is information that Promore Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 13.00 CET on 26 May 2020.

Promore Pharma’s Certified Adviser is Redeye AB.

Phone: [+46] 8 121 576 90

E-mail: certifiedadviser@redeye.se

Promore Pharma in brief:

Promore Pharma is a biopharmaceutical company specialized in the development of therapeutic peptides. The company’s aim is to develop first-in-category pharmaceuticals for indications where very few efficacious prescription pharmaceuticals are available, thus, addressing high unmet medical needs. Promore Pharma’s two projects are in late stage clinical development phase and have a very strong safety profile since they are based on innate substances that are administered locally. The leading project, ensereptide (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. Ropocamptide (LL-37) is being evaluated in 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, adhesions after other surgical procedures and treatment of diabetic foot ulcers. The company is listed on Nasdaq First North Growth Market.

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