Interim Report January - September 2021
STOCKHOLM, SE / ACCESSWIRE / November 23, 2021 /Promore Pharma (STO:PROMO) (FRA:8T0)
July to September
- Net sales amounted to MSEK 0 (0)
- Net loss was MSEK -6.1 (-8.1), corresponding to earnings per share of SEK -0.11 (-0.22)
- Cash flow after financing activities amounted to MSEK +39.1 (-8.6)
- Cash amounted to MSEK 52.1 (31.3). The funds from the new share issue was transferred in July
January to September
- Net sales amounted to MSEK 0 (0)
- Net loss was MSEK -21.1 (-21.7), corresponding to earnings per share of SEK -0.49 (-0.60)
- Cash flow after financing activities amounted to MSEK +27.9 (-29.2)
Significant events during January - June
- In September Promore Pharma received delivery of hyaluronic acid from Italian manufacturer Fidia.
Events after the reporting period
- In October, Promore Pharma announced that a scientific article had been published on the clinical study results of ropocamptide for venous leg ulcers
- In November, Promore Pharma received permits to start a Phase II clinical trial regarding scar prevention
"In November, this year's efforts in the ensereptide project culminated with an approval from the Swedish Medical
Products Agency and the ethics authority to start PHSU05, a Phase II study with ensereptide for the prevention of skin scarring."
Jonas Ekblom, President and CEO of Promore Pharma
Comments from the CEO
The year has been both intense and successful. We have made operational progress and reached several important milestones during the first three quarters of the year and are now working in full alignment with the new strategy for the projects ensereptide and ropocamptide that were implemented in the spring of 2021.
Ensereptide is a product candidate that is being developed to inhibit skin scarring. In this project, we worked during the year with preparations for a clinical trial. Among other things, we have entered into a manufacturing agreement with the Italian company Fidia, for the production of hyaluronic acid. A manufacturing batch was released according to GMP during the late summer for use in our upcoming clinical study. During the autumn, a number of other manufacturing activities take place.
In November, this year's efforts in the ensereptide project culminated with an approval from the Swedish Medical Products Agency and the ethics authority to start PHSU05, a Phase II study with ensereptide for the prevention of skin scarring. PHSU05 is a pilot study with the aim of assessing ensereptide regarding (i) local tolerance, (ii) the application process for the experimental drug, and (iii) preliminary efficacy on scar prevention after experimentally induced wounds in healthy volunteers. The trial is planned for a start in Q1 2022 and results from the study are expected in the winter of 2022/2023.
Within the ropocamptide project, we have also made significant progress. Ropocamptide is being developed as a new treatment for venous leg ulcers, which is the most common type of chronic leg ulcer. In the project, a Phase II trial, the HEAL LL-37 study, was completed in the autumn of 2020. The most important finding from the clinical trial was that ropocamptide shows a clear treatment effect in the subgroup of patients who had large wounds (≥10 cm2). We have also worked with Dr. Jean-Charles Kerihuel, who is an important international key opinion leader. He has contributed with analyzes and assessments that we will benefit from in our discussions regarding strategic partnerships related to ropocamptide.
Promore Pharma is now conducting technical development of the administration form for ropocamptide to improve the product. The purpose of this technical development is to bring forward a product that is easier to use. Regardless of whether the company conducts future clinical studies alone or together with strategic partners, the development of a more user-friendly product is important both in a clinical study environment and when the product eventually reaches the commercial stage. This work is well aligned with our operations plan.
An article about the results from the clinical trial HEAL LL-37 has been published in the journal Wound Repair and Regeneration, which is the journal of the International Wound Healing Society. Co-authors of the article are several internationally renowned subject area experts, including professors Jan Apelqvist, Arkadiusz Jawien, and Folke Sjöberg. We are very pleased that the results from HEAL LL-37 are now published and available to the scientific community and the general public. The publication is a confirmation of the quality of the completed clinical study, which was completed at the end of 2020.
In the company, we are now working on the planning for the coming financial year. We feel secure with our new strategic direction and our financial position, which means that we have sufficient capital to i) conduct PHSU05; ii) develop a single-component product for future studies with ropocamptide; iii) acquire ropocamptide for future clinical trials, and; iv) continue the work of finding strategic partners.
Overall, our progress in our development program gives me great hope for the company's future. My co-workers and I are fully convinced that our ultimate end results will benefit all our stakeholders, not least the patients.
Solna, November 23, 2021
For additional information, please contact
Jonas Ekblom, CEO
Phone: [+46] 736 777 540
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 with high unmet medical needs, where very few efficacious prescription pharmaceuticals are available. Promore Pharma's two projects are undergoing clinical development and have a very strong safety profile since the products are based on endogeneous substances that are administered locally. The leading project, ensereptide (PXL01), that will be used for prevention of post-surgical scarring, is being prepared for a clinical phase II-trial if the peptide can prevent the formation of unesthetical scars on the skin. Ropocamptide (LL-37) has recently been evaluated in a clinical phase IIb study with positive results in patients with venous leg ulcers (VLUs). The product candidates can also be deployed for other indications, such as preventing unfavorable tissue attachments (adhesions) after different kinds of surgical procedures and treatment of diabetic foot ulcers. The company is listed on Nasdaq First North Growth Market.
Link to the report on our site
The full interim report is available at https://www.promorepharma.com/en/section/investors/financial-reports/
SOURCE: Promore Pharma
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