Interim report July-September 2017
Important events during the third quarter 2017
- In August, the initial analysis of the results of the Phase I extension study was presented. The results verified that C21 is well tolerated and safe in a group with a potentially compromised metabolic situation. In addition, the study indicated positive effects on lipid metabolism.
Important events after the period
- In October, data from the in-depth analysis of the Phase I extension study was presented. The analysis strengthens previously published data showing beneficial metabolic effects with C21, and is the first demonstration of pharmacodynamic effects in humans for C21 and indeed for the pharmacological principle of AT2 receptor stimulation.
Financial summary (group)
| KSEK | July-Sept 2017 |
July-Sept 2016 |
Jan-Sept 2017 |
Jan-Sept 2016 |
Year 2016 |
| Operating profit/loss | – 1 685 | -1 587 | -6 512 | -4 847 | -6 649 |
| Profit/loss after financial items | – 1 687 | -1 588 | -6 573 | -4 850 | -6 652 |
| Earnings per share, SEK | -0,11 | -0,10 | -0,31 | -0,26 | -0,54 |
| Equity as per 30 September | 119 557 | 77 398 | 119 557 | 77 398 | 75 597 |
| Cash flow from operating activities | -1 718 | -1 027 | -8 409 | -7 490 | -7 289 |
| Cash flow from investing activities | -5 772 | -3 093 | -13 665 | -9 085 | -13 940 |
| Cash and cash equivalents as per 30 September |
32 734 | 8 918 | 32 734 | 8 918 | 4 265 |
CEO comments
Dear shareholders,
Here is a summary of significant events that took place during the third quarter.
Final preparations for Phase IIa study
The preparatory work to initiate the Phase IIa study on Idiopathic Pulmonary Fibrosis (IPF) is ongoing and is now in the final phase. An application to start the study is expected to be submitted before the end of the year. Approval to commence the study is then expected in Q1, 2018. We are happy to announce that our focus on fibrotic diseases with orphan drug status have allowed us to accelerate the development with C21. We will be able to inform more in-depth about the study plan in upcoming reports.
Positive results from phase I extension study
During the quarter, we published the results from the Phase I extension study. The initial biomarker analysis published in August verified that C21 was well-tolerated and safe in a group with a potentially compromised metabolic situation. In an in-depth analysis with additional biomarkers published in early October, besides safety and tolerability, beneficial metabolic effects with C21 were revealed.
C21 demonstrated clinically relevant protective effects on blood lipids; a decrease in plasma LDL (Low-Density Lipoprotein – harmful cholesterol) and an increase in HDL (High-Density Lipoprotein – good cholesterol) for the C21 group but not for the placebo group. We could see these effects in the initial analysis, but it was only after the in-depth analysis that we could confirm them with statistical significance. This is the first demonstration of pharmacodynamic effects in humans for C21 and indeed for the pharmacological principle of AT2 receptor stimulation.
Updated strategy
During the autumn, the Board and Management have conducted a strategic review to further clarify and streamline the Company’s work. In short the strategy means that the company will continue to focus on developing C21 for fibrotic diseases with orphan drug designation.
The clinical development of C21 on the IPF indication is our main focus. In addition we are actively searching for a second indication withing the area which will allow us to accelerate the development through a focused knowledge and generation of data. Pulmonary arterial hypertension (PAH) och fibrotic kidney diseases with orphan drug status are of special interest for this development. In parallel with this work, early research work continues with the aim to identify new molecules that could potentially be developed for diseases outside the orphan drug status. This work is taking place in collaboration with Vicore Pharma’s research partner, Emeriti Bio.
Other activities
During the autumn, we have participated in a number of conferences, including NLS days in Malmö and the Pareto Health Care Conference in Stockholm, where we have presented the company for investors and pharmaceutical companies. In the future, we will participate in international pharma and investor conferences. We will also present at Erik Penser Bank’s company day in Stockholm on November 23 and at Stora Aktiedagen in Gothenburg on November 27th.
I look forward with confidence to the coming months, in which we will continue to make important steps for the development of C21 towards a new therapy for IPF. I hope you will will continue to follow and support us on this exciting journey. We’re looking forward to report our progress in upcoming reports.
Per Jansson, CEO
For further information, please contact:
Per Jansson, CEO
Tel: +46 709 17 47 46 or e-mail: per.jansson@vicorepharma.com
Hans Jeppsson, CFO
Tel: +46 705 53 14 65 or e-mail: hans.jeppsson@vicorepharma.com
This information is information that Vicore Pharma Holding 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 person set out above, at 08.00 CET on October 19, 2017