Year-end report 2017

SUMMARY OF THE PERIOD 

Important events during the fourth quarter 2017

• In December, Vicore Pharma Holding increased its holding in I-Tech AB through a share issue.
• In December, Vicore Pharma submitted an application to the British authorities to start a phase IIa study in patients suffering from idiopathic pulmonary fibrosis (IPF).
• In December, Vicore Pharma’s board member, Göran Arvidson, passed away.
• In October, Vicore Pharma announced results from the in-depth analysis of the Phase I extension study. The results verified previously published data that C21 has beneficial effects on lipid metabolism. It is a first demonstration of pharmacodynamic effects in man for C21 and indeed for the pharmacological principle of AT2 receptor stimulation

Important events after the period

• In February, Vicore Pharma Holding increased its holding in I-Tech AB by acquiring shares from an existing shareholder in I-Tech. Thereafter, Vicore Pharma Holding owns 26.5% of the shares in I-Tech.

Financial summary 

CEO COMMENTS

Fourth quarter: Application for phase IIa study submitted
In December, Vicore Pharma submitted an application to start a phase IIa study with C21 in our lead indication, idiopathic pulmonary fibrosis (IPF). The application was prepared together with our CRO (Contract Research Organisation), PAREXEL. This is an important step for us and we look forward to start the study as soon as the necessary approvals are at hand.

Summary of 2017
As previously communicated, we updated our strategy during the autumn 2017. We are now focused on developing C21 for fibrotic diseases with orphan drug designation. Based on the underlying data we have generated over the years, we have selected idiopathic pulmonary fibrosis (IPF) as the first indication in which to start a phase IIa study. During the spring 2017, when we conducted a BioMAP® study with the purpose to investigate the anti-fibrotic properties for C21 in human cells. BioMAP is a screening study where human lung cells are exposed to fibrosing compounds whereafter these cells can be used to evaluate possible effects in test substances. Data from the study confirms that C21 exerts its positive antifibrotic effects in primary human cells, further giving strength to the well documented antifibrotic effects already demonstrated in fibrotic animal models. C21 exerted stronger anti-inflammatory and antifibrotic effects compared to the two approved IPF drugs. In January 2017, Vicore Pharma was granted orphan drug designation for C21 from the FDA in the USA. C21 holds the corresponding orphan drug status in the EU since 2016.

As part of the continued development and entering a new clinical phase, we strengthened our organisation during the summer with three key recruitments: Kicki Johansson as Head of Drug Development; Hans Jeppsson as CFO; and Ulrike Muscha Steckelings as CSO.

We were saddened to receive the news of the passing in December of our board member, Göran Arvidson. The nomination committee intend to seek a successor to the next AGM in May 2018.

To strengthen our capital position, Vicore Pharma Holding gained 56 MSEK during the spring from two directed share issues to institutional Swedish and international investors.

Associate company, I-Tech
In December, Vicore Pharma Holding increased its holding in I-Tech AB to 21% through a share issue. After the period, in February, Vicore Pharma Holding and the majority of the shareholders in I-Tech, in accordance to the company’s pre-emption rights further increased our holding  by acquiring shares from a long-standing shareholder in I-Tech. Our holding in I-Tech is now 26.5%.  I-Tech is now an associate company and is accounted for in the group accounts in accordance with the equity method. This means there is a negative effect of 13,6 MSEK on our profit for the period.

I-Tech has developed Selektope®, an approved bio-repellent substance that protects boat and ship hulls from barnacle settlement. Selektope® is used as a strategic biocide in antifouling coatings. Selektope® is sold to companies that manufacture marine coatings for commercial shipbuilding and repair. There are currently 6 registered marine coatings containing Selektope on the market in Asia.

I-Tech has had an eventful 2017. The company has gained a new customer in coating company, Hempel, which has launched an outfitting coating containing Selektope®. Another existing customer, Chugoku Marine Paints, has  extended its product range during 2017 with another product containing Selektope®. A Swedish shipping company, Stena RoRo, signed a contract to coat the hulls of four newbuild ferries with a Selektope®-based coating. High demand for Selektope® has led to I-Tech signing agreements with import agents in Japan to strengthen our supply chains. During the year, I-Tech has made new recruitments to bring onboard new skills adapted to the excting growth phase the company is currently in.

The significant progress made during 2017, which paves the way for further positive development of I-Tech, was the key factor in Vicore Pharma Holding’s decision to participate in the share issue I-Tech conducted at the end of 2017, and to then later also acquire shares from an existing shareholder in I-Tech.

Looking to the future
During 2018, together with our CRO, our focus will be to initiate the phase IIa IPF study. More details on the implemention of the study will be communicated during the spring. We continue to work with qualified researchers, clinicians and specialists in drug development to select a second indication to develop. 

We sincerely thank all our shareholders for their support during the past year. We look forward to continuing to build more value for Vicore Pharma Holding!

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 February 21, 2018

About Vicore Pharma Holding
Vicore Pharma develops drugs that act through the AT2 receptor. The company’s drug candidate C21 aims to improve the treatment of idiopathic pulmonary fibrosis, a rare disease for which C21 has been granted orphan drug designation both in the EU and the US. In addition, C21 is explored pre-clinically in a number of rare diseases where the AT2 receptor plays an important role. Vicore Pharma is based in Astra Zeneca's Bioventurehub in Mölndal. The company's share (VICO) is listed for trading on Nasdaq First North in Stockholm with Erik Penser Bank as Certified Adviser. For more information, see  www.vicorepharma.com