Year-end report 2019

Gothenburg, February 28 2020 - Vicore Pharma Holding AB (publ) publishes the year-end report for 2019. 

Important events during the fourth quarter

• In October, Vicore Pharma submitted an application to start a phase II study with C21 on cold induced vasoconstriction in subjects with systemic sclerosis (SSc). The application was approved and the first patient was recruited in December.  The study is expected to be completed within one year.
• In November, Vicore completed a directed share issue resulting in the proceeds of 125 MSEK before transaction costs.

Important events after the period

• In January, Vicore issued 243,525 shares to the warrant holders within the framework of the incentive programme LTIP 2016.
• In the VP01 program, the phase II study with C21 in patients with SSc has dosed its first patients.
• In the VP01 program, the first phase II study with C21 in patients with idiopathic pulmonary fibrosis (IPF) has been re-designed and extended to six months, compared to the earlier planned three months, in order to increase the probability of documenting a treatment effect. This will be enabled by comparing the development of the patients’ lung function with the well documented spontaneous disease progression. The study will not include a placebo group.

Financial overview for the period
October 1 – December 31 2019

• Net sales amounted to 0.0 MSEK (0.1)
• The operating loss was -30.2 MSEK (-13.6)
• Loss for the period amounted to -27.6 MSEK (-13.7)
• Loss per share, before and after dilution, was -0.60 SEK (-0.42)

Financial overview for the period
January 1 – December 31 2019

• Net sales amounted to 0.0 MSEK (0.5)
• The operating loss was -94.0 MSEK (-41.6)
• Loss for the period amounted to -93.1 MSEK (-21.7)
• Loss per share, before and after dilution, was -2.16 SEK (-0.95)
• On December 31, 2019, cash and cash equivalents amounted to 187.6 MSEK (224.7)
• On December 31, 2019, short-term investments amounted to 77.0 MSEK (0)
• The Board of Directors proposes to the Annual General Meeting that no dividend should be paid for the financial year 2019

Financial summary of the group

CEO comments

2019 was a busy year in which we took a number of significant steps towards the overall goal of developing Vicore into a company with an attractive portfolio of drugs for the treatment of unusual lung diseases such as idiopathic pulmonary fibrosis (IPF) and other diseases that match the specific characteristics of our drug candidates.

During the fourth quarter and the beginning of 2020, we had an intense focus on our phase II studies within the VP01 project. The study of blood flow in the hands of SSc patients with Raynaud’s phenomenon has started to recruit according to plan and the first patient has been dosed with C21. We expect that we will have topline data by the end of the year. The objective is to investigate the effect of C21 on cold-induced vessel contraction in people with SSc. This means that we can document a potential direct vasodilatory effect of C21 in humans, which can be of great importance for the vascular mechanism of C21 in SSc and IPF.

The IPF study design has been modified in order to 1) give us a stronger statistical power to detect a treatment effect; 2) give us better prerequisites for patient recruitment and 3) reduce the number of patients needed, hence potentially shortening the time to read-out. Instead of a blinded placebo-controlled three months study, which our safety package automatically allows for, we will conduct a six months study and compare to each patient’s well documented baseline values. This is feasible since the important endpoint, FVC, a measurement of lung volume, is an objective measure and because disease progression has consistently been documented to correspond to a decrease of lung volume of approximately 120 ml per six months. By doing this change, we also benefit from eliminating the risk of unintentional unblinding, since patients may realize whether they are on drug or placebo during the course of the study. We are currently in the process of finalizing the clinical trial application.

In November, we successfully completed a share issue of approximately SEK 125 million directed to Swedish and foreign institutions. The discount to the stock price was only 1.5 per cent, which reflected the great interest in participating among both existing and new institutional owners. Through the proceeds we strengthened our balance sheet significantly, which allows us to accelerate the pace of our development programs and thus potentially minimizing the time it takes to reach the market.

Another significant milestone in 2019 was the listing on Nasdaq Stockholm’s main market at the end of September. It represents a cornerstone to further increase the interest in Vicore and our share in the longer term.

The VP02 program, which concerns the local delivery of an IMiD to the lung for the treatment of IPF and IPF related cough, is proceeding according to plan. A product candidate that shows promising separation between local and systemic exposure is now being further explored in toxicological studies. The regulatory application in connection with the first clinical study within the VP02 program is planned for late 2020.

As of the fourth quarter of 2019, we changed our reporting to a functional break down in the income statement instead of a cost-specific structure. This provides a more accurate picture of our operations since the significant costs for clinical studies and R&D personnel are made more visible.

In summary, we enter 2020 at an excellent starting point: a world-class team, a strong balance sheet and a high pace in our drug development projects. Our focus is to create the best possible odds for our drug candidates to reach the market and thereby help severely suffering lung patients.

Carl-Johan Dalsgaard, CEO

The full interim report is available at: https://vicorepharma.com/investors/financial-reports/

For further information, please contact:

Carl-Johan Dalsgaard, CEO, tel: +46 (0)70 975 98 63, carl-johan.dalsgaard@vicorepharma.com

This information was submitted for publication on February 28 2020 at 08:00 CET.

About Vicore Pharma Holding AB (publ)
Vicore Pharma is a Swedish rare disease pharmaceutical company focused on interstitial lung diseases and related indications. The company currently has two drug development programs, VP01 and VP02. 

VP01 aims to develop the substance C21 for the treatment of idiopathic pulmonary fibrosis (“IPF”) and systemic sclerosis (“SSc”). VP02 is based on a new formulation and delivery route of an existing immunomodulatory compound (an “IMiD”). VP02 focuses on the underlying disease and the severe cough associated with IPF. VP01 and VP02 are also being actively evaluated for other indications within the field of interstitial lung diseases which have a significant high unmet need. 

The company's shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.

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