Year-end report 2019

2020-02-28 | Regulatory

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

Amounts in MSEK 2019
Oct-Dec
2018 Oct-Dec 2019 Jan-Dec 2018 Jan-Dec
Net sales 0.0 0.1 0.0 0.5
Operating loss -30.2 -13.6 -94.0 -41.6
Loss for the period -27.6 -13.7 -93.1 -21.7
Loss per share, before/after dilution (SEK) -0.60 -0.42 -2.16 -0.95
Equity at the end of the period 321.6 285.4 321.6 285.4
Cash flow from operating activities -24.8 -25.6 -87.0 -33.0
Cash and cash equivalents at the end of the period 187.6 224.7 187.6 224.7
Short-term investments  at the end of the period 77.0 0.0 77.0 0.0

 

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.

Vicorepharma

On vicorepharma.com, we use so-called cookies to analyze how our website is used in order to optimize and improve it. You choose yourself whether you want to consent to our use of cookies.

Vicorepharma is responsible for placing cookies on the website and for the processing of your personal data collected by them. For more information about our processing of your personal data, see our privacy policy

Cookie policy

Your consent applies to the following domain: vicorepharma.com
The cookie policy was last updated: 2023-06-29

Privacy Policy

Show the cookies used on our website

Necessary cookies is needed in order for the website's basic functions to work correctly and for us to be able to save your choice of cookies.

  • cookies_set

    Purpose: Saves the visitor’s choice of cookies.
    Issued by: mk cookie master
    Lifespan: 1 year

    Domain: vicorepharma.com

  • selected_cookies

    Purpose: Saves the visitor’s choice of cookies.
    Issued by: mk cookie master
    Lifespan: 1 year

    Domain: vicorepharma.com

Statistical cookies helps the website owners to understand how visitors interact with the website by collecting and report this information.

  • _ga

    Purpose: Used to understand how visitors’ navigate around the website.
    Issued by: Google Analytics
    Lifespan: 2 years

    Domain: vicorepharma.com

  • _gat

    Purpose: Used to throttle request rate. If Google Analytics is deployed via Google Tag Manager, this cookie will be named _dc_gtm_.
    Issued by: Google Analytics
    Lifespan: 1 minute

    Domain: vicorepharma.com

  • _gid

    Purpose: Used to understand how visitors’ navigate around the website.
    Issued by: Google Analytics
    Lifespan: 1 day

    Domain: vicorepharma.com

 

What are cookies?

A cookie is a small text file that is placed on your device (computer/mobile/tablet that has access to the internet) by the website you visit – if you give your consent to this. The cookie can, for example, recognize you as a user when you visit our website and make it possible to remember important information that makes your visit more comfortable and provides an improved user experience. Cookies are so-called passive files that cannot spread dangerous software or viruses on your mobile device or computer.

There are two types of cookies, permanent cookies and session cookies. At vicorepharma.com we use both permanent cookies and session cookies. Permanent cookies are saved as a file on the computer for a certain time until the server that placed them, or you as a visitor choose to delete them. Session cookies are temporarily stored when you as a visitor are on the website and disappear when you close your browser.

Cookies can also be divided into first-party cookies and third-party cookies. First-party cookies are placed by the website you are visiting, while third-party cookies are placed by another website. At vicorepharma.com, we use both first-party cookies and third-party cookies.

 

How to avoid cookies

When you visit our website, you can refuse all or certain types of cookies. You can also withdraw or change your consent at any time by clicking here.

You can also block cookies by changing the settings in your browser. Then your browser will automatically refuse cookies or inform you when a website requests to store cookies.

After your visit, you can review and delete the permanent cookies that have been stored in your browser. In the list below, you will see the name of the cookies vicorepharma.com saves so that you can easily identify them.

Here you will find more information about how to manage cookies in your browser:

 

Cookies used by third parties

On vicorepharma.com there may be content that is embedded from YouTube. YouTube places cookies in your browser when you visit youtube.com or when you click on embedded content from YouTube on our website. vicorepharma cannot control these cookies or the personal data and information that may be collected. vicorepharma does not use the targeted marketing services offered by YouTube. As a user, you therefore need to check YouTube’s website for further information on how they manage cookies, what information they collect and how you can delete any third-party cookies.

 

Cookies used on vicorepharma.com

Necessary cookies is needed in order for the website's basic functions to work correctly and for us to be able to save your choice of cookies.

  • cookies_set

    Purpose: Saves the visitor’s choice of cookies.
    Issued by: mk cookie master
    Lifespan: 1 year

    Domain: vicorepharma.com

  • selected_cookies

    Purpose: Saves the visitor’s choice of cookies.
    Issued by: mk cookie master
    Lifespan: 1 year

    Domain: vicorepharma.com

Statistical cookies helps the website owners to understand how visitors interact with the website by collecting and report this information.

  • _ga

    Purpose: Used to understand how visitors’ navigate around the website.
    Issued by: Google Analytics
    Lifespan: 2 years

    Domain: vicorepharma.com

  • _gat

    Purpose: Used to throttle request rate. If Google Analytics is deployed via Google Tag Manager, this cookie will be named _dc_gtm_.
    Issued by: Google Analytics
    Lifespan: 1 minute

    Domain: vicorepharma.com

  • _gid

    Purpose: Used to understand how visitors’ navigate around the website.
    Issued by: Google Analytics
    Lifespan: 1 day

    Domain: vicorepharma.com

General

Vicore Pharma Holding AB (“Vicore”) shall only process personal data in accordance with applicable data protection law and high industry standards.

 

Personal data.

Vicore processes personal data provided to us;
(i) by you in the day-to-day communications, or

(ii) in connection with entering into or performing an agreement or business arrangement with you, or
(iii) by a third party allowed by law or your consent.

The personal data may consist of contact and identification details and other information relevant to the situation.

 

Purpose.

Vicore process personal data for the purpose of communicating with you and to perform, manage and comply with agreements between us as well as rights and obligations which are allowed by law or applicable regulation.

 

Legal grounds.

The legal grounds for processing personal data is either;
(i) your consent which shall be considered provided when you either voluntary submit the personal data or enter into an agreement with us, or
(ii) a legitimate interest allowed under law.

 

Security

Vicore shall use adequate technical and organisational security measures to protect the personal data from loss and to safeguard against access from unauthorised persons.

Transfers of personal data may only occur;
(i) to third parties who perform services on Vicore behalf and who may only process personal data in accordance with our instructions, and may not use personal data for their own purposes; and
(ii) outside the EU/EEA only in accordance with applicable data protection laws and subject to the EU Commission’s standard contractual clauses, and
(iii) as otherwise permitted by law or your consent.

Duration.

The duration we process personal data is limited to what is reasonable for the purpose of the processing, unless otherwise required or permitted by law.

 

Rights

Vicore is the controller of the personal data processing, meaning that we are responsible for that the personal data is processed correctly and in accordance with applicable data protection laws.

Unless prevented by applicable law, regulation or agreement data subjects have the right to;
(i) know what personal data we process about them,
(ii) request that we rectify or erase inaccurate or incomplete personal data
(iii) object to specific processing of personal data, and
(iv) receive the personal data provided by them and have the personal data transferred to another party responsible for data processing.

All communications with Vicore regarding how we process personal data or exercise of any of your rights can be sent by e-mail to info@vicorepharma.com or by post to the address above.

Reports and complaints can also be directed to Datainspektionen who is the supervisory authority for our processing of personal data.