Interim report April-June 2020

2020-08-26 | Regulatory

Gothenburg, August 26, 2020 – Vicore Pharma Holding AB (publ) publishes the interim report for the second quarter 2020.

Important events during the second quarter

  • In April, Vicore Pharma gained approval from the UK regulatory agency MHRA, to start the phase II study with VP01 on patients with COVID-19. The ATTRACT study is a randomized, double blind, placebo controlled study in approximately 100 COVID-19 patients with a moderately severe disease, treated with basic respiratory care, but not on mechanical ventilation. The study will investigate the efficacy on respiratory failure and functional outcomes.
  • In May, Vicore Pharma received approval from the UK regulatory agency MHRA, to start the phase II study with VP01 in patients with idiopathic pulmonary fibrosis (IPF).
  • In May, Vicore Pharma was awarded a grant of 1.5 GBP million from the UK charity LifeArc for the  ATTRACT study in patients with COVID-19.
  • In June, Vicore Pharma announced positive results with VP01 in a preclinical model considered predictive of human pulmonary hypertension.
  • In June, Vicore Pharma announced that the ATTRACT study with VP01 on COVID-19 will expand to India in order to accelerate patient enrolment. A clinical trial application has been submitted and approved by the health authorities in India.

Important events after the period

  • In July, Vicore completed a directed share issue resulting in proceeds of 185 MSEK before
    transaction costs. Pro forma, including the directed share issue, cash and cash equivalents and short-term investments per June 30, 2020, amounted to 397.4 MSEK.
  • In July, Vicore Pharma announced that the first patient with COVID-19 has been dosed in the ATTRACT study in India.
  • In August, Vicore Pharma announced that the study with VP01 in patients with systemic sclerosis had restarted after the pause caused by the COVID-19 pandemic.

Financial overview for the period

April 1 – June 30, 2020

  • Net sales amounted to 0.0 MSEK (0.0)
  • The operating loss was -27.5 MSEK (-24.8)
  • Loss for the period amounted to -24.2 MSEK (-26.6)
  • Loss per share, before and after dilution, was -0.48 SEK (-0.63)
  • On June 30, 2020, cash and cash equivalents and short-term investments amounted to 212.4 MSEK (264.6 MSEK as of December 31, 2019)

January 1 – June 30, 2020

  • Net sales amounted to 0.0 MSEK (0.0)
  • The operating loss was -56.3 MSEK (-40.9)
  • Loss for the period amounted to -52.6 MSEK (-42.6)
  • Loss per share, before and after dilution, was -1.04 SEK (-1.02)

Financial summary of the group

Amounts in MSEK 2020
Apr-Jun
2019
Apr-Jun
2020
Jan-Jun
2019
Jan-Jun
2019
Jan-Dec
Net sales 0.0 0.0 0.0 0.0 0.0
Operating loss -27.5 -24.8 -56.3 -40.9 -94.0
Loss for the period -24.2 -26.6 -52.6 -42.6 -93.1
Loss per share, before/after dilution (SEK)1 -0.48 -0.63 -1.04 -1.02 -2.16
Research- and development costs/
operating costs (%)
85.4 73.1 84.6 64.4 71.3
Equity at the end of the period 272.7 253.7 272.7 253.7 321.6
Cash flow from operating activities -25.8 -22.4 -55.1 -40.9 -87.0
Cash and cash equivalents and short-term
investments at the end of the period
212.4 193.5 212.4 193.5 264.6

1 There is no dilution effect for potential ordinary shares for periods where earnings have been negative.

CEO Comments

The second quarter was intense with setting up the phase II VP01 studies ATTRACT (COVID-19) and the IPF study. We also had several investor meetings leading up to a capital raise on July 2, reducing the financial risks and expectedly extending the runway well beyond the readout of the phase II study in IPF.

The ATTRACT study expands to recruit outside the UK

ATTRACT (Angiotensin II Type Two Receptor Agonist COVID-19 Trial) is targeting hospitalized patients treated with basic respiratory care, but not on mechanical ventilation. These patients have a marked inflammatory drive which can lead to acute respiratory failure if it progresses.

At the end of April, we announced approval of the clinical trial application (CTA) from the UK regulatory agency MHRA in record time and we have now full regulatory approval in the UK. In June, the number of cases in the UK was going down and in order to accelerate recruitment we performed a thorough feasibility study in countries outside the UK and decided to file also in India, where the number of cases is still on the rise. The CTA was approved in mid-June and at the end of July, the first patient was dosed. Although predictions of COVID-19 in India are extremely difficult we expect the study to be completed by year end.

In strong competition, the ATTRACT study was awarded a grant from the UK charity LifeArc of approximately 1.5 GBP million (18.5 MSEK) after prioritization by an expert panel.

The IPF study approved in the UK

The IPF study is a multi-center, open-label, single-arm trial investigating the safety, efficacy, and pharmacokinetics of VP01 in subjects with IPF. It was approved by the UK regulatory agency MHRA in May and pending the development of COVID-19 the company still expects the study to start late Q3. However, to make sure that we do not depend on a single country, feasibility studies have been performed in other countries and also for this study a clinical trial application has been submitted to the Indian authorities as the first country outside of the UK. The study will include approximately 60 patients and the observed treatment effect of VP01 for six months will be compared with the well-documented linear decline of lung function in untreated patients.

The SSC study has started again and is still on track

In the mechanistic study in patients with systemic sclerosis (SSc) and Raynaud's phenomena, the effect of VP01 on blood flow in small vessels is investigated. This will, together with the elaborate animal model of pulmonary hypertension, determine the effect on vasculopathy. The recruitment to this study was ahead of schedule when we needed to pause due to COVID-19. It has now started again and if the COVID-19 situation does not change, we expect the study to be completed  by the end of the year.

Intriguing data from an animal model of pulmonary hypertension

In the gold-standard preclinical model, considered predictive of human pulmonary hypertension, the so called Sugen-hypoxia model, VP01 demonstrated both hemodynamic effects and reduced vascular remodeling. This together with the anti-fibrotic effects give VP01 a unique profile.

The VP02 program starts tech transfer for clinical (GMP) production

The inhaled formulation for local delivery of an IMiD to treat IPF-related cough, is in a preclinical development phase, finetuning the formulation and preparing for the toxicological studies. In order to manufacture the product for the first clinical trial, the company has entered an agreement with Nanologica AB for tech transfer to the UK manufacturer Sterling Ltd.

The VP03 program advances

In the VP01 follow up project, two classes of novel and unique compounds have been identified and patent applications filed. One of these compounds is now progressing to toxicological studies.

Successful capital raise

In early July, we successfully completed a share issue of approximately 185 MSEK directed to Swedish and foreign institutions. Once again, we received a significant interest from specialized and long-term investors, both existing and new. Through the proceeds we strengthened our balance sheet significantly, which reduces the financial risks in the company and allows us to accelerate the pace of our programs, not least the development of VP03.

To summarize, we are now prepared to have three phase II studies up and running during the second half of 2020 and have a healthy financial position.

Carl-Johan Dalsgaard, CEO

 

For further information, please contact:

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

Hans Jeppsson, CFO, tel: +46 70 553 14 65, hans.jeppsson@vicorepharma.com

 

This information was submitted for publication on 26 August 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.