Interim report July – September 2021

2021-11-04 | Regulatory

Gothenburg, November 4, 2021 – Vicore Pharma Holding AB (publ) publishes the interim report for the third quarter 2021.

Important events during the third quarter

  • In August, Vicore announced a strenghtened management team with three senior recruitments; Jessica Shull, Head of Digital Therapeutics, Åsa Magnusson, Chief Commercial Officer and Mikael Nygård, VP Business Development.
  • In September, Vicore announced that the first patients in the global phase 3 trial with C21 in COVID-19 (ATTRACT-3) were dosed.
  • In September, Vicore announced that the company was granted a patent in the US covering the use of C21 to treat infections caused by Severe Acute Respiratory Syndrome (SARS) coronavirus (CoV), including SARS CoV-2.

Important events after the period

  • In October, Vicore announced that the results from the phase 2 trial in COVID-19 (ATTRACT) were published in EClinicalMedicine, a scientific journal published by the Lancet.
  • In November, Vicore announced results from the ATTRACT phase 2 extension trial showing that C21 reduced long-term lung injury after COVID-19.

Financial overview for the period

July 1 – September 30, 2021

  • Net sales amounted to 0.0 MSEK (0.0)
  • The operating loss was -97.8 MSEK (-34.4)
  • Loss for the period amounted to -97.6 MSEK (-36.0)
  • Loss per share, before and after dilution, was -1.36 SEK (-0.65)
  • On September 30, 2021, cash and cash equivalents and short-term investments amounted to 446.9 MSEK (318.7 MSEK as of December 31, 2020)

January 1 – September 30, 2021

  • Net sales amounted to 0.0 MSEK (0.0)
  • The operating loss was -213.7 MSEK (-90.7)
  • Loss for the period amounted to -216.1 MSEK (-88.6)
  • Loss per share, before and after dilution, was -3.13 SEK (-1.70)

Financial summary of the group

Amounts in MSEK 2021
Jul-Sep
2020
Jul-Sep
2021
Jan-Sep
2020
Jan-Sep
2020
Jan-Dec
Net sales 0.0 0.0 0.0 0.0 0.0
Operating loss -97.8 -34.4 -213.7 -90.7 -149.5
Loss for the period -97.6 -36.0 -216.1 -88.6 -146.9
Loss per share, before/after dilution (SEK)1 -1.36 -0.65 -3.13 -1.70 -2.71
Research  and development costs/
operating costs (%)2
93.5 85.2 92.2 84.8 84.7
Equity at the end of the period 462.6 412.0 462.6 412.0 354.5
Cash flow from operating activities -68.4 -25.7 -189.9 -80.8 -119.9
Cash and cash equivalents and short-term
investments at the end of the period
446.9 361.4 446.9 361.4 318.7

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

2 Alternative performance measure (APM). Defined on page 21 in the interim report.

CEO Comments

Vicore made significant progress during the third quarter of 2021 in the clinic, in preclinical studies and in building its patent estate. The company stands at the threshold of a new phase.

The company is expanding in many ways. In August, we welcomed both Åsa Magnusson as Chief Commercial Officer and Mikael Nygård as VP of Business Development. They join a strengthened Vicore management team along with Jessica Shull, our Head of Digital Therapeutics who joined the company in May 2021.

Our clinical programs are gaining momentum. In September, the first patients were recruited to Vicore’s ATTRACT-3, phase 3, multinational, multi-centre placebo-controlled pivotal study in COVID-19. Vicore has so far activated clinical trial sites in the US, Czech Republic, Ukraine, South Africa, India and Philippines.

The commercial value of ATTRACT-3 to Vicore was strengthened in September when the U.S. Patent and Trademark Office granted the company a patent covering the use of C21 for treating all SARS coronavirus infections. Vicore now has patent protection in the US market until December 2040 for C21 as a symptomatic treatment improving lung function for SARS-CoV-2, including any variants that arise in the present pandemic and any newly emergent SARS coronaviruses that underlie future diseases.

After the completion of the quarter, Lancet’s EClinicalMedicine, a peer-reviewed journal, published the full results of the phase 2 clinical trial, ATTRACT, that preceded the ATTRACT-3 study. The study showed how a 7-day treatment with C21 significantly reduced the proportion of patients requiring supplemental oxygen and aided faster patient recovery.

In November, we published the results from the extension trial, ATTRACT-2, where C21 continues to present good effects, 3-6 months after end of treatment. The results show nearly 50% reduction in lung injury in the C21 group compared to the placebo group, further strengthening evidence that C21 can accelerate recovery after COVID-19.

There have been further exciting developments in Vicore’s key clinical indication of Idiopathic Pulmonary Fibrosis (IPF). The first patients have completed treatment in the ongoing multinational, open-label phase 2 clinical trial with C21, the AIR study. AIR is on track for read-out in Q4 2022, with clinical centres activated in all the countries involved in what has been described by clinical experts as a patient-friendly clinical trial, easy to recruit.

Vicore’s other programs encompassing our ‘suite of products’ for IPF are also on track. The company expects to start a GLP toxicology study with VP02, the inhaled thalidomide product for IPF and IPF cough, by the end of 2021. Vicore’s proprietary digital therapeutic, VP04, designed as a channel for cognitive behavioural therapy for patients suffering from IPF will enter clinical studies during Q2, 2022. VP03, our C21 follow-on program, is expected to enter into the clinic during H1 2022, we will provide details in the near future. The new molecule is a modulator of AT2R – the target on which C21 acts. AT2R is the inducible arm of the Renin-Angiotensin-System (RAS), an unexploited regenerative biological system with great potential for pharmaceutical development in a wide range of disease areas. Our C21 R&D programs have provided Vicore with an understanding of the biology of the receptor and the physiological consequences of targeting it. With C21 in clinical trials, we have shown that AT2R is druggable and have established broad intellectual property protection around the class of AT2R stimulating drugs.

As we enter this new and expansive phase, I would like to thank our growing group of employees, participants in our clinical trials, our clinical collaborators around the world and our shareholders for their continued support of Vicore’s work.

Carl-Johan Dalsgaard

Interim report July-September, 2021; https://vicorepharma.com/investors/financial-reports/

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 November 4, 2021 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: 2023-01-24

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

Marketing cookies is used to track visitors on the website. The intention is to show ads that are relevant and engaging to the individual user and thus be more valuable to publishers and third-party advertisers.

  • AMP_TOKEN

    Purpose: Contains a token that can be used to retrieve a unique user ID.
    Issued by: AMP
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _fbp

    Purpose: Used to store and track visits across websites.
    Issued by: Facebook
    Lifespan: 3 months

    Domain: vicorepharma.com

  • _gac_

    Purpose: Used to store and track audience reach.
    Issued by: Google Ads
    Lifespan: 90 days

    Domain: vicorepharma.com

  • _lfa

    Purpose: Used to store and track audience reach.
    Issued by: Leadfeeder
    Lifespan: 2 years

    Domain: vicorepharma.com

  • _lfa_test_cookie_stored

    Purpose: Used to test if _lfa was stored.
    Issued by: Leadfeeder
    Lifespan: 1 day

    Domain: vicorepharma.com

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

  • _clck

    Purpose: Used to store a unique user ID.
    Issued by: Microsoft Clarity
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _clsk

    Purpose: Used to store and combine pageviews by a user into a single session recording.
    Issued by: Microsoft Clarity
    Lifespan: 1 day

    Domain: vicorepharma.com

  • _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

  • _hjAbsoluteSessionInProgress

    Purpose: Used to store unique visits.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjFirstSeen

    Purpose: Used to identify a new visitors’ first session.
    Issued by: Hotjar
    Lifespan: Session

    Domain: vicorepharma.com

  • _hjid

    Purpose: Used to store a unique user ID.
    Issued by: Hotjar
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _hjIncludedInPageviewSample

    Purpose: Used to check if the visitor is included in the data sample defined by the site’s daily pageview limit.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjIncludedInSessionSample

    Purpose: Used to check if the visitor is included in the data sample defined by the site’s daily session limit.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjSessionUser{site_id}

    Purpose: Used to store a unique user ID.
    Issued by: Hotjar
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _hjSession{site_id}

    Purpose: A cookie that holds the current session data.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjTLDTest

    Purpose: Used to check if cookies can be loaded on the site and is removed shortly afterward.
    Issued by: Hotjar
    Lifespan: Session

    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.

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

Marketing cookies is used to track visitors on the website. The intention is to show ads that are relevant and engaging to the individual user and thus be more valuable to publishers and third-party advertisers.

  • AMP_TOKEN

    Purpose: Contains a token that can be used to retrieve a unique user ID.
    Issued by: AMP
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _fbp

    Purpose: Used to store and track visits across websites.
    Issued by: Facebook
    Lifespan: 3 months

    Domain: vicorepharma.com

  • _gac_

    Purpose: Used to store and track audience reach.
    Issued by: Google Ads
    Lifespan: 90 days

    Domain: vicorepharma.com

  • _lfa

    Purpose: Used to store and track audience reach.
    Issued by: Leadfeeder
    Lifespan: 2 years

    Domain: vicorepharma.com

  • _lfa_test_cookie_stored

    Purpose: Used to test if _lfa was stored.
    Issued by: Leadfeeder
    Lifespan: 1 day

    Domain: vicorepharma.com

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

  • _clck

    Purpose: Used to store a unique user ID.
    Issued by: Microsoft Clarity
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _clsk

    Purpose: Used to store and combine pageviews by a user into a single session recording.
    Issued by: Microsoft Clarity
    Lifespan: 1 day

    Domain: vicorepharma.com

  • _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

  • _hjAbsoluteSessionInProgress

    Purpose: Used to store unique visits.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjFirstSeen

    Purpose: Used to identify a new visitors’ first session.
    Issued by: Hotjar
    Lifespan: Session

    Domain: vicorepharma.com

  • _hjid

    Purpose: Used to store a unique user ID.
    Issued by: Hotjar
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _hjIncludedInPageviewSample

    Purpose: Used to check if the visitor is included in the data sample defined by the site’s daily pageview limit.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjIncludedInSessionSample

    Purpose: Used to check if the visitor is included in the data sample defined by the site’s daily session limit.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjSessionUser{site_id}

    Purpose: Used to store a unique user ID.
    Issued by: Hotjar
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _hjSession{site_id}

    Purpose: A cookie that holds the current session data.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjTLDTest

    Purpose: Used to check if cookies can be loaded on the site and is removed shortly afterward.
    Issued by: Hotjar
    Lifespan: Session

    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.