Interim report April – June 2022

2022-08-25 | Regulatory

Gothenburg, August 25, 2022 – Vicore Pharma Holding AB (publ) publishes the interim report for the second quarter 2022.

Important events during the second quarter

  • In April, Vicore announced that the first patient in the clinical investigation of the digital therapeutic (DTx) in IPF was enrolled.
  • In April, Vicore submitted a clinical trial application (CTA) to start a phase 1 trial with the new drug candidate (C106) from the VP03 program.
  • In June, Vicore announced an amendment of the primary endpoint to all-cause mortality and a reduced sample size in the phase 3 trial in COVID-19. Read-out is expected during Q3 2022.
  • In June, Vicore announced that the first subject was dosed in the phase 1 trial with C106.
  • In June, Vicore resolved on a set-off issue of 87,686 shares and a total of 3 MSEK in cash as part of a milestone compensation to Emeriti Bio and HaLaCore for the start of the phase 1 trial with C106.

Important events after the period

  • In August, Vicore announced that the IPF interim data was selected as an oral late breaker at the ERS congress.

Financial overview for the period
April 1 – June 30, 2022

  • Net sales amounted to 0.0 MSEK (0.0)
  • The operating loss was -64.9 MSEK (-68.4)
  • Loss for the period amounted to -65.9 MSEK (-70.4)
  • Loss per share, before and after dilution, was -0.92 SEK (-0.98)
  • On June 30, 2022, cash, cash equivalents and short-term investments amounted to 236.6 MSEK (371.5 MSEK as of December 31, 2021)

January 1 – June 30, 2022      

  • Net sales amounted to 0.0 MSEK (0.0)
  • The operating loss was -158.0 MSEK (-116.0)
  • Loss for the period amounted to -159.2 MSEK (-118.5)
  • Loss per share, before and after dilution, was -2.22 SEK (-1.75)

Financial summary of the group

Amounts in MSEK 2022
Apr-Jun
2021
Apr-Jun
2022
Jan-Jun
2021
Jan-Jun
2020
Jan-Dec
Net sales 0.0 0.0 0.0 0.0 0,0
Operating loss -64.9 -68.4 -158.0 -116.0 -294.8
Loss for the period -65.9 -70.4 -159.2 -118.5 -296.5
Loss per share, before/after dilution (SEK)1 -0.92 -0.98 -2.22 -1.75 -4.25
Research  and development costs/
operating costs (%)2
84.1 92.7 85.3 91.1 91.9
Equity at the end of the period 228.1 559.2 228.1 559.2 383.3
Cash flow from operating activities -61.3 -73.8 -132.9 -121.5 -265.2
Cash and cash equivalents and short-term
investments at the end of the period
236.6 514.4 236.6 514.4 371.5

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 20 in the interim report.

CEO Comments

The emergence of the next generation of ATRAGs (angiotensin II type 2 receptor agonists) is an important signal of the transformation that we are currently implementing at Vicore. The early clinical data of C21 not only open an avenue for pioneering ATRAGs in severe lung diseases such as IPF, but also act as a pathfinder for the ATRAGs, an entirely new class of drugs around which Vicore has accumulated highly valuable clinical experience, is pursuing significant intellectual property protection, all supported by a broad-ranging matrix of supporting technology.

In the second quarter of 2022, Vicore’s progress continued with the company leveraging its substantial body of clinical experience and knowledge accumulated through work on C21. This includes treatment of severe lung diseases and the development of angiotensin II type 2 receptor agonists (ATRAGs) across a broader range of conditions.

The company is currently anticipating several clinical milestones in the second half of 2022. As previously announced, Vicore has worked closely with international regulatory authorities to alter the design of its phase 3 ATTRACT-3 clinical trial of C21 in the treatment of COVID-19 that requires hospitalization. Both the company and regulators have responded nimbly to the evolving profile of the COVID-19 pandemic, changing the primary endpoint of the ATTRACT-3 trial to all-cause mortality. This clarifies the clinical analysis and broadens the way in which the impact of C21 for COVID-19 patients is measured. We also agreed with regulators that it would be possible to reduce the number of patients that we need to recruit for the trial to approximately 300, roughly half the number in the original design. We now expect a topline read-out from ATTRACT-3 in the third quarter of 2022, after which the company will determine the next steps for C21 in COVID-19.

Vicore is also anticipating further maturation of the phase 2 AIR trial with C21 in idiopathic pulmonary fibrosis (IPF) following the promising interim findings we announced in February 2022. That interim analysis showed that lung function increased by a clinically meaningful degree in a high proportion of C21-treated patients. Over the next few months, and in consultation with key opinion leaders in IPF, Vicore will undertake a deep evaluation of both clinical and other underlying data from the AIR trial as a key component in the planning of the next trial with C21 in IPF.

Alongside the excitement of the interim results from AIR and the planning of the next trial, Vicore has embarked on COMPANION, a clinical study of the impact of our digital cognitive behavioral therapeutic, AlmeeTM, in addressing the psychological symptom burden in adults diagnosed with severe fibrotic lung diseases, including IPF. The COMPANION study will take place in the US and will deploy cutting edge clinical approaches that allow patient inputs and assessments to be made on a highly decentralized basis. After a pilot phase that began in Q2 2022, COMPANION is now advancing towards the pivotal phase which is expected to conclude in 2023.

Our trials with C21 in COVID-19 and IPF have produced highly encouraging findings, indicating that an ATRAG like C21 can restore function to diseased lungs, whether the cause of the lung injury is long-term fibrosis or short-term viral infection. This success inspired another phase in Vicore’s progression, the expansion of our ATRAG program beyond C21 to a set of proprietary ‘next generation’ ATRAGs that the company will develop for other indications.

In June, we announced that the first healthy volunteer had been dosed with C106, the first angiotensin II type 2 receptor agonist from Vicore’s new molecule program (VP03) since C21. C106 is the first ATRAG to enter the clinic since C21 and its clinical debut triggered a part-cash, part-shares milestone payment to its collaborators Emeriti Bio and HaLaCore Pharma. Using methods Vicore has developed in-house, we know that C106 is highly specific with high AT2 receptor affinity and that it has anti-fibrotic activity at clinically relevant concentrations in human fibrotic lung and kidney tissue.

C106 and the other next generation ATRAGs approaching the clinic will become an increasingly important part of Vicore’s asset base over time. Each of them is an orally-available small molecule drug candidate with high affinity for the AT2 receptor with projected long-lasting intellectual property protection. C106, for instance, is expected to have patent protection until at least 2041.

The emergence of the next generation of ATRAGs is an important signal of the transformation that we are currently implementing at Vicore. The early clinical data of C21 not only open an avenue for pioneering ATRAGs in severe lung diseases such as IPF, they also act as a pathfinder for the ATRAGs, an entirely new class of drugs around which Vicore has accumulated highly valuable clinical experience, is pursuing significant intellectual property protection, all supported by a broad-ranging matrix of supporting technology. As a group, the ATRAGs have therapeutic potential well beyond rare disease. Vicore has shown that ATRAGs have the capacity to address tissue damage and reverse some functional losses in lung and kidney tissue. We anticipate that the maturation of the clinical studies of the company’s proprieatry molecules will define the scope and reach of Vicore’s ATRAG platform.

In short, during the second quarter, Vicore has continued to gain momentum as the company marches towards 2023. I want to express profound personal gratitude to the key opinion leaders who help guide the design and execution of our clinical trial programs. Similarly, we will continue to work closely with healthcare providers and funders throughout Europe and the United States as our exciting drug candidates attract attention on their way to the market. We will forge new relationships with clinical investigators and patients who honor us by joining our expanding clinical trials program. As we enter the second half of 2022 with the company growing in ambition and confidence, I remain thankful for the continued trust of investors who have shared our vision, and for the commitment and insight of the many colleagues at Vicore who day by day work to make that vision a reality.

Carl-Johan Dalsgaard

Interim report April-June, 2022; 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 is information that Vicore Pharma Holding AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 08:00 CET on August 25, 2022.

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.