Vicore Pharma Holding AB (publ) publishes the year-end report for 2020

GOTHENBURG, SWEDEN, Feb. 26, 2021 /PRNewswire/ --

Important events during the fourth quarter

• In October, Vicore announced completion of patient enrollment in the phase II study in patients with COVID-19.
• In October, Vicore announced the nomination committee for the 2021 Annual General Meeting.
• In November, Vicore strengthened its pipeline with the acquisition of novel AT2R (angiotensin II type 2-receptor) agonists and decided on an issue in kind of 142,054 shares.
• In November, Vicore announced changes in the management team.
• In November, Vicore recruited the first patient in the phase II Proof-of-Concept study in idiopathic pulmonary fibrosis (IPF).
• In December, Vicore announced positive top line data from the phase II study in patients with COVID-19.
• In December, Vicore announced that the last patient had been treated in the mechanistic phase II study with C21 in systemic sclerosis (SSc).

Important events after the period

• In February, Vicore completed a directed share issue raising 336 MSEK subject to approval at an Extraordinary General Meeting. Pro forma, including the directed share issue, cash and cash equivalents and short-term investments as of December 31, 2020, amounted to 654.7 MSEK.

Financial overview for the period

October 1 - December 31, 2020

• Net sales amounted to 0.0 MSEK (0.0)
• The operating loss was -58.8 MSEK (-30.2)
• Loss for the period amounted to -58.3 MSEK (-27.6)
• Loss per share, before and after dilution, was -0.96 SEK (-0.60)
• On December 31, 2020, cash and cash equivalents and short-term investments amounted to 318.7 MSEK (264.6 MSEK as of December 31, 2019)

January 1 - December 31, 2020

• Net sales amounted to 0.0 MSEK (0.0)
• The operating loss was -149.5 MSEK (-94.0)
• Loss for the period amounted to -146.9 MSEK (-93.1)
• Loss per share, before and after dilution, was -2.71 SEK (-2.16)
• The Board of Directors proposes to the Annual General Meeting that no dividend be paid for the financial year 2020

Financial summary of the group

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.

CEO Comments

"During the fourth quarter and beginning of 2021 we reached several important milestones"

• Reported positive results from our phase II ATTRACT study in COVID-19
• Recruited the first patient in the phase II study in IPF
• Strengthened our pipeline with the acquisition of new novel AT2R agonists
• Completed the recruitment in the mechanistic phase II study in systemic sclerosis and Raynaud's phenomenon
• Secured financing of 336 MSEK through a directed share issue

Positive results in the COVID-19 study and planning for the next step

The encouraging results from the phase II study in COVID-19 (ATTRACT) presented in December clearly showed that C21 restored lung function and normalized gas exchange on top of steroid treatment. The need for oxygen supplementation was gradually lowered in the C21 group compared to the placebo group and about one week after the last dose of C21 there was only one patient in the C21 group needing oxygen compared to eleven in the placebo group -  a reduction of more than 90% (p<0.003).

In the patients needing oxygen treatment, we could also show a statistically significant reduction of CRP (C-reactive protein) at the predefined 10% level.

There was also a clear trend for reduced need of mechanical ventilation and a trend for reduced mortality in the C21 group compared to the placebo group.

Based on these data we see a high potential for C21 as a treatment alternative in COVID-19 and we are now preparing for a phase III study in a larger population in several countries, including the US. We estimate that there will be a need for additional treatments to the vaccines for a longer period as we still see an increased spread of the virus and virus mutations in many parts of the world. There are also other circumstances making it difficult for many people to get the vaccine.  

The IPF study enrolls patients

In November, we announced the first patient recruitment to the phase II IPF study (AIR) in India and we are about to start

recruitment in Ukraine and Russia. Unfortunately, we have not  been able to start the study in the UK yet due to the COVID-19 situation but we are prepared to start as soon as the situation improves.

It has been a struggle to get the study up and running during these special times and I am very proud of my colleagues who have been working very hard to get everything in place and starting the study. We are also very pleased with the collaboration with our CRO, Orphan Reach, and the local sites where the study is performed.

The systemic sclerosis study has finalized the recruitment

In December, we included the last patient in the mechanistic phase II study in systemic sclerosis and Raynaud's phenomenon. Twelve patients have been included in the study and the aim is to evaluate the AT2 receptors' role in acute improvement of blood flow in affected tissues. Positive results will indicate that C21 may have positive effects also on the pulmonary vascular pathology which is common in patients with SSc-related pulmonary fibrosis as well as in IPF.

We are now awaiting the results from the study which have been delayed due to the COVID-19 lock-down but we expect to present the results in March.

The VP02 production have resumed

In the interim report for the third quarter we informed about a delay in the production of our inhaled formulation of thalidomide due to technical issues with the CMO. The issues have been solved and we estimate to submit a CTA for a phase I study by the end of 2021.

The VP03 program develops further

The collaboration with HaLaCore Pharma and Emeriti Bio within the VP03 program develops well. We are now testing several compounds in parallel in different models to investigate their potential as drug candidates.

Successful directed share issue

In February, 2021, we successfully completed a directed share issue, raising 336 MSEK from reputable new and existing investors. The net proceeds will mainly be used for funding our phase III study in COVID-19 including C21 manufacturing and scale up activities and to strengthen the IPF franchise.

Summary

We are proud to say that, despite all difficulties due to the pandemic during 2020, we have been able to move forward with all our projects and in particular that we have concluded two phase II studies and started a third one.

We look forward to continue keeping you updated on our development during 2021!

Carl-Johan Dalsgaard, CEO

For further information, please contact:

Carl-Johan Dalsgaard, CEO, tel: +46 70 975 98 63, [email protected]  

Hans Jeppsson, CFO, tel: +46 70 553 14 65, [email protected]

This information was submitted for publication on February 26, 2021 at 08:00 CET.

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SOURCE Vicore Pharma Holding AB