Interim report January - March 2021: Vicore Pharma Holding AB

GOTHENBURG, Sweden, May 5, 2021 /PRNewswire/ -- Vicore Pharma Holding AB (publ) publishes the interim report for the first quarter 2021.

Important events during the first quarter           

• In February, Vicore completed a directed share issue raising 336 MSEK. The share issue was approved at an Extraordinary General Meeting in March.
• In March, Vicore reported top-line data from the mechanistic phase II study in systemic sclerosis and Raynaud's phenomenon (SSc) showing that C21 increased bloodflow in fibrotic tissue.

Important events after the period           

• In May, Vicore announced that it has entered into a collaboration agreement with Alex Therapeutics for the development of a digital therapeutic (DTx) for patients living with idiopathic pulmonary fibrosis (IPF).

Financial overview for the period

January 1 – March 31, 2021           

• Net sales amounted to 0.0 MSEK (0.0)
• The operating loss was -47.5 MSEK (-28.8)
• Loss for the period amounted to -48.1 MSEK (-28.4)
• Loss per share, before and after dilution, was -0.76 SEK (-0.56)
• On March 31, 2021, cash and cash equivalents and short-term investments amounted to 589.9 MSEK (318.7 MSEK as of December 31, 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 20 in the interim report.

CEO Comments

The first quarter of 2021 has been very productive for Vicore continuing to build on the clinical success achieved with C21 in 2020.

In the beginning of February, the company raised 336 MSEK (approx. 40 MUSD) in a directed share issue that attracted Swedish and international institutional investors, including existing shareholders. The strengthened financial position allows Vicore to fund operations well into 2023.

The fundraising followed results of Vicore's phase II COVID-19 trial ATTRACT. The data, published on the online preprint server medRxiv at the beginning of January, showed that C21, Vicore's angiotensin type 2 receptor agonist, spares the need for oxygen supplementation and clearly restores respiratory function in hospitalized COVID-19 patients. Following the successful phase II trial, Vicore's plans for a multinational, placebo-controlled phase III trial of C21 for COVID-19 are well advanced. The phase III trial is scheduled to start in the summer of 2021 once we receive FDA approval to initiate the study.

Vicore's clinical program in idiopathic pulmonary fibrosis (IPF) remains on track. Recruitment for the phase II international AIR study with C21 is on schedule in India, Ukraine, UK and Russia after the first patient was recruited in November 2020. Readout from the AIR study is anticipated for the end of 2022.

Vicore also expects to submit a Clinical Trial Application by the end of 2021 for VP02, Vicore's inhaled formulation of thalidomide for treating IPF and IPF cough.

In March, Vicore also published top line data from our phase II study in systemic sclerosis and Raynaud's phenomenon (SSc) showing that C21 can increase blood flow in fibrotic tissue, a result that further differentiates C21 from its competitors in pulmonary fibrosis, and we anticipate will demonstrate cross-over benefits for patients with IPF.

As part of our continuing commitment to the global community of IPF patients, we have initiated, in collaboration with Alex Therapeutics, an evidence-based digital therapeutic provider, the development of a digital therapeutic (DTx) that will be proprietary to Vicore. The product will be designed to provide cognitive behavioral therapy that IPF patients can use to address the psychological aspect of their disease and to improve patient outcome. The addition of this program, VP04, allows Vicore to offer a comprehensive care package which also includes the highly promising VP01 and VP02 programs targeting the underlying causes and major symptoms of IPF.

The Vicore team continues to respond to challenging and somewhat unforeseen events during the pandemic with great commitment. I would like to thank all our employees for their contributions, and our shareholders for continuing to support our work as we seek to take a whole-patient approach to alleviate the pain and suffering caused by fibrotic lung disease.

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 May 5, 2021 at 08:00 CET.

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SOURCE Vicore Pharma Holding AB