Interim report April - June 2021

STOCKHOLM, Aug. 26, 2021 /PRNewswire/ --

Important events during the second quarter

• In May, Vicore¹ announced that it had entered into a collaboration agreement with Alex Therapeutics for the development of a digital therapeutic (DTx) for patients living with idiopathic pulmonary fibrosis (IPF).
• In June, Vicore announced that it had received approval from the U.S. Food and Drug Administration (FDA) to start the pivotal phase 3 trial with C21 in COVID-19.

Important events after the period

• No important events have occured after the period.

Financial overview for the period

April 1 – June 30, 2021

• Net sales amounted to 0.0 MSEK (0.0)
• The operating loss was -68.4 MSEK (-27.5)
• Loss for the period amounted to -70.4 MSEK (-24.2)
• Loss per share, before and after dilution, was -0.98 SEK (-0.48)
• On June 30, 2021, cash and cash equivalents and short-term investments amounted to 514.4 MSEK (318.7 MSEK as of December 31, 2020)

January 1 - June 30, 2021

• Net sales amounted to 0.0 MSEK (0.0)
• The operating loss was -116.0 MSEK (-56.3)
• Loss for the period amounted to -118.5 MSEK (-52.6)
• Loss per share, before and after dilution, was -1.75 SEK (-1.04)

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

Vicore made several advancements during the second quarter of 2021 with its clinical development programs in both IPF and COVID-19.

In June, Vicore became a phase 3 stage company, as the U.S. Food and Drug Administration (FDA) approved the start of our ATTRACT-3 clinical trial in the United States. ATTRACT-3 is a global, 600 patient, placebo-controlled phase 3 study looking at the effectiveness of C21 to restore lung function in patients who are hospitalized as a result of a COVID-19 infection. Following our successful phase 2 trial conducted during the initial waves of COVID-19, ATTRACT-3 is a pivotal trial which aims to generate key data to enable regulatory bodies, including the FDA, to assess the use of C21 in treating COVID-19 patients.

The green light from the FDA allows hospitals in Vicore's US clinical network to begin recruiting patients. In parallel, Vicore continues the process of activating clinical trial sites in South and Central America, Europe, Africa and Asia. ATTRACT-3 has the go-ahead from regulators in Brazil, Czechia, India, Ukraine and South Africa and study site initiation is ongoing in these countries. 

Vicore's management team and clinical advisors maintain a continuous and open communication with both the science and investment communities. As the COVID-19 pandemic enters its next phase, we continue to emphasize two particularly important aspects of ATTRACT-3: that the study will include patients infected with different variants of COVID-19; and that therapies to improve respiratory outcomes and promote patient recovery directly – as C21 does – will be vital since we will not reach full vaccination in the near term and new, potentially more vaccine resistant, mutations are developing.

Vicore has a 360-degree strategy for addressing serious rare lung diseases. In May, in a collaborative program with Alex Therapeutics, we launched the development of VP04, a proprietary prescription digital therapeutic for patients with idiopathic pulmonary fibrosis (IPF). VP04 will be one element in a suite of treatments for IPF, sitting alongside our development programs for drug therapies such as VP01(C21) and our inhaled thalidomide product for IPF and IPF cough, VP02.

VP04 is designed to support patients in dealing with the psychological burden of IPF and improve quality of life. It is being developed to be prescribed to relevant patients and therefore will need regulatory approval based on clinical evidence of effectiveness. It will also help increase awareness and understanding of IPF amongst healthcare professionals including physicians and payers.

Vicore's other clinical programs in IPF remain on schedule. Results from the phase 2 AIR study of C21 in IPF are expected at the end of 2022 at current recruiting plan and outlook as patient recruitment continues in India, Ukraine, the United Kingdom and Russia. The VP02 program is ready to initiate GLP toxicity studies during the fall of 2021  followed by a phase 1 study in 2022. We remain on course to submit a clinical trial application (CTA) for VP03 by the end of 2021.

The Vicore team is expanding, our possibilities are growing, and our operations are becoming global. As ever, I would like to thank the participants in our clinical trials,  our increasing circle of clinical collaborators around the world, our shareholders for their continuous support of Vicore's work and our employees for responding smoothly to the challenges of growth.

Carl-Johan Dalsgaard

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 August 26, 2021 at 08:00 CET.

1.  The group ("Vicore") consists of the parent company, Vicore Pharma Holding AB (publ)  and the subsidiaries Vicore Pharma AB and INIM Pharma AB.

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