Interim report July - September 2021

GOTHENBURG, Sweden, Nov. 4, 2021 /PRNewswire/ --

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

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, [email protected]  

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

This information was submitted for publication on November 4, 2021 at 08:00 CET.

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SOURCE Vicore Pharma Holding AB