Interim report April-June 2020

Gothenburg, August 26, 2020 - Vicore Pharma Holding AB (publ) publishes the interim report for the second quarter 2020.

Important events during the second quarter

• In April, Vicore Pharma gained approval from the UK regulatory agency MHRA, to start the phase II study with VP01 on patients with COVID-19. The ATTRACT study is a randomized, double blind, placebo controlled study in approximately 100 COVID-19 patients with a moderately severe disease, treated with basic respiratory care, but not on mechanical ventilation. The study will investigate the efficacy on respiratory failure and functional outcomes.
• In May, Vicore Pharma received approval from the UK regulatory agency MHRA, to start the phase II study with VP01 in patients with idiopathic pulmonary fibrosis (IPF).
• In May, Vicore Pharma was awarded a grant of 1.5 GBP million from the UK charity LifeArc for the  ATTRACT study in patients with COVID-19.
• In June, Vicore Pharma announced positive results with VP01 in a preclinical model considered predictive of human pulmonary hypertension.
• In June, Vicore Pharma announced that the ATTRACT study with VP01 on COVID-19 will expand to India in order to accelerate patient enrolment. A clinical trial application has been submitted and approved by the health authorities in India.

Important events after the period

• In July, Vicore completed a directed share issue resulting in proceeds of 185 MSEK before
  transaction costs. Pro forma, including the directed share issue, cash and cash equivalents and short-term investments per June 30, 2020, amounted to 397.4 MSEK.
• In July, Vicore Pharma announced that the first patient with COVID-19 has been dosed in the ATTRACT study in India.
• In August, Vicore Pharma announced that the study with VP01 in patients with systemic sclerosis had restarted after the pause caused by the COVID-19 pandemic.

Financial overview for the period

April 1 - June 30, 2020

• Net sales amounted to 0.0 MSEK (0.0)
• The operating loss was -27.5 MSEK (-24.8)
• Loss for the period amounted to -24.2 MSEK (-26.6)
• Loss per share, before and after dilution, was -0.48 SEK (-0.63)
• On June 30, 2020, cash and cash equivalents and short-term investments amounted to 212.4 MSEK (264.6 MSEK as of December 31, 2019)

January 1 - June 30, 2020

• Net sales amounted to 0.0 MSEK (0.0)
• The operating loss was -56.3 MSEK (-40.9)
• Loss for the period amounted to -52.6 MSEK (-42.6)
• Loss per share, before and after dilution, was -1.04 SEK (-1.02)

Financial summary of the group

1 There is no dilution effect for potential ordinary shares for periods where earnings have been negative.

CEO Comments

The second quarter was intense with setting up the phase II VP01 studies ATTRACT (COVID-19) and the IPF study. We also had several investor meetings leading up to a capital raise on July 2, reducing the financial risks and expectedly extending the runway well beyond the readout of the phase II study in IPF.

The ATTRACT study expands to recruit outside the UK

ATTRACT (Angiotensin II Type Two Receptor Agonist COVID-19 Trial) is targeting hospitalized patients treated with basic respiratory care, but not on mechanical ventilation. These patients have a marked inflammatory drive which can lead to acute respiratory failure if it progresses.

At the end of April, we announced approval of the clinical trial application (CTA) from the UK regulatory agency MHRA in record time and we have now full regulatory approval in the UK. In June, the number of cases in the UK was going down and in order to accelerate recruitment we performed a thorough feasibility study in countries outside the UK and decided to file also in India, where the number of cases is still on the rise. The CTA was approved in mid-June and at the end of July, the first patient was dosed. Although predictions of COVID-19 in India are extremely difficult we expect the study to be completed by year end.

In strong competition, the ATTRACT study was awarded a grant from the UK charity LifeArc of approximately 1.5 GBP million (18.5 MSEK) after prioritization by an expert panel.

The IPF study approved in the UK

The IPF study is a multi-center, open-label, single-arm trial investigating the safety, efficacy, and pharmacokinetics of VP01 in subjects with IPF. It was approved by the UK regulatory agency MHRA in May and pending the development of COVID-19 the company still expects the study to start late Q3. However, to make sure that we do not depend on a single country, feasibility studies have been performed in other countries and also for this study a clinical trial application has been submitted to the Indian authorities as the first country outside of the UK. The study will include approximately 60 patients and the observed treatment effect of VP01 for six months will be compared with the well-documented linear decline of lung function in untreated patients.

The SSC study has started again and is still on track

In the mechanistic study in patients with systemic sclerosis (SSc) and Raynaud's phenomena, the effect of VP01 on blood flow in small vessels is investigated. This will, together with the elaborate animal model of pulmonary hypertension, determine the effect on vasculopathy. The recruitment to this study was ahead of schedule when we needed to pause due to COVID-19. It has now started again and if the COVID-19 situation does not change, we expect the study to be completed  by the end of the year.

Intriguing data from an animal model of pulmonary hypertension

In the gold-standard preclinical model, considered predictive of human pulmonary hypertension, the so called Sugen-hypoxia model, VP01 demonstrated both hemodynamic effects and reduced vascular remodeling. This together with the anti-fibrotic effects give VP01 a unique profile.

The VP02 program starts tech transfer for clinical (GMP) production

The inhaled formulation for local delivery of an IMiD to treat IPF-related cough, is in a preclinical development phase, finetuning the formulation and preparing for the toxicological studies. In order to manufacture the product for the first clinical trial, the company has entered an agreement with Nanologica AB for tech transfer to the UK manufacturer Sterling Ltd.

The VP03 program advances

In the VP01 follow up project, two classes of novel and unique compounds have been identified and patent applications filed. One of these compounds is now progressing to toxicological studies.

Successful capital raise

In early July, we successfully completed a share issue of approximately 185 MSEK directed to Swedish and foreign institutions. Once again, we received a significant interest from specialized and long-term investors, both existing and new. Through the proceeds we strengthened our balance sheet significantly, which reduces the financial risks in the company and allows us to accelerate the pace of our programs, not least the development of VP03.

To summarize, we are now prepared to have three phase II studies up and running during the second half of 2020 and have a healthy financial position.

Carl-Johan Dalsgaard, CEO

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 26 August 2020 at 08:00 CET.

About Vicore Pharma Holding AB (publ)
VVicore Pharma is a rare disease pharmaceutical company focused on rare lung disorders and related indications. The company currently has three drug development programs, VP01, VP02 and VP03.

VP01 (C21) is being developed for the treatment of idiopathic pulmonary fibrosis (“IPF”), pulmonary fibrosis in systemic sclerosis (“SSc”) and COVID-19. VP02 is based on a new formulation and delivery route of an existing immunomodulatory compound (an “IMiD”). VP02 focuses on the underlying disease and the severe cough associated with IPF. VP01 and VP02 are also being actively evaluated for other indications within the field of interstitial lung diseases where there are significant unmet needs. VP03 includes follow-up molecules for VP01.

The company's shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.