Interim report July-September 2020

2020-11-06

Gothenburg, November 6, 2020 - Vicore Pharma Holding AB (publ) publishes the interim report for the third quarter 2020.

Important events during the third quarter

  • In July, Vicore completed a directed share issue resulting in proceeds of 185 MSEK before
    transaction costs.
  • In July, Vicore announced that the first patient with COVID-19 had been dosed in the ATTRACT study in India.
  • In August, Vicore announced that the study with VP01 in patients with systemic sclerosis had restarted after the pause caused by the COVID-19 pandemic.
  • In September, Vicore announced that treatment with VP01 on lung tissue with idiopathic pulmonary fibrosis (IPF) caused a dose-dependent decrease of TGFβ1, a key growth factor in fibrosis development.
  • In September, Vicore announced that the last patient had been included in the ATTRACT study in COVID-19.

Important events after the period

  • In November, Vicore acquired a series of intellectual property rights (IPR) from HaLaCore Pharma AB ("HaLaCore") as part of the development of novel angiotensin II type 2 receptor (AT2R) agonists.
  • In November, Vicore announced  changes in the management team.

Financial overview for the period

July 1 - September 30, 2020

  • Net sales amounted to 0.0 MSEK (0.0)
  • The operating loss was -34.4 MSEK (-22.8)
  • Loss for the period amounted to -36.0 MSEK (-22.9)
  • Loss per share, before and after dilution, was -0.65 SEK (-0.54)
  • On September 30, 2020, cash and cash equivalents and short-term investments amounted to 361.4 MSEK (264.6 MSEK as of December 31, 2019)

January 1 - September 30, 2020

  • Net sales amounted to 0.0 MSEK (0.0)
  • The operating loss was -90.7 MSEK (-63.8)
  • Loss for the period amounted to -88.6 MSEK (-65.5)
  • Loss per share, before and after dilution, was -1.70 SEK (-1.56)

Financial summary of the group

Amounts in MSEK 2020
Jul-Sep
2019
Jul-Sep
2020
Jan-Sep
2019
Jan-Sep
2019
Jan-Dec
Net sales 0.0 0.0 0.0 0.0 0.0
Operating loss -34.4 -22.8 -90.7 -63.8 -94.0
Loss for the period -36.0 -22.9 -88.6 -65.5 -93.1
Loss per share, before/after dilution (SEK)1 -0.65 -0.54 -1.70 -1.56 -2.16
Research and development costs/
operating costs (%)2
85.2 75.0 84.8 68.2 71.3
Equity at the end of the period 412.0 231.3 412.0 231.3 321.6
Cash flow from operating activities -26.1 -21.3 -81.2 -62.2 -87.0
Cash and cash equivalents and short-term
investments at the end of the period
361.4 172.2 361.4 172.2 264.6

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 25 in the interim report.

CEO Comments

The third quarter was characterized by intense activities, especially within clinical development.

The ATTRACT-study fully recruited in two months

After we established that we would not reach the sufficient number of COVID-19 patients in the UK, we did a careful analysis of three other countries with still rising cases; India, Ukraine and Russia. We decided to continue with all three of them and started to include patients in India already by the end of July and then finalized the recruitment with 106 patients by the end of September, which was at the same time as the regulatory processes in Ukraine and Russia were finalized. We can now conclude that we are among a few companies with a new molecule that, so far, have managed to complete a controlled COVID-19 study. We are now following up that all data points are correct before the statisticians can analyze the data. We expect to publish top-line results before year end.

We would like to take the opportunity and thank medical research charity LifeArc for the grant of 18.5 MSEK which was a contributing factor for us to realize the study.

The IPF study is expanding

In parallel with the investigation to move the COVID-19 study, we decided to do the same exercise with the IPF-study and investigated the possibility to expand to India, where we now have regulatory approval, as well as Ukraine and Russia, where regulatory processes are ongoing. We already have approval to start the study in the UK; however, because COVID-19 cases are increasing again in the UK and because IPF patients are particularly sensitive to infection, it will take some time before the study can start there. In India, not all hospitals are treating COVID-19 patients and therefore it will be safer for the patients attending the study. Considering the COVID-19 situation, it is difficult to give a prognosis for when the read-out of the study may occur. It is highly dependable on how the pandemic develops and how soon we can have more clinics up and running. The target is still to finalize the study in 2022.

The systemic sclerosis study is recruiting patients again

The study on blood-flow in patients with systemic sclerosis and Raynaud’s phenomenon has resumed after a pause due to the COVID-19 situation in the UK. The recruitment pace is a bit slower than earlier but we hope to finalize the recruitment before year end, unless new restrictions put a stop to it.

Confirming data in human lung tissue from IPF-patient

Lung tissue from IPF patients, who have undergone lung transplantation, can be used as a model to measure effects of drugs in this disease. Vicore has conducted such a study with VP01 and found that the ATR receptor (the target of VP01) was expressed in the tissue. Furthermore, it was found that VP01 in clinically relevant concentrations caused a dose-dependent decrease of TGFβ1, a key growth factor in fibrosis development. It is very encouraging that we have been able to show clear effects in the right tissue, right species (human) and in the right concentrations.

The VP02 program initiates technical transfer for clinical (GMP) production

The inhaled formulation for local administration of an IMiD to treat IPF and IPF related cough is in preclinical development undergoing formulation optimization and preparations for toxicity studies. The production of the substance for the first clinical study has been delayed due to a technical disturbance with the British producer. The disturbance is expected to be sorted out and corrected within soon, but we estimate around six months delay in the development work due to this.

The VP03 program develops further

The VP03 program, where new patent protected AT2 receptor agonists are developed, continues in good pace and we have recently acquired a series of new patent applications from HaLaCore for further development.

Changes in the management team

The development phase we are in means a larger focus on our projects and project management to effectively achieve our goals and therefore we have decided to increase the management team in Vicore. The management team will consist of the following persons; Carl-Johan Dalsgaard (CEO), Hans Jeppsson (CFO), Rohit Batta (CMO), Johan Raud (CSO), Elin Rosendahl (VP Clinical Development), Ola Camber (Head of Pharmaceutical R&D, Nina Carlén (CAO) och Johanna Gräns (Preclinical Development).

Summary

During the third quarter, we completed a phase II study and resumed one. We are well positioned to develop new therapies for patients with fibrotic lung disease.

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 November 6, 2020 at 08:00 CET.

  • Interim report Q3 2020