Interim report April-June 2023

2023-08-24 | Regulatory

Stockholm, August 24, 2023 – Vicore Pharma Holding AB (STO: VICO) (“Vicore”), unlocking the potential of a new class of drugs – angiotensin II type 2 receptor agonists (ATRAGs), publishes the interim report for the second quarter 2023.

Important events during the second quarter

  • In May, Vicore reported new interim 36-week data from the phase 2a trial (AIR) in idiopathic pulmonary fibrosis (IPF) demonstrating sustained disease stabilization and increase in lung function in IPF patients.
  • In May, Vicore announced the first patient dosed with C21 in an exploratory trial of endothelial dysfunction using EndoPAT® technology.
  • In May, Vicore strengthened the Board of Directors with the election of Dr. Elisabeth Björk and Dr. Michael Buschle.
  • In May and June, Vicore announced patent protection for enteric coated formulations of C21 in the US and EU.
  • In June, Vicore carried out share issuances of in total 29,875,000 shares at a subscription price of SEK 16.75 per share, raising SEK 500 million (USD 46 million) before transaction costs. Pro forma financial position, including net proceeds from the share issuances, as of June 30, 2023, amounts to approximately SEK 586 million (USD 54 million).

Important events after the period

  • In July, Vicore announced that Ahmed Mousa has been appointed as the new CEO starting in September.
  • In July, Vicore established a wholly-owned US subsidiary, Vicore Pharma US Inc.
  • In August, Vicore announced the results of the exploratory trial using EndoPAT®, as a tool to assess the effect of C21 on endothelial function. Results were inconclusive due to high intra-individual variability.

Financial overview for the period*

April 1 – June 30, 2023

  • Net sales amounted to SEK 0.0 million and SEK 0.0 million for the three months ended June 30, 2023 and 2022, respectively.
  • Operating loss amounted to SEK 69.8 million and SEK 64.9 million for the three months ended June 30, 2023 and 2022, respectively.
  • Loss amounted to SEK 69.2 million and SEK 65.9 million for the three months ended June 30, 2023 and 2022, respectively.
  • Loss per share, before and after dilution, amounted to SEK 0.85 and SEK 0.92 for the three months ended June 30, 2023 and 2022, respectively.
  • On June 30, 2023, cash, cash equivalents, and short-term investments amounted to SEK 259.6 million (SEK 261.7 million as of December 31, 2022).

January 1 – June 30, 2023

  • Net sales amounted to SEK 0.0 million and SEK 0.0 million for the six months ended June 30, 2023 and 2022, respectively.
  • Operating loss amounted to SEK 135.9 million and SEK 158.0 million for the six months ended June 30, 2023 and 2022, respectively.
  • Loss amounted to SEK 135.5 million and SEK 159.2 million for the six months ended June 30, 2023 and 2022, respectively.
  • Loss per share, before and after dilution, amounted to SEK 1.64 and SEK 1.75 for the six months ended June 30, 2023 and 2022, respectively.

Financial summary of the group

Amounts in SEK million 2023 Apr-Jun 2022 Apr-Jun 2023
Jan-Jun
2022
Jan-Jun
2022
Jan-Dec
Net sales 0.0 0.0 0.0 0.0 0.0
Operating loss (69.8) (64.9) (135.9) (158.0) (290.7)
Loss for the period (69.2) (65.9) (135.5) (159.2) (288.4)
Loss per share, before/after dilution (SEK)1 (0.85) (0.92) (1.64) (1.75) (3.99)
Research and development costs/
operating costs (%)2
85.9 84.1 85.7 85.3 85.5
Equity at the end of the period 302.1 228.1 302.1 228.1 289.1
Cash flow from operating activities (69.1) (61.3) (146.8) (132.9) (299.9)
Cash and cash equivalents and short-term
investments at the end of the period
259.6 236.6 259.6 236.6 261.7

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 17 in the interim report.

* Financial information is provided in SEK million (previously MSEK) and negative values in tables are within parenthesis (previously minus sign).

CEO Comments

The second quarter was important for Vicore, as the enrolment into the idiopathic pulmonary fibrosis (IPF) AIR[1] trial concluded after reporting of unprecedented data that confirmed previous data further supporting C21's role as a potentially transformative therapy for the disease.

Following the release of this strong interim data, Vicore successfully raised SEK 500 million (USD 46 million) attracting new high-quality US investors such as Orbimed as well as European specialist investors. The funds will be used to initiate the phase 2b “ASPIRE” dose confirmatory trial with C21 in IPF (previously named ANDAS). The ASPIRE trial aims to provide “substantial evidence of effectiveness” and will be a 52-week, randomized, double-blind, placebo-controlled, multicenter study. The aim is to commence this study in H1 2024.

C21 and other angiotensin II type 2 receptor agonists (ATRAGs) have a mode of action distinct from any other IPF approach, designed to activate physiological repair systems, restoring alveolar integrity and improving lung function. These effects were most prominent in patients with early IPF, with the potential for functional recovery most likely due to breakdown of newly formed fibrosis and increased lung elasticity. Notably, all subgroups, including early/established disease, male/female, and patients from Asia versus rest of the world, experienced stabilization above baseline.

During the second quarter, Vicore secured and strengthened its product protection by receiving patent approval which covers enteric coated (EC) formulations of C21 in the US and EU. The protection is valid until 2041 and is not limited to any specific disease.

The restoration of cellular function with ATRAGs extends beyond alveolar epithelial cells and is likely to also be applicable to vascular endothelial cells. C21 has demonstrated an increase in human forearm blood flow through stimulation of nitric oxide release, a mechanism that is highly relevant for pulmonary hypertension and other vascular diseases. To find a simple technique for measuring changes in endothelial function, an exploratory study[2] has been completed in T2DM patients using a diagnostic device entitled EndoPAT®. However, due to a low intra-individual reproducibility and thus a high variability, the conclusion was that the EndoPAT® technology does not fulfil Vicore’s needs.

In addition, the first in-human clinical trial with Vicore’s next ATRAG C106[3] has now been completed and data is due to be presented during the second half of this year. The third ATRAG in the pipeline, C103, has completed IND enabling toxicology studies, and formulation development is ongoing.

We are concluding patient recruitment to the COMPANION[4] study for the digital therapeutic, AlmeeTM in patients with pulmonary fibrosis after confirming a robust data set is in place to convincingly evaluate the effect of AlmeeTM. The total number of patients in the study will be approximately 110.

As Vicore is evolving into a late-stage clinical development company, with established visibility in the US market, the timing was right for me to announce that I will be stepping down from my role as CEO of Vicore. I am very pleased that Ahmed Mousa, the current Chief Business Officer of Pieris Pharmaceuticals, has accepted the role as the new CEO. Ahmed has a highly relevant background with a successful business development track record and an extensive US network making him the ideal candidate for the position. As part of this US expansion, Vicore has established a subsidiary, Vicore Pharma US Inc, to accomodate activities in the US. Furthermore, the company's board of directors has been strengthened with expertise in late-stage clinical development and pharmaceutical development in general, thanks to the additions of Dr. Elisabeth Björk and Dr. Michael Buschle. With these strong additions to the team, I would like to thank everyone for the very exciting time as CEO and look forward to Vicore embarking on its next steps, continuing its journey in the development of treatments for severe disease.

Carl-Johan Dalsgaard, CEO

Interim report April-June, 2023; https://vicorepharma.com/investors/financial-reports/

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

About Vicore Pharma Holding AB (publ)
Vicore is an innovative Swedish clinical-stage pharmaceutical company unlocking the potential of a new class of drugs to stop disease progression and restore function. The company is establishing a portfolio in rare lung diseases including idiopathic pulmonary fibrosis (IPF) and pulmonary arterial hypertension (PAH). C21 is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in a phase 2a study of IPF. C21 is protected by US and European orphan drug designation. A variety of patents have been filed to provide further protection for C21, out to 2040 and onwards. Almee™ (an investigational medical device in clinical development) is a digital therapeutic (DTx) based on cognitive behavioral therapy (CBT) created to address the psychological impact of living with pulmonary fibrosis. Inhaled IMID is a new formulation and delivery route of thalidomide targeting the severe cough associated with IPF. Using its unique expertise in the ATRAG biology Vicore is further fueling its pipeline with several new small molecule drug assets, with long patent life and for a variety of indications, some of which could be partnered while others may be taken to the market by Vicore.

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

[1] NCT04533022
[2] NCT05831644
[3] NCT05427253
[4] NCT05330312