Stockholm, February 28, 2023 - Vicore Pharma Holding AB (publ) publishes the year-end report for 2022.
Important events during the fourth quarter
- In October, Vicore announced results in a pilot study with the investigational digital therapeutic AlmeeTM, addressing pulmonary fibrosis-related anxiety, which demonstrated a nearly 50% reduction in anxiety measured by the GAD-7 scale.
- In October, Vicore announced that C103, a novel angiotensin II type 2-receptor agonist (ATRAG), was selected as a drug candidate.
- In November, a second interim analysis of the AIR phase 2a trial in idiopathic pulmonary fibrosis (IPF) with C21 showed stabilization of disease, reinforcing previously presented data and further strengthening the benefit-risk profile.
- In December, Vicore announced that the first patient had been enrolled in COMPANION; a pivotal study with AlmeeTM.
- In December, Vicore successfully completed a directed share issue raising gross proceeds of 200 MSEK before transaction costs.
Important events after the period
- In January, Vicore divested its entire holding of 91,829 shares in I-Tech AB (publ). As of December 31, 2022, the value of the financial asset was approximately 4.9 MSEK.
Financial overview for the period
October 1 – December 31, 2022
- Net sales amounted to 0.0 MSEK (0.0)
- The operating loss was -63.0 MSEK (-81.1)
- Loss for the period amounted to -60.7 MSEK (-80.4)
- Loss per share, before and after dilution, was -0.83 SEK (-1.12)
- On December 31, 2022, cash, cash equivalents and short-term investments amounted to 261.7 MSEK (371.5 MSEK as of December 31, 2021)
January 1 – December 31, 2022
- Net sales amounted to 0.0 MSEK (0.0)
- The operating loss was -290.7 MSEK (-294.8)
- Loss for the period amounted to -288.4 MSEK (-296.5)
- Loss per share, before and after dilution, was -3.99 SEK (-4.25)
- The Board of Directors proposes to the Annual General Meeting that no dividend be paid for the financial year 2022
Financial summary of the group
|Amounts in MSEK||2022 Oct-Dec||2021 Oct-Dec||2022|
|Loss for the period||-60.7||-80.4||-288.4||-296.5|
|Loss per share, before/after dilution (SEK)1||-0.83||-1.12||-3.99||-4.25|
|Research and development costs/|
operating costs (%)2
|Equity at the end of the period||289.1||383.3||289.1||383.3|
|Cash flow from operating activities||-100.3||-75.3||-299.9||-265.2|
|Cash and cash equivalents and short-term |
investments at the end of the period
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 year-end report.
During the first few weeks of treatment with C21 in patients with IPF the disease stabilizes and after week 18 we start to see that some patients without end-stage fibrotic destruction are gaining lung function.
2022 has been a successful year. Despite the pandemic and ongoing war situation between Ukraine and Russia, where we had study sites, we have managed to recruit patients to our lead program, the phase 2a trial (AIR) in idiopathic pulmonary fibrosis (IPF) and the interim results from February and November are very encouraging. During the first few weeks of treatment with C21 the disease stabilizes and after week 18 we start to see that some patients without end-stage fibrotic destruction are gaining lung function. Our intent is to repeat in a larger placebo-controlled phase 2b trial (ANDAS). Our focus is to get the trial up and running because we see C21 could be a game-changer for IPF patients. With early diagnosis and early treatment there is an opportunity to not only stop the disease but possibly also to reverse it. During 2023, the data set will mature and we expect the final read-out by the end of the year with the possibility for another interim analysis in between.
To prepare for the next step in IPF we have conducted a meeting with the FDA to discuss the planning of the ANDAS trial. The ANDAS trial is designed with the input of an advisory committee formed of six key opinion leaders from different countries co-chaired by Professor Toby Maher.
All patients with IPF have a vascular component to the disease in addition to their lung fibrosis and the fact that we have shown effects on blood vessels in the forearm blood flow study with C21 in healthy volunteers is encouraging. Many IPF patients also have pulmonary hypertension as a concomitant disease, which has prompted us to look at pulmonary arterial hypertension (PAH) as an indication for future development. Given that this is a microvascular disease, a proof of principle study assessing endothelial function could serve as an indicator of effect on pulmonary hypertension.
To further strengthen our patient focused portfolio in rare lung disease, we are developing a digital cognitive behavioral therapy (DTx) for the treatment of anxiety in association with pulmonary fibrosis (AlmeeTM), which is a huge unmet medical need. In the recent pilot study we found that about two thirds of all IPF patients had anxiety that could be treated with cognitive behavioral therapy. The one-month pilot study showing a 50% decrease in anxiety, along with the pivotal trial, will form the basis for a regulatory submission to approve the use of AlmeeTM as a medical device. The pivotal study, named COMPANION, is a decentralized trial and expected to conclude by the end of 2023.
AlmeeTM has been very well received by patients, patient organizations and key opinion leaders. It is viewed as having great potential to be an important product that will strengthen Vicore’s position within the IPF community.
For the treatment of IPF cough we have shifted approach to a carrier-free free formulation of thalidomide that is currently evaluated in preclinical studies.
The knowledge around the Angiotensin II type 2 receptor (AT2 receptor) biology has increased during the year and in total more than 100 scientific papers have been published only on C21, underscoring the importance of this receptor in regeneration and repair in a variety of diseases.
Our own efforts with novel ATRAGs (Angiotensin II type 2 receptor agonists) have made significant progress during the year and in total more than 400 compounds have now been synthetized and tested and together constitute several different classes of molecules covered by eight pending patents. These compounds will have patent protection to 2041 and beyond.
We are advancing several new compounds with different properties; the first of which (C106), started a phase 1 trial in 2022. This trial is expected to finish during the first half of 2023. A second new compound (C103) is in final toxicological testing.
We have strengthened the management team with two senior recruitments, highly relevant for the development stage we are in, Caroline Spearpoint, Therapy Area Lead, rare lung disease and Stine Furbo, Director of Pharmaceutical Development.
Despite the challenging financial market, we successfully completed a 200 MSEK financing round in December, which strengthens our financial position. The proceeds will be used to complete the AIR trial, continue preparations for the phase 2b ANDAS trial, market preparations for AlmeeTM and to advance the development of C106.
We look forward to a transformative 2023 when the AIR trial will be concluded and our focus is shifted towards the phase 2b ANDAS trial, the completion of the COMPANION trial and with the first new ATRAG, C106, in clinical phase. We also expect a broader appreciation of the AT2 receptor biology in medicine, an area where Vicore through its ATRAG portfolio is leading the way. I am truly grateful for the support of our investors and the investigators and patients who are part of our clinical trials and our valuable collaboration partners. Last and not least I am grateful for the ingenuity and support of the Vicore team.
Carl-Johan Dalsgaard, CEO
Interview with CEO Carl-Johan Dalsgaard at 14:00 CET on February 28
Today at 14:00 CET, an interview with CEO Carl-Johan Dalsgaard will be published on the company's website: https://vicorepharma.com/investors/events-presentations/
Year-end report 2022: https://vicorepharma.com/investors/financial-reports/
For further information, please contact:
Carl-Johan Dalsgaard, CEO, tel: +46 70 975 98 63, email@example.com
Hans Jeppsson, CFO, tel: +46 70 553 14 65, firstname.lastname@example.org
This information was submitted for publication on February 28, 2023, at 08:00 CET.
About Vicore Pharma Holding AB (publ)
Vicore is an innovative Swedish clinical-stage pharmaceutical company dedicated to creating life- changing treatments in diseases where the angiotensin II type 2 receptor (AT2 receptor) has a central role in stopping and reversing disease pathology. 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). Almee™ (an investigational medical device pending FDA clearance) 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. With our unique expertise in the ATRAG biology we fuel our pipeline with several new assets for a variety of diseases, some of which could be partnered while others can 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.