Important events during the first quarter
- In January, Vicore announced discontinuation of the preclinical IMiD program to focus resources on advancing buloxibutid (C21) for patients with idiopathic pulmonary fibrosis (IPF).
- In January, Vicore reported positive results in the pivotal study of AlmeeTM, a digital therapeutic for the treatment of anxiety in pulmonary fibrosis.
- In February, Vicore announced an exclusive license agreement with
Nippon Shinyaku Co. Ltd. to develop and commercialize buloxibutid inJapan . Vicore will receive an upfront payment ofUSD 10 million and is entitled to up toUSD 275 million in milestones in addition to tiered royalty payments into the low 20s. - In March, Vicore announced FDA Breakthrough Device Designation for AlmeeTM.
- In March, Vicore announced an oral late-breaking presentation of the final results from the Phase 2a AIR trial of buloxibutid in IPF, to be presented at the 2024
American Thoracic Society International Conference in May.
Important events after the period
- No important events occurred after the period.
Financial overview for the period
- Net revenues amounted to
SEK 104.2 million andSEK 0.0 million for the three months endedMarch 31, 2024 and 2023, respectively. - Operating profit/(loss) amounted to
SEK 23.2 million and (SEK 66.1 million ) for the three months endedMarch 31, 2024 and 2023, respectively. - Profit/(loss) amounted to
SEK 31.7 million and (SEK 66.3 million ) for the three months endedMarch 31, 2024 and 2023, respectively. - Profit/(loss) per share, before and after dilution, amounted to
SEK 0.28 and (SEK 0.81 ) for the three months endedMarch 31, 2024 and 2023, respectively. - On
March 31, 2024 , cash, cash equivalents, and short-term investments amounted toSEK 512.2 million , equivalent toUSD 48.0 million (SEK 482.8 million as ofDecember 31 , 2023).
Financial summary of the group
Amounts in SEK million | 2024 Jan-Mar | 2023 Jan-Mar | 2023 Jan-Dec |
Net revenues | 104.2 | 0.0 | 0.0 |
Operating profit/(loss) | 23.2 | (66.1) | (321.5) |
Profit/(loss) for the period | 31.7 | (66.3) | (310.9) |
Profit/(loss) per share, before/after dilution | 0.28 | (0.81) | (3.22) |
Research and development costs/ operating costs (%)2 | 84.0 | 85.4 | 85.4 |
Equity at the end of the period | 488.8 | 224.6 | 455.4 |
Cash flow from operating activities | 23.1 | (77.7) | (249.6) |
Cash and cash equivalents and short-term investments at the end of the period | 512.2 | 183.6 | 482.8 |
1 No dilutive effect arises for potential common shares for periods when the result is negative or when the exercise price for options or share awards exceeds the average market price.
2 Alternative performance measure (APM). Defined on page 17 in the interim report.
CEO Comments
During the first quarter, we continued to advance our Phase 2a AIR study of
buloxibutid in patients suffering from idiopathic pulmonary fibrosis (IPF), with the final patient‘s last visit completed. Since the quarter ended, we announced that we will be presenting the final Phase 2a AIR data in an oral late-breaking presentation at the ATS (
The first quarter of 2024 was an eventful time at Vicore, which was highly focused on advancing our drug candidate for patients with IPF, buloxibutid (C21). We started the year with
The partnership with
The phase 2b ASPIRE study will be a 52-week randomized, double-blind, placebo-controlled, parallel-group, multicentre trial of two doses of buloxibutid. The aim is to include 270 patients (90 per treatment arm) with IPF, either not treated with antifibrotics or on stable nintedanib therapy. The primary endpoint will be a change from the baseline in FVC (forced vital capacity). We have been working closely with patients, patient organizations, our advisory committee, and clinical experts within the respiratory field to develop the best possible study design.
We are also working actively on development paths for AlmeeTM, our digital therapeutic treating anxiety in pulmonary fibrosis. The results from the pivotal study COMPANION showed a clear clinical benefit compared to the control group, with a significant reduction in anxiety among patients with pulmonary fibrosis. The results are outstanding and show how important this tool can be in supporting the patients' need for psychological support during a difficult disease. COMPANION enrolled 108 participants from across
In parallel, Vicore continues evaluating novel angiotensin II type 2 receptor agonists (ATRAGs) in our early development programs. These ATRAGs could be developed in other indications where the AT2 receptor plays a central role and we are currently reviewing several indications where we believe this mechanism may have a disease-modifying effect and be well suited for treatment with our ATRAG molecules.
I want to express my gratitude to our employees, patients and patient organizations, advisors, partners, and shareholders for their continued support and trust. We are convinced of the need to develop buloxibutid for IPF and look forward to continuing this journey together with all of you.
Interim report, Q1 2024:
https://vicorepharma.com/investors/financial-reports/
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About
Vicore is an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. The company is establishing a portfolio in respiratory diseases, including idiopathic pulmonary fibrosis (IPF). Buloxibutid (C21) is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in phase 2a development for IPF. Almee™ (an investigational medical device in clinical development) is a digital therapeutic based on cognitive behavioral therapy created to address the psychological impact of living with pulmonary fibrosis. Almee has received Breakthrough Device Designation from the FDA, reflecting its potential to have transformative impact. Using its unique expertise in ATRAG chemistry and biology, Vicore is further fueling its pipeline with several new therapies across additional potential indications. The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.
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