STOCKHOLM, SE / ACCESS Newswire / August 22, 2025 / Vicore Pharma Holding AB (STO: VICO) ("Vicore"), unlocking the potential of a novel class of drugs, angiotensin II type 2 receptor agonists (ATRAGs), publishes the interim report for the second quarter 2025.
"Vicore's Phase 2b ASPIRE trial remains on track and is expected to complete enrollment in the first half of next year.
During the second quarter, Vicore continued to execute with focus, ensuring efficient site activation and enrollment for the global, randomized Phase 2b ASPIRE trial. The company has a clear path forward for the development of buloxibutid in IPF and has maintained a strong financial position to allow the company to complete this impactful trial with additional cash runway thereafter."
Ahmed Mousa, CEO
Significant events during the second quarter
Continued activation of clinical sites and enrollment of patients in the ASPIRE trial progressing as planned, remaining on track to complete enrollment in the first half of 2026.
In May, Vicore presented at the 2025 American Thoracic Society International Conference, showcasing new translational data demonstrating buloxibutid's unique upstream mechanism of action, a further analysis of buloxibutid's Phase 2a data in idiopathic pulmonary fibrosis (IPF) patients reflecting disease-modifying potential, and the patient-centric approaches that Vicore has taken in both the ongoing Phase 2b ASPIRE study in IPF patients and in digital health innovation.
Vicore participated in several investor conferences in Q2, including Jefferies Global Healthcare Conference, the Van Lanschot Kempen Life Sciences Conference, and the Nordea Equities Healthcare Seminar.
Successful completion of the merger between INIM Pharma AB and its parent company, Vicore Pharma Holding AB.
Significant events after the period
No significant events occurred after the second quarter.
Financial overview for the period
April 1 - June 30, 2025
Revenue amounted to SEK 1.7 million and SEK 0.0 million for the three months ended June 30, 2025 and 2024, respectively.
Operating loss amounted to SEK 111.2 million and SEK 63.1 million for the three months ended June 30, 2025 and 2024, respectively.
Loss for the period amounted to SEK 115.4 million and SEK 56.3 million for the three months ended June 30, 2025 and 2024, respectively.
Loss per share, before and after dilution, amounted to SEK 0.49 and SEK 0.50 for the three months ended June 30, 2025 and 2024, respectively.
On June 30, 2025, cash, cash equivalents, and short-term investments amounted to SEK 937.0 million, equivalent to USD 98.5 million (SEK 1,156.0 million as of December 31, 2024).
January 1 - June 30, 2025
Revenue amounted to SEK 2.6 million and SEK 104.2 million for the six months ended June 30, 2025 and 2024, respectively.
Operating loss amounted to SEK 202.7 million and SEK 40.0 million for the six months ended June 30, 2025 and 2024, respectively.
Loss amounted to SEK 226.9 million and SEK 24.6 million for the six months ended June 30, 2025 and 2024, respectively.
Loss per share, before and after dilution, amounted to SEK 0.97 and SEK 0.22 for the six months ended June 30, 2025 and 2024, respectively.
Financial summary of the group
Amounts in SEK million | 2025 | 2024 | 2025 | 2024 | 2024 |
Revenue | 1.7 | 0.0 | 2.6 | 104.2 | 109.4 |
Operating profit/(loss) | (111.2) | (63.1) | (202.7) | (40.0) | (194.2) |
Profit/(loss) for the period | (115.4) | (56.3) | (226.9) | (24.6) | (168.6) |
Profit/(loss) per share, before/after dilution (SEK)1 | (0.49) | (0.50) | (0.97) | (0.22) | (1.23) |
Research and development costs/operating costs (%)2 | 87.3 | 79.1 | 86.0 | 81.8 | 81.7 |
Equity at the end of the period | 908.3 | 435.0 | 908.3 | 435.0 | 1,129.3 |
Cash flow from operating activities | (106.5) | (49.6) | (192.6) | (26.5) | (165.0) |
Cash and cash equivalents and short-term investments at the end of the period | 937.0 | 466.4 | 937.0 | 466.4 | 1,156.0 |
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 19 in the Interim Report.
CEO Comments
Vicore's Phase 2b ASPIRE trial remains on track and is expected to complete enrollment in the first half of next year.
During the second quarter, Vicore continued to execute with focus, ensuring efficient site activation and enrollment for the global, randomized Phase 2b ASPIRE trial. The company has a clear path forward for the development of buloxibutid in IPF and has maintained a strong financial position to allow the company to complete this impactful trial with additional cash runway thereafter.
The ASPIRE trial was initiated after regulatory clearance in September 2024 and designed to study the change in forced vital capacity (FVC) from baseline over 52-weeks, the registrational endpoint for IPF. We remain on track to enroll the last patient into the study in the first half of 2026, as we have secured regulatory approvals in all 14 participating countries, patient enrollment is progressing as planned, and the quality of participating sites and patient engagement has been very good. We are particularly encouraged by the enthusiasm from the clinical community and the recognition of the transformative potential of buloxibutid's differentiated mechanism of action. Given the unique mechanism of this first-in-class program, buloxibutid has the potential to redefine the treatment paradigm in fibrotic lung disease - not merely slowing disease progression but potentially preserving or improving lung function.
We continue to see strong interest in the trial, supported by the limited number of programs in late-stage development for IPF and the need for more effective and better tolerated therapies. Physicians and patients are also enthusiastic about the trial because of early signal of the excellent tolerability in the Phase 2a study and the patient-friendly trial design. This bodes well for our recruitment plans heading into the second half of 2025.
With the ASPIRE trial and Phase 3 readiness activities progressing, Vicore's management team continued to attend scientific and banking conferences throughout the quarter to keep stakeholders updated on the potential of buloxibutid in IPF and Vicore's future ambitions. Vicore presented multiple oral presentations and posters at the 2025 American Thoracic Society International Conference in May, where the team had the opportunity to highlight new preclinical data supporting buloxibutid's unique mechanism of action. Toby Maher, MD, PhD, Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California, also presented further detail from the Phase 2a AIR trial evaluating buloxibutid in IPF, including a synthetic control arm analysis utilizing real world data from a large cohort of IPF patients, which provided additional support for the robust treatment effect of buloxibutid observed in the Phase 2a AIR study.
Despite the ongoing market volatility driven by continued uncertainty around US tariff policy and broader macroeconomic stability, Vicore is in a fortunate position thanks to the SEK 880 million (USD ~85 million) capital raise during the fourth quarter of 2024.
I want to thank everyone whose support has helped to bring Vicore to where we are today. I'm fortunate to be working alongside a dedicated and talented team and to be supported by shareholders and partners who share our vision and believe in our long-term ambitions. We are entering the second half of the year with strong momentum and a clear sense of purpose: to bring transformational therapies to patients suffering from severe fibrotic diseases. This mission is all the more critical given both the high unmet need that exists for this deadly disease today and the limited late-stage development pipeline.
Ahmed Mousa, CEO
Interim report, Q2 2025; https://vicorepharma.com/investors/financial-reports/
For further information, please contact:
Megan Richards, VP of IR, Communications, and Portfolio Strategy, tel: +1 978 269-4372, megan.richards@vicorepharma.com
Hans Jeppsson, CFO, tel: +46 70 553 14 65, hans.jeppsson@vicorepharma.com
About Vicore Pharma Holding AB (publ)
Vicore Pharma Holding AB is a clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential in respiratory and fibrotic diseases, including idiopathic pulmonary fibrosis (IPF). The company's lead program, buloxibutid (C21), is a first-in-class oral small molecule angiotensin II type 2 (AT2) receptor agonist, which has received Orphan Drug and Fast Track designation from the United States Food and Drug Administration (FDA) and is currently being investigated in the global 52-week Phase 2b ASPIRE trial in IPF.
The company's shares are listed on Nasdaq Stockholm's main market (VICO). www.vicorepharma.com
This information is information that Vicore Pharma Holding is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2025-08-22 08:00 CEST.
Attachments
Interim Report Q2 2025
SOURCE: Vicore Pharma Holding
View the original press release on ACCESS Newswire
