STOCKHOLM, SE / ACCESS Newswire / November 5, 2025 / Vicore Pharma Holding (STO:VICO) - Stockholm, November 5, 2025 - Vicore Pharma Holding AB (STO:VICO) unlocking the potential of a novel class of drugs, angiotensin II type 2 receptor agonists (ATRAGs), publishes the interim report for the third quarter 2025.
"ASPIRE is on track to complete enrollment in the first half of 2026, with continued enthusiasm fueled by new data supporting buloxibutid's disease-modifying signal in the Phase 2a AIR trial."
Ahmed Mousa, CEO
Significant events during the third quarter
Buloxibutid received Orphan Drug designation in Japan for the treatment of idiopathic pulmonary fibrosis (IPF).
Vicore presented new findings from the 36-week Phase 2a AIR trial of buloxibutid in IPF, including a synthetic control arm analysis, at the European Respiratory Society (ERS) Congress 2025, confirming the disease-modifying effect observed in the study.
Significant events after the period
No significant events occurred after the third quarter.
Financial overview for the period
July 1 - September 30, 2025
Revenue amounted to SEK 0.8 million and SEK 0.0 million for the three months ended September 30, 2025 and 2024, respectively.
Operating loss amounted to SEK 116.0 million and SEK 60.1 million for the three months ended September 30, 2025 and 2024, respectively.
Loss for the period amounted to SEK 113.5 million and SEK 60.0 million for the three months ended September 30, 2025 and 2024, respectively.
Loss per share, before and after dilution, amounted to SEK 0.48 and SEK 0.53 for the three months ended September 30, 2025 and 2024, respectively.
On September 30, 2025, cash, cash equivalents, and short-term investments amounted to SEK 835.8 million, equivalent to USD 88.8 million (SEK 1,156.0 million as of December 31, 2024).
January 1 - September 30, 2025
Revenue amounted to SEK 3.4 million and SEK 104.2 million for the nine months ended September 30, 2025 and 2024, respectively.
Operating loss amounted to SEK 318.7 million and SEK 100.1 million for the nine months ended September 30, 2025 and 2024, respectively.
Loss amounted to SEK 340.4 million and SEK 84.6 million for the nine months ended September 30, 2025 and 2024, respectively.
Loss per share, before and after dilution, amounted to SEK 1.45 and SEK 0.75 for the nine months ended September 30, 2025 and 2024, respectively.
Financial summary of the group
Amounts in SEK million | 2025 | 2024 | 2025 | 2024 | 2024 |
Revenue | 0.8 | 0.0 | 3.4 | 104.2 | 109.4 |
Operating profit/(loss) | (116.0) | (60.1) | (318.7) | (100.1) | (194.2) |
Profit/(loss) for the period | (113.5) | (60.0) | (340.4) | (84.6) | (168.6) |
Profit/(loss) per share, before/after dilution (SEK)1 | (0.48) | (0.53) | (1.45) | (0.75) | (1.23) |
Research and development costs/operating costs (%)2 | 84.6 | 80.7 | 85.5 | 81.5 | 81.7 |
Equity at the end of the period | 798.7 | 377.7 | 798.7 | 377.7 | 1,129.3 |
Cash flow from operating activities | (100.4) | (87.3) | (293.0) | (113.8) | (165.0) |
Cash and cash equivalents and short-term investments at the end of the period | 835.8 | 380.4 | 835.8 | 380.4 | 1,156.0 |
Amounts in USD3 million | 2025 | 2024 | 2025 | 2024 | 2024 |
Revenue | 0.1 | 0.0 | 0.3 | 9.9 | 10.4 |
Operating profit/(loss) | (12.2) | (5.8) | (32.0) | (9.5) | (18.4) |
Profit/(loss) for the period | (11.9) | (5.8) | (34.2) | (8.1) | (16.0) |
Profit/(loss) per share, before/after dilution (SEK)1 | (0.05) | (0.05) | (0.15) | (0.07) | (0.12) |
Research and development costs/operating costs (%)2 | 84.6 | 80.7 | 85.5 | 81.5 | 81.7 |
Equity at the end of the period | 84.8 | 37.4 | 84.8 | 37.4 | 102.7 |
Cash flow from operating activities | (10.5) | (8.4) | (29.4) | (10.8) | (15.6) |
Cash and cash equivalents and short-term investments at the end of the period | 88.8 | 37.7 | 88.8 | 37.7 | 105.1 |
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 for the third quarter 2025.
3Corresponding USD amounts for each period are derived using FX rates from the Swedish Riksbank's website.
CEO Comments
ASPIRE is on track to complete enrollment in the first half of 2026, with continued enthusiasm fueled by new data supporting buloxibutid's disease-modifying signal in the Phase 2a AIR trial.
A quarter of focused trial execution and regulatory milestones
The third quarter was marked by disciplined execution as we continued to advance the global, randomized Phase 2b ASPIRE trial of buloxibutid in IPF. Our efforts remain centered on patient enrollment, bolstered by enthusiasm for buloxibutid's good tolerability profile in development to date and patient-friendly trial design. The trial is progressing well, with global enrollment on pace to goal, supported by positive feedback from investigators and participants. This momentum keeps us on track to complete enrollment in the first half of 2026.
The ASPIRE trial is designed to evaluate change in forced vital capacity (FVC) over 52 weeks, the registrational endpoint for IPF. Together with the team, I've spent considerable time visiting with our investigators and clinical sites and continue to be encouraged by the enthusiasm from investigators who recognize the significant potential of buloxibutid.
Buloxibutid also secured another regulatory milestone in September, as Japan's Ministry of Health, Labor and Welfare granted Orphan Drug designation to buloxibutid in IPF, an important recognition of its potential to address a significant unmet need. This designation complements our existing Orphan Drug designations in the US and EU, and the FDA Fast Track designation granted earlier this year, further strengthening the regulatory foundation for advancement of buloxibutid. In Japan, Vicore is developing buloxibutid in partnership with Nippon Shinyaku, ensuring strong local expertise and commercial capabilities in this key market.
IPF market momentum underscores opportunity
The IPF landscape saw notable developments this quarter, signaling renewed attention and investment in the field. Boehringer Ingelheim received FDA approval for Jascayd (nerandomilast) - the first new IPF therapy in over a decade - and United Therapeutics reported positive Phase 3 data for Tyvaso (treprostinil). This progress marks an important milestone for patients, signaling a renewed commitment to advancing IPF care and expanding available treatment options. These emerging therapies are expected to reduce lung function decline and offer differentiated tolerability profiles and, as a result, their arrival is likely to increase treatment rates and expand the IPF market. Despite these advances, a substantial unmet need remains for more effective and better tolerated therapies. Tyvaso's positive Phase 3 data also validates the role of vascular dysfunction in IPF, further supporting buloxibutid's mechanism of action.
Against this backdrop, buloxibutid stands out as the only emerging therapy with the potential to promote tissue repair while reducing inflammation, fibrosis, and vascular remodeling, offering the potential for a paradigm shift in IPF treatment.
Active engagement with clinicians continues to boost enthusiasm
The Vicore team has been busy this quarter engaging with clinicians globally and has been met with strong enthusiasm. At the ERS Congress in September, Vicore presented a synthetic control arm (SCA) analysis contextualizing the 36-week Phase 2a AIR trial results. Using SCAs generated from a large, real-world database of IPF patients, the analysis supported buloxibutid's beneficial treatment effect. Among patients with comparable baseline characteristics, buloxibutid showed statistically significant improvement in FVC (Forced Vital Capacity - a measure of lung capacity) at 36 weeks relative to synthetic control, confirming the disease-modifying signal observed in agoniststhe AIR trial. These findings reinforce the rationale for ASPIRE and have been well received in discussions with clinicians.
Looking ahead
As we enter the final quarter of the year, our focus remains on executing ASPIRE with quality and speed while continuing to engage with the clinical community and regulators. I am grateful to our employees, partners, investigators, and shareholders for their continued support - and to the patients and families who make this work possible.
With our work on ATRAGS, we are building a company with the potential to transform the treatment paradigm for IPF and unlock new treatments in severe fibrotic diseases.
Ahmed Mousa, CEO
Interim report, Q3 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)
ASPIRE is an ongoing global 52-week Phase 2b, randomized, double-blind, placebo-controlled clinical trial designed to assess the efficacy and safety of buloxibutid in IPF patients who are either not currently on treatment or receiving background nintedanib standard of care. Participants are randomized to receive one of two doses of buloxibutid (100 mg or 50 mg taken orally twice daily) or placebo. The primary endpoint is change from baseline in forced vital capacity, the registrational endpoint for IPF. Secondary endpoints include safety, tolerability, and the proportion of patients with disease progression over the trial period. The trial will enroll 270 patients from approximately 100 sites across 14 countries, including the United States.
The company's shares are listed on Nasdaq Stockholm's main market (VICO). www.vicorepharma.com
Attachments
Interim Report Q3 2025
SOURCE: Vicore Pharma Holding
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/biotechnology/interim-report-july-september-2025-1097232