Interim Report January – March 2025
STOCKHOLM, SE / ACCESS Newswire / May 6, 2025 /Vicore Pharma Holding AB (STO:VICO) ("Vicore"), unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), publishes the interim report for first quarter 2025.
"As we conclude the first quarter of 2025, I am proud to reflect on Vicore Pharma 's focused execution and unwavering commitment to advancing a potentially disease-modifying treatment for IPF. This quarter was a period of operational momentum as we continued to activate sites and enroll patients in our global Phase 2b ASPIRE trial. Our team 's dedication to scientific innovation and patient-centric research remains the driving force behind our progress." Ahmed Mousa, CEO
Significant events during the first quarter
In January, the United States Food and Drug Administration (FDA) granted Fast Track designation (FTD) to buloxibutid, recognizing its disease-modifying potential for the treatment of idiopathic pulmonary fibrosis (IPF).
In March, it was decided that INIM Pharma AB will merge with its parent company, Vicore Pharma Holding AB.
Significant events after the period
No significant events occurred after the first quarter.
Financial overview for the period
January 1 - March 31, 2025
Revenue amounted to SEK 0.9 million and SEK 104.2 million for the three months ended March 31, 2025 and 2024, respectively.
Operating profit/(loss) amounted to (SEK 91.5 million) and SEK 23.2 million for the three months ended March 31, 2025 and 2024, respectively.
Profit/(loss) for the period amounted to (SEK 111.5 million) and SEK 31.7 million for the three months ended March 31, 2025 and 2024, respectively.
Profit/(loss) per share, before and after dilution, amounted to (SEK 0.48) and SEK 0.28 for the three months ended March 31, 2025 and 2024, respectively.
On March 31, 2025, cash, cash equivalents, and short-term investments amounted to SEK 1,048.8 million, equivalent to USD 104.6 million (SEK 1,156.0 million as of December 31, 2024).
Financial summary of the group
Amounts in SEK million | 2025 | 2024 | 2024 |
Revenue | 0.9 | 104.2 | 109.4 |
Operating profit/(loss) | (91.5) | 23.2 | (194.2) |
Profit/(loss) for the period | (111.5) | 31.7 | (168.6) |
Profit/(loss) per share, before/after dilution (SEK) 1 | (0.48) | 0.28 | (1.23) |
Research and development costs/operating costs (%) 2 | 84.3 | 84.0 | 81.7 |
Equity at the end of the period | 1,020.3 | 488.8 | 1,129.3 |
Cash flow from operating activities | (86.1) | 23.1 | (165.0) |
Cash and cash equivalents and short-term investments at the end of the period | 1,048.8 | 512.2 | 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
"As we conclude the first quarter of 2025, I am proud to reflect on Vicore Pharma 's focused execution and unwavering commitment to advancing a potentially disease-modifying treatment for IPF. This quarter was a period of operational momentum as we continued to activate sites and enroll patients in our global Phase 2b ASPIRE trial. Our team 's dedication to scientific innovation and patient-centric research remains the driving force behind our progress."
In January, buloxibutid, a novel angiotensin II type 2 receptor agonist (ATRAG), was granted FTD by the FDA, reinforcing its potential to significantly improve outcomes for patients living with IPF. FTD is designed to expedite the development of drugs that address unmet medical needs in serious or life-threatening diseases. This designation not only facilitates a more efficient development path but also underscores the growing recognition of buloxibutid 's potential to offer a meaningful improvement over existing treatments. It also reflects our deep commitment to addressing the urgent, unmet need in this devastating disease.
Following regulatory clearances from the FDA and other global regulatory authorities in September 2024, we initiated the global, randomized Phase 2b ASPIRE trial, marking a pivotal moment for the development of buloxibutid in IPF. The trial is enrolling 270 patients across 14 countries, including the US, and is designed to evaluate the change from baseline in forced vital capacity (FVC) over 52-weeks, the registrational endpoint for IPF. With regulatory approvals secured in all 14 participating countries, patient recruitment remains our highest priority. Over the past quarter, our team has been deeply focused on execution of this trial, with ongoing site activations and frequent and meaningful site engagement globally.
Site activation in ASPIRE is progressing well, with 75% of the sites now active. We are also pleased with the progress in screening and patient enrollment. We are seeing strong interest in the trial, buoyed by the limited number of programs in later-stage development for IPF, the tolerability profile of the drug candidate to date, and the patient-friendly trial design.
To support this next phase of growth, we 've expanded and strengthened our senior clinical leadership with the appointments of Dr. Bernt van den Blink as VP of Clinical Development and Jonathan Langley as Head of Global Medical Affairs. Both bring deep expertise and proven track records in advancing global clinical programs in IPF. Their leadership will be critical as we accelerate site activation, drive patient enrollment, and ensure seamless execution of the ASPIRE trial across our global footprint. I 've had the opportunity to work alongside them in the field, visiting clinical sites and engaging with investigators - efforts that are building real momentum for the trial and expanding awareness of Vicore 's broader potential in IPF. Looking ahead, we are excited to continue engaging with the scientific community.
During the first quarter, we also participated in several global banking conferences to connect with new and existing investors, and we look forward to maintaining that momentum this spring. We are excited to have been selected to present Vicore data in multiple oral presentations and posters at the American Thoracic Society (ATS) International Conference in May, which will provide the opportunity to engage with respiratory experts and discuss advancements in the field. Thanks to the successful capital raise in late 2024, we remain in a strong financial position to execute on the Phase 2b ASPIRE trial and prepare for critical-path Phase 3 readiness activities, such as drug manufacturing.
As Vicore dynamically moves into the next phase, I am reminded of our purpose. IPF is a relentless and life-limiting disease that leaves patients and families with few options. Our ambition is to change that. I would like to thank and extend my gratitude to our partners and shareholders for their continued support, our dedicated team for their unwavering commitment, and most importantly, to the patients who continue to participate in our clinical trials and whose involvement is essential in bringing potentially life-changing therapies to the broader market.
Ahmed Mousa
CEO
Interim report, Q1 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
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 is publicly listed on the Nasdaq Stockholm exchange (VICO).www.vicorepharma.com
Attachments
Interim Report 1 Jan 31 Mar 2025
SOURCE: Vicore Pharma Holding
View the original press release on ACCESS Newswire
© 2025 ACCESS Newswire. All Rights Reserved.
