STOCKHOLM, SWEDEN / ACCESS Newswire / February 27, 2025 / Vicore Pharma Holding (STO:VICO) Stockholm, February 27, 2025 - Vicore Pharma Holding AB (STO:VICO) ("Vicore"), unlocking the potential of a novel class of drugs, angiotensin II type 2 receptor agonists (ATRAGs), today published the year-end report for 2024.
"The fourth quarter was another pivotal period for Vicore as the company successfully raised over SEK 880 million (USD ~85 million) in financing transactions, while ramping up the global, randomized Phase 2b ASPIRE trial evaluating the disease-modifying potential of buloxibutid in IPF. As a result of this successful financing, we now have the necessary funding to execute this clinically meaningful late-stage trial, bringing us one step closer to delivering an innovative treatment option for patients suffering from IPF." Ahmed Mousa, CEO
Significant events during the fourth quarter
Vicore announced the completion and outcome of the rights issue financing in October. The transaction was heavily oversubscribed (by over 30%) and raised approximately SEK 782 million (USD ~76 million) before transaction costs. The financing was supported by current specialist investors, including HBM, HealthCap, and Invus, among others, as well as new investors including Sanofi, and was designed to ensure that the company will be funded through the next major inflection point with additional cash runway.
In addition to the rights issue financing, Vicore carried out a directed share issue to raise approximately SEK 100 million (USD ~10 million) at SEK 9.00 per share, a premium of over 18% to the closing price prior to the announcement. In addition to existing shareholder Invus, Capital Group, a new investor in Vicore, participated in the transaction.
Significant events after the period
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).
Financial overview for the period
October 1 - December 31, 2024
Net revenues amounted to SEK 5.1 million and SEK 0.0 million for the three months ended December 31, 2024 and 2023, respectively.
Operating loss amounted to SEK 94.1 million and SEK 120.6 million for the three months ended December 31, 2024 and 2023, respectively.
Loss amounted to SEK 84.1 million and SEK 111.9 million for the three months ended December 31, 2024 and 2023, respectively.
Loss per share, before and after dilution, amounted to SEK 0.40 and SEK 0.99 for the three months ended December 31, 2024 and 2023, respectively.
On December 31, 2024, cash, cash equivalents, and short-term investments amounted to SEK 1,156.0 million, equivalent to USD 105 million (SEK 482.8 million as of December 31, 2023).
January 1 - December 31, 2024
Net revenues amounted to SEK 109.4 million and SEK 0.0 million for the year ended December 31, 2024 and 2023, respectively.
Operating loss amounted to SEK 194.2 million and SEK 321.5 million for the year ended December 31, 2024 and 2023, respectively.
Loss amounted to SEK 168.6 million and SEK 310.9.
million for the year ended December 31, 2024 and 2023, respectively.Loss per share, before and after dilution, amounted to SEK 1.23 and SEK 3.18 for the year ended December 31, 2024 and 2023, respectively.
The Board of Directors proposes to the Annual General Meeting that no dividend be paid for the financial year 2024.
Financial summary of the group
Amounts in SEK million |
| 2024 |
|
| 2023 |
|
| 2024 |
|
| 2023 |
| ||||
Net revenues (licensing income) |
|
| 5.1 |
|
|
| 0.0 |
|
|
| 109.4 |
|
|
| 0.0 |
|
Operating profit/(loss) |
|
| (94.1 | ) |
|
| (120.6 | ) |
|
| (194.2 | ) |
|
| (321.5 | ) |
Profit/(loss) for the period |
|
| (84.1 | ) |
|
| (111.9 | ) |
|
| (168.6 | ) |
|
| (310.9 | ) |
Profit/(loss) per share, before/after dilution (SEK)1 |
|
| (0.40 | ) |
|
| (0.99 | ) |
|
| (1.23 | ) |
|
| (3.18 | ) |
Research and development costs/ operating costs (%)2 |
|
| 82.2 |
|
|
| 85.8 |
|
|
| 81.7 |
|
|
| 85.4 |
|
Equity at the end of the period |
|
| 1,129.3 |
|
|
| 455.4 |
|
|
| 1,129.3 |
|
|
| 455.4 |
|
Cash flow from operating activities |
|
| (51.2 | ) |
|
| (67.5 | ) |
|
| (165.0 | ) |
|
| (249.6 | ) |
Cash and cash equivalents and short-term investments at the end of the period |
|
| 1,156.0 |
|
|
| 482.8 |
|
|
| 1,156.0 |
|
|
| 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 18 in the year-end report.
CEO Comments
"The fourth quarter was another pivotal period for Vicore as the company successfully raised over SEK 880 million (USD ~85 million) in financing transactions, while ramping up the global, randomized Phase 2b ASPIRE trial evaluating the disease-modifying potential of buloxibutid in IPF. As a result of this successful financing, we now have the necessary funding to execute this clinically meaningful late-stage trial, bringing us one step closer to delivering an innovative treatment option for patients suffering from IPF."
During the quarter, we were pleased to close a series of successful financing transactions to raise over SEK 880 million (USD ~85 million), bringing our cash balance to SEK 1,156 million (USD 105 million) at the end of 2024.
We were grateful to have the support of new and existing investors in our transaction who are among the world's leading healthcare specialists and institutional investors, including HBM, the Fourth Swedish Pension Fund (AP4), Invus, HealthCap, Capital Group, and many others. We were also delighted to welcome Sanofi, one of the world's leading biopharmaceutical companies, as an investor in Vicore.
This new funding strengthens the company's institutional shareholder base and demonstrates the belief that leading funds and corporates have in Vicore and the transformative potential of our strategy. The proceeds from this ambitious financing put us in a strong position to execute on our ongoing Phase 2b ASPIRE trial to confirm buloxibutid's disease-modifying potential in IPF, while meaningfully extending the company's cash runway following the conclusion of the study. Furthermore, we will be able fund critical Phase 3 readiness activities and expand and accelerate the development of our angiotensin II type 2 receptor agonist (ATRAG) platform. This will further establish Vicore's position in IPF, as well as in other attractive indications with high unmet need.
Our efforts in the final quarter build on our activities earlier in 2024, including disclosure of positive results from the Phase 2a AIR trial, where buloxibutid demonstrated excellent safety, tolerability, and efficacy. Over 36 weeks of treatment, buloxibutid improved lung function, measured by forced vital capacity (FVC), with a significant effect over expected decline in untreated patients. In untreated patients, a decline corresponding to approximately 180 mL over 36 weeks has been reported.
In patients enrolled in the AIR trial, FVC increased by an average of 216 mL from baseline to week 36, nearly 400 mL over the untreated trajectory.
To confirm these groundbreaking results, the company initiated the Phase 2b ASPIRE trial in the third quarter of 2024. This global, 52-week study aims to further evaluate the efficacy and safety of buloxibutid in IPF. ASPIRE will enroll 270 patients across 14 countries, including the United States, and will allow patients to remain on background nintedanib standard of care therapy. The primary endpoint is change from baseline in FVC, and the trial design has been developed in collaboration with leading pulmonologists, patient advocacy groups, and an advisory panel of IPF patients and caregivers. While in early stages, the ASPIRE trial is progressing, actively enrolling and dosing patients, thanks to successful interactions with regulators and enthusiasm and dedication from clinical sites.
In January, the FDA granted Fast Track designation (FTD) to buloxibutid, underscoring its potential as a disease-modifying therapy for IPF. FTD is designed to expedite the development of drugs that address unmet medical needs in serious or life-threatening diseases. This designation underscores the potential of buloxibutid to offer a significant improvement over existing treatments, as demonstrated by available clinical and non-clinical data. Vicore plans to leverage the benefits of FTD which include more frequent communications with FDA as well as the potential for Accelerated Approval and Priority Review.
The Vicore team demonstrated exceptional dedication throughout the past year, and it is gratifying to receive recognition for these efforts. This includes winning the 2024 SwedenBIO Award for our commitment to addressing unmet medical needs and advancing our programs as a tangible demonstration of that commitment.
With the recent funding and the continued progress of the Phase 2b ASPIRE trial, Vicore is in a strong position as we kick off 2025. We have a clear strategy to advance buloxibutid through late-stage clinical development and remain focused on executing this plan. I want to express my sincere gratitude to the entire Vicore team for their dedication and to our investors for their continued confidence in our science and mission.
Most importantly, I extend my deepest appreciation to the patients who have participated in our trials and to those currently enrolling in ASPIRE, whose commitment is essential in bringing this potentially disease-modifying treatment to market.
Ahmed Mousa
Year-end report 2024; 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 is publicly listed on the Nasdaq Stockholm exchange (VICO).?www.vicorepharma.com
Attachments
Year End Report 2024 ENG
SOURCE: Vicore Pharma Holding
View the original press release on ACCESS Newswire
