STOCKHOLM, SE / ACCESSWIRE / November 05, 2024 /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 third quarter 2024.
"This past quarter was a pivotal period for Vicore, as we continue to make significant strides towards our long-term vision of improving treatment outcomes for patients suffering from idiopathic pulmonary fibrosis (IPF). Our most noteworthy achievements this quarter include the successful initiation of the global, randomized Phase 2b ASPIRE trial evaluating the disease-modifying potential of buloxibutid in IPF and the completion of a highly successful financing round just after the quarter close, which will ensure that we can successfully execute this important trial." Ahmed Mousa, CEO.
Significant events during the third quarter
In September at the 2024 European Respiratory Society Congress, Vicore delivered an oral presentation showcasing additional data from the Phase 2a AIR trial evaluating buloxibutid in idiopathic pulmonary fibrosis (IPF) and three poster presentations, including new preclinical data providing further evidence supporting buloxibutid's tissue repair mechanism.
In September, Vicore initiated the global, randomized Phase 2b ASPIRE trial evaluating the disease-modifying potential of buloxibutid in IPF following clearance by the US Food and Drug Administration (FDA) and other regulatory authorities.
In September, Vicore announced its intent to carry out a rights issue of approximately SEK 782 million (USD 75 million) to primarily finance the expanded Phase 2b ASPIRE trial, as well as Phase 3 preparatory activities. The rights issue was supported by current shareholders and new investors, including the global biopharmaceutical company Sanofi.
Significant events after the period
In October, Vicore announced the outcome of the rights issue, which was oversubscribed by ~33% and raised approximately SEK 782 million (USD 75 million) before issue costs. The raise was supported by current specialist investors, including HBM, HealthCap, and Invus, among others, as well as new investors including Sanofi, and will ensure that the company will be fully funded through the ASPIRE trial with additional cash runway.
In October, Vicore also carried out a directed share issue of approximately SEK 100 million (USD 10 million) at a subscription price of SEK 9.00 per new share, corresponding to a premium of approximately 18.3% to the closing price before the announcement. In addition to existing shareholder Invus, Capital Group, a new investor in Vicore, also participated in the directed share issue.
Financial overview for the period
July 1 - September 30, 2024
Net revenues amounted to SEK 0.0 million and SEK 0.0 million for the three months ended September 30, 2024 and 2023, respectively.
Operating loss amounted to SEK 60.1 million and SEK 65.1 million for the three months ended September 30, 2024 and 2023, respectively.
Loss amounted to SEK 60.0 million and SEK 63.6 million for the three months ended September 30, 2024 and 2023, respectively.
Loss per share, before and after dilution, amounted to SEK 0.54 and SEK 0.58 for the three months ended September 30, 2024 and 2023, respectively.
On September 30, 2024, cash, cash equivalents, and short-term investments amounted to SEK 380.4 million, equivalent to USD 38 million (SEK 482.8 million as of December 31, 2023).
January 1 - September 30, 2024
Net revenues amounted to SEK 104.2 million and SEK 0.0 million for the nine months ended September 30, 2024 and 2023, respectively.
Operating loss amounted to SEK 100.1 million and SEK 200.9 million for the nine months ended September 30, 2024 and 2023, respectively.
Loss amounted to SEK 84.6 million and SEK 199.1
million for the nine months ended September 30, 2024 and 2023, respectively.Loss per share, before and after dilution, amounted to SEK 0.76 and SEK 2.18 for the nine months ended September 30, 2024 and 2023, respectively.
Financial summary of the group
Amounts in SEK million | 2024 | 2023 | 2024 | 2023 | 2023 |
Net revenues (licensing income) | 0.0 | 0.0 | 104.2 | 0.0 | 0.0 |
Operating profit/(loss) | (60.1) | (65.1) | (100.1) | (200.9) | (321.5) |
Profit/(loss) for the period | (60.0) | (63.6) | (84.6) | (199.1) | (310.9) |
Profit/(loss) per share, before/after dilution (SEK)1 | (0.54) | (0.58) | (0.76) | (2.18) | (3.22) |
Research and development costs/operating costs (%)2 | 80.7 | 83.8 | 81.5 | 85.1 | 85.4 |
Equity at the end of the period | 377.7 | 566.5 | 377.7 | 566.5 | 455.4 |
Cash flow from operating activities | (87.3) | (35.4) | (113.8) | (182.1) | (249.6) |
Cash and cash equivalents and short-term | 380.4 | 551.5 | 380.4 | 551.5 | 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 interim report.
CEO Comments
"This past quarter was a pivotal period for Vicore, as we continue to make significant strides towards our long-term vision of improving treatment outcomes for patients suffering from idiopathic pulmonary fibrosis (IPF). Our most noteworthy achievements this quarter include the successful initiation of the global, randomized Phase 2b ASPIRE trial evaluating the disease-modifying potential of buloxibutid in IPF and the completion of a highly successful financing round just after the quarter close, which will ensure that we can successfully execute this important trial."
After the positive final results from the company's Phase 2a AIR trial were presented in May, which demonstrated that buloxibutid improves lung function over 36 weeks in IPF patients, the Vicore team has worked hard during the third quarter to advance the program into late-stage development.
After gaining clearance from the US FDA and other regulatory authorities in September, we initiated the global, randomized Phase 2b ASPIRE trial, marking a pivotal moment for the development of buloxibutid, a novel angiotensin II type 2 receptor agonist (ATRAG). The trial will enroll 270 patients across 14 countries, including the US, and will measure change from baseline in forced vital capacity (FVC) over 52-weeks, the registrational endpoint for IPF. This trial will have a global footprint and build on the promising results from our Phase 2a AIR trial, bringing us closer to our goal of providing a disease-modifying and well tolerated treatment option for IPF patients.
In September, Vicore initiated an ambitious financing round and we recently announced a successful raise of SEK 882 million (USD 85 million) via an oversubscribed rights issue and a directed share issue. This raise ensures that we will have the necessary resources to execute the expanded Phase 2b ASPIRE trial, conduct critical Phase 3 readiness activities, and meaningfully extend the company's cash runway following the conclusion of the study.
As a part of this financing round, we are thrilled to welcome Sanofi, one of the world's leading biopharmaceutical companies, and Capital Group, one of the world's largest investment management organizations, as new investors in Vicore. We are also encouraged by the strong support from our current specialist investors, including HBM, HealthCap, and Invus, among others.
In addition to our financing and clinical achievements, we were proud to present compelling new data on buloxibutid at the European Respiratory Society (ERS) Congress in Vienna this quarter. These presentations, spanning preclinical and clinical data, further validate buloxibutid's unique tissue-repair mechanism and its potential to make a significant impact on the lives of IPF patients.
Vicore continues to evaluate its novel early-stage ATRAGs and are considering several indications where the AT2 receptor plays a critical role and where these therapies could have a disease-modifying effect. The new funding gives us the flexibility to strengthen our pipeline and unlock the potential of our ATRAG platform in commercially attractive indications with high unmet need.
As we move into the final quarter of 2024, our main priority is to continue to activate clinical sites and enroll patients in the ASPIRE trial, while maintaining the highest standards of quality and efficiency.
I would like to extend my gratitude to our shareholders for their continued support, particularly during this recent financing, and to our dedicated team for their unwavering commitment to driving Vicore's mission forward. With strong momentum behind us, we are well-positioned to deliver on our goals and bring new hope to patients with IPF.
Ahmed Mousa
Interim report, Q3 2024 ; https://vicorepharma.com/investors/financial-reports/
For further information, please contact:
Hans Jeppsson, CFO, tel: +46 70 553 14 65, [email protected]
Megan Richards, VP of IR, Communications, and Portfolio Strategy, tel: +1 978 269-4372, [email protected]
This information was submitted for publication on November 5, 2024 at 08:00 CET.
About Vicore Pharma Holding AB (publ)
Vicore is a clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. The company is advancing a portfolio of therapies in respiratory and fibrotic diseases, including idiopathic pulmonary fibrosis (IPF). Buloxibutid (C21) is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) being investigated in a global Phase 2b trial in IPF. Almee™ is an investigational digital therapeutic in clinical development that is based on cognitive behavioral therapy and created to address the psychological impact of living with pulmonary fibrosis. Almee has received Breakthrough Device Designation from the FDA, which the Company believes reflects its potential to have transformative impact. Using its expertise in ATRAG chemistry and biology, Vicore is further developing its pipeline with several new therapies across additional indications. The company's shares are listed on Nasdaq Stockholm's main market (VICO). www.vicorepharma.com
Attachments
Interim Report Q3 2024
SOURCE: Vicore Pharma Holding