Important events during the fourth quarter

• In October, Vicore announced the results from the Phase 1 study of C106. Further development of the program has been discontinued due to a transient increase in blood pressure observed at doses believed to be in the clinically effective range. The development of C21 continues as planned and no blood pressure signal has been observed in its clinical trials. An impairment of intangible assets amounting to SEK 12 million impacted research and development costs during the third quarter, but has not impacted on cash flow.
• In December, Vicore appointed Dr. Bertil Lindmark MD, PhD, as new Chief Medical Officer.

Important events after the period

• In January, Vicore announced that the preclinical IMiD program will be discontinued to focus resources on advancing C21 in IPF. An impairment of intangible assets amounting to SEK 50.5 million impacted research and development costs during the fourth quarter, but has no impact on cash flow.
• In January, Vicore reported positive results in the pivotal study of AlmeeTM, a digital therapeutic for the treatment of anxiety in pulmonary fibrosis.
• In February, Vicore announced an exclusive license agreement with Nippon Shinyaku Co. Ltd. for the development and commercialization of C21 for idiopathic pulmonary fibrosis (IPF) in Japan. Vicore will receive an upfront payment of USD 10 million and is entitled to up to USD 275 million in milestones in addition to tiered royalty payments into the low 20s.

Financial overview for the period

October 1 - December 31, 2023

• Net sales amounted to SEK 0.0 million and SEK 0.0 million for the three months ended December 31, 2023 and 2022, respectively.
• Operating loss amounted to SEK 120.6 million and SEK 63.0 million for the three months ended December 31, 2023 and 2022, respectively.
• Loss amounted to SEK 111.9 million and SEK 60.7 million for the three months ended December 31, 2023 and 2022, respectively.
• Loss per share, before and after dilution, amounted to SEK 1.00 and SEK 0.83 for the three months ended December 31, 2023 and 2022, respectively.
• On December 31, 2023, cash, cash equivalents, and short-term investments amounted to SEK 482.8 million equivalent to USD 48.1 million (SEK 261.7 million as of December 31, 2022).

January 1 - December 31, 2023

• Net sales amounted to SEK 0.0 million and SEK 0.0 million for the year ended December 31, 2023 and 2022, respectively.
• Operating loss amounted to SEK 321.5 million and SEK 290.7 million for the year ended December 31, 2023 and 2022, respectively.
• Loss amounted to SEK 310.9 million and SEK 288.4 million for the year ended December 31, 2023 and 2022, respectively.
• Loss per share, before and after dilution, amounted to SEK 3.22 and SEK 3.99 for the year ended December 31, 2023 and 2022, respectively.
• The Board of Directors proposes to the Annual General Meeting that no dividend be paid for the financial year 2023

Financial summary of the group

1 There is no dilution effect for potential ordinary shares for periods where earnings have been negative.
2 Alternative performance measure (APM). Defined on page 17 in the interim report.

CEO Comments

"I am delighted with our recently announced strategic partnership with Nippon Shinyaku for the development and commercialization of C21 in Japan. This agreement marks a significant step forward in our mission to bring a potentially transformative therapy to patients suffering from IPF."

The fourth quarter of 2023 and start of 2024 has been an exciting time for Vicore with confirmation of our focus on development of C21 for idiopathic pulmonary fibrosis (IPF) as well as the timelines for Phase 2a AIR study completion and Phase 2b ASPIRE study initiation, announcement of a partnership for the development of C21 in Japan with a highly respected biopharmaceutical company, and announcement of positive pivotal data for our digital therapy, AlmeeTM, to provide psychological support for individuals suffering from pulmonary fibrosis.

I am delighted with our recently announced strategic partnership with Nippon Shinyaku for the development and commercialization of C21 in Japan. This agreement marks a significant step forward in our mission to bring a potentially transformative therapy to patients suffering from IPF.

Under this collaboration, Vicore will receive an upfront payment of USD 10 million and is entitled to milestone payments totaling about USD 275 million, along with tiered royalty payments up to the low 20s. This partnership not only validates the potential of C21, but also provides critical financial support for our ongoing efforts in advancing innovative treatments for IPF.

Nippon Shinyaku is a distinguished biopharmaceutical company with a strong presence in the Japanese market. Their commitment and expertise in drug development for rare diseases make them an ideal collaborator as we work towards bringing C21 to patients in this region and across the globe.

Importantly, this agreement allows Vicore to retain the rights to develop and commercialize C21 in all markets outside of Japan, providing us with the flexibility to explore and expand the therapeutic potential of C21 globally.

This collaboration exemplifies our commitment to advancing transformative therapies for IPF and ensuring that patients worldwide have access to groundbreaking treatments. We are excited about the prospects of this partnership and its ability to advance and accelerate the development of C21 in Japan.

We were thrilled to share early this year that the COMPANION pivotal study met its primary endpoint with the AlmeeTM digital therapy, demonstrating a significant reduction in anxiety among patients with pulmonary fibrosis. This is a remarkable milestone, showcasing the effectiveness of AlmeeTM as the first digital therapy designed to address the psychological challenges associated with living with pulmonary fibrosis. The study enrolled 108 participants from across the United States in a randomized, controlled, parallel-group clinical investigation evaluating its impact on the anxiety and quality of life in adults diagnosed with pulmonary fibrosis. Living with a deadly disease for which there is currently no curative treatment available has a negative impact on mental health and quality of life, the aim of AlmeeTM is to provide personalized and accessible psychological support for these patients. Vicore plans to present full results from the COMPANION study at a medical conference later this year. We will seek to advance AlmeeTM in partnership with pharmaceutical companies having approved or late-stage molecular therapies for the treatment of pulmonary fibrosis, spearheading innovation in improved therapy with digital-molecular combination therapies.

Our commitment to advancing innovative treatments for IPF remains unwavering. The development of C21 for IPF is progressing as planned, with final Phase 2a AIR data expected in the first half of 2024 and the initiation of ASPIRE, a global, double-blind, placebo-controlled, 52-week, Phase 2b study of C21 for IPF in the same timeframe.

As we transition to late-stage development of C21 in IPF, the focus on our pipeline has intensified. The decision to discontinue the preclinical IMiD program reflects our strategic commitment to allocate resources where they can have the most significant impact. This shift underscores our dedication to advancing therapies that make a meaningful difference in the lives of patients facing pulmonary fibrosis.

While we concentrate on the late-stage development of C21 in IPF, we are concurrently reviewing opportunities for follow-on indications and AT2 receptor agonists to complement this progress. Our goal is to continue expand our impact, address unmet needs, and explore avenues that align with our commitment to innovation and patient-centric solutions.

We were pleased to announce a significant development in Vicore's leadership team late last year as we continue to reinforce our position as a leader in IPF drug development. Dr. Bertil Lindmark, with his extensive expertise in late-stage clinical development for respiratory diseases, including IPF, has joined us as the new Chief Medical Officer. His notable contributions to the development of global respiratory brands, including Symbicort, make him an invaluable addition to our team.

We look forward to the next phase of development, confident that under his guidance, we will continue to make significant strides in addressing the challenges faced by patients with IPF.

Our success is built on the collective efforts of our exceptional team. I want to express my gratitude to each and every employee for their hard work and dedication. Their commitment to our mission is the driving force behind our achievements, and together, we will continue to reach new heights.

Ahmed Mousa
CEO

Year-end report, 2023; https://vicorepharma.com/investors/financial-reports/

For further information, please contact:
Ahmed Mousa, CEO, tel: +1 607 437-0235, ahmed.mousa@vicorepharma.com  
Hans Jeppsson, CFO, tel: +46 70 553 14 65, hans.jeppsson@vicorepharma.com

This information was submitted for publication on February 28 2024 at 08:00 CET.

About Vicore Pharma Holding AB (publ)
Vicore is an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. The company is establishing a portfolio in respiratory diseases, including idiopathic pulmonary fibrosis (IPF). C21 is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in phase 2a development for IPF. Almee™ (an investigational medical device in clinical development) is a digital therapeutic based on cognitive behavioral therapy created to address the psychological impact of living with pulmonary fibrosis. Using its unique expertise in ATRAG chemistry and biology, Vicore is further fueling its pipeline with several new therapies across additional potential indications. The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see  www.vicorepharma.com.