Vicore Pharma

Important events during the first quarter

• In January, Vicore announced discontinuation of the preclinical IMiD program to focus resources on advancing buloxibutid (C21) for patients with idiopathic pulmonary fibrosis (IPF).
• 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. to develop and commercialize buloxibutid 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.
• In March, Vicore announced FDA Breakthrough Device Designation for AlmeeTM.
• In March, Vicore announced an oral late-breaking presentation of the final results from the Phase 2a AIR trial of buloxibutid in IPF, to be presented at the 2024 American Thoracic Society International Conference in May.

Important events after the period

• No important events occurred after the period.

Financial overview for the period
January 1 - March 31, 2024

• Net revenues amounted to SEK 104.2 million and SEK 0.0 million for the three months ended March 31, 2024 and 2023, respectively.
• Operating profit/(loss) amounted to SEK 23.2 million and (SEK 66.1 million) for the three months ended March 31, 2024 and 2023, respectively.
• Profit/(loss) amounted to SEK 31.7 million and (SEK 66.3 million) for the three months ended March 31, 2024 and 2023, respectively.
• Profit/(loss) per share, before and after dilution, amounted to SEK 0.28 and (SEK 0.81) for the three months ended March 31, 2024 and 2023, respectively.
• On March 31, 2024, cash, cash equivalents, and short-term investments amounted to SEK 512.2 million, equivalent to USD 48.0 million (SEK 482.8 million as of December 31, 2023).

Financial summary of the group

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 17 in the interim report.

CEO Comments

During the first quarter, we continued to advance our Phase 2a AIR study of
buloxibutid in patients suffering from idiopathic pulmonary fibrosis (IPF), with the final patient‘s last visit completed. Since the quarter ended, we announced that we will be presenting the final Phase 2a AIR data in an oral late-breaking presentation at the ATS (American Thoracic Society) conference on May 19th.

The first quarter of 2024 was an eventful time at Vicore, which was highly focused on advancing our drug candidate for patients with IPF, buloxibutid (C21). We started the year with Bertil Lindmark, MD, PhD, joining as our new Chief Medical Officer, a highly experienced respiratory drug developer with a record of significant drug approvals. In February, we announced a regional partnership for buloxibutid in Japan with Nippon Shinyaku, providing further validation of the exciting potential of this therapy, accelerating development in that country, and bringing non-dilutive capital in the form of upfront, milestone, and research and development expense payments. In addition, we continued to advance our Phase 2a AIR study of buloxibutid in patients suffering from IPF, with the final patient‘s last visit completed in the first quarter. Since the quarter ended, we announced that we will be presenting the final Phase 2a AIR data in an oral late-breaking presentation at the ATS (American Thoracic Society) conference on May 19th. We also continue progressing towards initiating our Phase 2b ASPIRE study of buloxibutid in patients with IPF. Beyond our progress with buloxibutid, we were pleased to announce the receipt of breakthrough device designation from the US Food and Drug Administration for our digital therapy for anxiety associated with pulmonary fibrosis, AlmeeTM.

The partnership with Nippon Shinyaku to develop and commercialize buloxibutid in Japan is proceeding according to plan. 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. Importantly, this agreement allows Vicore to retain the rights to develop and commercialize buloxibutid in all markets outside Japan. Vicore has received an upfront payment of USD 10 million and is entitled to up to USD 275 million in milestones, along with tiered royalty payments up to the low 20s. We look forward to collaborating with Nippon Shinyaku and will share more details on the progress in coming reports.

The phase 2b ASPIRE study will be a 52-week randomized, double-blind, placebo-controlled, parallel-group, multicentre trial of two doses of buloxibutid. The aim is to include 270 patients (90 per treatment arm) with IPF, either not treated with antifibrotics or on stable nintedanib therapy. The primary endpoint will be a change from the baseline in FVC (forced vital capacity). We have been working closely with patients, patient organizations, our advisory committee, and clinical experts within the respiratory field to develop the best possible study design.

We are also working actively on development paths for AlmeeTM, our digital therapeutic treating anxiety in pulmonary fibrosis. The results from the pivotal study COMPANION showed a clear clinical benefit compared to the control group, with a significant reduction in anxiety among patients with pulmonary fibrosis. The results are outstanding and show how important this tool can be in supporting the patients' need for psychological support during a difficult disease. COMPANION enrolled 108 participants from across the United States in a randomized, controlled, parallel-group clinical investigation evaluating its impact on anxiety and quality of life in adults diagnosed with pulmonary fibrosis. We believe that AlmeeTM has great potential to positively impact patients suffering from anxiety associated with pulmonary fibrosis, including in combination with molecular therapies.

In parallel, Vicore continues evaluating novel angiotensin II type 2 receptor agonists (ATRAGs) in our early development programs. These ATRAGs could be developed in other indications where the AT2 receptor plays a central role and we are currently reviewing several indications where we believe this mechanism may have a disease-modifying effect and be well suited for treatment with our ATRAG molecules.

I want to express my gratitude to our employees, patients and patient organizations, advisors, partners, and shareholders for their continued support and trust. We are convinced of the need to develop buloxibutid for IPF and look forward to continuing this journey together with all of you.

Ahmed Mousa

Interim report, Q1 2024:
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 May 3 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). Buloxibutid (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. Almee has received Breakthrough Device Designation from the FDA, reflecting its potential to have transformative impact. 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.