Important events during the third quarter

• In July, Vicore announced that Ahmed Mousa has been appointed as the new CEO starting on September 9.
• In July, Vicore established a wholly-owned US subsidiary, Vicore Pharma US Inc.
• In August, Vicore announced the results of the exploratory trial using EndoPAT®, as a tool to assess the effect of C21 on endothelial function. Results were inconclusive due to high intra-individual variability.
• In September, Vicore announced the presentation of two posters on its lead program, C21, at the European Respiratory Society (ERS) International Congress in Milan, Italy.

Important events after the period

• In October, Vicore announced the results from the phase 1 study of C106. Further development of the program will be 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.

Financial overview for the period

July 1 - September 30, 2023

• Net sales amounted to SEK 0.0 million and SEK 0.0 million for the three months ended September 30, 2023 and 2022, respectively.
• Operating loss amounted to SEK 65.1 million and SEK 69.7 million for the three months ended September 30, 2023 and 2022, respectively.
• Loss amounted to SEK 63.6 million and SEK 68.5 million for the three months ended September 30, 2023 and 2022, respectively.
• Loss per share, before and after dilution, amounted to SEK 0.58 and SEK 0.95 for the three months ended September 30, 2023 and 2022, respectively.
• On September 30, 2023, cash, cash equivalents, and short-term investments amounted to SEK 551.5 million equivalent to USD 50.7 million (SEK 261.7 million as of December 31, 2022).

January 1 - September 30, 2023

• Net sales amounted to SEK 0.0 million and SEK 0.0 million for the nine months ended September 30, 2023 and 2022, respectively.
• Operating loss amounted to SEK 200.9 million and SEK 227.7 million for the nine months ended September 30, 2023 and 2022, respectively.
• Loss amounted to SEK 199.1 million and SEK 227.7 million for the nine months ended September 30, 2023 and 2022, respectively.
• Loss per share, before and after dilution, amounted to SEK 2.18 and SEK 3.17 for the nine months ended September 30, 2023 and 2022, respectively.

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

“C21 has the potential to transform the treatment landscape for individuals suffering from idiopathic pulmonary fibrosis (IPF). Vicore’s deep understanding of the angiotensin pathway has translated into an upstream intervention - the right approach for this complex disease. These efforts are bearing fruit with the impressive Phase 2a AIR study[1], demonstrating C21 is safe and well-tolerated, along with exhibiting an exciting efficacy signal.”

I’m very pleased to be joining the Vicore team at this important time in the company’s history. Under the leadership of Carl-Johan Dalsgaard, Vicore has built an impressive understanding of the angiotensin pathway. This expertise is demonstrated in clinical results for our lead molecule, C21, which modulates an upstream target in a safe and well-tolerated manner based on clinical data to date. In addition, the efficacy of C21 on lung function over 36 weeks for individuals suffering from IPF is striking, demonstrating a clinical signal and the potential to offer a truly unique therapy for this terrible disease. I’m looking forward to applying my experience in the biotechnology sector, including business and corporate development, intellectual property, and portfolio strategy to build upon these successes for the company. I’m also looking forward to expanding the global footprint of the company, including in the United States, as we prepare for late-stage clinical development.

Our team’s main focus is creating meaningful impact for patients suffering from IPF; the Phase 2a AIR study of C21 in IPF will soon conclude and final results are expected in the first half of next year. In addition, we are actively planning for the initiation of the Phase 2b ASPIRE study of C21 in IPF. ASPIRE will be a global, double-blind, placebo-controlled, study with a 52-week treatment duration and remains on track to start in the first half of 2024.

We are also looking forward to disclosing topline results from the pivotal COMPANION study[2], of our digital therapy AlmeeTM for the treatment of anxiety in individuals suffering from pulmonary fibrosis later this year.

In October, we provided an update regarding the Phase 1 study of C106[3]. While no major safety signal was observed in this study, there was transient increase in blood pressure reported at higher doses that represents a challenge to further development. The learnings from C106 will be leveraged to advance our follow-on ATRAGs. Preclinical characterization to date reflects that these follow-on programs have favorable properties.

In September, the Vicore team attended the European Respiratory Society’s 2023 International Congress where we gave two presentations related to our C21 program and took the opportunity to meet with a range of clinical experts, key opinion leaders and other stakeholders. As C21 advances to late-stage development, we are heartened to see a broad range of interest in this exciting program in the clinical community.

We look forward to continuing the development of C21 and our other programs and I would like to thank Vicore’s stakeholders for making these efforts possible.

Ahmed Mousa

Interim report July-September, 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 November 2, 2023 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 drug candidates to stop disease progression and restore function. The company is establishing a portfolio in rare lung diseases including idiopathic pulmonary fibrosis (IPF) and pulmonary arterial hypertension (PAH). C21 is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in a phase 2a study of IPF. C21 is protected by US and European orphan drug designation. A variety of patents have been filed to provide further protection for C21, out to 2040 and onwards. Almee™ (an investigational medical device in clinical development) is a digital therapeutic (DTx) based on cognitive behavioral therapy (CBT) created to address the psychological impact of living with pulmonary fibrosis. Inhaled IMID is a new formulation and delivery route of thalidomide targeting the severe cough associated with IPF. Using its unique expertise in the ATRAG biology Vicore is further fueling its pipeline with several new small molecule drug assets, with long patent life and for a variety of indications, some of which could be partnered while others may be taken to the market by Vicore. The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com. 

[1] NCT04533022
[2] NCT05330312
[3] NCT05427253