Interim report April - June 2022

Gothenburg, August 25, 2022 - Vicore Pharma Holding AB (publ) publishes the interim report for the second quarter 2022.

Important events during the second quarter

• In April, Vicore announced that the first patient in the clinical investigation of the digital therapeutic (DTx) in IPF was enrolled.
• In April, Vicore submitted a clinical trial application (CTA) to start a phase 1 trial with the new drug candidate (C106) from the VP03 program.
• In June, Vicore announced an amendment of the primary endpoint to all-cause mortality and a reduced sample size in the phase 3 trial in COVID-19. Read-out is expected during Q3 2022.
• In June, Vicore announced that the first subject was dosed in the phase 1 trial with C106.
• In June, Vicore resolved on a set-off issue of 87,686 shares and a total of 3 MSEK in cash as part of a milestone compensation to Emeriti Bio and HaLaCore for the start of the phase 1 trial with C106.

Important events after the period

• In August, Vicore announced that the IPF interim data was selected as an oral late breaker at the ERS congress.

Financial overview for the period
April 1 – June 30, 2022

• Net sales amounted to 0.0 MSEK (0.0)
• The operating loss was -64.9 MSEK (-68.4)
• Loss for the period amounted to -65.9 MSEK (-70.4)
• Loss per share, before and after dilution, was -0.92 SEK (-0.98)
• On June 30, 2022, cash, cash equivalents and short-term investments amounted to 236.6 MSEK (371.5 MSEK as of December 31, 2021)

January 1 - June 30, 2022      

• Net sales amounted to 0.0 MSEK (0.0)
• The operating loss was -158.0 MSEK (-116.0)
• Loss for the period amounted to -159.2 MSEK (-118.5)
• Loss per share, before and after dilution, was -2.22 SEK (-1.75)

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 20 in the interim report.

CEO Comments

The emergence of the next generation of ATRAGs (angiotensin II type 2 receptor agonists) is an important signal of the transformation that we are currently implementing at Vicore. The early clinical data of C21 not only open an avenue for pioneering ATRAGs in severe lung diseases such as IPF, but also act as a pathfinder for the ATRAGs, an entirely new class of drugs around which Vicore has accumulated highly valuable clinical experience, is pursuing significant intellectual property protection, all supported by a broad-ranging matrix of supporting technology.

In the second quarter of 2022, Vicore’s progress continued with the company leveraging its substantial body of clinical experience and knowledge accumulated through work on C21. This includes treatment of severe lung diseases and the development of angiotensin II type 2 receptor agonists (ATRAGs) across a broader range of conditions.

The company is currently anticipating several clinical milestones in the second half of 2022. As previously announced, Vicore has worked closely with international regulatory authorities to alter the design of its phase 3 ATTRACT-3 clinical trial of C21 in the treatment of COVID-19 that requires hospitalization. Both the company and regulators have responded nimbly to the evolving profile of the COVID-19 pandemic, changing the primary endpoint of the ATTRACT-3 trial to all-cause mortality. This clarifies the clinical analysis and broadens the way in which the impact of C21 for COVID-19 patients is measured. We also agreed with regulators that it would be possible to reduce the number of patients that we need to recruit for the trial to approximately 300, roughly half the number in the original design. We now expect a topline read-out from ATTRACT-3 in the third quarter of 2022, after which the company will determine the next steps for C21 in COVID-19.

Vicore is also anticipating further maturation of the phase 2 AIR trial with C21 in idiopathic pulmonary fibrosis (IPF) following the promising interim findings we announced in February 2022. That interim analysis showed that lung function increased by a clinically meaningful degree in a high proportion of C21-treated patients. Over the next few months, and in consultation with key opinion leaders in IPF, Vicore will undertake a deep evaluation of both clinical and other underlying data from the AIR trial as a key component in the planning of the next trial with C21 in IPF.

Alongside the excitement of the interim results from AIR and the planning of the next trial, Vicore has embarked on COMPANION, a clinical study of the impact of our digital cognitive behavioral therapeutic, Almee^TM, in addressing the psychological symptom burden in adults diagnosed with severe fibrotic lung diseases, including IPF. The COMPANION study will take place in the US and will deploy cutting edge clinical approaches that allow patient inputs and assessments to be made on a highly decentralized basis. After a pilot phase that began in Q2 2022, COMPANION is now advancing towards the pivotal phase which is expected to conclude in 2023.

Our trials with C21 in COVID-19 and IPF have produced highly encouraging findings, indicating that an ATRAG like C21 can restore function to diseased lungs, whether the cause of the lung injury is long-term fibrosis or short-term viral infection. This success inspired another phase in Vicore’s progression, the expansion of our ATRAG program beyond C21 to a set of proprietary ‘next generation’ ATRAGs that the company will develop for other indications.

In June, we announced that the first healthy volunteer had been dosed with C106, the first angiotensin II type 2 receptor agonist from Vicore’s new molecule program (VP03) since C21. C106 is the first ATRAG to enter the clinic since C21 and its clinical debut triggered a part-cash, part-shares milestone payment to its collaborators Emeriti Bio and HaLaCore Pharma. Using methods Vicore has developed in-house, we know that C106 is highly specific with high AT2 receptor affinity and that it has anti-fibrotic activity at clinically relevant concentrations in human fibrotic lung and kidney tissue.

C106 and the other next generation ATRAGs approaching the clinic will become an increasingly important part of Vicore’s asset base over time. Each of them is an orally-available small molecule drug candidate with high affinity for the AT2 receptor with projected long-lasting intellectual property protection. C106, for instance, is expected to have patent protection until at least 2041.

The emergence of the next generation of ATRAGs is an important signal of the transformation that we are currently implementing at Vicore. The early clinical data of C21 not only open an avenue for pioneering ATRAGs in severe lung diseases such as IPF, they also act as a pathfinder for the ATRAGs, an entirely new class of drugs around which Vicore has accumulated highly valuable clinical experience, is pursuing significant intellectual property protection, all supported by a broad-ranging matrix of supporting technology. As a group, the ATRAGs have therapeutic potential well beyond rare disease. Vicore has shown that ATRAGs have the capacity to address tissue damage and reverse some functional losses in lung and kidney tissue. We anticipate that the maturation of the clinical studies of the company’s proprieatry molecules will define the scope and reach of Vicore’s ATRAG platform.

In short, during the second quarter, Vicore has continued to gain momentum as the company marches towards 2023. I want to express profound personal gratitude to the key opinion leaders who help guide the design and execution of our clinical trial programs. Similarly, we will continue to work closely with healthcare providers and funders throughout Europe and the United States as our exciting drug candidates attract attention on their way to the market. We will forge new relationships with clinical investigators and patients who honor us by joining our expanding clinical trials program. As we enter the second half of 2022 with the company growing in ambition and confidence, I remain thankful for the continued trust of investors who have shared our vision, and for the commitment and insight of the many colleagues at Vicore who day by day work to make that vision a reality.

Carl-Johan Dalsgaard

Interim report April-June, 2022; https://vicorepharma.com/investors/financial-reports/

For further information, please contact:

Carl-Johan Dalsgaard, CEO, tel: +46 70 975 98 63, carl-johan.dalsgaard@vicorepharma.com  

Hans Jeppsson, CFO, tel: +46 70 553 14 65, hans.jeppsson@vicorepharma.com

This is information that Vicore Pharma Holding AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 08:00 CET on August 25, 2022.

About Vicore Pharma Holding AB (publ)

Vicore is a clinical-stage pharmaceutical company focused on developing innovative medicines in severe diseases where the Angiotensin II type 2 receptor (AT2R) plays an important role. The company currently has four development programs, VP01, VP02, VP03 and VP04. VP01 aims to develop the substance C21 for the treatment of idiopathic pulmonary fibrosis (IPF), pulmonary artery hypertension (PAH) and COVID-19. VP02 is a new formulation and delivery route of thalidomide and focuses on the underlying disease and the severe cough associated with IPF. VP03 includes the development of new AT2 receptor agonists. VP04 develops a clinically validated digital therapeutic for IPF patients.

The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.