Interim report January – March 2022
Important events during the first quarter
- In February, an interim analysis of the AIR phase 2 trial in idiopathic pulmonary fibrosis (IPF) suggested that C21 stabilizes disease and shows an unanticipated increase in lung function in IPF patients.
- In February, Vicore announced the advancement of its first new chemical entity (C106) from the VP03 program to a first in human phase 1 trial.
- In March, Vicore announced the plan to initiate a proof-of-concept trial with C21 in pulmonary arterial hypertension (PAH).
- In March, Vicore announced the initiation of a human forearm blood flow study with C21, planned to start in Q2 2022.
- In March, Vicore announced that Michael Wolff Jensen resigned from the board and was replaced by Jacob Gunterberg as chairman until the Annual General Meeting in May 2022.
Important events after the period
- 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 study with the new drug candidate (C106) from the VP03 program.
Financial overview for the period
January 1 – March 31, 2022
- Net sales amounted to 0.0 MSEK (0.0)
- The operating loss was -93.2 MSEK (-47.5)
- Loss for the period amounted to -93.4 MSEK (-48.1)
- Loss per share, before and after dilution, was -1.30 SEK (-0.76)
- On March 31, 2022, cash, cash equivalents and short-term investments amounted to 300.6 MSEK (371.5 MSEK as of December 31, 2021)
Financial summary of the group
|Amounts in MSEK||2022
|Loss for the period||-93.4||-48.1||-296.5|
|Loss per share, before/after dilution (SEK)1||-1.30||-0.76||-4.25|
|Research and development costs/
operating costs (%)2
|Equity at the end of the period||291.2||629.1||383.3|
|Cash flow from operating activities||-71.6||-47.7||-265.2|
|Cash and cash equivalents and short-term
investments at the end of the period
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 21 in the interim report.
The robust safety profile of our lead compound is important both for the future of C21 itself in the treatment of COVID-19 and IPF and for the message it sends about the prospects of other ATRAG drug candidates Vicore has in development.
A lot has happened in the first quarter of 2022 for Vicore as the company starts to see the fruit of strategies it has pursued for a considerable time. On the clinical front, we began Q1 with positive results from an interim analysis in the phase 2 trial with C21 in IPF and followed that by announcing plans to start a proof of concept trial with C21 in another rare lung disease, pulmonary arterial hypertension (PAH). The company has also advanced the first of its novel proprietary angiotensin II type 2 receptor agonists (ATRAGs), now ready to enter clinical trials. Meanwhile, both the ongoing trials with C21 – in IPF and in COVID-19 – have been cleared to continue uninterrupted by their respective independent Data Monitoring Committees, adding to the growing safety profile of C21. The robust safety profile of our lead compound is important both for the future of C21 itself in the treatment of COVID-19 and IPF and for the message it sends about the prospects of other ATRAG drug candidates Vicore has in development. Throughout the rest of the year, we will continue to work closely with patient groups and clinicians to advance both C21 and our digital therapeutic product in IPF.
The company held a virtual R&D day on March 10 to update investors and potential collaborators on the progress made during the past year and to share some of our near-term future plans.
During the R&D day, we were able to present the details of the highly encouraging data that came from the interim analysis of the AIR trial with C21 in IPF. As reported in February 2022, the interim data gave a clear indication of the potential of C21 to restore lung function. Without treatment, the course of IPF is sadly predictable: patients inexorably lose lung function, with Forced Vital Capacity (FVC) – a standard measure of functional lung volume – declining around 120 ml each 24 weeks. However, when patients received C21, we didn’t observe a decline in FVC. Instead, in the first nine patients given C21 for 24 weeks, FVC on average increased by +250 ml. A further 12 weeks of C21 treatment led to additional positive improvements in FVC in five out of seven patients, while two remained stable.
The AIR trial continues and Vicore expects to provide further updates on its progress during the course of 2022. Meanwhile, in the light of the early positive results, the company plans to increase its efforts in IPF and related areas. Vicore is already working in close collaboration with leading clinicians, regulatory authorities and patient organizations to design the next trial with C21 in IPF in order to execute on our obligation to accelerate the development of our lead molecule. We announced in March that we are also planning to begin a clinical trial with C21 in PAH, a rare lung disease that shares vasculopathy with IPF.
In parallel, we are preparing to expand the number of ATRAG molecules that we have in development. A number of agonist molecules are emerging from the preclinical development programs and we have submitted an application to the regulatory authorities to begin a Phase 1 safety study on one of them, C106.
In March, Vicore initiated a new clinical program to allow the company to efficiently build out the ATRAG program once the initial safety profiles of the newly emerging molecules have been established. The program assesses the effects in humans at increasing doses of C21 on vasodilation and forearm blood flow. This relatively simple method generates a baseline in human subjects of the dose-effect relationship for C21 that can be used to effectively assess the correct dose of new ATRAGs as they too progress in the clinic.
I am pleased to be able to report that the pilot phase of the clinical investigation of Vicore’s digital cognitive behavioral therapy involving 20 patients has begun. A larger pivotal phase of the investigation – involving around 250 patients – is expected to follow in the second half of the year. The digital therapy now has a name that reflects the personal nature of the product – AlmeeTM. The clinical investigation (COMPANION) will take place in the United States and is expected to run until H1 2023. Using decentralized and virtual clinical research solutions, the trial will evaluate the impact of AlmeeTM on the psychological symptom burden in adults with IPF. In keeping with Vicore’s mission to involve IPF stakeholders deeply in the development of our therapies, the company has organised a meeting at the American Thoracic Society meeting being held in San Francisco in May this year to introduce the concepts and details of the trial to an invited audience of pulmonary clinicians. The results of the COMPANION trial will contribute to the package of information which will be submitted to the US Food and Drug Administration (FDA). Our recent constructive meeting with the FDA in March provided reassurance that Vicore and the regulatory authority continue to remain aligned on the design of the clinical trial for AlmeeTM.
For Vicore, 2022 has started at an amazing pace and the momentum is likely to continue throughout the rest of the year and into 2023. The company will continue to extend its network of relations with key clinical opinion leaders, payers and healthcare providers throughout Europe and the United States. As the company progresses, we remain grateful to clinical investigators and patients who are part of our ongoing clinical trials. I would like to express my personal thanks for the trust and continued support of our investors, for the dedication of the agile and industrious Vicore colleagues and last but not least, the patients and clinicians contributing to our trials.
Carl-Johan Dalsgaard, CEO
Interim report January-March, 2022; https://vicorepharma.com/investors/financial-reports/
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This information was submitted for publication on May 5, 2022 at 08:00 CET.