Year-end report 2021

Fri, Feb 25, 2022 08:00 CET

Gothenburg, February 25, 2022 - Vicore Pharma Holding AB (publ) publishes the year-end report for 2021.

Important events during the fourth quarter

In October, Vicore announced that the results from the phase 2 trial in COVID-19 (ATTRACT) were published in EClinicalMedicine, a scientific journal published by the Lancet.
In November, Vicore announced results from the ATTRACT phase 2 extension trial showing that C21 reduced long-term lung injury after COVID-19.

Important events after the period

In February, an interim analysis of the AIR phase 2 trial in idiopathic pulmonary fibrosis (IPF) suggests 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 entitity from the VP03 program to a first in human phase 1 trial. A clinical trial application (CTA) is expected to be submitted during the second quarter 2022.

Financial overview for the period
October 1 – December 31, 2021

Net sales amounted to 0.0 MSEK (0.0)
The operating loss was -81.1 MSEK (-58.8)
Loss for the period amounted to -80.4 MSEK (-58.3)
Loss per share, before and after dilution, was -1.12 SEK (-0.96)
On December 31, 2021, cash, cash equivalents and short-term investments amounted to 371.5 MSEK (318.7 MSEK as of December 31, 2020)

January 1 – December 31, 2021

Net sales amounted to 0.0 MSEK (0.0)
The operating loss was -294.8 MSEK (-149.5)
Loss for the period amounted to -296.5 MSEK (-146.9)
Loss per share, before and after dilution, was -4.25 SEK (-2.71)
The Board of Directors proposes to the Annual General Meeting that no dividend be paid for the financial year 2021

Financial summary of the group

Amounts in MSEK	2021 Oct-Dec	2020 Oct-Dec	2021 Jan-Dec	2020 Jan-Dec
Net sales	0,0	0.0	0,0	0.0
Operating loss	-81.1	-58.8	-294.8	-149.5
Loss for the period	-80.4	-58.3	-296.5	-146.9
Loss per share, before/after dilution (SEK)¹	-1.12	-0.96	-4.25	-2.71
Research and development costs/ operating costs (%)²	91.0	84.4	91.9	84.7
Equity at the end of the period	383.3	354.5	383.3	354.5
Cash flow from operating activities	-75.3	-39.1	-265.2	-119.9
Cash and cash equivalents and short-term investments at the end of the period	371.5	318.7	371.5	318.7

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 23 in the year-end report

CEO Comments

"The interim data from the IPF trial is really exciting and strengthens our confident view on the therapeutic potential of C21 in IPF. We now aim to initiate the next step in development; a randomized controlled trial, as soon as possible. If these results hold up, it will be a gamechanger in the treatment of IPF"

Vicore continued to make progress during the fourth quarter of 2021, building towards important data generation points in our ongoing clinical trials with C21 in idiopathic pulmonary fibrosis (IPF) and COVID-19, preparing for the pivotal trial with our digital therapeutic product in IPF and laying the essential groundwork for new clinical programs with proprietary candidate molecules that modulate the angiotensin II type 2 receptor (AT2R).

In February, after the reporting period, it was decided to do an interim analysis in the AIR trial, Vicore’s ongoing phase 2 clinical trial of C21 in IPF. The analysis resulted in encouraging data showing a positive FVC* change of +251 ml over baseline after 24 weeks, compared to an expected decline of 120 ml in an estimated placebo population with IPF¹, implying an +371ml difference. Furthermore, out of the seven patients who completed 36 weeks of C21 treatment, five showed continued improvement after 24 weeks and two remained stable. That C21 may stabilize disease and increases lung function is a major milestone in IPF, where, by way of reference, the currently approved treatments show a decrease of approximately 60 ml in FVC in 24 weeks¹. With these interim results in hand, we have decided to initiate the planning of AIR 2, a randomized controlled study to confirm the results and accelerate the development of C21 towards the market.

In addition, using receptor autoradiography to evaluate binding of C21 to AT2R in human lung tissue, it was demonstrated that AT2R is abundant in the (healthy) lung and that C21 significantly and specifically binds to the AT2R in the lung. This confirms that abundant AT2R in human lung enables multiple points of attack for C21. You can see the convincing images on page 8 in the year-end report.

“The results from the interim analysis and the receptor autoradiography data further strengthens the AT2R biology where Vicore is first-in-class with C21 and the follow-on molecules in the VP03 program”.

The development in the VP03 program is gathering momentum and the first drug candidate, C106, is now ready for a first in human phase 1 trial. As mentioned in our previous quarterly report, through extensive preclinical and clinical programs on C21, Vicore has uniquely accumulated a great deal of experience in modulating the C21 target receptor, AT2R, a biological system that plays a core part in the control of cellular regeneration and repair. Those processes are central in defining the symptoms and causative mechanism in a broad range of important diseases apart from IPF, such as heart failure and kidney fibrosis. Throughout 2021, our efforts to develop proprietary molecules that modulate AT2R in a controlled manner have intensified. We have established broad intellectual property protection around the class of AT2R stimulating drugs through patent filings. The development in this important pipeline program will be one of Vicore’s key priorities during 2022.

More than 50 centers in 10 countries are now active and accruing patients in ATTRACT-3, Vicore’s phase 3 pivotal trial in COVID-19. Even though the recruitment rate has grown steadily, the unpredictable COVID-19 situation has caused a delay in recruitment. We estimate that the read-out of the results from the trial will move into the second half of 2022 as opposed to the first half of 2022 as previously communicated.

The company is also in advanced stages of preparation for the clinical investigation of Vicore’s digital therapeutic for IPF. This software-based medical intervention will provide cognitive behavioral therapy that, on top of standard of care, is intended to help patients with the psychological aspects of their disease. There are two phases to the investigation; the pilot study is intended to examine some of the principal assumptions around the design and operation of the digital therapeutic with approximately 20 IPF patients. The essential data gathered in the pilot study will lead to the subsequent pivotal study needed for the approval of the product. This pivotal phase is estimated to start during the third quarter of 2022 and will involve approximately 250 patients as well as physicians, and subsequently payers concerned with advanced IPF care.

In the VP02 program, we are investigating different formulations for delivering thalidomide - recognized as an effective therapeutic tool for IPF cough – to the lungs to treat the cough without exposing the patient for levels that give rise to systemic side effects. This chemistry and preclinical work is continuing during the first half of 2022 but is going slower than expected and we estimate a delay in starting a clinical trial.

During the past year we have generated important clinical data on our lead compound, C21 and, at the same time, we are on the verge of opening fresh clinical opportunities with the next generation of AT2R agonists. Vicore is poised to move forward on several fronts in 2022 and as we enter a new calendar year, I would like once again to extend my gratitude to our employees for their hard work and dedication under the trying circumstances of the past several quarters, to the patients who are involved in our clinical trials, to our growing global network of clinical collaborators and to our shareholders for their continued support of Vicore’s work.

Carl-Johan Dalsgaard
CEO

* Forced Vital Capacity, a measure of lung function
1. Richeldi et al 2014; King et al 2014

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

Year-end report 2021: https://vicorepharma.com/investors/financial-reports/

This information was submitted for publication on February 25, 2022, at 08:00 CET.

About Vicore Pharma Holding AB (publ)
Vicore is a clinical-stage pharmaceutical company focused on developing innovative medicines in severe lung 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) 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.