Interim report July-September 2022

Thu, Nov 03, 2022 08:00 CET

Stockholm, November 3, 2022 - Vicore Pharma Holding AB (publ) publishes the interim report for the third quarter 2022.

Important events during the third quarter

In August, Vicore announced late-breaker presentation of interim data with C21 in the IPF trial (AIR) at the 2022 ERS congress.
In September, Vicore announced continued stabilization and increase in lung capacity with C21 in the IPF trial (AIR) and a second interim analysis planned for Q4 2022.
In September, Vicore announced that the phase 3 trial with C21 in COVID-19 (ATTRACT-3) did not reach the primary and secondary endpoints. Further clinical development in this indication will be discontinued.
In September, Vicore announced that clinically relevant doses of C21 increase bloodflow in humans without affecting systemic blood pressure and with no side effects observed.

Important events after the period

In October, Vicore announced that a pilot study with the company's digital therapeutic in IPF (COMPANION) showed nearly 50% reduction in anxiety according to the GAD-7 scale.
In October, Vicore announced that C103, a new angiotensin II type 2-receptor agonist (ATRAG), was selected as next drug candidate.

Financial overview for the period

July 1 – September 30, 2022

Net sales amounted to 0.0 MSEK (0.0)
The operating loss was -69.7 MSEK (-97.8)
Loss for the period amounted to -68.5 MSEK (-97.6)
Loss per share, before and after dilution, was -0.95 SEK (-1.36)
On September 30, 2022, cash, cash equivalents and short-term investments amounted to 169.8 MSEK (371.5 MSEK as of December 31, 2021)

January 1 - September 30, 2022

Net sales amounted to 0.0 MSEK (0.0)
The operating loss was -227.7 MSEK (-213.7)
Loss for the period amounted to -227.7 MSEK (-216.0)
Loss per share, before and after dilution, was -3.17 SEK (-3.13)

Financial summary of the group

Amounts in MSEK	2022 Jul-Sep	2021 Jul-Sep	2022 Jan-Sep	2021 Jan-Sep	2021 Jan-Dec
Net sales	0.0	0.0	0.0	0.0	0,0
Operating loss	-69.7	-97.8	-227.7	-213.7	-294.8
Loss for the period	-68.5	-97.6	-227.7	-216.0	-296.5
Loss per share, before/after dilution (SEK)¹	-0.95	-1.36	-3.17	-3.13	-4.25
Research and development costs/ operating costs (%)²	85.5	93.5	85.3	92.2	91.9
Equity at the end of the period	160.7	462.6	160.7	462.6	383.3
Cash flow from operating activities	-66.7	-68.4	-199.7	-189.9	-265.2
Cash and cash equivalents and short-term investments at the end of the period	169.8	446.9	169.8	446.9	371.5

¹There 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.

CEO Comments

Vicore is developing C21 for rare lung diseases and has a series of new ATRAGs (angiotensin II type 2 receptor agonists) in development for other indications. The first of these, C106, is now in a phase I trial and the second, C103, has been selected for toxicology studies.

In the third quarter of 2022, Vicore’s progress continued. Our clinical experience and knowledge, generated through studies of C21 in a range of conditions including severe lung diseases, now forms the basis for the development of an entirely new class of drugs, angiotensin II type 2 receptor (AT2R) agonists (ATRAGs).

The AT2R is part of the body’s resolution and repair system, protective in several diseases connected to ageing and cell senescence, including idiopathic pulmonary fibrosis (IPF), chronic kidney disease, heart failure and cognitive disorders. Vicore is developing C21 for rare lung diseases and has a series of new ATRAGs in development for other indications. The first of these, C106, is now in a phase 1 trial and the second, C103, has been selected for toxicology studies.

In IPF, the phase 2 trial with C21 (AIR) is progressing following the promising interim findings we announced in February, showing that lung function increased by a clinically meaningful degree in a high proportion of C21-treated patients. We expect to report a second interim analysis during Q4 and are in discussions with advisers and clinical experts on the design for the next trial after which we expect to provide an update on the development program. We also plan to initiate a phase 2a clinical trial with C21 in pulmonary arterial hypertension (PAH), a rare lung disease with significant unmet medical need, in H1 2023. This is based on the strong interim data in IPF as well as preclinical data showing that C21 reverses vascular remodelling and significantly improves hemodynamics.

In September, we reported on a clinical method for rapid assessment of the ATRAGs. Using C21 administered intra-arterially into the forearm at clinically-relevant levels, we were able to show significant dose-dependent increases in local blood flow. The results indicate that the forearm blood flow technique can provide a simple and robust method in humans for exploring clinically relevant doses of C21 and other ATRAGs. This methodology is likely to be important in accelerating transitions from preclinical to clinical investigations across the entire Vicore portfolio.

C21 remains a key component of Vicore’s ongoing clinical programs in IPF and PAH. Following the discontinuation of the ATTRACT-3 phase 3 trial announced in September, Vicore is no longer pursuing opportunities for C21 in COVID-19. The phase 2 ATTRACT trial earlier showed the ability of C21 to reduce alveolar damage in severe COVID-19 infection in the lower respiratory tract, a type of lung injury that waned as new variants of the virus including Omicron evolved later in the pandemic. ATTRACT-3 nevertheless contributed a great deal to Vicore's ongoing programs. It provided an extensive resource of additional safety data underpinning the company’s broader mission as well as clear insights into the role of C21 and other ATRAGs in stimulating alveolar epithelial cells.

A clinical platform company

The next ATRAG from Vicore’s pipeline, C106, is now in a double-blind, placebo-controlled, randomized, single-center phase 1 trial to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses in healthy volunteers. Readout from the trial is expected in H1 2023.

C106 is the first of four advanced drug candidates from our ATRAG program with the potential to underpin our transformation into a clinical platform company with a new class of drugs. All four are small molecules with high affinity for the AT2R and are intended for indications beyond rare lung disease. Vicore has shown that ATRAGs have the capacity to address tissue damage and reverse functional losses in lung and kidney tissue.

The ATRAG pipeline has been strengthened with the selection of C103 as the next candidate to move into toxicology studies. Preclinical studies on C103 demonstrate high affinities for the AT2R over the AT1R, a profile that supports a role in preeclampsia, an indication with limited treatment options today.

Positive early Almee^TM data

As part of Vicore’s integrated approach in the care of patients with severe lung disease, the company recently reported positive results with the digital therapy (DTx) for patients with pulmonary fibrosis, AlmeeTM. This came from the pilot phase of the COMPANION study. The pilot phase of COMPANION showed that the DTx was safe, functional, and user-friendly. Importantly, even in the small number of IPF patients involved in the pilot phase, it reduced anxiety symptoms by 49%, a positive indicator that it has the potential to address the psychological impact of living with IPF. The pivotal phase of COMPANION will start in Q4 2022, with topline read-outs scheduled for H2 2023.

Vicore continued to maintain a high profile at scientific congresses, presenting data at several prestigious conferences throughout the third quarter. These included the European Respiratory Society (ERS) Congress, the European Society of Cardiology (ESC) Congress, the 6th IPF Summit and the 21st International Colloquium on Lung and Airway Fibrosis (ICLAF 2022).

Overall, Vicore has maintained positive momentum through the third quarter. This is an ideal moment to extend my gratitude to all involved in Vicore for their support in making our ambition, to unlock the potential of ATRAGs - a new class of drugs, possible.

Carl-Johan Dalsgaard

Interim report July-September, 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 information was submitted for publication on November 3, 2022 at 08:00 CET.

About Vicore Pharma Holding AB (publ)

Vicore is an innovative Swedish clinical-stage pharmaceutical company dedicated to creating life-changing treatments in diseases where the Angiotensin II type 2 receptor (AT2R) has a central protective 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 pulmonary artery hypertension (PAH). VP02 is a new formulation and delivery route of thalidomide and focuses on the underlying disease and the severe cough associated with IPF. In the VP03 program new AT2 receptor agonists are developed. VP04 is a clinically validated digital therapeutic in development for IPF patients.

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