Interim report January - March 2021

Gothenburg, May 5, 2021 - Vicore Pharma Holding AB (publ) publishes the interim report for the first quarter 2021.

Important events during the first quarter

  • In February, Vicore completed a directed share issue raising 336 MSEK. The share issue was approved at an Extraordinary General Meeting in March.
  • In March, Vicore reported top-line data  from the mechanistic phase II study in systemic sclerosis and Raynaud's phenomenon (SSc) showing that C21 increased bloodflow in fibrotic tissue.

Important events after the period

  • In May, Vicore announced that it has entered into a collaboration agreement with Alex Therapeutics for the development of a digital therapeutic (DTx) for patients living with idiopathic pulmonary fibrosis (IPF).

Financial overview for the periodJanuary 1 - March 31, 2021

  • Net sales amounted to 0.0 MSEK (0.0)
  • The operating loss was -47.5 MSEK (-28.8)
  • Loss for the period amounted to -48.1 MSEK (-28.4)
  • Loss per share, before and after dilution, was -0.76 SEK (-0.56)
  • On March 31, 2021, cash and cash equivalents and short-term investments amounted to 589.9 MSEK (318.7 MSEK as of December 31, 2020)

Financial summary of the group

Amounts in MSEK 2021
Jan-Mar
2020
Jan-Mar
2020
Jan-Dec
Net sales 0.0 0.0 0.0
Operating loss -47.5 -28.8 -149.5
Loss for the period -48.1 -28.4 -146.9
Loss per share, before/after dilution (SEK)1 -0.76 -0.56 -2.71
Research and development costs/
operating costs (%)2
88.7 83.6 84.7
Equity at the end of the period 629.1 296.3 354.5
Cash flow from operating activities -47.7 -29.3 -119.9
Cash and cash equivalents and short-term
investments at the end of the period
589.9 238.0 318.7

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 first quarter of 2021 has been very productive for Vicore continuing to build on the clinical success achieved with C21 in 2020.

In the beginning of February, the company raised 336 MSEK (approx. 40 MUSD) in a directed share issue that attracted Swedish and international institutional investors, including existing shareholders. The strengthened financial position allows Vicore to fund operations well into 2023.

The fundraising followed results of Vicore's phase II COVID-19 trial ATTRACT. The data, published on the online preprint server medRxiv at the beginning of January, showed that C21, Vicore's angiotensin type 2 receptor agonist, spares the need for oxygen supplementation and clearly restores respiratory function in hospitalized COVID-19 patients. Following the successful phase II trial, Vicore's plans for a multinational, placebo-controlled phase III trial of C21 for COVID-19 are well advanced. The phase III trial is scheduled to start in the summer of 2021 once we receive FDA approval to initiate the study.

Vicore's clinical program in idiopathic pulmonary fibrosis (IPF) remains on track. Recruitment for the phase II international AIR study with C21 is on schedule in India, Ukraine, UK and Russia after the first patient was recruited in November 2020. Readout from the AIR study is anticipated for the end of 2022.

Vicore also expects to submit a Clinical Trial Application by the end of 2021 for VP02, Vicore's inhaled formulation of thalidomide for treating IPF and IPF cough.

In March, Vicore also published top line data from our phase II study in systemic sclerosis and Raynaud's phenomenon (SSc) showing that C21 can increase blood flow in fibrotic tissue, a result that further differentiates C21 from its competitors in pulmonary fibrosis, and we anticipate will demonstrate cross-over benefits for patients with IPF.

As part of our continuing commitment to the global community of IPF patients, we have initiated, in collaboration with Alex Therapeutics, an evidence-based digital therapeutic provider, the development of a digital therapeutic (DTx) that will be proprietary to Vicore. The product will be designed to provide cognitive behavioral therapy that IPF patients can use to address the psychological aspect of their disease and to improve patient outcome. The addition of this program, VP04, allows Vicore to offer a comprehensive care package which also includes the highly promising VP01 and VP02 programs targeting the underlying causes and major symptoms of IPF.

The Vicore team continues to respond to challenging and somewhat unforeseen events during the pandemic with great commitment. I would like to thank all our employees for their contributions, and our shareholders for continuing to support our work as we seek to take a whole-patient approach to alleviate the pain and suffering caused by fibrotic lung disease.

Carl-Johan Dalsgaard, CEO

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 May 5, 2021 at 08:00 CET.

About Vicore Pharma Holding AB (publ)
Vicore Pharma is a rare disease pharmaceutical company focused on fibrotic lung disease and related indications. 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 based on 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 AT2R 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

Vicore meddelar om deltagande i investerarmöten under juni 2021

Göteborg, 15 juni, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), som ett särläkemedelsbolag som utvecklar innovativa läkemedel mot fibrotiska lungsjukdomar som idiopatisk lungfibros (IPF), meddelar idag om deltagande i två investerarkonferenser under juni månad 2021.


Vicore har erhållit godkännande från FDA för att starta en pivotal fas 3-studie med C21 i COVID-19

Göteborg, 11 juni, 2021 - Vicore Pharma Holding AB (publ) ("Vicore") ett särläkemedelsbolag som utvecklar innovativa läkemedel mot fibrotiska lungsjukdomar som idiopatisk lungfibros (IPF), meddelar idag att amerikanska U.S. Food and Drug Administration (FDA) har godkänt dess Investigational New Drug (IND)-ansökan för bolagets läkemedelskandidat och oralt tillgängliga angiotensin II type 2 receptor (AT2R) agonist, C21, för behandling av COVID-19. En aktiv IND gör det möjligt att påbörja bolagets pivotala fas 3-studie, ATTRACT-3, i USA.


Vicore announces FDA acceptance for pivotal phase 3 trial of C21 in COVID-19

Gothenburg, June 11, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), a rare disease pharmaceutical company developing innovative medicines for fibrotic lung disorders such as idiopathic pulmonary fibrosis (IPF), today announces that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for the company's lead asset, the orally available angiotensin II type 2 receptor (AT2R) agonist C21, for the treatment of COVID-19. The active IND enables initiation of US sites in Vicore's pivotal phase 3 trial, ATTRACT-3.


Kommuniké från årsstämma i Vicore Pharma Holding AB (publ)

Vid årsstämma i Vicore Pharma Holding AB (publ) den 11 maj 2021 fattades följande beslut.


Delårsrapport januari - mars 2021

Göteborg, 5 maj 2021 - Vicore Pharma Holding AB (publ) publicerar sin delårsrapport för första kvartalet 2021.


Interim report January - March 2021

Gothenburg, May 5, 2021 - Vicore Pharma Holding AB (publ) publishes the interim report for the first quarter 2021.


Vicore inleder samarbete med Alex Therapeutics för att utveckla en digital terapi för patienter med IPF

  • Webbinarium kommer hållas idag kl. 15:00 CET (9:00 am EST)
  • Jessica Shull, expert på digitala terapier har rekryterats till Vicore för att driva DTx-programmet

Vicore Pharma håller webbinarium om C21 för behandling av COVID-19

Webbinariet hålls onsdagen den 28 april @ 14:00 CET (08:00 am EST)

Göteborg 20 april 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), ett läkemedelsbolag som
utvecklar innovativa läkemedel mot allvarliga lungsjukdomar som idiopatisk lungfibros (IPF)
meddelade idag att bolaget kommer att hålla ett webbinarium om C21, Vicore's ledande
läkemedelsmolekyl, för behandling av COVID-19, onsdagen den 28 april 2021 kl. 14:00 CET
(08:00 am EST).


Vicore Pharma offentliggör årsredovisning för 2020

Göteborg, 15 april 2021 - Vicore Pharma Holding AB (publ) , ett läkemedelsbolag som utvecklar innovativa läkemedel mot allvarliga lungsjukdomar som idiopatisk lungfibros (IPF) offentliggör idag årsredovisningen för 2020.



Ökning av antalet aktier och röster i Vicore Pharma

Göteborg, 31 mars 2021 - Vicore Pharma Holding AB (publ):s registrerade aktiekapital och antal utestående aktier och röster har ökat under mars månad 2021.  


Vicore Pharma's läkemedelskandidat C21 vidgar perifera blodkärl vid fibrotisk sjukdom

Göteborg, 11 mars 2021 - Vicore Pharma Holding AB (publ), ett läkemedelsbolag som utvecklar innovativa läkemedel mot allvarliga lungsjukdomar som idiopatisk lungfibros (IPF), presenterar idag topline-resultat från en fas II-studie med den orala angiotensin II typ 2 receptor (AT2R) agonisten C21 i patienter med systemisk skleros och Raynauds fenomen. I denna mekanistiska studie med 12 patienter som erhöll en singeldos C21 detekterade inte den fördefinierade variabeln "yta-under-temperaturkurvan" någon skillnad mot placebo, medan vid sista mätpunkten visades statistiskt signifikant effekt av C21 på återställande av hudtemperaturen som ett resultat av en kärlvidgande effekt på perifera blodkärl.


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