Interim report April - June 2021

Gothenburg, August 26, 2021 - Vicore Pharma Holding AB (publ) publishes the interim report for the second quarter 2021.

Important events during the second quarter

  • In May, Vicore1 announced that it had entered into a collaboration agreement with Alex Therapeutics for the development of a digital therapeutic (DTx) for patients living with idiopathic pulmonary fibrosis (IPF).
  • In June, Vicore announced that it had received approval from the U.S. Food and Drug Administration (FDA) to start the pivotal phase 3 trial with C21 in COVID-19.

Important events after the period

  • No important events have occured after the period.

Financial overview for the periodApril 1 - June 30, 2021

  • Net sales amounted to 0.0 MSEK (0.0)
  • The operating loss was -68.4 MSEK (-27.5)
  • Loss for the period amounted to -70.4 MSEK (-24.2)
  • Loss per share, before and after dilution, was -0.98 SEK (-0.48)
  • On June 30, 2021, cash and cash equivalents and short-term investments amounted to 514.4 MSEK (318.7 MSEK as of December 31, 2020)

January 1 - June 30, 2021

  • Net sales amounted to 0.0 MSEK (0.0)
  • The operating loss was -116.0 MSEK (-56.3)
  • Loss for the period amounted to -118.5 MSEK (-52.6)
  • Loss per share, before and after dilution, was -1.75 SEK (-1.04)

Financial summary of the group

Amounts in MSEK 2021
Apr-Jun
2020
Apr-Jun
2021
Jan-Jun
2020
Jan-Jun
2020
Jan-Dec
Net sales 0.0 0.0 0.0 0.0 0.0
Operating loss -68.4 -27.5 -116.0 -56.3 -149.5
Loss for the period -70.4 -24.2 -118.5 -52.6 -146.9
Loss per share, before/after dilution (SEK)1 -0.98 -0.48 -1.75 -1.04 -2.71
Research  and development costs/
operating costs (%)2
92.7 85.4 91.1 84.6 84.7
Equity at the end of the period 559.2 272.7 559.2 272.7 354.5
Cash flow from operating activities -73.8 -25.8 -121.5 -55.1 -119.9
Cash and cash equivalents and short-term
investments at the end of the period
514.4 212.4 514.4 212.4 318.7

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

Vicore made several advancements during the second quarter of 2021 with its clinical development programs in both IPF and COVID-19.

In June, Vicore became a phase 3 stage company, as the U.S. Food and Drug Administration (FDA) approved the start of our ATTRACT-3 clinical trial in the United States. ATTRACT-3 is a global, 600 patient, placebo-controlled phase 3 study looking at the effectiveness of C21 to restore lung function in patients who are hospitalized as a result of a COVID-19 infection. Following our successful phase 2 trial conducted during the initial waves of COVID-19, ATTRACT-3 is a pivotal trial which aims to generate key data to enable regulatory bodies, including the FDA, to assess the use of C21 in treating COVID-19 patients.

The green light from the FDA allows hospitals in Vicore's US clinical network to begin recruiting patients. In parallel, Vicore continues the process of activating clinical trial sites in South and Central America, Europe, Africa and Asia. ATTRACT-3 has the go-ahead from regulators in Brazil, Czechia, India, Ukraine and South Africa and study site initiation is ongoing in these countries. 

Vicore's management team and clinical advisors maintain a continuous and open communication with both the science and investment communities. As the COVID-19 pandemic enters its next phase, we continue to emphasize two particularly important aspects of ATTRACT-3: that the study will include patients infected with different variants of COVID-19; and that therapies to improve respiratory outcomes and promote patient recovery directly - as C21 does - will be vital since we will not reach full vaccination in the near term and new, potentially more vaccine resistant, mutations are developing.

Vicore has a 360-degree strategy for addressing serious rare lung diseases. In May, in a collaborative program with Alex Therapeutics, we launched the development of VP04, a proprietary prescription digital therapeutic for patients with idiopathic pulmonary fibrosis (IPF). VP04 will be one element in a suite of treatments for IPF, sitting alongside our development programs for drug therapies such as VP01(C21) and our inhaled thalidomide product for IPF and IPF cough, VP02.

VP04 is designed to support patients in dealing with the psychological burden of IPF and improve quality of life. It is being developed to be prescribed to relevant patients and therefore will need regulatory approval based on clinical evidence of effectiveness. It will also help increase awareness and understanding of IPF amongst healthcare professionals including physicians and payers.

Vicore's other clinical programs in IPF remain on schedule. Results from the phase 2 AIR study of C21 in IPF are expected at the end of 2022 at current recruiting plan and outlook as patient recruitment continues in India, Ukraine, the United Kingdom and Russia. The VP02 program is ready to initiate GLP toxicity studies during the fall of 2021  followed by a phase 1 study in 2022. We remain on course to submit a clinical trial application (CTA) for VP03 by the end of 2021.

The Vicore team is expanding, our possibilities are growing, and our operations are becoming global. As ever, I would like to thank the participants in our clinical trials,  our increasing circle of clinical collaborators around the world, our shareholders for their continuous support of Vicore's work and our employees for responding smoothly to the challenges of growth.

Carl-Johan Dalsgaard

For further information, please contact:

Carl-Johan Dalsgaard, CEO, tel: +46 70 975 98 63, [email protected]  

Hans Jeppsson, CFO, tel: +46 70 553 14 65, [email protected]

This information was submitted for publication on August 26, 2021 at 08:00 CET.

1.  The group ("Vicore") consists of the parent company, Vicore Pharma Holding AB (publ)  and the subsidiaries Vicore Pharma AB and INIM Pharma AB.

About Vicore Pharma Holding AB (publ)

Vicore 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

Delårsrapport juli - september 2021

Göteborg, 4 november 2021 - Vicore Pharma Holding AB (publ) publicerar sin delårsrapport för tredje kvartalet 2021.


Interim report July - September 2021

Gothenburg, November 4, 2021 - Vicore Pharma Holding AB (publ) publishes the interim report for the third quarter 2021.


Vicores C21 minskar långsiktiga lungskador efter COVID-19 i ATTRACT fas 2 uppföljningsstudien

  • Resultaten visade närmare 50% minskning av uppkomna lungskador efter behandling med C21  jämfört med placebo
  • Dessa positiva fynd tillsammans med tidigare kliniska resultat1 talar för att C21 kan påskynda återhämtningen  
  • C21 utvärderas för närvarande vid en fas 3-studie i COVID-19 patienter

Göteborg,  2 november, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), ett särläkemedelsföretag som utvecklar innovativa behandlingar mot svåra lungsjukdomar, meddelar idag resultat att behandling med bolagets AT2R agonist, C21, minskar långsiktiga lungskador hos sjukhusinlagda COVID-19 patienter.


Lancets EClinicalMedicine publicerar resultat från fas 2-studie med C21 i COVID-19

  • Studien visade att C21 minskade behovet av syrgas- och respiratorbehandling, vilket indikerar en snabbare återhämtning. C21 var också säkert och väl tolererat.
  • Resultaten låg till grund för Vicores beslut att gå vidare med en fas 3-studie vilken beräknas vara klar första halvåret 2022.

Göteborg, 25 oktober, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), ett särläkemedelsföretag som utvecklar innovativa behandlingar mot svåra lungsjukdomar, meddelar idag att resultaten från fas 2-studien ATTRACT med angiotensin II typ 2 receptor agonisten C21 i COVID-19 har publicerats i EClinicalMedicine, en expertgranskad vetenskaplig tidskrift utgiven av The Lancet. Publikationen finns tillgänglig online via denna länk.


Lancet's EClinicalMedicine publishes phase 2 data on C21 in COVID-19

  • The trial showed that C21 reduced the need for supplemental oxygen and mechanical ventilation, indicating faster patient recovery. C21 was also found to be safe and well tolerated.
  • Data encouraged Vicore to move into phase 3 with readout on-track for H1 2022.

Gothenburg, October 25, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), a rare disease pharmaceutical company developing innovative medicines for severe lung disorders, today announces that the results of the COVID-19 phase 2 trial of its angiotensin II type 2 receptor agonist C21 have been published in EClinicalMedicine, a peer reviewed clinical journal, published by The Lancet. The paper is available online via this link.


Vicore offentliggör valberedningen inför årsstämman 2022

Göteborg, 20 oktober, 2021 - Vicore Pharma Holding AB (publ) har utsett valberedningen inför årsstämman 2022. De tre största aktieägarna per den 31 augusti 2021 har erbjudits att utse en ledamot till valberedningen vardera, i enlighet med beslutet som togs på årsstämman den 11 maj 2021.


Vicore håller webbinarium om C21 för behandling av idiopatisk lungfibros (IPF)

Webbinariet hålls torsdagen den 30 september @16:00 CET (10:00 am EST) med läkarna och IPF-experterna, Prof. Toby Maher och Prof. Joanna Porter.

Göteborg, 22 september, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), ett särläkemedelsbolag som utvecklar innovativa läkemedel mot svåra lungsjukdomar meddelar idag att bolaget kommer att hålla ett webbinarium om C21, Vicores ledande läkemedelsmolekyl, för behandling av idiopatisk lungfibros (IPF), torsdagen den 30 september kl. 16:00 CET (10:00 am EST).


Vicore to host Key Opinion Leader webinar on C21 for the treatment of idiopathic pulmonary fibrosis (IPF)

Webinar on Thursday, September 30 @ 16:00 CET (10AM ET) with the medical doctors and IPF experts Prof. Toby Maher and Prof. Joanna Porter.

Gothenburg, September 22, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), a rare disease pharmaceutical company developing innovative medicines for severe lung disorders such as idiopathic pulmonary fibrosis (IPF), today announced it will host a key opinion leader (KOL) webinar on C21, the company's lead asset for the treatment of idiopathic pulmonary fibrosis (IPF) on Thursday, September 30, 2021 at 16:00 CET (10 AM Eastern Time).


Vicore erhåller SARS coronavirus-patent för C21 i USA

Göteborg, 22 september, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), ett särläkemedelsföretag som utvecklar innovativa behandlingar mot svåra lungsjukdomar, meddelar idag att US Patent and Trademark Office (USPTO) har beviljat patentet US11,123,329 som omfattar användningen av C21 för att behandla infektioner orsakade av Severe Acute Respiratory Syndrome (SARS) coronavirus (CoV), inklusive SARS-CoV-2.


Vicore behandlar första COVID-19 patienterna i den globala fas 3-studien ATTRACT-3

Göteborg, 17 september, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), ett särläkemedelsbolag som utvecklar innovativa läkemedel mot svåra lungsjukdomar meddelar idag att de första patienterna i bolagets globala fas 3-studie med C21 i COVID-19 (ATTRACT-3) doserats.

  • Tidigare rapporterade positiva resultat från fas 2-studien ger starkt stöd för fortsatt utvärdering av Vicores AT2 receptor agonist C21 i COVID-19
  • Den pivotala fas 3-studien är nu godkänd i USA, Ukraina, Sydafrika, Brasilien, Tjeckien, Filippinerna och Indien med syftet att undersöka effektiviteten och säkerheten av C21 på sjukhusinlagda patienter med COVID-19

Göteborg, 17 september, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), ett särläkemedelsbolag som utvecklar innovativa läkemedel mot svåra lungsjukdomar meddelar idag att de första patienterna i bolagets globala fas 3-studie med C21 i COVID-19 (ATTRACT-3) doserats.


Vicore starts dosing of first COVID-19 patients in the global phase 3 trial ATTRACT-3

Gothenburg, September 17, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), a rare disease pharmaceutical company developing innovative medicines for severe lung disorders today announces the dosing of the first patients in the company's global phase 3 trial of C21 in COVID-19 (ATTRACT-3).

  • Previously reported positive phase 2 trial results strongly support further evaluation of the Vicore AT2 receptor agonist C21 in COVID-19
  • The pivotal phase 3 trial is currently approved in the US, Ukraine, South Africa, Brazil, Czechia, Philippines and India to investigate the efficacy and safety of C21 in hospitalized patients with COVID-19

Vicore stärker sin ledningsgrupp

Göteborg, 27 augusti, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), ett särläkemedelsbolag som utvecklar innovativa läkemedel för fibrotiska lungsjukdomar som idiopatisk lungfibros (IPF), meddelar idag att bolagets ledningsgrupp stärks med tre seniora rekryteringar när bolagets forsknings- och utvecklingsaktiviteter närmar sig viktiga kommersiella milstolpar.


Delårsrapport april - juni 2021

Göteborg, 26 augusti 2021 - Vicore Pharma Holding AB (publ) publicerar sin delårsrapport för andra kvartalet 2021.


Interim report April - June 2021

Gothenburg, August 26, 2021 - Vicore Pharma Holding AB (publ) publishes the interim report for the second quarter 2021.


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.


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