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Interim report July-September 2022

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

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.

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 AlmeeTM  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, 2022https://vicorepharma.com/investors/financial-reports/

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 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.

Ökning av antalet aktier och röster i Vicore Pharma

Stockholm, 30 december 2022 - Vicore Pharma Holding AB (publ) ("Vicore" eller "bolaget"):s registrerade aktiekapital och antal utestående aktier och röster har ökat under december månad 2022.


Vicore har genomfört en riktad nyemission av 10 000 000 aktier till en teckningskurs om 20 kronor per aktie och tillförs en bruttolikvid om 200 miljoner kronor

EJ FÖR OFFENTLIGGÖRANDE, PUBLICERING ELLER DISTRIBUTION HELT ELLER DELVIS, DIREKT ELLER INDIREKT, I ELLER TILL USA, AUSTRALIEN, KANADA, NYA ZEELAND, HONG KONG, JAPAN ELLER NÅGON ANNAN JURISDIKTION DÄR SÅDANT OFFENTLIGGÖRANDE, PUBLICERING ELLER DISTRIBUTION SKULLE VARA OTILLÅTEN ELLER KRÄVA REGISTRERING ELLER ANDRA ÅTGÄRDER.

Stockholm, 8 december 2022 - Vicore Pharma Holding AB (publ) ("Vicore" eller "Bolaget"), ledande inom utveckling av angiotensin II typ 2-receptor agonister (ATRAGs), har genomfört en riktad nyemission av 10 000 000 aktier till en teckningskurs om 20 kronor per aktie (den "Riktade Emissionen"), varigenom Bolaget tillförs 200 miljoner kronor före transaktionskostnader. Teckningskursen bestämdes genom ett accelererat bookbuilding-förfarande som genomfördes av Carnegie Investment Bank AB (publ) ("Carnegie"), Pareto Securities AB ("Pareto Securities"), Van Lanschot Kempen N.V. ("Van Lanschot Kempen") och Zonda Partners AB ("Zonda") som Joint Bookrunners (tillsammans "Joint Bookrunners").


Vicore has carried out a directed share issue of 10,000,000 shares at a subscription price of SEK 20 per share, raising gross proceeds of SEK 200 million

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, NEW ZEALAND, HONG KONG, JAPAN OR ANY OTHER JURISDICTION WHERE SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE UNLAWFUL OR WOULD REQUIRE REGISTRATION OR ANY OTHER MEASURES.

Stockholm, 8 December 2022 - Vicore Pharma Holding AB (publ) ("Vicore" or the "Company"), a pioneer in the development of angiotensin II type 2 receptor agonists (ATRAGs), has completed a directed share issue of 10,000,000 shares at a subscription price of SEK 20 per share (the "Directed Issue"), through which the Company receives SEK 200 million before transaction costs. The subscription price was determined through an accelerated book-building procedure conducted by Carnegie Investment Bank AB (publ) ("Carnegie"), Pareto Securities AB ("Pareto Securities"), Van Lanschot Kempen N.V. ("Van Lanschot Kempen") and Zonda Partners AB ("Zonda") as Joint Bookrunners (together the "Joint Bookrunners").


Vicore avser att genomföra en riktad nyemission av aktier

Stockholm, 7 december 2022 - Vicore Pharma Holding AB (publ) ("Vicore" eller "Bolaget"), ledande inom utveckling av angiotensin II typ 2-receptor agonister (ATRAGs), avser att genomföra en riktad nyemission av aktier motsvarande cirka 10 miljoner aktier i Bolaget genom ett accelererat bookbuilding-förfarande riktat till svenska och internationella institutionella investerare (den "Riktade Emissionen"), vilket initieras omedelbart. Vicore har anlitat Carnegie Investment Bank AB (publ) ("Carnegie"), Pareto Securities AB ("Pareto Securities"), Van Lanschot Kempen N.V. ("Van Lanschot Kempen") och Zonda Partners AB ("Zonda") som Joint Bookrunners (tillsammans "Joint Bookrunners") i samband med den Riktade Emissionen. Vicores största aktieägare, HealthCap VII L.P., har uttryckt sin avsikt att delta i den Riktade Emissionen med ett belopp om upp till 40 miljoner kronor.


Vicore meddelar att den första patienten inkluderats i COMPANION; en pivotal studie av en digital terapi för patienter med lungfibros

  • Den första randomiserade kliniska studien med en digital terapi (DTx) för att hantera de psykologiska konsekvenserna av att leva med lungfibros
  • Första patienten inkluderad i den pivotala studien som genomförs i USA. Resultat från studien förväntas under fjärde kvartalet 2023
  • Stödjer utvecklingen av en produktportfölj med ett uttalat helhetsperspektiv inom ovanliga lungsjukdomar

Stockholm, 5 december, 2022 - Vicore Pharma Holding AB (publ) ("Vicore"), ledande inom utveckling av angiotensin II typ 2-receptor agonister (ATRAGs), meddelar att bolaget lanserat den pivotala fasen av COMPANION, den första kliniska studien av en digital kognitiv beteende terapi (dKBT) för patienter med lungfibros.



Delårsrapport juli-september 2022

Stockholm, 3 november 2022 - Vicore Pharma Holding AB (publ) publicerar sin delårsrapport för tredje kvartalet 2022.


Interim report July-September 2022

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


Vicore offentliggör valberedningen inför årsstämman 2023

Göteborg, 20 oktober, 2022 - Vicore Pharma Holding AB (publ) har utsett valberedningen inför årsstämman 2023. De tre största aktieägarna per den 31 augusti 2022 har erbjudits att utse en ledamot till valberedningen vardera, i enlighet med beslutet som togs på årsstämman den 11 maj 2021.


Vicore announces the Nomination Committee for the 2023 Annual General Meeting

Gothenburg, October 20, 2022 - Vicore Pharma Holding AB (publ) ("Vicore") has appointed the Nomination Committee for the 2023 Annual General Meeting. The three largest shareholders as of August 31, 2022 have been offered to appoint a member to the Nomination Committee each, in accordance with the decision taken at the Annual General Meeting on May 11, 2021.


Vicore väljer ny ATRAG som nästa läkemedelskandidat

  • C103, en ny angiotensin II typ 2-receptor (AT2R) agonist (ATRAG), har valts som nästa läkemedelskandidat
  • Substansen har mycket hög selektivitet för AT2R över AT1R
  • En fas 1-studie är planerad att inledas under andra halvåret 2023

Göteborg, 12 oktober 2022 - Vicore Pharma Holding AB (publ) ("Vicore"), banbrytande inom utveckling av angiotensin II typ 2-receptor agonister (ATRAGs), meddelar idag att C103, bolagets tredje ATRAG, valts ut för vidare utveckling i toxikologiska studier och därefter en fas 1-studie.


Vicores digitala terapi inom IPF uppvisar nära 50% minskad ångest i pilotstudie

  • Utvärdering avseende säkerhet, funktionalitet och användarvänlighet utföll positivt
  • Rapporterad minskning av ångest för patienter med lungfibros
  • Pivotal studie i 250 patienter med lungfibros, COMPANION, planeras starta under fjärde kvartalet 2022

Göteborg, 6 oktober, 2022 - Vicore Pharma Holding AB (publ) ("Vicore") pionjärer inom utveckling av angiotensin II typ 2-receptor agonister (ATRAGs), tillkännager idag positiva resultat från pilotfasen av COMPANION-studien. Vicores digitala kognitiva beteendeterapi, AlmeeTM för patienter med lungfibros var säker, funktionell, användarvänlig och minskade rapporterade ångestsymptom med 49% hos patienter med idiopatisk lungfibros (IPF).


Vicore meddelar att C21 stimulerar kärlfunktion i människa

  • Kliniskt relevanta doser av C21 ökar blodflöde i människa
  • Det systemiska blodtrycket påverkades ej och inga biverkningar uppstod
  • Mätning av underarmens blodflöde är en robust teknik för tidig klinisk koncepttestning  

Göteborg, 22 september 2022 - Vicore Pharma Holding AB (publ) ("Vicore"), ett läkemedelsföretag i klinisk fas som utvecklar läkemedel riktade mot angiotensin II typ 2-receptorn (AT2R), meddelar idag att intraarteriell administrering av C21 resulterar i en signifikant dosberoende ökning av det lokala blodflödet.


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