January 12th, 2022 | 11:03 CET
Valneva, Cardiol Therapeutics, Novavax: Hitting the nail on the head!
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"[...] As a company dedicated to developing treatments for rare heart diseases, we see this as an opportune moment to contribute to the fight against heart disease and make meaningful strides in improving heart health worldwide. [...]" David Elsley, CEO, Cardiol Therapeutics Inc.
Born in Munich, he first studied economics and graduated in business administration at the Ludwig-Maximilians-University in 1995. As he was involved with the stock market at a very early stage, he now has more than 30 years of experience in the capital markets.
Valneva - No one can use an announcement like this
Valneva is a French biotech company headquartered in Saint-Herblain. The Company was formed by the merger of France's Vivalis with Austria's Intercell. It develops and markets vaccines against infectious diseases and has manufacturing facilities in Austria, Scotland and Sweden, and subsidiaries in France, Canada and the United States.
Valneva, with its VLA2001 inactivated vaccine, is certainly seen by many as a beacon of hope in the pandemic. It contains the complete Sars-CoV-2 virus in an inactivated form. As a classical inactivated vaccine, it differs significantly from the widely used mRNA vaccines. Unfortunately, studies in China have failed to demonstrate much efficacy of the inactivated vaccines. The stock market punished all the dead vaccine developers. Valneva itself does not comment on these publications.
Last week, the European vaccine developer at least reconfirmed its timelines as far as clinical trials and regulatory filings for the VLA2001 vaccine are concerned. According to the statement, Valneva is targeting regulatory approval in the first quarter of 2022. The Company has started submitting applications for initial approval and aims for a green light in the EU, UK and Bahrain.
The share came under extreme pressure due to the rumors from China and lost a full 40% at the start of the year to around EUR 16. Yesterday, the value started a recovery attempt, but it is likely to remain turbulent until the approval stands. The result will be digital: Make or Break?
Cardiol Therapeutics - With full cash into Phase II
COVID-19 is much more serious for people with cardiovascular disease (CVD) than those without CVD. It is estimated that 30% to 40% of patients who die from COVID-19 respiratory disease have been exposed to cardiovascular complications. A strategy to prevent or limit the severity of these cardiovascular complications should significantly improve outcomes in curing this disease.
In September 2020, life sciences company Cardiol Therapeutics (CRDL) received approval from the US Food and Drug Administration (FDA) for its investigational new drug application to begin a double-blind, placebo-controlled Phase II/III clinical trial. The study will evaluate the efficacy and safety of its lead product, CardiolRx™, in hospitalized COVID-19 patients with a history of or risk factors for CVD. CardiolRx™ is an oral cannabidiol formulation that is pharmaceutically manufactured under CGMP regulations. Patients with COVID-19 primarily present with respiratory symptoms that can progress to bilateral pneumonia and serious pulmonary complications. It is now known that the effects of COVID-19 are not limited to the lungs, however.
Cardiol Therapeutics conducted two major capital raises in 2021, most recently raising CAD 52.4 million, with cash on hand growing to CAD 85.7 million in November. This will allow the Company to easily handle the higher costs associated with expanding recruitment for the LANCER trial in Brazil, Mexico, and Canada and continue its research and development on other products. The CRDL share rose to over EUR 4 in 2021 and is currently trading at EUR 1.52. With a market capitalization of only CAD 170 million, a sharp rebound can occur at any time on positive news.
Novavax - Approval for Covovax finally granted
Vaccination remains critical in the fight against the Corona pandemic for many countries. In the Omicron outbreak country of South Africa, Novavax has submitted an urgent application to the relevant authorities to grant emergency approval for its Corona vaccine. The Company made the application in conjunction with the Serum Institute of India, a prominent vaccine manufacturer.
If the vaccine is approved, it could be marketed and manufactured in Cape Town under the Covovax name. That would be an opportunity for the people of South Africa, as the vaccination rate is currently only about 32%. Novavax's vaccine has already received approval in more than 170 countries. In the European Union, the protein-based vaccine was recently approved as another vaccine that could convince some "vaccination skeptics" in particular - or so the government hopes in Germany as well.
According to the Rheinische Post, the vaccine from the US company should arrive in North Rhine-Westphalia as early as the beginning of February, the daily newspaper quotes a spokesperson for the NRW Ministry of Health. Shortly before Christmas, it was announced at a federal press conference that Health Minister Karl Lauterbach had ordered four million doses of the Novavax vaccine. Novavax's stock had moved down almost 50% in December 2021 due to the constant delays and falling sales estimates. Chart-wise, the EUR 112 to EUR 122 zone has become an important support area. The concluded supply contracts are probably not enough to boost the share price again.
With the Omicron variant, the virus leaves no doubt that the pandemic will rage for several more months. Stock prices of biotech stocks oscillate with incidence figures, yet the time of astronomical valuations seems to be over. The still young company Cardiol Therapeutics is already in the clinical test phase, and now things are getting really exciting.
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