Cardiol Therapeutics, BioNTech, BYD - At top speed to new markets

Cardiol Therapeutics impresses with first-class study design and international patient recruitment

Cardiol Therapeutics has made significant progress in research and development this week. The biotech company has successfully included all 35 participating heart centers in different countries in their clinical research as part of their ARCHER trial for the recruitment of subjects with acute myocarditis.

This painful heart inflammation has come to the attention of some investors in the wake of the Corona pandemic, as increased numbers of young and athletic people were affected shortly after receiving mRNA vaccinations.

The ARCHER trial has been designed in collaboration with an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence. The trial is now enrolling patients at more than 35 pre-eminent cardiovascular research centers in United States, Canada, France, Brazil, and Israel.

The ARCHER trial design meets the highest medical standards, so future results will certainly be of interest amongst cardiologists. To this end, Cardiol Therapeutics relies on a multi-center, international, double-blind, placebo-controlled study randomizing 100 patients. Studies of 100 patients or more are the basic requirement for medical relevance. Double-blinding ensures that the risk of false positives is minimized.

"The data generated from patients enrolled in ARCHER will provide important information to support the use of CardiolRx™ as a novel drug approach for this serious rare disease, which is a significant cause of acute and fulminant heart failure and is among the leading causes of sudden cardiac death in people under 35 years of age, for which there are no approved therapies," explained Andrew Hamer, MD, Chief Medical Officer and Head of Research and Development at Cardiol Therapeutics.

The team at Cardiol Therapeutics believes it has developed a significant new therapy for acute myocarditis that may also be considered for regulatory approval as an orphan drug. In the European Union, a disease is considered rare if it affects fewer than 10 in 10,000 people in the EU.

Once approved as an orphan drug, Cardiol Therapeutics could receive up to 10 years of market exclusivity for the filed indication in Europe, for example, which means that no similar drugs may be approved in the same domain during that time unless they offer significant additional benefit or help overcome a supply shortage. What the roadmap looks like will be explained live by CEO David Elsley to interested investors on October 10 as part of the 8th International Investment Forum. Click here to register.

BioNTech and CEPI partner to develop mRNA vaccine against monkeypox virus

Where there's a virus, there's a vaccine opportunity, seems to be the motto for BioNTech. The biotechnology company has announced plans to develop an mRNA vaccine against the MPox virus. This initiative is part of a partnership with the international vaccination initiative, CEPI, which BioNTech will support with up to USD 90 million, BioNTech announced this week. Last year, an outbreak of monkeypox in Europe caused a stir and led to the declaration of an international health emergency by the World Health Organization (WHO). This state of emergency was lifted in May 2023.

A Phase I/II clinical trial is currently being prepared for the vaccine program against the virus formerly known as monkeypox. Monkeypox is usually a mild viral infection associated with symptoms such as fever, headaches and skin rashes that often begin on the face and spread to the rest of the body. The viral disease occurs mainly in West and Central Africa and very rarely in other parts of the world, which made the outbreaks in Europe at the time unusual.

Most interesting to investors, BioNTech's partnership with CEPI aims to help accelerate vaccine development to prepare for regulatory approval and mass production within 100 days of identifying a potentially pandemic pathogen. Typically, it takes 10-15 years to bring a vaccine to market. Thanks to CEPI and participating countries, the public can enjoy market-ready vaccines much sooner. For those wondering where the USD 90 million came from: CEPI was founded in Davos by the governments of Norway and India, the Bill & Melinda Gates Foundation, the Wellcome Trust and the World Economic Forum.

BYD's market expansion - Europe regulates, Southeast Asia relies on partnership

Where entire nations are united in fighting viruses, the EU stands on the sidelines when competitive pressure is too strong and reacts with even more regulations. Shares of German automakers have already felt the impact of these political ambitions and barely moved since rumors began making the rounds that the EU might impose tariffs on imported Chinese electric vehicles.

Beijing criticized the planned measure as protectionist. It warned that it would damage economic ties, raising fears that China could erect its own trade barriers limiting exports of German cars to China, which are already in decline. Alternatively, punitive tariffs on imports from China could accelerate plans by Chinese electric vehicle makers to produce in Europe, analysts said, which would increase competition for domestic automakers.

Backed by subsidies, cheap access to raw materials and technical know-how developed through early investments in electric cars, Chinese electric vehicle makers like BYD have significantly lower production costs than their Western counterparts.

Meanwhile, BYD continues to conquer the Southeast Asian market and has surpassed Tesla there, accounting for a quarter of the EVs sold in the region. Along with attractive pricing, BYD's early success stems from a strategy of distribution partnerships with large, local conglomerates that have allowed the automaker to expand its reach, test consumer preferences and navigate complex government regulations in the region, analysts said.

This partnership model, similar to that pursued by Japanese automakers decades ago in some Southeast Asian countries, helps BYD build market share quickly and contrasts with Tesla's standalone sales approach - though it comes at a price. "Currently, BYD is mainly focused on brand extension rather than optimizing profit margins," said Soumen Mandal, senior analyst at Counterpoint Research. "By offering more lucrative profit margins to local dealers, BYD can build trust and loyalty and pave the way for broader expansion." BYD shares currently stand at EUR 28.45.

Cardiol Therapeutics impresses with excellent science, and investors will be pleased to learn that the ARCHER trial is now being rolled out internationally at 35 cardiac centers, adhering to the highest medical and scientific standards, in order to reach the target of 100 patients. With future results, the Company achieves another important milestone in the planned approval of CardiolRx™ as an orphan drug in the US and Europe. Interested investors can submit questions to CEO David Elsley live online at the 8th International Investment Forum. Interested investors can register here. German biotech company BioNTech is also pleased to announce a USD 90 million investment to accelerate vaccine development against monkeypox. What previously took 10-15 years to develop in the pharmaceutical pipeline is expected to receive market approval within 100 days in the future. It remains to be seen how this will work out in concrete terms in terms of side effects and how they will be recorded. Numerous nations agree on the fight against viruses, but when it comes to expanding market shares in the automotive sector, territorial rights take effect - at least in the case of the EU, which would like to make trade more difficult for the Chinese carmaker BYD by imposing tariffs. BYD, on the other hand, is diligently expanding its market share in Southeast Asia and relies on collaborative business relationships, while the EU would prefer to restrict BYD with tariffs or new regulations. Instead of letting consumers decide, Brussels would rather dictate how things should proceed.