BioNTech, Cardiol Therapeutics, Bayer - Redefining the frontiers of medicine

BioNTech - Continues to invest in China

The International Agency for Research on Cancer (IARC) estimated the number of new cancer cases to be around 19.3 million for the year 2020. An increase of 56% is expected by 2040. The rising incidence is evidence of a growing market. BioNTech has been working on cancer-fighting therapies since before its Corona vaccine blockbuster. The breakthrough with Comirnaty led to high profits for the Company and its partner Pfizer, but more importantly, it opened the door for mRNA technology. This is significant because BioNTech's oncology pipeline also relies on mRNA.

Here, the Company focuses primarily on therapies for solid tumors, particularly melanoma, lung cancer and prostate cancer, as there is significant market potential. Due to its sound financial situation, BioNTech can pursue its research activities at full speed and, if necessary, purchase knowledge externally. On October 12, it was announced that the exclusive rights to HER3 targeting antibody-drug conjugate (ADC) were purchased from MediLink Therapeutics. The payment is USD 70 million in the first step but may increase to USD 1 billion if certain milestones are achieved.

This marks the fifth partnership with a Chinese company this year, and some experts see BioNTech on a similar path to Daiichi Sankyo, the second-largest Japanese pharmaceutical company, as they focus on the same receptors for ADCs. On October 13, when Pfizer lowered its revenue forecast by USD 9 billion to USD 58-61 billion, many pharmaceutical and biotech stocks experienced a downturn. BioNTech could not escape this, and the stock exited Xetra trading on Friday at EUR 101.

Cardiol Therapeutics - promising drug treating heart failure with new positive results

The number of heart disease cases is increasing worldwide. The main reasons are unhealthy diet, lack of exercise and the increasing age of the population. Cardiovascular diseases, including heart attacks and strokes, are among the leading causes of death worldwide. According to the WHO, approximately 17.9 million people die from cardiovascular disease each year. Cardiol Therapeutics has declared war on this development. Its lead product, CardiolRx™, is a pharmaceutically manufactured oral formulation based on highly purified cannabidiol (CBD) and is being developed to treat heart disease. CardiolRx™ is already in two Phase II trials for recurrent pericarditis (MAvERIC-Pilot study) and acute myocarditis (ARCHER trial).

In addition to CardiolRx™, the Company is conducting research on CRD-38, a drug for heart failure (cardiac insufficiency), which is administered subcutaneously. On October 10, the Company was able to report very positive study results. In heart failure with preserved ejection fraction, i.e. the heart is too stiff to fill properly, it was shown that the active pharmaceutical ingredient (API) in CRD-38 both slows the increase in body and heart weight and prevents an increase in inflammatory and remodeling markers of the heart. This type of heart failure is most often the result of a high-fat diet leading to an increase in visceral adipose tissue, which settles on organs such as the heart. In the US, healthcare costs due to this condition alone exceed USD 30 billion annually.

There was also a recent positive report from the ARCHER study. Patient enrollment in the acute myocarditis study is expected to be completed 6 months ahead of schedule. Cardiol Therapeutics has initiated all collaborating clinical research centers. It is now expected to have a full trial enrollment of 100 patients in Q3 2024. For those interested in learning more, watching CEO David Elsley's recent presentation from the International Investment Forum on October 10 following the news on CRD-38 is recommended. Following the announcement on October 10, the stock rose to USD 1.04 but later fell to USD 0.82, possibly due to the news from Pfizer.

Bayer - Collaboration with Twist Bioscience

Bayer is both a chemical and pharmaceutical company. Diversification can have advantages, but it can also have disadvantages. In Bayer's case, the Monsanto acquisition and resulting lawsuits have put the thoroughly successful pharma division on the back foot. On October 12, the EU Commission deliberated on extending the approval of glyphosate. After the European Food Safety Authority presented a report suggesting that glyphosate posed no significant risks, a 10-year extension seemed a mere formality. But in the end, the member states could not agree. There was neither a clear yes nor a clear no.

Once again, because of the Monsanto acquisition, we will have to wait and see what happens next. In the pharmaceutical sector, on the other hand, things are moving forward. On October 5, Bayer announced a collaboration with Twist Bioscience (Twist). *Bayer will gain access to Twist's antibody libraries and thus accelerate its drug research. In return, the Leverkusen-based company will pay up to USD 188 million, tied to milestones and royalties. Dr. Juergen Eckhardt, Head of Pharmaceuticals Business Development and member of the Pharmaceuticals Division's Executive Committee, said, "Twist Bioscience's 'library of libraries' is ideally suited to accelerate drug discovery and thus deliver meaningful benefits to patients more quickly*."

The group is also working on heart disease and, in late August, began additional studies with its drug finerenone in patients with heart failure. Bayer is also getting in on therapeutic options for cancer. Subsidiary Vividion Therapeutics started a Phase I clinical trial with its KEAP1 activator for advanced solid tumors in mid-September. The study aims to halt diseases and, ideally, provide a cure. The stock has reached its support range between EUR 43.29 and EUR 44.00 and is currently trading at EUR 43.56.

The market for biotech and pharmaceutical companies is growing. The big market potentials are in the fight against heart diseases and cancer. BioNTech has a large pipeline and is also purchasing externally to accelerate its development. Cardiol Therapeutics has two hot irons in the fire with CardiolRx™ and CRD-38. There have been very positive study results on the API in CRD-38 recently, showing that it reduces the increase in body and heart weight, which could open up a new business area. Bayer has to go an extra round of discussions with the EU Commission regarding glyphosate. In the pharmaceuticals sector, on the other hand, things are moving forward.