BioNTech, Formycon, Psybio Therapeutics: A chance for normality?

BioNTech - Vaccine also for adolescents

BioNTech SE from Mainz was in the right place at the right time. The German biotechnology company has been listed on the stock exchange since the end of 2019. It has focused on developing and producing active immunotherapies for the treatment of cancer and other serious diseases. BioNTech's main focus today is research into mRNA-based drugs. These are considered for use as individualized cancer immunotherapies, vaccines against infectious diseases and protein replacement therapies for rare diseases.

The Company caused a sensation when the Federal Republic of Germany became involved in researching a Covid vaccine very quickly. Then came the cooperation with the pharmaceutical giant Pfizer from the USA, known to everyone through the sexual enhancer Viagra. At the beginning of 2021, a Covid-19 vaccine was finally ready to be used worldwide with an efficacy of over 90%. A tremendous German success story, even if in the USA, people often only talk about Pfizer.

Now comes more good news from the USA. The manufacturers Pfizer and BioNTech want to use their Corona vaccine in the USA in adolescents aged 12 and older. An application to expand the existing emergency approval for the vaccine has already been submitted to the Food and Drug Administration (FDA). The use of the vaccine in the US has only been approved for ages 16 and older. If the approval of the authority comes, this would once again boost the all-important vaccination rate worldwide. With the news, the BioNTech share easily surpasses EUR 100 again and is heading for its old high of EUR 109.5. As a result, a new upward cycle could be initiated.

Formycon - No longer far away

There have been several announcements at Formycon in recent weeks. From a pandemic control perspective, the most important of these is that FYB207, the compound under development, is even more effective against newer, more infectious mutations of SARS-CoV-2, such as the UK variant B.1.1.7, than against earlier less infectious variants. A study published in December 2020 already showed that the efficacy of FYB207 is not affected by so-called spike protein mutations. Spike protein mutations threaten the effectiveness of both vaccines and the majority of antibodies against SARS-CoV-2.

Since we can continue to assume that governments worldwide will not implement mandatory vaccination, the combination of the lack of compulsory vaccination and the non-rare immunodeficiencies can conclude that new SARS-CoV-2 infections will persist indefinitely. Looking only at the Western Hemisphere, Europe and North America, we can continue to expect about 300,000 SARS-CoV-2-related hospitalizations per year. So there is an urgent need for drugs that both mitigate the course and reduce the rate of new infections. Formycon will make a significant contribution here.

We expect Formycon to initiate a Phase I/II study with FYB207 as early as the end of 2021. Assuming that this study's result is positive, we will very quickly apply for emergency approval for FYB207. As a result, the drug could be on the market as early as 2022. The share is currently consolidating in the EUR 58 to EUR 66 band. More news is likely to be needed for the next share price surge.

PsyBio Therapeutics Corp. - Moving forward with innovations

Florida-based PsyBio Therapeutics Corp. is moving forward. PsyBio is a biotechnology company developing novel formulations of psychoactive drugs produced by genetically engineered bacteria to treat mental and other disorders. The research team has several years of drug development experience based on synthetic biology and its clinical applications.

They have just begun collaboration with the Advanced Biofuels and Bioproducts Process Development Unit, a national laboratory of the US Department of Energy, for the process development of a proprietary biosynthetic formulation of norbaeocystin. Norbaeocystin is an analog of psilocybin and is not a controlled substance. The Company has begun Phase 1 of this process, including technical transfer of analytical chemistry. The goal here is to identify capture methods for fermentation products as well as key raw materials. Work on this is fully underway.

By continuing its efforts in this research field, PsyBio expects to begin scaling up the production of its own biosynthetic norbaeocystin in preparation for use in clinical trials in the near future. An important point here is to develop more nature-inspired psychedelic therapeutics with improved properties over psilocybin monotherapy. Potential efficacy against depression, anxiety, PTSD, and substance abuse is hypothesized and will be clinically demonstrated through the trials. For PsyBio, this would clear the way for exponential growth.

PsyBio's stock is currently trading between CAD 0.37 and CAD 0.45 in Canada. The corresponding market capitalization is about CAD 22 million. This is undoubtedly only the beginning of a longer story.