BioNTech SE · NASDAQ:BNTX
BioNTech — Corporate Update (December 2020)
20 slides from BioNTech's corporate update, Dec 2, 2020
Slide 1: Update on our COVID-19 vaccine development program with BNT162b2
Update on our COVID-19 vaccine development program with BNT162b2 December 2, 2020 Exhibit 99.2
Slide 2: Forward-Looking Statements
This slide presentation includes forward-looking statements Forward-Looking Statements Various statements in this slide presentation concerning the future expectations of BioNTech, its plans and prospects, including the Company’s views with respect to its efforts to combat COVID-19; the collaboratio
Slide 3: First emergency use authorization in the world for a COVID-19 vaccine
First emergency use authorization in the world for a COVID-19 vaccine following a Phase 3 trial First deliveries in the U.K. expected within days based on existing supply agreement Received Approval for Emergency Supply in the UK for our COVID-19 mRNA vaccine BNT162b2 BioNTech will be the Marketing
Slide 4: Project Lightspeed: circa 10-month path to develop an effective vaccine
Project Lightspeed: circa 10-month path to develop an effective and well-tolerated vaccine following highly scientific and ethical standards SARS-CoV-2 Genetic Sequence Made Public January 12, 2020 COVID-19 mRNA Vaccine Program Initiation January 27, 2020 Collaborations Fosun Pharma: March 16, 2020
Slide 5: Project Lightspeed is a concerted and large-scale global effort
Project Lightspeed is a concerted and large-scale global effort 1Phase 1/2 remains ongoing in U.S. and EU Regulatory submissions on a rolling basis BioNTech and Fosun Pharma underway with Phase 2 trial of BNT162b2 Phase 3 study reached all final endpoints on Nov 18 Phase 2/31 Phase 2/31 Phase 2/3 Ph
Slide 6: BNT162b2: All primary endpoints met in Phase 3 final analysis
BNT162b2: All primary endpoints met in Phase 3 final analysis Analysis indicates efficacy rate of 95% in participants with and without prior SARS-CoV-2 infection Final analysis of unblinded data by independent data monitoring committee conducted on Nov 18, 2020 Vaccinated participants will continue
Slide 7: High efficacy and favorable safety profile for rapid and potent protection
High efficacy and favorable safety profile for rapid and potent protection Gold standard of clinical research – randomized large-scale clinical trial – to ensure safety and efficacy. We took important steps in parallel to accelerate the process together with the authorities – without shortcuts 43,00
Slide 8: COVID-19 vaccine candidate: BNT162b2 A journey from Scientific Discovery to Drug Approval
COVID-19 vaccine candidate: BNT162b2 A journey from Scientific Discovery to Drug Approval
Slide 9: What is messenger RNA?
What is messenger RNA? The first molecule of life, involved in almost all aspects of cell biology Can be synthesized and engineered to resemble mRNA molecules as they occur naturally in the cytoplasm of human cells and transiently deliver proteins of interest mRNA has a transient messenger function
Slide 10: mRNA is a natural solution for vaccines especially in a pandemic
High purity and animal material free Precision vaccine Virus-free Non-integrating into DNA Non-infectious Natural molecule studied for > 50 years with well-characterized bio-safety properties Does not require addition of adjuvants or use of a viral vector for administration Highly scalable productio
Slide 11: How mRNA vaccines work – training the immune system for a real infection
How mRNA vaccines work – training the immune system for a real infection: Both parts of the immune system activated against virus modRNA formulated in LNP enters cell 1 2 mRNA is released 3 Spike protein is made and processed 4 APCs present Spike protein fragments CD4+ Helper T Cell CD8+ Cytotoxic T
Slide 12: Mechanism of action of BNT162b2 exploits multiple levers of immune response
Mechanism of action of BNT162b2 exploits multiple levers of immune response: Strong antibody and robust T-cell responses observed Immunogenicity*3 Tolerability*4 Antibody Responses*4 T Cell Responses*5 No or only transient viral shedding in SARS-CoV-2 Virus Challenge Local reactions and systemic eve
Slide 13: Distribution of BNT162b2 vaccine
Distribution of BNT162b2 vaccine
Slide 14: Effective global distribution is only possible through effective partnerships
Effective global distribution of the BNT162b2 vaccine is only possible through effective partnerships Worldwide 50:50 partnership (except Greater China) Global pharmaceutical leader with over 88,000 employees and a presence in more than 120 countries around the world Successful track record of build
Slide 15: BNT162: Global vaccine supply commitments
BNT162: Global vaccine supply commitments* Both BioNTech and Pfizer jointly scaling up manufacturing capacity to enable global supply: BioNTech already producing vaccine for clinical supply at 2 manufacturing sites in Germany Pfizer will activate 3 manufacturing sites in the U.S. and 1 site in Europ
Slide 16: Minimal changes to pre-existing cold-chain supply: Ready for a robust UK rollout
Minimal changes to pre-existing cold-chain supply: Ready for a robust UK rollout Doses destined for the UK are manufactured in Belgium 1 2 3 4 5 Bespoke vaccine freezer boxes; each freezer box can host between approx. 1000 and 5000 doses Outer carton Rechargeable dry ice Insulation Inner carton Vacc
Slide 17: Ready to deliver – storage in boxes and regular fridge
Ready to deliver – over 30 days storage in boxes and regular fridge: BNT162b2 will be administered like many other vaccines Administration to vaccinees at room temperature Injected intramuscular (arm); no additional equipment needed for administration at mass vaccination center Storage in delivery b
Slide 18: Next steps: roll-outs in other regions of the world upon regulatory approval
Next steps: roll-outs in other regions of the world upon regulatory approval United States BioNTech MA Holder Review on Dec 10 European Union BioNTech MA Holder Review expected in Dec Canada BioNTech MA Holder + other states will follow upon regulatory approval United Kingdom BioNTech MA Holder 1st
Slide 19: Q&A
Q&A
Slide 20: BioNTech investor contact details
An der Goldgrube 12 55131 Mainz Germany T: +49 6131 9084-1074 M: investors@biontech.de