BioNTech : J.P. Morgan Presentation

J.P. Morgan Healthcare Conference

January 2020

Ugur Sahin, MD

CEO and Co-Founder

Titelmasterformat durch Klicken bearbeiten

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 the potential for mRNA therapeutics, its expectations with respect to the timing and results of clinical trials and release of clinical data (both in respect of its proprietary product candidates and of product candidates of its collaborators), the development of commercial capabilities and the transition of BioNTech to a fully integrated biopharmaceutical company, its expectations with respect to interactions with regulatory authorities such as FDA and EMA, including the potential approval of BioNTech's or its collaborators' current or future drug candidates, and expected royalty and milestone payments in connection with BioNTech's collaborations, constitute forward-looking statements. Words such as "expects," "plans," "potential," "target," "continue" and variations of these words or similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Such statements are based on the current beliefs and assumptions of the management team of BioNTech and on the information currently available to the management team of BioNTech, and are subject to change. The Company will not necessarily inform you of such changes. These forward looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that could cause the Company's actual results, performance or achievements to be materially different than any future results, performance or achievements expressed or implied by the forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including the initiation, timing, progress, results and cost of the Company's research and development programs and its current and future preclinical studies and clinical trials; the timing of and the Company's ability to obtain and maintain regulatory approval for its product candidates; the Company's ability to identify research opportunities and discover and develop investigational medicines; the Company's expectations regarding the size of the patient populations for its product candidates, if approved for commercial use; the Company's estimates of its expenses, ongoing losses, future revenue and capital requirements and its needs for or ability to obtain additional financing; the Company's ability to identify, recruit and retain key personnel; the Company's and its collaborators' ability to protect and enforce its intellectual property protection for its proprietary and collaborative product candidates, and the scope of such protection; the development of and projections relating to the Company's competitors or its industry; the Company's ability to commercialize its product candidates, if approved; the rate and degree of market acceptance of the Company's investigational medicines; the Company's ability to manage its development and expansion; regulatory developments in the United States and foreign countries; the Company's ability to manufacture its product candidates with advantages in turnaround times or manufacturing cost; and the Company's ability to implement, maintain and improve effective internal controls. The preceding list is not intended to be an exhaustive list of all of the Company's forward-looking statements. Any forward-looking statements represent the Company's views only as of today and should not be relied upon as representing its views as of any subsequent date. The Company explicitly disclaims any obligation to update any forward-looking statements. The mRNA vaccines and other product candidates discussed in this slide presentation are investigational products being developed by BioNTech and its collaborators and are not currently approved by the FDA, EMA or any other regulatory authority.

2

Titelmasterformat durch Klicken bearbeiten

Agenda

Who we are and what we do

Our platforms and programs

+

Outlook for 2020 and beyond

3

ExecutiveTit lmasterformatsummarydurch Klicken bearbeiten

Building a 21stcentury individualized immunotherapy company

Next generation immunotherapies for cancer and other diseases

• Technology agnosticapproach
• Exploitingnoveltargets and mechanisms
• Vertical Integrationwith in house

manufacturing

Broad & diversified pipeline

• 10product candidates in the clinic
• Firstregistrational trial expected to start in20202

World-leading collaborators

• 7 pharmaceutical collaboratorsand multiple leading academic institutions
• 50:50 cost and profit share agreementswith leaders in oncology1

Large addressable market opportunity in solid tumors

• More thanUSD 90bn solid tumor market3addressed
• Commercialization orco-commercialization rights retained in key geographies

Up to 7 clinical data updates expected in the next 18 months

4	1with Genentech and Genmab; 2BNT111; 3Source: Global Data Total WW Market, top 10 available products 2018-2024 + other

OverviewTit lmasterformat durch Klicken bearbeiten

Our Vision: We aspire to individualize cancer medicine

Clinical samples

Interindividual variability

Tailored-on-demand immunotherapies

5

Sample profiling

bioinformatics	Drug classes
big data, deep data
AI platforms

A patient centric approach

Off-the-shelf drugs

mRNA Therapeutics

Engineered

Cell Therapies

Antibodies

Small Molecule Immunomodulators

In-house diagnostics & bio- informatics

Multi-drug platform approach

Off-the-shelf drugs and individualized therapies

In-house manufacturing with on- demand production capabilities

StrategicTitelmasterformatcollaborationsdurch Klicken bearbeiten

We collaborate with global leaders in our industry

Oncology Collaborations with at least one program in the clinic

50:50

Cost and Profit share (2016)

50:50

Cost and Profit share (2015)

Cost and Profit share (2015)

Other Oncology, Infectious Diseases and Rare Diseases Collaborations

Co-development	Licensing Agreement	Strategic R&D	R&D Agreement	Licensing Agreement
Co-commercialization (2018)	(2018)	Alliance (2018)	(2019)	(2015)

UPenn

6

OurTitelmultiasterformat-platformdurchapproachKlicken bearbeiten

Our IO strategy exploits complementary therapeutic platforms

mRNA Cancer

In the clinic

Next Generation

Vaccines

1

1

Immunomodulators

FixVac, iNeST

Bispecific Antibodies

(CPI + co-stimulation)

2020

+



Engineered

1

1

Engineered

Cell Therapies



2020

Cytokines

CAR-T, TCRs

Intra-tumoral cytokines

Small Molecule

Antibody Targeting

RiboCytokines

Immunomodulators

Targeted Antibodies

TLR agonist

RiboMabs

We expect to have all core platforms in the clinic by the end of 2020

7

SolidTitelmasterformattumor marketdurchsegmentationKlicken bearbeiten

A technology agnostic approach increases our addressable market

Cancer segment	Patient Population	Challenge	Our Therapeutic Strategy
High mutational burden/	Significant portion	Poor risk-benefit profile of	•	mRNA Neoantigen
adjuvant stage cancers	of cancer patients	checkpoint inhibitors		Immunotherapy (iNeST)
Low mutational burden	>60% of cancers	Poor response to	•	Shared Antigens
cancers	checkpoint inhibitors		(FixVac, CAR-T cells, Antibodies)
		>40% of high-mutational	Poor infiltration and	•	mRNA Immunotherapy
"Immune desert" cancers	•	Immunostimulatory Compounds
cancers	activation of T-cells in TME1
			(intratumoral, RiboCytokines)
Cancers with MHC / B2M	20-30% of CPI-experienced	Failure of immune system	•	Antibodies
loss	advanced cancers	to recognize tumor cells	•	CAR-Ts
		Patients with large tumors
			•	Engineered Cell Therapies
Refractory tumors	and multiple resistance	Few treatment options
•	Combination Therapies
		mechanisms

Portfolio approach based on molecular classification and segmentation of cancer types

8	1Tumor microenvironment

mRNATitelmasterfplatformr at durch Klicken bearbeiten

One of the broadest mRNA toolkits in the industry

Multiple mRNA formats

Broad formulation spectrum

5' Cap 5' UTR

ORF

3' UTR Poly(A) tail

• Liposomes / LPX

•	uRNA	•	saRNA			LNPs
		Polyplexes
•	modRNA	•	taRNA

Various delivery routes

• Local
• Intratumoral
• Systemic
• Tissue specific

Adjustable activity in vivo from minutes up to weeks

9

OurTitelmasterformatpipelinedurch Klicken bearbeiten

Additional late stage trial starts planned for FixVac and iNeST in 2020

Drug		Product			Rights
Class	Platform	Candidate	Indication (Targets)	Preclinical Phase 1 Phase 2 Collaborator	Milestones
Oncology
			BNT111	advanced melanoma		fully-owned	report phase 1 data and phase 2 start 1H
			(adjuvant & metastatic)		2020;phase 3 start 2H 2020
							first patient enrolled in phase 1/2	new
			BNT112	prostate cancer		fully-owned
				in Dec 2019 (plan: 2H 2019)
		FixVac	BNT113	HPV16+ head and neck		fully-owned	phase 2 start 2H 2020
		(fixed combination	cancer1
		of shared non-mutated	BNT114	triple negative breast cancer		fully-owned	data update 1H 2020
		cancer antigens)
mRNA						fully-owned
		BNT115	ovarian cancer1		first patient dosed in Dec 2019	new
						fully-owned
			BNT116	NSCLC		-	new
		iNeST		1L melanoma with CPI2		Genentech	top line data 2H 20203
		(patient specific cancer	RO7198457
				(global 50:50
		mutated antigen	(BNT122)
		multiple solid tumors		profit/loss)	data update 2020
		therapy)
						Sanofi
		Intratumoral	SAR441000	solid tumors (IL-12sc,		data update 2H 20204
			(global profit/ loss
		Immunotherapy	(BNT131)	IL-15sushi,GM-CSF, IFNα)
			share)

1BNT113 and BNT115 are currently being studied in an investigator-initiated phase 1 trials; 2Checkpoint Inhibitor; 3We expect this topline data update to include an update on the ongoing

10study, including patient enrollment numbers, with full efficacy and safety data for an interim update expected in the second half of 2021; 4As the trial is sponsored and conducted by Sanofi, the timing of data updates is not under our control, and is subject to change by Sanofi.

OurTitelmasterformatoncology pipelinedurch Klicken bearbeiten

We plan to start first-in-human trials for RiboMabs & RiboCytokines in 2020

Drug		Product					Rights
Class	Platform	Candidate	Indication (Targets)	Preclinical	Phase 1	Phase 2	Collaborator	Milestones
Oncology
	RiboMabs	BNT141	multiple solid tumors				fully-owned	phase 1 start 2H 2020
	(mRNA-encoded
	antibodies)	BNT142	multiple solid tumors				fully-owned	phase 1 start 2H 2020 or 1H 2021
mRNA		(CD3+CLDN6)
	BNT151	multiple solid tumors				fully-ownedphase 1 start 1H 2020
	RiboCytokines	(optimized IL-2)
	(mRNA-encoded
	Cytokines)	BNT152+	multiple solid tumors				fully-owned	phase 1 start 2H 2020 or 1H 2021
		BNT153	(IL-7,IL-2)

11

OurTitelmasterformatoncology pipelinedurch Klicken bearbeiten

We now have 3 antibodies in clinical testing

Drug		Product			Rights
Class	Platform	Candidate	Indication (Targets)	Preclinical Phase 1 Phase 2 Collaborator	Milestones
Oncology
			BNT211	multiple solid tumors		fully-owned	phase 1/2 start 1H 2020
			(CLDN6)
EngineeredCell Therapies
	CAR-T Cells	BNT212	pancreatic, other cancers		fully-owned	-
		(CLDN18.2)
						Eli Lilly
			Undisclosed	undisclosed		-
				(exclusive license)
		TCRs
		To be	all tumors		fully-owned	-
			selected
			GEN1046	multiple solid tumors			data update 1H 2021
Antibodies		Next-Gen CP5	(BNT311)	(PD-L1×4-1BB)		Genmab
	Immunomodulators				(global 50:50
	GEN1042	multiple solid tumors
			profit/loss)	-
			(BNT312)	(CD40×4-1BB)
		Targeted Cancer	BNT321	pancreatic cancer (sLea)		fully-owned	patient enrolled to resume phase 1	new
		Antibodies	(MVT-5873)		in Dec 2019
SMIM6		Toll-Like	BNT411	solid tumors (TLR7)		fully-owned	phase 1 start 1H 2020
	Receptor Binding

5Checkpoint; 6Small Molecule Immunomodulators

12

YearTitelmasterformatin reviewdurch Klicken bearbeiten

2019 Highlights

Pipeline

• Initiated clinical trials for 6 Investigational Medicinal Products (IMPs) across various cancer indications
• Started first randomized Phase 2 trial for iNeST
• Dosed more than 440 patients across all BNTX programs1as of end 2019

Corporate

• Raised $225m in Series B financing and $149m in Nasdaq IPO
• Signed two additional agreements with Bill & Melinda Gates Foundation and Regeneron
• Purchased site for building new iNeST manufacturing facility and initiated planning and design work

Management Team

• Agreed on new Management Board Member and Chief Strategy Officer (appointment of Ryan Richardson on Jan 12, 2020)

131BNTX programs: all BioNTech trials including trials sponsored by collaborators

Titelmasterformat durch Klicken bearbeiten

Agenda

Who we are and what we do

Our key platforms and programs

mRNA vaccines - FixVac and iNeST

Antibodies

CARVac platform - CLDN6 CAR-T

RiboCytokines

Outlook for 2020 and beyond

14

mRNATitelmasterformatdrug class |durvaccineh Klickenplatformsbearbeiten

Our mRNA vaccine platforms: FixVac and iNeST

FixVac		iNeST

Off-the-shelf mRNA immunotherapyFully individualized mRNA immunotherapy

Targeting a fixed combination of shared antigens	Targeting 20 neo-antigens unique to each patient
−Non-mutated antigens shared among patients with a specific	−	Vast majority of neo-antigens are unique to individual patients
cancer type	−	Applicable across solid tumor types

• Applicable for almost all types of tumor antigens
• • ProprietaryRNA-LPX formulation for systemic dendritic cell targeting
  • Strong immunogenicity observedin vivovia TLR7-driven adjuvant effect
  • Potent induction of strongex vivoCD4+ and CD8+ T cell responses

15

Kranz et al., Nature 2016

mRNATitelmasterformatdrug classdur| vaccineh Klickenplatformsbearbeiten

Our RNA-LPX vaccine approach

Strong vaccine-inducedex vivoCD8+ T cell responses1across different cancer types

10.1%

2.1%

5.0%

10.3%

.

NY-ESO-1	MAGE-A3	HPV16-E7	Mutant Neoantigen
Melanoma	Melanoma	Head Neck Cancer	TNBC
BNT111, Lipo-MERIT trial	BNT111, Lipo-MERIT trial	BNT113, HARE40 trial	BNT114, TNBC MERIT trial

FixVac

iNeST

16	1T cell responses analyzed by ex vivomultimer staining analysis in blood

mRNATitelmasterformatdrug class |durchFixVacKlickenplatformbearbeiten| BNT111 (FixVac advanced melanoma)

FixVac: BNT111 interim clinical activity data (dose range 14µg -100µg)

Summary

• Advanced melanoma patients (Stage IIIB,C, Stage IV)
• Out of74 patientswith follow-up imaging 42 patientswere eligible for exploratory analysis of objective responses as of July 29, 2019
• 25 patientswith pretreated andCPI1-experienced metastatic melanoma who received BNT111 monotherapy
• • 3 patients with partial response (PR)
  • 1 with metabolic complete remission2
  • 7 patients with stable disease (SD)
  • 14 progressive disease (PD)

• 17 patientswithCPI-experienced metastatic melanoma who received BNT111 in combination with CPI
• • 6 patients with partial response (PR)
  • 2 patients with stable disease (SD)
  • 9 patients with progressive disease (PD)

Shared Antigens Targeted

NY-ESO-1 /MAGE-A3 / Tyrosinase / TPTE

• Adjuvant cohort of 32 patients still in study

17	1CPI = Checkpoint Inhibitor, 2based on 18F-FDG-PET/CT analysis

mRNATitelmasterformatdrug class |durchFixVacKlickenplatformbearbeiten| BNT112 (FixVac prostate cancer)

BNT112: FixVac Prostate Cancer

Antigen 1

PSA

PAP

Antigen 4

Antigen 5

Antigen 1

PSA

PAP

Antigen 4

Antigen 5

Ph1/2: first patient enrolled in December 2019

• Multipronged vaccine: Targeted antigens of BNT112 are 5 prostate cancer specific antigens (PAP, PSA and 3 undisclosed antigens)
• RNA-LPXvaccine format validated by our FixVac Melanoma program

18

mRNATitelmasterformatdrug class |durchFixVacKlickenplatformbearbeiten

FixVac: an expanding pipeline of clinical stage programs

Product	Preclinical	Phase 1	Phase 2
candidate

BNT111

BNT113

BNT114

FixVac Pipeline

BNT112

Advanced melanoma

HPV positive

head & neck cancer (IIT)

Triple negative breast cancer

Prostate cancer

Ph. 3 start H2 2020

Ph. 2 start 2H 2020

5 programs in human trials

BNT115	Ovarian cancer (IIT)

BNT116 NSCLC

19

mRNATitelmasterformatdrug class durch| iNeSTKlickenplatformbearbeiten| clinical trials

Conclusions from iNeST clinical trials

Long-termfollow-up of completed trial with BNT121 (Intra-nodal administration, RNA):

• Long-termrelapse free disease activity with BNT121 iNeST in adjuvant melanoma

Preliminary observations in ongoing trials with BNT122 (RO7198457) (IV administration, RNA-LPX):

• iNeST can be manufactured for individual patients with clinically relevantturn-around times across a range of tumor types
• iNeST +/- atezolizumab (Tecentriq) has a manageable safety profile
• Strong iNeST immunogenicity across a range of tumor types

Clinical efficacy evaluation in randomized phase 2 trials initiated

20

mRNATitelmasterformatdrug class |durchiNeSTKlickenplatformbearbeiten| clinical trials

Update for BNT121 (as of October 2019)

Melanoma Stage IIIb, IIIc, and IV, 13 patients, intranodal delivery against 10 neoantigens

Metastatic relapse analyses			9 of 13 patients without
				documented PFS Events

Stable progression free survival in adjuvant melanoma

21	Sahin et al., Nature 2017

SolidTitelmasterformattumor marketdurch Klicken bearbeiten

A technology agnostic approach increases our addressable market

Cancer segment	Patient Population	Challenge	Our Therapeutic Strategy
High mutational burden/	Significant portion	Poor risk-benefit profile of	•	mRNA Neoantigen
adjuvant stage cancers	of cancer patients	checkpoint inhibitors		Immunotherapy (iNeST)
Low mutational burden	>60% of cancers	Poor response to	•	Shared Antigens
cancers	checkpoint inhibitors		(FixVac, CAR-T cells, Antibodies)
		>40% of high-mutational	Poor infiltration and	•	mRNA Immunotherapy
"Immune desert" cancers	•	Immunostimulatory Compounds
cancers	activation of T-cells in TME
			(intratumoral, RiboCytokines)
Cancers with MHC / B2M	20-30% of CPI-experienced	Failure of immune system	•	Antibodies
loss	advanced cancers	to recognize tumor cells	•	CAR-Ts
		Patients with large tumors
			•	Engineered Cell Therapies
Refractory tumors	and multiple resistance	Few treatment options
•	Combination Therapies
		mechanisms

Portfolio approach based on molecular classification and segmentation of cancer types

22

mRNATitelmasterformatdrug class |durchiNeSTKlickenplatformbearbeiten| clinical trials

Individualized Neoantigen Specific Immunotherapy (iNeST)

Preclinical

Phase 1

Phase 2

Turnaround

time reduced

from three

months to six

weeks

Overview

• Targeting multiple neoantigens
• Intended to be a universal approach applicable for the majority of cancers
• 50:50 profit/loss share with Genentech

BNT121

(i.n.)

BNT122

(IV)

Metastatic melanoma (N=13)

Multiple solid tumors

First-line advanced melanoma in combination with pembrolizumab (Keytruda)

First-line adjuvant solid cancer in combination with atezolizumab (Tecentriq)

First-line adjuvant solid cancer

Up to 41 mon follow-up data

Data update 2020

Top line data

2H 2020

New planned trial expected to start in 2020

Currently

being

evaluated in

• 8 solid tumor indications

23

mRNATitelmasterformatdrug class |durchiNeSTKlickenplatformbearbeiten| clinical trials

Digitization and automation for neo-antigen vaccine manufacturing

Paperless documentation

Semiautomatic manufacturing

• 2 mRNA GMP production facilities:Idar-Oberstein (GMP since 2011) and Mainz (GMP since 2018)
• Construction and GMP licensure of new Mainz facility for iNeST expected in 2022/2023
• Partnered with Siemens to develop automated production processes

24

Titelmasterformat durch Klicken bearbeiten

Agenda

Who we are and what we do

Our platforms and programs

mRNA vaccines - FixVac and iNeST Antibodies

CARVac platform - CLDN6 CAR-T RiboCytokines

Outlook for 2020 and beyond

25

AntibodiesTitelmasterformatdrug classdurch| bispecificKlicken bearantibodieseiten

Next-Gen checkpoint immunomodulators

Two bispecific antibodies partnered with Genmab

• Potential"first-in-class" bispecific antibodies
• Conditional activation ofimmuno-stimulatory checkpoint activity
• 50:50 profit/loss share
• Both programs are now in the clinic

PD-L1

4-1BB

CD-40

4-1BB

L234F

Fc-

L234F

Fc-

silencing

silencing

L235E

L235E

mutations

mutations

D265A

D265A

matched CH3

matched CH3

mutations

mutations

K409R

K409R

F405L

F405L

Product		Phase 1
Candidate	Preclinical	Phase 2
BNT311		PD-L1x4-1BB	Ph1/2a	Data update
(GEN1046)			1H 2021
BNT312		CD-40x4-1BB	Ph1/2a
(GEN1042)

26

TitelmasterformatAntibodies drug classdurch| bispecificKlicken bearantibodieseiten| anti-PDL1,anti-4-1BB

Next-Gen checkpoint immunomodulators

Characteristics

Mode of Action

Constitutive PD-L1 blockade &

1Conditional 4-1BB agonism

• Bi-specificantibody combining constitutive CPI blockade and conditional co-stimulatory activity
• Enhanced proliferation of antigen specific activated T cells in the presence ofPD-L1-positive cells

PDL1 Blockade

		8
o n	e )	6
t i	s
c t i v a	c r e a	4
a	i n
c e l l	o l d	2
	f
T	(
		0
		0	. 0 0 1	0	. 0 1	0 . 1	1	1 0		1 0 0
		A n t i b o d y	c o n c e n	t r a t i o n	( μg / m L	)
		P D - L 1 x 4 - 1 B B					A n t i - P D	- L 1
	A n t i - P D - L 1	( p a r e n	t a l )			I s o t y p e		c o n t r o l

		7 5	41BB Agonism
t i o n	s e )	5 0
c t i v a	c r e a
a	i n
e l l	l d	2 5
c	o
T	( f
		0

0 . 0 0 1	0 . 0 1	0 . 1	1
A n t i b o d y c o n c e n t r a t i o n ( µ g / m L )
P D - L 1 x 4 - 1 B B		P D - L 1 x C o n t r o l
			C o n t r o l x 4 - 1 B B

Increased tumor infiltrating lymphocyte (TIL) expansion

2in human tumor tissue cultures ex vivo

Induced tumor regression of

Preclinical antitumor activity beyond PDL1 blockade

3	murine tumors superior to pure
PD-L1 blockage associated with

an increase in tumor-specific CD8 T-cells

27	*SITC 2018, Altintas et al

SolidTitelmasterformattumor marketdurch Klicken bearbeiten

A technology agnostic approach increases our addressable market

Cancer segment	Patient Population	Challenge	Our Therapeutic Strategy
High mutational burden/	Significant portion	Poor risk-benefit profile of	•	mRNA Neoantigen
adjuvant stage cancers	of cancer patients	checkpoint inhibitors		Immunotherapy (iNeST)
Low mutational burden	>60% of cancers	Poor response to	•	Shared Antigens
cancers	checkpoint inhibitors		(FixVac, CAR-T cells, Antibodies)
		>40% of high-mutational	Poor infiltration and	•	mRNA Immunotherapy
"Immune desert" cancers	•	Immunostimulatory Compounds
cancers	activation of T-cells in TME
			(intratumoral, RiboCytokines)
Cancers with MHC / B2M	20-30% of CPI-experienced	Failure of immune system	•	Antibodies
loss	advanced cancers	to recognize tumor cells	•	CAR-Ts
		Patients with large tumors
			•	Engineered Cell Therapies
Refractory tumors	and multiple resistance	Few treatment options
•	Combination Therapies
		mechanisms

Portfolio approach based on molecular classification and segmentation of cancer types

28

AntibodiesTitelmasterformatdrug classdurch| targetedKlick nantibodiesbearbeit n| anti-CA19.9

BNT321: Cancer antibody targeting Cancer Associated Carbohydrate sLea

Characteristics

• Fully human IgG1 mAb with subnanomolar affinity, potent cell killing by ADCC &CDC activity.
• Targets sialyl Lewis A epitope (sLea) epitope present in a range ofglyco-proteins collectively known as CA19-9
• CA19-9is specifically expressed in pancreatic and various other cancers. Shedded CA19-9 is a prognostic marker in these cancers
• CA19-9is functionally associated with carcinogenesis1

Preliminary data

• Six patients evaluated in combination with chemotherapy; four of them met the criteria for partial response and two patients met the criteria for stable disease. BNT321 was generally well tolerated by all six patients
• First patient enrolled to resume the BNT321 trial against pancreatic cancer in December 2019

sLeaexpression in human cancers

1. Pancreatic ductal adenocarcinoma
2. Colon carcinoma
3. Lung adenocarcinoma
4. Urinary bladder, mucinous adenocarcinoma
5. Colon metastatic to ovary
6. Breast carcinoma, lymph node

			Phase 1	resumed
BNT321		sLea
(MVT-5873)		in 2H 2019

29	1Engle et al, Science 2019: The glycan CA19-9 promotes pancreatitis and pancreatic cancer in mice	AACR 2016, Abstract CT026, Ragupathi_Maffuid

Antibodies drug class | targeted antibodies | anti-CA19.9

First-in-human Ph1 trial also supports theranostic potential

PET/CT imaging study with MVT-2163 (PET conjugated Ab version; 89Zr-DFO-HuMab-5B1)

• Robust accumulation in tumors lesions; tumor uptake increasing over time.
• Validates the target and the antibody and indicates utility of BNT321 also for detection byradio-imaging and for radiotherapy.

30	Lohrmann et al., Clin Cancer Res, 2019 in press

Titelmasterformat durch Klicken bearbeiten

Agenda

Who we are and what we do

Our platforms and programs

mRNA vaccines - FixVac and iNeST Antibodies

CARVac platform - CLDN6 CAR-TRiboCytokines

Outlook for 2020 and beyond

31

EngineeredTitelmast rformatCell Therapiesdu ch Klicken| CARbearb-T therapiesiten| BNT211

BNT211: Next generation CAR-T targeting CLDN6 with CARVac "primer"

CLDN6 is notpresent in healthy tissues

CLDN6 is expressed in multiple cancers

CAR-T cell therapy + RNA Vaccine to amplify CAR-T cell in vivo

Ovarian cancer Testicular tumor Lung cancer

Complete eradication of advanced tumors demonstrated in an ovarian carcinoma xenograft model

32

EngineeredTitelmast rformatCell Therapiesdu ch Klicken| CARbearb-T therapiesiten| BNT211

BNT211: Next generation CAR-T targeting CLDN6 with CARVac "primer"

t o t a l f l u x [ p / s ]

1 ° 2 ° 3 °

4 °

5 ° R N A ( L I P )v a c c i n a t i o n

1 0 8

1 0	7
	C L D N 6 R N A ( L I P )

c t r l R N A ( L I P )

1 0 6

0

1 0

2 0

3 0

4 0

5 0

6 0

7 0

8 0

9 0

d a y s p o s t A C T

Applicability shown for CLDN6, CLD18.2, CD19 CAR-T cells

RNA-lipoplex vaccine enhances expansion & persistence of CAR T

33	1Reinhard et al, Science 2020: An RNA vaccine drives expansion and efficacy of claudin-CAR-T cells against solid tumors

SolidTitelmasterformattumor marketdurch Klicken bearbeiten

A technology agnostic approach increases our addressable market

Cancer segment	Patient Population	Challenge	Our Therapeutic Strategy
High mutational burden/	Significant portion	Poor risk-benefit profile of	•	mRNA Neoantigen
adjuvant stage cancers	of cancer patients	checkpoint inhibitors		Immunotherapy (iNeST)
Low mutational burden	>60% of cancers	Poor response to	•	Shared Antigens
cancers	checkpoint inhibitors		(FixVac, CAR-T cells, Antibodies)
		>40% of high-mutational	Poor infiltration and	•	mRNA Immunotherapy
"Immune desert" cancers	•	Immunostimulatory Compounds
cancers	activation of T-cells in TME
			(intratumoral, RiboCytokines)
Cancers with MHC / B2M	20-30% of CPI-experienced	Failure of immune system	•	Antibodies
loss	advanced cancers	to recognize tumor cells	•	CAR-Ts
		Patients with large tumors
			•	Engineered Cell Therapies
Refractory tumors	and multiple resistance	Few treatment options
•	Combination Therapies
		mechanisms

Portfolio approach based on molecular classification and segmentation of cancer types

34

EngineeredTitelmast rformatCell Therapydu ch KlickenManufacturingbea beiten

Further development of engineered T cell therapies

Key Plans

• Startfirst-in-human trial for CLDN6 CAR-T in solid tumors
• SecondCAR-T in pipeline for solid tumors: CLDN18.2 CAR-T
• Develop CARVac with otherCAR-T therapies
• Plan to announce first TCRs for TCR engineered therapies
• Expansion of certified GMP T cell manufacturing facilities planned to be completed in 2020

C		D					Idar-Oberstein: GMP certified Cell Therapy
					Manufacturing
							Front view model of final layout with the existing
						A
						buildings A/B and the new buildings C and D
							(D behind B).
				B

35

Titelmasterformat durch Klicken bearbeiten

Agenda

Who we are and what we do

Our platforms and programs

mRNA vaccines - FixVac and iNeST Antibodies

CARVac platform - CLDN6 CAR-TRiboCytokines

Outlook for 2020 and beyond

36

SolidTitelmasterformattumor marketdurch Klicken bearbeiten

A technology agnostic approach increases our addressable market

Cancer segment	Patient Population	Challenge	Our Therapeutic Strategy
High mutational burden/	Significant portion	Poor risk-benefit profile of	•	mRNA Neoantigen
adjuvant stage cancers	of cancer patients	checkpoint inhibitors		Immunotherapy (iNeST)
Low mutational burden	>60% of cancers	Poor response to	•	Shared Antigens
cancers	checkpoint inhibitors		(FixVac, CAR-T cells, Antibodies)
		>40% of high-mutational	Poor infiltration and	•	mRNA Immunotherapy
"Immune desert" cancers	•	Immunostimulatory Compounds
cancers	activation of T-cells in TME
			(intratumoral, RiboCytokines)
Cancers with MHC / B2M	20-30% of CPI-experienced	Failure of immune system	•	Antibodies
loss	advanced cancers	to recognize tumor cells	•	CAR-Ts
		Patients with large tumors
			•	Engineered Cell Therapies
Refractory tumors	and multiple resistance	Few treatment options
•	Combination Therapies
		mechanisms

Portfolio approach based on molecular classification and segmentation of cancer types

37

RiboCytokinesTitelmasterformat durch Klicken bearbeiten

RiboCytokines: a novel therapeutic platform

The Concept

• Cytokines encoded by mRNA and produced in the patient
• Improved PK properties to improve tolerability and activity
• Cytokine design to improve immunological properties and tolerability

Therapeutic Goals

Pharmacokinetic Profile

Recombinant cytokine

RiboCytokine

• Overcome resistance mechanisms

by therapeutic synergy

Product

Preclinical

Phase 1

Phase 2

Improve activity of mRNA

Candidate

k

Expected to enter

Vaccines

BNT151

Optimized IL-2

the clinic in 1H 2020

Worldwiderights; wholly owned

BNT152 /

IL-7,IL-2

Expected to enter

BNT153 combo

the clinic in 2H 2020

38

RiboCytokinesTitelmasterformat durch Klicken bearbeiten

RiboCytokines boost clinical activity of vaccination and PD-L1 blockade

Vaccine + aPD-L1 +

Vaccine + aPD-L1 (5mm2)

Vaccine + aPD-L1 (60mm2)

survival	100
75
Percent	50
25

0

0 20 40 60 80 100 120 Days after tumor inoculation

CT26 tumor model, vaccine antigen: gp70

		Vaccine + aPD-L1 +
2048	Control
CR 2/11
1024
3	512
)
(mm	256
size	128
64
Tumor	32
16
	8
	4
	2
		Vaccine + aPD-L1 +
	2048	IL7
	CR 3/11
	1024
3	512
)
(mm	256
size	128
64
Tumor	32
16
	8

4

2

0 25 50 75 100

Days after tumor inoculation

Vaccine + aPD-L1 +

IL2

CR 6/11

Vaccine + aPD-L1 +

IL2 + IL7

CR 11/11

0 25 50 75 100

Days after tumor inoculation

Percent survival

Vaccine + aPD-L1+

Control

IL2

IL7

IL2 + IL7

100 75 50 25

0
0	25	50	75	100	125
	Days after tumor inoculation

CT26 tumor model, tumor size: 60mm2

CR: complete response, vaccine antigen:gp70

Effect of tumor size on treatment success of vaccination + aPD-L1

RiboCytokines boost the clinical activity of vaccination

+ aPD-L1 in large tumors

39

OurTitelmultiasterformat-platformdurchapproachKlicken bearbeiten

Multiple angles for therapeutic synergy across platforms

Approved PD1/PL1

Inhibitors

+

mRNA Cancer

Vaccines

• FixVac Melanoma (BNT111):Induces objective responses in CPI- experienced patients
• iNeST (BNT122):Currently in Phase 2 in combination with CPI in 1L Melanoma. 2 adjuvant trials planned in 2020

mRNA Cancer

Vaccines

+

Engineered

Cytokines

• RibocytokineIL-2 (BNT151): Amplification of vaccine induced T cell response inpre-clinicalstudies

Engineered

Cell Therapies

+

mRNA Cancer

Vaccines

• BNT211:First-of-kindCLDN-6CAR-T approach utilizing CAR-TAmplifying RNA Vaccine (CARVac). Significant amplification of CAR-T cells in preclinical studies (published in SCIENCE, 2020)

Broad therapeutic potential across a range of solid tumors

40

Titelmasterformat durch Klicken bearbeiten

Agenda

Who we are and what we do

Our platforms and programs

+

Outlook for 2020 and beyond

41

ExpectedTitelmasterformatnews flowdurch Klicken bearbeiten

We expect a significant news flow in the upcoming next 18 months

Platform

Candidate

Indication (Target)

1H-2020

2H-2020

20213

20223

FixVac

mRNA	iNeST

Intratumoral Immunotherapy

RiboMabs

RiboCytokines

		Report Phase 1
BNT111	Advanced Melanoma	Start Phase 3		Phase 2/3
Start Phase 2
BNT112	Prostate Cancer					Phase 1/2
BNT113	HPV16+ H&N Cancer		Start Phase 2
BNT114	Triple Negative Breast Cancer	Data update Phase 1
			Trial progress update1
RO7198457	1L Melanoma with CPI			Phase 2
(BNT122)	Multiple ST (basket trial)	Data update	Phase 1/2
SAR441000	Solid tumors		Report Phase 1/22
(BNT131)	(IL-12sc,IL-15sushi,GM-CSF, IFNα)
BNT141	Multiple ST		Start Phase 1
BNT142	Multiple ST (CD3+CLDN6)		Start	Phase 1
BNT151	Multiple ST(Optimized IL-2)	Start Phase 1				Phase 1
BNT152/153	Multiple Solid Tumors (IL-7,IL-2)		Start	Phase 1

Others

CAR-T Cells		BNT211	Multiple ST (CLDN6)	Start Phase 1/2			Phase 1/2
Next-Gen CP		BNT311	Multiple ST(PD-L1x4-1BB)			Report Phase 1/2
Immunomodulators		BNT312	Multiple ST (CD40x4-1BB)
Antibodies		BNT321	Pancreatic Cancer (CA19-9)
				Start Phase 1		Report	Phase 1/2
TLR7 Ligand		BNT411	Multiple ST (TLR7)
			Influenza		Start first study
Infectious and Rare
		Up to 10 Infectious Disease Indications			Start first Phase 1
Diseases
		5 Rare Disease Indications		Start first Phase 1

Legend	Expected begin of trial	Expected data readout / update	ST: solid tumors
42	1We expect this topline data update to include an update on the ongoing study, including patient enrollment numbers, with full efficacy and safety data for an interim update expected in the second half of
2021; 2As the trial is sponsored and conducted by Sanofi, the timing of data updates is not under our control, and is subject to change by Sanofi. 3Our expectations for timing of milestones beyond 2020 are

premised on and subject to the achievement of earlier milestones on their expected timelines. Press releases will be issued once first patient has been dosed.

OurTitelmasterformatgoalsdurch Klicken bearbeiten

Building a 21stCentury Immunotherapy Company

2020 Outlook
1	5 trial updates(incl. publishing BNT111 FixVac Melanoma Phase 1/2 data in peer reviewed journal)
2	Initiate Phase 3 registrational trialfor BNT111 FixVac Melanoma
3	Initiate 2 additional iNeST trialsin adjuvant stage cancers
4	Initiate Phase 1/2 trial using CARVac (BNT211)in CLDN6+ solid tumors (e.g., ovarian, testicular)
5	InitiatePhase 2 trial in HPV16+ H&N cancer
6	Continue to build global clinical development organization(US development team on East Coast)

43

An der Goldgrube 12 55131 Mainz Germany

1. [phone]

1. [phone]

1. [e-mail]

© Copyright BioNTech SE 2019. All Rights Reserved. Jan 15, 2020