BioNTech : Corporate Presentation

Corporate Presentation

May 2024

This Slide Presentation Includes Forward-Looking Statements

This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech's expected revenues and net profit/(loss) related to sales of BioNTech's COVID-19 vaccine, referred to as COMIRNATY where approved for use under full or conditional marketing authorization, in territories controlled by BioNTech's collaboration partners, particularly for those figures that are derived from preliminary estimates provided by BioNTech's partners; the rate and degree of market acceptance of BioNTech's COVID-19 vaccine and, if approved, BioNTech's investigational medicines; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment and expected regulatory recommendations to adapt vaccines to address new variants or sublineages; the initiation, timing, progress, results, and cost of BioNTech's research and development programs, including BioNTech's current and future preclinical studies and clinical trials, including statements regarding the timing of initiation, enrollment, and completion of studies or trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations; the targeted timing and number of additional potentially registrational trials, and the registrational potential of any trial BioNTech may initiate; discussions with regulatory agencies; BioNTech's expectations with respect to intellectual property; the impact of BioNTech's acquisition of InstaDeep Ltd. and its collaboration and licensing agreements; the development, nature and feasibility of sustainable vaccine production and supply solutions; and BioNTech's estimates of revenues, research and development expenses, selling, general and administrative expenses, and capital expenditures for operating activities. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

The forward-looking statements in this presentation are based on BioNTech's current expectations and beliefs of future events, and are neither promises nor guarantees. You should not place undue reliance on these forward- looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech's control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; BioNTech's pricing and coverage negotiations regarding its COVID-19 vaccine with governmental authorities, private health insurers and other third-party payors; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; competition from other COVID-19 vaccines or related to BioNTech's other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the timing of and BioNTech's ability to obtain and maintain regulatory approval for its product candidates; the ability of BioNTech's COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech's and its counterparties' ability to manage and source necessary energy resources; BioNTech's ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech's third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; the impact of COVID-19 on BioNTech's development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech's and its collaborators' ability to commercialize and market BioNTech's COVID-19 vaccine and, if approved, its product candidates; BioNTech's ability to manage its development and expansion; regulatory developments in the United States and other countries; BioNTech's ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time. You should review the risks and uncertainties described under the heading "Risk Factors" in BioNTech's Report on Form 6-K for the period ended March 31, 2024 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC's website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this presentation in the event of new information, future developments or otherwise.

Furthermore, certain statements contained in this presentation relate to or are based on studies, publications, surveys and other data obtained from third-party sources and BioNTech's own internal estimates and research. While BioNTech believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, any market data included in this presentation involves assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. While BioNTech believes its own internal research is reliable, such research has not been verified by any independent source. In addition, BioNTech is the owner of various trademarks, trade names and service marks that may appear in this presentation. Certain other trademarks, trade names and service marks appearing in this presentation are the property of third parties. Solely for convenience, the trademarks and trade names in this presentation may be referred to without the ® and TM symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

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A Global Immunotherapy Leader

COVID-19 VACCINE GLOBAL LEADERSHIP1

	Comirnaty		Doses distributed		Potential introduction of combination
	2		respiratory vaccines in late 2025 or 2026,
>50 % Market Share	>460 m in 2023
		if approved2

STRONG FINANCIAL POSITION

€ 16.9 bn

total cash plus security investments3

MULTIPLATFORM ONCOLOGY PORTFOLIO

21 Clinical programs across

11 Technology Platforms

EXPANDING INFECTIOUS DISEASE PIPELINE

7 Clinical programs in high unmet need indications

Growing proprietary pipeline

Partnership with Pfizer in respiratory and other high need indications

BROAD COLLABORATION NETWORK

LEADER IN ARTIFICIAL

Aim for 10+ potentially registrational trials ongoing by year end 2024

Yearly oncology launches planned from 2026 onwards2

INTELLIGENCE

Building a multi-product global biotechnology company to address the world's ​most pressing health challenges with

pioneering technologies delivered at scale

1. Partnered with Pfizer; 2. Subject to successful clinical development and regulatory approval; 3. Consists of cash and cash equivalents of €8,976.6 million and security investments of €7,962.7 million, as of March 31, 2024.

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Our Vision: Harnessing the Power of the Immune System to Fight Human Disease

Elevating success beyond our historical achievement

	Innovative precision	Multi-product
	medicine pipeline
Sustainable respiratory	targeting multiple	immunotherapy pioneer
vaccine business	product approvals in	addressing medical need
	oncology in the coming	worldwide
	years

BioNTech's key objectives for the next phase

Powered by breakthrough science, disruptive technologies & AI

AI = artificial intelligence.

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Our Multi-PlatformImmuno-Oncology Pipeline Today

	Phase 1		Phase 1/2		Phase 2		Phase 3

BNT116

Adv. NSCLC

Autogene cevumeran (BNT122)1 Multiple solid tumors

BNT152 + BNT153 (IL-7, IL-2)Multiple solid tumors

BNT221

Refractory metastatic melanoma

BNT321 (sLea)

Metastatic PDAC

BNT322/GEN10563

Multiple solid tumors

BNT326/YL2026 (HER3)

Multiple solid tumors

BNT142 (CD3xCLDN6)

Multiple CLDN6-pos. adv. solid tumors

BNT151 (IL-2 variant)

Multiple solid tumors

BNT211 (CLDN6)

Multiple solid tumors

BNT311/GEN10463 (acasunlimab; PD-L1x4-1BB) Multiple solid tumors

BNT312/GEN10423 * (CD40x4-1BB)

Multiple solid tumors

BNT313/GEN10533 (CD27)

Multiple solid tumors

BNT314/GEN10593 (EpCAMx4-1BB)

Multiple solid tumors

BNT316/ONC-392 (gotistobart)4 (CTLA-4)mCRPC, + radiotherapy

BNT316/ONC-392 (gotistobart)4 (CTLA-4)Multiple solid tumors

BNT321 (sLea)

adjuvant PDAC, +mFOLFIRINOX

BNT323/DB-13035 (HER2)

Multiple solid tumors

BNT324/DB-13115 (B7H3)

Multiple solid tumors

BNT325/DB-13055 (TROP2)

Multiple solid tumors

BNT411 (TLR7)

Multiple solid tumors

BNT1112

aPD(L)1-R/R melanoma, + cemiplimab

BNT113

1L rel./met. HPV16+ PDL-1+ head and neck cancer, + pembrolizumab

BNT1162

1L adv. PD-L1≥ 50% NSCLC, + cemiplimab

Autogene cevumeran (BNT122)1

1L adv. melanoma, + pembrolizumab

Autogene cevumeran (BNT122)1

Adj. ctDNA+ stage II or III CRC

Autogene cevumeran (BNT122)1

Adj. PDAC, + atezolizumab + mFOLFIRINOX

BNT311/GEN10463 (acasunlimab; PD-L1x4-1BB) R/R met. NSCLC, +/- pembrolizumab

BNT316/ONC-392 (gotistobart)4 (CTLA-4) Plat.-R.ovarian cancer, + pembrolizumab

BNT316/ONC-392 (gotistobart)4 (CTLA-4) anti-PD-1/PD-L1experienced NSCLC

BNT323/DB-13035 (HER2)

HR+/HER2-low met. breast cancer

BNT323/DB-13035 (HER2)PLANNED

HER2-expressing rec. endometrial cancer

Legend

mRNA

Cell therapy

Next generation IO

ADCs

Small molecules

1. Partnered with Genentech, member of Roche Group; 2. Partnered with Regeneron; 3. Partnered with Genmab; 4. Partnered with OncoC4; 5. Partnered with DualityBio; 6. Partnered with MediLink Therapeutics. *Two phase 1/2 clinical trials in patients with solid tumors are ongoing in combination with immune checkpoint inhibitor +/- chemotherapy

NSCLC = non-small cell lung cancer; SCLC = small cell lung cancer; mCRPC = metastatic castration resistant prostate cancer; HPV = human papillomavirus; PDAC = pancreatic ductal adenocarcinoma; CRC = colorectal cancer; CLDN = claudin; IL = interleukin; 1L = first line; R/R = relapsed/refractory; HER2/HER3 = human epidermal growth factor 2/3; sLeA = sialyl-Lewis A antigen; TROP2 = trophoblast cell-surface antigen 2; TNBC = triple negative breast cancer.

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Our Oncology Approach

Goals

Address the continuum of cancer

Bring novel therapies to cancer patients and establish new treatment paradigms

Open up novel options to combine platforms and therapies

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Strategy

Portfolio covering compound classes with synergistic mechanisms of action

• Immunomodulators
• Targeted therapies
• Individualized and off-the-shelf mRNA vaccines

Programs across a wide range of solid tumors and stages of treatment

Programs with first-in-class and / or best-in-class potential

Unique therapeutic combinations

Towards a Potentially Curative Approach to Cancer: Differentiated Combinations

Immunomodulators

Novel checkpoint inhibitors, cytokines, immune agonists

Immunomodulators

• Focus on the most relevant and crucial IO pathways
• Targeting different complementary players in the complex cancer immunity cycle may promote a thorough and durable anti-tumor effect

Targeted therapy

• Potent and precise therapies could rapidly reduce tumor burden
• Designed to have clinical efficacy across the entire disease continuum including late lines

SynergySynergy

Space for potentially curative

Targeted	approaches	mRNA
therapy	Synergy	vaccines
ADCs, CAR-T,
TCR-T, small
molecules

mRNA cancer vaccines

• Could eliminate polyclonal residual disease with individualized vaccines for potential long-term impact
• Polyspecific activity by targeting multiple antigens at once

ADC = antibody-drug conjugate; CAR = chimeric antigen receptor; TCR-T = T-cell receptor engineered T cell; IO = immune oncology.

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BioNTech - Full Exploration of Cancer Vaccine Target Space

Neo- Individualized

antigens therapy

iNeST1

individualized

Neoantigen-Specific immunoTherapy

mRNA- Lipoplex platform

Fixed Antigen

Vaccine

FixVac

Multiple Off-the-shelf

shared therapy antigens

Artificial

Individual

intelligence-

Individualized

driven

patient samples

immuno-

neoantigen

(blood and tissue)

therapy

prediction

Mapping of	On-demand
mutations	tailored RNA
	manufacturing

ANTIGEN 1
ANTIGEN 2
ANTIGEN 3
ANTIGEN 4	Multi-antigen
Fixed combination of
approach tailored
shared tumor antigens2	to each indication

Strong vaccine- induced ex vivo CD8+

1. cell responses across different cancer types3

10.3%

Mutant Neoantigen

TNBC, BNT114

TNBC-MERIT trial

MAGE-A3	NY-ESO-1
Melanoma, BNT111,	Melanoma , BNT111,
Lipo-MERIT trial	Lipo-MERIT trial
2.1%	10.1%

5%

HPV16-E7

Head & Neck Cancer

BNT113, HARE40 trial

1. iNeST, or autogene cevumeran (BNT122), is being developed in collaboration with Genentech, a member of the Roche Group. 2. Amount of tumor antigens varies across programs; 3. T cell responses analyzed by ex vivo multimer staining analysis in blood.

TNBC = triple-negative breast cancer; MAGE = melanoma-associated antigen; NY-ESO-1 = New York esophageal squamous cell carcinoma-1; HPV = human papillomavirus E7.

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Growing Portfolio of Cancer Vaccine Candidates Across Multiple Solid Tumors

Six ongoing Phase 2 trials with cancer vaccine candidates in multiple disease settings

	Individualized vaccine: iNeST1			FixVac
Adjuvant	1L	R/R	R/R	Post-adj.	Neo-adj, mCR	1L	Multiple settings
CRC		PDAC	Melanoma	Solid Tumors	Melanoma	TNBC	Prostate Cancer	HPV16+ HNSCC	NSCLC
Phase 2		Phase 2	Phase 2	Phase 1	Phase 2	Phase 1	Phase 1/2	Phase 2	Phase 1 & 2
Autogene		Autogene	Autogene	Autogene	BNT111	BNT114	BNT112	BNT113 +	BNT116
cevumeran		cevumeran	cevumeran	cevumeran	+/- Cemiplimab		Monotherapy &	Pembrolizumab	Monotherapy &
(BNT122)		(BNT122)	(BNT122)	(BNT122)
			+ Cemiplimab	vs.	Cemiplimab
Monotherapy		+ Atezolizumab	+ Pembrolizumab	+ Atezolizumab
			+ ADT	Pembrolizumab	or CTx
Study ongoing		Study ongoing	Enrollment	Enrollment	Enrollment	Study completed	Discontinued	Study ongoing	Ph 1 study in
		Data presented	completed,	completed,	completed,	Data presented at	Data presented	Data presented at	multiple settings
		study is ongoing	study is ongoing	study is ongoing	ongoing
		from investigator-	SITC 2020	at SITC 2021	ESMO-IO 2022
		initiated Ph 1 study	Analysis of PFS as	Data presented at	Data presented	Manuscript in			Data presented at
		at ASCO 2022 &	primary endpoint	AACR 2020	from Ph1 at SITC			SITC 2023 and
		preparation
		AACR 2024 and	will be based on	Manuscript	2021 and published			AACR 2024
		published (Rojas	events and define	(Sahin et al., Nature
		in preparation				Ph 2 study in 1L
		et al. Nature.2023)	when we will report	2020)
						NSCLC ongoing2
			results

1. Partnered with Genentech, member of Roche Group; 2. Sponsored by Regeneron.

iNeST = individualized Neoantigen Specific Immunotherapy;1L = first line; R/R = relapsed/refractory; CRC = colorectal cancer; PDAC = pancreatic ductal adenocarcinoma; TNBC = triple-negative breast cancer; HPV = human papillomavirus; HNSCC = head and neck squamous carcinoma; NSCLC = non-small cell lung cancer; ADT = androgen deprivation therapy; CTx = chemotherapy; PFS = progression-free survival; ASCO = American Society of Clinical Oncology; AACR = American Association for Cancer Research; SITC = Society for Immunotherapy of Cancer; ESMO-IO = European Society for Medical Oncology Immuno-Oncology.

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Therapeutic IO Candidates with Novel Modes of Action Across Multiple Solid Tumors

BNT316/	BNT311/	BNT312/	BNT313/	BNT314/	BNT315/
ONC-3922	GEN10461
GEN10421	GEN10531	GEN10591	GEN10551
(gotistobart)	(acasunlimab)
Anti-CTLA4	Anti-PD-L1Anti-4-1BB	Anti CD40 Anti-4-1BB	Anti-CD27	Anti-EpCAMAnti-4-1BB	Anti-OX40

BNT327/ PM80023

Anti-VEGF

Optimized Fc		Inert Fc		Inert Fc		Inert Fc
Clinical status	Clinical status	Clinical status	Clinical status
• Ph1/2 in multiple	• Ph1/2 in multiple	• Ph1/2 trials in	• Ph1/2 in multiple
solid tumors	solid tumors	multiple	solid tumors
• Ph2 in PROC	• Ph2 in mNSCLC	solid tumors

• Ph3 in 2L+ mNSCLC

	Inert Fc		Inert Fc
Clinical status	Clinical status
• IND approved	• IND approved
• FPD achieved in FIH	• FIH planned
in Q1 2024

Inert Fc

Anti-PD-L1 VHH

Clinical status

• Several Ph2/3 in patients in China ongoing
• Investigational New Drug Application accepted for further studies in the U.S.

Additional trial starts and data readouts planned in 2024

1. Partnered with Genmab; 2. Partnered with OncoC4; 3. Partnered with Biotheus. CTLA4 = Cytotoxic T-Lymphocyte-Associated Protein 4; CD27, CD40, 4-1BB = members of the tumor necrosis factor receptor superfamily; PDL-1 =Programmed cell death ligand 1; HER2 = human epidermal growth factor receptor 2; ADCC = Antibody dependent cell-mediated cytotoxicity; ADCP = Antibody dependent cellular phagocytosis; PROC = platinum-resistant ovarian cancer; NSCLC = non-small cell lung cancer; EC = endometrial cancer APC = antigen presenting cells; VEGF = vascular endothelial growth factor; TME = tumor microenvironment; CTx = chemotherapy; IND = investigational new drug application; FIH = first in human.

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