Medigene : AGM 2020 Management presentation

Annual General Meeting 2020 of Medigene AG

16 December 2020, virtual

Forward looking statements disclaimer

All of the information herein has been prepared by the Company solely for use in this presentation. The information contained in this presentation has not been independently verified. No representation, warranty or undertaking, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the information or the opinions contained herein. The information contained in this presentation should be considered in the context of the circumstances prevailing at that time and has not been, and will not be, updated to reflect material developments which may occur after the date of the presentation. The Company may alter, modify or otherwise change in any manner the content of this presentation, without obligation to notify any person of such revision or changes.

This presentation may contain certain forward-looking statements and forecasts which relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on the Company's business, financial condition and results of operations. The terms

"anticipates", "assumes", "believes", "can", "could", "estimates", "expects", "forecasts", "intends", "may", "might", "plans", "should", "projects", "will",

"would" or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realised. Factors that could cause these differences include, but are not limited to, implementation of the Company's strategy and its ability to further grow, risks associated with the development and/or approval of the Company's products candidates, ongoing clinical trials and expected trial results, technology changes and new products in the Company's potential market and industry, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions and legislative, regulatory and political factors. While we always intend to express our best judgment when we make statements about what we believe will occur in the future, and although we base these statements on assumptions that we believe to be reasonable when made, these forward-looking statements are not a guarantee of our performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of our control and could cause our actual results to differ materially from those we thought would occur. The forward-looking statements included in this presentation are made only as of the date hereof. We do not undertake, and specifically decline, any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments.

2

Living Immunotherapies

Immunotherapies will revolutionize the future of cancer treatment.

We harness the power of living T cells to activate the body's own defenses against cancer. By developing breakthrough therapies, we aim to significantly improve patients' lives.

This is what we are passionate about.

3

Medigene in a nutshell

Prof. Dolores J. Schendel

CEO & CSO

Clinical development of innovative cellular cancer immunotherapies

Business model

Continuous scientific progress and expansion

of the IP portfolio

Validation through partnerships

Dr. Kai Pinkernell
CDO & CMO	Headquartered in Martinsried, near Munich
Basics	~125 employees*
	~€35,8 m cash**
Axel Sven Malkomes
CFO & CBO	Frankfurt Stock Exchange (MDG1)
Listing	~24,6 m shares outstanding
	~€85 m market cap*

* As of 14 December 2020; ** As of 30 September 2020

4

Change of paradigms in cancer therapy

Activation of the immune system

Since 2010

	1990 - 2010
Tumor			Immunotherapies
treatment		Advanced approaches	Stem cell transplantation
		Cancer vaccines
		Hormone therapy
		Adoptive cell therapy
Pre 1990		Small Molecules
Classical therapies
	Antibody Therapies

Surgery

Radiation

Chemotherapy

6

Immune cells in our blood

Blood cells

Erythrocytes	Leukocytes	Monocytes

Thrombocytes

T cells

Granulocytes	Lymphocytes
Granulocytes	Granulocytes

Schematic depiction

7

Medigene's antigen and epitope selection platform

Addressing diversity

HLA types

Antigen Targets

Expression levels

Cells

Tumors

Healthy tissues

Epitopes

Processing and presentation

Activation of T cells

Mass spectrometry	Immunogenicity
screening
Engineered reporter cell lines / 'dark' TSAs	Target specific activation of T cells

HLA-A*XXHLA-B*XXHLA-C*XX

Clinically relevant epitopes

Multiple epitopes for one HLA-type

Multiple HLAs per antigen

• Maximized commercial opportunity with simple combinations

8

Efficient TCR discovery - At scale and at speed

Antigen selection

Multiple healthy donors used for primings with DC-T cell co-cultures

Expansion of single

T cell clones

Functional

selection

TCR leads

High throughput automation

Highest level of standardization and reproducibility:

Automatic well screening

Tens of thousands of screened clones

Thousands of specific T cell clones characterized

Fast isolation of high avidity TCRs

Natural TCRs without mutations for higher safety

TCRs for all HLA-A,-B and -C alleles

Tens of thousands of clones screened

Thousands of clones characterized

Tens of clones fully characterized and sequenced

9

Expression of PD1-41BB in TCR-Ts leads to improved repetitive killing capacity

Orange: tumor cells

Halo: TCR-T cells

• TCR-Tcells expressing PD1-41BB - improved killing of PD-L1-positive tumor cells.
• PD1-41BBovercomes the inhibitory signal delivered via the PD-1/PD-L1 checkpoint pathway.

Images of TCR-T cells expressing PD1-41BB_TCR I or TCR I only in co-culture with PRAME-positive and PD-L1-positive tumor cells (red-labelled) recorded at the indicated time points. Tumor cell killing	10
mediated by TCR-T cells is evident by the reduction of red-labelled cells. The arrows indicate addition of a new tumor cell spheroid simulating repeated exposure of TCR-T cells to tumor cells.

Growing immunotherapy pipeline

TCR-T

Project	Target	Preclinical	Phase I	Phase II	Partner

MDG1011	AML, MDS
(PRAME)
MDG1021	Post-HSCT relapse
(HA-1)
MDG10XX	Solid tumors
(undisclosed)
bluebird bio	Undisclosed
(MAGE-A4)
	Synovial sarcoma,
Cytovant
MM, solid tumors
(CVT-TCR-01)
(NY-ESO-1)

DC

DC vaccine

AML

(WT-1 / PRAME)

Cytovant

AML

(CVT-DC-01)

(WT-1 / PRAME)

PRAME, HA-1,MAGE-A4,NY-ESO-1, WT1: Tumor antigens;

Completed;

Ongoing;

In preparation

12

MDG1011 - TCR-Ts fighting blood cancer

Target antigen:

PRAME (Preferentially Expressed Antigen in Melanoma)

PRAME is a well-characterized tumor antigen, which is expressed in many hematological and solid tumor indications

The study:

Combined Phase I/II Study evaluating safety, feasibility and early signs of efficacy

Indications for the Phase I part:

Acute myeloid leukemia (AML)

Myelodysplastic Syndrome (MDS)

Dosing of the 3rd dose cohort of the Phase I part expected in Q1 2021

Evaluation of partnerships for Phase II part

ASH poster, 6 December 2020

Other

Phase I

≥1 AML/MDS

(+3)

(+3)

(+3)

(+3)

Up to 1x107

5x106 1x106

1x105

Single defined dose of TCR-T cells/kg

13

MDG1021 - The second clinical TCR-T candidate

HA-1-specific TCR inlicensed from Leiden University Medical Center (LUMC) at the end of 2018

HA-1 belongs to a group of so-called 'minor histocompatibility antigens'

The approach allows the elimination of the patient's hematopoietic system, where leukemia and lymphoma cells are found

Safety and Feasibility already tested clinically in a Phase I trial in 5 patients

Phase I trial for the treatment of relapse after hematopoietic stem cell transplantation initiated in July 2020 at the LUMC

Dose-escalation portion

Dose-expansion portion

(+3)

(+3)

(+3)

3x106

1x106 0.3x106

3+3 study design per dose cohort

20 patients at the selected dose of MDG1021

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DC vaccine - Phase I/II trial in AML completed

20 patients suffering from acute myeloid leukemia receiving DC vaccine against Wilms Tumor-1(WT-1) and PRAME antigens for 2 years

Primary objectives: Safety and feasibility

Secondary objectives: Overall survival (OS), progression free survival (PFS), control of minimal residual disease (MRD), time to progression (TTP), induction of immune responses

Treatment protocol:

Dec. 2018:	Jan. 2019:
1-year interim	2-year final
analysis	analysis

15

DC vaccine - Phase I/II trial in AML completed

Very good safety and tolerability

Very good feasibility of manufacturing the vaccine from monocytes of heavily chemotherapy-pretreated patients

Topline results

No serious adverse events

80% overall survival (even when differentiated by age groups below and above 60 years)

55% progression-free survival (60% in those under and 50% in those over 60 years of age)

Development is continued by Roivant/Cytovant in Asia

Medigene is evaluating further partnerships in other regions

Deceased

Deceased

Surviving

						Surviving
y
		y
				Relapse

Relapse

y

y

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Global Partnerships

bluebird bio

World-wide license for up to 6 TCR projects

First TCR in preparation for clinical trial

MDG eligible for R&D funding, development, regulatory and sales milestones and tiered, up to double digit % royalties

Roivant/Cytovant

License partnership in Greater China, South Korea and Japan for NY-ESO-1 TCR and 2 further TCRs; Continuation of the DC vaccine program

MDG eligible for R&D funding, development, regulatory and sales milestones and tiered, up to double digit % royalties

Medigene develops TCRs against target antigens, which are defined by our partners

TCRs are delivered to our partners, they are responsible for further development

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Annual financial statement 2019 (1)

Balance sheet item	2018	2019	Change
	[€ m]	[€ m]
Assets
Non-current assets	67,4	51,5	-24%
Current assets	57,5	57,7	0%
Total	124,9	109,2	-13%
thereof cash and cash
equivalents and time	71,4	54,7	-23%
deposits
Shareholders' equity and liabilities
Shareholders' equity	103,2	81,8	-21%
Current liabilities	8,8	10,2	16%
non-current liabilities	12,8	17,2	34%
Total	124,9	109,2	-13%

Equity ratio of 75% (2018: 83%)

Decrease in cash and cash equivalents and time deposits due to intensification of preclinical and clinical activities

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Annual financial statement 2019 (2)

Item	2018	2019	Change	Guidance 2019	Explanation
	[€ m]	[€ m]		[€ m]
					Increase of total revenue due to
Total revenues	7,8	10,6	37%	10-11	partnerships with bluebird bio and,
					since April 2019, Roivant/Cytovant
					Increase of R&D expenses due to
R&D expenses	17,1	22,6	32%	24-29	intensification of preclinical and
					clinical activities
EBITDA loss	20,9*	17,8	-15%	17-18	Results from the aforementioned
items

*FREP assessment

In relation with the sale of Veregen®, which took place in April 2019, the inventories of the active pharmaceutical ingredient were revalued by EUR 4.7 million in the "Inventories"

The cash neutral loss which was previously taken into account in 2019 was being accounted for retroactively in the fiscal year 2018 after receiving the assessment result

Adaption of EBITDA loss from €16,3 m to €20,9 m

20

Financial outlook (Quarterly Statement Q3 2020)

	Guidance 2020
	[€ m]
Total revenues	7-9
R&D expenses	22-26
EBITDA loss	17-24

Cash and cash equivalents as of 30 September 2020 amounted to ~€35.8 m

No milestone payments or cash inflows are included from existing or future partnerships or transactions

Based on current planning and the internal re-priorization of projects, Medigene has sufficient financial resources to fund business operations into Q3 2022

21

Capitals

Utilization of capital in 2019

No utilization of Authorized Capital

Partial utilization of Contingent Capital XXIII by issuing new shares to service converted stock options

Issue of 5.521 shares

Utilization of capital in 2020 (as of 16 December 2020)

No utilization of Authorized Capital

No utilization of Contingent Capital

TOP 6: New Authorized Capital 2020/I of approx. 40% of the nominal capital (9,825,000 shares)

Self-restriction to a maximum of 20% of the nominal capital with exclusion of subscription rights

Please refer to the AGM invitation for the report pursuant to Section 203 (2) Sentence 2 and Section 186 (4) Sentence 2 of the German Stock Corporation Act (AktG)

TOP 7: New Contingent Capital 2020/I of approx. 40% of the nominal capital (9,825,000 shares)

Self-restriction to a maximum of 20% of the nominal capital with exclusion of subscription rights

Please refer to the AGM invitation for the report pursuant to Section 186 (4) Sentence 2 and Section 221 (4) of the German Stock Corporation Act (AktG)

22

What happened so far…

				Initiation of
Founding		Strategic	DC vaccine
	realignment		trial
1994	2000	2014	2015	2016	2017

bluebird bio

IPOTake-over ofDeal (1) Trianta

Immunotherapies

	PD1-41BB		Initiation of
	Switch Receptor	MDG1021 trial
	Completion of
Initiation of	DC vaccine
MDG1011 trial		trial
2018	2019	2020	2021

bluebird bio	Roivant/	IRICoR
Deal (2)	Cytovant	Deal
	Deal

• Realignment to immunotherapies with focus on solid tumors

24

Share price development since beginning of 2019

	12,00																																																		1000
	10,00
	800
Share price
XETRA [€]	8,00
600
	6,00
	400
	4,00
	200
	2,00
																																																			Volume
																																																				XETRA
	0,00																																																		0	[# k]

25

Value added at Medigene from 2014 to date

Cornerstones of the DC platform	Cornerstones of the TCR-T platform
Antigen identification for diverse DC vaccines	Analysis of numerous antigens
CMC/GMP process development for DC	Screening expended from 20 to 600 cell culture
vaccine production	plates per experiment
Completed Phase I/II study in acute myeloid	Number of T cells needed for sequencing
leukemia (AML)	reducet to absolute minimum
	CMC/GMP process development perfected up
	to clinical trial authorizations

• Initiation of 2 own TCR-T clinical trials
• Partnerships with bluebird bio and Roivant/Cytovant
• Continuously growing IP portfolio (32 new patents from 27 patent families, 66 patents pending)

26

…and how we will continue

Clinical trials

Dosing of the 3rd dose cohort of Phase I part of MDG1011 clinical trial in blood cancer expected in Q1 2021, partnering of Phase II part contingent on results

Continuation of the Phase I trial of MDG1021 in patients with blood cancer suffering from a relaps after hematopoietic stem cell transplantation

bluebird bio: Potential initiation of Phase I trial of MAGE-A4 TCR

Roivant/Cytovant: Potential initiation of Phase II trial of DC vaccine

Preclinical research

Characterization of new TCR candidates

Optimization of future TCR-T therapies for use in solid tumor indications

Partnerships

Continuation of preclinical development together with bluebird bio and Roivant/Cytovant

Evaluation of new partnerships

27

Agenda of the Annual General Meeting

1

2

3

4

5

6

7

8

9

Presentation of the approved financial statements 2019

Discharge of the Executive Management Board members from their responsibilities for financial year 2019

Discharge of the Supervisory Board members from their responsibilities for financial year 2019

Election of Company auditors for financial year 2020

Remuneration system of the members of the Supervisory Board of Medigene AG

Resolution to revoke Authorized Capital 2018/I and create new Authorized Capital 2020/I with the option to exclude subscription rights

Resolution to revoke Contingent Capital 2018/II as well as on authorization of the Executive Management Board to issue convertible bonds or bonds with warrants 2020 and on creation of new Contingent Capital 2020/I

Decrease in the number of Supervisory Board members

Election to the Supervisory Board

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Thank you

Prof. Dolores J. Schendel	Axel Sven Malkomes	Dr. Kai Pinkernell
CEO & CSO	CFO & CBO	CDO & CMO

Medigene AG	T [phone]
Lochhamer Str. 11	F [phone]
82152 Planegg / Martinsried	[e-mail]
Germany	www.medigene.com

© Medigene AG