Medigene : Präsentation zum Halbjahresberichts 2020

6-Months Report 2020 Conference Call

7 August 2020

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.

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Key investment highlights

Innovative T cell-based immunotherapies with broad cancer applicability

Novel DC vaccine focused on inducing T cell responses to cancer Existing partnerships & global business development opportunities

Continuous technology innovation and growing IP portfolio

Management team with complementary experience and skills

Prof. Dolores J. Schendel

CEO & CSO

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Key information

Company	Listing
Martinsried, near Munich, Germany	Frankfurt Stock Exchange (MDG1)
~140 employees	~24.6 m shares outstanding
~€39.9 m cash*	~€130 m market cap**

COVID-19 Situation Update

Outlook

Personnel

Work from home and on-site staffing, no infection to date

Partner Programs

Uninterrupted R&D activities

Clinical Trials

No delays in patient recruitment, manufacturing, regulatory

*As of 30 June 2020; **At closing 4 August 2020; HSCT: Hematopoietic stem cell transplantation

MDG1011 Phase I/II trial dose escalation readout by end Q1 2021

Ongoing MDG1021 Phase I trial in patients post allo-HSCT with relapsed hematological cancers

MAGE-A4TCR-T to enter Phase I (bluebird bio)

DC vaccine detailed data Phase I/II results in H2 2020

Publication of preclinical data at conferences

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TCR-T vs. CAR-T cells

TCR-Ts offer more target options, power, sensitivity and control

Chimeric antigen receptor (CAR)

Tumor cell

Surface proteins only

~30% of human proteome as targets

High target density per cell required for effective CAR-Ttriggering

Often toxicity against healthy cells (e.g. B cells)

T cell receptor (TCR)

Tumor cell

Both surface & intracellular proteins

100% of human proteome as targets

Very low target density per cell sufficient for effective TCR-Ttriggering

Many targets available with great

tumor cell - healthy cell discrimination

HLA-dependent recognition adds specificity

HLA: Human leukocyte antigen, molecule that presents peptides to be recognized by TCRs

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Innovation & technology differentiation

Safety & activity

Natural TCRs without mutations for higher safety

PD1-41BB switch receptor to enhance TCR-T function

Controllable TCR through on-off switch (iM-TCR)

Diversity & specificity

Multiple epitopes for one HLA

Multiple HLAs for one antigen HLA class I and class II epitopes

Epitope safety via in silico and in vitro tools

Drug product process development

Monoclonal transgenic TCR-Ts

Steppingstones to full automation and fully closed process

Proprietary and evolving GMP production process

Proprietary SIN-RV vector system

Suicide switch studied for drug product elimination

Optimization towards next-generationTCR-Ts

PD-1: Checkpoint inhibitor; 4-1BB: Activator of T cells; iM-TCR: inducible Medigene TCR; HLA: Human leukocyte antigen, molecule that presents antigens to TCRs;	6
SIN-RV:Self-inactivating retrovirus

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

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MDG1011 - Phase I/II trial design

Phase I

(+3)

(+3)

(+3)

(+3)

Up to 1x107

5x106 1x106

1x105

Single defined dose of TCR-transduced T cells/kg

Open-label,multi-center study, 3+3 dose escalation design, up to 4 cohorts

Primary endpoints: Safety at 3 months and MTD

Dose ranges from 100,000 to 10,000,000 TCR-transduced T cells per kg body weight

Single administration via i.v. infusion

DSMB review after each dose cohort

Phase II

40 treated + 40 control patients

Approx. 2 indications to be carried into Phase II

40 HLA-A*02:01 and PRAME positive patients to be treated with MDG1011 (20 per indication)

40 HLA-A*02:01 negative and PRAME positive patients serve as control groups (20 per indication)

MTD: Maximum tolerated dose; DSMB: Data safety monitoring board; https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-000440-18/DE

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MDG1021 - Phase I trial design

Dose-escalation portion

(+3)

(+3)

(+3)

3x106

1x106 0.3x106

Patients with relapsed or persistent hematogical

malignancies after allo-HSCT w/wo DLI

3+3 design with at least 9 patients

Dose 1: 0.3x106 HA-1TCR-transduced T cells per kg body weight

Dose 2: 1x106 HA-1TCR-T cells/kg

Dose 3: 3x106 HA-1TCR-T cells/kg

Assessment of safety, feasibility and preliminary efficacy

Dose-expansion portion

20 patients in an expansion group at the selected dose of MDG1021

DLI: Donor lymphocyte infusion

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MDG1021 - Treating relapse or persistence after HSCT

Remaining tumor cells

HA-1+

Patient

Allo-hematological stem cell transplantation

HA-1-

Donor

Tumor

Relapse / persistence

Vector

HA-1-specific TCR

Protective

HA-1TCR-Ts

Adoptive transfer of HA-1TCR-Ts eliminates residual tumor cells

Retrieval of donor T cells

Donor-derived

HA-1TCR-Ts

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Partnerships validate Medigene's technologies

bluebird bio

6 TCR discovery projects for defined antigen/HLA combinations

Worldwide development and commercial rights and exclusive license for IP

Clinical development of first TCR lead for MAGE-A4/HLA-A2 expected to start in 2020

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

6 TCRs

Roivant / Cytovant

Research-stage TCR specific for the target

NY-ESO-1; clinical indications chosen

DC vaccine program for AML

Discovery projects for 2 further TCRs tailored for

Asian population

Regional license rights for Greater China, South

Korea and Japan

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

DCs and 3 TCRs

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Financial review and outlook

	H1 2019	H1 2020	Guidance 2020
Total revenues	€5.6 m	€3.7 m	€7-9 m
R&D expenses	€10.9 m	€11.7 m	€24-29 m
EBITDA loss	€8.5 m	€11.3 m	€19-27 m

Liquid assets and time deposits as of 30 June 2020 amounted to ~€39.9 m

Medigene has sufficient financial resources to fund business operations until the end of 2021

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

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Key development milestones in 2020

Clinical trials

• Topline data on Phase I/II DC vaccine trial (2-years-treatment)
• H1 2020 entered Phase I clinical development of MDG1021 in post-HSCT relapsed patients

Q4 2020 complete dosing of three dose cohorts in MDG1011 Phase I dose escalation trial in AML and MDS bluebird bio to start Phase I clinical trial of MAGE-A4 TCR

Pre-clinical

• Characterization of new TCR candidates

Optimization of future TCR therapies for solid tumors

Business development

Continue pre-clinical development with bluebird bio and Roivant / Cytovant

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Contact

Dr. Gary Waanders	Dr. Anna Niedl
VP Investor Relations	Director Investor Relations
[e-mail]	[e-mail]
[phone]	[phone]

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

© Medigene AG