H1 2017 RESULTS - MOLOGEN AG · h1 2017 results dr mariola soehngen – ceo walter miller - cfo...

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H1 2017 RESULTS DR MARIOLA SOEHNGEN – CEO WALTER MILLER - CFO BERLIN, 10 AUGUST 2017 www.mologen.com

Transcript of H1 2017 RESULTS - MOLOGEN AG · h1 2017 results dr mariola soehngen – ceo walter miller - cfo...

Page 1: H1 2017 RESULTS - MOLOGEN AG · h1 2017 results dr mariola soehngen – ceo walter miller - cfo berlin, 10 august 2017 1

H1 2017 RESULTS DR MARIOLA SOEHNGEN – CEO WALTER MILLER - CFO

BERLIN, 10 AUGUST 2017

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www.mologen.com

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Disclaimer

Certain statements in this presentation contain formulations or terms referring to the future or future developments, as well as negations of such formulations or terms, or similar terminology. These are described as forward-looking statements. In addition, all information in this presentation regarding planned or future results of

business segments, financial classification numbers, developments of the financial situation, or other financial or statistical data contains such forward-looking statements. The company cautions prospective investors not to rely on such forward-looking statements as certain prognoses of actual future events and developments. The company is neither responsible nor liable for these forward-looking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication.

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Agenda

Business Overview and Update on Operations 4

Key Financials and Outlook 13

Appendix 19

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Highlights H1 2017 and Onwards

Operations:

lefitolimod

Financials

Full placement of a convertible bond of €4.99 million: 01/17

Study progress and intensified business development activities resulted in

higher R&D expenses; EBIT declined accordingly

Study program has made good progress:

Top-line results of the TEACH study presented: 08/17

Grant to collaboration partner Aarhus University for combination study in

HIV with lefitolimod

Top-line results of the exploratory IMPULSE study presented: 04/17

Completion of patient recruitment for pivotal study IMPALA: 05/17

Posit. data from preclinical combo studies: lefitolimod & EnanDIM® with CPIs

Strategy “Next Level”: ongoing implementation of measures

Outsourcing production; accelerated partnering/out-licensing discussions

Executive Board New CMO, Dr Matthias Baumann, on board

Legend: CPIs checkpoint inhibitors

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Advanced Immunotherapy Pipeline:

Late-Stage Lefitolimod & Follow-Up EnanDIM®

Indication(1) PC Ph I Ph II Ph III Timeline(2) Exclusivity(3)

Metastatic colorectal

cancer (mCRC)

LPI: 05/17

Data: ’19

Filing: ’19/’20

EU: 2030

US: 2028

Small-cell lung cancer

(SCLC)

04/17: top-line

results

EU: 2030

US: 2028

Advanced solid

malignancies

(+ ipilimumab)

LPI: ‘18

Data: ’19

EU: 2036

US: 2036

Human immunodeficiency

virus (HIV)

08/17: results of

extension phase

EU: 2036

US: 2036

Cancer/

infect. diseases

Pre-clinical

EU: 2035

US: 2035

Renal cell carcinoma

(RCC)

Ph I / II data

available

backup compound

EU: 2036

orphan drug status

US: 2038

Le

fito

lim

od

E

na

nD

IM®

M

GN

1601

Notes: (1) Pipeline overview excludes MIDGE platform | (2) Timeline Denotes latest estimated timeline of upcoming milestones |

(3) Exclusivity Denotes estimated minimum market exclusivity horizon based on patent and data protection Legend: PC Pre-clinical |Ph Phase | LPI last patient in

IMPALA (MGN)

IMPULSE (MGN)

TEACH (Aarhus)

MD Anderson

ASET (MGN)

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TEACH Trial: Study Design

TEACH (Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV infection):

non-randomized interventional phase Ib/IIa trial to evaluate lefitolimod in HIV positive

patients under antiretroviral therapy (ART):

• Initial phase: 15 patients under ART received four weeks of lefitolimod therapy

(60 mg s.c. twice weekly)

• Extension phase: 12 patients under ART received 24 weeks of lefitolimod therapy

(60 mg s.c. twice weekly):

After completion, nine of these patients participated in an analytical antiretroviral

treatment interruption (ATI) until viral rebound

ATI is an established procedure used to determine the size and reduction of the

reservoir of latent infected cells which is measured as time to viral rebound. After

viral rebound ART is reintroduced.

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TEACH: Study Design Initial and Extension Phase

ART Antiretroviral Therapy | ATI Analytic Treatment Interruption

ART

ART ATI

Initial Phase TEACH

Imm

unolo

gic

al

Readout

AR

T p

lus

4 w

eeks le

fitolim

od

Scre

enin

g

ATI

Extension Phase TEACH 4

w.

lefito

limo

d

ART plus

24 weeks lefitolimod

Scre

enin

g

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TEACH EXTENSION PHASE: Results

• Sustained increases in activation of important immune cells (CD4 and CD8 T cells) were observed

throughout the dosing period of 24 weeks.

• Lefitolimod triggered maturation of other important immune cells (B cells) towards antibody-producing

cells.

• After interruption of ART, one of the nine patients who participated in that study part showed viral

control for more than 20 weeks, whereas the interval until viral rebound is generally two weeks.

• The intervention had no detectable effects on the size of viral reservoir in peripheral blood in the total

study population of 12 patients, which was defined as the primary endpoint of the extension phase of

the study.

• 24 weeks of lefitolimod treatment was safe and well tolerated in HIV patients on ART, corroborating the

favourable safety profile already seen in cancer patients.The most common related adverse events

study population were: neutropenia, injection site reaction, fatigue, dizziness, and headache. The

majority of adverse events were of mild or moderate intensity with no life-threatening or fatal events.

There were no discontinuations due to adverse events and no related serious adverse events.

Although lefitolimod alone on top of ART did not show the desired effect on the viral

reservoir, lefitolimod could be an important combination partner for other interventions

aiming at HIV cure, such as monoclonal antibodies or vaccines

Results provide significant guidance for…..

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TEACH: Next Steps

• A more extensive evaluation of the TEACH data is currently ongoing including

further immune and HIV reservoir parameters

• Detailed TEACH study results of the extension phase will be presented at an

international scientific conference

• A combination trial with lefitolimod and other promising HIV cure interventions

has recently been funded and is expected to start in 2018 as a collaboration

between MOLOGEN, Aarhus University Hospital and other international

partners

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Grant by Gilead for Combination Study in

HIV with Lefitolimod

Aarhus University Hospital received 2.75 US$ from Gilead to fund clinical

study in HIV-positive patients on antiretroviral treatment (ART)

Evaluating combination of lefitolimod with novel virus-neutralizing

antibodies

Rationale for the study

Coordinated mode of action of the compounds could generate a more

effective eradication of the HIV reservoir compared to standard HIV

treatment regimens, i.e. ART

Promising potential for the combination of lefitolimod with virus-neutralizing

antibodies

New use of “kick & kill” concept with virus-neutralizing antibodies

Legend: ART antiretroviral therapy

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IMPULSE: Positive Results in Two Subgroups of Patients

Treated with lefitolimod

IMPULSE: Exploratory phase II controlled, two-arm, multinational trial with 102 patients with extensive

disease small cell lung cancer (SCLC) to evaluate efficacy and safety of lefitolimod in comparison to

control group (standard therapy)

• Primary endpoint “overall survival” (OS) not met in the overall study population in this challenging

indication

• Positive results in two pre-defined and clinically relevant subgroups of patients: Notably, an

overall survival (OS) benefit was shown in comparison to the control arm (local standard of care):

1. Patients with a low count of activated B cells, an important immune parameter:

Hazard ratio “HR”: 0.59; 95% confidence interval “CI”: 0.29–1.21

2. Patients with reported Chronic Obstructive Pulmonary Disease (COPD), a frequent

underlying disease:

Hazard ratio “HR”: 0.54; 95% confidence interval “CI”: 0.21–1.38

Results provide significant guidance for defining patient populations most likely to

benefit from lefitolimod

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Break-Through Potential for Combinations of

Lefitolimod with Checkpoint Inhibitors (CPI)

First preclinical confirmation of the combination approach of lefitolimod with

checkpoint inhibitors in treatment of cancer

The mode of action of lefitolimod is ideally suited to enhance the anti-tumor

effect of checkpoint inhibitors

This was confirmed in mouse tumor models where lefitolimod clearly

improved the anti-tumor effect of checkpoint inhibitors anti-PD-1 and anti-

PD-L1:

Combination of lefitolimod and anti-PD-1 was superior to each

monotherapeutic approach which was also in line with ‘in vitro’

experiments

The combination of lefitolimod with anti-PD-L1 further reduced tumor

growth compared to either lefitolimod or anti-PD-L1 monotherapy and

thus prolonged survival

Promising potential for the combination of lefitolimod with checkpoint

inhibitors

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Key Financials Q2/H1 2017

• R&D mainly driven by study progress

• Issuance of convertible bonds reflected in CF from financing activities in H1 2017

In € million Q2 2017 Q2 2016 ∆ H1 2017 H1 2016 ∆

R&D expenses 4.1 3.4 21% 8.0 7.1 13%

EBIT -5.4 -5.3 2% -10.5 -9.8 7%

CF from operating activities -5.2 -4.8 8% -11.2 -9.2 22%

CF from financing activities -0.1 0.0 - 4.8 0.0 -

Monthly cash burn 1.8 1.6 13% 1.9 1.5 27%

In € million 30 June

2017

31 Dec

2016 ∆

Total assets 15.1 21.4 -29%

Cash & cash equivalents 14.2 20.5 -31%

Equity 1.8 11.8 -85%

Equity ratio 12% 55% -78%

Legend: CF Cash flows

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Refinancing -

Current Shareholder Structure

Capital Measure 2017

Cash reach until early 2018 according to current planning

Shareholder Structure as at June 2017 (estimates)

<25%

5% 4%

4%

62%

Global Derivative Trading GmbH, DE

Deutsche Balaton Aktiengesellschaft, DE

Baloise Holding AG, DE

Deutscher Ring Krankenversicherungsverein a.G., DE

Freefloat

• Convertible bond 2017/2025 (8 years, 6% interest rate); Jan 2017 €4.99 m

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Key Data of Convertible Bonds

2016/2024 2017/2025

Amount €2.54 million €4.99 million

Issue date 25 Nov 2016 20 Jan 2017

Maturity date 29 Oct 2024 20 Jan 2025

Coupon 6% 6%

Interest payment date Quarterly Quarterly

Conversion price €1.50 €1.60

ISIN DE000A2BPDY4 DE000A2DANN4

Listing no no

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Outlook 2017

• Advance product development

• Focus on lead compound lefitolimod and successor molecules EnanDIM®

- IMPALA: Finalize patient recruitment short-term

- IMPULSE: Present study results in Q2

- TEACH study results extension phase by mid-year

- Ongoing recruitment for combination study with ipilimumab (Yervoy®)

- Advance pre-clinical study program for EnanDIM®

• Production: Execute tech transfer and start upscaling

• Partnering discussions / Out-licensing activities to accelerate

• Ensure financing beyond early 2018

• R&D expenses will further increase due to study progress; operating results

below FY 2016 expected - dependent on financing structure

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Financial Calendar 2017 and Contact Details

22 March 2017

Full Year Report 2016

28 April 2017

Annual General Meeting

11 May 2017

Quarterly Statement as of 31 March 2017

10 August 2017

Half-Yearly Financial Report as of 30 June 2017

9 November 2017

Quarterly Statement as of 30 September 2017

Claudia Nickolaus

Head of Investor Relations &

Corporate Communications

Phone: +49-30-841788-38

Fax: +49-30-841788-50

[email protected]

www.mologen.com

MOLOGEN®, MIDGE®, dSLIM®, and EnanDIM® are registered trademarks of the MOLOGEN AG

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Agenda

Business Overview and Update on Operations 4

Key Financials and Outlook 13

Appendix 19

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Agenda

Highlights H1 2017 Onwards

Update Operations

Key Financials H1 2017 and Outlook 2017

Appendix

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IMPULSE: Exploratory Phase II Randomized Study

in Small Cell Lung Cancer (SCLC)

Study design

• Controlled, two-arm, multinational trial with 102 pts in Belgium, Austria, Germany and Spain

• Biomarkers used as stratification factors: NSE level and NKT activation

Efficacy

• Primary endpoint: overall survival (OS)

• Secondary endpoints: progression-free survival (PFS), best objective response rate (ORR), quality

of life (QOL), biomarkers

Safety

PD

Trial Treatment Period

Maintenance

Induction CT

4 cycles of

platinum-based

therapy

Standard first-line

CT for extensive

disease SCLC

PR/CR

Responder

Screening/

Randomization

3:2

Experimental Group:

5th cycle of platinum based

CT followed by lefitolimod

(MGN1703) maintenance

Control Group:

5th cycle of platinum

based CT followed by

local practice

PD

PD

Start of

2nd line

CR complete response | CT chemotherapy | NKT Natural Killer T cells | NSE neuron specific enolase - a tumor marker for lung cancer

PD progressive disease | PR partial response | SCLC small cell lung cancer

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IMPULSE: Favorable Safety Profile of Lefitolimod Confirmed

The most common adverse events (AE) in the IMPULSE population were:

Adverse events Lefitolimod Control Group

Cough 25.0% 7.7%

Asthenia 13.3% 17.9%

Headache 21.7% 5.1%

Nausea 11.7% 20.5%

Back pain 13.3% 12.8%

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mCRC Program: Phase III (Ongoing)

Pivotal IMPALA Study

• Primary endpoint overall survival (OS)

• Open-label, randomized, controlled, two-arm, multinational phase III trial

• 540 patients in around 120 sites in 8 European countries, including

top 5 European pharma markets

• Biomarkers used as stratification factors: CEA level and NKT activation

PD

Lefitolimod

(MGN1703)

Trial Treatment Period

Re-Induction

Induction CT

12–30 weeks

Standard first-line

CT for mCRC

PR/CR

Responder

Screening/

Randomization

1:1 Control

group PD

Lefitolimod

(MGN1703)

with

induction CT

Induction

CT

PD

Start of

2nd line

PD

Legend: CEA carcinoembryonic antigen - a tumor marker for colorectal cancer | CT chemotherapy | CR complete response | mCRC

metastatic colorectal cancer | NKT Natural Killer T cells | PD progressive disease | PR partial response

Maintenance

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Combination Trial:

Lefitolimod (MGN1703) and Ipilimumab (Yervoy®)

Study Outline

• Open-label, single site, phase I trial

• Patients with advanced solid tumors

• Primary endpoints: Safety, toxicity, MTD, and DLTs of combination therapy; dose finding for phase 2

• Dose escalation part followed by three expansion cohorts:

• Dose escalation: Six lefitolimod dose levels (3.75 – 120 mg) with up to 6 patients per dose level to find MTD;

• Once MTD is determined, patients will be enrolled in three expansion cohorts (5-12 patients each) at this dose to further define this dose and to help determine biological endpoints.

• Expansion Cohorts (Malignancy / Variable): (1) Melanoma / lefitolimod SC; (2) Melanoma / lefitolimod IT; (3) Advanced malignant diseases / recent radiation to tumor

Treatment Course

• Lefitolimod (MGN1703) administered weekly, SC (dose escalation and 2 expansion cohorts) or IT (one expansion cohort)

• ipilimumab always administered at 3mg/kg IV every 3 weeks

• Patients will receive treatment for 4 cycles – a total of 12 weeks

• Treatment will be discontinued in case of disease progression

• If patients demonstrate stable disease or a response, they will be eligible to continue to receive lefitolimod for up to a year

Legend: MTD maximum tolerated dose | DLT dose limiting toxicities | SC subcutaneous | IT intratumoral | IV intravenous

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Quarterly / FY Key Financials

in € million Q2

2017

Q1

2017

FY

2016

Q4

2016

Q3

2016

Q2

2016

Q1

2016

FY

2015

Q4

2015

Q3

2015

Q2

2015

R&D expenses 4.1 3.9 17.0 6.5 3.4 3.4 3.7 16.8 6.4 5.2 2.8

EBIT -5.4 -5.1 -21.0 -6.7 -4.5 -5.3 -4.5 -20.5 -7.2 -6.4 -3.7

CF from operating

activities -5.2 -6.0 -19.3 -5.4 -4.7 -4.8 -4.4 -15.1 -6.1 -4.3 -2.5

CF from financing

activities -0.1 4.9 15.2 15.7 -0.5 0.0 0.0 26.2 0.1 0.0 26.8

Monthly cash burn 1.8 2.0 1.7 1.9 1.7 1.6 1.5 1.4 2.0 1.5 1.4

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H1 2017 RESULTS DR MARIOLA SOEHNGEN – CEO WALTER MILLER - CFO

BERLIN, 10 AUGUST 2017

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www.mologen.com