H1 2018 RESULTS DR IGNACIO FAUS - CEO WALTER MILLER - CFO BERLIN, 9 AUGUST 2018 - mologen ag
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H1 2018 RESULTS DR IGNACIO FAUS – CEO WALTER MILLER – CFO BERLIN, 9 AUGUST 2018 1
DISCLAIMER This presentation does not constitute an offer to buy shares or other securities of MOLOGEN AG and does not replace the prospectus. This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, securities to any person in the United States of America (the “United States”), Australia, Canada or Japan or in any jurisdiction. The securities referred to in this announcement will not be and have not been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”) and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements under the U.S. Securities Act. There will be no public offer of the securities in the United States. Subject to certain exceptions, the securities referred to in this announcement may not be offered or sold in Australia, Canada or Japan, or to, or for the account or benefit of, any national, resident or citizen of Australia, Canada or Japan. The offer and sale of the securities referred to in this announcement has not been and will not be registered under the U.S. Securities Act or under the applicable securities laws of Australia, Canada or Japan. There will be no public offer of the securities in the United States. Note about risk for future predictions 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. 2
AGENDA Highlights H1 2018 and Onwards 4 Key Financials 13 Financing – Capital Measures 14 Outlook 2018 16 Appendix 18 3
HIGHLIGHTS H1 2018 AND ONWARDS
Pivotal phase III trial IMPALA on track, IMPULSE results confirmed, new
studies in preparation:
• IMPALA: Data-based prediction for the primary analysis date of the IMPALA
study deviates only moderately from the previous forecast and enables a
significantly higher degree of planning security
• IMPULSE: Final evaluation of the exploratory phase II study confirms
positive signals from initial evaluation in predefined subgroups
Operations: • New studies in different indications in preparation, e.g. TITAN in HIV
lefitolimod Strategy “Next Level”: ongoing implementation of measures:
• First licensing and development agreement signed: ONCOLOGIE for
licensing in China, Hong Kong & Macao, Taiwan, Singapore, and global
co-development: 02/18
• Outsourcing production
• Ongoing partnering/out-licensing discussions
• Negotiations regarding the divestment/spin-off of the MIDGE®-platform:
supported by grant for development of MIDGE-based leishmaniasis vaccine
4HIGHLIGHTS H1 2018 AND ONWARDS
• Signed licensing and co-development contract: first licensing revenue of
€3 million
• Financing capability restored: reverse share split in a ratio of 5:1 concluded
in July
Financials:
• R&D expenditure below the same period of the previous year, as the focus
was on the pivotal IMPALA study
• EBIT was significantly higher than in the same period of the previous year
due to the first licensing revenue
• Dr Ignacio Faus joined as new CEO in August 2018
Boards: • Dr Michael Schultz was appointed to new member of the Supervisory Board
at Annual General Meeting June 8, 2018
5FIRST LICENSE DEAL WITH ONCOLOGIE (1/2)
Feb 2018: MOLOGEN signed a license deal with ONCOLOGIE
• License agreement for lefitolimod in China incl. Hong Kong,
Macao, Taiwan and Singapore
• Global co-development agreement: indications to be defined
Overview ONCOLOGIE:
• Objective to develop novel personalized medicines in the field of immuno-oncology
• Dedicated to biomarker-driven development of large and small molecules for immuno-
oncology
• Headquartered in Boston, US, with operations in Shanghai, China
• Pivotal: Strong investor (US$ 150 million Venture Fund)*
• Additionally, Pivotal bioVenture Partners China Fund, Nan Fung Life Sciences, China
Merchant Bank Investments and Volcanics Ventures put together a US$16.5 million round
for ONCOLOGIE**
6 Sources: *https://endpts.com | **https://www.fiercebiotech.comMAIN TERMS OF THE CONTRACT WITH ONCOLOGIE
IN DETAIL (2/2)
• Initial payment of €3 million received
• Equity investment of ONCOLOGIE of €2 million within a period of 12 months following
the execution of the final license agreement
• In total payments of over €100 million over several years upon achievement of certain
development and commercial milestones for lefitolimod in the defined territory and field
• Low double digit royalties on potential future net sales of lefitolimod
• All costs relating to development, registration, marketing and commercialization
of lefitolimod in the defined territory to be covered by ONCOLOGIE
• Unleash Asian market potential of lefitolimod and further develop compound
7PRODUCT PIPELINE - FOCUS ON CANCER IMMUNOTHERAPIES
WITH WIDE RANGE OF POTENTIAL INDICATIONS
STUDIE Preclinical PHASE I PHASE II PHASE III
LEFITOLIMOD - DNA-based TLR9 agonist (ISR)
mCRC
IMPALA
Monotherapy
SCLC (extensive disease)
IMPULSE
Monotherapy
Advanced solid tumors
IO-combination therapy1 with ipilimumab
HIV2
TEACH
Monotherapy3
HIV2
TITAN
IO-combination therapy4
Solid tumors
IO-combination therapy
EnanDIM® - DNA-based TLR9 agonist (ISR)
Oncology & Anti-infectives
MGN1601 - Therapeutic vaccine (cell-line)
Renal cancer ASET
Oncology Infectious diseases Oncology combination trials Oncology and infectious diseases
8 Notes: 1 Collaboration with MD Anderson-Cancer Center, Texas, US | 2 Collaboration with University Hospital Aarhus, Denmark |
3 HIV patients under antiretroviral therapy (ART) | 4 With virus-neutralizing antibodies | IO = Immuno-oncology |
ISR Immune Surveillance ReactivatorIMPULSE: POSITIVE RESULTS IN TWO SUBGROUPS OF PATIENTS
TREATED WITH LEFITOLIMOD (FINAL ANALYSES Q1/2018)
IMPULSE: Exploratory phase II controlled, two-arm, multinational trial with 103 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”: 0.53; 95% confidence interval “CI”: 0.26–1.08
2. Patients with reported Chronic Obstructive Pulmonary Disease (COPD),
a frequent underlying disease:
Hazard ratio “HR”: 0.48; 95% confidence interval “CI”: 0.20–1.17
• Paper describing the data accepted for publication in “Annals of Oncology”
• Results provide significant guidance for defining patient populations most likely
to benefit from lefitolimod
9LEFITOLIMOD AND CPI –
ONGOING AND FUTURE CLINICAL STUDIES
Combination study lefitolimod with ipilimumab (Yervoy®) in solid tumors
• Collaboration with MD Anderson Cancer Center, Texas, US
• First combination trial of lefitolimod with commercially available CPI ipilimumab
(Yervoy®, Bristol-Myers Squibb)
• Phase I study in patients with advanced solid tumors
• Part 1: Evaluation of safety, tolerability and to ascertain tolerable dosage
far advanced, completion planned in 2018
• Part 2: Evaluation of TME effects and first efficacy signals
early stage, Evaluation of possible measures to accelerate
Further combination studies lefitolimod / CPI in solid tumors
• In advanced planning in cooperation with leading clinical centers
• Initiation depending on financing
• First data package on safety of a lefitolimod / CPI combination and recommended dosage
expected in 2018, further studies being planned
10 Legend: CPI checkpoint inhibitorIMMUNOMODULATORY MODE OF ACTION
(TME)
Lefitolimod
• Lefitolimod triggers the migration of immune cells and further modification of the TME,
which leads to the elimination of tumor cells and strengthens the effect of CPI
11 Legend: CPI checkpoint inhibitorsFROM TEACH TO TITAN – SETTING THE COURSE FOR
FUTURE DEVELOPMENT OF LEFITOLIMOD IN HIV
TEACH - lefitolimod with ART in HIV
• Remarkable immunostimulatory potency confirmed
• Eradication of HI viral reservoir not achieved
• Favorable safety profile in combination with ART confirmed
• Solid basis for future combination studies with more anti-HIV-agents
TITAN - lefitolimod in combination with virus-neutralizing antibodies and ART in HIV
• Collaboration with University Hospital Aarhus, Rockefeller Institute and further renowned
international centers
• Funded by a grant from Gilead
• Planned start: 2018
• Next stage of development in HIV ensured
• “External approval“ of lefitolimod’s large potential in HIV by acknowledged experts and a
leading pharmaceutical company
12 Legend: ART antiretroviral therapyKEY FINANCIALS H1 2018
Q2 Q2 H1 H1
In € m ∆% ∆%
2018 2017 2018 2017
Revenues 0.0 3.0 n.a. 3.0 0 n.a.
R&D expenses 2.7 4.1 34 5.6 8.0 30
EBIT -3.8 -5.4 30 -4.5 -10.5 57
CF from operating activities -1.9 -5.2 64 -6.5 -11.2 42
CF from financing activities -0.1 -0.1 - 6.2 4.8 28
Monthly cash burn 0.6 1.7 64 1.1 1.9 39
30 June 31 Dec
In € m ∆%
2018 2017
Total assets 8.0 8.1 -1
Cash & cash equivalents 6.2 6.5 -4
Equity -3.3 -4.9 33
Equity ratio -41% -60% 32
13 Legend: CF cash flowsFINANCING – CAPITAL MEASURES IN 2017 ONWARDS
CURRENT SHAREHOLDER STRUCTURE
In €m
• Convertible bond 2017/2025 (8 years, 6% interest rate) ~5.00
• Share Subscription Facility with GCF, US: capital increases in Oct ‘17/Feb ‘18 1.05
• Capital increase with subscription rights: Mar ‘18 ~5.00
• Financing Agreement with EHGO, LUX: concluded in Feb 18 1.00
Total gross proceeds ~12.00
• Cash reach until presumably end of 2018 - based on capital measures and framework
agreements concluded in 2017 and 2018 and the first payment of ONCOLOGIE
Shareholder Structure as at January 2018 (estimates)
Global Derivative Trading GmbH, DEFINANCING – CAPITAL MEASURES/SHARE
Capital increase with subscription rights
• All new shares placed: gross proceeds of around €5 million
• More than 60% of the new shares were acquired by existing shareholders
• Binding commitments were given by:
• Donau Invest Beteiligungs Ges.m.b.H (Donau Invest)
• U.S. investor Global Corporate Finance (GCF) – within private placements
• Global Derivate Trading GmbH (GDT) in particular contributed and European High Growth
Opportunities Securitization contributed within private placement
Reverse share split in a ratio of 5:1 - New ISIN: DE000A2LQ900
• The number of shares being reduced from 37,686,439 to 7,537,287
(new share capital = €7,537,287)
• The reduction in capital and stock consolidation has no significant impact on the assets of
shareholders; no change of capital structure and overall value of MOLOGEN AG
• MOLOGEN is again eligible for funding: already agreed financing instruments can be
further implemented; new capital measures can be conducted
15OUTLOOK 2018
• Focus on near-to-market lead compound lefitolimod and successor molecules EnanDIM®
• IMPALA: Continue treatment according to the study protocol
• IMPULSE: Analyses with international experts will lead to follow-on development strategy
• Complete patient recruitment for combination study with ipilimumab (Yervoy®)
• TITAN: Prepare start of the study
• EnanDIM®: Complete pre-clinical development; discuss potential clinical study program
• ONCOLOGIE: Define additional development program for lefitolimod
• Production: Execute tech transfer and start upscaling
• Partnering discussions; conclude additional licensing agreements for additional regions
• Ensure further financing beyond end of 2018
• R&D expenses are expected to be comparable to the previous year level or below -
depending on study programs and upscaling of the production; operating result is
expected to be on prior-year’s level – subject to additional partnerships and financing
structure
16FINANCIAL CALENDAR 2018 AND CONTACT DETAILS
25 April 2018
Full Year Report 2017
15 May 2018
Quarterly Statement as of 31 March 2018
8 June 2018
Annual General Meeting
9 August 2018
Half-Yearly Financial Report as of 30 June 2018
8 November 2018 Claudia Nickolaus
Quarterly Statement as of 30 September 2018 Head of Investor Relations &
Corporate Communications
Phone: +49-30-841788-38
Fax: +49-30-841788-50
investor@mologen.com
www.mologen.com
17 MOLOGEN®, MIDGE®, dSLIM®, and EnanDIM® are registered trademarks of the MOLOGEN AGAPPENDIX TEACH: Phase Ib/IIa Study 19 IMPALA: Phase III Study 21 Financing agreement “EHGO” 22 Financial Information 24 18
TEACH Trial: Study Design and Main Results
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
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
19Grant by Gilead for Combination Study in HIV “TITAN”
with Lefitolimod
• Aarhus University Hospital received US$2.75 million 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
Study is expected to start in 2018
20 Legend: ART antiretroviral therapymCRC PROGRAM: PHASE III (ONGOING)
PIVOTAL IMPALA STUDY
Trial Treatment Period
MAINTENANCE RE-INDUCTION SURVEILLANCE
Experimental: Experimental:
Lefitolimod PD Lefitolimod PD
Induction CT 60 mg s.c. PD
with induction CT
12–30 weeks Screening/ Start of
PR/CR
Randomization second-line
Responder
Standard first-line 1:1 therapy
CT for mCRC Control: Control:
PD PD
Local maintenance* Induction CT
*in case of continued first-line therapy PD directly results in start of second-line therapy at investigators’ discretion
• 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
21 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 responseFEB 2018: FINANCING AGREEMENT WITH EUROPEAN HIGH
GROWTH OPPORTUNITIES SECURITIZATION FUND “EHGO” (1/2)
• EHGO committed to subscribe for convertible bonds of MOLOGEN in an aggregated
amount of up to €12 m in up to 24 tranches of €500,000 each at MOLOGEN’s request
• Commitment period: 24 months
• EHGO can convert the bonds at their discretion – mandatory conversion upon
the lapse of 12 months from the issuance of the relevant tranche:
• Conversion price = 90% of three-day VWAP: three-day volume weighted
average price of consecutive trading days (XETRA) preceding the relevant
conversion date but at least 80% of the VWAP over ten trading days
preceding the issuance of the bonds
• EHGO covenants that they will not enter into or execute any “short sale” of
MOLOGEN shares during the pricing period (period of three days preceding
the relevant conversion date)
22FEB 2018: FINANCING AGREEMENT WITH EUROPEAN HIGH
GROWTH OPPORTUNITIES SECURITIZATION FUND “EHGO” (2/2)
• MOLOGEN is free to conduct additional financing measures during the term
of the agreement with other parties
• Use of proceeds: to finance MOLOGEN’s operations, and to further implement its
strategy “Next Level”, including the outsourcing of the production
EHGO, LUX: Institutional investment vehicle focusing on financing highly innovative
companies on a pan-European basis that it considers highly undervalued; funded out
of the Alpha Blue Ocean Partner’s Equity, and is exclusively advised by Alpha Blue
Ocean Advisors based in London, UK
• Funding secured until the end of 2018 – based on capital measures carried out
in 2017 and in Q1 2018 as well as additional framework agreements, together with first
payment from the licensing and development agreement
23QUARTERLY AND FY KEY FINANCIALS
Next Q2 Q1 FY Q4 Q3 Q2 Q1 FY Q4 Q3 Q2
In € mlevel strategy including upscaling: R&D expenses to increase in the mid- and
long-term 2018 2018 2017 2017 2017 2017 2017 2016 2016 2016 2016
R&D expenses 2.7 2.9 14.0 3.4 2.6 4.1 3.9 17.0 6.5 3.4 3.4
EBIT -3.8 -0.7 -18.7 -4.2 -4.0 -5.4 -5.1 -21.0 -6.7 -4.5 -5.3
CF from operating
-1.9 -4.6 -19.1 -3.7 -4.2 -5.2 -6.0 -19.3 -5.4 -4.7 -4.8
activities
CF from financing
-0.1 6.3 5.1 0.4 -0.1 -0.1 4.9 15.2 15.7 -0.5 0.0
activities
Monthly cash burn 0.6 1.6 1.7 1.2 1.5 1.7 2.0 1.7 1.9 1.7 1.6
24H1 2018 RESULTS DR IGNACIO FAUS – CEO WALTER MILLER – CFO BERLIN, 9 AUGUST 2018 25
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