H RESULTS DR IGNACIO FAUS CEO WALTER MILLER CFO BERLIN, 9 AUGUST 2018

Transcription

1 H RESULTS DR IGNACIO FAUS CEO WALTER MILLER CFO BERLIN, 9 AUGUST

2 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 forwardlooking statements. It is not responsible for updating such information, which only represents the state of affairs on the day of publication. 2

3 AGENDA Highlights H and Onwards 4 Key Financials 13 Financing Capital Measures 14 Outlook Appendix 18 3

4 HIGHLIGHTS H AND ONWARDS Operations: lefitolimod 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 New studies in different indications in preparation, e.g. TITAN in HIV 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 4

5 HIGHLIGHTS H AND ONWARDS Financials: Boards: 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 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 Dr Michael Schultz was appointed to new member of the Supervisory Board at Annual General Meeting June 8,

6 FIRST 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 immunooncology 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: * **

7 MAIN 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 7

8 PRODUCT PIPELINE - FOCUS ON CANCER IMMUNOTHERAPIES WITH WIDE RANGE OF POTENTIAL INDICATIONS LEFITOLIMOD - DNA-based TLR9 agonist (ISR) STUDIE Preclinical PHASE I PHASE II PHASE III mcrc Monotherapy SCLC (extensive disease) Monotherapy IMPALA IMPULSE Advanced solid tumors IO-combination therapy 1 with ipilimumab HIV 2 Monotherapy 3 HIV 2 IO-combination therapy 4 Solid tumors IO-combination therapy TEACH TITAN EnanDIM - DNA-based TLR9 agonist (ISR) Oncology & Anti-infectives MGN 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 Reactivator

9 IMPULSE: 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 : Patients with reported Chronic Obstructive Pulmonary Disease (COPD), a frequent underlying disease: Hazard ratio HR : 0.48; 95% confidence interval CI : 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 9

10 LEFITOLIMOD 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 inhibitor

11 IMMUNOMODULATORY 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 inhibitors

12 FROM 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 therapy

13 KEY FINANCIALS H In m Q Q % H H Revenues n.a n.a. R&D expenses EBIT CF from operating activities CF from financing activities Monthly cash burn % In m 30 June Dec 2017 Total assets Cash & cash equivalents Equity Equity ratio -41% -60% 32 % 13 Legend: CF cash flows

14 FINANCING 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 Capital increase with subscription rights: Mar 18 Financing Agreement with EHGO, LUX: concluded in Feb ~5.00 Total gross proceeds ~ Cash reach until presumably end of 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) 59% <25% 3% 5% 4% 4% Global Derivative Trading GmbH, DE Axxion S.A., LUX Deutsche Balaton Aktiengesellschaft, DE Baloise Holding AG, DE SIGNAL IDUNA Krankenversicherung a.g., DE Freefloat 14 Legend: EHGO European High Growth Opportunities

15 FINANCING 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 15

16 OUTLOOK 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 16

17 FINANCIAL CALENDAR 2018 AND CONTACT DETAILS 25 April 2018 Full Year Report May 2018 Quarterly Statement as of 31 March June 2018 Annual General Meeting 9 August 2018 Half-Yearly Financial Report as of 30 June November 2018 Quarterly Statement as of 30 September 2018 Claudia Nickolaus Head of Investor Relations & Corporate Communications Phone: Fax: investor@mologen.com 17 MOLOGEN, MIDGE, dslim, and EnanDIM are registered trademarks of the MOLOGEN AG

18 APPENDIX TEACH: Phase Ib/IIa Study 19 IMPALA: Phase III Study 21 Financing agreement EHGO 22 Financial Information 24 18

19 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 19

20 Grant 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 Legend: ART antiretroviral therapy

21 mcrc PROGRAM: PHASE III (ONGOING) PIVOTAL IMPALA STUDY Trial Treatment Period MAINTENANCE RE-INDUCTION SURVEILLANCE Induction CT weeks Standard first-line CT for mcrc PR/CR Responder Screening/ Randomization 1:1 Experimental: Lefitolimod 60 mg s.c. Control: Local maintenance* PD PD Experimental: Lefitolimod PD with induction CT Control: Induction CT PD PD Start of second-line therapy * 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 response

22 FEB 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) 22

23 FEB 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 Q as well as additional framework agreements, together with first payment from the licensing and development agreement 23

24 QUARTERLY AND FY KEY FINANCIALS Next level strategy including Q2 Q1 upscaling: FY R&D Q4 expenses Q3 to Q2 In m increase Q1 in the FY mid- Q4 and Q3 long-term Q R&D expenses EBIT CF from operating activities CF from financing activities Monthly cash burn

25 H RESULTS DR IGNACIO FAUS CEO WALTER MILLER CFO BERLIN, 9 AUGUST