ANALYSTS' & INVESTORS' CONFERENCE CALL - 27 MAY 2019 DR MED STEFAN M. MANTH - CEO - mologen ag
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ANALYSTS’ & INVESTORS’ CONFERENCE CALL DR MED STEFAN M. MANTH - CEO DR MED MATTHIAS BAUMANN - CMO 27 MAY 2019 1
AGENDA
Highlights 2018 and Onwards 3
License deal with ONCOLOGIE 5
Update Operations 6
Key Financials and Outlook 2019 12
Appendix 16
2HIGHLIGHTS FY 2018 AND ONWARDS (1/2)
Lefitolimod:
• SCLC: IMPULSE – Results of exploratory Phase II study presented at
ESMO 2018 and published in Annals of Oncology; further development
strategy designed in collaboration with leading international experts
• mCRC: IMPALA - Pivotal phase III study, first top line results expected in
summer 2019
• CPI combination study at MD Anderson: Successful conclusion of the
Operations: first part of the study; confirmation of safety, tolerability profile and first
Lefitolimod & encouraging TME modulation findings accepted for presentation at
ASCO 2019
EnanDIM®
• Other mono- and combination studies in different indications designed
• HIV: Detailed results of the TEACH – Phase Ib/IIa study published; in
support of further development in combination with monoclonal antibodies:
TITAN – Study about to enroll patients
EnanDIM®:
• Clinical candidate phase I-readiness expected by end of 2019 for
oncology
3HIGHLIGHTS FY 2018 AND ONWARDS (2/2)
• MOLOGEN & OncologiE International Inc.: License for China and global
Strategy: oncology therapy development alliance
• Ongoing partnering discussions
• Partnership with OncologiE: First licensing revenue of €3 million received;
€2 million convertible bond subscribed by OncologiE
• Set of financing measures implemented in 2018/2019, together with
Financials: licensing income MOLOGEN realized proceeds of around €27 million to
date
• Use of funds to fuel operations, in particular the phase III IMPALA trial
• Cash reach at estimated burn-rate until the end of 2019
• Dr Michael Schultz was appointed to the Supervisory Board and confirmed
at the Annual General Meeting in June 2018
Governance:
• Dr med Stefan M. Manth joined executive team as the new CEO in May
2019
4STRATEGIC ALLIANCE WITH ONCOLOGIE INT’L, INC.
• Feb 2018: MOLOGEN entered into a strategic alliance with OncologiE International Inc.
• License to develop, manufacture and commercialize lead compound Lefitolimod in
China, Hong Kong, Macao, Taiwan, and Singapore
• Global Co-development with a focus on combination therapies
• OncologiE International, Inc. (www.oncologie.international):
• Successfully closed a Series B financing round in May
• On a mission to build a global immuno-oncology therapy development presence
• Has a clinical development team on ground in China
• Staffed with and managed by industry professionals with in total over 60 man years
of experience in global oncology drug development
• Headquartered in Boston, USA, with operations in Boston and Shanghai
• The partnership is alive and at present jointly designing first combination trials
5PIPELINE: IMMUNOTHERAPIES WITH WIDE RANGE OF
POTENTIAL INDICATIONS
STUDY Preclinical PHASE I PHASE II PHASE III
LEFITOLIMOD
mCRC
IMPALA
Monotherapy
SCLC (extensive stage)
IMPULSE
Monotherapy
Advanced solid tumors1
IO-combination therapy
HIV2
TEACH
Monotherapy3
HIV2
TITAN
Combination therapy4
Solid tumors
IO-combination therapy
EnanDIM®
EnanDIM®
Candidates: Oncology
EnanDIM®
Candidates: HIV
MGN1601
Renal cancer ASET
1Collaboration with MD Anderson Center, Texas, US 2Collboration with University Hospital Aarhus, Denmark
Oncology
6 3HIV patients under retroviral therapy (ART) 4With broadly neutralizing antibodies
Infectious diseases IO=Immuno-oncology / mCRC = metastatic Colorectal Cancer / SCLC = Small Cell Lung CancerIMPALA - PIVOTAL PHASE III STUDY IN MCRC
NOW ON THE FINISHING LINE
Trial Treatment Period
Maintenance Re-Induction
Lefitolimod
PD with
Induction Lefitolimod PD
induction
chemo chemo
12–30 weeks Start of
PR / CR Screening/
2nd line
Randomization
(Standard
1st line chemo) Control Induction
PD PD
group chemo
• Primary endpoint: Overall survival (OS)
• Structure: Open, randomized, controlled, two-arm, multinational
• Size: 540 patients, 122 sites, 8 EU countries
• Readout: After 365 events
• Design: Maintenance therapy in patients with partial or complete response
to 1st line chemotherapy vs. local standard of care
• Timeline: Recruiting completed, top line data expected for summer 2019
• IMPALA was designed to support regulatory approval based on a significant OS benefit
7 Notes: Chemo chemotherapy | PR partial response | CR complete response | PD progressive diseaseIMPULSE – EXPLORATORY PHASE II STUDY IN SCLC
POSITIVE RESULTS IN RELEVANT PATIENT SUBGROUPS
IMPULSE: Exploratory phase II controlled, two-arm, multinational trial including 103 patients
with extensive disease stage small cell lung cancer (ES-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
• In two predefined and clinically relevant subgroups of patients, positive OS efficacy
signals were seen:
Patients with a low count of activated B-cells, an important immune parameter
Patients with reported COPD, a frequent underlying disease
• Final results presented at ESMO 2018 (EUROPEAN SOCIETY FOR MEDICAL
ONCOLOGY) in Munich in October 2018 and published in “Annals of Oncology “
• Strategy for further development in SCLC elaborated in the context of current competitive
environment in collaboration with leading international experts
8LEFITOLIMOD IN COMBINATION WITH CPI – FIRST ENCOURAGING
RESULTS OBTAINED, FURTHER STUDIES IN PREPARATION
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
successfully completed in 2018; encouraging data including beneficial effects on
the TME presented at the SITC meeting 2018 in Washington
• Part 2: Extension for further evaluation of TME effects and first efficacy signals:
ongoing
Further combination studies lefitolimod / CPI in solid tumors
• In advanced planning in cooperation with leading international centers
• Initiation depending on financing
• Lefitolimod – highly promising partner for combination therapies in immuno-oncology
9 Legend: CPI checkpoint inhibitor | TME tumor microenvironmentFROM TEACH TO TITAN – SETTING THE COURSE FOR
FUTURE DEVELOPMENT OF LEFITOLIMOD IN HIV
TEACH - lefitolimod with ART in HIV
• Remarkable immuno-activating potency confirmed
• Eradication of HI viral reservoir not achieved
• Favorable safety profile in combination with ART confirmed
• Solid basis for future combination studies with other anti-HIV-agents
TITAN - lefitolimod in combination with broadly 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
• Dosing of first patient expected in summer 2019
• Next step of lefitolimod development in HIV secured
• “External approval“ of lefitolimod’s large potential in HIV by acknowledged experts and a
leading pharmaceutical company
10 Legend: ART antiretroviral therapyGRANT FROM GILEAD FOR COMBINATION STUDY IN HIV
“TITAN”
Aarhus University Hospital received 2.75 m 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 and improved immunological control compared to
standard HIV treatment regimens, i.e. ART
• Promising potential for the combination of lefitolimod with virus-neutralizing antibodies
supported by the results of the TEACH study
• Dosing of first patients expected in summer 2019
11 Legend: ART antiretroviral therapyKEY FINANCIALS Q1 2019 AND FY 2018 (IFRS)
Q1 Q1 FY FY
In € m ∆* ∆*
2019 2018 2018 2017
R&D expenses 2.2 2.9 25% 10.3 14.0 26%
EBIT -3.6 -0.7 -405% -11.3 -18.7 39%
Cash flows from operating activities -4.3 -4.6 7% -13.7 -19.1 28%
Cash flows from financing activities 2.7 6.3 -57% 15.2 5.1 198%
Monthly cash burn 1.3 1.6 19% 1.1 1.7 35%
31 Mar 31 Dec 31 Dec 31 Dec
In € m ∆* ∆*
2019 2018 2018 2017
Total assets 7.9 9.4 -15% 9.4 8.1 16%
Cash & cash equivalents 6.5 8.0 -19% 8.0 6.5 23%
12 * Economic view / minus = neg. impact on business, plus = pos. impactFINANCING – 2018 UP TO DATE
In €m
Initial payment from ONCOLOGIE (licensing agreement Greater China 04/18) 3.0
Convertible bonds ONCOLOGIE (5 years, 0% interest rate) 2.0
Share Subscription Facility with GCF, US: up to 10% of outstanding MGN shares 1.0
Financing Agreement with EHGO, LUX 1.0
Capital increase with subscription rights – April 2018 ~ 5.0
Capital increase with subscription rights – September 2018 ~ 8.2
Convertible bonds 2019/2027 (8 years, 6% interest rate) ~ 2.7
Capital increase with subscription rights – April 2019 ~ 4.2
Total gross proceeds ~ 27.1
• Cash reach presumably until end of 2019 - based on current cash position
13 Legend: EHGO European High Growth Opportunities | GCF Global Corporate FinanceOUTLOOK 2019
• Focus on near-to-market lead compound lefitolimod and successor molecules EnanDIM®
• Q3: TITAN dosing of first patient
• Q3: IMPALA top line data expected
• Q4: EnanDIM® phase I-ready
• Ongoing partnering discussions
• Further financing beyond end of 2019 to be secured
• Additional combination trials in oncology to go live
• Outcome of IMPALA study has significant impact on further development of the Company
14FINANCIAL CALENDAR 2019 AND CONTACT DETAILS
30 April 2019
Full Year Report 2017
9 May 2019
Quarterly Statement as of 31 March 2019
14 August 2019
Half-Yearly Financial Report as of 30 June 2019
22 August 2019
Annual General Meeting Claudia Nickolaus
Head of Investor Relations &
7 November 2019
Corporate Communications
Quarterly Statement as of 30 September 2019
Phone: +49-30-841788-37
Fax: +49-30-841788-50
investor@mologen.com
www.mologen.com
15 MOLOGEN®, MIDGE®, dSLIM®, and EnanDIM® are registered trademarks of the MOLOGEN AGQUARTERLY AND FY KEY FINANCIALS
Q1 FY Q4 Q3 Q2 Q1 FY Q4 Q3 Q2 Q1
In € million
2019 2018 2018 2018 2018 2018 2017 2017 2017 2017 2017
R&D expenses 2.2 10.3 1.9 2.8 2.7 2.9 14.0 3.4 2.6 4.1 3.9
EBIT -3.6 -11.3 -2.5 -4.3 -3.8 -0,7 -18.7 -4.2 -4.0 -5.4 -5.1
CF from operating
-4.3 -13.7 -3.7 -3.5 -1.9 -4.6 -19.1 -3.7 -4.2 -5.2 -6.0
activities
CF from financing
2.7 15.2 9.5 -0.5 -0.1 6.3 5.1 0.4 -0.1 -0.1 4.9
activities
Monthly cash burn 1.3 1.1 1.0 1.2 0.6 1.6 1.7 1.2 1.5 1.9 2.0
16DISCLAIMER 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. 17
ANALYSTS’ & INVESTORS’ CONFERENCE CALL DR MED STEFAN M. MANTH - CEO DR MED MATTHIAS BAUMANN - CMO 27 MAY 2019 18
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