Translating cancer antibody biology for life
ADVANCING CANCER IMMUNOTHERAPIES
October 2018
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Nasdaq Stockholm: BINV.ST ~ 350 million ordinary shares outstanding Market Capitalization: ~ €90 million
ADVANCING CANCER IMMUNOTHERAPIES Nasdaq Stockholm: BINV.ST October - - PowerPoint PPT Presentation
Translating cancer antibody biology for life ADVANCING CANCER IMMUNOTHERAPIES Nasdaq Stockholm: BINV.ST October 2018 ~ 350 million ordinary shares outstanding Market Capitalization: ~ 90 million 1 FORWARD-LOOKING STATEMENTS This
Translating cancer antibody biology for life
ADVANCING CANCER IMMUNOTHERAPIES
October 2018
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Nasdaq Stockholm: BINV.ST ~ 350 million ordinary shares outstanding Market Capitalization: ~ €90 million
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FORWARD-LOOKING STATEMENTS
This presentation does not constitute or form part of any offer or invitation to purchase or subscribe for, or any offer to underwrite or otherwise acquire, any shares or any
This presentation contains forward-looking statements, which are subject to risks and uncertainties because they relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. All statements other than statements of historical fact included in this presentation are forward-looking statements. Forward-looking statements give BioInvent’s current expectations and projections relating to its financial condition, results of operations, plans, objectives, future performance and business. These statements may include, without limitation, any statements preceded by, followed by or including words such as “target,” “believe,” “expect,” “aim,” “intend,” “may,” “anticipate,” “estimate,” “plan,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could” and other words and terms of similar meaning or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of BioInvent or the industry in which it operates, to be materially different than any future results, performance or achievements expressed or implied by such forward-looking statements. Given these risks, uncertainties and other factors, recipients of this presentation are cautioned not to place undue reliance on these forward-looking statements. The forward-looking statements referred to above speak only as at the date of the presentation. BioInvent will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect future events, circumstances, anticipated events, new information or otherwise except as required by law or by any appropriate regulatory authority. The information included in this presentation may be subject to updating, completion, revision and amendment and such information may change materially. No person, including BioInvent and its advisors, is under any obligation to update or keep current the information contained in this presentation and any opinions expressed in relation thereto are subject to change without notice. Neither BioInvent nor any of its owners, affiliates, advisors or representatives (jointly the “Disclosers”) make any guarantee, representation or warranty, express or implied, as to the accuracy, completeness or fairness of the information and opinions contained in this presentation, and no reliance should be placed on such information. None of the Disclosers accept any responsibility or liability whatsoever for any loss howsoever arising from any use of this presentation or its contents or otherwise arising in connection therewith. By attending this presentation or by accepting any copy of this document, you agree to be bound by the foregoing limitations.
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– Leading antibody immuno-oncology platform:
– Robust pipeline fueled by strong, fully integrated research engine:
– Validating deal with Pfizer
– Financial position:$16 million cash on hand at 30 June, 2018
Investments, Rhenman Healthcare Equity
– Experienced management team with big pharma and biotech experience
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INVESTMENT HIGHLIGHTS
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A RAPIDLY GROWING MARKET: Expected to reach sales
THE CONCEPT WORKS: New drugs direct the immune system to combat tumors ONLY A SUBSET OF PATIENTS RESPOND TO CURRENT DRUGS: New mechanisms and antibodies needed to improve outcomes
NEW DRUGS AND MECHANISMS ARE NEEDED TO IMPROVE CANCER IMMUNOTHERAPY & SURVIVAL
BIOINVENT TARGETS KEY IMMUNE SUPPRESSIVE CELLS & MECHANISMS TO BOOST ANTI-CANCER IMMUNITY
F.I.R.S.T™- A PATIENT CENTRIC PLATFORM FOR DISCOVERY OF NOVEL ONCOLOGY TARGETS AND MAB
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PIPELINE – MULTIPLE VALUE DRIVERS
indication target program discovery preclinical Phase I Phase II
NHL (MCL, MZL, iFL) FcγRIIB BI-1206 / rituximab solid cancer αFcγRIIB solid cancer BI-1607 solid cancer Tregs αCTLA-4-GM- CSF-VV solid cancer αTNFRS (Emerging) solid cancer F.I.R.S.T™ αTreg solid cancer F.I.R.S.T™ αTAMs
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FcγRIIB – A SINGLE INHIBITORY ANTIBODY CHECKPOINT TO UNLOCK ANTI-CANCER IMMUNITY
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FcγRIIB – A SINGLE INHIBITORY ANTIBODY CHECKPOINT TO UNLOCK ANTI-CANCER IMMUNITY
Adaptive immunity Innate immunity Adaptive immunity
10 Vargas et al Cancer Cell 2018
FcγR-INTERACTIONS CO-DETERMINE EFFICACY OF CHECKPOINT INHIBITOR ANTIBODIES
αPD-L1 αPD-1
“FcγR engagement augments the anti-tumor activity
activity of anti-PD1 Abs.” Fc effector function contributes to the activity of human anti-CTLA-4 antibodies Fcγ receptors modulate the anti-tumor activity of antibodies targeting the PD-1/PD-L1 axis
Dahan et al Cancer Cell 2015
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BI-1206 IN NHL: TURBOCHARGING ANTI-CD20- $500 MILLION MARKET OPPORTUNITY
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BI-1206 IN NHL: TURBOCHARGING ANTI-CD20- $500 MILLION MARKET OPPORTUNITY
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BI-1206: CUTTING BOTH WAYS
From Roghanian et al Cancer Cell 2015, 27, 473
Human CD20 FcγRIIB double transgenic mice Humanized model of relapsed/refractory CLL
% objective responders (blue)
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BI-1206: EXPANDING THERAPEUTIC POTENTIAL - PHASE I/IIA STUDY
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A multicenter, open label, Phase I/IIa study in relapsed or refractory NHL patients enriched with Mantle Cell Lymphoma – US & EU
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High proportion of patients expressing CD32b in enriched population
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High unmet medical need – despite the availability of targeted therapies Objectives
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Safety & tolerability of BI-1206 in combination with rituximab
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PK/PD of the antibody
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Recommended phase 2 dose (RP2D)
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Signs of efficacy of the combination treatment
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Biomarker exploration (B-cell depletion, phosphorylation of FCγRIIB)
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VALUE PROPOSITION BI-1206 – KEY SEGMENTS & VALUE DRIVERS
Value drivers
patients
therapies
(~2-3yrs)
where anti-CD20 mAbs are used Safety, chemo-free regimen and scientific rationale in anti-CD20 refractory B-cell lymphoma are key drivers of BI-1206 attractiveness.
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TARGETING TREGS
microenvironment…
induces activation of CD8 T cells and TAMs…
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TARGETING TAMS
microenvironment…
education of TAMs…
and effector macrophage activation, resulting in death of tumor cells.
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MABS + ONCOLYTIC VIRUS TO TARGET SOLID TUMORS
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H2 2018
H1 2019
H2 2019
H1 2020
H2 2020
H1 2021
MILESTONES
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Provided courtesy of EMD Millipore Corporationproprietary programs
technology: 40L -1,000L batch sizes
from external customers
clinical trials in Europe, USA and Japan
PROPRIETARY MANUFACTURING PLATFORM SINCE 1988
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FINANCIAL HIGHLIGHTS
Shareholder list includes reputable institutions and sector specialist funds
Jan.-June Jan.-June Jan.-Dec. USD mln 2018 2017 2017 Net sales 2.5 2.7 5.3 Research and development costs
Sales and administrative costs
Other operating revenues and costs 0.1 0.0 0.4 Operating profit/loss
Profit/loss from financial investments 0.0 0.0 0.0 Profit/loss before tax
Tax
Liquid funds 16.2 22.8 16.2
In March 2018 the Company successfully completed a directed share issue of USD 10 million before issue costs. IM Europe (Institut Mérieux), not previously a shareholder in BioInvent, was the largest participant in the issue and became
Largest shareholders 30 Sep. 2018
Percentage of capital and votes Van Herk Investments B.V. 29.091.272 8,3 Omega Fund IV, LP 28.352.982 8,1 IMEurope (Institut Mérieux) 27.561.395 7,9 Avanza Pension Försäkring 22.850.035 6,5 Pfizer 21.973.594 6,3 Skandinaviska Enskilda Banken 14.128.316 4,0 Nordnet Pensionsförsäkring 13.753.646 3,9 Mexor i Skellefteå AB 9.706.713 2,8 East Bay AB 9.400.000 2,7 Peter Hoglin 7.689.173 2,2 Staffan Rasjö 7.555.139 2,2 Other shareholders 158.737.707 45,3 Total 350.799.972 100,0
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BIOINVENT MANAGEMENT TEAM
Martin Welschof, Chief Executive Officer Björn Frendéus, Chief Scientific Officer Stefan Ericsson, Chief Financial Officer Andres McAllister, Chief Medical Officer Kristoffer Rudenholm Hansson, SVP Technical Operations
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BIOINVENT’S SCIENTIFIC ADVISORY BOARD & BOARD OF DIRECTORS SAB BoD
Martin Glennie, University of Southampton Leonard Kruimer, Chair (ex-Crucell, ProFibrix) Falk Nimmerjahn, Friedrich-Alexander University Erlangen-Nürnberg Vessela Alexieva, Employee representative Rienk Offringa, German Cancer Research Center Kristoffer Bissessar, (ex-Handelsbanken, Deutsche Bank, Nordea) Tony Tolcher, NEXT Oncology; formerly at South Texas Accelerated Research Therapeutics Dharminder Chahal, (a.o. CEO SkylineDx, managing director at Exponential BV, Swanbridge Capital) Alexander Rudensky, Memorial Sloan Kettering Cancer Center Elin Jaensson Gyllenbäck, Employee representative An van Es Johansson, (SOBI AB; ex-Lilly, Roche, Pharmacia & Upjohn) Vincent Ossipow, (Omega Funds; ex-Sectoral, Pictet) Bernd Seizinger, (ex-GPC Biotech, BMS)
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– Leading antibody immuno-oncology platform:
– Robust pipeline fueled by strong, fully integrated research engine:
– Validating deal with Pfizer
– Financial position:$16 million cash on hand at 30 June, 2018
Investments, Rhenman Healthcare Equity
– Experienced management team with big pharma and biotech experience
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INVESTMENT HIGHLIGHTS
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Safety, chemo-free regimen and scientific rationale in anti-CD20 refractory B-cell lymphoma are key drivers of BI 1206 attractiveness Value Drivers
Key Segments Attractive opportunities:
also be evaluated with FL Attractive opportunities:
FL MZL MCL
Attractive opportunities:
be a safer option for patients ineligible for chemo or targeted therapies such as ibrutinib or other tyrosine kinase inhibitors (ibrutinib shows bleeding complications, atrial fibrillation and infection in a high percentage of patients)
Treatment Paradigm
MARKET & DISEASE OVERVIEW
Key Marketed/Late Stage Competition Key Commentary Marketed Bendamustine
Marketed Ibrutinib
Marketed Lenalidomide
Marketed Alacabrutinib
Phase III Venetoclax
setting. Phase II Ublituximab
Phase II Obinutuzumab
ibrutinib
Disease Overview
with advanced disease are limited to palliative treatments.
lymphoma patients, with median overall survival of 4-6 years.
Epidemiology & Market Size
with global incidence rate slightly lower at 0.5 cases per 100,000
Market Landscape
efficacy in the refractory or early relapse.
Current and Future Rituximab Settings
aggressive treatment programs and used extensively across all stages of MCL.
MCL Immunochemotherapy (RDHAP, RDHAX, R-CHOP, BR, R-Hyper-CVAD) ± ISRT Stage II Bulky/III/IV Stage I/II Localized
MCL
54 % 25 % 17 % 4%
Pipeline by Phase (n=43)
Phase 2 Marketed Phase 1 Phase 3
HDT/ASCR HDT/ASCR Ineligible Aggressive Immunochemotherapy Rituximab ± ibrutinib
10 000 2017 2018 2019 2020 2021 2022 2023 2024
USD M
US NHL Market (2017-2024;
Other Zanubrutinib (BEGN) Bendeka (TEVA) Blincyto (AMGN)
venetoclax acalabrutinib ISRT Immunochemotherapy HDT/ASCR Eligible Less Aggressive Immunochemotherapy RT Rituximab