ADVANCING CANCER IMMUNOTHERAPIES Nasdaq Stockholm: BINV.ST October - - PowerPoint PPT Presentation

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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


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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

  • ther securities in BioInvent International AB (“BioInvent”). Neither shall the presentation or any part of it, nor the fact of its distribution or communication, form the basis
  • f, or be relied on in connection with, any contract, commitment or investment decision in relation thereto.

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:

  • Advancing IO by overcoming tumor resistance
  • Validated by publications in top-tier journals and partnerships

– Robust pipeline fueled by strong, fully integrated research engine:

  • 2 proprietary programs in the clinic - key readouts 2019
  • Partnership to develop first-in-class antibody-expressing oncolytic viruses

– Validating deal with Pfizer

  • Development of anti-TAM antibodies
  • $3 million upfront & $6 million equity stake
  • Potential milestones > $500 million & up to double digit royalties

– Financial position:$16 million cash on hand at 30 June, 2018

  • Strong institutional shareholder base with a.o. Pfizer, Omega Funds, Institut Mérieux, Van Herk

Investments, Rhenman Healthcare Equity

– Experienced management team with big pharma and biotech experience

3

INVESTMENT HIGHLIGHTS

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A RAPIDLY GROWING MARKET: Expected to reach sales

  • f USD 34bn in 2024

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

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BIOINVENT TARGETS KEY IMMUNE SUPPRESSIVE CELLS & MECHANISMS TO BOOST ANTI-CANCER IMMUNITY

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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

  • BioInvent additionally has ownership in anti-PlGF programs TB-403 and THR-317 partnered with Oncurios and Oxurion
  • Two parallell Clinical Phase I/II studies ongoing with BI-1206 (BioInvent and CRUK sponsored)
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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

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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

  • f aPD-L1 Abs but compromises the anti-tumor

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

A multicenter, open label, Phase I/IIa study in relapsed or refractory NHL patients enriched with Mantle Cell Lymphoma – US & EU

High proportion of patients expressing CD32b in enriched population

High unmet medical need – despite the availability of targeted therapies Objectives

Safety & tolerability of BI-1206 in combination with rituximab

PK/PD of the antibody

Recommended phase 2 dose (RP2D)

Signs of efficacy of the combination treatment

Biomarker exploration (B-cell depletion, phosphorylation of FCγRIIB)

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VALUE PROPOSITION BI-1206 – KEY SEGMENTS & VALUE DRIVERS

Value drivers

  • First-in-class in hematology - no direct competitors
  • BI-1206 shows a favorable safety profile
  • High unmet need for chemotherapy-free, safer
  • ptions in 2nd Line
  • in Rituximab-refractory patients
  • in aggressive disease such as MCL
  • in transplant ineligible and elderly MCL

patients

  • In patients ineligible for chemo or targeted

therapies

  • Shorter clinical trials in 2nd Line and 3rd Line MCL

(~2-3yrs)

  • Strong scientific rationale
  • Possible label extension to all therapeutic areas

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

  • 1. Within a tumor

microenvironment…

  • 2. …killing of Tregs

induces activation of CD8 T cells and TAMs…

  • 3. …resulting in death
  • f tumor cells.
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TARGETING TAMS

  • 1. Within a tumor

microenvironment…

  • 2. …deletion or re-

education of TAMs…

  • 3. …promotes CD8 T cell

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

  • Start Phase I/IIa BI-1206/rituximab combination trial in NHL
  • Preclinical rationale Anti-CTLA-4/oncolytic virus, SITC Poster

H1 2019

  • BI-1206 /rituximab orphan drug designation (ODD) in mantle cell lymphoma
  • Podium Presentation SLAS 2019 Washington on F.I.R.S.T tm
  • Anti-FcγRIIB antibody/anti-PD1 start Phase I/IIa
  • BI-1206/rituximab poster presentation at Int. Conf. on Malignant Lymphoma

H2 2019

  • Pfizer collaboration: TAM target antibodies selection
  • Start phase IIa BI-1206/rituximab combination trial in NHL
  • BI-1607 (anti-FcγRIIB antibody)/checkpoint inhibitor, start Phase I PoC trial

H1 2020

  • Anti-FcγRIIB antibody/anti-PD1 start Phase IIa
  • BI-1206/rituximab I/IIa in NHL topline results
  • Anti-FcγRIIB antibody/anti-PD1 Phase I/IIa, ASCO poster
  • BI-1808 +/- anti-PD1, start Phase I

H2 2020

  • Transgene collaboration: Anti-CTLA-4/oncolytic virus, start Phase I/IIa

H1 2021

  • BI-1206/rituximab Phase I/IIa in NHL readout

MILESTONES

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Provided courtesy of EMD Millipore Corporation
  • Supports fast and flexible production of

proprietary programs

  • State of the art single use bioreactor (SUB)

technology: 40L -1,000L batch sizes

  • Approved for Phase l to lll production
  • Track record of 30 years inspections
  • Consistent source of near term revenues

from external customers

  • BioInvent has produced drug substance for

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

  • 8.9
  • 5.8
  • 12.9

Sales and administrative costs

  • 1.8
  • 2.1
  • 4.6
  • 10.7
  • 7.9
  • 17.4

Other operating revenues and costs 0.1 0.0 0.4 Operating profit/loss

  • 8.1
  • 5.2
  • 11.8

Profit/loss from financial investments 0.0 0.0 0.0 Profit/loss before tax

  • 8.1
  • 5.2
  • 11.8

Tax

  • Profit/loss
  • 8.1
  • 5.2
  • 11.8

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

  • ne of the largest shareholders of the Company.

Largest shareholders 30 Sep. 2018

  • No. of shares

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:

  • Advancing IO by overcoming tumor resistance
  • Validated by publications in top-tier journals and partnerships

– Robust pipeline fueled by strong, fully integrated research engine:

  • 2 proprietary programs in the clinic - key readouts 2019
  • Partnership to develop first-in-class antibody-expressing oncolytic viruses

– Validating deal with Pfizer

  • Development of anti-TAM antibodies
  • $3 million upfront & $6 million equity stake
  • Potential milestones > $500 million & up to double digit royalties

– Financial position:$16 million cash on hand at 30 June, 2018

  • Strong institutional shareholder base with a.o. Pfizer, Omega Funds, Institut Mérieux, Van Herk

Investments, Rhenman Healthcare Equity

– Experienced management team with big pharma and biotech experience

24

INVESTMENT HIGHLIGHTS

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Thank You

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Appendix

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Value Proposition

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:

  • 2nd Line+ (Relapsed/ refractory)
  • 2nd and 3rd Line opportunities can

also be evaluated with FL Attractive opportunities:

  • 2nd Line+ (Relapsed/ refractory)
  • 3rd Line+ (Relapsed/ refractory)
  • 1st Line transplant ineligible/elderly

FL MZL MCL

Attractive opportunities:

  • 2nd Line (Relapsed/ refractory)
  • 2nd Line (Rituximab refractory)
  • 3rd Line+ (Relapsed/ refractory)
  • High unmet need for chemotherapy-free, safer options in 2nd Line
  • Comparatively poor survival and fewer current Tx options in Rituximab-refractory patients
  • Need therapies that improve survival in aggressive disease such as MCL
  • mOS: ~20-24 months in MCL R/R settings (2nd Line, 3rd Line+)
  • Limited therapies available for transplant ineligible and elderly MCL patients
  • Trial duration shorter in both 2nd Line and 3rd Line MCL (~2-3yrs)
  • First-in-class in Hematology. No direct competitors
  • BI-1206 showed a favorable safety profile in preclinical and early clinical studies; BI-1206+ Rituximab can

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)

  • Strong scientific rationale
  • Possible label extension to all therapeutic areas where rituximab and other anti-CD20 mAbs are used
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Treatment Paradigm

MARKET & DISEASE OVERVIEW

Key Marketed/Late Stage Competition Key Commentary Marketed Bendamustine

  • Used primarily in conjunction with rituximab

Marketed Ibrutinib

  • Used ± rituximab, primarily in the 2L setting

Marketed Lenalidomide

  • Used ± rituximab, primarily in the 2L setting

Marketed Alacabrutinib

  • Used as monotherapy in 2L setting.

Phase III Venetoclax

  • Included in NCCN guidelines; used as monotherapy in the 2L

setting. Phase II Ublituximab

  • Anti-CD20 being evaluated in combination with Bendeka

Phase II Obinutuzumab

  • Anti-CD20 being evaluated in combination with Bendeka or

ibrutinib

Disease Overview

  • Mantle cell lymphoma (MCL) is a rare, aggressive form of B-cell NHL, with tumor cells
  • riginating in the mantle zone of the lymph node.
  • Currently available treatment programs are not curative, and treatments for patients

with advanced disease are limited to palliative treatments.

  • The prognosis of patients with MCL is the amongst the poorest among B-cell

lymphoma patients, with median overall survival of 4-6 years.

Epidemiology & Market Size

  • Relatively rare, accounting for 3-6% of new NHL cases (US – 2200-4400 cases (2018)),

with global incidence rate slightly lower at 0.5 cases per 100,000

Market Landscape

  • Rituximab-based immunochemotherapies remain the SOC for the treatment for MCL.
  • Recently approved targeted approaches like ibrutinib have demonstrated encouraging

efficacy in the refractory or early relapse.

  • Branded therapies are expected to drive the growth, despite generics/biosimilars.
  • Relatively small pipeline, with late stage agents mainly targeting CD antigens

Current and Future Rituximab Settings

  • Currently, Rituximab is combined with both, conventional chemotherapy regimens and

aggressive treatment programs and used extensively across all stages of MCL.

  • >20 late stage trials of various agents with rituximab in frontline and later settings.

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

  • r lenalidomide

10 000 2017 2018 2019 2020 2021 2022 2023 2024

USD M

US NHL Market (2017-2024;

  • nly MCL approved agents)

Other Zanubrutinib (BEGN) Bendeka (TEVA) Blincyto (AMGN)

venetoclax acalabrutinib ISRT Immunochemotherapy HDT/ASCR Eligible Less Aggressive Immunochemotherapy RT Rituximab

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