Immunicum Establishing a unique immuno-oncology approach by developing allogeneic, off-the-shelf, cell-based therapies

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Immunicum Establishing a unique immuno-oncology approach by developing allogeneic, off-the-shelf, cell-based therapies
Immunicum
Establishing a unique immuno-oncology approach
by developing allogeneic, off-the-shelf, cell-based
therapies

Investor presentation
May 2019
Immunicum Establishing a unique immuno-oncology approach by developing allogeneic, off-the-shelf, cell-based therapies
Disclaimer

This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical
facts, contained in this presentation, including statements regarding Immunicum’s view on strategy, future operations, future clinical development plans and
objectives, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The
words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “target”, “potential”, “will”, “would” “can”, “could”, “shall”,
“should”, “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such
identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place
undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in
the forward-looking statements we make. The forward-looking statements contained in this presentation reflect Immunicum’s current views with respect to
future events, and Immunicum assumes no obligation to update any forward-looking statements except as required by applicable law. Our actual results
and/or actual events could differ materially from those anticipated in forward-looking statements for many reasons, including, without limitation, risks
associated with our clinical development activities, chemistry, manufacturing and controls, regulatory oversight, product commercialization, upholding of
intellectual property rights or intellectual property claims, general market developments and other risks, uncertainties and factors within and outside of our
control. Given these risks, uncertainties and other factors, you should not place undue reliance on forward-looking statements, and we assume no
obligation to update forward-looking statements, even if new information becomes available in the future, or to provide information regarding the reasons
why actual outcome, events or results could differ materially from those anticipated in the forward-looking statements, except as required by law. You
should instead make or, if you are not qualified to do so, seek the assistance of qualified and professional counsel in making, an independent and
adequately substantiated assessment of us, our operations, current and future activities and commercial potential based on all available information about
us, as presented in financial reports, press releases and in other contexts, and about the business fields and markets in which we are active, as presented
in, inter alia, scientific and other publications (although we do not assume any responsibility for information about us obtained from third parties).

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Immunicum Establishing a unique immuno-oncology approach by developing allogeneic, off-the-shelf, cell-based therapies
Immunicum Corporate Overview

     Uniquely Positioned Backbone Immune Primer
         • Off-the-shelf allogeneic cell therapy as intratumoral immune primer against neoantigens
     Advanced Stage
        • Phase II study in RCC fully enrolled; top-line results Q3 2019
        • Excellent safety profile in over 90 patients in various solid tumors
        • Robust GMP manufacturing in place and commercial scale activities initiated
     Validated Approach
         • Global regulatory interactions with US IND in place, EU CTAs & ATMP Certification
         •                  collaboration/supply agreement for Phase II part of new study
     Growth Opportunity
        • Recent capital raise of $39 M at Nasdaq Stockholm with strong institutional investors
        • Well-positioned to achieve data-driven value-inflection points in next 12 months

     Experienced Team
        • Extensive experience in pharma, business development, CMC and Regulatory

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Immunicum Establishing a unique immuno-oncology approach by developing allogeneic, off-the-shelf, cell-based therapies
Immunicum: advanced pipeline in solid tumor indications

                  Product & Indication                  Combination                    Preclinical                   Phase I                   Phase II   Phase III

  Ilixadencel: an off-the-shelf cancer immune primer
  Immunicum’s lead product consists of allogeneic pro-inflammatory dendritic cells injected in the patient’s tumor to prime and activate the
  patient’s own immune system to recognize and attack the tumor.

  Kidney cancer                                    Kinase inhibitors                                                     top-line results Q3 2019

  Liver cancer                                     Kinase inhibitors

  Gastrointestinal stromal tumors                  Kinase inhibitors

  Head and neck cancer                             Checkpoint inhibitors

  Non-small cell lung cancer                       Checkpoint inhibitors

  Gastric cancer                                   Checkpoint inhibitors

  IMM-2: allogeneic dendritic cells with adenovirus coding for tumor antigens
  Immunicum’s proprietary adenovector can be used to deliver genes, coding for oncoviral antigens or neoantigens and immune-boosting
  factors, into allogeneic dendritic cells, to create a cancer vaccine with optimal immune priming capacity.

  IMM-3: optimized CAR-T expansion protocol for improved anti-cancer activity
  Immunicum’s CD70 platform uses our core expertise in dendritic cell biology to provide superior expansion of CAR-T cells with improved
  anti-tumor activity as well as higher resistance to oxidative stress and immunosuppressive factors in the solid tumor environment.

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Immunicum Establishing a unique immuno-oncology approach by developing allogeneic, off-the-shelf, cell-based therapies
Ilixadencel: a unique off-the-shelf immune primer

Cell based, off-the-shelf immunotherapy product
• Allogeneic cells from healthy donor leukapheresis
• GMP-production at German CMO
• Proprietary method with cocktail to create pro-inflammatory dendritic cells
                                                                       not a vaccine!
Intratumoral administration
• Applicable to all injectable solid tumors
• Using the tumor as the source of neoantigens as in situ vaccination
• Off-the-shelf approach inducing an individualized response

                         ILIXADENCEL PRODUCTION

                             Healthy
                        1x    donor
                             sample
                                                  100x   ilixadencel
                                                             doses                      50x   Patients
                                                                                              treated

                                                         3 YEAR SHELF-LIFE

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Immunicum Establishing a unique immuno-oncology approach by developing allogeneic, off-the-shelf, cell-based therapies
Ilixadencel: mechanism of action in the tumor
Recruits and activates the patient’s own immune cells to prime a cytotoxic Th1 response against the released neoantigens

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Immunicum Establishing a unique immuno-oncology approach by developing allogeneic, off-the-shelf, cell-based therapies
The immune primer positioning: starting the immune response

            immune primers                   immune enhancers          checkpoint inhibitors

 TLR/STING, oncolytic viruses, vaccines          IL-2, 4-1BB           PD-(L)1, TIM-3, LAG-3
              ilixadencel

       prime T cell population            expand T cell population   block tumor’s defenses

          “start the engine”                  “push the gas”           “release the brake”

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The immune primer landscape: from traditional vaccines to
neoantigen-based approaches

                                                         Immune primer/vaccine approach

  Tumor-associated antigens
                                              Neoantigens
                                         (tumor-specific antigens)
                                                                                             Neoantigens using tumor as source
     Traditional vaccines
 (e.g. Dendreon, Bavarian, Inovio)
                                      Ex vivo / autologous vaccines
                                     (e.g. Neon Tx, Gritstone, BioNTech)       TLR ligands (e.g. Idera)
          Challenges!                                                         STING ligands (e.g. Aduro)
                                                                            Oncolytic viruses (e.g. Viralytics)          ilixadencel
• Not tumor-specific                           Challenges!
                                     • One product per patient: time
                                       consuming and expensive                        Challenges!
                                                                           • Limited recruitment / activation     Recruits immune cells
                                                                                                                  Induces tumor cell death
                                                                                                                  Activates immune response

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The immune primer landscape: moving to more complete MoA
 Comparative approaches starting to add cytokines and chemokines to their MoA based on initial clinical findings

                                     First generation              Second generation             Third generation

                              TLR                            STING / RIG-I                TLR + Flt3L
    TLR, STING, RIG-I
                              Phase III                      Phase I                      Preclinical

                              OV GM-CSF                      OV + TNF⍺ IL-2               OV + IL-12 Flt3L CCL4
     Oncolytic viruses
                              Phase III                      Preclinical                  Preclinical

                              IL-12 plasmid                  IL-12 / cytokine cocktail    IL-12 + CXCL-9 ⍺CD3
          IL-12
                              Phase II                       Preclinical                  Preclinical

                                                              Cytokines (e.g. IL-12)
       ilixadencel                                      Chemokines (e.g. XCL-1, CXCL-9)                    Phase II
                                                               Alloreactive T cells

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Ilixadencel – RCC

Phase I/II Study Completed
Phase I/II RCC: intratumoral injection in kidney of metastatic
     patients results in tumor-specific CD8+ T cell in blood and tumor

                                                                                          RENAL CELL CARCINOMA (RCC)

                                                                                                                    S
                                                                                                             KIDNEY
                                                                                                                                     TUMOR

                                                                                                                                         Normal kidney tissue surrounding
                                                   Untreated tumor area (reference)               Treated tumor area                                                                          Metastasis
                                                                                                                                                treated tumor area

                                                   A reference slide demonstrating the   A massive infiltration of cancer specific       A clear absence of T cells outside of   A clear increased presence of CD8+ T
                                                   amount of T cells (black dots) in a      CD8+ T cells in the tumor after               the tumor site (similar to a healthy         cells at a distant metastasis
                                                           non-treated tumor.                   injection of ilixadencel.                tissue) supporting that the massive     demonstrates that the immune system
                                                                                                                                              infiltration is tumor-specific.       is also able to identify and target
                                                                                                                                                                                 cancer cells in other parts of the body.

Laurell et al., Journal for ImmunoTherapy of Cancer 2017

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Phase I/II RCC: overall survival in mRCC patients more than
tripled vs historical data

Historical median OS of 14-16 months with sunitinib in newly        Median OS of 48 months with ilixadencel
diagnosed mRCC patients (Heng 2009; Ko 2014; Mejean 2018)           (Laurell et al., J Immunother Cancer 2017)

                                                                                                                      Still alive

                                                                                                                      Start of TKI

0              10              20              30              40                 50                60           70

 Time (in months) from start of ilixadencel treatment (as of January 2018)

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Phase I/II case report: ilixadencel followed by sunitinib results
      in complete remission of brain and liver metastases

         • Poor prognosis patient with multiple brain, lung and liver metastases                   PRIOR TO TREATMENT                  6 MONTHS POST TREATMENT

         • Received sunitinib due to progression after ilixadencel and surgery
         • Complete response of all brain and liver metastases
         • 66 months after ilixadencel treatment patient is still alive (October 2018*)

         • Literature on RCC patients with brain metastases1:
                                                                                                                                        Complete response of the brain
                   • 0% response in brain metastases to sunitinib (0/16 patients)               Patient with brain metastases before
                                                                                                         sunitinib treatment
                                                                                                                                       metastases 6 months after start of
                                                                                                                                                   sunitinib
                   • 6.3 months overall survival in these 16 patients

         •     Potential combination synergy as sunitinib may block tumor’s defense against activated immune response
         •     Phase II study includes sunitinib for all patients after ilixadencel injections, versus sunitinib alone

* Later follow-up than included in survival graph
1) Chevreau et al., Clin Genitourin Cancer 2014

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Ilixadencel

 Backbone Immunotherapy for
Solid Tumors in Major Indications
Ilixadencel in combination: kinase and checkpoint inhibitors

           TYROSINE KINASE INHIBITORS (TKIs)                                         CHECKPOINT INHIBITORS (CPIs)

      Kidney                    Liver              Gastrointestinal       Head and Neck               Lung                    Gastric
      (RCC)                    (HCC)                   (GIST)               (HNSCC)                 (NSCLC)                  (GA/GEJ)

       Phase II study in RCC (MERECA) fully enrolled                      Phase Ib/II multi-indication study (ILIAD) now initiating

 •   Randomized controlled study in 88 patients in EU and US          •     Recent FDA approval to allow initiation of study in US
 •   Ilixadencel followed by sunitinib vs. sunitinib alone            •     Phase Ib study (n=21) with PD1 inhibitor pembrolizumab
 •   Q3 2019: top-line results on overall survival, tumor             •     Subsequent Phase II controlled studies per indication
     response, tumor infiltration, etc.
                                                                      •     Nov' 2018:                        collaboration for Phase II
                                                                      •     2019: initial safety and dosing results expected
     Phase I/II study in HCC completed; GIST ongoing
                                                                          Preclinical studies with CPIs and immune enhancers
 •   Jan’ 2019: publication of HCC results
                                                                      •     Oct’ 2018: poster with results at ESMO conference
 •   2019: top-line results in GIST expected
                                                                      •     2019: additional preclinical studies planned

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Ilixadencel: delivering program to pivotal stage of development

Preclinical: efficacy with checkpoint inhibitors

                                                   Clinical: controlled efficacy with standard-of-care

                                                   ongoing: MERECA Phase II, read-out Q3 2019
    Clinical: CD8+ T cells in tumor and blood

                                                   Clinical: efficacy with checkpoint inhibitors

                                                   ongoing: ILIAD Phase Ib/II, read-outs 2019-2020
Clinical: infiltration and effects in metastases

                                                   Manufacturing: commercial scale at global CMO
            Clinical: safety in over 90 patients   ongoing: process development with Hitachi
            Regulatory: studies in US and EU

        Manufacturing: clinical scale at CMO

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Financial snapshot: recent capital raise of $39 M (SEK 351 M)

• December 2018: Directed & Rights Issue with a total of $39 M (SEK 351 M) with strong institutional investors
• $41 M cash (SEK 393 M; Q1 2019) provides financing towards end 2021 across value-inflection points
• Proceeds used for clinical studies, manufacturing commercial scale activities and preclinical studies

                           F I N A N C I A L   I N F O R M A T I O N    M A J O R   S H A R E H O L D E R S ( A p r i l )

                                                                                       Shareholder                %
                                                                        Avanza Pension                            8,97%
                            Nasdaq Stockholm: IMMU.ST                   Nordnet Pension Insurance                 5,73%
                            Market cap:         $75 M / SEK 726 M
                                                                        Fourth Swedish National Pension Fund       4,88%
                            Price (9-May-2019): $0.83 / 8 SEK           Gladiator                                  4,06%
                            Shares:             92,257,531              Martin Lindström                           3,62%
                                                                        Holger Blomstrand Byggnads AB              3,23%

                            Cash (31-03-2019): $41 M / SEK 393 M        Second Swedish National Pension Fund       2,71%
                                                                        Skandinaviska Enskilda Banken S.A          2,63%
                            Raised to date:     $92 M / SEK 826 M       Nordic Cross Asset Management              2,60%
                            Runway:             towards end 2021        BNP Paribas Sec Serv Luxembourg            1,95%
                                                                        BNP Paribas Asset Management               1,95%
                                                                        Theodor Jeansson                           1,73%

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Key value-inflection points in next 12 months

       SEK 351M ($39M)                                  Phase II RCC MERECA
       raised on Nasdaq                                  study top-line results
           Stockholm                                      on overall survival

2018                   2019                                                                             2020
       Q4                     Q1            Q2                      Q3                      Q4                 Q1

   Merck KGaA &                                  Phase I/II GIST
Pfizer collaboration                             top-line results

                Phase Ib/II ILIAD study                                   Phase Ib/II ILIAD study
               with checkpoint inhibitors                              with checkpoint inhibitors
                     First Patient In                               initial safety and dosing results

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Immunicum’s market: Immuno-Oncology

     • Immuno-Oncology global market size expected to reach $76 billion in 20221

     • Big Pharma racing to find combination therapies with their in-house checkpoint inhibitors, including BMS,
       Merck, and J&J with recent high-value transactions

Source: (1) Radiant Insights - Global Cancer Immunotherapies Market to 2022, 2016. (2) Financial Times 29 May 2015

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Management team experienced in drug & business development (1/2)

                                          -   Carlos de Sousa is a medical doctor by training, having earned his degree at School of Medicine, University of Lisbon and
      Carlos de Sousa                         holds an Executive MBA from the Stern School of Business, New York University.
      Chief Executive Officer
                                          -   Dr. de Sousa has more than 25 years of senior level experience in the global pharmaceutical and biotech industry, including
      M.D., Executive MBA                     business development, mergers & acquisitions, global marketing and clinical development.
                                          -   Prior to joining Immunicum, Dr. de Sousa held senior positions at Nycomed/Takeda, Pfizer, Novartis, BBB Therapeutics,
                                              Newron Pharmaceuticals and, most recently, as Chief Business Officer at Zealand Pharma in Denmark.

                                          -   Michaela Gertz holds a MSc in Business and Economics from Uppsala University including a course of study at the
      Michaela Gertz                          Katholieke Universiteit in Leuven, Belgium.
      Chief Financial Officer
                                          -   Ms. Gertz most recently was CFO & Investor Relations Manager at PledPharma AB, a drug development company based in
      MSc. in Business and                    Stockholm. She was instrumental in PledPharma’s IPO in 2011 and subsequent fund-raising efforts.
      Economics
                                          -   Prior to that, Ms. Gertz spent three years as Head of Investor Relations and Financing at Accelerator Nordic AB. Before
                                              joining the life sciences industry, Ms. Gertz worked in finance and private equity at ITP Invest AB and Handelsbanken.

      Alex Karlsson-Parra                 -   Adjunct Professor Karlsson-Parra has over 20 years of experience working in the field of transplantation immunology and is
      Founder, Chief Scientific Officer       former chairman of the Swedish Expert Group for Clinical Immunology.
      M.D., Ph.D. Adjunct Professor in    -   He was awarded the Athena Prize, the Swedish healthcare’s most prestigious award for clinical research, in 2014.
      Clinical Immunology, Uppsala
      University                          -   He was formerly Associate Professor and chief physician at the Department of Clinical Immunology at Sahlgrenska University
                                              Hospital, Gothenburg.

                                          -   Peter Suenaert is gastroenterologist – oncologist by training (Leuven University, Belgium, McGill University, Canada, Institute
      Peter Suenaert                          Gustave-Roussy, France) and holds a PhD in gut barrier function related to inflammatory bowel diseases from Leuven
      Chief Medical Officer                   University.
      M.D., Ph.D. Digestive               -   Prior to joining Immunicum Dr. Suenaert served as Global Clinical Program Lead of Glenmark Pharmaceuticals for the oncology
      Oncologist                              unit (immune oncology assets) from start-up stage to being fully operational phase I/II protocol development.

                                          -   Dr. Suenaert has held several leading positions within global clinical development and research e.g. a Clinical Research
                                              Development leader in global early cancer immunotherapeutics development at GlaxoSmithKline Vaccine in Belgium.

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Management team experienced in drug & business development (2/2)

      Sharon Longhurst                -   Sharon Longhurst holds a Ph.D. in Virology from the University of Warwick, UK.
      Head of CMC                     -   Dr. Longhurst has more than 15 years of experience in leading CMC efforts in small and medium sized organizations.
      Ph.D. in Virology               -   Prior to joining Immunicum, she was Senior CMC Manager at Akari Therapeutics, where she was responsible for all aspects
                                          of CMC. Before Akari, she spent 5 years as Principal Consultant of CMC at Parexel Consulting, and 6 years as
                                          Pharmaceutical Assessor at MHRA in London.

                                      -   Margareth Jorvid holds an MSc. Pharm from Uppsala University, Sweden, a MSc MTRA from Cranfield University, UK, and
      Margareth Jorvid                    an MBA from Stockholm School of Economics, Sweden.
      Head of Regulatory and QA
                                      -   Ms. Jorvid has over 30 years of Regulatory Affairs experience and has worked at the regulatory side at the Medical Products
                                          Agency (MPA) in Sweden, and in large and small pharmaceutical companies such as Roussel Nordiska and Neopharma.
      MSc. in Pharmacology, MBA       -   Since 2006, she is consultant in regulatory affairs and quality assurance as CEO of Methra Uppsala AB, LSM group, and is
                                          fellow and Honorary Life Member of TOPRA - The Organisation for Professionals in Regulatory Affairs.

                                      -   Sijme Zeilemaker holds an MSc. in Biomedical Sciences - Management from Leiden University, the Netherlands, which
      Sijme Zeilemaker                    included an exchange program with Karolinska Institutet, Sweden.
      Senior Director Business
      Development                     -   Mr. Zeilemaker had various business development positions at preclinical and clinical oncology biotech companies, being
                                          responsible for pharma/biotech partnering, licensing technologies, non-dilutive funding, and corporate communication.
      MSc. in Biomedical Sciences -
      Management                      -   He was formerly Director Business Development at InteRNA Technologies, Head of Business at 2-BBB Medicines and
                                          Business Development Manager at to-BBB technologies in the Netherlands.

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Immunicum: corporate highlights

             Unique Positioning              Advanced Stage

            Innovative immune primer        Phase II fully enrolled

            Off-the-shelf cell therapy      Safety in >90 patients

               Backbone therapy             Robust manufacturing

             Experienced Team              Growth Opportunity

               Pharma & Biotech           Immuno-Oncology market

                Founder as CSO             SEK 351 M capital raise

               CMC & Regulatory          Value-inflection data in 2019

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Immunicum
Establishing a unique immuno-oncology approach
by developing allogeneic, off-the-shelf, cell-based
therapies
Strong patent protection until at least 2031
Patent family                  Country                 Filing Date        Expir. date                           Title                                         Status
                      BE, BR, CH, CN, DE, DK,
                      ES, FR, GB, HU, IE, IT, JP,                         2031-02-10          Improved composition for inhibiting       Granted: all other
Ilixadencel                                           2011-02-10
                      KR, NL, PL, RU, SE, SI, TR,                       2031-08-16 (US)       tumor cell proliferation                  Pending: BR
                      US
                      AU, BE, BR, CA, CH, CN,                                                                                           Granted: BE, CH, DE, DK, ES, FR, GB,
                      DE, DK, ES, FR, GB, HU,                             2033-12-18          Co-differentiation of monocytes from      HU, IE, IT, MX, NL, US
Production                                            2013-12-18
                      IN, IE, IT, ID, JP, KR, MX,                       2034-01-28 (US)       allogeneic donors
                      NL, PL, RU, SE, SI, TR, US                                                                                        Pending: all other
                      CH, DE, DK, ES, FR, GB,       2002-06-06 (SE)       2022-06-06          New method and composition for
IMM-2                                                                                                                                   Granted: all
                      HU, IE, IT, NL, SE, SI, US      2003-06-05        2023-12-19 (US)       producing cellular allogenic vaccine
                                                                                              Hexon tat-ptd modified adenovirus and
IMM-2 adenovirus      US                              2013-05-13          2033-05-33                                                    Granted: US
                                                                                              uses thereof
                                                     2017-09-20 (EP)                          Improved allogeneic dendritic cells for
IMM-2                 EPO, WO                                               ~2038                                                       Pending
                                                    2018-09-19 (WO)                           use in cancer treatment
                                                                                              Method for proliferation of
IMM-3                 CN, EPO, HK, JP, US             2010-10-13          2030-10-13                                                    Granted: CN, HK, JP, US
                                                                                              antigen-specific T cells
IMM-3 antiviral       EPO, US                         2012-04-12          2032-04-12          Method for priming of T cells             Granted: US, EPO
                                                                                              Method for proliferation of
IMM-3                 CN, EPO, JP, US                 2012-04-12          2032-04-12                                                    Granted: CN, US, JP
                                                                                              antigen-specific T cells

 Additional potential protection
 ü    Additional 7-10 years of protection for Orphan Drug designation possible depending on regulatory authority
 ü    Additional 5 years of protection possible through Supplementary Protection Certificate (SPC)
 ü    Manufacturing process and regulatory landscape increase complexity and barriers to entry

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Ilixadencel as backbone therapy in the cancer immunity cycle:
“pushing the gas” to turn cold tumors into hot tumors for immunotherapy

                                                                                  4         Trafficking of CD8+ “killer” T cells to cancer tissue

        Priming and activation of CD8+ T cell
    3                                                            BL                                          5       Infiltration of T cells into cancer tissue
        immune response to neoantigens                             OO
                                                LY                      D
                                                  MP                        VE
                                                    HN                           SS
                                                      OD                              EL
                                                        E

                                                                                              OR
                                                                                           TUM
        Transport of neoantigens by                         ILIXADENCEL
    2                                                         INJECTION                                          6      Recognition of cancer cells by T cells
        dendritic cells to lymph nodes

        Release of tumor neoantigens and                                                                Killing of cancer cells
    1                                                                                              7
        recruitment of dendritic cells

                         PUSH THE GAS:                                                                RELEASE THE BRAKE:
                  ACTIVATE THE IMMUNE SYSTEM                                                   BLOCK CANCER IMMUNE SUPPRESSION
                                                                                                   and/or KILL CANCER CELLS

             Immunicum’s ilixadencel primes and                                            checkpoint inhibitors (Keytruda®/Opdivo®)
               activates the immune system to                                                tyrosine kinase inhibitors (sunitinib)
                recognize and find cancer cells                                                 chemotherapies (gemcitabine)

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