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CHIMERIC THERAPEUTICS LIMITED — Investor Presentation 2021
Nov 30, 2021
64648_rns_2021-11-30_e5936114-3021-44fa-ba93-55c4b63ec92b.pdf
Investor Presentation
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THE ASX LEADER IN CELL THERAPY
TRANSFORMATIVE PORTFOLIO EXPANSION
CORE-NK Platform
Transformative Portfolio Expansion
A platform technology that can be leveraged to develop multiple new therapies
Broadens Chimeric’s reach into 10+ disease areas including blood cancers and solid tumours
Triples Chimeric’s pipeline adding 5 new cell therapy assets
Ability to further leverage the platform through partnerships or licensing
Extends Chimeric’s clinical development program with 5 new clinical trials by 2023
Propels Chimeric forward as the ASX leader in cell therapy and as an emerging global cell therapy company
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THE MOST ROBUST AND ADVANCED PORTFOLIO AND PIPELINE IN AUSTRALIA
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Unique Assets 8 Clinical Trials by 2023 10+ Disease Areas
CHIMERIC PIPELINE DEVELOPMENT STRATEGY
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2 novel individualized (autologous) CAR T cell therapies
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Exploration of opportunities with alternative cell types and cell sources
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Novel Designs
T Cells
NK Cells
Individualized
(autologous)
CLTX CLTX CDH17
Phase 1 CAR T
CAR T CAR T
ongoing in
brain cancer Phase 1 Planned
Phase 1 Ongoing Off the Shelf
2022
(allogeneic)
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WHY NATURAL KILLER (NK) CELLS?
Natural killer cells are superior immune cells
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Natural Killer (NK) Cell
Natural killer cells are part of our immune system and have a natural ability to identify and kill tumour cells. (they’re named for this “natural” killing ability) Natural killer cells are also able to produce cytokines that recruit and activate the immune system to mount an additional response to kill tumour cells.
Natural killer cells also have fail-safe mechanisms that prevent the killing of healthy cells making them ideal for off the shelf platforms.
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WHY OFF THE SHELF?
Off the shelf therapies offer benefits and convenience to individualized therapies
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Healthier Scalable Rapidly Ability to
starting manufacturing available, reach more
material with reduced costs off the shelf patients
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Early Stage, Off the Shelf, NK Cell Platforms are Driving Significant Value
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nt Value |
nt Value |
nt Value |
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|---|---|---|---|---|
| Ph. 1 non-engineered NK cell platform Preclinical CAR NK products (2) $30M USD upfront + up to $1.8 B in milestones and royalties for to three CAR NK cell therapies targeting solid tumours Collaboration January 2021 |
Preclinical non-engineered NK cell platform $45M USD + undisclosed milestones and royaltiesfor up to four NK cell therapies Collaboration June 2021 |
Undisclosed upfront + $2.3B in milestones and royaltiesfor up to three CAR NK cell therapies Preclinical non-engineered NK cell platform Collaboration June 2021 |
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Chimeric Therapeutics Off the Shelf, Natural Killer Cell Platform CORE-NK Platform Clinically Validated, Off the Shelf, Robust, Enhanced, Natural Killer Cell Platform
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INVESTMENT HIGHLIGHTS
CORE-NK PLATFORM
Clinically Validated, Off the Shelf, Robust, Enhanced, Natural Killer Cell Platform
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§ An off the shelf, natural killer cell platform technology that will be leveraged to develop multiple new therapies
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§ Clinical validation of the platform with a complete Phase 1 clinical trial in blood cancers and solid tumours
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§ Platform enables near-term development of four additional Chimeric therapies for solid tumours and blood cancers
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§ Synergistic with existing Chimeric assets, providing the ideal foundation to fast-forward development of CLTX CAR-NK and CDH17 CAR-NK therapies
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§ Further ability to leverage the platform to build additional new therapies through partnerships or licensing
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§ Phase 1 trials for new assets planned to begin in 2023
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§ Off the shelf therapies and NK cells are highly attractive for investment and partnering
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§ Attractive option terms with a planned research collaboration with Case Western
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THE CORE-NK PLATFORM A Novel Strategy to Enhance NK Cells Natural Abilities
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David
WALD, MD, PhD
Associate Professor, Department
of Pathology, School of Medicine
Member, Immune Oncology Program,
Case Comprehensive Cancer Center,
Associate Director for Basic Research, University
Hospitals, Wesley Center for Immunotherapy
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Dr David Wald is a clinician-scientist at Case Western Reserve University in Cleveland, Ohio.
With an interest in cancer drug development Dr Wald has focused his research on using natural killer cells to eliminate colorectal cancer and acute myeloid leukemia.
Dr Wald developed a novel strategy to expand and activate NK cells ex vivo using a proprietary feeder cell line made him a CTP award recipient in 2018.
This engineered NK platform was specifically designed to overcome the hurdles often associated with NK cell development, including the ability to produce large numbers of highly active universal donor NK cells that maintain their activity once they’re in the body.
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CORE-NK Platform Cells Enhancing the Natural Cancer-Fighting Power of NK cells
Natural Killer (NK) Cell
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Natural killer cells are found in our bodies normally and are able to recognize and kill cancer cells- but are not robust and active enough to overcome cancer as it grows
CORE-NK Platform Cell
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CORE-NK cells are made by activating and expanding natural killer cells to make them more active and robust in large quantities
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CORE-NK PLATFORM PHASE 1 CLINICAL TRIAL
PATIENT ELIGIBILITY
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BLOOD CANCERS
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Acute Myeloid Leukemia Plasma Cell Myeloma Myelodysplastic Syndromes Acute Lymphoblastic Leukemia Chronic Myeloid Leukemia Chronic Lymphocytic Leukemia Myeloproliferative Syndromes Non-Hodgkin Lymphoma Hodgkin Lymphoma
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SOLID TUMOURS
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Adenocarcinoma of the Rectum Rhabdomyosarcoma Soft Tissue Sarcoma Ewing’s Sarcoma Colon Cancer
Phase 1 Clinical Trial Dr David Wald, Case Comprehensive Cancer Center Study Initiation : May 2018 Primary Completion : June 2021 Estimated Study Completion : May 2022
PHASE 1 DOSE ESCALATION
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CORE-NK PLATFORM (CHM 0201) PHASE 1 CLINICAL TRIAL COMPLETE
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PRIMARY COMPLETION 11 PATIENTS ENROLLED 9 PATIENTS DOSED
JUNE 2021
SOLID TUMOURS COMPLETION OF ALL
DATA CURRENTLY PENDING AND BLOOD CANCERS 3 DOSE LEVELS
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DATA ANTICIPATED 2022
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CORE-NK PLATFORM (CHM 0201) WHAT DO WE DO WITH IT?
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CHM 0 201
CORE-NK
Platform
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1.
2.
3.
Next Generation CORE-NK Platform
Further enhance the CORE-NK platform with next generation technologies for development as a combination therapy
CAR-NK Products
Fast-forward development of supercharged CAR NK products using our CLTX and CDH17 chimeric antigen receptors
Leverage the CORE-NK Platform Identify collaborations or licensing opportunities to further expand the utilization of the CORE-NK platform
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CORE-NK PLATFORM (CHM 0201) WHAT DO WE DO WITH IT?
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CHM 0 201
CORE-NK
Platform
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1. Next Generation CORE-NK Platform
2. CAR-NK Products 3. Leverage the CORE-NK Platform
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1.
NEXT GENERATION CORE-NK Platform
Further enhancing the cancer-fighting power of the CORE-NK platform cells
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CHM 0201
CORE-NK
Platform
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Next Generation Enhancements
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CHM 0301
Next Gen
CORE-NK
Platform
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CHM 0301 NEXT GENERATION CORE-NK Platform Development in Blood Cancers as Combination Therapy
Acute Myeloid Leukemia
B Cell Malignancies
Multiple Myeloma
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Cancer of the bone marrow and blood that generally progresses at a rapid pace
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Incidence 4.3/ 100,000
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2[nd] most common type of leukemia with ~100,000 new cases globally each year
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5 year survival 24%
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Type of non-Hodgkin lymphoma that originates in the B cells
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• Incidence 8/ 100,000
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• 85% of all non-Hodgkin lymphomas; includes diffuse large B cell lymphoma & follicular lymphoma
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• 5 year survival ~69%
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Cancer of the plasma cells in the bone marrow
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Blood cancer of cells found in the bone marrow, specifically the “plasma cells.”
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• Incidence: 5/ 100,000
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• 5 year survival ~54%
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2.
CAR-NK PRODUCTS
HOW DO YOU TURN A CORE-NK CELL INTO A CAR-NK?
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CORE-NK CAR-NK Platform Cell Cell CAR-NK The Chimeric products are Antigen made by Receptor then inserting Insertion of Chimeric gets expressed Chimeric on the cell Antigen Antigen surface Receptors Receptor supercharging (CARs) into the the cells cancer CORE-NK fighting abilities platform cells
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Expression of Chimeric Antigen Receptors
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CHIMERIC SUPERCHARGED CAR-NK PRODUCTS LEVERAGING OUR CHIMERIC ANTIGEN RECEPTORS
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CLTX
CAR
CDH17
CAR
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CHM 1301 CLTX CAR-NK
CHM 2301 CDH17 CAR-NK
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TRANSFORMATIVE PORTFOLIO DEVELOPMENT A DIVERSIFIED PIPELINE WITH CUTTING EDGE INNOVATION
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Novel Design
NK Cells
T Cells
Autologous Allogeneic
(personal) (off-the-shelf)
CHM 0201 CHM 0301 CHM 1301 CHM 2301 CHM 3301
CHM 1101 CHM 2101
(CORE-NK (Next Gen. (CLTX (CDH17 (Undisclosed
(CLTX CAR T) (CDH17CAR T) CORE-NK
Platform) CAR-NK) CAR-NK) CAR-NK)
Platform)
Phase 1 Phase 1
Phase 1
ongoing planned 2022 Ph. 1 Planned Ph.1 Planned Ph.1 Planned Ph.1 Planned
Complete
2023 2023 2023 2023
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3.
LEVERAGE THE CORE-NK PLATFORM IDENTIFY COLLABORATION AND LICENSING OPPORTUNITIES
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Development of 4 CAR NK / CAR T $50M upfront +$50M equity investment + products $3B milestones + double digit royalties $30M upfront + Development of 3 CAR NK products $612/ per CAR NK; $1.8B potential Undisclosed upfront + Development of 2 CAR iNKT products $875M USD milestones + royalties Development of 4 CAR NK products Undisclosed upfront, milestones and royalties Non-engineered NK cells Acquired by Sanofi $308 M EUROS
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CORE-NK PLATFORM DEVELOPMENT PLAN 4 NEW CLINICAL TRIALS BY 2023
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ü • • CORE-NK platform Phase 1 Phase 1 clinical trial: Next Development of CLTX CAR-NK
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clinical trial completed at and CDH17 CAR-NK products generation CORE-NK platform Case Western • Phase 1 CAR NK clinical trial
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• Initiate development of the • Identification of 3[rd] undisclosed (CLTX CAR-NK, CDH17 CARNext Generation CORE-NK CAR for development NK and undisclosed CAR-NK) platform
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2021 2022 2023
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ESTABLISHING VALUE IN THE NK DEVELOPMENT FIELD
| Planned Time to Phase 1 Clinical Trial | Planned Time to Phase 1 Clinical Trial | Planned Time to Phase 1 Clinical Trial | Planned Time to Phase 1 Clinical Trial | Planned Time to Phase 1 Clinical Trial |
|---|---|---|---|---|
| Company | Market Cap | 2021 | 2022 | 2023 |
| $90M AUS | CHM 0301(Next Generation CO CHM 0201 (CORE- NK) CHM 1301 (CLTX CAR-NK) CHM 2301 (CDH17 CAR-NK) CHM 3301(Undisclosed CAR-N |
RE-NK) K) |
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| $948M USD | CD19 CD19+ CD79 CD133+ EGFR |
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| $5.0B USD | CD19 BCMA MICA A/B B7H3 |
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| $851M USD | Enhanced NK Cells HER2 |
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| $540M USD | NKG2D CD19 CD70 |
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| $637M USD | Agent 797 BCMA Stromal Target |
THE MOST EXPERIENCED CELL THERAPY TEAM IN AUSTRALIA GLOBAL EXPERTS IN CELL THERAPY DEVELOPMENT & COMMERCIALIZATION
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Jennifer
CHOW
Chief Operating
Officer
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KITE PHARMA Head of Global Marketing, Commercial Operations and Analytics
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CELGENE Global Cell Therapy Commercial Lead
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Dr Syed
RIZVI
Chief Medical Officer
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LEGEND BIOTECH
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VP, Clinical Development and Medical Affairs
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CELGENE
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Global Cell Therapy Medical Affairs Lead
Development of over CELL 25 THERAPIES including Dr Eliot Dr Li BOURK REN OF THE VP, Business and VP, Technical FDA-APPROVED 4/5 Corporate Development Operations CAR T CELL THERAPIES • KITE PHARMA • BMS Head of Early Global Manufacturing, Commercial Development Cell Therapy Development and Operations
• CELGENE Global Cell Therapy • CELGENE Commercial Strategy and CAR T CMC and Next Generation Platforms Technology Development
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an Emerging Global Cell Therapy Company
A clinically validated, off the shelf NK platform technology that can be leveraged to develop multiple new therapies
Studied in a phase 1 clinical trial completed in June 2021 in both solid tumours and blood cancers
Enables the accelerated development of 4 Chimeric next generation, off the shelf NK and CAR-NK products
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Cutting edge cell therapy portfolio with 7 innovative assets using alternative cell types and sources
Advanced clinical development with 4 clinical trials by 2022 and 8 clinical programs by 2023
Broad development in 10+ disease areas including solid tumours and blood cancers
Additional opportunity for further development through internal development and/ or partnerships
Propels Chimeric forward as the ASX leader in cell therapy and as an emerging global cell therapy company
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