Circio Holding Asa · OSL:CRNA
Circio Holding Asa — Investor Presentation (January 2023)
30 slides from Circio Holding Asa's investor presentation, January 2023
Slide 1: Company overview January 2023
Company overview January 2023 1
Slide 2: Important notice and disclaimer
Important notice and disclaimer This report contains certain forward-looking statements based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on the results of operations and the financial condition
Slide 3: Targovax executive summary
Targovax executive summary ON COS-102: oncolytic immunotherapy with demonstrated clinical efficacy and excellent safety profile in multiple solid tumors and treatment combinations H ighly competitive response rate: 35% ORR in anti-pd-1 resistant melanoma, responses in non-injected lesions and deep m
Slide 4: Strong, international senior management team with a versatile range of backgrounds
Strong, international senior management team with a versatile range of backgrounds Dr Erik D Wiklund Dr Lubor Gaal Dr Lone Ottesen Dr Victor Levitsky Dr Thomas Hansen Mr Ola Melin Dr Ingunn M Lindvig Chief Executive Chief Financial Chief Medical Chief Scientific VP & Head of VP & Head of VP & Head o
Slide 5: Targovax development pipeline
Targovax development pipeline Preclinical Clinical Product candidate Discovery IND- Phase 1 Phase 2 Phase 3 / Milestones enabling pivotal PD- 1 Resistant Melanoma 1H 2023 Re-challenge combination w/aPD-1 & CTLA-4 Initiation of phase 2 trial (USA) ONCOS- 102 Mesothelioma 1H 2023 Combination w/Standar
Slide 6: Lead clinical program: ONCOS-102
1 Lead clinical program: ONCOS-102 i. Melanoma ii. Mesothelioma 6
Slide 7: ONCOS-102 is designed to drive strong immune activation and resensitize tumors to checkpoint inhibitors
ONCOS-102 is designed to drive strong immune activation and resensitize tumors to checkpoint inhibitors ONCOS- 102 is an adenovirus that… Attracts immune cells to the tumor Reverses immuno-suppressive defence mechanisms in the tumor Primes anti-cancer T-cell responses Delivers an immune stimulatory
Slide 8: PD-1 resistant melanoma - major and growing unmet medical need
Melanoma PD-1 resistant melanoma - major and growing unmet medical need Total ~50,000 patients per year diagnosed with Incidence unresectable advanced malignant melanoma globally ~50% of cases become PD-1 resistant PD- 1 resistance Total ~25,000 patients per year Estimated 10,000 – 20,000 patients p
Slide 9: ORR of 35% in PD-1 resistant melanoma
Melanoma ONCOS-102 achieved a highly competitive ORR of 35%* in PD-1 resistant melanoma CR PR 35% ORR ONCOS- 102 5% 30% (7/20 pts.) 35% ORR BNT111 0% 35% (6/17 pts.) 29% ORR RP1 13% 16% (18/61 pts.) Anti- PD1 23% ORR Vidutolimod 7% 16% retreatment (23/98 pts.) 21% ORR Lenvatinib 3% 18% (22/103 pts.)
Slide 10: Tumor specific activity: multiple examples of systemic anti-tumor effect
Melanoma Tumor specific activity: multiple examples of systemic anti-tumor effect Response in individual tumors % change from baseline; injected and non-injected lesions Observed systemic Injected (n=16)1 effect: Non-injected (n=36) Part 1 o 12 of 36 (33%) non-injected Part 2 target lesions reduced
Slide 11: ONCOS-102 drives strong and consistent immune responses, particularly in responding patients
Melanoma ONCOS-102 drives strong and consistent immune responses, particularly in responding patients CD8+ T- cell tumor infiltration CD8+ T- cell infiltration increased over time Tumor biopsy IHC, patient case example in patients with clinical benefit (CR+PR+SD) p = 0.01 Progression on 3x ONCOS-102
Slide 12: Strong rationale for combining ONCOS-102 with both PD-1 and CTLA-4 checkpoint inhibitors
Melanoma Strong rationale for combining ONCOS-102 with both PD-1 and CTLA-4 checkpoint inhibitors Reverse immuno- CTLA-4 blockade depletes inhibitory regulatory suppression T-cells both within the tumor and systemically Enhance anti- CTLA-4 blockade enhances the priming of tumor T-cell tumor-specifi
Slide 13: Next step ONCOS-102: multi-cohort Phase 2 trial with PD-1 and CTLA-4 checkpoint inhibitor combination
Melanoma Next step ONCOS-102: multi-cohort Phase 2 trial with PD-1 and CTLA-4 checkpoint inhibitor combination Part 1 – higher dose exploration run-in Part 2 – multi-cohort extension 1 ONCOS- 102 2 ONCOS- 102 + monotherapy Expand to n=37 balstilimab high dose1 Confirm safety Randomize 3 Select dose
Slide 14: The phase 2 trial is designed to enable future out-licensing and address regulatory requirements
Melanoma The phase 2 trial is designed to enable future out- licensing and address regulatory requirements Opportunity to achieve best- in- class data in PD-1 resistant melanoma setting Differentiated combinations vs. competitors, with strong scientific and strategic rationale Design and size
Slide 15: Malignant pleural mesothelioma - high unmet medical need
Mesothelioma Malignant pleural mesothelioma - high unmet medical Surgery Radiotherapy Only 10% of patients suitable Rarely effective due to tumor for resection shape Often diagnosed too Hard to focus radiation late for surgery Mainly Technically challenging palliative care Chemotherapy Immunotherapy
Slide 16: ONCOS-102 has demonstrated strong survival outcomes in first line mesothelioma
Mesothelioma Additional opportunity: ONCOS-102 has demonstrated strong survival outcomes in first line mesothelioma mPFS months 11 ONCOS-102 + chemo SoC has showed the best mOS data reported to date Targovax experimental 10 ONCOS-102+Pem/cis Pem/cis (or carbo) Checkpoint trials 9 Targovax chemo 8 on
Slide 17: Circular RNA pipeline program
2 Circular RNA pipeline program 17
Slide 18: RNA is a highly promising therapeutic class, however several challenges remain unsolved
RNA is a highly promising therapeutic class, however several challenges remain unsolved RNA is chemically unstable – Targovax delivery platform can help mRNA vaccines have required overcome these challenges: heavy modifications o Expressing RNA from a DNA-based vector solves the stability issue Effi
Slide 19: Targovax is a pioneer in the field of circular RNA (circRNA)
Targovax is a pioneer in the field of circular RNA (circRNA) The circRNA discoverers work for Targovax Dr Thomas Hansen Dr Erik D Wiklund 19
Slide 20: circRNA - a toolbox to create a novel class of medicines
circRNA - a toolbox to create a novel class of medicines Maximize payload expression Extra-cellular trafficking Circular RNA is resistant to exonuclease degradation, leading to vastly increased half-life Onco-microRNA sponging Immune response booster TLR PRR 20
Slide 21: circAde – Targovax's system for circRNA delivery to solid tumors
circAde – Targovax’s system for circRNA delivery to solid tumors circAde vectors 2023 objectives for the circAde program: o Establish in vivo proof-of-concept for circAde delivered circRNA concept Circular RNA o Validate multiple circAde vector types in oncology and vaccine therapeutic areas Gene th
Slide 22: Targovax's circAde offers important advantages
Targovax´s circAde offers important advantages Enhanced Does not Suitable Delivery Existing Delivery intra-cellular require vaccination to solid GMP manu- to liver stability packaging platform tumors facturing circAde vector approach Synthetic circRNA Synthetic mRNA o Targovax has only approach with
Slide 23: Technical proof-of-concept established for circAde
Technical proof-of-concept established for circAde Functional circAde vector established Highly effective circRNA design identified Payload expressed from vector-encoded circRNA Plasmid-expressed circRNA, transfected cells Insertion Vector Protein expression strategy function V1 V2 V4 Rep 2 Rep 2 Re
Slide 24: Summary of circRNA data
Summary of circRNA data Functional vector design established Superior circRNA design identified Extended circRNA half-life confirmed Enhanced and prolonged circRNA protein expression vs. mRNA In vivo PoC experiments being run in 1H 2023 24
Slide 25: Initial focus on oncology applications, with plans to expand platform into vaccines and rare disease
Initial focus on oncology applications, with plans to expand platform into vaccines and rare disease Approach 1 Activate validated immuno- stimulatory targets that face Core initial Oncology systemic toxicity issues focus for Solid tumors Modulate key cancer signalling and metabolic pathways in-hous
Slide 26: Targovax has a unique edge in the emerging circRNA field
Targovax has a unique edge in the emerging circRNA field World- leading experts in- house with over 10 years circRNA experience Led by circRNA pionéer Dr. Thomas Hansen Unique circAde vector system for circRNA delivery to solid tumors Technical PoC established, vector turns cancer cells into circRNA
Slide 27: Outlook
4 Outlook 27
Slide 28: Strategy with multiple value inflection points in the short- to mid-term
Strategy with multiple value inflection points in the short- to mid-term Pillar Value creation opportunities Opportunity to become best- in- class in PD- 1 resistant melanoma Data from differentiated combination with botensilimab +/- PD-1 ONCOS-102 Phase 2 designed and sized to be attractive for big
Slide 29: Financial snapshot
Financial snapshot Key figures Shareholder base Net cash flow in 3Q - 30 -3 Shareholder Estimated ownership1 Shares million Ownership NOK million USD million HealthCap 12.4 6.6 % Avanza Bank AB (nom.) 6.3 3.3 % Cash at end of 3Q 96 9.6 Goldman Sachs Int. (nom.) Bækkelaget Holding AS 5.2 5.1 2.8 % 2.
Slide 30: Want to learn more?
Want to learn more? CEO Dr. Erik Digman Wiklund Contact erik.wiklund@targovax.com www.targovax.com 30
Circio Holding — Investor Presentation (January 2023) on 6ix