Calidi Biotherapeutics, Inc. · AMEX:CLDI
Calidi Biotherapeutics — Investor Presentation (January 2024)
33 slides from Calidi Biotherapeutics's investor presentation, January 2024
Slide 1: Corporate Presentation
Corporate Presentation Arming the Immune System to Kill Cancer with a New Generation of Targeted Immunotherapies January 2024 www.calidibio.com
Slide 2: Forward-Looking Statements and Legal Disclaimer
Forward-Looking Statements and Legal Disclaimer This presentation may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “ex
Slide 3: Investment Highlights
Investment Highlights Calidi Biotherapeutics is a clinical-stage biotechnology company developing a new generation of targeted immunotherapies CLD-101: Neural stem cell (NSC) product candidates loaded with oncolytic adenovirus 1 Two Differentiated Stem Cell Platforms CLD-201: Allogeneic Adipose-deri
Slide 4: Calidi Overcomes the Obstacles to Oncolytic Viral Therapy
Calidi Overcomes the Obstacles to Oncolytic Viral Therapy Challenges with Naked OV Therapy Calidi’s Solution Unprotected Oncolytic Virus Allogeneic Oncolytic Virus-Loaded Stem Cells Active Rapid inactivation Stem cell loaded with Oncolytic Inactivated Oncolytic Viruses Stem cell protects by immune V
Slide 5: From Autologous to Allogeneic, developing a Universal Cancer therapy
From Autologous to Allogeneic, developing a Universal Cancer therapy Prior safety study was conducted using autologous stem cells Future studies will be conducted using allogeneic stem cells The Past The Present and Future Autologous Allogeneic Immune Rejection Stealth Low immunogenicity (Stealth) C
Slide 6: Calidi’s Platform Advantages
Calidi’s Platform Advantages Cell Protected: Oncolytic Virus Adenovirus Vaccinia Virus Herpes Virus Vaccinia Virus Herpes Virus Adenovirus Vaccinia Virus Platform Herpes Virus Adenovirus Engineered Virus ✔ ✔ ✔ ✔ ✔ ✔ ✔ Reduced viral elimination by the immune system ✔ X X X X X X Virally-encoded thera
Slide 7: Rapidly Growing OV Market With High Unmet Medical Needs
Rapidly Growing OV Market With High Unmet Medical Needs Large total addressable Rapidly growing OV market Differentiated technology market with high unmet needs with early signals of efficacy • Large total addressable • Early signs of clinical market across current differentiation vs. competitor 202
Slide 8: Differentiated Pipeline Targeting Multiple Cancer Indications
Differentiated Pipeline Targeting Multiple Cancer Indications Non-clinical Pivotal Product Platform Target Indications Discovery Phase 1 Phase 2 Partner studies Trial Newly Diagnosed High Entering Phase 1b/2 Grade Glioma Cancer indications CLD-101 NeuroNova Recurrent High Grade Phase 1 started Gliom
Slide 9: Upcoming Key Milestones 2024
Upcoming Key Milestones 2024 2023 2024 1H 2H 1H 2H CLD-101 First patient dosed (NNV1) CLD-101 (NNV1) CLD-101 First patient Interim Clinical trial (NNV2) dosed CLD-101 results CLD-101 (NNV2) (NNV2) cGMP Final Drug Product First patient dosed CLD-201 CLD-201 Manufactured (SNV1) (SNV1) Non-clinical and
Slide 10: CLD-101 (NeuroNova)
CALIDI BIOTHERAPEUTICS
Slide 11: CLD-101: NeuroNova Overview
CLD-101: NeuroNova Overview Adenovirus (CRAd-S-pk7) for CLD-101 Amplifies selectively in HGG tumor cells Radiation treatment upregulates Survivin expression Calidi’s manufacturing of virus-loaded Neural Stem Cells is proprietary, scalable, reproducible and commercially viable 11
Slide 12: High-Grade Gliomas: Significant Market Opportunity
High-Grade Gliomas: Significant Market Opportunity U.S. High-Grade Gliomas New Diagnoses $10.2 B Total Addressable Market (2030) 13,400 13,200 13,000 $300- Treatment Cost 12,800 450k 12,600 12,400 12,200 12.8% CAGR (2021-2030) 12,000 11,800 11,600 300k Worldwide Cases/Yr. 22 23 24 25 26 27 28 29 30
Slide 13: CLD-101: Patient Selection Criteria
CLD-101: Patient Selection Criteria Neural Stem Cell Delivery of an Oncolytic Adenovirus in Newly Diagnosed Patients with Malignant Glioma: A First-in-Human, Phase 1 Clinical Trial (Lancet Oncology, 2021 Aug;22(8):1103-1114) CLD-101 (NSC-CRAd-S-pk7): Neural stem cells loaded with CRAd-S-pk7 - a chim
Slide 14: CLD-101: Significant Published Clinical Results
CLD-101: Significant Published Clinical Results • Treatment with CLD-101 (NSC-CRAd-S-pk7) was safe and tolerable • Treatment achieved favorable therapeutic outcomes in patients with newly diagnosed malignant glioma: best overall response saw one patient responding partially to treatment, another pro
Slide 15: CLD-101: Clinical Trial Results
CLD-101: Clinical Trial Results Patient Demographics Tumor Type Demographic Criteria N (N=12) % Tumor Criteria N (N=12) % 18-29 1 8 Wild type 10 83.3 40-49 3 25 IDH1 mutant 2 16.7 IDH1/2 status Age (years) 50-59 3 25 60-69 4 33 IDH2 mutant 0 0 70-79 1 8 Methylated 3 25 Male 5 42 MGMT Gender Unmethyl
Slide 16: CLD-101: Recurrent High-Grade Glioma Clinical Pathway
CLD-101: Recurrent High-Grade Glioma Clinical Pathway Ongoing Phase 1 trial at City of Hope Indication: Recurrent High-Grade Glioma First Patient In: Q2 2023 16
Slide 17: CLD-101: Newly-Diagnosed High-Grade Glioma Clinical Pathway
CLD-101: Newly-Diagnosed High-Grade Glioma Clinical Pathway Planned Phase 1b/2 Trial at Northwestern University Indication: Newly-Diagnosed High-Grade Glioma T1 First Patient In: 1H 2024 17
Slide 18: CLD-201 & CLD-202 (SuperNova)
CLD-201 & CLD-202 (SuperNova)
Slide 19: CLD-201: SuperNova Overview
CLD-201: SuperNova Overview Vaccinia Virus (CAL1) for SuperNova Not a serious human pathogen Safely used as a vaccine for smallpox Key natural attenuations improve tumor selectivity Highly cytolytic for most tumor types Large insertion capacity allows cloning of therapeutic payloads Safety study com
Slide 20: Calidi’s next generation product: CLD-201 – Allogeneic Stem Cells loaded with the CAL1 Virus
Calidi’s next generation product: CLD-201 – ALLOGENEIC Stem Cells loaded with the CAL1 Virus ADVANTAGES of Using Allogeneic Stem Cells: IMPROVED POTENCY: larger number of viral particles inside the stem cells BETTER REPRODUCIBILITY: CLD-201 product is composed of cultured and expanded mesenchymal st
Slide 21: CLD-201 Market Opportunity: Solid Tumors
CLD-201 Market Opportunity: Solid Tumors Solid tumors have a significant total addressable market in multiple cancer types U.S. Estimated Addressable Market – Solid Tumors Global Solid Tumors Market Growth Tumor Type U.S. Annual Incidence U.S. Annual Deaths 600 NSCLC - Squamous 59,500 33,500 CAGR: 5
Slide 22: Phase 1 Safety Study with Autologous Stem Cells
Phase 1 Safety Study with Autologous Stem Cells First-in-human study of TK-positive oncolytic vaccinia virus delivered by adipose stromal vascular fraction cells Agent: SNV0: Adipose-derived autologous cells loaded with CAL1 – a non-modified oncolytic vaccinia virus Study design: Open-label, phase 1
Slide 23: Durable Tumor Regression and Survival
Durable Tumor Regression and Survival Calidi Autologous Safety Study: Positive Results in Combination With Checkpoint Inhibitor • Age/Sex: 70/M • Stage IV_B • Diagnosis: Metastatic Head & Neck SCC • Injected tumor was previously resistant to chemo- and radio-therapy Patient Case: Patient #SI01-021 D
Slide 24: Durable Tumor Regression and Survival (continued)
Durable Tumor Regression and Survival (continued) • Age/Sex: 68/M • Diagnosis: Thyroid Papillary Carcinoma • Stage IV Patient Case: Patient #SI01-047 Day 85 post-treatment: tumor Day 30 post-treatment Day 65 post-treatment has fully regressed Primary objective - Safety: There were no treatment-relat
Slide 25: Platform with Therapeutic Potential in Multiple Indications
Platform with Therapeutic Potential in Multiple Indications Discontinued monitoring of patients 1 year following their treatment 25
Slide 26: CLD-201: Planned Clinical Development of Allogeneic Platform
CLD-201: Planned Clinical Development of Allogeneic Platform A Phase 1/2 study of intra-tumoral administration of CLD-201, alone or in combination with checkpoint inhibitors, in patients with advanced metastatic solid tumors PART 1: PART 2: PART 3: Dose Escalation Expansion in Three Indications Expa
Slide 27: CLD-202: Cell-based systemic delivery
CLD-202: Cell-based systemic delivery PRECLINICAL STAGE DEVELOPMENT A new treatment option for advanced metastatic disease and un-targetable cancers using intratumoral administration 27
Slide 28: Target local and distant tumor sites
Target local and distant tumor sites Mouse model bearing 3 different solid tumor indications Calidi’s Systemic, Cell-based Virotherapy • Resistant to rapid inactivation by humoral immunity. Tumor Indication #1 • Effectively targets all tumor sites Tumor Indication #3 tested within the body. Tumor In
Slide 29: Company Overview
CALIDI BIOTHERAPEUTICS
Slide 30: Executive Team with Proven Track Record
Executive Team with Proven Track Record Boris Minev, Andrew Allan Camaisa M.D. Jackson Chairman & CEO President, Medical & Chief Financial Officer Scientific Affairs Antonio Wendy Stephen Pizarro, Esq. Thesing Santidrian, PH.D. Chief Administrative Chief Business Officer Officer & Chief Legal Chief
Slide 31: Calidi Board of Directors and Scientific Advisors
Calidi Board of Directors and Scientific Advisors Board of Directors Scientific Advisors Allan Camaisa Bernie Fox, Ph.D Chairman of the Board Immunology Laboratory Scott Leftwich W.K. Alfred Yung, M.D. Vice Chairman Professor, Neuro-Oncology George Ng Matt S. Lesniak, M.D. Director Chair, Department
Slide 32: Calidi’s Unique Value Proposition
Calidi’s Unique Value Proposition Overcoming Obstacles to Prior Universal Cancer Therapeutic Generation Oncolytic with Potential to Address a Immunotherapy Wide Range of Solid Tumors Solving the Challenge of Track Record of Successful Manufacturing with Scalable, Non-Dilutive Fundraising Commerciall
Slide 33: Thank You
Thank You Contact: Stephen Thesing Chief Business Officer sthesing@calidibio.com
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