Calidi Biotherapeutics, Inc. · AMEX:CLDI
Calidi Biotherapeutics — Investor Presentation (January 2024)
33 slides from Calidi Biotherapeutics's investor presentation, Jan 5, 2024
Slide 1: Cover
7, e System to Kill Cancer withaNew ; Lo saeiocon “i ‘ . / = ie Viel Sr, le al
Slide 2: Forward-Looking Statements and Legal Disclaimer
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,” “expect,” “
Slide 3: Investment Highlights
Investment Highlights CALIDi Calidi Biotherapeutics is a clinical-stage biotechnology company developing a new generation of targeted immunotherapies © C-101: Neural stem cell (NSC) product candidates loaded with oncolytic adenovirus SNM ( CL0-201; Allogeneic Adipose-derived Mesenchymal Stem Cells(A
Slide 4: Calidi Overcomes the Obstacles to Oncolytic Viral Therapy
Calidi Overcomes the Obstacles to Oncolytic Viral Therapy Unprotected Oncolytic Virus Allogeneic Oncolytic Virus-Loaded Stem Cells Rapid inactivation, by immune Tumoris Untouched Naked oncolytic viruses are quickly eliminated by the patient’s immune system, leading to limited therapeutic potential C
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 Fd Immune Rejection Stealth Low immunogenicity (Stealth) fn Cost High Low va
Slide 6: Calidi's Platform Advantages
Calidi’s Platform Advantages CALIDI 2 Fp!imune “GenecG> AMGEN Ene Gustinwes Cell Protected: Platform Engineered Virus Vv Vv Vv Vv Vv Vv Vv 4 a , Adenovirus er Vaccinia Virus | Herpes Virus Vaccinia Virus Herpes Virus Adenovirus Vaccinia Virus Herpes Virus Adenovirus e Reduced viral elimination by th
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 market with high unmet needs Large total addressable Early signs of clinical market across current differentiation vs. competitor indications of focus: base Melanoma, GEM, TNBG, HEN 1 6-8 40 ass
Slide 8: Differentiated Pipeline Targeting Multiple Cancer Indications
Differentiated Pipeline Targeting Multiple Cancer Indications icat i Non-clinical Pivotal Product Platform Target Indications Discovery as Phase Phase2_ Pt Partner Newly Diagnosed High @EURIREEn a Grade Glioma S$ ‘CLD-101 NeuroNova S Recurrent High Grade * & enttiat Phas 4 start arm Bg 3 & ‘Advanced
Slide 9: Upcoming Key Milestones 2024
Upcoming Key Milestones 2024 |S 2 | 2024 1H 2H 1H 2H CLD-101 ist patient dosed (wnva) CLD-101 (NV) CLD-101 G First patient @ Interim Clinical rial (wnv2y Feet pam results CLD-101 (NNV2) (cove Final Drug Product CLD-201 Manufactured (snviy (snva) [Non-clinical and IND enabling studies completed. G Fi
Slide 10: Calidi Biotherapeutics
CALIDi BIOTHERAPEUTICS
Slide 11: CLD-101: NeuroNova Overview
CLD-101: NeuroNova Overview Neural Stem Cell © Amplifies selectively in HGG tumor cells Neural Stem Calls that deliver © Radiation treatment upregulates Oncoytic Adenoviruses Survivin expression Survivin promoter Re-engineered Oncolytic CALIDi
Slide 12: Grade Gliomas: Significant Market Opportunity
Grade Gliomas: Significant Market Opportunity ve U.S. High-Grade Gliomas New Diagnoses Total Addressable cae Market (2030) 13,400 13,200 13,000 $300- ‘450k Treatment Cost 12,800 12,600 12,400 12,200 12.8% CAGR (2021-2030) 12,000 11,800 11,600 300k Worldwide Cases/Yr. CALIDi 2
Slide 13: Neural Stem Cell Delivery of an Oncolytic Adenovirus: Phase 1 Trial
Cenea 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 chimeric adenoviral vector contain
Slide 14: CLD-101: Significant Published Clinical Results
CLD-101: Significant Published Clinical Results A 8 3007 — Aipatiens 200 — MGM unmethylated Ss -B t 5 so. é 23. ° “I : o é 2 18 2 By 3% ° é 2 1% 2 0 Number at risk “ . Numberat ek Times sary (months) (numberof events) (numberof events) ‘Allpatints 12(0) 20) 30) 3) 20) 100) Alpatints 120) 2) TOY) 2H)
Slide 15: Clinical Trial Results
: Clinical Trial Results Patient Demographics Tumor Type Se 18-29 Wild type 83.3 bts S eB IDH1 mutant 2 16.7 Age (years) 50-59 3 25 e019 A a IDH2 mutant 0 0 70-79 a 8 Methylated 3 25 Male 2 a2 Unmethylated 9 Ss Female 7 58 , 1 1 0 0 2 8.33% (0.21%, 38.48%) iRANO Tumor Response Rate 10 2 2 6 2 83.33%
Slide 16: Recurrent High-Grade Glioma Clinical Pathway
01: Recurrent High-Grade Glioma Clinical Pathway Ongoing Phase 1 trial at City of Hope Cityof Indication: Recurrent High-Grade Glioma H fe) p e STUDY PROCEDURES: [ Cycles1 | Cycle 2 Cycle 3 Cycle 4 Devt Dey! Davi Devt + Tumor resetion + CF and bizsd collection || + CSF andbitad collection ||» CSF an
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 DLT period 13 14 Consent & enrollment CALIDi Resection & implant of CED catheters |__| 2 weeks 4 weeks 4 weeks | — 4 weeks Northwestern Univer
Slide 18: Calidi Biotherapeutics
CALIDi BIOTHERAPEUTICS
Slide 19: CLD-201: SuperNova Overview
CLD-201: SuperNova Overview Vaccinia Virus (CAL1) for SuperNova © Nota 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
Slide 20: Calidi's next generation product: CLD-201 Stem Cells loaded with CAL1 Virus
Calidi’s next generation product: CLD-201 — 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 stem cell
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 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: NSCL
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: SNVO: 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 re Results in Combination With Checkpoint Inhibitor Calidi Autologous Safety Study: Po: + 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 #S101-021 Day
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 #S101-047 Day 85 post-treatment: tumor Day 30 post-treatment Day 65 post-treatment has fully regressed " Primary objective - Safety: There were no treatment-rel
Slide 25: Platform with Therapeutic Potential in Multiple Indications
Platform with Therapeutic Potential in Multiple Indications Tumor Type | Age (M/F) Diagnosis Date of Date of Known Survival Diagnosis Treatment Post Treatment (Months) Head & Neck Left parotid 12/16/2015 pleomorphic adenoma Head & Neck 33/M SalivaryGland 2013 wc 6/10/2016 23 CA & Lung Mets Thyroid 6
Slide 26: CLD-201: Planned Clinical Development of Allogeneic Platform
CLD-201: Planned Clinical Development of Allogeneic Platform a A 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: Dose Escalation Expansion in Three Indications * Classi
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 #2 Effectively targets all tumor sites tested within the body. Tumor Indication #3. a Indicat
Slide 29: Calidi Biotherapeutics
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 & Chiet Financial Officer Scientific Afairs Antonio Wendy Stephen " Thesing Santidrian, Pizarro, Esq. PH.D. Chief Administrative Chiet Business Officer Officer & Chief Legal Chie
Slide 31: Calidi Board of Directors and Scientific Advisors
Calidi Board of Directors and Scientific Advisors Board of Directors Scientific Advisors Allan Camaisa anakam’ 494-64 ereate, Bernie Fox, Ph.D PROVIDENCE Chairman of the Board sca dae Immunology Laboratory Cancer Institute Scott Leftwich anakany inna, C2eyy Wok. Alfred Yung, M.D. Ti univ erro Vice C
Slide 32: Calidi's Unique Value Proposition
Calidi’s Unique Value Proposition {Q)— Overcoming Obstacles to Prior - — Onn | Universal Cancer Therapeutic Generation Oncolytic with Potential to Addressa Immunotherapy Wide Range of Solid Tumors Solving the Challenge of Track Record of Successful Manufacturing with Scalable, _ Non-Dilutive Fundrai
Slide 33: Calidi Biotherapeutics
CALIDi BIOTHERAPEUTICS
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