Calidi Biotherapeutics, Inc. · AMEX:CLDI
Calidi Biotherapeutics — Investor Presentation (April 2024)
32 slides from Calidi Biotherapeutics's investor presentation, April 2024
Slide 1: Systemic and Localized Antitumor Virotherapies
Systemic and Localized Antitumor Virotherapies Designed to arm the immune system and attack every tumor April 2024
Slide 2: Novel platform: Off-the-shelf, cell-based allogeneic stem cells combined with oncolytic viruses
Novel platform: Off-the-shelf, cell-based allogeneic stem cells combined with oncolytic viruses Cell Therapy with OV Calidi is revolutionizing the effective delivery of oncolytic viruses for targeted therapy against difficult-to-treat cancers with an off-the-shelf, potent universal cell-based delive
Slide 3: Overview
Overview Calidi Biotherapeutics is a clinical-stage biotechnology company that is transforming cancer treatment, with innovative oncolytic virotherapies (OV). Our cutting-edge cell-based technologies protect and deliver oncolytic virotherapies into tumor sites, effectively overcoming the clinical ch
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: Calidi's Platform Advantages (NeuroNova and SuperNova)
Calidi's Platform Advantages (NeuroNova and SuperNova) Ticker Symbol NYSEAM:CLDI NASDAQ:REPL NASDAQ:GNLX NASDAQ:ONCY NASDAQ:CADL NASDAQ:CGON ASX:IMU Stage of Development Phase 1 Phase 3 Phase 3 Phase 3 Phase 3 Phase 3 Phase 2 Market Cap $24.5M 3/4/24 $460.6M $281.1M $83.7M $36.2M $2.4B $716.9M Cell
Slide 6: Calidi Oncology Pipeline
Calidi Oncology Pipeline Non-clinical Pivotal Product Platform Target Indications Discovery Phase 1 Phase 2 Partner studies Trial Newly Diagnosed High Grade Entering Phase 1b/2 Glioma CLD-101 NeuroNova Recurrent High Grade Glioma Phase 1 started $12M Advanced Solid Tumors Skin CLD-201 SuperNova canc
Slide 7: Upcoming Planned Milestones (2024-2025)
Upcoming Planned Milestones (2024-2025) 2024 2025 1H 2H 1H 2H CLD-101 CIRM Grant: continued Clinical trial enrollment Completion of dose Clinical trial & biomarker support (partner: COH) update – 4th Cohort escalation studies update Clinical trial Update (NNV2: Multiple doses recurrent HGG) (ASCO me
Slide 8: Calidi's Three Lead Programs
Calidi’s Three Lead Programs CLD-101 (NeuroNova) CLD-201 (SuperNova) CLD-400 (RTNova) Clinical trial Phase 1b/2 Targeting clinic 2H 2024 Pre-clinical Indication: Recurrent and newly Indication: Advanced Solid Tumors: Indication: Lung Cancer, and diagnosed High Grade Glioma Metastatic Cancer Tumor se
Slide 9: CLD-101 (NeuroNova)
CLD-101 (NeuroNova) Designed to Attack High Grade Glioma Brain Cancer
Slide 10: CLD-101 (NeuroNova) in High grade Glioma (HGG)
CLD-101 (NeuroNova) in High grade Glioma (HGG) Completed: Phase 1 (NWU) Ongoing: Phase 1 (COH) In preparation: Phase 1b/2 (NWU) Single dose multiple dose multiple dose in newly diagnosed HGG in recurrent HGG in newly diagnosed HGG • Treatment was safe and • 1ari Objective: analyze safety • 1ari Obje
Slide 11: CLD-101: Significantly Increased Survival and Published Clinical Results
CLD-101: Significantly Increased Survival and Published Clinical Results • Treatment with CLD-101 (NSC-CRAd-S-pk7) was well tolerated • Treatment achieved favorable therapeutic outcomes in patients with newly diagnosed malignant glioma: best overall response saw one patient responding partially to t
Slide 12: 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 $12M Status: recruiting 4th cohort © 2024 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending Page 12
Slide 13: 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 In FDA communications © 2024 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending P
Slide 14: CLD-201 (SuperNova)
CLD-201 (SuperNova) • Localized administration For Skin Cancers, Head & Neck, TNBC, and Soft Tissue Sarcomas
Slide 15: Maximizing Therapeutic Responses with Directed Localized Administration
Maximizing Therapeutic Responses with Directed Localized Administration Directed – Localized administration CLD-101 (Neuronova) ü High therapeutic index of treated lesion/areas Completed Phase 1 ü Low toxicity ü Strong activation of local and systemic antitumor CLD-201 immunity (Supernova) Phase 1 @
Slide 16: CLD-201 (SuperNova) in Advanced Solid Tumors
CLD-201 (SuperNova) in Advanced Solid Tumors Completed: Safety Study In Preparation: Phase 1 (Calidi) Autologous settings - Single dose Allogeneic, off-the shelf - multiple dose • Treatment was safe and tolerable. • New allogeneic program developed to reach wider cancer population • Strong initial s
Slide 17: 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 18: Durable Tumor Regression and Survival (continued)
Durable Tumor Regression and Survival (continued) • Age/Sex: 68/M • Diagnosis: Thyroid Papillary Carcinoma • Stage IV Calidi Autologous Safety Study Patient Case: Patient #SI01-047 Day 85 post-treatment: tumor Day 30 post-treatment Day 65 post-treatment has fully regressed Primary objective - Safety
Slide 19: Platform with Therapeutic Potential in Multiple Indications
Platform with Therapeutic Potential in Multiple Indications Discontinued monitoring of patients 1 year following their treatment Calidi Autologous Safety Study © 2024 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending Page 19
Slide 20: 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, in patients with advanced solid tumors (Skin cancers, Head & Neck, TNBC, soft tissue Sarcoma) PART 1: PART 2: PART 3: Dose Escalation in Five Expansion in Three Indications Ex
Slide 21: CLD-400 (RTNova)
CLD-400 (RTNova) • Systemic Administration Designed for advanced metastatic disease, and for lung Cancer
Slide 22: Calidi's Systemic Approach (CLD-400 – RTNova program)
Calidi’s Systemic Approach (CLD-400 – RTNova program) ü New treatment option for advanced metastatic disease, or lung Cancer ü Simple, cost-effective IV administration avoiding the need for image-guided delivery. © 2024 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending P
Slide 23: Development of a New Enveloped Vaccinia (EEV) Backbone Designed for Systemic Delivery
Development of a New Enveloped Vaccinia (EEV) Backbone Designed for Systemic Delivery Virotherapy: 1- New engineered tumor selective Vaccinia virus (RT) 2- A large insertion capacity (25-45Kb), allowing delivering of existing therapeutic proteins into the tumor. Enveloped: 1- High production of enve
Slide 24: Dissemination: Vaccinia Virus Strain (Redtail) Produces High Levels of EEV Particles
Dissemination: Vaccinia Virus Strain (“Redtail”) Produces High Levels of EEV Particles Vaccinia Viruses are genetically engineered to Comet assay of two distinct vaccinia viruses. express TurboFP635 (red fluorescence). Vaccinia virus strain CAL2 Redtail Vaccinia virus envRT-01 producing low EEV part
Slide 25: New Manufacturing Process Ensures Second Membrane Integrity
New Manufacturing Process Ensures Second Membrane Integrity, and Maximized Resistance Against Humoral Immunity Potency of EEV after different A novel technique for purifying extracellular enveloped viruses manufacturing protocol. (EEVs), was required. EnvelopedRT01 Clinically relevant manufacturing
Slide 26: Protection: Only Enveloped Vaccinia Particles Are Resistant to Humoral Immunity
Protection: Only Enveloped Vaccinia Particles Are Resistant to Humoral Immunity Only Enveloped virotherapies can survive inactivation by human serum. A critical step to achieving systemic delivery Standard media Human Serum Non-enveloped Vaccinia virus 12.4% Survival Vaccinia virus Enveloped 79.3% S
Slide 27: Systemic Administration of envRT01 Can Target and Eliminate Multiple Tumors
Systemic Administration of envRT01 Can Target and Eliminate Multiple Tumors Mouse model bearing 3 different human solid tumor types After systemic administration, envRT-01 (enveloped RT-01) can target all distant Untreated envRT-01 % Tumor Growth inhibition tumors and express selected payload (such
Slide 28: Systemic Administration of envRT-01 in Immunocompetent Lung Tumor-Bearing Models
Systemic Administration of Enveloped Virotherapies (envRT-01) in Immunocompetent Lung Tumor-Bearing Models 10-100 times lower dose (compared to other vaccinia viruses) can inhibit tumor growth effectively in immunocompetent animals. Tx Remarkable tumor selectivity. Days post tumor implantation envRT
Slide 29: envRT-01 Induces Major Modulation of Tumor Immune Microenvironment
envRT-01 Induces Major Modulation of Tumor Immune Microenvironment Immunohistochemistry data indicates envRT-01 treatment induces major infiltration of CD8 and CD4 T cells and reduction of myeloid population (Breast cancer tumors). Untreated tumor envRT-01 Color legend CD8 T CD4 T CD11b (Myeloid) Va
Slide 30: Driving Clinical Revolution Using Cells, or Cell-Membranes, to Advance Oncolytic Virotherapies
Driving Clinical Revolution Using Cells, or Cell-Membranes, to Advance Oncolytic Virotherapies to a New Therapeutic Level RTNova delivers a breakthrough in true systemic oncolytic virotherapy Systemic and localized antitumor virotherapies Delivering on a vision for off-the-shelf platforms that are s
Slide 31: Capitalization
Capitalization Securities (3/22/2024) Common Equivalents Total Common Issued and Outstanding 35,538,034 Public Warrants $11.50 (1) 11,500,000 Private Warrants $11.50 (1) 1,912,154 Options/RSUs Outstanding 7,945,117 Fully Diluted (2) 56,878,463 Convertible Notes (3/22/2024) Principal Note 1, matures
Slide 32: Stephen Thesing
Stephen Thesing Chief Business Officer Cell: +1 858.386.3776 email: [email protected] Calidi Biotherapeutics, Inc. 4475 Executive Drive, Suite 200 San Diego, CA 92121 USA www.calidibio.com
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