Calidi Biotherapeutics, Inc. · AMEX:CLDI
Calidi Biotherapeutics — Investor Presentation (April 2024)
34 slides from Calidi Biotherapeutics's investor presentation, Apr 15, 2024
Slide 1: Systemic and Localized Antitumor Virotherapies
Systemic and Localized Antitumor Virotherapies Designed to arm the immune system and attack every tumor April 15, 2024
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: Risk Factors
RISK FACTORS The risk factors summarized below could materially harm our business, operating results and/or financial condition, impair our future prospects and/or cause the price of our common stock to decline. These risks are discussed more fully following this summary. Material risks that may aff
Slide 4: 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 5: 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 6: 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 7: 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 8: 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 9: Upcoming Planned Milestones (2024-2025)
Upcoming Planned Milestones (2024-2025) 2024 2025 1H 2H 1H 2H CLD-101 Clinical trial enrollment (NNV1: multiple doses In FDA communication update Clinical trial Update to dose first patient Clinical trial Update newly diagnosed HGG) (SITC or ESMO meeting) (ASCO meeting) (SITC or ESMO meeting) CLD-10
Slide 10: 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 11: CLD-101 (NeuroNova)
CLD-101 (NeuroNova) Designed to Attack High Grade Glioma Brain Cancer
Slide 12: 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 well tolerated • Primary Objective: analyze • Primary
Slide 13: 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 14: 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 14
Slide 15: 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 16: CLD-201 (SuperNova)
CLD-201 (SuperNova) • Localized administration For Skin Cancers, Head & Neck, TNBC, and Soft Tissue Sarcomas
Slide 17: 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 18: 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 well tolerated. • New allogeneic program developed to reach wider cancer population • Strong initial signa
Slide 19: 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 20: 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 21: 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 21
Slide 22: 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 23: CLD-400 (RTNova)
CLD-400 (RTNova) • Systemic Administration Designed for advanced metastatic disease, and for lung Cancer
Slide 24: 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 25: Extracellular Enveloped Vaccinia (EEV) Backbone Designed for Systemic Delivery
Extracellular 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 enveloped v
Slide 26: 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 27: 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 28: 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 29: 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 30: 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 31: 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 32: 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 33: 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 34: 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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