Calidi Biotherapeutics, Inc. · AMEX:CLDI
Calidi Biotherapeutics — Investor Presentation (October 2024)
28 slides from Calidi Biotherapeutics's investor presentation, Oct 18, 2024
Slide 1: Designed to attack every tumor
Virowier * Designed to attack every tumof (, and arm the _ October 17%" , 2024 a. OCALDI é . . BIOTHERAPEUTICS
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: Calidi is a clinical-stage biotechnology company transforming cancer treatment
epee Calidi Biotherapeutics is a clinical-stage biotechnology company that is CA transforming cancer treatment, with innovative oncolytic virotherapies (OV). BIOTHERAPEUTICS virotherapies into tumor sites, effectively overcoming the clinical challenge of Our cutting-edge cell-based technologies prot
Slide 5: 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 Active Rapid inactivation Oncolytic i Viruses Tumor is Untouched Naked oncolytic viruses are quickly eliminated by the patient’s immune system, leading to limited therap
Slide 6: Calidi Oncology Pipeline
Calidi Oncology Pipeline — ° Non-clinical Pivotal Product Platform Target Indications Discovery cmlss Phase 1 Phase 2 Trial Partner Newly Diagnosed High Grade i Glioma CLD-101 NeuroNova Advanced Solid Tumors: Head CLD-201 SuperNova & Neck, TNBC, Soft tissue FDA Pre-IND — Planned Phase 1 Sarcoma (Loc
Slide 7: Upcoming Planned Milestones (2024-2025)
Upcoming Planned Milestones (2024-2025) oot In FDA icati st B® clinical trial a - in FDA communication i inical tri : 1" patient dosed Clinical trial oo (NNV1: multiple doses Vv to dose first patient S Qpen Ind nwo vent dos: Clinical trial Update newly diagnosed HGG) Pi enrollment update (asco meeti
Slide 8: Calidi's Three Lead Programs
Calidi’s Three Lead Programs [ CLD-101 (NeuroNova) Clinical trial Phase 1b/2 Targeting clinic 2H 2024 } [ CLD-201 (SuperNova) J Pre-clinical CLD-400 (RTNova) } ( Indication: Recurrent and newly YY Indication: Advanced Solid Tumors:) 4 Indication: Lung Cancer, and diagnosed High Grade Glioma Metastat
Slide 9: Designed to Attack High Grade Glioma
—_ — Designed to Attack High Grade.Glioma . th
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 well tolerated * Primary Objective: analyze * Primary
Slide 11: 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 STUDY PROCEDU Day 1 + Tumor resection Manual administration of NSC-CRAd-S-pk7 + Placement of 2 Rickham catheters? + CSF° and blood collection Day 2 + CSF and blood
Slide 12: 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 ie Ez. e a. a. First Patient and In: Consent & Resection = | _ enrollment & implant Radiation > 1Q 2025 2 weeks 4 weeks 4 weeks 4 weeks Pa
Slide 13: CLD-201 (SuperNova)
CLD-201(SuperNova) ° Localized administration For Head & Neck, TNBC, and Soft Tissue a a BIOTHERAPEUTICS
Slide 14: Maximizing Therapeutic Responses with Directed Localized Administration
Maximizing Therapeutic Responses with Directed Localized Administration Directed — Localized administration } Vv High therapeutic index of treated lesion/areas Y Low toxicity Y Strong activation of local and systemic antitumor immunity Vv In situ vaccination Vv Efficacy of intratumoral approach show
Slide 15: CLD-201 (SuperNova) in Advanced Solid Tumors
01 (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 signals
Slide 16: 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 #S101-021 D
Slide 17: 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 Cas: lent #S101-047 Day 85 post-treatment: tumor Day 30 post-treatment Day 65 post-treatment has fully regressed Primary objective - Safety: Th
Slide 18: CLD-201: Planned Clinical Development
CLD-201: Planned Clinical Development ° A Phase 1/2 study of intra-tumoral administration of CLD-201, in patients with advanced solid tumors (Head & Neck, TNBC, soft tissue Sarcoma) PART 1: Dose Escalation in Five indications * Classical 3+3 trial design. Three dose levels will be tested, ° Three to
Slide 19: CLD-400 (RTNova)
& CLD- Nova) * “Systemic Administration Designed for eerenced Petaa ¢ disease, and for eon CALI BIOTHERAPEUTICS
Slide 20: Calidi's Systemic Approach (CLD-400 — RTNova program)
Calidi’s Systemic Approach (CLD-400 — RTNova program) v New treatment option for advanced metastatic disease, or lung Cancer Vv Simple, cost-effective IV administration avoiding the need for image-guided delivery. . CALIDi © 2024 Calidi Biotherapeutics, Inc. | Company Proprietary; Patents issued and
Slide 21: Redtail: An Extracellular Enveloped Vaccinia Strain Designed for Systemic Delivery
Redtail: An Extracellular Enveloped Vaccinia (EEV) Strain Designed for Systemic Delivery 1- High production of enveloped viruses is genetically encoded in virus genome. 2- Virus is manufactured enveloped with a human cell membrane containing human surface receptors offering: » Protection/immunomodul
Slide 22: Challenges and Solutions of Systemic Antitumor Virotherapies
Challenges and Solutions of Systemic Antitumor Virotherapies ~ (- \ ¢ Clinical Challenge: Current systemic virotherapies are Solution: RTNova (extracellular enveloped virotherapy) rapidly inactivated in minutes by the immune system, best-in-class virotherapy resistant to quick elimination by with on
Slide 23: Standard Media vs Human Serum
Standard Media Human Serum 12.4% Survival 79.3% Survival => A novel technique for purifying extracellular enveloped viruses (EEVs), was required. > Human host cell line: undisclosed > Only enveloped virotherapies can survive inactivation by human serum. Page 23
Slide 24: Systemic Administration of envRT01 Can Target and Eliminate Multiple Tumors
: FF : ee or? : — Systemic Administration of envRTO1 Can Target‘and Eliminate Multip! Ad Hi doa te ~ After systemic administration, envRT-01 (enveloped RT-01) can target all distant Untreated envRT-01 % Tumor Growth inhibition tumors and express selected payload (such (Average n=5) day 10 as TurboFP
Slide 25: Clinical and Regulatory Path Lead Candidate
Clinical and Regulatory Path Lead Candidate | 2025 | 2026 | 2027 | 2028 | 2029 | Pre-clinical, CMC & Regulatory Phase 1 Phase 2 pivotal trial ‘ Ye Vv « > INTERACT PrelND IND ( ») Clinical Design: Initial Indicat! Metastatic non-small cell lung cancer (mNSCLC) cancer *New cases NSCLC per year 197,000
Slide 26: Planned Clinical and Regulatory Path for Lead Candidate
Planned Clinical and Regulatory Path for Lead Candidate | | 2025 |2026 | 2027 Pre-clinical, CMC & Regulatory Phase 1 C Vv < ») INTERACT PrelND IND r Q3 2024 to Q2 2025 *Key Milestones: * Finalize selection of Lead Candidate + _IND-enabling pharmacology studies * Process and analytical development *
Slide 27: Pipeline and early partnership opportunities
Pipeline and early partnership opportunities EnvRT-01s * Tumor killing Metastatic NSCLC Lead generation * TME reprogramming, (Lung Cancer) GD ¢ Payload undisclosed EnvRT-02s * Tumor killing Advanced solid tumors Combo with * Prime solid tumors to (Indication undisclosed) qa Immune cell prepared for
Slide 28: Building the Future of Systemic Virotherapies
Building the Future of Systemic Virotherapies RTNova delivers a breakthrough in true systemic virotherapy using enveloped technology to target and attack all tumors. Planned phase 1 clinical trial, as a monotherapy, targeting metastatic lung cancer solid tumors in Q2 2026. Aiming to secure Fast-Trac
Calidi Biotherapeutics — Investor Presentation (October 2024) on 6ix