Calidi Biotherapeutics, Inc. · AMEX:CLDI
Calidi Biotherapeutics — Investor Presentation (January 2025)
31 slides from Calidi Biotherapeutics's investor presentation, Jan 10, 2025
Slide 1: Designed to attack every tumor and arm the immune system
Virowier * Designed to attack every tumof (, and arm the _ January 2025 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 (2025-2026)
Upcoming Planned Milestones (2025-2026) CLD-101 (NNV1: multiple doses GB 1% patient dosed WD ciinical trial BS BS newly diagnosed HGG) enrollment update Clinical trial Update Clinical trial Update CLD-101 (Nwv2: Multiple doses WD Clinical trial & biomarker B i | B 7 studies update . oo recurrent HGG
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 1H 2025 Pre-clinical ( Indication: Recurrent and newly ae Indication: Advanced Solid Tumors: ) Indication: Lung Cancer, and diagnosed High Grade Glioma Metastatic Cancer :
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 First Patient In: Resection _ . & implant ——|__ Radiation | ——> TRTeryr 2 weeks 4 weeks 4 weeks 4 weeks Consent & enrollment Page 12
Slide 13: CLD-201 (SuperNova)
CLD-201(SuperNova) ° Localized administration For Head & Neck, TNBC, and Soft Tissue a a BIOTHERAPEUTICS
Slide 14: 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 of
Slide 15: 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 16: 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 17: 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 18: 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 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. Y Able to survive in circulation and target tumor va sites Wan . CALIDi © 2025 Calidi
Slide 21: Why Systemic Virotherapies?
Why Systemic Virotherapies? 202 1 During presentations with several bio-pharma companies, we were challenged to develop a systemic antitumor virotherapy 5 Redtail’s platform was formally introduced in February 2024 and now in active discussion with 5 large cap global bio-pharma companies A systemic
Slide 22: 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/immunomodula
Slide 23: 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 24: Standard Media vs Human Serum survival
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 24
Slide 25: Systemic Administration of envRT-01 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 26: envRT Induces Major Tumor Immune Microenvironment Changes
envRT Induces Majo Leukocytes _ CD8+ cells Myeloid cells, a 80° bid 80 _ 80 2 100: bind = Jr z - q 3 8 oo 3 g ¥ a0: soa 2 “st g 70 . se 8 a0 ss & 3 82 £ % \ a a g ee oO 60: i gs 60- Py B 60. 2 40. 3 = a 7 4 x se 3 z @ 404 “2 x 2 40. . a “. / = et) / 3 ° 1 3 Boo 1G 20 3 - 204 ye Fy B 20: 3 : FE e | a
Slide 27: Systemic Administration of envRT-01 can eliminate lung cancer and metastasis
Systemic. Administration of envRTO1 can eliminate lung cancer.and metastasis One (1) dose (5e6 PFU) was able to decrease and eliminate lung cancer and metastatic tumors into the lung. a Control Bioluminescent Emission “> c @ 2.5*109. § z Metastasized = 1 sxt08: I Lung tumors Ss - rf { 2 tx108 ui a g
Slide 28: Systemic Administration of envRT Targets Lung Cancer and Metastatic Sites
« Systemic Administration of envRT Targets Lung ( ancer and Metastati - | Lungs: | Liver: | Control envRT-01 #1 #2 #3 #4 Control envRT-01 #1 #2 #3 #4 Tumor signal: Rainbow (Bioluminescence) Virus location: Red (Fluorescence) - LL2 lung cancer cells colonize lungs after - LL2 lung cancer cells coloni
Slide 29: envRT-01 Targets Metastasis
envRT-01 Targets Modulation — Targeting all metastasis: Immunohistochemistry data indicates systemic envRT-01 treatment targets metastasis inducing major infiltration of immune cells in all tumor loci. ( =" << = H&E Untreated tumor envRT-01 Page 29
Slide 30: 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 31: 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 Q3 2026. Aiming to secure Fast-Trac
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