Calidi Biotherapeutics, Inc. · AMEX:CLDI
Calidi Biotherapeutics — Corporate Update (September 2024)
27 slides from Calidi Biotherapeutics's corporate update, Sep 12, 2024
Slide 1: Technology Update, September 11, 2024
viroaee ~j - Designed to attack every tumore arm the immune syst Technology Update a September 11, BIOTHERAPEUTICS CALI
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: Calidi Biotherapeutics is a clinical-stage biotechnology company
” Calidi Biotherapeutics is a clinical-stage biotechnology company that is CALIDi transforming cancer treatment, with innovative oncolytic virotherapies (OV). SIOTHERAPEUTICS virotherapies into tumor sites, effectively overcoming the clinical challenge of Our cutting-edge cell-based technologies pro
Slide 4: Introducing Dr. George Peoples, MD, FACS
Introducing Dr. George Peoples, MD, FACS ¢ Founder and Director of the Cancer Vaccine Development Program (CVDP) ¢ Founder of LumaBridge (formerly Cancer Insight), an oncology-focused Contract Research Organization (CRO) and development partner currently engaged with over 25 pre-clinical and clinica
Slide 5: Calidi Overcomes the Obstacles to Oncolytic Viral Therapy
Calidi Overco the Obstacles to Oncolytic Viral Therapy Unprotected Oncolytic Virus Allogeneic Oncolytic Virus-Loaded Stem Cells Tes Rapid inactivation ‘Stem cell ith, : o byimmune | |" ‘ s Stem cell protects Se ne | et, andamities OV Tumor is Untouched Naked oncolytic viruses are quickly eliminated
Slide 6: Calidi Oncology Pipeline
Calidi Oncology Pipeline Product Platform Target Indications Discovery Nonielnics| Phase1 Phase2_—‘Pivotal Partner studies Trial Newly Diagnosed High Grade Entering Phase thi Advanced Solid Tumors: Head cLD-201 SuperNova & Neck, TNBC, Soft tissue iRM Sarcoma if $3M CIRM (Localized administration) Me
Slide 7: Calidi's Three Lead Programs
Calidi’s Three Lead Programs CLD-101 (NeuroNova) Clinical trial Phase 1b/2 CLD-201 (SuperNova) Targeting clinic Q1 2025 CLD-400 (RTNova) Pre-clinical Indication: Recurrent and newly diagnosed High Grade Glioma Tumor selective Virotherapy: Adenovirus: CRAD-s-Pk7 Delivery vehicle/potentiator: Allogene
Slide 8: CLD-201 cutting-edge intratumoral administration
CLD-2 cuttin ¢ Intratun | administration Pr For Head & Neck TNBC, Elare| Soft Tissue a BIOTHERAPEUTICS
Slide 9: Maximizing Therapeutic Responses with Intratumoral Administration
Maximizing Therapeutic Responses with Intratumoral Administration Intratumoral administration ] CLD-101 (Neuronova) v High therapeutic index of treated lesion/areas Completed Phase 1 v Low toxicity Vv Strong activation of local and systemic antitumor immunity CLD-201 (Supernova) Phase 1 @ 1Q-2025 }
Slide 10: 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 11: 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 :
Slide 12: 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 Day 85 post-treatment: tumor Day 30 post-treatment Primary objective - Safety: There were no treatment-related side effects Secondary objective, Respon
Slide 13: CLD-201: Planned Clinical Development of Allogeneic Program
CLD-201: Planned Clinical Development of Alloge lei ° 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 Three indications * Classical 3+3 trial design. Four © * CLD-201 dose is iden
Slide 14: Calidi's Three Lead Programs
Calidi’s Three Lead Programs CLD-101 (NeuroNova) Clinical trial Phase 1b/2 CLD-201 (SuperNova) Targeting clinic Q1 2025 CLD-400 (RTNova) Pre-clinical — Indication: Recurrent and newly diagnosed High Grade Glioma Tumor selective Virotherapy: Adenovirus: CRAD-s-Pk7 Delivery vehicle/potentiator: Alloge
Slide 15: Systemic Antitumor Virotherapies
Systemic Antitumor . a) Virotherapies ; eg . Designed to target and attack : z | every tumor, empowering the immune system . re .e eS . Redtail » “é | | Biopharma
Slide 16: Challenges and Solutions of Systemic Antitumor Virotherapies
Challenges and Solutions of Systemic Antitumor Virotherapies r Clinical Challenge: Current systemic virotherapies are rapidly inactivated in minutes by the immune system, with only 0.1-5%* remaining intact, limiting the ability to reach the tumor RAPID INACTIVATION BY THE PATIENT'S IMMUNE SYSTEM \ 6
Slide 17: Vaccinia Virus as a Systemic Antitumor Virotherapy and Viral Vector
Vaccinia Virus as a Systemic Antitum6r Virot py’and Viral Vector 1- RT Vaccinia virus is a highly cytolytic virus - tumor agnostic. 2- Genetically stable. 200kB dsDNA virus. 3- Large insertion capacity (25-45Kb), allowing delivery of existing therapeutic proteins into the tumor, potentiating antitum
Slide 18: Redtail: An Extracellular Enveloped Vaccinia (EEV) 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 19: High Levels of EEV Particles
© igh 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 producing low EEV particle Ashort and round plaque signifies that the virus mainly spreads from cell to cell.
Slide 20: 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 20
Slide 21: Systemic Administration of envRT-01 Can Target and Eliminate Multiple Tumors
Systemic Administration of envRT01.Gan Target and.Eliminate Multiple Tumors After systemic administration, envRT-01 Mouse model bearing 3 different human solid tumor types (enveloped RT-01) can target all distant Untreated envRT-01 sé rage eroweH WNIbIIR tumors and express selected payload (such (Av
Slide 22: Systemic Administration of Enveloped Virotherapies (envRT-01) in Immunocompetent Lung Tumor-Bearing Models
Systemic Administration of EnvelopedWirothérapies (envRT-01) in ImmuUnocompetent Lung Tumor-Bearing Models Lung Carcinoma (LL2) — 800: ro) ‘& Group 1: Control A = © Group 2: RT-01 we 10-100 times lower dose : E 600 (compared to other vaccinia ® viruses) can inhibit tumor E growth effectively in g a0
Slide 23: Cancer and Metastatic Sites
‘£ OF Cancer and Metastatic Sites Lungs: Control envRT-01 #1 #2 #3 #4 Tumor signal: Rainbow (Bioluminescence) Virus location: Red (Fluorescence) - LL2 lung cancer cells colonize lungs after IV administration. - Systemic administration of envRT-01 targets multiple tumor loci. LL2 lung cancer cells co
Slide 24: Untreated tumor vs envRT-01
Untreated tumor envRT-01 Page 24
Slide 25: Clinical and Regulatory Path: Lead Candidate
Glinical’and Regulatory Path*Lead Candidate I | 2025 | 2026 | 2027 | 2028 | 2029 Pre-clinical, CMC & Regulatory Phase 1 Phase 2 pivotal trial VV V¢ INTERACT PreIND_ IND Clinical Design: Initial Indication: Metastatic non-small cell lung cancer (mNSCLC) cancer *New cases NSCLC per year 197,000 “Death
Slide 26: 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
Slide 27: Thank You!
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