Calidi Biotherapeutics, Inc. · AMEX:CLDI
Calidi Biotherapeutics — Investor Presentation (April 2024)
34 slides from Calidi Biotherapeutics's investor presentation, Apr 19, 2024
Slide 1: Virotherapies Designed to Arm the Immune System and Attack
Virotherapies Designed to arm the immune system and attack ever’ April 15, 2024 ~ CALIDi ‘BIOTHERAPEUTECS
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 Factor Summary
RISK FACTOR 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 affe
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 Cancer Immunotherapy L C 1 Passive Immunotherapy Active Immunotherapy ome Immunotherapeutics used to compensate for missing/deficient _ Immunotherapeutics used to stimulate effector functions in the ¢ A i
Slide 5: Calidi Biotherapeutics company overview
CALID és) 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 c
Slide 6: Calidi Overcomes the Obstacles to Oncolytic Viral Therapy
Calidi Overcomes the Obstacles to Oncolytic Viral Th rapy Unprotected Oncolytic Virus Allogeneic Oncolytic Virus-Loaded Stem Cells ative Rapid inactivation Oncolyte Viruses “Tumor is Untouched Naked oncolytic viruses are quickly eliminated by the patient’s immune system, leading to limited therapeut
Slide 7: Calidi's Platform Advantages (NeuroNova and SuperNova)
Calidi's Platform Advantages (NeuroNova-and SuperNova) CALIDI er resinne GRAD O x NCOLOCY iMUGENE Ticker Symbol NYSEAM:CLDI| | NASDAQ:REPL —NASDAQ:GNIX _NASDAQ:ONCY —-NASDAQ:CADL___NASDAQ:CGON ASKIMU Stage of Development Phase 1 Phase 3 Phase 3 Phase 3 Phase 3 Phase 3 Phase 2 Market Cap $24.5M 3/a/2
Slide 8: Calidi Oncology Pipeline
Calidi Oncology Pipeline Pivotal Phased Phase PCS Partner Product Platform Target Indications Discovery Newly Diagnosed High Grade Glioma Soft tissue Sarcoma (Localized administration) (Systemic administration) Multiple partnership opportunities to potentiate and deliver other existing OV’s, combina
Slide 9: Upcoming Planned Milestones (2024-2025)
Upcoming Planned Milestones (2024-2025) 14 ra 14 2H cp-101 Clinical a enrollment a {NN mul doses em 2iDA commun pate WH ini til Update iat trl Update teal denoted HCO) to dose fist patient {311 orESMO meting) {asco meeting) Fete pial ae Darna crane continued gag clinical rial enrollment i competion
Slide 10: Calidi's Three Lead Programs
Calidi’s Three Lead Programs CLD-101 (NeuroNova) Clinical trial Phase 1b/2 CLD-201 (SuperNova) Targeting clinic 2H 2024 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 11: CLD-101 (NeuroNova)
-~ CLD-101 (NeuroNova) Designed to Attack High / Grade Glioma Brajpeancer Kyi
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 ‘ 2 on = spt Tee . a i Es : P Ps ° = ° 6 2 8 24 30 6 i erate meres 38 8S ‘Allpatients 12(0) 1002) 309) 319) 2(9) 100) . i ° ° - 7 : * Treatment with CLD-101 (NSC-CRAd-S-pk7) was well tolerated + Treatment achieved favorable the
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 ndication: Recurrent High-Grade Glioma —— $12m CIRM Cycle 1 Cycle 2 [cycles | Cycle 4 Dav . oS Davi Davi + Tumor resection + esFand + CF and blood callection || - CF and Blood cotton + Manual administration o
Slide 15: CLD-101: Newly-Diagnosed High-Grade Glioma Clinical Pathway
1: Newly-Diagnosed High-Grade Glioma Clinical Pathway. Northwestern * Planned Phase 1b/2 Trial at Northwestern University rthwe University Indication: Newly-Diagnosed High-Grade Glioma DLT period 1 13 14 TI ; ) First Patient . ® in Consent & Resection \ - | | 1H 2024 enrollment & implant {Radiation
Slide 16: CLD-201 (SuperNova)
CLD-201 (SuperNova) * Localized administration For Skin Cancers, Head & Neck, TNBC, and Soft Tissue Sarcoma ~ CALIDi ‘BIOTHERAPEUTECS
Slide 17: Maximizing Therapeutic Responses with Directed Localized Administration
Maximizing Therapeutic Responses with Directed Localized Administ Directed ocalized adi istration CLD-101 (Neuronova) v High therapeutic index of treated lesion/areas Completed Phase 1 Vv Low toxicity Vv Strong activation of local and systemic antitumor immunity CLD-201 (Supernova) Phase 1 @ 2H-2024
Slide 18: 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 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 #S101-021 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 ise: Patient #S101-047 Day 85 post-treatment: tumor Day 30 post-treatment Day 65 post-treatment has fully regressed ary objective - Safety: There were
Slide 21: Platform with Therapeutic Potential in Multiple Indications
Platform with Therapeutic Potential in Multiple Indications ‘Tumor Type ‘Age (M/F) Diagnosis Date of Date of Known Survival Diagnosis Treatment _| Post Treatment (Months) Left parot 12/16/2015 pleomorphic adenoma Head & Neck 33/M SalivaryGland 2013, ve e/10/016 23 CA Lung Mets Thyroid eM Thyroid CA
Slide 22: Phase 1/2 study of intra-tumoral administration of CLD-201
° 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: Dose Escalation in Five indications * — Classical 3+3 trial design. * Ten patients from each of 3 _ * 30 to 50 patients with the best
Slide 23: CLD-400 (RTNova)
CLD-400 (RTNova) * Systemic Administration Designed for advanced metastat disease, and for lung Cancer ~ CALIDi ‘BIOTHERAPEUTECS
Slide 24: 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 v Simple, cost-effective IV administration avoiding the need for image-guided delivery. CALIDi 024 Calidi Biotherapeutics, Inc.| Company Proprietary; Pat and pending Page 24
Slide 25: Extracellular Enveloped Vaccinia (EEV) Backbone Designed for Systemic Delivery
Extracellular Enveloped Vaccinia (EEV) Backbone Designed for. Systemic Delivery 1- New engineered tumor selective Vaccinia virus (RT) 2- A large insertion capacity (25-45Kb), allowing delivering of existing therapeutic proteins into the tumor. 1- High production of enveloped viruses by manufacturing
Slide 26: Vaccinia Virus Strain Redtail
semination: Vaccinia Virus Strain (“Redtail”) Pr j ‘Vaccinia Viruses are genetically engineered to express TurboFP635 (red fluorescence). Comet assay of two distinct vaccinia viruses. Vaccinia virus strain CAL2 Redtail Vaccinia virus envRT-01 producing low EEV particle producing high levels of EEV p
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 [> Anovel technique for purifying extracellular enveloped viruses manufacturing protocol. (EVs), was required. EnvelopedRTO1 TL > Clinically relevant manufact
Slide 28: Protection Against Humoral Immunity
Protectio ¥ Particles Are é Resistant ay. i> Only Enveloped virotherapies can survive inactivation by human serum. Accritical step to achieving systemic delivery _ _ Humoral I Standard media Human Serum 12.4% Survival 79.3% Survival CALIDi 204 al Snerepevtn, no 1 Gonpny Propriety Pans sue an pen Pag
Slide 29: Systemic Administration of envRT-01 Can Target and Eliminate Multiple Tumors
Systemic Administration of envRTO1 Can Target‘and Eliminate Multiple Tumors After systemic administration, envRT-01 (enveloped RT-01) can target all distant tumors and express selected payload (such as TurboFP635) Remarkable Versatility: Ability to address diverse tumor types and adapt to the unique
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 Lung Carcinoma (LL2) 800: a Gi 41: Control a 2 : Greup 2 Ee ee 10-100 times lower dose E 600. : (compared to other vaccinia @ viruses) can inhibit tumor & growth effectively in 3 400 immunocomp
Slide 31: envRT-01 Induces T Cell Infiltration
envRT-01 Induces 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 CD11b (Myeloid) Vaccinia DAPI (tumor) Myeloid J Enhancement of anti-tumor effica
Slide 32: Driving Clinical Revolution Using Cells, or Cell-Oncolytic Virotherapies
Driving Clinical Revol ition Using Cells, or Cell- Oncolytic Virotherapies to a New Therapeu RTNova delivers a breakthrough in true systemic oncolytic 5 p virothera Systemic and localized Py = ir cera antitumor virothe epics ® Delivering on a vision for off-the-shelf platforms that are — scalable, a
Slide 33: Capitalization
Capitalization Securities (22/2020 Common Equivalents Total Common Issued and Outstanding 35,538,034 Public Warrants $11.50 11,500,000 Private Warrants $11.50“) 1,912,154 Options/RSUs Outstanding 7,945,117 Fully Diluted (2) 56,878,463 FconvertbieNoteswnnan | Prins | Note 1, matures 1/26/25 $1,000,00
Slide 34: Contact
Qwr pBIOTHERAPEUTICS Stephen Thesing Chief Business Officer Cell: +1 858.386.3776 Mai pict AS il: P idibio. . GPElidi Biotherapeutics, Inc. GtncetlbG sit aveuealtioncc ol a "74475 Executive Drive, Suite 200 Bs San Diego, CA92121 USA 543 > ~ a , es ah “9 - i www.calidibio.com é ; . wae ~
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