Calidi Biotherapeutics, Inc. · AMEX:CLDI
Calidi Biotherapeutics — Investor Presentation (August 2024)
23 slides from Calidi Biotherapeutics's investor presentation, Aug 22, 2024
Slide 1: Systemic Antitumor Virotherapies
Systemic Antitumor 7a my Virotherapies o.0 2 en Designed to target and attack : ; oe / p : every tumor, empowering the x immune system Redtail » ae Biopharma
Slide 2: Safe Harbor Statement
Safe Harbor Statement This presentation and other written or oral statements made from time to time by representatives of Calidi Biotherapeutics, Inc. ( “Calidi”) and /or its wholly owned subsidiary Redtail Biopharma, Inc. (together with Calidi and its consolidated subsidiaries, the “Company’), may
Slide 3: Overview: Fulfilling the Promise of Systemic Virotherapies
Overview: Fulfilling the Promise of Systemic Virotherapies y Redtail Biopharma is a biotechnology company that is transforming cancer treatment, ——_—-with innovative systemic antitumor virotherapies. Our cutting-edge technology, an extracellular enveloped virotherapy (EEV) named O Redtail virus (RTN
Slide 4: Redtail History and Why Systemic Virotherapies?
Redtail History and 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 c
Slide 5: Challenges of Immunotherapies in Treating Solid Tumors
Challenges of Immunotherapies‘in Treating Solid Tumors (— >) Immunotherapies Immunosuppressive tumor microenvironment @ Immunotherapy MOA: relies on activated immune cells infiltrating and persisting within tumors to mount an effective Cytokines @ 3| x, response. Sate —_— owe CAR-T&other © 6 * 1 e I
Slide 6: Challenges and Solutions of Systemic Antitumor Virotherapies
Challenges and Solutions of Systemic Antitumor Virotherapies \ 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 ~ r
Slide 7: Mechanism of Action of RTNova Systemic Antitumor Virotherapies
Mechanism of Action of RINova‘Systemic Antitumor Virotherapies ® RTNova, an antitumor @) Oncolysis (Antitumor Virotherapy): @) Targeting all tumor sites and systemic Virotherapy - Direct killing of Tumors cells Y Selected initial indications treatment option designed to: Seen - Virus self-amplificat
Slide 8: Vaccinia Virus as a Systemic Virotherapy and Viral Vector
Vaccinia Virus as a Systemi Virotherapy ‘and Viral Vector 1- RT Vaccinia virus is a highly cytolytic virus - tumor agnostic. 2- Genetically stable. 200kB dsDNA virus. a \ ~ 3- Large insertion capacity (25-45Kb), allowing delivery of existing therapeutic proteins into the tumor, potentiating antitumo
Slide 9: New Vaccinia Backbone Designed for Systemic Delivery
New Vaccinia Backbone Designed for Systemic Delivery > Vaccinia virus has 2 main forms: 1- EEV (Extracellular Enveloped Virus) (Protected) /> EEV Ke oO ad a Actin tails Air HEY, - VACV cycle Virus factory 2- IMV particles (intracellular Mature Virus) (Unprotected) Figure adapted from: Geoffrey L Smi
Slide 10: Vaccinia Viruses are genetically engineered to express TurboFP635
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 y SS Redtail (RT) Strain a A long “tai that the virus can produce high levels of EEV leading to further spread. A s
Slide 11: Redtail: An Extracellular Enveloped Vaccinia (EEV) Strain Designed for Systemic Delivery
Redtail: An Extracellular Enveloped Vaccinia (EEV) StrainsDesigned for Systemic Delivery r . 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/immunom
Slide 12: Multifunctional Human Surface Proteins Expressed in Enveloped Viral Particles
Multifunctional Human Surface Proteins’Expressed in.Enveloped Viral Particles Example flow cytometry of viral particles expressing CD55 (DAF) ( >) Enveloped viruses incorporate human surface proteins Non-enveloped in their extracellular envelope. Examples: CD55 > Protection against humoral immune sy
Slide 13: envRT-01
envRT-01 Standard Media S . @ a 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 13
Slide 14: Eliminate Multiple Tumors
OF id-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 tumor microenvironment within the organism.
Slide 15: Systemic Administration of Enveloped Virotherapies (envRT-01) in Immunocompetent Lung Tumor-Bearing Models
Systemic Administration of Enveloped,Wirothérapies (envRT-01) in ImmuUnocompetent Lung Tumor-Bearing Models Lung Carcinoma (LL2) 800 oO & Group 1: Control . e © Group 2: RT-01 - 10-100 times lower dose ; —£ 600 (compared to other vaccinia o viruses) can inhibit tumor E _ growth effectively in g ** i
Slide 16: Tumor signal and virus location imaging
Tumor signal: Rainbow (Bioluminescence) Virus location: Red (Fluorescence) Note: animals were euthanized, and organs imaged 6 days following 1 single administration of envRT-01 treatment. | Lungs: Control envRT-01 #1 #2 #3 #4 Liver: - LL2 lung cancer cells colonize lungs after IV administration. - S
Slide 17: envRT-01 Induces Major Modulation of Tumor Immune Microenvironment
envRT-01 Induces Major Modulation of Tumor Immune Microen Leukocytes CD3+T cells CD8+ cells Myeloid cells = 80: Ed 80: 60: Z 100: ae 3 i -_ = 2 gz gi zg 3 = 3 ° oo 2 meet 5 ro . Soo 3 on 5 *° 3 3, g sy * 5 ~. 8 2° “. 8 60 = g \ : : £ 3 . g q z = 60 : ¥ 60. 3 40 = . 3 & ? a . : Eo 2 07 zy 2 40. *. =
Slide 18: Targeting all metastasis: Immunohistochemistry data
on 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 18
Slide 19: 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 « \F V C > INTERACT PreIND IND ( ») me Clinical Design: Initial Indicat! Metastatic non-small cell lung cancer (mNSCLC) cancer *New cases NSCLC per year 197,0
Slide 20: Planned Clinical and Regulatory Path for Lead Candidate
Planned Clinical and Regulatory Path for Lead Candidate I | 2025 | 2026 | 2027 | 2028 | 2029 | Pre-clinical, CMC & Regulatory Phase 1 Phase 2 pivotal trial c hy ev Vv < > INTERACT PrelND IND — >) Q3 2024 to Q2 2025 *Key Milestones: * Finalize selection of Lead Candidate + _IND-enabling pharmacology
Slide 21: Pipeline and early partnership opportunities
Pipeline‘and early partnership opportunities EnvRT-01s * Tumor killing Metastatic NSCLC Lead generation * TME reprogramming, (Lung Cancer) * Payload undisclosed EnvRT-02s * Tumor killing Advanced solid tumors Combo with * Prime solid tumors to (Indication undisclosed) qa Immune cell prepared for com
Slide 22: 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 23: ily
ily Biopharma = 4475 Executive Drive, Suite 200 San Diego, CA92121 USA
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