Slide 1: Analyst Teach-In Day: Arming the Immune System to Kill Cancer
Exhibit 99.1 The following is a presentation for use by Calidi Biotherapeutics, Inc. and First Light Acquisition Group (FLAG) at an analyst day on August 16, 2023 in connection with their proposed business combination. ANALYST TEACH -IN DAY | AUGUST 2023 Arming the Immune System to Kill Cancer A nov
Slide 2: Forward-Looking Statements and Legal Disclaimer
Forward-Looking Statements and Legal Disclaimer Forward-Looking Statements This presentation contains 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,”
Slide 3: Forward-Looking Statements and Legal Disclaimer (continued)
Forward-Looking Statements and Legal Disclaimer (continued) Additional Information and Where to Find It FLAG has filed with the SEC a registration statement on Form S-4 (as may be amended from time to time, the “Registration Statement”), which includes a definitive proxy statement of FLAG, and a pro
Slide 4: Agenda
Agenda Topic Presenter Calidi Overview Stephen Thesing Strategy Allan Camaisa Oncolytic Viruses, Stem Cells, and IP Antonio F. Santidrian, PhD CLD-101 | NeuroNova Boris Minev, MD CLD-201 | SuperNova Boris Minev, MD Manufacturing Capability Amish Patel, PhD Corporate Governance & Government Affairs W
Slide 5: Executive Team with Proven Track Record
Executive Team with Proven Track Record Boris Minev, Stephen M.D. Allan Camaisa Thesing President, Medical & Chairman & CEO Scientific Affairs, Acting Chief Business Officer CMO Antonio F. Wendy David Sans, Pizarro, Esq. Santidrian, PH.D. PH.D. Chief Administrative Chief Corporate Officer & Chief Le
Slide 6: Board of Directors with Deep Biopharma Expertise
Board of Directors with Deep Biopharma Expertise Allan Camaisa Dr. Heehyoung Lee Chairman of the Board Director Scott Leftwich James Schoeneck Vice Chairman of the Board Director George Ng Alfonso Zulueta Director Director © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and
Slide 7: Calidi Board of Advisors
Calidi Board of Advisors Bernie Fox, Ph.D. Maciej (Matt) S Lesniak, MD Chair, Department of Neurological Surgery © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 7
Slide 8: Calidi Board of Advisors – continued
Calidi Board of Advisors – continued Santosh Kesari, MD, PhD Ewa Carrier, MD Vice President, Clinical Development, FibroGen, Inc. Chair and Professor, Department of Translational Neuro-Oncology and Neurotherapeutics, Saint She has published many high-impact John’s Cancer Institute articles in the ar
Slide 9: First-In-Class Stem Cell Based Platforms to Deliver Oncolytic Payloads
First-In-Class Stem Cell Based Platforms to Deliver Oncolytic Payloads Increase survival rate and therapeutic efficacy in patients suffering targeted delivery of from a wide variety of cancers through allogeneic stem cells loaded with oncolytic viruses (OV) Calidi’s Vision Provide safe and tolerable
Slide 10: Highlights
Highlights Calidi Biotherapeutics is a clinical-stage biopharmaceutical company revolutionizing oncolytic viral therapies with stem cell-based platforms CLD-101: Neural stem cell (NSC) product candidates loaded with oncolytic adenovirus Two Differentiated Stem Cell Platforms 1 CLD-201: Allogeneic Ad
Slide 11: Differentiated Wholly-Owned Pipeline in Multiple Cancer Indications
Differentiated Wholly-Owned Pipeline in Multiple Cancer Indications Multiple partnership opportunities to potentiate and deliver other existing OV’s, combination therapies and joint development of next generation therapies Non-clinical Pivotal Product Platform Target Indications Discovery Phase 1 Ph
Slide 12: Company Strategy
Company Strategy Allan Camaisa Chief Executive Officer & Chairman of the Board
Slide 13: 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 Cell Therapy with OV Calidi is revolutionizing the effective delivery of oncolytic viruses for targeted therapy against difficult-to-treat cancers with an off-the-shelf, potent universal cell-based delive
Slide 14: Calidi's Unique Value Proposition
Calidi’s Unique Value Proposition Overcoming Obstacles to Prior Universal Cancer Therapeutic Generation Oncolytic with Potential to Address a Immunotherapy Wide Range of Solid Tumors Track Record of Successful Solving the Challenge of Non-Dilutive Fundraising Manufacturing with Scalable, through Gov
Slide 15: Key Partners
Key Partners Partnerships with leading cancer organizations provide validation to Calidi’s unique approach, financing to support clinical trials, and deep expertise in oncology © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 15
Slide 16: From Autologous to Allogeneic, developing a Universal Cancer therapy
From Autologous to Allogeneic, developing a Universal Cancer therapy Prior safety study was conducted using autologous stem cells Future studies will be conducted using allogeneic stem cells The Past The Present and Future Autologous Allogeneic Immune Rejection Stealth Low immunogenicity (Stealth) C
Slide 17: Calidi's SuperNova: CLD-201 Pre-Clinical Program
% Cytotoxicity .1 1 10 .1 1 10 100 100 BT-549 BT-549 HS-578T HS-578T Breast Breast MCF7 MCF7 MDA-MB-231 MDA-MB-231 MDAMB468 MDAMB468 SF-268 SF-268 SF-295 SF-295 SF-539 SF-539 CNS CNS SNB-19 SNB-19 SNB75 SNB75 U251 U251 Calidi’s SuperNova: CLD-201 Pre-Clinical Program: Universal Therapeutic HCT-116 H
Slide 18: Calidi Financing Timeline
Calidi Financing Timeline Series B $25M SPAC $3.1M Funds to Date $1M $4M $50M 2015 2016 2017 2018 2019 2020 2021 2022 2023 © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending
Slide 19: Oncolytic Viruses, Stem Cells, and Intellectual Property
Oncolytic Viruses, Stem Cells, and Intellectual Property Antonio F. Santidrian, PhD Senior Vice President, Global Head of R&D
Slide 20: Oncolytic Viruses: Anti-Tumor Mechanisms
ONCOLYTIC VIRUSES: ANTI-TUMOR MECHANISMS Once the OV reaches the tumor it TUMOR cells triggers three distinct anti-tumor mechanisms: 2.DIRECT ONCOLYSIS 3.ANTITUMOR IMMUNITY 1.VASCULAR COLLAPSE (Killing) Activated T cells can now locate, attack and destroy distant tumors. Durable Anti-tumor immunity
Slide 21: Oncolytic Viruses Lead to High Therapeutic Index
Oncolytic Viruses Lead to High Therapeutic Index • Minimal systemic toxicity, toxicity profile non-overlapping with Standard of Care • Mechanism of Action – non- overlapping with Standard of Care • Low probability to generate resistance (not seen so far), target multiple oncogenic pathways • Virus d
Slide 22: Calidi Overcomes the Obstacles to Oncolytic Viral Therapy
Calidi Overcomes the Obstacles to Oncolytic Viral Therapy Challenges with Naked OV Therapy Calidi’s Solution Allogeneic Oncolytic Virus-Loaded Stem Cells Unprotected Oncolytic Virus Stem cell loaded with Active Rapid inactivation Inactivated Stem cell protects Oncolytic Viruses Oncolytic by immune O
Slide 23: Induction of Anti-Tumor Immune Response
Induction of Anti-Tumor Immune Response 2. ANTIGEN PRESENTING 1. TUMOR CELL CELLS PROCESS AND RELEASES TARGET PRESENT ANTIGENS TO T ANTIGENS CELLS 4. ACTIVATED T CELLS INACTIVE CAN NOW DETECT T CELL AND DESTROY 3. T-CELL INITIATES ACTIVATED DISTANT TUMORS ACTIVATION AND T CELL PROLIFERATION CALIDI’S
Slide 24: Allogeneic Stem Cell Platforms
Allogeneic Stem Cell Platforms CLD-101 and CLD-201 use oncolytic viruses loaded into stem cells • Possess an inherent ability to distribute throughout a brain tumor mass as well as migrate to distant tumor sites Neural Stem Cells (NSC) regardless of tumor size, anatomic location, or tissue type • CL
Slide 25: Calidi's Platform Advantages
Calidi’s Platform Advantages Cell Protected: Oncolytic Virus Herpes Virus Vaccinia Virus Herpes Virus Adenovirus Vaccinia Virus Platform Adenovirus Engineered Virus ✔ ✔ ✔ ✔ ✔ FDA Approved Virus X ✔ X X X Reduced viral elimination by the ✔ X X X X immune system Virally-encoded therapeutic expressed ✔
Slide 26: Maximizing Therapeutic Responses with Directed Localized Administration
Maximizing Therapeutic Responses with Directed Localized Administration CLD-101 Directed – Localized administration (Neuronova) ü High therapeutic index of treated lesion/areas ü Low toxicity CLD-201 ü Strong activation of local and systemic antitumor (Supernova) immunity ü In situ vaccination ü Eff
Slide 27: Broad IP Protection Across All Clinical Programs in Development
Broad IP Protection Across All Clinical Programs in Development Allogeneic Adipose Tissue-derived and Neural Stem Cell Platforms for Delivery of Oncolytic Viruses Tropic Cell-Based Two US Issued Virotherapy for the Use of Neural Stem Cells to Deliver Oncolytic Adenovirus Patents, One Pending Treatme
Slide 28: CLD-101 (NeuroNova)
CLD-101 (NeuroNova) Boris Minev, MD President, Medical & Scientific Affairs
Slide 29: High-Grade Glioma: Common and Difficult to Treat
High-Grade Glioma: Common and Difficult to Treat US Glioblastoma New Diagnoses 13,400 13,200 13,000 12,800 12,600 12,400 Sen. John McCain Sen. Ted Kennedy Beau Biden 12,200 12,000 • Glioblastoma market to reach $10.2B in 2030 with an 11,800 anticipated CAGR of 12.8% during forecast period 21-30 11,6
Slide 30: High-Grade Gliomas
High-Grade Gliomas High-Grade Gliomas have the most rapid tumor progression rate of any glioma, with poor survival rates 5-Year Relative Survival Rate of Patients with High-Grade Gliomas Age 20-44 45-54 55-64 64+ 5-Year Survival Rate 22% 9% 6% <6% Standard of Care was developed 18 years ago, and ess
Slide 31: CLD-101: Platform Overview
CLD-101: Platform Overview Adenovirus (CRAd-S-pk7) for CLD-101 Amplifies selectively in tumor cells Radiation treatment upregulates Survivin expression Ø Possess an inherent ability to distribute throughout a brain tumor mass as well as migrate to distant tumor sites regardless of tumor size, anatom
Slide 32: CLD-101: Significant Published Clinical Results
CLD-101: Significant Published Clinical Results Neural Stem Cell Delivery of an Oncolytic Adenovirus in Newly Diagnosed Patients with Malignant Glioma: A First-in-Human, Phase 1 Clinical Trial (Lancet Oncology, 2021 Aug;22(8):1103-1114) Agent: CLD-101 (NSC-CRAd-S-pk7): Neural stem cells loaded with
Slide 33: CLD-101: Significant Published Clinical Results
CLD-101: Significant Published Clinical Results • Treatment with CLD-101 (NSC-CRAd-S-pk7) was safe and tolerable • Treatment achieved favorable therapeutic outcomes in patients with newly diagnosed malignant glioma: best overall response saw one patient responding partially to treatment, another pro
Slide 34: CLD-101: Clinical Trial Results in Newly-diagnosed High Grade Glioma
CLD-101: Clinical Trial Results in Patients with Newly-diagnosed High Grade Glioma Patient Demographics Tumor Type Tumor Criteria N (N=12) % Demographic Criteria N (N=12) % 18-29 1 8 Wild type 10 83.3 40-49 3 25 IDH1 mutant 2 16.7 IDH1/2 status Age (years) 50-59 3 25 IDH2 mutant 0 0 60-69 4 33 70-79
Slide 35: CLD-101: Ongoing Trial in Patients with Recurrent High-Grade Glioma
CLD-101: Ongoing Trial in Patients with Recurrent High-Grade Glioma Ongoing Phase 1 trial at City of Hope Indication: Recurrent High-Grade Glioma First Patient In: Q2 2023 © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 35
Slide 36: CLD-101: Planned Trial in Patients with Newly-diagnosed High-Grade Glioma
CLD-101: Planned Trial in Patients with Newly-diagnosed High-Grade Glioma Planned Phase 1b/2 Trial at Northwestern University Indication: Newly-Diagnosed High-Grade Glioma T1 First Patient In: 1H 2024 © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 36
Slide 37: CLD-201 (SuperNova)
CLD-201 (SuperNova) Boris Minev, MD President, Medical & Scientific Affairs
Slide 38: Solid Tumors: Significant Total Addressable Market
Solid Tumors: Significant Total Addressable Market Global Solid Tumors Market Growth U.S. Estimated Addressable Market – Solid Tumors Tumor Type U.S. Annual Incidence U.S. Annual Deaths 600 NSCLC - Squamous 59,500 33,500 CAGR: 500 NSCLC – Adeno 79,500 44,600 11.09% SCLC 33,000 22,500 400 Breast 287,
Slide 39: Calidi's Oncolytic Vaccinia Virus CAL1
Calidi’s Oncolytic Vaccinia Virus CAL1 Vaccinia Virus Advantages: • Not a human pathogen • Safely used as a vaccine for smallpox • Key natural attenuations improve tumor selectivity • Highly cytolytic for most tumor types • Large insertion capacity allows cloning of therapeutic payloads © 2023 Calid
Slide 40: Completed study with Autologous Stem Cells loaded with the CAL1 Virus
Completed study with AUTOLOGOUS Stem Cells loaded with the CAL1 Virus Trial Results: Combined application of Stem cells and CAL1 virus was well-tolerated in all patients The results of the plasma cytokine assays suggested inflammatory reaction starting approximately 1 week after treatment. No cytoki
Slide 41: Durable Tumor Regression and Survival
Durable Tumor Regression and Survival Calidi Autologous Study: Positive Results in Combination With Checkpoint Inhibitor • Stage IV_B • Age/Sex: 70/M • Injected tumor was previously resistant to chemo- and radio-therapy • Diagnosis: Metastatic Head & Neck SCC Patient Case: Patient #SI01-021 Day 194
Slide 42: Durable Tumor Regression and Survival (continued)
Durable Tumor Regression and Survival (continued) • Age/Sex: 68/M • Diagnosis: Thyroid Papillary Carcinoma • Stage IV Patient Case: Patient #SI01-047 Day 85 post-treatment: tumor Day 30 post-treatment Day 65 post-treatment has fully regressed Primary objective - Safety: There were no treatment-relat
Slide 43: Calidi's next generation product: CLD-201 Allogeneic Stem Cells loaded with CAL1
Calidi’s next generation product: CLD-201 – ALLOGENEIC Stem Cells loaded with the CAL1 Virus ADVANTAGES of Using Allogeneic Stem Cells: IMPROVED POTENCY: larger number of viral particles inside the stem cells BETTER REPRODUCIBILITY: CLD-201 product is composed of cultured and expanded mesenchymal st
Slide 44: Development of Allogeneic Cell-Based Product VP-001
Development of Allogeneic Cell-Based Product VP-001 GMP master cell bank p2 Calidi owns 8 allogeneic adult adipose (AAA)-derived stem cell (AD-MSC) banks + 1 NSC proliferation/scalability profile Allogeneic GMP Master cell bank p2 (VP01), is used in several clinical trials to treat patients with COV
Slide 45: Advantages of Calidi's Technology
Advantages of Calidi’s Technology Vaccinia virus (VACV) engineered to express red fluorescent protein. RED signal indicates virus amplification leading to killing of cancer cells Treatment: CAL1 – naked virus Treatment: CAL1 - naked virus Treatment: CAL1 + AD-MSC PC3 (prostate cancer) PC3 (prostate
Slide 46: CLD-201: Improved efficacy in tumor models in vivo
CLD-201: Improved efficacy in tumor models in vivo Stem cells (AD-MSCs) increase therapeutic efficacy in mouse models of CAL1-vaccinia virus in vivo after intra- tumoral administration CT26 PC3 © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 46
Slide 47: CLD-201: Therapeutic Response in Different Mouse Models
CLD-201: Therapeutic Response in Different Mouse Models Cell Line Cancer Type Growth Inhibition Models B16-F10 Melanoma 78% Syngeneic EMT-6 Breast 69% Syngeneic CT-26 Colon 77% Syngeneic Tramp-C2 Prostate 99% Syngeneic RM-1 Prostate 57% Syngeneic PC3 Prostate 59% Xenograft MDA-MB-231 Breast 98% Xeno
Slide 48: CLD-201: Intratumoral administration induces systemic therapeutic response
CLD-201: Intratumoral administration induces significant systemic therapeutic response (abscopal effect) Bilateral tumor-bearing colon cancer (CT26) mouse model. CAL1 (naked) CLD-201 (+ stem cells) Distant tumor Left untreated Ø Only 1 tumor was treated. Ø Therapeutic response was followed in both t
Slide 49: CLD-201: Local administration induced robust immune cell infiltration
CLD-201: Local administration induced both robust local and systemic immune cell infiltration CD4 Teffs/ Tregs CD4 (T cells) CD8 (T cells) Tregs CD8/Treg Control Treatment Control Treatment Control Treatment Control Treatment Control Treatment Groups were compared by unpaired two-tailed T-test (*P <
Slide 50: CLD-201: Development Pathway
CLD-201: Development Pathway Pre-IND meeting held Next Steps cGMP Final Drug Product Manufacturing to be completed in 1Q 2024, Phase 1 clinical trial initiation in 2H 2024: A Phase 1/2 study of intra-tumoral administration of CLD-201, alone or in combination with checkpoint inhibitors, in patients w
Slide 51: CLD-201: Planned Clinical Development
CLD-201: Planned Clinical Development A Phase 1/2 study of intra-tumoral administration of CLD-201, alone or in combination with checkpoint inhibitors, in patients with advanced metastatic solid tumors Part 1: Dose Escalation • Classical 3+3 trial design. Three dose levels will be tested, alone or i
Slide 52: Clinical and Commercial Manufacturing and Supply Chain
Clinical and Commercial Manufacturing and Supply Chain Amish Patel, PhD VP, Technical Operations
Slide 53: Manufacturing and Supply Chain: Overview
Manufacturing and Supply Chain: Overview First in Class stem cell loaded oncolytic virus therapy platform with successful GMP production • Scalable, cost-efficient manufacturing platform • GMP-grade adipose-derived allogeneic stem cell bank and Virus banks sufficient to support clinical and commerci
Slide 54: Manufacturing activities for CLD-101 (NeuroNova NNV)
Virus amplification Manufacturing activities for CLD-101 (NeuroNova NNV) CLD-101 (NNV): Neural stem cells (NSC) delivering CRAd-s-pk7 oncolytic Adenovirus Virus Seed Master Virus Seed Virus amplification CRAd-s-pk7 oncolytic Stock (MVSS) Adenovirus CRAd-s-pk7 Master Cell Bank (MCB) A549 Virus host c
Slide 55: Manufacturing activities for CLD-201 (SuperNova SNV)
Virus amplification Manufacturing activities for CLD-201 (SuperNova SNV) CLD-201 (SNV): Adipose-derived MSC (AD-MSC) delivering oncolytic Vaccinia Virus CAL1 Master Virus Bank Virus amplification Virus Seed (MVB) Vaccinia Virus CAL1 Vaccina Virus CAL1 Master Cell Bank (MCB) CV-1 Virus host cell line
Slide 56: Roadmap to Phase and commercialization: CDMO selection progress
Roadmap to Phase 2 and commercialization: CDMO selection progress Preclinical development Phase 1 Phase 2/Phase 3/Commercial Development 2025 onwards Timeline 2021 2022 2023 2024 Today GMP Production at CDMO Current CDMO vendors Initiate new CDMO Commercial-ready process Pilot/GMP drug product batch
Slide 57: Corporate Governance & Government Affairs
Corporate Governance & Government Affairs Wendy Pizarro Chief Legal Officer
Slide 58: Commitment to Diversity, Equity & Inclusion in Clinical Trials
Commitment to Diversity, Equity & Inclusion in Clinical Trials Increase under-represented communities in clinical trials • For Example: Non-Hispanic Black women are disproportionately burdened with the highest breast cancer death rates in Los Angeles (18%). Strategic Planning – Education, Access and
Slide 59: CIRM Grants Awarded Supporting Calidi's Lead Programs
CIRM Grants Awarded Supporting Calidi’s Lead Programs Grant type: CLIN2 - Clinical Trial Stage Program $12 Granted to: City of Hope (PI: Dr. Portnow) Million Product: CLD-101 (NNV2) Objective: Support Phase 1 clinical trial in Recurrent High-Grade Glioma Dec. ‘22 Grant type: CLIN1 – Late-Stage Pre-c
Slide 60: Finance
Finance Tony Kalajian Chief Financial Officer
Slide 61: Financials and Timing of Filings
Financials and Timing of Filings ØMarcum LLP engaged as new auditor effective November 2022 ØPCAOB/SEC compliant audits of FY2022 and FY2021 consolidated financial statements completed ØInterim period Q1 2023 review completed and signed off included in the S-4 A/3 filed ØQ2 2023 interim period finan
Slide 62: The Path Forward
The Path Forward Allan Camaisa Chief Executive Officer & Chairman of the Board
Slide 63: Rapidly Growing OV Market With High Unmet Medical Needs
Rapidly Growing OV Market With High Unmet Medical Needs Large total addressable Rapidly growing OV market Differentiated technology market with high unmet needs with early signals of efficacy • Large total addressable • Additional data needed to market across current show clinical differentiation 20
Slide 64: Initial Target Indications Have a U.S. Estimated Annual TAM of $9B+
Initial Target Indications Have a U.S. Estimated Annual TAM of $9B+ Calidi U.S. total addressable market (2022E) Estimates do not account for treatment rate, Billions of USD physician prescribing behavior, competition • Assuming annual pricing similar to other or other correction adjustments 12 I/O
Slide 65: Upcoming Key Milestones: 2023 & 2024
Upcoming Key Milestones: 2023 & 2024 2023 2024 1H 2H 1H 2H First patient dosed CLD-101 CLD-101 (NNV1) (NNV1) First patient Interim Clinical trial CLD-101 dosed CLD-101 results CLD-101 (NNV2) (NNV2) (NNV2) First patient dosed CLD-201 cGMP Final Drug CLD-201 (SNV1) Product (SNV1) Manufactured Anticipa
Slide 66: Review of Highlights
Review of Highlights Calidi Biotherapeutics is a clinical-stage biopharmaceutical company revolutionizing oncolytic viral therapies with stem cell-based platforms CLD-101: Neural stem cell (NSC) product candidates loaded with oncolytic adenovirus Two Differentiated Stem Cell Platforms 1 CLD-201: All
Slide 67: Thank You
Thank You Contact: Stephen Thesing sthesing@calidibio.com Exhibit 99.2 FLAG STOCKHOLDERS: REMINDER TO VOTE FOR PROPOSED BUSINESS COMBINATION RESTON, Va. — August 16, 2023 — First Light Acquisition Group, Inc. (“FLAG”) (NYSE American: FLAG), a special purpose acquisition company, reminds FLAG stockho