Calidi Biotherapeutics, Inc. · AMEX:CLDI
Calidi Biotherapeutics — SPAC Merger (February 2023)
25 slides from Calidi Biotherapeutics's SPAC merger presentation, Feb 10, 2023
Slide 1: Revolutionizing Cancer Therapies with a Durable and Systemic Antitumor Immune Response
Exhibit 99.1 Revolutionizing Cancer Therapies with a Durable and Systemic Antitumor Immune Response Utilizing Allogeneic Stem Cell-Based Platforms to Deliver and Potentiate Oncolytic Therapies www.calidibio.com February 2023
Slide 2: Forward-Looking Statements and Legal Disclaimer
Forward-Looking Statements and Legal Disclaimer Presentation Disclaimer This presentation (the “Presentation”) is for informational purposes only with respect to the proposed business combination between First Light Acquisition Group, Inc., a Delaware special purpose acquisition corporation (“FLAG”)
Slide 3: Forward-Looking Statements and Legal Disclaimer (continued)
Forward-Looking Statements and Legal Disclaimer (continued) Factors that may cause actual results to differ materially from current expectations include, but are not limited to: the occurrence of any event, change or other circumstances that could give rise to the termination of negotiations and any
Slide 4: First-In-Class Allogeneic Stem Cell Based Oncolytic Platforms
First-In-Class Allogeneic Stem Cell Based Oncolytic Platforms Increase survival rate and therapeutic efficacy in patients suffering from a wide variety of cancers through targeted delivery of allogeneic stem cells loaded with oncolytic viruses (OV) Calidi’s Vision Provide safe and tolerable therapeu
Slide 5: Synergistic Teams: First Light Acquisition Group & Calidi Biotherapeutics
Synergistic Teams: First Light Acquisition Group & Calidi Biotherapeutics Accelerating the ability to bring life-changing therapies to market more quickly with first-in-class technology and strategic partnering opportunities Vast Public Decades of Seeking Sector Operating and Significant Experience,
Slide 6: Transaction Overview
Transaction Overview Key Transaction Terms Redemption Scenarios (2) Total gross proceeds from Transaction, before payment of transaction expenses, expected to be up Illustrative Pro Forma Valuation 0% 75% to $82 million assuming no redemptions, combining a possible PIPE financing of up to $40 millio
Slide 7: Executive Team with Proven Track Record
Executive Team with Proven Track Record David Sans, George Ng PH.D. Allan Camaisa President & Chief Chairman & CEO Chief Corporate Operations Officer Development Officer Boris Minev, Wendy Stephen M.D. Pizarro, Esq. Thesing President, Medical & Chief Administrative Scientific Affairs, Acting Officer
Slide 8: 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 Page © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issue
Slide 9: Calidi Board of Advisors
Calidi Board of Advisors Bernie Fox, Ph.D. Maciej (Matt) S Lesniak, MD Chair, Department of Neurological Surgery Page © 2023 Calidi Biotherapeutics, Inc. І Company Proprietary; Patents issued and pending 9
Slide 10: 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 11: Differentiated, Wholly-Owned Pipeline Targeting Multiple Cancer Indications
Differentiated, Wholly-Owned Pipeline Targeting Multiple Cancer Indications Non-clinical Pivotal Product Platform Target Indications Discovery Phase 1 Phase 2 Partner studies Trial Newly Diagnosed High Entering Phase 1b/2 Grade Glioma CLD-101 NeuroNova Recurrent High Grade Entering Phase 1 Glioma Ad
Slide 12: First-in-Class Platform With Significant Growth Potential
First-in-Class Platform With Significant Growth Potential Calidi’s allogeneic stem cell-based delivery platform enables scalable licensing model, driving revenue opportunities Accelerated R&D stage, expedited time to market Broad application: Platform compatible with numerous oncolytic viruses CLD-1
Slide 13: Rapidly Growing OV Market With High Unmet Medical Needs
Rapidly Growing OV Market With High Unmet Medical Needs Differentiated technology with early signals of Large total addressable market across current efficacy; additional data needed to show clinical indications of focus: Melanoma, GBM, TNBC, H&N differentiation vs. competitor base ~56k patients acr
Slide 14: Calidi's Target Indications with Estimated Annual TAM of $9B+
Calidi’s Target Indications with Estimated Annual TAM of $9B+ Sizable TAM given Calidi’s target indications (Melanoma, TNBC, GBM,H&N) $3.5-4.5B $9-11B Calidi U.S. total addressable market (2022E) $2-2.5B Billions of USD $2.5-3.5B $0.5-1B Projected ~3.6K ~17K ~12K ~23K ~56K Patients Assuming annual p
Slide 15: HGG - Most Common and Aggressive Brain Cancer
HGG - Most Common and Aggressive Brain Cancer at Age 60 Survival rates for patients with High Grade Glioma (HGG) have shown no improvement in the last 30 yrs. 24,500 patients were diagnosed in the US with tumors of the central nervous system in 2022, 48% of the patients will be advanced HGG (Gliobla
Slide 16: CLD-101: NeuroNova Platform Overview & Phase Trial Design
CLD-101: NeuroNova Platform Overview & Phase 1 Trial Design Adenovirus (CRAd-S-pk7) for NeuroNova Amplifies selectively in HGG tumor cells Radiation treatment upregulates Survivin expression Trial Objectives: To determine the safety and toxicity profile and the maximum tolerated dose To determine th
Slide 17: 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 18: CLD-101: Highlights of First-in-Class NeuroNova1 Platform for HGG
CLD-101: Highlights of First-in-Class NeuroNova1 Platform for HGG Reasons to Believe Reasons to Advance Reasons for Speed Neural Stem Cells Deliver, Protect and Our immortalized stem cell line is Malignant High-Grade-Glioma (HGG) is the Potentiate Oncolytic Viruses scalable, allogeneic, off-the-shel
Slide 19: CLD-201: SuperNova Platform: Allogeneic Stem Cells loaded with CAL1 Virus
CLD-201: SuperNova Platform: Allogeneic Stem Cells loaded with CAL1 Virus Vaccinia Virus (CAL1) for SuperNova Not a serious 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 cl
Slide 20: Durable Tumor Regression and Survival: Autologous SuperNova
Durable Tumor Regression and Survival Autologous SuperNova: Positive Results in Combination With Checkpoint Inhibitor • Age/Sex: 70/M • Diagnosis: Metastatic Head & Neck SCC • Stage IV_B • Injected tumor was previously resistant to chemo- and radio-therapy Patient Case: Patient #SI01-021 Day 194 pos
Slide 21: Durable Tumor Regression and Survival: Autologous SuperNova
Durable Tumor Regression and Survival Autologus SuperNova: Positive Results in Combination With Checkpoint Inhibitor • Age/Sex: 68/M • Diagnosis: Thyroid Papillary Carcinoma • Stage IV Patient Case: Patient #SI01-047 Day 85 post-treatment: Day 30 post-treatment Day 65 post-treatment tumor has fully
Slide 22: CLD-201: SuperNova Development Pathway
CLD-201: SuperNova Development Pathway Pre-IND meeting held 2Q 2021 Next Steps CLD-201 – (allogeneic AD-MSC-delivering CAL1 oncolytic virus) Phase 1 study for the treatment of solid tumors (metastatic breast/ melanoma/head and neck) cGMP Final Drug Product Manufacturing to be completed in 3Q 2023, P
Slide 23: Development of Allogeneic Cell-Based Product
Development of Allogeneic Cell-Based Product Calidi owns 8 allogeneic adult adipose (AAA)-derived stem cell (AD-MSC) banks + 1 NSC Allogeneic GMP Master cell bank p2 (VP01), is used in several clinical trials to treat patients with COVID-19-induced acute respiratory distress syndrome (ARDS) (Pivotal
Slide 24: 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 25: Investment Highlights
Investment 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: Al