Calidi Biotherapeutics, Inc. · AMEX:CLDI
Calidi Biotherapeutics — SPAC Merger (January 2023)
25 slides from Calidi Biotherapeutics's SPAC merger presentation, Jan 9, 2023
Slide 1: Revolutionizing Cancer Therapies with a Durable and Systemic Antitumor Immune Response
January 2023 www.calidibio.com Revolutionizing Cancer Therapies with a Durable and Systemic Antitumor Immune Response Utilizing Allogeneic Ethical Stem Cell-Based Platforms to Deliver and Potentiate Oncolytic Therapies Exhibit 99.2
Slide 2: Forward-Looking Statements and Legal Disclaimer
Forward-Looking Statements and Legal Disclaimer Page 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 (“F
Slide 3: Forward-Looking Statements and Legal Disclaimer (continued)
Forward-Looking Statements and Legal Disclaimer (continued) Page 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 an
Slide 4: First-In-Class Allogeneic Stem Cell Based Oncolytic Platforms
First-In-Class Allogeneic Stem Cell Based Oncolytic Platforms Page 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) Provide safe and tolerable therapeutic options
Slide 5: Synergistic Teams: First Light Acquisition Group & Calidi Biotherapeutics
Synergistic Teams: First Light Acquisition Group & Calidi Biotherapeutics Page Public Market Experience and Readiness Commercially Viable Manufacturing Multiple Revenue Sources with Significant Partnership Opportunities First-in-Class Allogeneic Stem Cell-Based Platforms to Deliver and Potentiate On
Slide 6: Key Transaction Terms
Key Transaction Terms Page Excludes earn-out of the existing Calidi shareholders and redemption recapture shares. Excludes the impact from potential dilution from FLAG public warrants and private placement warrants or any potential new awards under any combined company new equity incentive plan. Inc
Slide 7: Executive Team with Proven Track Record
Executive Team with Proven Track Record Allan Camaisa Chairman & CEO Boris Minev, M.D. President, Medical & Scientific Affairs, Acting CMO Antonio Santidrian, PH.D. SVP, Global Head of R&D Stephen Thesing Chief Business Officer Wendy Pizarro, Esq. Chief Administrative Officer & Chief Legal Officer A
Slide 8: Board of Directors with Deep Biopharma Expertise
Board of Directors with Deep Biopharma Expertise Page Dr. Heehyoung Lee Director James Schoeneck Director Alfonso Zulueta Director Allan Camaisa Chairman of the Board Scott Leftwich Vice Chairman of the Board George Ng Director
Slide 9: Calidi Board of Advisors
Calidi Board of Advisors Maciej (Matt) S Lesniak, MD Chair, Department of Neurological Surgery Bernie Fox, Ph.D. Page
Slide 10: Calidi Overcomes the Obstacles to Oncolytic Viral Therapy
Page Unprotected Oncolytic Virus Active Oncolytic Viruses Rapid inactivation by immune system Inactivated Oncolytic Viruses Challenges with Naked OV Therapy Naked oncolytic viruses are quickly eliminated by the patient’s immune system, leading to limited therapeutic potential Calidi’s Solution Stem
Slide 11: Differentiated, Wholly-Owned Pipeline Targeting Multiple Cancer Indications
Differentiated, Wholly-Owned Pipeline Targeting Multiple Cancer Indications Multiple partnership opportunities to potentiate and deliver other existing OV’s, combination therapies and joint development of next generation therapies Cancer indications Product Program Target Indications Discovery Non-c
Slide 12: First-in-Class Platform With Significant Growth Potential
First-in-Class Platform With Significant Growth Potential Page Calidi’s allogeneic stem cell-based delivery platform enables scalable licensing model, driving revenue opportunities Potential to license stem-cell based delivery platform to develop new therapies targeting cancers with significant unme
Slide 13: Rapidly Growing OV Market With High Unmet Medical Needs
Rapidly Growing OV Market With High Unmet Medical Needs Page Sources: (*) Oncolytic Virus Immunotherapy Market Size is Predicted to Hit US$ 2.4 Billion by 2030 | BioSpace (**) Types of Cancer | Cancer.Net (***) Oncology Cancer Drugs Market Size is projected to reach USD (globenewswire.com) 6-8 appro
Slide 14: Calidi's Target Indications with Estimated Annual TAM of $9B+
Calidi’s Target Indications with Estimated Annual TAM of $9B+ Page Sizable TAM given Calidi’s target indications (Melanoma, TNBC, GBM,H&N) Sources: (*) Cancer Types | Cancer Resources | American Cancer Society $9-11B $3.5-4.5B $2-2.5B $2.5-3.5B $0.5-1B Projected Patients Calidi U.S. total addressabl
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 Trial Objectives: To determine the safety and toxicity profile and the maximum tolerated dose To determine the best tumor response using the iRANO criteria, estimate survival outcomes in patients and evaluate quality of life while on treatm
Slide 17: Neural Stem Cell Delivery of an Oncolytic Adenovirus in Newly Diagnosed Malignant Glioma
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 CRAd-S-pk7 - a chimeric adenoviral vector contai
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 Potentiate Oncolytic Viruses Our immortalized stem cell line is scalable, allogeneic, off-the-shelf and universal. No need to change donor
Slide 19: CLD-201: SuperNova Platform: Allogeneic Stem Cells loaded with CAL1 Virus
CLD-201: SuperNova Platform: Allogeneic Stem Cells loaded with CAL1 Virus Successfully determined the safety and toxicity profile and the maximum tolerated dose Successfully determined the best tumor response, estimated survival outcomes in patients and evaluated quality of life while on treatment S
Slide 20: Patient Case: Patient #SI01-021
Patient Case: Patient #SI01-021 Day 52 post-treatment Day 194 post-treatment: complete response Age/Sex: 70/M Diagnosis: Metastatic Head & Neck SCC Stage IV_B Injected tumor was previously resistant to chemo- and radio-therapy Day 17 post-treatment Day 45 post-treatment Durable Tumor Regression and
Slide 21: Patient Case: Patient #SI01-047
Patient Case: Patient #SI01-047 Age/Sex: 68/M Diagnosis: Thyroid Papillary Carcinoma Stage IV Day 85 post-treatment: tumor has fully regressed Day 30 post-treatment Day 65 post-treatment Durable Tumor Regression and Survival Autologus SuperNova: Positive Results in Combination With Checkpoint Inhibi
Slide 22: CLD-201: SuperNova Development Pathway
CLD-201: SuperNova Development Pathway Page 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, Phase 1 initiation in 2H 2023 CLD-20
Slide 23: New manufacturing protocols offer potential to generate quadrillions of doses of stem cells
New manufacturing protocols offer the potential to generate quadrillions of doses of stem cells from a single donor 1 single donor can be used for multiple indications, clinical development programs and commercialization Calidi owns 8 allogeneic adult adipose (AAA)-derived stem cell (AD-MSC) banks +
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 Virotherapy for the Treatment of Cancer Smallpox Vaccine for Treatment of Cancer Combination Immunotherapy Approach for
Slide 25: Two Differentiated Stem Cell Platforms Large Target Markets in Areas of High Unmet Need
Two Differentiated Stem Cell Platforms Large Target Markets in Areas of High Unmet Need Cutting Edge Stem Cell Manufacturing Processes Three Clinical Development Programs Page 1 2 4 3 CLD-101: Neural stem cell (NSC) product candidates loaded with oncolytic adenovirus CLD-201: Allogeneic Adipose-deri