CERo Therapeutics Holdings, Inc. · OTC:CERO
CERo Therapeutics — Phoenix Biotech Acquisition — SPAC Merger (August 2023)
46 slides from CERo Therapeutics's SPAC merger presentation, Aug 14, 2023
Slide 1: The Next Era in Cell Therapy
The Next Era in Cell Therapy A u g u s t 2 0 2 3
Slide 2: Disclaimers and Other Important Information
Disclaimers and Other Important Information 2 This presentation (this “Presentation”) is provided for informational purposes only and for no other purpose and has been prepared to assist interested parties in making their own evaluation with respect to a potential business combination by and among C
Slide 3: Disclaimers and Other Important Information: Forward-Looking Statements
Disclaimers and Other Important Information 3 Forward - Looking Statements Certain statements included in this Presentation are not historical facts but are forward - looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 199
Slide 4: Overview
• First - in - Class cell therapy candidate for cancer, combining Phagocytosis and Tumor Cell Lysis in a single engineered T Cell • Targets a unique cell surface “Eat Me” ligand – Phosphatidylserine – upregulated on tumors • Demonstrated tumor - killing in NSCLC, Ovarian Cancer, MCL and AML – all tu
Slide 5: A Simple Idea Became a Novel, Powerful Therapeutic
A Simple Idea Became a Novel, Powerful Therapeutic Engineering Engulfment into T Cells 5
Slide 6: T Cells Are the Right Chassis
• Lysis, tumor cell apoptosis • Proliferation and serial killing • Trafficking to tumors • Release of anti - tumor cytokines • Persistence and memory formation • 20+ years of research and clinical experience • 10+ years of manufacturing expertise • FDA experience, familiarity and comfort T Cells Are
Slide 7: Phosphatidylserine (PS) – The Right Target
• PS is a pro - phagocytic “Eat Me” signal that triggers cell removal by macrophages • Cell surface PS is significantly upregulated on apoptotic cells, virally infected cells, under cell stress conditions, or on tumor cells • Resides in the internal lipid bilayer of normal healthy cells – normal exp
Slide 8: CER-T Cells Designed to Eliminate the Entire Tumor
CER - T Cells Designed to Eliminate the Entire Tumor Tumor Cell PS CER CER - T Cell Chimeric engulfment receptor T cells (CER - T) binds to phosphatidylserine (PS), the “eat me” signal on tumor cell 8 BIND
Slide 9: CER-T Cells Designed to Eliminate the Entire Tumor
CER - T Cells Designed to Eliminate the Entire Tumor Tumor Cell PS CER CER - T Cell Peptide processing and presentation Tumor cell fragments ENGULFMENT Chimeric engulfment receptor T cells (CER - T) binds to phosphatidylserine BIND Binding to PS mediates the capture and uptake of tumor cell fragment
Slide 10: CER-T Cells Designed to Eliminate the Entire Tumor
Tumor Cell PS CER CER - T Cell Peptide processing and presentation MHC I MHC II Helper T cells Cytotoxic T cells ADAPTIVE Immune Responses Tumor cell fragments ENGULFMENT CER - T Cells Designed to Eliminate the Entire Tumor Chimeric engulfment receptor T cells (CER - T) binds to phosphatidylserine B
Slide 11: CER-T Cells Designed to Eliminate the Entire Tumor
Chimeric engulfment receptor T cells (CER - T) binds to phosphatidylserine Binding to PS mediates the capture and uptake of tumor cell fragments, Tumor cell phagocytosis leads to efficient tumor antigen capture, CER - T Cells Designed to Eliminate the Entire Tumor BIND EAT PRESENT Intracellular sign
Slide 12: In Vivo Evidence of Anti-Tumor Killing
0 10 40 50 20 30 Days post T cell infusion 0 500 1000 1500 2000 Tumor Volume (mm 3 “ SEM) CER T cells In Vivo Evidence of Anti - Tumor Killing 12 A Single Infusion of CER - T Cells EGFR - mutant NSCLC cells Robust anti - tumor in vivo responses across solid and hematologic models Single infusion of
Slide 13: Highlights
IND and clinical signal expected within investment timeframe GROUNDBREAKING BIOLOGY Powerful multi - modal approach to eliminating the entire tumor PREPARING FOR THE CLINIC Process development and pre - IND meeting completed, going into liquid tumors and potentially solid tumors (complete data set i
Slide 14: Management team
Brian Atwood Chief Executive Officer • Co - founder, President and CEO of Cell Design Labs (acquired by Gilead in 2017) • Chair, Phoenix Biotech Acquisition Corp • Former Chair, Locust Walk Acquisition Corp (NASD: LWAC) • Managing Director of Versant Ventures, co - founder in 1999 • Director and Cha
Slide 15: CAR-T Has Been Transformative, but Challenges Persist
CAR - T Has Been Transformative, but Challenges Persist Tumor Escape Myeloid Dysfunction THE CONSEQUENCE Limited widespread use Antigen Heterogeneity T Cell Exhaustion Tumor Microenvironment Suppression Ineffective in Solid Tumors 15
Slide 16: Phagocytosis by TIM-Receptor
Phagocytosis by TIM - 4 Receptor CERo has observed TIM - 4 - mediated phagocytosis in CER - T cells Tumor Cell CER - T Cell • A natural phagocytic receptor • Involved in clearing billions of unwanted cells each second in our body • Acquires tumor associated antigens to activate anti - tumor response
Slide 17: What is a CER-T cell?
What is a CER - T cell? himeric ngulfment eceptor C E R Uses TIM - 4 Phagocytic Receptor to Engage Tumor Targets via the Cell of Damaged Receptor Phosphatidylserine (PS) Tumor Cell PS Tumor Cell CER - T Cell Multifunctional Construct Transmembrane Extracellular Domain Tumor binding and phagocytosis
Slide 18: AMLs Upregulate the Eat Me Signal Phosphatidylserine
20 0 40 60 80 100 % Target Positive 18 Acute Myeloid Leukemias Upregulate the “Eat Me” Signal Phosphatidylserine TIM - 4 binding Normalized to Mode Treatment naïve AML BMMC Healthy BMMC AML + Therapy AML Upregulation of Cell - surface “Eat Me” Target Across AML Subtypes High Levels of ”Eat Me” Targe
Slide 19: Ovarian tumor samples TIM-4 binding
Age at Surgery Histology Stage Grade Type of Chemotherapy Chemo Regimen Tumor Site Tumor % pos for TIM - 4 Binding 52 High grade serous 3c 3 Neoadjuvant Carboplatin + Taxol Left ovary 90 54 High grade serous 4 3 Neoadjuvant Carboplatin + Taxol Right ovary 90 57 Clear cell 1a1 3 None N/A Left ovary 9
Slide 20: Multi-modal approach to tumor cell sensing, killing, and elimination
20 Multi - modal approach to tumor cell sensing, killing, and elimination Combining the body’s natural clearance machinery with enhanced T cell cytotoxic effects can amplify the body’s anti - tumor response MORE POTENT MORE DURABLE LOW OBSERVED TOXICITY Favorable potential toxicity profile is quiete
Slide 21: Optimizing the Therapeutic - What We Learned
Optimizing the Therapeutic - What We Learned Serial killing, high proliferative capacity, and multi - functionality Absence of auto - activation, or premature exhaustion Preservation of naïve and memory phenotype Distinct transcriptome, cytokine, and chemokine repertoire Enhanced antigen acquisition
Slide 22: Empowered T Cells with Phagocytic Potency
Tumor elimination via target - dependent phagocytosis Phagocytosis (%) CER - 1236 Empowered T Cells with Phagocytic Potency Untransduced CER - 1236 Mutant TIM - 4 CER - 1251 CER T cell Tumor cell Phagocytosis NSCLC 22 Molecular Therapy, 2023 May 16. PMID: 37194236.
Slide 23: CER-1236 Phagocytic and Cytotoxic Transcriptional Signatures
Comprehensive RNA Analysis Showed CER - 1236 Possesses Phagocytic and Cytotoxic Transcriptional Signatures RNA - seq IPA analysis Combines cytotoxic and phagocytic function into single T cells 23 Molecular Therapy, 2023 May 16. PMID: 37194236. Differentially expressed genes among CER 1236 stimulated
Slide 24: CER-1236 Potent Cytotoxic Responses Against AML
0 2 4 6 8 10 0 12 22 32 42 52 62 74 86 96 106 116 Time (hrs) No T cells Untransduced CER - 1236 2:1 E:T 0 0 1 2 3 4 No T c U CER - 1236 Induces Potent Cytotoxic Responses Against High Risk Acute Myeloid Leukemia Subtypes 24 Mutated FLT - 3 - ITD AML Mutated TP53 AML Kasumi - 1 AML Cells MV4 - 11 AML
Slide 25: CER-1236 Cytotoxic Responses to B Cell Lymphomas and Solid Tumors
CER - 1236 Induced Potent Cytotoxic Responses In Vitro to Both B Cell Lymphomas and Solid Tumors Mantle Cell Lymphoma (MCL) EGFR - mutant NSCLC NSCLC Cells JeKo - 1 TMEM30a 0 10 20 30 40 50 60 80 90 100 110 120 130 140 0 5 10 15 20 25 70 Time (hrs) No T cells Untransduced CER - 1236 No T cells Untra
Slide 26: CER-T Cells Eliminated Lymphoma Xenografts In Vivo
CER - T Cells Eliminated Lymphoma Xenografts In Vivo A Single Infusion of CER - 1236 T Cells Single infusion of 2.5e^6 CER - 1236 T cells Eliminated TP53 mutant MCL tumors Observed improvements in survival without evidence for toxicity 0 40 10 4 10 5 10 6 10 7 10 8 10 9 10 10 20 Day post T cell infu
Slide 27: No Safety Signals in Small Animal Tumor Models
CER - 1236 T Cells Have Not Elicited Safety Signals in Small Animal Tumor Models 27 Single infusion of 7.5e^6 CER - 1236 T cells NO anemia, thrombocytopenia, neutropenia, or coagulation abnormalities NO weight loss, morbidity, unexpected mortality NO histological abnormalities across organs A Single
Slide 28: CER-1236 T Cells Rapidly Proliferated, No Premature Exhaustion
CER - 1236 T Cells Rapidly Proliferated and Showed No Premature Exhaustion 28 A Single Infusion of CER - 1236 T Cells Rapid Cell Expansion Repeat Antigen Stimulation Shows No Exhaustion Single infusion of 7.5e^6 CER - 1236 T cells Copy/ul Blood Day 20000 15000 10000 5000 Repeat antigen stimulation s
Slide 29: Building on Success, Poised for Translation
Building on Success, Poised for Translation • CER receptor humanization, molecular optimization, ICD testing, receptor stability screening, promoter selection, vector backbone harmonization, lead selection • Mechanism of action studies • Solid and Hematological animal modeling, pharmacokinetics, pha
Slide 30: Unique and Singular Strategic Positioning
Unique and Singular Strategic Positioning Killing Capability Starting Cell Source T cells / Lymphocytes Macrophages / Monocytes Phagocytosis Lysis PHAGOCYTOSIS + LYSIS 30 PHAGOCYTOSIS
Slide 31: Patent Portfolio Overview
• 11 US pending patent applications and 1 issued US application, 1 allowed • 29 pending foreign applications and 7 granted foreign applications in first family • Will continue to monitor and prosecute strategically • Key application already allowed with protection out to 2038 • Cancer agnostic • Fav
Slide 32: Plug and Play Manufacturing
Plug and Play Manufacturing GMP - ready process Experienced CDMO partner in place Currently transferring process Optimal product characteristics Completed Pre - IND review (preclinical and CMC) with FDA Process is analogous to CAR - T Cell 32
Slide 33: Clinical Grade GMP-Ready Manufacturing Process
29.6% 10.4% 28.4% 52.9% 23.6% 33.3% 18.3% 3.5% 0% 25% 50% 75% 100% D0 D7 Teff /CD3+ Tem /CD3+ Tcm /CD3+ Tnaive /CD3+ 33 Run ID Viability CER+ % IFNγ (pg/mL) CERo - 002 84.6 79.3 9821.6 CERo - 005 90.9 86.5 18554.9 CERo - 006 91.1 80 11056.3 CERo - 007 90.5 79.1 4992.4 CERo - 008 89.9 81 12948.1 CERo
Slide 34: Positioned for Phase I Success
Positioned for Phase I Success Deep preclinical data set, novel mechanism of action, clinical history with CAR - T Adaptive Phase I design: explore patient response in step - wise protocol, maximize opportunity to elicit clinical signal while evaluating safety Determine dose, conditioning therapy re
Slide 35: Clinical Strategy
Clinical Strategy Follow the Data – Preclinical Observations and Insights • Different MOA – Phagocytosis and Lysis • Extensive prevalence of naturally elevated Phosphatidylserine (PS) across diverse cancer types • CER - 1236 preclinical activity in multiple liquid and solid tumor types, including un
Slide 36: IND Approach
• Expected initial IND submission - safety first and efficient patient recruitment (e.g., completion within 12 months of IND) • Initially, AML patients, high - risk MDS, and “all - comer” Salvage B cell Lymphoma • With initial dose established, focus down on r/r AML, high - risk MDS • AML Monotherap
Slide 37: Phase I trial design: CER-1236 lymphodepletion and infusion
CER - 1236 Lymphodepletion with Fludarabine/Cyclophosphamide Lymphodepletion • Cyclophosphamide • Fludarabine CER - 1236 Manufacturing Screening Enrollment/Leukapheresis CER 1236 Infusion Efficacy Assessment • Based on standard criteria DLT Observation Safety Evaluation Day 28 Months 2 - 12 Disease
Slide 38: Quarterly Budget ($Thousands)
2 Year Budget 38 ($Thousands) 2023 2024 2025 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Starting Balance 40,000 32,699 28,914 22,962 18,447 13,500 8,500 3,077 Cash for Operations (1,503) (3,913) (6,041) (4,774) (5,132) (5,135) (5,507) (2,852) Deal Payments (6,198) − − − − − − − CAPEX − (200) (200) − − − − − Interest I
Slide 39: Investment Highlights
Investment Highlights CERo ‘reverse merge’ into Phoenix Biotech Acquisition Corp. (“PBAX”) 39 • Raising $40M to file IND, conduct human clinical data in several tumor types • $15M from insiders and PBAX • Remainder from new investors • Sponsor willing to share up to two - thirds of “promote” shares
Slide 40: Transaction Summary
Transaction Summary 40 SOURCES ($ in Millions) CERo Rollover $50.0 Cash in Trust 7.5 Proceeds from PIPE 32.5 Total $90.0 USES ($ in Millions) Equity to CERo $50.0 Cash to Balance Sheet 32.5 Est. Transaction Expenses 7.5 Total $90.0 Pro Forma Shares Outstanding (M) (1) Share Price ($) 14.5 $10.0 Deal
Slide 41: The Next Era in Cell Therapy
The Next Era in Cell Therapy Designed to Be a More Powerful Cancer Cell Killer UNIQUE APPROACH Powerful, multi - modal tumor clearing NEAR TERM VALUE IND anticipated in 12 months, human data in 24 months PROVEN SUCCESS Experienced team, top investors, and capital efficient LARGE OPPORTUNITY Targetin
Slide 42: Summary Risk Factors
Summary Risk Factors 42 All references to “we,” “us,” “our” and the “Company” refer to the business and operations of CERo Therapeutics, Inc . (“CERo”) prior to the consummation of the proposed Business Combination (as defined below) or to the business and operations of New CERo (as defined below) f
Slide 43: Risk factors: growth and financing
43 We have grown rapidly and will need to continue to grow the size of our organization, and we may experience difficulties in managing this growth. We may form or seek additional strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits o
Slide 44: Risk factors: orphan drug, privacy and healthcare reform
44 We may not be able to obtain orphan drug exclusivity for one or more of our product candidates, and even if we do, that exclusivity may not prevent the FDA from approving other competing products. We are subject to stringent and changing privacy laws, regulations and standards as well as policies
Slide 45: Risks Related to New CERo's Common Stock
Risks Related to New CERo’s Common Stock 45 An active trading market for New Cero’s common stock, may not be available on a consistent basis to provide stockholders with adequate liquidity. The price of the New Cero common stock may be extremely volatile, and stockholders could lose all or part of t
Slide 46: Risks Related to the Business Combination
46 There is no guarantee that a stockholder’s decision to continue to hold Class A Common Stock will put the stockholder in a better future economic position than if they decided to redeem their Class A Common Stock for a pro rata portion of the Trust Account will put the stockholder in a better fut
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