CERo Therapeutics Holdings, Inc. · OTC:CERO
CERo Therapeutics — Phoenix Biotech Acquisition — SPAC Merger (October 2022)
32 slides from CERo Therapeutics's SPAC merger presentation, Oct 31, 2022
Slide 1: Corporate Presentation: Developing New Drugs for Gut-Brain Axis Disorders
CORPORATE PRESENTATION Developing New Drugs for Gut-Brain Axis Disorders October 2022
Slide 2: Disclaimer
Disclaimer General This presentation is provided for informational purposes only and has been prepared to assist interested parties in making their own evaluation with respect to the proposed business combination by and between Phoenix Biotech Acquisition Corp. (“PBAX”), Intrinsic Medicine, Inc. (“I
Slide 3: Disclaimer (Continued)
Disclaimer (Continued) NEITHER THE SEC NOR ANY OTHER SECURITIES COMMISSION OR SIMILAR REGULATORY AUTHORITY, IN THE UNITED STATES, CANADA OR ELSEWHERE, HAS REVIEWED, APPROVED OR DISAPPROVED OF ANY SECURITIES OR THIS PRESENTATION OR DETERMINED IF THIS PRESENTATION IS TRUTHFUL OR COMPLETE, AND ANY REPR
Slide 4: Disclaimer (Continued): Industry and Market Data
Disclaimer (Continued) Industry and Market Data Certain information contained herein or disclosed orally during this presentation relate to or are based on studies, publications, surveys and other data obtained from third-party sources and PBAX’s and Intrinsic Medicine’s own internal estimates and r
Slide 5: Transaction Overview
Transaction Overview Illustrative Post-Money Valuation at Close PF Transaction ($ M) Intrinsic Illustrative Share Price $10.00 PF Shares Outstanding 36.59 Total Equity Value $365.9 Less: Cash (166.3) Plus: Rollover Convertible Notes 7.7 Total Enterprise Value $207.3 Illustrative Estimated Transactio
Slide 6: PBAX is a $175M biotech SPAC, founded on life sciences and transaction expertise
PBAX is a $175M biotech SPAC, founded on life sciences and transaction expertise The team is led by seasoned biotech industry professionals Brian Atwood, Chairman Chris Ehrlich, Chief Executive Officer Doug Fisher, MD, President Dan Geffken, Chief Financial Officer ? Former Chairman of Locust Walk?
Slide 7: Gut-Brain Axis Disorders Have Broad Impact, Yet Few Treatment Options
Parkinson’s Anxiety—Autism Depression WHY? Gut-Brain Axis (GBA) Disorders Have Broad Impact, Yet Few Treatment Options • GBA disorders are a major burden on the Chronic healthcare system Pain Idiopathic Constipation • We believe most people will be affected within their lifetime • Dysregulation of m
Slide 8: Approved GBA Treatments Have Significant Limitations
All Patients THE PROBLEM Approved GBA Treatments Have Significant Limitations Side Effect Burden • Polarizing mechanisms Safe & Tolerable REPRESENTATIVE WARNINGS lead to safety and AND PRECAUTIONS: tolerability issues PATIENTS MAY EXPERIENCE SEVERE DIARRHEA1 CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA
Slide 9: Intrinsic Medicine's Lead Program
All Patients Intrinsic Medicine’s Lead Program Alone THE SOLUTION No toxicities to date4 Competitors’ Problems are Microbiome effects5 Modulates inflammation6 Intrinsic’s Platform Side Effect Burden Opportunity Safe & Tolerable REPRESENTATIVE WARNINGS AND PRECAUTIONS: • Potential for safety, tolerab
Slide 10: Potential for HMOs to be the Optimal Therapeutic Approach
APPROACH Potential for Human Milk Oligosaccharides (HMOs) to be the Optimal Therapeutic isorders Microbiome Effects1 J Direct Effects3 • Increase beneficial LNnT • Modulate immune cells microbes H D-FL C • Modulate phenotype G D E B • Reduce pathogenic A of somatic cells microbes I 6’SL • Modulate n
Slide 11: Lead Candidate OM002: Synthetic Biology Produced 2'-Fucosyllactose
LEAD CANDIDATE OM002: Synthetic Biology Produced 2’-Fucosyllactose Oligosaccharide OM002 (2’FL) • Small molecule (MW – 488.44) • Orally bioavailable • Readily dissolvable in water • Resistant to gastric degradation • 2-year shelf stability established at ambient conditions 11
Slide 12: Key Investment Highlights
KEY INVESTMENT HIGHLIGHTS Creating Value with Several Significant, Near-term Clinical Milestones Experienced management team and medical & scientific advisory boards Lead program, OM002, is Phase 2b-ready for IBS-C, informed by open-label efficacy, safety, and tolerability data supporting potential
Slide 13: Intrinsic Medicine Pipeline
INTRINSIC MEDICINE PIPELINE Three Lead Programs, Produced with Scalable Synthetic Biology Protocol Candidate Preclinical Pre-IND Phase 1 Phase 2 Next Anticipated Milestone Approved Initiate Phase 2b clinical trial under a HREC Phase 2 approved protocol in Australia in 1H:23; IBS – C Approved IND sub
Slide 14: Unmet Need: Patients and Physicians Speaking Out About IBS Treatments
UNMET NEED Patients and Physicians are Speaking Out About the Need for Better IBS Treatments #ibs #guthealth #irritablebowelsyndrome #ibstok #guttok #guthealing #stomachproblems 1.4B views 1.8B views 62.3M views 190.2M views 533.2M views 133.9M views #493.6M views 14 INTRINSIC MEDICINE
Slide 15: Open-Label Clinical Data: Improvements in All IBS Subtypes
OPEN-LABEL CLINICAL DATA OF 2’FL DOMINANT HMO MIXTURE Clinically-Significant Improvements in All IBS Subtypes -Positions OM002 to Potentially Address Unmet Need Changes in Overall IBS Symptom Severity Score Change in Total % of Abnormal Consistency Stools (IBS-SSS, 0-500 scale) Severe IBS Moderate I
Slide 16: Effects on Abdominal Pain and Bloating
OPEN-LABEL CLINICAL DATA OF 2’FL DOMINANT HMO MIXTURE Effects on Abdominal Pain and Bloating in Excess of Placebo Response in Approved Drug Phase 2b Controlled Studies Changes in Abdominal Pain and Bloating Severity1 Linzess (linaclotide) 12 weeks from Baseline2 Across All IBS Subtypes N(300mcg)=84
Slide 17: Studies Suggest Potential for Tolerability Advantage
OPEN-LABEL CLINICAL DATA OF 2’FL DOMINANT HMO MIXTURE Studies Suggest Potential for Tolerability Advantage Over Linzess (linaclotide), 80% Fewer Side Effects Observed 2 Across All IBS Subtypes (n=317), IBS-C (n=136)1 Numbers Patient 2’FL Dominant Linzess (300ug) HMO Mix for IBS-C Total Disclosed AEs
Slide 18: OM002 IBS-C Clinical Program Guided by World-Class KOLs
OM002 IBS-C CLINICAL PROGRAM Guided by World-Class IBS Key Opinion Leaders Brian E. Lacy, MD, PhD Nicholas J. Talley, MD, PhD Mayo Clinic, Jacksonville, FL University of Newcastle, Australia, Mayo Clinic and UNC Chapel Hill • Author of the American College of Gastroenterology Treatment Guidelines fo
Slide 19: OM002 Phase 2b Indication: IBS-C
>5M Adults, Children, and Adolescents in US1 OM002 PHASE 2B INDICATION: IBS-C A Prevalent, Debilitating, Significant Daily Burden: and Underserved Gas and bloating GBA Disorder Abdominal pain Nausea Straining, infrequent stool and inability to completely empty 1. Palsson, O. S., et al. Prevalence of
Slide 20: IM-OM002-101 Planned Phase 2b Study in IBS-C
IM-OM002-101 Our Planned Phase 2b Study in IBS-C A Phase 2, Double-Blind, Placebo-Controlled, Multiple Dose, Dose-Ranging Study to Assess the Safety and Efficacy of OM002 Administered Orally to Subjects with Irritable Bowel Syndrome with Constipation Study Components Primary Objective • 417 Subjects
Slide 21: OM002 Development Well Underway
OM002 Development Well Underway All Domains Advancing to Support Clinical Program Clinical Development Phase 2b protocol developed with KOLs Regulatory OM002 Phase 2b study approved by HREC in AU Pre-IND completed in the second quarter of 2021 with FDA guidance for IND in the US Clinical and Commerc
Slide 22: IBS-C Competitive Landscape
IBS-C COMPETITIVE LANDSCAPE OM002 Positioned to Redefine Treatment FDA Approved Therapeutics Investigational Therapeutics* ® ® ® ® ® ® 6 ® Zelnorm Amitiza Linzess Trulance Ibsrela Olorinab OM002 1 2 3 5 Blautix 7 8 SVT-1B149 SMP-100 (tegaserod) (lubiprostone) (linaclotide) (plecanatide)4 (tenapanor)
Slide 23: Current IBS Market
CURRENT IBS MARKET Validated Billion Dollar Market Opportunities Despite Safety, Tolerability and Efficacy Limitations of Approved Drugs IBS-C: IBS-D: IBS-M: ~5M US sufferers1 ~5M US sufferers ~5M US sufferers >$1B annual sales2 >$1.6B annual sales3 No approved drugs 18+ use 18+ use Black box safety
Slide 24: Intrinsic Medicine Pipeline
INTRINSIC MEDICINE PIPELINE Three Lead Programs, Produced with Scalable Synthetic Biology Protocol Candidate Preclinical Pre-IND Phase 1 Phase 2 Next Anticipated Milestone Approved Initiate Phase 2b clinical trial under a HREC Phase 2 approved protocol in Australia in 1H:23; IBS – C Approved IND sub
Slide 25: OM001 (3'SL) Ready to Move Into Clinic
OM001 (3’SL) Ready to Move Into Clinic with Preclinical Data Supporting Multi-Indication Potential Brain, Behavior, And Immunity The prebiotics 3?Sialyllactose and 3?-Sialyllactose as an inhibitor of 3?-Sialyllactose prebiotics prevents 6?Sialyllactose diminish stressor-induced p65 phosphorylation a
Slide 26: GBA Investment Trends
GBA INVESTMENT TRENDS Visionary Biotech Investors Are Taking Long Positions in GBA Drug Companies $236M raised in 2022 6 of 9 programs in discovery $106.1M market cap $349.6M market cap 1 IND-enabling program and 3 in Phase 1 3 of 3 chronic programs in preclinical Most advanced of 3 chronic programs
Slide 27: Experienced Team to Execute Business and Clinical Objectives
We Have Assembled an Experienced Team to Execute Business and Clinical Objectives Intrinsic Medicine Leadership Independent Board of Directors TBA Alex Martinez, JD Jason Ferrone, JD Emil Chuang, MD Dustin Crawford To Be Announced Patrick Gray Joan Stafslien, JD Chairman & CEO President & COO CMO Ge
Slide 28: Investment Summary
INVESTMENT SUMMARY Establishing GBA Leadership with a Phase 2b IBS-C Clinical Catalyst Expected H1:24 Experienced management team and medical & scientific advisory boards Lead program, OM002, is Phase 2b-ready for IBS-C, informed by open-label efficacy, safety, and tolerability data supporting poten
Slide 29: Risk Factors
Risk Factors The risks presented below are certain of the general risks related to Intrinsic Medicine, Inc. (the “Company” or “Intrinsic Medicine”), Phoenix Biotech Acquisition Corp. (“PBAX”) and the proposed business combination between Intrinsic Medicine, PBAX anda OM Merger Sub, Inc., a wholly-ow
Slide 30: Risk Factors (Continued)
Risk Factors (Continued) • Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition, or results of operations. • Our HMO drug candidates rely on the availability of specialty raw materials,
Slide 31: Risk Factors (Continued)
Risk Factors (Continued) • Even if we obtain approval from the FDA, the European Medicines Agency (“EMA”) or the Australian Therapeutic Goods Association (“TGA”) for any of our drug candidates in the United States, European Union or Australia, we may never obtain approval for or commercialize any of
Slide 32: Risk Factors (Continued)
Risk Factors (Continued) • We have broad discretion in the use of our existing cash and the net proceeds from the completion of the Business Combination and may not use them effectively. • If we engage in future acquisitions or strategic partnerships, this may increase our capital requirements, dilu
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