Maia Biotechnology, Inc. · AMEX:MAIA
Maia Biotechnology — IPO Roadshow (July 2022)
31 slides from Maia Biotechnology's IPO roadshow presentation, Jul 14, 2022
Slide 1: Telomere Targeting Immunotherapies for Cancer
TELOMERE TARGETING IMMUNOTHERAPIES FOR CANCER July 2022 MAIA BIOTECHNOLOGY MAIA BIOTECHNOLOGY Logo TELOMERE TARGETING IMMUNOTHERAPIES FOR CANCER July 2022
Slide 2: Free Writing Prospectus
Free Writing ProspectusThis free writing prospectus relates to the proposed initial public offering of common stock, par value $0.0001 per share of MAIA Biotechnology, Inc. (the "Company"), which are being registered on a registration statement and should be read together with the preliminary prospe
Slide 3: Disclosure
DISCLOSURE All statements in this presentation, other than those relating to historical facts, are "forward-looking statements." These forward-looking statements may include, but are not limited to, statements relating to our objectives, plans, and strategies; statements that contain projections of
Slide 4: Offering Summary
OFFERING SUMMARY Issuer MAIA Biotechnology, Inc. Proposed Symbo NYSE American: MAIA Expected Offering Size $10,000,000 Expected Price Range $5 - $7 / share Shares Offered 1,666,667 Over-Allotment 15% (250,000 shares) Use of Proceeds – Advance two clinical trials: THIO-101 in NSCLC and THIO-102 in CR
Slide 5: Company Overview
COMPANY OVERVIEW PIPELINE THIO-101: Phase 2 Trial of THIO + LIBTAYO® (cemiplimab) in Non-Small Cell Lung Cancer (NSCLC) enrolling – Ex-US strategy initially: Australia and Europe – Evolve into pivotal trial; to include US sites – Planned second-line therapy – Regeneron clinical supply agreement for
Slide 6: THIO: Dual Mechanism of Action In Vivo
THIO: DUAL MECHANISM OF ACTION IN VIVO Direct Telomere-Targeting: Lead to Cancer Cell Death1 Immunogenic Effect: Anti-Tumor Immune Activation (in vivo2 ) 1 THIO metabolized and utilized telomerase in cancer cells 2 THIO metabolite was observed to incorporate into telomeres by telomerase 3 Telomeric
Slide 7: Pipeline
PIPELINE logo Robust pipeline includes several targeted immuno-oncology therapies for difficult-to-treat cancers LEAD ID PRECLINICAL PHASE 1 PHASE 2 PHASE 3 COLLABORATION & RIGHTS THIO Telomere targeting agent THIO-101 Non-Small Cell Lung Cancer (NSCLC) THIO Libtayo Phase 2 Enrolling July 2022 World
Slide 8: Regeneron Clinical Supply Agreement - Libtayo
REGENERON CLINICAL SUPPLY AGREEMENT - LIBTAYO Goal of Study: New Standard of Care for Treatment of NSCLC Phase 2 dose optimization study, to evolve into a pivotal study for US approval: Safety lead-in Select optimal dose for planned pivotal study Contribute Drug Supply LIBTAYO®️ (cemiplimab; anti-PD
Slide 9: THIO-101 Study: Phase 2 in Advanced NSCLC
THIO-101 STUDY: PHASE 2 IN ADVANCED NSCLC A Multicenter, Open-Label, Dose-Finding Phase 2 Study Evaluating the Safety and Efficacy of THIO Administered in Sequence with LIBTAYO® (cemiplimab) Primary Endpoints Overall Response Rate (ORR) Secondary Endpoints ORR in telomerase positive patients; Comple
Slide 10: THIO-101 Study in NSCLC: Anticipated Clinical Outcomes
THIO-101 STUDY IN NSCLC: ANTICIPATED CLINICAL OUTCOMES EXTRAPOLATED FROM PRECLINICAL DATA Catalyst Timing Current SOC (chemo) THIO → LIBTAYO (expected) Safety Q3-Q4 2022 72-79% Grd ≥3 10-20% Grd ≥3 Preliminary Efficacy (ORR in first 30-40 pts) Q4 2022 – Q1 2023 11-23% 30-60% PFS H2 2023 4-4.5 months
Slide 11: Biomarker of On-Target Biological Activity: TIFs
BIOMARKER OF ON-TARGET BIOLOGICAL ACTIVITY: TIFS THIO induced telomere dysfunction in Lewis Lung Carcinoma (LLC) cells: in vitro NSCLC model Confocal microscopy image of LLC cell nucleus after treatment with 3 µM of THIO Quantification of TIFs induced in LLC cell by 3 µM of THIO(graphics) Yellow dot
Slide 12: THIO-102 Study: Planned Phase 2 Study in Three Cancer Indications
THIO-102 Study: PLANNED Phase 2 study IN THREE CANCER INDICATIONS (MASTER PROTOCOL INCORPORATING DESIGN FEATURES COMMON TO BOTH “basket” and “UMBRELLA” Trials) A Multicenter, Open-Label, Phase 2 Study Evaluating the Safety and Efficacy of THIO Administered in Sequence with Anti-PD-1 or Anti-PD-L1 in
Slide 13: THIO-102 Trial: Catalysts and Rationale for the CRC Arms
THIO-102 TRIAL: CATALYSTS AND RATIONALE FOR THE CRC ARMS Catalyst Timing Current SOC (chemo) THIO → CPI (expected) Safety Early H1 2023 50-60% Grd ≥3 10-20% Grd ≥3 ORR Late H1 2023 1-1.6% 10-20% PFS H2 2023 1.9-2.0 months 3-6 months OS H1 2025 6.4-7.2 months 9-12 months THIO followed by PD-L1 blocka
Slide 14: Multiple Value-Driving Milestones
MULTIPLE VALUE-DRIVING MILESTONES Potential Accelerated Approval in US Filing for US approval 2H OS from THIO-101 1H Ph 2/3 THIO-103 Basket Study First Line in Multiple Solid Tumors 2H PFS from THIO-101 2H Ph 2 THIO-102 Basket/Umbrella Study CRC, HCC, SCLC Q4-Q1 2023 Prelim Efficacy Data THIO-101 2H
Slide 15: Significant Market Opportunity
SIGNIFICANT MARKET OPPORTUNITY #1 Worldwide: NSCLC/ #2 Worldwide: CRC Mortality: 1.6M in 2021 Sales: $23B in 2021 Mortality 943,000 in 2021 Sales $8B in 2021 Checkpoint Inhibitors Five approved for NSCLC (Keytruda, Opdivo, Tecentriq, Imfinzi, Libtayo) – $12B of $23B total NSCLC drug sales in 2021 –
Slide 16: Exclusivity and Intellectual Property Summary
EXCLUSIVITY AND INTELLECTUAL PROPERTY SUMMARY Goal: NCE Marketing Exclusivity • THIO (6-thio-2’-deoxyguanosine) has never been previously approved by the FDA • NCE exclusivity if granted blocks submission of competing ANDAs and 505(b)(2) NDAs for 5 years Robust and Growing Patent Portfolio for THIO
Slide 17: Comparable Companies
COMPARABLE COMPANIES(logo) $3.48 Billion $1.52 Billion $1.84 Billion $1.26 Billion $4.1 Billion* COMPARABLE COMPANIES Market Caps as of July 11, 2022 (source: S&P CapitalIQ) 17 * On June 3, 2022, Bristol Myers Squibb announced the acquisition of Turning Point Therapeutics in an all-cash transaction
Slide 18: Capitalization Table
Capitalization Table Pro Forma Pre-IPO Cap Table (as of 7/13/2022) Common Stock(1) 8,553,452 Options (WAEP: $2.43)(2) 5,927,523 Warrants (WAEP: $5.97) 702,505 Fully Diluted Shares Outstanding 15,183,480 1) Includes 137,420 restricted shares to be issued to prior round investors, assuming the mid-poi
Slide 19: Highly Experienced Management Team
HIGHLY EXPERIENCED MANAGEMENT TEAM Vlad Vitoc, MD, MBA Founder, Chairman, and Chief Executive Officer(image) Sergei Gryaznov, PhD Chief Scientific Officer(Image) Mihail Obrocea, MD Chief Medical Officer(Image) 22+ yrs. Pharma/Biotech: Commercial, Medical, 12 compounds launched, 20+ tumor types, 8 On
Slide 20: Investment Highlights
INVESTMENT HIGHLIGHTS Two Ex-US Clinical Programs – Ph 2 NSCLC THIO-101 + Libtayo® (cemiplimab) Regeneron; Enrolling – Ph 2 CRC, HCC, and SCLC THIO-102; Planned Q1 2023 1 THIO is a Unique Direct Telomere Targeting Agent – Potential to be used in combination with other anticancer immune therapies – D
Slide 21: MAIA Biotechnology: Telomere Targeting Immunotherapies for Cancer
MAIA BIOTECHNOLOGY TELOMERE TARGETING IMMUNOTHERAPIES FOR CANCER July 2022
Slide 22: Scientific Advisors
SCIENTIFIC ADVISORS David M Ashley, PhD MBBS (Hon), FRACP, PhD, is Director, The Preston Robert Tisch Brain Tumor Center, Head, Preuss Laboratory, and Director, Pediatrics Neuro-Oncology, Duke University Professor David Ashley’s career in cancer research dates more than two decades. He is credential
Slide 23: Telomeres: Key Therapeutic Targets for Cancer
TELOMERES: KEY THERAPEUTIC TARGETS FOR CANCER [Graphic] * Source: Adapted from Cell , Volume 144, Issue 5, Pages 646-674 (DOI:10.1016/j.cell.2011.02.013)
Slide 24: THIO Preparing for Clinical Trials in Pediatric Brain Tumors
THIO PREPARING FOR CLINICAL TRIALS IN PEDIATRIC BRAIN TUMORS THIO demonstrated penetration of BBB and inhibited tumor growth in in vivo models, inducing in-tumor Telomere dysfunction and cancer cell death in difficult to treat cancer where no therapy exists Evidence of THIO’s Primary Mechanism In-tu
Slide 25: Preclinical Results Show That THIO Treatment Led to TIFs
PRECLINICAL RESULTS SHOW THAT THIO TREATMENT LED TO TIFS THIO led to telomere dysfunction-induced foci (TIFs) in telomerase-positive cancer cells, but not in normal, telomerase-negative cells (in vitro) Normal Fibroblasts Fibroblasts with Introduced hTERT TRF2 Gamma- H2AX TIF Telomeric DNA is ~1/600
Slide 26: MOA Biomarkers of THIO's Immunological Activity In Vitro
MOA BIOMARKERS OF THIO’S IMMUNOLOGICAL ACTIVITY IN VITRO Micronuclei generated in response to THIO-induced telomeric DNA modification, replication stress, recruit and activate of cGAS, which leads to cellular senescence in cancer cells cGAS is recruited to micronuclei induced by 6-thio-dG: co-locali
Slide 27: New Results About Immunogenic Effects of THIO Published in Cancer Cell
NEW RESULTS ABOUT IMMUNOGENIC EFFECTS OF THIO PUBLISHED IN CANCER CELL A key peer-reviewed publication released online in the renowned journal Cancer Cell on July 2, 2020. “Telomere Stress Potentiates STING-Dependent Anti-tumor Immunity,” was authored by researchers at the University of Texas Southw
Slide 28: THIO Induction of Systemic Anti-Tumor Immunity in CRC In Vivo
THIO INDUCTION OF SYSTEMIC ANTI-TUMOR IMMUNITY IN COLORECTAL CANCER (CRC) IN VIVO THIO followed by PD-L1 blockade resistance in MC38 cells in murine model turns immunologically cold tumors to hot and was curative Regimen 0.5 M MC38 Cells Injected THIO 3mg/kg PD-L1 50μg 0 10 11 13 17 day100 200 300 4
Slide 29: THIO Induction of Systemic Anti-Tumor Immunity in CRC In Vivo
THIO INDUCTION OF SYSTEMIC ANTI-TUMOR IMMUNITY IN COLORECTAL CANCER (CRC) IN VIVO THIO followed by PD-L1 blockade in MC38 cells in murine model was curative, accompanied by generation of immune memory Regimen 0.5 M MC38 Cells Injected 0.5 M MC38 Cells Injected THIO 3mg/kg PD-L1 50μg 0 10 11 13 17 da
Slide 30: THIO Induction of Systemic Anti-Tumor Immunity in CRC In Vivo
THIO INDUCTION OF SYSTEMIC ANTI-TUMOR IMMUNITY IN COLORECTAL CANCER (CRC) IN VIVO THIO followed by PD-L1 blockade in MC38 cells in murine model was curative, accompanied by generation of immune memory Regimen 0.5 M MC38 Cells Injected 0.5 M MC38 Cells Injected THIO 3mg/kg PD-L1 50μg 0 10 11 13 17 da
Slide 31: THIO Sequential with PD-L1 Antibody in Lung Cancer In Vivo
THIO SEQUENTIAL WITH PD-L1 ANTIBODY IN LUNG CANCER IN VIVO Anti-tumor in Lewis Lung Carcinoma (LLC) model: 80% complete response, 20% partial response Development of immunological tumor-specific directed memory 1M LLC Cells Injected THIO 3mg/kg 0 456 8 10 11 13 day PD-L1 200μg Rechallenge with 5X mo