Maia Biotechnology, Inc. · AMEX:MAIA
Maia Biotechnology — IPO Roadshow (April 2023)
34 slides from Maia Biotechnology's IPO roadshow presentation, Apr 20, 2023
Slide 1: MAIA Biotechnology: Telomere Targeting Immunotherapies for Cancer
MAIA BIOTECHNOLOGY TELOMERE TARGETING IMMUNOTHERAPIES FOR CANCER NYSE AMERICAN: MAIA April 2023
Slide 2: Free Writing Prospectus
FREE WRITING PROSPECTUS This presentation highlights basic information about us and the proposed offering. Because it is a summary, it does not contain all of the information that you should consider before investing. We have filed a registration statement (including a prospectus) with the SEC for t
Slide 3: Forward Looking Statements
FORWARD LOOKING STATEMENTS 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
Slide 4: Investment Overview
INVESTMENT OVERVIEW • Telomere-Targeting Agents: o THIO in clinic o Advancing pipeline • Efficacy • Safety • FDA: 2 Orphan Drug Designations • REGN: Clinical Supply Agreement • Phase 2 THIO-101 trial in NSCLC underway o Enrolling in AUS and EU o On track to open sites in US in 2023 o Upcoming Milest
Slide 5: Robust Pipeline
ROBUST PIPELINE PRECLINICAL PHASE 1 PHASE 2 PHASE 3 COLLABORATION & RIGHTS THIO Telomere targeting agent THIO-101 NSCLC THIO → Libtayo THIO-102 CRC, HCC, ST THIO → CPI THIO-103 NSCLC, SCLC First Line Ph 2 Enrolling July 2022 Ph 2 Planning Ph 2/3 Planning Worldwide rights owned by MAIA Worldwide righ
Slide 6: Science Overview
SCIENCE OVERVIEW THIO (6-thio-dG) Telomere Targeting Agent • Small molecule (penetrates blood-brain barrier) • Eligible for NCE marketing exclusivity • Dual MoA: telomere targeting + immunogenic • Complete Response with No Recurrence in vivo in Lung, Colorectal, Liver, Melanoma, Brain Cancer (GBM, D
Slide 7: Mission and Approach
MISSION AND APPROACH 7
Slide 8: Cancer is the most dominant age-related disease
Cancer is the most dominant age-related disease Population aged >80 expected to triple by 2050 142 million 2020 426 million 2050 At age 90: 40% will be diagnosed 20% will die of it 8
Slide 9: THIO is the only direct telomere targeting agent in clinical development
THIO is the only direct telomere targeting agent currently in clinical development 9
Slide 10: THIO - Mechanisms of Action
THIO - MECHANISMS OF ACTION THIO CPIs THIO has a dual MoA: 1 Telomere targeting 2 Immunogenic effect 3 Checkpoint Inhibitors (cemiplimab) (pembrolizumab) (atezolizumab) (nivolumab) (durvalumab) Partnership with REGN for NSCLC 10
Slide 11: MAIA Biotechnology & Regeneron
MAIA BIOTECHNOLOGY & REGENERON MAIA Biotechnology, Inc. Announces Clinical Supply Agreement with Regeneron for Phase 1/2 Clinical Trial Evaluating THIO in Sequential Administration with Libtayo(R) (cemplimab) in Advanced Non-Small Cell Lung Cancer 11
Slide 12: THIO-101 Trial (Ongoing)
THIO-101 TRIAL (ONGOING) A Multicenter, Open-Label, Dose-Finding Phase 2 Trial Evaluating the Safety and Efficacy of THIO Administered in Sequence with LIBTAYO® (cemiplimab) Part A: Safety Part B: Efficacy / Safety / Dose Selection Part C*: Registration Every 3 Weeks NSCLC 2L+ THIO 360mg cemiplimab
Slide 13: Favorable Safety Profile
FAVORABLE SAFETY PROFILE • Safety events reported during dose-limiting toxicity window • 360 mg/cycle – THIO highest dose • Data from 6 patients who completed the dose-limiting toxicity (DLT) period in Cycle 1 (3 weeks) • No Serious Adverse Events (SAE) or Serious Unexpected Suspected Adverse Reacti
Slide 14: Favorable Safety Profile: Adverse Events
FAVORABLE SAFETY PROFILE Adverse events (AE) reported – DLT window (3 weeks) Grade Fatigue 1 Decreased appetite 1 Blood pressure fluctuation 1 Dyspnea 1 Nausea 1 Interleukin-6 (IL-6) level increased* 1 Rash erythematous 1 Constipation 1 Myalgia 1 Vomiting 2 Nausea** 3 *T-cell activation **Resolved w
Slide 15: Preliminary Survival Data
PRELIMINARY SURVIVAL DATA • The first 2 patients enrolled in Part A of the study continue to be alive, approximately 10 and 9 months respectively, from treatment initiation • Both patients have advanced Stage IV metastatic disease and are heavily pretreated, receiving third and fourth line of therap
Slide 16: Preliminary Survival Data
PRELIMINARY SURVIVAL DATA 01-003 02-002 17-006 17-007 14-008 14-009 10-010 10-011 08-012 14-013 10-014 10-015 10 mos 9 mos = On treatment = In Follow Up = Day 1 of Cycle 0 6 12 18 24 30 36 42 48 Weeks Survival status based on cut-off of 20 April 2023 16
Slide 17: THIO followed by CPI results in 60% complete response
THIO followed by CPI results in 60% complete response • No recurrence after long-term follow-up • Anticancer immune memory has been induced: no cancer after rechallenge with 5x more lung cancer (LLC) cells with no additional therapy 1000 900 800 700 600 500 400 300 200 100 0 Control Atezolizumab THI
Slide 18: THIO-101 – Non-Small Cell Lung Cancer
THIO-101 – NON-SMALL CELL LUNG CANCER • Target: 20% improvement on Standard of Care (SOC) Catalyst Timing Current SoC (Chemo) Toxicity Q1 2023 72-79% Grd 3-4 ORR (Overall Response Rates) 2023 11-23% CR (Complete Response) 2023 0% DoR (Duration of Response), PFS (Progression Free Survival) 2024 4-4.5
Slide 19: Biomarker – TIFs
BIOMARKER – TIFS (TELOMERE DYSFUNCTION INDUCED FOCI) Confocal microscopy image of LLC cell nucleus after treatment with THIO Quantification of TIFs induced in LLC cell by 3 µM of THIO DAPI γH2AX Tel C • Yellow dots indicated TIFs by THIO • Green dots - γH2AX • Red dots - telomeres THIO • TIFs induct
Slide 20: THIO-102 Trial (Planned)
THIO-102 TRIAL (PLANNED) A Multicenter, Open-label, Phase 2 Trial Evaluating the Safety and Efficacy of THIO Administered in Sequence with Anti-PD-1 or Anti-PD-L1 Part A/B: Safety/Efficacy Signal Part C: Pivotal Phase 2 Baskets Umbrella Arms CRC HCC Solid Tumors2 THIO1 THIO1 THIO1 TECENTRIQ (atezoli
Slide 21: THIO-102 Trial – Colorectal Rationale
THIO-102 TRIAL – COLORECTAL RATIONALE • THIO followed by CPI results in 100% complete response • No recurrence after long-term follow-up • Anticancer immune memory has been induced: no cancer 700 600 500 400 300 200 100 0 0 10 20 100% CR Control Atezolizumab THIO THIO → Atezo after rechallenge with
Slide 22: THIO-102 Trial - Colorectal
THIO-102 TRIAL - COLORECTAL • Target: 20% improvement on Standard of Care (SOC) Catalyst Timing Current SoC (Chemo) Toxicity 2024 50-60% Grd ≥ 3 ORR 2024 1-1.6% DoR, PFS 2025 1.9-2.0m OS 2026 6.4-7.2m 22
Slide 23: SCLC & HCC – Orphan Drug Designation
SCLC & HCC – ORPHAN DRUG DESIGNATION 1500 1250 1000 750 500 250 0 SCLC 0 5 10 15 20 25 Days After Tumor Inoculation Control Pembro → THIO THIO → Pembro 1500 1250 1000 750 500 250 0 HCC 0 5 10 15 20 25 Days After Tumor Inoculation Control THIO THIO → IR IR + Atezo THIO → IR + Atezo • THIO is synergis
Slide 24: Excellent Efficacy in HCC Models
EXCELLENT EFFICACY IN HCC MODELS HCC • THIO achieved complete and durable responses in Hepatocellular Carcinoma (HCC), the dominant histology in primary liver cancer (90%), in in vivo models 100% CR 24
Slide 25: HCC Anti-Cancer Immune Memory
HCC ANTI-CANCER IMMUNE MEMORY • When combined with immunotherapy checkpoint inhibitor Libtayo®, duration of response was further potentiated HCC • Upon rechallenge with two times more cancer cells and no additional treatment, tumor growth was completely prevented Rechallenge with HCC • Administratio
Slide 26: THIO-103 Trial (Planned)
THIO-103 TRIAL (PLANNED) A Multicenter, Open-label, Phase 2 Trial Evaluating the Safety and Efficacy of THIO Administered in Sequence with Anti-PD-1 or Anti-PD-L1 Baskets Part A/B: Safety/Efficacy Signal Part C: Pivotal Phase 3 SCLC First Line NSCLC First Line THIO1 THIO1 EP + TECENTRIQ (atezolizuma
Slide 27: Exclusivity and Intellectual Property
EXCLUSIVITY AND INTELLECTUAL PROPERTY Goal: New Chemical Entity (NCE) Marketing Exclusivity • THIO has never been previously approved by the FDA for commercialization • Robust exclusivity • US: 7 years; EU, Japan, other markets: 10 years Robust and Growing Patent Portfolio for THIO • 1 issued US pat
Slide 28: Experienced Management Team
EXPERIENCED MANAGEMENT TEAM Vlad Vitoc, MD, MBA Founder, Chairman, and Chief Executive Officer • 22+ years in Oncology Pharma/ Biotech: Commercial, Medical • 12 compounds launched across 20+ tumor types • Leadership roles at Bayer (Nexavar), Astellas (Tarceva, Xtandi), Cephalon (Treanda), Novartis (
Slide 29: Capitalization Table
Capitalization Table (as of 12/31/2022) Common stock 10,955,904 Options (WAEP: $2.55)1 6,545,628 Warrants (WAEP: $6.04) 796,985 Fully Diluted Shares Outstanding 18,298,517 Cash Balance of $10.95 million (as of 12/31/2022) 1 4,282,309 options held by directors and officers Note: Directors and officer
Slide 30: Investment Opportunity
INVESTMENT OPPORTUNITY 30
Slide 31: Significant Market Opportunity
SIGNIFICANT MARKET OPPORTUNITY Developing agents for the top tumor types markets globally $42B… NSCLC #1 WW Mortality: 1.7M Sales: $ 34B CRC #2 WW Mortality: 1.0M Sales: $ 20B $42B CPIs Group • 5 CPIs approved for NSCLC sold $12B • >30% of NSCLC drug sales • >40% of total CPI sales • Keytruda®: $7.5
Slide 32: Comparable Companies
COMPARABLE COMPANIES $41M $2.4B $1.2B $1.3B $0.8B $4.1B • On June 3, 2022, Bristol Myers Squibb announced the acquisition of Turning Point Therapeutics in an all-cash transaction for $4.1B in equity value. 32 Market Caps as of April 18, 2023 (source: S&P CapitalIQ)
Slide 33: Multiple Value-Driving Milestones
MULTIPLE VALUE-DRIVING MILESTONES • Major inflection points Potential Accelerated Approval in US Filing for US approval THIO-101 Safety Data THIO-101 IND filing THIO-101 ORR THIO-101 DoR, PFS THIO-103 Ph 2/3 SCLC, NSCLC First Line THIO-102 Ph 2 CRC, HCC, ST THIO-101 OS 2023 2024 2025 33
Slide 34: July 28, 2022 P&S
NYSE: MAIA July 28, 2022 P&S