Maia Biotechnology, Inc. · AMEX:MAIA
Maia Biotechnology — IPO Roadshow (June 2023)
34 slides from Maia Biotechnology's IPO roadshow presentation, Jun 9, 2023
Slide 1: Telomere Targeting Immunotherapies for Cancer
TELOMERE TARGETING IMMUNOTHERAPIES FOR CANCER NYSE AMERICAN: MAIA June 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 p
Slide 4: Investment Overview
INVESTMENT OVERVIEW • Telomere-Targeting Agents: o THIO in clinic o Advancing pipeline • Efficacy • Safety • FDA: 2 Orphan Drug Designations (HCC and SCLC) • REGN: Clinical Supply Agreement • Phase 2 Go-to-Market Accelerated Approval THIO-101 trial in NSCLC underway o Enrolling in AUS and EU o On tr
Slide 5: Robust Pipeline
ROBUST PIPELINE COLLABORATION & PRECLINICAL PHASE 1 PHASE 2 PHASE 3 RIGHTS THIO Telomere targeting agent Worldwide rights Ph 2 Enrolling THIO-101 NSCLC THIO → Libtayo owned by MAIA July 2022 Ph 2 Worldwide rights THIO-102 CRC, HCC, ST THIO → CPI Planning owned by MAIA Worldwide rights Ph 2/3 THIO-10
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
MAIA MISSION AND APPROACH
Slide 8: Cancer is the most dominant age-related disease
Population aged >80 expected to triple by Cancer is the 2050 most dominant age-related 142 disease million 426 Cancer is the most dominant of the age-related disease categories and has 2020 At age 90: life altering impacts in the lives of patients and their close ones million 40% will be diagnosed 2
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 99
Slide 10: THIO - Mechanisms of Action
THIO - MECHANISMS OF ACTION THIO CPIs THIO has a dual MoA: 3 Checkpoint Inhibitors Telomere targeting 1 Chromosome Telomere 2 Immunogenic effect (cemiplimab) (pembrolizumab) (atezolizumab) (nivolumab) (durvalumab) Partnership with REGN for NSCLC 10
Slide 11: Regeneron Agreement
REGENERON AGREEMENT MAIA & REGENERON BIOTECHNOLOGY MAIA Biotechnology, Inc. Announces Clinical Supply Agreement with Regeneron for Phase 1/2 Clinical Trial Evaluating THIO in Sequential Administration with Libtayo® (cemiplimab) in Advanced Non-Small Cell Lung Cancer
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 / Part C*: Dose Selection Registration Currently enrolling Every 3 Weeks THIO 60mg (N
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 11 and 10 months respectively, from treatment initiation • Both patients have advanced Stage IV metastatic disease and are heavily pretreated, receiving third and fourth line of thera
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 *Cut off date of 30May2023 10-015 for subjects on treatment and 10-019 in follow up 10-027 13-022 14-020 = On treatment 14-021 13-025 = In Follow Up 10-030 = Date of last dose if off 14-028 treatme
Slide 17: THIO-101 - Rationale
THIO-101 – RATIONALE Control • THIO followed by CPI results in 1000 Atezolizumab 60% complete response THIO 900 THIO → Atezo • No recurrence after long-term 800 No cancer follow-up 700 immune memory • Anticancer immune memory has 600 due to THIO been induced: no cancer after Rechallenge with 500 rec
Slide 18: THIO-101 - Non-Small Cell Lung Cancer
THIO-101 – NON-SMALL CELL LUNG CANCER • Target: 20% improvement Current SoC Catalyst Timing on Standard of Care (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), 2024 4-4.5m PFS (Progression Free Survival
Slide 19: Biomarker - TIFs
BIOMARKER – TIFS (TELOMERE DYSFUNCTION INDUCED FOCI) Confocal microscopy image of LLC cell Quantification of TIFs induced nucleus after treatment with THIO in LLC cell by 3 µM of THIO DAPI γH2AX Tel C THIO • Yellow dots indicated TIFs by THIO • TIFs induction reached max after ~ 48h • Green dots - γ
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 TECENTRIQ (atezolizumab) 1 CRC LIBTAYO (cemiplimab) THIO K
Slide 21: THIO-102 Trial - Colorectal Rationale
THIO-102 TRIAL – COLORECTAL RATIONALE 700 Control 600 Atezolizumab • THIO followed by CPI results in 500 THIO 100% complete response 400 THIO → Atezo 300 • No recurrence after long-term 200 follow-up 100% CR 100 • Anticancer immune memory 0 0 10 20 has been induced: no cancer Days After Tumor Inocul
Slide 22: THIO-102 Trial - Colorectal
THIO-102 TRIAL - COLORECTAL Current SoC • Target: 20% improvement on Catalyst Timing (Chemo) Standard of Care (SOC) 50-60% Toxicity 2024 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 HCC SCLC 1500 1500 Control Control 1250 1250 THIO Pembro → THIO 1000 1000 THIO → IR THIO → Pembro 750 750 IR + Atezo THIO → IR + Atezo 500 500 250 250 0 0 0 5 10 15 20 25 0 5 10 15 20 25 Days After Tumor Inoculation Days After Tumor Inoculation • 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 HCC • When combined with immunotherapy checkpoint inhibitor Libtayo®, duration of response was further potentiated • Upon rechallenge with two times more cancer cells and no additional treatment, tumor growth HCC Rechallenge with was completely prevented 2x more HCC cel
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 Part A/B: Safety/Efficacy Signal Part C: Pivotal Phase 3 Baskets 1 SCLC First Line EP + TECENTRIQ (atezolizumab) THIO Expand to Pivotal P
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 Mihail Obrocea, MD Sergei Gryaznov, PhD Joe McGuire Founder, Chairman, and Chief Medical Officer Chief Scientific Officer Chief Financial Officer Chief Executive Officer • 22+ years in Oncology Pharma/ • Hematologist/Oncologist • 25+ years as Scientist
Slide 29: Capitalization Table & Cash Balance
CAPITALIZATION TABLE & CASH BALANCE Capitalization Table (as of 6/7/2023) Common stock 13,625,925 1 Options (WAEP: $2.67) 7,741,123 Warrants (WAEP: $5.59) 924,760 Fully Diluted Shares Outstanding 22,291,810 2 Cash Balance of $9.57 million (as of 6/7/2023) 1 5,136,153 options held by directors and of
Slide 30: Investment Opportunity
INVESTMENT OPPORTUNITY 30 30
Slide 31: Significant Market Opportunity
SIGNIFICANT MARKET OPPORTUNITY Developing agents for the top tumor types $42B combined markets globally NSCLC #1 WW CRC #2 WW Mortality: 1.7M Mortality: 1.0M Sales: $ 34B Sales: $ 20B $42B CPIs Group • 5 CPIs approved for NSCLC sold $12B • >30% of NSCLC drug sales $0.5B • >40% of total CPI sales Cat
Slide 32: Comparable Companies
COMPARABLE COMPANIES $34M $2.4B $1.5B $1.8B $0.9B $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 32 Market Caps as of June 6, 2023 (source: S&P CapitalIQ)
Slide 33: Multiple Value-Driving Milestones
MULTIPLE VALUE-DRIVING MILESTONES Potential Accelerated Approval in US • Major inflection points Filing for US approval THIO-101 THIO-101 OS DoR, PFS THIO-103 Ph 2/3 SCLC, NSCLC First Line THIO-102 THIO-101 Ph 2 CRC, HCC, ST ORR THIO-101 THIO-101 IND filing Safety Data 33 33 2023 2024 2025
Slide 34: MAIA Biotechnology Listed July 28, 2022
MAIA BIOTECHNOLOGY LISTED NYSE: MAIA July 28, 2022 34