Maia Biotechnology, Inc. · AMEX:MAIA
Maia Biotechnology — IPO Roadshow (April 2023)
32 slides from Maia Biotechnology's IPO roadshow presentation, Apr 11, 2023
Slide 1: Telomere Targeting Immunotherapies for Cancer
TELOMERE TARGETING IMMUNOTHERAPIES FOR CANCER NYSE AMERICAN: MAIA April 2023
Slide 2: Free Writing Prospectus
2 This presentation highlights basic information about us and the proposed offering. Because it is a summary, it does not conta in all of the information that you should consider before investing. We have filed a registration statement (including a prospectus) wi th the SEC for the offering to which
Slide 3: Forward-looking statements
3 All statements in this presentation, other than those relating to historical facts, are "forward - looking statements." These forw ard - looking statements may include, but are not limited to, statements relating to our objectives, plans, and strategies; statements that contain projections of resu
Slide 4: Investment Overview
4 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
Slide 5: Robust Pipeline
5 ROBUST PIPELINE THIO Telomere targeting agent THIO - 101 NSCLC THIO à Libtayo 2 nd Generation Telomere targeting agents Ph 2 Enrolling July 2022 THIO - 102 CRC , HCC, ST THIO CPI THIO - 103 NSCLC, SCLC First Line Ph 2 Planning Ph 2/3 Planning MAIA - 2021 - 20 Multiple Indications MAIA - 2022 - 12
Slide 6: Science Overview: THIO Telomere Targeting Agent
6 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, DIPG, MB)
Slide 7: Mission and Approach
MISSION AND APPROACH (Wi) MALA
Slide 8: Cancer is the most dominant age-related disease category
8 Cancer is the most dominant of the age - related disease categories and has life altering impacts in the lives of patients and their close ones Population aged >80 expected to triple by 2050 2020 2050 Cancer is the most dominant age - related disease At age 90: 40% will be diagnosed 20% will die o
Slide 9: THIO is the only direct telomere targeting agent in clinical development
9 THIO is the only direct telomere targeting agent currently in clinical development
Slide 10: THIO - Checkpoint Inhibitors
10 THIO - CHECKPOINT INHIBITORS THIO CPIs A black and white logo Description automatically generated with low confidence ( cemiplimab ) (pembrolizumab) ( atezolizumab ) (nivolumab) ( durvalumab ) THIO has a dual MoA : Telomere targeting Immunogenic effect Checkpoint Inhibitors 1 2 3 Partnership with
Slide 11: Regeneron Agreement
REGENERON AGREEMENT Company Logo MAIA Biotechnology, Inc. Announces Clinical Supply Agreement with Regeneron for Phase 1/2 Clinicl Trail Evaluating THIO in Sequential Administration with Libtayo® (cemiplimab) in Advanced Non-Small Cell Lung Cancer 11
Slide 12: THIO: Clinical Development Strategy
12 THIO: CLINICAL DEVELOPMENT STRATEGY
Slide 13: Clinical Development Overview
13 THIO - 101 Ph 2 trial THIO → LIBTAYO® • Go - to - Market • NSCLC Second Line • REGN supply agreement • Enrolling at multiple sites in AUS and EU (2022) • File US IND and commence enrolling in US in 2023 • Select optimal dose and expand • File for accelerated approval (2025) THIO - 102 Ph 2 trial
Slide 14: THIO-101 Trial (Ongoing)
14 Primary Endpoints Safety, ORR Secondary Endpoints DCR (CR, PR or SD); DoR ; PFS; OS Exploratory Endpoints PK and PD (activity of THIO in circulating tumor cells measured by specific biomarkers) THIO 60mg (N=19) ORR, DCR N ≤ 41 per Arm THIO 360mg (N=19) THIO 180mg (N=19) c emiplimab NSCLC 2L+ Immu
Slide 15: Favorable Safety Profile
15 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
Slide 16: Favorable Safety Profile: Adverse Events
16 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 **R
Slide 17: THIO Rationale: Lung Cancer Rechallenge
17 THIO - 101 – RATIONALE Rechallenge with 5x more lung cancer cells with no additional treatment No recurrence No cancer immune memory due to THIO 20% PR 60% CR Mender et al, Cancer Cell, 2020; THIO followed by Tecentriq (atezolizumab; Roche/Genentech) tested first; repeated later with THIO followe
Slide 18: THIO Non-Small Cell Lung Cancer Catalysts
18 THIO - 101 – NON - SMALL CELL LUNG CANCER 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 - 4.5m OS (Overall Survival) 2025 8.1 - 10
Slide 19: Biomarker: TIFs
19 BIOMARKER – TIFS (TELOMERE DYSFUNCTION INDUCED FOCI) DAPI γH2AX Tel C Confocal microscopy image of LLC cell nucleus after treatment with THIO Quantification of TIFs induced in LLC cell by 3 µM of THIO THIO • Yellow dots indicated TIFs by THIO • Green dots - γ H2AX • Red dots - telomeres • TIFs in
Slide 20: THIO-102 Trial (Planned)
20 Baskets Umbrella Arms Immune Activation Part A/B: Safety/Efficacy Signal Part C: Pivotal Phase 2 THIO 1 THIO 1 CRC HCC 1 Dose to be selected from THIO - 101 study results 2 E.g. Breast, Prostate, Gastric, Pancreatic, Ovarian, etc THIO 1 Solid Tumors 2 Expand Best Combination Arms THIO (d1 - 3) +
Slide 21: THIO Colorectal Rationale
21 THIO - 102 TRIAL – COLORECTAL RATIONALE 100% CR Rechallenge with 10x more CRC cells with no additional treatment No recurrence 100% CR No cancer immune memory due to THIO Mender et al, Cancer Cell, 2020 • THIO followed by CPI results in 100% complete response • No recurrence after long - term fol
Slide 22: THIO Colorectal Catalysts
22 THIO - 102 TRIAL - COLORECTAL 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 • Target: 20% improvement on Standard of Care (SOC)
Slide 23: SCLC & HCC: Orphan Drug Designation
23 SCLC & HCC – ORPHAN DRUG DESIGNATION • THIO is synergistic with anti - PD - 1 agent Pembrolizumab in Small Cell Lung Carcinoma (H2081 ) in vivo in humanized murine cancer model. • Treatment with THIO followed by Pembrolizumab results in highly potent anticancer effect, as compared to Pembrolizuma
Slide 24: THIO-103 Trial (Planned)
24 THIO 1 Baskets SCLC First Line Immune Activation Part A/B: Safety/Efficacy Signal Part C: Pivotal Phase 3 THIO 1 NSCLC First Line 1 Dose to be selected from THIO - 101 study results EP + TECENTRIQ (atezo lizumab) A Multicenter , Open - label, Phase 2 Trial Evaluating the Safety and Efficacy of TH
Slide 25: Exclusivity and Intellectual Property
25 Goal: New Chemical Entity (NCE) Marketing Exclusivity Robust and Growing Patent Portfolio for THIO • 1 issued US patent • 4 issued foreign patents • 5 pending US patent applications • 7 pending foreign patent applications Current patents/provisional applications broadly cover the following key ar
Slide 26: Management Team
26 • 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 ( Zometa ), and Incyte (Jakafi) • 25+ years as Scientist • Expert Drug Discovery and De
Slide 27: Capitalization Table & Cash Balance
27 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 CAPITALIZATION TABLE & CASH BALANCE 1 4,282,309 options held by directors and officers Note: Directors and officers, and the
Slide 28: Investment Opportunity
INVESTMENT OPPORTUNITY (Wi) MALA
Slide 29: Significant Market Opportunity
29 Keytruda® (pembrolizumab) Opdivo ® (nivolumab) Tecentriq ® ( atezolizumab ) Imfinzi ® ( durvalumab ) Libtayo ® (cemiplimab) SIGNIFICANT MARKET OPPORTUNITY NSCLC #1 WW Mortality: 1.7M Sales: $ 3 4B • 5 CPIs approved for NSCLC sold $12B • >30% of NSCLC drug sales • >40% of total CPI sales • Keytrud
Slide 30: Comparable Companies
30 $38M $2.2B $1.1B $1.3B $0.8B $4.1B Turning Point Therapeutics Announces Pricing of Initial Public Offering | Business Wire Mirati Therapeutics Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4) Zentalis Pharmaceuticals COMPARABLE COMPANIES 30 • On June 3, 2022, Bristol Myers Squibb ann
Slide 31: Multiple Value-Driving Milestones
31 THIO - 101 Safety Data THIO - 101 ORR THIO - 103 Ph 2/3 SCLC, NSCLC First Line Potential Accelerated Approval in US THIO - 102 Ph 2 CRC, HCC, ST THIO - 101 IND filing THIO - 101 OS THIO - 101 DoR , PFS MULTIPLE VALUE - DRIVING MILESTONES 2023 2025 Filing for US approval 2024 • Major inflection po
Slide 32: MAIA Biotechnology Listed July 28, 2022
32 MAIA BIOTECHNOLOGY LISTED NYSE: MAIA July 28, 2022