Maia Biotechnology, Inc. · AMEX:MAIA
Maia Biotechnology — IPO Roadshow (July 2023)
35 slides from Maia Biotechnology's IPO roadshow presentation, Jul 11, 2023
Slide 1: Telomere Targeting Immunotherapies for Cancer
TELOMERE TARGETING IMMUNOTHERAPIES FOR CANCER NYSE AMERICAN: MAIA July 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 US IN
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 & Feb 2, 2021 11
Slide 12: THIO-101 Trial: Patients Dosed To-Date
THIO-101 TRIAL: 35 PATIENTS DOSED TO-DATE 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 / Planned Expansion: Dose Selection Registration* Completed Currentl
Slide 13: Favorable Safety Profile
FAVORABLE SAFETY PROFILE • Safety events reported during dose-limiting toxicity window • 360 mg/cycle – THIO highest dose • Data from 9 patients who completed the dose-limiting toxicity (DLT) period in Cycle 1 (3 weeks) • Safety profile substantially better than current standard of care o Chemothera
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 12.2 and 11.5 months respectively, from treatment initiation • Both patients have advanced Stage IV metastatic disease and are heavily pretreated, receiving third line of therapy afte
Slide 16: Disease Control Rate (DCR)
DISEASE CONTROL RATE (DCR) • All subjects with at least 1 post-baseline response assessment recorded in the database through 23-Jun-2023 (n=11) • DCR: 82% (9/11) • DCR = Overall Response Rate (ORR) + Stable Disease (SD) • DCR is a better surrogate than ORR for increased survival benefit in later lin
Slide 17: Preliminary Survival Data
PRELIMINARY SURVIVAL DATA Survival from C1D1 01-003 12.2 months * 02-002 * 11.5 months 17-006 17-007 14-008 14-009 10-010 10-011 Cut off date of 10Jul23 08-012 14-013 for subjects who have 10-014 received at least 1 dose 10-015 10-019 of THIO and are still on 10-027 treatment or considered 13-022 14
Slide 18: 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 19: THIO-101 - Target Profile
THIO-101 – TARGET PROFILE • Target for Accelerated Approval Current SoC Catalyst in Second-Line NSCLC: (Chemo)* o 35% ORR Toxicity Grd ≥ 3 : 72-79% o 6 months DoR ORR (Overall Response Rates) 11-23% • Target for Standard Approval: CR (Complete Response) 0% o 20% improvement of OS vs. SoC PFS (Progre
Slide 20: 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 21: 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 22: 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 23: THIO-102 Trial - Colorectal
THIO-102 TRIAL - COLORECTAL • Target for Accelerated Approval Catalyst Current SoC (Chemo)* in Third-Line CRC: o 10% ORR Toxicity Grd ≥ 3: 50-60% o 4 months DoR ORR 1.6% • Target for Standard Approval: o 20% improvement of OS vs. SoC PFS 2m OS 7.2m 23 * LONSURF (trifluridine/tipiracil) RECOURSE regi
Slide 24: 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 25: 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 25
Slide 26: 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 27: 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 28: 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 29: 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 30: 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 31: Investment Opportunity
INVESTMENT OPPORTUNITY 31 31
Slide 32: 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 33: Comparable Companies
COMPARABLE COMPANIES $31M $2.3B $1.9B $1.9B $0.7B $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. 33 33 Market Caps as of July 10, 2023 (source: S&P CapitalIQ)
Slide 34: Multiple Value-Driving Milestones
MULTIPLE VALUE-DRIVING MILESTONES Potential Accelerated Approval in US • Major inflection points Filing for US approval THIO-101 OS THIO-101 THIO-101 DOR THIO-103 Ph 2/3 PFS SCLC, NSCLC THIO-102 Ph 2 First Line THIO-101 CRC, HCC, ST (Q4 2023) Preliminary ORR (Q4 2023) (Q4 2023) THIO-101 IND filing (
Slide 35: MAIA Biotechnology Listed
MAIA BIOTECHNOLOGY LISTED NYSE: MAIA July 28, 2022 35