Maia Biotechnology, Inc. · AMEX:MAIA
Maia Biotechnology — Investor Presentation (September 2022)
29 slides from Maia Biotechnology's investor presentation, Sep 7, 2022
Slide 1: Telomere Targeting Immunotherapies for Cancer
Telomere Targeting Immunotherapies for Cancer NYSE American: MAIA September 2022 Exhibit 99.1
Slide 2: 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 projections of results of
Slide 3: Company Overview: Pipeline and Science
PIPELINE SCIENCE Telomerase is an enzyme that is present in a majority of human cancer cells (over 85% in the aggregate), across various tumor types Company Overview 3 1 Published in Cancer Cell, see slides 28-30, below 2 Nobel Prize awarded in 2009 to Jack Szostak, Elizabeth Blackburn and Carol Gre
Slide 4: Basis for New Treatment Approach: THIO dual mechanism of action
Basis for New Treatment Approach Direct Telomere-Targeting: Lead to Cancer Cell Death1 Immunogenic Effect: Anti-Tumor Immune Activation (in vivo2) THIO: Dual mechanism of action In VIVO 1 In Preclinical Studies 2 In Rodent Preclinical Studies Lead to Cancer Cell Death1 1 THIO metabolized and utilize
Slide 5: Pipeline
Pipeline THIO Telomere targeting agent THIO-101 Non-Small Cell Lung Cancer (NSCLC) THIO Libtayo 2nd Generation Telomere targeting agents Phase 2 Enrolling July 2022 THIO-1021 Colorectal, HCC, Small Cell Lung Cancer THIO CPI THIO-1032 Confirmatory/Definitive Approval Basket Study THIOCPI Phase 2
Slide 6: Goal of Study: New Standard of Care for Treatment of NSCLC
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-PD1) Development exclusivity only for NSCLC for
Slide 7: 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) THIO-101 Study: Phase 2 in Advanced NSCLC ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT05208944?term=05208944&draw=2&rank=1 THIO-101 Stud
Slide 8: THIO-101 Study in NSCLC: Anticipated Clinical Outcomes
Mender et al, Cancer Cell, 2020 THIO-101 Study IN NSCLC: anticipated CLINICAL OUTCOMES EXTRAPOLATED FROM PRECLINICAL DATA THIO-101 Study IN NSCLC: anticipated CLINICAL OUTCOMES EXTRAPOLATED FROM PRECLINICAL DATA MAIA BIOTECHNOLOGY 8 Catalyst Timing Current SOC (chemo) THIO LIBTAYO (expected) Safety
Slide 9: Biomarker of On-Target Biological Activity: TIFs
BIOMARKER OF ON-TARGET BIOLOGICAL ACTIVITY: TIFS DAPI γH2AX Tel C 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 THIO THIO induced telomere dysfunction in Lewis Lung Carcinoma (LLC) cells: in vitro NSCLC mode
Slide 10: THIO-102 Study: Planned Phase 2 in Three Cancer Indications
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 Patients with Telomerase Positive Cancers THIO TBD mg/cycle (QD D1-3)1 ORR 20% N = 10 Tx ARMS CRC-3+ mtKRAS MSS Immunotherapy (CPIs) Immune Activation D4 Q3W,
Slide 11: THIO-102 Trial: Catalysts and Rationale for the CRC arms
TRF2 Gamma- H2AX TIF CRC (HCT116) Cells THIO-102 TRIAL: Catalysts AND RATIONALE for the CRC arms
Slide 12: Multiple Value-Driving Milestones
Q2 FDA Orphan Drug Designations HCC and SCLC Q3-Q4 THIO-101 Safety Data Q4-Q1 2023 Prelim Efficacy Data THIO-101 1H Ph 2/3 THIO-103 Basket Study First Line in Multiple Solid Tumors Potential Accelerated Approval in US 2H Ph 2 THIO-102 Basket/Umbrella Study CRC, HCC, SCLC 2H THIO-101 IND filing (plan
Slide 13: Immune Checkpoint Inhibitors Market: Significant Market Opportunity
Immune Checkpoint Inhibitors Market 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 Immune Checkpoint Inhibitors Market Checkpoint Inhibitors $34.0bn combined
Slide 14: 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 1 issued US patent 3 issued foreign patents 5 pend
Slide 15: Comparable Companies Market Caps
Comparable companies Market Caps as of August 23, 2022 (source: S&P CapitalIQ) 15 * On June 3, 2022, Bristol Myers Squibb announced the acquisition of Turning Point Therapeutics in an all-cash transaction for $4.1 Billion in equity value.
Slide 16: Capitalization Table & Cash Balance
Capitalization Table & CASH BALANCE 3,881,754 options held by directors and officers Note: Directors and officers, and their affiliates, own 42% of the 17,660,412 fully diluted shares outstanding Cash Balance of $8,150,012 (as of 6/30/2022) IPO completed on August 1, 2022 Gross proceeds of $11.5 mil
Slide 17: Management Team
22+ yrs. Pharma/Biotech: Commercial, Medical, 12 compounds launched, 20+ tumor types, 8 Oncology companies. Served in Oncology leadership roles at Cephalon (Treanda), Astellas (Tarceva, Xtandi), Bayer (Nexavar), Novartis (Zometa), and Incyte (Jakafi) 25+ yrs. Scientist/Expert Drug Discovery and Deve
Slide 18: Investment Highlights
Investment Highlights 18 Investment Highlights Two Clinical Programs – Ph 2 THIO-101 in NSCLC: THIO + Libtayo® (cemiplimab) Regeneron; Enrolling – Ph 2 THIO-102 in CRC, HCC, and SCLC: THIO + CPIs; Planned 2023 THIO is a Unique Direct Telomere Targeting Agent – Potential to be used in combination wit
Slide 19: Telomere Targeting Immunotherapies for Cancer
Telomere Targeting Immunotherapies for Cancer August 2022
Slide 20: Scientific Advisors
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 credentialed in both pediatric and adult neuro-on
Slide 21: Telomeres: Key Therapeutic Targets for Cancer
Telomeres: Key Therapeutic Targets for Cancer Source: Adapted from Cell , Volume 144, Issue 5, Pages 646-674 (DOI:10.1016/j.cell.2011.02.013) EGFR inhibitors Cyclin-dependent kinase inhibitors Inhibitors of HGF/c-Met Inhibitors of VEGF signaling Selective anti-inflammatory drugs PARP inhibitors Telo
Slide 22: THIO in brain tumor models: BBB penetration and tumor inhibition
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 Demonstrated Increased Survival in Brain Cancer Mouse Model Observed Evidence of Telomere Dysfunction T
Slide 23: 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) Telomeric DNA is ~1/6000 of total genomic DNA; thus, any telomeric co-localization with DNA damage is highly significant. Preclinical Results Show that TH
Slide 24: 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 MoA Biomarkers of THIO’s Immunological Activity In Vitro
Slide 25: New Results about Immunogenic Effects of THIO Published in Cancer Cell
“Telomere Stress Potentiates STING-Dependent Anti-tumor Immunity,” was authored by researchers at the University of Texas Southwestern. A key peer-reviewed publication released online in the renowned journal Cancer Cell on July 2, 2020. Key Takeaways Researchers concluded that THIO-targeted telomere
Slide 26: THIO Induction of Systemic Anti-tumor Immunity in 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 THIO Induction of Systemic Anti-tumor Immunity in Colorectal Cancer (CRC) In Vivo
Slide 27: THIO Induction of Systemic Anti-tumor Immunity in CRC In Vivo
THIO followed by PD-L1 blockade in MC38 cells in murine model was curative, accompanied by generation of immune memory THIO Induction of Systemic Anti-tumor Immunity in Colorectal Cancer (CRC) In Vivo
Slide 28: THIO Sequential with PD-L1 Antibody in Lung Cancer In Vivo
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
Slide 29: Extensive Studies with Established Activity and Safety Profile
IN VIVO: IN VITRO: Extensive Studies with Established Activity and Safety Profile *Detailed data sets for in vivo/in vivo studies are available for further reviews Extensive Studies with Established Activity and Safety Profile \THIO has been shown to be synergistic in vivo with immune checkpoint inh
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