Lite Strategy, Inc. · NASDAQ:LITS
Lite Strategy — MEI Pharma — Merger or Acquisition (February 2023)
39 slides from Lite Strategy's merger presentation, Feb 23, 2023
Slide 1: MEI Pharma and Infinity Pharmaceuticals Announce Definitive Merger Agreement
February 23, 2023 MEI Pharma and Infinity Pharmaceuticals Announce Definitive Merger Agreement to Advance 3 Promising Clinical Oncology Candidates Exhibit 99.2
Slide 2: Cautionary Statement Regarding Forward-Looking Statements
Cautionary Statement Regarding Forward-Looking Statements Certain statements contained in this filing may be considered forward-looking statements within the meaning of the federal securities law. Such statements are based upon current plans, estimates and expectations of the management of MEI and I
Slide 3: Additional Information
Additional Information Important Information about the Merger and Where to Find It This communication relates to a proposed transaction between Infinity Pharmaceuticals, Inc. (“Infinity”) and MEI Pharma, Inc. (“MEI”). In connection with the proposed merger, MEI and Infinity plan to file with the SEC
Slide 4: NewCo: Complementary Pipeline, Teams and Resources
Early Clinical Studies Later Stage Clinical Studies Company Infrastructure and Balance Sheet NewCo Voruciclib in AML ME-244 in CRC Clinical Data End 2023 Eganelisib in SCCHN Initial Safety and Efficacy, 2H 2024 ~ 50 people Cash runway to mid 2025 Data on All 3 Programs Expand and Diversify Product P
Slide 5: NewCo: Complementary Pipeline, Teams and Resources
Early Clinical Studies Later Stage Clinical Studies Company Infrastructure and Balance Sheet NewCo Voruciclib in AML ME-244 in CRC Clinical Data End 2023 Eganelisib in SCCHN Initial Safety and Efficacy, 2H 2024 ~ 50 people Cash runway to mid 2025 Data on All 3 Programs Expand and Diversify Product P
Slide 6: Combined Company: Anticipated Events and Timings
Early Clinical Studies Later Stage Clinical Studies Company Infrastructure and Balance Sheet Combined Company (Anticipated events and timings) Voruciclib in AML ME-344 in CRC Top Line Results YE 2023 Eganelisib in HNSCC Initial Safety and Efficacy, 2H 2024* Cash Runway to mid 2025, Data Expected on
Slide 7: A Combined Company with Significant Opportunities for Value Creation
A Combined Company with Significant Opportunities for Value Creation Experienced Leadership Team Three differentiated, promising, clinical candidates based on solid science and data Pipeline led by planned eganelisib Phase 2 HNSCC Study* Expected Funding though mid-2025 and clinical data over the ne
Slide 8: Leadership with Extensive Industry and Oncology Drug Development Expertise
Leadership with Extensive Industry and Oncology Drug Development Expertise EXECUTIVE LEADERSHIP David Urso, Chief Executive Officer Robert Ilaria, Jr., MD, Chief Medical Officer Stéphane Peluso, PhD, Chief Scientific Officer BOARD David Urso Adelene Perkins Daniel Gold, PhD Richard Gaynor, MD Norman
Slide 9: Clinical-Stage Oncology Programs Expected to be Funded Through Mid-2025
3 Clinical-Stage Oncology Programs Expected to be Funded Through Mid-2025 INVESTIGATIONAL AGENTS THERAPEUTIC AREA COMBINATION PHASE 1/1B PHASE 2 PHASE 3 Initial Clinical Data* Eganelisib Oral PI3K Gamma Inhibitor Head & Neck Squamous Cell Carcinoma1 1L Recurrent KEYTRUDA® 2H 2024 Voruciclib Oral CDK
Slide 10: Transaction Structure
Transaction Structure Stock-for-stock merger: Infinity stockholders will receive shares of MEI common stock Infinity will become a wholly owned subsidiary of MEI pharma Pro forma outstanding equity of the combined company post-closing: Approximately 58% MEI and approximately 42% Infinity Combined co
Slide 11: Eganelisib, PI3K-gamma Inhibitor for Next Generation Cancer Immunotherapy
Eganelisib, PI3K-�� Inhibitor for Next Generation Macrophage Reprogramming Cancer Immunotherapy Evans et al ACS Med Chem Let 2016 7 862
Slide 12: PI3K-gamma is Differentiated from Other PI3K Isoforms
Myeloid cells B cells and T-cells Ubiquitous Ubiquitous Immune cell trafficking Macrophage polarization B-cell and T-cell activation and function Platelet activation Insulin signaling Insulin signaling KO viable, immunodeficiency and immunopathology phenotype KO viable, immunodeficiency and immunopa
Slide 13: Eganelisib, a Potential First-in-Class, Selective PI3K-gamma Inhibitor
Cellular IC50 pAKT IC50 (nM) Eganelisib, a Potential First-in-Class, Selective PI3K-g Inhibitor with a Strong Scientific Foundation as a Next Generation Cancer Immunotherapy Evans et al ACS Med Chem Let 2016 7 862 │ McGovern et al. AACR-NCI-EORTC 2015 #A192 │ Kaneda et al. Nature 2016 539 437 │ De H
Slide 14: TAM Reprogramming with Eganelisib
TAM* Reprogramming with Eganelisib Designed to Reshape the Immunosuppressive Tumor Microenvironment to Enhance Immune Checkpoint Inhibitors Activity Suppressed T cells M2-like Macrophages Growing Tumor Cells M1-like Macrophages Activated T Cells Dying Tumor Cells Molgora & Colonna Med 2021 2 666 | C
Slide 15: MARIO Clinical Program Has Demonstrated Eganelisib Clinical Activity
PHASE 1 PHASE 1B PHASE 2 Key Study Data MARIO Clinical Program has Demonstrated Eganelisib Clinical Activity Across Multiple Combinations and Tumor Types MARIO-275 CPI Naïve 2nd Line Urothelial Cancer, Randomized Study Eganelisib + Opdivo vs Opdivo + placebo 1. November 30, 2021 data snapshot; 1a. J
Slide 16: MARIO Clinical Program Has Demonstrated Eganelisib Clinical Activity
PHASE 1 PHASE 1B PHASE 2 Key Study Data CPI Naïve 2nd Line Urothelial Cancer, Randomized Study Eganelisib + Opdivo vs Opdivo + placebo Progressed on Immediate Prior CPI Advanced Solid Tumors (Head & Neck Cohort): Eganelisib + Opdivo Eganelisib + CPI MARIO Clinical Program has Demonstrated Eganelisib
Slide 17: MARIO-275: Eganelisib Added to Nivolumab in 2L Urothelial Cancer
MARIO-275: Addition of Eganelisib to Standard of Care Nivolumab in CPI-Naïve Platinum Refractory 2L Urothelial Cancer Patients, Including PD-L1(-) Patients Eganelisib 40/30mg QD** + Nivolumab 480 mg Q4W Placebo + Nivolumab 480 mg Q4W Advanced Platinum Refractory 2nd Line Urothelial Cancer Patients M
Slide 18: MARIO-275: TEAEs Leading to Treatment Discontinuation
MARIO-275: TEAEs* Leading to Treatment Discontinuation of Eganelisib/Placebo and/or Nivolumab Hepatic TEAEs No Hy’s Law No grade 5 hepatic TEAE All hepatic Grade ≥3 TEAEs resolved in the combination arm except 2 One patient had grade 3 hepatotoxicity and subsequently died due to disease progression
Slide 19: MARIO-275: Translational Data Showed Enhanced Immune Activation
*p<.05 Two-Way ANOVA log2FC from baseline Concentration (pg/mL) Day 0 Day 15 Day 0 Day 15 * * NS IFN-�� Responsive Cytokines CXCL10 Similar results for CXCL9 (not shown) MARIO-275: Translational Data Showed Enhanced Immune Activation With Eganelisib + Nivolumab Versus Placebo + Nivolumab in Peripher
Slide 20: MARIO-275: ITT Two-Year Landmark Survival Analysis
MARIO-275: ITT Two-Year Landmark Survival Analysis: 45% of Patients in the Eganelisib + Nivolumab Arm Alive vs 24% of Patients in the Nivolumab Control Arm Overall Survival Results: ITT HR of 0.58 (0.2737, 1.2394) Indicating 42% Reduction of Risk of Death Eganelisib + Nivolumab Placebo + Nivolumab P
Slide 21: MARIO-1: Eganelisib + Nivolumab After Progression on Prior CPI Therapy
1st Line Chemo “X” 2nd Line Chemo “Y” 3rd Line Immediate Prior Checkpoint Inhibitor IPI-549 + Checkpoint Treatment Stable Disease Partial Response Progressive Disease Eganelisib Benefit MARIO-1 Study Start PD Progressive Disease PD PD PD Tumor Burden Study design examines the activity of eganelisib
Slide 22: MARIO-1: Reversible Hepatic and Skin AEs Most Common Toxicities
MARIO-1: Reversible Hepatic and Skin AEs* were the Most Common Toxicities Observed When Eganelisib was Combined with Nivolumab n (%) Eganelisib dose escalation + nivolumab (Part C) Eganelisib + nivolumab dose expansion (Parts E-H) 40 mg (n=149) 20 mg (n=7) 30 mg (n=12) 40 mg (n=12) Any grade G ≥ 3 A
Slide 23: MARIO-1: Activity of Eganelisib with Opdivo in HNSCC Patients
MARIO-1: Activity of Eganelisib in Combination with Opdivo in HNSCC Patients Having Progressed on Immediate Prior CPI Therapy 2 or fewer prior therapies 3 or more prior therapies Best % Change in Target Lesion Size from Baseline mPFS in Keynote -048* for Pembro monotherapy in local recurrent pts = 2
Slide 24: Eganelisib Next Step: Randomized, Controlled Phase 2 Study in Head & Neck Cancer
Eganelisib Next Step: Randomized, Controlled Phase 2 Study in Head & Neck Cancer Patients Rationale to Conduct a Global Phase 2 HNSCC Study Encouraging PFS data in MARIO-1 HNSCC patients having progressed on immediate prior CPI Clear medical need: poor survival -- median is 12.3 months* alone or in
Slide 25: Eganelisib Summary
Eganelisib Summary Highly specific, potential first-in-class, daily, oral small molecule inhibitor of PI3K-g Pre-clinical and clinical translational data support macrophage reprogramming-mediated immune activation Data support rationale for combination with PD-1/PD-L1 inhibitors Demonstrated clinica
Slide 26: Voruciclib: Oral CDK9 Inhibitor
Voruciclib: Oral CDK9 Inhibitor
Slide 27: Voruciclib is an Orally Administered CDK9 Inhibitor
Voruciclib is an Orally Administered CDK9 Inhibitor: At the Axis of Cell Proliferation Regulation Increased MCL1 is an established venetoclax resistance mechanism Venetoclax inhibits BCL2 but can lead to stabilization of MCL1 Voruciclib inhibits MCL1 via CDK9 inhibition CDK9 Regulates MCL1 and MYC M
Slide 28: Phase 1 Study: Voruciclib + Venetoclax in AML and B-cell Malignancies
Phase 1 Study: Voruciclib + Venetoclax in AML and B-cell Malignancies Endpoints Safety and tolerability Pharmacokinetics Biologic correlative studies BH3 profiling, MCL-1 expression (Dana Farber) Molecular mutations analysis (City of Hope) Response rates Voruciclib Monotherapy dose escalation/optimi
Slide 29: Monotherapy Safety Profile Does Not Suggest Overlapping Toxicity with Venetoclax
Monotherapy Safety Profile Does Not Suggest Overlapping Toxicity with Venetoclax in Patients with AML or B-cell Malignancies n (%) Group I (n=16) Group II (n=13) Total (n=29) Any related adverse event 9 (56.3) 4 (30.8) 13 (44.8) Fatigue 0 3 (23.1) 3 (10.3) Nausea 1 (6.3) 2 (15.4) 3 (10.3) Diarrhea 2
Slide 30: Voruciclib Summary
Voruciclib Summary Oral CDK9 inhibitor: Pre-clinical data demonstrate down regulation of MCL1 and synergy with venetoclax in multiple hematologic malignancy models Increased MCL1 is clinically established as a venetoclax resistance mechanism Early clinical data demonstrates initial tolerability and
Slide 31: ME-344: Mitochondrial Inhibitor
ME-344: Mitochondrial Inhibitor
Slide 32: Tumor Cell Metabolic Plasticity Provides Escape Route for Continued Growth
Tumor Cell Metabolic Plasticity Provides Escape Route for Continued Growth In vivo, tumor cells display metabolic plasticity switching between glycolysis and mitochondrial metabolism Pre-clinical data demonstrate ability of VEGF inhibitors to modulate tumor’s glycolytic dependence by increasing bloo
Slide 33: Clinical Study Objectives: Bevacizumab and Shift to Mitochondrial Metabolism
Clinical Study Objectives: Assess ability of bevacizumab to shift tumor reliance from glycolysis to mitochondrial metabolism Assess ability of ME-344 + Avastin to inhibit tumor proliferation compared to Avastin + placebo Arm A Arm B Bevacizumab 15 mg/kg day 1 ME-344 10mg/kg days 8, 15, 21 Bevacizuma
Slide 34: ME-344 in Combination with Bevacizumab in Her2-negative Breast Cancer
VEGF inhibition to shift tumor glycolytic reliance towards mitochondrial dependence ME-344, as a mitochondrial inhibitor, observed to induce inhibition of mitochondrial energy production Antiangiogenic resistance is a major challenge in cancer therapeutics ME-344 In Combination with Bevacizumab in H
Slide 35: ME-344 Phase 1b Study Design in Colorectal Cancer
Cohort 1 ME-344 + Bevacizumab 28-day cycle N = 20 (Open expansion cohort if 4-mo PFS of > 20%) Cohort 1 Expansion ME-344 + Bevacizumab 28-day cycle N = 20 Treatment until disease progression or unacceptable toxicity Relapsed/refractory colorectal cancer Patients with progressive disease after failed
Slide 36: ME-344 Summary
ME-344 Summary ME-344 demonstrated potential to prevent anti-angiogenic escape ME-344 demonstrated Ki67 decrease compared to placebo in HER2-negative breast cancer study, indicative of antitumor activity Pharmacodynamics supports on-target effect Normalized tumor vasculature and hypoxia correction c
Slide 37: A Combined Company with Significant Opportunities for Value Creation
A Combined Company with Significant Opportunities for Value Creation Experienced Leadership Team Three differentiated, promising, clinical candidates based on solid science and data Pipeline led by planned eganelisib Phase 2 HNSCC Study* Expected Funding though mid-2025 and clinical data over the ne
Slide 38: MEI Pharma and Infinity Pharmaceuticals Announce Definitive Merger Agreement
February 23, 2023 MEI Pharma and Infinity Pharmaceuticals Announce Definitive Merger Agreement to Advance 3 Promising Clinical Oncology Candidates
Slide 39: & Infinity’
& Infinity’ PHARMACEUTICALS