Moleculin Biotech, Inc. · NASDAQ:MBRX
Moleculin Biotech — ASH 2023
12 slides from Moleculin Biotech's conference presentation, December 2023
Slide 1: December 2023 ASH Presentation
NASDAQ: MBRX NASDAQ: MBRX|| moleculin.com moleculin.com December 2023 ASH Presentation
Slide 2: Disclaimer
Disclaimer All statements contained herein other than statements of historical fact, including statements regarding our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. The words “believe,”
Slide 3: Core Management Belief
Core Management Belief… Anthracyclines represent the most important first line treatments for AML and Advanced STS. Annamycin allows, for the first time ever, a clear majority of patients to benefit from these treatments. 3
Slide 4: Pathway for AML Patients Showing Unmet Need for Annamycin
Pathway for AML Patients Showing Unmet Need for Annamycin 50% + Fit? 50% Daunorubicin Venetoclax Annamycin 7+3 Ven-Aza (+ Ara-C) (+ Azacitidine) (+ Ara-C) (or targeted) 32% 31% (or other) + 36% + 37% Regimen 7+3 Ven-Aza AnnAraC 18% 19% Fit Patients Unfit Elderly Unfit/2nd Line Sub-population (50%) (
Slide 5: Zero Cardiotoxicity
Cardiotoxicity: Traditional Anthracyclines vs. Annamycin Current Anthracyclines Annamycin Risk of Cardiac Event Zero Cardiotoxicity mg/m2 850 100% 600 8.3% Wider therapeutic O OH O window 550 FDA CH2 OH 65% OH Avoids multidrug Limit 450 3.8% resistance O OH O HO O CH3 Better tissue/organ Risk of Hea
Slide 6: Limitation for Current Standards of Care (SOC)
Limitation for Current Standards of Care (SOC) First Line Therapy in AML is Doxorubicin in a 7+3 Combination AML: Ven+Aza CR of 30-40% Elderly and Unfit • Ven+Aza is the SOC for 7+3 unfit patients Complete Response Rate of • CR rate in FDA approval trial was 37% with Venclexta (SOC) in AML those hav
Slide 7: Preclinical Data Driving Annamycin AML Clinical Direction
Preclinical Data Driving Annamycin AML Clinical Direction AML1 Preclinical Study at MD Anderson Survival Benefits of Annamycin and ARA-C Combination in AML1-Turq2 Model Demonstrated 68% Improvement in Overall Survival with Annamycin+Ara-C vs. Annamycin Alone in AML Mice Model 7 1. Blood (2022)
Slide 8: Advancing Annamycin in AML
Advancing Annamycin in AML Phase 1: MB-104 Phase 1/2: MB-105 Phase 1/2: MB-106 MONOTHERAPY MONOTHERAPY COMBINATION THERAPY 100-120 mg/m2 120-240 mg/m2 Annamycin + Cytarabine • N=6 • N = 20 • Recruitment to date = 16 (planned n = 27) or 59% • 17% CRi (at suboptimal dosing) • Median lines of therapy =
Slide 9: Significant Patient Experiences in MB-106 Annamycin + Ara-C
Significant Patient Experiences in MB-106 Annamycin + Ara-C PROVEN DURABLE TOO RECENT FOR DURABILITY Age (Yrs) Relapsed 78 - Relapsed 64 - Refractory 70 – Relapsed 72- Relapsed or Refractory 2 Arm Study (7 mos) Kladrybine/Cytarabine (2 mos) Prior Therapy (Mos) Ven/Aza (3 mos) Kladrybine/LD AraC (7 m
Slide 10: Annamycin: Results from Clinical Trials
Annamycin: Results from 3 Clinical Trials Phase 1: MB- Phase 1/2: MB-105 Phase 1/2: MB-106 MONOTHERAPY COMBINATION THERAPY 104 120-240 mg/m2 Annamycin + Cytarabine • Three trials – 30 subjects to date with data; ~69% relapsed; Low dose BMA Best % Change from Baseline Prior Therapies start to prove n
Slide 11: Advantages of Annamycin Over Traditional Anthracyclines
Advantages of Annamycin Over Traditional Anthracyclines Validation Methods Wider therapeutic LVEF Evaluation window enabling higher doses to be 100% delivered safely ECHO Strain Evaluation by Central Lab Hair loss Non-Cardiotoxic incidence < 1 65%- 92% with Highly Sensitive Cardiac doxorubicin Bioma
Slide 12: Core Management Belief
Core Management Belief… Anthracyclines represent the most important first line treatments for AML and Advanced STS. Annamycin allows, for the first time ever, a clear majority of patients to benefit from these treatments. 12