Moleculin Biotech, Inc. · NASDAQ:MBRX

Moleculin Biotech — Technical Presentation (May 2024)

40 slides from Moleculin Biotech's technical presentation, May 7, 2024

  1. Slide 1: Virtual AML Clinical Day

    °S °* Virtual AML Clinical Day

  2. Slide 2: Disclaimer

    — All statements contained herein other than statements of historical fact, including statements regarding our future results of operations and financial position, re forward-looking statements. The words “believe,” “may,” “will” “estimate, tend,” “expec,” and similar expressions are intended to ide

  3. Slide 3: Opening and Introductions

    Opening and Introductions Introduction to Annamycin Walter V. Klemp Acute Myeloid Leukemia: The Unmet Need Martin S. Tallman, MD; Michael Andreeff, MD, PhD Annamycin for the Treatment of AML: Data Review Paul Waymack, MD The Annamycin Opportunity in AML Martin S. Tallman, MD; Michael Andreeff, MD, P

  4. Slide 4: Moleculin Management Presenters

    oohi{MOLECULIN ° 98 ) Ce Walter V. Klemp John Paul Waymack, MD Jonathan P. Foster CEO and Chairman Senior Chief Medical Officer Chief Financial Officer . Bowovecvm

  5. Slide 5: Martin S. Tallman, MD

    Martin S. Tallman, MD Internationally Renowned Clinical Investigator Whose Discoveries Have Fueled the Progress of Leukemia-Targeting Therapies Prestigious Career Having Formerly Served as: + Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chief of the Leukemia Service and Pro

  6. Slide 6: Michael Andreeff, MD, PhD

    Michael Andreeff, MD, PhD Professor of Medicine, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center + Professor of Medicine, Department of Stem Cell Transplantation, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center + R

  7. Slide 7: Walter V. Klemp

    Walter V. Klemp CEO and Chairman

  8. Slide 8: os MOLECUL

    4 ae 7 ’ 7¥ a ‘ os MOLECUL , x

  9. Slide 9: The Annamycin Opportunity in AML

    = The Annamycin Opportunity in AML i) Annamycin in combination with Cytarabine (AnnAraC) has potential to fill unmet need in AML; 60% CRc (50% CR) in 2nd line patients reported in latest Phase 1B/2 study (MB-106) AnnAraC has the potential to more than double 2nd line AML CRs All 84 Annamycin subject

  10. Slide 10: MB-106 (Annamycin + Ara-C)

    MB-106 (Annamycin + Ara-C) Proving Potential Efficacy in AML ‘Subjects Evaluable To Date 20 3 10 13 ‘Subjects Evaluable Not 2 e " 7 Dosed Per Protocol Median Age - Years (Range) 69(19-78) 49(19-69) 71 (53-78) 67(19-78) ‘Complete Remission (CR) sy 7 - ee 40% 67% 50% sa% Complete Remission ; ‘Composit

  11. Slide 11: Roadmap to the Paradigm Shift to New Standard of Care in 2nd Line AML

    Roadmap to the Paradigm Shift to New Standard of Carein 2"4 Line AML Pre-2016 2016 an Orug Track Desig mo

  12. Slide 12: Annamycin: A Next-Generation Anthracycline

    Annamycin: A Next-Generation Anthracycline a, Epirubicin Y Doxorubicin, Idarubicin Unique new structure: Result: Incorporates key structural elements of 3 different clinically used anthracyclines, plus The 3-deamination and introduction of iodine at C-2 Elimination of cardiotoxicity Overcomes MDRI r

  13. Slide 13: Annamycin Attributes

    Annamycin Attributes / Avoids cross resistance if; 7 with existing / Novesicant activity anthracyclines, Ara-Cand_ ) (safter to handle and ister) Non-Cardiotoxic Qyeeesme \ “ preclinical models 100% lack of cardiotoxicity as \ / Significantly lower validated by independent expert (77 —<$——<—— incide

  14. Slide 14: Annamycin Has Demonstrated Substantially Greater Cardiac Safety

    Annamycin Has Demonstrated Substantially Greater Cardiac Safety Compared to Approved Anthracyclines Current Anthracyclines sr Risk of Cardiac Event eer e Wider therapeutic L2 window a sooner oH T a Avoids multidrug ry cc 5 | tissue/organ Risk of Heart Failure et aa

  15. Slide 15: FDA Recommended Model Shows Annamycin's Lack of Cardiotoxicity

    FDA Recommended Model Shows Annamycin’s Lack of Cardiotoxicity ‘% of Mice with Heart Lesions The gold standard preclinical Bertozolli model for measuring cardiotoxicity shows Annamycin is effectively non-cardiotoxic when compared with doxorubicin Free Annamycin (API only) is substantially less cardi

  16. Slide 16: Comparison of L-ANN and Dox Efficacy in AML-ETO FLT3-ITD, P53-/- Model

    Comparison of L-ANN and Dox Efficacy in AML-ETO FLT3-ITD, P53-/- Model Experimental Design Female 86 mice were injected IV with 1 x 10°5 AML-ETO FLT3-ITD, P53-/- Model. The treatment started on Day 5 and consisted of six weekly injections of L-ANN or Dox, both administered IV at 4 mg/kg. Survival wa

  17. Slide 17: Survival Benefits of Annamycin and ARA-C Combination

    Survival Benefits of Annamycin and ARA-C Combination in AML-ETO FLT3-ITD, P53-/- Model 3 jo * Mice were implanted IV with 1 x 105 AML-ETO $ tlyient FLT3-ITD, P53-/- cells on day 0. = 1 LANN 4 mg/kg 5 latte’ * Animals were randomized into groups (n = 10 - s 12) and treatment was initiated on day 5. 8

  18. Slide 18: Acute Myeloid Leukemia: The Unmet Need

    Acute Myeloid Leukemia: The Unmet Need Martin S. Tallman,MD Michael Andreeff, MD, PhD

  19. Slide 19: Acute Myeloid Leukemia (AML)

    Acute Myeloid Leukemia (AML) A type of cancer that starts in the blood-forming cells of the bone marrow, leading to the rapid ~160,000 9X0), 000 growth of abnormal white blood cells Cases Newly Diagnosed Worldwide? Annually (U.S.)? Symptoms include fatigue, frequent infections, easy bruising, and bl

  20. Slide 20: AML Patient Journey

    AML Patient Journey = A wero, Succumb ff 60% to Disease H ‘ Significant Unmet Need |

  21. Slide 21: The Unmet Need in AML, Particularly 2nd Line

    The Unmet Need in AML, Particularly 2"4 Line a = ) 2"4 line patients that Side effects limit the Many patients don’t have don’t respond to 1* line ability to use intensive the necessary genetics for therapies treatments in older targeted therapies and patients or those with not all respond even if o

  22. Slide 22: Targeted Therapies Have Limited Benefit to Date

    Targeted Therapies Have Limited Benefit to Date Low Bar For Approval = Ineligible 200% 53%

  23. Slide 23: Annamycin for the Treatment of AML: Data Review

    Annamycin for the | Treatment of AML: Data Review ‘ John Paul Waymack, MD Senior Chief Medical Officer

  24. Slide 24: Annamycin Outperforms

    Annamycin Outperforms | 60% a ' f Durable CRc rate in 2"¢ Line AML patients 50% 0% 60% Full CR rate in ‘ 24 Line AML’ Annamycin’s P1/2 '¥ data exceed every Cardiotoxicity AML drug approval AML population who could benefit from Annamycin

  25. Slide 25: AML Clinical Development Plan

    AML Clinical Development Plan: Rapidly Advancing Towards Pivotal Study Phase 1: MB-104 /2: MB Phase 1/2: MB-106 MONOTHERAPY COMBINATION THERAPY 100-120 mg/m? 2 Annamycin + Cytarabine Completed G ed 4 Ongoing Pivotal Study Upcoming

  26. Slide 26: MB-104 Results

    MB-104 Results Patient population: 7 patients (71% relapsed, 29% refractory) + Median months from diagnosis: 14 * Prior treatments * Chemotherapy: median 3 (range 2-5) * Other: median 1.5 (0-2) Safety: Annamycin was well-tolerated in the study population + Most frequent TEAEs: low platelet count, lo

  27. Slide 27: MB-105 Conclusions

    MB-105 Conclusions C) « Annamycin was well-tolerated in the study population * RP2D was determined to be 240 mg/m? * 80% ORR at RP2D * Pharmacokinetics: analysis ongoing * Based on preliminary clinical results for Annamycin monotherapy, supported by animal data for the combination of Annamycin with

  28. Slide 28: MB-106 Efficacy Summary

    MB-106 Efficacy Summary All-1T pp N 20 18 10 CR 40% 44% 50% Re 45% 50% 60% ORR 55% 61% 70% 28 Notes: Preliminary data from MB-106 56% 67% 78% Notes: ITT = Intent to Treat; PP = dosed Per Protocol. 2 patients who were enrolled on an ITT basis were not treated Per Protocol, one of which had an allergi

  29. Slide 29: Significant Patient Experiences in MB-106 (Annamycin + Ara-C)

    Significant Patient Experiences in MB- 106 (Annamycin + Ara-C) Age 78 64 70 n 64 53 69 49 57 elapsed sti ots be Relapsed Refractory Relapsed —Relapsed —~Relapsed Refractory. «1 Line 1 Line elapsed ; 17432) : 2ArmStudy Cladribine/ : Prior Therapy cides CladtbineND Ven raya) 7#3*Cladrbne ong one Mitox

  30. Slide 30: Durability of Response (DoR)

    Durability of Response (DoR) Days* oO 100 200 300 400 Median Durability to Date= 4.9 Months B= purability of Response > = Continuing EI= Prior Lines of Therapy yoquerpaw 4.9 Months Bpwocecuun

  31. Slide 31: The Annamycin Opportunity

    The Annamycin Opportunity Martin S. Tallman,MD ) Michael Andreeff, / MD,PhD

  32. Slide 32: Growing Body of Data

    Growing Body of Data Phase 1: MB-104 MONOTHERAPY 100-120 mg/m? N=7 . 17%CRi (at suboptimal dosing) + Dosing limited by FDA Lifetime Anthracyctine Dose (LTMAD) Trial location—US i Welltoleratedinthestudy population + Limitedtolowdoses Morphologic leukernia free state was achievedin one subjectin the

  33. Slide 33: Annamycin vs. Current Therapies

    Annamycin vs. Current Therapies J 60.0% 1 90.0%" 5 50.0% f ' i) 1 40.0% q i) 1 1 1 30.0% 1 1 i) q 20.0% i) 1 10.0% oo 2.3% 1.7% 2.4% 13% ! ! i) 1 ex | a wale 4 Li 1 Gilteritinib Enasidenib _vosidenib_Olutasidenib Gemtuzumab | AnnArac ; (%sopata) _(Idhifa)_—(Tibsovo)_—_(Rezlidhia)__(Mylotarg) _ (Anna

  34. Slide 34: Annamycin vs Current and Upcoming Therapies

    Annamycin vs Current and Upcoming Therapies Ven Idhifa/Tibsovo | Ziftomenib | Revumenib N 153 199/174 7 10 CR (38% 37% 19%/25% 35% 18% 24% Ss0% | CRC 48% 64% 239%/33% 40% 25% 47% 60%

  35. Slide 35: How Annamycin Potentially Fits into AML Treatment Paradigm

    How Annamycin Potentially Fits into AML Treatment Paradigm Individualized Treatment Plan +3 | Ve a | Targeted Therapy on /Remis _> Positive Potent < Outcome ! Candidate | Annamycin Opportunity

  36. Slide 36: Driving Towards Pivotal Study and Potential Approval

    Driving Towards Pivotal Study and Potential Approval Walter V. Klemp CEO and Chairman

  37. Slide 37: Path to Potential Approval in 2nd Line AML

    Path to Potential Approval in 2"¢ Line AML Rapidly Advancing Towards Potential Unmet Need, Data Generated to Date Approval While Creating Optionality and Peer Valuation Suggest Potential for Significant Value Creation for Potential Commercialization Potential NDA Submission Conclude Pivotal Trial In

  38. Slide 38: Driving Towards Pivotal Trial: MB-108

    Driving Towards Pivotal Trial: MB-108 Engaging with AML Experts On Track for End of Phase 2 (EOP2) Meeting with FDA Seeking SPA to reduce regulatory approval risk Proposed Pivotal Trial Design? Multicenter study across United States and Europe 2°° Line AML Patients N= 100-150 Primary Endpoint: CRe D

  39. Slide 39: Q&A

  40. Slide 40: The Annamycin Opportunity in AML

    The Annamycin Opportunity in AML anf @& Phase 28/3 Ready strong Data! Baie Value Asset Relatively small (n=100-150), Outperforming every asset Last transaction (2021) was $2 billion quick (12-18 months) clinical trial approved in AML for a lesser asset in same space Seeking SPA to reduce regulatory

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