Moleculin Biotech, Inc. · NASDAQ:MBRX
Moleculin Biotech — Investor Presentation (August 2024)
27 slides from Moleculin Biotech's investor presentation, Aug 1, 2024
Slide 1: ay ditonsouum
ay ditonsouum
Slide 2: Disclaimer
Disclaimer Al 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 Beliefs on Annamycin Position
Core Management Beliefs on Annamycin Position Safer and more effective than currently prescribed anthracyclines Non-cardiotoxic and avoids cross res Venetoclax Fills an unmet need for more than half of AML patients Delivers more than double the CR rate of any approved treatment forr/r AML Potential
Slide 4: Our Team
Our Team v.Klemp Founder, President, CEOand Chairman Walter V, Kiemp soln Zeno BS faa Founder, Presigent, CEO and Chairman soln ZENO BR AE rm Michael 0. Cannon Jonathan P. Foster cutive VP & Chief Financial Officer ex Fl er! petoitte Paul Waymack Senior Chief Madical Officer ia Management Team Board
Slide 5: The Annamycin Opportunity in AML
The Annamycin Opportunity in AML ( 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 Complete Remissions All 84 Anna
Slide 6: Annamycin Attributes
Annamycin Attributes } No vesicant activity \, (safertohandle and) administer) jf / Composition ‘of Matter - Patents thru Avoids Cross incidence (10%) of Non- Wed Resistance (Indence 108) of Cardiotoxic iiennet geste Cane ificantly lower 100%) / - " - s, Ara-C and \ / Zero cardiotoxicity per indepen
Slide 7: Annamycin Has Demonstrated Substantially Greater Cardiac Safety Compared to Approved Anthracyclines
Annamycin Has Demonstrated Substantially Greater Cardiac Safety Compared to Approved Anthracyclines Current Anthracyclines Annamycin Sse Zero a Cardiotoxicity — ween 2 on I window ephodeeticDecrg | Iq son Limit = ie i t Avoids multidrug ») ] Risk of Heart Failure Bworecuum
Slide 8: 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 growth of abnormal white blood cells Symptoms include fatigue, frequent infections, easy bruising, and bleeding ~160,000 ~20,000 Cases Newly Diagnosed Worldwide? Annual
Slide 9: Approved Therapies are Successful for Only ~40% of AML Patients
Approved Therapies are Successful for Only *40% of AML Patients? Daunorubicin} Venetoclax Targeted (+ Azacitidine) Therapy Regimen 7+#3 2 ~~ Ven-Aza "Gene-Targeted 7 . Fit Patients Unfit Elderly 55%-65% Sub: population (50%) (50%) Eligible Durable CR% 36%? 37% ~21% AIl AML benefit? 14% 15% T% Critic
Slide 10: >50% of AML Patients are Ineligible for Approved Targeted Therapies
>50% of AML Patients are Ineligible for Approved Targeted Therapies AnnAraC Treats X \ All-Comers in 2" Line Ineligible 53% Bworecuun
Slide 11: ~13% of 2L AML Patients Expected to Achieve CR
60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 1 1 z 50.0% ! ~13% of 2LAML Patients Expected to : a) Achieve CR I : I : 1 f i} " 1 : 1 i 1 i 1 1 5.8% | 2.3% 1.7% 2.4% 73% : 1 1 |_| = — = _ ! I 1 Gilteritinib Esasidenib —_Ivosidenib_Olutasidenib Gemtuzumab, AnnAraC | (Xsopata) (Idhifa)? (Tibsovo)_—(Rezlidh
Slide 12: Potential Asset Value is Very High
Potential Asset Value is Very High 80.0% 1 500% } 1 50.0% ! 80.0% Servier acquired these two I ‘ ines 1 40.0% drugs for ~ $2 billion i { \ 1 30.0% i f ' 1 20.0% 1 ; % j ! 10.0% 58% : : 2.4% 1.3% ; 1 1 ioe | o | q Gilteritinib | Esasidenib _Ivosidenib | Olutasidenib Gemtuzumab! AnnAraC 1 (Xsopata) |
Slide 13: Potential Asset Value
2 Potential Asset Value b So 60% Approved nase 2 Complete 2°4 Line Servier Kurat Syndaxt | ishifa/tibsove | Ziftomenib- N 153 286 199/174 20 57 17 CR 38% 37% 19%/25% 35% 18% 24% CRe 48% 64% 23%/33% 40% 25% 47% Paouon 50% 50% 15-23% 30%? 24% 30%? Revenue? $128M $2B ~$150M $1.5B $28 ~$1.5B ~$1.9B Valu
Slide 14: AML Clinical History
AML Clinical History “ Phase 1: MB-104 MONOTHER Phase 1/2: MB-105 MONOTHERAPY 0-240 mg/m Phase 1/2: MB-106 COMBINATION THERAPY N=7 17% CRi (at suboptimal dosing) Dosing limited by FDA Lifetime Anthracycline Dose (LTMAD) Trial location—US Well-toleratedin the study population Limitedtolowdoses Morpho
Slide 15: MB-106 (Annamycin + Ara-C (AnnAraC); n=22)
MB-106 (Annamycin + Ara-C (AnnAraC); n=22) &3% All Lines (15-7 g All Lines ) Combined Lin Subjects Evaluable To I Dabs 22 4 H 10 4 14 Subjects Evaluable Not 2 0 1 1 I 1 Dosed Per Protocol I 1 1 Median Age - Y« aml gta 67.5 (19-78) 56.5 (19-69) ! 71 (53 - 78) } 69.5 (53-78) Crochhgeme! eee 8 (36%) 2
Slide 16: Durability, MRD, Prior Therapies
Durability, MRD, Prior Therapies Prior Days 100 200 300 400 500 § Therapy) >, =} > Ene > 1 |e 1 3 Es o \ hed : > ! 5 o aT montnermecan ie durability and climbing ‘ 6 TT > i |e ’ > 78% MRD nega 1 @ |e on ! ’ Ze | |e 1 ! ° > [= durability of Remission D> = continuing rior Lines of Therapy H © §) 2 ! i
Slide 17: MB-106 Response by Genotype and Mutation
MB-106 Response by Genotype and Mutation Q31CHRM ComplexkKaryotypes seGec KAT24 came from subjects with RUNX1/1T1 Ai 4 generally poor prognosis SF3B1 7 cytogenetics and mutations’ ER cx Annamycin appears to be 89% (n=9) of CRc responses “genotype/mutation agnostic” None/Not tested 2 3 4 Note ~ n=20;
Slide 18: MIRACLE
(MRACLE Moleculin R/R AML AnnAraC Clinical Evaluation Phase 3 pivotal clinical trial designed to seek accelerated new drug approval for Annamycin in the treatment of relapsed or refractory acute myeloid leukemia. Targeted to begin recruiting in 1Q2025.
Slide 19: MIRACLE Adaptive Trial Design Based on EoP1B/2 Guidance
MIRACLE Adaptive Trial Design Based on EoP1B/2 Guidance * Adaptive 3 arm randomized, double-blind Phase 3 pivotal trial comparing AnnAraC at two different doses to placebo, each in combination with High Dose Ara-C (HiDAC) * n=75 randomized 1:1:1 between 190 mg/m2, 230 mg/m2 and placebo * FDA review
Slide 20: Planned MIRACLE2 Follow-On Clinical Trial
Planned MIRACLE2 Follow-On Clinical Trial * n=200 randomized between optimum dose established in initial MIRACLE trial and placebo, each in combination with HiDAC * Same trial design as used with final 120 subjects in initial MIRACLE trial except enrolling 3" line patients instead of 2" line patient
Slide 21: The Bar for Approval is Low
The Bar for Approval is Low Complete Remission (CR) 60% 5056 HIDAC CR rates ag are well MIRACLE trial is documented targeting 2" line 50% subjects; we MIRACLE2 is targeting 3 se subjects 0% Hipact HiDAC 2 AnnArac3 AnnAraC 3 AnnArac 3 Mirros Trial Classic Trial slkcomers 2nd + 3rd Line 2nd Line 4 —Mi
Slide 22: Path to Potential Approval in 2nd Line AML
Path to Potential Approval in 2nd 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 Phase 3 Site Initiation Potential NDA Submission E
Slide 23: The Full Annamycin Opportunity
The Full Annamycin Opportunity Potential for Significant Upside TNBC re é Pancreatic Liver _—— 67K RCC Lung _-= 13,500 STS Lung Metastases cnc Endometrial Lung - —— 20,000 — 104K Initial Annamycin Aesite bared Colorectal Target Indications Leukemia Bosseatl Aves) Liver Expansion Indications \ TOTAL
Slide 24: Global Network
Global Network All technology licensed from MD Anderson Cancer Center (MDACC) Supports continuing preclinical research on our technology at MDACC close to $1M per year Active contractors in US, EU and Asia for drug production and distribution as well as for clinical trial management Past & current e
Slide 25: Cash to Fund Operations into the Fourth Quarter of 2024
Cash to Fund Operations into the Fourth Quarter ~ of 20241 Nasdaq: MBRX ~$17M Cash Balance? 2 ~$13.1M Market Cap: ~2.5M Shares Outstanding w= ~30K - 30 Trading Day Daily Volume®
Slide 26: Annamycin milestones
Annamycin AML Annamycin STS Lung Mets Begin contracting with MIRACLE trial sites First subject treated in MIRACLE trial Interim data (n=75) unblinded and Optimum Dose set for MIRACLE trial Begin enrollment of 3line subjects in MIRACLE2 Enrollment ends for 2"4line subjects Final data for 2"4 ine subj
Slide 27: Core Management Beliefs on Annamycin Position
Core Management Beliefs on Annamycin Position Safer and more effective than currently prescribed anthracyclines Non-cardiotoxic and avoids cross res Venetoclax nce with dox, Ara-Cand Fills an unmet need for more than half of AML patients Delivers more than double the CR rate of any approved treatmen
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