Moleculin Biotech, Inc. · NASDAQ:MBRX
Moleculin Biotech — Investor Presentation (June 2024)
27 slides from Moleculin Biotech's investor presentation, Jun 18, 2024
Slide 1: Moleculin
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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, “continue,” “anticipate,” “intend,” “expect.” and similar e
Slide 3: Moleculin
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Slide 4: Our Team
Our Team watery. lamp Founder, President, EO.and Chatman watery. lamp ae 20 Se Founder, President, EOand Chacman win 220 BB GS em. eteabethcomak ® {flomnfelnen ClarUS QUE Management Team Board of Directors sandra Siberman, MO, Pho Chit Medial Ofer — New Products i European Chi so01Ks Sp) romana eer
Slide 5: The Annamycin Opportunity in AML
The Annamycin Opportunity in AML oF 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 subjects
Slide 6: Annamycin Attributes
Annamycin Attributes / Avoidscross —\ / resistance with currently prescribed anthracyclines, \\Ara-Cand Venetociax in preclinical models Non-Cardiotoxic 100% lack of cardiotoxicity as \ validated by independent expert (77 i subjects reviewed to date) Patients treated up to 3,000 mg/m? ime max for Do
Slide 7: Annamycin Has Demonstrated Substantially Greater Cardiac Safety
Annamycin Has Demonstrated Substantially Greater | ot 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
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 ~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
Slide 9: Approved Therapies are Successful for <40% of Patients
Approved Therapies are Successful for <40% of the ~20,000 Annual Newly Diagnosed AML Patients Targeted Therapy Regimen 743, Ven-Aza Gene-Targeted Fit Patients Unfit Elderly 55%-65% Sub-population (50%) (50%) Eligible Durable CR% 36%? 37% ~21% AIl AML benefit? 14% 15% 7% Still leaves Limited to J ‘|
Slide 10: Competitive Landscape — CR/CRi Approval Rates
Competitive Landscape — CR/CRi Approval Rates’ 70% 60% Low Bar for Approval = Gitertnib _Esidenib?—Ivosiderib?Olutasidenib? Gemuzumab2! Annarac3—_Annarac? ! (ospata)_(hifa)—(Tibsovo)—(Rezldhia)—(Mylotara). | (AnnavAraC) (AnnaeArac)t (eur3) (wor) (wor) (oH) (033) lastto7thline (2stline | 20) Ne10) mc
Slide 11: >50% of AML Patients are Ineligible for Approved Targeted Therapies
>50% of AML Patients are Ineligible for Approved Targeted Therapies AnnAraC Treats B All-Comers in 2"4 Line Ineligible 53% & Poror_ecuum
Slide 12: 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% Achieve CR I C | | 2.3%
60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% Achieve CR I C 1 | | 2.3% [ 1.7% |. | ia || Pesky — = — i Gilteritinib _Esasidenib —_Ivosidenib_— Olutasidenib Gemtuzumab, = AnnAraC (Xsopata] Idhifa)? (Tibsovo] Rezlidhia| Mylotarg)?) (Anna+AraC)> 1 (FLT3) (IDH2) (IDH1)4 (10H1)4 (CD33) 4 (2" Line) m= CRS m P
Slide 13: Potential Asset Value is Very High
Potential Asset Value is Very High \\ 60.0% 1 50.0 ; t 1% : F 1 90.0% Servier acquired these two I ; An t 40.0% drugs for ~ $2 billion i ; t 1 30.0% i 1 , 1 20.0% t 1 5.8% , ! 10.0% ° 2.3% 1.7%) 2.4% il 1.3% ! ! 1 1 o wa |i. B| i. FL! Gilteritinib Esasidenib Ivosidenib | Olutasidenib Gemtuzumab! Ann
Slide 14: Potential Asset Value
Potential Asset Value Approved Phase 2 Complete 1* Line Ziftomenib | Revumenib N 286 199/174 20 57 v7 cR 37% 19% /25% 35% 18% 24% Re 64% 239%/33% 40% 25% 47% eth AML 50% 50% 15-23% 30%? 24% 30% Revenue! $128M $28 ~$150M $1.5B $28 ~$1.5B ~$1.9B Valuation Exit? N/A Exit Market Market N/A (ator 2015) i
Slide 15: Growing Body of Data
Growing Body of Data Phase 1: MB-104 MONOTHERAPY 100-120 me/m Phase 1/2: MB-105 MONOTHERAPY 120-280 me/n N=7 17%CRi (at suboptimal dosing) Dosing limited by FDA Lifetime ‘Anthracycline Dose (LTMAD) Trial location— US Well-toleratedin the study population Limitedtolowdoses ‘Morphologic leukemia free
Slide 16: MB-106 Trial (EHA 2024, P537)
MB-106 Trial (EHA 2024, P537) e)= L-Annamycin plus cytarabine in AML subjects Phase 1/2 multi-center, open-label dose-escalation study Treatment: L-Annamycin (230 mg/m2, d1-3); cytarabine (2,000 mg/m?, d1-5) 22 subjects were enrolled (ITT population w/20 evaluable) - first-line (N= 4) - second-line
Slide 17: MB-106 (Annamycin + Ara-C; n=20)
MB-106 (Annamycin + Ara-C; n=20) 45 a2 Line of Therapy 1*Line 24 Line Line Combined Subjects Evaluable To Date ao 3 10 13 Subjects Evaluable Not Dosed Per Protocol G e 1 a Median Age- ¥ eclen oe: oars 69 (19-78) 49 (19-69) 71 (53 - 78) 69 (19-78) Complete R oe mca 8 (40%) 2 (67%) 5 (50%) 7 (54%) Com
Slide 18: Durability of Response (DoR)
Durability of Response (DoR) DAYS* 0 100 200 300 400 500 1 2 3 4 5 I= Durability of Response PCR ss 6 MaeR 1 7 > = continuing 7 >» |e E- Prior Lines of Therapy 8 2 8 ro] 9 ic > 2 ~6 Months and Climbing cen pwouecuum
Slide 19: MB-106 Response by Genotype and Mutation
MB-106 Response by Genotype and Mutation Ooft 31 CHRM 89% (n=9) of CRc responses Complex Karyotypes came from subjects with KMT2A, “generally poor prognosis of 2 RUNX1/1T1 cytogenetics and mutations” ‘SF3B1 [303 Annamycin appears to be CD33, “genotype/mutation agnostic” FLTS IDH2 IDHt TPS3 None/Not
Slide 20: 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
Slide 21: 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 Potential NDA Submission Conclude Pivotal Trial In
Slide 22: Annamycin Demonstrates Efficacy in STS Lung Metastases (MB-107)
Annamycin Demonstrates Efficacy in STS Lung Metastases (MB-107) Demonstrated Stable Disease After Two Treatment Cycles All Subjects in Phase 18 Demonstrated Improvement with Dose < 330 mg/m? and Fewer Prior Therapies inary MB-107 Summan 100% 7% 2% 16 7% 0% 3 15 7 23 26 20 13% * 7 2 2a a ai) (ts) say
Slide 23: The Full Annamycin Opportunity
The Full Annamycin Opportunity Potential for Significant Upside _—— 41K 7 60K TNBCLung Pancreatic Liver 13,500 — 67k STS Lurg Metastases eect Endometrial Lung j 20,000 104K Initial Annamycin ‘Acute Myeloid Colorectal Target Indications Leukemia Se Liver paren cone TOTAL INCIDENCE ~33.5K TOTAL INCIDE
Slide 24: All technology licensed from MD Anderson Cancer Center
Ot All technology licensed from MD Anderson, Cancer Center (MDACC) Sy Supports continuing preclinical research on our technology at MDACC close to $1M per year te Supports preclinical research at UTMB Past & current externally funded trials—MD. Anderson Cancer Center; Emory University, Aflac Cancer
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? ~$13.1MmMarket Cap KE ~2.5M Shares Outstanding* ~ — ~30K- 30 Trading Day Daily Volume>
Slide 26: Upcoming Milestones
Upcoming MIlEStOnES, Complete MB-106 Clinical Trial 1H 2024 End of Phase 2 (EOP2) Meeting with FDA 1H 2024 Annamycin Report Outcome of MB-106 End of Phase 2 Meeting 2H 2024 AML Initiate Pivotal Program 1H 2025 Conclude Pivotal Trial H2 2026 Potential NDA Submission 2027 Annamycin __ FinalMB-107 Data
Slide 27: Moleculin
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