Moleculin Biotech, Inc. · NASDAQ:MBRX
Moleculin Biotech — Q3 2024 Earnings Presentation
33 slides from Moleculin Biotech's earnings presentation, Nov 12, 2024
Slide 1: Moleculin Q3 2024 Conference Call Presentation
Slide 2: Disclaimer
Disclaimer All statements contained herein other than statements of historical fact, including statements regarding our future results of operations an financial position, ‘our business strategy and plans, and our objectives for future operations, are forward-looking statements. The words “belive,”
Slide 3: Current Market Cap Creates Opportunity
- MOLECULIN | - Current Market Cap Creates Opportunity aN emm * Investors focused on targeted therapies, yet Venetoclax (a Anthracyclines Used In: chemotherapy) created far more value over last 5 years i pranse cancarss 32%. * For 50+ years anthracyclines have remained the bedrock treatment for many
Slide 4: Annamycin Attributes
Annamycin Attributes No vesicant activity Developed in (safer to handle and ‘collaboration with oe administer) and licensed from Composition é MD Anderson: of Matter fac” Avoids Cross ey eae Non- ae) Resistance ee Cardiotoxic wth curently prescribed Cemphalylts ) preclinical models \. ax for Dox NCE
Slide 5: Approved Therapies are Successful for Only ~40% of AML Patients
Approved Therapies are Successful for Only ~40% of AML Patients? Daunor Venetoclax Targeted Therapy Regimen 743, Ven-Aza Gene-Targeted FitPatients UnfitElderly §5%-65% Sub-population (60%) (50%) Eligible Durable CR% [iS6%2 37% ~21% AIAML benefit? 14% 15% 7% Criticar Catdiotox; de —Stillleaves Limite
Slide 6: MB-106 (Annamycin + Ara-C (AnnAraC); n=22)
MB-106 (Annamycin + Ara-C (AnnAraC); n=22) Subjects Evaiuable To 1 ashi 22 4 1 10 H 14 Subjects Evaluable Not 1 ‘Dosed Per Protocol 2 ° ‘ 1 4 i bela gaat 67.5 (19-78) 56.5 (19-69) ' 71 (53 - 78) 4 62.5 62-78) srission 1 Cleon Bir asad 8 (36%) 2(60%) t 560%) 1 6 (43%) 1 Complete Remission spell 9 (41
Slide 7: Durability, MRD, Prior Therapies
Durability, MRD, Prior Therapies Bao} £ Therapy MRD 78% MRD negative 50% of CRs bridged to BMT urabilty of Remission continuing f= Prior Lines of Therapy @ ssurject relapsed, ikely due to cessation of treatment due to infection, Continues with F/U @ subject died from infection/PO © Progressive disea
Slide 8: Adaptive Trial Design MIRACLE
Adaptive Trial Design MIRACLE Moleculin R/R AML AnnAraC Clinical Evaluation Annamycin 2 (one unblinded) 190 mg/m + Data Readouts HIDAC es Annamycin Optimurr 230 me/m? + HIDAC *Criteria: (003 Efficacy mize 1: Control Arm Safety + placeb Tolerability Control Arm HIDAC + lacebo eR Doses and adaptive de
Slide 9: FDA provided clear written guidance on 190 mg/m² vs. 230 mg/m²
FDA provided clear written guidance by recommending the comparison of 190 mg/m? vs. 230 mg/m? Project Optimus fiisrSifcenetewwens0und 20 Guidance Initial PK analysis shows no correlation between AUC OF Cinae and change in dosage from 190 to 230 Corroborates clinical findings Could reduce potential f
Slide 10: Estimated Regulatory Timeline
Estimated Regulatory Timeline 2024 2025 2026 2027 2028 | 2029
Slide 11: The Bar for Approval is Low
The Bar for Approval is Low Complete Remission (CR) 50% HIDAC CR rates are well documented Annamycin NDA to be based on CR rate in 2"¢ line subjects at ~1 aE month Hoact woac? Aanarac3 Aenanc3 ——Anndrac? Mires Tral Clase Tal AkComers = «2ndeSrdUne Ondine 1~Mitros Trial, 81% 2° ine patients; 17% CR,
Slide 12: Potential Accelerated Regulatory Timeline
Potential Accelerated Regulatory Timeline Breakthrough Designation Peworecuum
Slide 13: Site Selection is Moving Quickly
60 sites interested 17 more sites targeted Site Selection is Moving Quickly 12sites
Slide 14: The Full Annamycin Opportunity
The Full Annamycin Opportunity? Potential for Significant Upside — 60K Pancreatic ver 13,500 PFS and OS rivaling om Stem 1° line in 4-5" line cre STS subjects? Endometrial Lung a 20,000 — 104K Initial Annamycin ‘aie ast Colorectal Target Indications Leukemia craccap eas Liver TOTAL INCIDENCE ~33.5K
Slide 15: Financials
Financials Nasdaq: MBRX ~$9.4M Cash Balance? ~$17.3M Market Cap? 3.0M O/S and 6.1M Shares Fully Diluted Outstanding* ~32K — 65-day Avg. Daily Trading Vol.>
Slide 16: Estimated Regulatory Timeline
Estimated Regulatory Timeline 2024 2025 2026 2027 2028 | 2029
Slide 17: MIRACLE
MIRACLE , 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 the first quarter of 2025
Slide 18: Q&A Session
)LECULIN . 4 (Q&A Session
Slide 19: Appendix
Appendix
Slide 20: 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 500% | ; H 1 ; 1
60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 4 1 1 500% | ; 1 H 1 ; 1 i ' f 1 A 1 H 1 i ' 1 1 1 5a 2.3% 1.7% 2.4% 13%} 1 1 = = = -= —! 1 1 GilteritinbEnasidenib —_IvosidenibOlutasidenib. Gemtuzumab, AnnArac _1 (Xsopata) (Idhifa)?—(Tibsovo)_—_(Rezlidhia)__(Mylotarg)? (Anna+Arac)? 1 (FLT3) (I10H2) (1oH1)*
Slide 21: Potential Asset Value
Potential Asset Value ( ‘Approved Phase 2 Complete 1 Line Idhita/ N 153 286 199/174 20 57 7 10 CR 38% 37% 19% /25% 35% 18% 20% 50% | CR 48% 64% 2396/33% 40% 25% 47% 60% Ws 50% 50% 15-23% 30%? 24962 30%? Revenue? $128M $28 ~$150M $1.58 $28 Valuation Exit? N/A Exit? (equston of eguston of er, 2016) ‘s
Slide 22: Soft Tissue Sarcoma Mets to the Lungs
Soft Tissue Sarcoma Mets to the Lungs “We don’t expect to see these kinds of responses in STS patients with lung metastases who have stopped responding to 1* line therapy...let alone in 4" line!” STS KOL 025 * Preliminary results, subject to final clinical study report which is expected to be issued
Slide 23: Annamycin: A Next-Generation Anthracycline
Annamycin: A Next-Generation Anthracycline LL dan a ee AS il ‘Annamycin a Coe = . © et, mt Epirubicin Idarubicin mm Doxorubicin
Slide 24: Annamycin Has Demonstrated Substantially Greater Cardiac Safety
Annamycin Has Demonstrated Substantially Greater Cardiac Safety Compared to Approved Anthracyclines Current Anthracyclines Annamycin Zero Cardiotoxicity
Slide 25: 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 c measuring cardiotoxicity shows Annamycin is effectively " non-cardiotoxic when compared with doxorubicin. Free Annamycin (API only) is substantially less c
Slide 26: Annamycin Shown Effective Against Cytarabine and Venetoclax Resistant Cell Lines
Annamycin Shown Effective Against both Cytarabine and Venetoclax Resistant Cell Lines MOLM-13 MOLM-13 Cytarabine resistant Venetoclax resistant mi nitivisss: ee oof EE, ee x 1 y ¥ bh vk tan VIX, 1000 m8 uy mS & * oa 0. ——= 7 0. ——s a a a ere concentrations, alt concentrations, alt
Slide 27: Annamycin Synergizes with ARA-C in p53-null, FLT3 mutated AML Model
Bone marrow Spleen Lungs Annamycin Synergizes with ARA-C in Increasing Survival in p53-null, FLT3 mutated AML Model (AML-mTurqoise2) Analysis of Minimal Residual ase (MRD) ANN LANN+ ARA-C 100: a Day 36 Day 36 a CS © Vehicle 50: = LANN 4 maka, “= ARA-C 50 mgikg ~ LANN + ARA-C Percent survival 0 10 20
Slide 28: AML Clinical History
AML Clinical History Phase 1/2: MB-106. oN + N=20 ‘+ N=22alllines (0-6), N= 10 2" line) + 17% CRi (at suboptimal dosing) + Median fines of prior therapy = 4 1+ All subjects (N22) 41% CRe (177) + Dosing limited by FDA tifetime + Median age of 240 me/r?(RPD2) + 2nd tine N=10, 60% CRe ‘auhracycline Dos
Slide 29: MB-106 Response by Genotype and Mutation
MB-106 Response by Genotype and Mutation Q31 CHRM Complex Karyotypes 89% (n=9) of CRc responses anes peed came from subjects with arenas “generally poor prognosis a cytogenetics and mutations” Es Annamycin appears to be os “genotype/mutation agnostic” Pers: He DH P53 NoneiNot tested Note —n=20; Some
Slide 30: Annamycin Demonstrates Efficacy in STS Lung Metastases (MB-107)
Annamycin Demonstrates Efficacy in STS Lung Metastases (MB-107) - As Reported in Feb 2024 Demonstrated Stable Disease After Demonstrated Improvement with Dose < 330 mg/m? ‘Two Treatment Cycles and Fewer Prior Therapies All Subjects Preliminary MB-107 Summary Ry sua ae ateay) aga 20) 208) ae 307) [sa
Slide 31: Science Advisors
Science Advisors Waldemar Priebe, PhD MD Anderson Cancer Center Dr. Daniel Von Hoff Mayo Clinic Founding Scientist & SAB Chair = Hematology Oncology —— Dr. Martin Tallman Dr. Jorge Cortes Northwestern University Augusta University Dr. Michael Andreef Dr, Giovanni Martinelli MD Anderson Cancer Center
Slide 32: 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
Slide 33: Upcoming Milestones
Upcoming Milestones \ = Begin contracting with MIRACLE trial sites 2H 2024 First subject treated in MIRACLE trial 1Q,2025 Data Readout (n=45) (safety and overall efficacy review) 2H 2025 Annamycin __ Data Readout (n=~90) unblinded and Optimum Dose set for MIRACLE trial 242006 AML Begin enrollment of