Moleculin Biotech, Inc. · NASDAQ:MBRX
Moleculin Biotech — FY2024 Earnings Presentation
19 slides from Moleculin Biotech's earnings presentation, Mar 24, 2025
Slide 1: Q4 / Year End 2024 Financial Results and Pipeline Update
Slide 2: End of P1B/2 Meeting with FDA Establishes Pathway to Approval
End of P1B/2 Meeting with FDA Establishes Pathway to Approval 3 Arm w/ CR= AnnAraC 2 Early Data Primary SoC Post R/R v. HiIDACt Readouts Endpoint Either Arm Standard of Care available to all R/R subjects post initial treatment Compare Annamycin + HIDAC (AnnAraC) v. HIDAC alone Adaptive trial design
Slide 3: MIRACLE Phase 3 Pivotal Clinical Trial
MIRACLES 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 4: Adaptive Trial Design MIRACLE
Adaptive Trial Design MIRACLE Moleculin R/R AML AnnAraC Clinical Evaluation Annamycin 190 ma/m? + Annamycin Optimum Annamycin mg/m + HDAC *Criteria: (7-30) Efficacy sndomi Control Arm Safety HIDAC + placebo Tolerability Control Arm HIDAC + eb Piece BEE (Doses and adaptive design recommended by FDAin
Slide 5: Potential Accelerated Timeline
Potential Accelerated Timeline Data Readout @n=45 23 Nee: NO4robing process lant depandert por lee offing of OC anesuppertng ND data tors fart A meets high end of expectati may be able to shorten Part B to single arm safety/DEI only Drug approval process could start as early as 2026
Slide 6: Sites selected to date
25 sites selected to date Total ~70 sites targeted @ Interested/Visited @ Interested © Additional Targeted Updated: 3/20/25 Site Selection is Moving Quickly Targeted Sites MIRACLE 10 sites 25 sites Consistent feedback from face-to-face meetings with cover 30 potential investigators: “Annamycin is de
Slide 7: Jonathan P. Foster
Jonathan P. Foster Executive VP & Chief Financial Officer
Slide 8: Financials
Financials Nasdaq: MBRX ~Runway into the 3 Qtr. 2025 with $13.6M Cash Balance? ~$16.2M Market Cap? & a 6 14.0M Shares 0/S* ~ ~1.4M — Daily Trading Vol.> ‘Mgt has reduced overhead, pushed CMC projects into 2026, and engaged with institutions for IT programs for preclinical and clinical activity for n
Slide 9: Upcoming Milestones
Upcoming Milestones ! in AN Impact of data readout Begin enrollment of 3 fine (045) on regulatory subjects in MIRACLE2 Begin contracting pathways Recruitment | with MIRACLE Lscialeotniie Update Enrollment ends for 28 lal sias posters/presentations T plete | | I mize — 1025 = aioas —— 2205 an2006 200
Slide 10: Opportunity for Market Cap Breakout
Opportunity for Market Cap Breakout Annamycin: Disruptive Technology — Unique, patented, non-cardiotoxic and overcomes multidrug resistance; addresses huge unmet need; other potential cancer targets; potential for multiple cycles Annamycin: Clinically Advanced — Phase 2 efficacy significantly better
Slide 11: Corporate Presentation
Slide 12: 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 13: Walter V. Klemp
Walter V. Klemp Founder, President, CEO and Chairman
Slide 14: Recent Developments
Recent Developments Y Preparing to launch MIRACLE Phase 3 Pivotal Trial for Annamycin in combination with cytarabine (AnnAraC) for the treatment of R/R/ AML v v v v v 1 site activated in Europe with multiple subjects in screening; Egypt & Georgia ethics approval received with regulatory expected Q2
Slide 15: AML Key Opinion Leaders' Support for Annamycin
AML Key Opinion Leaders’ Support for Annamycin “The preliminary clinical activity of Annamycin in heavily pretreated, relapsed/refractory AML patients who had progressive disease following Ara-C and VEN is very exciting and would provide a much-needed treatment option for other patients who otherwis
Slide 16: AML Key Opinion Leaders' Support for Annamycin
AML Key Opinion Leaders’ Support for Annamycin “The latest preliminary AML data suggest that Annamycin could result in a promising new the treatment for AML. | am excited to work alongside the Moleculin team to continue advancing its development and further explore its potential to address these are
Slide 17: Dr. John Paul Waymack, Senior Chief Medical Officer
Slide 18: MB-106: Durability, MRD, Prior Therapies - CR/CRi
MB-106: Durability, MRD, Prior Therapies - CR/CRi ~9 mos+ median durability / ~11 mos median OS+ for GRe’s 78% MRD negative 50% of CRs bridged to BMT PD =continuing = Prior Lines of Therapy _....._ Be @ subject relapsed - Continues with F/U @ Subject died from infection/PD
Slide 19: AnnAraC Demonstrated Superior Complete Remission Rate Compared to Current Standard of Care
AnnAraC Demonstrated Superior Complete Remission (CR) Rate Compared to Current Standard of Care Complete Remission (CR) HIDAC CR rates are well a documented Annamycin NDA to be based on CR rate in 2" line subjects at ~1. month woac? woac? Mirros Tal Clase Til