Moleculin Biotech, Inc. · NASDAQ:MBRX
Moleculin Biotech — Non-Deal Roadshow (September 2018)
25 slides from Moleculin Biotech's roadshow presentation, Sep 19, 2018
Slide 1: Public Information - September 18, 2018
NASDAQ: MBRX Public Information- September 18, 2018
Slide 2: 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 3: Robust pipeline
Robust pipeline 3 distinctly different technologies - six potential drug candidates, all with blockbuster potential World-leading collaboration MD Anderson Cancer Center/Mayo Clinic/Emory University Breakthrough disruptive technologies Annamycin for AML: designed to be non-cardiotoxic, avoids MDR1 W
Slide 4: Experienced Management Team
Experienced Management Team Selected Prior Experience Walter Klemp Chairman, President & CEO Don Picker, PhD Chief Science Officer Jonathan P. Foster. CPA, CGMA EVP & CFO Robert Shepard, MD, FACP Chief Medical Officer Sandra Silberman, MD & PhD Chief Medical Officer – New Products 4
Slide 5: Science Advisory Board
Science Advisory Board Members Selected Prior Experience/Publications Waldemar Priebe, PhD John Paul Waymack, MD, SCD Jorge Cortes, MD Elihu Estey, MD 5
Slide 6: Development Pipeline
Development Pipeline Preclinical Clinical Preparation Phase I/II Collaboration Annamycin AML Annamycin + WP1066 WP1066 - Glioblastoma, melanoma metastasized to the brain WP1066 - Diffuse intrinsic pontine gliomas (children) WP1122 - Glioblastoma Brain Tumors Brain WP1122 + Avastin - Glioblastoma WP1
Slide 7: Development Roadmap
Development Roadmap WP1066 WP1122 Annamycin IND MDA WP1220 Mouse Study Avastin POC IND/Clinic (Clinic; adult Mouse Study (CTCL Poland) (Norway) GBM) (Norway; GBM) (AML) Potential for Mayo CTA/Clinic (grant; pediatric MDA SRA Pancreatic WP1732 (AML; Poland) DIPG) Cancer WP1234 Other Potential for Ins
Slide 8: Value Inflection Points
Value Inflection Points Points we consider to be key development milestones that may influence big pharma’s decision to license or acquire: • Annamycin – generation of Phase I/II data consistent with the clinical trials already completed • WP1066 and WP1122 – Proof of concept (showing activity again
Slide 9: Development Strategy
Development Strategy • Orphan Drug targets with high revenue potential • Focus on game-changing breakthroughs • Collaborate closely with MD Anderson Cancer Center • Minimize cash burn through virtual structure • Worldwide exclusive licenses and regulatory exclusivity create proprietary positioning f
Slide 10: Industry Opportunity
Industry Opportunity • Orphan Drug sales represented approximately $29 billion in revenue in 2013 • There are no approved second-line therapies for AML • CPXX sold for $1.5 billion based on improving OS by 3.5 months, yet still leaves most AML patients without hope • Similar opportunities exist in b
Slide 11: Technologies developed at MD Anderson Cancer Center
Most of our technologies were developed at MD Anderson Cancer Center, the world’s largest cancer research facility centered within the world’s largest medical center With over 1,500 cancer researchers, our sponsored research has been supported by truly state of the art resources 11
Slide 12: Delivering Solutions
myc o ma Delivering Solutions
Slide 13: Annamycin Critical Advantages over Leading Drugs
Annamycin Critical Leading drugs are cardiotoxic and lose efficacy due to multidrug Advantages resistance over Leading Annamycin has little to no cardiotoxicity, avoids multidrug Annamycin Process Drug resistance, has been shown to be more potent in AML cell lines and has shown activity in patients
Slide 14: Annamycin Delivers Remarkable Performance in Relapsed/Refractory Leukemia
Annamycin Delivers Relapsed/Refractory Acute Leukemia Patients Remarkable In a proof-of-concept Phase I/II clinical trial, 63% Performance Annamycin was given to patients who had failed an average of five previous induction Efficacy therapy attempts Signal 37% of those patients cleared enough of the
Slide 15: Annamycin could qualify more people for induction therapy
Annamycin has the potential to qualify more people for induction therapy Leukemia is a cancer of the white blood cells Induction Therapy BMT and the acute forms of leukemia can manifest quickly and leave patients with limited (Qualify for BMT) (Results in treatment options Cure) The only viable opti
Slide 16: WP1066 Portfolio Overview
WP1066 Portfolio Overview Based On Natural Built from chemical backbone of bee pollen WP1066 Process Compound compound Unique Dual Action First drug to both directly inhibit tumor signaling while also stimulating patient immune response Activity Against Pre-clinical testing shows high level of activ
Slide 17: Proposed MOA of WP1066
Proposed MOA of WP1066: Deubiquitinase-Mediated Control of p-STAT3 Aberrant deubiquitination can lead to constitutive WP1066 activation of STAT3 p-STAT3, an blockade activated form WP1066 blocking of DUBs of STAT3 shifts the equilibrium Ubiquitinatedtowards ubiquitinated p-STAT3 STAT3 Activated STAT
Slide 18: WP1122 Portfolio Overview
WP1122 Portfolio Overview Addicted to A brain tumor requires as much as 18 to 37 times as Tumors are hyper-consumers of glucose Sugar much glucose to survive as a healthy brain cell and starve to death without it Starving a Tumor This eventually led to the theory that, if we feed tumor to Death cell
Slide 19: WP1122 is Effective In Vivo against Gliomas
WP1122 is Effective In Vivo against Gliomas - July 2017 Control Temodar WP1122 10 8 6 4 # of Animals 2 Orthotopic 0 Glioblastoma 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 Days Model in Mice WP1122 used alone has at least the same or greater activity than temozolomide (Temodar®), a current standar
Slide 20: WP1122 Shows In Vivo Activity Against Pancreatic Cancer
WP1122 Shows In Vivo Activity Against Pancreatic Cancer - January 2018 Treatment period Days after first administration 20
Slide 21: Recent Developments Since June 2018
Recent Developments Since June 2018 • WP1066 Begins Patient Dosing at Clinical Trial Being Conducted at MD Anderson • Seeks Approval from Polish Regulatory Agency for Skin Cancer Clinical (WP1220 - WP1066 Portfolio) Trial • Enrollment Opens for Brain Tumor Trial of WP1066 • Expects to Meet FDA IND F
Slide 22: Milestones
Milestones Anticipated Milestone Potential Timeframe Announcement that our Investigational New Drug (IND) for Annamycin has become effective and that we Accomplished may begin clinical trials Initial IRB (Institutional Review Board) approvals and site initiations of various clinical sites participat
Slide 23: Financial Overview
Financial Overview 23
Slide 24: Financial Statement Summary
Financial Statement Summary In thousands - except for loss per share and shares outstanding For the Six Months For the Year Ended Ended 6/30/18 12/31/17 (Unaudited) (Audited) Statement of Operations Data Revenue $ - $ - Research and development 5,469 4,545 General and administrative 2,626 4,108 Tota
Slide 25: Robust pipeline
Robust pipeline 3 distinctly different technologies - six potential drug candidates, all with blockbuster potential World-leading collaboration MD Anderson Cancer Center/Mayo Clinic/Emory University Breakthrough disruptive technologies Annamycin for AML: designed to be non-cardiotoxic, avoids MDR1 W
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