Molecular Insight Pharmaceuticals Inc
Molecular Insight Pharmaceuticals — Investor Presentation (December 2009)
58 slides from Molecular Insight Pharmaceuticals's investor presentation, Dec 3, 2009
Slide 1: Convertible Preferred Offering Investor Presentation
Exhibit 99.1 Molecular Insight Pharmaceuticals, Inc. Convertible Preferred Offering Investor Presentation December 3, 2009
Slide 2: Disclaimer and Safe Harbor
Disclaimer and Safe Harbor Disclaimer This document is based on information provided by Molecular Insight Pharmaceuticals, Inc. (the “Company”) and other sources that the Company believes are reliable and includes additional and updated disclosure where available. CRT Investment Banking LLC, as Plac
Slide 3: Company Overview
Company Overview Publicly traded, clinical-stage biopharmaceutical company (NasdaqGM: MIPI) Portfolio of five clinical stage drugs, all with significant potential product value Focused on the discovery and development of targeted therapeutic radiopharmaceuticals and molecular imaging agents for use
Slide 4: Investment Highlights
Investment Highlights Pioneer in the emerging field of molecular medicine Five clinical-stage candidates addressing seven indications with significant unmet patient needs with no visible potentially competing products in development Significant near-term partnering opportunities in oncology and card
Slide 5: Investment Highlights (continued)
Investment Highlights (continued) Commitment of Cerberus and other existing investors to participate in current fund raise provides validation of products and strategy Business development opportunities are anticipated to supply a significant portion of the needed cash for further advancement of the
Slide 6: Broad and Diverse Pipeline
Broad and Diverse Pipeline Product Current Phase Indication Status Candidate Pre PI PII PIII Azedra™ Treatment of neuroendocrine • Molecule commercialized outside the US Pheochromocytoma tumors using tumor’s • Pivotal trial – Phase II norepinephrine uptake Neuroblastoma • Orphan Drug status mechanis
Slide 7: Clinical Development Timeline
Clinical Development Timeline 2009 2010 2011 2012 2013 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 Azedra Submit NDA NDA Approval IBN201 Pivotal Phase II Trial Neuro Phase III Confirmatory Trial Azedra Submit NDA NDA Approval IB12b Pivotal Phase II Trial Pheo Phase III Confirmatory Trial Phase I Clinical and Trof
Slide 8: Proven Management Team
Proven Management Team Executive Experience Daniel Peters Chairman of the Board of Phidias AB and also serves on the board of MDRNA, Inc. President and CEO Previously served as President and CEO of Medical Diagnostics for GE Healthcare Successfully integrated Amersham Health into GE Healthcare Forme
Slide 9: Board of Directors
Board of Directors Board Member Experience Joseph M. Limber Current President and Chief Executive Officer of Prometheus Laboratories Chairman of the Board John W. Babich, PhD Executive Vice President, Chief Scientific Officer and President of Research David R. Epstein President and Chief Executive O
Slide 10: Scientific Advisory Board
Scientific Advisory Board Board Member Experience William C. Eckelman, PhD Former Chief of Positron Emission Tomography (PET) Department, National Chairman Institutes of Health (NIH) Ronald Van Heertum, MD Professor of Radiology, Acting Chairman of Radiology, Director of the Division of Nuclear Medi
Slide 11: MIPI's Transformational Molecular Imaging Products
MIPI’s Transformational Molecular Imaging Products Trofex, Zemiva & 99mTc-Octreotide Enables early detection, appropriate staging and monitoring of disease Low radiation dose Sensitivity to detect disease when anatomy is still normal Specificity allows disease to be characterized and identified Whol
Slide 12: A New Generation of Targeted Oncology Therapeutics
A New Generation of Targeted Oncology Therapeutics Azedra, Onalta, Solazed & 131I-MIP-1375 Specific targeting delivery of systemic radiotherapy – spares normal tissue Potentially effective anti-cancer treatment Minimal side effects compared to chemotherapy Potential to improve safety and efficacy of
Slide 13: Business Strategy
Business Strategy Establish a market leading oncology-focused specialty pharmaceutical company committed to the discovery, development and commercialization of both targeted radio-therapeutic compounds and targeted molecular imaging radiopharmaceuticals Primary areas of focus include neuroendocrine
Slide 14: Leadership in Oncologic Radiopharmaceuticals
Leadership in Oncologic Radiopharmaceuticals Targeted radiotherapy is an increasingly important contributor in cancer treatment Rational care Proven means to effect tumor remission Logical option in delivering treatment efficacy Imaging is critical in the diagnosis and management of most cancer; it
Slide 15: Enhanced Imaging Technology
Enhanced Imaging Technology Enhanced imaging, directed at clinically relevant targets, will increasingly impact cancer treatment selection and monitoring Molecular Imaging Cancer Treatment Essentially non-invasive method to Broadly expands capabilities of determine tumor size and location convention
Slide 16: Treatment Options Available to Oncologists
Treatment Options Available to Oncologists Multiple and increasingly diverse treatment options are available to oncologists, each with unique modes of intervention, outcomes benefit, and use limitations Targeted radiotherapy (“TRT”) representing an important new treatment option Treatment Alternativ
Slide 17: Targeted Radiotherapeutics Provide Unique Benefits
Targeted Radiotherapeutics Provide Unique Benefits Demonstrated benefit in solid High energy induced tumors where no alternative destruction of cancer cells treatment options are available independent of pathway activity Treats disseminated Ability to non-surgically Targeted diseases with exquisite
Slide 18: Targeted Radiotherapy Debulking of Tumors
Targeted Radiotherapy Debulking of Tumors Advantages Disadvantages Non-invasive Severe side effects Reaches physically inaccessible Chemotherapeutic Unacceptable impact on patient locations Debulking QoL Limited utility Performed under direct Painful visualization Surgical Potential for infection In
Slide 19: Product Overview
Product Overview Leadership in Oncologic Radiopharmaceuticals
Slide 20: Ultratrace Delivers Unique Ultrapure Radiotherapeutics
Ultratrace™ Delivers Unique Ultrapure Radiotherapeutics Current Methods Ultratrace™ Technology Sub-optimal chemistry results in excess Ultratrace™ maximizes delivery of of non-radioactive molecules radioactivity to the tumor Non-radioactive molecules compete for Optimal tumor uptake means improved “
Slide 21: Azedra – Neuroendocrine Cancers
Azedra – Neuroendocrine Cancers Overview Radiotherapeutic product for the Tumor Sites for Azedra Indications treatment of metastatic neuroendocrine tumors, specifically pheochromocytoma, carcinoid and neuroblastoma Adrenal Glands Posterior (Pheochromocytoma Description I-131-Metaiodobenzylguanidine
Slide 22: Azedra – Mechanism of Action
Azedra – Mechanism of Action Developed at the University of Michigan to MIBG Uptake Mechanism image the adrenal medulla MIBG is a substrate for the norepinephrine transporter also known as Uptake-1, which is found in some normal tissues and over- expressed in a range of neuroendocrine tumors Norepin
Slide 23: Azedra – Proven Efficacy
Azedra – Proven Efficacy Efficacy of I-131-MIBG has been demonstrated in children with neuroblastoma and in adults with pheochromocytoma and carcinoid J Clinical Oncology 2007 • 35% RR, improved survival Annals of New York Academy of Science 1073: 465–490 (2006) • 35% RR Cancer 2004;101:1987–93. 200
Slide 24: Clinical Literature Supports Azedra Development
Clinical Literature Supports Azedra Development High-Dose 131I-MBIG Therapy Phase II Study on Response 131I-MBIG Double Infusion for Patients with Malignant to 131I-MBIG Therapy With Autologous Stem-Cell Study Name Pheochromocytoma Refractory Neuroblastoma Rescue for Neuroblastoma Phase I Study N=12
Slide 25: Azedra – Targeted Therapeutic for Neuroendocrine Tumors
Azedra – Targeted Therapeutic for Neuroendocrine Tumors Utilizes the Company’s patented Ultratrace™ technology to target the neuroendocrine cancers: neuroblastoma (children), pheochromocytoma (adults) and carcinoid Demonstrated excellent tumor targeting in initial clinical trials Demonstrated enhanc
Slide 26: Azedra – Points of Differentiation
Azedra – Points of Differentiation Ultratrace technology = Improved product purity Greater tumor uptake Reduced pharmacological toxicity/side effects There are no known effective treatments for relapsed refractory neuroblastoma or pheochromocytoma “Cold carrier” MIBG (I-131-metaiodobenzylguanidine)
Slide 27: Azedra – Development Status
Azedra – Development Status Pheochromocytoma (“pheo”) / Paragangaloima (“para”) Fast Track and Orphan Drug status Phase 1 dosimetry study (IB-11) completed Phase 2a dose escalation study (IB-12) completed Phase 2 therapeutic trial (IB-12b) begun June 2009 Neuroblastoma (“neuro”) P2a MTD study (IB-13
Slide 28: Azedra – IB-12 Study Overview (Adult Pheo/Para)
Azedra – IB-12 Study Overview (Adult Pheo/ Para) Study Overview Process Phase I Dose-Escalation (“IB-12”) Duke University Medical Center, New York Identify the maximum tolerated dose (“MTD”) of Presbyterian Hospital, Rhode Island Hospital Ultratrace iobenguane I 131 Dose escalation began at 6 mCi/kg
Slide 29: Azedra – IB-12 Study Results (Adult Pheo/Para)
Azedra – IB-12 Study Results (Adult Pheo/ Para) Overview of Results Posterior Bone Scans Best response per RECIST was partial response (“PR”) for 3 patients (14%), stable disease for 14 (67%), progressive disease for 2 (10%), and not evaluable for 2 (10%) All 3 PRs were documented at 3 months and co
Slide 30: Azedra – IB12B Study Overview (Phase II Pheo/Para)
Azedra – IB12B Study Overview (Phase II Pheo / Para) Study Overview Key Endpoints Phase 2 Pivotal Efficacy and Safety (“IB12B”) Reduction (at least 50%) in antihypertensive medication Evaluate the efficacy of Azedra in patients with for at least 6 months malignant relapsed/refractory pheo / para Sta
Slide 31: Azedra – IB-N201 Study Overview (Phase II Neuro)
Azedra – IB-N201 Study Overview (Phase II Neuro) Study Overview Key Endpoints Phase 2 Pivotal Efficacy and Safety (“IB-N201”) Proportion of patients with CR or PR by RECIST Evaluate the efficacy of Azedra in patients with criteria over the course of two efficacy assessments relapsed/refractory high-
Slide 32: Trofex – Revolutionary Prostate Cancer Diagnostic
Trofex – Revolutionary Prostate Cancer Diagnostic Overview Radiotherapeutic for the imaging of Trofex Prostate Cancer Imaging prostate cancer Description I-123 radiolabeled small molecule Mechanism Detection of metastatic disease in men of Action with elevated prostate specific antigen (“PSA”), but
Slide 33: Trofex – Superior Imaging Technology
Trofex – Superior Imaging Technology Posterior Planar Image SPECT / CT Fused Slices of 3D Image Normal Normal Kidneys Liver Known Bone Tumor Lesion Unknown Soft Bladder Tissue (Lymph Node) Lesion 33
Slide 34: Trofex – Points of Differentiation
Trofex – Points of Differentiation Potential to change the prostate cancer imaging landscape Current technologies lack both sensitivity and specificity for detecting metastatic disease Small molecular size compounds have a definitive advantage Achieve greater permeability into solid tumors, which le
Slide 35: Trofex – Study Overview (Prostate Cancer)
Trofex – 101 Study Overview (Prostate Cancer) Study Objectives Study Design Examine the PK, organ dosimetry, metabolism and Randomized, single blind, cross-over study patients to safety of 123I-MIP-1072 & 123I-MIP-1095 in patients receive 123I-MIP-1072 & 123I-MIP-1095 10 mCi with with prior histolog
Slide 36: Trofex – Study Results
Trofex – 101 Study Results Tumor Uptake (Not Decay Corrected) Tumor Uptake (Decay Corrected) Tumor to Background Ratios Planar Imaging SPECT Imaging 36
Slide 37: Trofex – Study Conclusion
Trofex – 101 Study Conclusion Both 123I-MIP 1072 & 123I-MIP 1095 detect suspected tumors between 1 & 4 hr post- injection Both compounds have similar tumor uptake and adequate T/B ratios on a per tumor basis 123I-MIP 1072 clears the circulation more rapidly and is excreted renally while 123I-MIP 109
Slide 38: Onalta – Metastatic Carcinoid and Pancreatic Tumors
Onalta – Metastatic Carcinoid and Pancreatic Tumors Overview Radiotherapeutic for the treatment of Tumor Sites for Onalta Indications metastatic carcinoid and pancreatic tumors in patients whose symptoms are not controlled by conventional therapy Posterior Pancreas (Pancreatic Description Yttrium-90
Slide 39: Onalta – Development History
Onalta – Development History Time Event Q2 1997 Originating IND filed with the US FDA 3 Phase 1 trials (n = 66), 3 Phase 2 trials (n = 278) completed 2005 FDA grants Orphan Drug status for the treatment of somatostatin receptor- positive neuroendocrine gastroenteropancreatic tumors Q1 2007 Molecular
Slide 40: Onalta – Points of Differentiation
Onalta – Points of Differentiation Targeted radiotherapeutic with minimal pharmacological side effects Chemotherapy with single or combination cytotoxic agents has produced little benefit Currently, patients with an endocrine-active tumor that cannot be treated by surgery are given drugs to decrease
Slide 41: Onalta – Opportunities in the EU
Onalta – Opportunities in the EU Currently being utilized as a first-line or second-line treatment for refractory, somatostatin- positive patients in the EU Current patient population is unsatisfied and seeking new options Metastatic pancreatic neuroendocrine tumors (PNET) affect ~7,500 patients; ~7
Slide 42: Onalta – Sub-Licensing Agreement
Onalta – Sub-Licensing Agreement Overview Sub-licensed Onalta in June 2009 to BioMedica Life Sciences, S.A., for distribution in certain countries in Europe, Middle East, North Africa, Russia and Turkey - BioMedica receives exclusive sub-license to intellectual property rights and know- how - Onalta
Slide 43: Onalta – Clinical Program Overview
Onalta – Clinical Program Overview Summary Clinical Benefits 338 patients treated with 90Y-edotreotide Majority (85%) of patients with refractory carcinoid reported improvement in at least one symptom Administered doses ranged from 1.8 – 32.6 GBq Nearly half (49%) reported improvement in four or Mea
Slide 44: Solazed – Therapeutic for Malignant Metastatic Melanoma
Solazed – Therapeutic for Malignant Metastatic Melanoma Overview Targeted radiotherapeutic for treatment Tumor Sites for Solazed Indications of malignant metastatic melanoma Description Ioflubenzamide I 131 Mechanism The drug selectively binds to melanin of Action that is found in high concentration
Slide 45: Solazed – Points of Differentiation
Solazed – Points of Differentiation Selective targeting of metastatic melanoma Selective delivery of radiation to tumors Highly effective in human models of melanoma Minimal pharmacological toxicity of nonradioactive Solazed 45
Slide 46: Solazed – Pre-Clinical Data
Solazed – Pre-Clinical Data 20 15 saline 1 x Solazed 10 2 x Solazed 3 x Solazed 3 x dacarbazin 5 3 x Solazed + 3 x dacarbazin 0 0 25 50 75 100 125 Time after initiation of treatment (days) 46
Slide 47: Zemiva – Improved Cardiac Ischemia Imaging
Zemiva – Improved Cardiac Ischemia Imaging Overview Diagnostic product for the early Myocardium Metabolism detection of ischemic myocardium via SPECT imaging in conjunction with During Ischemic Event early standard cardiac diagnostic data Description Iodofiltic acid I 123 Mechanism Binds to fatty ac
Slide 48: Zemiva – Cardiac Ischemia
Zemiva – Cardiac Ischemia Detection and management of cardiac ischemia by imaging metabolic changes in the heart in the emergency department acute setting Cardiac tissue shifts from fatty-acid metabolism to glucose metabolism when ischemic Healthy cardiac tissue accumulates Zemiva but ischemic tissu
Slide 49: Zemiva – Imaging Capabilities
Zemiva – Imaging Capabilities Angiogram Zemiva SPECT Images A large defect is observed with Zemiva in the lateral wall, consistent with the stenosis and the potential culprit lesion seen in the left circumflex coronary artery in the angiogram 49
Slide 50: Zemiva – Market Opportunity
Zemiva – Market Opportunity 6 Million Patients Annually Admitted to Emergency Departments for Potential Heart Attacks 1.5 Million Patients 3.5 Million Patients 1.0 Million Patients Ischemia Ruled Out Equivocal Definitive Heart Attack Discharged Admitted for Observation Admitted for (40,000 Missed ($
Slide 51: Zemiva – Points of Differentiation
Zemiva – Points of Differentiation Current Chest Serial Admit to Stress Perfusion Time: 86 Hours Standard Serial Enzymes Observation X-Ray ECGs Hospital Test Imaging Cost: $7,500(1) of Care Zemiva Time: <1 Hour Zemiva Imaging Cost: $1,750 – 2,250(1) Provides improved visualization that leads to more
Slide 52: Intellectual Property Overview
Intellectual Property Overview Azedra: The Company has in-licensed patents and a pending application from The University of Western Ontario that relate to the precursor material, a process of preparing the precursor material, and the Ultratrace™ technology used to produce Azedra™ These patents are s
Slide 53: Key Milestones and Offering Discussion
Key Milestones and Offering Discussion
Slide 54: Recent Molecular Insight Milestones
Recent Molecular Insight Milestones Event Timing Clinical Advances Azedra into pivotal Phase II therapeutic trial 3Q 2009 Receives EMEA approval to proceed with Phase III trial of Onalta 2Q 2009 Releases positive Phase II exploratory trial results for Zemiva(1) 1Q 2009 Corporate Licenses Onalta for
Slide 55: Upcoming Molecular Insight Milestones
Upcoming Molecular Insight Milestones Event Timing Clinical Begin Phase III Confirmatory Trial for Onalta in EU 1H 2010 Complete Phase I Clinical and Nonclinical Trofex Studies 1H 2010 Initiate Azedra pivotal Phase II study in neuroblastoma 1H 2010 Submit Azedra NDA for neuroblastoma 2011 Begin Phas
Slide 56: Ownership and Capitalization
Ownership and Capitalization Ownership as of 6/30/09 Proceeds from offering to fund Azedra and Top 10 Holders # of Shares (MM) % Out Trofex clinical development and enhance Cerberus Capital Management, L.P. 3.7 14.8% Barlow, David S. 2.7 10.7% the Company’s liquidity position Savitr Capital, LLC 2.1
Slide 57: Investment Highlights
Investment Highlights Pioneer in the emerging field of molecular medicine Five clinical-stage candidates addressing seven indications with significant unmet patient needs with no visible potentially competing products in development Significant near-term partnering opportunities in oncology and card
Slide 58: Investment Highlights (continued)
Investment Highlights (continued) Commitment of Cerberus and other existing investors to participate in current fund raise provides validation of products and strategy Business development opportunities are anticipated to supply a significant portion of the needed cash for further advancement of the
Molecular Insight Pharmaceuticals — Investor Presentation (December 2009) on 6ix