IDSC From Hit to the Clinic… Your Drug Discovery & Development Partner Mark Creswell President and CEO markcreswell@idscbiotechnetwork.com Phone: 734.433.9670 Cell: 734.476.4097 IDSC CONFIDENTIAL IDSC From Hit to the Clinic… Your Drug Discovery & Development Partner Capabilities ● Expertise ● Services & IDSC’s Oncology Discovery & Development Team 9/18/2018 WWW.IDSCBIOTECHNETWORK.COM

Integrated Team of Specialists Oncology Team (small subset): Preclinical & oncology expert & project leadership Preclinical & oncology expert & pharmacology Oncology clinicians (MD) ADME Analytical development & CMC Commercial assessment & valuation Formulation Regulatory Toxicology Preclinical & oncology expert & medicinal chemist Who is IDSC? Integrated Team of Specialists 1 Interdisciplinary group 10 2 9 55 Ex-pharma leaders 25 Years pharma experience 3 8 Sr. VPs, VPs, Executive Directors 4 Careers in: 7 Big pharma 5 6 Biotech companies Post career consulting 9/18/2018 WWW.IDSCBIOTECHNETWORK.COM

Stages of Drug Discovery & Development IDSC’s Services Span: Discovery Development Hit to Lead Lead Optimization Preclinical Development to IND Filing Clinical Development Evaluate HTS Hits or SBDD Results Select lead Series Optimize Properties, Synthesis, SAR Identify Clinical Candidate FDA Pre-IND Meeting Draft & Submit IND FDA Phase 2 Meeting Draft & Submit NDA Medicinal Chemistry ADME Pharmacology Early Safety Molecular Modeling ADME & PK/PD Modeling Formulation Regulatory Compliance Analytical Development Clinical Study Design Toxicology & Pathology Drug Product Fill & Finish Clinical Operations Process Development Commercial Assessment & Valuation API Management CMC Regulatory 9/18/2018 WWW.IDSCBIOTECHNETWORK.COM

Why Clients Come to IDSC Drug Discovery Interim Leadership Filling the gaps Most major TAs Very strong & deep in oncology All line disciplines Biologics, small mols., stem cells, diagnostics, devices, nutraceuticals Consulting Most major TAs All line disciplines Very strong & deep in oncology Biologics, small mols., stem cells, diagnostics, devices, nutraceuticals Preclinical Development Clinical Development Due Diligence Investment opportunities Program reviews SWOT analyses For venture capitalists For pharma & biotech companies For academics Fully Integrated Collaborations IDSC supplies a full or partial project team to our client. All discovery, preclinical development, or clinical development line discipline experts. Molecular Modeling Structure-based design Ligand-based design Structural Bioinformatics Cheminformatics Biologics and small molecules Outsourcing Management Medchem, API/ biological, pharmacology, toxicology, ADME, etc. Parts of clinical that IDSC does not run ourselves Identify CROs & CMOs Manage CROs & CMOs Commercial Assessment Commercial assessment & valuation Market Research Quantitative & Qualitative KOLs, Payers, etc Forecasting Net Present Values IDSC does not have laboratories and does not provide lab services... IDSC is a team of 55 consultants providing leadership to our clients. We do, however manage our clients’ outsourcing efforts 9/18/2018 WWW.IDSCBIOTECHNETWORK.COM

Examples of What Our Leaders Do TA Experts and Project Leaders Advise client on oncology, indication, & tumor type. Prepare program reviews Lead teams in preparation of gap analyses and development plans Serve as project leader for project teams Medicinal Chemists Antibacterial expert Evaluates SAR & decides what compounds to make Knows oncology and blood disorder requirements & ADME & designs compounds to optimize ADME, potency, efficacy, & market profile Designs synthesis and manages outsourcing ADME, Toxicologists, Pharmacologists Design in vitro and in vivo studies Identify ADME & Toxicology CROs Identify in vitro & in vivo oncology CROs & manage outsourcing Evaluate study data and write IND submission study reports Make decisions based on study results & program goals API & CMC Managers Identify CMOs (oncology appropriate if needed) and manage outsourcing Chemistry, biologicals, cell lines… Optimize chemistry process Troubleshoot biologicals Submit regulatory registrations API, CMC, cell lines, formulation, analytical, and, fill & finish, etc Regulatory Experts Guide client and IDSC team on and assure guidelines for the appropriate FDA division are met Assist client with preparation for and accompany client to regulatory agency meetings Assist client with preparation of and submission of regulatory documents Clinical Development and Operations Leader Point of Accountability and POC Develop corporate clinical strategy Develop & manage clinical operations Oversee clinical trials Manage timeline & budget Clinicians Support indication / tumor type preclinical development plan Draft clinical protocols & plan for specific indication / tumor type Participate in and/or lead clinical advisory boards & identify KOLs Oversee aspects of clinical trials Advise client, preclinical, and clinical project teams Clinical Operations Clinical leadership & Project management Biostatistics Study management Site monitoring Data capture & management Medical writing Recruitment & Retention IDSC is a team of 55 consultants providing leadership to our clients… We do not have laboratories and do not provide lab services. We do, however manage our clients’ outsourcing efforts. 9/18/2018 WWW.IDSCBIOTECHNETWORK.COM

Line Discipline Expertise Preclinical & Clinical Development Drug Discovery Biologics ● Small Molecules Stem Cells Devices Diagnostics Nutraceuticals ADME & PK/PD/TK modeling Toxicology & pathology Process development/ API Mgmt / CMC Formulation, analytical, fill & finish Clinical Study Design (MD clinicians) Regulatory Support, including: Regulatory Agency Meetings Document Preparation & Submission Clinical Operations Commercialization Strategy Product Assessment & Valuation Market Research Medicinal Chemistry Molecular Modeling Pharmacology in vitro in vivo ADME 9/18/2018 WWW.IDSCBIOTECHNETWORK.COM

IDSC Team Members Contracted as: Discovery Preclinical Development Client KOLs Directors Management: Information & Data Sample logistics Decision funnel CRO management IDSC Discovery Preclinical Development Clinical Development Team FDA Oncology Clinicians (MD) Regulatory (oncology) Study Sites Clinical Pharmacology API, CMC, Analytical, Formulation Oncology Expert, PM, & POC Team Members Contracted as: ADME PK/PD/TK Modeling Toxicology Individuals Clinical Operations Med-Chem or Biologics, & Pharmacology Small Teams Fully Integrated Collaborations The team grows and contracts as needed as the asset moves down the development continuum. ADME CROs Imaging & Pharmacology CROs Analytical labs, Clinics, &/or Clinical CROs Toxicology CROs API prep, Cell lines, etc. CROs 9/18/2018 WWW.IDSCBIOTECHNETWORK.COM

IDSC Clinical Development & Clinical Operations Client KOLs IDSC Directors & Staff Clinical Development & Clinical Operations Study Sites FDA Clinician (CMO) Regulatory & Document Submission Clinical Pharma-cologist Biostats Keys To Success: Team can make key decisions Excellent project leadership Excellent communication Excellent project management Significant Operations expertise Goal oriented team Manage streamlined logistics process Clinical Dev/Ops Leader & POC Site Monitors Medical Writers Study Managers E-Data Capture & Management API, Analytical, Formulation, CMC, Fill & Finish Abbreviations: POC: point of contact CMO: chief medical officer CROs & CMOs: contract research organizations & contract manufacturing organizations CROs & CMOs: Clinical PK Analysis API, Final Dosage Form, Fill & Finish, Analytical Clinical CROs (if needed) IVRS, Electronic Data Capture Software 9/18/2018 WWW.IDSCBIOTECHNETWORK.COM

Key Oncology Project Team Members: Alex Bridges, PhD:  28 years big pharma, 6 years Academics, 5 yrs biotech, oncology, metabolic disease, medicinal chemistry, Executive Director at Pfizer, Dacomitinib (phase III), Palbociclib (Phase III). Bob Zimmerman, PhD: 25 years big-pharma, biotech, biologics, antibacterials, oncology, pharmacology, large and small species, recombinant proteins, monoclonal antibodies, vaccines, and engineered proteins. Anne Norment, MD, PhD: 20 years biotech, immunology, oncology, pharmacology, translational research, project leadership. Lori Dostal, PhD, DABT: 26 years big pharma & consulting, reproductive & developmental toxicology, general toxicology, juvenile toxicology, neurotoxicity, fertility studies, pre-IND to NDA. Lazo Radulovic, PhD: 20 years big pharma, 5 yrs consulting, ADME, small molecule & biologics, nonclinical safety assessments, FDA interactions, regulatory responses, preparation of NDA item 5 for marked drugs. Mark Ammann, PharmD: 21 years experience in regulatory strategy (Novartis, Pharmacia, Pfizer) involving numerous IND and NDA approvals. Mary Zimmerman, MS: 25 years biotech, SVP, regulatory affairs & strategy, IND, CTA, INPD, CTD submissions, Alzheimers disease, MS, oncology, antibacterials, asthma. Rick Stead, MD: 24 years experience, clinical and regulatory strategy for development of biotechnology products, including oncology and hematology products, academic experience in hematology & coagulation. Karen Steffen, BS: 16 years biotech, API management, small mols, biologicals, cGMP, senior project and operations management, EHS officer, facility management, budget management, IMPD, IND, NDA, MAA. API management, Formulation, Analytical Development, CRO/CMO management, Clinical operations, Fill & finish, CMC, etc. In addition to 20-30 years pharma experience, the IDSC oncology team members have 3-7 years of consulting experience working on virtual teams for clients. 9/18/2018 WWW.IDSCBIOTECHNETWORK.COM

Why Partner with IDSC: Summary IDSC’s clients come to us for both ad hoc consulting & project based consulting and individual directors, multiple directors, and/or entire project teams. IDSC’s directors have contributed collectively to multiple oncology drugs in the clinic or on the market: Proleukin®, Epogen®, Neupogen®, Femara®, Sandostatin® LAR, Gleevec®, Zometa®, Dacomitinib (phase III), Palbociclib (Phase III) for example. IDSC brings its clients a pool of 31+ oncology team experts to utilize as needed: Oncology experts: 2 medicinal chemists, 1 in vitro pharmacologist, 2 in vivo pharmacologists, 1 in vivo pharmacologist / project leader, 3 clinicians, 1 biostatistician, 2 regulatory experts, multiple clinical development & operations leaders, clinical operations personnel Supporting personnel : 1 PK/PD modeler, 1 ADME expert, 1 clinical pharmacologist & PK/PD modeler, 3 toxicologists, 1 biostatistician, 3 API managers, 2 formulations experts, 1 analytical development expert, 1 fill & finish expert, 2 CMC/regulatory experts, clinical operations personnel IDSC’s 55 directors average 25 years of experience in big pharma, biotech, and academia plus consulting experience and have been Sr. VPs, VPs, & Exec. Directors. IDSC’s Regulatory Experts: Large pharma, FDA, small biotech, multiple drug approvals 9/18/2018 WWW.IDSCBIOTECHNETWORK.COM

For More Information, Visit: www.idscbiotechnetwork.com 9/18/2018 For More Information, Visit: www.idscbiotechnetwork.com THANK YOU Mark Creswell President & CEO 310 N. Main St. Suite 204 Chelsea, MI 48118 USA Phone: 734.433.9670 Fax: 734.433.9671 Cell: 734.476.4097 markcreswell@idscbiotechnetwork.com 9/18/2018 WWW.IDSCBIOTECHNETWORK.COM