IDSC From Hit to the Clinic…Your Drug Discovery & Development Partner Mark Creswell President and CEO markcreswell@idscbiotechnetwork.com IDSC CONFIDENTIAL Phone: 734.433.9670 Cell: 734.476.4097 The Expertise & Value IDSC’s Biologics Ophthalmology Development Team Brings Our Clients IDSC From Hit to the Clinic…Your Drug Discovery & Development Partner 4/29/2019 WWW.IDSCBIOTECHNETWORK.COM

Integrated Team of Specialists Ophthalmology Team: Who is IDSC? Integrated Team of Specialists 1. Ophthalmic clinical development & regulatory, 10 1 2. Clinical development & operations leader, Interdisciplinary group 9 2 3. ADME, 65 Ex-Pharma Leaders 8 3 4. Toxicology, 25 yrs Pharma Experience 5. Clinical pharmacology & PhI to PhII PK modeling Sr. VPs, VPs, Exec. Directors 6. Formulation, Careers in: 4 7. Analytical development & CMC, 7 Big Pharma Biotech Companies 8. Regulatory, 6 5 9. Clinical operations team, Academia Post Career Consulting 10. Commercial assessment & valuation, 4/29/2019 WWW.IDSCBIOTECHNETWORK.COM

IDSC Supports All 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 Clinical Operations & Medical Monitoring Medicinal Chemistry Pharmacology Molecular Modeling ADME Early Safety ADME & PK/PD Modeling Drug Product Fill & Finish Toxicology & Pathology CMC Regulatory Process Development Regulatory Compliance API Management Clinical Study Design Formulation Clinical Operations Analytical Development Commercial Assessment & Valuation 4/29/2019 WWW.IDSCBIOTECHNETWORK.COM

Why Clients Come to IDSC Drug Discovery Interim Leadership Consulting Filling the gaps Most major therapeutic areas All line disciplines Small molecules., biologics, stem cells, diagnostics, devices, nutraceuticals Most major therapeutic areas All line disciplines Small molecules., biologics, stem cells, diagnostics, devices, nutraceuticals Preclinical Development Clinical Development Due Diligence Fully Integrated Collaborations Molecular Modeling Commercial Assessment Outsourcing Management Investment opportunities Program reviews SWOT analyses For venture capitalists For pharma companies For academics Structure-based design Ligand-based design Structural Bioinformatics Cheminformatics Small molecules and biologicals Commercial assessment & valuation Market Research Quant & Qual KOsL, Payers, etc Forecasting Net Present Values Medchem, API/ biological, pharmacology, toxicology, ADME, etc. Parts of clinical that IDSC does not run ourselves Identify CROs & CMOs Manage CROs & CMOs IDSC supplies a full or partial project team to our client. All discovery, preclinical development, or clinical development line discipline experts. 4/29/2019 WWW.IDSCBIOTECHNETWORK.COM

Help YOUR company? Can A Group With: A Point of Clarity… IDSC does not have laboratories and does not provide lab services... IDSC is a team of 65 consultants providing leadership to our clients. We do, however manage our clients’ outsourcing efforts. A Rhetorical Question… Can A Group With: Over 1600 years of pharma experience; Expertise across the major therapeutic areas; Expertise in all the disciplines in the discovery & development continuum from… Hit ID to launch in… Small molecule & biologics therapeutics, stem cell therapies, disease diagnostics, medical devices, and nutraceuticals… Help YOUR company? 4/29/2019 WWW.IDSCBIOTECHNETWORK.COM

Examples of What Our Leaders Do TA Experts and Project Leaders ADME, Toxicologists, Pharmacologists Head Ophthalmic Clinical Development & Strategy API & CMC Managers Identify CMOs 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 Support ophthalmic preclinical development plan Draft clinical plan & protocols for ophthalmic clinical trials Participate in and/or lead clinical advisory boards & identify KOLs Advise client, preclinical, and clinical project teams Advise client on therapeutic area and disease indication Prepare program reviews Lead teams in preparation of gap analyses and development plans Serve as project leader for project teams Design in vitro and in vivo studies Identify ADME & Toxicology CROs Identify in vitro & in vivo indication specific CROs & manage outsourcing Evaluate study data and write IND submission study reports Make decisions based on study results & program goals Regulatory Experts Clinical Development and Operations Leader Clinicians Clinical Operations Clinical leadership & Project management Biostatistics Study management Site monitoring Data capture & management Medical writing Recruitment & Retention 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 Support the indication preclinical development plan Draft clinical protocols & plan Participate in and/or lead clinical advisory boards & identify KOLs Oversee clinical trials Advise client, preclinical, and clinical project teams Point of Accountability and POC Develop corporate clinical strategy Develop & manage clinical operations Oversee clinical trials Manage timeline & budget IDSC is a team of 55 consultants providing leadership to ur clients… We do not have laboratories and do not provide lab services. We do, however manage our clients’ outsourcing efforts. 4/29/2019 WWW.IDSCBIOTECHNETWORK.COM

Line Discipline Expertise Drug Discovery Preclinical & Clinical Development Medical Markets Medicinal Chemistry Molecular Modeling Pharmacology in vitro in vivo ADME Small Molecules ● Biologics Stem Cells Devices Diagnostics Nutraceuticals ADME & PK/PD/TK modeling Toxicology & pathology Process chemistry/ API mgmt. / CMC Formulation, analytical, fill & finish Clinical study design, MD, CMO Regulatory support, including: Regulatory agency meetings Document preparation & submission Clinical operations Commercialization strategy Product assessment & valuation Market research 4/29/2019 WWW.IDSCBIOTECHNETWORK.COM

Is Your Development Plan in Place? Program Review Gap Analysis Development Plan Program Review Often early in preclinical (Discovery) Often performed by 1 director (consultant) Review of client’s early data, issued patents, patent applications, & relevant literature Provide client with a SWOT (strengths, weaknesses, opportunities, threats) analysis. Provide brief scientific next steps needed, generally to move the project to the next stage such as a funding spinout, out-licensing, VC funding, etc. Provide a brief written report or teleconference or both Often 10-20 hours of consulting work Gap Analysis Often performed late in preclinical development Often performed by multiple directors (consultants) Review client’s in vitro, in vivo efficacy, ADME, & tox data, issued patents, patent applications, and relevant literature, clinical plan, & IND ready study reports Provide client with key studies and protocols that are missing from the technical package & and regulatory information needed to get to IND submission. Provide a detailed written report and a teleconference call Depending on # of directors and therapeutic area, it can take 25-115 hours of consulting work (1-8 directors) Often performed when clinical candidate is identified Performed by 1-8 directors (client’s budget dependent) Review client’s in vitro, in vivo efficacy, & ADME data, issued patents, patent applications, and relevant literature Provide client with needed efficacy, ADME, & tox studies, protocols, timeline, budget, regulatory needs, and cohesion with a PhI clinical plan to get to an IND submission Provide a detailed written report and a teleconference call Depending on # of directors and therapeutic area, can take 25-230 hours of consulting work (1-8 directors) Development Plan 4/29/2019 ©2013 IDSC, LLC

IDSC Team Members Contracted as: KOLs Client Discovery Preclinical Development Clinical Development Team Study Sites FDA Ophthalmology Clinician (MD) Regulatory Ophthalmology Team Members Contracted as: Clinical Pharmacology API, CMC, Analytical, Formulation Individuals TA Expert, PM, & POC ADME PK/PD/TK Modeling Toxicology Small Teams IDSC Fully Integrated Collaborations Clinical Operations Directors Management: Information & Data Sample logistics Decision funnel CRO management Med-Chem & Pharmacology The team grows and contracts as needed as the asset moves down the development continuum. Abbreviations: POC: point of contact CMO: chief medical officer CROs & CMOs: contract research organizations & contract manufacturing organizations CROs & CMOs: ADME CROs Ophthalmology Pharmacology CROs Analytical labs, Clinics, &/or Clinical CROs Toxicology CROs Chemistry & API Scale Up CROs 4/29/2019 WWW.IDSCBIOTECHNETWORK.COM

IDSC Clinical Development & Clinical Operations FDA Directors Client KOLs Clinical Development & Clinical Operations Ophthalmology Clinician (MD) Regulatory & Document Submission Ophthalmology Study Sites FDA IDSC Clinical Ops Team Will Provide: Program leadership Project management Site assessment & selection Patient recruitment & retention Tool kits, Dear Dr. referral letters Timeline & budget management Site management Site monitoring Budget development Contract & budget approval facilitation Data management Real time data monitoring & capture Clinical Pharma-cologist Biostats Clinical Dev/Ops Leader & POC Site Monitors Medical Writers IDSC Keys To Success: Team makes key decisions Excellent project leadership Excellent communication Excellent project management Directors & Staff Study Managers E-Data Capture & Management Significant operations expertise Goal oriented team Manage streamlined logistics process API, Analytical, Formulation, CMC, Fill & Finish CROs & CMOs: Abbreviations: POC: point of contact KOL: Key Opinion Leader CMO: chief medical officer CROs & CMOs: contract research organizations & contract manufacturing organizations Clinical PK Analysis API, Final Dosage Form, Fill & Finish, Analytical Clinical CROs (if needed) IVRS, Electronic Data Capture Software 4/29/2019 WWW.IDSCBIOTECHNETWORK.COM

Key Ophthalmology Project Team Members Ophthalmic Regulatory Strategy & Clinical Development: 32 years biotech & consulting, small molecules, proteins, antibodies, VP clinical & regulatory at Dow Pharma Services, VP regulatory, clinical, and quality at Fibrogen, Inc., multiple ophthalmology IND submissions Toxicology: 28 year big pharma, toxicology, dermatotoxicology, senior director dermatology drug safety R&D, dermatologics, multiple TAs including dermatology & Ophthalmology. ADME: 28 year big pharma, nonclinical safety assessments, research fellow drug safety R&D, develop toxicology testing paradigm for dermatologics, dermatotoxicology Clinical Development Leadership & Operations :  26 years big pharma & small biotech, clinical development & corporate strategy, program management, clinical operations, stem cell therapies, CV, CNS, oncology, women’s health, inflammation. Clinical Pharmacology: 30 years big pharma, clinical pharmacology & PK/PD, multiple TAs including ophthalmology, study, data analysis, population PK & PK/PD, INDs, NDAs, JNDAs, MAAs, FDA, EMA, BfArM, Health Canada, MPA. Manufacture Management: 16 years biotech, API management, small molecules, biologicals, cGMP, senior project and operations management, EHS officer, facility management, budget management, IMPD, IND, NDA, MAA. Cell line and Protein Manufacture Management: 22 years biotech & consulting, API management, small molecules, biologicals, cGMP, manufacturing, supply chain, contract negotiation, audits, CMC regulatory, QA & QC, bioanalytical methods, CRO/CMO management. Biologics Formulation: 30 years biotech; biologics; process development, formulation, analytical development, CMC, lyophilization, and stability. Commercial Assessment & Valuation: 32 years big pharma and consulting; commercial strategy, market & product assessment, valuation, lifecycle planning, marketing, advisory boards. Analytical Development, CRO/CMO management, Clinical operations, Fill & finish, CMC, etc. 4/29/2019 WWW.IDSCBIOTECHNETWORK.COM

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 4/29/2019 WWW.IDSCBIOTECHNETWORK.COM