Post on 11-Nov-2020
ENABLING NEXT-GENBIOLOGICSCORPORATE PRESENTATIONTom Isett, Co-Chairman and CEO
Statements included in this presentation related to iBio, Inc. may constitute forward-looking statementswithin the meaning of the private securities litigation reform act of 1995. Such statements involve a numberof risks and uncertainties such as competitive factors, technological development, market demand, and thecompany's ability to obtain new contracts and accurately estimate net revenues due to variability in size,scope and duration of projects. Further information on potential risk factors that could affect the company'sfinancial results can be found in the company's reports filed with the securities and exchange commission.
Forward-Looking Statements
OverviewBiologics Company Contract development &
manufacturing org [CDMO] adding innovative, proprietary products
FastPharming SystemTM
Novel mfg platform enables rapid production of high-quality biological medicines in plants
CDMO Services Addressing $6B market, including 3D Bioprinting
Therapeutics Lead asset targets >$10B market for fibrotic diseases
Robert B. KayCo-Chairman
• Accomplished business strategist, senior manager with M&A, JV, international licensing expertise
• JD from New York University (NYU); BA from Cornell University
James P. Mullaney, CPAChief Financial Officer
• 20+ years experience leading finance functional excellence
• Former member of PwC’s Audit practice, KPMG’s CFO Advisory Services practice
Thomas F. IsettCEO and Co-Chairman
• Business leadership for bioprocess businesses during 25 combined years with GE, Lonza and BD
• Advisory and/or leadership roles in >$20B of M&A transactions
• Founded BD Advanced Bioprocessing, Commence Bio, Inc., and i.e. Advising, LLC
Robert L. ErwinPresident
• Founded Large Scale Biology Corporation
• Chairman, Icon Genetics AG for 7 years; current Chairman of the Board for privately held Novici Biotech
Management Team New Member Joins Experienced Team
TECHNOLOGYPLATFORM
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The FastPharming System Using Plants as Bioreactors
Harvest
iBio Plants
Agrobacterium
Gene Transfer Bioproduction
Purification Fill/Finish
Parallel Path Saves Months vs. Traditional Methods
FastPharming SystemAdvantages
• Saves months of development time vs. competing methods
• Research quantities available in just 8 weeks
• cGMP material in as little as 8 months
Faster• No expensive, labor-intensive cell
line development• Avoids scale up challenges; just
grow more plants• Glycosylation controls for
increased molecule quality/potency• Lower upfront facility expense v.
mammalian cell culture systems
Better• Lower contamination risks:
mammalian viruses can’t grow in plants
• Avoids plastic waste associated with competing “single-use systems”
Safer & Greener
“Compared with proteins derived frommammalian cells, proteins from geneticallyengineered plants are easy to scale up andsynthesize with other proteins, and they remainstable at room temperature for longer periods”
WSJ, July 19, 2019
iBio FY’20 Announced Deals
CC-Pharming
Plant-Based ManufacturingGaining Traction
“…timelines are constantly being challenged and there arecontinued calls for faster commercialization…the traditionalprocessing methods are proving to be a bottleneck”
“Now that plant expression technology has matured andproven its commercial viability, it is increasingly recognizedas a valid manufacturing option”
BioPharm International, June 1, 2019
BUS INESSOVERV IEW
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CoreLaunched new FastPharmingbrand and services to gain share of $6B biologics CDMO market
AdjacentEntering high-growth 3D Bioprinting materials segment using FastPharming’s strengths
Factory SolutionsEnabling clients to insource FastPharmingTechnology via “design & build” turn-key facility offering
ObjectivesValue creation in services and proprietary products while aggressively defending IP
TherapeuticsAdvancing IBIO-100 for the treatment of fibrotic diseases
New InitiativesStrategic Thrusts to Drive Growth
CDMO ServicesCore Capabilities
Fill and Finish Services• New F/F offering launched June 2019• First (gene therapy) client won mid-June • Line extension for 5mL fills planned for Q4’FY20
• Increase revenue capacity
FastPharming Biologics Mfg Services• New brand, website, and commercial strategy• Introducing glycan engr. services for Ý potency• iBio expanding range into advanced biologics1
• Positioned to rapidly produce both COVID-19 vaccine and therapeutic products
• Serving $6B biologics CDMO market growing >9%
1e.g. 3D-bioprinting & biofabrication materials
CDMO Services Expanding Capabilities
FastPharming Biologics Mfg Services• Dec 2019: FastGlycaneering for Ý molecule potency• Aug 2019: Bioinks for 3D Bioprinting• Jun 2019: “Fill and Finish” packaging services
State-of-the-Art Facility• Automated hydroponics and vertical farming processes
• 130,000 sq.ft., centrally located cGMP facility
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COVID-19 ManufacturingUniquely Positioned for Rapid Response
Vaccine Development: iBio/CC-Pharming Collaboration• Leverages 25 years of vaccine R&D experience, inclusive of:
- MERS-coronavirus work by CC-Pharming Chairman & CSO- iBio’s IP in rapid design of plant-based manufacturing processes
• Ability to rapidly scale-up vaccine candidate production for testing
170,000confirmed cases
Source: Johns Hopkins Coronavirus Resource Center
156countries with cases
6,500deaths
Vaccine & Therapeutics Manufacturing• iBio facility built in 2010 with funding from Defense Advanced Research
Projects Agency [DARPA]
• Part of the “Blue Angel” initiative to establish facilities capable of rapid delivery of medical countermeasures to a pandemic
• FastPharming Technology has been used to produce antibody candidates for Dengue and Yellow fever viruses
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Related COVID-19 Technology Development Provisional Patent Filings for Two Prospective Vaccine Platforms
LicKMVirus Like Particle
March 12, 2020: iBio disclosed new patent filings for its Virus Like Particle [VLP] platform technology, or its lichenase carrier immunostimulatory (“LickM”) adjuvant technology (US Patent 9,012,199), in conjunction with its FastPharming
Manufacturing System for treating or preventing infections with the SARS-CoV-2 virus
Adjacent CDMO Services BioInks to Support 3D-Bioprinting
0
20000
40000
60000
80000
100000
120000
140000
160000
180000
FastPharming is uniquely suited to advanced bioink mfg• Safer: Mammalian viruses don’t grow in plants• Quicker: Shortened time-to-market• Better: Easier to scale-up to large quantities for whole organs
United Therapeutics (Aug 2019) Multi-year bioink development and supply agreement
From organdonor.gov
Demand gap creates market for 3D-Bioprinted tissues and
organs…
>$2B industry>$1B supplies
by 2025
Donors
Transplants
WaitingList
U.S. Organ Shortage
Courtesy of United Therapeutics
Factory SolutionsAllows Clients to Insource FastPharming Technology
Facility “Design & Build” Services• Factory Solutions for clients using iBio’s FastPharming
System: “In country, for country”• Factory Solutions for plant-based bioprocessing without
FastPharming Technologies• Turn-key bioprocess facilities market ~$2B
Business Model Example: CC-Pharming, Ltd.• Revenue recognition of $1.8M through FYE’19• New Research License for other “biomaterials”
• Royalties on CC-P biosimilar rituximab sales in China
TherapeuticsIBIO-100 for Fibrotic Diseases
Fibrotic Disorders – Many Unmet Medical Needs• Involved in ~45% of U.S. deaths from all diseases• No cures - organ transplants undertaken in some late-stage diseases• Limited number of palliative treatments for most indications• Many patients forego currently available treatments due to poor tolerability
IBIO-100• Endostatin E4 peptide that reduces fibrosis by impacting extracellular matrices • Strong pre-clinical data: Reduced skin thickness/fibrosis in scleroderma/IPF models and reduced fibrotic tissue in human lungs removed for transplant
• Optimally produced in iBio’s FastPharming System• iBio received Orphan Drug Designation for systemic scleroderma • Intrinsic properties enable a product that could be dosed orally
IBIO-100Collagen Derivative
22%
45%
28%
5%
Dynamic, Continuing IP Development with Appropriate Global Protection
International Patent
Applications
U.S. Patent Applications
U.S. Patents
International Patents
Issued Patentsin various countries (26 U.S.)
80+Active Patent Applications(26 U.S.)
39+
More Applicationsprogressing to filing
Inventionsaddress technologies, products, methods, processes
iBio v. FraunhoferAggressively Defending Intellectual Property
Fraunhofer USA (“FhUSA”) Litigation• Memorandum opinion in Delaware Court of Chancery (2016) and other developments favor iBio• Depositions completed; trial currently scheduled for May 4-15, 2020• Litigation costs and expenses related to current counsel fully-funded through appeal
New Motion Filed to Include German Parent of FhUSA• January 2020 motion filed based upon learnings from 2019 depositions/documents• Fraunhofer-Gesellschaft illicitly used iBio’s IP with new and different 3rd parties
Value Proposition
• Process Development
• cGMP Manufacturing
• Fill / Finish
• Bioanalytics
• Quality & Regulatory
• Factory Solutions
Biologics CDMO Market: $6B• Added Fill/Finish• Launching Factory Solutions • Adding bioanalytics
capability
CDMO Services
• Speeds time-to-market vs. traditional approaches
• Powerful glycan engineering tools can increase product potency and quality
• Easy, consistent scale-up
IP Well Protected• 80 issued patents in various
countries (26 U.S.)• 39 active patent applications• Aggressively defending
FastPharming
• Addresses unmet medical needs for fibrotic diseases
• U.S. Orphan Drug Designation for systemic scleroderma
• Next milestones: Toxicology and cGMP manufacturing
Fibrosis Market: >$10B• ~125K patients in U.S. alone• ~60% forego treatment
IBIO-100 Anti-Fibrotic
• Contract manufacturing of “animal free” bioinks used in 3D bioprinting of tissues and organs
• Plants provide other advantages over competing expression technologies
Bioprinting: ~$1B by 2025• United Therapeutics:
catalyst for iBio’s supply of biomaterials to new, high-growth segment
• Launching marketing efforts in bioprinting sub-segment
3D-Bioprinting
Investment Summary
Core CDMO ServicesDifferentiating offering in core biologics CDMO market: From monoclonal antibodies to COVID-19 vaccines
New & Adjacent ServicesAdding new services for BioInks, glycan engineering, and more
Factory SolutionsEnhancing Factory Solutions “design-and-build” services
IBIO-100Driving development of lead therapeutic asset (IBIO-100)
Intellectual PropertyAggressively defending intellectual property
TalentAdding new talent with a focus upon execution