ENABLING NEXT-GEN BIOLOGICS...2020/03/16  · Robert B. Kay Co-Chairman •Accomplished business...

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ENABLING NEXT-GEN BIOLOGICS CORPORATE PRESENTATION Tom Isett, Co-Chairman and CEO

Transcript of ENABLING NEXT-GEN BIOLOGICS...2020/03/16  · Robert B. Kay Co-Chairman •Accomplished business...

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ENABLING NEXT-GENBIOLOGICSCORPORATE PRESENTATIONTom Isett, Co-Chairman and CEO

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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

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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

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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

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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

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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

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“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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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Investor RelationsSteve Kilmer+1 (646) [email protected]

Contact

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