Exhibit 99.1
| Growing Tomorrow’s Biologics CORPORATE PRESENTATION May 2022 Tom Isett, Chairman & CEO © 2022 iBio, Inc. All Rights Reserved. |
Exhibit 99.1
| Growing Tomorrow’s Biologics CORPORATE PRESENTATION May 2022 Tom Isett, Chairman & CEO © 2022 iBio, Inc. All Rights Reserved. |
| 2 Forward-Looking Statements Certain statements in this presentation constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this presentation. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to obtain regulatory approvals for commercialization of its product candidates, including its COVID-19 vaccines and IBIO-101, or to comply with ongoing regulatory requirements, regulatory limitations relating to its ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of products, its ability to maintain its license agreements, the continued maintenance and growth of its patent estate, its ability to establish and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, competition, its ability to retain its key employees or maintain its NYSE American listing, and the other factors discussed in the Company’s most recent Annual Report on Form 10-K and the Company’s subsequent filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K. The information in this presentation is provided only as of today, and we undertake no obligation to update any forward-looking statements contained in this presentation on account of new information, future events, or otherwise, except as required by law. This presentation shall not constitute an offer to sell, or the solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction. |
| iBio Overview Drug Discovery Platform Novel screening capabilities with AI-driven design FastPharming® Mfg Platform Proprietary plant-based protein expression system Development & Manufacturing Services Delivering speed, scalability, and sustainability Proprietary Pipeline Addressing cancer, fibrosis & infectious diseases 3 |
| 4 Unique Solution for Some of the Industry’s Biggest Problems 1iiBio estimates; 2Belkhir, L., et. al. (2018) “Carbon footprint of the global pharmaceutical industry and relative impact of its major players”. J Cleaner Production 214:185-194 Biopharmaceutical Development Challenges GlycaneeringSM SOLUTIONS Dev/Mfg Services Our Solutions Program Failures Only ~5 in 5,000 drug concepts reach the clinic Time / Cost >1 year & ~$3-7M for scalable bioprocess & Ph1 material1 Biomanufacturing Drug industry is 55% more emissions intensive than the auto industry2 1 2 3 |
| 5 Green Protein Expression System 1 130,000 sf Facility Bacterial Infiltration (Transient Transfection) Protein Production Harvesting Purification & Vialing Seeding & Growth Gene Cloning Mobilization 2 3 4 5 |
| 6 The Speed & Scalability of FastPharming Potentially Enables a Faster, More Efficient Path to the Clinic Time to Drug Substance may vary and does not include product-specific process and assay development work. Mammalian cell culture timelines shown are for illustrative purposes only based upon competitive data from publicly available sources. Actual timelines may vary. brings the capability to avoid the significant cost and time associated with selecting, developing & banking mammalian cell lines Master Cell Bank (Mammalian) Drug Substance Manufacture Drug Substance Manufacture Mammalian Cell Culture Master Cell Bank (Bacterial) months months Candidate Generation |
| CDMO SERVICES Success Rate <5 in 5,000 7 iBio Platform Potentially Enables More Promising Candidates to Reach the Clinic, Faster 1Paul, et al. NatureReviews Drug Discovery. (2010) 9, 203–214 Increased Potency with Glycaneering Industry Benchmarks to Reach IND1 Time >4 Years Cost >$20M Glycaneering Technology + 250 years ~5,000 – 10,000 COMPOUNDS DRUG DISCOVERY PRECLINICAL CLINICAL TRIAL 5 Current Drug Development Challenge 0 40 80 ~79% ADCC ACTIVITY (%) [1.6ng/ml] Glycaneered Rituximab Standard |
| 8 117th Annual Report and Summary of Biopharmaceutical Manufacturing Capacity and Production https://www.biopharma.com/TRENDS.pdf Reducing Single-Use Plastic Disposables in Upstream Processing VS >85% of pre-commercial bioprocesses involve single-use plastic disposables1 Seeds Stone Wool Purified Water The FastPharming Bioreactor uses allnatural raw materials |
| 9 Pipeline Advancing Vertically – and Horizontally |
| Therapeutics Oncology & Fibrosis |
| THERAPEUTICS 11 Deploying AI-based Target ID & Glycaneering in Immuno-Oncology to Create More, Higher-Quality, Shots-on-Goal Access to RubrYc AI Discovery Platform Glycaneering Technology iBio Discovery & More shots-on-goal, Dev Approach 1 sooner Identifying failures 2 earlier, saving costs Accelerating development timelines 3 Pipeline Drug discovery Preclinical Clinical 1 2 3 Traditional BioPharma Pipeline Drug Discovery Preclinical Clinical As programs advance through preclinical testing, iBio has additional opportunities to partner molecules and supply with FastPharming Services |
| THERAPEUTICS IBIO-101 Stimulates Anti-tumor Immunity via anti-CD25 Treg Depletion 12 1Data on file Treg = Regulatory T Cells; Teff = Effector T Cells; ADCC = Antibody Dependent Cellular Cytotoxicity 2nd gen IL-2 sparing anti-CD25 antibody electively targets Tregs without blocking IL-2 signaling to Teffs Positive IBIO-101/RTX-003 preclinical data are consistent with results from one other non-IL2 blocking anti-CD25 antibody that is now in a Phase I clinical trial1 Natural Killer Cell IBIO-101/RTX-003 JAK JAK Teff Tumor Preferential Treg depletion JAK JAK IL-2 Treg IL-2 signaling Proliferation ADCC JAK JAK |
| THERAPEUTICS 13 IBIO-101/RTX-003 Inhibits Tumor Growth, Alone and in Combination 1In vivo xenograft mouse model of lymphoma; Administration: 3x / week, i.p.; n=5 per group 2In vivo transgenic hCD25 mouse model; Admin: i.p. 3X / week at a single dose (1.5 mg/Kg) in combination with 2.5 mg/Kg of anti-mouse PD-1 antibody; n=5/group Greater potency was achieved with afucosylated version of the molecule produced with FastPharming Monotherapy reduced tumor growth in a dose-dependent manner RTX-003 + anti-PD-1 antibody reduced tumor growth and caused regression 0 5 10 15 20 25 0 500 1000 1500 2000 2500 Days Post Engraftment Tumor Size (mm3) PBS D11 3 mg/kg D11 1mg/kg D11 0.3mg/kg PBS (Vehicle) 0.3 mg/kg 1.0 mg/kg 3.0 mg/kg Lymphoma Xenograft Model1 Adenocarcinoma Model2 0 3 6 9 12 15 18 21 24 27 30 33 36 0 1000 2000 3000 4000 Days Post Grouping Tumor volume mm3 PD1 5 mg/kg D11 1.5 + PD1 5 mg/kg PBS D11 1.5 mg/kg PBS (Vehicle) 1.5 mg/kg RTX-003 5.0 mg/kg PD1 mAb 1.5 mg/kg RTX-003 + 5.0 mg/kg PD1 mAb |
| THERAPEUTICS 14 IBIO-101 Has Showed Equivalent Efficacy and Potency with RTX-003 Enabled engineering of more potent version without incremental IP access costs Phan, et al. "Plant-Based Expression and Glyco-Engineering of Novel IL-2 Signaling Permissive Anti-CD25 Antibodies for Effective Treg Depletion in Cancer IBIO-101 binding kinetic profiles are similar in CHO and plant-based expression system RTX-003, CHO WT RTX-003, CHO afuc IBIO-101, Plant afuc Daclizumab Antibody kon (M-1 s-1) koff (s-1) KD (nM) KD SD (nM) IBIO-101-CHO WT 4.71E+05 1.92E-03 4.10 0.37 IBIO-101-CHO afuc 4.99E+05 1.91E-03 3.9 1.03 IBIO-101-Plant WT 4.85E+05 1.96E-03 4.20 0.69 IBIO-101-Plant afuc 4.92E+05 2.07E-03 4.27 1.27 Daclizumab 4.15E+05 7.40E-05 0.18 0.07 IBIO-101, Plant WT Afucosylated IBIO-101 Enhanced ADCC Activity Afucosylated IBIO-101 Elicited Potent Cancer Cells Killing via Human PBMC GlycaneeringSM Potent ADCC with afucosylated plant-made molecule 5000 0 100 00 0 150 00 0 200 00 0 250 00 0 300 00 0 0. 00 1 0 .0 1 0 .1 1 10 1 00 100 0 1000 0 A b (ng/ m l) RLU (Normalized) hIgG Isotype - N/A Daclizumab - EC50 = 137 ng/mL IBIO-101 CHO wt - EC 50 = 137 ng/mL IBIO-101 CHO afuc - EC 50 = 7.2 ng/mL IBIO-101 Plant wt - EC 50 = 32.5 ng/mL IBIO-101 Plant afuc - EC50 = 11.2 ng/mL 0 .0 1 0 .1 1 15 20 25 30 35 40 45 10 1 00 100 0 1000 0 A b (ng/m l) % Cytotoxicity hIgG isotype IBIO-101 CHO afuc - EC50 = 1.69 ng/mL IBIO-101 Plant afuc - EC 50 = 1.57 ng/mL |
| THERAPEUTICS 15 Endostatin Derived Drugs for Fibrotic Disorders and Fibrotic Tumors Endostatin E4 for Fibrotic Tumors Reduces fibrosis by impacting extracellular matrices1 Pre-clinical data shows reduced fibrosis in scleroderma/IPF models & human lung explants1 IBIO-100 Orphan Drug Designation for systemic scleroderma received Fibrotic Tissue 100μg IBIO-100 3x/week Bleomycin Pre-Clinical Model2 Cancer-associated fibroblasts [CAFs] are one of the most abundant and critical components of tumor tissue: • Can promote or retard tumorigenesis in a contextdependent manner • Recent studies have revealed their roles in immune evasion and poor responses to cancer immunotherapy2 • Response to chemotherapy is highly variable3 1 Data on file 2 Liu, T., Han, C., Wang, S. et al. Cancer-associated fibroblasts: an emerging target of anti-cancer immunotherapy. J Hematol Oncol 12, 86 (2019). https://doi.org/10.1186/s13045-019-0770-1 3 Sonnenberg, M., van der Kuip, H., Haubeiß, S. et al. Highly variable response to cytotoxic chemotherapy in carcinoma-associated fibroblasts (CAFs) from lung and breast. BMC Cancer 8, 364 (2008). https://doi.org/10.1186/1471-2407-8-364 |
| Vaccines Human Health: COVID-19 Animal Health: CSFV |
| VACCINES 17 Experts Calling for Approaches Like iBio’s “DAVi” Vaccine Design 1 Borio, Bright, and Emanuel, A National Strategy for COVID-19 Medical Countermeasures, JAMA. 2022;327(3):215–216 We need to work towards a 'last dose', not a 'next dose' Antigen-adjuvant combos that may deliver long-lasting immunity Lower cost vaccines & alternative routes of administration Less mutable antigens to protect against emerging variants IBIO-202 Durability Variantinclusion Access “Vaccination strategies based on repeated booster doses of the original vaccine composition are unlikely to be appropriate or sustainable." Boosters are “not something that should be repeated constantly”…it could lead to "problems with immune response." |
| VACCINES 18 IBIO-202 Nucleocapsid [N]-based Subunit Vaccine May Complement Current and Future Spike [S]-based Vaccines 1 Dai, L. & Gao, G. F. Viral targets for vaccines against COVID-19. Nature Reviews Immunology 21, 73–82 (2021); 2 Fielding CA, et.al., ADNKA overcomes SARS-CoV2-mediated NK cell inhibition through non-spike antibodies. bioRxiv, (April 2021) Antigen produced in our rapidly scalable FastPharming System N-antigen more effective than S in stimulating Natural Killer cell activation2 Prospectively suitable for delivery via routes other than intramuscular injection N protein function is critical to viral genome packaging and is more highly conserved than the S protein. Thus, new viral variants may be less likely to escape N-based vaccines1 |
| VACCINES IBIO-202 Preclinical Data Shows Potential for Protective Humoral 19 & Cell-mediated Immune Responses Ctrl. IBIO-202 0 1 2 3 4 IFN-g Secreting cells/106 ✱✱✱✱ High number of N-specific IFNg secreting T cells indicates immune activation Ctrl. IBIO-202 0 1 2 3 4 IL-5 Secreting cells/106 ns Ctrl. IBIO-202 0 1 2 3 4 IL-13 Secreting cells/106 ns Low number of IL-5 & IL-13 secreting cells indicates T-cell priming Better Immune Response Increasing Antibody Titer 1/100 1/6400 no adjuvant poor adjuvant Selected, optimal adjuvant Increasing Blood Dilution Adjuvanted IBIO-202 causes strong anti-N titers IBIO-202 desired Th1 skew indicative of a protective, not inflammatory, immune response Ctrl. Adjuv. 2 Poor Adjuvant IgG1 (Th2 response) IgG2C (desired Th1 response) Selected, optimal Adjuvant Adjuv. 1 Antibody Response T-cell Response iBio data on file |
| VACCINES 20 Emerging Studies Reinforce Value of IBIO-202’s Design 1Kundu, R., Narean, J.S., Wang, L. et al. Cross-reactive memory T cells associate with protection against SARS-CoV-2 infection in COVID-19 contacts. Nat Commun 13, 80 (2022) 2Cohen, et al. Cell Reports Medicine. July 2021 Potential for a pan-betacoronavirus vaccine strengthening Nucleocapsid-based induction of mature T cells adds benefit to more rapid containment of infection as variants overtake the prevailing strains2 Our antigen has an epitope predicted to provide cross-protection to other betacoronaviruses “N-, not S-, reactive T cells play a protective role”1 IgG Antibodies to Other Human Coronaviruses COVID-19+ Pre-pandemic Time Months 8 Immune Response Beta CoV SARS-CoV-1 Alpha CoV 254 COVID-19+ patients 760 sampling visits SARS-CoV-2 Specificities CD4 T Cell CD8 T Cell Spike 1 Spike 2 Env & Membrane Nucleocapsid ORF 3a, 6 ORF 7a, 7b, 8 |
| VACCINES 9 4 2 1 N only (US & global companies) ■ N only (academic, government, ex-US) ■S+N+M or other combination ■S+N 21 IBIO-202 Appears Differentiated in a Crowded Field 1Dangi, Tanushree et al. “Combining spike- and nucleocapsid-based vaccines improves distal control of SARS-CoV-2.” Cell reports vol. 36,10 (2021) • N-directed vaccines may provide protection from COVID’s neurological effects that S vaccines may not1 • Simpler N-only design could improve access with lower COGS • Potential pan-betacoronavirus effects could obviate the need for spike antigen vaccination 169 16 Spike Only Nucleocapsid Source: GlobalData database of drugs in development by targeted antigen |
| Classical Swine Fever Animal Health |
| VACCINES 23 Classical Swine Fever [CSF] is a Significant World-Wide Economic Burden and Puts Major Export Markets at Risk • CSF is a priority agricultural biothreat • CSF poses a risk to $7.0B US swine exports • Only 38 countries are currently CSF-free • No vaccines are approved in the US (only a few for emergency use) • Current emergency use CSF vaccines have drawbacks Vaccination control programs are essential to manage outbreaks and regain trade status https://www.oie.int/en/disease/classical-swine-fever/#ui-id-2 o Modified live vaccines do not facilitate international trade o Recombinant vaccines can be expensive |
| VACCINES 24 IBIO-400 Offers Potential Benefits Over Current Alternatives 1 In studies IBIO-400: E2 protein subunit vaccine CSF Virus Provides single-dose protection against CSF1 Supports important trade requirements, unlike live virus vaccines Potential to be the first CSF vaccine fully licensed by USDA A single dose of IBIO-400 provides protection for pigs |
| In Summary |
| Our Leadership Team Brings Drug Development & Bioprocessing Experience 26 Tom Isett CEO & Chairman Martin Brenner, DVM, Ph.D. CSO Robert Lutz, MBA CFBO Lisa Middlebrook CHRO Marc Banjak GC |
| 27 Strong and Growing IP Estate Provides Exclusivity for iBio’s Pipeline Issued Patents (30 U.S.) 104 Active Applications (10 U.S.) 29 More Applications progressing to filing Patent Protection Includes: • IP for iBio’s pipeline products and vaccines • IP related to the FastPharming Protein Expression System • Elements of Glycaneering Service for advanced glycosylation controls in plants, including afucosylation for Antibody-Dependent Cellular Cytotoxicity [ADCC] Continuing to Aggressively Defend our Intellectual Property • Settled iBio v. Fraunhofer USA for $28M in May 2021 |
| 28 Financial Overview § Publicly traded (NYSEA: IBIO) since Jan 2008 § Approximately $48.6M in cash and cash equivalents plus investments in debt securities, excluding $5.9M of restricted cash (31 Mar 2022) § Approximately 218.2M common shares & 17.1M options, restricted stock units and warrants outstanding (31 Mar 2022) § Texas Manufacturing Facility § Purchased in Nov 2021 with approximately $22.4M debt (secured by the facility), $6M in cash, and 1.3M warrants § Evaluating sale-leaseback to extinguish debt and recover cash § Current cash provides runway through Sept 30, 2023 |
| 29 iBio: Leveraging Capabilities to Create Shareholder Value Providing better options for the $6B Bioprocess industry Leveraging platform for both in-licensing and out-licensing with captured supply agreements Selectively out-licensing assets and securing FastPharming supply contracts Advancing our proprietary pipeline of vaccines and therapeutics with FastPharming Manufacturing CDMO Services Proprietary Pipeline Partnering |
