8-K
iBio, Inc. (IBIO)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): May 13, 2022
iBio, Inc.
(Exact name of registrant as specified in charter)
Delaware
(State or other jurisdiction of incorporation)
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| 001-35023 | 26-2797813 |
| (Commission File Number) | (IRS Employer Identification No.) |
8800 HSC Parkway
Bryan , Texas **** 77807
(Address of principal executive offices and zip code)
( 979 ) 446-0027
(Registrant’s telephone number including area code)
N/A
(Former Name and Former Address)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions:
☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12)
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, $0.001 par value per share | IBIO | NYSE American |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01. Regulation FD Disclosure.
iBio, Inc. (the “Company”) has updated its corporate presentation. A copy of the updated corporate presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 and in the corporate presentation attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01 and in the corporate presentation attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
The corporate presentation attached as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.
The Company undertakes no duty or obligation to update or revise the information contained in this Current Report on Form 8-K, although it may do so from time to time if its management believes it is appropriate. Any such updating may be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases or through other public disclosures.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit 99.1 is furnished with this Current Report on Form 8-K.
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| Exhibit<br>Number | Exhibit Description | |
| 99.1 | | Corporate Presentation of iBio, Inc. dated May 2022 |
| 104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: May 13, 2022 | IBIO, INC. | ||
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| By: | /s/ Thomas F. Isett | ||
| Name: | Thomas F. Isett | ||
| Title: | Chief Executive Officer |
Exhibit 99.1
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Growing Tomorrow’s<br><br>Biologics<br><br>CORPORATE PRESENTATION<br><br>May 2022<br><br>Tom Isett, Chairman & CEO<br><br>© 2022 iBio, Inc. All Rights Reserved. |
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2<br><br>Forward-Looking Statements<br><br>Certain statements in this presentation constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as<br><br>amended. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend"<br><br>or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are<br><br>based upon current estimates. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any<br><br>such forward-looking statements, which are based on information available to us on the date of this presentation. These forward-looking statements are<br><br>subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations<br><br>and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from<br><br>current expectations include, among others, the Company’s ability to obtain regulatory approvals for commercialization of its product candidates,<br><br>including its COVID-19 vaccines and IBIO-101, or to comply with ongoing regulatory requirements, regulatory limitations relating to its ability to promote or<br><br>commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development,<br><br>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<br><br>and maintain collaborations, its ability to obtain or maintain the capital or grants necessary to fund its research and development activities, competition, its<br><br>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<br><br>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<br><br>presentation is provided only as of today, and we undertake no obligation to update any forward-looking statements contained in this presentation on<br><br>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<br><br>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<br><br>the registration or qualification under the securities laws of such state or jurisdiction. |
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iBio Overview<br><br>Drug Discovery Platform<br><br>Novel screening capabilities<br><br>with AI-driven design<br><br>FastPharming® Mfg<br><br>Platform<br><br>Proprietary plant-based protein<br><br>expression system<br><br>Development &<br><br>Manufacturing Services<br><br>Delivering speed, scalability, and<br><br>sustainability<br><br>Proprietary Pipeline<br><br>Addressing cancer, fibrosis<br><br>& infectious diseases<br><br>3 |
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4<br><br>Unique Solution for Some of the Industry’s Biggest Problems<br><br>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<br><br>Biopharmaceutical Development Challenges<br><br>GlycaneeringSM<br><br>SOLUTIONS<br><br>Dev/Mfg Services<br><br>Our Solutions<br><br>Program Failures<br><br>Only ~5 in 5,000 drug<br><br>concepts reach the<br><br>clinic<br><br>Time / Cost<br><br>>1 year & ~$3-7M for<br><br>scalable bioprocess &<br><br>Ph1 material1<br><br>Biomanufacturing<br><br>Drug industry is 55%<br><br>more emissions intensive<br><br>than the auto industry2<br><br>1 2 3 |
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5<br><br>Green Protein Expression System<br><br>1 130,000 sf Facility<br><br>Bacterial Infiltration<br><br>(Transient Transfection)<br><br>Protein<br><br>Production<br><br>Harvesting Purification<br><br>& Vialing<br><br>Seeding & Growth<br><br>Gene Cloning Mobilization<br><br>2 3 4 5 |
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6 The Speed & Scalability of FastPharming Potentially Enables a Faster,<br><br>More Efficient Path to the Clinic<br><br>Time to Drug Substance may vary and does not include product-specific process and assay development work.<br><br>Mammalian cell culture timelines shown are for illustrative purposes only based upon competitive data from publicly available sources. Actual timelines may vary.<br><br>brings the capability to avoid the significant cost and time<br><br>associated with selecting, developing & banking mammalian cell lines<br><br>Master<br><br>Cell Bank<br><br>(Mammalian) Drug Substance<br><br>Manufacture<br><br>Drug Substance<br><br>Manufacture<br><br>Mammalian<br><br>Cell Culture<br><br>Master<br><br>Cell Bank<br><br>(Bacterial)<br><br>months months<br><br>Candidate<br><br>Generation |
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CDMO SERVICES<br><br>Success Rate<br><br><5 in 5,000<br><br>7 iBio Platform Potentially Enables More Promising Candidates to Reach<br><br>the Clinic, Faster<br><br>1Paul, et al. NatureReviews Drug Discovery. (2010) 9, 203–214<br><br>Increased Potency with Glycaneering<br><br>Industry Benchmarks to Reach IND1<br><br>Time<br><br>>4 Years<br><br>Cost<br><br>>$20M<br><br>Glycaneering Technology<br><br>+<br><br>250<br><br>years<br><br>~5,000 –<br><br>10,000<br><br>COMPOUNDS<br><br>DRUG DISCOVERY PRECLINICAL CLINICAL TRIAL<br><br>5<br><br>Current Drug Development Challenge<br><br>0<br><br>40<br><br>80<br><br>~79%<br><br>ADCC ACTIVITY (%)<br><br>[1.6ng/ml]<br><br>Glycaneered Rituximab<br><br>Standard |
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8<br><br>117th Annual Report and Summary of Biopharmaceutical Manufacturing Capacity and Production https://www.biopharma.com/TRENDS.pdf<br><br>Reducing Single-Use Plastic Disposables in Upstream Processing<br><br>VS<br><br>>85% of pre-commercial<br><br>bioprocesses involve<br><br>single-use plastic disposables1<br><br>Seeds Stone Wool Purified Water<br><br>The FastPharming<br><br>Bioreactor uses allnatural<br><br>raw materials |
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9<br><br>Pipeline Advancing Vertically – and Horizontally |
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Therapeutics<br><br>Oncology & Fibrosis |
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THERAPEUTICS<br><br>11 Deploying AI-based Target ID & Glycaneering in Immuno-Oncology<br><br>to Create More, Higher-Quality, Shots-on-Goal<br><br>Access to RubrYc AI<br><br>Discovery Platform<br><br>Glycaneering<br><br>Technology<br><br>iBio Discovery &<br><br>More shots-on-goal, Dev Approach<br><br>1 sooner<br><br>Identifying failures<br><br>2 earlier, saving costs<br><br>Accelerating<br><br>development<br><br>timelines<br><br>3<br><br>Pipeline<br><br>Drug<br><br>discovery<br><br>Preclinical<br><br>Clinical<br><br>1 2 3<br><br>Traditional BioPharma Pipeline<br><br>Drug<br><br>Discovery Preclinical Clinical<br><br>As programs advance through<br><br>preclinical testing, iBio has<br><br>additional opportunities to<br><br>partner molecules and supply<br><br>with FastPharming Services |
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THERAPEUTICS<br><br>IBIO-101 Stimulates Anti-tumor Immunity via anti-CD25 Treg Depletion<br><br>12<br><br>1Data on file<br><br>Treg = Regulatory T Cells; Teff = Effector T Cells; ADCC = Antibody Dependent Cellular Cytotoxicity<br><br>2nd gen IL-2 sparing anti-CD25 antibody electively targets Tregs without blocking IL-2 signaling to Teffs<br><br>Positive IBIO-101/RTX-003 preclinical data are consistent with results from one other non-IL2 blocking<br><br>anti-CD25 antibody that is now in a Phase I clinical trial1<br><br>Natural Killer Cell<br><br>IBIO-101/RTX-003<br><br>JAK JAK Teff Tumor<br><br>Preferential Treg depletion<br><br>JAK JAK<br><br>IL-2<br><br>Treg<br><br>IL-2 signaling<br><br>Proliferation<br><br>ADCC<br><br>JAK JAK |
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THERAPEUTICS<br><br>13<br><br>IBIO-101/RTX-003 Inhibits Tumor Growth, Alone and in Combination<br><br>1In vivo xenograft mouse model of lymphoma; Administration: 3x / week, i.p.; n=5 per group<br><br>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<br><br>Greater potency was achieved with afucosylated version of the molecule produced with FastPharming<br><br>Monotherapy reduced tumor growth<br><br>in a dose-dependent manner<br><br>RTX-003 + anti-PD-1 antibody reduced<br><br>tumor growth and caused regression<br><br>0 5 10 15 20 25<br><br>0<br><br>500<br><br>1000<br><br>1500<br><br>2000<br><br>2500<br><br>Days Post Engraftment<br><br>Tumor Size (mm3)<br><br>PBS<br><br>D11 3 mg/kg<br><br>D11 1mg/kg<br><br>D11 0.3mg/kg<br><br>PBS (Vehicle)<br><br>0.3 mg/kg<br><br>1.0 mg/kg<br><br>3.0 mg/kg<br><br>Lymphoma Xenograft Model1 Adenocarcinoma Model2<br><br>0 3 6 9 12 15 18 21 24 27 30 33 36<br><br>0<br><br>1000<br><br>2000<br><br>3000<br><br>4000<br><br>Days Post Grouping<br><br>Tumor volume mm3<br><br>PD1 5 mg/kg<br><br>D11 1.5 + PD1 5 mg/kg<br><br>PBS<br><br>D11 1.5 mg/kg<br><br>PBS (Vehicle)<br><br>1.5 mg/kg RTX-003<br><br>5.0 mg/kg PD1 mAb<br><br>1.5 mg/kg RTX-003 +<br><br>5.0 mg/kg PD1 mAb |
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THERAPEUTICS<br><br>14<br><br>IBIO-101 Has Showed Equivalent Efficacy and Potency with RTX-003<br><br>Enabled engineering of more potent version<br><br>without incremental IP access costs<br><br>Phan, et al. "Plant-Based Expression and Glyco-Engineering of Novel IL-2 Signaling Permissive Anti-CD25 Antibodies for Effective Treg Depletion in Cancer<br><br>IBIO-101 binding kinetic profiles are similar in<br><br>CHO and plant-based expression system<br><br>RTX-003, CHO WT<br><br>RTX-003, CHO afuc IBIO-101, Plant afuc<br><br>Daclizumab<br><br>Antibody kon (M-1 s-1) koff (s-1) KD (nM) KD SD (nM)<br><br>IBIO-101-CHO WT 4.71E+05 1.92E-03 4.10 0.37<br><br>IBIO-101-CHO afuc 4.99E+05 1.91E-03 3.9 1.03<br><br>IBIO-101-Plant WT 4.85E+05 1.96E-03 4.20 0.69<br><br>IBIO-101-Plant afuc 4.92E+05 2.07E-03 4.27 1.27<br><br>Daclizumab 4.15E+05 7.40E-05 0.18 0.07<br><br>IBIO-101, Plant WT Afucosylated IBIO-101 Enhanced ADCC Activity<br><br>Afucosylated IBIO-101 Elicited Potent Cancer<br><br>Cells Killing via Human PBMC<br><br>GlycaneeringSM<br><br>Potent ADCC with afucosylated plant-made molecule<br><br>5000 0<br><br>100 00 0<br><br>150 00 0<br><br>200 00 0<br><br>250 00 0<br><br>300 00 0<br><br>0. 00 1 0 .0 1 0 .1 1 10 1 00 100 0 1000 0<br><br>A b (ng/ m l)<br><br>RLU (Normalized)<br><br>hIgG Isotype - N/A<br><br>Daclizumab - EC50 = 137 ng/mL<br><br>IBIO-101 CHO wt - EC 50 = 137 ng/mL<br><br>IBIO-101 CHO afuc - EC 50 = 7.2 ng/mL<br><br>IBIO-101 Plant wt - EC 50 = 32.5 ng/mL<br><br>IBIO-101 Plant afuc - EC50 = 11.2 ng/mL<br><br>0 .0 1 0 .1 1<br><br>15<br><br>20<br><br>25<br><br>30<br><br>35<br><br>40<br><br>45<br><br>10 1 00 100 0 1000 0<br><br>A b (ng/m l)<br><br>% Cytotoxicity<br><br>hIgG isotype<br><br>IBIO-101 CHO afuc - EC50 = 1.69 ng/mL<br><br>IBIO-101 Plant afuc - EC 50 = 1.57 ng/mL |
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THERAPEUTICS<br><br>15<br><br>Endostatin Derived Drugs for Fibrotic Disorders and Fibrotic Tumors<br><br>Endostatin E4 for Fibrotic Tumors<br><br>Reduces fibrosis by impacting extracellular matrices1<br><br>Pre-clinical data shows reduced fibrosis in<br><br>scleroderma/IPF models & human lung explants1<br><br>IBIO-100<br><br>Orphan Drug Designation for systemic scleroderma received<br><br>Fibrotic Tissue 100μg IBIO-100 3x/week<br><br>Bleomycin Pre-Clinical Model2<br><br>Cancer-associated fibroblasts [CAFs] are one of the most<br><br>abundant and critical components of tumor tissue:<br><br>• Can promote or retard tumorigenesis in a contextdependent<br><br>manner<br><br>• Recent studies have revealed their roles in immune<br><br>evasion and poor responses to cancer<br><br>immunotherapy2<br><br>• Response to chemotherapy is highly variable3<br><br>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<br><br>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 |
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Vaccines<br><br>Human Health: COVID-19<br><br>Animal Health: CSFV |
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VACCINES<br><br>17<br><br>Experts Calling for Approaches Like iBio’s “DAVi” Vaccine Design<br><br>1 Borio, Bright, and Emanuel, A National Strategy for COVID-19 Medical Countermeasures, JAMA. 2022;327(3):215–216<br><br>We need to work towards a 'last dose', not a 'next dose'<br><br>Antigen-adjuvant combos that<br><br>may deliver long-lasting immunity<br><br>Lower cost vaccines &<br><br>alternative routes of<br><br>administration<br><br>Less mutable antigens<br><br>to protect against<br><br>emerging variants<br><br>IBIO-202<br><br>Durability<br><br>Variantinclusion<br><br>Access<br><br>“Vaccination strategies based on<br><br>repeated booster doses of the original<br><br>vaccine composition are unlikely to be<br><br>appropriate or sustainable."<br><br>Boosters are “not something that should<br><br>be repeated constantly”…it could lead<br><br>to "problems with immune response." |
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VACCINES<br><br>18 IBIO-202 Nucleocapsid [N]-based Subunit Vaccine May Complement<br><br>Current and Future Spike [S]-based Vaccines<br><br>1 Dai, L. & Gao, G. F. Viral targets for vaccines against COVID-19. Nature Reviews Immunology 21, 73–82 (2021);<br><br>2 Fielding CA, et.al., ADNKA overcomes SARS-CoV2-mediated NK cell inhibition through non-spike antibodies. bioRxiv, (April 2021)<br><br>Antigen produced in our rapidly scalable<br><br>FastPharming System<br><br>N-antigen more effective than S in stimulating<br><br>Natural Killer cell activation2<br><br>Prospectively suitable for delivery via routes<br><br>other than intramuscular injection<br><br>N protein function is critical to viral genome<br><br>packaging and is more highly conserved than<br><br>the S protein. Thus, new viral variants may be<br><br>less likely to escape N-based vaccines1 |
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VACCINES<br><br>IBIO-202 Preclinical Data Shows Potential for Protective Humoral 19<br><br>& Cell-mediated Immune Responses<br><br>Ctrl. IBIO-202<br><br>0<br><br>1<br><br>2<br><br>3<br><br>4<br><br>IFN-g Secreting cells/106<br><br>✱✱✱✱<br><br>High number of N-specific IFNg secreting T<br><br>cells indicates immune activation<br><br>Ctrl. IBIO-202<br><br>0<br><br>1<br><br>2<br><br>3<br><br>4<br><br>IL-5 Secreting cells/106<br><br>ns<br><br>Ctrl. IBIO-202<br><br>0<br><br>1<br><br>2<br><br>3<br><br>4<br><br>IL-13 Secreting cells/106<br><br>ns<br><br>Low number of IL-5 & IL-13 secreting<br><br>cells indicates T-cell priming<br><br>Better Immune<br><br>Response<br><br>Increasing Antibody Titer<br><br>1/100 1/6400<br><br>no adjuvant<br><br>poor adjuvant<br><br>Selected, optimal<br><br>adjuvant<br><br>Increasing Blood Dilution<br><br>Adjuvanted IBIO-202<br><br>causes strong anti-N titers<br><br>IBIO-202 desired Th1 skew indicative of a<br><br>protective, not inflammatory, immune response<br><br>Ctrl. Adjuv. 2<br><br>Poor<br><br>Adjuvant<br><br>IgG1 (Th2 response)<br><br>IgG2C (desired Th1 response)<br><br>Selected, optimal<br><br>Adjuvant<br><br>Adjuv. 1<br><br>Antibody<br><br>Response<br><br>T-cell<br><br>Response<br><br>iBio data on file |
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VACCINES<br><br>20<br><br>Emerging Studies Reinforce Value of IBIO-202’s Design<br><br>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)<br><br>2Cohen, et al. Cell Reports Medicine. July 2021<br><br>Potential for a pan-betacoronavirus vaccine strengthening<br><br>Nucleocapsid-based induction of mature T cells<br><br>adds benefit to more rapid containment of infection<br><br>as variants overtake the prevailing strains2<br><br>Our antigen has an epitope predicted to<br><br>provide cross-protection to other<br><br>betacoronaviruses<br><br>“N-, not S-, reactive T cells<br><br>play a protective role”1<br><br>IgG Antibodies to Other<br><br>Human Coronaviruses<br><br>COVID-19+ Pre-pandemic<br><br>Time<br><br>Months<br><br>8<br><br>Immune Response<br><br>Beta CoV<br><br>SARS-CoV-1<br><br>Alpha CoV<br><br>254 COVID-19+ patients<br><br>760 sampling visits<br><br>SARS-CoV-2 Specificities<br><br>CD4 T Cell CD8 T Cell<br><br>Spike 1<br><br>Spike 2<br><br>Env & Membrane<br><br>Nucleocapsid<br><br>ORF 3a, 6<br><br>ORF 7a, 7b, 8 |
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VACCINES<br><br>9<br><br>4<br><br>2<br><br>1<br><br>N only (US & global companies)<br><br>■ N only (academic, government, ex-US)<br><br>■S+N+M or other combination<br><br>■S+N<br><br>21<br><br>IBIO-202 Appears Differentiated in a Crowded Field<br><br>1Dangi, Tanushree et al. “Combining spike- and nucleocapsid-based vaccines improves distal control of SARS-CoV-2.” Cell reports vol. 36,10 (2021)<br><br>• N-directed vaccines may provide<br><br>protection from COVID’s neurological<br><br>effects that S vaccines may not1<br><br>• Simpler N-only design could improve<br><br>access with lower COGS<br><br>• Potential pan-betacoronavirus effects<br><br>could obviate the need for spike<br><br>antigen vaccination<br><br>169<br><br>16<br><br>Spike Only Nucleocapsid<br><br>Source: GlobalData database of drugs in<br><br>development by targeted antigen |
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Classical Swine Fever<br><br>Animal Health |
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VACCINES<br><br>23 Classical Swine Fever [CSF] is a Significant World-Wide Economic<br><br>Burden and Puts Major Export Markets at Risk<br><br>• CSF is a priority agricultural biothreat<br><br>• CSF poses a risk to $7.0B US swine exports<br><br>• Only 38 countries are currently CSF-free<br><br>• No vaccines are approved in the US (only a few<br><br>for emergency use)<br><br>• Current emergency use CSF vaccines have<br><br>drawbacks<br><br>Vaccination control programs are essential to manage outbreaks and regain trade status<br><br>https://www.oie.int/en/disease/classical-swine-fever/#ui-id-2<br><br>o Modified live vaccines do not facilitate international trade<br><br>o Recombinant vaccines can be expensive |
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VACCINES<br><br>24<br><br>IBIO-400 Offers Potential Benefits Over Current Alternatives<br><br>1 In studies<br><br>IBIO-400: E2 protein<br><br>subunit vaccine<br><br>CSF<br><br>Virus<br><br>Provides single-dose protection<br><br>against CSF1<br><br>Supports important trade<br><br>requirements, unlike live virus vaccines<br><br>Potential to be the first CSF vaccine<br><br>fully licensed by USDA<br><br>A single dose of IBIO-400<br><br>provides protection for pigs |
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In Summary |
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Our Leadership Team Brings Drug Development & Bioprocessing Experience<br><br>26<br><br>Tom Isett<br><br>CEO & Chairman<br><br>Martin Brenner, DVM, Ph.D.<br><br>CSO<br><br>Robert Lutz, MBA<br><br>CFBO<br><br>Lisa Middlebrook<br><br>CHRO<br><br>Marc Banjak<br><br>GC |
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27<br><br>Strong and Growing IP Estate Provides Exclusivity for iBio’s Pipeline<br><br>Issued Patents<br><br>(30 U.S.)<br><br>104 Active Applications<br><br>(10 U.S.)<br><br>29 More<br><br>Applications<br><br>progressing to filing<br><br>Patent Protection Includes:<br><br>• IP for iBio’s pipeline products and vaccines<br><br>• IP related to the FastPharming Protein Expression System<br><br>• Elements of Glycaneering Service for advanced glycosylation controls in plants,<br><br>including afucosylation for Antibody-Dependent Cellular Cytotoxicity [ADCC]<br><br>Continuing to Aggressively Defend our Intellectual Property<br><br>• Settled iBio v. Fraunhofer USA for $28M in May 2021 |
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28<br><br>Financial Overview<br><br>§ Publicly traded (NYSEA: IBIO) since Jan 2008<br><br>§ Approximately $48.6M in cash and cash equivalents<br><br>plus investments in debt securities, excluding $5.9M of<br><br>restricted cash (31 Mar 2022)<br><br>§ Approximately 218.2M common shares & 17.1M<br><br>options, restricted stock units and warrants outstanding<br><br>(31 Mar 2022)<br><br>§ Texas Manufacturing Facility<br><br>§ Purchased in Nov 2021 with approximately $22.4M debt<br><br>(secured by the facility), $6M in cash, and 1.3M warrants<br><br>§ Evaluating sale-leaseback to extinguish debt and<br><br>recover cash<br><br>§ Current cash provides runway through Sept 30, 2023 |
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29<br><br>iBio: Leveraging Capabilities to Create Shareholder Value<br><br>Providing better options for<br><br>the $6B Bioprocess industry<br><br>Leveraging platform for both<br><br>in-licensing and out-licensing with<br><br>captured supply agreements<br><br>Selectively out-licensing assets and<br><br>securing FastPharming supply contracts<br><br>Advancing our proprietary<br><br>pipeline of vaccines and<br><br>therapeutics with<br><br>FastPharming Manufacturing<br><br>CDMO<br><br>Services<br><br>Proprietary<br><br>Pipeline<br><br>Partnering |




























