8-K

iBio, Inc. (IBIO)

8-K 2023-04-24 For: 2023-04-24
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Added on April 07, 2026

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): April 24, 2023

iBio, Inc.

(Exact name of registrant as specified in charter)

Delaware

(State or other jurisdiction of incorporation)

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:

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.

Exhibit<br>Number Exhibit Description
99.1 Corporate Presentation of iBio, Inc. dated April 2023

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: April 24, 2023 IBIO, INC.
By: /s/ Marc A. Banjak
Name: Marc A. Banjak
Title: General Counsel and Corporate Secretary

Exhibit 99.1

April 2023
Forward-looking Statements<br>Certain statements in this presentation constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as<br>amended. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend"<br>or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are<br>based upon current estimates. While iBio, Inc., a Delaware corporation (including its consolidated subsidiaries, “iBio,” the “Company,” “we,” “us” or “our”)<br>believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based<br>on information available to us on the date of this presentation. These forward-looking statements are subject to various risks and uncertainties, many of<br>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<br>any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the<br>Company’s ability to obtain regulatory approvals for commercialization of its product candidates, or to comply with ongoing regulatory requirements,<br>regulatory limitations relating to its ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates<br>in the marketplace and the successful development, marketing or sale of products, its ability to attain license agreements, the continued maintenance and<br>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<br>research and development activities, competition, its ability to retain its key employees or maintain its NYSE American listing, and the other factors discussed<br>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<br>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<br>statements contained in this presentation on account of new information, future events, or otherwise, except as required by law. This presentation, and any<br>oral statements made in connection with this presentation, shall not constitute an offer to sell, or the solicitation of an offer to buy, or a recommendation to<br>purchase any equity, debt or other securities of the Company, nor, in connection with any securities offering by the Company, will there be any sale of<br>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<br>securities laws of such state or jurisdiction.<br>2
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EXECUTIVE SUMMARY<br>iBio’s technology stack<br>delivers precision antibodies<br>designed to minimize<br>downstream development<br>risk through AI-guided<br>epitope-steering and mAb<br>optimization<br>Patented* epitope-steering AI engine allows us to<br>target specific regions of proteins<br>The Ab-optimizing StableHu™ AI-Engine coupled with<br>mammalian display technology speeds up Lead<br>Optimization; potentially minimizes downstream risks<br>Team of experienced AI/ML scientists and drug<br>hunters have the skills and capabilities to quickly<br>advance antibodies from concept to in vivo POC<br>Lead molecules are comparable to “hard-to-engineer”<br>antibodies that were licensed or acquired with<br>upfronts ranging from $35-85M and total deal values<br>>$500M at similar stages of development<br>* U.S. Patent No. 11,545,238 3
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Antibody Engineering is Hard: iBio’s Precision AI Technology Provides<br>4<br>Solutions<br>Antibodies are built from stretches of amino acids, which are the words and<br>sentences that make up the natural language of biology. We are using AI to<br>decipher that language with a goal to explore novel biology and create<br>immunotherapies directed toward hard-to-drug targets.<br>AI-powered precision-targeting GEN<br>3<br>Greater developability<br>GEN<br>2<br>Enabling next-gen formats<br>GEN<br>1
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AI Tech Stack Yields Precision-Targeted Antibodies with Lower Downstream Risk<br>*U.S. Patent No. 11,545,238 (issued January 3, 2023) 5<br>Epitope Engineering<br>Engine<br>• Patented* epitope engineering<br>• AI-engineered epitope maintains<br>target structure<br>Proprietary Antibody<br>Library<br>3<br>StableHu™<br>Antibody Optimizer<br>• Human antibody diversity<br>• Clinically validated frameworks<br>• Benchmarked vs. competitive libraries<br>• Mammalian-display library enriched<br>with functional antibodies<br>• Human sequence and optimization<br>faster than traditional methods<br>Multiple validations<br>with difficult targets<br>and MoAs<br>1<br>2
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Our Discovery Engine in Action<br>*U.S. Patent No. 11,545,238 (issued January 3, 2023) 6<br>1<br>AI-powered precision<br>targeting of<br>conformational &<br>sub-dominant epitopes<br>Epitope-specific<br>antigens built to<br>efficiently & selectively<br>discover antibodies<br>AI-generated naïve<br>antibody library, free<br>of sequence liabilities<br>AI-powered<br>sequence<br>optimization to<br>improve performance<br>Optimized Leads<br>evaluated & ranked<br>in translational<br>disease models<br>Epitope Engineering<br>Engine*<br>Engineered<br>Epitope<br>Proprietary Human<br>mAb Library<br>StableHu™ Antibody<br>Optimizer<br>Optimized mAb<br>Lead Pool On-Epitope<br>Clinical Candidate<br>2 3 4 5
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Therapeutics Pipeline Growth and Maturation Driven Primarily by Cancer<br>7<br>Autoimmune PD-1 Autoimmune Disease s<br>Solid Tumors<br>Solid Tumors<br>Immuno-Oncology<br>Immuno-Oncology<br>Immuno-Oncology<br>Immuno-Oncology<br>Immuno-Oncology<br>Immuno-Oncology<br>Immuno-Oncology<br>Oncology<br>OPTIMIZATION<br>Immunotherapies<br>PROGRAMS EARLY DISCOVERY LATE DISCOVERY<br>IBIO-101<br>Endostatin E4<br>Target 3<br>MUC16<br>Target 5<br>EGFRvIII<br>CCR8<br>Target 8<br>CD3<br>LEAD IND-ENABLING CLINICAL
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We Believe Our AI Platform Powers a Focused, Capital Efficient Business Plan<br>8<br>• Advancing a select few<br>“fast followers”<br>• Potential licensing and asset<br>sales for other molecules<br>• Partner existing molecules or<br>discovery projects against new<br>targets<br>• Potential for upfront, milestone<br>payments and/or royalties<br>AI Discovery<br>Platform<br>Proprietary<br>Pipeline<br>Discovery<br>Partnerships
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Potential Pipeline Value is Validated by Robust Early-Stage Deals<br>9<br>2018<br>SEP 2018<br>IBIO-101 (CD25)<br>Roche / Tusk Therapeutics:<br>$81M upfront,<br>$758M total deal value<br>2019 2020<br>SEP 2020<br>CCR8<br>Gilead / Jounce:<br>Original Deal:<br>$85M upfront,<br>$35M equity investment,<br>$685M milestones<br>2023 Buyout by Gilead:<br>$67M for remaining stake<br>2021<br>FEB 2021<br>PD-1 agonist<br>Merck / Pandion:<br>Acquired for $1.85B<br>JUN & DEC 2021<br>CCR8<br>Fibrogen / HiFiBio:<br>$25M option fee,<br>$35M option exercise,<br>$1.1B milestones<br>JUL 2021<br>CD3<br>Eli Lilly / Merus :<br>$40M cash upfront,<br>$20M investment,<br>$540M milestones<br>JUL 2021<br>CD3<br>Amgen / Teneobio:<br>$900M acquisition upfront<br>$1.6B potential downstream<br>2022<br>MAY 2022<br>EGFR-vIII<br>Taiho / Cullinan Oncology:<br>$275M upfront,<br>$130M in milestones<br>AUG 2022<br>PD-1 agonist<br>Gilead / Mirobio:<br>Acquired for $405M<br>SEP 2022<br>EGFR-vIII<br>Seagen / LAVA Therapeutics:<br>$50M upfront,<br>$650M in milestones<br>OCT 2022<br>CD3<br>Gilead / MacroGenics :<br>$60M upfront<br>$1.7B milestones
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IBIO-101<br>IL-2 Sparing Anti-CD25<br>10
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IBIO-101 for Regulatory T-Cell (Treg) Depletion<br>Recent Transactions<br>PRECLINICAL TESTING IND CLINICAL TESTING CLINICAL PROOF OF CONCEPT<br>*Roche / Tusk Therapeutics (Sep, 2018)<br>$81M upfront,<br>$758M total deal value<br>**Roche Ph1 Data (Apr, 2023)<br>Well-tolerated: manageable safety profile<br>Confirmed MOA: Reduced intratumoral Tregs<br>Efficacy: 29% stable disease (45% PD-L1 combo)<br>*Roche acquisition of Tusk Therapeutics completed for €70M upfront, acquiring worldwide rights to anti-CD25 program. Values converted to dollars as reported in public press releases<br>**Data presented by Roche at AACR 2023<br>• IL-2 sparing anti-CD25 antibodies<br>enables depletion of Tregs without<br>affecting Teffs<br>• Fast-follower to Roche’s RG6292<br>clinical molecule<br>Differentiation / Opportunity<br>• Solid tumors<br>• Hairy cell leukemia<br>• Relapsed mult. myeloma<br>• Lymphoma<br>• Head & neck cancer<br>Potential Indications<br>Depletion of<br>immunosuppressive Tregs<br>via antibody<br>dependent cellular<br>cytotoxicity (ADCC),<br>without disrupting<br>activation of effector<br>T-cells (Teffs) in the tumor<br>microenvironment<br>Target Mechanism<br>11
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IBIO-101 Reduces Tumor Growth in Preclinical Studies by Selectively Depleting<br>1st Gen CD25<br>Immunosuppressive Tregs without Affecting Cancer Killing Teffs<br>Blocked IL-2 pathways<br>IL-2<br>CD25<br>(IL-2Rα)<br>JAK JAK<br>Treg<br>JAK<br>Teff<br>JAK<br>Indiscriminate<br>depletion of<br>Treg<br>+ Teff<br>TUMOR<br>1<br>st gen CD25 mAbs<br>depleted immuno-suppressive Treg and<br>immuno-stimulatory Teff<br>Limited efficacy<br>2<br>nd gen IBIO-101<br>selectively targets Tregs<br>without blocking IL-2<br>signaling to Teffs<br>Strong preclinical<br>anti-tumor response<br>Data on file. Treg = Regulatory T Cells; Teff = Effector T Cells; ADCC = Antibody Dependent Cellular Cytotoxicity 12<br>Teff Treg<br>JAK JAK JAK JAK<br>Proliferation<br>eff<br>TUMOR T<br>ADCC<br>IL-2<br>Natural IL-2 signaling<br>Killer Cell<br>Preferential Treg<br>depletion<br>IBIO-101
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IBIO-101 Selectively Depletes Tregs<br>IBIO-101 potently binds<br>recombinant CD25<br>while preserving<br>IL-2 signaling<br>which leads to Treg<br>depletion<br>while sparing Teffs<br>RG6292 is Roche’s monoclonal antibody that targets CD25 (IL-2Rα). 13<br>IBIO-101 data on file.
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IBIO-101 Increases in Teff/Treg Ratio in Preclinical Studies<br>Inhibiting Tumor Growth<br>Potently increases T-eff/T-reg<br>ratio1<br>Tumor growth inhibition<br>correlates with T-eff/T-reg ratio<br>* Significant vs<br>hIgG1 Isotype<br>1hCD25 animal model - Data on file. 14<br>* Significant vs Negative Control
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IBIO-101 in Combination With a Checkpoint Inhibitor Shows Greater Efficacy<br>*hCD25 animal model - Data on file. 15<br>* Significant vs Negative Control<br># Significant vs Anti-PD-1<br>IBIO-101 + PD-1 Checkpoint Inhibitor In PreClinical<br>Studies Enhances Tumor Suppression
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IBIO-101 is an Antibody With Favorable Characteristics for CMC Development<br>16<br>Potential for Master Cell Bank (MCB)<br>Development From 8 Promising Cell Lines<br>Unoptimized Cell Lines Already Show<br>Promising IBIO-101 Yields<br>• Identified manufacturing partner to produce IBIO-101 for Phase 1&2 clinical<br>trials<br>• Discovered suitable cell lines for manufacturing MCB<br>• Established IBIO-101 CMC methodology for producing high yield, high purity,<br>stable product under cGMP conditions
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Anti-CCR8<br>High ADCC Anti-CCR8 for the<br>Depletion of T-regulatory Cells<br>17
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CCR8 for Tumor-Infiltrating Treg Depletion<br>Recent Transactions & Milestones<br>PRECLINICAL TESTING IND CLINICAL TESTING CLINICAL PROOF OF CONCEPT<br>*Fibrogen / HiFiBio (Jun. & Dec. 2021):<br>$25M option fee, $35M option exercise,<br>$1.1B milestones<br>**Gilead / Jounce (Dec. 2022):<br>Original deal: $85M upfront, $35M<br>equity investment, $685M milestones.<br>2023 Buyout: $67M for remaining rights.<br>*Fibrogen / HiFiBio: Fibrogen purchased option to multiple programs in June 2021, then exercised the option for excl. license to CCR8 program in Dec. 2021.<br>**Gilead / Jounce: Exclusive worldwide license to anti-CCR8 antibody.<br>• Selective binding to CCR8<br>over its close homolog, CCR4<br>Differentiation / Opportunity<br>• Broadly applicable in solid<br>tumors<br>• Prospective combination<br>therapy<br>Potential Indications<br>Tumor-infiltrating Tregs<br>highly express CCR8.<br>iBio program targets<br>depletion of highly<br>immunosuppressive<br>CCR8+ Tregs in tumor<br>microenvironment via<br>an ADCC mechanism.<br>Target Mechanism<br>18
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CCR8+ Treg Cells Are Tumor Infiltrating and Highly Immunosuppressive<br>Depletion of CCR8+ Treg cells has potential to evoke potent tumor immunity<br>Zheng, et al. Cell 169.7 (2017): 1342-1356; Whiteside, et al. Immunology 163(4) (2021): 512-520; Kidani, et al. PNAS 119(7) (2022): e2114282119 19<br>CCR4+ cells spared Intratumor cytotoxic T-cell<br>activation & tumor death<br>CCR8 & CCR4<br>nonspecific antibody<br>iBio CCR8<br>specific antibody<br>• Systemic inflammation<br>• Skin toxicity<br>• Platelet<br>depletion/aggregation<br>CCR4+ cells killed Adverse events
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Afucosylated Anti-CCR8 Antibody Exhibits High Specificity, CCL1<br>Antagonism and CCR8-Specific Cell Killing<br>Data on file 20<br>CCR8 overexpressed cell<br>hCCR8 overexpressed cells<br>hCCR4 overexpressed cells<br>% of cell killing<br>High Specificity CCR8 Cell Binding<br>Potent binding to CCR8 overexpressing cells<br>10<br>8<br>hIgG1 isotype<br>CCR8-CCL1 Antagonism<br>Anti-hCCR8 (+)Ctl.<br>SD-356253 (iBio)<br>6<br>4<br>2<br>0<br>0.0001 0.001 0.01 0.1 1 10<br>Ab. (nM)<br>mIgG2A isotype<br>Anti -hCCR4 - EC50 = NA<br>Anti-mCCR8 - EC50 = NA<br>SD-356253 - (iBio) - EC50 = 0.78 nM<br>SD-692676 - (GS-1811) - EC50 = 0.43 nM<br>(Jounce/Gilead)<br>SD-6926776-(GS-1811) Jounce/Gilead<br>CCL1 (7 nM)<br>CCL1 (7 nM) + hIgG1 Iso. Ctl.<br>Untreated<br>No binding to CCR4 overexpressing cells<br>50<br>PBMC-Induced CCR8 Cell Killing<br>40<br>40<br>hIgG1 isotype 30<br>30 mIgG2A isotype<br>20<br>20 Anti -hCCR4 - EC50 = 42.5 nM<br>Anti-mCCR8 - EC50 = NA 10<br>hIgG1<br>hCCR4 - EC50 =NA<br>SD-356253-(iBio) - EC50 = 0.004 nM<br>10 SD-356253 - (iBio)- EC50 = NA SD-692676-(GS-1811) - EC50 = 0.002 nM<br>0<br>0.0001 0.001 0.01 0.1 1 10<br>Ab. (nM)<br>SD-692676 - (GS-1811)- EC50 = NA<br>(Jounce/Gilead)<br>0<br>Ab. (nM)<br>(Jounce/Gilead)<br>MFI MFI
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Unlocking the Power of Bi-Specific Antibodies<br>with Our Versatile CD3 mAb Panel<br>Wide Range of Affinities, Non-Human Primate<br>(NHP) Cross Reactivity, High Developability<br>21
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Next Generation Anti-CD3 T Cell Engagers<br>Recent Transactions & Milestones<br>PRECLINICAL TESTING IND CLINICAL TESTING CLINICAL PROOF OF CONCEPT<br>*Eli Lilly / Merus (July 2021):<br>$40M cash upfront, $20M<br>investment, $540M milestones,<br>plus royalties<br>**Amgen / Teneobio<br>(July 2021):<br>$900M acquisition upfront,<br>$1.6B potential downstream<br>***Gilead / MacroGenics<br>(Oct 2022):<br>$60M upfront, $1.7B<br>milestones, plus royalties<br>*Eli Lilly / Merus: Fibrogen Research collaboration using Merus’ proprietary platform to develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies.<br>**Amgen / Teneobio: Teneobio was developing a heavy-chain only platform as well as its CD3 engager technology. TNB-585, the lead program, was in phase 1. 22<br>*** Gilead / MacroGenics: Gilead granted option to MGD024, a phase 1 CD3 bi-specific, plus collaboration on two additional research programs.<br>• Range of T cell activation for<br>diverse tumor antigens<br>• Cyno-tox study compatibility<br>• StableHu optimized sequence<br>reduces downstream risks<br>Differentiation / Opportunity<br>• Broad solid tumor potential<br>• Expands therapeutic options<br>across programs<br>Potential Indications<br>T-cell-redirecting<br>bispecific antibodies are<br>a new therapeutic class<br>that simultaneously<br>targets CD3 on T cells<br>and tumor antigens,<br>inducing T cell mediated<br>tumor cell killing<br>Target Mechanism
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CD3 T Cell Engager Panel Overcomes Key Challenges<br>23<br>Sequence Diversity 2 Hu-Cyno Cross-Reactivity 3 Range of Cytokine Release<br>Broad CD3 activity for optimized<br>paring with tumor antigen arms<br>Risk reduction via cyno monkey<br>toxicity study compatibility<br>Tailored cytokine release for expanded<br>therapeutic window<br>Diverse<br>CD3<br>engager arms<br>Numerous<br>tumor<br>antigen arms Release of<br>Tumor<br>cell<br>death<br>Granzyme,<br>Perforin Increased<br>cytotoxicity<br>Activated<br>T cell<br>cytotoxic granules<br>Tumor cell<br>Release of<br>cytokines Reduced<br>cytokine<br>release<br>1<br>TNFα, IFNγ,<br>IL-2, (IL6)<br>Cascade of<br>immune activation
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Dual Approaches to a Diverse Panel of Anti-CD3 Antibodies<br>Data on file 24<br>Activation<br>Binding<br>Structural-Epitope Immunization & Screening<br>StableHu Optimizer<br>Hu/Cyno CD3 & T Cell<br>T Cell<br>ID<br>1<br>2<br>3<br>4<br>5<br>6<br>(-) Ctl<br>Template 1 Template 2<br>2 Template<br>Antibodies<br>Optimized<br>Antibodies<br>TCR<br>CD3<br>Engineered<br>Epitopes<br>AI-Engineered<br>Immunogens<br>Epitope & T Cell<br>Immunization<br>Epitope &<br>CD3 Screen<br>AI Discovery<br>Engine SCREEN
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Libraries and Screens Discover Hu-Cyno CD3 Cross-Reactive Antibodies<br>Data on file 25<br>Library<br>Screen:<br>StableHu<br>Mammalian-Display<br>Epitope-Steered<br>Immunization<br>Human T Cell<br>Binding<br>High<br>Medium<br>Low<br>Selected Hit<br>Not Selected
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CD3 Panel is Selected for a Diversity of T Cell Binding and Activation<br>Data on file 26<br>T Cell Assay:<br>EC50: 3 – 570 nM EC50: 2.5 – 70 nM<br>Hit Clones Hit Clones<br>Ab Concentration (nM)<br>ID<br>1<br>2<br>3<br>4<br>5<br>(-) Ctl<br>SP34<br>Gen1 benchmark SP34 Gen 1 benchmark<br>Binding Activation Cytokines<br>Human T Cell Binding EC50 (nM)<br>CD69 T Cell Activation EC50 (nM)<br>IFN-γ (pg/mL) TNF-⍺ (pg/mL) IL-2 (pg/mL)
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Anti-EGFRvIII<br>High ADCC mAb Against<br>Tumor-Specific EGFRvIII Cells<br>27
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EGFRvIII for Glioblastoma and Other Cancers<br>Recent Transactions<br>PRECLINICAL TESTING IND CLINICAL TESTING CLINICAL PROOF OF CONCEPT<br>*Seagen / LAVA Therapeutics (Sep. 2022):<br>$50M upfront,<br>$650M in milestones<br>**Taiho / Cullinan Oncology (May 2022):<br>$275M upfront,<br>$130M in milestones<br>*Seagen transaction with LAVA Therapeutics was an exclusive license to LAVA-1223 (EGFR program), plus additional projects using Lava’s platform.<br>**Taiho transaction to acquire Cullinan Oncology’s subsidiary, Cullinan Pearl, which has worldwide rights outside of Japan to CLN-081/TAS6417 (EGFR mutant mAb).<br>• Novel EGFRvIII high ADCC<br>mechanism, potentially further<br>reducing toxicity & expanding<br>therapeutic window<br>• Other enabling modalities: T Cell<br>engager, ADC, CAR-T<br>Differentiation / Opportunity<br>• Glioblastoma<br>• Head & neck cancer<br>• Non-small cell lung cancer<br>Potential Indications<br>Binding a tumor-specific mutation of<br>EGFR variant III with an<br>afucosylated<br>antibody for high<br>ADCC.<br>EGFRvIII is constantly<br>“switched on” which<br>can lead to the<br>development of a<br>range of different<br>cancers.<br>Target Mechanism<br>28
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iBio’s Anti-EGFRvIII mAbs Selectively Kill EGFRvIII-Positive Tumor Cells and<br>Non EGFRvIII specific mAbs kill cancer cells but can cause toxicity by binding to EGFR1 in skin cells<br>Not EGFR1-Expressing Cells in Healthy Tissues<br>iBio mAb binding<br>specifically to EGFRvIII<br>Tumor Size<br>Reduction<br>Non-EGFRvIII<br>specific mAb<br>binds to EGFR1<br>in skin<br>Skin toxicity<br>Tumor Size<br>Reduction<br>iBio mAb binding<br>specifically to EGFRvIII<br>iBio mAb<br>doesn’t bind to<br>EGFR1 in skin<br>No skin damage<br>Data on file 29<br>iBio’s EGFRvIII-specific mAb exclusively kills cancer cells
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iBio’s EGFRvIII-Selective mAbs Kill Tumor Cells without Affecting Healthy Cells<br>iBio EGFRvIII mAbs bind<br>recombinant EGFRvIII<br>but not binding wild-type<br>EGFR1<br>which leads to<br>tumor cell killing<br>and thus not affecting<br>healthy cells<br>Data on file 30
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Anti-MUC16 Tumor Associated Epitope<br>Non-Shed Epitope Anti-MUC16 Antibody<br>31
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MUC16 Potential for Ovarian and Other Cancers<br>32<br>Recent Transactions & Milestones<br>PRECLINICAL TESTING IND CLINICAL TESTING CLINICAL PROOF OF CONCEPT<br>2seventy – Regeneron<br>(Jan 2022):<br>CAR T 2023 IND planned<br>Genentech (Sept 2021):<br>ADC Ph. 1: Favorable<br>safety & efficacy<br>Eureka – Juno/BMS<br>(Jan 2016):<br>CAR T Ph. 1 ongoing<br>Regeneron MUC16xCD3<br>(Sept 2022):<br>Ph. 1 31% ORR<br>Ph. 2 enrollment<br>• MUC16 epitope avoids<br>primary modes of tumor<br>evasion<br>• Enabling modalities: T Cell<br>engager, ADC, CAR-T<br>Differentiation / Opportunity<br>• Ovarian<br>• Uterine<br>• Pancreatic<br>Potential Indications<br>Bind a membrane-proximal MUC16 epitope<br>Membrane-proximal<br>binding avoids epitope<br>elimination by tumors<br>Bind a non-glycosylated<br>epitope to avoid altered<br>glycosylation on tumors<br>Target Mechanism
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MUC16 Is Overexpressed and Shed by Tumor Cells<br>33<br>O-glycosylation N-glycosylation<br>N-terminal and<br>tandem repeat (TR)<br>domains that are shed<br>Tumor associated<br>epitope that is not shed<br>MUC16<br>epitope<br>shedding<br>Shedding eliminates<br>the epitope and<br>creates an antigen sink<br>for most MUC16<br>antibodies<br>Antibodies that bind<br>the non-shed domain<br>maintain activity<br>Ovarian<br>cancer cells
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Immunizations Were Steered to a MUC16 Epitope that Avoids Epitope Shedding<br>34<br>Structural-epitope Immunization & Screening OVCAR-3 MUC16high<br>Cell Binding Screen<br>Engineered Epitope Prime + MUC16 Cell Boost<br>higher cell binding<br>Hybridoma<br>Screen<br>Weeks 1–2<br>MEM<br>Nanoparticle<br>Weeks 3–4<br>MUC16<br>Expressing Cells<br>Week 5<br>MEM + Cells<br>AI Discovery<br>Engine<br>MUC16<br>Engineered<br>Epitope<br>MUC16<br>Non-shed<br>Aglycosylated<br>Epitope<br>Engineered Epitope<br>ELISA Screen
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Top Three Hit Clones Bind the Non-Glycosylated MUC16 Epitope<br>Closest to the Membrane<br>35<br>N-terminal and<br>tandem repeat (TR)<br>domains that are shed<br>Epitope<br>time<br>Hits do not bind shed 230-mer<br>1D7 8G4 21G6<br>Hits bind non-glycosylated non-shed 29-mer<br>KD = 8.0 nM KD = 5.4 nM KD = 14 nM<br>Aglycosylated<br>non-shed<br>29-mer<br>O-glycosylation N-glycosylation<br>Shed<br>230-mer<br>binding
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Top MUC16 Clone 8G4 Binds OVCAR-3 Cells Comparable to Regeneron<br>Benchmark<br>36<br>Clone ID:<br>Unstained<br>Secondary Only<br>OVCAR-3 Cells<br>8G4<br>top clone<br>higher cell binding<br>Regeneron<br>benchmark<br>Mode Normalized
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8G4 Clone Maintains OVCAR-3 Cell and MUC16 Epitope Binding in a Fully<br>Human Framework<br>37<br>8G4 with fully human framework<br>reduces immunogenicity risk<br>Cell<br>binding<br>OVCAR-3 Cells<br>Iso. Ctl<br>higher cell binding<br>Glycosylated MUC16 membrane-proximal epitope SPR:<br>KD = 5.1 nM<br>Epitope<br>binding
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PD-1 Agonist<br>Supports Restoration of Homeostasis<br>for Inflammatory Diseases<br>38
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PD-1 Agonist to Alleviate Inflammatory Disease<br>39<br>Recent transactions and milestones<br>PRECLINICAL TESTING IND CLINICAL TESTING CLINICAL PROOF OF CONCEPT<br>Merck / Pandion:<br>Acquired for $1.85B<br>(multiple assets,<br>most advanced Ph 1a)<br>Gilead / Mirobio:<br>Acquired for $405M<br>(two checkpoint agonists,<br>most advanced Ph1)<br>Lilly:<br>Positive Ph 2a efficacy<br>in RA patients<br>• Potent PD-1 agonism vs.<br>benchmarks with in vitro<br>reporter and primary cell<br>assays<br>Differentiation / opportunity<br>• Rheumatoid arthritis<br>• Broad application in treating<br>inflammatory disease<br>Potential indications<br>Selectively agonize<br>PD-1 without<br>antagonizing the<br>natural PD-1:PD-L1<br>anti-inflammatory<br>interaction<br>Target mechanism
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Antagonizing PD-1 with PD-L1 Blocking Worsens Autoimmunity and Systemic<br>Inflammation<br>40<br>Worsened<br>Autoimmunity<br>Increased &<br>systemic<br>inflammation<br>Strong<br>T-cell<br>inhibition<br>TCR MHC<br>PD-1 PD-L1<br>Antigen<br>presenting<br>cell<br>No<br>T-cell<br>inhibition<br>T-cell<br>PD-1<br>Antagonist<br>Antibody<br>Weak<br>T-cell<br>inhibition<br>No<br>T-cell<br>inhibition<br>Inflammatory<br>Disease Tissue<br>Healthy<br>Tissue
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Agonizing PD-1 Without Blocking PD-L1 Restores Activated T-Cell<br>Suppression<br>41<br>Improved<br>Autoimmunity<br>Healthy Tissue<br>Low-inflammation<br>preserved<br>Diseased Tissue<br>Reduced<br>inflammation<br>Strong<br>T-cell<br>inhibition<br>TCR MHC Strong<br>T-cell<br>inhibition<br>PD-1 PD-L1<br>Antigen<br>presenting<br>cell<br>T-cell<br>PD-1<br>Agonist<br>Antibody<br>Weak<br>T-cell<br>inhibition<br>Strong<br>T-cell<br>inhibition<br>Inflammatory<br>Disease Tissue<br>Healthy<br>Tissue
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In vitro PD-1 Agonism Equals or Surpasses Benchmarks and PD-L1<br>Data on file 42<br>Ab ID EC50<br>(nM)<br>SD-671823 0.88<br>SD-300670 0.31<br>SD-030629 0.36<br>SD-136366 0.28<br>SD-759028 0.52<br>SD-313018 (bispecific) 0.30<br>AnaptysBio<br>APE12095 17.4<br>BMS/Celgene<br>PD1AB6 0.76<br>IgG1 isotype control inactive<br>AnaptysBio APE12095 BMS/Celgene PD1AB6 IgG1 isotype control<br>SD-136366 SD-759028 SD-313018 (bispecific)<br>Tetravalent<br>SD-671823 SD-300670 SD-030629<br>Bivalent<br>PD-1 Agonist Antibodies<br>Benchmark<br>Antibodies
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Primary T-Cell Suppression Equals or Surpasses Benchmarks and PD-L1<br>Data on file 43<br>iBio Molecules Benchmark Molecules Natural Agonist<br>Mean of<br>6 donors<br>IL-2 at 24 hrs.<br>300<br>CD69 at 72 hrs.<br>200<br>200<br>100<br>Anti-HEL IgG1<br>Isotype Control<br>100<br>Anti-HEL IgG1<br>Isotype Control<br>0 0<br>Mean of<br>6 donors<br>% IL-2 Release<br>CD69 MFI
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In Summary<br>44
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Our Leadership Team Brings Drug Discovery and Development Experience<br>Martin Brenner, DVM, Ph.D.<br>Interim CEO & CSO<br>Felipe Duran<br>Interim CFO<br>Marc Banjak<br>GC<br>Lisa Middlebrook<br>CHRO<br>45
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Summary<br>Pipeline of difficult<br>to find biologics<br>• Pipeline of 10 preclinical<br>primarily immuno-oncology (I/O) biologics<br>• Targets have been of<br>interest to major I/O<br>companies<br>• Lead asset (IBIO-101) is<br>a next-generation anti-CD25 (fast follower to<br>Roche’s RG6292)<br>• IBIO-101 CMC<br>development is<br>underway<br>AI-driven discovery<br>tech stack<br>• Patented epitope-engineering steers<br>discovery to target sites<br>• StableHu optimizer<br>improves hits with<br>human diversity to<br>reduce immunogenicity<br>• Leading mammalian<br>display capability<br>enhances hit diversity<br>and developability<br>Preclinical development<br>capability<br>• Preclinical team with a<br>history of quickly and<br>efficiently moving<br>candidates to the<br>clinic<br>• Built >10-product<br>pipeline in 18 months<br>Financial<br>• Ticker: IBIO (NYSE<br>AMERICAN); ~12.4M shares<br>outstandingas of 12/31/22<br>• Reduced SG&A spend;<br>expecting run rate of<br>approximately<br>$2M per month<br>• $9.9M of cash/cash<br>equivalents as of 12/31/22<br>46
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