8-K - IBIO - Equibles

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): October 3, 2022

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 October 2022

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.

IBIO, INC.

By:	/s/ Thomas F. Isett
	Name:	Thomas F. Isett
	Title:	Chief Executive Officer

Exhibit 99.1


	GrowingTomorrow’s Biologics CORPORATE PRESENTATION October 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 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.

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 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.

3 iBio: A Biopharmaceutical Discovery & Development Company Proprietary Pipeline FastPharming® Manufacturing Platform Proprietary plant-based protein expression system Focused on Immuno-Oncology Patented AI-Driven Discovery Engine Identification and engineering of hard-to-target epitopes GlycaneeringSM Technology Advanced recombinant protein engineering Development & Manufacturing Services Delivering speed, scalability, and sustainability

Platforms

5 Unique Solutions for Some of the Industry’s Biggest Problems Biopharmaceutical Development Challenges Our Solutions 1 2 3 SO L U T I O N S Discovery Engine Program Failures Time / Cost Biomanufacturing Only ~5 in 5,000 drug concepts reach the >1 year & ~$3-7M for scalable bioprocess & Drug industry is 55% more emissions intensive GlycaneeringTM clinic Ph1 material1 than the auto industry2 Dev/Mfg Services 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

6 RubrYc AI-Powered Discovery Target" Binding Sites Engine: Drug Discovery for ”Hard-to-The Problems Our Solutions RubrYc® Discovery Engine* Subdominant Epitopes Sites often missed with standard screening Conformational Epitopes Binding sites spread across amino acid chains Better Antibody Designs à Fewer Failures *Patent Pending COOH Antibody Design for Subdominant or Conformational Epitopes

7 End-to-End Computational Biology System for Enhanced Identification & Engineering of Large-Molecule Drug Candidates Engineered Epitope Optimize with StableHuTM AI Engine Human Optimized mAb Lead Pool Epitope Antibody Hits On-Epitope Clinical Candidate Targeting Engine RubrYcHuTM Library 1 2 3 Epitope-specific mAb panels are rapidly processed through screening funnels 4 AI-powered sequence optimization to improve performance 5 AI-generated human Optimized Leads are evaluated and ranked in translational disease models AI-powered precision library, free of sequence liabilities, provides a targeting of confirmational & sub-dominant epitopes unique pool of mAbs

8 FastPharming: Green Protein Expression System 1 130,000 sf Facility 2 3 4 5 Seeding & Growth Bacterial Infiltration (Transient Transfection) Protein Production Harvesting Purification & Vialing Gene Cloning Mobilization

9 The Speed & Scalability of FastPharming Potentially Enables a Faster, More Efficient Path to the Clinic (Bacterial) ubstance brings the capability to avoid the significant cost and time associated with selecting, developing & banking mammalian cell lines 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. Master Cell Bank Drug S Manu facture Master Cell Bank (Mammalian) Drug Substance Manufacture mo n t h s mo n t h s Candidate Generation

10 iBio Platforms Potentially Enable More Promising Candidates to Reach the Clinic, Faster RubrYc Discovery Engine + Current Drug Development Challenge + GlycaneeringTM Technology ycan ~4x 40 year s 0 Standard 1https://www.researchgate.net/publication/265288848_The_Global_Biomedical_Industry_Preserving_US_Leadership CD M O SER V ICES ADCC ACTIVITY (%) [1.6ng/ml] Increased Potency with Glycaneering Industry Benchmarks to Reach IND1 Success RateTimeCost <5 in 5,000>3 Years>$20M 80 Gl eered Rituximab ~5,000 – 10,000250 COMPOUNDS DRUG DISCOVERY PRECLINICAL CLINICAL TRIAL

11 Reducing Single-Use Plastic Disposables in Upstream Processing The FastPharming Bioreactor uses all-natural raw materials >85% of pre-commercial bioprocesses involve VS single-use plastic disposables1 Seeds Stone Wool Purified Water 117th Annual Report and Summary of Biopharmaceutical Manufacturing Capacity and Production https://www.biopharma.com/TRENDS.pdf

12 Pipeline Growth Driven by Immuno-Oncology Program Fibrotic Diseases IBIO-100 * Developed using the RubrYc Discovery Engine ANIMAL HEALTHPROGRAMSPOCPRE-CLINICALCLINICAL DEVPRODUCT REGISTRATION Infectious DiseaseIBIO-400Classical Swine Fever Vaccine HUMAN HEALTHPROGRAMSEARLY DISCOVERYLATE DISCOVERYLEAD OPTIMIZATIONIND-ENABLINGCLINICAL IBIO-101 Solid Tumors RTX– 003 Endostatin E4Solid Tumors Target 3Immuno-Oncology Target 4Immuno-Oncology OncologyTarget 5Immuno-Oncology Target 6 Immuno-Oncology* Target 7 Immuno-Oncology* Target 8 Immuno-Oncology* Target 9 Immuno-Oncology* AutoimmunePD-1Autoimmune Diseases* Systemic Scleroderma Idiopathic Pulmonary Fibrosis

Immuno-Oncology

14 Deploying AI-based Target ID/Engineering & Glycaneering to Create More, Higher-Quality, Anti-Cancer Candidates iBio Discovery & Pipeline More shots-on-goal, 1 Dev Approach sooner AI Discovery Platform Drug Discovery Clinical Preclinical Identifying failures 2 earlier, saving costs Accelerating development 3 1 2 3 timelines Glycaneering Technology As programs advance, additional opportunities to partner molecules and supply with FastPharming Services THE R A P E U TI C S

15 IBIO-101 (Lead Depletion Program) Stimulates Anti-tumor Immunity via anti-CD25 Treg IBIO-101 IL-2 signaling Natural Killer Cell IL-2 ADCC Teff Tumor JAK JAK JAK JAK Proliferation Treg Preferential Treg depletion 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 1Data on file Treg = Regulatory T Cells; Teff = Effector T Cells; ADCC = Antibody Dependent Cellular Cytotoxicity THE R A P E U TI C S

16 Characteristics of Plant and CHO Made Molecules are Comparable IBIO-101 demonstrates equivalent binding kinetics compared with RTX-003 Phan, et al. "Plant-Based Expression and Glyco-Engineering of Novel IL-2 Signaling Permissive Anti-CD25 Antibodies for Effective Treg Depletion in Cancer” THE R A P E U TI C S RTX-003 WT4.71E+051.92E-034.100.37 RTX-003 afuc4.99E+051.91E-033.91.03 IBIO-101 WT4.85E+051.96E-034.200.69 IBIO-101 afuc4.92E+052.07E-034.271.27 IBIO-101, Plant afucosylated RTX-003, CHO afucosylated AF U C O S Y L AT E D CH O M A DE M O L E CU L E +GlycaneeringTM IBIO-101, Plant WT RTX-003, CHO WT CH O M A DE M O L E CU L E

17 FastPharming and CHO Produced Molecules Bind Potently to CD25, Which is Commonly Expressed by Treg Cells IBIO-101 and RTX-003 show nearly identical binding to recombinant human and non-human primate CD25, but don’t cross react with recombinant mouse CD25 protein Phan, et al. "Plant-Based Expression and Glyco-Engineering of Novel IL-2 Signaling Permissive Anti-CD25 Antibodies for Effective Treg Depletion in Cancer” THE R A P E U TI C S RTX-003 EC50 = 15.7 ng/mL Human CD25 IBIO-101 EC50 = 16.9 ng/mL Non-human Primate CD25 IBIO-101 EC50 = 41.2 ng/mL RTX-003 EC50 = 43.8 ng/mL Mouse CD25 IBIO-101 RTX-003

18 FastPharming and CHO Produced Molecules Bind to CD25-Positive Human Tumor Cells; and Don't Interfere with Important IL-2 Signaling RTX-003 EC = 0.14 ng/mL IBIO-101 and RTX-003 bind to SUDHL1 human lymphoma cells and don’t interfere with IL-2 stimulated STAT5 activation Phan, et al. "Plant-Based Expression and Glyco-Engineering of Novel IL-2 Signaling Permissive Anti-CD25 Antibodies for Effective Treg Depletion in Cancer” THE R A P E U TI C S (STAT5 activation in IL-2R overexpressing cell line) IBIO-101 EC = 0.14 ng/mL IL-2 Signaling IL2 EC50 = 0.11 ng/mL 50 50 SUDHL1 Cells (CD25-positive cancer cells) IBIO-101 EC50 = 178.8 ng/mL RTX-003 EC50 = 125.9 ng/mL

19 FastPharming and CHO Produced Molecules Have Similar Potency and Efficacy in Cancer Cell Killing Assays Efficacy and potency of IBIO-101 and RTX-003 are comparable in antibody-dependent cellular cytotoxicity assays using a reporter assay or primary human PBMC Phan, et al. "Plant-Based Expression and Glyco-Engineering of Novel IL-2 Signaling Permissive Anti-CD25 Antibodies for Effective Treg Depletion in Cancer” THE R A P E U TI C S RTX-003 EC50 = 7.2 ng/mL ADCC reporter assay IBIO-101 EC50 = 11.2 ng/mL ADCC human PBMC assay IBIO-101 EC50 = 1.57 ng/mL RTX-003 EC50 = 1.69 ng/mL

·I a"10 In Summary

21 Our Leadership Team Brings Drug Development & Bioprocessing Experience Marc Banjak GC Lisa Middlebrook CHRO Robert Lutz, MBA CFBO Martin Brenner, DVM, Ph.D. CSO Tom Isett CEO & Chairman

22 Strong and Growing IP Estate Provides Exclusivity for iBio’s Pipeline Applications Active Applications Issued Patents Patent Protection Includes: • • • • Intellectual property [IP] around iBio’s biopharmaceutical candidates IP related to the Drug Discovery platform (including Notice of Allowance from USPTO) 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 IP • Settled iBio v. Fraunhofer USA for $28M in May 2021 10732More (25 U.S.)(9 U.S.)progressing to filing

23 iBio: Leveraging Capabilities Combing platforms to create a biotech company with its own end-to-end discovery capabilities Pipeline of promising immunotherapy candidates, with a focus on immuno-oncology Discovery Pipeline Partnering Leveraging patented platforms for both in-licensing and out-licensing