PART I [Business](index=4&type=section&id=Item%201.%20Business) iBio, Inc. has transformed into a preclinical biotechnology company, leveraging its proprietary AI technology for precision antibody development, primarily in immuno-oncology [Overview](index=4&type=section&id=Overview) iBio is a preclinical biotechnology company focused on AI-driven precision antibody development after divesting its CDMO business in September 2022 - The company has transitioned into a preclinical stage biotechnology firm specializing in AI-driven development of precision antibodies[13](index=13&type=chunk) - A strategic pivot occurred in September 2022 with the acquisition of substantially all assets from RubrYc Therapeutics, Inc., leading to the divestiture of the company's Contract Development and Manufacturing Organization (CDMO) business[14](index=14&type=chunk) - iBio's technology stack features a patented epitope-steering AI-engine for precise targeting and a machine learning-based antibody-optimizing technology, StableHu™, to accelerate lead optimization and reduce development risks[15](index=15&type=chunk) [Strategy](index=7&type=section&id=Strategy) iBio's strategy focuses on leveraging its AI-engine for novel biologic discovery, maintaining capital efficiency through collaborations, and continuously investing in its AI platform - The company's core mission is to use AI and machine learning to discover novel biologics that have been difficult for other scientists to develop[26](index=26&type=chunk) - iBio employs a capital-efficient approach focused on strategic collaborations, cost-effective advancement of its in-house oncology programs, and licensing its AI technology stack in other therapeutic areas like CNS or vaccines[28](index=28&type=chunk) - A key strategic focus is the continuous investment in its AI platform to improve algorithms and models, thereby enhancing predictive power and reducing the time required to identify viable drug candidates[28](index=28&type=chunk) [AI-Technology Platform](index=9&type=section&id=AI-Technology%20Platform) iBio's AI-powered technology stack integrates epitope steering, a human antibody library, StableHu™ AI optimization, and EngageTx™ for advanced antibody discovery and development - The technology stack comprises four key components: epitope engineering, a proprietary antibody library, StableHu AI antibody optimization, and the EngageTx T-cell engager platform[31](index=31&type=chunk)[32](index=32&type=chunk) - The patented AI Epitope Steering Technology guides antibodies to specific, desired regions of a target protein, overcoming limitations of traditional discovery methods, particularly for complex or hard-to-drug targets[36](index=36&type=chunk) - The StableHu™ AI technology, trained on over **1 billion human antibodies**, predicts a library of humanized antibody variants to optimize efficacy and safety, and when paired with mammalian display, it accelerates the lead optimization process[42](index=42&type=chunk)[46](index=46&type=chunk) - The EngageTx™ panel provides next-generation CD3 T-cell engagers designed to retain tumor-killing capacity while significantly reducing cytokine release, and also engineers Non-Human Primate (NHP) cross-reactivity for better preclinical safety assessment[48](index=48&type=chunk)[49](index=49&type=chunk) [Pre-Clinical Pipeline](index=14&type=section&id=Pre-Clinical%20Pipeline) iBio's preclinical pipeline focuses on immuno-oncology with lead candidate IBIO-101 (anti-CD25 mAb) in IND-enabling stage, alongside TROP-2 x CD3 bispecific and other AI-driven antibody programs - The company's lead candidate, IBIO-101 (an anti-CD25 mAb), has advanced to the IND-enabling stage, with an IND filing projected for calendar year **2025**[64](index=64&type=chunk) - The TROP-2 x CD3 bispecific antibody, developed using the EngageTx platform, demonstrated a **36% reduction in tumor size** in a humanized mouse model after a single dose[69](index=69&type=chunk) - Using its AI platform, iBio has developed antibodies targeting the non-shed region of MUC16, a well-known cancer target, to circumvent tumor evasion mechanisms[75](index=75&type=chunk) - The company's anti-EGFRvIII antibody, targeting a tumor-specific protein variant, showed a **43% reduction in tumor growth** in a mouse model for head and neck cancer[86](index=86&type=chunk) - The anti-fibrotic program, IBIO-100, was terminated in February 2023, and the corresponding license agreement with the University of Pittsburgh ceased in August 2023[102](index=102&type=chunk) [Strategic Alliances, Collaborations, and Joint Ventures](index=31&type=section&id=Strategic%20Alliances%2C%20Collaborations%2C%20and%20Joint%20Ventures) iBio engages in strategic collaborations, including a Lassa fever vaccine project with NIAID, and its transformation was driven by the RubrYc Therapeutics asset acquisition and facility divestiture - On June 12, 2023, iBio began a research collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) to use its AI-driven platform for developing a Lassa fever vaccine[106](index=106&type=chunk) - In September 2022, iBio acquired substantially all assets from RubrYc Therapeutics, including the AI Drug Discovery Platform and IBIO-101, for an upfront payment in stock and up to **$5 million** in potential development milestones, terminating prior licensing agreements and royalty obligations[115](index=115&type=chunk) - The company entered into a purchase and sale agreement on September 15, 2023, to sell its Bryan, TX facility for **$17.25 million**, with a closing date of December 1, 2023[129](index=129&type=chunk) - The Credit Agreement with Woodforest National Bank for the Bryan facility has been amended six times, with the maturity date now set for December 31, 2023, and repayment contingent on the facility's sale[122](index=122&type=chunk)[130](index=130&type=chunk) [Intellectual Property](index=40&type=section&id=Intellectual%20Property) iBio holds **95 patents** and **52 pending applications**, with a shifted IP strategy focusing on preclinical assets and including **30 applications** from the RubrYc acquisition - The company owns **95 patents** (**24 U.S., 71 international**) and has **52 pending applications**, with a primary focus on its preclinical antibody assets[134](index=134&type=chunk) - The acquisition of RubrYc's assets included **30 U.S. and foreign patent applications** related to novel antibodies, scaffold technology, and a machine learning apparatus[135](index=135&type=chunk) - In the second quarter of Fiscal 2023, the company impaired intellectual property, patents, and licenses with a net book value of approximately **$565,000** after a strategic review of its product portfolio[137](index=137&type=chunk) [Human Capital/Employees](index=54&type=section&id=Human%20Capital%2FEmployees) As of June 30, 2023, iBio had **23 full-time employees** and **3 CDMO employees**, maintaining competitive compensation and benefits to attract and retain key personnel - As of June 30, 2023, the company had **23 employees** in iBio and **3 employees** in iBio CDMO[186](index=186&type=chunk) - The company's compensation programs are designed to be competitive and include short-term and long-term incentives, with a 401(k) plan offering a **100% match** on employee contributions up to **5% of compensation**[192](index=192&type=chunk)[194](index=194&type=chunk) [Risk Factors](index=58&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, operational, and development risks, including going concern doubts, early-stage pipeline uncertainty, and reliance on third parties and key personnel - There is substantial doubt about the company's ability to operate as a going concern due to a history of net losses, negative cash flow, and an accumulated deficit of **$288.9 million** as of June 30, 2023[217](index=217&type=chunk) - The company's cash, cash equivalents, and restricted cash of **$7.6 million** as of June 30, 2023, are not expected to be sufficient to support operations beyond the second quarter of Fiscal 2024 without further capital raises or asset sales[215](index=215&type=chunk) - The sale of the CDMO facility is subject to closing conditions that are not within the company's control; failure to complete the sale by the term loan's maturity date of December 31, 2023, could lead to default and potential loss of the asset[242](index=242&type=chunk) - All of the company's product candidates are in early preclinical development and require significant, expensive, and time-consuming clinical testing before any potential regulatory approval or commercialization[257](index=257&type=chunk) - The company recently identified and remediated a material weakness in its internal controls related to accounting for stock-based compensation, and cannot assure that future weaknesses will not occur[349](index=349&type=chunk) [Unresolved Staff Comments](index=123&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports that it has no unresolved staff comments from the SEC - None[389](index=389&type=chunk) [Properties](index=123&type=section&id=Item%202.%20Properties) iBio's properties consist of its manufacturing facility in Bryan, Texas, held for sale, and a leased lab and office space in San Diego, California for R&D activities - On September 15, 2023, iBio CDMO entered into an agreement to sell its Bryan, TX facility for a purchase price of **$17,250,000**, with a closing date of December 1, 2023[391](index=391&type=chunk) - The company leases approximately **11,383 square feet** of lab and office space in San Diego, CA for its R&D activities; the lease commenced in September 2022 for a term of seven years and four months[392](index=392&type=chunk) [Legal Proceedings](index=123&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is not currently subject to any material legal proceedings[393](index=393&type=chunk) [Mine Safety Disclosures](index=125&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[396](index=396&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=126&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) iBio's common stock trades on the NYSE American under "IBIO"; the company has never paid cash dividends and effected a 1-for-25 reverse stock split in October 2022 - The company's common stock is traded on the NYSE American under the symbol "IBIO"[399](index=399&type=chunk) - The company has never declared or paid cash dividends on its common stock[400](index=400&type=chunk) - A **1-for-25 reverse stock split** was effected on October 7, 2022; all share and per-share amounts have been retroactively adjusted[402](index=402&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=127&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) iBio's financial condition reflects its transition, with a **$65.0 million** total net loss in FY2023 driven by discontinued CDMO operations, and substantial doubt about its going concern ability due to limited cash Results of Operations (Continuing Operations) | Metric | FY 2023 (in millions) | FY 2022 (in millions) | Change (%) | | :--- | :--- | :--- | :--- | | Revenue | $0.0 | $1.9 | -100% | | R&D Expenses | $10.3 | $9.8 | +5% | | G&A Expenses | $19.0 | $21.8 | -13% | | Net Loss from Continuing Operations | ($29.3) | ($29.6) | -1% | - The loss from discontinued CDMO operations increased by **72%** to **($35.7) million** in FY2023, primarily due to a **$17.9 million** impairment of fixed assets and a **$4.9 million** impairment of consumable inventory[433](index=433&type=chunk) - Total net loss available to stockholders for FY2023 was **($65.0) million**, or **($5.31) per share**, compared to **($50.4) million**, or **($5.78) per share**, in FY2022[434](index=434&type=chunk) - Management has concluded there is substantial doubt about the company's ability to continue as a going concern; cash of **$7.6 million** as of June 30, 2023, is not sufficient to support operations through Q2 FY2024[435](index=435&type=chunk)[440](index=440&type=chunk) - On September 15, 2023, the company entered an agreement to sell its Bryan, TX facility for **$17.25 million**, which is critical for repaying its term loan that matures on December 31, 2023[422](index=422&type=chunk)[438](index=438&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=151&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This information is not required as the company is a smaller reporting company - The information under this item is not required to be provided by smaller reporting companies[492](index=492&type=chunk) [Financial Statements and Supplementary Data](index=151&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section refers to the full consolidated financial statements and supplementary data, which begin on page F-1 of the Annual Report - The company's audited financial statements and notes are included from page F-1 to F-44 of the report[493](index=493&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=151&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[494](index=494&type=chunk) [Controls and Procedures](index=151&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2023, and a material weakness in stock-based compensation accounting was fully remediated - Management concluded that disclosure controls and procedures were effective as of June 30, 2023[500](index=500&type=chunk) - A previously identified material weakness related to internal controls over accounting for stock-based compensation has been fully remediated as of June 30, 2023[505](index=505&type=chunk)[506](index=506&type=chunk) - The Annual Report does not include an attestation report from the independent registered public accounting firm regarding internal control over financial reporting, as permitted for smaller reporting companies[507](index=507&type=chunk) [Other Information](index=155&type=section&id=Item%209B.%20Other%20Information) The company reports no other information under this item - None[509](index=509&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=155&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information for this section is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders[512](index=512&type=chunk) [Executive Compensation](index=155&type=section&id=Item%2011.%20Executive%20Compensation) Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information for this section is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders[514](index=514&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=155&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information for this section is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders[515](index=515&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=155&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information for this section is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders[516](index=516&type=chunk) [Principal Accountant Fees and Services](index=156&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information for this item will be incorporated by reference from the company's definitive proxy statement for its 2023 Annual Meeting of Stockholders - Information for this section is incorporated by reference from the definitive proxy statement for the 2023 Annual Meeting of Stockholders[517](index=517&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=157&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements, schedules, and exhibits filed as part of the Annual Report on Form 10-K, including various agreements and certifications - This section provides an index of all exhibits filed with or incorporated by reference into the Form 10-K[521](index=521&type=chunk) [Form 10-K Summary](index=157&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item is not applicable - Not Applicable[520](index=520&type=chunk) Financial Statements [Consolidated Balance Sheets](index=181&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets decreased to **$41.2 million** from **$99.4 million**, primarily due to reduced cash and reclassified assets held for sale, while total liabilities and equity also declined Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2023 | June 30, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $4,301 | $22,676 | | Total Current Assets | $26,259 | $45,070 | | Total Assets | $41,207 | $99,406 | | Total Current Liabilities | $21,582 | $30,436 | | Total Liabilities | $25,826 | $35,921 | | Total Stockholders' Equity | $15,381 | $63,485 | [Consolidated Statements of Operations and Comprehensive Loss](index=182&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For FY2023, iBio reported a total net loss of **($65.0) million**, or **($5.31) per share**, primarily driven by a **($35.7) million** loss from discontinued operations Consolidated Statement of Operations Highlights (in thousands, except per share data) | Metric | FY 2023 | FY 2022 | | :--- | :--- | :--- | | Revenues (Continuing Operations) | $0 | $1,884 | | Operating Loss (Continuing Operations) | $(29,343) | $(29,697) | | Net Loss from Continuing Operations | $(29,311) | $(29,600) | | Loss from Discontinued Operations | $(35,699) | $(20,791) | | **Net Loss Available to Stockholders** | **$(65,010)** | **$(50,391)** | | Loss Per Share (Basic and Diluted) | $(5.31) | $(5.78) | [Consolidated Statements of Cash Flows](index=185&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved to **($30.4) million** in FY2023, while investing activities provided **$7.0 million**, resulting in a **($21.1) million** net decrease in cash, ending at **$7.6 million** Consolidated Cash Flow Highlights (in thousands) | Cash Flow Activity | FY 2023 | FY 2022 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | $(30,436) | $(37,480) | | Net Cash Provided by (Used in) Investing Activities | $7,009 | $(5,127) | | Net Cash Provided by (Used in) Financing Activities | $2,301 | $(6,125) | | **Net Decrease in Cash** | **$(21,093)** | **$(48,732)** | | Cash, Cash Equivalents and Restricted Cash - End of Period | $7,579 | $28,672 | [Notes to Consolidated Financial Statements](index=187&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail accounting policies, including going concern doubts, discontinued CDMO operations, the RubrYc asset acquisition, Woodforest term loan amendments, and capital raises - **Going Concern (Note 2):** The financial statements were prepared assuming the company will continue as a going concern, but recurring losses, negative cash flows, and limited cash raise substantial doubt about this ability; cash of **$7.6 million** at June 30, 2023, is not sufficient to fund operations through Q2 FY2024[585](index=585&type=chunk)[587](index=587&type=chunk) - **Discontinued Operations (Note 3):** The CDMO business is reported as a discontinued operation; in FY2023, this segment recorded a loss of **$35.7 million**, which included a **$17.9 million** fixed asset impairment charge and a **$4.9 million** inventory write-down[592](index=592&type=chunk) - **Significant Transactions (Note 6):** The acquisition of RubrYc assets was accounted for as an asset purchase with an allocated price of approximately **$1.34 million** plus assumed finance leases; the company also details the 2021 purchase of its Bryan, TX facility and subsequent financing[666](index=666&type=chunk)[652](index=652&type=chunk) - **Debt (Note 14):** The term loan with Woodforest Bank had a balance of **$12.9 million** as of June 30, 2023; the agreement has been amended six times, with the maturity date extended to December 31, 2023, contingent on the sale of the facility[701](index=701&type=chunk)[703](index=703&type=chunk) - **Stockholders' Equity (Note 17):** The company executed a **1-for-25 reverse stock split** on October 7, 2022; during FY2023, it raised approximately **$6.4 million** through at-the-market offerings and net proceeds of approximately **$2.9 million** from a public offering in December 2022[725](index=725&type=chunk)[726](index=726&type=chunk)[733](index=733&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___ to ___ Commission File Number 001-35023 iBio, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpora ...

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the unaudited financial statements, management's analysis of financial condition and operations, market risk disclosures, and internal controls [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited consolidated financial statements, reflecting a strategic pivot, significant losses, and substantial doubt about the company's going concern status [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet shows a significant decrease in total assets and stockholders' equity, primarily driven by reduced cash and asset reclassifications Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | Dec 31, 2022 (Unaudited) | June 30, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $3,696 | $22,676 | | Current assets held for sale | $20,457 | $3,900 | | Total Current Assets | $38,235 | $45,070 | | Total Assets | $51,800 | $99,406 | | **Liabilities & Equity** | | | | Total Current Liabilities | $27,775 | $30,436 | | Total Liabilities | $32,977 | $35,921 | | Total Stockholders' Equity | $18,823 | $63,485 | | Total Liabilities and Equity | $51,800 | $99,406 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statements of operations show no revenue from continuing operations, increased operating losses, and a substantial net loss due to discontinued operations Condensed Consolidated Statements of Operations (in thousands, except per share amounts) | Metric | Three Months Ended Dec 31, 2022 | Three Months Ended Dec 31, 2021 | Six Months Ended Dec 31, 2022 | Six Months Ended Dec 31, 2021 | | :--- | :--- | :--- | :--- | :--- | | Revenues (Continuing) | $0 | $0 | $0 | $84 | | Operating loss (Continuing) | $(10,573) | $(7,231) | $(18,209) | $(12,456) | | Loss from discontinued operations | $(22,990) | $(4,729) | $(33,583) | $(8,480) | | Net loss available to iBio, Inc. stockholders | $(33,553) | $(11,942) | $(51,683) | $(20,947) | | Loss per common share - total | $(3.42) | $(1.37) | $(5.54) | $(2.40) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow statements indicate increased cash usage in operations, a net decrease in cash, and a low ending cash balance Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended Dec 31, 2022 | Six Months Ended Dec 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(21,594) | $(20,033) | | Net cash used in investing activities | $(1,226) | $(6,121) | | Net cash used in financing activities | $(1,903) | $(6,105) | | **Net decrease in cash, cash equivalents and restricted cash** | **$(24,723)** | **$(32,259)** | | Cash, cash equivalents and restricted cash - beginning | $28,672 | $77,404 | | **Cash, cash equivalents and restricted cash - end** | **$3,949** | **$45,145** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's strategic pivot to AI-driven immunotherapy, the divestment of CDMO operations, and significant going concern doubts due to losses and limited cash - The company has shifted its focus to become an AI-driven innovator of precision antibody immunotherapies, with a pipeline focused on immuno-oncology antibodies against hard-to-drug targets[26](index=26&type=chunk) - The IND filing for IBIO-101 is delayed from the first half of 2024 to the first half of 2025 to await competitor clinical data and optimize financial resources[28](index=28&type=chunk) - The company has terminated its IBIO-100 anti-fibrotic program and the related license agreement with the University of Pittsburgh due to manufacturing challenges[34](index=34&type=chunk) - In September 2022, the company acquired substantially all assets of RubrYc Therapeutics, including its AI Drug Discovery platform, to enhance its antibody discovery capabilities[36](index=36&type=chunk)[118](index=118&type=chunk) - There is substantial doubt about the Company's ability to continue as a going concern due to significant losses and limited cash. Cash and investments of **$9.9 million** as of Dec 31, 2022, are not expected to be sufficient to support operations through Q3 Fiscal 2023 without additional financing or other measures[42](index=42&type=chunk)[43](index=43&type=chunk) - On November 3, 2022, the company announced the divestment of its CDMO business, leading to a **60% workforce reduction** and classifying the segment as a discontinued operation. This resulted in a charge of **$33.6 million** for the six months ended Dec 31, 2022, including a **$17.6 million fixed asset impairment**[46](index=46&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic transformation, severe liquidity challenges, increased operating expenses, and significant asset impairment charges [Overview and Recent Developments](index=35&type=section&id=Overview%20and%20Recent%20Developments) The company is transforming into an AI-driven immunotherapy innovator, marked by CDMO divestment, workforce reduction, an equity offering, and significant management changes - The company is transforming into an AI-driven precision antibody discovery and development company, planning to divest its CDMO business[229](index=229&type=chunk) - In conjunction with the divestment, the company reduced its workforce by approximately **60% (69 positions)**, which is expected to reduce the monthly burn rate by about half to a range of **$2.5-$3.0 million**[229](index=229&type=chunk) - In December 2022, the company closed an underwritten public offering, receiving net proceeds of approximately **$2.86 million**[231](index=231&type=chunk)[233](index=233&type=chunk) - The company experienced significant management turnover, with the CEO resigning in December 2022, followed by the appointment of an Interim CEO and Interim CFO in January 2023[230](index=230&type=chunk)[234](index=234&type=chunk) [Liquidity and Capital Resources](index=37&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces severe liquidity challenges, with insufficient cash to fund operations, raising substantial doubt about its ability to continue as a going concern - Management has concluded there is **substantial doubt** about the company's ability to continue as a going concern for the next 12 months[237](index=237&type=chunk) - Cash, cash equivalents, restricted cash and investments of **$9.9 million** as of December 31, 2022, are not anticipated to be sufficient to support operations through the third quarter of fiscal year 2023[239](index=239&type=chunk) - The company must raise additional capital to execute its long-term business plan, regardless of cost-cutting measures or asset sales[239](index=239&type=chunk) [Results of Operations](index=38&type=section&id=Results%20of%20Operations) Operating expenses from continuing operations increased, driven by R&D and G&A costs, with significant losses from discontinued operations due to asset impairments Comparison of Operating Expenses (in millions) | Expense Category | Three Months Ended Dec 31, 2022 | Three Months Ended Dec 31, 2021 | Six Months Ended Dec 31, 2022 | Six Months Ended Dec 31, 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and Development | $2.8 | $1.9 | $5.3 | $3.0 | | General and Administrative | $7.8 | $5.4 | $12.9 | $9.5 | | **Total Operating Expenses** | **$10.6** | **$7.2** | **$18.2** | **$12.5** | - The increase in G&A expenses for the three months ended Dec 31, 2022 was primarily due to severance-related expenses for the company's former CEO[243](index=243&type=chunk) - Losses from Discontinued Operations for the six months ended Dec 31, 2022 were approximately **$33.6 million**, including impairments of fixed assets (**$17.6 million**) and inventory (**$4.9 million**), and personnel costs including severance (**$5.8 million**)[251](index=251&type=chunk) [Critical Accounting Estimates](index=40&type=section&id=Critical%20Accounting%20Estimates) Critical accounting estimates include impairment of fixed assets and indefinite-lived intangible assets, with significant charges recorded for CDMO assets and ongoing risk for IBIO-101 IP - The decision to divest the CDMO triggered an impairment analysis, resulting in a **$17.6 million** charge (**$6.3 million** for the building, **$11.3 million** for machinery) in the quarter ended Dec 31, 2022[264](index=264&type=chunk)[265](index=265&type=chunk) - The IBIO-101 intangible asset (carrying amount of **$5 million**) was tested for impairment but none was recorded. It remains at risk for future impairment, with a hypothetical **16% discount rate** or a **35% probability** of clearing Phase 1 FDA approval potentially triggering a material charge[268](index=268&type=chunk)[269](index=269&type=chunk)[277](index=277&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, iBio, Inc. is not required to provide the information for this item - The company is a smaller reporting company and is not required to provide the information required by this Item[273](index=273&type=chunk) [Item 4. Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of December 31, 2022, with no material changes in internal control over financial reporting - Based on an evaluation as of December 31, 2022, the interim Principal Executive Officer and interim Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective**[275](index=275&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended December 31, 2022, that materially affected or are likely to materially affect internal controls[276](index=276&type=chunk) [PART II. OTHER INFORMATION](index=43&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, critical risk factors, recent corporate developments, and a list of exhibits filed with the report [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings that are expected to have a material adverse effect on its business - The company is not subject to any material legal proceedings[278](index=278&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) The company faces critical risks including substantial doubt about its going concern ability, need for additional capital, potential credit agreement default, asset impairment, and loss of CDMO revenue - There is **substantial doubt** about the company's ability to operate as a going concern, as cash of **$9.9 million** as of Dec 31, 2022, is not sufficient to support operations for the next 12 months without raising additional capital or further reducing its burn rate[281](index=281&type=chunk)[283](index=283&type=chunk) - The company needs additional funding to execute its business plan, and if unable to raise capital, it may be forced to delay, reduce, or eliminate development programs or cease operations[287](index=287&type=chunk)[289](index=289&type=chunk) - Failure to comply with the terms of the Woodforest Credit Agreement, particularly the liquidity covenant, could result in a **default**, acceleration of debt, and potential action against pledged assets, including the manufacturing facility[290](index=290&type=chunk)[291](index=291&type=chunk) - Acquired intangible assets may become impaired, requiring significant charges to earnings if circumstances change, such as sustained decreases in share price or negative developments in the pipeline[293](index=293&type=chunk) - The discontinuance of the CDMO business means the company will not generate material revenue from these operations going forward[297](index=297&type=chunk) - Recent turnover in the senior management team could adversely affect the business[298](index=298&type=chunk) [Item 5. Other Information](index=46&type=section&id=Item%205.%20Other%20Information) This section details the termination of the IBIO-100 license agreement and a second amendment to the Woodforest Credit Agreement, waiving a liquidity covenant default - On February 14, 2023, the company notified the University of Pittsburgh that it was terminating the license agreement for the IBIO-100 program, resulting in a full impairment of the related intangible asset of **$25,000**[300](index=300&type=chunk) - On February 9, 2023, the company and Woodforest entered into a Second Amendment to the Credit Agreement, which waived a default of the liquidity covenant, allowed certain equipment sales, and removed the obligation for iBio CDMO to continue its primary business[301](index=301&type=chunk) [Item 6. Exhibits](index=47&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the quarterly report, including corporate governance documents, agreements, and required certifications [SIGNATURES](index=48&type=section&id=SIGNATURES) The report is duly signed and authorized by the company's Principal Executive Officer and Interim Chief Financial Officer

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited Q3 2022 financial statements reflect a **$18.1 million** net loss, asset decline, and going concern uncertainty from strategic shifts [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of September 30, 2022, shows total assets at **$84.6 million**, a decrease driven by reduced cash and assets held for sale Condensed Consolidated Balance Sheet Highlights (in Thousands) | Account | September 30, 2022 (Unaudited) | June 30, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $9,887 | $22,676 | | Current assets held for sale | $38,778 | $3,900 | | Total Current Assets | $63,565 | $45,070 | | Total Assets | $84,564 | $99,406 | | **Liabilities & Equity** | | | | Total Current Liabilities | $32,199 | $30,436 | | Total Liabilities | $36,196 | $35,921 | | Total iBio, Inc. Stockholders' Equity | $48,368 | $63,485 | | Total Liabilities and Equity | $84,564 | $99,406 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q3 2022 operations show no continuing revenue, an increased operating loss of **$7.6 million**, and a **$10.6 million** loss from discontinued operations Statement of Operations Summary (in Thousands, except per share amounts) | Metric | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Revenues (Continuing Ops) | $0 | $84 | | Research and development | $2,548 | $1,134 | | General and administrative | $5,088 | $4,175 | | Operating loss (Continuing Ops) | ($7,636) | ($5,225) | | Loss from discontinued operations | ($10,593) | ($3,751) | | Net loss available to stockholders | ($18,130) | ($9,005) | | Loss per common share - total | ($2.05) | ($1.03) | [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in Q3 2022 operating activities increased to **$14.0 million**, leading to a **$12.8 million** overall decrease in cash and equivalents Cash Flow Summary (in Thousands) | Cash Flow Activity | Three Months Ended Sep 30, 2022 | Three Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($13,959) | ($9,347) | | Net cash provided by (used in) investing activities | $29 | ($5,149) | | Net cash provided by (used in) financing activities | $1,141 | ($88) | | **Net decrease in cash, cash equivalents and restricted cash** | **($12,789)** | **($14,584)** | | Cash, cash equivalents and restricted cash - end | $15,883 | $62,820 | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's transformation into an AI-driven immunotherapy firm, CDMO divestiture, workforce reduction, and going concern uncertainty - The company is now an AI-driven innovator of precision antibody immunotherapies with a pipeline focused on immuno-oncology[23](index=23&type=chunk) - Substantial doubt exists about the company's ability to continue as a going concern, with cash reserves of **$23.5 million** as of September 30, 2022, not anticipated to be sufficient to support operations beyond Q3 of Fiscal 2023[35](index=35&type=chunk) - In November 2022, the company announced the divestiture of its CDMO business (iBio CDMO, LLC) and a corresponding **60%** workforce reduction to transform into an antibody discovery and development company[38](index=38&type=chunk) - In September 2022, iBio acquired substantially all assets of RubrYc Therapeutics, including its AI Drug Discovery platform, for approximately **$1.34 million** plus potential milestone payments[30](index=30&type=chunk)[104](index=104&type=chunk)[105](index=105&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's strategic shift to AI-driven immunotherapy, operational losses, and critical liquidity challenges raising going concern doubts [Overview and Recent Developments](index=31&type=section&id=Overview%20and%20Recent%20Developments) Recent developments include the company's repositioning as an AI-driven immunotherapy firm, CDMO divestiture, and a **60%** workforce reduction - The company is transforming into an AI-driven antibody discovery and development company by divesting its CDMO business[191](index=191&type=chunk) - A workforce reduction of approximately **60%** (**69 positions**) was initiated, which is expected to reduce the monthly cash burn rate by about **50%** to a range of **$2.5-$3.0 million**[193](index=193&type=chunk) - The credit agreement with Woodforest was amended, requiring principal payments and reducing the liquidity covenant from **$10 million** to **$7.5 million**, with a potential further reduction to **$5.0 million**[190](index=190&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) Q3 2022 results show no continuing revenue, increased R&D and G&A expenses, and a significant **$10.6 million** loss from discontinued operations Comparison of Operating Results (in millions) | Expense Category | Q1 FY2023 (ended Sep 30, 2022) | Q1 FY2022 (ended Sep 30, 2021) | Change | | :--- | :--- | :--- | :--- | | Revenue (Continuing Ops) | $0.0 | $0.1 | ($0.1) | | Research & Development | $2.5 | $1.1 | +$1.4 | | General & Administrative | $5.1 | $4.2 | +$0.9 | | Loss from Discontinued Ops | ($10.6) | ($3.8) | ($6.8) | - The increased loss from discontinued operations was primarily due to a **$4.1 million** write-off of consumables and inventory[201](index=201&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2022, the company's **$23.5 million** cash position is insufficient for future operations, raising going concern doubts - Cash, cash equivalents, and debt securities totaled **$23.5 million** as of September 30, 2022[203](index=203&type=chunk) - Current cash is not anticipated to be sufficient to support operations beyond Q3 of Fiscal 2023, raising substantial doubt about the company's ability to continue as a going concern[204](index=204&type=chunk)[208](index=208&type=chunk) - The company plans to fund future operations through cash on hand, proceeds from the CDMO sale, asset out-licensing, and raising additional equity or other securities[208](index=208&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=35&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exempt from market risk disclosures due to its status as a smaller reporting company - The company is exempt from this disclosure requirement due to its status as a smaller reporting company[214](index=214&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of September 30, 2022, with no material changes to internal controls - Management concluded that disclosure controls and procedures were effective as of September 30, 2022[217](index=217&type=chunk) - No material changes were made to the company's internal control over financial reporting during the quarter ended September 30, 2022[218](index=218&type=chunk) [PART II. OTHER INFORMATION](index=36&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - As of the reporting date, the company is not involved in any material legal proceedings[219](index=219&type=chunk) [Item 1A. Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) Significant risks include financial viability concerns, going concern uncertainty, and the critical need for additional funding to sustain operations - The company's cash position of **$23.5 million** as of September 30, 2022, is not sufficient to support operations for at least 12 months, raising substantial doubt about its ability to continue as a going concern[222](index=222&type=chunk)[224](index=224&type=chunk) - The company is undertaking a strategic review, including selling its CDMO business and reducing its workforce by **60%**, to extend its cash runway, but there is no assurance of success[221](index=221&type=chunk) - Additional funding is required to execute the long-term business plan; if unable to raise capital, the company may be forced to delay, reduce, or eliminate programs, or cease operations[228](index=228&type=chunk)[230](index=230&type=chunk) [Item 5. Other Information](index=38&type=section&id=Item%205.%20Other%20Information) The company granted performance-based RSUs to its CEO, CFO, and CSO in November 2022 as retention incentives - On November 10, 2022, CEO Thomas F. Isett was granted RSUs for **200,000 shares** with performance-based vesting conditions tied to IND submission, CDMO disposition, or out-licensing[235](index=235&type=chunk) - On November 11, 2022, CFO Robert Lutz and CSO Martin Brenner were granted RSUs for **100,057** and **95,348 shares**, respectively, as retention incentives to remain with the company through July 1, 2023[236](index=236&type=chunk)[237](index=237&type=chunk) [Item 6. Exhibits](index=38&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents and material agreements

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___ to ___ Commission file number 001-35023 iBio, Inc. (Exact name of registrant as specified in its charter) Delaware 26-2797813 (State or other jurisdiction o ...

iBio, Inc. (NYSE:IBIO) Q4 2022 Earnings Conference Call September 27, 2022 4:30 PM ET Company Participants Stephen Kilmer - Investor Relations Tom Isett - Chairman and Chief Executive Officer Rob Lutz - Chief Financial and Business Officer Martin Brenner - Chief Scientific Officer Conference Call Participants Kristen Kluska - Cantor Roy Buchanan - JMP Securities Operator Thank you for standing. And welcome to the iBio Fiscal Year 2022 Results Conference Call. At this time, all participants are in a listen-o ...

iBlo Growing Tomorrow's Biologics CORPORATE PRESENTATION May 2022 Tom Isett, Chairman & CEO © 2022 iBio, Inc. All Rights Reserved. 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 s ...

iBio, Inc. (NYSE:IBIO) Q3 2022 Results Conference Call May 12, 2022 4:30 PM ET Company Participants Stephen Kilmer - Investor Relations Tom Isett - Chairman and Chief Executive Officer Rob Lutz - Chief Financial and Business Officer Conference Call Participants Roy Buchanan - JMP Securities Operator Good day and thank you for standing. Welcome to the iBio Fiscal 2022 Third Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, t ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Table of Contents For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___ to ___ Commission file number 001-35023 iBio, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorpora ...

Financial Data and Key Metrics Changes - Revenues for Q2 2022 were approximately $200,000, a decrease of 76% compared to Q2 2021 [29] - R&D and G&A expenses increased by 40% and 48% respectively over the same period, reflecting the company's growing investment in its pipeline and infrastructure [30][31] - As of December 31, 2021, the company had $57.4 million in cash and marketable securities, excluding $5.9 million in restricted cash, which is expected to support activities through September 30, 2023 [32] Business Line Data and Key Metrics Changes - The company added six new immunooncology assets to its pipeline in six months, demonstrating significant progress in drug discovery [15][23] - The latest candidate, a monoclonal antibody, has progressed rapidly through the development stages due to its high-quality design [16] Market Data and Key Metrics Changes - The company is focusing on developing a nucleocapsid protein subunit vaccine (IBIO-202) to address issues with durability and variant inclusion, which are unmet needs in the current vaccine market [6][10] Company Strategy and Development Direction - The company aims to deliver a last COVID vaccine dose rather than just the next dose, with plans to file an IND application by the end of the calendar year [34] - iBio is exploring alternative delivery methods for its vaccines, including microarray patch delivery systems, to enhance accessibility and reduce logistical challenges [12][76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of their biopharmaceutical development capabilities and the potential for revenue growth in the second half of fiscal 2022 [30][34] - The company is committed to addressing unmet medical needs in oncology and is optimistic about the efficacy study results for its therapeutic candidates [34] Other Important Information - iBio has acquired full control of its manufacturing facility and CDMO subsidiary, which is expected to enhance operational efficiency and scalability [31] - The company is actively evaluating opportunities for government contracts related to next-generation COVID-19 vaccines [73] Q&A Session Summary Question: Insights on oncology targets and validation - Management highlighted the focus on well-validated targets while also addressing the challenges of engineering antibodies for maximal efficacy and safety [38][42] Question: Precision medicine approaches in oncology - The company aims to develop broadly applicable solutions while also considering precision medicine for rare cancers, leveraging its FastPharming platform for efficient production [45][46] Question: Status of IBIO-202 and challenge studies - Management confirmed that planning for challenge studies is underway, with a focus on T-cell responses due to the nature of the nucleocapsid protein [60][62] Question: Financial guidance and manufacturing facility - The company is maintaining conservative financial guidance and confirmed full ownership of the CDMO business, with no plans for resale [64][65] Question: Update on COVID-19 vaccine efforts and delivery methods - Management clarified that they are pursuing both IND-enabling studies and alternative delivery methods simultaneously, emphasizing the feasibility of microarray patch technologies [75][76] Question: Confidentiality regarding the Fraunhofer settlement - Management indicated that while some details remain confidential, financial specifics related to the settlement are available in filings, including expected cash payments [78][80]