[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]

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited financial statements for December 31, 2021, reflect decreased total assets, increased net losses, and significant cash usage from operations compared to prior periods [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of December 31, 2021, shows a decline in total assets, primarily cash, and a corresponding decrease in total equity Balance Sheet Highlights (In Thousands) | Balance Sheet Highlights (In Thousands) | Dec 31, 2021 | June 30, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $39,205 | $77,404 | | Total Current Assets | $67,496 | $104,597 | | Total Assets | $126,448 | $146,968 | | **Liabilities & Equity** | | | | Total Current Liabilities | $8,346 | $6,645 | | Total Liabilities | $35,850 | $38,400 | | Total Equity | $90,598 | $108,568 | [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 a significant decline in revenues and a widening net loss for both the three and six months ended December 31, 2021 Statement of Operations (In Thousands, except per share) | Statement of Operations (In Thousands, except per share) | Three Months Ended Dec 31, 2021 | Three Months Ended Dec 31, 2020 | | :--- | :--- | :--- | | Revenues | $168 | $705 | | Gross profit | $55 | $494 | | Research and development | $3,331 | $2,374 | | General and administrative | $8,362 | $5,665 | | Operating loss | $(11,638) | $(7,545) | | Net loss attributable to iBio, Inc. stockholders | $(11,942) | $(8,194) | | Loss per common share - basic and diluted | $(0.05) | $(0.04) | Statement of Operations (In Thousands, except per share) | Statement of Operations (In Thousands, except per share) | Six Months Ended Dec 31, 2021 | Six Months Ended Dec 31, 2020 | | :--- | :--- | :--- | | Revenues | $379 | $1,115 | | Gross profit | $226 | $797 | | Operating loss | $(20,612) | $(14,469) | | Net loss attributable to iBio, Inc. stockholders | $(20,947) | $(15,793) | | Loss per common share - basic and diluted | $(0.10) | $(0.09) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow statements for the six months ended December 31, 2021, indicate increased cash usage across operating, investing, and financing activities Cash Flow Summary (In Thousands) | Cash Flow Summary (In Thousands) | Six Months Ended Dec 31, 2021 | Six Months Ended Dec 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(20,033) | $(15,489) | | Net cash used in investing activities | $(6,121) | $(19,556) | | Net cash provided by (used in) financing activities | $(6,105) | $71,185 | | Net (decrease) increase in cash, cash equivalents and restricted cash | $(32,259) | $36,140 | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes detail business segments, accounting policies, significant transactions including a facility acquisition, and management's liquidity outlook - The company operates in two segments: Biopharmaceuticals (developing therapeutics for fibrotic diseases, oncology, and vaccines) and Bioprocessing (providing CDMO services and research products)[30](index=30&type=chunk) - Management believes its cash, cash equivalents, and investments in debt securities of approximately **$57.4 million** as of December 31, 2021, are adequate to support activities through at least September 30, 2023[43](index=43&type=chunk) - On November 1, 2021, the company acquired its 130,000 sq-ft cGMP manufacturing facility in Bryan, Texas, from affiliates of Eastern Capital Limited, terminated all related agreements, and made its subsidiary iBio CDMO wholly owned[90](index=90&type=chunk)[92](index=92&type=chunk) - The facility acquisition was financed in part by a **$22.375 million** secured term loan from Woodforest National Bank, with principal due on November 1, 2023[95](index=95&type=chunk) - In August 2021, the company entered into a collaboration and license agreement with RubrYc Therapeutics to develop immuno-oncology antibodies and made a **$5 million** equity investment in RubrYc's Series A-2 preferred stock, with a commitment for an additional **$2.5 million**[106](index=106&type=chunk)[119](index=119&type=chunk) - On July 21, 2021, the company was granted full forgiveness for its **$600,000** Paycheck Protection Program (PPP) loan[150](index=150&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes the company's financial performance, highlighting decreased revenue, increased operating expenses, widened net losses, and strategic developments [Recent Developments](index=38&type=section&id=Recent%20Developments) Recent developments include advancing vaccine and antibody candidates, expanding the oncology pipeline, and acquiring the Bryan, Texas manufacturing facility - The company plans to file an IND application for its **IBIO-202** nucleocapsid-based COVID-19 vaccine candidate before the end of calendar 2022[233](index=233&type=chunk) - The IL-2 sparing anti-CD25 antibody program, **IBIO-101**, is expected to move from lead optimization to the IND-enabling stage before mid-2022[236](index=236&type=chunk) - On November 1, 2021, iBio purchased its manufacturing facility, which it had previously leased, for a total price of **$28.75 million**, paid with **$28 million** in cash and a warrant[247](index=247&type=chunk) - The facility purchase was partly funded by a **$22.375 million** secured term loan from Woodforest National Bank, with principal due November 1, 2023[247](index=247&type=chunk) [Results of Operations](index=41&type=section&id=Results%20of%20Operations) Operating results show a significant decline in revenue and increased R&D and G&A expenses, leading to a widened net loss for the periods Financial Comparison (In Millions) | Financial Comparison (In Millions) | Three Months Ended Dec 31, 2021 | Three Months Ended Dec 31, 2020 | | :--- | :--- | :--- | | Revenue | $0.2 | $0.7 | | Gross Profit | $0.1 | $0.5 | | R&D Expenses | $3.3 | $2.4 | | G&A Expenses | $8.4 | $5.7 | | Net Loss | $(12.0) | $(8.2) | Financial Comparison (In Millions) | Financial Comparison (In Millions) | Six Months Ended Dec 31, 2021 | Six Months Ended Dec 31, 2020 | | :--- | :--- | :--- | | Revenue | $0.4 | $1.1 | | Gross Profit | $0.2 | $0.8 | | R&D Expenses | $5.8 | $4.2 | | G&A Expenses | $15.0 | $11.0 | | Net Loss | $(20.9) | $(15.7) | [Liquidity and Capital Resources](index=43&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity decreased to **$57.4 million** as of December 31, 2021, with management projecting sufficiency through September 2023 - The company's cash, cash equivalents, and debt securities totaled approximately **$57.4 million** as of December 31, 2021, excluding **$5.9 million** of restricted cash[270](index=270&type=chunk) - Management believes the current cash position is sufficient to fund company activities through at least September 30, 2023[270](index=270&type=chunk)[275](index=275&type=chunk) - For the six months ended Dec 31, 2021, cash usage was primarily driven by funding the net loss (**$20.0 million** from operations), asset purchases (**$6.1 million** from investing), and finance lease payments related to the facility purchase (**$6.1 million** from financing)[271](index=271&type=chunk)[272](index=272&type=chunk)[273](index=273&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, iBio, Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[282](index=282&type=chunk) [Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of December 31, 2021, with no material changes in internal control - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of December 31, 2021[286](index=286&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended December 31, 2021, that have materially affected, or are reasonably likely to materially affect, internal controls[287](index=287&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings as of the filing date - As of the filing date, the company is not subject to any material legal proceedings[289](index=289&type=chunk) [Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) Key risks include a history of significant losses, the need for additional capital, limited authorized shares, potential loan default, and dependence on license agreements - The company has a history of significant losses, with an accumulated deficit of approximately **$194.5 million** as of December 31, 2021, and expects to incur further losses[291](index=291&type=chunk) - Additional capital is needed to fully implement the long-term business plan. Failure to raise funds could force delays or elimination of R&D programs and commercialization efforts[295](index=295&type=chunk) - The limited number of authorized and unissued shares of common stock (approximately **21 million** as of Dec 31, 2021) may be insufficient for future equity financing or strategic transactions[299](index=299&type=chunk)[300](index=300&type=chunk) - The company faces risks related to its **$22.375 million** term loan, including the ability to make the principal payment and potential default, which could result in the loss of its sole manufacturing facility[306](index=306&type=chunk) - The business depends on maintaining license agreements, such as with the University of Pittsburgh for **IBIO-100**, which requires meeting specific developmental milestones, including filing an IND by December 31, 2023[309](index=309&type=chunk) [Other Information](index=49&type=section&id=Item%205.%20Other%20Information) The company amended its license agreement with the University of Pittsburgh, extending key clinical development and regulatory milestone deadlines - On February 2, 2022, the company amended its license agreement with the University of Pittsburgh, extending key milestone deadlines for its fibrosis program[313](index=313&type=chunk) - The amended milestone deadlines include filing an IND by December 31, 2023, and enrolling the first patient in a Phase 1 trial by June 30, 2024[314](index=314&type=chunk) [Exhibits](index=50&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate documents, loan agreements, and officer certifications

iBio, Inc. (NYSE:IBIO) Q3 2021 Earnings Conference Call November 16, 2021 4:30 PM ET Company Participants Stephen Kilmer – Investor Relations Thomas Isett – Chairman and Chief Executive Officer Martin Brenner – Chief Scientific Officer Randy Maddux – Chief Operating Officer Robert Lutz – Chief Financial and Business Officer Conference Call Participants Kristen Kluska – Cantor Fitzgerald Norman Carlyle – Private investor Philip Barnett – Shareholder David Sandrock – Private Investor Operator Good day and tha ...