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 ...

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 September 30, 2021 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 incor ...

PART I [Business](index=4&type=section&id=Item%201.%20Business) iBio, Inc, a biopharmaceutical company, develops biologics using its plant-based FastPharming Manufacturing System® and operates through Biopharmaceuticals and Bioprocessing segments [Business Overview and Segments](index=4&type=section&id=Business%20Overview%20and%20Segments) iBio develops biopharmaceuticals using its sustainable FastPharming Manufacturing System® and operates through its Biopharmaceuticals and Bioprocessing segments - The company is structured into two main operating segments: **Biopharmaceuticals** and **Bioprocessing**[10](index=10&type=chunk) - The Biopharmaceuticals segment includes Therapeutics (oncology, fibrotic, infectious diseases) and Vaccines (human and animal health)[10](index=10&type=chunk) - The Bioprocessing segment includes Services (FastPharming, Process Development, Manufacturing) and Products (growth factors, lectins, antibodies for research)[10](index=10&type=chunk) [Biopharmaceutical Segment](index=4&type=section&id=Biopharmaceutical%20Segment) The Biopharmaceutical segment advances a proprietary pipeline including candidates for fibrosis (IBIO-100), oncology (IBIO-101), COVID-19 (IBIO-202), and Classical Swine Fever (IBIO-400) - The lead anti-fibrotic candidate, **IBIO-100**, has been granted orphan drug designation by the FDA for the treatment of systemic scleroderma[18](index=18&type=chunk) - In August 2021, the company licensed RTX-003 from RubrYc Therapeutics, an anti-CD25 monoclonal antibody for oncology, which will be advanced as **IBIO-101**[20](index=20&type=chunk)[23](index=23&type=chunk) - The company is developing **IBIO-202**, a subunit vaccine candidate for COVID-19 that targets the Nucleocapsid (N) protein, which is more conserved than the Spike (S) protein[30](index=30&type=chunk) - **IBIO-400** is a DIVA-capable subunit vaccine candidate for Classical Swine Fever that has shown complete protection in challenged pigs after a single dose[34](index=34&type=chunk)[35](index=35&type=chunk) [Bioprocess Segment](index=8&type=section&id=Bioprocess%20Segment) The Bioprocess segment provides contract development and manufacturing (CDMO) services and sells research and bioprocess products, with CDMO revenue growing 50% in fiscal 2021 CDMO Service Revenue | Fiscal Year | Revenue (in millions) | Year-over-Year Growth | | :--- | :--- | :--- | | 2021 | $2.4 | 50% | | 2020 | $1.6 | - | - The company launched its Research & Bioprocess Products (RBP) business during the fiscal year, offering recombinant proteins through a new e-shop[38](index=38&type=chunk) [FastPharming Technology](index=9&type=section&id=FastPharming%20Technology) FastPharming is a proprietary, plant-based protein production system offering advantages in speed, cost, quality, scalability, safety, and sustainability over traditional methods - The FastPharming System uses transiently-transfected Nicotiana benthamiana plants for protein production[41](index=41&type=chunk) - Key advantages of FastPharming include **speed** (weeks vs months), **cost-effectiveness**, **quality**, **scalability**, **safety** (no mammalian virus risk), and **sustainability**[43](index=43&type=chunk) - The system is established in iBio's **130,000 square foot facility** in Bryan, Texas, which houses automated hydroponic systems capable of growing over four million plants[42](index=42&type=chunk)[71](index=71&type=chunk) [Strategic Alliances, Collaborations, and Joint Ventures](index=10&type=section&id=Strategic%20Alliances%2C%20Collaborations%2C%20and%20Joint%20Ventures) The company leverages strategic alliances, including a key collaboration with RubrYc Therapeutics for its oncology pipeline and an exclusive license with the University of Pittsburgh - Entered into a series of agreements with RubrYc Therapeutics in August 2021, including an exclusive license for RTX-003, a collaboration for antibody discovery, and a **$5 million stock purchase** in RubrYc[51](index=51&type=chunk)[55](index=55&type=chunk)[60](index=60&type=chunk) - Holds an exclusive worldwide license from the University of Pittsburgh for endostatin peptides used in its IBIO-100 anti-fibrosis program, with specific development milestones required[64](index=64&type=chunk)[65](index=65&type=chunk) - The company's Bryan, Texas manufacturing facility is operated through iBio CDMO, a joint venture in which iBio holds a **99.99% interest**, with an affiliate of Eastern Capital Limited holding the remaining interest and acting as the sublandlord[68](index=68&type=chunk)[69](index=69&type=chunk) - Terminated its partnership with Planet Biotechnologies for the development of a recombinant ACE2-Fc protein for COVID-19[67](index=67&type=chunk) [Intellectual Property](index=15&type=section&id=Intellectual%20Property) The company's intellectual property portfolio consists of 102 patents, with expiration dates ranging from 2023 to 2036, covering its core technologies and product candidates Patent Portfolio Summary | Category | Count | | :--- | :--- | | Total Patents | 102 | | - Owned | 96 | | - Licensed | 6 | | U.S. Patents | 24 | | International Patents | 72 | - Patents expire between **2023 and 2036**[72](index=72&type=chunk) - Patented technologies include methods for transient gene expression in plants, recombinant carrier molecules, and specific antigens and vaccine compositions for various diseases[77](index=77&type=chunk) [Competition](index=16&type=section&id=Competition) iBio faces intense competition from large pharmaceutical companies, specialized biotech firms, and other contract manufacturers in its therapeutic and CDMO markets - The company competes with commercial pharmaceutical and biotech enterprises, academic institutions, and research institutions[80](index=80&type=chunk) - In the CDMO market, competition comes from full-service contract manufacturers and large pharmaceutical companies with excess capacity[81](index=81&type=chunk) - Key competitors in oncology and fibrosis include large, multinational biopharmaceutical companies such as **Roche**, **Boehringer Ingelheim**, **Gilead**, and **Bristol-Myers Squibb**[85](index=85&type=chunk)[86](index=86&type=chunk) - In the COVID-19 space, the company faces competition from established vaccine manufacturers like **Pfizer**, **Moderna**, and **AstraZeneca**, with over 231 vaccines and 612 therapeutics in development globally[87](index=87&type=chunk) [Government Regulation and Product Approval](index=18&type=section&id=Government%20Regulation%20and%20Product%20Approval) The company's products and services are subject to extensive regulation by the FDA and similar authorities, requiring a lengthy and rigorous approval process - Pharmaceutical products require rigorous preclinical testing and multi-phase clinical trials before they can be marketed, a process overseen by the FDA[93](index=93&type=chunk)[94](index=94&type=chunk) - The clinical trial process typically involves three sequential phases: **Phase 1** (safety), **Phase 2** (preliminary efficacy and dosage), and **Phase 3** (large-scale efficacy and safety)[98](index=98&type=chunk)[101](index=101&type=chunk)[105](index=105&type=chunk) - The company's CDMO facility is subject to FDA regulation and must comply with cGMPs, as well as environmental, health, and safety laws[118](index=118&type=chunk)[120](index=120&type=chunk) - The Orphan Drug Act may provide benefits like market exclusivity for products treating rare diseases affecting fewer than 200,000 individuals in the U.S[112](index=112&type=chunk) [Human Capital](index=23&type=section&id=Human%20Capital) As of June 30, 2021, the company had 75 employees and plans to expand its workforce in Fiscal 2022 to support growth objectives Employee Headcount as of June 30, 2021 | Entity | Employee Count | | :--- | :--- | | iBio, Inc. | 18 | | iBio CDMO | 57 | | **Total** | **75** | - The company plans to hire additional staff in Fiscal 2022 to meet growth objectives for its therapeutic, vaccine, and RBP product development[121](index=121&type=chunk) - Compensation programs include competitive wages, incentive pay, and a 401(k) plan with a **100% match** on employee contributions up to 5% of compensation[130](index=130&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including a history of financial losses, the need for additional capital, uncertainties in product development, and reliance on third parties - The company has a history of significant losses, with a **net loss of $23.2 million** in FY 2021 and an **accumulated deficit of $173.6 million** as of June 30, 2021[142](index=142&type=chunk) - The business depends on the success of its four product candidates, which are all in early stages of pre-clinical development and require significant testing before seeking regulatory approval[165](index=165&type=chunk) - The company's license agreement with the University of Pittsburgh for its lead fibrosis candidate, IBIO-100, contains specific milestone deadlines that it may not meet, potentially jeopardizing the license[247](index=247&type=chunk) - Operations are reliant on a single manufacturing facility in Texas, making the company vulnerable to disruptions from natural disasters, equipment failure, or other unforeseen events[265](index=265&type=chunk) - The company may not have a sufficient number of authorized shares of common stock for future equity financings or strategic transactions, which could impede growth[155](index=155&type=chunk)[156](index=156&type=chunk) [Property](index=58&type=section&id=Item%202.%20Property) iBio's primary operations are conducted at a 130,000-square-foot leased manufacturing facility in Texas and a newly leased R&D facility in California - The main facility is a **130,000 sq. ft.** Class A life sciences building in Bryan, Texas, leased until 2050[302](index=302&type=chunk) - The Bryan facility lease requires an annual base rent of **$2.1 million**, plus a tiered percentage of gross sales, with minimums applicable if sales targets are not met[303](index=303&type=chunk)[306](index=306&type=chunk) - A new lease was signed in September 2021 for approximately **11,383 sq. ft.** of lab and office space in San Diego, CA, to be used for R&D[307](index=307&type=chunk) [Legal Proceedings](index=59&type=section&id=Item%203.%20Legal%20Proceedings) In May 2021, iBio settled its litigation with Fraunhofer USA, Inc, resulting in a total cash payment of $28 million to the company - On May 4, 2021, the company entered into a settlement agreement with Fraunhofer USA, Inc. to resolve all claims in a lawsuit initiated in March 2015[308](index=308&type=chunk) - The settlement terms include cash payments to iBio totaling **$28 million**, with an estimated net cash recovery of approximately **$10.2 million** after legal fees and expenses[309](index=309&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=60&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the NYSE American under the symbol "IBIO", and the company has never paid cash dividends on its common stock - The company's common stock trades on the NYSE American under the symbol **'IBIO'**[314](index=314&type=chunk) - **No cash dividends** have ever been declared or paid on common stock[315](index=315&type=chunk) - Accrued dividends on the Preferred Tracking Stock totaled approximately **$1,131,000** at June 30, 2021[316](index=316&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=60&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For fiscal year 2021, revenue increased 50% to $2.4 million, but a sharp rise in operating expenses led to a net loss of $23.2 million, while the cash position strengthened to $97.0 million [Results of Operations](index=61&type=section&id=Results%20of%20Operations) In fiscal 2021, revenue grew 50%, but surging R&D and G&A expenses widened the operating loss, partially offset by a significant legal settlement Fiscal Year 2021 vs. 2020 Results of Operations (in millions) | Metric | FY 2021 | FY 2020 | Change | | :--- | :--- | :--- | :--- | | Revenue | $2.4 | $1.6 | +50% | | R&D Expenses | $10.0 | $3.6 | +$6.4 | | G&A Expenses | $22.0 | $11.4 | +$10.6 | | Other Income (Expense) | $7.9 | ($2.4) | +$10.3 | - The increase in Other Income was primarily attributable to **$10.2 million** in settlement income from the Fraunhofer IP litigation[327](index=327&type=chunk) [Liquidity and Capital Resources](index=62&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2021, the company had $97.0 million in cash and investments, which is deemed sufficient to fund operations through the first quarter of calendar year 2023 - Cash and investments in debt securities totaled approximately **$97.0 million** as of June 30, 2021[330](index=330&type=chunk) - Management believes current cash is sufficient to support operations through the **first quarter of calendar year 2023**[330](index=330&type=chunk) Cash Flow Summary (in millions) | Activity | FY 2021 | FY 2020 | | :--- | :--- | :--- | | Net Cash Used in Operating | ($30.1) | ($13.3) | | Net Cash Used in Investing | ($26.5) | ($1.1) | | Net Cash Provided by Financing | $78.8 | $65.2 | - During fiscal 2021, the company raised approximately **$68.8 million** through an "At-The-Market" facility with UBS and approximately **$41.5 million** through offerings with Cantor Fitzgerald[334](index=334&type=chunk) [Controls and Procedures](index=64&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls, procedures, and internal control over financial reporting were effective as of June 30, 2021 - Management concluded that the company's disclosure controls and procedures were **effective** as of June 30, 2021[346](index=346&type=chunk) - Based on an assessment using the 2013 COSO Framework, management concluded that internal control over financial reporting was **effective** as of June 30, 2021[350](index=350&type=chunk)[351](index=351&type=chunk) - As a smaller reporting company, this report does not include an attestation report from the independent registered public accounting firm regarding internal control over financial reporting[353](index=353&type=chunk) [Other Information](index=65&type=section&id=Item%209B.%20Other%20Information) On September 23, 2021, the Board of Directors approved a significant cash bonus and stock option grant for the Chairman and CEO - On September 23, 2021, the Board awarded CEO Thomas Isett a cash bonus of **$509,000** and an option to purchase **2,000,000 shares** of common stock at an exercise price of $1.17 per share[354](index=354&type=chunk) PART III Information required for Part III is incorporated by reference from the company's definitive proxy statement for its 2021 Annual Meeting of Stockholders - Information for Items 10 through 14 is incorporated by reference from the definitive proxy statement for the 2021 Annual Meeting of Stockholders[356](index=356&type=chunk) PART IV This part contains the list of exhibits filed with the Form 10-K, including governance documents, material contracts, and certifications [Exhibits and Financial Statement Schedules](index=67&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section provides an index of all exhibits filed with or incorporated by reference into the Annual Report, including material contracts and governance documents - Lists all exhibits filed with the Form 10-K, including corporate governance documents, material agreements, and management compensation plans[368](index=368&type=chunk)[372](index=372&type=chunk)[375](index=375&type=chunk) Financial Statements [Consolidated Financial Statements](index=77&type=section&id=Consolidated%20Financial%20Statements) For fiscal year 2021, total assets grew significantly to $147.0 million, while the net loss widened to $23.2 million due to higher operating expenses Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2021 | June 30, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $77,404 | $55,112 | | Total Assets | $146,968 | $94,189 | | Total Liabilities | $38,400 | $37,582 | | Total Stockholders' Equity | $108,568 | $56,607 | Consolidated Statement of Operations Highlights (in thousands) | Account | FY 2021 | FY 2020 | | :--- | :--- | :--- | | Revenues | $2,371 | $1,638 | | Gross Profit | $909 | $935 | | Operating Loss | ($31,111) | ($14,003) | | Net Loss Attributable to iBio, Inc. | ($23,207) | ($16,439) | | Loss Per Share | ($0.12) | ($0.61) | Consolidated Statement of Cash Flows Highlights (in thousands) | Account | FY 2021 | FY 2020 | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($30,064) | ($13,345) | | Net Cash Used in Investing Activities | ($26,478) | ($1,154) | | Net Cash Provided by Financing Activities | $78,835 | $65,192 | | Net Increase in Cash | $22,292 | $50,691 | [Notes to Consolidated Financial Statements](index=82&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) The notes detail the company's accounting policies, segment information, lease obligations, significant equity transactions, and the financial impact of a major legal settlement - The company's revenue is primarily from fixed-fee contracts, recognized at a point in time upon completion of deliverables; in FY2021, **$2.371 million** was recognized at a point in time[432](index=432&type=chunk)[434](index=434&type=chunk) - The company's finance lease for its Bryan, TX facility has a remaining term of **28.58 years** with a weighted average discount rate of 7.606%; total future minimum lease payments amount to **$79.2 million**[494](index=494&type=chunk)[495](index=495&type=chunk) - In May 2021, the company settled litigation with Fraunhofer USA, resulting in a settlement income of **$10.2 million** and a total settlement receivable of the same amount[575](index=575&type=chunk)[577](index=577&type=chunk) - Subsequent to year-end, in August 2021, the company entered into a collaboration, license, and stock purchase agreement with RubrYc Therapeutics, investing **$5 million**[612](index=612&type=chunk)[621](index=621&type=chunk)