Company Overview - iBio Inc is a biotech company leveraging AI and advanced computational biology to develop next-generation biopharmaceuticals for cardiometabolic diseases, obesity, cancer, and other hard-to-treat diseases [1] - The company combines proprietary 3D modeling with innovative drug discovery platforms to create a pipeline of breakthrough antibody treatments [1] - iBio's mission is to transform drug discovery, accelerate development timelines, and unlock new possibilities in precision medicine [1] Recent Developments - iBio announced the closing of a private placement offering with members of its Board of Directors and Officers, totaling over $650,000 [3] - The investments from the Board of Directors underscore their confidence and support in iBio's strategy to advance as a clinical-stage biotech focused on developing therapeutics for cardiometabolic diseases, obesity, and other challenging diseases [4] Pipeline and Technology - iBio is building an innovative pipeline of therapeutics in cardiometabolic disease and obesity that aims to promote healthy weight loss [6] - The company's breakthrough antibody treatments are designed to reduce obesity while preserving muscle mass, promoting muscle growth, and preventing weight regain [6] - iBio's machine-learning-based drug discovery platform is driving the development of these candidates, which are being engineered for high developability and an extended half-life potentially enabling reduced dosing than current obesity therapeutics [6] Forward-Looking Statements - The press release contains forward-looking statements regarding iBio's innovative pipeline of therapeutics in cardiometabolic disease and obesity, including their potential to promote healthy weight loss and address significant unmet medical needs [5] - These statements are based on current estimates and assumptions and are subject to various risks and uncertainties [5]

Core Insights - iBio, Inc. has successfully closed a private placement offering totaling over $650,000 with its Board of Directors and Officers, indicating strong internal support for the company's strategic direction [1][2] Company Overview - iBio is an AI-driven biotech company focused on developing precision antibody immunotherapies for cardiometabolic diseases, obesity, cancer, and other challenging diseases [4] - The company utilizes advanced computational biology and proprietary 3D modeling to create a pipeline of innovative therapeutics aimed at addressing significant unmet medical needs [4] Product Pipeline - iBio is developing a pipeline of therapeutics specifically targeting cardiometabolic diseases and obesity, with a focus on promoting healthy weight loss [3] - The antibody treatments are designed to reduce obesity while preserving muscle mass, promoting muscle growth, and preventing weight regain [3] - The company's machine-learning-based drug discovery platform is aimed at creating candidates with high developability and an extended half-life, potentially allowing for reduced dosing compared to current obesity therapeutics [3]

Core Insights - iBio, Inc. has developed an antibody that inhibits Activin E, a significant therapeutic target for cardiometabolic disorders and obesity, showcasing the potential of its AI-driven drug discovery platform [1][2][3] - The achievement is considered an industry first and strengthens iBio's pipeline for innovative therapeutics aimed at addressing high unmet medical needs in cardiometabolic health [2][4] Company Developments - iBio's Machine-Learning Antibody Engine successfully identified five critical epitope regions on the Activin E protein, enabling the development of synthetic epitopes and antibodies without the need to produce Activin E itself [2][3] - Preclinical studies indicate strong antibody binding to Activin E, demonstrating sub-nanomolar kinetics and complete blockade of its signaling in human adipocytes, which is crucial for metabolic health [3] - iBio has entered a collaboration with AstralBio, granting AstralBio an exclusive license to engineer four targets for cardiometabolic disease, while iBio retains the option to license three targets from AstralBio [4][5] Industry Context - Activin E is supported as a promising therapeutic target based on human genetics, with individuals having a protective mutation in the INHBE gene showing a healthier cardiometabolic profile [2] - The current GLP-1 class of therapeutics has limitations, highlighting the need for next-generation solutions that can effectively address obesity and its associated health risks [3] - The collaboration between iBio and AstralBio aims to accelerate the development of novel therapeutics for cardiometabolic diseases, leveraging advanced technology for rapid progress [5][6]

Financial Results Announcement - iBio, Inc. announced its financial results for the quarter ended September 30, 2024[4]. - The press release detailing the financial results was issued on November 12, 2024[4]. Company Information - The company is listed on NYSE American under the trading symbol IBIO[2]. - iBio, Inc. is not classified as an emerging growth company[3]. Regulatory Information - The financial information provided is not deemed "filed" under the Securities Exchange Act of 1934[5]. - The report was signed by Marc A. Banjak, Chief Legal Officer of iBio, Inc.[7].

Company Overview - iBio, Inc. is a preclinical stage biotechnology company focused on developing precision antibodies using AI and machine learning technologies[200]. - The company aims to become a preferred partner for pharmaceutical companies by leveraging its AI platform to streamline biologic drug discovery[207]. - iBio is exploring partnerships in diverse therapeutic areas, including CNS and vaccines, to license its AI technology and enhance biological insights[209]. Technology and Innovation - The company has developed EngageTx™ technology for targeting bi-specific molecules, enhancing preclinical safety assessments[201]. - iBio's ShieldTx™ technology allows antibodies to remain inactive until they reach diseased tissue, potentially improving treatment efficacy and safety[205]. - The proprietary StableHu technology has been shown to reduce lead optimization times by utilizing over 1 billion human antibodies in preclinical studies[216]. - The AI Discovery Platform is central to iBio's strategic collaborations, facilitating the development of hard-to-drug molecules[228]. - iBio's technology stack addresses key challenges in antibody discovery, including limited drug targets and safety concerns for widely expressed targets[204]. Research and Development - The company is focused on advancing its preclinical pipeline in immune-oncology while assessing licensing options for additional therapeutic areas[208]. - The company entered into a research collaboration with NIAID to develop a vaccine for Lassa fever using its AI-driven epitope steering platform[231]. - The company is building its preclinical pipeline focused on hard-to-drug targets in obesity, cardiometabolic diseases, and immune-oncology, seeking strategic partners for faster advancement[233]. - The lead TROP-2 x CD3 bispecific antibody demonstrated a significant 36% reduction in tumor size in a humanized mouse model after just 14 days following a single dose[246]. - The anti-CCR8 antibody showed a 22% reduction in tumor size in a mouse model for colon cancer, indicating its potential effectiveness[258]. - The company has progressed IBIO-101 to the IND-enabling phase, with promising attributes for Chemistry, Manufacturing, and Controls (CMC) progression[242]. - The company designed ten engineered epitopes for Lassa fever, which showed binding to neutralizing antibodies and ranked highly for expression, aiding cost-effective vaccine production[231]. - The anti-EGFRvIII antibody demonstrated a 43% reduction in tumor growth in preclinical studies, targeting a variant specific to tumor cells[253]. - The company is utilizing its AI Discovery Platform to enhance its pipeline development and is actively seeking future collaboration opportunities[232]. - The initial manufacturing run of non-cGMP material for the lead molecule was completed in November 2024, with potential early readouts expected in early 2025[237]. - The company is exploring the potential of anti-myostatin antibodies for obesity and cardiometabolic diseases, aiming to optimize potency and specificity[235]. Financial Performance - As of September 30, 2024, the company reported cash, cash equivalents, and restricted cash of approximately $11.3 million, expected to support operations into the first quarter of fiscal year 2026[274]. - The company incurred a net loss from continuing operations of approximately ($3.9) million, or ($0.46) per share, for the three months ended September 30, 2024, compared to a net loss of approximately ($5.1) million, or ($4.24) per share, for the same period in 2023[279]. - Research and Development (R&D) expenses decreased to $1.3 million for the three months ended September 30, 2024, down from $1.6 million in the same period of 2023, reflecting a reduction of approximately ($0.3) million[276]. - General and Administrative (G&A) expenses were approximately $2.8 million for the three months ended September 30, 2024, compared to $3.5 million in the same period of 2023, a decrease of ($0.7) million[276]. - Total operating expenses for the three months ended September 30, 2024, were approximately $4.1 million, down from approximately $5.2 million in the same period of fiscal year 2023[277]. - The company has raised funds through equity offerings and other financing alternatives to mitigate substantial doubt about continuing as a going concern[272]. - The aggregate market value of shares of Common Stock eligible for sale under the At Market Issuance Sales Agreement is currently $7,350,000[265]. - The company plans to fund future operations through cash on hand, proceeds from commercialization, and potential asset sales or out-licensing[284]. - Net cash used in operating activities was approximately ($3.7) million for the three months ended September 30, 2024, compared to ($5.3) million for the same period in 2023[280]. - The company has an accumulated deficit of approximately ($317.8) million as of September 30, 2024, compared to approximately ($294.7) million as of September 30, 2023[282]. Asset Management and Valuation - The carrying amount of the IBIO101 therapeutic technology was $5 million as of June 30, 2024, with a fair value determined to be $5.9 million, indicating no impairment[290][291]. - The impairment testing for indefinite-lived intangible assets is performed annually, with the next evaluation scheduled for fiscal 2025[288][292]. - The probability of success for cash flows related to IBIO101 was adjusted and discounted at a rate of 16%, based on the company's weighted average cost of capital[291]. - No triggering events for impairment were identified in the first quarter of fiscal 2025, but the company will monitor stock price declines and FDA decisions on competing technologies[292]. - The company operates in a competitive environment with rising interest rates, which may necessitate adjustments to cash flow projections and valuation assumptions[293]. Compliance and Governance - Critical accounting estimates include revenue recognition, legal contingencies, research and development expenses, and share-based compensation expenses[294]. - Disclosure controls and procedures were deemed effective as of September 30, 2024[297]. - There were no changes in internal control over financial reporting during the quarter ended September 30, 2024[298]. - The company is not currently subject to any material legal proceedings, although it may face various claims in the ordinary course of business[299].

SAN DIEGO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSEA:IBIO) today reported financial results for the fiscal first quarter ended September 30, 2024 and provided a corporate update on its progress. “In our fiscal first quarter we advanced our collaboration with AstralBio, manufacturing and dosing a lead molecule with therapeutic potential for muscle wasting and obesity in non-human primate in vivo studies and progressing early work on additional targets. We strengthened our leadership team by hiring ...

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, 2024 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 ...

Financial Performance - Revenues for the fiscal year ended June 30, 2024, were approximately $0.225 million, a 100% increase compared to fiscal 2023[7] - iBio's consolidated net loss for the fiscal year ended June 30, 2024, was $24.9 million, a decrease of $40.1 million compared to 2023, primarily due to reduced expenses from discontinued operations and cost-saving initiatives[8] Expenses and Cost Management - Research and development expenses decreased by $5.1 million to $5.185 million, while general and administrative expenses decreased by $7.3 million to $11.674 million compared to fiscal 2023[8] - The company eliminated approximately $13.2 million in secured debt from its balance sheet by selling its manufacturing facility for $8.5 million and satisfying all obligations related to the debt[6] Financing Activities - iBio closed a public offering in the fiscal second quarter for gross proceeds of approximately $4.5 million and a private investment in public equity financing in the fiscal fourth quarter for gross proceeds of approximately $15.0 million[5] - The company strengthened its cash position by approximately $4.5 million from previously issued warrants during the third and fourth quarters[6] Cash and Assets - iBio's cash, cash equivalents, and restricted cash totaled $14.4 million as of June 30, 2024[8] - Cash and cash equivalents increased significantly from $4,301,000 in June 30, 2023 to $14,210,000 in June 30, 2024, marking an increase of over 230%[13] - Total current assets decreased from $26,259,000 in June 30, 2023 to $15,672,000 in June 30, 2024, representing a decline of approximately 40%[13] - The total assets decreased from $41,207,000 in June 30, 2023 to $28,734,000 in June 30, 2024, a decline of approximately 30%[13] Liabilities and Equity - Total liabilities decreased from $25,826,000 in June 30, 2023 to $7,410,000 in June 30, 2024, a reduction of approximately 71%[13] - Stockholders' equity increased from $15,381,000 in June 30, 2023 to $21,324,000 in June 30, 2024, reflecting an increase of about 38%[14] - The accumulated deficit widened from $(288,940,000) in June 30, 2023 to $(313,847,000) in June 30, 2024, indicating a decrease in retained earnings[14] - Additional paid-in capital rose from $304,320,000 in June 30, 2023 to $335,162,000 in June 30, 2024, an increase of approximately 10%[14] Shareholder Information - The number of common shares issued and outstanding increased from 1,015,505 to 8,623,676 between June 30, 2023 and June 30, 2024[14] Current Liabilities - Current liabilities related to assets held for sale decreased from $1,941,000 in June 30, 2023 to $0 in June 30, 2024[13] - The finance lease obligations - net of current portion decreased from $351,000 in June 30, 2023 to $53,000 in June 30, 2024, a reduction of about 85%[13] Clinical and Collaborative Developments - The company advanced a Trop2 x CD3 molecule to clinical candidate selection stage, demonstrating a significant 36% reduction in tumor size in a humanized mouse model[4] - iBio entered into a collaboration with AstralBio, Inc. to develop four targets in the cardiometabolic and obesity space, with rights to license up to three targets prior to clinical entry[4] Audit and Going Concern - The company received an audit opinion with a going concern paragraph, indicating substantial doubt about its ability to continue as a going concern[9]

SAN DIEGO, Sept. 20, 2024 (GLOBE NEWSWIRE) -- iBio, Inc. (NYSEA:IBIO), an AI-driven innovator of precision antibody immunotherapies, today announced its financial results for the fiscal year ended June 30, 2024, and provided a corporate update. "Our fiscal year 2024 was a transformational year for iBio, as we've solidified our business and financial position as a next-generation antibody company with a machine-learning-enabled platform for designing and developing difficult-to-drug therapeutics," said CEO a ...

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, 2024 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 juris ...