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iBio Presents Next-Generation Obesity and Cardiometabolic Pipeline Candidates on June 24 Conference Call
Globenewswire· 2025-06-23 20:15
Core Insights - iBio, Inc. is set to announce a third target in its collaboration with AstralBio, focusing on advancements in obesity and cardiometabolic disease treatments [1][2] - The company aims to pioneer next-generation antibody medicines that are targeted, longer-lasting, and potentially better tolerated, with a strategic overview of its obesity treatment strategy [2][4] Company Overview - iBio is a biotech company utilizing AI and advanced computational biology to develop biopharmaceuticals for various diseases, including cardiometabolic diseases, obesity, and cancer [4] - The company combines proprietary 3D modeling with innovative drug discovery platforms to create a pipeline of breakthrough antibody treatments addressing significant unmet medical needs [4] Upcoming Events - A conference call is scheduled for June 24, 2025, at 8:30 a.m. ET to discuss the latest advancements and the new target in the AstralBio collaboration [1][3]
iBio Initiates Non-Human Primate Study of First-in-Class Activin E Antibody Following Positive Preclinical Data Demonstrating Prevention in Weight Regain After GLP-1 Treatment
GlobeNewswire News Room· 2025-06-16 11:00
iBio nominates IBIO-610 as development candidate for its first-in-class Activin E antibody New study aims to evaluate the half-life of IBIO-610 in obese, elderly non-human primates (NHP) and assess early signs of efficacy on fat reduction and body composition Mouse study shows IBIO-610 alone drives an overall body weight loss of 8.9%*, and prevents weight regain following GLP-1 treatment in obese mice, results of which will be presented at ADA on Monday June 23rd SAN DIEGO, June 16, 2025 (GLOBE NEWSWIRE) -- ...
iBio's First-in-Class Activin E Antibody Achieves >26% Fat Reduction Without Muscle Loss and Shows Synergy with GLP-1s in Preclinical Model
GlobeNewswire News Room· 2025-05-05 12:00
Core Insights - iBio, Inc. announced promising preclinical data for its Activin E antibody, showing a 26% reduction in fat mass in diet-induced obese mice while preserving muscle mass [1][6] - The study demonstrated significant reductions in specific fat depots, with a 31% reduction in subcutaneous fat and reductions of 34% and 37% in epididymal and retroperitoneal fat, respectively [3][6] - When combined with a GLP-1 receptor agonist, the Activin E antibody resulted in a total fat mass reduction of 77%, indicating strong synergistic effects [3][6] Company Overview - iBio, Inc. is a biotech company focused on developing biopharmaceuticals for cardiometabolic diseases, obesity, and cancer using AI and advanced computational biology [4] - The company aims to transform drug discovery and accelerate development timelines through innovative drug discovery platforms and proprietary 3D modeling [4]
iBio’s First-in-Class Activin E Antibody Achieves >26% Fat Reduction Without Muscle Loss and Shows Synergy with GLP-1s in Preclinical Model
Globenewswire· 2025-05-05 12:00
Core Insights - iBio, Inc. has announced promising preclinical data for its Activin E antibody, showing a 26% reduction in fat mass in diet-induced obese mice while preserving muscle mass [1][6] - The study indicates that fat-specific weight loss is a higher-quality form of weight loss, reducing risks associated with heart and metabolic diseases [2][3] - The Activin E antibody demonstrated significant reductions in specific fat depots, with a 31% reduction in subcutaneous fat and reductions of 34% and 37% in epididymal and retroperitoneal fat, respectively [3][6] - When combined with a GLP-1 receptor agonist, the Activin E antibody resulted in a total fat mass reduction of 77%, with subcutaneous fat loss increasing to 74% [3][6] Company Overview - iBio, Inc. is a biotech company focused on developing next-generation biopharmaceuticals for cardiometabolic diseases, obesity, and cancer using AI and advanced computational biology [4] - The company aims to transform drug discovery and accelerate development timelines to address significant unmet medical needs in precision medicine [4]
iBio(IBIO) - 2025 Q3 - Quarterly Report
2025-05-02 12:29
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) iBio, Inc.'s March 31, 2025, financial statements reflect significant losses, negative cash flows, and a 'Going Concern' warning [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to **$19.1 million** by March 31, 2025, from **$28.7 million** at June 30, 2024, reflecting reduced cash and equity Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (Unaudited) | June 30, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $4,959 | $14,210 | | Total Current Assets | $6,060 | $15,672 | | Total Assets | $19,103 | $28,734 | | **Liabilities & Equity** | | | | Total Current Liabilities | $5,397 | $3,840 | | Total Liabilities | $7,722 | $7,410 | | Total Stockholders' Equity | $11,381 | $21,324 | [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Net loss from continuing operations increased to **$4.9 million** for Q3 2025 and **$13.2 million** for the nine months, driven by higher R&D Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2025 | Q3 2024 | Nine Months 2025 | Nine Months 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenue | $0 | $0 | $200 | $50 | | Research and development | $1,906 | $904 | $5,088 | $4,045 | | General and administrative | $2,973 | $2,722 | $8,516 | $9,230 | | Operating loss | $(4,879) | $(3,626) | $(13,404) | $(13,225) | | Net loss from continuing operations | $(4,861) | $(2,635) | $(13,214) | $(12,197) | | Loss per share (continuing ops) | $(0.49) | $(0.71) | $(1.44) | $(5.43) | [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Stockholders' equity decreased from **$21.3 million** to **$11.4 million** due to a **$13.2 million** net loss, partially offset by capital raises - The accumulated deficit increased from **$(313.8) million** to **$(327.1) million** during the nine months ended March 31, 2025, due to ongoing net losses[13](index=13&type=chunk) - The company issued common stock and received proceeds from stock option exercises, which increased additional paid-in capital from **$335.2 million** to **$338.4 million** over the nine-month period[13](index=13&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$10.7 million** for the nine months ended March 31, 2025, resulting in a **$9.2 million** overall decrease in cash Cash Flow Summary (Nine Months Ended March 31, in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,689) | $(13,700) | | Net cash provided by investing activities | $697 | $1,050 | | Net cash provided by financing activities | $749 | $11,502 | | **Net decrease in cash** | **$(9,243)** | **$(1,148)** | [Notes to the Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's AI-enabled biotech transformation, 'Going Concern' warning, and significant financing activities - The company is a preclinical biotechnology company using AI and Machine Learning for developing antibodies, focusing on obesity, cardiometabolic diseases, and immune-oncology[24](index=24&type=chunk)[31](index=31&type=chunk) - Management has concluded there is substantial doubt about the Company's ability to continue as a going concern due to a history of significant losses, negative cash flows, and limited cash resources[41](index=41&type=chunk) - On December 31, 2024, the company entered an exclusive license agreement with AstralBio for a myostatin antibody (IBIO-600), paying the **$750,000** upfront fee by issuing **246,087** shares of common stock[106](index=106&type=chunk)[107](index=107&type=chunk) - Subsequent to the quarter end, on April 29, 2025, the company raised approximately **$6.2 million** in gross proceeds through a warrant inducement agreement, exercising **5.6 million** existing warrants at a reduced price and issuing new warrants[254](index=254&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=62&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) MD&A discusses the company's strategic shift to AI-driven antibody discovery, reiterates 'going concern' doubt, and details capital-raising efforts and operating expenses - The company's strategy is to leverage its AI platform for in-house programs, strategic collaborations, and technology licensing to create value[263](index=263&type=chunk)[266](index=266&type=chunk) - The company's pipeline is focused on two main areas: Obesity/Cardiometabolic Diseases (IBIO-600, Activin A, Activin E) and Immuno-Oncology (IBIO-101, TROP-2xCD3, MUC16xCD3, etc.)[290](index=290&type=chunk)[304](index=304&type=chunk) - A 'Going Concern' issue is highlighted, with cash as of May 1, 2025 (approx. **$10.5 million**) sufficient only through the end of Q1 fiscal 2026 without further capital[331](index=331&type=chunk)[338](index=338&type=chunk) Comparison of Operating Expenses (Three Months Ended March 31) | Expense (in millions) | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research & Development | $1.9 | $0.9 | +$1.0 | | General & Administrative | $3.0 | $2.7 | +$0.3 | Comparison of Operating Expenses (Nine Months Ended March 31) | Expense (in millions) | 2025 | 2024 | Change | | :--- | :--- | :--- | :--- | | Research & Development | $5.1 | $4.0 | +$1.1 | | General & Administrative | $8.5 | $9.2 | -$0.7 | [Quantitative and Qualitative Disclosures About Market Risk](index=84&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, iBio, Inc. is not required to provide market risk disclosures - The company is a smaller reporting company and is not required to provide the information required by Item 3[368](index=368&type=chunk) [Controls and Procedures](index=84&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[370](index=370&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[371](index=371&type=chunk) [PART II. OTHER INFORMATION](index=84&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=84&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings, though ordinary course claims may arise - iBio is not currently subject to any material legal proceedings[372](index=372&type=chunk) [Risk Factors](index=85&type=section&id=Item%201A.Risk%20Factors) Significant risks include 'going concern' doubt, dependence on capital raises, potential stockholder dilution, and Nasdaq delisting risk - There is substantial doubt about the company's ability to operate as a going concern beyond the first quarter of fiscal year 2026 without raising additional capital[378](index=378&type=chunk)[379](index=379&type=chunk) - The company has a history of significant losses, with an accumulated deficit of **$327.1 million** as of March 31, 2025, and expects to incur further losses[383](index=383&type=chunk) - Future capital raises and the exercise of outstanding warrants will cause substantial dilution to existing stockholders[390](index=390&type=chunk) - Failure to comply with Nasdaq's continued listing standards could result in the delisting of the company's common stock[393](index=393&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=90&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q3 FY2025, the company issued unregistered securities, including stock options to a vendor and shares to AstralBio as part of a license agreement - Issued an option to a professional service vendor to purchase **20,000** shares of Common Stock at an exercise price of **$1.83** per share[395](index=395&type=chunk) - Issued **246,087** shares of Common Stock to AstralBio on January 28, 2025, pursuant to the Myostatin License Agreement[396](index=396&type=chunk) [Defaults Upon Senior Securities](index=90&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section is not applicable to the company [Mine Safety Disclosures](index=90&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company [Other Information](index=90&type=section&id=Item%205.%20Other%20Information) This section details a significant post-period financing event on April 29, 2025, involving a warrant inducement agreement that generated **$6.2 million** in gross proceeds - On April 29, 2025, the company entered into an Inducement Agreement to encourage the exercise of existing warrants[401](index=401&type=chunk) - The agreement resulted in the cash exercise of warrants for **5,626,685** shares at a reduced price of **$0.86** per share, generating gross proceeds of approximately **$6.2 million**[401](index=401&type=chunk) - In consideration, the company issued new 'Inducement Warrants' to purchase up to **11,253,370** shares at an exercise price of **$0.86** per share[401](index=401&type=chunk)[402](index=402&type=chunk) [Exhibits](index=93&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the quarterly report, including corporate governance documents, material agreements, and CEO/CFO certifications
iBio(IBIO) - 2025 Q3 - Quarterly Results
2025-05-02 12:05
[Form 8-K Current Report](index=1&type=section&id=Form%208-K%20Current%20Report) This report outlines iBio, Inc.'s Form 8-K filing, covering registrant details, financial results, and associated exhibits [Registrant Information](index=1&type=section&id=Registrant%20Information) This section provides iBio, Inc.'s basic registrant information, including trading symbol, exchange, and report date - The report was filed by iBio, Inc. on May 2, 2025[2](index=2&type=chunk) Registrant Details | Category | Detail | | :--- | :--- | | **Registrant Name** | iBio, Inc. | | **State of Incorporation** | Delaware | | **Commission File Number** | 001-35023 | | **Principal Executive Office** | 11750 Sorrento Valley Road, Suite 200, San Diego, California 92121 | | **Trading Symbol** | IBIO | | **Exchange** | The Nasdaq Stock Market LLC | [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) iBio, Inc. announced Q1 2025 financial results via a furnished press release, limiting legal liabilities - The company announced its financial results for the quarter ended March 31, 2025, through a press release issued on May 2, 2025[5](index=5&type=chunk) - The information in the press release (Exhibit 99.1) is considered "furnished" and not "filed," meaning it is not subject to the liabilities of Section 18 of the Securities Exchange Act of 1934 and is not incorporated by reference into other SEC filings[6](index=6&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists Form 8-K exhibits, primarily the press release detailing the company's financial results Exhibits Furnished | Exhibit Number | Exhibit Description | | :--- | :--- | | 99.1 | Press Release, issued by iBio, Inc. dated May 2, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
iBio Reports Fiscal Third Quarter 2025 Financial Results
Globenewswire· 2025-05-02 12:00
Core Viewpoint - iBio, Inc. reported significant progress in its financial position and pipeline development during the third quarter of fiscal 2025, including a successful equity raise and promising data for its lead therapeutic candidates [2][4]. Financial Results - For the third quarter ended March 31, 2025, iBio reported R&D expenses of approximately $1.9 million, an increase of about $1.0 million compared to $0.9 million in the same period of 2024, primarily due to higher spending on consultants, supplies, and personnel [7]. - General and administrative (G&A) expenses for the same period were approximately $3.0 million, up from $2.7 million in 2024, with the increase attributed to IT costs, consulting fees, and franchise taxes [7]. - The net loss from continuing operations for the third quarter was approximately $4.9 million, or $0.49 per share, compared to a net loss of approximately $2.6 million, or $0.71 per share, in the same period of fiscal 2024 [7]. - As of March 31, 2025, cash, cash equivalents, and restricted cash totaled approximately $5.2 million, which increased to approximately $10.5 million following a warrant inducement transaction in April 2025 [7]. Corporate Updates - iBio successfully transitioned to trading on the Nasdaq Stock Exchange under the ticker symbol "IBIO," enhancing visibility and liquidity, and aligning with its strategy to attract long-term institutional investors [7]. - The company reported promising non-human primate data for IBIO-600, a long-acting anti-myostatin antibody, indicating extended half-life and dose-dependent muscle growth [7]. - iBio in-licensed a first-in-class Activin E antibody from AstralBio, expanding its pipeline focused on cardiometabolic diseases and obesity [7]. - The company raised $6.2 million in gross proceeds through a warrant inducement transaction, strengthening its balance sheet and providing additional working capital for pipeline advancements [7].
iBio Raises $6.2 Million Through Warrant Inducement Transaction
Globenewswire· 2025-04-29 17:43
Core Points - iBio, Inc. has entered into an agreement with existing institutional investors to exercise warrants for 5,626,685 shares at a reduced price of $1.11 per share, generating approximately $6.2 million in gross proceeds [1][2] - In exchange for exercising the existing warrants, investors will receive new warrants to purchase up to 11,253,370 shares at an exercise price of $0.86, expiring in five years [2] - The transaction is expected to close around April 30, 2025, pending customary closing conditions [2][3] Financial Details - The gross proceeds from the warrant exercise will be approximately $6.2 million before deducting advisory fees and other expenses [1] - The new warrants allow for the purchase of shares at a significantly lower price compared to the existing warrants [2] Company Overview - iBio, Inc. is a biotech company focused on developing precision antibody therapies using AI and advanced computational biology for various diseases [6] - The company aims to transform drug discovery and accelerate development timelines to address unmet medical needs [6]
iBio Expands Cardiometabolic and Obesity Pipeline through Licensing of First-in-Class Antibody Targeting Activin E from AstralBio
Newsfilter· 2025-04-22 12:00
SAN DIEGO, April 22, 2025 (GLOBE NEWSWIRE) -- Bio, Inc. (NASDAQ:IBIO), an AI-driven innovator of precision antibody therapies, today announced a licensing agreement with AstralBio Inc. for a preclinical first- in-class antibody targeting Activin E, which was discovered using iBio's patented Machine-Learning Antibody Engine. Activin E is a promising novel therapeutic target whose inhibition is believed to induce fat-selective weight loss and offer protection against obesity and cardiometabolic disease. iBio ...
iBio Announces IBIO-600 Non-Human Primate Data Showing Extended Half-Life and Muscle Growth, and Interim In Vivo Results for First-in-Class Activin E Antibody, Advancing Cardiometabolic and Obesity Pipeline
Newsfilter· 2025-04-07 11:00
Core Insights - iBio, Inc. has announced promising pharmacokinetics data for IBIO-600, a long-acting anti-myostatin antibody, suggesting a potential human half-life of up to 130 days, which could position it as a best-in-class treatment for muscle preservation and weight loss [1][4][5] - The company is on track to submit a regulatory application for IBIO-600 in Q1 2026, highlighting its commitment to innovation in obesity treatment [1][5] Group 1: IBIO-600 Development - The pharmacokinetics study involved non-human primates (NHPs) and indicated a half-life of 40 to 52 days in NHPs, with human estimates ranging from 57 to 130 days [4] - The study demonstrated a dose-dependent increase in lean mass and a reduction in fat mass, with the low-dose group showing a 3.1% increase in lean mass and the high-dose group a 5.1% increase after 8 weeks [3] - The potential for a dosing schedule of once every 3 to 6 months could significantly reduce the treatment burden for patients [4][5] Group 2: Activin E Antibody - iBio has also disclosed preclinical data for a first-in-class Activin E antibody, which effectively blocks Activin E signaling and shows promise as a novel obesity treatment [5] - In an exploratory study with obese mice, the Activin E antibody as a monotherapy resulted in a 4% fat-selective weight loss and an 18% reduction in total body fat compared to placebo [5] - When combined with semaglutide, the Activin E antibody enhanced total weight loss by an additional 9%, leading to an overall weight reduction of 34% and a 72% reduction in body fat [5]