iBio (NYSEAM:IBIO) FY Conference December 04, 2025 08:45 AM ET Company ParticipantsMartin Brenner - CEO and Chief Scientific OfficerFelipe Duran - CFOModeratorOkay, let's get started. Good morning, everybody. Welcome to the third day of the iBio Conference in Miami, Healthcare Conference. With us today is the management team of iBio. Happy to host Martin Brenner, CEO and CSO of the firm. And also with us is Felipe Duran, CFO. Gentlemen, welcome. Thank you so much for taking time out of your busy schedules t ...

Core Insights - iBio, Inc. will participate in the 8th Annual Evercore Healthcare Conference from December 2-4, 2025, in Miami, highlighting its focus on advancing its next-generation obesity pipeline [1][2]. Company Overview - iBio is an AI-driven biotech company specializing in precision antibody therapies for cardiometabolic diseases, obesity, cancer, and other challenging conditions [4]. - The company utilizes proprietary 3D modeling and innovative drug discovery platforms to develop breakthrough antibody treatments aimed at significant unmet medical needs [4]. Key Events - Martin Brenner, CEO and Chief Scientific Officer of iBio, will engage in a fireside chat on December 4, 2025, discussing the promising non-human primate data for IBIO-610, a potential first-in-class Activin E antibody [2]. - Felipe Duran, CFO of iBio, will be available for one-on-one meetings during the conference, providing opportunities for direct engagement with investors [3]. Additional Information - A livestream of the conference will be available, and a replay will be posted on the Investor section of the iBio website [3].

Core Insights - iBio, Inc. reported a quarterly loss of $0.11 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.07, marking an earnings surprise of -57.14% [1] - The company generated revenues of $0.1 million for the quarter ended September 2025, consistent with the Zacks Consensus Estimate, compared to zero revenues a year ago [2] - iBio shares have declined approximately 49.4% year-to-date, contrasting with the S&P 500's gain of 16.4% [3] Company Performance - Over the last four quarters, iBio has exceeded consensus EPS estimates only once [2] - The current consensus EPS estimate for the upcoming quarter is -$0.05 on revenues of $0.1 million, and for the current fiscal year, it is -$0.40 on revenues of $0.5 million [7] - The estimate revisions trend for iBio was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Industry Context - The Medical - Biomedical and Genetics industry, to which iBio belongs, is currently ranked in the top 34% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Product Development - iBio's preclinical product candidate pipeline includes IBIO-610, which demonstrated an 8.9% reduction in body weight and a 26% reduction in fat mass in a diet-induced obesity mouse model [236]. - The combination therapy of IBIO-610 with semaglutide resulted in a 35.3% weight loss, compared to a 27.8% reduction with semaglutide alone [237]. - IBIO-610 exhibited a terminal half-life of approximately 33.2 days in non-human primates, with a projected human half-life estimated between 47 to 100 days [239]. - The bispecific antibody targeting myostatin and Activin A is in late discovery, optimizing parameters such as binding affinity and stability [241]. - IBIO-600, a long-acting anti-myostatin antibody, showed a half-life of approximately 40 to 52 days in non-human primates, with a projected human half-life of 57 to 147 days [245]. - Early preclinical results for an amylin receptor antibody showed a ~60% reduction in acute food intake in a proof-of-concept study [249]. - iBio's AI Drug Discovery Platform enables rapid generation of antibody therapeutics characterized by high specificity and optimized developability [250]. - The platform integrates epitope engineering, a proprietary antibody library, and antibody optimization technologies to enhance the probability of success in drug development [251]. - The company has a pipeline of pre-clinical programs, including IBIO-600 and IBIO-610, focusing on obesity and cardiometabolic diseases, with ongoing efforts to seek partnerships for these programs [270]. Financial Performance - For the three months ended September 30, 2025, the company incurred a net loss of approximately $5.7 million, or $0.11 per share, compared to a net loss of approximately $4.0 million, or $0.46 per share for the same period in 2024 [287]. - Research and Development (R&D) expenses increased to $3.6 million for the three months ended September 30, 2025, up from $1.3 million in the same period of 2024, reflecting a rise of approximately 176% [284]. - General and Administrative (G&A) expenses decreased to approximately $2.5 million for the three months ended September 30, 2025, down from $2.8 million in the same period of 2024, a reduction of approximately 11% [285]. - Total operating expenses for the three months ended September 30, 2025, were approximately $6.1 million, compared to approximately $4.1 million in the same period of 2024, indicating an increase of approximately 49% [286]. - The company recognized revenue of $0.1 million for services provided to a collaborative partner during the three months ended September 30, 2025, while no revenue was recognized in the same period of 2024 [283]. Cash Position and Liquidity - As of September 30, 2025, the company had total current assets of approximately $50.8 million, including approximately $28.1 million in cash and cash equivalents [278]. - The company raised gross proceeds of approximately $50 million from an underwritten public offering in August 2025, with net proceeds of approximately $46.5 million after deducting underwriting discounts and commissions [276]. - The company’s current cash position is believed to be sufficient to fund operations for at least 12 months from the date of filing the Quarterly Report [279]. - The company’s liquidity position is challenged by a history of significant losses and negative cash flows from operations, raising substantial doubt about its ability to continue as a going concern [280]. - Net cash used in operating activities was approximately $5.7 million for the three months ended September 30, 2025, compared to $3.7 million for the same period in 2024, primarily due to funding net losses [288]. - Net cash used in investing activities was approximately $21.5 million for the three months ended September 30, 2025, attributed to the purchase of debt securities and fixed assets, while it was $0.7 million for the same period in 2024 [289]. - Net cash provided by financing activities was approximately $46.7 million for the three months ended September 30, 2025, from the sale of securities, offset by debt payments, compared to $0.2 million used in financing activities in 2024 [290]. - As of September 30, 2025, the accumulated deficit was approximately $337.9 million, increasing from $317.8 million as of September 30, 2024 [292]. - Current cash, cash equivalents, and investments in debt securities were approximately $49.6 million as of September 30, 2025, expected to support operations into the fourth quarter of fiscal year 2027 [292]. Future Outlook and Risks - The company plans to fund future operations through cash on hand, commercialization proceeds, and potential asset sales or collaborations, but there is no assurance of success [293]. - The company may need to adjust cash flow projections and valuation assumptions due to competitive pressures and rising interest rates, which could lead to future impairments [304]. - No triggering events for impairment were identified during the three months ended September 30, 2025, but the company will continue to monitor the value of its intangible assets [303]. - The company does not participate in off-balance sheet arrangements or transactions with unconsolidated entities as of September 30, 2025 [294]. - The company anticipates commencing its first human clinical trials for IBIO-610 in early 2027 [228].

Revenue - Revenue for the three months ended September 30, 2025, was $0.1 million, compared to no revenue for the same period in 2024[8] Expenses - Research and Development expenses increased to $3.6 million for the three months ended September 30, 2025, from $1.3 million in 2024, representing an increase of approximately 176.9%[8] - General and Administrative expenses decreased to approximately $2.5 million for the three months ended September 30, 2025, from $2.8 million in 2024, a decrease of about 10.7%[8] - Total operating expenses for the three months ended September 30, 2025, were $6.05 million, compared to $4.11 million in 2024, an increase of approximately 47.2%[11] Financial Position - iBio held cash, cash equivalents, and investments in debt securities of $49.6 million as of September 30, 2025, sufficient to support operations into the fourth quarter of fiscal year 2027[8] - iBio's total assets increased to $64.16 million as of September 30, 2025, from $23.19 million as of June 30, 2025[13] Net Loss - iBio reported a net loss of $5.72 million for the three months ended September 30, 2025, compared to a net loss of $3.99 million for the same period in 2024[11] Capital Raising - iBio closed a $50 million underwritten public offering with the potential for an additional $50 million in gross proceeds upon full exercise of the common warrants, totaling up to $100 million before deducting underwriting discounts and commissions[3] Compliance - iBio regained compliance with Nasdaq Listing Rule 5550(a)(2) on November 4, 2025[3] Product Development - The predicted human half-life of IBIO-610 is up to 100 days, allowing for dosing as infrequent as twice per year[3]

Core Insights - iBio, Inc. has strengthened its cash position and extended its operational runway into the fourth quarter of fiscal year 2027 after closing a public offering with potential gross proceeds of up to $100 million [1][7] - The company presented promising non-human primate data for its Activin E antibody, IBIO-610, which may allow for only twice-yearly dosing for obesity treatment, indicating a significant advancement in patient compliance and therapeutic potential [2][7] Financial Results - For the fiscal quarter ended September 30, 2025, iBio reported revenue of $0.1 million, compared to no revenue for the same period in 2024 [7][10] - Research and Development (R&D) expenses increased to $3.6 million from $1.3 million year-over-year, attributed to advancing preclinical research activities [7][10] - General and Administrative expenses decreased to approximately $2.5 million from $2.8 million, mainly due to reduced professional expenses and legal fees [7][10] - The net loss for the quarter was $5.7 million, compared to a net loss of $4.0 million in the prior year [10] Corporate Updates - iBio regained compliance with Nasdaq Listing Rule 5550(a)(2) on November 4, 2025 [7] - The company held cash, cash equivalents, and investments totaling $49.6 million as of September 30, 2025, which is expected to support operations into the fourth quarter of fiscal year 2027 [7][11] Product Development - The non-human primate data for IBIO-610 indicates a predicted human half-life of up to 100 days, supporting infrequent dosing and reinforcing its potential as a next-generation therapy for obesity and cardiometabolic diseases [2][7] - The findings from the studies presented at ObesityWeek® 2025 and PEGS Europe highlight IBIO-610's differentiated mechanism, enabling fat-selective weight loss and sustained weight maintenance after GLP-1 therapy discontinuation [7] Company Overview - iBio, Inc. is a biotech company focused on developing next-generation biopharmaceuticals for cardiometabolic diseases, obesity, cancer, and other challenging conditions using AI and advanced computational biology [5]

Summary of iBio (NYSEAM:IBIO) FY Conference Call - November 10, 2025 Company Overview - iBio was founded in 2008-2009 as a consortium aimed at developing plant-based vaccines for the U.S. Army [2][2] - The company pivoted to a Contract Development and Manufacturing Organization (CDMO) in 2015 and raised capital to develop a COVID vaccine [2][2] - In 2022, iBio acquired Rubrik Therapeutics, enhancing its platform for discovering hard-to-drug antibodies [2][2] Key Developments and Collaborations - iBio established a research agreement with Eli Lilly, achieving significant progress on a hard-to-drug molecule in eight months [3][3] - The company sold a PD-1 agonist to Otsuka for $1 million upfront and potential commercial milestones of $52.5 million [3][3] - A collaboration with AstroBio focused on four obesity targets, leading to the in-licensing of three targets: myostatin, Activin E, and Amlin [4][4] Obesity Treatment Strategy - iBio is targeting unmet medical needs in obesity treatment, recognizing the competitive landscape dominated by GLP-1 receptor agonists [5][5] - The company is developing a portfolio of programs to address obesity from multiple angles, including food intake reduction and muscle-sparing agents [6][6] - The strategy includes developing drugs that can be used in combination with GLP-1 treatments to enhance efficacy and reduce dropout rates [6][6] Pipeline and Development Stages - The highest priority molecule is an Activin E antibody, currently in IND enabling stages, with promising pharmacokinetic data suggesting a twice-a-year dosing regimen [8][9] - iBio's myostatin program is progressing through toxicology studies, with plans to file in Australia in the second quarter of next year [19][19] - The Amlin program is in rodent studies, with plans for non-human primate studies to follow [26][26] Market Position and Future Outlook - iBio aims to differentiate itself in the obesity market by addressing the complexity of the disease and the need for combination therapies [27][27] - The company anticipates a shift in the market towards maintenance therapies that can be dosed infrequently, targeting a twice-a-year regimen [28][28] Financial Position and Funding - iBio raised $50 million in August, with potential for an additional $50 million through a unique financing structure tied to IND acceptance [31][31] - The current cash position is expected to sustain operations through the first quarter of 2027 [31][31] Upcoming Catalysts - Non-human primate data for Activin E is expected in the first half of next year, with IND filing planned for the end of 2026 [33][33] - The myostatin program is on track for IND filing in the first half of next year, with first patient dosing anticipated shortly thereafter [33][33] - The Amlin program is also progressing towards non-human primate studies, with timelines aligned for future development [33][33]

Core Insights - iBio, Inc. has announced promising preclinical data for IBIO-610, a potential first-in-class Activin E antibody, which shows an extended half-life in obese non-human primates and a predicted human half-life of up to 100 days, allowing for dosing as infrequently as twice a year [1][2][4] Group 1: Product Development - IBIO-610 demonstrates a half-life of 33.2 days in non-human primates, with projections indicating a human half-life of up to 100 days, which could significantly enhance patient experience by reducing dosing frequency to once every six months [1][2] - The antibody's mechanism of action is expected to provide a more comprehensive pathway modulation for obesity treatment compared to existing therapies [4] Group 2: Market Positioning - The CEO of iBio highlighted the need for durable treatment options beyond appetite control, emphasizing the potential of IBIO-610 to fill this gap in patient care [2] - The company’s AI-enabled discovery platform has successfully developed a long-acting antibody against Activin E, which could leverage the scalability of global antibody manufacturing [2] Group 3: Upcoming Presentation - The findings regarding IBIO-610 will be presented at ObesityWeek 2025, scheduled for November 4-7 in Atlanta, which may enhance visibility and interest in the product [1][2]

Core Insights - iBio, Inc. will participate in the Guggenheim 2nd Annual Healthcare Innovation Conference from November 10–12, 2025, in Boston [1] - CEO Martin Brenner will discuss the company's transition to a clinical-stage biotechnology firm and its advancements in the obesity pipeline during a fireside chat on November 10, 2025 [2] - iBio is focused on developing next-generation biopharmaceuticals for various diseases, including obesity, using AI and advanced computational biology [4] Company Developments - The company aims to create a pipeline of innovative antibody treatments to address significant unmet medical needs in cardiometabolic diseases and obesity [4] - iBio's differentiated antibody programs are designed to complement existing obesity therapies and generate long-term value through innovation [2] - CFO Felipe Duran will be available for one-on-one meetings during the conference, indicating a proactive approach to investor engagement [3] Event Participation - The conference will feature a livestream of the event, with a replay available on the investor section of iBio's website [3] - The participation in this conference highlights iBio's commitment to showcasing its advancements and engaging with the investment community [1][2]

Core Insights - iBio Inc. (NASDAQ:IBIO) has seen a significant increase in stock price, trading up 11.51% to $1.55 in pre-market sessions, following a 25.23% rise to $1.39 in the previous day's regular session [1][2] Company Announcements - iBio announced that its executives will present data on its obesity treatment candidate, IBIO-610, at two industry conferences in November [2] - Dr. Cory Schwartz will present on November 4 in Atlanta, focusing on a first-in-class Activin E antagonist antibody for obesity treatment, including data from nonhuman primate studies [3] - CEO Martin Brenner will present on November 12 in Lisbon, discussing the fat-selective weight loss effects of the anti-Activin E antibody in diet-induced obese mice [3] Stock Performance - Year-to-date, iBio's stock is down 43.27%, but it has gained 82.89% over the past six months [4] - The stock has a 52-week range of $0.56 to $6.89, with a market capitalization of $28.15 million and an average daily trading volume of 2.64 million shares [4] - Current analysis indicates that IBIO is experiencing long-term consolidation in its stock performance [4]