IBIO — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-12

• Our strategy is built on multiple key principles. First, we aim to develop next-generation antibody therapeutics addressing limitations of currently approved treatments, offering options with the potential to preserve muscle mass, target fat selectively, and provide durable weight loss with improved…

• Obesity is associated with a broad range of cardiometabolic and cardiopulmonary complications, therefore, we are also evaluating selected adjacent indications where our AI Drug Discovery Platform and target biology may offer differentiated therapeutic opportunities. Our current therapeutics are all …

• After receiving Clinical Trial Notification acknowledgement from Australia’s Therapeutic Goods Administration and ethics approval from a Human Research Ethics Committee, we anticipate IBIO-600 will enter Phase 1a clinical trials in Australia in the second quarter of calendar 2026, marking a pivotal …

• IBIO-610 was evaluated in a preclinical pharmacokinetic (“PK”) and body composition study in obese, mature non-human primates (“NHPs”) designed to characterize systemic exposure and assess early signs of activity on fat and body composition. In previously disclosed results from this study, IBIO-610 …

• We are developing a bispecific antibody program targeting myostatin, GDF11 and Activin A. We are evaluating this program for potential use in obesity and cardiopulmonary disease, including PH-HFpEF. Leveraging our innovative AI Drug Discovery Platform, this program is in late discovery, where multip…

Text removed vs the prior filing · source: 10-Q · 2026-02-10

• Our obesity strategy is built on three key principles. First, we aim to develop next-generation antibody therapeutics addressing limitations of currently approved treatments, offering options with a goal to preserve muscle mass, target fat selectively, and provide durable weight loss with improved t…

• IBIO-610 was evaluated in a pharmacokinetic (“PK”) preclinical study in obese, mature non-human primates (“NHPs”) to characterize systemic exposure and clearance following a single intravenous administration. Serum concentrations were measured at defined intervals post-dose to generate a time-concen…

• We initiated a program to develop a bispecific antibody targeting both myostatin and Activin A. Leveraging our StableHu™ platform and mammalian display, this program is in late discovery, where multiple parameters, such as binding affinity, expression levels, and stability, are being optimized. Earl…

• Following the NHP pharmacokinetic study, we initiated CMC and nonclinical toxicology activities to support the advancement of IBIO-600 toward clinical development. We have completed manufacturing and fill/finish of a GMP batch of IBIO-600, with long term stability testing ongoing. To continue develo…

• combinations that would otherwise be too toxic, and open the door to pursuing targets whose expression across multiple tissues would normally raise safety concerns.

Text added vs the prior filing · source: 10-Q · 2026-05-12

• Our future profitability and cash flow in large part depends on our research and development programs, including our AI platform, and our ability to successfully develop, partner or commercialize our product candidates and to a lesser extent, which is not anticipated for several years. Our cash posi…

• alone or with our licensees and collaborators, to be successful in a range of challenging activities, including completing preclinical testing and clinical trials of our product candidates, obtaining regulatory approval for these product candidates and manufacturing, marketing and selling those prod…

• Our stockholders will experience substantial dilution from the issuance of shares of Common Stock upon the exercise of outstanding warrants issued in our public and private offerings. Raising additional capital may also cause dilution to our existing stockholders, restrict our operations or require …

• As of March 31, 2026, up to 89,042,863 shares of Common Stock are issuable upon the exercise of pre-funded warrants, with an exercise price of $0.001, and up to 38,555,185 shares of Common Stock are issuable upon the exercise of outstanding warrants, the issuance of which will result in substantial …

• Until such time as we can generate substantial development, manufacturing, license or product revenues, we expect to finance our cash needs through a combination of equity offerings, collaborations, strategic alliances, service contracts, manufacturing contracts, licensing and other arrangements. So…

Text removed vs the prior filing · source: 10-Q · 2026-02-10

• Our future profitability and cash flow in large part depends on our research and development programs, including our AI platform, and our ability to successfully develop, partner or commercialize our product candidates and to a lesser extent, which is not anticipated for several years. Our cash posi…

• A recurring shutdown of the U.S. federal government may adversely affect our business operations and regulatory compliance. During such shutdowns, while the SEC’s EDGAR system remains operational, the unavailability of SEC staff to review filings, issue comments, or declare registration statements e…