iBio(IBIO) - 2026 Q2 - Quarterly Report

Drug Development and Clinical Trials - iBio's AI Drug Discovery Platform enables the rapid generation of antibody therapeutics characterized by high specificity and optimized developability [265]. - The company anticipates IBIO-600 will enter Phase 1a clinical trials in the first half of calendar 2026, marking a significant milestone [242]. - In preclinical studies, IBIO-610 demonstrated an 8.9% reduction in body weight and a 26% reduction in fat mass in a diet-induced obesity mouse model [251]. - The combination of IBIO-610 with semaglutide resulted in a 35.3% weight loss, compared to 27.8% with semaglutide alone [252]. - IBIO-610 exhibited a terminal half-life of approximately 33.2 days in non-human primates, with projected human half-life estimated between 47 to 100 days [254]. - The company is developing a bispecific antibody targeting both myostatin and Activin A, showing promise in enhancing muscle cell differentiation [256]. - IBIO-600 was observed to prevent lean mass loss when administered in combination with a GLP-1 receptor agonist in preclinical studies [258]. - Early preclinical results from an amylin receptor antibody program showed a ~60% reduction in acute food intake in a proof-of-concept study [264]. Financial Performance - The company reported a net loss of approximately $14.7 million for the six months ended December 31, 2025, with negative cash flows from operations of approximately $10.9 million [299]. - The company reported a net loss of $9.0 million, or $0.09 per share, for the three months ended December 31, 2025, compared to a net loss of approximately $4.4 million, or $0.48 per share, for the same period in 2024 [306]. - For the six months ended December 31, 2025, the company reported a net loss of $14.7 million, or $0.19 per share, compared to a net loss of approximately $8.4 million, or $0.94 per share, for the same period in 2024 [312]. - The accumulated deficit as of December 31, 2025, was approximately $346.9 million, up from approximately $322.2 million as of December 31, 2024 [318]. Cash and Assets - Total current assets as of December 31, 2025, were approximately $53.4 million, including approximately $28.7 million in cash and cash equivalents [299]. - As of December 31, 2025, the company's cash and cash equivalents, along with investments in debt securities, totaled approximately $52.7 million, sufficient to fund operations for at least 12 months [300]. - The company raised approximately $26 million in gross proceeds from a private placement involving the issuance of 1,408,481 shares of common stock and pre-funded warrants [293]. - The purchase price per share in the private placement was $2.35, with pre-funded warrants priced at $2.349 [292]. - Net cash provided by financing activities during the six months ended December 31, 2025, was approximately $55.5 million, primarily from a public offering that raised approximately $50 million [315]. Research and Development Expenses - Research and Development (R&D) expenses increased to $4.3 million for the three months ended December 31, 2025, up from $1.9 million in the same period of 2024, reflecting a rise of approximately 126% [303]. - General and Administrative (G&A) expenses rose to approximately $5.2 million for the three months ended December 31, 2025, compared to $2.7 million in the same period of 2024, an increase of approximately 93% [304]. - Total operating expenses for the three months ended December 31, 2025, were approximately $9.4 million, compared to approximately $4.6 million in the same period of fiscal year 2024 [305]. - The operating capital deficit for the six months ended December 31, 2025, was $10.9 million, compared to a $7.6 million deficit for the same period in 2024 [299]. Strategic Collaborations - The company has entered into a collaboration with AstralBio to develop novel antibodies for obesity and cardiometabolic diseases, granting an exclusive license for four targets [287]. - iBio's strategic approach includes pursuing selective collaborations and out-licensing opportunities to broaden the use of its AI Drug Discovery Platform [247]. - The company is exploring partnerships for its preclinical immune-oncology candidates and seeking opportunities for future collaborations using its AI Drug Discovery Platform [291]. Technology and Innovation - The proprietary StableHu technology has been trained using over 1 billion human antibodies to optimize antibody development [274]. - The EngageTx CD3-based T-cell engager panel aims to reduce cytokine release while maintaining potent tumor-killing activity [279]. - The ShieldTx platform integrates antibody masking technology to enhance safety and efficacy by activating antibodies only in diseased tissues [282].