iBio, Inc.

iBio, Inc.

Overview

iBio is a clinical-stage biotechnology company using AI and machine learning to design and develop precision antibodies for obesity and related cardiometabolic and cardiopulmonary complications. The company focuses on next-generation antibody therapeutics intended to enable fat-selective weight loss, preserve muscle mass, and improve tolerability through AI-driven antibody design, advanced screening, and developability optimization.

Pipeline and programs

• IBIO-600 (anti-myostatin, GDF8)
  • Long-acting antibody in Phase 1 clinical development.
  • First participant dosed in June 2026 in Australia; 31 participants dosed across four single-ascending-dose (SAD) cohorts as of the report.
  • Planned progression to a multiple-ascending-dose (MAD) portion following SAD completion.
• IBIO-610 (Activin E antibody)
  • Long-acting antibody designed to inhibit Activin E; IND-enabling activities underway.
  • First-in-human trials anticipated in the first half of 2027.
• IBIO-800 (myostatin × Activin A bispecific)
  • Bispecific antibody targeting myostatin and Activin A, among other ligands.
  • Development candidate nominated in June 2026; IND-enabling activities initiated.
• Amylin receptor antibody program (with AstralBio)
  • Development of DACRA/SARA antibodies with controlled amylin receptor activity and limited calcitonin receptor activity using engineered GPCR antigens and mammalian-display selection.
  • Early preclinical data in mice show reduced fat intake and differentiated receptor pharmacology.
• Licenses from AstralBio
  • Exclusive worldwide licenses to IBIO-600 and IBIO-610, plus an Amylin Licensed Product program, under separate agreements with AstralBio.
• RubrYc-related assets (historical)
  • Asset purchase in 2022 acquired RubrYc’s AI platform and several immune-oncology assets, including RTX-003/IBIO-101, additional preclinical antibodies, and a PD-1 agonist; prior collaboration agreements were terminated upon acquisition.

Technology and platform

iBio’s AI drug discovery platform includes:

• Epitope Steering: AI-designed engineered epitopes to steer antibody discovery toward defined functional regions of target proteins.
• StableHu: AI-driven optimization of antibody sequence diversity for expression, stability, and developability, combined with mammalian-display multidimensional screening.
• Mammalian display: Used to evaluate potency, specificity, cross-species binding, and developability.
• EngageTx: Platform for developing optimized CD3-based T-cell engagers and other complex formats.

The platform is designed to accelerate concept-to-development timelines, with hit generation occurring on shortened schedules.

Partnerships and licenses

• AstralBio agreements (exclusive licenses)
  • Myostatin (IBIO-600): $750,000 upfront; milestone payments up to $28 million (cash or stock-based, subject to exchange approvals and ownership caps); low-to-mid single-digit sublicense fees on third-party sublicenses.
  • Activin E (IBIO-610): $750,000 upfront credit used; milestone payments up to $28 million; sublicense fees.
  • Amylin Licensed Product: $750,000 upfront; milestone payments up to $28 million; sublicense fees.
  • AstralBio granted exclusivity worldwide and licensed patents and know-how to iBio for the respective targets.
• RubrYc (historical)
  • 2021 RTX-003 license and collaboration agreements; terminated upon the September 2022 asset purchase, which transferred RubrYc assets and platform to iBio.
• Intellectual property/licensing
  • Ongoing reliance on licensed patents and know-how from AstralBio for key programs, in addition to iBio’s owned and licensed IP.

Intellectual property portfolio

• Patent filings and assets covering antibody technologies and targets such as CCR8, EGFRvIII, MUC16, TROP-2, CD3, and conditionally-activated antibodies.
• Portfolio includes 16 U.S., 4 PCT, and 50 international patent applications with expirations generally between 2027 and 2042.
• Platform technologies include the Epitope Steering engine, StableHu optimization, and EngageTx for CD3-based bispecifics.

Corporate and operations

• Location and facilities
  • Principal offices and R&D facility in San Diego, CA; approximately 11,383 square feet leased since September 2022, serving as the primary site for AI/biologics discovery and translational work.
• Employees
  • 23 full-time employees as of August 27, 2026, plus 2 strategic consultants.
• Operations
  • Relies on external vendors for manufacturing and clinical execution consistent with a late-preclinical to early-clinical biotechnology company.

Financial highlights

• Fiscal year 2026 (year ended June 30, 2026)
  • Net loss: approximately $33.0 million.
  • R&D expense: about $19.6 million.
  • Accumulated deficit: approximately $365.3 million.
• Fiscal year 2025 (year ended June 30, 2025)
  • Net loss: approximately $18.4 million.
  • R&D expense: about $8.3 million.
• Capital and financing
  • August 2025 public offering: gross proceeds up to $100 million; net proceeds around $46.5 million.
  • January 2026 private investment: gross proceeds of $26 million.
  • Open Market Sale Agreement with Jefferies to sell up to $100 million of common stock (ATM facility initiated February 2026).
  • Ongoing ATM and related financing discussions.

Regulatory status

• IBIO-600 Phase 1 trial initiated in Australia with TGA CTN acknowledgment and HREC approvals; first participant dosed in June 2026 and 31 participants dosed across four SAD cohorts.
• IBIO-610 IND-enabling activities underway; first-in-human trials anticipated in the first half of 2027.
• IBIO-800 development candidate nominated in June 2026 with IND-enabling activities initiated.

Key outcomes to date

• Transitioned to a clinical-stage company in 2026 with IBIO-600 entering Phase 1 and initial dosing completed in June 2026.
• IND-enabling and preclinical activities advancing for IBIO-610 and IBIO-800.
• Amylin receptor program with AstralBio has produced early preclinical proof-of-concept signals.
• Completed multiple equity financings and established financing facilities to support development programs.

Contact and corporate information

• Incorporated in Delaware (originally iBioPharma, Inc. in 2008; renamed iBio, Inc. in 2009).
• Principal offices in San Diego, CA.
• Website: www.ibioinc.com