Item 7.01. Regulation FD Disclosure.
On October 13, 2026, iBio, Inc. (the “Company”) issued a press release highlighting preclinical body-composition data from its eight week obese non-human primate (“NHP”) study evaluating IBIO-610, potentially a first-in-class Activin E antibody candidate. The data were discussed in an oral presentation at the European Association for the Study of Diabetes Annual Meeting on October 1, 2026.
In this NHP study, lean mass made up 6% of weight loss with IBIO-610 plus semaglutide, verses 22% with semaglutide alone and IBIO-610 delivered durable, near-complete inhibition of active Activin E, and when combined with semaglutide, nearly all observed weight loss came from fat. Additional analysis of the eight-week obese NHP study (n=6 per group) further characterized the potential for IBIO-610 to support muscle preservation when combined with semaglutide. At week 8, fat accounted for 93% of the weight lost by NHPs given a single dose of IBIO-610 alongside twice-weekly semaglutide, compared with 77% for NHPs given semaglutide alone.
These results build on previously reported data from this NHP study, in which IBIO-610 demonstrated a 97% reduction in serum levels of active Activin E at week 8 following a single intravenous dose. The study also found that IBIO-610 had a 33.2-day half-life in NHPs, with a projected human half-life potentially supporting twice-yearly dosing. The Company plans to begin first-in-human studies in the first half of 2027.
The information in this Item 7.01 and in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended and shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.
Item 8.01. Other Events.
On October 13, 2026, the Company issued a press release highlighting preclinical body-composition data from its obese NHP study evaluating IBIO-610, potentially a first-in-class Activin E antibody candidate. The data were discussed in an oral presentation at the European Association for the Study of Diabetes Annual Meeting on October 1, 2026.
In this NHP study, lean mass made up 6% of weight loss with IBIO-610 plus semaglutide, verses 22% with semaglutide alone and IBIO-610 and IBIO-610 delivered durable, near-complete inhibition of active Activin E, and when combined with semaglutide, nearly all observed weight loss came from fat. Additional analysis of the eight-week obese NHP study (n=6 per group) further characterized the potential for IBIO-610 to support muscle preservation when combined with semaglutide. At week 8, fat accounted for 93% of the weight lost by NHPs given a single dose of IBIO-610 alongside twice-weekly semaglutide, compared with 77% for NHPs given semaglutide alone.
These results build on previously reported data from this NHP study, in which IBIO-610 demonstrated a 97% reduction in serum levels of active Activin E at week 8 following a single intravenous dose. The study also found that IBIO-610 had a 33.2-day half-life in NHPs, with a projected human half-life potentially supporting twice-yearly dosing. The Company plans to begin first-in-human studies in the first half of 2027.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| | |
Exhibit No. | | Description |
99.1 | | Press Release issued by iBio, Inc., dated October 13, 2026 |
104 | | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
