iBio (NASDAQ: IBIO) obesity antibody cuts Activin E and spares lean mass

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Form Type

8-K

Rhea-AI Filing Summary

iBio, Inc. reported new preclinical results from an obese non-human primate study of IBIO-610, a potentially first-in-class Activin E antibody for obesity and related diseases. After a single dose, active Activin E in blood fell in all treated animals and stayed suppressed for eight weeks.

Active Activin E levels were reduced by 98% at week 4 and 97% at week 8 compared with baseline, with levels below the limits of the assay at both time points. The company states this supports the potential for strong pathway inhibition and an infrequently dosed, long-acting antibody.

The data also suggest IBIO-610 may promote fat-selective weight loss while preserving lean mass. In obese primates, adding IBIO-610 to semaglutide produced greater visceral and total fat loss and cut lean mass loss by 73% versus semaglutide alone, supporting its potential as both a stand-alone and GLP-1-complementary therapy. The full dataset will be presented at the 2026 EASD Annual Meeting in Milan.

Insights

Preclinical NHP data show strong target engagement and body-composition effects but remain early-stage.

iBio describes a single dose of IBIO-610 in obese non-human primates reducing active Activin E by up to 98% at week 4 and 97% at week 8, with levels below assay limits. This indicates robust target engagement for an Activin E antibody aimed at obesity and cardiometabolic disease.

The study also reports greater visceral and total fat loss, plus a 73% reduction in lean mass loss versus semaglutide alone when IBIO-610 is combined with semaglutide. That supports management’s positioning of IBIO-610 as a potentially long-acting, fat-selective, GLP-1-complementary approach, though all results are preclinical.

The company plans to present the full dataset at the European Association for the Study of Diabetes Annual Meeting between September 28 and October 2, 2026. Subsequent disclosures from that presentation and any human trial plans will be important to understand how these NHP findings might translate clinically.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Key Figures

Activin E reduction week 4: 98% reduction Activin E reduction week 8: 97% reduction Lean mass loss reduction: 73% less lean mass loss +2 more

5 metrics

Activin E reduction week 4 98% reduction Overall active Activin E reduction at week 4 vs baseline

Activin E reduction week 8 97% reduction Overall active Activin E reduction at week 8 vs baseline

Lean mass loss reduction 73% less lean mass loss IBIO-610 plus semaglutide vs semaglutide alone in obese NHPs

Suppression duration Eight weeks Active Activin E remained suppressed through eight weeks after single dose

Conference dates September 28 – October 2, 2026 EASD Annual Meeting presentation of full IBIO-610 dataset in Milan

Key Terms

Activin E antibody, non-human primate (NHP), GLP-1-based treatments, European Association for the Study of Diabetes, +1 more

5 terms

Activin E antibody medical

"evaluating IBIO-610, potentially a first-in-class Activin E antibody candidate"

non-human primate (NHP) medical

"new preclinical data from its obese non-human primate ("NHP") study evaluating IBIO-610"

Non-human primate (NHP) refers to monkeys, apes or other primate species used in medical research to test safety and effectiveness before treatments are given to people. Because their biology is closer to humans than other lab animals, results from NHP studies can strongly influence whether regulators allow human trials, how quickly a drug advances, and the cost, timing and risk profile investors use to value biotech projects — like a dress rehearsal that helps predict real-world performance.

GLP-1-based treatments medical

"supporting its potential as both a stand-alone therapy and a complementary approach to GLP-1-based treatments"

European Association for the Study of Diabetes medical

"presentation at the 62nd Annual Meeting of the European Association for the Study of Diabetes"

forward-looking statements regulatory

"Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws"

Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.

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Understanding 8-K Material Events →

Available on EDGAR 07/01/2026 - 07:33 AM Accepted by SEC EDGAR 07/01/2026 - 07:33 AM

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (date of earliest event reported): July 1, 2026

iBio, Inc.

(Exact name of registrant as specified in charter)

Delaware

(State or other jurisdiction of incorporation)


001-35023	26-2797813
(Commission File Number)	(IRS Employer Identification No.)

11750 Sorrento Valley Road, Suite 200

San Diego, California 92121

(Address of principal executive offices and zip code)

(979) 446-0027

(Registrant’s telephone number including area code)

N/A

(Former Name and Former Address)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12(b) under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.001 par value per share	IBIO	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 7.01. Regulation FD Disclosure.

On July 1, 2026, iBio, Inc. (the “Company”) issued a press release announcing new preclinical data from its obese non-human primate (“NHP”) study evaluating IBIO-610, potentially a first-in-class Activin E antibody candidate.

Following a single dose of IBIO-610, active Activin E levels in the blood were reduced in all treated NHPs and remained suppressed through eight weeks. At both weeks 4 and 8, active Activin E levels were reduced to levels below the limits of the assay. Overall, active Activin E was reduced by 98% at week 4 and 97% at week 8 compared with baseline. These findings support IBIO-610's potential for best-in-class pathway inhibition and further support the potential for an infrequently dosed, long-acting antibody approach.

The data also demonstrated IBIO-610's potential to promote fat-selective weight loss while preserving lean mass. In obese NHPs, when combined with semaglutide, IBIO-610 drove greater visceral and total fat loss while reducing lean mass loss by 73% versus semaglutide alone, further supporting its potential as both a stand-alone therapy and a complementary approach to GLP-1-based treatments.

The full data will be highlighted in a presentation at the 62nd Annual Meeting of the European Association for the Study of Diabetes, taking place September 28 – October 2 in Milan.

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 July 1, 2026, the Company issued a press release announcing new preclinical data from its obese NHP study evaluating IBIO-610, potentially a first-in-class Activin E antibody candidate.

The full data will be highlighted in a presentation at the 62nd Annual Meeting of the European Association for the Study of Diabetes, taking place September 28 – October 2 in Milan, Italy.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.


Exhibit No.		Description
99.1		Press Release issued by iBio, Inc. July 1, 2026

-1-

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


	IBIO, INC.

Date: July 1, 2026	By:	/s/ Marc Banjak
		Name:	Marc Banjak
		Title:	Chief Legal Officer

-2-

Exhibit 99.1

iBio Reports Single Dose of IBIO-610 Achieved Near-Complete Active Activin E Inhibition Through Eight Weeks in Obese NHP Study

Single-dose IBIO-610 achieved up to 98% inhibition of active Activin E through eight weeks, supporting a differentiated, long-acting antibody approach

When combined with semaglutide, IBIO-610 drove greater visceral and total fat loss while reducing lean mass loss by 73% versus semaglutide alone

Full dataset to be presented at European Association for the Study of Diabetes (EASD) Annual Meeting

SAN DIEGO, Jul. 1, 2026 (GLOBE NEWSWIRE) -- iBio, Inc. (NASDAQ: IBIO), a clinical-stage biotechnology developing long-acting antibody therapeutics for obesity, cardiometabolic and cardiopulmonary diseases, today announced new preclinical data from its obese non-human primate (NHP) study evaluating IBIO-610, potentially a first-in-class Activin E antibody candidate.

“These latest NHP data represent another key point in the advancement of IBIO-610 as a potentially differentiated antibody approach,” said Martin Brenner, DVM, Ph.D., Chief Executive Officer and Chief Scientific Officer of iBio. “We are particularly encouraged to see what we believe is the highest degree of Activin E inhibition reported to date for a molecule in this class and achieved following a single dose. This level of inhibition supports the potential for low-frequency dosing to improve the patient experience. We believe Activin E blockade represents an important opportunity for iBio as the obesity market continues to evolve toward more durable and body-composition-focused therapies.”

The full data will be highlighted in a presentation at the 2026 EASD Annual Meeting, taking place September 28 – October 2 in Milan. Details of the presentation are listed below:

Session: Short Oral Discussion Event E

Short Oral Discussion Session: SO 065 Novel agents: mechanisms and emerging therapies

Date and time: Thursday, October 1, 12:45 p.m. – 13:45 p.m. ET

Location: Short Oral Discussion Station 11

Presentation Title and Number: Antibody-mediated blockade of Activin E improves body composition in obese non-human primates – 759

Presenter: Cory Schwartz, Ph.D., Vice President of Research and Early Development at iBio

About iBio, Inc.

iBio (Nasdaq: IBIO) is a clinical-stage biotechnology developing long-acting antibody therapeutics for obesity, cardiometabolic and cardiopulmonary diseases, cancer, and other hard-to-treat diseases. Combining advanced antibody engineering with AI-driven discovery, iBio is advancing a differentiated pipeline designed to deliver sustained therapeutic effects and address significant unmet medical needs. iBio’s mission is to transform drug discovery, accelerate development timelines, and unlock new possibilities in precision medicine.

For more information, visit www.ibioinc.com or follow us on LinkedIn.

Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are based upon current estimates and assumptions and include statements regarding IBIO-610's potential for best-in-class pathway inhibition and the potential for an infrequently dosed, long-acting antibody approach; IBIO-610's potential to promote fat-selective weight loss while preserving lean mass; IBIO-610’s potential as both a stand-alone therapy and a complementary approach to GLP-1-based treatments; IBIO-610 potential differentiated antibody approach; the data being the highest degree of Activin E inhibition reported to date for a molecule in this class and achieved following a single dose; the data supporting the potential for low-frequency dosing to improve the patient experience and the Activin E blockade representing an important opportunity for iBio as the obesity market continues to evolve toward more durable and body-composition-focused therapies While iBio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the ability of Activin E to be a successful target for cardiometabolic disorders and obesity and iBio’s antibody to induce fat-selective weight loss and offer protection against obesity and cardiometabolic disease; the ability to produce similar data in human clinical trials; iBio’s ability to obtain regulatory approvals for commercialization of its product candidates, or to comply with ongoing regulatory requirements; regulatory limitations relating to iBio’s ability to promote or commercialize its product candidates for specific indications; acceptance of iBio’s product candidates in the marketplace and the successful development, marketing or sale of products; and whether iBio will incur unforeseen expenses or liabilities or other market factors; and the other factors discussed in iBio’s filings with the SEC including its Annual Report on Form 10-K for the year ended June 30, 2025 and its subsequent filings with the SEC on Forms 10-Q and 8-K. The information in this release is provided only as of the date of this release, and iBio

undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Corporate Contact:
iBio, Inc.
Investor Relations
ir@ibioinc.com

Media Contacts:
Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310 or (646) 942-5604

Source: View Original Filing on SEC EDGAR

FAQ

What did iBio (IBIO) report about its IBIO-610 obesity antibody in this 8-K?

iBio reported new obese non-human primate data for IBIO-610 showing a single dose cut active Activin E by up to 98% through eight weeks. The company says this supports a long-acting antibody approach for obesity and related cardiometabolic diseases.

How much did IBIO-610 reduce Activin E levels in the obese primate study?

In the obese non-human primate study, a single IBIO-610 dose reduced active Activin E by 98% at week 4 and 97% at week 8 versus baseline. Levels were below the assay’s detection limits at both week 4 and week 8.

How did IBIO-610 perform in combination with semaglutide according to iBio?

When combined with semaglutide in obese primates, IBIO-610 produced greater visceral and total fat loss while preserving lean mass. Lean mass loss was reduced by 73% versus semaglutide alone, supporting potential stand-alone and GLP-1-complementary use.

What potential advantages does iBio see for IBIO-610 in obesity treatment?

iBio highlights IBIO-610’s potential for best-in-class Activin E pathway inhibition and an infrequently dosed, long-acting antibody profile. The company also emphasizes possible fat-selective weight loss with lean mass preservation, which could be attractive as obesity therapies evolve.

When and where will iBio present the full IBIO-610 preclinical dataset?

The full IBIO-610 obese primate dataset will be presented at the 62nd Annual Meeting of the European Association for the Study of Diabetes. The conference runs from September 28 to October 2, 2026, in Milan, Italy, in a short oral discussion session.

Does this iBio update involve human clinical trial results for IBIO-610?

No, the update relates to preclinical obese non-human primate data for IBIO-610, an Activin E antibody candidate. iBio describes effects on Activin E suppression, fat and lean mass in animals, and outlines plans to present the dataset at a scientific meeting.

Filing Exhibits & Attachments

5 documents

Press Releases

EX-99.1 EX-99.1 13.5 KB

iBio (NASDAQ: IBIO) obesity antibody cuts Activin E and spares lean mass

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