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IBIO-610 predicted human half-life up to 100 days at ObesityWeek

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

iBio, Inc. announced new preclinical pharmacokinetic data for IBIO-610, a potentially first-in-class Activin E antibody. In obese non-human primates, IBIO-610 showed an extended half-life of 33.2 days. Using an allometric scaling model for half-life–extended antibodies, the company reports a predicted human half-life of up to 100 days, which could lower dosing to once every six months and improve patient experience.

The data will be presented by Cory Schwartz, Ph.D., during an oral session at ObesityWeek 2025 in Atlanta, held November 4–7, 2025. The announcement was shared via press release furnished with this report, which includes forward-looking statement disclosures.

Positive

  • None.

Negative

  • None.

Insights

NHP PK shows long half-life; human benefit remains predictive.

iBio reports IBIO-610 half-life of 33.2 days in obese non-human primates. The company applies an allometric scaling model to estimate a human half-life of up to 100 days, implying potential twice-yearly dosing and a simpler treatment schedule.

These findings are preclinical and the 100-day figure is a model-based prediction. Real-world human pharmacokinetics can differ due to target engagement, distribution, and clearance characteristics not captured in animal data.

The next concrete step disclosed is an oral presentation at ObesityWeek on November 4–7, 2025 in Atlanta. Additional human data would be needed to validate dosing intervals and clinical utility.

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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): October 30, 2025

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 October 30, 2025, 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 supported by preclinical data. The data will be presented by Cory Schwartz, Ph.D., Director of Research and Early Development of the Company, during an oral session at ObesityWeek 2025, taking place November 4, 2025 through November 7, 2025 in Atlanta.

Results from the obese NHP study evaluating IBIO-610 are set forth below:

The pharmacokinetic data, to be presented at ObesityWeek, demonstrates IBIO-610 has an extended half-life in obese NHP of 33.2 days. Based on an allomeric scaling model of half-life extended antibodies, it is predicted IBIO-610 will have a half-life in humans of up to 100 days, reducing the dosing frequency to once every six months, which has the potential to significantly improve patient experience.

Graphic

PK of IBIO-610 in NHPs and Allometric Scaling Predicting Human Half-life

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 30, 2025, 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 supported by preclinical data. The data will be presented by Cory Schwartz, Ph.D., Director of Research and Early Development of the Company, during an oral session at ObesityWeek 2025, taking place November 4, 2025 through November 7, 2025 in Atlanta.

Results from the obese NHP study evaluating IBIO-610 are set forth below:

The pharmacokinetic data, to be presented at ObesityWeek, demonstrates IBIO-610 has an extended half-life in obese NHP of 33.2 days. Based on an allomeric scaling model of half-life extended antibodies, it is predicted IBIO-610 will have a half-life in humans of up to 100 days, reducing the dosing frequency to once every six months, which has the potential to significantly improve patient experience.

Graphic

PK of IBIO-610 in NHPs and Allometric Scaling Predicting Human Half-life

Item 9.01.     Financial Statements and Exhibits.

(d)    Exhibits.

Exhibit
Number

    

 Description

99.1

Press Release issued by iBio, Inc., dated October 30, 2025

104

Cover Page Interactive Data File (embedded within the XBRL document)

SIGNATURES

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

 Date: October 30, 2025

IBIO, INC.

 

 

By: 

/s/ Marc A. Banjak

 

 

Name:

Marc A. Banjak

Title:

Chief Legal Counsel

FAQ

What did iBio (IBIO) announce in its 8-K?

The company announced new preclinical pharmacokinetic data for IBIO-610, showing a 33.2-day half-life in obese non-human primates.

What is IBIO-610?

IBIO-610 is a potentially first-in-class Activin E antibody candidate supported by preclinical data.

What were the key NHP results for IBIO-610?

Pharmacokinetic data indicate an extended half-life of 33.2 days in obese non-human primates.

What is the predicted human half-life for IBIO-610?

Based on allometric scaling of half-life extended antibodies, the predicted human half-life is up to 100 days.

How often could IBIO-610 be dosed in humans based on the model?

The company states the prediction could enable dosing once every six months, potentially improving patient experience.

Where and when will the data be presented?

An oral session at ObesityWeek 2025 in Atlanta from November 4–7, 2025, presented by Cory Schwartz, Ph.D.

Does the announcement include forward-looking statements?

Yes. The press release furnished with the report includes safe harbor language indicating certain statements are forward-looking.
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