IBIO 8-K
iBio, Inc. (IBIO)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Item 7.01. Regulation FD Disclosure.
On April 8, 2026, iBio, Inc. (the “Company”) issued a press release announcing that it received Clinical Trial Notification acknowledgement from Australia’s Therapeutic Goods Administration and ethics approval from a Human Research Ethics Committee, enabling the initiation of a first-in-human clinical trial of IBIO-600 in Australia. First participants are expected to be dosed in the second quarter of 2026.
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 April 8, 2026, the Company issued a press release announcing (the “Public Announcement”) that it received Clinical Trial Notification acknowledgement from Australia’s Therapeutic Goods Administration and ethics approval from a Human Research Ethics Committee, enabling the initiation of a first-in-human clinical trial of IBIO-600 in Australia to initiate its Phase 1 clinical trial of IBIO-600 in Australia. First participants are expected to be dosed in the second quarter of 2026.
As previously disclosed, on August 19, 2025, the Company issued and sold pre-funded warrants (the “2025 Pre-Funded Warrants”) to purchase an aggregate of up to 71,540,000 shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”) and accompanying Series G warrants (the “Series G Warrants”) to purchase (i) an aggregate of up to 35,770,000 shares of Common Stock (or, for those investors who so chose, pre-funded warrants to purchase up to 35,770,000 shares of Common Stock in lieu thereof) and (ii) Series H warrants (the “Series H Warrants”) to purchase an aggregate of up to 35,770,000 shares of Common Stock (or, for those investors who so chose, pre-funded warrants to purchase up to 35,770,000 shares of Common Stock in lieu thereof) (the “2025 Offering”).
The terms of the Series G Warrants provide that such warrants expire on the date that is the earlier of (i) 30 trading days following the Company’s Public Announcement, via a press release on a nationally recognized news wire or the filing of a Current Report on Form 8-K with the Securities and Exchange Commission, that an Investigational New Drug application filed with the U.S. Food and Drug Administration, a Clinical Trial Notification filed with the applicable foreign governmental body in Australia, a Clinical Trial Application filed with the European Medicines Agency or an equivalent submission filed with a foreign governmental body to initiate a clinical trial in any other foreign jurisdiction, has been accepted or has otherwise gone into effect, as applicable; and (ii) five years from the date of issuance. As a result of the Public Announcement, the Series G Warrants will expire on May 12, 2026, 30 trading days following the Public Announcement. When issued upon exercise of the Series G Warrants, the Series H Warrants will expire on the four-year anniversary of the closing date of the 2025 Offering.
As of the date of this Current Report on Form 8-K, there are outstanding Series G Warrants to purchase (i) an aggregate of up to 27,945,000 shares of Common Stock. If all of the currently outstanding Series G Warrants were exercised into shares of Common Stock prior to their expiration date, an additional 27,945,000 shares of Common Stock will be issued, in addition to Series H Warrants to purchase an aggregate of up to 27,945,000 shares of Common Stock (or pre-funded warrants in lieu thereof).
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: April 8, 2026 | IBIO, INC. | ||
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By: | /s/ Marc A. Banjak | ||
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| Name: | Marc A. Banjak |
Title: | Chief Legal Officer | ||
Exhibit 99.1
iBio Received Regulatory Clearance to Initiate Its Phase 1 Clinical Trial of IBIO-600 in Australia
IBIO-600 is a potentially best-in-class, long-acting anti-myostatin monoclonal antibody designed to preserve muscle and improve body composition
First participants expected to be dosed in 2Q 2026
SAN DIEGO, CA, April 8, 2026 -- iBio, Inc. (NASDAQ: IBIO) (“iBio” or “the Company”), an AI-driven innovator developing therapies for cardiometabolic, obesity and cardiopulmonary diseases, today announced IBIO-600 has received Clinical Trial Notification (CTN) acknowledgement from Australia’s Therapeutic Goods Administration (TGA) and ethics approval from a Human Research Ethics Committee (HREC), enabling the initiation of a first-in-human clinical trial of IBIO-600 in Australia.
The Phase 1 study is a randomized, double-blind, placebo-controlled, single ascending dose trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBIO-600 in overweight and obese adult participants. iBio expects to dose the first participant in the second quarter of 2026.
“This is a defining milestone for iBio as we transition to a clinical-stage company,” said Martin Brenner, D.V.M., Ph.D., Chief Executive Officer and Chief Scientific Officer of iBio. “While GLP-1 therapies have transformed the treatment landscape, significant gaps remain, particularly around the loss of muscle mass. We believe IBIO-600 has the potential to address this unmet need. Advancing IBIO-600 into the clinic only two years after program initiation also reflects the capabilities of our AI-integrated discovery platform and our team’s execution.”
IBIO-600 is a long-acting monoclonal antibody targeting myostatin and GDF11, negative regulators of skeletal muscle growth, and is designed to preserve lean mass and improve body composition in obesity. The therapy has the potential to be used alongside GLP-1 therapies to address muscle loss associated with weight reduction. IBIO-600 has been engineered for infrequent dosing, with the potential for administration two to four times per year.
Previously announced preclinical studies in non-human primates demonstrated sustained pharmacologic activity and an extended half-life of 40–52 days following a single administration, as well as dose-dependent increases in lean mass of up to 5.1%. These findings, observed alongside reductions in fat mass and durable effects over time, support the advancement of IBIO-600 into clinical development.
About iBio, Inc.
iBio (Nasdaq: IBIO) is a cutting-edge biotech company leveraging AI and advanced computational biology to develop next-generation biopharmaceuticals for cardiometabolic and cardiopulmonary diseases, obesity, cancer and other hard-to-treat diseases. By combining proprietary 3D modeling with innovative drug discovery platforms, iBio is creating a pipeline of breakthrough antibody treatments to 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 iBio 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’s initiation of a first-in-human clinical trial of IBIO-600 in Australia; iBio dosing the first participant in the second quarter of 2026; IBIO-600 having the potential to address an unmet need, particularly around the loss of muscle mass; IBIO-600, a long-acting anti-myostatin monoclonal antibody, preserving muscle and improving body composition; IBIO-600 having the potential to be used alongside GLP-1 therapies to address muscle loss associated with weight reduction; IBIO-600 potentially being administered as infrequently as two to four times per year; iBio developing next-generation biopharmaceuticals for cardiometabolic, obesity and cardiopulmonary diseases, cancer and other hard-to-treat diseases; iBio creating a pipeline of breakthrough antibody treatments to address significant unmet medical needs; and iBio’s ability to transform drug discovery, accelerate development timelines, and unlock new possibilities in precision medicine 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 iBio to meet the timing for dosing the first patient in the second quarter of 2026; the ability of iBio’s innovative pipeline of therapeutics in cardiometabolic disease and obesity to promote healthy weight loss and muscle-building; the ability of IBIO-600 to address an unmet need, particularly around the loss of muscle mass; IBIO-600, a long-acting anti-myostatin monoclonal antibody, preserving muscle and improving body composition; and IBIO-600 having the potential to be used alongside GLP-1; iBio’s ability to create a pipeline of breakthrough antibody treatments to address significant unmet medical needs; 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
[email protected]
Media Contacts:
Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
[email protected]
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(858) 717-2310 or (646) 942-5604