Received regulatory clearance to initiate its Phase 1 clinical trial of IBIO-600 in
Announced a strategic pipeline expansion into pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF) of its bispecific antibody
Reported new preclinical data from its obese non-human primate (NHP) study evaluating IBIO-610, with visceral fat reduced by 6.7% and total fat mass by 5.2%
“This last quarter was marked by significant advancement across our full pipeline. Most importantly, we received the clearance to enter the clinic with IBIO-600, which we believe has best-in-class potential due to its ability to preserve lean mass and improve body composition in obesity,” said
Third Fiscal Quarter 2026 & Recent Corporate Updates:
- Announced receipt of Clinical Trial Notification (CTN) acknowledgement from Australia’s
Therapeutic Goods Administration (TGA) andHuman Research Ethics Committee (HREC) approval to initiate a first-in-human Phase 1 clinical trial of IBIO-600, a long-acting anti-myostatin monoclonal antibody designed to preserve lean mass and improve body composition. The randomized, double-blind, placebo-controlled, single ascending dose study will evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of IBIO-600 in overweight and obese adults, with first participant dosing expected in the second quarter of calendar 2026. - Announced a strategic pipeline expansion into pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF). iBio is engineering a selective bispecific antibody designed to block Activin A, GDF8 (myostatin), and GDF11 to reduce cardiac fibrosis, reverse pulmonary vascular remodeling, and improve whole body functional capacity, while avoiding safety issues linked to broader TGFß ligand blockade.
- Presented new preclinical data from its obese non-human primate (NHP) study evaluating IBIO-610, potentially a first-in-class Activin E antibody candidate. The preclinical body composition data demonstrate IBIO-610 reduced fat mass in obese NHPs compared to vehicle-treated obese NHPs, in a small, not statistically powered study. Following two once-every-eight-week dosing, IBIO-610 reduced visceral fat by 6.7% and total fat mass by 5.2%, with only a slight increase in lean mass following treatment.
- Delivered an oral presentation at Drug R&D on
February 24, 2026 , titled “Accelerating Antibody Drug Discovery with Artificial Intelligence.” - Delivered a company presentation at Biocom California's
Global Life Science Partnering & Investor Conference onFebruary 25, 2026 . - Participated in fireside chats at the
Leerink Global Healthcare Conference and the Oppenheimer 36th AnnualHealthcare Life Sciences Conference .
Financial Results:
No revenue was recognized for the three months ended
Research and Development (“R&D”) expenses for the three months ended
General and Administrative expenses for the three months ending
iBio held cash, cash equivalents and investments in debt securities of
About
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 the potential of IBIO-600 to be best-in-class; IBIO-600’s ability to preserve lean mass and improve body composition in obesity; the significant potential of the Company’s platform and its commitment to developing differentiated therapies to meaningfully impact the lives of patients; initiation of a first-in-human Phase 1 clinical trial of IBIO-600, the potential of IBIO-600 to be a best-in-class, long-acting anti-myostatin monoclonal antibody; evaluation of the safety, tolerability, pharmacokinetics, and pharmacodynamics of IBIO-600 in overweight and obese adults in a randomized, double-blind, placebo-controlled, single ascending dose study; the dosing of the first participant in the IBIO-600 Phase 1 clinical trial in the second quarter of calendar 2026; iBio’s engineering of a selective bispecific antibody designed to block Activin A, GDF8 (myostatin), and GDF11; the selective bispecific antibody reducing cardiac fibrosis, reversing pulmonary vascular remodeling, and improving whole body functional capacity, while avoiding safety issues linked to broader TGFß ligand blockade; the potential of IBIO-610 to be a first-in-class Activin E antibody candidate; the net proceeds of the warrant exercises in the fourth quarter of fiscal year 2026 extending the Company’s cash runway into fourth quarter of fiscal year 2028; the Company’s ability to leverage AI and advanced computational biology to develop next-generation biopharmaceuticals for cardiometabolic and cardiopulmonary diseases, obesity, cancer and other hard-to-treat diseases; iBio’s ability to combine its proprietary 3D modeling with its innovative drug discovery platforms to create 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 initiate a first-in-human Phase 1 clinical trial of IBIO-600, with the dosing of the first participant in the IBIO-600 Phase 1 clinical trial in the second quarter of calendar 2026; 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
Contact:
iBio, Inc.
Investor Relations
ir@ibioinc.com
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310 or (646) 942-5604
| iBio, Inc. and Subsidiaries Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited; in thousands, except per share amounts) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Revenue | $ | — | $ | — | $ | 100 | $ | 200 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,254 | 1,906 | 11,084 | 5,088 | ||||||||||||
| General and administrative | 5,111 | 2,973 | 12,777 | 8,516 | ||||||||||||
| Total operating expenses | 8,365 | 4,879 | 23,861 | 13,604 | ||||||||||||
| Operating loss | (8,365 | ) | (4,879 | ) | (23,761 | ) | (13,404 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 657 | 72 | 1,417 | 358 | ||||||||||||
| Interest expense | (22 | ) | (54 | ) | (99 | ) | (168 | ) | ||||||||
| Total other income (expense) | 635 | 18 | 1,318 | 190 | ||||||||||||
| Net loss | $ | (7,730 | ) | $ | (4,861 | ) | $ | (22,443 | ) | $ | (13,214 | ) | ||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (7,730 | ) | $ | (4,861 | ) | $ | (22,443 | ) | $ | (13,214 | ) | ||||
| Other comprehensive loss - unrealized loss on on debt securities | (32 | ) | — | (21 | ) | — | ||||||||||
| Comprehensive loss | $ | (7,762 | ) | $ | (4,861 | ) | $ | (22,464 | ) | $ | (13,214 | ) | ||||
| Loss per common share - basic and diluted | $ | (0.07 | ) | $ | (0.49 | ) | $ | (0.26 | ) | $ | (1.44 | ) | ||||
| Weighted-average common shares outstanding - basic and diluted - see Note 16 | 117,470 | 9,862 | 86,048 | 9,202 | ||||||||||||
| iBio, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) | ||||||||
| March31, | June30, | |||||||
| 2026 | 2025 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 47,631 | $ | 8,582 | ||||
| Accounts receivable - trade, net of allowance for credit losses of | — | — | ||||||
| Investments in debt securities (adjusted cost | 27,166 | — | ||||||
| Subscription receivable | — | 105 | ||||||
| Prepaid expenses and other current assets | 2,454 | 1,034 | ||||||
| Total Current Assets | 77,251 | 9,721 | ||||||
| Restricted cash | 228 | 210 | ||||||
| Promissory note receivable | 1,157 | 1,098 | ||||||
| Finance lease right-of-use assets, net of accumulated amortization | — | 68 | ||||||
| Operating lease right-of-use asset | 1,766 | 2,051 | ||||||
| Fixed assets, net of accumulated depreciation | 3,310 | 3,163 | ||||||
| Intangible assets, net of accumulated amortization | 1,830 | 6,848 | ||||||
| Prepaid expenses - noncurrent | 282 | — | ||||||
| Security deposits | 10 | 26 | ||||||
| Total Assets | $ | 85,834 | $ | 23,185 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,035 | $ | 2,188 | ||||
| Accrued expenses | 1,787 | 1,345 | ||||||
| Finance lease obligations | — | 53 | ||||||
| Operating lease obligation - current portion | 532 | 490 | ||||||
| Equipment financing payable - current portion | — | 64 | ||||||
| Term promissory note | — | 766 | ||||||
| Contract liabilities | 1,150 | 1,200 | ||||||
| Total Current Liabilities | 6,504 | 6,106 | ||||||
| Operating lease obligation - net of current portion | 1,793 | 2,199 | ||||||
| Total Liabilities | 8,297 | 8,305 | ||||||
| Stockholders' Equity | ||||||||
| Preferred Stock - | — | — | ||||||
| Common Stock - | 35 | 19 | ||||||
| Additional paid-in capital | 432,190 | 347,085 | ||||||
| Accumulated other comprehensive loss | (21 | ) | — | |||||
| Accumulated deficit | (354,667 | ) | (332,224 | ) | ||||
| Total Stockholders’ Equity | 77,537 | 14,880 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 85,834 | $ | 23,185 | ||||
