お知らせ • Apr 08
iBio, Inc. Receives Regulatory Clearance to Initiate Its Phase 1 Clinical Trial of Ibio-600 in Australia iBio, Inc. 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. 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. Recent Insider Transactions • Mar 24
Chief Financial Officer recently bought US$50k worth of stock On the 19th of March, Felipe Duran bought around 25k shares on-market at roughly US$2.02 per share. This transaction increased Felipe's direct individual holding by 2x at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Felipe's only on-market trade for the last 12 months. お知らせ • Mar 23
INB.bio Launches Rebuilt Ai-Powered Affiliate Crm Platform INB.bio has launched its 2026 growth strategy. Plans include a market entry into Tanzania, expansion into three to five new countries across Africa and Southeast Asia, and the rollout of a rebuilt AI-powered affiliate CRM platform designed to support rapid multi-market operations. The company, which manufactures and distributes an exclusive portfolio of wellness products covering men's health, joint support, weight management, immunity, and cardiovascular health, enters 2026 having built one of the most operationally complete direct advertiser models in its category. Its infrastructure in each active market includes native call centers, owned logistics networks, and a proprietary technology platform built for cash-on-delivery economies where digital payment access is limited. The company is simultaneously launching a turnkey partner program through which high-performing affiliate partners can co-develop new country operations alongside INB.bio. Participants receive exclusive geographic access, native call center resources, owned logistics support, and live performance data through an upgraded affiliate dashboard. Payouts are processed twice weekly, on Tuesdays and Fridays, with a minimum threshold of fifty dollars in USDT TRC-20, and additional payment options, including wire transfer and PayPal, are in development. お知らせ • Mar 18
iBioInc Provides Update on Cardiopulmonary Program Targeting Pulmonary Hypertension Associated with Heart Failure with Preserved Ejection Fraction iBio, Inc. announced the Company will host a conference call on Tuesday, March 17, at 4 p.m. ET. The conference call will address iBio’s strategic pipeline expansion into pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF) and will include a presentation from Martin Brenner, DVM, Ph.D., iBio’s Chief Executive Officer and Chief Scientific Officer, and Cory Schwartz, Ph.D., the Company’s Director of Research and Early Development. 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 TGF-ß ligand blockade. iBio’s bispecific approach is intentionally designed to target multiple core drivers of PH-HFpEF biology simultaneously, a gap among currently approved PH-HFpEF therapies. iBio expects to declare the optimized bispecific antibody development candidate for PH-HFpEF (validated for potency, selectivity, manufacturability, and in vivo efficacy) in the third quarter of calendar 2026 before entering IND-enabling activities. The webcast of the call may be accessed on the Investors section of the iBio website. A replay of the webcast will be available on the iBio website following the presentation. To join the live call, participants need to access this link for dial-in numbers and a unique participation code. Heart failure with preserved ejection fraction (HFpEF) is a heterogeneous syndrome in which the heart continues to pump with a preserved ejection fraction but becomes impaired in its ability to relax and fill properly. HFpEF accounts for approximately half of all heart failure cases and is closely associated with obesity, diabetes, hypertension, and aging. Pulmonary hypertension associated with HFpEF (PH-HFpEF) is a clinically severe subtype linked to pulmonary vascular remodeling, reduced functional capacity, and poor prognosis. While current therapies have benefited many patients, there remains a significant unmet need for treatments that more directly modify the underlying drivers of disease. iBio’s bispecific antibody program targets three closely related ligands—myostatin (GDF8), GDF11, and Activin A, that sit at the intersection of skeletal muscle health, metabolic function, cardiac fibrosis, and vascular remodeling. Because these pathways can drive disease in both obesity/weight-loss–related dysfunction and PH-HFpEF, iBio believes that the same selective mechanism of action may address both areas. お知らせ • Mar 10
IBio Inc Reports Preclinical Body Composition Data From Obese Non-Human Primates Treated With IBIO-610 IBio, Inc. announced 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 demonstrates 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 up-tick in lean mass following treatment. This fat-selective profile in NHP study is consistent with the effects The company previously observed in rodents and with body composition outcomes reported by other companies in human clinical trials targeting the Activin E pathway. These data support continued evaluation of IBIO-610’s potential as a differentiated therapy in obesity, cardiometabolic and cardiopulmonary diseases. Previously reported data from the study demonstrated IBIO-610’s extended 33.2-day half-life in obese NHPs and a projected human half-life of up to 100 days, supporting the potential for convenient, twice-yearly dosing. The complete dataset, which will include analysis of additional biomarkers, will be presented by iBio at scientific conferences throughout 2026. These findings are consistent with body composition effects reported for therapies targeting the Activin E pathway, including human siRNA approaches. The company believe IBIO-610’s fat-selective biology supports its potential to drive targeted fat loss while maintaining lean mass. Team is continuing its thorough analyses of the dataset spanning metabolic, biomarker, and mechanistic endpoints, and the company look forward to presenting additional insights. New Risk • Mar 03
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 22% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (23% average weekly change). Earnings are forecast to decline by an average of 22% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (250% increase in shares outstanding). Revenue is less than US$1m (US$300k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$49m net loss in 3 years). Market cap is less than US$100m (US$92.9m market cap).