1.   Nature of Business

iBio, Inc. (“we”, “us”, “our”, “iBio”, “iBio, Inc” or the “Company”) is a developer of next-generation biopharmaceuticals and the pioneer of the sustainable FastPharming^® Manufacturing System. The Company is applying its technologies to research and develop novel product candidates to treat or prevent fibrotic diseases, cancers, and infectious diseases. The Company is using its FastPharming Manufacturing System (“FastPharming” or the “FastPharming System”) and Glycaneering^SM Services to help rapidly and cost effectively build a portfolio of biologic drug candidates, as well as to create proteins for others by contract or via the Company’s catalog.

The FastPharming System is the Company’s proprietary approach to plant-made pharmaceutical and recombinant protein production. It uses hydroponically grown, transiently-transfected plants, (typically Nicotiana benthamiana, a relative of the tobacco plant), novel expression vectors, a large-scale transient transfection method, and other technologies that can be used to produce complex therapeutic proteins emerging from our own, our clients’ and our potential clients’ pipelines.  The Company believes the FastPharming System enables biologics production that is potentially faster, more cost-effective and more environmentally friendly than other approaches.

The Company operates in two categories: (i) Biopharmaceuticals: its biologics development and licensing segment which is focused on drug development in two primary areas: Therapeutics (currently Fibrosis and Oncology) and Vaccines (for humans and animals), and (ii) Bioprocessing: focused on two business lines: Services and Research & Bioprocess Products (“RBP”).

Biopharmaceuticals:

The Company is currently focused on developing candidates in the following disease areas:

Fibrotic Diseases

Fibrosis is a pathological disorder in which connective tissue replaces normal parenchymal tissue to the extent that it goes unchecked, leading to considerable tissue remodeling and the formation of permanent scar tissue. Fibrosis can occur in many tissues within the body, including the lungs (e.g., idiopathic pulmonary fibrosis (“IPF”) and skin (e.g., systemic scleroderma).  The Company’s endostatin E4 molecule, IBIO-100, is being evaluated for fibrotic diseases.

Oncology

iBio’s oncology efforts seek to identify therapeutics to aid in the treatment of cancer. Although there are a large number of cancer treatments available, there are few cures, and significant unmet medical need still exists for most types of cancer for improved treatments. Cancer remains the second most frequent cause of death worldwide. New research in oncology, especially that related to means to boost or support the patient’s immune system, is leading to a number of new treatments and new research programs with the potential to further improve cancer therapies. The Company’s IL-2 sparing anti-CD25 antibody, IBIO-101, is being evaluated in the treatment of solid tumors.  Further, the Company’s endostatin E4 molecule, IBIO-100, is being evaluated in solid tumors.  In addition, the Company has four additional oncology drug candidates in early development.  The targets for these candidates have not been disclosed.

iBio’s Glycaneering Technology enables the development of afucosylated recombinant proteins. Greater antibody dependent cellular cytotoxicity (“ADCC”) is often associated with such afucosylated proteins.  Thus, iBio’s Glycaneering Services can be used by the Company or its clients to potentially develop more potent cancer therapies.

Infectious Disease

Human Health: SARS-CoV-2

Coronavirus disease 2019 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (“COVID”). It was first identified in December 2019 in Wuhan, Hubei, China, and has resulted in an ongoing pandemic. Common symptoms include fever, cough, fatigue, shortness of breath or breathing difficulties, and loss of smell and taste. Some people develop acute respiratory distress syndrome (ARDS), possibly precipitated by cytokine dysregulation, multi-organ failure, septic shock, and blood clots. The Company’s nucleocapsid, antigen-based, intramuscularly delivered vaccine candidate, IBIO-202. Following review of its investigational new drug (“IND”) submission to the U.S. Food and Drug Administration (“FDA”) in January, the Company is moving forward with IND-enabling challenge studies for IBIO-202.

Animal Health:  Classical Swine Fever

Classical swine fever (“CSF”) is a contagious, often fatal disease affecting both feral and domesticated pigs. Outbreaks in Europe, Asia, Africa, and South America have not only adversely impacted animal health and food security but have also had severe socioeconomic impacts on both the pig industry worldwide and small-scale pig farming. Currently available vaccines can be efficient at triggering rapid animal immune response and protecting swine populations when combined with culling of infected pigs, but do not allow the differentiation of infected from vaccinated animals (“DIVA”), nor are they approved for use in the United States. The development of fully approved, DIVA-compatible, and efficacious vaccines represents an opportunity to prevent the economic impacts of a CSF outbreak including supply disruptions, export restrictions and reduced food security. The Company’s E2 protein subunit candidate, IBIO-400, is being evaluated as a vaccine to prevent CSF.

iBio’s current portfolio of products consists of the following:

Bioprocessing:

Services

iBio utilizes its FastPharming and Glycaneering intellectual property, Bioanalytics and process development capabilities, and cGMP manufacturing facility to provide development and manufacturing services on a contract basis.  

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Research & Bioprocess Products

iBio is developing proteins for use in cutting-edge research and cGMP manufacturing where the demand for high-quality products continues to evolve. The Company offers recombinant proteins for third parties on a catalog and custom basis. These catalog products can lead to opportunities to provide CDMO services or identify in-licensing opportunities for our proprietary biotech pipeline.