Quarterly report pursuant to Section 13 or 15(d)

Nature of Business

v3.22.0.1
Nature of Business
6 Months Ended
Dec. 31, 2021
Nature of Business [Abstract]  
Nature of Business

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 Services TM 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 iBio’s proprietary approach to plant-made pharmaceutical and 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.  We believe the FastPharming System enables biologics production that is faster, more cost-effective and more environmentally friendly than other approaches.

The Company operates in two segments: (i) Biopharmaceuticals: its biologics development and licensing segment which is focused on drug development in two primary areas: Therapeutics (currently Fibrotics and Oncology) and Vaccines (human and animal health vaccines), and (ii) Bioprocessing: focused on two business lines: Services and Research & Bioprocess Products (“RBP”).

Biopharmaceuticals:

iBio’s Biopharmaceutical segment currently focuses on developing products using the FastPharming System in the follow areas:

Therapeutics

Anti-Fibrotics

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).

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, significant unmet need exists in many types of cancer for improved treatments. Cancer remains the second most frequent cause of death worldwide. New research on cancers, especially on how to boost or support the immune system to treat cancer, is leading to a number of new treatments and new research programs with the potential to further improve cancer therapies.

iBio’s Glycaneering Services provides iBio an opportunity to develop cancer treatments with enhanced potency.

Vaccines

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.

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 DIVA-compatible and efficacious vaccination solutions remains a top priority to prevent the economic impacts of a CSF outbreak including supply disruptions, export restrictions and reduced food security.

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

A screenshot of a computer

Description automatically generated with medium confidence

Bioprocessing:

Services

iBio’s contract development and manufacturing services use iBio’s FastPharming and Glycaneering intellectual property and know how to develop or manufacture proteins for others per a contract or to provide bioprocess services.


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 often can lead to opportunities to provide CDMO services or identify in-licensing opportunities for our proprietary biotech pipeline.