iBio, Inc. Q2 FY2021 earnings call

• Tom Isett expressed gratitude to the team and investors, highlighting iBio's transformation since late 2019, combining Glycaneering technologies with the FastPharming System, adding new team members, and introducing a new business model. - John Delta reviewed Q2 2021 financial results, noting revenue growth, higher operating expenses, and plans to provide more visibility on R&D, G&A, and cost of goods sold (COGS) in Q3. - New leaders joined the organization, including Robert Lutz as Chief Financial and Business Officer, Randy Maddux as Chief Operating Officer, Lisa Middlebrook as Chief Human Resources Officer, and Martin Brenner as Chief Scientific Officer. - Progress on the biopharmaceutical pipeline: Completed end-of-life phase of IND enabling toxicology studies for COVID-19 vaccine candidate IBIO-201; planning to submit an outline of production for classical swine fever vaccine IBIO-400; a patent was issued for Endostatin peptides for treating fibrosis; continued progress with CDMO agreements with ATB Therapeutics and Safi Biosolutions.

For the three months ended December 31, 2020, iBio reported revenue of $700,000, an increase from $300,000 in the same quarter the previous year. Total operating expenses were $8.3 million, compared to $3.5 million in the prior year. Research and development (R&D) expenses were $2.4 million (up from $900,000) and general and administrative (G&A) expenses were $5.8 million (up from $2.6 million). Net loss attributable to iBio stockholders was $8.2 million, or $0.04 per share, compared to a net loss of $25.4 million or $0.69 per share in the prior year. Cash and cash equivalents plus investments in debt securities were $107.6 million as of December 31, 2020.

• In Q3, iBio will begin reporting on revenues and expenses associated with new profit centers (therapeutics, vaccines, research and bioprocess products). - Expect R&D expense to grow and outpace G&A expense moving forward. - Anticipate moving forward with the second-generation COVID-19 vaccine candidate if toxicology data is positive.

• Risk of not obtaining regulatory approvals for product candidates. - Risk of not complying with ongoing regulatory requirements. - Regulatory limitations on promoting or commercializing product candidates. - Acceptance of product candidates in the marketplace. - Difficulty in maintaining license agreements, establishing and maintaining collaborations, and obtaining capital/grants. - Competition and ability to retain key employees. - Impact of the global pandemic on regulatory processes and timelines.

Q: How does iBio-100 differentiate from competing therapies in idiopathic pulmonary fibrosis (IPF)?

A: iBio-100 has a distinct mechanism of action. It showed good results in preclinical models, including reversal in fibrosis models, and is expected to have a better safety/tolerability profile compared to some existing therapies like pirfenidone.

Q: How does FastPharming enable greater production and cost savings in COVID-19 vaccines?

A: FastPharming offers speed, scalability, and can address cold chain requirements and new mutations. Subunit vaccines like IBIO-201 have advantages in cost and access compared to mRNA vaccines that have significant cold chain needs.

Q: What is the timeline for USDA approval of IBIO-400?

A: It could take up to two years depending on factors such as the global pandemic. Steps include submitting an outline of production, conducting efficacy and safety studies, and dealing with regulatory impacts of COVID-19.

Q: What is the status of the virus-like particle (VLP) platform for COVID-19 vaccines?

A: The VLP platform still has promise but is being advanced as a secondary platform while focusing efforts on IBIO-201 for COVID-19 vaccine development. Efforts are underway to enhance the VLP platform for future use.

Q: What are iBio's plans for investor relations and building shareholder value?

A: iBio is committed to continuous improvement in all facets, including investor relations. It plans to keep telling the company's story through website updates, pipeline advancements, and novel deals to build shareholder value.