iBio, Inc. Q3 FY2022 earnings call

• Advancement of IBIO-202: Received FDA's response to the pre-IND package for IBIO-202, planning to file an IND for the intramuscularly delivered version by year-end.
• IBIO-101 progress: Completed lead optimization stage, with IND-enabling studies underway. Presented favorable preclinical efficacy data on IBIO-101 at the Frontiers in Immunotherapy Conference.
• FastPharming development: Plant-made monoclonal antibodies are comparable to those from traditional mammalian methods, with some having greater homogeneity. Glycaneering technology used to produce afucosylated monoclonal antibodies for increased potency, including for IBIO-101.
• Financials and special meeting: Revenues up, R&D and G&A expenses increased. Announced a special meeting of stockholders to seek approval for a reverse stock split and related authorized share changes.

For the third fiscal quarter ended March 31st, 2022, revenues were approximately $1.9 million, an increase of 154% versus the third quarter of fiscal 2021. In the quarter, $1.8 million in royalty revenue was recognized from the technology license with Fraunhofer. At quarter end, iBio had cash and cash equivalents plus debt securities of approximately $48.6 million, excluding $5.9 million of restricted cash. Revenue contribution from the Fraunhofer license was significant, making up a major portion of the quarter's revenue.

• Plan to file an IND for IBIO-202 by the end of the calendar year.
• IND-enabling studies for IBIO-101 are underway.
• Anticipate continuing investments in the pipeline but expect the rate of growth to moderate over time.

• Supply chain constraints: Impact on manufacturing timelines for biopharmaceutical programs.
• Regulatory uncertainties: Uncertainties in drug approvals and the IND process.
• Shareholder voting challenges: Difficulty in securing affirmative votes for proposals like reverse stock split due to brokerage firms' voting practices affecting retail shareholders.

Q: Follow up on afucosylation and partnering for technology.

A: Tom Isett discusses partnering opportunities for Glycaneering technology, including helping smaller biotechs and potential partnerships for IBIO-101.

Q: Timeline for USDA approval of IBIO-400 facility.

A: Tom Isett mentions delays due to regulatory process changes and that it could take upwards of a year after regulatory clearance on the facility.

Q: Reason for reverse stock split.

A: Tom Isett mentions reasons such as investment firm perception issues and stock price below $5 affecting certain investment practices