iBio, Inc. Q2 FY2022 earnings call

Tom Isett's Remarks

• Productive quarter with advancement in immunooncology pipeline and second-generation COVID-19 vaccine. Received FDA feedback on IBIO-202, moving to IND-enabling studies and plan to file IND by end of year. Discussed DAVi strategy for COVID vaccine focusing on durability, access, and variant inclusion.
• Added six new immunooncology assets to pipeline in six months, with a monoclonal antibody designed with machine learning progressing quickly. Partnership with RubrYc on IL-2 sparing anti-CD25 antibody and research collaboration with UTSW on endostatin E4 molecule.

Martin Brenner's Remarks

• Drug discovery programs classified into four stages: early discovery, late discovery, lead optimization, IND-enabling. Highlighted RubrYc collaboration, reducing early discovery phase time from 6-8 months to 3 months using machine learning and Meso-scale Engineered Molecules (MEMs).

Rob Lutz's Remarks

• Revenues decreased 76% vs fiscal 2021. R&D and G&A expenses increased. In November, used $6 million in cash and took on debt to purchase manufacturing facility and acquire CDMO subsidiary. Liquidity: $57.4 million in cash, marketable securities, etc. as of Dec 31, 2021, with cash runway extended to Sep 30, 2023.

Revenues for the second fiscal quarter of 2022 ended December 31 were approximately $200,000, a decrease of 76% versus the second quarter of fiscal 2021. R&D and G&A expenses for the second quarter of fiscal 2022 increased 40% and 48% respectively over the comparable period in fiscal 2021. These reflect the company’s growing investment in its pipeline, platform technologies, employees, and related infrastructure.

Revenue

• Expect revenue growth to return in second half of fiscal 2022.

Expenses

• R&D and G&A expenses expected to continue increasing but at a moderated rate.

Pipeline

• Focus on advancing oncology assets, moving IBIO-101 to IND-enabling studies, progressing IBIO-100 to lead optimization stage, and filing IND for IBIO-202 by end of calendar year.

• Uncertainties in biopharmaceutical development timelines and outcomes.
• Regulatory feedback and approval processes for vaccines and therapeutics.
• Quarter-to-quarter revenue variability due to customer contracts and revenue recognition timing.
• Competition in the biopharmaceutical space for vaccine and oncology therapies.

Q: Related to oncology, provide big picture on targets and precision medicine approaches.

A: Tom Isett discussed challenges with immunosuppressive regulatory T-cells and using antibody engineering, machine learning, and MEMs to address safety and efficacy. Martin Brenner mentioned utilizing well-validated targets with improved safety margins.

Q: Regarding IBIO-202, status of challenge study and T cells vs antibodies.

A: Martin Brenner stated they are in planning stage of challenge study, and there's accumulating evidence of N-mediated T-cell response being protective.

Q: Cash guidance and CDMO business ownership.

A: Rob Lutz mentioned assumptions are conservative, and the company maintains full ownership of the CDMO subsidiary.

Q: HHS/BARDA RFI for next-gen COVID vaccines and Fraunhofer settlement.

A: Tom Isett confirmed awareness of RFI and efforts to respond, while details of Fraunhofer settlement are in filings with some confidential elements but financial info available.

Q: Sales weakness and production plant use.

A: Tom Isett discussed transitioning to biotech business, validating FastPharming platform, pipeline growth, and potential partnerships to generate revenue over time with quarter-to-quarter revenue variability common in early-stage CDMO/biotech companies