iBio, Inc. Q1 FY2021 earnings call

• Transitioned from a CDMO services-only model to include proprietary product development starting in December 2019, leveraging FastPharming and Glycaneering technologies.
• Responded to COVID-19 pandemic by creating SARS-CoV-2 VLP-based constructs, initiating vaccine candidates iBio-200 and iBio-101, and obtaining an exclusive license to ACE2-Fc.
• Resumed development of legacy biopharmaceutical programs: iBio-100 for anti-fibrotic diseases and iBio-400 for classical swine fever.
• Appointed new board members (Linda Armstrong, Alexandra Kroptova, Gary Sender) and management (Randy J. Maddux as COO).
• Entered agreement with Safi Biosolutions to supply recombinant proteins, with potential to build a portfolio of research and bioprocess proteins.
• Proceeding with legal action against Fraunhofer for intellectual property misuse, with a trial set for March 2021.

For the three months ended September 30, 2020, iBio reported revenue of $410,000, an increase of $302,000 from the same quarter last year. Revenue backlog was approximately $2.4 million as of September 30, 2020. Total operating expenses for the quarter were $7.3 million, with R&D expenses at $1.8 million and G&A expenses at $5.5 million. Net loss attributable to iBio stockholders was $7.5 million. As of September 30, 2020, iBio had cash and investment in securities of $83.5 million.

• Expect R&D expenses to begin outpacing G&A expenses moving forward.
• Plan to begin offering a new catalog of research and bioprocess proteins by mid-2021.
• Efficacy study for iBio-400 planned for June 2021, with a safety study later in 2021; progress on iBio-201's toxicology studies and IND filing dependent on FDA review.

• Uncertainty regarding regulatory approvals for product candidates, including COVID-19 vaccines.
• Compliance with ongoing regulatory requirements.
• Market acceptance of product candidates.
• Competition in the biotech and CDMO space.
• Ability to retain key employees.
• Potential impact of Fraunhofer litigation on intellectual property and business.

Q: Can you share how you rank opportunities in front of you, including COVID-19, fibrotic disorders, research and bioprocess proteins, etc.?

A: iBio-100 for fibrotic disorders, iBio-201 for COVID-19, research and bioprocess proteins, oncology via glycan engineering, and animal health are all significant opportunities.

Q: Update on Safi Biosolutions agreement and investment?

A: Safi is a young company using iBio's platform to accelerate their bioprocess, with iBio potentially becoming their contract manufacturer and building its own portfolio of proteins.

Q: Update on Fraunhofer litigation?

A: Hearing in June, proceeding to trial in March 2021, damages phase earlier, Fraunhofer was found to have used iBio's IP without permission.

Q: Timeline for iBio-400 clinical trials?

A: Efficacy study by June 2021, safety study later in 2021, involving a thousand swine.

Q: Relationship with IBM and Watson?

A: Waiting on regulatory reviews and IND enabling studies, then IBM Watson will support clinical trial management.

Q: Transparency for retail investors?

A: Commit to timely material information and frequent updates on programs.

Q: Reason for increasing share count?

A: To stabilize the company, fund biopharmaceutical development, and pursue opportunities like the Safi agreement.

Q: Lobbying activity and Medicago progress?

A: Engaged Steptoe and Johnson for government relations, encouraged by Medicago's progress with plant-based vaccines.

Q: Stock price fluctuations and transparency?

A: Committed to timely material information and building a strong company, with confidence in long-term success.

Q: Ownership of Bryan, Texas facility?

A: Roughly 70/30 split between iBio and Eastern Capital, with tracking stock conversion considerations.