iBio, Inc. Q4 FY2021 earnings call

• Announced acquisition of RTX-003 rights from RubrYc Therapeutics for oncology and strategic collaboration with RubrYc for antibody discovery platform. - Advanced COVID vaccine candidate iBio-202 with pre-IND package submitted to FDA. - FastPharming platform uses plants for bio-pharmaceutical production, offering speed, scalability, sustainability. - Progress in oncology pipeline with San Diego drug discovery team, partnership with FairJourney Biologics, and Glycaneering technology for optimizing glycosylation. - Fibrosis work on iBio-100 with orphan drug designation for systemic scleroderma. - Animal health initiative with classical swine fever vaccine candidate iBio-400.

iBio operates in two segments: Biopharmaceuticals and Bioprocess. Biopharmaceuticals includes therapeutics and vaccine businesses focusing on oncology, fibrosis, infectious diseases, etc. Bioprocess houses products and services units offering contract development and manufacturing services using the FastPharming platform. Revenue for fiscal year-end June 30, 2021, was $2.4 million, a 50% increase over fiscal 2020. The bioprocess business is expected to drive revenue growth in fiscal 2022, with significant quarter-to-quarter revenue variability typical for early-stage pharma service companies.

• Revenue expected to grow in fiscal 2022, with sequential decline in first half of fiscal 2022 followed by higher growth in second half. - R&D and G&A expenses expected to continue growing in fiscal 2022 but at a lower rate than fiscal 2021. - Cash position as of June 30, 2021, was $97 million, sufficient to fund operations through first calendar quarter of 2023; could change with more in-licensing.

• Uncertainties in drug development timelines and outcomes. - Regulatory risks associated with submitting and obtaining approvals for drug candidates. - Market risks related to competition and commercialization of products.

Q: Now that you have access to the RubrYc computational platform, do you believe that this technology will be most useful for development in the new oncology pipeline, or do you envision this being broadly applicable throughout iBio's pipeline?

A: Rick, great question. The initial focus really will be on oncology. That's where we see a lot of opportunities. The whole category of Immuno-oncology. because you know it's a really attractive space. And when we pair up this capability, the targeting capability that the RubrYc discovery engine brings, along with the antibody libraries that we have access to, and then our Glycaneering technology where we can control the glycosylation patterns well, our monoclonal antibodies, there's a tremendous amount of value there. I'll ask Martin to comment on this a little bit further here in a minute, but also, two in the field of Immuno-oncology, there are a lot of combination therapies wherein you got a monoclonal antibody that can be paired with a checkpoint inhibitor to really drive some favorable any tumor responses. And so for those reasons, we see the most value coming from the oncology side of the portfolio. That said, there are other epitopes targeting benefits in other areas of the portfolio that we won't turn a blind eye to. But, Martin, would you like to comment a little further? Martin Brenner: Absolutely. So as Tom mentioned already, it is absolutely our priority to drive the RubrYc discovery platform and collaborate with RubrYc on immuno-oncology targets. As you know, there are several epitopes -- several targets that have hard-to-target epitopes. And those would be initial high-priorities for us. And as Tom also mentioned, this is applicable to other target classes, not just your traditional Immuno-oncology targets, which we will definitely explore going down the road.

Q: Could you please discuss a little bit about the discontinued ACE to EPCI project and whether there were any significant learnings to come out of the program despite the discontinuation?

A: Sure. The molecule we were able to bring that into our portfolio at an interesting time. And this is a little bit similar to what we're doing, but in a very different way with anti-CD-25, where you get another player in the space and a pre-look at how their clinical trials were going. When we brought that molecule in, there was the opportunity to pursue a certain pathway with it and we work closely watching appear on biologics who also had an ACE-2, FC in the clinic. And following their Phase 2 readout and our review of the regulatory landscape, as well as the clinical trial pathway that FDA had commented on, we simply felt that the opportunity for that particular strategy as a treatment for COVID-19 disease was risky at best. And the two companies in addition to [Indiscernible], I believe also Sorento and others had Ace-2FC molecules that were in their portfolios. and similarly discontinued those offerings and ultimately the cost-benefit of continuing with the molecule we deemed to not be worth it. That said, others may still continue to go forward. We returned the asset back to its originator and it's quite possible that someone else may choose to move forward with it. If that were to be the case, we still have the manufacturing capability. We've been able to produce the molecule on our platform. So we'd be available as a contract manufacturer if somebody else was to pick up the asset. But Martin did I miss anything there? Martin Brenner: No, Tom, I think you've covered everything, specifically the APR on data, that did not meet every -- all of the primary endpoints was disappointing to see.

Q: My question has to do with the San Diego facility, specifically wondering if you could authorize any detail with regard to the budget for that facility, and kind of most importantly, is the expense factored into your declared cash burn?

A: Yes, it is, Matthew, and in terms of the spending that we're associating with it, it's not only going to be the lease for the facility, of course but then also, the staff that we're hiring in that location. In terms of the capability that we're getting, we get -- we get a nice bang for the buck, especially with the synergy associated with what we have in for RubrYc. In fact, in our cash burn estimates, we had previously also factored in the potential for the collaboration with RubrYc and the in-license of the molecule. So that's all fairly well-baked in. Rob, anything I missed? Robert Lutz: No, that's correct, Tom.