Rani Therapeutics Holdings, Inc. Class A Common Stock H.C. Wainwright 28th Annual Global Investment Conference

Brandon, thank you for having us, and thank you to H.C. Wainwright as well for giving us this opportunity.

Absolutely. Rani Therapeutics is a clinical stage biotech, and we've developed a platform technology for the oral administration of virtually any biologic. Are you guys hearing that boom as well? Is that No. Okay. Any biologic with bioavailability that's comparable to a subcutaneous injection.

This is a really big claim. It's been called the Holy Grail of drug delivery before. Prior to us, the best performing technologies like SNAC, which is used in oral semaglutide, can deliver bioavailability sub 1%, and that only for small peptides. We can deliver monoclonal antibodies, large proteins, and we do this with what we call the RaniPill. It looks like a pill, but it is essentially a swallowable auto-injector. It's a mechanical device that survives the acidic environment of the stomach, gets to the small intestines. There's a self-inflating balloon in it that opens up, aligns, and then delivers an injection pain-free through the gut wall. There are no sharp pain receptors in the gut, so this is a pain-free injection.

The drug is delivered, and it's because of this, it's essentially a sub-Q injection by other means. You can think of it that way. We can deliver HUMIRA, dupilumab. It doesn't matter what you put into the RaniPill. And in every case, in our preclinical studies, we've shown equivalent to superior bioavailability.

I guess in a word I would use to describe it is validation. What we are doing is incredibly novel. When people see it the first time, we hear science fiction quite a bit, right? Maybe Brandon, when you saw it for the first time as well. Even in describing it, a self-inflating balloon and an automated injector, a robotic pill, however you put it. They did two years of diligence on us. They tested two of their molecules in the RaniPill, came on site, looked at our manufacturing and automation, looked at our quality processes, and got comfortable enough because focus initially was on a rare disease target, which is what the license portion of the license and option agreement is for with Chugai and Roche. After looking at what we do, they added five option agreements for another $900 million in potential payments to the company.

Those cover broadly high-value immunology targets. I think that helped catalyze the concurrent PIPE that we did with H.C. Wainwright last year, a $60 million PIPE that brought in Samsara and RA Capital and some other investors. I think that has been the critical value inflection driver for us. Obviously, we have generated a ton of data pre-clinically and clinically before. But in combination now with validation from a big pharma company, it set up, I think, the next chapter of the company.

There's not a ton I can say on that because it's their programs, but there are development milestones pertaining to manufacturing miles development that we have to do for our aseptic manufacturing process and for our assembly of the device. Beyond that, they will take the program into the clinic, and there will be additional milestones that come out of that. We expect probably at least one milestone to hit next year.