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| Statement |
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| As I said, we've made good progress |
| Considering the obesity market is expected to exceed $100 billion by 2030, we are highly enthusiastic about the potential for our RaniPill to make an impact in this therapeutic area |
| Overall, we are very pleased with the data that our RaniPill delivered ustekinumab biosimilar antibody in healthy volunteers without any serious adverse events and with high bioavailability |
| So I think there's a really good fit in this market for a RaniPill that can take an injectable dose and get injectable efficacy with dosing schedules, as I said, that you can't do with a small molecule approach with an oral |
| I'm delighted to share the highlights of Rani Therapeutics' strong performance in 2023 during which the company achieved numerous milestones in the development of its pipeline programs and high capacity oral delivery device |
| We were very excited by those results as RT-111 achieved high bioavailability in humans |
| Overall, we are pleased with the progress we have made to date with our high capacity pill as we believe this will be at the forefront of our clinical development programs moving forward |
| I will now begin the call by highlighting one of our biggest achievements over the past year, and that is our positive Phase 1 results for RT-111, an orally administered ustekinumab biosimilar |
| So bringing a TNF-α oral in, perhaps a once a week pill is something that we're thinking about in that space would be a really exciting product, I think |
| Overall, I am exceptionally pleased by the results of our RT-111 study that Arvinder reviewed earlier |
| We believe these results provide validation that our platform can transform injectable large molecules into convenient oral pills |
| We do need to automate, and we've made incredible strides over the last year |
| And I think what's exciting about Rani's technology is that it's, from our perspective, future proof, whether it's muscle preservation drugs or combinations thereof |
| Newer oral therapies have the potential to improve outcomes |
| We have sufficiently managed our operating costs and even with the challenge of limited capital during 2023, we successfully completed the Phase 1 clinical study for RT-111 and significantly advanced development of the RaniPill HC, which is expected to be ready for clinical studies in the second half of this year |
| Last month, we announced positive results of the completed Phase 1 trial for RT-111 |
| We're shooting for, with RT-111 as an example, getting better near term efficacy, faster PASI scores, and then potentially even elevating in the maintenance phase as Arvinder referenced the efficacy, we think there's some potential there |
| In addition, it was well tolerated with no serious adverse events |
| In terms of efficacy, the drugs work really well |
| We feel like, based on the literature, that there's a potential to improve the tolerability of an incretin based therapy |
| In closing, we are proud to have built a world class leadership team at Rani and I would like to thank everyone at the company for their efforts this past year and so far in 2024 |
| Last fall, Rani announced successful oral delivery of Humira via the RaniPill HC in a preclinical study |
| The RaniPill platform has the potential to combine the efficacy, specificity and long half-life of a monoclonal antibody with the convenience and dosing flexibility of a pill |
| We are highly encouraged by this data and this is now our third successfully completed Phase 1 trial using our RaniPill technology |
| Ultimately, though, most patients will transition to maintenance dosing and after review, we believe there is a potential to improve on STELARA here as well |
| Rani intends to identify additional opportunities where there is a potential to create better products in terms of efficacy, safety and/or dosing schedule as compared to the originator |
| In addition, we are proud to announce that we have now dosed the RaniPill over 230 times in human subjects in three clinical studies without observing any serious adverse events related to the platform |
| The RaniPill HC successfully delivered adalimumab in all subjects |
| Humira remains a very popular drug amongst clinicians and patients and despite the biosimilars coming into the market, there's just not a lot of differentiation there |
| With RT-111 we aim to have a product that is highly differentiated as compared to other oral and injectable options currently being commercialized or in development |
| Statement |
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| I think that what some companies are doing to make oral therapies, while they generate great data, they have to increase the dose by 200x compared to an injectable and there's a COGS issue with that |
| I apologize |
| What do you think about the environment for more biosimilars to come? It started off pretty slowly about a decade ago, especially in the U.S |
| Additionally, no participants reported difficulty swallowing the RaniPill and capsule remnants passed from all participants |
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