Rani Therapeutics Holdings, Inc. (NASDAQ:RANI) Q4 2022 Earnings Call Transcript

As far as the RT-102 Phase 2 design is concerned, we did ask the FDA what they would want to see in terms of endpoints. And we’re going to be looking at biomarkers. So P1NP and CTX and the duration is likely going to be eight weeks. You can see separation on those biomarkers fairly rapidly. And then from there, we would start planning for a Phase 3 where we would likely be looking at BMD as the endpoint.

Annabel Samimy: Okay. Great. Thank you so much.

Talat Imran: Thank you, Annabel.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Ash Verma with UBS. Your line is open.

Ashwani Verma: Hi. Thanks for taking my questions. Congrats on the progress so far. I have two. So one was just, on the Phase 1 study that you’re planning right in 2023. So single dose study, these should be relatively quick, I would imagine like what kind of timeline do you think we can expect for the completion of these studies? And then second, anything that you can comment on kind of the cadence of OpEx given that you plan to initiate the Phase 2 for RT-102 in the second half year, how would OpEx compare in ’23 versus 2022? Thanks.

Talat Imran: Thank you, Ash. Appreciate the questions. You are correct. The timeline for these Phase 1s is relatively short. It’s a matter of months to get them done. I will say the RT-111 will take a bit longer than RT-102 single dose just because the half-life of that drug is significantly longer. So in order to get the full curve, you have to track the patients for a bit longer. But we’re also hoping and hope is not a plan, but with COVID not being as much of an issue as it was early last year that if recruitment is fairly straightforward, this is a healthy volunteer study that we should be able to enroll fairly quickly and that will help with getting it done quickly as well. And we all are incentivized to do so. With your second question, I’m going to turn that over to Svai Sanford, our CFO, to answer.

Svai Sanford: Thank you, Talat. Hopefully, everyone can hear me. Ash, thank you for the question. We ended, as you can see in our filing, we ended the 2022 with the non — with the cash portion of the OpEx just under $50 million. I expect that our operating expenses will increase for 2023 in the range of 20% to 30% from last year.

Ashwani Verma: Great. Thanks, guys.

Talat Imran: Thank you, Ash.

Operator: Thank you. Please stand by for our next question. Our next question comes from the line of Bert Hazlett with BTIG. Your line is open.

Bert Hazlett: Yes, thank you. Thank you for taking the question and congratulations on all the progress. Two topics in general. One is Celltrion. And as you think about the development of RT-111 CT-P43, is there a prioritization with regard to indication with the development of that program? Or how are you thinking about kind of steps beyond Phase 1? And then second question is kind of a similar question with regard to prioritization of the monoclonals that you mentioned whether that’s pembrolizumab, trastuzumab or others, how are you thinking about maybe prioritization of those types of molecules? Just general thoughts there would be helpful. Thank you.