Rani Therapeutics Holdings, Inc.

Hello, and welcome to Roni Therapeutics' fourth quarter and four-year 2022 financial results and corporate update conference call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ensure that we have ample time to address everyone's questions during the Q&A session, we will ask for a limit of one question and one follow-up question per person. As a reminder, this call has been recorded today, Wednesday, March the 22nd, 2023. I would now like to turn the conference over to Lawrence Watts of Gil Martin Group. Please go ahead, sir.

Thank you, operator. Joining us on the call today from Rani Therapeutics are Chief Executive Officer, Talat Imran, Chief Financial Officer, Spike Sanford, and Chief Scientific Officer, Amir Hashim. During this conference call, management will make forward-looking statements that are subject to risks, uncertainties, and assumptions, such as, but not limited to, those discussed in the risk factors section of the company's filings with the Securities and Exchange Commission, including its annual report on Form 10-K and quarterly reports on Form 10-Q, which identify the specific factors that may cause actual events or results to differ materially from those described in these forward-looking statements. These statements may include, without limitation, statements regarding product development and clinical trials, product potential, device progress and performance, potential impact on patients, the regulatory environment, manufacturing progress, certain business strategies, capital resources, or operating performance. Actual results and the timing of events could differ materially from those projected in such forward-looking statements. With that, I will turn the call over to Talat Imran, Chief Executive Officer of RANI. Talat?

Thank you, Lawrence. Good afternoon, everyone, and thank you for joining our fourth quarter and full year 2022 financial results conference call. I'm delighted to share the highlights of Ronnie Therapeutics' strong performance in 2022, during which the company achieved numerous milestones in the progression of its pipeline program and improvements in device performance. I would like to start by reviewing the important milestones that Ronnie achieved throughout the year. Last year, We made significant enhancements to the Ronnie Pill platform, highlighted by the unveiling of our high-capacity Ronnie Pill 8C device, and continued improvement in both the manufacture and performance of our Ronnie Pill Go device. In February of 2022, Ronnie announced the development of the Ronnie Pill 8C, capable of administering 500% plus higher payloads than our standard Ronnie Pill Go. While the RoniPill Go is designed to deliver drugs with a daily dose of up to three milligrams, the RoniPill 8C can potentially deliver up to 20 milligrams per pill. We are currently in preclinical studies with the RoniPill 8C. Importantly, with this new device, we now have the potential to target a much larger market of molecules, such as pembrolizumab, etanercept, trastuzumab, and cecoquinumab. Concurrent with the development of the RoniPill 8C, We have continued to make improvements in the development of the Ronnie Pill Go, which is being utilized across our current internal development pipeline. We have progressed our manufacturing scale-up and automation efforts, and I'm happy to report that we are now capable of supporting a phase two program in the second half of this year with our current manufacturing line. We also plan to support three additional phase one clinical studies of other pipeline programs concurrently in 2023. In addition, Subtle but important improvements in our manufacturing processes resulted in our latest iteration of the Ronnie Pill Go achieving a 92% drug delivery success rate in our recently completed phase one study of RT-102. Beyond the improvement in device performance, the phase one study of RT-102 met all of its endpoints. RT-102 delivered PTH with 300 to 400% higher bioavailability for 20 micrograms and 80 micrograms of PTH respectively when compared to 20 micrograms of Porteo delivered via subcutaneous injection. In addition, RT102 was well tolerated and no serious adverse events were reported in the study. Of the few minor adverse events reported, all were deemed mild to moderate and resolved on their own. The phase one study results add to our robust and growing body of data supporting the safety and performance of the Ronnie pill. We are very pleased with the favorable safety profile demonstrated by the Ronnie pill capsule to date. We have now dosed nearly 100 human subjects in clinical studies with no serious adverse events to report. As we plan for the initiation of our first phase two clinical trial in the second half of 2023, I would like to remind everyone about our recent interactions with the FDA particularly the feedback received during our pre-IND meeting for RT-102. Based on guidance from the FDA, we believe that the 505 pathway is suitable for RT-102, our PTH analog program. We appreciate the interactions we have had to date with regulators and will continue to take their input into account as we progress our development programs. Turning to the development of RT-111, We were pleased to recently announce our partnership with Celtrion. Under this partnership, Celtrion will exclusively supply to Ronnie the Usakinumab biosimilar drug substance, CTP43, required for RT-111. Ronnie has been granted an exclusive license to use CTP43 in the development and commercialization of RT-111. And Celtrion, in turn, has been granted a right of first negotiation to acquire worldwide rights to RT-111 following a phase one clinical trial. We believe our partnership with Celtrion, a leader in biosimilars and biologics manufacturing, validates the strength of our Ronnie Pill oral drug delivery platform. We are delighted to be working with Celtrion and look forward to potentially broadening our partnership over time. Lastly, before I turn it over to Mir Hashim to cover our preclinical and clinical data in more detail, I would like to remind you of our anticipated near-term milestones, which include initiating a phase two clinical trial with RT-102 in the second half of 2023, and initiating three additional phase one studies with pipeline molecules, RT-105 containing an adalimumab biosimilar, RT-110 containing PTH for hyperparathyroidism, and RT-111 containing celtrion's ustekinumab biosimilar. With that, Let me now turn the call over to Mir Hashim to discuss our preclinical and clinical updates in more detail. Mir?