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Rani Therapeutics Holdings, Inc. (Nasdaq: RANI) is a trailblazing clinical-stage biotherapeutics company focused on revolutionizing drug delivery through its proprietary platform technology. The company's main innovation, the RaniPill capsule, aims to transform the administration of biologics by making it possible to deliver these typically injectable drugs orally. This groundbreaking approach offers a convenient alternative to patients who frequently endure painful subcutaneous or intravenous injections.
The RaniPill technology has been designed to handle various drug substances, including antibodies, proteins, peptides, and oligonucleotides. Among its key advancements, Rani Therapeutics has introduced the RaniPill HC, a high-capacity capsule that can deliver drug payloads up to 200 microliters in liquid form with high bioavailability. This novel capsule has shown promising results in preclinical studies, demonstrating high reliability and the potential to mimic parenteral drug administration.
Rani Therapeutics has successfully conducted multiple preclinical and clinical trials to evaluate the safety, tolerability, and bioavailability of the RaniPill technology. Significant progress includes the development of two RaniPill capsules: RaniPill GO and RaniPill HC. These trials have validated the platform's ability to convert injectable biologics into oral formats, paving the way for further clinical advancements.
Recently, Rani Therapeutics reported its preliminary consolidated financial results for the third quarter ending September 30, 2023. The company is strategically prioritizing its RT-102 and RT-111 programs while advancing the RaniPill HC towards Phase 1 clinical readiness by the second half of 2024. The company expects to initiate the Phase 2 study of RT-102 in 2023 and aims to achieve key milestones that extend its operational cash runway into 2025.
Looking ahead, Rani Therapeutics continues to focus on expanding its manufacturing capabilities to support scaling and potential partnering opportunities. The company remains committed to its vision of making oral biologics a reality across various therapeutic indications, driving significant value for patients, healthcare providers, and shareholders.
Rani Therapeutics, a clinical-stage biotherapeutics company, announced that its CEO, Talat Imran, will participate in a fireside chat at the H.C. Wainwright BioConnect Investor Conference on May 2, 2023, at 11:30 AM ET. The event will showcase Rani's innovative approach to oral delivery of biologics and drugs, primarily through its patented RaniPill® capsule technology, which aims to replace traditional injection methods. Interested parties can access the live webcast from the Investor Relations section of Rani Therapeutics' website, with a replay available post-event.
Rani Therapeutics is dedicated to enhancing drug delivery systems and has successfully conducted multiple preclinical and clinical studies to validate the safety and efficacy of its oral dosing technologies.
Rani Therapeutics, a clinical-stage biotherapeutics company, announced that CEO Talat Imran will present at the 22nd Annual Needham Virtual Healthcare Conference on April 18, 2023, at 12:45 p.m. PT / 3:45 p.m. ET. The presentation will focus on Rani's innovative RaniPill capsule technology, designed to facilitate the oral delivery of biologics and drugs, potentially replacing subcutaneous and intravenous methods. Interested individuals can access the live webcast via Rani's Investor Relations page, with replays available for approximately 90 days post-event. Rani Therapeutics is committed to advancing oral drug delivery technologies and has successfully completed multiple studies to assess the safety and efficacy of its RaniPill platform.
Rani Therapeutics Holdings (RANI) announced significant advancements in its pipeline, including the anticipated initiation of its first Phase 2 study for RT-102 targeting osteoporosis in 2H 2023. The company reported positive topline results from a Phase 1 repeat-dose study of RT-102, achieving all endpoints. Moreover, initial feedback from the FDA suggests a suitable 505(b)(2) pathway for RT-102's development. A partnership with Celltrion has been established to advance the RT-111 program, an oral ustekinumab biosimilar. Financially, Rani reported a net loss of $63.3 million for 2022, an increase from $53.1 million in 2021, with cash reserves of $98.5 million expected to support operations through mid-2024.
Rani Therapeutics Holdings, Inc. (Nasdaq: RANI) will release its fourth quarter and full year financial results for 2022 on March 22, 2023, after the market closes. Following the announcement, management will host a conference call at 4:30 p.m. ET to discuss the results and take questions. Rani Therapeutics focuses on oral delivery technologies for biologics and has developed the RaniPill™ capsules aimed at replacing injections with oral dosing. The company has conducted various studies to assess the safety and bioavailability of its products, emphasizing its innovative approach to drug administration.
Rani Therapeutics has partnered with Celltrion to develop RT-111, an oral biosimilar of ustekinumab (CT-P43). As per the agreement, Celltrion will be the exclusive supplier of CT-P43 for Rani's RT-111 program. Rani holds exclusive rights to use CT-P43 in its development efforts. The RaniPill™ technology aims to facilitate oral administration of biologics, enhancing patient comfort. Rani’s CEO highlighted the validation of RaniPill's effectiveness in previous trials. The partnership positions Rani for potential commercial success following clinical trials.
Rani Therapeutics announced preliminary FDA feedback on RT-102, suggesting a 505(b)(2) development pathway could be suitable. The company presented updates on its clinical trials, including positive topline results from the Phase 1 study, achieving all endpoints and demonstrating good tolerability. The anticipated key milestones for 2023 include the initiation of the Phase 2 trial for RT-102 in osteoporosis and three additional Phase 1 studies. Rani's preliminary cash position stands at approximately $99 million as of December 31, 2022.
Rani Therapeutics announced positive topline results from Part 2 of its Phase 1 study for RT-102, an oral drug for osteoporosis. The study met all endpoints, with a 91% success rate in drug delivery via the RaniPill™ GO capsule, which was well tolerated by the participants, showing no serious adverse events. The data supports moving to a Phase 2 trial anticipated in H2 2023. Approximately 185 capsules have been administered in clinical studies, reinforcing the viability of the RaniPill™ platform for oral biologic delivery.
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