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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, will present clinical and preclinical data on their oral delivery platform, the RaniPill® capsule, at Digestive Disease Week 2024. The data will focus on the oral delivery of an Ustekinumab biosimilar, showcasing high bioavailability in healthy human participants and canines. The presentations will take place virtually and in-person on May 18-21, 2024, in Washington, DC.
Rani Therapeutics reported positive topline results from a Phase 1 study for RT-111, an oral anti-Interleukin 12/23 antibody, and plans to initiate a Phase 2 clinical trial for RT-102 for osteoporosis treatment in 2024. The company's RaniPill HC is set for potential Phase 1 trials later in 2024. Financially, Rani Therapeutics had $39.6 million in cash, cash equivalents, and marketable securities as of March 31, 2024, with a decrease in research and development expenses compared to the previous year.
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