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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 Holdings, Inc. (Nasdaq: RANI) has been recognized by Fast Company with the top honor in the Health category of the 2022 World Changing Ideas Awards for its RaniPill™ capsule. This innovative technology aims to replace painful injections for biologic drugs, facilitating oral delivery while maintaining high bioavailability. The capsule, which contains a dissolvable needle, is currently undergoing multiple clinical trials, with the company striving to be a leader in oral biologics across various therapeutic areas.
Rani Therapeutics Holdings (Nasdaq: RANI) announced that CEO Talat Imran will present at the 21st Annual Needham Virtual Healthcare Conference on April 14, 2022, at 12:45 p.m. PT / 3:45 p.m. ET. This event provides an opportunity for investors and interested parties to hear insights directly from Rani's leadership.
Participants can access the live audio webcast through Needham or the Investor Relations section of Rani's website. A replay will be available for 90 days after the event.
Rani Therapeutics has initiated a Phase 1 clinical trial of RT-102, an oral treatment for osteoporosis. The company launched the RaniPill™ High Capacity (HC), enhancing delivery capacity to over 20 mg. Financially, cash reserves rose to $117.5 million in 2021, supporting operations through 2023. R&D expenses surged to $26.5 million due to increased headcount and equity compensation. However, net losses also expanded to $53.1 million. The company anticipates topline Phase 1 data in 2H 2022 and plans further clinical trials.
Rani Therapeutics (Nasdaq: RANI) will announce its fourth quarter and full year 2021 financial results on March 29, 2022, after market close. A conference call to discuss these results will take place at 1:30 p.m. PT / 4:30 p.m. ET that same day. Rani Therapeutics focuses on the oral delivery of biologics, having developed the RaniPill™ capsule aimed at replacing subcutaneous injections. The company has conducted various preclinical and clinical studies to assess the safety and bioavailability of the RaniPill™ technology.
Rani Therapeutics (Nasdaq: RANI) announced the initiation of a Phase 1 study for RT-102, an oral formulation of the human parathyroid hormone analog PTH(1-34) aimed at treating osteoporosis. This study is critical as it utilizes the RaniPill™ capsule to deliver PTH orally, potentially improving patient adherence compared to daily self-injections. Conducted in Australia, the study will evaluate the pharmacokinetics, safety, and tolerability of RT-102 in healthy adult women. Rani aims to revolutionize the delivery of biologics with this innovative oral treatment.
Rani Therapeutics has announced the development of RaniPill™ HC, a high-capacity oral delivery device capable of delivering over 500% more biologic payload than its existing capsule. This device can potentially deliver up to 20mg of biologics, unlocking over 50 new drug opportunities. In preliminary financial results, the company estimates a net loss of $13-15 million for Q4 2021, up from $5.8 million in Q4 2020, and a full-year loss between $53-55 million, compared to $16.7 million in 2020. Cash reserves are approximately $117.5 million.
Rani Therapeutics has appointed Lisa Rometty to its Board of Directors, enhancing its leadership team. With over 25 years of experience in global commercialization and strategic partnerships within healthcare, Rometty aims to advance the RaniPill technology, which seeks to replace subcutaneous injections with oral biologics. CEO Talat Imran emphasized the significance of her expertise in product commercialization for the company’s future. Rani Therapeutics continues to focus on developing and commercializing its innovative RaniPill™ capsule technology, which has shown promise in preclinical and clinical studies.
Rani Therapeutics (Nasdaq: RANI) reported its Q3 2021 financial results, highlighting a net loss of $28.7 million compared to $2.9 million in Q3 2020. R&D expenses surged to $12.0 million, primarily due to increased headcount and equity-based compensation costs. General and administrative expenses soared to $15.8 million from $0.8 million in the prior year. Despite the losses, Rani possesses $129.7 million in cash, expected to sustain operations through at least the end of 2023. The completion of a GLP study for RT-102 and preparations for a Phase I study in 2022 are notable advancements.
Rani Therapeutics Holdings (Nasdaq: RANI) announced the appointment of Lyn Baranowski to its Board of Directors, effective November 12, 2021. Baranowski brings 18 years of experience in the biotechnology sector, having held key roles at Altavant Sciences, Melinta Therapeutics, and AstraZeneca. CEO Talat Imran emphasized her expertise in strategic partnerships and financial transactions, which will be pivotal as Rani progresses its oral biologics delivery technology, RaniPill. This innovation aims to transform patient care by replacing injections with oral alternatives.
Rani Therapeutics (NASDAQ: RANI) announced that CEO Talat Imran will participate in a fireside chat at the Stifel 2021 Virtual Healthcare Conference on November 17, 2021, at 7:00 a.m. PT / 10:00 a.m. ET. The event will focus on the company’s innovative oral delivery system for biologics, utilizing the proprietary RaniPill™ capsule. Interested parties can access the live audio webcast through the company's website. A replay will be available for 30 days.
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