On November 8, 2023, Rani Therapeutics Holdings Inc (RANI, Financial), a clinical-stage biotherapeutics company, announced its financial results for the third quarter ended September 30, 2023, alongside a corporate update. The company has taken strategic steps to prioritize its key programs and streamline operations, extending its cash runway into 2025.
Strategic Prioritization and Clinical Trials
Rani Therapeutics has made significant decisions to prioritize its RT-102 and RT-111 programs, and the development of the RaniPill HC, a high-capacity capsule for oral drug delivery. The company has initiated a Phase 1 clinical trial for RT-111, a RaniPill GO containing an ustekinumab biosimilar, with results expected in the first quarter of 2024. Additionally, a Phase 2 clinical trial for RT-102, targeting osteoporosis, is slated to begin by the end of 2023.
Financial Performance
The company reported cash, cash equivalents, and marketable securities totaling $60.5 million as of September 30, 2023, a decrease from $98.5 million at the end of 2022. Research and development expenses increased to $11.2 million for Q3 2023, up from $9.1 million in the same period last year, primarily due to heightened pre-clinical and clinical development activities. General and administrative expenses decreased slightly to $6.6 million from $7.2 million year-over-year. The net loss for the quarter was $18.3 million, compared to a net loss of $16.2 million for the same period in 2022.
Preclinical Studies and Milestones
Rani Therapeutics has completed preclinical studies with the RaniPill HC, achieving a 100% oral delivery success rate in two antibody studies. The company aims to have the RaniPill HC ready for Phase 1 clinical trials in the second half of 2024. Near-term milestones include the initiation of the RT-102 Phase 2 clinical trial and the expected topline results from the RT-111 Phase 1 clinical trial.
Operational Streamlining
In line with its strategic focus, Rani Therapeutics has announced plans to expand manufacturing capabilities and reduce its workforce by approximately 25%. These measures are expected to align with the company's near-term goals and support its operating plans into 2025.
Rani Therapeutics continues to advance its pipeline and RaniPill platform technology, including the RaniPill HC, which has the potential to deliver a significantly higher drug payload than the company's existing oral biologics capsule. The company's focus on innovation and strategic program prioritization is designed to create long-term value for shareholders and enhance the potential of its technology platform.
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Explore the complete 8-K earnings release (here) from Rani Therapeutics Holdings Inc for further details.
