Rani Therapeutics Holdings, Inc., a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, announced a strategic plan to prioritize key programs, expand manufacturing capabilities, and streamline business operations. These efforts are aimed at driving short-term value and ensuring long-term growth. The plan includes a focus on key development programs like RT-102, RT-111, and RaniPill® HC, along with expanding manufacturing capacity to support growth and forming strategic partnerships. Additionally, cost-saving measures will be implemented to align with Rani's near-term objectives. The anticipated savings are projected to sustain Rani's operational plans through 2025.
As a result of these initiatives, Rani anticipates extending its financial runway through 2025. The company will prioritize the RT-102, RT-111, and RaniPill® HC programs, and will expand its manufacturing space by approximately 33,000 square feet. Development of RT-101 will be discontinued, while RT-105 and RT-110 projects will be put on hold. Additionally, Rani will reduce its workforce by around 25%. The restructuring is expected to incur a one-time expense of approximately $0.3 million, primarily related to severance payments, with completion targeted by the end of Q1 2024. The majority of these costs are anticipated in Q4 2023.
Key Milestones in the Near Term Include:
- Initiation of Phase 2 study for RT-102, a RaniPill® GO containing teriparatide for osteoporosis, expected in Q4 2023.
- Topline results of Phase 1 study for RT-111, a RaniPill® GO containing ustekinumab biosimilar CT-P43, expected in Q1 2024.
- Preparation of RaniPill® HC for potential Phase 1 trials in H2 2024.
Regarding preliminary third-quarter financial results, Rani estimates cash, cash equivalents, and marketable securities to be approximately $60.5 million as of September 30, 2023. The projected net loss for Q3 2023 is estimated to be between $17.0 million and $19.0 million, compared to $16.2 million in Q3 2022. For the nine months ending September 30, 2023, the net loss is projected to be between $53.0 million and $55.0 million, compared to $46.0 million for the same period in 2022. These figures include estimated stock-based compensation expenses of approximately $5.0 million for Q3 2023 and approximately $14.5 million for the nine months ending September 30, 2023. This compares to $4.4 million for Q3 2022 and $11.3 million for the same period in 2022, respectively.