Rani Therapeutics Holdings, Inc.

What they do

Rani is developing a drug-agnostic oral delivery platform, the RaniPill capsule, designed to deliver antibodies, proteins, peptides and oligonucleotides orally as an alternative to injections. It has two configurations: RaniPill GO, designed for doses up to 3 mg in microtablet form and tested in three completed Phase 1 trials, and RaniPill HC, designed for liquid payloads up to 200 L. The company is also pursuing partnerships with third-party biopharmaceutical companies to apply the platform to their biologics. It has no products approved for sale and has not generated revenue from commercial product sales.

Revenue drivers

• Collaboration and license agreements — Rani's reported revenue comes from partnership payments rather than product sales; the Chugai collaboration signed in October 2025 included a $10.0 million upfront payment plus up to $18.0 million in technology transfer milestones, up to $57.0 million in development milestones and up to $100.0 million in sales-based milestones.
• RaniPill GO — A capsule configuration designed to deliver up to a 3 mg drug dose in microtablet form with high bioavailability; three Phase 1 clinical trials have been completed, but it has no approved product or associated revenue.
• RaniPill HC — A high-capacity capsule intended to deliver liquid drug payloads up to 200 L; tested preclinically with antibodies and peptides and in a Phase 1 trial with RT-114 initiated in December 2025, with no product revenue.
• Obesity and metabolic pipeline — Rani is expanding its obesity franchise, including RT-114 (RaniPill HC delivering PG-102, a GLP-1/GLP-2 dual agonist) and a July 2026 research and development collaboration with PegBio to explore oral delivery of PegBio's obesity and metabolic candidates.

Recent performance

For the second quarter ended June 30, 2026, Rani reported revenue of $1.7 million, equal to the $1.7 million reported for the quarter ended March 31, 2026, after $1.5 million in the quarter ended December 31, 2025. Annual revenue was $1.6 million in 2025 and $1.0 million in 2024, with no revenue in 2022 and 2023, while net losses were $29.7 million in 2025 and $30.0 million in 2024. Operating cash use fell to $18.7 million in 2025 from $35.5 million in 2024. At June 30, 2026, total assets were $60.8 million, total liabilities $12.9 million, shareholder equity $39.2 million, and cash and equivalents $4.9 million. In July 2026, Rani reported positive initial Phase 1a data for RT-114 showing oral bioavailability greater than 150% relative to matched subcutaneous dosing, with no serious adverse events reported.

Strategy

Rani is advancing the RaniPill platform through clinical development while pursuing partnerships for oral delivery of third-party biologics. It initiated a Phase 1 trial of RT-114 in December 2025, expanded the Phase 1a study with fifteen additional healthy volunteers, and is working toward a Phase 1b repeat-dose study in patients with obesity by the end of 2026. It added a research and development collaboration with PegBio in July 2026 and entered a collaboration and license agreement with Chugai in October 2025 for a hemophilia antibody. The company raised $20.0 million in a May 2026 registered direct offering and is investing in automated manufacturing lines for the RaniPill capsule, with certain projects capitalized and others expensed based on alternative future use.

Risks

• No product revenue or approved products — Rani has no products approved for sale and has not generated commercial product revenue, so its reported revenue depends on collaboration payments and milestone receipts.
• Recurring operating losses and cash use — Rani reported a net loss of approximately $41.0 million for the year ended December 31, 2025, has incurred operating losses since inception, and expects significant losses for the foreseeable future.
• Early clinical development and single-source supply dependence — The company is in early clinical development with a limited number of candidates, has not completed pivotal trials or commercial-scale manufacturing, and relies on third-party suppliers, including single-source suppliers for certain components and materials.
• Low cash balance relative to spending — Cash and equivalents were $4.9 million at June 30, 2026, against a 2025 operating cash outflow of $18.7 million, though the company completed a $20.0 million registered direct offering in May 2026.

Outlook

Management expects additional data from the RT-114 Phase 1a dose expansion cohort by the end of 2026 and plans to initiate a Phase 1b repeat-dose study in patients with obesity by the end of 2026, with data anticipated in 2027. The company also plans to continue advancing its obesity pipeline, including through the PegBio collaboration, and to pursue partnering of the RaniPill technology. Management stated that the clinical and corporate milestones, together with the $20.0 million registered direct offering completed in May 2026, position Rani to make further progress in developing the RaniPill.