Rani Therapeutics reported a wider third-quarter loss as research and development spending increased, while collaboration revenue from Chugai provided $1.7 million. The clinical-stage company also said its oral-delivery platform has been accepted into an FDA program for early engagement and that enrollment is continuing in an expanded Phase 1a study of RT-114.
Rani ended September with $45.3 million in cash, cash equivalents and marketable securities. Based on its current operating plan, the company expects that funding to last at least through the end of 2027.
Key details
- FDA engagement for RaniPill: The platform was accepted in October into the FDA’s Emerging Technology Program, which supports discussion of novel approaches to pharmaceutical design and manufacturing. Rani expects to engage with the agency on technical, manufacturing and regulatory considerations, including through pre-submission meetings and possible site visits.
- The program is not an approval: Acceptance does not approve RaniPill or any drug candidate, and it does not change the usual regulatory requirements. Rani says the engagement will be useful as it works to automate its manufacturing process ahead of broader clinical use.
- RT-114 study is enrolling: The Phase 1a expansion cohort is expected to add 15 healthy volunteers. RT-114 uses RaniPill to deliver PG-102, a GLP-1/GLP-2 dual agonist being developed by ProGen. The study is intended to further characterize how drug exposure from oral delivery compares with subcutaneous administration. Rani expects additional data by the end of 2026.
- Cash declined during the quarter: Cash, equivalents and marketable securities stood at $45.3 million on September 30, down from $53.4 million on June 30.
- Quarterly revenue came from collaboration work: Contract revenue was $1.7 million, compared with none in the third quarter of 2025. Rani attributed the increase primarily to its collaboration and license agreement with Chugai.
- Costs and loss increased: Research and development expenses rose to $6.0 million from $3.2 million a year earlier, mainly because of higher compensation costs. General and administrative expenses increased to $4.9 million from $4.0 million, largely reflecting higher third-party services costs.
- Net loss was $8.8 million, compared with $7.9 million in the prior-year quarter. Stock-based compensation was $2.2 million, versus $2.3 million a year earlier.
- Partnerships remain part of the company’s strategy: Rani also cited its partnerships with Chugai, ProGen and PegBio, spanning rare disease, immunology and obesity programs.
Plain-English implications
Rani is still spending more than it earns, with collaboration revenue covering only part of its quarterly expenses. Its stated runway through at least the end of 2027 is based on its current operating plan. The FDA program offers a channel for early technical and regulatory discussions, but it is not a product endorsement or a substitute for clinical and regulatory approvals.