Rani Therapeutics (NASDAQ:RANI) executives highlighted what they described as a “transformational” 2025 during the company’s fourth-quarter and full-year earnings call, pointing to progress advancing its oral biologics delivery platform, the launch of a new clinical study, and a new strategic collaboration that helped bolster the balance sheet.
Chief Executive Officer Talat Imran said the clinical-stage company continues to develop its proprietary Rani Pill capsule, which is designed to enable oral delivery of biologics and other therapies as an alternative to subcutaneous injections or intravenous infusions while targeting comparable bioavailability. Imran said Rani has conducted multiple preclinical and clinical studies to evaluate safety, tolerability, and bioavailability of therapies delivered using the platform.
Chugai collaboration and financing
He added that the deal includes an option for Chugai to expand the collaboration to as many as five additional drug targets under similar terms, which management framed as evidence of the platform’s scalability and potential applicability across a range of biologic molecules and therapeutic areas, including rare disease and immunology.
Alongside the Chugai agreement, Rani completed an “oversubscribed” $60.3 million private placement in October 2025 that included $6 million of debt conversion, which management said strengthened the company’s capital position and extended its projected cash runway into the fourth quarter of 2027.
Pipeline updates: RT-114 enters the clinic
A key operational milestone for 2025 was the initiation of a phase I clinical trial for RT-114 in December 2025. RT-114 is Rani’s oral version of PG-102, a bispecific GLP-1/GLP-2 receptor agonist delivered via the Rani Pill capsule. Imran noted that PG-102 is an Fc fusion GLP-1/GLP-2 molecule being developed by ProGen.
Management previously reported preclinical data in March 2025 showing RT-114 achieved 111% relative bioavailability compared to subcutaneous PG-102, with comparable pharmacokinetic profiles. Imran also said the company observed comparable weight loss between oral RT-114 and injected PG-102 in those studies, with less variability in the RT-114 group.
The company also presented additional RT-114 data at ENDO 2025, which Imran said included canine data supporting bioequivalence and strengthening confidence in the program’s translational potential.
According to Imran, the newly initiated phase I study is designed to evaluate safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics across single and multiple doses. In the Q&A session, Imran clarified that the company is running a phase I-B component: an eight-week study in obese patients where weight loss is one of the endpoints. He said the company plans to compare weight loss results to historical data for PG-102.
Imran also discussed the role of tolerability in dose selection. While the company has debated whether better tolerability and oral convenience could support testing higher doses, he said Rani’s focus is on finding a profile that keeps patients on therapy long term, rather than “just maximizing weight loss” at the expense of nausea, vomiting, or other tolerability issues. He said the company would evaluate options after reviewing the phase I-B data.
RT-116 and platform validation efforts
Rani also highlighted preclinical work on RT-116, an oral semaglutide program delivered via the Rani Pill capsule. Imran said Rani reported preclinical data in February 2025 showing comparable bioavailability, pharmacokinetics, and weight loss versus subcutaneous semaglutide, and that RT-116 was well-tolerated with no serious adverse events observed.
In response to an analyst question about why RT-114’s clinical data could be important given prior results for PG-102’s active ingredient, Imran pointed to Rani’s historical clinical experience demonstrating high bioavailability across multiple programs including octreotide, teriparatide, and a secukinumab monoclonal antibody. He described RT-114 as the first Fc fusion protein the company has brought into the clinic and said the study could provide new learnings around pharmacokinetics.
Imran also characterized RT-114 as the company’s first pharmacodynamic (PD) study with the Rani Pill in humans. He said Rani has generated PD data in canines for several incretins, including RT-114/PG-102, showing comparable weight loss to subcutaneous delivery, and suggested that reproducing similar relationships between PK and weight loss in humans could support broader confidence in the platform as a delivery mechanism across other therapeutic areas.
When asked whether positive RT-114 PD data could influence future partnering discussions, including Chugai’s option decision-making, Imran said it could be a de-risking event depending on the partner but declined to comment on Chugai’s plans regarding its options, noting those decisions rest with the partner.
Financial results and cash runway
Chief Financial Officer Svai Sanford reviewed results for the quarter and year ended December 31, 2025, and pointed investors to the company’s press release and Form 10-K filed the same day.
- Cash position: Cash, cash equivalents, and marketable securities were $49.7 million as of December 31, 2025, compared with $27.6 million at the end of 2024. Sanford attributed the increase primarily to the October 2025 private placement and the upfront license payment from the Chugai agreement, which closed concurrently.
- Debt: Sanford said Rani repaid all outstanding debt due to Avenue Capital during the fourth quarter and had no outstanding debt obligations as of December 31, 2025.
- Runway: Based on the current operating plan, Sanford said the company believes existing cash, equivalents, and marketable securities—“including expected technology transfer milestone payment under the Chugai agreement”—will fund operations into the fourth quarter of 2027 without additional financing.
- Contract revenue: Contract revenue was $1.5 million for the fourth quarter and $1.6 million for full-year 2025. Sanford said $1.5 million related to the Chugai agreement and $0.1 million to evaluation services for a customer. He noted that while the Chugai agreement included a $10 million upfront payment, accounting guidance requires the amount to be recognized over time; as a result, $1.5 million was recognized in the fourth quarter.
- R&D expenses: Research and development expenses were $4.9 million for the fourth quarter and $20.2 million for 2025, down from $6.8 million and $26.7 million, respectively, in 2024. Sanford said the year-over-year decrease reflected cost containment measures including a temporary pause and termination of certain R&D programs and reduced compensation, while noting R&D expenses are expected to increase as select programs resume and the platform advances.
- G&A expenses: General and administrative expenses were $5.1 million for the fourth quarter and $19.7 million for the year, compared with $5.5 million and $23.9 million in 2024, with the decline driven primarily by cost containment and reduced employee compensation.
- Net loss: Net loss was $9.1 million for the fourth quarter and $41.0 million for the full year, compared with $15.7 million and $56.6 million, respectively, in 2024. Sanford said the 2025 results included non-cash stock-based compensation expense of $2.2 million in the quarter and $11.8 million for the year.
In closing remarks, Imran reiterated that management believes the Chugai collaboration supports the “broad applicability” of the Rani Pill platform and that obesity represents a near-term opportunity, while emphasizing the company’s focus on tolerability in a market where discontinuation rates can be high. He said Rani is “well capitalized” following the October private placement and views RT-114’s entry into the clinic as a key step as it carries momentum into 2026.
About Rani Therapeutics (NASDAQ:RANI)
Rani Therapeutics is a clinical-stage biopharmaceutical company developing oral delivery technologies for large-molecule drugs. The company’s proprietary RaniPill platform is designed to enable the gastrointestinal delivery of biologic therapies traditionally administered via injection. Through a swallowable capsule that autonomously deploys a microscopic injector in the small intestine, Rani aims to improve patient convenience and adherence for peptide and protein therapies, including insulin and other hormones.
Since its founding in 2012, Rani Therapeutics has advanced its lead programs through early-phase clinical trials, demonstrating proof-of-concept for oral insulin delivery.
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