Rani Therapeutics (NASDAQ:RANI) outlined its strategy to expand the use of its RaniPill oral biologic-delivery platform through a mix of technology partnerships, selectively licensed product programs and investments in manufacturing capacity.
Chief Executive Officer Talat Imran described the clinical-stage biotechnology company’s RaniPill as a “swallowable auto-injector” designed to deliver biologic medicines in the small intestine. According to Imran, the capsule dissolves in the intestine, where an internal reaction expands a balloon and delivers a dissolvable needle through the gut wall. The remaining components are excreted.
Chugai partnership and licensing strategy
The company highlighted its agreement with Chugai Pharmaceutical, which Imran said followed roughly two years of diligence and testing of Chugai molecules. The agreement initially covered a rare-disease candidate and was later expanded after additional diligence, he said.
Imran said the collaboration now includes 11 targets, with pre-negotiated economic terms for five additional programs, primarily in high-value immunology categories. He described the deal as validation for Rani’s platform and said partnerships can provide cash to support the company’s operating runway.
Rani expects to pursue additional agreements with drug developers, though Imran said it also sees value in selectively obtaining product licenses rather than solely licensing its technology. The company does not plan to run late-stage studies or build a commercial organization, he said, characterizing Rani primarily as a platform company focused on oral delivery of biologics.
“We’ll have a mix of these over time,” Imran said, referring to technology and product licensing arrangements.
RT-114 obesity program advances
Rani recently reported Phase 1A bioavailability data for RT-114, an oral version of ProGen’s PG-102, a GLP-1/GLP-2 Fc-fusion protein being evaluated for obesity-related applications. Imran said the study showed greater than 150% relative bioavailability compared with subcutaneous administration.
He said the study showed variability similar to subcutaneous dosing, with adverse events consistent with the observed exposure level and no new adverse events attributed to the RaniPill. The company views the findings as supportive of potentially weekly oral dosing.
Rani plans to add another Phase 1A cohort to confirm the relationship between oral and subcutaneous dosing, with data expected before the end of the year. It then expects to begin a Phase 1B study in obese patients. Imran said that eight-week study is expected to provide data on weight loss, safety and tolerability in the first half of 2027.
The company expects to use a lower drug dose in future work because of the reported oral bioavailability. The additional Phase 1A cohort is intended to help determine the dose that will be manufactured for the Phase 1B trial.
Imran said GLP-2 is intended to complement GLP-1 by supporting lean body mass and micronutrient absorption, while potentially improving gut health and lowering local inflammation. He said the program is intended to target tolerability and convenience rather than 25% weight loss.
Broader obesity and immunology opportunities
Rani also discussed its collaboration with PegBio, which provides the company access to PegBio’s library of incretin candidates. Imran said the companies may evaluate multi-agonists, siRNA programs and ultra-long-acting molecules, with potential future agreements around selected assets. The arrangement does not restrict Rani from pursuing other opportunities, he said.
Beyond obesity, Rani plans to expand its immunology efforts. The company has supply agreements with Celltrion for biosimilar versions of HUMIRA and STELARA, Imran said. Rani has already brought the STELARA biosimilar into the clinic and generated data, he added.
Imran said a multiple-ascending-dose efficacy study in psoriasis patients could potentially provide data within about 12 weeks. He also cited the potential for a weekly oral HUMIRA regimen, noting that changes in dose schedules could potentially optimize patient outcomes without adding the burden of more injections.
Cash runway and manufacturing scale-up
Chief Financial Officer Nick Maestas said Rani reported $43 million in cash and marketable securities in its first-quarter report. At that time, the company projected that the balance would fund operations into the fourth quarter of 2027, including a buffer beyond the anticipated RT-114 clinical catalysts.
Rani is also expanding manufacturing capacity for the RaniPill. Imran said the company is rolling out a production line capable of 1,500 pills per day, which it believes could support commercial rare-disease programs. It is also building a 10,000-pill-per-day line for potential immunology-scale production and expects eventually to expand to 50,000 pills per day to support obesity programs.
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.
