Rani Therapeutics Eyes 2027 Obesity Data as Oral Biologics Platform Advances

Key Points

• Rani Therapeutics’ RaniPill platform is designed to deliver biologics, peptides and other large molecules into the small intestine, with the company reporting more than 250 devices administered across four clinical studies.
• Its RT-114 obesity program, an oral version of ProGen’s PG-102 GLP-1/GLP-2 agonist, achieved more than 150% bioavailability versus a matched subcutaneous dose in a 30-person Phase 1 study. Rani plans to start a repeat-dose Phase 1B trial by year-end, with data expected in 2027.
• Rani ended June with $53 million in cash and securities and expects its runway to extend through the fourth quarter of 2027. The company is also pursuing milestone-generating collaborations with Chugai and PegBio, including a potential Chugai milestone report in 2027.

Rani Therapeutics NASDAQ: RANI outlined progress for its oral biologics delivery platform, including plans to advance its obesity program RT-114 and expectations for additional milestones from its collaboration with Chugai.

Chief Executive Officer Talat Imran said the clinical-stage biotechnology company has developed a swallowable device designed to deliver biologic medicines in the small intestine with bioavailability comparable to subcutaneous injection. The RaniPill is intended to administer biologics including monoclonal antibodies, proteins, peptides and oligonucleotides orally.

According to Imran, the device functions as a “swallowable auto-injector.” After reaching the small intestine, an effervescent reaction inflates and aligns a balloon containing a microsyringe. The syringe injects the drug into the intestinal wall, where Imran said there are no sharp pain receptors. The needle dissolves after administration, while the deflated balloon is excreted.

Imran said Rani has completed four clinical studies, including a repeat-dose study, and has administered more than 250 RaniPills. He said the company has delivered drugs including STELARA and factor VIII in human studies.

RT-114 Obesity Program

Chief Business Officer Kate McKinley discussed Rani’s partnership with South Korea-based ProGen to develop RT-114, an oral version of ProGen’s PG-102, a GLP-1/GLP-2 dual agonist. The companies share development costs equally, jointly own intellectual property and will split future revenue. ProGen holds rights in Asia, while Rani holds rights in the U.S., Europe, the U.K., Australia and Canada.

McKinley said Rani’s Phase 1 study in 30 healthy volunteers showed PG-102 delivered through the RaniPill achieved bioavailability greater than 150% of a matched 12-milligram subcutaneous dose. The study used the same dose in both the oral and subcutaneous arms, she said, and reported no device-related adverse events.

The company said exposure was not variable between treatment arms or among patients. Reported adverse events were consistent with the drug class and were mild to moderate, transient gastrointestinal events, McKinley said.

Rani plans to add 15 volunteers to the Phase 1A study. Those participants will receive two 12-milligram RaniPill doses, for a total dose of 24 milligrams. The expansion is intended to further characterize the relationship between oral and subcutaneous pharmacokinetics and help determine dosing for a Phase 1B trial.

The Phase 1B repeat-dose obesity study is expected to begin by the end of the year, with data anticipated in 2027. McKinley said Rani believes an oral, weekly version of PG-102 could offer competitive weight loss with a potentially more tolerable adverse-event profile than other obesity therapies, though the company did not provide a target weight-loss figure.

Imran said ProGen’s subcutaneous data have suggested faster titration and lower rates of nausea and vomiting than other incretin therapies. He also cited potential preservation of lean body mass as a feature that ProGen plans to evaluate further in future studies.

Additional Partnerships and Platform Strategy

Rani also highlighted its agreement with Chugai involving an antibody program in development for hemophilia. The arrangement included $10 million upfront, up to $18 million in technology-transfer payments, $57 million in development milestones, $100 million in sales milestones and single-digit royalties, according to the discussion. Chugai also has options on up to five additional targets.

McKinley said certain early Chugai milestones are tied to Rani’s platform and manufacturing progress. While the company did not provide exact timing, she said Rani expects to report on at least one milestone in 2027.

The company also entered a collaboration with PegBio covering obesity and metabolic molecules. McKinley said PegBio has an approved GLP product in China and a pipeline that includes penta-agonists, tri-agonists, a MariTide-like drug and siRNA programs. Rani expects to test multiple partner compounds through its delivery platform and potentially seek additional partners or further invest in selected programs.

Cash Runway and Manufacturing

Chief Financial Officer Nic Maestas said Rani ended June with $53 million in cash and securities following a $20 million registered direct offering led by a sovereign wealth fund. The company’s current cash runway guidance extends through 2027.

Maestas said Rani had previously projected runway into 2028 after its October 2025 financing and Chugai agreement, then updated guidance in March to the fourth quarter of 2027. He attributed the revisions to increased investment in the platform, debt retirement and a more conservative approach to excluding anticipated Chugai milestone payments from current runway guidance.

Imran said the RaniPill was designed without electronics and uses materials including plastic, sugar and effervescent components. He said the company expects manufacturing costs to decline with scale, particularly for high-volume obesity programs. He also said partner-funded development and potential upfront and milestone payments from future option exercises could help support the company’s pipeline.

About Rani Therapeutics (NASDAQ:RANI)

Rani Therapeutics Holdings, Inc is a biotechnology company developing oral delivery technologies for biologic medicines that are typically administered by injection. The company's platform is designed to transport therapeutic molecules through the stomach and release them in the small intestine, where they can be absorbed into the bloodstream.

Its primary technology, the RaniPill capsule, is a robotic oral delivery system intended to deliver biologics, peptides and other large-molecule therapies.

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