Company Description
Rani Therapeutics Holdings, Inc. (Nasdaq: RANI) is a clinical-stage biotherapeutics company in the pharmaceutical preparation manufacturing industry. According to the company’s public disclosures and press releases, Rani Therapeutics is focused on advancing technologies for the oral delivery of biologics and drugs. Its work is centered on replacing subcutaneous injections or intravenous infusions of biologic therapies with oral dosing, aiming to provide an alternative route of administration for complex drug substances.
The company has developed the RaniPill® capsule, described in multiple releases as a novel, proprietary and patented platform technology. The RaniPill capsule is intended to deliver drug substances that are typically administered by injection. Rani states that the platform is designed to deliver a wide variety of biologic drug payloads and that it has conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using the RaniPill capsule technology.
Core technology and development focus
Rani Therapeutics characterizes the RaniPill capsule as an oral delivery platform intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing. Company materials explain that the technology is being applied to drug candidates where injectable administration can be burdensome for patients. Rani reports that its studies with the RaniPill capsule have focused on demonstrating comparable bioavailability and pharmacokinetic profiles to injectable routes in preclinical and early clinical settings.
In addition to the RaniPill capsule, Rani is also developing RaniPill HC. Based on the company’s description, RaniPill HC is intended to enable the delivery of drug payloads in liquid form with high bioavailability. This expands the potential applications of the platform to biologics and drugs that may be formulated as liquids, while maintaining an oral route of administration.
Pipeline programs and collaborations
Rani Therapeutics describes itself as a clinical-stage company, with several programs built on the RaniPill platform. Among these, the company has highlighted RT-114, an orally administered RaniPill capsule containing a GLP-1/GLP-2 dual agonist (PG-102) being developed for the treatment of obesity. In company announcements, Rani reports that preclinical testing of RT-114 in animal models showed that the RaniPill capsule delivered PG-102 orally with bioavailability, pharmacokinetics and weight loss comparable to subcutaneous injection.
Rani has also disclosed a collaboration agreement with ProGen Co., Ltd. for RT-114 in the field of weight management, including obesity, weight reduction and weight maintenance. Under that agreement, Rani and ProGen share development responsibilities and plan to share development costs, as well as operating profits and losses from potential commercialization of RT-114. Rani has indicated that it leads preclinical activities through Phase 1 clinical trials and that, after initiation of the first Phase 2 clinical trial, it expects to lead development and commercialization of RT-114 in the United States, Canada, Europe (including the United Kingdom) and Australia, while ProGen leads in other countries.
In addition, Rani has announced a Collaboration and License Agreement with Chugai Pharmaceutical Co., Ltd. for the development and commercialization of an oral product that combines Rani’s RaniPill HC oral delivery device with a Chugai rare disease antibody in development. Under this agreement, Rani LLC (an operating subsidiary) and Chugai will collaborate to develop, manufacture, seek regulatory approvals for and, if approved, commercialize a product for use in humans. The agreement provides for an upfront payment, technology transfer milestones, development milestones, sales-based milestones and single-digit royalties on net sales to Rani. Rani has also disclosed that Chugai may extend its rights to additional drug targets under similar terms, potentially increasing the overall value of the collaboration.
Clinical and preclinical data generation
Across its public communications, Rani Therapeutics emphasizes that it has successfully conducted several preclinical and clinical studies using the RaniPill capsule technology. These studies have been described as evaluating safety, tolerability and bioavailability. For example, the company has reported preclinical data on oral delivery of semaglutide via the RaniPill capsule (RT-116) and on oral delivery of a bispecific GLP-1/GLP-2 receptor agonist (PG-102) via RT-114, noting that in canine models the oral delivery via RaniPill demonstrated bioequivalence or comparable bioavailability and weight loss to subcutaneous injection.
Rani has also announced the initiation of a Phase 1 clinical trial of RT-114 to evaluate safety, tolerability, bioavailability, pharmacokinetics and pharmacodynamics of single and multiple doses of RT-114 for the treatment of obesity. This reflects the company’s stated focus on advancing oral biologic therapies into human clinical development, particularly in areas where injectable treatments are common.
Capital markets activity and listing
Rani Therapeutics Holdings, Inc. states that its Class A common stock trades on The Nasdaq Stock Market LLC under the symbol "RANI". The company has reported multiple equity financings, including private placements and registered offerings of Class A common stock and pre-funded warrants, as well as the issuance of warrants to purchase additional shares. These transactions have been described in company press releases and in Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission (SEC).
In an 8-K filing dated June 20, 2025, Rani disclosed that it received a Nasdaq notice regarding non-compliance with the minimum bid price requirement for continued listing on The Nasdaq Global Market. The notice stated that the company’s Class A common stock had closed below the required minimum bid price of $1.00 per share for 30 consecutive business days. The filing explains that Rani has an initial 180-day period to regain compliance and may be eligible for an additional 180-day period if it transfers to The Nasdaq Capital Market and meets specified conditions. The company indicated its intention to monitor the closing bid price and consider available options to address the deficiency.
Governance and corporate structure
Rani Therapeutics Holdings, Inc. has disclosed a capital structure that includes Class A, Class B and Class C common stock, with Class A common stock listed on Nasdaq. The company has also reported changes to its board of directors, including the appointment of new directors associated with institutional investors that participated in a private placement, and the reconstitution of board committees such as the Audit Committee, Compensation Committee, and Nominating and Corporate Governance Committee.
In connection with its financings, Rani has entered into securities purchase agreements, registration rights agreements and loan agreement amendments, as described in its Form 8-K filings. These documents outline terms related to equity issuance, warrant coverage, registration of resale shares and conversion of a portion of outstanding debt into equity.
Business model and sector context
Based on its disclosures, Rani Therapeutics operates as a clinical-stage biotherapeutics company within the manufacturing sector, specifically in pharmaceutical preparation manufacturing. Its business model is centered on developing and advancing the RaniPill platform and related technologies to enable oral delivery of biologics and drugs. Revenue opportunities described in company materials include collaboration and license agreements, such as the agreement with Chugai, which provide for upfront payments, milestone payments and royalties tied to successful development and commercialization of products that incorporate the RaniPill technology.
The company’s public statements emphasize its focus on oral biologic therapies for chronic diseases, including obesity and rare diseases, where injectable biologics are common. By pursuing collaborations with pharmaceutical partners and advancing its own pipeline candidates, Rani positions the RaniPill platform as a technology that may support the development of oral versions of therapies that are otherwise administered by injection.
Risk disclosures and regulatory reporting
Rani Therapeutics regularly includes forward-looking statements in its press releases, accompanied by cautionary language referencing risks and uncertainties. The company directs readers to its annual report on Form 10-K and subsequent SEC filings for detailed risk factors and additional information about its business. It also files Current Reports on Form 8-K to report material events, such as financial results, collaboration agreements, financing transactions, board changes and listing compliance matters.
Key points for investors and observers
- Rani Therapeutics is a clinical-stage biotherapeutics company focused on oral delivery of biologics and drugs.
- The company has developed the RaniPill® capsule, a proprietary and patented platform intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing.
- Rani is also developing RaniPill HC, intended to enable delivery of drug payloads in liquid form with high bioavailability.
- Pipeline efforts include RT-114, an orally administered RaniPill capsule containing a GLP-1/GLP-2 dual agonist (PG-102) for the treatment of obesity, supported by preclinical data showing comparable bioavailability and weight loss to subcutaneous injection in animal models.
- The company has entered into collaboration agreements, including with ProGen Co., Ltd. for RT-114 in weight management and with Chugai Pharmaceutical Co., Ltd. for an oral product combining RaniPill HC with a rare disease antibody.
- Rani’s Class A common stock is listed on Nasdaq under the symbol RANI, and the company has reported equity financings, warrant issuances and a Nasdaq notice regarding minimum bid price compliance.
- Rani emphasizes that it has conducted several preclinical and clinical studies with the RaniPill capsule to evaluate safety, tolerability and bioavailability.