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Item 1. Business

2026-03-26 compared with 2025-03-31 · 235 added, 267 removed, 564 unchanged (47% of the section changed)

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We are also developing a high-capacity version of the RaniPill capsule known as the RaniPill HC, which is intended to enable delivery of drug payloads up to 200µL in liquid form with high bioavailability.

We have tested preclinically the RaniPill HC with multiple therapeutics, including antibodies and a peptide.

We intend to initiate clinical testing of the RaniPill HC in mid-2025.

We have tested preclinically the RaniPill HC with multiple therapeutics, including multiple different antibodies and peptides.

In December 2025, we initiated a Phase 1 clinical trial with RT-114, a RaniPill HC capsule containing a GLP-1/GLP-2 dual agonist (PG-102), for the treatment of obesity.

We believe, the RaniPill capsule technology could enable us to deliver most biologics currently on the market with convenient, oral dosing.

Data Overview

We have completed three Phase 1 clinical trials with the RaniPill capsule technology.

In February 2024, we announced completion of a Phase 1 clinical trial with RT-111, a RaniPill GO capsule containing our proprietary formulation of an ustekinumab biosimilar supplied by Celltrion, Inc.

(“Celltrion”), in Australia.

The study evaluated the safety and tolerability of a single administration of RT-111 in healthy adult volunteers.

The study met all its endpoints, RT-111 was well tolerated and delivered ustekinumab biosimilar with high bioavailability.

No serious adverse events were reported in the study.

In 2022, we completed a Phase 1 clinical trial with RT-102, a RaniPill GO capsule containing our proprietary formulation of parathyroid hormone (1-34) (“PTH”), in Australia.

The study involved a single-ascending dose portion and a seven-day repeat-dose portion.

The Phase 1 study met all of its endpoints, RT-102 was well tolerated and delivered PTH with high bioavailability (more than 300% greater bioavailability than subcutaneous injection of Forteo (teriparatide)).

No serious adverse events were reported in the study.

In 2019, we completed a Phase 1 study with RT-101, a RaniPill GO capsule containing our proprietary formulation of octreotide, in Australia.

The Phase 1 study met all of its endpoints, RT-101 was well tolerated and delivered octreotide with high bioavailability (comparable to subcutaneous injection of octreotide).

No serious adverse events were reported in the study.

As of December 31, 2024, we have administered the RaniPill capsule 233 times to 146 human subjects in clinical trials, including seven-day repeat-dosing in ten subjects in our Phase 1 study of RT-102.

This is in addition to oral administrations of the RaniPill capsule, without a drug or needle, in non-significant risk studies.

In our clinical studies, our product candidates were generally well tolerated and no serious adverse events were observed.

Preclinically, we have tested 19 molecules in the RaniPill capsule, including ten antibodies, seven peptides, one Fc-fusion protein and one large protein.

We have conducted preclinical testing of more than 7,000 RaniPill capsules in vivo and in vitro.

In October 2023, we announced preclinical data from a 60-day, repeat oral-administration good laboratory practices (“GLP”) safety study of the RaniPill capsule in healthy animals.

The RaniPill capsule was well tolerated with no treatment-related adverse events and all animals remained clinically healthy throughout the study.

As of January 1, 2025, we had tested more than 350 RaniPill HC devices in vivo including delivery of multiple different antibodies and peptides.

We intend to initiate clinical testing of the RaniPill HC in mid-2025.

We do not have any products approved for sale, and we have not yet generated any revenue from sales of a commercial product.

Our ability to generate product revenue sufficient to achieve profitability, if ever, will depend on the successful development of the RaniPill capsule, which we expect will take a number of years.

Given our stage of development, we have not yet established a commercial organization or distribution capabilities, and we have no experience as a company in marketing drugs or a drug-delivery platform.

When, and if, any of our product candidates are approved for commercialization, we plan to develop a commercialization infrastructure or engage commercial sales organizations or distributors for those products in the United States, Europe, Asia, and potentially in certain other key markets.

We may also rely on partnerships to provide commercialization infrastructure, including sales, marketing, and commercial distribution.

As is common with biotechnology companies, we rely on third-party suppliers for the supply of raw materials and active pharmaceutical ingredients ("APIs") and drug substances required for the production of our product candidates.

In addition, we work with third parties to manufacture and develop biologics and drugs for inclusion in the current RaniPill capsule and RaniPill HC.

Design work, prototyping and pilot manufacturing are performed in house, and we have utilized third-party engineering firms to assist with the design of manufacturing lines that support our supply of the current RaniPill capsule and RaniPill HC.

Certain of our suppliers of components and materials are single source suppliers.

We believe our vertically integrated manufacturing strategy will offer significant advantages, including rapid product iteration, control over our product quality and the ability to rapidly scale our manufacturing capacity.

This capability also allows us to develop future generations of products while maintaining the confidentiality of our intellectual property.

Our vertically integrated manufacturing strategy will result in material future capital outlays and fixed costs related to constructing and operating a manufacturing facility.

We have invested and plan to continue to invest in automated manufacturing production lines for the RaniPill capsule.

Those assets deemed to have an alternative future use have been capitalized as property and equipment while those projects related to our assets determined to not have an alternative future use have been expensed as research and development costs.

Business Update

Collaboration

In June 2024, we entered into a Collaboration Agreement (the “ProGen Collaboration Agreement”) with ProGen Co., Ltd.

Under the ProGen Collaboration Agreement, the parties will collaborate to manufacture, develop, seek regulatory approvals for and, if approved, commercialize a product (RT-114) combining ProGen’s GLP-1/GLP-2 dual agonist compound, PG-102, and the RaniPill HC oral delivery device (the “Device”) in the field of weight management (including without limitation obesity, weight reduction and weight maintenance) in humans (the “ProGen Collaboration”).

Under the ProGen Collaboration Agreement, development costs, as well as operating profits and losses from the commercialization of the Product, will be equally shared by us and ProGen.

We and ProGen each granted to the other party an exclusive right and license (except with respect to the other party’s affiliates and sublicensees) to certain intellectual property to develop RT-114 for weight management and an exclusive right and license to seek regulatory approval for, and to use, sell, offer to sell, import and commercialize RT-114 in their assigned territories.

The parties share responsibility for the development of RT-114 worldwide, with Rani leading such development for preclinical activities through Phase 1 clinical trials.

After initiation of the first Phase 2 clinical trial, we will lead development and commercialization of RT-114 in the United States, Canada, Europe (including the United Kingdom) and Australia, and ProGen will lead development and commercialization in all other countries.

See “License and Evaluation Agreements – ProGen Co., Ltd.” below.

In October 2024, we entered into a securities purchase agreement (the “October Securities Purchase Agreement”) with an institutional investor relating to the issuance and sale of:

(i) 3,000,000 shares of our Class A common stock, (ii) pre-funded warrants to purchase 333,333 shares of Class A common stock, and (iii) Series C common warrants, which accompany the Class A common stock and pre-funded warrants, to purchase an aggregate of 3,333,333 shares of Class A common stock (the “October Offering”).

The aggregate net proceeds from the October Offering totaled $9.4 million, after deducting placement agent fees and other offering expenses payable by us, and excluding potential proceeds, if any, from the exercise of the pre-funded warrants and Series C common warrants issued in the October Offering.

In October 2024, the pre-funded warrants were fully exercised for de minimis proceeds.

In July 2024, we entered into a securities purchase agreement (the “July Securities Purchase Agreement”) with an institutional investor relating to the issuance and sale of:

(i) 2,800,000 shares of its Class A common stock, (ii) pre-funded warrants to purchase 446,753 shares of Class A common stock, (iii) Series A common warrants, which accompany the Class A common stock and pre-funded warrants, to purchase an aggregate of 3,246,753 shares of Class A common stock (the “Series A Warrants”) and (iv) Series B common warrants, which accompany the Class A common stock and pre-funded warrants, to purchase an aggregate of 3,246,753 shares of Class A common stock (the “July Offering”).

Pursuant to the October Securities Purchase Agreement, the Series A Warrants from the July Offering were cancelled.

The aggregate net proceeds from the July Offering totaled $8.9 million, after deducting placement agent fees and other offering expenses, and excluding potential proceeds, if any, from the exercise of the Series B common warrants issued in the July Offering.

In August 2024, the pre-funded warrants were fully exercised for de minimis proceeds.

Preclinical Data

In March 2025, we announced preclinical data demonstrating bioequivalence of RT-114, a GLP-1/GLP-2 dual agonist (PG-102) delivered orally via the RaniPill capsule, to subcutaneously administered PG-102.

RT-114 yielded a relative bioavailability of 111% compared to PG-102 delivered subcutaneously with comparable pharmacokinetic profiles and weight loss.

RT-114 was well tolerated and was excreted without sequelae in all subjects.

For information regarding the preclinical study and the RT-114 program, see the section titled “Our Pipeline Programs - RT-114:

GLP-1/GLP-2 dual agonist for the treatment of obesity” for more information.

In February 2025, we announced preclinical data demonstrating successful oral delivery of the glucagon-like peptide-1 receptor (“GLP-1”) agonist semaglutide via the RaniPill HC (“RT-116”).

In the study, RT-116 demonstrated comparable bioavailability, pharmacokinetics and weight loss to subcutaneous (“SC”) administration of semaglutide.

Further, RT-116 was well tolerated with no serious adverse events.

In October 2024, we announced new pharmacokinetic data from a preclinical study evaluating a GLP-1, GIP and glucagon receptors incretin triagonist with a delivery method mimicking the RaniPill route of administration.

The preclinical study evaluated the pharmacokinetic (“PK”) and pharmacodynamic (“PD”) profiles of an incretin triagonist (GLP-1, GIP, glucagon

receptors) when delivered via an endoscope-guided transenteric administration to mimic the RaniPill route of administration, versus the traditional administration route of subcutaneous injection.

The study was conducted in canines separated into two groups.

In Group 1 (N=3), 0.12 mg/kg of drug was administered via transenteric delivery by endoscope.

In Group 2 (N=5), 0.12 mg/kg of drug was administered by SC injection.

Blood samples were collected over 2 weeks for analysis of serum drug concentrations and various PD and safety biomarkers.

A single dose of drug delivered via either transenteric or SC routes elicited rapid decreases in body weight and serum lipids.

Weight loss observed following transenteric delivery was 9.7 ± 2.5 % versus 6.9 ± 2.1 % following SC injection and is believed to be due to early satiety leading to reduced caloric intake.

Additionally, the bioavailability of drug delivered via the transenteric route was comparable to that of drug delivered via the SC route at the same dose.

The drug was well tolerated in both groups with no serious adverse events (SAEs) observed or changes in safety markers examined.

Transenteric delivery yielded 80% relative bioavailability versus SC and differences between PK parameters (AUC, C max , T max ) were not statistically significant.

CEO Compensation

In November 2023, the Company’s Board of Directors (“Board”) approved a reduction in the annual salary of Talat Imran, the Company’s Chief Executive Officer, from $520,000 to $100,000, effective November 1, 2023 through December 31, 2024 or until such time as the Company receives gross proceeds of $50,000,000 or more, in the aggregate, from equity financing and/or one or more non-dilutive strategic, licensing or partnering transactions (the “Financing Threshold”).

In November 2024, the Board approved to extend the reduction in annual salary of Talat Imran through December 31, 2025 or until the Financing Threshold is met.

In October 2025, we entered into a Collaboration and License Agreement (the “Chugai Collaboration and License Agreement”) with Chugai Pharmaceutical Co., Ltd.

(“Chugai”) to develop, manufacture, seek regulatory approvals for and, if approved, commercialize a product (the “Chugai Product”) combining Chugai’s antibody (the “Compound”), which is in development for hemophilia, and the RaniPill HC oral delivery device for use in humans.

Under the Chugai Collaboration and License Agreement, we received a $10.0 million upfront payment and we are eligible to receive up to $18.0 million in technology transfer milestones, up to $57.0 million in development milestones, up to $100.0 million in a series of sales-based milestones, contingent upon approval and the commercial success of the Chugai Product, and single digit royalties on net sales upon approval and successful commercialization of the Chugai Product.

Of the $10.0 million upfront payment, $8.0 million was received in cash and $2.0 million remains in accounts receivable relates to tax withheld by the Japanese tax authorities, which is expected to be

refunded to us upon submission and acceptance of the required residency certificate.

See “License and Evaluation Agreements – Chugai Pharmaceutical Co., Ltd.” below for more information.

Financing Update

In October 2025, we entered into a securities purchase agreement (the "Private Placement") pursuant to which we sold (i) 42,633,337 shares of our Class A common stock (the “Class A Common Stock”), (ii) warrants to purchase up to an aggregate of 125,000,004 shares of Class A Common Stock or pre-funded warrants (the “Common Warrants”) and (iii) pre-funded warrants to purchase up to an aggregate of 82,366,667 shares of Class A Common Stock (the “Pre-Funded Warrants”), for the aggregate purchase price of approximately $60.3 million (including conversion of the loan amount of $6.0 million described below).

The Common Warrants became exercisable following the effective date of stockholder approval in December 2025 and have a term of five years following the initial exercise date.

The Common Warrants have an exercise price of $0.48 per share.

The Pre-Funded Warrants are exercisable immediately, have an unlimited term and an exercise price of $0.0001 per share.

In October 2025, we entered into an amendment to the loan and security agreement (the "LSA Amendment") with the Avenue Venture Opportunities Fund, L.P (the "Lender"), pursuant to which the Lender, among other things, converted $6.0 million of outstanding term loans (the "Loans") into 12,500,000 shares of Class A Common Stock (or Pre-Funded Warrants in lieu thereof) and Common Warrants to purchase up to 12,500,000 shares of Class A Common Stock (or Pre-Funded Warrants in lieu thereof), on the same terms as other investors in the Private Placement.

In January 2026, the Lender exercised 2,099,844 shares of Pre-Funded Warrants, resulting in 80,266,823 shares of Pre-Funded Warrants outstanding.

We received de minimis proceeds from the exercise.

In December 2025, we repaid all outstanding amounts under the loan and security agreement and related supplement (the "Loan Agreement"), including the remaining principal balance of $6.2 million, accrued interest, a final payment of $1.7 million, and a prepayment fee of $0.1 million.

We recognized a loss on the extinguishment of the debt of $0.6 million.

Upon repayment of these amounts, all obligations under the Loan Agreement were fully satisfied.

We no longer have any outstanding debt obligations as of December 31, 2025.

In July 2025, we entered into a securities purchase agreement (the "July 2025 Securities Purchase Agreement") with an institutional investor, relating to the issuance and sale of 4,354,000 shares of Class A common stock and pre-funded warrants to purchase 3,146,000 shares of Class A common stock (the "Offering").

The pre-funded warrants are exercisable immediately following the closing date of the Offering and have an unlimited term and an exercise price of $0.0001 per share.

The Offering price was $0.40 per share of Class A common stock and $0.3999 per pre-funded warrant for total gross proceeds of $3.0 million.

After closing of the Offering, the institutional investor fully exercised all pre-funded warrants.

In May 2025, we entered into a letter agreement (the "Letter Agreement") with an existing institutional investor (the “Equity Investor”) pursuant to which the Equity Investor exercised for cash all outstanding Series B and Series C warrants at a reduced exercise price of $0.65 per share, for net proceeds of $3.9 million in consideration for the issuance of a new Series D common stock warrant (the "Series D Warrant") to purchase an aggregate of 13,160,172 shares of Class A common stock with the exercise price of $0.65 per share.

In October 2025, the Equity Investor exercised 6,967,150 shares of Series D Warrants, resulting in 6,193,022 shares of Series D Warrants remained outstanding.

We received cash proceeds of $4.5 million as a result of the exercise.

Pipeline Overview

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* Clinical timelines are subject to potential regulatory agency review delays

** RT-114 is the subject of a worldwide collaboration with ProGen Co.

***Ustekinumab and adalimumab biosimilars are supplied by Celltrion.

Celltrion grants us a license and drug supply for each drug.

** RT-114 is the subject of a worldwide collaboration with ProGen Co, Ltd.

*** Ustekinumab and adalimumab biosimilars are supplied by Celltrion, Inc.

Celltrion grants Rani a license and drug supply for each drug.

****RT-117 is the subject of a worldwide collaboration and license with Chugai Pharmaceutical Co., Ltd.

Our Pipeline Programs

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The global market for anti-obesity treatments is estimated to reach $100 billion by 2030.

Several anti-obesity treatments are currently available, including GLP-1 agonist semaglutide (marketed as Wegovy® by Novo Nordisk A/S) and GLP-1/gastric inhibitory polypeptide (GIP) tirzepatide (marketed as

Zepbound® by Eli Lilly & Co.).

Many potential treatments are in development for obesity and weight management.

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We are targeting a profile for RT-114 of once a week oral dosing, potential for better tolerability with more frequent, smaller doses than injectables, potential for less frequent administration than oral competitors and less API required compared to chemistry-based oral molecules.

We are conducting preclinical studies with RT-114.

We have conducted several preclinical studies with RT-114.

RT-114 is the subject of a collaboration between ProGen and us.

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Average peak weight loss was the same in both groups with greater variability with subcutaneous dosing (6.7% ± 0.5% for RT-114 and 6.7% ± 2.2% for subcutaneous PG-102).

In July 2025, we presented the preclinical data at the Endocrine Society’s Annual Meeting (ENDO 2025).

ProGen’s preclinical studies demonstrated that treatment with PG-102 resulted in greater glycemic control while inducing a similar degree of body weight loss versus semaglutide and tirzepatide.

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In addition, preclinical studies of PG-102 have demonstrated in a diet-induced obesity (DIO) mouse model weight loss and improved body composition (fat versus lean mass loss) under similar weight loss condition compared to dapiglutide and tirzepatide.

We intend to share an update following completion of the Phase 1 clinical trial in 2027.

Data are shown in ±SEM

HFD=high fat diet.

We intend to initiate a Phase 1 clinical trial of RT-114 in mid-2025.

Clinical trials

In December 2025, we initiated a Phase 1 clinical trial with RT-114.

The Phase 1 trial will evaluate the safety, tolerability, bioavailability, and pharmacokinetics / pharmacodynamics of single and multiple doses of RT-114 for the treatment of obesity.

The single-center Phase 1 study of RT-114 is being conducted in Australia.

The single dose portion of the study will evaluate the safety, tolerability and bioavailability of RT-114 administered in up to 30 healthy human participants.

This part of the trial will consist of two cohorts, with one cohort evaluating RT-114 containing 12 mg of PG-102, administered orally as a RaniPill capsule.

The second cohort, as the control group, will receive 12 mg of PG-102 via subcutaneous injection.

We intend to share an update following completion of the Phase 1 study.

Semaglutide for the treatment of obesity

Market overview

Semaglutide is a glucagon-like peptide-1 receptor (“GLP-1”) agonist marketed as Wegovy® by Novo Nordisk A/S and is approved by the FDA and European Medicines Agency (“EMA”) to treat obesity.

In January 2026, an oral version of semaglutide (oral Wegovy®) was approved by the FDA as a once-daily tablet for chronic weight management in adults with obesity or overweight.

Early adoption of oral Wegovy® appears strong, according to recent data from Spherix Global Insights and Truveta Research.

Oral Wegovy® must be taken daily on an empty stomach, with patients having to wait at least 30 minutes after taking the pill before eating, drinking, or taking other oral medications.

In addition, gastrointestinal side effects have occurred frequently with oral Wegovy®, particularly during the initial weeks of treatment, with roughly 75% of users experiencing them in trials.

Our solution:

We are developing RT-116, a RaniPill HC capsule containing semaglutide for the treatment of obesity.

We believe that pharmacokinetic / pharmacodynamic data of semaglutide in RT-116 may support potential dosing of oral RT-116 on a weekly schedule, which may improve patient compliance.

We are targeting a profile for RT-116 of once a week oral dosing, with potential for better tolerability with more frequent, smaller doses than injectables, potential for less frequent administration than oral competitors and less API required compared to chemistry-based oral molecules.

Preclinical studies

In February 2025, we announced preclinical data demonstrating successful oral delivery of semaglutide via the RaniPill HC.

In the study, RT-116 demonstrated comparable bioavailability, pharmacokinetics and weight loss to subcutaneous (“SC”) administration of semaglutide.

Further, RT-116 was well tolerated with no serious adverse events.

In November 2025, we presented the RT-116 preclinical data at ObesityWeek® 2025.

The nonclinical pharmacokinetic and pharmacodynamic study was conducted to examine the effects of semaglutide delivered orally via the RaniPill HC (RT-116) versus a subcutaneous injection comparator group.

The 2x2 crossover study was conducted in two parts with a period of four weeks separating the two groups to evaluate the PK, PD and safety of RT-116.

Eight canines were randomized into two groups who received 0.5mg of semaglutide delivered via oral administration of the RaniPill HC (N=4) or subcutaneous injection (N=4).

Endpoints included plasma drug concentrations, body weight, food intake, lipid profile, and safety.

Data Highlights

Semaglutide was successfully delivered in 7 of 8 canines that received the RaniPill capsule.

Semaglutide administered via the RaniPill capsule was well tolerated with no serious adverse events.

Cmax, Tmax, and AUC were comparable for semaglutide administered via RaniPill capsule and subcutaneous administration of semaglutide.

Oral administration via the RaniPill capsule demonstrated bioavailability and biological activity comparable to subcutaneous administration.

The relative bioavailability of oral semaglutide was 107% versus subcutaneous administration.

Both groups saw comparable weight loss which appeared to be driven by decreased food intake that coincided with rises in plasma drug levels thus indicating there is a PD effect to treatment.

Both groups saw comparable moderate decreases in serum triglycerides and cholesterol.

The next step for this program is to initiate a Phase 1 clinical trial.

Anti-TNF-alpha antibody for the treatment of rheumatoid arthritis

Market overview

Anti-TNF-alpha antibodies such as adalimumab are used to treat a range of inflammatory disorders and are among the largest selling class of pharmaceutical drugs globally as measured by revenue.

Adalimumab, sold by AbbVie Inc.

under the brand name Humira, generated U.S.

sales of approximately $7.14 billion in 2024.

Adalimumab is approved by the FDA and EMA to treat a range of autoimmune conditions, including rheumatoid arthritis, psoriasis and Crohn’s disease.

alone, there are an estimated one and one-half million patients with rheumatoid arthritis, seven million with psoriasis, and three million with Crohn’s disease or ulcerative colitis.

At least eight Humira® biosimilars have entered the U.S.

market including Yuflyma®, a high-concentration, citrate-free adalimumab biosimilar marketed by Celltrion.

Patients who use adalimumab administer the drug through a subcutaneous injection once every two weeks.

Despite the painful injections required to administer it, adalimumab was the best-selling drug globally in 2020.

Our solution:

We are developing RT-105, the RaniPill capsule containing a formulation of adalimumab, for oral treatment of a host of inflammatory conditions, beginning with treatment of psoriatic arthritis and later expanding to other indications for which TNF-alpha inhibitors are approved.

We believe that the development of an orally administered anti-TNF-alpha antibody represents a significant market opportunity.

In June 2023, we entered into a License and Supply Agreement with Celltrion under which we received an exclusive license and supply of Celltrion’s adalimumab biosimilar for the development and commercialization of RT-105 worldwide, subject to a right of first negotiation for Celltrion.

Preclinical studies

We evaluated the performance of RT-105 containing an adalimumab biosimilar in awake canines and compared it to the performance of the adalimumab biosimilar given by way of subcutaneous and intravenous injection.

The PK profile for RT-105 was comparable to the profile for subcutaneous administration, and mean bioavailability for RT-105 was 49%, compared to 46% with subcutaneous injection.

Clinical trials

Endoscopic administration of adalimumab into the jejunum of healthy human volunteers

To assess whether the observations from preclinical studies regarding absorption of adalimumab through the intestinal wall translate to clinical trials, we conducted an endoscopic study in humans.

The study involved ten healthy volunteers and compared the PK of an approved formulation of adalimumab injected endoscopically into the jejunal intestinal wall, which mimics the RaniPill capsule route of administration, to that of an identical dose injected subcutaneously.

Blood samples were obtained at prescribed intervals during a 14-day study period.

PK profiles were similar with no notable differences observed in either area under the curve (“AUC”) or maximum serum concentration (“Cmax”).

The mean AUC was 62.7 ± 11.4 µg/ml*day*kg/mg for the subcutaneous group and 45.0 ± 29.0 µg/ml*day*kg/mg for the intrajejunal group.

No serious adverse events were noted in this study, and adverse events of headache and flu-like symptoms after intrajejunal administration resolved within 48 hours.

The results are consistent with data obtained in preclinical studies, confirming intrajejunal delivery as a viable route of delivery for adalimumab.

In November 2023, we paused development of RT-105 as part of a strategic focusing of the business.

If resumed, the next milestone for this program will be to initiate a Phase 1 clinical trial of RT-105.

Under the Celltrion Agreement for adalimumab, Celltrion has a right to terminate the agreement because we have not initiated a Phase 1 clinical trial with RT-105 within a certain period specified in the agreement.

Ustekinumab for the treatment of inflammatory conditions

38 unchanged sentences

In January 2023, we announced entering into a License and Supply Agreement with Celltrion under which we receive a license and supply of Celltrion’s ustekinumab biosimilar for development and commercialization of RT-111 worldwide.

We intend to advance clinical development of RT-111 at higher doses.

Parathyroid hormone (PTH) for the treatment of osteoporosis

Market overview

Osteoporosis is a bone disease where bone mineral density and bone mass decreases, leading to a decrease in bone strength that can increase the risk of fractures.

Osteoporosis affects women and men of all races and ethnic groups.

Osteoporosis can occur at any age, although the risk for developing the disease increases with age.

PTH is an effective bone-building treatment for osteoporosis.

PTH is a hormone secreted by the parathyroid glands that regulates serum calcium concentration and promotes bone growth.

PTH therapies are delivered by daily subcutaneous injections for up to two years.

Approximately ten million Americans suffer from osteoporosis;

however, we estimate that only a small fraction of this population is being treated with a form of PTH.

While there may be other reasons for this, we believe that patient aversion to daily injections may be a major factor.

As a result, non-bone-building and less effective antiresorptive drugs are used as first line therapies because they are available in oral form.

Teriparatide, a synthetic form of the natural human parathyroid hormone hPTH(1-34), is a PTH analog administered as a once-daily injection to treat osteoporosis, first developed by Eli Lilly and Company and sold under the brand name Forteo.

Another PTH analog injectable is Tymlos by Radius Health, Inc., which was approved in 2017.

A teriparatide biosimilar injectable by Pfenex, Inc.

was approved in 2019.

Annual sales revenue of PTH analogs and biosimilars globally in 2021 was approximately $2.0 billion.

Our solution:

We are developing RT-102, the RaniPill capsule containing our novel formulation of PTH, for oral treatment of osteoporosis.

We have worldwide commercial rights to RT-102.

In addition to the existing market, we believe there is an opportunity to expand the market by advancing RT-102 as a first line therapy for osteoporosis.

Preclinical pharmacodynamic study

We conducted a 6-week pharmacodynamic study of the RT-102 drug substance PTH (1-34) to evaluate the effect of daily RT-102 drug substance intraperitoneal injections on bone mineral density in a rodent model of osteoporosis.

The study compared two control groups of rodents undergoing sham surgery (N=10) and ovariectomy (N=10) receiving no drug, to three overiectomized groups each dosed with 5 mcg/kg per day of either RT-102 DS (N=10), teriparatide (N=10), or abaloparatide (N=10).

The study found that, following six weeks of treatment:

• RT-102 DS increased bone mineral density (“BMD”) in a rat model of osteoporosis.

• RT-102 DS delivered via the intraperitoneal (“IP”) route of administration was biologically active comparable to subcutaneously injected PTH analogs.

Clinical trials

In 2022, we completed a Phase 1 clinical trial with RT-102 in Australia.

The study involved a single-ascending dose portion (“Study Part 1”) and a seven-day repeat-dose portion (“Study Part 2”).

The Phase 1 study met all of its endpoints, RT-102 was well tolerated and delivery yielded high bioavailability (more than 300% greater bioavailability than subcutaneous injection).

No serious adverse events were reported in the study.

Study Part 1 - Topline Results

The single-center, open label, Study Part 1 was conducted in Australia.

The study evaluated the safety, tolerability, and pharmacokinetics of RT-102 in healthy adult female volunteers.

Of the 39 participants, 15 were administered RT-102 containing a single 20 μg dose of PTH and 14 were administered RT-102 containing a single 80 μg dose of PTH, while a control group of ten participants received a single 20 μg subcutaneous injection (SC) of Forteo (teriparatide), a commercial formulation of PTH for subcutaneous administration.

The endpoints of the study were safety and tolerability, and measurements of serum concentrations of RT-102 in healthy adult female volunteers.

• In Study Part 1, RT-102 was generally well tolerated, with no RaniPill-related adverse events (“AEs”) observed in study participants:

• 0% (0/15) of participants dosed with RT-102 20 μg experienced drug-related AEs.

• 14% (2/14) of participants dosed with of RT-102 80 μg experienced drug-related AEs.

• 50% (5/10) of participants dosed with 20 μg of Forteo SC experienced drug-related AEs.

• There were no serious adverse events (“SAEs”) noted during Study Part 1.

Per protocol, in instances where the RaniPill capsule did not exit the stomach within seven hours, participants were excluded from the study.

Based on the exclusion criteria, three participants were excluded from Study Part 1, one of whom experienced bloating, and one additional subject was excluded due to vomiting the capsule intact.

In all instances, the capsule remnants passed from all participants who ingested the RaniPill capsule.

Pharmacokinetics

• In Study Part 1, RT-102 (20 μg and 80 μg) orally delivered PTH with 300%-400% greater bioavailability than PTH delivered by Forteo SC (20 μg).

• RT-102 20 μg delivered PTH with lower, more sustained peak serum levels and higher area under the curve (“AUC”) than Forteo SC 20 μg.

Forteo SC 20 μg

AUC (h*pg/mL)

Relative BA (5)

Device Performance

• Two versions of the RaniPill capsule were used during Study Part 1:

Version C, which was used in our prior Phase 1 study of octreotide (which also utilized a Version A and Version B);

and Version D, the latest iteration of the RaniPill capsule.

• RaniPill Version D demonstrated a higher drug delivery success rate than Version C:

o 95% (20/21) of participants received successful drug delivery when ingesting RaniPill Version D.

o 75% (6/8) of participants received successful drug delivery when ingesting RaniPill Version C.

The device performance analysis does not include participants excluded from the study per protocol, as drug delivery was not measured in such participants.

Study Part 2 - Topline Results

Study Part 2 was a continuation of Rani’s single-center, open-label Phase 1 study of RT-102 conducted in Australia.

The study evaluated the safety and tolerability of once-daily administration of RT-102 containing 20 μg of PTH given repeatedly for seven consecutive days in ten healthy female volunteers (five of whom were post-menopausal).

Complete pharmacokinetic profiles of PTH were obtained for each subject on Day 7.

• RT-102 was generally well tolerated, with no serious adverse events noted during the study

o None of the participants withdrew from the repeat-dose study due to any adverse event related to the RaniPill capsule or due to difficulty swallowing the capsule

o Two subjects had transient, mild-to-moderate adverse events which resolved without any intervention

• Device remnants were excreted without sequelae in all subjects

Pharmacokinetics

• RT-102 delivered 20 µg of PTH with high bioavailability (relative to 20 µg SC Forteo (teriparatide) in Study Part 1, confirming the high bioavailability of PTH delivered via the RaniPill capsule observed during Study Part 1.

Device Performance

• In all ten participants who completed seven days of daily, consecutive dosing, the RaniPill capsule demonstrated an overall drug delivery success rate of 91% over the seven days (drug sampling was done at three, six and nine hours after capsule swallowing on Days 1-6).

• On Day 7, with more frequent, serial drug sampling after capsule swallowing on that day, the drug delivery success rate was 100%.

• On Days 1 through 6, participants ate food three hours after administration of the RaniPill capsule.

The number of successful deployments was comparable before and after food was consumed.

We have completed a pre-IND meeting with the FDA with respect to RT-102.

Following feedback from the meeting, we believe that a 505(b)(2) pathway is suitable for the development of RT-102 in the U.S.

In addition, we obtained guidance from the FDA on our preclinical and clinical development plans for RT-102.

The next step for this program is to initiate a Phase 2 clinical trial of RT-102.

Anti-TNF-alpha antibody for the treatment of rheumatoid arthritis

Market overview

Anti-TNF-alpha antibodies such as adalimumab are used to treat a range of inflammatory disorders and are among the largest selling class of pharmaceutical drugs globally as measured by revenue.

Adalimumab, sold by AbbVie Inc.

under the brand name Humira, generated U.S.

sales of approximately $7.14 billion in 2024.

Adalimumab is approved by the FDA and EMA to treat a range of autoimmune conditions, including rheumatoid arthritis, psoriasis and Crohn’s disease.

alone, there are an estimated one and one-half million patients with rheumatoid arthritis, seven million with psoriasis, and three million with Crohn’s disease or ulcerative colitis.

At least eight Humira® biosimilars have entered the U.S.

market including Yuflyma®, a high-concentration, citrate-free adalimumab biosimilar marketed by Celltrion.

Patients who use adalimumab administer the drug through a subcutaneous injection once every two weeks.

Despite the painful injections required to administer it, adalimumab was the best-selling drug globally in 2020.

Our solution:

We believe that the development of an orally administered anti-TNF-alpha antibody represents a significant market opportunity.

In June 2023, we entered into a License and Supply Agreement with Celltrion under which we receive an exclusive license and supply of Celltrion’s adalimumab biosimilar for development and commercialization of RT-105 worldwide, subject to a right of first negotiation for Celltrion.

Preclinical studies

The PK profile for RT-105 was comparable to the profile for subcutaneous administration, and mean bioavailability for RT-105 was 49%, compared to 46% with subcutaneous injection.

Clinical trials

Endoscopic administration of adalimumab into the jejunum of healthy human volunteers

To assess whether the observations from preclinical studies regarding absorption of adalimumab through the intestinal wall translate to clinical trials, we conducted an endoscopic study in humans.

Blood samples were obtained at prescribed intervals during a 14-day study period.

PK profiles were similar with no notable differences observed in either area under the curve (“AUC”) or maximum serum concentration (“Cmax”).

The mean AUC was 62.7 ± 11.4 µg/ml*day*kg/mg for the subcutaneous group and 45.0 ± 29.0 µg/ml*day*kg/mg for the intrajejunal group.

No serious adverse events were noted in this study, and adverse events of headache and flu-like symptoms after intrajejunal administration resolved within 48 hours.

The results are consistent with data obtained in preclinical studies, confirming intrajejunal delivery as a viable route of delivery for adalimumab.

In November 2023, we announced the pausing of development of RT-105 as part of a strategic focusing of the business.

The next milestone for this program will be to initiate a Phase 1 clinical trial of RT-105.

Under the Celltrion Agreement for adalimumab, Celltrion will have a right to terminate the agreement if we do not initiate a Phase 1 clinical trial with RT-105, or fail to deliver to Celltrion topline data from a Phase 1 trial that meets its primary endpoint(s), within certain agreed time periods.

The next step for this program is to advance clinical development of RT-111 with the RaniPill HC.

Undisclosed compound for rare disease

In October 2025, we entered into the Chugai Collaboration and License Agreement with Chugai to develop, manufacture, seek regulatory approvals for and, if approved, commercialize the Chugai Product (RT-117) combining Chugai’s Compound, which is in development for hemophilia, and the RaniPill HC oral delivery device for use in humans.

Discontinuation of RT-102 and RT-110

In 2026, as part of a strategic prioritization of our pipeline, we made the decision to discontinue development of our two endocrinology programs:

RT-102 (a RaniPill GO capsule containing parathyroid hormone for the treatment of osteoporosis) and RT-110 (a RaniPill GO capsule containing parathyroid hormone for the treatment of hypo-parathyroidism).

RT-102 had generated encouraging Phase 1 data, including a single-ascending dose portion (“Study Part 1”) that met all of its endpoints and a seven-day repeat-dose portion (“Study Part 2”) that was generally well tolerated, with no serious adverse events.

However, following a thorough review of the clinical and commercial landscape, we concluded that advancing RT-102 to Phase 2 would require resources that we believe are better deployed in support of RT-114 and our other product candidates, which we believe have greater near-term commercial potential.

RT-110 was previously paused as part of a strategic focusing of our business in November 2023.

This decision reflects our assessment that our obesity, immunology, and partner programs represent a more compelling near-term commercial and clinical opportunity given market dynamics and competitive landscape.

We also believe this prioritization is in the best long-term interest of our shareholders.

We retain rights to both programs and may explore partnership opportunities in the future, though we have no current plans to resume development of either program.

The Market and Our Strategy

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Chronic conditions, including obesity, autoimmune diseases, metabolic disorders, cancers, and cardiovascular diseases are increasingly being treated with biologics.

In 2023, eight of the ten highest revenue-producing drugs in the world were biologics.

Based on 2025 data from Drug Discovery & Development®, approximately eight of the ten highest revenue-producing drugs in the world were biologics.

Current treatments using biologics are primarily via injections.

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We continue to develop the RaniPill HC, a high-capacity RaniPill capsule designed to deliver drug payloads up to 200µL.

As of January 1, 2025, we had tested more than 350 RaniPill HC devices in vivo including delivery of multiple different antibodies and peptides.

We intend to initiate clinical testing of the RaniPill HC in mid-2025.

In March 2025, we announced preclinical data demonstrating bioequivalence of RT-114, a GLP-1/GLP-2 dual agonist (PG-102) delivered orally via the RaniPill HC, to subcutaneously administered PG-102.

RT-114 yielded a relative bioavailability of 111% compared to PG-102 delivered subcutaneously with comparable pharmacokinetic profiles and weight loss.

The RaniPill capsule was well tolerated with no changes in drug-related safety profile compared to subcutaneous delivery and was excreted without sequelae in all canines.

RT-114 achieved a 90% delivery success rate (9 out of 10 canines).

For information regarding the preclinical study and the RT-114 program, see the section titled “Our Pipeline Programs - RT-114:

GLP-1/GLP-2 dual agonist for the treatment of obesity” for more information.”

Semaglutide Study

In February 2025, we announced results from a nonclinical pharmacokinetic and pharmacodynamic study of the GLP-1 agonist semaglutide administered via the RaniPill HC.

The nonclinical pharmacokinetic and pharmacodynamic study was conducted to examine the effects of semaglutide delivered orally via the RaniPill (RT-116) versus a subcutaneous injection comparator group.

The 2x2 crossover study was conducted in two parts with a period of four weeks separating the two groups to evaluate the PK, PD and safety of RT-116.

Eight canines were randomized into two groups who received 0.5mg of semaglutide delivered via oral administration of the RaniPill HC (N=4) or subcutaneous injection (N=4).

Endpoints included plasma drug concentrations, body weight, food intake, lipid profile, and safety.

Data Highlights

Semaglutide was successfully delivered in 7 of 8 canines that received the RaniPill capsule.

Semaglutide administered via the RaniPill capsule was well tolerated with no serious adverse events.

Cmax, Tmax, and AUC were comparable for semglutide administered via RaniPill capsule and subcutaneous administration of semaglutide.

Oral administration via the RaniPill capsule demonstrated bioavailability and biological activity comparable to subcutaneous administration.

The relative bioavailability of oral semaglutide was 107% versus subcutaneous administration.

Both groups saw comparable weight loss which appeared to be driven by decreased food intake that coincided with rises in plasma drug levels thus indicating there is a PD effect to treatment.

Both groups saw comparable moderate decreases in serum triglycerides and cholesterol.

As of January 1, 2026, we had tested more than 350 RaniPill HC devices in vivo including delivery of multiple different antibodies and peptides, including multiple animal studies with pharmacodynamic endpoints.

In December 2025, we initiated a clinical trial with RT-114, a RaniPill HC capsule containing a GLP-1/GLP-2 dual agonist (PG-102), for the treatment of obesity.

Chugai Research Agreement

In May 2025, we announced that we entered the Chugai Research Agreement in August 2024 for two molecules with undisclosed targets provided by Chugai.

The full analysis confirmed the RaniPill HC delivery demonstrated comparable bioavailability to the subcutaneous route of delivery for both molecules studied.

Previous Studies

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In one study, we tracked the serum concentrations of adalimumab, following the oral administration of the enteric-coated RaniPill HC capsule containing 11mg of Humira (adalimumab) to four canine models.

In the second study, we tracked the serum concentrations of

dupilumab, following the oral administration of the enteric-coated RaniPill HC capsule containing 16.5mg of dupilumab to six canine models.

In the second study, we tracked the serum concentrations of dupilumab, following the oral administration of the enteric-coated RaniPill HC capsule containing 16.5mg of dupilumab to six canine models.

In both studies, the RaniPill HC was well tolerated, all animals remained healthy throughout the study period with no clinical findings or adverse events, and all device remnants were excreted normally without sequelae.

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60-Day GLP Study

We conducted a preclinical GLP study evaluating the safety and tolerability of the RaniPill drug delivery platform, following 60-day repeat oral administration of the test article, RT-100, in healthy animals.

In October 2023, we conducted a preclinical GLP study evaluating the safety and tolerability of the RaniPill drug delivery platform, following 60-day repeat oral administration of the test article, RT-100, in healthy animals.

RT-100 is an enteric-coated capsule identical to RT-102, but instead of PTH contained the pharmaceutical excipient mannitol.

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We have completed a pre-IND meeting with the FDA with respect to RT-102.

Following feedback from the meeting, we believe that a 505(b)(2) pathway is suitable for the development of RT-102 in the U.S.

Following feedback from the meeting, we believe that a 505(b)(2) pathway is suitable for development of RT-102 in the U.S.

The regulatory development pathway for each of our product candidates is dependent on the molecule being delivered and therefore may be different than the pathway for RT-102.

CBER and CDER may ask for additional testing for specific biologics, disease indications, or patient populations.

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License and Evaluation Agreements

Chugai Pharmaceutical Co., Ltd.

In October 2025, we entered into the Chugai Collaboration and License Agreement with Chugai to develop, manufacture, seek regulatory approvals for and, if approved, commercialize the Chugai Product combining Chugai’s Compound, which is in development for hemophilia, and the RaniPill HC oral delivery device for use in humans.

In accordance with a development plan, the parties have allocated responsibility for the development of the Chugai Product worldwide, with Chugai leading and having sole responsibility for clinical, regulatory, and commercial activities.

The parties will allocate preclinical, Chemistry Manufacturing and Controls, and manufacturing and supply activities between each other.

Chugai is primarily responsible for preclinical development, and for the manufacturing and supply of the Compound.

Rani is primarily responsible for seeking positive regulatory feedback related to the sterility of the microneedle used in the RaniPill, providing regulatory support to Chugai when requested, performing Chemistry Manufacturing and Controls activities related to the RaniPill and manufacturing and supply of the Chugai Product.

Under the Chugai Collaboration and License Agreement, we granted Chugai an exclusive, worldwide right and license to certain intellectual property owned by us to research, develop, register, manufacture, use, sell, offer to sell, import, export, commercialize, and market the Chugai Product.

Chugai granted us a non-exclusive, worldwide right and license to certain intellectual property owned by Chugai to manufacture and supply the RaniPill and Chugai Product to Chugai and to perform our activities under the Chugai Collaboration and License Agreement.

Both parties have the right to sublicense subject to certain conditions.

In addition, Chugai has a one-time limited option to replace the Compound with a different compound subject to certain terms and conditions, a time-limited right of first refusal with respect to a select group of additional targets, and a time-limited option to extend its rights to up to five of the additional drug targets under similar deal terms as the Chugai Collaboration and License Agreement.

ProGen Co., Ltd.

In June 2024, we entered into the ProGen Collaboration Agreement with ProGen.

In June 2024, we entered into a collaboration agreement (the "ProGen Collaboration Agreement") with with ProGen Co.

Under the ProGen Collaboration Agreement, the parties will collaborate to manufacture, develop, seek regulatory approvals for and, if approved, commercialize a product (RT-114) combining ProGen’s GLP-1/GLP-2 dual agonist compound, PG-102, and the RaniPill HC oral delivery device in the field of weight management (including without limitation obesity, weight reduction and weight maintenance) in humans.

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Each party has the right to opt-out of the ProGen Collaboration (“Opt-Out”) at any time upon prior written notice to the other party.

Each party has the right to opt-out of the ProGen Collaboration Agreement (“Opt-Out”) at any time upon prior written notice to the other party.

Following an Opt-Out, the continuing party shall have sole right to develop, conduct regulatory activities for and commercialize RT-114 on a worldwide basis.

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Celltrion will provide, and we will purchase, supply of ustekinumab biosimilar and adalimumab biosimilar at supply prices set forth in the respective Celltrion Agreement.

We will obtain ustekiunmab biosimilar and adalimumab biosimilar exclusively from Celltrion for the manufacture, development and commercialization of RT-111 and RT-105, respectively, subject to a right to obtain supply from alternative sources under certain circumstances where Celltrion experiences supply disruption.

We will obtain ustekinumab biosimilar and adalimumab biosimilar exclusively from Celltrion for the manufacture, development and commercialization of RT-111 and RT-105, respectively, subject to a right to obtain supply from alternative sources under certain circumstances where Celltrion experiences supply disruption.

Under the Celltrion Agreements, we have sole right to manufacture, develop and commercialize RT-111 and RT-105 worldwide, subject to an exclusive right of first negotiation (“ROFN”) granted to Celltrion for each program.

For each program, following our delivery to Celltrion of a data package consisting of topline safety information, pharmacokinetic results and device performance, and the raw data related to topline results from a Phase 1 clinical trial of such program that meets its primary endpoint(s), Celltrion will have 30 days to exercise its ROFN with respect to that program.

If Celltrion timely exercises the ROFN, then Celltrion will have an exclusive period of 90 days to negotiate in good faith a definitive agreement with us for rights to clinically develop and commercialize the applicable program in territories selected by Celltrion.

In the event Celltrion does not timely exercise the ROFN or Celltrion notifies us that it does not intend to exercise the ROFN or, after timely exercising the ROFN, notifies us that Celltrion withdraws its exercise of the ROFN, or the parties fail to enter into a definitive agreement for the development and commercialization of the applicable program within the exclusive negotiation period, then the ROFN regarding that program will terminate and we will have no further obligations under the Celltrion Agreements related to a ROFN for that program.

The ROFN with respect to RT-111 has expired.

The ROFN with respect to RT-111 has expired and we have not yet initiated a Phase 1 clinical trial with respect to RT-105.

The Celltrion Agreements allocate rights between the parties with respect to inventions generated in performance of the agreement for the manufacture, development and commercialization of each of RT-111 and RT-105, respectively.

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Celltrion has a right to terminate each agreement if we do not achieve certain development milestones with respect to that agreement, and each party has certain rights to terminate the applicable agreement for material breach or safety concerns regarding the ustekinumab biosimilar or RT-111, or adalimumab biosimilar or RT-105, respectively.

Celltrion currently has a right to terminate the Adalimumab Celltrion Agreement because we did not initiate a Phase 1 clinical trial within a certain period specified in the Adalimumab Celltrion Agreement.

Evaluation agreement

In August 2024, we entered into a contract to conduct evaluation services of certain customer compounds for oral delivery using the RaniPill HC.

This customer paid us an up-front payment of $0.6 million upon execution of the contract.

Upon completion of the evaluation services, we are entitled to a final $0.6 million payment for an aggregate total of $1.2 million due under the contract.

In addition, if agreed upon, the agreement allows for joint filing of certain intellectual property protection in which all associated expenses will be shared equally.

The customer has the ability to terminate the agreement at any time by providing 10 days’ written notice after the effective date of the contract.

The contract can be terminated for cause by either party based on uncured material breach by the other party.

Upon early termination, all ongoing activities under the agreement and all mutual collaboration, development and commercialization licenses and sublicenses will terminate.

In August 2024, we entered into the Chugai Research Agreement with Chugai to conduct evaluation services of certain Chugai compounds for oral delivery using the RaniPill HC, which was concluded to be a single performance obligation with an enforceable right to payment.

Chugai paid us an up-front payment of $0.6 million upon execution of the Chugai Research Agreement.

Upon completion of the evaluation services, in April 2025, we were paid a final $0.6 million for an aggregate total of $1.2 million due under the Chugai Research Agreement.

In May 2025, we publicly announced the Chugai Research Agreement and that the full analysis confirmed the RaniPill HC delivery demonstrated comparable bioavailability to the subcutaneous route of delivery for both molecules studied.

Manufacturing and Quality Assurance

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government, state legislatures, and foreign governments have continued implementing cost-containment programs, including price controls, restrictions on coverage and reimbursement, and requirements for substitution of generic products when available.

For example, the U.S.

Department of Health and Human Services (“HHS”) imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis.

HHS has also been empowered to negotiate the price of certain single-source biologics that have been on the market for at least eleven (11) years covered under Medicare as part of the Medicare Drug Price Negotiation Program.

Each year up to twenty (20) products will be selected by HHS for the Medicare Drug Price Negotiation Program.

Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis.

Third-party payors are increasingly challenging prices charged, examining medical necessity, and reviewing cost effectiveness in addition to questioning safety and efficacy.

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Early-stage device-based technologies such as the SOMA and LUMI from the Novo Nordisk-MIT collaboration were reported to be in early clinical and preclinical stages, respectively.

Two other companies pursuing a device-based approach are Biograil ApS and Biora Therapeutics, Inc., both of which were reported to be in a preclinical stage of development.

Three other companies pursuing a device-based approach are Biograil ApS, Biora Therapeutics, Inc., and Alma Therapeutics, all of which were reported to be in a preclinical stage of development.

In December 2024, Biora announced that it is undertaking a Chapter 11 sale process.

Chemistry-based oral delivery companies include, but are not limited to, Oramed Pharmaceuticals, Inc., Entera Bio Ltd., Protagonist Therapeutics, Inc., i2O Therapeutics, Intract Pharma, and two with recently approved oral peptide products – Mycapssa from Chiesi Farmaceutici SpA and Rybelsus from Novo Nordisk A/S.

After the sale process concluded in May 2025, the bankruptcy case converted from Chapter 11 to Chapter 7, indicating a liquidation of Biora’s remaining assets.

Chemistry-based oral delivery companies include, but are not limited to, Oramed Pharmaceuticals, Inc., Entera Bio Ltd., Protagonist Therapeutics, Inc., Intract Pharma, Eli Lilly and Company, and three with recently approved oral peptide products – Mycapssa from Chiesi Farmaceutici SpA and oral Wegovy and Rybelsus from Novo Nordisk A/S.

Chemistry-based approaches have limited applications because they work only for small peptides and, even then, with low (often less than 1%) bioavailability, far lower than injections.

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For information regarding the risks related to our intellectual property, see the section titled “Risk Factors— Risks Related to Our Intellectual Property.”

Exclusive License Agreement

In June 2021, we entered into an Amended and Restated Exclusive License Agreement with InCube Labs, LLC (“ICL”), which replaced the 2012 Exclusive License Agreement between ICL and Rani LLC, as amended in 2013, and terminated the 2012 Intellectual Property Agreement between ICL and Rani LLC, as amended in June 2013.

Under the Amended and Restated Exclusive License Agreement, we had a fully paid, exclusive license under certain scheduled patents related to optional features of the device and certain other scheduled patents to exploit products covered by those patents in the field of oral delivery of sensors, small molecule drugs or biologic drugs including, any peptide, antibody, protein, cell therapy, gene therapy or vaccine.

We were allowed to terminate the Amended and Restated Exclusive License Agreement in its entirety or as to any particular licensed patent upon notification to ICL of such intent to terminate.

In November 2025, as part of a strategic focusing of our resources, we notified ICL that we are terminating the Amended and Restated Exclusive License Agreement in its entirety.

The termination became effective on January 18, 2026, and we no longer have any obligations to ICL under the Amended and Restated Exclusive License Agreement.

We have built a patent portfolio globally around several aspects of the current and future generations of our technology.

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This patent family claims many device aspects of the RaniPill platform, including aspects of the RaniPill GO and certain aspects of the RaniPill HC, and the delivery of a wide variety of biologics using the RaniPill platform.

As of January 1, 2025, this patent family included patents issued in the United States and patents issued in other jurisdictions (in Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, India, Ireland, Italy, Japan, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and the United Kingdom), with applications pending in the United States, Australia, Canada, China, Europe, Hong Kong, and Japan.

As of January 1, 2026, this patent family included patents issued in the United States and in other jurisdictions (in Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and the United Kingdom), with applications pending in the United States, Australia, Canada, China, Europe, Hong Kong, and Japan.

We also own several patent families directed to the RaniPill HC.

These patent families have priority dates in 2020, 2022, 2023, 2024, and 2025, with patent term expected to extend into at least 2046 if all fees are paid.

As of January 1, 2026, this patent family included a patent granted in Japan and applications pending in the United States, the international PCT stage, and other jurisdictions (in Australia, Brazil, Canada, China, Europe, Japan, Israel, South Korea, and Mexico).

These patent families include claims directed to device aspects, devices containing specific biologics, methods of preparing such devices, and methods of delivering a wide variety of biologics using the RaniPill HC.

Our microtablet patent family includes claims covering the microtablets delivered by the RaniPill GO.

This patent family has a priority date in 2014, includes several dozen granted patents and pending patent applications, and is expected to have patent terms extending into at least 2035 if all fees are paid.

As of January 1, 2025, this patent family included patents issued in the United States and other jurisdictions (i.e., Australia, Canada, China, India and Japan), with applications pending in the United States, Australia, Canada, China, Europe, and Japan.

We own numerous additional patents and patent applications, with claims to additional biologics, pharmacologic properties of various biologics and other ingestible device technologies, with applications pending in the United States, Australia, Brazil, Canada, China, Europe, Hong Kong, India, Japan, Mexico, and South Korea.

This patent family has a priority date in 2014, and is expected to have patent terms extending into at least 2035 if all fees are paid.

As of January 1, 2026, this patent family included patents issued in the United States and other jurisdictions (i.e., Australia, Canada, China, and Japan), with applications pending in the United States, China, and Japan.

We own numerous additional patents and patent applications, with claims to additional biologics, pharmacologic properties of various biologics and other ingestible device technologies, with patents granted in the United States, Australia, and Japan, and applications pending in the United States, Australia, Brazil, Canada, China, Europe, Hong Kong, India, Japan, Mexico, and South Korea.

Patents in these families are expected to expire between the late 2030s and mid 2040s if all fees are paid.

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An IRB is charged with protecting the welfare and rights of trial participants and considers such items as whether the risks to individuals participating in the clinical trials are minimized and are reasonable in relation to anticipated benefits.

Regulatory authorities, the IRB, or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk, the trial is not being performed in accordance with the investigational plan or associated protocols, or that the trial is unlikely to meet its stated objectives.

Regulatory authorities, the IRB, or the sponsor may suspend a clinical trial at any time

on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk, the trial is not being performed in accordance with the investigational plan or associated protocols, or that the trial is unlikely to meet its stated objectives.

Some studies also include oversight by an independent group of qualified experts organized by the clinical trial sponsor, known as a data safety monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on access to certain data from the study and may halt the clinical trial if the data safety monitoring board determines that there is an unacceptable safety risk for subjects, no demonstration of efficacy, or other grounds.

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The FDA also may audit data from clinical trials to ensure compliance with GCP requirements.

Additionally, the FDA may refer applications for novel drug products or drug products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation, and a recommendation as to whether the application should be approved and under what conditions, if any.

for review, evaluation, and a recommendation as to whether the application should be approved and under what conditions, if any.

The FDA is not bound by recommendations of an advisory committee, but it considers such recommendations when making decisions on approval.

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The FDA and the sponsor must reach agreement on the PSP.

A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric

plan need to be considered based on data collected from nonclinical studies, early phase clinical trials, and/or other clinical development programs.

A sponsor can submit amendments to an agreed-upon initial PSP at any time if changes to the pediatric plan need to be considered based on data collected from nonclinical studies, early phase clinical trials, and/or other clinical development programs.

The FDA may, on its own initiative or at the request of the applicant, grant deferrals for submission of data or full or partial waivers.

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• Products intended to treat serious or life threatening diseases or conditions may be eligible for accelerated approval upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, has an effect on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, or that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account severity, rarity, or prevalence of the condition and the availability or lack of alternative treatments.

As a condition of approval, the FDA may require that a sponsor of a product receiving accelerated approval perform adequate and well-controlled post-marketing clinical trials.

As a condition of approval, the FDA may require that a sponsor of a product receiving accelerated approval perform adequate and well-controlled

post-marketing clinical trials.

In addition, the FDA currently requires pre-approval of promotional materials as a condition for accelerated approval, which could adversely impact the timing of the commercial launch of the product.

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We are responsible for the selection and monitoring of qualified contract manufacturers, laboratories, and packagers, and, in certain circumstances, qualified suppliers to them.

These facilities and, where applicable, their suppliers are subject to inspections by the FDA at any time,

and the discovery of violative conditions, including failure to conform to cGMP, could result in enforcement actions that interrupt the operation of any such facilities or the ability to distribute products manufactured, processed, or tested by them.

These facilities and, where applicable, their suppliers are subject to inspections by the FDA at any time, and the discovery of violative conditions, including failure to conform to cGMP, could result in enforcement actions that interrupt the operation of any such facilities or the ability to distribute products manufactured, processed, or tested by them.

Accordingly, we must continue to expend time, money, and effort on quality control for our own facilities and the facilities of others which contribute to the commercialization of our final product, to maintain compliance with cGMP and other aspects of regulatory compliance.

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state and foreign law equivalents of each of the above federal laws, which, in some cases, differ from each other in significant ways, and may not have the same effect, complicating compliance efforts.

Additionally, some state and local laws require certain regulatory licenses to manufacture or distribute our products commercially and/or the registration of pharmaceutical sales representatives in the jurisdiction.

If our operations are found to be in violation of any of such laws or any other governmental regulations that apply, we may be subject to penalties including, without limitation, significant civil, criminal, and administrative penalties, damages, fines, exclusion from participating in government-funded healthcare programs such as Medicare and Medicaid or similar programs in other countries or jurisdictions, government investigations, consent decrees, corporate integrity agreements, integrity oversight and reporting obligations to resolve allegations of non-compliance, disgorgement, imprisonment, contractual damages, reputational harm, diminished profits and market share, and the curtailment or restructuring of our operations.

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In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by federal and state legislative initiatives, including those designed to limit the pricing, coverage, and reimbursement of pharmaceutical and biopharmaceutical products, especially under government-funded health care programs, and increased governmental control of drug pricing.

For example, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “ACA”), which was enacted in March 2010, contains a number of provisions of particular import to the pharmaceutical and biotechnology industries, including, but not limited to, those governing enrollment in federal healthcare programs, a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated, and annual fees based on pharmaceutical companies’ share of sales to federal health care programs.

There have been executive, judicial and Congressional challenges and amendments to certain aspects of the ACA.

For example, on August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in Affordable Care Act marketplaces through plan year 2025.

The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and through a newly established manufacturer discount program.

It is possible that the ACA will be subject to additional challenges in the future.

It is unclear how such challenges and the healthcare reform measures of the second Trump administration will impact the ACA, or the impact any changes to the ACA may have on our ability to commercialize products or the prices we are able to obtain.

Since its enactment, there have been amendments and judicial, Congressional and executive branch challenges to certain aspects of the ACA.

For example, on July 4, 2025, the One Big Beautiful Bill Act (the “OBBBA”) was signed into law, which narrowed access to ACA marketplace exchange enrollment and declined to extend the ACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance.

The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program.

Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies.

In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted.

These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year pursuant to the Budget Control Act of 2011, which began in April 2013 and, due to subsequent legislative amendments to the statute, including the Infrastructure Investment and Jobs Act, will remain in effect until 2032 unless additional Congressional action is taken.

In addition, recently there has been heightened governmental scrutiny over the manner in which drug manufacturers set prices for their commercial products.

At the federal level, the IRA, among other things, (i) directs the U.S.

Department of Health and Human Services (“HHS”) to negotiate the price of certain high-expenditure single-source biologics that have been on the market for at least 11 years covered under Medicare (the “Medicare Drug Price Negotiation Program”) and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation.

These provisions began to take effect progressively starting in fiscal year 2023.

On August 15, 2024, HHS announced the agreed-upon prices of the first ten drugs that were subject to price negotiations, although the Medicare

Drug Price Negotiation Program is currently subject to legal challenges.

On January 17, 2025, HHS selected fifteen additional products covered under Part D for price negotiation in 2024.

Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program.

Further, on December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights.

While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework.

Individual states in the United States have also become increasingly aggressive in passing legislation and implementing regulations designed to control drug pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures.

The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates, if approved.

At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Additional health reform measures may continue and affect our business in unknown ways, particularly given the recent change in administration.

The current Trump administration is pursuing policies to reduce regulations and expenditures across government including at HHS, the FDA, CMS and related agencies.

These changes include aggregate reductions to Medicare payments to providers of 2% per fiscal year, which began in 2013 and will remain in effect until 2032 unless additional Congressional action is taken.

The current administration is pursuing policies to reduce regulations and expenditures across government agencies including at HHS, the FDA, CMS and related agencies.

These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business.

These actions may include, for example, directives to reduce agency workforce, rescinding a Biden administration executive order tasking the Center for Medicare and Medicaid Innovation to consider new payment and healthcare models to limit drug spending and eliminating the Biden administration’s executive order that directed HHS to establishing an artificial intelligence (“AI”) task force and developing a strategic plan, and directing certain federal agencies to enforce existing law regarding hospital and price plan transparency and by standardizing prices across hospitals and health plans.

Additionally, in its June 2024 decision in Loper Bright Enterprises v.

Raimondo, the U.S.

Supreme Court overturned the longstanding Chevron doctrine, under which courts were required to give deference to regulatory agencies’ reasonable interpretations of ambiguous federal statutes.

The Loper Bright decision could result in additional legal challenges to current regulations and guidance issued by federal agencies applicable to our operations, including those issued by the FDA.

Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program created under the IRA.

For example, the current administration has announced agreements with several pharmaceutical companies that require the drug manufacturers to offer, through a direct to consumer platform (“TrumpRx”) U.S.

patients and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues.

Other recent actions, for example, include (1) directing agencies to reduce agency workforce and cut programs;

(2) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives;

(3) imposing tariffs on imported pharmaceutical products;

and (4) as part of the Make America Healthy Again Commission’s Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising.

Additionally, the current administration recently called on Congress to enact "The Great Healthcare Plan," to codify and expand Most-Favored Nation pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions on pharmacy benefit manager payment methodologies, among other things.

These actions and policies may significantly reduce U.S.

drug prices, potentially impacting manufacturers’ global pricing strategies and profitability, while increasing their operational costs and compliance risks.

In June 2024, the U.S.

Supreme Court’s Loper Bright decision greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations.

Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

Data privacy and security obligations

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Obligations related to the processing of personal data worldwide is rapidly evolving.

The number and scope of data privacy and security laws, regulations and other obligations is changing, subject to differing applications and interpretations, and may be inconsistent among jurisdictions, or in conflict with other data processing obligations.

The number and scope of data privacy and security laws, regulations and other obligations are changing, subject to differing applications and interpretations, and may be inconsistent among

jurisdictions, or in conflict with other data processing obligations.

Efforts to ensure that our current and future business operations and arrangements, including our relationship with our CROs, other vendors who process data on our behalf, and other third parties with whom we work comply with applicable data privacy and security obligations involve substantial costs.

As of December 31, 2024, we had 105 full-time employees and one part-time employee.

As of December 31, 2025, we had 69 full-time employees and two part-time employees.

The majority of our employees are based at our facilities in San Jose and Fremont, California, with a contingent of employees based outside of California.

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• Amended and restated Rani LLC’s operating agreement (the “Rani LLC Agreement”) to appoint Rani Holdings as the sole managing member of Rani LLC and effectuated an exchange of all outstanding interests in Rani LLC into Class A Units and an equal number of voting noneconomic Class B units.

• Amended and restated our certificate of incorporation to provide for the issuance of (i) Class A common stock, each share of which entitles its holders to one vote per share, (ii) Class B common stock, each share of which entitles its holders to ten votes per share on all matters presented to the Company's stockholders, (iii) Class C common stock, which has no voting rights, except as otherwise required by law and (iv) preferred stock.

• Amended and restated our certificate of incorporation to provide for the issuance of (i) Class A common stock, each share of which entitles its holders to one vote per share, (ii) Class B common stock, each share of which entitles its holders to ten votes per share on all matters presented to our stockholders, (iii) Class C common stock, which has no voting rights, except as otherwise required by law and (iv) preferred stock.

• Certain holders of Class A Units tendered their Class A Units for shares of our Class A common stock.

Certain holders of Class A Units continued to hold such Class A Units (“Continuing LLC Owners”) and received shares of our Class B common stock.

• Continuing LLC Owners are entitled to exchange, subject to the terms of the Rani LLC Agreement, the Class A Units they hold in Rani LLC, together with the shares they hold of our Class B common stock (together referred to as a "Paired Interest"), in return for shares of the Company’s Class A common stock on a one-for-one basis provided that, at our election, we may effect a direct exchange of such Class A common stock or make a cash payment equal to a volume weighted average market price of one share of Class A common stock for each Paired Interest redeemed.

• Continuing LLC Owners are entitled to exchange, subject to the terms of the Rani LLC Agreement, the Class A Units they hold in Rani LLC, together with the shares they hold of our Class B common stock (together referred to as a "Paired Interest"), in return for shares of our Class A common stock on a one-for-one basis provided that, at our election, we may effect a direct exchange of such Class A common stock or make a cash payment equal to a volume weighted average market price of one share of Class A common stock for each Paired Interest redeemed.

Any shares of Class B common stock will be canceled on a one-for-one basis if we, at the election of the Continuing LLC Owners, redeem or exchange such Paired Interest pursuant to the terms of the Rani LLC Agreement.

• Entered into a registration rights agreement and tax receivable agreement (“Tax Receivable Agreement” or “TRA”) with certain of the Continuing LLC Owners.

In connection with the Private Placement, we implemented certain governance changes, including the following amendments to our organizational documents and the termination of certain existing agreements:

Termination of Tax Receivable Agreement

As contemplated by the Private Placement, on December 31, 2025, we entered into a Tax Receivable Agreement Termination and Release Agreement (the “TRA Termination Agreement”) by and between us and InCube Labs, LLC (acting on behalf of all the TRA Parties (as defined therein)), pursuant to which the parties agreed to terminate that certain Tax Receivable Agreement, dated August 3, 2021 (the “TRA”) and disclaim any rights or interests thereunder.

As a result of the termination, we have no further obligations under the TRA, and no tax benefit payments or early termination payments were required in connection

with such termination.

The TRA Termination Agreement provides for the mutual release of the parties from all obligations under the TRA, effective as of December 31, 2025.

Amendment to Certificate of Incorporation

In connection with the governance changes contemplated by the Private Placement, on December 31, 2025, we filed the Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware (the "Restated Charter"), which became effective upon such filing.

As contemplated thereby, the Restated Charter, among other things, provides for:

• Reducing the number of votes to which each share of Class B Common Stock is entitled from ten (10) votes to one (1) vote;

• Elimination of separate vote of Class B Common Stock in certain circumstances;

• Opting to be subject to subject to Section 203 of the Delaware General Corporation Law (the “DGCL”);

• Requiring affirmative vote of the holders of at least two-thirds (2/3) of our outstanding voting power of the outstanding shares of Class A Common Stock and Class B Common Stock to amend or repeal the amended and restated bylaws and certain provisions of the Restated Charter;

eliminating ability of stockholders to call a special meeting of stockholders or fill vacancies on the board of directors;

• Eliminating the ability of our stockholders to act by written consent;

• Eliminating the provisions related to classified board of directors.

Amendment to Bylaws

In connection with the adoption of the Restated Charter, on December 31, 2025, we also adopted Amended and Restated Bylaws (the “Bylaws”), which became effective on such date.

The Bylaws were adopted to reflect conforming changes resulting from the adoption of the Restated Charter.

Sixth Amended and Restated LLC Agreement

In connection with the adoption of the Restated Charter, on December 31, 2025, we entered into a Sixth Amended and Restated Limited Liability Company Agreement (the “LLC Agreement”) which became effective as of such date.

The LLC Agreement was amended and restated to reflect conforming changes resulting from the adoption of the Restated Charter.

Corporate Information

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business