Executive Summary / Key Takeaways

• Rani Therapeutics is pioneering the oral delivery of biologics through its proprietary RaniPill platform, aiming to replace painful injections across high-value therapeutic areas like obesity and immunology.
• The company's RaniPill technology, including the high-capacity RaniPill HC, has demonstrated impressive bioavailability (e.g., 84% for RT-111, 111% for RT-114, 107% for RT-116) and a strong safety profile in preclinical and clinical studies, validating its potential to transform drug administration.
• Recent strategic advancements, including a co-development agreement for RT-114 (GLP-1/GLP-2 dual agonist) with ProGen Co., Ltd. and a significant collaboration with Chugai Pharmaceutical Co. (up to $1.085 billion), underscore growing external validation and provide substantial non-dilutive funding.
• A pivotal oversubscribed private placement in October 2025, raising approximately $60.3 million and converting $6 million of debt, has significantly strengthened Rani's financial position, extending its operational runway into 2028 and alleviating prior going concern doubts.
• Rani's focus on differentiated product profiles, such as once-weekly oral GLP-1/GLP-2 and semaglutide, positions it to capture significant market share in the rapidly expanding obesity market, which is projected to reach $100 billion by 2030.

The Dawn of Oral Biologics: Rani's Disruptive Platform

Rani Therapeutics Holdings, Inc. is at the forefront of a potential paradigm shift in drug delivery, dedicated to eliminating painful injections for millions of patients suffering from chronic conditions. The company's core innovation, the RaniPill capsule, represents a drug-agnostic oral delivery platform designed to administer a wide array of biologics and drugs, including antibodies, proteins, peptides, and oligonucleotides, with bioavailability comparable to subcutaneous injections. This technology addresses a significant unmet need, as patient preference overwhelmingly favors oral medications over injections, even for infrequent regimens. For instance, surveys indicate 76% of patients prefer a daily pill over a once-every-six-months injection, and 88% prefer a daily pill over bi-weekly injections.

The RaniPill platform operates through a sophisticated mechanism: a proprietary enteric coating allows the capsule to safely traverse the acidic stomach environment. Once in the small intestine, the higher pH level triggers the breakdown of the coating and outer shell, exposing a self-inflating balloon. This balloon creates the necessary pressure to inject a dissolvable microneedle, delivering the drug via a transenteric, painless injection directly into the vascular system for rapid absorption. This innovative approach has been extensively tested and clinically validated, demonstrating consistency across numerous preclinical and clinical trials.

Rani's technological prowess is further enhanced by two distinct configurations: the RaniPill GO, designed for drug doses up to 3 mg in microtablet form, and the RaniPill HC (High-Capacity), capable of delivering liquid payloads up to 200µL, equating to up to 20 mg per pill. The RaniPill HC, representing a 500% increase in payload capacity over the RaniPill GO, significantly expands the addressable market to include higher-dose biologics such as monoclonal antibodies. Preclinical studies have consistently shown high bioavailability for 19 molecules, including antibodies, peptides, and large proteins, with a 60-day repeat administration GLP study demonstrating excellent tolerability and no serious adverse events. In clinical trials, over 200 RaniPills have been administered to 146 subjects across three Phase 1 studies, consistently showing good tolerability and no serious adverse events. The company's vertically integrated manufacturing strategy, including investments in automation, aims to achieve a cost of goods (COGS) target competitive with injectables, with a goal of scaling production to 50,000-100,000 pills per day per line for commercialization.

Strategic Pipeline Advancement and High-Impact Partnerships

Rani's strategic narrative is deeply intertwined with its robust pipeline and a series of high-impact collaborations that validate its platform and accelerate its path to market. The company has strategically prioritized the rapidly expanding obesity market, projected to reach $100 billion by 2030, where oral alternatives could fundamentally redefine treatment paradigms.

A cornerstone of this strategy is RT-114, a GLP-1/GLP-2 dual agonist being co-developed and commercialized with ProGen Co., Ltd. Preclinical data for RT-114 demonstrated bioequivalence to subcutaneously administered PG-102, with a relative bioavailability of 111%, a higher Cmax, and an earlier Tmax, alongside comparable weight loss (average peak of 6.7%) but with less variability than subcutaneous dosing. This program aims to offer a differentiated product profile, potentially providing comparable weight loss, a better tolerability profile, and greater preservation of lean muscle mass compared to currently approved products, addressing a critical need highlighted by recent FDA guidance emphasizing body composition in obesity treatments. Furthermore, RT-114's target profile of less frequent, potentially weekly oral dosing contrasts sharply with current oral therapies requiring daily administration, which can burden supply chains and increase costs for peptide-based drugs. Rani plans to initiate a Phase 1 trial for RT-114 by the end of 2025.

Beyond RT-114, Rani has successfully demonstrated the oral delivery of semaglutide (RT-116) via the RaniPill HC in preclinical studies, achieving 107% relative bioavailability compared to subcutaneous semaglutide, with comparable pharmacokinetics and weight loss. While RT-116 is currently a discovery program, its success validates the platform's ability to deliver incretins and opens avenues for future development, potentially in international markets where patent expirations could allow for accelerated market entry.

In immunology, Rani's partnership with Celltrion (CMCSN) for RT-111, an ustekinumab biosimilar, represents a significant clinical breakthrough. Phase 1 results showed high bioavailability (84% compared to subcutaneous ustekinumab) and good tolerability, marking the first clinical evidence of oral delivery of a monoclonal antibody with such high bioavailability. This program exemplifies Rani's "biobetters" strategy, aiming to create novel products from biosimilars by offering differentiated dosing schedules and potentially improved efficacy, rather than merely a price-competitive replacement. The company also has RT-105, an adalimumab biosimilar program utilizing the RaniPill HC, in preclinical development. In endocrinology, RT-102, a parathyroid hormone (PTH) analog for osteoporosis, demonstrated 300-400% higher bioavailability than subcutaneous Forteo in its Phase 1 study, with a 92% delivery success rate. The FDA has indicated a 505(b)(2) pathway is suitable for RT-102, streamlining its regulatory path.

Financial Rejuvenation and Outlook

Historically, Rani Therapeutics has operated as a clinical-stage company, incurring recurring losses and negative cash flows from operations since its inception. For the nine months ended September 30, 2025, the company reported a net loss of $31.88 million and negative cash flows from operations of $19 million, contributing to an accumulated deficit of $122.28 million as of September 30, 2025. These financial factors had previously raised substantial doubt about Rani's ability to continue as a going concern.

However, a series of pivotal financial and strategic developments in October 2025 have fundamentally reshaped Rani's financial outlook. The company secured a significant Collaboration and License Agreement with Chugai Pharmaceutical Co. , potentially valued at up to $1.085 billion, for the development and commercialization of a rare disease antibody using the RaniPill HC device. This collaboration includes a $10 million upfront payment and eligibility for up to $18 million in technology transfer milestones, $57 million in development milestones, $100 million in sales-based milestones, and single-digit royalties on net sales. Concurrently, Rani closed an oversubscribed private placement, raising approximately $60.3 million in gross proceeds, which included the conversion of $6 million of outstanding debt from Avenue Venture Opportunities Fund, L.P. into equity. These combined proceeds, along with the Chugai upfront payment and expected technology transfer milestones, are projected to fund Rani's operations into 2028. This substantial capital infusion has alleviated prior going concern doubts, providing a solid financial foundation for advancing its pipeline.

Operating expenses have seen reductions due to cost containment measures. Research and development expenses decreased by $4.6 million for the nine months ended September 30, 2025, compared to the same period in 2024, primarily due to lower headcount and reduced spending on materials and third-party services. Similarly, general and administrative expenses decreased by $3.8 million over the same period. While Rani expects to continue generating operating losses and negative cash flows for the foreseeable future as it develops the RaniPill capsule, the recent financing and collaborations provide critical runway and validation.

Competitive Landscape and Market Disruption

Rani Therapeutics operates in a competitive biopharmaceutical landscape dominated by large, established players such as Novo Nordisk (NVO), Eli Lilly (LLY), Pfizer (PFE), and Johnson & Johnson (JNJ). These companies possess extensive commercialization experience, broad product portfolios, and robust financial resources. However, Rani's innovative RaniPill platform offers a distinct competitive advantage by addressing the fundamental patient aversion to injections and the limitations of existing oral therapies.

Unlike many current oral treatments for biologics, which often require significantly higher doses or daily administration, Rani's target product profiles for RT-114 and RT-116 aim for less frequent, potentially weekly oral dosing at API quantities similar to injectable products. This positions Rani uniquely against competitors like Novo Nordisk's oral semaglutide (Rybelsus), which requires daily, higher-dose administration for glycemic control, and against the broader market of injectable GLP-1s. The potential for improved tolerability, preservation of lean body mass, and shorter titration schedules with RT-114 further differentiates Rani in the crowded obesity market.

In immunology, where ustekinumab (STELARA) is exclusively an injectable, Rani's RT-111 represents a significant disruption by offering the first orally administered monoclonal antibody with high bioavailability. This directly challenges the current standard of care and positions Rani to capture market share by providing a more convenient option for patients with inflammatory conditions. While large pharmaceutical companies have strong R&D capabilities and global distribution, Rani's specialized oral delivery technology creates a unique competitive moat, potentially leading to improved patient adherence and, ultimately, better treatment outcomes. The strategic partnerships with ProGen Co., Ltd. and Chugai Pharmaceutical Co. further validate Rani's platform and provide access to development expertise and potential commercialization pathways that would be challenging for a clinical-stage company to build independently.

Conclusion

Rani Therapeutics stands at a pivotal juncture, transitioning from a promising clinical-stage entity to a financially fortified company with a validated, disruptive technology and a clear strategic roadmap. The RaniPill platform's ability to convert injectable biologics into convenient oral therapies, coupled with its demonstrated high bioavailability and safety profile, positions the company for significant market disruption, particularly in the burgeoning obesity and immunology sectors. The recent, substantial financing and the strategic collaboration with Chugai Pharmaceutical Co. (CHGCY) have not only addressed immediate liquidity concerns but have also provided a robust foundation for advancing Rani's pipeline into 2028.

While the company anticipates continued operating losses as it invests in development and manufacturing scale-up, the potential for RT-114 and RT-116 to offer differentiated, patient-preferred oral options in the obesity market, alongside the breakthrough of an oral monoclonal antibody with RT-111, underscores a compelling investment thesis. The successful execution of ongoing clinical trials, the realization of milestone payments from collaborations, and the continued optimization of its manufacturing capabilities will be critical determinants of Rani's long-term success. With its innovative technology and strengthened financial position, Rani Therapeutics is well-positioned to unlock the vast potential of oral biologics and reshape the future of chronic disease management.