RANI announces positive Phase 1 results for RT-111 ustekinumab biosimilar

March 23, 2024 | by


RANI Therapeutics Holdings, Inc., a leading biotechnology company, recently held its Q4 2023 earnings call, where substantial progress in its pipeline programs and delivery device development was highlighted. The company proudly announced the favorable Phase 1 results for RT-111, an orally administered ustekinumab biosimilar. The study indicated high bioavailability and the absence of any serious adverse events, thus positioning RT-111 as a promising treatment option. In addition to this achievement, RANI expanded its partnerships with Celltrion for the development of adalimumab biosimilars. Furthermore, the company showcased the successful oral delivery of adalimumab and other antibody and peptide molecules using their innovative RaniPill platform. Notably, preclinical data also demonstrated the platform’s potential in facilitating the oral delivery of obesity treatments. Given its robust financial position, RANI Therapeutics is well-positioned for future growth with $48.5 million in cash, cash equivalents, and marketable securities. The company aims to raise additional capital through equity offerings, debt financing, and potential licensing fees. With research and development expenses amounting to $39.6 million in 2023, and general and administrative expenses totaling $26.5 million, RANI Therapeutics continues its commitment to advancing groundbreaking therapies and revolutionizing drug delivery.

Positive Phase 1 Results for RT-111 Ustekinumab Biosimilar

Rani Therapeutics Holdings, Inc. (RANI) announced positive Phase 1 results for RT-111, its orally administered ustekinumab biosimilar. Ustekinumab is an important therapy used to treat autoimmune conditions such as psoriasis and psoriatic arthritis. The oral administration of RT-111 offers a significant advantage over traditional injectable forms of ustekinumab, providing patients with a more convenient and comfortable treatment option.

One key highlight of the Phase 1 results is the high bioavailability of RT-111. Bioavailability refers to the extent and rate at which a drug is absorbed into the systemic circulation. The high bioavailability of RT-111 indicates that the drug is efficiently and rapidly absorbed by the body, allowing for optimal therapeutic effects. This is an encouraging finding that suggests RT-111 has the potential to be as effective as the reference ustekinumab while offering the added benefit of oral administration.


Furthermore, the Phase 1 trial of RT-111 reported no serious adverse events. This is a significant achievement as safety is of utmost importance in the development of any new medication. The absence of serious adverse events indicates that RT-111 is well-tolerated and has a favorable safety profile. This positive safety data is critical for ensuring patient confidence and regulatory approval in subsequent phases of clinical development.

The positive Phase 1 results for RT-111 represent a significant milestone for Rani Therapeutics. The company’s commitment to innovation and improving patient outcomes is evident in the development of this novel and promising biosimilar. With further clinical studies, RT-111 has the potential to revolutionize the treatment of autoimmune conditions by offering patients a convenient and effective oral therapy.


Expansion of Partnerships with Celltrion

Rani Therapeutics is pleased to announce the expansion of partnerships with Celltrion for the development of adalimumab biosimilars. Adalimumab is a widely used therapy for various autoimmune conditions, including rheumatoid arthritis, psoriasis, and Crohn’s disease. By partnering with Celltrion, a leading biopharmaceutical company with expertise in biosimilar development, Rani Therapeutics aims to leverage Celltrion’s scientific knowledge and manufacturing capabilities to accelerate the development and commercialization of adalimumab biosimilars.

The expansion of partnerships with Celltrion signifies Rani Therapeutics’ commitment to expanding its biosimilar portfolio and addressing the unmet medical needs of patients worldwide. Adalimumab biosimilars have the potential to significantly reduce healthcare costs and increase patient access to this important therapy. With Celltrion’s support, Rani Therapeutics can leverage its innovative oral delivery platform to develop adalimumab biosimilars that offer enhanced convenience and accessibility to patients.


This partnership expansion reflects Rani Therapeutics’ strategic approach to collaboration and its dedication to advancing the field of biosimilars. By partnering with industry leaders like Celltrion, Rani Therapeutics can tap into a wealth of expertise and resources, allowing for a more efficient and streamlined development process. This collaboration holds great promise in bringing high-quality, cost-effective adalimumab biosimilars to market and improving patient care.

Success of RaniPill Platform

Rani Therapeutics celebrates the success of its proprietary RaniPill platform, which has demonstrated the oral delivery of adalimumab and other antibody and peptide molecules. The RaniPill platform represents a groundbreaking advancement in drug delivery, enabling the oral administration of therapies that were previously limited to injectable forms. This innovative technology has the potential to transform the treatment landscape for various diseases and improve patient adherence and quality of life.


The success of the RaniPill platform in delivering adalimumab orally is particularly noteworthy. Adalimumab is a widely used therapy for inflammatory conditions such as rheumatoid arthritis and psoriasis. By allowing for oral administration of adalimumab, the RaniPill platform offers patients a less invasive and more convenient treatment option. This is a significant achievement that has the potential to revolutionize the way adalimumab and other similar therapies are administered.

Moreover, preclinical data has demonstrated the potential for the RaniPill platform to enable the oral delivery of obesity treatments. Obesity is a global health challenge that requires effective and accessible treatment options. The RaniPill platform’s ability to safely and effectively deliver obesity treatments orally could have a profound impact on addressing this epidemic. This potential expansion of the RaniPill platform’s applications highlights its versatility and its potential to transform healthcare across a range of therapeutic areas.

The success of the RaniPill platform underscores Rani Therapeutics’ commitment to innovation and improving patient outcomes. By leveraging this proprietary technology, Rani Therapeutics aims to bring more therapies within the reach of patients globally and redefine the standard of care. Continued advancements in the RaniPill platform have the potential to reshape the pharmaceutical industry and improve the lives of countless individuals.

Financial Position

Rani Therapeutics is pleased to report a strong financial position, with $48.5 million in cash, cash equivalents, and marketable securities. This robust financial position provides Rani Therapeutics with the resources needed to advance its pipeline programs, drive innovation, and pursue strategic initiatives. It demonstrates the company’s financial stability and its ability to execute its business plans effectively.

The substantial cash reserves, cash equivalents, and marketable securities reflect Rani Therapeutics’ successful efforts in securing funding and attracting investment. This financial strength positions the company well for future growth and expansion, enabling it to continue its pursuit of groundbreaking therapies and innovative drug delivery technologies. Rani Therapeutics’ fiscal stability also instills confidence in its stakeholders, including investors, partners, and healthcare professionals.

The strong financial position of Rani Therapeutics not only supports its existing programs but also allows for flexibility in pursuing new opportunities and collaborations. It provides a solid foundation for the development of new biosimilars, the advancement of the RaniPill platform, and the exploration of novel therapeutic areas. Rani Therapeutics’ financial stability amplifies its ability to make strategic decisions that will benefit patients, investors, and the healthcare industry as a whole.

Capital Raising Plans

To further support its growth and development initiatives, Rani Therapeutics intends to raise additional capital through various avenues. The company plans to utilize equity offerings as a means of raising capital, ensuring the necessary financial resources for research, development, and commercialization efforts. By offering equity in the company, Rani Therapeutics can attract investment from individuals and institutions that recognize its potential for success.

In addition to equity offerings, Rani Therapeutics is also exploring debt financing options. Debt financing allows the company to secure capital by borrowing funds from lenders, with the commitment to repay the principal amount along with any accrued interest. This form of financing can provide Rani Therapeutics with the necessary funds to scale its operations, expand its manufacturing capabilities, and accelerate the development of pipeline programs.

Furthermore, Rani Therapeutics anticipates potential licensing fees to contribute to its capital raising efforts. The company’s innovative drug delivery technologies and biosimilar pipeline have garnered interest from potential partners and collaborators. Through licensing agreements, Rani Therapeutics can grant others the rights to leverage its technologies or develop therapies based on its intellectual property in exchange for licensing fees. These fees can serve as a valuable source of income for Rani Therapeutics, strengthening its financial position and supporting its continued growth.

By pursuing a combination of equity offerings, debt financing, and potential licensing fees, Rani Therapeutics aims to secure the necessary capital to advance its strategic objectives. These capital raising plans reflect the company’s proactive approach to fueling its ambitious growth plans and ensuring the successful commercialization of its innovative therapies and drug delivery platforms.

Research and Development Expenses

Rani Therapeutics prioritizes research and development as a crucial investment in advancing its pipeline programs and proprietary technologies. In 2023, the company incurred research and development expenses totaling $39.6 million. This significant investment highlights Rani Therapeutics’ commitment to scientific excellence, innovation, and the pursuit of groundbreaking therapies.

The substantial research and development expenses underscore the company’s dedication to driving advancements in drug delivery and biosimilar development. Rani Therapeutics recognizes the importance of staying at the forefront of scientific research, which requires ongoing investment in cutting-edge technologies, preclinical studies, and clinical trials. By allocating significant resources to research and development, Rani Therapeutics is positioned to bring innovative therapies to market and improve patient outcomes.

The research and development expenses in 2023 encompassed a range of activities, including preclinical research, clinical studies, regulatory submissions, and manufacturing process optimization. These multifaceted initiatives are critical for ensuring the safety, efficacy, and quality of Rani Therapeutics’ therapies and technologies. The substantial investment in research and development reflects Rani Therapeutics’ commitment to scientifically rigorous and ethically sound practices.

By investing in research and development, Rani Therapeutics not only advances its own proprietary programs but also contributes to the broader scientific and healthcare communities. The knowledge gained through these endeavors has the potential to shape the future of drug delivery and biosimilar development, benefitting patients and healthcare professionals worldwide. Rani Therapeutics’ commitment to research and development underscores its mission to improve the lives of individuals through innovative therapies and drug delivery solutions.

General and Administrative Expenses

In addition to research and development expenses, Rani Therapeutics incurs general and administrative expenses to support its operations and strategic business functions. In 2023, the company reported general and administrative expenses totaling $26.5 million. These expenses encompass various aspects of day-to-day operations, including corporate management, legal and regulatory compliance, investor relations, and administrative support.

The general and administrative expenses serve as a necessary investment in Rani Therapeutics’ overall business infrastructure and corporate governance. They support the company’s ability to execute its business strategy effectively, comply with regulatory requirements, and maintain transparent and constructive communication with stakeholders. By allocating resources to these functions, Rani Therapeutics ensures the smooth operation of its business and its ability to deliver on its commitments.

Moreover, general and administrative expenses provide Rani Therapeutics with the necessary resources to attract and retain top talent, foster innovation, and advance its strategic initiatives. By investing in areas such as legal and regulatory compliance, corporate governance, and investor relations, Rani Therapeutics demonstrates its commitment to accountability, transparency, and stakeholder value.

The general and administrative expenses incurred by Rani Therapeutics also include costs associated with business development and partnerships. As the company expands its collaborations and pursues new opportunities, it incurs expenses related to due diligence, negotiations, and operational integration. These expenses are essential for driving growth, capitalizing on market opportunities, and expanding Rani Therapeutics’ reach in the global healthcare landscape.

In conclusion, Rani Therapeutics’ general and administrative expenses reflect the company’s commitment to sound corporate governance, operational excellence, and stakeholder value creation. By allocating resources to these essential functions, Rani Therapeutics ensures its ability to execute its strategic vision, deliver innovative therapies, and positively impact the lives of patients.



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