Rani Therapeutics Announces up to $1.085 Billion Collaboration with Chugai Pharmaceutical Co. for Multiple High-Value Therapeutics Including Rare Disease and Immunology Programs and Announces Concurrent Oversubscribed $60.3 Million Financing

Rhea-AI Summary

Rani Therapeutics (Nasdaq: RANI) announced a Collaboration and License Agreement with Chugai on October 17, 2025 to develop an oral product using RaniPill and a Chugai rare‑disease antibody.

Key terms: $10 million upfront, up to $75 million in technology transfer and development milestones, up to $100 million in sales milestones, single‑digit royalties, and an option for Chugai to add up to five additional targets — bringing total potential deal value to $1.085 billion. Rani also announced an oversubscribed $60.3 million PIPE led by Samsara BioCapital; net proceeds plus upfront and an expected $18.0 million technology transfer milestone are expected to fund operations into 2028.

Positive

• $10M upfront payment secured
• Total potential deal value of $1.085B
• $60.3M oversubscribed private placement (PIPE)
• Expected funding into 2028 from proceeds and milestones

Negative

• PIPE equity financing may dilute existing shareholders
• Operational runway contingent on $18.0M milestone realization

Insights

Biotech partnership strategist

Large collaboration plus PIPE strengthens development runway and validates RaniPill® for rare and immunologic biologics.

Rani Therapeutics secures a multi-layered deal with Chugai that provides immediate non-dilutive capital ($10 million upfront) and milestone payments tied to technology transfer (up to $75 million) and commercial performance (up to $100 million), with single-digit royalties. The option to extend to up to five additional targets raises the total potential consideration to $1.085 billion, which signals strategic validation of the oral delivery platform for high-value antibody programs.

The business mechanism is straightforward: Chugai funds development and commercialization while licensing Rani's delivery technology, de-risking Rani's clinical and regulatory execution burden. Key dependencies include successful technology transfer milestones and eventual commercial adoption; both are explicitly milestone- and sales-contingent, so upside is conditional rather than guaranteed. Watch progress on the stated technology transfer milestones and any announcement of the first regulatory or clinical readouts; these will determine near-term de-risking and timing of contingent payments within the stated runway to 2028.

Corporate financing and runway analyst

Concurrent $60.3 million PIPE plus upfront and milestone cash materially extends runway into 2028.

Rani completed a private placement led by Samsara BioCapital that brings expected gross proceeds of $60.3 million. Combined with the $10 million upfront and an $18.0 million technology-transfer milestone expected from Chugai, management states these proceeds are expected to fund operations into 2028. That explicit funding horizon reduces near-term refinancing risk and supports continued development of partnered and internal programs.

Risks remain: milestone and sales payments are contingent, and the PIPE is subject to customary closing conditions. Monitor actual receipt of the announced $18.0 million technology-transfer milestone and the timing of PIPE closings. The next 12–24 months should reveal whether milestone triggers occur and whether additional target exercises by Chugai materialize under the optional pathway.

• Rani will receive $10 million upfront payment and is eligible to receive up to $75 million in technology transfer and development milestones, up to $100 million in sales milestones and single digit royalties on product sales for the first license agreement
  
• Chugai has the option to extend its rights to partner with Rani on up to 5 additional drug targets at similar deal terms bringing the total potential deal value to over $1 billion
  
• Rani announced a $60.3 million private placement financing led by Samsara BioCapital with participation from other new and existing investors, including RA Capital Management, Anomaly, Special Situations Funds, Invus, and Founder and Chairman, Mir Imran
  

SAN JOSE, Calif., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced that it has entered into a Collaboration and License Agreement with Chugai Pharmaceutical Co., Ltd. ("Chugai") for the development and commercialization of an oral product consisting of Rani’s oral delivery technology, the RaniPill^®, and Chugai’s rare disease antibody in development.

“This partnership represents a convergence of Rani’s cutting-edge oral delivery platform technology and Chugai’s expertise in the research, development and commercialization of complex antibodies in global markets for multiple disease areas with high unmet medical needs, including rare and immunologic diseases,” said Talat Imran, Chief Executive Officer of Rani Therapeutics. “There are many cases where oral therapies for the treatment of multiple disease areas with high unmet medical needs, including rare and immunologic diseases, are limited and as a result, patients rely primarily on injections that can be burdensome and impact adherence. Rani is committed to addressing this gap by developing innovative oral treatments that simplify disease management, reduce treatment burden, and ultimately enhance patient quality of life. We are excited to be uniting two powerful scientific teams to advance a potential breakthrough therapy with the power to dramatically change how these challenging diseases are treated around the world.”

Under the terms of the agreement for the first drug target, Rani will receive $10 million up front and is eligible to receive up to $75 million contingent upon the achievement of success-based technology transfer and development milestones, up to $100 million in a series of sales-based milestones, contingent upon the commercial success of the product, and single digit royalties on sales upon successful commercialization of the product. In addition, Chugai has the option to extend its rights to up to 5 additional drug targets under similar deal terms which, if fully exercised by Chugai, could bring the total deal value to $1.085 billion.

“Rani's innovative oral delivery technology opens up new possibilities for the administration of biologics, which have traditionally been limited to injections. By integrating Rani's technology with our proprietary antibody engineering technologies cultivated over many years, we expect to create entirely new value in the form of oral therapies that are less burdensome for patients. Through this collaboration, we will accelerate our challenge to realize advanced, patient-centric healthcare,” said Dr. Tomoyuki Igawa, Chugai’s Vice President and Head of Research Division.

Private Placement

Rani has entered into a securities purchase agreement for a private placement in public equity financing (“PIPE”) that is expected to result in gross proceeds of approximately $60.3 million to Rani, led by Samsara BioCapital with participation from other new and existing investors, including, RA Capital Management, Anomaly, Special Situations Funds, Invus, and Founder and Chairman, Mir Imran. The anticipated net proceeds from the PIPE, together with the initial upfront payment and the expected technology transfer milestones of $18.0 million from the agreement with Chugai, are expected to fund the Company’s operations into 2028.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Rani Therapeutics

Rani Therapeutics is a clinical-stage biotherapeutics company focused on advancing technologies to enable the development of orally administered biologics and drugs. Rani has developed the RaniPill^® capsule, which is a novel, proprietary and patented platform technology, intended to replace subcutaneous injection or intravenous infusion of biologics and drugs with oral dosing. Rani has successfully conducted several preclinical and clinical studies to evaluate safety, tolerability and bioavailability using RaniPill^® capsule technology. For more information, visit ranitherapeutics.com.

About Chugai Pharmaceutical

Chugai Pharmaceutical Co., Ltd., headquartered in Tokyo, is a research-based pharmaceutical company with world-class drug discovery capabilities, including proprietary antibody engineering technologies. Chugai is committed to creating innovative pharmaceutical products that may satisfy unmet medical needs. Chugai is listed on the Prime Market of the Tokyo Stock Exchange. While maintaining autonomy and management independence, Chugai is an important member of the Roche Group. Additional information is available at https://www.chugai-pharm.co.jp/english/.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Rani’s ability to achieve the success-based technology transfer and development milestones, and the potential to receive such milestone payments, the potential for Rani to receive sales milestone payments and royalties on sales, the potential for Chugai to extend its rights to the additional targets, the total potential deal value, Rani and Chugai’s ability to successfully develop and commercialize an oral product, Rani’s ability to develop innovative oral treatments that simplify disease management, reduce treatment burden, and ultimately enhance patient quality of life, Rani and Chugai’s ability to advance a potential breakthrough therapy with the power to dramatically change how rare diseases are treated around the world, the potential for the RaniPill to transform patient care by making complex therapies more accessible and convenient, Rani and Chugai’s ability to deliver a transformative oral therapy to the global rare disease community, Rani’s ability to advance technologies to enable the development of orally administered biologics and drugs, the expected gross proceeds and closing date of the PIPE financing, and Rani’s cash sufficiency forecast. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “believe,” “potential,” “expect,” “may,” “could” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Rani’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with the possibility that the product(s) may not be successfully developed or commercialized, that regulatory approvals may be delayed or denied, that anticipated milestones may not be achieved, that Chugai may choose not to extend its rights to the additional targets, or with Rani’s business in general and the other risks described in Rani’s filings with the Securities and Exchange Commission, including Rani’s annual report on Form 10-K for the year ended December 31, 2024, and subsequent filings and reports by Rani. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Rani undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Investor Contact:

investors@ranitherapeutics.com 

Media Contact:

media@ranitherapeutics.com 

FAQ

What are the headline financial terms of Rani's deal with Chugai (RANI) announced Oct 17, 2025?

Rani receives $10M upfront, up to $75M in tech/development milestones, up to $100M in sales milestones, and single‑digit royalties; option could raise total value to $1.085B.

How much did Rani raise in the concurrent PIPE financing (RANI) and who led it?

Rani announced an oversubscribed $60.3M PIPE led by Samsara BioCapital with participation from RA Capital, Anomaly, Invus, and others.

Will the Chugai collaboration fund Rani's operations and for how long?

Rani says the PIPE proceeds, the $10M upfront, and an expected $18.0M technology transfer milestone are expected to fund operations into 2028.

What upside could Chugai exercise under the agreement with Rani (RANI)?

Chugai can opt to partner on up to 5 additional drug targets under similar terms, potentially raising deal value to $1.085B.

What commercial economics does Rani get if the partnered product succeeds?

Rani is eligible for sales‑based milestones up to $100M and will receive single‑digit royalties on product sales.

Does the PIPE financing present risks to Rani shareholders (RANI)?

The company raised $60.3M via a private placement, which may dilute existing shareholders and is a funding source tied to milestone achievement.