• 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

Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs,  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.