RANI Rani Therapeutics Holdings Inc

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 its abstract entitled “An Orally Administered Robotic Pill (RP) Reliably and Safely Delivers the Human Parathyroid Hormone Analog hPTH (1-34) (Teriparatide) With High Bioavailability in Healthy Human Volunteers: A Phase 1 Study,” presented on June 17 by Joshua Myers, Director of Clinical Operations at Rani, won the Presidential Poster Competition in the Bone and Mineral Metabolism category at the 105th annual meeting of The Endocrine Society (ENDO 2023). The Endocrine Society committee recognized Rani for its exceptional scientific work on RT-102, the company’s oral robotic RaniPill® delivering teriparatide, or parathyroid hormone (PTH) (1-34), which is being developed as an oral osteoanabolic therapy for osteoporosis.

In addition, results of the RT-102 study and its clinical implications were presented and discussed by Dr. Arvinder Dhalla, Vice President of Clinical Development in a Tech news conference hosted by The Endocrine Society. Of the 2,500 submitted abstracts, The Endocrine Society selected 15 abstracts to be presented during the news conference and 18 were named Presidential Poster Competition winners. Information about ENDO 2023 may be accessed at https://endo2023.endocrine.org/Home.

The RaniPill® capsule is a robotic pill that is designed to deliver any injectable biologic drug painlessly, and is being tested as an oral alternative for a range of injection-only therapies in various therapeutic areas including osteoporosis, autoimmune diseases, fertility, rare diseases and multiple metabolic disorders. The RT-102 presentations at ENDO 2023 detailed the key findings from a Phase 1 study which demonstrated that oral administration of teriparatide via the RaniPill® capsule was well tolerated and reliably delivered the drug with bioavailability 3- to 4-fold times higher than that of subcutaneous injections of teriparatide.

“We are honored and humbled by the overwhelming endorsement of our work by our scientific peers this week at ENDO 2023 which culminated in the Presidential Poster Competition award. This is a reflection of the collective output of the multidisciplinary Rani team members, their dedication, the scientific rigor and the tireless work they have put in over the past many years developing the RaniPill® capsule, and demonstrates our commitment to better, more convenient treatment options in women’s health and beyond,” said Mir Hashim, Chief Scientific Officer of Rani. “The positive data from last year’s trial have propelled us forward, and we remain on track to launch a Phase 2 trial this year for RT-102 in patients with osteoporosis.”

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.

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, the expected initiation of a Phase 2 trial of RT-102 in the second half of 2023, the expected initiation of additional clinical trials of other product candidates with the RaniPill® platform, Rani’s advancement of its preclinical and clinical programs and timing of results, and Rani’s growth as a company. 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 “propel,” “on track,” “designed to” 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 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, 2022 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.

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