Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics, today announced the development of a high-capacity oral biologics device known as the RaniPill™ HC (High Capacity), capable of delivering up to a 500%-plus higher drug payload than Rani’s existing oral biologics capsule. In preclinical testing, RaniPill™ HC demonstrated successful delivery of adalimumab and achieved high bioavailability.

“The RaniPill™ HC gives us the potential to deliver a much broader range of biologic drugs with its higher capacity of up to 20mg of drug per capsule,” said Mir Imran, Rani’s founder and Executive Chairman. “In addition, since the RaniPill™ HC shares many similarities with our existing RaniPill™ capsule, we are confident in our ability to achieve similar safety and performance metrics, and to leverage our existing investments in manufacturing and automation.”

Today, biologics are predominantly delivered via injection or intravenous infusion, which limits long-term treatment adherence, often leading to suboptimal patient outcomes. An equally effective oral alternative could change the treatment paradigm for a number of patient populations, including those with autoimmune diseases, cancer, and diabetes.

“Therapeutic drug development has yielded a vast array of molecular entities, including peptides, antibodies and oligonucleotides. The new technology from Rani now allows for the potential oral administration of these drugs irrespective of their size or chemical nature,” said Dr. Dennis Ausiello, a member of Rani’s Board of Directors. Dr. Ausiello is the Director of the Center for Assessment Technology & Continuous Health (CATCH) and was previously Chief of Medicine at Massachusetts General Hospital.

Rani conducted a preclinical study of RaniPill™ HC, with each device containing an 18mg dose of the biologic adalimumab, a tumor necrosis factor (TNF)-α inhibitor that is approved for multiple autoimmune conditions including rheumatoid arthritis and Crohn’s disease. The unencapsulated RaniPill™ HC device was placed laparoscopically in the jejunum of each of three canine test subjects and allowed to self-deploy under observation. Successful delivery was achieved in all cases, and systemic serum drug concentration was detected and measured over 5 days.

“The RaniPill™ HC is a major milestone for our platform technology. It opens up a significant number of opportunities for new pipeline drugs and partnerships,” said Talat Imran, Rani’s CEO. “This sets the stage for the rest of the year, as we anticipate moving two programs into the clinic using our existing RaniPill™ capsule, while also advancing development of the RaniPill™ HC for high-dose biologics. We believe these technologies have the potential to improve the lives of millions of patients with chronic diseases who currently depend on frequent injections.”

Preliminary Consolidated Financial Results


Rani’s preliminary consolidated financial results for the three months and year ended December 31, 2021 are presented below, and the results are subject to finalization of the Company’s customary quarterly and annual financial close processes.

Rani estimates that net loss will be between $13.0 million and $15.0 million for the fourth quarter of 2021, compared to $5.8 million for the fourth quarter of 2020, and between $53.0 million and $55.0 million for the full-year 2021, compared to $16.7 million for full-year 2020. The net loss includes estimated equity-based compensation expense of approximately $3.2 million for the fourth quarter of 2021 and approximately $22.6 million for the full-year 2021. There was no equity-based compensation expense for the fourth quarter of 2020 nor full year-year 2020.

Rani estimates that cash and cash equivalents will be approximately $117.5 million as of December 31, 2021.

Source: Company Press Release