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On Wednesday, BTIG analysts maintained a Buy rating and a $14.00 price target for Rani Therapeutics Holdings Inc. (NASDAQ:RANI), representing significant upside potential from the current price of $1.44. According to InvestingPro data, analyst targets range from $8 to $17, though the company’s financial health score is currently rated as weak. The positive outlook follows the Phase 1 multiple ascending dose (MAD) data for PG-102, the active pharmaceutical ingredient in RT-114, which has shown promising results in treating patients with obesity and type 2 diabetes. With a market capitalization of $82.7 million, Rani is actively pursuing this opportunity despite currently burning through cash, as highlighted in InvestingPro’s analysis.
The data revealed an average absolute weight loss of 4.8% at the five-week mark, which is notably higher than the weight loss reported with semaglutide (approximately 2.0%) and tirzepatide (around 2.8%) at the same stage in their pivotal development. Some individuals experienced weight loss of up to 8.7% within the same time frame. Notably, PG-102 was administered under an accelerated titration regime, allowing participants to reach the target dose within one month, significantly faster than the 4-6 months typically required for existing therapies.
Moreover, the study observed no instances of vomiting, with less than 30% of patients experiencing nausea and less than 20% reporting diarrhea. The analysts suggest that a lower peak concentration and potentially broader area under the curve (AUC) for PG-102, as seen with Rani’s RT-114, could offer even better tolerability and a wider therapeutic window. Throughout the Phase 1 trial, no patients discontinued treatment due to adverse effects. While the clinical results are promising, investors should note that the company reported an EBITDA of -$50.8 million in the last twelve months, reflecting its development-stage status.
The company is preparing for an Investigational New Drug (IND) submission for RT-114, expected later in the first half of 2025. Full results from the PG-102 Phase 1 study are anticipated to be presented at the American Association of Scientific Diabetes (AASD) meeting, scheduled for March 28-30, 2025.
Additionally, PG-102 is advancing through a Phase 2 study in South Korea, which is currently enrolling patients with type 2 diabetes and obesity. Initial proof of concept data from this study is expected in the first half of 2025. For investors following this development, InvestingPro offers additional exclusive insights and financial metrics to evaluate Rani’s progress and market position, including detailed analysis of its cash flow and growth potential. BTIG analysts also pointed out that upcoming data from ZEAL’s 28-week Phase 1b study of dapiglutide, a peptide-based GLP1/2 agonist, expected later in the first half of 2025, could provide further insights relevant to RT-114/PG-102’s development.
In other recent news, Rani Therapeutics has reported positive results from a preclinical study on the oral delivery of semaglutide for obesity treatment using their RaniPill® HC technology. The study demonstrated that oral semaglutide achieved comparable bioavailability and pharmacokinetics to its traditionally injected form, with similar weight loss outcomes observed in canines. The oral version was well tolerated, showing no serious adverse events, and achieved a relative bioavailability of 107% compared to the injected form. This development is significant as there are currently no approved oral GLP-1 agonists for obesity on the market. Jesper Høiland, a Senior Strategic Advisor for Rani Therapeutics, noted the transformative potential of this treatment. Additionally, Rani Therapeutics plans to initiate a Phase 1 clinical trial in 2025 for RT-114, an oral GLP-1/GLP-2 dual agonist developed in partnership with ProGen. These advancements highlight the company’s efforts in developing innovative oral biologic delivery systems.
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