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On Thursday, Stifel analysts upheld their Buy rating and $8.00 price target for Rani Therapeutics Holdings Inc. (NASDAQ:RANI), following promising preclinical study results. Currently trading at $1.43, with a market cap of $82 million, the stock has seen a challenging year, down over 50% in the past 12 months. According to InvestingPro analysis, the company appears undervalued relative to its Fair Value. The company’s RT-114 capsules, which are designed to deliver the drug PG-102 orally using RaniPill technology, demonstrated a relative bioavailability of 111%. This figure indicates that the oral delivery method is bioequivalent to the subcutaneous injection of PG-102, based on pharmacokinetic (PK) profiles from a head-to-head study. InvestingPro data reveals the company’s financial health score is rated as ’WEAK’, with significant cash burn - typical for biotech companies in the development stage.
The preclinical studies, which used canines as test subjects, showed a 90% success rate in delivering the medication, with 9 out of 10 canines successfully receiving the treatment. Additionally, the average peak weight loss recorded was similar between the two groups, at -6.7%, with the oral delivery method showing less variability.
Rani Therapeutics’ announcement comes after its partner ProGen released preliminary Phase 1 efficacy data of PG-102 for treating obesity and type 2 diabetes (T2D). The positive outcomes from the preclinical studies were a crucial step before advancing RT-114 into a Phase 1 clinical program for these conditions.
Analysts highlighted the potential benefits of RT-114, including once-weekly oral administration, competitive efficacy, and good tolerability, which allows for rapid titration to the target dose within a month. The favorable weight-to-muscle loss ratio observed in the studies is also gaining attention from regulators and clinicians.
The company is now preparing for the Investigational New Drug (IND) filing for RT-114, which is expected to occur in the first half of 2025. This development marks a significant milestone for Rani Therapeutics as it moves closer to potentially offering an innovative treatment option for patients with obesity and T2D. Investors should note that the company’s next earnings report is due on March 31, with analyst price targets ranging from $8 to $17, significantly above current levels. Get more detailed financial insights and additional ProTips with InvestingPro.
In other recent news, Rani Therapeutics Holdings, Inc. has reported promising results from a preclinical study for its oral obesity treatment, RT-114. The study demonstrated that RT-114, delivered via the RaniPill® capsule, achieved bioequivalence with its injectable counterpart, PG-102, in canines, showing comparable weight loss outcomes. The company plans to advance RT-114 into a Phase 1 clinical trial, expected to begin in mid-2025. Additionally, BTIG analysts have maintained a Buy rating for Rani Therapeutics, with a price target of $14, following positive Phase 1 data for PG-102, which showed significant weight loss in patients with obesity and type 2 diabetes. The analysts noted that PG-102’s accelerated titration regime allowed for faster dose achievement compared to existing therapies. Furthermore, Rani Therapeutics is preparing for an Investigational New Drug submission for RT-114, anticipated in the first half of 2025. The company is also collaborating with ProGen Co., Ltd. on the development and potential commercialization of RT-114. These developments underscore Rani Therapeutics’ efforts to transform obesity treatment with its innovative oral drug delivery technology.
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