Zacks Small Cap Research – RANI: New Triagonist Data in Weight Loss – Technologist

By John Vandermosten, CFA

NASDAQ:RANI

READ THE FULL RANI RESEARCH REPORT

Rani Therapeutics Holdings, Inc. (NASDAQ:RANI) provided a look at new preclinical data for a glucagon-like peptide-1 (GLP-1) incretin triagonist. In addition to a discussion to this data, we review the recent $10 million capital raise. The molecule reviewed in the October 17th press release demonstrated 80% bioavailability relative to subcutaneous delivery and produced weight loss over the measurement period in an animal model. The 8-subject study administered the incretin triagonist to canines. The molecule contains GLP-1, glucose-dependent insulinotropic polypeptide (GIP) and glucagon receptors. It was administered either through an endoscope-guided transenteric mechanism to mirror RaniPill administration or subcutaneous (SC) injection. The preclinical study evaluated the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of the molecule which should provide further support for delivery using the Rani Pill.

The study consisted of two arms with three subjects in Group 1 which received the triagonist molecule via an endoscope-guided transenteric administration and five subjects that received the SC administration. Note that these are small numbers which lack statistical significance. For transenteric delivery, the area under the curve (AUC) in nmol*h/L was 26,963 and the concentration maximum (C_MAX) was 334. Time to maximum concentration was 16.7 hours. In the SC arm, AUC was 33,509 and C_MAX was 311. Time to maximum concentration was 24 hours. A representation of this data is in the exhibit below.

Data was collected over a two-week period for analysis of serum drug concentrations and various PD and safety biomarkers. Further analyses examined weight loss in the two study arms. Canines that received the transenteric delivery of drug saw a 9.7% decline in body weight while SC injected models saw a 6.9% decrease. The weight benefit was attributed to early satiety and reduced caloric intake. As a visual aid, peak decreases in body weights are provided in graphical form in the following exhibit. The time intervals for this metric were not given; however, peak weight loss was generally in a range of seven to eleven days after administration.

With the triagonist preclinical effort complete, attention turns to the preclinical work necessary to begin the Phase Ia/Ic trial with RT-114. A PK study is required before going into the clinic and will also dose canines. However, the Rani Pill will be used rather than transenteric delivery in order to gain additional insight. Beyond the PK animal study, chemistry, manufacturing and controls (CMC) work must be completed, which is expected to be done before year end. The Phase Ia/Ic trial is on track for an early 2025 launch.

Capital Raise

On October 15th, Rani announced pricing of a $10 million capital raise which has since closed. The transaction includes 3,000,000 shares of Rani Class A common stock and 333,333 pre-funded warrants to purchase Rani Class A common stock. Each share or pre-funded warrant will include a common warrant with an exercise price of $3.00 per share with a life of five years. Each share and warrant will be sold at a purchase price of $3.00. Along with the capital raise transaction, Rani has entered into an agreement with an investor to cancel all outstanding Series A common warrants issued on July 22, 2024. This totals 3,246,753 warrants. The deal closed shortly after the announcement and the associated funds have been added to the balance sheet.

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