Rani Therapeutics (RANI) - 2025 Q1 - Quarterly Results

First Quarter 2025 Corporate Update Rani Therapeutics reported Q1 2025 financial results, highlighted promising preclinical data for RT-114 and oral semaglutide, and anticipates initiating a Phase 1 study for RT-114 in mid-2025 Executive Summary Rani Therapeutics reported Q1 2025 financial results and provided a corporate update, highlighting promising preclinical data for its RaniPill® platform in developing incretin-based therapies for obesity, including RT-114 and oral semaglutide. The company expects to initiate a Phase 1 study for RT-114 in mid-2025 - Rani Therapeutics is a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs via its RaniPill® capsule[1][7] - Preclinical data for RT-114 (bispecific GLP-1/GLP-2 receptor agonist) demonstrated bioequivalence to subcutaneous administration, with comparable pharmacokinetics, bioavailability, and weight loss[1][2] - Phase 1 study for RT-114 for the treatment of obesity is expected to initiate in mid-2025[1][2][4] - Preclinical data also showed successful oral delivery of semaglutide via RaniPill® capsule (RT-116), achieving comparable bioavailability, pharmacokinetics, and weight loss to subcutaneous semaglutide[1][6] Preclinical Data Achievements Rani Therapeutics announced significant preclinical data, demonstrating the bioequivalence of its oral RT-114 to subcutaneous administration of PG-102, achieving 111% relative bioavailability. Additionally, oral delivery of semaglutide (RT-116) via the RaniPill® capsule showed comparable efficacy and safety to subcutaneous semaglutide - RT-114 (oral bispecific GLP-1/GLP-2 receptor agonist) demonstrated 111% relative bioavailability compared to subcutaneously administered PG-102, with comparable pharmacokinetic profiles[6] - Oral delivery of semaglutide (RT-116) via RaniPill® capsule showed comparable bioavailability, pharmacokinetics, and weight loss to subcutaneous semaglutide, with no serious adverse events[6] Near-Term Milestone Expectations The primary near-term milestone for Rani Therapeutics is the initiation of a Phase 1 clinical trial for RT-114, targeting the treatment of obesity, which is anticipated to begin in mid-2025 - Initiation of Phase 1 clinical trial of RT-114 for the treatment of obesity is expected in mid-2025[4] Financial Highlights For Q1 2025, Rani Therapeutics reported contract revenue of $0.2 million, a decrease in R&D and G&A expenses, and a reduced net loss compared to Q1 2024. Cash, cash equivalents, and marketable securities decreased significantly from year-end 2024 Key Financial Highlights (Q1 2025 vs. Q1 2024) | Metric | Q1 2025 (in millions) | Q1 2024 (in millions) | Change (YoY) | | :-------------------------------- | :-------------------- | :-------------------- | :------------ | | Cash, Cash Equivalents & Marketable Securities (as of period end) | $15.9 | N/A | Down from $27.6M (Dec 31, 2024) | | Contract Revenue | $0.2 | $0.0 | Up $0.2M | | Research and Development Expenses | $6.6 | $7.6 | Down $1.0M | | General and Administrative Expenses | $5.6 | $6.4 | Down $0.8M | | Net Loss | $(12.7) | $(14.8) | Reduced by $2.1M | - Decrease in R&D expenses was primarily due to lower compensation costs[6] - Decrease in G&A expenses was primarily due to lower compensation costs ($0.4 million) and a reduction in third-party services ($0.5 million)[9] - Net loss for both periods included non-cash stock-based compensation expense of $3.9 million[9] Financial Statements This section presents the condensed consolidated balance sheets and statements of operations for Q1 2025, detailing asset, liability, equity changes, and operational performance Condensed Consolidated Balance Sheets As of March 31, 2025, Rani Therapeutics reported total assets of $24.1 million, a decrease from $36.6 million at December 31, 2024, primarily driven by a reduction in marketable securities and cash. Total liabilities also decreased, while stockholders' equity shifted from a positive balance to a deficit Condensed Consolidated Balance Sheets (Selected Items, in thousands) | Metric | March 31, 2025 (Unaudited) | December 31, 2024 | Change | | :------------------------------------ | :------------------------- | :---------------- | :----- | | Cash and cash equivalents | $10,111 | $3,762 | +$6,349 | | Marketable securities | $5,742 | $23,877 | -$18,135 | | Total current assets | $17,783 | $29,744 | -$11,961 | | Total assets | $24,125 | $36,634 | -$12,509 | | Total current liabilities | $20,130 | $19,891 | +$239 | | Total liabilities | $29,474 | $33,141 | -$3,667 | | Total stockholders' (deficit)/equity | $(5,349) | $3,493 | -$8,842 | - The company's accumulated deficit increased from $(102,907) thousand at December 31, 2024, to $(110,171) thousand at March 31, 2025[11] Condensed Consolidated Statements of Operations For the three months ended March 31, 2025, Rani Therapeutics reported contract revenue of $0.172 million, a net loss of $12.7 million, and a net loss attributable to Rani Therapeutics Holdings, Inc. of $7.264 million, resulting in a basic and diluted net loss per Class A common share of $(0.22). This represents an improvement in net loss compared to the same period in 2024 Condensed Consolidated Statements of Operations (Selected Items, in thousands, except per share amounts) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change (YoY) | | :-------------------------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Contract revenue | $172 | $— | +$172 | | Research and development expenses | $6,570 | $7,586 | -$1,016 | | General and administrative expenses | $5,615 | $6,448 | -$833 | | Total operating expenses | $12,185 | $14,034 | -$1,849 | | Loss from operations | $(12,013) | $(14,034) | +$2,021 | | Net loss | $(12,738) | $(14,779) | +$2,041 | | Net loss attributable to Rani Therapeutics Holdings, Inc. | $(7,264) | $(7,483) | +$219 | | Net loss per Class A common share, basic and diluted | $(0.22) | $(0.29) | +$0.07 | | Weighted-average Class A common shares outstanding | 33,440 | 26,034 | +7,406 | Company Information This section provides an overview of Rani Therapeutics, outlines forward-looking statements, and lists contact information for investor and media inquiries About Rani Therapeutics Rani Therapeutics is a clinical-stage biotherapeutics company dedicated to developing technologies for the oral administration of biologics and drugs. Its core innovation is the RaniPill® capsule, a proprietary platform designed to replace injections with oral dosing, which has shown promising results in preclinical and clinical studies for safety, tolerability, and bioavailability - Rani Therapeutics is a clinical-stage biotherapeutics company focused on advancing technologies for orally administered biologics and drugs[7] - The company developed the RaniPill® capsule, a novel, proprietary, and patented platform technology intended to replace subcutaneous injection or intravenous infusion with oral dosing[7] - RaniPill® capsule technology has been evaluated in several preclinical and clinical studies for safety, tolerability, and bioavailability[7] Forward-Looking Statements This section contains standard forward-looking statements regarding future events, including the expected initiation of the RT-114 Phase 1 trial, the potential of the RaniPill® platform, and future financial performance. It emphasizes that actual results may differ materially due to various risks and uncertainties, and the company undertakes no obligation to update these statements - Statements in the press release regarding future events, such as the initiation of the RT-114 Phase 1 trial in mid-2025 and the potential of the RaniPill® platform, are forward-looking[8] - Actual results may differ materially from forward-looking statements due to various risks and uncertainties, including those described in Rani's SEC filings[8] - Rani Therapeutics does not undertake any obligation to update forward-looking statements, except as required by law[8] Contact Information This section provides contact details for investor and media inquiries - Investor contact email: investors@ranitherapeutics.com[9] - Media contact email: media@ranitherapeutics.com[9]