Financial Performance - Rani Therapeutics reported a net loss of $15.7 million for Q4 2024, compared to a net loss of $14.1 million in Q4 2023, and a full-year net loss of $56.6 million versus $67.9 million in 2023[9]. - Net loss for the three months ended December 31, 2024, was $15,721 million, compared to a net loss of $14,055 million in the same period of 2023, reflecting a 12% increase in losses[17]. - Net loss attributable to Rani Therapeutics Holdings, Inc. was $8,946 million for Q4 2024, compared to $7,099 million in Q4 2023, indicating a 26% increase in losses[17]. - Net loss per Class A common share attributable to Rani Therapeutics Holdings, Inc. was $0.27 for Q4 2024, unchanged from Q4 2023[17]. Revenue and Expenses - The company reported contract revenue of $1.0 million for both Q4 and full-year 2024, attributed to evaluation services, with no contract revenue in the same periods of 2023[8]. - Total operating expenses increased to $15,986 million in Q4 2024 from $13,435 million in Q4 2023, representing a 19% increase[17]. - General and administrative expenses for Q4 2024 were $5.5 million, down from $5.8 million in Q4 2023, with full-year expenses at $23.9 million compared to $26.5 million in 2023[8]. - Total operating expenses for the year ended December 31, 2024, were $54,342 million, down from $66,099 million in 2023, a decrease of about 18%[17]. - Interest income decreased to $361 million in Q4 2024 from $676 million in Q4 2023, a decline of approximately 47%[17]. - Impairment loss recorded in Q4 2024 was $3,714 million, with no impairment loss reported in Q4 2023[17]. Cash and Funding - Cash, cash equivalents, and marketable securities as of December 31, 2024, totaled $27.6 million, down from $48.5 million at the end of 2023, with expectations to fund operations into Q3 2025 without additional funding[8]. - The company completed two equity offerings in 2024, generating approximately $20.0 million in gross proceeds[4]. Research and Development - Research and development expenses for Q4 2024 were $6.8 million, a decrease from $7.6 million in Q4 2023, while full-year R&D expenses were $26.7 million compared to $39.6 million in 2023[8]. - Research and development expenses decreased to $6,810 million in Q4 2024 from $7,606 million in Q4 2023, a reduction of approximately 10%[17]. - The Phase 1 clinical trial for RT-114 is expected to initiate in mid-2025, focusing on obesity treatment[6]. - Rani Therapeutics announced preclinical data showing RT-114, a GLP-1/GLP-2 dual agonist, achieved a relative bioavailability of 111% compared to subcutaneous administration[8]. - Rani Therapeutics highlighted successful oral delivery of semaglutide via the RaniPill® capsule, demonstrating comparable bioavailability and weight loss to subcutaneous administration[3]. Partnerships and Market Position - The company has partnered with ProGen for the co-development and commercialization of RT-114, enhancing its market position in obesity treatments[4].

- Phase 1 study for RT-114 for the treatment of obesity, expected to initiate in mid-2025 - - Conference call today at 4:30 p.m. ET / 1:30 p.m. PT - SAN JOSE, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. ("Rani Therapeutics" or "Rani") (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today reported financial results for the quarter and full year ended December 31, 2024 and provided a corporate update. "We entered 202 ...

Core Insights - Rani Therapeutics has announced promising results for RT-114, an orally administered GLP-1/GLP-2 dual agonist, demonstrating bioequivalence to subcutaneously delivered PG-102 with a relative bioavailability of 111% [1][2][8] - The preclinical study showed comparable weight loss outcomes between RT-114 and SC PG-102, with RT-114 exhibiting less variability in weight loss results [1][4] - The company plans to initiate a Phase 1 clinical trial for RT-114 in mid-2025, furthering its commitment to developing oral therapies for obesity [1][9] Company Overview - Rani Therapeutics is focused on advancing oral delivery technologies for biologics and drugs, specifically through its proprietary RaniPill® capsule [10] - The company has successfully conducted multiple preclinical and clinical studies to evaluate the safety, tolerability, and bioavailability of its oral delivery system [10] - RT-114 is part of a collaboration agreement with ProGen, aimed at developing and commercializing the drug for weight management [11] Clinical Data Highlights - In a preclinical study, RT-114 achieved a peak weight loss of 6.7% with a delivery success rate of 90% in canines, indicating strong pharmacokinetic and pharmacodynamic relationships [8] - The Phase 1 clinical trial of SC PG-102 showed an average weight loss of 4.8% and up to 8.7% after five weeks of dosing, demonstrating the drug's effectiveness in obese patients [3][4] - The pharmacokinetic data indicated that RT-114 had a Cmax of 1.51 µg/mL/kg and Tmax of 0.7 days, compared to SC PG-102's Cmax of 1.06 µg/mL/kg and Tmax of 1.3 days [7][8] Market Potential - RT-114 is positioned to fill a critical gap in the obesity treatment landscape by providing an effective oral alternative to existing injectable GLP-1 receptor agonists [2][4] - The convenience of an oral dosing regimen is expected to enhance patient compliance and address challenges associated with current GLP-1 treatment options [2][4]

Core Viewpoint - Rani Therapeutics Holdings, Inc. is set to release its financial results for Q4 and the full year of 2024 on March 31, 2025, along with a business update [1] Group 1: Financial Results Announcement - Rani Therapeutics will announce its financial results for the fourth quarter and full year ended December 31, 2024 [1] - The announcement will take place after the close of trading on March 31, 2025 [1] - A conference call and webcast will be hosted by Rani's management team at 4:30 p.m. ET on the same day [2] Group 2: Company Overview - Rani Therapeutics is a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs [3] - The company has developed the RaniPill® capsule, a proprietary technology aimed at replacing subcutaneous injections or intravenous infusions with oral dosing [3] - Rani has successfully conducted several preclinical and clinical studies to evaluate the safety, tolerability, and bioavailability of its RaniPill® capsule technology [3]

Core Viewpoint - Rani Therapeutics Holdings, Inc. is set to release its financial results for Q4 and the full year of 2024 on March 31, 2025, along with a business update [1] Group 1: Financial Results Announcement - The company will announce its financial results for the fourth quarter and full year ended December 31, 2024 [1] - A conference call and webcast will be held on March 31, 2025, at 4:30 p.m. ET to discuss these results [2] Group 2: Company Overview - Rani Therapeutics is a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs [3] - The company has developed the RaniPill capsule, a proprietary technology aimed at replacing subcutaneous injections or intravenous infusions with oral dosing [3] - Rani has conducted several preclinical and clinical studies to evaluate the safety, tolerability, and bioavailability of its RaniPill® capsule technology [3]

Core Insights - Rani Therapeutics has demonstrated that oral semaglutide via the RaniPill® HC (RT-116) shows comparable bioavailability, pharmacokinetics, and weight loss effects to subcutaneous administration [1][3][9] - The RaniPill platform is gaining recognition for its potential to facilitate oral delivery of various obesity treatments, with plans for a Phase 1 study of RT-114, a GLP-1/GLP-2 dual agonist, expected to start in 2025 [1][10] Company Overview - Rani Therapeutics is a clinical-stage biotherapeutics company focused on developing technologies for the oral delivery of biologics and drugs, specifically through the RaniPill capsule [11] - The company aims to replace subcutaneous injections with oral dosing, enhancing patient convenience and adherence [11] Product Details - Semaglutide, a GLP-1 receptor agonist, mimics the activity of the GLP-1 hormone, which regulates appetite and food intake [2] - Currently, semaglutide is available only as a subcutaneous injection marketed as WEGOVY, with global sales of approximately $3.1 billion in the first half of 2024 [3][4] Study Findings - In a preclinical study, semaglutide was successfully delivered in 7 of 8 canines using the RaniPill capsule, showing comparable pharmacokinetic and pharmacodynamic profiles to subcutaneous administration [6][7] - The relative bioavailability of oral semaglutide was found to be 107% compared to subcutaneous administration, with both methods resulting in similar weight loss and reductions in serum triglycerides and cholesterol [9] Future Prospects - The company is optimistic about the potential of a once-weekly oral version of semaglutide to transform obesity treatment, providing a more convenient option for patients [4][3] - The initiation of the Phase 1 clinical trial for RT-114 is anticipated in 2025, further expanding Rani's obesity treatment portfolio [10]

Financial Performance - Net loss for the three months ended September 30, 2024, was $12,722 thousand, compared to a net loss of $18,332 thousand for the same period in 2023, reflecting a reduction of approximately 30%[7] - The company reported a net loss attributable to Rani Therapeutics Holdings, Inc. of $6,783 thousand for the three months ended September 30, 2024, compared to $9,197 thousand for the same period in 2023, a decrease of approximately 26%[7] - For the nine months ended September 30, 2024, the company reported a net loss of $40.9 million, compared to a net loss of $53.8 million for the same period in 2023, representing a 24.5% improvement[11] - The net loss for the quarter ending September 30, 2024, is $12,722,000, compared to a net loss of $14,779,000 for the previous quarter[9] - The net loss attributable to Rani Therapeutics Holdings, Inc. for the nine months ended September 30, 2024, was $21.1 million, resulting in a net loss per Class A common share of $(0.78)[45] - The company expects to continue incurring losses for the foreseeable future and will need to raise substantial capital to complete the development of the RaniPill platform[51] Revenue and Expenses - Total revenue for the three months ended September 30, 2024, was $6,172,000, a decrease of 45.0% compared to $11,220,000 for the same period in 2023[53] - Research and development expenses for the three months ended September 30, 2024, were $6,172 thousand, down from $11,220 thousand in the same period of 2023, a decrease of about 45%[7] - Total operating expenses for the nine months ended September 30, 2024, were $38,356 thousand, compared to $52,665 thousand for the same period in 2023, a reduction of approximately 27%[7] - Research and development expenses for the nine months ended September 30, 2024, totaled $19,872,000, down 37.9% from $32,018,000 in 2023[55] - General and administrative expenses decreased by $2.2 million to $18,484,000 for the nine months ended September 30, 2024, a reduction of 10.5% compared to $20,647,000 in 2023[55] - General and administrative expenses for the three months ended September 30, 2024, were $41,000, down from $87,000 for the same period in 2023, indicating a reduction of 52.9%[32] Assets and Liabilities - Total current assets decreased from $50,847 thousand as of December 31, 2023, to $32,371 thousand as of September 30, 2024, representing a decline of approximately 36%[6] - Total liabilities increased from $32,473 thousand as of December 31, 2023, to $37,765 thousand as of September 30, 2024, an increase of about 16%[6] - The total stockholders' equity attributable to Rani Therapeutics Holdings, Inc. decreased from $12,866 thousand as of December 31, 2023, to $3,120 thousand as of September 30, 2024, a decline of about 76%[6] - As of September 30, 2024, total stockholders' equity is $5,775,000, a decrease from $14,535,000 as of March 31, 2024[9] - The accumulated deficit increased to $93,960,000 as of September 30, 2024, from $80,372,000 at March 31, 2024[9] Cash Flow - Cash and cash equivalents decreased from $5,864 thousand as of December 31, 2023, to $4,277 thousand as of September 30, 2024, a decline of about 27%[6] - The company had negative cash flows from operations of $26.8 million for the nine months ended September 30, 2024, an improvement from negative cash flows of $38.8 million in the prior year[12] - Net cash provided by investing activities for the nine months ended September 30, 2024 was $17.3 million, primarily from $57.3 million in proceeds from maturities of marketable securities[65] - Net cash provided by financing activities for the nine months ended September 30, 2024 was $8.0 million, mainly from net proceeds of $8.9 million from the July Offering[65] Funding and Capital Needs - The company expects to continue generating operating losses and negative cash flows as it develops the RaniPill capsule, indicating a need for substantial additional funding in the future[13] - The company anticipates needing to raise substantial additional capital to fund ongoing operations and development activities, with existing resources deemed insufficient for the next twelve months[61] - The company may seek additional capital through equity offerings or debt financings, but restrictions from recent agreements could limit these options[61] - The company entered into a Controlled Equity Sales Agreement allowing it to offer and sell up to $150 million of Class A common stock, but has not made any sales under this agreement as of September 30, 2024[13] Strategic Initiatives - The company aims to advance product candidates and expand its platform technology, focusing on the development of the RaniPill HC and other future designs[5] - The Company entered into a Collaboration Agreement with ProGen Co., Ltd. in June 2024 to develop a weight management product, sharing development costs and operating profits equally[28] - The Company will lead the development of the weight management product in the U.S., Canada, Europe, and Australia, while ProGen will handle development in other countries[28] - The company plans to initiate clinical testing of the RaniPill HC in 2025, which is intended to deliver drug payloads up to 200µL in liquid form[49] Accounting and Compliance - The company is evaluating the impact of recently issued accounting pronouncements, including ASU 2023-07 and ASU 2023-09, on its financial statements[23] - The company recognizes revenue based on actual costs incurred as a percentage of total estimated costs, reflecting a cost-based input method for contract revenue recognition[21] - The company had no contract assets recorded as of September 30, 2024, indicating no unconditional right to consideration[22] - The company had deferred revenue of $0.6 million related to unsatisfied evaluation services as of September 30, 2024, compared to no deferred revenue as of December 31, 2023[22] Legal and Governance - The company is not currently involved in any litigation that is likely to materially affect its business[71] - Management believes that disclosure controls provide reasonable assurance but cannot guarantee detection of all errors or fraud[70] - The effectiveness of control systems is limited by resource constraints and the cost-benefit analysis of controls[70] - Inherent limitations in control systems may lead to undetected misstatements due to error or fraud[70]

Financial Performance - Net loss for Q3 2024 was $12.7 million, compared to $18.3 million for the same period in 2023, showing an improvement[5][9] - Net loss attributable to Rani Therapeutics Holdings, Inc. for Q3 2024 was $6.8 million, compared to $9.2 million in Q3 2023[9] - General and administrative expenses for Q3 2024 were $5.6 million, down from $6.6 million in Q3 2023, reflecting a decrease of $1.0 million[5][9] - Research and development expenses for Q3 2024 were $6.2 million, a decrease of $5.0 million compared to $11.2 million in Q3 2023[5][9] Cash and Liquidity - Completed two equity offerings with total gross proceeds of approximately $20.0 million, extending cash runway into Q3 2025[1][3] - Cash, cash equivalents, and marketable securities as of September 30, 2024, totaled $30.4 million, down from $48.5 million at the end of 2023[4] - Total liabilities as of September 30, 2024, were $37.8 million, an increase from $32.5 million at the end of 2023[8] Clinical Development - Initiation of Phase 1 clinical trial of RT-114, a GLP-1/GLP-2 dual agonist for obesity treatment, is expected in 2025[4][2] - New preclinical pharmacokinetic data supports transenteric delivery of GLP-1 incretin triagonist, enhancing the potential of the RaniPill® platform[2][3] Shareholder Information - Weighted-average Class A common shares outstanding for Q3 2024 were 28,836, up from 25,552 in Q3 2023[9]

Group 1 - Rani Therapeutics has entered into a securities purchase agreement for the sale of 3,000,000 shares of Class A common stock and pre-funded warrants to purchase 333,333 shares, along with Series C common warrants for a total of 3,333,333 shares at a combined price of $3.00 per share [1][2] - The gross proceeds from this offering are expected to be approximately $10.0 million before deducting fees and expenses [3] - The offering is expected to close on or about October 16, 2024, subject to customary closing conditions [3] Group 2 - The Series A common warrants, which allowed for the purchase of 3,246,753 shares, will be canceled and are no longer exercisable [2] - The securities are being offered under a "shelf" registration statement declared effective by the SEC on August 10, 2022 [4] - Rani Therapeutics focuses on the oral delivery of biologics and drugs, utilizing its proprietary RaniPill® capsule technology to replace subcutaneous injections or intravenous infusions [6]

Core Insights - Rani Therapeutics Holdings, Inc. is a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs [3] - The company will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on October 17, 2024 [1] Company Overview - Rani Therapeutics has developed the RaniPill® capsule, a proprietary platform technology aimed at replacing subcutaneous injection or intravenous infusion with oral dosing [3] - The company has successfully conducted several preclinical and clinical studies to evaluate the safety, tolerability, and bioavailability of the RaniPill® capsule technology [3]