Our mission at Rani is to end painful injections for the millions of patients suffering from chronic diseases. Rani Therapeutics Fourth Quarter and Full Year Financial Results and Business Update March 31, 2025 1 Trade names, trademarks and service marks of other companies appearing in this presentation are the property of their respective owners. Solely for convenience, the trademarks and trade names referred to in this presentation appear without the ® and symbols, but those references are not intended to ...

Financial Data and Key Metrics Changes - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $27.6 million, down from $48.5 million as of December 31, 2023, indicating a significant decrease in liquidity [40] - The net loss for Q4 2024 was $15.7 million, compared to a net loss of $14.1 million in Q4 2023. For the full year 2024, the net loss was $56.6 million, down from $67.9 million in 2023, reflecting a reduction in overall losses [45] Business Line Data and Key Metrics Changes - Contract revenue for Q4 2024 was approximately $1 million, with no contract revenue reported for the same period in 2023, indicating a new revenue stream [41] - Research and development expenses for Q4 2024 were $6.8 million, down from $7.6 million in Q4 2023. For the full year, R&D expenses decreased to $26.7 million from $39.6 million in 2023, attributed to cost containment measures [42] Market Data and Key Metrics Changes - The obesity market is projected to reach $100 billion by 2030, highlighting significant growth potential for oral alternatives in treatment [19] Company Strategy and Development Direction - The company aims to leverage its Ronnie Pill technology to develop next-generation obesity therapies, focusing on RT-114 and semaglutide programs [10][20] - A strategic partnership was established with Progen Co Limited for the co-development and commercialization of RT-114, combining their GLP-1, GLP-2 dual agonist with the Ronnie Pill [20][21] - The company is open to additional partnerships to advance oral biologics across various indications, including immunology and endocrinology [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the advancements made in the pipeline, particularly in the obesity space, and plans to bring RT-114 into clinical trials by mid-2025 [48] - The management highlighted the potential of the Ronnie Pill platform to redefine the treatment paradigm for injectable large molecule therapeutics [48] Other Important Information - The company has a robust patent portfolio with over 450 granted patents and pending applications, supporting its innovative delivery technology [15] Q&A Session Summary Question: Development of oral semaglutide and capital constraints - Management confirmed that the primary focus is on RT-114 due to capital constraints, and while RT-116 is a discovery program, it is not currently planned for clinical study [55][56] Question: Variability in weight loss with RT-114 - Management explained that the transenteric route has shown to be more efficient than subcutaneous delivery, leading to less variability in weight loss outcomes [70] Question: Tolerability and dosing flexibility for RT-114 - Management emphasized that tolerability is key and that the oral formulation allows for flexible dosing, which can be adjusted based on patient response [78][80] Question: Comparison of PG-102 with other GLP-1, GLP-2 therapies - Management noted that PG-102 has shown sustained weight loss over time compared to other therapies, and the FC fusion protein nature of PG-102 allows for rapid titration without the need for extensive dose adjustments [100] Question: Future studies for RT-114 - Management confirmed that no additional animal studies are planned before entering clinical trials, expressing confidence based on previous studies [104] Question: Regulatory pathway for PG-102 - Management indicated that Progen is moving forward with Phase 2A studies for PG-102 and plans to file an IND in the near future, which could benefit the RT-114 program [112]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission File Number: 001-40672 RANI THERAPEUTICS HOLDINGS, INC. (Exact Name of Registrant as Specified in its Charter) Delawa ...

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]