UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the ...

Exhibit 99.1 Rani Therapeutics Reports First Quarter 2025 Financial Results; Provides Corporate Update First Quarter 2025 Highlights: Near-Term Milestone Expectations: • Initiation of Phase 1 clinical trial of RT-114 for the treatment of obesity expected in mid-2025. First Quarter 2025 Financial Results: • Preclinical data demonstrating bioequivalence of RT-114, a bispecific GLP-1/GLP-2 receptor agonist (PG-102) delivered orally via the RaniPill® capsule, to subcutaneously administered PG-102. In March 2025 ...

- Announced preclinical data demonstrating the bioequivalence of RT-114, a bispecific GLP-1/GLP-2 receptor agonist (PG-102), delivered orally via the RaniPill® capsule, to subcutaneous administration of PG-102 - - Phase 1 study for RT-114 for the treatment of obesity expected to initiate in mid-2025 - - Announced preclinical data demonstrating successful oral delivery of semaglutide via RaniPill® capsule - SAN JOSE, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutic ...

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 - 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]