Rani Therapeutics (RANI)

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Rani Therapeutics (RANI) - 2025 Q2 - Quarterly Report
2025-08-07 20:15
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 June 30, 2025 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) De ...
Rani Therapeutics (RANI) - 2025 Q2 - Quarterly Results
2025-08-07 20:07
Exhibit 99.1 Rani Therapeutics Reports Second Quarter 2025 Financial Results; Provides Corporate Update – Presented preclinical data demonstrating bioequivalence of novel, bispecific GLP-1/GLP-2 receptor agonist delivered orally via RaniPill (RT-114) compared to subcutaneous delivery at ENDO 2025 – – Phase 1 study for RT-114 for the treatment of obesity expected to initiate in the second half of 2025 – – Announced a warrant inducement transaction with an existing investor with gross proceeds of $4.3 million ...
Rani Therapeutics Reports Second Quarter 2025 Financial Results; Provides Corporate Update
Globenewswire· 2025-08-07 20:05
– Announced strategic research collaboration with Chugai for two undisclosed molecules – – Presented preclinical data demonstrating bioequivalence of novel, bispecific GLP-1/GLP-2 receptor agonist delivered orally via RaniPill (RT-114) compared to subcutaneous delivery at ENDO 2025 – – Phase 1 study for RT-114 for the treatment of obesity expected to initiate in the second half of 2025 – – Announced a warrant inducement transaction with an existing investor with gross proceeds of $4.3 million – – Announced ...
Rani Therapeutics Holdings, Inc. Announces Pricing of $3.0 Million Registered Direct Offering
GlobeNewswire News Room· 2025-07-15 13:00
Group 1 - Rani Therapeutics has entered into a securities purchase agreement for the sale of 4,354,000 shares of Class A common stock at $0.40 per share and pre-funded warrants for 3,146,000 shares at $0.3999 per share [1][2] - The offering is expected to close on or about July 16, 2025, with gross proceeds estimated at approximately $3.0 million before deducting fees and expenses [2] - The securities are being offered under a "shelf" registration statement declared effective by the SEC on August 10, 2022, and a final prospectus supplement will be filed with the SEC [3] Group 2 - Rani Therapeutics is a clinical-stage biotherapeutics company focused on oral delivery technologies for biologics and drugs, including the RaniPill® capsule [4] - The RaniPill® capsule is designed to replace subcutaneous injections or intravenous infusions with oral dosing, and the company has conducted several studies to evaluate its safety and bioavailability [4]
Rani Therapeutics (RANI) - 2025 Q1 - Quarterly Report
2025-05-13 20:15
[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company reported its first revenue and a reduced net loss in Q1 2025 but faces a stockholders' deficit and a going concern qualification [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased while liabilities remained stable, shifting the company from stockholders' equity to a deficit position by March 31, 2025 Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $10,111 | $3,762 | | Marketable securities | $5,742 | $23,877 | | **Total Assets** | **$24,125** | **$36,634** | | Total current liabilities | $20,130 | $19,891 | | **Total Liabilities** | **$29,474** | **$33,141** | | **Total stockholders' (deficit)/equity** | **($5,349)** | **$3,493** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company generated its first contract revenue in Q1 2025, and reduced operating expenses led to a smaller net loss compared to the prior year Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share amounts) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Contract revenue | $172 | $0 | | Research and development | $6,570 | $7,586 | | General and administrative | $5,615 | $6,448 | | **Total operating expenses** | **$12,185** | **$14,034** | | Loss from operations | ($12,013) | ($14,034) | | **Net loss** | **($12,738)** | **($14,779)** | | Net loss per Class A share | ($0.22) | ($0.29) | [Condensed Consolidated Statements of Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) The comprehensive loss for Q1 2025 decreased year-over-year, primarily reflecting the lower net loss for the period Comprehensive Loss Summary (in thousands) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net loss | $(12,738) | $(14,779) | | Comprehensive loss | $(12,744) | $(14,778) | [Condensed Consolidated Statements of Changes in Stockholders' (Deficit)/Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20(Deficit)%2FEquity) Stockholders' equity turned into a deficit during Q1 2025, driven primarily by the quarterly net loss - The company's equity position shifted from a positive **$3.5 million** at the end of 2024 to a deficit of **$5.3 million** by the end of Q1 2025, mainly due to the quarterly net loss[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The company saw improved operating cash flow and a net cash increase in Q1 2025, largely due to proceeds from maturing marketable securities Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,149) | $(9,402) | | Net cash provided by investing activities | $18,229 | $10,294 | | Net cash (used in)/provided by financing activities | $(3,731) | $121 | | **Net increase in cash** | **$6,349** | **$1,013** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Key notes disclose a going concern doubt, the company's first revenue contract, a new collaboration, and total long-term debt - The company has incurred recurring losses, with a net loss of **$12.7 million** for Q1 2025 and an accumulated deficit of **$110.2 million**, leading management to conclude there is **substantial doubt about the company's ability to continue as a going concern** for the next year[27](index=27&type=chunk) - In August 2024, the company entered into an evaluation services contract with a customer for a total of **$1.2 million**, recognizing **$0.2 million** in revenue for the period ended March 31, 2025[44](index=44&type=chunk) - In June 2024, the company entered into a collaboration agreement with ProGen Co, Ltd to develop and commercialize a product combining ProGen's PG-102 with the RaniPill HC, with development costs and operating profits/losses to be **shared equally**[45](index=45&type=chunk)[46](index=46&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses positive preclinical data, reiterates substantial going concern doubt, and attributes the lower net loss to reduced compensation costs [Overview](index=23&type=section&id=Overview) The company is a clinical-stage biotherapeutics firm developing its RaniPill oral delivery platform, with recent positive preclinical data for two candidates - The company is developing two versions of its oral delivery platform: the RaniPill GO for microtablets and the high-capacity RaniPill HC for liquid payloads, with clinical testing for the HC version planned for **mid-2025**[82](index=82&type=chunk) - Preclinical data for RT-114 (oral PG-102) demonstrated **111% relative bioavailability** compared to subcutaneous injection, with comparable pharmacokinetics and weight loss[89](index=89&type=chunk) - Preclinical data for RT-116 (oral semaglutide) showed **comparable bioavailability**, pharmacokinetics, and weight loss to subcutaneous administration[90](index=90&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) The company recognized its first revenue in Q1 2025, while both R&D and G&A expenses decreased due to lower compensation costs Comparison of Operating Results (in thousands) | | Three Months Ended March 31, | | | |---|---|---|---| | | 2025 | 2024 | Change | | Contract revenue | $172 | $— | * % | | Research and development | $6,570 | $7,586 | (13.4)% | | General and administrative | $5,615 | $6,448 | (12.9)% | | **Total operating expenses** | **$12,185** | **$14,034** | **(13.2)%** | - The **$1.0 million decrease in R&D expenses** was primarily attributed to lower compensation costs[95](index=95&type=chunk) - The **$0.8 million decrease in G&A expenses** was mainly due to lower compensation costs ($0.4 million) and a reduction in third-party services ($0.5 million)[96](index=96&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company faces a critical liquidity shortage with substantial going concern doubt, as current cash is insufficient to fund operations beyond early August 2025 - There is **substantial doubt about the company's ability to continue as a going concern**, as existing capital resources of **$15.9 million** are not sufficient to fund operations for one year[98](index=98&type=chunk) - The company raised aggregate net proceeds of **$9.4 million** in October 2024 and **$8.9 million** in July 2024 through securities purchase agreements[99](index=99&type=chunk)[100](index=100&type=chunk) - The company will need to raise **substantial additional funds** to complete development of the RaniPill platform, advance product candidates, and expand manufacturing[105](index=105&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Rani Therapeutics is not required to provide the information for this item - The company is a **smaller reporting company** as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information under this item[123](index=123&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of the quarter's end, with no material changes to internal controls - Based on their evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were **effective at a reasonable assurance level** as of March 31, 2025[124](index=124&type=chunk) - **No changes in internal control over financial reporting** occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[125](index=125&type=chunk) [PART II. OTHER INFORMATION](index=32&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings that are expected to have a material adverse effect on its business - The company is **not currently involved in any litigation** or legal proceedings that management believes are likely to have a material adverse effect on the business[128](index=128&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) Key risks include substantial going concern doubt, a Nasdaq delisting notice, and reliance on international suppliers - There is **substantial doubt about the company's ability to continue as a going concern**, as existing cash of **$15.9 million** is not sufficient to meet operating needs beyond **early August 2025**[132](index=132&type=chunk)[133](index=133&type=chunk) - On May 1, 2025, the company received a notice from Nasdaq for **non-compliance with the minimum market value of listed securities ($50 million)** requirement, with a deadline of October 28, 2025, to regain compliance[142](index=142&type=chunk) - The company faces risks from international trade policies, tariffs, and sanctions, as it sources drug substances and raw materials from suppliers in **Korea and China**[144](index=144&type=chunk)[146](index=146&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[150](index=150&type=chunk) [Defaults Upon Senior Securities](index=35&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[151](index=151&type=chunk) [Mine Safety Disclosures](index=35&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[152](index=152&type=chunk) [Other Information](index=35&type=section&id=Item%205.%20Other%20Information) There was no other information to report for the period - None[153](index=153&type=chunk) [Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents and officer certifications
Rani Therapeutics (RANI) - 2025 Q1 - Quarterly Results
2025-05-13 20:10
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 ...
Rani Therapeutics Reports First Quarter 2025 Financial Results; Provides Corporate Update
Globenewswire· 2025-05-13 20:05
- 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 ...
Rani Therapeutics (RANI) - 2024 Q4 - Earnings Call Presentation
2025-03-31 23:14
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 ...
Rani Therapeutics (RANI) - 2024 Q4 - Earnings Call Transcript
2025-03-31 20:30
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]
Rani Therapeutics (RANI) - 2024 Q4 - Annual Report
2025-03-31 20:15
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 ...