Rani Therapeutics (RANI)

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Rani Therapeutics (RANI) - 2025 Q2 - Quarterly Results
2025-08-07 20:07
[Second Quarter 2025 Financial Results and Corporate Update](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results%20and%20Corporate%20Update) This section summarizes Rani Therapeutics' Q2 2025 financial results, operational highlights, and strategic milestones [Overview and CEO Commentary](index=1&type=section&id=Overview%20and%20CEO%20Commentary) Rani Therapeutics reported Q2 2025 results, detailing a Chugai collaboration, RT-114 preclinical data, and planned Phase 1 trial initiation in H2 2025 - Announced strategic research collaboration with Chugai for two undisclosed molecules[1](index=1&type=chunk)[3](index=3&type=chunk) - 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[1](index=1&type=chunk)[3](index=3&type=chunk) - Phase 1 study for RT-114 for the treatment of obesity expected to initiate in the **second half of 2025**[1](index=1&type=chunk)[3](index=3&type=chunk) - Announced a warrant inducement transaction with an existing investor with gross proceeds of **$4.3 million**[1](index=1&type=chunk) - Announced pricing of **$3.0 million** registered direct offering[1](index=1&type=chunk) [Second Quarter 2025 Operational and Financing Highlights](index=1&type=section&id=Second%20Quarter%202025%20Highlights) Rani Therapeutics detailed Q2 2025 achievements: Chugai collaboration, RT-114 preclinical data for obesity, and successful capital raises - Strategic Research Collaboration with Chugai: RaniPill® delivery demonstrated comparable bioavailability to the subcutaneous route for two molecules[4](index=4&type=chunk) - Preclinical Data Presentation for RT-114: Oral delivery of a bispecific GLP-1/GLP-2 receptor agonist (PG-102) via RT-114 achieved bioequivalence to subcutaneous injection in canines, providing rationale for clinical development as a first-in-class oral anti-obesity therapy[4](index=4&type=chunk) Warrant Inducement Transaction | Detail | Amount | | :----- | :----- | | Gross Proceeds | **$4.3 million** | | Exercise Price | **$0.65 per share** | | New Series D Warrants | **13,160,172 shares** | Registered Direct Offering | Detail | Amount | | :----- | :----- | | Total Offering | **$3.0 million** | | Class A Common Stock | **4,354,000 shares @ $0.40/share** | | Pre-funded Warrants | **3,146,000 shares @ $0.3999/share** | [Near-Term Milestone Expectations](index=2&type=section&id=Near-Term%20Milestone%20Expectations) Rani Therapeutics expects to initiate a Phase 1 clinical trial for RT-114 for obesity in H2 2025 - Initiation of Phase 1 clinical trial of RT-114 for the treatment of obesity expected in the **second half of 2025**[5](index=5&type=chunk) [Company Information](index=2&type=section&id=Company%20Information) This section outlines Rani Therapeutics' core business, proprietary technology, and development focus [About Rani Therapeutics](index=2&type=section&id=About%20Rani%20Therapeutics) Rani Therapeutics is a clinical-stage biotherapeutics company developing orally administered biologics with its proprietary RaniPill® capsule - Clinical-stage biotherapeutics company focused on advancing technologies for orally administered biologics and drugs[7](index=7&type=chunk) - Developed the RaniPill® capsule, a novel, proprietary, and patented platform technology intended to replace subcutaneous injection or intravenous infusion with oral dosing[7](index=7&type=chunk) - Successfully conducted several preclinical and clinical studies to evaluate safety, tolerability, and bioavailability using RaniPill® capsule technology[7](index=7&type=chunk) [Second Quarter 2025 Financial Results](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Results) This section outlines Rani Therapeutics' Q2 2025 financial results, including key metrics, balance sheet, and statements of operations [Key Financial Highlights (Narrative)](index=2&type=section&id=Key%20Financial%20Highlights%20(Narrative)) Rani Therapeutics reported a Q2 2025 net loss of **$11.2 million** and reduced operating expenses, reflecting an improved net loss year-over-year Key Financial Highlights | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) (in millions) | Primary Reason for Change | | :----- | :----- | :----- | :----- | :----- | | Cash, cash equivalents & marketable securities (as of period end) | **$10.2** (June 30, 2025) | **$27.6** (Dec 31, 2024) | **-$17.4** | N/A | | Research and development expenses | **$5.5** | **$6.1** | **-$0.6** | Lower compensation costs | | General and administrative expenses | **$5.0** | **$6.4** | **-$1.4** | Lower compensation costs ($0.5M), reduction in third-party services ($0.6M), other services ($0.3M) | | Net loss | **$(11.2)** | **$(13.4)** | **+$2.2** (improvement) | N/A | | Stock-based compensation expense (included in Net Loss) | **$3.3** | **$4.1** | **-$0.8** | N/A | [Condensed Consolidated Balance Sheets](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Total assets decreased to **$16.9 million** as of June 30, 2025, from **$36.6 million** at year-end 2024, primarily due to reduced marketable securities Condensed Consolidated Balance Sheets | Item | June 30, 2025 (Unaudited) (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | | :------------------ | :------------------------ | :---------------- | :----- | | Cash and cash equivalents | **$10,216** | **$3,762** | **+$6,454** | | Marketable securities | **$—** | **$23,877** | **-$23,877** | | Total current assets | **$11,073** | **$29,744** | **-$18,671** | | Total assets | **$16,898** | **$36,634** | **-$19,736** | | Total current liabilities | **$20,623** | **$19,891** | **+$732** | | Total liabilities | **$26,051** | **$33,141** | **-$7,090** | | Total stockholders' (deficit)/equity | **$(9,153)** | **$3,493** | **-$12,646** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) For Q2 2025, Rani Therapeutics reported a net loss of **$11.2 million** and reduced operating expenses, reflecting an improved net loss year-over-year Condensed Consolidated Statements of Operations (Three Months Ended June 30) | Item | 2025 (Unaudited) (in thousands) | 2024 (Unaudited) (in thousands) | Change (YoY) (in thousands) | | :---------------------------------- | :--------------- | :--------------- | :----------- | | Contract revenue | **$—** | **$—** | **$0** | | Research and development | **$5,505** | **$6,115** | **-$610** | | General and administrative | **$5,000** | **$6,409** | **-$1,409** | | Total operating expenses | **$10,505** | **$12,524** | **-$2,019** | | Loss from operations | **$(10,505)** | **$(12,524)** | **+$2,019** | | Net loss | **$(11,224)** | **$(13,361)** | **+$2,137** | | Net loss attributable to Rani Therapeutics Holdings, Inc. | **$(6,692)** | **$(6,805)** | **+$113** | | Net loss per Class A common share, basic and diluted | **$(0.18)** | **$(0.26)** | **+$0.08** | | Weighted-average Class A common shares outstanding | **36,542** | **26,324** | **+10,218** | Condensed Consolidated Statements of Operations (Six Months Ended June 30) | Item | 2025 (Unaudited) (in thousands) | 2024 (Unaudited) (in thousands) | Change (YoY) (in thousands) | | :---------------------------------- | :--------------- | :--------------- | :----------- | | Contract revenue | **$172** | **$—** | **+$172** | | Research and development | **$12,075** | **$13,700** | **-$1,625** | | General and administrative | **$10,615** | **$12,857** | **-$2,242** | | Total operating expenses | **$22,690** | **$26,557** | **-$3,867** | | Loss from operations | **$(22,518)** | **$(26,557)** | **+$4,039** | | Net loss | **$(23,962)** | **$(28,140)** | **+$4,178** | | Net loss attributable to Rani Therapeutics Holdings, Inc. | **$(13,956)** | **$(14,288)** | **+$332** | | Net loss per Class A common share, basic and diluted | **$(0.40)** | **$(0.55)** | **+$0.15** | | Weighted-average Class A common shares outstanding | **34,999** | **26,179** | **+8,820** | [Legal and Contact Information](index=2&type=section&id=Legal%20and%20Contact%20Information) This section outlines cautionary statements regarding future performance and provides essential investor and media contact information [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) This section outlines cautionary statements regarding future events, emphasizing that actual results may differ materially due to risks - Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995[8](index=8&type=chunk) - Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties[8](index=8&type=chunk) - Rani undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law[8](index=8&type=chunk)[10](index=10&type=chunk) [Investor and Media Contacts](index=3&type=section&id=Investor%20Contact) Provides contact details for investor relations and media inquiries for Rani Therapeutics - Investor Contact: **investors@ranitherapeutics.com**[11](index=11&type=chunk) - Media Contact: **media@ranitherapeutics.com**[11](index=11&type=chunk)
Rani Therapeutics Reports Second Quarter 2025 Financial Results; Provides Corporate Update
Globenewswire· 2025-08-07 20:05
Core Insights - Rani Therapeutics announced a strategic research collaboration with Chugai for two undisclosed molecules, which may evolve into a long-term partnership focused on oral biologic therapies for chronic diseases [2][7] - The company presented preclinical data for its oral bispecific GLP-1/GLP-2 receptor agonist, RT-114, at ENDO 2025, showing bioequivalence to subcutaneous injections in canines, indicating its potential to transform obesity treatment [2][6] - Rani Therapeutics reported a net loss of $11.2 million for Q2 2025, a decrease from $13.4 million in Q2 2024, reflecting improved financial management [10][14] Financial Results - As of June 30, 2025, Rani Therapeutics had cash, cash equivalents, and marketable securities totaling $10.2 million, down from $27.6 million at the end of 2024 [5] - Research and development expenses for Q2 2025 were $5.5 million, a decrease from $6.1 million in Q2 2024, primarily due to lower compensation costs [10][14] - General and administrative expenses for Q2 2025 were $5.0 million, down from $6.4 million in Q2 2024, attributed to reduced compensation and third-party service costs [10][14] Upcoming Milestones - The initiation of a Phase 1 clinical trial for RT-114, targeting obesity treatment, is expected in the second half of 2025 [4][6] - The company has entered into a $3.0 million registered direct offering for the sale of Class A common stock, indicating ongoing efforts to secure funding [6][7]
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 and ProGen Announce Late Breaking Presentation at ENDO 2025 Demonstrating Bioequivalence of Novel, Bispecific GLP-1/GLP-2 Receptor Agonist Delivered Orally via RaniPill Compared to Subcutaneous Delivery
GlobeNewswire News Room· 2025-07-14 09:00
Details of the presentations are as follows: Abstract Title: Oral Delivery of a Bispecific GLP-1/GLP-2 Receptor Agonist (PG-102) via a Robotic Pill (RT- 114) Achieves Bioequivalence to Subcutaneous Injection in Canines Session Type: Poster Presentation Session Title: Adipose Tissue, Appetite, and Obesity: From Breakthroughs to Real-World Challenges: Navigating Weight Loss, Regain, and Therapeutic Advances II Session Date & Time: July 14, 2025 from 12:00 PM to 1:30 PM PT Poster Number: MON-691 SAN JOSE, Cali ...
Rani Therapeutics and ProGen Announce Late Breaking Presentation at ENDO 2025 Demonstrating Bioequivalence of Novel, Bispecific GLP-1/GLP-2 Receptor Agonist Delivered Orally via RaniPill Compared to Subcutaneous Delivery
Globenewswire· 2025-07-14 09:00
SAN JOSE, Calif., July 14, 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 announced that it will present preclinical data on the RaniPill® capsule at the Endocrine Society's Annual Meeting (ENDO 2025) taking place July 12-15 in San Francisco, CA. Details of the presentations are as follows: Abstract Title: Oral Delivery of a Bispecific GLP-1/GLP-2 Rec ...
Rani Therapeutics Announces Research Agreement with Chugai
Globenewswire· 2025-05-19 12:00
- Research agreement is evaluating feasibility of applying Rani's oral delivery technology to Chugai's antibodies against undisclosed targets - SAN JOSE, Calif., May 19, 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 announced the company has entered into a Research Agreement on 13 August, 2024, for two molecules with undisclosed targets provided by C ...
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
[First Quarter 2025 Corporate Update](index=1&type=section&id=First%20Quarter%202025%20Corporate%20Update) 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](index=1&type=section&id=Executive%20Summary) 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](index=1&type=chunk)[7](index=7&type=chunk) - 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](index=1&type=chunk)[2](index=2&type=chunk) - Phase 1 study for RT-114 for the treatment of obesity is expected to initiate in **mid-2025**[1](index=1&type=chunk)[2](index=2&type=chunk)[4](index=4&type=chunk) - 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](index=1&type=chunk)[6](index=6&type=chunk) [Preclinical Data Achievements](index=1&type=section&id=Preclinical%20Data%20Achievements) 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](index=6&type=chunk) - 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](index=6&type=chunk) [Near-Term Milestone Expectations](index=1&type=section&id=Near-Term%20Milestone%20Expectations) 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](index=4&type=chunk) [Financial Highlights](index=1&type=section&id=Financial%20Highlights) 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](index=6&type=chunk) - 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](index=9&type=chunk) - Net loss for both periods included non-cash stock-based compensation expense of **$3.9 million**[9](index=9&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) 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](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=11&type=chunk) [Condensed Consolidated Statements of Operations](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=2&type=section&id=Company%20Information) This section provides an overview of Rani Therapeutics, outlines forward-looking statements, and lists contact information for investor and media inquiries [About Rani Therapeutics](index=2&type=section&id=About%20Rani%20Therapeutics) 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](index=7&type=chunk) - 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](index=7&type=chunk) - RaniPill® capsule technology has been evaluated in several preclinical and clinical studies for safety, tolerability, and bioavailability[7](index=7&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) 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](index=8&type=chunk) - Actual results may differ materially from forward-looking statements due to various risks and uncertainties, including those described in Rani's SEC filings[8](index=8&type=chunk) - Rani Therapeutics does not undertake any obligation to update forward-looking statements, except as required by law[8](index=8&type=chunk) [Contact Information](index=2&type=section&id=Contact%20Information) This section provides contact details for investor and media inquiries - Investor contact email: **investors@ranitherapeutics.com**[9](index=9&type=chunk) - Media contact email: **media@ranitherapeutics.com**[9](index=9&type=chunk)
Rani Therapeutics Reports First Quarter 2025 Financial Results; Provides Corporate Update
Globenewswire· 2025-05-13 20:05
Core Insights - Rani Therapeutics announced promising preclinical data for RT-114, a bispecific GLP-1/GLP-2 receptor agonist, demonstrating bioequivalence to subcutaneous administration when delivered orally via the RaniPill® capsule [1][7] - The company plans to initiate a Phase 1 clinical trial for RT-114 targeting obesity in mid-2025 [4] - Financial results for Q1 2025 show a net loss of $12.7 million, an improvement from a net loss of $14.8 million in Q1 2024 [5][13] Preclinical Developments - Preclinical studies indicated that RT-114 achieved a relative bioavailability of 111% compared to subcutaneously administered PG-102, with similar pharmacokinetic profiles [7] - Successful oral delivery of semaglutide via the RaniPill® capsule was also reported, showing comparable bioavailability and weight loss to subcutaneous administration [7] Financial Performance - As of March 31, 2025, cash, cash equivalents, and marketable securities totaled $15.9 million, down from $27.6 million at the end of 2024 [7] - Contract revenue for Q1 2025 was $0.2 million, a new revenue stream compared to no contract revenue in Q1 2024 [7] - Research and development expenses decreased to $6.6 million from $7.6 million in the same period last year, primarily due to lower compensation costs [7] Company Overview - Rani Therapeutics is focused on the oral delivery of biologics and drugs, utilizing the RaniPill® capsule technology to replace traditional subcutaneous injections [8] - The company aims to make oral biologics a reality for patients, particularly those living with obesity [2]
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 ...