Core Insights - Rani Therapeutics Holdings experienced a significant stock surge of 248% to close at $1.64 following a collaboration announcement with Chugai Pharmaceutical [1] - The stock has increased by 222% over the past month, primarily due to investor enthusiasm surrounding its RaniPill technology, which allows for oral delivery of biologic drugs [2] Collaboration Details - The partnership with Chugai Pharmaceutical aims to develop an oral formulation utilizing RaniPill technology and Chugai's rare disease antibody, with potential deal value exceeding $1 billion if all milestones are achieved [2][4] - Rani will receive an upfront payment of $10 million and is eligible for up to $75 million in technology transfer and development milestones [3] - Additional potential earnings include up to $100 million in sales milestones and single-digit royalties on future sales, with Chugai having the option to expand the partnership to include up to five additional drug targets [4] Financing and Investor Interest - Concurrently with the Chugai deal, Rani announced a $60.3 million private placement financing led by Samsara BioCapital, with participation from several notable investors [5] - Despite being classified as a penny stock, Rani has attracted attention from major institutional investors, including Vanguard Group and BlackRock, indicating a notable level of confidence in the company [5]

Company Developments - Rani Therapeutics Holdings, Inc. (RANI) experienced a significant price increase of 303.48% to $1.9, attributed to a licensing agreement with Chugai Pharmaceutical potentially worth up to $1.09 billion, involving an oral drug and possibly extending to five drugs [1][7] - Artiva Biotherapeutics, Inc. (ARTV) saw a 148.74% rise to $6.89, linked to the FDA granting Fast Track Designation for its AlloNK® development targeting refractory rheumatoid arthritis, with promising trial results showing consistent B-cell depletion and favorable safety profiles [2][7] - Sunshine Biopharma, Inc. (SBFMW) had a 71.22% increase to $0.29, driven by investor optimism regarding potential breakthroughs in its anticancer research [3][7] - NextPlat Corp (NXPLW) rose by 55.52% to $0.1, possibly reflecting new contracts or technological advancements in mobile satellite services, with expansion into new markets impacting its business model and revenue streams [4] - XORTX Therapeutics Inc. (XRTX) experienced a 52.35% increase to $1.29, due to acquiring a renal anti-fibrotic therapeutic program from Vectus Biosystems, enhancing its clinical programs [5] Market Trends - Recent market trends indicate notable price changes among several companies, reflecting various factors driving investor interest, underscoring the dynamic nature of the stock market [6]

Core Viewpoint - Rani Therapeutics' stock surged over 265% following a partnership announcement with Chugai Pharmaceutical, reaching a new high of $1.76 per share [1] Group 1: Partnership Details - The collaboration with Chugai Pharmaceutical is valued at up to $1.085 billion, including an upfront payment of $10 million [1] - Rani Therapeutics is eligible for up to $75 million in technology transfer and development milestone payments, $100 million in sales milestone payments, and single-digit royalties [1] - Chugai has the option to expand the partnership to five additional drug targets [1] Group 2: Company Overview - Rani Therapeutics specializes in oral delivery technology for biopharmaceuticals, with its core platform, RaniPill, focusing on oral antibodies and rare disease drug development [1] - The partnership aims to apply Rani's technology to Chugai's rare disease antibody projects, validating the application value of Rani's technology [1]

Core Viewpoint - Rani Therapeutics experienced a significant stock surge of over 265%, reaching a new annual high of $1.76, following the announcement of a collaboration agreement with Chugai Pharmaceutical worth up to $1.085 billion [1] Company Summary - Rani Therapeutics has entered into a collaboration agreement with Chugai Pharmaceutical, which includes an upfront payment of $10 million and potential milestone payments totaling up to $750 million for technology transfer and development, $100 million for sales milestones, and single-digit royalties [1] - The collaboration focuses on Rani Therapeutics' oral delivery technology for biologics, specifically utilizing its RaniPill® platform for the development of oral antibodies and treatments for rare diseases [1] - The partnership will apply to Chugai Pharmaceutical's rare disease antibody projects, validating the application value of Rani Therapeutics' technology [1]

Core Insights - Rani Therapeutics has entered into a significant Collaboration and License Agreement with Chugai Pharmaceutical, valued at up to $1.085 billion, focusing on the development of an oral product utilizing Rani's RaniPill technology and Chugai's antibody for rare diseases [4][5][6] Financial Details - The initial agreement includes a $10 million upfront payment, potential for up to $75 million in technology transfer and development milestones, and up to $100 million in sales milestones, along with single-digit royalties on product sales [5][7] - Rani also completed an oversubscribed private placement financing of $60.3 million, led by Samsara BioCapital and other notable investors [5][8] Strategic Importance - The partnership aims to address unmet medical needs in rare and immunologic diseases by providing oral therapies, which could enhance patient adherence and quality of life compared to traditional injection methods [6][7] - CEO Talat Imran emphasized the collaboration as a convergence of Rani's innovative technology and Chugai's expertise, targeting multiple disease areas with high unmet needs [6][7]

Core Insights - Rani Therapeutics has entered into a licensing agreement with Chugai Pharmaceutical for an oral drug, with the potential to extend the deal to five additional drugs, which could increase the total deal value to $1.09 billion [1] Company Summary - The agreement allows Chugai Pharmaceutical to license an oral drug developed by Rani Therapeutics [1] - The potential extension of the deal to five drugs indicates a significant opportunity for Rani Therapeutics to expand its market presence and revenue [1] Financial Implications - The total deal value of $1.09 billion highlights the financial significance of the partnership for Rani Therapeutics [1]

Core Viewpoint - Rani Therapeutics has announced a private placement of Class A common stock and accompanying warrants, expected to generate approximately $60.3 million in gross proceeds, aimed at funding operations into 2028 and advancing its RaniPill® platform [1][3][4] Private Placement Details - The private placement will involve the issuance of 42,633,337 shares of Class A common stock at a price of $0.48 per share and pre-funded warrants at $0.4799 per warrant, with an exercise price of $0.0001 per share for the pre-funded warrants [5] - The accompanying warrants will allow the purchase of up to 125,000,004 shares of Class A common stock at an exercise price of $0.48 per share, exercisable upon stockholder approval [5][6] Use of Proceeds - Net proceeds from the private placement, along with an upfront payment of $10 million and an expected $18 million technology transfer milestone from Chugai Pharmaceuticals, will support the company's operations and pipeline development through 2028 [3][4] Strategic Partnerships - The financing is seen as a pivotal moment for Rani, combining its oral delivery technology with Chugai's expertise in antibody development, aiming to create transformative oral therapies for rare diseases [4][12] Investor Participation - The private placement was led by Samsara BioCapital, with participation from other investors including RA Capital Management and Anomaly, and includes a provision for Samsara and Anomaly to designate board members [6][7][8] Debt Conversion - Avenue Venture Opportunities Fund will convert $6 million of outstanding debt into 12,500,000 shares of Class A common stock and receive warrants on the same terms as other investors, reducing the company's debt obligations [9]

Core Insights - Rani Therapeutics has entered into a collaboration and license agreement with Chugai Pharmaceutical for the development of an oral product utilizing Rani's RaniPill technology and Chugai's antibody for rare diseases [1][2] - The total potential deal value could exceed $1 billion if Chugai exercises options for additional drug targets [1][2] Financial Details - Rani will receive an upfront payment of $10 million and is eligible for up to $75 million in technology transfer and development milestones, as well as up to $100 million in sales milestones [1][2] - A private placement financing led by Samsara BioCapital is expected to yield approximately $60.3 million, which, along with other expected proceeds, will fund Rani's operations into 2028 [4] Strategic Importance - The partnership aims to combine Rani's oral delivery technology with Chugai's expertise in complex antibodies, addressing the need for less burdensome oral therapies for patients with high unmet medical needs [2][3] - Rani's technology is expected to transform the administration of biologics, traditionally limited to injections, thereby enhancing patient quality of life [3][7]

PART I. FINANCIAL INFORMATION This section presents the unaudited financial statements, management's analysis, market risk disclosures, and controls for the period [Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited financials reveal a **$24.0 million net loss**, **$116.9 million accumulated deficit**, and **$9.2 million stockholders' deficit**, raising going concern doubts - The company has incurred recurring losses, including a net loss of **$24.0 million** for the six months ended June 30, 2025, and had an accumulated deficit of **$116.9 million**. As of June 30, 2025, cash, cash equivalents, and marketable securities totaled **$10.2 million**[32](index=32&type=chunk) - Management has concluded that based on available cash and the current operating plan, there is substantial doubt about the company's ability to continue as a going concern for one year after the financial statement issuance date[32](index=32&type=chunk)[33](index=33&type=chunk) Condensed Consolidated Balance Sheet Summary (in thousands) | Account | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $10,216 | $3,762 | | Marketable securities | $0 | $23,877 | | Total current assets | $11,073 | $29,744 | | Total assets | $16,898 | $36,634 | | **Liabilities & Equity** | | | | Total current liabilities | $20,623 | $19,891 | | Total liabilities | $26,051 | $33,141 | | Total stockholders' (deficit)/equity | ($9,153) | $3,493 | Condensed Consolidated Statements of Operations Summary (in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Contract revenue | $172 | $0 | | Research and development | $12,075 | $13,700 | | General and administrative | $10,615 | $12,857 | | Loss from operations | ($22,518) | ($26,557) | | Net loss | ($23,962) | ($28,140) | | Net loss per Class A share | ($0.40) | ($0.55) | Condensed Consolidated Statements of Cash Flows Summary (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($13,945) | ($18,431) | | Net cash provided by investing activities | $23,942 | $16,819 | | Net cash (used in)/provided by financing activities | ($3,543) | $262 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses severe liquidity, **going concern doubts**, Nasdaq non-compliance, and positive preclinical data - The company's existing capital resources are insufficient to initiate pivotal clinical trials, and there is substantial doubt about its ability to continue as a going concern for one year. Cash resources are not expected to be sufficient to meet operating needs beyond late September 2025 without additional funding[130](index=130&type=chunk)[173](index=173&type=chunk) - The company received non-compliance notices from Nasdaq for failing to meet the minimum bid price requirement of **$1.00 per share** and the minimum Market Value of Listed Securities (MVLS) of **$50 million**[114](index=114&type=chunk) - Recent financing activities include raising net proceeds of **$3.9 million** in May 2025 from a warrant exercise and gross proceeds of **$3.0 million** in July 2025 from a securities purchase agreement[111](index=111&type=chunk)[112](index=112&type=chunk) - Positive preclinical data was announced, demonstrating bioequivalence of orally delivered RT-114 (bispecific GLP-1/GLP-2 agonist) to subcutaneous injection, and successful oral delivery of semaglutide (GLP-1 agonist) via the RaniPill HC[116](index=116&type=chunk)[118](index=118&type=chunk) Comparison of Operating Expenses (in thousands) | Expense Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $12,075 | $13,700 | (11.9)% | | General and administrative | $10,615 | $12,857 | (17.4)% | | **Total operating expenses** | **$22,690** | **$26,557** | **(14.6)%** | [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is not required to provide the information for this item - As a smaller reporting company defined by Rule 12b-2 of the Exchange Act, the company is not required to provide quantitative and qualitative disclosures about market risk[162](index=162&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2025, with no material changes to internal controls - Based on an evaluation as of June 30, 2025, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[163](index=163&type=chunk) - There were no changes in internal control over financial reporting during the three months ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[164](index=164&type=chunk) PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, and other disclosures [Legal Proceedings](index=34&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[168](index=168&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) Critical risks include **going concern doubts**, potential Nasdaq delisting, and international trade and supply chain disruptions - There is substantial doubt about the company's ability to continue as a going concern. Existing cash of **$10.2 million** as of June 30, 2025, is not sufficient to meet operating needs beyond late September 2025, and failure to raise additional capital could lead to ceasing operations or bankruptcy[170](index=170&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk) - The company does not meet Nasdaq's continued listing requirements for minimum bid price and minimum market value of listed securities (MVLS), creating a risk of delisting, which would negatively impact stock liquidity and the ability to raise capital[181](index=181&type=chunk)[182](index=182&type=chunk)[183](index=183&type=chunk) - A new risk factor has been added regarding international trade policies, including tariffs and sanctions, which could adversely affect the business by increasing costs and disrupting the supply chain for raw materials and drug substances sourced from countries like China and Korea[186](index=186&type=chunk)[187](index=187&type=chunk)[188](index=188&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=38&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 reported[192](index=192&type=chunk) [Defaults Upon Senior Securities](index=38&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None reported[193](index=193&type=chunk) [Mine Safety Disclosures](index=38&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[194](index=194&type=chunk) [Other Information](index=38&type=section&id=Item%205.%20Other%20Information) The Board approved a cash retention program for executive officers and key employees on August 1, 2025 - On August 1, 2025, the Board approved a retention program for certain executive officers and key employees, providing cash payments equal to four months of their respective annual salaries[195](index=195&type=chunk) [Exhibits](index=39&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the report, including certifications by the Principal Executive and Financial Officers

[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)