Core Viewpoint - Rani Therapeutics Holdings, Inc. is set to release its financial results for Q4 and the full year of 2024 on March 31, 2025, along with a business update [1] Group 1: Financial Results Announcement - Rani Therapeutics will announce its financial results for the fourth quarter and full year ended December 31, 2024 [1] - The announcement will take place after the close of trading on March 31, 2025 [1] - A conference call and webcast will be hosted by Rani's management team at 4:30 p.m. ET on the same day [2] Group 2: Company Overview - Rani Therapeutics is a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs [3] - The company has developed the RaniPill® capsule, a proprietary technology aimed at replacing subcutaneous injections or intravenous infusions with oral dosing [3] - Rani has successfully conducted several preclinical and clinical studies to evaluate the safety, tolerability, and bioavailability of its RaniPill® capsule technology [3]

Core Insights - Rani Therapeutics has demonstrated that oral semaglutide via the RaniPill® HC (RT-116) shows comparable bioavailability, pharmacokinetics, and weight loss effects to subcutaneous administration [1][3][9] - The RaniPill platform is gaining recognition for its potential to facilitate oral delivery of various obesity treatments, with plans for a Phase 1 study of RT-114, a GLP-1/GLP-2 dual agonist, expected to start in 2025 [1][10] Company Overview - Rani Therapeutics is a clinical-stage biotherapeutics company focused on developing technologies for the oral delivery of biologics and drugs, specifically through the RaniPill capsule [11] - The company aims to replace subcutaneous injections with oral dosing, enhancing patient convenience and adherence [11] Product Details - Semaglutide, a GLP-1 receptor agonist, mimics the activity of the GLP-1 hormone, which regulates appetite and food intake [2] - Currently, semaglutide is available only as a subcutaneous injection marketed as WEGOVY, with global sales of approximately $3.1 billion in the first half of 2024 [3][4] Study Findings - In a preclinical study, semaglutide was successfully delivered in 7 of 8 canines using the RaniPill capsule, showing comparable pharmacokinetic and pharmacodynamic profiles to subcutaneous administration [6][7] - The relative bioavailability of oral semaglutide was found to be 107% compared to subcutaneous administration, with both methods resulting in similar weight loss and reductions in serum triglycerides and cholesterol [9] Future Prospects - The company is optimistic about the potential of a once-weekly oral version of semaglutide to transform obesity treatment, providing a more convenient option for patients [4][3] - The initiation of the Phase 1 clinical trial for RT-114 is anticipated in 2025, further expanding Rani's obesity treatment portfolio [10]

Financial Performance - Net loss for the three months ended September 30, 2024, was $12,722 thousand, compared to a net loss of $18,332 thousand for the same period in 2023, reflecting a reduction of approximately 30%[7] - The company reported a net loss attributable to Rani Therapeutics Holdings, Inc. of $6,783 thousand for the three months ended September 30, 2024, compared to $9,197 thousand for the same period in 2023, a decrease of approximately 26%[7] - For the nine months ended September 30, 2024, the company reported a net loss of $40.9 million, compared to a net loss of $53.8 million for the same period in 2023, representing a 24.5% improvement[11] - The net loss for the quarter ending September 30, 2024, is $12,722,000, compared to a net loss of $14,779,000 for the previous quarter[9] - The net loss attributable to Rani Therapeutics Holdings, Inc. for the nine months ended September 30, 2024, was $21.1 million, resulting in a net loss per Class A common share of $(0.78)[45] - The company expects to continue incurring losses for the foreseeable future and will need to raise substantial capital to complete the development of the RaniPill platform[51] Revenue and Expenses - Total revenue for the three months ended September 30, 2024, was $6,172,000, a decrease of 45.0% compared to $11,220,000 for the same period in 2023[53] - Research and development expenses for the three months ended September 30, 2024, were $6,172 thousand, down from $11,220 thousand in the same period of 2023, a decrease of about 45%[7] - Total operating expenses for the nine months ended September 30, 2024, were $38,356 thousand, compared to $52,665 thousand for the same period in 2023, a reduction of approximately 27%[7] - Research and development expenses for the nine months ended September 30, 2024, totaled $19,872,000, down 37.9% from $32,018,000 in 2023[55] - General and administrative expenses decreased by $2.2 million to $18,484,000 for the nine months ended September 30, 2024, a reduction of 10.5% compared to $20,647,000 in 2023[55] - General and administrative expenses for the three months ended September 30, 2024, were $41,000, down from $87,000 for the same period in 2023, indicating a reduction of 52.9%[32] Assets and Liabilities - Total current assets decreased from $50,847 thousand as of December 31, 2023, to $32,371 thousand as of September 30, 2024, representing a decline of approximately 36%[6] - Total liabilities increased from $32,473 thousand as of December 31, 2023, to $37,765 thousand as of September 30, 2024, an increase of about 16%[6] - The total stockholders' equity attributable to Rani Therapeutics Holdings, Inc. decreased from $12,866 thousand as of December 31, 2023, to $3,120 thousand as of September 30, 2024, a decline of about 76%[6] - As of September 30, 2024, total stockholders' equity is $5,775,000, a decrease from $14,535,000 as of March 31, 2024[9] - The accumulated deficit increased to $93,960,000 as of September 30, 2024, from $80,372,000 at March 31, 2024[9] Cash Flow - Cash and cash equivalents decreased from $5,864 thousand as of December 31, 2023, to $4,277 thousand as of September 30, 2024, a decline of about 27%[6] - The company had negative cash flows from operations of $26.8 million for the nine months ended September 30, 2024, an improvement from negative cash flows of $38.8 million in the prior year[12] - Net cash provided by investing activities for the nine months ended September 30, 2024 was $17.3 million, primarily from $57.3 million in proceeds from maturities of marketable securities[65] - Net cash provided by financing activities for the nine months ended September 30, 2024 was $8.0 million, mainly from net proceeds of $8.9 million from the July Offering[65] Funding and Capital Needs - The company expects to continue generating operating losses and negative cash flows as it develops the RaniPill capsule, indicating a need for substantial additional funding in the future[13] - The company anticipates needing to raise substantial additional capital to fund ongoing operations and development activities, with existing resources deemed insufficient for the next twelve months[61] - The company may seek additional capital through equity offerings or debt financings, but restrictions from recent agreements could limit these options[61] - The company entered into a Controlled Equity Sales Agreement allowing it to offer and sell up to $150 million of Class A common stock, but has not made any sales under this agreement as of September 30, 2024[13] Strategic Initiatives - The company aims to advance product candidates and expand its platform technology, focusing on the development of the RaniPill HC and other future designs[5] - The Company entered into a Collaboration Agreement with ProGen Co., Ltd. in June 2024 to develop a weight management product, sharing development costs and operating profits equally[28] - The Company will lead the development of the weight management product in the U.S., Canada, Europe, and Australia, while ProGen will handle development in other countries[28] - The company plans to initiate clinical testing of the RaniPill HC in 2025, which is intended to deliver drug payloads up to 200µL in liquid form[49] Accounting and Compliance - The company is evaluating the impact of recently issued accounting pronouncements, including ASU 2023-07 and ASU 2023-09, on its financial statements[23] - The company recognizes revenue based on actual costs incurred as a percentage of total estimated costs, reflecting a cost-based input method for contract revenue recognition[21] - The company had no contract assets recorded as of September 30, 2024, indicating no unconditional right to consideration[22] - The company had deferred revenue of $0.6 million related to unsatisfied evaluation services as of September 30, 2024, compared to no deferred revenue as of December 31, 2023[22] Legal and Governance - The company is not currently involved in any litigation that is likely to materially affect its business[71] - Management believes that disclosure controls provide reasonable assurance but cannot guarantee detection of all errors or fraud[70] - The effectiveness of control systems is limited by resource constraints and the cost-benefit analysis of controls[70] - Inherent limitations in control systems may lead to undetected misstatements due to error or fraud[70]

Financial Performance - Net loss for Q3 2024 was $12.7 million, compared to $18.3 million for the same period in 2023, showing an improvement[5][9] - Net loss attributable to Rani Therapeutics Holdings, Inc. for Q3 2024 was $6.8 million, compared to $9.2 million in Q3 2023[9] - General and administrative expenses for Q3 2024 were $5.6 million, down from $6.6 million in Q3 2023, reflecting a decrease of $1.0 million[5][9] - Research and development expenses for Q3 2024 were $6.2 million, a decrease of $5.0 million compared to $11.2 million in Q3 2023[5][9] Cash and Liquidity - Completed two equity offerings with total gross proceeds of approximately $20.0 million, extending cash runway into Q3 2025[1][3] - Cash, cash equivalents, and marketable securities as of September 30, 2024, totaled $30.4 million, down from $48.5 million at the end of 2023[4] - Total liabilities as of September 30, 2024, were $37.8 million, an increase from $32.5 million at the end of 2023[8] Clinical Development - Initiation of Phase 1 clinical trial of RT-114, a GLP-1/GLP-2 dual agonist for obesity treatment, is expected in 2025[4][2] - New preclinical pharmacokinetic data supports transenteric delivery of GLP-1 incretin triagonist, enhancing the potential of the RaniPill® platform[2][3] Shareholder Information - Weighted-average Class A common shares outstanding for Q3 2024 were 28,836, up from 25,552 in Q3 2023[9]

Group 1 - Rani Therapeutics has entered into a securities purchase agreement for the sale of 3,000,000 shares of Class A common stock and pre-funded warrants to purchase 333,333 shares, along with Series C common warrants for a total of 3,333,333 shares at a combined price of $3.00 per share [1][2] - The gross proceeds from this offering are expected to be approximately $10.0 million before deducting fees and expenses [3] - The offering is expected to close on or about October 16, 2024, subject to customary closing conditions [3] Group 2 - The Series A common warrants, which allowed for the purchase of 3,246,753 shares, will be canceled and are no longer exercisable [2] - The securities are being offered under a "shelf" registration statement declared effective by the SEC on August 10, 2022 [4] - Rani Therapeutics focuses on the oral delivery of biologics and drugs, utilizing its proprietary RaniPill® capsule technology to replace subcutaneous injections or intravenous infusions [6]

Core Insights - Rani Therapeutics Holdings, Inc. is a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs [3] - The company will participate in a fireside chat at the 2024 Maxim Healthcare Virtual Summit on October 17, 2024 [1] Company Overview - Rani Therapeutics has developed the RaniPill® capsule, a proprietary platform technology aimed at replacing subcutaneous injection or intravenous infusion with oral dosing [3] - The company has successfully conducted several preclinical and clinical studies to evaluate the safety, tolerability, and bioavailability of the RaniPill® capsule technology [3]

Core Viewpoint - Rani Therapeutics is actively engaging with investors through participation in two upcoming conferences in September 2024, showcasing its innovative oral delivery technology for biologics and drugs [1][2]. Group 1: Upcoming Conferences - Rani Therapeutics will participate in the H.C. Wainwright 26th Annual Global Investment Conference on September 10, 2024, at 4:30 pm E.T. at the Lotte New York Palace Hotel, with CEO Talat Imran presenting [1]. - The company will also be featured at the 2024 Cantor Global Healthcare Conference on September 18, 2024, at 11:30 am E.T. at the InterContinental Barclay Hotel, again with CEO Talat Imran presenting [1]. - Both conferences will include formats such as company presentations, fireside chats, and one-on-one investor meetings, allowing for direct engagement with potential investors [1]. Group 2: Company Overview - Rani Therapeutics is a clinical-stage biotherapeutics company focused on the development of orally administered biologics and drugs, aiming to replace traditional subcutaneous injections and intravenous infusions [2]. - The company has developed the RaniPill® capsule, a proprietary and patented platform technology that has undergone several preclinical and clinical studies to assess its safety, tolerability, and bioavailability [2].

Financial Performance - The company reported a net loss of $13.361 million for the three months ended June 30, 2024, a decrease of 28.4% compared to a net loss of $18.664 million for the same period in 2023[54]. - The company reported a net loss attributable to Rani Therapeutics Holdings, Inc. of $6.805 million for the three months ended June 30, 2024, down 26.9% from $9.303 million in the same period in 2023[54]. - The company reported a net loss of $28.1 million for the six months ended June 30, 2024, with an accumulated deficit of $87.2 million[58]. - The company reported a net loss of $28.1 million for the six months ended June 30, 2024, compared to a net loss of $35.5 million for the same period in 2023, indicating a reduction in losses[62][64]. Cash and Securities - As of June 30, 2024, the company's cash, cash equivalents, and marketable securities totaled $30.9 million[53]. - Cash, cash equivalents, and marketable securities totaled $30.9 million as of June 30, 2024, down from $48.5 million as of December 31, 2023[61]. - Total cash, cash equivalents, and marketable securities decreased to $30.9 million as of June 30, 2024, down from $48.5 million at the end of 2023[62]. - The company had a net decrease in cash, cash equivalents, and restricted cash equivalents of $1.35 million for the six months ended June 30, 2024, compared to a decrease of $19.5 million in the prior year[63]. Expenses - Research and development expenses decreased by 44.8% to $6.115 million for the three months ended June 30, 2024, compared to $11.086 million for the same period in 2023[54]. - The total operating expenses for the three months ended June 30, 2024, were $12.524 million, down 31.5% from $18.294 million in the same period in 2023[54]. - The company reported a decrease in general and administrative expenses by 11.1% to $6.409 million for the three months ended June 30, 2024, compared to $7.208 million for the same period in 2023[54]. - Research and development expenses decreased by $7.1 million to $13.7 million for the six months ended June 30, 2024, compared to $20.8 million for the same period in 2023, primarily due to lower compensation costs and reduced third-party services[57]. - General and administrative expenses decreased by $1.2 million to $6.5 million for the six months ended June 30, 2024, compared to the same period in 2023, mainly due to lower compensation costs from workforce reduction[57]. - Stock-based compensation expense for the six months ended June 30, 2024 was $8.0 million, down from $9.6 million in the same period of 2023[62][64]. Future Outlook - The company expects to continue incurring losses and will need to raise substantial additional funds to complete the development of the RaniPill platform[53]. - The company expects to continue incurring losses and has substantial doubt regarding its ability to continue as a going concern for the next year[58]. - The company has not yet generated any revenue from sales of a commercial product and does not have any products approved for sale[51]. - The company has not generated any commercial product revenue to date and will require additional capital to fund ongoing development activities[60]. Agreements and Developments - The company entered into a definitive agreement with ProGen for the co-development of RT-114, sharing a 50/50 cost and revenue arrangement[53]. - The company plans to initiate clinical testing of the RaniPill HC in the second half of 2024[51]. Capital and Financing - In July 2024, the company raised approximately $10.0 million through a Securities Purchase Agreement with an institutional investor[59]. - The company is subject to various covenants under its Loan Agreement, and compliance was maintained as of June 30, 2024[59]. - The company has agreed to restrictions on issuing new shares for 60 days following the closing of the Offering, which may limit its ability to raise additional capital[61]. Operational Efficiency - Net cash used in operating activities for the six months ended June 30, 2024 was $18.4 million, a decrease from $24.5 million in the same period of 2023, reflecting improved operational efficiency[62][64]. - Net cash provided by investing activities for the six months ended June 30, 2024 was $16.8 million, significantly higher than $4.9 million in the prior year, primarily due to $38.6 million in proceeds from maturities of marketable securities[63][64]. Internal Controls and Compliance - The company remains classified as an "emerging growth company" under the JOBS Act, allowing it to take advantage of extended compliance periods for new accounting standards[66][67]. - The company’s disclosure controls and procedures were evaluated and deemed effective at a reasonable assurance level as of June 30, 2024[68]. - There have been no changes in internal control over financial reporting that materially affected the company's financial reporting during the three months ended June 30, 2024[69].

Company Overview - Rani Therapeutics is a clinical-stage biotherapeutics company focused on advancing technologies for the oral delivery of biologics and drugs [2] - The company has developed the RaniPill® capsule, a proprietary and patented platform technology designed to replace subcutaneous injection or intravenous infusion with oral dosing [2] - Rani Therapeutics has successfully conducted several preclinical and clinical studies to evaluate the safety, tolerability, and bioavailability of the RaniPill® capsule technology [2] Upcoming Events - Rani Therapeutics will participate in the BTIG Virtual Biotechnology Conference on August 5th-6th, 2024, featuring 1x1 investor meetings [1] - The company will also present at the Canaccord 44th Annual Growth Conference on August 13th, 2024, at 3:30 PM E.T., with a format including a company presentation and 1x1 investor meetings [3]

SAN JOSE, Calif., July 29, 2024 (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 the Company will participate in two upcoming investor conferences in August 2024. These conferences include: BTIG Virtual Biotechnology Conference Location: Virtual Date: Monday, August 5th – Tuesday, August 6th, 2024 Format: 1x1 Investor Meetings Canaccord 44th A ...