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]

[Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section clarifies that all non-historical statements are forward-looking, subject to inherent risks and uncertainties, with actual results potentially differing materially from projections - All statements in this report, except historical facts, are forward-looking, involving known and unknown risks and uncertainties beyond the company's control[13](index=13&type=chunk) - Actual results, performance, or achievements may **differ materially** from those projected in forward-looking statements[13](index=13&type=chunk)[15](index=15&type=chunk) - Key areas of forward-looking statements encompass clinical trials, product candidates, R&D costs, manufacturing, regulatory approvals, financial performance, and strategic partnerships[14](index=14&type=chunk)[18](index=18&type=chunk) PART I [Item 1. Business](index=7&type=section&id=Item%201.%20Business) Rani Therapeutics, a clinical-stage biotherapeutics company, focuses on oral delivery of biologics via its RaniPill capsule technology, with three completed Phase 1 trials and ongoing pipeline development and collaborations - Rani Therapeutics is a clinical-stage biotherapeutics company advancing technologies for oral administration of biologics and drugs using its proprietary RaniPill capsule technology[22](index=22&type=chunk)[599](index=599&type=chunk) - The RaniPill platform includes two configurations: RaniPill GO, delivering up to **3 mg** drug in microtablet form with three completed Phase 1 trials, and RaniPill HC, for up to **200µL** liquid drug, with clinical testing planned mid-2025[23](index=23&type=chunk)[110](index=110&type=chunk)[600](index=600&type=chunk) - Completed Phase 1 clinical trials for RT-111 (ustekinumab biosimilar), RT-102 (parathyroid hormone), and RT-101 (octreotide) demonstrated **high bioavailability** and **good tolerability** with no serious adverse events[25](index=25&type=chunk)[26](index=26&type=chunk)[63](index=63&type=chunk)[80](index=80&type=chunk) RT-114 Preclinical Pharmacokinetic Data (Oral vs. Subcutaneous PG-102) | Route | Cmax (µg/mL)/kg | Tmax (days) | AUC (µg/mL*day)/kg | | :--- | :--- | :--- | :--- | | RT-114 | 1.51 ± 0.19 | 0.7 ± 0.1 | 5.48 ± 0.33 | | SC | 1.06 ± 0.13 | 1.3 ± 0.3 | 4.92 ± 0.52 | RT-116 (Semaglutide) Preclinical Pharmacokinetic Data (Oral vs. Subcutaneous) | Route | Cmax (ng/mL) | Tmax (days) | Tlast (days) | AUClast (ng/mL*day) | | :--- | :--- | :--- | :--- | :--- | | Oral (RT-116) | 941 ± 90 | 1.3 ± 0.3 | 17 ± 2 | 3630 ± 222 | | SC | 948 ± 120 | 1.3 ± 0.3 | 17 ± 1 | 3390 ± 402 | - In June 2024, a Collaboration Agreement was signed with ProGen Co., Ltd. for worldwide development and commercialization of RT-114, with **equal sharing of development costs and operating profits/losses**[30](index=30&type=chunk)[31](index=31&type=chunk)[152](index=152&type=chunk)[153](index=153&type=chunk)[607](index=607&type=chunk)[608](index=608&type=chunk)[761](index=761&type=chunk)[762](index=762&type=chunk) - In October and July 2024, securities purchase agreements raised aggregate net proceeds of **$9.4 million** and **$8.9 million**, respectively, from Class A common stock and warrants[32](index=32&type=chunk)[33](index=33&type=chunk)[604](index=604&type=chunk)[605](index=605&type=chunk) - The CEO's annual salary was reduced from **$520,000 to $100,000**, effective November 1, 2023, and extended through December 31, 2025, or until a **$50 million** financing threshold is met[44](index=44&type=chunk)[629](index=629&type=chunk) - The RaniPill capsule offers **high bioavailability**, a protective pH-sensitive coating, drug protection from GI fluids, delivery in both fed and fasted states, a self-inflating balloon for reliable delivery, and a drug-agnostic design[122](index=122&type=chunk)[124](index=124&type=chunk) - Product candidates are classified as combination products, with CDER expected to be the lead center for most, and a **505(b)(2) pathway** deemed suitable for RT-102 development in the U.S.[144](index=144&type=chunk)[145](index=145&type=chunk)[147](index=147&type=chunk)[149](index=149&type=chunk) - The company maintains an extensive global patent portfolio covering device aspects, specific biologics, and delivery methods, with patent terms extending into the **2030s and 2040s**[177](index=177&type=chunk)[178](index=178&type=chunk)[179](index=179&type=chunk)[180](index=180&type=chunk)[181](index=181&type=chunk)[182](index=182&type=chunk) [Item 1A. Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including going concern doubts, funding needs, uncertain clinical development, intense competition, and intellectual property challenges, which could adversely impact its business and financial condition - There is substantial doubt regarding the company's ability to continue as a going concern, necessitating additional funding that may not be available on acceptable terms[17](index=17&type=chunk)[241](index=241&type=chunk)[244](index=244&type=chunk)[641](index=641&type=chunk) - The company has incurred significant operating losses since inception (net loss of **$56.6 million** in 2024) and expects to continue incurring losses, with no commercial product revenue to date[19](index=19&type=chunk)[250](index=250&type=chunk)[251](index=251&type=chunk)[254](index=254&type=chunk)[641](index=641&type=chunk) - Clinical development is a lengthy, expensive, and uncertain process, with results from earlier studies not always predictive of future trial outcomes, and novel technologies like the RaniPill capsule have limited FDA experience, making regulatory approval unpredictable[19](index=19&type=chunk)[265](index=265&type=chunk)[268](index=268&type=chunk)[274](index=274&type=chunk)[312](index=312&type=chunk) - The company faces significant competition from major pharmaceutical and biotherapeutics companies, including manufacturers of existing injectables, other oral biologics, and device-based technologies[19](index=19&type=chunk)[171](index=171&type=chunk)[172](index=172&type=chunk)[173](index=173&type=chunk)[334](index=334&type=chunk)[339](index=339&type=chunk) - Dependence on third-party suppliers for key materials and APIs, and Contract Research Organizations (CROs) for clinical trials, poses risks if these parties fail to meet contractual duties or regulatory requirements[19](index=19&type=chunk)[353](index=353&type=chunk)[359](index=359&type=chunk)[360](index=360&type=chunk) - Commercial success relies on building and maintaining a strong intellectual property portfolio, but risks include insufficient patent coverage, challenges to patent validity, and potential infringement by competitors[20](index=20&type=chunk)[177](index=177&type=chunk)[454](index=454&type=chunk)[457](index=457&type=chunk)[459](index=459&type=chunk)[496](index=496&type=chunk) - The company's holding company structure depends on distributions from Rani LLC, and its multi-class common stock structure concentrates voting control, limiting other stockholders' influence[20](index=20&type=chunk)[511](index=511&type=chunk)[531](index=531&type=chunk) [Item 1B. Unresolved Staff Comments](index=156&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) This section states that the company has no unresolved comments from the SEC staff regarding its financial reports - There are no unresolved staff comments[578](index=578&type=chunk) [Item 1C. Cybersecurity](index=157&type=section&id=Item%201C.%20Cybersecurity) This section details the company's cybersecurity risk management and strategy, including processes for identifying, assessing, and managing threats to its information systems and data - The company implements and maintains information security processes to identify, assess, and manage material risks from cybersecurity threats to its critical computer networks, hosted services, and data[579](index=579&type=chunk)[580](index=580&type=chunk) - Mitigation measures include incident detection and response, disaster recovery, encryption, network security, access controls, monitoring, physical security, employee training, and cybersecurity insurance[581](index=581&type=chunk) - The board of directors oversees cybersecurity risk management, with the CFO leading the information security team and integrating cybersecurity risk into the overall risk management strategy[586](index=586&type=chunk)[587](index=587&type=chunk)[588](index=588&type=chunk) - Third-party service providers are utilized for threat intelligence and various business functions, with a vendor management program in place to manage associated cybersecurity risks[583](index=583&type=chunk)[584](index=584&type=chunk) [Item 2. Properties](index=158&type=section&id=Item%202.%20Properties) This section describes the company's corporate headquarters in San Jose, California, and its leased facilities, detailing square footage and lease terms for various spaces - Corporate headquarters are located in San Jose, California[589](index=589&type=chunk) - Leases approximately **57,000 square feet** of space, including **33,000 sq ft** in Fremont, California (63-month term from Feb 2024) and **24,000 sq ft** in San Jose, California (annual renewal, leased from related party ICL)[589](index=589&type=chunk)[630](index=630&type=chunk)[631](index=631&type=chunk)[775](index=775&type=chunk) [Item 3. Legal Proceedings](index=158&type=section&id=Item%203.%20Legal%20Proceedings) This section states that the company is not currently involved in any litigation or legal proceedings that management believes would have a material adverse effect on its business - The company is not currently a party to any litigation or legal proceedings that are likely to have a material adverse effect on its business[590](index=590&type=chunk)[793](index=793&type=chunk) [Item 4. Mine Safety Disclosures](index=158&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section states that the disclosure requirements for mine safety are not applicable to the company - This item is not applicable[591](index=591&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=159&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This section provides information on the trading market for the company's Class A common stock on Nasdaq, its dividend policy, and the number of stockholders, noting no anticipated cash dividends - The company's Class A common stock is traded on the Nasdaq Stock Market LLC under the symbol "RANI"[3](index=3&type=chunk)[593](index=593&type=chunk) - The company has never declared or paid cash dividends on its common stock and does not anticipate paying cash dividends in the foreseeable future, intending to retain all future earnings for business operations and expansion[548](index=548&type=chunk)[593](index=593&type=chunk) - As of March 26, 2025, there were **122 holders of record** of Class A common stock and **16 holders of record** of Class B common stock[4](index=4&type=chunk)[594](index=594&type=chunk) [Item 6. [Reserved]](index=159&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and contains no information - This item is reserved[596](index=596&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=160&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes Rani Therapeutics' financial performance, liquidity, and capital resources for 2024, highlighting a **$56.6 million** net loss, negative operating cash flows, and substantial doubt about its going concern ability, despite **$18.3 million** in equity financing and strategic operational changes - The company incurred a net loss of **$56.6 million** for the year ended December 31, 2024, and had negative cash flows from operations of **$35.5 million**, leading to substantial doubt about its ability to continue as a going concern[641](index=641&type=chunk)[653](index=653&type=chunk)[654](index=654&type=chunk)[689](index=689&type=chunk)[700](index=700&type=chunk) Cash, Cash Equivalents, and Marketable Securities (in thousands) | Metric | Dec 31, 2024 | Dec 31, 2023 | | :--------------------------------------- | :----------- | :----------- | | Cash and cash equivalents | $3,762 | $5,864 | | Marketable securities | $23,877 | $42,675 | | Total | $27,639 | $48,539 | - In 2024, the company raised **$9.4 million** net proceeds from the October Offering and **$8.9 million** net proceeds from the July Offering, totaling **$18.3 million** in equity financing[604](index=604&type=chunk)[605](index=605&type=chunk)[642](index=642&type=chunk)[643](index=643&type=chunk) - The company entered into a Collaboration Agreement with ProGen Co., Ltd. in June 2024 for the worldwide development and commercialization of RT-114, a GLP-1/GLP-2 dual agonist, with **equal sharing of development costs and operating profits/losses**[607](index=607&type=chunk)[608](index=608&type=chunk)[761](index=761&type=chunk)[762](index=762&type=chunk) - Preclinical data for RT-114 (GLP-1/GLP-2 dual agonist) demonstrated **111% relative bioavailability** compared to subcutaneous administration, with comparable pharmacokinetic profiles and weight loss[609](index=609&type=chunk)[622](index=622&type=chunk) - Preclinical data for RT-116 (semaglutide via RaniPill HC) showed **107% relative bioavailability** compared to subcutaneous administration, with comparable pharmacokinetics and weight loss[613](index=613&type=chunk)[625](index=625&type=chunk) - A workforce reduction was substantially completed by the end of the second quarter of 2024 as part of a strategic prioritization plan[628](index=628&type=chunk) - The CEO's annual salary was reduced from **$520,000 to $100,000**, effective November 1, 2023, and extended through December 31, 2025[629](index=629&type=chunk) Consolidated Results of Operations (Year Ended December 31, in thousands) | Item | 2024 | 2023 | Change (%) | | :--------------------------------- | :----- | :----- | :--------- | | Contract revenue | $1,028 | $0 | * | | Research and development | $26,682 | $39,624 | (32.7)% | | General and administrative | $23,946 | $26,475 | (9.6)% | | Impairment loss | $3,714 | $0 | * | | Total operating expenses | $54,342 | $66,099 | (17.8)% | | Loss from operations | $(53,314) | $(66,099) | (19.3)% | | Interest income and other, net | $1,763 | $3,301 | (46.6)% | | Interest expense and other, net | $(5,033) | $(5,085) | (1.0)% | | Net loss | $(56,584) | $(67,883) | (16.6)% | | Net loss attributable to Rani Holdings, Inc. | $(30,018) | $(33,970) | (11.6)% | Contractual Obligations and Commitments (as of December 31, 2024, in thousands) | Obligation | Total | Short-term | Long-term | | :-------------------- | :------ | :--------- | :-------- | | Operating leases | $5,096 | $1,459 | $3,637 | | Debt obligations | $26,263 | $15,000 | $11,263 | | Total | $31,359 | $16,459 | $14,900 | [Item 7A. Quantitative and Qualitative Disclosures about Market Risk](index=175&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, Rani Therapeutics Holdings, Inc. is not required to provide quantitative and qualitative disclosures about market risk - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[669](index=669&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=176&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the complete audited consolidated financial statements for Rani Therapeutics Holdings, Inc. for 2024 and 2023, including balance sheets, statements of operations, comprehensive loss, changes in stockholders' equity, cash flows, and detailed notes - Independent registered public accounting firms issued unqualified opinions on the financial statements but included explanatory paragraphs regarding substantial doubt about the company's ability to continue as a going concern[673](index=673&type=chunk)[674](index=674&type=chunk)[680](index=680&type=chunk)[681](index=681&type=chunk) Consolidated Balance Sheets (as of December 31, in thousands) | Asset/Liability/Equity | 2024 | 2023 | | :------------------------------------------------ | :----- | :----- | | Cash and cash equivalents | $3,762 | $5,864 | | Marketable securities | $23,877 | $42,675 | | Total current assets | $29,744 | $50,847 | | Property and equipment, net | $1,548 | $6,105 | | Total assets | $36,634 | $57,916 | | Total current liabilities | $19,891 | $7,989 | | Long-term debt, less current portion | $9,613 | $24,484 | | Total liabilities | $33,141 | $32,473 | | Total stockholders' equity | $3,493 | $25,443 | Consolidated Statements of Operations (Year Ended December 31, in thousands) | Item | 2024 | 2023 | | :------------------------------------------------ | :----- | :----- | | Contract revenue | $1,028 | $0 | | Research and development expenses | $26,682 | $39,624 | | General and administrative expenses | $23,946 | $26,475 | | Impairment loss | $3,714 | $0 | | Net loss | $(56,584) | $(67,883) | | Net loss attributable to Rani Holdings, Inc. | $(30,018) | $(33,970) | | Net loss per Class A common share, basic and diluted | $(1.05) | $(1.33) | Consolidated Statements of Cash Flows (Year Ended December 31, in thousands) | Activity | 2024 | 2023 | | :-------------------------------- | :------- | :------- | | Net cash used in operating activities | $(35,496) | $(51,236) | | Net cash provided by investing activities | $19,809 | $29,860 | | Net cash provided by financing activities | $13,585 | $233 | | Net decrease in cash, cash equivalents and restricted cash equivalents | $(2,102) | $(21,143) | - An impairment loss of **$3.7 million** was recognized in 2024 related to construction-in-progress property and equipment, as its carrying amount exceeded its fair value[639](index=639&type=chunk)[742](index=742&type=chunk) Tax Attribute Carryforwards (as of December 31, 2024, in thousands) | Attribute | Amount | Expiration Years | | :------------------------------------ | :----- | :--------------- | | Net operating losses, federal (post 2017) | $61,725 | Indefinite | | Net operating loss, state (definite) | $91,958 | 2041 - 2044 | | Research and development tax credits, federal | $2,608 | 2041 - 2044 | | Research and development tax credits, state | $1,806 | Indefinite | [Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=213&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) This section confirms that there have been no changes in or disagreements with the company's independent registered public accounting firm on accounting or financial disclosure matters - There have been no changes in or disagreements with accountants on accounting and financial disclosure[808](index=808&type=chunk) [Item 9A. Controls and Procedures](index=213&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures and internal control over financial reporting were effective at a reasonable assurance level as of December 31, 2024, acknowledging inherent limitations of control systems - Disclosure controls and procedures were evaluated and deemed effective at a reasonable assurance level as of December 31, 2024[809](index=809&type=chunk) - Management concluded that internal control over financial reporting was effective as of December 31, 2024[810](index=810&type=chunk) - The report highlights that internal control systems, due to inherent limitations, can only provide reasonable assurance and may not prevent or detect all misstatements[811](index=811&type=chunk)[814](index=814&type=chunk) [Item 9B. Other Information](index=215&type=section&id=Item%209B.%20Other%20Information) This section states that there is no other information to report under this item - No other information is reported under this item[815](index=815&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=215&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This section states that the disclosure requirements regarding foreign jurisdictions that prevent inspections are not applicable to the company - This item is not applicable[816](index=816&type=chunk) PART III [Item 10. Directors, Executive Officers and Corporate Governance](index=216&type=section&id=Item%2010.%20Directors,%20Executive%20Officers%20and%20Corporate%20Governance) This section incorporates information regarding the company's directors, executive officers, and corporate governance from its definitive Proxy Statement for the 2025 Annual Meeting of Stockholders, including the adoption of a code of business conduct and ethics - Information required by this item is incorporated by reference from the definitive Proxy Statement for the 2025 Annual Meeting of Stockholders[818](index=818&type=chunk) - The company has adopted a written code of business conduct and ethics applicable to its directors, officers, and employees[819](index=819&type=chunk) [Item 11. Executive Compensation](index=216&type=section&id=Item%2011.%20Executive%20Compensation) This section incorporates information regarding executive compensation from the company's definitive Proxy Statement for the 2025 Annual Meeting of Stockholders - Information required by this item is incorporated by reference from the definitive Proxy Statement[820](index=820&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=216&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) This section incorporates information regarding security ownership of certain beneficial owners and management, and related stockholder matters, from the company's definitive Proxy Statement for the 2025 Annual Meeting of Stockholders - Information required by this item is incorporated by reference from the definitive Proxy Statement[821](index=821&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=216&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) This section incorporates information regarding certain relationships and related transactions, and director independence, from the company's definitive Proxy Statement for the 2025 Annual Meeting of Stockholders - Information required by this item is incorporated by reference from the definitive Proxy Statement[822](index=822&type=chunk) [Item 14. Principal Accountant Fees and Services](index=216&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) This section incorporates information regarding principal accountant fees and services from the company's definitive Proxy Statement for the 2025 Annual Meeting of Stockholders - Information required by this item is incorporated by reference from the definitive Proxy Statement[823](index=823&type=chunk) [Item 15. Exhibit and Financial Statement Schedules](index=217&type=section&id=Item%2015.%20Exhibit%20and%20Financial%20Statement%20Schedules) This section lists all exhibits and financial statement schedules filed or furnished as part of the 10-K report - This section lists all exhibits and financial statement schedules filed or furnished as part of the 10-K report[824](index=824&type=chunk)[826](index=826&type=chunk) - Exhibits include financial statements, organizational documents (Certificate of Incorporation, Bylaws), warrant forms, various agreements (e.g., Tax Receivable Agreement, License and Supply Agreements), and certifications[826](index=826&type=chunk)[827](index=827&type=chunk)[832](index=832&type=chunk) - Certifications of the Principal Executive Officer and Principal Financial Officer are included pursuant to the Sarbanes-Oxley Act of 2002[829](index=829&type=chunk)[832](index=832&type=chunk) [Item 16. Form 10-K Summary](index=221&type=section&id=Item%2016.%20Form%2010-K%20Summary) This section states that no Form 10-K Summary is provided - No Form 10-K Summary is provided[831](index=831&type=chunk) [Signatures](index=222&type=section&id=Signatures) This section confirms the Annual Report on Form 10-K is duly signed by the registrant's authorized officers and directors - The Annual Report on Form 10-K is duly signed by the registrant's authorized officers and directors[834](index=834&type=chunk)[837](index=837&type=chunk) - Signatories include the Chief Executive Officer (Talat Imran), Chief Financial Officer (Svai Sanford), Chairman of the Board (Mir Imran), and other directors[836](index=836&type=chunk)[838](index=838&type=chunk) - The report was signed on March 31, 2025[838](index=838&type=chunk)

Financial Performance - Rani Therapeutics reported a net loss of $15.7 million for Q4 2024, compared to a net loss of $14.1 million in Q4 2023, and a full-year net loss of $56.6 million versus $67.9 million in 2023[9]. - Net loss for the three months ended December 31, 2024, was $15,721 million, compared to a net loss of $14,055 million in the same period of 2023, reflecting a 12% increase in losses[17]. - Net loss attributable to Rani Therapeutics Holdings, Inc. was $8,946 million for Q4 2024, compared to $7,099 million in Q4 2023, indicating a 26% increase in losses[17]. - Net loss per Class A common share attributable to Rani Therapeutics Holdings, Inc. was $0.27 for Q4 2024, unchanged from Q4 2023[17]. Revenue and Expenses - The company reported contract revenue of $1.0 million for both Q4 and full-year 2024, attributed to evaluation services, with no contract revenue in the same periods of 2023[8]. - Total operating expenses increased to $15,986 million in Q4 2024 from $13,435 million in Q4 2023, representing a 19% increase[17]. - General and administrative expenses for Q4 2024 were $5.5 million, down from $5.8 million in Q4 2023, with full-year expenses at $23.9 million compared to $26.5 million in 2023[8]. - Total operating expenses for the year ended December 31, 2024, were $54,342 million, down from $66,099 million in 2023, a decrease of about 18%[17]. - Interest income decreased to $361 million in Q4 2024 from $676 million in Q4 2023, a decline of approximately 47%[17]. - Impairment loss recorded in Q4 2024 was $3,714 million, with no impairment loss reported in Q4 2023[17]. Cash and Funding - Cash, cash equivalents, and marketable securities as of December 31, 2024, totaled $27.6 million, down from $48.5 million at the end of 2023, with expectations to fund operations into Q3 2025 without additional funding[8]. - The company completed two equity offerings in 2024, generating approximately $20.0 million in gross proceeds[4]. Research and Development - Research and development expenses for Q4 2024 were $6.8 million, a decrease from $7.6 million in Q4 2023, while full-year R&D expenses were $26.7 million compared to $39.6 million in 2023[8]. - Research and development expenses decreased to $6,810 million in Q4 2024 from $7,606 million in Q4 2023, a reduction of approximately 10%[17]. - The Phase 1 clinical trial for RT-114 is expected to initiate in mid-2025, focusing on obesity treatment[6]. - Rani Therapeutics announced preclinical data showing RT-114, a GLP-1/GLP-2 dual agonist, achieved a relative bioavailability of 111% compared to subcutaneous administration[8]. - Rani Therapeutics highlighted successful oral delivery of semaglutide via the RaniPill® capsule, demonstrating comparable bioavailability and weight loss to subcutaneous administration[3]. Partnerships and Market Position - The company has partnered with ProGen for the co-development and commercialization of RT-114, enhancing its market position in obesity treatments[4].

- Phase 1 study for RT-114 for the treatment of obesity, expected to initiate in mid-2025 - - Conference call today at 4:30 p.m. ET / 1:30 p.m. PT - SAN JOSE, Calif., March 31, 2025 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. ("Rani Therapeutics" or "Rani") (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today reported financial results for the quarter and full year ended December 31, 2024 and provided a corporate update. "We entered 202 ...

Core Insights - Rani Therapeutics has announced promising results for RT-114, an orally administered GLP-1/GLP-2 dual agonist, demonstrating bioequivalence to subcutaneously delivered PG-102 with a relative bioavailability of 111% [1][2][8] - The preclinical study showed comparable weight loss outcomes between RT-114 and SC PG-102, with RT-114 exhibiting less variability in weight loss results [1][4] - The company plans to initiate a Phase 1 clinical trial for RT-114 in mid-2025, furthering its commitment to developing oral therapies for obesity [1][9] Company Overview - Rani Therapeutics is focused on advancing oral delivery technologies for biologics and drugs, specifically through its proprietary RaniPill® capsule [10] - The company has successfully conducted multiple preclinical and clinical studies to evaluate the safety, tolerability, and bioavailability of its oral delivery system [10] - RT-114 is part of a collaboration agreement with ProGen, aimed at developing and commercializing the drug for weight management [11] Clinical Data Highlights - In a preclinical study, RT-114 achieved a peak weight loss of 6.7% with a delivery success rate of 90% in canines, indicating strong pharmacokinetic and pharmacodynamic relationships [8] - The Phase 1 clinical trial of SC PG-102 showed an average weight loss of 4.8% and up to 8.7% after five weeks of dosing, demonstrating the drug's effectiveness in obese patients [3][4] - The pharmacokinetic data indicated that RT-114 had a Cmax of 1.51 µg/mL/kg and Tmax of 0.7 days, compared to SC PG-102's Cmax of 1.06 µg/mL/kg and Tmax of 1.3 days [7][8] Market Potential - RT-114 is positioned to fill a critical gap in the obesity treatment landscape by providing an effective oral alternative to existing injectable GLP-1 receptor agonists [2][4] - The convenience of an oral dosing regimen is expected to enhance patient compliance and address challenges associated with current GLP-1 treatment options [2][4]

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

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]