Rani Therapeutics (US:RANI)2025-08-07 20:15PART I. FINANCIAL INFORMATION This section presents the unaudited financial statements, management's analysis, market risk disclosures, and controls for the period Financial Statements (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 million32 - 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 date3233 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 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 funding130173 - 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 million114 - 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 agreement111112 - 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 HC116118 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 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 risk162 Controls and Procedures 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 level163 - 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 controls164 PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, and other disclosures Legal Proceedings 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 business168 Risk Factors 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 bankruptcy170172173 - 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 capital181182183 - 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 Korea186187188 Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities during the period - None reported192 Defaults Upon Senior Securities There were no defaults upon senior securities during the period - None reported193 Mine Safety Disclosures This item is not applicable to the company - Not applicable194 Other Information 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 salaries195 Exhibits This section lists the exhibits filed with the report, including certifications by the Principal Executive and Financial Officers