[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) The financial information section details the company's financial statements, management's analysis, and related disclosures [Item 1. Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) Cash increased to **$12.3 million** by June 30, 2025, with initial RenovoCath revenues, but net losses persisted [Condensed Balance Sheets](index=7&type=section&id=Condensed%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%2C%20and%20December%2031%2C%202024) This section presents the company's financial position at specific points in time Condensed Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $12,314 | $7,154 | | Total current assets | $13,395 | $7,828 | | Total assets | $13,643 | $8,118 | | Total current liabilities | $1,556 | $1,909 | | Total liabilities | $3,002 | $3,640 | | Total stockholders' equity | $10,641 | $4,478 | [Condensed Statements of Operations](index=8&type=section&id=Condensed%20Statements%20of%20Operations%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%2C%20and%202024) This section outlines the company's revenues, expenses, and net loss over specific periods Condensed Statements of Operations Highlights (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $422 | $- | $619 | $- | | Gross profit | $270 | $- | $373 | $- | | Loss from operations | $(2,678) | $(3,034) | $(5,788) | $(5,510) | | Net loss | $(2,895) | $(2,389) | $(5,315) | $(3,465) | | Net loss per share, basic and diluted | $(0.08) | $(0.10) | $(0.16) | $(0.18) | [Condensed Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit)](index=9&type=section&id=Condensed%20Statements%20of%20Convertible%20Preferred%20Stock%20and%20Stockholders%27%20Equity%20%28Deficit%29%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%2C%20and%202024) This section details changes in the company's equity structure and accumulated deficit [Condensed Statements of Cash Flows](index=11&type=section&id=Condensed%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202025%2C%20and%202024) This section summarizes the cash inflows and outflows from operating, investing, and financing activities Condensed Statements of Cash Flows Highlights (in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(5,683) | $(4,501) | | Net cash used in investing activities | $(2) | $- | | Net cash provided by financing activities | $10,845 | $15,070 | | Net increase in cash and cash equivalents | $5,160 | $10,569 | | Cash and cash equivalents, end of period | $12,314 | $11,742 | [Notes to the Unaudited Condensed Interim Financial Statements](index=12&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Interim%20Financial%20Statements) Notes detail the company's business, history of losses, capital needs, **$12.3 million** cash, and accounting policies [1. Business and Principal Activities](index=12&type=section&id=1.%20Business%20and%20Principal%20Activities) This note describes the company's core business, products, and strategic focus - RenovoRx, Inc. is a commercial and clinical stage life sciences company offering **RenovoCath®**, an **FDA-cleared** local drug delivery device, and developing **IAG** (intra-arterial delivery of gemcitabine via RenovoCath) in a **Phase III clinical study** for locally advanced pancreatic cancer[28](index=28&type=chunk)[29](index=29&type=chunk)[30](index=30&type=chunk) - The company has raised an aggregate of **$71.4 million** since inception, with net proceeds of **$64.3 million**; as of June 30, 2025, cash and cash equivalents were **$12.3 million**; the company had an accumulated deficit of approximately **$55.5 million** and expects to continue incurring significant losses, necessitating additional capital[32](index=32&type=chunk)[33](index=33&type=chunk)[34](index=34&type=chunk) Recent Equity Financing Net Proceeds (in millions) | Offering | Net Proceeds (in millions) | | :--- | :--- | | April 3, 2023 RDO | $4.3 | | January 26, 2024 Private Placement | $5.4 (gross $6.1 less $0.7 expenses) | | April 11, 2024 Private Placement | $9.6 | | February 10, 2025 Public Offering | $10.8 | - Management believes current cash and cash equivalents will be **sufficient to fund operations through at least the next 12 months** from the issuance of this Report[41](index=41&type=chunk) [2. Summary of Significant Accounting Policies](index=14&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements [3. Fair Value Measurements](index=16&type=section&id=3.%20Fair%20Value%20Measurements) This note details the valuation techniques and inputs used for assets and liabilities measured at fair value [4. Property and Equipment, Net](index=17&type=section&id=4.%20Property%20and%20Equipment%2C%20Net) This note provides information on the company's tangible assets and their depreciation [5. Accrued Expenses](index=17&type=section&id=5.%20Accrued%20Expenses) This note details the company's short-term liabilities for services received but not yet paid [6. Leases, Commitments and Contingencies](index=18&type=section&id=6.%20Leases%2C%20Commitments%20and%20Contingencies) This note describes the company's lease obligations, contractual commitments, and potential liabilities [7. Equity Incentive Plan – Stock-Based Compensation Expense and Warrants](index=19&type=section&id=7.%20Equity%20Incentive%20Plan%20%E2%80%93%20Stock-Based%20Compensation%20Expense%20and%20Warrants) This note explains the accounting for stock options, restricted stock, and warrants issued to employees and others Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $106 | $81 | $243 | $207 | | General and administrative | $239 | $163 | $390 | $460 | | **Total** | **$345** | **$244** | **$633** | **$667** | [8. Income Taxes](index=21&type=section&id=8.%20Income%20Taxes) This note provides details on the company's income tax provisions, deferred taxes, and tax loss carryforwards [9. Net Loss Per Share](index=22&type=section&id=9.%20Net%20Loss%20Per%20Share) This note explains the calculation of basic and diluted net loss per share [10. Segment Information](index=22&type=section&id=10.%20Segment%20Information) This note provides financial data for the company's operating segments, if applicable [11. Related Party Transactions](index=23&type=section&id=11.%20Related%20Party%20Transactions) This note discloses transactions with parties that have a special relationship with the company - Consulting fees paid to co-founder Dr. Ramtin Agah were **$84,000** for the three months ended June 30, 2025 (vs. **$63,000** in 2024) and **$168,000** for the six months ended June 30, 2025 (vs. **$152,000** in 2024); a discretionary bonus of **$121,000** was paid to Dr. Agah in February 2025[85](index=85&type=chunk) [12. Subsequent Events](index=23&type=section&id=12.%20Subsequent%20Events) This note describes significant events that occurred after the balance sheet date but before the financial statements were issued - The **One Big Beautiful Bill Act (OBBBA)** was signed into law on **July 4, 2025**, amending U.S. tax law; the Company is currently evaluating its impact on consolidated financial statements[86](index=86&type=chunk) [Item 2: Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202%3A%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, RenovoCath commercialization, IAG clinical trial progress, and capital needs - RenovoRx is a commercial and clinical stage life sciences company focused on **RenovoCath**, an **FDA-cleared** local drug delivery device, and its lead product candidate **IAG** for locally advanced pancreatic cancer[91](index=91&type=chunk)[92](index=92&type=chunk)[93](index=93&type=chunk) [Overview](index=24&type=section&id=Overview) This section provides a high-level summary of the company's business and financial performance [Commercialization of RenovoCath](index=24&type=section&id=Commercialization%20of%20RenovoCath) This section discusses the progress and results of the company's efforts to market and sell RenovoCath - Commercialization of RenovoCath, launched in **Q4 2024**, generated approximately **$420,000** in revenue in **Q2 2025**, a significant increase from **$197,000** in **Q1 2025**, driven by new and repeat customer orders from diverse medical institutions[95](index=95&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk) [Our Ongoing Pivotal Phase III Trial for IAG](index=26&type=section&id=Our%20Ongoing%20Pivotal%20Phase%20III%20Trial%20for%20IAG) This section details the status and key developments of the Phase III clinical trial for IAG - The ongoing **Phase III TIGeR-PaC clinical trial** for **IAG** in locally advanced pancreatic cancer received a recommendation from the independent **Data Monitoring Committee (DMC)** to continue the trial after its second interim analysis; as of **August 12, 2025**, **95 patients** have been randomized and **61 events** have occurred, with enrollment targeted for completion this year or early next year[104](index=104&type=chunk)[106](index=106&type=chunk)[107](index=107&type=chunk) [Launch of the Multi-Center Post-Marketing Registry Study to Evaluate Chemotherapy Delivered by RenovoCath Device to Solid Tumors](index=27&type=section&id=Launch%20of%20the%20Multi-Center%20Post-Marketing%20Registry%20Study%20to%20Evaluate%20Chemotherapy%20Delivered%20by%20RenovoCath%20Device%20to%20Solid%20Tumors) This section describes the initiation and objectives of the new post-marketing registry study for RenovoCath - In **July 2025**, the company launched the **PanTheR Post-Marketing Registry Study** to evaluate the long-term safety and survival outcomes of **RenovoCath** for targeted chemotherapy delivery in various solid tumors, aiming to capture real-world data and inform future clinical trial designs[109](index=109&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk) [Cash Resources, History of Losses and Planned Activities](index=27&type=section&id=Cash%20Resources%2C%20History%20of%20Losses%20and%20Planned%20Activities) This section addresses the company's liquidity, accumulated losses, and future operational plans - The company has an accumulated deficit of **$55.5 million** as of **June 30, 2025**, and expects to continue incurring significant operating losses, necessitating additional capital through equity/debt financings or collaborations to fund ongoing commercialization, R&D, and clinical trials[112](index=112&type=chunk)[114](index=114&type=chunk)[117](index=117&type=chunk) [Components of Our Results of Operations](index=28&type=section&id=Components%20of%20Our%20Results%20of%20Operations) This section details revenue recognition, cost of revenue, R&D, SG&A, and other income/expense components [Revenue](index=28&type=section&id=Revenue) This subsection explains how the company recognizes revenue from its product sales - Revenue from **RenovoCath sales** is recognized at the point of customer control, typically upon delivery; variable consideration is limited to return rights for product damage or defects[118](index=118&type=chunk) [Cost of Revenue](index=29&type=section&id=Cost%20of%20Revenue) This subsection details the direct costs associated with generating product revenue - Cost of revenue consists of third-party manufacturing, shipping, and handling costs for **RenovoCath devices** not associated with the **TIGeR-PaC study**; previously, all manufacturing costs were expensed as research and development[119](index=119&type=chunk) [Research and Development](index=29&type=section&id=Research%20and%20Development) This subsection outlines the expenses incurred for product development and clinical trials - Research and development expenses include costs for clinical trial sites, contract research organizations, consultants, clinical trial materials, personnel, regulatory compliance, and non-recurring engineering for next-generation **RenovoCath**; payments from clinical trial sites for RenovoCath devices offset R&D expenses[120](index=120&type=chunk)[121](index=121&type=chunk)[128](index=128&type=chunk) [Selling, General and Administrative](index=30&type=section&id=Selling%2C%20General%20and%20Administrative) This subsection describes the costs related to sales, marketing, and corporate overhead - Selling, general and administrative expenses comprise salaries, benefits, stock-based compensation for executive, finance, commercial, and administrative functions, professional services, consulting, conferences, travel, and allocated overhead; these expenses are expected to **increase with expanded commercialization efforts** and hiring of sales and marketing personnel[123](index=123&type=chunk) [Other Income](index=30&type=section&id=Other%20Income) This subsection covers non-operating income sources, such as interest and dividends [Change in Fair Value of Warrant Liability](index=30&type=section&id=Change%20in%20Fair%20Value%20of%20Warrant%20Liability) This subsection explains the impact of changes in the valuation of warrant liabilities on financial results - Change in fair value of warrant liability represents the gain or loss reported from the change in the fair value of the **common stock warrant liability**, primarily influenced by changes in the **company's stock price**[125](index=125&type=chunk) [Income Tax Expense](index=30&type=section&id=Income%20Tax%20Expense) This subsection details the company's tax obligations and related expenses [Results of Operations](index=31&type=section&id=Results%20of%20Operations) First RenovoCath revenues in Q4 2024, with Q2 2025 revenue at **$0.4 million**, but net losses increased [Comparison of the Three Months Ended June 30, 2025 and 2024](index=31&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) This subsection compares the company's financial performance for the three-month periods Revenue and Cost of Revenue (Three Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $422 | $- | $422 | n/a | | Cost of revenues | $152 | $- | $152 | n/a | | Gross profit | $270 | $- | $270 | n/a | Operating Expenses (Three Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $1,426 | $1,542 | $(116) | (8)% | | Selling, general and administrative | $1,522 | $1,492 | $30 | 2% | | Total operating expenses | $2,948 | $3,034 | $(86) | (3)% | | Loss from operations | $(2,678) | $(3,034) | $356 | 12% | Other Income (Expense) and Net Loss (Three Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Interest and dividend income | $133 | $138 | $(5) | (4)% | | Change in fair value of common warrant liability | $(350) | $507 | $(857) | (169)% | | Total other (expense) income, net | $(217) | $645 | $(862) | (134)% | | Net loss | $(2,895) | $(2,389) | $(506) | (21)% | [Comparison of the Six Months Ended June 30, 2025 and 2024](index=32&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This subsection compares the company's financial performance for the six-month periods Revenue and Cost of Revenue (Six Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $619 | $- | $619 | n/a | | Cost of revenues | $246 | $- | $246 | n/a | | Gross profit | $373 | $- | $373 | n/a | Operating Expenses (Six Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,068 | $2,799 | $269 | 10% | | Selling, general and administrative | $3,093 | $2,711 | $382 | 14% | | Total operating expenses | $6,161 | $5,510 | $651 | 12% | | Loss from operations | $(5,788) | $(5,510) | $(278) | (5)% | Other Income and Net Loss (Six Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Interest and dividend income | $239 | $175 | $64 | 37% | | Change in fair value of common warrant liability | $234 | $1,870 | $(1,636) | (87)% | | Total other income, net | $473 | $2,045 | $(1,572) | (77)% | | Net loss | $(5,315) | $(3,465) | $(1,850) | (53)% | [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) Historically funded by equity, with **$12.3 million** cash, the company faces ongoing losses and needs more capital - From inception through **June 30, 2025**, the company raised an aggregate of **$71.4 million**, primarily from private and public equity financings, with net proceeds of **$64.3 million**[141](index=141&type=chunk) - As of **June 30, 2025**, cash and cash equivalents totaled **$12.3 million**[141](index=141&type=chunk) - The company had an accumulated deficit of approximately **$55.5 million** and reported net losses of **$2.9 million** for the three months and **$5.3 million** for the six months ended **June 30, 2025**[141](index=141&type=chunk) - Management expects current cash and cash equivalents to be **sufficient to fund operating, investing, and financing cash flow needs for at least the next twelve months**, assuming programs advance as contemplated[141](index=141&type=chunk) - The company anticipates needing to raise **additional capital** through debt, equity, license agreements, or other arrangements to support continued commercialization of RenovoCath and development of product candidates[142](index=142&type=chunk)[147](index=147&type=chunk) Cash Flows Summary (Six Months Ended June 30, in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Operating activities | $(5,683) | $(4,501) | | Investing activities | $(2) | $- | | Financing activities | $10,845 | $15,070 | | Increase in cash and cash equivalents | $5,160 | $10,569 | [Contractual Obligations and Other Commitments](index=36&type=section&id=Contractual%20Obligations%20and%20Other%20Commitments) No material changes in contractual obligations or commitments since the 2024 Annual Report filing - **No material changes** in contractual obligations or other commitments since the 2024 Annual Report[154](index=154&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=36&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) No significant changes to critical accounting policies or estimates for the six months ended June 30, 2025 - **No significant changes** to critical accounting policies or significant judgments and estimates for the six months ended June 30, 2025, from those disclosed in the 2024 Annual Report[156](index=156&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=36&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) Company qualifies as an "emerging growth company" and "smaller reporting company," allowing reduced reporting requirements - The company is an "**emerging growth company**" as defined in the **JOBS Act**, allowing for **reduced reporting requirements** and an **extended transition period** for new accounting standards[160](index=160&type=chunk) - The company is also a "**smaller reporting company**," which provides **exemptions from certain disclosure requirements**, such as presenting only two years of audited financial statements in its Annual Report on Form 10-K and reduced executive compensation disclosures[162](index=162&type=chunk) [Recently Issued and Adopted Accounting Pronouncements](index=37&type=section&id=Recently%20Issued%20and%20Adopted%20Accounting%20Pronouncements) No new accounting pronouncements are expected to materially impact the financial statements since the 2024 Annual Report - **No new accounting pronouncements** issued or effective since the 2024 Annual Report are expected to have a **material impact** on the company's financial statements[163](index=163&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This item is not required for the company as it qualifies as a smaller reporting company under federal securities laws - The company qualifies as a **smaller reporting company**, **exempting it from the requirement** to provide quantitative and qualitative disclosures about market risk[164](index=164&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were ineffective as of June 30, 2025, due to material weaknesses in accounting policies and staffing [Evaluation of Disclosure Controls and Procedures](index=37&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section details management's assessment of the effectiveness of the company's disclosure controls - Disclosure controls and procedures were concluded as **not effective** as of **June 30, 2025**, due to previously identified **material weaknesses** in internal control over financial reporting[165](index=165&type=chunk) [Previously Identified Material Weakness](index=38&type=section&id=Previously%20Identified%20Material%20Weakness) This section describes the significant deficiencies in internal control over financial reporting identified by management - Material weaknesses include **inadequate formal accounting policies and controls** for complex transactions due to a **lack of finance and accounting staff** with appropriate GAAP technical expertise[169](index=169&type=chunk) - Additional material weaknesses involve **insufficient staffing and written policies** for accounting and financial reporting, leading to **significant control gaps** in the financial statement close process, including **lack of segregation of duties** and **proper IT general controls** related to user access[169](index=169&type=chunk) - **Remediation efforts are in progress**, including engaging **additional accounting and financial reporting personnel**, developing an **accounting policy manual**, and establishing **effective monitoring and oversight controls** for non-recurring and complex transactions[170](index=170&type=chunk) - Despite the identified material weaknesses, management believes the condensed interim financial statements are **fairly presented, in all material respects, in accordance with GAAP**[165](index=165&type=chunk) [Changes in Internal Control over Financial Reporting](index=38&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports any material changes in internal control over financial reporting [PART II. OTHER INFORMATION](index=39&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional non-financial information, including legal proceedings, risk factors, and equity security sales [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently engaged in any material legal proceedings for the periods ended June 30, 2025 - The company was **not subject to any material legal proceedings** during the three and six months ended June 30, 2025, and no material legal proceedings are subsequently outstanding or pending[174](index=174&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) Investing in RenovoRx involves high risk due to no approved products, limited commercial experience, losses, and capital needs [Risk Factors Summary](index=39&type=section&id=Risk%20Factors%20Summary) This section provides a concise overview of the primary risks associated with investing in the company - The company has **no drug/device combination products approved** for commercial sale, only **limited experience in commercializing standalone medical devices**, and **no operating history as a revenue-generating company**, making future success difficult to predict[176](index=176&type=chunk) - The company has incurred **significant net losses since inception** and expects to **continue incurring losses** until FDA approval for product candidates or sufficient RenovoCath commercial revenue is generated[176](index=176&type=chunk) - Estimates of total addressable market, potential revenues for RenovoCath, and timelines for clinical trial completion and data readout **may prove inaccurate** due to the newness of commercial efforts and inherent uncertainties in clinical trials[176](index=176&type=chunk) - The company will likely need to raise **substantial additional capital** for IAG development and commercialization, as well as for RenovoCath sales and marketing; failure to obtain timely funding could **delay or eliminate product development and commercial efforts**, potentially **impacting the company's ability to continue as a going concern**[177](index=177&type=chunk) - The **commercial viability** of product candidates is subject to current and future preclinical studies, clinical trials (notably **Phase III TIGeR-PaC**), and **regulatory approvals**; failure to successfully advance or develop product candidates would **materially harm the business**[177](index=177&type=chunk) - **Inability to effectively protect intellectual property** could prevent the company from stopping third parties from using its technologies, **impairing its competitive advantage**, or competitors may develop more effective technologies without infringement[177](index=177&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) In June 2025, RenovoRx issued **36,000** restricted common shares to Encode Ideas LLC for investor relations services - In **June 2025**, the company issued **36,000 restricted common shares** to **Encode Ideas LLC** for investor relations outreach services, vesting monthly over one year[178](index=178&type=chunk) - The issuance of these restricted common shares relied on the **private placement exemption from registration** provided by **Section 4(a)(2) of the Securities Act**[178](index=178&type=chunk) [Item 3. Defaults Upon Senior Securities](index=41&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There are no defaults upon senior securities to report - None[179](index=179&type=chunk) [Item 4. Mine Safety Disclosures](index=41&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[180](index=180&type=chunk) [Item 5. Other Information](index=41&type=section&id=Item%205.%20Other%20Information) No other information is applicable for this item - Not applicable[181](index=181&type=chunk) [Item 6. Exhibits](index=42&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed, including corporate documents, warrant forms, equity plans, and officer certifications - The exhibits include the **Sixth Amended and Restated Certificate of Incorporation** and **Amended and Restated Bylaws** of RenovoRx, Inc[184](index=184&type=chunk) - Various forms of warrants are included, such as **Private Common Stock Warrants, Underwriter's Warrants, Pre-Funded Common Stock Purchase Warrants, Series A and B Warrants, and Placement Agent Warrants**[184](index=184&type=chunk) - The **Amended and Restated 2021 Omnibus Equity Incentive Plan** and the **Supply Agreement with Medical Murray, Inc.** (**RenovoCath manufacturer**) are filed[184](index=184&type=chunk) - **Certifications of the Principal Executive Officer and Principal Financial Officer** pursuant to the **Sarbanes-Oxley Act** are furnished[184](index=184&type=chunk) [SIGNATURES](index=44&type=section&id=SIGNATURES) The report is signed by Shaun R. Bagai, CEO, and Ronald B. Kocak, VP Controller, on August 14, 2025 - The report was signed by **Shaun R. Bagai, Chief Executive Officer**, and **Ronald B. Kocak, VP Controller and Principal Accounting Officer**[188](index=188&type=chunk) - The signing date for the report was **August 14, 2025**[188](index=188&type=chunk)

Core Insights - RenovoRx has expanded its commercial footprint to thirteen cancer centers approved to purchase its RenovoCath device, a significant increase from five centers in Q1 2025 [2][3] - The company has hired Philip Stocton as Senior Director of Sales and Market Development to enhance its commercialization strategy [4][6] - There is a growing clinical demand for localized solid tumor drug-delivery options, indicating a positive market trend for RenovoRx's offerings [3][5] Company Developments - Since launching commercial efforts in December 2024, RenovoRx has established a customer base of thirteen cancer centers, with four actively using RenovoCath and placing repeat orders [2][11] - The hiring of Philip Stocton, who has over 25 years of experience in MedTech sales, is expected to drive the company's commercialization efforts [4][6] - The company is focused on building sales momentum without significant capital outlays, indicating a strategic approach to growth [6] Product Information - RenovoCath is an FDA-cleared drug-delivery device designed for targeted therapeutic delivery, aiming to minimize systemic toxicity compared to traditional chemotherapy methods [8][9] - The device is currently being evaluated in the ongoing Phase III TIGeR-PaC trial, which could lead to additional customer acquisition post-enrollment completion [3][9] - RenovoRx's TAMP therapy platform, enabled by RenovoCath, aims to improve safety and efficacy for cancer patients [8][10]

Summary of RenovoRx (RNXT) Conference Call - May 21, 2025 Company Overview - RenovoRx specializes in localized chemotherapy delivery through its patented device, RenovoCath, which utilizes a method called transarterial microperfusion (TAMP) [1][2] - The company has received orphan drug designation for its drug-device combination product in two indications, with a focus on pancreatic and bile duct cancers [2][20] Core Points and Arguments - **Commercialization and Revenue Generation**: RenovoRx has begun commercializing its device, generating approximately $200,000 in revenue during its first full quarter of sales [15][18] - **Market Potential**: The potential peak revenue for the device in the U.S. is estimated at $400 million, with an initial target market of around 7,000 patients [3][6] - **Clinical Trials**: The company is conducting a pivotal phase three trial (TIGER PACT) for its drug-device combination, with positive interim results indicating a 65% reduction in side effects compared to traditional systemic chemotherapy [23][29] - **Physician Interest**: There is significant inbound interest from physicians, particularly for treating patients with pancreatic cancer, as the device offers a less toxic alternative to traditional chemotherapy [11][12][14] Financial and Growth Strategy - **Sales Strategy**: RenovoRx plans to leverage a small sales team to target approximately 200 high-volume cancer treatment centers in the U.S., minimizing the need for a large sales force [7][18] - **Revenue Growth Potential**: Each patient treated could represent multiple device sales, with potential revenues ranging from $6,000 to $9,000 per device, leading to significant revenue growth opportunities [17][18] - **Funding Research and Development**: The revenue from the catheter sales is expected to fund ongoing research and development activities, potentially leading to cash flow positivity [21][18] Clinical and Competitive Advantages - **Reduced Side Effects**: The localized delivery mechanism significantly reduces systemic side effects associated with traditional chemotherapy, improving patient quality of life [23][24] - **Survival Benefits**: Early data from trials suggest that patients may experience longer survival rates due to the effective delivery of chemotherapy directly to tumors [25][29] Upcoming Catalysts - **Second Interim Analysis**: The second interim analysis of the TIGER PACT trial is expected in the third quarter of 2025, which will provide further insights into the trial's progress and potential outcomes [30][32] - **Insider Confidence**: Management has shown confidence in the company's future by purchasing shares in the open market, indicating belief in the company's undervaluation [34] Additional Insights - **Market Positioning**: RenovoRx is positioned favorably compared to analogs like Delcath and NovoCure, with management believing the company is undervalued in the current market [34] - **Optionality in Strategy**: The company has the flexibility to pivot between focusing on catheter sales or advancing drug-device combinations based on market conditions and trial outcomes [22]

Core Viewpoint - RenovoRx, Inc. is conducting its Q1 2025 earnings conference call, highlighting its financial and operational performance, with key leadership present to discuss the company's progress and future outlook [1][2]. Group 1: Company Leadership and Structure - The conference call features RenovoRx's leadership team, including Dr. Ramtin Agah (Founder and Chief Medical Officer), Shaun Bagai (CEO), and Ronald Kocak (VP Controller and Principal Accounting Officer) [2]. Group 2: Forward-Looking Statements - The company emphasizes that statements made during the call may be considered forward-looking, reflecting management's current views on market conditions and potential outcomes of clinical trials [3][4]. - Management's forward-looking statements are based on current plans and assumptions, which are subject to various risks and uncertainties [3].

Company Performance - RenovoRx, Inc. reported a quarterly loss of $0.08 per share, consistent with the Zacks Consensus Estimate, compared to a loss of $0.07 per share a year ago [1] - The company posted revenues of $0.2 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 1.50%, and this is an increase from zero revenues a year ago [2] - RenovoRx shares have declined approximately 18.6% since the beginning of the year, while the S&P 500 has gained 0.2% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.08 on revenues of $0.32 million, and for the current fiscal year, it is -$0.30 on revenues of $1.55 million [7] - The estimate revisions trend for RenovoRx is currently favorable, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which RenovoRx belongs, is currently ranked in the top 28% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8]

Financial Data and Key Metrics Changes - For Q1 2025, the company reported revenue of approximately $200,000 from commercial sales of its FDA cleared RenovoCast device, exceeding initial expectations [22] - Research and development expenses increased to $1,700,000 from $1,300,000 in Q1 2024, primarily due to higher employee compensation and increased manufacturing costs [22] - Selling, general and administrative expenses rose to approximately $1,600,000 from $1,200,000 in the prior year period, attributed to increased personnel costs and professional fees [22] - As of March 31, 2025, the company had $14,600,000 in cash and cash equivalents [23] Business Line Data and Key Metrics Changes - The company generated its first revenue from commercial sales of Renovocath, with $43,000 in revenue recorded in December 2024 and approximately $200,000 in Q1 2025 [12][22] - There is strong organic demand for Renovocath, with over 10 medical institutions initiating purchase orders [13] - The initial total addressable market for Renovocath is estimated at $400,000,000 in peak U.S. annual sales opportunity [14] Market Data and Key Metrics Changes - The company anticipates sequential quarter-over-quarter revenue growth for Renovocath throughout the year, driven by demand from oncology centers [13][21] - The company is exploring international markets but currently lacks a CE mark, focusing on the U.S. market first due to favorable reimbursement landscapes [28] Company Strategy and Development Direction - The company is focused on implementing a commercial strategy for Renovocath alongside ongoing clinical trials, aiming to establish a new standard of care for locally advanced pancreatic cancer [12][10] - The company plans to target the top 200 high-volume treatment centers for market penetration, potentially partnering with larger organizations for distribution [17][31] - The company is also exploring expansion opportunities across other cancer indications, which could significantly increase the total addressable market [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing Phase III TIGER PACT clinical trial, with expectations for full enrollment in 2025 [18] - The company is encouraged by the positive feedback from clinical investigators regarding the potential benefits of the Renovocath device [10] - Management believes that growing revenues from Renovocath will reduce the company's burn rate and support ongoing clinical trials [17] Other Important Information - The company announced the issuance of a new U.S. patent for its TAMP therapy platform, enhancing its intellectual property portfolio [19][20] - Management and board members purchased approximately 143,000 shares of Renovo Rx stock, signaling confidence in the company's future [20] Q&A Session Summary Question: Plans for Renovocast in international markets - The company is looking into obtaining a CE mark for future international markets, with high demand noted in Europe and Asia [28] Question: Sales strategy for targeting top cancer centers - The company is exploring both hiring a small sales force and partnering with strategic partners that have existing distribution channels [31]

Financial Data and Key Metrics Changes - For Q1 2025, the company reported revenue of approximately $200,000 from commercial sales of its FDA cleared RenovoCast device, exceeding initial expectations [22] - Research and development expenses increased to $1,700,000 from $1,300,000 in Q1 2024, primarily due to higher employee compensation and increased manufacturing costs [22] - Selling, general and administrative expenses rose to approximately $1,600,000 from $1,200,000 in the prior year period, attributed to increased personnel costs and professional fees [22] - As of March 31, 2025, the company had $14,600,000 in cash and cash equivalents [23] Business Line Data and Key Metrics Changes - The company began generating revenue from commercial sales of Renovocath in Q1 2025, with purchase orders received ahead of schedule [12] - Revenue from Renovocath exceeded internal expectations, with approximately $200,000 generated in the first quarter [13] - The company anticipates sequential quarter-over-quarter revenue growth for Renovocath for the foreseeable future [13] Market Data and Key Metrics Changes - The initial total addressable market for Renovocath is estimated at $400,000,000 in peak U.S. annual sales opportunity [14] - The company expects expansion opportunities across other cancer indications, potentially leading to a multi-billion dollar U.S. total addressable market over time [15] Company Strategy and Development Direction - The company is focusing on implementing a commercial strategy for Renovocath alongside ongoing clinical trials [12] - Plans to target the top 200 high-volume treatment centers with a small yet focused commercial team [16] - The company is exploring partnerships with larger organizations that have established sales forces to enhance market penetration [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of the Renovocath device and the positive reception from the physician community [10] - The company aims to achieve full enrollment in the TIGER PACT trial during 2025, with ongoing efforts to target additional clinical sites [18] - Management highlighted the importance of the new U.S. patent for the TANF therapy platform in strengthening the company's competitive position [20] Other Important Information - The company announced that members of the management team and board purchased approximately 143,000 shares of Renovo Rx stock, signaling confidence in the company's future [20] - The company is actively exploring international market opportunities, particularly in Europe and Asia, but is currently focused on the U.S. market [29][30] Q&A Session Summary Question: Plans for Renovocast in international markets - The company is looking into obtaining a CE mark for future international markets, with high demand noted in Europe and Asia [29][30] Question: Plans for partnering with cancer centers - The company is considering both hiring a small sales force and partnering with strategic companies that have existing distribution channels to target top cancer centers [32]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ COMMISSION FILE NUMBER: 001-40738 RENOVORX, INC. (Exact name of registrant as specified in its charter) Delaware 27-1448452 (State or oth ...

[Business and Commercialization Update](index=1&type=section&id=Business%20and%20Commercialization%20Update) RenovoRx launched RenovoCath commercial sales in Q1 2025, exceeding expectations with initial revenue and projecting significant market expansion - Q1 2025 marked the first full quarter of RenovoCath commercial sales, generating approximately **$200,000** in revenue and surpassing internal forecasts[3](index=3&type=chunk)[4](index=4&type=chunk) - Over **ten** medical institutions have placed initial and repeat purchase orders for RenovoCath[5](index=5&type=chunk) - The initial U.S. total addressable market for RenovoCath is estimated at **$400 million** in peak annual sales, with potential to expand into a multi-billion-dollar market[6](index=6&type=chunk)[7](index=7&type=chunk) - Intellectual property strengthened with a new U.S. patent for the TAMP therapy platform, expanding the global portfolio to **19** patents[11](index=11&type=chunk) [Ongoing Pivotal Phase III TIGeR-PaC Trial Update](index=2&type=section&id=Ongoing%20Pivotal%20Phase%20III%20TIGeR-PaC%20Trial%20Update) The Phase III TIGeR-PaC trial is on track for full enrollment in 2025, with 91 patients randomized and a second interim analysis triggered - The Phase III TIGeR-PaC trial is on track for full enrollment in **2025**, with Johns Hopkins Medicine joining as a clinical site[8](index=8&type=chunk) TIGeR-PaC Trial Enrollment and Analysis Status (as of May 2, 2025) | Metric | Status | | :--- | :--- | | **Target Randomized Patients** | 114 | | **Patients Randomized** | 91 | | **Target Events for Final Analysis** | 86 | | **Events Occurred** | 56 | - The second interim analysis has been triggered, with Data Monitoring Committee review anticipated in **Q3 2025**[9](index=9&type=chunk) - Supportive pre-clinical and pharmacokinetic data for the TAMP therapy platform were presented at major oncology conferences including ASCO GI, SIO, and SSO[10](index=10&type=chunk) [Financial Highlights for the First Quarter Ended March 31, 2025](index=3&type=section&id=Financial%20Highlights%20for%20the%20First%20Quarter%20Ended%20March%2031%2C%202025) Q1 2025 saw RenovoRx's first commercial revenue of $200,000, a cash balance of $14.6 million, and an increased net loss due to commercialization and R&D investments Q1 2025 Key Financial Metrics | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | **Revenue** | ~$200 thousand | $0 | | **R&D Expenses** | $1.7 million | $1.3 million | | **SG&A Expenses** | $1.6 million | $1.2 million | | **Net Loss** | $2.4 million | $1.1 million | | **Cash & Cash Equivalents** | $14.6 million | N/A | - Cash balance of **$14.6 million** as of March 31, 2025, is expected to fund RenovoCath commercial scale-up and TIGeR-PaC trial completion[1](index=1&type=chunk)[16](index=16&type=chunk) Selected Balance Sheet Data (in thousands) | | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents** | $14,582 | $7,154 | | **Total assets** | $16,014 | $8,118 | | **Total liabilities** | $2,857 | $3,640 | | **Total stockholders' equity** | $13,157 | $4,478 | Selected Statement of Operations Data (in thousands, except per share data) | | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | **Revenues** | $197 | $ - | | **Gross profit** | $103 | $ - | | **Research and development** | $1,642 | $1,257 | | **Selling, general and administrative** | $1,571 | $1,219 | | **Loss from operations** | $(3,110) | $(2,476) | | **Net loss** | $(2,420) | $(1,076) | | **Net loss per share, basic and diluted** | $(0.08) | $(0.07) | [Corporate Overview and Conference Call](index=1&type=section&id=Corporate%20Overview%20and%20Conference%20Call) RenovoRx is a life sciences company advancing targeted oncology therapies and commercializing RenovoCath, with management demonstrating confidence through open market share purchases - RenovoRx is a life sciences company focused on developing targeted oncology therapies via its TAMP™ platform and commercializing the FDA-cleared RenovoCath device[2](index=2&type=chunk)[23](index=23&type=chunk) - Management and Board members purchased approximately **143,000** shares in open market transactions during Q1 2025[12](index=12&type=chunk) Conference Call Details | Event: | RenovoRx First Quarter 2025 Financial Results Conference Call | | :--- | :--- | | **Date:** | Thursday, May 15, 2025 | | **Time:** | 4:30 p.m. ET | | **Live Call:** | 1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International) |

Summary of RenovoRx (RNXT) Fireside Chat - April 29, 2025 Company Overview - **Company**: RenovoRx (RNXT) - **Product**: Renovocath, a novel FDA-cleared drug delivery device for cancer treatment, particularly for locally advanced pancreatic cancer - **Key Personnel**: Sean Beguy (CEO), Gregory Tisi (Medical Director at Hackensack Meridian) Industry Context - **Industry**: Cancer treatment and drug delivery devices - **Market Potential**: Estimated peak U.S. revenue of $400 million for Renovocath alone, with a focus on pancreatic cancer treatment Core Points and Arguments 1. **Commercialization Strategy**: The company has initiated commercialization efforts for Renovocath, with first purchase orders received in 2024 and expectations for strong demand in 2025 [8][10][22] 2. **Clinical Trial Progress**: Ongoing Phase III TIGER PACT trial for locally advanced pancreatic cancer, with interim analysis showing increased overall survival and reduced side effects [10][19][21] 3. **Mechanism of Action**: Renovocath utilizes a proprietary method called transarterial microperfusion to deliver chemotherapy directly to tumors, resulting in a 100 times increase in drug concentration at the tumor site compared to systemic delivery [12][13] 4. **Patient Outcomes**: Initial data indicates a six-month increase in survival compared to standard care, with a 65% reduction in side effects, leading to improved quality of life for patients [20][21] 5. **Financial Performance**: Reported initial revenues of $43,000 in Q4 2024, with guidance for low six-figure revenue in Q1 2025 and expectations for sequential growth [22][23] 6. **Reimbursement Landscape**: Recent changes in reimbursement codes have increased the potential revenue per procedure from $10,000 to $17,000, enhancing the business opportunity for RenovoRx [53] 7. **Market Demand**: High physician demand for the device has been noted, with hospitals expressing interest in purchasing Renovocath for patient treatment [10][26] Additional Important Insights 1. **Sales Strategy**: The company plans to operate with a lean sales force of 3-5 people, leveraging existing physician demand and partnerships with established distribution channels [30][31][17] 2. **Supply Chain Stability**: The device is manufactured in the U.S., mitigating risks associated with global supply chain issues [60][62] 3. **Future Opportunities**: The technology is adaptable for various drugs, including immunotherapies and gene editing therapies, which could expand its application in cancer treatment [40][42] 4. **Investor Sentiment**: The CEO expressed confidence that the stock is undervalued due to a lack of understanding of the commercial opportunity and anticipated growth in revenue as the company transitions to a commercial phase [69][72] Conclusion - RenovoRx is positioned to capitalize on a significant market opportunity in cancer treatment with its innovative Renovocath device, backed by promising clinical trial results and a strong commercialization strategy. The company aims to enhance patient care while achieving substantial revenue growth in the coming years.