First Registry-Eligible Patient Procedure Commenced at the University of Vermont Cancer Center Baptist Health Miami Cancer Institute and University of Pittsburgh Medical Center Join the University of Vermont Cancer Center as Participating Clinical Sites The PanTheR Study is Gathering Expanded Safety and Performance Data of the FDA-Cleared RenovoCath® Device and its Associated Survival Outcomes in Patients Diagnosed with Solid Tumors MOUNTAIN VIEW, Calif., Sept. 25, 2025 (GLOBE NEWSWIRE) -- RenovoRx, Inc. ( ...

Summary of RenovoRx Conference Call Company Overview - **Company**: RenovoRx (NasdaqCM:RNXT) - **Industry**: Medical Technology, specifically focused on cancer treatment and drug-device combinations Key Points and Arguments 1. **Advancements in Cancer Care**: RenovoRx is advancing medicine through innovative technologies aimed at reducing toxicity in cancer treatments while effectively targeting tumors [2][3] 2. **RenovoCath Device**: The FDA-cleared RenovoCath device has been commercialized, with revenues in the first half of the year exceeding expectations despite having no sales force in place [3][4] 3. **Market Opportunity**: The initial market opportunity for the RenovoCath device is estimated at $400 million, with potential for significant growth as the device is used in various cancer treatments [4][13] 4. **Clinical Trials**: The TIGeR-PaC phase III trial is focused on treating locally advanced pancreatic cancer, with enrollment nearing completion [4][16] 5. **Mechanism of Action**: The RenovoCath device utilizes Transarterial Microperfusion (TAMP) to deliver chemotherapy directly to tumors, particularly those that are hypovascular and resistant to systemic treatments [5][6][12] 6. **Patient Experience**: The treatment procedure is outpatient, takes about 90 minutes, and does not require general anesthesia, leading to a better quality of life for patients [10][11] 7. **Survival Benefits**: Interim analysis from the TIGeR-PaC trial shows a six-month survival benefit for patients treated with the RenovoCath device compared to standard treatments, along with a 65% reduction in adverse events [22][23] 8. **Commercial Strategy**: RenovoRx plans to expand its commercial efforts with a small, efficient sales team targeting high-volume surgical centers and academic institutions [15][16] 9. **Financial Health**: The company reported $600,000 in revenue in the first half of the year and has a cash reserve of $12.3 million, which is expected to last into late 2026 [16][28] 10. **Patent Protection**: RenovoRx holds over 19 issued patents worldwide, ensuring protection for its technology and innovations [14] Additional Important Content 1. **Future Trials and Indications**: There is interest in expanding the use of the RenovoCath device to other cancers, including cholangiocarcinoma and non-small cell lung cancer [30][32] 2. **Metrics for Commercial Traction**: The company is focusing on the number of centers approved to use the device and the volume of patients treated, rather than just revenue figures [32][33] 3. **Partnership Opportunities**: RenovoRx is in discussions with potential partners, including Boston Scientific, to scale commercial efforts and explore acquisition possibilities [37][39] 4. **Regulatory Pathway**: The company anticipates engaging with the FDA for an accelerated approval pathway based on the positive survival and safety signals from the TIGeR-PaC trial [40] This summary encapsulates the key insights from the RenovoRx conference call, highlighting the company's innovative approach to cancer treatment, market potential, and strategic plans for growth and commercialization.

Core Viewpoint - RenovoRx, Inc. is actively commercializing its FDA-cleared drug-delivery device, RenovoCath, and is presenting at the iAccess Alpha Virtual Best Ideas Fall Investment Conference to discuss its commercialization efforts and ongoing clinical trials [1][2][3] Company Overview - RenovoRx, Inc. is a life sciences company focused on developing targeted oncology therapies and commercializing RenovoCath, a patented drug-delivery device that addresses high unmet medical needs [6] - The company utilizes its Trans-Arterial Micro-Perfusion (TAMP™) therapy platform for targeted therapeutic delivery, aiming to improve safety and efficacy compared to traditional systemic therapies [6] Commercialization Efforts - The company has received its first commercial purchase orders for RenovoCath devices as of December 2024, with several customers initiating repeat orders [9] - RenovoRx is expanding its customer base, including high-volume National Cancer Institute-designated centers, to meet anticipated demand for RenovoCath [10] Clinical Trials - The ongoing Phase III TIGeR-PaC clinical trial is evaluating the intra-arterial gemcitabine delivered via RenovoCath for treating locally advanced pancreatic cancer (LAPC) [3][7] - The Data Monitoring Committee has recommended continuing the trial after reviewing a second pre-planned interim analysis triggered by 52 deaths [3] Product Information - RenovoCath is designed for isolating blood flow and delivering fluids to specific sites in the peripheral vascular system, with applications including temporary vessel occlusion and chemotherapeutic drug infusion [5] - The combination product candidate, IAG, which uses RenovoCath, has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, providing seven years of market exclusivity upon FDA approval [8]

Core Viewpoint - Biotech stocks are experiencing renewed momentum, with small-cap companies like Nautilus Biotechnology, PepGen, Lixte, RenovoRx, Genelux, and VolitionRx attracting investor interest through various catalysts such as insider buying, strategic partnerships, and clinical trial progress Group 1: Nautilus Biotechnology (NAUT) - Nautilus Biotechnology's stock surged 5.52% during regular trading, closing at $0.7070, and rose an additional 7.5% in after-hours trading to $0.76, with trading volume nearly double its average at 647,399 shares [2] - Recent insider buying by CEO Sujal M. Patel, who purchased 83,500 shares on September 8 and 116,500 shares on September 5, totaling over $135,000, indicates strong leadership confidence [3] - The company reported a narrower loss of $0.12 per share in Q2 2025, with an 18% drop in operating expenses, and has $179.5 million in cash, providing a financial runway through 2027 [4] Group 2: PepGen Inc. (PEPG) - PepGen's stock rebounded 7.14% in after-hours trading to $1.50 after a regular session close of $1.40, with trading volume more than double its average at 638,576 shares [4] - The company completed dosing for its 15 mg/kg arm of the FREEDOM trial, with topline data expected in early Q4 2025, following a strategic narrowing of its pipeline [5] Group 3: Lixte Biotechnology Holdings Inc. (LIXT) - Lixte's stock rose 5.85% in after-hours trading to $5.25 after closing at $4.96, with a trading volume of 503,604 shares, notable given recent volatility [5] - The company announced a $2.6 million purchase of Bitcoin and Ethereum to diversify its treasury holdings, reflecting a strategic shift in financial strategy [6] Group 4: RenovoRx Inc. (RNXT) - RenovoRx shares increased 4.22% in after-hours trading to $1.2194 after a regular session close of $1.17, with trading volume significantly above its average at 886,119 shares [6] - The company received a positive recommendation to continue its Phase III TIGeR-PaC trial for pancreatic cancer, reinforcing confidence in its lead therapy platform [7] Group 5: Genelux Corp. (GNLX) - Genelux's stock rose 4.11% in after-hours trading to $3.80 after closing at $3.65, with trading volume relatively light at 60,339 shares [8] - The recent activity follows Genelux's participation in the H.C. Wainwright Global Investment Conference [9] Group 6: VolitionRx Ltd. (VNRX) - VolitionRx's stock increased 4.27% in after-hours trading to $0.6474 after closing at $0.6209, with trading volume slightly below its average at 183,777 shares [10] - The company announced a Research License and Exclusive Commercial Option Rights Agreement with Werfen's Immunoassay Technology Center, focusing on advancing its Nu.Q NETs assay for Antiphospholipid Syndrome [10]

Summary of the Conference Call Company Overview - **Company**: RenovoRx - **Industry**: Targeted Oncology - **Product**: RenovoCath, a device for targeted delivery of therapeutics, particularly for difficult-to-treat cancers like locally advanced pancreatic cancer [1][4][6] Core Points and Arguments - **Business Model**: RenovoRx operates on a dual-track model, focusing on both the commercialization of the RenovoCath device and late-stage Phase III clinical trials for drug-device combinations [6][8] - **Transarterial Microperfusion (TAMP)**: The patented technology allows for localized delivery of chemotherapy, minimizing systemic side effects. The device is FDA-cleared and designed to deliver chemotherapy directly to tumor sites [6][10][26] - **Clinical Trials**: The ongoing Phase III TIGeR-PaC trial is evaluating the efficacy of the RenovoCath device combined with gemcitabine for treating locally advanced pancreatic cancer. The trial has shown promising interim results, including a 30% survival benefit and a 65% reduction in side effects compared to standard care [7][31][36] - **Market Demand**: There is significant physician interest in the device due to its potential to reduce toxicities and improve patient outcomes. The company has initiated commercialization based on physician demand [11][12][23] Financial Insights - **Revenue Potential**: Each patient may require 5 to 10 treatments, leading to substantial revenue potential. The price range for the device is estimated between $6,000 to $8,500, with potential revenue of around $100,000 per patient [22][23] - **Cash Position**: The company reported $12.3 million in cash with a burn rate of approximately $800,000 per month, providing a runway into the second half of 2026 [45] Additional Important Content - **PANTHER Registry**: A post-market registry study to capture data on the device's use across various tumor types, which may lead to expanded indications for the drug-device combination [16][19] - **Regulatory Pathway**: The company anticipates that the TIGeR-PaC study could serve as a pivotal trial for FDA approval, with a focus on overall survival as the primary endpoint [39][40] - **Future Catalysts**: Key upcoming events include the publication of pharmacokinetic data, updates from the PANTHER registry, and commercial progress as the company builds its sales team [42][44] Conclusion RenovoRx is positioned to capitalize on a unique market opportunity with its innovative device for targeted cancer therapy. The ongoing clinical trials and commercial efforts are expected to drive growth and enhance patient outcomes in oncology.

Company Performance - RenovoRx, Inc. reported a quarterly loss of $0.08 per share, consistent with the Zacks Consensus Estimate, compared to a loss of $0.10 per share a year ago [1] - The company posted revenues of $0.42 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 22.32%, and showing a significant increase from zero revenues a year ago [2] - Over the last four quarters, RenovoRx has surpassed consensus EPS estimates two times [1] Stock Performance - RenovoRx shares have declined approximately 5.4% since the beginning of the year, while the S&P 500 has gained 10% [3] - The current Zacks Rank for RenovoRx is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.08 on revenues of $0.44 million, and for the current fiscal year, it is -$0.32 on revenues of $1.61 million [7] - The trend of estimate revisions for RenovoRx was mixed ahead of the earnings release, which could change following the recent report [6] Industry Context - RenovoRx operates within the Medical - Biomedical and Genetics industry, which is currently ranked in the bottom 41% of over 250 Zacks industries [8] - Research indicates that the top 50% of Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1 [8]

Financial Data and Key Metrics Changes - For the second quarter of 2025, the company reported revenues of approximately $422,000 from commercial sales of the RenovaCATH device, driven by new customer purchase orders and early repeat orders [17] - Research and development expenses were $1.4 million, reflecting a $100,000 decrease from the same quarter year over year [17] - The company ended the quarter with $12.3 million in cash and cash equivalents [17] Business Line Data and Key Metrics Changes - The RenovaCATH device achieved over $400,000 in sales in the second quarter, marking a significant accomplishment shortly after its launch [7][11] - The company has randomized 95 patients in the Phase three TIGER PACT trial, with 61 events occurring, keeping it on track to complete enrollment later this year or early next year [10][13] Market Data and Key Metrics Changes - The initial U.S. total addressable market for the RenovaCATH device is estimated at $400 million in peak annual sales opportunity [12] - The company believes there is potential for a several billion dollar total addressable market as it expands into additional cancer applications [12] Company Strategy and Development Direction - The company aims to transform patient outcomes through safer, more effective targeted therapy, particularly for difficult-to-treat cancers like locally advanced pancreatic cancer [10] - The company is focused on building commercialization momentum while maintaining a lean operational structure [11] - The company plans to explore international markets after establishing a strong presence in the U.S. [41] Management's Comments on Operating Environment and Future Outlook - Management expressed excitement about the positive recommendation from the independent data monitoring committee (DMC) to continue the TIGER PACT trial, indicating confidence in the trial's potential outcomes [9][13] - The company anticipates a ramp-up in enrollment pace due to the addition of larger cancer centers [29] Other Important Information - The company launched a multicenter post-marketing registry study called PANTHER to evaluate the safety and effectiveness of the RenovaCATH device in real-world clinical settings [14] - The company is exploring the use of the RenovaCATH device for various solid tumors beyond pancreatic cancer, including cholangiocarcinoma and non-small cell lung cancer [52][53] Q&A Session Summary Question: Clarification on trial patient numbers - Management confirmed that the DMC's feedback was positive, and the trial will maintain the same sample size without adding patients [22] Question: Timing for data from the PANTHER trial - Management indicated that data from the PANTHER study will be published as interesting findings arise, without a specific timeline [31] Question: Update on partnerships with top cancer centers - Management reported that they are currently in 13 hospitals with approvals to purchase the device, with four centers already treating patients [39] Question: Revenue from clinical studies vs. commercial sales - Management clarified that the reported revenue of $422,000 is from new customers outside of the clinical trial, with no revenue recognized from the TIGER PACT trial [46] Question: Plans for international market expansion - Management stated that while the focus is currently on the U.S. market, there are plans to explore international opportunities in the future [41] Question: Gross margins sustainability - Management expressed confidence that gross margins could increase towards the 70% to 90% range as the company scales [72] Question: Future revenue expectations - Management anticipates growth throughout the year, with a significant ramp-up expected in 2026 as the sales team is fully established [76]

[Business Highlights and Operational Updates](index=1&type=section&id=Business%20Highlights%20and%20Operational%20Updates) RenovoRx reported significant progress in the second quarter of 2025, highlighted by initial commercial revenue from its RenovoCath device and a positive recommendation from the Data Monitoring Committee (DMC) to continue its pivotal Phase III TIGeR-PaC trial [RenovoCath Commercialization](index=1&type=section&id=RenovoCath%20Commercialization) The company achieved over $400,000 in revenue from RenovoCath sales in Q2 2025, marking its second full quarter of commercial activity, expanding its customer base and sales team | Metric | Value | Period | | :--- | :--- | :--- | | Commercial Revenue | > $400,000 | Q2 2025 | - The number of cancer centers approved to purchase RenovoCath increased to **thirteen**, up from **five** in the first quarter of 2025, with all **four** centers that have used the device making repeat purchase orders[5](index=5&type=chunk)[11](index=11&type=chunk) - The initial total addressable market (TAM) for RenovoCath is estimated at a **$400 million** peak annual U.S. sales opportunity, with potential to expand into a **multi-billion dollar** market with additional applications[6](index=6&type=chunk) - Hired Philip Stocton as Senior Director of Sales and Market Development to expand commercial efforts[2](index=2&type=chunk)[13](index=13&type=chunk) [Pivotal Phase III TIGeR-PaC Trial Update](index=1&type=section&id=Pivotal%20Phase%20III%20TIGeR-PaC%20Trial%20Update) The independent Data Monitoring Committee (DMC) recommended the continuation of the Phase III TIGeR-PaC trial, with 95 of 114 patients randomized as of August 12, 2025 - The independent Data Monitoring Committee (DMC) recommended the continuation of the Phase III TIGeR-PaC trial following a review of the second pre-planned interim analysis[3](index=3&type=chunk)[9](index=9&type=chunk) - The company will defer publishing the second interim data to preserve the integrity of the trial, with plans to revisit publication upon study completion[4](index=4&type=chunk)[9](index=9&type=chunk) | Trial Progress | Current Status (as of Aug 12, 2025) | Target for Final Analysis | | :--- | :--- | :--- | | Randomized Patients | 95 | 114 | | Events (Deaths) | 61 | 86 | [Other Key Developments](index=3&type=section&id=Other%20Key%20Developments) RenovoRx expanded its patent protection for the TAMP therapy platform, initiated a post-marketing registry study, and added Johns Hopkins Medicine as a new clinical trial site - Received U.S. patent **No. 12,290,564**, titled "Methods for Treating Tumors," which expands protection for the TAMP therapy platform through **November 2037**[15](index=15&type=chunk) - Launched the PanTheR study, a multi-center post-marketing observational registry to evaluate the safety and effectiveness of RenovoCath in real-world clinical settings[16](index=16&type=chunk) - Initiated patient enrollment with Johns Hopkins Medicine for the Phase III TIGeR-PaC clinical trial[14](index=14&type=chunk) [Financial Performance](index=3&type=section&id=Financial%20Performance) For the second quarter of 2025, RenovoRx reported revenues of $422,000 and a net loss of $2.9 million, ending the quarter with a strong cash position of $12.3 million [Financial Highlights (Q2 2025)](index=3&type=section&id=Financial%20Highlights%20%28Q2%202025%29) RenovoRx generated $422,000 in revenue from RenovoCath sales, maintained stable operating expenses, and reported a net loss of $2.9 million, primarily due to a change in warrant liability fair value - As of June 30, 2025, the company had **$12.3 million** in cash and cash equivalents, believed to be sufficient to fund ongoing RenovoCath scale-up and progress in the TIGeR-PaC trial[1](index=1&type=chunk)[18](index=18&type=chunk) | Financial Metric | Q2 2025 | Q2 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $422,000 | $0 | +$422,000 | | R&D Expenses | $1.4 million | $1.5 million | -$0.1 million | | SG&A Expenses | $1.5 million | $1.5 million | Unchanged | | Net Loss | $2.9 million | $2.4 million | +$0.5 million | - The increase in net loss was primarily driven by a **$0.9 million** change in the fair value of the warrant liability, offset by a **$0.4 million** decrease in loss from operations[21](index=21&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) The unaudited financial statements show total assets of $13.6 million and total liabilities of $3.0 million as of June 30, 2025, with revenues of $422,000 and a net loss per share of ($0.08) for the quarter Selected Balance Sheet Data (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $12,314 | $7,154 | | Total assets | $13,643 | $8,118 | | Total liabilities | $3,002 | $3,640 | | Total stockholders' equity | $10,641 | $4,478 | Selected Statement of Operations Data (in thousands, except per share) | | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Revenues | $422 | $0 | | Gross profit | $270 | $0 | | Loss from operations | ($2,678) | ($3,034) | | Net loss | ($2,895) | ($2,389) | | Net loss per share | ($0.08) | ($0.10) | [Corporate Information](index=5&type=section&id=Corporate%20Information) This section provides details about RenovoRx's products, business focus, and standard legal disclaimers, including a cautionary note on forward-looking statements [About RenovoRx and RenovoCath](index=5&type=section&id=About%20RenovoRx%20and%20RenovoCath) RenovoRx is a life sciences company commercializing the FDA-cleared RenovoCath device and developing targeted oncology therapies via its patented Trans-Arterial Micro-Perfusion (TAMP™) platform - RenovoRx is a life sciences company focused on developing targeted oncology therapies and commercializing its FDA-cleared drug-delivery device, RenovoCath[30](index=30&type=chunk) - The TAMP™ therapy platform is designed for targeted therapeutic delivery across the arterial wall near a tumor, potentially minimizing systemic toxicities[30](index=30&type=chunk) - RenovoCath is FDA-cleared for the isolation of blood flow and delivery of fluids to selected sites in the peripheral vascular system, including for chemotherapeutic drug infusion[29](index=29&type=chunk) [Forward-Looking Statements](index=7&type=section&id=Forward-Looking%20Statements) This section contains a standard cautionary note advising that the press release includes forward-looking statements concerning clinical trials, commercialization plans, revenue generation, and product potential - The press release contains forward-looking statements regarding clinical trials, commercialization plans, and financial projections[35](index=35&type=chunk) - These statements are subject to numerous risks and uncertainties, including those related to clinical trial outcomes, regulatory approvals, commercial success, and financing needs[35](index=35&type=chunk)

[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]