{"success":true,"data":{"pressRelease":{"id":"117229","rtpr_id":"nGNX45Ks15","ticker":"RNXT","exchange":"NASDAQ","all_tickers":["RNXT"],"title":"RenovoRx Reports Record Second Quarter 2026 Results, Driven by Accelerating Commercial Adoption and 61% Sequential Quarterly Revenue Growth","author":"Globe Newswire","published_at":"2026-08-12T20:05:04.272Z","article_body":"Increases 2026 Annual Revenue Guidance to a Range of $3.75M to $4.25M\n\nFirst Treatment Delivered with RenovoCath(®) in Patient with Sarcoma in\nClinical Setting, Marking Expansion of Device to Other Solid Tumors\n\nPhase III TIGeR-PaC Trial Reaches Full Enrollment; Completion of Trial\nExpected in First Half 2027 with Topline Data Readout Expected in Second Half\n2027\n\nManagement to Host Conference Call Today at 4:30 p.m. ET\n\nMOUNTAIN VIEW, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- RenovoRx, Inc.\n(https://www.globenewswire.com/Tracker?data=joFnIP4Zr7pceNmPtBEPQ7hKbGV9bEMy_VYOqUhlzQ-4HTxXuN0dp_OHzQYGHoqTPPJzeg3aPt4u-uwwGMropg==)\n(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life-sciences company\ndeveloping innovative targeted oncology therapies and commercializing\nRenovoCath(®), a patented, FDA-cleared drug-delivery device, today announced\nits financial results for the second quarter ended June 30, 2026, and provided\nshareholders with a business update highlighting continued commercial momentum\nand clinical progress.\n\n“In the second quarter of 2026, we delivered record revenue and executed on\nall three of the milestones we set for the business: revenue growth with\nanother record revenue quarter, commercial momentum evidenced by several\ncancer center activations, and expansion of the application of our technology\nbeyond locally advanced pancreatic cancer (LAPC),” said Shaun Bagai, Chief\nExecutive Officer of RenovoRx. “We generated quarterly revenue of $909,000,\nan increase of approximately 61% compared to the first quarter of 2026, and\napproximately 115% compared to the second quarter of 2025. Our strong first\nhalf performance gives us confidence that our second half revenue will exceed\nour original full year forecast. This outlook is driven by more active\ncommercial cancer center customers, more patients treated via procedures with\nRenovoCath, and repeat ordering across our existing customer base.”\n\nMr. Bagai continued, “We ended the second quarter with 21 active commercial\ncancer center customers, an increase of more than 30% from the 16 centers\nreported at the time of our first quarter earnings call, and expanded our\ntotal commercial pipeline to 63 centers, including 42 additional centers\nprogressing through evaluation, approval, and activation. We continue to see\nmeaningful repeat utilization across our existing customer base, and for the\nfirst time, a treating physician chose RenovoCath to deliver therapy to a\npatient with a solid tumor beyond pancreatic cancer, marking an important,\nphysician-driven expansion of the clinical application of our TAMP\nplatform.”\n\n“Looking ahead, we remain focused on executing against both our near-term\ncommercial priorities and our long-term clinical objectives,” added Mr.\nBagai. “Based on current trends, we expect third quarter revenue to surpass\nsecond-quarter revenue and set another record. We remain on track to meet or\nexceed our target of 36 active commercial cancer center customers by year end\n2026.\"\n\n\"The recently announced enrollment completion of our Phase III TIGeR-PaC trial\npositions the majority of our trial sites to also transition to commercial use\nin the second half of the year. Reflecting our strong first half performance,\nwe are raising and tightening the range for our full year revenue guidance. In\nshort, we believe RenovoRx is building a durable, capital-efficient commercial\nbusiness,\" said Mr. Bagai. \"Management believe that reaching a quarterly\nrevenue run-rate of approximately $5 million would position RenovoRx at\ncash-flow break-even, and based on our current trajectory, our internal plan\nanticipates achieving break-even operations in the fourth quarter of 2027.\"\n\nRenovoCath Commercialization Update\nRenovoRx delivered its strongest quarterly revenue performance to date.\nRevenue totaled $909,000 for the second quarter, an increase of approximately\n61% compared to the first quarter of 2026 and approximately 115% compared to\nthe second quarter of 2025. Second quarter revenue alone represented\napproximately 83% of the Company’s total revenue generated in all of 2025.\nFor the six months ended June 30, 2026, revenue totaled approximately $1.5\nmillion. This growth reflects continued expansion of active commercial cancer\ncenter customers and increasing procedural utilization of RenovoCath across\nthe Company’s growing base of commercial sites.\n\nThe Company’s commercial model is currently focused on activating new cancer\ncenter customers, which have been a source of recurring demand. RenovoRx ended\nthe second quarter of 2026 with 21 active commercial cancer center customers,\nan increase of more than 30% from the 16 active customers reported at the time\nof the Company’s first quarter 2026 earnings call. RenovoRx is also\nadvancing a customer pipeline of 42 additional centers in various stages of\nevaluation, approval, or activation. Combined with its 21 active customers,\nthis represents a total of 63 centers in the Company’s commercial funnel, a\n31% increase compared to the 48 total centers reported on its first quarter\ncall. The Company remains on pace to meet or exceed its target of 36 active\ncommercial cancer center customers by year end 2026. In addition, 15 Phase III\nTIGeR-PaC clinical trial sites are positioned to transition to commercial\nRenovoCath use, several of which have already begun doing so. These sites\nrepresent an anticipated and meaningful contributor to revenue in the second\nhalf of 2026.\n\nRenovoRx continues to observe strong repeat ordering from existing customers,\nwhich the Company views as one of the clearest indicators of physician\nsatisfaction and clinical utility in interventional oncology. As physicians\nincorporate RenovoCath into routine clinical practice, repeat utilization is\nexpected to drive sustained revenue growth. Based on its current customer\npipeline and trends to date, the Company expects third quarter 2026 revenue to\nexceed second quarter revenue which would represent another consecutive record\nrevenue quarter.\n\nSince receiving FDA 510(k) clearance, RenovoCath has been used in more than\n900 successful procedures. RenovoRx continues to estimate that the initial\ntotal addressable market (TAM) for RenovoCath as a stand-alone device could\ntranslate into an approximately $400 million peak annual U.S. sales\nopportunity for RenovoRx. Over time, as the Company expands the platform into\nadditional solid tumor indications, the Company believes it could unlock more\nthan $1 billion in peak annual sales potential.\n\nExpansion of RenovoCath Beyond Locally Advanced Pancreatic Cancer\nIn early August 2026, RenovoRx announced the first commercial clinical use of\nRenovoCath by an existing cancer center customer in the treatment of sarcoma,\nmarking the expansion of its targeted drug-delivery device to solid tumors\nbeyond pancreatic cancer. The case involved a physician who had previously\ntreated LAPC patients using RenovoCath and returned to RenovoRx with a plan to\nuse the catheter to treat sarcoma. The Company views this physician-driven\nadoption as a meaningful endorsement of RenovoCath’s potential as a\nstandalone device across additional difficult-to-treat solid tumors within its\nFDA-cleared fields of use.\n\nOngoing Phase III TIGeR-PaC Trial Update\nRecently, RenovoRx announced that it achieved full enrollment in its Phase III\nTIGeR-PaC trial evaluating intra-arterial delivery of intra-arterial\ngemcitabine (IAG) via the RenovoCath device for the treatment of LAPC. This\nsignificant milestone reflects successful patient recruitment, clinical\nexecution, and collaboration among investigators and study teams evaluating\nIAG for LAPC, a difficult-to-treat cancer. The primary endpoint of the study\nis overall survival. TIGeR-PaC is designed to evaluate whether RenovoRx’s\npatented method of targeted delivery of the chemotherapy gemcitabine improves\npatient survival, safety, and tolerability compared to the standard of care\n(systemic (intravenous) chemotherapy gemcitabine + Abraxane).\n\nAs of August 7, 2026, TIGeR-PaC trial investigators have been notified by\nRenovoRx that patient enrollment is closing. Completion of the trial is\nexpected during the first half of 2027, after 86 events (i.e., patient deaths)\nhave been observed. As of August 11, 2026, 78 events have occurred. Following\ncompletion of the trial, initial topline trial data is expected to be\navailable during the second half of 2027.\n\nWith enrollment complete, RenovoRx is now focused on advancing toward final\ndata analysis. These efforts build on the successful completion of the second\ninterim analysis in 2025, after which the independent Data Monitoring\nCommittee recommended continuation of the trial without modification. To\npreserve trial integrity, the Company elected to defer publication of interim\ndata until study completion.\n\nRenovoRx continues to view TIGeR-PaC as a critical long-term value driver,\nwhile emphasizing that its current commercial strategy is independent of the\ntrial’s ultimate outcome and timeline.\n\nSecond Quarter 2026 and Subsequent Key Highlights\nRenovoRx continued to execute on its dual commercial and clinical strategy\nduring the second quarter of 2026 and the subsequent period, building\nreal-world evidence base for its TAMP platform.\n\nDuring the second quarter of 2026, several scientific data updates supported\nthe use of intra-arterial gemcitabine delivery via TAMP in LAPC. A\npeer-reviewed case study by researchers at Moffitt Cancer Center, published in\nRadiology Case Reports, found that PET-CT imaging, rather than CT alone,\nshowed a meaningful reduction in tumor metabolic activity after treatment.\nThese findings suggest that PET imaging may help optimize monitoring of\ntherapeutic response following TAMP-delivered treatment.\n\nIn addition, the PK sub-study of the TIGeR-PaC trial has been accepted and\nwill be published in the near future in the Journal of Cancer Chemotherapy and\nPharmacology. The findings support TAMP as a targeted delivery method for\ngemcitabine, demonstrating its potential to increase local drug potency while\nreducing systemic exposure and common side effects.\n\nFinally, a peer-reviewed case series in Case Reports in Oncology from\nresearchers at Hackensack Meridian Health’s Jersey Shore University’s\nMedical Center was accepted and will be published in the near future. The case\nseries highlights their experience with the TAMP procedure in LAPC.\n\nThe ramping up of publication of the TAMP procedure by physicians, the Company\nbelieves is another sign of adoption as TAMP traverses from an experimental\nprocedure to becoming a potential standard of care.\n\nCash Resources, History of Losses and Planned Activities\nRenovoRx continued to build the evidence base for its TAMP platform through a\nmulti-center post-marketing registry study generating real-world safety and\nefficacy data, as well as investigator-initiated trials (IITs) in borderline\nresectable and metastatic pancreatic cancer designed to achieve cost\nneutrality while broadening the platform’s evidence base. In the second\nquarter of 2026, the Company began supporting a new IIT in cholangiocarcinoma\n(bile duct cancer).\n\nRenovoRx received FDA Orphan Drug Designation for oxaliplatin in the treatment\nof pancreatic cancer in the second quarter of 2026, further expanding the\npotential applications of its targeted drug-delivery platform.\n\nFinancial Highlights for the Second Quarter Ended June 30, 2026\n* Revenue for the three months ended June 30, 2026 was $909,000, compared to\n$422,000 for the three months ended June 30, 2025. The increase was driven by\nthe continued commercialization of RenovoCath and expanding adoption across\nU.S. cancer centers.\n* Gross profit for the three months ended June 30, 2026 was $766,000,\nrepresenting a gross margin of approximately 84%, consistent with the\napproximately 85% gross margin in the first quarter of 2026 and reflecting the\nunderlying economics of RenovoCath.\n* Research and development expenses were approximately $1.2 million for the\nthree months ended June 30, 2026, compared to approximately $1.4 million for\nthe three months ended June 30, 2025.\n* Selling, general, and administrative expenses were approximately $2.9\nmillion for the three months ended June 30, 2026, compared to approximately\n$1.5 million for the three months ended June 30, 2025, a reflection of the\nCompany’s continued execution on its commercial infrastructure strategy.\n* Net loss for the three months ended June 30, 2026, was approximately $2.9\nmillion, compared to approximately $2.9 million for the three months ended\nJune 30, 2025. Net loss per share was $0.06 for the three months ended June\n30, 2026, compared to a net loss of $0.08 for the three months ended June 30,\n2025.\n* Cash and cash equivalents were approximately $9.5 million as of June 30,\n2026, compared to approximately $12.4 million as of March 31, 2026. This\nevidences the disciplined deployment of capital raised in the Company’s\nMarch 2026 private placement. The Company believes its current cash resources\nare sufficient to fund operations into the second half of 2027.\n* Shares Outstanding: As of June 30, 2026, common shares outstanding totaled\n45,121,982.\n* Guidance: RenovoRx is raising and tightening the range of its full-year 2026\nrevenue guidance to a range of $3.75 million to $4.25 million, from its prior\nrange of $3.0 million to $4.0 million. The updated guidance implies\nyear-over-year revenue growth of approximately 241% to 286% compared to\nfull-year 2025 revenue of $1.1 million.\n Conference Call Details                                                                             \n Event:      RenovoRx Second Quarter 2026 Financial Results and Business Highlights Conference Call  \n Date:       Wednesday, August 12, 2026                                                              \n Time:       4:30 p.m. ET                                                                            \n Live Call:  1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)                       \n Webcast:    https://ir.renovorx.com/news-events/ir-calendar-events                                  \n\nFor interested individuals unable to join the conference call, a link to the\nrecording will be available on RenovoRx’s Investor Relations website\n(https://www.globenewswire.com/Tracker?data=7yJm9dJrYUvDkaZk6SyiVxr0FDAfWQS3SRHKQMB50sDub0OT2B8DdCA6WMorKc5JL91TDx_DuzCq_ir_maBv7wDsTRSXex-Zd39X3msmmVY=),\nand a dial-in replay will be available until August 26, 2026, and can be\naccessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671\n(International) and entering replay pin number 13761368.\n\nA question and answer session will occur at the end of the call, and a link to\nthe recording of this presentation will be available on RenovoRx’s Investor\nRelations website\n(https://www.globenewswire.com/Tracker?data=7yJm9dJrYUvDkaZk6SyiVxr0FDAfWQS3SRHKQMB50sD7mR87-M0Gf1Sha2qZdzsxqr4oOruPLpAvSq2EvJ6xPEKnbY6qd4FMoQUKcxl3-bY=)\nafter the event.\n\n RENOVORX, INC.                                                                                                                                                         \n CONDENSED STATEMENTS OF OPERATIONS                                                                                                                                     \n (Unaudited)                                                                                                                                                            \n (Dollar in thousands, except per share amounts)                                                                                                                        \n                                                                Three Months Ended June 30,                         Six Months Ended June 30,                           \n                                                                       2026                      2025                      2026                      2025               \n Revenues                                                       $      909                $      422                $      1,472              $      619                \n Cost of revenues                                                      143                       152                       227                       246                \n Gross profit                                                   $      766                $      270                $      1,245              $      373                \n                                                                       84.3        %             64.0        %             84.6        %             60.3        %      \n Operating expenses:                                                                                                                                                    \n Research and development                                              1,200                     1,426                     2,428                     3,068              \n Selling, general and administrative                                   2,915                     1,522                     5,635                     3,093              \n Total operating expenses                                              4,115                     2,948                     8,063                     6,161              \n                                                                                                                                                                        \n Income/(loss) from operations                                         (3,349      )             (2,678      )             (6,818      )             (5,788      )      \n                                                                                                                                                                        \n Other income (expense), net:                                                                                                                                           \n Interest income, net                                                  90                        133                       134                       239                \n Loss on disposition of asset                                          (2          )             —                         (2          )             —                  \n Change in fair value of common warrant liability                      350                       (350        )             254                       234                \n Total other income (expense), net                                     438                       (217        )             386                       473                \n                                                                                                                                                                        \n Net loss                                                       $      (2,911      )      $      (2,895      )      $      (6,432      )      $      (5,315      )      \n Net loss per share                                                                                                                                                     \n Basic and diluted                                              $      (0.06       )      $      (0.08       )      $      (0.15       )      $      (0.16       )      \n Weighted-average shares used in computing net loss per share:                                                                                                          \n Basic and diluted                                                     47,298,148                36,576,567                42,690,881                34,000,539         \n\n\n\n RENOVORX, INC.                                                                                                                                                         \n RECONCILIATION OF GAAP NET INCOME/(LOSS)                                                                                                                               \n TO NON-GAAP NET INCOME                                                                                                                                                 \n (Unaudited)                                                                                                                                                            \n (Dollar in thousands, except per share amounts)                                                                                                                        \n                                                                Three Months Ended June 30,                         Six Months Ended June 30,                           \n                                                                       2026                      2025                      2026                      2025               \n GAAP net income                                                $      (2,911      )      $      (2,895      )      $      (6,432      )      $      (5,315      )      \n                                                                                                                                                                        \n Share-based compensation expense:                                                                                                                                      \n Research and development                                              216                       106                       327                       243                \n Selling, general and administrative                                   354                       239                       560                       390                \n Total share-based compensation expense                                570                       345                       887                       633                \n                                                                                                                                                                        \n Non-GAAP net income                                            $      (2,341      )      $      (2,550      )      $      (5,545      )      $      (4,682      )      \n                                                                                                                                                                        \n GAAP basic earnings per share                                  $      (0.06       )      $      (0.08       )      $      (0.15       )      $      (0.16       )      \n Effect of non-GAAP adjustments on basic earnings per share            0.01                      0.01                      0.02                      0.02               \n Non-GAAP basic earnings per share                              $      (0.05       )      $      (0.07       )      $      (0.13       )      $      (0.14       )      \n                                                                                                                                                                        \n Weighted-average shares used in computing net loss per share:                                                                                                          \n Basic and diluted                                                     47,298,148                36,576,567                42,690,881                34,000,539         \n\n\n\n RENOVORX, INC.                                                                             \n CONDENSED BALANCE SHEETS                                                                   \n (Unaudited)                                                                                \n (Dollar in thousands)                                                                      \n                                                    June 30,              December 31,      \n                                                    2026                  2025              \n                                                                                            \n Assets                                                                                     \n Current assets:                                                                            \n Cash and cash equivalents                          $    9,479         $  7,024             \n Accounts receivable, net                                480              139               \n Inventory                                               383              189               \n Prepaid expenses                                        315              324               \n Other current assets                                    153              217               \n Total current assets                                    10,810           7,893             \n                                                                                            \n Operating lease right-of-use asset                      368              190               \n Property and equipment, net                             94               12                \n Other non-current assets                                200              —                 \n Total assets                                       $    11,472        $  8,095             \n                                                                                            \n Liabilities and stockholders’ equity                                                       \n Current liabilities:                                                                       \n Accounts payable                                   $    866           $  799               \n Accrued expenses and other current liabilities          1,018            1,163             \n Total current liabilities                               1,884            1,962             \n                                                                                            \n Common stock warrant liability                          350              604               \n Operating lease liability, net of current portion       259              107               \n Total liabilities                                  $    2,493         $  2,673             \n                                                                                            \n Stockholders’ equity:                                                                      \n Common stock                                            5                4                 \n Additional paid-in capital                              76,793           66,805            \n Accumulated deficit                                     (67,819  )       (61,387  )        \n Total stockholders’ equity                              8,979            5,422             \n Total liabilities and stockholders’ equity         $    11,472        $  8,095             \n\nAbout RenovoCath\nBased on its FDA clearance, RenovoCath(®) is intended for the isolation of\nblood flow and delivery of fluids, including diagnostic and/or therapeutic\nagents, to select sites in the peripheral vascular system. RenovoCath is also\nindicated for temporary vessel occlusion in applications including\narteriography, preoperative occlusion, and chemotherapeutic drug infusion. For\nfurther information regarding our RenovoCath Instructions for Use (“IFU”),\nplease see:\nhttps://renovorx.com/wp-content/uploads/2026/06/IFU-10004-Rev.-H-Universal-IFU.pdf.\n\nAbout RenovoRx, Inc.\nRenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing\ninnovative targeted oncology therapies and commercializing RenovoCath(®), a\npatented, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery\ndevice, targeting high unmet medical needs. RenovoRx’s\npatented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is\ndesigned for targeted therapeutic delivery across the arterial wall near the\ntumor site to bathe the target tumor, while potentially minimizing a\ntherapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel\napproach to targeted treatment offers the potential for increased safety,\ntolerance, and improved efficacy, and its mission is to transform the lives of\ncancer patients by providing innovative solutions to enable targeted delivery\nof diagnostic and therapeutic agents.\n\nRenovoRx is actively commercializing its TAMP technology and FDA-cleared\nRenovoCath as a standalone device. For its first full year of commercial\nefforts in 2025, RenovoRx generated approximately $1.1 million in RenovoCath\nsales and a record $563,000 of sales in the first quarter of 2026. RenovoRx is\nactively working to expand the number of medical institutions initiating new\nRenovoCath orders, including esteemed, high-volume National Cancer\nInstitute-designated centers.\n\nRenovoRx is also evaluating its novel drug-device combination oncology product\ncandidate intra-arterial gemcitabine delivered via RenovoCath, (known as IAG)\nin the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center\nfor Drug Evaluation and Research (the drug division of the FDA) under a U.S.\ninvestigational new drug application that is regulated by the FDA’s 21 CFR\n312 pathway. IAG utilizes RenovoCath, which is FDA-cleared for temporary\nvessel occlusion in applications including arteriography, preoperative\nocclusion, and chemotherapeutic drug infusion. RenovoRx achieved full\nenrollment in the TIGeR-PaC trial in August 2026, with completion of trial\nexpected in first half 2027 and with topline data readout expected in second\nhalf 2027.\n\nThe IAG combination product candidate, enabled by the RenovoCath device, is\ncurrently under investigation and has not been approved for commercial sale.\nRenovoCath with gemcitabine received Orphan Drug Designation for pancreatic\ncancer and bile duct cancer, which provides seven years of market exclusivity\nupon new drug application approval by the FDA.\n\nFor more information, visit www.renovorx.com. Follow RenovoRx on Facebook\n(https://www.globenewswire.com/Tracker?data=lgbR4NmMA9iuCcOMOG5bwt9iQHceCDPxWQnwKoCfjhdxDHFR-123axd4vnSB2la0NtOuDDmwQzaW-jLM4Hdvwc0Hte8P-FtT59XjTkgJZqk=), LinkedIn\n(https://www.globenewswire.com/Tracker?data=6f0S4jT2EKpzF31mXe3E4fMjAFHf5Dpn2YU0PO7MRzGILwdMPd9myQY42d-oyEnpqCFuNIZWbimUWjofxExnZ-NKBcBFLF6jDmZkkpK1ZmYxnOScnEcISpdgdlqieAQr),\nand X\n(https://www.globenewswire.com/Tracker?data=MFQ9zInOCDj3vGbtVQsOblOBtZXxSP4XMez9b-OnrH5MAQa6nBHHFYDRQoLgkNbY0uwquM4aXqL2kPYFk67mfw==).\n\nNon-GAAP Financial Measures\nIn addition to reporting financial results in accordance with U.S. generally\naccepted accounting principles (“GAAP”), the operating results presented\nin the accompanying tables include certain non-GAAP financial measures that\nexclude the non-cash expense associated with share-based compensation.\n\nWe are providing such non-GAAP financial information in this press release,\nincluding non-GAAP operating expenses, net income (loss), and earnings (loss)\nper share, as a supplement to our consolidated financial statements prepared\nin accordance with GAAP which appear in this press release and in our\nQuarterly Report on Form 10-Q for the quarter ended June 30, 2026 as filed\nwith the U.S. Securities and Exchange Commission. Our management uses these\nnon-GAAP measures internally to analyze financial results, evaluate\noperational performance, and assess liquidity. We believe that both management\nand investors benefit from referring to these non-GAAP measures when assessing\nperformance and when planning, forecasting, and analyzing future periods.\n\nWe believe these non-GAAP measures also enhance investors’ understanding of\nkey financial metrics used in operational decision-making and are useful for\ncomparing our performance to that of other companies. However, readers are\ncautioned that non-GAAP results are presented for supplemental information\npurposes only and should not be considered a substitute for GAAP financial\ninformation. These measures may differ from similarly titled non-GAAP measures\npresented by other companies. Moreover, non-GAAP financial measures are not\nrequired to be uniformly applied and are not audited.\n\nCautionary Note Regarding Forward-Looking Statements\nThis press release and statements of the Company’s management and third\nparties made in connection therewith contain forward-looking statements within\nthe meaning of Section 27A of the Securities Act of 1933, and Section 21E of\nthe Securities Exchange Act of 1934, including but not limited to statements\nregarding (i) our clinical trials and studies (including expectations for full\nenrollment and data read out), (ii) the potential for our product candidates\nto treat or provide clinically meaningful outcomes for certain medical\nconditions or diseases, and (iii) our efforts to commercialize our RenovoCath\nand TAMP technology for use in treating pancreatic and other solid tumor\ncancers, and our expected financial results from such efforts, including our\nestimates for 2026 annual revenue. Statements that are not purely historical\nare forward-looking statements. The forward-looking statements contained\nherein are based upon our current expectations and beliefs regarding future\nevents, many of which, by their nature, are inherently uncertain, outside of\nour control, and involve assumptions that may never materialize or may prove\nto be incorrect. These may include estimates, projections, and statements\nrelating to our research and development plans, commercial and other business\nplans, intellectual property development, clinical trials, our therapy\nplatform, financing plans, objectives, and expected operating results, all of\nwhich are based on current expectations and assumptions that are subject to\nsignificant known and unknown risks and uncertainties that may cause actual\nresults to differ materially and adversely from those expressed or implied by\nthese forward-looking statements. These statements may be identified using\nwords such as “may,” “expects,” “plans,” “aims,”\n“anticipates,” “believes,” “forecasts,” “aim,” “goal,”\n“estimates,” “intends,” and “potential,” or derivatives of these\nterms or other comparable terminology regarding RenovoRx’s statements about\nthe future, although not all forward-looking statements contain these words.\nThese forward-looking statements are subject to a number of risks,\nuncertainties and assumptions, that could cause actual events to differ\nmaterially from those projected or indicated by such statements, including,\namong other things: (i) the risk that our commercial efforts our TAMP\ntechnology (enabled by RenovoCath) may not lead to the achievement of our\nrevenue forecasts or to viable, revenue generating operations in general; (ii)\ncircumstances which would adversely impact our ability to efficiently utilize\nour cash resources on hand or raise additional funding; (iii) the timing of\nthe initiation, progress, completion and potential results (including the\nresults of interim analyses) of our preclinical studies, clinical trials, and\nour research programs (notably with respect to our TIGeR-PaC trial); (iv) the\npossibility that interim results may not be predictive of the outcome of our\nclinical trials, which may not demonstrate sufficient safety and efficacy to\nsupport regulatory approval of our product candidate; (v) that applicable\nregulatory authorities may disagree with our interpretation of the data,\nresearch, and clinical development plans and timelines, and the regulatory\nprocess for our product candidates; (vi) future potential regulatory\nmilestones for our product candidates, including those related to current and\nplanned clinical studies; (vii) our ability to use and expand our therapy\nplatform to build a pipeline of product candidates; (viii) our ability to\nadvance product candidates into, and successfully complete, clinical trials;\n(ix) the timing or likelihood of regulatory filings and approvals; (x) our\nestimates of the number of patients who suffer from the diseases we are\ntargeting and the number of patients that may enroll in our clinical trials;\n(xi) the commercialization potential of our product candidates, if approved;\n(xii) our ability and the potential to successfully manufacture and supply our\nproduct candidates for clinical trials and for commercial use, if approved;\n(xiii) future strategic arrangements and/or collaborations and the potential\nbenefits of such arrangements; (xiv) our estimates regarding expenses, future\nrevenue, capital requirements, needs for additional financing, our ability to\nobtain additional capital and our ability to maintain the listing of our\ncommon stock on Nasdaq; (xv) the sufficiency of our existing cash and cash\nequivalents to fund our future operating expenses and capital expenditure\nrequirements; (xvi) our ability to retain the continued service of our key\npersonnel and to identify, and hire and retain additional qualified personnel;\n(xvii) the scope of protection we are able to establish and maintain for\nintellectual property rights, including our therapy platform, product\ncandidates, and research programs; (xviii) our ability to contract with\nthird-party suppliers and manufacturers and their ability to perform\nadequately; (xix) the pricing, coverage, and reimbursement of our product\ncandidates, if approved; and (xx) developments relating to our competitors and\nour industry, including competing product candidates and therapies.\nInformation regarding the foregoing and additional risks may be found in the\nsection entitled “Risk Factors” in documents that we file from time to\ntime with the Securities and Exchange Commission, which can be accessed\nat https://ir.renovorx.com/sec-filings.\n\nForward-looking statements included herein are made as of the date hereof, and\nRenovoRx does not undertake any obligation to update publicly such\nforward-looking statements to reflect subsequent events or circumstances,\nexcept as required by law.\n\nInvestor Contact:\nKCSA Strategic Communications\nValter Pinto or Jack Perkins\nT: 212-896-1254\nRenovoRx@KCSA.com\n\nMedia Contact:\nSTiR Communications\nHannah Williams\nT: 803-521-1214\nhannah@stir-communications.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/e18bf823-ff44-4bbd-82b9-3a311d58dad8)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX45Ks15","title":"RenovoRx Reports Record Second Quarter 2026 Results, Driven by Accelerating Commercial Adoption and 61% Sequential Quarterly Revenue Growth","author":"Globe Newswire","ticker":"RNXT","created":"2026-08-12T20:05:04.272Z","tickers":["RNXT"],"exchange":"NASDAQ","article_body":"Increases 2026 Annual Revenue Guidance to a Range of $3.75M to $4.25M\n\nFirst Treatment Delivered with RenovoCath(®) in Patient with Sarcoma in\nClinical Setting, Marking Expansion of Device to Other Solid Tumors\n\nPhase III TIGeR-PaC Trial Reaches Full Enrollment; Completion of Trial\nExpected in First Half 2027 with Topline Data Readout Expected in Second Half\n2027\n\nManagement to Host Conference Call Today at 4:30 p.m. ET\n\nMOUNTAIN VIEW, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- RenovoRx, Inc.\n(https://www.globenewswire.com/Tracker?data=joFnIP4Zr7pceNmPtBEPQ7hKbGV9bEMy_VYOqUhlzQ-4HTxXuN0dp_OHzQYGHoqTPPJzeg3aPt4u-uwwGMropg==)\n(“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life-sciences company\ndeveloping innovative targeted oncology therapies and commercializing\nRenovoCath(®), a patented, FDA-cleared drug-delivery device, today announced\nits financial results for the second quarter ended June 30, 2026, and provided\nshareholders with a business update highlighting continued commercial momentum\nand clinical progress.\n\n“In the second quarter of 2026, we delivered record revenue and executed on\nall three of the milestones we set for the business: revenue growth with\nanother record revenue quarter, commercial momentum evidenced by several\ncancer center activations, and expansion of the application of our technology\nbeyond locally advanced pancreatic cancer (LAPC),” said Shaun Bagai, Chief\nExecutive Officer of RenovoRx. “We generated quarterly revenue of $909,000,\nan increase of approximately 61% compared to the first quarter of 2026, and\napproximately 115% compared to the second quarter of 2025. Our strong first\nhalf performance gives us confidence that our second half revenue will exceed\nour original full year forecast. This outlook is driven by more active\ncommercial cancer center customers, more patients treated via procedures with\nRenovoCath, and repeat ordering across our existing customer base.”\n\nMr. Bagai continued, “We ended the second quarter with 21 active commercial\ncancer center customers, an increase of more than 30% from the 16 centers\nreported at the time of our first quarter earnings call, and expanded our\ntotal commercial pipeline to 63 centers, including 42 additional centers\nprogressing through evaluation, approval, and activation. We continue to see\nmeaningful repeat utilization across our existing customer base, and for the\nfirst time, a treating physician chose RenovoCath to deliver therapy to a\npatient with a solid tumor beyond pancreatic cancer, marking an important,\nphysician-driven expansion of the clinical application of our TAMP\nplatform.”\n\n“Looking ahead, we remain focused on executing against both our near-term\ncommercial priorities and our long-term clinical objectives,” added Mr.\nBagai. “Based on current trends, we expect third quarter revenue to surpass\nsecond-quarter revenue and set another record. We remain on track to meet or\nexceed our target of 36 active commercial cancer center customers by year end\n2026.\"\n\n\"The recently announced enrollment completion of our Phase III TIGeR-PaC trial\npositions the majority of our trial sites to also transition to commercial use\nin the second half of the year. Reflecting our strong first half performance,\nwe are raising and tightening the range for our full year revenue guidance. In\nshort, we believe RenovoRx is building a durable, capital-efficient commercial\nbusiness,\" said Mr. Bagai. \"Management believe that reaching a quarterly\nrevenue run-rate of approximately $5 million would position RenovoRx at\ncash-flow break-even, and based on our current trajectory, our internal plan\nanticipates achieving break-even operations in the fourth quarter of 2027.\"\n\nRenovoCath Commercialization Update\nRenovoRx delivered its strongest quarterly revenue performance to date.\nRevenue totaled $909,000 for the second quarter, an increase of approximately\n61% compared to the first quarter of 2026 and approximately 115% compared to\nthe second quarter of 2025. Second quarter revenue alone represented\napproximately 83% of the Company’s total revenue generated in all of 2025.\nFor the six months ended June 30, 2026, revenue totaled approximately $1.5\nmillion. This growth reflects continued expansion of active commercial cancer\ncenter customers and increasing procedural utilization of RenovoCath across\nthe Company’s growing base of commercial sites.\n\nThe Company’s commercial model is currently focused on activating new cancer\ncenter customers, which have been a source of recurring demand. RenovoRx ended\nthe second quarter of 2026 with 21 active commercial cancer center customers,\nan increase of more than 30% from the 16 active customers reported at the time\nof the Company’s first quarter 2026 earnings call. RenovoRx is also\nadvancing a customer pipeline of 42 additional centers in various stages of\nevaluation, approval, or activation. Combined with its 21 active customers,\nthis represents a total of 63 centers in the Company’s commercial funnel, a\n31% increase compared to the 48 total centers reported on its first quarter\ncall. The Company remains on pace to meet or exceed its target of 36 active\ncommercial cancer center customers by year end 2026. In addition, 15 Phase III\nTIGeR-PaC clinical trial sites are positioned to transition to commercial\nRenovoCath use, several of which have already begun doing so. These sites\nrepresent an anticipated and meaningful contributor to revenue in the second\nhalf of 2026.\n\nRenovoRx continues to observe strong repeat ordering from existing customers,\nwhich the Company views as one of the clearest indicators of physician\nsatisfaction and clinical utility in interventional oncology. As physicians\nincorporate RenovoCath into routine clinical practice, repeat utilization is\nexpected to drive sustained revenue growth. Based on its current customer\npipeline and trends to date, the Company expects third quarter 2026 revenue to\nexceed second quarter revenue which would represent another consecutive record\nrevenue quarter.\n\nSince receiving FDA 510(k) clearance, RenovoCath has been used in more than\n900 successful procedures. RenovoRx continues to estimate that the initial\ntotal addressable market (TAM) for RenovoCath as a stand-alone device could\ntranslate into an approximately $400 million peak annual U.S. sales\nopportunity for RenovoRx. Over time, as the Company expands the platform into\nadditional solid tumor indications, the Company believes it could unlock more\nthan $1 billion in peak annual sales potential.\n\nExpansion of RenovoCath Beyond Locally Advanced Pancreatic Cancer\nIn early August 2026, RenovoRx announced the first commercial clinical use of\nRenovoCath by an existing cancer center customer in the treatment of sarcoma,\nmarking the expansion of its targeted drug-delivery device to solid tumors\nbeyond pancreatic cancer. The case involved a physician who had previously\ntreated LAPC patients using RenovoCath and returned to RenovoRx with a plan to\nuse the catheter to treat sarcoma. The Company views this physician-driven\nadoption as a meaningful endorsement of RenovoCath’s potential as a\nstandalone device across additional difficult-to-treat solid tumors within its\nFDA-cleared fields of use.\n\nOngoing Phase III TIGeR-PaC Trial Update\nRecently, RenovoRx announced that it achieved full enrollment in its Phase III\nTIGeR-PaC trial evaluating intra-arterial delivery of intra-arterial\ngemcitabine (IAG) via the RenovoCath device for the treatment of LAPC. This\nsignificant milestone reflects successful patient recruitment, clinical\nexecution, and collaboration among investigators and study teams evaluating\nIAG for LAPC, a difficult-to-treat cancer. The primary endpoint of the study\nis overall survival. TIGeR-PaC is designed to evaluate whether RenovoRx’s\npatented method of targeted delivery of the chemotherapy gemcitabine improves\npatient survival, safety, and tolerability compared to the standard of care\n(systemic (intravenous) chemotherapy gemcitabine + Abraxane).\n\nAs of August 7, 2026, TIGeR-PaC trial investigators have been notified by\nRenovoRx that patient enrollment is closing. Completion of the trial is\nexpected during the first half of 2027, after 86 events (i.e., patient deaths)\nhave been observed. As of August 11, 2026, 78 events have occurred. Following\ncompletion of the trial, initial topline trial data is expected to be\navailable during the second half of 2027.\n\nWith enrollment complete, RenovoRx is now focused on advancing toward final\ndata analysis. These efforts build on the successful completion of the second\ninterim analysis in 2025, after which the independent Data Monitoring\nCommittee recommended continuation of the trial without modification. To\npreserve trial integrity, the Company elected to defer publication of interim\ndata until study completion.\n\nRenovoRx continues to view TIGeR-PaC as a critical long-term value driver,\nwhile emphasizing that its current commercial strategy is independent of the\ntrial’s ultimate outcome and timeline.\n\nSecond Quarter 2026 and Subsequent Key Highlights\nRenovoRx continued to execute on its dual commercial and clinical strategy\nduring the second quarter of 2026 and the subsequent period, building\nreal-world evidence base for its TAMP platform.\n\nDuring the second quarter of 2026, several scientific data updates supported\nthe use of intra-arterial gemcitabine delivery via TAMP in LAPC. A\npeer-reviewed case study by researchers at Moffitt Cancer Center, published in\nRadiology Case Reports, found that PET-CT imaging, rather than CT alone,\nshowed a meaningful reduction in tumor metabolic activity after treatment.\nThese findings suggest that PET imaging may help optimize monitoring of\ntherapeutic response following TAMP-delivered treatment.\n\nIn addition, the PK sub-study of the TIGeR-PaC trial has been accepted and\nwill be published in the near future in the Journal of Cancer Chemotherapy and\nPharmacology. The findings support TAMP as a targeted delivery method for\ngemcitabine, demonstrating its potential to increase local drug potency while\nreducing systemic exposure and common side effects.\n\nFinally, a peer-reviewed case series in Case Reports in Oncology from\nresearchers at Hackensack Meridian Health’s Jersey Shore University’s\nMedical Center was accepted and will be published in the near future. The case\nseries highlights their experience with the TAMP procedure in LAPC.\n\nThe ramping up of publication of the TAMP procedure by physicians, the Company\nbelieves is another sign of adoption as TAMP traverses from an experimental\nprocedure to becoming a potential standard of care.\n\nCash Resources, History of Losses and Planned Activities\nRenovoRx continued to build the evidence base for its TAMP platform through a\nmulti-center post-marketing registry study generating real-world safety and\nefficacy data, as well as investigator-initiated trials (IITs) in borderline\nresectable and metastatic pancreatic cancer designed to achieve cost\nneutrality while broadening the platform’s evidence base. In the second\nquarter of 2026, the Company began supporting a new IIT in cholangiocarcinoma\n(bile duct cancer).\n\nRenovoRx received FDA Orphan Drug Designation for oxaliplatin in the treatment\nof pancreatic cancer in the second quarter of 2026, further expanding the\npotential applications of its targeted drug-delivery platform.\n\nFinancial Highlights for the Second Quarter Ended June 30, 2026\n* Revenue for the three months ended June 30, 2026 was $909,000, compared to\n$422,000 for the three months ended June 30, 2025. The increase was driven by\nthe continued commercialization of RenovoCath and expanding adoption across\nU.S. cancer centers.\n* Gross profit for the three months ended June 30, 2026 was $766,000,\nrepresenting a gross margin of approximately 84%, consistent with the\napproximately 85% gross margin in the first quarter of 2026 and reflecting the\nunderlying economics of RenovoCath.\n* Research and development expenses were approximately $1.2 million for the\nthree months ended June 30, 2026, compared to approximately $1.4 million for\nthe three months ended June 30, 2025.\n* Selling, general, and administrative expenses were approximately $2.9\nmillion for the three months ended June 30, 2026, compared to approximately\n$1.5 million for the three months ended June 30, 2025, a reflection of the\nCompany’s continued execution on its commercial infrastructure strategy.\n* Net loss for the three months ended June 30, 2026, was approximately $2.9\nmillion, compared to approximately $2.9 million for the three months ended\nJune 30, 2025. Net loss per share was $0.06 for the three months ended June\n30, 2026, compared to a net loss of $0.08 for the three months ended June 30,\n2025.\n* Cash and cash equivalents were approximately $9.5 million as of June 30,\n2026, compared to approximately $12.4 million as of March 31, 2026. This\nevidences the disciplined deployment of capital raised in the Company’s\nMarch 2026 private placement. The Company believes its current cash resources\nare sufficient to fund operations into the second half of 2027.\n* Shares Outstanding: As of June 30, 2026, common shares outstanding totaled\n45,121,982.\n* Guidance: RenovoRx is raising and tightening the range of its full-year 2026\nrevenue guidance to a range of $3.75 million to $4.25 million, from its prior\nrange of $3.0 million to $4.0 million. The updated guidance implies\nyear-over-year revenue growth of approximately 241% to 286% compared to\nfull-year 2025 revenue of $1.1 million.\n Conference Call Details                                                                             \n Event:      RenovoRx Second Quarter 2026 Financial Results and Business Highlights Conference Call  \n Date:       Wednesday, August 12, 2026                                                              \n Time:       4:30 p.m. ET                                                                            \n Live Call:  1-877-407-4018 (U.S. Toll Free) or 1-201-689-8471 (International)                       \n Webcast:    https://ir.renovorx.com/news-events/ir-calendar-events                                  \n\nFor interested individuals unable to join the conference call, a link to the\nrecording will be available on RenovoRx’s Investor Relations website\n(https://www.globenewswire.com/Tracker?data=7yJm9dJrYUvDkaZk6SyiVxr0FDAfWQS3SRHKQMB50sDub0OT2B8DdCA6WMorKc5JL91TDx_DuzCq_ir_maBv7wDsTRSXex-Zd39X3msmmVY=),\nand a dial-in replay will be available until August 26, 2026, and can be\naccessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671\n(International) and entering replay pin number 13761368.\n\nA question and answer session will occur at the end of the call, and a link to\nthe recording of this presentation will be available on RenovoRx’s Investor\nRelations website\n(https://www.globenewswire.com/Tracker?data=7yJm9dJrYUvDkaZk6SyiVxr0FDAfWQS3SRHKQMB50sD7mR87-M0Gf1Sha2qZdzsxqr4oOruPLpAvSq2EvJ6xPEKnbY6qd4FMoQUKcxl3-bY=)\nafter the event.\n\n RENOVORX, INC.                                                                                                                                                         \n CONDENSED STATEMENTS OF OPERATIONS                                                                                                                                     \n (Unaudited)                                                                                                                                                            \n (Dollar in thousands, except per share amounts)                                                                                                                        \n                                                                Three Months Ended June 30,                         Six Months Ended June 30,                           \n                                                                       2026                      2025                      2026                      2025               \n Revenues                                                       $      909                $      422                $      1,472              $      619                \n Cost of revenues                                                      143                       152                       227                       246                \n Gross profit                                                   $      766                $      270                $      1,245              $      373                \n                                                                       84.3        %             64.0        %             84.6        %             60.3        %      \n Operating expenses:                                                                                                                                                    \n Research and development                                              1,200                     1,426                     2,428                     3,068              \n Selling, general and administrative                                   2,915                     1,522                     5,635                     3,093              \n Total operating expenses                                              4,115                     2,948                     8,063                     6,161              \n                                                                                                                                                                        \n Income/(loss) from operations                                         (3,349      )             (2,678      )             (6,818      )             (5,788      )      \n                                                                                                                                                                        \n Other income (expense), net:                                                                                                                                           \n Interest income, net                                                  90                        133                       134                       239                \n Loss on disposition of asset                                          (2          )             —                         (2          )             —                  \n Change in fair value of common warrant liability                      350                       (350        )             254                       234                \n Total other income (expense), net                                     438                       (217        )             386                       473                \n                                                                                                                                                                        \n Net loss                                                       $      (2,911      )      $      (2,895      )      $      (6,432      )      $      (5,315      )      \n Net loss per share                                                                                                                                                     \n Basic and diluted                                              $      (0.06       )      $      (0.08       )      $      (0.15       )      $      (0.16       )      \n Weighted-average shares used in computing net loss per share:                                                                                                          \n Basic and diluted                                                     47,298,148                36,576,567                42,690,881                34,000,539         \n\n\n\n RENOVORX, INC.                                                                                                                                                         \n RECONCILIATION OF GAAP NET INCOME/(LOSS)                                                                                                                               \n TO NON-GAAP NET INCOME                                                                                                                                                 \n (Unaudited)                                                                                                                                                            \n (Dollar in thousands, except per share amounts)                                                                                                                        \n                                                                Three Months Ended June 30,                         Six Months Ended June 30,                           \n                                                                       2026                      2025                      2026                      2025               \n GAAP net income                                                $      (2,911      )      $      (2,895      )      $      (6,432      )      $      (5,315      )      \n                                                                                                                                                                        \n Share-based compensation expense:                                                                                                                                      \n Research and development                                              216                       106                       327                       243                \n Selling, general and administrative                                   354                       239                       560                       390                \n Total share-based compensation expense                                570                       345                       887                       633                \n                                                                                                                                                                        \n Non-GAAP net income                                            $      (2,341      )      $      (2,550      )      $      (5,545      )      $      (4,682      )      \n                                                                                                                                                                        \n GAAP basic earnings per share                                  $      (0.06       )      $      (0.08       )      $      (0.15       )      $      (0.16       )      \n Effect of non-GAAP adjustments on basic earnings per share            0.01                      0.01                      0.02                      0.02               \n Non-GAAP basic earnings per share                              $      (0.05       )      $      (0.07       )      $      (0.13       )      $      (0.14       )      \n                                                                                                                                                                        \n Weighted-average shares used in computing net loss per share:                                                                                                          \n Basic and diluted                                                     47,298,148                36,576,567                42,690,881                34,000,539         \n\n\n\n RENOVORX, INC.                                                                             \n CONDENSED BALANCE SHEETS                                                                   \n (Unaudited)                                                                                \n (Dollar in thousands)                                                                      \n                                                    June 30,              December 31,      \n                                                    2026                  2025              \n                                                                                            \n Assets                                                                                     \n Current assets:                                                                            \n Cash and cash equivalents                          $    9,479         $  7,024             \n Accounts receivable, net                                480              139               \n Inventory                                               383              189               \n Prepaid expenses                                        315              324               \n Other current assets                                    153              217               \n Total current assets                                    10,810           7,893             \n                                                                                            \n Operating lease right-of-use asset                      368              190               \n Property and equipment, net                             94               12                \n Other non-current assets                                200              —                 \n Total assets                                       $    11,472        $  8,095             \n                                                                                            \n Liabilities and stockholders’ equity                                                       \n Current liabilities:                                                                       \n Accounts payable                                   $    866           $  799               \n Accrued expenses and other current liabilities          1,018            1,163             \n Total current liabilities                               1,884            1,962             \n                                                                                            \n Common stock warrant liability                          350              604               \n Operating lease liability, net of current portion       259              107               \n Total liabilities                                  $    2,493         $  2,673             \n                                                                                            \n Stockholders’ equity:                                                                      \n Common stock                                            5                4                 \n Additional paid-in capital                              76,793           66,805            \n Accumulated deficit                                     (67,819  )       (61,387  )        \n Total stockholders’ equity                              8,979            5,422             \n Total liabilities and stockholders’ equity         $    11,472        $  8,095             \n\nAbout RenovoCath\nBased on its FDA clearance, RenovoCath(®) is intended for the isolation of\nblood flow and delivery of fluids, including diagnostic and/or therapeutic\nagents, to select sites in the peripheral vascular system. RenovoCath is also\nindicated for temporary vessel occlusion in applications including\narteriography, preoperative occlusion, and chemotherapeutic drug infusion. For\nfurther information regarding our RenovoCath Instructions for Use (“IFU”),\nplease see:\nhttps://renovorx.com/wp-content/uploads/2026/06/IFU-10004-Rev.-H-Universal-IFU.pdf.\n\nAbout RenovoRx, Inc.\nRenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing\ninnovative targeted oncology therapies and commercializing RenovoCath(®), a\npatented, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery\ndevice, targeting high unmet medical needs. RenovoRx’s\npatented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is\ndesigned for targeted therapeutic delivery across the arterial wall near the\ntumor site to bathe the target tumor, while potentially minimizing a\ntherapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel\napproach to targeted treatment offers the potential for increased safety,\ntolerance, and improved efficacy, and its mission is to transform the lives of\ncancer patients by providing innovative solutions to enable targeted delivery\nof diagnostic and therapeutic agents.\n\nRenovoRx is actively commercializing its TAMP technology and FDA-cleared\nRenovoCath as a standalone device. For its first full year of commercial\nefforts in 2025, RenovoRx generated approximately $1.1 million in RenovoCath\nsales and a record $563,000 of sales in the first quarter of 2026. RenovoRx is\nactively working to expand the number of medical institutions initiating new\nRenovoCath orders, including esteemed, high-volume National Cancer\nInstitute-designated centers.\n\nRenovoRx is also evaluating its novel drug-device combination oncology product\ncandidate intra-arterial gemcitabine delivered via RenovoCath, (known as IAG)\nin the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center\nfor Drug Evaluation and Research (the drug division of the FDA) under a U.S.\ninvestigational new drug application that is regulated by the FDA’s 21 CFR\n312 pathway. IAG utilizes RenovoCath, which is FDA-cleared for temporary\nvessel occlusion in applications including arteriography, preoperative\nocclusion, and chemotherapeutic drug infusion. RenovoRx achieved full\nenrollment in the TIGeR-PaC trial in August 2026, with completion of trial\nexpected in first half 2027 and with topline data readout expected in second\nhalf 2027.\n\nThe IAG combination product candidate, enabled by the RenovoCath device, is\ncurrently under investigation and has not been approved for commercial sale.\nRenovoCath with gemcitabine received Orphan Drug Designation for pancreatic\ncancer and bile duct cancer, which provides seven years of market exclusivity\nupon new drug application approval by the FDA.\n\nFor more information, visit www.renovorx.com. Follow RenovoRx on Facebook\n(https://www.globenewswire.com/Tracker?data=lgbR4NmMA9iuCcOMOG5bwt9iQHceCDPxWQnwKoCfjhdxDHFR-123axd4vnSB2la0NtOuDDmwQzaW-jLM4Hdvwc0Hte8P-FtT59XjTkgJZqk=), LinkedIn\n(https://www.globenewswire.com/Tracker?data=6f0S4jT2EKpzF31mXe3E4fMjAFHf5Dpn2YU0PO7MRzGILwdMPd9myQY42d-oyEnpqCFuNIZWbimUWjofxExnZ-NKBcBFLF6jDmZkkpK1ZmYxnOScnEcISpdgdlqieAQr),\nand X\n(https://www.globenewswire.com/Tracker?data=MFQ9zInOCDj3vGbtVQsOblOBtZXxSP4XMez9b-OnrH5MAQa6nBHHFYDRQoLgkNbY0uwquM4aXqL2kPYFk67mfw==).\n\nNon-GAAP Financial Measures\nIn addition to reporting financial results in accordance with U.S. generally\naccepted accounting principles (“GAAP”), the operating results presented\nin the accompanying tables include certain non-GAAP financial measures that\nexclude the non-cash expense associated with share-based compensation.\n\nWe are providing such non-GAAP financial information in this press release,\nincluding non-GAAP operating expenses, net income (loss), and earnings (loss)\nper share, as a supplement to our consolidated financial statements prepared\nin accordance with GAAP which appear in this press release and in our\nQuarterly Report on Form 10-Q for the quarter ended June 30, 2026 as filed\nwith the U.S. Securities and Exchange Commission. Our management uses these\nnon-GAAP measures internally to analyze financial results, evaluate\noperational performance, and assess liquidity. We believe that both management\nand investors benefit from referring to these non-GAAP measures when assessing\nperformance and when planning, forecasting, and analyzing future periods.\n\nWe believe these non-GAAP measures also enhance investors’ understanding of\nkey financial metrics used in operational decision-making and are useful for\ncomparing our performance to that of other companies. However, readers are\ncautioned that non-GAAP results are presented for supplemental information\npurposes only and should not be considered a substitute for GAAP financial\ninformation. These measures may differ from similarly titled non-GAAP measures\npresented by other companies. Moreover, non-GAAP financial measures are not\nrequired to be uniformly applied and are not audited.\n\nCautionary Note Regarding Forward-Looking Statements\nThis press release and statements of the Company’s management and third\nparties made in connection therewith contain forward-looking statements within\nthe meaning of Section 27A of the Securities Act of 1933, and Section 21E of\nthe Securities Exchange Act of 1934, including but not limited to statements\nregarding (i) our clinical trials and studies (including expectations for full\nenrollment and data read out), (ii) the potential for our product candidates\nto treat or provide clinically meaningful outcomes for certain medical\nconditions or diseases, and (iii) our efforts to commercialize our RenovoCath\nand TAMP technology for use in treating pancreatic and other solid tumor\ncancers, and our expected financial results from such efforts, including our\nestimates for 2026 annual revenue. Statements that are not purely historical\nare forward-looking statements. The forward-looking statements contained\nherein are based upon our current expectations and beliefs regarding future\nevents, many of which, by their nature, are inherently uncertain, outside of\nour control, and involve assumptions that may never materialize or may prove\nto be incorrect. These may include estimates, projections, and statements\nrelating to our research and development plans, commercial and other business\nplans, intellectual property development, clinical trials, our therapy\nplatform, financing plans, objectives, and expected operating results, all of\nwhich are based on current expectations and assumptions that are subject to\nsignificant known and unknown risks and uncertainties that may cause actual\nresults to differ materially and adversely from those expressed or implied by\nthese forward-looking statements. These statements may be identified using\nwords such as “may,” “expects,” “plans,” “aims,”\n“anticipates,” “believes,” “forecasts,” “aim,” “goal,”\n“estimates,” “intends,” and “potential,” or derivatives of these\nterms or other comparable terminology regarding RenovoRx’s statements about\nthe future, although not all forward-looking statements contain these words.\nThese forward-looking statements are subject to a number of risks,\nuncertainties and assumptions, that could cause actual events to differ\nmaterially from those projected or indicated by such statements, including,\namong other things: (i) the risk that our commercial efforts our TAMP\ntechnology (enabled by RenovoCath) may not lead to the achievement of our\nrevenue forecasts or to viable, revenue generating operations in general; (ii)\ncircumstances which would adversely impact our ability to efficiently utilize\nour cash resources on hand or raise additional funding; (iii) the timing of\nthe initiation, progress, completion and potential results (including the\nresults of interim analyses) of our preclinical studies, clinical trials, and\nour research programs (notably with respect to our TIGeR-PaC trial); (iv) the\npossibility that interim results may not be predictive of the outcome of our\nclinical trials, which may not demonstrate sufficient safety and efficacy to\nsupport regulatory approval of our product candidate; (v) that applicable\nregulatory authorities may disagree with our interpretation of the data,\nresearch, and clinical development plans and timelines, and the regulatory\nprocess for our product candidates; (vi) future potential regulatory\nmilestones for our product candidates, including those related to current and\nplanned clinical studies; (vii) our ability to use and expand our therapy\nplatform to build a pipeline of product candidates; (viii) our ability to\nadvance product candidates into, and successfully complete, clinical trials;\n(ix) the timing or likelihood of regulatory filings and approvals; (x) our\nestimates of the number of patients who suffer from the diseases we are\ntargeting and the number of patients that may enroll in our clinical trials;\n(xi) the commercialization potential of our product candidates, if approved;\n(xii) our ability and the potential to successfully manufacture and supply our\nproduct candidates for clinical trials and for commercial use, if approved;\n(xiii) future strategic arrangements and/or collaborations and the potential\nbenefits of such arrangements; (xiv) our estimates regarding expenses, future\nrevenue, capital requirements, needs for additional financing, our ability to\nobtain additional capital and our ability to maintain the listing of our\ncommon stock on Nasdaq; (xv) the sufficiency of our existing cash and cash\nequivalents to fund our future operating expenses and capital expenditure\nrequirements; (xvi) our ability to retain the continued service of our key\npersonnel and to identify, and hire and retain additional qualified personnel;\n(xvii) the scope of protection we are able to establish and maintain for\nintellectual property rights, including our therapy platform, product\ncandidates, and research programs; (xviii) our ability to contract with\nthird-party suppliers and manufacturers and their ability to perform\nadequately; (xix) the pricing, coverage, and reimbursement of our product\ncandidates, if approved; and (xx) developments relating to our competitors and\nour industry, including competing product candidates and therapies.\nInformation regarding the foregoing and additional risks may be found in the\nsection entitled “Risk Factors” in documents that we file from time to\ntime with the Securities and Exchange Commission, which can be accessed\nat https://ir.renovorx.com/sec-filings.\n\nForward-looking statements included herein are made as of the date hereof, and\nRenovoRx does not undertake any obligation to update publicly such\nforward-looking statements to reflect subsequent events or circumstances,\nexcept as required by law.\n\nInvestor Contact:\nKCSA Strategic Communications\nValter Pinto or Jack Perkins\nT: 212-896-1254\nRenovoRx@KCSA.com\n\nMedia Contact:\nSTiR Communications\nHannah Williams\nT: 803-521-1214\nhannah@stir-communications.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/e18bf823-ff44-4bbd-82b9-3a311d58dad8)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-08-12T20:05:04.32180177Z","server_sent_at_ms":1786565104321},"received_at":"2026-08-12T20:05:04.376Z","source_url":"https://www.globenewswire.com/news-release/2026/08/12/3344073/0/en/renovorx-reports-record-second-quarter-2026-results-driven-by-accelerating-commercial-adoption-and-61-sequential-quarterly-revenue-growth.html"},"analysis":{"id":"106225","press_release_id":"117229","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":["Cash runway extends only into the second half of 2027, likely requiring future financing.","Company remains unprofitable with a net loss of approximately $2.9 million in Q2."],"eventType":"earnings","narrative":"RenovoRx reported Q2 revenue of $909,000, an increase of 61% sequentially and 115% year-over-year, driven by growing adoption of the RenovoCath device. Based on the strong first-half performance, the company raised its full-year 2026 revenue guidance to a range of $3.75 million to $4.25 million, up from the prior range of $3.0 million to $4.0 million.\n\nOperationally, the company expanded its active commercial cancer center customers to 21, a 30% increase from the prior quarter, and marked the first use of RenovoCath in a sarcoma patient. In a significant clinical milestone, the Phase III TIGeR-PaC trial reached full enrollment, with topline data expected in the second half of 2027.\n\nFinancially, RenovoRx maintained a healthy gross margin of 84% and held $9.5 million in cash as of June 30, 2026. Management stated that current resources are sufficient to fund operations into the second half of 2027 and anticipates reaching cash-flow break-even in the fourth quarter of 2027.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Beat-and-raise quarter with 61% sequential growth and pivotal Phase III trial enrollment complete."},"keyFigures":{"revenue":909000,"guidance":"FY2026 revenue $3.75M to $4.25M, raised from $3.0M to $4.0M","revenueYoy":"115%","customDimensions":{"cash":9500000,"net_loss":2900000,"gross_margin":"84%","active_centers":21}},"quotedText":"We generated quarterly revenue of $909,000, an increase of approximately 61% compared to the first quarter of 2026, and approximately 115% compared to the second quarter of 2025.","namedEntities":{"people":[{"name":"Shaun Bagai","role":"Chief Executive Officer"}],"products":["RenovoCath","TAMP","IAG","TIGeR-PaC"],"companies":[{"name":"RenovoRx, Inc.","ticker":"RNXT"},{"name":"Moffitt Cancer Center"},{"name":"Hackensack Meridian Health’s Jersey Shore University’s Medical Center"}],"dollarAmounts":[{"amount":"$909,000","context":"Q2 2026 revenue"},{"amount":"$3.75 million to $4.25 million","context":"FY 2026 revenue guidance"},{"amount":"$9.5 million","context":"cash and cash equivalents as of June 30, 2026"},{"amount":"$2.9 million","context":"Q2 2026 net loss"}]},"materialImpact":{"score":4,"reasoning":"The company reported a strong beat with 61% sequential revenue growth and 115% year-over-year growth, coupled with a significant guidance raise. Additionally, the completion of enrollment in the pivotal Phase III TIGeR-PaC trial is a major derisking milestone."},"tickerRelevance":{"others":[],"primary":"RNXT"},"globalImportance":25,"audienceRelevance":30,"eventTypeSecondary":["guidance_update","clinical_trial"],"importanceComponents":{"tickerTier":"micro-cap","eventGravity":"earnings_beat_and_raise","sectorWeight":"biotech"}},"event_type":"earnings","event_type_secondary":["guidance_update","clinical_trial"],"sentiment":"bullish","material_impact_score":4,"narrative":"RenovoRx reported Q2 revenue of $909,000, an increase of 61% sequentially and 115% year-over-year, driven by growing adoption of the RenovoCath device. Based on the strong first-half performance, the company raised its full-year 2026 revenue guidance to a range of $3.75 million to $4.25 million, up from the prior range of $3.0 million to $4.0 million.\n\nOperationally, the company expanded its active commercial cancer center customers to 21, a 30% increase from the prior quarter, and marked the first use of RenovoCath in a sarcoma patient. In a significant clinical milestone, the Phase III TIGeR-PaC trial reached full enrollment, with topline data expected in the second half of 2027.\n\nFinancially, RenovoRx maintained a healthy gross margin of 84% and held $9.5 million in cash as of June 30, 2026. Management stated that current resources are sufficient to fund operations into the second half of 2027 and anticipates reaching cash-flow break-even in the fourth quarter of 2027.","key_figures":{"revenue":909000,"guidance":"FY2026 revenue $3.75M to $4.25M, raised from $3.0M to $4.0M","revenueYoy":"115%","customDimensions":{"cash":9500000,"net_loss":2900000,"gross_margin":"84%","active_centers":21}},"named_entities":{"people":[{"name":"Shaun Bagai","role":"Chief Executive Officer"}],"products":["RenovoCath","TAMP","IAG","TIGeR-PaC"],"companies":[{"name":"RenovoRx, Inc.","ticker":"RNXT"},{"name":"Moffitt Cancer Center"},{"name":"Hackensack Meridian Health’s Jersey Shore University’s Medical Center"}],"dollarAmounts":[{"amount":"$909,000","context":"Q2 2026 revenue"},{"amount":"$3.75 million to $4.25 million","context":"FY 2026 revenue guidance"},{"amount":"$9.5 million","context":"cash and cash equivalents as of June 30, 2026"},{"amount":"$2.9 million","context":"Q2 2026 net loss"}]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-08-12T21:21:54.220Z","global_importance":25,"audience_relevance":30,"importance_components":{"tickerTier":"micro-cap","eventGravity":"earnings_beat_and_raise","sectorWeight":"biotech"}},"durationMs":336528,"modelName":"glm-4.7"}}