RenovoGem (gemcitabine with RenovoCath) / RenovoRx - LARVOL DELTA

Intra-arterial gemcitabine versus intravenous gemcitabine: Pharmacokinetic and pharmacodynamic sub-study of the TIGeR-PaC phase 3 clinical trial. (ASCO-GI 2026) - P3 | "In this analysis, localized, dual-balloon catheter-mediated IAG resulted in decreased systemic levels of gemcitabine compared to IVG, along with increased levels of its inactive metabolite dF/dU. Thus, in addition to providing increased local potency, the IAG approach, in which gemcitabine is rapidly converted to its inactive metabolite, may also be beneficial in decreasing gemcitabine-related systemic side effects. Clinical trial information: NCT03257033."

Clinical • P3 data • PK/PD data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • CA 19-9

RenovoRx Highlights Peer-Reviewed Publication of Pharmacokinetic and Pharmacodynamic (PK/PD) Data Supporting TAMP Platform’s Targeted Drug-Delivery in Locally Advanced Pancreatic Cancer (GlobeNewswire) - "The data shows that TAMP (Trans-Arterial Micro-Perfusion)-mediated delivery concentrated chemotherapy at the tumor site, extracting roughly 51% of the drug locally before it entered the bloodstream, meaningfully lowering systemic exposure in a way that could reduce systemic side effects. In addition, a statistically significant correlation between the drug's local metabolism and a drop in the CA 19-9 tumor marker provided an early indication of improved drug penetration into the tumor area and potential tumor response with intra-arterial delivery....RenovoRx also recently announced the closing of enrollment of the TIGeR-PaC trial, with trial completion expected in the first half of 2027 and expected initial top line data availability in the second half of 2027."

P3 data: top line • PK/PD data • Trial completion date • Pancreatic Cancer

RenovoRx, Inc…is pleased to announce completion of enrollment in the Company’s Phase III TIGeR-PaC trial in locally advanced pancreatic cancer (LAPC). (Renovo Press Release) - "Completion of the trial is expected during the first half of 2027, after 86 events (i.e., patient deaths) have been observed. As of August 11, 2026, 78 events have occurred. Following completion of the trial, initial top line trial data is expected to be available during the second half of 2027."

Enrollment closed • P3 data: top line • Trial completion date • Pancreatic Cancer

TIGeR-PaC: Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC (clinicaltrials.gov) - P3 | N=190 | Recruiting | Sponsor: RenovoRx | Trial completion date: Sep 2026 ➔ Sep 2027 | Trial primary completion date: Jun 2026 ➔ Jun 2027

Trial completion date • Trial primary completion date • Neutropenia • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Pharmacokinetic and pharmacodynamic sub-study of trans-arterial vs. intravenous gemcitabine in the TIGeR-PaC phase 3 clinical trial. (PubMed, Cancer Chemother Pharmacol) - P3 | "In addition to providing increased local potency, localized IAG, in which gemcitabine is rapidly converted to its inactive metabolite dFdU, may also be beneficial in decreasing gemcitabine-related systemic side effects."

Clinical • Journal • P3 data • PK/PD data • Oncology • Solid Tumor

RenovoRx Receives Notice of Allowance for New U.S. Patent Covering RenovoCath, an Advanced Dual-Occlusion Catheter, for Targeted Therapeutic Drug-Delivery for Cancer Treatment (The Manila Times) - "...Company’s patent application (U.S. Application No. 18/184,620)...The newly allowed application further strengthens RenovoRx’s expanding intellectual property portfolio and provides additional patent protection for RenovoCath, an advanced dual-occlusion catheter, designed to deliver cancer therapies directly to targeted tumor sites...The claims allowed cover RenovoCath’s proprietary catheter system, which includes a primary catheter, multiple ports, and expandable occlusion balloons that seal a segment of a blood vessel to create a controlled treatment zone. A secondary catheter can be advanced through the primary catheter into a branching vessel, allowing highly selective access to adjacent vasculature....RenovoRx anticipates full enrollment in the TIGeR-PaC trial in the very near term and final data readout in mid to late 2027."

P3 data • Patent • Pancreatic Cancer

RenovoRx, Inc….announced that it will host its second quarter 2026 financial results and business highlights conference call on August 12, 2026, at 4:30 p.m. ET. (The Manila Times) - "Management will also provide an update on the Phase III TIGeR-PaC clinical trial evaluating intra-arterial gemcitabine delivered via RenovoCath in locally advanced pancreatic cancer, with full enrollment in the trial expected in the very near future and final data anticipated in mid-to-late 2027."

P3 data • Trial status • Pancreatic Cancer

The TIGeR-PaC phase 3 clinical trial examining intra-arterial gemcitabine versus intravenous gemcitabine: Pharmacokinetic and pharmacodynamic sub-study. (ASCO 2026) - P3 | "In this analysis, localized IAG resulted in decreased systemic levels of gemcitabine compared to IVG, along with increased levels of its inactive metabolite dFdU. Thus, in addition to providing increased local potency, the IAG approach, in which gemcitabine is rapidly converted to its inactive metabolite, may be beneficial in decreasing gemcitabine-related systemic side effects. Clinical trial information: NCT03257033."

Clinical • P3 data • PK/PD data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

RenovoRx's TIGeR-PaC Phase III clinical trial evaluating IAG in LAPC continues to advance, with the Company anticipating notification of enrollment closure in June 2026 and final data readout in mid to late 2027. (GlobeNewswire)

Enrollment status • P3 data • Pancreatic Cancer

Trans-arterial gemcitabine micro perfusion of locally advanced pancreatic cancer enabled by coil plus glue embolization of a pancreaticoduodenal branch. (PubMed, Radiol Case Rep) - "Complete occlusion of the PDA branch was achieved with coil plus glue embolization; TAMP-mediated gemcitabine delivery was then successfully performed in the same setting. In cases where arterial anatomy may otherwise preclude TAMP, coil plus glue embolization of side branches may provide a viable solution."

Journal • Oncology • Pancreatic Cancer • Solid Tumor

RenovoRx Announces Pharmacokinetic and Pharmacodynamic Data Abstract Supporting the TAMP™ Therapy Platform Accepted for Presentation at the 2026 ASCO Annual Meeting (GlobeNewswire) - "Accepted Abstract is a Sub-Study in RenovoRx’s Ongoing Phase III TIGeR-PaC Clinical Trial and Explores the TAMP Therapy Platform’s Potential to Increase Local Drug Potency and Reduce Systemic Exposure and Common Side Effects of Chemotherapy...Additionally, the abstract studies IAG administration and its direct correlation between the metabolite levels and CA 19-9, a biomarker commonly used to assess potential chemotherapy response."

P3 data • PK/PD data • Pancreatic Cancer

RenovoRx Announces Key Phase III Milestone: TIGeR-PaC Trial Surpasses 100 Randomized Patients as Study Nears Completion of Enrollment (Renovo Press Release) - "TIGeR-PaC Trial Enrollment Remains on Track for Completion in First Half of 2026, with Final Data Expected in 2027....The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of March 24, 2026, 104 patients have been randomized and 72 events have occurred."

P3 data • Trial status • Pancreatic Cancer

PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP) (clinicaltrials.gov) - P1/2 | N=10 | Not yet recruiting | Sponsor: University of Vermont

New P1/2 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

RenovoRx to Participate in Fireside Chat at A.G.P. Virtual Healthcare Company Showcase on May 21st (Businesswire) - "Mr. Bagai will share recent business developments, highlighting continuing momentum with the Company’s RenovoCath commercialization, as well as progress in the ongoing Phase III TIGeR-PaC clinical trial. TIGeR-PaC is evaluating RenovoRx’s novel drug-device combination oncology product candidate (intra-arterial gemcitabine, known as IAG) for treatment in locally advanced pancreatic cancer (LAPC), which is currently under investigation, and has not yet been approved for commercial sale."

Commercial • Trial status • Pancreatic Cancer

Johns Hopkins Medicine Initiates Patient Enrollment for RenovoRx’s Ongoing Phase III TIGeR-PaC Clinical Trial (Businesswire) - "RenovoRx, Inc...announced that Johns Hopkins Medicine is now initiated to enroll patients with locally advanced pancreatic cancer (LAPC) in RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial. Johns Hopkins Medicine becomes the newest addition to a distinguished network of clinical cancer sites across the United States participating in this important trial...The initiation of patient enrollment at Johns Hopkins Medicine will be at their Sibley Memorial Hospital campus and marks the most recent site to support RenovoRx’s path to completing patient enrollment for the trial. RenovoRx is expecting to achieve full enrollment in the TIGeR-PaC trial during 2025....RenovoRx currently anticipates the 52nd event to occur during the second quarter of 2025. The key recommendation from the Data Monitoring Committee on whether or not to continue the study based on the data reviewed is expected to be announced in the second half of 2025."

DSMB • Enrollment status • Pancreatic Cancer

RenovoRx Highlights New Human Pharmacokinetic Data Abstract at SSO 2025 Annual Meeting (Businesswire) - P3 | N=190 | TIGeR-PaC (NCT03257033) | Sponsor: RenovoRx | "PK analyses were performed on 19 patients with locally advanced pancreatic cancer receiving IAG from six sites as part of the TIGeR-PaC trial. In this analysis, localized, dual-balloon catheter-mediated IAG resulted in lower systemic levels compared to intravenous delivery of gemcitabine. As such, the study found that IAG may be beneficial in decreasing chemotherapy-related systemic side effects. Correlative patient reported outcomes in patients receiving IAG supports this approach as an alternative for LAPC patients who are having difficulty tolerating more traditional systemic regimens."

P3 data • Pancreatic Cancer

RenovoRx Announces Closing of $12.1 Million Underwritten Public Offering of Common Stock (Businesswire) - "RenovoRx, Inc...announced the closing of its previously announced $12.1 million firm commitment underwritten public offering of common stock led by multiple fundamental healthcare institutional investors....In the offering, which closed on February 10, 2025, RenovoRx sold 11,523,810 shares of its common stock at an offering price of $1.05 per share. The gross proceeds from the offering were approximately $12.1 million, with net proceeds of approximately $10.9 million after deducting underwriting discounts and commissions and offering expenses payable by RenovoRx. RenovoRx intends to use the net proceeds from the offering for working capital and general corporate purposes, including continued progress on its Phase III TIGeR-PaC study..."

Financing • Pancreatic Cancer

RenovoRx Highlights Promising Pre-Clinical Data Abstract: TAMP Therapy Platform Offers Potential to Improve Localized and Targeted Drug Delivery (Businesswire) - "The results of the study support a more optimized drug delivery method for tumors that suffer from limited blood supply and poor drug penetration. The TAMP technique was evaluated in a porcine (pig) model utilizing micro-CT imaging for precise monitoring of drug penetration into tissue....The data shows that, by using RenovoCath, researchers were able to isolate sections of the blood vessel through the adjustment of the distance between the occlusion balloons, thereby excluding any off-target side branches. Researchers were able to confirm the level of penetration into the targeted area utilizing micro-CT imaging. The penetration achieved appears to be consistent with a more optimized drug delivery. The observed effect is expected to be even stronger if radiation is applied beforehand."

Preclinical • Pancreatic Adenocarcinoma

About the TIGeR-PaC Clinical Trial (Businesswire) - "The second interim analysis for this study will be triggered by the 52^nd event (i.e., patient death), which is estimated to occur in early 2025. The second interim data readout is anticipated to occur by the end of the first half of 2025, with the timing for such readout, however, being dependent on customary factors such as time needed for analysis. RenovoRx is also aiming to complete patient enrollment in the TIGeR-PaC study in the first half of 2025."

Enrollment status • P3 data • Pancreatic Cancer

Intra-arterial gemcitabine versus intravenous gemcitabine: Pharmacokinetic sub-study of the TIGeR-PaC phase 3 clinical trial. (ASCO-GI 2025) - P3 | "In this analysis, localized, dual-balloon catheter-mediated IAG resulted in decreased systemic levels of gemcitabine compared to IVG. Thus, in addition to providing increased local potency, the IAG approach may also be beneficial in decreasing gemcitabine-related systemic side effects. 1."

Clinical • P3 data • PK/PD data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

RenovoRx Highlights Promising Pharmacokinetic Data Abstract Presented at ASCO GI 2025 (Businesswire) - P3 | N=190 | TIGeR-PaC (NCT03257033) | Sponsor: RenovoRx | "Dr. Novelli, together with her co-authors, presented...a sub-study of RenovoRx’s ongoing pivotal Phase III TIGeR-PaC clinical trial in LAPC. In this sub-study, PK analyses were performed on a sample of participants across TIGeR-PaC study clinical sites. These analyses compared treatment with intra-arterial gemcitabine (IAG), using the RenovoCath delivery system via TAMP, versus systemic intravenous gemcitabine, which is the current standard of care for patients with LAPC....Results of the sub-study showed RenovoRx’s IAG approach to drug delivery via TAMP decreased systemic levels of gemcitabine versus standard of care. In addition to providing increased local drug potency, the IAG approach may also be beneficial to decreasing gemcitabine-related systemic side effects."

P3 data • PK/PD data • Pancreatic Cancer

RenovoRx Continues to Grow Intellectual Property Portfolio for its Novel Drug-Delivery Therapy Platform (Businesswire) - "RenovoRx, Inc...highlighted its strong intellectual property (IP) position as it moves forward with commercial plans and clinical trial advancement in 2025, utilizing its novel Trans-Arterial Micro-Perfusion (TAMP) therapy platform...The new published international patent application WO2024102497 describes methods and tools for delivering treatments (including antibodies, nanoparticles, or charged molecules) directly to specific tissues....RenovoRx’s pivotal ongoing Phase III TIGeR-PaC clinical trial is evaluating its first product candidate, a novel investigational oncology drug-device combination utilizing the FDA-cleared RenovoCath device via TAMP for the intra-arterial administration of the chemotherapy gemcitabine. RenovoRx currently anticipates completion of both patient enrollment and the second interim analysis for TIGeR-PaC by the end of the first half of 2025."

Patent • Trial status • Pancreatic Cancer

RenovoRx Reports Third Quarter 2024 Financial Results and Operational Highlights (GlobeNewswire) - "Notably, RenovoRx signed a new work order with its manufacturing partner Medical Murray to increase production of RenovoCath devices. With manufacturing arrangements in place, RenovoRx is presently considering its best course for RenovoCath marketing and sales activities, which could be done directly or via a commercial partner....RenovoRx expects its RenovoCath commercial strategy to potentially generate revenue in 2025."

Commercial • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

RenovoRx Announces Presentation at Symposium on Clinical Interventional Oncology Highlighting TAMP for Targeted Treatment of Locally Advanced Pancreatic Cancer (GlobeNewswire) - "RenovoRx....announced that Ripal Gandhi...will present at the Symposium on Clinical Interventional Oncology...which is being held September 20-22, 2024, at the Loews Hotel in Miami Beach, Florida. Dr. Gandhi’s presentation will highlight RenovoRx’s TAMP...therapy platform for the treatment of locally advanced pancreatic cancer ('LAPC') and recent publications of clinical data...Dr. Gandhi’s presentation will provide an overview of the clinical challenges of the standard of care treatment available to LAPC patients....Dr. Gandhi will also discuss the status of the Company’s ongoing Phase III TIGeR-PaC study, which is evaluating the use of the TAMP therapy platform with gemcitabine HCl in patients with LAPC. Additionally, he will review...journal, The Oncologist, of early-stage clinical data on the intra-arterial administration of gemcitabine HCl utilizing the TAMP including Phase I/II dose escalation safety study (RR1) and acquired data from...observational registry study (RR2)."

Clinical • Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

RenovoRx CEO Shaun Bagai to Present at H.C. Wainwright’s 26th Annual Global Investment Conference on September 9, 2024 in New York (GlobeNewswire) - "RenovoRx, Inc...announced that Shaun Bagai, Chief Executive Officer, will present at H.C. Wainwright’s 26th Annual Global Investment Conference being held at the Lotte New York Palace Hotel in New York City. The conference will be held September 9-11, 2024, with Mr. Bagai’s presentation on September 9, 2024, at 7:00 a.m. ET. Mr. Bagai will discuss recent corporate achievements including progress on RenovoRx’s pivotal ongoing Phase III TIGeR-PaC clinical trial evaluating the proprietary TAMP (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of Locally Advanced Pancreatic Cancer (LAPC.)."

P3 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor