RenovoGem (gemcitabine with RenovoCath) / RenovoRx - LARVOL DELTA

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

RenovoRx Announces First Patient Enrolled at University of Nebraska Medical Center for the Ongoing Pivotal Phase III TIGeR-PaC Clinical Trial (GlobeNewswire) - "RenovoRx, Inc...announced today that the first patient has been enrolled at the University of Nebraska Medical Center ('UNMC') in RenovoRx’s ongoing pivotal Phase III TIGeR-PaC clinical trial for Locally Advanced Pancreatic Cancer (LAPC)....The second interim analysis for this study will be triggered by the 52nd event, which is estimated to occur in late 2024."

P3 data • Trial status • Gastrointestinal Cancer • Pancreatic Cancer • Solid Tumor

TIGeR-PaC: Intra-arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC (clinicaltrials.gov) - P3 | N=190 | Recruiting | Sponsor: RenovoRx | N=320 ➔ 190 | Trial completion date: Sep 2023 ➔ Sep 2026 | Trial primary completion date: Sep 2022 ➔ Jun 2026

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

University of Nebraska Medical Center Launches Patient Enrollment for RenovoRx’s Pivotal Phase III TIGeR-PaC Clinical Trial (GlobeNewswire) - "RenovoRx, Inc...announced today that the University of Nebraska Medical Center (UNMC) is now enrolling patients with Locally Advanced Pancreatic Cancer (LAPC) in the Company’s ongoing pivotal Phase III TIGeR-PaC clinical trial."

Enrollment status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

RenovoRx Highlights Recent Presentation of Clinical Data Abstract at the 2024 Society of Interventional Radiology Annual Scientific Meeting (Businesswire) - P3 | N=320 | TIGeR-PaC (NCT03257033) | Sponsor: RenovoRx | "RenovoRx, Inc...highlights a presentation of a clinical data abstract at the recent 2024 Society of Interventional Radiology (SIR) Annual Scientific Meeting, held March 23-27, 2024 in Salt Lake City, Utah. Clinical data was presented by David Sperling, MD, Associate Professor of Radiology at Columbia University Irving Medical Center in New York....The data presentation highlighted that of the 25 patients randomized to the TAMP therapy, 6 failed to complete all 8 planned procedures due to thrombosis of the targeted arterial artery. Among those 6 patients, the prevalence of MVT on the baseline abdominal CT imaging was 100%."

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

RenovoRx Closes $11.1 Million Private Placement, Providing Cash Runway into 2026 (Businesswire) - "RenovoRx, Inc...announced the closing of its previously announced private placement of approximately $11.1 million in gross proceeds....'Our April and January 2024 private placements, in which we raised $17.2 million in total gross proceeds, strengthen our balance sheet and energize our drive towards knowable value creation events over the next two years. These include: first, the continuation of our pivotal Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer towards a second interim readout and ultimate completion; second, the expansion of our TAMPclinical development pipeline into additional cancer indications; and third, our ongoing exploration of new commercial business development opportunities with our therapeutic technologies'."

Financing • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

RenovoRx Announces $11.1 Million at Market Private Placement (Businesswire) - "RenovoRx, Inc...announced the execution of definitive subscription agreements with accredited investors for a private placement which is expected to result in gross proceeds of approximately $11.1 million to RenovoRx, before deducting offering expenses. The proceeds from this financing, in addition to RenovoRx’s previously announced private placement on January 29, 2024 for gross proceeds of approximately $6.1 million, extend the Company’s cash runway into 2026. The financing allows RenovoRx to advance its lead program, the pivotal Phase III TIGeR-PaC clinical trial in locally advanced pancreatic cancer (LAPC), through the second interim readout and towards completion of the trial....Proceeds from the financing are also expected to enable the expansion of the TAMP clinical development pipeline into additional cancer indications."

Financing • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

RenovoRx Closes $6.1 Million Private Placement (Businesswire) - "RenovoRx, Inc...today announced that it has closed a private placement...resulting in gross proceeds of approximately $6.1 million, before deducting offering expenses...The closing of this private placement extends RenovoRx’s cash runway as RenovoRx continues its ongoing pivotal TIGeR-PaC Phase III clinical trial, with a second interim analysis for this study to occur at the 52^nd event (death), which is expected in late 2024....The financing will also allow RenovoRx to begin to engage additional clinical trial sites in preparation for the Company’s Phase III CouGar study in bile duct cancer, which is the second late-stage clinical trial to evaluate RenovoGem in a difficult-to-access solid tumor cancer."

Diagnostic • Financing • P3 data • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

RenovoRx to Present at the ROTH MKM Healthcare Opportunities Conference on October 12, 2023 (Businesswire) - "RenovoRx, Inc...announced that CEO, Shaun Bagai, will present at the ROTH MKM Healthcare Opportunities Conference in New York on October 12, 2023....Moderated by Scott Henry, Managing Director, Senior Research Analyst & Head of Pharmaceuticals Research at ROTH Capital Partners, LLC, will conduct a fireside chat with Mr. Bagai, who will discuss recent Company milestones, including the research collaboration with Imugene...and highlights from RenovoRx’s open label pivotal Phase III TIGeR- PaC study."

P3 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

RenovoRx Reports Second Quarter 2023 Financial Results and Operational Highlights (Businesswire) - "RenovoRx, Inc...today announced financial results for the second quarter ended June 30, 2023...'We are also excited for the upcoming year, when we expect our secondary interim analysis data readout.'...Initiated patient enrollment at the University of Texas Southwestern Medical Center for pivotal Phase III TIGeR-PaC clinical trial."

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

RenovoRx to Present at the 43rd Annual Canaccord Genuity Growth Conference (Businesswire) - P3 | N=320 | TIGeR-PaC (NCT03257033) | Sponsor: RenovoRx | "RenovoRx, Inc...announced that its CEO Shaun Bagai will provide a corporate overview and update at the 43rd Annual Canaccord Genuity Growth Conference on Thursday, August 10, 2023 at 10:30 AM ET in Boston, MA....Mr. Bagai will discuss recent Company milestones, including the research collaboration with Imugene...and highlights from RenovoRx’s open label pivotal Phase III TIGeR-PaC study....Interim data demonstrates a 6-month overall survival benefit, 8-month delay in cancer progression, and 65% reduction in adverse effects over systemic (intravenous) chemotherapy. The data, presented at the recent 2023 ESMO World Congress on Gastrointestinal Cancer, drove the decision from the TIGeR-PaC Data Monitoring Committee (DMC) to continue this pivotal trial."

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

RenovoRx Announces New Positive Interim Phase III Data Demonstrating RenovoGem Delays Cancer Progression by Eight Months in Locally Advanced Pancreatic Cancer (Businesswire) - P3 | N=320 | TIGeR-PaC (NCT03257033) | Sponsor: RenovoRx | "RenovoRx, Inc...today presented new positive data on progression-free survival (PFS) from the pivotal Phase III open label TIGeR-PaC study of RenovoGem (intra-arterial administration of gemcitabine) in locally advanced pancreatic cancer (LAPC)....The interim analysis demonstrated an eight-month median PFS benefit, 15 versus 7 months, in delaying the progression of cancer for patients receiving treatment with RenovoGem versus standard-of-care....23 patients were randomized to intra-arterial (IA) gemcitabine (RenovoGem investigational treatment) arm and 22 patients to continuation of intravenous (IV) gemcitabine and nab-paclitaxel (standard-of-care) control arm....The median overall survival in the IV gemcitabine and nab-paclitaxel control arm was 10 months, versus 16 months in the IA RenovoGem arm, from time of randomization."

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

RenovoRx Announces ROTH Capital Key Opinion Leader (KOL) Webcast on June 15 (Businesswire) - "RenovoRx, Inc...announced that ROTH Capital will host a Key Opinion Leader (KOL) webcast with Dr. Michael Pishvaian, Principal Investigator of the Phase III TIGeR-PaC clinical trial and Director of the Gastrointestinal, Developmental Therapeutics, and Clinical Research Programs at Johns Hopkins University. The webcast is scheduled for Thursday, June 15, 2023 at 10 a.m. ET. The webcast will be moderated by Roth Capital, and discuss the recent interim analysis of the pivotal TIGeR-PaC study and its potential practice-changing impact in the oncology community.... Additionally, Dr. Pishvaian will be presenting new secondary endpoint data from the TIGeR-PaC study interim analysis in a late-breaking oral presentation at the upcoming ESMO World Congress on Gastrointestinal Cancer (ESMO GI)."

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

RenovoRx Announces Late-Breaking Oral Presentation at 2023 ESMO World Congress on Gastrointestinal Cancer (Businesswire) - "RenovoRx...announced the acceptance of a late-breaking oral presentation for its lead product candidate RenovoGem, in the treatment of locally advanced pancreatic cancer (LAPC), at the upcoming ESMO World Congress on Gastrointestinal Cancer (ESMO GI). The conference will be held June 28 – July 1, 2023, in Barcelona, Spain, with the presentation scheduled for Thursday, June 29, 2023, at 8:50 AM CEST....The presentation will feature new secondary endpoint data from the first interim analysis triggered in the Phase III TIGeR-PaC study – a multi-center, open-label clinical trial....The study is designed to randomize 114 patients. Final analysis will be conducted after 86 events (deaths) from the stereotactic body radiation therapy (SBRT) population."

Late-breaking abstract • P3 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor