MOUNTAIN VIEW, Calif., Nov. 19, 2025 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (Nasdaq: RNXT) (“RenovoRx” or “the Company”), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, FDA-cleared drug-delivery device, today announced that Chief Executive Officer Shaun Bagai will participate in the Alliance Global Partners (AGP) Emerging AgBiotech/Bio-Solutions Virtual Showcase. The event will be hosted by Scott Henry, Managing Director and Healthcare Analyst ...

Core Insights - RenovoRx reported a year-to-date revenue of approximately $900,000 as of the end of Q3 2025, indicating strong commercial progress and increasing market demand for its RenovoCath device [2][3][14] - The company has expanded its customer base from five to 14 approved cancer centers for RenovoCath, with additional quotes requested from 10 more centers, reflecting growing physician interest and satisfaction [4][5][8] - RenovoRx's cash position as of September 30, 2025, was $10 million, which is expected to support ongoing commercialization efforts and the completion of its Phase III clinical trial [15][21] Commercialization Update - The commercialization strategy for RenovoCath has shown progress, with Q3 2025 revenues reaching approximately $266,000, driven by new customer orders and repeat purchases [14][3] - The company has engaged with numerous physicians and medical institutions, indicating a strong interest in utilizing RenovoCath for targeted drug delivery [4][5] - RenovoRx aims to integrate its TAMP™ therapy into standard care practices to improve patient outcomes [2][10] Clinical Research and Development - The Phase III TIGeR-PaC trial is on track for enrollment completion in early 2026, with final data expected in 2027 [10][12] - A new post-marketing registry study has been launched to gather real-world evidence on the use of RenovoCath, with initial patient procedures already initiated [12][10] - The company has strengthened its Scientific Advisory Board with the addition of experts in oncology, enhancing its clinical development capabilities [11] Financial Highlights - For Q3 2025, RenovoRx reported a net loss of $2.9 million, compared to a net loss of $2.5 million in Q3 2024, reflecting ongoing investments in R&D and commercialization [17][24] - Research and development expenses were $1.7 million for the quarter, consistent with the previous year, indicating continued commitment to clinical trials [16][24] - Selling, general, and administrative expenses increased to approximately $1.7 million, up from $1.2 million in the prior year, reflecting the company's growth efforts [17][24] Market Potential - The initial total addressable market (TAM) for RenovoCath is estimated at approximately $400 million in peak annual U.S. sales, with potential for several billion dollars as the platform expands into additional indications [9][26] - The company is actively exploring further revenue-generating activities to meet anticipated demand for RenovoCath [29]

Core Insights - RenovoRx, Inc. is participating in the Canaccord Genuity MedTech, Diagnostics & Digital Health & Services Forum on November 20, 2025, where CEO Shaun Bagai will discuss the company's commercialization progress and ongoing clinical trials [1][2][3] Company Overview - RenovoRx is a life sciences company focused on developing targeted oncology therapies and commercializing RenovoCath, a patented FDA-cleared drug-delivery device aimed at addressing high unmet medical needs [4] - The company's Trans-Arterial Micro-Perfusion (TAMP™) therapy platform allows for targeted therapeutic delivery near tumor sites, potentially reducing toxicities compared to systemic intravenous therapy [4] Clinical Trials and Studies - The ongoing Phase III TIGeR-PaC clinical trial is evaluating RenovoRx's drug-device combination product candidate, intra-arterial gemcitabine (IAG), for locally advanced pancreatic cancer [2][5] - A post-marketing observational registry study has been launched to assess long-term safety signals and survival outcomes for patients treated with RenovoCath [2] Commercialization Efforts - RenovoRx has received its first commercial purchase orders for RenovoCath devices as of December 2024, with several customers placing repeat orders [7] - The company is expanding its customer base, including high-volume National Cancer Institute-designated centers, to meet anticipated demand [7] Regulatory Status - IAG, the combination product candidate, is under investigation and has not yet been approved for commercial sale [6] - RenovoCath with gemcitabine has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, granting seven years of market exclusivity upon FDA approval [6]

Core Insights - RenovoRx, Inc. is set to host its third quarter 2025 financial results and business highlights conference call on November 13, 2025, at 4:30 p.m. ET [1][3] - The management will discuss developments related to the RenovoCath device commercialization and ongoing clinical trials, including the Phase III TIGeR-PaC trial for locally advanced pancreatic cancer [2][5] Company Overview - RenovoRx is a life sciences company focused on developing targeted oncology therapies and commercializing the RenovoCath device, which is FDA-cleared for local drug delivery [4][6] - The company utilizes a patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform designed to deliver therapeutics directly to tumor sites, potentially reducing systemic toxicity [4][6] Clinical Trials and Product Development - The company is evaluating a novel drug-device combination product candidate, intra-arterial gemcitabine (IAG), in the ongoing Phase III TIGeR-PaC trial [5][6] - IAG has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, granting seven years of market exclusivity upon FDA approval [6] Commercialization Efforts - RenovoRx is actively commercializing its TAMP technology and has received its first commercial purchase orders for RenovoCath devices as of December 2024 [7] - The company is expanding its customer base, including high-volume National Cancer Institute-designated centers, and is exploring further revenue-generating activities [7]

Core Insights - Celcuity Inc. is recognized as one of the 12 best performing healthcare stocks currently available for investment [1] - The company focuses on developing targeted oncology therapies, particularly for solid tumors like advanced breast cancer, with its lead drug candidate being gedatolisib [2] Company Overview - Celcuity Inc. (NASDAQ:CELC) is a clinical-stage biotechnology firm specializing in targeted therapies for oncology [2] - Gedatolisib targets the PI3K and mTOR pathways, which are crucial in tumor growth and resistance, aiming to enhance outcomes for patients with hormone receptor-positive, HER2-negative advanced breast cancer [2] Regulatory Milestones - In August 2025, the U.S. FDA accepted Celcuity's New Drug Application (NDA) for gedatolisib under the Real-Time Oncology Review (RTOR) program, facilitating a quicker regulatory process [3] - The company initiated its rolling submission in September and anticipates completion by the fourth quarter of 2025 [3] - Strong results from the Phase 3 VIKTORIA-1 trial indicated that gedatolisib significantly reduced disease progression risk and improved progression-free survival in the PIK3CA wild-type cohort [3] Financial Position - To bolster its late-stage development and prepare for commercialization, Celcuity expanded its senior secured credit facility to $500 million [4] - This additional capital enhances the company's financial stability, alleviates liquidity concerns, and ensures resources are available as it moves towards potential FDA approval and market launch [4]

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