New Pharmacokinetic (PK) and Pharmacodynamic Data from Sub-Study in Phase III Trial Strengthens Scientific Basis for RenovoRx’s TAMP Therapy Platform as a Targeted Drug-Delivery Approach Data Shows a PK Profile that May Improve Clinical Efficacy and Decrease Clinical Side Effects with TAMP and Intra-Arterial Gemcitabine Versus Standard of Care Chemotherapy MOUNTAIN VIEW, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or “the Company”) (Nasdaq: RNXT), a life sciences company developing ...

Core Insights - Healthcare and biotechnology stocks experienced significant movements in after-hours trading, with several companies showing strong gains despite limited news flow [1] Company Summaries - Novo Nordisk A/S (NVO) saw a notable increase of 9.48%, closing at $52.66, following FDA approval of its Wegovy pill, the first oral GLP-1 medicine for obesity in the U.S., which is also approved to reduce cardiovascular risks [2] - Neumora Therapeutics, Inc. (NMRA) advanced 16.02% to $2.10, indicating investor interest possibly driven by broader sector momentum or speculative trading, as there were no specific news updates [3] - BioRestorative Therapies, Inc. (BRTX) rose 6.90% to $1.24, with investors reacting to a prior announcement regarding an FDA Type B meeting to discuss a potential accelerated BLA pathway for its BRTX-100 program for chronic lumbar disc disease [4] - RenovoRx, Inc. (RNXT) added 4.44% to close at $0.94, with earlier news of an accepted abstract submission for the ASCO Gastrointestinal Cancers Symposium 2026 contributing to investor interest [5] - IDEAYA Biosciences, Inc. (IDYA) gained 6.49% to $37.81, following the full enrollment of 435 patients in its Phase 2/3 trial for darovasertib, with expected data reporting in Q1 2026 [6] - Healthcare Triangle, Inc. (HCTI) climbed 6.72% to $1.43, with a recent announcement of an Advance Agreement for acquiring AI-powered customer experience firms, enhancing its position in global AI-driven solutions [7] - Alphatec Holdings, Inc. (ATEC) posted a modest gain of 2.80%, rising to $21.28, benefiting from ongoing investor confidence in the spine surgery provider [8]

Several biotechnology and life sciences companies posted notable gains in after-hours trading on Friday, reflecting investor interest in recent clinical and corporate developments.Kura Oncology, Inc. (KURA) led the group with a strong move higher. Shares rose to $10.57, up 7.42% (+0.73) in after-hours trading. While there was no fresh news on Friday, investors may still be reacting to Kura's December 8 announcement of new data from its KOMET-007 Phase 1a/1b trial. The study evaluated KOMZIFTI (ziftomenib) ...

Core Insights - RenovoRx, Inc. has announced the acceptance of its abstract submission for the ASCO Gastrointestinal Cancers Symposium 2026, focusing on its innovative targeted oncology therapies and the RenovoCath drug-delivery device [1][4] Company Overview - RenovoRx is a life sciences company specializing in targeted oncology therapies and has developed the FDA-cleared RenovoCath device for drug delivery [7] - The company aims to address high unmet medical needs in cancer treatment through its patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform [7] Clinical Trial Information - The ongoing Phase III TIGeR-PaC clinical trial evaluates the TAMP therapy platform for treating locally advanced pancreatic cancer (LAPC) [6][10] - A pharmacokinetic and pharmacodynamic sub-study will compare intra-arterial gemcitabine delivered via RenovoCath to standard intravenous chemotherapy [2][3] Presentation Details - The abstract presentation is scheduled for January 9, 2026, at the ASCO GI symposium in San Francisco, with specific time slots for the presentation [4][5] Financial Performance - In the first nine months of 2025, RenovoRx generated approximately $900,000 in revenue from RenovoCath sales, indicating early commercial traction [8] - The company is actively exploring additional revenue-generating activities to meet anticipated demand for its products [9]

PresentationShaun BagaiCEO, Secretary & Director Thank you for the opportunity, and thank you for those listening in, and I look forward to sharing our updates with you and the progress we've made to date as we are closing up an exciting year in 2025 and really planting the seeds and putting in the positive foundation for growth in 2026. My name is Shaun Bagai, CEO of RenovoRx. And here at RenovoRx, we are working on a new way to think about cancer. Unfortunately, when you think about new cancer therapeutic ...

Summary of RenovoRx Conference Call - December 09, 2025 Company Overview - **Company**: RenovoRx Inc. (NasdaqCM:RNXT) - **Industry**: Cancer therapeutics and medical devices Key Points and Arguments 1. **New Approach to Cancer Treatment**: RenovoRx is focusing on localizing therapy for cancers rather than solely targeting tumors, aiming to minimize patient toxicity while effectively treating cancer [2][3] 2. **Commercialization of RenovoCath Device**: The company has initiated the commercialization of its FDA-cleared RenovoCath device, generating over $900,000 in revenue year-to-date through Q3 2025 without a dedicated sales infrastructure [3][4] 3. **Market Potential**: The peak revenue potential for the RenovoCath device in the U.S. is estimated at over $400 million, based on indications and areas of use [4][12] 4. **TAMP Mechanism**: The proprietary Trans-Arterial Micro-Perfusion (TAMP) mechanism allows for localized chemotherapy delivery, significantly increasing drug concentration at the tumor site while reducing systemic exposure [5][8][9] 5. **Clinical Trials**: The pivotal phase III TIGeR-PaC study for locally advanced pancreatic cancer is progressing, with enrollment expected to complete in early 2026 and final data anticipated in 2027 [5][18] 6. **Patient Experience**: The TAMP procedure is outpatient, requiring only conscious sedation, and allows patients to receive treatment in about 90 minutes, contrasting with traditional chemotherapy that often requires longer hospital stays [10][11] 7. **Market Expansion**: Beyond pancreatic cancer, the device is applicable to other hypovascular tumors, including cholangiocarcinoma and non-small cell lung cancers, which could further expand the market [11][34] 8. **Sales Infrastructure**: A lean sales team has been established, with 14 centers approved to purchase the device and five actively using it, indicating strong initial market interest [14][15][26] 9. **Financial Position**: As of Q3 2025, RenovoRx reported over $10 million in cash and anticipates revenue growth in 2026, with a current cash burn of approximately $800,000 per month [24][34] 10. **Reimbursement and Margins**: The company has established reimbursement rates allowing for device pricing between $6,000 and $8,500, with current margins around 80%, expected to improve as manufacturing scales [12][35] Additional Important Content - **Regulatory Pathway**: The device was approved through the 510(k) pathway, allowing for a faster and simpler regulatory process compared to more invasive technologies [28][29] - **International Market Considerations**: While there is potential for international expansion, the focus remains on the U.S. market due to higher reimbursement rates and lower regulatory hurdles [28][29] - **Future Collaborations**: Ongoing discussions with medical device companies for potential partnerships or distribution arrangements are in place, indicating interest in the device's unique capabilities [37][38] - **Scientific Advisory Board**: The company has a strong advisory board with notable experts in oncology, enhancing its credibility and potential for clinical success [22] This summary encapsulates the key insights from the RenovoRx conference call, highlighting the company's innovative approach to cancer treatment, market potential, and strategic plans for growth.

Core Viewpoint - RenovoRx, Inc. is actively commercializing its innovative targeted oncology therapies, particularly focusing on the RenovoCath device, which has shown growing clinical demand and market traction [1][2][6] Group 1: Company Updates - CEO Shaun Bagai will present at the iAccess Alpha Virtual Best Ideas Winter Investment Conference on December 9, 2025, to discuss the company's commercial efforts and market traction [1][4] - Year-to-date revenue for RenovoRx reached approximately $900,000 by the end of September 30, 2025, indicating progress in its commercialization efforts [2][7] - The company has received its first commercial purchase orders for RenovoCath devices and has seen repeat orders from several customers, including high-volume National Cancer Institute-designated centers [7] Group 2: Clinical Research and Development - The ongoing Phase III TIGeR-PaC clinical trial is evaluating intra-arterial gemcitabine delivered via RenovoCath in patients with locally advanced pancreatic cancer [3][8] - RenovoRx is also conducting a post-marketing registry study to capture real-world data on the safety and effectiveness of RenovoCath in patients with solid tumors [3] - The company supports investigator-initiated trials in borderline resectable and oligometastatic pancreatic cancer, which may broaden the application of its TAMP™ therapy platform [3][6] Group 3: Product Information - RenovoCath is an FDA-cleared drug-delivery device designed for targeted therapeutic delivery, aiming to minimize toxicities compared to systemic intravenous therapy [5][6] - The device is indicated for temporary vessel occlusion and the delivery of fluids, including therapeutic agents, to specific sites in the peripheral vascular system [5][9] - RenovoCath with gemcitabine has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, providing seven years of market exclusivity upon FDA approval [10]

Summary of RenovoRx Conference Call (November 20, 2025) Company Overview - **Company**: RenovoRx (NasdaqCM:RNXT) - **Market Cap**: Approximately $30 million - **Focus**: Interventional oncology with a late-stage product in development and a commercial catheter device - **Current Stock Price**: Approximately $0.75 - **Analyst Rating**: Buy rating with a price target of $3 per share [1][17] Core Business and Product Development - **Product**: RenovoCath, a catheter device for localized chemotherapy - **Revenue**: Achieved $900,000 in revenue through Q3 2025 without a dedicated sales and marketing team [3][13] - **Market Potential**: Estimated peak sales potential for the catheter is about $400 million [3][8] - **Commercialization Strategy**: Initiated in early 2025, focusing on understanding market dynamics and barriers to adoption [3][9] Technology and Treatment Approach - **Innovative System**: Developed a new treatment method called TransArterial Microperfusion (TAMP) for localized chemotherapy [2][5] - **Mechanism of Action**: Allows for a hundred-fold increase in tissue concentration of chemotherapy compared to systemic delivery [7][8] - **Targeted Conditions**: Primarily focused on locally advanced pancreatic cancer, with ongoing phase III trials [4][10] Clinical Trials and Efficacy - **Phase III Trial**: Enrollment expected to complete early next year, with final data anticipated in 2027 [4][14] - **Survival Benefits**: Interim analysis shows a six-month survival benefit, with patients living approximately 21.5 months compared to 15.5 months in the control group [10][40] - **Quality of Life**: Notable 65% reduction in systemic toxicities and adverse events compared to traditional therapies [11][40] Market Dynamics and Sales Strategy - **Target Market**: Approximately 200 hospitals in the U.S. with specialized cancer centers [9] - **Sales Force**: Currently expanding with the hiring of a Senior Director of Sales and Marketing, along with additional sales representatives [9][20] - **Revenue Model**: Each patient may require multiple procedures, potentially generating $50,000 to $100,000 in revenue per patient [19][22] Financial Overview - **Cash Position**: $10 million in cash as of Q3 2025, with a monthly burn rate of $800,000 [16][44] - **Profitability Outlook**: Positive contribution margin on the device, with a goal to reach break-even with 25-50 hospitals actively using the device [22][23] Future Prospects and Strategic Initiatives - **Post-Marketing Registry Study**: Launched to track data on the use of RenovoCath across various cancers [12][13] - **Expansion Plans**: Exploring additional indications and potential partnerships with other biotech firms for drug-device combinations [42][43] - **Regulatory Strategy**: Aiming for a J-code drug reimbursement for the drug-device combination, which could significantly increase market potential [17] Key Takeaways - RenovoRx is positioned to disrupt traditional cancer treatment paradigms with its innovative localized chemotherapy approach - The company is on track to expand its market presence and revenue generation capabilities through strategic hiring and commercialization efforts - Clinical trial results and a strong focus on quality of life improvements are expected to drive adoption among oncologists and patients alike [10][11][40]

Core Insights - RenovoRx, Inc. is participating in the Alliance Global Partners Emerging AgBiotech/Bio-Solutions Virtual Showcase on November 20, 2025, where CEO Shaun Bagai will provide updates on the company's commercial efforts and market traction [1][2] Company Overview - RenovoRx is a life sciences company focused on developing targeted oncology therapies and commercializing RenovoCath, an FDA-cleared drug-delivery device [6][8] - The company aims to address high unmet medical needs through its patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform, which allows for targeted therapeutic delivery while minimizing toxicities associated with systemic intravenous therapy [6][8] Financial Performance - For the third quarter of 2025, RenovoRx reported year-to-date revenue of approximately $900,000, indicating progress in its commercial efforts [2] Clinical Research and Development - The ongoing Phase III TIGeR-PaC clinical trial is evaluating intra-arterial gemcitabine delivered via RenovoCath in patients with locally advanced pancreatic cancer [3][7] - The company is also conducting a post-marketing registry study to gather real-world data on the safety and effectiveness of RenovoCath in patients with solid tumors [3] - Investigator-initiated trials are being supported for borderline resectable and oligometastatic pancreatic cancer, designed to be cost-neutral while providing meaningful data [3] Product Information - RenovoCath is designed for the isolation of blood flow and delivery of fluids to selected sites in the peripheral vascular system, with applications including arteriography and chemotherapeutic drug infusion [5][6] - The combination product candidate, intra-arterial gemcitabine (IAG), is under investigation and has received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which grants seven years of market exclusivity upon FDA approval [8][9] Market Activity - RenovoRx has received its first commercial purchase orders for RenovoCath devices and is seeing repeat orders from customers, including high-volume National Cancer Institute-designated centers [9] - The company is exploring further revenue-generating activities to meet anticipated demand for its products [9]

Core Insights - The after-hours trading session on November 14, 2025, saw significant movements in biotech and therapeutics stocks due to various corporate updates and financial results [1] Company Summaries - Repare Therapeutics Inc. (RPTX) experienced a 30.32% increase, closing at $2.15, following the announcement of a definitive agreement for acquisition by XenoTherapeutics, with shareholders set to receive $1.82 per share plus a contingent value right. The company reported cash and cash equivalents of $112.6 million as of September 30, 2025, up from $109.5 million at the end of June [2] - Senti Biosciences, Inc. (SNTI) rose 7.45% to $1.73 after reporting a net loss of $18.1 million, or $0.69 per share, for Q3 2025. Cash and cash equivalents decreased to $12.2 million from $48.3 million at year-end 2024 [3] - Applied Therapeutics, Inc. (APLT) advanced 8.15% to $0.24, reporting a net loss of $19.0 million, or $0.13 per share, for Q3 2025, an improvement from a net loss of $68.6 million, or $0.48 per share, in the same period of 2024. Cash and cash equivalents totaled $11.9 million, down from $79.4 million at the end of 2024 [4] - RenovoRx, Inc. (RNXT) climbed 6.28% to $0.80, reporting revenues of approximately $266,000 for Q3 2025, with a net loss of $2.9 million compared to $2.5 million in the same period of 2024 [5] - Nuvalent, Inc. (NUVL) gained 9.33%, closing at $105.50, and announced plans for a webcast to discuss pivotal data for its investigational ALK-selective inhibitor in patients with advanced ALK-positive non-small cell lung cancer [6]