RNXT RenovoRx Inc.

3.34
-0.09  -3%
Previous Close 3.43
Open 3.45
52 Week Low 3.09
52 Week High 16.74
Market Cap $29,753,221
Shares 8,908,150
Float 6,746,108
Enterprise Value $33,175,384
Volume 26,365
Av. Daily Volume 578,106
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Drug Pipeline

Drug Stage Notes
RenovoGem - (TIGeR-PaC)
Locally advanced pancreatic cancer (LAPC)
Phase 3
Phase 3
Phase 3 initial data reported an increased survival benefit from RenovoTAMP with a median overall survival of 23.1 months. In addition, treatment via the superior mesenteric artery (SMA) delivered greatest survival benefits, with median overall survival of 31.7 months when compared with treatment via other arteries, noted November 11, 2021.
RenovoGem
Cholangiocarcinoma
Phase 2/3
Phase 2/3
Phase 2/3 trial planned.

Latest News

  1. Presentation Featured RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion) and the Phase 3 TIGeR-PaC Clinical Trial

    RenovoRx, Inc. ("RenovoRx" or the "Company") (NASDAQ:RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announced that Dr. Ripal Gandhi, M.D., FSIR, FSVM, a Principal Investigator in the Company's Phase 3 TIGeR-PaC study, presented ‘Trans-arterial Treatment Option in Pancreas Cancer' at the recent 2022 SPECTRUM Conference. Dr. Gandhi is professor of Interventional Radiology at the Miami Cancer Institute and Miami Cardiac and Vascular Institute, Florida International University Herbert Wertheim College of Medicine. The 2022 SPECTRUM conference was held last weekend, January 14-16, 2022, at the…

    Presentation Featured RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion) and the Phase 3 TIGeR-PaC Clinical Trial

    RenovoRx, Inc. ("RenovoRx" or the "Company") (NASDAQ:RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announced that Dr. Ripal Gandhi, M.D., FSIR, FSVM, a Principal Investigator in the Company's Phase 3 TIGeR-PaC study, presented ‘Trans-arterial Treatment Option in Pancreas Cancer' at the recent 2022 SPECTRUM Conference. Dr. Gandhi is professor of Interventional Radiology at the Miami Cancer Institute and Miami Cardiac and Vascular Institute, Florida International University Herbert Wertheim College of Medicine. The 2022 SPECTRUM conference was held last weekend, January 14-16, 2022, at the Nobu Hotel in Miami Beach, Florida.

    Since 2018, Dr. Gandhi has played a pivotal role in the TIGeR-PaC clinical trial as the PI for the Miami Cancer Institute. The TIGeR-PaC study is evaluating the Company's novel therapy platform, RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion) as a potential treatment option for locally advanced pancreatic cancer (LAPC) that may extend patient survival, reduce the typical, often debilitating side-effects associated with systemic chemotherapy (delivered intra-venously), and ultimately improve quality of life for pancreatic cancer patients.

    Dr. Gandhi's presentation at the 2022 SPECTRUM Conference provides an overview of the RenovoTAMP platform and supportive published research. The presentation showcased RenovoRx's RR1 Phase I/II and RR2 Observational Registry studies that suggests that when RenovoTAMP is used in combination with radiation therapy, arterial microvasculature may be reduced, thereby minimizing chemotherapy leakage during delivery, and increasing the chemotherapy directly reaching the tumor – resulting in targeted delivery and reduced systemic side effects. In addition, Dr. Gandhi also shared preliminary pharmacokinetic data (data describing the absorption, distribution, metabolism, and excretion of chemotherapy) from five patients in the TIGeR-PaC study, which demonstrates an approximate two-thirds reduction in systemic gemcitabine, when compared to systemic levels in historical control patients receiving traditional IV infusion of gemcitabine. This data suggests that by using RenovoTAMP for targeted delivery of chemotherapy, the systemic impacts of chemotherapy may be being reduced.

    "We appreciate Dr. Gandhi, a recognized expert specializing in minimally invasive treatments for cancer, both in his role as a Principal Investigator for the TIGeR-PaC study supporting our patients and their families, and for his ongoing efforts to educate clinicians throughout the medical community on the potential for RenovoTAMP as an option for the treatment of their patients with LAPC, " stated Dr. Ramtin Agah, Chief Medical Officer and Co-Founder of RenovoRx. He continued, "Our foundational studies provided support for the potential for intra-arterial delivery via RenovoTAMP to improve patient survival and counter the tolerability issues inherent to chemotherapy, which improves quality of life for patients during this critical time. Our team continues to make progress enrolling our Phase 3 clinical trial and looks forward to reporting on the interim data read out."

    View Dr. Gandhi's presentation, titled "Trans-arterial Treatment Option in Pancreas Cancer," at https://renovorx.com.

    About the 2022 SPECTRUM Conference

    The SPECTRUM conference offers attendees a comprehensive review of a variety of oncological diseases, combined with the latest developments in medical, interventional and surgical therapeutic options across multiple disciplines. SPECTRUM is both didactic and interactive with panel discussions, instructive case presentations and hands-on workshops focused on hepatocellular carcinoma, lung cancer, metastatic colorectal cancer, cholangiocarcinoma and liver metastases, renal and prostate cancer, pancreatic cancer, neuroendocrine and musculoskeletal tumors.

    About RenovoRx, Inc.

    RenovoRx is a clinical-stage biopharmaceutical company focused on fighting cancer through the localized treatment of difficult to treat tumors via its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMPTM) therapy platform. RenovoTAMP utilizes approved chemotherapeutics with validated mechanisms of action and well-established safety and side effect profiles, with the goal of increasing their efficacy, improving their safety, and widening their therapeutic window. RenovoRx's lead product candidate, RenovoGemTM, is a combination of gemcitabine and our patented delivery system, RenovoCath®, and is regulated by the FDA as a novel oncology drug product to treat unresectable locally advanced pancreatic cancer (LAPC). RenovoGem is currently being studied in the Phase 3 TIGeR-PaC trial for the treatment of LAPC.

    RenovoRx's patent portfolio includes seven U.S. patents for its technology. RenovoRx has been granted Orphan Drug Designation for intra-arterial delivery of gemcitabine for the treatment of both pancreatic cancer and bile duct cancer.

    RenovoRx won the Drug Delivery Technology category of the Fierce Innovation Awards – Life Sciences Edition 2020 for its RenovoTAMP technology.

    Learn more by visiting the RenovoRx website or following us on Facebook, LinkedIn and Twitter.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding our Phase 1 (RR1) and Observational Registry (RR2) studies, statements regarding the potential of RenovoTAMPTM, RenovoCath® or RenovoGemTM or regarding our ongoing TIGeR-PaC Phase 3 clinical trial in LAPC, and statements regarding the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, clinical trials, therapy platform, business plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these forward-looking statements. These statements may be identified using words such as "may," "expects," "plans," "aims," "anticipates," "believes," "forecasts," "estimates," "intends," and "potential," or the negative of these terms or other comparable terminology regarding RenovoRx's expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research programs; our ability to use and expand our therapy platform to build a pipeline of product candidates; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; the commercialization potential of our product candidates, if approved; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; negative impacts of the COVID-19 pandemic on our operations; and other risks.

    Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that we file from time to time with the Securities and Exchange Commission.

    Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.

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  2. RenovoRx, Inc. (NASDAQ:RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announced that Shaun Bagai, Chief Executive Officer, will participate in the H.C. Wainwright Bioconnect Virtual Conference on behalf of RenovoRx. The conference will be held January 10-13, 2022.

    Mr. Bagai's investor presentation will be available on-demand beginning January 10th at 7:00 am EST.

    Management will be available during the H.C. Wainwright Bioconnect conference for 1-on-1 meetings with the investment community. To schedule a meeting please reach out to your H.C. Wainwright representative or KCSA Strategic Communications by emailing .

    For further information about the H.C. Wainwright Bioconnect conference and…

    RenovoRx, Inc. (NASDAQ:RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announced that Shaun Bagai, Chief Executive Officer, will participate in the H.C. Wainwright Bioconnect Virtual Conference on behalf of RenovoRx. The conference will be held January 10-13, 2022.

    Mr. Bagai's investor presentation will be available on-demand beginning January 10th at 7:00 am EST.

    Management will be available during the H.C. Wainwright Bioconnect conference for 1-on-1 meetings with the investment community. To schedule a meeting please reach out to your H.C. Wainwright representative or KCSA Strategic Communications by emailing .

    For further information about the H.C. Wainwright Bioconnect conference and to register to attend virtually click here.

    A webcast of the event will be available for a limited time on the Events page in the Investors section of the Company's website at https://renovorx.com/investors/news-events/events.

    About RenovoRx, Inc.

    RenovoRx is a clinical-stage biopharmaceutical company focused on fighting cancer through the localized treatment of difficult to treat tumors via its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMPTM) therapy platform. RenovoTAMP utilizes approved chemotherapeutics with validated mechanisms of action and well-established safety and side effect profiles, with the goal of increasing their efficacy, improving their safety, and widening their therapeutic window. RenovoRx's lead product candidate, RenovoGemTM, is a combination of gemcitabine and our patented delivery system, RenovoCath®, and is regulated by the FDA as a novel oncology drug product to treat unresectable locally advanced pancreatic cancer (LAPC). RenovoGem is currently being studied in the Phase 3 TIGeR-PaC trial for the treatment of LAPC.

    RenovoRx's patent portfolio includes seven U.S. patents for its technology. RenovoRx has been granted Orphan Drug Designation for intra-arterial delivery of gemcitabine for the treatment of both pancreatic cancer and bile duct cancer.

    RenovoRx won the Drug Delivery Technology category of the Fierce Innovation Awards – Life Sciences Edition 2020 for its RenovoTAMP technology.

    Learn more by visiting the RenovoRx website or following us on Facebook, LinkedIn and Twitter.

    About H.C. Wainwright & Co.

    H.C. Wainwright is a full‐service investment bank dedicated to providing corporate finance, strategic advisory and related services to public and private companies across multiple sectors and regions. H.C. Wainwright & Co. also provides research and sales and trading services to institutional investors. According to Sagient Research Systems, H.C. Wainwright's team is ranked as the #1 Placement Agent in terms of aggregate CMPO (confidentially marketed public offering), RD (registered direct offering) and PIPE (private investment in public equity) executed cumulatively since 1998.

    For more information visit H.C. Wainwright & Co. on the web at www.hcwco.com

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  3. RenovoRx, Inc. (NASDAQ:RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today reported its unaudited financial results for the third quarter ended September 30, 2021.

    "The third quarter of 2021 marked an important juncture in the growth of our company as we completed our IPO in late August and our seventh U.S. patent was issued for our RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion) therapy platform. Our team remains patient-focused, supporting the clinical sites, their patients and families enrolled in our Phase 3 TIGeR-PaC clinical trial for the treatment of locally advanced pancreatic cancer (LAPC)," said Shaun Bagai, Chief Executive Officer of RenovoRx.

    Mr. Bagai added, "At two recent pancreatic cancer-focused…

    RenovoRx, Inc. (NASDAQ:RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today reported its unaudited financial results for the third quarter ended September 30, 2021.

    "The third quarter of 2021 marked an important juncture in the growth of our company as we completed our IPO in late August and our seventh U.S. patent was issued for our RenovoTAMP (RenovoRx Trans-Arterial Micro-Perfusion) therapy platform. Our team remains patient-focused, supporting the clinical sites, their patients and families enrolled in our Phase 3 TIGeR-PaC clinical trial for the treatment of locally advanced pancreatic cancer (LAPC)," said Shaun Bagai, Chief Executive Officer of RenovoRx.

    Mr. Bagai added, "At two recent pancreatic cancer-focused meetings, we presented incremental positive study data from our foundational clinical trials that support the potential for more tolerable and targeted treatment of LAPC through intra-arterial delivery of chemotherapy. Through preliminary pharmacokinetic data (data describing the absorption, distribution, metabolism, and excretion of chemotherapy) from five patients in the TIGeR-PaC study, we found an approximate two-thirds reduction in systemic gemcitabine, when compared to systemic levels in historical control patients receiving traditional IV infusion of gemcitabine. This finding reinforces the potential for intra-arterial delivery to improve tolerability, reduce typical, and often debilitating, side effects associated with systemic chemotherapy, and ultimately improve quality of life. In addition, the final data we presented from our RR2 Observational Registry Study suggests that when RenovoTAMP is used in combination with radiation therapy, it may reduce arterial microvasculature, which minimizes leakage during chemotherapy delivery, and thereby increases the chemotherapy directly reaching the tumor."

    GAAP Financial Results

    For the Third Quarter Ended September 30, 2021 (Unaudited)

    • Net loss for the third quarter of 2021 was $1.5 million, compared to $1.1 million for the third quarter of 2020.
    • Research and development expenses for the third quarter of 2021 were $0.8 million, compared to $0.7 million for the same period in 2020. The increase was primarily due to higher clinical development personnel costs.
    • General and administrative expenses for the third quarter of 2021 were $0.6 million, compared to $0.2 million for the same period of 2020. The increase was primarily due to higher professional and consulting expenses related to preparing for our IPO in August 2021, including personnel costs and insurance costs for directors and officers liability insurance.

    For the Nine Months Ended September 30, 2021 (Unaudited)

    • Net loss for the nine months ended September 30, 2021 was $4.0 million, compared to $2.9 million for the same period in 2020.
    • Research and development expenses for the nine months ended September 30, 2021 and 2020 were each $1.9 million. Research and development expenses during the 2021 period were higher overall, primarily due to higher clinical development personnel costs, but were offset by lower leased software expenses and payments received from clinical sites for the use of our RenovoCath® delivery system in our Phase 3 clinical trial.
    • General and administrative expenses for the nine months ended September 30, 2021 were $1.4 million, compared to $0.6 million for the same period of 2020. The increase was primarily due to higher professional and consulting expenses related to preparing for our IPO in August 2021, including personnel costs and insurance costs for directors and officers liability insurance.

    As of September 30, 2021, the Company had cash and cash equivalents of $17.7 million and no outstanding debt obligations.

    About the Phase 3 TIGeR-PaC Clinical Trial

    The TIGeR-PaC clinical trial is a randomized multi-center study using the RenovoTAMP platform to evaluate RenovoRx's first product candidate, RenovoGem to treat unresectable LAPC through the intra-arterial delivery of gemcitabine, an approved chemotherapeutic agent. TIGeR-PaC is currently enrolling locally advanced, unresectable pancreatic cancer patients. To learn more about the study and the participating clinical trial sites, visit https://renovorx.com/clinical-trial/.

    About RenovoRx, Inc.

    RenovoRx is a clinical-stage biopharmaceutical company focused on fighting cancer through the localized treatment of difficult to treat tumors via its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP) therapy platform. RenovoTAMP delivers approved small molecule chemotherapeutic agents locally to the solid tumors. RenovoRx's lead product candidate, RenovoGem, uses intra-arterial delivery of gemcitabine, an approved chemotherapeutic agent, to treat unresectable locally advanced pancreatic cancer (LAPC) and is currently being studied in the Phase 3 TIGeR-PaC trial for the treatment of LAPC.

    RenovoRx's patent portfolio includes seven U.S. patents for its technology. RenovoRx has been granted Orphan Drug Designation for intra-arterial delivery of gemcitabine for the treatment of both pancreatic cancer and bile duct cancer.

    RenovoRx won the Drug Delivery Technology category of the Fierce Innovation Awards – Life Sciences Edition 2020 for its RenovoTAMP technology.

    Learn more by visiting the RenovoRx website or following us on Facebook, LinkedIn and Twitter.

    Forward-looking statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding our Phase 1 (RR1) and Observational Registry (RR2) studies, statements regarding the potential of RenovoTAMP, RenovoCath® or RenovoGem or regarding our ongoing TIGeR-PaC Phase 3 clinical trial in LAPC, and statements regarding the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, clinical trials, therapy platform, business plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these forward-looking statements. These statements may be identified using words such as "may," "expects," "plans," "aims," "anticipates," "believes," "forecasts," "estimates," "intends," and "potential," or the negative of these terms or other comparable terminology regarding RenovoRx's expectations, strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research programs; our ability to use and expand our therapy platform to build a pipeline of product candidates; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; the commercialization potential of our product candidates, if approved; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; negative impacts of the COVID-19 pandemic on our operations; general economic and market conditions and other risks.

    Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that we file from time to time with the Securities and Exchange Commission.

    Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.

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  4. Study Results Validate Potential for Intra-arterial Chemotherapy Delivery for the Treatment of Pancreatic Cancer

    RenovoRx, Inc. (NASDAQ:RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announced that it will be presenting an ePoster at the 2021 Pancreas Club Annual Meeting being held virtually on November 11-12, 2021.

    The poster describes the RR2 Observational Registry Study, which used RenovoRx's novel therapy platform, RenovoTAMP™ (RenovoRx Trans-Arterial Micro-Perfusion), to deliver gemcitabine, an approved chemotherapeutic agent, intra-arterially to the pancreatic tumor. The results of this study along with the prior Phase 1 study form the foundation of RenovoRx's ongoing randomized, multi-center Phase…

    Study Results Validate Potential for Intra-arterial Chemotherapy Delivery for the Treatment of Pancreatic Cancer

    RenovoRx, Inc. (NASDAQ:RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announced that it will be presenting an ePoster at the 2021 Pancreas Club Annual Meeting being held virtually on November 11-12, 2021.

    The poster describes the RR2 Observational Registry Study, which used RenovoRx's novel therapy platform, RenovoTAMP™ (RenovoRx Trans-Arterial Micro-Perfusion), to deliver gemcitabine, an approved chemotherapeutic agent, intra-arterially to the pancreatic tumor. The results of this study along with the prior Phase 1 study form the foundation of RenovoRx's ongoing randomized, multi-center Phase 3 clinical trial (TIGeR-PaC) of its lead product candidate, RenovoGem™, for the treatment of unresectable, locally advanced pancreatic cancer (LAPC).

    The Registry Study, which was designed to assess the effectiveness and feasibility of intra-arterial therapeutic treatment of patients with LAPC, validated prior radiation and treatment location as predictors of overall survival. It included 25 patients (10 treatment naïve, 6 with prior chemotherapy, 8 with prior chemotherapy and radiation, and 1 that had undergone prior Whipple surgery). Patients with prior radiation treatment demonstrated increased survival benefit from RenovoTAMP (median overall survival of 23.1 months) when compared to patients with prior chemotherapy (median overall survival of 16.6 months) and treatment naïve patients (median overall survival of 5.7 months). In addition, treatment via the superior mesenteric artery (SMA) delivered greatest survival benefits, with median overall survival of 31.7 months when compared with treatment via other arteries. The survival benefit for patients treated with RenovoTAMP supports the rationale underlying the potential for intra-arterial, targeted chemotherapy delivery as a treatment for LAPC.

    "Standard of care for patients diagnosed with unresectable LAPC is intravenous (IV) systemic chemotherapy, which both has significant side effects and is limited in its effectiveness by the lack of visible tumor feeders to pancreatic tumors," said Dr. Ramtin Agah, Chief Medical Officer and Co-Founder of RenovoRx. "Based on the results of our foundational clinical trials, intra-arterial delivery of chemotherapy via RenovoTAMP not only reduced the tolerability issues associated with systemic chemotherapy, but by targeting delivery of treatment in close proximity to the tumor and pancreatic tissue, it also demonstrated improved patient survival rate."

    The details of the presentation are as follows:

    Title: Treating locally advanced pancreatic cancer with a novel, dual-occlusion balloon catheter

    Poster Number: P108

    Authors: H. Charles Li; Carter Hultman; Alexander Rosemurgy, MD; J. Augusto Bastidas, MD; Reza Malek, MD; Emmanuel Zervos, MD; Steven Goldin, MD; Peter Muscarella, MD; Charles Nutting, DO; Barish Edil, MD; Ramtin Agah, MD

    A recording of the presentation will be available on RenovoRx's website.

    About the Phase 3 TIGeR-PaC Clinical Trial

    The TIGeR-PaC clinical trial is a randomized multi-center study using the RenovoTAMP platform to evaluate RenovoRx's first product candidate, RenovoGem to treat unresectable LAPC through the intra-arterial delivery of gemcitabine, an approved chemotherapeutic agent. TIGeR-PaC is currently enrolling locally advanced, unresectable pancreatic cancer patients. To learn more about the study and the participating clinical trial sites, visit https://renovorx.com/clinical-trial/.

    About RenovoRx, Inc.

    RenovoRx is a clinical-stage biopharmaceutical company focused on fighting cancer through the localized treatment of difficult to treat tumors via its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP™) therapy platform. RenovoTAMP delivers approved small molecule chemotherapeutic agents locally to the solid tumors. RenovoRx's lead product candidate, RenovoGem™, uses intra-arterial delivery of gemcitabine, an approved chemotherapeutic agent, to treat unresectable locally advanced pancreatic cancer (LAPC) and is currently being studied in the Phase 3 TIGeR-PaC trial for the treatment of LAPC.

    RenovoRx's patent portfolio includes seven U.S. patents for its technology. RenovoRx has been granted Orphan Drug Designation for intra-arterial delivery of gemcitabine for the treatment of both pancreatic cancer and bile duct cancer.

    RenovoRx won the Drug Delivery Technology category of the Fierce Innovation Awards – Life Sciences Edition 2020 for its RenovoTAMP technology.

    Learn more by visiting the RenovoRx website or following us on Facebook, LinkedIn and Twitter.

    Forward-looking statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding our Phase 1 (RR1) and Observational Registry (RR2) studies, statements regarding the potential of RenovoTAMP™, RenovoCath® or RenovoGem™ or regarding our ongoing TIGeR-PaC Phase 3 clinical trial in LAPC, and statements regarding the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, clinical trials, therapy platform, business plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these forward-looking statements. These statements may be identified using words such as "may," "expects," "plans," "aims," "anticipates," "believes," "forecasts," "estimates," "intends," and "potential," or the negative of these terms or other comparable terminology regarding RenovoRx's expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research programs; our ability to use and expand our therapy platform to build a pipeline of product candidates; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; the commercialization potential of our product candidates, if approved; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; negative impacts of the COVID-19 pandemic on our operations; and other risks.

    Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that we file from time to time with the Securities and Exchange Commission.

    Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.

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  5. RenovoRx Phase 3 TIGeR-PaC Clinical Trial Preliminary Pharmacokinetic Data Featured

    RenovoRx, Inc. (NASDAQ:RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announced its novel therapy platform, RenovoTAMPTM (RenovoRx Trans-Arterial Micro-Perfusion), will be highlighted during a presentation by expert panelist, Dr. Ripal Gandhi, at the Miami Cancer Institute's New Advances in the Management of Pancreatic Cancer CME course this evening.

    Dr. Gandhi, a Principal Investigator in RenovoRx's ongoing Phase 3 TIGeR-PaC study, and Professor of Interventional Radiology at the Miami Cancer Institute and Miami Cardiac and Vascular Institute, Florida International University Herbert Wertheim College of Medicine, will describe…

    RenovoRx Phase 3 TIGeR-PaC Clinical Trial Preliminary Pharmacokinetic Data Featured

    RenovoRx, Inc. (NASDAQ:RNXT), a biopharmaceutical company and innovator in targeted cancer therapy, today announced its novel therapy platform, RenovoTAMPTM (RenovoRx Trans-Arterial Micro-Perfusion), will be highlighted during a presentation by expert panelist, Dr. Ripal Gandhi, at the Miami Cancer Institute's New Advances in the Management of Pancreatic Cancer CME course this evening.

    Dr. Gandhi, a Principal Investigator in RenovoRx's ongoing Phase 3 TIGeR-PaC study, and Professor of Interventional Radiology at the Miami Cancer Institute and Miami Cardiac and Vascular Institute, Florida International University Herbert Wertheim College of Medicine, will describe the results from initial clinical studies of RenovoTAMP used in combination with radiation therapy and its benefits when managing patients with stage 3 locally advanced pancreatic cancer (LAPC). He will also review the key stages of the TIGeR-PaC protocol which uses RenovoTAMP for the intra-arterial delivery of gemcitabine, an approved chemotherapeutic agent, to treat unresectable LAPC. To highlight a critical difference between intravenous (IV) and intra-arterial (IA) chemotherapy, Dr. Gandhi will present pharmacokinetic data, or data describing the drug absorption/distribution/metabolism/excretion of gemcitabine from five patients in the Phase 3 TIGeR-PaC study that received intra-arterial gemcitabine. The data demonstrates an approximately two-thirds reduction in systemic gemcitabine when compared to systemic levels in patients traditionally receiving IV infusion of gemcitabine.

    "This innovative therapy platform is enabling the targeted treatment of inoperable LAPC with decreased side effects typical of systemic chemotherapy, while shifting the focus to what is most important to our patients: improving quality of life and allowing them to spend more time with their family and loved ones," said Dr. Gandhi. "RenovoTAMP, when used in combination with radiation therapy, is designed to reduce arterial microvasculature, thereby minimizing leakage during drug delivery and enhancing drug delivery directly to the tumor."

    A copy and recording of Dr. Gandhi's presentation, titled "Potential Future Innovative Strategy for Pancreatic Cancer: Intra-Arterial Chemotherapy," will be available on RenovoRx's website at https://renovorx.com.

    About the Phase 3 TIGeR-PaC Clinical Trial

    The TIGeR-PaC clinical trial is a randomized multi-center study using the RenovoTAMPTM platform to evaluate RenovoRx's first product candidate, RenovoGemTM to treat unresectable LAPC through the intra-arterial delivery of gemcitabine, an approved chemotherapeutic agent. TIGeR-PaC is currently enrolling locally advanced, unresectable pancreatic cancer patients. To learn more about the study and the participating clinical trial sites, visit https://renovorx.com/clinical-trial/.

    About RenovoRx, Inc.

    RenovoRx is a clinical-stage biopharmaceutical company focused on fighting cancer through the localized treatment of difficult to treat tumors via its proprietary RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMPTM) therapy platform. RenovoTAMP delivers approved small molecule chemotherapeutic agents locally to the solid tumors. RenovoRx's lead product candidate, RenovoGemTM, uses intra-arterial delivery of gemcitabine, an approved chemotherapeutic agent, to treat unresectable locally advanced pancreatic cancer (LAPC) and is currently being studied in the Phase 3 TIGeR-PaC trial for the treatment of LAPC.

    RenovoRx's patent portfolio includes seven U.S. patents for its technology. RenovoRx has been granted Orphan Drug Designation for intra-arterial delivery of gemcitabine for the treatment of both pancreatic cancer and bile duct cancer.

    RenovoRx won the Drug Delivery Technology category of the Fierce Innovation Awards – Life Sciences Edition 2020 for its RenovoTAMP technology.

    Learn more by visiting the RenovoRx website or following us on Facebook, LinkedIn and Twitter.

    Forward-looking statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding our Phase 1 (RR1) and Observational Registry (RR2) studies, statements regarding the potential of RenovoTAMPTM, RenovoCath® or RenovoGemTM or regarding our ongoing TIGeR-PaC Phase 3 clinical trial in LAPC, and statements regarding the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases. Statements that are not purely historical are forward-looking statements. The forward-looking statements contained herein are based upon our current expectations and beliefs regarding future events, many of which, by their nature, are inherently uncertain, outside of our control and involve assumptions that may never materialize or may prove to be incorrect. These may include estimates, projections and statements relating to our research and development plans, clinical trials, therapy platform, business plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied by these forward-looking statements. These statements may be identified using words such as "may," "expects," "plans," "aims," "anticipates," "believes," "forecasts," "estimates," "intends," and "potential," or the negative of these terms or other comparable terminology regarding RenovoRx's expectations strategy, plans or intentions, although not all forward-looking statements contain these words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, that could cause actual events to differ materially from those projected or indicated by such statements, including, among other things: the timing of the initiation, progress and potential results of our preclinical studies, clinical trials and our research programs; our ability to use and expand our therapy platform to build a pipeline of product candidates; our ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; our estimates of the number of patients who suffer from the diseases we are targeting and the number of patients that may enroll in our clinical trials; the commercialization potential of our product candidates, if approved; our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; future strategic arrangements and/or collaborations and the potential benefits of such arrangements; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; our ability to retain the continued service of our key personnel and to identify, hire and retain additional qualified personnel; the implementation of our strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; the pricing, coverage and reimbursement of our product candidates, if approved; developments relating to our competitors and our industry, including competing product candidates and therapies; negative impacts of the COVID-19 pandemic on our operations; and other risks.

    Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that RenovoRx files from time to time with the Securities and Exchange Commission.

    Forward-looking statements included herein are made as of the date hereof, and RenovoRx does not undertake any obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as required by law.

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