RenovoRx CEO to Provide Strategic Update During Fireside Chat on Thursday, April 3rd at 12:00 p.m. ET
RenovoRx (Nasdaq: RNXT) announced a strategic fireside chat scheduled for April 3, 2025, at 12:00 p.m. ET, where CEO Shaun Bagai will provide key updates on two main fronts:
1. Commercial Progress: Discussion of RenovoCath®, their FDA-cleared drug-delivery device, including updates on new purchase orders, reorders from cancer centers, and initial revenue generation.
2. Clinical Development: Updates on the ongoing Phase III TIGeR-PaC clinical trial, which evaluates their lead drug-device combination product candidate (IAG). This candidate combines intra-arterial gemcitabine delivery via RenovoCath using their proprietary Trans-Arterial Micro-Perfusion (TAMP™) platform for treating locally advanced pancreatic cancer (LAPC).
RenovoRx (Nasdaq: RNXT) ha annunciato una chiacchierata strategica programmata per il 3 aprile 2025, alle 12:00 ET, durante la quale il CEO Shaun Bagai fornirà aggiornamenti chiave su due fronti principali:
1. Progresso Commerciale: Discussione su RenovoCath®, il loro dispositivo per la somministrazione di farmaci approvato dalla FDA, inclusi aggiornamenti su nuovi ordini di acquisto, riordini da centri oncologici e generazione iniziale di entrate.
2. Sviluppo Clinico: Aggiornamenti sullo studio clinico di Fase III TIGeR-PaC, che valuta il loro principale candidato prodotto combinato farmaco-dispositivo (IAG). Questo candidato combina la somministrazione intra-arteriosa di gemcitabina tramite RenovoCath utilizzando la loro piattaforma proprietaria Trans-Arterial Micro-Perfusion (TAMP™) per il trattamento del cancro pancreatico localmente avanzato (LAPC).
RenovoRx (Nasdaq: RNXT) anunció una charla estratégica programada para el 3 de abril de 2025, a las 12:00 p.m. ET, donde el CEO Shaun Bagai proporcionará actualizaciones clave en dos frentes principales:
1. Progreso Comercial: Discusión sobre RenovoCath®, su dispositivo de entrega de medicamentos aprobado por la FDA, incluyendo actualizaciones sobre nuevos pedidos de compra, reordenes de centros oncológicos y generación inicial de ingresos.
2. Desarrollo Clínico: Actualizaciones sobre el ensayo clínico en curso de Fase III TIGeR-PaC, que evalúa su principal candidato de producto combinado de fármaco-dispositivo (IAG). Este candidato combina la entrega intra-arterial de gemcitabina a través de RenovoCath utilizando su plataforma propietaria Trans-Arterial Micro-Perfusion (TAMP™) para el tratamiento del cáncer de páncreas localmente avanzado (LAPC).
RenovoRx (Nasdaq: RNXT)는 2025년 4월 3일 오후 12시(ET)에 예정된 전략적 대담을 발표했으며, 이 자리에서 CEO Shaun Bagai가 두 가지 주요 분야에 대한 핵심 업데이트를 제공할 예정입니다:
1. 상업적 진전: FDA 승인을 받은 약물 전달 장치인 RenovoCath®에 대한 논의로, 새로운 구매 주문, 암 센터로부터의 재주문 및 초기 수익 창출에 대한 업데이트가 포함됩니다.
2. 임상 개발: 진행 중인 3상 TIGeR-PaC 임상 시험에 대한 업데이트로, 이는 그들의 주요 약물-장치 조합 후보 제품(IAG)을 평가합니다. 이 후보는 RenovoCath를 통해 자사의 독점적인 Trans-Arterial Micro-Perfusion (TAMP™) 플랫폼을 사용하여 국소 진행성 췌장암(LAPC) 치료를 위한 intra-arterial gemcitabine 전달을 결합합니다.
RenovoRx (Nasdaq: RNXT) a annoncé une discussion stratégique prévue pour le 3 avril 2025 à 12h00 ET, où le PDG Shaun Bagai fournira des mises à jour clés sur deux fronts principaux :
1. Progrès Commercial : Discussion sur RenovoCath®, leur dispositif de délivrance de médicaments approuvé par la FDA, y compris des mises à jour sur de nouvelles commandes d'achat, des réapprovisionnements de centres de cancérologie et la génération initiale de revenus.
2. Développement Clinique : Mises à jour sur l'essai clinique de Phase III TIGeR-PaC en cours, qui évalue leur principal candidat produit combiné médicament-dispositif (IAG). Ce candidat combine la délivrance intra-artérielle de gemcitabine via RenovoCath en utilisant leur plateforme propriétaire Trans-Arterial Micro-Perfusion (TAMP™) pour le traitement du cancer du pancréas localement avancé (LAPC).
RenovoRx (Nasdaq: RNXT) kündigte ein strategisches Gespräch an, das für den 3. April 2025 um 12:00 Uhr ET geplant ist, in dem CEO Shaun Bagai wichtige Updates zu zwei Hauptbereichen geben wird:
1. Kommerzielle Fortschritte: Diskussion über RenovoCath®, ihr von der FDA genehmigtes Medikamentenabgabegerät, einschließlich Updates zu neuen Bestellungen, Nachbestellungen von Krebszentren und ersten Einnahmen.
2. Klinische Entwicklung: Updates zur laufenden Phase-III-TIGeR-PaC-Studie, die ihr führendes Produktkandidatenkombination aus Medikament und Gerät (IAG) bewertet. Dieser Kandidat kombiniert die intra-arterielle Abgabe von Gemcitabin über RenovoCath unter Verwendung ihrer proprietären Trans-Arterial Micro-Perfusion (TAMP™) Plattform zur Behandlung von lokal fortgeschrittenem Pankreaskrebs (LAPC).
- FDA-cleared RenovoCath device generating initial revenues
- Receiving new purchase orders and reorders from cancer centers
- Ongoing progress in Phase III clinical trial for pancreatic cancer treatment
- Lead product candidate (IAG) still not approved for commercial sale
Shaun Bagai to discuss the momentum of RenovoRx’s commercialization efforts for its RenovoCath® device, including an update on initial revenues generated, and continued progress on the ongoing Phase III TIGeR-PaC clinical trial
Mr. Bagai will discuss RenovoRx’s continued momentum of its RenovoCath commercial efforts, including new purchase orders and reorders received from cancer center customers, and the realization of initial revenues.
Mr. Bagai will also discuss progress on RenovoRx’s ongoing Phase III TIGeR-PaC clinical trial. TIGeR-PaC is evaluating the Company’s lead drug-device combination product candidate (intra-arterial delivery of gemcitabine via the RenovoCath catheter), known as IAG which uses the proprietary Trans-Arterial Micro-Perfusion (TAMP™) therapy platform for the treatment of locally advanced pancreatic cancer (LAPC). The combination product candidate (IAG), which is enabled by the FDA-cleared RenovoCath device, is currently under investigation and has not been approved for commercial sale.
Fireside Chat Details:
Date: Thursday, April 3, 2025
Time: 12:00 p.m. ET
Webcast: https://ir.renovorx.com/news-events/ir-calendar-events
A question and answer session will occur at the end of the call, and a link to the recording of this presentation will be available on RenovoRx’s Investor Relations website after the event.
About RenovoCath
Based on its FDA clearance, RenovoCath® is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use (“IFU”), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.
About the TIGeR-PaC Clinical Trial
TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of LAPC. RenovoRx’s first investigational drug-device combination product candidate (intra-arterial delivery of gemcitabine via RenovoCath, known as IAG) using the TAMP therapy platform enabled with the Company’s FDA-cleared RenovoCath® device for the intra-arterial administration of chemotherapy, gemcitabine.
The first interim analysis in the Phase III clinical trial was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The TIGeR-PaC study is investigating TAMP in LAPC. The study’s primary endpoint is an overall survival benefit with secondary endpoints including reduced side effects versus standard of care. The second interim analysis for this study will be triggered by the 52nd event (i.e., patient death), which is estimated to occur in the second quarter of 2025. The second interim data readout would follow thereafter, with the timing for such readout depending on customary factors such as time needed for analysis. RenovoRx is also aiming to complete patient enrollment in the TIGeR-PaC study in mid-2025.
About RenovoRx, Inc.
RenovoRx (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel,
In addition to the RenovoCath device, RenovoRx is also evaluating our novel Phase III drug-device combination oncology product candidate (intra-arterial gemcitabine, known as IAG). IAG is being evaluated under a
IAG by the RenovoCath catheter is currently under investigation and has not been approved for commercial sale. RenovoCath with gemcitabine received Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon new drug application approval by the FDA.
RenovoRx is also engaged in implementing commercialization strategies utilizing its TAMP technology and FDA-cleared RenovoCath device as stand-alone device. In December 2024, RenovoRx announced the receipt of its first commercial purchase orders for RenovoCath devices. Additionally, certain of these customers have already initiated repeat orders as RenovoRx works to expand the number medical institutions that have initiated the process for RenovoCath purchase orders, including several esteemed, high volume National Cancer Institute-designated centers. To meet and satisfy the anticipated demand, RenovoRx will continue to actively explore further revenue-generating activity either on its own or in tandem with a medical device commercial partner.
For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X.
Cautionary Note Regarding Forward-Looking Statements
This press release, the fireside chat referred to herein, and statements of the Company’s management made in connection therewith contain 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 (i) our pre-clinical and clinical trials and studies, including the overall timing and timing for additional interim data readouts for our ongoing TIGeR-PaC Phase III clinical trial study in LAPC, (ii) the potential of RenovoCath® or TAMP™ as standalone commercial products, our anticipated timing for revenue generation from RenovoCath sales, and our commercialization plans in general, (iii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases and (iv) our efforts to explore commercialization strategies utilizing our TAMP technology. 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, commercial plans, intellectual property development, clinical trials, our therapy platform, business plans, financing plans, objectives and expected operating results, which are based on current expectations and assumptions that are subject to significant known and unknown risks and uncertainties that may cause actual results to differ materially and adversely 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: (i) the risk that our execution of our commercial strategy for RenovoCath or our TAMP technology may not lead to viable or repeating revenue generating operations; (ii) circumstances which would adversely impact our ability to efficiently utilize our cash resources on hand or raise additional funding, (iii) the timing of the initiation, progress and potential results (including the results of interim analyses) of TIGeR-PaC and any other preclinical studies, clinical trials and our research programs; (iv) the possibility that interim results may not be predictive of the outcome of our clinical trials, which may not demonstrate sufficient safety and efficacy to support regulatory approval of our product candidate, (v) that the applicable regulatory authorities may disagree with our interpretation of the data; research and clinical development plans and timelines, and the regulatory process for our product candidates; (vi) future potential regulatory milestones for our product candidates, including those related to current and planned clinical studies; (vii) our ability to use and expand our therapy platform to build a pipeline of product candidates; (viii) our ability to advance product candidates into, and successfully complete, clinical trials; (ix) the timing or likelihood of regulatory filings and approvals; (x) 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; (xi) the commercialization potential of our product candidates, if approved; (xii) our ability and the potential to successfully manufacture and supply our product candidates for clinical trials and for commercial use, if approved; (xiii) future strategic arrangements and/or collaborations and the potential benefits of such arrangements; (xiv) our estimates regarding expenses, future revenue, capital requirements and needs for additional financing and our ability to obtain additional capital; (xv) the sufficiency of our existing cash and cash equivalents to fund our future operating expenses and capital expenditure requirements; (xvi) our ability to retain the continued service of our key personnel and to identify, and hire and retain additional qualified personnel; (xvii) the implementation of our strategic plans for our business and product candidates; (xviii) the scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates and research programs; (xix) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xx) the pricing, coverage and reimbursement of our product candidates, if approved; and (xxi) developments relating to our competitors and our industry, including competing product candidates and therapies. 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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KCSA Strategic Communications
Valter Pinto or Jack Perkins
T: 212-896-1254
RenovoRX@KCSA.com
Source: RenovoRx, Inc.