AI Analysis | Feedback

Intuitive Surgical for targeted chemotherapy delivery

Varian Medical Systems for targeted chemotherapy delivery systems

AI Analysis | Feedback

• RenovoT1 (TAMPTM) Therapy System: A proprietary drug-device combination that utilizes the Trans-Arterial Micro-Perfusion (TAMPTM) platform to deliver chemotherapy, specifically RenovoGem (gemcitabine), directly to solid tumors, currently in clinical trials for locally advanced pancreatic cancer.

AI Analysis | Feedback

RenovoRx (RNXT) is a clinical-stage biopharmaceutical company focused on developing innovative therapies for difficult-to-treat solid tumors, primarily using its proprietary RenovoTrak™ (previously RenovoGEM™) drug-device platform for targeted drug delivery.

Based on the company's latest financial reports, including its Form 10-K for the fiscal year ended December 31, 2023, RenovoRx has not yet generated any revenue from the commercial sale of its product candidates. As a clinical-stage company, its current focus is on ongoing clinical trials, product development, and seeking regulatory approvals for its investigational therapies.

Therefore, RenovoRx does not currently have major commercial customers—neither other companies nor individual consumers—purchasing its products or services.

AI Analysis | Feedback

• CMIC Pharmaceutical Corporation
• Curia (private company)

AI Analysis | Feedback

Shaun R. Bagai, Chief Executive Officer

Mr. Bagai has served as RenovoRx's Chief Executive Officer and director since June 2014. Before joining RenovoRx, he led Global Market Development for HeartFlow, Inc. from 2011 to 2014, overseeing Japanese market research, regulatory/payer collaboration, and Key Opinion Leader development. He was also instrumental in developing the European market for renal denervation, a role that led to the acquisition of Ardian, Inc. by Medtronic in 2011. Mr. Bagai made an early career decision to forgo medical school, choosing instead to pursue the development of innovative therapies within the medical device industry, believing it would allow him to make a broader impact on healthcare.

James Ahlers, Chief Financial Officer

Mr. Ahlers was appointed Chief Financial Officer of RenovoRx effective July 15, 2022. He is an accomplished finance leader with over 25 years of experience building both public and private life science businesses. His previous roles include serving as CFO of Intarcia Therapeutics, Inc. and holding senior finance positions at Titan Pharmaceuticals, Inc. and Ansan Pharmaceuticals Inc. Throughout his career, Mr. Ahlers has managed capital raising transactions, including IPOs, which have collectively raised more than $2 billion. He has also provided consulting CFO and finance advisory services through Danforth Advisors, LLC, and continues this arrangement in his role at RenovoRx.

Ramtin Agah, MD, Chief Medical Officer, Co-Founder, and Chairman of the Board

Dr. Agah has served as RenovoRx's Chief Medical Officer and Co-Founder since December 2009, and as Chairman of the Board since May 2018. He is currently an Interventional Cardiologist at El Camino Hospital, Mountain View, a position he has held since September 2005. Dr. Agah has also worked as a physician consultant for Abbott Vascular since July 2012. Prior to this, he was an Assistant Professor of Internal Medicine with the Division of Cardiology at the University of Utah. RenovoRx was founded by Dr. Agah and Kamran Najmabadi in 2009.

Leesa Gentry, Chief Clinical Officer

Ms. Gentry was promoted to Chief Clinical Officer on March 8, 2024. Before joining RenovoRx, she held the position of Senior Vice President of Clinical Operations at Evotec (NASDAQ: EVO). At PPD, she was a Global Project Manager and Senior Research Specialist for Clinical Systems, where her team developed one of the pharmaceutical industry's first clinical trial management systems. Ms. Gentry's experience also includes growing the clinical research site network within long-term care at Omnicare and developing novel methods for streamlined trial implementation at Otsuka.

Ronald B. Kocak, CPA, Vice President, Controller and Principal Accounting Officer

Mr. Kocak was promoted to Principal Accounting Officer and maintains his roles as Vice President and Controller as of March 8, 2024. He joined RenovoRx in October 2021, initially serving as an interim controller in a consulting capacity. Mr. Kocak is a seasoned financial reporting and accounting professional with extensive public and private company experience in the life sciences industry. Prior to his time at RenovoRx, he was the Controller and Senior Director of Finance at Sensei Biotherapeutics, Inc., where he successfully managed the finance and accounting activities, including IT operations. He played a key role in the recent completion of a $6.1 million private placement for RenovoRx.

AI Analysis | Feedback

Key Risks to RenovoRx (RNXT)

1. Clinical Trial Uncertainty and Regulatory Risks
   The success of RenovoRx's core Trans-Arterial Micro-Perfusion (TAMP™) platform and its lead product, RenovoCath combined with gemcitabine, is highly dependent on the successful completion of its pivotal Phase III TIGeR-PaC clinical trial and subsequent regulatory approvals. While early results have shown promise, any delays, inconclusive outcomes, or safety concerns from the ongoing trial could significantly undermine the platform's viability, delay or prevent regulatory approval, and negatively impact future revenue and investor confidence. The company's dependence on this single flagship trial exposes it to substantial clinical and regulatory risk over an extended period, with final data anticipated in 2027.
2. Financial Challenges and Need for Additional Funding
   As a development-stage company, RenovoRx has consistently reported net losses and limited revenue. Its operating margin and net margin are significantly negative, and the Altman Z-Score indicates financial distress, suggesting a potential risk of bankruptcy. To fund its ongoing operations, research and development, clinical trials, and commercialization efforts, RenovoRx will likely require substantial additional capital. This need for future equity or debt financing could lead to dilution for existing shareholders, put pressure on earnings per share and net margins, and impact the share price.
3. Market Competition and Commercial Adoption Challenges
   The oncology market, particularly for pancreatic cancer, is highly competitive, with numerous companies developing both systemic and targeted therapies. Even with regulatory approval, RenovoRx's ability to achieve widespread commercial adoption of its RenovoCath device and TAMP™ platform is a significant challenge. The company has shown initial commercial traction, but its revenue remains relatively low, and scaling up sales and marketing in a crowded market to achieve significant revenue growth and market penetration is critical. The early commercial model's reliance on a lean sales force and physician-to-physician advocacy also presents risks to efficient scaling.

AI Analysis | Feedback

null

AI Analysis | Feedback

RenovoRx (RNXT) has identified the following addressable markets for its main products and services:

• RenovoCath (as a stand-alone device): The initial total addressable market (TAM) is estimated to be a $400 million peak annual U.S. sales opportunity. RenovoRx anticipates that expanding into additional applications could lead to a total addressable market of several billion dollars. This market size is for the U.S. region.
• RenovoTAMP platform/RenovoGem (for pancreatic cancer): RenovoRx is targeting a $1 billion global market opportunity for pancreatic cancer alone.
• RenovoGem/TAMP platform (for cholangiocarcinoma): The global cholangiocarcinoma market was valued at USD 583.65 million in 2025 and is projected to reach USD 2.42 billion by 2035, with North America expected to hold approximately 35% of the market share by 2035. Over 7,000 new cases of cholangiocarcinoma are diagnosed annually in the U.S.

AI Analysis | Feedback

1. Increased Commercial Sales and Customer Base Expansion of RenovoCath: RenovoRx commenced commercial sales of its FDA-cleared RenovoCath device in late 2024, with Q1 and Q2 2025 showing sequential quarterly revenue growth. The company reported over $400,000 in commercial revenue for Q2 2025, driven by new customer purchase orders and early repeat orders from initial sites. RenovoRx has expanded its customer base to thirteen cancer centers and anticipates continued growth by onboarding more centers and deepening use among approved customers. The company projects an initial total addressable market (TAM) for RenovoCath as a standalone device to be an estimated $400 million in peak annual U.S. sales.
2. Strategic Expansion of Sales Team: To enhance market penetration and capitalize on the growing demand for RenovoCath, RenovoRx plans to strategically expand its sales team in the second half of 2025, with revenue growth projected to pick up in 2026 as a direct result of these commercialization efforts.
3. Successful Completion and Regulatory Approval of the TIGeR-PaC Clinical Trial: The ongoing pivotal Phase III TIGeR-PaC clinical trial for locally advanced pancreatic cancer (LAPC), investigating RenovoGem (RenovoCath plus gemcitabine), is a critical driver. The company plans to complete enrollment by early 2026, with hopes for accelerated FDA approval. Positive interim data reviews have led to recommendations to continue the trial, and many of the 18 cancer centers participating in the trial are identified as potential future customers after enrollment completion.
4. Expansion into New Tumor Indications: Beyond pancreatic cancer, RenovoRx's Trans-Arterial Micro-Perfusion (TAMP™) therapy platform and the RenovoCath device are being explored for use in other solid tumors, such as bile duct cancer (cholangiocarcinoma). This expansion into additional applications beyond the initial focus on LAPC could unlock a several-billion-dollar total addressable market and significantly contribute to future revenue growth.

AI Analysis | Feedback

Share Issuance

• In February 2025, RenovoRx closed a $12.1 million underwritten public offering of common stock, selling approximately 11.52 million shares at $1.05 per share, resulting in net proceeds of about $10.9 million.
• In April 2024, the company executed a private placement that was expected to raise approximately $11.1 million, involving the issuance of common stock and warrants.
• Earlier in January 2024, RenovoRx completed a private placement that generated gross proceeds of approximately $6.1 million, with participation from insiders.

Inbound Investments

• RenovoRx successfully raised $17.2 million in total gross proceeds from private placements in January and April 2024.
• In February 2025, the company closed an underwritten public offering, raising approximately $12.1 million in gross proceeds, primarily from new fundamental healthcare institutional investors.
• These investments are crucial for funding operations, advancing the pivotal Phase III TIGeR-PaC clinical trial, and expanding the TAMP clinical development pipeline into additional cancer indications.

Capital Expenditures

• Capital expenditures for RenovoRx have been minimal, with a trailing twelve-month figure ending June 2025 reported as approximately $-0.00 million.
• For the last 12 months, capital expenditures amounted to -$14,000.
• Funding from recent capital raises is intended to cover operating expenses and capital expenditure requirements, primarily supporting the ongoing Phase III TIGeR-PaC clinical trial and the commercialization efforts of the RenovoCath device.