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RenovoRx Reports Initial Revenues from RenovoCath® Commercialization, and Provides Update on Ongoing Pivotal Phase III TIGeR-PaC Clinical Trial

On April 1, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared drug-delivery device, reported its financial results and business updates for the fourth quarter and full year ended December 31, 2024 (Press release, Renovorx, APR 1, 2025, View Source [SID1234651735]).

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"The fourth quarter of 2024 marks a significant milestone in our company history as we have generated our first revenue from sales of our proprietary RenovoCath device on a standalone basis, with expectations for meaningful revenue growth going forward. Importantly, we believe our current commercial strategy can be accomplished without a material increase in our capital expenditures, regardless of whether we self-commercialize or choose to partner with a larger organization and use their existing sales force and channels. Further, we believe that the gross proceeds from our February 2025 public offering of $12.1 million together with our cash on hand of $7.2 million at year end fully funds our current operational plan as we look to scale RenovoCath revenues and progress our Phase III TIGeR-PaC clinical trial towards key milestones. Moreover, we expect that growing RenovoCath revenues will reduce our burn rate as we prudently deploy our cash on hand to drive shareholder value," said Shaun Bagai, CEO of RenovoRx.

"Based on our internal analysis with current clinical applications, we believe that our initial total addressable market (TAM) for RenovoCath represents an estimated $400 million peak annual U.S. sales opportunity. Beyond this, there are expansion opportunities across other indications that could create the potential for a several billion-dollar U.S. TAM for RenovoCath over time," continued Mr. Bagai. "We expect revenue to increase to the low six figure range for the first quarter of 2025 followed by sequential quarter-over-quarter increases for the remainder of the year."

RenovoCath Commercialization Update

In December 2024, RenovoRx received first commercial purchase orders for its RenovoCath device, which resulted in revenue generation of approximately $43,000 for the fourth quarter of 2024.

RenovoRx is seeing strong organic demand for RenovoCath. More than ten medical institutions have initiated the process for RenovoCath purchase orders, and purchase orders have already been received from several esteemed, high volume National Cancer Institute-designated centers. Additionally, utilization of RenovoCath devices by initial customers has led to repeat purchase orders. Moreover, RenovoRx believes the twenty cancer centers that have used RenovoCath as part of its TIGeR-PaC trial could also be potential customers for RenovoCath after completion of TIGeR-PaC enrollment later this year.

RenovoRx has identified its initial target market for RenovoCath to be approximately $400 million in peak annual U.S. sales, based on the Company’s internal assumptions1. Moreover, expansion opportunities across other clinical indications could create a several billion-dollar total addressable market potential for RenovoCath over time. It’s management’s belief that the Company can achieve meaningful market penetration with a small commercial team targeting the top 200 high-volume treatment centers.

Importantly, there is a current reimbursement code with the Centers for Medicare and Medicaid Services covering procedures utilizing specialty pressure-mediated delivery catheters, which creates incentives for hospitals to adopt more advanced technology, like RenovoCath.

Ongoing Pivotal Phase III TIGeR-PaC Clinical Trial Update

During the fourth quarter 2024, RenovoRx added several additional renowned clinical oncology sites to participate in the TIGeR-PaC study. The initiation of these sites allows for new patient enrollment at the Sarah Cannon Research Institute Oncology Partners in Nashville, TN and at the Northwell Health Cancer Institute Clinical Site in New Hyde Park, NY which are key additions to the number of clinical sites to support RenovoRx’s path to completing patient enrollment for the trial. RenovoRx is continuing to target additional clinical oncology sites, with the expectation that the study will achieve full enrollment during 2025.

The current protocol and statistical analysis plan for the TIGeR-PaC trial requires 114 randomized patients, with 86 events (deaths) necessary to complete the final analysis. As of March 28, 2025, 90 patients have been randomized with 50 events having occurred. A second interim analysis will be triggered by the 52nd event.

The timing required to analyze the data after the 52nd event is expected to take several months and includes a full review with recommendations by the TIGeR-PaC Data Monitoring Committee. RenovoRx currently anticipates the 52nd event to occur during the second quarter of 2025. The key recommendation from the Data Monitoring Committee on whether or not to continue the study based on the data reviewed is expected to be announced in the second half of 2025.

Fireside Chat Strategic Update

RenovoRx will host a fireside chat with Shaun Bagai, Chief Executive Officer, on Thursday, April 3, 2025, at 12:00 p.m. ET. During the event, Mr. Bagai will 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. Additionally, one of RenovoCath’s initial customers, Gregory Tiesi, MD, FACS, FSSO, Medical Director of Hepatobiliary Surgery, Division of Surgical Oncology, Hackensack Meridian Jersey Shore University Medical Center, will join Mr. Bagai. He will share his insights on the Trans-Arterial Micro-Perfusion (TAMP) therapy platform and its impact on patient care. Hackensack Meridian Jersey Shore University Medical Center began using the RenovoCath device with oncology patients in December 2024.

Fireside Chat Details:
Date: Thursday, April 3, 2025
Time: 12:00 p.m. ET
Webcast: View Source

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.

Hengrui’s Camrelizumab Combo Therapy Doubles the Five -Year Survival of Patients with Advanced Squamous Lung Cancer – A Potential Paradigm Shift in Clinical Outcome for this Difficult-to Treat Population

On April 1, 2025 Hengrui Pharmaceuticals reported the 5-year long-term follow-up data from the CameL-sq study-a randomized, double-blind, multicenter, phase III trial that evaluated the efficacy and safety of camrelizumab vs. placebo in combination with carboplatin and paclitaxel as first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) with negative driver genes (Press release, Hengrui Pharmaceuticals, APR 1, 2025, View Source;year-survival-of-patients-with-advanced-squamous-lung-cancer—a-potential–paradigm-shift-in-clinical-outcome-for-this-difficult-to-treat-population-302416809.html [SID1234651734]). The results show that the 5-year overall survival (OS) rate for patients treated with camrelizumab plus chemotherapy was 27.8%, indicating that more than one-quarter of the patients survived beyond five years., and a 15.3% improvement over the placebo-chemotherapy group (12.5%). Additionally, camrelizumab significantly reduced the risk of mortality by 43%, enabling more patients to achieve long-term survival.

The five-year survival rate serves as a critical indicator for assessing potential clinical cure in oncology. China’s Healthy China 2030 initiative has established an ambitious target to increase the overall five-year survival rate for cancer patients by 15%. Epidemiologic data from the National Cancer Center consistently identify lung cancer as the malignancy with the highest incidence and mortality rates across both genders. However, early symptoms of lung cancer are frequently overlooked, resulting in most patients being diagnosed at an advanced stage. In the era dominated by traditional chemotherapy, the five-year survival rate for patients with advanced lung cancer was below 10%. Among histologic subtypes, squamous NSCLC presents unique challenges as it does not benefit from targeted therapies, leading to relatively poor survival outcomes. With the advent of immunotherapy drugs, the prognosis for squamous NSCLC has significantly improved; however, numerous unmet clinical needs remain.

Camrelizumab is a humanized IgG4 monoclonal antibody independently developed by Hengrui Pharmaceuticals. With high binding affinity to PD-1, it has been shown to significantly improve the overall survival of patients with various solid tumors, including lung cancer, liver cancer, esophageal cancer, and nasopharyngeal cancer. At the 2024 ELCC, the long-term follow-up data from the CameL study were presented, highlighting the efficacy of camrelizumab in combination with chemotherapy as a first-line treatment for advanced non-squamous non-small cell lung cancer. The findings revealed that approximately one-third of the patients achieved a survival duration exceeding five years.

The significant clinical benefits of camrelizumab plus chemotherapy as demonstrated by the CameL-sq study ( an increase of 15.3% in the five year survival rate compared to the control group), represent a meaningful advancement toward the goals outlined in the Healthy China 2030 blueprint for cancer prevention and control. This breakthrough represents another significant contribution from Hengrui Pharmaceuticals, a leading innovator in China’s pharmaceutical sector, to prolong and improve the lives of cancer patients worldwide.

Dizal Announces DZD8586 and DZD6008 Presentations at 2025 ASCO Annual Meeting

On April 1, 2025 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that results of its investigational drug candidates DZD8586 and DZD6008, have been selected for presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30 – June 3, 2025, in Chicago (Press release, Dizal Pharma, APR 1, 2025, View Source [SID1234651733]).

Oral and poster presentations of its DZD8586 study results in chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma (DLBCL) are selected by ASCO (Free ASCO Whitepaper) Scientific Program Committee. In addition, Dizal will present its 4th generation EGFR TKI clinical data in non-small cell lung cancer (NSCLC) during the conference.

About DZD8586

DZD8586 is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed as a potential treatment option for B-cell non-Hodgkin lymphoma (B-NHL).

While Bruton’s Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can arise through two major mechanisms: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Currently, there is no targeted therapy available to address both resistance mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging efficacy in early clinical studies, mutation-related resistance has been reported, and degrader-related toxicities may affect long-term clinical application.

DZD8586 has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-NHLs in cell lines and in animal models. Phase I clinical trial suggests that DZD8586 exhibits favorable PK properties, good central nervous system (CNS) permeability, complete blockade of BCR signaling, and encouraging anti-tumor efficacy with good safety and tolerability in patients with B-NHL.

About DZD6008

DZD6008, is a novel, highly selective, full-BBB penetrant EGFR TKI, designed as a potential treatment option for advanced EGFR mutation positive (EGFRm) NSCLC.

Non-small cell lung cancer is the leading cause of cancer death in the world. Epidermal growth factor receptor (EGFR) gene is one of the most common driver genes for NSCLC. Multiple agents can be used to treat patients with EGFR mutated NSCLC who develop resistance to EGFR tyrosine kinase inhibitors (TKIs), but the clinical outcome was not satisfactory. Brain metastases (BM) are a leading cause of death and disease progression for NSCLC. Approximately 23%-30% of NSCLC patients are synchronous BM at their initial diagnosis. Previous studies reported that the 3-year cumulative rate of BMs ranges from 29.4% to 60.3% in patients with mutated EGFR.

Currently, the clinical benefits of existing treatments for third-generation EGFR TKI-resistant NSCLC are limited and DZD6008 is expected to fill the unmet medical needs. DZD6008 effectively inhibits EGFR-mutated tumor growth in cell lines and in animal models. Previous clinical studies have validated the design concept of the molecule and suggest that DZD6008 demonstrates good safety and efficacy in NSCLC patients with brain metastases who had failed third-generation EGFR TKI therapy or multiple lines of pre-treatments.

Nuvalent to Participate in the Stifel 2025 Virtual Targeted Oncology Forum

On April 1, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participate in a fireside chat during the Stifel 2025 Virtual Targeted Oncology Forum on Tuesday, April 8, 2025, at 2:30 p.m. ET (Press release, Nuvalent, APR 1, 2025, View Source [SID1234651732]).

A live webcast will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentations.

Citius Pharmaceuticals Announces $2 Million Registered Direct Offering of Common Stock

On April 1, 2025 Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported that it has entered into a definitive agreement for the purchase of 1,739,131 shares of its common stock (or pre-funded warrants in lieu thereof), at a purchase price of $1.15 per share (or pre-funded warrant in lieu thereof) (Press release, Citius Pharmaceuticals, APR 1, 2025, View Source [SID1234651731]). The closing of the offering is expected to occur on or about April 2, 2025, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering are expected to be approximately $2 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering to support the commercial launch of LYMPHIR as well as general corporate purposes.

The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-277319) filed with the Securities and Exchange Commission ("SEC") on February 23, 2024 and declared effective on March 1, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.