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RNXT

RenovoRxD
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-13
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Earnings documents stored for RNXT.

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Investor releaseQuarter not tagged2026-08-13

RenovoRx, Inc. Q2 2026 Earnings Call Summary

Moby
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved record quarterly revenue of $909 thousand, representing approximately 83% of the entire full-year 2025 revenue, driven by a compounding effect of new center activations and repeat orders. Expanded the clinical utility of the RenovaCath device beyond the core focus of pancreatic cancer with the first physician-driven commercial use in sarcoma treatment. Transitioned the corporate narrative from clinical concept to commercial execution, utilizing a lean sales team to focus on high-touch engagement with interventional radiologists. Attributed revenue growth to a 30% sequential increase in active commercial cancer centers, which serve as recurring sources of repeat demand. Positioned the TAMP technology as a collaborative drug delivery platform that complements, rather than competes with, emerging novel systemic therapies for solid tumors. Maintained high gross margins of approximately 84%, reflecting strong underlying economics as the business scales toward operational breakeven. Raised and tightened full-year 2026 revenue guidance to $3.75 million–$4.25 million, implying year-over-year growth of 241% to 286%. Anticipates achieving cash flow breakeven in the fourth quarter of 2027, predicated on reaching a quarterly revenue run rate of approximately $5 million. Expects the 15 Phase III TIGeR-PaC trial sites to become meaningful revenue contributors in the second half of 2026 as they transition to commercial use. Projects top-line data for the Phase III TIGeR-PaC trial to be available in the back half of 2027 following the observation of 86 total events. Plans to introduce a next-generation product in 2027 which management believes will allow for further expansion of gross margins. Identified 'new account activations' as the primary leading indicator for future revenue growth, with 42 additional centers currently in the evaluation pipeline. Noted that while the current cash position of $9.5 million provides runway into the second half of 2027, the company may be opportunistic regarding capital markets if conditions are favorable. Highlighted that the TIGeR-PaC trial is now fully enrolled, shifting management focus from recruitment to final data analysis and event monitoring. Emphasized that the transiti…Read full document

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved record quarterly revenue of $909 thousand, representing approximately 83% of the entire full-year 2025 revenue, driven by a compounding effect of new center activations and repeat orders. Expanded the clinical utility of the RenovaCath device beyond the core focus of pancreatic cancer with the first physician-driven commercial use in sarcoma treatment. Transitioned the corporate narrative from clinical concept to commercial execution, utilizing a lean sales team to focus on high-touch engagement with interventional radiologists. Attributed revenue growth to a 30% sequential increase in active commercial cancer centers, which serve as recurring sources of repeat demand. Positioned the TAMP technology as a collaborative drug delivery platform that complements, rather than competes with, emerging novel systemic therapies for solid tumors. Maintained high gross margins of approximately 84%, reflecting strong underlying economics as the business scales toward operational breakeven. Raised and tightened full-year 2026 revenue guidance to $3.75 million–$4.25 million, implying year-over-year growth of 241% to 286%. Anticipates achieving cash flow breakeven in the fourth quarter of 2027, predicated on reaching a quarterly revenue run rate of approximately $5 million. Expects the 15 Phase III TIGeR-PaC trial sites to become meaningful revenue contributors in the second half of 2026 as they transition to commercial use. Projects top-line data for the Phase III TIGeR-PaC trial to be available in the back half of 2027 following the observation of 86 total events. Plans to introduce a next-generation product in 2027 which management believes will allow for further expansion of gross margins. Identified 'new account activations' as the primary leading indicator for future revenue growth, with 42 additional centers currently in the evaluation pipeline. Noted that while the current cash position of $9.5 million provides runway into the second half of 2027, the company may be opportunistic regarding capital markets if conditions are favorable. Highlighted that the TIGeR-PaC trial is now fully enrolled, shifting management focus from recruitment to final data analysis and event monitoring. Emphasized that the transition from experimental procedure to standard of care is being supported by an increasing volume of peer-reviewed case studies and scientific publications. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management explained that a physician comfortable with the device in pancreatic cases identified a difficult-to-reach sarcoma where isolating flow was critical for drug penetration. The expansion is viewed as a sign of broader adoption, as interventional radiologists are 'inventive' and likely to apply the technology across various solid tumors. The company discovered that the sales cycle requires navigating complex hospital back-office approvals and ensuring strong communication between radiologists and referring physicians. Management opted for a small, dedicated internal field force over a partnership to maintain the high-touch engagement necessary for early-stage market development. While enrollment is closed, randomization is nearing completion with only a handful of patients left to reach the 114-patient target with a 'handful' of patients remaining. The study remained open slightly longer than anticipated to create a buffer of patients in the induction phase to account for potential dropouts. The current 21 active sites represent a mix of high-volume centers and smaller community hospitals; management has not yet fully penetrated the highest-volume locations. The top 10 advanced cancer centers represent about 25% of the total market, providing significant untapped revenue opportunity as the pipeline converts.

Investor releaseQuarter not tagged2026-08-13

RenovoRx Q2 Earnings Call Highlights

MarketBeat
Interested in RenovoRx, Inc.? Here are five stocks we like better. Record commercial growth: Second-quarter revenue rose 115% year over year to $909,000, supported by increased RenovoCath procedures, repeat orders and expansion to 21 active cancer centers. RenovoRx raised and narrowed its 2026 revenue outlook to $3.75 million–$4.25 million. Pancreatic cancer trial advances: The company completed enrollment in its Phase III TIGeR-PaC trial, with final events expected in the first half of 2027 and initial top-line results anticipated in the second half of 2027. Broader clinical applications: RenovoCath was used commercially for the first time in a sarcoma case, while RenovoRx also began supporting an investigator-initiated study in bile duct cancer, expanding its potential beyond pancreatic cancer. RenovoRx (NASDAQ:RNXT) reported record second-quarter revenue as it expanded its commercial cancer-center network and advanced its clinical program for locally advanced pancreatic cancer. For the quarter ended June 30, 2026, the company generated revenue of $909,000, up approximately 61% from $563,000 in the first quarter and 115% from $422,000 a year earlier. Chief Executive Officer Shaun Bagai said second-quarter revenue represented roughly 83% of the company’s full-year 2025 revenue of $1.1 million. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat Bagai attributed the growth to a rising number of active commercial cancer centers, procedures and repeat orders for RenovoCath, the company’s catheter device used with its Trans-Arterial Micro-Perfusion, or TAMP, drug-delivery technology. RenovoRx ended the second quarter with 21 active commercial cancer centers, compared with 16 as of its May 14 earnings call. The company defines active centers as sites that have purchased a catheter and treated a patient, Bagai said during the question-and-answer session. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be The company is targeting at least 36 active commercial cancer centers by the end of 2026. In addition to its active customers, RenovoRx said 42 centers were in various stages of evaluation, approval and activation, bringing its total commercial funnel to 63 centers, up from 48 centers reported in the first quarter. Bagai said 15 sites participating in the company’s Phase III TIGeR-PaC clinical trial are positioned to transition t…Read full document

Interested in RenovoRx, Inc.? Here are five stocks we like better. Record commercial growth: Second-quarter revenue rose 115% year over year to $909,000, supported by increased RenovoCath procedures, repeat orders and expansion to 21 active cancer centers. RenovoRx raised and narrowed its 2026 revenue outlook to $3.75 million–$4.25 million. Pancreatic cancer trial advances: The company completed enrollment in its Phase III TIGeR-PaC trial, with final events expected in the first half of 2027 and initial top-line results anticipated in the second half of 2027. Broader clinical applications: RenovoCath was used commercially for the first time in a sarcoma case, while RenovoRx also began supporting an investigator-initiated study in bile duct cancer, expanding its potential beyond pancreatic cancer. RenovoRx (NASDAQ:RNXT) reported record second-quarter revenue as it expanded its commercial cancer-center network and advanced its clinical program for locally advanced pancreatic cancer. For the quarter ended June 30, 2026, the company generated revenue of $909,000, up approximately 61% from $563,000 in the first quarter and 115% from $422,000 a year earlier. Chief Executive Officer Shaun Bagai said second-quarter revenue represented roughly 83% of the company’s full-year 2025 revenue of $1.1 million. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat Bagai attributed the growth to a rising number of active commercial cancer centers, procedures and repeat orders for RenovoCath, the company’s catheter device used with its Trans-Arterial Micro-Perfusion, or TAMP, drug-delivery technology. RenovoRx ended the second quarter with 21 active commercial cancer centers, compared with 16 as of its May 14 earnings call. The company defines active centers as sites that have purchased a catheter and treated a patient, Bagai said during the question-and-answer session. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be The company is targeting at least 36 active commercial cancer centers by the end of 2026. In addition to its active customers, RenovoRx said 42 centers were in various stages of evaluation, approval and activation, bringing its total commercial funnel to 63 centers, up from 48 centers reported in the first quarter. Bagai said 15 sites participating in the company’s Phase III TIGeR-PaC clinical trial are positioned to transition to commercial RenovoCath use, with several already doing so. Some trial sites waited until enrollment was complete before beginning commercial activity, he said. → First Solar’s Profit Engine Faces a New Policy Test in Washington Management said repeat ordering from existing centers remains a key commercial indicator. Bagai said the company’s third-quarter revenue was tracking to exceed the second-quarter level, though the company did not provide a specific quarterly forecast. Chief Financial Officer Mark Voll said the company has used its initial commercial rollout to understand factors affecting site activation, including approvals, physician referrals and coordination among specialties. The company has maintained a small sales force rather than rapidly building a larger one, he said, with field representatives focused on communication and on-site engagement. Gross profit was $766,000 in the second quarter, producing a gross margin of approximately 84%, compared with roughly 85% in the first quarter. Research and development expense was about $1.2 million, while selling, general and administrative expense was approximately $2.9 million. Loss from operations totaled about $3.4 million, compared with an operating loss of $3.5 million in the prior quarter. Voll said that, excluding non-cash stock-based compensation, the operating loss improved by approximately $370,000 sequentially. Net loss per share was $0.06, versus $0.08 in the second quarter of 2025 and $0.09 in the first quarter of 2026. RenovoRx had approximately $9.5 million in cash and cash equivalents as of June 30, down from $12.4 million at March 31. Voll said management believes the company has sufficient cash runway into the second half of 2027, assuming revenue and active-site growth progress as anticipated. The company raised and narrowed its full-year 2026 revenue guidance to a range of $3.75 million to $4.25 million, from a prior range of $3 million to $4 million. The revised range implies year-over-year revenue growth of 241% to 286%, based on 2025 revenue of $1.1 million. Management said it believes a quarterly revenue run rate of approximately $5 million would position the company for cash-flow break-even. Based on its internal plan, RenovoRx expects to reach break-even operations in the fourth quarter of 2027. Chief Medical Officer, Executive Chair and Founder Dr. Ramtin Agah said RenovoRx has completed enrollment in its Phase III TIGeR-PaC trial evaluating intra-arterial gemcitabine delivered through the TAMP platform for locally advanced pancreatic cancer. The trial’s primary endpoint is overall survival. It is designed to compare the company’s targeted delivery approach with standard-of-care systemic intravenous gemcitabine plus ABRAXANE. Investigators were notified on Aug. 7 that enrollment was closing. As of Aug. 11, the study had recorded 78 events, and trial completion is expected in the first half of 2027 after 86 events have occurred. Initial top-line data is expected in the second half of 2027. During the Q&A session, Bagai said randomization was still being finalized and that the company was close to completing it, with a handful of patients remaining. He said the company had not publicly disclosed the exact number of patients randomized. RenovoRx also reported the first commercial clinical use of RenovoCath for sarcoma, representing the device’s use in a solid tumor outside of locally advanced pancreatic cancer. Agah said the case was initiated by a physician who had experience treating pancreatic cancer patients with RenovoCath and identified a difficult-to-reach sarcoma case where the device could be used to isolate blood flow and improve tumor penetration of the drug. Agah also highlighted several scientific updates during the quarter, including a peer-reviewed Moffitt Cancer Center case study published in Radiology Case Reports, as well as forthcoming publications related to the TIGeR-PaC pharmacokinetic sub-study and a case series from Hackensack Meridian Health Jersey Shore University Medical Center. The company additionally began supporting an investigator-initiated study in cholangiocarcinoma, or bile duct cancer, which is expected to begin soon. RenovoRx, Inc is a clinical-stage medical technology company focused on the development of proprietary drug-device combination therapies for the treatment of solid tumor malignancies. The company's lead product candidate, RenovoCath™, is an intra-arterial catheter system designed to deliver high concentrations of chemotherapeutic agents directly to tumor sites while minimizing systemic exposure. RenovoRx seeks to improve clinical outcomes and reduce adverse effects by enhancing drug delivery precision in hard-to-treat cancers. RenovoCath™ is being evaluated in multiple clinical trials targeting advanced pancreatic cancer and metastatic colorectal cancer, among other solid tumors. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "RenovoRx Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Investor releaseQuarter not tagged2026-08-13

RenovoRx Inc (RNXT) (Q2 2026) Earnings Call Highlights: Record Revenue and Strategic Expansion ...

GuruFocus.com
This article first appeared on GuruFocus. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Record Q2 2026 revenue of $909,000, up 61% sequentially and 115% year-over-year, with Q2 alone representing 83% of full-year 2025 revenue. Active commercial cancer centers increased 31% to 21, with a robust pipeline of 42 additional centers, supporting the target of 36 by year-end 2026. First commercial use of RenovoCath in sarcoma, demonstrating expansion beyond pancreatic cancer and physician-driven adoption. Phase 3 TIGERPAC trial achieved full enrollment, with top-line data expected in the back half of 2027, a key value driver. Strong gross margin of 84%, with management expecting further improvement from next-generation product, and a clear path to cash flow breakeven by Q4 2027. Cash position declined to $9.5 million from $12.4 million in Q1, with a burn rate that, while declining, still requires careful management. Operating loss remains significant at $3.4 million for the quarter, though improved from the prior quarter. The company is still far from profitability, with breakeven not expected until late 2027, and requires continued revenue scaling. Dependence on a small number of high-volume centers for a large portion of revenue, with many pipeline centers yet to convert to active users. The TIGERPAC trial's success is not guaranteed, and a negative readout could impact adoption and reimbursement, though the company is not a binary event. Warning! GuruFocus has detected 1 Warning Sign with RNXT. Is RNXT fairly valued? Test your thesis with our free DCF calculator. Q: Now that enrollment for the TIGERPAC study is closed, how many of the patients actually ended up randomized? Did the number fall above or below the full 114 patients?A: Sean Bhagat (CEO): We haven't yet completed randomization; it's still in process. We didn't report the exact number publicly, but we are very close, with only a handful of patients left. We intentionally kept the study open a bit longer than anticipated to allow physicians to enroll patients and have them in the induction phase, creating a buffer to ensure we can randomize the 114 patients without issue if there are dropouts. Q: What gives you confidence that you can reach the target of 36 active commercial centers by the end of the year, and how many…Read full document

This article first appeared on GuruFocus. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Record Q2 2026 revenue of $909,000, up 61% sequentially and 115% year-over-year, with Q2 alone representing 83% of full-year 2025 revenue. Active commercial cancer centers increased 31% to 21, with a robust pipeline of 42 additional centers, supporting the target of 36 by year-end 2026. First commercial use of RenovoCath in sarcoma, demonstrating expansion beyond pancreatic cancer and physician-driven adoption. Phase 3 TIGERPAC trial achieved full enrollment, with top-line data expected in the back half of 2027, a key value driver. Strong gross margin of 84%, with management expecting further improvement from next-generation product, and a clear path to cash flow breakeven by Q4 2027. Cash position declined to $9.5 million from $12.4 million in Q1, with a burn rate that, while declining, still requires careful management. Operating loss remains significant at $3.4 million for the quarter, though improved from the prior quarter. The company is still far from profitability, with breakeven not expected until late 2027, and requires continued revenue scaling. Dependence on a small number of high-volume centers for a large portion of revenue, with many pipeline centers yet to convert to active users. The TIGERPAC trial's success is not guaranteed, and a negative readout could impact adoption and reimbursement, though the company is not a binary event. Warning! GuruFocus has detected 1 Warning Sign with RNXT. Is RNXT fairly valued? Test your thesis with our free DCF calculator. Q: Now that enrollment for the TIGERPAC study is closed, how many of the patients actually ended up randomized? Did the number fall above or below the full 114 patients?A: Sean Bhagat (CEO): We haven't yet completed randomization; it's still in process. We didn't report the exact number publicly, but we are very close, with only a handful of patients left. We intentionally kept the study open a bit longer than anticipated to allow physicians to enroll patients and have them in the induction phase, creating a buffer to ensure we can randomize the 114 patients without issue if there are dropouts. Q: What gives you confidence that you can reach the target of 36 active commercial centers by the end of the year, and how many of these are from clinical trial conversions?A: Sean Bhagat (CEO): The 21 active centers were as of the end of the quarter, and we've activated more since then. Our confidence comes from having 42 additional centers in the pipeline, which is well over the 36 target. The bulk of the 15 TIGERPAC sites have not yet begun treating commercially, as a handful wanted to wait until enrollment was complete to avoid competing interests. We anticipate activating those over the next quarter or two, which should contribute meaningfully to revenue, alongside the other 40-plus centers in the customer pipeline. Q: On the clinical trial sites that become active commercial sites, what is the anticipated timeline from when they are activated to when they place their first order?A: Sean Bhagat (CEO): When we say "active," these are sites that have already purchased a catheter and treated a patient. We deliberately avoid counting sites that are merely ready to go or haven't purchased a device yet. The other 42 in the pipeline are at various stages, including being greenlit to order or having ordered but not yet treated their first patient. So, our definition of active is strictly purchasing and using customers. Q: As you scale up volume for RenovoCath, do you think your gross margins and operating margins can go higher?A: Mark Fall (CFO): Yes, we have the opportunity to increase gross margins when we introduce our next-generation product, which we expect to launch sometime next year. That should allow us to improve from our current gross margin level of approximately 84%. Q: Is there any difference in the volume or business potential of the additional centers in your pipeline compared to the first 21 you have already activated? Are they smaller or the same size?A: Sean Bhagat (CEO): The 21 active centers are a good representation of the full spectrum, including high-volume centers and smaller community-based hospitals. We haven't yet hit all the high-volume places, so there is significant opportunity for revenue growth. Mark Fall (CFO): The market is concentrated, with the top 10 advanced cancer centers representing about 25% of the market. While we target the larger ones, we are bringing a broad range of centers online, but securing the larger centers will provide the largest revenue opportunity. Q: Can you provide additional color on what prompted the physician to use TAMP and RenovoCath in that particular sarcoma patient?A: Sean Bhagat (CEO): This was a physician who became comfortable treating pancreatic cancer with the technology and saw a case with a difficult-to-treat sarcoma tumor. He believed RenovoCath would be a great opportunity to isolate flow and achieve good tumor penetration of the drug. Interventional radiologists are inventive and work across the entire body; as many doctors have told us, once they have the device in their hands, they see opportunities to use it with other tumors and patients. This is the beginning of adoption across a spectrum of areas. Q: How can learnings from activating the first set of commercial centers help facilitate the conversion of additional centers from your pipeline?A: Sean Bhagat (CEO): This is why we didn't hire a large sales force last yearto understand the sales cycle and process. We found there are many moving parts, including getting approvals to purchase the catheter and ensuring referring physicians know the technology is available. Key learnings to accelerate site activation include securing buy-in from multiple specialties, strong communication, and high-touch points. Having a small, dedicated field force showing up on-site is helping drive this, rather than pursuing a partnership at this early stage of market development. Q: With the recent industry attention on new pancreatic cancer therapies, how do you view these developments impacting RenovoRx's opportunity?A: Sean Bhagat (CEO): We see breakthroughs in pancreatic cancer therapy as complementary and a tailwind for our business. RenovoCath is a device to deliver treatments more optimally, and our TAMP technology is a localized drug delivery platform. We can deliver established drugs locally alongside novel therapies, and as new drugs come to market, many can be delivered directly via RenovoCath. In both cases, novel improved therapies make our targeted delivery platform even more valuable. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-12

RenovoRx Reports Record Second Quarter 2026 Results, Driven by Accelerating Commercial Adoption and 61% Sequential Quarterly Revenue Growth

GlobeNewswire
Increases 2026 Annual Revenue Guidance to a Range of $3.75M to $4.25M First Treatment Delivered with RenovoCath® in Patient with Sarcoma in Clinical Setting, Marking Expansion of Device to Other Solid Tumors Phase III TIGeR-PaC Trial Reaches Full Enrollment; Completion of Trial Expected in First Half 2027 with Topline Data Readout Expected in Second Half 2027 Management to Host Conference Call Today at 4:30 p.m. ET MOUNTAIN VIEW, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, FDA-cleared drug-delivery device, today announced its financial results for the second quarter ended June 30, 2026, and provided shareholders with a business update highlighting continued commercial momentum and clinical progress. “In the second quarter of 2026, we delivered record revenue and executed on all three of the milestones we set for the business: revenue growth with another record revenue quarter, commercial momentum evidenced by several cancer center activations, and expansion of the application of our technology beyond locally advanced pancreatic cancer (LAPC),” said Shaun Bagai, Chief Executive Officer of RenovoRx. “We generated quarterly revenue of $909,000, an increase of approximately 61% compared to the first quarter of 2026, and approximately 115% compared to the second quarter of 2025. Our strong first half performance gives us confidence that our second half revenue will exceed our original full year forecast. This outlook is driven by more active commercial cancer center customers, more patients treated via procedures with RenovoCath, and repeat ordering across our existing customer base.” Mr. Bagai continued, “We ended the second quarter with 21 active commercial cancer center customers, an increase of more than 30% from the 16 centers reported at the time of our first quarter earnings call, and expanded our total commercial pipeline to 63 centers, including 42 additional centers progressing through evaluation, approval, and activation. We continue to see meaningful repeat utilization across our existing customer base, and for the first time, a treating physician chose RenovoCath to deliver therapy to a patient with a solid tumor beyond pancreatic cancer, marking an important, physician-drive…Read full document

Increases 2026 Annual Revenue Guidance to a Range of $3.75M to $4.25M First Treatment Delivered with RenovoCath® in Patient with Sarcoma in Clinical Setting, Marking Expansion of Device to Other Solid Tumors Phase III TIGeR-PaC Trial Reaches Full Enrollment; Completion of Trial Expected in First Half 2027 with Topline Data Readout Expected in Second Half 2027 Management to Host Conference Call Today at 4:30 p.m. ET MOUNTAIN VIEW, Calif., Aug. 12, 2026 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, FDA-cleared drug-delivery device, today announced its financial results for the second quarter ended June 30, 2026, and provided shareholders with a business update highlighting continued commercial momentum and clinical progress. “In the second quarter of 2026, we delivered record revenue and executed on all three of the milestones we set for the business: revenue growth with another record revenue quarter, commercial momentum evidenced by several cancer center activations, and expansion of the application of our technology beyond locally advanced pancreatic cancer (LAPC),” said Shaun Bagai, Chief Executive Officer of RenovoRx. “We generated quarterly revenue of $909,000, an increase of approximately 61% compared to the first quarter of 2026, and approximately 115% compared to the second quarter of 2025. Our strong first half performance gives us confidence that our second half revenue will exceed our original full year forecast. This outlook is driven by more active commercial cancer center customers, more patients treated via procedures with RenovoCath, and repeat ordering across our existing customer base.” Mr. Bagai continued, “We ended the second quarter with 21 active commercial cancer center customers, an increase of more than 30% from the 16 centers reported at the time of our first quarter earnings call, and expanded our total commercial pipeline to 63 centers, including 42 additional centers progressing through evaluation, approval, and activation. We continue to see meaningful repeat utilization across our existing customer base, and for the first time, a treating physician chose RenovoCath to deliver therapy to a patient with a solid tumor beyond pancreatic cancer, marking an important, physician-driven expansion of the clinical application of our TAMP platform.” “Looking ahead, we remain focused on executing against both our near-term commercial priorities and our long-term clinical objectives,” added Mr. Bagai. “Based on current trends, we expect third quarter revenue to surpass second-quarter revenue and set another record. We remain on track to meet or exceed our target of 36 active commercial cancer center customers by year end 2026." "The recently announced enrollment completion of our Phase III TIGeR-PaC trial positions the majority of our trial sites to also transition to commercial use in the second half of the year. Reflecting our strong first half performance, we are raising and tightening the range for our full year revenue guidance. In short, we believe RenovoRx is building a durable, capital-efficient commercial business," said Mr. Bagai. "Management believe that reaching a quarterly revenue run-rate of approximately $5 million would position RenovoRx at cash-flow break-even, and based on our current trajectory, our internal plan anticipates achieving break-even operations in the fourth quarter of 2027." RenovoCath Commercialization UpdateRenovoRx delivered its strongest quarterly revenue performance to date. Revenue totaled $909,000 for the second quarter, an increase of approximately 61% compared to the first quarter of 2026 and approximately 115% compared to the second quarter of 2025. Second quarter revenue alone represented approximately 83% of the Company’s total revenue generated in all of 2025. For the six months ended June 30, 2026, revenue totaled approximately $1.5 million. This growth reflects continued expansion of active commercial cancer center customers and increasing procedural utilization of RenovoCath across the Company’s growing base of commercial sites. The Company’s commercial model is currently focused on activating new cancer center customers, which have been a source of recurring demand. RenovoRx ended the second quarter of 2026 with 21 active commercial cancer center customers, an increase of more than 30% from the 16 active customers reported at the time of the Company’s first quarter 2026 earnings call. RenovoRx is also advancing a customer pipeline of 42 additional centers in various stages of evaluation, approval, or activation. Combined with its 21 active customers, this represents a total of 63 centers in the Company’s commercial funnel, a 31% increase compared to the 48 total centers reported on its first quarter call. The Company remains on pace to meet or exceed its target of 36 active commercial cancer center customers by year end 2026. In addition, 15 Phase III TIGeR-PaC clinical trial sites are positioned to transition to commercial RenovoCath use, several of which have already begun doing so. These sites represent an anticipated and meaningful contributor to revenue in the second half of 2026. RenovoRx continues to observe strong repeat ordering from existing customers, which the Company views as one of the clearest indicators of physician satisfaction and clinical utility in interventional oncology. As physicians incorporate RenovoCath into routine clinical practice, repeat utilization is expected to drive sustained revenue growth. Based on its current customer pipeline and trends to date, the Company expects third quarter 2026 revenue to exceed second quarter revenue which would represent another consecutive record revenue quarter. Since receiving FDA 510(k) clearance, RenovoCath has been used in more than 900 successful procedures. RenovoRx continues to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device could translate into an approximately $400 million peak annual U.S. sales opportunity for RenovoRx. Over time, as the Company expands the platform into additional solid tumor indications, the Company believes it could unlock more than $1 billion in peak annual sales potential. Expansion of RenovoCath Beyond Locally Advanced Pancreatic CancerIn early August 2026, RenovoRx announced the first commercial clinical use of RenovoCath by an existing cancer center customer in the treatment of sarcoma, marking the expansion of its targeted drug-delivery device to solid tumors beyond pancreatic cancer. The case involved a physician who had previously treated LAPC patients using RenovoCath and returned to RenovoRx with a plan to use the catheter to treat sarcoma. The Company views this physician-driven adoption as a meaningful endorsement of RenovoCath’s potential as a standalone device across additional difficult-to-treat solid tumors within its FDA-cleared fields of use. Ongoing Phase III TIGeR-PaC Trial UpdateRecently, RenovoRx announced that it achieved full enrollment in its Phase III TIGeR-PaC trial evaluating intra-arterial delivery of intra-arterial gemcitabine (IAG) via the RenovoCath device for the treatment of LAPC. This significant milestone reflects successful patient recruitment, clinical execution, and collaboration among investigators and study teams evaluating IAG for LAPC, a difficult-to-treat cancer. The primary endpoint of the study is overall survival. TIGeR-PaC is designed to evaluate whether RenovoRx’s patented method of targeted delivery of the chemotherapy gemcitabine improves patient survival, safety, and tolerability compared to the standard of care (systemic (intravenous) chemotherapy gemcitabine + Abraxane). As of August 7, 2026, TIGeR-PaC trial investigators have been notified by RenovoRx that patient enrollment is closing. Completion of the trial is expected during the first half of 2027, after 86 events (i.e., patient deaths) have been observed. As of August 11, 2026, 78 events have occurred. Following completion of the trial, initial topline trial data is expected to be available during the second half of 2027. With enrollment complete, RenovoRx is now focused on advancing toward final data analysis. These efforts build on the successful completion of the second interim analysis in 2025, after which the independent Data Monitoring Committee recommended continuation of the trial without modification. To preserve trial integrity, the Company elected to defer publication of interim data until study completion. RenovoRx continues to view TIGeR-PaC as a critical long-term value driver, while emphasizing that its current commercial strategy is independent of the trial’s ultimate outcome and timeline. Second Quarter 2026 and Subsequent Key HighlightsRenovoRx continued to execute on its dual commercial and clinical strategy during the second quarter of 2026 and the subsequent period, building real-world evidence base for its TAMP platform. During the second quarter of 2026, several scientific data updates supported the use of intra-arterial gemcitabine delivery via TAMP in LAPC. A peer-reviewed case study by researchers at Moffitt Cancer Center, published in Radiology Case Reports, found that PET-CT imaging, rather than CT alone, showed a meaningful reduction in tumor metabolic activity after treatment. These findings suggest that PET imaging may help optimize monitoring of therapeutic response following TAMP-delivered treatment. In addition, the PK sub-study of the TIGeR-PaC trial has been accepted and will be published in the near future in the Journal of Cancer Chemotherapy and Pharmacology. The findings support TAMP as a targeted delivery method for gemcitabine, demonstrating its potential to increase local drug potency while reducing systemic exposure and common side effects. Finally, a peer-reviewed case series in Case Reports in Oncology from researchers at Hackensack Meridian Health’s Jersey Shore University’s Medical Center was accepted and will be published in the near future. The case series highlights their experience with the TAMP procedure in LAPC. The ramping up of publication of the TAMP procedure by physicians, the Company believes is another sign of adoption as TAMP traverses from an experimental procedure to becoming a potential standard of care. Cash Resources, History of Losses and Planned ActivitiesRenovoRx continued to build the evidence base for its TAMP platform through a multi-center post-marketing registry study generating real-world safety and efficacy data, as well as investigator-initiated trials (IITs) in borderline resectable and metastatic pancreatic cancer designed to achieve cost neutrality while broadening the platform’s evidence base. In the second quarter of 2026, the Company began supporting a new IIT in cholangiocarcinoma (bile duct cancer). RenovoRx received FDA Orphan Drug Designation for oxaliplatin in the treatment of pancreatic cancer in the second quarter of 2026, further expanding the potential applications of its targeted drug-delivery platform. Financial Highlights for the Second Quarter Ended June 30, 2026 Revenue for the three months ended June 30, 2026 was $909,000, compared to $422,000 for the three months ended June 30, 2025. The increase was driven by the continued commercialization of RenovoCath and expanding adoption across U.S. cancer centers. Gross profit for the three months ended June 30, 2026 was $766,000, representing a gross margin of approximately 84%, consistent with the approximately 85% gross margin in the first quarter of 2026 and reflecting the underlying economics of RenovoCath. Research and development expenses were approximately $1.2 million for the three months ended June 30, 2026, compared to approximately $1.4 million for the three months ended June 30, 2025. Selling, general, and administrative expenses were approximately $2.9 million for the three months ended June 30, 2026, compared to approximately $1.5 million for the three months ended June 30, 2025, a reflection of the Company’s continued execution on its commercial infrastructure strategy. Net loss for the three months ended June 30, 2026, was approximately $2.9 million, compared to approximately $2.9 million for the three months ended June 30, 2025. Net loss per share was $0.06 for the three months ended June 30, 2026, compared to a net loss of $0.08 for the three months ended June 30, 2025. Cash and cash equivalents were approximately $9.5 million as of June 30, 2026, compared to approximately $12.4 million as of March 31, 2026. This evidences the disciplined deployment of capital raised in the Company’s March 2026 private placement. The Company believes its current cash resources are sufficient to fund operations into the second half of 2027. Shares Outstanding: As of June 30, 2026, common shares outstanding totaled 45,121,982. Guidance: RenovoRx is raising and tightening the range of its full-year 2026 revenue guidance to a range of $3.75 million to $4.25 million, from its prior range of $3.0 million to $4.0 million. The updated guidance implies year-over-year revenue growth of approximately 241% to 286% compared to full-year 2025 revenue of $1.1 million. For interested individuals unable to join the conference call, a link to the recording will be available on RenovoRx’s Investor Relations website, and a dial-in replay will be available until August 26, 2026, and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number 13761368. 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 RenovoCathBased on its FDA clearance, RenovoCath® is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to select 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: https://renovorx.com/wp-content/uploads/2026/06/IFU-10004-Rev.-H-Universal-IFU.pdf. About RenovoRx, Inc.RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents. RenovoRx is actively commercializing its TAMP technology and FDA-cleared RenovoCath as a standalone device. For its first full year of commercial efforts in 2025, RenovoRx generated approximately $1.1 million in RenovoCath sales and a record $563,000 of sales in the first quarter of 2026. RenovoRx is actively working to expand the number of medical institutions initiating new RenovoCath orders, including esteemed, high-volume National Cancer Institute-designated centers. RenovoRx is also evaluating its novel drug-device combination oncology product candidate intra-arterial gemcitabine delivered via RenovoCath, (known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, which is FDA-cleared for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. RenovoRx achieved full enrollment in the TIGeR-PaC trial in August 2026, with completion of trial expected in first half 2027 and with topline data readout expected in second half 2027. The IAG combination product candidate, enabled by the RenovoCath device, 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 seven years of market exclusivity upon new drug application approval by the FDA. For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X. Non-GAAP Financial MeasuresIn addition to reporting financial results in accordance with U.S. generally accepted accounting principles (“GAAP”), the operating results presented in the accompanying tables include certain non-GAAP financial measures that exclude the non-cash expense associated with share-based compensation. We are providing such non-GAAP financial information in this press release, including non-GAAP operating expenses, net income (loss), and earnings (loss) per share, as a supplement to our consolidated financial statements prepared in accordance with GAAP which appear in this press release and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 as filed with the U.S. Securities and Exchange Commission. Our management uses these non-GAAP measures internally to analyze financial results, evaluate operational performance, and assess liquidity. We believe that both management and investors benefit from referring to these non-GAAP measures when assessing performance and when planning, forecasting, and analyzing future periods. We believe these non-GAAP measures also enhance investors’ understanding of key financial metrics used in operational decision-making and are useful for comparing our performance to that of other companies. However, readers are cautioned that non-GAAP results are presented for supplemental information purposes only and should not be considered a substitute for GAAP financial information. These measures may differ from similarly titled non-GAAP measures presented by other companies. Moreover, non-GAAP financial measures are not required to be uniformly applied and are not audited. Cautionary Note Regarding Forward-Looking StatementsThis press release and statements of the Company’s management and third parties 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 clinical trials and studies (including expectations for full enrollment and data read out), (ii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and (iii) our efforts to commercialize our RenovoCath and TAMP technology for use in treating pancreatic and other solid tumor cancers, and our expected financial results from such efforts, including our estimates for 2026 annual revenue. 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 and other business plans, intellectual property development, clinical trials, our therapy platform, financing plans, objectives, and expected operating results, all of 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,” “aim,” “goal,” “estimates,” “intends,” and “potential,” or derivatives of these terms or other comparable terminology regarding RenovoRx’s statements about the future, 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 commercial efforts our TAMP technology (enabled by RenovoCath) may not lead to the achievement of our revenue forecasts or to viable, revenue generating operations in general; (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, completion and potential results (including the results of interim analyses) of our preclinical studies, clinical trials, and our research programs (notably with respect to our TIGeR-PaC trial); (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 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, needs for additional financing, our ability to obtain additional capital and our ability to maintain the listing of our common stock on Nasdaq; (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 scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates, and research programs; (xviii) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xix) the pricing, coverage, and reimbursement of our product candidates, if approved; and (xx) 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, which can be accessed at https://ir.renovorx.com/sec-filings. 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. Investor Contact:KCSA Strategic CommunicationsValter Pinto or Jack PerkinsT: [email protected] Media Contact:STiR CommunicationsHannah WilliamsT: [email protected]

TranscriptFY2026 Q22026-08-12

FY2026 Q2 earnings call transcript

Earnings source - 52 paragraphs
Operator

Good afternoon. I will be your conference call operator today. Please note that today's call is being recorded, and all participants, other than management, are in listen-only mode. There will be a Q&A session following management's presentation. I will now turn the call over to Valter Pinto, Managing Director of KCSA Strategic Communications. Please go ahead.

Valter Pinto

Thank you, operator. Good afternoon, and welcome everyone to the RenovoRx second quarter 2026 financial results conference call. I am joined today by members of our leadership team, including Shaun Bagai, Chief Executive Officer, Dr. Ramtin Agah, Chief Medical Officer, Executive Chair, and Founder, and Mark Voll, Chief Financial Officer. Before we begin, I would like to remind everyone that statements made during today's call contain or may contain forward-looking statements covered by the safe harbor provisions that are part of the Private Securities Litigation Reform Act of 1995 and applicable federal securities laws. These statements, including statements regarding RenovoRx's clinical and commercial plans, strategies, and estimates or expectations of financial or operational performance, including revenue, are based on management's current plans and assumptions, and actual results may differ materially.

Valter Pinto

Please refer to our filings with the SEC, including our Form 10-Q for the quarter ended June 30th, 2026, for a detailed discussion of the risks and uncertainties facing RenovoRx. With that, I would now like to turn the call over to our Chief Executive Officer, Shaun Bagai.

Shaun Bagai

Thank you, Valter, and good afternoon, everyone. Over the past several quarters, we set out three milestones for RenovoRx. In this quarter, we delivered on all three. First, revenue growth. The second quarter was a record revenue quarter, our strongest to date. Second, commercial momentum. We activated new commercial cancer centers at a pace ahead of our internal targets. Third, expansion beyond locally advanced pancreatic cancer. For the first time, a treating physician chose RenovoCath to deliver therapy to a patient with a different solid tumor. We told our investors we were going to achieve these goals, and we delivered. Last quarter, we spoke openly about the meaningful progress we have made on the commercialization of RenovoCath, shifting our narrative from concept to execution and growth. This quarter shows our commercial execution in action with our highest quarterly revenue, and we could not be more excited about our future.

Shaun Bagai

Our job now is to keep delivering quarter after quarter. For the second quarter ended June 30, 2026, RenovoRx generated record revenue of $909,000, our strongest quarterly performance to date, increasing approximately 61% sequentially and approximately 115% year-over-year. To put this performance in perspective, our second quarter revenue alone represented approximately 83% of our entire full year 2025 revenue of $1.1 million. This is the direct, measurable result of the commercial model we have described. More active commercial cancer center customers, more procedures, and more revenue. With each new center we activate adding to our growth and creating a compounding effect. Let's walk through our predictors of our future revenue. Revenue growth is the outcome, but the leading indicator of continued revenue growth in the coming quarters and the metric I would encourage investors to continue to watch most closely is new account activations.

Shaun Bagai

Our activated commercial cancer centers to date have been a source of recurring repeat demand, so the pace at which we activate accounts is what gives us confidence in future revenue growth. On that measure, our progress is clear. At the time of our May 14th earnings call, we had 16 active commercial cancer centers. We ended the second quarter with 21 active commercial cancer centers, an increase of more than 30% in just one quarter. We remain on pace to meet or exceed our target of 36 active commercial cancer centers by year-end 2026. The majority of these paying customers are cancer centers that purchase RenovoCath are distinct from the clinical trial research sites participating in our phase III TIGeR-PaC study. Our customer pipeline beyond those active centers is robust.

Shaun Bagai

In addition to our 21 active customers, we have 42 additional centers in various stages of evaluation, approval, and activation, representing a total of 63 centers in our commercial funnel. The growth of our total customer funnel is a 31% increase over the 48 centers we reported on our first quarter call. In addition, 15 of our TIGeR-PaC trial sites are positioned to move to commercial RenovoCath use, and several have already begun doing so. As these sites transition, we expect them to be a meaningful contributor to our revenue in the second half of 2026. Another key metric of commercial success is repeat orders. We continue to see strong repeat ordering from our existing customers, which is one of the clearest indicators of physician satisfaction and product utility in interventional oncology.

Shaun Bagai

When a physician places a second, third, and fourth order for RenovoCath, it confirms the product is delivering an important treatment option and clinical utility for their patients. Given our customer pipeline and based on what we're seeing so far in terms of repeat orders, our third-quarter revenue is tracking to exceed the second quarter and become yet another record revenue quarter. This commercial growth and strong customer pipeline are driven by a lean commercial team that is in place and executing. The results certainly speak for themselves. Going forward, we may incrementally add to our sales team where a specific market opportunity warrants it, but our growth model remains focused on efficient capital allocation and investing into our growth as needed. We are deploying the capital from our March capital raise prudently and effectively, and we are generating a strong return on that investment.

Shaun Bagai

We reduced our operating loss for the quarter, and as our revenue scales, we expect our operating loss will continue to decline. Physician-to-physician advocacy continues to grow, which is historically the most powerful driver of adoption in interventional oncology. Since receiving FDA 510(k) clearance, RenovoCath has been used in more than 900 successful procedures. Before I turn the call over to Ramtin, I want to take a moment to touch on the current overall pancreatic cancer market and how we believe this benefits us. There has been significant industry attention recently on new therapies for pancreatic cancer, and we believe those developments represent a meaningful opportunity for RenovoRx. Because RenovoCath is a device to deliver treatments more optimally, we see breakthroughs in pancreatic cancer therapy as complementary and as an important tailwind for our business.

Shaun Bagai

Beyond always putting the patient first for this deadly disease, I want to remind everyone that our TAMP technology, enabled by RenovoCath, is a collaborative, localized drug delivery platform with two ways emerging therapies can strengthen our opportunity. First, we can deliver established drugs locally, sequentially, or concurrently with novel therapies, creating the potential for improved patient outcomes, concentrating therapy where it is needed. Second, as new drugs come to market, we believe many of them can be delivered directly by our RenovoCath device. In both cases, our view is that novel improved therapies make our targeted delivery platform even more valuable. We recently announced the first commercial clinical use of RenovoCath in sarcoma treatment, marking the expansion of our targeted drug delivery device to other solid tumors and showing real-world potential for expansion of localized delivery of chemotherapy.

Shaun Bagai

Ramtin will go into more detail about this milestone, but it is important to note that this expansion is physician-driven, an important and encouraging element as we look towards the potential for broader adoption of RenovoCath. In closing, I could not be more proud of our team for their execution and hard work. The second quarter was a record quarter for us, not only from a revenue perspective, but also across all our key metrics, including growing customer pipeline, high retention rate, and repeat orders. With that, I'll turn the call over to our Chief Medical Officer, Executive Chair, and Founder, Dr. Ramtin Agah.

Ramtin Agah

Thank you, Shaun, and good afternoon, everyone. Before discussing the broader opportunity, let me briefly remind everyone of the science at the core of what we're building. Our patented Trans-Arterial Micro-Perfusion, or TAMP technology, enables targeted therapeutic delivery across the arterial wall near the tumor site, designed to bathe the target tumor while potentially minimizing a therapy's toxicity versus systemic intravenous therapy. For patients fighting solid tumor cancers while also managing the debilitating side effects of treatment, that difference matters. For decades, cancer care has rested on three pillars, surgery, radiation, systemic chemotherapy. We believe TAMP, enabled by RenovoCath, represents a fourth option, one that is targeted, tolerable, and increasingly supported by growing body of real-world clinical evidence. As Shaun mentioned, earlier this month, we announced the first commercial clinical use of RenovoCath in sarcoma treatment, showing the real-world potential beyond LAPC for expansion of localized delivery of chemotherapy.

Ramtin Agah

This first commercial sarcoma case marks an important milestone for RenovoRx, demonstrating RenovoCath's potential as a standalone device for treatment of other solid tumors beyond our core focus on locally advanced adenocarcinoma of the pancreas. This was a case where a physician who has treated LAPC using RenovoCath came back to RenovoRx with a plan to use our catheter to treat sarcoma, and we believe that this is a powerful endorsement of RenovoCath's potential. We believe targeted localized delivery may offer advantages over systemic treatment for many other difficult-to-treat solid tumors, and we look forward to working with our cancer center customers to find new and broadening use of RenovoCath within its FDA cleared fields of use. In the second quarter of 2026, several scientific data updates supported the use of intra-arterial gemcitabine delivery via TAMP in LAPC.

Ramtin Agah

A peer-reviewed case study by researchers at Moffitt Cancer Center, published in Radiology Case Reports, found that PET-CT imaging, rather than CT alone, showed a meaningful reduction in tumor metabolic activity after treatment. These findings suggest that PET imaging may help optimize monitoring of therapeutic response following TAMP-delivered treatment. In addition, the PK sub-study of the TIGeR-PaC trial has been accepted and soon to be published in the Journal of Cancer Chemotherapy and Pharmacology. The findings support TAMP as a targeted delivery method for gemcitabine, demonstrating its potential to increase local drug potency while reducing systemic exposure and common side effects. Finally, a peer-reviewed case series case reports in oncology from researchers at Hackensack Meridian Health Jersey Shore University Medical Center was accepted and will be published in the near future. The case series highlights their experience with TAMP procedure in LAPC.

Ramtin Agah

The ramping up of publications of TAMP procedure by physicians, I believe, is another sign of adoption as TAMP traverses from an experimental procedure to becoming standard of care. Earlier this week, we were pleased to announce that RenovoRx has achieved full enrollment in our phase III TIGeR-PaC trial for locally advanced pancreatic cancer. This significant milestone reflects years of patient recruitment, clinical execution, and collaboration among investigators and study team evaluating intra-arterial gemcitabine delivered through RenovoRx's Trans-Arterial Micro-Perfusion, or TAMP platform, a RenovoCath device as a novel drug device product candidate for difficult-to-treat LAPC. The primary endpoint of the study is overall survival. TIGeR-PaC is designed to evaluate whether RenovoRx's patented method of targeted delivery of the chemotherapy gemcitabine improves patient survival, safety, and tolerability compared to standard of care. Systemic intravenous chemotherapy, gemcitabine plus ABRAXANE.

Ramtin Agah

On August 7th, TIGeR-PaC trial investigators were notified that patient enrollment is closing. Completion of the trial is expected during the first half of 2027, after 86 events have been observed. As of August 11th, 2026, 78 events have occurred. Following the completion of the trial, initial top-line data is expected to be available during the back half of 2027. TIGeR-PaC is the cornerstone of our clinical development program, bringing us closer than ever in our effort to validate IAG and its efficacy through rigorous long-term evaluation. Completing enrollment in the phase III TIGeR-PaC trial marks a major milestone for RenovoRx and our clinical program. With enrollment complete, we are now focused on advancing towards final data analysis. We believe TIGeR-PaC will provide meaningful additional validation of our TAMP therapy platform in an area with significant unmet need and limited therapeutic progress.

Ramtin Agah

The trial is designed to demonstrate the potential safety and superiority of intra-arterial gemcitabine delivered via RenovoCath for locally advanced pancreatic cancer versus systemic IV chemotherapy, the current standard of care. I want to underscore a very important point. The transition of TIGeR-PaC sites is additive to our commercial expansion story, not separate from it. As Shaun noted, several of these sites have already begun moving to commercial RenovoCath use. As more do, they join our growing network of active commercial cancer centers. This is an anticipated and meaningful contributor to our second half 2026 revenue. In parallel with TIGeR-PaC, we continue to build the evidence base for TAMP platform. Our post-marketing registry study is a multi-center study generating real-world safety and efficacy data in patients with solid tumors.

Ramtin Agah

We also continue to support Investigator-Initiated Trials, or IITs, in borderline resectable and metastatic pancreatic cancer, which are designed to achieve cost neutrality while broadening the platform's evidence base. In the second quarter of 2026, we began supporting a new IIT study for cholangiocarcinoma, or bile duct cancer, which is in process to begin soon. Clinical data builds physician confidence. Physician confidence drives adoption, and adoption drives revenue. Commercial traction is now the foreground of the RenovoRx story, and our TIGeR-PaC clinical trial is important background. We are a scaling commercial business today, not a binary event bet. At the same time, the trial remains a significant long-term value driver, and a positive phase III readout would have meaningful positive implications for physician adoption and reimbursement. Once we reach break-even, we believe RenovoRx can be a profitable, high-margin, low-overhead, cash-generating business, a rare profile in our space.

Ramtin Agah

Thank you for your interest in RenovoRx. I will turn the call over to our Chief Financial Officer, Mark Voll.

Mark Voll

Thank you, Ramtin, and good afternoon, everyone. The second quarter was a strong quarter for RenovoRx, and the financial results reflect meaningful progress on our commercial plan. Let me walk you through the numbers. For the second quarter ending June 30, 2026, RenovoRx reported record revenue of $909,000, our strongest quarter to date. That is approximately 61% growth versus first quarter revenue of $563,000, and approximately 115% growth versus $422,000 in the second quarter of 2025. This growth was driven by continued active commercial center expansion and repeat ordering from our existing customer base. Gross profit for the second quarter was $766,000, representing a gross margin of approximately 84%, consistent with our roughly 85% gross margin we reported in the first quarter and reflecting the strong underlying economics of RenovoCath.

Mark Voll

Research and development expenses for the second quarter were approximately $1.2 million, reflecting our continued investment in the phase III TIGeR-PaC trial, our post-marketing registry study, and our investigator-initiated trial programs. Selling, general, and administrative expenses were approximately $2.9 million, reflecting the disciplined investment we have made to build and support our commercial infrastructure. Loss from operations for the quarter was approximately $3.4 million, an improvement from the $3.5 million operating loss in the prior quarter. However, adjusting both periods to exclude the non-cash expense for stock-based compensation, our second quarter operating loss was approximately $370,000 less than our first quarter operating loss. As our revenue scales, we expect our operating loss will continue to decline. Net loss per share improved to $0.06 compared to a loss of $0.08 in the second quarter of 2025 and a loss of $0.09 in the prior quarter.

Mark Voll

As of June 30th, 2026, RenovoRx had approximately $9.5 million in cash and cash equivalents, compared with approximately $12.4 million at March 31st, 2026. This change aligns with our internal forecast and reflects the disciplined deployment of capital we raised in March. Importantly, assuming our revenue scales as we anticipate, our active site count grows, our cash burn will continue to decline. We believe our cash position provides sufficient runway to fund operations into the second half of 2027 as we continue to work towards our goal of cash flow positive operations. We will be opportunistic if capital market conditions are favorable, but raising capital is not our focus today. Our priority is revenue generation and execution. Management believes that reaching a quarterly revenue run rate of approximately $5 million would position RenovoRx at cash flow break even.

Mark Voll

Based on our current trajectory, our internal plan anticipates achieving break-even operations in the fourth quarter of 2027, and we expect to make steady progress towards that run rate as our active site count scales towards and beyond our year-end target of 36 centers. Reflecting on our strong first half performance, we are raising and tightening the range of our full year 2026 revenue guidance to a range of $3.75 million-$4.25 million from our prior range of $3 million-$4 million. This increase reflects our confidence in continued revenue scaling in the second half of this year. This new guidance implies year-over-year growth of 241%-286% in 2026, compared to revenue of $1.1 million in 2025. Beyond revenue, our primary commercial KPI remains active commercial center count.

Mark Voll

We are at 21 active commercial centers at quarter end, and are targeting 36 or more by year end. As TIGeR-PaC sites continue their transition to commercial use in the second half of this year, we expect that activity contribute meaningful to revenue. Executing within our guidance range keeps us on the path we have laid out towards cash flow positive operations. Thank you. I'll turn the call back to the operator for Q&A.

Operator

Thank you. We will now begin the question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Our first question is from Justin Walsh with JonesTrading. Please proceed with your question.

Justin Walsh

Hi. Thanks for taking the questions. I was wondering if you could provide additional color on what prompted the physician to use TAMP and RenovoCath in that particular sarcoma patient.

Ramtin Agah

Justin, thanks for the question. As we've been talking about the utility of this technology to reach more tumors is out there. This is a physician who's gotten comfortable with treating pancreatic cancers specifically, and based on that, he saw a case where there's a difficult to reach sarcoma tumor. These are challenging cases in general. With that, he thought this would be a great opportunity to be able to utilize RenovoCath to isolate flow and really get good tumor penetration of the drug. It's what we expect. Radiologists are quite inventive in terms of physicians, given that they work across the entire body. As we've been told by many doctors, is once we get this in their hands, they will see themselves getting in positions where they could utilize this with other tumors and other patients.

Ramtin Agah

It's, I believe, the beginning of adoption across the spectrum in several areas, and it's great to see that he took the opportunity here to help one of his patients with our technology.

Justin Walsh

Great. Thanks. One more question from me. I am wondering if you can expand on how learnings from activating the first set of commercial centers can help facilitate your efforts to convert the additional centers from your pipeline.

Mark Voll

That's a great question, Justin. That's one of the reasons we didn't hire a big sales force last year, is to really understand what the sales cycle and sales process is. We found that there are a lot of moving parts in terms of getting VAC approvals to be able to purchase the catheter. Also, in terms of referring patients and making sure that referring patients know that the technology is now available when it becomes available, and the radiologists are connected with those physicians as well. I think a lot of the learnings to accelerate that site activation, and we've seen this, is to ensure that we've got buy-in from multiple specialties, strong communication, and a lot of touch points. Now having a field force in the field and constant communication and showing up on site is really helping drive that.

Mark Voll

That was important to have that focus with a small, dedicated sales force.

Shaun Bagai

Versus going out to look at a partnership this early stage in market development to ensure that we actually get products on the shelves and then get referring physicians in with high touch points from our local reps.

Operator

Our next question is from [Charles Wallace] with H.C. Wainwright. Please proceed with your question.

Speaker 6

Hi. Thanks for taking my questions. First one from me. Congrats on finishing enrollment for the TIGeR-PaC study. I was wondering, now that enrollment's closed, how many of the patients actually ended up randomized? I guess I'm asking if the full 114 patients were randomized at this point, or if the number actually fell above or below that.

Shaun Bagai

We haven't yet completed randomization. That's still in process. We didn't report publicly the exact number, but we're very close in terms of completing randomization with a handful of patients left. Part of allowing the study to be open a little bit longer than June, like we anticipated, was to be able to have physicians enroll patients, have them in the induction phase, so if there are dropouts, we'd be able to randomize the 114th patient without issue. We do have that buffer now. So we'll be pretty close to randomization completion here.

Speaker 6

Okay. That's very helpful. Then I guess on the site activation, now that you're at 21 active sites, it's, I think, a five gain from the first quarter. What gives you confidence that you can reach the 36 centers by the end of the year? How many of these are from the clinical trial conversion?

Shaun Bagai

It is interesting.

Speaker 6

Thank you.

Shaun Bagai

The 21 is as of the end of the quarter, so we have activated more since then, which we will report out in the not too distant future. What gives us confidence is that we have 42 additional centers that are in the process. Well over 36 total, with the bulk of the 15 TIGeR-PaC sites not yet treating commercially. A handful of those wanted to wait till enrollment is complete, so they would not have a competing interest from the physicians. We anticipate starting to activate those over the next quarter or two. Those should contribute meaningfully to the revenue, but the other 40 or so plus in the customer pipeline will also allow us to overachieve that 36 target by the end of the year.

Speaker 6

That is helpful. I guess on this, another follow-up on that. On the clinical trial sites that become active commercial sites, what is your anticipation of the timeline from when they are activated to when they order?

Shaun Bagai

Actually, that's a great point, Charles, and good clarification. So when we say active, these are actually They've already purchased a catheter and treated a patient. What we didn't want to do is start looking at sites that either are ready to go or have not purchased a device yet. So when we say active, these are actually purchasing, using customers. And the other 42 in the pipeline could be somewhere along the process, including being green-lit to order, may have ordered already, but haven't treated their first patient. So they're real active commercial sites.

Speaker 6

Great. Thanks, Shaun, for answering all my questions.

Shaun Bagai

Good question. Thanks, Charles.

Operator

Our next question is from [Ed Wu] from Ascendiant Capital Markets. Please proceed with your question.

Speaker 7

Sure. That is close enough. I want to congratulate you guys on all the progress on both fronts. My question is, as you guys scale up the volume for the RenovoCath, do you think your margins can go higher, gross margin, operating margin, as you guys scale up in volume?

Shaun Bagai

Yeah. Good question, Ed. I think that we have the opportunity to do that when we get to our next generation product, which we will introduce sometime next year. I think that will allow us to increase the gross margins from our current level.

Speaker 7

Great. That sounds good. My second question is on these additional centers that you guys have in process, is there any difference in terms of the volume or business potentials with the first 21 that you have already activated? Are they much smaller? Are they the same size, revenue potential for these additional centers beyond that you already have?

Shaun Bagai

Yeah, great question, Ed. What is great to see is that the 21 is a good representation of this full spectrum. So within those active centers, we have a couple of the high volume centers, and we have some of the smaller community-based hospitals. If you look at the heat map of about 200 target centers, with the bulk of them being treated at a small number of centers, we have not hit all the high volume places yet. So there is a lot of opportunity here for revenue growth. Mark, I am not sure if you want to maybe touch on the 200 a little bit more in detail.

Mark Voll

Right. When we look at the market, it's pretty concentrated. The top 10 advanced cancer centers represent about 25% of the market. While we're really targeting the larger ones, we're still looking at a broad range of active cancer centers to bring online. But again, getting the larger centers will give us the largest amount of revenue opportunity in those centers.

Speaker 7

Great. Well, it's glad that you guys have very good representative samples in your 21 centers so far. I really appreciate you guys answering my questions, and I wish you guys good luck. Thank you.

Shaun Bagai

Thank you, Ed. I believe that concludes the questions remaining. I want to thank everyone for joining, and excited to have you along this journey as we really demonstrate progress and really, again, capitalizing on our three major missions that took place this last quarter in driving revenue, increasing our commercial centers, and now expanding the technology beyond pancreatic cancer. Looking forward to many great quarters ahead, and if you have questions, please do follow up.

Operator

This concludes today's conference call. Thank you for your participation. You may now disconnect.

Investor releaseQuarter not tagged2026-08-11

RenovoRx Inc (RNXT) Q2 2026: Everything You Need To Know Ahead Of Earnings

GuruFocus.com

This article first appeared on GuruFocus. RenovoRx Inc (NASDAQ:RNXT) is set to release its Q2 2026 earnings on Aug 12, 2026. The consensus estimate for Q2 2026 revenue is 0.72 million, and the earnings are expected to come in at -0.07 per share. The full year 2026's revenue is expected to be $3.2 million and the earnings are expected to be $-0.3 per share. More detailed estimate data can be found on the Forecast page Warning! GuruFocus has detected 1 Warning Sign with RNXT. Is RNXT fairly valued? Test your thesis with our free DCF calculator. Revenue estimates for RenovoRx Inc (NASDAQ:RNXT) have declined from $3.24 million to $3.2 million for the full year 2026 and declined from $12.32 million to $12.29 million for 2027 over the past 90 days. Earnings estimates for RenovoRx Inc (NASDAQ:RNXT) have declined from $-0.29 per share to $-0.3 per share for the full year 2026 and flattened at $-0.15 per share for 2027 over the past 90 days. In the previous quarter of 2026-03-31, RenovoRx Inc's (NASDAQ:RNXT) actual revenue was $0.56 million, which beat analysts' revenue expectations of $0.463 million by 21.6%. RenovoRx Inc's (NASDAQ:RNXT) actual earnings were $-0.09 per share, which missed analysts' earnings expectations of $-0.083 per share by -8.43%. After releasing the results, RenovoRx Inc (NASDAQ:RNXT) was down by -4.09% in one day. Based on the one-year price targets offered by 4 analysts, the average target price for RenovoRx Inc (NASDAQ:RNXT) is $7 with a high estimate of $14 and a low estimate of $3. The average target implies an upside of 503.45% from the current price of $1.16. Based on the consensus recommendation from 4 brokerage firms, RenovoRx Inc's (NASDAQ:RNXT) average brokerage recommendation is currently 2.0, indicating an "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.

Investor releaseQuarter not tagged2026-08-06

Regenxbio (RGNX) Beats Q2 Earnings and Revenue Estimates

Zacks
Regenxbio (RGNX) came out with quarterly earnings of $0.43 per share, beating the Zacks Consensus Estimate of $0.12 per share. This compares to a loss of $1.38 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +258.33%. A quarter ago, it was expected that this biotechnology company would post a loss of $1.36 per share when it actually produced a loss of $1.72, delivering a surprise of -26.47%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Regenxbio, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $108.02 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 16.31%. This compares to year-ago revenues of $21.36 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Regenxbio shares have lost about 27.1% since the beginning of the year versus the S&P 500's gain of 12.8%. While Regenxbio has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Regenxbio was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (…Read full document

Regenxbio (RGNX) came out with quarterly earnings of $0.43 per share, beating the Zacks Consensus Estimate of $0.12 per share. This compares to a loss of $1.38 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +258.33%. A quarter ago, it was expected that this biotechnology company would post a loss of $1.36 per share when it actually produced a loss of $1.72, delivering a surprise of -26.47%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Regenxbio, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $108.02 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 16.31%. This compares to year-ago revenues of $21.36 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Regenxbio shares have lost about 27.1% since the beginning of the year versus the S&P 500's gain of 12.8%. While Regenxbio has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Regenxbio was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.93 on $37.5 million in revenues for the coming quarter and -$3.69 on $180.65 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. RenovoRx, Inc. (RNXT), another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 12. This company is expected to post quarterly loss of $0.08 per share in its upcoming report, which represents no change from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. RenovoRx, Inc.'s revenues are expected to be $0.73 million, up 72.6% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report REGENXBIO Inc. (RGNX) : Free Stock Analysis Report RenovoRx, Inc. (RNXT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-08-03

Krystal Biotech, Inc. (KRYS) Q2 Earnings and Revenues Beat Estimates

Zacks
Krystal Biotech, Inc. (KRYS) came out with quarterly earnings of $1.79 per share, beating the Zacks Consensus Estimate of $1.7 per share. This compares to earnings of $1.29 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +5.29%. A quarter ago, it was expected that this company would post earnings of $1.45 per share when it actually produced earnings of $1.83, delivering a surprise of +26.21%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Krystal Biotech, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $119.22 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 0.14%. This compares to year-ago revenues of $96.04 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Krystal Biotech shares have added about 38.4% since the beginning of the year versus the S&P 500's gain of 9.4%. While Krystal Biotech has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Krystal Biotech was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of…Read full document

Krystal Biotech, Inc. (KRYS) came out with quarterly earnings of $1.79 per share, beating the Zacks Consensus Estimate of $1.7 per share. This compares to earnings of $1.29 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +5.29%. A quarter ago, it was expected that this company would post earnings of $1.45 per share when it actually produced earnings of $1.83, delivering a surprise of +26.21%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Krystal Biotech, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $119.22 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 0.14%. This compares to year-ago revenues of $96.04 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Krystal Biotech shares have added about 38.4% since the beginning of the year versus the S&P 500's gain of 9.4%. While Krystal Biotech has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Krystal Biotech was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $1.89 on $126.5 million in revenues for the coming quarter and $7.31 on $500.9 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. RenovoRx, Inc. (RNXT), another stock in the same industry, has yet to report results for the quarter ended June 2026. The results are expected to be released on August 12. This company is expected to post quarterly loss of $0.08 per share in its upcoming report, which represents no change from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. RenovoRx, Inc.'s revenues are expected to be $0.73 million, up 72.6% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report RenovoRx, Inc. (RNXT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-07-29

RenovoRx to Host Second Quarter 2026 Financial Results and Business Highlights Conference Call on August 12th at 4:30 p.m. ET

GlobeNewswire
MOUNTAIN VIEW, Calif., July 29, 2026 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or “the Company”) (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, FDA-cleared drug-delivery device, today announced that it will host its second quarter 2026 financial results and business highlights conference call on August 12, 2026, at 4:30 p.m. ET. During the call, RenovoRx management will discuss the Company’s growing revenues from commercial sales of RenovoCath as a standalone drug-delivery device, as well as increased RenovoCath adoption at high-volume U.S. cancer centers and a broader base of repeat orders from existing customers. Management will also provide an update on the Phase III TIGeR-PaC clinical trial evaluating intra-arterial gemcitabine delivered via RenovoCath in locally advanced pancreatic cancer, with full enrollment in the trial expected in the very near future and final data anticipated in mid-to-late 2027. RenovoRx continues to strengthen its oncology pipeline and broaden the clinical utility of its proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform which is enabled by RenovoCath. Recent progress includes FDA Orphan Drug Designation for oxaliplatin in pancreatic cancer, along with continued support for investigator-initiated trials (IITs) in borderline resectable and metastatic pancreatic cancer, and exploration of additional indications, and an ongoing post-marketing registry study. Together, these efforts are expected to generate meaningful clinical evidence to support broader adoption of TAMP across multiple oncology indications. Conference Call Details: For interested individuals unable to join the conference call, a link to the recording will be available on RenovoRx’s Investor Relations website, and a dial-in replay will be available until August 26, 2026, and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number 13761368. About RenovoRx, Inc.RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platfor…Read full document

MOUNTAIN VIEW, Calif., July 29, 2026 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or “the Company”) (Nasdaq: RNXT), a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, FDA-cleared drug-delivery device, today announced that it will host its second quarter 2026 financial results and business highlights conference call on August 12, 2026, at 4:30 p.m. ET. During the call, RenovoRx management will discuss the Company’s growing revenues from commercial sales of RenovoCath as a standalone drug-delivery device, as well as increased RenovoCath adoption at high-volume U.S. cancer centers and a broader base of repeat orders from existing customers. Management will also provide an update on the Phase III TIGeR-PaC clinical trial evaluating intra-arterial gemcitabine delivered via RenovoCath in locally advanced pancreatic cancer, with full enrollment in the trial expected in the very near future and final data anticipated in mid-to-late 2027. RenovoRx continues to strengthen its oncology pipeline and broaden the clinical utility of its proprietary TAMP™ (Trans-Arterial Micro-Perfusion) therapy platform which is enabled by RenovoCath. Recent progress includes FDA Orphan Drug Designation for oxaliplatin in pancreatic cancer, along with continued support for investigator-initiated trials (IITs) in borderline resectable and metastatic pancreatic cancer, and exploration of additional indications, and an ongoing post-marketing registry study. Together, these efforts are expected to generate meaningful clinical evidence to support broader adoption of TAMP across multiple oncology indications. Conference Call Details: For interested individuals unable to join the conference call, a link to the recording will be available on RenovoRx’s Investor Relations website, and a dial-in replay will be available until August 26, 2026, and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number 13761368. About RenovoRx, Inc.RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents. RenovoRx is actively commercializing its TAMP technology and FDA-cleared RenovoCath as a standalone device. For its first full year of commercial efforts in 2025, RenovoRx generated approximately $1.1 million in RenovoCath sales and a record $563,000 of sales in the first quarter of 2026. RenovoRx is actively working to expand the number of medical institutions initiating new RenovoCath orders, including esteemed, high-volume National Cancer Institute-designated centers. RenovoRx is also evaluating its novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, which is FDA-cleared for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. RenovoRx anticipates full enrollment in the TIGeR-PaC trial in the very near term and final data readout in mid-to-late 2027. The IAG combination product candidate, enabled by the RenovoCath device, 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 seven years of market exclusivity upon new drug application approval by the FDA. For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X. Cautionary Note Regarding Forward-Looking StatementsThis press release, the conference call described herein, and statements of the Company’s management and third parties 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 clinical trials and studies, (ii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and (iii) our efforts to commercialize our RenovoCath and TAMP technology. Statements that are not purely historical are forward-looking statements. These and other 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, intellectual property development, clinical trials, our therapy platform, commercial and other business plans, financing plans, objectives, and expected operating results, which are based on such 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,” “aim,” “goal,” “estimates,” “intends,” and “potential,” or derivatives of these terms or other comparable terminology regarding RenovoRx’s statements about the future, although not all forward-looking statements contain these words. Risks, uncertainties and assumptions that could cause actual events to differ materially from those projected or indicated by forward-looking statements, include, without limitation: (i) the risk that our commercial efforts with our TAMP technology may not lead to viable, 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 of our 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 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, needs for additional financing, our ability to obtain additional capital and our ability to maintain the listing of our common stock on Nasdaq; (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 scope of protection we are able to establish and maintain for intellectual property rights, including our therapy platform, product candidates, and research programs; (xviii) our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately; (xix) the pricing, coverage, and reimbursement of our product candidates, if approved; and (xx) 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, which can be accessed at https://ir.renovorx.com/sec-filings. 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. Investor Relations Contact:KCSA Strategic CommunicationsValter Pinto or Jack PerkinsT: [email protected] Media Contact:STiR CommunicationsHannah WilliamsT: [email protected]

Investor releaseQuarter not tagged2026-05-19

RenovoRx (RNXT) Q1 2026 Earnings Transcript

Motley Fool
Image source: The Motley Fool. Thursday, May 14, 2026, at 4:30 p.m. ET Chief Executive Officer — Shaun R. Bagai Chief Medical Officer and Executive Chair — Ramtin Agah, M.D. Chief Financial Officer — Mark Voll Valter Pinto: Thank you, Operator. Good afternoon, everyone, and welcome to the RenovoRx first quarter 2026 earnings conference call. I'm joined today by members of our leadership team, including Dr. Ramtin Agah, Chief Medical Officer and Executive Chair, Shaun Bagai, Chief Executive Officer, and Mark Ball, Chief Financial Officer. Before we begin, I'd like to remind everyone that statements made during today's conference call contain or may contain forward-looking statements covered by the State Farm provisions of of the Private Security Litigation Reform Act of 1995 and applicable federal securities laws. These statements include statements regarding RenovoRx's Rx's clinical and commercial plans, strategies, and estimates or expectations of financial results, including revenue and operational performance are based on management's current plans and assumptions and actual results may differ materially. Please refer to our filings with the SEC, including our Form 10-Q for the quarter end of March 31st, 2026 for a detailed discussion of the risks and uncertainties facing RenovoRx. With that, I'd like to turn the call over to our Chief Executive Officer, Shaun Bagai. Shaun R. Bagai: Thank you, Valter, and good afternoon, everyone. When we spoke with you in late March, we told you that Q1 26 would be our strongest revenue quarter yet. Today, I am pleased to confirm that we delivered on that commitment. Our first quarter results mark an important inflection point for RenovoRx. We are no longer outlining a strategy, We are now executing it. For the first quarter ended March 31, 2026, we generated revenue of $563 thousand our highest quarterly revenue to date. This represents approximately 136% growth quarter over quarter compared to Q4 25 revenue of $238 thousand. More than doubling our revenue in just a single quarter. Just as important, Q1 26 alone accounts for more than half or approximately 51% of our total 2025 revenue of $1.1 million. This is not a coincidence. It is a direct result of deliberate commercial execution driven by the continued expansion of active cancer centers using our RenovoCath device. Exactly as we previously outlined. Based on the m…Read full document

Image source: The Motley Fool. Thursday, May 14, 2026, at 4:30 p.m. ET Chief Executive Officer — Shaun R. Bagai Chief Medical Officer and Executive Chair — Ramtin Agah, M.D. Chief Financial Officer — Mark Voll Valter Pinto: Thank you, Operator. Good afternoon, everyone, and welcome to the RenovoRx first quarter 2026 earnings conference call. I'm joined today by members of our leadership team, including Dr. Ramtin Agah, Chief Medical Officer and Executive Chair, Shaun Bagai, Chief Executive Officer, and Mark Ball, Chief Financial Officer. Before we begin, I'd like to remind everyone that statements made during today's conference call contain or may contain forward-looking statements covered by the State Farm provisions of of the Private Security Litigation Reform Act of 1995 and applicable federal securities laws. These statements include statements regarding RenovoRx's Rx's clinical and commercial plans, strategies, and estimates or expectations of financial results, including revenue and operational performance are based on management's current plans and assumptions and actual results may differ materially. Please refer to our filings with the SEC, including our Form 10-Q for the quarter end of March 31st, 2026 for a detailed discussion of the risks and uncertainties facing RenovoRx. With that, I'd like to turn the call over to our Chief Executive Officer, Shaun Bagai. Shaun R. Bagai: Thank you, Valter, and good afternoon, everyone. When we spoke with you in late March, we told you that Q1 26 would be our strongest revenue quarter yet. Today, I am pleased to confirm that we delivered on that commitment. Our first quarter results mark an important inflection point for RenovoRx. We are no longer outlining a strategy, We are now executing it. For the first quarter ended March 31, 2026, we generated revenue of $563 thousand our highest quarterly revenue to date. This represents approximately 136% growth quarter over quarter compared to Q4 25 revenue of $238 thousand. More than doubling our revenue in just a single quarter. Just as important, Q1 26 alone accounts for more than half or approximately 51% of our total 2025 revenue of $1.1 million. This is not a coincidence. It is a direct result of deliberate commercial execution driven by the continued expansion of active cancer centers using our RenovoCath device. Exactly as we previously outlined. Based on the momentum we are seeing across our commercial footprint, we expect second quarter 26 revenue to exceed our first quarter revenue. Keeping us nicely on track for our expected 2026 revenue target in the $3 million to $4 million range. The growth we have built is real, measurable, and growing with each additional active commercial center. Let me walk you through what is driving this commercial momentum and growth. Our commercial model is straightforward and highly scalable. As more centers approve purchase of the device and become active customers, momentum increases with additional transarterial micro-perfusion microperfusion or TAMP procedures using RenovoCath. This rise in TAMP procedures leads to greater revenue growth Keeping in mind, RenovoCath is a single use device, and each patient undergoes several TAMP procedures. The expansion of our active cancer centers and procedures is the clearest indicator of that trajectory. One of the key lessons we learned in 2025 was the time it takes for a center to approve the use of RenovoCath and then for a center to order devices and schedule procedures. We are now beginning to apply these lessons with positive effect. We began 2025 with 5 active commercial cancer centers And by the year end, we had grown to 8. As of May 2026, we had 16 active commercial centers. We define an active center as a center actively treating patients. Currently, we have 32 additional centers in various stages of evaluation of approval, or activation. In total, these 48 centers represent a quadrupling of our near term pipeline, compared to the 2025 level. As you may recall from our last conference call, our objective is to have 36 centers online and ordering by the end of this year. And our pipeline provides us with the capacity to meet this goal. So that is revenue and customer growth, but I also want to speak to the quality of this growth. We are seeing strong repeat ordering behavior from existing customers which we view as a clear reflection of physician satisfaction, and utility for TAMP and RenovoCath in the interventional oncology market. That is a kind of recurring organic physician driven adoption is critical. And reflects real world validation that we are building durable long term commercial growth. Our pipeline of prospective cancer centers remains robust. With active value analysis committee or VAC submissions underway across a number of leading institutions. Importantly, we see up to 15 active TIGER PACK phase 3 trial sites that have used Renovacast in the trial and are already transitioning to commercial clinical use. We expect these conversions to serve as a meaningful revenue driver in the second half of 2026. Separately, I am pleased to share that RenovoRx was recently recognized by Fast Company as 1 of its world's most innovative companies of 2026 in the medical devices category. This acknowledgment reflects broader recognition of our team and dedication to innovation. Turning to our commercial infrastructure, this is where innovation translates into execution. Our relatively small capital efficient, but agile and motivated commercial team is in place and delivering. Their focus is clear, and the plan is working. I will not spend time on team composition today as results speak for themselves. What I will highlight is the growing level of physician to physician advocacy which has been the most powerful driver of adoption in interventional oncology. Since receiving an initial FDA 510(k) clearance in 2014, Renovacath has been used in more than 750 successful procedures. We are building this commercial franchise in a disciplined, systematic way, and our Q1 results demonstrate that the model is validated and scaling. With that, I will turn the call over to our chief medical officer, executive chair, Dr. Ramtin Agah. Ramtin Agah: Thank you, Sean, and good afternoon, everyone. Let me briefly remind everyone what is the scientific core of what we are building and why it matters. Our patented TAMP therapy platform is designed to deliver targeted chemotherapy through the arterial wall near the tumor site. Designed to bathe the target tumor at a local level while potentially minimizing its therapy toxicity versus systemic intravenous therapy. This approach concentrates drug delivery at the tumor while potentially reducing exposure and the significant toxicities that often accompany conventional intravenous chemotherapy. For patients diagnosed with difficult to treat cancers, or also managing the debilitating side effects of treatment, TAM can represent a critical and differentiated potential treatment option. Our phase 3 TIGER PACT trial continues to advance on schedule. Based on current projections, we expect to send notifications of closure of enrollment in the trial in June. Completing a milestone of finishing trial enrollment by June 2026. As of 05/14/2026, we have randomized 106 patients in the trial. Representing approximately 93% of our required 114 patients. And currently, there are 12 enrolled patient induction that allow us to close enrollment by June. 70-4 events have already been observed, after required 86 events for data analysis in the trial. This progress is an important milestone that reflects strong investigator and patient confidence in the program. We continue to anticipate final data in mid to late 2027, and the trial is designed to evaluate the safety and effectiveness of intra arterial GEM, known as IAG, delivered via RenovoCath. Locally advanced pancreatic cancer versus systemic IV chemotherapy. The current standard of care. I want to underscore something important. The completion of TIGER-PACT enrollment directly supports our commercial expansion story and is not separate from it. As trial sites complete enrollment and transition from a research to a commercial footing, they join our growing network of active commercial centers. This is an anticipated and meaningful contributor to our second half of 2026 revenue growth. In parallel, we have also continued to advance broader clinical programs by generating new data to our continuing support of investigator initiated trials. In borderline resectable and metastatic pancreatic cancer. Use of other agents beyond gemcitabine along with use of TAMP in other solid tumors. Registry and IIT studies are capital efficient studies providing meaningful data that may further broaden the application for TAM therapy platform is enabled by RenovoCath. In terms of scientific data, in January 2026, the pharmacokinetic substudy of TIGER-PACT was presented at ASCO GI meeting by a TIGER-PACT investigator from the University of Pittsburgh Medical Center. The abstract offers insight that supports the potential effectiveness of our TAMP therapy platform in LAPC. Abstract concludes that TAMP and IAG resulted in reduced systemic levels of gemcitabine and increased levels of its inactive metabolite compared with IV gemcitabine. The full paper is submitted for publication later this year. Clinical data builds physician confidence. Physician confidence drives adoption, and adoption drives revenue. RenovoRx commercial progress has become the main focus of our story. While the phase 3 clinical trial remains a vital long term value contributor offering the potential to further accelerate clinical adoption and expand the broader reimbursement landscape our current operations are not tied to this timeline. RenovoRx commercial achievements stand independently and we believe our Q1 26 results clearly reflect this strength. I am excited about where this company stands today and our progress. We are building a company with both near-term execution and long term upside, and I believe we are still in the early stages of that growth trajectory. Thank you for your interest in RenovoRx. With that, I will turn the call over to our chief financial officer, Mark Voll. Mark Voll: Thank you, Ramtin, and good afternoon, everyone. Q1 2026 was RenovoRx strongest quarter for revenue to date and the financial results reflect meaningful progress in implementing our commercial plan. Let me walk you through the financial results for the quarter. For the first quarter ended March 31, 2026, RenovoRx reported revenue of $563 thousand our strongest quarter to date, representing an approximately 136% growth versus 2025 revenue of $238 thousand. The $323 thousand of sequential increase from Q4 to Q1 is a direct result of active commercial cancer center expansion and the commercial infrastructure we have built. On a year over year basis, this compares to revenue of $197 thousand in 2025. Revenue growth was driven by the addition of 5 new active commercial cancer centers during the quarter. Combined with continued repeat ordering from our existing customer base, precisely the dynamics our model is designed to generate. Gross profit for Q1 2026 was $479 thousand representing gross margin of 85.1%. Research and development expenses for Q1 2026 were $1.2 million, reflecting our continued investment in Phase III TIGER-PACT trial and our post marketing registry study. Our first quarter research and development was positively impacted by receipts of $141 thousand from our TIGER-PACT clinical study. Selling, general, and administrative expenses for Q1 2026 were approximately $2.7 million, reflecting disciplined cost management as our commercial infrastructure executes against the plan. Our operating expenses for the quarter were generally in line with our forecast, Research and development spending came in below expectations while and general and administrative expenses were slightly above projections. In both cases, we believe the variances reflect timing differences in when costs were incurred rather than changes in underlying spending pattern. During the first quarter, we successfully closed an oversubscribed private placement. Generating approximately $10 million in gross proceeds an outcome that reflects strong investor demand and confidence in our story. The financing was led by high quality group of new and existing institutional investors with additional participation from members of our board of directors and senior management. Further underscoring our alignment with shareholders and conviction in RenovoRx long term opportunity. As of 03/31/2026, RenovoRx had approximately $12.4 million in cash and cash equivalents. This reflects the net proceeds from our $10 million private placement that closed in March. Our cash position provides sufficient runway to fund operations into 2027. As we work towards cash-flow-positive operations. Our focus now is on revenue generation as we move towards conclusion of our pivotal phase 3 trial. As revenue scales and our active commercial cancer center count grows, cash burn continues to decline. The path towards key milestones TIGER-PACT readout, and commercial breakeven is well funded. We will be opportunistic if capital markets conditions are favorable but fine-grained fundraising is not our focus today. We are reiterating our full year 2026 revenue guidance of $3 million to $4 million and we remain on track to meet this target. Consistent with what I have said before, we are transitioning to a growth company. I spent my career working with high growth companies specifically companies that have had proven their product works and are now focused on building a commercial engine to scale. This is exactly where RenovoRx is today. There is meaningful difference between a company still searching for a marketable product or a market fit and 1 that has. RenovoRx has it, and we are executing. As Sean had stated earlier, our second quarter revenue is tracking well which gives us confidence in stating we believe it will surpass our first quarter revenue. With 16 active commercial cancer centers as of today, and a robust pipeline of centers preparing to come online, the directional trend is clear. As TIGER-PACT clinical sites continue transitioning to commercial centers, we expect that activity to contribute meaningfully to our revenue growth. Our primary commercial KPI remains active commercial cancer center count. We are at 16 active centers today targeting 36 by year end, and the revenue contribution at that level of utilization supports our confidence in our guidance range. In closing, our first quarter is the first in which we clearly demonstrated we are executing on our commercial growth plan we laid out. I look forward to providing further updates as the year progresses. Thank you. I will turn the call back to the operator for Q&A. Operator: Thank you. We will now begin the question and answer session. Please note, for participants making use of speaker equipment, it may be necessary to pick up your handset. Before pressing the star keys. If you would like to ask a question, please key in star and then 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may key in star and then 2 to leave the question queue. Our first question comes from Scott Henry of Alliance Global. Please go ahead. Analyst (Scott Henry): Thank you and good afternoon. Some really positive sales momentum Congratulations for that. Just a couple questions. First, when we think about the profitability of the catheter revenue, it looks like costs went up a little bit in G&A or in Q1. I assume the selling is within the G&A. My question is, is there any noise in there that made it go to $2.7 million? And more importantly, do you think that what you are spending now will be, pretty stable such that as revenues grow even higher, the profitability of the product should really come through. Mark Voll: Thank you. So we see that our operating expenses will we do not see any real increase in operating expenses as we move forward. As we as I had stated during the call, we had some timing differences. So more expenses that we had in Q1 for the SG&A and G&A and less in R&D. That was kind of abnormal. But we do not see any real increase in operating expenses. We believe that we are well suited in operating expense levels as we ramp revenue, so we should start to see our cash burn decrease. As we go throughout the year. So with our model, there is a lot of leverage. As we grow top line, we should see bottom line at least when it comes to losses, decrease and eventually become profitable and that expand from there. Analyst (Scott Henry): Okay. that is great. I appreciate that color. And when we are looking at the revenue numbers, it is early but are you starting to reach a state where the numbers are large enough that the trends will show out as opposed to, you know, some chunkiness a good quarter, and then timing of orders. But are we starting to see more of a steady state where the trend be apparent? Mark Voll: Yeah, we are starting to see that. And the biggest predictor and driver of that is seeing how many centers we are bringing on board. As a future predictor of revenue. Going from 8 to 16 from the end of the year to now, you know, really in 4.5 months, really showing that we should start to see some leveling out of the chunkiness and start to see a substantial growth this year. it is going to be different percentages every quarter probably, but we do see an upwards momentum of revenue in general and not so much, chunkiness in that regard. Analyst (Scott Henry): Okay. Great and then, final question. When we think about the second half, when those clinical sites shift over from clinical to commercial, do you find that their behavior or do you expect that their behavior will be pretty predictable? You know a lot of these sites already. But based on your feedback, do you feel pretty confident that they will flip the switch and to being commercial payers right out of the gate. Ramtin Agah: Yeah. Thanks for asking that question, Scott. Absolutely. We have had dialogues with almost all of them so far. Actually, all of them, and there is a lot of interest and enthusiasm to continue to treat patients given that they have seen how potentially effective and how much better the toxicity profile is for their own patients. So there is definitely interest to continue usage As far as predictability goes, because it is a pancreatic cancer population and locally advanced is where the driver of the initial uses are, and there are other uses We cannot tell you the exact numbers, but given our projections, as Mark had characterized, exiting the year with at least 36 active centers. Operator: The next question comes from Justin Walsh of Jones Trading. Please go ahead. Justin Walsh: Hi. Thanks for taking the questions. As physicians have gained experience with RenovoCath, I'm wondering if you've received feedback on what aspects of the technology have resonated the most. And it would be also great to hear if there are use cases for RenovoCath outside of LAPC that have generated the most interest from investigators? Shaun Bagai: Thanks for the question, Justin. So the physicians really are looking at the side effect profile as the largest driver. They've seen, after treating patients for decades with current standard of care therapies, and even looking to potential future technologies or therapies that are coming out, they've seen these patients get beat up with systemic therapy, and they simply can't tolerate something beyond a few months or several months. And so they're looking forward to the characteristic of the toxicity profile being number one. Number two, the confidence that it's not gonna reduce their lifespans. And number three, the hope that it'll actually increase their lifespans based on early data. So there's several drivers to why they believe that this could be a great choice for their patients. From a use case perspective, the primary experience we've had to date in trials has been Locally Advanced Pancreatic Cancer. And again, that's for the purpose of the clinical trial. But it doesn't stop there. There's a strong level of interest. In fact, there are two IITs right now that we've greenlighted that are in the process of getting launched at Moffitt Cancer Center, University of Vermont, looking at metastatic pancreatic cancer patients and even earlier stage cancer, looking at resectable or borderline resectable patients at Moffitt and Vermont, respectively. Beyond that, other tumors where they have issues trying to get drug to the tissue because they don't have a large blood supply is a big area of interest. Namely, biliary tumors or cholangiocarcinoma is an area of interest next. Beyond that, non-small cell lung cancer, some pelvic tumors, and even sarcomas given the vascularity nature of those types of tumors. So there are several tumor types so there's interest in using the technology either commercially and with investigators in the trials. Justin Walsh:  Great, thanks for taking the questions. Thank you, Justin. Operator: The next question comes from Ed Hu of Ascendiant Capital Markets. Please go ahead. Ed Hu: Yeah, congratulations on all the progress that you guys are doing on both fronts. My question is on RenovoCath. Do you have to spend much R&D to develop it or is it an ongoing process where you need to continue to make upgrades to it going forward? Shaun Bagai: Well, thanks for the question, Ed. You know, it's interesting. My whole career is spent in innovative medical technologies. It's rare when you get to launch a technology with something that's really close to the same design as you started off with. And what's amazing is the technology seems to be working quite well and is user friendly enough that it's relatively similar design. So it has not taken, will not take large R&D efforts. Having said that, there are optimizations that we've been working on that we will bring out in the next year or two. That involve really streamlining the manufacturing process for full market scalability beyond even initial penetration. And which will really reduce the cogs of the catheter even further. And which is amazing because we already have very high margins. Beyond that, we'll continue to explore if there are other minor aspects that could add to the technology of the device to help make the procedure more predictable or easier to use, but not large R&D efforts. And we don't need any of these changes really to penetrate the full market. These are just more optimizations. Ed Hu: Well, that's great to hear. Thanks for answering my question and I wish you guys good luck. Shaun Bagai: Thank you. Thank you, Ed. Operator: Well, ladies and gentlemen, we have reached the end of the question and answer session. This concludes today's conference call. Thank you for your participation and you may now disconnect your lines. 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Investor releaseQuarter not tagged2026-05-15

RenovoRx Reports Record First Quarter 2026: Increasing Revenue by 136% Quarter-over-Quarter

GlobeNewswire
Q1 2026 Revenue of $563,000 Totals Over 50% of Full Year 2025 Total Revenue Active Commercial Cancer Center Customers Expand to 16 with Growing Sales Pipeline, Accelerating Adoption of the TAMP™ Therapy Platform Enabled by the RenovoCath® Device Phase III TIGeR-PaC Trial Advances Toward Completion with Full Enrollment Expected in June 2026 Ended First Quarter with $12.4 million in cash, Sufficient to Fund Operations into at Least the Second Half of 2027 Management to Host Conference Call Today at 4:30 P.M. ET MOUNTAIN VIEW, Calif., May 14, 2026 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, FDA-cleared drug-delivery device, today announced its financial results for the first quarter ended March 31, 2026, and is providing shareholders with a business update. “We made important strides in the first quarter of 2026 with strong commercial adoption of the TAMP platform enabled by RenovoCath, resulting in record quarterly revenue exceeding 50% of the revenue we generated in all of 2025,” said Shaun Bagai, Chief Executive Officer of RenovoRx. “We generated Q1 revenue of $563,000, an increase of 136% compared to the fourth quarter of 2025, mainly driven by the growing number of active cancer centers and rising procedural utilization across our existing customer base. Additionally, we ended the quarter with $12.4 million in cash, which, we believe, is sufficient to fund our operations into at least the second half of 2027. With a solid sales pipeline, we are confident in sustaining growth as our business scales.” “Our commercial momentum is being driven by our focused and scalable expansion strategy into cancer centers,” continued Mr. Bagai. “We have grown from 5 active commercial cancer center customers at the beginning of 2025 to 16 today, with 32 additional centers progressing through stages of evaluation, approval, and onboarding. Notably, we are seeing meaningful repeat utilization across our existing centers, which we believe reflects growing physician confidence and clinical utility. As we expand our footprint and deepen utilization, we believe that RenovoRx is building a durable commercial foundation with the potential for predictable, recurring revenue growth.” “Looking ahead, we remain focused on executing…Read full document

Q1 2026 Revenue of $563,000 Totals Over 50% of Full Year 2025 Total Revenue Active Commercial Cancer Center Customers Expand to 16 with Growing Sales Pipeline, Accelerating Adoption of the TAMP™ Therapy Platform Enabled by the RenovoCath® Device Phase III TIGeR-PaC Trial Advances Toward Completion with Full Enrollment Expected in June 2026 Ended First Quarter with $12.4 million in cash, Sufficient to Fund Operations into at Least the Second Half of 2027 Management to Host Conference Call Today at 4:30 P.M. ET MOUNTAIN VIEW, Calif., May 14, 2026 (GLOBE NEWSWIRE) -- RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a life-sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a patented, FDA-cleared drug-delivery device, today announced its financial results for the first quarter ended March 31, 2026, and is providing shareholders with a business update. “We made important strides in the first quarter of 2026 with strong commercial adoption of the TAMP platform enabled by RenovoCath, resulting in record quarterly revenue exceeding 50% of the revenue we generated in all of 2025,” said Shaun Bagai, Chief Executive Officer of RenovoRx. “We generated Q1 revenue of $563,000, an increase of 136% compared to the fourth quarter of 2025, mainly driven by the growing number of active cancer centers and rising procedural utilization across our existing customer base. Additionally, we ended the quarter with $12.4 million in cash, which, we believe, is sufficient to fund our operations into at least the second half of 2027. With a solid sales pipeline, we are confident in sustaining growth as our business scales.” “Our commercial momentum is being driven by our focused and scalable expansion strategy into cancer centers,” continued Mr. Bagai. “We have grown from 5 active commercial cancer center customers at the beginning of 2025 to 16 today, with 32 additional centers progressing through stages of evaluation, approval, and onboarding. Notably, we are seeing meaningful repeat utilization across our existing centers, which we believe reflects growing physician confidence and clinical utility. As we expand our footprint and deepen utilization, we believe that RenovoRx is building a durable commercial foundation with the potential for predictable, recurring revenue growth.” “Looking ahead, we remain focused on executing against both our near-term commercial priorities and our long-term clinical objectives,” added Mr. Bagai. “We expect continued revenue growth throughout 2026, supported by ongoing cancer center activations and continued transition of Phase III TIGeR-PaC trial sites into commercial centers after full enrollment is complete. At the same time, TIGeR-PaC remains on track for complete enrollment in June 2026, reinforcing the strength of our dual-track strategy. With a strengthened balance sheet and growing commercial traction, we believe RenovoRx is well positioned to deliver meaningful value creation in the quarters ahead and continue to expand access to life-changing care for patients battling difficult-to-treat cancers.” RenovoCath Commercialization Update RenovoRx saw further acceleration in the commercial rollout of RenovoCath during the first quarter of 2026, achieving its strongest quarterly revenue performance to date. Revenue totaled $563,000 for the quarter, representing a 136% quarter-over-quarter increase compared to the fourth quarter of 2025 and totaling more than 50% of the Company’s total revenue generated in 2025. This significant growth reflects continued expansion of active commercial cancer centers and increasing procedural utilization of RenovoCath across the Company’s installed base. The Company defines "active" commercial cancer centers as centers where doctors are actively treating patients with RenovoCath. RenovoRx's commercial model remains centered on active cancer center expansion, with additional centers driving increased procedures and revenue growth. RenovoRx began 2025 with 5 active commercial cancer centers, and by end of the year, we had grown to 8. As of May 6, 2026 we had 16 active centers. RenovoRx is also advancing a robust pipeline of 32 additional centers in various stages of evaluation, approval, and onboarding, representing a significant expansion of its near-term commercial footprint. In total, these 48 centers have approximately quadrupled the Company’s near-term commercial sales pipeline compared to the first quarter of 2025, reflecting the rapid expansion of RenovoRx’s commercial footprint year-over-year. Up to 15 TIGeR-PaC Phase III clinical trial sites that have previously utilized RenovoCath are expected to continue transitioning to commercial clinical use following completion of trial enrollment. These anticipated conversions represent a meaningful opportunity to drive incremental revenue growth in the second half of 2026. The Company continues to target 36 active commercial cancer centers by year-end 2026. RenovoRx continues to observe organic repeat ordering behavior from existing customers, which the Company views as a key indicator of physician satisfaction and clinical utility. As physicians incorporate RenovoCath into routine clinical practice, repeat utilization is expected to drive sustained and compounding revenue growth. The combination of record quarterly revenue, rapid active cancer center expansion, and strong repeat ordering behavior demonstrates accelerating commercial momentum and supports the long-term opportunity for RenovoCath as both a standalone device and a foundational platform for future drug-device combination therapies. RenovoRx continues to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an approximately $400 million peak annual U.S. sales opportunity, with long-term, several-billion-dollar potential as the platform expands into additional solid tumor indications. Clinical Research and Scientific Programs Advancement of the ongoing Phase III TIGeR-PaC clinical trial evaluating intra-arterial delivery of gemcitabine (IAG) via the RenovoCath device for the treatment of locally advanced pancreatic cancer (LAPC) continued in the first quarter of 2026. Based on current projections, RenovoRx expects to send notification of closure of enrollment in the trial in the beginning of June, completing the Company's milestone of finishing trial enrollment by the end of June 2026. As of May 14, 2026, 106 patients had been randomized in the trial, representing approximately 93% of the required 114 patients, and currently there are 12 enrolled patients in induction, which gives rise to the expectation that enrollment will be closed by the end of June. Seventy-four events (i.e., patient deaths) have been observed of the 86 events required to trigger the final analysis. The Company continues to anticipate final data in mid to late 2027. During the first quarter of 2026, RenovoRx continued to execute on key operational priorities for TIGeR-PaC, including patient enrollment, site engagement, and maintaining protocol adherence across its clinical network. These efforts build on the successful completion of the second interim analysis in 2025, after which the independent Data Monitoring Committee recommended continuation of the trial without modification. In alignment with standard clinical trial practices and to preserve trial integrity, the Company has elected to defer publication of interim data until study completion. RenovoRx expects that TIGeR-PaC trial sites will continue transitioning to commercial use following completion of enrollment, representing a meaningful potential driver of revenue growth in the second half of 2026. RenovoRx continues to view the TIGeR-PaC trial as an important long-term value driver, while emphasizing that its current commercial strategy is independent of the trial’s ultimate outcome and timeline. RenovoRx continues to advance broader clinical programs by generating new data through the Company’s continued support of investigator-initiated trials (IIT) in borderline resectable and metastatic pancreatic cancer, use of other agents beyond gemcitabine (the chemotherapy being used in TIGeR-PaC), and use of TAMP in other solid tumors. Registry and IIT studies are capital-efficient studies providing meaningful data that may further broaden the application for the TAMP therapy platform which is enabled by RenovoCath. In terms of scientific data, in January 2026, a pharmacokinetic subset study of the TIGeR-PaC trial was presented at the 2026 ASCO Gastrointestinal (GI) Cancers Symposium by a TIGeR-PaC Investigator from the University of Pittsburgh Medical Center. The abstract offers insight that supports the potential effectiveness of the TAMP therapy platform in LAPC. The abstract concludes that TAMP and IAG resulted in reduced systemic levels of gemcitabine and increased levels of its inactive metabolite compared with IV gemcitabine. A full paper is submitted for publication later this year. First Quarter 2026 and Subsequent Key Highlights RenovoRx continued to execute on its dual clinical and commercial strategy during the first quarter of 2026, leveraging the operational foundation established in 2025 to drive measurable commercial progress. The Company’s lean commercial infrastructure is now actively supporting cancer center expansion and revenue growth, while physician-to-physician advocacy and real-world clinical experience continue to drive adoption. Since receiving FDA 510(k) clearance in 2014, RenovoCath has been used in 750 successful procedures, underscoring the device’s growing clinical utility and physician acceptance. The Company was also bestowed with external recognition for its innovation, being named one of Fast Company’s “World’s Most Innovative Companies of 2026,” in the Medical Devices category. During the first quarter of 2026, RenovoRx strengthened its balance sheet through the successful completion of an oversubscribed private placement, generating approximately $10 million in gross proceeds. The financing reflects strong institutional investor demand and supports the Company’s ongoing clinical development and commercial expansion initiatives. Proceeds are expected to be used for working capital and general corporate purposes, providing additional flexibility as RenovoRx continues to scale its operations and advance its growth strategy. Financial Highlights for the First Quarter Ended March 31, 2026 Revenue for the three months ended March 31, 2026 was $563,000, compared to $197,000, year-over-year. The increase was driven by acceleration in the continued commercialization of RenovoCath and expanding adoption across U.S. cancer centers. Research and development expenses were approximately $1.2 million for the three months ended March 31, 2026, compared to approximately $1.6 million year-over-year. The decrease was primarily driven by higher receipts received from the TIGeR-PaC clinical trial. Selling, general and administrative expenses were approximately $2.7 million for the three months ended March 31, 2026, compared to approximately $1.6 million year-over-year, a reflection of the Company’s continued execution on its commercial infrastructure strategy. Net loss for the quarter ended March 31, 2026 was approximately $3.5 million, compared to approximately $2.4 million for the quarter ended March 31, 2025. Cash and cash equivalents were approximately $12.4 million as of March 31, 2026. During the first quarter, the Company strengthened its balance sheet with approximately $10 million in gross proceeds from a March 2026 private placement financing. The Company believes its current cash resources are sufficient to fund operations into at least the second half of 2027. Shares Outstanding: As of March 31, 2026, common shares outstanding totaled 45.05 million. Guidance: Reiterating full year 2026 revenue guidance of $3 to $4 million. For interested individuals unable to join the conference call, a link to the recording will be available on RenovoRx’s Investor Relations website, and a dial-in replay will be available until May 28, 2026 and can be accessed by dialing 1-844-512-2921 (U.S. Toll Free) or 1-412-317-6671 (International) and entering replay pin number 13760238. 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 select 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.-G-Universal-IFU.pdf. About RenovoRx, Inc. RenovoRx, Inc. (Nasdaq: RNXT) is a life sciences company developing innovative targeted oncology therapies and commercializing RenovoCath®, a novel, U.S. Food and Drug Administration (FDA)-cleared local drug-delivery device, targeting high unmet medical needs. RenovoRx’s patented Trans-Arterial Micro-Perfusion (TAMP™) therapy platform is designed for targeted therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy, and its mission is to transform the lives of cancer patients by providing innovative solutions to enable targeted delivery of diagnostic and therapeutic agents. RenovoRx is in the early stages of commercializing its TAMP technology and FDA-cleared RenovoCath as a stand-alone device. In its first full year of commercial efforts, RenovoRx generated approximately $1.1 million in RenovoCath sales and learned valuable lessons that will help drive growth in 2026 and beyond. Several customers have already initiated repeat orders and the number of medical institutions initiating new RenovoCath orders is expanding, 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. RenovoRx is also evaluating its novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. IAG utilizes RenovoCath, the Company’s patented, FDA-cleared drug-delivery device, indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The IAG combination product candidate, which is enabled by the RenovoCath device, 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 seven years of market exclusivity upon new drug application approval by the FDA. For more information, visit www.renovorx.com. Follow RenovoRx on Facebook, LinkedIn, and X. Non-GAAP Financial Measures In addition to reporting financial results in accordance with U.S. generally accepted accounting principles (“GAAP”), the operating results presented in the accompanying tables include certain non-GAAP financial measures that exclude the non-cash expense associated with share-based compensation. We are providing such non-GAAP financial information in this press release, including non-GAAP operating expenses, net income (loss), and earnings (loss) per share, as a supplement to our consolidated financial statements prepared in accordance with GAAP which appear in this press release and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 as filed with the U.S. Securities and Exchange Commission. Our management uses these non-GAAP measures internally to analyze financial results, evaluate operational performance, and assess liquidity. We believe that both management and investors benefit from referring to these non-GAAP measures when assessing performance and when planning, forecasting, and analyzing future periods. We believe these non-GAAP measures also enhance investors’ understanding of key financial metrics used in operational decision-making and are useful for comparing our performance to that of other companies. However, readers are cautioned that non-GAAP results are presented for supplemental information purposes only and should not be considered a substitute for GAAP financial information. These measures may differ from similarly titled non-GAAP measures presented by other companies. Moreover, non-GAAP financial measures are not required to be uniformly applied and are not audited. Cautionary Note Regarding Forward-Looking Statements This press release 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 clinical trials and studies, (ii) the potential for our product candidates to treat or provide clinically meaningful outcomes for certain medical conditions or diseases, and (iii) our efforts to commercialize our RenovoCath and 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, 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 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,” “expected,” “plans,” “aims,” “anticipates,” “believes,” "aim," "goal," “forecasts,” “estimates,” “intends,” “potential,” “milestone” and “towards” or derivatives 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 exploration of commercial opportunities for our TAMP technology may not lead to viable, 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 our 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 customer 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. Investor Contact: KCSA Strategic Communications Valter Pinto or Jack Perkins T: 212-896-1254 [email protected]

Investor releaseQuarter not tagged2026-05-15

RenovoRx, Inc. Q1 2026 Earnings Call Summary

Moby
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved record quarterly revenue of $563,000 in Q1 2026, representing a 136% sequential increase and more than half of the total revenue generated in fiscal year 2025. Transitioned from strategic planning to active execution, driven by the expansion of active commercial cancer centers from 8 at year-end 2025 to 16 as of May 2026. Validated the commercial model through strong repeat order behavior, which management views as a direct reflection of physician satisfaction and the clinical utility of the RenovoCath device. Leveraged a capital-efficient commercial infrastructure that relies on physician-to-physician advocacy as the primary driver for adoption in the interventional oncology market. Attributed growth to the scalability of the Trans-Arterial Micro-Perfusion (TAMP) procedure, where each patient requires multiple single-use RenovoCath devices. Maintained high gross margins of 85.1%, reflecting a disciplined approach to commercializing the existing patented therapy platform. Reiterated full-year 2026 revenue guidance of $3 million to $4 million, with Q2 revenue expected to surpass Q1 levels based on current tracking. Targeting 36 active commercial centers by the end of 2026, supported by a pipeline of 32 additional centers currently in evaluation or approval stages. Anticipate closing enrollment for the Phase III TIGeR-PaC trial by the end of June 2026, with final data readout projected for mid-to-late 2027. Expect a meaningful revenue contribution in the second half of 2026 as up to 15 TIGeR-PaC clinical trial sites transition into active commercial customers. Projected cash runway is sufficient to fund operations into the second half of 2027, with a strategic focus on reaching cash flow positive operations as revenue scales. Closed an oversubscribed $10 million private placement in March 2026, strengthening the balance sheet to $12.4 million in cash and cash equivalents. Reported R&D expenses were offset by a $141,000 receipt related to the TIGeR-PaC clinical study, while SG&A variances were attributed to timing rather than structural spending changes. Recognized by Fast Company as one of the world's most innovative companies of 2026 in the medical devices category, enhancing brand credibility during…Read full document

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Achieved record quarterly revenue of $563,000 in Q1 2026, representing a 136% sequential increase and more than half of the total revenue generated in fiscal year 2025. Transitioned from strategic planning to active execution, driven by the expansion of active commercial cancer centers from 8 at year-end 2025 to 16 as of May 2026. Validated the commercial model through strong repeat order behavior, which management views as a direct reflection of physician satisfaction and the clinical utility of the RenovoCath device. Leveraged a capital-efficient commercial infrastructure that relies on physician-to-physician advocacy as the primary driver for adoption in the interventional oncology market. Attributed growth to the scalability of the Trans-Arterial Micro-Perfusion (TAMP) procedure, where each patient requires multiple single-use RenovoCath devices. Maintained high gross margins of 85.1%, reflecting a disciplined approach to commercializing the existing patented therapy platform. Reiterated full-year 2026 revenue guidance of $3 million to $4 million, with Q2 revenue expected to surpass Q1 levels based on current tracking. Targeting 36 active commercial centers by the end of 2026, supported by a pipeline of 32 additional centers currently in evaluation or approval stages. Anticipate closing enrollment for the Phase III TIGeR-PaC trial by the end of June 2026, with final data readout projected for mid-to-late 2027. Expect a meaningful revenue contribution in the second half of 2026 as up to 15 TIGeR-PaC clinical trial sites transition into active commercial customers. Projected cash runway is sufficient to fund operations into the second half of 2027, with a strategic focus on reaching cash flow positive operations as revenue scales. Closed an oversubscribed $10 million private placement in March 2026, strengthening the balance sheet to $12.4 million in cash and cash equivalents. Reported R&D expenses were offset by a $141,000 receipt related to the TIGeR-PaC clinical study, while SG&A variances were attributed to timing rather than structural spending changes. Recognized by Fast Company as one of the world's most innovative companies of 2026 in the medical devices category, enhancing brand credibility during the commercial ramp. Identified potential for future margin expansion through manufacturing optimizations intended to further reduce the cost of goods sold for the RenovoCath device. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management expects operating expenses to remain relatively stable even as revenue ramps, creating significant financial leverage. The company anticipates cash burn will decrease throughout the year as they move toward commercial break-even. Management expressed high confidence in the transition, noting that clinical sites have already seen the toxicity profile benefits firsthand. Commercial volume at these sites may exceed trial volume because the commercial market includes patients who have already failed systemic chemotherapy, a group excluded from the strict trial criteria. Physicians are primarily adopting the technology due to its reduced toxicity profile compared to systemic intravenous therapy. Beyond pancreatic cancer, the company is seeing investigator interest in biliary tumors, non-small cell lung cancer, and sarcomas. The current device design is considered highly effective and user-friendly, requiring no major R&D changes for full market penetration. Future R&D will focus on manufacturing optimizations to improve scalability and further reduce costs over the next one to two years.

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook