RenovoRx, Inc. (NASDAQ: RNXT) shares traded lower after reporting earnings; that's not uncommon in this day of "selling the news" mentality. But while a popular strategy in situations where investors expect price weakness from a lightening of the news queue, those selling RNXT on Thursday appeared to come running back on Friday, likely after digesting critical aspects of the release highlighting that several potentially transformative announcements are in play. One as early as days from now, and that expectation helped send shares nearly 6% higher to close Friday at $5.20
Thus, the initial profit taking on Thursday after an over 117% YTD run, while understandable, proved risky to those wanting to hold positions with the thought of buying back at a lower price. Not only that, but the tax ramifications from a quick flip could wipe out any expected savings. Moreover, with Friday's closing price at its high level of the day, the chase from a technical place could continue on Monday.
One thing is for sure: investors bullish about RNXT before its earnings release should be more so now. Not because of the company's solid financial position, per se, but because RNXT reiterated that updates from its late-stage Phase III trial are imminent.
Potential Clinical Trial Catalysts Imminent
The more excellent news is that with precedent indicating the results will likely confirm prior ones, the update could steepen an already bullish trajectory for the company. In fact, those wishing for a better entry point in RNXT after missing its February rally may want to consider acting sooner than later. After all, given that the biggest news in the company's history related to bringing to market a better way to treat cancers and solid tumors is now just days away, jockeying for a position may be a risky proposition.
Sure, RNXT shares could trade lower ahead of the data release. But, knowing that investors historically pay a considerable premium to take a position in phase III companies - even those just reaching that milestone - the current $5.20 price may be a bargain too good to ignore. Don't forget, RNXT won't be updating a Phase I/II trial; they'll be releasing interim data from its Phase III TIGeR-PaC trial as well as providing additional updates about its drug development pipeline. There's plenty to be excited about.
Foremost is that RenovoRx is finalizing the interim analysis and plans to release those results "within the next week or so." A calendar indicates that the drop will happen before March 10th, accounting for an extra day for the "or so" part of its statement.
A Potentially Transformative Moment In The Queue
Of course, RNXT must deliver as expected, and precedent suggests they can. So far, 47 out of 114 target post-SBRT/chemotherapy patients have been randomized in the TIGeR-PaC clinical trial, and RNXT has received reports of 26 events (deaths) in this population. This 26th event represents 30% of the 86 events and thus triggered the first planned interim analysis and a meeting of the study's Data Monitoring Committee ("DMC") to evaluate the ongoing progression of the Phase III clinical trial. Upon completion of the analysis and assessment of the data by the DMC, and RenovoRx's subsequent review of their findings, it will report the first interim analysis.
About the trial, TIGeR-PaC is a randomized multi-center Phase III open-label clinical trial designed to investigate RenovoRx's first product candidate, RenovoGemTM, which utilizes RenovoRx's proprietary therapy platform, RenovoTAMP®, to provide targeted intra-arterial delivery of FDA-approved chemotherapy, gemcitabine, to treat locally advanced pancreatic cancer (LAPC) following stereotactic body radiation therapy (SBRT).
Contributing to trial endpoints, the study compares treatment with RenovoTAMP versus standard-of-care systemic intravenous (IV) administration of gemcitabine and nab-paclitaxel. The study is designed to randomize 114 patients (57 in each arm), all receiving upfront induction chemotherapy and SBRT. The final analysis will be conducted after 86 protocol-specified events have occurred in the SBRT population with two planned interim analyses: the first analysis when 30% of the specified events have been reported (triggering the forthcoming data announcement) and the second analysis when 60% of the events have been reported, which is expected to happen in 2024.
If all goes as planned, the innovative RenovoRx therapy platform would disrupt the current standard of care and cause a potential changing of the guard at the front-line position, usurping big pharma names like Merck (NYSE: MRK) and Incyte (NASDAQ: INCY). RNXT has an excellent shot of earning that role by advancing a mission to transform oncology therapy with its TIGeR-PaC Phase III study, treating pancreatic cancer, and expanding its clinical pipeline to treat other solid tumors. In supporting the progress, RNXT has strengthened its internal team, with the ultimate goal of giving its patients more quality time to spend with their loved ones.
Groundwork Laid For Momentum
Leading up to the planned data release, RNXT completed an impressive amount of work in 2022. They announced the Initial Results of the Pharmacokinetic Substudy at the 2023 ASCO Gastrointestinal Cancer Symposium. That data on RenovoGem supports the potential for the RenovoTAMP therapy platform to increase local gemcitabine delivery and decrease the side effects of pancreatic cancer treatment. The company earned its eighth U.S. patent extending the intellectual property coverage of the RenovoTAMP therapy platform. In addition, and usually a good predictor of outcomes, four clinical data abstracts were accepted for presentation at the 2023 ASCO Gastrointestinal Cancer Symposium.
That's not all. The company also presented its RenovoTAMP therapy platform at the Advanced Interventional Management Symposium as well as the Symposium on Clinical Interventional Oncology. RNXT also participated in the University of Cambridge Academy of Therapeutic Sciences Gateway to Translation Seminar Series, presented preclinical research data demonstrating potential utility for the treatment of bile duct cancer, and enrolled the first pancreatic cancer patient in its ongoing TIGeR-PaC clinical trial study at Columbia University's New York-Presbyterian Hospital Irving Medical Center
Thus, it's fair to suggest that the stage is set for a breakout in 2023. Better still, that move, which for all intents and purposes has already started, could gain steam within three calendar days from now. In other words, with data that could support RNXT advancing to a frontline position to treat cancers and tumors, which brings an estimated $429 million treatment opportunity by 2029, the coming trading days for RNXT could offer a wild ride. But for biotech investors, that won't be anything new. With risk comes reward, even if it can be an erratic drive to the finish line.
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