RenovoRx, Inc. (NASDAQ: RNXT) shares are in bull mode. Since the new year, RNXT stock is trading higher by over 88% to $4.43, decoupling from the broader weakness in the small-cap biotech space. With impressive YTD gains, RXNT is better positioned now than when its stock scored a $5.00 mark last month, and following its latest announcements, is targeting to attack that YTD high.
That bullish presumption is justified as the latest news shows that this clinical-stage biopharmaceutical company is on track to disrupt the current cancer treatment paradigm. That means RNXT isn't intending to follow conventional treatment protocols but is instead blazing its own trail to revolutionize oncology therapy by delivering proprietary innovative and targeted intra-arterial (IA) delivery of chemotherapy directly to solid tumors.
The better news is that its treatment candidates show more than targeted effectiveness. Importantly, its RenovoRx Trans-Arterial Micro-Perfusion (RenovoTAMP®) therapy platform demonstrates the unique ability to avoid the harsh side effects typical of the current standard of care, contributing data supporting improved patient well-being and extension of life. Simply said, RNXT is developing a win-win treatment proposition.
A Better Platform By Design
And that's by design. The company's RenovoTAMP platform is designed to utilize approved chemotherapeutics with validated mechanisms of action and well-established safety and side effect profiles, intending to increase local delivery of the chemotherapeutic while reducing the often-debilitating side effects associated with systemic delivery.
That's an important distinction and a considerable advantage, noting that while the oncology field continues to progress in treating certain cancers, toxicity concerns and limitations of chemotherapy still remain a significant barrier to delivering an adequate standard of care treatment. Remember that the common objective in chemotherapy treatment innovation is to enhance the dosing of the therapeutic while minimizing systemic toxicity. The goal of that objective is to mitigate drawbacks of the current standard of chemotherapeutic care for most cancers, which must deliver chemotherapy throughout the body and, as a result, often causes unintended and severe side effects. RNXT's platform addresses those concerns.
And that's helped to expedite announcing initial results from a pharmacokinetic (PK) substudy within the phase III un-blinded randomized control TIGeR-PaC clinical trial, with those results presented at the 2023 ASCO Gastrointestinal (ASCO GI) Cancers Symposium this week. The TIGeR-PaC clinical trial is evaluating intra-arterial (IA) administration of gemcitabine (chemotherapy) using the proprietary RenovoTAMP platform for targeted treatment of Locally Advanced Pancreatic Cancer (LAPC).
The excellent news so far, beyond targeted effectiveness, is that the substudy provides clinical support that RenovoTAMP may increase local drug delivery and, concentration at the tumor site while decreasing the debilitating side effects often associated with the standard of care systemic intravenous (IV) delivery. That's not all generating optimism.
Phase III Study Ongoing
RNXT's Phase III TIGeR-PaC study is also attracting the right kind of industry attention. It's an un-blinded randomized multi-center trial evaluating using RenovoRx's innovative therapy platform, RenovoTAMP®, with gemcitabine as a potential treatment option for LAPC. The study is evaluating RNXT's flagship candidate RenovoGem™ to treat locally advanced pancreatic cancer following stereotactic body radiation therapy through the intra-arterial delivery of the FDA-approved chemotherapy, gemcitabine.
Specifically, the 114-patient randomized study has a primary endpoint of overall survival and several secondary endpoints, including quality of life. All patients receive stereotactic body radiation therapy and induction chemotherapy, with 57 patients in each arm. The final analysis will be conducted after 86 deaths from the SBRT population, with at least two planned interim analyses, the first upon 30% (26 of 86) of the total and the second upon 60% (52 of 86) of the total. To date, 47 out of 114 target post-SBRT/chemotherapy patients have been randomized in the TIGeR-PaC trial, and RNXT has received reports of 25 events (deaths) in this population.
There are still more studies driving the value behind RNXT.
Evaluating RenovoGem In Phase II/III Study
RenovoRx is advancing plans to study RenovoGem in a Phase II/III CouGAr clinical trial evaluating its use against bile duct cancer (eCCA), a rare and aggressive cancer that forms in bile ducts. Bile ducts are thin tubes carrying digestive fluid, bile, from the liver to other digestive organs. The problem people are facing is that the disease often starts in the bile ducts outside the liver, meaning that most people do not have symptoms until the condition becomes more advanced. Thus, it's often difficult for clinicians to diagnose the disease early. RNXT is well-positioned to expedite getting better treatment to patients.
That position may soon get even stronger. With an Orphan Drug Designation for Cholangiocarcinoma in hand, should RNXT become the first to earn FDA approval for intra-arterial gemcitabine for the treatment of eCCA, they would benefit from seven years of orphan exclusivity to market RenovoGem for the eCCA indication. That can be a transformative moment for RNXT, noting that the market is expected to become a more than $429 million treatment opportunity by 2029. It's a big prize, leading big pharma Merck (NYSE: MRK) and Incyte (NASDAQ: INCY) to enter the race to earn front-line designations.
Still, while mega-cap names are in the competitive landscape, there's room for a dominant leader. RNXT is more than eyeing that opportunity as a stand-alone; interim data in the meantime could fuel outside interests. In other words, don't rule out partnerships or licensing deals along the way. Thus, while the race is on, it's far from over, and winners from the small-cap space are indeed viable contestants. There's more in the value-creating pipeline.
Discovery Phase Adds Pipeline Value
RenovoRx also announced plans to launch preclinical studies to explore the effectiveness of RenovoGem in treating other solid tumors, such as locally advanced lung cancer, uterine tumors, and glioblastoma. Treating those indications puts additional hundred million dollar plus indications in the crosshairs. Remember, even early and preclinical stage studies can yield significant value.
Moreover, companies advancing platforms like RNXT have significantly more upside potential to earn attention from companies needing access to a proven delivery system. Hence, while the above indications are in the Discovery phase, don't rule out RNXT being able to attract some outside interest from companies needing a jump start to gain a competitive advantage.
Keeping in mind the objective of the RenovoTAMP platform, which is to improve the quality of life of patients fighting difficult-to-treat cancers and reducing the debilitating side effects typical of the standard-of-care systemic chemotherapy, RNXT provides a universal tool that has plenty of intrinsic and inherent value.
Thus, discovery and preclinical programs should never be ruled out as value drivers. These programs tend to surprise investors with their inherent value. Often, companies with innovative assets can be a headline away from exposing a potentially significant and revenue-generating deal. Don't rule out that possibility with RNXT. RenovoTAMP has the potential to provide a considerable tailwind in 2023.
A Comprehensive Value Proposition
All told, the best way to appraise the RNXT value proposition is to total the sum of its parts. It has an ongoing phase III trial, a developing Phase II/III trial, and a discovery phase program that combines to target cancer indications with an innovative platform that can change the direction of how many diseases requiring chemotherapy get treated. That's not all; investors also get data to support the bullish proposition.
Keep in mind that after demonstrating a median survival of 27.9 months in Phase I/II clinical trials vs. 12-15 months reported in historical studies for pancreatic cancer and bile duct cancer patients, RenovoRx secured two separate Orphan Drug Designations from the FDA for intra-arterial gemcitabine. That's a significant value.
And if history can repeat, the same encouraging data could continue to post from its Phase III TIGeR-PaC clinical trial in pancreatic cancer. If so, even with its bullish trend YTD, the path of least resistance for RNXT could be appreciably higher. In other words, with data releases near, RNXT is more than in play; it should stay that way.
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