Acurx Pharmaceuticals (NASDAQ: ACXP) continues to reach milestones. Most recently, they announced expected inclusion into the Russell Microcap® Index. The final list should be out by the end of September. Of course, that brings a whole new set of institutional eyes to the stock. And those investors will like what they see.
In fact,they will likely embrace ACXP's ongoing achievement of its drug development objectives for its pipeline of DNA polymerase IIIC inhibitors. Better still, if its pipeline candidates get approved, ACXP would deliver the first of a new class of antibiotics in over 30 years, potentially opening the floodgates for its antibiotics platform.
And progress is happening at a great pace, with ACXP working towards completing the clinical development program for its lead antibiotic candidate ibezapolstat, targeting the treatment of C. difficile Infection. The better news- the timing of the trial puts several milestones and potential catalysts in play. Some as early as Q4 of this year.
Know this, too. ACXP is among the few companies working to bring meaningful antibiotic treatment candidates to market that target massively underserved gram-positive infections. For patients, ACXP can be a life-saver. For investors, it can be a value driver to portfolios.
Video Link: https://www.youtube.com/embed/9re7gnEfPoA
Targeting Gram-Positive Infections
Indeed, ACXP is in the right market at the right time. Gram-positive infections are deadly, with MRSA, which accounts for 52% of hospitalized patients, to VRE, a condition that has become highly resistant to the current standard of care treatment Vancomycin both debilitating. Worse yet, they are sometimes fatal.
But, adding a level of hope, ACXP is taking action to target and treat these potentially fatal infections. In fact, they are getting industry attention as well, with Health Holland recently providing $500,000 to ACXP in a collaborative venture to evaluate DNA Pol IIIC Inhibitors to treat the conditions. And more than private sector help is coming on board.
Industry-wide calls from the CDC, NIH, BARDA, and CARB-X to treat these underserved infections are getting louder, resulting in potentially more grant funding in the near term. But it's not just the industry agencies paying attention; regulators are too. At least they are to ACXP.
In fact, ACXP's Phase2a results to treat C. difficile were so compelling that regulators allowed for early termination of that trial with a pass directly to a Phase2b study. Hence, ACXP is proving that being disruptive brings advantages. Moving toward its Phase 2b and Phase 3 trial, that could be excellent news for ACXP, patients, and investors.
Long Term Value Proposition
As noted, Acurx's data is impressive. They delivered excellent topline Phase2a trial results to treat EPI in patients with C. difficile. In fact, data was so good that regulators allowed for early termination of its Phase2a arm and a move directly into its Phase 2b study. That allowance saves time, money, and resources. It also puts ACXP a giant step closer to getting an effective treatment for EPI in patients with C. difficile to market.
Better still, if its Phase 2b trial confirms prior results, ACXP could find itself advancing into a Phase 3 trial with best-in-class front-line treatment expectations. ACXP expects to do just that, following its Phase 2a study that demonstrated a 100% success rate in meeting primary and secondary trial endpoints. And with the trial relatively short in duration, with most patients treated and evaluated over a 28-day cycle, that news can come soon. Thus, catalysts are in play.
Still, as compelling as its C. difficile treatment candidate is, ACXP isn't a one-drug opportunity. Instead, they hold data showing its scalable platform can potentially expedite the creation of other drugs to treat additional gram-positive infections.
Those markets, too, are substantial. Further, they also meet an urgent medical need. Hence, there's a lot in play.
Antibiotics Markets In Need Of New Drugs
Its ACX-375C program is also attracting attention. Like ibezapolstat, it targets front-line designation by providing best-in-class effectiveness. Early indicators already show potential to counter numerous multi-drug resistant (MDR) and sensitive gram-positive bacterial pathogens. And despite its pre-clinical status, data shows promise and a reason to pay attention.
The pre-clinical program is a collaborative effort with WuXi App Tec and is one of the few studies evaluating the DNA Pol IIIC inhibitor to treat multiple infections, including Staphylococcus, Streptococcus, and Enterococcal infections. Interim data support that ACX-375C can be effective against more than only those indications, and ACXP expects its treatment profile to extend to numerous other gram-positive resistant bacterial infections.
In fact, ACX-375C platform scalability could open its potential to treat numerous other infections beyond MRSA, VRE, and those mentioned above, including more common indications such as ear and sinus infections, urinary tract infections, bone/joint infections, and pneumonia. Its $500,000 grant from Health Holland may help expedite the collaborative venture. Still, while this program may take into 2022 to get into a more formal clinical setting, updates would be interim value drivers.
Hence, watch for headlines on the program.
Back Half Of 2021
For now, inclusion into the Russell is a value driver that shouldn't go unnoticed. Nor should the tremendous potential value inherent to its ongoing clinical trials. And its not. Prior to the broader market weakness, ACXP was ripping higher, jumping 12% earlier this month. That move higher is well-deserved. Remember, ACXP posted exceptional Phase 2 results in its C. difficile trial, earned expedited advancement to a Phase 2b study, banked grant money to support its trials, and positioned itself to deliver best-in-class front-line treatments to market. That's a four-fold of reasons to like the stock. Weak markets can take away value in the near-term but the long-term proposition is well in play.
Hence, weakness presents opportunity. Moreover, if results from its late-stage Phase 2b trial are as good as expected, prices at these levels will become a relic. And, undoubtedly, by delivering what could be the first meaningful change to the antibiotics market in more than three decades, an appropriate value could double current prices. Peer companies show that to be the case.
Bottom line- market weakness can expose opportunities. ACXP has the same fundamentals and promise as it had last week when investors embraced its ibezapolstat market opportunities. Thus, with this story well intact, ACXP may be presenting a compelling value-investment opportunity. Prices at these levels, however, will likely close once markets bounce back. And in today's market environment, that could be an hour from now.
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