Acurx Pharmaceuticals (NASDAQ: ACXP) is doing something that has been neglected for decades by developing an antibiotics platform that hasn't seen any meaningful upgrades since the 1980s. In fact, already in its Phase 2b trial evaluating ibezapolstat against debilitating conditions, they may be further along than anyone else in the sector. Better still, well-financed after its successful IPO and having only about 9.9 million shares outstanding, ACXP is positioned for potentially explosive growth. Best of all, by focusing on treating conditions that are begging for a better standard of care, that growth can come sooner rather than later.
In fact, ACXP's mission to create shareholder value and develop meaningful drugs for critical unmet and underserved needs is a focused one. They are already accelerating the pace of its Phase2b trial utilizing ibezapolstat as a front-line treatment for C. difficile (CDI), a debilitating germ that causes severe diarrhea and colitis. And investors have been paying attention, sending shares 45% higher intraday to $8.74 following the interim data released earlier this month. Thus, while the stock is hovering around its $6.00 IPO mark, an update from ACXP, if positive, could send shares soaring once again. Even better, ACXP isn't a one-and-done opportunity; they are developing multiple shots on goal in potentially massive markets.
In fact, in collaboration with WuXi AppTec , ACXP is advancing a compelling preclinical development pipeline of antibiotic candidates targeting several high-dollar treatment indications. Moreover, they are in the late-stage processes of completing the manufacturing and formulation of ACX-375C to treat Gram-positive infections. Thus, ACXP is positioned to deliver what many biotech's hope for- near term catalysts.
And that makes investment consideration at these IPO levels a compelling proposition. Better still, with data from its Phase2a CDI trial showing best-in-class results, investment risk appears to be substantially mitigated.
100% Response rate In Phase2a Trial
In fact, Phase2a trial data is about as good as it gets. Using ibezapolstat in patients with CDI, ACXP delivered a 100% cure rate, and 100% sustained clinical cure after 30 days of treatment. Better still, beyond its targeted indication in the trial, ACXP believes the data also exposes an opportunity to leverage the drug applications to target other antibiotic development opportunities created by COVID-19. And with a surge in new infections from potentially hard-to-treat variants, ACXP may be more than timely; they can be lifesavers. In fact, with policymakers worldwide starting to declare a new state of emergency in their countries, the data to date may put ACXP in the queue for some of the new billions of dollars earmarked to find effective treatment candidates.
Still, while COVID-related illness is earning the headlines, the need for a new class of antibiotics to target other indications remains a medical priority. Thus, investors are correct to value ACXP's trials with a sense of investment urgency. After all, if its Phase2b study confirms what's already known, shares could quickly return to all-time highs. In fact, those levels are already in the crosshairs.
And there are excellent reasons to like the data presented. In fact, data from its Phase 2a trial suggests that Acurx is well on its way to replace the current standard of care treating CDI. Its data shows its candidate as ideally positioned to replace the current standard of care that leaves a high burden of C. difficile in the gut that often leads to recurrence of CDI in up to 40% of patients once their therapy stops. ACXP's candidate is compellingly different.
In fact, as noted, its Phase2a trial results were so impressive that regulators allowed for early termination of segment 2a and approved direct advancement to a Phase 2b trial. The even better news is that the trial is relatively short-term compared to traditional drug development studies. Thus, a catalyst could be near.
The new arm of the trial is designed to treat 64 patients over 10 days, with 32 patients dosed ibezapolstat and the remaining 32 patients dosed with Vancomycin, the current standard of care. The excellent news here is that ibezapolstat is going head-to-head with the market leader. If ibezapolstat can best Vancomycin in the final analysis, shares would likely surge even ahead of a Phase 3 trial. Better still, ACXP could tap into several avenues of opportunity, including QIDP and Fast-Track designations, to accelerate regulatory review.
Best of all, if results post as expected, ACXP will be exceptionally well-positioned to capitalize on multiple strategic opportunities, including potential partnerships and licensing opportunity interests. And the best news from an investor's perspective is that an update could be imminent, with the treatment lasting only 10 days. Even better, if results are positive, ACXP heads into its Phase 3 trial with a considerable tailwind at its back.
Keep in mind, too, that indication alone should be worth a multiple of its current market cap. Considering ACXP has much more in the pipeline, pricing even at that high level may be conservative thinking.
A $1.2 Billion CDI Market Alone
That's because the CDI market alone presents a more than $1.2 billion opportunity. But, while a significant opportunity today, that market is expected to become a more than $1.7 billion opportunity within five years. That's a 41% increase to treat an unmet and underserved medical need. Thus, expect regulators to take that into consideration when evaluating the pace of the trial.
Best of all, from an investor's and patient's perspective, ACXP is the favorite to deliver effective first-line treatment to patients with C. difficile, which the CDC and CDI classify as an urgent threat requiring new antibiotic development. In fact, ACXP's data suggest that its drug could be the first to replace decades-old antibiotics with recurrent CDI infection rates of between 20% - 40%.
Keep in mind, too, its Phase2a results treating patients with mild to moderate CDI with orally administered ibezapolstat showed best-in-class results. In fact, ACXP met both primary endpoints of its trial, with all patients dosed with 450mg twice daily for 10 days meeting primary and secondary efficacy endpoints of initial cure and sustained cure. Notably, the treatment was well-tolerated, with no severe adverse reactions reported.
Indeed, at this stage of the trial, it would be foolish to ignore those results. Still, there's more to like.
ACX-375C To Treat MRSA And VRE
ACXP's development stage program is also earning significant attention. That study is evaluating a DNA PolIIIC inhibitor, ACX-375C, to target severe infections, including Staphylococcus, Streptococcus, and Enterococcal infections. Notably, Acurx believes that early data shows promise for the drug to treat other G+ resistant bacterial infections, including VRE and MRSA, both highly debilitating and sometimes fatal conditions.
Better still, ACX-375C also targets a multi-billion dollar market opportunity. In fact, it can meet the demand for several by again replacing decades-old standards of care. Those familiar with hospital-related infections are aware that the potentially fatal MRSA infection accounts for more than 52% of infections in hospitalized patients. Thus, getting effective treatment to market comes with a tremendous sense of urgency. Still, with MRSA a prime target, ACXP expects its drug candidate to be effective against multiple indications.
In fact, ACXP indicates that the drug may be effective in treating more general clinical indications, including urinary tract, hospital-acquired catheter/bloodstream, bone/joint, pneumonia, and ear and sinus infections. Thus, with numerous potential applications and multiple billion-dollar shots on revenue-generating goals, ACX-375C can also be a game-changing asset for the company.
Thus, the bottom line is simple to understand- ACXP has several potentials in its crosshairs. And that should excite investors.
A Company-Changing 2021
In fact, they appear to already be. Despite the post-IPO hangover that often has underwriters weighing on the stock short term, the demand for IPO shares showed that investors like the ACXP story. Better yet, it's apparent they appreciate its trials as well, sending shares more than 45% higher on that day. Now, with only about 9.9 million shares outstanding and a good portion of that in tight hands, the trajectory and bias benefit from bullish sentiment.
Moreover, that optimistic sentiment can get fed relatively soon as data from its ongoing trials nears publication. Better still, ACXP may have plenty to say before that data is tallied, with plans to file for QIDP designation for ACX-375C, start it's Pre-IND Pharm/Tox studies for ACX-375C, file an IND, and seek fast-Track designation for ACX-375C as well. All of those are value-creating milestones. Thus, the next few weeks may be very interesting for shareholders.
In fact, with ACXP showing some of its near-term intentions, trading ahead of the news may be a wise and profitable decision.
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